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spk07: Good day and thank you for standing by. Welcome to the Evopem Biosciences First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Amy Raskoff. Please go ahead.
spk03: Thank you. Good afternoon, everyone. If you haven't done so already, I encourage you to access the press release we issued earlier today and the webcast presentation that accompanies this call, both of which are at evofem.com under the Investors tab. Before we begin, I would like to remind you that remarks on this call will contain forward-looking statements, which are made only as of today, May 6, 2021. For a more detailed description of important risk factors that could cause our actual results to differ materially, please refer to our annual report on Form 10-K and our most recently filed 10-Q. With that, I'll turn the call over to Sondra Pelletier, EvoFem's CEO.
spk08: Thank you, Amy, and thank you to everyone for joining us today. The first quarter of 2021, EvoFem delivered strong growth, driven by our Get Sexy DTC campaign, which we launched nationwide on Valentine's Day. Due to the immediate success of this multi-channel marketing campaign and our sales force's persistence during these challenging times to access healthcare providers, we reached new highs across all metrics, including Phexie total brand awareness, total prescriptions, prescriber-based growth, and most importantly, revenue. We expect this campaign will continue to drive consumer awareness and utilization of Phexie for the foreseeable future. In addition to launching a successful DTC campaign, we advanced several important initiatives during the quarter, including our drive to gain a new category for FEXI as a vaginal pH modulator on the FDA's contraceptive categories chart, our collaboration with ENCODA to raise awareness of FEXI in the oncology community, growth to net improvement strategies that are already having a positive impact on our operating results, and discussions with potential partners for commercialization of FEXI in multiple geographies outside of the United States. I'll discuss these initiatives and our expectations for FECSI and our phase three STI prevention clinical trial after our CFO, Jay, files, reviews the financial results, and Russ Behrens, our chief commercial officer, discusses DTC impact.
spk04: Jay? Thank you, Sondra, and good afternoon, everybody. Before I start, I want to point out that I'll be rounding all numbers in today's presentation. The first quarter of 2021 was our second full quarter of product sales and included six weeks of sales following the Get Sexy DTC campaign launch. Compared to Q4 2020 levels, gross revenues increased 293%, driven by strong growth in ex-factory unit shift. In factory, ex-factory unit sales surpassed full-year 2020 levels by 51%. Net product sales were 1.1 million, compared to 170,000 in the fourth quarter of 2020. The increase reflects higher gross revenues and more favorable gross-to-net adjustments in the current period. We expect GTN adjustments to significantly improve throughout the remainder of the year, driven by a series of GTN improvement strategies that we began implementing in April as part of our overall strategy to build sexy trial usage and loyalty. For the first quarter of 2021, total operating expenses were $46 million. Cost of goods sold was $500,000. Research and development costs were $7.3 million, which was primarily clinical trial expenses for Edelgard and personnel costs. Selling and marketing costs were $30.5 million, reflecting the commercialization of VEXI, including media, advertising, and public relations expense and Salesforce costs. And general administrative costs were $7.7 million. Excuse me. Cash and cash equivalents was $45.3 million at March 31st, 2021, which includes $28 million in net proceeds from an underwritten public offering completed in March. At Q1 close, we also had $18.6 million in restricted cash from the adjuvant notes available for use. In April, we raised an additional $4.2 million in net proceeds from the exercise in full of the underwriter's over-allignment option in conjunction with the March raise. With that, I'll turn it over to Russ for more detail on commercialization and Thank you, Jay.
