VNDA

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET President, Chief Executive Officer, and Chairman of the Board - Mihael Polymeropoulos Chief Financial Officer - Kevin Patrick Moran General Counsel - Daniel McGuire Operator: Good afternoon, and welcome to the Second Quarter 26 Vanda Pharmaceuticals Incorporated Earnings Conference Call. I am Frans, and I will be the operator assisting you today. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press *1 on your telephone keypad. If you would like to withdraw your question, please press *1 again. Thank you. I would now like to turn the call over to Vanda's chief financial officer. Kevin Patrick Moran. Please go ahead. Kevin Patrick Moran: Thank you, France. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 26 performance. Our second quarter 26 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 call on our website. Joining me on today's call is Dr. Mihael Polymeropoulos, our president, chief executive officer, and chairman of the board, and Daniel McGuire, our general counsel. Following my introductory remarks, Mihael 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, which 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 ks, 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. 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. Mihael Polymeropoulos. Mihael H. Polymeropoulos: Good afternoon, everyone. Thanks for joining us today. Vanda Pharmaceuticals second quarter 26 Earnings Conference Call. We are pleased with the continued strong growth of Fanapt and the enthusiastic response to NEREUS as it becomes available to patients. With BYSANTI approved and on track for launch in the second half of 2 thousand 26, a December 2026, PDUFA date for Imsidolimab and multiple late stage clinical trial results expected before year end, we believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation. As our phase 3 programs launch preparations in commercial supply manufacturing, near completion. We expect operating expenses to begin moderating later this year and more significantly in 2027. We believe that our current resources together with anticipated project revenues provide a solid foundation to advance our objectives through at least the end of 2 thousand 27. During 2025 and 2026, we have advanced multiple phase 3 programs continued execution of the commercialization of Fanapt and PONVORY and prepared for the commercial launches including manufacturing, commercial supplies of NEREUS, BYSANTI, and Imsidolimab. As these activities conclude, we expect operating expenses to begin decreasing by the end of 26 and more substantially through 2027. Based on our current cash position, and anticipated revenues, we expect to have sufficient resources to fund operations through at least the end of 2 thousand 27. Fanapt showed continued strong momentum in the second quarter of 2 thousand 26 with total prescriptions TRx up 31% and new to brand prescriptions NBRx up 32% versus the second quarter of 2 thousand 25. Since commercial expansion following the approval of bipolar I disorder, Fanapti has seen significant growth with TRx up 62% and BRx up 300%. Versus the second quarter of 2 thousand 24. BYSANTI received US Food and Drug Administration approval for the treatment of bipolar I disorder and schizophrenia in the first quarter of 26 and is expected to launch in the second half of 2 thousand 26. BYSANTI is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. In May 2026, early commercial launch of NEREUS was initiated as a direct to consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Vantage's ongoing late stage clinical studies are progressing rapidly and are expected to generate top line results in 2026 or early 27, including the fetus phase 3 study of NEREUS for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies with results expected in 2026. The phase 3 study of VQW 65 for the treatment of adults with social anxiety disorder with results expected in 2026. The phase 3 study of HETLIOZ for the treatment of delayed sleep phase disorder, DSPD, with results expected in 2026. Finally, the phase 3 study of BYSANTI as a once daily adjunctive treatment for major depressive disorder with results expected in the first half of 2 thousand 27. The biologic license application, BLA, for Imsidolimab in generalized postural psoriasis. Is under review by the FDA with a prescription drug user fee act target action date of December 12, 2026. The results of the pivotal clinical study was published earlier in April 28, 2026 in the New England Journal of Medicine. Evidence. In May 2026, we announced that Japan's Ministry of Health Labor and Welfare granted orphan drug designation to Imsidolimab for the treatment of GPP. In July 2026, we announced that the committee for orphan medicinal products at the European Medicines Agency had adapted a positive opinion recommending orphan drug designation for Imsidolimab for the treatment of GPP. In July 2026, we announced that the FDA had granted rare pediatric disease designation for VCA-894A our investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease type 2S, or CMT2S, a serious and progressive inherited neurological disorder. We continue to progress the FDA formal hearing regarding HETLIOZ for use in the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the DC circuit set aside the FDA's prior refusal to approve the application is advancing according to schedule and is expected to culminate in a 5-day hearing before the administrative law judge in December 2026. With that, I will turn now to Kevin to discuss our financial results. Kevin? Kevin Patrick Moran: Thank you, Mihael. I will begin by summarizing our financial results for the first 6 months of 26 before turning to discuss the second quarter of 2020 6. Total revenues for the first 6 months of 26 were 102.2 million, essentially flat as compared to $103 million for the same period in 2025. The first 6 months of 26 included increased Fanapt revenue, as a result of the continued commercialization efforts for Fanapt in bipolar I disorder, increased PONVORY revenue, and revenue contribution from the newly launched NEREUS. Offset by decreased Hetlioz revenue as a result of generic competition and timing of shipments to customers at the end of the second quarter of 2020 6. Total revenues for the first 6 months do not include approximately $7 million of HETLIOZ revenue, for orders shipped on June 29, 2026 that arrived on July 1, 2020 Let me break this down now by product. Fanapt net product sales were 65.5 million for the first 6 months of 26, 24% increase compared to 52.8 million in the same period in 2025. This increase to net product sales relative to the first 6 months of 2025 attributable to an increase in volume, partially offset by a decrease in price net of deductions. Turning to Hetlioz. Hetlioz net product sales were 21.5 million for the first 6 months of 2020, a 42% decrease compared to 37.1 in the same period in 2025. The decrease was attributable to a decrease in volume as a result of continued generic competition in the US and the timing of shipments to customers at the end of the second quarter of 2020 6. Hetlioz net product sales for the first 6 months of 2020 do not include orders totaling approximately $7 million in revenue that were shipped on June 29 and arrived on July 1. Orders will be recognized as revenue in the third quarter of 26. During the second quarter of 2020 6, there was destocking of inventory by certain of our specialty pharmacy customers, primarily as a result of the previously mentioned shipment issue. Of note, for the second quarter of 2020 6, HETLIOZ continued to be the leading product from a market share perspective despite generic competition now for over 3 years. Turning to Ponvory. Ponvory net product sales were 14.1 million for the first 6 months of 26, an 11% increase compared to 12.7 million for the same period in 2025. Of note, an amount of variable consideration related to PONVORY net product sales are subject to dispute, of which approximately 3 million was recognized for the 3 months ended December 31, 2024. And finally, turning to Nirius. NEREUS became commercially available in the US in May 2026. NEREUS net product sales were $1 million for the first 6 months of 2026. NEREUS is sold using both the traditional wholesaler channel and also by prescription directly through the nereus.us website. Revenue recognized during the first 6 months of 2026 primarily related to units sold through the wholesaler channel. During the second quarter of 2020 6, there was an initial stocking of NEREUS by wholesalers of $15.2 million. We constrain NEREUS net product sales to an amount probable of significant revenue reversal. The constrained revenue of $12.6 million relates to the uncertainties