SCYNEXIS, Inc. (SCYX) Earnings Call Transcript & Summary

Good afternoon, and welcome to the SCYNEXIS Conference Call. [Operator Instructions] As a reminder, this call is being recorded and a replay will be made available on the SCYNEXIS' website following the conclusion of the event. I would now like to turn the call over to Irina Koffler of LifeSci Advisors. You may being.

Good afternoon, and thank you for joining us as we provide a corporate update on the pending BREXAFEMME launch for the treatment of VVC. Joining me today from SCYNEXIS are Dr. Marco Taglietti, President and Chief Executive Officer; Dr. Michael Krychman, Health Science, Clinical Professor at the University of California Irvine, Division of Gynecological Oncology; Christine Coyne, Chief Commercial Officer; and Eric Francois, Chief Financial Officer. During this call, please note, we will be making forward-looking statements. These statements are subject to factors, risks and uncertainties, including those that are detailed in today's presentation and our Form 10-K for the year ended December 31, 2020, as well as our subsequent SEC filings that may cause actual results to differ materially from those results expressed or advised by such statements. Please also note that this call is being webcast and accompanying slides are available on the investor page of the SCYNEXIS website at www.scynexis.com. With that, I will turn the call over to Marco for his opening remarks.

Thank you, Irina. [Foreign Language] Since our approval of BREXAFEMME for the treatment of VVC, there's been a lot of excitement in the medical and patient community. And we've been getting a lot of investors' questions about our commercial plan and the timing of our launch. Additionally, BREXAFEMME's approval has generated significant media and industry interest and coverage and key publications. We've been working diligently behind the scenes for quite some time to get ready for the launch of BREXAFEMME. And I'm really proud to share the details of our plans with you today. First, I wanted to disclose that we intend to launch rapidly in third quarter 2021. And even though we are selling into a largely generic fluconazole market, we will show you that there are significant dissatisfied segments that we think we can rapidly capture within a large and growing VVC market. After my introduction, you will hear from Dr. Michael Krychman, who will highlight the need for a second oral agent, especially one from a new class of antifungals. Then Christine Coyne, our Chief Commercial Officer, will then showcase BREXAFEMME's value proposition and our approach to making the drug broadly available to patients. And finally, Eric Francois, our Chief Financial Officer, will discuss our balance situation and provide some high-level financial update. We will then open up the call to your questions. BREXAFEMME is now approved for the treatment of VVC, which is a great statement, makes me smiling every time I say it. It's always an exciting moment to get the drug approved by FDA. And what could be more exciting than to get a completely new class to patients. BREXAFEMME represents the first new oral treatment for this condition in over 25 years, and it is a disruptive innovation in the space. We expect BREXAFEMME to be a great success. And let me give you 5 reasons why we are so confident. Reason number one. One of the first things you will hear from Dr. Krychman and our commercial team is that there is a substantial medical need for another oral agent for the treatment of VVC. VVC is a significant medical problem because it affects multiple aspects of patient's wellbeing. If you see is also extremely common and Dr. Krychman will show you that many women suffer frequently and often cyclically from this condition. If improperly treated, the condition can persist and create new challenges for patients. Our second reason for success is that BREXAFEMME represents a disruptive solution to VCC. It's hard to believe that there is only 1 oral product, fluconazole for VVC. And it was approved more than 25 years ago. It has been so far a one-size-fits-all approach. How can one size fit the needs of millions of vulvovaginal candidiasis patients with different and diverse characteristics. It was done for an alternative product for VCC with a different mechanism of action. BREXAFEMME is fungicidal, killing the fungi by breaking down the cell wall of fungal organisms and it is different from azoles, which are fungistatic. With BREXAFEMME, there is finally an alternative for how VVC can be treated going forward, and health care providers no longer have to rely solely on azole plus. Our further reason for success is that there is no active promotion in the VVC category, which make us the loudest and only voice promoting in the space. We are in the enviable position to be the market leader and we intend to maximize this opportunity and our first-mover advantage. What does that mean in more concrete terms. It means that our reps will have more time to be heard. Our promotional materials will be more visible and we will be able to negotiate payer coverage with minimum branded pressure. We are also the only company to be actively engaging with the patients community. Over the past 18 months, we had more than 1,600 interviews with health care providers and patients, and we know that both prescribers and patients are eager to try something new. And BREXAFEMME will become quickly recognized as a long awaited alternative to azoles. We sometimes hear that it made difficult for BREXAFEMME to penetrate a generic market like VVC. Honestly, we don't see it that way for a very simple reason. It has been shown over and over that when the first representative of a new class with a new mechanism of action enters any generic market, it usually does very well. ACE inhibitors versus generic beta blockers in heart patients, SSRI versus generic tricyclic antidepressants, Kenonel arms in community infections, DPP-4 inhibitors versus generic oral antidiabetic drugs and so on and so forth. When you have a real new alternative entering a generic market, the innovative product will generally do well, not necessarily by replacing the generics, but by meeting the needs of all those patients for whom the older generics are not any longer the right solution. We believe BREXAFEMME will be no exception, as you will hear from Dr. Christine. Reason #4 is critical and will be the focus of Christine's discussion. When I was in the army, our Colonel used to say that strategy #1 is operational excellence and operational excellence and the culture fostering teamwork and collaboration has been our hallmark at SCYNEXIS. SCYNEXIS has a strong track record in executing upon its clinical programs, culminating with our most recent regulatory success in achieving the first pass approval of a BREXAFEMME NDA. Over the past year, we have focused on bringing in the right commercial talent. We now have an experienced commercial team in-house and have partnered with a strong commercial organization, Amplity Health, which has a formidable launch track record in many therapeutic areas, including women's health. Christine will present to you our commercial vision and plans being implemented. And I believe that by the end of our event today, you will share our confidence in our commercial vision, competency and preparation. Reason #5 cannot be overstated. We have a cash runway into 2023. And have ample cash and access to cash to support the BREXAFEMME U.S. launch. We have also established 2 sources for additional nondilutive funding, one through our existing debt facility. And the second, by the potential continued monetization of our patent rights outside of the U.S. And even so, today, all eyes are on the BREXAFEMME launch, we know that VVC is just the beginning for our company. A BREXAFEMME represents an important innovation not only in community, but also in hospital settings, and we are steadily advancing our clinical pipeline to expand the BREXAFEMME label into other indications. We have at least 14 years of patent protection to build our brand into a long-lasting, profitable antifungal franchise in both the community and hospital settings. And now it gives me great pleasure to introduce you to our renowned speaker, Dr. Michael Krychman, who will share with you his views on the treatment option in VVC and the remaining unmet needs in the space. Thank you. Dr. Krychman?

