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Edited Transcript of EVFM earnings conference call or presentation 7-Nov-19 4:00pm GMT

Q3 2019 Evofem Biosciences Inc Earnings Call

SAN DIEGO Nov 19, 2019 (Thomson StreetEvents) -- Edited Transcript of Evofem Biosciences Inc earnings conference call or presentation Thursday, November 7, 2019 at 4:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Amy Raskopf

Evofem Biosciences, Inc. - Head of IR

* Saundra Pelletier

Evofem Biosciences, Inc. - CEO

* Jay File

Evofem Biosciences, Inc. - CFO

* Russ Barrans

Evofem Biosciences, Inc. - Chief Commercial Officer

* Kelly Culwell

Evofem Biosciences, Inc. - Chief Medical Officer

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Conference Call Participants

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* Ashley Ryu

RBC Capital Markets - Analyst

* Rachel Yang

ROTH Capital Partners - Analyst

* Louise Chen

Cantor Fitzgerald - Analyst

* Leland Gershell

Oppenheimer - Analyst

* Ram Selvaraju

H.C. Wainwright - Analyst

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Presentation

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Operator [1]

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Good morning and thank you for joining the Evofem Q3 financial results call. I will now turn the call over to Amy Raskopf.

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Amy Raskopf, Evofem Biosciences, Inc. - Head of IR [2]

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Thank you, Crystal. This is Amy Raskopf, Evofem Biosciences' Head of Investor Relations. Thank you for participating in today's call. If you haven't done so already, I encourage you to access the Q3 2019 presentation and the press release we issued after market yesterday, both of which are at Evofem.com under the Investors tab.

During this call management will make forward-looking statements regarding the Company's future expectations, plans and prospects that constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those expressed in or implied by these forward-looking statements as a result of various important factors, including those noted on slide 2 and described in the Company's SEC filings which are available at SEC.gov and in the Investors section of Evofem.com.

The forward-looking statements made during this call should be considered accurate only as of today, November 7, 2019. Although the Company may elect to update forward-looking statements from time to time in the future, we specifically disclaim any duty or obligation to do so even as new information becomes available or other events occur in the future. With that I'll turn the call over to Saundra Pelletier, Evofem's CEO.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [3]

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Thank you so much, Amy, and hello, everyone, and thank you for joining us. The indisputable truth is that in the United States today, millions of sexually active women are no longer using hormonal contraception. They are beyond hormones, because their journeys have been emotional, and they've been frustrating. There are dissatisfied with the options that are available to them, and they're eagerly awaiting a new alternative.

So, today we're excited to share some compelling new consumer research later in the call that will further define who we view as the Amphora woman. But first, I'm thrilled to provide you with an update on our progress this quarter as we prepare for our evolution from a clinical stage company to a commercial organization.

In the coming weeks we will deliver on three significant milestones that have the potential to transform the Evofem story. Number one, the resubmission of the Amphora NDA for the prevention of pregnancy to the FDA. Number two, reporting of top-line Amprevence results. And number three, acceleration of our pre-commercial activities and launch preparation.

Amphora is our lead Multipurpose Vaginal pH Regulator, or MVP-R candidate. This innovative, hormone-free, surfactant-free vaginal gel regulates vaginal pH in the normal 3.5 to 4.5 range. This maintains an acidic vaginal environment which is inhospitable to sperm and also to various bacterial pathogens.

our NDA includes data from the Phase 3 AMPOWER study which were presented last month at two significant medical society conferences: The American Society for Reproductive Medicine and the Nurse Practitioners in Women's Health. In this important study the primary endpoint was met, demonstrating efficacy of Amphora for the prevention of pregnancy.

We are confident that, based on the data and our productive dialogue with the FDA, that Amphora is an approvable assets. Already we are advancing pre-commercial activities to ensure that we are prepared for the potential FDA approval in the launch of Amphora in 2020 as the first-in-class, hormone-free, on-demand female-controlled contraceptive drug product in the United States.

We also look forward to unblinding and reporting our top-line results from the Amprevence trial evaluating Amphora for the prevention of chlamydia and gonorrhea later this month, which I will discuss later on this call, after our CFO, Jay File, who I will turn it over to now, reviews the third-quarter results. Jay?

