Omeros Corporation Reports First Quarter 2017 Financial Results
-- Conference Call Today at
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 $0.34per share, including $4.4 million( $0.10per 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
FDAto 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 milliondebt 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
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
March 2017, Omerosreported 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
FDAregarding a Phase 3 program for OMS721 in IgA nephropathy, the company submitted an application for breakthrough therapy designation. Omerosplans to pursue breakthrough therapy or fast track designation for OMS721 in HSCT-TMA. Omerosalso is pursuing accelerated approval for OMS721 in aHUS. The FDAhas 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 Transplantationand 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
European Society for Blood and Marrow Transplantation.
In April, Phase 2 clinical data in aHUS were presented at the
International Societyof 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 millionin 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.
For the quarter ended
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
Interest expense for the three months ended
For the three months ended
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
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.
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
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
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended|
|Product sales, net||$||12,257||$||7,246|
|Costs and expenses:|
|Cost of product sales||271||327|
|Research and development||12,240||15,434|
|Selling, general and administrative||12,471||11,110|
|Total costs and expenses||24,982||26,871|
|Loss from operations||(12,725||)||(19,452||)|
|Other income (expense), net||299||288|
|Basic and diluted net loss per share||$||(0.34||)||$||(0.54||)|
Weighted-average shares used to compute
basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||33,653||$||45,331|
|Restricted cash and investments||5,835||5,835|
|Total current liabilities||16,973||16,071|
|Notes payable and lease financing obligations||80,731||79,710|
|Total shareholders’ deficit||(48,113||)||(37,447||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations