Sex on Demand for Women — Saundra Pelletier

There’s this kind of pattern you can see sometimes, when you dig behind very successful projects, a lot of times there is some woman who is dead set on making it happen. And for a lot of them, she’s working behind the scenes and you don’t find out until you get real close, what’s really going on.

But occasionally you meet these women who are badass leaders that are so dogged that they’re going to make something happen by force of will. And I’m always honored to get to meet them. Today we get to spend some time with Saundra Pelletier, the CEO of Evofem Biosciences.

This is a super fascinating company that is dedicated to creating medical and healthcare products for women. You don’t find a lot of companies focused on that, which is sad because women are the ones who drive a lot of the healthcare decisions for their entire families. So I don’t understand why the market hasn’t picked up on that one.

I think you’re going to love Saundra. She’s created a product at her company called Phexxi. It is the first and only FDA approved, non-hormonal contraceptive gel for women. They can use it anytime on demand whenever they want. This is the kind of product that is really important to change the balance of power and determining who ends up procreating and when. We want that control to be in the hands of everyone, but in the past, a lot of the responsibility has landed on women and, they’ve been given, in some sense, relatively crude tools to do it. Most women in America at least are using a hormonal contraceptive, which has a lot of additional health side effects.

As Saundra will tell you, she developed late stage breast cancer. She survived through a double mastectomy but the doctors told her the only real reason that she probably had cancer, in the first this place was being on a hormonal birth control for 20 years. Lots of stories like that, that you probably know and have heard with your own friends and family.

So I think this is a very important project. This type of advancement in a technology that changes what humans can do,  when they can do it, who has the decision-making power is important. We have a lot of options here where I’m at, but when you look globally at what’s happening with contraception in other countries especially in the developing world, there’s a lot of social stigmas that affect what women can get away with when they’re trying to find contraceptive choices.

Giving them some options is paramount, not just because I would like to see population managed in a more thoughtful fashion. And hopefully create a few less humans that we don’t have a plan for, but also to give them the ability to choose when the time is right, who the right partner is, what they want to do,  and not have to subject themselves to the entire weight of society’s idea about what they should do with their lives. That’s important, I believe for humanity as a whole. And so I’m really excited about Phexxi getting some support.  Evofem Biosciences is publicly listed. So I certainly  don’t want to give anybody investment advice, but these are some folks who could really use some help. And if they can get enough support for this company, they’ll be able to take Phexxi around the world and that’s gonna make a big difference for a lot of people.

I hope that you guys love this very soulful conversation I got to have with Saundra, and I’m thrilled to be sharing her with you.

Pablos: What I’m really excited about here is that I think the things that matter in the world for humans to do is how we’re gonna evolve as a species. How we are going to keep going? How are we going to make it possible for more lives to exist? And but also for those lives to thrive in some sense, right? And when you look at what has worked so far in all of human history, it’s humans inventing a new technology, bringing it into the world, solving a problem at a bigger scale, and being able to advance the species. That’s really how we got where we are and we’re not done…we might be done. But we might also be able to effect our fate go forward. And so it is  super exciting to me because, one of the biggest problems in the world in some sense is that we went from millions of people on this planet just a couple hundred years ago to billions of people in the last 200 years. 7 billion in 200 years. And we’re making a lot of extra people. It’s not totally clear that we need them all, but I’m not going to tell you which people are extra. I just think that it might be smart for the species as a whole to figure out if we want to course correct on that a little bit and maybe in the future make a few less. And maybe less but better people would be a goal. But anyway so I know Evofem is…I don’t know if you are fixated on contraception. Is that the only thing guys trying to do or want to do, or is that just the main thing where you started?

Saundra: That’s the main thing where we started. I will say this to your comment. I just want to tell you this, that not only do I find your opening statement provocative but I actually believe that one of the biggest levers to poverty elimination, as we evolve is for women being able to choose when and if, and how often they have children. Access to contraception that they’ll use is a huge poverty eliminator. So yes, contraception is our beginning. But we also are in late stage phase three development for the prevention of chlamydia and the prevention of gonorrhea with the same product. Which by the way, the CDC has said they are on the rise for the sixth year in a row. And gonorrhea, it’s an epidemic because it’s antibiotic resistant. So we’re really leaning into innovation. And that’s why it’s so cool.

We’ll pick this all apart, but just to get the audience up to speed, why don’t you describe the product you have

Okay. So the company Evofem Biosciences, the whole platform is innovation for women. And that might sound like great words, but we are  delivering. So there has not been innovation in the contraceptive category in two decades. So our product is called Phexxi, not just because it rhymes with sexy which is a nice attribute. So here’s it works: it is a gel that comes in a pre-filled applicator. And I know your audience is hearing us, but I’m going to show you. A prescription is a box of 12 pre-filled applicators, and you put it in right before sex or up to an hour before sex. Now women have used tampons.

It’s scary to guys.

It might be scary to guys, although I will tell you…

But the guys will get to use it.

Not only that but guys really love the fact that this is very lubricating. So if any woman has vaginal dryness or pain with intercourse. But here’s how you see. So 5 mLs in each applicator.

Is that the whole dose?

That’s the whole dose.

Okay. So what I’m seeing is like a size of three or four jelly beans worth of gel.

Yep. And you can feel it.

And it just feels like Vaseline or something.

Yeah. And the gel is just so you know, it’s lactic acid, it’s citric acid and potassium bitartrate. And here’s how it works. So a normal vaginal pH is 3.5 to 4.5. When semen enters the pH goes to seven or eight, and a woman gets pregnant. When chlamydia enters and when gonorrhea enters, the pH goes up to seven or eight and a woman gets a sexually transmitted infection.

So what Phexxi does is it is acid buffering. So it helps the vagina just maintain normal vaginal pH inhospitable to semen and inhospitable to STIs.

It keeps it low.

Correct, so there you have Phexxi. So just like men who have had condoms forever. So for example, you could go out with a condom in your pocket and can have safe sex, but women have had to use a hormone every day, every week, every month, year after year. And the side effects…

Doesn’t it seem like a  lottery winner for the few women who take the pill and don’t have a problem?

Yeah. Without question. Want to hear something crazier? I say the worst trick played on women is that most hormones lower your libido. So they’re taking a drug every day that makes them not want to have sex. And they’re having side effects of headache and weight gain  and bleeding. And the one crazy part is that I talked to a lot of young women and they say to me, they were put on an antidepressant or  put on an anti-anxiety product. And then when someone really looked at their levels, they realized it was their hormonal birth control. And once they got off of this hormonal birth control, they felt normal again.

