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spk09: ladies and gentlemen good morning and welcome to the synexis inc second quarter 2022 earnings conference call at this time all participants are in a listen-only mode a question and answer session will follow the formal presentation if anyone should require operator assistance during the conference please press star 0 on your telephone keypad as a reminder this conference is being recorded I will now turn the conference over to Ms. Debbie Acheson, Communications and Investor Relations. Please go ahead.
spk04: 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 document subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, August 15, 2022. Cenexus 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 Cenexus 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'll turn the call over to Dr. Marco Taglietti, President and CEO.
spk07: Thank you, Debbie. Good morning, everyone. Buongiorno a tutti. Thank you for joining us today for our second quarter of 2022 earnings investor calls. Things are moving forward nicely here at Senexis. We are now one of the leading standalone anti-infective companies, a sector market 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 toward expanding the labeling and the use of iBrexaphone GERP. We launched iBrexaphone GERP with brand name Brexaphone last summer, and we have seen a steady adoption of Brexaphone despite the headwinds of the macro environment. 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 projects catalysts in 2022 and beyond. We continue to move Synaxis onward. Let me briefly summarize a few key accomplishments of the second quarter. FDA has assigned a November 30th, 2022 PDUFA date for our supplemental new drug application to expand the labeling of Brexfam to include the recurrent VVC indication. If approved for this second indication, Brexafem will be the only, only antifungal approved for both treatment of DBC and prevention of recurrent DBC. 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 3B vanquished study of oralibrexafum gerb in DBC patients who don't respond to fluconazole treatment. The goal of this trial is to further demonstrate Ibrexa-Punger's efficacy in treating the most challenging BVC 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, Brexafen, a Brexafen tablet, which Synexis launched in September 2021, achieved over 5,100 prescriptions and reached 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 toward achieving our mission to meet the significant unmet needs 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 VDC 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?
spk05: 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 BREXFM 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 their 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 VDC indication, and enhance the HCP and patient say no more campaign. These plans will set us up for continued success. The most significant opportunity for BrexFM continues to be the treatment of VBC. Additionally, with the anticipated approval of our SNDA, BrexFM will be the first and the only therapy to both treat and prevent VBC and is on track to have the broadest VBC indication. We expect that a broader label will expand prescriber confidence of BrexFM along with wider utility of BrexFM. Over the last several quarters, we have continually grown the number of Brexifem prescribers. In quarter two, over 2,200 HCPs prescribed Brexifem, 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 Brexifem with a broader range of patients. RexFM 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 release messaging. In our recent HCP research audit and regional advisory boards, HCPs continue to report to us that they intend to use BrexFM 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 BVC patients who are waiting for a new solution by disrupting the decades-old habit of using generic treatment and establishing Brexifen as the gold standard for BVC. 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 Brexfem for women within these plans. Payers continue to see the value of Brexfem and are motivated by its differentiating benefits, especially that it is fast and effective in curing VBC. During the last call, I shared with you our Say No More HCP in-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 two. 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 Brexifem, they are motivated to learn more about a one-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 BrexFM. The new patient advertising has increased site traffic to brexfm.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's more we must learn to optimize our efforts here. Recently, we conducted market research with patients to explore the topic and treatment of DVC. 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 three, we are executing additional exciting new patient programs that will continue empowering women to ask their HCP for Brexifem. These programs include a custom Brexifem ad that will be playing during the Oprah Winfrey Super Soul podcast for three months, This podcast is expected to deliver 4.2 million impressions to our targeted audience in quarter three. We have also partnered with both national and local pharmacies and grocery stores across the country to place Brexifen 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 Brexifem. 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 their HCP if Rexafen is the right treatment option for them. These focused prescriber and patient efforts complement the groundwork of our Synexis National Sales Director, whom we brought on in May. who has focused on increasing the effectiveness of our Salesforce effort and maximizing their impact. Over the past year, we have learned which HCPs are motivated to prescribe Brexifem 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 Salesforce with the necessary tools to be successful. There is a large opportunity and significant unmet need in BBC, 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.