of patient demand and product returns related to the elevated levels of inventory on hand at wholesalers. As a reminder, NEREUS launched commercially in the US in the second quarter of 2020 6 with the direct to consumer offering via the web portal, nereus.us. Personal promotion using our existing salesforce is expected to commence later in 2026. For the first 6 months of 26, Vanda recorded a net loss of $111.1 million compared to a net loss of $56.7 million for the same period in 2025. The net loss for the first 6 months of 2026 included income tax expense of $300 thousand as compared to an income tax benefit of $15.6 million for the same period in 2025. As a reminder, the company recorded a onetime noncash income tax charge in the fourth quarter of 25 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 6 months of 2026 were $216.3 million compared to $182.82 million for the same period in 2025. The $34.1 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 Fanapt in bipolar I disorder and PONVORY in multiple sclerosis, the NEREUS commercial launch the upcoming BYSANTI commercial launch, and higher R&D expenses primarily related to our VQW, Fanapt, and BYSANTI programs partially offset by lower expenses on our Imsidolumab program. The first 6 months of 2025 included an upfront payment to AnaptysBio for the exclusive global license agreement for the development and commercialization of imsidolumab. On the commercial side, starting in 2024, we commenced the host of activities as a result of the commercial launches of Fanapt in bipolar I disorder and PONVORY in multiple sclerosis. And more recently, the launch of NEREUS and upcoming launch of BYSANTI. 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. Vanda's cash, cash equivalents, and marketable securities referred to as cash as of June 30, 2026 was $170 million. Representing a decrease of $93.8 million compared to December 31, 2025, and a decrease of $32.3 million compared to March 31, 2026. The change in cash during the second quarter of 2020 as compared to the first quarter of 26 was driven by the net loss in second quarter of 2020 6, excluding the impact of noncash 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, the timing of cash paid to third parties for services related to operating expenses and inventory production. The decrease compared to the balance as of December 31, 2025 was also driven by the onetime milestone payment of $10 million made to Eli Lilly in the first quarter of 26 for the approval of Nirius in The US. As a reminder, payments made in advance of production are capitalized as a prepaid expense, Commercial products, are capitalized as inventory on our balance sheet after production, while precommercial products are generally expensed as incurred as research and development costs. The timing of production of precommercial products, including the imsadolumab program, may result in future variability of our r and d expense and cash payments. Turning now to our quarterly results. Total revenues were $50.5 million for the second quarter of 2020 6, a 4% decrease compared to $52.6 million for the second quarter of 2020 5, and a 2% decrease compared to $51.7 million in the first quarter of 26. The decreases as compared to the second quarter of 2020 5 and the first quarter of 26 primarily due to a decrease in HETLIOZ revenue as a result of generic competition and the timing of shipments to customers at the end of the second quarter of 2020 6 partially offset by growth in FNAF revenue as a result of the bipolar commercial launch. Revenues for the second quarter of 2020 6 do not include approximately $7 million of HETLIOZ revenue, for orders shipped on June 29 arrived on July 1. Let me now break this down by product. FNAP net product sales were $36 million for the second quarter of 2020 6. A 23% increase compared to $29.3 million in the second quarter of 2020 5. And a 22% increase compared to $29.6 million in the first quarter of 26. Fanapt total prescriptions or TRx, as reported by IQVIA Xponent, the second quarter of 2020 6 increased by 31% compared to the second quarter of 2020 5 and 11% compared to the first quarter of 26. The increases to net product sales relative to the second quarter of 2020 and first quarter of 26 were primarily attributable to increases in volume. Fanaptan new patient starts in the second quarter of 2020 6 as reflected by new to brand prescriptions or NBRx increased by 32% compared to the second quarter of 2020 5 and by 10% compared to the first quarter of 26. Historically, FNAF's inventory at wholesalers has ranged between 3 and 4 weeks on hand as calculated based off trailing demand. As of the end of the second quarter of 2020 6, FNAF's inventory at wholesalers was slightly above 4 weeks on hand, was generally consistent with the level of inventory weeks on hand as of the first quarter of 26 and the fourth quarter of 25, but slightly above the historic range. Turning to Hetlioz. HETLIOZ net product sales were $5.6 million for the second quarter of 2020 6, a 66% decrease compared to $16.2 million in the second quarter of 2020 5, and a 65% decrease compared to $15.9 million in the first quarter of 26. The decrease in net product sales relative to the second quarter of 2020 5 was the first quarter and the first quarter of 26 was primarily attributable to a decrease in volume due to generic competition and timing of shipments to customers at the end of the second quarter. Hetlioz net product sales in the second quarter of 2020 6 do not include orders totaling approximately $7 million in revenue that were shipped on June 29 and arrived on July 1. Orders will be recognized as revenue in the third quarter of 26. As mentioned in the discussion of results for the first 6 months of 26, Hetlioz net product sales continue to be impacted by changes in inventory stocking at specialty pharmacy from period to period. During the second quarter of 2020 6, there was destocking of inventory by certain of our specialty pharmacy customers primarily as the result of timing of shipments. Going forward, Hetlioz net product sales may reflect lower unit sales as a result of the reduction of the elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Turning to PONVORY. PONVORY net product sales were $7.9 million for the second quarter of 2020 6. An increase of 12% compared to $7.1 million in the second quarter of 2020 5 and an increase of 27% compared to $6.2 million in the first quarter of 26. Specialty distributor and specialty pharmacy inventory on hand levels during these periods were in line with normal ranges. Additionally, as we have previously discussed, an amount of variable consideration related to PONVRI net product sales is subject to dispute, of which approximately $3 million was recognized for the 3 months ended December 30, 2024. And finally, turning to Nirius. NEREUS became commercially available in The US in May 2026 NEREUS net product sales were $1 million for the second quarter of 2020 6. Nerius is sold using both traditional wholesaler channel and also by prescription directly through the nerius.us website. Revenue recognized during the second quarter of 2020 6 primarily related to units sold through the wholesaler channel. The second quarter of 2020 6, there was an initial stocking of Nirius by wholesalers of $15.2 million, constrain Nirius net product sales to an amount not probable of significant revenue reversal. The constrained revenue of $12.6 million relates to the uncertainties of patient demand and product returns related to the elevated inventory levels on hand at wholesalers. As a reminder, Nirius launched commercially in the US in the second quarter of 2020 6 with the direct to consumer offering via the web portal, nearius.us. Personal promotion using our existing salesforce is expected to commence later in 2026. For the second quarter of 2020 6, Vanda's recorded a net loss of $62.5 million compared to a net loss of $27.2 million for the second quarter of 2020 5. The net loss for the second quarter of 2020 6 included income tax expense of $100 thousand as compared to an income tax benefit of $7.7 million for the second quarter of 2020 5. Operating expenses in the second quarter of 2020 6 were $114.3 million compared to $91.1 million in the second quarter of 2020 The $23.2 million increase was primarily driven by higher R and D expense related to our VQW and Nirius programs, and higher SG&A expenses related to spending on Vanda's commercial products as a result of the continued commercialization efforts for Fanapt in bipolar I disorder and Ponviria multiple sclerosis. The nearest commercial launch and upcoming BYSANTI commercial launch. On the commercial side, starting in 2024, we commenced a host of activities as a result of the commercial launches of Fanapt in Bipolar I disorder PONVORY in multiple sclerosis and more recently the launch of NEREUS and upcoming launch of BYSANTI. 