Yeah,  I’ve experienced that multiple times as a close observer.

And by the way, women don’t have sex every day, which you may, or may not have experienced. But like seriously for example, would you take something everyday if you were having side effects that you didn’t even need to save your life.

Well, men don’t have to do that, but I get your point. Okay cool. If I’m using this, can I also use lube?

Yes. You can use lube. You don’t have to use a condom. Like any contraceptive it says it can’t protect you against HIV. But the  wonderful thing about this product, are you ready for this? So in the United States, half of all pregnancies are unplanned. So I want you to imagine that the pill was introduced, even now. There’s 18 categories of contraception. They pill came out in 1960 and still all pregnancies are unplanned because 23 million women identify as saying, we are not going to use a hormone. We’ve tried pills, patches, IUDs . We are beyond hormones and they say stuff like, look, I don’t have hormones in my milk. I don’t have it in my meat. And I joke and say if chickens can be hormone free…come on! Why do women have to put up with hormones? So these women are saying like, I do yoga and Pilates and eat healthy and I care about my longevity. Why am I going to take a synthetic hormone? It doesn’t  make sense. But 23 million women is our target audience and those women are without question very engaged.

They are ready to go.

Yeah.

A of times these technologies, we take them for granted because  it’s what we’re used to now, but that’s just the best technology we had at the time. Fucking with your hormone cycle was the best technology we had at the time. Now we can do better. This is an example of being able to do better. And it seems remarkably straightforward. I’m looking the box it has the ingredients listed.

And by the way, I joke that like I could make this in my garage. I don’t, but it was originally developed by Rush University in Chicago. And when they developed it as a vehicle looking to do HIV prevention studies. So at the time in the early 2000s, there were a whole bunch of academic institutions who said, we need to find something for HIV prevention. But those studies are very challenging, like in South Africa with vulnerable populations. And so the majority of those failed. So what Rush University knew this product is considered to be something called an MPT, multipurpose prevention technology, which means has the capability  to continue to look at areas. So contraception, sexually transmitted infection, bacterial vaginosis. So they knew getting to market as a contraceptive would be the quickest way to get it approved by the FDA.

Okay. So we’re going to play all the legal disclaimers for this, but we’ve got this thing approved already as a contraceptive and it’s on the market. If you want to buy it, you can get it at a pharmacy or where?

Yes, you can go to https://phexxi.com/. We have a concierge, or you can go to your doctor, and they can give you a prescription, but if you go to our website, you can it mailed to you within 24 hours.

Okay, cool. And then the way it works is you install it using a tampon.

Yeah. And throw away the applicator.

Load it up and  throw it away.

Yep.

You’re good to go to have sex and get started within an hour.

Correct. Yes, as long as you put it in right before or within an hour.

What if you’re an all night operational?

Well, you got to use it again. Good for you by the way!

Okay. And then you’re currently working going back and doing trials for some other benefits that it already provides, but aren’t already approved and aren’t already proven and phase three trials, whatever. So that’s the work now?

That’s correct.

And then what hope to show with those is?

The prevention of chlamydia and the prevention of gonorrhea. And just to give you an indicator of how pervasive those are: in the U S there’s 1.8 million cases of chlamydia annually, and 600,000 of gonorrhea. And for the sixth year in a row, the CDC has said both of those are on the rise, is antibiotic resistant and literally there are no products approved for the prevention of either of these.

And look, I want to tell you why some people say to me, why the hell, hasn’t a bigger company with a lot more money done this? And I say, look, number one, it’s easier for them to just come out with a lower dose of hormones. So they’ve got something and they come out with new ways of giving you hormones. And by the way all it is that women aren’t stupid. Come on. They understand that it’s still a hormone. Just because it’s in a patch, doesn’t mean it’s not a hormone. Just because it’s in an IUD, doesn’t mean it’s not a hormone. So they come up with lower doses because it’s cheaper and quicker. But we have really taken the heart painful work of developing this new innovation. But the good thing is that the year, the FDA has given us a fast track review for chlamydia and gonorrhea. So we’ll have a six month review instead of a month review. So we’re excited about that. I have to be honest right now we are getting so much positive response from women on this product and that is phenomenal.

So let me ask a couple questions. If you get through all those trials, then the same product will be approved and could even be prescribed in some sense.

Yes.

If maybe if you don’t care about like I got fixed, but I am excited because I still get to use this product

Yes. And women who cannot get pregnant, they can still use it to prevent chlamydia gonorrhea.

Yeah. Or will be able to. And I think one of the things you mentioned that I think is important to point out is a barometer for whether something is worth developing, whether it’s a good idea or whether it’s gonna work or whether it’s any of those things is not whether or not existing medical technology companies who got around to working on it. That is not a good metric because, I think one of the things you alluded to earlier is the market, that they go after 23 million women in their minds probably isn’t enough. And maybe partly because it’s only 23 million and partly because it’s women. And so we’ve got to find a way to change those dynamics and show that this is a viable market. We’ve gotta be able to show that we can make products that are profitable in that market. And that seems like the more pioneering thing that you’re doing as a company.

I have to tell you, I love you for saying that. Because you gotta think about it this way, right? When you really evaluate, women are really the healthcare consumers for themselves, or their husbands, for their children, for their parents. When they get older. If you can get the right positive lever in a woman’s mind as a company, right? A woman trusts you and thinks you really care about innovation: 1) They are the consumers and 2) to your point, they’re half of the population, but 3) so little innovation is introduced to women. I have gotten a lot of investors will say to me, if it’s not immuno-oncology, diabetes is man and women, heart disease is man and women. This is just and women and we don’t know if we’re interested. And I say, listen, I want to remind you’re here because of a woman. And at the end of the day, when a woman’s quality of life is better because she feels better. She doesn’t feel a little crazy because she has a synthetic hormone in her body and when she doesn’t feel that she’s suffering every day. You know that whole adage, when mama’s happy, everybody’s happy? This product is so important because women now are more empowered than ever. And they’re saying to themselves: I need to care about my longevity. This isn’t just about having sex with my partner. I need to be around for my kids. Women really getting savvy on what are the silence sins that happen when I take something that I don’t even need everyday. Some girls start the pill when they’re 17 and they stop taking it when they’re 35.