Thank you, Marco. It's really a great pleasure to be here this morning. And before we jump right in and give you some background on VVC and a perspective of the important aspects of treating VVC, I just wanted to let everybody know that unfortunately, as things have started to open up in Southern California due to changes in the pandemic restriction, I have been called back into the hospital. So I will apologize in advance if for some reason, I'm not available for the question-and-answers. But I certainly will make myself available through the company for any kind of questions or concerns you may have. So I just wanted to begin with the next slide, please, and give you a little bit of a background in terms of who I am and why I have such an interesting and diverse perspective about VVC. I am a board-certified OB/GYN, I'm a help Professor the University of California, Irvine, and I have really a diversity of clinical care centers. I have a private practice in Newport Beach, and I run 2 high-risk breast ovarian centers at the University of California in Irvine as well as I'm at the University with the student residence. And I come from New York City, where I was the Co-Director of The Sexual Medicine and Rehab Program for cancer patients at Memorial Sloan-Kettering. So I see a diversity of patients. They have a diversity of ages, ethnicities and even insurance backgrounds. And I think the important concept to remember is that VVC is certainly a very big health concern across the board. It is a big deal. It's not a minor nuisance, and the bottom line no matter where you practice as a clinician, whether it's in the private insurance, the HMO or other areas of coverage, it really is frustrating. As a health care provider, it's frustrating to have of such an important condition only really being addressed by 1 class of drug. Next slide, please. So this is really an important slide as far as I'm concerned. It's the scope of the background in terms of VVC. And again, the important thing to remember is that very often, this condition is underserved, it's neglected. It may be forgotten. But it really has a huge impact on women. And you can see here, 75% of all women experienced at least 1 episode. Almost 50% have 2 to 5 episodes, and we'll talk a little bit about that. There's a huge amount of visits to the clinical provider. And what we are seeing is a trend of emergent alternative species. So this condition is caused by a variety of species, not only Candida albicans, but glabrata. And again, we are kind of wearing handcuffs because we really only have 1 class of medication to treat this. And this is the azoles. And again, we'll go through some of those issues in terms of the treatment paradigms. But again, North American women certainly prefer oral therapy, even though topicals are available, they're really not very much prescribed. And it's interesting, I often talk with the SCYNEXIS people, and they asked me, when was the last time you prescribed a cream for the treatment of VVC and it was never. The active vibrant women of North America prefers pills, they prefer this treatment, which is very, very easy do. Next slide, please. So just by way of background, these are the most common physical signs and symptoms. You can see things like swelling, redness, fishers, abrasions, abnormal discharge, burning irritation. But very often, what we will see is this impact on intimate behavior with the patient and their partner, it is very much influential in terms of relationships. And although the signs and symptoms are nonspecific, other causes can certainly lead to this, and it leads to really suboptimal care. And you'll hear me over and over say that once a person has been given fluconazole and they fail and they have persistent symptoms that are really bothersome. And you can see here burning irritation, itchiness. These are not just minor nuisances. These are very impactful on a physical level for a woman. And where our hands are tied. Once they fail Diflucan or Difluconazole, what do we do? Well, it's more of the same is fluconazole. And if they fail that, what is our choice then? It's just the same, more and more of the same and suboptimal treatment with patients who are really suffering on a daily basis. Next slide, please. And for me, this is something that's quite important because not only am I an OB/GYN and practice medicine, but I'm also a counselor. So I deal with these issues of the medical facets that we have with medical conditions that impact women psychologically, they impact their intimate relationships and they also impact productivity. So there's far-reaching tentacles from a medical condition such as this. I think really, it's too often, people have minimized this, and it's really a very, very big impact condition. Women will have decreased self-confidence. They'll have increased stress. I would even see people present with really depression because they feel that there's nothing out there that can help them and that they're going to be suffering for years and years on end. We certainly see impact of the relationship. I've had men actually tell me that I need to find a better treatment for their partners because this infection is really impacting their intimate relationship as well. So again, I think it's really important to kind of bring this to the forefront and really understand how impactful this condition is. We do see a loss of productivity for those same reasons. Imagine if your pelvic area is burning and itching and you can't sit, it really has a far-reaching implication. And I know sometimes numbers are really important. But again, look on the right-hand side here in terms of loss of productivity, and there's really a significant economic burden. We can see a loss of productivity in the billions in high-income countries, $4.7 billion in the United States and even loss of time from work. So I think there is both a physical impact in terms of medical issues, there's a psychological impact as well as an economic burden that we are sharing because of our limitations in terms of treatment options. Next slide, please. So I think this is the best take-home message here. And as a clinician, I always like to think what are my tools in my war chest to help women feel better. And as I said earlier, we have 1 weapon, and that weapon is not very effective in terms of treating VVC. Even other common conditions that we have like UTIs or diabetes or hypertension, we have a multitude of therapeutic options. But we are really using handcuffs in terms of understanding what we can do. And as I said before, what if somebody fails the initial treatment? Well, we give them the same treatment again and again and again, really with very much limited opportunities until now until BREXAFEMME with a new mechanism of action as well. Next slide, please. So here is the standard paradigm. And I think the important issue to remember is that the vast majority of patients who come in to see a clinician, nurse practitioner or an MD or DO, are these severe and complicated cases. These are women that have persistent issues. They are suffering in silence. They have persistent burning, itching pain, and it's really impactful. And we very often, I run a high-risk clinic, so I see here women with have chronic conditions. Women are living longer. We have women who are having multiple medical issues, including diabetes that's on the rise, and everybody in my center says it's not called COVID-19 for the year it was, it was for the pounds of people are gaining and there's this trend towards obesity. We are seeing these issues of recurrent VVC much more prevalently. And the non-Candida albicans species as well. If you look on the other side, you'll see that there's a lot of creams. And again, I always say women are not very pleased with these creams. They have severe drawbacks. They may exacerbate, even exacerbate the conditions that they're having because of a variety of different products that these creams are made with. So the trend now has been for fluconazole. And what I will tell you is that if you speak -- I spoke with a lot of my colleagues and now the standard dose is multiple doses because we recognize that even if it's indicated for 1 single dose, we know it's not going to work. So we want to avoid the nuisance factor that people are going to be calling, coming in, complaining, bottlenecking our offices. So very often, we'll prescribe multiple doses as the initial treatment. So I think that's an important concept is that we have no options. We are frustrated as clinicians we know that one size doesn't fit all depending on the woman, her characteristics, her experience of VVC is very, very different. And to have only 1 opportunity to have an effect is really troublesome as a clinician who wants to help women in individualized care. That's where we're moving. It's individualized, personalized care to really treat women effectively based on their experience. Next slide, please. there are certainly limitations as we talked about. We said it was introduced in '94. It's a single dose. And I can't remember when I just gave somebody 1 dose. I'm often writing multiple doses, multiple treatments. So they can be -- so we can try to treat them effectively. I think the important concept that resonates with clinicians is that this is a new mechanism of action that it's different. It is not fungistatic. BREXAFEMME is fungicidal and it really, really is impactful and does affect the Candida species. It's not just making the species quiescent or quiet. It's really killing the species and has a new mechanism of action. North American women prefer oral therapy. I always joke with the patients and they say, if you're a woman on earth with gravity, you put something in the vagina, it's going to leak and it could be problematic. It may cause increased burning, increased irritation, which leads to discontinuation. And because of the multiple treatments and because of the multiple treatments of the same medication, we are seeing a growing trend towards resistance. And again, I have high-risk patients who come to see me really from all over the country. I have a very huge following. People have come to see me because of this concern of this growing resistance as well. Next slide. And again, 1 dose is not effective. And I think the staggering statistic here is 70% of patients need more than 1 dose. Almost 50% don't have a therapeutic cure. And now the trend is we just give multiple doses. And I know it sounds frustrating, but it is patients who failed fluconazole had only one other alternative, only more fluconazole. And when they fail that, they fail again, and then they get more, and more and more. And we're really kind of chasing our tail in terms of trying to get these patients better. So again, they lose confidence in their clinicians because we're not giving them an alternative. And that really is very upsetting on a clinician patient therapeutic alliance concept. So we need more things in our war chest. And it's very exciting to have a new medication for a condition that really has sometimes been forgotten, it's underserved, it's neglected, but clinicians see it every day. I always tell the clinicians in the residency, in their training. This is your bread and butter. And I'm at the helping the residents now for coverage. And I actually told them about this medication, and you had to see how excited they were because they were like, it's not the same old, same old. It's something new. It's something exciting. They feel really vibrant that they can really help their patients get better because we see it on a day-to-day basis how women are suffering and I really, say, suffering in silence. They come to get used to these symptoms when they really shouldn't be. Next slide, please. These are real women that I've seen in my clinical experience over the years that have had VVC. And Again, these resonate with everybody. We have a mother who has resistance. She is experiencing painful intercourse and it's impacting her relationship. We have women who've developed of public pain syndromes for treatment failures. We see the obese diabetic women who has poorly controlled underlying conditions. It's not uncommon for anybody to know a woman who has breast cancer. They have challenges maintaining their vaginal pH, and they're very much prone to yeast infections. And they've been really over medicalized. They have had lots of medications, chemotherapy and it's very challenging to treat a Candida infection in a breast cancer patient with multiple, multiple, multiple doses of the same. So very, very challenging. There are 6,000 women entering the menopause every day. So 6,000 women are stopping their periods. They're having challenges in terms of vaginal pH. They have issues with getting yeast infections. And these women, 50 -- 51.3 is really the new, I would say, the new 30 or 40. These women are active. They're vibrant. They're running companies. They are mothers. They are executives. And they don't want symptoms of a yeast infection to get in their way to impact their quality of life. And again, even as we see women age, well into their 60s or 70s. They have chronic conditions, rheumatoid arthritis. There is not uncommon to see immunosuppressive issues. And these women certainly as well have lots of problems in terms of getting a yeast infection. So this is my way of telling you how VVC can affect a woman over her life span. So it's not just a condition for younger women or older women. It's really a troublesome condition that affects women as she ages, as she progresses through her lifestyle, as she changes in terms of her growth and her medical history as well. Next slide. So for me, I recognize as being a consultant for the company, I recognize the indication. It's here indicated for the treatment of postmenarchal females with VVC. It's contraindicated in pregnancy, most frequent adverse events is GI in nature. And again, I don't see the contraindication as any area of concern for me as a prescriber. I think for me, the exciting opportunities here is it's the first ever alternative. And I think that's really very important. We had no other choice. And now we have a choice that has really broad spectrum, can affect a variety of species and really understanding that 50% of our patients are going to fail the initial treatment. It has sustained outcomes. So it will help with duration effect. It's effective both in the uncomplicated and in the complicated VVC patients as well. I think the mechanism of action is really exciting. I think fungicide is resonating with clinicians and residents, and medical students as well that it kills the Candida species. So it really is very impactful. It's very impactful against multiple species as well, and we're seeing that -- those trends. And again, I think we need to keep in mind the concept of personalized medicine. We need to know who our patients are, patients are active women who want oral therapy. This is patient-friendly. There's less frustration for them, less anxiety. And I would say -- I would also say there's less frustration and anxiety for a clinician. So when a clinician is satisfied with the drug treatment, they're more likely to use it over and over again. when they have other alternatives. So again, for me, this is groundbreaking. This is a deal changer for a very common, very problematic condition that was often neglected by patients and by clinicians because we didn't have good choice. So I think choice is really a great opportunity. So with that, I'm going to conclude, and I'll hand the slides over to Christine. And again, I want to thank you all for the opportunity to speak with you. And I hope that I will be able to answer any questions or concerns you may have. But again, I do apologize in advance if clinical care takes me away from the call. Thank you so much.

