Operator
Ladies and gentlemen, welcome to the Q3-2026 Vanda Pharmaceuticals, Inc. earnings call. All lines have been placed on mute to prevent any background noise, and after the speaker's remarks, we will conduct a question and answer session. If you'd like to ask a question at that time, please press star, then the number one on your telephone keypad to raise your hand and enter the queue. If you'd like to withdraw your question at any time, please press star one again. I'll now turn the call over to Vanda Chief Financial Officer, Kevin Moran.
Thanks, Colby. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's third quarter 2026 performance. Our third quarter 2026 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. Mahalas Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Daniel McGuire, our General Counsel. Following my introductory remarks, Mahalas 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 10-K, as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K, and other filing statements. with the SEC, which are available on the SEC's EGDR 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. Mahalas Polymeropoulos.
Thank you, Kevin. Good afternoon, everyone. Thank you for joining us today for Vanda Pharmaceuticals' third quarter, 2026 earnings conference call. We're pleased with the strong revenue growth in the third quarter, increasing 24% year over year, driven by continued FANAP momentum and the early contribution from our nearest commercial launch, While operating expenses decreased 18% compared to the second quarter, as key Phase III and launch preparation activities conclude. Looking ahead with the commercial launch of Bisanti expected in fourth quarter, the Quimilza BLA under-FTA review with a December PDUFA date and positive Phase III results supporting potential expansors for Nereus in GLP-1-induced vomiting and Hetlius in delayed sleep-wake phase disorder were focused on further moderating costs and driving revenue growth from our current portfolio. Some of our financial highlights on operating expenses. During 2025 and 2026, we have advanced multiple Phase III programs, continued our commercial activities for FNAPT, Hetlius, and Ponvori, and prepared for the commercial launches, including manufacturing, commercial supplies of Nereus, Visanti and Quimilza. These activities resulted in significantly increased operating expenses in 2025 and 2026. As certain of these activities began concluding in the third quarter of 2026, operating expenses have decreased, and we expect operating expenses to decrease further in future quarters. As the remainder of these activities conclude. Some key commercial highlights. FNAPT saw a continued strong momentum in Q3-2026, with total prescriptions, TRX, up 25%, and new-to-brand prescriptions, NDRX, up 18%, versus Q3-2025. Since commercial expansion following the approval of bipolar disorder, FNATI has seen significant growth with TRX up 72% and NBRX up 306% versus the second quarter of 2024. Bisanti received FDA approval for the treatment of bipolar 1 disorder and schizophrenia in the first quarter of this year, 2026, and is expected to launch in the fourth quarter of 2026. Besanti is protected by data exclusivity through February 20, 2031, and multiple patents, the latest of which expires on May 31, 2044. NIRUS was launched commercially in the U.S. in the second quarter of 2026 with a direct-to-consumer offering via the web portal nirus.us. Salesforce promotion began in the third quarter of 2026. During the third quarter of 2026, the nearest launch showed strong growth in both total prescriptions and unique prescribers as compared to the second quarter of 2026. Key regulatory and clinical developments. Recent and upcoming milestones. In October 2026, we announced positive results from the Phase III clinical study, VPVLY-686-3601, of Nureus for the prevention of vomiting associated with GLP-1 receptor agonist therapy. We intend to discuss the results with the FDA and plan to submit a supplemental new drug application, SNDA, seeking approval of Nureus for the prevention of vomiting associated with GLP-1 receptor agonist therapy. In September of 2026, we announced positive top-line results from the pivotal Phase III study of Hetlius in adults with delayed sleep-wake phase disorder. We intend to discuss this data with the FDA and to submit a supplemental NDA seeking approval of Hetlius for DSW-PD. If approved, Hetlius would be the first FDA-approved medicine indicated for this condition. The Biologics License Application, BLA, for Quimilza in Generalized Post-Sorps Psoriasis, or GPP, is under review by the FDA with a prescription drug user, FIAC, PIDUFA, target, action date of December 12, 2026. The results of the Pivotal clinical study were published in the April 28, 2026 issue of the New Gland Journal of Medicine Evidence. The Phase III study of DeSanti as a once-daily adjunctive treatment for major depressive disorder, MDD, is ongoing, with results expected in the first half of 2027. The study is enrolling patients in 54 sites in the U.S. and Europe and has enrolled 55% of the 500-patient enrollment target. The primary endpoint of the study is the change from baseline to week 6 of the Montgomery Asperg Depression Rate and Scale, MADRAS, comparing milciperidin placebo. Secondary endpoints include Clinical Global Impression Severity, CGIS, and Clinical Global Impression Change, CGIC. Finally, on ongoing regulatory proceedings, we continue to progress the FDA formal hearing regarding HATLIOS for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the disease circuit set aside the FDA's Refusal to approve the application is advancing, according to schedule, and is expected to culminate in a five-day hearing before the administrative law judge from December 14, 2026 to December 18, 2026. We continue to pursue a legal challenge to the FDA's final order refusing to hold the hearing or to approve our SNDA for head use in the treatment of insomnia. Following oral argument before the U.S. Court of Appeals for the DC Circuit in September 2026, the matter is awaiting decision. We continue to pursue our challenge to the FDA's final order refusing to hold a hearing or to approve the company's NDA for near use in gastroparesis. Briefing is currently underway before the DC Circuit and is due to be completed in mid-November. With that, I'll turn now to Kevin to discuss our financial results. Kevin.
