Meet Saundra Pelletier, Chief Executive Officer of Evofem Biosciences, Inc (OTCQB:EVFM). Her tenacity, empathy and compassion have driven the business to new heights. A resilient leader, her staff will say she has held the company together by her indomitable will. She has decisively overcome numerous challenges professionally and even made it through stage three breast cancer. She now advocates for and raises funds for cancer research with a focus on early detection.
Evofem aims to empower women by commercializing innovative sexual and reproductive health products that address unmet needs and give women the control and flexibility they desire and deserve. In the company’s first therapeutic area, contraception, the best way to empower women is to give them control over when, if, and how often they get pregnant. Pelletier repeatedly states that the very best way to elevate ALL causes is by having fewer people on the planet – by choice, not by chance. If we take a moment to think about those who have perpetuated destruction and violence, historically it has not been women. “Women WILL make the right choices if given the chance,” says Saundra, “and they will make them consistently and unselfishly with others in mind.” This is why women deserve complete bodily autonomy.
Saundra geographically started her career at the furthest point in the United States from where she resides now—Caribou, Maine. She believes the kind of poverty by which she was surrounded could have easily been alleviated if women had access to safe, affordable contraception. Her pharmaceutical career began right out of college, and she has held almost every role in a commercial organization, starting by carrying a bag as a sales rep calling on Ob-Gyns with women’s healthcare products. This experience has made a real difference as a CEO, because many pharma executives have never held the one role that generates the most revenue. Her focus has always been women’s healthcare, and she is considered an expert in women’s health from puberty to menopause. Understanding the female mindset is critical to marketing products that are intended to solve problems and improve women’s busy lives. One size does not fit all and women’s needs change throughout their reproductive years.
In January 2018, she led Evofem’s transition to be a Nasdaq-listed company through a reverse merger into a public shell. Her mission is to empower women with innovative products that address unmet needs in sexual and reproductive healthcare. With a mantra of ‘Science with a Soul’, Evofem is raising the bar by putting women’s needs at the forefront. She and her team are tenacious, focused, and near-evangelical about their work and have been working tirelessly to deliver on the opportunities at hand. She is a voracious reader with high insights and opinions on political, social, and academic topics. She tries to read and review everything that impacts her company’s mission and find ways to continuously improve its corporate culture and results. Her biggest regret is that early on, after Evofem became public, decisions were made that set the company on a path she intuitively knew was misguided, but, because other powerful voices in the organization had past successes larger than hers, those ideas were enacted. She now has the chance to right those wrongs and would do so, if afforded the opportunity, but second chances are not always given.
Through Evofem’s exceptional product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), she has been able to fulfill a critical, unmet need in the contraceptive space. It’s the first and only product of its kind—an FDA-approved hormone-free contraceptive gel that women can use on-demand when they need it. It is designed for women to use at their discretion 0–60 minutes prior to each act of intercourse. Each prescription is for a box of 12 Phexxi applicators, each pre-filled and individually wrapped for convenience. It has a unique mechanism of action as a vaginal pH modulator. The purpose of semen is to raise the pH of the vagina from the normal, slightly acidic range of 3.5–4.5 to a more alkaline level where sperm can survive to fertilize the egg. Inserted before sex, Phexxi works to maintain normal pH of the vagina, which is a sperm-hostile biome, and thereby prevents pregnancy.
Consistently and correctly
Saundra highly emphasizes that contraceptive choice matters. Women should not be considered cookie cutters, as one method does not suit everyone’s unique, individual needs. The best method for any woman is the one she can and will use consistently and correctly. Millions and millions of women cannot or will not use hormonal contraception, and those who have survived hormone-sensitive cancer can never take an exogenous hormone again. “Many women have suffered intolerable side effects ranging from mood swings to loss of libido and weight gain. Also, hormonal methods are less effective in women with a high BMI,” she mentions. Until the approval of Phexxi, hormone-free options were limited to a long-acting device implanted in the uterus; a cervical cap used with a spermicide that relies on a detergent to kill sperm and increases the risk of contracting HIV; or relying on the male partner to use a condom or withdraw. In her recent SD Ted Talk, the most remembered and seemingly provocative statement was when she asked the audience to raise their hand if they had male children and then asked those with their hands in the air how they would respond if asked to give their sons a medication, every single day, for months over months, years over years, that they did not need to maintain a healthy life AND that this medication would give them side effects every single day. Yet, they must take it daily in order for it to work for the one or two times a week they might need it – but there may be times they would go months never needing it at all. Saundra exclaimed, “Doesn’t that seem crazy? Then why is it that we ask this of our daughters?” Mic drop moment. The robust audience was silent as Saundra took a pregnant pause (ignore the pun).
According to the American Diabetes Association, 1.4 million Americans are diagnosed with diabetes every year. The healthcare community throws money at diabetes like it is candy. People with diabetes count for $1 out of every $4 spent on healthcare in the U.S. In 2022, the total annual cost of diabetes was $412.9 billion, including $306.6 billion in direct medical costs.
