Full Press Release Details
Omeros Corporation Reports Third Quarter 2014 Financial Results
Omidria U.S. Commercial Launch Planned for Early 2015
SEATTLE November 10, 2014 Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and
commercializing 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 2014, which include:
The clarity on pass-through reimbursement received from CMS has allowed us to solidify our U.S. commercialization plans for Omidria, and we appreciate
both the agency s collaborative process and its favorable decision, said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. U.S. launch preparations are nearly complete and we look forward to making the drug
available to surgeons and their patients in early 2015. The European approval process is also advancing, and we expect to receive CHMP s opinion for Omidria before year-end. Additional near-term milestones for Omeros include thrombus data from
the human ex vivo pathophysiologic system of aHUS and the release of preliminary results from our OMS721 Phase 2 clinical trial in thrombotic microangiopathies. We also look forward to re-activating enrollment in our OMS824 Phase 2 clinical
program. The next few months and the whole of 2015 promise to be exciting times for Omeros and our shareholders.
Recent Highlights and Developments
For the quarter ended
September 30, 2014, Omeros reported a net loss of $18.3 million, or $0.54 per share, which includes noncash expenses of $2.5 million ($0.07 per share). This compares to a net loss of $13.9 million, or $0.46 per share, for the same period in
2013, including noncash expenses of $3.4 million ($0.11 per share).
Operating expenses for the three months ended September 30, 2014 were $17.3
million compared to $13.6 million for the same period in 2013. The increase was primarily related to preparing for the U.S. commercial launch of Omidria, manufacturing of drug material associated with the Phase 2 clinical trials evaluating OMS824 in
Huntington s disease, and clinical costs associated with the Phase 2 clinical trials evaluating OMS721 in complement-mediated thrombotic microangiopathies.
Revenue for the quarter ended September 30, 2014 was $214,000 compared to $196,000 for the same period in 2013. This increase was due to a rise in
activity on NIH grant projects.
At September 30, 2014, Omeros had cash and cash equivalents and short-term investments of $21.8 million.
Management to Host Earnings Call Today at 4:30pm ET
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 31107196. 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 31107196.
To access the live and 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 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 replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. Omeros is completing preparations for a planned U.S. product launch in early 2015. Omidria is currently under review for marketing approval by the European Medicines Agency. Omeros also has six
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 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, risks associated with effectiveness of Omidria sales and marketing efforts, Omidria market acceptance, product pricing and reimbursement, Omeros ability to
obtain regulatory approval for its Marketing Authorization Application and to partner in the EU for the commercialization of Omidria, Omeros unproven preclinical and clinical development activities, regulatory oversight, product
commercialization, 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 10, 2014. 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
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenue | $ | 214 | $ | 196 | $ | 359 | $ | 1,431 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 11,772 | 9,420 | 36,196 | 26,111 | ||||||||||||
| Selling general and administrative | 5,574 | 4,210 | 14,196 | 11,934 | ||||||||||||
| Total operating expenses | 17,346 | 13,630 | 50,392 | 38,045 | ||||||||||||
| Loss from operations | (17,132 | ) | (13,434 | ) | (50,033 | ) | (36,614 | ) | ||||||||
| Investment income | 3 | 2 | 10 | 10 | ||||||||||||
| Interest expense | (944 | ) | (592 | ) | (2,555 | ) | (1,768 | ) | ||||||||
| Other income (expense), net | (254 | ) | 154 | (382 | ) | 421 | ||||||||||
| Net loss | $ | (18,327 | ) | $ | (13,870 | ) | $ | (52,960 | ) | $ | (37,951 | ) | ||||
| Basic and diluted net loss per share | $ | (0.54 | ) | $ | (0.46 | ) | $ | (1.61 | ) | $ | (1.36 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 34,005,642 | 29,844,507 | 32,945,346 | 27,984,133 |
CONSOLIDATED BALANCE SHEET DATA
| September 30, 2014 | December 31, 2013 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents and short-term investments | $ | 21,780 | $ | 14,101 | ||||
| Total assets | 25,294 | 16,535 | ||||||
| Total notes payable | 32,542 | 20,498 | ||||||
| Total current liabilities | 14,397 | 11,873 | ||||||
| Accumulated deficit | (307,333 | ) | (254,373 | ) | ||||
| Total shareholders deficit | (26,589 | ) | (18,384 | ) |