Evofem Biosciences, Inc.
Q3 2019 Earnings Call Transcript

Published: 10 Nov 2019

[Operator:]

Good morning, and thank you for joining the Evofem Q3 Financial Results Call. I'll now turn the call over to Amy Raskopf.

[Amy Raskopf:]

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 aftermarket 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.

[Saundra Pelletier:]

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. They're 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 women.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.And four, is our lead Multipurpose Vaginal pH regulator or MVP-R candidate. This innovative hormone free, surfactant free, vaginal gel regulates the 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 asset. Already, we are advancing pre-commercial activities to ensure that we're prepared for the potential FDA approval and 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?

[Jay File:]

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

[Saundra Pelletier:]

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 resubmissions 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, o9ne 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 ID, condoms, withdraw, 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 health care providers will welcome and embrace Amphora for its unique proposition as hormone free as female control birth control that's used in the moment.Let's also not forget that in the AMPOWER trial, and 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 was on the potential for the prevention of chlamydia, which is the most common reportable infectious disease in the U.S. 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 U.S. and with no products approved for the prevention of chlamydia, the unmet need is very clear.Our placebo-controlled AMPREVENCE trial was conducted at 15 U.S. study centers and enrolled 860 women who've 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 products in the U.S.While we have not yet provided guidance on the potential launch trajectory for Amphora, what I can say is that the current market data continues 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 U.S. mindset and the U.S. market. Russ?

[Russ Barrans:]

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 armor material [ph] 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 investigating 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.The research company extrapolated the findings to be approximately 45 million women who are candidates for contraception. The research identifies 17 million women who, because of their dissatisfaction with current birth control or their interest in seeking out non-hormonal options, fit with Amphora's 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.

[Operator:]

Thank you. [Operator instructions] And our first question comes from Randall Stanicky from RBC Capital Markets. Your line is open.

[Unidentified Analyst:]

Hi, good morning. This is Ashley on for Randall. So a contraceptive patch had its AdCom recently with kind of a positive vote around the risk benefit profile support and 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?

[Saundra Pelletier:]

Yes. Kelly Caldwell, our Chief Medical Officer, I'm going to ask her to start.

[Kelly Culwell:]

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 - 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, to being able to launch Amphora to add to those contraceptive options as a hormone-free option in 2020.

[Unidentified Analyst:]

Correct. Thanks. And just one follow-up, what's your expectation around the timing of end of Phase 2 meeting with FDA for the STI's? And I think you mentioned earlier in the scripts that this could be kind of one of two pivotal trials. Could you just kind of talk, talk us through like what you're expecting around the design of the trial, enrollment and such? Thank you.

[Saundra Pelletier:]

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 through the agency at that time our plans for our confirmatory Phase 3 trial and as you noted, should AMPREVENCE trial hit its primary endpoint, then we have been in discussions with the agency that would be one or two pivotal trials. So we 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.

[Unidentified Analyst:]

Got it. Thank you so much.

[Operator:]

Thank you. Our next question comes from Yasmeen Rahimi from ROTH Capital Partners. Your line is open.

[Rachel Yang:]

Hi, this is Rachel Yang on for Yasmeen. Thank you for taking my question. 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, how close versus the real world? And how does the safety and dropout compare when put those two data sets together? Thank you.

[Saundra Pelletier:]

Sure, thanks for the question. So to start, our efficacy for the approval of the product is based solely on our second Phase 3 trials. So the efficacy results that we have previously reported are the efficacy results that are going in for our - for the approval. The safety profile is going to be - is going to include both of the Phase 3 trials and the safety profiles are incredibly similar across both trials. And as noted before, we have more than 19,000 cycles of exposure between the two studies.So very extensive database, safety database, again, less than 2% of women discontinuing the trial due to any adverse events, around 1%, serious adverse events rate raised, none of which were deemed to definitively related to the product's use and that was consistent across both trials. The patient demographics also are very consistent and also very consistent with the U.S. 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 U.S. population between then and now.

[Rachel Yang:]

Very helpful Thank you so much.

[Saundra Pelletier:]

Sure.

