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 fourth quarter and year ended December 31, 2015, which include:
- For 4Q 2015, sales revenues of OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% were$6.7 million, a 105% increase over 3Q, with OMIDRIA units shipped by wholesalers (“sell-through”) increasing 74% over 3Q.
- 2015 revenues were $13.5 million, $13.3 million of which were from OMIDRIA sales following broad U.S. launch in April 2015.
- Net loss in 4Q 2015 was $19.8 million, or $0.52 per share, and, for the full year of 2015, was$75.1 million, or $2.00 per share. Both periods include a $1.3 million ($0.03 per share in 4Q) charge for early extinguishment of previously existing debt. In addition, non-cash expenses for 4Q and the full year of 2015 were $2.8 million, or $0.07 per share, and $11.0 million, or $0.29 per share, respectively.
- Expanded Phase 2 OMS721 clinical trials to include immunoglobulin A (IgA) nephropathy and other complement-related renal disorders.
- Launched OMIDRIAssure™ Reimbursement Services Program to expand patient access to OMIDRIA.
- Closed secured credit facility in December 2015, receiving $22.3 million in net proceeds with an additional $20.0 million available dependent on achieving certain OMIDRIA revenues.
“We are pleased with the quarter-over-quarter growth in OMIDRIA sales and look forward to accelerating sales in 2016 now that we have a full cadre of ‘in-house’ sales representatives, broader regional access across the U.S. and increasing utilization of our OMIDRIAssure program by surgeons and facilities nationwide,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Our pipeline continues to make significant strides, expanding our OMS721 Phase 2 program to include IgA nephropathy and other renal disorders, continuing to advance OMS824 in Huntington’s disease and preparing to move both OMS527, our PDE7 inhibitor for the treatment of addictions, and OMS616, our plasmin inhibitor to treat bleeding disorders, into the clinic in 2017. These developments, together with continued progress in our MASP-3 and GPCR programs, promise to make 2016 an exciting year for Omeros.”
Fourth Quarter and Recent Highlights and Developments
- Highlights and developments regarding OMS721, the company’s lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS), include:
- Based on the positive efficacy and safety data in TMAs as well as the known biology of complement-related renal disorders, Omeros is currently expanding clinical trials to evaluate OMS721 in IgA nephropathy and other complement-related renal disorders.
- Physicians in Finland, based on review of OMS721 data, requested access to OMS721 under a Special License, granted by the Finnish regulatory authorities, for compassionate use in a patient with aHUS. The patient was previously treated with Soliris® (eculizumab) but did not have an adequate response according to the requesting physicians and was continuing to display signs of active aHUS.
- To help ensure that patients, surgeons and facilities can access the benefits of OMIDRIA, Omerosintroduced the OMIDRIAssure™ Reimbursement Services Program in 4Q 2015 with comprehensive reimbursement services including two patient assistance programs to cover the cost of OMIDRIA: (1) the “Equal Access” Patient Assistance Program for financially eligible government-insured and uninsured patients and (2) the “We Pay the Difference” Commercial Reimbursement Program for patients with insufficient commercial insurance.
- An additional U.S. Patent directed to methods of using OMIDRIA was granted to Omeros and will issue on March 8, 2016. This additional patent was granted by the U.S. Patent and Trademark Office after the Patent Office considered all prior art that was identified by Par Sterile Products, LLC and Par Pharmaceutical, Inc., or Par, in its Paragraph IV Notice Letter concerning its Abbreviated New Drug Application requesting FDA approval for a generic version of OMIDRIA, which could be approved no earlier than the end of January 2018 while the company’s lawsuit against Par is pending. Omeros will seek leave to amend its complaint for patent infringement against Par to enforce this patent in addition to the three other OMIDRIA patents already included in Omeros’ complaint.
