Medivation bullish on Xtandi as PDUFA approaches
- Medivation reported strong second-quarter sales, led by its blockbuster prostate cancer drug, Xtandi (enzalutamide), which generated $595 million in revenues, up 9% from the year-prior period. (Medivation co-markets Xtandi with Astellas).
- During an investor call, CEO David Hung focused on Xtandi's potential for continued growth based on anticipated label updates from the TERRAIN and STRIVE trials later this year, increased diagnosis of metastatic prostate cancer and Xtandi sales outpacing competition.
- Hung confirmed Medivations's continued pursuit of gaining approval of Xtandi for use in treatment of breast cancer.
During Medivation's second quarter earnings call with investors, Hung provided numerous details about the factors impacting Xtandi's rising share of prostate cancer market. In contrast, he was stone silent on the topic of a potential acquisition of the company by Sanofi, or any other company.
Xtandi continues to be the star of Medivation's portfolio, with some analysts predicting close to $3 billion in annual revenues by 2018. Hung's comments reflected that optimism as he laid out the competitive landscape, highlighting Xtandi's growing advantage over Zytiga in the market.
"We expect that gap to continue to widen as Xtandi's efficacy, safety and convenience profile is increasingly preferred over abiraterone by both prescribers and patients, particularly given a very recent development in abiraterone's label," he said during the call.
"Just over two months ago, the abiraterone label was updated to reflect new, hepatotoxicity issues based upon abiraterone's post-marketing experience."
Hung's comments also suggested that the company has a very good chance of seeing the Food and Drug Administration approve its supplemental application to include data from two Phase 3 studies—TERRAIN and STRIVE—in its label. The FDA is expected to make a decision on the label update by October 22.
That data highlights Xtandi's efficacy in treatment of prostate cancer patients with non-metastatic disease in the TERRAIN study, and the significant improvement in progression-free survival in Xtandi-treated patients versus patients treated with bicalutamide, a frequently used treatment in prostate cancer.
All of the detail about Xtandi notwithstanding, Hung's silence on the topic of a potential acquisition by Sanofi was glaringly obvious, but not unexpected. Last month, Medivation entered takeover talks with Sanofi after rejecting a previous $9.3 billion bid.
"This wasn't a terribly meaningful earnings call in terms of newsflow, since management (understandably) did not comment on the topic everyone wanted to hear about: the ongoing M&A discussions with Sanofi and other biopharma players that have signed CDAs with Medivation," wrote RBC Capital Markets analysts Simos Simeonidis in a recent note.
"Aside from that topic, and despite not commenting on its interactions with FDA, management appeared optimistic on the outcome of the 10/22/16 PDUFA for Xtandi's label expansion."
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