spk03: Thank you, Christine. We have continued making progress towards a vision of developing iberexafungal for the treatment and prevention of multiple fungal infections. Earlier this year, we submitted a supplemental MDA for the indication of prevention of recurrent VBC. And as recently announced, we received notice from the FDA that our application was accepted and was granted priority review with a target regulatory decision date of November 30th. This submission was based on the positive results from our Phase III study, CANDL. As previously reported and recently presented in more detail at the Infectious Disease Society OB-GYN meeting in Boston, the CANDL study met its primary endpoint, with 65.4% of RBDC patients treated with ibrexafungur achieving clinical success. with no recurrence at all, either culture proven, presumed, or suspected after treatment with ibrexafungus. Ibrexafungus 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, ibrexafunga studies continue to demonstrate its ability to not only treat acute infections, but also prevent recurrences of the disease. If this second indication is approved, brexafen will be the first and only product approved in the United States that is indicated for both the treatment of VBC and the prevention of recurrent VBC. One important attribute of ibrexafungur is its activity against fluconazole-resistant strains. And we are generating data to better define how VDC patients failing fluconazole treatment respond to ibrexafungur. In the CANDL study, the patients needed to have an acute VDC episode at the time of enrollment. The acute VDC episode was treated with three doses of fluconazole on days one, three, and seven. 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 VBC episode with three doses of fluconazole could not be enrolled in the prevention of recurrence phase of the study, and were there offered a single day of ibrexafungal treatment 300 milligrams BIV in a nested sub-study. Twenty-four patients were included in the nested sub-study, and ten of them, besides having persistent sign and symptoms of VBC after fluconazole treatment, also had documented persistent positive cultures. The majority of these patients responded well to one-day treatment with ibrexafungur. 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 ibrexafunga was reported in 8 of 10 subjects, 80%. The response to ibrexafungur in this clinically challenging population is in line with the response rates observed in the broader BBC population included in our Danish trials, illustrating the wide range of BBC patients that could benefit from ibrexafungur, 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 3B vanquish study that is aimed to further evaluate ibrexafunga as a BDC 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 study 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 FUTI study and will 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 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 timeline. As a reminder, the CARES and FUTI studies are evaluating ibrexifungal in patients with candidiasis and other refractory fungal infections. The Synergia study has continued role in 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's study, which is evaluating ibrexafunga in patients with invasive candidiasis. The start-up process is progressing well, with multiple sites already open 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 FURY and CARES study, are intended to be supportive of an MDA 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 one study with the liposomal ID formulation of ibrexafungur, we are compiling the data to enable a discussion with the FDA regarding potential development paths 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 or interim chief financial officer.
spk00: Thank you, David. Rex FM 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 Brexifem. 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, Cenexis 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 of 2022. That compares to $112.4 million on June 30 of 2021 versus $104.5 million in cash and cash equivalents on December 31st of 2021. Based upon our current operating plan, Synexis believes that its existing cash and cash equivalents and the anticipated sales of BrexFM 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.
spk07: Thank you, Larry, Christine, and David. Before we open the call to Q&A, I want to reiterate a few key points. We at Senexis are diligently working to realize the significant potential for a brexaphone germ as a successful, durable, and profitable antifungal franchise. We have a due date in recurrent BBC on November 30th, as well as a planned readout of our Senex data at the end of the year. and additional data collection from our FURI and CARES programs. 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 the potential to generate $700 to $800 million a year in net sale in the US alone. Operator, please open the floor for questions.
spk09: Thank you, sir. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from the line of Luis Chen from Cantor Fitzgerald. Please go ahead.
spk02: Hi, good morning, everyone. This is Carby on for Luis from Cantor. Congrats on the quarter. We have a couple of questions here. First, we're looking forward to your producer day in November. As we're 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 Brexifan. Can you highlight additional color on physician feedback from the community? Also, what level of coverage are you targeting by the end of this year? Thank you so much.
spk05: Thank you so much. Hi, this is Christine. Thank you for the question. The additional indication for recurrent BVC will give our field teams a lot of opportunity to go back into our physicians with additional data that will be helpful to them and 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 RBVC indication. New data is always helpful, both for the physicians, their patients, but also for the reps to bring in fresh information and make the call, the sales call, fresh. So that's one thing for RBDC. As it relates to BREX FM 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, Attitude Trial and Usage panels, as well as market research. And when I look across all of those pieces, we hear similar feedback that the docs, and they report from their patient perspective, too, that BrexFM is easy to use. They love the one-day dosing. They love the fungicidal. 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 things we hear coming back to us across all of those channels. And then your last question was on coverage. Thank you, Monica. Yes, on coverage. And right now we're sitting at 109 million patient lives. That's about 60-ish percent of the commercial universe. I believe our target going into 2023 is 65 percent. 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?
spk02: Yeah, it was super helpful. Thank you so much, and congrats.
spk07: And if I can add, yeah, if I can add, there is no better feedback than 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 Brexfem. Thank you.
spk11: Thank you.
spk09: Thank you. Our next question comes from the line of Michael Higgins from Leidenberg Thalmann. Please go ahead.
spk01: Hey, guys. Good morning. This is Farhana on behalf of Michael. Congrats on the great quarter. We have three questions. The first one is, could 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?