Thank you, Dr. Krychman. Such wonderful perspective. Thank you for the reminder. Good afternoon, everyone. I am so excited to be here to stand before you on behalf of our hard working commercial team and share our carefully constructed action plan for launching BREXAFEMME. I will show you the significant market opportunities for this product, the high degree of physician and patient frustration with a limited number of treatment options and lay out our concrete action plans that we have taken as a company to build customer support, gain payer coverage and facilitate patient access. Later, Eric will walk you through some of our financial assumptions which will add more context to our discussion. As you can see from the data in this slide, in the last year, there were 16 million fluconazole prescriptions written for VVC with another 1 million or so topical azole prescriptions. This is just to say that VVC is an extremely common condition, and there is much discontent among women regarding the treatment of their yeast infections. There is also a large over-the-counter market for VVC, it's not represented on this slide. For now, we are focusing our attention on the prescription market, and we will build adoption there first. A largely untold truth that may not well be appreciated is that many women suffer from repeat yeast infections. You just heard from Dr. Krychman about this. Exposing them to multiple courses of fluconazole over their lifetime. As you can see from the data, 80% of VVC sufferers will have more than 1 yeast infection and over 1/3 of women may have 6 yeast infections or more in a lifetime. Fluconazole and other ASL treatments may not be working well for these patients or may lose its potency over time, demonstrating a need for a new antifungal agent. One thing we learned in our market research is that few HCPs are happy with the existing range of treatment options for yeast infections. As Dr. Krychman described, doctors are frustrated with the limited number of options they have to treat a wide and diverse patient population. Furthermore, they really have little to offer a complex or a challenging patient, which frustrates them. As per patients, they are equally frustrated. They're anxious and a shame of a fairly common infection and many resign themselves to a lower quality of life due to a lack of treatment options. Doctors feelings of not being able to help their patients adequately enough combined with patient feelings of anxiety, shame and frankly, surrender in some ways, lead to compounded frustration. Over time, these patients with multiple comorbidities and concomitant medications have become increasingly common. Add all of this to a treatment landscape where there is only 1 oral treatment option and you have a clear need for an alternative. In speaking with more than 1,000 HCPs during our market research, we heard just how excited they were about BREXAFEMME. They were extremely encouraged by the product attributes of BREXAFEMME and eager to prescribe it for many of their patients. Just about every HCP conveyed that they already had multiple patients in mind for this new alternative. What was truly remarkable was that they instantly got it. They said things like, "Oh, this is not an azole." So there may be fewer drug-drug interactions to worry about. Or we would hear them say, it actually kills Candida, and it is an oral 1-day treatment. Also when asked most doctors reported to us that they were willing to offer BREXAFEMME to their patients who would ask for it. Health care providers with whom we spoke quickly and clearly identify patients who would most readily benefit from BREXAFEMME, including patients with persistent or multiple vaginal yeast infections, patients with severe symptoms, patients who couldn't use fluconazole and patients with multiple comorbid conditions. Doctors also indicated that they want to use BREXAFEMME first line, in some patients who they knew would not do well on fluconazole. In totality, there is a broad range of patients for whom HCP see immediate use of BREXAFEMME. Given these patients' medical needs and limited treatment options, HCPs reported that they would be willing to work through initial administrative barriers for BREXAFEMME, while insurance companies complete their review process. BREXAFEMME's non-nasal fungicidal activity, convenient oral 1-day dosing make it appealing for a broad range of patients. As Dr. Krychman delineated earlier, they could look like the busy executive, who is constantly traveling. The inpatient college student, the at-home mother, who can barely find time for the doctor's visit. Much like other new drug introductions, we expect health care practitioners will expand their use of BREXAFEMME once they gain their own practical experience. BREXAFEMME is broadly indicated for adult and postmenarchal pediatric females with VVC. It is contraindicated in pregnancy. The attributes of BREXAFEMME make it a much needed modern day treatment for women suffering from vaginal yeast infections. These attributes are its ability to kill Candida, completely eliminate the signs and symptoms of VVC in a majority of women. It's broad-spectrum in-vitro activity, 1-day dosing and its ability to do its job and then exit the patient's body quickly due to its 20-hour half-life. With an understanding of this large market opportunity and the increased confidence in the HCPs' positive reception to BREXAFEMME, let's now have a look at how we are going to commercially address this opportunity. Like all product launches, there are multiple pieces of the plan that must be considered. First is the BREXAFEMME label, a very strong label, clearly communicates the clinical data regarding all of the important product attributes we have been discussing. The second is our promotion, which breaks down to our sales representatives as well as unbranded and branded campaigns. The third is our work with payer customers. And the fourth is facilitating patient access to BREXAFEMME using tools such as retail stocking, prior authorization education and co-pay buy down as well as providing patients with the flexibility to utilize telemedicine if they choose. All of these pieces together is important for our success. In the next few minutes, I'd like to provide more specifics on 3 key areas: our selling strategy and abilities, our engagement with payers that will lead to access and ensuring patients receive BREXAFEMME in a timely manner. Our team has been diligently working on these initiatives for quite some time, and we are well positioned for a successful launch. On the HCP promotion front, we have identified 60 sales territories, which allow us to efficiently focus on the geographic areas with the highest concentration of VVC prescription treatment. We, along with our partner, Amplity Health, have assembled a strong sales team. All of whom have significant launch and women's health experience and both been recognized multiple times for top performances. Our field team is fully hired and in the process of onboarding and training. Along with our field-based team, we will be launching with an inside sales team to further extend our reach and provide increased visibility of the external environment. This structure will allow us to learn and adapt quickly to market conditions. We will augment the efforts of our sales representatives with branded digital journal and search advertising along with promotional webinars. We will also have a presence at relevant medical conferences such as the nurse practitioners in women's health this October. I called this conference out in particular because nurse practitioners play a big role in VVC diagnosis and therapy. You'll note that we generally refer to HCPs, health care providers or practitioner rather than just doctors, and this is by design. We will be focusing our efforts on the high prescribers which for VVC includes not only OB/GYNs, but also nurse practitioners and physician assistance. The latter groups that are often times overlooked by sales teams. We were encouraged by the HCP response to our recent unbranded digital campaign called Rethink VVC. It ran from for 8 weeks from April to June, and its call to action was to learn about a novel non-azole VVC treatment. More than 12,000 HCPs visited the site. This was the tremendous result. This early indicator continues to confirm the breadth of HCP interest in BREXAFEMME. Not only is the VVC prescription market large, but it also has a significant volume of commercial coverage. 63% of patients have commercial insurance. And as I mentioned earlier, our initial payer outreach and preapproval information exchange began in early April of this year. Post approval, the national account team, along with the medical team began the next phase of payer engagement, which are clinical reviews and value proposition discussions. The team has made great progress by completing clinical presentations to payers whose members account for 70% of covered commercial lives. This great work has resulted in the scheduling of 14 payer reviews at the last count and still going. One of the most often asked questions for a prelaunch product is how much does it cost? Or what is the price? For BREXAFEMME, the price to wholesalers known as WAC, wholesale acquisition cost, will be $475 for 1 treatment course or 4 tablets. Extensive research across all stakeholders of more than 1,600 participants confirm the value of BREXAFEMME and this $475 WAC. The unmet patient need and the innovation that BREXAFEMME brings were confirmed across payers, physicians and patients. Given the $475 WAC, the expected impact to payers budgets is low, which gives us the ability to work with payers to gain coverage of BREXAFEMME quickly and to increase coverage and patient access over time. And now for the last critical piece, ensuring patients receive BREXAFEMME in a timely fashion. As a small company with a 1-day treatment for an acute episodic condition, we are very aware of how critical it is to enable a good experience for patients and prescribers, from the point of prescription all the way through to fulfillment. HCPs need to be able to prescribe with as little hassle as possible. The product needs to be in stock at the pharmacy and the patient needs to be able to obtain BREXAFEMME quickly and affordably. To accomplish this multipronged goal, we are executing a strategic stocking plan with the major retail chains and putting in place an ecosystem at launch that includes prior authorization services, a widely available co-pay part program and a telehealth option on our website for women who prefer engaging with HCPs virtually. The launch plan is comprehensive and robust. Execution of the plan is underway and early indicators are strong. BREXAFEMME product is expected to be received by wholesalers in July and on pharmacy shelves in early August. Our field teams are being trained and are on track to begin engaging customers in August. The prescription support ecosystem will also be functional in August. In September, we will begin a series of key opinion leader led promotional webinars, and we will roll out our full branded HCP advertising campaign. In summary, the time for BREXAFEMME is now. The opportunity is great. There is a large and growing market and frustration on both the HCPs and patients parts, as they both seek new and different options. BREXAFEMME, with its non-azole fungicidal attributes, it's oral, 1-day dosing is just that treatment option. And SCYNEXIS with a thoughtful launch plan and passionate team is just the company to bring BREXAFEMME to those HCPs and patients in need. And now it is my pleasure to inter introduce Eric Francois, our CFO. Over to you, Eric.

