Evofem Biosciences, Inc.

Thank you, and good afternoon, everyone. If you haven't done so already, I encourage you to access the slide 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, 2020.

With that, I'll turn the call over to Saundra Pelletier, Evofem CEO.

Thank you so much, Amy. Hello everyone.

Thank you for joining us this afternoon. In the second half of 2020 Evofem has achieved three significant milestones.

In September, we launched Phexxi, the first and only non-hormonal prescription contraceptive drugs for on-demand use. In October we closed the $25 million strategic investment from Adjuvant Capital.

And we initiated our pivotal Phase III trial of EVO100 for the prevention of chlamydia and the prevention of gonorrhea in women. On September 8, we announced the commercial launch of Phexxi 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 Phexxi, considering that there are 21 million women in the United States who are beyond hormones.

Phexxi 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 prescriptions 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 Phexxi. Our reported earnings represent only a small snapshot of our commercial launch, which is now only two months in and Russ Barrans, 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.

There are $25 million investment without a premium to the market on the date of close, as well as the 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 Evofem 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 EVO100 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 attest to the growing unmet need.

EVO100 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 are those adjectives relating, what do I really mean when I say superior? What I mean is that all of the people in our commercial organizations 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 said before, but I want to say it again, they have an average of eight years of women's health care experience and 15 years of pharma, their ability to call on longstanding relationships in the industry has provided invaluable resources, particularly now during the Phexxi 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 Phexxi 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. This 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 the same categories.

And the stories that we hear from them are unbelievably unique and different. And many of them say that they had never seen this kind of response from offices.

And these are people who would know better and they're no different. And we are sobering realist here, and we say, look, we don't 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 is very easy for them to see who these Phexxi patients are. So as turn the call over to Jay File, 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 Phexxi sales. Then Russ will talk in greater detail about the Phexxi 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?

Thank you, Saundra. For the three months ended September 30 2020, which included those first three weeks of Phexxi sales, we recognized 278,000 in net product sales.

This was from the initial stocking of Phexxi by wholesalers and specialty pharma customers adjusted for distributor fees, copays and other related items. Cost of goods sold was 317,000, which included 100,000 1x charge related to the product label.

Research and development costs decreased to 4.2 million in the third quarter of 2020. The decrease reflects an absence of costs for the Phexxi NDA and the AMPOWER trial in the current period.

This was partially offset by clinical trial expenses for EVOGUARD, which we initiated in October 2020 and higher payroll related expenses non-cash stock-based compensation due to increase again in the current period. Selling and marketing costs were 14.7 million in the third quarter of 2020 compared to 3.8 million for the third quarter of 2019.

We started breaking out this line item in 2020 in anticipation of the Phexxi launch, and for the prior year, reclassified 3.8 million from G&A into sales and marketing expense to conform with this presentation. The vast majority of the 10.9 million increase was related to the Phexxi launch.

General and administrative costs increased to 7.2 million in the third quarter of 2020, mainly reflecting an aggregate increase of 2.9 million over the prior year quarter associated with various operational items. As a result, total operating expenses were 26.4 million for the third quarter of 2020 as compared to 14.3 million in the prior year period.

Total other expense was 3.7 million in the third quarter of 2020 and maybe included a $3.1 billion cash change in fair value of the Baker Notes and 700,000 in accrued interest expense related to those notes. As a result, net loss attributable to common stockholders was 29.9 million, or loss of $0.37 per share for the quarter ended September 30, 2020, as compared with a net loss of 13.8 billion or $0.30 per share for the prior year period.

We closed the quarter with 86.7 million in unrestricted cash and as Saundra mentioned in October, we raised 25 million from Adjuvant Capital. This provides us with runway into the second half of 2021 based on current expense forecasts in cash firm and I want to highlight Phexxi revenue provides upside to this forecast.

With that, I'll turn it over to Russ.

Thank you, Jay. Phexxi is off to a strong start.

