SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K/A
Amendment
No. 5
x
ANNUAL REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
FOR THE
FISCAL YEAR ENDED DECEMBER 31, 2007
o
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
FOR THE
TRANSITION PERIOD FROM ______ TO _____
COMMISSION
FILE NUMBER 000-551030
OccuLogix,
Inc.
(Exact
name of Registrant as specified in its charter)
DELAWARE
|
59
343 4771
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification
No.)
|
2600
Skymark Avenue, Unit 9, Suite 201
Mississauga,
Ontario L4W 5B2
(Address
of principal executive offices)
(905)
602-0887
(Registrant’s
telephone number, including area code)
SECURITIES
REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
COMMON
STOCK, $0.001 PAR VALUE
(Title of
Class)
SECURITIES
REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes
o
No
x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes
o
No
x
Indicate
by check mark whether the Registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the Registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes
x
No
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of the Registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K/A or any amendment to
this Form 10-K/A.
o
Indicate
by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
o
|
|
Accelerated
filer
x
|
|
|
|
Non-accelerated
filer
o
(Do
not check if a smaller reporting company)
|
|
Smaller
reporting company
o
|
Indicate
by check mark if the Registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes
o
No
x
The
aggregate market value of the voting common stock held by non-affiliates of the
Registrant (assuming officers, directors and 10% stockholders are affiliates),
based on the last sale price for such stock on June 30, 2007: $36,025,308. The
Registrant has no non-voting common stock.
As of
March 13, 2008, there were 57,306,145 shares of the Registrant’s Common Stock
outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the Registrant’s Proxy Statement for the 2008 Annual Meeting of Stockholders
of the Registrant to be held on June 20, 2008 are incorporated by reference into
Part III of this Form 10-K/A.
The
Registrant makes available free of charge on or through its website
(http://www.occulogix.com) its Annual Report on Form 10-K/A, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K and any amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act of 1934. The material is made available through the Registrant’s website as
soon as reasonably practicable after the material is electronically filed with
or furnished to the U.S. Securities and Exchange Commission, or SEC. All of the
Registrant’s filings may be read or copied at the SEC’s Public Reference Room at
100 F Street, N.E., Room 1580, Washington D.C. 20549. Information on the hours
of operation of the SEC’s Public Reference Room can be obtained by calling the
SEC at 1-800-SEC-0330. The SEC maintains a website (
http://www.sec.gov)
that contains reports and proxy and information statements of issuers that file
electronically.
EXPLANATORY
NOTE
OccuLogix,
Inc. (“OccuLogix”, the “Company”, “we”, “us” or “our”) is filing this Amendment
No. 5 (this “Amended Report”) to its Annual Report on Form 10-K for its
fiscal year ended December 31, 2007 (the “Original Filing”), which was
originally filed with the U.S. Securities and Exchange Commission (the “SEC”) on
March 17, 2008 and subsequently supplemented with the filing with the SEC, on
April 29, 2008 of Amendment No. 1 to the Original Filing (“Amendment No.
1”). The Original Filing was subsequently amended with the filing
with the SEC, on July 21, 2008, of Amendment No. 2 to the Original Filing
(“Amendment No. 2”), with the filing with the SEC, on August 21, 2008, of
Amendment No. 3 to the Original Filing (“Amendment No. 3”), and with the filing
with the SEC, on August 26, 2008, of Amendment No. 4 to the Original Filing
(“Amendment No. 4”).
Amendment
No. 1 was filed in order to provide the information required to be provided in
Part III, which information the Original Filing purported to incorporate by
reference to the Company’s Proxy Statement for the 2008 Annual Meeting of
Stockholders of the Company. Amendment No. 2 was filed in order to
restate the Company’s audited consolidated financial statements for the
financial years ended December 31, 2007 and December 31, 2006 and to make
consequential changes to the Original Filing. Amendment No. 3 was
filed in order to: (1) correct a typographical error in the Report of
Independent Registered Public Accounting Firm included in Amendment No. 2; (2)
expand the disclosure in Note 2 (Restatement of Consolidated Financial
Statements) of the Company’s restated audited consolidated financial statements
included in Amendment No. 2 (the “Restated Financial Statements”) in order to
reflect the impact of the restatements on earnings per share; (3) correct a
misclassification, relating to the reconciliation of the recovery of income
taxes, in Note 13 (Income Taxes) of the Restated Financial Statements; and (4)
modify Note 15 (Minority Interest) of the Restated Financial Statements in order
to improve disclosure. Amendment No. 4 was filed in order
to: (1) update the Consent of Independent Registered Public
Accounting Firm, included in Exhibit 23.1 to this Amended Report; and (2) update
the dates of the certifications of the Company’s principal executive officer and
principal financial officer, made pursuant to Section 302 and Section 906 of the
Sarbanes-Oxley Act of 2002 and included in Exhibits 31.1, 31.2, 32.1 and 32.2 to
this Amended Report. This Amended Report is being filed in order to update the
signatures of the directors and officers to the current date.
Except
as stated above, in this Amended Report, we have not modified or updated
disclosures presented in Amendment No. 4 which, in turn, did not modify or
update disclosures presented in Amendment No. 3, which in turn, did not
modify or update disclosures presented in Amendment No. 2 other than as stated
above. Accordingly, this Amended Report does not reflect events
occurring after the Original Filing or modify or update those disclosures
affected by subsequent events, except as specifically referenced herein or in
Amendment No. 2, Amendment No. 3. or Amendment No. 4.
PART
I
SPECIAL
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
Annual Report on Form 10-K/A - amendment No. 5 contains forward-looking
statements relating to future events and the Company’s future performance within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. In some cases,
you can identify forward-looking statements by terms such as “may”, “will”,
“should”, “could”, “would”, “expects”, “plans”, “intends”, “anticipates”,
“believes”, “estimates”, “projects”, “predicts”, “potential” and similar
expressions intended to identify forward-looking statements. These statements
involve known and unknown risks, uncertainties and other factors that may cause
the Company’s actual results, performance or achievements to be materially
different from any future results, performances, time frames or achievements
expressed or implied by the forward-looking statements.
Given
these risks, uncertainties and other factors, you should not place undue
reliance on these forward-looking statements. Information regarding market and
industry statistics contained in this Annual Report on Form 10-K/A is included
based on information available to us that we believe is accurate. It is
generally based on academic and other publications that are not produced for
purposes of securities offerings or economic analysis. We have not reviewed or
included data from all sources and cannot assure you of the accuracy of the
market and industry data we have included.
Unless
the context indicates or requires otherwise, in this Annual Report on Form
10-K/A, references to the “Company” shall mean OccuLogix, Inc. and its
subsidiaries. References to “$” or “dollars” shall mean U.S. dollars unless
otherwise indicated. References to “C$” shall mean Canadian
dollars.
Overview
We are an ophthalmic therapeutic company
founded to
commercializ
e
innovative treatments for
age-related
eye diseases
.
Until recently, the Company
operated two business divisions, being Retina and Glaucoma.
Retina
Division
Until
recently, the Company's Retina division was in the business of
developing and commercializing a treatment for dry age-related macular
degeneration, or Dry AMD. Age-related macular degeneration, or AMD, is the
leading cause of late onset visual impairment and legal blindness in people over
the age of 50 in the United States and other Western industrialized
societies.
We believe that Dry AMD, the most common
form of the disease, afflicts approximately
13.0 to 13.5
million people in the
United States
, representing approximately
85% to 90%
of all AMD cases. Although the exact
cause of AMD is not known, researchers have identified several factors that are
associated with AMD, including poor microcirculation and the gradual build-up of
cellular waste material in the retina. We believe that improved microcirculation
increases the supply of oxygen and nutrients to the compromised retina and
facilitates the removal of cellular waste material from the retina. We believe
that a treatment that improves microcirculation in the retina can help to
enhance the metabolic efficiency of the retina and the removal of waste material
and thereby aid in the treatment of Dry AMD. We believe there is a significant
opportunity for such a treatment.
Our product
for Dry AMD
, the RHEO™ System, is designed to
improve microcirculation in the eye by filtering high molecular weight proteins
and other macromolecules from the patient
’
s plasma. The RHEO™ System is used to
perform the Rheopheresis™ procedure, which we refer to under our trade name
RHEO™ Therapy. The Rheopheresis™ procedure is a blood filtration process that
selectively removes molecules from plasma. The RHEO™ System consists of the
OctoNova Pump and a disposable treatment set, containing two filters, through
which the patient
’
s blood circulates. We believe that the
RHEO™ System is the only Dry AMD treatment to target what we believe to be the
underlying cause of AMD rather than its symptoms and that, based on early data,
appeared to demonstrate improved vision in some patients. The only currently
accepted treatment option for persons with advanced cases of Dry AMD are
over-the-counter vitamins, antioxidants and zinc supplements that can reduce the
five-year risk of conversion to Wet AMD, the other form of the disease, by
approximately 25%.
We conducted a pivotal clinical trial,
called MIRA-1, or Multicenter Investigation of Rheopheresis for AMD, which, if
successful, was expected to support our application to the U.S. Food and Drug
Administration, or FDA, to obtain approval to market the RHEO™ System in the
United States
. On February 3, 2006, we announced
that, based on a preliminary analysis of the data from MIRA-1, MIRA-1 did not
meet its primary efficacy endpoint as it did not demonstrate a statistically
significant difference in the mean change of Best Spectacle-Corrected Visual
Acuity applying the Early Treatment Diabetic Retinopathy Scale, or ETDRS BCVA,
between the treated and placebo groups in MIRA-1 at 12 months post-baseline. As
expected, the treated group demonstrated a positive result. An anomalous
response of the control group is the principal reason why the primary efficacy
endpoint was not met. There were subgroups that did demonstrate statistical
significance in their mean change of ETDRS BCVA versus
control.
Subsequent
to the February 3, 2006 announcement, the Company completed an in-depth analysis
of the MIRA-1 study data identifying subjects that were included in the
intent-to-treat, or ITT, population but who deviated from the MIRA-1 protocol as
well as those patients who had documented losses or gains in vision for reasons
not related to retinal disease such as cataracts. Those subjects in the ITT
population who met the protocol requirements, and who did not exhibit ophthalmic
changes unrelated to retinal disease, comprised the modified per-protocol
population.
In light
of the MIRA-1 study results, we also re-evaluated our Pre-Market Approval
Application, or PMA, submission strategy and then met with representatives of
the FDA, on June 8, 2006 in order to discuss the impact on our PMA submission
strategy of the MIRA-1 study results. In light of MIRA-1’s failure to meet its
primary efficacy endpoint, the FDA advised us that it would require an
additional study of the RHEO™ System to be performed.
On
January 29, 2007, the Company announced that it had obtained Investigational
Device Exemption clearance from the FDA to commence the new pivotal clinical
trial of the RHEO™ System, called RHEO-AMD, or Safety and Effectiveness in a
Multi-center, Randomized, Sham-controlled Investigation for Dry, Non-exudative
Age-Related Macular Degeneration (AMD) Using Rheopheresis.
However,
on November 1, 2007, the Company announced the indefinite suspension of its
RHEO™ System clinical development program. This decision was made following a
comprehensive review of the respective costs and development timelines
associated with the products in the Company's portfolio and in light of the
Company's financial position. Between January 29, 2007 and November 1, 2007, the
Company had prepared the RHEO-AMD protocol and had been putting into place all
of the resources required for the conduct for the RHEO-AMD study, including the
securing of clinical trial site commitments. The Company is in the process of
winding down the RHEO-AMD study as there is no reasonable prospect that the
RHEO™ System clinical development program will be relaunched in the foreseeable
future. Subsequent to our fiscal 2007 year-end, as of February 25,
2008, we have terminated our relationship with Asahi Kasei Kuraray Medical Co.,
Ltd. (formerly Asahi Kasei Medical Co., Ltd.), or Asahi Medical. Asahi Medical
manufactures, and supplied us with, the Rheofilter filter and the Plasmaflo
filter, both of which are key components of the RHEO™ System. We also are
engaged in discussions with Diamed Medizintechnik GmbH, or Diamed, and MeSys
GmbH, or MeSys, regarding the termination of our relationship with each of
them. Diamed is the designer, and MeSys is the manufacturer, of the
OctoNova pump, another key component of the RHEO™ System.
Glaucoma
Division
In
anticipation of the delay in the commercialization of the RHEO™ System in the
United States as a result of the MIRA-1 study’s failure to meet its primary
efficacy endpoint and the FDA’s requirement of us to conduct an additional study
of the RHEO™ System, the Company accelerated its diversification plans and, on
September 1, 2006, acquired Solx, Inc., or SOLX, a Boston University Photonics
Center-incubated company that has developed a system for the treatment of
glaucoma, called the SOLX Glaucoma System.
The SOLX
Glaucoma System is a next-generation glaucoma treatment platform designed to
reduce intra-ocular pressure, or IOP, without a bleb (which is a surgically
created flap that serves as a drainage pocket underneath the surface of the
eye), thus avoiding its related complications. The SOLX Glaucoma System consists
of the SOLX 790 Laser, a titanium sapphire laser used in laser trabeculoplasty
procedures, and the SOLX Gold Shunt, a 24-karat gold, ultra-thin drainage device
designed to bridge the anterior chamber and the suprachoroidal space in the eye,
using the pressure differential that exists naturally in the eye in order to
reduce IOP.
On
December 20, 2007, we announced the sale of SOLX to Solx Acquisition, Inc., or
Solx Acquisition, a company wholly owned by Doug P. Adams, the founder of SOLX
and who, until the closing of the sale, had been serving as an executive officer
of the Company in the capacity of President & Founder, Glaucoma
Division.
The
consideration for the purchase and sale of all of the issued and outstanding
shares of the capital stock of SOLX consisted of: (i) on December 19,
2007, the closing date of the sale, the assumption by Solx Acquisition of all of
the liabilities of OccuLogix, as they related to SOLX’s business, incurred on or
after December 1, 2007, and OccuLogix’s obligation to make a $5,000,000 payment
to the former stockholders of SOLX due on September 1, 2008 in satisfaction of
the outstanding balance of the purchase price of SOLX; (ii) on or prior to
February 15, 2008, the payment by Solx Acquisition of all of the expenses that
OccuLogix had paid to the closing date, as they related to SOLX’s business
during the period commencing on December 1, 2007; (iii) during the period
commencing on the closing date and ending on the date on which SOLX achieves a
positive cash flow, the payment by Solx Acquisition of a royalty equal to 3% of
the worldwide net sales of the SOLX 790 Laser and the SOLX Gold Shunt, including
next-generation or future models or versions of these products; and (iv)
following the date on which Solx achieves a positive cash flow, the payment by
Solx Acquisition of a royalty equal to 5% of the worldwide net sales of these
products. In order to secure the obligation of Solx Acquisition to make these
royalty payments, SOLX granted to OccuLogix a subordinated security interest in
certain of its intellectual property. In connection with the sale of SOLX, those
employees of the Company, whose roles and responsibilities related mainly to
SOLX’s business, ceased to be employees of the Company and became employees of
Solx Acquisition or SOLX.
Prior to
the sale of SOLX, we had been in the process of training and certifying
physicians in the use of the SOLX Gold Shunt, for commercial purposes, in
various European and Asian jurisdictions, including Spain, Italy, Germany,
Poland, France, the United Kingdom and Thailand. In addition, in order to
establish and maintain a reliable distribution network for SOLX’s products, we
had been continuing to maintain our relationships with distributors in France,
Germany, Spain, the United Kingdom and Canada and had been engaged in pursuing
relationships with other distributors in Europe.
Both the
SOLX 790 Laser and the SOLX Gold Shunt are currently the subject of randomized,
multi-center clinical trials, the purposes of which are to demonstrate
equivalency to the argon laser, in the case of the SOLX 790 Laser, and to the
Ahmed Glaucoma Valve manufactured by New World Medical, Inc., in the case of the
SOLX Gold Shunt. The results of these clinical trials will be used in support of
applications to the FDA for a 510(k) clearance for each of the SOLX 790 Laser
and the SOLX Gold Shunt, the receipt of which, if any, will enable the marketing
and sale of these products in the United States.
The SOLX
790 Laser received CE Mark approval in December 2004, and the SOLX Gold Shunt
received CE Mark approval in October 2005. The SOLX 790 Laser has a Health
Canada license, and, prior to the sale of SOLX, we had been seeking the
corresponding approval for the SOLX Gold Shunt.
OcuSense,
Inc.
As part
of its accelerated diversification plans, on November 30, 2006, OccuLogix
acquired 50.1% of the capital stock, on a fully diluted basis, 57.62% on an
issued and outstanding basis, of OcuSense, Inc., or OcuSense, a San Diego-based
company that is in the process of developing technologies that will enable eye
care practitioners to test, at the point-of-care, for highly sensitive and
specific biomarkers using nanoliters of tear film.
OcuSense’s
first product, which is currently under development, is a hand-held tear film
test for the measurement of osmolarity, a quantitative and highly specific
biomarker that has shown to correlate with dry eye disease, or DED, The test is
known as the TearLab™ test for DED. The anticipated innovation of the TearLab™
test for DED will be its ability to measure precisely and rapidly certain
biomarkers in nanoliter volumes of tear samples, using inexpensive
hardware. Historically, eye care researchers have relied on expensive
instruments to perform tear biomarker analysis. In addition to their cost, these
conventional systems are slow, highly variable in their measurement readings and
not categorized as waived by the FDA under regulations promulgated under the
Clinical Laboratory Improvement Amendments, or CLIA.
The
TearLab™ test for DED will require the development of the following three
components: (1) the TearLab™ disposable, which is a single-use
microfluidic labcard; (2) the TearLab™ pen, which is a hand-held device that
interfaces with the TearLab™ disposable; and (3) the TearLab™ reader, which is a
small desktop unit that allows for the docking of the TearLab™ disposable and
the TearLab™ pen and provides a quantitative reading for the
operator. OcuSense is currently engaged in industrial, electrical and
software design efforts for the three components of the TearLab™ test for DED
and, to these ends, is working with two engineering partners, both based in
Melbourne, Australia, one of which is a leader in biomedical instrument
development and the other of which is a leader in customized
microfluidics.
OcuSense’s
objective is to complete product development of the TearLab™ test for DED during
the first half of 2008. Following the completion of product development and
subsequent clinical trials, OcuSense intends to seek a 510(k) clearance and a
CLIA waiver from the FDA for the TearLab™ test for DED. Currently, it
anticipates seeking the 510(k) clearance during the latter half of 2008 and the
CLIA waiver during the latter half of 2009. In addition, OcuSense intends to
seek CE Mark approval for the TearLab™ test for DED during the latter half of
2008.
OccuLogix
acquired its 50.1% ownership stake, on a fully diluted basis, 57.62% on an
issued and outstanding basis, in OcuSense for an aggregate purchase price of up
to $8,000,000. Pursuant to the Series A Preferred Stock Purchase Agreement,
dated as of November 30, 2006, by and among OcuSense and the Company (which
agreement was amended subsequently on October 29, 2007), or the OcuSense Stock
Purchase Agreement, the Company purchased 1,754,589 shares of OcuSense’s Series
A Preferred Stock, par value $0.001 per share. The Company paid $2,000,000 of
the purchase price on the closing of the purchase and made another $2,000,000
payment on January 3, 2007. A third $2,000,000 payment was made in June 2007
upon the attainment by OcuSense of the first of two pre-defined milestones, and
the last $2,000,000 installment of the purchase price will become due and
payable upon the attainment by OcuSense of the second of these two pre-defined
milestones, being the successful production and testing of Beta Lab Cards for
Osmolarity and the Beta Reader for Osmolarity, or the TearLab™ disposable and
the TearLab™ reader, respectively. OcuSense attained this second milestone at
the end of the first quarter of 2008.
The
OcuSense Stock Purchase Agreement provides for an ability on the part of the
Company to increase its ownership interest in OcuSense for nominal consideration
if OcuSense fails to meet certain other milestones by specified dates. In
addition, pursuant to the OcuSense Stock Purchase Agreement, the Company has
agreed to purchase $3,000,000 of shares of OcuSense’s Series B Preferred Stock
upon OcuSense’s receipt from the FDA, if any, of 510(k) clearance for the
TearLab™ test for DED and to purchase another $3,000,000 of shares of OcuSense’s
Series B Preferred Stock upon OcuSense’s receipt from the FDA, if any, of a CLIA
waiver for the TearLab™ test for DED.
Current
Situation
With the
suspension of the Company's RHEO™ System clinical development program, and the
consequent winding-down of the RHEO-AMD study, and the Company's disposition of
SOLX, the Company no longer has any operating business. Its major asset is its
50.1% ownership stake, on a fully diluted basis, 57.62% on an issued and
outstanding basis, in OcuSense.
On
October 9, 2007, we announced that the Company's Board of Directors, or the
Board, had authorized management and our advisors to explore the full range of
strategic alternatives available to enhance stockholder value. These
alternatives may include, but are not limited to, the raising of capital through
the sale of securities, one or more strategic alliances and the combination,
sale or merger of all or part of OccuLogix. In making the announcement, the
Company stated that there can be no assurance that the exploration of strategic
alternatives will result in a transaction. To date, we have not disclosed, nor
do we intend to disclose, developments with respect to our exploration of
strategic alternatives unless and until the Board, has approved a specific
transaction.
For some
time prior to the October 9, 2007 announcement, the Company had been seeking to
raise additional capital, with the objective of securing funding sufficient to
sustain its operations as it has been clear that, unless we were able to raise
additional capital, the Company would not have had sufficient cash to support
its operations beyond early 2008. The Board’s decisions to suspend the Company's
RHEO™ System clinical development program and to dispose of SOLX were made and
implemented in order to conserve as much cash as possible while the Company
continues its capital-raising efforts.
On
January 9, 2008, we announced the departure, or pending departure, of seven
members of our executive team and, commencing on February 1, 2008, a 50%
reduction in the salary of each of Elias Vamvakas, our Chairman and Chief
Executive Officer, and Tom Reeves, our President and Chief Operating Officer. By
January 31, 2008, a total of 12 non-executive employees of the Company left the
Company's employment.
On
February 19, 2008, we announced that the Company secured a bridge loan in an
aggregate principal amount of $3,000,000 from a number of private parties. The
loan bears interest at a rate of 12% per annum and has a 180-day term, which may
be extended to 270 days under certain circumstances. The repayment of the loan
is secured by a pledge by the Company of its shares of the capital stock of
OcuSense.
Under the
terms of the loan agreement, the Company has two pre-payment options available
to it, should it decide to not wait until the maturity date to repay the loan.
Under the first pre-payment option, the Company may repay the loan in full by
paying the lenders, in cash, the amount of outstanding principal and accrued
interest and issuing to the lenders five-year warrants in an aggregate amount
equal to approximately 19.9% of the issued and outstanding shares of the
Company's common stock (but not to exceed 20% of the issued and outstanding
shares of the Company's common stock). The warrants would be exercisable into
shares of the Company's common stock at an exercise price of $0.10 per share and
would not become exercisable until the 180
th
day
following their issuance. Under the second pre-payment option, provided that the
Company has closed a private placement of shares of its common stock for
aggregate gross proceeds of at least $4,000,000, the Company may repay the loan
in full by issuing to the lenders shares of its common stock, in an aggregate
amount equal to the amount of outstanding principal and accrued interest, at a
15% discount to the price paid by the private placement investors. Any exercise
by the Company of the second pre-payment option would be subject to stockholder
and regulatory approval.
Currently,
we anticipate that the net proceeds of the loan, together with the Company's
other cash and cash-equivalents, will be sufficient to sustain the Company's
operations only until approximately the end of April 2008 (assuming that the
outstanding obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due
and payable prior to the end of April 2008).
Our History and Major
Relationships
Shortly after our inception, we began
commercialization of therapeutic apheresis by opening a therapeutic apheresis
center in
Florida
. This site generated revenues of
$900,200 and $1,277,800 for the years ended June 30, 1999 and 1998,
respectively. The therapeutic apheresis center was closed in 1999 pursuant to a
directive issued by the FDA. After obtaining an FDA investigational device
exemption in 1999, we initiated the MIRA-1 pivotal clinical trial to support an
application to the FDA for approval to market the RHEO™ System and completed
this trial in 2005.
Relationship with TLC Vision
Corporation
TLC
Vision Corporation, or TLC Vision, beneficially owns approximately 32.8% of our
outstanding common stock, or 28.9% on a fully diluted basis. Elias Vamvakas,
formerly a director of TLC Vision and its past Chairman and CEO, became our
Chairman in 2003 and is also our CEO. In addition, one of our other directors,
Richard L. Lindstrom, is also a director of TLC Vision. One of our other
directors, Thomas N. Davidson, also was a director of TLC Vision until December
2007. Mr. Vamvakas beneficially owns 1,041,795 common shares of TLC Vision,
representing approximately 2.08% of TLC Vision’s outstanding shares. Mr.
Davidson beneficially owns 67,127 common shares of TLC Vision, representing
approximately 0.14% of TLC Vision’s outstanding shares, and Dr. Lindstrom
beneficially owns 29,500 common shares of TLC Vision, representing approximately
0.06% of TLC Vision’s outstanding shares.
On
December 8, 2004, we purchased TLC Vision’s 50% interest in OccuLogix, L.P.
in exchange for which we issued
19,070,234 shares of our common stock to TLC Vision.
This resulted in
OccuLogix, L.P. becoming our wholly-owned subsidiary. Accordingly, 100% of the
results of OccuLogix, L.P.’s operations are included in the consolidated
financial statements since that date. We licensed to OccuLogix, L.P. all of the
distribution and marketing rights for the RHEO™ System for ophthalmic
indications to which we are entitled. Prior to the acquisition, our only profit
stream had come from our share of OccuLogix, L.P.’s earnings. Our acquisition of
TLC Vision’s 50% ownership interest in OccuLogix, L.P. transferred the earnings
potential for sales of the RHEO™ System entirely to us.
As part of the formation of OccuLogix,
L.P. in July 2002, we licensed certain patent rights, trademark rights and
know-how rights to OccuLogix, L.P. We also provided OccuLogix, L.P. with
licenses to our in-house software as well as sublicensing software that we have
licensed from TLC Vision. TLC Vision agreed to provide OccuLogix, L.P., upon
request, with $200,000 in funding at an annual interest rate equal to the Bank
of America prime rate of interest on the date the loan is made, plus two
percent. As at December 8, 2004, Occulogix, L.P. had not requested funding from
TLC Vision.
On December 31, 2005, OccuLogix, L.P.
transferred all of its assets and liabilities, including the licensed patent,
trademark and know-how rights and the licensed distribution and marketing rights
for the RHEO™ System, to our
then
newly incorporated subsidiary, OccuLogix
Canada Corp. We
completed
the wind-up of OccuLogix, L.P.
on February 6, 2006.
Whatever residual
value
exists with respect to the
RHEO™ System
resides solely
in OccuLogix Canada Corp.
On June
22, 2007, TLC Vision sold 1,904,762 shares of OccuLogix’s common stock to JEGC
OCC Corp., or JEGC. JEGC is owned by Greybrook Corporation, a private equity
firm controlled by Mr. Vamvakas, and by Jefferson Equicorp Ltd., a private
equity firm controlled by David Folk, Managing General Partner of Jefferson
Partners.
Other Major
Relationships
The
components of the RHEO™ System were developed by our suppliers, Diamed and Asahi
Medical.
Prior to
the Company's acquisition of SOLX, Doug P. Adams served as the President and
Chief Executive Officer of SOLX and was a significant stockholder of SOLX.
Between September 1, 2006, the closing date of the acquisition, and December 19,
2007, the closing date of OccuLogix’s sale of SOLX to Solx Acquisition, Mr.
Adams served as an executive officer of the OccuLogix. OccuLogix paid Mr. Adams
a total of $1,615,930 and issued to him 1,309,329 shares of our common stock in
consideration of his proportionate share of the purchase price of SOLX. Until
the assumption, on December 19, 2007, by Solx Acquisition of OccuLogix’s
obligation to pay $5,000,000 to the former stockholders of SOLX on September 1,
2008 in satisfaction of the outstanding balance of the purchase price of SOLX,
Mr. Adams was owed $1,024,263
by OccuLogix in
consideration of his proportionate share of the outstanding balance of the
purchase price of SOLX.
In
addition, in connection with the Company's acquisition of SOLX, OccuLogix paid
Peter M. Adams, Doug P. Adams’ brother, a total of $371,095
and issued to him and
his spouse an aggregate of 300,452 shares of our common stock in consideration
of his proportionate share of the purchase price of SOLX. Until the assumption,
on December 19, 2007, by Solx Acquisition of OccuLogix’s obligation to pay
$5,000,000 to the former stockholders of SOLX on September 1, 2008 in
satisfaction of the outstanding balance of the purchase price of SOLX, OccuLogix
owed Mr. Adams $236,917 in consideration of his proportionate share of the
outstanding balance of the purchase price of SOLX.
On
November 30, 2006, Mr. Vamvakas agreed to provide the Company with a standby
commitment to purchase convertible debentures of the Company in an aggregate
maximum principal amount of up to $8 million. When the Company raised gross
proceeds in the amount of $10,016,000 on February 6, 2007 in a private placement
of shares of its common stock and warrants, the commitment amount under Mr.
Vamvakas’ standby commitment was reduced to zero, thus effectively terminating
the standby commitment. No portion of the standby commitment was ever drawn down
by the Company, and the Company has paid Mr. Vamvakas a total of $29,808 in
commitment fees.
On
December 19, 2007, we sold SOLX to Solx Acquisition, Inc., a company wholly
owned by Doug P. Adams. The consideration for the purchase and sale of all of
the issued and outstanding shares of the capital stock of SOLX consisted
of: (i) on December 19, 2007, the closing date of the sale, the
assumption by Solx Acquisition of all of the liabilities of OccuLogix, as they
related to SOLX’s business, incurred on or after December 1, 2007, and
OccuLogix’s obligation to make a $5,000,000 payment to the former stockholders
of SOLX due on September 1, 2008 in satisfaction of the outstanding balance of
the purchase price of SOLX; (ii) on or prior to February 15, 2008, the payment
by Solx Acquisition of all of the expenses that OccuLogix had paid to the
closing date, as they related to SOLX’s business during the period commencing on
December 1, 2007; (iii) during the period commencing on the closing date and
ending on the date on which SOLX achieves a positive cash flow, the payment by
Solx Acquisition of a royalty equal to 3% of the worldwide net sales of the SOLX
790 Laser and the SOLX Gold Shunt, including next-generation or future models or
versions of these products; and (iv) following the date on which Solx achieves a
positive cash flow, the payment by Solx Acquisition of a royalty equal to 5% of
the worldwide net sales of these products. In order to secure the obligation of
Solx Acquisition to make these royalty payments, SOLX granted to OccuLogix a
subordinated security interest in certain of its intellectual
property.
Marchant
Securities Inc., or Marchant, a firm indirectly beneficially owned as to
approximately 32% by Mr. Vamvakas and members of his family, introduced the
Company to the lenders of the $3,000,000 aggregate principal amount bridge loan
that the Company secured and announced on February 19, 2008. For such service,
Marchant will be paid a commission of $180,000, being 6% of the aggregate
principal amount of the loan. Subject to obtaining any and all requisite
stockholder and regulatory approvals, half of the commission will be paid to
Marchant in the form of equity securities of the Company.
Industry
(OcuSense)
Point-of-care
Testing and Dry Eye Disease, or DED
The
global market for point-of-care testing is currently $4.5 billion annually or
15% of the $30 billion global market for in-vitro diagnostic products.
Approximately 75% of all laboratory tests today are performed at centralized
clinical laboratories. However, there is an increasing frequency of diagnostic
testing being performed at the point-of-care due to several factors, including a
need for rapid testing in acute care situations, the benefits of patient
monitoring and disease management, streamlining therapeutic decision making and
the overall trend toward personalized medicine. Advances in biodetection
technologies that can simplify and accelerate the rate of performing complex
diagnostic tests at the point-of-care, and that are reimbursed, will drive
utilization and overall point-of-care testing market growth.
OcuSense’s
first product, currently under development, is the TearLab™ test for DED which
is a test that can be performed at the point-of-care for the measurement of
osmolarity, a quantitative and highly specific biomarker that has shown to
correlate with DED. There are estimated to be more than 30 million people with
DED in the U.S. alone, and this condition is estimated to account for up to
one-third of all visits to U.S. doctors.
Each time
a person blinks, his or her eyes are resurfaced with a thin layer of a complex
fluid known as the tear film. The tear film works to protect eyes from the
outside world. Bacteria, viruses, sand, freezing winds and salt water will not
damage eyes when the tear film is intact. However, when compromised, a deficient
tear film can be an exceedingly painful and disruptive experience. The tear film
consists of three components: (i) an innermost mucin layer (produced
by the surface cells); (ii) the aqueous layer (the water in tears, produced by
the lacrimal gland); and (iii) an oily lipid layer which limits evaporation of
the tears (produced by the meibomian glands, located at the margins of the
eyelids). The apparatus of the ocular surface forms an integrated unit. When
working correctly, the tear film presents a smooth optical surface essential for
clear vision and proper immunity. However, when the tear film is disrupted, it
leads to the condition known as DED.
DED is
often seen as a result of aging, diabetes, prostate cancer therapy, HIV,
autoimmune diseases such as Sjögren’s syndrome and rheumatoid arthritis, LASIK
surgery, contact lens wear and menopause and as a side effect of hormone
replacement therapy. Numerous commonly prescribed and over-the-counter
medications also can cause, or contribute to, the manifestation of
DED.
As an
individual’s lacrimal glands deteriorate with age or disease, the quantity of
tears is drastically reduced, resulting in an aqueous deficiency. Other forms of
DED are linked to meibomian gland (lid) dysfunction, where a patient’s tears
evaporate so quickly that he or she is unable to retain any moisture on the
surface of his or her eye. The end effect in both cases, aqueous deficiency and
evaporative dry eye, is a very debilitating condition that results in pain,
decreased vision and, in severe cases, even blindness. Consequently, DED has a
significant negative impact on one’s quality of life.
There are
approximately 15 million Americans who suffer from contact lens-induced DED, and
10-15% of these patients revert to frame wear annually due to dryness and
discomfort. There are approximately 1.2 million LASIK procedures performed in
the U.S each year, and about 50% of patients experience DED post-operatively.
Osmolarity testing could provide optometrists with a tool to identify patients
at risk for dropping out of contact lens wear early in disease progression so
that they may be treated, and osmolarity testing could be an invaluable
pre-operative screen used to determine which LASIK patients should be treated
prior to surgery in order to improve post-operative outcomes.
Diagnostic
Alternatives for DED
Existing
diagnostic assays are highly subjective, do not correlate well with symptoms,
are invasive for patients and may require up to an hour of operator time to
perform. All of these factors have constrained the diagnosis and treatment of
the DED patient population. As physicians have not had access to objective,
quantitative diagnostic assays that correlate well with symptoms and disease
pathogenesis, it has been difficult for them to differentiate DED symptoms from
other eye diseases that present with very similar symptoms, such as
non-infectious ocular allergies or infectious bacterial or viral diseases. To
treat DED effectively and to mitigate the emotional and physical effects of this
disease, it will be critical to equip physicians with objective, quantitative
measurements of disease pathogenesis so they can determine more accurately the
most efficacious treatments for their patients.
DED
presents itself as an increase in the salt concentration of the tear film. For
approximately 50 years, studies have shown that tear film osmolarity is an ideal
clinical marker for diagnosing DED, because it provides an objective,
quantitative measurement of disease pathogenesis. Moreover, measuring osmolarity
could serve as an effective disease management tool by providing physicians with
an ability to personalize therapeutic intervention and to track patient outcomes
quantitatively. However, measuring tear biomarkers, such as osmolarity, at the
point-of-care requires a reduction in sample volume to the nanoliter scale in
order to mitigate the risk of reflex tearing, which results in a dilution of the
tear sample and a variability in the test results. Moreover, a point-of-care
system in the U.S. market most likely would require a CLIA waiver classification
in order to gain broad market adoption since most U.S. eye care practitioners do
not possess CLIA certification for their offices. In order to be given CLIA
waiver classification, the user interface of the test would have to be extremely
simple in order to minimize the likelihood of operator error and the risk of
harm to the patient. Conventional technologies for the measurement of osmolarity
are not suitable for the point-of-care market as they are too expensive, too
complex for CLIA waiver classification and unable to measure precisely tear film
osmolarity in nanoliter sample volumes. OcuSense is striving to meet the needs
of the point-of-care market with the TearLab™ test for DED.
Existing
osmometry technologies have proven unable to measure consistently tear samples
in the low nanoliter range, which has presented a critical barrier to their
entry into the DED diagnostic markets. In addition, these instruments are not
particularly suitable for use in a physician’s office, since they require
continual calibration, cleaning and maintenance. Existing osmometers currently
are marketed primarily to reference and hospital laboratories for the
measurement of osmolarity in blood, urine and other serum samples.
OcuSense’s
Product
OcuSense’s
first product, the TearLab™ test for DED, which is currently under development,
is an integrated testing system comprised of: (1) the TearLab™
disposable, which is a single-use microfluidic labcard; (2) the TearLab™ pen,
which is a hand-held device that interfaces with the TearLab™ disposable; and
(3) the TearLab™ reader, which is a small desktop unit that allows for the
docking of the TearLab™ disposable and the TearLab™ pen and provides a
quantitative reading for the operator. The anticipated innovation of the
TearLab™ test for DED will be its ability to measure precisely and rapidly, and
inexpensively, certain biomarkers in nanoliter volumes of tear samples. Current
in-lab testing technologies require a minimum of one microliter volume tear film
sample, or approximately 10 to 100 times more than the tear film volume
typically available before reflex tearing occurs.
The
operator of the TearLab™ test for DED, most likely a technician, will collect
the tear sample from the patient’s eye in the TearLab™ disposable, using the
TearLab™ pen, and then place the TearLab™ disposable into the TearLab™ reader.
The TearLab™ reader then will display an osmolarity reading to the operator.
Following the completion of the test, the TearLab™ disposable will be discarded
and a new TearLab™ disposable will be readied for the next test. The entire
process, from sample to answer, should require approximately two minutes or less
to complete.
OcuSense
is currently engaged in industrial, electrical and software design efforts for
the three components of the TearLab™ test for DED and, to these ends, is working
with two engineering partners, both based in Melbourne, Australia, one of which
is a leader in biomedical instrument development and the other of which is a
leader in customized microfluidics. In June 2007, OcuSense successfully produced
and tested Alpha prototypes of the TearLab™ disposable, pen and reader in order
to demonstrate the viability of the integrated system. OcuSense is working to
achieve the successful production and testing of Beta prototypes of the TearLab™
disposable, pen and reader in order to validate system performance further and
to prepare for commercial manufacturing. We anticipate that this milestone will
be attained during the first half 2008.
OcuSense’s
objective is to complete product development of the TearLab™ test for DED during
the first half of 2008. Following the completion of product development and
subsequent clinical trials, OcuSense intends to seek a 510(k) clearance and a
CLIA waiver from the FDA for the TearLab™ test for DED. Currently, it
anticipates seeking the 510(k) clearance during the latter half of 2008 and the
CLIA waiver during the latter half of 2009.
In addition, OcuSense
intends to seek CE Mark approval for the TearLab™ test for DED during the latter
half of 2008.
In
December 2007, OcuSense entered into a research agreement with a large
ophthalmic company, pursuant to which that company is sponsoring OcuSense’s
clinical studies of the TearLab™ test for DED. Pursuant to this research
agreement, that company has paid for the future acquisition of a number of units
of the beta version of the TearLab™ test for DED and has secured limited
exclusive access to the beta version of the TearLab™ test for DED until OcuSense
obtains a 510(k) clearance for it from the FDA.
Competition
(OcuSense)
To date,
OcuSense has identified one emerging technology that claims to be able to
measure the osmolarity of nanoliter tear samples. This technology is being
developed at the Aborn Eye Clinic in New York. Based on patent claims, it would
appear that this technology uses surface plasmon resonance, an optical
technology, to measure tear film osmolarity.
As there
are no commercially available instruments to measure tear film osmolarity at the
point-of-care, OcuSense views existing DED diagnostic tests, such as the
Schirmer Test and ocular surface staining, as its primary source of
competition.
Tear film
break-up time, or TBUT, is another assay meant as an indication of tear film
stability. However, it is subjective, requires a physician to instill
a carefully controlled amount of fluorescein dye into the eye and requires a
stopwatch to determine the endpoint. TBUT has been shown to be unreliable as a
determinant of DED since shortened TBUT doesn’t always correlate well with other
signs or symptoms.
Tests
like impression cytology and corneal staining, although indicative of relatively
late stage phenomena in DED, are subjective, qualitative and generally don’t
correlate to disease pathogenesis. The Schirmer Test is an imprecise
marker of tear function since its diagnostic results vary
significantly.
Although,
at the present time, there does not appear to be a direct competitor to the
TearLab™ test for DED, many industry participants have much greater resources
than OcuSense has, thus enabling them, among other things, to make greater
research and development investments, and to make more significant investments
in marketing, promotion and sales, than OcuSense is capable of right now or will
be capable of during the foreseeable future.
Patents
and Proprietary Rights (OcuSense)
OcuSense
owns or has exclusive licenses to five U.S. patents relating to the TearLab™
test for DED and related technology and processes and has applied for a number
of other patents in the United States and other jurisdictions.
OcuSense
intends to rely on know-how, continuing technological innovation and
in-licensing opportunities to develop further its proprietary position.
OcuSense’s ability to obtain intellectual property protection for the TearLab™
test for DED and related technology and processes, and its ability to operate
without infringing the intellectual property rights of others and to prevent
others from infringing its intellectual property rights, will have a substantial
impact on its ability to succeed in its business. Although OcuSense intends to
seek to protect its proprietary position by, among other methods, continuing to
file patent applications, the patent position of companies like OcuSense is
generally uncertain and involves complex legal and factual questions. OcuSense’s
ability to maintain and solidify a proprietary position for its technology will
depend on its success in obtaining effective claims and enforcing those claims
once granted. Neither OcuSense nor we know whether any part of its patent
applications will result in the issuance of any patents. Its issued patents or
those that may issue in the future, or those licensed to OcuSense, may be
challenged, invalidated or circumvented, which could limit OcuSense’s ability to
stop would-be competitors from marketing tests identical to the TearLab™ test
for DED.
In
addition to patent protection, OcuSense has registered the TearLab™ trademark in
the U.S.
Government
Regulation
Government
authorities in the United States and other countries extensively regulate, among
other things, the research, development, testing, manufacture, labeling,
promotion, advertising, distribution and marketing of OcuSense’s product, which
is a medical device. In the United States, the FDA regulates medical devices
under the Federal Food, Drug, and Cosmetic Act and implementing regulations.
Failure to comply with the applicable FDA requirements, both before and after
approval, may subject us to administrative and judicial sanctions, such as a
delay in approving or refusal by the FDA to approve pending applications,
warning letters, product recalls, product seizures, total or partial suspension
of production or distribution, injunctions, administrative fines and/or criminal
prosecution.
Unless exempted by regulation, medical
devices may not be commercially distributed in the
United States
unless they have been cleared or
approved by the FDA. Medical devices are classified into one of the three
classes, Class I, II or III, on the basis of the controls necessary to
reasonably assure their safety and effectiveness. Class I devices are subject to
general controls, such as labeling, pre
-
market notification and adherence to
good manufacturing practices. Class II devices are subject to general and
specific controls, such as performance standards, pre-market notification,
patient registries and FDA guidelines. Generally, Class III devices are those
which must receive approval of a PMA by the FDA to provide reasonable assurance
of their safety and effectiveness. For example, life-sustaining, life-supporting
and implantable devices, or new devices which have not been found substantially
equivalent to legally marketed devices, generally require approval of a PMA by
the FDA.
There are two review procedures by which
medical devices can receive clearance or approval. Some products may qualify for
clearance under a Section 510(k) procedure, in which the manufacturer provides a
pre
-
market notification that it intends to
begin marketing the product, and shows that the product is substantially
equivalent to another legally marketed product, that it has the same intended
use and is as safe and effective as a legally marketed device and does not raise
different questions of safety and effectiveness than does a legally marketed
device. In some cases, the submission must include data from human clinical
studies. Marketing may commence when the FDA issues a clearance letter finding
substantial equivalence.
By
statute and regulation, the FDA is required to clear, deny or request additional
information on a 510(k) pre-market notification within 90 days of its
submission. However, as a practical matter, 510(k) clearance often takes
significantly longer. The FDA may require additional information, including
clinical data, to make a determination regarding substantial equivalence. In
addition, after a device receives 510(k) clearance, any modification to the
device that could significantly affect its safety or effectiveness, or that
would constitute a major change in its intended use, would require a new 510(k)
clearance or an approval of a PMA. Although the FDA requires the manufacturer to
make the initial determination regarding the effect of a modification to the
device that is subject to 510(k) clearance, the FDA can review the
manufacturer’s determination at any time and require the manufacturer to seek
another 510(k) clearance or an approval of a PMA.
The
TearLab™ test for DED is a Class I, non-exempt device and qualifies for the
510(k) procedure.
CLIA is
intended to ensure the quality and reliability of clinical laboratories in the
United States by mandating specific standards in the areas of personnel
qualifications, administration, participation in proficiency testing, patient
test management, quality control, quality assurance and inspections. The
regulations promulgated under CLIA establish three levels of in vitro diagnostic
tests: (1) waiver; (2) moderately complex; and (3) highly complex.
The standards applicable to a clinical laboratory depend on the level of
diagnostic tests it performs. A CLIA waiver is available to clinical laboratory
test systems if they meet certain requirements established by the statute.
Waived tests are simple laboratory examinations and procedures employing
methodologies that are so simple and accurate as to render the likelihood of
erroneous results negligible or to pose no reasonable risk of harm to patients
if the examinations or procedures are performed incorrectly. These tests are
waived from regulatory oversight of the user other than the requirement to
follow the manufacturer’s labeling and directions for use.
We cannot
be sure of when, or whether, OcuSense will be successful in obtaining a 510(k)
clearance or a CLIA waiver for the TearLab™ test for DED.
If the medical device does not qualify
for the 510(k) procedure, either because it is not substantially equivalent to a
legally marketed device or because it is a Class III device required to have an
approved PMA, then the FDA must approve a submitted PMA before marketing can
begin. A PMA must demonstrate, among other matters, that the medical device is
safe and effective. A PMA is typically a complex submission, usually including
the results of preclinical and clinical studies, and preparing an application is
a detailed and time-consuming process. The PMA must be accompanied by the
payment of user fees which currently exceed $200,000 for most submissions. When
modular submissions are used, the entire fee is due when the first module is
submitted to the FDA. Once a PMA has been submitted, the FDA
’
s review may be lengthy and may include
requests for additional data. The FDA usually inspects device manufacturers
before approval of a PMA, and the FDA will not approve the PMA unless the
manufacturer
’
s compliance with the quality systems
regulation is satisfactory.
Regardless of whether a medical device
requires FDA clearance or approval, a number of other FDA requirements apply to
the device, its manufacturer and those who distribute it. Device manufacturers
must be registered and their products listed with the FDA, and certain adverse
events and product malfunctions must be reported to the FDA. The FDA also
regulates
the product
labeling, promotion
and
,
in some cases, advertising, of medical
devices. In addition, manufacturers and their suppliers must comply with the
FDA
’
s quality system regulation which
establishes extensive requirements for quality and manufacturing procedures.
Thus, suppliers, manufacturers and distributors must continue to spend time,
money and effort to maintain compliance, and failure to comply can lead to
enforcement action. The FDA periodically inspects facilities to ascertain
compliance with these and other requirements.
Employees
On
December 31, 2007, we had 24 full-time employees. Of our full-time workforce at
that time, 12 employees were engaged in clinical trial activities and 12 were
engaged in business development, finance and administration. With the suspension
of the Company's RHEO System clinical development program, and the consequent
winding-down of the RHEO-AMD study, and the Company's disposition of SOLX, the
Company has reduced its workforce considerably. At the present time, we have 7
full-time employees. However, we continue to retain outside consultants, some of
whom are our former employees. None of our employees are covered by collective
bargaining arrangements, and our management considers its relationship with our
employees to be good.
We
continue to rely on the resources of one of our major stockholders, TLC Vision,
to provide us with infrastructure support.
Risk
Factors
Risks
Relating to Our Business
Our
financial condition and history of losses have caused our auditors to express
doubt as to whether we will be able to continue as a going concern.
We have
prepared our consolidated financial statements on the basis that we will
continue as a going concern. However, the Company has sustained substantial
losses for each of the years ended December 31, 2007, 2006 and 2005. The
Company's working capital deficiency at December 31, 2007 is $996,862, which
represents a $14,535,888 reduction in its working capital of $13,539,026 at
December 31, 2006. As a result of our history of losses and current financial
condition, there is substantial doubt about the Company's ability to continue as
a going concern.
The
Company realized gross proceeds of $10,016,000 (less transaction costs of
$871,215) on February 6, 2007 from the private placement of shares of its common
stock and warrants. Management believed that these proceeds, together with the
Company's then existing cash, would be only sufficient to cover its operating
activity and other demands until early 2008. On February 19, 2008, the Company
secured a bridge loan in an aggregate principal amount of $3,000,000 from a
number of private parties and, taking into account transactions costs of
approximately $200,000, realized net proceeds of approximately $2,800,000. The
loan bears interest at a rate of 12% per annum and has a 180-day term, which may
be extended to 270 days under certain circumstances. The repayment of the loan
is secured by a pledge by OccuLogix of its shares of the capital stock of
OcuSense. Management believes that these net proceeds, together with our
existing cash and cash-equivalents, will be sufficient to cover its operating
activities and other demands only until approximately the end of April 2008
(assuming that the outstanding obligation of OccuLogix to pay $2,000,000 to
OcuSense becomes due and payable prior to the end of April 2008).
Our
consolidated financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or the amounts and
classification of liabilities that might be necessary if the Company were not
able to continue as a going concern.
We
have incurred losses since inception and anticipate that we will incur continued
losses for the foreseeable future.
We have
incurred losses in each year since our inception in 1996. Our net loss for the
fiscal years ended December 31, 2007, 2006, 2005, 2004 and 2003 was $69.8
million, $82.2 million, $162.8 million, $21.8 million and $2.5 million,
respectively. The losses in 2007, 2006 and 2005 include a charge for impairment
of goodwill of $14.4 million, $65.9 million and $147.5 million, respectively. As
of December 31, 2007, we had an accumulated deficit of $358.3 million. These
losses, among other things, have had and will continue to have an adverse effect
on our stockholders’ equity and working capital. We remain indebted to OcuSense
in an aggregate amount of $2 million for the outstanding portion of the purchase
price of the capital stock of OcuSense that we acquired on November 30, 2006.
Currently, we anticipate that that amount will become due and payable during the
first half of 2008. Furthermore, we are legally committed to make an additional
equity investment of $3 million upon receipt, if any, from the FDA of a 510(k)
clearance for the TearLab™ test for DED and another additional equity investment
of $3 million upon receipt, if any, from the FDA of a CLIA waiver for the
TearLab™ test for DED. Because of the numerous risks and uncertainties facing
us, we are unable to predict the extent of any future losses or when we will
become profitable, if ever, or even if we will be able to continue as a going
concern.
We
may not be able to raise the capital necessary to fund our
operations.
Since
inception, we have funded our operations through early private placements of our
equity and debt securities, early stage revenues, a successful initial public
offering, or IPO, a private placement of shares of our common stock and warrants
on February 6, 2007 and, most recently, on February 19, 2008, a bridge loan.
Prior to the IPO, our cash resources were limited. We will need additional
capital in the future, and our prospects for obtaining it are uncertain. On
October 9, 2007, we announced that the Board had authorized management and our
advisors to explore the full range of strategic alternatives available to
enhance shareholder value, including, but not limited to, the raising of capital
through the sale of securities, one or more strategic alliances and the
combination, sale or merger of all or part of the Company. For some time prior
to the October 9, 2007 announcement, the Company had been seeking to raise
additional capital, with the objective of securing funding sufficient to sustain
its operations as it had been clear that, unless we were able to raise
additional capital, the Company would not have had sufficient cash to support
its operations beyond early 2008. Although the Company secured a bridge loan in
an aggregate principal amount of $3,000,000 from a number of private parties on
February 19, 2008, management believes that these net proceeds, together with
our existing cash and cash-equivalents, will be sufficient to cover its
operating activities and other demands only until approximately the end of April
2008 (assuming that the outstanding obligation of OccuLogix to pay $2,000,000 to
OcuSense becomes due and payable prior to the end of April 2008). Additional
capital may not be available on terms favorable to us, or at all. In addition,
future financings could result in significant dilution of existing stockholders.
However, unless we succeed in raising additional capital, we will be unable to
continue our operations. See “Risk Factors—Risks Relating to Our Business—Our
financial condition and history of losses have caused our auditors to express
doubt as to whether we will be able to continue as a going
concern.”
We
no longer operate any business.
With the
suspension of the Company's RHEO™ System clinical development program, and the
consequent winding-down of the RHEO-AMD study, and the Company's disposition of
SOLX, the Company no longer has any operating business. Its major asset is its
50.1% ownership stake, on a fully diluted basis, 57.62% on an issued and
outstanding basis, in OcuSense. Accordingly, unless we acquire other businesses
(which, in light of the Company's financial condition, is unlikely to occur),
our ability to generate any revenues will be dependent almost entirely upon the
success of OcuSense.
The
Company's major asset is encumbered.
The
repayment of the bridge loan, in the aggregate principal amount of $3,000,000,
which the Company secured on February 19, 2008 from a number of private parties,
is secured by a pledge by OccuLogix of its shares of the capital stock of
OcuSense. If the Company fails to repay this loan and accrued interest by the
loan’s maturity date, which will occur on the 180
th
day
following February 19, 2008 or, under certain circumstances, the 270
th
day
following February 19, 2008, the lenders may realize upon their collateral and
seize OccuLogix’s shares of the capital of OcuSense, thus causing the Company to
lose its major asset. Accordingly, the Company may lose its major asset unless
it succeeds in raising additional capital in an amount sufficient to repay the
loan and accrued interest by the loan’s maturity date—which the Company is
permitted to do through a sale of the collateral, provided that the sale
generates proceeds in an amount sufficient to repay the loan and accrued
interest if full.
The
$3,000,000 aggregate principal amount bridge loan represents a significant
dilution risk for existing stockholders.
Under the
terms of the loan agreement pursuant to which the Company secured a bridge loan,
in the aggregate principal amount of $3,000,000, on February 19, 2008 from a
number of private parties, the Company has two pre-payment options available to
it, should it decide to not wait until the maturity date to repay the loan.
