Omeros Corporation (NASDAQ:OMER), has announced some recent highlights and developments plus financial results for the fourth quarter as well as the year ended December 31, 2017. Omeros Corporation is a commercial-stage pharmaceutical firm, which is committed to discovering, producing and commercializing of small-molecule and protein treatments mainly targeting large-market and orphan indications for curing inflammation, complement-mediated diseases and disorders mainly in the central nervous system
In the fourth quarter, the company reported $13.8 million in revenue. This represents a 36.5 percent decrease compared to what the company reported in the third quarter of 2017. The unit pricing as well as the number of vials, which were sold to ASCs and hospitals, remained the same from the third quarter 2017.
For the full year of 2017, the company reported $64.8 million in revenue. This represents an increase of 55.8% compared to the $41.6 million that was reported in 2016. The increase was as a result of increase in OMIDRIA purchases from the existing customers plus enrolling new customers.
Fourth Quarter and Recent Developments
OMIDRIA’s pass-through status come an end on January 1, 2018, and payment for this product has been included as part of the payment for the associated procedure for Medicare patients. The company believes that a significant number of facilities that used OMIDRIA which are awaiting a determination on the reimbursement by the Centers for Medicare and Medicaid Services (CMS). The company also decided to implement an alternative sales plan which greatly affected sales to wholesalers. Omeros has said that it expect the trend to continue for some time as it normalizes all the uncertainties.
OMIDRIA says it is pursuing administrative and legislative in order to obtain permanent separate payment as well as similar reimbursement for the company and will extend the period for reimbursement from three to five years.
The FDA, in December approved the supplemental new drug application (sNDA) after reviewing the safety and efficacy data from a pediatric clinical trial. This has expanded the indications for the company to incorporate use in pediatric patients. Additionally, the FDA granted the company with an additional period of six months of market exclusivity.
Development of OMS721, the company’s lead human monoclonal antibody which is being developed under the mannan-binding lectin-associated serine protease-2 (MASP-2) programs used in treatment of HCT-TMA, IgA nephropathy and atypical hemolytic uremic syndrome (aHUS) is currently ongoing.