SCYNEXIS Inc (SCYX) 2022 Q2 法說會逐字稿

Ladies and gentlemen, Good morning, and welcome to the SCYNEXIS, Inc. Second Quarter 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I will now turn the conference over to Ms. Debbie Etchison, Communications and Investor Relations. Please go ahead.

Thank you. Hello, everyone, and welcome to today's conference call to discuss our second quarter 2022 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 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 the 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 another documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, August 15, 2022.

SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were 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 your questions.

Now I will turn the call over to Dr. Marco Taglietti, President and CEO.

Thank you, Debbie. Good morning, everyone. (foreign language). Thank you for joining us today for our second quarter of 2022 earnings investor call. Things are moving forward nicely here at SCYNEXIS. We are now one of the leading stand-alone anti-infective companies, a sector marked by unpredictability and utmost urgency.

We built a solid track record in drug development by achieving not only the approval of the first new class of antifungals in over 20 years, but by continuing to progress towards expanding the labeling and the use of ibrexafungerp. We launched ibrexafungerp with brand name BREXAFEMME last summer, and we are seeing a steady adoption of BREXAFEMME despite the headwinds of the macroenvironment.

Finally, we are well capitalized to execute on our goal of building a broad, long-lasting antifungal franchise, and we have a number of upcoming catalysts in 2022 and beyond.

We continue to move SCYNEXIS onward. Let me briefly summarize a few key accomplishments of the second quarter. FDA has assigned in November 30, 2022, PDUFA date for our supplemental New Drug Application to expand the labeling of BREXAFEMME to include the recurrent VVC indication. If approved for this second indication, BREXAFEMME will be the only antifungal approved for both treatment of VVC and prevention of recurrent VVC. This is a critical piece of our commercial strategy to build additional confidence with both payers and prescribers and drive increased prescription growth.

We have also started the Phase IIIb VANQUISH study of oral ibrexafungerp in VVC patients who don't respond to fluconazole treatment. The goal of this trial is to further demonstrate ibrexafungerp's efficacy in treating the most challenging VVC patients.

With regard to hospital indications, enrollment has started for the MARIO study in invasive candidiasis, with top line results expected in 2024 and the potential approval by end of 2024. Dr. David Angulo, our Chief Medical Officer, will provide you more details on these programs and the positive results to date.

Our first commercial product, BREXAFEMME, ibrexafungerp's tablet, with SCYNEXIS launched in September 2021, achieved over 5,100 prescriptions and reached the net revenues of $1.3 million in the second quarter of 2022, nearly double of what we did in the first quarter. We are excited by this progress as we work towards achieving our mission to meet the significant unmet need in women's health today and beyond. Our Chief Commercial Officer, Christine Coyne, will provide more details on our commercial plans going forward.

On the corporate side, we closed the second quarter of 2022 with more than $118 million in cash, having raised successfully $45 million in April despite the challenging times in the market, and we continue to have a solid cash runway into the first quarter of 2024.

This cash is expected to support our refreshed commercial launch in recurrent VVC in early 2023. We also have the resources to complete our hospital programs to enable additional regulatory filings in 2024. Larry Hoffman, 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. It is wonderful to be here this morning to update you on our commercial progress. As Marco stated, our commercial organization is evolving, and I am excited to share more details.

First, based on a tighter focus and sharper execution, we enjoyed significant quarter-over-quarter growth of 29% in total BREXAFEMME prescriptions in the second quarter of 2022. Key measures are trending according to our expectations, including growth in demand, new and repeat prescribers and payer coverage. We will address each of these in more detail.

As I previously stated, we are pleased, but we are not satisfied. Given all we have learned over the last year from our prescribers and our patients, we are certain that we can achieve more.

During this phase of our commercialization, we have created strategies to optimize our execution, prepare for the anticipated approval of the prevention of VVC indication and enhance HCP and patient "Say No More" campaign. These plans will set us up for continued success.

The most significant opportunity for BREXAFEMME continues to be the treatment of VVC. Additionally, with the anticipated approval of our sNDA, BREXAFEMME will be the first and the only therapy to both treat and prevent VVC and is on track to have the broadest VVC indication. We expect that a broader label will expand prescriber confidence of BREXAFEMME along with wider utility of BREXAFEMME.