Under the first pre-payment option, the Company may repay the loan in full by
paying the lenders, in cash, the amount of outstanding principal and accrued
interest and issuing to the lenders five-year warrants in an aggregate amount
equal to approximately 19.9% of the issued and outstanding shares of the
Company's common stock (but not to exceed 20% of the issued and outstanding
shares of the Company's common stock). The warrants would be exercisable into
shares of the Company's common stock at an exercise price of $0.10 per share and
would not become exercisable until the 180
th
day
following their issuance. Under the second pre-payment option, provided that the
Company has closed a private placement of shares of its common stock for
aggregate gross proceeds of at least $4,000,000, the Company may repay the loan
in full by issuing to the lenders shares of its common stock, in an aggregate
amount equal to the amount of outstanding principal and accrued interest, at a
15% discount to the price paid by the private placement investors. An exercise
by the Company of either pre-payment option will result in significant dilution
of the holdings of existing stockholders. Any exercise by the Company of the
second pre-payment option would be subject to stockholder and regulatory
approval.
OcuSense
will face challenges in bringing the TearLab™ test for DED to market and may not
succeed in executing its business plan.
At the
present time, OcuSense is relying almost entirely on OccuLogix to fund its
business. Following the payment by OccuLogix of $2,000,000 upon OcuSense’s
successful production and testing of the beta version of the TearLab™ test for
DED, there can be no assurance that OccuLogix will be a reliable source of
future funding for OcuSense, notwithstanding its agreement to purchase
$3,000,000 of shares of OcuSense’s Series B Preferred Stock upon OcuSense’s
receipt from the FDA, if any, of 510(k) clearance for the TearLab™ test for DED
and to purchase another $3,000,000 of shares of OcuSense’s Series B Preferred
Stock upon OcuSense’s receipt from the FDA, if any, of a CLIA waiver for the
TearLab™ test for DED.
There are
numerous risks and uncertainties inherent in the development of new medical
technologies. In addition to OcuSense’s eventual requirement for additional
capital, OcuSense’s ability to bring the TearLab™ test for DED to market and to
execute its business plan successfully is subject to the following risks, among
others:
|
·
|
OcuSense’s
clinical trials may not succeed. Clinical testing is expensive and can
take longer than originally anticipated. The outcomes of clinical trials
are uncertain, and failure can occur at any stage of the testing. OcuSense
could encounter unexpected problems, which could result in a delay in the
submission of its applications for the sought-after FDA approvals or
prevent their submission
altogether.
|
|
·
|
OcuSense
may not receive either the 510(k) clearance or the CLIA waiver for the
TearLab™ test for DED that it will be seeking from the FDA, in which case
OcuSense’s ability to market the TearLab™ test for DED in the United
States will be hindered severely, if not eliminated
altogether.
|
|
·
|
OcuSense
and its suppliers will be subject to numerous FDA requirements covering
the design, testing, manufacturing, quality control, labeling,
advertising, promotion and export of the TearLab™ test for DED and other
matters. If OcuSense or its suppliers fail to comply with these regulatory
requirements, the TearLab™ System could be subject to restrictions or
withdrawals from the market and OcuSense could become subject to
penalties.
|
|
·
|
Even
if it succeeds in obtaining the sought-after FDA approvals, OcuSense may
be unable to commercialize the TearLab™ test for DED successfully in the
United States. Successful commercialization will depend on a number of
factors, including, among other things, achieving widespread acceptance of
the TearLab™ test for DED among physicians, establishing adequate sales
and marketing capabilities, addressing competition effectively, the
ability to obtain and enforce patents to protect proprietary rights from
use by would-be competitors, key personnel retention and ensuring
sufficient manufacturing capacity and inventory to support
commercialization plans.
|
OcuSense’s
patents may not be valid, and OcuSense may not be able to obtain and enforce
patents to protect its proprietary rights from use by would-be competitors.
Patents of other companies could require OcuSense to stop using or pay to use
required technology.
OcuSense’s
owned and licensed patents may not be valid, and it may not be able to obtain
and enforce patents and to maintain trade secret protection for its technology.
The extent to which OcuSense is unable to do so could materially harm its
business.
OcuSense
has applied for, and intends to continue to apply for, patents relating to the
TearLab™ test for DED and related technology and processes. Such applications
may not result in the issuance of any patents, and any patents now held or that
may be issued may not provide adequate protection from competition. Furthermore,
it is possible that patents issued or licensed to OcuSense may be challenged
successfully. In that event, if OcuSense has a preferred competitive position
because of any such patents, any preferred position held by OcuSense would be
lost. If OcuSense is unable to secure or to continue to maintain a preferred
position, the TearLab™ test for DED could become subject to competition from the
sale of generic products.
Patents
issued or licensed to OcuSense may be infringed by the products or processes of
others. The cost of enforcing patent rights against infringers, if such
enforcement is required, could be significant and the time demands could
interfere with OcuSense’s normal operations. There has been substantial
litigation and other proceedings regarding patent and other intellectual
property rights in the pharmaceutical, biotechnology and medical technology
industries. OcuSense could become a party to patent litigation and other
proceedings. The cost to it of any patent litigation, even if resolved in its
favor, could be substantial. Some of OcuSense’s would-be competitors may be able
to sustain the costs of such litigation more effectively than it can because of
their substantially greater financial resources. Litigation may also absorb
significant management time.
Unpatented
trade secrets, improvements, confidential know-how and continuing technological
innovation are important to OcuSense’s future scientific and commercial success.
Although it attempts to, and will continue to attempt to, protect its
proprietary information through reliance on trade secret laws and the use of
confidentiality agreements with corporate partners, collaborators, employees and
consultants and other appropriate means, these measures may not effectively
prevent disclosure of OcuSense’s proprietary information, and, in any event,
others may develop independently, or obtain access to, the same or similar
information.
Certain
of OcuSense’s patent rights are licensed to it by third parties. If OcuSense
fails to comply with the terms of these license agreements, its rights to those
patents may be terminated, and OcuSense will be unable to conduct its
business.
It is
possible that a court may find OcuSense to be infringing upon validly issued
patents of third parties. In that event, in addition to the cost of defending
the underlying suit for infringement, OcuSense may have to pay license fees
and/or damages and may be enjoined from conducting certain activities. Obtaining
licenses under third-party patents can be costly, and such licenses may not be
available at all.
Our
common stock may be delisted from The Nasdaq Global Market.
On
September 18, 2007, OccuLogix received a letter from The Nasdaq Stock Market, or
Nasdaq, indicating that, for the previous 30 consecutive business days, the bid
price of the Company's common stock closed below the minimum $1.00 per share
requirement for continued inclusion under Marketplace Rule 4450(e)(5), or the
Minimum Bid Price Rule. Therefore, in accordance with Marketplace Rule
4450(e)(2), the Company was provided 180 calendar days, or until March 17, 2008,
to regain compliance. The Nasdaq letter stated that, if, at any time before
March 17, 2008, the bid price of the Company's common stock closes at $1.00 per
share or more for a minimum of 10 consecutive business days, Nasdaq staff will
provide written notification that it has achieved compliance with the Minimum
Bid Price Rule. The Nasdaq letter also stated that, if the Company does not
regain compliance with the Minimum Bid Price Rule by March 17, 2008, Nasdaq
staff will provide written notification that the Company's securities will be
delisted, at which time the Company may appeal the Nasdaq staff’s determination
to delist its securities to a Nasdaq Listing Qualifications Panel.
On
February 1, 2008, OccuLogix received a letter from Nasdaq indicating that, for
the previous 30 consecutive trading days, the Company's common stock did not
maintain a minimum market value of publicly held shares of $5,000,000 as
required for continued inclusion by Marketplace Rule 4450(a)(2), or the MVPHS
Rule. Therefore, in accordance with Marketplace Rule 4450(e)(1), the Company was
provided 90 calendar days, or until May 1, 2008, to regain compliance. The
Nasdaq letter stated that, if at any time before May 1, 2008, the minimum market
value of publicly held shares of the Company's common stock is $5,000,000 or
greater for a minimum of ten consecutive trading days, Nasdaq staff will provide
written notification that the Company complies with the MVPHS Rule. The Nasdaq
letter also stated that, if the Company does not regain compliance with the
MVPHS Rule by May 1, 2008, Nasdaq staff will provide written notification that
the Company's securities will be delisted, at which time the Company may appeal
the Nasdaq staff’s determination to delist its securities to a Nasdaq Listing
Qualifications Panel.
The
Company will not have become compliant with the Minimum Bid Price Rule by March
17, 2008. Although we intend to appeal any determination by Nasdaq staff to
delist our common stock to a Nasdaq Listing Qualifications Panel, we may not be
successful in our appeal, in which case our common stock may be transferred to
The Nasdaq Capital Market or be delisted altogether. Should either occur,
existing stockholders will suffer decreased liquidity.
OcuSense
and we may face future product liability claims.
The
testing, manufacturing, marketing and sale of therapeutic and diagnostic
products entail significant inherent risks of allegations of product liability.
Our past use of the RHEO™ System and the components of the SOLX Glaucoma System
in clinical trials and the commercial sale of those products may have exposed us
to potential liability claims. OcuSense’s future use of the TearLab™ test for
DED and its commercial sale could expose it to liability claims also. All of
such claims might be made directly by patients, health care providers or others
selling the products. We carry clinical trials and product liability insurance
to cover certain claims that could arise, or that could have arisen, during our
clinical trials or during the commercial use of our products. We currently
maintain clinical trials and product liability insurance with coverage limits of
$5,000,000 in the aggregate annually. Such coverage, and any coverage obtained
in the future, may be inadequate to protect OcuSense or us in the event of
successful product liability claims, and neither OcuSense nor we may be able to
increase the amount of such insurance coverage or even renew it. A successful
product liability claim could materially harm our business. In addition,
substantial, complex or extended litigation could result in the incurrence of
large expenditures and the diversion of significant resources.
For
as long as TLC Vision owns a substantial portion of our common stock, our other
stockholders may be effectively unable to affect the outcome of stockholder
voting.
TLC
Vision beneficially owns approximately 32.8%
of our outstanding
common stock, or 28.9%
on a fully diluted
basis. Accordingly, TLC Vision, in conjunction with other stockholders, could
possess an effective controlling vote on matters submitted to a vote of the
holders of our common stock.
While it
owns a substantial portion of our common stock, TLC Vision could effectively
control decisions with respect to:
|
•
|
our
business direction and policies, including the election and removal of our
directors;
|
|
•
|
mergers
or other business combinations involving
us;
|
|
•
|
the
acquisition or disposition of assets by
us;
|
|
•
|
amendments
to our certificate of incorporation and
bylaws.
|
Furthermore,
TLC Vision may be able to cause or prevent a change of control of the Company,
and this concentration of ownership may have the effect of discouraging others
from pursuing transactions involving a potential change of control of the
Company, in either case regardless of whether a premium is offered over
then-current market prices.
Conflicts
of interest may arise between us and TLC Vision, which, until December 2007, had
two directors on our board and currently has one director on our board. Our
Chief Executive Officer and Chairman served as Chairman of TLC Vision until June
2006.
TLC
Vision beneficially owns approximately 32.8% of our outstanding common stock, or
28.9% on a fully diluted basis. Our director, Richard Lindstrom, is also a
director of TLC Vision. Until June 2007 and December 2007, respectively, our
directors, Elias Vamvakas and Thomas Davidson, also served as directors of TLC
Vision.
Mr. Vamvakas beneficially
owns
1,041,795
common shares of TLC Vision,
representing approximately
2.08
% of TLC Vision
’
s outstanding shares. Mr. Davidson
beneficially owns
67,127
common shares of TLC Vision,
representing approximately
0.14
% of TLC Vision
’
s outstanding shares, and Dr. Lindstrom
beneficially owns
29,500
common shares of TLC
Vision, representing approximately
0.06
% of TLC Vision
’
s outstanding shares.
Because Dr.
Lindstrom is a director of TLC Vision, a conflict of interest could arise.
Conflicts may arise between TLC Vision and us as a result of our ongoing
agreements. We may not be able to resolve all potential conflicts with TLC
Vision, and even if we do, the resolution may be less favorable to us than if we
were dealing with an unaffiliated third party.
We
have entered into a number of related party transactions with suppliers,
creditors, stockholders, officers and other parties, each of which may have
interests which conflict with those of our public stockholders.
We have
entered into several related party transactions with our suppliers, creditors,
stockholders, officers and other parties, each of which may have interests which
conflict with those of our public stockholders.
In
December 2004, we moved from our previous headquarters which we subleased from
TLC Vision to our current headquarters, which are also in Mississauga. Until
January 31, 2006, we subleased our current headquarters from Echo Online
Internet, Inc. and, between February 1, 2006 to July 31, 2007, leased them from
Penyork Properties III Inc. Since August 1, 2007, we have been leasing them from
2600 Skymark Investments Inc., the successor in interest to Penyork Properties
III Inc. The facility presently consists of approximately 6,600 square feet of
office space utilized for management personnel. Our current arrangement expires
on July 31, 2010. Our current monthly lease obligation for rent for this
facility is approximately C$13,283. The future minimum obligation under this
lease is C$159,390 for 2008. TLC Vision has advised us that it does not have any
ownership interest in our current headquarters.
We also
leased space in a facility in Palm Harbor, Florida consisting of 5,020 square
feet of space used for warehousing the RHEO™ System components and providing
office space for certain members of our clinical trial personnel and John
Cornish, who was formerly our Vice President, Operations, and records. The
facility consisted of office and working space and an approximately 1,700 square
foot warehouse in the back. Our lease on this property expired on December 31,
2007 and has not been renewed. Our monthly lease obligation for rent for this
facility was approximately $2,168. The future minimum obligation under this
lease is therefore nil for 2008. The landlord under this lease was Cornish
Properties, which is owned by Mr. Cornish. Mr. Cornish was also one of our
directors from April 1997 to September 2004.
In
addition, OcuSense leases office space in facilities owned by parties unrelated
to us. The total future minimum obligation under these leases is $40,851 for
2008.
We
believe that if our existing facilities are not adequate to meet our business
requirements for the near-term, additional space will be available on
commercially reasonable terms.
ITEM
3.
|
LEGAL
PROCEEDINGS.
|
We are
not aware of any material litigation involving us that is outstanding,
threatened or pending.
ITEM
4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY
HOLDERS.
|
No matter
was submitted during the fourth quarter of the Company's 2007 fiscal year to a
vote of security holders, through the solicitation of proxies or
otherwise.
PART
II
ITEM
5.
|
MARKET
FOR THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS.
|
Market
for Common Equity
Our
Common Stock trades on the NASDAQ Global Market (“NASDAQ”) under the symbol
“OCCX” and the Toronto Stock Exchange (“TSX”) under the symbol
“OC”.
The
following table sets forth the range of high and low sales prices per share of
our Common Stock on both the NASDAQ and the TSX for the fiscal periods
indicated.
|
|
Common
Stock Prices
|
|
|
|
Fiscal
2007
|
|
|
Fiscal
2006
|
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
NASDAQ
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
$
|
1.98
|
|
|
$
|
1.48
|
|
|
$
|
12.85
|
|
|
$
|
3.25
|
|
Second
Quarter
|
|
|
1.68
|
|
|
|
0.76
|
|
|
|
3.70
|
|
|
|
1.86
|
|
Third
Quarter
|
|
|
1.20
|
|
|
|
0.57
|
|
|
|
2.90
|
|
|
|
1.56
|
|
Fourth
Quarter
|
|
|
0.62
|
|
|
|
0.08
|
|
|
|
2.68
|
|
|
|
1.55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TSX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
C$
|
2.35
|
|
|
C$
|
1.75
|
|
|
C$
|
14.99
|
|
|
C$
|
3.76
|
|
Second
Quarter
|
|
|
1.82
|
|
|
|
0.90
|
|
|
|
4.33
|
|
|
|
2.12
|
|
Third
Quarter
|
|
|
1.25
|
|
|
|
0.57
|
|
|
|
3.00
|
|
|
|
1.69
|
|
Fourth
Quarter
|
|
|
0.57
|
|
|
|
0.07
|
|
|
|
3.00
|
|
|
|
1.80
|
|
The
closing share price for our Common Stock on March 13, 2008 as reported by
NASDAQ, was $0.07. The closing share price for our Common Stock on March 13,
2008, as reported by TSX was C$0.08.
As of
March 13, 2008, there were approximately 92 stockholders of record of our Common
Stock.
We have
never declared or paid any cash dividends on shares of our capital stock. We
currently intend to retain all available funds to support operations and to
finance the growth and development of our business. Any determination related to
payments of future dividends will be at the discretion of our board of directors
after taking into account various factors that our board of directors deems
relevant, including our financial condition, operating results, current and
anticipated cash needs, plans for expansion and debt restrictions, if
any.
Unregistered
Issuances of Capital Stock
On February 6, 2007, we issued an
aggregate of 6,677,333 shares of Common Stock and 2,670,933 five-year stock
purchase warrants to certain institutional investors for gross cas
h
proceeds of $10,016,000 (less
transaction costs of $
871,215
). In part payment of the placement fee
payable to Cowen and Company, LLC for the services it had rendered as the
placement agent in connection with the aforementioned issuances of securities,
on February 6, 2007, we also issued 93,483 five-year stock purchase warrants to
Cowen and Company, LLC.
On
June 25, 2007, we issued an aggregate of
2,250 shares of Common Stock to Carol Jones as a result of the exercise of
options to purchase common shares at an exercise price per share of $0.99 in
consideration for cash.
Each of the above issuances was exempt
from registration under the Securities Act of 1933, as amended (the “Securities
Act”),
and Rule
506 of Regulation D promulgated thereunder
.
ITEM
6.
|
SELECTED
FINANCIAL DATA.
|
The
following tables set forth our selected historical consolidated financial data
for the years ended December 31, 2007, 2006, 2005, 2004 and 2003 which have been
derived from our consolidated financial statements included elsewhere in this
Amended Report and our consolidated financial statements included on Form S-1
for the years ended December 31, 2003. The following tables should be read in
conjunction with our financial statements, the related notes thereto and the
information contained in “Item 7 - Management’s Discussion and Analysis of
Financial Condition and Results of Operations”.
|
|
Year Ended December 31,
|
|
|
|
2003
|
|
|
2004
|
|
|
2005
(ii)
|
|
|
2006
(i)(ii)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
Restated
|
|
|
Restated
|
|
|
|
(in
thousands except per share amounts)
|
|
Consolidated
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
from related parties
|
|
$
|
390
|
|
|
$
|
732
|
|
|
$
|
81
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Revenue
from unrelated parties
|
|
|
—
|
|
|
|
238
|
|
|
|
1,759
|
|
|
|
174
|
|
|
|
92
|
|
Total
revenue
|
|
|
390
|
|
|
|
970
|
|
|
|
1,840
|
|
|
|
174
|
|
|
|
92
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold to related parties
|
|
|
373
|
|
|
|
689
|
|
|
|
43
|
|
|
|
—
|
|
|
|
—
|
|
Cost
of goods sold to unrelated parties
|
|
|
—
|
|
|
|
134
|
|
|
|
3,251
|
|
|
|
3,429
|
|
|
|
2,298
|
|
Royalty
costs
|
|
|
109
|
|
|
|
135
|
|
|
|
100
|
|
|
|
100
|
|
|
|
100
|
|
Gross
margin (loss)
|
|
|
(92
|
)
|
|
|
12
|
|
|
|
(1,554
|
)
|
|
|
(3,355
|
)
|
|
|
(2,306
|
)
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
1,565
|
|
|
|
17,530
|
|
|
|
8,670
|
|
|
|
8,476
|
|
|
|
8,104
|
|
Clinical
and regulatory
|
|
|
731
|
|
|
|
3,995
|
|
|
|
5,168
|
|
|
|
4,922
|
|
|
|
8,675
|
|
Sales
and marketing
|
|
|
—
|
|
|
|
220
|
|
|
|
2,165
|
|
|
|
1,625
|
|
|
|
1,413
|
|
Impairment
of goodwill
|
|
|
—
|
|
|
|
—
|
|
|
|
147,452
|
|
|
|
65,946
|
|
|
|
—
|
|
Impairment
of intangible asset
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20,923
|
|
Restructuring
charges
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
820
|
|
|
|
1,313
|
|
|
|
|
2,296
|
|
|
|
21,745
|
|
|
|
163,455
|
|
|
|
81,788
|
|
|
|
40,429
|
|
Other
income (expense)
|
|
|
(82
|
)
|
|
|
(110
|
)
|
|
|
1,536
|
|
|
|
1,547
|
|
|
|
2,769
|
|
Loss
from continuing operations before income taxes
|
|
|
(2,470
|
)
|
|
|
(21,843
|
)
|
|
|
(163,473
|
)
|
|
|
(83,595
|
)
|
|
|
(39,967
|
)
|
Recovery
of income taxes
|
|
|
—
|
|
|
|
24
|
|
|
|
643
|
|
|
|
2,916
|
|
|
|
5,566
|
|
Loss
from continuing operations
|
|
|
(2,470
|
)
|
|
|
(21,819
|
)
|
|
|
(162,830
|
)
|
|
|
(80,680
|
)
|
|
|
(34,401
|
)
|
Loss
from discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,542
|
)
|
|
|
(35,429
|
)
|
Net
loss for the year
|
|
$
|
(2,470
|
)
|
|
$
|
(21,819
|
)
|
|
$
|
(162,830
|
)
|
|
$
|
(82,222
|
)
|
|
$
|
(69,830
|
)
|
Per
Share Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from continuing operations per share — basic and diluted
|
|
$
|
(0.62
|
)
|
|
$
|
(2.96
|
)
|
|
$
|
(3.88
|
)
|
|
$
|
(1.79
|
)
|
|
$
|
(0.60
|
)
|
Loss
from discontinued operations per share — basic and diluted
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.04
|
)
|
|
|
(0.63
|
)
|
Net
loss per share — basic and diluted
|
|
$
|
(0.62
|
)
|
|
$
|
(2.96
|
)
|
|
$
|
(3.88
|
)
|
|
$
|
(1.83
|
)
|
|
$
|
(1.23
|
)
|
Weighted
average number of shares used in per share calculations — basic and
diluted
|
|
|
3,977
|
|
|
|
7,370
|
|
|
|
41,931
|
|
|
|
44,980
|
|
|
|
56,628
|
|
(i)
|
The
comparative figures for the year ended December 31, 2006 have been
reclassified to reflect the effect of discontinued
operations.
|
(ii)
|
The
comparative figures for the years ended December 31, 2006 and 2005 have
been corrected to reflect the Company's accounting for stock options
issued to non-employees that were subject to performance
conditions.
|
|
|
As at December 31,
|
|
|
|
|
|
|
|
2003
|
|
|
2004
|
|
|
2005
(ii)
|
|
|
2006
(i)(ii)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
Restated
|
|
|
Restated
|
|
|
|
(in
thousands)
|
|
Consolidated
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents of continuing operations
|
|
$
|
1,237
|
|
|
$
|
17,531
|
|
|
$
|
9,600
|
|
|
$
|
5,705
|
|
|
$
|
2,236
|
|
Cash
and cash equivalents of discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
36
|
|
|
|
—
|
|
Short-term
investments
|
|
|
—
|
|
|
|
42,500
|
|
|
|
31,663
|
|
|
|
9,785
|
|
|
|
—
|
|
Working
capital (deficiency) of continuing operations
|
|
|
(2,538
|
)
|
|
|
58,073
|
|
|
|
44,415
|
|
|
|
13,407
|
|
|
|
(997
|
)
|
Working capital
(deficiency) of discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
132
|
|
|
|
—
|
|
Total
assets of continuing operations
|
|
|
1,868
|
|
|
|
301,601
|
|
|
|
137,806
|
|
|
|
54,367
|
|
|
|
15,313
|
|
Total
assets of discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
44,158
|
|
|
|
—
|
|
Long-term
debt (including current portion due to stockholders)
|
|
|
3,694
|
|
|
|
517
|
|
|
|
158
|
|
|
|
152
|
|
|
|
33
|
|
Other
long-term obligations (including amount classified as current portion of
other liability)
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
6,421
|
|
|
|
—
|
|
Total
liabilities of continuing operations
|
|
|
4,134
|
|
|
|
13,502
|
|
|
|
11,765
|
|
|
|
19,673
|
|
|
|
6,358
|
|
Total
liabilities of discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
11,574
|
|
|
|
|
|
Minority
interest
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
6,111
|
|
|
|
4,954
|
|
Common
stock
|
|
|
5
|
|
|
|
42
|
|
|
|
42
|
|
|
|
51
|
|
|
|
57
|
|
Series
A Convertible Preferred Stock
|
|
|
2
|
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
Series
B Convertible Preferred Stock
|
|
|
1
|
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
|
|
―
|
|
Additional
paid-in capital
|
|
|
23,915
|
|
|
|
336,064
|
|
|
|
336,836
|
|
|
|
354,176
|
|
|
|
362,232
|
|
Accumulated
deficit
|
|
|
(26,188
|
)
|
|
|
(48,007
|
)
|
|
|
(210,837
|
)
|
|
|
(293,059
|
)
|
|
|
(358,289
|
)
|
Total
stockholders’ equity (deficiency)
|
|
|
(2,266
|
)
|
|
|
288,098
|
|
|
|
126,041
|
|
|
|
61,167
|
|
|
|
4,000
|
|
(i)
|
The
balance sheet as at December 31, 2006 has been reclassified to reflect the
assets and liabilities of discontinued
operations.
|
(ii)
|
The
comparative figures as at December 31, 2006 and 2005 have been corrected
to reflect the Company's accounting for stock options issued to
non-employees that were subject to performance
conditions.
|
ITEM
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
The
following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our restated consolidated
financial statements and related notes, included in Item 8 of this Amended
Report. Unless otherwise specified, all dollar amounts are U.S.
dollars.
Overview
We are
an ophthalmic therapeutic
company founded to commercialize innovative treatments for age-related eye
diseases. Until recently, the Company operated two business divisions, being
Retina and Glaucoma. Until recently, the Company's Retina division was in the
business of developing and commercializing a treatment for dry age-related
macular degeneration, or Dry AMD. The Company's product for Dry AMD, the RHEO™
System contains a pump that circulates blood through two filters and is used to
perform the Rheopheresis™ procedure, which is referred to under the Company's
trade name RHEO™ Therapy. The Rheopheresis™ procedure is a blood filtration
procedure that selectively removes molecules from plasma, which is designed to
treat Dry AMD, the most common form of the disease.
The
Company conducted a pivotal clinical trial, called MIRA-1, or Multicenter
Investigation of Rheopheresis for AMD, which, if successful, was expected to
support our application to the U.S. Food and Drug Administration, or FDA, to
obtain approval to market the RHEO™ System in the United States. On February 3,
2006, we announced that, based on a preliminary analysis of the data from
MIRA-1, MIRA-1 did not meet its primary efficacy endpoint as it did not
demonstrate a statistically significant difference in the mean change of Best
Spectacle-Corrected Visual Acuity applying the Early Treatment Diabetic
Retinopathy Scale, or ETDRS BCVA, between the treated and placebo groups in
MIRA-1 at 12 months post-baseline. As expected, the treated group demonstrated a
positive result. An anomalous response of the control group is the principal
reason why the primary efficacy endpoint was not met. There were subgroups that
did demonstrate statistical significance in their mean change of ETDRS
BCVA.
Subsequent
to the February 3, 2006 announcement, we completed an in-depth analysis of the
MIRA-1 study data identifying subjects that were included in the
intent-to-treat, or ITT, population but who deviated from the MIRA-1 protocol as
well as those patients who had documented losses or gains in vision for reasons
not related to retinal disease such as cataracts. Those subjects in the ITT
population who met the protocol requirements, and who did not exhibit ophthalmic
changes unrelated to retinal disease, comprised the modified per-protocol
population.
In light of the MIRA-1 study results, we
also re-evaluated our Pre-market Approval Application, or PMA, submission
strategy and then met with representatives of the FDA on June 8, 2006 in order
to discuss the impact the MIRA-1 results would have on our PMA to market the
RHEO™ System in the United States. In light of MIRA-1’s failure to
meet its primary efficacy endpoint, the FDA advised us that it will require an
additional study of the RHEO™ System to be performed.
On
January 29, 2007, the Company announced that it had obtained Investigational
Device Exemption clearance from the FDA to commence the new pivotal clinical
trial of the RHEO™ System, called RHEO-AMD, or Safety and Effectiveness in a
Multi-center, Randomized, Sham-controlled Investigation for Dry, Non-exudative
Age-Related Macular Degeneration (AMD) Using Rheopheresis.
However,
on November 1, 2007, the Company announced the indefinite suspension of its
RHEO™ System clinical development program. This decision was made following a
comprehensive review of the respective costs and development timelines
associated with the products in the Company's portfolio and in light of the
Company's financial position. Between January 29, 2007 and November 1, 2007, the
Company had prepared the RHEO-AMD protocol and had been putting into place all
of the resources required for the conduct for the RHEO-AMD study, including the
securing of clinical trial site commitments. The Company are in the process of
winding down the RHEO-AMD study as there is no reasonable prospect that the
RHEO™ System clinical development program will be relaunched in the foreseeable
future. Subsequent to our fiscal 2007 year-end, as of February 25, 2008, we have
terminated our relationship with Asahi Kasei Kuraray Medical Co., Ltd. (formerly
Asahi Kasei Medical Co., Ltd.), or Asahi Medical. Asahi Medical manufactures,
and supplied us with, the Rheofilter filter and the Plasmaflo filter, both of
which are key components of the RHEO™ System. We also are engaged in discussions
with Diamed Medizintechnik GmbH, or Diamed, and MeSys GmbH, or MeSys, regarding
the termination of our relationship with each of them. Diamed is the
designer, and MeSys is the manufacturer, of the OctoNova pump, another key
component of the RHEO™ System.
As a result of the announcement on
February 3, 2006, the per share price of our common stock as traded on the
NASDAQ Global Market, or NASDAQ, decreased from $12.75 on February 2, 2006 to
close at $4.10 on February 3, 2006. The 10-day average price of the stock
immediately following the announcement was $3.65 and reflected a decrease in our
market capitalization from $536.6 million on February 2, 2006 to $153.6 million
based on the 10-day average share price subsequent to the announcement. On June
12, 2006, we announced that the FDA will require us to perform an additional
study of the RHEO™ System. In addition, on June 30, 2006, we announced that we
had terminated negotiations with Sowood Capital Management LP (“Sowood”) in
connection with a proposed private purchase of approximately $30,000,000 of
zero-coupon convertible notes of the Company's. The per share price of our
common stock decreased subsequent to the June 12, 2006 announcement and again
after the June 30, 2006 announcement. Based on the result of the analysis of the
data from MIRA-1 and the events that occurred during the second quarter of
fiscal 2006, we concluded that there were sufficient indicators of impairment
leading to an analysis of our intangible assets and goodwill and resulting in
our reporting an impairment charge to goodwill of $65,945,686 and $147,451,758
in the second quarter of 2006 and in the fourth quarter of 2005,
respectively.
We considered the Company's announcement
of the
indefinite
suspension of
our
RHEO™ System clinical
development program for Dry AMD
to be a significant event which may
affect the carrying value of our intangible assets. This led to an analysis of
our intangible assets and resulted in our reporting an impairment charge to
intangible assets of $20,923,028 during the third quarter of 2007. We also
believe that we may not be able to sell or utilize the components of the RHEO™
System prior to their expiration dates or before the technologies become
outdated, as the case may be. Accordingly, we set up a provision for
obsolescence of $2,782,494 for treatment sets and OctoNova pumps that are
unlikely to be utilized prior to their expiration dates, in the case of
treatment sets, or before the technologies become outdated. In addition,
we
have recorded a
reduction to the carrying values of (i) certain of our medical
equipment
used in the
clinical trial
s
of the RHEO™ System
of $431,683 and (ii) certain of our
patents and trademarks related to the RHEO™ System of $190,873. No other
adjustments were made as a result of the November 1, 2007 announcement that
impacts the financial results as of December 31, 2007.
On September 29, 2004, we signed a
product purchase agreement with Veris Health Sciences Inc. (formerly RHEO
Therapeutics, Inc.), or Veris, for the purchase and sale of 8,004 treatment sets
over the period from October 2004 to December 2005, a transaction valued at
$6,003,000, after introductory rebates. However, due to delays in opening its
planned number of clinics throughout
Canada
, Veris no longer required the
contracted-for number of treatment sets in the period. We agreed to the original
pricing for the reduced number of treatment sets required in the period. In
December 2005, by letter agreement, we agreed to the volume and other terms for
the purchase and sale of treatment sets and pumps for the period ending February
28, 2006. As at December 31, 2005, the Company had received a total of
$1,779,566 from Veris. Included in amounts receivable, net as at December 31,
2005 was $1,049,297 due from Veris for the purchase of additional pumps and
treatment sets.
We believed that the announcement on
February 3, 2006 made it unlikely that we would be able to collect on amounts
outstanding from Veris as at December 31, 2005. This resulted in a provision for
bad debts of $1,049,297 during the year ended December 31, 2005, of which
$518,852 related to revenue recognized prior to December 31, 2005 and $530,445
related to goods shipped to Veris in December 2005, for which revenue was not
recognized. We also recognized an inventory loss of $252,071 during the year
ended December 31, 2005, representing the cost of goods shipped to Veris in
December 2005 which we do not anticipate will be returned by Veris.
During the year ended December 31, 2005,
w
e also fully expensed the
C$195,000 advance paid to Veris in connection with clinical trial services to be
provided by Veris for MIRA-PS, one of our clinical trials which we have
suspended. In addition, we evaluated our ending inventories as at December 31,
2005 on the basis that Veris may not be able to increase its commercial
activities in
Canada
in line with our initial expectations.
Accordingly, we set up a provision for obsolescence of $1,990,830 during the
year ended December 31, 2005 for treatment sets that will unlikely be utilized
prior to their expiration dates.
During
the year ended December 31, 2006, we sold a number of treatment sets, with a
negotiated discount, to Veris at a price lower than our cost. Accordingly, the
price which we charged to Veris, net of a negotiated discount, represents the
current net realizable value; therefore, we wrote down the value of our
treatment sets by $1,625,000 to reflect their current net realizable value as at
December 31, 2006. We also set up an additional provision for obsolescence of
$1,679,124 during the year ended December 31, 2006 for treatment sets that will
unlikely be utilized prior to their expiration dates. In addition, based on our
November 1, 2007 announcement of the indefinite suspension of our RHEO™ System
clinical development program, we wrote down the value of our pumps and clinical
inventory by $2,790,209 to reflect their current net realizable value as at
December 31, 2007.
As at December 31, 2007 and 2006, we had
combined inventory reserves of $7,295,545 and $5,101,394,
respectively.
In June 2006, Veris returned four pumps
which had been sold to it in December 2005. In fiscal 2005, we did not recognize
revenue on sales made to Veris in December 2005 and had recorded an inventory
loss associated with all sales made to Veris in December 2005. Accordingly, as
at December 31, 2006, amounts receivable and the allowance for doubtful account
recorded against the amount due from Veris have been reduced by the invoiced
amount for the four pumps of $143,520. In addition, the cost of the four pumps
returned by Veris, valued at $85,058, was used to reduce the cost of sales in
the period.
On November 6, 2006, we amended the
product purchase agreement with Veris and agreed to forgive the outstanding
amount receivable of $904,101 from Veris which had been owing for the purchase
of treatment sets and pumps and for related services delivered or provided to
Veris from September 14, 2005 to December 31, 2006. In consideration of the
forgiveness of this debt, Veris agreed that we do not owe any amounts whatsoever
in connection with (i) our use of the leasehold premises located at 5280 Solar
Drive in Mississauga, Ontario or (ii) legal fees and expenses incurred by Veris
prior to February 14, 2006 with respect to those trademarks of Veris that were
assigned to us on February 14, 2006.
In November 2006, we sold a total of 348
treatment sets to Veris for $73,776, including applicable taxes, payment for
which was not received by us within the agreed credit period. The sale of these
treatment sets was not recognized as revenue during the year ended December 31,
2006 as we believe that Veris would not be able to meet its financial
obligations to us. In January 2007, we met with the management of Veris and
agreed to forgive the outstanding amount receivable of $73,776 which was owing
for the purchase of the 348 treatment sets delivered to Veris in November
2006.
We also recognized an inventory loss of
$60,987 during the year ended December 31, 2006, representing the cost of the
348 treatment sets shipped to Veris in November 2006.
We entered into a distributorship
agreement (the “Distribution Agreement”), effective October 20, 2006, with Asahi
Medical. The Distribution Agreement replaced the 2001 distributorship agreement
between Asahi Medical and us, as supplemented and amended by the 2003, 2004 and
2005 Memoranda.
Pursuant to
the Distribut
ion
Agreement,
we
ha
d
distributorship rights to
Asahi
Medical
's Plasmaflo filter and
Asahi
Medical
's second generation polysulfone
Rheofilter
filter
on an exclusive basis in
the
United
States
,
Mexico
and certain Caribbean
countries
,
on an exclusive basis
in
Canada
,
on an exclusive basis
in
Colombia
,
Venezuela
,
New Zealand
,
Australia
and on a non-exclusive basis in
Italy
.
On
January 28, 2008, the Company disclosed that it was engaged in discussions with
Asahi Medical to terminate the Distribution Agreement. Subsequent to our 2007
fiscal year end, the Company and Asahi Medical have entered into a termination
agreement to terminate substantially all of their obligations under the
Distribution Agreement on and as of February 25, 2008 (the “Termination
Agreement”). Pursuant to the Termination Agreement, the Company and
Asahi Medical have agreed to a mutual release of claims relating to the
Distribution Agreement, other than any claims relating to certain provisions of
the Distribution Agreement which survived its termination.
In
anticipation of the delay in the commercialization of the RHEO™ System in the
United States as a result of the MIRA-1 study’s failure to meet its primary
efficacy endpoint and the FDA’s requirement of us to conduct an additional study
of the RHEO™ System, the Company accelerated our diversification plans and, on
September 1, 2006, acquired Solx, Inc., or SOLX, for a total purchase price of
$29,068,443 which included acquisition-related transaction costs of $851,279.
SOLX is a Boston University Photonics Center-incubated company that has
developed a system for the treatment of glaucoma, called the SOLX Glaucoma
System. The SOLX Glaucoma Treatment System is a next-generation treatment
platform designed to reduce intra-ocular pressure, or IOP, without a bleb, thus
avoiding its related complications. The SOLX Glaucoma System consists of the
SOLX 790 Laser, a titanium sapphire laser used in laser trabeculoplasty
procedures, and the SOLX Gold Shunt, a 24-karat gold, ultra-thin drainage device
designed to bridge the anterior chamber and the suprachoroidal space in the eye,
using the pressure differential that exists naturally in the eye in order to
reduce IOP.
On
December 20, 2007, we announced the sale of SOLX to Solx Acquisition, Inc., or
Solx Acquisition, a company wholly owned by Doug P. Adams, the founder of SOLX
and who, until the closing of the sale, had been serving as an executive officer
of the Company in the capacity of President & Founder, Glaucoma
Division. The results of operations of SOLX have been included in
discontinued operations in the Company's consolidated statements of
operations.
The
consideration for the purchase and sale of all of the issued and outstanding
shares of the capital stock of SOLX consisted of: (i) on December 19,
2007, the closing date of the sale, the assumption by Solx Acquisition of all of
the liabilities of the Company, as they related to SOLX’s business, incurred on
or after December 1, 2007, and OccuLogix’s obligation to make a $5,000,000
payment to the former stockholders of SOLX due on September 1, 2008 in
satisfaction of the outstanding balance of the purchase price of SOLX; (ii) on
or prior to February 15, 2008, the payment by Solx Acquisition of all of the
expenses that the Company had paid to the closing date, as they related to
SOLX’s business during the period commencing on December 1, 2007; (iii) during
the period commencing on the closing date and ending on the date on which SOLX
achieves a positive cash flow, the payment by Solx Acquisition of a royalty
equal to 3% of the worldwide net sales of the SOLX 790 Laser and the SOLX Gold
Shunt, including next-generation or future models or versions of these products;
and (iv) following the date on which SOLX achieves a positive cash flow, the
payment by Solx Acquisition of a royalty equal to 5% of the worldwide net sales
of these products. In order to secure the obligation of Solx Acquisition to make
these royalty payments, SOLX granted to OccuLogix a subordinated security
interest in certain of its intellectual property. In connection with the sale of
SOLX, those employees of the Company, whose roles and responsibilities related
mainly to SOLX’s business, ceased to be our employees and became employees of
Solx Acquisition or SOLX.
The sale
transaction established fair values for the Company recorded goodwill and the
Company shunt and laser technology and regulatory and other intangible assets
that had been acquired by the Company upon its acquisition of SOLX on September
1, 2006.
Accordingly, m
anagement
was required to re-assess whether
the
carrying
value of
the Company
shunt and laser technology
and regulatory and other
intangible assets
was
recoverable
as of
December 1
, 2007.
Based on management’s estimates of
undiscounted cash flows associated with these intangible assets, we concluded
that the carrying value of these intangible assets was not recoverable as of
December 1, 2007. Accordingly, we recorded an impairment charge of $22,286,383
during the year ended December 31, 2007 to record the
shunt and laser
technology and regulatory and other
intangible assets
at their fair value as of December 31,
2007
Both the
SOLX 790 Laser and the SOLX Gold Shunt are currently the subject of randomized,
multi-center clinical trials, the purposes of which are to demonstrate
equivalency to the argon laser, in the case of the SOLX 790 Laser, and to the
Ahmed Glaucoma Valve manufactured by the New World Medical, Inc., in the case of
the SOLX Gold Shunt. The results of these clinical trials will be used in
support of applications to the FDA for a 510(k) clearance for each of the SOLX
790 Laser and the SOLX Gold Shunt, the receipt of which, if any, will enable the
marketing and sale of these products in the United States.
As part
of our diversification plan, on November 30, 2006, we acquired 50.1% of the
capital stock of OcuSense, Inc., or OcuSense, measured on a fully diluted basis,
57.62% on an issued and outstanding basis, for a total purchase price of
$4,171,098 which includes acquisition-related transaction costs of $171,098. We
agreed to make additional payments totaling $4,000,000 upon the attainment of
two pre-defined milestones by OcuSense prior to May 1, 2009. In June 2007, we
paid OcuSense a total of $2,000,000 upon the attainment of the first of the two
pre-defined milestones.
OcuSense
is a San Diego-based company that is in the process of developing technologies
that will enable eye care practitioners to test, at the point-of-care, for
highly sensitive and specific biomarkers using nanoliters of tear film. The
results of OcuSense’s operations have been included in our consolidated
financial statements since November 30, 2006. OcuSense’s first product, which is
currently under development, is a hand-held tear film test for the measurement
of osmolarity, a quantitative and highly specific biomarker that has shown to
correlate with dry eye disease, or DED. The test is known as the TearLab™ test
for DED. The anticipated innovation of the TearLab™ test for DED will be its
ability to measure precisely and rapidly certain biomarkers in nanoliter volumes
of tear samples, using inexpensive hardware. Historically, eye care researchers
have relied on expensive instruments to perform tear biomarker analysis. In
addition to their cost, these conventional systems are slow, highly variable in
their measurement readings and not categorized as waived by the FDA under the
regulations promulgated under the Clinical Laboratory Improvement Amendments, or
CLIA.
The
TearLab™ test for DED will require the development of the following three
components: (1) the TearLab™ disposable, which is a single-use
microfluidic labcard; (2) the TearLab™ pen, which is a hand-held device that
interfaces with the TearLab™ disposable; and (3) the TearLab™ reader, which is a
small desktop unit that allows for the docking of the TearLab™ disposable and
the TearLab™ pen and provides a quantitative reading for the operator. OcuSense
is currently engaged in industrial, electrical and software design efforts for
the three components of the TearLab™ test for DED and, to these ends, is working
with two engineering partners, both based in Melbourne, Australia, one of which
is a leader in biomedical instrument development and the other of which is a
leader of customized microfluidics.
OcuSense’s
objective is to complete product development of the TearLab™ test for DED during
the first half of 2008. Following the completion of product development and
subsequent clinical trials, OcuSense intends to seek a 510(k) clearance and a
CLIA waiver from the FDA for the TearLab™ test for DED. Currently, it
anticipates seeking the 510(k) clearance during the latter half of 2008 and the
CLIA waiver during the latter half of 2009. In addition, OcuSense intends to
seek CE Mark approval for the TearLab™ test for DED during the latter half of
2008.
OcuSense
is a variable interest entity in accordance with FIN 46(R) and OccuLogix is the
primary beneficiary. Under FIN 46(R), assets, liabilities and non-controlling
interest shall be measured at their fair value at the time of
acquisition.
Assets
acquired and liabilities assumed consisted solely of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. Before consideration of deferred tax, the fair value of the
assets acquired was greater than the fair value of the liabilities assumed and
the non-controlling interest. Because OcuSense does not comprise a
business, as defined in EITF 98-3 “Determining Whether a Nonmonetary Transaction
Involves Receipt of Productive Assets or of a Business”, we applied
the simultaneous equation method as per EITF 98-11 “Accounting for Acquired
Temporary Differences in Certain Purchase Transactions That Are Not Accounted
for as Business Combinations”, and adjusted the assigned value of the
non-monetary assets acquired (consisting solely of the technology asset) to
include the deferred tax liability.
The fair
values of OcuSense’s assets, liabilities and minority interest, at
the date of acquisition, were as follows:
|
|
As
at November 30
|
|
|
|
2006
|
|
|
|
|
|
Net
tangible assets
|
|
$
|
2,690,316
|
|
Intangible
assets
|
|
$
|
12,895,388
|
|
Deferred_taxes
|
|
$
|
(5,158,155
|
)
|
Minority
interest
|
|
$
|
(6,256,451
|
)
|
|
|
$
|
4,171,098
|
|
On
November 30, 2006, we announced that Elias Vamvakas, our Chairman and Chief
Executive Officer, had agreed to provide us with a standby commitment to
purchase convertible debentures of Occulogix (“Convertible Debentures”) in an
aggregate maximum amount of $8,000,000 (the “Total Commitment
Amount”). Pursuant to the Summary of Terms and Conditions, executed
and delivered as of November 30, 2006 by Occulogix and Mr. Vamvakas, during the
12-month commitment term commencing on November 30, 2006, upon no less than 45
days’ written notice by the Company to Mr. Vamvakas, Mr. Vamvakas was
obligated to purchase Convertible Debentures in the aggregate principal amount
specified in such written notice. A commitment fee of 200 basis points was
payable by the Company on the undrawn portion of the total $8,000,000 commitment
amount. Any Convertible Debentures purchased by Mr. Vamvakas would have carried
an interest rate of 10% per annum and would have been convertible, at Mr.
Vamvakas’ option, into shares of our common stock at a conversion price of $2.70
per share. The Summary of Terms and Conditions of the standby commitment further
provided that if the Company closed a financing with a third party, whether by
way of debt, equity or otherwise and there are no Convertible Debentures
outstanding, then, the Total Commitment Amount was to be reduced automatically
upon the closing of the financing by the lesser of: (i) the Total Commitment
Amount; and (ii) the net proceeds of the financing. On February 6, 2007, the
Company raised gross proceeds in the amount of $10,016,000 in a private
placement of shares of its common stock and warrants. The Total Commitment
Amount was therefore reduced to zero, thus effectively terminating Mr. Vamvakas’
standby commitment. No portion of the standby commitment was ever drawn down by
the Company, and the Company paid Mr. Vamvakas a total of $29,808 in commitment
fees in February 2007.
Our results of operations for the years
ended December 31, 2007 and 2006 were impacted by our adoption of Statement of
Financial Accounting Standards (“SFAS”) No. 123R (revised 2004), “Share-Based
Payments” (“SFAS No. 123R”), on January 1, 2006 which requires us to recognize a
non-cash expense related to the fair value of our stock-based compensation
awards. We elected to use the modified prospective transition method of adoption
requiring us to include this stock-based compensation charge in our results of
operations beginning on January 1, 2006 without restating prior periods to
include stock-based compensation expense. Of the $480,971, $2,127,043 and
$224,776 stock-based compensation expense recognized during the years ended
December 31, 2007, 2006 and 2005, $65,660, $1,396,609 and $170,576 is included
in general and administrative expenses, $216,246, $203,131 and $53,700 in
clinical and regulatory expenses and $199,065, $527,303 and $500 in sales and
marketing expenses, respectively.
At the annual
meeting of stockholders of we held on
June 23, 2006, our stockholders approved the re-pricing of all then
out-of-the-money stock options of Occulogix. Consequently, the
exercise price of all outstanding stock options that, on June 23, 2006, was
greater than $2.05, being the weighted average trading price of our common stock
on NASDAQ during the five-trading day period immediately preceding June 23,
2006, was adjusted downward to $2.05. 2,585,000 of the outstanding stock options
with a weighted average exercise price of $8.42 were affected by the re-pricing.
SFAS No. 123R treats the re-pricing of equity awards as a modification of the
original award and provides that such a modification is an exchange of the
original award for a new award. SFAS No. 123R considers the
modification to be the repurchase of the old award for a new award of equal or
greater value, incurring additional compensation cost for any incremental
value. This incremental difference in value is measured as the
excess, if any, of the fair value of the modified award determined in accordance
with the provisions of SFAS No. 123R over the fair value of the original award
immediately before its terms are modified, measured based on the share price and
other pertinent factors at that date. SFAS No. 123R provides that
this incremental fair value, plus the remaining unrecognized compensation cost
from the original measurement of the fair value of the old option, must be
recognized over the remaining vesting period. Of the 2,585,000
options affected by the re-pricing, 1,401,073 were vested as at December 31,
2006.
Therefore, additional compensation cost
of $423,338 for the 1,401,073 options was recognized and is included in the
stock-based compensation expense for the year ended December 31,
2006.
In accordance with SFAS No. 123R, we
also recorded a compensation expense of $3,363 in the second quarter of fiscal
2006 as our board of directors approved accelerating the vesting of 1,250
unvested stock options granted to a terminated employee on April 28,
2006. SFAS No. 123R treats such a modification as a cancellation of
the original unvested award and the grant of a new fully vested award as of that
date.
Prior to
the adoption of SFAS No. 123R, we applied the provisions of SFAS No. 123,
“Accounting for Stock-Based Compensation” (“SFAS No. 123”), which allowed
companies either to expense the estimated fair value of employee stock options
or to follow the intrinsic value method set forth in Accounting Principles Board
Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”), but
required companies to disclose the pro forma effects on net loss as if the fair
value of the options had been expensed. We elected to apply APB No. 25 in
accounting for employee stock options. As required by SFAS No. 123, prior to the
adoption of SFAS No. 123R, we provided pro forma net loss and pro forma net loss
per share disclosures for stock-based awards as if the fair value of the options
had been expensed.
As at December 31, 2007, $3,870,931 of
total unrecognized compensation cost related to stock options is expected to be
recognized over a weighted-average period of 1.85 years.
On February 1, 2007, we entered into a
Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain
institutional investors, pursuant to which we agreed to issue to the investors
an aggregate of 6,677,333 shares of our common stock (the “Shares”) and
five-year warrants exercisable into an aggregate of 2,670,933 shares of our
common stock (the “Warrants”). The per share purchase price of the
Shares is $1.50, and the per share exercise price of the Warrants is $2.20,
subject to adjustment. The Warrants
became
exercisable on August 6, 2007. Pursuant
to the Securities Purchase Agreement, on February 6, 2007, we issued the Shares
and the Warrants. The gross proceeds of sale of the Shares
and the Warrants
totaled $10,016,000 (less transaction
costs of $
871,215
). On February 6, 2007, we also issued
to Cowen and Company, LLC a
five-year
warrant exercisable into an aggregate of
93,483 shares of our common stock (the “Cowen Warrant”) in part payment of the
placement fee payable to Cowen and Company, LLC for the services it had rendered
as the placement agent in connection with the sale of the Shares and the
Warrants. All of the terms and conditions of the Cowen Warrant (other than the
number of shares of our common stock into which
it
is exercisable) are identical to those
of the Warrants.
The estimated grant date fair value of
the Cowen Warrant of $97,222 is included in the transaction cost of
$
871,215.
We account
for
the
Warrants and the Cowen Warrant
in accordance with the
provisions of
SFAS
No. 133
,
“Accounting for Derivative Instruments
and Hedging Activities” (“SFAS No. 133”) al
ong with related
interpretation
Emerging
Issues Task Force (“EITF”)
00-19 “Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company’s Own Stock”
(“EITF 00-19”)
. SFAS No. 133 requires every derivative
instrument
within its scope
(including certain
derivative instruments embedded in other contracts) to be recorded on the
balance sheet as either an asset or liability measured at its fair value, with
changes in the derivative’s fair value recognized currently in earnings unless
specific hedge accounting criteria are met.
Based on the provisions of EITF 00-19,
we
determined that the
Warrants and the Cowen
Warrant
do not meet the criteria for
classification as equity.
Accordingly, we have classified the
Warrants and the Cowen Warrant as a current liability as of December 31,
2007.
The estimated fair value of the Warrants
and the Cowen Warrant was determined using the Black-Scholes options pricing
model. We initially allocated the total proceeds received, pursuant to the
Securities Purchase Agreement, to the Shares and the Warrants based on their
relative fair values. This resulted in an allocation of $2,052,578 to the
obligation under warrants which includes the fair value of the Cowen Warrant of
$97,222.
SFAS No. 133
also
requires
Occulogix
to record the outstanding derivatives
at fair value at the end of each reporting period resulting in an adjustment to
the recorded liability of the derivative, with any gain or loss recorded in
earnings of the applicable reporting period.
We
therefore
estimated the fair value of the
Warrants and the Cowen
Warrant as at December 31, 2007 and determined the aggregate fair
value
to be
a nominal amount, a decrease of
approximately $2,052,578 over the initial measurement of the aggregate fair
value of the Warrants and the Cowen Warrant on the date of issuance
. Accordingly,
we
recognized a
gain
of $
2,052,578
in
the Company's
consolidated statement
s
of operations for the
year ended December 31
, 2007
to
reflect the
de
crease in
our obligation to its warrant holders to
a nominal amount at December 31, 2007. Transaction costs associated with the
issuance of the Warrants of $170,081 was recorded as an expense in the Company's
consolidated statement of operations for the year ended December 31,
2007.
On March 11, 2007, our
B
oard of
D
irectors approved the grant to the
directors of the Company, other than Mr. Vamvakas, of a total of 165,000 options
under the 2002 Stock Option Plan. In exchange for these options, each of the
directors of the Company will forego the cash remuneration which he or she would
have been entitled to receive from us during the financial year end
ing
December 31, 2007 in respect of (i) his
or her annual director's fee of $15,000, (ii) in the case of those directors who
chair a committee of the board of directors of the Company, his or her fee of
$5,000 per annum for chairing such
.
committee and (iii) his or her fee of
$2,500 per fiscal quarter for the quarterly in-person meetings of the board of
directors of the Company. The number of options granted to each of the
directo
r
s
w
as
determined to be 8% higher in value
than the cash remuneration to which the directors would have been entitled
during the financial year end
ing
December 31, 2007 and
was determined using the
Black-Scholes
option
pricing model.