spk05: As Sondra mentioned, we launched our direct-to-consumer campaign, GetFexy, on Valentine's Day, and the impact has been significant. Overall, Fexy brand awareness tripled to over 12% in March, and we saw a 63% increase in women's interest in Fexy between January, which was the last full month before the DTC campaign, and March, our first full month after the GetFexy launched. In just a few short months, Phexie's social media followership has surpassed that of other recent entries in the contraceptive category and now actually exceeds all contraceptive brands, including the very successful Mirena family of IUDs. This validates what we told you previously. Women are keenly interested in an innovative non-hormonal in-the-moment contraception that stays in place during the active intercourse. total prescriptions of Phexxi increased 83% from February to March. Phexxi has achieved a major milestone with more than 5,000 healthcare providers who have written a prescription for Phexxi since launch. We saw a 78% increase in Phexxi prescribers from February to March with nearly 1,400 new prescribers and first-time prescribers of Phexxi increased 98% in that same time period. Based on market research that was conducted at the end of March, and let me say, this is really quite significant, 93% of women who discussed Phexxi with their HCP got a prescription for Phexxi. Those are tremendous results, and I could not be more proud of how Phexxi is shaking up the contraceptive market. Now, I've been asked by many of you and others, who are those early users of Phexxi? High-level data from our third-party AI partner indicates these women are coming from four distinct segments. First, women currently or recently using a hormonal birth control pill. Second, those women who are currently or previously used other daily or weekly hormonal methods like the patch or the ring. Third, a segment comprised of the 23 million women who are not using any form of prescription contraception, including those who are not using contraception at all but are still sexually active. And finally, Phexxi is even capturing women who are transitioning from larks like IUDs and implants. Marker research and now, of course, real-world experience shows that this very significant group of women like, for example, Pilpia from our Get Phexxi campaign have been waiting for an option like Phexxi so they are able to say, no more synthetic hormones in my body. Finally, I've mentioned the GetFexy commercial already a few times, and I hope that by now all of you have taken time to go to YouTube and see it for yourself. We would like to thank Fierce Pharma for recognizing GetFexy in the Fierce Madness DTC competition alongside other ads from large pharma, including J&J, FAIR, and Moderna. Our second place finish by the slimmest of margins, actually just eight votes, is a personal point of pride and further demonstrates how appealing GetFexy has been and how much it resonates with our audience. If I can, I want to touch quickly on just some of the future promotional efforts that are going to take place. While I'm not going to share very many details for competitive intelligence reasons, of course, I am confident that we continue to have a game-changing strategy to shake up this category. I know from firsthand experience that contraception is highly sensitive to consumer promotion, and we are going to continue to drive Fexy awareness to record-setting heights. Now, you may have noticed, more likely if you're in our target audience for PECSI, that several weeks after GetPECSI launched, you stopped seeing the ads during your evening cable TV, and you were right. We're using a proven model whereby TV and video media content are pulsed in certain cadences instead of just running in a predictable sequence. Anything that becomes predictable becomes white noise. So we strategically put placements of our ads in so that they would be effectively using our marketing spend to achieve our prescription goals. And also, keep in mind that cable TV ads are just one aspect of our DTC campaign. They are supported by streaming and digital media like Hulu and YouTube, social influencers, and so on. You may also have noticed new social media influencers posting about PECSI. We are currently working with many different Instagram influencers who have more than 3 million followers in aggregate. Last month on PECSI's Instagram, we also debuted Unfiltered, our new monthly newsletter. sexy video series aimed at tackling the most common questions from our female audience, all packaged in a fun and engaging way on social media. Over the next year, our own chief medical officer, Dr. Kelly, will be featured in one video per month providing her expertise as an OBGYN. And there's still more to come, including the announcement of a celebrity endorsement that we are patiently waiting to reveal in our Q3 call. Before I turn it back to Sandra, I want to summarize. Q1 was a great quarter from a commercial perspective, marked by significant accomplishments, including exponential unit sales and prescription growth, the launch of the Get Pepsi campaign, and a growing number of new and returning HCP prescribers. an indication of extremely high levels of acceptance resulting in the rapid expansion of our user segments. And with that, let me turn the call over to Sandra.
