VNDA Conference Call

Hello and thank you for standing by. My name is Mark and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2025 Vanta Pharmaceuticals Inc. Earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press STAR followed by the number one on your telephone keypad. And to withdraw your question, press star one again. Now I would like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

Thank you. Mark. Good afternoon and thank you for joining us to Discuss Vanda Pharmaceuticals third quarter 2025 performance. Our third quarter 2025 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. in addition, we are providing live and archived versions of this conference call on our website. Joining me on Today's call is Dr. Mihalis Polymeropoulos, our President, Chief Executive Officer and Chairman of the Board, and Tim Williams, our General Counsel. Following my introductory remarks, Mihalis will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions. Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward looking statements within the meaning of federal securities laws. Our forward looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. These risks are described in the Cautionary Note regarding Forward Looking Statements, Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recent Annual report on Form 10K as updated by our subsequent quarterly reports on Form 10Q, current reports on Form 8K and other filings with the SEC which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings. The information we provide on this call is provided only as of today and we undertake no obligation to update or revise publicly any forward looking statements we may make on this call on account of new information, future events or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO, Dr. Mihalis Polymeropoulos.

Thank you very much, Kevin, and good afternoon everyone. Thank you for joining us to discuss Vanda's third quarter 2025 results. This quarter reflects strong commercial execution with total net product sales reaching 56.3 million up 18% year over year, led by a 31% increase in FANAPT sales and 35% growth in prescriptions. Hetlios continues to deliver stable performance with $18 million in Q3 sales. We are particularly encouraged by our advancing pipeline with multiple near term regulatory milestones. The Tradipotent NDA for Motion Sickness under FDA review with a PDUFA Target Action date of December 30, 2025 the Visanti NDA for Bipolar I disorder and Schizophrenia also under FDADPU with a PDUFA Target action date of February 21, 2026 and the anticipated Q4 submission of the imsidolimab BLA for generalized osteoporosis. We're also investing strategically in our commercial infrastructure including increased brand visibility through targeted sponsorships with the goal of supporting long term market leadership and future commercial launches. We believe that these milestones, combined with our collaborative framework with the FDA will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond on commercial updates during the third quarter our FNAF sales force further expanded their efforts and we continued our broad awareness campaign. FANAPT revenue increased by 31% compared to the same period in the prior year driven by the launch of the Bipolar I indication. FANAPT is now promoted in the US across all 50 states with a dedicated sales force of approximately 300 representatives. With the expansion of the sales force that was largely completed during the second quarter, we observed a significant increase in activity and with the total number of calls growing by more than 20% as compared to the second quarter of 2025 and growing by over 100% compared to Q3 of 2024. Since the bipolar loans demand is measured by total prescriptions, TRX new prescriptions and new to brand prescriptions reached new highs in the third quarter. The commercialization of an app is also supported by a broad speakers program operating across the country that educates prescribers on the profile of an app and how to use it. We're excited by the progress our commercial organization has made as we continue to support the commercialization of anapt, aiming for further growth in the coming periods. Total revenue from our three commercial branded products, PanAPT, Hetlius and Ponbori reached 158.9 million in the first nine months of 2025. Hetlios continues to be the market share leader despite the availability of three generic products, a testament to the brand loyalty of our patient customers over the last 11 years. We're continuing to build out and training of our dedicated Ponvori salesforce team addressing prescribers for multiple sclerosis in the last two quarters, we saw an increase in underlying face and demand as we intensified our consumer and prescriber awareness programs during the first nine months of 2025. Our direct to consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and our products FANAPT and Ponvori. We maintained strategic investments in our commercial infrastructure including increased brand visibility through target sponsorships with the goal of supporting long term market leadership and future commercial launches. Key regulatory Clinical updates Collaborative Framework for Resolution of Disputes with the FDA on October 1, 2025, we announced a collaborative framework with the US Food and Drug Administration for the resolution of certain disputes regarding Hatlius and Tradipitant. Pursuant to the agreement, the FDA will conduct an expedited re review of the partial clinical hold preventing long term clinical status of Tradipitant for the treatment of morsoon sickness by November 26, 2025. The FDA will continue its review of Anda's new drug application for this indication with the existing Prescription Drug User Fee Act Target action date of December 30, 2025 the FDA will conduct an expedited review of Andrea's supplemental new drug application SNDA for Heplius for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on on the sleep related aspects of jetlife disorder. The NDA for Bysanti for the acute treatment of bipolar I disorder and the treatment of schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026. If approved, exclusivity for byzanti, including pending patent applications, could extend in the 2000s. Bisanti is a new chemical entity which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone in clinical studies. Milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies were presented late May at the 2025American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bisanti Phase 3 clinical study for use as one's daily adjunctive treatment for major depressive disorder is ongoing and rolling patients results are expected in 2026. We plan to randomize approximately 500 patients who do the clinical study across approximately 50 sites and as the number of patients randomized increases, we'll be in a better place to estimate the time to completion. The NDA for trudipitant for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Banda initiated clinical trial study Trudipitan in the prevention of vomiting induced by GLP1 analog WeGovi semaglutide. The trial is now complete and results are expected in the fourth quarter of 2025. Iloperidone long actin injectable the phase three study of the long acting injectable formulation of iloperidone in the treatment of schizophrenia and relapse prevention is ongoing and enrolling patients. We plan to randomize approximately 400 patients into the clinical study across approximately 60 sites. In general, we have seen similar clinical studies run by other organizations and they take around two years to complete. As the number of patients randomized increases will be in a better place to estimate completion of that study. A clinical study of the long acting injectable formulation of iloperidone in people with treatment resistant hypertension is now ongoing and VANDA plans to begin enrolling patients soon. Imsidolimab A BLA for imsidolimab in the treatment of a rare orphan disorder generalized postcular psoriasis is expected to be submitted to the FDA in the fourth quarter of 2025. PNVORI investigational new drug applications for Ponvori in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Vanda has initiated the psoriasis study and plans to initiate the study in ulcerative colitis in early 2026. Early stage program highlights VKW765 and Alpha7 nicotinic acetylcholine receptor parasol agonist is currently in clinical development for the treatment of acute performance anxiety in social situations. VANDA has initiated the Phase 3 program and is enrolling patients. We plan to randomize approximately 500 patients into the clinical study across approximately 30 sites and as the number of patients of randomization increases again, we'll be able to estimate time to completion. The IND for VCA894A in the treatment of sarcoma tooth disease, axonal type 2s or CMT2s and inherited peripheral neuropathy for which there is no available treatment was accepted by the FDA in 2024. Previously in 2023, VCA894A was granted orphan Drug designation for the same indication. The phase 1 clinical study for VCA894A enrolled the patient who has already received several doses of VCA894A. With that, I'll turn now to Kevin to discuss our financial results. Kevin thank you, Mahalis.