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Jay File, Evofem Biosciences, Inc. - CFO [4]

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Thank you, Saundra, and good morning, everyone. For the three months ended September 30, 2019, total operating expenses decreased 22% to $14.3 million. Research and development costs decreased 43% to $5.7 million driven mainly by lower clinical trial costs reflecting completion of the clinical phase of the AMPOWER trial in the fourth quarter of last year.

General and administrative costs were relatively flat in the third quarter of 2019 to $8.6 million. There was a $1.1 million increase in pre-commercialization sales and marketing-related expenses, and a $1.2 million increase in payroll-related expenses due to increased headcount and recruiting and consulting services compared to the prior year period.

These aggregate increases were offset by a $2.4 million decrease in non-cash stock-based compensation mainly associated with restricted stock and stock-based awards granted in the prior year. As a result now loss attributable to common stockholders improved to $13.8 million or a net loss of $0.30 per share for the quarter ended September 30, 2019 compared with a net loss of $18.4 million or a loss of $0.71 per share for the prior year quarter.

We closed the third quarter with $35.8 million in unrestricted cash and short-term investments. We continue to expect our next two quarters' cash burn will be approximately $14 billion per quarter. Based on our current plans we believe that we have sufficient funding through the anticipated approval of Amphora. With that, I'll turn it back to Saundra.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [5]

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Thank you, Jay. As you know, our top priority is getting Amphora to the finish line. The team is working around the clock to finalize the incredibly detailed comprehensive data package that comprises the NDA resubmission for Amphora for the prevention of pregnancy. We remain on track to resubmit our NDA in the next few weeks and this keeps us on schedule for the approval and the launch of Amphora in the second quarter of 2020.

The reality is that birth control options need to be as diverse as the women who use them. One size does not fit all. Research suggests that there's a significant number of women who are beyond hormones. They are dissatisfied with the limitations of their current choices -- the copper IUD, condoms withdrawal, rhythm method, and frankly no method at all.

There is a stark need for a new non-hormonal contraceptive option. We are confident that, based on our extensive market research, that women and their healthcare providers will welcome and embrace Amphora for its unique proposition as a hormone-free female controlled birth control that's used in the moment.

Let's also not forget that in the AMPOWER trial Amphora not only comfortably met its efficacy endpoint and was well tolerated, but it also demonstrated an increase in sexual satisfaction. 45% of women who used Amphora for at least one cycle reported that their sex life was a little or a lot better compared to their previous contraceptive methods.

Now keep in mind when I say this that Amphora is not designed to be a libido enhancer. The fact that it both prevents pregnancy and is associated with an increase in sexual satisfaction makes it even more compelling as an option for women who say they are beyond hormones.

These findings are further supported by the patient satisfaction data that we collected from the AMPOWER study and we presented last month at ASRM, suggesting that more than 85% of women reported being satisfied or very satisfied with Amphora. This is nearly double the percentage reporting satisfaction with their baseline contraceptive method.

When you consider the unmet needs of millions of women who cannot or who will not use hormonal contraception, and you consider the favorable sexual and overall satisfaction data, it's very easy to see why we believe Amphora will be a commercial success.

An important part of our long-term strategy for Amphora is to explore additional indications that are beyond the prevention of pregnancy. While there are many opportunities for Amphora due to its ability to regulate vaginal pH, our initial focus is on the potential for the prevention of chlamydia, which is the most common reportable infectious disease in the US today.

In fact, the CDC highlighted last month that over 1.8 million cases of chlamydia were reported in 2018, making the fifth consecutive year of increased chlamydia rates in the US. And with no products approved for the prevention of chlamydia, the unmet need is very clear.

Our placebo-controlled Amprevence trial was conducted at 50 US study centers and enrolled 860 women who have been diagnosed and treated for chlamydia or gonorrhea in the preceding 16 weeks. These women have a 20% to 30% risk of reinfection in the subsequent 6 to 12 months. They were randomized to use either Amphora or a placebo vaginal gel for the duration of the four month interventional period.

This is the first time that there has been an in-human trial of Amphora for STI prevention. It builds on favorable in vitro kill time data, as well as animal data, showing Amphora's efficacy in preventing chlamydia and gonorrhea. We were allowed to move right into a Phase 2b trial due to the large body of data that demonstrates Amphora's safety in more than 2,500 women.

