Omeros' appeal of the FDA decision was a good decision. With elections looming between now and 2025, the likelihood of passage for the NOPAIN Act is an unanswerable riddle. As is the case for all aspects of this milestone, the answer was responsive, but unhelpful. JP Morgan analyst Joseph asked if there was another path to the milestone aside from the NOPAIN Act. the 98 member new Democrat Coalition one of the largest and most influential caucuses in the House of Representatives has endorsed the NOPAIN Act, making it a key part of the coalition's legislative agenda for this summer. One vehicle through which the $200 million milestone could be achieved is the enactment of the NOPAIN Act, which has been introduced in both chambers of commerce, and would provide separate payment for a renewable period of five years for non-opioid pain management drugs like OMIDRIA in ambulatory surgery centers or ASCs, as well as in hospital outpatient departments or HOPDs. Instead of focusing on the text of the agreement, I am instead reliant on management.ĭuring the Call there were several discussions on this point. if before 2025, separate payment for OMIDRIA is secured for a continuous period of at least four years.Īfter attempting to unravel the exact meaning of the above "milestone event" entitling Omeros to its $200 million as set out in the Asset Purchase Agreement, Exhibit 10.1 to Omeros latest 10-K, I admit defeat. Omeros's $200 million OMIDRIA milestone is a potential bonus that ought not be relied up on.Īs long as I have followed Omeros, the twinkling potential of OMIDRIA has been obfuscated by the vagaries of its Medicare reimbursement status described in detail at the "Risks abound - OMIDRIA" section of "Omeros: Payoffs Beckon, Risks Abound".įrustratingly, Omeros Rayner Surgical deal has carried this issue forward, by providing a $200 million milestone:
Omeros is also in line for a 15% royalty on foreign net sales. The bigger cash benefit would come if Omeros qualified for this $200 million OMIDRIA milestone as discussed below thereafter its US royalty runs at 30% until at least 2033, the expiration of its relevant OMIDRIA patents. This 50% royalty continues until the earlier of Omeros' receipt of its $200 million milestone or. This suggests that once the ball starts rolling OMIDRIA royalties could contribute >$15 million a quarter. OMIDRIA net sales were $27.8 million for Q1, 2022 a year's first quarter has the least volume of cataract surgeries. It did not guide for an expected amount of such revenue that it expects to recognize in Q2, 2022.
In addition to its OMIDRIA receivable, Omeros will be entitled to 50% royalties on Rayner's OMIDRIA revenues for Q2, 2022. Additionally, it reported $16.3 million in OMIDRIA receivables retained as part of the Rayner Surgical deal which it expected to collect in 05/2022. In the Call Omeros reported $142.2 in cash and investments available to support ongoing activities as of. Omeros latest available information comes from its Q1, 2022 earnings which generated releases on reporting as of. It made no dent in Omeros relentless downward slide. Omeros managed to monetize its troublesome OMIDRIA asset in a 12/2021 deal which provides Omeros significant ongoing revenues.
Since 10/2021 the market has essentially ignored any positive Omeros news. Omeros' share chart turned from sawtooth jagged to just plain ragged following its 10/2021 advice from the FDA that it had found deficiencies in Omeros' narsoplimab BLA for HSCT-TMA. Omeros has run its shareholders through the ringer in recent weeks. In this article, I address this critical question head on with recourse to Omeros latest Q1, 2022 earnings call (the " Call"). Recent comments to my most recent Omeros article, "Omeros: The Weight Of The Wait, A Conundrum" have tended to the apocalyptic as reflected by the recent comment below:Ĭomment to Omeros: The Weight Of The Wait, A Conundrum () Omeros ( NASDAQ: OMER) has been a favorite of mine over the years since my 03/2018 article "Omeros: Beauty And The Beast".
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