Bloomberg has this to say last week for products coming up for Pass Through Status Expiration, FWIW. I have not seen the final status of Omridia. But I model little value for this product, and most value for OMS721 and its potential in Kidney diseases especially. Then the sum value of these two agents, and much less for the remaining 'pipeline'. From this value, then, I subtract additional value for distrust and brashness of their CEO, and subtract away more value for its "anecdotal" PRs of single (or limited) patients, wreaking signs of desperation. Not considering debt, I still consider the value of the company greater than $1B, now about $700M. Once the FDA grants SPA agreement for the OMS721-nephropathy ph3 trial, then the overall company value would (could) jump due to product potential in this indication alone.
Disclosure: Long OMER, and cautiously optimistic, FWIW, my original OMER basis is ~$8/sh, and I added some more (perhaps foolishly) last week.
From Bloomberg last week (no link saved in my company notes, sorry)
• The Centers for Medicare & Medicaid Services (CMS) has issued its final update on the therapies facing expiration of pass-through status in 2018.
• Normal Medicare reimbursement is based on past claims, not possible for new products. Pass-through status, which allows payment for new products on a temporary basis, typically runs for two-to-three years to establish claims history. The pass-through price is first determined by the wholesale acquisition cost (WAC) plus 6%, then transitions to average selling price plus 6%.
• Affected products include:
• Omeros (NASDAQ:OMER): Omidria (phenylephrine and ketorolac injection)
• Eli Lilly (NYSE:LLY): Amyvid (florbetapir)
• Astellas (OTCPK:ALPMY)/Merck (NYSE:MRK): Zerbaxa (ceftolozane/tazobactam)
• Allergan (NYSE:AGN): Dalvance (dalbavancin)
• The Medicines Company (NASDAQ:MDCO): Orbactiv (oritavancin)
• Novartis (NYSE:NVS): Signifor (pasireotide)
• J&J (NYSE:JNJ): Sylvant (siltuximab)
• Alimera Sciences (NASDAQ:ALIM): Iluvien (fluocinolone acetonide intravitreal implant)
• Amgen (NASDAQ:AMGN): Blincyto (blinatumomab)
• Bristol-Myers Squibb (NYSE:BMY): Opdivo (nivolumab)
• Merck: Keytruda (pembrolizumab)
Further info, separate from the above Bloomberg article, Summary of current billing for Omidria:
eyeworld.org |
