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

Greetings, and welcome to the SCYNEXIS post-approval investor call for BREXAFEMME. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Ms. Irina Koffler with LifeSci Advisors. Thank you. You may begin.

Good morning, and thank you for joining us as we provide a key corporate update on the FDA approval of BREXAFEMME for the treatment of VVC. Joining me today from SCYNEXIS are Dr. Marco Taglietti, President and Chief Executive Officer; Dr. David Angulo, Chief Medical Officer; and Christine Coyne, Chief Commercial 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 would like to turn the call over to Marco for his opening remarks.

Thank you, Irina. Good morning to all. [Foreign Language] Today is an extraordinary special day for SCYNEXIS, a day for which we have been working diligently and so hard for the last few years. I cannot easily find the words to convey all our excitement and delight in announcing the approval of ibrexafungerp, trade name BREXAFEMME, for the treatment of vulvovaginal candidiasis, or VVC, also known as vaginal yeast infections. Today, it's a big day for women who suffer from this condition. I'm incredibly proud of my team that in this difficult and challenging times, was able to complete the Phase III program and to file the NDA last year on schedule. The quality of our NDA and the strength of our data is validated by the fact that FDA has approved BREXAFEMME on time by the PDUFA date without the meaning of an advisory committee. Most importantly, we believe the approval of BREXAFEMME for the treatment of VVC is just the beginning. It is the first of many other approvals for ibrexafungerp that we expect to come in the future. Our life cycle plans for ibrexafungerp are anticipated to result in a stream of approvals over the next years, expanding the usual ibrexafungerp in different indications in both the community and the hospital settings. In fact, we believe that ibrexafungerp will evolve into a major long-lasting antifungal franchise. Ibrexafungerp is the first representative of another class of antifungals. Last time that a new class of antifungals was introduced was 20 years ago with the echinocandins. And the last time that the new class of antifungals, orally bioavailable was introduced was more than 40 years ago with the azoles. It was just about time to finally bring real innovation in the field of antifungals with a new class of compound, the fungerps. Ibrexafungerp is innovation. Innovation for the patient. But it is also good business. With 10 years of regulatory exclusivity and patent protection for composition of metal, until 2035. ibrexafungerp expects to enjoy at least 14 years of exclusivity, allowing us to create an enduring, profitable antifungal franchise. In a moment, Dr. David Angulo, our Chief Medical Officer, will walk you through an analysis of the different sections of the approved BREXAFEMME labeling, highlighting the important features of the drug and how we envision BREXAFEMME to address the need of the large underserved VVC market where there is only 1 oral product approved, fluconazole, and it was approved more than 25 years ago. We plan to launch BREXAFEMME in the U.S. in the second half of this year. As communicated in the past, we expect BREXAFEMME to achieve peak net sales of $400 million to $600 million in VVC alone. And based on this labeling, we are confident in our ability to achieve these numbers. Christine Coyne, our recently appointed Chief Commercial Officer, will share a few high-level thoughts about our commercial perspectives. But since June, on June 29, we will provide a comprehensive overview of our commercial plans during the virtual Investor Day meeting. Finally, we have recently strengthened our cash position and currently have over $100 million pro forma cash to execute our launch with a cash runway into 2023. I want to make a few important points on this other slide. First, the dose of systemic antifungals. There is only a handler systemic antifungals across 3 classes that have been introduced decades ago. The polyenes in the late 50s, more than 50 years ago, the Azoles, the most successful antifungal class available intravenously and orally for community and hospital infections was introduced in the '80s, 40 years ago. And finally, 20 years ago, in 2000, the echinocandins. It is really time for a new class of antifungals. The second point I want to make is that following the timeless law of supply and demand, all systemic antifungals have done extremely well commercially, especially the first representatives of the class because there are so few antifungal options available, and we believe that ibrexafungerp within all sections. And that brings me to a third point. That antifungal space has historically been dominated primarily by large pharmaceutical companies. We're seeing a great opportunity for such antifungal products, both in the community and in the hospital settings, as shown by the recent acquisition of Amplity, a private company with a systemic antifungal in Phase II by Pfizer. And so -- and this is my final point. You can appreciate the commercial potential of a new systemic antifungal with the versatility of ibrexafungerp with an oral formulation and the broad-spectrum activity also against worst fungi that have developed resistance to the currently available systemic antifungals over the last few decades. And this is why, personally, as an infection disease specialist by training, I'm so proud, being associated with the introduction of a new class of antifungals into the medical practice. We view ibrexafungerp approval in vulvovaginal candidiasis as the first step of a much broader opportunity as we continue to advance the development of ibrexafungerp in treatment of refractory and hospital population as well as to conduct testing of an intravenous formulation. And now I will turn it over to Dr. David Angulo, who will walk you through the key elements of the label. David?

