We provide here a sensitivity analysis for the upcoming Kuvan PDUFA decision, which is expected this Friday. As Kuvan is an orphan drug with a near-perfect side effect profile, approval is considered to be a near certainty, but how BioMarin Pharmaceuticals (BMRN) will trade will not only depend upon the FDA approval decision, but also on pricing, which the Company will announce upon approval. Estimates for an annual price/patient start at $30,000 and go as high as $50,000+. Another issue, the wording in the label agreed upon with the FDA, will drive uptake, as a restricted label would likely lead to tighter reimbursement and lower patient eligibility.

We analyze all three of these factors (approval/non-approval, pricing, and labelling) in this sensitivity analysis. Please note that this event includes estimates that may appear to be somewhat in conflict with our Kuvan revenue model & BMRN valuation on the site. However, the valuations we provide here are more based on how we believe the market would respond to the differing scenarios than on where we would value the 5-year valuation of BioMarin. For more details on our assumptions on Kuvan and our valuation of BMRN, see our recent valuation update.

For the analysis, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.