Thank you, Malz. I'll begin by summarizing our financial results for the first nine months of 2026 before turning to discuss the third quarter of 2026. Total revenues for the first nine months of 2026 were $172.1 million, an 8% increase compared to $158.9 million for the same period in 2025. The first nine months of 2026 included increased FNAPT revenue as a result of the continued commercialization efforts for FNAPT and Bipolar I disorder, increased Ponvori revenue, and revenue contribution from the newly launched Nereus, partially offset by decreased Hetlios revenue as a result of generic competition. Let me break this now by product. FNAP net product sales were $104.3 million for the first nine months of 2026, a 24% increase compared to $84.1 million in the same period in 2025. The increase to net product sales relative to the first nine months of 2025 was attributable to an increase in volume. Turning to Hetlios. Hetlios net product sales were $43.2 million for the first nine months of 2026, A 21% decrease compared to $55 million for the same period in 2025. The decrease was attributable to a decrease in volume as a result of continued generic competition in the U.S. Of note, for the third quarter of 2026, Hetlios continued to be the leading product from a market share perspective, despite generic competition now for nearly four years. Turning next to Ponvori. Ponvori net product sales were $21.9 million for the first nine months of 2026, an 11% increase compared to $19.8 million for the same period in 2025. Of note, an amount of variable consideration related to Ponvori net product sales is subject to dispute, of which approximately $3 million was recognized for the three months ended December 31, 2024. And finally, turning to Neerius. Neerius net product sales were $2.6 million for the first nine months of 2026. As a reminder, Nereus launched commercially in the U.S. in May, 2026, with the direct-to-consumer offering via the web portal, Nereus.us. Salesforce promotion using our existing Salesforce commenced during the third quarter of 2026. For the first nine months of 2026, Vanda recorded a net loss of $133.6 million, compared to a net loss of $79.3 for the same period in 2025. The net loss for the first nine months of 2026 included income tax expense of $0.4 million as compared to an income tax benefit of $21.4 million for the same period in 2025. As a reminder, the company recorded a one-time non-cash income tax charge in the fourth quarter of 2025 to establish a valuation allowance against all of Vanda's deferred tax assets. Tax expense is expected to be nominal going forward until such time that a valuation allowance is no longer required. Operating expenses for the first nine months of 2026 were $309.6 million, compared to $269.7 million for the same period in 2025. The $39.9 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the continued commercialization efforts for FNAF and Bipolar I disorder, the Nereus commercial launch, and the upcoming Bisanti commercial launch, And higher R&D expenses primarily related to our VQW, Basanti, and various other development programs, partially offset by lower expenses on our Quimilza, or Imsidolimab program. The first nine months of 2025 included an upfront payment to Enaptis for the exclusive global license agreement for the development and commercialization of Quimilza. On the commercial side, starting in 2024, we commenced a host of activities as a result of the commercial launches of FNAPT and Bipolar I Disorder and Ponvori and Multiple Sclerosis, and, more recently, the launch of Nereus and upcoming launch of Bisanti. 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. The end of cash, cash equivalents, and marketable securities, referred to as cash as of September 30, 2026, was $140.5 million, representing a decrease of $123.4 million compared to December 31, 2025, and a decrease of $29.5 million compared to June 30, 2026. The change in cash during the third quarter of 2026, as compared to the second quarter of 2026, was driven by the net loss in the third quarter of 2026, excluding the impact of non-cash charges, such as stock-based compensation and amortization of our intangible and right-of-use assets, as well as timing of cash received from customers for revenue and related payments of rebates to payers, and the timing of cash paid to third parties for services related to operating expenses and inventory production. The decrease as compared to the balance as of December 31, 2025, was also driven by the one-time milestone payment of $10 million made to Eli Lilly in the first quarter of 2026 for the approval of Nereus in the U.S. As a reminder, payments made in advance of production are capitalized as prepaid expense. Commercial products are capitalized as inventory on our balance sheet after production, while pre-commercial products are generally expensed