. The number
of options granted to each director, cal
culated using this methodology,
was then rounded up to the
nearest 1,000. These options are exercisable immediately and will remain
exercisable until the tenth anniversary of the date of their grant,
notwithstanding any earlier disability or death of the holder thereof or any
earlier termination of his or her service to the Company. The exercise price of
each option is set at
$1.82, which was the per share closing
price of
the
Company's
common stock on
NASDAQ on March 9, 2007, the last trading day prior to the date of
grant.
On May 30, 2007, TLC Vision Corporation
(“TLC Vision”) and JEGC OCC Corp. (“JEGC”) announced that JEGC had agreed to
purchase TLC Vision’s ownership stake in the Company, subject to certain minimum
prices and regulatory limitations and further subject to JEGC obtaining
satisfactory financing and other customary closing conditions. On June 22, 2007,
JEGC purchased a portion of TLC Vision’s ownership stake in the Company,
consisting of 1,904,762 shares, at a price of $1.05 per share. On July 3, 2007,
we announced that we had entered into discussions with JEGC for the private
placement of approximately $30,000,000 of shares of
our
common stock at a price based upon the
average trading price at the time of purchase, subject to compliance with
regulatory requirements and to a minimum purchase price of $1.05 per share. On
October 15, 2007, TLC Vision announced that JEGC was not able to complete the
purchase of TLC Vision’s remaining ownership stake in the Company by October 12,
2007, being the deadline previously agreed by TLC Vision and JEGC. In
making that announcement, TLC Vision also stated that JEGC retains a
non-exclusive right to purchase TLC Vision’s remaining ownership stake in the
Company, subject to the right of each of TLC Vision and JEGC to terminate the
agreement between them. It
was
anticipated that JEGC
would have
gain
ed
a control position in the Company, if
both of these transactions
had been
completed.
O
ur discussions with JEGC have not
resulted in any agreement. JEGC is owned by Jefferson EquiCorp Ltd. and by
Greybrook Corporation, a firm controlled by Mr. Vamvakas.
As at December 31, 2007, we had
investments in the aggregate principal amount of $1,900,000 which consist of
investments in four separate asset-backed auction rate securities yielding an
average return of 5.865% per annum. However, as a result of market
conditions, all of these investments have recently failed to settle on their
respective settlement dates and have been reset to be settled at a future date
with an average maturity of 46 days.
Due to
the current lack of liquidity for
asset-backed securities of this type,
we
concluded that the carrying value of
these investments was higher than its fair value as of December 31, 2007.
Accordingly, these auction rate securities have been recorded at their estimated
fair value of $
863
,750.
We
consider this to be a
n other-than-temporary
reduction in the
fair
value
of these auction rate
securities.
A
ccordingly, the loss associated with
these auction rate securities of $1,
036
,250 has been included as
an impairment of
investments in
our
consolidated statement of operations
for the year ended December 31, 2007. Although
we continue
to receive payment of interest earned
on these securities,
we
do
not know at the present
time when it will be able to convert these investments into
cash. Accordingly, management has classified these investments as a
non-current asset on its consolidated balance sheet as of December 31, 2007.
Management will continue to closely monitor these investments for future
indications of further impairment. The illiquidity of these investments may have
an adverse impact on the length of time during which
we currently expect
to be able to sustain its operations in
the absence of an additional capital raise by the Company.
On
September 18, 2007, OccuLogix received a letter from The Nasdaq Stock Market, or
Nasdaq, indicating that, for the previous 30 consecutive business days, the bid
price of the Company's common stock closed below the minimum $1.00 per share
requirement for continued inclusion under Marketplace Rule 4450(e)(5), or the
Minimum Bid Price Rule. Therefore, in accordance with Marketplace Rule
4450(e)(2), the Company were provided 180 calendar days, or until March 17,
2008, to regain compliance. The Nasdaq letter stated that, if, at any time
before March 17, 2008, the bid price of the Company's common stock closes at
$1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq
staff will provide written notification that it has achieved compliance with the
Minimum Bid Price Rule. The Nasdaq letter also stated that, if the Company do
not regain compliance with the Minimum Bid Price Rule by March 17, 2008, Nasdaq
staff will provide written notification that the Company's securities will be
delisted, at which time the Company may appeal the Nasdaq staff’s determination
to delist its securities to a Nasdaq Listing Qualifications Panel.
On
February 1, 2008, OccuLogix received a letter from Nasdaq indicating that, for
the previous 30 consecutive trading days, our common stock did not maintain a
minimum market value of publicly held shares of $5,000,000 as required for
continued inclusion by Marketplace Rule 4450(a)(2), or the MVPHS Rule.
Therefore, in accordance with Marketplace Rule 4450(e)(1), we were provided 90
calendar days, or until May 1, 2008, to regain compliance. The Nasdaq letter
stated that, if at any time before May 1, 2008, the minimum market value of
publicly held shares of the Company's common stock is $5,000,000 or greater for
a minimum of ten consecutive trading days, Nasdaq staff will provide written
notification that we comply with the MVPHS Rule. The Nasdaq letter also stated
that, if the Company does not regain compliance with the MVPHS Rule by May 1,
2008, Nasdaq staff will provide written notification that the Company's
securities will be delisted, at which time the Company may appeal the Nasdaq
staff’s determination to delist its securities to a Nasdaq Listing
Qualifications Panel.
We will
not have become compliant with the Minimum Bid Price Rule by March 17, 2008.
Although we intend to appeal any determination by Nasdaq staff to delist our
common stock to a Nasdaq Listing Qualifications Panel, we may not be successful
in our appeal, in which case our common stock may be transferred to The Nasdaq
Capital Market or be delisted altogether. Should either occur, existing
stockholders will suffer decreased liquidity.
These
Nasdaq notices have no effect on the listing of the Company's common stock on
the Toronto Stock Exchange.
Recent Development
s
On
January 9, 2008, we announced the departure, or pending departure, of seven
members of our executive team and, commencing on February 1, 2008, a 50%
reduction in the salary of each of Elias Vamvakas, our Chairman and Chief
Executive Officer, and Tom Reeves, our President and Chief Operating Officer. By
January 31, 2008, a total of 12 non-executive employees of the Company left the
Company's employment.
On
February 19, 2008, we announced that the Company had secured a bridge loan in an
aggregate principal amount of $3,000,000, less transaction costs of
approximately $200,000, from a number of private parties. The loan bears
interest at a rate of 12% per annum and has a 180-day term, which may be
extended to 270 days under certain circumstances. The repayment of the loan is
secured by a pledge by the Company of its shares of the capital stock of
OcuSense. Under the terms of the loan agreement, the Company have two
pre-payment options available to it, should it decide to not wait until the
maturity date to repay the loan. Under the first pre-payment option, the Company
may repay the loan in full by paying the lenders, in cash, the amount of
outstanding principal and accrued interest and issuing to the lenders five-year
warrants in an aggregate amount equal to approximately 19.9% of the issued and
outstanding shares of the Company's common stock (but not to exceed 20% of the
issued and outstanding shares of the Company's common stock). The warrants would
be exercisable into shares of the Company's common stock at an exercise price of
$0.10 per share and would not become exercisable until the 180
th
day
following their issuance. Under the second pre-payment option, provided that the
Company have closed a private placement of shares of its common stock for
aggregate gross proceeds of at least $4,000,000, we may repay the loan in full
by issuing to the lenders shares of its common stock, in an aggregate amount
equal to the amount of outstanding principal and accrued interest, at a 15%
discount to the price paid by the private placement investors. Any exercise by
the Company of the second pre-payment option would be subject to stockholder and
regulatory approval.
Currently,
we anticipate that the net proceeds of the loan, together with the Company's
other cash and cash equivalents, will be sufficient to sustain the Company's
operations only until approximately the end of April 2008 (assuming that the
outstanding obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due
and payable prior to the end of April 2008).
RESULTS OF
OPERATIONS
Restatement
of Consolidated Financial Statements
A.
Correction of an error related to the method of consolidation of
OcuSense Inc.
Background
Information
On
November 30, 2006, OccuLogix acquired 1,754,589 Series A preferred shares of
OcuSense Inc. (“OcuSense”). The purchase price of these shares was made up of
two fixed payments of $2.0 million each to be made on the date of the closing of
the transaction (i.e. November 30, 2006) and on January 3, 2007. In
addition, subject to OcuSense achieving certain milestones, the Company were
required to pay two additional milestone payments of $2.0 million
each.
Upon
acquiring the Series A preferred shares, OccuLogix and certain founding
stockholders entered into a voting agreement. The voting agreement
provides the founding stockholders of OcuSense, as defined in the voting
agreement, with the right to appoint two board members and OccuLogix with the
right to also appoint two directors. A selection of a fifth director
is mutually agreed upon by both OccuLogix and the founding stockholders, each
voting as a separate class. The voting agreement is subject to
termination under the following scenarios: a) a change of control; b) majority
approval of each of OccuLogix and the founding stockholders; and c) conversion
of all of the preferred shares to common shares. OccuLogix has the
ability to force the conversion of all outstanding shares of OcuSense's
Preferred stock to shares of common stock and thus has the ability to
effect a termination of the voting agreement, but this would require conversion
of its own preferred shares and the relinquishment of the rights and obligations
associated with outstanding preferred shares.
The
principal rights associated with of the Series A Preferred Stock are
as follows:
·
|
Voting
– Holders of the Series A preferred shares are entitled to vote on an
as-converted basis. Each Series A preferred share is entitled
to one vote per share.
|
·
|
Conversion
features – Series A preferred shares are convertible to common
shares on a one-for-one basis at the option of the
holder.
|
·
|
Dividends
– The preferred shares are entitled to non-cumulative dividends at 8%, and
additional dividends would be shared between common and preferred shares
on a per-share basis.
|
·
|
Redemption
features – Subsequent to November 30, 2011, the preferred shares may be
redeemed, at the option of the holder, at the higher of the
original issue price and the fair market value of the common shares into
which the preferred shares could be converted, subject to available
cash.
|
·
|
Liquidation
preferences – Series A preferred shares have a liquidation preference over
OcuSense's common shares up to the original issue price of the preferred
shares (including the milestone
payments).
|
Immediately
after the OccuLogix investment in OcuSense, OcuSense had the following capital
structure:
Description
|
|
Number
|
|
Common
shares
|
|
|
1,222,979
|
|
Series
A preferred shares – OccuLogix
|
|
|
1,754,589
|
|
Series
A preferred shares – Other unrelated parties
|
|
|
67,317
|
|
Total
|
|
|
3,044,885
|
|
|
|
|
|
|
Potentially
dilutive instruments
|
|
|
|
|
Warrants
|
|
|
89,965
|
|
Stock
Options
|
|
|
367,311
|
|
Fully
Diluted
|
|
|
3,502,161
|
|
Based on
the above capital structure, on a fully diluted basis, OccuLogix’s voting
percentage was determined to be 50.1%. On a current
voting basis, OccuLogix’s voting interest is 57.62%. We previously consolidated
OcuSense based on an ownership percentage of 50.1%.
Interpretation and Related
Accounting Treatment
Since
November 30, 2006, the date of the acquisition, we have consolidated OcuSense on
the basis of a voting control model, as a result of the fact that we own more
than 50% of the voting stock of OcuSense and that we had the ability to convert
our Series A preferred shares into common shares, which would result in the
termination of the voting agreement between the founders and OccuLogix and which
would result in our gaining control of the board of directors.
However,
after further consideration the Company has now determined that, as a result of
the voting agreement between us and the founding stockholders of OcuSense, we
are not able to exercise voting control as contemplated in ARB 51 “Consolidated
Financial Statements” (“ARB 51”) unless the Company converts its Series A
preferred shares of OcuSense. For purposes of assessing voting
control in accordance with ARB 51, US GAAP does not take into consideration such
conversion rights. Accordingly we do not have the ability to exercise control of
OcuSense in light of the voting agreement that currently exists between the
founding shareholders and us.
In
addition to the above consideration, we also determined that OcuSense is a
Variable Interest Entity and that we are the primary beneficiary based on the
following:
·
|
OcuSense
is a development stage enterprise (as defined under FAS 7, “Accounting and
Reporting by Development Stage Enterprises”) and therefore is not
considered to be a business under U.S. GAAP. Accordingly,
OcuSense is not subject to the business scope
exception.
|
·
|
We
noted that the holders of the Series A preferred shares (including us)
have the ability to redeem their shares at the greater of their original
subscription price and their fair value on an as-converted
basis. As such, their investment is not considered to be
at-risk equity.
|
·
|
Additionally,
as a result of the voting agreement between us and the founding
shareholders of OcuSense, voting control of OcuSense is shared between us
and OcuSense. Accordingly, the common shareholders, who
represent the sole class of at-risk equity, cannot make decisions about an
entity’s activities that have a significant effect on the success of the
entity without our concurrence.
|
FIN 46(R)
requires that the enterprise which consolidates the variable interest entity be
the primary beneficiary of that entity. The primary beneficiary is the entity
that will absorb a majority of the variable interest entity’s expected losses,
receive a majority of the entity’s expected returns, or both. Since the date of
acquisition of the Shares, the purchase price therefore (including the two
additional milestone payments) has constituted virtually the entire source of
funding of OcuSense. The common shareholders were expected to make
nominal equity contributions during this period. Therefore, based
primarily on qualitative considerations, we believe that we are the primary
beneficiary of OcuSense and should consolidate OcuSense using the variable
interest model.
The
Company have noted that the initial measurement of assets, liabilities and
non-controlling interests under FIN 46(R) differs from that which is required
under FAS 141 “Business Combinations”. In particular, under FIN
46(R), assets, liabilities and non-controlling interest shall be measured
initially at their fair value. The Company previously recorded the
non-controlling interest based on the historical carrying values of OcuSense’s
assets and liabilities and, as a result, consolidation under FIN 46(R) has
resulted in material revisions to the amounts previously reported
in the consolidated financial statements.
Assets
acquired and liabilities assumed consisted primarily of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. Before consideration of deferred tax, the fair value of the
assets acquired will be greater than the fair value of the liabilities assumed
and the non-controlling interest. Because OcuSense does not comprise
a business, as defined in EITF 98-3 “Determining Whether a Nonmonetary
Transaction Involves Receipt of Productive Assets or of a Business”, the
Company applied the simultaneous equation method as per EITF 98-11
“Accounting for Acquired Temporary Differences in Certain Purchase Transactions
That Are Not Accounted for as Business Combinations”, and adjusted the assigned
value of the non-monetary assets acquired (consisting solely of the technology
asset) to include the deferred tax liability.
The
Company also considered the appropriate accounting for the milestone
payments, as a result of the fact that it has determined that it should apply
the initial measurement guidance in FIN 46(R). The Company note
that subsequent to initial consolidation, the milestone payment liability
represents a contingent liability to a controlled subsidiary, and as such, the
liability eliminates on consolidation. Previously, the Company
adjusted the minority interest at the date of each milestone payment to reflect
the non-controlling interest’s share in the additional cash of the subsidiary,
with an offsetting increase to the non-monetary assets acquired (consisting
solely of the technology intangible asset) reflecting the increased actual cost
of obtaining those non-monetary assets.
The
Company note that because the non-controlling interest is required to be
measured at fair value on acquisition of OcuSense, the fair value of the
milestone payments as of the date of acquisition will be embedded in the initial
measurement of non-controlling interest. As such, it would be
inappropriate to record additional minority interest based on the full amount of
the milestone payment applicable to the minority
interest. Accordingly, the Company have accounted for the milestone
payments as follows:
|
·
|
We
determined the fair value of the milestone payments on the date of
acquisition, by incorporating the probability that the milestone payments
will be made, as well as the time value associated with the planned
settlement date of the payments.
|
|
·
|
Upon
payment of the milestone payments, we recorded the minority interest
portion of the change in fair value of the milestone payment (i.e. the
minority interest portion of the ultimate value of the milestone payment
less the initial fair value determination) as an expense, with a
corresponding increase to minority interest, to reflect the additional
value provided to the minority interest in excess of that contemplated on
the acquisition date.
|
The
following is a summary of the significant effects of the restatements on our
consolidated balance sheets as of December 31, 2007 and 2006 and its
consolidated statements of operations and cash flows for the fiscal years ended
December 31, 2007 and 2006.
|
|
December
31, 2007
|
|
|
December
31, 2006
|
|
|
|
As
previously reported (1)
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
As
previously reported (1)
|
|
|
Adjustment
|
|
|
As
restated
|
|
Consolidated
Balance Sheet Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible
Assets
|
|
|
5,770,677
|
|
|
|
5,314,377
|
|
|
|
11,085,054
|
|
|
|
26,876,732
|
|
|
|
8,121,723
|
|
|
|
34,998,455
|
|
Deferred
Tax
|
|
|
—
|
|
|
|
2,259,348
|
|
|
|
2,259,348
|
|
|
|
7,851,667
|
|
|
|
3,248,689
|
|
|
|
11,100,356
|
|
Minority
Interest
|
|
|
—
|
|
|
|
4,593,960
|
|
|
|
4,593,960
|
|
|
|
1,184,844
|
|
|
|
4,925,990
|
|
|
|
6,110,834
|
|
Additional
paid-in capital
|
|
|
362,402,899
|
|
|
|
(170,868
|
)
|
|
|
362,232,031
|
|
|
|
354,191,066
|
|
|
|
(15,562
|
)
|
|
|
354,175,504
|
|
Accumulated
deficit
|
|
|
(356,560,917
|
)
|
|
|
(1,728,063
|
)
|
|
|
(356,288,980
|
)
|
|
|
(293,021,603
|
)
|
|
|
(37,394
|
)
|
|
|
(293,058,997
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statement of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
7,373,726
|
|
|
|
730,679
|
|
|
|
8,104,405
|
|
|
|
8,407,501
|
|
|
|
68,250
|
|
|
|
8,475,751
|
|
Minority
interest
|
|
|
2,182,843
|
|
|
|
(870,665
|
)
|
|
|
1,312,178
|
|
|
|
157,624
|
|
|
|
3,555
|
|
|
|
161,179
|
|
Recovery
of Income taxes
|
|
|
5,654,868
|
|
|
|
(89,326
|
)
|
|
|
5,565,542
|
|
|
|
2,888,490
|
|
|
|
27,300
|
|
|
|
2,915,790
|
|
Loss
from continuing operations
|
|
|
(32,710,416
|
)
|
|
|
(1,690,669
|
)
|
|
|
(34,401,085
|
)
|
|
|
(80,642,119
|
)
|
|
|
(37,394
|
)
|
|
|
(80,679,513
|
)
|
Net
loss for the year
|
|
|
(68,139,314
|
)
|
|
|
(1,690,669
|
)
|
|
|
(69,829,983
|
)
|
|
|
(82,184,503
|
)
|
|
|
(37,394
|
)
|
|
|
(82,221,897
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statement of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year
|
|
|
(68,139,314
|
)
|
|
|
(1,690,669
|
)
|
|
|
(69,829,983
|
)
|
|
|
(82,184,503
|
)
|
|
|
(37,394
|
)
|
|
|
(82,221,897
|
)
|
Amortization
of Intangibles
|
|
|
4,578,027
|
|
|
|
730,679
|
|
|
|
5,308,706
|
|
|
|
2,749,212
|
|
|
|
68,250
|
|
|
|
2,817,462
|
|
Deferred
income taxes
|
|
|
(15,004,750
|
)
|
|
|
89,325
|
|
|
|
(14,915,425
|
)
|
|
|
(4,065,962
|
)
|
|
|
(27,300
|
)
|
|
|
(4,093,262
|
)
|
Minority
interest
|
|
|
(2,182,843
|
)
|
|
|
870,665
|
|
|
|
1,312,178
|
|
|
|
(157,624
|
)
|
|
|
(3,555
|
)
|
|
|
(161,179
|
)
|
(1)
Amounts reflect correction
of prior year’s amounts related to stock options granted to consultants as noted
below.
B.
|
Correction
of prior years’ comparative amounts
|
In
accordance with the Securities and Exchange Commission (the “SEC”) Staff
Accounting Bulletin (“SAB”) No. 108, “Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial
Statements”, the following discussion on the Company's results of operations
have been corrected to reflect the Company's accounting for stock options
granted during fiscal 2005 to certain consultants that were subject to
performance conditions. The vesting of these options was contingent
upon the attainment of FDA approval of the RHEO™ System. These stock
options were accounted for in accordance with SFAS No. 123 and subsequently in
accordance with SFAS No. 123(R) upon the Company's adoption of SFAS No. 123(R)
on January 1, 2006. The total fair value of these options was estimated at the
date of grant and was being amortized, over the Company's estimate of the
expected vesting period, as stock-based compensation expense in our consolidated
statements of operations. In preparing the financial statements for
the year ended December 31, 2007, the Company noted that these options should
have been accounted for in accordance with EITF 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services, (“EITF 96-18”) which requires that
if, on the measurement date of the award, the quantity or any of the terms of
the equity instruments are dependent on the achievement of performance
conditions which result in a range of fair values, the lowest aggregate amount
should be used.
Based on
the provisions of EITF 96-18, the Company concluded that no stock-based
compensation expense should have been recorded for these options. Since the
effect of the error on the individual prior periods’ consolidated financial
statements was immaterial, the Company have adjusted the comparative
consolidated financial statements of prior years to reflect the correction of
this error without undertaking a restatement of the prior periods’ consolidated
financial statements. The following financial statement line items for fiscal
2006 and 2005 were affected by the correction of the error.
|
|
Previously
reported (i)
|
|
|
Corrected
amount (i)
|
|
|
Effect
of error
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
Balance
Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
354,320,116
|
|
|
|
354,191,066
|
|
|
|
(129,050
|
)
|
Accumulated
deficit
|
|
|
(293,150,653
|
)
|
|
|
(293,021,603
|
)
|
|
|
129,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
336,977,578
|
|
|
|
336,835,573
|
|
|
|
(142,005
|
)
|
Accumulated
deficit
|
|
|
(210,979,105
|
)
|
|
|
(210,837,100
|
)
|
|
|
142,005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements
of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
(ii)
|
|
|
8,452,915
|
|
|
|
8,407,501
|
|
|
|
45,414
|
|
Clinical
and regulatory
(ii)
|
|
|
4,956,207
|
|
|
|
4,921,771
|
|
|
|
34,436
|
|
Sales
and marketing
(ii)
|
|
|
1,639,428
|
|
|
|
1,625,188
|
|
|
|
14,240
|
|
Loss
from continuing operations
|
|
|
(80,736,209
|
)
|
|
|
(80,642,119
|
)
|
|
|
94,090
|
|
Cumulative
effect of a change in accounting principle
|
|
|
107,045
|
|
|
|
—
|
|
|
|
(107,045
|
)
|
Net
loss for the year
|
|
|
(82,171,548
|
)
|
|
|
(82,184,503
|
)
|
|
|
(12,955
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative expenses
|
|
|
8,729,456
|
|
|
|
8,670,394
|
|
|
|
59,062
|
|
Clinical
and regulatory expenses
|
|
|
5,250,492
|
|
|
|
5,167,549
|
|
|
|
82,943
|
|
Loss
from continuing operations
|
|
|
(162,971,986
|
)
|
|
|
(162,829,981
|
)
|
|
|
142,005
|
|
Net
loss for the year
|
|
|
(162,971,986
|
)
|
|
|
(162,829,981
|
)
|
|
|
142,005
|
|
|
|
Previously
reported
|
|
|
Corrected
amount
|
|
|
Effect
of error
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements
of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to cash used in operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
(ii)
|
|
|
2,221,133
|
|
|
|
2,127,043
|
|
|
|
94,090
|
|
Cumulative
effect of a change in accounting principle
|
|
|
(107,045
|
)
|
|
|
—
|
|
|
|
(107,045
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to cash used in operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
366,781
|
|
|
|
224,776
|
|
|
|
142,005
|
|
(i)
These amounts do not reflect any adjustments related to the accounting for our
investment in OcuSense, as previously discussed.
(ii)
The
comparative figures for the year ended December 31, 2006 have been reclassified
to reflect the effect of discontinued operations.
The
cumulative effect of the correction for the years ended December 31, 2006 and
2005 on basic and diluted net loss per share was nil.
Continuing
Operations
Revenues, Cost of
Goods Sold
and Gross Margin
For the years ended December
31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
Change
|
|
|
200
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales to related
parties
|
|
$
|
—
|
|
|
|
N/M
|
*
|
|
$
|
—
|
|
|
|
N/M
|
*
|
|
$
|
81
|
|
Sales to unrelated
parties
|
|
|
92
|
|
|
|
(47
|
)%
|
|
|
174
|
|
|
|
(90
|
)%
|
|
|
1,759
|
|
Total
revenues
|
|
$
|
92
|
|
|
|
(47
|
)
%
|
|
$
|
174
|
|
|
|
(91
|
)
%
|
|
$
|
1,840
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold to related
parties
|
|
$
|
—
|
|
|
|
N/M
|
*
|
|
$
|
—
|
|
|
|
N/M
|
*
|
|
$
|
43
|
|
Cost of goods sold to unrelated
parties
|
|
|
2,298
|
|
|
|
(33
|
)%
|
|
|
3,429
|
|
|
|
5
|
%
|
|
|
3,251
|
|
Royalty
costs
|
|
|
100
|
|
|
|
—
|
|
|
|
100
|
|
|
|
—
|
|
|
|
100
|
|
Total cost of
goods sold
|
|
$
|
2,398
|
|
|
|
(32
|
)
%
|
|
$
|
3,529
|
|
|
|
4
|
%
|
|
$
|
3,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
G
ross
loss
|
|
|
(
2,306
|
)
|
|
|
31
|
%
|
|
|
(
3,355
|
)
|
|
|
(
116
|
)%
|
|
|
(1,554
|
)
|
Percentage of total
revenue
|
|
|
(
2,507
|
)%
|
|
(579)
pts
|
|
|
|
(
1,928
|
)%
|
|
(
1,844
) pts
|
|
|
|
(84
|
)
%
|
*N/M – Not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
Revenue consists of revenue generated
from the sale of components of the RHEO™ System which consists of the OctoNova
pump and the disposable treatment sets, which include two disposable filters and
applicable tubing.
During the
year ended December 31, 2007
, we sold a total of
816
treatment sets, at a price of $200 per
treatment set, to Veris. The sale of these treatment sets was not recognized as
revenue during the
year
based on Veris’ payment h
istory with us and the
180-day payment terms agreed by Veris
and us in March 2007. In October 2007, we met with the management of Veris and
based on discussions with Veris, we believe that Veris will not be able to meet
its financial obligations to
us
. Therefore, during the
year
ended
December 31
, 2007,
the Company
recorded an allowance for doubtful
accounts against the total amount due from Veris for the purchase of the
treatment sets.
Revenues for the year ended December
31
, 2007
is made up of revenue from the sale
of
a total of 600 treatment
sets at a negotiated price of $150 per treatment set to Macumed AG, a company
based in
Germany
.
Revenues for the year ended December 31,
2006 include the sale of 859 treatment sets to Veris at a negotiated price of
$200 per treatment set as payment was received by us in advance of shipment of
the treatment sets.
During fiscal 2006, as compared with
fiscal 2005, revenues decreased significantly primarily due to reduced sales of
components of the RHEO™ System to Veris as a result of our February 3, 2006
announcement that MIRA-1 did not meet its primary efficacy endpoint. In
addition, included in revenues in fiscal 2005 are sales made to RHEO Clinic
Inc., a subsidiary of TLC Vision Corporation (“TLC Vision”) and a related party,
for which we reported revenues of $81,593 in the period. RHEO Clinic Inc. has
since ceased the treatment of commercial patients and is therefore no longer a
source of revenue for us.
On
November 1, 2007, we announced an indefinite suspension of the RHEO™ System
clinical development program for Dry AMD and are in the process of winding down
the RHEO-AMD study. Accordingly, we do not expect to be able to continue to
generate revenue from the sale of the components of the RHEO™ System in the
future.
Cost of Sales
Cost of
sales includes costs of goods sold and royalty costs. Our cost of goods sold
consists primarily of costs for the manufacture of the RHEO™ System, including
the costs we incur for the purchase of component parts from our suppliers,
applicable freight and shipping costs, fees related to warehousing, logistics
inventory management and recurring regulatory costs associated with conducting
business and ISO certification.
During
fiscal 2006, we sold a number of treatment sets to Veris at a price, net of
negotiated discounts, which was lower than our cost. As Veris was then our sole
customer for the RHEO™ System treatment sets, the price at which we sold the
treatment sets to Veris represented our inventory’s then current net realizable
value, and therefore, we have written down the value of the treatment sets to
reflect this net realizable value. Included in cost of sales for the year ended
December 31, 2006, is $1,625,000 which reflects the write-down of the treatment
sets to its net realizable value. In addition, we evaluated our ending
inventories as at December 31, 2006 on the basis that Veris may not be able to
increase its commercial activities in Canada in line with our initial
expectations. Accordingly, we set up an additional provision for obsolescence of
$1,679,124 during the year ended December 31, 2006 for treatment sets that will
unlikely be utilized prior to their expiration dates (2005 - $1,990,830). As at
December 31, 2006, the value of our commercial inventory of treatment sets was
nil. On November 1, 2007, we announced an indefinite suspension of the RHEO™
System clinical development program for Dry AMD, and we are engaged in the
process of winding down
the RHEO-AMD study.
Accordingly,
we have written down the value of our commercial inventory of OctoNova pumps to
nil as of December 31, 2007 since the Company may not be able to sell or utilize
these pumps before their technologies become outdated. Included in cost of sales
for the year ended December 31, 2007, is a charge of $2,190,666 which reflects
the write-down of the value of these pumps to nil as of December 31,
2007.
Cost of
sales for the year ended December 31, 2007 includes royalty fees payable to Dr.
Brunner and Mr. Stock and a charge of $2,190,666 which reflects the write-down
of the value of our commercial inventory of pumps to nil as of December 31,
2007. Included in cost of sales for the year ended December 31, 2006 are royalty
fees payable to Dr. Brunner and Mr. Stock and a total charge of $3,304,124 which
reflect the write-down of our commercial inventory of treatment sets to nil as
at December 31, 2006.
During the year ended December 31, 2006,
as compared with the corresponding period in fiscal 2005, cost of sales
increased due primarily to the charge of $1,625,000 which reflects the
write-down of our inventory of treatment sets to its net realizable value. There
was no comparative expense in fiscal 2005. Cost of sales for the years ended
December 31, 2006 and 2005 includes a provision for obsolescence of $1,679,124
and 1,990,830, respectively, for treatment sets that will unlikely be utilized
prior to their expiration dates.
Gross Margin
During
fiscal 2007 as compared with fiscal 2006, our retina gross margin decreased 579
percentage points due to reduced sales in fiscal 2007.
During
fiscal 2006 as compared with fiscal 2005, our retina gross margin decreased
1,844 percentage points due to reduced sales in fiscal 2006 and increased cost
of sales due to the inventory write-down and the provision for obsolescence
recorded in the period.
Operating Expenses
For the years ended December
31,
(in thousands)
|
|
2007
|
|
|
Change
|
|
|
2006
|
|
|
Change
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
$
|
8,104
|
|
|
|
(4
|
)%
|
|
$
|
8,476
|
|
|
|
(2
|
)%
|
|
$
|
8,670
|
|
Clinical and
regulatory
|
|
|
8,
676
|
|
|
|
76
|
%
|
|
|
4,922
|
|
|
|
(5
|
)%
|
|
|
5,168
|
|
Sales and
marketing
|
|
|
1,413
|
|
|
|
(13
|
)%
|
|
|
1,625
|
|
|
|
(25
|
)%
|
|
|
2,165
|
|
Impairment of
goodwill
|
|
|
—
|
|
|
|
(100
|
)%
|
|
|
65,946
|
|
|
|
(55
|
)%
|
|
|
147,452
|
|
Impairment of intangible
asset
|
|
|
20,923
|
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Restructuring
charges
|
|
|
1,313
|
|
|
|
60
|
%
|
|
|
820
|
|
|
|
N/M
|
*
|
|
|
—
|
|
Total operating
expenses
|
|
$
|
40,429
|
|
|
|
(51
|
)%
|
|
$
|
81,788
|
|
|
|
(50
|
)%
|
|
$
|
163,455
|
|
*N/M – Not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and Administrative
Expenses
General and administrative expenses
decreased by $371,346 during the year ended December 31, 2007, as compared with
the corresponding period of fiscal 2006
due to a decrease of $1,352,416 in
stock-based compensation expense which reflects the reversal of the stock-based
compensation expense recorded in prior periods associated with performance-based
options granted to certain of our employees, directors and consultants. The
vesting of these options was contingent upon meeting company-wide goals which
include the attainment of FDA approval of the RHEO™ System and the achievement
of a minimum amount of sales over a specified period. In light of the indefinite
suspension of the RHEO™ System clinical development program and the sale of
SOLX, management concluded that these goals were no longer achievable and
accordingly has reversed the option expense recorded in prior periods associated
with these performance-based options.
Included
within general and administrative expense are professional fees which decreased
by $352,634 during the year ended December 31, 2007 as compared with the
corresponding period of fiscal 2006. These decreases were partially offset by
the increase in employee and related travel costs of $383,859 due to the
additional cost of OcuSense employees during the period as well as the increase
in amortization expense of $1,182,077 associated with the intangible asset
acquired upon the acquisition of OcuSense on November 30, 2006. General and
administrative expenses for the year ended December 31, 2007 also include a
charge of $190,873 which reflects the reduction to the carrying value of certain
of our patents and trademarks related to the RHEO™ System as a result of our
indefinite suspension of the RHEO™ System clinical development program for Dry
AMD. There was no comparative charge during the year ended December 31,
2006. The above decreases were partially offset by a net increase in
amortization expense related to intangible assets by $730,679. As
previously discussed, the increase in amortization expense is attributed to a
higher intangible asset value arising from the fair value adjustments associated
with consolidating OcuSense as a variable interest entity on the date of
acquisition.
General
and administrative expenses decreased by $194,643 during the year ended December
31, 2006, as compared with the corresponding period of fiscal 2005. This
decrease is due to the decrease in employee and related travel costs of $537,274
due in part to the grant of options to an employee in lieu of salary.
Professional fees and fees associated with compliance with Section 404 of the
Sarbanes-Oxley Act of 2002 also decreased by $917,318 while directors’ fees
decreased by $50,207 due to the grant of options to directors in lieu of their
annual fees payable for board and committee memberships. These decreases in cost
were partially offset by an increase of $1,262,292 in stock-based compensation
expense associated with the adoption of SFAS No. 123R on January 1, 2006 which
requires us to recognize a non-cash expense related to the fair value of our
stock-based compensation awards. In addition, included within general
and administrative expense for the year ended December 31, 2006 is $68,250 in
additional amortization expense related to the accounting for OcuSense as a
variable interest entity since the date of acquisition on November 30,
2006. There was no similar amounts in prior periods.
We are continuing to focus our efforts
on achieving additional operating
efficiencies by reviewing and improving
upon our existing business processes and cost structure..
Clinical and Regulatory
Expenses
Clinical
and regulatory expenses increased by $3,753,781 during the year ended December
31, 2007, as compared with the corresponding prior year period, due to the
increase in OcuSense product development and regulatory costs of $2,564,703.
OcuSense employee and related travel costs, professional fees and options
expense also increased by $494,458, $328,713 and $112,360, respectively, during
the year ended December 31, 2007 as compared with the corresponding period in
fiscal 2006. We acquired 50.1% of the capital stock, on a fully diluted basis,
57.62% on an issued and outstanding basis, of OcuSense on November 30, 2006.
Therefore, clinical and regulatory expenses for the year ended December 31, 2006
include OcuSense’s cost for the month of December 2006. Clinical trial expenses
associated with the RHEO-AMD trial also increased by $1,101,074. The RHEO-AMD
trial was abandoned on November 1, 2007. Accordingly, we have recorded a
write-down to the value of our inventory of treatment sets used for the trial
and also written down the carrying value of certain of our medical equipment
used in the trial. Clinical and regulatory expenses for the year ended December
31, 2007 therefore include a charge of $942,309 which reflects the write-down of
our inventory and certain of our medical equipment as of December 31, 2007. Also
included in clinical trial expenses for the year ended December 31, 2006 are
advance payments totaling $243,644 made to various clinical trial sites for the
provision of clinical trial services in connection with our RHEO-AMD trial which
we have abandoned. This unrecoverable amount has been fully expensed in the year
ended December 31, 2007. There was no comparative expense during the year ended
December 31, 2006. These increases in cost during the year ended December 31,
2007 were offset in part by the decrease in costs associated with the MIRA-1
trial, the LEARN, or Long-term Efficacy in AMD from Rheopheresis in North
America, trials and other related clinical trials of $2,200,131 since the
Company completed the analysis of the MIRA-1 data during the first half of
fiscal 2006 and the treatment phase of the LEARN trials was completed in
December 2006.
During
the year ended December 31, 2006, clinical and regulatory expenses decreased by
$245,778, as compared with the corresponding period in fiscal 2005, as a result
of decreased professional fees associated with the MIRA-1 clinical trial of
$233,920.
Our goal is to complete product
development of OcuSense’s TearLab™ test for DED. Following the completion of
product development, OcuSense will have to conduct clinical trials in order to
seek a 510(k) clearance and a CLIA waiver from the FDA for the TearLab™ test for
DED.
Sales and Marketing
Expenses
Sales and
marketing expenses decreased by $211,729 during the year ended December 31,
2007, as compared with the prior period in fiscal 2006, due to the decrease in
the RHEO™ System marketing expenses of $128,420. Stock-based compensation
expense also decreased by $331,038 which reflects the reversal of the
stock-based compensation expense recorded in prior periods associated with
performance-based options granted to certain of our employees, directors and
consultants. The vesting of these options was contingent upon meeting
company-wide goals which include the attainment of FDA approval of the RHEO™
System and the achievement of a minimum amount of sales over a specified period.
In light of the indefinite suspension of the RHEO™ System clinical development
program and the sale of SOLX, management concluded that these goals were no
longer achievable and accordingly has reversed the option expense recorded in
prior periods associated with these performance-based options. These decreases
in cost were offset in part by the increase in OcuSense employee and related
travel costs of $146,504 and professional fees of $61,559. During 2007, OcuSense
hired a new employee and retained the use of some outside consultants to begin
establishing sales and marketing efforts to increase awareness of the TearLab™
test for DED, and upon receipt of FDA approval, to promote the use of the
TearLab™ test for DED in the United States.
Sales and
marketing expenses decreased by $540,149 during the year ended December 31,
2006, as compared with the prior period in fiscal 2005, due to reduced employee
and travel costs during the period of $422,423 and a decrease in marketing
expenses of $344,067 due to reduced marketing efforts in the year following the
announcement of MIRA-1 results. Bad debt expense also decreased during the year
ended December 31, 2006 by $510,913 as we only recognized revenue on sale of
treatment sets sold to its then sole customer, Veris, on receipt of payment.
These decreases in costs were offset by increased stock-based compensation
expense of $524,003 associated with the adoption of SFAS No. 123R beginning
January 1, 2006 and increased fees and expenses of our Scientific Advisory Board
members of $210,456.
The cornerstone of our sales and
marketing strategy to date has been to increase awareness of our product among
eye care professionals and, in particular, the key opinion leaders in the eye
care professions. OcuSense will continue to develop and execute our conference
and podium strategy to ensure visibility and evidence-based positioning of the
TearLab™ test for DED among eye care professionals.
Impairment of
Goodwill
The decrease in our stock price
subsequent to the February 3, 2006 announcement of
the
MIRA-1
trial
's failure to meet its
primary
efficacy
endpoint
, the June 12, 2006
announcement of the outcome of our meeting with the FDA and the June 30, 2006
announcement of the termination of negotiations with Sowood
w
ere
identified as indicator
s
of impairment which led to an analysis
of our intangible assets and goodwill
which, in turn,
result
ed
in the reporting of an impairment
charge of $65,946,686
and
$147,451,758
during the years ended December 31, 2006
and 2005
,
respectively
. The
impairment of goodwill charge represents the write
-
down of the value of goodwill acquired
on the purchase of TLC Vision's 50% interest in OccuLogix, L.P.
on December 8, 2004 to nil
as at
December 31
, 2006.
Impairment of
Intangible Assets
Prior to the termination of the
Distribution Agreement on February 25, 2008, the Company's
intangible assets
consist
ed
of the value
of that distribution
agreement
with Asahi
Medical
and
the distribution agreement the Company
have with
Diamed and MeSys,
the designer and
the
manufacturer, respectively,
of the OctoNova pump
s
. The Rheofilter filter,
the
Plasmaflo filter and
the
OctoNova pump are components of the
RHEO™ System.
On
November 1, 2007,
the Company
announced an indefinite suspension of
the RHEO™ System clinical development program for
Dry
AMD
and is in the process of winding down
the RHEO-AMD study as there is no reasonable prospect that the RHEO™ System
clinical development program will be relaunched in the foreseeable
future
.
In accordance with SFAS No. 144,
the Company
concluded that
its
indefinite suspension of
the RHEO™ System clinical development
program for Dry AMD
was a
significant event which may affect the carrying value of its distribution
agreements. Accordingly, m
anagement
was required to re-assess whether
the
carrying
value of
the Company's
distribution agreements was
recoverable
as of
December 31
, 2007.
Based on management’s estimates of
undiscounted cash flows associated with the distribution agreements, the Company
concluded that the carrying value of the distribution agreements was not
recoverable as of December 31, 2007. Accordingly, we recorded an impairment
charge of $20,923,028 during the year ended December 31, 2007 to record the
distribution agreements at their fair value as of December 31,
2007. There was no comparable expense
during the years ended December 31, 2006 and 2005.
Restructuring
Charges
In accordance with SFAS No. 146,
“Accounting for Costs Associated with Exit or Disposal Activities”
(“SFAS No. 146”), we recognized a total
of $1,312,721 and $819,642 in restructuring charges during the years ended
December 31, 2007 and 2006, respectively. With the suspension of the Company's
RHEO™ System clinical development program, and the consequent winding-down of
the RHEO-AMD study, and the Company's disposition of SOLX during the year ended
December 31, 2007, we have reduced its workforce considerably. During 2006, the
Company implemented a number of structural and management changes designed both
to support the continued development of the RHEO™ System and to execute the
Company's accelerated diversification strategy within ophthalmology. The
restructuring charges of $1,312,721 and $819,642, recorded in the years ended
December 31, 2007 and 2006, respectively, consist solely of severance and
benefit costs related to the termination of certain of the Company's employees
at the Company's
Palm
Harbor
and
Mississauga
offices. The severance and benefit
costs recorded during the year ended December 31, 2007 were yet to be paid by
December 31, 2007. There was no comparable expense in the year ended December
31, 2005.
Other Income, Net
For the years ended December
31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
Change
|
|
|
200
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
$
|
610
|
|
|
|
(55
|
)%
|
|
$
|
1,370
|
|
|
|
(14
|
)%
|
|
$
|
1,593
|
|
Changes in fair value of warrant
obligation
|
|
|
1,882
|
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
N/M
|
*
|
|
|
—
|
|
Impairment of
investments
|
|
|
(1,036
|
)
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
N/M
|
*
|
|
|
—
|
|
Interest
expense
|
|
|
(17
|
)
|
|
|
(13
|
)%
|
|
|
(15
|
)
|
|
|
N/M
|
*
|
|
|
—
|
|
Other income
(expense)
|
|
|
18
|
|
|
|
(42
|
)%
|
|
|
31
|
|
|
|
154
|
%
|
|
|
(57
|
)
|
Minority
interest
|
|
|
1,312
|
|
|
|
715
|
%
|
|
|
161
|
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
$
|
2,769
|
|
|
|
79
|
%
|
|
$
|
1,547
|
|
|
|
2
|
%
|
|
$
|
1,536
|
|
* N/M – Not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Income
Interest income consists of interest
income earned in the current period
and the corresponding prior periods as
a result of the Company's cash and short-term investment position following the
raising of capital in the Company's initial public offering in December 2004 and
in the private placement of the Shares and Warrants in February
2007.
The continued decrease in interest
income during years ended December 31, 2007 and 2006, when compared to the
corresponding period in fiscal 2005, is due to the utilization of the funds
raised in order
to finance
infrastructure costs,
to
accumulate inventory and
to fund costs of the MIRA-1
and
RHEO-AMD
trials
and other clinical trials and, more
recently
,
to acquire SOLX and OcuSense in line
with our diversification strategy.
Changes in Fair Value of Warrant
Obligation
On February 6, 2007, pursuant to the
Securities Purchase Agreement between the Company and certain institutional
investors,
the
Company
issued the Warrants
to these investors. The Warrants are five-year warrants exercisable into an
aggregate of 2,670,933 shares of
the Company's
common stock. On February 6, 2007,
the Company
also issued the Cowen Warrant to Cowen
and Company, LLC in part payment of the placement fee payable to Cowen and
Company, LLC for the services it had rendered as the placement agent in
connection with the private placement of the Shares and the Warrants. The Cowen
Warrant is a five-year warrant exercisable into an aggregate of 93,483 shares of
the Company's
common stock. The per share exercise
price of the Warrants is $2.20, subject to adjustment, and the Warrants became
exercisable on August 6, 2007. All of the terms and conditions of the Cowen
Warrant (other than the number of shares of
the Company's
common stock into which it is
exercisable) are identical to those of the Warrants. T
he Company
account for the Warrants and the Cowen
Warrant in accordance with the provisions of SFAS No. 133 along with related
interpretation EITF 00-19. Based on the provisions of EITF 00-19,
the Company
determined that the Warrants and the
Cowen Warrant do not meet the criteria for classification as equity.
Accordingly,
the
Company
ha
ve
classified the Warrants and the Cowen
Warrant as a current liability as at
December 31
, 2007. The estimated fair value was
determined using the Black-Scholes option-pricing model. In addition, SFAS No.
133 requires
us
to
record the outstanding
derivatives at fair value at the end of each reporting period resulting in an
adjustment to the recorded liability of the derivative, with any gain or loss
recorded in earnings of the applicable reporting period. T
he Company
therefore estimated the fair value of
the Warrants and the Cowen Warrant as at
December 31
, 2007 and determined the aggregate fair
value to be
a nominal
amount
, a decrease of
approximately
$
2,052,578
over the initial measurement of the
aggregate fair value of the Warrants and the Cowen Warrant on the date of
issuance.
Changes in fair value of warrant
obligation for the
year
ended December 31
, 2007
includes a gain of $
2,052,578
which reflect the decrease in the fair
value of the Warrants and the Cowen Warrant at
December 31
, 2007 over their fair value
on the date of
issuance
. Transaction costs
associated with the issuance of the Warrants of $170,081 have also been recorded
as a warrant expense in
the
Company's
consolidated
statement of operations for the
year
ended
December 31
, 2007
.
There was no comparable
net
gain recorded in the
years ended December 31, 2006 and
2005
.
Impairment
of investments
As at December 31, 2007, we had
investments in the aggregate principal amount of $1,900,000 which consist of
investments in four separate asset-backed auction rate securities yielding an
average return of 5.865% per annum. However, as a result of market
conditions, all of these investments have recently failed to settle on their
respective settlement dates and have been reset to be settled at a future date
with an average maturity of 46 days. Based on discussions with
the Company's
advisors and the current lack of
liquidity for asset-backed securities of this type,
we
concluded that the carrying value of
these investments was higher than its fair value as of December 31, 2007.
Accordingly, these auction rate securities have been recorded at their estimated
fair value of $
863,
750.
We
consider this to be
an other-than-temporary
reduction in the value
of these auction rate
securities.
A
ccordingly, the
impairment
associated with these auction rate
securities of $1,
036
,250 has been included as a
n impairment of
investments in
our
consolidated statement of operations
for the year ended December 31, 2007.
Impairment of investments for the year
ended December 31, 2007 reflect the decrease in the fair value of the Company's
investments in
asset-backed
auction rate securities
as
at December 31, 2007.
There
was no comparable
expense
recorded in the
years ended December 31, 2006 and
2005
.
Interest
E
xpense
On
November 30, 2006, we announced that Elias Vamvakas, our Chairman and Chief
Executive Officer, had agreed to provide us with a standby commitment to
purchase Convertible Debentures of the Company for a Total Commitment Amount of
$8,000,000. Pursuant to the Summary of Terms and Conditions, during
the 12-month commitment term commencing on November 30, 2006, upon no less than
45 days’ written notice by us to Mr. Vamvakas, Mr. Vamvakas was obligated to
purchase Convertible Debentures in the aggregate principal amount specified in
such written notice. A commitment fee of 200 basis points was payable by us on
the undrawn portion of the total $8,000,000 commitment amount. Any Convertible
Debentures purchased by Mr. Vamvakas would have carried an interest rate of 10%
per annum and would have been convertible, at Mr. Vamvakas’ option, into shares
of the Company's common stock at a conversion price of $2.70 per share. The
Summary of Terms and Conditions of the standby commitment further provided that
if the Company closed a financing with a third party, whether by way of debt,
equity or otherwise and there are no Convertible Debentures outstanding, then,
the Total Commitment Amount was to be reduced automatically upon the closing of
the financing by the lesser of: (i) the Total Commitment Amount; and (ii) the
net proceeds of the financing. On February 6, 2007, the Company raised gross
proceeds in the amount of $10,016,000 in a private placement of shares of its
common stock and warrants. The Total Commitment Amount was therefore reduced to
zero, thus effectively terminating Mr. Vamvakas’ standby commitment. No portion
of the standby commitment was ever drawn down by the Company, and the Company
paid Mr. Vamvakas a total of $29,808 in commitment fees in February
2007.
Interest expense for the years ended
December 31, 2007 and 2006 consists primarily of the commitment fee due to Mr.
Vamvakas on the undrawn portion of the Total Commitment Amount during the
periods. There was no comparable expense during the year ended December 31,
2005.
Other
Income (Expense)
Other
income for the years ended December 31, 2007 and 2006 consists primarily of
foreign exchange gain of $22,889 and $37,229, respectively, due to exchange rate
fluctuations on the Company's foreign currency transactions. This gain was
offset by miscellaneous tax expense of $4,879 and $6,120 during the years ended
December 31, 2007 and 2006, respectively. Other expense was $57,025 for the year
ended December 31, 2005 and consists of a provision for subscription receivable
of $34,927 and miscellaneous tax expense of $23,021.
Minority Interest
As a result of the restatement of the
financial statements as discussed earlier, the amount of losses allocated to
minority interest decreased by $870,665 in the year ending December 31, 2007 and
increased by $3,555 in the year ending December 31, 2006.
The decrease in the year ending December
31, 2007 was primarily related the following
|
·
|
reflecting the minority interest
share of tax losses benefited in the year of
$816,444;
|
|
·
|
a decrease in the minority
interest applicable percentage from what was previously applied
(49.9%) to 42.38% of $342,871;
and
|
|
·
|
a decrease related to the minority
interest share of the excess of the alpha milestone payment of $2,000,000
over the estimated fair value on the date of our acquisition of OcuSense
$130,291.
|
These decreases were partially offset by
the following increases:
|
·
|
an increase in the net
amortization of intangibles and deferred tax liabilities arising from fair
valuing minority interest on the date of acquisition of $327,872,
and
|
|
·
|
the minority interest share of
losses previously not reported for reason of the minority
interest share of losses having exceeded the value of minority interest
reported on acquisition of
$91,069.
|
The minority interest share of losses in
the year ending December 31, 2007 increased by $1,151,542 from the share of
losses reported in the year ending December 31, 2006 which is consistent with
the fact that the 2006 results reflect only one month’s share of losses
subsequent to the November 30, 2006 our acquisition of
OcuSense.
Recovery of Income
Taxes
For the years ended December
31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
Change
|
|
|
200
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recovery of income taxes for
continuing operations
|
|
$
|
5,566
|
|
|
|
91
|
%
|
|
$
|
2,916
|
|
|
|
353
|
%
|
|
|
643
|
|
As a result of the restatement of the
financial statements as discussed earlier, the amount of taxes recovered
decreased by $89,326 in the year ending December 31, 2007 from what was
originally reported to $5,565,542 and increased by $27,300 from what was
originally reported to $2,915,790
in the year ending December 31,
2006.
The decrease in the year ending December
31, 2007 was primarily related the following:
|
·
|
a reversal of tax losses benefited
in the year of $381,597, ($0 in
2006), and
|
|
·
|
a decrease related to the reversal
of the amortization of deferred taxes related to the initial accounting of
the alpha payment of $2,000,000 of $35,327 ($0 in
2006)
|
These decreases were partially offset by
the following increases:
a decrease in the minority interest
applicable percentage from what was previously applied (49.9%) to
42.38% of $327,599, ($27,300 in 2006) .
As a result of the restatement of the
financial statements as discussed earlier, the amount reported as the recovery
of income taxes decreased by $89,326 in the year ending December 31, 2007 from
what was originally reported to $5,565,542 and increased by $27,300 in the year
ending December 31, 2006
from what was originally reported to
$2,915,790. The decrease in the year ending December 31, 2007 related primarily
to the reversal of tax benefits previously reported of $381,597 and the reversal
of $35,327 of the amortization of the deferred taxes originally reported
resulting from the payment by the Company of the alpha milestone to OcuSense of
$2,000,000 offset by increased amortization of deferred taxes arising from fair
valuing minority interest on the date of the acquisition of OcuSense by us of
$327,599.
Recovery of income taxes increased by
$
2,649,752
during the year ended December 31,
2007, as compared with the prior period in 2006. The increase is due to the
elimination of the deferred tax liability of $7,995,790 associated with
our
distribution intangible which was fully
impaired as at December 31, 2007. In addition, we recorded a deferred tax
recovery in the amount of $
1,863,391
associated with the recognition of the
deferred tax asset from the availability of net operating losses in the United
States of OcuSense during the 2007 fiscal year which may be utilized to reduce
taxes in future years. These increases in recovery of income taxes were offset
in part by a valuation allowance increase of $4,809,456 associated with
our
Retina division. A deferred tax asset
was recognized in prior years as the asset was believed to be more likely than
not to be realized based on existing taxable temporary
differences.
Recovery of income taxes increased by
$2,
273,261
during the year ended December 31,
2006, as compared with the prior period in 2005 due primarily to the recognition
of deferred tax asset from the availability of fiscal 2006 net operating losses
in the
United
States
which may be
utilized to reduce taxes in future years. There was no comparable benefit
recorded during the year ended December 31, 2005.
To date,
we
ha
ve
recognized income tax benefits in the
aggregate amount of $2.
2
million associated with the recognition
of the deferred tax asset from the availability of net operating losses in the
United States
which may be utilized to reduce taxes
in future years. The benefits associated with the balance of the net operating
losses are subject to a full valuation allowance since it is not more likely
than not that these losses can be utilized in future years.
