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spk04: THE END Ladies and gentlemen, thank you for standing by, and welcome to the ABLE-FEM Biosciences Third Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To participate in that portion of the call, you will need to press star 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star and zero. I will now hand the conference over to your speaker today, Amy Raskos, EvoFem Biosciences, Head of Investor Relations. Ma'am, please go ahead.
spk03: Thank you, and good afternoon, everyone. If you haven't done so already, I encourage you to access the slides which accompany today's call and the press release we issued earlier this afternoon, 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, November 9, 2020. 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, our most recently filed 10-Q, and our current report on Form 8-K, filed with the SEC on June 2 of 2020. With that, I'll turn the call over to Sandra Pelletier, FOM's CEO.
spk05: Thank you so much, Amy. Hello, everyone. Thank you for joining us this afternoon. In the second half of 2020, Avofem has achieved three significant milestones. In September, we launched Vexxy, the first and only non-hormonal prescription contraceptive drug for on-demand use. In October, we closed a $25 million strategic investment from Adjuvant Capital. And we initiated our pivotal phase three trial of EVO 100 for the prevention of chlamydia and the prevention of gonorrhea in women. On September 8th, we announced the commercial launch of Phexy. Despite the challenges we faced launching a commercial product in the midst of COVID-19, we are proud of our early momentum and we're confident about the long-term success of Phexy. Considering that there are 21 million women in the United States who are beyond hormones, FEXI has conservatively a billion-dollar market opportunity. In fact, so listen to this part. If we can just acquire 3% of these 21 million women, that's just 630,000 women out of the 21 million that are already beyond hormones, and they fill their prescription seven times in one year, we will achieve this potential. Once again, this illustrates that small percentages of market share will deliver very big results for FECSI. Our reported earnings represent only a small snapshot of our commercial launch, which is now only two months in. And Russ Behrens, our chief commercial officer, will discuss later on the call our early indicators that support a strong growth trajectory and gets us well above that conservative figure. Our extensive consumer brand awareness campaign has leveraged the targeted digital channels and key influencers to raise awareness of Phexxi with a diverse and engaged consumer audience. Our early adoption of telemedicine has provided women with expanded access to Phexxi without the need and without the hassle of a physician office visit. And we are especially proud of our team's ability to implement the Phexxi Concierge Experience, which is our comprehensive online experience for women seeking to gain access to contraception. In this business, an unwritten rule is that you take good capital when you get it, at the right cost and from the right party. For well over a year, we built a strong relationship with Adjuvant Capital. They are backed by the Bill and Melinda Gates Foundation and other global public health leaders like Merck and Novartis. Adjuvant is deeply aligned with our core mission, developing and commercializing innovative products to address critical sexual and reproductive health concerns of women. Their $25 million investment was at a premium to the market on the date of close, as well as a premium to the fundraising round we completed in June. This is Adjuvant's largest single investment to date. What is important is that what that testifies to is the confidence that they have in this team and the importance of introducing true innovation in women's health, not just Me Too products in crowded categories. For Ebofem, And for our shareholders, this was a very smart strategic move. The thing that I want investors to hear, though, that's very important is that the lion's share of the adjuvant investment is earmarked to fund the development of EVO 100 for the prevention of chlamydia and gonorrhea in women. We enrolled the first patient in our pivotal Phase III trial in mid-October, in line with our stated timeframe. And we met our enrollment target for the month of October in just nine days. So we are very confident that even in the COVID environment, we will not have any issues enrolling in this trial. There is nothing FDA approved for the prevention of chlamydia and gonorrhea, and every woman having sex is at potential risk. The reality is that partners are unpredictable, and that's sad, but it is true. And condoms break, and many times women don't win the condom negotiation, and therefore they're not even used. So the increasing prevalence of these STIs in the U.S. and globally attests to the growing unmet need. EVO 100 has the potential to be the first drug approved for the prevention of these common STIs, and many investors think this will be an even bigger opportunity for us than contraception. In addition to our drive for innovation, which as you have seen, is going to be threefold. First, with