SEATTLE, Wash., Nov. 7, 2013 /PRNewswire/ --
Omeros Corporation (NASDAQ: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the third quarter of 2013.
"Throughout the third quarter of 2013, we continued to make significant strides in development across our pipeline," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "For OMS302, the marketing applications were accepted for review by both the FDA and EMA, and the market launch is planned for the second half of 2014. Our OMS824 program for the treatment of cognitive disorders was granted orphan drug designation by the FDA, generated positive Phase 1 clinical trial results, began enrollment in a Phase 2 trial in patients with schizophrenia and is now initiating a Phase 2 trial in Huntington's disease. OMS721, our MASP-2 inhibitor, entered a Phase 1 clinical trial from which we reported positive data today, and a Phase 2 trial to evaluate the molecule's efficacy and safety in patients with thrombotic microangiopathies is planned for early 2014. Preclinically, our GPCR platform continued to identify functionally active compounds against an unprecedented number of orphan receptors, and our addiction and high-risk bleeding programs advanced toward the clinic. Following the close of the quarter, we added over $17 million to our balance sheet, positioning Omeros to execute on a series of value-driving milestones during the remainder of 2013 and well into 2014."
Third Quarter and Recent Highlights
Financial ResultsTotal operating expenses for the quarter ended September 30, 2013 were $13.6 million and included non-cash expenses of $3.2 million related to rent expense and stock-based compensation. For the same period in 2012, total operating expenses were $14.5 million, which included non-cash rent and stock-based compensation expenses of $576,000.
The decrease in total operating expenses for the quarter ended September 30, 2013 compared to the prior year quarter is primarily due to a litigation settlement expense of $3.95 million recorded in the same period in 2012, which was reimbursed by CCIC in the fourth quarter of 2012. For the quarter ended September 30, 2013, total (i.e., cash and non-cash) operating expenses, excluding the litigation expense, increased by $3.1 million compared to the same period in 2012. The increase was primarily due to the non-cash rent and stock-based compensation expenses of $3.2 million in 3Q 2013 compared to $576,000 in 3Q 2012. The remaining increases were related to conducting the company's Phase 1 clinical program evaluating OMS824, advancing our MASP-2 program, preparing the New Drug Application (NDA) and Marketing Authorization Application (MAA) for OMS302, planning for the commercial launch of OMS302 in the second half of 2014, and non-recurring legal expenses incurred in connection with the CCIC matter. These higher costs were partially offset by lower overall clinical trial expenses related to the completion of the company's OMS302 Phase 3 clinical program in January 2013 and the completion of the company's first OMS103HP Phase 3 clinical trial in arthroscopic partial meniscectomy patients in December 2012.
Total revenue for the quarter ended September 30, 2013 was $196,000 compared to $1.4 million for the same period in 2012. This decrease was primarily due to lower revenue recognized from the company's GPCR platform development funding agreement with Vulcan Inc. and its affiliate. While research continues under the company's GPCR program, no additional deferred revenue under the Vulcan agreement remains to be recognized after the first quarter of 2013.
For the quarter ended September 30, 2013, Omeros reported a net loss of $13.9 million, or $0.46 per share, inclusive of the above-referenced $3.2 million of non-cash charges equaling $0.11 per share, compared to a net loss of $13.3 million, or $0.51 per share, inclusive of the above-referenced $576,000 of non-cash charges equaling $0.02 per share, for the same period in 2012.
At September 30, 2013, Omeros had cash, cash equivalents and short-term investments of $9.0 million. On October 24, 2013, subsequent to the end of the quarter, Omeros received a payment of $12.5 million from CCIC pursuant to the terms of the settlement agreement. Omeros also received $4.9 million in net proceeds from the sale of 373,700 shares of its common stock, sold at an average price of $13.29 per share, pursuant to the company's at-the-market equity facility in October 2013.
About Omeros CorporationOmeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for the second half of 2014. Omeros' five other clinical programs are focused on schizophrenia, Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also 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 StatementsThis 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," "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, risks associated with Omeros' unproven preclinical and clinical development activities, regulatory oversight, commercialization of its products, intellectual property claims 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 9, 2013. 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 CORPORATIONCONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except share and per share data)Three Months EndedNine Months EndedSeptember 30,September 30,2013201220132012(unaudited)(unaudited)Revenue
4,439Operating expenses:Research and development
22,568Selling, general and administrative
3,953Total operating expenses
33,791Loss from operations
(1,360)Other income, (expense) net
(30,710)Basic and diluted net loss per common share
(1.30)Weighted-average shares used to compute basic and diluted net loss per common share
23,578,724OMEROS CORPORATIONCONSOLIDATED BALANCE SHEET DATA(In thousands)September 30,December 31,20132012Cash and cash equivalents and short-term investments
26,575Total notes payable
20,103Total current liabilities
(214,577)Total shareholders' equity (deficit)
|SOURCE Omeros Corporation|
Copyright©2012 PR Newswire.
All rights reserved