Evofem Biosciences, Inc. (OTCQB:EVFM) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET
Amy Raskopf - Vice President of Investor Relations
Saundra Pelletier - Chief Executive Officer
Jay File - Chief Financial Officer
Russ Barrans - Chief Commercial Officer
Conference Call Participants
Boobalan Pachaiyappan - H.C. Wainwright
Annabel Samimy - Stifel
David Amsellem - Piper Sandler
Good day, and thank you for standing by. Welcome to the Evofem Biosciences First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]
I would now like to hand the conference over to your speaker today, Amy Raskopf. Please go ahead.
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 Saundra Pelletier, Evofem's CEO.
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 Phexxi DTC campaign, which we launched nationwide on Valentine's Day. Due to the immediate success of this multi-channel marketing campaign and our sales forces' persistence during these challenging times to access healthcare providers, we reached new highs across all metrics, including Phexxi total brand awareness, total prescriptions, prescriber base growth and most importantly, revenues. We expect this campaign will continue to drive consumer awareness and utilization of Phexxi 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 Phexxi as a vaginal pH modulator on the FDA's contraceptive categories chart, our collaboration with NCODA to raise awareness of Phexxi in the oncology community, gross-to-net improvement strategies that are already having a positive impact on our operating results and discussions with potential partners for commercialization of vaccines in multiple geographies outside of the United States. I'll discuss these initiatives and our expectations for Phexxi and our Phase 3 STI prevention clinical trial after our CFO, Jay File, reviews the financial results; and Russ Barrans, our Chief Commercial Officer, discusses DTC impact.
Thank you, Saundra, 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 6 weeks of sales following the Get Phexxi DTC campaign launch. Compared to Q4 2020 levels, gross revenues increased 293% driven by strong growth in ex-factory units shipped. 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 around the remainder of the year, driven by a series of GTN improvement strategies that we began implementing in April as far as our overall strategy to build Phexxi 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 - due to primarily clinical trial expenses for EVOGUARD and personnel costs. Selling and marketing costs were $30.5 million, reflecting the commercialization of Phexxi, including media, advertising, and public relations expense and sales force costs. And general and administrative costs were 7.1 - $7.7 million, excuse me. Cash and cash equivalents was $45.3 million at March 31, 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 underwriters' over-allotment option in conjunction with the March rates.
With that, I'll turn it over to Russ for more detail on the commercialization efforts.
Thank you, Jay. As Saundra mentioned, we launched our direct-to-consumer campaign, Get Phexxi on Valentine's Day and the impact has been significant. Overall, Phexxi brand awareness tripled to over 12% in March and we saw a 63% increase in women's interest in Phexxi between January, which was the last full month before the DTC campaign and March, our first full month after the Get Phexxi launch. In just a few short months, Phexxi'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 in 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 have - of Phexxi increased 98% in that same time period.
Based on market research that was conducted in the March end, and let me say, this is really quite significant. 93% of women who discuss 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 4 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 products like IUDs and implants. Market research, and now, of course, real world experience shows that this very significant group of women, like, for example, Pill Pia 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 Get Phexxi 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 FiercePharma for recognizing Get Phexxi in the FierceMadness DTC competition, alongside other ads from large pharma, including J&J, Bayer and Moderna. Our second place finished by the slimmest of margin, it's actually just a vote. It is a personal point of pride and further demonstrates how appealing Get Phexxi has been and how much it resonates with our audience.
If I can, I wanted to touch quickly on just some of the future promotional efforts that are going to take place. Well, I'm not going to share very minute 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 Phexxi awareness to record-setting heights. Now, you may have noticed, more likely, if you are in our target audience for Phexxi, that several weeks after Get Phexxi launched, you stopped seeing the ads during your evening cable TV and you were right. We are using a proven model whereby TV and video media content are paused in certain cadences and instead of just running it in a predictable sequence, anything that becomes predictable, becomes white noise. So we strategically put placement 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 Phexxi. We are currently working with many different Instagram influencers, who have more than 3 million followers in aggregate. Last month on Phexxi's Instagram, we also debuted Unfiltered, our new monthly Phexxi 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 1 video per month providing her expertise as an OB-GYN and there is 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 Saundra, I want to summarize. Q1 was a great quarter from a commercial perspective marked by significant accomplishments and including exponential unit sales and prescription growth, the launch of the Get Phexxi 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 Saundra.