the only non-hormonal contraceptive product that women use on demand, Then with the prevention of chlamydia and gonorrhea, we continue to differentiate ourselves, and we're also differentiated by our culture, which enables us to attract, to grow, and to retain top talent at every level in every department. Investors have the confidence that we not only have a game-changing product, but we have a superior team to execute. So what do those adjectives really mean? What do I really mean when I say superior? What I mean is that all of the people in our commercial organization have surely worked on the biggest products in contraception, delivering very big results because they know how to maneuver through hurdles. They know and understand how to make these products rise to the top of the mind for both women and for doctors. Our sales team alone is second to none. As we've said before, but I want to say it again, they have an average of eight years of women's healthcare experience and 15 years of pharma. Their ability to call on long-standing relationships in the industry is has provided invaluable resources, particularly now during the FECSI launch, because there's many offices that are closed due to the pandemic. So I do want to tell you with full confidence, you will not find a better team to make FECSI a commercial success. We are an organization that inspects what we expect. We have very close, very consistent, and constant interaction with the payer teams and the commercial teams. Just Friday, we had an incredible call with the entire sales organization. The purpose was to share success stories, to talk about how to overcome obstacles, and to get feedback. And I want to tell you that these reps have launched not just one, not two, sometimes three, four, and five contraceptive products in these same categories. And the stories that we hear from them are unbelievably unique and different. And many of them say that they have never seen this kind of response from offices. And these are people who would know better, and they know different. And we are sobering realists here, and we say, look, we do not want to just know about the rainbows and the puppy dogs. We want to know about the warts. And so it's very encouraging to see that once these reps have an opportunity to talk to doctors and offices, it is very easy for them to see who these fexy patients are. So as I turn the call over to Jay Feil, our CFO, to review the results of the third quarter, I want to highlight that this includes our first-ever revenues which are from just the initial three weeks of the FEXI sales. Then Russ will talk in greater detail about the FEXI commercial launch and the early trends in the marketplace, which, frankly, are very positive. And Kelly Caldwell will give a clinical update, and then we will open the call for questions. So with that, Jay?
spk07: Thank you, Sandra. For the three months ended September 30, 2020, which included those first three weeks of FEXI sales, we recognized 278,000 in net product sales. This was from the initial stocking of FECSI by wholesalers and specialty pharma customers adjusted for distributor fees, co-pays, and other related items. Cost of goods sold was 317,000, which included a 100,000 one-time charge related to the product label. Research and development costs decreased to 4.2 million in the third quarter of 2020. The decrease reflects an absence of costs for the FECSI NDA and the F-Revents trial in the current period. This was partially offset by clinical trial expenses for EvoGuard, which we initiated in October 2020, and higher payroll-related expenses, non-cash stock-based compensation due to increased headcount in the current period. Selling and marketing costs were $14.7 million in the third quarter of 2020, compared to $3.8 million for the third quarter of 2019. We started breaking out this line item in 2020 in anticipation of the FECSI launch and for the prior year, reclassified $3.8 million from G&A into sales and marketing expense to conform with this presentation. The vast majority of the $10.9 million increase was related to the FEXE launch. General and administrative costs increased to $7.2 million in the third quarter of 2020, mainly reflecting an aggregate increase of $2.9 million over the prior year quarter associated with various operational items. As a result, Total operating expenses were $26.4 million for the third quarter of 2020, as compared to $14.3 million in the prior year period. Total other expense was $3.7 million in the third quarter of 2020, and mainly included a $3.1 million non-cash change in fair value of the Baker Notes and $700,000 in accrued interest expense related to those notes. As a result, net loss attributable to common stockholders was $29.9 million, or a loss of $0.37 per share for the quarter ended September 30, 2020, as compared with a net loss of $13.8 million, or $0.30 per share for the prior year quarter. We closed the quarter with $86.7 million in unrestricted cash, and as Sandra mentioned in October, we raised $25 million from adjuvant capital. This provides us with one runway into the second half of 2021 based on current expense forecasts and cash firms. And I want to highlight, FEXI revenue provides upside to this forecast. With that, I'll turn it over to Russ.
