SEATTLE, March 16, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER), a biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market as well as orphan indications
targeting inflammation, coagulopathies and disorders of the central
nervous system, today announced recent highlights and developments
as well as financial results for the fourth quarter and year ended
December 31, 2014, which include:
- Net loss in 4Q 2014 of $20.7
million or $0.61 per share
and, for the full year of 2014, a net loss of $73.7 million or $2.22 per share
- Operating expenses in 4Q 2014 were $20.2
million including $4.2 million
of non-cash expenses and, for the full year of 2014, were
$70.5 million including non-cash
expenses of $11.7 million
- Center for Medicare and Medicaid Services (CMS) granted
FDA-approved Omidria™ (phenylephrine and ketorolac
injection) 1%/0.3% transitional pass-through reimbursement status
in October 2014, effective
January 1, 2015
- Closed equity financing in February
2015, receiving $79.1 million
in net proceeds
"2014 was a year of many important achievements for Omeros,
transitioning us from a solely R&D to a commercial company with
FDA's approval of Omidria," said Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Omeros. "Receipt of pass-through status from CMS, we expect, will
accelerate our commercial success. The controlled launch of Omidria
began in February and the feedback from those surgeons using
Omidria has been uniformly positive. The broad launch of Omidria is
planned for early April, which will coincide nicely with the
product's increased visibility at the annual meeting of the
American Society of Cataract and Refractive Surgery later that
month. Our pipeline programs also made substantial progress, most
notably resulting in positive preliminary data in the Phase 2
clinical trial evaluating OMS721, our proprietary MASP-2 antibody
currently in development for the treatment of TMAs."
Fourth Quarter and Recent Highlights
- CMS granted Omidria pass-through reimbursement status,
effective January 1, 2015.
Pass-through status allows for separate payment for new drugs and
other medical technologies that meet well-established criteria
specified by federal regulations governing Medicare spending.
Omeros expects pass-through to remain in effect until December 31, 2017, near which time CMS will
evaluate utilization of Omidria and will re-assess its
reimbursement status. CMS has set the reimbursement rate for
Omidria under Medicare Part B at the product's wholesale
acquisition cost (WAC) of $465 plus
six percent (6%) per single-use vial for the second and third
quarters of 2015 after which the rate will be based on average
selling price (ASP) plus six percent (6%). Based on Omeros'
discussions with CMS, the company expects this pass-through
reimbursement to be effective as of January
1, 2015.
- Continued preparations for the full-scale U.S. launch of
Omidria in early April 2015, which
was preceded in February by a controlled product launch targeting
all regions across the U.S. Activities included deploying
additional field sales representatives, bringing the total number
of representatives to 40, developing distribution and access
strategy, publishing product advertisements in trade journals and
building a presence at key ophthalmologic conferences and within
the ophthalmic surgery community.
- Announced that the company had completed dosing of the low-dose
cohort of patients in its Phase 2 clinical trial evaluating the
efficacy and safety of OMS721, the lead human monoclonal antibody
for the company's mannan-binding lectin-associated serine
protease-2 (MASP-2) program, in treating thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic
syndrome (aHUS). All patients in this study cohort received OMS721
and improvements were observed across TMA disease markers. Experts
in this disease field, including the study investigators, believe
that the patients' improvements were clinically meaningful and
directly related to treatment with OMS721. Based on the clinical
results, a European investigator also has requested that Omeros
provide extended access to OMS721 for compassionate use in patients
with TMAs. This request is subject to approval by the applicable
regulatory authority.
- Reported positive data in nonclinical studies of OMS721 or its
derivative (1) in an ex vivo pathophysiologic system of aHUS
for inhibition of thrombus formation and (2) in a well-established
animal model of stroke to reduce size of brain infarction and to
protect against neurological deficits.
- Continued evaluation of data from a single nonclinical rat
study in the company's OMS824 program. Omeros is finalizing the
package of nonclinical materials requested by the FDA to allow
re-initiation of the OMS824 programs, and the company looks forward
to re-activating enrollment in its Phase 2 clinical programs in the
near future.