This trend is paralleled by the flow of money from investors into companies developing potential new treatments for diabetes and obesity. Structure Therapeutics’ $161 million initial public offering (IPO) was oversubscribed and priced at the top of its range in early 2023. In November, Carmot Therapeutics filed for a $100 million IPO; others are expected to follow suit, eager to harness the capital markets to fuel clinical trial costs as they chase their share of the proverbial golden carrot.
“Medications are constantly being developed; payers cover drugs and devices and even send testing kits to patients’ homes for free,” she adds. “Meanwhile, there is another epidemic in the United States that’s twice as big as diabetes that no one is talking about—unintended pregnancy.” Nearly half of all pregnancies are unintended. In the United States, this is roughly 3 million unintended pregnancies every year, which carries an estimated annual cost to taxpayers of more than $11 billion.
Unlike diabetes, payers are doing everything they can ‘not’ to cover new and innovative contraceptives that come to market. This is despite the contraceptive guidelines under the Affordable Care Act, which clearly state that payers must cover all FDA-approved contraceptive methods at zero cost to the covered person without cost sharing. “It is despicable, and it has to stop,” she asserts.
In July 2022, the U.S. Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury clarified that enforcement actions could be taken against payers for the failure to comply, including penalties that the agencies could impose. As a result, coverage for Phexxi has dramatically increased since January 1, 2023; more than 82% of Phexxi claims are now being approved. “This is great for the go-forward business,” Saundra mentions. “The company launched Phexxi in September 2020. It should not have taken three years to reach an 82% approved claims rate.”
Interestingly, several of the GLP-1 receptor agonists indicated for diabetes and obesity can interfere with the absorption of oral contraceptives, reducing their efficacy and increasing the risk of unintended pregnancy. Women are instructed to use an alternate birth control method for the first four weeks of treatment with these drugs and for four weeks after each dose increase. “As a hormone-free, woman-controlled, on-demand contraceptive, Phexxi could prove extremely useful to women starting treatment with GLP-1 receptor agonists,” she states.
"We will rise to that challenge because we know there are investors who believe women and the unique conditions that affect women are worth investing in"
Being persistent
Saundra believes that success can be tricky for many if not handled properly. She reckons that one must never let failure go to their heart and never let success go to their head. “It is critical to inspect what you expect through transparency, continuous communication, and complete clarity on what success is for your organization,” Saundra quips. “No one should ever wonder how you are being evaluated, the rewards for success, and the ramifications of failure.” Along with that, she suggests aspiring leaders focus on the unknown challenges; they must ask each department head to play devil’s advocate, be as negatively polarized as possible, and role-play as if they are under cross-examination. “You would be amazed at the clarity of the unknowns that are extracted from this process,” she adds. To attain success, many entrepreneurs believe that the sacrifices are worth it. Saundra’s conviction is strong: innovative endeavors require people who are willing to take risks. It is about recognizing that if vision and execution align, you do what’s necessary, and the people who care about you understand.
She also never lets hurtful remarks stop her from supporting other women. Her investors sometimes criticize her and her employees, acting as though they were coerced into making an investment without taking any kind of risk into account. “I am shocked at the cruel and sometimes violent comments made that are solely female-focused. I handle these situations with martinis and voodoo dolls, because allowing their abuse to penetrate my heart and head only perpetuates their bullying,” she cheerfully mentions, “and if my voodoo dolls work, at least they won’t be procreating in the future.”
Revolutionizing health and wellness
Saundra exclaims that in the coming years, the company will be compared to the Little Engine that Could. Hormones impact the lives of women in many ways, and for those who are negatively impacted by them – which are millions and millions of women – this small company stepped up and delivered, bringing a hormone-free, woman-controlled contraceptive to market when big companies could have, but did not.
She is convinced that, shortly, we are going to see an increase in M&A in the women’s health space. “Not a single women’s healthcare-focused biotech has been acquired so far in 2023,” says Saundra. It is challenging for small, one-product companies to survive, and the space is ripe for a roll-up to combine several of these assets under one strong leadership team with a dedicated sales force. She believes Evofem could be the company to lead this roll-up. It has demonstrated its ability to grow Phexxi year over year, despite challenging market conditions, and she is confident that this can be replicated for additional, synergistic products. The challenge will be securing investor funding to execute this strategy. “We will rise to that challenge because we know there are investors who believe women and the unique conditions that affect women are worth investing in,” she mentions.
Saundra sheds light on the current state of female reproductive health. She notes that young women are more empowered now than ever before. They begin their contraceptive journey younger, and therefore it is much longer than many of their own mothers’ journeys. In the future, the company aims to continue delivering innovative products that address their health and wellness, including Phexxi, and plans to grow its portfolio with additional sexual and reproductive health products that make a positive difference and address unmet needs.
