On January 14, 2019 Omeros Corporation (Nasdaq: OMER), reported unaudited preliminary revenue results for the fourth quarter ended December 31, 2018 (Press release, Omeros, JAN 14, 2019, View Source [SID1234532632]).

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Omeros’ preliminary (unaudited) total and OMIDRIA (phenylephrine and ketorolac intraocular solution) 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 3Q 2018 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 (ASCs) and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018.

As of December 31, 2018, days of wholesaler inventory on hand were consistent with historical norms.

Increased utilization within commercial insurance and Veterans Health Administration systems contributed to the increased revenues.

Units sold by wholesalers to ASCs and to hospitals (sell-through) as well as the number of purchasing hospital accounts for the fourth quarter 2018 each also represent a record high.

Annualized run rate of weekly net sales in December was approximately $100 million.

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 (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 (BLA) and the Marketing Authorization Application (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 A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "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."

Omeros has released OMIDRIA fourth-quarter preliminary revenues for the purpose of providing transparency in the unique setting of reinstatement of pass-through status and does not currently intend in the future to make public preliminary sales revenues on a routine basis. The company expects to release complete fourth-quarter and full-year 2018 financial results and to host a conference call by March 1, 2019