Oh yeah. It’s it seems insane to me. So we haven’t really done better than—we’ve done slightly better than the pill—but basically haven’t done better than hormones. If you took hormone based contraceptives for women out of it, what’s the second most popular contraception like in America?

After hormones, I would say that condoms. Withdrawal is actually considered a method. I think it really is considered a method

Don’t try that at home, kids!

Yeah. But I would tell you this, there is one other non-hormonal product, but it’s a copper IUD. It has to be put in by a provider and taken out by provider. And it has pretty intense side effects of abdominal pain and bleeding.

I’m always shocked by that one too, because basically the idea with the copper IUD is that you’re living with a wire inside of you that’s supposed to scrape the wall of the uterine lining. And it’s just seems so primitive.

And you have to think about that, right? You know what I said the other day, I was talking to a friend of mine and she is into yoga, into meditation, and  she rides her Peloton every day. And then I said to her, and then you go and you pop your synthetic hormone. I said why don’t you swig whiskey and and smoke a pack of cigarettes tonight?  I’m like what the hell are you doing? You need to look at your total healthcare!

Whiskey and cigarettes!

You want to know what else is awesome? This doesn’t have systemic side effects. It doesn’t matter what your weight is. It doesn’t matter what are concomitant medications you are on. So I talked to ER doctors and they said when somebody comes in and something happens, if there’s an event they have to give a woman contraception, they know if they give her this they don’t have to worry because there’s no hormone.

Okay. This seems like dream product to sell. How hard could it be to talk people into buying and using this product? I feel like I could have girl scouts sell them in front of Safeway.

I’ll tell you this. You know wha? It’s a double-edged sword. So when we did our direct to consumer campaign called Get Phexxi on Valentine’s day when we launched the commercial, everything changed. Our units doubled. So the FDA requires to educate doctors first, before you can go out and talk to women. So women get this so intuitively, it’s amazing. I obviously love women, but I love women everything from the brain, backbone, and soul. It has been a challenge in two ways. When talking to some male doctors, some of them will say things like, these women don’t want to have something on demand or something they control, rather they should have an IUD.

And I say, look half of all women won’t use something that they can’t control. And if you take a moment to think about and counsel your patients and let them know that this is available you would be surprised. For example, even the simplest thing like  breastfeeding women, they don’t want hormones in their breast milk. And women are spacing their pregnancies. They don’t want to put up a hormone in their body, that they then have to  cleanse out of their body before they can get pregnant again. And I said there’s, by the way, there’s lots of young women between the ages of 18 to 25 that say, are you kidding? I don’t want my mother’s contraception. I don’t want something draconian. Why wouldn’t we just put this in our pocket and put this in our purse? But so the challenge has been to convince some providers who have old mindsets

Because they have to prescribe it?

Correct.

How much of the market do you expect to be provider’s suggesting it versus women going and asking for it?

I think it’s going to be 75% women asking for it and 25% of people prescribing it. No question. So women are driving the demand.

But even considering these old fogy doctors, it seems like you’ve got a compelling enough product and story should be able them in the dust and say okay thanks, anyway and move on to the next one. How hard could it be to find gynecologists or doctors who want to get behind it?

And now we just started to expand to say how about all the women? There’s 23 million women that won’t use hormones, but there’s also a lot of women that can’t cause they’re contra-indicated. So there’s a huge amount of women that they’ve had a cancer, many of them can never use a hormone again. So we’re starting to now talk to oncologists. I just did a keynote oncology conference for a group called Ncoda. And was remarkable to see that one of the really cool oncologist said to me, I got to tell you something. When I see male patients who have prostate cancer privately, the first thing they say to me is can I get an erection again? She said, I want you to imagine that if a woman came in and said can I have an orgasm again. So do you know what we would think? We’d say, what is wrong with her? You just saved her life. Why is she worried about it? But women are so worried about the disruption of their partnership. They want to go back to the life they had before. They want their intimacy. They don’t want to be left because they’re a cancer patient. They don’t want to deal with that stigma forever. You want to get better and beyond, move on, and have your life again. And so that’s what I found fascinating is that because this is lubricating, that after you have cancer often times you are on anti-estrogen products, which produced vaginal dryness pain with intercourse. And this lubricating product with no hormones, it’s perfection for these women.

Yeah. Okay. Good. All right, so can we go talk about where this can go? How long you’ve been on the market?

Just since May of last year.

Less than a year in and the job is to go sign up doctors. So do I need to tell my doctor about it or how does that work?

Yes. So a few things. We are educating doctors and we’re educating women. So we’re doing direct to consumer advertising with social media influencers. We have an incredible 20 social media influencers that cover all demographics. So they’re influencing—incredible and extraordinary. So social media influencers. We have ads on Hulu and Bravo and all the channels of our target audiences. We’re also doing the same journals and CME programs and sending it out to doctors. Women are either going on phexxi.com. We have a concierge program, which means that you click in and a provider interacts with you. They ask you all the right clinical questions and as long as you answer all the right questions, boom, you get it sent to your house.

They can can do a prescription.

Or they go into the doctor’s office and say that I want this non-hormonal option backseat and boom. And by  the way, they can go in and say you know what  I’m having sex more than 12 times a month. So their monthly prescription could be 24. It could be two bucks, depending.

Yeah. Oh, okay. Otherwise get on a drip and it comes in the mail every month.

Exactly.

Is there a shelf life to this stuff?

Three years.

Okay. Can I use it with toys?

Yes, definitely. Definitely. Definitely. And I would you our chief commercial officer—once we have world domination—he has big plans. He’s like we should do flavor.

Is there anything sitting between you and world domination, other than time? It sounds like this is a slam dunk, but what’s the hard part now?

Money.

You need more money to do more advertising? You can’t grow fast?

Yes, because what happens is direct to consumer advertising is super expensive. Oh my goodness. It’s super expensive. And so here’s our issue: I am convinced we have the right product. I am convinced that we have the right team and I’m convinced we have the right strategy. However—not that I’m on an island—but when you have an innovation that has no benchmark that has never been done before. When you’re doing uncharted territory. Sometimes people are like I’ll wait and see and once you’re successful, I’ll give you the money you need. Then how are we going to get successful f you don’t give us any money we need? The classic chicken and egg. Now we have had some amazing investors who know the category very well. They not only are believers, but they recognize that there’s a huge need for innovation within women’s health. It is almost like it’s like a joke. It is like me telling you I’m going to grow a third eye right now in the next five minutes. People don’t innovate in women’s health because to your point, it doesn’t impact both the male and the female population. So we have some great investors, but raising money is hard. It’s very hard. Admittedly, I don’t want to be a cry baby because I signed up for this and look, I was raised raised in the northernmost city in the US, in a place called Caribou, Maine. It is the Northern most city you can fly to from here.