I'm pleased to confirm that we are on track to report top-line Amprevence data later this month. Although we don't yet have a view on the data, any clinically significant difference between Amphora and placebo would be a win because there is nothing currently indicated for the prevention of chlamydia. The Amprevence data will provide us with the information we need to plan the most efficient Phase 3 confirmatory study for the prevention of chlamydia.

We're excited about the potential for Amphora to address yet another unmet need. But let me be very clear, the near-term and largest commercial opportunity is establishing Amphora as the first-in-class, hormone-free, in-the-moment drug product in the US.

While we have not yet provided guidance on the potential launch trajectory for Amphora, what I can say is that the current market data continue to build the confidence and the enthusiasm of our team, people who have spent their entire careers in women's health and they can't wait for the opportunity to launch a disruptive new contraceptive option.

Now I'm going to ask our Chief Commercial Officer, Russ Barrans, to discuss the latest insights that we've gleaned about the US mindset and the US market. Russ?

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [6]

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Thank you, Saundra. As you know, we did commission extensive market research across multiple sectors and stakeholders to capture and define the market opportunity for Amphora and the insights we gained tell us this --.

First, Amphora has the potential to meet the needs of millions of women

who are at the greatest risk for an unintended pregnancy and not currently

satisfied in the contraceptive market.

Next, healthcare providers anticipate it would be the clear option in their armamentarium for women who are beyond hormones.

And finally, payers indicate that they will reimburse an Amphora prescription under the Affordable Care Act in the same way other monthly contraceptives are covered.

Previously we had discussed the target market for Amphora from an epidemiological perspective, leveraging data that comes from the Guttmacher Contraceptive Use Report. As we move closer to commercialization, we have been investing in more precise market research that further defines our target.

I'm pleased to share with you today some new results from an independent round of consumer segmentation research that we commissioned involving more than 3,000 women ages 18 to 44. This important research confirms the significant market opportunity for Amphora and further defines the population of women who will be critical to our commercial success.

When the research company extrapolated the findings to the approximately 45 million women who are candidates for contraception, the research identified 17 million women who, because of their dissatisfaction with current birth-control or their interest in seeking out non-hormonal options, fit the Amphora profile. They are, as Saundra has said, beyond hormones.

Of these women, 8.9 million, or nearly 9 million, are actively in search of new options. They are, as we would say, the early adopters. They are information seekers. They take charge of their own health and we know that they are actively looking for non-hormonal options.

There's an additional 8 million women who either aren't regularly using birth control, but would be interested in a hormone-free on-demand method, or who are currently dissatisfied with their birth control and, again, would be interested in an alternative non-hormonal option.

The main difference between these two groups or segments is simply the speed of adoption. Think of it this way -- the first group are the ones who are standing in line for the latest version of the iPhone.

I should point out that this research does not include the potential impact of the planned Amphora label expansion to include the prevention of chlamydia. Our prior research suggests even greater interest should Amphora be approved for this secondary indication.

So in summary, these data are incredibly compelling to us as they validate the significant market opportunity for Amphora as suggested by the Guttmacher Report and puts a fine point on what women value and want from their contraception. There is a clear desire among more than 17 million women for new non-hormonal free options that provide total control over when, where and how they engage in sexual activity.

I wanted also to share with you a brief update on our pre-commercial activities which are accelerating in anticipation of the resubmission and potential FDA approval mid-next year. This includes the plans to hire a first-class sales team of 125 representatives. The team will be hired with deep experience in contraception and reproductive health. The momentum is building and we are very excited about our third-quarter progress and pending fourth-quarter milestones.

I'll look forward to providing an update on our commercial build out during our next quarterly call in February. With that, operator, please open the call to questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions). Randall Stanicky, RBC Capital Markets.

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Ashley Ryu, RBC Capital Markets - Analyst [2]

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Hi, good morning. This is Ashley Ryu on for Randall. So, a contraceptive patch had its AdCom recently with kind of a positive vote around the risk-benefit profile supporting approval. I know it would still be obviously a long way out, but can you just talk about your expectations around whether you think you would need an AdCom and also whether you see kind of read through from their meeting to Amphora?

