Samantha Miller: Co-Founder & CEO of Cadence OTC

Episode 641

On this episode of The Kara Goldin Show, we’re joined by Samantha Miller, Co-Founder and CEO of Cadence OTC. Samantha is transforming reproductive healthcare by making over-the-counter contraceptives accessible to underserved communities. Through partnerships with convenience store giants like 7-Eleven, Cadence OTC ensures emergency contraception is available where it’s needed most. Samantha shares her journey, from leading over $3 billion in strategic deals to tackling FDA regulations and scaling a mission-driven company. We explore Cadence OTC’s impact on contraceptive deserts and its innovative approach to balancing affordability and accessibility.
If you care about healthcare innovation or building purpose-driven businesses, this episode is a must-listen. Tune in now on The Kara Goldin Show!

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Transcript

Kara Goldin 0:00
I am unwilling to give up that I will start over from scratch as many times as it takes to get where I want to be. I want to be you. Just want to make sure you will get knocked down. But just make sure you don’t get knocked out, knocked out. So your only choice should be go focus on what you can control. Control. Hi everyone, and welcome to the Kara Goldin show. Join me each week for inspiring conversations with some of the world’s greatest leaders. We’ll talk with founders, entrepreneurs, CEOs and really, some of the most interesting people of our time. Can’t wait to get started. Let’s go. Let’s go. Hi everyone, and welcome back to the Kara Goldin show. I’m super, super thrilled. And to welcome our next guest, Samantha Miller, who is the co founder and CEO of Cadence OTC. And if you’re not familiar with this company, you need to get familiar with the company. You’re going to be so excited to hear a lot more about this, and Samantha is an incredible entrepreneur. Cadence OTC is revolutionizing reproductive health care by making safe, effective and affordable over the counter contraceptives more accessible, especially in underserved communities. I love this. Through innovative partnerships with major convenience store chains, we’ll get a lot more into everything that Cadence OTC is doing, but Cadence OTC ensures that critical products like emergency contraception are available where they’re needed. So I can’t wait to dive into this and hear a lot more from Samantha. So welcome Samantha. How are you?

Samantha Miller 1:46
Thanks, Kara, doing great, and happy to be here and tell you more about what we’ve been up to. Super,

Kara Goldin 1:52
super excited. So Okay, first of all, how would you describe the company that you co founded, and you’re the CEO of Cadence OTC.

Samantha Miller 2:02
Well, the reason we the reason we call it OTC after Cadence, is that we are focused on over the counter products for reproductive health. You know, I spent my earlier career developing new technologies and innovative medicines. But what I’m doing here at Cadence is making sure that the the important products, the essential products that are already available, are really available and are really accessible in an equal, equitable way to to all women, because we’re focused on reproductive Health and men, of course.

Kara Goldin 2:40
So what’s the one moment that made you say, I have to go and start this company? You and I were chatting. We met when I was starting the company. I founded hint, way back in 2005 and you were not an entrepreneur at that point, so you decided to dive in and go and do this. But was there one moment, or multiple moments, when you were like, I have this idea. I need to go and do this

Samantha Miller 3:06
well for Cadence, the moment was that my two co founders are legends in family planning. They’re both obstetricians and professors and legends of public health. And they and and the senior co founder, the last thing he wanted to do in his life was bring the birth control pill over the counter. He had spent his entire life time trying to reduce unintended pregnancy and maternal mortality across the world. And he had always thought that having the most popular form of female contraception, the pill over the counter, would be essential to reducing unintended pregnancy, and the only way to do that was to form a small pharmaceutical company. So they were referred to me as somebody that can help them do that, as a small farm entrepreneur that had strong relationships with Big Pharma. And so they took me out for coffee, and they told me, and this was the moment they told me, that nearly half of all pregnancies in the United States today, at that time, were unintended, accidental, not intended pregnancies, and that kind of hit me like a ton of bricks. How could that be? I wouldn’t have ever guessed that. I didn’t know that. And the more I thought about it, the more consequential that came to me because, you know, single moms with accidental kids, unintended kids are kind of the the root of poverty in America and and the most important factor causing, you know, the continued. The suppression of women and all that we are and all that we can contribute. So that that was the moment, and I told them that. So what was needed to start the company is that in order to do a first in class RX OTC switch, which is basically bringing a medicine that’s only available by prescription to over the counter, you have to own the rights to a original prescription product. So you can’t do it with a generic product. You can’t do it with a new product. You have to acquire the rights, or own the rights, to an original prescription product with a long history of safety on the market, and the way to do that is, is through Big Pharma. And there was only at that time for companies on the globe that owned those rights for big pharma companies on the rights that we needed. I had a history of doing deals with Big Pharma, and so I told them that I would, that I would try, but it was unlikely, so I immediately, that night, actually came home and started contacting the people I knew in the right places, at those companies. Anyway, long story short, I was able to acquire the rights.