as incurred as research and development costs. The timing of production of pre-commercial products, including the Cui Milza program, may result in future variability of our R&D expense and cash payments. Turning now to our quarterly results. Total revenues were $69.8 million for the third quarter of 2026, a 24% increase compared to $56.3 million for the third quarter of 2025, and a 38% increase compared to $50.5 million in the second quarter of 2026. The increases as compared to the third quarter of 2025 and the second quarter of 2026 were primarily due to an increase in Hetliost revenue as a result of the timing of purchases by specialty pharmacy customers during the year, the timing of shipments to customers at the end of the second quarter of 2026, and growth in FNAP revenue as a result of the Bipolar I commercial launch. Let me break this down now by product. FNAP net product sales were $38.8 million for the third quarter of 2026, a 24% increase compared to $31.2 million in the third quarter of 2025, and an 8% increase compared to $36 million in the second quarter of 2026. The increases to net product sales relative to the third quarter of 2025 and second quarter of 2026 were primarily attributable to increases in FNAPT total prescriptions, or TRX, as reported by Equivia Exponent in the third quarter of 2026 increased by 25% compared to the third quarter of 2025 and 6% compared to the second quarter of 2026. Historically, FNAPT 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 2026, FNAPT inventory at wholesalers was slightly below four weeks on hand, which was lower than the level of inventory weeks on hand as of the second quarter of 2026 and the fourth quarter of 2025, but generally consistent with the historic range. Turning to Hetlios. Hetlios net product sales were 21.7 million for the third quarter of 2026, a 21% increase compared to 18 million in the third quarter of 2025, and a 289% increase compared to 5.6 million in the second quarter of 2026. The increase in net product sales relative to the third quarter of 2025 and the second quarter of 2026 was primarily attributable to an increase in volume due to the timing of purchases by specialty pharmacy customers during the year and shipments to customers at the end of the second quarter of 2026. Hetlio's net product sales in the third quarter of 2026 includes orders totaling approximately $7 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders were recognized as revenue in the third quarter of 2026. Hetlios net product sales continue to be impacted by changes in inventory stocking at specialty pharmacy customers from period to period. During the third quarter of 2026, there was stocking of inventory by certain of our specialty pharmacy customers. 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, Hetlio's net product sales may decline in future periods, potentially significantly, related to continued generic competition in the U.S. Turning to Ponvori, Ponvori net product sales were $7.7 million for the third quarter of 2026, an increase of 10% compared to $7 million in the third quarter of 2025, and a decrease of 2% compared to $7.9 million in the second quarter of 2026. The specialty distributor and specialty pharmacy inventory on hand levels during these periods We're in line with normal ranges. Additionally, as we have previously discussed, an amount of variable consideration related upon VORI net product sales is subject to dispute, of which approximately 3 million was recognized for the three-month end of December 31st, 2024. And finally, turning to Nereus. Nereus net product sales were 1.6 million for the third quarter of 2026, an increase of 60% compared to 1 million in the second quarter of 2026. As previously mentioned, Nereus launched Nereus is sold using both the traditional wholesaler channel and also directly through the Nereus.us website. Revenue recognized during the third quarter of 2026 primarily related to units sold through the wholesaler channel. During the second quarter of 2026, there was an initial For the third quarter of 2026, Vander recorded a net loss of $22.6 million, compared to a net loss of $22.6 million for the third quarter of 2025, And compared to a net loss of $62.5 million for the second quarter of 2026, the significant improvement of nearly $40 million in net loss between the second and third quarters of 2026 is primarily the result of an increase in total revenues of $19.3 million combined with a decrease in total operating expenses of $21 million. The net loss for the third quarter of 2026 includes income tax expense of $0.2 million as compared to an income tax benefit of $5.8 million for the Thank you. SG&A expenses, including higher spending on Vanna's commercial products, offset by lower legal expenses. The $21 million decrease between the second and third quarter of 2026 was primarily driven by