Over the last several quarters, we have continually grown the number of BREXAFEMME prescribers. In quarter 2, over 2,200 HCPs prescribed BREXAFEMME, representing an increase of 25% quarter-over-quarter. Our focus is to continue broadening our repeat prescribers, while we continue to expand new prescriber use of BREXAFEMME with a broader range of patients.

BREXAFEMME prescriptions continued to grow over the last quarter. We generated over 5,100 prescriptions in the second quarter of 2022 alone, representing a solid 29% growth over the first quarter of 2022. The second quarter prescription growth was driven by more focused field execution, sharper focus on high-yield customers, more effective sales calls and accountability paired with our new HCP marketing campaign and rapid relief messaging.

In our recent HCP research audit and regional advisory boards, HCPs continue to report to us that they intend to use BREXAFEMME for their patients instead of fluconazole and other competitors. This feedback has continued to grow wave over wave as we strengthen and increase the frequency of our promotions, and we will continue to track these insights.

We remain focused on our ambition to help VVC patients who are waiting for a new solution by disrupting the decades old habit of using generic treatment and establishing BREXAFEMME as a gold standard for VVC.

By the end of the second quarter of 2022, we successfully garnered coverage of more than 109 million commercially insured lives, representing 60% of the commercial universe. We will continue to sharpen our sales execution efforts to support HCPs in prescribing BREXAFEMME for women within these plans. Payers continue to see the value of BREXAFEMME and are motivated by its differentiating benefits, especially that is fast and effective in curing VVC.

During the last call, I shared with you our "Say No More" HCP and patient campaign. The campaign debuted at the American College of Obstetricians and Gynecologists, ACOG, their annual clinical and scientific meeting in May with Premier booth presence and surround media drivers.

Our HCP awareness tactics have had an impact and increased website traffic in quarter 2. The paid search advertising of our HCP media campaign has outperformed industry benchmarks and has generated over 24,000 clicks and 709,000 impressions in a highly competitive market. This further confirms that once HCPs hear about BREXAFEMME, they are motivated to learn more about a 1-day treatment for their patients.

Targeted patient activation advertising launched in June with tactics across multiple channels, including print and digital, all driving patients to ask their HCP for BREXAFEMME. The new patient advertising has increased site traffic to brexafemme.com, and all programs have exceeded industry benchmarks. As this is our first foray into traditional patient outreach, we are delighted to see these results, but there is more we must learn to optimize our efforts here.

Recently, we conducted market research with patients to explore the topic and treatment of VVC. Here's some of the feedback we received. Excitement about having a new prescription treatment option for vaginal yeast infection, confirmation on the directness of the campaign and messaging that normalizes this topic and makes it easier to discuss vaginal yeast infection and interest in the efficacy plus the ease and simplicity of the dosing schedule.

Looking ahead to quarter 3, we are executing additional exciting new patient programs that will continue empowering women to ask their HCP for BREXAFEMME. These programs include a custom BREXAFEMME ad that will be playing during the Oprah Winfrey Super Soul podcast for 3 months. This podcast is expected to deliver 4.2 million impressions to our targeted audience in quarter 3.

We have also partnered with both national and local pharmacies and grocery stores across the country to place BREXAFEMME shelf display ads in their stores. This initiative is built to educate and empower consumers seeking information about yeast infection treatments while they are shopping for over-the-counter products.

These shelf advertisements will be placed proximal to the over-the-counter vaginal yeast infection treatments such as Monistat and will drive consumers to ask their HCP for BREXAFEMME.

We also will be rolling out a new patient video that will be placed on Hulu, YouTube and other programmatic partners as well as in targeted OB-GYN waiting room monitors. This initiative will garner over 19 million impressions and activate women to ask for HCP, if BREXAFEMME is the right treatment option for them.

These focused prescriber and patient efforts complement the groundwork of our SCYNEXIS national sales director, who we brought on in May. Who has focused on increasing the effectiveness of our sales force effort and maximizing their impact.

Over the past year, we have learned which HCPs are motivated to prescribe BREXAFEMME and where there is opportunity. Our sales team will continue to focus on these high-value HCPs. We have optimized the number of targets per rep and equipped our sales force with the necessary tools to be successful. There is a large opportunity and significant unmet need in VVC, and we've continued to grow quarter-over-quarter.

