SEATTLE, Aug. 10, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER), a biopharmaceutical company committed
to discovering, developing and commercializing both 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 second quarter of
2015, which include:
- Revenues of $3.2 million,
$3.1 million of which resulted from
net product sales of Omidria® (phenylephrine and
ketorolac injection) 1% / 0.3% following its broad commercial U.S.
launch in mid-April
- Net loss of $16.7 million, or
$0.44 per share, which included
$2.7 million ($0.07 per share) of non-cash expenses for the
three months ended June 30, 2015
- Omidria reimbursement has already been established from all
Medicare Administrative Contractors across all states in the U.S.
and Puerto Rico and from nearly
all of the nation's top 30 commercial payers and others,
representing approximately 135 million insured lives
- Establishing Omidria financial assistance program for patients
covered by government insurers and a copay program for those
commercially insured – both programs are designed to expand access
to Omidria to all U.S. cataract surgery patients
- European Commission (EC) approved Omidria for use during
cataract surgery and lens replacement procedures throughout the
European Union (EU) as well as in Iceland, Lichtenstein, and Norway.
- Based on results seen in patients participating in the Phase 2
trial, investigator-requested extended access to OMS721 is now
available for compassionate use to European patients with TMAs
including atypical hemolytic uremic syndrome (aHUS)
- Entered into exclusive out-licensing agreement for
commercialization of OMS103 in the U.S.
"Building on the momentum of our successful controlled Omidria
launch, we made the product widely available in mid-April to
ophthalmic surgeons and their practices in the U.S. In addition to
driving breadth of expansion in our customer base across ambulatory
surgery centers and hospital outpatient departments including those
at 340B-eligible hospitals and academic institutions, we have
focused on securing coverage and reimbursement for Omidria patients
broadly across both government payers like Medicare and commercial
payers," said Gregory A. Demopulos,
M.D., chairman and chief executive officer of Omeros. "Our efforts
have been successful and, further supported by our patient
assistance and commercial copay programs, we expect to make Omidria
accessible by all patients across all insurer types, removing any
remaining financial impediment to use of Omidria for all who
qualify. We expect that success in the U.S. will help us in
Europe where the drug was recently
approved for commercialization, and we are pursuing our strategy of
entering into one or more marketing and distribution partnerships.
Through our OMS103 commercialization agreement with Fagron, sales
should begin this year, adding to the revenue stream generated by
Omidria. OMS721, in a Phase 2 clinical program for aHUS and other
TMAs, now has both orphan and Fast Track designations from FDA, is
available for compassionate use in Europe, and additional clinical trial data are
expected soon."
Second Quarter and Recent Highlights and Developments
- Omeros initiated the broad U.S. launch of Omidria in
April 2015, selling to wholesalers,
which in turn sell to ambulatory surgery center (ASC) and hospital
customers. This followed a successful controlled launch of Omidria
in February 2015, during which the
company sold Omidria directly to a small number of ASCs in the
U.S.
- Omeros entered into a Pharmaceutical Pricing Agreement with the
Secretary of Health and Human Services, which enables certain
entities that qualify for government pricing under the Public
Health Services Act to receive discounts on their qualified
purchases of Omidria, and a Federal Supply Schedule agreement under
which certain U.S. government purchasers receive a discount on
eligible purchases of Omidria. The company expects that these
agreements will further advance adoption of Omidria with those
entities and government purchasers.
- Omeros has established reimbursement for Omidria from all
Medicare Administrative Contractors and has secured coverage from
nearly all of the top 30 commercial insurers, including Aetna,
Cigna, Humana, Tri-Care, Wellpoint-Anthem and UnitedHealth Group.
Of the approximately 155 million lives represented by those top 30
insurers, coverage for Omidria has been secured to date for
approximately 135 million. Additional insurers, including AARP,
USAA and many of the Blue Cross/Blue Shield organizations, have
also been confirmed.
- To make Omidria accessible by all patients, Omeros is
establishing both a patient assistance program to support
government-insured patients who meet certain financial criteria as
well a commercial copay program whereby Omeros will financially
assist patients whose commercial coverage inadequately reimburses
for Omidria.
- The EC approved Omidria for use in cataract surgery and lens
replacement procedures to maintain mydriasis (pupil dilation),
prevent miosis (pupil constriction), and to reduce postoperative
eye pain. This approval allows for the marketing of Omidria in all
EU member states plus Iceland,
Lichtenstein, and Norway.
Decisions about price and reimbursement for Omidria are made on a
country-by-country basis and will be required before marketing may
occur in a particular country. Omeros' strategy remains to enter
into one or more partnerships for the marketing and distribution of
Omidria in the EU member states and other European countries.
- Omeros' OMS721, the company's lead human monoclonal antibody
targeting mannan-binding lectin-associated serine protease-2
(MASP-2), received Fast Track Designation from the FDA for the
treatment of patients with atypical hemolytic uremic syndrome
(aHUS). Omeros is currently evaluating the drug in a Phase 2
clinical trial for the treatment of aHUS and other thrombotic
microangiopathies (TMAs). TMAs are a family of rare, debilitating
and life-threatening disorders characterized by excessive thrombi
(clots) in the microcirculation of the body's organs, most commonly
the kidney and brain. Based on results seen in patients
participating in the Phase 2 trial, Omeros has made OMS721
available for expanded access for compassionate use.
