Evofem Biosciences (NASDAQ: EVFM)

Check out this interview with Evofem Bioscience CEO, Saundra Pelletier https://youtu.be/ExLMIyNNqic.

Also, here is a great article in Inc. Magazine about this dynamic lady who is changing women’s health forever.

Evofem Biosciencewebsite: https://www.evofem.com
Phexxi website: https://www.phexxi.com
Evofem Bioscience Investor Overview: https://evofem.investorroom.com

Evofem has been hammered by the shorts, who will probably be forced to cover. Evofem did a 1-for-15 reverse stock split on Thursday, May 5, 2022, which left the company with about 12.5 million shares outstanding at roughly $1.10 a share. So, yep, that’s a market cap of $14 million!

Here’s where it gets good: Evofem posted $8.24 million in product sales for fiscal 2021. Not only did Evofem, with its ridiculous $14 million market cap, do $8.4 million in sales for 2021, Evovem did$4.3 million in sales in the first quarter of 2022! You know why this is a big deal, and why it gets me excited about EVFM? Because, according toCSIMarket, the average Biotechnology & Pharmaceuticals Industry stock trades at 5.47 times trailing 12-month sales! So, EVFM should have a market cap of around $65 million. With 12.5 million shares out, that’s around $5 per share! If that’s not enough to get your small-cap stock infused blood pumping,Evofem said on its May 4, 2022 analysts call the company “expects 2022 net product sales will be in the range of 30 million to 35 million based on the current business with momentum building in the second half of the year.”

I struggled with advanced math in college, but I know how to multiply. $35 million in sales times 5.47 for the average Biotechnology & Pharmaceutical Industry stock. According to my calculator, it comes out to more than a$190 million market cap. You divide that $190 million market cap by 12.5 million shares and we are looking at a $15 stock price! Let’s say I’m half right. Maybe even figure that, like most biopharma companies, Evofem issues some more shares to raise some cash to execute on its business plan. So, say I’m 25% right. If I’m 25% right, and the stock goes to $3.75 from $1.10, you will probably be happy with a triple. With this crazy market we’re in, some of you would probably be happy to buy a stock that trades higher!

Phexxi – The First and Only Hormone-Free, On-Demand Prescription Contraceptive Vaginal Gel

In the interest of getting you timely information, this is copied directly fromEvofem’s website. I encourage you to do some more research. Phexxi vaginal gel provides women an in-the-moment contraceptive that can be easily applied 0-60 minutes before each act of intercourse and works by maintaining the baseline vaginal pH environment.

Baseline vaginal pH levels can range from 3.5 to 4.5. When semen enters the vagina, it raises the vagina’s pH level, which allows sperm to be mobile and swim up the reproductive canal. Phexxi works to keep vaginal pH in the baseline range of 3.5 to 4.5, which lowers sperm mobility, lowering the chance of sperm reaching the egg.

Women should not have to rely on a daily ritual, their partner, an invasive procedure, or an injection from their physician to protect themselves from unwanted pregnancy. Many women seek a safe, FDA-approved localized method of birth control that does not require the introduction of hormones into their bodies.

Because Phexxi is a non-hormonal birth control, it is not associated with side effects like depression, mood swings and irritability. Taking hormones may not be right for some women, especially for those with certain medical conditions including clotting disorders and most cancers, limiting their birth control options.

Phexxi provides a hormone-free contraceptive option for women who cannot or do not want to use a hormonal contraceptive as their birth control method. Phexxi is the hormone-free birth control women have been waiting for.

Proven Safe and Effective

Phexxi is 93% effective at preventing pregnancy when used as directed by a healthcare provider.

Phexxi is 86% effective with typical use; typical use includes women who may not have correctly followed the Instructions for Use during the clinical trial.

2011 Affordable Care Act = Free Birth Control

This is not being enforced, but it will be on January1, 2023. This is going to be a big win for EVFM!

In 2011, President Obama signed thebirth controlmandate into law as part of theAffordable Care Act (ACA). Since thebirth controlmandate came into effect, the number of women without-of-pocket expenses towards contraceptives dropped from 21% to 3%. What most people understand about the mandate is thatbirth controlbecame free.