Thank you, Russ. I'm now going to focus my comments on 3 key areas of our business today, ACA, partnerships and our pipeline. We currently have Phexxi coverage for the 55% of commercial lives in 100% of the Medicaid population. Our Medicaid agreement took effect on January 1 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 contract with the PBM, because we are confident that we will succeed in gaining a new category for Phexxi as the 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 Ricchetti, 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 HELP 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 HELP Committee and on the Senate Appropriations Committee; Senator Tammy Baldwin, also serving on the HELP Committee and on the Senate Appropriations Committee; Senator Maggie Hassan, also serving on the HELP Committee; Senator Ben Cardin, who serves as the Senate Committee on Finance and the Subcommittee on Health Care and our own San Diego representative; Scott Peters, who serves on the HELP Budget Committee.
Among women's health advocates, we have spoken with many influential groups, who share our conviction 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, NCODA, 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 Phexxi 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 Phexxi. When a woman cannot use a hormone, she should not be denied access to the only on-demand hormone-free prescription drug 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 6 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, NCODA, it was to raise awareness of Phexxi among and NCODA's members and to 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 NCODA Spring Forum, where I shared the attributes of Phexxi as a non-hormonal birth control option for breast cancer survivors like myself. Additionally, we presented 2 posters on relevant aspects of the Phase 3 AMPOWER trial that are important for oncology professionals and their female patients to consider. On the heels of those presentations, NCODA published a PQI, a positive quality intervention in connection with Phexxi 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 Phexxi for the first time using a virtual exhibit booth, which allowed healthcare providers to learn about Phexxi through videos, a self-guided tour, downloadable resources with links to our Evofem engagement center to explore our medical affairs virtual platform. Several hundred HCPs visited the virtual booth with strong engagement. The 2 new data sets from our Phase 3 AMPOWER trial were presented at ACOG. They provide clinical insights into how women used Phexxi in AMPOWER as well as their feelings about pregnancy, which are very important factors for clinicians to consider when they're counseling and prescribing Phexxi.
Additionally, we sponsored a CME course at ACOG on the role of vaginal pH modulators in contraception and the implication 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 cautions 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 3 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 topline 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 2b AMPREVENCE 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 & Gynecology, adding credibility to the outcome and raising the profile of our ongoing EVOGUARD trial. We are committed to completing EVOGUARD and gaining FDA approval for these potential new indications as quickly as possible.
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 at 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 3 years and you take a moment to reflect on the data that we shared today on this call. Notably, the growing awareness of Phexxi 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 sales force 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.
[Operator Instructions] Your first question comes from the line of Ram Selvaraju from H.C. Wainwright.
This is Boobalan dialing in for Ram Selvaraju. And by the way, congrats for the quarter. So could you comment on the prescription trends for Phexxi that you expect for the year 2021? And moving forward, do you think this prescriptions will be initiated primarily by patients or to physicians or a combination of both?
Yes. That's - so 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 put out our DTC campaign, that there are times when there is 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 update of the patients. We have been able to see for 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 Phexxi across almost all the platforms. So we have access for women who need to have this fundamental change in their contraceptive availability.
Understood. So do you think your market research kind of suggests that the DTC campaign is favoring one target population over the other?
So actually what we have really seen is that this campaign has been very effective at reaching across the spectrum. You saw that in our campaign, we had basically 3 different types of the profile that we looked at. We looked at the woman who is using a condom, we looked at the woman who is using the pill and we also looked at the woman who is doing the rhythm method. What we've discovered is that when we took a look at the people who are then first getting prescriptions, that it covers across the spectrum of both those who are currently using hormonal contraception, those who are - not been doing anything and those who have been using long-term methods of contraception are in the middle of transition. The good news for us is that makes the pool for Phexxi really quite large. And in our research that Saundra 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.
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?
So one of the things that we have begun 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 both. Our sales people have been very diligent about making sure they're getting in and getting access in all the right places, where there isn't access and moving to other places, so we're seeing this groundswell take place that has been very, very encouraging, and that Phexxi is in fact gaining that level of not just utilization, but also that measure of stickiness as you would expect to see as you move through this process of women beginning to make Phexxi as their method of contraception.
Your next question comes from the line of Annabel Samimy from Stifel.
Congrats on getting some improving gross-to-net. It's actually been a strange quarter, we've seen a lot of our companies improving gross-to-nets this quarter and usually, they're seasonally low. So I guess, what are some of the tactics used 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 may have to give up rebates to payers? So that's the first question.
So the exciting part is, as we put our strategy into place even from launch till this point and we began to follow this pattern of us assuring that we first of all, drove demand and interest in Phexxi, 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 as we've moved ourselves from a place where we are now asking that 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 on our ability to then assure we get that. Here is a really interesting statistic that, as I was talking with the Vice President of our Market Access that, we've got about 75% of lives we estimate are going to be covered by their plans. So that really puts us into a position where we're getting majority of those access and so that big changes 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.