I grew up in Anchorage, Alaska. So I don’t think you quite convinced me of that, but I’ll take the word for it.

There were probably should have been a military general. She was like, you can be sad for one day. You got 24 hours to feel sorry for yourself and that’s it. You know what I mean? Yeah. So she would be like suck it up buttercup, you know what I mean? Like she’s hardcore women, but my point in telling you that is that what has been a little bit hard is that there is a group of not long-term healthcare who understand pharmaceutical launches in the category and how it’s done. And look, it takes time to build demand. You gotta educate doctors. Then you gotta educate women. Then you’ve got to drive them in. Then they’ve got to get prescriptions. Then they got to get refills. And it’s not like we’re not going to get there. We’re already on our way, but it just takes a little bit of time. And there’s some impatience that exists with some of the retail investors.

Who invested in iPhone apps.

Yes!

That were dreamt up last week and were supposed to be worth a billion dollars this week.

When they get angry, they go on social media and the stuff that they say, it’s staggering to me. A t first, I was reprimanded by our counsel and our advisors said I should not engage. Because I said, who raised you? Like  why would you say this to another human being, for God’s sake? Like these things are violent and vile. And that, I will admit and it might make me sound naive but that that gobsmacked me and shocked me. And then I had to grow a pair. And I have strong backbone, but I needed to strengthen it a little more to just be like, you know what? I just gotta my head down because you know what the best revenge is? Results and success. So I’ve had to really shake that off. But it’s not always easy for me to shake it off.

Look I get it. It’s hard. This is a world where there’s just an epidemic of bad behavior on the internet and there’s no way to hide from it. And I think if you look, there are very few successful examples of engaging.

I couldn’t agree more.

You got to take the high road. It’s really sad that you have to have that experience and that you have to even have the same problem. I have the same problem if I read the comments, I’m like oh my God. But I think the right answer is you gotta stay focused on what you’re doing and what you’re good at and just ignore them. They’re not your audience. Ans hopefully your audiences and listening to them, anyway,

A great person from our audience and one of our biggest investors sent me this quote that said: don’t let success go to your head, but don’t let criticism go to your heart. Don’t let it go to your heart. Just shake it off. You’re doing the right thing. Keep your head down and keep showing progress.

Especially with investors, you have a real problem where because of the way that access to the public, because you have as a publicly traded company access to public markets. And we saw this with RobinHood and GameStop and all these kinds of things. You have a lot people in the market now who are trading. A lot of them are doing derivatives trading options. They don’t any comprehension whatsoever of you, your company, your product, anything at all. They’re just looking at technical data on the stock performance and trading on that. There’s a kind of abstract argument to be made that this is valuable for making sure that market stays efficient. But it’s not really something that is going to help your  company at all. And the flack from those people, it needs to be ignored and not just by you, but by everyone.

And I agree, and I think your point is right. It’s so important because when you look at the long-term opportunity to really deliver  shareholder return. I’ll  give you one example that, when you talked about being able to build a market, the interesting thing about this category is that if we were to just get two and a half percent, two and a half percent, that’s a billion dollar market opportunity. So for shareholders, it’s extraordinary, but they have to be patient. If you’re patient and wait. Like right now, we’re so undervalued that it’s a joke. But the point is that if you look at what our growth is now, and you look at that being compounded month after month, quarter after quarter, it’s amazing the impact that we can make for shareholders. But the tough thing is that you want people to listen to all that negative rhetoric because they get nervous.

I don’t know if this’ll help, but there’s no exceptions, right? It’s not just you. It’s everybody.

Yeah.

Every single company gets flack. Tesla gets more flack than  positive support from the same people. And there’s a noise there. It’s not signal. You gotta learn to ignore that.

I like that. I appreciate that sentiment.

If customers are saying this sucks for some reason or you heard investors were saying this sucks some for reason, that is signal, but it’s not signal, it is noise. And especially that those particular type of investors—they’re not really investors—they’re opportunistic folks who are trying to milk the market.

Yes. You’re right. It’s like a pump and dump kind of strategy. Women, I will tell you and our long-term health care investors know, not only do they know and recognize the opportunity for non-hormonal contraception, they also recognize the forthcoming to your point. We’re in this phase three study, we have top line data readout in the second quarter of next year. And we’re very excited about that. You know what I loved and I want to go back to is your comment that sometimes people make an investment. I’ve found that sometimes I meet , incredibly smart people, scientifically minded people, who have this great idea, but what they haven’t done is the market research.

Just because it’s a good idea doesn’t mean payers are going to cover it. It doesn’t mean you’re going to get investment for it. I meet some people and they have a great concept and they’ve gotten through phase one but they have no money. They don’t have way to differentiate themselves in the market. They don’t have any marketing opportunity to show investors. And here they are having spent all their money they had to get to this one point and they can’t get any further. And it’s heartbreaking. And one of the things we say is look just because there’s an unmet need, it doesn’t mean that the market’s going to bear it. It doesn’t mean that payers are going to cover it. And unfortunately, if you’re bringing a pharmaceutical product to market, you have to make sure that the insurers and payers are going cover it. Because if they’re not, you can’t get access.

And healthcare is so complex. 

So complex. Yes.

In my mind, any entrepreneur willing to work in healthcare or medical technology or about tech is a Saint just because you’re willing to try and innovate in a heavily regulated, very complex, big, old institutional environment. I couldn’t do it. I cheat and I go where there’s no regulation make a big mess and then set it on fire and bail out.

You are smart. Smarter than I. I have to tell you the truth, it is sometimes like a torture chamber. I’ll give you an example. And this isn’t Don’t Cry for Me Argentina.

There’s a reason to do it, which is that we’re trying to take your scar tissue and help the next generation of entrepreneurs and people who are trying to make a difference. Look, there’s very few people who can learn from their own mistakes. And then it’s like a subset of them who can learn from other people’s mistakes, but they’re the ones who are going get furthest and that’s who we’re trying to help out here. So, let’s get to the story. It’s not to cry for you. 

