Evofem Expects Significant Reduction in PHEXXI Manufacturing Cost Through Agreement with Windtree Therapeutics
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.
Evofem Biosciences (OTCQB: EVFM) ha stipulato un Accordo di Licenza e Fornitura con Windtree Therapeutics (NasdaqCM: WINT) per ridurre i costi di produzione di PHEXXI, il loro gel vaginale contraccettivo senza ormoni approvato dalla FDA. Si prevede che la partnership riduca i costi di produzione di PHEXXI del 55% al 60% rispetto ai livelli attuali, senza costi di trasferimento tecnologico per Evofem.
PHEXXI, che previene la gravidanza mantenendo livelli normali di pH vaginale sfavorevoli agli spermatozoi, beneficerà dei contatti di produzione di Windtree per ottenere costi di produzione più bassi. Questa riduzione dei costi mira a facilitare l'espansione globale di PHEXXI in mercati sensibili ai prezzi dove i contraccettivi non ormonali sono richiesti.
Evofem mantiene la proprietà e continua la commercializzazione negli Stati Uniti tramite il proprio team di vendita, mentre persegue l'espansione internazionale attraverso partnership strategiche, inclusa una licenza con Pharma 1 Drug Store per l'ingresso nel mercato degli Emirati Arabi Uniti prevista per luglio 2024.
Evofem Biosciences (OTCQB: EVFM) ha firmado un Acuerdo de Licencia y Suministro con Windtree Therapeutics (NasdaqCM: WINT) para reducir los costos de fabricación de PHEXXI, su gel vaginal anticonceptivo sin hormonas aprobado por la FDA. Se espera que la asociación reduzca los costos de fabricación de PHEXXI en un 55% a 60% desde los niveles actuales, sin costos de transferencia de tecnología para Evofem.
PHEXXI, que previene el embarazo al mantener niveles normales de pH vaginal que son hostiles para los espermatozoides, se beneficiará de los contactos de fabricación de Windtree para lograr costos de producción más bajos. Esta reducción de costos tiene como objetivo facilitar la expansión global de PHEXXI en mercados sensibles al precio donde hay demanda de anticonceptivos no hormonales.
Evofem mantiene la propiedad y continúa la comercialización en EE.UU. a través de su equipo de ventas, mientras persigue la expansión internacional mediante asociaciones estratégicas, incluida un acuerdo de licencia con Pharma 1 Drug Store para la entrada en el mercado de los EAU prevista para julio de 2024.
에보펨 바이오사이언스 (OTCQB: EVFM)는 윈드트리 테라퓨틱스 (NasdaqCM: WINT)와 라이선스 및 공급 계약을 체결하여 FDA 승인 호르몬 비함유 피임용 질 젤 PHEXXI의 제조 비용을 줄이기로 했습니다. 이 파트너십은 현재 수준에서 PHEXXI의 제조 비용을 55%에서 60%까지 줄일 것으로 예상되며, 에보펨에게는 기술 이전 비용이 발생하지 않습니다.
PHEXXI는 정자의 생존에 부적합한 정상적인 질 pH 수준을 유지하여 임신을 예방하며, 윈드트리의 제조 네트워크를 통해 생산 비용을 낮출 수 있을 것입니다. 이 비용 절감은 비호르몬 피임약에 대한 수요가 있는 가격 민감 시장으로 PHEXXI의 글로벌 확장을 촉진하는 것을 목표로 합니다.
에보펨은 소유권을 유지하며 판매 팀을 통해 미국 내 상업화를 계속하고, 2024년 7월 아랍에미리트 시장 진출을 위한 Pharma 1 약국과의 전략적 파트너십을 통해 국제적 확장을 추구하고 있습니다.
Evofem Biosciences (OTCQB: EVFM) a conclu un Accord de Licence et de Fourniture avec Windtree Therapeutics (NasdaqCM: WINT) afin de réduire les coûts de fabrication de PHEXXI, leur gel vaginal contraceptif sans hormones approuvé par la FDA. Ce partenariat devrait réduire les coûts de fabrication de PHEXXI de 55 % à 60 % par rapport aux niveaux actuels, sans coûts de transfert de technologie pour Evofem.
PHEXXI, qui prévient la grossesse en maintenant des niveaux de pH vaginal normaux peu accueillants pour les spermatozoïdes, bénéficiera des contacts de fabrication de Windtree pour obtenir des coûts de production plus bas. Cette réduction des coûts vise à faciliter l'expansion mondiale de PHEXXI sur des marchés sensibles aux prix où la demande de contraceptifs non hormonaux est forte.
Evofem conserve la propriété et continue la commercialisation aux États-Unis par l'intermédiaire de son équipe de vente, tout en poursuivant son expansion internationale grâce à des partenariats stratégiques, y compris un accord de licence avec Pharma 1 Drug Store pour une entrée sur le marché des Émirats Arabes Unis prévue pour juillet 2024.
Evofem Biosciences (OTCQB: EVFM) hat eine Lizenz- und Liefervereinbarung mit Windtree Therapeutics (NasdaqCM: WINT) abgeschlossen, um die Produktionskosten von PHEXXI, ihrem von der FDA zugelassenen hormonfreien vaginalen Gel, zu senken. Es wird erwartet, dass die Partnerschaft die Produktionskosten von PHEXXI um 55% bis 60% im Vergleich zu den aktuellen Kosten senken wird, ohne dass Evofem Technologietransferkosten entstehen.
PHEXXI, das eine Schwangerschaft verhindert, indem es normale vaginale pH-Werte aufrechterhält, die für Spermien ungünstig sind, wird von Windtrees Produktionskontakten profitieren, um die Produktionskosten zu senken. Diese Kostenreduzierung zielt darauf ab, die globale Expansion von PHEXXI in preissensible Märkte zu erleichtern, in denen eine Nachfrage nach nicht-hormonellen Verhütungsmitteln besteht.
Evofem behält das Eigentum und setzt die Vermarktung in den USA durch sein Vertriebsteam fort, während das Unternehmen internationale Expansionen durch strategische Partnerschaften verfolgt, einschließlich einer Lizenzvereinbarung mit Pharma 1 Drug Store für den Markteintritt in die VAE im Juli 2024.
- 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
- Currently trading on OTCQB market rather than major exchange
Insights
This manufacturing agreement represents a transformative development for Evofem's business model. A
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.
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
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
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
"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
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
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?
What are the financial terms of EVFM's tech transfer agreement with Windtree?
How will the Windtree partnership affect EVFM's global expansion plans?
What international partnerships does EVFM currently have for PHEXXI distribution?