Kara Goldin 6:22
That’s amazing. And so it’s so there’s four players. What was the first step? Then, did you actually so you started reaching out to the four, and you you just had to get one of them to say, yes, yes.

Samantha Miller 6:36
However, you know, I had been dealing with big pharma for 20 years at that point, and I knew that they don’t do deals. They don’t sell the they don’t sell rights. They acquire rights. Frequently. They don’t sell rights unless it’s a, you know, 100 million dollar plus deal with another Big Pharma. So it’s very unusual for them to sell the rights to a commercial product to a small pharma like us. So however, I knew the people that were in the right places. Okay, so there’s a particular there’s a particular specialty within Big Pharma that does these types of deals, and I had been doing those types of deals, so I knew these people, and they would accept my call. They won’t even accept a call unless you’re in that club. So I was able to talk to them. Three out of four immediately said, Nothing. No way. It’s a non starter. But then Pfizer, at that time, opened the door. They had recently acquired the largest women’s health division. They acquired Wyeth. Used to be called the Wyeth Ayers. They had, they were a big pharma, they had the largest women’s health division, the largest contraceptive program, and when they acquired them, they acquired them for oncology products and biologicals. They didn’t acquire them for the women’s health products. And so they had recently done a strategic review and decided that they were not going to add women’s health to their portfolio of therapeutic areas. And so they were taking these products off the market, and they had been taken off the market and putting them on the shelf. And so for that reason, they decided that they would do a favor, and, you know, do the right thing and go ahead and sell those rights. So my timing was good, and I knew the right people, and they they called it weekend work, and explained that this will take a while, because, you know, we have permission from senior management, but we have to do it as weekend work, and we need, you know, regulatory resources, etc. So it took an it took a year to do this relatively simple deal for these two products, but they were ideal products. They’re the safest in the class and very popular birth control pills. So we closed that deal in 2016 and started the process.

Kara Goldin 9:30
That’s amazing. So you’re basically taking two prescription pills that you acquired into the over the counter market, so people do not need the prescription. So, so what was like, the next step, at that point, for you, and actually taking this company and making it into Cadence OTC?

Samantha Miller 9:53
So this is a very specialized process with FDA, highly collaborative. FDA requires consumer label development and many, many Consumer Studies, and it’s kind of this iterative process with these, you know, extensive input from FDA. So the first challenge was, we have to get the right team in place, and by the way, you actually have to start manufacturing the products too, and Pfizer was no longer manufacturing them, so that’s a whole nother challenge. So we had to get the right team in place and very, very specialized with the OTC switch process, and that, there were some stumbles along the way, but I used my network and developed to the right team, and then we proposed it to FDA, you know, 100 page briefing package explaining our rationale and our planned FDA. We had our first meeting at the end of 2016 and that was the beginning of this very extensive process.

Kara Goldin 11:03
So what were the biggest challenges in navigating the FDA approval process? Oh, boy, I get it. I get

Samantha Miller 11:13
it. Yeah, yeah. I mean, the FDA is very conservative about this type of first in class switch, because once you once we’re successful at getting our product over the counter, we then get three years of exclusivity on the over the counter market. And then after that, any birth control, any birth control pill in our class, and this is the main class of birth control pills. Can go ahead and copy what we’ve done and go over the counter. So generally, the whole class will go over the counter, you know, in less than 10 years. So they’re very conservative, very, very careful. So we needed to take all of the complex information that’s in the physician package insert, and we needed to communicate that to consumers in a way that they could understand. And we have the back of the box, and we have a booklet inside of the box, and then we have the box itself to communicate all of this information. And there are a couple contraindications or things. There are some people that have a reason to not use a regular birth control pill. So, so we, you know, so we’re writing this, we’re creating these consumer materials, and then we’re testing them on consumers, and then we’re changing them, we’re testing them, we’re changing them, we’re testing them, and then we’re sending them to FDA, and then FDA is changing them, and then we have to start over with consumers, and you know, it just goes back and forth. And then there’s very prescriptive studies that we have to do according to FDA protocols, with consumers to show their comprehension, to show that they’re making the right decisions if they if they are over 35 years old and smoke cigarettes, if they have a history of breast cancer. So this is it’s that that’s the elaborate process that we went through for years, and then we thought we had succeeded, because we had, we had incorporated all of the information that the FDA had had, had wanted and was in the physician information, and we had All of our materials were testing very well with consumers, and so we did what’s called pivotal studies, large statistical studies, and the outcome was really positive. And we were celebrating. We were excited. We submitted it to FDA, and I will never forget the moment in 2020, October of 2020, when we got during the pandemic, when we got the letter from FDA rejecting our results crazy, and this is after, you know, four years And just an enormous amount of investment of effort and money, rejected our results.