I will begin by summarizing our financial results for the first nine months of 2025 before turning to discuss the third quarter of 2025. Total revenues for the first nine months of 2025 were 158.9 million, a 9% increase compared to 145.6 million for the same period in 2024. The increase was primarily due to growth in FANAPT revenue as a result of the bipolar commercial launch. FNAP net product sales were 84.1 million for the first nine months of 2025, a 24% increase compared to 67.6 million in the same period in 2024. This increase to net product sales relative to the first nine months of 2024 was attributable to an increase in volume partially offset by a decrease in price net of deductions. Turning to Hetlios, Hetlios net product sales were 55 million for the first nine months of 2025, a 3% decrease compared to 56.6 million in the same period in 2024. The decrease to net product sales relative to the first nine months of 2024 was attributable to a decrease in volume. Of Note, through the third quarter of 2025, Hetlios continues to retain the majority of market share despite generic competition for now, two and a half years. And finally, turning to Ponvori Ponvori net product sales were 19.8 million for the first nine months of 2025, a 7% decrease compared to 21.3 million in the same period in 2024. The decrease in net product sales relative to the first nine months of 2024 was attributable to a decrease in price net of deductions. For the first nine months of 2025, Vanda recorded a net loss of $79.3 million compared to a net loss of $14 million for the same period in 2024. The net loss for the first nine months of 2025 included an income tax benefit of $21.4 million as compared to an income tax benefit of $2.4 million for the same period in 2024. Operating expenses for the first nine months of 2025 were $269.7 million compared to 176 million for the same period in 2024. The $93.7 million increase was primarily driven by higher SG and A expenses related to spending on Vanda's commercial products as a result of the commercial launches of FANAPT bipolar disorder and Ponvorium multiple Sclerosis and higher R and D expenses primarily related to the exclusive global license agreement with an APTUS for the development and commercialization of Imsidolumab which was entered into during the first quarter of 2025. During 2024 and 2025 we commenced a host of activities as a result of the commercial launches of finapt in bipolar disorder and Ponvori in multiple sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs during the first nine months of 2025. Our direct to consumer campaign launched in the first quarter came continue to drive meaningful gains in brand awareness for the company and our products FINAPT and pomvori. We maintain strategic investments in our commercial infrastructure including increased brand visibility through targeted sponsorships with the goal of supporting long term market leadership and future commercial launches. Vanta's cash Cash equivalents and marketable securities referred to as cash as of September 30, 2025 was 293.8 million, representing a decrease of 80.9 million compared to December 31, 2024 and a decrease of 31.8 million compared to June 30, 2025. The change in cash during the third quarter of 2025 as compared to the second quarter of 2025 was driven by the net loss in the third quarter of 2025 as well as timing of cash received from customers for revenue and related payments of rebates to payers, as well as the timing of cash paid to third parties for services related to operating expenses. Turning now to our quarterly results, Total revenues were $56.3 million for the third quarter of 2025, an 18% increase compared to $47.7 million for the third quarter of 2024 and a 7% increase compared to $52.6 million in the second quarter of 2025. The increase as compared to the third quarter of 2024 was primarily due to growth in FANAPT revenue as a result of the bipolar commercial launch. The increase as compared to the second quarter of 2025 was due to both growth in FNAP revenue as a result of the bipolar launch and higher HETLIOS revenue Let me now break this down by product FNAP net Product sales were 31.2 million for the third quarter of 2025, a 31% increase compared to 23.9 million in the third quarter of 2024 and a 7% increase compared to 29.3 million in the second quarter of 2025. FNAP total prescriptions or TRX, as reported by Iquibia Exponent in the third quarter of 2025 increased by 35% compared to the third quarter of 2024 and 11% compared to the second quarter of 2025. FNAPS new patient starts in the third quarter of 2025, as reflected by new to brand prescriptions or NBRX, increased by 147% compared to the third quarter of 2024 and by 14% compared to the second quarter of 2025. The increase in FNAPPed revenue between the third quarter of 2025 and the third quarter of 2024 was primarily attributable to an increase in volume partially offset by a decrease in price net of deductions. The increase in FNAPPED revenue between