spk08: Thank you, Russ. I'm now going to focus my comments on three key areas of our business today, ACA, partnerships, and our pipeline. We currently have PECC coverage for 55% of commercial lives and 100% of the Medicaid population. Our Medicaid agreement took effect on January 1st, and we're seeing growth in this segment as well as among commercially insured patients. As we discussed on the call in March, we have purposely refrained from getting into long-term, deeply discounted rebate contracts with the PBMs because we are confident that we will succeed in gaining a new category for FEXI as a vaginal pH modulator on the FDA's contraceptive categories chart. We feel very strongly that our ACA efforts are going in the right direction. In addition to working with lobbyist Jeff Ruschetti, we have been aggressively pursuing and have received enthusiastic support from U.S. senators, state representatives, and women's advocacy groups across the country. We have contacted and confirmed engagement on this matter with people and offices, including Senator Patty Murray, who serves as the chair of the Senate Health Committee, which is health, education, labor, and pensions, and is chair of the Appropriations Subcommittee on Labor, Health, and Human Services and Education. Senator Susan Collins. who also serves on the Health Committee and on the Senate Appropriations Committee. Senator Tammy Baldwin, also serving on the Health Committee and on the Senate Appropriations Committee. Senator Maggie Hassan, also serving on the Health Committee. Senator Ben Cardin, who serves as the Senate Committee on Finance and the Subcommittee on Healthcare. And our own San Diego representative, Scott Peters, who serves on the House Budget Committee. Among women's health advocates, we have spoken with many influential groups who share our convictions. and have agreed to escalate this critical initiative on behalf of women. This includes the renowned consumer advocate, Erin Brockovich, the National Women's Law Center, Population Services International, Physicians for Reproductive Health, the Reproductive Health Access Project, ENCODA, the United Populations Fund, IBIS Reproductive Health, the Global Women's Institute, the National Women's Health Network, FemTech Focus, and the Malala Fund. Gaining this new category would provide increased access with no out-of-pocket costs for FEXI across the United States. As I hope you see, this is not a desire we are waiting to have dropped in our laps. We are taking serious action in support of women getting access to FEXI. When a woman cannot use a hormone, she should not be denied access to the only on-demand hormone-free prescription drugs approved by the FDA. And I want to remind you, this is not about us. It's not about the 23 million women who are already beyond hormones. This is about all of the women who should not, cannot, and will not take hormones, like the 75% of women who we surveyed over the last six months who would not use hormones if they had an acceptable non-hormonal option. So speaking of these women who cannot take hormones, earlier this year we launched a collaboration with the National Community Oncology Dispensing Association, NCOTA. It was to raise awareness of VEXI among ENCODA's members and support the reproductive and sexual health of women with cancer. More than 800,000 cancer diagnoses are reported among women every single year in the U.S. Those fighting and recovering from hormone-sensitive cancers cannot use hormonal birth control because it may stimulate the growth of tumor cells. Last week, I was honored to deliver a keynote address at the 2021 ENCODA Spring Forum, where I shared the attributes of PheXy as a non-hormonal birth control option for breast cancer survivors like myself. Additionally, we presented two posters on relevant aspects of the phase three Empower trial that are important for oncology professionals and their female patients to consider. On the heels of those presentations, ENCODA published a PQI, a positive quality intervention, in connection with PheXy as a birth control option to educate oncologists, and oncology pharmacy teams who are involved in the care of female cancer patients. We also had a very strong presence at the ACOG annual clinical and scientific meeting last week. We exhibited FEXI for the first time using a virtual exhibit booth, which allowed healthcare providers to learn about FEXI through videos, a self-guided tour, downloadable resources with links to our Everfem Engagement Center to explore our medical fair's virtual platform. Several hundred HCPs visited the virtual booth with strong engagements. The two new data sets from our Phase III Empower trial were presented at ACOG. They provide clinical insights into how women use FEXI in Empower, as well as their feelings about pregnancy, which are very important factors for clinicians to consider when they're counseling and prescribing FEXI. Additionally, we sponsored a CME course at ACOG on the role of vaginal pH modulators in contraception and the implications of current contraceptive trial design on the Creeping Pearl Index. More than 400 ACOG attendees participated live, and we expect that others will listen on demand. Now I'd like to turn to R&D. The CDC released new data last month showing that reported cases of STIs in the United States has reached an all-time high for the sixth consecutive year in a row. There were 1.8 million cases of chlamydia and approximately 600,000 cases of gonorrhea reported in 2019. The CDC cautioned. Anyone who is sexually active can get gonorrhea or chlamydia. And with all 78 million sexually active women in the U.S. potentially at risk for STIs, this is a significant market opportunity. And the need and opportunity are even greater outside of the United States. Our