- Omeros and affiliates of Fagron NV, Fagron Sterile Services and
JCB Laboratories (collectively Fagron), entered into an exclusive
license agreement for the U.S. commercialization of Omeros' OMS103,
developed by Omeros for use during arthroscopic surgery. Fagron is
obligated to meet performance diligence requirements including the
commencement of commercial supply of OMS103 in 2015.
- The company is discussing with FDA the re-initiation of the
OMS824 Phase 2 Huntington's and schizophrenia programs following
submission of the package of nonclinical materials requested by the
FDA. The company looks forward to re-activating enrollment in its
Phase 2 clinical programs as soon as possible.
Financial Results
For the quarter ended June 30, 2015, revenue was $3.2 million, including $3.1 million from Omidria sales and grant revenue
of $62,000. Grant revenue for the
quarter ended June 30, 2014 was
$45,000.
Total costs and expenses for the three months ended
June 30, 2015 were $19.2 million compared to $17.3 million for the same period in 2014. The
increase was primarily due to expenses related to sales and
marketing costs for the broad U.S. commercial launch of
Omidria.
For the three months ended June 30,
2015, Omeros reported a net loss of $16.7 million, or $0.44 per share, which included noncash expenses
of $2.7 million ($0.07 per share). This compares to a net loss of
$18.0 million, or $0.53 per share, for the same period in 2014,
which included noncash expenses of $2.2
million ($0.06 per share).
At June 30, 2015, Omeros had cash,
cash equivalents and short-term investments of $51.4 million.
Conference Call Details
Omeros' management will host a
conference call to discuss the financial results and to provide an
update on business activities. The event will be held today at
1:30 p.m. Pacific Time (PT);
4:30 p.m. Eastern Time (ET). 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 2186632. 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 2186632.
To access the live or 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
both 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 (IOL) replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. In the EU,
European Commission (EC) has approved Omidria for use in cataract
surgery and lens replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and to
reduce postoperative eye pain. Omeros has partnered its
arthroscopic product, OMS103, for commercialization with Fagron
Sterile Services and affiliated JCB Laboratories. Omeros has five
clinical-stage development programs focused on: complement-related
thrombotic microangiopathies; Huntington's disease, schizophrenia,
and cognitive impairment; and addictive and compulsive disorders.
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, product commercialization including
with respect to Omidria® and OMS103, risks associated
with Omeros' ability to partner and commercialize Omidria in
Europe, Omeros' unproven
preclinical and clinical development activities, regulatory
oversight, intellectual property claims, competitive developments,
litigation, and the risks, uncertainties and other factors
described under the heading "Risk Factors" in the company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 10,
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
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Product
sales
|
$ 3,125
|
|
$
-
|
|
$
3,363
|
|
$
-
|
Grant
revenue
|
62
|
|
45
|
|
212
|
|
145
|
Total
revenue
|
3,187
|
|
45
|
|
3,575
|
|
145
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
365
|
|
-
|
|
376
|
|
-
|
Research and
development
|
10,900
|
|
12,407
|
|
20,218
|
|
24,424
|
Selling, general and
administrative
|
7,889
|
|
4,855
|
|
16,878
|
|
8,622
|
Total costs and
expenses
|
19,154
|
|
17,262
|
|
37,472
|
|
33,046
|
Loss from
operations
|
(15,967)
|
|
(17,217)
|
|
(33,897)
|
|
(32,901)
|
Interest
expense
|
(937)
|
|
(939)
|
|
(1,894)
|
|
(1,611)
|
Investment income and
other income (expense), net
|
224
|
|
165
|
|
442
|
|
(121)
|
Net loss
|
$ (16,680)
|
|
$ (17,991)
|
|
$ (35,349)
|
|
$
(34,633)
|
Basic and diluted net
loss per share
|
$
(0.44)
|
|
$
(0.53)
|
|
$
(0.95)
|
|
$
(1.07)
|
Weighted-average
shares used to compute
|
|
|
|
|
|
|
|
basic and diluted net
loss per share
|
37,846,832
|
|
33,933,356
|
|
37,165,196
|
|
32,415,198
|
OMEROS
CORPORATION
|
CONSOLIDATED
BALANCE SHEET DATA
|
(In
thousands)
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
|
$ 51,446
|
|
$
6,886
|
Total
assets
|
|
58,637
|
|
11,090
|
Total current
liabilities
|
|
20,096
|
|
18,431
|
Notes
payable
|
|
30,771
|
|
32,709
|
Accumulated
deficit
|
|
(363,395)
|
|
(328,046)
|
Total shareholders'
equity (deficit)
|
|
7,932
|
|
(42,654)
|
|
|
|
|
|
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SOURCE Omeros Corporation