TherapeuticsMD, Inc. Looking At Lower Cash Burn, Higher Upside From Promising HRT Therapies: Cowen

November 7, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

TherapeuticsMD, Inc. is likely facing a few quarters of significantly lower cash burn as it finishes enrollment in its two key programs, TX-001HR and TX-004HR for vasomotor symptoms and VVA, respectively, said Boris Peaker, biotech analyst for Cowen and Co., on Friday.

Peaker wrote in a note to investors that with both trials due to complete enrollment in the first half of 2015, “cash burn is expected to dramatically decrease” in the second half of 2015 and beyond. Both are advancing on schedule, with the first data points to be released in in the third quarter of 2015 for VVA.

Enrollment in the 1,750 patient REPLENISH trial (TX-001HR for vasomotor symptoms) is ongoing with anticipated enrollment completion by early 2015 and topline data release in the third quarter of 2015. TX-004 Phase III study in 700 subjects with VVA has begun enrollment after receiving positive feedback from the FDA. A CRO with previous experience in developing female hormone products has been engaged.

“With the lessons learned since the WHI study a decade ago, physicians and patients alike are more comfortable with hormone therapy to alleviate symptoms of menopause. Additionally, The Drug Quality and Security Act passed by both the House and Senate puts pressure on compounding pharmacies and created a vacancy for an FDA approved combination HRT,” said Peaker.

“Although the label, if approved, won't explicitly distinguish TXMD's product vis-avis existing synthetic hormones, we believe that being first to market is a significant competitive advantage and TherapeuticsMD is likely to benefit by converting women currently seeking compounded HRT,” he wrote. “NAMS confirmed that approximately 1 to 2.5 million patients are currently receiving compounded hormone treatment.”

Peaker said analysts remained nonplussed that the company continues to refine its protocol for the Phase 3 study of TX-002HR for secondary amenorrhea.

“We attribute no value to this program as we believe that the commercial opportunity is quite small compared to the company's leading indication,” he said. “We hope that the company does not spend significant capital on this indication.”