Evofem Biosciences Inc (EVFM) 2018 Q3 法說會逐字稿

Good morning. I'll now turn the call over to Amy Raskopf.

Thank you [Shanelle]. Good morning everyone. Thanks for joining the Evofem Biosciences Third Quarter 2018 Financial Results Call. This is Amy Raskopf, Investor Relations for Evofem.

If you have not already received it, please access the financial results press release issued earlier this morning on our website, Evofem.com under Investors. The webcast of today's call is available there as well.

During the course of this call management will make projections and other forward-looking remarks regarding future events and Evofem future performance which constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995.

The words believe, anticipate, plans, potential, position, expect, will, and other words denoting future events identifies statements as forward-looking statements. These forward-looking statements reflect our perspective on current trends and information and they are not based on historical information.

Such forward-looking statements do not guarantee the future performance and involves risks and uncertainties, including those noted in today's press release as well as Evofem's filings with the SEC, on Forms 8-K and 10-Q. Actual results may differ materially from those projected in the forward-looking statements.

Evofem specifically disclaims any intent or obligations to update these forward-looking statements except as required by law. In addition, we will refer to certain information from government publications and general publications and research surveys and studies conducted by third parties.

This information has been obtained from sources believed to be reliable although they do not guarantee the accuracy or completeness of such information. We have not independently verified market or industry data from any third-party sources.

Information for the replay and the archived webcast of this call is noted in today's press release. For the benefit of those who may be listening to the replay or archived webcast this call was held and recorded on November 7th, 2018.

Please reference our most recent press releases and SEC filings for any subsequent announcements related to the topics discussed.

With that I will turn the call over to Saundra Pelletier, Chief Executive Officer of Evofem.

Thank you, Amy. And good morning to everyone and thank you so much for participating on our call.

As you are aware our focus is on developing Amphora which is our lead Multipurpose Vaginal pH Regulator or MVP-R for the prevention of pregnancy and the prevention of chlamydia and gonorrhea. These are critical areas in women's health where current options are either insufficient or entirely lacking.

So this week is a very exciting week for us because the last patient in AMPOWER, our Phase 3 clinical trial for Amphora for prevention of pregnancy is scheduled for her last office visit, this very week so we'll begin data analysis as soon as this occurs and we continue to expect top-line data by the end of this year which is clearly a very important milestone for Evofem.

If approved by the FDA, Amphora will be the first new and innovative birth control method in almost 20 years. It's unlike anything that has come before it which makes any comparison to existing therapies very difficult.

I think one of our analysts poignantly nailed it in a recent report when he said, we believe the relative efficacy compared with that of other treatments, may not even be relevant.

Following an assuming FDA approval our sales and marketing strategy will focus on creating awareness that women don't have to just deal with an old method or try and tolerate a hormone if they don't want to.

That strategy starts with healthcare providers first. By using attitudinal segmentation, we will identify the early adopters who will quickly honor patient requests as we drive women into the offices.

We have already shown that we can influence women. This has been evidenced by our over-enrollment and the additional interested women who wanted to participate in the AMPOWER trial.

To put this in perspective for you, I want you to imagine, if a man every single day was forced to use hormones to keep his facial hair from growing each day and for decades nobody challenged this but blindly, they took the hormones every day, day after day, year after year.

I can assure you that the first company that provided men with the solution without using hormones would be hailed as a huge success by men all over the world. Now maybe perhaps you might think this illustration is a little over the top because that's not reality for men but it has been a reality for women for decades.

We believe that women whose priorities are avoiding hormones, healthy living, or who find the side effects of hormonal methods unbearable are going to be very attracted to a more natural birth control option that we're going to offer in our MVP-R Amphora.

Per the National Center for Health Statistics two-thirds of women cited side effects as the reason they discontinued hormones. We believe there are two key drivers here.

One is the undesirable side effects of hormones that include weight gain, headaches, acne, bloating, breast tenderness, and loss of sex drive. And two, concerns about the lasting impact of prolonged hormone exposure on their health, and on their future fertility. We expect Amphora if approved will be a very appealing option for these women.