spk06: Thank you, Jay. FEXI is off to a strong start. Right out of the gate, healthcare providers started writing FEXI prescriptions. In the third quarter, which includes only the first three weeks of data, FEXI was able to achieve 385 prescriptions, and we had our first refill before the quarter closed. I look forward to sharing more robust data on our Q4 earnings call in March when we'll have a full quarter plus of data to share and to give us a better idea of the launch trajectory. Among the many early indicators of interest in FEXE are two that I specifically want to highlight. First, when you look at women who have entered through the FEXE concierge experience and qualified as a candidate for FEXE, 43% of these women booked an appointment through our telemedicine provider to discuss receiving a PECSI prescription. The PECSI concierge experience provider, Populous Media, had projected based on their experience and metrics from their prior launches that the conversion rate would be 22%. The PECSI prescription conversion rate is double these projections. In fact, The Populous COO noted that FEXI is their most successful launch to date and that several thousands of women have come into the FEXI experience in just the first eight weeks since launch. Second, we're working with 83 Bar Social Media to specifically utilize their proprietary artificial intelligence to identify women who may be more interested in non-hormonal contraception in order to offer them an opportunity to learn more more through a nurse support service. Before the PECSI launch, the 83 bar data metrics suggested they would be able to generate approximately 200 leads per month right from the beginning. They blew that number away with 200 in the first four days. They have consistently generated over 200 leads per week, four to five times higher than they anticipated since the beginning of this initiative. Over 2,300 leads have entered the FEXI concierge experience to date through 83BAR. Of all these women that they have reached out to, 30% have engaged with 83BAR regarding FEXI. Approximately 75% of those highly qualified leads have spoken with one of the FEXI support nurses and requested to see an HCP to determine if FEXI prescription is right for them. Another indicator of overall interest and awareness of Phexie is the high volume of website traffic at both our consumer and our healthcare provider websites for Phexie. On the consumer side, www.phexie.com, we are approaching nearly half a million visits since the launch on September 8th. And weekly page visits consistently indicate that these women are not just entering on the landing page and leaving. they're finding out more information about Phexxi by visiting multiple pages. And on the HCP site, we've had more than 31,000 unique visitors by the end of October. And again, each one visiting on average two pages indicating that HCPs are seeking more information on the prescribing of Phexxi for their non-hormonal contraception candidates. A great deal of interest has also been generated through social media influencers, particularly on Instagram. Now, Unlike typical celebrities, we are working with women who have followers identifying with them who are more likely to be swayed to find out more information about Vexxy. Among these Vexxy influencers, a woman named Becca Martinez with more than 660,000 followers. Becca was on The Bachelor and today she has two children and isn't sure if her and her husband are really ready for number three. Our followers tend to be exactly the same. where her followers are in regards to attitudes and their stage of life. Our influencers are equally influential with the other audiences that follow them. They periodically discuss their own contraception journey, and they share stories about Phexie with their followers. Our influencers have 3.6 million followers in aggregate, with the biggest majority of these women are in our target audience for Phexie. Turning our a focus to the Salesforce efforts. Our sales team has succeeded in detailing PECTI to over two-thirds of our target HCP audience thus far. This underscores the caliber of the team we hired. Good reps will find ways to see healthcare providers even in the midst of challenging times. So, while there has been roughly a 30% decline in offices that are willing to let salespeople enter into the office, Based on the COVID-19 situation, we are getting creative in reaching our targets. For example, one of our teams in Florida brings an ice cream truck to the parking lot in front of the OBGYN offices. Everyone's able to leave the office, come out to the truck for ice cream, and while they're there, our representatives discuss FEXA with the entire staff of HCPs and office personnel. Another really creative approach we've used is conducting outdoor virtual speaker programs. We serve lunch to the attendees at distance tables, of course, with the speaker presented on a large bulb screen. These events are extremely well attended, and they really result in very quick awareness of FECSI. As the weather turns colder in the north, trust me, our sales team will continue to find creative ways to gain access to HTPs. At LFM, we are determined to be COVID-proof in getting out the awareness of FEXI. Turning to market access, we currently have over 55% of commercial lives that are covered by FEXI. Our current coverage includes approximately 7 million lives that are covered at zero co-pay, zero deductible, by prominent payers such as UnitedHealthcares of New York, Connecticut, Delaware, D.C., Illinois, Maryland, Massachusetts, Oregon, Washington, and California. It includes Kaiser of Washington State. It includes Primera, Blue Cross Blue Shield, Excellus, Tufts Healthcare Plan, Harvard Pilgrim Healthcare, Quartz Health Solutions, Geisinger Health, Health Now, Blue Cross Blue Shield of Western and Eastern New York. When you look at this level of coverage right out of the gate for women's health products, what this indicates is that payers recognize the uniqueness of FEXI and the unmet need of the existing 21 million plus women who are beyond hormones. We continue to work with the Office of Women's Health and the Health Resources and Services Administration, or HRSA, to update their birth control tables to include VEXI as a new birth control option with a unique mechanism of action as a vaginal pH modulator. The timelines for a decision are unpredictable, but we remain confident that VEXI meets the threshold of a new MOA, as has been recognized earlier by the pricing compendiums as well as these payers I've already mentioned from across the country. I want to conclude with a look at the market opportunity for PEXI. Among the millions of women in the United States who are at risk for pregnancy, and importantly, unintended pregnancy, there are three distinct segments we will target for PEXI. Our primary segments are, first, women using no contraception at all, and also these women who are using non-prescription contraception, such as barrier methods, withdrawal, or periodic abstinence. Our second segment, or as some might say, later adopters, are women who are currently using a prescription contraception, but who may already be considering moving to a hormone-free, on-demand method. FEXI's peak revenue potential is $1.4 to $2.3 billion by achieving only single-digit acquisition percentages of women in each of these three segments. Based on our early indicators of a positive trend and our planned DTC campaign, which will be launched at the end of January, we are confident we can achieve PECSI's full potential. And with that, let me turn it over to Dr. Kelly Caldwell, our Chief Medical Officer.