Right out of the gate healthcare providers started writing Phexxi prescriptions. In third quarter, which includes only the first three weeks of data, Phexxi was able to achieve 385 prescriptions, and we had our first refill before the quarter closed.

I look forward to sharing more robust data on our Q4 earnings call in March when we'll have a full quarter plus of data to share and to give us a better idea of the launch trajectory. Among the many early indicators of interest in Phexxi are two that I specifically want to highlight.

First, when you look at women who have entered through the Phexxi concierges experience and qualified as a candidate for Phexxi, 43% of these women booked an appointment through our telemedicine provider to discuss receiving a Phexxi prescription. The Phexxi concierges experience provider Populus Media have projected based on their experience and metrics from their prior launches, that the conversion rate would be 22%.

The Phexxi prescription conversion rate is double these projections. In fact, the Populus COOs noted that Phexxi is their most successful launch to-date, and that several thousands of women have come into the Phexxi experience in just the first eight weeks since launch.

Second, we're working with 83bar social media to specifically utilize their proprietary artificial intelligence to identify women who may be more interested in non-hormonal contraception in order to offer them an opportunity to learn more through a nurse support service before the Phexxi launch, the 83bar data metrics suggested they would be able to generate approximately 200 leads per month. Right from the beginning, they blew that number away with 200 in the first four days, they have consistently generated over 200 leads per week, four to five times higher than they anticipated since the beginning of this initiative.

Over 2300 leads have entered the Phexxi concierges experienced to-date through 83bar. Of all these women that they have reached out to, 30% have engaged with a 83bar regarding Phexxi approximately 75% of those highly qualified of these have spoken with one of the Phexxi support nurses and requested to see an HCP to determine a Phexxi prescription is right for them.

Another indicator of overall interest and awareness of Phexxi is the high volume of web site traffic at both our consumer and our healthcare provider websites for Phexxi. On the consumer side, www.phexxi.com, we are approaching nearly half a million visits since the launch on September 8, and weekly page visits consistently indicates that these women are not just entering on the landing page and leaving, they're finding out more information about Phexxi by visiting multiple pages.

And on the HCP site, we've had more than 31,000 unique visitors by the end of October. And again, each one visiting on average two pages, indicating that HCPs are seeking more information on the prescribing of Phexxi for their non-hormonal contraception candidates.

A great deal of interest has also been generated through social media influencers, particularly on Instagram. Now unlike typical celebrities, we are working with women who have followers identifying with them, we're more likely to be swayed to find out more information about Phexxi.

Among these Phexxi influencers are a woman named Becca Martinez with more than 660,000 followers that goes on The Bachelor and today she has two children and isn't sure if her and her husband are really ready for number three. Our followers tend to be exactly where her followers are in regards to attitudes and their stage of life.

Our influencers are equally influential with the other audiences that follow them. They periodically discuss their own contraceptive journey and they share stories about Phexxi with their followers.

Our influencers have 3.6 million followers in aggregate. With the biggest majority of these women are in our target audience for Phexxi.

Turning our focus to the salesforce efforts, our sales team has succeeded in detailing Phexxi to over two-thirds of our target HCP audience thus far. This underscores the caliber of the team we hired, good reps will find ways to see healthcare providers even in the midst of challenging times.

So while there has been roughly a 30% decline in offices that are willing to let salespeople enter into the office, based on the COVID-19 situation, we are getting creative in reaching our targets. For example, one of our teams in Florida brings an ice cream truck to the parking lot in front of the OB/GYN offices.

Everyone's able to leave the office come out to the truck for ice cream and while they're there, our representatives discuss Phexxi with the entire staff of HCPs and office personnel. Another really creative approach we've used is conducting outdoor virtual speaker programs.

We serve lunch to the attendees at distance tables of course with the speaker presented on a large wall of screen. These events are extremely well attended and they really result in very quick awareness of Phexxi.