No. But what I meant was is when sometimes when I talk about our story, sometimes depending on the audience and in the right moment, one the reasons I’m so passionate is I spent my whole career on women’s health, literally. And my whole career when I say that, looking at the mindset, doing quantitative and qualitative market research, puberty through menopause. So when women do want to get pregnant, when they don’t want to get pregnant, when they want to space their pregnancies. And so really what are the levers? What do women really care about? But then a few years ago, I shockingly was diagnosed with late stage cancer. And when I was diagnosed, I had no family history. I had no genetic predisposition and I had a clean mammogram the year before. So for me, what was so shocking was that howI have all those positive factors and end up having aggressive late stage breast cancer and have to have a double mastectomy three weeks after my diagnosis start chemo. I had to my uterus removed and my ovaries removed.

Wait, they’re not in your breasts. How does that work?

Because they wanted me to get rid of everything that was going to increase estrogen. Everything because my cancer was estrogen positive breast cancer. So they said we need to kill a fly with a sledgehammer because your form of cancer is so aggressive. And then they said the only thing that we can really point to frankly, is that you have used hormonal birth control for 20 years.

Wow.

But here is where we talk about the regulation of this, right? I was on a podcast months and months ago. It was a very provocative broadcast. and they were talking about sexuality and intimacy and couples and it was a man and wife and I joked that chose to not have reconstruction so I look like Edward Scissorhands. So then I talked my own journey, just mine, but one of our competitors turned in the interview and said that I was suggesting that any woman who took any hormone was going to get cancer. And I was trying to scare women, it was outside of regulations, and I was doing off-label promotion and we got in trouble. And all I said was, this is my reality. This is my truth. It happened. It’s real. I didn’t have any of those factors and I ended up with cancer. Okay, that scares the hell out of you. And I said, look, if I had a daughter, which I don’t I have a son, but if I did, I would never let her use her mobile contraception. Not because we have a long family history because we didn’t, and I still ended up with cancer. That’s no joke. And so why this regulation is that any little thing you say in any little nuance and why they make us of those little disclaimers at the beginning is because the FDA wants to just make sure that it’s regulated but the one thing that I think is a bit of a bummer is my story.

Yeah, of course.

Right? It is.

That’s not FDA jurisdiction.

Right. Exactly.

I get it. You’re not the one who said that it was possibly hormonal birth control it caused the cancer.

Correct.

You had a medical professional who’s suggesting that possibility or at least the highest probability thing they know of. And yeah we don’t know for sure or when you were going to know for sure, but regardless it can’t be hard for any woman come up with a reason to not want to externally modify their hormonal balance all the time. There might be times you want to do it on purpose for a reason. But anyway, so look, you’re on the right track with the product. That’s awesome. How did you end up at Evofem? What were you doing?

Oh, wow. I be too verbose. At least I say sometimes what you choose chooses you. So I honestly mean this. I don’t know what Anchorage what was like, but where I grew up women really didn’t think they had a lot of choices and they really thought their choices was who they married or how many kids they had. My mother and all her friends, all felt like they were martyrs, that they have an opportunity to really be empowered. It wasn’t a thing yet. So I had all this in my subconscious. So when I left, my mother said to me, when you leave here you should not come back. And if you want me to visit you, you should send me a plane ticket. And we’d never been on a plane. We didn’t have enough money to go on a plane. I’m sitting at her like what? Honestly when I was growing up, she taught me no domestic skills. She said, you don’t need that. Cooking and cleaning is never going to get you out of here. Who cares about that? And I left and I thought wow. So my point is that my job out of college was in pharmaceuticals for a women’s healthcare company. And I started out as rep calling on  doctors. So the one great thing about being the CEO is not only do I know the drill. The reps that for us are pretty extraordinary humans. And they like me and I like them.

And one of the reasons they like me is that I know what the hell I’m talking about. I’m not somebody who is just a scientist who’s never been in the field. I lived and died by going out and talking about a product and how it worked. And I sold a variety of different products. Anyway, I did every job. I was a rep. I was a manager. I took over a region that was last in the country and turned it around. I was in marketing in the US and marketing internationally.

And so long story short, I spent most of my time running a global franchise. And that’s when I got my bug for what are we going to do for this vulnerable? Women that are outside of the United States. It forever changes you. So, I ran this franchise where we launched brands outside of the US where we went in to say what are the right products to launch in these markets because of socioeconomics and religious belief systems. And what changed me when I went, there was my ignorance. I had all of crazy ideas about what people wanted and thought there. And it was so insane. I literally was so foolish. I thought like they had pharmacies they could go to to get pads and tampons.

I’m only smart and Silicon valley everywhere else in the world. I’m completely idiotic. That’s what’s amazing about traveling and learning.

So I was so humbled and ashamed. I was humbled and ashamed and I thought, God I’m like silver spoon fed. I was still like oh my God I’m just so privileged. And it was extraordinary.

What part of the world had you gone to?

So most these experiences were in Kenya.

And South Africa, okay.

And I went to urban rural villages. I talked to the ministry of heath. I talked to distributors. But I also spent a lot of time in one of the largest slums called Kibera. There’s 600,000 people in the size of central park. And it was extraordinary to see that women are so desperate to not have children that they can’t feed and clothes and educate. They will do anything. They will walk two days to get access to contraception. And sometimes they’re not even real. It sugar pills, because there’s so much corruption that’s happening. But the one thing that I thought was amazing is that even these women, would literally, want the same thing as women in Beverly Hills, or Kentucky or New York City. They want a better life for their kids. And they don’t want five or six kids they can’t take care of. So the global footprint matters to me because once we are able to obtain the prevention of chlamydia and gonorrhea, this product I think is going to be very significant for us.

Because maybe like aid money could be used?

Yes. When these women have side effects from hormonal contraception, some of them think that they shouldn’t be using it anyway and these side effects are a way of punishment, right? If they don’t have information or education on how their body works.

American women don’t know!

I’m not kidding. A lot of American don’t know. Sex education  isn’t even really taught anymore in the school system. We don’t know our bodies and how they work. There’s so many myths and misconceptions. As an aside and not to go down a rabbit hole, but our Chief Medical Officer, who’s an OBGYN, Kelly Caldwell. She is doing this series called #UnpHiltered. So pH filtered for Phexxi. And it’s really educating women about their bodies and how they work. And it’s super cool and funny. And she’s very approachable.