spk10: Thank you, Russ. As Chief Medical Officer of EBOFM, I am biased. I am clearly a fan of PECSI. But it's not because of my job. It's not because I was an investigator in a PECSI clinical trial. It's because I am an OBGYN who still sees patients, granted, only once or twice a month, but enough that I remain connected to the women that Evofem aims to serve. I understand from a practical perspective who the sexy woman is. I have firsthand experience with women who do not want hormones and who will not use an IUD. I have seen their dissatisfaction leaving my office with a bag of condoms and, frankly, As a provider, I was also dissatisfied with the lack of appropriate contraceptive choice before FEXI. The most effective contraceptive method is the one a woman will use consistently and correctly. This is not a marketing message. This is reality. Women have access to a great deal of information, and today more than ever, they are proactively driving the dialogue about contraception. As an OBGYN, it's not my place to tell a woman what to use. I helped her define the option that she will use. I'm excited that healthcare providers like me can now offer women a new FDA-approved, hormone-free, on-demand contraceptive method, FECSI. Turning to medical affairs, we continue to have great traction with our publication and presentation strategy. We secured nine scientific presentations on datasets from mPOWER, which was our Phase 3 contraception trial, and on mPrevent, which was our Phase IIb STI prevention study, at five key medical society meetings this fall. For AmPower, this included poster presentations at the Society for Family Planning Annual Meeting 2020, where we were the sole sponsor of the poster hall, the Nurse Practitioners in Women's Health 23rd Annual Women's Healthcare Conference, the American Society for Reproductive Medicine 2020 Scientific Congress, and the American College of Obstetricians and Gynecologists Virtual Conference. AMP-Revents publications included an oral presentation at the American Society for Reproductive Medicine 2020 Scientific Congress on sexual satisfaction data in the trial. Additionally, the full AMP-Revents results were presented in a poster at the US CDC's STD Prevention Conference. And a poster on the impact of product adherence and condom use rates on rates of urogenital reinfection with chlamydia and gonorrhea in AMP-Revents were presented at the Society for Family Planning Annual Meeting 2020. Additionally, Two abstracts on sexual satisfaction in these trials were published in Fertility and Sterility, and the full AMPOWER manuscript was published in Contraception. We aim to have the full AMPREVENTS manuscript published in the coming months and are working on submissions for spring conferences. On the clinical side, as Sandra mentioned, we initiated our pivotal Phase III trial for EVO100 for the prevention of chlamydia and gonorrhea in women. This trial will enroll 1,730 women at 90 U.S. study centers. Specifically, we are enrolling women who have had and been successfully treated for a urogenital chlamydia or gonorrhea infection at any time over the 16 weeks prior to their enrollment visit and who have had one or more risk factors for infection. They will receive EBO 100 or placebo with instructions to use study drug immediately before or within one hour before having sex for the four-month treatment period. In terms of timing, we expect to complete enrollment by the end of 2021 and to report top-line results in the first half of 2022 with an NDA submission plan for late 2022. Also, I want to remind everyone that EVO 100 has been granted fast-track designation for the prevention of chlamydia in women by the FDA and is an FDA-designated qualified infectious disease product for the prevention of gonorrhea in women. So, we would expect a priority review with a PDUFA date in mid-2023. And with that, operator, we'd like to open the call for questions.
spk04: Thank you. And as a reminder, ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, simply press the pound or hash key. One moment while we compile the Q&A roster. Our first question is from David Amsalam with Piper Sandler. Please go ahead. David, please check your mute button. Okay, our next question is from Jeff Holm with Morgan Stanley. Please go ahead.
spk01: Thanks for taking the questions. Now that Flexi has been on the market for a couple months, can you talk about the dynamic for scripts being written and filled? So are these scripts being driven more by inbound requests from patients, or are physicians more actively recommending FEC-C to patients? And I kind of appreciate any color you can provide on this dynamic, and then I have a follow-up.
