SCYNEXIS, Inc. Q4 FY2021 earnings call

• R&D: Obtained approval of ibrexafungerp for VVC, plan to expand labeling to recurrent VVC by end of 2022, MARIO trial for invasive candidiasis with potential approval in 2024.
• Launch: BREXAFEMME had 4,600 prescriptions and $1.1M net revenues in 2021, covered by commercial insurance for over 40% of lives in US.
• Corporate: Closed 2021 with over $100M cash, runway into Q2 2023, partnership with Hansoh for Greater China.

For the fourth quarter of 2021, BREXAFEMME generated $600,000 in net revenues with a cost of product revenue of $200,000. For the full year 2021, BREXAFEMME had net product revenue of $1.1 million and a cost of product revenue of $300,000. BREXAFEMME was covered by commercial insurance for more than 40% of lives in the U.S. and achieved about 4,600 prescriptions and $1.1 million in net revenues in 2021.

• Plan to expand BREXAFEMME labeling to recurrent VVC by end 2022.
• Expect ibrexafungerp approval for invasive candidiasis in 2024.
• Cash balance of over $100M with runway into Q2 2023.

• Risks associated with forward-looking statements, actual results may differ from expectations.
• Impact of COVID-19 on sales and access to healthcare providers.
• Dependence on successful commercialization of BREXAFEMME and R&D programs.

Q: 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.

A: 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.

Q: 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.

A: 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? Christine: 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. Marco: 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. Christine: 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.

Q: 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.

A: 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.

Q: 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?

A: 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.

Q: 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?

A: 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.

Q: 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.

A: 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.