We have momentum going into the third quarter paired with a solid strategic plan. I'm delighted with the efforts of the field team and our field leaders and our national sales leader, but there is much more work ahead, and I look forward to continuing to update you on our progress.

Thank you. And I will now turn the call over to David.

Thank you, Christine. We have continued making progress towards a vision of developing ibrexafungerp for the treatment and prevention of multiple fungal infections. Earlier this year, we submitted a supplemental NDA for the indication of prevention of recurrent VVC. And as recently announced, we resigned from the FDA that our application was accepted and was granted priority review with a target regulatory decision date of November 30.

This submission was based on the positive results from our Phase III study CANDLE. As previously reported and recently presented in more detail at the Infectious Disease Society OB-GYN meeting in Boston, the CANDLE study met its primary endpoint with 65.4% of RVVC patients treated with ibrexafungerp achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected, after treatment with ibrexafungerp.

Ibrexafungerp also achieved a statistically significant superiority over placebo in key secondary endpoints, including no mycologically proven recurrence in 70.8% of patients. As the only fungicidal oral treatment for vaginal yeast infections, ibrexafungerp study is continue to demonstrate its ability to not only treat acute infections, but also prevent recurrences of the disease.

If this second indication is approved, BREXAFEMME will be the first and only product approved in the United States that is indicated for both the treatment of VVC and the prevention of recurrent VVC.

One important attribute of ibrexafungerp is it's activity against fluconazole resistant strains. And we are generating data to better define how VVC patients failing fluconazole treatment respond to ibrexafungerp. In the CANDLE study, the patients needed to have an acute VVC episode at the time of enrollment. The acute VVC episode was treated with 3 doses of fluconazole on days 1, 3 and 7.

The patients who resolved their acute episode after fluconazole treatment were then included in the main study to evaluate prevention of recurrence. However, those patients that did not resolve their acute VVC episode with 3 doses of fluconazole could not be enrolled in the prevention of recurrent phase of the study and where they are offered a single day of ibrexafungerp treatment, 300 milligrams BID in a nested sub-study, 24 patients were included in the nested sub-study, and 10 of them besides having persistent signing symptoms of VVC after fluconazole treatment also had documented persistent positive cultures.

The majority of these patients responded well to 1-day treatment with ibrexafungerp with 71% achieving a substantial reduction or complete elimination of signs and symptoms. This positive trend was also confirmed in the subset of subjects who, in addition to having a clinical failure also had persistent positive cultures after fluconazole treatment. Favorable clinical response after a single day of ibrexafungerp was reported in 8 of 10 subjects, 80%.

The response to ibrexafungerp in this clinically challenging population is in line with the response rates observed in the broader VVC population included in our Danish trials, illustrating the wide range of VVC patients that could benefit from ibrexafungerp, encompassing multiple scenarios within the spectrum of the disease from uncomplicated to more challenging clinical cases.

We hope to expand upon this data with the recently announced Phase IIIb VANQUISH study that is aimed to further evaluate ibrexafungerp as a VVC treatment for patients who have failed treatment with fluconazole, including those in specific populations such as immunocompromised patients. The VANQUISH study will be conducted in approximately 25 centers in the United States, aiming to enroll 150 subjects, and we are targeting to have data from this start in the second half of 2024.

In addition, we continue making progress in our development programs in the hospital setting. We have already reached our target enrollment of 200 subjects in the FURI study, and we'll soon begin study closure activities to enable completion of the follow-up of all cases by first half of next year. This will be followed by the data -- the final Data Review Committee review and the reporting of the final data, which is guided as early in 2024.

The CARES study will follow a similar time line. As a reminder, the CARES and FURI studies are evaluating ibrexafungerp in patients with candidiasis and other refractory fungal infections.

The SCYNERGIA study has continued enrolling patients also slowly. We are planning to complete the study and analyze the available data by end of this year. Also, the number of patients may be smaller than initially projected. The data from this Phase II study, even in a smaller number of subjects than anticipated will guide potential next steps for this development path.

Enrollment has begun in MARIO study, which is evaluating ibrexafungerp in patients with invasive candidiasis. The start-up process is progressing well with multiple sites already opened in the United States and South Africa and many other sites and countries will open soon.

As previously guided, we are anticipating completion of the study by end of next year. As mentioned previously, the data from the MARIO study, along with the data from FURI and CARES study are intended to be supportive of an NDA submission in 2024 with an anticipated first approval for an indication in the hospital setting later that year.