Okay. And so, are you still following that typical pattern of giving the first prescription with 0 co-pay and subsequent prescriptions for $30? I'm just trying to understand the mechanics there.
Yes. We still are currently doing that and so the mechanics of that - the primary thing that was more at effect - they had a bigger effect on the GTN was to allow women, who didn't have their PA or their prior authorization go through, get the product. That's how we end up with the biggest change in our GTN. 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 is that we're better off having 750 scripts at a 40% or 50% GTN than we are 1000 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 interest, we're be able to have - but the exciting part, Annabel, 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 Saundra had said, especially for those women in their practice and each one of them will have one of them that this year get diagnosed with a cancer is that they have to ensure that they are doing their job and their part to make sure this gets pinged at the payer level, so the 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 GTN.
Got it. And are there any stats you can give us regarding patients who are going through the concierge services, and can you tell what the refill rates are overall? I guess we're at several quarters into this and at this point, we should have some idea of what the refills are.
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. Phexxi is not a monthly method, a woman uses Phexxi when she needs it, she refills it and it's not - so that's not measured in the same monthly refill that you do with other things. So what we're really looking at it is, I can tell you that the Phexxi refills were significant in terms of what we expected but our data points - and I want to be very cautious about this, is the recognized - our data points are not going to be the same as you would expect to see as a monthly method, because it is an on-demand method. So we are 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 to be in 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 is a lag in understanding exactly what the frequency is when you're on-demand method and not a monthly method.
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 on reaching those patients? And if you've seen - been seeing - starting to see prescriptions from those types of patients.
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 NCODA what is the right way to educate, communicate and debate this community, and so we are - we want to be mindful, we want our sales force to continue to call an OB-GYN, 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 actually some respite actually who have sold oncology products in their past. So the short answer is, 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 OB-GYN 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, 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 is that our competitors can't is that this is the only product that they can use on-demand with no hormones, because their only alternative 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 that we don't have any - very, very direct metrics at the moment, but on our next earning call, we do anticipate to be able to break that out much more crisply than we can now, because most of those initiatives are still underway.
And the only thing I would add to that is, that we are looking to partner with the 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 OB-GYN is that they say almost always they seem to be at odds with the oncologists 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 that are - have been there - their patients and will continue to be their patients after they've got through their cancer treatment. So there is an excitement on the OB-GYN side as well about the fact that now even those patients that go to the oncologists are going to have something that they too can support.
Your next question comes from the line of David Amsellem from Piper Sandler.
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 stands? And then, I'm also interested in portion of covered lives that are now covered at 0 co-pay and where you expect that to be, say, by the end of 2021? So that's #1. And I wanted to ask, secondly, a longer-term question and maybe this is real early to ask the question, but you have commercial infrastructure in place, so as you get further into the Phexxi 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 Phexxi has more of its foot in the marketplace?
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 a realist as our 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 enough, 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 the sales teams to 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 is not a level of boredom yet, thank goodness. I mean, they are actually, continuing to grow their pace of people that they can see and impact. So we feel like we're going to continuously grow the Phexxi brand for the rest of this year. Now we do, as you know, forthcoming, with our addition of chlamydia and gonorrhea, feel like that's also going to continue to grow market share for Phexxi, right? All that's going to be able to do is 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 that would be a fit in the right call point. Two, 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 a lot of companies that maybe 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 right - add the right products in that now. Now as of your first question, I think - 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?
That's exactly right. Yes.
Yes. So did you have a comment, Russ, you wanted to share or you want me to take it? Well, 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.
And then, were you online when Saundra 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.
Okay. So I guess, just maybe on the co-pay - on the co-pay front, I mean what portion of covered lives are at 0 co-pay? Just remind me again.
Now, at 0 co-pay, we have, I think it's somewhere in the neighborhood of 8% and 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 Saundra had said in terms of the ACA, there really has never been, I don't think, the same heavy lifted 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 hasn't been one exception to that of people who are really advocating for women who have said, well this is a Me too and 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 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.
Well, and the one thing, David, as you probably know very well, is that when we're successful, it really is like a light switch. If we're successful, we have our own vaginal pH modulator category, then 1 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 civilized way for - in the beginning, because we accepted that COVID was the priority for everybody, but in 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 Erin 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 8 or 9 products before they are 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, is that - 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.
Thank you. This concludes today's question-and-answers period. I will now turn the call back to Saundra Pelletier.
Thank you. I want to thank everybody for joining the call today and for standing with Evofem as we continued successfully marketing Phexxi for hormone-free contraception. Also, as we develop EVO100 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 build 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.
This concludes the conference call. Thank you for participating. You may now disconnect.