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 in bipolar I disorder and PONVORY in multiple sclerosis, I mentioned, these launches were initiated in 2024, and we continue to enhance our commercial infrastructure the second quarter of 2020 6. With the impact of these commercial efforts contributing to revenue growth for these products in 2026 and expected to continue to contribute to revenue growth for these products in coming periods. We have seen significant growth in our commercial activities, including the following. Several lead indicators suggesting a strong and continued market response to our commercial activities related to FNAP for bipolar I disorder. Total prescriptions or TRx is increasing by approximately 31% in second quarter of 2020 6 as compared to the second quarter of 2020 5. In May 2026, a weekly TRx number for FNAP reaching an 11-year high of over 2.7 thousand prescriptions. New patient starts as reflected by NBRx increased by 32 percent in the second quarter 26 as compared to the second quarter of 2020 5. Since the commercial expansion following the approval of bipolar I disorder Fanapt has seen significant growth with TRx up 62% and NBRx up 300%. As compared to the second quarter of 2020 4. Of particular note, Fanapta is 1 of the fastest growing atypical antipsychotics in the market throughout 2025 and into the second quarter of 2020 based on several prescription metrics. Our Fanapt sales force expanded to approximately 300 representatives in the second half of 25, 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 second quarter of 2020 6 was more than 30% higher than the number of face to face calls in the second quarter of 2020 5. FNAF performance remains the focus of our commercial initiatives and encourages us to invest in this differentiated medicine and the franchise extending launch of Vasanti in the second half of 26. Before turning to our financial guidance, I would like to remind folks that with Fanapt, Hetlioz, Pomvori, and now NEREUS already commercially available and with Basanti recently approved for bipolar I disorder and schizophrenia, and a biologics license application for imsadolumab is now under review by the FDA. Vanda could have 6 approved products by the end of 26. Turning now to our financial guidance. Vanda is reiterating its full year 2026 total revenue guidance and expects to achieve the following financial objectives in 2026: Total revenues from Fanapt, BYSANTI, Hetlioz, PONVORY, and NEREUS of between $240 and $290 million. The midpoint of this revenue range of $265 million would imply revenue in 2026 of approximately 23% as compared to full year 2025 revenue. Fanapt and BYSANTI net product sales of between $150 and $170 million, The midpoint of this revenue range would imply combined Fanapt and BYSANTI revenue growth in 2026 of approximately 36% as compared to full year 2025 Fanapt revenue. Note that based on the expected launch timing of BYSANTI, we have included the BYSANTI revenue contribution in this guidance range. Other net product sales of $80 and $90 million, And finally, NEREUS net product sales of $10 and $30 million. Note that NEREUS launched commercially in the US in the second quarter of 2020 6, with the direct to consumer offering via the web portal nerius.us. Personal promotion using our existing salesforce is expected to commence later in 2026. 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 advanced multiple phase 3 programs, continued execution on the commercialization of Fanapt and PONVORY, and prepared for the commercial launches, including manufacturing commercial supplies of Nirius, BYSANTI, and Imsidolimab. These activities resulted in significantly increased operating expenses in 2025 and 2026. As these activities conclude, Vanda expects operating expenses to begin decreasing by the end of 26 and more substantially throughout 2027. Based on its current cash position of $170 million as of June 30, 2026, and anticipated future revenues, Vanda expects to have sufficient resources to fund operations through at least the end of 27. With that, I will now turn the call back to Mihael. Mihael H. Polymeropoulos: Thank you very much, Kevin. At this point, we will be happy to answer your questions. Thank you. Operator: And we will now begin the question and answer session. If you would like to ask a question during this time, please press 1 on your keypad to join the queue. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. And your first question comes from Raghuram Ram Selvaraju from H. C. Wainwright. Please go ahead. Yanzi: Hi. Thank you for taking my question. This is This is Lin Tsai, sitting in for Ram. I have 2 questions. The first is with respect to the NEREUS launch experience. So I am curious, you know, with about 3 months of, experience here, where are you seeing the biggest drop off in the patient funnel And what metrics should investors watch to judge whether the 26 failed to finish near the low or the high end of the $10 million to $30 million range. Kevin Patrick Moran: Yeah. Thanks for the question, Lin. So as we look at the Nirius launch, we are obviously very early in the launch phase here. We initiated our launch activities in May. First, with the nereus.us platform. And DTC campaigns following that. As we head into the back half of the year, going to be initiating personal promotion with our Salesforce, which we expect to support, you know, the activities that we are seeing out there in the field. You know, as far as metrics go for what folks should be looking for there, I think that, you know, as we continue to report going forward, the sales engagement and the visits that we see with doctors and the receptivity to the product in the market is going to be important. To seeing what trends we see as far as revenue goes. And then similarly to what we discussed in the prior quarter call, some of the important levers here as far as the revenue trajectory and modeling it out, will be the, you know, patient acquisition metrics as well as refill metrics and the pills per fill metrics, which obviously, early in the launch year, we are starting to get some data, but it is fairly minimal. So we will continue to be tracking that closely to determine kind of where in the revenue range we expect to fall in future periods. Yanzi: Thank you so much. And 1 more about HETLIOZ. So following the July 20, pre-hearing conference and the August 3, evidentiary disclosure deadline, what became clear about the hearing for that overall? And which issue is most likely to drive the outcome? Do you think it would be something like interpretation of sites from 3.1 thousand and 3.11 thousand endpoint validity? Or something else? Mihael H. Polymeropoulos: Yes. Thanks for the question. I have our General Counsel here, McGuire, to explain a little bit about the process. The pre hearing was more of a process call than actually looking at the facts, Daniel? Daniel McGuire: Yes. that is right. And so, obviously, it is never a good idea to speculate about the outcome of litigation or litigation strategy. But you know, we are confident in our ability to present our case to the administrative law judge. The process will continue throughout the year. And, we are you know, hoping obviously for a favorable recommendation from the judge, early in 2027. Operator: Your next question comes from Madison El-Saadi from B. Riley Securities. Please go ahead. Madison: Hi. Thanks for taking our question. A couple from us. Maybe sticking with the NEREUS campaign. What exactly does the personal promotion start? How many reps are we talking And does that spend sit inside the OpEx moderation you guided to relatedly now that you are guiding to the OpEx to come down later in 2026 and 2027, is that more related to R&D or SG&A? And then what drove the Q2 R&D expense? Thanks. Kevin Patrick Moran: Yeah. Thanks, Madison. So first on the NEREUS launch side, as we have spoken about before, we have a Salesforce to support our FNAP franchise, you know, and soon to be BYSANTI franchise in the neighborhood of approximately 300 representatives. As well as Salesforce in the neighborhood of 50 supporting our Pomvori efforts. And so we will be using some element of those 2 Salesforce's to be detailing, you know, NEREUS in the future. it is yet to be determined exactly kind of what the structure is, but we have sufficient resources between those 2 teams, to reach the prescribers that we are looking to reach. On your second question around kind of what we are seeing from an expense trajectory perspective, so as we have gone through 2025 and 2026, we now have, you know, 4, phase 3 programs set to read out either before the end of the