Kara Goldin 14:26
Crazy, yeah, and so what did you do at that point? You

Samantha Miller 14:31
know, at that point, we had to consider giving up, because how are we going to raise? You know, our investors are going to be so disappointed. And how will we raise more money?

Kara Goldin 14:44
Yeah, it was a crazy, crazy, crazy time, and so, so what did you do?

Samantha Miller 14:52
So, the the path forward? We had a we had some meetings with FDA. Um, the. The path forward was to take a different approach. Was to start over again, yeah, take a different approach, whereby we have a digital label. They wanted us to pursue a new initiative, a new FDA Initiative, where companies will use a tech, a technology assisted label, where someone goes through a QR code, or goes to a URL, and essentially takes a health questionnaire, and that a health questionnaire, and then at the end of this health questionnaire, the program tells you this product is right for you, or you should talk to your doctor because of X, Y or Z. And the process for developing this digital label, software development of this is heavily regulated as well, and therefore very complex and expensive, requiring enormous validation. And so we knew that to embark on that would be multiple years. Would be another four years, and would be more money than we had already spent. So that was what we were up against. So, you know, once we gathered all this information as to what is the path forward, what does it look like in terms of time and money, we presented that to our board. And, you know, we made a recommendation at that point to pursue it, even though we knew it was going to be very challenging to fund it. And we but we asked them, you need to decide they were all, you know, they were all our largest investors on our board, you need to decide. And the decision was, you know, as beaten down as we were, the decision was, let’s do it. Let’s do it, because nobody else is going to do it. I mean, this is our chance to get the birth control pillow or the counter. You know, this product has been available and used by, you know, hundreds of millions of women over more than 60 years. Um, it’s, it’s a safe product, it’s an effective product, and nobody else is doing it. So we decided to move forward and

Kara Goldin 17:38
And so today, you have partnerships with 711, Circle K. Can you talk a little bit about those like, what would the consumer Are you available nationwide in those C stores? Or tell me a little bit about how you show up?

Samantha Miller 17:54
Well, Kara, I need to clarify that our regular birth control pill, our combined birth control pill for daily use is not yet on the market. We are still working with FDA on this project. We are back. We are we have reached where we were in 2020, and we have developed our digital label. We have validated it. FDA has reviewed it multiple times. We have We are now in the middle of these pivotal studies. We finished our first pivotal study, very positive results. That was just finished a few months ago, and so we’re still in this process with FDA. In the meantime, of course, the Dobbs decision came down, and we had ideas about dramatically increasing access to the emergency contraceptive that was already over the counter, that already went through this first in class switch 15 years ago, and we decided that we would just go, that we would go forward with that, and if, if our idea could come to fruition. So the idea was this product, the emergency contraceptive, also called the morning after pill, is the progestin component of our regular birth control pill, our daily birth control pill, just at a higher dose. So this is a product that you need to take. It you need to take right after unprotected sex, and it can stop ovulation and prevent fertilization and prevent pregnancy. So this is not the abortion pill. This is a preventative but it has to happen quickly. So what we had realized from studying this market is that that this product was being was in a monopoly with the. Plan B Company and the plan B Family of Brands had more than 98% market share, and they were really only available in the large pharmacy stores, and that there was and that there’s about 20 million women of reproductive age that live in zip codes where it’s hard to find, and these are women that live in low income areas, in rural, small towns where they don’t have a Walgreens or CVS, and this product, they either can’t find it, or it’s very, very hard to find. And so we decided that we could get it to these neighborhoods if we could get convenience stores to carry it now, there’s no good reason for convenience stores to not carry it, because they’re already carrying five, you know, different condoms and so, why shouldn’t they carry it? This is an extremely safe product. It’s one pill. It’s got a four year shelf life. Why not it? You know, it’s it weighs nothing to ship around so and hours matter. So we went to there’s only one major distributor in the United States of healthcare products to the convenience store channel. And so we went to talk to them. Turns out that, you know, it’s owned by a woman. It the head of marketing is woman. The CEO is a man, and he was very, very supportive. So it took us a while to get them on board, but we also discovered that they’re a fantastic company, incredibly capable, ambitious, with an amazing network, so we partnered with them. We’ve been in exclusive partnership with them for over a year now, and the program is going very well. So we are overcoming this access issue with emergency contraceptives at the same time as we’re completing our process with FDA, which is now making very good progress. And

Kara Goldin 22:07
so at what point you have no idea, but like, what, like, what point will you actually, you’ve got the distribution in place now you’re just waiting for just that green light,

Samantha Miller 22:22
that’s right. So yeah. So we have now over 10,000 stores carrying our morning after pill and our pregnancy test today, and we will be expanding that to you know, our goal is to get to 100,000 stores by the time we launch Xena, which is our regular daily birth control pill. And you know, it’s we couple few years still to go on that.

