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Sparking a New Revolution for Women’s Reproductive and Sexual Health

Evofem Aims to Improve Women’s Lives Through Innovation

There are 72.2 million women of reproductive age (15-49) in the United States (Source 1). Many of them have unmet needs in the areas of reproductive and sexual health care, ranging from insufficient birth control options to the need for an FDA-approved measure to prevent sexually transmitted infections.

Evofem Biosciences, Inc. (EVFM) is a biopharmaceutical company developing and commercializing innovative products to address these needs for women. The company launched the world’s first non-hormonal, use-as-needed prescription contraceptive gel in September 2020 –  Phexxi® (lactic acid, citric acid and potassium bitartrate). Additionally, Evofem awaits top-line data from its pivotal Phase 3 trial evaluating EVO100 for the prevention of chlamydia and gonorrhea in women, for which there are no prescription products available.  They are also targeting prevention of recurrent bacterial vaginosis with a Phase 2-ready product candidate in their pipeline. 

In the U.S. contraceptive market alone, Evofem is targeting a slice of a $7 billion market and projects a $1.5 billion to $2.4 billion opportunity for Phexxi.

To learn more about Phexxi®, including use, full prescribing information and Important Safety Information, please visit www.phexxi.com

An Effective Flagship Product  

Phexxi is 93% effective at preventing pregnancy when used as directed. In the pivotal clinical trial, the pregnancy rate per act of intercourse was 0.188% – just 49 pregnancies over 24,289 acts of intercourse – when used as directed. With typical use, efficacy in that trial was 86%, putting it above condoms (85%) and diaphragms (83%), and just below the hormonal birth control pill’s 91% typical use effectiveness rating. (Source 2)

Garnering Media Attention 

Phexxi meets a critical need for women searching for hormone-free birth control, who cannot or will not take hormones. For example, approximately 800,000 new cancer cases are reported annually among women (Source 3) and many of those women are contraindicated to hormones. There is also a growing desire among women to live free of the common side effects that result from hormone-based birth control like acne, weight gain, depression, mood swings, irritability and headaches. 

Speaking to these women is Annie Murphy of Schitt’s Creek fame. As the company’s brand ambassador, Murphy has endorsed the product while sharing her own personal stories on the matter in Evofem’s ‘House Rules’ campaign. 

The celebrity DTC campaign generated 2 billion media impressions in its first month and drove a total brand awareness to 19% in October 2021. This increased awareness has contributed to a spike in new patient starts and total Phexxi prescriptions since the ‘House Rules’ launch. In the first six weeks thereafter, there were 10,700 new prescriptions of Phexxi and more than 13,600 total prescriptions, up 94% and 81%, respectively, as compared to the six-week period just before the campaign launched.

The company hit a key milestone in October 2021, with more than 10,000 total prescriptions (up 30% over September). This is a great start to the fourth quarter, and positions Evofem for continued, significant gross revenue growth. increased awareness has contributed to a spike in new patient starts and total Phexxi prescriptions since the ‘House Rules’ launch.  

These metrics demonstrate that the “House Rules” campaign is effectively reaching Evofem’s target audience, especially women who are beyond hormones. This strong initial impact bodes well for the future of the product and Evofem alike.

 

What Is Phexxi?  

As mentioned, Evofem addresses unmet needs in women’s reproductive and sexual health care. The Phexxi story is a snapshot of that mission. 

Based on data from the National Center for Health Statistics (NCHS), there are approximately 23 million women in the United States at risk of pregnancy who are not using hormonal contraception. Some of those women turn to various forms of non-prescription birth control, such as barrier methods, withdrawal, or periodic abstinence. Continuing to have unprotected sex leaves those same women with an 85% chance of getting pregnant within one year. 

Taking these numbers into account, Evofem believes a conservative acquisition percentage of those 23 million women would represent over $1 billion in annualized peak sales for Phexxi. 

How Does It Work? 

Phexxi is a hormone free, prescription vaginal gel that is applied 0-60 minutes before each act of intercourse using a convenient pre-filled applicator. The gel works to keep vaginal pH in the baseline range of 3.5 to 4.5, lowering sperm mobility and the chances of contraception. 

Because Phexxi is a non-hormonal birth control, it is not associated with side effects like acne, weight gain, headaches, depression, mood swings, and irritability that are common with hormonal birth control. Phexxi offers women freedom from a daily ritual, invasive procedures, or an injection from their physician to protect themselves from unwanted pregnancy — all of which represent a growing list of reasons women are seeking new, safe contraceptive options. 

Expanding the Prescriber Base While Growing Prescriptions 

Phexxi was made available to the American public in September of 2020 after receiving approval from the Food and Drug Administration. In Q3 2021, over 19,000 Phexxi  prescriptions were filled, a 48% increase from the prior quarter.  And with the more than 10,000 Phexxi prescriptions in October 2021, Evofem is on track for another strong quarter of Phexxi prescription growth.

When Evofem surveyed 127 women who participated in the  Phexxi concierge experience, they found that 89% reported they planned to refill their prescription and 82% indicated they were either likely or very likely to tell a friend of family member about the product, confirming potential for a growing consumer base with Evofem’s premier product, via word of mouth alone. That is VERY powerful. As shown by the chart, of the new Phexxi users, 29% switched from oral contraceptives and 7% switched from rings and patches. These numbers are highly encouraging, as they indicate the Phexxi’s ability to capture consumers formerly loyal to other methods.

