Evofem Biosciences, Inc.

THE END Ladies and gentlemen, thank you for standing by, and welcome to the ABLE-FEM Biosciences Third Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To participate in that portion of the call, you will need to press star 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star and zero. I will now hand the conference over to your speaker today, Amy Raskos, EvoFem Biosciences, Head of Investor Relations. Ma'am, please go ahead.

Thank you, and good afternoon, everyone. If you haven't done so already, I encourage you to access the slides which accompany today's call and the press release we issued earlier this afternoon, both of which are at evofem.com under the Investors tab. Before we begin, I would like to remind you that remarks on this call will contain forward-looking statements, which are made only as of today, November 9, 2020. For a more detailed description of important risk factors that could cause our actual results to differ materially, please refer to our annual report on Form 10-K, our most recently filed 10-Q, and our current report on Form 8-K, filed with the SEC on June 2 of 2020. With that, I'll turn the call over to Sandra Pelletier, FOM's CEO.

Thank you so much, Amy. Hello, everyone. Thank you for joining us this afternoon. In the second half of 2020, Avofem has achieved three significant milestones. In September, we launched Vexxy, the first and only non-hormonal prescription contraceptive drug for on-demand use. In October, we closed a $25 million strategic investment from Adjuvant Capital. And we initiated our pivotal phase three trial of EVO 100 for the prevention of chlamydia and the prevention of gonorrhea in women. On September 8th, we announced the commercial launch of Phexy. Despite the challenges we faced launching a commercial product in the midst of COVID-19, we are proud of our early momentum and we're confident about the long-term success of Phexy. Considering that there are 21 million women in the United States who are beyond hormones, FEXI has conservatively a billion-dollar market opportunity. In fact, so listen to this part. If we can just acquire 3% of these 21 million women, that's just 630,000 women out of the 21 million that are already beyond hormones, and they fill their prescription seven times in one year, we will achieve this potential. Once again, this illustrates that small percentages of market share will deliver very big results for FECSI. Our reported earnings represent only a small snapshot of our commercial launch, which is now only two months in. And Russ Behrens, our chief commercial officer, will discuss later on the call our early indicators that support a strong growth trajectory and gets us well above that conservative figure. Our extensive consumer brand awareness campaign has leveraged the targeted digital channels and key influencers to raise awareness of Phexxi with a diverse and engaged consumer audience. Our early adoption of telemedicine has provided women with expanded access to Phexxi without the need and without the hassle of a physician office visit. And we are especially proud of our team's ability to implement the Phexxi Concierge Experience, which is our comprehensive online experience for women seeking to gain access to contraception. In this business, an unwritten rule is that you take good capital when you get it, at the right cost and from the right party. For well over a year, we built a strong relationship with Adjuvant Capital. They are backed by the Bill and Melinda Gates Foundation and other global public health leaders like Merck and Novartis. Adjuvant is deeply aligned with our core mission, developing and commercializing innovative products to address critical sexual and reproductive health concerns of women. Their $25 million investment was at a premium to the market on the date of close, as well as a premium to the fundraising round we completed in June. This is Adjuvant's largest single investment to date. What is important is that what that testifies to is the confidence that they have in this team and the importance of introducing true innovation in women's health, not just Me Too products in crowded categories. For Ebofem, And for our shareholders, this was a very smart strategic move. The thing that I want investors to hear, though, that's very important is that the lion's share of the adjuvant investment is earmarked to fund the development of EVO 100 for the prevention of chlamydia and gonorrhea in women. We enrolled the first patient in our pivotal Phase III trial in mid-October, in line with our stated timeframe. And we met our enrollment target for the month of October in just nine days. So we are very confident that even in the COVID environment, we will not have any issues enrolling in this trial. There is nothing FDA approved for the prevention of chlamydia and gonorrhea, and every woman having sex is at potential risk. The reality is that partners are unpredictable, and that's sad, but it is true. And condoms break, and many times women don't win the condom negotiation, and therefore they're not even used. So the increasing prevalence of these STIs in the U.S. and globally attests to the growing unmet need. EVO 100 has the potential to be the first drug approved for the prevention of these common STIs, and many investors think this will be an even bigger opportunity for us than contraception. In addition to our drive for innovation, which as you have seen, is going to be threefold. First, with the only non-hormonal contraceptive product that women use on demand, Then with the prevention of chlamydia and gonorrhea, we continue to differentiate ourselves, and we're also differentiated by our culture, which enables us to attract, to grow, and to retain top talent at every level in every department. Investors have the confidence that we not only have a game-changing product, but we have a superior team to execute. So what do those adjectives really mean? What do I really mean when I say superior? What I mean is that all of the people in our commercial organization have surely worked on the biggest products in contraception, delivering very big results because they know how to maneuver through hurdles. They know and understand how to make these products rise to the top of the mind for both women and for doctors. Our sales team alone is second to none. As we've said before, but I want to say it again, they have an average of eight years of women's healthcare experience and 15 years of pharma. Their ability to call on long-standing relationships in the industry is has provided invaluable resources, particularly now during the FECSI launch, because there's many offices that are closed due to the pandemic. So I do want to tell you with full confidence, you will not find a better team to make FECSI a commercial success. We are an organization that inspects what we expect. We have very close, very consistent, and constant interaction with the payer teams and the commercial teams. Just Friday, we had an incredible call with the entire sales organization. The purpose was to share success stories, to talk about how to overcome obstacles, and to get feedback. And I want to tell you that these reps have launched not just one, not two, sometimes three, four, and five contraceptive products in these same categories. And the stories that we hear from them are unbelievably unique and different. And many of them say that they have never seen this kind of response from offices. And these are people who would know better, and they know different. And we are sobering realists here, and we say, look, we do not want to just know about the rainbows and the puppy dogs. We want to know about the warts. And so it's very encouraging to see that once these reps have an opportunity to talk to doctors and offices, it is very easy for them to see who these fexy patients are. So as I turn the call over to Jay Feil, our CFO, to review the results of the third quarter, I want to highlight that this includes our first-ever revenues which are from just the initial three weeks of the FEXI sales. Then Russ will talk in greater detail about the FEXI commercial launch and the early trends in the marketplace, which, frankly, are very positive. And Kelly Caldwell will give a clinical update, and then we will open the call for questions. So with that, Jay?