Recovery
of income taxes for the years ended December 31, 2007 and 2006 also includes the
amortization of the deferred tax liability of $515,815 and $42,985,
respectively, which was recorded based on the difference between the fair value
of intangible asset acquired upon the acquisition of OcuSense on November 30,
2006 and its tax base. The increase in the amount recorded during the year ended
December 31, 2007 as compared with the corresponding period in fiscal 2006
arises because the acquisition of 57.62% of the capital stock of OcuSense, 50.1%
on a fully diluted basis, was completed by us on November 30, 2006. Therefore,
recovery of income taxes for the year ended December 31, 2006 only included one
month’s amortization of the deferred tax liability recorded upon the acquisition
of OcuSense. The deferred tax liability totaling $5,158,155 is being amortized
over a period of approximately 10 years, the estimated useful life of the
intangible asset. There was no comparable income tax benefit recorded during the
year ended December 31, 2005
Discontinued
Operations
On
December 19, 2007, the Company sold to Solx Acquisition, and Solx Acquisition
purchased from us, all of the issued and outstanding shares of the capital stock
of SOLX, which had been our glaucoma subsidiary prior to the completion of this
transaction. The consideration for the purchase and sale of all of the issued
and outstanding shares of the capital stock of SOLX consisted of: (i)
on the closing date of the sale, the assumption by Solx Acquisition of all of
the Company's liabilities related to SOLX’s business, incurred on or after
December 1, 2007, and our obligation to make a $5,000,000 payment to the former
stockholders of SOLX due on September 1, 2008 in satisfaction of the outstanding
balance of the purchase price of SOLX; (ii) on or prior to February 15, 2008,
the payment by Solx Acquisition of all of the expenses that the Company have
paid to the closing date, as they related to SOLX’s business during the period
commencing on December 1, 2007; (iii) during the period commencing on the
closing date and ending on the date on which SOLX achieves a positive cash flow,
the payment by Solx Acquisition of a royalty equal to 3% of the worldwide net
sales of the SOLX 790 Laser and the SOLX Gold Shunt, including next-generation
or future models or versions of these products; and (iv) following the date on
which SOLX achieves a positive cash flow, the payment by Solx Acquisition of a
royalty equal to 5% of the worldwide net sales of these products. In order to
secure the obligation of Solx Acquisition to make these royalty payments, SOLX
granted to the Company a subordinated security interest in certain of its
intellectual property. No value was assigned to the royalty payments as the
determination of worldwide net sales of SOLX’s products is subject to
significant uncertainty.
The Company's
results of operations related to
discontinued operation
s
for the years ended December 31,
2007
and
2006 are as follows:
|
|
December
31,
|
|
|
|
|
2007
$
|
|
|
|
2006
$
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
244,150
|
|
|
|
31,625
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
119,147
|
|
|
|
11,053
|
|
Royalty
costs
|
|
|
26,277
|
|
|
|
8,332
|
|
Total
cost of goods sold
|
|
|
145,424
|
|
|
|
19,385
|
|
Gross
profit
|
|
|
98,726
|
|
|
|
12,240
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
3,630,943
|
|
|
|
1,378,536
|
|
Clinical
and regulatory
|
|
|
2,828,686
|
|
|
|
754,624
|
|
Sales
and marketing
|
|
|
818,301
|
|
|
|
330,210
|
|
Impairment
of goodwill
|
|
|
14,446,977
|
|
|
|
—
|
|
Impairment
of intangible assets
|
|
|
22,286,383
|
|
|
|
—
|
|
|
|
|
44,011,290
|
|
|
|
2,463,370
|
|
|
|
|
(43,912,564
|
)
|
|
|
(2,451,130
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
486
|
|
|
|
—
|
|
Accretion
expense
|
|
|
(857,400
|
)
|
|
|
(273,192
|
)
|
Other
|
|
|
(9,302
|
)
|
|
|
(67
|
)
|
|
|
|
(866,216
|
)
|
|
|
(273,259
|
)
|
Loss
from discontinued operations before income taxes
|
|
|
(44,778,780
|
)
|
|
|
(2,724,389
|
)
|
Recovery
of income taxes
|
|
|
9,349,882
|
|
|
|
1,182,005
|
|
Loss
from discontinued operations
|
|
|
(35,428,898
|
)
|
|
|
(1,542,384
|
)
|
Revenues, Cost of
Goods Sold
and Gross Margin
of Discontinued
Operations
For the years ended December
31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
|
|
|
|
|
|
|
|
|
R
evenue
|
|
$
|
244
|
|
|
|
663
|
%
|
|
$
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
$
|
119
|
|
|
|
982
|
%
|
|
$
|
11
|
|
Royalty
costs
|
|
|
26
|
|
|
|
225
|
%
|
|
|
8
|
|
Total cost of
sales
|
|
$
|
145
|
|
|
|
663
|
%
|
|
$
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
G
ross margin
|
|
|
99
|
|
|
|
662
|
%
|
|
|
13
|
|
Percentage of
revenue
|
|
|
41
|
%
|
|
|
—
|
|
|
|
41
|
%
|
Revenues
Revenue consists of revenue generated
from the sale of components of the SOLX Glaucoma System.
We completed the acquisition of SOLX on
September 1, 2006. On December 20, 2007, we announced the sale of SOLX to Solx
Acquisition. The results of SOLX’s operations have therefore been included in
our consolidated financial statements from September 1, 2006 to December 19,
2007, the closing date of the sale of SOLX.
Revenue therefore includes the sale of
SOLX Gold Shunts from September 1, 2006 to December 19, 2007. There was no
comparative revenue during the year ended December 31, 2005.
Cost of Sales
Cost of
sales includes costs of goods sold and royalty costs. Our cost of goods sold
consists primarily of costs for the manufacture of the SOLX Glaucoma System,
including the costs we incur for the purchase of component parts from our
suppliers, applicable freight and shipping costs, fees related to warehousing,
logistics inventory management and recurring regulatory costs associated with
conducting business and ISO certification.
Cost of
sales includes the cost of the components of the SOLX Glaucoma System sold
during the years ended December 31, 2007 and 2006.
Gross Margin
Gross
margin on the sale of SOLX Gold Shunts was 41% during each of the years ended
December 31, 2007 and 2006.
Operating Expenses of Discontinued
Operations
For the years ended December
31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
$
|
3,631
|
|
|
|
163
|
%
|
|
$
|
1,378
|
|
Clinical and
regulatory
|
|
|
2,829
|
|
|
|
275
|
%
|
|
|
755
|
|
Sales and
marketing
|
|
|
818
|
|
|
|
148
|
%
|
|
|
330
|
|
Impairment of
goodwill
|
|
|
14,447
|
|
|
|
N/M
|
*
|
|
|
—
|
|
Impairment of intangible
assets
|
|
|
22,286
|
|
|
|
N/M
|
*
|
|
|
—
|
|
Total operating
expenses
|
|
$
|
44,011
|
|
|
|
1,687
|
%
|
|
$
|
2,463
|
|
*N/M – Not
meaningful
|
|
|
|
General and Administrative
Expenses
General
and administrative expenses increased by $2,252,407 during the year ended
December 31, 2007, as compared with the corresponding period of fiscal 2006, due
to an increase of $1,738,334 in the amortization of the intangible assets
acquired during fiscal 2006 upon the acquisition of SOLX on September 1, 2006.
SOLX employee and related travel costs and administrative expenses also
increased by $311,886 and $183,575, respectively, during the year ended December
31, 2007 as compared with the corresponding period in fiscal 2006. We acquired
SOLX on September 1, 2006. Therefore, general and administrative expenses for
the year ended December 31, 2006 include SOLX’s cost for four months to December
2006.
Clinical and Regulatory
Expenses
SOLX’s clinical and regulatory expenses
increased by
$
2,074,062
during the
year ended December 31, 2007 as compared
with the comparative
period
in 2006
.
We acquired SOLX on September 1, 2006.
Therefore, clinical and regulatory expenses for the year ended December 31, 2006
include SOLX’s cost for the four months ended December 31
2006.
Sales and Marketing
Expenses
Sales and marketing expenses increased
by $488,091 due to the increase in
SOLX’s sales and marketing expenses of
$
315,581
and increased employee and related
travel costs and administrative expenses of $107,935 and $28,686,
respectively
.
Impairment of
Goodwill
On
September 1, 2006, the Company acquired SOLX by way of a merger for a total
purchase price of $29,068,443. Of this amount, $14,446,977 was allocated to
goodwill. On December 19, 2007, the Company sold all of the issued and
outstanding shares of the capital stock of SOLX to Solx Acquisition. The sale
transaction established fair values for the Company's recorded goodwill and
certain of the Company's intangible assets. Accordingly, the Company performed
an impairment test of its recorded goodwill to re-assess whether its recorded
goodwill was impaired as at December 1, 2007. Based on the goodwill impairment
analysis performed,
the Company
concluded that a goodwill impairment charge of $14,446,977 should be recorded
during the year ended December 31, 2007 to write down the value of its recorded
goodwill to its fair value of nil as at December 31, 2007.
Impairment of
Intangible Assets
The
SOLX
sale transaction established fair values
for
the
Company's
recorded goodwill
and
the
Company's
shunt and laser
technology and regulatory and other intangible assets acquired upon the
acquisition of SOLX on September 1, 2006. Accordingly, management was required
to re-assess whether the carrying value of
the Company's
shunt and laser technology and
regulatory and other intangible assets was recoverable as of December 1, 2007.
Based on management’s estimates of undiscounted cash flows associated with these
intangible assets,
the
Company
concluded that the
carrying value of these intangible assets was not recoverable as of December 1,
2007. Accordingly,
the
Company
recorded an
impairment charge of $22,286,383 during the year ended December 31, 2007 to
record the shunt and laser technology and regulatory and other intangible assets
at their fair value as of December 31, 2007
.
Other Expense
of Discontinued
Operations
For the years ended December
31,
(in thousands)
|
|
20
07
|
|
|
Change
|
|
|
200
6
|
|
|
|
|
|
|
|
|
|
|
|
Accretion
expense
|
|
$
|
(857
|
)
|
|
|
(214
|
)%
|
|
$
|
(273
|
)
|
Other
expense
|
|
|
(9
|
)
|
|
|
N/M
|
*
|
|
|
—
|
|
|
|
$
|
(866
|
)
|
|
|
(217
|
)%
|
|
$
|
(273
|
)
|
* N/M – Not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion
E
xpense
In
connection with the acquisition of SOLX on September 1, 2006, we remained
indebted to the former stockholders of SOLX in an aggregate amount of up to
$13,000,000 for the outstanding portion of the purchase price of SOLX.
$5,000,000 of this amount was payable in cash on the second anniversary of the
September 1, 2006 closing. The $5,000,000 was recorded as a long-term
liability at its present value, discounted at the incremental borrowing rate of
the Company as at August 1, 2006. The difference between the discounted value
and the $5,000,000 payable was being amortized using the effective yield method
over the two-year period with the monthly expense being charged as an interest
expense in the Company's consolidated statement of operations.
Accretion expense for the year ended
December 31, 2007 and 2006 consists primarily of the accretion expense for the
years ended December 2007 and 2006.
Recovery of Income Taxes
of Discontinued
Operations
For the years ended December
31,
(in thousands)
|
|
20
07
|
|
|
Change
|
|
|
200
6
|
|
|
|
|
|
|
|
|
|
|
|
Recovery of income
taxes
|
|
$
|
9,350
|
|
|
|
691
|
%
|
|
$
|
1,182
|
|
Recovery of Income
Taxes
Recovery of income taxes increased by
$
8,167,877
during the year ended December 31,
2007, as compared with the prior period in 2006.
The increase is
primarily
due
to the elimination of the deferred tax
liability of $11,861,145 associated with the intangible assets acquired upon the
acquisition of SOLX on September 1, 2006 as these intangible assets were
impaired as at December 31, 2007. This increase in recovery of income taxes were
offset in part by a valuation allowance increase of $2,511,263 associated with
the Company's Glaucoma division. A deferred tax asset was recognized in prior
years as the asset was believed to be more likely than not to be realized based
on existing taxable temporary differences.
The
recovery of income taxes was $1,182,005 during the year ended December 31, 2006
primarily due to the recognition of the deferred tax asset of $773,395 from the
availability of fiscal 2006 net operating losses in the United States which may
be utilized to reduce taxes in future years. Also impacting the recovery of
income taxes was the amortization of the deferred tax liability of $409,055
which was recorded based on the difference between the fair value of intangible
assets acquired and its tax bases.
LIQUIDITY AND CAPITAL
RESOURCES
As at
December 31,
(in thousands)
|
|
2007
|
|
|
2006
|
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
2,236
|
|
|
$
|
5,741
|
|
|
$
|
(3,505
|
)
|
Short-term
investments
|
|
|
—
|
|
|
|
9,785
|
|
|
|
(9,785
|
)
|
Total cash and cash equivalents
and short-term investments
|
|
$
|
2,236
|
|
|
$
|
15,526
|
|
|
$
|
(13,290
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of total
assets
|
|
|
15
|
%
|
|
|
16
|
%
|
|
(1) pt
|
|
Working capital
(deficiency)
|
|
$
|
(997
|
)
|
|
$
|
13,539
|
|
|
$
|
(14,536
|
)
|
In December 2004, we raised $67,200,000
of gross cash proceeds (less issuance costs of $7,858,789) in an initial public
offering of shares of its common stock. Immediately prior to the offering, the
primary source of the Company's liquidity was cash raised through the issuance
of debentures.
On
February 6, 2007, the Company raised gross proceeds in the amount of $10,016,000
(less issuance costs of
approximately $750,000)
in a private placement of shares of its common
stock and warrants.
On
February 19, 2008, the Company announced that we secured a bridge loan in an
aggregate principal amount of $3,000,000 (less transaction costs of
approximately $200,000) from a number of private parties. The loan bears
interest at a rate of 12% per annum and has a 180-day term, which may be
extended to 270 days under certain circumstances. The repayment of the loan is
secured by a pledge by the Company of its shares of the capital stock of
OcuSense.
To date,
cash has been primarily utilized to finance increased infrastructure costs, to
accumulate inventory and to fund costs of the MIRA-1, LEARN and RHEO-AMD trials
and other clinical trials and to acquire SOLX and OcuSense in line with our
diversification strategy. With the suspension of the Company's RHEO™ System
clinical trial development program, and the consequent winding-down of the
RHEO-AMD study, and the Company's disposition of SOLX, we expect that, in the
future, we will use our cash resources to complete the product development of
OcuSense’s TearLab™ test for DED and conduct the clinical trials that will be
required for the TearLab™ test for DED. In addition, we remain indebted to
OcuSense in an aggregate amount of up to $2,000,000 for the outstanding portion
of the purchase price of the capital stock of OcuSense that we acquired on
November 30, 2006. We currently expect this amount to become due and payable
during the first half of 2008. Furthermore, we are legally committed to make an
additional equity investment of $3,000,000 upon receipt, if any, from the FDA of
a 510(k) clearance for the TearLab™ test for DED and another additional equity
investment of $3,000,000 upon receipt, if any, from the FDA of a CLIA waiver for
the TearLab™ test for DED.
Currently,
we anticipate that the net proceeds of the loan, together with the Company's
other cash and cash-equivalents, will be sufficient to sustain the Company's
operations only until approximately the end of April 2008 (assuming that the
outstanding obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due
and payable prior to the end of April 2008).
As at
December 31, 2007, we had investments in the aggregate principal amount of
$1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. Contractual maturities for these auction rate securities range
from 33 to 39 years, with an average interest reset date of approximately 46
days. Historically, the carrying value of auction rate securities approximated
their fair value due to the frequent resetting of interest rates. However, as a
result of market conditions associated with the liquidity issues experienced in
the global credit and capital markets, all of these investments have recently
failed to settle on their respective settlement dates and have been reset to be
settled at a future date with an average maturity of 46 days.
Due to
the current lack of liquidity for asset-backed securities of this type, we
concluded that the carrying value of these investments was higher than its fair
value as of December 31, 2007. Accordingly, these auction rate securities have
been recorded at their estimated fair value of $863,750, which represents a
decline of $1,036,250 in the carrying value of these auction rate securities. We
estimated the fair value of these auction rate securities based on the
following: (i) the underlying structure of each security; (ii) the present value
of future principal and interest payments discounted at rates considered to
reflect current market conditions; (iii) consideration of the probabilities of
default, auction failure, or repurchase at par for each period; and (iv)
estimates of the recovery rates in the event of default for each
security. This estimated fair value could change significantly based
on future market conditions.
We
determined the reduction in the value of these auction rate securities to be an
other-than-temporary reduction in value. Accordingly, the impairment associated
with these auction rate securities of $1,036,250 has been included as an
impairment of investments in our consolidated statement of operations for the
year ended December 31, 2007. Our conclusion for the other-than-temporary
impairment is based on the Company's current liquidity position. Although we
continue to receive payment of interest earned on these securities, we do not
know at the present time when we will be able to convert these investments into
cash. Accordingly, management has classified these investments as a
non-current asset on its consolidated balance sheet as of December 31, 2007.
Management will continue to closely monitor these investments for future
indications of further impairment. If the current market conditions deteriorate
further, or the anticipated recovery in market values does not occur, we may be
required to record additional impairment charges in fiscal 2008.
The
illiquidity of these investments may have an adverse impact on the length of
time during which we currently expect to be able to sustain our operations in
the absence of an additional capital raise by the Company as we do not have the
ability to hold these auction rate securities until the market recovers nor can
we hold these securities until their contractual maturity dates.
Years ended
December 31,
(in thousands)
|
|
200
7
|
|
|
Change
|
|
|
200
6
|
|
|
Change
|
|
|
200
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in operating
activities
|
|
$
|
(17,217
|
)
|
|
$
|
(2,669
|
)
|
|
$
|
(14,548
|
)
|
|
$
|
4,162
|
|
|
$
|
(18,710
|
)
|
Cash provided
by
investing
activities
|
|
|
4,510
|
|
|
|
(5,908
|
)
|
|
|
10,418
|
|
|
|
(33
|
)
|
|
|
10,451
|
|
Cash provided by financing
activities
|
|
|
9,202
|
|
|
|
8,931
|
|
|
|
271
|
|
|
|
(57
|
)
|
|
|
328
|
|
Net
(
decrease
) increase
in cash and cash equivalents
during the
year
|
|
$
|
(3,505
|
)
|
|
$
|
354
|
|
|
$
|
(3,859
|
)
|
|
$
|
4,072
|
|
|
$
|
(7,931
|
)
|
Cash Used in Operating
Activities
Net cash
used to fund our operating activities during the year ended December 31, 2007
was $17,217,438. Net loss during the year was $69,829,983. The
non-cash charges which comprise a portion of the net loss during that period
consisted primarily of the intangible assets and goodwill impairment of
$57,656,388 and the amortization of intangible assets, fixed assets, patents and
trademarks and accretion expense of $6,349,148 netted by applicable deferred
income taxes of $14,915,425 and minority interest of $1,312,178. Additional
non-cash charges consist of $480,971 in stock-based compensation charges and
impairment of investments of $1,036,250 netted by the change in the fair value
of warrant obligation of $1,882,497.
The net change
in non-cash working capital balances
related to operations for the years ended December 31, 2007, 2006 and 2005
consists of the following:
|
|
Years
ended December 31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
2005
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due
to related party
|
|
|
—
|
|
|
|
(5,065
|
)
|
|
|
13,291
|
|
Amounts
receivable
|
|
|
(58,782
|
)
|
|
|
390,634
|
|
|
|
(82,810
|
)
|
Inventory
|
|
|
2,756,759
|
|
|
|
2,250,554
|
|
|
|
(3,431,743
|
)
|
Prepaid
expenses
|
|
|
37,951
|
|
|
|
247,361
|
|
|
|
(322,455
|
)
|
Accounts
payable
|
|
|
797,415
|
|
|
|
(1,225,575
|
)
|
|
|
301,457
|
|
Accrued
liabilities
|
|
|
911,987
|
|
|
|
(1,155,335
|
)
|
|
|
(563,925
|
)
|
Deferred
revenue and rent inducement
|
|
|
—
|
|
|
|
—
|
|
|
|
(485,047
|
)
|
Due
to stockholders
|
|
|
(109,842
|
)
|
|
|
(5,827
|
)
|
|
|
(358,523
|
)
|
Other
current assets
|
|
|
7,000
|
|
|
|
12,781
|
|
|
|
4,105
|
|
|
|
|
4,342,488
|
|
|
|
509,528
|
|
|
|
(4,925,650
|
)
|
·
|
Amounts receivable increased due
primarily to the expected repayment by Solx Acquisition, on or prior to
February 15, 2008, in accordance with the stock purchase agreement between
the Company and Solx Acquisition, of all the expenses relating to the SOLX
business that we had paid.
|
·
|
Decrease in inventory balance
reflects the write-down of inventory and the provision for obsolescence
for inventory we are not expected to be able to sell prior to their
expiration dates.
|
·
|
Decrease in prepaid expenses is
primarily due to the expensing of advance payments made to various
organizations involved in the RHEO-AMD trial due to our suspension of the
trial, offset in part by prepaid insurance
premiums.
|
·
|
Accounts payable and accrued
liabilities increased and reflect amounts owed for costs associated with
the Company's activities.
|
·
|
The decrease in amounts due to
stockholders is due to payments made to TLC Vision during the year ended
December 31, 200
7 for
its payment of benefits of certain of our employees and for computer and
administrative support
.
|
Cash Provided by Investing
Activities
Net cash
provided by
investing activities for the
year ended December
31
, 2007
is
$
4,510,838
and consists of the net sale of
short-term investments of $7,885,000 offset in part by the payment of $3,000,000
to the former stockholders of SOLX in connection with the payment of the
purchase price, cash in the amount of $267,934 used to acquire fixed assets
and
cash in the amount of
$106,228
used to protect
and maintain patents and trademarks.
Net cash
provided by investing activities for the year ended December 31, 2006 was
$10,418,156 and resulted from cash generated from the sale of short-term
investments of $21,841,860. Cash used in investing activities during the period
consists of $255,886 used to acquire fixed assets and $105,217 used to protect
and maintain patents and trademarks. Additional cash used in investing
activities includes cash of $7,906,968 paid by the Company, including costs of
acquisition, to acquire SOLX net of cash acquired from SOLX of $34,719. In
addition, the Company advanced a total of $2,434,537 to SOLX to support its
operations prior to the acquisition. The Company also invested $2,076,312 to
acquire 50.1% of the capital stock of OcuSense, on a fully diluted basis, 57.62%
on an issued and outstanding basis, including acquisition costs of $76,312. Cash
acquired upon the acquisition of OcuSense was $1,320,497. The $2,076,312
invested by us in OcuSense has been utilized to fund the operations of
OcuSense.
Cash Provided by Financing
Activities
Net cash provided by financing
activities for the
year
ended December 31
, 2007 was
$
9,201,735
and is made up of gross proceeds in the
amount of $10,016,000
raised in
the
February 2007
private placement of
the Shares and the Warrants,
less issuance costs of $
871,215
which includes the fair value of the
Cowen W
arrant
of $97,222
issued in part payment of the placement
fee
owed to Cowen and
Company, LLC
.
Cash provided by financing activities
also includes
cash
received
in the amount of
$2,228
from the exercise of
options to purchase shares of common stock of the Company
, offset by additional share issuance
costs of $42,500 in respect of the shares issued to the former stockholders of
SOLX in part payment of the purchase price of SOLX.
Net cash
provided by financing activities for the year ended December 31, 2006 was
$270,935 and reflects cash received from the exercise of options to purchase
shares of common stock of the Company.
Borrowings
On November 30, 2006, we announced that
Elias Vamvakas, our Chairman and Chief Executive Officer, had agreed to provide
us with a standby commitment to purchase Convertible Debentures of the Company
for a
Total Commitment
Amount
of
$8,000,000.
Pursuant to the Summary of Terms and
Conditions, during the 12-month commitment term commencing on November 30, 2006,
upon no less than 45 days’ written notice by the Company to Mr. Vamvakas, Mr.
Vamvakas was obligated to purchase Convertible Debentures in the aggregate
principal amount specified in such written notice. A commitment fee of 200 basis
points was payable by the Company on the undrawn portion of the total $8,000,000
commitment amount. Any Convertible Debentures purchased by Mr. Vamvakas would
have carried an interest rate of 10% per annum and would have been convertible,
at Mr. Vamvakas’ option, into shares of
the Company's
common stock at a conversion price of
$2.70 per share. The Summary of Terms and Conditions of the standby commitment
further provided that if
the Company
closed a financing with a third party,
whether by way of debt, equity or otherwise and there are no Convertible
Debentures outstanding, then, the Total Commitment Amount was to be reduced
automatically upon the closing of the financing by the lesser of: (i) the Total
Commitment Amount; and (ii) the net proceeds of the financing. On February 6,
2007,
the
Company
raised gross
proceeds in the amount of $10,016,000 in a private placement of shares of its
common stock and warrants. The Total Commitment Amount was therefore reduced to
zero, thus effectively terminating Mr. Vamvakas’ standby commitment. No portion
of the standby commitment was ever drawn down by the Company, and the Company
paid Mr. Vamvakas a total of $29,808 in commitment fees in February
2007.
Contractual
Obligations and Contingencies
The
following table summarizes our contractual commitments as of December 31, 2007
and the effect those commitments are expected to have on liquidity and cash flow
in future periods.
|
|
Payments
Due by Period
|
|
Contractual
Commitments
|
|
Total
|
|
|
Less
than
1
year
|
|
|
1
to 3 years
|
|
|
More
than
3
years
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
leases
|
|
|
445,202
|
|
|
|
197,374
|
|
|
|
247,828
|
|
|
|
—
|
|
Royalty
payments
|
|
|
1,517,000
|
|
|
|
135,000
|
|
|
|
405,000
|
|
|
|
977,000
|
|
Consulting
and non-competition agreements
|
|
|
206,286
|
|
|
|
153,286
|
|
|
|
56,000
|
|
|
|
|
|
On
November 30, 2006, pursuant to the Series A Preferred Stock Purchase Agreement
between us and OcuSense, we purchased 1,744,223 shares of OcuSense’s Series A
Preferred Stock representing 50.1% of OcuSense’s capital stock on a fully
diluted basis, 57.62% on an issued and outstanding basis, for an
aggregate purchase price of up to $8,000,000. On the closing of the purchase
which took place on November 30, 2006, we paid $2,000,000 of the purchase price.
We paid another $2,000,000 installment of the purchase price on January 3, 2007.
We
agreed to make additional payments
totaling $4,000,000 upon the attainment of two pre-defined milestones by
OcuSense prior to May 1, 2009. In June 2007, we paid OcuSense a total of
$2,000,000 upon the attainment of the first of the two pre-defined milestones.
We will pay the last $2,000,000 installment of the purchase price upon
the attainment by OcuSense of the second of such milestones, provided that the
milestone is achieved prior to May 1, 2009. The Series A Preferred Stock
Purchase Agreement also makes provision for an ability on our part to increase
our ownership interest in OcuSense for nominal consideration if OcuSense fails
to meet certain milestones by specified dates. In addition, pursuant to the
Series A Preferred Stock Purchase Agreement, we have agreed to purchase
$3,000,000 of shares of OcuSense’s Series B Preferred Stock, which shall
constitute 10% of OcuSense’s capital stock on a fully diluted basis at the time
of purchase, upon OcuSense’s receipt from the FDA of 510(k) clearance for the
DED Test and to purchase another $3,000,000 of shares of OcuSense’s Series B
Preferred Stock, which shall constitute an additional 10% of OcuSense’s capital
stock on a fully diluted basis at the time of purchase, upon OcuSense’s receipt
from the FDA of CLIA waiver for the DED Test.
Pursuant
to the terms of our distribution agreement with MeSys GmbH, or MeSys, dated
January 1, 2002, we undertook a minimum purchase commitment of 25 OctoNova pumps
per year beginning after FDA approval of the RHEO™ System, representing an
annual commitment after FDA approval of €405,000, or approximately $534,900. The
marketing and distributorship agreement with Diamed provides for a minimum
purchase of 1,000 OctoNova pumps during the period from the date of the
agreement until the end of the five-year period following receipt of FDA
approval, representing an aggregate commitment of €16,219,000, or approximately
$23,871,935, based on exchange rates as of December 31, 2007.
Off-Balance-Sheet
Arrangements
As of
December 31, 2007, we did not have any significant off-balance-sheet
arrangements as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.
Financial Condition
Management believes that the existing
cash and cash equivalents and short-term investments, together with the net
proceeds of the bridge loan, will be sufficient to fund the Company's
anticipated level of operations and other demands and commitments until
approximately the end of April 2008 (assuming that the outstanding obligation of
OccuLogix to pay $2,000,000 to OcuSense becomes due and payable prior to the end
of April 2008).
As at
December 31, 2007, we had investments in the aggregate principal amount of
$1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at a future date with an average maturity of
46 days. Based on discussions with the Company's advisors and the
current lack of liquidity for asset-backed securities of this type, we concluded
that the carrying value of these investments was higher than its fair value as
of December 31, 2007. Accordingly, these auction rate securities have been
recorded at their estimated fair value of $863,750. We consider this to be an
other-than-temporary reduction in the value, accordingly, the impairment
associated with these auction rate securities of $1,036,250 has been included as
an impairment of investments in our consolidated statement of operations for the
year ended December 31, 2007. Although we continue to receive payment of
interest earned on these securities, we do not know at the present time when it
will be able to convert these investments into cash. Accordingly,
management has classified these investments as a non-current asset on its
consolidated balance sheet as of December 31, 2007. Management will continue to
closely monitor these investments for future indications of further impairment.
The illiquidity of these investments may have an adverse impact on the length of
time during which we currently expect to be able to sustain its operations in
the absence of an additional capital raise by the Company.
Our
forecast of the period of time through which our financial resources will be
adequate to support our operations is a forward-looking statement and involves
risks and uncertainties. Actual results could vary as a result of a number of
factors. We have based this estimate on assumptions that may prove to be wrong,
and we could utilize our available capital resources sooner than we currently
expect. Our future funding requirements will depend on many factors, including
but not limited to:
|
·
|
the cost and results of
development of OcuSense’s TearLab™ test for DE
D;
|
|
·
|
the cost and results
, and the rate of
progress,
of the
clinical trials of the TearLab™ test for DE
D
that will
be required to
support OcuSense’s application to
obtain 510(k) clearance and a CLIA waiver from the FDA to market and sell
the TearLab™ test for DE
D
in the United States
;
|
|
·
|
OcuSense’s ability to obtain
510(k) approval and a CLIA waiver from the FDA
for
the TearLab™ test for
DE
D
and the timing of such approval,
if any
;
|
|
·
|
whether government and third-party
payors agree to reimburse treatments using the TearLab™ test for
DE
D;
|
|
·
|
the costs and timing of building
the infrastructure to market and sell the TearLab™ test for DE
D;
|
|
·
|
t
he costs of filing, prosecuting,
defending and enforcing any patent claims and other intellectual property
rights
;
and
|
|
·
|
the effect of competing
technological and market
developments.
|
With the
suspension of the Company's RHEO™ System clinical development program, and the
consequent winding-down of the RHEO-AMD study, and the Company's disposition of
SOLX, the Company no longer has any operating business. Its major asset is its
50.1% ownership stake, on a fully diluted basis, 57.62% on an issued and
outstanding basis, in OcuSense. Accordingly, unless we acquire other businesses
(which, in light of the Company's financial condition, is unlikely to occur),
our ability to generate any revenues will be dependent almost entirely upon the
success of OcuSense.
We cannot
begin commercialization of the TearLab™ test for DED in the United States until
we receive FDA approval. At this time, we do not know when we can expect to
begin to generate revenues from the TearLab™ test for DED in the United
States.
We will
need additional capital in the future, and our prospects for obtaining it are
uncertain. On October 9, 2007, we announced that the Board had authorized
management and the Company's advisors to explore the full range of strategic
alternatives available to enhance shareholder value, including, but not limited
to, the raising of capital through the sale of securities, one or more strategic
alliances and the combination, sale or merger of all or part of the Company. For
some time prior to the October 9, 2007 announcement, the Company had been
seeking to raise additional capital, with the objective of securing funding
sufficient to sustain its operations as it had been clear that, unless we were
able to raise additional capital, the Company would not have had sufficient cash
to support its operations beyond early 2008. Although the Company secured a
bridge loan in an aggregate principal amount of $3,000,000 from a number of
private parties on February 19, 2008, management believes that these net
proceeds, together with the Company's existing cash and cash-equivalents, will
be sufficient to cover its operating activities and other demands only until
approximately the end of April 2008
(assuming that the outstanding
obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due and payable
prior to the end of April 2008)
. Additional capital may not be available
on terms favorable to us, or at all. In addition, future financings could result
in significant dilution of existing stockholders. However, unless we succeed in
raising additional capital, we will be unable to continue our operations. See
“Risk Factors—Risks Relating to Our Business—Our financial condition and history
of losses have caused our auditors to express doubt as to whether we will be
able to continue as a going concern.”
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations is
based upon our audited consolidated financial statements, which have been
prepared in accordance with accounting principles generally accepted in the
United States. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amount of assets, liabilities,
sales and expenses, and related disclosure of contingent assets and liabilities.
On an ongoing basis, we evaluate our estimates, including those related to our
intangible assets, uncollectible receivables, inventories, goodwill and
stock-based compensation. We base our estimates on historical experience and on
various other assumptions that we believe to be reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying value of assets and liabilities that are not readily apparent from
other sources. Because this can vary in each situation, actual results may
differ from these estimates under different assumptions or
conditions.
We
believe the following critical accounting policies affect our more significant
judgments and estimates used in the preparation of our audited consolidated
financial statements.
Revenue
Recognition
The
Company recognized revenue from the sale of the RHEO™ System, prior to the
Company's announcement of the indefinite suspension of its RHEO™ System clinical
development program, which is comprised of OctoNova pumps and the related
disposable treatment sets and, prior to the Company's disposition of SOLX on
December 19, 2007, from the sale of the components of the SOLX Glaucoma System
which includes the SOLX 790 Titanium Sapphire Laser (“SOLX 790 Laser”) and the
SOLX Gold Shunt. The Company received a signed binding purchase order from its
customers. The pricing was a negotiated amount between the Company and its
customers. The Company sold the components of the SOLX Glaucoma System directly
to physicians and also through distributors. Revenue has been reported net of
distributors’ commissions.
The
Company had the obligation to train its customers and to calibrate the OctoNova
pumps delivered to them. Only upon the completion of these services did the
Company recognize revenue for the pumps. The Company were also responsible for
providing a one-year warranty on the OctoNova pumps, and the estimated cost of
providing this service was accrued at the time revenue is recognized. The
treatment sets and the components of the SOLX Glaucoma System did not require
any additional servicing and revenue was recognized upon passage of title.
However, the Company's revenue recognition policy requires an assessment as to
whether collectibility is reasonably assured, which requires the Company to
evaluate the creditworthiness of its customers. The result of the assessment
could materially impact the timing of revenue recognition.
Bad
Debt Reserves
The
Company evaluates the collectibility of its accounts receivable based on a
combination of factors. In cases where management is aware of circumstances that
may impair a specific customer’s ability to meet its financial obligations to
the Company, a specific allowance against amounts due to the Company is
recorded, which reduces the net recognized receivable to the amount management
reasonably believes will be collected. For all other customers, the Company
recognizes allowances for doubtful accounts based on the length of time the
receivables are past due, the current business environment and historical
experience. As at December 31, 2007 and 2006, the Company had bad debt reserves
of $172,992 and nil, respectively. The Company expensed amounts related to bad
debt reserves of nil, nil and $518,852 during the years ended December 31, 2007,
2006 and 2005, respectively, and set up a provision for $172,992, nil and
$530,445 representing invoices for products shipped, plus related taxes, to a
customer during the years ended December 31, 2007, 2006 and 2005, respectively,
for which revenue was not recognized due to the likelihood that the customer
would not be able to pay for the amounts invoiced.
Inventory
Valuation
Inventory
is recorded at the lower of cost and net realizable value and consists of
finished goods. Cost is accounted for on a first-in, first-out basis. Deferred
cost of sales (included in finished goods) consists of products shipped but not
recognized as revenue because they did not meet the revenue recognition
criteria.
The
Company evaluates its ending inventory for estimated excess quantities and
obsolescence, based on expected future sales levels and projections of future
demand, with the excess inventory provided for. In addition, the Company
assesses the impact of changing technology and market conditions. In
addition, the Company assesses whether recent transactions provide indicators as
to whether the net realizable value of its inventory is below its recorded cost.
In April 2006, the Company sold a number of treatment sets to Veris Health
Sciences Inc. (“Veris”) at a price lower than the Company's
cost. Accordingly, the Company wrote down the value of its treatment
sets to reflect this current net realizable value during the year ended December
31, 2006. In light of the Company's current financial position, on November 1,
2007, the Company announced an indefinite suspension of the RHEO™ System
clinical development program for Dry AMD. That decision was made
following a comprehensive review of the respective costs and development
timelines associated with the products in the Company's portfolio and, in
particular, the fact that, if the Company is unable to raise additional
capital, it will not have sufficient cash to support its operations beyond early
2008. Accordingly, the Company has written down the value of its treatment sets
and OctoNova pumps, the components of the RHEO™ System, to nil as of December
31, 2007 since we are not expected to be able to sell or utilize these treatment
sets and OctoNova pumps prior to their expiration dates, in the case of the
treatment sets, or before the technologies become outdated.
As at
December 31, 2007 and 2006, the Company had inventory reserves of $7,295,545 and
$5,101,394, respectively. During the years ended December 31, 2007, 2006 and
2005, the Company recognized a provision related to inventory of $2,790,209,
$3,304,124 and $1,990,830, respectively, based on the above
analysis.
Impairment
of long-lived
assets
We review
our fixed assets and intangible assets for impairment whenever events or changes
in circumstances indicate that the carrying amount of an asset might not be
recoverable. When such an event occurs, management estimates the future
undiscounted cash flows expected to result from the use of the asset and its
eventual disposition. In the event the undiscounted cash flows are less than the
carrying amount of the asset, a further analysis is required to estimate the
fair value of the asset using the discounted cash flow method and then an
impairment loss equal to the excess of the carrying amount over the fair value
is charged to operations.
Our
intangible assets consist of the value of the exclusive distribution agreements
we have with Asahi Medical and MeSys and other acquisition-related intangibles
arising from our acquisition of SOLX and OcuSense during fiscal 2006 prior to
the sale of SOLX on December 19, 2007. The distribution agreements and other
acquisition-related intangible assets are amortized using the straight-line
method over an estimated useful life of 15 and 10 years,
respectively.
On
November 1, 2007, we announced an indefinite suspension of the RHEO™ System
clinical development program for Dry AMD and are in the process of winding down
the RHEO-AMD study as there is no reasonable prospect that the RHEO™ System
clinical development program will be relaunched in the foreseeable
future. In accordance with SFAS No. 144, we concluded that its
indefinite suspension of the RHEO™ System clinical development program for Dry
AMD was a significant event which may affect the carrying value of the Company's
distribution agreements. Accordingly, management was required to re-assess
whether the carrying value of our distribution agreements was recoverable as of
December 31, 2007. Based on management’s estimates of undiscounted cash flows
associated with the distribution agreements, we concluded that the carrying
value of the distribution agreements was not recoverable as of December 31,
2007. Accordingly, we recorded an impairment charge of $20,923,028 during the
year ended December 31, 2007 to record the distribution agreements at their fair
value as of December 31, 2007.
On
December 19, 2007, we sold to Solx Acquisition, all of the issued and
outstanding shares of the capital stock of SOLX. The sale transaction
established fair values for the Company's recorded goodwill and the Company's
shunt and laser technology and regulatory and other intangible assets acquired
upon the acquisition of SOLX on September 1, 2006. Accordingly, management was
required to re-assess whether the carrying value of the Company's shunt and
laser technology and regulatory and other intangible assets was recoverable as
of December 1, 2007. Based on management’s estimates of undiscounted cash flows
associated with these intangible assets, we concluded that the carrying value of
these intangible assets was not recoverable as of December 1, 2007. Accordingly,
we recorded an impairment charge of $22,286,383 during the year ended December
31, 2007 to record the shunt and laser technology and regulatory and other
intangible assets at their fair value as of December 31, 2007.
The
Company determined that, as at December 31, 2007, there have been no significant
events which may affect the carrying value of its TearLab™ technology. However,
the Company's prior history of losses and losses incurred during the current
fiscal year reflects a potential indication of impairment, thus requiring
management to assess whether the OcuSense’s TearLab™ technology was impaired as
of December 31, 2007. Based on management’s estimates of forecasted undiscounted
cash flows as of December 31, 2007, the Company concluded that there is no
indication of an impairment of the OcuSense’s TearLab™ technology. Therefore, no
impairment charge was recorded during the year ended December 31,
2007.
Impairment
of Goodwill
Effective January 1, 2002, goodwill is
no longer amortized and is subject to an annual impairment test. Goodwill
impairment is evaluated between annual tests upon the occurrence of certain
events or circumstances. Goodwill impairment is assessed based on a comparison
of the fair value of the reporting unit to the underlying carrying value of the
reporting unit
’
s net assets, including goodwill. When
the carrying amount of the reporting unit exceeds its fair value, the fair value
of the reporting unit
’
s goodwill is compared with its carrying
amount to measure the amount of impairment loss, if any.
Prior to the acquisition of SOLX and
OcuSense during the second half of fiscal 2006, t
he Company
was
a single reporting unit. Therefore,
management determined the fair value of
the Company's
goodwill using
the Company's
market capitalization as opposed to the
fair value of its assets and liabilities. As a result of the announcement on
February 3, 2006,
the per
share price of
our
common
stock as traded on
NASDAQ decreased from $12.75 on February
2, 2006 to close at $4.10 on February 3, 2006. The 10-day average price of the
stock immediately following the announcement was $3.65 and reflected a decrease
in our market capitalization from $536.6 million on February 2, 2006 to $153.6
million based on the 10-day average share price subsequent to the announcement.
On June 12, 2006, we
announced that the FDA will require us to perform an additional study of the
RHEO™ System. In addition, on June 30, 2006, we announced that we had terminated
negotiations with Sowood in connection with a proposed private purchase of
approximately $30,000,000 of zero-coupon convertible notes of the Company. The
per share price of our common stock decreased subsequent to the June 12, 2006
announcement and again after the June 30, 2006 announcement. Based on the result
of the preliminary analysis of the data from MIRA-1 and the events that occurred
during the second quarter of fiscal 2006, we concluded that there were
sufficient indicators
of
impairment leading to an analysis of our intangible assets and goodwill and
resulting in our reporting an impairment charge to goodwill of $65,945,686 and
$147,451,758
during the
years ended December 31, 2006 and 2005
, respectively.
Subsequent to the acquisition of SOLX
and OcuSense, the Company determined the fair value of acquired
goodwill based
on a
comparison of the fair value of the reporting unit to the underlying carrying
value of the reporting unit
’
s net assets, including
goodwil
l.
On December 19, 2007, the Company sold
to Solx Acquisition, all of the issued and outstanding shares of the capital
stock of SOLX, which had been the glaucoma subsidiary of the Company prior to
the completion of
this
sale
. The sale transaction
established fair values for
the Company's
recorded goodwill and certain of
the Company's
intangible assets. Accordingly,
the Company
performed an impairment test of its
recorded goodwill to re-assess whether its recorded goodwill was impaired as at
December 1, 2007. Based on the goodwill impairment analysis
performed,
the Company
concluded that a goodwill impairment charge of $14,446,977 should be recorded
during the year ended December 31, 2007 to write down the value of its recorded
goodwill to its fair value of nil as at December 31, 2007.
Stock-based
Compensation
We
account for stock-based compensation in accordance with the provisions of SFAS
123R. Under the fair value recognition provision of SFAS 123R, stock-based
compensation cost is estimated at the grant date based on the fair value of the
award and is recognized as an expense ratably over the requisite service period
of the award.
We have selected the
Black-Scholes option-pricing model as our method of determining the fair value
for all our awards and will recognize compensation cost on a straight-line basis
over the awards’ vesting periods.
Impairment
of Investments
As at
December 31, 2007, we had investments in the aggregate principal amount of
$1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at a future date with an average maturity of
46 days. Due to the current lack of liquidity for asset-backed
securities of this type, the Company concluded that the carrying value of these
investments was higher than its fair value as of December 31, 2007. Accordingly,
these auction rate securities have been recorded at their estimated fair value
of $863,750. We consider this to be an other-than-temporary reduction in the
value. Accordingly, the loss associated with these auction rate securities of
$1,036,250 has been included as an impairment of investments in the Company's
consolidated statement of operations for the year ended December 31, 2007.
Although we continue to receive payment of interest earned on these securities,
we do not know at the present time when we will be able to convert these
investments into cash. Accordingly, management has classified these
investments as a non-current asset on its consolidated balance sheet as of
December 31, 2007. We will continue to closely monitor these investments for
future indications of further impairment. The illiquidity of these investments
may have an adverse impact on the length of time during which we currently
expect to be able to sustain our operations in the absence of an additional
capital raise by the Company.
Fair
Value of Warrants
On February 6, 2007, pursuant to the
Securities Purchase Agreement between the Company and certain institutional
investors,
the
Company
issued the Warrants
to these investors. The Warrants are five-year warrants exercisable into an
aggregate of 2,670,933 shares of
the Company's
common stock. On February 6, 2007,
the Company
also issued the Cowen Warrant to Cowen
and Company, LLC in part payment of the placement fee payable to Cowen and
Company, LLC for the services it had rendered as the placement agent in
connection with the private placement of the Shares and the Warrants. The Cowen
Warrant is a five-year warrant exercisable into an aggregate of 93,483 shares of
the Company's
common stock. The per share exercise
price of the Warrants is $2.20, subject to adjustment, and the Warrants became
exercisable on August 6, 2007. All of the terms and conditions of the Cowen
Warrant (other than the number of shares of
the Company's
common stock into which it is
exercisable) are identical to those of the Warrants. T
he Company
account for the Warrants and the Cowen
Warrant in accordance with the provisions of SFAS No. 133 along with related
interpretation EITF 00-19. Based on the provisions of EITF 00-19,
the Company
determined that the Warrants and the
Cowen Warrant do not meet the criteria for classification as equity.
Accordingly, the Company has classified the Warrants and the Cowen Warrant as a
current liability as at
December 31
, 2007. The estimated fair value was
determined using the Black-Scholes option-pricing model. In addition, SFAS No.
133 requires the Company to record the outstanding derivatives at fair value at
the end of each reporting period resulting in an adjustment to the recorded
liability of the derivative, with any gain or loss recorded in earnings of the
applicable reporting period. The Company therefore estimated the fair value of
the Warrants and the Cowen Warrant as at
December 31
, 2007 and determined the aggregate fair
value to be
a nominal
amount
, a decrease of
approximately
$
2,052,578
over the initial measurement of the
aggregate fair value of the Warrants and the Cowen Warrant on the date of
issuance.
Effective
Corporate Tax Rate
Income
Taxes
As of
December 31, 2007, we had net operating loss carry forwards for federal income
taxes of $75 million. Our utilization of the net operating loss and tax credit
carry forwards may be subject to annual limitations pursuant to Section 382 of
the Internal Revenue Code, and similar state provisions, as a result of changes
in our ownership structure. The annual limitations may result in the expiration
of net operating losses and credits prior to utilization.
At
December 31, 2007, we had recorded a deferred tax liability due to the
difference between the fair value of our intangible assets and their tax bases.
We also
recorded a deferred tax
asset, netted off against the deferred tax liability, from the availability of
2007 net operating losses in the
United States
which may be utilized to reduce taxes
in future years. In addition,
we also had additional deferred tax asset
representing the benefit of net operating loss carry forwards and certain stock
issuance costs capitalized for tax purposes. We did not record a benefit for
this deferred tax asset because realization of the benefit was uncertain, and,
accordingly, a valuation allowance is provided to offset the deferred tax
asset.
The
Company and its subsidiaries have current and prior year losses available to
reduce taxable income and taxes payable in future years which, if not utilized,
will expire as follows:
|
|
|
$
|
|
|
|
|
|
|
2012
|
|
|
3,455,029
|
|
2018
|
|
|
4,500,401
|
|
2019
|
|
|
1,893,700
|
|
2020
|
|
|
4,488,361
|
|
2021
|
|
|
3,356,992
|
|
2022
|
|
|
2,497,602
|
|
2023
|
|
|
1,901,399
|
|
2024
|
|
|
6,494,479
|
|
2025
|
|
|
12,985,677
|
|
2026
|
|
|
12,339,131
|
|
2027
|
|
|
21,451,150
|
|
Recent
Accounting Pronouncements
The adoption of
Staff
Accounting Bulletin
No.
1
10
,
“
Share-based
payments
”
during fiscal 2007 did not have a
material impact on
our
results of operations and financial
position
.
In
September 2006, FASB issued Statement No. 157, “Fair Value Measurements” (“SFAS
No. 157”). SFAS No. 157 defines fair value, establishes a framework and gives
guidance regarding the methods used for measuring fair value, and expands
disclosures about fair value measurements. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning on or after November 15,
2007 and for interim periods within those fiscal years.
On
February 12, 2008, FASB issued FASB Staff Position No. 157-2, “Effective Date of
FASB Statement No 157” (FSP No. 157”). FSP No. 157-2 amends SFAS No. 157 to
delay the effective date of SFAS No. 157 for non-financial assets and
non-financial liabilities, except for items that are recognized or disclosed at
fair value in the financial statements on a recurring basis (at least annually)
for fiscal years beginning after November 15, 2008.
On
February 14, 2008, FASB issued FSP No. 157-1, “Application of FASB Statement No.
157 to FASB Statement No. 13 and Other Accounting Pronouncements that Address
Fair Value Measurements for Purposes of Lease Classification or Measurement
under Statement 13” (“FSP No. 157-1”). FSP No. 157-1 amends SFAS No.
157 to exclude SFAS No. 13, “Accounting for Leases” (“SFAS No. 13”), and other
accounting pronouncements that address fair value measurements for purposes of
lease classification or measurement under SFAS No. 13.
We are
currently evaluating the impact that the adoption of SFAS No. 157, FSP No. 157-2
and FSP No. 157-1 will have on our results of operations and financial
position.
In
February 2007, FASB issued Statement No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities—Including an amendment of FASB
Statement No. 115” (“SFAS No. 159”). SFAS No. 159 expands the use of fair value
accounting but does not affect existing standards which require assets or
liabilities to be carried at fair value. Under SFAS No. 159, a company may elect
to use fair value to measure accounts and loans receivable, available-for-sale
and held-to-maturity securities, equity method investments, accounts payable,
guarantees and issued debt. Other eligible items include firm commitments for
financial instruments that otherwise would not be recognized at inception and
non-cash warranty obligations where a warrantor is permitted to pay a third
party to provide the warranty goods or services. If the use of fair value is
elected, any upfront costs and fees related to the item must be recognized in
earnings and cannot be deferred (e.g., debt issue costs). The fair value
election is irrevocable and generally made on an instrument-by-instrument basis,
even if a company has similar instruments that it elects not to measure based on
fair value. At the adoption date, unrealized gains and losses on existing items
for which fair value has been elected are reported as a cumulative adjustment to
beginning retained earnings. Subsequent to the adoption of SFAS No. 159, changes
in fair value are recognized in earnings. SFAS No. 159 is effective for fiscal
years beginning on or after November 15, 2007 and is required to be adopted by
the Company in the first quarter of fiscal 2008. The adoption of SFAS No. 159
will not have a material impact on our results of operations and financial
position.
In June
2007, FASB’s Emerging Issues Task Force (“EITF”) issued EITF Issue No. 06-11,
“Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards”
(“EITF No. 06-11”). EITF No. 06-11 requires that the tax benefits related to
dividend equivalents paid on restricted stock units, which are expected to vest,
be recorded as an increase to additional paid-in capital. EITF No. 06-11 is
effective prospectively to the income tax benefits on dividends declared in
fiscal years beginning on or after December 15, 2007. We are currently
evaluating the impact the adoption of EITF No. 06-11 will have on our results of
operations and financial position.
In
December 2007, FASB issued Statement No. 141R (revised 2007), “Business
Combinations (a revision of Statement No. 141)” (“SFAS No. 141R”). SFAS No. 141R
applies to all transactions or other events in which an entity obtains control
of one or more businesses, including those business combinations achieved
without the transfer of consideration. SFAS No. 141R retains the fundamental
requirements in Statement No. 141 that the acquisition method of accounting be
used for all business combinations. SFAS No. 141R expands the scope to include
all business combinations and requires an acquirer to recognize the assets
acquired, the liabilities assumed, and any non-controlling interest in the
acquiree at their fair values as of the acquisition date. In addition, SFAS No.
141R changes the way entities account for business combinations achieved in
stages by requiring the identifiable assets and liabilities to be measured at
their full fair values. Also, contractual contingencies and contingent
consideration shall be measured at fair value at the acquisition date. SFAS No.
141R is effective on a prospective basis to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. We are currently evaluating the
impact, if any, that the adoption of SFAS No. 141R will have on our results of
operations and financial position.
In
December 2007, FASB issued Statement No. 160, “Noncontrolling Interests in
Consolidated Financial Statements - an amendment of ARB No. 51” (“SFAS No.
160”). SFAS No. 160 amends ARB No. 51 to establish accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. SFAS No. 160 clarifies that a non-controlling
interest in a subsidiary is an ownership interest in the consolidated entity
that should be reported as equity in the consolidated financial statements.
Additionally, SFAS No. 160 requires that consolidated net income include the
amounts attributable to both the parent and the non-controlling interest. SFAS
No. 160 is effective for interim periods beginning on or after December 15,
2008. We are currently evaluating the impact, if any, that the adoption of SFAS
No. 160 will have on our results of operations and financial
position.
ITEM
7A.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Quantitative
and Qualitative Disclosure of Market Risk
Currency
Fluctuations and Exchange Risk
All of
our sales are in U.S. dollars or are linked to the U.S. dollar, while a portion
of our expenses are in Canadian dollars and Euros. We cannot predict any future
trends in the exchange rate of the Canadian dollar or Euro against the U.S.
dollar. Any strengthening of the Canadian dollar or Euro in relation to the U.S.
dollar would increase the U.S. dollar cost of our operations, and affect our
U.S. dollar measured results of operations. We do not engage in any hedging or
other transactions intended to manage these risks. In the future, we may
undertake hedging or other similar transactions or invest in market risk
sensitive instruments if we determine that is advisable to offset these
risks.
Interest
Rate Risk
The
primary objective of our investment activity is to preserve principal while
maximizing interest income we receive from our investments, without increasing
risk. We believe this will minimize our market risk.
As at
December 31, 2007, we had investments in the aggregate principal amount of
$1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at a future date with an average maturity of
46 days. Due to the current lack of liquidity for asset-backed
securities of this type, the Company has concluded that the carrying value of
these investments was higher than its fair value as of December 31, 2007.