Also, after the completion of the Phase I study with the liposomal IV formulation of ibrexafungerp, we are compounding the data to enable a discussion with the FDA regarding potential development path for this formulation. We are targeting to have this consultation by end of this year.

Thank you. And I will now turn the call over to Larry Hoffman, our Interim Chief Financial Officer.

Thank you, David. BREXAFEMME increased its net product revenues from $700,000 in the first quarter of 2022 to $1.3 million in the second quarter of 2022. R&D expense for the second quarter of 2022, increased to $7.1 million from $4.7 million for the second quarter of 2021.

SG&A expense for the second quarter of 2022 increased to $15.8 million versus $12.8 million in the second quarter of 2021. The increase was driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.

Total other income was $8.4 million for the second quarter of 2022 versus total other income of $15 million for the second quarter of 2021. During the second quarter of 2022, and the second quarter of 2021, SCYNEXIS recognized non-cash gains of $9.7 million and $15.3 million, respectively on the fair value adjustment of warrant liabilities and non-cash gains of $200,000 and $500,000, respectively on the fair value adjustment of derivative liabilities.

Our cash balance is strong. Cash and cash equivalents in the second quarter totaled $118.7 million on June 30, 2022. That compares to $112.4 million on June 30, 2021 versus $104.5 million in cash and cash equivalents on December 31, 2021.

Based upon our current operating plan, SCYNEXIS believes that its existing cash and cash equivalents and the anticipated sales of BREXAFEMME will enable us to fund our operating requirements into the first quarter of 2024.

I will now turn the call over to Marco for his final remarks.

Thank you, Larry, Christine and David. Before we open the call to Q&A, I want to reiterate a few key points. We at SCYNEXIS are diligently working to realize the significant potential for ibrexafungerp as a successful, durable, and profitable antifungal franchise. We have a PDUFA date in recurrent VVC on November 30 as well as a planned readout of our SCYNERGIA data at the end of the year and additional data collection from our FURI and CARES problems.

We plan to provide updates on our progress in MARIO, which we believe can be leveraged to build a strong and differentiated hospital brand. All these indications when taken together could create a franchise with a potential to generate $700 million to $800 million a year in net sales in the U.S. alone. Operator, please open the floor for questions.

(Operator Instructions) Our first question comes from the line of Louise Chen from Cantor Fitzgerald.

This is Carvey, on for Louise from Cantor. Congrats on the quarter. I have a couple of questions here. First, we're looking forward to your PDUFA day in November as we are approaching that day. Can you talk a little bit about the added market opportunity that it will be enabling post approval?

Secondly, it's almost been a year since the commercial launch of BREXAFEMME. Can you highlight additional color on physician's feedback from the community? Also, what level of coverage are you targeting by the end of this year?

Thank you so much. This is Christine. Thank you for the question. The additional indication for recurrent VVC will give our field teams a lot of opportunity to go back into our physicians with additional data that will be helpful to them in their patients.

You probably heard me say in the prepared remarks that we, after a year of working with these physicians have tightened up our call target list to the ones that are most opportunistic and that includes this RVVC indication.

New data is always helpful, both for the physicians, their patients, but also for the rep to bring in fresh information and make a call -- the sales call fresh. So that's one thing for RVVC.

As it relates to BREXAFEMME overall and doc feedback, we do continue to get very positive feedback across all let's say, intake areas. So the reps, we always hear from the reps, we do third-party unbiased ATU, efficacy trial and usage panels as well as market research. And when I look across all of those pieces, we hear similar feedback that the doc -- and they report from their patient perspective too, that BREXAFEMME is easy to use. They love the 1-day dosing. They love the fungicide, as you heard Dr. Angulo speak about that. That's important to the doctors. And they like the fact that they see early symptom relief very, very quickly. So those are the things we hear coming back to us across all of those channels. And then your last question was on…

Coverage.

Thank you, Marco. Yes, on coverage. And right now, we're sitting at 109 million patient lives. It's about 60-ish percent of the commercial universe. I believe our target going into 2023 is 65%. So we're in the ballpark. We may be ahead of it, but you always got to wrangle these things to the ground. And so it's not done until it's done. Does that help?

Yes, it was super helpful.