Before thebirth controlmandate passed, women were required to pay out-of-pocket costsforbirth controlalongside theirhealth insurancepremium and yearly deductible. After thebirth controlmandate was signed into law, women in theUnited Statesno longer had to pay those out-of-pocket costs, as theACArequiredinsurance companiesto covercontraceptive methodsand counseling even if they hadn’t met their deductibles.

Roe vs. Wade

TheSupreme Court has voted to strike down the landmark Roe v. Wade decision, according to a leaked initial draft majority opinion written by Justice Samuel Alito. Maybe it’s true, maybe it’s not? If it is true, FDA-approved contraceptives, like Phexxi, are going to be in big demand.

Chlamydia amd Gonorrhoeae

Evofem is also involved in the development of EVO100, an antimicrobial vaginal gel for the prevention of urogenital transmission of Chlamydia trachomatis infection and Neisseria gonorrhoeae infection in women. Evofem’s pipeline includes programs developing Phexxi for the prevention of two common STIs and EVO200 to reduce recurrent Bacterial Vaginosis (BV).

Every day, more than 1 million new cases of sexually transmitted infections (STIs) are acquired worldwide among people aged 15-49 years.4Every sexually active woman, no matter what form of contraception she is using, is potentially at risk of contracting an STI.

In the United States, the CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred in 2018 alone.6 The number of reported cases is lower than the estimated total number because infected people are often unaware of, and do not seek treatment for, their infections. Almost 60% of women infected with chlamydia have no symptoms.

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.8

In 2020, Evofem initiated EVOGUARD, a confirmatory Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 (the investigational name for Phexxi) for the prevention of urogenital transmission of chlamydia and gonorrhea in women. Top-line study results are expected in the second half of 2022.

The U.S. Food and Drug Administration granted EVO100 (Phexxi) Fast Track designation for the prevention of both chlamydia and gonorrhea. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

Additionally, the FDA has awarded EVO100 (Phexxi) Qualified Infectious Disease Product (QIDP) designation for the prevention of both chlamydia and gonorrhea in women. A drug that receives QIDP designation may qualify for an additional five years of marketing exclusivity.

EVOGUARD builds on the positive, statistically significant results of the Company’s AMPREVENCE Phase 2b clinical trial. This landmark study met its primary and secondary endpoints, demonstrating a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo.5 The AMPREVENCE manuscript was published in the prestigious peer-reviewed journal American Journal of Obstetrics and Gynecology in 2021.

Assuming FDA approval for these potential new indications, Phexxi is expected to be the first prescription product approved to address this critical large unmet medical need.

Summary

Evofem Biosciences is packed wall to wall with great management and board members. Phexxi, is an FDA-approved, hormone-free, on-demand prescription contraceptive vaginal gel method of birth control used for the prevention of pregnancy. Not only did Evofem increase Phexxi net product sales 19% to $4.3 million for the first quarter of 2022 vs. fourth quarter 2021, The U.S. Food and Drug Administration granted EVO100 (Phexxi) Fast Track designation for the prevention of both chlamydia and gonorrhea. Evofem reduced its selling and marketing costs by 49% and its total operating expense by 19%.

Evofem Biosciences has a huge short position that could spark tremendous buying in the stock!

Evofem received confirmation three weeks ago from one of the largest Pharmacy Benefit Managers (PBMs) in the nation that they will add Phexxi to their national template formularies with no restrictions. PBMs are companies that manage prescription drug benefits on behalf of health insurers, Medicare Part D drug plans, large employers, and other payers. Three large PBMs — CVS, Express Scripts, and UnitedHealth’s Optum — account for more than 70 percent of claims volume. Great news is coming from the Affordable Care Act on January 1, 2023, as the rule requiring insurance companies to cover contraceptive methods and counseling with no deductible is enforced. There are no toxic convertibles and management owns a lot of shares. The stock is trading at its 52-week low with an incredibly low valuation for a growth company.