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Sunday, September 25, 2022

Evofem Biosciences Inc (OTCMKTS: EVFM) Under Accumulation as Phexxi Revenues Grow & Upcoming Top-line Data for Phase 3 EVOGUARD Trial Looms

Evofem Biosciences Inc (OTCMKTS: EVFM) is an exciting situation developing in small caps trading just a penny over all-time lows. The Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel. Sales of Phexxi have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. Revenues are expected to continue to grow at a brisk rate, recently another highly respected national-level payer began covering Phexxi. The Phexxi claim approval rate reached a new high for 2022 at more than 72% for the month of July. 

The short-term catalyst on EVFM is the upcoming top line data for the Phase 3 clinical trial of Phexxi for the prevention of chlamydia and gonorrhea infection in women; EVOGUARD is expected in October 2022. Evofem expects positive outcomes would enable the Company to submit regulatory applications in the first half of 2023 to the U.S. Food and Drug Administration (FDA) to expand Phexxi’s approved indications to include prevention of urogenital chlamydia and gonorrhea in women. The Company’s CEO Saundra Pelletier recently said: “We look forward to the top-line data readout in October of our registrational Phase 3 trial evaluating Phexxi for the prevention of chlamydia and gonorrhea. With no prescription pharmaceuticals approved to prevent these sexually transmitted infections, we believe these potential new indications represent significant upside for shareholders, above and beyond the $7.9 billion U.S. contraceptive market which we continue to increasingly penetrate with Phexxi for hormone-free contraception.” 

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Evofem Biosciences Inc (OTCMKTS: EVFM) is 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 chlamydia and gonorrhea. The Company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. The Company expects to report top-line data in October 2022 from its registrational Phase 3 EVOGUARD clinical trial evaluating Phexxi for two potential new indications – prevention of chlamydia and prevention of gonorrhea in women.  

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. The Company intends to commercialize Phexxi in all other global markets through partnerships or licensing agreements. 

Evofem is 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. The Centers for Disease Control and Prevention (CDC) estimates that four million new chlamydia infections and 1.6 million new cases of gonorrhea occurred in 2018 alone. The number of reported cases is lower than the estimated total number because almost 60% of women infected with chlamydia have no symptoms. This is a concern because chlamydia and gonorrhea have been reported to be responsible for one-third to half of pelvic inflammatory disease (PID) cases. PID can cause serious, long-term problems including infertility, ectopic pregnancy, and chronic pelvic pain. 

Currently, there are no FDA-approved prescription products for the prevention of either of these dangerous infections. In October 2020, Evofem initiated its confirmatory Phase 3 clinical trial of Phexxi for these potential indications (EVOGUARD). The Company expects top-line results from EVOGUARD in October, 2022. The FDA has designated Phexxi, using the investigational name EVO100, (EVO100) as a Qualified Infectious Disease Product (QIDP) for the prevention of urogenital chlamydia infection and the prevention of urogenital gonorrhea infection in women. QIDP designation provides several important potential advantages to a future drug product, including possible priority review of its marketing application, and a longer period of marketing exclusivity under the FDA statutes. The FDA has also granted Fast Track designations to EVO100 for both potential new indications. 

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EVFM

EVO200 vaginal gel (EVO200), Evofem’s investigational candidate for the reduction of recurrent bacterial vaginosis (BV), uses the same proprietary vaginal pH modulator platform as Phexxi. EVO200 has been designated a QIDP by the FDA for this indication. In a Phase 1 dose-finding trial for this indication, the highest dose formulation of the study drug demonstrated reduced vaginal pH for up to seven days following a single administration. We may decide to pursue further development of EVO200 in the future. 

Phexxi, EVO200, and other product candidates in development share similar non-hormonal, acid-buffering, bioadhesive properties. However, they are designed differently to target viral and bacterial pathogens while playing an integral role to the survival of healthy bacteria in the vagina, enabling women to achieve better sexual and reproductive health. 

On September 16, EVFM announced another new insurance win that gives millions of additional women access to Phexxi® (lactic acid, citric acid, potassium bitartrate) for the prevention of pregnancy. This win, adding nearly four million covered lives, continues Evofem’s strong success record with health insurers and pharmacy benefit managers (PBMs) to increase a woman’s ability to obtain Phexxi. In 2022 alone, Evofem has opened avenues with the following payers to cover Phexxi: 

  • One of the largest PBMs in the U.S. 
  • One of the largest payers in California, with no copay for patients 
  • One of the largest payers in Utah, with no prior authorization 
  • One of the largest payers in Hawaii, with no copay for Phexxi patients 

In July of this year, the Departments of Labor, Health and Human Services, and Treasury released guidance regarding birth control coverage clarifying that group health plans and insurers must cover contraceptives at no cost to individuals. Evofem consistently engages with these payers to ensure they comply with these guidelines in covering Phexxi. 

EVFM CEO Saundra Pelletier stated:”Evofem’s diligent efforts to expand access to Phexxi nationwide continue to pay off. We are thrilled that another highly respected national-level payer is now covering Phexxi, allowing women to fill their prescriptions immediately. The Phexxi claim approval rate reached a new high for 2022 at more than 72% for the month of July, and we expect this will continue to increase with this and other recent payer wins.” 

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Currently trading at a $25 million market valuation EVFM OS is 25,877,050 shares with authorized at 500 million. With $20 million in cash in the treasury EVFM was recently able to restructure its debt, providing forbearance from its debtholders related to all existing events of default. EVFM is an exciting situation in small caps trading just a penny over all-time lows. The Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel. Sales of Phexxi hormone-free, on-demand prescription contraceptive vaginal gel sales have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. In October the Company will release top-line data from its Phase 3 registrational trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. The Company believes positive outcomes from this landmark trial will catalyze strategic discussions and enable regulatory submissions to expand the Phexxi label. EVFM has a lot of potential from current levels; some of the biggest runners in small history over the past 10 years have been ex big bord biotech’s, EVFM should be at the top of penny stock speculators watch lists here. We will be updating on EVFM when more details emerge so make sure you are subscribed to Microcapdaily.

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

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