Great. Thank you, Christine, and thank you, everyone. I'm extremely proud of our strong financial position to execute on our current plans, which include both commercialization of the VVC indication and advancement of our hospital programs. First, we have a long cash runway into 2023, with a cash balance of over $92 million as of March 31, 2021. In addition, we recently announced that the company took down a total of $30 million from Hercules and SVB term loan this quarter, $20 million at closing and $10 million post VVC approval, with access to an additional $30 million later on. This brings our nondilutive financing to over $45 million this year after our $85 million transformative equity deal in December of last year. In addition, as announced a few months ago, we have already entered into a value-creating partnership with Hansoh Pharma for Greater China, where we are eligible to receive an additional $112 million in development and commercial milestones as well as double-digit royalties. And as part of our overall strategy, we continue to focus our effort on monetizing our ex-U.S. WAC to BREXAFEMME to generate even more nondilutive income. So while we are not yet giving revenue guidance until 2022, I wanted to reiterate our U.S. revenue expectations in VVC alone. As Christine pointed out, there were over 17 million prescriptions for VVC last year. And assuming our approved WAC of $475 that equates to an approximately $8 billion total addressable market. And we believe ibrexafungerp, a new class of antifungals for VVC, represents a revenue opportunity of $400 million to $600 million for SCYNEXIS in the U.S. And we also believe that there are multiple upside scenarios for ibrexafungerp in this market, which will be further assessed as we continue to gather information post launch. And on to the $475 WAC assumption, we are also layering in typical pharmaceutical gross to net discounts, which are expected to be higher during the initial launch period to help facilitate patient access. Now as you build your models, we also wanted to provide additional visibility into how we're thinking about our expense line. Historically, SCYNEXIS spent a majority of its roughly $50 million operating expense on R&D, as we invested behind the large Phase III program in VVC. As we launch BREXAFEMME in VVC, we expect our operating expense to increase in the second half of 2021 due to increased investment in selling and promotion, and will stabilize to this new level in 2022 and beyond. Our future R&D spend is more variable and will be dependent on our continued investment in hospital franchise to opportunistically pursue high-value indication, which is under our control. We will provide more guidance next year. What is important to realize is that we have significant access to different sources of capital. And importantly are on our way to profitability. Thank you for your time, and I would like to turn the call over to the operator for Q&A. Thank you.

[Operator Instructions] Our first question comes from Louise Chen from Cantor Fitzgerald.

So I had a few questions here. I know you went through a lot today, but could you summarize how you're going to reach your target patient and exactly to what is your target patient for this product? And then you had mentioned the half-life as a benefit for BREXAFEMME. And how do you think of that in terms of the RVVC opportunity, the half-life and how fits to that treatment paradigm there? And then you also had noted there's a percentage of patients that can't use fluconazole or where fluconazole may not be effective. So could you sort of characterize that patient population where BREXAFEMME would immediately be the first-line choice?

Well, Louise, as usual, you have a lot of good questions. So let me start actually taking myself about a half-life first. And after I will ask Christine to comment about how we will reach to target patients. And then if Dr. Krychman is available to talk about what are the patients were fluconazole cannot be used. So half-life we believe of 20-hour half-life. Sorry, I can see some echo I can here.

You got to mute yourself.

Okay. Very good. So I will start with the half-life. We believe the half-life of 20 hours really the right length of a half-life, which provides good penetration in the tissue, allow us also in the hospital indication to achieve rapidly a steady state. And the most important once the product done its action actually is rapidly eliminated. It doesn't linger around in the body of the patient. So we do believe that -- it's a good half-life that allows also to give a treatment, which is a 1-day treatment. Let me now move to your second question. How can we reach to the target patients and Christine maybe you can very quickly give us a summary how is this going to happen.

Yes. Thank you, Marco. Thank you, Louise, for the question. You saw the U.S. map where we showed the geographies where the highest concentration of VVC treatment is. And in those same geographies, obviously, are the prescribers. So we are exquisitely focused on those high potency targets. And how we would address the patients, the trick here is making sure we're clear in communicating the attributes of BREXAFEMME for the needs of those patients. And so we will do what is called a patient library. The field teams will -- they will carry patient profiles with them to help to describe to the doctors the appropriate patient types for BREXAFEMME very clearly. I hope that helps.