- A U.S. Patent was granted to Omeros that is directed to the use of any phosphodiesterase-7, or PDE7, inhibitor to treat any substance addiction or any addictive or compulsive behavior. Omerosexpects to advance its OMS527 PDE7 inhibitor program into the clinic in 2017.
- The company closed a $70.0 million secured credit facility with Oxford Finance and East West Bank (Credit Facility), receiving $22.3 million in net proceeds at closing. Omeros has the ability, subject to the satisfaction of certain conditions including the achievement of net revenue milestones for OMIDRIA, to access the final $20.0 million of the credit facility in two tranches until June 30, 2017.
- Omeros hired 26 of its previously contracted OMIDRIA field sales representatives effective January 1, 2016. The remaining territories were filled by hiring additional seasoned representatives, many with focused ophthalmology experience. Omeros currently employs 37 dedicated sales representatives. In January 2016, Omeros also entered into a commission-only contract sales agent agreement with Precision Lens to cover territories in the Midwest that are not covered by the company’s in-house sales force.
Fourth Quarter 2015
For the quarter ended December 31, 2015, OMIDRIA product sales revenue was $6.7 million. This compares to grant revenue of $180,000 for the same period in 2014. OMIDRIA units sold by the company’s wholesalers to ambulatory surgery centers (ASCs) and hospitals increased 74% from the third quarter, reflecting broad-based increases across average daily sales, average number of daily orders, average number of vials per order and new accounts.
Total costs and expenses for the three months ended December 31, 2015 were $24.7 millioncompared to $20.2 million for the same period in 2014. The increase in the current year quarter was primarily due to increased OMS721 research and development activities and sales and marketing costs associated with the 2015 U.S. commercial launch of OMIDRIA.
In December 2015, the company incurred a $1.3 million loss ($0.03 per share) on early extinguishment of debt associated with the initiation of a new secured credit facility and the prepayment of Omeros’ prior secured credit facility.
For the three months ended December 31, 2015, Omeros reported a net loss of $19.8 million, or$0.52 per share, which included noncash expenses of $2.8 million ($0.07 per share). This compares to a net loss of $20.7 million, or $0.61 per share, for the same period in 2014, which included noncash expenses of $4.2 million ($0.12 per share).
At December 31, 2015, the company had cash, cash equivalents and short-term investments of$28.3 million. In addition, the company had $10.0 million of restricted cash on hand to satisfy its Credit Facility covenant.
Full Year 2015
Revenue for the full year 2015 was $13.5 million, comprised in total of $13.3 million of OMIDRIA product sales and $245,000 in grant revenue, compared to $539,000 in grant revenue for the full year 2014.
Total costs and expenses for the year ended December 31, 2015 were $84.7 million, an increase of$14.2 million compared to 2014. The 2015 increase related primarily to additional expenses in connection with the U.S. commercial launch of OMIDRIA and to increased employee costs.
For the full year 2015, Omeros reported a net loss of $75.1 million or $2.00 per share, including non-cash expenses of $11.0 million or $0.29 per share. This compares to a net loss of $73.7 millionor $2.22 per share in 2014, including non-cash expenses of $11.7 million or $0.35 per share. (Original Source)
Shares of Omeros opened today at $12.99. OMER has a 1-year high of $30.23 and a 1-year low of $8.90. The stock’s 50-day moving average is $10.72 and its 200-day moving average is $12.95.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on February 24, Maxim Group analyst Jason McCarthy reiterated a Buy rating on OMER, with a price target of $30, which represents a potential upside of 130.9% from where the stock is currently trading. Separately, on November 10, Needham’s Serge Belanger maintained a Buy rating on the stock and has a price target of $30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Serge Belanger have a total average return of -11.0% and 8.6% respectively. McCarthy has a success rate of 36.8% and is ranked #3516 out of 3698 analysts, while Belanger has a success rate of 37.0% and is ranked #724.
Omeros Corp is engaged in the discovery, development and commercialization of pharmaceutical products for inflammation, coagulopathies and disorders of the central nervous system.