year or early in 2027. We have 3 potential launches with NEREUS, BYSANTI, and hopefully in the future, imsidolumab. And so the, you know, the obviously, the cost of running those phase 3 programs is not insignificant. And the commercial production in order to make sure that we have sufficient supply for the launch of those, products is also a significant investment. So as we, you know, have now reached or are reaching the end of those activities with the readouts of the clinical trials, you know, kind of right in front of us, and the launch materials, you know, either made or being made shortly, those will be driving the most, you know, significant reductions in operating expenses as we head towards the end of 26 and into 2027. And, Madison, to the second part to your question there, the significant increase in r and d operating expenses during the period, again, was the ramp up of those programs that, you know, have kind of reached their, or are reaching their conclusion shortly. And, also, for some of the products that are not yet approved, namely imsidolumab, any of the production activities that are associated with making that inventory, are expensed as incurred to r and d and that is just an accounting treatment of you can capitalize inventory once the product is approved. Whereas, generally, prior to approval, you expense that as r and d, and it would hit our r and d line item. So those are the significant drivers, in the current period. Got it. Thanks, Kevin. Appreciate it. Operator: No further questions at this time. I would now like to turn the call back over to Vanda's management for the closing remarks. Please go ahead. Mihael H. Polymeropoulos: Thank you very much all for joining I am sorry. Oh. Do we have another question? Sorry. Operator: We do actually have a follow-up coming from Lin Tsai from Jefferies. Would you take the question? Mihael H. Polymeropoulos: Yeah. Please, let Lin in. Operator: Okay. Go ahead. Andrew: So thanks so much for can you hear me okay? Yep. We can hear you. Oh, okay. Yes. So on the VQW-765 program, I was hoping maybe you guys could talk about your prior phase 2 data and maybe what exactly gives you confidence that you could succeed in phase 3 and maybe even why efficacy can look even better. In phase 3? Thanks. Mihael H. Polymeropoulos: Yeah, thanks for the question. The phase 3 study that we are running now is similar in design with a phase 2 study. With a similar setup and similar primary endpoint. And we have reported prior results there. With 2 observations. 1, a significant effect in reducing anxiety measures in that setting. But also understanding of a dose response curve. So this phase 3 study we believe has been appropriately powered with the right number of patients that was informed by the phase 2 study. So again, minimal changes in the design no change in the dose, but increase in the size of the study to be powered according to the learnings from the phase 2 study. Andrew: Great. Thanks so much. And then maybe 1 more if I can. I am wondering you know, if you could possibly talk about your, you know, your filing strategy or potentially timing for the GLP-1 induced vomiting for NEREUS. And then just kind of second to that, have you aligned with the FDA on the Phase 3 trial design? And then maybe just your latest and greatest on what you hope to see relative to the phase 2 findings. Mihael H. Polymeropoulos: Yeah. So just to remind everyone on the call, last November, we reported a positive study on the effects of NEREUS in preventing vomiting. In people who take GLP-1 analogs in the design of administrative Wegovy at 1 milligram. Which is an advanced dose without any titration. And the results pretty much show that while 60% of the people on placebo, approximately, vomited in that design, only about 30 percent of the patients with NEREUS did so showing a significant protection. So the current design is a similar design where we aim to confirm the prior findings. We believe that this body of evidence alongside with all the NEREUS experience this approved product will suffice for the filing of a supplemental NDA. We continue to communicate with the FDA on the statistical analysis plan on this study. And we will see how the results go and we will continue those conversations. Great. Thanks so much. Operator: As of now, there are no further questions at this time. Again, I would now like to turn the call back over to Vanda's management. for the closing remarks. Please go ahead. Mihael H. Polymeropoulos: I thank you all for your questions, and thank you for joining this call. Thank you. Operator: Ladies and gentlemen, thank you all for joining, and that concludes today's conference call. All participants may now disconnect. Thank you. Before you buy stock in Vanda Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Vanda Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Vanda (VNDA) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Fanapt growth was driven by the successful commercial expansion into bipolar I disorder, resulting in a 31% increase in total prescriptions compared to Q2 2025 and a 300% increase in new-to-brand prescriptions compared to Q2 2024. Management attributed the significant increase in operating expenses to the simultaneous advancement of four Phase 3 programs and manufacturing preparations for three new product launches. Hetlioz revenue declined by 66% due to sustained generic competition and a specific $7 million shipment delay that shifted revenue recognition into the third quarter. The company expanded its Fanapt sales force to approximately 300 representatives, leading to a 30% increase in face-to-face prescriber calls compared to the prior year. NEREUS launched via a direct-to-consumer web portal in May 2026, with management utilizing a conservative revenue recognition approach due to initial wholesaler stocking uncertainties. Strategic investments in commercial infrastructure and brand visibility were maintained to support the transition from a legacy product focus to a multi-product portfolio. Operating expenses are expected to begin moderating in late 2026 and decrease more substantially in 2027 as Phase 3 clinical trials and launch manufacturing activities conclude. Management anticipates having sufficient resources to fund operations through at least the end of 2027 based on current cash and projected revenue growth. The company expects to have up to six approved products by the end of 2026, pending the December PDUFA date for Imsidolimab and the launch of BYSANTI. Revenue guidance for 2026 assumes a 23% increase at the midpoint, heavily dependent on the successful second-half launch of BYSANTI and the commencement of personal promotion for NEREUS. Top-line results for multiple Phase 3 studies, including NEREUS for GLP-1 induced vomiting and HETLIOZ for delayed sleep phase disorder, are expected before the end of 2026. A $7 million revenue shortfall in Q2 was explicitly linked to the timing of shipments that arrived on July 1 instead of June 30, causing a temporary destocking effect at specialty pharmacies. The company recorded a $12.6 million revenue constraint for NEREUS to account for potential returns and uncertain patient demand following an initial $15.2 million wholesaler stocking. A $10 million milestone payment was made to Eli Lilly in Q1 2026 following the U.S. approval of NEREUS, contributing to the year-to-date cash decrease. Management flagged ongoing disputes regarding variable consideration for PONVORY net product sales, noting that $3 million was previously recognized under dispute. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that personal promotion using the existing 300-person sales force will begin later in 2026 to supplement current direct-to-consumer efforts. Key performance indicators for the launch include patient acquisition, refill rates, and pills-per-fill metrics, though data remains minimal in the early launch phase. The upcoming December 2026 hearing regarding jet lag disorder is a rare administrative process granted after a court set aside a prior FDA refusal. Management expressed confidence in their evidentiary case but noted a final recommendation from the administrative law judge is not expected until early 2027. Confidence in the Phase 3 trial stems from Phase 2 data that demonstrated a significant reduction in anxiety and established a clear dose-response curve. The Phase 3 study maintains the same design and dosage as Phase 2 but is significantly higher powered to confirm prior findings. Vanda intends to file a supplemental NDA based on Phase 2 data showing NEREUS reduced vomiting incidence from 60% to 30% in patients taking GLP-1 analogs. The company is currently aligning with the FDA on the statistical analysis plan for the confirmatory Phase 3 study.