R&D resources are focused on developing EVO100 for the prevention of chlamydia and gonorrhea. And we continue to enroll patients in our Phase III trial EVOGuard. All 90 planned sites have been identified and 80 sites have been activated. We continue to expect to complete enrollment this year, report top line results in the first half of 2022, and assuming positive results to file the NDA for these potential new indications by the end of next year. EvoGuard builds on positive outcomes of our Phase IIb ampervans trial, which met its primary and secondary efficacy endpoints with statistically significant reductions in the risk of chlamydia and gonorrhea. The study was published in the peer-reviewed American Journal of Obstetrics and Gynecology, adding credibility to the outcomes and raising the profile of our ongoing EVOGARD trial. We are committed to completing EVOGARD and gaining FDA approval for these potential new indications as quickly as possible. And I want to switch now to the global opportunities. Our strategy is to out-license commercialization rights outside of the United States. We are currently in discussions with multiple potential partners for various geographies. We look forward to being able to give you more detail in the appropriate time when the ink is dry on the right arrangement with the right partner in a given country or region. In closing, if you look at the contraceptive launches over the past three years and you take a moment to reflect on the data that we shared today on this call, notably the growing awareness of Bexie among women and healthcare providers alike, leading to significant growth. You will begin to understand our confidence in this product and our confidence in this team. Our investments are delivering results. Our strategy is on point and our team is executing. The perfect triangulation between unmet need for non-hormonal contraception, increasing impact of our Salesforce efforts, and our record-setting DTC campaign will shatter the hormone glass ceiling. With that, I'd like to turn it over for Q&A.
spk07: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, please press the pound key. Your first question comes from the line of Ram Selvaraju from HC Wainwright. Your line is now open.
spk06: Hi, this is for Ransal Raju, and thanks for taking my question. And by the way, congrats for the quarter. So could you comment on the prescription transfer that you expect for the year 2021? And moving forward, do you think these prescriptions will be initiated primarily by patients or physicians or a combination of both?
spk05: Yeah. We expect that, as we've already seen in the first quarter, we're going to continue to see the same type of uptake happen around our efforts in terms of prescriptions. As we have continued to grow them, we will see these times, of course, as we pulse out our DTC campaigning, that there are times when There's a little less of an uptick, but we don't see anything that would lead us to believe that we're going to have any change at all in the rapid uptake that it's taking. We have been able to see We're sure that we're getting not only commercial lives covered, but we're also getting Medicaid lives covered, and we're very pleased to see that we have access for PECSI across almost all the platforms, so we have access for women who need to have this fundamental change in their contraceptive availability.
spk06: Understood. So do you think your market research kind of suggests that women the DTC campaign is favoring one target population over the other?
spk05: So actually what we've really seen is that This campaign has been very effective at reaching across the spectrum. You saw that in our campaign we had basically three different types of profiles that we looked at. We looked at the woman who was using a condom, we looked at the woman who was using the pill, and we also looked at the woman who was doing the rhythm method. What we discovered is that when we took a look at the people who are then getting prescriptions, that it covers across the spectrum of both those who are currently using hormonal contraception, those who have not been doing anything, and those who have been using long-term methods of contraception and are in the middle of transition. The good news for us is that makes the pool for Psexy really quite large. And in our research that Sondra referenced, we saw that 75% of women who we went to market research with that are just of the contraceptive age said if there was an acceptable form of non-hormonal, that they would go to it. So we're pleased and excited to know that we have a really wide spectrum in terms of our segments.
spk06: Understood. One final from me. So what changes are you seeing from a market flexibility standpoint, as COVID restrictions are beginning to subside? And if you think, do you think this would contribute to any kind of tailwinds in 2H 2021? Thanks.
spk05: So one of the things that we have began to definitely see is, as an example, we've had a request for a live speaker program for some doctors actually up in the New York area where they want to come together to discover more about Phexxi. And so that's beginning to see that kind of change you would expect to see that has traditionally been the opportunity to have face-to-face interactions. with folks. Our salespeople have been very diligent about making sure they're getting in and getting access in all the right places. Where there isn't access, moving to other places. So we're seeing this groundswell take place that has been very, very encouraging. And that FEXI is in fact gaining that level of not just utilization, but also that measure of stickiness that you would expect to see as you move through this process of women beginning to make FEXI their method of contraception.