the third quarter of 2025 and the second quarter of 2025 was attributable to an increase in volume and partially offset by a decrease in price net of deductions. These increases in volume were primarily driven by increased total prescription demand as well as increased wholesaler inventory levels. Historically, fnapped inventory at wholesalers has ranged between three and four weeks on hand as calculated based off trailing demand. As of the end of the third quarter of 2025, FANAPT inventory at wholesalers was just above four weeks on hand, which was consistent with the level of inventory weeks on hand as of the fourth quarter of 2024 but slightly above the historic range. Turning to Hetlios, Hetlios net product sales were 18 million for the third quarter of 2025, a 1% increase compared to 17.9 million in the third quarter of 2024 and an 11% increase compared to 16.2 million in the second quarter of 2025. The increase in net product sales relative to the third quarter of 2024 was primarily attributable to an increase in volume sold almost entirely offset by a decrease in price net of deductions. The increase in net product sales relative to the second quarter of 2025 was primarily attributable to an increase in price net of deductions, partially offset by a decrease in volume. Hetlios net product sales continue to be impacted by changes in inventory stocking at specialty pharmacy customers from period to period. Going forward, Hetlios net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, Hetlios net product sales may decline in future periods, potentially significantly related to continued generic competition in the U.S. additionally, the company constrained Hetlios net product sales for the first nine months of 2025 and and for the years ended December 31, 2024 and 2023 to an amount not probable of significant revenue reversal. As a result, Hetlios net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to inventory stocking by specialty pharmacy customers are resolved. And finally, turning to Pondvori Ponvori net product sales were 7 million for the third quarter of 2025, an increase of 20% compared to 5.9 million in the third quarter of 2024 and a decrease of 1% compared to 7.1 million in the second quarter of 2025. The increase in net product sales as compared to the third quarter of 2024 was attributable to an increase in volume. The decrease in net product sales as compared to the second quarter of 2025 was attributable to a decrease in volume sold almost entirely offset by an increase in price net of deductions. During the second quarter of 2025, there was an increase in net product sales as compared to the first quarter of 2025, which was attributable to an increase in volume sold, a portion of which was driven by increased underlying patient demand, albeit modest, but was also impacted by increased specialty pharmacy and specialty distributor inventory on hand levels above the historic range. The inventory on hand levels remained elevated as of the end of the third quarter of 2025 but had decreased closer to the historic range. As a reminder, we completed the acquisition of the US and Canadian rights to Pond Vori in December 2023 and initiated the commercial launch of PondVori in the third quarter of 2024. As such, this represents the fourth full quarter of Pondvori revenue recognition since the initiation of commercial launch activities and significant progress in diversifying our product mix with innovative and value generating products. Of note, an amount of variable consideration related to Pondvori net product sales and is subject to dispute, of which approximately 3 million was recognized for the three months ended December 31, 2024. For the third quarter of 2025, Vanda recorded a net loss of 22.6 million compared to a net loss of 5.3 million for the third quarter of 2024. From an income tax perspective, the net loss for the third quarter of 2025 included an income tax benefit of 5.8 million as compared to an income tax benefit which of 0.9 million for the third quarter of 2024. Of note on the tax side, the Company assesses the need for a valuation allowance against its deferred tax assets each quarter. Through the review of all available positive and negative evidence, the Company generated a pretax loss for the quarter ended September 30, 2025. If the company continues to generate pre tax losses and or if the Company's projections indicate pretax losses in in future periods or if there are meaningful changes to our business operations, the conclusion about the appropriateness of the valuation allowance could change in the future. An increase in the valuation allowance would result in a non cash income tax expense during the period of change. The current deferred tax assets reflected in the balance sheet as of September 30, 2025amount to 103.1 million. If it is determined that the Company needs a valuation allowance against its deferred tax assets in a future period, the non cash income tax expense recorded during the period of