spk06: Yeah, thanks. So, of course, some of our... metrics are still a little bit early in the mix to do that. We're currently in the process of doing an ATU, or Attitudes Trials and Utilization Market Research Project, and we'll have more information for you later on that. But what we do know is that we are seeing about A pretty even mix between those that are coming through on our telemedicine portal, which is an indication that they're following it through their social media or through the other avenues to find out about it, and then the other half are coming through. the healthcare provider. We think most of those healthcare provider ones are coming through based on the fact that once that healthcare provider has learned about it, they are then finding women that come into their practice or that they've already identified that are good options for FECSI and then making sure that they are aware of it and have an opportunity to get a prescription. Great.
spk01: And then can you talk about the refill process? When a woman gets the initial prescription, does the physician include a certain number of refills in that script? And I know it's a bit early and timing can vary, but can you talk about what you're hearing on the proportion of patients who are getting refills? Thank you.
spk06: Yeah, you know, we're seeing it being written in a few different ways. Some of the original and initial prescriptions that were going out were, as you can probably appreciate, for just a one-month or one prescription script. What we have been able to do is work with... And they're now writing them in three or six months, typically, because knowing that as a new product, sometimes payers won't accept a 12-month. But what we are seeing is that those scripts are being written in a manner that allows for women to get their refills done. We're starting to see refills, of course, starting to pop into the system now. But as I would remind everyone, because this is an on-demand or a PRN, only use it when you need it, That will vary depending on the frequency of sexual activity that each individual person has. So as you can probably appreciate, there will be some who fill their script every few weeks, and then there will be others who fill it every couple of months. So we have started seeing those pop in. We'll hopefully have better data points when we get to our Q4 call in March that will help us understand the frequency and how frequent people are filling those scripts again.
spk05: And Jeff, just to add to that too, we've actually had some interesting intakes with some of our Salesforce that there's a lot more patient-centered counseling that seems to be happening very actively now, either over the phone via telemedicine or in person. And so, for example, there are some patients On average, market research tells us that women have sex twice a week. So that's why when we designed a prescription, which is a box of 12 pre-filled applicators, we did that so women would have more, you know, should they need it. But also, if a doctor says that a monthly prescription, because a woman is more active, is a box of 24, that also could be a one-month supply. So we see that, you know, depending on what's happening with the counseling situation, that a typical, you know, a typical prescription is for a box of 12, but it could be as much as 24 could be a monthly supply.
spk01: Thank you.
spk04: Thank you. Our next question comes from Annabelle Samimi with TESOL. Please go ahead.
spk02: Hi. Thanks for taking my question. Just wanted to... go back to comments around prescriptions and refills. First, you mentioned I think it was 385 prescriptions have been written. Can you tell us whether the fill rate is very high or is there a lower fill rate? Secondly, on the refill, I know you've assumed about seven refills per year. Do you have enough data at this point to know whether some women are kind of gaming it around their cycle and whether that's the seven is the right number to use. You talked about higher, but is there anyone using it in a lower fashion? Then separately, just want to get your thoughts around net price in the first quarters. I know that, you know, the first prescription is at zero copay, and then after that it's $30. So how should we assume net price to evolve over the next couple quarters or next few quarters? And then finally... any additional market research you've done around keeping Sexy and Evo 100 as separate products. Thanks.
spk06: I'll jump in first before I flip it over to Jay. And so I think the real question, maybe Annabelle, if I'm hearing this right, is what was our abandonment around the scripts when they were first being written. And what we found was there was initially a few – of the women who would be told by the pharmacy that they weren't covered under the copay card simply because of the fact that that script got to them before the copay card did. We've been able to rectify that and make sure that the pharmacies are putting that copay card in for them. So there was a pretty small number of abandonments that happened at that point. The copay card has worked really quite well, and we've actually seen about 50% of those scripts that have gone through that required having a copay on that. As I kind of indicated earlier, the level of refills is at this point because we only had three weeks of data in the quarter and then we've got some data that's happened since then but it isn't sufficient enough for us to make any kind of statements around what we expect or anticipate the level of filling would be but when we did come up with that seven refills we did look at that as sort of the, if you will, the average. So we did know that there would be those who would, in fact, probably have up to 12 refills on a yearly basis and those who might have four. And when we looked at it in aggregate, we determined that the right number was right around that seven. So we anticipate that as we start getting into You know, three months, a full quarter's worth of data will have a lot better indicator of what that refill rate, you know, typically looks like. And then Jay can kind of speak to what our situation is right now with really early data.