Assuming AMPOWER achieves its primary end point we expect that we will resubmit Amphora in the second quarter of 2019. We will have a six-month review so we expect FDA action in the fourth quarter of next year.

Then we will position ourselves to launch Amphora in January of 2020, again as the first and the only non-hormonal, on-demand prescription birth control method in the United States.

We believe Amphora is going to be an appropriate birth control solution for many of the 16.5 million women in the U.S. who are not currently using any form of birth control but they don't want to get pregnant. These women have an 85% risk of becoming pregnant within one year if they continue having sex without using birth control.

We also completed a user-experience satisfaction survey. This is with women who completed AMPOWER along with their male partners as well as study investigators. We learned that 70% of those women were not using birth control before they entered the AMPOWER trial.

So we believe this, coupled with the strong demand to join the study, underscores both the unmet need and our team's ability to target and successfully reach women who need and desire non-hormonal on-demand birth control.

Next Thursday we are hosting an event, New Options in Non-Hormonal Contraception. The key opinion leaders are Patty Cason who is a renowned women's reproductive health thought leader from UCLA; and Dr. Bassem Maximos.

He's a practicing OB/GYN and an AMPOWER investigator and you can expect to gain really important insights into the current landscape of birth control methods and the unmet needs, as well as Dr. Maximos' own perspective for himself and his patients as they experienced Amphora in the AMPOWER study so I hope you will join in person or you'll join by webcast.

In addition to non-hormonal birth control it's important to highlight that Amphora's vaginal pH regulating properties may also be able to prevent the transmission of certain STDs including chlamydia and gonorrhea. The CDC recently reported that rates of gonorrhea and chlamydia have climbed for the fourth consecutive year in the U.S. with nearly 2.3 million cases in 2017.

The current consensus in the medical community is that preventative measures are greatly needed but there is no approved drug to prevent transmission of these vexing and rising STDs.

As you may remember the FDA has granted Fast-Track designation to Amphora for the prevention of chlamydia and it is designated as a qualified infectious-disease product by the FDA for the prevention of gonorrhea. So we believe this continues to underscore the significant need for preventative therapy like Amphora.

We continue to actively enroll patients in this study which we call AMPREVENCE. It's our Phase 2b clinical trial that will evaluate Amphora for the prevention of chlamydia and gonorrhea in women and if approved for these indications, we expect chlamydia, followed by gonorrhea, will be important follow-on indications after Amphora is already on the market.

We are now sharing scientific information with the medical community through poster and oral presentations at scientific and medical society meetings.

In the fourth quarter alone, we made presentations at the American Society of Reproductive Medicine, the Initiative for Multipurpose Prevention Technologies, and the International Federation of Gynecology and Obstetrics. Similarly, we continue to raise Evofem's visibility with the investment community through presentations and participation in [equity] conferences.

We will continue to seek opportunities to build and strengthen our relationships with investors and with analysts going forward. And in addition to the KOL event that we're hosting next Thursday we'll also be presenting in New York later this month at the Piper Jaffray Healthcare Conference and we'll host one-on-one meetings in San Francisco in January during the JPMorgan Healthcare Conference. We look forward to connecting with many of you at or around these events.

So with that I would like to turn it over to our CFO, Jay File.

Thank you, Saundra. And good morning to everyone. Since Evofem is a development-stage company with no revenue to report, I'm going to move right into a discussion of our operating expenses. For the three months ended September 30th, 2018, research and development costs were $9.9 million versus $6.3 million in the prior-year quarter.

The $3.6 million increase was driven mainly by clinical trial costs; a $300,000 increase in non-cash stock-based compensation associated with stock-based awards granted during the second quarter of 2018 also contributed to this increase.

General and administrative costs were $8.6 million for the third quarter of 2018 versus $2.8 million in the prior-year quarter.

The $5.8 million increase was mainly due to a $5 million increase in personnel costs which included a $4.2 million increase in non-cash stock-based compensation associated with stock-based awards granted during the current period, as well as salaries and related expenses reflecting headcount growth since Q3 2017.