Thank you. Thank you, Christine. And Dr. Krychman, if you can tell us your view about what are the type of patients where fluconazole will not be appropriate or cannot be used?

Well, I have a very diverse patient population. And I think -- for me, I think the take-home message is, it's not fluconazole and it's a newer treat. It's a new treatment that is safe and effective, well tolerated. I'm an early adapter, and very often OB/GYNs are early adapters. And especially in the case where we've had no other choice, no other option. I think people are going to be very interested in seeing the clinical research in action, seeing the research in action, seeing patients being treated as frontline and not coming back again and again and again, or needing multiple, multiple doses. So in that respect, I think it certainly has the opportunity to be a front line for every woman who comes in. I think that's a huge opportunity. Please understand that I also have a very diverse patient population that has risk factors for recurrence. So it's not uncommon that 3 or 4 times a day every day that I see patients, they've had multiple infections. There's either resistance or they are not getting effective treatment or there is a recurrence, and this would be my initial go to as well as the tough cases like we talked about the cancer survivor, we talked about the diabetic, we talked about women who have immunosuppression. So I think you have to understand that there's 2 facets here. One is the everyday OB/GYN, who will use this as a frontline option as well as for their patients who have multiple treatments throughout the course of the year, as well as those who are at higher risk for recurrence or different species. The disease has evolved. And what that means is that Candida, because of telehealth, we've been treating over the phone, not seeing patients. We've actually, as clinicians have created more resistance. We've created more problems than treated them. So this comes at a great opportunity to save and effectively treat a huge diverse group of patient population.

Thank you. Thank you, Dr. Krychman. And thank you, Louise, for your questions.

Our next question comes from Dana Flanders from Guggenheim.

Great. Thank you very much for the questions and very helpful update today. Maybe just my first quick question for Eric. Can you just comment on what your rev recognition practices will be certainly early on in the launch?

Dana, yes, thank you for the question. So we'll follow the ASC 606 and will revenue -- our revenue recognition will be followed per the new guidance. And so that will start kicking in. Conversations with the auditors actually right now in preparation for the second half of the year. And I can certainly happy to provide additional clarity on what will be included from an accounting perspective, but pretty straightforward.

Okay. Okay. Got it. And I know on the pricing side, $475, I think that comes in towards the higher end of the range you guys were considering. Can you comment on just some of the factors as you did your analysis and got the label that led to that? And maybe you can also just help us understand, I think you said kind of gross to net would be typical pharma discount. What do you guys consider kind of a typical discount for gross to net?

Thank you, Dana. And let me just say that setting up the WAC price, as you know, is a complex and lengthy process that involves many, many different parties. So sometimes, we have been based on our initial conversations, we have been always saying that we were expecting the price to be between $350 to $450. However, Christine can actually go now through some of the key points on why after actually further discussion that something happening, especially after you have a natural product approved and a natural labeling, why we came to this decision to a WAC price of $475. And then Eric can comment on that. So Christine maybe you can spend a few words on how we arrived with the price of $475.

Yes. Thank you so much. We did the usual and customary pricing sensitivity with payers. We also did the value recognition with HCPs as well as patients. And so once you understand these are clinical attributes of the product to the stakeholders, and you understand what kind of value it in their eyes it is, you put those inputs into pricing sensitivity, and that's how you get to the ranges that Marco had talked about. And then we, of course, always check it over time because a lot of work has been done in the last year. We do last check on it and everything seems to hold up. And so that's where we are at this time.

And on the gross to net, I think certainly, we're not going to guide on gross to net going forward. I think this is a very important and sensitive information, as you can expect. It's going to be very consistent and comparable to other small companies in similar therapeutic categories. By the way, we also anticipate, as you can also have you seen in other situations that our margins will improve over time as coverage and retail demand improve. So -- but I'll let you assess the general benchmark for gross to net assumption in your model and happy to follow up with you. But we're not going to provide specific numbers.

Okay, okay. Got it. And just maybe my last one. I know in the past, you've provided a very useful diagram showing kind of increased BREXAFEMME share as just the incident of VVC kind of increases among women. As you've done your market research, are there any other just patient characteristics or kind of aspects of the treatment paradigm that you've identified that you think will be very large drivers of increased share of BREXAFEMME. Maybe you could just help us think about that aspect of the launch as well?

Thank you, Dana. And just let me say that we have been saying that we saw 2 groups of patients that actually were present and can be really of help. Patients, as Dr. Krychman was saying and I may quote Dr. Krychman in a second, patients that have been failing multiple times. And to a certain point, they are just tired and going to a doctor and just say, please, can you give me something else than fluconazole. But also there are a group of patients that has actually co-morbidities with obese patients, the weight of patients poorly controlled, patients that may receive some kind of immunosuppressive therapies, steroids for a variety of conditions. So there is all these diverse population. And Dr. Krychman, if you are still available, if you can maybe provide a comment on the type of patients population where you see BREXAFEMME really providing different solution.

Yes, Marco, I would echo what you're saying, and there is a diverse group of women. And remember that the average women who has an uncomplicated minor infection is not coming to the clinician for a prescription. They are going to the store. They are buying something over the counter. They're trying all kinds of different things. But remember that the trend is now more moderate to severe symptomatology that is coming in. And I think every woman has experienced the yeast infection. Every man has experienced a woman who's had a yeast infection as well. So the impact factor is very, very important. So the -- I think the extent of the disease, we're seeing a trend towards moderate to severe symptoms. They come in as a last resort because they're so uncomfortable, they have so much symptoms. So this is something that you want to eradicate quickly. And again, it's not something minor to be disregarded. So the everyday woman who comes in, if she has a minor infection, she's not coming into the clinician. The ones that are complicated and moderate to severe, which is the majority of those visits that we said are the ones that are potential candidates for that. In addition, you have a whole group of women. Even women who are on oral contraceptives, they're more predisposed to getting infections. And this is something that can help with recurrence. Remember the 25-day issue. So very often, I'll see a woman now and she'll be on Diflucan and then she'll call me back in 2 weeks and say my symptoms are back. So again, individualizing. So I think it is certainly an opportunity, Marco, for frontline, first-line therapy. Because we're early adopters, we're innovative, we want to treat our patients effectively. We've had a bad experience with fluconazole. I mean that's the reality. I mean it doesn't work. 70% of our patients are going to need multiple doses. So it's kind of this learned concept that it's not working, so let's try something different. In addition, for full disclosure, I've run a high-risk clinic, So people who come to see me have to have a chronic condition. They have diabetes, they have lupus, they have rheumatoid arthritis, they have breast cancer, colon cancer, what have you. These women are living longer, they're much more at risk. I mean I'm seeing a huge trend of diabetes, with obesity at its peak, 60% of all women are obese or morbidly obese. And the incidence of the yeast infections in this population is huge. So again, I think that there are multiple targeted patient populations that would certainly benefit from this day 1.

Thank you. Thank you, Dr. Krychman. Thank you, Dana, for your questions.

Our next question comes from Oren Livnat from H.C. Wainwright.

Oren, you need to unmute yourself.

So I'm dialed in by phone. Can you hear me now?

Yes.

Yes.

Great. I'm technically challenged. So I have a few questions. Dr. Krychman, I understand you're in a pretty intensive practice there, but I'm going to ask you to speculate and maybe Christine as well. Across the broader population of treating physicians in the community, what do you think the awareness or anticipation level already for this product is, if any? And to what extent do you think physicians will be willing to work for these prescriptions early on. Obviously, Christine, you're putting a bunch of stuff in place to help them along that way. But what is the OB/GYN and nurse practitioner experience historically with prior ops and dealing with new branded launches? And how do you think this one will play out? And I have a follow-up.

