Omeros Corp. (OMER) PT Lowered to $19 at H.C. Wainwright

October 6, 2021 6:48 AM EDT
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Price: $6.40 --0%

Rating Summary:
    9 Buy, 3 Hold, 2 Sell

Rating Trend: Down Down

Today's Overall Ratings:
    Up: 5 | Down: 9 | New: 25
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H.C. Wainwright analyst Raghuram Selvaraju lowered the price target on Omeros Corp. (NASDAQ: OMER) to $19.00 (from $32.00) while maintaining a Buy rating.

The analyst commented, "OMS721 (narsoplimab) is the subject of a Biologics License Application (BLA) that originally was assigned a Prescription Drug User Fee Act (PDUFA) approval decision date of October 17 2021 in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Last week, the FDA notified the company that the agency had identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this juncture. The FDA stated that the notification does not reflect a final decision on the information under review. The agency did not provide details of the deficiencies in its notification; however, in a meeting held on September 30, 2021, the FDA expressed its intention to work with Omeros to resolve any issues as expeditiously as possible. However, we do not anticipate approval to occur by the PDUFA date. At this stage, without further details regarding what might be needed to address the deficiencies identified by the agency, we cannot state with certainty how long it might take for Omeros to obtain U.S. approval of narsoplimab. Accordingly, we have moved our U.S. approval timing for the drug in the HSCT-TMA indication to 2022 and thus removed all narsoplimab revenue contributions from 2021, while instituting a $16M total revenue forecast for narsoplimab in 2022 vs. the prior $57.6M. Our 2022 revenue estimate has therefore declined to $121.5M vs. the prior $163.1M. We do not expect Omeros to be able to attain profitability in 2022. Furthermore, we have decreased our probability of regulatory approval for narsoplimab to 60% vs. the prior 85%. The company's ability to reach cash flow-positive status likely depends upon its securing of approval for narsoplimab. In the wake of these changes, we reiterate our Buy rating, while lowering our 12-month price target to $19 from $32."



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Analyst Comments, Analyst PT Change

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PDUFA, H.C. Wainwright, FDA