Total other expense was not significant for the third quarter of 2018 which compares to a $65 million of total other expense in the prior-year quarter which included non-cash losses on the issuance of Series D redeemable, convertible preferred stock and for the change in fair value of Series D liquidation preference in 2017.

As a result, net loss attributable to common stockholders was $18.4 million or a loss of $0.71 per share for the three months ended 9/30/2018 compared to a net loss of $75.1 million or a loss of $38.31 per share for the prior-year quarter.

We closed the quarter with $12.1 million in unrestricted cash versus $22.8 million at June 30th, 2018. We expect our quarterly cash burn will decrease to the range of $7 million to $9 million for the fourth quarter of 2018.

Greater detail on our Q3 and nine-month results is available in our quarterly report which we filed on Form 10-Q earlier today.

And with that I'll turn it back to Saundra.

Great. Thanks Jay. So this has been an incredibly exciting year for Evofem. We are thrilled about the progress we continue to make and we have several near-term catalysts that I just want to reiterate.

We will have top-line Phase 3 data for AMPOWER which we expect at the end of this year. With that positive outcome of this trial we expect to refile the NDA for Amphora in the second quarter of 2019 which positions us for FDA action in late 2019; and, assuming approval, we will commercialize in January of 2020.

Evofem is now at the forefront of a revolution in women's health. And that might sound like a big statement but we are convinced that that will be a reality because we expect to be the very first non-hormonal on-demand prescription birth control method for women.

We look forward to providing additional updates on our pipeline progress and our pre-commercial activities going forward. So with that Operator, please will you open the call to questions.

Thank you.

(Operator Instructions)

Our first question comes from the line of Randall Stanicky of RBC Capital Markets. Your line is now open.

Hey, thanks guys. Saundra, you guys are about to switch from a clinical company to a commercial focus here, very near-term. How are you guys thinking about that roll out?

I know the launch is early 2020 but that probably implies a lot of heavy lifting in preparations over the 2019 year. So maybe just start with how we should be thinking about the ramp in preparations for the launch over the next year, and maybe how any of the satisfaction-survey work that you've done have helped inform that strategy? Then I have a follow-up.

Perfect. Okay, Russ, [will you]?

Sure. Thank you, Randall. This is Russ Barrans, the Chief Commercial Officer.

And we have begun the process now as we are just roughly almost 12 months out of establishing our commercial infrastructure so we're currently in the process of adding in our Marketing Department. We will put in our Medical Scientific Liaison team and our Market Access team early in the year, next year, and then move towards hiring of our Sales organization with first and foremost the managers in the third quarter, with the reps in the fourth quarter of next year, going through some at-home study in the month of December, then with our launch that will happen in January of 2020.

The survey that we did conduct with those women who have completed and their partners has certainly helped to validate a lot of the things that we had looked at in market research, understanding that the women who were most likely in need of and interested in finding out more about an Amphora-type product would be those who were previously doing nothing, a part of the 16.5 million women that Saundra referred to earlier.

And so when we discovered that in fact 70% of them were not doing anything before they entered into the trial, it validated all the things that we had assumed before and has set us off into a really nice direction.

Saundra had mentioned earlier the attitudinal segmentation that we're doing among healthcare providers. And that, actually, Randall, is being finalized even this week, tomorrow as we have a large session here in our -- in-house to get some of that done.

The other thing just to add, Randall, is that when you really look at the footprint of prescribing OB/GYNs who make up the majority of the contraceptive landscape, we -- our intention is to have 85 sales reps with 10 managers and then to have a small Telesales team to cover the geographies in which we don't need a full-time sales rep to target. But that is very adequate to cover deciles 6 through 10, if you will, of the prescribing base that we want to focus which is about 12,000 providers.

Russ, I mean let me delve down a little bit more. I mean you've been through some pretty big launches in the women's health area before. I mean as you think about the MVP-R positioning, this is definitely a -- it's a unique product, right?