Thank you, Marco. We are very pleased to share with you the first approval of the novel antifungal agent ibrexafungerp that will be commercialized under the name BREXAFEMME for the treatment of vulvovaginal candidiasis, or VVC. I share Marco's excitement to bring to the market a novel class of antifungal and a much needed treatment alternative to millions of women suffering from VVC. VVC commonly known as vaginal yeast infection is caused by a disease called Candida. Typical VVC symptoms include itching, vaginal irritation, burning sensation, aberrations of vaginal mucosa and abnormal vaginal discharge. Most women will have at least 1 episode of sort of this in their lifetime, and 40% and 50% to 50% of them will experience multiple episodes. VVC can be associated with substantial morbidity, including significant genital discomfort, reduce sexual pressure and activity, psychological distress and embarrassment, reduce physical activity and loss of productivity. The treatment options are limited to topical antifungal products. And prior to this day, only 1 oral antifungal approved for VVC, fluconazole. We are excited to provide a new oral One day treatment option for patients affected by this condition. I will now go over to key elements of the BREXAFEMME enabling. As many of you know, a product labeling adequately suited to patients and market needs is critical for the purpose of commercializing a drug and negotiating its formulary placement with hospital decision-makers. We are very pleased with the differentiated label that we have with BREXAFEMME that clearly communicates the most relevant product attributes and provides prescribers with the information they need to consider BREXAFEMME for their patients. The indication approved treatment of VVC allows the use of BREXAFEMME in a broad setting, treatment of any VVC episodes. The age range includes from pediatric females after their first menses, typically around 12 years old to adulthood, which are the ages commonly affected by this condition. Key differentiating attributes are illustrated in the labeling, including the novel mechanism of action that results in fungicidal activity against Candida and activity against fluconazole-resistant strains. Convenient dosing, 2 tablets, taken 2 times in 1 day, demonstrated efficacy from 2 large well-controlled clinical trials, using a very robust definition of success, complete resolution of all signs and symptoms. The limitations of use are few, and include pregnancy and hypersensitivity to ibrexafungerp. And an attractive tolerability profile, with most adverse events being manageable gastrointestinal disturbances and no serious adverse reactions. Let me provide further detail regarding these key aspects of the labeling. As mentioned before, BREXAFEMME is a 1-day oral dose regimen. With 2 doses of 300 milligrams administered approximately 12 hours apart, and the drug can be administered with or without food. Ibrexafungerp is a glucan synthase inhibitor and prevents the formation of an essential component of the fungal cell wall. This mechanism of action gives BREXAFEMME its unique antifungal attributes, including concentration-dependent fungicidal activity against Candida as demonstrated in time-kill studies. In vitro, ibrexafungerp has activity against most fluconazole-resistant candidate strains and retains activity in pH of 4.5, the normal vaginal pH. In our Phase III studies, VVC demonstrated clinical efficacy against Candida albicans isolates. And ibrexafungerp has in vitro activity against non-albicans Candida species, including Candida auris, Candida glabrata, krusei, tropicalis and others, which include the most common clinical relevant stations. The clinical significance of these in vitro observations is still not known. But we view these findings as encouraging and hope to accumulate more clinical data on these organisms in ongoing BREXAFEMME on their trials. The efficacy of BREXAFEMME in VVC was demonstrated in 2 large randomized, placebo-controlled trials. Patients had evidence of symptomatic VVC with a sign and symptom score of at least 4. On a scale that goes from 0 to 18 that considers itching, burning irritation, redness, swelling and excoriations. With ratings of 0 to 3 from absent to severe from -- for each sign and symptom. They also needed to have a positive microscopic examination showing GIST and normal vaginal pH, typical of VVC. The median VVC score at baseline was 9 and 10, for the studies 1 and 2, indicating a very symptomatic condition at baseline, mostly moderate to severe. The primary analysis was conducted in patients with culture-confirmed VVC, mITT, in line with the FDA guidance. In addition to the primary endpoint, key secondary end points are also displayed in the approved labeling, which is important for prescribers when evaluating this novel treatment option for their patients. Having significant clinical data displayed in the labeling also allows more impactful marketing messages. As illustrated in the label in both studies, one conducted in the United States and another in the U.S. in Bulgaria, BREXAFEMME showed a higher rate of complete clinical response, which is a complete resolution of all signs and symptoms at both the test of cure visit occurring around day 10 and the follow-up visit occurring around day 25. BREXAFEMME also showed a greater percentage of negative cultures at the test of cure visit. All these response rates were statistically significant versus placebo. The results in both studies consistently showed the clinical and microbiological efficacy of BREXAFEMME and serve as the basis for this approval. Following up with key safety aspects of the labeling, BREXAFEMME is contraindicated in pregnancy and in patients with hypersensitivity to ibrexafungerp. On an animal study, BREXAFEMME may cause fetal harm and for patients of reproductive potential, prescribers should use common standard medical practice to verify pregnancy status before initiating treatment. And patients should be advised to use a contraceptive method while receiving BREXAFEMME. Regarding the tolerability of BREXAFEMME, there were no serious adverse reactions in the studies. The most common adverse reactions with frequencies that you can see in this slide were diarrhea, nausea, abdominal pain, dizziness and vomiting. The drug interaction sections of our labeling provides short and easy to follow recommendations. Ibrexafungerp metabolized the CYP3A4 enzymes. And as such, concomitant use of strong inhibitors of these enzymes increases the exposure of ibrexafungerp. A dose adjustment is required when BREXAFEMME is co-administered with a strong CYP3A4 inhibitors. Additionally, inducers of CYP3A4 may reduce the exposure of ibrexafungerp and may affect efficacy. For that reason, co-administration of BREXAFEMME with a strong and moderate CYP3A inducers should be avoided. This language is common in drug labels and helps physicians to guide patients through dosing in these special circumstances that we estimate will be uncommon. There are no other drug interactions that are considered of clinical significance to require any recommendation in the label. And now I would like to turn the call over to Christine to briefly review our commercial readiness, and what you can expect next.

Thank you, David. It is with great excitement and pride that I joined the SCYNEXIS team to launch this important product, BREXAFEMME. In my career, I've had the honor of launching many products successfully. And while all launches are exciting, it is especially exciting when there is a clear unmet need in the medical community where physicians and their patients are waiting for much needed options as is the case for BREXAFEMME. Our team has been hard at work developing the foundation for a solid launch with a strong commercialization infrastructure behind it. Key commercial components are well underway and all is going to -- according to plan. We are pleased to have partnered with Amplity who's proven launch track record, especially with companies of our size, is a critical success factor in our journey to commercialization. Our commercial team, along with Amplity have built the field leadership foundation for both payers and physicians. The payer account teams have already been very active with their key customers. All executional efforts are underpinned by the work the brand team has done to help communicate the important features and benefits of BREXAFEMME to all our key stakeholders. And lastly, the trade and distribution team is diligently operationalizing their plans to ensure access to BREXAFEMME to appropriate patients who need it. It is an exciting time, and the energy coming from the commercial teams and our customers is growing daily. We look forward to discussing more details with you on June 29 at our Investor Day. I will now turn the call back to Marco. Thank you.

Thank you, David. Thank you, Christine. Before we open the call to questions, I would like to recap our broader vision to build a leadership position in the antifungal category. First, we have now secured our first FDA approval for ibrexafungerp as BREXAFEMME for the treatment of VVC. This is a fundamental corporate milestone. Second, we have raised enough capital, and importantly, have access to capital to support the BREXAFEMME U.S. launch, while we continue development at full speed in other indications, with a cash runway into 2023. We also have validated the value of a systemic antifungal like ibrexafungerp beyond the United States through our partnership with Hansoh Pharma as we continue to look for other international partners to continue to expand the use of ibrexafungerp worldwide. Third, we have assembled a first-rate commercial infrastructure, both internally and through Amplity Health to leverage the potential of BREXAFEMME in the women's health field. Fourth, we expect to launch BREXAFEMME in the second half of this year. Remember to join our virtual Investor Day on June 29 to hear more details about our commercial plans. And lastly, our experienced R&D team continue to work to expand the ibrexafungerp label into other indications in order to overcome resistance to aging antifungal therapies that we have developed over the last several decades. We plan to complete our candle study by end of this year with top line results and the supplemental NDA in the first half of 2022, with potential approval of this second indication in the second half of next year. We continue also to focus on the hospital, life-threatening invasive fungal infection with our FURI, CARES and SCYNERGIA studies. Also, we are in Phase I testing our intravenous lyposomal formulation of ibrexafungerp. We are pursuing this additional indication and formulation to maximize the value of ibrexafungerp, which we believe can achieve a significant status similarly to other antifungal predecessors. With that, let us open the call up to your questions. Operator, please go ahead.

[Operator Instructions] Our first question comes from the line of Louise Chen with Cantor Fitzgerald.

Congratulations on the approval. So first question I had was, how are you thinking about pricing for your products? Or when will you reveal the pricing? The second question I had is, can you talk about this prevention indication and how it compares in size to the indication you've got approval for today? And then a question that we often get from investors is the OTC market versus the Rx market, can you help us distinguish between the 2, and the advantages of your product over an OTC product?

Okay. Well, you have quite a few questions on your part, you'll remember all of them. So let's start with the pricing question. Well, we actually -- we plan to share more about our thinking and our rationale about our pricing on June 29. So please stay tuned. What we have showed in the past is that we were expecting a pricing range in the $350 to $450 in order to stay below $500 in -- for a course of BREXAFEMME. So stay tuned, June 29. Second, prevention indication. This is actually a very, very good question, Louise. And it's something we've been talking recently a lot. First of all, it's the way doctors actually look at this indication. What they see is an actual case of vulvovaginal candidiasis. So [indiscernible] patients coming in their office with clearly the symptoms of vulvovaginal candidiasis. The distinction with the prevention of recurrent is really when they see a patient really coming more frequently, coming several times, trying many different type of drugs before. So the -- really, the need is really for something that will trick these cases with the efficacy of ibrexafungerp as a fungicidal treatment that can clear the infection. And maybe, David, you can add something about what has been our experience with the treatment of this acute episode.

Sure. Thank you, Marco. Yes, Louise, following to your question there. So the need is immediate, as Marco say has really been able to treat an acute episode, which are very symptomatic and distressing to things. And at the same time, as we are thinking in that population of patients who have recurrent disease, really heavily continuous antifungal suppressive treatment has demonstrated to be beneficial. And that is where the -- our CANDLE study comes in order to provide continued suppressive antifungal therapy to try to prevent these conditions in the -- for those patients who have recurrent condition. What is the -- your question was a little bit about what is kind of the market sizing one versus the other, and I think that that's probably going to be a little bit better elaborated in our upcoming confidence regarding commercial opportunity at the end of June. So probably that question will be better answered in terms of the market opportunity in both segments at that particular call.

And just to add to -- no, sorry, go ahead.

No. No. And I think that the other question was regarding the OTC market versus the prescription market.

So in terms of -- and let me just add one important point that some of our experts have been raising about this difference between the treatment of an episode and the prevention of future episode. Unfortunately, there are some limitations with fluconazole, but that has been well documented in the leisure to and that can be very evident when you look at the labeling of fluconazole, with several patients, but simply they respond initially to the treatment, but as soon as the treatment is over, that is the infection is back. So some of these recurrent cases are more probably just simply episodes that are not treated properly where the infection has not been completely clear because of the mechanism of action of fluconazole, which is fungistatic and not fungicidal. So this is where we expect actually to be more -- providing a treatment that will actually clear the infection and therefore, resolve the episode. And excuse me, Louise, what was your last question?

No. You answered all of my questions.

Our next question comes from the line of Dana Flanders with Guggenheim Partners.

Congratulations on the approval. My first is, did the FDA include any data from your Phase II DOVE study in the label? And just how important do you think it is having that kind of direct comparison to fluconazole in the actual label?

So actually, no it is -- the Phase II data of -- are not in the label. As you know, FDA trying to -- really they include only the pivotal trials. And that's only for the pivotal trial, what they have shown are actually a broad range of data that I think can really help doctors to take a decision, that is we have data factor. First visit, 10 days or 25 days, different endpoints that really will allow a doctor to actually being able to see what is the type of efficacy they should expect with the product. But those studies are not part of the labeling. But they were presented at scientific conferences. And therefore, what we showed is that we have a comparable efficacy to fluconazole in the short terms of 10 days. But really, we show the numerically greater response at the follow-up visit day 25. And this is, again, can be really linked to the fact that fluconazole is a fungistatic and therefore, you can see some patients relapsing between day 10 and day 25, whereas in our case, we saw the infection completely clear. And so having more patients at day 25, where all the lesions have been fully healed.

Okay. Okay. Got it. Understood. And then any more clarity on launch timing. I know you've kept the range to kind of second half of this year. And wondering why you wouldn't be launching nearer-term or if this could push into the fourth quarter at all?

Dana, we want to make sure that you are going to attend our June 29 meeting. So this is why we are keeping this as we finalize our plans and so on. So stay tuned. We, of course, we will provide more directions at the June 29 meeting.

Okay. Okay. And maybe just my last one, and I'm sure you'll give more color at this -- at the June meeting. But just how are you thinking about kind of rep access for in-person marketing. I know the COVID environment is getting much, much better and things seem to be opening up. Are you expecting a fairly kind of normal launch environment when you do get to market? Maybe just talk a little bit about how that's trending relative to kind of your launch plans.

We are definitely assessing the situation. And certainly, I will ask Christine to join in a second. But thanks really to what I will say has been the big effort of the pharma industry in general, with Pfizer, Moderna, J&J, AstraZeneca. I think what we are seeing is moving toward the normalization. And maybe Christine, you can join and tell us about what has been the feedback you have seen in the field and the changes that have been happening pre-COVID, during COVID and maybe how things are moving right now in terms of availability, actually for sales reps to reach out to doctors.

Yes. Happy to. Thank you so much. Thank you for the question, Dana. We do keep a tight vigilance on the environment, how it evolves. And Marco's comments are right. It continually evolves. So happened pre-COVID is not reflected in, obviously, post-COVID and kind of how we coming out of COVID now. It's definitely still in an evolving state. There are areas where there is access and there are areas where physical access of reps to physicians. And there's also areas where there is not. So we will continue with our planned flexibility for the field teams, and we will work very closely with our customers to be able to provide what they need for their patients as the best way we can with their model. So more to come. We'll talk more specifically at June 29. But I think the most important thing is just making sure we understand the environment how it evolves going forward. I hope that's helpful.

Our next question comes from the line of Michael Higgins with Ladenburg Thalmann.

Congratulations from ourselves over here, great job. A question for you, if we can, ahead of the June 29 events and looking forward to having more details come out then. But can you give us a sense on the marketing budgets from Amplity in the first year. So how many reps did they have as a unit, how many of those may be deployed for BREXAFEMME? And any updates on the digital campaign as well would be helpful.

Yes. So Michael, again, thank you for your question. And we -- so let me start with Amplity Health. So first of all, we have been very pleased to -- of our partnership with Amplity Health because they have the great expertise, and they are moving extremely fast. And we are very, again very pleased of this collaboration. Our plan, as we have been mentioning in the past is to have a sales force between 50 to 75 sales reps. With a group of them actually being in-house reps, but really we'll use now the available tools that reps are using. Especially after the COVID situation to reach out to doctors. And of course, we have digital campaigns in thinking about it because this is a group of -- but actually are very internet savvy. These are -- most patients are between 20 to 45, Internet savvy, they use social media and so on. But I will actually ask Christine to again, to maybe provide some high-level photos shared with some of them already, but some high-level thoughts on how she sees the campaign to make BREXAFEMME the success that it deserves to be. Christine?

I agree with all those comments, Marco. And also that our end consumer female patients are very digital savvy. And it's also a condition that really pairs nicely with the self-directed channel of digital. So the team is hard at work on the digital awareness campaign that has been well in play. And we will have the results on June 29, but everything seems to be going to plan. And just I mention on the sales reps as it relates to the earlier question. They are BREXAFEMME-dedicated. So 100% for that product. Hope that's helpful. Thank You.

Okay. That's definitely helpful. One follow-up on the market research that you can share with us so far. What do you expect to be the most common patient type the back half of the year once launched. Is that a patient that's more moderate to severe? Or are those with multiple failures of prior treatments being more so of a bigger group?

Yes. I'm happy to jump in. I think it's a lot of all of it, to be honest with you. And I think the key will be on our ability to be very clear and concise with our physicians as to the patients that they are seeing come through their office. Because quite frankly, when you look at the clinicals that Dr. Angulo walked us through and pair that with primary research coming from our customers. It's just about all of it, to be honest with you. And so the key here will be for us to be clear with our physicians to make sure that we clearly communicate the features and the benefits for their types of patients in their offices. I hope that's helpful.

Our next question comes from the line of Oren Livnat with H.C. Wainwright.

And congrats on a rare first pass approval. It's nice to see one finally. The efficacy seems pretty straightforward. And since you have the June 29 event, I won't ask more about the commercial stuff. But I do think -- I'd be remiss if I didn't ask about the pregnancy contraindication. Back in July, at your KOL Day, I think your practitioners did speak about that was a relevant consideration with fluconazole, the miscarriage risk. So I'm just wondering, I guess, a few questions on this. One, is it a surprise, the language that ended up in the label versus your initial plans? And how might a pregnancy contraindication or pregnancy tests impact, in your mind, physician uptake? And how do you think it will be perceived versus the fluconazole risk-benefit with regards to pregnancy? And I do have one follow-up.

Okay. So thank you very much. And by the way, let me actually comment on your first sentence. It's nice to see. A first pass approval, actually, without the -- an advisory committee that really shows really the strength and the quality of our package. So let me start, first of all, to phrase this overall. That is -- we don't anticipate the contraindication of pregnancy to have a significant impact on our BREXAFEMME forecast. And simply because it was never our assumption that BREXAFEMME would be promoted to or be used in pregnant women. The -- so the -- since we expect actual ibrexafungerp could be used by billion of women. This conservative labeling -- or rather conservative leveling from FDA really helps to minimize the potential risk and liabilities for pregnant women. With regard to the question, if we were sort of bit surprised? Let me just say that we do a lengthy discussion with FDA, as you know, in this type of the negotiation. And we that stand behind our assessment of the tox studies, it's not that there was any kind of new data other than the one we provided to the agency. But FDA has opted for a more, I would say, a rather conservative approach, and that we support. Our focus is really for the women who need the product because fluconazole is not addressing the issue. I think that the rate of failures in women using fluconazole is extremely high. And therefore, this is our focus. And our -- as I mentioned, our forecast never assumed that we were going to use the product in pregnant women. And our discussion also with doctor with regards to the way they perceive it. The labeling is very clear. And this is something the OB/GYN, which is our first target, have been -- have used to do, is just to make sure that they assess the pregnancy status of the patient, and this can be done with simple criteria like CDC guidance, for example, which is a series of questions about timing of the periods, about the sexual activities, about use of contraceptives. And with a test of pregnancy when necessary, really if there is any doubt. And this criteria, the CDC criteria of asking question to the patients actually have almost 100% ability to predict and to rule out eventually pregnancy. So we don't expect it overall, this contraindication will have any significant impact on our forecast. And in fact, we focus really on the important attributes highlighted in the labeling but really, we really are the things that are critical for doctors are critical for patients. And based on this criteria, we expect to achieve the forecast that we have been mentioned in the past. The $400 million to $600 million of -- at peak sales.

Okay. And if I could just follow-up on that. I think it seems pretty clear to me, I think the labels [ as a ] 4-day window is a onetime or acute treatment. So I don't think it'd be perceive a huge risk. But does this have any impact on the RVVC indication, if we're talking about longer 6-month treatment in theory, the window for pregnancy grows in that case. So I'm just wondering if that conversation has come up with regards to conduct of that trial, has it impacted that trial with regards to screen failures or dropouts. If you could just give us any color there.

Well, actually, at this point, we are still conducting the CANDLE study. I think it's a little bit premature for us to see what could be the potential impact but again, as you just mentioned, that this is a very short period in which, for example, with the individual treatment with a current labeling, patients should have a contraception. So we -- let's say that right now, it's a little bit too early. Let's see when we have the data, and we will have a further discussion with the agency.

Our next question comes from the line of Steve Brozak with WBB Securities.

Congratulations again. I just have 2. Number one, with not as much experience as you have in drug approval and marketing, I've seen 2 types of drugs one, that has to be pulled through the market. And the other one that is just pushed by patient advocacy clinician advocacy. How would you characterize the BREXAFEMME in terms of that -- what kind of feedback have you gotten with from your partners and the clinicians? And I've got one follow-up after that.

Well, let's just say that one thing I learned in all these years in developing drugs. And as you know, it's more than 30 years is that you can see how the drug will be accepted by the market just by seeing how fast you can get your Phase III done. As you know, that we -- when we started the Phase III, the VANISH studies, we were expecting a 12 to 15 months to complete enrollment. It took less than half of that. And that is really because there is an eagerness, an eagerness by doctors and by patients to try something new. I think that is also has been the mainstay of treatment, either as a topical treatment or as with fluconazole. And I think there is a desire by all the KOLs we talked with to or the patients we talk to. I think patients -- unfortunately, patients -- there are patients who are obviously be coming with a problem. And fluconazole clearly doesn't address their problem. So I think that is a good omen for the interaction. And maybe we can have Christine also giving her view. I think it's some of the excitement for her to join SCYNEXIS is really because she really see the opportunity to bring a product which is really needed by patients and doctors. Christine, can you share some of your thoughts?

Yes. I mean -- thank you so much. I do agree with all of that. There's definitely a need out in the marketplace from all the research we've done. And like I said earlier, the challenge here will be for us to be very clear in our communications on the features and benefits of BREXAFEMME with our physicians because there are multiple, multiple factors with the patients out there currently. So it will be a function of us communicating to the physicians in a clear way. And that's why coming back to why we partnered with Amplity Health. They're very, very good in this situation, launches, small companies and where there are unmet needs. So really excited for June 29 to talk a little bit more about this. So thank you for the question. Hope that's helpful.

Yes. No, that's very helpful. And the last one dovetails into it. The continuum of clinicians is kind of interesting because you obviously have women that have been significantly affected with sometimes significant comorbidities and other issues. Can you tell me what the reception has been throughout the clinician continuum, for instance, the OB/GYNS in some cases, the infectious disease docs. How have you seen the reception between these -- within the clinical community? And I'll hop back into the queue after that.

Yes. Marco, I will go ahead and you can jump in.

And maybe -- yes. You go ahead, Christine.

I was going to say what I saw from the research, Marco, is there's definitely value there's perceived value for BREXAFEMME with all of these disciplines. So whether it's the OB/GYNS to primary care to nurse practitioners or PAs. There's definitely value in what BREXAFEMME can bring them. Again, kind of coming back to us making sure we are clear on those features and benefits because you have to be clear for on those pieces because each physician is dealing with not only different patients, but different practic graphics in their own practice. So again, happy to discuss this more on June 29. But I can leave you with the research definitely says that there's value built up from a perception standpoint in all of those physician offices. Thank you, Marco.

