Omeros Corporation (NASDAQ: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2018, which include:
“During the last quarter, we made significant strides across multiple fronts,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “For OMS721, our MASP-2 inhibitor, Phase 3 clinical trials are advancing in both IgA nephropathy and aHUS, and our stem-cell TMA program is moving toward regulatory filings for marketing approval in both the U.S. and Europe. Our PDE7 inhibitor OMS527 is demonstrating good drug behavior in its Phase 1 clinical trial. We are also excited about our MASP-3 inhibitor OMS906, our MASP-2 small molecules for oral administration and our multiple GPCR cancer therapeutic programs, all of which look promising and are slated to begin entering the clinic as early as late 2019. And to help fund our pipeline’s continuing progress, OMIDRIA is rapidly approaching its return to pass-through status on October 1. All of the pieces appear to be coming together, and we look forward to realizing the near- and long-term prospects for Omeros.”
Second Quarter and Recent Developments
Financial Results
For the quarter ended June 30, 2018, revenues were $1.7 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $17.2 million for the same period in 2017. The decrease in revenue from the comparable quarter in 2017 was due to the significantly reduced usage of OMIDRIA by ASCs and hospitals during the period (January 1, 2018 through September 30, 2018) in which transitional pass-through reimbursement for OMIDRIA is unavailable. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $0.1 million from the $1.6 million achieved in the first quarter of 2018. Pass-through status for OMIDRIA will reinitiate on October 1, 2018 and is scheduled to remain in effect through September 30, 2020.
Total costs and expenses for the three months ended June 30, 2018 were $32.3 million compared to $29.1 million for the same period in 2017. The increase in the current year quarter was primarily due to higher manufacturing scale-up costs for the OMS721 programs and to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial. These increases were partially offset by decreased OMIDRIA patent litigation costs.
For the three months ended June 30, 2018, Omeros reported a net loss of $33.7 million, or $0.70 per share, which included non-cash expenses of $4.6 million ($0.10 per share). In comparison, for the prior year’s second quarter Omeros reported a net loss of $14.4 million, or $0.33 per share including non-cash expenses of $4.3 million ($0.10 per share).
As of June 30, 2018, the company had $88.4 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments. This includes the remaining $45.0 million available under the company’s existing credit facility, which was drawn down in May 2018.
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 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 3989669. 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 3989669.
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.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system. The company’s drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed 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 other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,” “should,” “slated,” “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, 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 9, 2018. 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 CORPORATION | ||||||||||||||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenue: | ||||||||||||||||||||
Product sales, net | $ | 1,655 | $ | 17,151 | $ | 3,244 | $ | 29,408 | ||||||||||||
Costs and expenses: | ||||||||||||||||||||
Cost of product sales | 116 | 157 | 319 | 429 | ||||||||||||||||
Research and development | 19,412 | 13,137 | 37,551 | 25,377 | ||||||||||||||||
Selling, general and administrative | 12,744 | 15,796 | 23,678 | 28,267 | ||||||||||||||||
Total costs and expenses | 32,272 | 29,090 | 61,548 | 54,073 | ||||||||||||||||
Loss from operations | (30,617 | ) | (11,939 | ) | (58,304 | ) | (24,665 | ) | ||||||||||||
Interest expense | (3,676 | ) | (2,723 | ) | (6,502 | ) | (5,386 | ) | ||||||||||||
Other income | 597 | 303 | 1,056 | 603 | ||||||||||||||||
Net loss | $ | (33,696 | ) | $ | (14,359 | ) | $ | (63,750 | ) | $ | (29,448 | ) | ||||||||
Comprehensive loss | $ | (33,696 | ) | $ | (14,359 | ) | $ | (63,750 | ) | $ | (29,448 | ) | ||||||||
Basic and diluted net loss per share | $ | (0.70 | ) | $ | (0.33 | ) | $ | (1.32 | ) | $ | (0.67 | ) | ||||||||
Weighted-average shares used to compute basic and diluted net loss per share |
48,384,460 | 44,037,471 | 48,333,610 | 43,933,022 | ||||||||||||||||
OMEROS CORPORATION | ||||||||||
UNAUDITED CONSOLIDATED BALANCE SHEET DATA | ||||||||||
(In thousands) | ||||||||||
June 30, |
December 31, |
|||||||||
Cash, cash equivalents and short-term investments | $ | 88,404 | $ | 83,749 | ||||||
Working capital | 72,062 | 82,065 | ||||||||
Restricted investments | 5,779 | 5,835 | ||||||||
Total assets | 106,349 | 116,328 | ||||||||
Total current liabilities | 24,442 | 26,307 | ||||||||
Notes payable and lease financing obligations, net | 130,358 | 84,607 | ||||||||
Accumulated deficit | (587,118 | ) | (523,368 | ) | ||||||
Total shareholders’ deficit | (56,297 | ) | (2,814 | ) | ||||||
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Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
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