And we haven't seen a product like this come into the -- I want to call it the women's health space rather than the contraceptive space, per se -- in a long time, if ever. And so how does that change your thinking from the traditional types of roll-outs particularly as you think about DTC and trying to go after some of these women who may not be traditionally walking through the door of their OB/GYN?

Yes, Randall, as you mentioned when we brought Mirena to the market back in early 2000, one of the key things that we discovered shortly after we came to market roughly in the 18-months range was that it was necessary to build out a different segment; because just like Mirena had ended up building out a segment that didn't exist previously, we understand that we have a very similar segment which these women have more or less, if you will, given up because there isn't anything there that has really been provided for them.

So when we started looking at that -- at that time and we changed our messaging in a way that ultimately brought OB/GYNs into being big advocates for Mirena, we think and we believe we can do the same thing in this situation.

So with our DTC we did get a chance to try out, if you will, the messaging that we will go out to market with by targeting specifically for our clinical trial those areas where we would see women congregating that might be more interested, for example: Mommy Blogs, women who are currently breast-feeding; we also went to holistic living sites and places like that where we felt like those women would more likely exist and we were able to find them quite easily.

So we're very confident that today with digital marketing on social media and all those kinds of places that we can find those women and let them know about the opportunities that are available now that were previously not available.

Okay. That's great. And my last question, can you just remind us of the timeline on the Phase 2b, the chlamydia trial in terms of when we can expect data, how you're thinking about the Phase 3 program; and assuming you've got some blessing or you will have some blessing from FDA on that; and then ultimately when we could expect that to get into the label if all goes well? Thanks.

Yes. So as I think we stated that that would be a follow-on indication and so where we are now is that -- so next year in 2019 we are anticipating to have top-line data by early fourth quarter of 2019 for the chlamydia study.

And so we are -- we are very much on track. So for example, we have 550 patients enrolled to date out of the 850 that we intend to enroll so everything is proceeding quite nicely. So by the fourth quarter of next year we will be hopeful to be able to deliver positive top-line data on that study.

And that's when -- Phase 3, post-data?

Yes.

Okay. Great. Thanks, guys.

Thank you.

Thank you. Our next question comes from the line of Bill Tanner of Cantor. Your line is now open.

Thanks for taking the questions. I have a few, Saundra, if I could.

I notice as it relates to the primary endpoint is the Kaplan-Meier analysis, the number of women did not become pregnant. So just if you can give us some sense maybe of the data that -- the top-line data that you contemplate releasing, I'm assuming it's going to be more than that; I know that obviously safety is a component as well but just a sense so that when we look at the data we are prepared to know what we're looking -- what we should be looking at if there are any ancillary cuts of the data that might be contemplated to be at least released over the nearer term?

Okay, I'm going to have Kelly start.

Right. So yes. We will have the initial efficacy data, the 7-cycle cumulative failure rate as well as initial safety data around adverse events and serious adverse events as well; and that's the basic top-line data that we'll have.

We're also going to include two different efficacy rates, both the typical-use and perfect-use efficacy rates, and a little bit of information about dosing deviation.

So we have been collecting very detailed information from women about when they use the product in relation to when they had sex through the e-diaries and so we will have some information about the efficacy rates for women who use the product at different intervals as well.

Okay. And then I know the -- some of the data that the company has presented previously relate to the typical use and the perfect use. I mean, those terms, are they -- I mean is that something that's going to be more sort of qualitative as it relates to the data? Is that something that the FDA acknowledges as I guess a valid benchmark, if it were; or a delineation of how --

Yes.

-- well women actually use it, use the product?

Yes. So we have very specific definitions for what those mean. So typical use is really defined as exactly what the FDA has required us to put in our primary analysis. So that includes not only women who use the product as a user but also we -- any time a woman doesn't report any sex for a month, we throw that cycle out, so it's a very specific definition.

Perfect use is really both around the way that the woman uses the product and the way the woman reported in her diary and that she followed the protocol. So basically, we consider perfect use to be per protocol and the typical use to be the sort of intention to treat.

