Evofem Biosciences commercializes FDA-approved sexual and reproductive health products for women’s health. Its product portfolio includes PHEXX® (lactic acid, citric acid and potassium bitartrate), a hormone-free contraceptive vaginal gel, and SOLOSEC® (secnidazole) 2g oral granules, an oral antibiotic for bacterial vaginosis and trichomoniasis.
Company news commonly covers product sales, operating results, commercialization partnerships, distribution agreements and international regulatory activity for PHEXX and SOLOSEC. Updates also include manufacturing and supply arrangements, stockholder votes, capital-market actions and education or advocacy initiatives tied to women’s health communication.
Evofem Biosciences, Inc. (OTCPK: EVFM) announced a significant insurance victory, expanding access to its hormone-free contraceptive, Phexxi, to millions of women across the U.S. This new inclusion by a major national payer adds nearly four million covered lives. The approval rate for Phexxi claims reached over 72% in July 2022. The company continues its efforts to ensure compliance with recent federal guidelines mandating contraceptive coverage at no cost to patients. Evofem is also poised to report pivotal trial data in October 2022 for new indications of Phexxi.
Evofem Biosciences announced on September 16, 2022, a successful debt restructuring, securing forbearance from debtholders regarding existing defaults. This arrangement alleviates pressure from a previous Nasdaq delisting and emphasizes the importance of its contraceptive product, Phexxi. Key aspects include junior unsecured debt holders converting their obligations into stock rights and a healthcare investor accepting payment-in-kind for future interest. Positive clinical trial results expected next month could enhance strategic discussions and regulatory submissions for Phexxi's expanded use.
Evofem Biosciences (EVFM) will conduct an investor call on Thursday, August 11, 2022, at 5:00 p.m. ET. The call will focus on the company's developments in women's sexual and reproductive health, particularly regarding their FDA-approved product, Phexxi®. Phexxi is a hormone-free vaginal gel contraceptive. The company anticipates releasing top-line data in October 2022 from its Phase 3 EVOGUARD clinical trial, which studies Phexxi for preventing chlamydia and gonorrhea. Details for joining the call are available in the press release.
Evofem Biosciences (Nasdaq: EVFM) reported a strong second quarter of 2022, with Phexxi net product sales rising 42% quarter-over-quarter to $6.0 million. Operating expenses decreased by 8% to $30.5 million, which improved the loss from operations by 16% to $24.4 million. The company completed a Phase 3 trial for Phexxi to prevent chlamydia and gonorrhea, with top-line data expected in October 2022. Evofem maintains its 2022 guidance with expected net sales of $30 to $35 million, reflecting significant growth potential.
Evofem Biosciences, Inc. (Nasdaq: EVFM) announced the appointment of Jenny Yip, a Managing Partner at Adjuvant Capital, to its Board of Directors, expanding the board from five to six independent directors. Yip brings extensive experience in venture capital and women's health investments. Her appointment follows Adjuvant Capital's significant $25 million investment to support Evofem's Phase 3 clinical trial for Phexxi, a hormone-free contraceptive. The firm aims to increase access to Phexxi and explore new indications for women's health worldwide.
Evofem Biosciences (Nasdaq: EVFM) announced the completion of the last subject's visit in its Phase 3 trial, EVOGUARD, for evaluating Phexxi as a preventive measure against chlamydia and gonorrhea in women. Top-line data is expected by October 2022, with a U.S. regulatory submission planned for the first half of 2023. If approved, Phexxi may become the first woman-controlled prophylactic against these STIs, complementing its current indication for pregnancy prevention. The FDA has granted Fast Track and Qualified Infectious Disease Product designations for the product.
Evofem Biosciences (Nasdaq: EVFM) praises the U.S. Department of Health and Human Services and other agencies for confirming that contraceptives must be covered without cost under the Affordable Care Act. CEO Saundra Pelletier emphasized the importance of this guidance in protecting access to contraception. The company plans to engage with insurers and pharmacy benefit managers to ensure compliance regarding its contraceptive product, Phexxi. Additionally, Evofem anticipates releasing results from its Phase 3 clinical trial evaluating Phexxi for preventing chlamydia and gonorrhea in women this fall.
Evofem Biosciences (Nasdaq: EVFM) will host a conference call on August 4, 2022, at 5:00 p.m. ET to discuss its second-quarter financial results and business highlights. Investors can join the call by dialing (800) 285-6670 for U.S. participants or (713) 481-1320 for international participants. The call will also be available via a live webcast at evofeminvestorroom.com. The company specializes in women's sexual and reproductive health, with Phexxi® as its first FDA-approved product, expected to report clinical trial data this fall.
Evofem Biosciences (Nasdaq: EVFM) has announced that its direct-to-consumer (DTC) campaign, House Rules, has won 12 healthcare and communications awards and is nominated for four more. The campaign, featuring Emmy-winning actress Annie Murphy, aims to raise awareness of Phexxi, a hormone-free contraceptive. To date, House Rules has increased brand awareness by 45%, reached 42 million video views, and resulted in over 33,000 telehealth exits. The campaign emphasizes women's choice in birth control, aligning with Evofem's mission to enhance women's reproductive health.
Evofem Biosciences, Inc. (Nasdaq: EVFM) announced a new educational birth control chart aimed at enhancing contraceptive counseling for healthcare providers in the U.S. This chart introduces twelve contraceptive methods, including the vaginal pH modulator, replacing outdated materials. The initiative reflects recent legal changes and aims to empower women in making informed decisions regarding contraception. Evofem's first product, Phexxi®, is a hormone-free contraceptive gel, with expectations to report Phase 3 clinical trial data for new indications in the fall.