Can She Make It Gel?

Saundra Pelletier’s company, Evofem, is developing a contraceptive gel that could be the biggest breakthrough in birth control since the pill. All she has to do is survive its getting approved by the FDA

Saundra Pelletier’s company, Evofem, has developed a contraceptive gel that could be the biggest breakthrough in birth control since the pill. But first she has to convince the FDA, which has turned her company down once already.

WHEN YOUR JOB involves trying to bring to market what could be the biggest breakthrough in birth control since the pill, you keep your mornings predictable. Every weekday, Saundra Pelletier gets up at 4:30 a.m., trying not to wake her 10-yearold son while she slips into her workout gear, which includes a sweatshirt with the word bullshit printed on the left shoulder. By 5, the 48-year-old single mom—who lives about a half hour from the San Diego offices of her company, Evofem Biosciences—is on the phone, often with her investors in London. At 5:30, still on the phone, Pelletier exits her garage with a quick nod to the nanny, who is on her way in. Half an hour later, she’s at either CrossFit or Fitwall, where she can work all the major muscle groups in 40 minutes. As the cool- down session begins, Pelletier bolts, already en route to her next stop and a triple soy latte from Starbucks. Since there are no locker rooms at either gym, she swings back home—the phone automatically clicking over to a waterproof speaker in her bathroom—to clean up. Back in her car, she dictates emails to her assistant, until arriving at the office by 8:30. “We get quite a lot done, actually,” she says.

But there’s always room for improvement. When Thomas Lynch, the chairman of Evofem’s board and the head of Ireland’s largest hospital group, asked what he could do to thank Pelletier for her work as CEO—aside from stock—she responded by asking that a shower be installed at the office. “So what you’re telling me,” he said, “is you want something that lets you work more?” She did. (Lynch obliged.)

In Pelletier’s list of priorities, her morning routine comes third, after only her son and her companies. That leaves her mom and her fiancé (the founder of apparel company Athleta) duking it out for fourth place.

Perhaps the reason Pelletier is so wedded to early-morning certainty is not because of any deficiencies in her relationships with her loved ones, but because her company is dealing with a level of uncertainty that most startups, and their founders, will never contend with. “We’ve had a significant amount of failure,” Pelletier concedes. That uncertainty may explain why, when everyone in her son’s class at school had to say what their parents would like as a holiday gift, her son replied: “My momma would like a dirty martini.”

For Pelletier to achieve Evofem’s goal of becoming a global leader in women’s health, for its investors to see a return, and to potentially affect women from San Diego to Malawi, she needs to successfully commercialize what is now the company’s only product: Amphora, a new form of contraceptive gel that has yet to be approved by the U.S. Food and Drug Administration.

Innovations in contraception, at least in the U.S., have in recent years been few and far between. Yet, according to the Guttmacher Institute, 45 percent of all U.S. pregnancies are unplanned. Since the introduction of the pill, many birth control advances have been new delivery methods for the same hormones that have been used for decades. But about 5.3 million women can’t safely take those hormones, often because of previous sicknesses. Millions more simply don’t want to be on hormones if they’re only occasionally having sex. When a patient asks her doctor for a hormone holiday, says Kelly Culwell, a practicing gynecologist and Evofem’s chief medical officer, “we just hand them a bunch of condoms and cross our fingers.”

A new form of birth control that doesn’t require a doctor to administer, is used only when a woman needs it, and is hormone-free would be a breakthrough. In a clinical trial, Amphora worked about as well as other contraceptive gels. It may also provide protection against syphilis and gonorrhea. Unlike other gels, Amphora doesn’t contain surfactants, which can cause irritation and make it more likely that a woman will become infected with HIV. And without hormones, Amphora doesn’t produce side effects such as weight gain, depression, or nausea. “This could be one of the biggest innovations since the first birth control pill in 1960,” says Pelletier.

That would be enough to put Evofem on the path to becoming a billion- dollar company. The current U.S. market for contraceptives is estimated to be about $6.6 billion. About 4.5 million women who are sexually active don’t use a contraceptive. Then there’s the market for preventing sexually transmitted diseases. “When I was doing my training, we wouldn’t put IUDs in anybody,” says Andrea Thurman, the director of Conrad Clinical Research Center at Eastern Virginia Medical School. “Now we put them in everybody. It’s very possible that 20 years from now,

In the world of new drugs, startup mantras like “Move fast and break things” sound silly.