change could be equal to the significant majority of the $103.1 million balance. Operating expenses in the third quarter of 2025 were $87.5 million compared to $58.7 million in the third quarter of 2024. The $28.9 million increase was primarily driven by higher SGA expenses related to spending on Vanda's commercial products. As a result of the commercial launches of FNAPT in Bipolar Disorder and Ponvori in Multiple Sclerosis and higher R and D expenses during 2024 and 2025, we commenced a host of activities as a result of the commercial launches of FANAPT Bipolar Disorder and Pomborium Multiple Sclerosis, including expansions of our sales force and the development of prescriber awareness and comprehensive marketing programs during the first nine months of 2025. Our direct to consumer campaign launched in the first quarter continued to drive meaningful gains in brand awareness for the company and our products Fanapt and Ponvori. We maintain strategic investments in our commercial infrastructure including increased brand visibility through targeted sponsorships with the goal of supporting long term market leadership and future commercial launches. With regards to the launches of FANAPT Bipolar Disorder and Ponvorium Multiple sclerosis. As I mentioned, the launches were initiated in 2024 and we expect to continue the build out of our commercial infrastructure with the impact of these commercial efforts expected to contribute to revenue growth in 2025 and beyond. We have already seen significant growth in our commercial activities. Several lead indicators suggest a strong initial and continued market response to our commercial launch of FNAP for bipolar disorder, including new patient starts as reflected by NBRX increasing by 147% in the third quarter of 2025 as compared to the third quarter of 2024. In the third quarter of 2025 as compared to the third quarter of 2024, total prescriptions or TRX increased by approximately 35%. Of particular note, FANAPTT was one of the fastest growing atypical antipsychotics in the market through the first nine months of 2025. Based on several prescription metrics, our FNAP sales force size continues to expand. As of the end of the third quarter of 2024, our sales force numbered approximately 150 representatives and currently we have approximately 300 representatives. Following our additional expansion during the second quarter of 2025, these expansions have allowed us to significantly increase our reach and frequency with prescribers. To that end, face to face calls in the third quarter of 2025 were more than 20% higher than face to face calls in the second quarter of 2025 and face to face calls in the third quarter of 2025 Were more than twice the face to face calls in the third quarter of 2020. In addition to our FNAP sales force, we have established a specialty sales force to market pondvori to neurology prescribers around the country. We have grown this sales force to approximately 50 representatives in the third quarter of 2025. Of particular note, Ponvori underlying patient demand increased, albeit modestly for the second consecutive quarter. Before turning to our financial guidance, I would like to remind folks that with Fanapt, Hetlios and Pombori already commercially available and with Hetleos for jet lag currently being re reviewed by the FDA and the Trinipotent NDA for motion sickness under review by the fda, the Milsaperidone or hopefully to be known under the brand name Basanti NDA for Bipolar I disorder and schizophrenia under review by the FDA and a Biologics License application or BLA for Imsidolamom expected to be submitted later this year, vanda could have six products commercially available in 2026. Turning now to our financial guidance, Vanda is providing an update to its prior 2025 guidance. Vanda expects to achieve the following Financial Objectives In 2025 total revenues from Fanapt, Hetlios and Pombori of between 210 and 230 million. This compares to prior guidance of between 210 and 250 million year end 2025 cash of between 260 and and $290 million. This compares to prior Guidance of between $280 and $320 million. This revised revenue range narrowed to the lower end of the original revenue range, reflects strong FANAPT revenue growth in 2025, is expected to grow on a quarterly basis and potentially accelerate with the full impact of the expanded sales force. The revised and lowered year end 2025 cash guidance reflects the impact of the significant investments that Vanda is currently making to facilitate future revenue growth, both in the form of R and D investments and strategic investments in commercial infrastructure, including Vanda's Direct to Consumer campaign launched in the first quarter, which continued to drive meaningful gains in brand awareness for the company and its products as well as increased brand visibility through targeted sponsorships with the goal of supporting long term market leadership and future commercial launches. With that, I'll now turn the call back to Mihalis.

