IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company") today
announced financial results for its fiscal year ended December 31,
2013 and provided an update on operational developments. All
amounts are in U.S. Dollars, unless otherwise stated.
"2013 was a challenging and exciting year for IntelGenx," said
Rajiv Khosla, President and CEO of IntelGenx. "We made significant
progress with the filing of the NDA for our anti-migraine film and
the subsequent filing of an ANDA by our partner, Par
Pharmaceutical, for our opioid dependence film. Also, subsequent to
the end of the year, in early January, we reached agreement with
Par for the development of another two products. One of the
challenges throughout 2013 was the disappointing sales performance
of Forfivo XL®, our high strength anti-depressant tablet. We
continue to work together with Edgemont Pharmaceuticals, our
commercialization partner for this product, to address the Forfivo
XL® business. At the corporate-level we successfully completed a
public offering in December, raising net funds of $3.0 million,
which strengthened our cash position at December 31, 2013 to $5.0
million. These funds will enable us to move forward with the next
important phase of our development, which is to expand into a new
facility and establish a pilot plant for VersaFilm™ manufacturing,
whilst continuing to further our product portfolio."
Corporate Development Update
Product-related
Anti-depressant tablet, Forfivo XL®
Forfivo XL®, our first FDA approved product, was launched in
October 2012 and is being marketed in the United States under the
terms of a license agreement between us and Edgemont
Pharmaceuticals. Forfivo XL® is indicated for the treatment of
Major Depressive Disorder ("MDD") and is the only extended-release
bupropion HCl product to provide a once-daily, 450mg dose in a
single tablet. The active ingredient in Forfivo XL® is bupropion,
the same active ingredient used in the well-known antidepressant
product Wellbutrin XL®. Prior to the launch of Forfivo XL®, most
patients in the US requiring a 450mg dose of bupropion had been
taking multiple tablets to achieve their 450mg dose requirement.
With Forfivo XL® now available in the US, these patients can
simplify their dosing regimen to a single Forfivo XL tablet,
once-daily.
The commercialization of Forfivo XL® triggered launch-related
milestone payments to us of up to $4.0 million, of which $1 million
was received in Q1, 2013, and additional milestones upon achieving
certain sales and exclusivity targets of up to a further $23.5
million. We also receive tiered, double-digit, royalties on net
sales of Forfivo XL®. We recorded total revenue for Forfivo in 2013
of approximately $492 thousand.
In August, 2013 we announced receipt of a Paragraph IV
Certification Letter from Wockhardt Bio AG, advising of the
submission of an ANDA to the FDA requesting authorization to
manufacture and market generic versions of Forfivo XL® 450 mg
capsules in the United States. We intend to vigorously enforce our
intellectual property rights for Forfivo XL® and will pursue all
available legal and regulatory pathways in defense of the product,
which is currently protected by an issued patent listed in the
FDA's Approved Drug Products List (Orange Book).
Anti-migraine Film
In March, 2013 we submitted a 505(b)(2) NDA to the FDA for our
novel oral thin-film formulation of Rizatriptan, the active drug in
Maxalt-MLT® orally disintegrating tablets. Maxalt-MLT® is a leading
branded anti-migraine product manufactured by Merck & Co. The
thin-film formulation of Rizatriptan was developed in accordance
with the co-development and commercialization agreement with
RedHill Biopharma Ltd. using IntelGenx' proprietary immediate
release VersaFilm™ oral drug delivery technology. In December 2011,
we received approval by Health Canada to conduct a pivotal
bioequivalence study to determine if our product is safe and
bioequivalent with the FDA approved reference product, Maxalt-MLT®.
The trial was conducted in the second quarter of 2012 and was a
randomized, two-period, two-way crossover study in healthy male and
female subjects. The study results indicate that the product is
safe, and that the 90% confidence intervals of the three relevant
parameters Cmax, AUC(0-t) and AUC(0-infinity) are well within the
80 – 125 acceptance range for bioequivalency.
In June, 2013 the FDA assigned a PDUFA action date of February
3, 2014 for the review of the NDA for marketing approval.
