SCYNEXIS, Inc. (SCYX) Q4 2021 Earnings Report, Transcript and Summary

Greetings, and welcome to the SCYNEXIS, Inc. Fourth Quarter and Full Year 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Debbie Etchison, Executive Director of Communications and Investor Relations. Please go ahead.

Hello everyone, and welcome to today's conference call to discuss our fourth quarter and full year 2021 financial results and corporate update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future, leadership's expectations for our future financial and operational performance, as well as our business strategy. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Please refer to our filings with Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, and quarterly report on Form 10-Q, included in each case under the caption, Risk Factors, and in other documents subsequently filed or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, March 29, 2022. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made. The information on today's call is not intended for promotional purposes, and not sufficient for prescribing decisions. Joining us on today's call are SCYNEXIS President and CEO, Dr. Marco Taglietti; Chief Commercial Officer, Christine Coyne; Chief Medical Officer, Dr. David Angulo; and Interim Chief Financial Officer, Larry Hoffman. Following our prepared remarks, we'll open the call to questions. Now, I will turn the call over to Dr. Marco Taglietti, President and CEO.

Thank you, Debbie. Good morning, everyone, bonjourno a tutti. Thank you for joining us today for our fourth quarter and full year 2021 earnings investor call. We are excited to share with you updates on the progress of the launch of BREXAFEMME and outline our vision for the future of the ibrexafungerp franchise. But as we get ready for 2022, a pivotal year for SCYNEXIS, let me briefly summarize key accomplishments of 2021. On the R&D front, we obtain approval of ibrexafungerp for the treatment of VVC, the first new antifungal class in over 20 years. Following the positive Phase 3 result of the CANDLE study announced in February, we plan to expand by end of the year the labeling of BREXAFEMME to include the prevention of recurrent VVC. And as a result of our agreements with FDA, we are expanding the hospital program with the MARIO trial that may allow us an approval in invasive candidiasis in 2024. With launch of BREXAFEMME, SCYNEXIS had a historic transformation in 2021, becoming a fully integrated company. At the end of 2021, BREXAFEMME was covered by commercial insurance for more than 40% of lives in the U.S. And we achieved about 4,600 prescriptions and $1.1 million in net revenues. On the corporate side, we close 2021 with more than $100 million in cash and the runway into the second quarter of 2023. We also continue to look for business development deals like the one with did with Hansoh for Greater China and for other non-dilutive ways to strengthen our cash balance. But the most important point to bring home today is that our vision to make ibrexafungerp is successful, sustainable, and profitable antifungal franchise is becoming reality. With BREXAFEMME now approved the launch for the treatment of VVC, also known as vaginal yeast infections, we plan to expand its labeling by end of this year to increase the prevention of recurrent VVC, an indication for which nothing is yet approved. Moreover, we expect to get ibrexafungerp approved for terinfections, namely invasive candidiasis in 2024. All these indications when taken together will create a franchise with the potential to generate $700 million to $800 million a year in net sales in the U.S. alone. So what are our key goals for or 2022? Well, one is expanding BREXAFEMME labeling and advancing the hospital program. And these are key objectives for our earnings team. David will talk more about these programs. The team will discuss how we plan to grow BREXAFEMME adoption, and how to expand insurance coverage. Larry, our Interim Chief Financial Officer, will provide more details on our expenses and cash balance. And then, we will open the floor for a Q&A session. Now, I would like to turn the call over to our Chief Commercial Officer, Christine Coyne, Christine?

