TherapeuticsMD, Inc. TXMD announced that it has entered into an exclusive license and supply agreement with leading, global specialty pharmaceutical company dedicated to women’s health, Theramex. The agreement grants exclusive commercialization rights for hormone therapy drugs, Bijuva and Imvexxy, to Theramex in markets outside the United States, excluding Canada and Israel.
Bijuva, a bio-identical hormone therapy combination of estradiol and progesterone, is approved for treating moderate-to-severe vasomotor symptoms (“VMS”) in post-menopausal women. Imvexxy, a vaginal estradiol softgel, is approved for treating moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy (“VVA”), due to menopause. Both drugs were approved in 2018. While Imvexxy was launched in the U.S. market in July 2018, Bijuva was launched in April 2019.
Per the terms of the agreement, TherapeuticsMD is eligible to receive 14 million euro ($15.8 million) in upfront fees in cash, an aggregate of 2 million euro ($2.3 million) upon approval of the drugs in certain specified markets and up to 27.5 million ($31.1 million) in sales milestone payments based on net sales in licensed territories. The agreement will also help TherapeuticsMD to leverage Theramex’s extensive women’s health capabilities and infrastructure for rapid commercialization of Bijuva and Imvexxy in ex-U.S. markets.
Operating expenses for TherapeuticsMD are on the rise mainly driven by expenses to support the launch of its drugs. The upfront and milestone fee will boost the company’s fund, which will help it to remain on track with its commercialization plans.
We remind investors that Imvexxy has generated sales of almost $3.1 million since its launch. Sales more than doubled sequentially in the first quarter of 2019. However, Bijuva is expected to face stiff competition from Pfizer’s PFE Prempro, AMAG Pharmaceuticals’ AMAG Intrarosa and Allergan’s AGN Estrace. There are several companies marketing generic version of Estrace, which will also compete with Bijuva.
Apart from Bijuva and Imvexxy, TherapeuticsMD also received approval for another hormone therapy drug, Annovera, as the first and only patient-controlled, procedure-free, reversible prescription contraceptive in the United States. The drug is expected to be commercially launched by the first quarter of 2020.
TherapeuticsMD’s shares have declined 17.4% so far this year against the industry’s increase of 5.5%.
TherapeuticsMD currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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