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Omeros Corporation Reports Second Quarter 2015 Financial Results -- Conference Call Today at 4:30 p.m. ET -- SEATTLE, WA

Key Takeaway: Omeros Corporation Reports Second Quarter 2015 Financial Results -- Conference Call Today at 4:30 p.m. ET -- SEATTLE, WA -- August 10, 2015 -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-mole

Full Press Release Details

Omeros Corporation Reports Second Quarter 2015 Financial Results
-- Conference Call Today at 4:30 p.m. ET --
SEATTLE, WA -- August 10, 2015 -- 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:
"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
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.
Investor and Media Relations
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
CONSOLIDATED BALANCE SHEET DATA
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 )
Last updated: Aug 10, 2015