Okay. So thank you, Oren, for your question. Let me actually here bring in Dr. Krychman. If I understand correctly your question, you would like to get a sense of what can be the type of -- the way BREXAFEMME will -- is being seen or will be seen by the medical community. I think as Dr. Krychman commented before, but maybe I can spend a few more words on his own experience and his own expectation with his colleagues.

So just for clarification, I have 4 clinical offices. So I have a high-risk group. I also I'm in the trenches and see the everyday women as well. So I think your point, Oren, is very well taken. That certainly, execution of a new drug is certainly vital. And I mean, I think that's pretty consistent, the feedback that the company has gotten from the community. But I am fortunate enough to travel, I speak extensively in a lot of different conferences. I just came back from 1 this past weekend, where we were talking about what's new in OB/GYN and BREXAFEMME did come up. And this was nurse practitioners, PAs, OB/GYNs, it was nurse practitioners, women's health. And there is an overwhelming sense of kind of relief that there's going to something new and exciting. I'm not going to say that there's not going to be some barriers. I certainly -- I'm not a big fan. I'll be honest with you. I'm not big fan of prior auth, but I think I'm dedicated to patient care and personalized care. I have -- I know how to get those executed, I have support staff. I think that in this situation, clinicians will go the extra mile. It's not like we have 17 other opportunities that don't require a prior auth. I don't require a little more leg work. We have nothing, zero. We have the same old, same old. So yes, it may appear to be cumbersome on the outside. But I think the timing is right. There is there -- it's -- it is a different situation when you, let's say, you're talking about menopausal vaginal dryness, where there's a gazillion choices that take 2 seconds, they all work. They're all very effective. They're all not going to be a nuisance. They're all well tolerated. And then this new kid on the block comes up with a prior auth. I will be honest, yes, that's going to be a challenge. This doesn't have anything else that is worthy of my time to be helpful for patients. So I agree, but clinicians will pick and choose the opportunities to go the extra mile. And that said, I will tell you, I am very vocal with the company to make ease of execution very, very important. And I think speaking with everybody from Marco to Eric to Christine to the other people behind the scenes, they get it. They understand that -- you can have the best thing since sliced bread, but the execution is going to be paramount. And they've really committed to making that an easy process for clinicians to bring forward to their patients.

Thank you. Thank you, Dr. Krychman and thank you for the kind words. But certainly, this is the way we feel. We have put together a team really for execute -- to make sure that we execute flawlessly on our commercial plans. So Christine, maybe you can jump in and here talking a little bit about how we are going to make sure we have a broad awareness about the product. And of course, being the first movers, it's a big advantage since we will be the only voice. And how OB/GYN historically have been reactive to new products. Maybe you can share some of your thoughts, Christine.

Yes. Thank you so much. And Dr. Krychman covered it beautifully. The team has done a lot of work throughout the year. I just want to call us back to those 12,000 doctors that signed up on the website to learn more about a new option. I mean that is very strong. I've done maneuvers like that previously in other categories. 12,000 doctors signing up to learn more about an agent, a new agent is a really strong signal on what I would say is motivation. And that's what Dr. Krychman not only is he saying, but he's also demonstrating. You can see his energy and his motivation, and that's -- and he's an OB/GYN. That's what we've seen in advisory boards, Marco, to primary research. And we said that we've spoken in research to 1,600 HCPs and payers, too, to talk about this new option. And the motivation is very high. And I think it's because they realize how much suffering is going on with the patient. You see Dr. Krychman saying, he doesn't like prior auth, no one does, but he is motivated to do what he can to help his patient. So yes, I mean we start with motivation. That's awesome. It's on us to get the awareness out there. That's why you stand up a sales organization. And I think the team has done a beautiful job in finding where those territories or the geographies are placing our sales representatives there and exquisitely focusing on the top-tier physicians that are treating these patients. That's really job one initially and for a while. And as we go, we generate awareness and physicians start using BREXAFEMME, they get more familiar with it. I mean, you guys are both doctors, you know what it feels like once you get your own practical experience under you start expanding your use. And then the demand gets signaled with the payers. And then as that happens, we're having conversations, our national account directors for having conversations with these payers about this product and coverage. And so it's a bit of a machine, it's a bit of a cycle, but you do have to start with job one, which is clearly communicate to these important physicians who are treating the majority of these VVC patients, clearly communicate what BREXAFEMME is for them and allow them to get some utility and experience. Hope that's helpful.

Thank you, Christine. And as I mentioned in my introduction, which is there are many, many examples. New drug of a new class with a new mechanism entering in a generic market with some all the generics and doing very well because this is what I think Dr. Krychman mentioned before, the importance of having different tools in your tool set to approach the patients. Thank you very much, Oren, for your question.

If you don't mind, if I could just ask Christine to just expand a little bit. I think it's clear that experience, you and Dr. Krychman made that clear, that's crucial, right, especially to get first-line use ultimately and grow over time. So early on, how do you balance access with the need to sort of drive prior auth demand at the payer side so they're sort of inclined to cover you, right? Are you contemplating any sort of free drug program to have a zero friction experience or I don't think you mentioned sampling or I missed it in the initial presentation. How are we going to make sure docs get experience with or without prior auth?

Yes. Thank you, Oren. I mean the best way to help the physician get experience is to be very convincing and clear on the products' attributes and where it fits into his or her patient population, right? Once they get 1 patient in and they get the experience under their belt, that's when the expansion happens organically. We've been working -- as it relates to coverage, we've been working for some time now, our national account directors with payers to get us well positioned over time so that we will have that coverage. So that work is going on right now. In the meantime, it's almost like a -- it is a cycle where we want to get physicians to try BREXAFEMME in the appropriate patients so they can get their utility and experience. And then again, like I said, that demand starts to get signaled over to the payers while we were having conversations with them. So hopefully, that's helpful.

Okay. Can you sample the product? There's no reason you can't, right?

Sampling, I apologize, I wanted to address that conversation. For a 1-day acute treatment, Oren, it really is strategically, you want to be careful and thoughtful about how you sample. So we do have a small, very strategic early experience kit for those high riders and that will be part of our early launch.

Our next question comes from Michael Higgins from Ladenburg.

And Christine, congrats on pulling this off in relatively short order. There's a lot going on for you and your team. A couple of follow-ups for you, if I could. You mentioned 60 territories. I believe it's a 70-person sales team. How many are in the field versus internal? Is that the 60 and 10? Then also, it sounds like you're targeting 89% of the market. I believe that is in volume is what I'm guessing. If you could just expand on those things.

Yes. Thank you so much, Michael. I appreciate that. Yes, the 60 field reps on the ground seeing physicians face-to-face and then 10 inside sales reps. And if there's a follow-up there, let me know. And the 89% is on market volume in the geographies of the VVC prescription market.

Right. That's super helpful. I guess my follow-up to that, I guess, 2 parts. What can you share for us on the cycling for the reps? Is it every 3, maybe 4 weeks that they're back in these offices? And then from your internal estimates, if you can share this, where do you expect the return to come from, not on a dollar basis, but on a script basis, on a rep basis? I guess how much volume do you think you'll get from a rep versus the internal efforts?

Yes. On the routing, that's a great question. I mean we will use our usual and customary models for community or physicians out in a community versus hospital. Those are different. But given coming out of pandemic, to be honest with you, I led a sales team through the pandemic. There's a lot yet to be seen on how these offices are going to function. So we'll have a model that we will send the representatives out, and we will have really monitors in place to check and see our ability to be able to see these physicians live. And if not, we have virtual capability, and then we'll take a look at that as well. So I think over time, Michael, we'll have a better understanding of what I would call a solid routing plan. To be honest with you, in launches, that happens, too. But in this one, specifically, since we're going out immediately following the opening of the environment, I think we're going to learn a lot of things. I'll say one other thing. The inside sales will be tremendously helpful to that -- to many things but to that cause in that we will have inside sales do some calling ahead of the field teams to kind of understand what's exactly happening out there in the top tier call targets to top deciles. And then I missed your last -- what was your last question?

