Evofem Bioscienc Stock Price, News & Analysis

Evofem Biosciences, Inc. (NASDAQ: EVFM) will host a webcast and conference call on March 3, 2022, at 4:30 p.m. ET to discuss its financial results and business highlights for Q4 and the year ended December 31, 2021. Interested parties can access the live and archived webcast through the company's investor room. The conference call can be joined via phone, with a replay available for 24 hours post-call. Evofem is focused on developing innovative women's sexual and reproductive health products, including the FDA-approved contraceptive gel, Phexxi®.

Evofem Biosciences (NASDAQ: EVFM) announced FDA's "Qualified Infectious Disease Product" (QIDP) designation for EVO100, aimed at preventing urogenital chlamydia in women, marking a potential new indication in clinical development. The company is preparing for top-line data from the Phase 3 EVOGUARD trial in Q3 2022, with positive results likely supporting FDA submission early in 2023. The QIDP designation grants five additional years of marketing exclusivity upon approval, catering to the significant unmet need for STI prevention as no FDA-approved products currently exist.

Evofem Biosciences (NASDAQ: EVFM) will present at the Aegis Virtual Conference on February 23, 2022, at 4:30 p.m. ET. The webcast can be accessed via this link or on Zoom. Evofem is known for its innovative products in women's sexual and reproductive health, including Phexxi®, a hormone-free contraceptive vaginal gel. Phexxi® aims to address unmet needs in contraception and protection against STIs.

Evofem Biosciences (NASDAQ: EVFM) reported strong preliminary results for Q4 2021, achieving $3.5 million in net product sales, more than double Q3 sales. Key metrics included an 81% increase in dispensed Phexxi boxes and a 69% rise in total prescriptions filled. The company also reduced its net cash burn from $32 million in Q3 to approximately $17 million. Additionally, Evofem raised $5 million in non-dilutive capital in January 2022 to support ongoing initiatives. The CEO highlighted strong demand for Phexxi, projecting positive impacts from recently issued government guidance.

Evofem Biosciences (NASDAQ: EVFM) applauds recent guidance from HRSA and the U.S. Department of Labor, mandating coverage for FDA-approved contraceptives, including its product Phexxi, with no out-of-pocket costs for women. This guidance aims to enhance access to contraceptives under the Affordable Care Act, potentially benefiting millions of women. CEO Saundra Pelletier emphasized the positive impact on reducing unintended pregnancies and improving women's access to hormone-free birth control. The comprehensive coverage includes all FDA-approved contraceptives deemed medically necessary by healthcare providers.

Evofem Biosciences (NASDAQ: EVFM) announced its participation in the H.C. Wainwright BioConnect Virtual Conference from January 10–13, 2022. CEO Saundra Pelletier will present updates on the company's hormone-free contraceptive Phexxi® and its pipeline, including an ongoing Phase 3 clinical trial for EVO100 targeting chlamydia and gonorrhea, as well as a new Multipurpose Prevention Technology candidate for HIV. The presentation will be available on-demand starting 7:00 AM ET on January 10.

Evofem Biosciences (NASDAQ: EVFM) and Orion Biotechnology have announced a collaboration to evaluate the compatibility of Orion's CCR5 antagonist, OB-002, with Evofem's Phexxi vaginal gel. This partnership aims to develop a Multipurpose Prevention Technology (MPT) product for HIV prevention in women. The collaboration seeks results by Q3 2022 and will pursue funding for clinical trials if successful. WHO reports show a significant global need for effective HIV prevention methods. Phexxi, launched in September 2020, is a hormone-free contraceptive gel with ongoing trials for STI prevention.

Evofem Biosciences (NASDAQ: EVFM) announced optimistic projections for Q4 2021, expecting prescription growth for Phexxi to exceed 30,000 monthly, marking a 70% increase from Q3. The company anticipates that over 57,000 women will have chosen Phexxi by year-end 2021, with almost 24,000 in Q4 alone. Gross revenues are projected to rise by more than 50% from Q3. CEO Saundra Pelletier also noted a significant reduction in quarterly net cash burn by at least $10 million, highlighting a strong demand for non-hormonal birth control options.

Evofem Biosciences (NASDAQ: EVFM) announced the adjournment of its 2021 Special Meeting of stockholders, originally scheduled for December 8, 2021, to December 15, 2021. The meeting will be held at the company's corporate offices in San Diego, California. Stockholders of record as of November 5, 2021, are eligible to vote. There are no changes to the proposal previously outlined in the proxy statement filed with the SEC on November 9, 2021. The company continues to solicit proxies, and previously submitted proxies will be honored at the adjourned meeting.