spk07: Yeah, and, you know, obviously – you know, a few weeks don't make a permanent trend, but obviously the copay program in itself is designed to basically reflect, you know, in lieu of a sample, a free sample program, so it's really meant to really try and mitigate any sort of issues that women might have and, you know, really help reduce the risk of any high out-of-pockets that might cause abandonment at the pharmacy as well. So to that effect, you know, through September, as Russ said, We are seeing in that 40% to 50% range of women on commercial insurance taking advantage of the co-pay card. And to stress, it's not everyone that does get that first one free. We are seeing that split amongst that small proportion. So about half of those that are participating in the co-pay program do get that first one free. So that's half of about the 40% to 50% range of those people participating in And we're seeing about an average of 215 through the month of September for those first three weeks of an average co-pay. Now, going forward, you know, we obviously don't anticipate the program to continue in perpetuity. But, you know, we do expect, obviously, that we'll still be in place for the DTC launch that's occurring in the first quarter of next year. And then we'll continue to assess it as, you know, we continue to monitor prescriptions as it goes forward from that point through 2021.
spk06: And before I pass it over to Kelly just to talk about EVO 100 real quick, on the market research side, Annabelle, one of the key indicators that you can always point to is awareness. Awareness tends to be the one metric that both on a consumer and an HCP side will dictate what the uptake looks like. So we are currently working on getting our very first awareness market research done So we can start seeing after just a couple of months where we're currently sitting when it comes to that metric. And those are key metrics and ones that we certainly look forward to sharing as soon as their opportunity presents itself to do so.
spk05: Annabelle, did that answer your question?
spk02: Yes. Just one more follow-up, if I could. I know that you have your own specialty pharmacy that's distributing product. Is IMS tracking going to be capturing that accurately, or is there a part of the market that's not going to be captured because of that?
spk06: Yeah, that's a great question. So, no, the mail order, of course, which is through NPR-RX, and, you know, we do have some significant levels going out through that part. They are not captured through, you know, Symphony or IQVIA. We will, when we get to our reporting of that at the quarter's end, we will have we will have corrected those data points that come out of IQVIA and Symphony to include that data, but that will be up at the end of the quarter.
spk02: And how much is going through NPR-RX right now?
spk06: I don't have the specific numbers that are going through, but we are seeing that right now we're in the neighborhood of about 50% of our overall business is telemedicine. Now, some of those go through NIPR, and some of those are actually going through the regular bricks and mortar. So I don't have that specific breakout rate at the time to give you the number that are going through there, but it looks to be somewhere in that neighborhood of about 30%. Okay, great.
spk02: Thank you.
spk04: Thank you. Our next question is from Ramsel Barahu with HC Wainwright. Please go ahead.
spk09: Hi, thanks so much for taking my question. I just had a couple of questions regarding the marketing and promotional activities in support of FEXI. Can you just kind of give us a description of what the nature of those consists of at this point in the launch and how you expect that overall marketing and promotional activity mix to change over the course of the next two to three quarters. And then also, if you can comment on this in the context of the actual expense line item, and if you anticipate that based on the marketing and promotional spend as of right now, that this has reached steady state or whether you expect significant further quarterly increases in the months ahead as we get further into the launch. Thanks.
spk06: Thanks, Rob. Yeah, so our primary marketing approaches right now when it comes to the consumer side is through social media, primarily through Instagram, Twitter, and Facebook. And of course, as I always kind of say to my contemporaries, when they ask where are the ads, they're not seeing them, I usually say that's a good thing because if you are seeing them, you're probably in the wrong place because we're not targeting people of my age or gender on that one. So what's happening is we're active in those spaces. We're seeing a lot of activity. We're seeing a lot of repost of different things that are going out. And that's really taking place in that regard. What will change, if you will, is that we will come out with our commercial or our over-the-air video, as is referred to when you're using it online. And that will come out at the end of January. That will, of course, give us a higher level of visibility. And just as a reminder, The reason that you wait on that is because FDA does want to make sure that the healthcare provider audience is fully aware of the brand before you start sending women into them to discuss something that they're not completely familiar with. So we know that based on our activity right now with HCPs, we'll be in a position to meet those requirements by the first part of the year. So that's what will significantly change. I'll just mention broadly and then let Jay speak more specifically that a lot of the budget items that we've already put into the budget account for those changes that are taking place in order to be able to have that ready when we get to the first quarter of next year.