Thank you, Marco and good morning. Last quarter, I shared with few our prescribers enthusiasm about BREXAFEMME. As you may recall, we reviewed our plans to target clinicians who treat a great deal of vaginal yeast infections. Since our early days of launch in August, we encountered exactly what we expected, a well ingrained physician habit to continue using the same old azole products. Yet following a discussion with our representatives, healthcare providers confirmed a desire to treat patients with vaginal yeast infections with a new product beyond the commonly used azole. And so our plan to ensure awareness and understanding of BREXAFEMME as a new improved tool, secure vaginal yeast infection remains our number one focus each day. BREXAFEMME is the first and only oral fungicidal therapy that treats vaginal yeast infections providing symptom relief with complete resolution. It has activity against a broad range of Candida species, including those that are resistant to fluconazole. These key clinical benefits coupled with the ease of a one day oral dosing are of great importance to healthcare providers and continue to motivate prescribing. In August, our sales team began to meet with their key healthcare provider customers. As you may recall, there is a wide and deep swap of OB-GYNs and other physicians who treat women with VVC. And our focus is on the top VVC prescribers. Our sales team work to generate awareness of BREXAFEMME, while at the same time helping physicians clearly understand the utility of a non-azole fungicidal treatment for vaginal yeast infections. Based on their work, we have built a strong early base of BREXAFEMME prescribers. Our intention is to grow that base of prescribers and continue to expand prescribing. In quarter 4, 2021 alone, more than 1,600 physicians prescribed BREXAFEMME. This progress is positive and these are the early indicators of BREXAFEMME adoption. Now, let's discuss the early results of our marketing and sales effort. First and foremost, it is important for me to convey to you that BREXAFEMME has been received positively by our healthcare provider customers. We have been able to educate prescribers on the benefits of BREXAFEMME. As with all launches, convincing decision makers to do something different after a two decade habit is quite a task. We have been able to effectively begin the conversation with these prescribers and help them to identify appropriate patients and to trial BREXAFEMME. We generated 3,674 prescriptions in quarter 4, 2021, which represents solid growth over quarter 3, 2021. The majority of the growth in Q4 came from what I discussed earlier, which is expanding our prescriber base and generating more trial of BREXAFEMME with new writers. In November, we administered what is called an Attitude Trial and Usage report, or ATU. We learned that the same prescribers are reporting that they expect to expand their usage of BREXAFEMME over the next three months. What is important here is that our message BREXAFEMME is an effective one day treatment that kills yeast is both meaningful and motivating to them. And now these prescribers are having good outcomes with their patients and they are expanding their use. These are all good indicators. Now, as for quarter 1, 2022, our field teams continue calling on their healthcare providers, where they are able, given some office closures due to COVID. In some instances we have had to pivot like other companies to call on healthcare providers who are more accessible. The inability to get into some of these offices accounted for softness in January. However, as things began opening back up in February, you can see our ability to access these physicians and continue to drive their use of BREXAFEMME once again. As we continue to build demand for BREXAFEMME, we also continue our work with insurers and payers. As I've mentioned in our last call, our national account directors are very seasoned and tenured with long relationships with their payer customers. Based on this, they have been able to secure important BREXAFEMME review meetings since early 2021. By the end of quarter 4, 2021, we successfully garnered coverage of an access to BREXAFEMME for more than 81 million commercially insured lives, which represents more than 48% of commercial lives. This is not just a testament to the efforts of our national account team, but to the payers recognizing the high unmet need and clinical value of the first non-azole therapy to treat Candida. This coverage is not easily secured. And I am pleased that we are tracking ahead of our expectations at this time. Our launch to date has been highly focused on generating awareness, trial and usage with our healthcare provider customers, while gaining access to BREXAFEMME with payers. It is working. As we all know well launches our critical phase of a product's commercial life cycle and that's without a pandemic. I am pleased with the efforts of our field teams, despite difficult external stress factors in the environment. They have endured the challenges of the pandemic, both personally and professionally, and they soldiered on and remain motivated and enthusiastic to keep that -- keep growing the brand. It is rewarding to bring such an important therapy as BREXAFEMME to healthcare providers and to patients. The feedback from physicians has been highly encouraging and hearing their experience with BREXAFEMME continues to fuel our efforts. Thank you. And I will now turn the call over to Dr. David Angulo, our Chief Medical Officer. David?

