Omeros Corporation (NASDAQ: OMER), 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, disorders of the central nervous system and immune-related diseases, including cancers, today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2018, which include:
“We’re pleased with the record OMIDRIA sales in the fourth quarter, which, together with stronger than historical demand for the product in January and February, form the basis for our expectations of substantial growth through 2019,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Adding to our success with OMIDRIA, we have significantly advanced narsoplimab, our MASP-2 inhibitor, toward what we anticipate will be its first in a line of approvals, with our team currently preparing a BLA for stem cell-associated TMA. Behind stem-cell TMA, narsoplimab is in Phase 3 trials for IgA nephropathy and for aHUS, and we anticipate success here as well. OMS527 for addiction is in a Phase 1 clinical program, and our MASP-3 inhibitor, OMS906, and small-molecule inhibitor of MASP-2 are slated to enter the clinic next year. We’ve also expanded our pipeline into immuno-oncology with antagonists against GPR174, a novel target that, based on our animal and ex-vivo human data, increasingly appears to control a critical axis in the treatment of cancers. Across our programs, 2019 looks to be a year of tremendous achievements that we expect will ultimately improve – and save – patients’ lives.”
Fourth Quarter and Recent Developments
Financial Results
Fourth Quarter 2018
For the quarter ended December 31, 2018, revenues were $22.0 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $13.8 million for the same period in 2017. On a sequential quarter-over-quarter basis, OMIDRIA revenue increased by $17.4 million from the third quarter of 2018. The increase from the prior periods reflects strong demand for OMIDRIA from ASCs and hospitals following reinstatement of pass-through reimbursement on October 1, 2018.
Total operating costs and expenses for the three months ended December 31, 2018 were $40.5 million compared to $27.9 million for the same period in 2017. The change in the current year quarter was primarily due to increased research and development spending, which includes manufacturing scale-up costs, as we continue to advance narsoplimab for the treatment of HSCT-TMA towards regulatory submission in the U.S. and Europe, incremental Phase 3 clinical costs for our narsoplimab program in IgA nephropathy and increased Phase 1 clinical costs for OMS527, our PDE7 program for addiction and compulsive disorders.
For the three months ended December 31, 2018, Omeros reported a net loss of $23.5 million, or $0.48 per share, which included non-cash expenses of $4.9 million ($0.10 per share). This compares to the prior year’s fourth quarter when Omeros reported a net loss of $16.6 million, or $0.34 per share, which included non-cash expenses of $4.5 million ($0.09 per share).
At December 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $60.5 million.
In November 2018 Omeros issued $210.0 million of 6.25 percent unsecured Convertible Senior Notes due November 15, 2023. Concurrently, Omeros entered into a capped call transaction significantly reducing the potential dilution if the convertible notes are settled in common shares, and repaid all amounts then outstanding under its existing notes payable. Omeros recorded a one-time $13.0 million charge on early extinguishment of debt and a $13.0 million income tax benefit in the quarter ended December 31, 2018.
Full Year 2018
Revenues for the full year 2018 were $29.9 million, a decrease of 53.9 percent compared to $64.8 million for the full year 2017. The decrease in OMIDRIA revenue in 2018 was primarily attributable to the lack of separate payment for OMIDRIA under Medicare Part B from January 1, 2018 through September 30, 2018.
Total operating costs and expenses for the year ended December 31, 2018 were $142.1 million, an increase of $33.4 million compared to 2017. The increase from the prior year related primarily to higher third-party manufacturing scale-up costs for our narsoplimab program as we continue to increase our production capacity to meet anticipated clinical and commercial requirements, as well as higher costs associated with initiation of our Phase 3 clinical trial of narsoplimab in IgA nephropathy and our Phase 1 clinical trial for OMS527, our PDE7 program for addiction and compulsive disorders.
For the full year 2018, Omeros reported a net loss of $126.8 million, or $2.61 per share, including non-cash expenses of $18.7 million, or $0.39 per share. This compares to a net loss of $53.5 million, or $1.17 per share in 2017, including non-cash expenses of $17.4 million, or $0.38 per share.
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 5:30 a.m. Pacific Time; 8:30 a.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 3544038. 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 3544038.
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, disorders of the central nervous system and immune-related diseases, including cancers. 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, 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,” “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 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2019. 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 |
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UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share data) |
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Three Months Ended | Twelve Months Ended | ||||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Product sales, net | $ | 22,017 | $ | 13,760 | $ | 29,868 | $ | 64,826 | |||||||||||||
Costs and expenses: | |||||||||||||||||||||
Cost of product sales | 157 | 466 | 512 | 1,078 | |||||||||||||||||
Research and development | 25,446 | 15,387 | 89,860 | 55,599 | |||||||||||||||||
Selling, general and administrative | 14,888 | 12,028 | 51,718 | 52,044 | |||||||||||||||||
Total costs and expenses | 40,491 | 27,881 | 142,090 | 108,721 | |||||||||||||||||
Loss from operations | (18,474 | ) | (14,121 | ) | (112,222 | ) | (43,895 | ) | |||||||||||||
Loss on early extinguishment of debt | (12,993 | ) | — | (12,993 | ) | — | |||||||||||||||
Interest expense | (5,149 | ) | (2,864 | ) | (16,252 | ) | (11,030 | ) | |||||||||||||
Other income | 153 | 434 | 1,781 | 1,444 | |||||||||||||||||
Loss before income taxes | (36,463 | ) | (16,551 | ) | (139,686 | ) | (53,481 | ) | |||||||||||||
Income tax benefit | 12,929 | — |
12,929 |
— | |||||||||||||||||
Net loss | $ | (23,534 | ) | $ | (16,551 | ) | $ | (126,757 | ) | $ | (53,481 | ) | |||||||||
Basic and diluted net loss per share | $ | (0.48 | ) | $ | (0.34 | ) | $ | (2.61 | ) | $ | (1.17 | ) | |||||||||
Weighted-average shares used to compute basic and diluted net loss per share |
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49,010,677 |
48,029,195 | 48,582,636 | 45,539,362 |
OMEROS CORPORATION |
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UNAUDITED CONSOLIDATED BALANCE SHEET DATA |
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(In thousands) |
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December 31, | December 31, | ||||||||
2018 | 2017 | ||||||||
Cash, cash equivalents and short-term investments | $ | 60,498 | $ | 83,749 | |||||
Working capital | 52,511 | 82,065 | |||||||
Restricted investments | 1,154 | 5,835 | |||||||
Total assets | 95,936 | 116,328 | |||||||
Total current liabilities | 37,356 | 26,307 | |||||||
Notes payable and lease financing obligations, net |
2,467 | 84,117 | |||||||
Unsecured convertible senior notes, net | 148,981 | — | |||||||
Accumulated deficit | 650,125 | 523,368 | |||||||
Total shareholders’ deficit | 100,156 | 2,814 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190301005211/en/
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor
and Media Relations
360.668.3701
[email protected]