November 11, 2019
On their recent conference call for The Medicines Company (MDCO), management highlighted the power of Inclisiran’s profile and likelihood of its potential to change the paradigm of ASCVD (atherosclerotic cardiovascular disease) treatment, notes biotech expert John McCamant, editor of The Medical Technology Stock Letter.
Although the PCSK9 landscape is improving with lower prices for the antibodies and wider insurance coverage, we agree with MDCO management that the size of the market is many more multiples that prescription/sales currently suggest.
The full data sets of ORION-9 and -10 will be presented at AHA later this month. The long-term cardiovascular outcomes study (ORION-4) continues to enroll patients and is expected to be completed by year-end 2020 at the latest.
In addition, the company reported the validation of commercial scale manufacturing batches of Inclisiran, which will be included in the upcoming regulatory filings.
The NDA submission will be completed this quarter, and the MAA filing will occur in Q1:20. Management currently does not anticipate that the FDA will hold an Advisory Committee meeting to discuss approval of Inclisiran in the US.
The stock has been a little volatile recently as investors’ hope for a strategic transaction takes the main focus away from the value proposition commercialization/pricing of Inclisiran relative to the PCSK9s.
Prescription volumes of the class are growing nicely. Management and the board of directors at MDCO are as experienced and astute as they come. The stock should begin to move higher as people begin to realize how big the cardiovascular market could be for a twice a year LDL lowering vaccine priced at $4K.
In our view, this could easily be a multi-billion drug/vaccine given the safety, efficacy and low price point. We believe the potential takeover value of MDCO is much higher than the current stock price.