As the weather turns colder in the north, trust me, our sales team will continue to find creative ways to gain access to HCPs. At Evofem, we are determined to be public proof and getting out the awareness of Phexxi.

Turning to market access. We currently have over 55% of commercial lives that are covered by Phexxi.

Our current coverage includes approximately 7 million lives that are covered at zero copay, zero deductible by prominent payers such as the United Health Care's of New York, Connecticut, Delaware, DC, Illinois, Maryland, Massachusetts, Oregon, Washington and California. It includes Kaiser of Washington State.

It includes Premera Blue Cross Blue Shield, Excellus, US Health Care Plan, Harvard Pilgrim Health Care, Fort Health Solutions, Geisinger Health, HealthNow Blue Cross Blue Shield of Western and Eastern New York. When you look at this level of coverage right out of the gate for women's health products, what this indicates is that payers recognize the uniqueness of Phexxi and the unmet need of the existing 21 million plus women who are beyond hormones.

We continue to work with the Office of Women's Health and the Health Resources and Services Administration or HRSA. To update their birth control tables to include Phexxi as a new birth control option with a unique mechanism of action as a vaginal pH modulator.

The timelines for decision are unpredictable. But we remain confident that Phexxi meets the threshold of a new MLA, ours has been recognized earlier by the pricing compendiums as well as these payers I've already mentioned from across the country.

I want to conclude with a look at the market opportunity for Phexxi. Among the millions of women in the United States who are at risk for pregnancy, and importantly, unintended pregnancy, there are three distinct segments we will target for Phexxi.

Our primary segments are first, women using no contraception at all. And also these women who are using non-prescription contraception such as barrier methods, withdraw or periodic abstinence.

Our second segment, or as some might say, later adopters are women who are currently using prescription contraception, but who may already be considering moving to a hormone free on-demand method. Phexxi's peak revenue potential is 1.4 to 2.3 billion by achieving only single-digit acquisition percentages of women in each of these three segments.

Based on our early indicators of a positive trend and our planned DTC campaign, which will be launched at the end of January, we are confident we can achieve Phexxi's full potential. With that, let me turn it over to Dr.

Kelly Culwell, our Chief Medical Officer.

Thank you, Russ. As Chief Medical Officer of Evofem, I am biased.

I am clearly a fan of Phexxi. But it's not because of my job.

It's not because I was an investigator in Phexxi clinical trial. It's because I am an OB/GYN who still sees patients granted only once or twice a month, but enough that I remain connected to the women that Evofem aims to serve.

I understand from a practical perspective who the Phexxi woman is, I have first-hand experience with women who do not want hormones and who will not use an IUD. I have seen their dissatisfaction leaving my office with a bag of condoms and frankly, as a provider, I was also dissatisfied with the lack of appropriate contraceptive choice before Phexxi.

The most effective contraceptive method is the one a woman will use consistently and correctly. This is not a marketing message.

This is reality. Women have access to a great deal of information and today more than ever, they are proactively driving the dialogue about contraception.

As an OB/GYN, it's not my place to tell a woman what to use. I help her to find the option that she will use.

I'm excited that health care providers like me can now offer women a new FDA approved hormone free on demand contraceptive method Phexxi. Turning to medical affairs, we continue to have great traction with our publication and presentation strategy.

We secured nine scientific presentations on datasets from AMPOWER, which was our Phase III contraception trial and on AMPREVENCE, which was our Phase IIb STI prevention study. At five key Medical Society meetings this fall.

For AMPOWER, this included poster presentations at the Society for Family Planning Annual Meeting 2020 where we were the sole sponsor of the Poster Hall, the nurse practitioners and women's health 23rd Annual women's Health Care Conference, the American Society for Reproductive Medicine 2020 Scientific Congress, and the American College of Obstetricians and Gynecologists Virtual Conference. AMPREVENCE's publications included an oral presentation at the American Society for Reproductive Medicine 2020 Scientific Congress on sexual satisfaction data in the trial.