spk03: Sure. Thank you for the question. This is David. So at this point, as I mentioned, we completed our phase one study. The results were very positive. 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 one study. And we're planning just to put together all that as a regular study package to really understand with the FDA what will be needed in order to get this particular formulation integrated into the development program 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 discussion 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 it very rapidly.
spk01: Okay, great. Thanks. And the second question that we had was, when can we expect data from the FUTI and CARES studies? Is it safe to say around the first half of 2023?
spk03: 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're planning, as I mentioned with you, to really wrap up the FUTI study. in the remaining of this year. However, we need to remember that the treatment duration for patients in the FUTI 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 data, doing data review committee meetings, et cetera, in order to try to have the 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 enables us to have all that information together. That's the current plan. usually 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 great thanks and now 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 we are in the process of really initiating all the centers for the vanquish study and We are anticipating approximately about 18 months of enrollment, which means that it will take us to the data. We're anticipating the data will be sometime in 2024, probably first half of 2024 is when we're anticipating the data from that study.
spk01: Okay, great. Thank you so much for taking our questions.
spk03: Sure. Thank you for the questions.
spk09: Thank you. Our next question comes from the line of Oren Lisnet from HC Wainwright. Please go ahead.
spk08: Thanks. I have a few. If we could just start on the BruxFM commercial situation. Can you just give us a good sense of, you know, 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 you know, in helping OBGYNs and practices get approval of these prescriptions? You know, what kind of pushback are they experiencing, you know, with regards to prior auths or step edits through fluconazole? Obviously, most women have already experienced fluconazole, but I'm just curious about their physician experience. And then just you mentioned, you know, are you continuing with all the Say No More DTC promotion? You know, I'm curious about investment levels going forward? You talked about a lot of new initiatives with the podcasting and store displays. Where should we see SG&A trends going forward? And I have a separate follow-up.
spk05: Great. Thank you. Good morning, Oren. It's Christine. Thank you for the question. Hi. On the co-pay ranges, a year in, 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 five to Out-of-pocket copay for the patient, $5 all the way up to $600. And that, again, has to do with their 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, that range. And we still have our copay card that helps with cash or commercially insured insurance not on formulary or they don't have the coverage, we have that copay 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, Oren, then the co-pay programs start to sunset. So as Gina, you'll see trade-offs, basically, on that. Does that help on co-pay? I'll move to the next one. Yep. 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 Brexit Thunder, especially with RVVC, has opened doors for our national account guys to get back in there, have conversations to get a better position overall, get more access, and also bring on the RVVC indication. So I should put that there because that's not a given when you have a drug launch. This is a very, very strong position for us. So I'll leave that there. Investment levels. Yeah, 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 OBGYNs, because the patient's sitting there getting ready to see the doctor. and may not know what to say. So if BrexFM 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 BrexFM, 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 two. 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 drug stores and pharmacies. If someone is searching for, I use the word monistat, they're looking for that and they're in the aisle, they will see what's called a shelf talker. It will be on there in obviously specific drugstores and pharmacies. We can't go everywhere. And it will message them about Brexifen. So that's gonna 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, you know, it's a longer leave 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 two paths, 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.
spk07: And right now, if I can jump in, but in terms of SG&A expenses, we are just planning and we are keeping it flat. Again, Cristina and her team are always looking eventually to reallocate what they have allocated the resources in order to maximize what we see the best return. So we continue to assess This initiative, their return, eventually reallocate, but we keep the SG&A, and you will see we will keep this SG&A flat and actually looking at ways to even improve it as we progress.
spk08: All right, and if I can be greedy on time, are you hearing any feedback from the community, you know, KOLs or otherwise with regards to the approval of Mycovia's 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?
spk07: I think that my call has been approved, but with a very, very restricted labeling due to the fact that they have an extremely long half-life. You know, after termination of treatment, the drug will be in the body of the patient for almost two years. And due to the potential of embryo toxicity, FDA has really limited the use of mycovia only for women who are permanently and biologically sterile. So post-menopausal, you know, hysterectomy, patients who have hysterectomy, and so on. So we see also a silver lining in the approval. The 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 it's 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 really on the offering a product that addresses recurrent VBC and actually without all the limitations and the risk associated with the mycovia product. As I mentioned before, it's a good thing that there is finally some innovation after 25 years in the field of vaginal yeast infections. So we wish all the best also to our colleagues at Mycovia, you know, that will help to send the message that alternatives are becoming available.
spk11: All right. Thank you. I appreciate it.
spk09: Thank you. Our next question comes from the line of Kumar Raja from Brooklyn Capital Markets. Please go ahead.
spk10: Thanks for taking my questions. 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 this trial?
