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 financial results and highlights for the second quarter of 2014, which include:
- 2Q 2014 net loss of $18.0 million, or $0.53 per share, which included $2.5 million ($0.07 per share) of non-cash expenses
- Operating expenses of $17.3 million, primarily related to preparing for U.S. commercial launch of Omidria™ and advancing OMS824 and OMS721 clinical programs
- U.S. Food and Drug Administration (FDA) approval of Omidria™ (phenylephrine and ketorolac injection) 1%/0.3% 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
- FDA clearance of Investigational New Drug (IND) application for Phase 2 clinical trial evaluating OMS721 in thrombotic microangiopathies (TMAs) and initiated Phase 2 trial
"Obtaining U.S. marketing approval for Omidria is a tremendous accomplishment for Omeros," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "It marks a pivotal point in our transition to a commercial company, and we are continuing preparations for a planned U.S. product launch in the fourth quarter of 2014. In that same time frame, we also expect to receive a decision on the EU marketing application for Omidria. While we remain focused on the market launch of Omidria, we continue to advance the rest of our pipeline, including our MASP-2 inhibitor OMS721 and PDE10 inhibitor OMS824 Phase 2 clinical programs in patients with TMAs and Huntington's, respectively. We expect preliminary data from each of those Phase 2 trials later this year."
Second Quarter and Recent Highlights
- FDA granted marketing approval to Omidria (phenylephrine and ketorolac injection) 1%/0.3% on May 30, 2014 for use during cataract surgery or ILR to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. The only post-marketing commitment required is the previously agreed upon study of Omidria for use in pediatric patients, which, if successfully completed according to FDA's Written Request, makes Omidria eligible for an additional six months of marketing exclusivity in the U.S. The company expects first patient enrollment in this trial in the latter part of the third quarter.
- Continued preparations for the commercial launch of Omidria in the U.S., including hiring sales and marketing management teams and contracting for field sales representatives to call on surgeons, hospitals and ambulatory surgery centers beginning in August 2014. The company expects to begin commercial sales of Omidria in the fourth quarter of 2014.
- Announced that the FDA cleared Omeros' IND application to evaluate OMS721 for the inhibition of complement-mediated TMAs in a Phase 2 clinical trial, which is currently underway.
For the quarter ended June 30, 2014, Omeros reported a net loss of $18.0 million, or $0.53 per share. This compares to a net loss of $13.6 million or $0.48 per share, for the same period in 2013. Noncash expenses were $2.5 million ($0.07 per share) for the quarter ended June 30, 2014 and $2.2 million ($0.08 per share) for the same period in 2013.
Operating expenses for the three months ended June 30, 2014 were $17.3 million compared to $13.3 million for the same period in 2013. The increase was primarily related preparing for the U.S. commercial launch of Omidria later this year and to manufacturing of material and clinical costs associated with the Phase 2 clinical trials evaluating OMS721 in TMAs and OMS824 in Huntington's disease.
Revenue for the quarter ended June 30, 2014 was $45,000 compared to $140,000 for the same period in 2013. This decrease was due to a reduction of activity on NIH grant projects, which resulted in lower revenue being recognized.
At June 30, 2014, Omeros had cash and cash equivalents and short-term investments of $37.5 million.