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Evofem Biosciences, Inc. (OTCQB: EVFM) is a pioneering biotechnology company dedicated to enhancing women's reproductive health across the globe. The company's flagship product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), is an FDA-approved, hormone-free contraceptive gel. Applied 0-60 minutes before sex, Phexxi maintains the vagina's natural pH, creating an environment unsuitable for sperm. This innovative product has seen increased sales and usage each year since its launch in 2020.
Evofem is committed to providing woman-controlled, non-invasive, and reversible reproductive health solutions. The company's recent strategic initiatives include securing expanded Medicaid coverage in Washington State and renegotiating rebates with Medi-Cal in California. These moves have made Phexxi more accessible to millions of women on state healthcare plans.
In December 2023, Evofem entered a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX). This acquisition is expected to accelerate Evofem's growth and expand its product portfolio. The company anticipates this merger will close in the second half of 2024.
Financially, Evofem continues to show resilience and growth. In 2023, the company reported $18.2 million in net sales and a significant reduction in operating expenses. Despite challenges like a cyberattack and ongoing austerity measures, Evofem expects its fourth consecutive year of sales growth in 2024.
Looking forward, Evofem is poised to benefit from the burgeoning use of GLP-1 receptor agonists, which can reduce the effectiveness of oral contraceptives. As a non-hormonal contraceptive, Phexxi offers a critical alternative for women using these medications. Evofem's innovations and strategic partnerships underscore its commitment to addressing unmet needs in women's health.
Evofem Biosciences (OTC-PINK:EVFM) announced significant cost reduction measures to achieve cash flow break-even by year-end 2023. These measures include a 39% reduction in payroll expenses, with a 40% cut in CEO salary and 20% for other executives. The company will consolidate three sales territories and eliminate eight positions, including the Chief Commercial Officer, effective March 17, 2023. Despite the difficult nature of these cuts, CEO Saundra Pelletier emphasized their necessity for long-term success and continued support for their hormone-free contraceptive product, Phexxi.
Evofem Biosciences (OTC-PINK: EVFM) announced the appointment of Albert Altro as Interim Chief Financial Officer, succeeding Jay File, who is leaving for other opportunities. Mr. Altro brings over 25 years of experience in financial management and corporate restructuring. His expertise is expected to guide the company’s fiscal strategy, aiming to enhance shareholder value.
CEO Saundra Pelletier expressed confidence in Mr. Altro's ability to lead the company’s financial direction. Evofem focuses on women's sexual and reproductive health, with its flagship product being Phexxi, a hormone-free contraceptive.
Evofem Biosciences (OTCQB: EVFM) announced a partnership with SimpleHealth, which will now offer Phexxi®, the first hormone-free vaginal gel approved by the FDA for contraception. This collaboration aims to enhance awareness and accessibility of Phexxi, catering to women seeking non-hormonal birth control options. SimpleHealth delivers a comprehensive service, including contraceptive counseling and online prescriptions, now expanded to include Phexxi. Saundra Pelletier, CEO of Evofem, emphasized the partnership as a strategy to meet women's needs effectively. Phexxi provides a safe, on-demand contraceptive method that can empower women in their reproductive health decisions.
Evofem Biosciences (OTCQB: EVFM) announced the addition of two new patents for Phexxi®, its contraceptive product, to the FDA Orange Book. The newly awarded patents, covering the formulation and its method of use, extend the company's patent portfolio until March 2033. The '989 patent', issued on May 24, 2022, and the '610 patent', issued on September 13, 2022, further strengthen the intellectual property protection for Phexxi. CEO Saundra Pelletier emphasized the importance of expanding their patent estate for future growth opportunities in both U.S. and global markets.
Evofem Biosciences (OTCQB: EVFM) announced a strategic process on Feb. 23, 2023, to evaluate alternatives aimed at maximizing shareholder value. Potential options include mergers, sales of assets, or licensing agreements. The Board of Directors is collaborating with Joseph Gunnar & Co., LLC as their exclusive financial advisor. The company is known for Phexxi, the first FDA-approved hormone-free contraceptive gel targeted at women who prefer non-hormonal birth control due to associated health risks. Evofem highlights a significant market need, noting over 23 million U.S. women do not wish to use hormonal contraception.
Evofem Biosciences announced that Favor, a female telehealth provider, has added its hormone-free contraceptive gel, Phexxi, to its product offerings. Favor aims to provide patients with a non-hormonal option alongside over 120 hormonal contraceptives. The collaboration is expected to enhance retail channel growth in 2023. Favor has prescribed contraception to over three million patients since 2016, addressing the increasing demand for non-hormonal birth control methods. This partnership reflects Evofem's commitment to innovative solutions in women's reproductive health.
Evofem Biosciences, Inc. (EVFM) announced key insurance victories expanding access to its hormone-free contraceptive, Phexxi, for millions. Medicaid coverage improved for over 3.7 million lives across 11 states, with significant changes including:
- Phexxi moved to Preferred status with no restrictions in nine states, benefiting 3 million lives.
- In Mississippi and Indiana, coverage expanded with no prior authorization for over 600,000 and 1.4 million lives, respectively.
Additionally, commercial coverage was enhanced under major payers in Michigan and Pennsylvania, affecting 2.25 million lives.
Evofem Biosciences, Inc. (OTCQB: EVFM) has been granted an extension by the OTC Markets Group to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022. The new deadline for submission is January 6, 2023, extending from the previous date of December 29, 2022. This extension comes as the company continues to navigate its filing obligations amidst ongoing developments in its business, particularly regarding its FDA-approved product, Phexxi.
Evofem Biosciences, Inc. (OTCQB: EVFM) has announced that the Phase 3 EVOGUARD clinical trial for its product EVO100, aimed at preventing chlamydia and gonorrhea infections in women, did not meet its endpoints. Despite a consistent safety profile, the trial's failure has raised concerns, with executives attributing the results partially to COVID-19 impacts on trial conditions. The company will redirect focus toward its FDA-approved product, Phexxi, which has shown strong sales growth and market access expansion. Future investment in the STI program will be discontinued due to financial constraints.
On October 6, 2022, Evofem Biosciences (OTCQB: EVFM) announced its hormone-free contraceptive gel received regulatory approval from Nigeria's NAFDAC. This marks the company's first approval outside the U.S., with plans for additional submissions in Ghana, Ethiopia, and Mexico. The product may be marketed as Femidence™, targeting Nigeria's 45 million women of reproductive age. In October 2020, Adjuvant Capital invested $25 million to support global market access for Phexxi and ongoing clinical trials to evaluate its effectiveness against chlamydia and gonorrhea, with results expected in mid-October 2022.
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