Evofem Biosciences Inc (OTCMKTS: EVFM) is a San Diego-based commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs). The Company’s first commercial product, Phexxi, was approved by the FDA on May 22, 2020, and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. Evofem commercially launched Phexxi in September 2020 in the United States and intends to commercialize Phexxi in all other global markets through partnerships or licensing agreements. Evofem is also evaluating Phexxi for two potential new indications: the prevention of chlamydia and the prevention of gonorrhea in women. These are two of the most pervasive STIs in the United States. 

Phexxi is the first and only FDA-approved hormone-free, woman-controlled contraceptive gel that women use on demand.  Because Phexxi is a non-hormonal birth control method, it is not associated with common side effects like depression, weight gain, headaches, mood swings, irritability, and reduced libido. Taking hormones may not be right for some women, especially those with certain medical conditions including clotting disorders, cancer, a BMI over 30, and diabetes; women who are breast feeding; and women who smoke. More than 23 million women in the U.S. do not want to get pregnant and will not use hormonal contraception, so the unmet need for an innovation like Phexxi is significant.   

The Company recently expanded access to Phexxi for millions of women across the country with 3 recent Medicaid wins that move Phexxi to a Preferred formulary position with no restrictions, improving Phexxi coverage for more than 3.7 million lives in 11 states. A leading Managed Medicaid provider removed the Prior Authorization (PA) and moved Phexxi from Non-Preferred to Preferred for 14 of its Managed Medicaid plans effective November 2, 2022. This change improved Phexxi coverage for approximately 3 million lives in nine states: Georgia, New York, New Jersey, Virginia, Maryland, Indiana, Nevada, Nebraska and Florida. in Mississippi, Medicaid removed the PA and moved Phexxi from Non-preferred to Preferred Agent effective January 1, 2023 and in Indiana Phexxi was added to the State Medicaid Preferred Drug List with no PA effective January 1, 2023.   

Evofem also expanded its commercial coverage for Phexxi with wins including a marquis university health plan in Pennsylvania and the largest commercial payer in Michigan (effective January 1, 2023). These payers serve over 2.25 million lives in aggregate. Both payers have removed the PA and moved Phexxi to Preferred formulary status; Phexxi’s new position is $0 Preferred with no restrictions.  

$EVFM raised $400M.
It's $0.05 now. https://t.co/Spk9cwFYf7

— Denver Hodge Lentil Fund (@DerAchsenZeit) February 27, 2023

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Earlier in 2022, Evofem opened avenues for Phexxi with payers including one of the nation’s largest Pharmacy Benefit Managers (PBMs); a highly respected national-level commercial payer that added Phexxi to formulary for standard plans nationwide; large payers in California and Hawaii, both with no copay for Phexxi patients; and one of the largest payers in Utah, with no prior authorization. Under section 2713 of the Public Health Service (PHS) Act, group health plans and health insurers are required to cover preventive care and screenings under guidelines issued by the Health Resources and Services Administration (HRSA 

Last week Evofem said its Board of Directors has unanimously approved a comprehensive strategic process to explore and evaluate strategic alternatives to maximize shareholder value. Potential strategic alternatives to be explored or evaluated as part of this process may include a merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company.  

On February 27 EVFM annnounced two additional U.S. patents which cover Phexxi® (lactic acid, citric acid and potassium bitartrate) and its labeled indication are now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The newly listed U.S. Patent No. 11,337,989 (the ‘989 patent) covers contraception using the L-Lactic Acid Phexxi formulation. The ‘989 patent was issued by the U.S. Patent and Trademark Office (USPTO) on May 24, 2022 and is expected to expire in March 2033.  The newly listed U.S. Patent No. 11,439,610 (the ‘610 patent) covers compositions containing L-Lactic Acid, including the Phexxi formulation. The ‘610 patent was issued by the USPTO on September 13, 2022 and is expected to expire in March 2033.  

CEO Saundra Pelletier stated: “The Orange Book listing of these two patents covering Phexxi’s composition of matter and its method of use in contraception is an important step in further strengthening our patent portfolio. We plan to further expand our intellectual property estate in the U.S. and overseas as we continue to iterate our vaginal pH modulator platform and seek entry into global markets.” 

Evofem Biosciences to Explore Strategic Alternatives to Maximize Shareholder Value $EVFM https://t.co/91yrRWMSxo pic.twitter.com/WW1HZmNFRi

— Evofem Biosciences (@Evofem) February 23, 2023

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Currently trading at a $5.5 million market valuation EVFM os is 159,598,285 with 81,062,148 shars in the public float. Fully reporting OTCQB EVFM is ex Nasdaq and was a high-flying biotech startup at one point on the big boards. The Company still operates its books like a big board and has $42 million in assets and did $16.6 million in revenues for the 9 months ended September 30, 2022 up from just $4 million for the same period in 2021. EVFM has significant investors following as well as built in liquidity and will find a lot of buyers once it reverses. We will be updating on EVFM when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in EVFM either long or short and we have not been compensated for this article.