lower R&D expenses, primarily related to our VQW 765, Nereus, FNAPT, and other development programs, and lower SG&A expenses related to spending on Vanna's commercial products and lower legal expenses. With regards to the launches of FNAPT and Bipolar I disorder and As I've mentioned, the launches were initiated in 2024, and we continue to enhance our commercial infrastructure through the third quarter of 2026, with the impact of these commercial efforts contributing to revenue growth for these products in 2026 and expected to continue to contribute revenue growth for these products in coming periods. We have already seen significant growth in our commercial activities. Several lead indicators suggest a strong and continued market response to our commercial activities related to FNAF for bipolar I disorder, including total prescriptions, or TRXs, increased by approximately 25% in the third quarter of 2026 as compared to the third quarter of 2025. In September of 2026, weekly TRXs for FNAF reached an 11-year high of nearly 2,800 prescriptions for the week ending September 25, 2026. New patient starts, as reflected by NBRX, increased by 18% in the third quarter of 2026, as compared to the third quarter of 2025. And since the commercial expansion following the approval of bipolar I disorder, Phenapt has seen significant growth, with TRX up over 70% and NBRX up over 300%, as compared to the second quarter of 2024. Of particular note, FNAPT was one of the fastest-growing branded atypical antipsychotics in the market throughout 2025 and into the third quarter of 2026 based on several prescription metrics. Our FNAPT sales force expanded to approximately 300 representatives in the second half of 2025. This expansion has allowed us to significantly increase our reach and frequency with prescribers. To that end, the number of face-to-face calls in the first nine months of 2026 were 35% higher than the number of face-to-face calls in the first nine months of 2025. FNAP performance remains the focus of Vanda's commercial initiatives and encourages us to continue to invest in this differentiated medicine and the franchise-extending launch of Basanti, expected in the fourth quarter of 2026. Before turning to our financial guidance, I would like to remind folks that with FNAP, Tetlios, Ponvori, and now Nereus already commercially available, and with Basanti recently approved for bipolar 1 disorder and schizophrenia, and a biologics license application, or BLA, for Quimilza, now under review by the FDA, Vanda could have six approved products by the end of this year. Turning now to our financial guidance. Vanda is updating its full year 2026 total revenue guidance and expects to achieve the following financial objectives in 2026. Total revenues from FNAPT, Basanti, Hetlios, Ponvori, and Nereus of greater than $240 million. Additionally, note that Nereus launched commercially in the U.S. in May of 2026 with the direct-to-consumer offering via the web We are at the very beginning of the commercial launch of Nereus in a consumer market with a broad base of prescribers. While we believe the Nereus opportunity in motion sickness As previously communicated, Vanda is not providing 2026 cash guidance at this time. However, it is likely that Vanda's 2026 cash burn will be greater than the cash burn in 2025. During 2025 and 2026, we have advanced multiple Phase III programs, continued execution on the commercialization of Phenapt and Pombori, and prepared for the commercial launches, including manufacturing commercial supplies, of Nereus, Basanti, and Quimilza. These activities resulted in significantly increased operating expenses in 2025 and 2026. As certain of these activities began concluding in the third quarter of 2026, operating expenses have decreased by 18% to $93.3 million from $114.3 million in Q2 of 2026. Vanda expects operating expenses to decrease further in future quarterly periods as the remainder of these activities conclude. With that, I'll now turn the call back to Mahalas.
Thank you very much, Kevin. At this point, we'll be happy to answer your questions.
Operator
Thank you. We will now begin the question and answer session. Again, if you would like to ask a question, please press star, then the number one on your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question at any time, simply press star one again. Our first question comes from Ram Selfaraju with H.C. Rainwright & Co. Your line is open. Ram, your line is open.
Thanks so much for taking my questions. I just wanted to ask in particular about how quickly you expect QMILSA launch to be effected, assuming timely approval on December 12th. Also, I wanted to check in to see what the status is with progress on the Bisanti MDD Clinical Development Pivotal Program, as well as if you can offer us any additional updates regarding the iloperidone LAI program. Thank you.
