Evofem Expects Significant Reduction in PHEXXI Manufacturing Cost Through Agreement with Windtree Therapeutics

Rhea-AI Summary

Evofem Biosciences (OTCQB: EVFM) has entered into a License and Supply Agreement with Windtree Therapeutics (NasdaqCM: WINT) to reduce manufacturing costs of PHEXXI, their FDA-approved hormone-free contraceptive vaginal gel. The partnership is expected to decrease PHEXXI's manufacturing costs by 55% to 60% from current levels, with no tech transfer costs to Evofem.

PHEXXI, which prevents pregnancy by maintaining normal vaginal pH levels inhospitable to sperm, will benefit from Windtree's manufacturing contacts to achieve lower production costs. This cost reduction aims to facilitate PHEXXI's global expansion into price-sensitive markets where non-hormonal contraceptives are in demand.

Evofem maintains ownership and continues U.S. commercialization through its sales team, while pursuing international expansion through strategic partnerships, including a July 2024 license agreement with Pharma 1 Drug Store for UAE market entry.

Positive

• Manufacturing costs reduction of 55-60% for PHEXXI
• No tech transfer costs for new manufacturing agreement
• Potential expansion into new global markets
• Existing UAE distribution agreement in place

Negative

• Currently trading on OTCQB market rather than major exchange

Insights

Financial Analyst

This manufacturing agreement represents a transformative development for Evofem's business model. A 55-60% reduction in PHEXXI's manufacturing costs directly addresses a critical barrier to the company's global expansion strategy and could significantly improve gross margins.

For context, this scale of COGS reduction is extraordinary in pharmaceutical manufacturing and could fundamentally alter Evofem's unit economics. With Evofem's micro-cap status, this improvement isn't merely incremental – it's potentially existential. The agreement structure is particularly favorable as Evofem avoids technology transfer costs while maintaining full ownership and commercialization rights.

The timing aligns with Evofem's recent UAE licensing agreement, suggesting an accelerating international strategy. By solving the manufacturing cost equation, previously unprofitable markets suddenly become viable opportunities. This creates a clear pathway to scale beyond the U.S. market, particularly in price-sensitive regions.

This cost restructuring addresses a fundamental business challenge that was likely hampering investor confidence. While execution risks remain regarding implementation of the new manufacturing process, the magnitude of potential savings provides substantial breathing room for a company operating with capital resources.

Supply Chain Expert

This partnership represents an elegant solution to Evofem's manufacturing challenges. Rather than traditional contract manufacturing, Evofem is leveraging Windtree's supplier network and expertise to dramatically reduce production costs while maintaining product quality.

The 55-60% cost reduction suggests Evofem's previous manufacturing approach was fundamentally inefficient. Pharmaceutical production typically sees incremental improvements of 5-15% through optimization; this level of reduction indicates a complete manufacturing paradigm shift.

What's particularly noteworthy is the zero-cost technology transfer. This process typically represents a significant expense and risk point when changing manufacturers. By eliminating this burden, Evofem preserves capital while accelerating implementation timelines.

The agreement maintains Evofem's quality standards with validation batches meeting FDA requirements – critical for a regulated pharmaceutical product. This structure allows Evofem to remain focused on commercialization and market expansion while outsourcing manufacturing optimization to a partner with specialized expertise.

This approach effectively removes the manufacturing cost barrier that prevented global market penetration, potentially unlocking significant value from existing intellectual property without additional R&D investment.

-- Evofem's Cost to Manufacture PHEXXI will Decrease by 55% - 60% --

SAN DIEGO, March 26, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem or the Company) today announced that it has entered into a License and Supply Agreement (L&S Agreement) with Windtree Therapeutics, Inc. (NasdaqCM: WINT), under which Windtree will be Evofem's sourcing partner for PHEXXI® (lactic acid, citric acid and potassium bitartrate). This FDA-approved hormone-free contraceptive vaginal gel is applied 0 to 60 minutes before each act of intercourse. It prevents pregnancy by maintaining the normal vaginal biome which has a slightly acidic pH that is inhospitable to sperm.

Under the L&S Agreement, Windtree will leverage its manufacturing contacts to reduce the cost to manufacture PHEXXI. Evofem expects PHEXXI COGS will decrease by 55% to 60% from current levels. Furthermore, there will be no cost to Evofem for the tech transfer to the new manufacturer engaged by Windtree.  

"Global expansion of PHEXXI has always been a critical mandate for Evofem, but a significant hurdle has been high manufacturing costs which make commercialization cost-prohibitive in many markets outside of the U.S.," said Saundra Pelletier, CEO of Evofem. "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. Our goal is to empower women; to have PHEXXI available in all markets around the world is a big step in that direction."

Jed Latkin, CEO of Windtree, noted, "Using our extensive contacts across the globe, we have engaged with a pharmaceutical manufacturer on the plan to produce PHEXXI at a far lower cost while delivering the same high quality product that women and their healthcare providers rely on for hormone-free contraception. We look forward to collaborating with Evofem and our manufacturing partner as we do the tech transfer and manufacture the initial batches and validation batches in line with the FDA requirements."

Evofem maintains ownership of the asset and continues to commercialize PHEXXI in the United States through its dedicated sales team and internationally through strategic partnerships, including its July 2024 license agreement with Emirati pharmaceutical company Pharma 1 Drug Store, which plans to launch the hormone-free contraceptive vaginal gel in the UAE following approval by the Emirates Drug Establishment.

About Evofem Biosciences

Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, PHEXXI^® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.

In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. 

PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.

Forward-Looking Statements

This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 24, 2025, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Contact
Amy Raskopf, Chief Business Development Officer
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775

 

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SOURCE Evofem Biosciences, Inc.

FAQ

How much will PHEXXI manufacturing costs decrease through the Windtree Therapeutics agreement?

Manufacturing costs for PHEXXI will decrease by 55% to 60% from current levels through the agreement with Windtree Therapeutics.

What are the financial terms of EVFM's tech transfer agreement with Windtree?

There will be no cost to Evofem for the tech transfer to the new manufacturer engaged by Windtree.

How will the Windtree partnership affect EVFM's global expansion plans?

The reduced manufacturing costs will enable Evofem to enter new, price-sensitive global markets where non-hormonal contraceptives are in demand.

What international partnerships does EVFM currently have for PHEXXI distribution?

Evofem has a July 2024 license agreement with Pharma 1 Drug Store for PHEXXI distribution in the UAE, pending approval by the Emirates Drug Establishment.