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [3]

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Yes, Kelly Culwell, our Chief Medical Officer, I'm going to ask her to start (inaudible).

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Kelly Culwell, Evofem Biosciences, Inc. - Chief Medical Officer [4]

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Yes. Hi, thank you for the question. We don't anticipate that the FDA will convene an AdCom for Amphora based on the fact that we have very clear efficacy and safety results. We met our predefined primary endpoint for efficacy. Our safety profile was demonstrated in over 19,000 cycles of exposure, and we have had an ongoing, very productive dialogue with the agency throughout the process of both planning our confirmatory Phase 3 trial and subsequently in our pre-NDA meeting that we had in April of this year.

We were though very encouraged by the fact that there was a large sort of groundswell for the need for more contraceptive options during the AdCom, and the majority of reviewers mentioned this as one of their key reasons for recommending approval. And we agree with them 100%. So, we look forward to being able to launch Amphora to add to those contraceptive options as a hormone-free option in 2020.

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Ashley Ryu, RBC Capital Markets - Analyst [5]

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Great thanks. And just one follow-up. What's your expectation around the timing of an end of Phase 2 meeting with FDA for the STIs? And I think you mentioned earlier in the script that this could be kind of one of two pivotal trials. Could you just kind of talk us through what you are expecting around the design of the trial, enrollment and such? Thank you.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [6]

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Sure, absolutely. Thank you. So we do intend to have an end of Phase 2 meeting in the early part of 2020, so probably in the first quarter or early second quarter. We will also be presenting to the agency at that time our plans for our confirmatory Phase 3 trial. And as you noted, should our Amprevence trial hit its primary endpoint, then we have been in discussions with the agency that that would be one of two pivotal trials. So, we would just need to do a second confirmatory Phase 3 trial.

That trial will be similar to our Phase 2b trial. It may be a little larger because we are planning to expand the enrollment criteria to include all women at risk for chlamydia and gonorrhea, not just women with a recent infection. And so, that may -- that would lower the baseline risk for infection.

However, we will have all of the information that we've gained from the Phase 2b trial which will allow us to be much more precise in our sample size calculations. And so, it may be that we may not need to have as large a trial as we would otherwise just given the fact that we will have such a body of data to be able to base our assumptions on from the Phase 2b trial.

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Ashley Ryu, RBC Capital Markets - Analyst [7]

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Got it. Thank you so much.

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Operator [8]

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Yasmeen Rahimi, ROTH Capital Partners.

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Rachel Yang, ROTH Capital Partners - Analyst [9]

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So first, can you tell us how the data looks when you combine the first Phase 3 and the second Phase 3 AMPOWER together? How much alignment do you see in perfect use and typical use? And how representative is the patient population when put together across both versus the real world? And how does the safety and dropout compare when you put the two data sets together? Thank you.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [10]

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Sure, thanks for the question. So to start, our efficacy for the approval of the product is based solely on our second Phase 3 trial. So, the efficacy results that we have previously reported are the efficacy results that are going in for the approval.

The safety profile is going to include both of the Phase 3 trials and the safety profile is incredibly similar across both trials. And as noted before, we have more than 19,000 cycles of exposure between the two studies. So, a very extensive safety database, again, less than 2% of women discontinuing the trial due to any adverse events, around 1% serious adverse events raised, none of which were deemed definitively related to the product's use, and that was consistent across both trials.

The patient demographics also very consistent and also very consistent with the US population. I would say the only difference between the two trials is in the second trial we did have more Hispanic population that was actually -- but again, very -- because the first trial was done between 2011 and 2014. Our trial, the AMPOWER trial that was done, having a slightly higher Hispanic population is consistent with the demographics of the US population between then and now.

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Rachel Yang, ROTH Capital Partners - Analyst [11]

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Great. Very helpful. Thank you so much.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [12]

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Sure.

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Operator [13]

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Louise Chen, Cantor Fitzgerald.

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Louise Chen, Cantor Fitzgerald - Analyst [14]

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Hi, thanks for taking my questions here. I had a few. So, first question I had was can you talk more about the efficacy rate of Amphora compared to condoms, the sponge, family planning and withdrawal method? And then what is the true effectiveness of the pill?