Interested in Vanda Pharmaceuticals Inc.? Here are five stocks we like better. Revenue fell 4% year over year to $50.5 million in Q2 2026, as Fanapt growth and higher PONVORY sales were offset by a 66% drop in HETLIOZ revenue due to generic competition and shipment timing. Vanda maintained its full-year revenue forecast of $240 million to $290 million. Fanapt sales rose 23% to $36 million, while newly launched NEREUS generated $1 million in recognized revenue amid cautious inventory management. BYSANTI is expected to launch in the second half of 2026, adding another potential growth driver. Net loss widened to $62.5 million from $27.2 million as research, launch and commercial expenses increased; cash and marketable securities fell to $170 million. Management expects operating expenses to start declining late this year and more substantially in 2027, with cash expected to fund operations through at least the end of 2027. Vanda Pharmaceuticals (NASDAQ:VNDA) reported second-quarter 2026 revenue of $50.5 million, down 4% from a year earlier, as growth in Fanapt and PONVORY was offset by lower HETLIOZ sales amid generic competition and shipment timing. The company reiterated its full-year revenue outlook and said it expects operating expenses to begin declining late this year, with more substantial reductions anticipated in 2027. Chief Executive Officer Mihael Polymeropoulos said the company was encouraged by continued growth for Fanapt and the initial availability of NEREUS. He also pointed to the planned second-half launch of BYSANTI, an FDA decision expected in December for Quimilza, and several anticipated late-stage clinical readouts as drivers of potential commercial expansion. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Fanapt net product sales rose 23% year over year to $36 million in the second quarter and increased 22% sequentially from $29.6 million in the first quarter. The sales growth was primarily driven by volume, according to Chief Financial Officer Kevin Moran. Total Fanapt prescriptions increased 31% from the second quarter of 2025 and 11% from the first quarter, while new-to-brand prescriptions rose 32% year over year and 10% sequentially. Moran said a weekly Fanapt prescription count exceeded 2,700 in May, representing an 11-year high. → 3 Drone Stocks That Should Soar After the Summer Slump The company said Fanapt’s commercial expansion following its bipolar I disorder approval has supported substantial prescription growth since the second quarter of 2024. Total prescriptions were up 62% over that period, while new-to-brand prescriptions increased 300%. HETLIOZ net product sales, however, fell 66% year over year to $5.6 million in the quarter and declined 65% from the first quarter. Vanda attributed the decrease to lower volumes stemming from U.S. generic competition, as well as shipment timing and inventory destocking by specialty pharmacy customers. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The company said second-quarter HETLIOZ revenue did not include approximately $7 million from orders shipped June 29 that arrived July 1. That revenue is expected to be recognized in the third quarter. Despite generic competition, Moran said HETLIOZ remained the leading product by market share. PONVORY net product sales increased 12% from a year earlier and 27% sequentially to $7.9 million. NEREUS, which became commercially available in the U.S. in May, generated $1 million in second-quarter net product sales. Vanda initiated the NEREUS launch through a direct-to-consumer web portal, nereus.us, and plans to begin personal promotion later in 2026. The company said it will use some portion of its approximately 300-representative Fanapt and BYSANTI sales force and its roughly 50-person PONVORY sales force to support NEREUS promotion, though the final structure has not been determined. Wholesalers initially stocked $15.2 million of NEREUS during the quarter. Vanda recognized $1 million in revenue and constrained $12.6 million because of uncertainty surrounding patient demand, potential product returns, and elevated wholesaler inventory levels. In response to an analyst question, Moran said investors should monitor physician engagement, patient acquisition, refills and pills per fill as the company develops more launch data. He described NEREUS as still being in an early launch phase. BYSANTI received FDA approval during the first quarter for bipolar I disorder and schizophrenia and is expected to launch during the second half of 2026. Polymeropoulos said the product has data exclusivity through Feb. 20, 2031, along with patents extending as late as May 2044. Vanda expects multiple phase III results in 2026 or early 2027, including studies of NEREUS for prevention of vomiting in patients receiving GLP-1 receptor agonists, VQW-765 for social anxiety disorder, and HETLIOZ for delayed sleep phase disorder. A phase III study of BYSANTI as an adjunctive treatment for major depressive disorder is expected to report results in the first half of 2027. Polymeropoulos said the ongoing NEREUS GLP-1 study is designed to confirm findings from a prior study. In that earlier trial, which administered Wegovy at a 1-milligram dose without titration, approximately 60% of placebo-treated participants vomited, compared with roughly 30% of those receiving NEREUS, he said. The company believes the evidence could support a supplemental new drug application, pending trial results and continued FDA discussions. The FDA is reviewing the biologics license application for Quimilza, or imsidolimab, in generalized pustular psoriasis, with a target action date of Dec. 12, 2026. The company also said Japan granted orphan drug designation for Quimilza in May, while the European Medicines Agency’s orphan-drug committee issued a positive designation opinion in July. Vanda expects an administrative hearing concerning HETLIOZ for jet lag disorder to take place over five days in December 2026. General Counsel Daniel McGuire said the company was confident in presenting its case but declined to speculate on the outcome, adding that Vanda hopes for a favorable recommendation from the administrative law judge in early 2027. Vanda reported a second-quarter net loss of $62.5 million, compared with a loss of $27.2 million a year earlier. Operating expenses increased to $114.3 million from $91.1 million, driven by higher research and development spending on VQW-765 and NEREUS, as well as selling, general and administrative spending for Fanapt, PONVORY, the NEREUS launch and the upcoming BYSANTI launch. For the first six months of 2026, revenue was essentially flat at $102.2 million, while the net loss widened to $111.1 million from $56.7 million in the prior-year period. Cash, cash equivalents and marketable securities totaled $170 million as of June 30, down $93.8 million from year-end 2025. Management said the increased spending reflects late-stage trials, commercial-launch preparation and production of commercial supply. As those activities conclude, the company expects expenses to begin decreasing by the end of 2026 and to decline more substantially during 2027. Vanda said its current cash position and anticipated product revenue should fund operations through at least the end of 2027. The company reiterated 2026 total revenue guidance of $240 million to $290 million, including projected Fanapt and BYSANTI sales of $150 million to $170 million and NEREUS sales of $10 million to $30 million. Vanda did not provide cash guidance but said 2026 cash burn is likely to exceed its 2025 level. Vanda Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders and rare diseases. The company's research and development efforts center on sleep-wake regulation, mood disorders, and movement disorders. Vanda's mission is to address unmet medical needs by advancing novel molecules through clinical trials and regulatory review. Vanda's flagship commercial product is Hetlioz (tasimelteon), a melatonin receptor agonist approved by