spk06: All right, that's it from me. Thanks so much.
spk07: Thank you. Your next question comes from the line of Annabel Cimini from Stevo. Your line is now open.
spk02: Hi, all. Thanks for taking my question, and congrats on getting some improving growth to net. It's actually been a strange quarter. We've seen a lot of our companies improving growth to net this quarter, and usually they're seasonally low. So, I guess what are some of the tactics you use to improve that and what do you expect to do going forward? How many levers do you have to pull to sort of control that before you, you know, may have to give up rebates to payers? So that's the first question.
spk05: Well, the exciting part is as we put our strategy into place, even from launch until this point, and we began to follow this pattern of assuring that we first of all drove demand and interest in Vexy, and then as we started to put into place some of those things, we're confident that our strategy will continue to deliver the results that will improve our profitability. So some of the things that we have been able to do effectively is we've moved ourselves from a place where, We're now asking those offices through assistance with a third party that we've used to put these PAs or prior authorizations through prior to the script being filled. That has a tremendous impact upon our ability to then assure we get that. Here's a really interesting statistic that, as I was talking with the vice president of our market access, we've got about 75% of lives that we estimate are going to be covered by their plans. So that really puts us into a position where we're getting a majority of those access. And so that big change has just allowed us to really increase the level of dollars that we're able to gain from that process because we're no longer covering them irrespective of the PA going through.
spk02: Okay. So are you still following that typical pattern of giving the first prescription with zero copay and subsequent prescriptions for $30? I'm just trying to understand the mechanics there.
spk05: Yeah, we still are currently doing that. And so the mechanics of that, the primary thing that was more at effect that had a bigger effect on the GTM was to allow women who didn't have their PA or their prior authorization go through, get the product. That's where we end up with the biggest change in our GTM. When we put that change into effect. What it really does is it gives us what is a much richer place. And I've heard Jay say this before. He says, you know, we're better off having 750 scripts at a 40 or 50% GTN than we are 1,000 at 80. And that's what we've really implemented at this point. Now that we have enough traction with healthcare providers and women and their interests would be able to do that. But the exciting part, Annabelle, is this, is as we've looked at the PA process, in almost all cases it's really not very rigorous, and physicians have been indicating that working together with the third party that we put in place, one of which more than 80% say that's a familiar group of people to work with, they're really not resisting. In fact, they understand that, as Sandra had said, especially for those women in their practice, and each one of them will have one of them, this year get diagnosed with a cancer, that they have to assure that they're doing their job and their part to make sure this gets pinged at the payer level so that payers recognize there is an unmet need and a large group of women who need to get this. So that's been a part of that strategy that we're doing to increase our GGN.
spk02: Got it. And are there any stats you can give us regarding patients who are going through the concierge services and can you tell us what the refill rates are overall. I guess we're several quarters into this, and at this point we should have some idea of what the refills are.
spk05: Well, one of the things that we've seen definitely, and we call it the concierge experience, I'm going to call it the whole online medical telemedicine portal, is that through the DTC campaign it has increased significantly, multiple times. And not only that, it's also increased the level of what I would say women who are coming to that portal who have a genuine interest because our fill rates are exceptionally high. Now, we really are focused at this stage in the game on our total prescriptions because we think that's the most important thing. FEXI is not a monthly method. A woman uses FEXI when she needs it, she refills it, and it's not measured in the same monthly refill that you would get with other things. So what we're really looking at is I can tell you that the PEC-C refills were significant in terms of what we expected, but our data points, and I want to be very cautious about this, is to recognize our data points are not going to be the same as you would expect to see with a monthly method because it is an on-demand method. So we're still waiting as we gain – significant ramp up in terms of our utilization to understand what the stickiness is in that respect but we've at the same time conducted the market research to ask what's the likelihood of continuation and we're seeing those numbers being the high 80s and even low 90s that say yes my intention is to not only continue but also to share, and we think that's as important of an understanding of what the stickiness is as it is to see those scripts because, as we have indicated, we know that there's a lag in understanding exactly what the frequency is when you're an on-demand method and not a monthly method.
