Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, announced recent highlights and developments as well as financial results for the first quarter of 2015, which include:
- Successfully completed Omidria controlled launch followed by initiation of broad U.S. launch in first part of April
- Net loss of $18.7 million, or $0.51 per share, which included $2.8 million ($0.08 per share) of non-cash expenses
- Reported clinical improvement in first cohort in OMS721 Phase 2 trial and completed dosing in second cohort; third cohort enrollment now underway
- Closed equity financing in February, receiving $79.1 million in net proceeds
“In the first quarter of 2015, we completed the controlled launch of Omidria, which was successful across all of the assessed parameters – product was quickly and efficiently received by the facilities, reimbursement was confirmed across Medicare Administrative Contractors, and the clinical response was uniformly positive,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “In April, we initiated the broad U.S. launch of Omidria, and are excited to be making this important product widely available to both ophthalmic surgeons and their patients. The commercialization of Omidria, together with the encouraging results in our Phase 2 OMS721 clinical trial in TMA patients and the anticipated re-initiation of our Phase 2 OMS824 clinical program for patients with Huntington’s disease and schizophrenia, should provide a series of potentially value-driving milestones for Omeros throughout the remainder of 2015 and beyond.”
First Quarter and Recent Highlights and Developments
- In February 2015, the company began a controlled launch of Omidria, its first FDA-approved drug product, to a small number of ambulatory surgery centers (ASCs) for the purpose of evaluating Omidria commercialization processes, including those directed to distribution and reimbursement. Omeros subsequently initiated the broad U.S. product launch in the first part of April.
- Omeros’ ongoing OMS721 Phase 2 study in patients with thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS), completed dosing of the first two cohorts, with the second cohort receiving a higher dose than the first. OMS721 is the lead human monoclonal antibody in Omeros’ mannan-binding lectin-associated serine protease-2 (MASP-2) program. As in the first cohort, all patients in the second cohort received OMS721 and improvements were observed across a wide range of markers of TMA disease activity. Following a pre-planned data review by internal and external physicians, the study’s safety committee recommended that the trial advance to the third cohort at a dose higher than both the first and the second cohorts. The company expects to release additional data from the Phase 2 trial later this year.
- Based on the clinical results from the initial cohort in the OMS721 Phase 2 trial, a European investigator requested that Omeros provide extended access to OMS721 for compassionate use in two of the investigator’s patients with TMAs. The presiding European regulatory authority approved this request and the company has shipped OMS721 to continue treatment of those patients.
- Based on the clinical results from the second cohort in the OMS721 Phase 2 trial, another European investigator has requested that Omeros provide extended access to OMS721 for compassionate use in the investigator’s patient with TMA. Efforts are underway in this second country to obtain the approvals necessary to make OMS721 available to the investigator for patient use.
- Omeros finalized the evaluation of data from nonclinical rat and non-human primate studies in its OMS824 program and submitted the package of nonclinical materials requested by the FDA, seeking to re-initiate its OMS824 Phase 2 Huntington’s disease and schizophrenia programs. The company looks forward to re-activating enrollment in the OMS824 program in the near future.
- In February 2015, Omeros closed a public equity offering of common stock and pre-funded warrants through which the company received net proceeds of approximately $79.1 million.
For the quarter ended March 31, 2015, product revenue from the controlled launch of Omidria was $238,000, and grant revenue was $150,000 compared to $100,000 for the same period in 2014.
Total costs and operating expenses for the three months ended March 31, 2015 were $18.3 million compared to $15.8 million for the same period in 2014. The increase was primarily due to expenses related to the initiation of sales and marketing costs in anticipation of the U.S. commercial launch of Omidria.
Omeros reported a net loss of $18.7 million, or $0.51 per share, which included noncash expenses of $2.8 million ($0.08 per share). This compares to a net loss of $16.6 million, or $0.54 per share, for the same period in 2014, which included noncash expenses of $2.7 million ($0.09 per share).
At March 31, 2015, Omeros had cash, cash equivalents and short-term investments of $70.1 million. (Original Source)
Shares of Omeros closed today at $21.06, up $0.26 or 1.25%. OMER has a 1-year high of $27.64 and a 1-year low of $9.76. The stock’s 50-day moving average is $23.02 and its 200-day moving average is $21.89.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on April 14, MLV & Co. analyst Ram Selvaraju maintained a Buy rating on OMER, with a price target of $38, which implies an upside of 82.3% from current levels. Separately, on the same day, Wedbush’s Liana Moussatos reiterated a Buy rating on the stock and has a price target of $61.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Liana Moussatos have a total average return of 12.6% and 38.8% respectively. Selvaraju has a success rate of 49.6% and is ranked #323 out of 3596 analysts, while Moussatos has a success rate of 56.5% and is ranked #14.
In total, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $20.85 which is 93.0% above where the stock opened today.
Omeros Corp is engaged in the discovery, development and commercialization of pharmaceutical products for inflammation, coagulopathies and disorders of the central nervous system.