Kara Goldin 22:56
That’s great and and what is the like? Do you feel like there’s certain retailers that it’s been very difficult for them to get their arms around this to date is, I mean, I would, I’m curious, like ones that actually have pharmacies, for example, do they feel like maybe this is a little competitive? I don’t know, like it’s I’m so curious what you’ve encountered. Stores

Samantha Miller 23:26
with pharmacies actually do not have an issue with carrying OTC products and the and the OTC birth control pill, because they actually make more money on OTCs, for the most part, because they don’t have to go through that pharmacy process, which is a bit expensive. So that’s not so much an issue with the emergency contraceptive. There are some stores and some small, smaller chains that are embarrassed to carry the product or even have a religious objection to carrying the product. So, you know, we try to educate that this is not an abortion pill, because they do conflate the morning after pill with the abortion pill. That’s a common misunderstanding. So we’re always educating about that and that it’s legal in all 50 states, because some people think it’s illegal in some states, and that you don’t need an ID or a age or a certain age to buy it. But yeah, we still have, we there. We still have, you know, regional chains that do not want to carry it, and the women have no way to get it.

Kara Goldin 24:46
And what about direct to consumer? Could you do? Could you go that route with your distribution? Or, I mean, I get more, I know it’s not OTC, but I get more Viagra commercials. Is past eight o’clock at night in my area, constantly showing and you know, it’s I’m so curious, like, if you could do that as well. We

Samantha Miller 25:11
do. We do have it available direct to consumer. You can go to our website to buy it. You can buy it on Amazon, and that’s great for people that want to have it in their cabinet, that want to be prepared in case they need it. And we like to tell men when you’re buying, you know, when you’re buying condoms, buy a morning after pill and just have it available. You know, as well as women, the the fact is, though, that most people, the vast majority of people buy it when they need it, when the condom broke or slipped off, or they missed their pills, or, you know, the myriad of reasons that you just need to have that backup. And so they buy it on emergency, and there you want to take it within 12 hours. So it’s labeled that you can take it up to 72 hours, but the efficacy declines literally hourly. The percentage probability of efficacy declines by the hour. And so we don’t if somebody is in that, in that urgent situation, we do not recommend buying it even through Amazon with 24 hour delivery. We recommend buying it in person at a store within 12 hours.

Kara Goldin 26:34
So what’s one piece of advice you’d give entrepreneurs who want to build businesses that solve real problems. I mean, I feel like you’re not just doing that. You’re also you’re, I mean, so much you’re doing something really hard, right? I mean, it’s, it’s it’s expensive, it’s hard, but I love your persistence and resilience, and you’re definitely sitting there waking up every day and building a puzzle that is incredibly, incredibly tough knowing what you know today. What would you say?

Samantha Miller 27:14
Well, one thing that we did that I think, was really helpful for the type of business that we have is we became a public benefits Corporation legally in Delaware. So this is not a B Corp certification. This is something different where you’re legally a public benefits company in Delaware, whereby investors all sign on to a charter that the social goals, the social impact goals, are equally important as the financial goals, and that has allowed us to, you know, we really have avoided traditional venture capital and have really gone towards really social impact investors who have very patient capital and are willing to go through this very hard process with us. And you know, at this point in time, we are seeing the light at the end of the tunnel. And you know, we probably would be suitable for more traditional investors at this point, but up until this point, it has been so important that all of our investors were passionate about increasing access to contraceptives, to those who need it most, and have been willing to go through, you know, these multiple hurdles with us. And I would consider that that avenue, if, if that’s the type of company you’re building,

Kara Goldin 28:50
so, so interesting. So what you’re doing with Cadence OTC, I think, is very admirable. I can’t wait to follow the success of this company and from tackling healthcare deserts to changing how we think about accessibility. Definitely, definitely, so much to think about here. And for everyone listening, definitely check out Cadence OTC website, Samantha, you are just a total rock star. So thank you for doing everything that you’re doing, and everyone needs to definitely check out the like I said, the website will have everything in the show notes, and good luck with everything so, so interesting.

Samantha Miller 29:37
Thank you so much for having me on your awesome show. Thank you so much.

Kara Goldin 29:41
Thanks again for listening to the Kara Goldin show. If you would please give us a review and feel free to share this podcast with others who would benefit and of course, feel free to subscribe so you don’t miss a single episode of our podcast. Just a reminder that I can be found on all platforms. At Kara Goldin, I would love to hear from you, too. So feel free to DM me, and if you want to hear more about my journey, I hope you will have a listen or pick up a copy of my Wall Street Journal, best selling book, undaunted, where I share more about my journey, including founding and building hint we are here every Monday, Wednesday and Friday. Thanks for listening, and goodbye for now. Bye.

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