Got it. Okay. And then is there a contemplation that you'd meet with the FDA prior to the refiling? And if so -- I don't know if there'd be any commentary that might come back to the Street after that?

Right. So that will be determined based on the initial results that we see. So if everything is as we expect it, we may not need an in-person meeting. But we will be making that determination once we have our initial results. And that would occur likely in the first quarter, early second quarter of next year if we needed to have the in-person meeting.

We may request it as a teleconference or written comments but we will definitely be doing a pre-NDA submission and then we can provide the information following that.

Got it. Okay. And then maybe a question for Russ.

I know that we typically think about drugs to treat illnesses, maybe there's some disease awareness, they can happen that a company can engage in without specifically referring to a product. And I'm wondering if you feel like you've got good data and Amphora is approvable; if there's anything that could be done prior to the launch, that would be compliant with the FDA just in terms of raising awareness for a novel -- a new -- a novel, non-hormonal contraceptive methodology to lay a little bit of the groundwork or raise the awareness?

Yes. We do intend on doing as is usual referred to as a disease awareness type of non-branded campaign because there are other non-hormonal products that are in the market, none that are on demand; as long as we stay within that category of building out the non-hormonal category and if you think about the non-hormonal IUD that really is a different patient. So we feel really confident that in just building awareness of the fact that there's non-hormonal contraception is coming to the forefront that can be used as a woman needs it, as opposed to having to have an invasive method like a IUD, we will be able to prep the market appropriately.

And then I did mention the MSLs previously and they will start speaking to the medical community, being able to have those medical dialogues back and forth in a very direct manner and we'll have those on in the first quarter of '19 as a prep for the market in -- beginning of '20.

Got it. And maybe just last question just thinking about this temporally, if you -- if you think you get approval in the fourth quarter, and the January launch sounds kind of aggressive. And not to really try to pin you down, but it seems like you might be contemplating an early in the fourth quarter approval. And just wondering, what kind of ancillary things would need to be done post-the formal approval to get things ready to be able to launch in such -- it seems like kind of a compressed timeframe?

Well. Let me start and then maybe you jump in. I mean we do intend -- assume everything unfolds the way that we intend it to, then we do intend to do a soft launch, if you will. So let's say we have an approval in the fourth quarter in a timely fashion so we will do a soft launch and some of the components of the soft launch -- so the sales force will be absolutely prepped and prepared.

We'll look at who -- some of those early adopters are and so there will be some activities that we'll undertake but the real official launch will be January.

But just to speak to the compressed timeline, I mean I will tell you, we've been ready for this for a long time and so I couldn't even express to you -- you're talking to a team of people, we could launch this tomorrow. If the FDA were to give us approval tonight, we would be ready.

And I say that because we've done a lot of the work already, we've just had to refresh some of the -- looking at some of the segmentation but frankly we have our branding, and our messaging, and our positioning, and we've aligned the team. And so I feel very confident that we'll be able to hit the ground running.

And I don't know if you want to speak to the soft launch or -- good? Okay.

Does that -- yes, does that answer your question, Bill?

No, it does, it does. I guess I'm just thinking, gosh, if you can do it in January and I don't know if it's in your marketing budget. But I know you don't know what Super Bowl commercial time is, but that would seem to be a pretty --

I like how you think.

You kill a (multiple speakers) lot of birds with one stone there.

But one of the things that I want to make sure we highlight is we understand the importance of making sure that the healthcare community is really versed and well informed before we go out heavy with our consumer campaign. So that will come later in the year in 2020 as a -- if you will, the launch of our consumer campaign that is intended to drive women in by large numbers in that fashion because we know that healthcare providers are willing to use the products women request if they are familiar and comfortable with it. But one thing they hate is that someone walks in and says, can I have product X and they've never heard of it before and then they get awfully mad at the company that produced product X.

Yes. Okay. All right. Thanks very much.

Thank you. Our next question comes from the line of Leland Gershell of Oppenheimer. Your line is now open.