[Operator:]

Thank you. Our next question comes from Ram Selvaraju from H.C. Wainwright. Your line is open. Please check that your line is not on mute. And we'll move on to our next question. Our next question comes from Louise Chen from Cantor Fitzgerald. Your line is open.

[Louise Chen:]

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 is 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.

[Saundra Pelletier:]

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

[Kelly Culwell:]

Sure. Yes. So in terms of the - perhaps 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 than 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 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 active intercourse. And so if you're - 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 "clinical real world efficacy" as opposed to a contraceptive pill where on average, women forget to take their pills, three to four times a month, and - but they have a lot of systemic hormone running through their system. So it's kind of a different measurements of the impact of imperfect use. But ultimately, Amphora compares very favorably to all of the methods that you discussed.

[Saundra Pelletier:]

Go ahead, Russ

[Russ Barrans:]

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 of 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.

[Saundra Pelletier:]

And also 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, all - 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 demographic. So for example, not to overstate here, 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 little 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.

[Louise Chen:]

Can I squeeze in a follow up question here?

[Saundra Pelletier:]

Sure.

[Louise Chen:]

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?

[Jay File:]

So from a category perspective, what I would say is this is that that was 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 progesterone 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 have 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.

[Saundra Pelletier:]

Yes, and I would just say, from a 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 your logic and obstetrics in 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.

[Louise Chen:]

Thank you very much.

[Operator:]

Thank you. And our next question comes from Leland Gershell with Oppenheimer. Your line is open

[Leland Gershell:]

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.

[Russ Barrans:]

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 pinpoint around how we go-to-market. It will help two things. It'll help the healthcare provider identify in their own practice who 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 the 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 that's happen, as we go out and start talking about non-hormonal options and the interesting thing is if I said to you or any of your friends just bring up the non-hormonal contraception at a dinner parties 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.

[Operator:]

Thank you. And our next question comes from Ram Selvaraju from H.C. Wainwright. Your line is open.

[Ram Selvaraju:]

Thanks very much. Can you hear me now?

[Saundra Pelletier:]

Yes, we can now. Perfectly.

[Ram Selvaraju:]

Okay, perfect. 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 around for 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 types of infections? Thank you.

[Saundra Pelletier:]

Yes, thank you. So the main secondary endpoint from the AMPREVENCE trial is the prevention of gonorrhea. And the reason is 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 the difference in gonorrhea, we may see a signal towards the prevention of gonorrhea infection. And so that would inform sort of how we power our confirmatory Phase 3 trial.I think that with regards to recommendations for use of Amphora 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 is puts together a 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.

[Ram Selvaraju:]

Great. And then just a couple of other quick items. How do you expect the overall commercial efforts behind Amphora to evolve, as an when it potentially gets the label extension for prevention or STIs?

[Russ Barrans:]

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 is 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 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 their 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.

[Ram Selvaraju:]

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?

[Jay File:]

In all of our discussions with them, we wouldn't - we don't think that that mechanics changes at all because of the fact that is an SNDA. So if you look at some other products then I'll use Maraina [ph] as an example that has an SNDA for heavy menstrual bleeding or you can look at Tricyclin [ph], that has an SNDA for the prevention of acne. Those are the products and that's what we use sort of as an analog to say that the reimbursement mechanism for that did not change as a result.

[Ram Selvaraju:]

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? Future commitment to potentially providing you with additional capital in the future or is this really not relevant?

[Jay File:]

Well, so here's what I can say. And obviously, I can't speak for PDL. But look, they have experienced a very nice paper profit from their investment, and that's with them 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're 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 overtime. And just to clarify, you have had no direct contact with the troublesome PDL investor and questioned Engine Capital [ph], right?

[Saundra Pelletier:]

That's correct. No contact.

[Ram Selvaraju:]

Okay, thank you very much.

[Saundra Pelletier:]

Good. Thank you.

[Operator:]

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

[Saundra Pelletier:]

Great, thank you. So I want to close just by reiterating the indisputable truth, that in the U.S. 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 that's going to offer that solution. It is both our mandate and our mission to provide women with innovative new options that puts them in control of their sexual and reproductive health. We're on the cusp of revolutionizing contraception and transforming the history of our company.We're really grateful for the ongoing interest and the support that we received 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.

[Operator:]

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.