Yeah, thank you. Thank you, Ram. On Quimilza launch preparation, we are working very hard on manufacturing commercial supplies as we speak in anticipation of good results by the FDA on December 12th. That means that we could be ready with commercial product a few months after December. It's hard at this time to exactly estimate, but certainly our goal in preparation is to be on the market in the first half of 2027. Your second question was on a progress on MDD. In that, the study has been enrolling now for about 18 months in over 50 sites in the U.S. and Europe, and more than 50 percent of the study is now enrolled. And to remind you, the enrollment target is 500 patients. We've seen enrollment vary from month to month, but we're confident with additional sites, we'll be able to meet our enrollment goals, which is to complete in the first half of 2027. The third question was alloperidon LAI. As we have discussed previously, recruitment in that program was extremely slow, and also a discovery that in this placebo-controlled relapse prevention study, the relapse rates were extremely small, something that has been recently observed in other studies. Similar clinical programs, which let us reconsider the direction of that program, and we're considering potentially a PK bridging proposal to the FDA to be able to bring the program forward using existing PK data, both in oral and in the long-acting injectable. This is developing, and we're going to have more of that in the future.
Can you just clarify what factors at this juncture that are known, if any, might impact whether or not ultimately the SNDA for tradipotant in prevention of GLP-1 receptor agonist-associated nausea and vomiting could be accorded priority review? Thank you.
Yeah, it's hard to gauge into, you know, the FDA's priority review. What is, I would say, a positive is that this is a large unmet medical need. And we see very significant effect sizes, as we reported a couple of days ago, that in the most severe cases that people who vomited more than 10 times in the week following the injection, the reduction in that risk rate was by 80 percent. So, highly meaningful, and it would be the first adjunctive treatment for a very significant and met medical need in a large category that affects millions of Americans, but it's hard to speculate on priority review. In terms of next steps, first things first, we'll be preparing for supplemental NDA, including We have a meeting with the FDA to make sure we have a package that would be acceptable.
Operator
Your next question comes from the line of Les Solueski with Oppenheimer & Co. Your line is open.
Thank you for taking my questions, and congrats on the progress. Just a few from me here on the Finapt. New-to-brand prescriptions were up 18% versus, I believe, 32 in 2Q. Any sort of read-through from the strong second quarter? On Bisanti, the commercial supply is expected in 3Q and now launch is in 4Q. What was the hold-up on that, and is there any product in the channel today? And then just to go back to nearest, not that the Salesforce promotion has started, what are you seeing on the refill rates and pills per fill data? And then separately, on the GLP-1 front, in Phase 3, you reported the vomiting cut by 27% versus roughly half in Phase 2. I guess, what explains that gap? And will the supplementary NDA filing rest on the primary endpoint or the post hoc extreme vomiting data? Thank you. Fantastic.
I'm trying to remember all the questions. So, I will start with the last one on the news. You're correct to observe that in the primary endpoint, which was any vomiting, any single episode of vomiting in the week after the semaglutide injection counted as vomiting. That is the same primary endpoint that we had in the prior study. And the relative rate of reduction was 27% in this study and 50% in the smaller phase 2 study. And we believe that is due to variability, both with sites and patients in a larger study. And it is a phenomenon that you may be quite familiar with that phase two studies that are positive usually find their way into phase three. And therefore, there is a very well understood migration to the mean. In the detail behind that, though, you may have noticed that the placebo rates for the phase 3 and phase 2 study were almost identical at 58%. So what actually differed was the rate in phase 2 study for drug was 29% versus 42-43% in the phase 3. And this is something that motivated us to try to understand more the stability of this number. And as we sought to explore what happens in severe cases, you see actually the change to narrow between the Phase 2 and the Phase 3 study. And for the extreme vomiters, people with more than 10 vomiting episodes in the week following semaglutide injection, we saw almost identical rates between the phase 3, 81%, and phase 2, 83%. So we believe that the 27% and 50% is an instability of the effect due to site and patient variability, but nonetheless, the result remains very robust and reproducible. And I think you asked about the filing. Yes, the primary endpoint is the declared primary endpoint, and we will be supporting it with a phase two study. We're supporting it with the pooled analysis, but also the key secondary endpoint, which also succeeded, which was rate of vomiting in people with At the same time, severe nausea of greater or equal to three in a five-point scale. And there, again, the results confirmed the Phase II findings. Kevin, what was the other question?