Accordingly, these auction rate securities have been recorded at their estimated
fair value of $863,750. We consider this to be an other-than-temporary reduction
in the value. Accordingly, the loss associated with these auction rate
securities of $1,036,250 has been included as an impairment of investments in
the Company's consolidated statement of operations for the year ended December
31, 2007. Although we continue to receive payment of interest earned on these
securities, we do not know at the present time when we will be able to convert
these investments into cash. Accordingly, management has classified
these investments as a non-current asset on its consolidated balance sheet as of
December 31, 2007. We will continue to closely monitor these investments for
future indications of further impairment. The illiquidity of these investments
may have an adverse impact on the length of time during which we currently
expect to be able to sustain our operations in the absence of an additional
capital raise by the Company.
ITEM
8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA.
|
Consolidated
Financial Statements
December
31, 2007 and 2006
REPORT
OF
INDEPENDENT REGISTERED
PUBLIC
ACCOUNTING FIRM
To the
Board of Directors and Shareholders of
OccuLogix, Inc.
We have
audited the accompanying consolidated balance sheets of
OccuLogix, Inc.
(the
“Company”) as of December 31, 2007 and 2006 and the related consolidated
statements of operations, changes in stockholders’ equity and cash flows for
each of the three years in the period ended December 31, 2007. Our
audits also included the financial statement schedule listed in the index at
Item 15(a). These financial statements and schedule are the responsibility
of the Company's management. Our responsibility is to
express an opinion on these financial statements and schedule based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of the Company as of
December 31, 2007 and 2006 and the consolidated result of its operations and its
cash flows for each of the three years in the period ended December 31, 2007 in
conformity with U.S. generally accepted accounting principles. Also, in our
opinion, the related financial statement schedule, when considered in relation
to the consolidated financial statements taken as a whole, presents fairly, in
all material respects, the information set forth therein.
Our
previous audit report dated March 14, 2008, has been withdrawn, and the
consolidated balance sheets as at December 31, 2007 and 2006 and the related
consolidated statements of operations, changes in stockholders’ equity and cash
flows for the years then ended have been restated, as described in note 2(a) to
the consolidated financial statements.
The
accompanying consolidated financial statements have been prepared assuming that
OccuLogix, Inc.
will
continue as a going concern. As more fully described in Note 1, the
Company has incurred recurring operating losses and has a working capital
deficiency. These conditions raise substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard
to these matters also are described in Note 1. The financial
statements do not include any adjustments to reflect the possible future effects
on the recoverability and classification of assets or the amounts and
classification of liabilities that may result from the outcome of this
uncertainty.
As
discussed in Note 3 to these consolidated financial statements, the Company
changed its accounting policy in regards to the accounting for income taxes for
the year ended December 31, 2007. Additionally, as discussed in Note 17(e), the
Company changed its accounting policy in regards to the accounting for
stock-based compensation during the year ended December 31, 2006.
We have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the effectiveness of
OccuLogix, Inc.’s
internal
control over financial reporting as of December 31, 2007, based on criteria
established in Internal Control – Integrated Framework issued by the Committee
of Sponsoring Organizations of the Treadway Commission, and our report dated
March 14, 2008 (except for the material weakness described in the sixth
paragraph of that report, as to which the date is July 18, 2008) expressed an
adverse opinion on the effectiveness of internal control over financial
reporting.
Toronto,
Canada,
|
/s/
Ernst & Young LLP
|
March
14, 2008 (except for note 2A,
|
Chartered
Accountants
|
as
to which the date is July 18, 2008).
|
Licensed
Public Accountants
|
CONSOLIDATED
BALANCE SHEETS
(expressed
in U.S. dollars)
(Going
Concern Uncertainty – See Note 1)
|
|
As
of December 31,
|
|
|
|
|
2007
$
|
|
|
|
2006
$
|
|
|
As
restated
Note
2
|
|
|
As
restated
Notes
2 and 10
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
2,235,832
|
|
|
|
5,705,235
|
|
Short-term
investments
|
|
|
—
|
|
|
|
9,785,000
|
|
Amounts
receivable, net of bad debt reserves of $172,992 in 2007 and nil in 2006
(note
12(e))
|
|
|
374,815
|
|
|
|
165,409
|
|
Inventory,
net of provision for inventory obsolescence of $7,295,545 in
2007 and $5,101,394 in 2006
|
|
|
—
|
|
|
|
2,344,638
|
|
Prepaid
expenses
|
|
|
481,121
|
|
|
|
548,883
|
|
Other
current assets
|
|
|
10,442
|
|
|
|
10,442
|
|
Current
assets relating to discontinued operations
(note
10)
|
|
|
—
|
|
|
|
618,154
|
|
Total current
assets
|
|
|
3,102,210
|
|
|
|
19,177,761
|
|
Fixed
assets, net
(note
6)
|
|
|
122,286
|
|
|
|
574,310
|
|
Patents
and trademarks, net
(note
7)
|
|
|
139,437
|
|
|
|
234,841
|
|
Investments
(note
1)
|
|
|
863,750
|
|
|
|
—
|
|
Intangible
assets, net
(note
8)
|
|
|
11,085,054
|
|
|
|
34,998,455
|
|
Goodwill
(note
5)
|
|
|
—
|
|
|
|
—
|
|
Other
assets relating to discontinued operations
(note
10)
|
|
|
—
|
|
|
|
43,540,051
|
|
|
|
|
15,312,737
|
|
|
|
98,525,418
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Accounts
payable
(note
12)
|
|
|
1,192,807
|
|
|
|
162,705
|
|
Accrued
liabilities
(notes 12
and 14)
|
|
|
2,873,451
|
|
|
|
1,837,158
|
|
Due
to stockholders
(note
11)
|
|
|
32,814
|
|
|
|
152,406
|
|
Current
portion of other long-term liability
(note
4)
|
|
|
—
|
|
|
|
3,000,000
|
|
Current
liabilities relating to discontinued operations
(note
10)
|
|
|
—
|
|
|
|
486,466
|
|
Total
current liabilities
|
|
|
4,099,072
|
|
|
|
5,638,735
|
|
Deferred
tax liability, net
(note
13)
|
|
|
2,259,348
|
|
|
|
11,100,356
|
|
Other
long-term liability
(note
4)
|
|
|
—
|
|
|
|
3,420,609
|
|
Other
liabilities relating to discontinued operations
(note
10)
|
|
|
—
|
|
|
|
11,087,750
|
|
Total
liabilities
|
|
|
6,358,420
|
|
|
|
31,247,450
|
|
Commitments
and contingencies
(note
16)
|
|
|
|
|
|
|
|
|
Minority
interest
|
|
|
4,953,960
|
|
|
|
6,110,834
|
|
Stockholders’
equity
|
|
|
|
|
|
|
|
|
Capital
stock
(note
17)
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
57,306
|
|
|
|
50,627
|
|
Par
value of $0.001 per share;
|
|
|
|
|
|
|
|
|
Authorized:
75,000,000; Issued and outstanding:
|
|
|
|
|
|
|
|
|
December
31, 2007 – 57,306,145; December 31, 2006 – 50,626,562
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
362,232,031
|
|
|
|
354,175,504
|
|
Accumulated
deficit
|
|
|
(358,288,980
|
)
|
|
|
(293,058,997
|
)
|
Total
stockholders’ equity
|
|
|
4,000,357
|
|
|
|
61,167,134
|
|
|
|
|
15,312,737
|
|
|
|
98,525,418
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
(expressed
in U.S. dollars except number of shares)
|
|
Years
ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
As
restated
Note
2
|
|
|
As
restated
Notes
2 and 10
|
|
|
As restated
Note
10
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
to related parties
(note
12)
|
|
|
—
|
|
|
|
—
|
|
|
|
81,593
|
|
Sales
to unrelated parties
|
|
|
91,500
|
|
|
|
174,259
|
|
|
|
1,758,696
|
|
Total
revenue
|
|
|
91,500
|
|
|
|
174,259
|
|
|
|
1,840,289
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold to related parties
(note
12)
|
|
|
—
|
|
|
|
—
|
|
|
|
43,236
|
|
Cost
of goods sold to unrelated parties
|
|
|
2,298,103
|
|
|
|
3,428,951
|
|
|
|
3,250,866
|
|
Royalty
costs
|
|
|
100,000
|
|
|
|
100,000
|
|
|
|
100,000
|
|
Total
cost of goods sold
|
|
|
2,398,103
|
|
|
|
3,528,951
|
|
|
|
3,394,102
|
|
|
|
|
(2,306,603
|
)
|
|
|
(3,354,692
|
)
|
|
|
(1,553,813
|
)
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
(notes 11, 12 and
17)
|
|
|
8,104,405
|
|
|
|
8,475,751
|
|
|
|
8,670,394
|
|
Clinical
and regulatory
(notes 12
and 17)
|
|
|
8,675,552
|
|
|
|
4,921,771
|
|
|
|
5,167,549
|
|
Sales
and marketing
(notes 12
and 17)
|
|
|
1,413,459
|
|
|
|
1,625,187
|
|
|
|
2,165,337
|
|
Impairment
of goodwill
(note
5)
|
|
|
—
|
|
|
|
65,945,686
|
|
|
|
147,451,758
|
|
Impairment
of intangible asset
(note
8)
|
|
|
20,923,028
|
|
|
|
—
|
|
|
|
—
|
|
Restructuring
charges
(note
9)
|
|
|
1,312,721
|
|
|
|
819,642
|
|
|
|
—
|
|
|
|
|
40,429,165
|
|
|
|
81,788,037
|
|
|
|
163,455,038
|
|
Loss
from continuing operations
|
|
|
(42,735,768
|
)
|
|
|
(85,142,729
|
)
|
|
|
(165,008,851
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
609,933
|
|
|
|
1,370,208
|
|
|
|
1,593,366
|
|
Changes
in fair value of warrant obligation
(note
17(f))
|
|
|
1,882,497
|
|
|
|
—
|
|
|
|
—
|
|
Impairment
of investments
(note
1)
|
|
|
(1,036,250
|
)
|
|
|
—
|
|
|
|
—
|
|
Interest
expense
|
|
|
(17,228
|
)
|
|
|
(14,896
|
)
|
|
|
—
|
|
Other,
net
|
|
|
18,011
|
|
|
|
30,935
|
|
|
|
(57,025
|
)
|
Minority
interest
|
|
|
1,312,178
|
|
|
|
161,179
|
|
|
|
—
|
|
|
|
|
2,769,141
|
|
|
|
1,547,426
|
|
|
|
1,536,341
|
|
Loss
from continuing operations before income taxes
|
|
|
(39,966,627
|
)
|
|
|
(83,595,303
|
)
|
|
|
(163,472,510
|
)
|
Recovery
of income taxes
(note
13)
|
|
|
5,565,542
|
|
|
|
2,915,790
|
|
|
|
642,529
|
|
Loss
from continuing operations
|
|
|
(34,401,085
|
)
|
|
|
(80,679,513
|
)
|
|
|
(162,829,981
|
)
|
Loss
from discontinued operations
(note
10)
|
|
|
(35,428,898
|
)
|
|
|
(1,542,384
|
)
|
|
|
—
|
|
Net
loss for the year
|
|
|
(69,829,983
|
)
|
|
|
(82,221,897
|
)
|
|
|
(162,829,981
|
)
|
Weighted
average number of shares outstanding – basic and diluted
|
|
|
56,628,186
|
|
|
|
44,979,692
|
|
|
|
41,931,240
|
|
Loss
from continuing operations per share – basic and diluted
|
|
$
|
(0.60
|
)
|
|
$
|
(1.79
|
)
|
|
$
|
(3.88
|
)
|
Loss
from discontinued operations per share – basic and diluted
|
|
|
(0.63
|
)
|
|
|
(0.04
|
)
|
|
|
—
|
|
Net
loss per share – basic and diluted
|
|
$
|
(1.23
|
)
|
|
$
|
(1.83
|
)
|
|
$
|
(3.88
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(expressed
in U.S. dollars)
As
restated - Note 2
|
|
Voting
common
stock
at
par value
|
|
|
Additional
paid-in
capital
|
|
|
Accumulated
deficit
|
|
|
Accumulated
other comprehensive loss
|
|
|
Stockholders’
equity
|
|
|
|
shares
issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
#
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2004
|
|
|
41,806,768
|
|
|
|
41,807
|
|
|
|
336,063,557
|
|
|
|
(48,007,119
|
)
|
|
|
—
|
|
|
|
288,098,245
|
|
Stock-based
compensation
(note
17(e))
|
|
|
—
|
|
|
|
—
|
|
|
|
224,776
|
|
|
|
—
|
|
|
|
—
|
|
|
|
224,776
|
|
Stock
issued on exercise of options
(note
17(e))
|
|
|
279,085
|
|
|
|
279
|
|
|
|
230,956
|
|
|
|
—
|
|
|
|
—
|
|
|
|
231,235
|
|
Subscription
receivable
|
|
|
—
|
|
|
|
—
|
|
|
|
221,661
|
|
|
|
—
|
|
|
|
—
|
|
|
|
221,661
|
|
Contribution
of inventory from related party
(note
12)
|
|
|
—
|
|
|
|
—
|
|
|
|
167,730
|
|
|
|
—
|
|
|
|
—
|
|
|
|
167,730
|
|
Contribution
of inventory from unrelated party
|
|
|
—
|
|
|
|
—
|
|
|
|
15,652
|
|
|
|
—
|
|
|
|
—
|
|
|
|
15,652
|
|
Fractional
payout of converted shares due to preferred stockholders
|
|
|
—
|
|
|
|
—
|
|
|
|
(45
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(45
|
)
|
Additional
share issue costs related to initial public offering
(note
17(d))
|
|
|
—
|
|
|
|
—
|
|
|
|
(88,714
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(88,714
|
)
|
Net
loss for the year
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(162,829,981
|
)
|
|
|
—
|
|
|
|
(162,829,981
|
)
|
Balance,
December 31, 2005
|
|
|
42,085,853
|
|
|
|
42,086
|
|
|
|
336,835,573
|
|
|
|
(210,837,100
|
)
|
|
|
—
|
|
|
|
126,040,559
|
|
Stock-based
compensation
(note
17(e))
|
|
|
—
|
|
|
|
—
|
|
|
|
2,111,481
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,111,481
|
|
Stock
issued on exercise of options
(note
17(e))
|
|
|
140,726
|
|
|
|
141
|
|
|
|
270,794
|
|
|
|
—
|
|
|
|
—
|
|
|
|
270,935
|
|
Free
inventory returned to related party
(note
12)
|
|
|
—
|
|
|
|
—
|
|
|
|
(60,000
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(60,000
|
)
|
Contribution
of inventory from unrelated party
|
|
|
—
|
|
|
|
—
|
|
|
|
11,994
|
|
|
|
—
|
|
|
|
—
|
|
|
|
11,994
|
|
Shares
issued on acquisition of Solx, Inc.
(notes 4 and
17(d))
|
|
|
8,399,983
|
|
|
|
8,400
|
|
|
|
15,027,570
|
|
|
|
—
|
|
|
|
—
|
|
|
|
15,035,970
|
|
Shares
issue costs
|
|
|
—
|
|
|
|
—
|
|
|
|
(21,908
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(21,908
|
)
|
Net
loss for the year
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(82,221,897
|
)
|
|
|
—
|
|
|
|
(82,221,897
|
)
|
Balance,
December 31, 2006
|
|
|
50,626,562
|
|
|
|
50,627
|
|
|
|
354,175,504
|
|
|
|
(293,058,997
|
)
|
|
|
—
|
|
|
|
61,167,134
|
|
OccuLogix,
Inc.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY continued
(expressed
in U.S. dollars)
As
restated - Note 2
|
|
Voting
common
stock
at
par value
|
|
|
Additional
paid-in
capital
|
|
|
Accumulated
deficit
|
|
|
Accumulated
other comprehensive loss
|
|
|
Stockholders’
equity
|
|
|
|
shares
issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
#
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Balance,
December 31, 2006 (balance forward)
|
|
|
50,626,562
|
|
|
|
50,627
|
|
|
|
354,175,504
|
|
|
|
(293,058,997
|
)
|
|
|
—
|
|
|
|
61,167,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(69,829,983
|
)
|
|
|
—
|
|
|
|
(69,829,983
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
loss on investments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,036,250
|
)
|
|
|
(1,036,250
|
)
|
Impairment
of investments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,036,250
|
|
|
|
1,036,250
|
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(69,829,983
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
effect of adoption of
FIN 48 (note
13)
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,600,000
|
|
|
|
—
|
|
|
|
4,600,000
|
|
Stock-based
compensation
(note
17(e))
|
|
|
—
|
|
|
|
—
|
|
|
|
325,666
|
|
|
|
—
|
|
|
|
—
|
|
|
|
325,666
|
|
Stock
issued on exercise of options
(note
17(e))
|
|
|
2,250
|
|
|
|
2
|
|
|
|
2,226
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,228
|
|
Contribution
of inventory from related party
(note
12)
|
|
|
—
|
|
|
|
—
|
|
|
|
384,660
|
|
|
|
—
|
|
|
|
—
|
|
|
|
384,660
|
|
Contribution
of inventory from unrelated party
|
|
|
—
|
|
|
|
—
|
|
|
|
33,643
|
|
|
|
—
|
|
|
|
—
|
|
|
|
33,643
|
|
Shares
issued on private placement of common stock
(note
17(d))
|
|
|
6,677,333
|
|
|
|
6,677
|
|
|
|
8,053,967
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,060,644
|
|
Shares
issue costs
|
|
|
—
|
|
|
|
—
|
|
|
|
(743,635
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(743,635
|
)
|
Balance,
December 31, 2007
|
|
|
57,306,145
|
|
|
|
57,306
|
|
|
|
362,232,031
|
|
|
|
(358,288,980
|
)
|
|
|
—
|
|
|
|
4,000,357
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(expressed
in U.S. dollars)
|
|
Years
ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
As
restated
Note
2
|
|
|
As
restated Notes 2 and 10
|
|
|
As
restated Note 10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year
|
|
|
(69,829,983
|
)
|
|
|
(82,221,897
|
)
|
|
|
(162,829,981
|
)
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
(note
17(e))
|
|
|
480,971
|
|
|
|
2,127,043
|
|
|
|
224,776
|
|
Amortization
of fixed assets
|
|
|
844,948
|
|
|
|
213,488
|
|
|
|
99,301
|
|
Amortization
of patents and trademarks
|
|
|
195,494
|
|
|
|
5,608
|
|
|
|
5,712
|
|
Amortization
of intangible assets
|
|
|
5,308,706
|
|
|
|
2,817,462
|
|
|
|
1,716,667
|
|
Impairment
of goodwill
(note
5)
|
|
|
14,446,977
|
|
|
|
65,945,686
|
|
|
|
147,451,758
|
|
Impairment
of intangible assets
(note
8)
|
|
|
43,209,411
|
|
|
|
—
|
|
|
|
—
|
|
Accretion
expense
(note
4)
|
|
|
857,400
|
|
|
|
273,195
|
|
|
|
—
|
|
Amortization
of premiums/discounts on short-term investments
|
|
|
—
|
|
|
|
35,985
|
|
|
|
147,337
|
|
Subscription
receivable – provision for doubtful amount
|
|
|
—
|
|
|
|
—
|
|
|
|
34,927
|
|
Change
in fair value of warrant obligation
(note
17(f))
|
|
|
(1,882,497
|
)
|
|
|
—
|
|
|
|
—
|
|
Impairment
of investments
|
|
|
1,036,250
|
|
|
|
—
|
|
|
|
—
|
|
Deferred
income taxes
(note
13)
|
|
|
(14,915,425
|
)
|
|
|
(4,093,262
|
)
|
|
|
(635,167
|
)
|
Minority
interest
|
|
|
(1,312,178
|
)
|
|
|
(161,179
|
)
|
|
|
—
|
|
Net
change in non-cash working capital balances related to operations
(note
18)
|
|
|
4,342,488
|
|
|
|
509,528
|
|
|
|
(4,925,650
|
)
|
Cash
used in operating activities
|
|
|
(17,217,438
|
)
|
|
|
(14,548,344
|
)
|
|
|
(18,710,320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of short-term investments
|
|
|
7,885,000
|
|
|
|
21,841,860
|
|
|
|
10,689,818
|
|
Additions
to fixed assets
|
|
|
(267,934
|
)
|
|
|
(255,886
|
)
|
|
|
(202,273
|
)
|
Additions
to patents and trademarks
|
|
|
(106,228
|
)
|
|
|
(105,217
|
)
|
|
|
(36,290
|
)
|
Acquisition
costs
(note
4)
|
|
|
—
|
|
|
|
(949,499
|
)
|
|
|
—
|
|
Advance
to Solx, Inc., pre-acquisition
|
|
|
—
|
|
|
|
(2,434,537
|
)
|
|
|
—
|
|
Payments
for acquisitions, net of cash acquired
(note
4)
|
|
|
(3,000,000
|
)
|
|
|
(7,678,565
|
)
|
|
|
—
|
|
Cash
provided by investing activities
|
|
|
4,510,838
|
|
|
|
10,418,156
|
|
|
|
10,451,255
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from exercise of common stock options
(note
17(e))
|
|
|
2,228
|
|
|
|
270,935
|
|
|
|
231,235
|
|
Proceeds
from exercise of Series A convertible preferred stock warrants
(note
17(f))
|
|
|
—
|
|
|
|
—
|
|
|
|
186,734
|
|
Fractional
payout of converted shares due to preferred stockholders
|
|
|
—
|
|
|
|
—
|
|
|
|
(792
|
)
|
Share
issuance costs
|
|
|
(816,493
|
)
|
|
|
—
|
|
|
|
(88,714
|
)
|
Proceeds
from issuance of common stock
(note
17(d))
|
|
|
10,016,000
|
|
|
|
—
|
|
|
|
—
|
|
Cash
provided by financing activities
|
|
|
9,201,735
|
|
|
|
270,935
|
|
|
|
328,463
|
|
Net
decrease in cash and cash equivalents during the year
|
|
|
(3,504,865
|
)
|
|
|
(3,859,253
|
)
|
|
|
(7,930,602
|
)
|
Cash
and cash equivalents, beginning of year
|
|
|
5,740,697
|
|
|
|
9,599,950
|
|
|
|
17,530,552
|
|
Cash
and cash equivalents, end of year
|
|
|
2,235,832
|
|
|
|
5,740,697
|
(i)
|
|
|
9,599,950
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes
|
|
|
|
|
|
|
|
|
|
|
|
|
(i)
|
As
at December 31, 2006, cash and cash equivalents of $5,740,697 include cash
and cash equivalents of discontinued operations of
$35,462.
|
Notes
to Consolidated Financial Statements
(expressed
in U.S. dollars except as otherwise noted)
1.
NATURE OF OPERATIONS AND GOING CONCERN UNCERTAINTY
OccuLogix,
Inc. (“OccuLogix” or the “Company”) is an ophthalmic therapeutic company founded
to commercialize innovative treatments for age-related eye diseases. Until
recently, the Company operated two business divisions, being Retina and
Glaucoma. Until recently, the Company’s Retina division was in the business of
developing and commercializing a treatment for dry age-related macular
degeneration, or Dry AMD. The Company’s product for Dry AMD, the RHEO™ System,
contains a pump that circulates blood through two filters and is used to perform
the Rheopheresis™ procedure, which is referred to under the Company’s trade name
RHEO™ Therapy. The Rheopheresis™ procedure is a blood filtration procedure that
selectively removes molecules from plasma, which is designed to treat Dry AMD,
the most common form of the disease.
The Company
conducted a clinical trial, called MIRA-1, or Multicenter Investigation of
Rheopheresis for AMD, which, if successful, was expected to support its
application with the U.S. Food and Drug Administration (the “FDA”) to obtain
approval to market the RHEO™ System in the United States. On February 3, 2006,
the Company announced that, based on a preliminary analysis of the data from
MIRA-1, MIRA-1 did not meet its primary efficacy endpoint as it did not
demonstrate a statistically significant difference in the mean change of Best
Spectacle-Corrected Visual Acuity applying the Early Treatment Diabetic
Retinopathy Scale, or ETDRS BCVA, between the treated and placebo groups in
MIRA-1 at 12 months post-baseline. As expected, the treated group demonstrated a
positive result. An anomalous response of the control group is the principal
reason why the primary efficacy endpoint was not met.
On
June 8, 2006, the Company met with the FDA to discuss the results of MIRA-1 and
the impact the results will have on its application to market the RHEO™ System
in the United States. In light of MIRA-1’s failure to meet its
primary efficacy endpoint, the FDA advised that it will require an additional
study of the RHEO™ System to be performed. On January 29, 2007, the Company
announced that it had obtained Investigational Device Exemption clearance from
the FDA to commence the new pivotal clinical trial of the RHEO™ System called
RHEO-AMD, or Safety and Effectiveness in a Multi-Center, Randomized,
Sham-Controlled Investigation for Dry Non-exudative Age-Related Macular
Degeneration (AMD) using Rheopheresis.
However,
on November 1, 2007, the Company announced the indefinite suspension of its
RHEO™ System clinical development program. This decision was made following a
comprehensive review of the respective costs and development timelines
associated with the products in the Company’s portfolio and in light of the
Company’s financial position. The Company is in the process of winding down the
RHEO-AMD study as there is no reasonable prospect that the RHEO™ System clinical
development program will be relaunched in the foreseeable future. Subsequent to
the Company’s fiscal 2007 year-end, as of February 25, 2008, the Company has
terminated its relationship with Asahi Kasei Kuraray Medical Co., Ltd. (formerly
Asahi Kasei Medical Co., Ltd.), or Asahi Medical. Asahi Medical manufactures and
supplied the Company with the Rheofilter filter and the Plasmaflo filter, both
of which are key components of the RHEO™ System. The Company is also engaged in
discussions with Diamed Medizintechnik GmbH, or Diamed, and MeSys GmbH, or
MeSys, regarding the termination of its relationship with each of
them. Diamed is the designer, and MeSys is the manufacturer, of the
OctoNova pump, another key component of the RHEO™ System.
In
anticipation of the delay in the commercialization of the RHEO™ System in the
United States as a result of the MIRA-1 study’s failure to meet its primary
efficacy endpoint and the FDA’s requirement of the Company to conduct an
additional study of the RHEO™ System, the Company accelerated its
diversification plans and, on September 1, 2006, acquired Solx, Inc., or SOLX, a
Boston University Photonics Center-incubated company that has developed a system
for the treatment of glaucoma, called the SOLX Glaucoma System.
The
SOLX Glaucoma System developed by SOLX
includes the SOLX 790 Titanium Sapphire Laser (“SOLX 790 Laser”) and the
SOLX Gold Shunt which
can
be used separately or together to provide physicians with multiple options to
manage intraocular pressure, or IOP
(note 4)
. Upon the acquisition of SOLX, SOLX
became the Glaucoma division of the Company.
On
December 20, 2007, the Company announced the sale of all of the issued and
outstanding capital stock of SOLX to Solx Acquisition, Inc., or Solx
Acquisition, a company wholly owned by Doug P. Adams, the founder of SOLX and
who, until the closing of the sale, had been serving as an executive officer of
the Company in the capacity of President & Founder, Glaucoma Division. The
consideration for the purchase and sale of all of the issued and outstanding
shares of the capital stock of SOLX consisted of: (i) on December 19,
2007, the closing date of the sale, the assumption by Solx Acquisition of all of
the liabilities of the Company, as they related to SOLX’s business, incurred on
or after December 1, 2007, and the Company’s obligation to make a $5,000,000
payment to the former stockholders of SOLX due on September 1, 2008 in
satisfaction of the outstanding balance of the purchase price of SOLX; (ii) on
or prior to February 15, 2008, the payment by Solx Acquisition of all of the
expenses that the Company had paid to the closing date, as they related to
SOLX’s business during the period commencing on December 1, 2007; (iii) during
the period commencing on the closing date and ending on the date on which SOLX
achieves a positive cash flow, the payment by Solx Acquisition of a royalty
equal to 3% of the worldwide net sales of the SOLX 790 Laser and the SOLX Gold
Shunt, including next-generation or future models or versions of these products;
and (iv) following the date on which SOLX achieves a positive cash flow, the
payment by Solx Acquisition of a royalty equal to 5% of the worldwide net sales
of these products. In order to secure the obligation of Solx Acquisition to make
these royalty payments, SOLX granted to the Company a subordinated security
interest in certain of its intellectual property. In connection with the sale of
SOLX, those employees of the Company, whose roles and responsibilities related
mainly to SOLX’s business, ceased to be employees of the Company and became
employees of Solx Acquisition or SOLX.
As part
of its accelerated diversification plans, on November 30, 2006, the Company
acquired 50.1% of the capital stock, on a fully diluted basis, 57.62% on an
issued and outstanding basis, of OcuSense, Inc., or OcuSense, a San Diego-based
company that is in the process of developing technologies that will enable eye
care practitioners to test, at the point-of-care, for highly sensitive and
specific biomarkers using nanoliters of tear film
(note 4)
.
With the
suspension of the Company’s RHEO™ System clinical development program, and the
consequent winding-down of the RHEO-AMD study, and the Company’s disposition of
SOLX, the Company no longer has any operating business. Its major asset is its
50.1% ownership stake, on a fully diluted basis, in OcuSense.
Going
concern uncertainty
The
consolidated financial statements have been prepared on the basis that the
Company will continue as a going concern. However, the Company has sustained
substantial losses of $69,829,983, $82,221,897 and $162,829,981 for the years
ended December 31, 2007, 2006 and 2005, respectively. The Company’s working
capital deficiency at December 31, 2007 is $996,862, which represents a
$14,535,888 reduction of its working capital of $13,539,026 at December 31,
2006. As a result of the Company’s history of losses and financial condition,
there is substantial doubt about the ability of the Company to continue as a
going concern.
On
February 19, 2008, the Company announced that it has secured a bridge loan in an
aggregate principal amount of $3,000,000 (less transaction costs of
approximately $200,000) from a number of private parties. The loan bears
interest at a rate of 12% per annum and has a 180-day term, which may be
extended to 270 days under certain circumstances. The Company has pledged its
shares of the capital stock of OcuSense as collateral for the loan.
Management
believes that these proceeds, together with the Company’s existing cash, will be
sufficient to cover its operating activities and other demands only until
approximately the end of April 2008
(assuming that the outstanding
obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due and payable
prior to the end of April 2008)
(note
4)
. The Company currently is not generating cash from
operations, and most of its cash has been, and is being, utilized to fund its
operations and to fund deferred acquisition payments. The Company’s operating
expenses have consisted mostly of expenses relating to the furtherance of its
clinical trial activities, the commercialization of the SOLX Glaucoma System in
Europe and the completion of the product development of the TearLab™ test for
dry eye disease, or DED. Unless the Company raises additional
capital, it will not have sufficient cash to support its operations beyond
approximately the end of April 2008.
On
October 9, 2007, the Company announced that its Board of Directors, or the Board
(note 17(e)), had authorized management and the Company’s advisors to explore
the full range of strategic alternatives available to enhance shareholder value.
These alternatives may include, but are not limited to, the raising of capital
through the sale of securities, one or more strategic alliances and the
combination, sale or merger of all or part of OccuLogix. In making the
announcement, the Company stated that there can be no assurance that the
exploration of strategic alternatives will result in a transaction. To date, the
Company has not disclosed, nor does it intend to disclose, developments with
respect to its exploration of strategic alternatives unless and until the Board
has approved a specific transaction.
For some
time prior to the October 9, 2007 announcement, the Company had been seeking to
raise additional capital, with the objective of securing funding sufficient to
sustain its operations as it had been clear that, unless the Company was able to
raise additional capital, the Company would not have had sufficient cash to
support its operations beyond early 2008. The Board’s decisions to suspend the
Company’s RHEO™ System clinical development program and to dispose of SOLX were
made and implemented in order to conserve as much cash as possible while the
Company continued its capital-raising efforts.
On
January 9, 2008, the Company announced the departure, or pending departure, of
seven members of its executive team and, commencing on February 1, 2008, a 50%
reduction in the salary of each of Elias Vamvakas, its Chairman and Chief
Executive Officer, and Tom Reeves, its President and Chief Operating Officer. By
January 31, 2008, a total of 12 non-executive employees of the Company had left
the Company’s employment.
As at
December 31, 2007, the Company had investments in the aggregate principal amount
of $1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at a future date with an average maturity of
46 days. Due to the current lack of liquidity for asset-backed
securities of this type, the Company has concluded that the carrying value of
these investments was higher than their fair value as of December 31, 2007.
Accordingly, these auction rate securities have been recorded at their estimated
fair value of $863,750. The Company considers this to be an other-than-temporary
reduction in the value. Accordingly, the loss associated with these auction rate
securities of $1,036,250 has been included as an impairment of investments in
the Company’s consolidated statement of operations for the year ended December
31, 2007. Although the Company continues to receive payment of interest earned
on these securities, the Company does not know at the present time when it will
be able to convert these investments into cash. Accordingly,
management has classified these investments as a non-current asset on its
consolidated balance sheet as of December 31, 2007. Management will continue to
closely monitor these investments for future indications of further impairment.
The illiquidity of these investments may have an adverse impact on the length of
time during which the Company currently expects to be able to sustain its
operations in the absence of an additional capital raise by the
Company.
The
consolidated financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or the amounts and
classification of liabilities that might be necessary if the Company were not
able to continue in existence as a going concern.
2. RESTATEMENT
OF CONSOLIDATED FINANCIAL STATEMENTS
A. Correction
of an error related to the method of consolidation of OcuSense Inc.
Background
Information
On
November 30, 2006, OccuLogix acquired 1,754,589 Series A preferred shares of
OcuSense. The purchase price of these shares was made up of two fixed payments
of $2.0 million each to be made on the date of the closing of the transaction
(i.e. November 30, 2006) and on January 3, 2007. In addition, subject
to OcuSense achieving certain milestones, the Company was required to pay two
additional milestone payments of $2.0 million each.
Upon
acquiring the Series A preferred shares, OccuLogix and the existing common
shareholders entered into a voting agreement. The voting agreement
provides the founding shareholders of OcuSense, as defined in the voting
agreement, with the right to appoint two board members and OccuLogix with the
right to also appoint two directors. A selection of a fifth director
is mutually agreed upon by both OccuLogix and the founding stockholders, each
voting as a separate class. The voting agreement is subject to
termination under the following scenarios: a) a change of control; b) majority
approval of each of OccuLogix and the founding stockholders; and c) conversion
of all outstanding shares of the Company’s preferred shares to common
shares. OccuLogix has the ability to force the conversion of all of
the preferred shares to common shares and thus has the ability to effect a
termination of the voting agreement, but this would require conversion of its
own preferred shares and the relinquishment of the rights and obligations
associated with the preferred shares.
The
rights and obligations of the Series A preferred shareholders are as
follows:
·
|
Voting
– Holders of the Series A preferred shares are entitled to vote on an
as-converted basis. Each Series A preferred share is entitled
to one vote per share.
|
·
|
Conversion
features – Series A preferred shares are convertible to common
shares on a one-for-one basis at the option of
OccuLogix.
|
·
|
Dividends
– The preferred shares are entitled to non-cumulative dividends at 8%, and
additional dividends would be shared between common and preferred shares
on a per-share basis.
|
·
|
Redemption
features – Subsequent to November 30, 2011, the preferred shares may be
redeemed at the option of OccuLogix, at the higher of the original issue
price and the fair market value of the common shares into which the
preferred shares could be
converted.
|
·
|
Liquidation
preferences – Series A preferred shares have a liquidation preference over
common shares up to the original issue price of the preferred shares
(including the milestone payments).
|
Immediately
after the OccuLogix investment in OcuSense, OcuSense had the following capital
structure:
Description
|
|
Number
|
|
Common
shares
|
|
|
1,222,979
|
|
Series
A preferred shares – OccuLogix
|
|
|
1,754,589
|
|
Series
A preferred shares – Other unrelated parties
|
|
|
67,317
|
|
Total
|
|
|
3,044,885
|
|
Potentially
dilutive instruments
|
|
|
|
|
Warrants
|
|
|
89,965
|
|
Stock
options
|
|
|
367,311
|
|
Fully
diluted
|
|
|
3,502,161
|
|
Based on
the above capital structure, on a fully diluted basis, OccuLogix’s voting
percentage was determined to be 50.1%. On a current voting basis,
OccuLogix’s voting interest is 57.62%. We previously consolidated OcuSense
based on an ownership percentage of 50.1%.
Interpretation and Related
Accounting Treatment
Since
November 30, 2006, the date of the acquisition, the Company has consolidated
OcuSense on the basis of a voting control model, as a result of the fact that it
owns more than 50% of the voting stock of OcuSense and that the Company has the
ability to convert its Series A preferred shares into common shares, which would
result in termination of the voting agreement between the founders and OccuLogix
and which would result in OccuLogix gaining control of the board of
directors.
However,
after further consideration, the Company has now determined that, as a result of
the voting agreement between OccuLogix and certain founding stockholders of
OcuSense, OccuLogix is not able to exercise voting control as contemplated in
ARB 51, “Consolidated Financial Statements” (“ARB 51”) unless the Company
converts its Series A preferred shares. For purpose of assessing
voting control in accordance with ARB 51, accounting principals generally
accepted in the United States (“U.S. GAAP”) do not take into consideration such
conversion rights. Accordingly OccuLogix does not have the ability to exercise
control of OcuSense, in light of the voting agreement that currently exists
between the founding stockholders and OccuLogix.
In
addition to the above consideration, the Company also determined that OcuSense
is a Variable Interest Entity and that OccuLogix is the primary beneficiary
based on the following:
·
|
OcuSense
is a development stage enterprise (as defined under FAS 7, “Accounting and
Reporting by Development Stage Enterprises”) and therefore is not
considered to be a business under U.S. GAAP. Accordingly,
OcuSense is not subject to the business scope
exception.
|
·
|
The
Company noted that the holders of the Series A preferred shares (including
OccuLogix) have the ability to redeem their shares at the greater of their
original subscription price and their fair value on an as-converted
basis. As such, their investment is not considered to be
at-risk equity.
|
·
|
Additionally,
as a result of the voting agreement between OccuLogix and the founding
stockholders of OcuSense, voting control of OcuSense is shared between
OccuLogix and OcuSense. Accordingly, the common stockholders,
who represent the sole class of at-risk equity, cannot make decisions
about an entity’s activities that have a significant effect on the success
of the entity without the concurrence of
OccuLogix.
|
FIN 46(R)
requires that the enterprise which consolidates the VIE be the primary
beneficiary of that entity. The primary beneficiary is the entity that will
absorb a majority of the VIE’s expected losses, receive a majority of the
entity’s expected returns, or both. At the time of acquisition, it was expected
that the Company would contribute virtually all of the required funding until
commercialization through the acquisition of the Series A preferred shares and
future milestone payments as described above. The common stockholders
were expected to make nominal equity contributions during this
period. Therefore, based primarily on qualitative considerations, the
Company believes that it is the primary beneficiary of OcuSense and should
consolidate OcuSense using the variable interest model.
The
Company has noted that the initial measurement of assets, liabilities and
non-controlling interests under FIN 46(R) differs from that which is required
under FAS 141, “Business Combinations”. In particular, under FIN
46(R), assets, liabilities and non-controlling interest shall be measured
initially at their fair value. The Company previously recorded non-controlling
interest based on the historical carrying values of OcuSense’s assets and
liabilities, and as a result consolidation under FIN 46(R) will result in
material revisions to the amounts previously reported in the Company’s
consolidated financial statements.
Assets
acquired and liabilities assumed consisted solely of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. Before consideration of deferred tax, the fair value of the
assets acquired was greater than the fair value of the liabilities assumed and
the non-controlling interest. Because OcuSense does not comprise a
business, as defined in Emerging Issues Task Force (“EITF”) 98-3, “Determining
Whether a Nonmonetary Transaction Involves Receipt of Productive Assets or of a
Business”, the Company applied the simultaneous equation method as
per EITF 98-11, “Accounting for Acquired Temporary Differences in Certain
Purchase Transactions That Are Not Accounted for as Business Combinations”, and
adjusted the assigned value of the non-monetary assets acquired (consisting
solely of the technology asset) to include the deferred tax
liability.
The
Company also considered the appropriate accounting for the milestone payments,
as a result of the fact that it has determined that it should apply the initial
measurement guidance in FIN 46(R). The Company notes that subsequent
to initial consolidation, the milestone payment liability represents a
contingent liability to a controlled subsidiary, and as such, the liability will
eliminate on consolidation. Previously, the Company adjusted the
minority interest at the date of each milestone payment to reflect the
non-controlling interest’s share in the additional cash of the subsidiary, with
an offsetting increase to the non-monetary assets acquired (consisting solely of
the technology intangible asset) reflecting the increased actual cost of
obtaining those non-monetary assets.
The
Company notes that because the non-controlling interest is required to be
measured at fair value on acquisition of OcuSense, the fair value of the
milestone payments as of the date of acquisition will be embedded in the initial
measurement of non-controlling interest. As such, it would be
inappropriate to record additional minority interest based on the full amount of
the milestone payment applicable to the minority
interest. Accordingly, the Company has accounted for the milestone
payments as follows:
|
·
|
The
Company determined the fair value of the milestone payments on the date of
acquisition, by incorporating the probability that the milestone payments
will be made, as well as the time value associated with the planned
settlement date of the payments.
|
|
·
|
Upon
payment of the milestone payments, the Company recorded the minority
interest portion of the change in fair value of the milestone payment
(i.e. the minority interest portion of the ultimate value of the milestone
payment less the initial fair value determination) as an expense, with a
corresponding increase to minority interest, to reflect the additional
value provided to the minority interest in excess of that contemplated on
the acquisition date.
|
The
following is a summary of the significant effects of the restatements on the
Company’s consolidated balance sheets as of December 31, 2007 and 2006 and its
consolidated statements of operations and cash flows for the fiscal years ended
December 31, 2007 and 2006:
|
|
December
31, 2007
|
|
|
December
31, 2006
|
|
|
|
As
previously reported(1)
|
|
|
Adjustment
|
|
|
As
restated
|
|
|
As
previously reported(1)
|
|
|
Adjustment
|
|
|
As
restated
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible
Assets
|
|
|
5,770,677
|
|
|
|
5,314,377
|
|
|
|
11,085,054
|
|
|
|
26,876,732
|
|
|
|
8,121,723
|
|
|
|
34,998,455
|
|
Deferred
Tax
|
|
|
—
|
|
|
|
2,259,348
|
|
|
|
2,259,348
|
|
|
|
7,851,667
|
|
|
|
3,248,689
|
|
|
|
11,100,356
|
|
Minority
Interest
|
|
|
—
|
|
|
|
4,953,960
|
|
|
|
4,953,960
|
|
|
|
1,184,844
|
|
|
|
4,925,990
|
|
|
|
6,110,834
|
|
Additional
paid-in capital
|
|
|
362,402,899
|
|
|
|
(170,868
|
)
|
|
|
362,232,031
|
|
|
|
354,191,066
|
|
|
|
(15,562
|
)
|
|
|
354,175,504
|
|
Accumulated
deficit
|
|
|
(356,560,917
|
)
|
|
|
(1,728,063
|
)
|
|
|
(358,288,980
|
)
|
|
|
(293,021,603
|
)
|
|
|
(37,394
|
)
|
|
|
(293,058,997
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
7,373,726
|
|
|
|
730,679
|
|
|
|
8,104,405
|
|
|
|
8,407,501
|
|
|
|
68,250
|
|
|
|
8,475,751
|
|
Minority
interest
|
|
|
2,182,843
|
|
|
|
(870,665
|
)
|
|
|
1,312,178
|
|
|
|
157,624
|
|
|
|
3,555
|
|
|
|
161,179
|
|
Recovery
of income taxes
|
|
|
5,654,868
|
|
|
|
(89,326
|
)
|
|
|
5,565,542
|
|
|
|
2,888,490
|
|
|
|
27,300
|
|
|
|
2,915,790
|
|
Loss
from continuing operations
|
|
|
(32,710,416
|
)
|
|
|
(1,690,669
|
)
|
|
|
(34,401,085
|
)
|
|
|
(80,642,119
|
)
|
|
|
(37,394
|
)
|
|
|
(80,679,513
|
)
|
Net
loss for the year
|
|
|
(68,139,314
|
)
|
|
|
(1,690,669
|
)
|
|
|
(69,829,983
|
)
|
|
|
(82,184,503
|
)
|
|
|
(37,394
|
)
|
|
|
(82,221,897
|
)
|
Loss
from continuing operations per share - basic and diluted
|
|
$
|
(0.58
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(1.79
|
)
|
|
|
-
|
|
|
$
|
(1.79
|
)
|
Net
loss per share - basic and diluted
|
|
$
|
(1.20
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(1.23
|
)
|
|
$
|
(1.83
|
)
|
|
|
-
|
|
|
$
|
(1.83
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year
|
|
|
(68,139,314
|
)
|
|
|
(1,690,669
|
)
|
|
|
(69,829,983
|
)
|
|
|
(82,184,503
|
)
|
|
|
(37,394
|
)
|
|
|
(82,221,897
|
)
|
Amortization
of intangibles
|
|
|
4,578,027
|
|
|
|
730,679
|
|
|
|
5,308,706
|
|
|
|
2,749,212
|
|
|
|
68,250
|
|
|
|
2,817,462
|
|
Deferred
income taxes
|
|
|
(15,004,750
|
)
|
|
|
89,325
|
|
|
|
(14,915,425
|
)
)
|
|
|
(4,065,962
|
)
|
|
|
(27,300
|
)
|
|
|
(4,093,262
|
)
|
Minority
interest
|
|
|
(2,182,843
|
)
|
|
|
870,665
|
|
|
|
(1,312,178
|
)
|
|
|
(157,624
|
)
|
|
|
(3,555
|
)
|
|
|
(161,179
|
)
|
|
(1)
|
Amounts
reflected correction of prior years amounts related to stock options
granted to consultants as noted
below.
|
The
impact of the above restatement on the Company’s unaudited quarterly financial
information is presented in Note 22
B. Correction
of an error related to accounting for stock options
In
accordance with the U.S. Securities and Exchange Commission (the “SEC”) Staff
Accounting Bulletin (“SAB”) No. 108, “Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial
Statements”, the Company’s comparative consolidated financial statements have
been corrected to reflect the Company’s accounting for stock options granted
during fiscal 2005 to certain consultants that were subject to performance
conditions. The vesting of these options was contingent upon the
attainment of FDA approval of the RHEO™ System. These stock options
were accounted for in accordance with Statement of Financial Accounting
Standards (“SFAS”) No. 123
“Accounting for Stock-Based
Compensation” (“SFAS No. 123”)
and subsequently in accordance with SFAS
No. 123(R) (revised 2004), “Stock-Based Compensation” (“SFAS No. 123R”) upon the
Company’s adoption of SFAS No. 123(R) on January 1, 2006. The total fair value
of these options was estimated at the date of grant and was being amortized,
over the Company’s estimate of the expected vesting period, as stock-based
compensation expense in the Company’s consolidated statements of
operations. In preparing the consolidated financial statements for
the year ended December 31, 2007, the Company noted that these options should
have been accounted for in accordance with EITF 96-18, “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services”, (“EITF 96-18”) which requires that
if, on the measurement date of the award, the quantity or any of the terms of
the equity instruments are dependent on the achievement of performance
conditions which result in a range of fair values, the lowest aggregate amount
should be used.
Based on
the provisions of EITF 96-18, the Company concluded that no stock-based
compensation expense should have been recorded for these options. Since the
effect of the error on the individual prior periods’ consolidated financial
statements was immaterial, the Company has adjusted the comparative consolidated
financial statements of prior years to reflect the correction of this error
without undertaking a restatement of the prior periods’ consolidated financial
statements. The following financial statement line items for fiscal 2006 and
2005 were affected by the correction of the error:
|
|
Previously
reported
(ii)
|
|
|
Corrected
amount
(ii)
|
|
|
Effect
of error
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Balance
Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
354,320,116
|
|
|
|
354,191,066
|
|
|
|
(129,050
|
)
|
Accumulated
deficit
|
|
|
(293,150,653
|
)
|
|
|
(293,021,603
|
)
|
|
|
129,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
336,977,578
|
|
|
|
336,835,573
|
|
|
|
(142,005
|
)
|
Accumulated
deficit
|
|
|
(210,979,105
|
)
|
|
|
(210,837,100
|
)
|
|
|
142,005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements
of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
(i)
|
|
|
8,452,915
|
|
|
|
8,407,501
|
|
|
|
45,414
|
|
Clinical
and regulatory
(i)
|
|
|
4,956,207
|
|
|
|
4,921,771
|
|
|
|
34,436
|
|
Sales
and marketing
(i)
|
|
|
1,639,428
|
|
|
|
1,625,188
|
|
|
|
14,240
|
|
Loss
from continuing operations
|
|
|
(80,736,209
|
)
|
|
|
(80,642,119
|
)
|
|
|
94,090
|
|
Cumulative
effect of a change in accounting principle
|
|
|
107,045
|
|
|
|
—
|
|
|
|
(107,045
|
)
|
Net
loss for the year
|
|
|
(82,171,548
|
)
|
|
|
(82,184,503
|
)
|
|
|
(12,955
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative expenses
|
|
|
8,729,456
|
|
|
|
8,670,394
|
|
|
|
59,062
|
|
Clinical
and regulatory expenses
|
|
|
5,250,492
|
|
|
|
5,167,549
|
|
|
|
82,943
|
|
Loss
from continuing operations
|
|
|
(162,971,986
|
)
|
|
|
(162,829,981
|
)
|
|
|
142,005
|
|
Net
loss for the year
|
|
|
(162,971,986
|
)
|
|
|
(162,829,981
|
)
|
|
|
142,005
|
|
|
|
Previously
reported
|
|
|
Corrected
amount
|
|
|
Effect
of error
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statements
of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to cash used in operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
(i)
|
|
|
2,221,133
|
|
|
|
2,127,043
|
|
|
|
94,090
|
|
Cumulative
effect of a change in accounting principle
|
|
|
(107,045
|
)
|
|
|
—
|
|
|
|
(107,045
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to cash used in operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
366,781
|
|
|
|
224,776
|
|
|
|
142,005
|
|
(i)
|
The
comparative figures for the year ended December 31, 2006 have been
reclassified to reflect the effect of discontinued
operations.
|
(ii)
|
These
amounts do not reflect any adjustments related to the accounting for the
Company’s investment in OcuSense, as previously
discussed.
|
The
cumulative effect of the correction for the years ended December 31, 2006 and
2005 on basic and diluted net loss per share was nil.
3.
SIGNIFICANT ACCOUNTING POLICIES
The
consolidated financial statements have been prepared by management in conformity
with U.S. GAAP.
The
consolidated financial statements include the accounts of the Company and its
subsidiaries. All significant intercompany transactions and balances have been
eliminated on consolidation.
The
preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the consolidated financial statements and the reported amounts of
revenue and expenses during the reporting periods. Some of the Company’s more
significant estimates include those related to uncollectible receivables,
stock-based compensation, investments and its intangible assets. Actual results
could differ from those estimates.
Revenue
recognition
Prior to
the Company’s announcement of the indefinite suspension of its RHEO™ System
clinical development program, the Company recognized revenue from the sale of
the RHEO™ System, which is comprised of OctoNova pumps and the related
disposable treatment sets, and, prior to the Company’s disposition of SOLX on
December 19, 2007, the Company recognized revenue from the sale of the
components of the SOLX Glaucoma System which includes the
SOLX 790
Laser
and the
SOLX Gold Shunt
. The Company
received a signed binding purchase order from its customers. The pricing was a
negotiated amount between the Company and its customers. The Company sold the
components of the SOLX Glaucoma System directly to physicians and also through
distributors. Revenue has been reported net of distributors’
commissions.
The
Company had the obligation to train its customers and to calibrate the OctoNova
pumps delivered to them. Only upon the completion of these services did the
Company recognize revenue for the pumps. The Company was also responsible for
providing a one-year warranty on the OctoNova pumps, and the estimated cost of
providing this service was accrued at the time revenue was recognized. The
treatment sets and the components of the SOLX Glaucoma System did not require
any additional servicing and revenue was recognized upon passage of title.
However, the Company’s revenue recognition policy requires an assessment as to
whether collectibility is reasonably assured, which requires the Company to
evaluate the creditworthiness of its customers. The result of the assessment
could materially impact the timing of revenue recognition.
Cost
of goods sold
Cost of
sales includes costs of goods sold and royalty costs. The Company’s cost of
goods sold consists primarily of costs for the manufacture of the RHEO™ System,
prior to the Company’s announcement of the indefinite suspension of its RHEO™
System clinical development program,
and the SOLX Glaucoma
System,
prior to
the Company’s disposition of
SOLX
on
December 19, 2007. Cost of sales also includes the costs the Company incurs for
the purchase of component parts from its suppliers, applicable freight and
shipping costs, fees related to warehousing, logistics inventory management and
recurring regulatory costs associated with conducting business and ISO
certification. In addition to these direct costs, included in the cost of goods
sold are licensing costs associated with distributing the RHEO™ System in Canada
and minimum royalty payments due to Mr. Hans Stock and Dr. Richard Brunner that
are only recoverable based on sufficient volume
(notes 11 and
12)
.
Cash
and cash equivalents
Cash and
cash equivalents comprise cash on hand and highly liquid short-term investments
with original maturities of 90 days or less at the date of
purchase.
Investments
consist of investments in auction rate securities. These investments are
classified as available-for-sale securities and are recorded at fair value with
unrealized gains or losses reported in accumulated other comprehensive income
unless the fair value is determined to be less than the carrying value and that
this reduction in value is other than temporary. In such
circumstances, the reduction in the carrying value is included in the
determination of net loss. All of the auction rate securities have contractual
maturities of more than three years.
Bad
debt reserves
The
Company evaluates the collectibility of its accounts receivable based on a
combination of factors. In cases where management is aware of circumstances that
may impair a specific customer’s ability to meet its financial obligations to
the Company, a specific allowance against amounts due to the Company is
recorded, which reduces the net recognized receivable to the amount management
reasonably believes will be collected. For all other customers, the Company
recognizes allowances for doubtful accounts based on the length of time the
receivables are past due, the current business environment and historical
experience. As at December 31, 2007 and 2006, the Company had bad debt reserves
of $172,992 and nil, respectively. The Company expensed amounts related to bad
debt reserves of nil, nil and $518,852 during the years ended December 31, 2007,
2006 and 2005, respectively, and set up a provision for $172,992, nil and
$530,445, representing invoices for products shipped, plus related taxes, to a
customer during the years ended December 31, 2007, 2006 and 2005, respectively,
for which revenue was not recognized due to the likelihood that the customer
would not be able to pay for the amounts invoiced.
