Full Press Release Details
Omeros Corporation Reports Third Quarter 2019 Financial Results
Conference Call Today at 4:30 p.m. ET
SEATTLE, WA November 12, 2019 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 third quarter ended September 30, 2019.
Third Quarter 2019 Financial Highlights
3Q 2019 revenues were $29.9 million, another quarter of record sales of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. This compares to $26.8 million in 2Q 2019, an increase of $3.1 million, or 12 percent.
Recent Business Highlights
Initiating submission of our rolling BLA for narsoplimab in stem cell transplant-associated TMA is a significant milestone on our path to becoming a multi-product commercial biopharmaceutical company and, more importantly, is a major advance in our mission to treat these patients, said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. We are on track to complete submission of our BLA in the first half of 2020 and preparations for the anticipated commercial launch of narsoplimab are also progressing. We continue to grow utilization of OMIDRIA, delivering record quarterly sales in Q3 and projecting a new all-time high in the fourth quarter. The remainder of our pipeline assets are also progressing OMS527 has successfully completed its Phase 1 trial in our addiction program, our MASP-3 inhibitor OMS906 is on track to enter the clinic in the first half of next year, and our GPR174 immuno-oncology program continues to generate exciting new in vivo data, which will be presented for the first time later this month at the AACR conference in Boston.
Other Business Updates and Developments
Recent developments regarding OMIDRIA include the following:
Recent developments regarding narsoplimab, Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:
Updates regarding Omeros' other development programs and platforms include the following:
3Q 2019 revenues, all related to sales of OMIDRIA, were $29.9 million, a new record high. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $3.1 million, or 12 percent, from the $26.8 million achieved in 2Q 2019. The increase is due to a growing number of purchasing accounts as well as deeper penetration within accounts across hospitals, ASCs, Veterans Administration and other government payers.
Gross-to-net deductions in 3Q 2019 remained consistent with those in 2Q 2019 at 28 percent
3Q 2019 costs and expenses were $41.0 million compared to $36.1 million for Q2 2019. The increase reflected incremental narsoplimab manufacturing costs associated with the commencement of full-scale drug substance manufacturing in 3Q 2019 together with increased manufacturing scale-up costs in our OMS906 program in advance of planned clinical entry next year. Selling, general and administrative expenses were $16.9 million for both 2Q and 3Q 2019.
For 3Q 2019, Omeros reported a net loss of $16.5 million, or $0.33 per share, compared to a net loss of $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in both 2Q 2019 and 3Q 2019 included non-cash expenses of $6.3 million ($0.13 per share).
As of September 30, 2019, Omeros had $27.3 million of cash, cash equivalents and short-term investments available for operations, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.
Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019, there were no borrowings outstanding.
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 9699377. 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 9699377.
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 an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial drug OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse, as well as a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. 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, objective, plan, potential, predict, project, should, slate, target, 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, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, 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, as supplemented from time to time by the company's Quarterly Reports on Form 10-Q. 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.
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||
| Revenue: | |||||||||||||
| Product sales, net | $ | 29,856 | $ | 4,608 | $ | 78,389 | $ | 7,852 | |||||
| Costs and expenses: | |||||||||||||
| Cost of product sales | 278 | 36 | 464 | 355 | |||||||||
| Research and development | 23,746 | 26,862 | 69,108 | 64,414 | |||||||||
| Selling, general and administrative | 16,933 | 13,152 | 48,493 | 36,830 | |||||||||
| Total costs and expenses | 40,957 | 40,050 | 118,065 | 101,599 | |||||||||
| Loss from operations | (11,101) | (35,442) | (39,676) | (93,747) | |||||||||
| Interest expense | (5,715) | (4,602) | (16,846) | (11,104) | |||||||||
| Other income | 353 | 572 | 1,261 | 1,628 | |||||||||
| Net loss | $ | (16,463) | $ | (39,472) | $ | (55,261) | $ | (103,223) | |||||
| Comprehensive loss | $ | (16,463) | $ | (39,472) | $ | (55,261) | $ | (103,223) | |||||
| Basic and diluted net loss per share | $ | (0.33) | $ | (0.81) | $ | (1.12) | $ | (2.13) | |||||
| Weighted-average shares used to compute basic and diluted net loss per share | 49,373,156 | 48,647,416 | 49,157,055 | 48,437,870 |
UNAUDITED CONSOLIDATED BALANCE SHEET DATA
| September 30, 2019 | December 31, 2018 | ||||||
| Cash, cash equivalents and short-term investments | $ | 27,342 | $ | 60,498 | |||
| Working capital | 17,046 | 52,511 | |||||
| Restricted investments | 1,154 | 1,154 | |||||
| Total assets | 91,263 | 95,936 | |||||
| Total current liabilities | 46,753 | 37,356 | |||||
| Lease liabilities | 31,709 | 2,467 | |||||
| Convertible Senior Notes | 155,771 | 148,981 | |||||
| Accumulated deficit | (705,386) | (650,125) | |||||
| Total shareholders' deficit | (139,915) | (100,156) |