- Closed a public equity offering in February 2015 by which the company received net
proceeds of approximately $79.1
million.
Financial Results
For the quarter ended December 31, 2014, Omeros reported a net loss of
$20.7 million or $0.61 per share, including non-cash expenses of
$4.2 million or $0.12 per share. This compares to a net loss of
$1.8 million or $0.05 per share, including non-cash expenses of
$2.6 million or $0.09 per share, for the same period in 2013. The
2013 period includes a $12.5 million
or $0.41 per share reduction of our
net loss related to receiving a nonrecurring payment upon
settlement of litigation. Excluding the litigation settlement, the
loss for the fourth quarter of 2013 would have been $14.3 million or $0.47 per share.
For the full year 2014, Omeros reported a net loss of
$73.7 million or $2.22 per share, including non-cash expenses of
$11.7 million or $0.35 per share. This compares to a net loss of
$39.8 million or $1.39 per share in 2013, including non-cash
expenses of $10.6 million or
$0.37 per share. Excluding the
litigation settlement, the 2013 net loss would have been
$52.3 million or $1.83 per share.
Operating expenses for the three months ended December 31, 2014 were $20.2 million compared to $14.1 million for the same period in 2013, an
increase of $6.1 million. The
increase was primarily related to preparing for the U.S. commercial
launch of Omidria, to non-cash expenses related to stock-based
compensation, to increased employee costs and to the U.S. pediatric
clinical trial evaluating Omidria, which began during 2014. These
increased expenses were partially offset by lower clinical research
and development expenses due to the timing of clinical trials
evaluating OMS824.
Operating expenses for the year ended December 31, 2014 were $70.5 million, an increase of $18.4 million compared to $52.1 million in 2013. The 2014 increase related
primarily to preparing for the U.S. commercial launch of Omidria,
to clinical trials evaluating OMS824 and OMS721, to Phase 3
clinical trials for Omidria, and to increased employee costs and
non-cash expenses related to stock-based compensation. These
increased expenses were partially offset by lower preclinical
activity on the PDE7 program.
Revenue for the quarter ended December
31, 2014 was $180,000 compared
to $169,000 for the same period in
2013. For the year ended December 31,
2014, revenue was $539,000
compared to $1.6 million in 2013. The
decrease for the full year 2014 was due to lower revenue recognized
from the GPCR program funding agreements with Vulcan and LSDF, and
the company will not recognize any additional revenue under these
agreements in future periods.
At December 31, 2014, the company
had cash and cash equivalents and short-term investments of
$6.9 million. In February 2015 the company sold 3,444,831 shares
of common stock at a public offering price of $20.03 per share and sold pre-funded warrants to
purchase up to 749,250 shares of common stock at a public offering
price of $20.02 per warrant share,
each warrant share having an exercise price of $0.01. After deducting underwriting discounts and
other offering expenses, Omeros received net proceeds of
approximately $79.1 million.
2015 Guidance
For 2015, the company anticipates that
operating expenses will be in the $110
million to $120 million range with non-cash expenses of
approximately $15 million. This
guidance is largely based on the continued preparations for the
full-scale U.S. launch of Omidria as well as the continued
development of the company's product pipeline.
Conference Call Details
To access the live conference
call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The
participant passcode is 1480892. Please dial in approximately 10
minutes prior to the start of the call. A telephone replay will be
available for one week following the call and may be accessed by
dialing (855) 859-2056 from the United
States and Canada or (404)
537-3406 internationally. The replay passcode is 1480892.
To access the live and subsequently archived webcast of the
conference call, go to the Company's website at
www.omeros.com and go to "Events" under the Investors section
of the website. Please connect to the website at least 15 minutes
prior to the call to allow for any software download that may be
necessary.
