SeaGen's Tivdak analyst view.Looks like pricing is lower than earlier post says ($70-90k net/year) not $400,000. Keytruda moving down to 1L in cervical, if effective, may reduce the patient pop for 2L some, or at least delay it longer.
Roughly a $500-350mil annual revenue stream and it added 6% to SeaGen market cap today (or $1.7bil ) and roughly 4% to Genmab (their partner, or $1.5bil). I don't know the ownership split, but that's $3bil between the two of them for a $500-350mil annual revenue oncology drug. Seems rich to me, but you could say some of today's move is bounceback from yesterday.
Key takeaways: SGEN announced accelerated approval of Tivdak (tisotumab vedotin), with a label for 2L+ recurrent or metastatic cervical cancer (r/mCC). The approval was largely expected, although the black box warning for ocular toxicities and requirement of eye monitoring was slightly surprising, given the relatively low Gr3+ event rate (4%, vs 45% keratopathy for Blenrep). Additional color from the call included: 1) Tivdak's WAC price was expected to be $90-120K per yr or $70-90K net price (vs. our prior estimate $90k); 2) supporting measures would be implemented to facilitate eye exams required for each dose; 3) Keytruda potentially moving to 1L may change the future development plan.
FDA label included 2L+ r/mCC; black box warning on ocular toxicity. According to mgmt, risk of loss of vision was well characterized and proved to be manageable in the clinical trials with proper prophylaxis. Based on the label, pts were required to have eye examined prior to each dose and take multiple premedication. Although the exact workflow in practice remained unclear, SGEN's commercial team would implement supporting measures to facilitate coordination between the oncologists and the ophthalmologists and mitigate the potential impact on adoption.
Additional color on launch preparation and shifting competitive landscape. Launch preparation had been ongoing for several months, promoting physician awareness and driving payer engagement. With an attractive value proposition in the 2L+ setting, mgmt expected easy reimbursement. Tivdak commercial products were ready for shipment in the next day. While Tivadak currently competed with Keytruda in the 2L setting, the situation may change substantially with Keytruda likely moving to 1L based on recent data from KEYNOTE-826 (See ESMO 2021 Takeaways – Weekend, 09/21/2021).