Yeah, so on the NBRX side, back to the first one there, Les, so you're right that we did see a lower rate of NBRX growth in the third quarter relative to the rate that we saw in the second quarter, Which is to be expected as you, you know, continue to go on that the growth rates themselves will be smaller because it's off of a larger base, right? But the encouraging part there is that we continue to see strong NBRX growth, you know, year over year and very strong receptivity in the market to our reps and the FNAP product being, you know, added to prescribers and brought to new patients. And also provides a nice bridge for us as we, and to segue to your next question, look to launch Basanti by the end of the year. Timing there? I'll turn to Mahalos for a quick update on that.
Yeah. The timing depends, actually, on completion of our commercial manufacturing supplies. We have about 10 different strengths, which is a lot of work. They're almost ready to go. We're very hopeful that we're going to be out in the market, as we said, in Q4, and hopefully Before the end of Q4. But everything is being manufactured and will be ready to go, finishing the last touches.
And then, Les, I think the last one was around what we've seen on refill and quantity fill on Nereus. And as you can imagine, you know, early in the launch here, we're seeing, you know, variability of you see some fills with a small number of pills, some fills with almost a full bottle of fills, right? And so still seeing kind of, you know, variability across the space there and starting to see refills. Again, it's been a short period of time, relatively speaking, but we've seen refills coming through as well. So small numbers early in the launch, but both are encouraging in terms of the activity.
And it may be worth adding that through Neutrius.us, we also have a direct line with patients, and they can actually comment on their experiences. And they have been enthusiastic of life change and experiences based on the effects of Neutrius. So we're very encouraged by that. And what we're learning during this very early stage of the launch is that the product is very promotionally sensitive. We see that by pulsing commercial ads and seeing the receptivity and, in fact, orders in the news.us being in close time in proximity. So what we're trying to understand and optimize is the level of promotional awareness support and then, in turn, on investment. But all early signs are encouraging, both in that channel and the retail channel, which is more of organic growth. Just to underscore a little bit about the prescriber base, in the retail channel, we can actually characterize who are the prescribers. And by specialty, the vast majority are in primary care, which would be expected for this indication. And then there is a spattering of other specialties, including neurology, psychiatry, gastroenterology, and ENT, which actually underscores something very significant about the commercial launch, that consumer awareness is the driving factor, while this large and distributed number of specialties of prescribers is not going to be something undressable with a regular sales force tactic.
Very helpful. Thank you both.
Operator
Your next question comes from the line of Madison L. Suddy with B. Reilly Securities. Your line is open.
Hi. Congrats on the progress, and thanks for taking our question. A couple from us. One's a bit of a follow-up. Do you expect the GLP-1 label to restrict NARIAs to the titration phase or permit more of a chronic dosing throughout maintenance? And I'm really just curious, you know, is it possible that the SNDA positioning Narius to support starting at the target GLP-1 dose versus at the titration dose? Secondly, if you could give a sense of the user profile of those patients that are currently using Narius. I know it's very early in the launch, but just curious what these patients look like, if it's one particular segment, and then afterwards a follow-up, please. Thanks.