About Omeros Corporation
Omeros is a biopharmaceutical
company committed to discovering, developing and commercializing
small-molecule and protein therapeutics for large-market as well as
orphan indications targeting inflammation, coagulopathies and
disorders of the central nervous system. Derived from its
proprietary PharmacoSurgery® platform, the company's
first drug product, Omidria™ (phenylephrine and
ketorolac injection) 1%/0.3%, has been approved by the FDA for use
during cataract surgery or intraocular lens replacement (ILR) to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. Omeros is
completing preparations for a planned full-scale U.S. product
launch in early April 2015. Omidria
is currently under review for marketing approval by the European
Medicines Agency. Omeros has six clinical-stage development
programs focused on: complement-related thrombotic
microangiopathies; Huntington's disease, schizophrenia, and
cognitive impairment; addictive and compulsive disorders; and
preventing problems associated with surgical procedures. In
addition, Omeros has a proprietary GPCR platform, which is making
available an unprecedented number of new GPCR drug targets and
corresponding compounds to the pharmaceutical industry for drug
development.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934, which are subject to the "safe harbor" created by
those sections for such statements. All statements other than
statements of historical fact are forward-looking statements, which
are often indicated by terms such as "anticipate," "believe,"
"could," "estimate," "expect," "goal," "intend," "look forward to,"
"may," "plan," "potential," "predict," "project," "should," "will,"
"would" and similar expressions. Forward-looking statements are
based on management's beliefs and assumptions and on information
available to management only as of the date of this press release.
Omeros' actual results could differ materially from those
anticipated in these forward-looking statements for many reasons,
including, without limitation, risks associated with Omeros'
ability to begin broad U.S. commercial sales of Omidria™
(OMS302) in early April 2015, Omeros'
ability to obtain regulatory approval for its Marketing
Authorization Application in the EU for the commercialization of
Omidria, Omeros' unproven preclinical and clinical development
activities, regulatory oversight, product commercialization,
intellectual property claims, competitive developments, litigation,
and the risks, uncertainties and other factors described under the
heading "Risk Factors" in the company's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 16, 2015. Given these risks, uncertainties
and other factors, you should not place undue reliance on these
forward-looking statements, and the company assumes no obligation
to update these forward-looking statements, even if new information
becomes available in the future.
OMEROS
CORPORATION
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(In thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
December
31,
|
|
December
31,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
(unaudited)
|
|
|
|
|
Revenue
|
$
180
|
|
$
169
|
|
$
539
|
|
$
1,600
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
11,750
|
|
10,186
|
|
47,946
|
|
36,297
|
Selling, general and
administrative
|
8,405
|
|
3,885
|
|
22,601
|
|
15,819
|
Total operating
expenses
|
20,155
|
|
14,071
|
|
70,547
|
|
52,116
|
Loss from
operations
|
(19,975)
|
|
(13,902)
|
|
(70,008)
|
|
(50,516)
|
Litigation
settlement
|
-
|
|
12,500
|
|
-
|
|
12,500
|
Investment
income
|
2
|
|
2
|
|
12
|
|
12
|
Interest
expense
|
(915)
|
|
(598)
|
|
(3,470)
|
|
(2,366)
|
Other income
(expense), net
|
175
|
|
153
|
|
(207)
|
|
574
|
Net loss
|
$
(20,713)
|
|
$
(1,845)
|
|
$
(73,673)
|
|
$
(39,796)
|
Basic and diluted net
loss per share
|
$
(0.61)
|
|
$
(0.05)
|
|
$
(2.22)
|
|
$
(1.39)
|
Weighted-average
shares used to compute basic
and diluted net loss per share
|
34,101,139
|
|
30,289,041
|
|
33,234,294
|
|
28,560,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OMEROS
CORPORATION
|
CONSOLIDATED
BALANCE SHEET DATA
|
(In
thousands)
|
|
|
December
31,
|
|
December
31,
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents and short-term investments
|
|
$
6,886
|
|
$
14,101
|
Total
assets
|
|
11,090
|
|
16,535
|
Total notes
payable
|
|
32,709
|
|
20,498
|
Total current
liabilities
|
|
18,431
|
|
11,873
|
Accumulated
deficit
|
|
(328,046)
|
|
(254,373)
|
Total shareholders'
equity (deficit)
|
|
(42,654)
|
|
(18,384)
|
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SOURCE Omeros Corporation