spk03: 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 really start implementation very rapidly after that. And what I'm anticipating, but contingent upon discussion with them, is that we will need some level of potentially phase two or slash phase two, phase three type of trial first. And that's what we really want to discuss with them. So we may need to have a 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 really see tolerability in patients and then to expand a little bit in a broader number of patients that are going to be receiving and having a sufficient number of safety information associated with the drug. 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 two slash phase three approach? Does it need to be two 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 Ibrexafunga when given orally in a very, very large population setting in which we have been clearly being 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, we will be able to reach an agreement with the agency of a very reasonable and efficient development path forward.
spk10: Okay, thank you. And with regard to the Brexit Fund label expansion, what are the expectation of timelines for payer negotiations? And what are the expectations in terms of copay in that setting? And also, you touched on SC&A. How should we think about SC&A later for the later part of the year, you know, once potentially Brexit Fund gets approved in the new indication? Thank you.
spk05: Hi, Kumar. It's Christine. Thank you for the question. Payer negotiations have begun months ago, so we're always in conversations. The national account directors are always in open conversations with their 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 Abrexa Funger 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?
spk10: Yeah, that and also the co-pay in terms of the new indications. What would be the expectation in terms of co-pay there? And also, how quickly you'll be able to get to this? Like, you know, you have like 60% covered life right now. How quickly will you be able to get there in the expanded indication? Okay.
spk05: Yeah, 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. That's why, you know, we started these conversations so early in the year. I think we will be directionally aligned as it relates to the copay 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 the last question was on the SG&A. No.
spk10: That's right. Like how is that expected to change once you have the new label? Yeah.
spk05: Yeah. I think, Kumar, you're looking for kind of the balance between the two 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 representative can have a 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 Brexfem being the first and only treatment vaginal yeast infection treat and prevent VBC. So there'll be some very nice conversations in the doctor's office with the reps. 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.
spk10: Okay, finally, if I may sneak in, how should we think about going forward with regard to COGS?
spk03: Oh, cost of goods. Yeah, we are, Kumar, 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 manufacturing more and more batches and as we continue selling more and more product, 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 really manufacturing more and more, it's only expected to get better and better. That's what I can tell you right now.
spk10: Okay, great.
spk11: Thanks so much. Thank you.
spk09: Ladies and gentlemen, if you wish to ask a question, please press star one. Our next question comes from the line of Steve Brozek. from WBB Securities. Please go ahead.
spk06: Yes, thanks for taking the question. Most questions have been asked and answered, but I do have two. 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 scripts would have been specifically around fluconazole. But can you just refresh us with that? And I've got one more question after that, please.
spk05: I want to make sure we understand the question, Marco. Are you clear on the question?
spk07: Yes, I can start. Steve, as we have shown actually in some of our material 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 three, four, five, 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 concerns that there 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 brexafen, you have patients where some candida 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 Brexfem. 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 Brexfem.
spk05: Yeah, 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, you know, 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, you know, feeling great either. And so what they have been excited about, the physicians, is that Brexifem 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 late. for either, to your point, Marco, additional product or something else. The other thing I will say, what I see with our customers is it gives 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, Fluconisol, or others, and it may not be the optimal solution, and so the physicians had, you know, degrees of discomfort and anxiety for their own patients because they couldn't give them something else. So Brexfem has helped alleviate that. So that's been a very positive response.
spk07: Thank you, Christine. And Steve, if I can add also another important point is that the fact that Brexfem is able to address the issue in these patients who failed multiple times to consult, now we have some really hard data, as shown by David, with these patients in the candle study who received three doses of fluconazole, which, by the way, I'd like to remind people is three times the approved dose of fluconazole, and they did not respond to three doses of fluconazole. Actually, they responded well, with more than 70% of the patients, to one single day of Brexfem. And this, of course, makes satisfied patients, doctors, and payers. Patients because finally their 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, is also good as economics for the payers, because they see clearly the reduced numbers of visits. So I believe that now that we have also new data, and 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 Brexfem is a good solution for patients who are not responding to fluconazole.
spk06: Okay. I appreciate that carry-all answer and the detail. Last question. Your approach with an Oprah-like audience 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 into Q. Thank you.
spk05: Yeah, thanks, Steve. Yeah, those verticals, you know, they're very interesting and they do have their strengths to them. 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 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. Thank you.
spk11: Got it. Thanks again. Of course.
spk09: Thank you. 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 Tagliatti for closing comments.
spk07: Thank you very much, first of all, to everyone for listening to our teleconference. I will just make one brief statement that we continue to remain very optimistic about the potential future of Brexafen and overall of Ibrexafen GERP of becoming a long-lasting, important antifungal franchise. And of course, we remain very optimistic about the future of Synexis because we have the resources actually to achieve our plans. Thank you very much and have everyone a wonderful day. Operator?
spk09: Thank you, sir. Thank you. Thank you for your participation. You may all disconnect your lines.
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