-- Conference Call Today at 4:30 p.m. ET
--
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
first quarter of 2017, which include:
- 1Q 2017 total and OMIDRIA® revenues
were $12.3 million. Revenues from OMIDRIA sales rose 69.2% from the
prior year’s first quarter.
- OMIDRIA units shipped by wholesalers
(“sell-through”) increased 14.2% over 4Q 2016 and 107.2% over 1Q
2016.
- The difference in sell-through and
sales revenues in 1Q 2017 was primarily due to transient reductions
in wholesaler inventories, which was replenished by wholesaler
purchases during the first week in April.
- Net loss in 1Q 2017 was $15.1 million,
or $0.34 per share, including $4.4 million ($0.10 per share) of
non-cash expenses.
- Positive data were announced from Phase
2 clinical trials of OMS721 in both renal disorders and
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA).
- Successful meeting was held with FDA to
discuss OMS721 Phase 3 program for immunoglobin A (IgA)
nephropathy; company submitted an application for breakthrough
therapy designation.
- Ability to access, at Omeros’ election,
$25.0 million debt tranche from affiliates of CRG LP (CRG).
“The first quarter of 2017 was largely a story of progress for
OMIDRIA and our MASP-2 inhibitor OMS721,” said Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros.
“Utilization of OMIDRIA continued its double-digit growth as
ophthalmic surgeons increasingly recognize the drug’s clinical
benefits, driving expansion across and within surgical facilities.
We began the quarter with one OMS721 Phase 3 program in aHUS and
are now poised to initiate two additional Phase 3 programs in IgA
nephropathy and stem cell transplant-associated thrombotic
microangiopathies. In addition, one part of our addiction franchise
is in Phase 2, the other is expected to enter the clinic early next
year and our GPCR program continues to break new ground.
Collectively, these achievements and the related milestones that
follow we expect bode well for the remainder of 2017 and
beyond.”
First Quarter and Recent Highlights and Developments
- Highlights and developments regarding
OMS721, Omeros’ lead human monoclonal antibody in its
mannan-binding lectin-associated serine protease-2 (MASP-2)
programs for the treatment of thrombotic microangiopathies (TMAs),
including aHUS and HSCT-TMA, and for the treatment of
complement-related renal diseases, including IgA nephropathy,
include:
- In March 2017, Omeros reported positive
data from its Phase 2 clinical trial evaluating OMS721 in the
treatment of HSCT-TMA. Consistent with previously reported results,
statistically significant and clinically meaningful improvements in
TMA disease activity were observed over the course of treatment,
specifically in mean platelet count, mean lactate dehydrogenase and
mean haptoglobin. Mean creatinine also improved but did not reach
statistical significance.
- The company announced positive data
from its Phase 2 clinical trial of OMS721 for the treatment of
serious kidney disorders, including IgA nephropathy, in March 2017.
Treatment effects across all IgA nephropathy patients were
consistent, the magnitude of which are associated with improved
renal survival. The trial assesses the effect of OMS721 on urine
protein measures that are predictive of kidney failure, namely
urine albumin-to-creatinine ratio (uACR) and total 24-hour urine
protein excretion, and on the ability to reduce steroid dosing. As
reported for the three patients who completed treatment, mean
improvement in uACR values was 76% and mean decrease in 24-hour
urine protein levels was 66%. Concurrently, daily steroid doses for
all patients were substantially reduced or completely
eliminated.
- Following discussion with the FDA
regarding a Phase 3 program for OMS721 in IgA nephropathy, the
company submitted an application for breakthrough therapy
designation. Omeros plans to pursue breakthrough therapy or fast
track designation for OMS721 in HSCT-TMA. Omeros also is pursuing
accelerated approval for OMS721 in aHUS. The FDA has already
granted fast track designation for OMS721 in patients with aHUS and
orphan designation for OMS721 in patients with complement-mediated
TMAs, including aHUS and HSCT-TMA.
- In February, Phase 2 clinical data in
HSCT-TMA were presented at the 2017 Tandem Meeting of the American
Society for Blood and Marrow Transplantation and the Center for
International Blood and Marrow Transplant Research.
- In March, a case report describing
resolution of HSCT-TMA in a 15-year old patient was presented at
the 43rd Annual Meeting of the European Society for Blood and
Marrow Transplantation.
- In April, Phase 2 clinical data in aHUS
were presented at the International Society of Nephrology’s World
Congress of Nephrology.
- IND-enabling toxicology studies were
initiated for OMS527, the company’s phosphodiesterase 7, or PDE7,
inhibitor for the treatment of addiction and compulsive
disorders.