Just on the reps and the ROI at least on a rep basis, where you think you may get more of a response?

Meaning, the different physician types or over time?

Physician types as well as just the adoption. I know it's hard to answer in a kind of a blanket way because the adoption curves are so different for the...

Yes. Yes. And you're talking about between the in-person and the inside sales. Yes. I mean, listen, face-to-face is king. That's for sure. It's the strongest promotion. That's why it's still around as a tool. But we have learned a lot of things between, I'll call them, 2 promotional levers, the inside sales as well as the face-to-face, and then in combination as well, Michael. And then one last thing. I mean we'll have surround-sound digital advertising, brand campaigns. Those will lift what's called share of voice. And ultimately, over time, that noise for the BREXAFEMME brand will all come together and help over time as well.

And Christine, if you don't mind, I could just jump in. I just did a live conference this past weekend, and we had 251 participants and 50 people on the waiting list to get in. So we are returning rapidly to the pre-COVID educational paradigm of in-person conferences. People are certainly seeing representatives. Again, I think the climate in the United States is evolving very rapidly with increased vaccination and increased frustration with being bottled up. So I think we are much more inclined to meet with representatives. The challenges still exist there with some of the limitations that have always been limitations with access. But I think people are going to conferences. They're still reading journals. There are still new and exciting opportunities to get your message out to clinicians who are very hungry to learn about new things and break out of the pandemic box, so to speak.

Well, that's good because we will be in all of those channels. So that's good.

That's a great color. One follow-up, if I could. Christine, you mentioned 12,000 health care petitioners visiting Rethink VVC. Are you able to track those? Are they just visits to the site? Are you able to actually identify who they are and reach out to them?

Yes, I mean it's an opt-in. They can give more information and we can collect that in a database. We love doing those types of things to continue a line of communication with those physicians. And then ultimately, they go down different lines of communications. They may even want to see a rep. And if they do, we're happy to send one. So yes. Thank you.

Our next question comes from Steve Brozak from WBB Securities.

Congrats on this presentation. It's really very, very helpful in getting everything out in one place. Dr. Krychman, you have mentioned you saw 70% resistance rates on azoles. Can you -- any rule of thumb as to how many visits that would translate from patients prior to even seeing you and how many visits it would take to resolve these patients' issues? And I've got a couple of follow-ups after that, please.

So I think the question that's really important is, on average, a woman will come in when her symptoms are moderate to severe. So that's the first initial. Not uncommon that she will come in again within the first little while. And I think the visits have increased, the number of visits have increased because, don't forget, we have to factor in telehealth. It's also the landscape has changed. 30% of all health care delivery will now be by telehealth, which is really problematic when you talk about adequate optimal treatment of VVC because you really need to look and see the quality, characteristics, the discharge, the symptomatology, and that cannot be gleaned by the telehealth visit. So a telehealth visit is not uncommon for the first one and the paradigm is come in and see me a second time. I certainly have people that come in, in 3 to 4 visits. And this could be over the course of 2 months because even after they're effectively treated, you want to make sure that they don't have any kind of residual issues thereafter. So the economic burden of multiple visits is not -- shouldn't be underestimated with that. So like for me, as a clinician, when you factor in all those other issues, it becomes very, very interesting to be able to get people effectively treated immediately. And I can tell you, I have a 3-month waiting list to get into my office because people have delayed care, people are not adequately assessed over telehealth. So if I can free up and treat people effectively, I think that will be really important. And I've already said, I think just my -- from my clinical experience, I think it may be something -- if I see a woman on telehealth and I know her and I have a very good understanding of what her issues are, I may choose BREXAFEMME over fluconazole as the initial treatment because I know it's safe and effective, and it will be -- has shown efficacy at 25 days contrary to -- versus choosing Diflucan, which I know I have a -- it's kind of a crapshoot. I'm going to more than likely have to see her again and not be aware if I've adequately treated her or not. So I think the landscape that we have created with the pandemic has really changed the face of VVC. We know that STIs and VVC will become a huge issue in terms of treatment over the telephone. And we've been doing that before. So I think the issue is that it certainly will amount to many more visits. So I would guesstimate 3 to 4 visits as opposed to 1 visit with BREXAFEMME.

So in going back to that, how many types of clinicians are typically going to be involved just for your practice before you -- before they see you, ID docs, general practitioners. How many...

So they first -- the first doctor that they see is called Dr. Google. So they'll see the Internet, and they will decide what they have and how to treat that effectively. In a major metropolitan area like where I live, it's not uncommon for women to have OB/GYNs or nurse practitioners. Very often, they'll see their primary care clinician. So there's great opportunity for diversity of clinicians to be seen. I think the challenge that we're seeing now is access to care. So more and more people are getting access by telehealth, remote medical care. So they do see a diversity of specialists. I happen to be a tertiary referral, but I would say that even though I'm a tertiary referral, about 50% or 60% of the patients that see me end up converting to becoming regular GYN patients after I address their issues. So I think the ID doc is down the road. The VVC patient is -- the face of VVC is really this learned helplessness. They've gone to learn that it's kind of normal to have a burning vagina or irritated or red [indiscernible] symptoms. So by the time they go to a clinician, they're moderately to severe in terms of this, and it's really unbearable. So they see a diversity of patients really dependent on access. And I mean there's a lot of OB/GYNs all over the place but nurse practitioners, primary care are also entry level, I would say, less so. But with that caveat, Steve, I said, very often what I've been doing, if I have really tough cases that I've had challenges to treat for chronic yeast infections, I've referred them to ID. So this will mean for me that I'll have less and less patients to refer out of my clinic and keep them more within the confines of the center that I'm running.

So you had mentioned one thing, our clinicians -- typically, when they have patients that are on antibiotics, you mentioned the Diflucan 25-day problem or the 25-day call, after a patient is treated with any kind of antibiotic that happens to have a predisposition to fungal infections, a lot of the times, the clinicians that are treating them will just prophylactically give them an azole. What do you think about these types of patients, not to prophylactically give them a BREXA, but to be able to understand that there's another option here for them? What are your thoughts there?

Well, I think I was involved with discussions, as Christine had said, with the company. And again, it's not uncommon, people will get a prophylactic antibiotic therapy. They're going on vacation, they get a UTI, they want some antibiotics. And very often, they're getting multiple courses of this Diflucan because they haven't. So because the -- one dose doesn't work. So I know if somebody is going to be on vacation and get a UTI and get antibiotics, I want to make sure that they're not having compounded symptomatology. So you are 100% correct that this is certainly an opportunity for the vacation prescription, the prophylactic prescription after chronic antibiotics, whether it's for a URI or what have you. We've seen that very -- it's not uncommon. Especially with COVID-19, we've seen a lot of women have respiratory issues. They've been on multiple antibiotics. And then they present not with those symptoms but with persistent yeast. And I think the concept to remember is that the majority of women will need multiple doses, they'll need multiple visits. So having an option like BREXAFEMME certainly will be a good opportunity for that segment of patients who are taking antibiotics, whether chronically or episodically, for a variety of reasons and want to prevent a yeast infection.

One last question for you, doctor. Can you give us any insight in terms of age distribution and especially as you start to see the comorbidity impact that takes place? What are you looking at in terms of -- who are these patients that are obviously coming back repeatedly now?

So the people that are coming back, I would say, it's the over-40 crowd. Hormones become tenuous at 40, where they wax and wane. The whole concept of maintaining your vaginal pH is really based on estrogen. And a woman gets into the perimenopause in her 40s, about 10 years before she actually stops her period. If you think about it, Steve, we're getting better at diagnosing chronic conditions. 25% of all breast cancers happen before the age of 45. We're getting better at screening in terms of diabetes. So really, the over-40 crowd is really those that are going to be having chronic conditions as well as have this predisposition to have yeast infections. That being said, I would even -- I don't want to forget about the childbearing woman, right, the woman who's had a baby, she's breastfeeding, she is doing a variety of different things. Young women get yeast infections as well, and the biggest culprit for that is oral contraceptives, right? So over 30 million women internationally are using oral contraceptives, and they're predisposed. So while my patient population is over 40, let's not forget that there's other women that are certainly appropriate candidates for this.

