Full Press Release Details
Omeros Corporation Reports Third Quarter 2015 Financial Results
-- Conference Call Today at 4:30 p.m. ET --
SEATTLE, WA -- November 9, 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 third quarter of 2015, which include:
"The clinical acceptance of Omidria is strong and, throughout the third quarter, we continue to expand broadly reimbursement for Omidria across both government and commercial payers," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With the fourth-quarter introduction of OMIDRIAssure , we have now expanded access to all cataract surgery patients and have ensured that physicians and facilities can provide the benefits of Omidria to their patients without coverage or reimbursement concerns. Quarterly and monthly unit-sales growth rates are high and that trend has continued into the fourth quarter, with Omidria sales revenue now more than covering Omidria-related sales, marketing and manufacturing costs and providing funding for pipeline development. OMS721 has continued to generate positive data in the Phase 2 TMA program, and we are expanding clinical indications beginning with IgA nephropathy and then moving to additional lectin-mediated disorders. With Omidria sales increasing, the OMS721 program expanding, OMS824 headed back to the clinic and the rest of the pipeline advancing, the rest of this year and 2016 promise to be exciting."
Third Quarter and Recent Highlights and Developments
For the quarter ended September 30, 2015, revenue was $3.3 million, including $3.2 million of Omidria product sales. Omidria units shipped by the company's wholesalers during the third quarter increased by 71% from the prior quarter based on data received from wholesalers. Net revenue per vial sold, including all gross-to-net adjustments, remained unchanged from the second quarter. Wholesaler buying patterns in the third quarter are responsible for the significant difference between reported revenues and wholesaler units shipped to ASCs and hospitals, with wholesalers at the end of the quarter holding minimal inventory. The increase in units shipped by the wholesalers reflects growth in customer base, order frequency and average order size.
Total costs and expenses, including noncash expenses, for the three months ended September 30, 2015 were $22.6 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 U.S. commercial launch of Omidria and increased research and development activities related to OMS721.
For the three months ended September 30, 2015, Omeros reported a net loss of $19.9 million, or $0.53 per share, which included noncash expenses of $2.7 million ($0.07 per share). This compares to a net loss of $18.3 million, or $0.54 per share, for the same period in 2014, which included noncash expenses of $2.6 million ($0.08 per share).
At September 30, 2015, Omeros had cash, cash equivalents and short-term investments of $35.0 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 European Union, 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 five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington's disease, schizophrenia, 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.
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, 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 November 9, 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 3,244 | $ | - | $ | 6,607 | $ | - | ||||||||
| Grant revenue | 15 | 214 | 227 | 359 | ||||||||||||
| Total revenue | 3,259 | 214 | 6,834 | 359 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product sales | 248 | - | 624 | - | ||||||||||||
| Research and development | 13,264 | 11,772 | 33,482 | 36,196 | ||||||||||||
| Selling, general and administrative | 9,048 | 5,574 | 25,926 | 14,196 | ||||||||||||
| Total costs and expenses | 22,560 | 17,346 | 60,032 | 50,392 | ||||||||||||
| Loss from operations | (19,301 | ) | (17,132 | ) | (53,198 | ) | (50,033 | ) | ||||||||
| Interest expense | (871 | ) | (944 | ) | (2,765 | ) | (2,555 | ) | ||||||||
| Investment income and other income (expense), net | 251 | (251 | ) | 693 | (372 | ) | ||||||||||
| Net loss | $ | (19,921 | ) | $ | (18,327 | ) | $ | (55,270 | ) | $ | (52,960 | ) | ||||
| Basic and diluted net loss per share | $ | (0.53 | ) | $ | (0.54 | ) | $ | (1.48 | ) | $ | (1.61 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 37,923,353 | 34,005,642 | 37,417,915 | 32,945,346 |
CONSOLIDATED BALANCE SHEET DATA
| September 30, | December 31, | |||||||||||
| 2015 | 2014 | |||||||||||
| (unaudited) | ||||||||||||
| Cash, cash equivalents and short-term investments | $ | 34,999 | $ | 6,886 | ||||||||
| Total assets | 41,417 | 11,090 | ||||||||||
| Total current liabilities | 22,273 | 18,431 | ||||||||||
| Notes payable | 28,551 | 32,709 | ||||||||||
| Accumulated deficit | (383,316 | ) | (328,046 | ) | ||||||||
| Total shareholders' equity (deficit) | (9,004 | ) | (42,654 | ) |