the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Vanda Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Fanapt® Q2 2026 net product sales increased 23% to $36.0 million; total prescriptions increased 31% Full-year 2026 total revenue guidance of $240-$290 million Cash totaled $170.0 million as of June 30, 2026; expected to fund operations through at least the end of 2027 BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia in Q1 2026; commercial launch expected in second half of 2026 Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026 NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026 Results for three Phase III clinical trials expected by end of 2026: WASHINGTON, Aug. 5, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2026. "We are pleased with the continued strong growth of Fanapt and the enthusiastic early response to NEREUS as it becomes available to patients. With BYSANTI approved and on track for launch in the second half of 2026, a December 2026 PDUFA date for Quimilza and multiple late-stage clinical trial results expected before year-end, we believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "As our Phase III programs, launch preparations, and commercial supply manufacturing near completion, we expect operating expenses to begin moderating later this year and more significantly in 2027. Our current resources, together with anticipated product revenues, provide a solid foundation to advance our objectives through at least the end of 2027." Financial Highlights During 2025 and 2026, we have advanced multiple Phase III programs, continued execution on the commercialization of Fanapt® (iloperidone) and PONVORY® (ponesimod) and prepared for the commercial launches, including manufacturing commercial supplies, of NEREUS™ (tradipitant), BYSANTI™ (milsaperidone), and Quimilza™ (imsidolimab). These activities resulted in significantly increased operating expenses in 2025 and 2026. As these activities conclude, Vanda expects operating expenses to begin decreasing by the end of 2026 and more substantially throughout 2027. Based on its current cash position and anticipated revenues, Vanda expects to have sufficient resources to fund operations through at least the end of 2027. Second Quarter of 2026 Total net product sales were $50.5 million in Q2 2026, a 4% decrease compared to $52.6 million in Q2 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $36.0 million in Q2 2026, up 23% year-over-year. HETLIOZ® (tasimelteon) net product sales were $5.6 million in Q2 2026, down 66% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $7.9 million in Q2 2026, up 12% year-over-year. NEREUSTM net product sales were $1.0 million in Q2 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $62.4 million in Q2 2026 compared with $34.9 million in Q2 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $32.3 million in Q2 2026. First Six Months of 2026 Total net product sales were $102.2 million in the first six months of 2026 as compared to $102.6 million in the first six months of 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $65.5 million in the first six months of 2026, up 24% year-over-year. HETLIOZ® net product sales were $21.5 million in the first six months of 2026, down 42% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $14.1 million in the first six months of 2026, up 11% year-over-year. NEREUSTM net product sales were $1.0 million in the first six months of 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $110.8 million in the first six months of 2026 compared with $72.3 million in the first six months of 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $93.8 million compared to December 31, 2025. Key Commercial Highlights Fanapt® saw continued strong momentum in Q2 2026, with total prescriptions (TRx)1 up 31% and new-to-brand prescriptions (NBRx)1 up 32% versus Q2 2025. Since commercial expansion following the approval of bipolar disorder, Fanapt® has seen significant growth, with TRx1 up 62% and NBRx1 up 300% versus Q2 2024. BYSANTI™ received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia in Q1 2026 and is expected to launch in the second half of 2026. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. In May 2026, the early commercial launch of NEREUS™ was initiated with a direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Key Regulatory & Clinical Development Highlights Upcoming Clinical Milestones Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: Other Updates The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) 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 England Journal of Medicine (NEJM) Evidence2. In May 2026, Vanda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation to Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) had adopted a positive opinion recommending orphan drug designation for Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the FDA had granted Rare Pediatric Disease Designation to VCA-894A, Vanda's investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare, serious, and progressive inherited neurological disorder. Vanda continues to progress the FDA formal hearing regarding HETLIOZ® for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the D.C. Circuit set aside the FDA's prior 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 in December 2026. GAAP Financial Results Net loss was $62.5 million (diluted loss per share of $1.04) in Q2 2026 compared with a net loss of $27.2 million (diluted loss per share of $0.46) in Q2 2025. Net loss was $111.1 million (diluted loss per share of $1.86) in the first six months of 2026 compared with a net loss of $56.7 million (diluted loss per share of $0.96) in the first six months of 2025. 2026 Financial Guidance Vanda is reiterating its 2026 total revenue guidance and expects to achieve the following financial objectives in 2026: Conference Call Vanda has scheduled a conference call for today, Wednesday, August 5, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 1843107. A replay of the call will be available on Wednesday, August 5, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, August 12, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 1843107. The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's expectations with respect to its ability to fund its operations through at least the end of 2027; the expected timing of the commercial launch of BYSANTI™ for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA's review of the Quimilza™ BLA for the treatment of GPP; Vanda's clinical development plans and expected timelines for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, HETLIOZ® in the treatment of DSPD, and BYSANTI™ for the treatment of MDD; Vanda's expectations with respect to its commercial expansion and ability to create value from its product pipeline; Vanda's expectations with respect to its operating expense run rate through 2027; the anticipated timing of the commencement of personal promotion of NEREUS™; Vanda's continued pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder and Vanda's expectations with respect to the HETLIOZ® evidentiary hearing; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; Vanda's ability to reduce its operating expenses, conserve cash and generate enough revenue to fund its operations through at least the end of 2027; Vanda's ability to successfully execute the commercial launch of BYSANTI™ for the treatments of bipolar I disorder and schizophrenia in the second half of 2026; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for Quimilza™ by December 12, 2026; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the Phase III studies for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, and HETLIOZ® in the treatment of DSPD and receive the respective study results by the end of 2026; Vanda's ability to complete the Phase III study for BYSANTI™ for the treatment of MDD and receive results in the first half of 2027; Vanda's ability to commence personal promotion of NEREUS™ for the prevention of vomiting induced by motion in 2026; and the outcome of the administrative hearing process for HETLIOZ® for the treatment of jet lag disorder. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified 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 Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact:Kevin MoranSenior Vice President, Chief Financial Officer and TreasurerVanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan MooreCollected [email protected] Follow us on X @vandapharma View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2026-financial-results-302844175.html