Hey, good morning guys. Thanks for taking my questions. Wanted to first ask about the messaging and positioning, how the -- how the new -- the nomenclature of the MVP-R has been resonating amongst different contingents out there whether physicians, potential users, and so forth?

Yes. Thanks, Leland; so actually it's been resonating exceptionally well. Once you say that it is a Multipurpose Vaginal pH Regulator it's as though everyone fully understands exactly what that is, then the question that comes is, tell me what it does?

And that puts us in a really good position because we get a chance to talk about the very first entry being into the birth control category. So it's been received exceptionally well and has helped us bring to a better understanding from healthcare providers.

We haven't gone to consumers yet because I think we're a little bit too far out to get that messaging refined with them. And we may not end up using that same nomenclature with them because it might be considered to be a little bit too high science for some of them. But at the healthcare community what we found is that when we layer on then those other additional indications and products, for them it's made complete sense; and we, if you will, sort of turned the corner in helping people understand what it is we actually have in our possession.

All right. Great. And then we all look forward to next week's events and hearing from the KOLs. Will the company be having any additional disclosures on any of the market-research work or patient -- you know, potential patient feedback on the product?

What we'll -- what we'll end up doing is as Saundra said, in terms of like the satisfaction survey, well that will be shared in some scientific community -- symposia later on in the year and some of those things. But next week we won't have anything additional to be able to share.

All right. Fair enough. Thanks very much.

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

Hi team, congrats on the continued progress. A couple of questions. First can you kind of remind us again how the baseline demographics of women in the AMPOWER study differ from AMP001, if there are any differentiations?

Then can you give us also some color along the lines in regards to the drop-out rates of AMPOWER so specifically maybe just comment on whether it's in line with AMP001 or historical contraception trial?

Unfortunately, we don't have data for either of those points yet as the database has not yet [unlocked] and we've not done any data analysis, either of the demographics or of the follow-up rates or drop-out rates.

But in regards to inclusion or exclusion criteria that between AMPOWER versus AMP001 should have been pretty much consistent between one another, is that correct?

Oh sure, sure. So yes, the inclusion criteria is fairly similar. The primary efficacy population for AMP001 was the 18- to 35-year-olds.

We did have an additional safety population in AMP001 that went up to 45 but they were included in the original efficacy population. And for AMPOWER we are only enrolling the 18- to 35-year-old women. The remainder of the inclusion criteria are very similar between the two studies.

And Yasmeen, we do anticipate that many of the women who may have joined were perhaps more motivated to do non-hormonal therapy this time because we specifically tried to go out and recruit in those areas. So we will be very interested in looking at that data ourselves to see if in fact that turned out to be true.

We did see as Saundra mentioned that there was about 70% of women that we spoke with in post-trial that we spoke to in our survey that indicated that they weren't using something previously so we would anticipate demographically that they might fit into that category that we were talking about; age-wise and those kinds of things we really don't know yet.

Thank you. And then maybe like a last question in [regard]. So assuming Amphora comes out spot clean as we saw already out of those Phase 3 study.

We do know that there are a number of sort of barrier-designed contraceptions that are available on the OTC market. How is -- how do we know or what is our guidance thinking about that this product will not be [an OTC you know,] a drug?

Yes. So this is Kelly, the Chief Medical Officer. And we have had multiple conversations with the FDA and in all of our conversations we have been informed that this product will be a prescription contraceptive and all of the discussions that we've had thus far have been around the approval as a prescription contraception.

And in the early days when this new team came on to have interface with the Agency and talk about this, we had discussions regarding the provider interface and how critical it was for an on-demand method and that everybody recognizes that if you don't want to have systemic side effects the trade-off is you have to use it for it to work and so the provider interface is very important which you wouldn't have if it was an OTC product.

So we feel really confident in all of our ongoing discussions that this will be a prescription product.

Right. And the FDA has indicated that they agree with us that this is a new -- basically a new -- a new type of product, and innovative new type of product which is another reason that they are happy and enthusiastic about having the provider interface.

