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Monday, January 14, 2019

Omeros reports preliminary Q4 revenue $22M, consensus $13.94M


Omeros’ preliminary total and OMIDRIA 1% / 0.3% revenues for the fourth quarter of 2018 are expected to be a record high at approximately $22.0 million compared to $4.6 million in 3Q18 and $13.8 million in the prior year fourth quarter. The increase from the prior periods reflects strong demand for OMIDRIA from ambulatory surgery centers and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018. Consistent with Omeros’ strategy, growing revenues from OMIDRIA are increasingly funding the progress across the company’s pipeline, including the advancement of its OMS721 Phase 3 program in hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA. As reflected in an update recently submitted to clinicaltrials.gov, Omeros plans to keep the ongoing HSCT-TMA registration trial open through the submission, filing and review of the Biologics License Application, or BLA, and the Marketing Authorization Application, or MAA, in the U.S. and Europe, respectively, to collect additional data. These data are expected to help provide healthcare professionals and payers with additional supporting information on the clinical use and value of OMS721 once approved. The update submitted by Omeros to clinicaltrials.gov has no effect on the overall timing, content or requirements of the OMS721 HSCT-TMA program, including the BLA and MAA, and the program remains on track. “We are very pleased that demand for OMIDRIA, in its first quarter of restored separate payment, has not only returned quickly to the levels experienced prior to the expiration of pass-through reimbursement but that quarterly revenue and sell-through results are already setting new high-water marks,” said Gregory Demopulos, M.D., Omeros’ chairman and CEO. “We are also encouraged by the expanding coverage seen by commercial and Medicare Advantage payers and, with the addition of OMIDRIA to its national formulary, by the VA. All of these data underscore the importance both of improved outcomes with OMIDRIA and of separate payment to ensuring patient access to the drug’s benefits. As expected, revenues from sales of OMIDRIA ramped up throughout the fourth quarter, and we look forward to continued revenue growth in 2019 as we prepare to commercialize OMS721 for the treatment of stem cell transplant-associated TMA.”
https://thefly.com/landingPageNews.php?id=2848043

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