Thank you very much Kevin. At this point we would be happy to answer your question.

We will now begin the question and answer session. If you would like to ask a question at this time, simply press STAR followed by the number one on your telephone keypad and your first question comes from the line of Braggram Salvaradu with HE Wainwright Program. Please go ahead.

Thanks very much for taking my questions. I was wondering if you could pro first and foremost comment on some hypothetical scenarios with respect to the interactions with the FDA and if these ultimately result in approval decisions, particularly as this pertains to tridipitant when those approvals might occur. Should we expect potential the possibility of tradipotent approval sometime in the first half of 2026 if ultimately the interactions with the FDA proceed positively?

Yes. Thank you very much Ram. First of all I would say and reiterate that we're very pleased with a new collaborative framework that has been established with the FDA and just as a background that comes after the significant development of a win in the appellate court by Vanda in August of this year where we challenged the decision of rejection of headers for jet lag without a hearing and the court canceled the rejection by the FDA and and send it back to the FDA for further proceedings. This was one of the precipitating factors alongside with the new management at the FDA where we sat down with them to develop a path forward and were very quickly able to agree on several initial steps. And the first one, as we mentioned, is the review of the Hetlius SNDA for jet lag and a promise to be completed by early January of 2026. On your question on trade dividend, trade dividend review is ongoing and we expect the decision by December 30, 2026. The reason we are optimistic is that so far there have been no issues raised with the efficacy of the drug and therefore we are encouraged that this could lead to approval. One area that's very relevant with the collaborative framework to Tradipitant is the reconsideration of the partial clinical hold. And to give context, this is a clinical hold on a longer term motion sickness study. The initial study lasted 12 months and people could take up to 90 doses. We asked for an extension of that study with an amendment to further study tradipitant for an additional 12 months and an additional 90 dose within that period. And that is when about a year ago or so the FDA objected to that additional extension suggesting that an additional long term six month dog toxicity study is needed. And of course we have contested that. But now the FDA was willing to reconsider that decision and that is now with CIDR with a promise to issue a decision by end of November. So with that if cleared alongside what is almost agreed upon, I would say efficacy demonstrated for adipotent motion sickness would be optimistic for an approval by end of this year.

Okay, thanks, that's very helpful. Secondly, I wanted to ask about Ponvori performance and what you look for in terms of future quarterly growth rate pickup in revenue from this product, particularly given the current investment that you're making in in sales and marketing behind the product at this point. Maybe you can give us a sense of what kind of quarterly growth you would expect in terms of net sales for Pondvori over the course of the next two, three quarters. That would be helpful, thank you.

Yeah. I will let Kevin comment on the future growth, but I would say we're still in the early phase. The salesforce that was built to about 50 people is actually a very recent event in the last quarter or so. Fully staffed, the speaker programs are just starting and Ponvori has been a smaller piece of our direct to consumer campaign so far. That being said, these are significant investments and we're investing towards future growth. But I will pass it on to Kevin for a comment.