If I can add. I think I can add that is there is no better feedback. I mean, just to see how many of the doctors after 25 years that have been using fluconazole, actually, they become repeat prescribers. I don't think there is any better feedback than seeing a doctor prescribing multiple times BREXAFEMME.

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

This is Farhana, on behalf of Michael. We have 2 questions. The first one is, can you provide a little bit more color on the timing of your discussions with the FDA for the Phase I data for the IV formulation?

Sure. Thank you for the question. This is David. So at this point, as I mentioned, we completed our Phase I study. The results were very positive. The drug -- the formulation was well tolerated. We were able to achieve our target exposure. And right now, we are just putting together all that information, all the pieces from that particular information along with all, obviously, our toxicology program that enabled this first Phase I study. And we're planning just to put together all that as a regulatory package to really understand with the FDA.

What will be needed in order to get this particular formulation integrated into development programs and/or to really find a path for approval that it is fast and in our opinion, should be an abbreviated path for approval for this particular formulation. So that's the pieces that we are aiming to have discussions with them.

And certainly, we have had previous discussions with the regulatory agencies regarding how to develop our intravenous formulation. And we believe that at this point with this new data, we will be in a very good position to really have a very productive discussion with them to have a clear definition of the development path to really try to bring this new formulation into our development program as soon as possible and really try to progress at it very rapidly.

Okay. And the second question that we had was when can we expect data from the FURI and CARES studies? Is it safe to say around the first half of 2023?

Well, we have guided that really the data and the submission, et cetera, is in 2024 actually. So that's what is actually there guided. And we are planning, as I mentioned, with you to really wrap up the FURI study towards -- in the remaining of this year. However, we need to remember that the treatment duration for patients in the FURI study could be long. And we obviously need to allow those patients to complete their treatment.

As I mentioned before, we are aiming to really wrap up all activities so that everyone has its last visit of treatment during the first half of next year. And from that point, we're going to be start wrapping up the data, doing data review committee and data review committee meetings, et cetera, in order to try to have that data available.

The data should be available in conjunction with or at the same time that we have the data from MARIO, so that we can really put together a regulatory package that it is -- that enabled us to have all that information together. That's the current plan. As usual, if we can accelerate that we will, and we will guide you in the future if we see an opportunity to really have data sooner than at that point.

Okay. And could you also just remind me for the VANQUISH study, do you have any timing for when that is expected to read out?

Yes, we do. So at this point, we are in the process of reinitiating all the centers for the VANQUISH study. We are anticipating approximately about 18 months of enrollment, which means that it will take us that the data -- we are anticipated the data will be sometime in 2024, probably first half of 2024. It's when we're anticipating the data from that study.

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

I have a few. If we could just start on BREXAFEMME commercial situation. Can you just give us a good sense of -- you've mentioned overall coverage with 60% of lives. What kind of co-pays are women facing at the pharmacy?

What kind of assistance are you offering both from a financial perspective, but also in helping OB-GYNs and practices get approval of these prescriptions?

What kind of pushback are they experiencing with regards to prior ops or step edit through fluconazole? Obviously, most women have already experienced fluconazole, but I'm just curious about their physician experience.

And then just you mentioned, are you continuing with all the, "Say No More" DTC promotion. I'm curious about investment levels going forward. You talked about a lot of new initiatives with the podcasting and in-store displays. Where should we see SG&A trends going forward? And I have a separate follow-up.

Great. Thank you. it's Christine. Thank you for the question. On the co-pay ranges, we -- year-end, we see a lot more data, and we see a really wide range. I mean, insurance carriers have so many different benefit designs. So Oren, we see anything from 5 out-of-pocket co-pays for the patient $5 all the way up to $600. And that, again, has to do with our benefit design and what kind of insurance they have.

The majority of our patients are in the $30 to $50 out-of-pocket range, which is good, Oren because that's from all of the research that we do from a sensitivity standpoint, that is acceptable in that range. And we still have our co-pay card that helps with cash or commercially insured, not on formulary or they don't have the coverage. We have that co-pay card continuing on Oren right now, and that will pay it down to the $30 range. So we still have those programs intact.

Now you asked about investment on advertising, which I'll talk about that later, but I'll say the same thing here from an SG&A standpoint, as you continue on into the second year, we are continuing to work with the commercial payers to get better formulary position, to get inclusion, all of these things. And as that increases our Oren then the co-pay program starts to sunset. So SG&A, you'll see trade-offs basically on that. Does that help on co-pay, I'll move to the next one.