spk07: Yeah, and just to further, obviously, you know, not to beat this too much on the ground, we do anticipate that we'll be giving some additional guidance and insight into sales and marketing spend at our year-end call in March. You know, keep in mind we are reiterating our guidance that we gave, you know, FDA approval and launch there. about sales and marketing spend. Obviously, that's for a partial year, so I think it's only safe to say that it will go up in the next year, and we're currently working with Rust to see what that exactly translates to in dollars. I will tell you, though, I have told them you cannot have a Super Bowl ad yet, maybe in the future.
spk09: Yep, fully understood. Now, the last quick question was... If we look now at which segment of the target population appears to be most receptive to the promotional activities, at this juncture, do you have a sense of whether that is indeed those women who are not currently on any form of birth control or if it is a different segment of the population, i.e., for example, those who are on hormonal birth control versus those who utilize some other form of contraception? Thanks.
spk06: Yeah, so when we do our market research around awareness, we'll be able to get more granular. So you've asked the question, do I have a feel for it? And we are getting a feel for it based on a lot of what we see in social media, and it certainly is that segment that we've talked about with the 21 million women who are not currently using you know, a prescription form of contraception. They seem to be the ones that are having the most conversations around that. Many of those women are indicating that, you know, previously they've tried other forms of non-hormonal contraception that has been not satisfying for them. And so if I had to, you know, just say right now before we get all that awareness data back to us, it certainly is matching up exactly with what we anticipated it would be in terms of those women who indicated in our prelaunch market research would be most interested in this. It seems to be panning out pretty close to exactly what that research had told us in our prelaunch market research.
spk09: Okay, great. Thank you.
spk04: Thank you. Our next question is from David Amseland with Piper Sandler. Please go ahead. David, your line is open.
spk08: Okay, can you hear me now?
spk05: Yes, we can hear you now. Hi, David.
spk08: All right, thanks. So a couple of quick ones. First on sampling and co-pay assistance. Given that FEXI behaves in a lot of ways like a consumer product, and I don't mean that in a bad way, should we think of sampling and copay assistance as being something of a permanent fixture of promotion in the life of the product? So that's number one. And then number two, just moving on to STI prevention, I know that you've said that you're going to brand this differently, but I guess with that in mind, how should we think about the extent to which You'd need to expand the commercial organization to support that opportunity. Does it become more of a GP-focused effort? And help us think longer term, you know, the ramp-up in the commercial infrastructure and associated spend would be with that, assuming that opportunity bears fruit. Thanks.
spk06: Actually, I will acknowledge with you that, David, the category is a very much consumer-driven category, always has been, where women typically who have made a request of their healthcare provider for a certain type of contraception are more than 90% likely to get that. So we've recognized that from sort of the get-go and have made sure we structured all of our activities around that. So yes, we are seeing that women are, in fact, becoming aware of, going in, asking for, and talking about the opportunity for a non-hormonal brand opportunity. So we will continue to make our focus around driving this through largely women asking for and becoming aware of the brand so that it pushes through. It's as we usually say, it's that push-pull part where we're really trying to get the woman to push it into the doctor's office and then the doctor to pull through by providing a prescription for her or, in this case, going online. So as I've kind of said before, this is a category that women are not as inclined, as an example, having been associated with IUDs for many years, it's not as likely that someone would want someone else besides their own healthcare provider to do an insertion of something like an IUD, whereas in this particular case, We're finding women are pretty willing and accepting of going to a telemedicine opportunity to a healthcare provider that they may or may not know or that they even don't even have to talk to because it can be done asynchronously. So we're seeing women be the catalyst to drive the uptake. And he asked about the commercial sales versus STF. And so in regards to the SCI part of that, what we've also been able to look at, you know, again, we're still a little ways away from whether we'd have to increase the commercial footprint on that. Of course, as we navigate as the rest of the world does through the COVID-19 situation, we'll know more about those kinds of things. But we don't at this point anticipate that we will require a significant change in our footprint simply with the approval of those assets. And as we've mentioned on other calls, you know, we don't yet know exactly when it is done, and we do file how it will be filed, whether it's filed as an NDA that will be with FEXI or if it will be an NDA for a separate brand. And, of course, that will make some determination, but those Those considerations are still down the road, just a little piece, and we're not in a position to say today whether or not it fits one of those pathways or the other.
spk05: Well, and honestly, too, David, is that, look, with telemedicine and the telehealth platform, you know, we have recognized, obviously, we already knew the power of that, but the power is strengthening, right, every day as more women are getting used to, frankly, doing everything virtually. So, you know, if that maintains the momentum and continues to grow, that may mitigate the need of having, you know, so many feet on the street, so to speak. So, we continue to evaluate it, but so far we've seen, at least anyway with this current launch with FEC-C for contraception, that we do have actually a very, very, a perfect mix of the 70 people in the field with the telemedicine platform. But, yes, we'll keep evaluating it, but we may, in fact, not need to add it all.