Thank you, Christine. We continue to make significant progress in the development of ibrexafungerp for both community and hospital settings. As recently announced, we successfully completed our pivotal Phase 3 study CANDLE and reported positive results. This study evaluated the efficacy of ibrexafungerp in preventing recurrences of Vulvovaginal Candidiasis in patients with recurrent VVC. Ibrexafungerp was given 300 milligrams BID one day a month for six months, and what's compare against matching placebo. In the study, 65.4% of patients received ibrexafungerp achieved clinical success, which was defined as not having any recurrence at all, either culture-proven, presumed or suspected, through the week 24 compared to 53.1% of placebo treated patients. This difference was statistically significant. The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remain statistically significant. With these results, we are now on target for submission of a supplemental NDA in the United States in the second quarter of this year and we anticipate receiving approval by the end of the year. These results reinforce the broad clinical utility of our novel antifungal in VVC and position ibrexafungerp as a much needed treatment option for patients suffering from recurrent VVC. Additionally, the CANDLE study provided some exciting news on the activity of the one day ibrexafungerp treatment in patients who failed three days of fluconazole therapy. More than 70% of these fluconazole failure patients successfully achieved a significant reduction or elimination of signs and symptoms after the one day course of ibrexafungerp. We also continue making progress in our development programs for invasive fungal diseases. And the following is a brief summary of the status of each. The initiation of activities for our MARIO study, evaluating oral ibrexafungerp as a step down therapy in patients with invasive candidiasis are on track for having the first patient enrolled in Q2. The innovative design of this study has triggered significant interest from investigators, and we are currently evaluating a large pool of potential size globally. We will be enrolling approximately 220 subjects, and we anticipate completion of this study in early 2024, with potential approval late that year. The significance of the unmet medical meeting invasive candidiasis and the potential for ibrexafungerp to offer a clinical benefit in this indication is highlighted by the Orphan Drug Designation that ibrexafungerp receiving the past year from the European Medicines Agency. The same designation was previously granted by the U.S. FDA. We continue to enroll well in our FURI and CANDLE study and CARES study. As you may recall, these studies focused on patients with severe fungal infections, including candidiasis. That our refractory to antifungal agents or in patients that cannot tolerate refractory to antifungal. We will be sharing the latest interim look at our data for these studies in Q2. Previous analysis of interim data from these studies have clearly indicated the significant potential of ibrexafungerp as a salvage therapy option for it, very difficult to treat severe fungal infections. Our SCYNERGIA Phase 2 study evaluating ibrexafungerp in combination with voriconazole for the treatment of invasive pulmonary aspergillosis remains active. Also enrollment was impacted by the COVID pandemic, we remain confident that enrollment will improve this year, allowing us to reach meaningful conclusions by year-end. The results from this study will guide decisions regarding potential next steps for development of ibrexafungerp for the treatment of invasive pulmonary aspergillosis. In Q4, the intravenous formulation of ibrexafungerp successfully completed single and multiple ascending doses in our Phase 1 study. We were very pleased to see that the liposomal formulation of ibrexafungerp was well tolerated and the target exposure was reached. While we discussed the next steps of our IV development program with regulators, we are scaling up manufacturing to enable subsequent clinical phases of development. And as previously mentioned, we have completed our registration trial for the recurrent VVC indication, and we are on track to file next quarter. And approval of the recurrent VVC indication will result in a very broad VVC label, with the opportunity to help patients across a broader spectrum of the disease, including those suffering from incidental VVC episodes, to those who recurrent VVC that are often seen their lives significantly affected by this chronic condition. I also want to mention that last year, we had a significant preclinical discovery. When we reported that ibrexafungerp showed activity and synergistic efficacy with amphotericin B in a mouse model of mucormycosis. Alternative treatment options for this devastating disease with very high mortality rates as this are desperately needed and this early, but significant development guide us towards evaluating the potential clinical activity of ibrexafungerp in this condition, which we are aiming to do within our FURI study. And now let me turn the call over to Larry Hoffman, our Interim Chief Financial Officer.

Thank you, David. For the fourth quarter of 2021 BREXAFEMME generated $600,000 in net revenues, was the first full quarter of sales for BREXAFEMME since its approval by the FDA in June of 2021. As a reminder, we are recording revenue upon the sale of inventory to the wholesaler. The net revenue amount represents sales. None of all discounts to insurers. Also includes any discounts from patient assistance programs like our co-pay card. We expect our net selling price to improve over the course of the year. Our cost of product revenue was $200,000 for the fourth quarter of 2021. R&D expense for the fourth quarter of 2021 decreased to $7.7 million from $10.2 million versus the comparable prior year quarter. SG&A expense for the fourth quarter of 2021 increased to $15 million from $5.2 million versus the fourth quarter of 2020. The increase of $9.8 million was driven by a $7.2 million increase in commercial expenses relating to the ongoing commercialization of BREXAFEMME. Total other expense was $6.9 million for the fourth quarter of 2021 versus total other expense of $27.4 million for the fourth quarter of 2020. During the fourth quarters of 2021 and 2020, SCYNEXIS recognized non-cash losses of $5 million and $21.3 million, respectively on the fair value adjustment of warrant liabilities and net cash losses of $600,000 and $4.4 million, respectively on the fair value adjustment of the derivative liabilities. The net loss for the fourth quarter of 2021 was $29.2 million or $1.05 a share compared to a net loss of $42.7 million or $3.43 per share for the comparable prior year quarter. Our full year 2021 financial results are as follows: BREXAFEMME generated net product revenue of $1.1 million for 2021. And earlier in 2021, we recognized $12.1 million in licensing revenue from Hansoh Pharma pursuant to our exclusive license agreement for ibrexafungerp in the Greater China region. Our cost of product revenue was $300,000 for 2021. R&D expense for 2021 decreased to $23.8 million from $36.5 million versus the comparable prior year. The decrease of $12.7 million or 34.9% was primarily driven by decreases of $5.5 million in CMC costs, $5.2 million in clinical development expense, $900,000 in preclinical expense, $500,000 in regulatory and $500,000 in other R&D related programs. SG&A expense for 2021 increased to $49.9 million from $14.6 million versus the comparable prior period. The increase was driven by increases in commercial expense to support the ongoing commercialization of BREXAFEMME as well as business development expense associated with the licensing agreement with Hansoh, which we entered into in February of 2021. Total other income was $24.9 million for 2021 versus total other expense of $7.2 million for the comparable prior year. During 2021 and 2020, SCYNEXIS recognized a non-cash gain of $30.4 million and a non-cash loss of $5.2 million, respectively on the fair value adjustment of its warrant liabilities and non-cash gains of $1.2 million and $2.3 million, respectively on the fair value adjustment of its derivative liabilities. The net loss for 2021 was $32.9 million or $1.25 per share compared to a net loss of $55.2 million or $5.15 per share for the comparable prior year. As Marco mentioned at the start of the call we have a strong cash runway into the second quarter of 2023. We have cash and cash equivalence of $104.5 million as of December 31, 2021, with an additional $9.7 million raised in Q1 of 2022 from the sale of New Jersey net operating losses for $4.7 million and the draw down of $5 million from the Hercules SPV debt facility. Our partnership with Hansoh provides us with the potential of $112 million in future long-term development and commercial milestones, and the strength of our patent protection and our ongoing business development efforts provides us with additional opportunities internationally. I thank you. And before we begin the Q&A, I will turn the call back over to Marco.

Thank you, Larry. And before we close the call for Q&A, I want to iterate a few key points. First, BREXAFEMME is an innovative product for the treatment of VVC and we are making great strides with HCPs and patients. Moreover, we anticipate expanding the labeling to include prevention of recurrent VVC by end of this year. Second, our R&D pipeline for hospital indication is extremely robust, and we expect to enroll the first patients in our MARIO trial in the second quarter. The objective of the MARIO trial is to obtain the indication of invasive candidiasis for ibrexafungerp. And third, we are in a very strong financial position with a cash balance of over $100 million and runway into the second quarter of 2023. Operator, please open the floor for questions.

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question today is from Louise Chen of Cantor. Please proceed with your question.

Hi. Good morning everyone. This is Carvey on for Louise. Thank you for taking out questions. So, you pointed that you're at 40% of commercial insurance life. We're interested in hearing more of the strategy increasing the coverage. Also what is your goal in coverage by the end of this year? Second question is also on commercial. Appears, the number of scripts per healthcare provider is more than 2.3 scripts for each HCP on average for Q4. We took the 3,700 divide by 1,600. How does this compare to other antifungal treatment in the start of the product life cycle? What would be the typical rate in VVC? And how do you expect the script activity to improve over time? Thank you so much again.

Well, that's a lot of questions. So, let's start with the coverage first. I mean, first of all, we are very pleased with what we achieved. And certainly, Christine and her team continue to work hard to expand it. Christine, any comments on our strategy to continue to get the more coverage?

Well, I mean, we'll continue doing what we've done. We have had a lot of success there, Marco, as you know. The national account guys know their customers well. They work with the medical science liaisons to bring the clinical data to the payers. The payers themselves have seen the need for another option, a non-azole option and so that right there has been really important to our payers. So, we'll continue doing all the things we have been doing, which is have these pharmacy and therapeutic committee review meetings. We'll continue going through the clinical data. And even Marco, some of these payers themselves are looking at their own claims data to see what's happening in their patient membership when they don't have an option to azole. And so, that's become a very important thing for us because the payers need something else when azole doesn't work. So, I hope that helps.

And with regard to the second question, this is -- Christine can further elaborate, but I would like just to remind that there is very little previous experience, because the last time that something was approved in VVC was more than 25 years ago. So, there is maybe not too much we can compare to. And so, we are certainly entering a field where we need to break some habits, as Christine was mentioning. Christine, please.

Yeah. Absolutely. And it takes time, right? In any category -- I've done this in multiple different categories -- you have to make your calls to the physicians that matter, the physicians who are treating these conditions. And in this case, these VVC treated. But you can't just do it once. You have to do it multiple times. It takes multiple times to change a habit, explain and remind them what BREXAFEMME is. So, looking at the rate of 2.6, 2.7 at this moment in time, 2.6, 2.7 TRx per prescriber at this moment in time, that's pretty good because that means to me -- what I'm seeing is that we've convincingly stated that BREXAFEMME is a treatment for these prescribers. It's a new tool and they started to try it. That's what the trial is. And then they found other patients. I mean, they continue to find other patients. So, it is straight math, but it is a rate we will look at. How many patients, have many prescriptions per prescriber as we go, but it's super early, Marco, but that's a pretty good rate.

Thank you. Next question.

Thank you so much. Congrats on the quarter.

Of course. Thank you.

The next question is from Michael Higgins of Ladenburg Thalmann. Please proceed with your question.

Thanks. Congrats guys on the successes in 2021, really a transformational year for you guys. Just a couple of questions on the marketing approaches. You touched upon some of these in your comments and your Q&A so far as well. But any potential changes to the marketing strategy? And the back half of the question is, when you take a look at the prescribers in the back half of 2021, it seems to be that there were some early adopters. Is that who you were targeting? Is that maybe just some folks who understood and the product maybe had some patient interaction that got them going. I'm just trying to get a sense for that. As we saw over the winter months, there seem to be sort of a plateau. So, I believe Omicron had some impact there as well. So, just trying to get a sense for the efficiency of the targeting so far. Thanks.

Yeah. Hi, Michael. It's Christine. Thank you for the question. Yeah. I mean, you always want to take a look at your targeting, right? But -- and we have looked at it. The targeting is really, really strong. It definitely -- you use a good phrase, early adopters. That was part of the criteria that we looked at for these call targets, right? And it absolutely was right. So, you get to trial on adoption quicker with those types of targets. So, for sure. In the January timeframe, yeah, absolutely. Some of those offices were closed and those are the most productive offices. So, you definitely see some softening there, but it absolutely tracks with when those offices start to open and our reps are able to get back in, you absolutely see the bounce back there. So, no change in the approach, except to say, always make sure we hit our high death aisle, call targets because they matter, and that's exactly who we have with us in that strong base. And they're continuing to expand their own prescribing, because they are having good outcomes. So, you always want to make sure you stick with your base of these types of call targets, early adopters. Does that make sense, Michael?

Yeah. That makes a lot of sense.

And Michael, if I can add talking about strategy, actually when something that Christine was mentioning before, something that clearly has been very, very important as we were expecting for doctors is one of the attributes of BREXAFEMME fungicidal activity. The fact that is really a different class resource [ph] and that really brings an attribute that is never been unfortunately in their moratorium for VVC. So, that is clearly was confirmed by the feedback we get from the field. So, we think we are on the right strategy, and we will continue to pursue it.

Thanks Marco. I appreciate that. One follow-up for you, Marco. How are discussions going with potentially European partners? What stage would you say your outreach and discussions are at this stage? Thanks.

As I think I've been mentioning recently, after the approval last year. And so, right now, we have a product that has been derisked [ph] in terms of regulatory -- from a regulatory aspect. Clearly, the type of conversation and interaction that we had in different regions has been intensified. There are three major reasons that for us are critical. One is Europe, one is Japan and the other is Latin America. So, these are three major reasons. And, of course, discussions are ongoing. So, just stay tuned. Clearly, the fact that we were able last year to have a partnership with -- for Greater China with a company like Hansoh with a very favorable deal, that means that there is clearly a perception that this product has significant value also upside of the way. So stay tuned. We -- I can assure you that we are working hard on this aspect of business development.

Appreciate it. Thanks guys.

Thank you. Thank you, Michael.

[Operator Instructions] Our next question is from Oren Livnat of H.C. Wainwright. Please proceed with your question.

Thanks guys. I have a couple. If I could just maybe follow-up on the first question. I was that was talking about prescriptions per writer. To dig further that, 2.5 per doc is an average, obviously. Are you seeing practices or several practices where they're writing a much higher volume and maybe for a meaningful percentage of their VVC patients already? And if so, what factors are driving that? Is it just a matter of experience? Or is it more about access in their particular region or patient base, or something else? And how are you leveraging that as you're seeing it? Or how do you leverage that across other targets, maybe speaker programs, et cetera? And I have a couple of follow-ups. Thanks.

Thank you, Oren. It's Christine. Thank you for the question. Yeah. It's a bunch of all of that stuff. So, we absolutely have prescribers that are writing well above the 2.5 TRx per prescriber. That -- like we said, that was straight math. You absolutely do have higher rates there. It comes -- it's the criteria, I would say, our physicians we got to really early, they already had some information and knowledge from the medical side, publications, all of that going into our launch in August. And then, I would say, the integrally promotion works, right? So, when our reps show up and they show up consistently and they may convincing arguments that BREXAFEMME is a new tool that you should use for that patient, it always -- you see that -- Oren, you see that you apply that promotion, and it actually comes back in a very reciprocal way from utilization on prescribers part. So, it's a confluence of a lot of those things. I don't know what each and every prescribers denominator of their VVC patient load are, but we absolutely have prescribers that are writing above the 2.5. And the idea there, to your point, is to share best practices. So, whatever is working, if it's the promotion or if it's seeing a certain senior type of a doctor and talking to them in a certain way, we share that across the whole of the Salesforce in what's called best practice sharing. And then to your point, there are other tactics like speaker programs. We will bring some of that information in and show how a speaker will get up there and talk about what they see and how they see BREXAFEMME working in their patient population. So, it is a bunch of factors, Oren.

Okay. And just who are the patients do you think that are getting BREXAFEMME in the stage of the launch? I mean, obviously, it's not yet approved formally for prevention of recurrent VVC. But should I assume that it's being used mostly in refractory or repeat customers, so to speak? Or are we already seeing -- to the best of your understanding, first line or de novo patients getting it?

Well, as you can imagine that as we -- sort of low-hanging fruit for our -- at the beginning of the launch are those patients that have been experiencing in the past VVC, and maybe they're not yet been fully satisfied with fluconazole and with the fungistatic effect. So, these are the type of patients that certainly we may have more traction at the beginning, because of the one where can really benefit of something different of a new mechanism of action and the fungicidal mechanism action.

I would actually -- you said it well there, Marco. We really stick with -- what makes sense to the doctors when we talk about is the fact that this is a non-azole, it's different. Fungicidal activity, it kills, right? One day dosing. And the last piece, Oren, that really gets traction when we're talking to doctors is complete resolution of signs and symptoms. And that's almost like a patient type message, right? And so, when you put these pieces together and you talk to the doctors, they actually think about the patients they're treating and they come up with it. So, it's not necessarily -- I know we as commercial people think about as a first, second, third line. We actually paint the patient picture, Marco, and that's really where we get the traction. Does that help, Oren?

Sure. And just if I could be greedy, I apologize. Just lastly, I think on the 3Q call, you talked about maybe rolling out some "DTC", which mean a lot of different things, obviously. In early 2022, I'm wondering if that has happened or is happening.

Yeah. So, we are definitely so funny DTC. So, I would change it to DTP as inpatients, right? So, what we will do is, we have a really nice program campaign that we will launch in the summer timeframe, coordinate it with our summer kick-off of the POA, the South POA. And it will have some really strong and memorable campaign and messages for these patients that we're learning about every single day. And it will be in the doctor's offices, Oren. So, there's televisions in doctors' offices. There's behind material. We'll put content up everywhere there, as well as we will do a really strong digital push banner ad, content integration, stuff like that. So, that will be summer timeframe. You didn't miss it.

Okay. Thank you.

Thank you, Oren.

The next question comes from Steve Brozak of WBB. Please proceed with your question.

Good morning. Sorry. I wasn't sure if I was on mute. Look, we very much appreciate the importance of the drug, and that's what I'd like to focus on. Have you gotten any direct feedback from the clinicians as to patients who have been these refractory women who have literally experienced a complete change in terms of their signs and symptoms? And how do you incorporate that into future messaging? And what would you expect going forward on these types -- this type of feedback? And I've got a follow-up after that, please. Thank you.

Thank you, Steve, for the question. So, let me make, first of all, something very clear with this. Recurrent VVC or patients who are defined as recurrent VVC is not an approved indication. Therefore, we neither promote and support of the commercialization in this indication. What we expect, based on our Phase 3 trial, is actually to file a supplemental NDA this coming quarter and getting an approval. Then, we will be in a position really to go out and to promote the indication. On the other hand, of course, we -- what we have seen some interesting results in our CANDLE study. As David was mentioning, there has been some patients who received three doses of fluconazole and these are patients that were part of the study and therefore they met the definition of recurrent VVC. They received three doses of fluconazole, which is three times the approved dose actually, and still their VVC was not resolved. And so, they entered in this open-label study where they were getting one day treatment with BREXAFEMME, and the results were very, very promising. More than 70% of them actually had a significant improvement or cleared their symptoms. So, we really feel that these are important data. And probably, you may expect that probably some of the doctors out there when we are treating patients who may have experienced multiple episodes in their lifetime, they may see the same benefit.

Okay. And let me swap over to, because obviously, this is one of those items where the science can drive this and the results can drive this. On the Gomal [ph] paper that came out a couple of weeks ago, when he was reporting about the strength of ibrexa, especially activity around Candida glabrata. Would you expect that as clinicians, especially those who are on the leading edge to start to see the advantages? Would you expect more of these types of publications, more of these types of commentaries talking about the critical importance of this next-generation product? And I'll hope back in the queue. Thank you.

Thank you, Steve. This is David. Thank you for the question. Yes. Certainly, one of the key attributes of ibrexafungerp is really the activity against the non-albicans Candida issues, including Candida glabrata. And we know that one of the cases that are not responding to the [indiscernible] may be because the species is not susceptible to the azole. And Candida glabrata is one of the ones who often have very high levels of non-susceptibility against azole. So, we do expect that more and more information is going to come as we expand the use of ibrexafungerp in these patients about the response rates, particularly in non-albicans Candida issues. And so, that is one of the key attributes that we found that was fascinating for this product in VVC because also -- through fluconazole may work toward the most, let's say, majority of Candida albicans, you really need to drill down to know if this infection is caused by Candida albicans. When the majority in the common setting, they don't even know what the infection is caused by. So, they don't even know the species. Having a drug like ibrexafungerp that really has good recent activity over Candida albicans, glabrata, krusei, which is 100% don't respond to fluconazole, that just gives you the opportunity, the ease of mind to know what you're prescribing has the greatest chances to be successful. So, we believe that this type of publication that you mentioned are going to continue popping up. And certainly, we are investigating those features as well, but thank you for mentioning that.