Thanks Moss. And thanks, Ram, for the question. Just as a bit of reminder on the background here. So we acquired the product from J&J at the end of 2023, and at that point J and J had ceased support for the product a little over a year prior to that. We completed the transition of the Pombori product from J&J right at the end of the third quarter of last year. So, you know, about a year ago. And what we saw during that period from when J&J ceased commercial support through the first quarter of this year was a decline in the underlying patient demand. And that would be expected given that there wasn't any active support support in the market from essentially the end of 2022 through roughly the end of the third quarter of last year. What we've seen in the last two quarters that's very encouraging to us is we've seen increases in the underlying patient demand Both from the first quarter to the second quarter and then again from the second quarter to the third quarter. There's been some buying patterns from the SPs and SDs that have made the quarterly revenue a little bit up or a little bit down, depending on the timing of their purchases, but the underlying demand during those two periods is up. And so for us, that's an encouraging sign that our commercial strategy and support for the product is beginning to take hold. And as Mihalis mentioned, with the recent investment in the commercial sales force that, as I mentioned in my script, was completed during the third quarter of this year, we're hopeful that we'll begin to see that trend continue. Continue and potentially increase as we exit this year and head into next year where we not yet have provided guidance beyond 2025.

Okay. And then just very quickly, two other timeline aspects. I was wondering if you could a comment on the prospectus for the Incidolumab BLA to receive priority review once it has been submitted to the fda. And secondly, if you could give us any sense of whether you have revised or more specific timing guidance to provide on the MDD study. Thank you. So, Rahm, I think your two questions were on the imsidolumab priority review.

Yeah, I will address that, but go ahead, Kevin. And then on the timing for the MDD study, Rahm, so maybe I'll take that one second. Is what we've communicated at this point is that the expansion results by the end of next year. But given that we've, you know, enrolled patients, you know, over the last few quarters, we'd like to see a bit more of kind of a run rate before we provide an Exact timing, you know, on what, you know, period. We expect to see the results in but at this point we've communicated results by the end next year and hope to be able to share more as we get a few more quarters under our belt.

Yeah, that's right. And sites are coming up in in the US but also very recently we got approval for initiation for a number of sites in Europe. So hopefully that will accelerate recruitment. Regarding IMC Dolimab, of course, this is a rare orphan disorder and we expect a six month priority review.

Thank you.

Thanks Ram. And your next question comes from the line of Olivia Breyer with Cantor. Olivia, please go ahead.

Hey, good afternoon guys. Thank you for the questions. Can you talk a little bit about the guidance change this quarter? I mean at the midpoint it still implies growth for 4Q but at the lower end of the range, you know, it wouldn't necessarily. So maybe just thoughts around the pushes and pulls of that guidance change and what you're seeing so far into October. That helped informs today update. That helped inform today's update. And then I've got a couple questions on Vasanti.

Yep, absolutely. Thanks Olivia for the question. So a couple pieces there and one thing that I commented on in my script was that underlying the guidance for this year is strong FNAF revenue growth for the year. Right. Which is I think an underpinning of our guidance. But the other thing that's a variable in that consideration is the Hetlios revenue which we've commented on can be very variable from quarter to quarter depending on the timing of our customers purchases. So what we see there is that the actual underlying demand for Hetlios is pretty consistent. As we've mentioned, we maintained the majority of the market share still at this point, even two and a half years post generic launch. But the actual buying patterns which translate to the revenue patterns for Hetlios can vary from quarter to quarter. And if we saw customers not need to buy as much in the fourth quarter, that could put us on the lower end of the revenue range. So that's kind of the dynamic there. But for fanapt, what we've seen the last two quarters is both revenue meaningful growth in both quarters and the underlying demand which we're highly focused on right from a quarter to quarter perspective growing sequentially very strong. So we saw 14% growth Q1 to Q2 and 11% growth Q2 to Q3 from a script perspective. And so we expect to see that continue to grow and Q4 to increase relative to Q3 would be our expectation underlying that guidance.

Okay, got it. Super helpful, Kevin. Thank you. And then is there anything you guys can tell us at this point around just the engagement that you're having with the FDA for your ongoing Basanti review? Have they indicated wanting to see any additional information as part of your submission package? And anything you can tell us on when you might enter into the label discussions for that asset? And then just kind of as a. I know that's a couple questions in there, but as a follow up on the commercial side, as you look out to your PDUFA next year, what's the commercial strategy for actually convincing patients to switch from Fanapt over to this newer product? Is there a commercial hook or an incentive that would actually incentivize patients to make the switch before a generic version of Fanapt becomes available?

