Myovant Sciences (MYOV) delivered strong Q1:22 total revenue of $116.5 million, including net product revenue of $41.4 million, reports John McCamant, biotech expert and editor of The Medical Technology Stock Letter.
U.S. sales of the novel oral prostate cancer drug ORGOVYX grew sharply and came in at $36 million, with sequential quarterly growth of 26% and total patients now estimated at 18,000 through June 2022.
Revenue from U.S. sales of MYFEMBREE came in at $4 million in Q1, with sequential quarterly demand volume growth of 54%. The uterine fibroids drug is now the market leader in total prescriptions (TRx) with 51% TRx share as of June 2022.
The drug is poised for significant growth with a potential FDA approval for Endometriosis on or before their upcoming PDUFA date of August 6th. The total revenue beat was driven primarily by a $50 million upfront payment from the Accord licensing deal.
The company has had very positive feedback recently from the regarding FDA labeling which indicates a high probability of endometriosis approval.
In our view, this removes a significant concern following the issuance of a deficiency letter from the FDA on Myovant's endometriosis sNDA earlier this year. Importantly, it seems like these regulatory issues may be resolved as the company indicated on the conference call that it had received labeling comments from the FDA.
Deficiency letters are issued in advance of labeling discussions that specifically state that they preclude discussion of labeling. The approval for the biotech's MYFEMBREE for the treatment of endometriosis on August 6 would trigger an impressive $100 million milestone payment from partner Pfizer (PFE).
The company continues to execute at a high level as they have a true "pipeline in a pill" in regulolix; now approved for both prostate cancer and uterine fibroids, with endometriosis up next. In our view, launch trends remain strong and we believe the company is ripe for a premium buyout and Pfizer (despite passing on EU) remains the number one suitor.