And Steve, I can also add. Candida glabrata and Candida krusei are not probably important, not only in the VVC, but also for hospital infection. In fact, Steve, thank you for the question. But gives me the opportunity to remind everyone that VVC is just part of the larger franchise, a larger antifungal franchise, where we will have the VVC, the vaginal yeast infections. Treatment are recurrent, but there is the hospital too, which is a very, very important program because this is also a program where we can bring a product that can really save lives in hospital infection invasive fungal infection. So, that is actually the attractiveness of this ibrexafungerp. This ability to cover a very broad range of indications -- and of course, now a lot of the focus is on VVC because we are launching this. And, of course, that is -- I appreciate that this is very important, but -- just to remember and to remind everyone that this product has a much broader potential also beyond VVC. Thank you, Steve.

Again, thank you and obviously good luck in the prosecution of the sales. Thank you again.

Thank you. Thank you, Steve.

The next question comes from Kumar Raja of Brookline Capital Markets. Please proceed with your question.

Thanks for taking my questions and congratulations on all the progress. So, with regard to recurrent VVC, what are your plans with regard to educating physicians as you work through getting the sNDA approved? What medical meetings are you planning to present those? And do you have any plans to have other educational events for them?

Yeah. I can add on this. This is David. Thank you Kumar for the question. Certainly yes, the medical affairs team is really putting all the plans together to really support a very strong educational campaign in anticipation for an approval and launch for product for that particular indication. The team -- the medical affairs and MSL team has been extraordinarily active this past year, really attending most of the key relevant, not only national, but also regional meetings in the way that we have been able to really make connections to the people who typically drive opinions or drive the publication, so what we call the opinion leaders in that sense. But at the same time, really providing information to practices and payers, as Christine mentioned. So, this has been intensified, let's say, now in our way to really enable the launch of the approval and the launch for the recurrent VVC indication. So, you could expect that similar to what happened prior to the launch of the VVC -- acute VVC treatment that we will have CME programs and that we will have as well a very strong presence in these regular meetings that are happening in terms of the OB-GYN space, but also in the nurse practitioner space that we found is a very good source as well of potential prescribers that are eager to receive information from us. Unfortunately, I don't have in front of me right now the schedule of all these events. I apologize for that. But I can tell you that the regional meetings and the national meetings like ACO, et cetera, they are all going to be populated with our team that are really right now eager and eager to disseminate information that we have on hand for sure.

Okay.

And the publication for the VVC data in -- is going to be soon. As you could see, we have already published very extensively data in the -- coming from the acute VVC studies. We just have multiple publications around them with sub-group population. So, we have been very successful in putting all that information in the public domain and we will do as well with this data.

Okay. Thank you. And you talked a little bit about geographic expansion potentially with partners, Europe, Japan and Latin America. What kind of regulatory interactions are ongoing there? Or is that something that a potential partner will pursue?

Well, actually, as we have disclosed many times is with regards to Europe, all our programs have been always discussed with the European Medical Agency and incorporating suggestions coming from the European Medical Agency to make sure that our final package was, let's say, submission ready for European Medical Agency. And that really is the European -- the authority that we have been discussing the most.

And with regard to Japan and Latin America?

Well, that is -- as you may know that they have a very -- especially for Japan, special requirements, they need to have some bridging activities and that will be something that will be carried out by the potential partner.

Thank you so much.

Thank you. Thank you, Kumar.

The next question is from Michael Higgins of Ladenburg Thalmann. Please proceed with your question.

Thanks. A couple of follow-ups, if I could, here in the time remaining. Christine, I'll leave you alone on these. These are more so for David or Marco. Just some clinical questions. If you can give us, first off, your outlook for timing design of any IV liposomal formulation. Second question is on SCYNERGIA. Is back half of 2022 data reasonable? And then, third question being on mucormycosis, have you seen any patients enrolling in the period? Thanks guys.

Michael, this is David. Thank you for the question. So, the first one is regarding the IV formulation and timing, and just make sure that I got them all. So, we are right now …

Yeah. Sorry. Yeah. Yeah.