Good. What is it on? online?

So right now it’s on Instagram, but we’re going to be putting it on Youtube next month. UnpHiltered with a pH.

On Instagram. Get on it people!

But anyway, the global foot print matters. And I have to tell you that innovation, when we talk about innovation, why I cared so much about talking to you today, is that innovation in women’s healthcare is not only necessary, but it will positively impact. Think about how they care about global warming? Think about how they care about clean water. How they care about education. More bodies the planet by choice, not chance. Choice, not chance. Less bodies on the planet that are unwanted, unplanned, and unwanted pregnancies come on! I have to be candid, I am a huge proponent of contraception that women will use, right? Why not? This isn’t about population control. This is about choice, not chance. Sometimes, I’m unpopular at dinner party. And I’m never really invited. Not that I ever been to any dinner parties. But I say things like look at some of these countries where rape is a weapon of war. It’s not a matter of if it’s when and how often. Okay. That’s no joke.

It’s worse than that. This is what gets me kicked out at dinner parties. If you just look back in history like most of the sex for women was nonconsensual 100%. It’s a fairly modern notion that women should have any say at all. And we definitely have some work to do to get the rest of the way where women have as much say as they really should have. There’s a lot of, a lot to overcome. And in the west, we’ve had a chance to make some progress on that. That’s not necessarily true everywhere in the world. And so there’s a lot of work.

I love that you said that because I will tell you this too. One of the underpinnings of this launch, and this brand, and this company is empowerment. And not just by the way for women. The one thing that I really honestly care a lot about. So I’m a single parent of a 13 year old boy. I say, hopefully I’m raising a feminist and a gentleman. I also joke that he’s either going to run the mob or be president.

Hopefully the former. So much more legit and fine upstanding citizens.

Why I say that is that even with the predisposed ideas to little boys like man up and be a man and grow up. All these ideas that take out their kindness, and their emotional capacity. There’s so many good men out there that want to support women, that loved their mothers and loved their daughters and loved their spouses. And I think that sometimes what people mistake about me as a woman and a human and about us, is that oh feminism is about man-hating and wanting to castrate men. Not only is it not about that, I think they are extraordinary dads that say, I want to know the conversation with my daughter, because I my daughter to have access to the right healthcare. And I want her to be empowered and I don’t want her to put hormones in her body. And I want her to know how her body works. But what I love is that there’s more people being willing to have that as dinner conversations. Why does it have to be so taboo? Why is it dirty? Why is it a dirty little secret? Why can’t we talk about your menses and your periods and why is that off topic? Because everybody has it. Everybody does.

We do it just like after dinner?

Yes. We can do it after dinner.

Look, I think it’s great that you’re claiming this for women, but I feel a little slighted this doesn’t feel women’s biotech. It feels like something I want too. I was like why is this for women? This is all the things I want are in this product. Men should want this.

Yes, men should want it because they could have this and if their partner doesn’t have one, they can say, look I’ve got a Phexxi.

If you’re a guy, and you someday get a girlfriend, she’s probably going to get on the pill if she’s not already. And she’s probably gonna have a whole bunch of problems you don’t want to deal with she’s on the pill. So just short circuit that. Help her so she doesn’t have get on the pill, get yourself fixed and also get her on Phexxi. That’s like A. Plan B is get a boyfriend and condoms.

It’s true! Honestly, we have investor who honest to goodness, his significant other reached out to me and she said, I have not felt like myself in a year. And she said when he said to me, you should go off of this because not only do I think you’re not yourself, but you don’t think you’re yourself. Come on. And she said that she would all of a sudden cry for no reason.

And also pointed out that nobody gets on a pill and it gets, becomes a better version of themselves because of it. That’s not one of the options. So I really I’m thrilled about that. I look at this product, the ingredients list, just so you guys know. Lactic acid, which is in like milk. Citric acid, which is in like red bull and lemonade, and potassium tartrate.

All of these ingredients are food grade.

It’s a food grade ingredients. Why does this why can’t this be over the counter? How could it go wrong?What orifice could I shove this in to cause a real problem?

Let me tell you why it’s prescription. So we in combination with the FDA, that where to chose prescription is a few reasons. 1) Under the Affordable Care Act, one product in each category of contraception is covered so women don’t have out of pocket pay. So it’s cheaper for women to get access under the affordable care act then to make it over the counter. 2) also in market research the majority of women said, even though, yes, there’s over the counter products. But said if a product is FDA approved and they’re doing something as serious as from getting pregnant. So that was why we knew that we wanted to further the chlamydia and gonorrhea. And so getting it approved first as hormonal contraceptive was a very smart and quick way to do that. So that’s why. Down the road though and in the future, yes.

Okay. All right. So then the plan for getting this to the rest of the world?

So the plan is this. So we actually got an investment from a group called Adjuvant Capital. So that investment was to lower the cost of goods. And that investment was to look at going into emerging markets. So we’re looking at three-five countries a year over a five-year period. So we’re literally working on that right now. We have a joint steering committee to say two things. Where are places where we access quickly? So can show success. And where are the places where it’s most needed? Which sometimes isn’t quickest. So not just quick wins, but a few quick wins so that we can get feedback to provide that feedback to some of the places to convince them you should help us get this approved.

How hard is it to get approved? Especially once you get FDA clearance?

Some countries will accept the application, but other countries make it much more challenging. And but we are looking at all of those factors, but the intention is to 100% ticket globally, but there’s also some countries that want license it. There’s a lot of partners in Asia that want to give us an upfront payment to license it, which would be great because it’d be non-dilutive capital coming into the company with milestones and royalties. So we’re actively talking partners literally right now.

So that’s a good of investor for you.

Very much.

Might be a licensee?

Correct.

Might be a regional licensee?

Yep.

Asia? The Middle East? 

Latin America. Because Latina women they are one  of the mindsets that some of the donors said to us about women in Africa is that they thought that women in Africa didn’t want to touch themselves vaginally. Putting an applicator and touching their vagina was considered taboo. When we went (meaning me and my chief medical officer,) to do a proof of concept. And we only went to Kenya and South Africa, but we actually found that to be contrary to the truth. These women said to us very directly  that they are being told by their male partner, to your point of not having consent, that they must use a lubricant for the pleasure of the man. And they’re already using lubricant for the pleasure of the man. And I will tell you these women, it didn’t take them very long to figure out that they could say oh this is just a lubricant. They didn’t have to put in the part that, oh maybe I won’t have your fifth child or eighth child because you think that you have a virility is measured by procreation.