Additionally, the full AMPREVENCE results were presented in a poster at the US CDC STD prevention conference and a poster on the impact of product adherence and condom use rates, on rates of urogenital reinfection with chlamydia and gonorrhea and AMPREVENCE were presented at the Society for Family Planning Annual Meeting 2020. Additionally, two abstracts on sexual satisfaction these trials were published in fertility and sterility and the full AMPOWER manuscript was published in contraception.

We aim to have the full AMPREVENCE manuscript published in the coming months and are working on submissions for spring conferences. On the clinical side, as Saundra mentioned, we initiated our pivotal Phase III trial for EVO100 for the prevention of chlamydia and gonorrhea in women.

This trial will enroll 1730 women at 90 U.S. study centers.

Specifically, we are enrolling women who have had and then successfully treated for urogenital chlamydia or gonorrhea infection at any time, over the 16 weeks prior to their enrollment visit and who have had one or more risk factors for infection. They will receive EVO100, or placebo with instructions to use study drug immediately before or within one hour before having sex for the four-month treatment period.

In terms of timing, we expect to complete enrollment by the end of 2021 and report top-line results in the first half of 2022 with an NDA submission plan for late 2022. Also, I want to remind everyone that EVO100 has been granted Fast Track designation for the prevention of chlamydia in women by the FDA, and is an FDA designated qualified infectious disease product for the prevention of gonorrhea in women.

So we would expect a priority review with a PDUFA date in mid-2023. And with that, operator, we'd like to open the call for questions.

Great, thanks so much. So I've had the opportunity to talk a lot about what we're doing and what we're doing in this virtual environment.

And outside of breathing, talking about Phexxi is my most favorite thing. And I really mean that.

And people have asked me, what are investors -- are they missing anything? And so, the one thing I want to share is that, we know that we have some amazing investors, and yes, they are mostly male dominant.

And these investors say to us, that they don't want their daughters to take hormonal birth control for 20 years, that they are worried about them suffering from side effects and not feeling like themselves. They say to us that they don't want the women in their lives to suffer from those kinds of side effects.

And they really want the women that they know that they talk to that they care about to feel as good as they possibly can while protecting themselves. So we actually feel that everybody now understands that it is time for a new option.

And once investors take the time to look under the hood, so to speak of Evofem, they really like what they see. The one thing I know to be true is that there are moments in time that change categories.

When, for example, the hormonal IUD came out Mirena, it was a moment in time when women were tired of taking a pill every day. They wanted a fit and forget method, that product was supposed to do 74 million and it does $1.4 billion today, that moment exists now, for Phexxi.

Women want a non-hormonal option; they want something that they only use when they need it and never when they don't. They are ready to be empowered, just like men have been for years.

And I know that I've said it before but I want to say it again, because the market is speaking to us and validating what we know to be true. That moment in time is happening again in this category.

And it's happening for non-hormonal and Evofem is here to deliver. The company is filled with people who are the very best in their class.

We've come together with a common mission to improve the lives of women by developing and commercializing real innovation. We have an approved asset in Phexxi.

And this is a surprising number to me, but only 14% of drugs that start the FDA process actually make it through FDA approval. So we're disrupting the market with a first-in-class hormone free product.

And we've just advanced our second asset in the pivotal Phase III three study for prevention of chlamydia and gonorrhea. And again, there are no approved drug products to prevent these STIs.

Our trial will build on the very highly positive, statistically significant results that we already shared from our Phase IIb clinical trials. So we feel we've proven our ability to deliver on clinical rigor.

We've proven our ability to raise capital when very few companies can bring in the money that they need. And we will prove that a Harvard Business School study should be written about how we successfully launched a product during a global pandemic.

Ultimately, in the end, women deserve more. Evofem is delivering and if that is not worth investing in.

I don't know what is. So thank you for your support and have a great rest of your day.