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Omeros Corporation Reports Second Quarter 2016 Financial ResultsOmeros 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 2016, which include:
"OMIDRIA generated solid sales growth in the second quarter," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "That growth was broad based; not only did we add a significant number of new accounts, but existing customers continued to increase their level of utilization - it clearly appears that we have turned the corner with respect to the recognition of the clinical benefits of OMIDRIA. The revenues from OMIDRIA are increasingly defraying the costs of our development pipeline, which continues to deliver on that investment. OMS721, our MASP-2 inhibitor program, is in a Phase 3 clinical program in aHUS and in two Phase 2 programs, one for patients with microangiopathies and the other for those with complement-related renal disease. Our PDE10 inhibitor is in a Phase 2 program in Huntington's disease, we expect OMS405 - our PPAR-gamma agonist program for addiction - to yield additional data this year, our PDE7 inhibitor program for addiction is slated to enter the clinic next year and our MASP-3 and GPCR programs are making good progress. We look forward to building on the commercial and clinical momentum generated in the first half of 2016 and expect to continue that momentum through the remainder of the year." Second Quarter and Recent Highlights and Developments
Financial Results For the quarter ended June 30, 2016, total revenues were $10.0 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $3.1 million and grant revenue of $62,000 for the same period in 2015. On a sequential quarter basis, OMIDRIA revenue grew $2.8 million or 38% from 1Q to 2Q 2016. The quarter-over-quarter increase in OMIDRIA revenue was due to continued acceptance of and increased demand for OMIDRIA in the ophthalmic surgery community. Total costs and expenses for the three months ended June 30, 2016 were $20.9 million ($3.2 million of which were non-cash expenses) compared to $19.2 million ($2.7 million of noncash expenses) for the same period in 2015. The increase in the current year quarter was primarily due to increased legal costs associated with the Par lawsuit and increased sales and marketing costs, partially offset by a decrease in research and development costs. For the three months ended June 30, 2016, Omeros reported a net loss of $12.6 million, or $0.32 per share, which included noncash expenses of $3.2 million ($0.08 per share). This compares to the prior year quarter where 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). For the six months ended June 30, 2016, total revenues were $17.4 million, consisting of $17.3 million of sales of OMIDRIA and $173,000 of grant revenue. This compares to OMIDRIA revenues of $3.4 million and grant revenue of $212,000 for the same period in 2015. This increase in sales of OMIDRIA is due to the continued acceptance of and increased demand for OMIDRIA in the ophthalmic surgery community. Total costs and expenses for the six months ended June 30, 2016 were $47.8 million compared to $37.5 million for the same period in 2015. The increase in the current year compared to the prior year was primarily due to increases in OMS721 research and development costs, legal costs associated with the Par lawsuit, sales and marketing costs and stock-based compensation expense. For the six months ended June 30, 2016, Omeros reported a net loss of $33.2 million, or $0.86 per share, which included noncash expenses of $7.9 million ($0.20 per share). This compares to a net loss of $35.3 million, or $0.95 per share for the six months ended June 30, 2015, which included noncash expenses of $5.5 million ($0.15 per share). At June 30, 2016, the company had cash, cash equivalents and short-term investments of $21.2 million. In addition, the company had $10.7 million of restricted cash on hand to satisfy covenants under its loan agreement with Oxford Finance and East West Bank and its lease for the Omeros Building. 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; 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 60834344. 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 60834344. 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. To access the live call, 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%, was broadly launched in the U.S. in April 2015 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 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-related thrombotic microangiopathies; complement-mediated glomerulopathies; Huntington's disease and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic 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, 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 including with respect to OMIDRIA®, Omeros' ability to partner and commercialize OMIDRIA in the Middle East and Europe, Omeros' unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation including pending patent litigation related to an application seeking approval from the FDA to market a generic version of OMIDRIA, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. 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.
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