Subsequent to the end of the year, in February, 2014 we received
a Complete Response Letter ("CRL") from the FDA. A CRL is issued by
the FDA's Center for Drug Evaluation and Research to inform
companies that certain questions and deficiencies remain that
preclude the approval of the application in its present form. The
questions raised by the FDA in the CRL regarding the NDA for our
anti-migraine VersaFilm™ product primarily relate to third party
Chemistry, Manufacturing and Controls ("CMC") and to the packaging
and labeling of the product. No questions or deficiencies were
raised relating to the product's safety and the FDA's CRL does not
require additional clinical studies. We believe that the majority
of issues raised by the FDA were addressed in an amendment
submitted by us to the FDA in January, 2014 that has yet to be
reviewed.
On March 3, 2014 we announced that we submitted a response to
the CRL which, we believe, addresses all the issues raised in the
CRL.
Opioid dependence Film
In accordance with a co-development and commercialization
agreement with Par, we developed an oral controlled-release film
product based on our proprietary VersaFilm™ technology. The product
is a generic formulation of buprenorphine and naloxone Sublingual
Film, indicated for maintenance treatment of opioid dependence. The
reference listed drug is Suboxone® Sublingual Film. A bioequivalent
film formulation was developed, scaled-up, and pivotal batches
manufactured and tested during a subsequent pivotal clinical study.
An ANDA was filed with the FDA by Par in July 2013.
In August, 2013 we learned that, in response to filing of the
ANDA, we were named as a codefendant in a lawsuit pursuant to
Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals
and Monosol RX in the U.S. District Court for the District of
Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and
8,017,150, each of which relate to Suboxone®. We believe the ANDA
product does not infringe those or any other patents, and will
vigorously defend ourselves in this matter. In accordance with the
terms of the co-development and commercialization agreement, Par is
financially responsible for the costs of this defense. Since
Paragraph IV litigation is a regular part of the ANDA process, we
do not expect any unanticipated impact on our already planned
development schedule.
Two new (undisclosed) projects
Subsequent to the end of the year, in January, 2014 we announced
the signing of another development and commercialization agreement
with Par Pharmaceutical, Inc. for two new products.
Under the terms of the agreement, Par has obtained certain
exclusive rights to market and sell our products in the USA. In
exchange we will receive upfront and milestone payments, together
with a share of the profits upon commercialization. In accordance
with confidentiality clauses contained in the agreement, the
specifics of the product descriptions, platform technologies and
financial terms remain confidential.
Corporate
Leadership succession
In April, 2013 we announced that Rajiv Khosla, RPh, PhD, MBA
would assume the role of President and Chief Executive Officer,
succeeding Horst G. Zerbe, PhD, with effect from January 1, 2014.
Dr. Zerbe will remain as Chairman of the Board of Directors and
continue to provide expertise in research and development, and
manufacturing.
Dr. Khosla held the positions of Chief Operating Officer and
Chief Scientific Officer throughout the transitional period of 2013
and was a member of the our Board of Directors for the previous two
years. Dr. Khosla has remarkable experience and credentials
including, among other senior positions, five years as Vice
President of Business Development at Biovail Corporation, a
Canadian pharmaceutical company operating internationally. Whilst
there, he successfully led the transaction process for more than 75
deal opportunities in a variety of therapeutic areas.
Dr. Khosla holds a Ph.D. in pharmaceutical science, with a
thesis on Oral Drug Delivery Technology; an Executive MBA from the
Henley Business School in England, a Bachelor of Pharmacy (Honours)
from the University of Nottingham, England and is a registered
pharmacist in the UK.
Dr. Khosla's biography can be found on our website at
http://www.intelgenx.com/aboutus/mngmt.html.
$3.5 Million Public Offering
In December, 2013 we announced the closing of a registered
public offering raising gross proceeds of approximately $3.5
million.
Earlier in the same month we entered into securities purchase
agreements with certain accredited investors for the issuance and
sale of an aggregate of 7,920,346 shares of its common stock at
$0.4419 per share. Additionally, investors received warrants to
purchase up to 7,920,346 shares of common stock at an exercise
price of $0.5646 per share for a term of five years.
Net proceeds, after deducting the placement agent's fee and
other estimated offering expenses payable by us were approximately
$3.0 million. We intend to use the net proceeds from the offering
for capital investments in VersaFilm™ manufacturing equipment,
leasehold improvements on a new facility, working capital and other
general corporate purposes.
H.C. Wainwright & Co., LLC acted as the exclusive placement
agent for the transaction.
Financial Results:
Cash on hand at December 31, 2013 increased to $5.0 million
compared with the cash balance of $2.1 million as at December 31,
2012. The increase in cash on hand relates to net cash provided by
financing activities of $4.5 million (2012 - $0.4 million), partly
offset by net cash used in operating activities of $1.1 million
(2012 - $1.6 million), net cash used in investing activities of
$0.3 million (2012 - $0.3 million), and an unrealized foreign
exchange loss of $0.1 million (2012 - unrealized foreign exchange
gain of $0.1 million). The net cash provided by financing
activities consists of approximately $3.0 million from a registered
public offering that we completed in December 2013, together with
approximately $1.5 million in proceeds received from the exercise
of warrants and stock options.
We intend to use the net proceeds from the registered public
offering for capital investments in VersaFilm™ manufacturing
equipment, new facility leasehold improvements, working capital and
other general corporate purposes.
Accounts receivable totaled $0.1 million as at December 31, 2013
compared with $1.3 million at December 31, 2012. The accounts
receivable balance at December 31, 2012 included an amount of $1.0
million related to the launch of Forfivo XL®™ that was invoiced to
our commercialization partner for Forfivo XL®, Edgemont
Pharmaceuticals, in the fourth quarter of 2012. Payment against the
invoice was received in February 2013.
Revenue for the year ended December 31, 2013 decreased to $0.9
million from $1.2 million in the previous year. In fiscal 2013, we
recorded approximately $0.5 million of revenue related to
commercial sales of Forfivo XL®, compared with a milestone of $1.0
million that was recorded as revenue in 2012 related to the launch
of Forfivo XL®.
Total expenses decreased from $3.5 million in fiscal 2012 to
$2.6 million in 2013, representing a reduction of $0.9 million, or
25%. The decrease is primarily attributable to a reduction in
R&D expenses that we incurred in 2012 for a) the development of
our buprenorphine and naloxone Sublingual Film of approximately
$0.7 million, b) the technical transfer of activities in
preparation for manufacturing of Forfivo XL® to our Contract
Manufacturing Organization, Pillar5 Pharma, of approximately $0.3
million (of which, approximately $0.1 million were credited to us
in fiscal 2013), and a Product Fee that we paid to the FDA for
Forfivo XL® of approximately $0.1 million, partly offset by an
increase in SG&A expenses attributable to the addition of Dr.
Rajiv Khosla to our management team.
The net loss decreased from $2.3 million in fiscal 2012 to a
loss of $1.6 million in 2013, and the loss per share decreased from
$0.04 per share in 2012 to $0.03 per share in 2013.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly
disintegrating delivery systems. IntelGenx uses its unique multiple
layer delivery system to provide zero-order release of active drugs
in the gastrointestinal tract. IntelGenx has also developed novel
delivery technologies for the rapid delivery of pharmaceutically
active substances in the oral cavity based on its experience with
rapidly disintegrating films. IntelGenx' development pipeline
includes products for the treatment of indications such as severe
depression, hypertension, erectile dysfunction, migraine, insomnia,
CNS indications, idiopathic pulmonary fibrosis, oncology and pain,
as well as animal health products. More information is available
about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about
IntelGenx' operating results and business prospects that involve
substantial risks and uncertainties. Statements that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended. These
statements include, but are not limited to, statements about
IntelGenx' plans, objectives, expectations, strategies, intentions
or other characterizations of future events or circumstances and
are generally identified by the words "may," "expects,"
"anticipates," "intends," "plans," "believes," "seeks,"
"estimates," "could," "would," and similar expressions. All forward
looking statements are expressly qualified in their entirety by
this cautionary statement. Because these forward-looking statements
are subject to a number of risks and uncertainties, IntelGenx'
actual results could differ materially from those expressed or
implied by these forward looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to, those discussed under the heading "Risk Factors" in
IntelGenx' annual report on Form 10-K for the fiscal year ended
December 31, 2013, filed with the United States Securities and
Exchange Commission and available at www.sec.gov, and also filed
with Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTCQX has neither approved
nor disapproved the contents of this press release.
CONTACT: Paul A. Simmons
Chief Financial Officer
IntelGenx Technologies Corp.
T: +1 514-331-7440
F: +1 514-331-0436
www.intelgenx.com
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