Maybe I start off with the regulatory update and let Kevin comment on the commercial strategy. I think we have given an update that so far the interactions with the division have been quite positive in that there have been no issues raised on the efficacy and safety of the drug. So that is progressing well. Now, in terms of label negotiations, we don't comment if they have started or about to start, but typically those will precede the PDUFA date by a couple of months or so.

Yep. And then, Olivia, on the commercial strategy, you know, we haven't shared, I would say, you know, some key elements of our commercial strategy for, you know, Basanti and the potential transition for FNAP to Basanti. But what I would tell you is, as we've talked about in the past, the atypical antipsychotic class is both a highly promotionally sensitive class and also a high switch class. So products that are actively promoted out there, as you know, will do significantly better than products that are not actively promoted. And as part of that, with it being a high switch class, if there are certain commercial tools that are available to prescribers, namely starter packs or titration packs in our case, or commercial copay programs, if those programs are available to patients that are starting, they'd be more likely to start on a product that offers those programs versus a product that doesn't. So I think both the nature of the class being highly promotionally sensitive and the potential support that could be available for patients, I think will lead to meaningful success on Basanti when we decide to pull that trigger.

And I will add, Olivia, that the longer commercial plan is the addition of indications, starting with the adjunct treatment of major depression, with actually a key differentiator of how FNAP has been used so far with a once a day dosing, increasing the convenience and hopefully compliance.

Okay, thank you both, appreciate it.

Thanks Olivia. And your next question comes from the line of Andrew Tsai with Jefferies. Andrew, please go ahead.

Hey, good afternoon and congrats on the quarter. This is Matt Barkus on for Andrew Tai. First off, for tripotent and motion sickness, it could be approved on December 30th and then Hetlios jet lag could be approved January 7th. What would your marketing strategy be for these and what would the shape of the launch curve look like for these drugs?

Yeah, thank you. We're actually very excited for both of these potential approvals because they share in common the consumer centric focus both in heterogeneous and jet lag and trudipiden for motion sickness. We're developing a quite elaborate strategy that will become very consumer centric, focusing on concierge service for supplying the drug to both of them. And our recent experiences with direct to consumer campaigns, but also the elevation of brand awareness of the company are going to be very important and have been strategically designed to be in place in advance of those launches. We expect if both of them approved in that timeframe. You mentioned that we should be able to be in the market by the first half of 2026. And in subsequent introductions we can discuss a little more about the latest on the total addressable market for both indications. But I will highlight it is significant and expanded both of increased travel, but also the unmet need in motion sickness that has not seen a new treatment in the last 45 years.

Great. And then for your GLP vomiting study, can you describe that study like what does the positive efficacy data look like and what would be the next steps for the program? And then similarly for Basanti should have like phase three data in 2026. What kind of measures efficacy separation do you hope to achieve in that study?

Yeah, so I will start with a last question on mdd, like any other study, there is not a threshold of response. We are looking for a positive primary endpoint on the typical clinical scales that will be used. And of course, you know, subsequently people are doing respondent analysis trying to identify portion of patients responding to a certain effect. But there is no threshold that is required. But of course the study is powered to detect a significant minimal threshold of efficacy. Your other question was on the use of TraTradipitant in preventing the GI specifically vomiting side effects of WeGovy semaglutide. And we know that GLP1 analogs have to be titrated slowly because of the very frequent nausea and vomiting side effects, which actually limits the efficacy, at least for a certain period of time. And for a number of patients, around 15% or so may actually drop out of treatment and never see the benefit of GLP1 analogs. So this is a well understood and very significant therapeutic issue. The study we've designed administers Tradipitant for a few days prior to initiating a wegovy injection which is administered at much higher dose than the recommended titration dose. Titration dose begins at 0.25 milligrams and escalates in four week increments. The dose we're used in the study is 1 milligram and patients are randomized to receive either wegovy or placebo. And what we do is we follow these people and measure the efficacy with the number of vomiting episodes and other secondary endpoints like nausea, duration of nausea, et cetera. And as I said, this study has completed now. The sites and data are being monitored and data cleaned and we hope soon to be able to analyze the top line results.

Understood, thanks.

That concludes our question and answer session. I will now turn the call back over to Fanta Management for closing remarks.

Thank you very much for joining this call. We'll see you at a later time.

This concludes today's call. You may now disconnect.