Investment Highlights for Evofem Biosciences, Inc.

Evofem Biosciences, Inc.
7770 Regents Road, Suite 113-618
San Diego, CA 92122
Phone: (858) 550-1900
https://www.evofem.com/

• Evofem Biosciences, Inc. (“Evofem” or “the Company”) is a commercial-stage biopharmaceutical company focused on addressing unmet needs within the women’s sexual and reproductive healthcare markets. The Company’s initial Food and Drug Administration (FDA)-approved product, Phexxi®, is a hormone-free, on-demand prescription contraceptive vaginal gel. Packaged in boxes containing twelve pre-filled applicators, Phexxi is inserted up to one hour prior to intercourse and works to prevent pregnancy by maintaining the vaginal pH (a vaginal pH modulator [VPM]), which reduces sperm motility and lowers the chance of sperm reaching the egg. 
  
  
• As the only FDA approved and marketed hormone-free contraceptive vaginal gel that has no systemic activity in the body, Phexxi addresses significant gaps and underserved and unmet needs in the contraceptive market. This is important to the 23 million women who are beyond hormones and will not or cannot use hormonal contraceptives, including women who may be breast feeding or breast cancer patients/survivors.
  
  
• On December 11, 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (ADTX-NASDAQ), under which Aditxt intends to acquire Evofem. 
  
  
• On April 26, 2024, Evofem delivered a termination letter to Aditxt because the required and agreed $2.0 million investment in Evofem was not made on or prior to April 1, 2024. The Merger Agreement was immediately terminated upon delivery of this letter.
  
  
• On May 2, 2024, Evofem and Aditxt reinstated the Merger Agreement, as amended, and entered into the Fourth Amendment to the Agreement and Plan of Merger. Aditxt paid $1 million to Evofem in consideration of the reinstatement and Fourth Amendment. The companies are working toward closing in the second half of 2024. 
  
  
• While new contraceptive products have been introduced in recent years, Evofem believes that Phexxi represents the first innovative contraceptive method introduced in the U.S. since NuvaRing was approved by the FDA in 2001 (23 years ago).
  
  
• Key attributes of Phexxi include:
  
  
  • Hormone-free. Phexxi is an innovative gel that works to prevent pregnancy without the use of hormones. Since the product is entirely hormone-free, there is no concern of any hormone-related side effects, which may include weight gain, acne, headaches, mood swings, or the slight risk of blood clots, which are associated with hormonal birth control methods.
    
    
  • Use when needed. Since Phexxi is used in the moment, prior to intercourse, there is no daily pill commitment or the need to take hormones. This also makes Phexxi easily reversible, providing women with a flexible option for family planning.
    
    
  • First in class. Phexxi is the first and only hormone-free prescription birth control gel that women control. The product works to prevent pregnancy by maintaining the vaginal pH, which reduces sperm motility and lowers the chance of sperm reaching the egg. This mechanism of action is unique to Phexxi, with no comparable products available on the market.
    
    
  • Woman-controlled. Phexxi places women in control of their bodies in terms of pregnancy prevention. With Phexxi, there is no need to rely on a partner to bring a condom and no need to visit a doctor’s office for an injection or procedure to prevent pregnancy. The product is delivered using an applicator (similar to a tampon) and was developed to be used spontaneously and to be convenient.
    
    
• As of January 1, 2023, most insurers and pharmacy benefit managers (PBMs) must provide coverage with no out-of-pocket costs (e.g., $0 copay) to the subscriber or dependent for FDA-approved contraceptive products, such as Phexxi, which are prescribed by healthcare providers.
  
  
• As of March 21, 2024, the Company owned or had exclusive license to approximately 47 issued patents and allowed applications in the U.S. and other countries and jurisdictions and had approximately 16 patent applications pending in the U.S. and other countries and jurisdictions. This includes four U.S. patents, which cover Phexxi and its labeled indication through 2033, that are listed in the U.S. FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
  
  
• There is a significant opportunity for profit within the women’s healthcare market, where small percentages of market share can deliver big results. Evofem’s wholesale acquisition cost (WAC) for a box of 12 prefilled Phexxi applicators is $348.24. Factoring a 40% gross-to-net adjustment, Evofem is averaging $208.94/box (with Evofem’s cost of goods per box of twelve at ~$35).
  
  
• Partnership discussions are ongoing for the commercialization of Phexxi in international markets as Evofem intends to expand the product’s global reach and further increase its commercial potential through ex-U.S. licenses. The product is approved in Nigeria, and regulatory dossiers have been submitted in Ghana, Ethiopia, and Mexico. 
  
  
• For the year ended December 31, 2023, net product sales were $18.2 million compared to $16.8 million in net product sales in the prior year. The increase was primarily driven by more favorable reimbursements, leading to a better gross to net ratio, and the Phexxi WAC increase that took effect October 1, 2022.
  
  
• Evofem’s leadership team has over 85 years of combined experience within the healthcare and pharmaceutical industry. Together, these individuals have launched the first vaginal pH modulator, a unique mechanism of action, to bring much-needed non-hormonal innovation to the contraceptive space with Phexxi vaginal gel.
  
  
• As of December 31, 2023, the Company had $0.6 million of restricted cash versus $2.8 million of unrestricted cash and $1.2 million of restricted cash at December 31, 2022.
  
  * Updated on May 13, 2024.