Evofem Bioscienc Stock Price, News & Analysis

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.

Evofem Biosciences (OTCQB: EVFM) has upgraded its trading status to the OTCQB Venture Market from the OTC Pink Open Market, retaining its ticker symbol. The company's product, Phexxi®, a hormone-free contraceptive vaginal gel, has seen increasing net sales for three consecutive quarters. The upcoming third-quarter results are expected to continue this upward trend. Scheduled for mid-October 2022, the Phase 3 clinical trial data on Phexxi's effectiveness against chlamydia and gonorrhea could lead to regulatory submissions in 2023, marking a significant step in women's health.

Evofem Biosciences announced the issuance of U.S. Patent No. 11,439,610 covering Phexxi, its hormone-free contraceptive gel. This patent, expected to protect Phexxi until at least 2033, enhances the company's intellectual property portfolio, which includes over 40 patents. Since its launch in 2020, Phexxi has been prescribed to over 100,000 women. Top-line data from the Phase 3 EVOGUARD trial, evaluating Phexxi for preventing chlamydia and gonorrhea, is anticipated in mid-October 2022, with potential regulatory submissions in 2023.