“Clinicians have been reaching out to me saying everyone’s asking for Phexxi,” says Dr. Meera Shah, chief medical officer for Planned Parenthood in the Hudson Peconic region. “The demand is there.” 

The Evofem Pipeline 

Beyond the flagship product, Evofem has other candidates in various stages of development. They aim to expand the Phexxi label to include prevention of urogenital chlamydia and gonorrhea in women with EVO100. Tackling this growing STI problem can aid as many as 3.84 billion women worldwide (Source 4) and 72.2 million women in the United States (Source 5). The company is also developing a vaginal pH modulator for the prevention of recurrent bacterial vaginosis (BV), a vaginal condition with a prevalence in the United States estimated to be 21.2 million (29.2%) among women ages 14-49 (Source 6). 

EVO100 / EVOGUARD 

“EVO100” is the codename for the development of Phexxi for the prevention of chlamydia and gonorrhea in women. It has been granted Fast Track Designation for both investigational indications, and is designated a Qualified Infectious Disease Product (QIDP) for the prevention of gonorrhea in women by the U.S. FDA. 

The mechanism of action in preventing these two STIs the same as in contraception – pH modulation.  Maintaining the normal vaginal pH of 3.4-4.5 helps maintain healthy vaginal flora and creates an environment that is detrimental to the growth and proliferation of chlamydia and gonorrhea, among other bacterial and viral pathogens that may offer future pipeline expansion opportunities for Evofem. 

As mentioned, EVO100 is investigational and its safety and efficacy are currently being evaluated. The company expects to report top-line results of its pivotal Phase 3 trial, called EVOGUARD, in the second half of 2022. Assuming favorable outcomes, Evofem will file a Supplemental New Drug Application (sNDA) in the first quarter of 2023, and a subsequent FDA approval would enable commercial launch for these new indications by the end of 2023. This is because of the six-month review period afforded by the Fast-Track Designation; standard review is a ten month process. Approval for the prevention of chlamydia and gonorrhea in women would be a groundbreaking step for women’s sexual health care, as it would make Phexxi the first Rx product approved for prevention of these common STIs.  

Vaginal pH Modulator

Evofem is currently developing an investigational drug candidate for the prevention of recurrent BV infections. Like chlamydia and gonorrhea, BV-associated pathogenic bacteria is also pH sensitive, so the same mechanism of action underlying Phexxi is relevant in BV. 

The Phase-2-ready product is designed to reduce the recurrence of a prevalent and unpleasant infection that, in pregnancy, can be associated with drastic complications to both mother and child. BV also increases the risk of acquiring HIV and other STDs. (Source 6) 

Addressing the Market 

The addressable U.S. market opportunity for these current products and investigational candidates is estimated at $3.6 – $4.5 billion in aggregate. 

 At the time of this writing, Evofem continues working to increase the number of lives covered and to gain preferred formulary position for Phexxi and is aggressively pursuing an Affordable Care Act (ACA) strategy. As of October 2021, 70% of Phexxi prescriptions are being approved either by payers or through Evofem patient support programs. They have coverage for approximately 55% of U.S. commercial lives, including 9 million lives covered at no out-of-pocket cost and approximately 13.7 million lives covered under a December 2020 contract award from the U.S. Department of Veterans Affairs. On January 1, 2021, the U.S. Medicaid population gained access to Phexxi through Evofem’s participation in the Medicaid National Drug Rebate Program. Medicaid provides health coverage to approximately 68 million members, including 16.8 million women 19-49 years of age. Currently, the ACA mandates 18 specific methods of contraception be covered without any out-of-pocket costs. A new “vaginal pH modulator” category would facilitate unrestricted access to Phexxi at $0 out-of-pocket cost to women.  

Outside of the U.S., the company intends to expand Phexxi’s global reach and further increase its commercial potential through ex-U.S. licenses. Discussions are underway with potential licensees for the commercialization of Phexxi in multiple international markets. Likely initial opportunities include Latin America, the Asia Pacific region, and/or global (excluding the U.S.). Evofem targets having its first license agreement in place by year-end 2021.

Meanwhile, in October 2021 submitted the registration for FemidenceTM  for hormone-free, on-demand birth control to the Mexican Regulatory Agency COFEPRIS.

 

In the News

 

Press Releases

 

Management

Evofem’s leaders hold over 85 years combined experience in the healthcare and pharmaceutical industries. Its team successfully conducted clinical trials, navigated the FDA review process, secured FDA approval, and launched the first vaginal pH modulator, Phexxi®. 

Since launch, leadership has implemented a successful strategy that is resulting in dramatic growth in prescriptions, units dispensed, and consumer base – all during a pandemic. Evofem will surely change the contraceptive landscape, and a huge part of that is its world class team led by Saundra Pelletier, a 25 year veteran of the healthcare industry who has served as Evofem’s CEO since February 2015 and through its transition to the public market in January 2018.

Learn more about Saundra and the team at: https://www.evofem.com/about-us/management/

 

Sources:

  1. https://www.cdc.gov/nchs/products/databriefs/db388.htm
  2. https://www.cdc.gov/cancer/uscs/about/data-briefs/no17-USCS-highlights-2017-incidence.htm
  3. World Bank staff estimates using the World Bank’s total population and age/sex distributions of the United Nations Population Division’s World Population Prospects: 2019 Revision. https://data.worldbank.org/indicator/SP.POP.TOTL.FE.IN
  4. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14
  5. https://www.cdc.gov/std/bv/stats.htm
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859802/#B13

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  • Period of Campaign - 09/30/2021 - 03/30/2022
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