Yes.

Okay. I will say on payers though quickly what I would say getting ready for RVVC. Our national account guys have done a tremendous job getting us positioning where we are now. And the one thing I would say to you is it's not always that payers are interested in your science or technology.

The science and technology coming off of ibrexafungerp, especially with RVVC, has opened doors for our national account guys to get back in there, have conversations to get us better positioned overall, get more access and also bring on the RVVC indication. So I should put that there because that's not given when you have a drug launch. This is a very, very strong position for us to leave that there.

Investment levels. Yes, I mean, we started in the summer this year with rolling out in earnest or in patient advertising. It's part direct-to-patient. You heard me in prepared remarks talk about putting advertising in the waiting room where the patients are sitting. That's a very strong position, the waiting room of OB-GYNs because the patients sitting there getting ready to see the doctor and may not know what to say.

So BREXAFEMME is on a loop, advertising there, talking about how you can talk to your physician about vaginal yeast infection and that there is a new product called BREXAFEMME. That's a very strong position. That's more on the direct-to-patient side, but it's good Oren because you saw the success in quarter 2. That was based on our national sales director, tightening up execution in those targeted offices.

Now if you put advertising to the patient in those same offices and our national sales director continues with the focus of the rep. In those offices, that will be very, very fruitful for us. Now on the consumer side, I use the word "foray" in my prepared remarks. We have put advertising in the aisles of these local and national drugstores and pharmacies, right?

So if someone is searching towards, I used the word Monistat. They're looking for that, and they're in the aisle. They will see what's called a shelf topper. It will be on there -- obviously, specific drugstores and pharmacies, we can't go with that everywhere. And it will message them about BREXAFEMME. So that's going to be interesting, Oren, to see what happens there because it's a really strong connect to a motivated consumer who's in the aisle thinking about purchasing something to help them.

But then, Oren, it's a longer lead because then she's got to call the doctor, get in to see the doctor and all these things. So I look forward to reporting back to you on that. I think we're going to see differing levels of results from these 2 tests, but I think they'll be successful nonetheless. We'll see what SG&A reallocation what that looks like once I get the results on these because obviously, you want to throw more money where you're getting the return.

And right now, if I can -- Oren, if I can jump in, but in terms of the SG&A expenses, we are just planning and we are doing -- we are keeping it flat. Again, Christine and her team are always looking eventually to reallocate their -- what they have allocated resources in order to maximize what we see the best return.

So we continue to assess these initiatives, their return, eventually reallocate, but we keep the SG&A, and you will see we will keep the SG&A flat and that's really looking at ways to even improve it as we progress.

All right. And if I can be greedy on time. Are you hearing any feedback from the community, KOLs or otherwise with regards to the approval of Mycovia as product? I don't think it's launched yet, correct? But presumably, there's some awareness out there, and I'm wondering what kind of initial feedback you're hearing?

Actually it's internists, I think, as I think of it. Mycovia has been approved with a very, very restricted labeling due to the fact that they have extremely long half-life after termination of treatment. The trial will be in the body of the patient for almost 2 years. And due to the potential of embryotoxicity, FDA has really limited the use of Mycovia only for women who are permanently and biologically sterile, so postmenopausal, hysterectomy patients who have hysterectomy and so on.

We see also a silver lining in the approval that has been launch. We know that now has been priced. The product has been priced and is available on specialty pharmacies. I don't think on retail pharmacies actually available. But we see also the silver lining of having another company that talks about the fact that there are alternatives to fluconazole.

And of course, when we will be approved with our indication, where we don't expect to have this type of restrictions that will put us in really on the offering a product that addresses the current VVC and actually without all the limitations and the risk associated with the Mycovia product. So I think that, as I mentioned before, it's a good thing that there is finally some innovation after 25 years in the field of vaginal yeast infection. So we wish all the best also to our colleagues at Mycovia that will help to send the message, but alternatives are becoming available.

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

With regard to the liposomal formulation, how quickly will you be able to start a trial following the interaction with the FDA? And how should we think about these trials?

How quickly? I would say just soon. I'm not going to give you that soon because the reality is that we have all the manufacturing pieces, et cetera, are ready. So once we agree with the design of the proper study, I think that we will be able to release that implementation very rapidly after that.