Thank you. Sorry, maybe one quick question along the lines of what Bill asked. So in anticipation of the Phase 3 results, are you going to provide then the rate of typical use and perfect use and the top-line number like the differentiation, both of those numbers will be reported?

We have -- will have both of those numbers and I -- yes, the Agency is most interested in having both of the numbers. The typical use is the result that's the kind of ITT analysis and so -- (multiple speakers)

Yes, but the Agency -- I guess the reason we're sort of saying is the Agency will have to look at this once we -- so we don't know we have top-line data as everybody knows, the Agency will then have to go in and do their own evaluation and there could be some adjustments accordingly based on that.

So we -- although we will collect it, we want to make sure we're mindful of the timeline that has to exist for the Agency to also evaluate it before we know this is what the numbers are really going to be.

Okay. Thank you.

Thank you. Our next question comes from the line of Ram Selvaraju of H.C. Wainwright. Your line is now open.

Hi there, this is Julian on for Ram. Thanks for taking my questions. Beyond Amphora when should we expect to see additional incremental clinical data on MPT gel?

Hi everyone, apologies for a strange and unforeseeable technical glitch but thanks for holding with us while we dial back in. I'm sorry, I believe were in the middle of a question with Julian, is that right?

Can I ask a question or should I start over?

If you could start over that would be great.

All right. So my question was, beyond Amphora, when should we expect to see additional incremental clinical data on MPT gel?

So the -- as Saundra mentioned earlier, the Phase 2b study for prevention of chlamydia, we anticipate that we will have top-line data by Q4 of next year as the recruitment has been going very well for that study and we're over halfway recruited for that trial.

We are also evaluating opportunities for the -- next study for prevention of occurrence of bacterial vaginosis but we don't have guidance yet on when we will have data for that indication.

Okay. Got it. Thanks for that. And for my second question, I was just curious if you have any thoughts on Pfizer's pending decision to exit the women's health arena and what that might mean for the space going forward?

Well I guess I would say we -- look, we continue to think that there are lots of compelling opportunities to enter into women's health and to grow women's health and to focus on women as the healthcare consumer, as they are the decision-makers in many of their households not just for themselves.

So we really believe focusing on unmet needs in these categories that impact women is very, very critical for shareholder return, as well as addressing unmet needs. So I guess I would say we think that -- opportunistically we think there's opportunities to attract some talent frankly that we know as we are building our organization, our commercial footprint, there are people that we want to identify in those kinds of organizations.

And so I don't know if the team has anything else they want to address. But I do -- look, I think it's -- I think the testing for women's health in general is that a lot of these assets sometimes are quote, if you will, just sort of milked. And I do think that we've seen lots of instances where Russ for example and his team have been involved, where if you make small adjustments and modifications either with an additional indication or different messaging and a different segmentation of the market you can still grow big revenues. So for an organization like Evofem Biosciences, billion-dollar products are really important.

So I guess you can understand from a big macro-level why some of these organizations choose to focus on different therapeutic areas but for us our passion continues to be women's health.

Okay. Great. Thanks very much.

Thank you. Our next question comes from the line of Carl Byrnes of Northland Securities. Your line is now open.

Right. Congratulations on the progress. What data from the prior trial do you anticipate including in the NDA resubmission?

Yes. So we, in conversations with the FDA, we have been informed that we can include all of the previous safety information for -- as supplemental safety data for the NDA resubmission. So we'll be doing and integrated safety analysis that includes both of the trials.

And just for your reminder, AMP001 enrolled more than 3,400 women so we have an extensive safety base from -- a safety (inaudible) space on the first trial as well.

Great. Thanks much.

Thank you. And I'm showing no further questions at this time. I will now like to turn the call over to Ms. Saundra Pelletier for closing remarks.

Great. Thank you very much. So thank you to all of you for joining us this morning, your time and your ongoing support of Evofem is very, very appreciated and so important to us.

And we look forward to seeing many of you at our KOL event next Thursday, if not there perhaps additionally at the Piper Jaffray Healthcare Conference in New York later this month. And we really look forward to continuing to update you. So thank you again and have a great rest of your day.

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