And then, I know you already elaborated a bit on this in your prepared remarks, but what else does your market research tell you about the appeal of adding on a STI indication? And how would that potentially improve the pricing of your product relative to other oral contraceptives or long-acting contraceptives on the market? Thank you.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [15]

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Great. Thank you, Louise. I'm going to have Kelly start and then Russ jump in.

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Kelly Culwell, Evofem Biosciences, Inc. - Chief Medical Officer [16]

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Sure, yes. So, in terms of the kind of real world or what we call typical use effectiveness of the other methods that you mentioned. So, Amphora really with typical use effectiveness has better efficacy then a lot of the other methods that you mentioned such as the male condom and particularly the female condom and the natural family planning methods when used in the real world.

The kind of real-world or typical use efficacy for the contraceptive pill ranges around 91% to 92% efficacy. So, as a reminder, our perfect use efficacy is actually a little bit higher than that. So, when women can use the product consistently and correctly they can actually achieve really good efficacy.

The other thing that I would note is that for a method like Amphora, consistent and correct use means using the product with each act of intercourse. And so, if you don't use it for a single act of intercourse you're essentially using no method. But that is sort of counted in the, quote/unquote, real world efficacy, as opposed to a contraceptive pill where on average women forget to take their pills three to four times a month, but they have a lot of systemic hormone running through their system.

So, it's kind of a different measurement of the impact of imperfect use. But ultimately, Amphora compares very favorably to all the methods that you discussed.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [17]

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Go ahead, Russ.

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [18]

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And further, when we looked at how the STI prevention indication would come into play, one of the things to note is that there is nothing currently available from a drug perspective that is for the prevention of chlamydia. So, we didn't have an analog specifically to use.

So, what we used was really share preference and asking both healthcare providers and women, after they looked at the target product profile, now if we added to this the prevention of chlamydia how much more interesting is that for you? And what we discovered is about a 25% lift in overall interest in the brand.

So, women and healthcare providers really felt like this was a bit of an opportunity for women themselves to take some of their own -- into their own hands the protection from unknown carriers of the chlamydia and being able to protect themselves in that regard.

So when we looked at this from a payer perspective, one of the things that we are doing now is we're trying to establish a 19th category among payers, which would then allow us to have a better coverage for this from an STI prevention aspect.

So, it's too early to determine what the premium might be in terms of an increase in available reimbursement as a result of that, but we do feel pretty confident that, should we get that indication, there will be significant lift in the product overall.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [19]

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And also too, just to add a couple of quick things to that, is because there's no benchmark, there is no product approved for the prevention of chlamydia, when we did our market sizing what this allows us to do is just to grow a bigger percentage share of the contraceptive market. So, we think that's going to be very, very advantageous.

The other thing that it allows is a little bit of growth and diversity in patient demographics. So for example, not to over share, but there's a whole subset of women that can no longer get pregnant that are 50-plus, like myself, but who could still get chlamydia, for example.

And so, when we've done research and talked to that subset of women, not only do they like the lubricating properties because they have vaginal dryness and pain with intercourse, but the idea that they have something that offers that with positive sexual satisfaction as well as the prevention of chlamydia is seen as a very big positive. So, I think we'll just be able to grow our base of Amphora users once we add on that indication.

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Louise Chen, Cantor Fitzgerald - Analyst [20]

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Can I squeeze in a follow-up question here?

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [21]

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Sure.

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Louise Chen, Cantor Fitzgerald - Analyst [22]

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Okay. So, some of your competitors have talked about changes at the FDA and making it harder to get a new category designation or that's on hold for a while. I know you're further out in an approval and launch, but how do you think about that and the changes at the FDA?

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [23]

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So, from a category perspective what I would say is this -- is that the biggest difference from us versus some of our other competitors is we're not just simply taking a modality that is already available and refining it in some way by extending the length of time that that modality can be used or using a different type of progestin inside of that modality. Ours is actually a brand-new category as a vaginal pH regulator.

We've had a lot of discussions with those who are associated with adding to these definitions, the categories, and they feel quite confident that there is no other product like ours that has this mechanism of action, unlike some of the other products that may be seeking out additional categories that have a similar mechanism of action with just some adjustments to the way that it's delivered.

