Windtree Therapeutics Partners with Evofem to Manufacture FDA-Approved Contraceptive PHEXXI
Key Insights
Windtree Therapeutics has entered into a License and Supply Agreement with Evofem Biosciences to become the sourcing partner for PHEXXI, a hormone-free contraceptive vaginal gel that generated over $19 million in annual revenue in 2024.
The partnership aims to significantly reduce manufacturing costs for PHEXXI, potentially enabling Evofem to expand into new price-sensitive global markets where non-hormonal contraceptives are in high demand.
This agreement represents the first step in Windtree's recently announced corporate strategy to transform into a revenue-generating biotechnology company while continuing development of its therapeutic pipeline.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) has secured a strategic License and Supply Agreement with Evofem Biosciences, Inc. (OTCQB: EVFM) to become the sourcing partner for PHEXXI, Evofem's FDA-approved contraceptive product. The announcement, made on March 20, 2025, marks a significant step in Windtree's recently unveiled corporate strategy to become a revenue-generating biotechnology company.
PHEXXI (lactic acid, citric acid, and potassium bitartrate) is a first-in-class, hormone-free, on-demand prescription contraceptive vaginal gel. The product has demonstrated substantial market traction, with annual revenues exceeding $19 million and more than 96,000 boxes of 12 pre-filled applicators sold throughout 2024.
Manufacturing Cost Reduction Strategy
Under the terms of the agreement, Windtree will leverage its extensive manufacturing contacts to produce PHEXXI at significantly reduced costs. While Evofem will maintain ownership of the asset and continue to commercialize the product in the United States and internationally, Windtree aims to generate profitable revenue by contracting with manufacturers capable of producing PHEXXI at costs substantially below current levels.
"This License and Supply Agreement with Evofem is a first step in our plan to generate profitable revenue to provide value to our stockholders," said Jed Latkin, CEO of Windtree. "Using our extensive contacts across the globe, we have engaged with a pharmaceutical manufacturer on the plan to produce PHEXXI."
Latkin added that the company anticipates working closely with its manufacturing partner through the technology transfer process and production of initial and validation batches in accordance with FDA requirements.
Global Market Expansion Potential
For Evofem, the partnership addresses a critical barrier to international expansion. According to Saundra Pelletier, CEO of Evofem, high manufacturing costs have made commercialization cost-prohibitive in many markets outside the United States.
"The meaningful decrease in the per-box cost of PHEXXI that we expect to achieve with Windtree's assistance should allow Evofem to take PHEXXI into new, price-sensitive global markets where there is great need for non-hormonal contraceptives that women control," Pelletier explained. "Our goal is to empower women; and to have PHEXXI available in all markets around the world is a big step in that direction."
It's worth noting that Pelletier serves as President and Chief Executive Officer of Evofem, Interim Chair of Evofem's board of directors, and also holds a position on Windtree's board of directors, creating a natural alignment between the two companies.
Windtree's Evolving Business Model
This agreement aligns with Windtree's January 2025 announcement of a strategic pivot toward becoming a revenue-generating biotechnology company. While pursuing this new business direction, Windtree continues to advance its portfolio of therapeutic candidates, which includes:
- Istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock
- Preclinical SERCA2a activators for heart failure
- Preclinical precision aPKCi inhibitors being developed for potential applications in rare and broad oncology indications
The company is employing a dual approach: generating revenue through strategic partnerships while continuing to develop innovative therapies for critical conditions and diseases.
Market Implications
For Windtree, this agreement represents a potential turning point in its business model, providing a pathway to revenue generation while maintaining its focus on therapeutic development. For Evofem, the partnership could enable significant global market expansion for PHEXXI, particularly in regions where affordable non-hormonal contraceptive options are limited.
The collaboration highlights an emerging trend in the biotechnology sector, where companies are increasingly seeking creative partnerships to maximize the value of approved products while continuing to invest in research and development pipelines.
As the companies move forward with implementation, the success of this partnership could serve as a model for similar arrangements in the industry, particularly for small biotechnology companies looking to optimize manufacturing costs and expand market reach for specialized pharmaceutical products.