One last question for Christine. Can you -- out of the 12,000 docs that came in, how many were outside of the -- were outside of the OB/GYN universe that you saw? And thanks again for answering these questions.

The majority were OB/GYNs, and the balance were some of the NPs and PAs.

Yes. I'll now turn the call over to you, Marco, to read any questions that may have come over the webcast.

Okay. So actually, we have received probably more than 3 dozen questions from -- written questions. Theoretically, we were supposed actually to stop at 1:30, but I would like just to go to some of these questions because they are excellent questions, and we would like to address as many as we can maybe taking a few extra minutes beyond 1:30. Let me start with the -- the first question, actually, we received was, what is the most important value BREXAFEMME brings to the antifungal market? And I will say that there are 2 levels. One, as -- ibrexafungerp as an antifungal itself is a new class, a new class that will make a difference in the community and in the hospital. And in the -- and as a BREXAFEMME, so as a specific antifungal for the treatment of vulvovaginal candidiasis, you have heard by Dr. Krychman, and you have noticed from Christine, from our interviews with doctors that there is a need for a new product, a new product that really provide an alternative to the azole mechanism. Only azoles have been used for the last 40 years. I think it's time for a new class. And we will bring a product which is fungicidal. In other words, it kills the pathogen. It's not fungistatic, like, azoles that just block the growth. And it's a product that now is approved for a broad group of patients -- outpatients. We had also several questions asking about the contraindication that we had in our labeling. We had actually -- let me start saying that we have been very pleased with our labeling. It really highlights all the positive and important attribute of the trial, like, being fungicidal, like being active against a variety of different pathogens, by having also the results of 25 days, which is an important parameter, as you have heard also from Dr. Krychman. We had very limited -- there are 2 limitations. One was, of course, the usual contraindication for any kind of hypersensitivity to the product, and the other was pregnancy. Pregnancy was based on animal studies. FDA has taken a conservative view about the product, about the toxicology studies and to tell you that we understand the rationale. And we don't think -- and actually, let me make very clear, we don't anticipate that this contraindication will have any significant impact on our BREXAFEMME forecast for a very simple reason. It was never, never our assumption that BREXAFEMME would be promoted or used in pregnant women. It's something that it was never a part of our plan. So the contraindication we don't expect to have any major impact. We -- sorry, I'm jumping very quickly from question to question for the sake of time. We had also several questions asking our business development plans. As we mentioned recently, in March, we had a very important partnership with Hansoh Pharmaceutical, one of the public biotech companies in China, and we out-licensed the rights for Greater China to Hansoh, one of the best deals actually that has been seen for Greater China in our sector. This is actually a deal we are very proud of. And as you may expect, since we have rights -- worldwide rights, discussions have been intensifying since the time when the FDA accepted the NDA in December and when it approved the NDA on June 1. So stay tuned. We are not providing any specific guidance, but certainly, our plan, and as we have shown with China, is really to monetize our rights outside of the U.S. and, therefore, we would continue to work diligently to find proper partners that can maximize the value of the product in their regions. Many of the questions we received was also a question about the -- how can a product that will cost as a WAC cost of $475 compete with generic fluconazole that will cost $10 or less? Well, we've been stressing this throughout all the presentation. But the problem here is not cost, it is actually resolving the problem in women where the generic fluconazole that has been around for almost 3 decades is not any longer addressing the need of the patients. And therefore, we are not here trying to replace fluconazole. We are trying to address the needs of the millions of women where fluconazole is not any longer the right product. And I brought as an example, for example, when ACE inhibitors entered in the -- for hypertension, they did not replace beta-blockers, they just simply were an alternative solution and a solution that commercially was very successful to address the needs in patients, where beta-blockers, for one reason or the other, was not any longer an appropriate solution. We had also some questions. Maybe, Christine, I will bring you here. Many, many questions about -- in the post-COVID world, how is our plan with regards to telehealth, with regards to telepharmacy? What are our plans? So Christine, I will bring you in for a very quick comment about this type of issues.

Yes. Thank you so much. Telehealth definitely has come up as a -- has emerged as a new way of seeing patients. Dr. Krychman gave some great overview on it. We will have a telemedicine program. Patients, if they're interested, can go into our BREXAFEMME website and get to a telehealth program from there. I think we're going to learn a lot, Marco, to be honest with you. It is a new emerging channel. And I think definitely in pandemic, we all learned a lot about it. But how it continues on as we come out of pandemic is going to be interesting because you heard Dr. Krychman state that doctors are getting back to seeing patients live and seeing drug representatives as well. So I don't think we're going to have an all -- or one size fits all, as you say, program. We'll have to take a look, and we have some great measurement on it, Marco, and we'll come back and report how it goes and what we've learned about it.

Thank you. Thank you, Christine. We had also a few questions all focused on the -- asking what is the potential threat from future competitor and, namely, Mycovia. Mycovia is a company which is developing a nasal for the treatment of recurrent VVC. First of all, let me make very clear that we wish well to Mycovia because, simply, as Dr. Krychman was saying, there has been so few -- so little innovation actually, no innovation whatsoever for the last 25-plus years. So we wish them well. The approach our company has taken has been somewhat different from that of Mycovia. We have decided that a product that has a novel mechanism of action, a product that belongs to a new class, a product that is fungicidal will have a better -- will have a good reception by patients and doctors. And therefore, we -- this is where we have focused our efforts, and we are not certainly in a position right now to comment or to make up any speculation on how and when the Mycovia product would be approved. There has been also some questions regarding -- Eric, maybe jumping in for you also. What will we report in the future on a quarterly basis in terms of -- on our sales and our commercial progress?

Yes, Marco. Thank you. Absolutely. We will report, as we normally do as part of our quarterly filings -- SEC quarterly filings, we will report our usual financials where revenue line will be disclosed on an ongoing basis. And certainly, a lot more clarity will be provided in 2022 as far as guidance going forward for consensus. But on an ongoing basis, our operating expense as well as revenue lines will be disclosed, and we'll add some qualitative comments to this. And this will be done on a quarterly basis.

Thank you, Eric. We had also several questions actually. First, by listeners who certainly are very happy to see BREXAFEMME being approved and launched, but they also are asking questions about progress in the hospital indication; some cases, clearly, also making specific mention of conditions that probably they consider conditions that have not been able to try good products, like, for example, conditions like chronic mucosal candidiasis. I think we will talk more in the future, specifically for our progress in the hospital. Just suffice to say that we continue to be interested and we continue to progress very actively in the hospital field. As you may know, an intravenous formulation is in Phase I. We have 3 programs in the hospital indication, and we will continue to develop also the hospital because it's an important way for ibrexafungerp not only to create value for shareholders but also to treat patients that right now may not have any other options. We are now approaching the 50 minutes beyond our time. So at this point, I would like just to make a few final remarks, and taking the opportunity, I'd like to thank everyone. I really hope that you are leaving this event with 4 key takeaways. First, that we are launching an innovative and differentiated product in an indication where there is a great need for something new and different, as you have heard from Dr. Krychman. We are also operationally ready to launch BREXAFEMME, as you have heard from Christine Coyne, our Chief Commercial Officer. We have the funds and the resources for the launch with a cash runway into 2023, as you have heard from Eric Francois, our Chief Financial Officer. And as I mentioned before, lastly, we will continue to work to maximize the full potential of ibrexafungerp in the community and in the hospital setting for the benefit of the patients and to create value for our shareholders. So thank you very much for your attention and have a wonderful day. Operator, you can close the session.

Thank you, Marco. This concludes today's conference call. You may now disconnect.