Analysts expect this pharma to grow at more than 100% over the next five years.
Ionis Pharmaceuticals, Inc. (IONS)
From The Medical Technology Stock Letter
Ionis Pharmaceuticals, Inc. (IONS) recently reported its Q4:17 results with strong Spinraza sales and also provided pipeline updates. The $52 million of Q4 Spinraza royalties translates into ~14% of the $363 million in sales reported by Biogen. Spinraza beat the consensus of $328 million and was driven by ex-US growth.
2018 is an important year for the company with two potential approvals and multiple data readouts expected. IONS has started its commercial launch preparations for both inotersen and volanesorsen. We continue to see potential for substantial value creation from the company’s platform.
IONS has a priority review and a PDUFA date of July 6 for inotersen. The company is already preparing for the launch as they have recently said that an FDA AdCom will be unlikely. Thus, IONS will be ready to launch even sooner than July as the approval could come before then. Importantly, IONS management confirmed on the call that they have not seen any cases of severe platelet declines in the inotersen treated patients nor do they see a need to adjust dose based on patient weight as is proposed with volanesorsen. On the call, the company noted that the US sales team is already out in the field and the build-out of the medical affairs team is largely complete. This progress has ‘raised the bar’ in terms of what potential partners must bring to the table and the list is narrowing with the potential for a partnership shortly.
Preparation for the volanesorsen global launch continue as IONS aims for a mid-2018 commercialization. Marketing applications are now accepted in the US, EU and Canada. Yesterday, Akcea reported a new case of Grade 4 thrombocytopenia in the EAP for volanesorsen, and while we are encouraged that the platelet monitoring protocols identified this patient, we will be listening for panel’s comments on these AEs during the AdCom on May 10 ahead of PDUFA date for volanesorsen in FCS set for August 30. Akcea is proposing less frequent dosing of volanesorsen for patients with low body weight and every other week monitoring post-approval (we believe monitoring in the EAP is weekly), and we expect this to be a clear focus at the panel.
IONS continues to execute at a high level and is poised for two significant approvals in 2018. The approvals have the potential to serve as stock catalysts as they would demonstrate the broad potential and further de-risk the deep and progressing IONS pipeline. Next up for IONS is the full results from their Phase I/II Huntingtin’s program with Roche that will be presented this Friday.
IONS is a BUY under 55 with a TARGET PRICE of 70.
John McCamant, The Medical Technology Stock Letter, www.bioinvest.com, March 2018