spk02: Got it. And one last question for me. I'm really intrigued by potential penetration into that cancer population. Do you have any metrics around that and how successful – you are in reaching those patients, and if you've been starting to see prescriptions from those types of patients.
spk08: Well, I would say two things, and then, Russ, you can jump in. So we really just began this initiative, meaning that we now have identified through ENCODA what is the right way to educate, communicate, and activate this community. And so we are you know, we want to be mindful. We want our sales force to continue to call in OBGYNs, but frankly, when they are in those territories with the zip codes where there are cancer clinics, we've actually had some very mindful conversations. We have some reps that actually have sold oncology products in their past. So the short answer is that we're beginning to see an uptake now, but I think based on the efforts that we're making with this PQI and the efforts that we are going to continue to drive with the sales force, I think you're going to see a lot of additional growth on top of the growth that we anticipated through the OBGYN community. And the other thing that I would say is when you look at the 800,000 women, I mean, the one thing that we keep saying is, you know, let's remember about the women who were diagnosed last year and the year before and the year before. So these are large numbers of women. And the one thing that we can say that our competitors can't is that this is the only product that they can use on demand with no hormones because there are only other alternatives is a copper IUD. And in our conversations with oncologists, they continuously say to us that after women have been through those kinds of treatments, that the last thing they want to do is give them a product that they can't control, that they suffer from side effects. So the short answer is, is that we don't have any very, very direct metrics at the moment, but on our next earning calls, we do anticipate to be able to break that out much more crisply than we can now, because most of those initiatives just are underway.
spk05: And the only thing I'll add to that is that we are looking to partner with oncology GPOs and such to help educate their physicians as well. And just anecdotally from being in the field, one of the nice things that I heard from an OBGYN is that they say almost always they seem to be at odds with the oncologist. and this is the first time that they feel like they're now going to be able to be on the same page for those women who are not only being treated at the oncology office but have been their patients and will continue to be their patients after they've, you know, got through their cancer treatment. So there's an excitement on the OBGYN side as well about the fact that now even those patients that go to the oncologist are going to have something that they too can support.
spk02: Got it. Thank you so much. I'll follow up later with others.
spk07: Thank you. Your next question comes from the line of David from Piper Sandler. Your line is now open.
spk01: Hey, thanks. So I just got a couple, and I joined late, so I apologize if you already addressed this. But on the unique pregnancy category, can you just talk about that in terms of where that And then I'm also interested in portion of covered lives that are now covered at zero copay and where you expect that to be, say, by the end of 2021. So that's number one. And I wanted to ask, secondly, a longer-term question. And maybe this is real early to ask the question, but, you know, you have commercial infrastructure in place. So as you get further into the FECSI launch, do you start to keep a closer eye on opportunities to bring in another asset that can leverage your infrastructure? How much of that will be a priority as you get more and more into the launch and FECSI has more of its footing in the marketplace? Thank you.
spk08: Yeah, hi, David. So one of the things, I want to start with your second question and then go back to your first if that's all right. So I would tell you this, that as realist as our whole company is, we definitely recognize that the cost of the sales force is not nominal. The one thing, though, that we continue to be certain of without question is having our own sales force completely committed to this asset and this launch being directed, being paid for, and being incentivized by us is the right decision, no question. And we have our ability to train them and retrain them and re-motivate them in a way that is very continuous and ongoing, and we still feel very bullish about that decision. However, we do recognize that, you know, sales teams get to a point where they want another asset. The strange part is that with COVID, Because now things are opening up, it's almost like now they're seeing offices where they weren't able to see before. So there's not a level of boredom yet, thank goodness, and they are actually continuing to grow their base of people that they can see an impact. So we feel like we're going to continuously grow the FECSI brand for the rest of this year. Now, we do, as you know, forthcoming with our addition of Chlamydia and Gonorrhea and Feel like that's also going to continue to grow market share for sexy right all that's going to be able to do is, you know, build the base. So we feel good about that. But I guess the short answer is yes, we most definitely are constantly looking at assets would be a fit in the right call point to You know, the great thing is that I think people are recognizing that we have the right team, meaning we understand how to market to these women. We understand how to talk to these physicians. We understand the managed care obstacles and pitfalls as well as ways to get around them. And so we have opportunities to talk to a lot of companies that may be don't have the financial resources or they don't have the commercial expertise to build their own team. So we are very interested. We are continuing to look. We haven't yet identified that right product yet, but I can tell you that from a business development standpoint, that is a very assertive and ongoing process. And we'd love to add the right product to the bag. Now, as of your first question, I'm assuming you're talking about ACA and getting the new category so that we can have vaginal pH modulator. Is that right? You want us to address that?