And what we are -- what I'm anticipating that contingent upon discussion with them is that we will need some level of potentially Phase II or Phase II, Phase III type of trial first. And that's what we really want to discuss with them. So we may need to have an initial evaluation of -- the product has been evaluated so far in healthy volunteers.

We will need to evaluate the product in patients and to release the tolerability in patients and then to expand a little bit in a broader number of patients that are going to be receiving having a sufficient number of safety information associated with the drug.

So that's what we are in the purpose of really putting together a package for discussion with the agency. Will this be a combined Phase II/Phase III approach that there need to be to separate studies, how big they are? What should be the endpoints to assess?

How can we bridge with all the very solid package of safety information that we already have with ibrexafungerp when given orally in a very, very large population setting in which we have been clearly been able to define the safety of the product. So those are the pieces that we are really aiming to discuss with them. And we are optimistic that with the information that we have on hand right now, it will be -- we will be able to reach an agreement with the agency of a very reasonable and efficient development path forward.

Okay. And with regard to the BREXAFEMME label expansion, what are the expectation of time line for payer negotiations? And what are the expectations in terms of co-pay in that setting? And also, you touched on SG&A, how should we think about SG&A later for the later part of the year once potentially BREXAFEMME gets approved in the new indication?

It's Christine. Thank you for the question. Payer negotiation tests begun months ago. So we're always in conversations. The national account directors are always in open conversations with our customers. That's one of the strengths of our team out there.

And so when appropriate, they brought in information to start to talk about where we're going next with the ibrexafungerp molecule. And they'll continue doing that, Kumar, throughout the rest of this year going into next. The other question was on SG&A, Kumar as it relates to the second indication, is that correct?

Yes, that and also the co-pay in terms of the new indications, what are -- what would be the expectation in terms of co-pay there? And also how quickly you'll be able to get this like you have like 60% covered life right now, how quickly we'll be able to get there in the expanded indication?

Yes. I mean, again, the national account guys will have to conclude their conversations with the customers to see exactly how the payer is going to look at it, right? That's why we started these conversations so early in the year.

I think we will be directionally aligned as it relates to the co-pay that we discussed earlier. So we'll have to wait to see Kumar how exactly the payer treats the second indication. But again, we're well out ahead of it. They love the molecule. It's a different class. So we're in a really strong position there. And then your -- the last question was on the SG&A. Yes.

That's right. Like how is that expected to change once you have the new label, yes?

Yes. I think, Kumar, you're looking for kind of the balance between the 2 indications in promotion. So our marketing team already is developing materials that will have both of the indications in the materials. So the field sales representatives can have the conversation about both indications. And there's a lot of synergy in that discussion, which is really great because it makes the sales call much more efficient, but also valuable to the doctor.

Sometimes you get a second indication, and it's like totally different than the first indication, but this one has a very nice story, as we said earlier, about BREXAFEMME being the first and only treatment, vaginal yeast infection, treat and prevent VVC. So there'll be some very nice conversations in the doctor's office with the rep.

So the SG&A will stay as it is right now because we've already accounted for that and the marketing teams are already well on their way developing these materials Kumar, because we'll execute on this in the first quarter of next year.

Okay. Finally, if I may sneak in, how should we think about going forward with regard to COGS?

Cost of goods. Yes, we are -- thank you for the question. This is David. So we are always, as you can imagine, finding the ways to optimize our cost of goods. And as we continue to manufacturing more and more batches and as we continue selling more and more products, we are enhancing our opportunity to have larger production batches, et cetera, and to potentially continue reducing our COGS.

And so just the continued market expansion, so to speak, plus the clinical development, all those pieces together are allowing us to obviously have much more favorable conditions to really try to continue bringing down our COGS. That will continue progressing as we continue evolving in the market. So as we continue to relate to manufacturing more and more, it's only expected to get better and better. That's what I can tell you right now.

(Operator Instructions) Our next question comes from the line of Steve Brozak from WBB Securities.

Yes. Most questions have been asked and answered, but I do have 2. Can you remind us what the number of visits and number of scripts, the typical patient has had so far? And I would imagine the number of scrips would have been specifically around fluconazole. But can you just refresh us with that? And I've got one more question after that, please.

I want to make sure we understand the question, Marco. Did you -- are you on the question?