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Kelly Culwell, Evofem Biosciences, Inc. - Chief Medical Officer [24]

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Yes, and I would just say, from a just tactical perspective on the reorganization, we actually view the reorganization overall as very favorable. The name of the division that will be reviewing our application will change to the Division of Urologic and Obstetrics and Gynecology. So, what they're doing is creating more divisions which should allow for more efficient reviews and we actually we welcome that. There's been a lot of really positive feedback on that process.

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Operator [25]

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Leland Gershell, Oppenheimer.

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Leland Gershell, Oppenheimer - Analyst [26]

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Yes, good morning, thanks for taking my questions. Russ, you've obviously been in this business for some time and you've had a history of launching products in the category. With Amphora being new -- and thank you for the updated market research as well. And with that perhaps informing your perspective, what gives you confidence and what are the likely kind of positives and maybe also pitfalls that you see as you go to market with this new type of contraceptive? Thanks.

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [27]

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Thanks, Leland. Yes, I'm really excited, Leland, about the market research that we did, because what it was able to do is take an assumption that we had before around the size of the market based on those who had indicated that they were beyond hormones and refine this in a way that allows us to be very pinpointed around how we go to market.

It will help two things. It will help the healthcare provider identify in their own practice to these women are and what they look like. It will help us as we move to DTC to be able to more specifically target them. So, that's a very exciting thing.

So, the one thing that I kind of will address that question of yours is what makes me feel confident is that we truly are a new color in the rainbow. We're not just doing an adjustment to a current formulation and trying to bring out lower doses or trying to change the way that a modality is in terms of delivery. But we truly are a new color in the rainbow.

What that will mean for us, and we've already seen this happen, as we go out and start talking about non-hormonal options -- and an interesting thing is if I said to you or any of your friends, just bring up non-hormonal contraception at a dinner party tonight and you'll see that the conversation around that has tremendous buzz. Because it is in fact a completely unmet need, we expect that the opportunity inside of that to get a lot of share of voice around the whole contraceptive category will be very high.

Further, we also feel very confident from a payer perspective that under the ACA, it's going to fit nicely as one of the options that need to be provided at no co-pay and no deductible. So in other words, women will be able to get this at no out-of-pocket. So, those are the things that make me relatively confident that we're in a very good place to launch into this category quite successfully.

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Operator [28]

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Ram Selvaraju, H.C. Wainwright.

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Ram Selvaraju, H.C. Wainwright - Analyst [29]

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So, I just wanted to ask if you could provide some additional granularity around the secondary endpoints in the Amprevence study and which ones you think are likely to be the most impactful for the potential commercial future of Amphora in this indication.

And also, I wanted to ask if you think that there might be a possibility to identify a way to potentially get Amphora included in some kind of guidelines or formal recommendation associated with the prevention of STIs given the high degree of prevalence of these kinds of infections? Thank you.

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Kelly Culwell, Evofem Biosciences, Inc. - Chief Medical Officer [30]

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Yes, thank you. The main secondary endpoint from the Amprevence trial is the prevention of gonorrhea. And the reason it's the secondary endpoint is because gonorrhea is less common than chlamydia, but it is tested with the same swab. And also, it's highly -- it comes commonly with chlamydia. So, a lot of women are infected -- co-infected with both chlamydia and gonorrhea. So, that is a secondary endpoint.

It's possible that we, even though we did not power the study to detect a difference in gonorrhea, we may see a signal towards the prevention of gonorrhea infection. And so, that would inform how we power our confirmatory Phase 3 trial.

I think that with regards to recommendations for use of Amphora for prevention of chlamydia, I know one of the key areas that could be very important for us is the WPSI, which is the Women's Preventative Services Institute, which puts together the package of preventative services that are recommended to be covered by insurance companies for the prevention -- for primary care for women.

And STI counseling is already part of that package. And so, to have a product that could actually prevent chlamydia, I think that would be a really natural place for us to advocate for that to be part of those recommendations.

And we do in fact already have four medical science liaisons on the ground who are working both with obviously our external experts, but also liaising with some of these key professional groups such as the American College of OB/GYN who are leading that charge. So, definitely that's something that we see in the future.