Inventory
is recorded at the lower of cost and net realizable value and consists of
finished goods. Cost is accounted for on a first-in, first-out basis. Deferred
cost of sales (included in finished goods) consists of products shipped but not
recognized as revenue because they did not meet the revenue recognition
criteria.
The
Company evaluates its ending inventory for estimated excess quantities and
obsolescence, based on expected future sales levels and projections of future
demand, with the excess inventory provided for. In addition, the Company
assesses the impact of changing technology, market conditions
and the question of whether recent
transactions provide indicators as to whether the net realizable value of its
inventory is below its recorded cost.
In
April 2006, the Company sold a number of treatment sets to Veris Health Sciences
Inc. (“Veris”) at a price lower than the Company’s cost. Accordingly,
the Company wrote down the value of its treatment sets to reflect this current
net realizable value during the year ended December 31, 2006. In light of the
Company’s current financial position, on November 1, 2007, the Company announced
an indefinite suspension of the RHEO™ System clinical development program for
Dry AMD. That decision was made following a comprehensive review of
the respective costs and development timelines associated with the products in
the Company’s portfolio and, in particular, the fact that, if the Company had
been unable to raise additional capital, it would not have had sufficient cash
to support its operations beyond early 2008. Accordingly, the Company has
written down the value of its treatment sets and OctoNova pumps, the components
of the RHEO™ System, to nil as of December 31, 2007 since the Company is not
expected to be able to sell or utilize these treatment sets and OctoNova pumps
prior to their expiration dates, in the case of the treatment sets, or before
the technologies become outdated.
As at December 31, 2007 and 2006, the
Company had inventory reserves of $7,295,545 and $5,101,394, respectively.
During the years ended December 31, 2007, 2006 and 2005, the Company recognized
a provision related to inventory of $2,790,209, $3,304,124 and $1,990,830,
respectively, based on the above analysis.
Fair
value of financial instruments
Fair
value of a financial instrument is defined as the amount at which the instrument
could be exchanged in a current transaction between willing parties. The
estimated fair values of cash and cash equivalents, amounts receivable, accounts
payable, accrued liabilities and amounts due from and to stockholders
approximate their carrying values due to the short-term maturities of these
instruments.
Fixed
assets are recorded at cost less accumulated amortization. Amortization is
calculated using the straight-line method, commencing when the assets become
available for productive use, based on the following estimated useful
lives:
Furniture
and office equipment
|
2 –
7 years
|
Computer
equipment and software
|
3
years
|
Leasehold
improvements
|
Shorter
of useful life or initial term of the lease
|
Medical
equipment
|
1 –
5 years
|
Impairment
of long-lived assets
The
Company reviews its fixed assets and intangible assets for impairment whenever
events or changes in circumstances indicate that the carrying amount of an asset
might not be recoverable. When such an event occurs, management estimates the
future undiscounted cash flows expected to result from the use of the asset and
its eventual disposition. In the event the undiscounted cash flows are less than
the carrying amount of the asset, an impairment loss equal to the excess of the
carrying amount over the fair value is charged to operations.
The
Company’s intangible assets as at December 31, 2007 are comprised of the value
of the exclusive distribution agreements the Company had with Asahi Medical,
Diamed and MeSys and the value of the TearLab™ technology acquired upon the
acquisition of 50.1% of the capital stock of OcuSense on a fully diluted basis
57.62% on an issued and outstanding basis. The Company’s intangible assets are
being amortized using the straight-line method over an estimated useful life of
10 years.
Patents
and trademarks
Patents
and trademarks are recorded at historical cost and are amortized using the
straight-line method over their estimated useful lives, not to exceed 15
years.
Goodwill
Goodwill
is not amortized and instead is subject to an annual impairment test. The
Company’s annual impairment test is conducted effective October 1 and is
evaluated between annual tests upon the occurrence of certain events or
circumstances. Goodwill impairment is assessed based on a comparison of the fair
value of the reporting unit to the underlying carrying value of the reporting
unit’s net assets, including goodwill. When the carrying amount of the reporting
unit exceeds its fair value, the fair value of the reporting unit’s goodwill is
compared with its carrying amount to measure the amount of impairment loss, if
any.
Foreign
currency translation
The
Company’s functional and reporting currency is the U.S. dollar. The assets and
liabilities of the Company’s Canadian operations are maintained in U.S. dollars.
Monetary assets and liabilities denominated in foreign currencies are translated
into U.S. dollars at exchange rates in effect at the consolidated balance sheet
dates, and non-monetary assets and liabilities are translated at exchange rates
in effect on the date of the transaction. Revenue and expenses are translated
into U.S. dollars at average exchange rates prevailing during the year.
Resulting exchange gains and losses are included in net loss for the year and
are not material in any of the years presented.
Clinical
and regulatory costs
Clinical
and regulatory costs attributable to the performance of contract services are
recognized as the services are performed. Non-refundable, up-front fees paid in
connection with these contracted services are deferred and recognized as an
expense on a straight-line basis over the estimated term of the related
contract.
On
January 1, 2007, the Company adopted the provisions of Financial Accounting
Standards Board (“FASB”) Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes – An Interpretation of FASB Statement No. 109” (“FIN No. 48”). FIN
No. 48 addresses the determination of whether tax benefits claimed or expected
to be claimed on a tax return should be recorded in the financial
statements. Under FIN No. 48, the Company may recognize the tax
benefit from an uncertain tax position only if it is more likely than not that
the tax position will be sustained on examination by the taxing authorities,
based on the technical merits of the position. The tax benefits
recognized in the consolidated financial statements from such a position should
be measured based on the largest benefit that has a greater than 50% likelihood
of being realized upon ultimate settlement. FIN No. 48 also provides guidance on
derecognition, classification, interest and penalties on income taxes and
accounting in interim periods and requires increased disclosure.
As a
result of the implementation of the provisions of FIN No. 48, the Company
recognized a reduction to the January 1, 2007 deferred tax liability balance in
the amount of $4.6 million with a corresponding reduction to accumulated
deficit.
As of
January 1, 2007, the Company had unrecognized tax benefits of $24.8 million
which, if recognized, would favorably affect the Company’s effective tax
rate.
When
applicable, the Company recognizes accrued interest and penalties related to
unrecognized tax benefits as other expense in its consolidated statements of
operations, which is consistent with the recognition of these items in prior
reporting periods. As of January 1, 2007, the Company did not have any liability
for the payment of interest and penalties.
The
Company does not expect a significant change in the amount of its unrecognized
tax benefits within the next 12 months. Therefore, it is not expected that the
change in the Company’s unrecognized tax benefits will have a significant impact
on the results of operations or financial position of the Company.
However,
a portion of the Company’s net operating losses may be subject to annual
limitations as a result of the Company’s initial public offering and prior
changes of control. Accordingly, until a formal analysis of the effect of the
changes of control is performed, a portion of the income tax benefits recognized
to date may be affected.
All
federal income tax returns for the Company and its subsidiaries remain open
since their respective dates of incorporation due to the existence of net
operating losses. The Company and its subsidiaries have not been, nor
are they currently, under examination by the Internal Revenue Service or the
Canada Revenue Agency.
State and
provincial income tax returns are generally subject to examination for a period
of between three and five years after their filing. However, due to
the existence of net operating losses, all state income tax returns of the
Company and its subsidiaries since their respective dates of incorporation are
subject to re-assessment. The state impact of any federal changes
remains subject to examination by various states for a period of up to one year
after formal notification to the states. The Company and its
subsidiaries have not been, nor are they currently, under examination by any
state tax authority.
The
Company accounts for stock-based compensation expense for its employees in
accordance with the provisions of SFAS No. 123R. Under the fair value
recognition provision of SFAS No. 123R, stock-based compensation cost is
estimated at the grant date based on the fair value of the award and is
recognized as an expense ratably over the requisite service period of the award.
The Company has selected the
Black-Scholes option-pricing model as its method of determining the fair value
for all its awards and will recognize compensation cost on a straight-line basis
over the awards’ vesting
periods
(note 16(e)).
The
Company follows SFAS No. 128, “Earnings Per Share” (“SFAS No. 128”). In
accordance with SFAS No. 128, companies that are publicly held or have complex
capital structures are required to present basic and diluted earnings per share
(“EPS”) on the face of the statement of income. Basic EPS excludes dilution and
is computed by dividing net loss available to common stockholders by the
weighted average number of shares of common stock outstanding for the year.
Diluted EPS reflects the potential dilution that could occur if securities or
other contracts to issue common stock were exercised or converted and the
resulting additional shares are dilutive because their inclusion decreases the
amount of EPS.
The
following are potentially dilutive securities which have not been used in the
calculation of diluted loss per share as they are anti-dilutive:
|
|
Years
ended December 31,
|
|
|
|
|
2007
#
|
|
|
|
2006
#
|
|
|
|
2005
#
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options
|
|
|
4,787,387
|
|
|
|
4,237,221
|
|
|
|
4,107,614
|
|
Warrants
|
|
|
2,764,416
|
|
|
|
—
|
|
|
|
—
|
|
Comprehensive
income
The
Company follows SFAS No. 130, “Reporting Comprehensive Income” (“SFAS No. 130”).
SFAS No. 130 establishes standards for reporting and the presentation of
comprehensive income and its components in a full set of financial statements.
SFAS No. 130 requires only additional disclosures in the financial statements
and does not affect the Company’s financial position or results of
operations.
Comparative
figures
Certain
of the comparative figures have been reclassified to conform to the current
year’s method of presentation and to reflect the effect of discontinued
operations.
Recent
accounting pronouncements
The adoption of
SAB
No.
1
10
,
“
Share-based
payments
”
,
during fiscal 2007 did not
have a material impact on
the Company’s
results of operations and financial
position
.
In September 2006, FASB issued
S
FAS
No. 157, “Fair Value Measurements”
(“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework and
gives guidance regarding the methods used for measuring fair value, and expands
disclosures about fair value measurements. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning
on or
after November 15, 2007 and for interim
periods within those fiscal years.
On February 12, 2008, FASB issued FASB
Staff Position No. 157-2, “Effective Date of FASB Statement No 157” (FSP No.
157-2”)
.
FSP No. 157-2 amends SFAS No. 157 to
delay the effective date of SFAS No. 157 for non-financial assets and
non-financial liabilities, except for items that are recognized or disclosed at
fair value in the financial statements on a recurring basis (at least annually)
for fiscal years beginning after November 15, 2008.
On
February 14, 2008, FASB issued FSP No. 157-1, “Application of FASB Statement No.
157 to FASB Statement No. 13 and Other Accounting Pronouncements that Address
Fair Value Measurements for Purposes of Lease Classification or Measurement
under Statement 13” (“FSP No. 157-1”). FSP No. 157-1 amends SFAS No.
157 to exclude SFAS No. 13, “Accounting for Leases” (“SFAS No. 13”), and other
accounting pronouncements that address fair value measurements for purposes of
lease classification or measurement under SFAS No. 13.
The
Company is currently evaluating the impact that the adoption of SFAS No. 157,
FSP No. 157-2 and FSP No. 157-1 will have on its results of operations and
financial position.
In
February 2007, FASB issued SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities—Including an amendment of FASB Statement No.
115” (“SFAS No. 159”). SFAS No. 159 expands the use of fair value accounting but
does not affect existing standards which require assets or liabilities to be
carried at fair value. Under SFAS No. 159, a company may elect to use fair value
to measure accounts and loans receivable, available-for-sale and
held-to-maturity securities, equity method investments, accounts payable,
guarantees and issued debt. Other eligible items include firm commitments for
financial instruments that otherwise would not be recognized at inception and
non-cash warranty obligations where a warrantor is permitted to pay a third
party to provide the warranty goods or services. If the use of fair value is
elected, any up-front costs and fees related to the item must be recognized in
earnings and cannot be deferred (e.g., debt issue costs). The fair value
election is irrevocable and generally made on an instrument-by-instrument basis,
even if a company has similar instruments that it elects not to measure based on
fair value. At the adoption date, unrealized gains and losses on existing items
for which fair value has been elected are reported as a cumulative adjustment to
beginning retained earnings. Subsequent to the adoption of SFAS No. 159, changes
in fair value are recognized in earnings. SFAS No. 159 is effective for fiscal
years beginning on or after November 15, 2007 and is required to be adopted by
the Company in the first quarter of fiscal 2008. The adoption of SFAS No. 159
will not have a material impact on the Company’s results of operations and
financial position.
In June
2007, FASB’s EITF issued EITF No. 06-11, “Accounting for Income Tax
Benefits of Dividends on Share-Based Payment Awards” (“EITF No. 06-11”). EITF
No. 06-11 requires that the tax benefits related to dividend equivalents paid on
restricted stock units, which are expected to vest, be recorded as an increase
to additional paid-in capital. EITF No. 06-11 is effective prospectively to the
income tax benefits on dividends declared in fiscal years beginning on or after
December 15, 2007. The Company is currently evaluating the impact the adoption
of EITF No. 06-11 will have on its results of operations and financial
position.
In
December 2007, FASB issued SFAS No. 141R (revised 2007), “Business Combinations
(a revision of Statement No. 141)” (“SFAS No. 141R”). SFAS No. 141R applies to
all transactions or other events in which an entity obtains control of one or
more businesses, including those business combinations achieved without the
transfer of consideration. SFAS No. 141R retains the fundamental requirements in
Statement No. 141 that the acquisition method of accounting be used for all
business combinations. SFAS No. 141R expands the scope to include all business
combinations and requires an acquirer to recognize the assets acquired, the
liabilities assumed, and any non-controlling interest in the acquiree at their
fair values as of the acquisition date. In addition, SFAS No. 141R changes the
way entities account for business combinations achieved in stages by requiring
the identifiable assets and liabilities to be measured at their full fair
values. Also, contractual contingencies and contingent consideration shall be
measured at fair value at the acquisition date. SFAS No. 141R is effective on a
prospective basis to business combinations for which the acquisition date is on
or after the beginning of the first annual reporting period beginning on or
after December 15, 2008. The Company is currently evaluating the impact, if any,
that the adoption of SFAS No. 141R will have on its results of operations and
financial position.
In
December 2007, FASB issued Statement No. 160, “Noncontrolling Interests in
Consolidated Financial Statements - an amendment of ARB No. 51” (“SFAS No.
160”). SFAS No. 160 amends ARB 51 to establish accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. SFAS No. 160 clarifies that a non-controlling
interest in a subsidiary is an ownership interest in the consolidated entity
that should be reported as equity in the consolidated financial statements.
Additionally, SFAS No. 160 requires that consolidated net income include the
amounts attributable to both the parent and the non-controlling interest. SFAS
No. 160 is effective for interim periods beginning on or after December 15,
2008. The Company is currently evaluating the impact, if any, that the adoption
of SFAS No. 160 will have on its results of operations and financial
position.
4.
ACQUISITIONS
During
the fiscal year ended December 31, 2006, the Company completed two acquisitions.
The results of each purchase acquisition are included in the Company’s
consolidated statements of operations from the date of each acquisition. There
were no acquisitions made during fiscal 2007.
The
Company’s acquisitions during fiscal 2006 are described below.
Solx,
Inc.
On
September
1,
2006, the Company acquired
SOLX,
a privately held company that has
developed a system for the treatment of glaucoma
.
The
SOLX Glaucoma System developed by SOLX
includes the SOLX 790 Laser and the
SOLX Gold Shunt which
can be used separately or together to
provide physicians with multiple options to manage intraocular pressure. The
acquisition of SOLX represented an expansion of the Company’s ophthalmic product
portfolio beyond the RHEO™ procedure for Dry AMD.
The results of SOLX’s operations have
been included in the Company’s consolidated financial statements since September
1, 2006.
The
Company acquired SOLX by way of a merger, in connection with which the Company
issued an aggregate of 8,399,983 shares of its common stock and paid $7,000,000
in cash to the stockholders of SOLX. The Company made an additional payment of
$3,000,000 in cash on the first anniversary of the September 1, 2006 closing and
was expected to make an additional payment of $5,000,000 in cash to the former
stockholders of SOLX on the second anniversary of the September 1, 2006
closing. In addition, if SOLX received final FDA approval for the
marketing and sale of the SOLX Gold Shunt on or prior to December 31, 2007, the
Company was expected to make an additional payment of $5,000,000 in cash to the
former stockholders of SOLX. The stock consideration was valued based on a per
share price of $1.79, being the weighted-average closing sale price of the
Company’s
common stock as traded
on the NASDAQ Global Market (“NASDAQ”) over the two-day trading period before
and after August 1, 2006, being the date the terms of the acquisition of SOLX
were agreed to and announced. The Company recorded the cash payment
paid on the
first anniversary of the closing date as a current liability
as of December 31, 2006. The $5,000,000 due on the second anniversary of the
closing date was recorded as a long-term liability at its present value,
discounted at the incremental borrowing rate of the Company as at August 1,
2006. The difference between the discounted value and the $5,000,000 payable was
being amortized using the effective yield method over the two-year period with
the monthly expense being charged as an interest expense in the Company’s
consolidated statements of operations. In accordance with
SFAS No. 141, “Business Combinations”,
t
he contingent payment of $5,000,000 was not included in the
determination of the purchase price or recorded as a liability as the receipt of
FDA approval for the marketing and sale of the SOLX Gold Shunt on or prior to
December 31, 2007 was subject to many variables, the outcome of which was not
determinable beyond reasonable doubt.
The total purchase price of $29,068,443,
which included acquisition-related transaction costs of $851,279, was allocated
as follows:
|
|
$
|
|
|
|
|
|
|
Net tangible
assets
|
|
|
(2,908,384
|
)
|
Deferred tax
liability
|
|
|
(12,270,150
|
)
|
Intangible
assets:
|
|
|
|
|
Shunt
and laser
technology
|
|
|
27,000,000
|
|
Regulatory and
other
|
|
|
2,800,000
|
|
|
|
|
14,621,466
|
|
Goodwill
|
|
|
14,446,977
|
|
|
|
|
29,068,443
|
|
Acquisition-related
transaction costs included investment banking, legal and accounting fees and
other third-party costs directly related to the acquisition.
In estimating the fair value of the
intangible assets acquired, the Company considered a number of factors,
including discussion with SOLX management, review of historic financial
information, future revenue and expense estimates and a review of the economic
and competitive environment. As a result, the Company used the income approach
to value SOLX’s s
hunt
and laser technology (consisting of the
SOLX Gold Shunt and the
SOLX 790 Laser) and the cost approach to value the regulatory and other
intangible assets acquired
(note 8)
.
On
December 19, 2007, the Company sold all of the issued and outstanding capital
stock of SOLX to Solx Acquisition. The consideration for the purchase and sale
of all of the issued and outstanding shares of the capital stock of SOLX
consisted of: (i) on the closing date of the sale, the assumption by
Solx Acquisition of all of the liabilities of the Company related to SOLX’s
business, incurred on or after December 1, 2007, and the Company’s obligation to
make a $5,000,000 payment to the former stockholders of SOLX due on September 1,
2008 in satisfaction of the outstanding balance of the purchase price of SOLX;
(ii) on or prior to February 15, 2008, the payment by Solx Acquisition of all of
the expenses that the Company had paid to the closing date, as they related to
SOLX’s business during the period commencing on December 1, 2007; (iii) during
the period commencing on the closing date and ending on the date on which SOLX
achieves a positive cash flow, the payment by Solx Acquisition of a royalty
equal to 3% of the worldwide net sales of the SOLX 790 Laser and the SOLX Gold
Shunt, including next-generation or future models or versions of these products;
and (iv) following the date on which SOLX achieves a positive cash flow, the
payment by Solx Acquisition of a royalty equal to 5% of the worldwide net sales
of these products. In order to secure the obligation of Solx Acquisition to make
these royalty payments, SOLX granted to the Company a subordinated security
interest in certain of its intellectual property. The results of operations of
SOLX from September 1, 2006, the date the Company acquired SOLX, to December 19,
2007, the closing date of the sale, have been included in discontinued
operations in the Company’s consolidated statements of operations
(note
10)
.
OcuSense,
Inc.
On
November 30, 2006, the Company acquired 50.1% of the capital stock of OcuSense,
measured on a fully diluted basis, and 57.62% measured on an issued and
outstanding basis. OcuSense’s first product, which is currently under
development, is a hand-held tear film test for the measurement of osmolarity, a
quantitative and highly specific biomarker that has shown to correlate with dry
eye disease, or DED. The test is known as the TearLab™ test for DED.
The results of OcuSense’s operations
have been included in the Company’s consolidated financial statements since
November 30, 2006.
Pursuant
to the terms of the Series A Preferred Stock Purchase Agreement (the "Series A
Preferred Stock Purchase Agreement"), dated as of November 30, 2006, between
OcuSense and the Company, the Company purchased 1,754,589 shares of OcuSense's
Series A Preferred Stock, par value of $0.001 per share, representing 50.1% of
OcuSense's capital stock on a fully diluted basis, and 57.62% on an issued and
outstanding basis, for an initial purchase price of $4,000,000. OccuLogix paid
$2,000,000 of the initial purchase price on the closing of the purchase, which
took place on November 30, 2006 and paid $2,000,000, the balance of the initial
purchase price, on January 3, 2007. In connection with the purchase, OccuLogix
incurred transaction costs of $171,098, thus establishing the total initial
purchase price at $4,171,098. In addition, pursuant to the Series A Stock
Purchase Agreement, the Company was obligated to make two additional payments to
OcuSense of $2,000,000 each, subject to OcuSense's achievement of two
pre-defined milestones. In June 2007, the Company made the first of these
$2,000,000 payments to OcuSense upon its achievement of the first of these two
pre-defined milestones. The Company will make the second of these $2,000,000
payments upon the achievement by OcuSense of the second of the two pre-defined
milestones, provided that that milestone is achieved prior to May 1,
2009.
OcuSense
is considered to be a VIE and OccuLogix is considered to be the primary
beneficiary of OcuSense’s activities. Accordingly, under FIN 46(R), the assets,
liabilities and non-controlling interest shall be measured initially
at their fair value.
Assets
acquired and liabilities assumed consisted primarily of working capital and of a
technology intangible asset relating to patents owned by
OcuSense. Before consideration of deferred tax, the fair value of the
assets acquired was greater than the fair value of the liabilities assumed and
the non-controlling interest. Because OcuSense does not comprise a
business, as defined in EITF 98-3, “Determining Whether a Nonmonetary
Transaction Involves Receipt of Productive Assets or of a Business”, the
Company applied the simultaneous equation method as per EITF 98-11,
“Accounting for Acquired Temporary Differences in Certain Purchase Transactions
That Are Not Accounted for as Business Combinations”, and adjusted the assigned
value of the non-monetary assets acquired (consisting solely of the technology
asset) to include the deferred tax liability.
The fair
values of OcuSense’s assets, liabilities and minority interest, at
the date of acquisition, were as follows:
|
|
As
at November 30
|
|
|
|
2006
|
|
|
|
|
|
Net
tangible assets
|
|
$
|
2,690,316
|
|
Intangible
assets
|
|
$
|
12,895,388
|
|
Deferred
taxes
|
|
$
|
(5,158,155
|
)
|
Minority
interest
|
|
$
|
(6,256,451
|
)
|
|
|
$
|
4,171,098
|
|
|
|
|
|
|
In estimating the fair value of the
intangible assets acquired, the Company considered a number of factors,
including the valuation performed by an independent third-party valuator that
used the income approach to value OcuSense’s TearLab™ technology
(note 8)
.
5.
GOODWILL
The Company follows the provisions of
SFAS No. 142, “Goodwill and Other Intangible Assets” (“SFAS No. 142”), which
requires that goodwill not be amortized but instead be tested for impairment at
least annually and more frequently if circumstances indicate possible
impairment.
The Company’s goodwill amount by
reporting unit is as follows:
|
|
Retina
|
|
|
Glaucoma
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31,
200
5
|
|
|
65,945,686
|
|
|
|
—
|
|
|
|
65,945,686
|
|
Acquired during the
year
|
|
|
—
|
|
|
|
14,446,977
|
|
|
|
14,446,977
|
|
Impairment loss
recognized
|
|
|
(
65,945,686
|
)
|
|
|
—
|
|
|
|
(
65,945,686
|
)
|
Balance, December 31,
200
6
|
|
|
—
|
|
|
|
14,446,977
|
|
|
|
14,446,977
|
|
Impairment loss
recognized
|
|
|
—
|
|
|
|
(14,446,977
|
)
|
|
|
(
14,446,977
|
)
|
Balance, December 31,
2007
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
The Company perform
s
its
annual
goodwill
impairment analysis on its acquired
goodwill on October 1 of each year and evaluates the carrying value of its
goodwill between annual tests upon the occurrence of certain events and
circumstances
.
Retina
The Company conducted a pivotal clinical
trial, called MIRA-1, which, if successful, was expected to support its
application to the FDA to obtain approval to market the RHEO™ System in the
United States
. On February 3, 2006, the Company
announced that, based on a preliminary analysis of the data from MIRA-1, MIRA-1
did not meet its primary efficacy endpoint as it did not demonstrate a
statistically significant difference in the mean change of
ETDRS BCVA
between the treated and placebo groups
in MIRA-1 at 12 months post-baseline.
As a result of the announcement on
February 3, 2006,
the per
share price of the Company’s
common
stock as traded on
NASDAQ decreased from $12.75 on February
2, 2006 to close at $4.10 on February 3, 2006. The 10-day average price of the
stock immediately following the announcement was $3.65 and reflected a decrease
in
the
Company’s
market
capitalization from $536.6 million on February 2, 2006 to $153.6 million based
on the 10-day average share price subsequent to the announcement.
Based on this, the Company concluded
that there were sufficient indicators to require management to re-assess whether
the Company’s recorded goodwill was impaired as of December 31,
2005.
Prior to the acquisition of SOLX and
OcuSense during the second half of fiscal 2006, t
he Company
was
a single reporting unit. Therefore,
management determined the fair value of
the Company’s
goodwill using
the Company’s
market capitalization as opposed to the
fair value of its assets and liabilities.
The Company recorded a goodwill
impairment charge of $147,451,758 during the year ended December 31, 2005 as a
result of a goodwill impairment re-assessment performed subsequent to the
February 3, 2006 announcement.
On June
12
, 2006, the Company announced that it
met with the FDA to discuss the results of MIRA-1 and
confirmed that the FDA will
require the Company to perform an
additional study of the RHEO™ System
to obtain approval to market the RHEO™
System in the
United
States
.
In addition, on June 30, 2006, the
Company announced that it had terminated negotiations with Sowood Capital
Management LP in connection with a proposed private purchase of approximately
$30,000,000 of zero-coupon convertible notes of the Company. In accordance with
SFAS No. 142,
the
Company
concluded that,
b
ased
on the price of the Company’s common
stock
subsequent to the
June
12
, 2006 announcemen
t and again after the June 30, 2006
announcement,
t
here were sufficient indicators to
require management to re-assess whether the Company’s recorded
goodwill
was impaired
as at
June
30, 2006
. Based on the goodwill impairment
analysis performed, the Company concluded that a further goodwill impairment
charge of $65,945,686 should be recorded during the second quarter of
2006.
Glaucoma
On
September 1, 2006, the Company acquired SOLX by way of a merger for a total
purchase price of $29,068,443. Of this amount, $14,446,977 has been allocated to
goodwill. On December 19, 2007, the Company sold to Solx Acquisition, and Solx
Acquisition purchased from the Company, all of the issued and outstanding shares
of the capital stock of SOLX, which had been the Glaucoma Division of the
Company prior to the completion of the transactions provided for in the stock
purchase agreement. The sale transaction established fair values for the
Company’s recorded goodwill and certain of the Company’s intangible assets.
Accordingly, the Company performed an impairment test of its recorded goodwill
to re-assess whether its recorded goodwill was impaired as at December 1, 2007.
Based on the goodwill impairment analysis performed,
the Company concluded that a goodwill
impairment charge of $14,446,977 should be recorded during the year ended
December 31, 2007 to write down the value of its recorded goodwill to its fair
value of nil
(note
10).
6.
FIXED ASSETS
|
|
2007
|
|
|
2006
|
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Furniture
and office equipment
|
|
|
101,903
|
|
|
|
50,854
|
|
|
|
119,776
|
|
|
|
49,566
|
|
Computer
equipment and software
|
|
|
197,317
|
|
|
|
155,928
|
|
|
|
268,955
|
|
|
|
145,001
|
|
Leasehold
improvements
|
|
|
6,335
|
|
|
|
704
|
|
|
|
—
|
|
|
|
—
|
|
Medical
equipment
|
|
|
1,163,135
|
|
|
|
1,138,918
|
|
|
|
1,805,228
|
|
|
|
1,138,675
|
|
|
|
|
1,468,690
|
|
|
|
1,346,404
|
|
|
|
2,193,959
|
|
|
|
1,333,242
|
|
Less
accumulated amortization
|
|
|
1,346,404
|
|
|
|
|
|
|
|
1,333,242
|
|
|
|
|
|
|
|
|
122,286
|
|
|
|
|
|
|
|
860,717
|
|
|
|
|
|
Amortization
expense was $844,948, $213,488 and $99,301 during the years ended December 31,
2007, 2006 and 2005, respectively, of which $231,542, $74,610 and nil is
included as amortization expense of discontinued operations for the years ended
December 31, 2007, 2006 and 2005, respectively
(note 10)
.
On
November 1, 2007, the Company announced an indefinite suspension of the RHEO™
System clinical development program for Dry AMD and is in the process of winding
down the RHEO-AMD study as there is no reasonable prospect that the RHEO™ System
clinical development program will be relaunched in the foreseeable future. In
accordance with SFAS No. 144,
“Accounting for the Impairment or
Disposal of Long-Lived Assets” (“SFAS No. 144”)
, the Company determined
that the carrying value of certain of the Company’s medical equipment was not
recoverable as of December 31, 2007. Accordingly, during the year ended December
31, 2007, the Company recorded a reduction to the carrying value of certain of
its medical equipment of $431,683 which reflects a write-down of the value of
this medical equipment to nil as of December 31, 2007. The assets written down
were being used in the clinical trials of the RHEO™ System. The Company did not
write down the carrying value of any of its fixed assets during the years ended
December 31, 2006 and 2005.
7.
PATENTS AND TRADEMARKS
|
|
2007
|
|
|
2006
|
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
|
|
|
236,854
|
|
|
|
113,013
|
|
|
|
139,461
|
|
|
|
14,909
|
|
Trademarks
|
|
|
120,211
|
|
|
|
104,615
|
|
|
|
117,513
|
|
|
|
7,224
|
|
|
|
|
357,065
|
|
|
|
217,628
|
|
|
|
256,974
|
|
|
|
22,133
|
|
Less
accumulated amortization
|
|
|
217,628
|
|
|
|
|
|
|
|
22,133
|
|
|
|
|
|
|
|
|
139,437
|
|
|
|
|
|
|
|
234,841
|
|
|
|
|
|
Amortization
expense was $195,494, $5,608 and $5,712 during the years ended December 31,
2007, 2006 and 2005, respectively.
Based on
the November 1, 2007 announcement and in accordance with SFAS No. 144, the
Company determined that the carrying value of certain of the Company’s patents
and trademarks was not recoverable as of December 31, 2007. Accordingly, during
the year ended December 31, 2007, the Company recorded a $190,873 reduction to
the carrying value of its patents and trademarks related to the RHEO™ System,
which reflects a write-down of these patents and trademarks to a value of nil as
of December 31, 2007. The Company did not write down the carrying value of any
of its patents and trademarks during the years ended December 31, 2006 and
2005.
The
Company’s recorded patents and trademarks as of December 31, 2007 relate to the
cost of pending applications for patents and trademarks for the TearLab™
technology. These patents and trademarks will be amortized, using the
straight-line method, over an estimated useful life of 10 years from the date of
approval of the patents and trademarks.
Estimated
amortization expense for patents and trademarks for each of the next five years
is as follows:
|
|
Patents
$
|
|
|
Trademarks
$
|
|
|
Total
$
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
12,384
|
|
|
|
1,560
|
|
|
|
13,944
|
|
2009
|
|
|
12,384
|
|
|
|
1,560
|
|
|
|
13,944
|
|
2010
|
|
|
12,384
|
|
|
|
1,560
|
|
|
|
13,944
|
|
2011
|
|
|
12,384
|
|
|
|
1,560
|
|
|
|
13,944
|
|
2012
|
|
|
12,384
|
|
|
|
1,560
|
|
|
|
13,944
|
|
|
|
|
61,920
|
|
|
|
7,800
|
|
|
|
69,720
|
|
8.
INTANGIBLE ASSETS
The Company’s intangible assets consist
of the value of the exclusive distribution agreements that the Company has with
its major suppliers and other acquisition-related intangibles. The Company has
no indefinite-lived intangible assets. The distribution agreements were being
amortized
using the straight-line method over an
estimated useful life of 15 years while the other acquisition-related intangible
assets are amortized using the straight-line method over an estimated
useful life of 10 years,
respectively. Amortization expense for the years ended December 31, 2007, 2006
and 2005 was $5,308,706, $2,817,462 and $1,716,667, respectively
, of
which $2,731,667, $993,333 and nil is included as amortization expense of
discontinued operations for the years ended December 31, 2007, 2006 and 2005,
respectively
(note
10)
.
Intangible assets subject to
amortization consist of the following:
|
|
As
at December 31, 2007
|
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
|
$
|
|
|
$
|
|
Distribution
agreements
|
|
|
—
|
|
|
|
—
|
|
Shunt and laser
technology
|
|
|
—
|
|
|
|
—
|
|
Regulatory and
other
|
|
|
—
|
|
|
|
—
|
|
TearLab™
technology
|
|
|
12,482,054
|
|
|
|
1,397,000
|
|
|
|
|
12,
482
,
054
|
|
|
|
1,397,000
|
|
Intangible assets were reduced by
$413,333 in the year to reflect the effect of tax losses benefited which
became unrestricted in the year.
|
|
|
|
As
at December 31, 2006
|
|
|
|
Cost
|
|
|
Accumulated
Amortization
|
|
|
|
$
|
|
|
$
|
|
Distribution
agreements
|
|
|
25,750,000
|
|
|
|
3,539,471
|
|
Shunt and laser
technology
|
|
|
27,000,000
|
|
|
|
900,000
|
|
Regulatory and
other
|
|
|
2,800,000
|
|
|
|
93,333
|
|
TearLab™
technology
|
|
|
12,895,388
|
|
|
|
107,462
|
|
|
|
|
68,445,388
|
|
|
|
4,640,266
|
|
Estimated amortization expense for the
intangible assets
and
contemporaneous reduction in a preexisting valuation allowance
for each of the next five years and
thereafter is as follows
:
|
|
Amortization of intangible
assets
|
|
|
|
$
|
|
2008
|
|
|
1,289,539
|
|
2009
|
|
|
1,289,539
|
|
2010
|
|
|
1,289,539
|
|
2011
|
|
|
1,289,539
|
|
2012 and
thereafter
|
|
|
5,926,898
|
|
|
|
|
11,085,054
|
|
The Company’s
intangible assets consist of the value
of the exclusive distribution agreements the Company has with Asahi Medical,
the
manufacturer of the Rheofilter
filter
s
and the Plasmaflo filter
s
, and Diamed and MeSys, the designer and
the
manufacturer, respectively, of the
OctoNova pump
s
. The Rheofilter filter,
the
Plasmaflo filter and
the
OctoNova pump are components of the
RHEO™ System,
the
Company’s
product for the
treatment of Dry AMD.
On
November 1, 2007, the Company announced
an indefinite suspension of the RHEO™ System clinical development program for
Dry
AMD
and is in the process of
winding down the RHEO-AMD study as there is no reasonable prospect that the
RHEO™ System clinical development program will be relaunched in the foreseeable
future
.
In accordance with SFAS No. 144, the
Company concluded that
its
indefinite suspension of
the RHEO™ System clinical development
program for Dry AMD
was a
significant event which may affect the carrying value of its distribution
agreements. Accordingly, m
anagement
was required to re-assess whether
the
carrying
value of
the Company’s
distribution agreements was
recoverable
as of
December 31
, 2007.
Based on management’s estimates of
undiscounted cash flows associated with the distribution agreements, the Company
concluded that the carrying value of the distribution agreements was not
recoverable as of December 31, 2007. Accordingly, the Company recorded an
impairment charge of $20,923,028 during the year ended December 31, 2007 to
record the distribution agreements at their fair value as of December 31,
2007.
On
December 19, 2007, the Company sold to Solx Acquisition all of the issued and
outstanding shares of the capital stock of SOLX, which had been the Glaucoma
Division of the Company prior to the completion of the transactions provided for
in the stock purchase agreement. The sale transaction established fair values
for the Company’s recorded goodwill and the Company’s shunt and laser technology
and regulatory and other intangible assets acquired upon the acquisition of SOLX
on September 1, 2006.
Accordingly, m
anagement
was required to re-assess whether
the
carrying
value of
the Company’s
shunt and laser technology
and regulatory and other
intangible assets
was
recoverable
as of
December 1
, 2007.
Based on management’s estimates of
undiscounted cash flows associated with these intangible assets, the Company
concluded that the carrying value of these intangible assets was not recoverable
as of December 1, 2007. Accordingly, the Company recorded an impairment charge
of $22,286,383 during the year ended December 31, 2007 to record the
shunt and laser technology and regulatory and other
intangible assets
at their fair value as of December 31,
2007
(note 10)
.
The
Company determined that, as of December 31, 2007, there
have been no significant events which
may affect the carrying value of its TearLab™ technology.
However, the
Company’s prior history of losses and losses incurred during the current fiscal
year reflects a potential indication of impairment, thus requiring management to
assess whether the Company’s
TearLab™ technology
was impaired
as of December 31, 2007. Based on management’s estimates of forecasted
undiscounted cash flows as of December 31, 2007, the Company concluded that
there is no indication of an impairment of the Company’s
TearLab™ technology
. Therefore,
no impairment charge was recorded during the year ended December 31,
2007.
9.
RESTRUCTURING CHARGES
In March 2006, the Company implemented a
number of structural and management changes designed to then support both the
continued development of its RHEO™ System and to execute its accelerated
diversification strategy within ophthalmology. In accordance with SFAS No. 146,
“Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS No.
146”), the Company recognized a total of $819,642 in restructuring charges
during the year ended December 31, 2006.
The restructuring charges of $819,642
recorded during the year ended December 31, 2006 consist solely of severance and
benefit costs related to the termination of a total of 12 employees at both the
Company’s Mississauga, Ontario and Palm Harbor, Florida offices. All severance
and benefit costs were fully paid as at December 31, 2006.
On
January 9, 2008, the Company announced the termination of employment of certain
members of its executive team in light of the Company’s current financial
situation and in connection with the indefinite suspension of its RHEO™ System
clinical development program and the sale of SOLX. In accordance with SFAS No.
146, the Company recognized a total of $1,312,721 in restructuring charges
during the year ended December 31, 2007. The total restructuring charges of
$1,312,721 recorded in
the year
ended December 31, 2007 consist solely of severance and benefit costs related to
the termination of a total of eight employees at both the Company’s Mississauga,
Ontario and Palm Harbor, Florida offices. All severance and benefit costs are
yet to be paid as at December 31, 2007.
10.
DISCONTINUED OPERATIONS
On
December 19, 2007, the Company sold to Solx Acquisition, and Solx Acquisition
purchased from the Company,
all of the issued and outstanding shares of
the capital stock of SOLX, which had been the Glaucoma Division of the Company
prior to the completion of this transaction. The consideration for the purchase
and sale of all of the issued and outstanding shares of the capital stock of
SOLX consisted of: (i) on the closing date of the sale, the
assumption by Solx Acquisition of all of the liabilities of the Company related
to SOLX’s business, incurred on or after December 1, 2007, and the Company’s
obligation to make a $5,000,000 payment to the former stockholders of SOLX due
on September 1, 2008 in satisfaction of the outstanding balance of the purchase
price of SOLX; (ii) on or prior to February 15, 2008, the payment by Solx
Acquisition of all of the expenses that the Company had paid to the closing
date, as they related to SOLX’s business during the period commencing on
December 1, 2007; (iii) during the period commencing on the closing date and
ending on the date on which SOLX achieves a positive cash flow, the payment by
Solx Acquisition of a royalty equal to 3% of the worldwide net sales of the SOLX
790 Laser and the SOLX Gold Shunt, including next-generation or future models or
versions of these products; and (iv) following the date on which SOLX achieves a
positive cash flow, the payment by Solx Acquisition of a royalty equal to 5% of
the worldwide net sales of these products. In order to secure the obligation of
Solx Acquisition to make these royalty payments, SOLX granted to the Company a
subordinated security interest in certain of its intellectual property.
No value was assigned to the
royalty payments as the determination of worldwide net sales of SOLX’s products
is subject to significant uncertainty.
The sale
transaction described above established fair values for certain of the Company’s
acquisition-related intangible assets and goodwill. Accordingly, the Company
performed an impairment test of these assets at December 1, 2007. Based on this
analysis, during the year ended December 31, 2007, the Company recognized a
non-cash goodwill impairment charge of $14,446,977 and an impairment charge of
$22,286,383 to record its acquisition-related intangible assets at their fair
value as of December 31, 2007
(notes 5 and 8)
.
The
Company’s results of operations related to discontinued operations for the years
ended December 31, 2007 and 2006 are as follows:
|
|
December
31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
244,150
|
|
|
|
31,625
|
|
Cost
of goods sold
|
|
|
|
|
|
|
|
|
Cost
of goods sold
|
|
|
119,147
|
|
|
|
11,053
|
|
Royalty
costs
|
|
|
26,277
|
|
|
|
8,332
|
|
Total
cost of goods sold
|
|
|
145,424
|
|
|
|
19,385
|
|
|
|
|
98,726
|
|
|
|
12,240
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
General
and administrative
(notes 11, 12 and
16)
|
|
|
3,630,943
|
|
|
|
1,378,536
|
|
Clinical
and regulatory
(notes 12
and 16)
|
|
|
2,828,686
|
|
|
|
754,624
|
|
Sales
and marketing
(notes 12
and 16)
|
|
|
818,301
|
|
|
|
330,210
|
|
Impairment
of goodwill
(note
5)
|
|
|
14,446,977
|
|
|
|
—
|
|
Impairment
of intangible assets
(note
8)
|
|
|
22,286,383
|
|
|
|
—
|
|
|
|
|
44,011,290
|
|
|
|
2,463,370
|
|
|
|
|
(43,912,564
|
)
|
|
|
(2,451,130
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
486
|
|
|
|
—
|
|
Interest
and accretion expense
|
|
|
(857,400
|
)
|
|
|
(273,192
|
)
|
Other
|
|
|
(9,302
|
)
|
|
|
(67
|
)
|
|
|
|
(866,216
|
)
|
|
|
(273,259
|
)
|
Loss
from discontinued operations before income taxes
|
|
|
(44,778,780
|
)
|
|
|
(2,724,389
|
)
|
Recovery
of income taxes
(note
13)
|
|
|
9,349,882
|
|
|
|
1,182,005
|
|
Loss
from discontinued operations
|
|
|
(35,428,898
|
)
|
|
|
(1,542,
384
|
)
|
The Company’s assets and liabilities
related to discontinued operations at December 31, 2006 are shown below. The
Company did not have any assets and liabilities related to discontinued
operations at December 31, 2007.
|
|
December
31, 2006
$
|
|
|
|
|
|
ASSETS
|
|
|
|
Current
|
|
|
|
Cash
and cash equivalents
|
|
|
35,462
|
|
Amounts
receivable
|
|
|
800
|
|
Inventory
|
|
|
371,099
|
|
Prepaid
expenses
|
|
|
131,593
|
|
Other
current assets
|
|
|
79,200
|
|
Total
current assets
|
|
|
618,154
|
|
Fixed
assets, net
(note
6)
|
|
|
286,407
|
|
Intangible
assets, net
(note
8)
|
|
|
28,806,667
|
|
Goodwill
(note
5)
|
|
|
14,446,977
|
|
|
|
|
44,158,205
|
|
|
|
|
|
|
LIABILITES
|
|
|
|
|
Current
|
|
|
|
|
Accounts
payable
|
|
|
232,687
|
|
Accrued
liabilities
(notes 12
and 14)
|
|
|
253,779
|
|
Total
current liabilities
|
|
|
486,466
|
|
Deferred
tax liability
(note
13)
|
|
|
11,087,750
|
|
|
|
|
11,574,216
|
|
11.
DUE TO STOCKHOLDERS
|
|
December
31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
|
|
|
|
|
|
Due
(from)/to
|
|
|
|
|
|
|
TLC
Vision Corporation
(note
12)
|
|
|
(2,708
|
)
|
|
|
91,884
|
|
Other
stockholders
(note
12)
|
|
|
35,522
|
|
|
|
60,522
|
|
|
|
|
32,814
|
|
|
|
152,406
|
|
The
balance due from and owing to TLC Vision Corporation (“TLC Vision”) is related
to computer and administrative support provided by TLC Vision, net of payments
made by the Company to TLC Vision. All amounts have been expensed during the
years ended December 31, 2007 and 2006, respectively, and included in general
and administrative expenses. The balance due to other stockholders includes
outstanding royalty fees payable to Mr. Hans Stock.
12.
RELATED PARTY TRANSACTIONS
The
following are the Company’s related party transactions in addition to those
disclosed in notes 10, 11 and 15.
One of
the Company’s primary customers had been RHEO Clinic Inc., a subsidiary of TLC
Vision. RHEO Clinic Inc. used the RHEO™ System to treat patients for which it
charged its customers (the patients) a per-treatment fee. During the third
quarter of 2005, RHEO Clinic Inc. determined that it would no longer treat
patients and subsequently sold certain of its assets to the Company at a
purchase price of C$61,812, including all applicable taxes. In connection with
that sale, the Company agreed to share equally in losses incurred by RHEO Clinic
Inc., to a maximum of C$28,952, for assets that RHEO Clinic Inc. was not able to
dispose of as of the agreed date, being December 31, 2005. On May 1, 2006, the
Company paid RHEO Clinic Inc. C$31,859 which included the amount owing for
losses incurred for the assets that RHEO Clinic Inc. was not able to dispose of
as of the agreed date.
(b)
|
TLC
Vision and Diamed
|
On June 25, 2003, the Company entered
into agreements with TLC Vision and Diamed to issue grid debentures in the
maximum aggregate principal amount of $12,000,000 in connection with the funding
of
the
Company’s
MIRA-1 and
related clinical trials. $7,000,000 of the aggregate principal amount was
convertible into shares of
the Company’s
common stock at a price of $0.98502 per
share, and $5,000,000 of the aggregate principal amount was
non-convertible.
The $5,000,000 portion of the
$12,000,000 commitment which was not convertible into
the Company’s
common stock was not advanced and the
commitment was terminated prior to the completion of
the Company’s
initial public offering of shares of
its common stock. During the years ended December 31, 2004 and 2003, the Company
issued grid debentures in an aggregate principal amount of $4,350,000 and
$2,650,000 to TLC Vision and Diamed, respectively, under the convertible portion
of the grid debentures. On December 8, 2004, as part of the corporate
reorganization relating to
the Company’s
initial public offering, the Company
issued 7,106,454 shares of its common stock to TLC Vision and Diamed, upon
conversion of $7,000,000 of aggregate principal amount of convertible debentures
at a conversion price of $0.98502 per share. Collectively, at
December 31
, 2007, the two companies have a
combined
35.6
% equity interest in the Company on a
fully diluted basis.
The Company entered into a
distributorship agreement (the “Distribution Agreement”), effective October 20,
2006, with Asahi Medical. The Distribution Agreement replaced the 2001
distributorship agreement between Asahi Medical and the Company, as supplemented
and amended by the 2003, 2004 and 2005 Memoranda.
Pursuant to the Distribut
ion
Agreement,
the Company
ha
d
distributorship rights to
Asahi
Medical
's Plasmaflo filter and
Asahi
Medical
's second
-
generation polysulfone Rheofilter
filter
on an exclusive basis in the United
States, Mexico and certain Caribbean countries
(collectively, “Territory 1-a”),
on an exclusive basis
in Canada,
on an exclusive basis
in
Colombia, Venezuela, New
Zealand
,
Australia
(collectively, “Territory 2”)
and on a non-exclusive
basis in Italy.
On
January 28, 2008, the Company disclosed that it was engaged in discussions with
Asahi Medical to terminate the Distribution Agreement. The Company and Asahi
Medical have entered into a termination agreement to terminate substantially all
of their obligations under the Distribution Agreement on and as of February 25,
2008 (the “Termination Agreement”). Pursuant to the Termination
Agreement, the Company and Asahi Medical have agreed to a mutual release of
claims relating to the Distribution Agreement, other than any claims relating to
certain provisions of the Distribution Agreement which survived its
termination.
The Company received free inventory from
Asahi Medical for purposes of the RHEO-AMD trial, the LEARN, or Long-term
Efficacy in AMD from Rheopheresis in
North America
, trials and related clinical studies.
The Company has accounted for this inventory at a value equivalent to the cost
the Company has paid for the same filters purchased from Asahi Medical for
purposes of commercial sales to
the Company’s
customers. The value of the free
inventory received from Asahi Medical was $384,660 and
nil
for the
years
ended
December 31
, 2007 and 2006,
respectively.
(d)
|
Mr. Hans Stock
(note
11)
|
On February 21, 2002, the Company
entered into an agreement with Mr. Stock as a result of his assistance in
procuring a distributor
ship
agreement for the filter products used
in the RHEO™ System from Asahi Medical. Mr. Stock agreed to further assist the
Company in procuring new product lines from Asahi Medical for marketing and
distribution by the Company. The agreement will remain effective for a term
consistent with the term of the distributorship agreement with Asahi Medical,
and Mr. Stock will receive a 5% royalty payment on the purchase of the filters
from Asahi Medical. During each of the year
s
ended December 31,
2007 and
2006, the Company
did not pay any amount to
Mr. Stock as royalty fees. Included in
due to stockholders at
December 31
, 2007
and
2006 is $48,022 and $48,022,
respectively, due to Mr. Stock.
On June 25, 2002, the Company entered
into a consulting agreement with Mr. Stock for the purpose of procuring a patent
license for the extracorporeal applications in ophthalmic diseases for that
period of time in which the patent was effective. Mr. Stock was entitled to 1.0%
of total net revenue from
the Company’s
commercial sales of products sold in
reliance and dependence upon the validity of the patent’s claims and rights in
the
United
States
. The Company agreed
to make advance consulting payments to Mr. Stock of $50,000 annually, payable on
a quarterly basis, to be credited against any and all future consulting payments
payable in accordance with this agreement. Due to the uncertainty of future
royalty payment requirements, all required payments to date have been
expensed.
On August 6, 2004, the Company entered
into a patent license and royalty agreement with Mr.
Stock to obtain an exclusive license to
U.S. Patent No. 6,245,038. The Company is required to make royalty payments
totaling 1.5% of product sales to Mr. Stock, subject to minimum advance royalty
payments of $12,500 per quarter. The advance payments are credited against
future royalty payments to be made in accordance with the agreement. This
agreement replaces the June 25, 2002 consulting agreement with Mr. Stock which
provided for a royalty payment of 1% of product sales. During
each of
the year
s
ended December 31,
2007 and
2006, the Company paid $50,000 to Mr.
Stock as royalty fees. Included in due to stockholders at December 31,
200
7 and 2006
is $12,500 and $12,500, respectively,
due to Mr. Stock.
On June 25, 2003, the Company entered
into a reimbursement agreement with Apheresis Technologies, Inc. (“ATI”)
pursuant to which employees of ATI, including Mr. John Cornish, one of
the Company’s
stockholders and its
former
Vice President, Operations,
provide
d
services to the Company and ATI is
reimbursed for the applicable percentage of time the employees spend working for
the Company. Effective April 1, 2005, the Company terminated its reimbursement
agreement with ATI, as a result of which termination the Company no longer
compensate
d
ATI in respect of any salary paid to,
or benefits provided to, Mr. Cornish by ATI. Until April 1, 2005, Mr. Cornish
did not have an employment contract with the Company and received no direct
compensation from the Company. On April 1, 2005, Mr. Cornish entered into an
employment agreement with the Company under which he received an annual base
salary of $106,450, representing compensation to him for devoting 80% of his
time to the business and affairs of the Company. Effective June 1, 2005, the
Company amended its employment agreement with Mr. Cornish such that he began to
receive an annual base salary of $116,723, representing compensation to him for
devoting 85% of his time to the business and affairs of the Company. Effective
April 13, 2006, the Company further amended its employment agreement with Mr.
Cornish such that his annual base salary was decreased to $68,660 in
consideration of his devoting 50% of his time to the business and affairs of the
Company.
I
n light of
the Company’s
current financial situation, and in
connection with the indefinite suspension of its RHEO
™
System clinical development program and
the sale of SOLX,
the
Company terminated the
employment
of Mr. Cornish effective January 4,
2008.
During the
year ended December 31
, 2007, ATI made available to the
Company, upon request, the services of certain of ATI’s employees and
consultants on a per diem basis. During the
year ended December 31
, 2007, the Company paid ATI
$
98,769
under this arrangement (2006 – nil).
Included in accounts payable and accrued liabilities at
December 31
, 2007 and 2006 is $
20,004
and $9,629, respectively, due to
ATI.
Effective January 1, 2004, the Company
entered into a rental agreement with Cornish Properties Corporation, a company
owned and managed by Mr. Cornish, pursuant to which the Company leases space
from Cornish Properties Corporation at $2,745 per month. The original term of
the lease extended to December 31, 2005. On November 8, 2005, as provided for in
the rental agreement, the Company extended the term of the rental agreement with
Cornish Properties Corporation for another year, ending December 31,
2006.
On December 19, 2006, the Company
extended the term of the rental agreement with Cornish Properties Corporation
for another year, ending December 31, 2007, at a lease payment of $2,168 per
month.
During
the
years ended December
31, 200
7
and 200
6
, the Company paid Cornish Properties
Corporation an amount of
$26,016 and
$32,940
, respectively,
as rent.
On November 30, 2006, the Company
announced that Mr. Elias Vamvakas, the Chairman, Chief Executive Officer and
Secretary of the Company, had agreed to provide the Company with a standby
commitment to purchase convertible debentures of the Company (“Convertible
Debentures”) in an aggregate maximum amount of $8,000,000 (the “Total Commitment
Amount”). Pursuant to the Summary of Terms and Conditions, executed
and delivered as of November 30, 2006 by the Company and Mr. Vamvakas, during
the 12-month commitment term commencing on November 30, 2006, upon no less than
45 days’ written notice by the Company to Mr. Vamvakas, Mr. Vamvakas was
obligated to purchase Convertible Debentures in the aggregate principal amount
specified in such written notice. A commitment fee of 200 basis points was
payable by the Company on the undrawn portion of the Total Commitment Amount.