Yeah, yeah. Thank you, Madison. So, a bit on the how we envision Nereus in a GLT-1 prevention of vomiting label. So, what we have studied is the acute administration of Nereus A few days prior to a semaglutide injection in an otherwise naive candidate patient, and then follow on with an additional seven days of administration post-injection. So this data, we believe, supports the prevention of vomiting induced by GLP-1 period. How we envision is to be used has to do with the natural history of the GI tolerability. As you may know, the vast majority of GI complaints with GLP-1 agonists is around the injection period, and that is right after the injection period and the peak of concentration. And then the GI tolerability improves and symptoms dissipate. We have now, in these two controlled studies, for the first time to our knowledge, we have exactly timed that tolerability issue. And I think we gave a glimpse of that in our press release, where we characterized that the majority of vomiting episodes occur on days one and two. So that beyond day three, placebo has a minimal number of episodes as well as drug deaths, which would actually confirm and suggest that the GI tolerability issues are short-lived after an injection. Now, there is a different open question which we think we have the answer, which is, we used a highly hematogenic challenge of 1 mg subcutaneous to ensure a large number of open episodes so we can actually be able to see the effect of the drug. This is a method that has been effectively used in other similar programs with highly Heliometrogenic chemotherapeutics, as you're aware. So, the question is, how does the drug work at 0.5 milligrams or even at the starting dose of 0.25 milligrams of semaglutide? And two answers there. The logical answer is that if a drug overcomes a bigger challenge, it should overcome a lower challenge. In this study, though, we were able to answer the question by observation as well. So what we, again, gave a glimpse at the press release was that an exploration of pharmacokinetic relationship between semaglutide levels and drug response supports that the drug will We'll have a significant relative risk reduction effect from placebo at lower doses as well. And the reason we say that is because the natural spread of semaclutide blood concentrations after administration of one milligram allowed us the opportunity to build a PK-PD, pharmacokinetic, pharmacokinetic, We're actually, we see the level of reduction at low exposures and higher exposures to be approximately the same. So, I think we're answering the questions of how the drug can be labeled. But you have an additional, I think, nuanced question is, who is going to be the target patient? We believe the target patient is someone who is starting or restarting semaglutide or any other GLP-1 aggist or one that is titrating. And the use of the drug will be short and used as a preventive a few days before the initiation, restart, or higher titration, and then for a few days right after. So, not a chronic use, but rather an incidental use for the prevention of vomiting induced by GLP-1. And, you know, if you think about how is that prescriber decision to be made, a patient that may have experienced semaglutide GI tolerabilities at the lower level and is about to escalate, because it's necessary to escalate, that would be a very good candidate. Another candidate would be someone who escalated, experienced the eye tolerability issues, discontinued. Now they may get a chance to come back to the drug. So they're, you know, two populations that we think are going to be the most likely candidates. Now I forgot the other question.
No, no, that's very helpful. And that was it on those. And if I may, a follow-up regarding FNAP and Basanti. Could you remind us if you expect to break out Basanti and FNAP revenue once it launches? And now that we have some clarity on the launch, do you have a sense of how much of the FANAT to Basanti transition could occur by, say, mid-27? Thanks.
Yeah, I'll pass this on to Kevin, but I know that we have not guided yet on this. But I would say in modeling, given the economics and gross-to-net economics of Byzantium, which are far more favorable than FNAP, even a smaller portion of the 100% will be highly significant in that switch. Now, of course, we're going to be very, very focused on patient preference, physician preference, and, you know, payer dynamics as we will communicate. But Kevin?
Yeah, so maybe just a couple additional pieces of information there, Madison. First, on the question around breaking it out between Phenapt and Basanti, my expectation is that we will break it out between the two products in our disclosures. Obviously, we haven't had to do that yet, but that's my expectation as we move forward. And then on your second question around the expectations around potentially the split in the business, as Mahalas mentioned, we haven't guided that. Obviously, there's a number of sensitivities that we look at in terms of looking at that timeline. But to Mahalas' point, the gross to net is significantly favorable on Basanti relative to FNAF. The FNAP gross net that we've spoken about is in the neighborhood of about 50%, whereas our expectation on Basanti is that it will be more in the mid-30s. But the other thing I would tell you is the class and FNAPT as part of that class presents itself as a good candidate for this type of strategy because there's a number of new patients starting on a monthly basis, right? So, you know, in terms of the opportunity there to bring patients to Basanti treatment, given the number of MDRXs that we talk about with Phenaptin in the class, it presents a good opportunity to, you know, bring patients on to Basanti treatment as we head into next year and throughout next year.
Yeah, and just to add, as we're, you know, anxiously getting ready to launch Pisanti, at the same time, we will be patient with the switch because of the very clear dynamics of prescription lengths. Quite a few prescriptions in this domain are for 90 days, and therefore, you will not expect a switch, but in a gradual manner, you know, for these longer scripts. So I would say before we can start seeing the first quantifiable results of that switch, it may be three to four months after the launch.
Understood. Very helpful, guys. Thanks a lot.
Operator
Your next question comes from Olivia Saunders with Cantor. Your line is open.
Hi, good afternoon. Thank you for the question. Yeah, quick follow-up on Bisanti. I mean, just given the timing of Bisanti's upcoming launch relative to Phenaps LOE, how are you guys thinking about the pace of conversion, and any thoughts on the proportion of patients that you think you'll be able to transition in 2027, and whether there are maybe some ways to accelerate I don't know if there are maybe physician incentives to switch over or anything else. And then I've got a quick follow-up on Tredipotent.