Yes, I can start. Steve, as we have shown actually in some of our materials that we have shown over time, about 40% of the patients receiving a prescription of fluconazole. Actually, they need another prescription. And actually, you have about 20% of the patients requiring 3, 4, 5 or even more prescriptions. Of course, many of these repeat prescriptions will also require additional visits to a doctor.

So I think you are clearly highlighting one of the major concern, but has been so far with the treatment of fluconazole that probably due -- again, to its mechanism of action, which is fungistatic and not fungicidal like the one of BREXAFEMME, you have patients where some candidates will survive the treatment.

Of course, patients may feel a short-term improvement, but then Candida start to grow again because it has not been completely killed. So I think that you are raising a very good point. And I think that probably this is one of the reasons why the doctor has been really very pleased with the treatment of BREXAFEMME. And now I will ask maybe Christine to see what has been the feedback from doctors about this issue of patients, who have multiple failures to fluconazole and use BREXAFEMME.

Yes. I think -- thank you so much for that. Hi, Steve, it's Christine. What we're hearing from the doctors is kind of what we've been discussing for a while now is they don't like to see their patients come back. It's not good for them -- for the doctor.

And of course, the patient isn't feeling great either. And so what they have been excited about the physicians is that BREXAFEMME helps with that situation and that they see early symptom relief, the patients are happy. They're not getting the callbacks or the patient coming back in for either to your point, Marco, additional products or something else.

The other thing I will say what I see with our customers is it gives them the physician customers a sense of relief because when you don't have an option, we talked about this early in launch. You're left to do what you have, which is, like you said, Marco, fluconazole or others, and it may not be the optimal solution. And so the physicians had degrees of discomfort and anxiety for their own patients because they couldn't give them something else. So BREXAFEMME has helped alleviate that. So that's been a very positive response.

Thank you, Christine. And Steve, if I can add also another important point is that the fact that BREXAFEMME is able to address the issue in these patients who failed multiple times fluconazole. Now we have some really hard data, as shown by David with these patients in the CANDLE study who received 3 doses of fluconazole, which by way I'd like to remind people is 3x the approved dose of fluconazole, and they did not respond to free doses of fluconazole, actually, they responded well with more than 70% of the patients to 1 single day of BREXAFEMME.

And this, of course, is -- makes satisfied patients, doctors and payers, patients because finally, that problem is addressed, doctors because they don't see their patients coming back multiple times for the same issue, as you can imagine, the frustration that this creates both in patients and doctors.

And finally, it is also good health economics for the payers because they see clearly the reduced numbers of business. So I believe that now that we have also new data, and we will -- we expect with the VANQUISH study to even further confirm in a larger well-designed study specifically designed to address this question to show that BREXAFEMME is a good solution for patients who are not responding to fluconazole.

Okay. I appreciate that cariole answer and the detail. Last question. Your approach with an opera-like audiences is fascinating. But I do have on the other side of the spectrum, what inroads and what have your thoughts been around things like concierge medicine?

Because obviously, it's one of those things where you start to see the practical clinicians that are going out there. and taking their -- taking care of their patients on a more personal and on a more focused level. What kind of inroads have you made there, if any? And what are your thoughts around that? And I'll hop back in the queue.

Yes. Thanks, Steve. Yes, these verticals, they're very interesting, and they do have their strengths the -- what I would say to you at this time is our marketing team has looked at a few of them and continues their evaluation of them. And as I said earlier, I think I was talking to Oren, we really have to be mindful with where we put our money to make sure the return is there. So I would say to you, Steve, our evaluation is not complete on that as of yet. And if it becomes something that is a tool for us, obviously, you'll hear us speak of it, but to be continued at this point.

Ladies and gentlemen, we have reached the end of the Question-and-Answer Session. I would now like to turn the conference over to Mr. Marco Taglietti for closing comments.

Thank you very much. First of all, to everyone for listening to our teleconference. I will just make one brief -- just a brief statement that we continue to remain very optimistic about the potential of BREXAFEMME and overall of ibrexafungerp becoming a long-lasting, important antifungal franchise.

And of course, we remain very optimistic about the future of SCYNEXIS because we have the resources actually to achieve our plans. Thank you very much, and have everyone, a wonderful day. Operator?

Thank you. The conference has now concluded. Thank you for your participation. You may all disconnect your lines.