spk08: Okay, and if I may speak in a follow-up, that's really helpful, but speaking of commercial infrastructure, and I apologize if I missed this, if you commented on this, but what's your level of urgency, if you will, or how are you prioritizing the potential addition of another asset in women's health where you can leverage the infrastructure you have in place?
spk05: Yeah, well, that's a great question. So in that Here's what I would say to you is that we obviously want to prove to everyone that we have the team in place with the right asset to knock this out of the park. And what we know is that once that's accomplished, it's going to put us in a very different position around cost of additional capital and opportunities for additional partnerships. So at the moment, I would say that there's not an urgent need. We do know a sales force is costly, and we recognize that. So we want to not get out of the park with sexy first, improve and show to everybody that we know exactly how it can be done, because then, frankly, we think we would be a more advantageous partner. There's a lot of companies we've talked to that are in phase two, but they don't have a commercial footprint. They don't have the expertise. And frankly, they don't know if they're going to be able to raise enough capital to build a commercial footprint, even if they wanted to. And so we think we will end up being the perfect, appropriate partner for them to talk to about putting their asset in our bag. But we do know that we need to stay very, very diligent and deliberate and focused on this product first, you know, to show the whole world that frankly, let's say they have an innovation that's never been done before, just like sexy, which we know there are some skeptics out there about that. We'll be able to show any partner, whether it's a product in a category that already exists or a brand new product that we know exactly how to do it. So, so I wasn't trying to be obtuse. The point is, is that it's not urgent because we have some time to show. And so we're talking to people and thinking about this, but I don't think that you'll see us take any quick action, um, and really advance it until the end of next year when we've fully proven the FECSI platform.
spk08: All right.
spk04: Thanks. Thank you. And this concludes our Q&A session for today. I would like to turn the call back to Sondra Pelletier for her final comments.
spk05: Great. Thanks so much. So I've had the opportunity to talk a lot about what we're doing and what we're doing in this virtual environment. And, you know, outside of breathing, talking about FFFXE is my most favorite thing, and I really mean that. And people have asked me, you know, what are investors, are they missing anything? And so the one thing I want to share is that we know that we have some amazing investors. And, yes, they are mostly male dominant. And these investors say to us, that they don't want their daughters to take hormonal birth control for 20 years. That they are worried about them suffering from side effects and not feeling like themselves. They say to us that they don't want the women in their lives to suffer from those kinds of side effects. And they really want the women that they know, that they talk to, that they care about to feel as good as they possibly can while protecting themselves. So we actually feel that everybody now understands that it is time for a new option. And once investors take the time to look under the hood, so to speak, of Avofem, they really like what they see. The one thing I know to be true is that there are moments in time that change categories. When, for example, The hormonal IUD came out, Mirena. It was a moment in time when women were tired of taking a pill every day. They wanted a fit and forget method. That product was supposed to do $74 million, and it does $1.4 billion today. That moment exists now for Phexy. Women want a non-hormonal option. They want something that they only use when they need it and never when they don't. They are ready to be empowered, just like men have been for years. And I know that I've said it before, but I want to say it again because the market is speaking to us and validating what we know to be true. That moment in time is happening again in this category, and it's happening for non-hormonal, and EvoFem is here to deliver. The company is filled with people who are the very best in their class. We've come together with a common mission to improve the lives of women by developing and commercializing real innovations. We have an approved asset in FECSI, and this is a surprising number to me, but only 14% of drugs that start the FDA process actually make it through FDA approval. So we're disrupting the market with a first-in-class hormone-free product. And we've just advanced our second asset in the pivotal Phase III study for prevention of chlamydia and gonorrhea, and again, there are no approved drug products to prevent these STIs. our trial will build on the very highly positive, statistically significant results that we already shared from our Phase 2B clinical trial. So we feel we've proven our ability to deliver on clinical rigor. We've proven our ability to raise capital when very few companies can bring in the money that they need, and we will prove that a Harvard Business School study should be written about how we successfully launched a product during a global pandemic. Ultimately, in the end, women deserve more. EvoFem is delivering. And if that is not worth investing in, I don't know what is. So thank you for your support and have a great rest of your day.
spk04: Ladies and gentlemen, thank you for participating in today's conference. You may now disconnect. you Thank you. Bye. you you
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