Yes, certainly. So, the way we see the, as you say, transition, this is more of a transition of the company's emphasis as we recognize the There are benefits of the new drug, especially for potential indications, the developing of long-acting injectable formulations. But it is important to underscore something that Kevin said. The majority of patients who go and start on a new antipsychotic brand are patients who are stopping another drug and moving on to another one. They're not new patients in the market. So with that, FNAPT is not immune to that turnover. Maybe it is a little more sticky than others, but it's not immune to that turnover. And therefore, our emphasis is dual. To both capture new patient starts that are switching from other antipsychotics, but also, of course, offer Bisanti as a good solution for people who are seeing good results on FNAPT. So, you're going to see that the NBRXs or the New Starts will be a mixture of New Starts and FNAPT transition. We would like to have all of them and more, right? But as I was answering Madison's question, it's going to take three to four months to start seeing this pickup. Kevin?
I think that's right. And, Olivia, the only thing I would also just kind of spell out with the timeline is, you know, given we're in the fourth quarter of 2026 and the LOE on FNAPT is, you know, towards the end of 2027, we have a, you know, nice runway here where we're going to have both products being emphasized, as Malice mentioned, for the transition.
And then on Nereus or Trudipudin, how are you guys thinking about the price point as you look to next year's label expansion into GLP-1 patients? I mean, is this predominantly going to be a similar cash pay model, or are you expecting more of a reimbursement footprint here? And is there anything that you can do from a pricing standpoint just to try to help drive initial adoption?
Yeah. So, first of all, it is, you know, a little early. We need to get our data ready, get the application, earlier ramass for priority review. But absent that, it's going to be a 12-month review or so after application. So we're talking about most probably beyond lay 27. But a bit on pricing, to remind everybody that in the motion sickness market, we have priced the drug at a whack of $255, which is the retail price. And a 67% discount for cost-paying customers under certain restrictions, a government, et cetera, on our website, news.us. In terms of the philosophy of pricing for a GLP-1 indication, the most important thing for us is access. We develop drugs so people who need them can have them. So that is going to be the overarching philosophy as we think pricing or pricing flexibility. But we believe that Nereus is priced now well, and we begin to recognize that both from the Caspé consumer, But also the early elements of payer cabinets. It is early to see that full map, but we do see payer cabinets on the retail center.
Thank you very much, Chris.
Operator
Your next question comes from the line of Andrew Tassai with Jeffries. Your line is open.
Hi. Thank you for the updates. Really quickly, two questions. First one on Bisanti. For MDD, if it succeeds in first half 2027, do you intend to file on a single Phase III, or do you plan to run another Phase III? And then secondly, on GPP, can you remind us the patient TAM and the pricing power you could have? And for that application, have you guys entered into a final labeling discussion? Thank you.
Yeah, on the MDD, we certainly hope that the study will be positive with a good and persuasive magnitude of response. And based on that, and the history of the related drug FNAPT, the active metabolitis, Bisanti, and their bioequivalence, the approval of FNAPT and Bisanti for schizophrenia and bipolar disorder, And the large body of evidence of approximately 18 years that we will file successfully with one MDD study. And just to remind that this was exactly our conviction on the bipolar data, and the FDA agreed with that. Your question was on Quimilza and GPP. That is, as you know, an emerging market. They're telling me I have to fix something here, but okay, we're good. And as such, awareness around the recognition and diagnosis of the disorder is increasing, given the availability of another drug for the last couple of years. So, it is hard, really, to estimate. Different epidemiological surveys may suggest there are several thousand patients in the U.S. Very few of them are currently under treatment. We think Quimosa will offer a good solution based on the strong and robust data on reduction of acute flares, but also the prevention of additional flares and therefore maintenance indication. And I remind you that we feel that the backbone of an IgG4 antibody is a differentiating feature that predictably leads to a smaller percent of anti-drug antibodies, and therefore, some of it would be blocking antibodies, Where with an IgG4 backbone, you expect less, and we see less, and therefore, no surprises on the continuation of effect of a drug. The launch plan is being formulated, and we're engaging with a lot of the Q-opinion leaders across the U.S. and the world, and the academic centers where most of these patients are resolved diagnostically.
Operator
Thank you, Andrew. And with no further questions in queue, I'd like to turn the conference back over to Vanda's management for closing remarks.
Thank you all for joining us. Good night.
Operator
This concludes today's earnings call. You may now disconnect.