Any Convertible Debentures purchased by Mr. Vamvakas would have carried an
interest rate of 10% per annum and would have been convertible, at Mr. Vamvakas’
option, into shares of
the
Company’s
common stock at a
conversion price of $2.70 per share. The Summary of Terms and Conditions further
provided that if the Company closes a financing with a third party, whether by
way of debt, equity or otherwise and there are no Convertible Debentures
outstanding, then the Total Commitment Amount was to be reduced automatically
upon the closing of the financing by the lesser of: (i) the Total Commitment
Amount; and (ii) the net proceeds of the financing. On February 6, 2007, the
Company raised gross proceeds in the amount of $10,016,000 in a private
placement of shares of its common stock and warrants. The Total Commitment
Amount was therefore reduced to zero, thus effectively terminating Mr. Vamvakas’
standby commitment. No portion of the standby commitment was ever drawn down by
the Company, and the Company paid Mr. Vamvakas a total of $29,808 in commitment
fees in February 2007.
The Company entered into a consultancy
and non-competition agreement on July 1, 2003 with the Center for Clinical
Research (“CCR”), then a significant s
tock
holder of the Company, which requires
the Company to pay a fee of $5,000 per month. For the year ended December 31,
2003, CCR agreed to forego the payment of $75,250 due to it in exchange for
options to purchase 20,926 shares of
the Company’s
common stock at an exercise price of
$0.13 per share. In addition, CCR agreed to the repayment of the balance of
$150,500 due to it at a rate of $7,500 per month beginning in July 2003. On
August 22, 2005, the Company amended the consultancy and non-competition
agreement with CCR such that the fee payable to it was increased from $5,000 to
$15,000 per month effective January 1, 2005. The monthly fee is fixed regardless
of actual time incurred by CCR in performance of the services rendered to the
Company. The agreement allows either party to convert the payment arrangement to
a fee of $2,500 daily. In the event of such conversion, CCR shall provide
services on a daily basis as required by the Company and will invoice the
Company for the total number of days that services were provided in that month.
The amended consultancy and non-competition agreement provides for the payment
of a one-time bonus of $200,000 upon receipt by the Company of FDA approval of
the RHEO™ System and the grant of 60,000 options to CCR at an exercise price of
$7.15 per share. The stockholders of the Company approved the adjustment of the
exercise price of these options to $2.05 per share on June 23, 2006. These
options were scheduled to vest as to 100% when and if the Company receives FDA
approval of the RHEO™ System on or before November 30, 2006, as to 80% when and
if the Company receives FDA approval after November 30, 2006 but on or before
January 31, 2007 and as to 60% when and if the Company receives FDA approval
after January 31, 2007. In August 2006, by letter agreement between the Company
and CCR, it was agreed that the monthly fee of $15,000 would be suspended at the
end of August 2006 until CCR’s services
are
required by the Company in
the future. This resulted in a
consulting expense,
included within clinical and regulatory expense for the
years ended December 31
, 2007 and 2006, of $
10,000
and $
125,000
, respectively.
On September 29, 2004, the Company
signed a product purchase agreement with Veris for its purchase from the Company
of 8,004 treatment sets over the period from October 2004 to December 2005, a
transaction valued at $6,003,000, after introductory rebates. However, due to
delays in opening its planned number of clinics throughout
Canada
, Veris no longer required the
contracted-for number of treatment sets in the period. The Company agreed to the
original pricing for the reduced number of treatment sets required in the
period. Dr. Jeffrey Machat, who is an investor in, and one of the directors of,
Veris, was a co-founder and former director of TLC Vision. In December 2005, by
letter agreement, the Company agreed to the volume and other terms for the
purchase and sale of treatment sets and pumps for the period ending February 28,
2006. As of December 31, 2005, the Company had received a total of $1,779,566
from Veris. Included in amounts receivable, net at December 31, 2005 was
$1,049,297 due from Veris for the purchase of additional pumps and treatment
sets. Veris agreed to the payment of interest at the rate of 8% per annum on all
amounts outstanding for more than 45 days up to March 31, 2006, the expected
date of final payment. In January 2006, the Company received from Veris an
interest payment of $4,495 on amounts outstanding for more than 45 days to
December 31, 2005. On February 3, 2006, the Company announced that the MIRA-1
clinical trial had not met its primary efficacy endpoint and that it would be
more likely than not that the Company will be required to conduct a follow-up
clinical trial of the RHEO™ System in order to support its Pre-Market Approval
application to the FDA. Because of this delay in being able to pursue
commercialization of the RHEO™ System in the
United States
and the resulting market reaction to
this news and based on discussions with Veris, the Company believed that Veris
would not be able to meet its financial obligations to the Company. Therefore,
during the year ended December 31, 2005, the Company recorded an allowance for
doubtful accounts of $1,049,297 against the amount due from Veris and did not
accrue additional interest on the amount outstanding during the year ended
December 31, 2006.
In April 2006, the Company agreed to
sell a total of 1,000 treatment sets, with a negotiated discount, to Veris at a
price of $200 per treatment set, which is lower than
the Company’s
cost. It was also agreed that payment
for the treatment sets must be received by the Company in advance of
shipment. In July 2006, Veris negotiated new payment terms with the
Company, and it was agreed that payment for treatment sets shipped subsequent to
June 2006 must be received within 60 days of shipment. The Company also agreed
that all sales of treatment sets made to Veris to the end of 2006 will remain at
the discounted price of $200 per treatment set. During the year ended December
31, 2006, the Company received a total of $171,800 from Veris for the purchase
of 1,207 treatment sets. The sale of the treatment sets was included in revenue
for the year ended December 31, 2006 as all the treatment sets had been
delivered to Veris. In November 2006, the Company sold 348 treatment sets to
Veris for $73,776, including applicable taxes, payment for which was not
received by the Company within the agreed 60-day credit period. The sale of
these treatment sets was not recognized as revenue during the year ended
December 31, 2006 as the Company believed that Veris would not be able to meet
its financial obligations to the Company. In January 2007, the Company met with
the management of Veris and agreed to forgive the outstanding amount receivable
of $73,776 for the purchase of 348 treatment sets delivered to Veris in November
2006. This amount was therefore not included in amounts receivable, net as of
December 31, 2006. In addition, the Company recorded an inventory loss of
$60,987 in the year ended December 31, 2006 for the sale of these 348 treatment
sets since these treatment sets had been delivered to Veris
already.
In June 2006, Veris returned four pumps
which had been sold to it in December 2005. In fiscal 2005, the Company had
recorded an inventory loss associated with all sales made to Veris in December
2005 and did not recognize revenue due to
the Company’s
anticipation that Veris may not return
the products shipped to it and would not be able to pay for the amounts
invoiced. Accordingly, during fiscal 2006, amounts receivable, net and the
allowance for doubtful account
s
recorded against the amount due from
Veris have been reduced by the invoiced amount for the four pumps of $143,520.
In addition, the cost of the four pumps returned by Veris, valued at $85,058,
was used to reduce the cost of goods sold in the period.
On November 6, 2006, the Company amended
its product purchase agreement with Veris and agreed to forgive the outstanding
amount receivable of $904,101 from Veris which had been owing for the purchase
of treatment sets and pumps and for related services delivered or provided to
Veris during the period from September 14, 2005 to December 31, 2005. In
consideration of the forgiveness of this debt, Veris agreed that the Company did
not owe Veris any amounts whatsoever in connection with (i) the use by the
Company of the leasehold premises located at 5280 Solar Drive in Mississauga,
Ontario or (ii) legal fees and expenses incurred by Veris prior to February 14,
2006 with respect to certain of Veris’ trademarks that had been assigned to the
Company, and licensed back to Veris, on February 14, 2006.
In March 2007, Veris negotiated new
payment terms with the Company, and it was agreed that payment for treatment
sets shipped subsequent to March 2007 must be received within 180 days of
shipment. During the
year
ended December 31
, 2007,
the Company sold a total of
816
treatment sets to Veris, for a total
amount of $
172,992
, plus applicable taxes. The sale of
these treatment sets was not recognized as revenue during the
year ended December 31, 2007
based on Veris’ payment history with
the Company and the new 180-day payment terms agreed by Veris and the Company.
In October 2007, the Company met with the management of Veris and
,
based on discussions with Veris, the
Company believes that Veris will not be able to meet its financial obligations
to the Company. Therefore, during the
year ended December 31
, 2007, the Company recorded an
allowance for doubtful accounts of $
172,992
against the total amount due from Veris
for the purchase of these treatment sets.
The Company also entered into a clinical
trial agreement on November 22, 2005 with Veris which required Veris to provide
certain clinical trial services to the Company. The agreement provided for an
advance payment of C$195,000 to Veris which represents 30% of the total value of
the contract. The Company paid Veris C$195,000 on November 22, 2005 as provided
for in the clinical trial agreement. This amount has been expensed during the
year ended December 31, 2005 as the Company has suspended the clinical trial in
question.
During the fourth quarter of 2004, the
Company began a business relationship with Innovasium Inc. Innovasium Inc.
designed and built some of
the Company’s
websites and also created some of the
sales and marketing materials to reflect the look of
the Company’s
websites. Daniel Hageman, who is the
President and one of the owners of Innovasium Inc., is the spouse of
a
former
officer of the Company. During the
years
ended December 31,
2007 and
2006, the Company paid Innovasium Inc.
C$
74,932 a
nd C$44,219, respectively. Included in
accounts payable and accrued liabilities at
December 31
, 2007
and
2006 is
nil
and nil, respectively, due to Innovasium
Inc. These amounts are expensed in the period incurred and paid when
due.
13.
INCOME TAXES
Significant
components of the Company’s deferred tax assets and liabilities are as
follows:
|
|
December
31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
|
|
|
|
|
|
Deferred
tax assets
|
|
|
|
|
|
|
Intangible
assets
|
|
|
144,644
|
|
|
|
85,855
|
|
Fixed
assets
|
|
|
50,902
|
|
|
|
(49,039
|
)
|
Stock
options
|
|
|
4,998,697
|
|
|
|
4,845,559
|
|
Accruals
and other
|
|
|
2,935,841
|
|
|
|
2,171,458
|
|
Capital
loss carry forward
|
|
|
12,801,402
|
|
|
|
-
|
|
Net
operating loss carry forwards
|
|
|
27,292,240
|
|
|
|
19,231,065
|
|
|
|
|
48,223,726
|
|
|
|
26,284,898
|
|
Valuation
allowance as previously reported
|
|
|
(45,915,455
|
)
|
|
|
(24,274,293
|
)
|
Timing
differences of VIE accounting on the valuation allowance
|
|
|
(133,597
|
)
|
|
|
—
|
|
Valuation
allowance as restated
|
|
|
(46,049,052
|
)
|
|
|
(24,274,293
|
)
|
Deferred
tax asset of continuing operations as restated
|
|
|
2,174,674
|
|
|
|
2,010,605
|
|
Deferred
tax asset of discontinued operations
|
|
|
—
|
|
|
|
773,395
|
|
|
|
|
2,174,674
|
|
|
|
2,784,000
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax liability of continuing operations as previously
stated
|
|
|
(2,308,271
|
)
|
|
|
(9,862,272
|
)
|
Adjustment
for the tax effect of VIE accounting on the change in the valuation of
intangible assets.
|
|
|
(2,125,751
|
)
|
|
|
(3,248,689
|
)
|
Deferred
tax liability of continuing operations as restated
|
|
|
(4,434,022
|
)
|
|
|
(13,110,961
|
)
|
Deferred
tax liability of discontinued operations
|
|
|
—
|
|
|
|
(11,861,145
|
)
|
|
|
|
(4,434,022
|
)
|
|
|
(24,972,106
|
)
|
|
|
|
|
|
|
|
|
|
Deferred
tax liability of continuing operations, net
|
|
|
(2,259,348
|
)
|
|
|
(11,100,356
|
)
|
Deferred
tax liability of discontinued operations, net
|
|
|
—
|
|
|
|
(11,087,750
|
)
|
The
following is a reconciliation of the recovery of income taxes between those that
are expected, based on substantively enacted tax rates and laws, to those
currently reported:
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
restated
note 2
|
|
|
restated
– notes 2 and 10
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from continuing operations before income taxes
|
|
|
(39,966,628
|
)
|
|
|
(83,595,303
|
)
|
|
|
(163,472,510
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
recovery of income taxes
|
|
|
(14,568,150
|
)
|
|
|
(30,281,154
|
)
|
|
|
(60,486,249
|
)
|
Goodwill
impairment
|
|
|
—
|
|
|
|
23,740,447
|
|
|
|
54,557,150
|
|
Non-controlling
interest
|
|
|
(524,871
|
)
|
|
|
(64,472
|
)
|
|
|
—
|
|
Stock-based
compensation
|
|
|
(677,699
|
)
|
|
|
55,117
|
|
|
|
38,628
|
|
Rate
change
|
|
|
—
|
|
|
|
322,321
|
|
|
|
12,923
|
|
Tax-free
income
|
|
|
—
|
|
|
|
(864
|
)
|
|
|
(46,979
|
)
|
Return
to provision
|
|
|
(35,270
|
)
|
|
|
(180,455
|
)
|
|
|
1,252,842
|
|
Non-deductible
expenses
|
|
|
252,519
|
|
|
|
89,360
|
|
|
|
19,656
|
|
Change
in valuation allowance
|
|
|
9,987,929
|
|
|
|
3,404,910
|
|
|
|
4,009,500
|
|
Recovery
of income taxes from continued operations
|
|
|
(5,565,542
|
)
|
|
|
(2,915,790
|
)
|
|
|
(642,529
|
)
|
Recovery
of income taxes from discontinued operations
|
|
|
(9,349,882
|
)
|
|
|
(1,182,005
|
)
|
|
|
—
|
|
Total
recovery of income taxes
|
|
|
14,915,425
|
|
|
|
(4,097,795
|
)
|
|
|
(642,529
|
)
|
The
Company and its subsidiaries have current and prior year losses available to
reduce taxable income and taxes payable in future years and, if these losses are
not utilized, they will expire as follows:
|
|
$
|
|
|
|
|
|
2012
|
|
|
3,455,029
|
|
2018
|
|
|
4,500,401
|
|
2019
|
|
|
1,893,700
|
|
2020
|
|
|
4,488,361
|
|
2021
|
|
|
3,356,992
|
|
2022
|
|
|
2,497,602
|
|
2023
|
|
|
1,901,399
|
|
2024
|
|
|
6,494,479
|
|
2025
|
|
|
12,985,677
|
|
2026
|
|
|
12,339,131
|
|
2027
|
|
|
21,451,150
|
|
14.
ACCRUED LIABILITIES
|
|
December
31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
|
|
|
|
|
Due
to professionals
|
|
|
475,044
|
|
|
|
688,619
|
|
Due
to clinical trial sites
|
|
|
136,681
|
|
|
|
110,798
|
|
Due
to clinical trial specialists
|
|
|
116,359
|
|
|
|
113,142
|
|
Product
development costs
|
|
|
277,521
|
|
|
|
124,312
|
|
Due
to employees and directors
|
|
|
66,804
|
|
|
|
418,682
|
|
Sales
tax and capital tax payable
|
|
|
26,820
|
|
|
|
12,394
|
|
Corporate
compliance
|
|
|
246,675
|
|
|
|
227,475
|
|
Interest
payable
|
|
|
—
|
|
|
|
10,758
|
|
Severances
|
|
|
1,312,721
|
|
|
|
—
|
|
Miscellaneous
|
|
|
214,826
|
|
|
|
130,978
|
|
|
|
|
2,873,451
|
|
|
|
1,837,158
|
|
|
|
|
|
|
|
|
|
|
Discontinued
operations
|
|
|
|
|
|
|
|
|
Due
to professionals
|
|
|
—
|
|
|
|
20,428
|
|
Due
to clinical trial sites
|
|
|
—
|
|
|
|
84,276
|
|
Due
to clinical trial specialists
|
|
|
—
|
|
|
|
93,500
|
|
Due
to employees and directors
|
|
|
—
|
|
|
|
45,464
|
|
Miscellaneous
|
|
|
—
|
|
|
|
10,111
|
|
|
|
|
—
|
|
|
|
253,779
|
|
As
previously discussed in; Note 2A OcuSense was determined to be a VIE and
OccuLogix was the primary beneficiary.
On
acquisition of OcuSense, FIN 46(R) requires that the non-controlling interest be
measured initially at fair value.
Minority
interest reflects the initial fair value of the minority’s 42.38% interest in
OcuSense’s net assets which are comprised of working capital and
intangible assets as at the November 30, 2006 acquisition date, less the
minority’s proportionate interest in losses incurred to date, plus the fair
value of all vested options and warrants issued to parties other than OccuLogix
as of the date of acquisition, as well as the value of options and warrants
vested and issued after the acquisition date.
In
addition, the Company has accounted for the milestone payments, made subsequent
to the acquisition date, as follows:
|
·
|
The
Company determined the fair value of the milestone payments on the date of
acquisition by incorporating the probability that the milestone payments
will be made, as well as the time value associated with the planned
settlement date of the payments.
|
|
·
|
Upon
payment of the milestone payments, the Company recorded the minority
interest portion of the change in fair value of the milestone payment
(i.e., the minority interest portion of the ultimate value of the
milestone payment less the initial fair value determination) as an
expense, with a corresponding increase to minority interest, to reflect
the additional value provided to the minority interest in excess of that
contemplated on the acquisition
date.
|
|
|
Years
Ended December 31
|
|
|
Cumulatively
|
|
|
|
2007
|
|
|
2006
|
|
|
from
November 30, 2006 date of acquisition
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Minority
interest at the beginning of period
|
|
|
6,110,834
|
|
|
|
6,256,451
|
|
|
|
6,256,451
|
|
Minority
share of loss from operations in the period
|
|
|
(1,312,178
|
)
|
|
|
(161,179
|
)
|
|
|
(1,473,357
|
)
|
Fair
value of stock-based compensation
|
|
|
155,304
|
|
|
|
15,562
|
|
|
|
170,866
|
|
Minority
interest at the end of period
|
|
|
4,953,960
|
|
|
|
6,110,834
|
|
|
|
4,953,960
|
|
16.
COMMITMENTS AND CONTINGENCIES
The
Company has commitments relating to operating leases for rental of office space
and equipment from unrelated parties. The total future minimum obligation under
the various leases is $197,374 for 2008. Rent paid under these leases was
$90,465, $80,329 and $60,207 for the years ended December 31, 2007, 2006 and
2005, respectively. All Canadian dollar amounts have been converted at the
year-end exchange rate.
In May
and June 2002, the Company entered into two separate agreements with Dr. Richard
Brunner and Mr. Stock, respectively, to obtain the exclusive license to U.S.
Patent No. 6,245,038. The Company is required to make royalty payments totaling
1.5% of product sales. The Company is required to make minimum advance quarterly
royalty payments of $25,000 and amounts credited against future royalty payments
to be made in accordance with the agreements. These agreements may be terminated
by the Company upon the first to occur of:
(a)
|
all
patents of the patent rights expiring, which is June
2017;
|
(b)
|
all
patent claims of the patent rights being invalidated;
or
|
(c)
|
the
introduction of a similar competing technology deployed in the United
States which could not be deterred by enforcement of the
patent.
|
On August
6, 2004, the Company entered into a patent license and royalty agreement with
Mr. Stock to obtain an exclusive license to U.S. Patent No. 6,245,038. The
Company is required to make royalty payments totaling 1.5% of product sales to
Mr. Stock, subject to minimum advance royalty payments of $12,500 per quarter.
The advance payments are credited against future royalty payments to be made in
accordance with the agreement. This agreement replaces the June 2002 consulting
agreement with Mr. Stock, which provided for a royalty payment of 1% of product
sales. This agreement effectively increases the total royalty payments required
to be made in respect of U.S. Patent No. 6,245,038 to 2% of product sales
(note 12).
Future
minimum royalty payments under the agreements as at December 31, 2007 are
approximately as follows:
|
|
$
|
|
2008
|
|
|
100,000
|
|
2009
|
|
|
100,000
|
|
2010
|
|
|
100,000
|
|
2011
|
|
|
100,000
|
|
2012
and thereafter
|
|
|
550,000
|
|
|
|
|
950,000
|
|
In
addition, the Company entered into a consultancy and non-competition agreement
on July 1, 2003 with CCR
(note
12)
, which requires the Company to pay a fee of $5,000 per month. On
August 22, 2005, the Company amended the consultancy and non-competition
agreement with CCR such that the fee payable was increased from $5,000 to
$15,000 per month effective January 1, 2005. The monthly fee is fixed regardless
of actual time incurred by CCR in performance of the services rendered to the
Company. The agreement allows either party to convert the payment arrangement to
a fee of $2,500 daily. In the event of such conversion, CCR shall provide
services on a daily basis as required by the Company and will invoice the
Company for the total number of days that services were provided in that month.
The amended consultancy and
non-competition agreement provides for the payment of a one-time bonus of
$200,000 upon receipt by the Company of FDA approval of the RHEO™ System and the
grant of 60,000 options to CCR at an exercise price of $7.15 per share. The
stockholders of the Company approved the adjustment of the exercise price of
these options to $2.05 per share on June 23, 2006
(
n
ote
17(e)
)
. These options were scheduled to vest
as to 100% when and if the Company receives FDA approval of the RHEO™ System on
or before November 30, 2006, as to 80% when and if the Company receives FDA
approval after November 30, 2006 but on or before January 31, 2007 and as to 60%
when and if the Company receives FDA approval after January 31, 2007. In August
2006, by letter agreement between the Company and CCR, it was agreed that the
monthly fee of $15,000 would be suspended at the end of August 2006 until CCR’s
services will be required by the Company in the future.
The future
minimum obligation under the consultancy and non-competition agreement for 2008
is therefore nil.
The
Company entered into consulting agreements with individual members of its
Scientific Advisory Board (“SAB”). The SAB was established in fiscal 2005 to
advise the Company on its continuing research and development activities. In
light of the Company’s financial position, on November 1, 2007, the Company
announced an indefinite suspension of the RHEO™ System clinical development
program for Dry AMD. That decision was made following a comprehensive
review of the respective costs and development timelines associated with the
products in the Company’s portfolio and, in particular, the fact that, if the
Company were unable to raise additional capital, it would not have had
sufficient cash to support its operations beyond early 2008. Accordingly, the
Company terminated its agreements with the individual members of the SAB
effective November 1, 2007. The future minimum obligation under the various
consulting agreements is therefore nil. Consulting fees paid amounted to
$218,929, $244,165 and nil for the years ended December 31, 2007, 2006 and 2005,
respectively.
On
November 30, 2006, pursuant to the Series A Preferred Stock Purchase Agreement
between the Company and OcuSense, the Company purchased 1,744,223 shares of
OcuSense’s Series A Preferred Stock representing 50.1% of OcuSense’s capital
stock on a fully diluted basis, 57.62% on an issued and outstanding
basis, for an aggregate purchase price of up to $8,000,000 (the
“Purchase Price”). On the closing of the purchase which took place on November
30, 2006, the Company paid $2,000,000 of the Purchase Price. The Company paid
another $2,000,000 installment of the Purchase Price on January 3, 2007. In June
2007, the Company paid the third $2,000,000 installment of the Purchase Price
upon the attainment by OcuSense of the first of two pre-defined milestones. The
Company is expected to pay the last $2,000,000 installment of the Purchase Price
upon the attainment by OcuSense of the second of such milestones, provided that
the milestone is achieved prior to May 1, 2009. The Series A Preferred Stock
Purchase Agreement also makes provision for an ability on the part of the
Company to increase its ownership interest in OcuSense for nominal consideration
if OcuSense fails to meet certain milestones by specified dates. In addition,
pursuant to the Series A Preferred Stock Purchase Agreement, the Company has
agreed to purchase $3,000,000 of shares of OcuSense’s Series B Preferred Stock,
which shall constitute 10% of OcuSense’s capital stock on a fully diluted basis
at the time of purchase, upon OcuSense’s receipt from the FDA of 510(k)
clearance for the TearLab™ test for DED and to purchase another $3,000,000 of
shares of OcuSense’s Series B Preferred Stock, which shall constitute an
additional 10% of OcuSense’s capital stock on a fully diluted basis at the time
of purchase, upon OcuSense’s receipt from the FDA of Clinical
Laboratory Improvement Amendments or CLIA, waiver for the TearLab™ test for DED
(note 4)
.
On April
4, 2007, the Company entered into an independent contractor services agreement
with Carol Jones for the purpose of providing consulting services for the
Company’s clinical trial activities. The agreement requires the Company to pay a
minimum fee of $1,750 per month during the period from April 4, 2007 to April 4,
2008. Future minimim obligation under the independent contractor services
agreement is $24,500 for 2008.
On
January 25, 2007, OcuSense entered into a consulting agreement with Dr. Michael
Lemp which requires the Company to pay a consulting fee of $8,333 per month.
Future minimim obligation under the consulting agreement is $100,000 for
2008.
On
February 1, 2007, OcuSense entered into a consulting agreement with Nancy Cahill
which requires the Company to pay a consulting fee of $1,000 per month. Future
minimim obligation under the consulting agreement is $12,000 for
2008.
On
September 17, 2007, OcuSense signed a letter of agreement with KAM
Communications for the purpose of providing marketing support for the future
launch of the TearLab™ test for DED which requires the Company to pay a monthly
fee of $2,398. Future minimum obligation under the agreement is $16,786 for
2008.
Contingencies
During
the ordinary course of business activities, the Company may be contingently
liable for litigation and a party to claims. Management believes that adequate
provisions have been made in the accounts where required. Although it is not
possible to estimate the extent of potential costs and losses, if any,
management believes that the ultimate resolution of any such contingencies will
not have a material adverse effect on the financial position and results of
operations of the Company.
Pursuant
to the terms of the distribution agreement with MeSys, dated January 1, 2002,
the Company undertook a commitment to purchase a minimum of 25 OctoNova pumps
yearly, beginning after receipt of FDA approval of the RHEO™ System,
representing an annual commitment of approximately $534,900. The marketing and
distributorship agreement with Diamed provides for a minimum purchase of 1,000
OctoNova pumps during the period from the date of the agreement until the end of
the five-year period following receipt of FDA approval, representing an
aggregate commitment of €16,219,000, or approximately $23,871,935, based on
exchange rates as of December 31, 2007. The Company is currently engaged in
discussions with Diamed and MeSys regarding the termination of its relationship
with each of them. Diamed is the designer, and MeSys is the
manufacturer, of the OctoNova pump, one of the key components of the RHEO™
System.
17.
CAPITAL STOCK
(a)
|
Authorized
share capital
|
The total
number of authorized shares of common stock of the Company is 75,000,000. Each
share of common stock has a par value of $0.001 per share. The total number of
authorized shares of preferred stock of the Company is 10,000,000. Each share of
preferred stock has a par value of $0.001 per share.
|
(i)
|
On
July 18, 2002, the Company’s former parent company, OccuLogix Corp. (“Old
OccuLogix”), merged with the Company, which was then a wholly-owned
subsidiary of Old OccuLogix, to form OccuLogix, Inc. Pursuant to the
merger, the Company effected a one-for-four stock split of its common and
convertible preferred stock pursuant to which each share of Old OccuLogix
common stock outstanding immediately prior to the merger was converted
into one-fourth of one fully paid and non-assessable share of the
Company’s common stock. Each outstanding share of Old OccuLogix Series A
preferred stock was converted into one-fourth of one fully paid and
non-assessable share of the Company’s Series A convertible preferred
stock.
|
At the
effective time of the merger, each outstanding warrant and option to purchase
common stock of Old OccuLogix was assumed by the Company and converted into a
warrant or option to purchase common stock of the Company, with appropriate
adjustments to the exercise price and number of shares for which such warrants
or options were exercisable.
|
(ii)
|
On
December 8, 2004, the Company consummated certain reorganization
transactions, which are collectively referred to as the “Reorganization”
and which consisted of the
following:
|
|
·
|
4,622,605
shares of common stock issued upon the automatic conversion of all
outstanding shares of Series A and Series B convertible preferred
stock;
|
|
·
|
7,106,454
shares of common stock issued to TLC Vision and Diamed upon conversion of
$7,000,000 aggregate principal amount of convertible grid debentures held
by them, the conversion price was $0.98502 per share;
and
|
|
·
|
19,070,234
shares of common stock issued to TLC Vision in connection with the
purchase by the Company of TLC Vision’s 50% interest in OccuLogix L.P.
(the “Partnership”), this amount included 1,281,858 shares of common stock
which were issued upon the exchange of shares of OccuLogix ExchangeCo ULC,
one of the Company’s Canadian subsidiaries, issued for tax purposes to TLC
Vision in connection with the Company’s purchase of TLC Vision’s interest
in the Partnership.
|
Following
the Reorganization, the Partnership’s U.S. business was carried on, and will
continue to be carried on, by OccuLogix LLC, a Delaware limited liability
company that is the Company’s wholly-owned, indirect subsidiary. The Partnership
carried on the Canadian business until December 31, 2005.
The
Company had licensed to the Partnership all of the distribution and marketing
rights for the RHEO
™
System for
ophthalmic indications to which it is entitled. Prior to the Reorganization, the
Company’s only profit stream came from its share of the Partnership’s earnings.
The Company’s acquisition of TLC Vision’s 50% ownership interest in the
Partnership, achieved through the Reorganization, moved the earnings potential
for sales of the RHEO
™
System to the
Company.
|
(iii)
|
On
December 31, 2005, the Partnership transferred all of its assets and
liabilities, and assigned its right to develop and sell the RHEO™ System,
to OccuLogix Canada Corp., a wholly-owned subsidiary of the Company.
Following the transfer, the Partnership’s Canadian business will be
carried on by OccuLogix Canada Corp. The Partnership and its general
partner have subsequently been wound
up.
|
(c)
|
Convertible
preferred stock
|
Convertible
preferred stockholders were entitled to one vote per share, on an “as-converted
to common stock” basis. Each share of Series A and Series B Convertible
Preferred Stock was entitled to receive a non-cumulative dividend of $0.411216
and $0.34698, respectively, prior to the payment of any dividend on common
stock. Each share of Series A and Series B Convertible Preferred Stock was
entitled to a liquidation preference of $4.836 and $3.5183, respectively, plus
any declared but unpaid dividend before any payment could be made to holders of
common stock.
After
giving effect to the anti-dilution adjustment resulting from the issuance of the
June 25, 2003 related party secured grid debentures
(note 12)
, each share of
Series A and Series B Convertible Preferred Stock was convertible into 1.678323
and 1.643683 shares of common stock, respectively, at the option of the holder.
Each share of Series A and Series B Convertible Preferred Stock would
automatically convert into shares of common stock at the conversion rate
previously described if the Company obtained a firm underwriting commitment for
an initial public offering. The conversion rate would be adjusted for stock
dividends, stock splits and other dilutive events. Shares of Series A and Series
B Convertible Preferred Stock would automatically convert in the event of sale
of all or substantially all of the assets or capital stock of the
Company.
In
December 2004, 5,600,000 shares of common stock of the Company at $12.00 per
share were issued in connection with the initial public offering for gross cash
proceeds of $67,200,000 (less issuance costs of $7,858,789).
On
September 1, 2006, the Company issued 8,399,983 shares of its common stock to
the former stockholders of SOLX in connection with the acquisition of SOLX. The
stock consideration was valued based on a per share price of $1.79, being the
weighted-average closing sale price of the Company’s
common stock as traded on NASDAQ over
the two-day trading period before and after August 1, 2006, being the date the
terms of the acquisition of SOLX were agreed to and announced
(note 4)
.
On
February 1, 2007, the Company entered into a Securities Purchase Agreement (the
“Securities Purchase Agreement”) with certain institutional investors, pursuant
to which the Company agreed to issue to those investors an aggregate of
6,677,333 shares of the Company’s common stock (the “Shares”) and five-year
warrants exercisable into an aggregate of 2,670,933 shares of the Company’s
common stock (the “Warrants”). The per share purchase price of the
Shares was $1.50, and the per share exercise price of the Warrants is $2.20,
subject to adjustment. The Warrants became exercisable on August 6,
2007. Pursuant to the Securities Purchase Agreement, on February 6, 2007, the
Company issued the Shares and the Warrants. The gross proceeds of the sale of
the Shares and the Warrants totaled $10,016,000 (less transaction costs of
$871,215). On February 6, 2007, the Company also issued to Cowen and Company,
LLC a five-year warrant exercisable into an aggregate of 93,483 shares of the
Company’s common stock (the “Cowen Warrant”) in part payment of the placement
fee payable to Cowen and Company, LLC for the services it had rendered as the
placement agent in connection with the sale of the Shares and the Warrants. All
of the terms and conditions of the Cowen Warrant (other than the number of
shares of the Company’s common stock into which the Cowen Warrant is
exercisable) are identical to those of the Warrants. The estimated grant date
fair value of the Cowen Warrant of $97,222 is included in the transaction costs
of $871,215
(note
17(f)).
As at
December 31, 2007, the number of shares of common stock of the Company reserved
for issuance upon the exercise of stock options is as follows:
Expiry
date
|
|
Range
of exercise prices
$
|
|
|
|
#
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2.05
|
|
|
|
25,000
|
|
2009
|
|
|
2.00
– 2.05
|
|
|
|
167,625
|
|
2010
|
|
|
2.00
– 2.05
|
|
|
|
119,375
|
|
2012
|
|
|
0.80
– 2.00
|
|
|
|
96,090
|
|
2013
|
|
|
0.99
– 1.30
|
|
|
|
1,079,798
|
|
2014
|
|
|
2.05
|
|
|
|
675,000
|
|
2015
|
|
|
2.05
|
|
|
|
949,500
|
|
2016
|
|
|
1.77
– 2.14
|
|
|
|
728,749
|
|
2017
|
|
|
1.11
– 1.82
|
|
|
|
946,250
|
|
|
|
|
|
|
|
|
4,787,387
|
|
The Company has a stock option plan, the
2002 Stock Option Plan (the “Stock Option Plan”)
,
which was most recently amended in June
2007 in order to, among other things, increase the share reserve under the Stock
Option Plan by 2,000,000. Under the Stock Option Plan, up to 6,456,000 options
are available for grant to employees, directors and consultants. Options granted
under the Stock Option Plan may be either incentive stock options or
non-statutory stock options. Under the terms of the Stock Option Plan, the
exercise price per share for an incentive stock option shall not be less than
the fair market value of a share of stock on the effective date of grant and the
exercise price per share for non-statutory stock options shall not be less than
85% of the fair market value of a share of stock on the date of grant. No option
granted to a holder of more than 10% of
the Company’s
common stock shall have an exercise
price per share less than 110% of the fair market value of a share of stock on
the effective date of grant.
Options granted may be time-based or
performance-based options. The vesting of performance-based options
is contingent upon meeting company-wide goals, including obtaining FDA approval
of the RHEO™ System and the achievement of a minimum amount of sales over a
specified period. Generally, options expire 10 years after the date of grant. No
incentive stock options granted to a 10% owner optionee shall be exercisable
after the expiration of five years after the effective date of grant of such
option, no option granted to a prospective employee, prospective consultant or
prospective director may become exercisable prior to the date on which such
person commences service, and with the exception of an option granted to an
officer, director or consultant, no option shall become exercisable at a rate
less than 20% per annum over a period of five years from the effective date of
grant of such option unless otherwise approved by the
Board.
The Company has also issued options
outside of the Stock Option Plan. These options were issued before the
establishment of the Stock Option Plan, when the authorized limit of the Stock
Option Plan was exceeded or as permitted under stock exchange rules when the
Company was recruiting executives. In addition, options issued to companies for
the purpose of settling amounts owing were issued outside of the Stock Option
Plan, as the Stock Option Plan prohibited the granting of options to companies.
The issuance of such options was approved by the Board and granted on terms and
conditions similar to those options issued under the Stock Option
Plan.
On January 1, 2006, the Company adopted
the provisions of SFAS No. 123R, “Share-Based Payments”, requiring the
recognition of expense related to the fair value of its stock-based compensation
awards. The Company elected to use the modified prospective transition method as
permitted by SFAS No. 123R and therefore has not restated its financial results
for prior periods. Under this transition method, stock-based compensation
expense for
each of
the
years ended December 31
, 2007
and 2006
includes compensation expense for all
stock-based compensation awards granted prior to, but not yet vested
,
as of January 1, 2006
,
based on the grant
-
date fair value estimated in accordance
with the original provisions of SFAS No. 123. Stock-based compensation expense
for all stock-based compensation awards granted subsequent to January 1, 2006
was based on the grant
-
date fair value estimated in accordance
with the provisions of SFAS No. 123R. The Company recognizes compensation
expense for stock option awards on a straight-line basis over the requisite
service period of the award.
The following table sets forth the total
stock-based compensation expense resulting from stock options included in the
Company’s consolidated statements of operations:
|
|
December
31,
|
|
|
|
2007
|
|
|
2006
(i)
|
|
|
2005
(ii)
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
65,660
|
|
|
|
1,396,609
|
|
|
|
170,576
|
|
Clinical
and regulatory
|
|
|
216,246
|
|
|
|
203,131
|
|
|
|
53,700
|
|
Sales
and marketing
|
|
|
199,065
|
|
|
|
527,303
|
|
|
|
500
|
|
Stock-based
compensation expense before income taxes
(iii)(iv)
|
|
|
480,971
|
|
|
|
2,127,043
|
|
|
|
224,776
|
|
(i)
|
At the annual meeting of
stockholders of the Company held on June 23, 2006, the stockholders of the
Company approved the re-pricing of all then out-of-the-money stock options
of the Company. Consequently, the exercise price of all
outstanding stock options of the Company that, on June 23, 2006, was
greater than $2.05, being the weighted
-
average trading price of
the
Company’s
common
stock on NASDAQ during the five-trading day period immediately preceding
June 23, 2006, was adjusted downward to $2.05. 2,585,000 of
the
Company’s
outstanding
stock options with a weighted
-
average exercise price of $8.42
were affected by the re-pricing. SFAS No. 123R requires the re-pricing of
equity awards to be treated as a modification of the original award and
provides that such a modification is an exchange of the original award for
a new award. SFAS No. 123R considers the modification to be the
repurchase of the old award for a new award of equal or greater value,
incurring additional compensation cost for any incremental
value. This incremental difference in value is measured as the
excess, if any, of the fair value of the modified award determined in
accordance with the provisions of SFAS No. 123R over the fair value of the
original award immediately before its terms are modified, measured based
on the share price and other pertinent factors at that
date. SFAS No. 123R provides that this incremental fair value,
plus the remaining unrecognized compensation cost from the original
measurement of the fair value of the old option, must be recognized over
the remaining vesting period. Of the 2,585,000 options affected by the
re-pricing, 1,401,073 were vested as at December 31,
2006. Therefore, additional compensation cost of $423,338 for
the 1,401,073 stock options that were vested has been recognized and is
included in the stock-based compensation expense for the year ended
December 31, 2006.
|
In accordance with SFAS No. 123R, the
Company also recorded compensation expense of $3,363 in the year ended December
31, 2006 as the Board approved accelerating the vesting of 1,250 unvested stock
options granted to a terminated employee on April 28, 2006. SFAS No.
123R treats such a modification as a cancellation of the original unvested award
and the grant of a new fully vested award as of that date.
(ii)
|
Stock-based compensation expense
for the year ended December 31, 2005 relates primarily to compensation
expense associated with non-employee stock options. The fair value of
these options was determined using the Black-Scholes option-pricing model
and was recorded in the Company’s consolidated statements of operations in
accordance with the provisions of SFAS No.
123.
|
On December 11, 2005, the Board approved
accelerating the vesting of unvested stock options granted prior to December 31,
2004 to employees, officers and directors. As a result of the vesting
acceleration, options to purchase 438,561 shares of
the Company’s
common stock became exercisable
immediately, including 308,611 held by executive officers, 48,958 held by
non-employee directors and 80,992 held by other employees. These accelerated
stock options represent approximately 30% of the total employee stock options of
the Company that would not have been vested as at December 31, 2005. The
weighted
-
average exercise price of the options
that were accelerated was $11.78. The purpose of the acceleration was to enable
the Company to avoid recognizing compensation expense associated with these
options of $1,532,203 and $1,466,253 during the years end
ed
December 31, 2006 and 2007,
respectively, in its consolidated statements of operations as a result of the
adoption of SFAS No. 123R on January 1, 2006. In accordance with
Accounting Principles Board Opinion No.
25, “Accounting for Stock Issued to Employees” (“APB No. 25”)
, the Company recorded a compensation
expense of $53,295 for the year ended December 31, 2005 as 9,033 of the total
options, of which the vesting was accelerated, were “in-the-money” as at the
date of the accelerated vesting. With respect to SFAS No. 123, the Company
recognized, for purposes of pro forma disclosures, the incremental increase in
fair value and the remaining balance of unrecognized compensation cost for the
affected options at the time of acceleration.
In accordance with APB No. 25, the
Company also recorded a compensation expense of $4,431 for the year ended
December 31, 2005 as certain performance-based options granted to an employee
and two directors were “in-the-money” as at December 31,
2005.
(iii)
|
The tax benefit associated with
the
Company’s
stock-based
compensation expense for the years ended December 31, 2007, 2006 and 2005
is $
964,644
, $
781,527
and nil, respectively.
This amount has not
been recognized in the Company’s consolidated financial statements for the
years ended December 31, 2007 and 2006 as there is a low probability that
the Company will realize this
benefit.
|
(iv)
|
Of the total stock-based
compensation expense of $480,971, $2,127,043 and $224,776 included in the
Company’s consolidated statements of operations for the years ended
December 31, 2007, 2006 and 2005, respectively, $72,800, $36,287 and nil
is included as stock-based compensation expense of discontinued operations
for the years ended December 31, 2007, 2006 and 2005,
respectively.
|
Net cash proceeds from the exercise of
common stock options were $2,228, $270,935 and $231,235 for the years ended
December 31, 2007, 2006 and 2005, respectively. No income tax benefit was
realized from stock option exercises during the years ended December 31, 2007,
2006 and 2005. In accordance with SFAS No. 123R, the Company presents excess tax
benefits from the exercise of stock options, if any, as financing cash flows
rather than operating cash flows.
Prior to the adoption of SFAS No. 123R,
the Company applied the provisions of SFAS No. 123, which allowed companies
either to expense the estimated fair value of employee stock options or to
follow the intrinsic value method as set forth in APB No. 25 but required
companies to disclose the pro forma effects on net loss as if the fair value of
the options had been expensed. The Company elected to apply APB No. 25 in
accounting for employee stock options. Therefore, as required by SFAS No. 123,
prior to the adoption of SFAS No. 123R, the Company provided pro forma net loss
and pro forma net loss per share disclosures for stock-based awards as if the
fair value of the options had been expensed.
The following table illustrates the pro
forma net loss and net loss per share of common stock as if the fair value
method had been applied to all awards during the year ended December 31,
2005:
|
|
$
|
|
|
|
|
|
Net loss, as
reported
|
|
|
(162,829,981
|
)
|
Adjustment for APB No.
25
|
|
|
57,726
|
|
Adjustment for SFAS No.
123
|
|
|
(6,664,395
|
)
|
Pro forma net
loss
|
|
|
(169,436,650
|
)
|
Pro forma net loss per share -
basic and diluted
|
|
|
(4.04
|
)
|
The weighted-average fair value of stock
options granted during the years ended December 31, 2007, 2006 and 2005 was
$0.90, $1.77 and $3.54, respectively. The estimated fair value was determined
using the Black-Scholes option-pricing model with the following weighted-average
assumptions:
|
Years ended December
31,
|
|
2007
|
2006
|
2005
|
|
|
|
|
Volatility
|
0.
765
|
0.901
|
0.728
|
Expected life of
options
|
5.85 years
|
5.56 years
|
2.33
years
|
Risk-free interest
rate
|
4.87%
|
4.83%
|
3.87%
|
Dividend
yield
|
0%
|
0%
|
0%
|
The Company’s computation of expected
volatility for the years ended December 31, 2007, 2006 and 2005
is based
on a comparable company’s historical stock prices as the Company did not have
sufficient historical data. The Company’s computation of expected life has been
estimated using the “short-cut approach” as provided in SAB No. 110 as options
granted by the Company meet the criteria of “plain vanilla” options as defined
in SAB No. 110. Under this approach, estimated life is calculated to be the
mid-point between the vesting date and the end of the contractual period. The
risk-free interest rate for an award is based on the U.S. Treasury yield curve
with a term equal to the expected life of the award on the date of
grant.
A summary of the options issued during
the year ended December 31, 2007 and the total number of options outstanding as
of that date and changes since December 31, 2004 are set forth
below:
|
|
Number of Options
Outstanding
|
|
|
Weighted
Average Exercise
Price
$
|
|
|
Weighted
Average Remaining Contractual Life
(years)
|
|
|
Aggregate Intrinsic
Value
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31,
2004
|
|
|
2,749,199
|
|
|
|
4.64
|
|
|
|
8.31
|
|
|
|
—
|
|
Granted
|
|
|
1,823,750
|
|
|
|
8.10
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(279,085
|
)
|
|
|
0.83
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(186,250
|
)
|
|
|
9.99
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31,
2005
|
|
|
4,107,614
|
|
|
|
1.75
|
|
|
|
8.20
|
|
|
|
—
|
|
Granted
|
|
|
890,000
|
|
|
|
1.99
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(140,726
|
)
|
|
|
1.93
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(619,667
|
)
|
|
|
2.05
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2006
(i)
|
|
|
4,237,221
|
|
|
|
1.75
|
|
|
|
7.61
|
|
|
|
—
|
|
Granted
|
|
|
1,077,500
|
|
|
|
1.31
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(2,250
|
)
|
|
|
0.99
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(525,084
|
)
|
|
|
1.83
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31,
2007
|
|
|
4,787,387
|
|
|
|
1.64
|
|
|
|
7.
4
1
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest,
December 31, 2007
|
|
|
3,
203,728
|
|
|
|
1.6
1
|
|
|
|
6.48
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, December 31,
2007
|
|
|
3,006,637
|
|
|
|
1.
61
|
|
|
|
6.
32
|
|
|
|
—
|
|
(i)
|
At the annual
meeting of stockholders of the
Company held on June 23, 2006, the stockholders of the Company approved
the re-pricing of all then out-of-the-money stock options of the
Company. Consequently, the exercise price of all outstanding
stock options of the Company that, on June 23, 2006, was greater than
$2.05, being the weighted average trading price of the Company’s common
stock on NASDAQ during the five-trading day period immediately preceding
June 23, 2006, was adjusted downward to
$2.05.
|
The aggregate intrinsic value in the
table above represents the total pre-tax intrinsic value (i.e., the difference
between the Company’s closing stock price on the last trading day of fiscal 2007
of $0.08 and the exercise price, multiplied by the number of shares that would
have been received by the option holders if the options had been exercised on
December 31, 2007). This amount is nil for all the years presented as the
exercise price of all options outstanding as at December 31, 2007, 2006, 2005
and 2004 is higher than $0.08, the Company’s closing stock price on the last
trading day of fiscal 2007.
As at December 31, 2007, $3,870,931 of
total unrecognized compensation cost related to stock options is expected to be
recognized over a weighted-average period of 1.85 years.
On February 6, 2007, pursuant to the
Securities Purchase Agreement between the Company and certain institutional
investors
(note
17
(d))
,
the Company issued the Warrants to
these investors. The Warrants are five-year warrants exercisable into an
aggregate of 2,670,933 shares of
the Company’s
common stock. On February 6, 2007, the
Company also issued the Cowen Warrant to Cowen and Company, LLC in part payment
of the placement fee payable to Cowen and Company, LLC for the services it had
rendered as the placement agent in connection with the private placement of the
Shares and the Warrants pursuant to the Securities Purchase Agreement. The Cowen
Warrant is a five-year warrant exercisable into an aggregate of 93,483 shares of
the Company’s
common stock. The per share exercise
price of the Warrants is $2.20, subject to adjustment, and the Warrants became
exercisable on August 6, 2007. All of the terms and conditions of the Cowen
Warrant (other than the number of shares of
the Company’s
common stock into which it is
exercisable) are identical to those of the Warrants.
The Company accounts for the Warrants
and the Cowen Warrant in accordance with the provisions of SFAS No. 133,
“Accounting for Derivative Instruments and Hedging Activities” (“SFAS No.
133”)
,
along with related interpretation EITF
No. 00-19
,
“Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock”
(“EITF No. 00-19”). SFAS No. 133 requires every derivative instrument within its
scope (including certain derivative instruments embedded in other contracts) to
be recorded on the balance sheet as either an asset or liability measured at its
fair value, with changes in the derivative’s fair value recognized currently in
earnings unless specific hedge accounting criteria are met. Based on the
provisions of EITF No. 00-19, the Company determined that the Warrants and the
Cowen Warrant do not meet the criteria for classification as equity.
Accordingly, the Company has classified the Warrants and the Cowen Warrant as a
current liability at
December
3
1
, 2007.
The estimated fair value of the Warrants
and the Cowen Warrant was determined using the Black-Scholes option-pricing
model with the following weighted-average assumptions:
|
|
|
|
|
Expected life of
w
arrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company initially allocated the
total proceeds received, pursuant to the Securities Purchase Agreement, to the
Shares and the Warrants based on their relative fair values. This resulted in an
allocation of $2,052,578 to obligation under warrants which includes the fair
value of the Cowen Warrant of $97,222.
In addition, SFAS No. 133 requires the
Company to record the outstanding derivatives at fair value at the end of each
reporting period, resulting in an adjustment to the recorded liability of the
derivative, with any gain or loss recorded in earnings of the applicable
reporting period. The Company therefore estimated the fair value of the Warrants
and the Cowen Warrant as at
December 31
, 2007 and determined the aggregate fair
value to be
a nominal
amount
, a decrease
of
approximately
$
2,052,578
over the initial measurement of the
aggregate fair value of the Warrants and the Cowen Warrant on the date of
issuance. Accordingly, the Company recognized a gain of $
2,052,578
in its consolidated statement of
operations for the
year
ended December 31
,
2007
which reflect
s
the decrease in
the Company’s
obligation to its warrant
holders
to its nominal
amount
at
December 31
, 2007.
Transaction costs associated with the
issuance of the Warrants of $170,081 has been recorded as a warrant expense in
the Company’s
consolidated statement of operations
for the
year ended December
31
,
2007.
A summary of the
w
arrants issued during the
year ended December 31
, 2007 and the total number of warrants
outstanding as of that date are set forth below:
|
|
Number of
w
arrants
o
utstanding
|
|
|
Weighted
a
verage
e
xercise
p
rice
|
|
|
|
|
|
|
|
|
Outstanding, December 31,
2006
|
|
|
—
|
|
|
|
—
|
|
|
|
|
2,764,416
|
|
|
|
2.20
|
|
Outstanding, December 31,
2007
|
|
|
2,764,416
|
|
|
|
2.20
|
|
18.
CONSOLIDATED STATEMENTS OF CASH FLOWS
The
net change in non-cash working capital balances related to operations consists
of the following:
|
|
Years
ended
December
31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
2005
$
|
|
|
|
|
|
|
|
|
|
|
|
Due
to related party
|
|
|
—
|
|
|
|
(5,065
|
)
|
|
|
13,291
|
|
Amounts
receivable
|
|
|
(58,782
|
)
|
|
|
390,634
|
|
|
|
(82,810
|
)
|
Inventory
|
|
|
2,756,759
|
|
|
|
2,250,554
|
|
|
|
(3,431,743
|
)
|
Prepaid
expenses
|
|
|
37,951
|
|
|
|
247,361
|
|
|
|
(322,455
|
)
|
Accounts
payable
|
|
|
797,415
|
|
|
|
(1,225,575
|
)
|
|
|
301,457
|
|
Accrued
liabilities
|
|
|
911,987
|
|
|
|
(1,155,335
|
)
|
|
|
(563,925
|
)
|
Deferred
revenue and rent inducement
|
|
|
—
|
|
|
|
—
|
|
|
|
(485,047
|
)
|
Due
to stockholders
|
|
|
(109,842
|
)
|
|
|
(5,827
|
)
|
|
|
(358,523
|
)
|
Other
current assets
|
|
|
7,000
|
|
|
|
12,781
|
|
|
|
4,105
|
|
|
|
|
4,342,488
|
|
|
|
509,528
|
|
|
|
(4,925,650
|
)
|
The
following table lists those items that have been excluded from the consolidated
statements of cash flows as they relate to non-cash transactions and additional
cash flow information:
|
|
Years
ended December 31,
|
|
|
|
2007
$
|
|
|
2006
$
|
|
|
2005
$
|
|
|
|
|
|
|
|
|
|
|
|
Free
inventory
|
|
|
418,303
|
|
|
|
(48,006
|
)
|
|
|
183,382
|
|
Warrant issued in part payment of
placement fee
|
|
|
97,222
|
|
|
|
―
|
|
|
|
—
|
|
Common
stock issued on acquisition
|
|
|
—
|
|
|
|
15,035,969
|
|
|
|
―
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
|
11,180
|
|
|
|
―
|
|
|
|
—
|
|
Income
taxes recovered (paid), net
|
|
|
—
|
|
|
|
4,533
|
|
|
|
(8,138
|
)
|
19. FINANCIAL
INSTRUMENTS
The
Company’s activities which result in exposure to fluctuations in foreign
currency exchange rates consist of the purchase of equipment from suppliers
billing in foreign currencies. The Company does not use derivative financial
instruments to reduce its currency risk.
The
Company’s financial instruments that are exposed to concentration of credit risk
consist primarily of cash and cash equivalents and amounts receivable. The
Company maintains its accounts for cash with large low credit risk financial
institutions in the United States and Canada in order to reduce its
exposure.
During
fiscal 2007, the Company derived all of its revenue from the sale of the
components of the RHEO™ System and the SOLX Glaucoma System prior to the sale of
all of the issued and outstanding shares of SOLX on December 19, 2007. During
the year ended December 31, 2007, the Company sold components of the RHEO™
System to one of its customers, Veris. As previously discussed in note 12, the
Company fully provided for the balance due from Veris. Accordingly, no trade
receivables due from Veris have been recognized as at December 31,
2007.
Fair
value of financial instruments
Fair
value of a financial instrument is defined as the amount at which the instrument
could be exchanged in a current transaction between willing parties. The
estimated fair values of cash and cash equivalents, amounts receivable, accounts
payable, accrued liabilities and amounts due from and to stockholders
approximate their carrying values due to the short-term maturities of these
instruments.
As at
December 31, 2007, the Company had investments in the aggregate principal amount
of $1,900,000 which consist of investments in four separate asset-backed auction
rate securities yielding an average return of 5.865% per
annum. However, as a result of market conditions, all of these
investments have recently failed to settle on their respective settlement dates
and have been reset to be settled at a future date with an average maturity of
46 days. Due to the current lack of liquidity for asset-backed
securities of this type, the Company has concluded that the carrying value of
these investments was higher than their fair value as of December 31, 2007.