Interested in Vanda Pharmaceuticals Inc.? Here are five stocks we like better. Vanda reported Q1 2026 revenue of $51.7 million (up 3% YoY) driven by Fanapt (net sales up 26% YoY with prescriptions rising 32%), while HETLIOZ sales declined 24% due to generic competition; the company posted a net loss of $48.6 million, held $202.3 million in cash and equivalents, and raised 2026 revenue guidance to $240–290 million (including $10–30M from NEREUS). Vanda launched NEREUS nationwide via a direct‑to‑consumer site, setting a WAC of $255 per capsule with a cash‑pay offer around $85 (≈65% discount), and expects NEREUS to contribute $10–30 million in 2026, though management said this estimate is early and model‑based. The FDA approved BYSANTI (milsaperidone) with data exclusivity through Feb 20, 2031 and patents to 2044 and a planned commercial launch in H2 2026, while several late‑stage milestones are upcoming — Thetis Phase III (tradipitant) and VQW‑765 readouts by end‑2026, an imsidolimab PDUFA on Dec 12, 2026, and BYSANTI adjunctive MDD top‑line results in Q1 2027. Vanda Pharmaceuticals (NASDAQ:VNDA) reported first-quarter 2026 revenue of $51.7 million, a 3% increase from $50.0 million in the prior-year period, as growth in Fanapt was partially offset by continued declines in HETLIOZ amid generic competition. Management also highlighted the U.S. commercial launch of NEREUS through a direct-to-consumer platform and the FDA approval of BYSANTI, alongside several late-stage pipeline milestones expected to read out over the next 12 to 18 months. President, CEO, and Chairman Dr. Mihael Polymeropoulos said the quarter was marked by “strong commercial execution,” citing 26% year-over-year growth in Fanapt sales, the “groundbreaking U.S. launch of NEREUS,” and the FDA approval of BYSANTI (milsaperidone). → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Chief Financial Officer Kevin Moran reported Fanapt net product sales of $29.6 million in Q1 2026, up 26% from $23.5 million in Q1 2025, but down 11% from $33.2 million in Q4 2025. Moran attributed the year-over-year increase primarily to higher volume, “partially offset by a decrease in price net of deductions.” The sequential decline versus Q4 was attributed to lower volume and lower price net of deductions, which he said reflected “insurance plan disruptions and deductible resets that are typical in the industry at the beginning of the year.” Prescription metrics for Fanapt were also cited as key indicators of momentum: Q1 2026 total prescriptions (TRx) increased 32% year over year, according to IQVIA Exponent. New-to-brand prescriptions (NBRx) rose 76% year over year. Weekly TRx reached an 11-year high of more than 2,600 prescriptions for the week ending April 24, 2026, according to management. → A Prada Payday: Is AMC Back in Style? On channel inventory, Moran said Fanapt inventory at wholesalers was “slightly above four weeks on hand” at quarter-end, generally consistent with Q4 2025 but slightly above historic levels. In response to an analyst question about potential destocking, Moran said he would not expect it if Fanapt continues to grow, noting that the weeks-on-hand calculation can lag when demand is increasing. HETLIOZ net product sales were $15.9 million in Q1 2026, down 24% from $20.9 million in Q1 2025 and down 3% from $16.4 million in Q4 2025. Moran attributed the decline to reduced volume driven by “continued generic competition in the U.S.” He added that HETLIOZ sales can fluctuate due to inventory stocking patterns at specialty pharmacy customers and warned sales “may decline in future periods, potentially significantly,” as generic competition persists. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% PONVORY net product sales were $6.2 million, up 10% from $5.6 million in Q1 2025 but down 18% from $7.6 million in Q4 2025. Moran said the year-over-year increase reflected higher volume and improved price net of deductions, while the sequential decline was primarily due to lower price net of deductions. He noted that underlying patient demand was “essentially flat” versus Q4 2025 despite typical early-year insurance disruptions. Management emphasized the nationwide availability of NEREUS via the company’s direct-to-consumer site, nereus.us. Polymeropoulos described the model as a “patient-centric” approach intended to “eliminate traditional pharmacy barriers” with online ordering and direct delivery. He said the company views motion sickness as “a prototypical consumer product,” offering the medication in increments of two capsules, which may align with travel needs. Vanda raised full-year 2026 revenue guidance to include NEREUS for the first time, adding expected net product sales of $10 million to $30 million from the newly launched product. When asked about the breadth of that range, Polymeropoulos said it was “very early” and that the estimate was “more modeling” than experience-based. Moran similarly said the range is “not informed by actual data at this point,” but based on modeling and research; management expects to provide more context as the launch progresses. On pricing, Moran said NK1 antagonists can range from “the $200 range up to about the $600 range” per dose, and that Vanda’s strategy is “in the middle on the lower end.” Polymeropoulos said the wholesale acquisition cost list price is $255 per capsule, while the cash-pay offering is “about a more than 65% discount,” which he quantified as $85 per capsule through the direct-to-consumer model. Management also indicated it plans to pursue broad access, including insurance coverage over time, while focusing initially on cash pay. Polymeropoulos said BYSANTI was approved by the FDA for the treatment of bipolar I disorder and schizophrenia, and that it is protected by data exclusivity through February 20, 2031, with patents “the latest of which expires on May 31st, 2044.” Moran said the company remains on track to have BYSANTI commercially available in the “back half of the year.” He added that demand for BYSANTI is expected to be “independent of Fanapt,” and that where BYSANTI replaces Fanapt use, the company expects “meaningful net price favorability,” implying a higher revenue contribution per unit. In development, management pointed to several upcoming readouts and regulatory milestones: Thetis Phase III study of NEREUS (tradipitant) for prevention of vomiting in patients receiving GLP-1 receptor agonists, with results expected by the end of 2026. Polymeropoulos said the Phase III design is similar to a Phase II study that previously showed a “significant reduction in vomiting episodes,” but noted the short study will not directly answer adherence questions. Phase III study of VQW-765 in adults with social anxiety disorder, with results expected by the end of 2026. Phase III study of BYSANTI as a once-daily adjunctive treatment for major depressive disorder, with top-line results expected in Q1 2027. Polymeropoulos said the timing shifted from year-end 2026 due to updated recruitment projections and site additions, including in Europe. Imsidolimab BLA accepted by the FDA for generalized pustular psoriasis, with a PDUFA target action date of December 12, 2026. Polymeropoulos noted results from the pivotal study were published in the April 28, 2026 issue of New England Journal of Medicine Evidence. Regarding imsidolimab commercialization, Polymeropoulos