spk01: That's exactly right, yes.
spk08: Yes. So did you have a comment, Russ, you wanted to share or you want me to take it? David, just so I'm clear, though, do you want to know what our expectations are or what the process is? Just so I answer your question directly.
spk05: Both. Were you online when Sandra talked about that? Just so we don't do too much repeating on that, you might have missed that part as you suggested that you came on late.
spk01: Okay. So I guess just maybe on the copay front, I mean, what portion of Covered Lives are at zero copay? Just remind me again.
spk05: Now at zero copay we have, I think it's somewhere in the neighborhood of 8%, somewhere in that ballpark. But the more important thing is we've got roughly about 75% of all of our claims are going through unrestricted. And so that's probably the more key part of that potential. And then as Sandra had said, in terms of the ACA, there really has never been, I don't think, the same heavy lift that's going on towards getting this category. And that's largely, David, because every person, and I mean that with 100%, every person that we have spoken with who are advocates for women have said this should be its own category. Every politician that we've spoken with has said this should be its own category. There haven't been one exception to that of people who are really advocating for women who have said, well, you know, this is a me too. They all recognize that there is nothing for these women and they believe that it should be out there. So we do hold a lot of, of hope and confidence that the efforts that we are taking will be fruitful and it won't be the same as others who would like to try to get a category of something that already exists in this market because ours doesn't.
spk08: Well, and the one thing, David, as you probably know very well is is that when we're successful, it really is like a light switch, right? If we're successful, we have our own vaginal pH modulator category, then one product in every category is covered. We will obviously be the only product in that category. Now, the tough part, I mean, we were approved last May. So we have been talking to the Office of Women's Health in a very professional and appropriate and civilized way in the beginning because we accepted that COVID was a priority for everybody. But the call today the reason that we wanted to share with everybody all of the advocacy groups and all of the political people that we've talked to including Aaron Brockovich is that we wanted everybody to understand that this we are being very aggressive far beyond assertive and we are confident that those efforts are going to pay off and the reason that we're confident though is that we've been very careful to say this is about the vulnerable women who cannot use any other method. And there are some plans, by the way, that say to women they have to fail on eight or nine products before they're given access sometimes. And so once that information is shared, people are aghast, by the way, and they come back and say, look, the fact that this is a new innovation that women use on demand with no hormone and there is nothing else like it, just for that cancer population alone or clinical contraindicated women, is enough to get all of these people really pushing it. That's why we feel good. Now, by the way, we recognize that some of our other companies that are in women's health, they also want their own category, and we don't blame them. But the reason we think our chances are, frankly, better is because we speak to a vulnerable population of women that no one else can speak to. That's why we feel confident we're going to be successful.
spk07: Okay. Thank you. Thank you. This concludes today's question and answers period. I will now turn the call back to Sandra Pelletier.
spk08: Thank you. I want to thank everybody for joining the call today and for standing with EvoFem as we continue successfully marketing Phexy for hormone-free contraception. Also, as we develop EVO 100 for the prevention of chlamydia and gonorrhea in women. And we're confident that we are very well positioned to achieve our goals and to build value for women and builds value for shareholders alike. We look forward to sharing more information with you on our next call, and thank you again. Have a great rest of your day.
spk07: This concludes today's conference call. Thank you for participating. You may now disconnect.
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