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Ram Selvaraju, H.C. Wainwright - Analyst [31]

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Great. And then just a couple of other quick items. How do you expect the overall commercial effort behind Amphora to evolve as and when you potentially get the label extension for prevention of STIs?

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [32]

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From a commercial perspective we do anticipate that what our research would tell us, Ram, is that women have said to us pretty clearly that they see this as a, why wouldn't I do this? In other words, sort of this nice insurance policy that says, you never know exactly who's a carrier of chlamydia and, in that regard, I could do something to protect myself. And it makes a lot of sense, especially when I consider the lubricating properties and the benefit for contraception.

So, we do anticipate that at that point we will be in a position to understand exactly what our consumer advertising will look like and what our going to the healthcare providers will look like. We've got a little bit of time before we will be able to definitively say how we will shape that market at that point. But our indication is that the interest would be quite high. And of course, from a public health perspective, we anticipate that that would garner a lot of media and news so we'll be prepared for that.

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Ram Selvaraju, H.C. Wainwright - Analyst [33]

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Are the reimbursement mechanics for Amphora likely to change once you have this additional indication? Or is that not really going to be a factor?

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Russ Barrans, Evofem Biosciences, Inc. - Chief Commercial Officer [34]

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In all of our discussions with them we don't think that the mechanics change at all because of the fact that it is an sNDA. So, if you look at some other products -- and I'll use Mirena as an example that has an sNDA for heavy menstrual bleeding, or you can look at Tricycline that has an sNDA for the prevention of acne. Those other products -- and that's what we use as an analog to say that the reimbursement mechanism for that did not change as a result.

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Ram Selvaraju, H.C. Wainwright - Analyst [35]

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Okay, and then just one final one. One of your strategic investors, PDL, has been informed by one of their investors that this investor wants them to stop making strategic investments. Have you had any discussions with PDL about this situation? Has there been any resolution to this? Do you expect that this could potentially affect PDL's future commitment to potentially providing you with additional capital in the future or is this really not relevant?

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [36]

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Well, so here's what I can say. And obviously I can't over speak for PDL, but look, they have experienced a very nice paper profit from their investment in Evofem already. And given our significant near-term catalysts, we believe it's likely to increase over the coming year. But they do continue to be a very strong partner. And they are a strong partner particularly now as we head into this transformational time for the Evofem story towards commercialization.

And as for the potential for them to continue to support us, I can tell you that we have a lot of various interests. We have interest from potential royalty partners, debt partners, equity investors, but we did speak to PDL and they have continued to reiterate, even on their own earnings call yesterday, that the investment in Evofem was a strategic investment and that they continue to be very pleased with the progress that we've made.

They definitely want to stand behind women's health. They continue to reiterate their belief in this team to execute in this category. And they continue to reiterate that they not only want to maintain support but they'd like to grow their support.

So, although I don't want to take lightly the tough situation that they are in, but I do want to say that we have spoken to them and they continue to reiterate, both openly on their own calls and to us, that they want to maintain and grow their support over time.

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Ram Selvaraju, H.C. Wainwright - Analyst [37]

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And just to clarify, you have had no direct contact with the troublesome PDL investor in question, Engine Capital, right?

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [38]

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That's correct, no contact. None.

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Ram Selvaraju, H.C. Wainwright - Analyst [39]

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Okay, thank you very much.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [40]

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Yes, thank you.

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Operator [41]

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And there are no further questions at this time. I will now turn the call over to Saundra Pelletier for closing remarks.

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Saundra Pelletier, Evofem Biosciences, Inc. - CEO [42]

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Great, thank you. So, I want to close just by reiterating the indisputable truths that in the US today there are millions of sexually active women no longer using hormonal contraception. They are beyond hormones. They believe that they deserve something better. They believe that an innovation should be introduced in this marketplace and we are thrilled to be the organization it's going to offer that solution.

It is both our mandate and our mission to provide women with innovative new options that put them in control of their sexual and reproductive health. We are on the cusp of revolutionizing contraception and transforming the history of our company.

And we are really grateful for the ongoing interest and the support that we receive from people who believe that women's health is a critical and important category. So, we just want to thank you for joining us today and we look forward to speaking with you again very soon. Have a great rest of your day.

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Operator [43]

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Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a wonderful day.