In your experience, is there a lot of pressure to keep having kids? 

Oh my goodness. Yes.

So yeah. One of the things that I think people often don’t realize is the way progression has gone. You look at what we Western societies largely like Northern society, right? It’s north of the equator, it’s Europe and United States and some extent Russia and those things. This is all the countries that got rich early basically. And we’re all past our midlife crisis now. And we’re in the  past the prime of our lives in some sense. And the future is all south of the equator. It’s South America, it’s India, it’s Africa, it’s places in Southeast Asia and other parts of Asia. With the possible exception of Australia, it’s all south of the equator and what’s happening if you look in those regions is they are late to the urbanization game, but they’re urbanizing at extraordinary rates. And what happens is when you move to a more urban environment, kids flip from being an asset, working on the farm to a liability, go to private school, right? So now these are costing you. They’re not paying for their keep. And so you start having less kids, you get better educational opportunity to get better economic opportunity, which a lot of times why he got there in the first place. And so this is why the population for humans doesn’t just continue to grow exponentially because urbanization basically curves it. And so urbanization is the most efficient way the farm humans basically. So it’s important and these are good trends in some sense, but there’s a lot of growing pains and some things that we have to get through. And I think that especially you see, like in South America even with your urbanization, they’ve been a little bit slow to recognize the economic change means you can have fewer kids now and it’s okay, but cause they still have that in their minds. And I think it’s hurting a lot of women like you said.

It’s hurting a lot of women. It really is. And I will tell you that women, if they’re given access to the right choices, they will make them. They will. And that whole point and that women really are the center of these family units. Making, doing everything. And bringing in income as well, oftentimes.And so that’s, what’s so critical is that, so we’re really trying to really be the company. So our blind to science with a soul, and that’s not bullshit science where the soul, meaning that we really care It’s such a meaningful way that women recognize that we’re the kind of company that knows not only are they worth it, they deserve to be empowered with it on demand. So back your choice, I want to say this is that when you, just said, I loved about your statement is that we’re really just now coming into the age of real consent. So the idea that women should have pleasurable stuff. right? Oh my goodness. What a concept? My gosh.

I’ve been advocating for that person.

I bet you have.

There’s only so much I can do.

I’m telling you this. I have been so passionate about that I said, because you know, the whole adage, right? A guy who has sex with a lot of partners. Oh, he’s a Romeo at gigolo and a woman’s a slot, and not about that. about women being able to have control and empowerment have effects in their pocket or the breast. They know they can go out, they can have on demand, they can protect themselves. And they’ve got this, got this women are more empowered and more in tune with their bodies now than they’ve ever been. In my opinion. And particularly young women. Oh my I’ve had so many groups of young college girls and they have said to me, I’m not kidding. They’re like we are going to do a case study and a project on this brand. We are going to start talking about what that has made me. You don’t even know like an orgasm, frankly. These young women in there, and they’re smart, they’re capable and they’re driven. And they’re like, look, we are in control and empowered over our bodies. And we’re not in patriarchal mindset that we just do what we’re told no, that we don’t want to do this and put a synthetic hormone in our body. they. the idea of sex on demand. fact that it’s lubricating. So I said to a group of them, I said, it’s also discreet. You can go into the bathroom and you can put it in very and throw away the you know what they said? They said, are you kidding? We use this as part of intimacy, we have our partner play for us. And I was like, wow, good for you. And they joked and they said with the lights on and I’m like, even better.

You need like doctors to go on like tours of sororities and

Yes, this whole archaic mindset. Like come on! These girls can depend on themselves. Like they are in charge. That’s what I love. It’s awesome.

And even, I think, probably it’s important to say that it’s not that necessarily that they should make that same choice, but that they should be able to make that same choice.

Without question.

And I think especially when you look in other cultures where it’s going to be a little bit more of a cultural change for them.

Yes.

The story might have to be framed in a way that accommodates their belief system, which isn’t necessarily where we’re at.

No, I’ll tell you a provocative thing. And this is way down a rabbit hole.  But so we are very passionate about getting our own category at the Office on Women’s Health. And when I say that, why that matters is that with our own category, we’re the only product like this. So once they give us our own category, payers have to cover this so women will have access. However, one of the things that I talked about strategically is we’re even the kind of product that we could get perhaps religious organizations and even people who are on the other side of the aisle  because this does not impact a woman’s natural body. There’s no systemic effects. This is the way of a woman’s body, God given. So for some people they think that might be a bridge too far.

They’re having to revisit these notions anyway. It’s very difficult for religions to keep up the no contraception stance. The stance that’s against contraception has been pretty difficult to maintain even in very conservative societies and I could see that

Being a benefit,  if needed. The one wonderful thing is that having something like this that doesn’t have synthetic hormones. There’s an opportunity to do a paradigm shift. and change the conversation with people who otherwise were complete resistors to it. And so that’s what we’re really trying to do in hopes that frankly, we start softening some of these, very narrow-minded views about giving women the choice.

Just having the choice is what it’s really about. And innovation is about choices. Innovation and evolution is about coming out with new and better ways for us to evolve as humans. For us to procreate. For us to feel better. For our connected relationships to feel better. And so that’s the other thing too is that it’s sexual pleasure, connectivity, lack of side effects, all of those things, that create connection. So that’s why this innovation I think, is so important because it’s not just about the prevention  of pregnancy. Like fear-based, you don’t want to get pregnant. you don’t want to get pregnant. You don’t want to get raped. You don’t remember it. This is about pleasurable sex and feeling good about it.

And people that a really tough thing for a lot of people, not just women. But people in general, to be able get comfortable with sex, with a partner, exploring, getting over their hangups, anxieties, all the things that get in the way there’s so many things. And not even counting the possible STDs or pregnancy or any of these other things. And so it’s just really exciting to see a product like this could take that venn diagram of things that make it hard to line up with your partner. And just laugh off a whole bunch of things at once that to get in the way. How far along was this company when you came here?