- CRG has agreed to provide the next
tranche of $25.0 million in debt financing under the company’s
existing credit facility, which can be drawn at Omeros’ election.
The election to borrow must be made by the end of August.
Financial Results
For the quarter ended March 31, 2017, total revenues were $12.3
million, all relating to sales of OMIDRIA. This compares to OMIDRIA
revenues of $7.2 million and grant revenue of $173,000 for the same
period in 2016. Our 1Q 2017 OMIDRIA revenues decreased from those
in 4Q 2016 by $648,000. The decrease was primarily due to the
timing of wholesaler orders, resulting in transient reductions in
wholesaler inventories at March 31, 2017 compared to December 31,
2016, and, to a lesser extent, the first full quarter of operation
for the company’s OMIDRIA purchase volume discount programs. This
March 31, 2017 deficit in wholesaler inventories was replenished in
the first week of April when wholesalers purchased a net amount of
$2.1 million of OMIDRIA, returning inventories to traditional
levels and supporting ongoing demand.
OMIDRIA units sold by wholesalers to customers increased 14.2%
from 4Q 2016 to 1Q 2017 and 107.2% from 1Q 2016 to 1Q 2017.
Total costs and expenses for the three months ended March 31,
2017 were $25.0 million (including $4.4 million of non-cash
expenses) compared to $26.9 million (including $4.7 million of
non-cash expenses) for the same period in 2016. The decrease in the
first quarter was primarily due to decreased clinical research and
development costs associated with the timing of clinical trials and
manufacturing and reduced stock compensation. These decreases were
partially offset by increased legal costs associated with the Par
lawsuit.
Interest expense for the three months ended March 31, 2017 was
$2.7 million as compared to $1.4 million in the prior year first
quarter. The increase is due to interest on incremental borrowings
Omeros made in 2Q and 4Q 2016.
For the three months ended March 31, 2017, Omeros reported a net
loss of $15.1 million, or $0.34 per share, which included non-cash
expenses of $4.4 million ($0.10 per share). This compares to the
prior year’s first quarter, when Omeros reported a net loss of
$20.5 million, or $0.54 per share, which included non-cash expenses
of $4.7 million ($0.12 per share).
Conference Call Details
Omeros’ management will host a conference call to discuss the
financial results and to provide an update on business activities.
The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m.
Eastern Time. 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 17386705.
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 17386705.
To access the live or subsequently archived webcast of the
conference call on the internet, go to the company’s website at
www.omeros.com and select “Events” under the Investors section of
the website. To access the live webcast, 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. Part of its proprietary
PharmacoSurgery® platform, the company’s first drug product,
OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, is the
first and only FDA-approved drug (1) 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 and (2) that contains an NSAID
for intraocular use. In the European Union, the European
Commission 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 clinical-stage
development programs focused on: complement-associated thrombotic
microangiopathies; complement-mediated glomerulonephropathies;
Huntington’s disease and cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a
proprietary G protein-coupled receptor (GPCR) platform, which is
making available an unprecedented number of new GPCR drug targets
and corresponding compounds to the pharmaceutical industry for drug
development, and a platform used to generate antibodies.
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 and variations thereof. 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 product
commercialization and commercial operations, financial
reimbursement coverage from governmental and third-party payers for
products and related treatments, 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 May 10, 2017. 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 UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS (In thousands, except share and per
share data) Three Months Ended March 31,
2017 2016 Revenues: Product sales, net $
12,257 $ 7,246 Grant revenue — 173 Total revenue
12,257 7,419 Costs and expenses: Cost of product
sales 271 327 Research and development 12,240 15,434 Selling,
general and administrative 12,471 11,110 Total costs
and expenses 24,982 26,871 Loss from operations
(12,725 ) (19,452 ) Interest expense (2,663 ) (1,375 ) Other income
(expense), net 299 288 Net loss $ (15,089 ) $ (20,539
) Basic and diluted net loss per share $ (0.34 ) $ (0.54 )
Weighted-average shares used to compute
basic and diluted net loss per share
43,828,572 38,317,084
OMEROS
CORPORATION UNAUDITED CONSOLIDATED BALANCE SHEET DATA
(In thousands) March 31, December 31,
2017 2016 Cash, cash equivalents and short-term
investments $ 33,653 $ 45,331 Working capital 34,381 44,191
Restricted cash and investments 5,835 5,835 Total assets 58,404
67,278 Total current liabilities 16,973 16,071 Notes payable and
lease financing obligations 80,731 79,710 Accumulated deficit
(484,976 ) (469,887 ) Total shareholders’ deficit (48,113 ) (37,447
)
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version on businesswire.com: http://www.businesswire.com/news/home/20170510006505/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360-668-3701jennifer@cwcomm.org
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