[Operator Instructions] Our next question comes from the line of Cosme Ordonez with National Securities.

Well, first of all, congratulations, a great achievement for the entire team. My question is with regard to potential approvals in other jurisdictions now that you got the FDA's approval. Marco, if you please could provide some guidance in what are the next steps to get the drug approved in other jurisdictions especially in Europe, where price of antifungals are highly competitive, even in line with the U.S. pricing? And a question for Eric. With regard to the company's loans and partnerships, what milestones could be triggered with these approvals? And if you could provide an overview of the financial position of the company, that would be great?

Okay. Thank you for the question. Let me start with the first one, talking about the partnership clearly, as we announced recently, our partnership with Hansoh. And with Hansoh, a company -- we were able to do a deal with this company, which is one of the top 5 biotech company, public biotech company in China. And of course, as you can imagine, they are working now feverishly and includes collaboration with us to prepare for higher various filings in the China territories. With regards to Europe, stay tuned. Just suffice to say that all our programs, with VVC, both the VANISH and the CANDLE studies were all discussed and agreed with the European Medical Agency. So they were considered a design in a proper way to be to be approvable in Europe. So stay tuned, we will talk more in the future about our efforts for a partnership in Europe. With regards to the -- our financing situation simply as we -- as we mentioned, that is, we have more than -- right now, $100 million in cash and cash equivalents. We have additional access to cash. Like, for example, the -- as you may know, there is a second tranche from the loan facility that we implemented recently. There are also milestones. Milestones, for example form a partnership with Hansoh. They as you -- as we mentioned, that is, we have more than $100 million in potential milestones in the future, plus double-digit royalties. So we believe that we have a combination of sources in terms of -- to continue to strengthen our cash situation, also with -- in non-dilutive way. And, of course, to continue to rely on the fact that we expect actually to start to sell the product. So we -- that is actually where we are focusing a lot of our attention right now is to make sure we have a great launch, so we can achieve in the future -- the type of sales that will support -- self support the company. So thank you, Cosme.

Our next question comes from the line of Kumar Raja with Brookline Capital Markets.

Congratulations once again. First, with regard to the post-menstrual period with females. Can you talk a little bit about the unmet need there and the market opportunity? And also with regard to the launch, where do we stand in terms of manufacturing and drug supply.

Well, with post-menstrual, it means also that clearly, the agency realizes that this product and this is the way our study was designed is to test the product also in patients, in younger patients, younger than 18. But we've after post -- after having the starting that period. So our labeling basically which actually -- post-period happens at around the age of 12. So we don't expect this to be a large part of the market. But it just provides the opportunity to doctors to treat the cases of pediatric patients with -- post-menstrual pediatric patients who can benefit from our drug. So it just provides an opportunity. The big chunk of patients, the largest number of patients are actually between 20 and 45 is really where most of the cases are. But this is a labeling that allows again to treat this type of cases. And what was the second -- your second question, sorry?

Yes. Just where are you guys in terms of manufacturing and drug supply for the launch?

Manufacturing. Actually, we have supplies at hand ready for -- to support the launch. I would like always to remind people that SCYNEXIS at its DNA and its creation was a manufacturing company. So I think that we know how to manufacture drugs. And now we transferred our manufacturing to companies with of course, at commercial capabilities in terms of size. As you know, it is the fact that we went through also a first pass approval shows that our CMC and our manufacturing situation was of complete satisfaction to the agency. So at this point, we are ready with adequate supplies to support in the future our launches, and we continue to produce our product as we need. So very -- in a very, very good position.

Ladies and gentlemen, this concludes our question-and-answer session. I'll turn the floor back to Dr. Taglietti for any final comments.

Thank you, operator, and thank you all again for joining us here this morning. The BREXAFEMME approval is the culmination of several years of hard work from our team who remains committed to innovation and advancing the entire portfolio of ibrexafungerp development programs to create a drug with broad utilization that can help patients across a spectrum of fungal infections. We would like also to thank our investigator, patients, partners, shareholders, investors, who are aligned with our vision and that have supported us to this point. Thank you all. Thank you.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.