The company had received a complete response letter by the FDA. The previous management and previous board had moved forward a study that had a lot of flaws and not a lot of agreement with the FDA. And the FDA said they weren’t going to approve the product. That was when I arrived. And I was told by the way, every  box was checked, this practice was so safe, nothing was going to happen. And it was a moment where you think to yourself oh my goodness, what have I done? What did I do? What did I do to deserve this? But I will tell you this, I  knew that this product was worth it. And I met with the investors and we then picked a different clinical research organization to do the confirmatory study. I brought in a whole new team of people. I separated from the parent company. I reconstituted this company in 2015 as standalone Evofem Biosciences. And we then we did this confirmatory study in agreement with the FDA. But yes, when I got here, the company was on fumes and just about ready to be shut down. And the thought that maybe they should just try to sell the asset for whatever they could get. And luckily, I think my women’s health care background convinced me that this was a diamond in the rough.

There’s like we see a lot and especially an innovation trying to do new things. And one of them is that the early team is maybe good at figuring out that the thing was possible in the first place, but their strengths aren’t in the perspective on what it would take to make it into a real product, the business, the regulatory environment, what it would take to sell the product, those kinds of things. And so they suffer a lot because they’re the people who are most invested in it. And I think this is one of the things that we’ve really done a poor job of coming from Silicon Valley is that we have kind of a mythical entrepreneur who is also an inventor and super technical and can do everything. That’s what we think these people are. And they’re really not like I know all of them.

Those people are very rare. And it doesn’t scale. And what I think is really what we have to start getting some ideas in our heads about the progression that are different. Your inventors are not your entrepreneurs necessarily. And you need to be able to transition,  something like this, a technology through those different life cycles, different stages of development. That’s why your first grade isn’t your college professor. You need different people at different stages. And so I think one of the things that actually makes me super optimistic and excited about this is seeing you here with your sales background and your knowledge of what it takes to get a product out that’s worth a  ton. I see the opposite so much, which there’s a big swinging dick scientist who left his professor role at the university, to be the CEO of company who has no clue about what it takes to actually make it a successful product and actually sell. And we said it’s all the time but the startups that fail, it’s almost never because they failed to make a product it’s because they failed to sell it.

Wow. Thank you. I find that true.

It’s worth so much and the so cool thing is that it’s only been the last 11 and a half months this product has been at the stage where it can take advantage of your strengths. I spent seven years doing the part you’re okay at to get to the part you’re good at. And so now you’re there. So it’s pretty exciting. And so you need some licensees, that’s one of you need.  I guess you need who are excited about this invest publicly. You’re listed as EVFM on the NASDAQ stock exchange. So you go buy the stock. I can say that you can’t probably can’t.

I appreciate it.

But don’t sell it, just buy it. And then, I guess it might also be cool if some other strategic investors who maybe wanted to help you bring it to other markets or maybe expanded more quickly in the US market. And then assuming all that goes few years, then you could go build the next thing.

Exactly.

Do you know what you want to do?

Yeah, I don’t.

The right answer though is shopping. Easier shopping instinct. Because you don’t need to invent a new thing. There’s thousands of things sitting with biotech entrepreneurs or founders don’t know what the hell they’re doing. And man it’s hard for them.

To tell you the real truth, if I had access to strategic investors really what I would do is I would go shopping and find all of these companies and do a roll up. These smart great  products that need sales and marketing expertise, which is what this company has. And we would do a roll up of five or six or seven products like literally 10, 15, 20, and start building and be the company that once they get through the concept phase that they take it to us and we can manifest it. It would be incredible to be the hub. It would be really extraordinary.

I think you should go for it. Yeah. That’s the hack. Because I can feed you an unlimited number of three person startups that have a killer tech. There’s so many, and it’s amazing. But I look at them and I said, okay guys you’re going to need an entrepreneur and a lot of stamina to get through FDA and all that stuff.

No, it’s true. It is a lot to get through that, but in the end it’s worth it. You know how that is. Phase one, phase two phase three, but yes now that we’re here at this point in journey, it’s what we’ve been waiting for so it’s really exciting.

Wow. Okay. I hope we can get you off, get you a turbo boost. 

I appreciate your interest. I do. And I love talking about innovation and I think it’s great. And I actually like the format to just talk about it all.

No, that’s the way to do it. People need to have real conversations. And I think some people never got to and some people forget what it’s like. So I’m just like, let’s have real conversations!

It’s freaky, some people cannot operate outside of a script. You know what I mean? They have the canned questions and by the way, no matter what you ask them, they’ll only give you canned answer.

The truth is even those people, I think they just don’t know. Like I can still, probably, maybe because my whole career has been hanging out with somewhat poorly socialized nerds. That’s normal to me. And I think they’ve been conditioned to believe they need a script and they believe that. And they’re nervous or whatever. But I think a lot of times you can get past that. At least I’m trying to do that. And I want to have real conversations with anybody and it shouldn’t matter whether what they’re into. Most people know about something. And if you talk to them about what they know about. And then, sometimes I don’t have to do it with you, but with some people I can try to translate it and make it more accessible. If it’s a super technical thing and get to the point where people can follow along and start to get their heads around it, because the natural instinct is to be terrified of things you don’t understand. And it turns out you can understand pretty much anything if you just hang in there for a bit.

I love that attitude and mindset. That’s great, but it’s true. You’re right. You can understand anything. You just have to have it positioned in a way. But yeah, that’s great.

Anything else you think people should know about?

I think we’ve covered it, honestly. Awesome.

Do you have any questions for me?

A million.

Yeah, we can do that.

I’d love that.

There are some interviews of me, but yeah. All right. We can do that next time. It’ll be our dinner party.

Okay, sounds good. I like that since we’re going to be thrown out of all the other different parties.

Awesome. Thanks so much. It’s really important. And I’m really excited about seeing what happens with you guys and hopefully it goes well from here.

Brilliant. Yeah, my pleasure.

All right. Thanks.

To learn more about Phexxi, speak to your healthcare provider and see full product information at Phexxi.com.  Do not use if you have a history of repeated urinary tract problems. Side effects include vaginal burning, itching, discharge, genital discomfort, yeast infection, urinary tract infection or bacterial vaginosis. Phexxi does not protect against STIs.

Important Links:

• Evofem Biosciences
• Phexxi
• Office on Women’s Health
• #UnpHiltered
• The Pill Helped Start the Sexual Revolution
• Rush University

About Saundra Pelletier

Saundra Pelletier is the Chief Executive Officer, President, and Executive Director of Evofem Biosciences. She leads an impressive team of passionate and highly skilled professionals committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health.

Recorded on May 5, 2021

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