For years, men have been able to carry around the potential for "sex-on-demand" thanks to the humble condom. Saundra Pelletier wants the same for women, and she's not afraid to say so.

After all, Pelletier says, it all comes back to control: what it feels like to have it, to lose it, and to grab it back.

"You can't control what other people think. You can't control what other people do. You can only control what you think. You can only control what you do," she says. "So do what you can to sway those outcomes in the best way."

It's not always easy to sway outcomes, though, even when you're dealing with what could be the most breakthrough contraceptive product in 60 years. That's what Pelletier, CEO of Evofem Biosciences, has with Phexxi, a vaginal gel that she calls a "unicorn" because it not only offers women a use-it-when-you-need-it, hormone-free contraceptive, but it is also being evaluated in a phase 3 clinical study for the prevention of chlamydia and gonorrhea in women, the two most-common sexually transmitted infections in the U.S. after the human papillomavirus.  

"This product to me, represents sex-on-demand for women without the compromises of side effects," Pelletier says. "I find it really empowering."

And apparently so did more than 55,000 women who made the choice to use Phexxi in 2021, pushing the product to over $3.5 million in net sales — more than twice the level in Q3, and ahead of Q4 estimates.

Winning male buy-in

Raising funds for women’s healthcare products in a mostly male investor environment has been a challenge for many women’s health companies, but Pelletier had a plan, and she managed to raise $5 million of non-dilutive capital in January 2022 alone.

Pelletier knew that as a female biotech CEO, she couldn't control the way male investors perceived a product that's made exclusively for women. But she could control one thing: the messenger. And she did what it took to get her message across.

"Why talk if no one's gonna listen? The art of communication is on the speaker. It's your responsibility to get people to listen and influence them," she says.

That meant controlling her delivery when pitching Evofem and Phexxi to investors. If the investors were conservative, she'd put on her best "Barbara Bush suit" and speak in a slow, subdued manner instead of her usual edgy, energetic — and sometimes profanity-peppered — style.

But perhaps her biggest power play came when she ceded control in those meetings, telling investors not to simply believe her when she told them that women would love a hormone-free birth control option that they used only when they needed it.

Instead, she encouraged them to talk their wives, girlfriends, and the other women in their lives.

"If you talk to two or three, at least one of them has had a bad experience with hormones, and some of them have had experiences that are gonna shock you," she told them. "And I promise you that I'm right about this, and you're going to be surprised."

She was right. They were surprised. And then they invested.

"When I started suggesting to them to not to take my word for it, but to instead listen to the women in their lives, that was the biggest shift that happened for the company," she says.

A new category of birth control

Phexxi works by balancing the vagina's pH and making it an inhospitable place for sperm to travel. Ironically, early on, ideas for its use — like as a condom coating — were very male-centric.

Pelletier banked on women who, like herself, were looking for non-hormonal contraception as a standard of care. She knew that women often "do not win the condom negotiation." She wanted women to have complete control over their bodies and sex lives. After all, for some women, enduring the mood shifts, cramping, bleeding, weight gain, and other side effects common with traditional contraceptives doesn't really feel like control at all.

And losing control of one's own body is something that Pelletier is intimately familiar with. In 2018, she was diagnosed with stage 3 breast cancer and told to get her "affairs in order."

"It leveled me in a way that I didn't realize I could be leveled. I didn't realize that I could feel such profound vulnerability," she says.

But Pelletier never doubted that she'd beat cancer. Moreover, her diagnosis turned her into one of the millions of women who cannot use hormonal contraceptives. In other words, a Phexxi customer.  

"Even though I felt like I was out of control, I actually thought my cancer diagnosis was cementing the company's mission. I always did this as far more than a job. But that was like a message from the universe," she says of her experience with cancer. "Like, look. You were born to do this, you know? Don't whine and cry…cancer's temporary. Get better, get over it, go back to work."

Now, that work means expanding access to Phexxi, which has been another big challenge. As if launching a product during a pandemic isn't difficult enough — Phexxi got FDA approval as a contraceptive in May 2020 and hit the market later that year in September — Pelletier and Evofem ran up against something that's even harder to control: insurance companies.

The Affordable Care Act promised free birth control, saying that one contraceptive product among every method must be covered at zero out-of-pocket cost. The FDA's Birth Control Guide lists each of these methods by category: copper IUDs, shots, patches, and oral contraceptives, for instance.

But here's the problem. Phexxi doesn't fit anywhere in that FDA Birth Control Guide, which has been panned for not including the most innovative options on the market.

"Phexxi doesn't have a category because there's no category for a non-hormonal, vaginal pH modulator," Pelletier says, and while some insurers have recognized the "spirit" of the ACA and covered Phexxi at no cost, others haven't. No category? No coverage. Plus, some insurance companies require women to fail on multiple products before they'll cover Phexxi.

But it looks as though that's about to change. Just this month, the Health Resources and Services Administration and the U.S. Department of Labor issued two separate guidances saying that most insurers and pharmacy benefit managers must provide coverage, with no out-of-pocket costs, for FDA-approved contraceptive products that are prescribed by healthcare providers, regardless of whether they're included in the FDA Birth Control Guide. This change could potentially expand access to Phexxi to millions of women.

"In 2022, we expect to benefit from this guidance, which is an important step toward securing access to Phexxi for all women at zero copay without overly burdensome denials or being forced to try other contraceptive products first. These guidelines should favorably impact Phexxi access and our gross-to-net in 2022 and beyond," Pelletier says.

And Evofem isn’t just focusing on birth control. The company is leveraging its proprietary vaginal pH modulator to develop product candidates for multiple indications, including the prevention of urogenital transmission of chlamydia and gonorrhea in women and recurrent bacterial vaginosis.The company will seek FDA approval for EVO100 (the same compound as Phexxi) to prevent chlamydia and gonorrhea, and they've already laid the groundwork for getting Phexxi to women in low- and middle-income countries, allowing them to have more of a say in what happens to their bodies.

"It offers women power," Pelletier says.