- Sales of Sage Therapeutics' new postpartum depression drug Zulresso totaled just $1.5 million in the therapy's first full quarter since winning U.S. approval, confirming expectations that building a market would take time.
- Zulresso, the first drug ever approved by the Food and Drug Administration to treat postpartum depression, is infused over 60 hours and needs to be administered in certified healthcare facilities. Executives said such sites require between six and nine months to prepare for treating new mothers.
- While slow sales for a biotech's first drug might usually be met with disappointment, most Wall Street analysts were unfazed, focusing instead on forthcoming data for an experimental depression drug that investors view as critical for Sage's future growth.
Sage is one of a handful of biotech companies focused exclusively on psychiatric and neurological diseases, a therapeutic field known for its challenging drug development prospects.
Securing FDA approval of Zulresso (brexanolone) was a major milestone for Sage and for women who, until March, had no treatment options designed specifically for their postpartum depression.
For a number of reasons, however, many expected selling the drug to be an even steeper challenge. The drug comes with a black box warning for the risk of sedation and sudden loss of consciousness — side effects that played a role in the FDA's decision to clear the drug with a Risk Evaluation and Mitigation Strategies plan that require it be given in a certified healthcare facility.
Zulresso is also infused over two and half days, time that may be hard to come by for new mothers who don't have someone to look after their child during treatment.
Practically, Zulresso's REMS and other requirements have meant sites need significant time to become treatment-ready. While 140 sites were REMS certified as of Sept. 30, Zulresso was administered in only 11 facilities during the third quarter.
"Our experiences in the field are also confirming that the majority of healthcare sites will take six to nine months to become treatment ready," Sage CEO Jeff Jonas said on a conference call Tuesday.
"Unfortunately, that means many women with postpartum depression have not been able to access treatment with Zulresso during the first three months of the launch."
Executives carefully laid out expectations Tuesday that revenues from Zulresso will remain modest over the "next few quarters," indicating a turning point could come in the second half of next year.
"Given initial treating patterns at sites of care, we believe revenue momentum may lag the expected increase in site of care activation," said Mike Cloonan, Sage's chief business officer, on the call.
That's slightly later than what Sage originally guided to, according to SVB Leerink analyst Marc Goodman, who pointed to the time needed to get sites up to speed.
Analysts, however, are much more focused on an upcoming trial readout for SAGE-217.
That study, called MOUNTAIN, tests the experimental drug in patients with major depressive disorder and is viewed as a key test of the therapy's potential.
Results will show how treatment affects scores on a depression rating scale known as HAM-D after two weeks. Additional data on four weeks of blinded follow-up will also be released, company executives said.
Unlike Zulresso, investors are penciling in a significant market opportunity for SAGE-217.
"Expectations remain very high for SAGE-217 and that the stock already assumes an upcoming positive study as well as several billion in sales for the product," wrote SVB Leerink's Goodman.