Accordingly, these auction rate securities have been recorded at their estimated
fair value of $863,750. The Company considers this to be an other-than-temporary
reduction in the value. Accordingly, the loss associated with these auction rate
securities of $1,036,250 has been included as an impairment of investments in
the Company’s consolidated statement of operations for the year ended December
31, 2007. Although the Company continues to receive payment of interest earned
on these securities, the Company does not know at the present time when it will
be able to convert these investments into cash. Accordingly,
management has classified these investments as a non-current asset on its
consolidated balance sheet as of December 31, 2007. Management will continue to
closely monitor these investments for future indications of further impairment.
The illiquidity of these investments may have an adverse impact on the length of
time during which the Company currently expects to be able to sustain its
operations in the absence of an additional capital raise by the
Company.
20. SEGMENTED
INFORMATION
As a result of the acquisition of SOLX
and OcuSense during 2006
(
note
4
)
,
t
he Company had three reportable
segments: retina, glaucoma and point-of-care. The retina segment was in the
business of commercializing the
RHEO™ System which was used to perform
the Rheopheresis™ procedure, a procedure that selectively removes molecules from
plasma, which is designed to treat Dry AMD.
The Company began limited
commercialization of the RHEO™ System in
Canada
in 2003 and provided support to its
sole customer in
Canada
, Veris, in its commercial activities in
Canada
. The Company obtained investigational
device exemption clearance from the FDA to commence RHEO-AMD, its clinical study
of the
RHEO™ System.
O
n November 1, 2007, the
Company announced an indefinite suspension of the RHEO™ System clinical
development program for
Dry
AMD. That decision was made
following a comprehensive review of the respective costs and development
timelines associated with the products in
the Company’s
portfolio and, in particular, the fact
that, if the Company is unable to raise additional capital, it will not have
sufficient cash to support its operations beyond
approximately the end of
April
2008
(assuming that the outstanding
obligation of OccuLogix to pay $2,000,000 to OcuSense becomes due and payable
prior to the end of April 2008)
(note 4)
.
The glaucoma segment of the Company was
in the business of providing treatment for glaucoma with the use of the
components of the SOLX Glaucoma System which are used to provide physicians with
multiple options to manage intraocular pressure. The Company was seeking to
obtain 510(k) approval to market the components of the SOLX Glaucoma System in
the
United
States
. The Company
acquired the glaucoma segment in the acquisition of SOLX on September 1, 2006;
therefore, no amounts are shown for the segment in periods prior to September 1,
2006. On December 19, 2007, the Company sold
all of the issued and
outstanding shares of the capital stock of SOLX, which had been the glaucoma
segment of the Company prior to the completion of this sale. All revenue and
expenses related to the Company’s glaucoma segment, prior to the December 19,
2007 closing date, has therefore been included in discontinued operations
on its consolidated statements of
operations for the years ended December 31, 2007 and 2006
.
The point-of-care segment is made up of
the TearLab™ business which is currently developing technologies that enable eye
care practitioners to test, at the point-of-care, for highly sensitive and
specific biomarkers in tears using nanoliters of tear film. The Company acquired
the TearLab™ business in the acquisition of 50.1% of the capital stock of
OcuSense, on a fully diluted basis,
57.62% on an issued and outstanding
basis,
on November 30, 2006;
therefore, no amounts are shown in periods prior to November 30, 2006. During
the year ended December 31, 2006, the TearLab™ business did not meet the
quantitative criteria to be disclosed separately as a reportable segment and was
included as other.
The accounting policies of the segments
are the same as those described in significant accounting policies
(note 3)
. Intersegment sales and transfers are
minimal and are accounted for at current market prices, as if the sales or
transfers were to third parties.
The Company’s reportable units are
strategic business units that offer different products and services. They are
managed separately, because each business unit requires different technology and
marketing strategies. The Company’s business units are acquired or developed as
a unit, and in the case of SOLX and OcuSense, their respective management was
retained
at the time of
acquisition.
The Company’s business units are as
follows:
|
|
Retina
|
|
|
Glucoma
|
|
|
Point-of-care
|
|
|
Total
|
|
Year ended December 31,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Revenue
|
|
|
91,500
|
|
|
|
—
|
|
|
|
—
|
|
|
|
91,500
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
2,398,103
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,398,103
|
|
Operating
|
|
|
10,230,299
|
|
|
|
—
|
|
|
|
4,577,178
|
|
|
|
14,807,477
|
|
Depreciation and
amortization
|
|
|
2,065,088
|
|
|
|
—
|
|
|
|
1,320,851
|
|
|
|
3,385,939
|
|
Impairment of intangible
asset
|
|
|
20,923,028
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20,923,028
|
|
Restructuring
charges
|
|
|
1,312,721
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,312,721
|
|
Loss from continuing
operations
|
|
|
(36,837,739
|
)
|
|
|
—
|
|
|
|
(
5,898,029
|
)
|
|
|
(42,735,768
|
)
|
Interest
income
|
|
|
551,948
|
|
|
|
—
|
|
|
|
57,985
|
|
|
|
609,933
|
|
Interest
expense
|
|
|
(16,444
|
)
|
|
|
—
|
|
|
|
(784
|
)
|
|
|
(17,228
|
)
|
Changes in fair value of warrant
obligation
|
|
|
1,882,497
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,882,497
|
|
Loss on short-term
investment
|
|
|
(1,036,250
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,036,250
|
)
|
Other income (expense),
net
|
|
|
(6,547
|
)
|
|
|
—
|
|
|
|
24,557
|
|
|
|
18,010
|
|
Minority
interest
|
|
|
—
|
|
|
|
—
|
|
|
|
1,312,178
|
|
|
|
1,312,178
|
|
Recovery of income
taxes
|
|
|
3,186,334
|
|
|
|
—
|
|
|
|
2,379,208
|
|
|
|
5,565,542
|
|
Loss from continuing
operations
|
|
|
(32,276,201
|
)
|
|
|
—
|
|
|
|
(2,124,885
|
)
|
|
|
(34,401,086
|
)
|
Loss from discontinued
operations
|
|
|
—
|
|
|
|
(35,428,898
|
)
|
|
|
—
|
|
|
|
(35,428,898
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(32,276,201
|
)
|
|
|
(35,428,898
|
)
|
|
|
(2,124,885
|
)
|
|
|
(69,829,984
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
3,672,542
|
|
|
|
—
|
|
|
|
11,640,195
|
|
|
|
15,312,737
|
|
|
|
Retina
|
|
|
Glucoma
|
|
|
Point-of-care
|
|
|
Total
|
|
Year ended December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Revenue
|
|
|
174,259
|
|
|
|
—
|
|
|
|
—
|
|
|
|
174,259
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
3,528,951
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,528,951
|
|
Operating
|
|
|
12,741,701
|
|
|
|
—
|
|
|
|
312,393
|
|
|
|
13,054,094
|
|
Depreciation and
amortization
|
|
|
1,860,849
|
|
|
|
—
|
|
|
|
107,766
|
|
|
|
1,968,615
|
|
Impairment of
goodwill
|
|
|
65,945,686
|
|
|
|
—
|
|
|
|
—
|
|
|
|
65,945,686
|
|
Restructuring
charges
|
|
|
819,642
|
|
|
|
—
|
|
|
|
—
|
|
|
|
819,642
|
|
Loss from continuing
operations
|
|
|
(84,722,570
|
)
|
|
|
—
|
|
|
|
(420,159
|
)
|
|
|
(85,142,729
|
)
|
Interest
income
|
|
|
1,370,208
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,370,208
|
|
Interest
expense
|
|
|
(13,592
|
)
|
|
|
|
|
|
|
(1,304
|
)
|
|
|
(14,896
|
)
|
Other income (expense),
net
|
|
|
31,108
|
|
|
|
—
|
|
|
|
(173
|
)
|
|
|
30,935
|
|
Minority
interest
|
|
|
—
|
|
|
|
|
|
|
|
161,179
|
|
|
|
161,179
|
|
Recovery of income
taxes
|
|
|
2,814,058
|
|
|
|
—
|
|
|
|
101,732
|
|
|
|
2,915,790
|
|
Loss from continuing
operations
|
|
|
(80,520,788
|
)
|
|
|
—
|
|
|
|
(158,725
|
)
|
|
|
(80,679,513
|
)
|
Loss from discontinued
operations
|
|
|
—
|
|
|
|
(1,542,384
|
)
|
|
|
—
|
|
|
|
(1,542,384
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
year
|
|
|
(80,520,788
|
)
|
|
|
(1,542,384
|
)
|
|
|
(158,725
|
)
|
|
|
(82,221,897
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
38,762,773
|
|
|
|
44,158,205
|
|
|
|
15,604,440
|
|
|
|
98,525,418
|
|
|
|
Retina
|
|
|
Glucoma
|
|
|
Point-of-care
|
|
|
Total
|
|
Year ended December 31,
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
1,840,289
|
|
|
|
—
|
|
|
|
|
|
|
|
1,840,289
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
3,394,102
|
|
|
|
—
|
|
|
|
|
|
|
|
3,394,102
|
|
Operating
|
|
|
14,181,600
|
|
|
|
—
|
|
|
|
|
|
|
|
14,181,600
|
|
Depreciation and
amortization
|
|
|
1,821,680
|
|
|
|
—
|
|
|
|
|
|
|
|
1,821,680
|
|
Impairment of
goodwill
|
|
|
147,451,758
|
|
|
|
—
|
|
|
|
|
|
|
|
147,451,758
|
|
Loss from continuing
operations
|
|
|
(165,008,851
|
)
|
|
|
—
|
|
|
|
|
|
|
|
(165,008,851
|
)
|
Interest
income
|
|
|
1,593,366
|
|
|
|
—
|
|
|
|
|
|
|
|
1,593,366
|
|
Other expense,
net
|
|
|
(57,025
|
)
|
|
|
—
|
|
|
|
|
|
|
|
(57,025
|
)
|
Recovery of income
taxes
|
|
|
642,529
|
|
|
|
—
|
|
|
|
|
|
|
|
642,529
|
|
Net loss for the
year
|
|
|
(162,829,981
|
)
|
|
|
|
|
|
|
|
|
|
|
(162,829,981
|
)
|
Total
assets
|
|
|
137,806,058
|
|
|
|
—
|
|
|
|
|
|
|
|
137,806,058
|
|
The
Company’s geographic segments are as follows:
|
|
United
States
|
|
|
Canada
|
|
|
Europe
|
|
|
Israel
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
December 31,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed
assets
|
|
|
61,984
|
|
|
|
60,302
|
|
|
|
—
|
|
|
|
—
|
|
|
|
122,286
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed
assets
|
|
|
281,226
|
|
|
|
186,987
|
|
|
|
63,484
|
|
|
|
42,613
|
|
|
|
574,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed
assets
|
|
|
332,965
|
|
|
|
137,686
|
|
|
|
—
|
|
|
|
—
|
|
|
|
470,651
|
|
21.
SUBSEQUENT EVENTS
(i)
|
On
February 19, 2008, the Company announced that it had secured a bridge loan
in an aggregate principal amount of $3,000,000 (less transaction costs of
approximately $200,000) from a number of private parties. The loan bears
interest at a rate of 12% per annum and has a 180-day term, which may be
extended to 270 days under certain circumstances. The Company has pledged
its shares of the capital stock of OcuSense as collateral for the
loan.
|
Under the terms of the loan agreement,
the Company has two pre-payment options available to it, should it decide to not
wait until the maturity date to repay the loan. Under the first pre-payment
option, the Company may repay the loan in full by paying the lenders, in cash,
the amount of outstanding principal and accrued interest and issuing to the
lenders five-year warrants in an aggregate amount equal to approximately 19.9%
of the issued and outstanding share
s
of
the Company’s
common stock (but not to exceed 20% of
the issued and outstanding shares of
the Company’s
common stock). The warrants would be
exercisable into shares of
the Company’s
common stock at an exercise price of
$0.10 per share and would not become exercisable until the 180th day following
their issuance. Under the second pre-payment option, provided that the Company
has closed a private placement of shares of its common stock for aggregate gross
proceeds of at least $4,000,000, the Company may repay the loan in full by
issuing to the lenders shares of its common stock, in an aggregate amount equal
to the amount of outstanding principal and accrued interest, at a 15% discount
to the price paid by the private placement investors. Any exercise by the
Company of the second pre-payment option would be subject to stockholder and
regulatory approval.
(ii)
|
On
September 18, 2007, OccuLogix received a letter from The Nasdaq Stock
Market, or Nasdaq, indicating that, for the previous 30 consecutive
business days, the bid price of the Company’s common stock closed below
the minimum $1.00 per share requirement for continued inclusion under
Marketplace Rule 4450(e)(5), or the Minimum Bid Price Rule. Therefore, in
accordance with Marketplace Rule 4450(e)(2), the Company was provided 180
calendar days, or until March 17, 2008, to regain compliance. The Nasdaq
letter stated that, if, at any time before March 17, 2008, the bid price
of the Company’s common stock closes at $1.00 per share or more for a
minimum of 10 consecutive business days, Nasdaq staff will provide written
notification that it has achieved compliance with the Minimum Bid Price
Rule. The Nasdaq letter also stated that, if the Company does not regain
compliance with the Minimum Bid Price Rule by March 17, 2008, Nasdaq staff
will provide written notification that the Company’s securities will be
delisted, at which time the Company may appeal the Nasdaq staff’s
determination to delist its securities to a Nasdaq Listing Qualifications
Panel.
|
On February
1, 2008, the Company received a letter
from The Nasdaq Stock Market, or Nasdaq, indicating that, for the previous 30
consecutive trading days,
the Company’s
common stock did not maintain a minimum
market value of publicly held shares of $5,000,000 as required for continued
inclusion by Marketplace Rule 4450(a)(2), or the MVPHS Rule. Therefore, in
accordance with Marketplace Rule 4450(e)(1), the Company was provided 90
calendar days, or until May 1, 2008, to regain compliance. The Nasdaq letter
stated that, if
,
at any time before May 1, 2008, the
minimum market value of publicly held shares of
the Company’s
common stock is $5,000,000 or greater
for a minimum of 10 consecutive trading days, Nasdaq staff will provide written
notification that the Company complies with the MVPHS Rule. The Nasdaq letter
also stated that, if the Company does not regain compliance with the MVPHS Rule
by May 1, 2008, Nasdaq staff will provide written notification that
the Company’s
securities will be delisted, at which
time the Company may appeal the Nasdaq staff’s determination to delist its
securities to a Nasdaq Listing Qualifications Panel.
The Company will not have become
compliant with the Minimum Bid Price Rule by March 17, 2008. Although
the Company
intend
s
to appeal any determination by Nasdaq
staff to delist
its
common stock to a Nasdaq Listing
Qualifications Panel,
the
Company
may not be
successful in
its
appeal, in which case
its
common stock may be transferred to The
Nasdaq Capital Market or be delisted altogether. Should either occur, existing
stockholders will suffer decreased liquidity.
These Nasdaq notices have no effect on
the listing of
the
Company’s
common stock on
the Toronto Stock Exchange.
22. QUARTERLY
FINANCIAL DATA (UNAUDITED)
The
following tables contain selected unaudited consolidated statement of operations
data for each restated quarter of fiscal 2007 and 2006 set out in note
2A:
|
|
Fiscal 2007 Quarter
Ended
|
|
|
|
March 31
|
|
|
June 30
|
|
|
September
30
|
|
|
December 31
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
90,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,500
|
|
Gross profit
(loss)
|
|
|
57,900
|
|
|
|
(33,297
|
)
|
|
|
(2,287,411
|
)
|
|
|
(43,795
|
)
|
(Loss) from continuing operations
as previously
reported
|
|
|
(3,169,253
|
)
|
|
|
(1,497,313
|
)
|
|
|
(18,577,183
|
)
|
|
|
(9,466,667
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment
|
|
|
(313,018
|
)
|
|
|
(724,472
|
)
|
|
|
(1,752,744
|
)
|
|
|
1,099,565
|
|
(Loss) from
continuing operations as restated
|
|
|
(3,482,271
|
)
|
|
|
(2,221,785
|
)
|
|
|
(20,329,927
|
)
|
|
|
(8,367,102
|
)
|
(Loss) from discontinued
operations
|
|
|
(1,103,490
|
)
|
|
|
(1,081,559
|
)
|
|
|
(1,082,842
|
)
|
|
|
(32,161,007
|
)
|
Net (loss)
as previously
reported
|
|
|
(4,272,744
|
)
|
|
|
(2,578,871
|
)
|
|
|
(19,660,024
|
)
|
|
|
(41,627,675
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment
|
|
|
(313,018
|
)
|
|
|
(724,472
|
)
|
|
|
(1,752,744
|
)
|
|
|
1,099,565
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
- as
restated
|
|
|
(4,585,762
|
)
|
|
|
(3,303,343
|
)
|
|
|
(21,412,768
|
)
|
|
|
(40,528,110
|
)
|
Weighted average number of shares
outstanding basic and diluted
|
|
|
54,558,769
|
|
|
|
57,304,020
|
|
|
|
57,306,145
|
|
|
|
57,306,145
|
|
Net (loss) from continuing
operations per share basic and diluted
|
|
|
(0.06
|
)
|
|
|
(0.04
|
)
|
|
|
(0.35
|
)
|
|
|
(0.15
|
)
|
Net (loss) from discontinued
operations per share basic and diluted
|
|
|
(0.02
|
)
|
|
|
(0.02
|
)
|
|
|
(0.02
|
)
|
|
|
(0.56
|
)
|
Net (loss) per share basic and
diluted
|
|
|
(0.08
|
)
|
|
|
(0.06
|
)
|
|
|
(0.37
|
)
|
|
|
(0.71
|
)
|
|
|
Fiscal 2006 Quarter
Ended
|
|
|
|
March 31
|
|
|
June 30
|
|
|
September
30
|
|
|
December 31
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
—
|
|
|
|
82,715
|
|
|
|
53,144
|
|
|
|
38,400
|
|
Gross profit
(loss)
|
|
|
(1,650,000
|
)
|
|
|
78,398
|
|
|
|
(52,214
|
)
|
|
|
(1,730,876
|
)
|
(Loss) from continuing operations
as previously stated
|
|
|
(
5,806,868
|
)
|
|
|
(69,971,237
|
)
|
|
|
(3,033,234
|
)
|
|
|
(1,8
30
,
780
|
)
|
Adjustment
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(37,394
|
)
|
|
|
|
(
5,806,868
|
)
|
|
|
(69,971,237
|
)
|
|
|
(3,033,234
|
)
|
|
|
(1,8
68
,
174
|
)
|
(Loss) from discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
(531,771
|
)
|
|
|
(1,010,613
|
)
|
Net (loss) as previously
reported
|
|
|
(
5,806,868
|
)
|
|
|
(69,971,237
|
)
|
|
|
(3,565,005
|
)
|
|
|
(2,8
41
,
393
|
)
|
Adjustment
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(37,394
|
)
|
Net (loss) as
restated
|
|
|
(
5,806,868
|
)
|
|
|
(69,971,237
|
)
|
|
|
(3,565,005
|
)
|
|
|
(2,8
78
,
787
|
)
|
Weighted average number of shares
outstanding basic and diluted
|
|
|
42,166,561
|
|
|
|
42,186,579
|
|
|
|
44,911,018
|
|
|
|
50,622,496
|
|
Net (loss) from continuing
operations per share basic and diluted
|
|
|
(0.
14
|
)
|
|
|
(1.66
|
)
|
|
|
(0.07
|
)
|
|
|
(0.04
|
)
|
Net (loss) from discontinued
operations per share basic and diluted
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.01
|
)
|
|
|
(0.02
|
)
|
Net (loss) per share basic and
diluted
|
|
|
(0.14
|
)
|
|
|
(1.66
|
)
|
|
|
(0.08
|
)
|
|
|
(0.06
|
)
|
(i)
|
Loss from continuing operations
for the three months ended March 31, 2007 includes a charge for the change
in the fair value of the Company’s obligation under warrants and warrant
expense of $723,980.
|
(ii)
|
Loss from continuing operations
for the three months ended June 30, September 30 and December 31, 2007
includes income recognized from the change in the fair value of the
Company’s obligation under warrants of $1,500,710, $856,969 and $248,797,
respectively.
|
(iii)
|
Loss from continuing operations
for the three months ended December 31, 2007 includes a charge for the
loss on short-term investments of
$1,036,250.
|
(iv)
|
Loss from
continuing
operations for the three months
ended September 30, 2007, December 31, 2006 and March 31, 2006 includes
the expense of amounts related to inventory reserves of $
2,782,494
, $1,679,124 and $1,625,000,
respectively.
|
(v)
|
Loss from continuing operations
for the three months ended June 30, 2006 includes a goodwill impairment
charge of $65,945,686.
|
(vi)
|
Loss from discontinued operations
for the three months ended December 31, 2007 includes a goodwill
impairment charge of
$14,446,977.
|
(vii)
|
Loss from continuing operations
for the three months ended September 30, 2007 includes the charge for the
impairment of intangible assets of
$20,923,028.
|
(viii)
|
Loss from discontinued operations
for the three months ended December 31, 2007 includes the charge for the
impairment of intangible assets of
$22,286,383.
|
(ix)
|
Net loss per share basic and
diluted are computed independently for the quarters presented. Therefore,
the sum of the quarterly per share information may not be equal to the
annual per share
information.
|
ITEM
9.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE.
|
Not
applicable.
ITEM
9A. CONTROLS AND PROCEDURES.
Management’s
Consideration of the Restatement
Prior to
filing this Amended Report, the Company’s management, with the participation of
the Chief Executive Officer and Chief Financial Officer, reconsidered its
conclusions regarding the effectiveness of disclosure controls and procedures
and its internal control over financial reporting as at December 31, 2007 in
light of and giving consideration to the facts and circumstances of the
Restatement.
In
assessing whether the Company’s disclosure controls and procedures and the
Company’s internal control over financial reporting were effective as at
December 31, 2007, management also considered the impact of the Restatement of
its Financial Statements with respect to the method of consolidation used to
account for its investment in OcuSense, Inc., to the consolidated financial
statements for the fiscal years ended December 31, 2007 and 2006 as well as the
Company’s control environment.
Management
has concluded that due to the failure to account for the consolidation of
OcuSense, Inc. under the variable interest entity model since the Company’s
acquisition of OcuSense on November 30, 2006, there was a material weakness in
its internal control over financial reporting as of December 31,
2007.
Accordingly,
the Company’s management has concluded that the Company’s disclosure controls
and procedures and internal control over financial reporting were not effective
as of December 31, 2007.
During
the period subsequent to December 31, 2007, the Company underwent significant
changes, including the termination of employment of most of its employees,
including finance department employees and senior executives. Despite the
reduced resources at our disposal, using our remaining internal resources and
engaging the services of outside consultants, we have focused our efforts on
ensuring, to the fullest extent possible, that the Company has and maintains
appropriate design and operating effectiveness of internal control over
financial reporting. However, as is the case for many small companies, the
Company may not have the resources to address fully complex financial accounting
matters.
Disclosure
Controls and Procedures
The
Company maintains disclosure controls and procedures that are designed to ensure
that information required to be disclosed in the Company’s reports under the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded,
processed, summarized and reported within the time periods specified in the
Securities and Exchange Commission’s rules and forms, and that such information
is accumulated and communicated to the Company’s management, including its Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. Further, the design of a control system
must reflect the fact that there are resource constraints, and the benefit of
controls must be considered relative to their costs. In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls
and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and management
necessarily is required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. The Company’s disclosure
controls and procedures are designed to provide reasonable assurance of
achieving their desired objectives, and the Company’s Chief Executive Officer
and Chief Financial Officer have concluded that the Company’s disclosure
controls and procedures are not effective to provide that reasonable
assurance.
As of the
end of the period covered by the report, the Company carried out an evaluation,
under the supervision and with the participation of the Company’s management,
including the Company’s Chief Executive Officer and Chief Financial Officer, of
the effectiveness of the design and operation of the Company’s disclosure
controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act).
Based on that evaluation, the Company’s Chief Executive Officer and Chief
Financial Officer concluded that, as at December 31, 2007 the Company’s
disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange
Act) were not effective to provide reasonable assurance that the information
required to be disclosed in the reports the Company files and submits under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission’s rules and
forms.
There
have been no significant changes in the Company’s internal control over
financial reporting that occurred during the year ended December 31, 2007, that
have materially affected, or are reasonably likely to materially affect, the
Company’s internal control over financial reporting.
MANAGEMENT’S
REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Management
of the Company is responsible for establishing and maintaining effective
internal control over financial reporting as defined in Rule 13a-15(f) under the
Exchange Act. The Company’s internal control over financial reporting is
designed to provide reasonable assurance to the Company’s management and Board
of Directors regarding the preparation and fair presentation of published
financial statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Therefore, even those systems determined to be
effective can provide only reasonable assurance with respect to financial
statement preparation and presentation.
After the
Company filed its Annual Report on Form 10-K for the year ended December 31,
2007, the Company identified an error in its previously issued audited
consolidated financial statements and concluded that the financial statements
included in the Annual Report on Form 10-K should be restated, as discussed in
Note 2 to the consolidated financial statements included elsewhere in this
Amended Report. The Company determined that this error resulted from a
material weakness in the operating effectiveness of the Company’s internal
control over financial reporting relative to the method of consolidation of its
acquisition of OcuSense on November 30, 2006.
A
material weakness is a control deficiency, or a combination of control
deficiencies such that there is a reasonable possibility that a material
misstatement of the annual of interim financial statements will not be prevented
or detected.
As a
result of the deficiency described above, the Company’s management has revised
its earlier assessment and has now concluded that the Company had a material
weakness as at December 31, 2007 and, therefore, the Company’s internal control
over financial reporting was not effective as of such date.
The
framework on which such re-evaluation was based is contained in the report
entitled “Internal Control – Integrated Framework” issued by the Committee of
Sponsoring Organizations of the Treadway Commission (the “COSO”
Report”).
Management’s
revised assessment of the effectiveness of internal control over financial
reporting as of December 31, 2007, has been audited by Ernst & Young LLP, an
independent registered public accounting firm who also audited the Company’s
consolidated financial statements. As stated in the Report of Independent
Registered Public Accounting Firm on Internal Controls, they have amended
their opinion and now conclude that the Company has not maintained effective
internal control over financial reporting as of December 31, 2007.
REPORT
OF INDEPENDENT REGISTERED
PUBLIC
ACCOUNTING FIRM
The Board
of Directors and Shareholders of
OccuLogix, Inc.
We have
audited OccuLogix, Inc.’s internal control over financial reporting as of
December 31, 2007, based on criteria established in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). OccuLogix, Inc.’s management is
responsible for maintaining effective internal control over financial reporting,
and for its assessment of the effectiveness of internal control over financial
reporting included in the accompanying Management’s annual report on internal
control over financial reporting. Our responsibility is to express an
opinion on the Company’s internal control over financial reporting based on our
audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based
on the assessed risk and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the Company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In our
report dated March 14, 2008, we expressed an unqualified opinion on the
effectiveness of internal control over financial reporting. As
described in the following paragraph, the Company subsequently identified a
misstatement in its annual consolidated financial statements. Such
matter was considered to be a material weakness as further discussed in the
following paragraph. Accordingly, management has revised its
assessment about the effectiveness of the Company’s internal control over
financial reporting and our present opinion on the effectiveness of the
Company’s internal control over financial reporting as of December 31, 2007, as
expressed herein, is different from that expressed in our previous
report.
A
material weakness is a control deficiency, or combination of control
deficiencies, that results in more than a remote likelihood that a material
misstatement of the annual or interim financial statements will not be prevented
or detected. The following material weakness has been identified and
included in management’s assessment. In its assessment as of December
31, 2007, management has concluded that the controls in place relating to the
method of accounting for significant investments was not operating effectively
to provide reasonable assurance that the provisions of FASB Interpretation No.
46(R), “Consolidation of Variable Interest Entitles” (“FIN 46(R)”), Accounting
Research Bulletin No. 51, “Consolidated Financial Statements” and other
authoritative US generally accepted accounting principles literature related to
consolidation based on voting control would be properly applied, and that this
is a material weakness in internal control over financial
reporting. As a result, on July 18, 2008, the Company’s Board of
Directors approved the restatement of the Company’s previously issued
consolidated financial statements for the years ended December 31, 2007 and
2006. The restatement is described in note 2(a) to the consolidated
financial statements.
This
material weakness was considered in determining the nature, timing, and extent
of audit tests applied in our audit of the 2007 consolidated financial
statements, and this report does not affect our report dated March 14, 2008,
except for Note 2(a), as to which the date is July 18, 2008, on those
consolidated financial statements.
In our
opinion, because of the effect of the material weakness described above on the
achievement of the objectives of the control criteria,
OccuLogix, Inc.
did not
maintain effective internal control over financial reporting as of December 31,
2007 based on the COSO criteria.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of
OccuLogix, Inc.
as of December
31, 2007 and 2006, and the related consolidated statements of operations,
changes in stockholders’ equity and cash flows for each of the three years ended
December 31, 2007 and our report dated March 14, 2008, except for note 2A, as to
which the date is July 18, 2008, expressed an unqualified opinion
thereon.
Toronto,
Canada,
|
/s/
Ernst & Young LLP
|
March
14, 2008 (except for internal control over financial reporting related to
the material weakness described in the sixth paragraph above, as to which
the date is July 18, 2008).
|
Chartered
Accountants
Licensed
Public Accountants
|
ITEM
9B.
|
OTHER
INFORMATION.
|
None.
ITEM
10.
|
DIRECTORS
AND EXECUTIVE OFFICERS OF THE
REGISTRANT.
|
The
information required with respect to directors is incorporated herein by
reference to the information contained in the General Proxy Information for the
Company’s 2008 Annual Meeting of Stockholders (the “Proxy Statement”). The
information with respect to the Company’s audit committee financial expert is
incorporated herein by reference to the information contained in the sections
captioned “Appointment of Auditors” and “Audit Committee Report” of the Proxy
Statement.
Information
about the Company’s Code of Ethics appears under the heading “Code of Business
Conduct and Ethics” in the Proxy Statement. That portion of the Proxy Statement
is incorporated by reference into this report.
Information
about compliance with Section 16(a) of the Exchange Act appears under the
heading “Section 16(a) Beneficial Ownership Reporting Compliance” in the Proxy
Statement. That portion of the Proxy Statement is incorporated by reference into
this report.
ITEM
11.
|
EXECUTIVE
COMPENSATION.
|
Information
about compensation of the Company’s named executive officers appears under the
headings “Executive Officers” and “Information on Executive Compensation” in the
Proxy Statement. Information about compensation of the Company’s directors
appears under the heading “Compensation of Directors” in the Proxy Statement.
These portions of the Proxy Statement are incorporated by reference into this
report.
ITEM
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS.
|
Information
about security ownership of certain beneficial owners and management and
information regarding securities authorized for issuance under equity
compensation plans appears under the headings “Information on Executive
Compensation”, “Employee Benefit Plans” and “Principal Stockholders” in the
Proxy Statement. These portions of the Proxy Statement are incorporated by
reference to this report.
ITEM
13.
|
CERTAIN
RELATIONSHIPS AND RELATED PARTY
TRANSACTIONS.
|
Information
about certain relationships and related transactions appears under the heading
“Certain Relationships and Related Party Transactions” in the Proxy Statement.
That portion of the Proxy Statement is incorporated by reference into this
report.
ITEM
14.
|
PRINCIPAL
ACCOUNTANT FEES AND SERVICES.
|
Information
about the principal accountant fees and services as well as related pre-approval
policies and procedures appears under the headings “Appointment of Auditors” and
“Audit Committee Report” in the Proxy Statement. These portions of the Proxy
Statement are incorporated by reference into this report.
PART
IV
ITEM
15.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES.
|
(a)
|
The
following documents are filed as part of the
report:
|
|
(1)
|
Financial
Statements included in PART II of this
report:
|
Included
in PART II of this report:
|
Page
|
|
|
Report
of Independent Auditors
|
72
|
|
|
Consolidated
Balance Sheets as at December 31, 2007 and December 31,
2006
|
73
|
|
|
Consolidated
Statements of Operations for the three years ended December 31,
2007
|
74
|
|
|
Consolidated
Statements of Changes in Stockholders’ Equity for the three years ended
December 31, 2007
|
75
|
|
|
Consolidated
Statements of Cash Flows for the three years ended December 31,
2007
|
77
|
|
|
Notes
to Consolidated Financial Statements
|
78
|
|
(2)
|
Financial
Statement Schedules:
|
Schedule II – Valuation and Qualifying
Accounts and Reserves
Except as noted above, a
ll financial statement
schedules
for which
provisions have been made in the applicable accounting regulations of the
Commission
have been
omitted because they are inapplicable, not required by the instructions or
because the required information is either incorporated herein by reference or
included in the financial statements or notes thereto included in this
report.
The
exhibits required to be filed as part of this Annual Report on Form 10-K/A are
listed in the attached Index to Exhibits. Items 10.4, 10.5, 10.8 to 10.14
inclusive, 10.18, 10.24, 10.40, 10.44 to 10.49 inclusive and 10.52 to 10.57
inclusive in the attached Index to Exhibits are management contracts or
compensatory plans or arrangements.
The
exhibits required to be filed as part of this Annual Report on Form 10-K/A are
listed in the attached Index to Exhibits.
* * *
Copies of
the exhibits filed with this Annual Report on Form 10-K/A or incorporated by
reference herein do not accompany copies hereof for distribution to stockholders
of the Registrant. The Registrant will furnish a copy of any of such exhibits to
any stockholder requesting the same for a nominal charge to cover duplicating
costs.
POWER OF
ATTORNEY
The
registrant and each person whose signature appears below hereby appoint Elias
Vamvakas and William G. Dumencu as attorney-in-fact with full power of
substitution, severally, to execute in the name and on behalf of the registrant
and each such person, individually and in each capacity stated below, one or
more amendments to this Annual Report on Form 10-K/A, which amendments may make
such changes in this Annual Report as the attorney-in-fact acting in the
premises deems appropriate and to file any such amendments to this Annual Report
on Form 10-K/A with the Securities and Exchange Commission.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this Annual Report on Form 10-K/A to be
signed on its behalf by the undersigned thereunto duly authorized.
Dated:
August 27, 2008
|
OCCULOGIX,
INC
|
|
|
|
|
|
|
|
By:
|
/s/ Elias
Vamvakas*
|
|
|
|
|
|
Elias
Vamvakas
|
|
|
Chief Executive
Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Annual Report
on Form 10-K/A has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Dated: August
27, 2008
|
By:
|
/s/
Elias Vamvakas*
|
|
|
|
|
|
Elias
Vamvakas
|
|
|
Chief Executive Officer
and
|
|
|
Chairman of Board of
Directors
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/
William G. Dumencu
|
|
|
|
|
|
William G.
Dumencu
|
|
|
Chief Financial Officer and
Treasurer
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/
Jay T. Holmes*
|
|
|
|
|
|
Jay T.
Holmes
|
|
|
Director
|
|
|
|
|
|
|
Dated:
August 27, 2008
|
By:
|
/s/
Thomas N. Davidson*
|
|
|
|
|
|
Thomas N.
Davidson
|
|
|
Director
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/
Richard L. Lindstrom*
|
|
|
|
|
|
Richard L. Lindstrom,
M.D.
|
|
|
Director
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/ Georges
Noël*
|
|
|
|
|
|
Georges
Noël
|
|
|
Director
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/ Adrienne L.
Graves*
|
|
|
|
|
|
Adrienne L.
Graves
|
|
|
Director
|
|
|
|
|
|
|
Dated: August
27, 2008
|
By:
|
/s/ Gilbert S.
Omenn*
|
|
|
|
|
|
Gilbert S.
Omenn
|
|
|
Director
|
*
By
|
/s/ William G.
Dumencu
|
|
|
William G.
Dumencu
|
|
|
Attorney-in-fact
|
|
SCHEDULE
II
VALUATION
AND QUALIFYING ACCOUNTS AND RESERVES
|
|
Balance
at beginning of period
|
|
|
Charged
to costs and expenses
|
|
|
Charged
to other accounts
|
|
|
Deductions
|
|
|
Balance
at end of period
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bad
debt reserves
|
|
|
—
|
|
|
|
518,852
|
|
|
|
—
|
|
|
|
—
|
|
|
|
518,852
|
|
Inventory
reserves
|
|
|
—
|
|
|
|
1,990,830
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,990,830
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bad
debt reserves
|
|
|
518,852
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(518,852
|
)
|
|
|
—
|
|
Inventory
reserves
|
|
|
1,990,830
|
|
|
|
3,304,124
|
|
|
|
—
|
|
|
|
(193,560
|
)
|
|
|
5,101,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bad
debt reserves
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Inventory
reserves
|
|
|
5,101,394
|
|
|
|
2,790,209
|
|
|
|
—
|
|
|
|
(596,058
|
)
|
|
|
7,295,545
|
|
1.
|
During
fiscal 2006, OccuLogix, Inc. (“the Company”) agreed to forgive the amount
receivable from Veris Health Services Inc. (“Veris”) which had been owing
for products and related services delivered or provided to Veris during
the period from September 14, 2005 to December 31,
2005.
|
2.
|
During
fiscal 2007 and 2006, the Company utilized inventory that had previously
been provided for.
|
2.1
|
|
Form
of Plan of Reorganization (incorporated by reference to Exhibit 2.1 to the
Registrant’s Registration Statement on Form S-1/A No. 4, filed with the
Commission on December 6, 2004 (file no. 333-118024)).
|
|
|
|
3.1
|
|
Amended
and Restated Certificate of Incorporation of the Registrant as currently
in effect (incorporated by reference to Exhibit 10.4 to the Registrant’s
Registration Statement on Form S-1/A No. 3, filed with the Commission on
November 16, 2004 (file no. 333-118024)).
|
|
|
|
3.2
|
|
Amended
and Restated By-Laws of the Registrant as currently in effect
(incorporated by reference to Exhibit 10.4 to the Registrant’s
Registration Statement on Form S-1/A No. 3, filed with the Commission on
November 16, 2004 (file no. 333-118024)).
|
|
|
|
10.1
|
|
Amended
and Restated Marketing and Distribution Agreement dated October 25, 2004
between Diamed Medizintechnik GmbH and the Registrant (incorporated by
reference to Exhibit 10.6 to the Registrant’s Registration Statement on
Form S-1/A No. 1, filed with the Commission on October 7, 2004 (file no.
333-118024)).
|
|
|
|
10.2
|
|
Amended
and Restated Patent License and Royalty Agreement dated October 25, 2004
between the Registrant and Dr. Richard Brunner (incorporated by reference
to Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1/A
No. 1, filed with the Commission on October 7, 2004 (file no.
333-118024)).
|
|
|
|
10.3
|
|
Amended
and Restated Patent License and Royalty Agreement dated October 25, 2004
between the Registrant and Hans Stock (incorporated by reference to
Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1/A No.
1, filed with the Commission on October 7, 2004 (file no.
333-118024)).
|
|
|
|
10.4
|
|
Employment
Agreement between the Registrant and Elias Vamvakas dated September 1,
2004 (incorporated by reference to Exhibit 10.13 to the Registrant’s
Registration Statement on Form S-1/A No. 1, filed with the Commission on
October 7, 2004 (file no. 333-118024)).
|
|
|
|
10.5
|
|
Employment
Agreement between the Registrant and Thomas P. Reeves dated August 1, 2004
(incorporated by reference to Exhibit 10.14 to the Registrant’s
Registration Statement on Form S-1/A No. 1, filed with the Commission on
October 7, 2004 (file no. 333-118024)).
|
|
|
|
10.6
|
|
Rental
Agreement between the Registrant and Cornish Properties Corporation dated
January 1, 2004 (incorporated by reference to Exhibit 10.27 to the
Registrant’s Registration Statement on Form S-1/A No. 4, filed with the
Commission on December 6, 2004 (file no. 333-118024)).
|
|
|
|
10.7
|
|
Agreement
between the Registrant and Rheogenx Biosciences Corporation dated March
28, 2005 (incorporated by reference to Exhibit 10.2 to the Registrant’s
Quarterly Report on Form 10-Q, filed with the Commission on May 6, 2005
(file no. 000-51030)).
|
|
|
|
10.8
|
|
Amending
Agreement between the Registrant and Thomas P. Reeves, dated as of July 1,
2005, amending the Employment Agreement between the Registrant and Thomas
P. Reeves dated August 2004 (incorporated by reference to Exhibit 10.4 to
the Registrant’s Quarterly Report on Form 10-Q, filed with the Commission
on August 8, 2005 (file no. 000-51030)).
|
|
|
|
10.9
|
|
Option
Agreement between Steve Parks and the Registrant dated as of October 4,
2005 (incorporated by reference to Exhibit 10.4 to the Registrant’s
Quarterly Report on Form 10-Q, filed with the Commission on November 10,
2005 (file no. 000-51030)).
|
|
|
|
10.10
|
|
Release
Agreement between John Caloz and the Registrant, dated as of April 13,
2006, terminating the Employment Agreement between the Registrant and John
Caloz dated May 18, 2006 (incorporated by reference to Exhibit 10.2 to the
Registrant’s Quarterly Report on Form 10-Q, filed with the Commission on
May 10, 2006 (file no. 000-51030)).
|
10.11
|
|
Release
Agreement between Irving Siegel and the Registrant, dated as of April 13,
2006, terminating the Employment Agreement between the Registrant and
Irving Siegel dated as of August 3, 2003, as amended by the Amending
Agreement between the Registrant and Irving Siegel dated as of September
1, 2005 (incorporated by reference to Exhibit 10.3 to the Registrant’s
Quarterly Report on Form 10-Q, filed with the Commission on May 10, 2006
(file no. 000-51030)).
|
|
|
|
10.12
|
|
Termination
Agreement among the Registrant, AMD Medical Services Inc., Irving Siegel,
OccuLogix Canada Corp., Rheo Clinic Inc. and TLC Vision Corporation, dated
as of April 13, 2006, terminating, among other things, the Consulting
Agreement among the Registrant, AMD Medical Services Inc. and Irving
Siegel dated September 1, 2005 (incorporated by reference to Exhibit 10.4
to the Registrant’s Quarterly Report on Form 10-Q, filed with the
Commission on May 10, 2006 (file no. 000-51030)).
|
|
|
|
10.13
|
|
Amending
Agreement between the Registrant and Nozhat Choudry, dated as of April 1,
2006, amending the Employment Agreement between the Registrant and Nozhat
Choudry dated as of February 10, 2006 (incorporated by reference to
Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q, filed with
the Commission on May 10, 2006 (file no. 000-51030)).
|
|
|
|
10.14
|
|
Amending
Agreement between the Registrant and John Cornish, dated as of April 13,
2006, amending the Employment Agreement between the Registrant and John
Cornish dated as of April 1, 2005, as amended by the Amending Agreement
between the Registrant and John Cornish dated as of June 1, 2005
(incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly
Report on Form 10-Q, filed with the Commission on May 10, 2006 (file no.
000-51030)).
|
|
|
|
10.15
|
|
Convertible
Unsecured Promissory Note of Solx, Inc., dated April 1, 2006, in the
principal amount of $2,000,000 (incorporated by reference to Exhibit 10.8
to the Registrant’s Quarterly Report on Form 10-Q/A, filed with the
Commission on May 25, 2006 (file no. 000-51030)).
|
|
|
|
10.16
|
|
Agreement
and Plan of Merger, dated as of August 1, 2006, by and among the
Registrant, OccuLogix Mergeco, Inc., Solx, Inc. and Doug P. Adams, John
Sullivan and Peter M. Adams, acting, in each case, in his capacity as a
member of the Stockholder Representative Committee referred to therein
(incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly
Report on Form 10-Q, filed with the Commission on August 9, 2006 (file no.
000-51030)).
|
|
|
|
10.17
|
|
Convertible
Unsecured Promissory Note of Solx, Inc., dated August 1, 2006, in the
principal amount of $240,000 (incorporated by reference to Exhibit 10.2 to
the Registrant’s Quarterly Report on Form 10-Q, filed with the Commission
on August 9, 2006 (file no. 000-51030)).
|
|
|
|
10.18
|
|
Employment
Agreement between the Registrant and Doug P. Adams dated as of September
1, 2006 (incorporated by reference to Exhibit 10.41 to the Registrant’s
Annual Report on Form 10-K/A, filed with the Commission on March 29, 2007
(file no. 000-51030)).
|
|
|
|
10.19
|
|
Registration
Rights Agreement, dated as of September 1, 2006, among the Registrant,
Doug P. Adams, John Sullivan and Peter M. Adams, acting, in each case, in
his capacity as a member of the Stockholder Representative Committee
referred to in the Agreement and Plan of Merger, dated as of August 1,
2006, by and among the Registrant, OccuLogix Mergeco, Inc., Solx, Inc. and
Doug P. Adams, John Sullivan and Peter M. Adams, acting, in each case, in
his capacity as a member of the Stockholder Representative Committee
referred to therein (incorporated by reference to Exhibit 10.42 to the
Registrant’s Annual Report on Form 10-K/A, filed with the Commission on
March 29, 2007 (file no. 000-51030)).
|
|
|
|
10.20
|
|
2006
Distributorship Agreement between Asahi Kasei Medical Co., Ltd. and the
Registrant dated October 20, 2006 (incorporated by reference to Exhibit
10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed with the
Commission on November 9, 2006 (file no.
000-51030)).
|
10.21
|
|
Summary
of Terms and Conditions between the Registrant and Elias Vamvakas dated
November 30, 2006 (incorporated by reference to Exhibit 10.44 to the
Registrant’s Annual Report on Form 10-K/A, filed with the Commission on
March 29, 2007 (file no. 000-51030)).
|
|
|
|
10.22
|
|
Series
A Stock Purchase Agreement by and among OcuSense, Inc. and the Registrant
dated as of November 30, 2006 (incorporated by reference to Exhibit 10.45
to the Registrant’s Annual Report on Form 10-K/A, filed with the
Commission on March 29, 2007 (file no. 000-51030)). (Exhibits
have been omitted pursuant to Item 601(b)(2) of Regulation S-K and will be
provided to the Securities and Exchange Commission upon
request.)
|
|
|
|
10.23
|
|
Securities
Purchase Agreement, dated as of February 1, 2007, by and among the
Registrant and the investors listed on the Schedule of Investors attached
thereto as Exhibit A (incorporated by reference to Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K, filed with the Commission on
February 6, 2007 (file no. 000-51030)).
|
|
|
|
10.24
|
|
Employment
Agreement between the Registrant and Suh Kim dated as of March 12, 2007
(incorporated by reference to Exhibit 10.47 to the Registrant’s Annual
Report on Form 10-K/A, filed with the Commission on March 29, 2007 (file
no. 000-51030)).
|
|
|
|
10.25
|
|
License
Agreement between OcuSense, Inc. and The Regents of the University of
California dated March 12, 2003 (incorporated by reference to Exhibit
10.48 to the Registrant’s Annual Report on Form 10-K/A, filed with the
Commission on March 29, 2007 (file no. 000-51030)). (Portions
of this exhibit have been omitted pursuant to a request for confidential
treatment.)
|
|
|
|
10.26
|
|
Amendment
No. 1, dated June 9, 2003, to the License Agreement between OcuSense, Inc.
and The Regents of the University of California dated March 12, 2003
(incorporated by reference to Exhibit 10.49 to the Registrant’s Annual
Report on Form 10-K/A, filed with the Commission on March 29, 2007 (file
no. 000-51030)).
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10.27
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Amendment
No. 2, dated September 5, 2005, to the License Agreement between OcuSense,
Inc. and The Regents of the University of California dated March 12, 2003
(incorporated by reference to Exhibit 10.50 to the Registrant’s Annual
Report on Form 10-K/A, filed with the Commission on March 29, 2007 (file
no. 000-51030)). (Portions of this exhibit have been omitted
pursuant to a request for confidential treatment.)
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10.28
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Amendment
No. 3, dated July 7, 2006, to the License Agreement between OcuSense, Inc.
and The Regents of the University of California dated March 12, 2003
(incorporated by reference to Exhibit 10.51 to the Registrant’s Annual
Report on Form 10-K/A, filed with the Commission on March 29, 2007 (file
no. 000-51030)).
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10.29
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Amendment
No. 4, dated October 9, 2006, to the License Agreement between OcuSense,
Inc. and The Regents of the University of California dated March 12, 2003
(incorporated by reference to Exhibit 10.52 to the Registrant’s Annual
Report on Form 10-K/A, filed with the Commission on March 29, 2007 (file
no. 000-51030)).
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10.30
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Terms
of Business, dated February 5, 2007, between Invetech Pty Ltd and
OcuSense, Inc.
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10.31
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Amendment
No. 5, dated June 29, 2007, to the License Agreement between OcuSense,
Inc. and The Regents of the University of California dated March 12, 2003.
(Portions of this exhibit have been omitted pursuant to a request for
confidential treatment.)
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10.32
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Lease,
dated October 17, 2005, between Penyork Properties III Inc. and the
Registrant.
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10.33
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Lease
Amending Agreement, dated as of March 9, 2007, between the Registrant and
2600 Skymark Investments Inc., amending the Lease between Penyork
Properties III Inc. and the Registrant dated October 17,
2005.
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10.34
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2002
Stock Option Plan, as amended and restated on June 29,
2007.
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10.35
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Manufacturing
and Development Agreement, dated October 25, 2007, between MiniFAB (Aust)
Pty Ltd and OcuSense, Inc. (Portions of this exhibit have been
omitted pursuant to a request for confidential
treatment.)
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10.36
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First
Amendment to Series A Preferred Stock Purchase Agreement, dated October
29, 2007, between OcuSense, Inc. and the Registrant (incorporated by
reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form
10-Q, filed with the Commission on November 9, 2007 (file no.
000-51030)).
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10.37
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Research
Agreement, dated as of December 13, 2007, between
*
and OcuSense, Inc.
(Portions of this exhibit have been omitted pursuant to a request for
confidential treatment.)
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10.38
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Stock
Purchase Agreement, dated as of December 19, 2007, between the Registrant
and Solx Acquisition, Inc. (Exhibits have been omitted pursuant
to Item 601(b)(2) of Regulation S-K and will be provided to the Commission
upon request.)
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10.39
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Amending
Agreement, dated as of December 19, 2007, by and among the Registrant,
Solx, Inc. and Peter M. Adams, acting for and on behalf of the Stockholder
Representative Committee, amending the Agreement and Plan of Merger, dated
as of August 1, 2006, by and among the Registrant, OccuLogix Mergeco,
Inc., Solx, Inc. and Doug P. Adams, John Sullivan and Peter M. Adams,
acting in each case, in his capacity as a member of the Stockholder
Representative Committee referred to therein.
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10.40
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Termination
Agreement, dated as of December 19, 2007, between Doug P. Adams and the
Registrant, terminating the Employment Agreement between the Registrant
and Doug P. Adams dated as of September 1, 2006.
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10.41
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Limited
Guaranty, dated as of December 19, 2007, by Doug P. Adams for the benefit
of the Registrant.
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10.42
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Security
Agreement, dated as of December 19, 2007, by Solx, Inc. in favor of the
Registrant.
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10.43
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Letter
Agreement, dated December 20, 2007, between the Registrant and Solx
Acquisition, Inc.
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10.44
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Termination
Agreement, dated as of January 4, 2008, between John Cornish and the
Registrant, terminating the Employment Agreement between the Registrant
and John Cornish dated as of April 1, 2005, as amended.
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10.45
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Termination
Agreement, dated as of January 4, 2008, between Julie Fotheringham and the
Registrant, terminating the Employment Agreement between the Registrant
and Julie Fotheringham dated September 1, 2004.
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10.46
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Termination
Agreement, dated as of January 4, 2008, between Stephen Parks and the
Registrant, terminating the Employment Agreement between Stephen Parks and
the Registrant dated as of October 4, 2005.
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10.47
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Termination
Agreement, dated as of January 8, 2008, between David C. Eldridge and the
Registrant, terminating the Employment Agreement between the Registrant
and Dr. David Eldridge dated November 9, 2004.
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10.48
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Termination
Agreement, dated as of January 31, 2008, between Nozhat Choudry and the
Registrant, terminating the Employment Agreement between Nozhat Choudry
and the Registrant, as amended.
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10.49
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Termination
Agreement, dated as of January 31, 2008, between Stephen Kilmer and the
Registrant, terminating the Employment Agreement between the Registrant
and Stephen Kilmer dated July 30, 2004.
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10.50
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Loan
Agreement, dated as of February 19, 2008, by and among the Registrant, the
Lenders named therein and Marchant Securities Inc.
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10.51
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Share
Pledge Agreement, dated as of February 19, 2008, by the Registrant in
favor of Marchant Securities Inc., as collateral agent.
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10.52
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Employment
Agreement, dated as of February 25, 2008, between the Registrant and
William G. Dumencu.
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10.53
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Termination
Agreement, dated as of February 25, 2008, between Asahi Kasei Kuraray
Medical Co., Ltd. and the registrant.
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10.54
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Amending
Agreement, dated as of March 3, 2008, between Nozhat Choudry and the
Registrant, amending the Termination Agreement between Nozhat Choudry and
the Registrant dated as of January 31, 2008.
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10.55
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Amending
Agreement, dated as of March 3, 2008, between John Cornish and the
Registrant, amending the Termination Agreement between John Cornish and
the Registrant dated as of January 4, 2008.
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10.56
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Amending
Agreement, dated as of March 3, 2008, between David C. Eldridge and the
Registrant, amending the Termination Agreement between David C. Eldridge
and the Registrant dated as of January 8, 2008.
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10.57
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Amending
Agreement, dated as of March 3, 2008, between Julie Fotheringham and the
Registrant, amending the Termination Agreement between Julie Fotheringham
and the Registrant dated as of January 4, 2008.
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10.58
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Amending
Agreement, dated as of March 3, 2008, between Stephen Parks and the
Registrant, amending the Termination Agreement between Stephen Parks and
the Registrant dated as of January 4, 2008.
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14.1
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Code
of Conduct of the Registrant (incorporated by reference to Exhibit 14.1 to
the Registrant’s Quarterly Report on Form 10-Q, filed with the Commission
on November 10, 2005 (file no. 000-51030)).
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14.2
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Complaint
and Reporting Procedures of the Registrant (incorporated by reference to
Exhibit 14.2 to the Registrant’s Quarterly Report on Form 10-Q, filed with
the Commission on August 8, 2005 (file no. 000-51030)).
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21.1
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Subsidiaries
of Registrant (incorporated by reference to Exhibit 21.1 to the
Registrant’s Registration Statement on Form S-1/A No. 1, filed with the
Commission on October 7, 2004 (file no. 333-118024)).
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Consent
of Ernst & Young LLP.
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24.1
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Power
of Attorney (included on signature page).
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CEO’s
Certification required by Rule 13A-14(a) of the Securities Exchange Act of
1934.
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CFO’s
Certification required by Rule 13A-14(a) of the Securities Exchange Act of
1934.
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CEO’s
Certification of periodic financial reports pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.
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CFO’s
Certification of periodic financial reports pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, U.S.C. Section
1350.
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