Yeah. Sorry, thank you, Michael. So, for the IV formulation, as I mentioned, we were extraordinarily pleased to really see that these new formulations seem to have addressed previous concerns regarding infusion tolerability issues. And now we have a formulation that we feel very confident can be really progressing the development. We are really aiming to find kind of an abbreviated bridging strategy. That's what we are trying to and that's what we are really focusing in discussing with regulatory agencies to find what is the right approach where we try to integrate this particular intravenous formulation within our development programs to maximize all the information that we obtained from these, but at the same time to really try to get them up and running in the later stages of development as soon as possible. We have not still determined what are the specific timelines for that one. But I can tell you that our objective, as I have mentioned in the past is really to progress this into Phase 2 or accelerated Phase 2, 3 very rapidly. And we are in the process of having those conversations to try to really find what is the right alternative and the right option within the regulatory environment. At the same time, we are being very optimistic that this will move forward very fast, and we are manufacturing. So, we are progressing the manufacturing for the IV formulation to enable those clinical studies as soon as we reach some level of agreement in that. But at this time, we have not guided specifically for timelines because we want to make sure that we have all the elements to be able to really plan properly and to be able to guide the timeline that you know we like to be. We typically got, for guidance we want to make sure that we can do that. So, that's where we are for the IV. For the SCYNERGIA study, your question was related if we feel confident about releasing data towards the second quarter of this year, is that right? And I must say that, that particular study, we -- in the past, we were a little bit surprised that it was somehow impacted really by the refocus or of the research units in most of the centers. This is a Phase 2 study. We need to remember that in many of the research centers that we were participating on refocused resources in doing all of the studies and we saw little activity on this study in the past few years. Having said that, that has changed and now we are much more optimistic based on the refocus and lower impact of the COVID in really the institutions that are participating in this study. We are confident that right now we're going to have a meaningful number of patients coming into the study to be able to have good conclusion. So, we have not changed our guidelines and we are still -- we're still towards that objective or we having data disclose in the second half of this year. And the third study was about mucormycosis. Mucormycosis -- so mucormycosis is a -- as you know, a very devastating condition. It has mortality rates that are typically higher than 50%. Right now, the treatment alternatives are the most commonly used is amphotericin B, but even with amphotericin B, it has a very high mortality rate. And amphotericin B has a toxicity that typically prevents that from being given for a very long period of time. So, to us, it was extraordinary -- I would say that a very nice data that we've really been able to see that ibrexafungerp with a different mechanism of action that amphotericin B seems to be acting synergistically against this fungi. And the animal model really showed a very substantial improvement in survival. If we are able to achieve even half of that in humans, it will be a tremendous advantage or a tremendous improvement in the way that this particular disease can be treated. The FURI study as is written right now enables, right now immediately, enrollment of patients with mucormycosis in a combination therapy with amphotericin B. And what we are doing is speaking with all investigators in the FURI study and making sure that they understand the data of mucormycosis that we have on hand. And we are actually presenting additional data of mucormycosis in the -- sorry if I just roll that out. But we're going to be presenting additional data in mucormycosis study, and we're making sure that investigators understand the potential value that this combination therapy may provide for that indication. So, we're very, very excited about that.

That's great. That's an awesome update. Just to follow-up on what you just said was [indiscernible] that you sort of announced that you'll have that?

We have -- as of now, in mucor we only have -- just to be clear, we only have preclinical data, but we have continued generated more preclinical data from the previous one that we announced. And we certainly were planning to announce that new data in the preclinical setting [indiscernible]. And I'm just seeing here that -- or Medical or Communications Director, David, just put that ahead of the place, in front of that.

We don't mind. Thank you.

Thank you, Michael. And operator, we are going to take one more question.

Thank you. The last question is from Oren Livnat of H.C. Wainwright. Please proceed with your question.

Since we're letting data slip, I thought I'd try to ask about CANDLE. Are we going to see more data between now or on this call maybe, with regards to efficacy? And a little better understanding how it differentiates from fluconazole. What I'm really getting at is, we saw that, obviously, top line data, which tells us a little bit. But I imagine there's a lot within that with regards to recurrence rates over that six-month follow-up. And I'm hoping you have plans to show us data on that with regards to time to recurrence and total number of recurrences over that timeframe, so we can have a better understanding and certainly, payers could have a better understanding about how game-changing ibrexafungerp versus fluconazole.

Thank you, Oren. Yes. Not on this call. Not so soon. So, I think that in the summer medical meetings is where we are planning to really have a further disclosure of additional business of information from this study. And -- but certainly, yes, we are planning. You know as we're very, very kind of like really put a lot of information in the medical meetings and really try to share with you as much as we can in a timely basis. But yes, we will -- you will be hearing about additional efficacy data. Thank you for your continued interest. And I'm guessing, it’s -- I think that it’s around the summer medical meeting timeframe.

Alright.

Okay.

Alright. Thanks.

Thank you, Oren.

There are no additional question at this -- I'll turn the call back to Marco Taglietti for closing remarks.

Yes. First of all, I would like to thank everyone. Actually, we had a lot of good questions about our products. Again, we are very optimistic and very confident on the success commercial and scientific success of ibrexafungerp. So, thank you very much for listening today and thank you for your continued support.

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