said Vanda does not expect to launch “right after the PDUFA date” due to the complexity of monoclonal antibody manufacturing and indicated the company hopes to launch “within the first half of 2027.” He also said the proposed indication supports both acute flare treatment and maintenance dosing in responders. On a separate long-acting injectable iloperidone program in schizophrenia relapse prevention, Polymeropoulos said the study is recruiting slowly and that relapse rates on placebo appear to be declining across the field compared with prior years. He said Vanda plans to discuss the situation with the FDA and may modify the development plan. Vanda posted a net loss of $48.6 million in Q1 2026, compared with a net loss of $29.5 million in Q1 2025. Operating expenses were $101.9 million, up from $91.1 million a year earlier. Moran attributed the increase primarily to higher SG&A spending tied to commercialization efforts for Fanapt and PONVORY, launch preparation for NEREUS and BYSANTI, and higher legal expenses, partially offset by lower R&D spending on imsidolimab. Cash, cash equivalents, and marketable securities totaled $202.3 million as of March 31, 2026, down $61.5 million from December 31, 2025. Moran said the decline was driven by the quarterly net loss, a one-time $10 million milestone payment to Eli Lilly for NEREUS U.S. approval, seasonal compensation payments of about $7 million, and approximately $11 million of manufacturing payments. Excluding those items, he said the cash decline would have been “closer to $40 million.” For 2026, the company raised total revenue guidance to $240 million to $290 million (from $230 million to $260 million previously), reflecting the potential contribution of NEREUS while maintaining prior ranges for Fanapt and other products. Specific guidance items included: Fanapt net product sales: $150 million to $170 million. Other net product sales (HETLIOZ and PONVORY): $80 million to $90 million, assuming further HETLIOZ decline and modest PONVORY growth. NEREUS net product sales: $10 million to $30 million. Moran said the company is not providing 2026 cash guidance, but indicated it is “likely” cash burn will be higher than in 2025 due to ongoing investments. Vanda Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders and rare diseases. The company's research and development efforts center on sleep-wake regulation, mood disorders, and movement disorders. Vanda's mission is to address unmet medical needs by advancing novel molecules through clinical trials and regulatory review. Vanda's flagship commercial product is Hetlioz (tasimelteon), a melatonin receptor agonist approved by the U.S. The article "Vanda Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation." Financial Highlights Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025. Fanapt® net product sales were $29.6 million, up 26% year-over-year. HETLIOZ® net product sales were $15.9 million, down 24% year-over-year. PONVORY® net product sales were $6.2 million, up 10% year-over-year. Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant). Key Commercial Highlights Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. NEREUS™ is now commercially available nationwide through nereus.us, Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUS™ represents a breakthrough in both science and patient access. Key Regulatory & Clinical Development Highlights BYSANTI™ (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027. The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026. The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) 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 England Journal of Medicine (NEJM) Evidence2. Corporate Highlight On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent. GAAP Financial Results Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025. 2026 Financial Guidance Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other products: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8051722. The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, and VQW-765 in the treatment of adults with social anxiety disorder; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTM for the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the clinical study for BYSANTITM for the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified 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 Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2026-financial-results-302764640.html

Image source: The Motley Fool. Wednesday, May 6, 2026 at 4:30 p.m. ET President, Chief Executive Officer, and Chairman of the Board — Mihael H. Polymeropoulos Senior Vice President and Chief Financial Officer — Kevin Moran Kevin Moran: Thank you, Jordan. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals Inc.’s first quarter 2026 performance. Our Q1 2026 results were released this afternoon and are available on the SEC’s EDGAR system and on our website, 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 Mihael H. Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board. Following my introductory remarks, Mihael 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 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, Mihael. Thank you very much. Mihael H. Polymeropoulos: Good afternoon, everyone, and thank you for joining us today for Vanda Pharmaceuticals Inc.’s first quarter 2026 earnings conference call. Vanda delivered strong commercial execution in the first quarter, highlighted by 26% year-over-year growth in Fanapt sales, the groundbreaking U.S. launch of Nirius with its pioneering direct-to-consumer platform at nirius.us, and the FDA approval of Dysanti. We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation. Financial highlights. Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50 million in Q1 2025. Fanapt net product sales were $29.6 million, up 26% year-over-year. Full-year 2026 revenue guidance was raised to $240 million to $290 million, including $10 million to $30 million from newly launched Nirius. Commercial highlights. Fanapt saw continued strong momentum with total prescriptions (TRx) up 32% and new-to-brand prescriptions (NBRx) up 76% versus 2025. In April 2026, weekly TRx for Fanapt reached an eleven-year high of over 2.6 thousand prescriptions for the week ending 04/24/2026. Nirius is now commercially available nationwide through nirius.us, Vanda’s innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than forty years, Nirius represents a breakthrough in both science and patient access. Some key regulatory and clinical development highlights. Dysanti (milsoperidone) received FDA approval for the treatment of bipolar I disorder and schizophrenia. Dysanti is protected by data exclusivity through 02/20/2031 and multiple patents, the latest of which expires on 05/31/2044. Vanda’s ongoing late-stage clinical studies are progressing rapidly and are expected to generate top-line results in 2026 or early 2027, including the Phase 3 study of Dysanti as a once-daily adjunctive treatment for major depressive disorder with results expected in Q1 2027; the third Phase 3 study of Nirius for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies with results expected in 2026; and the Phase 3 study of VQW-765 in the treatment of adults with social anxiety disorder with results expected by 2026. The FDA accepted the Biologics License Application for imsidolimab in generalized pustular psoriasis, with a Prescription Drug User Fee Act target action date of 12/12/2026. The results of the pivotal clinical study were published in the 04/28/2026 issue of the New England Journal of Medicine Evidence. In summary, 2026 is developing into a transformational year for Vanda Pharmaceuticals Inc. with an extensive and diversified portfolio of commercialized products that include Fanapt, Hetlioz, Hetlioz LQ, Ponvory, Nirius, Dysanti, and potentially imsidolimab by year-end. Our recent innovative launch of Nirius through the nirius.us platform revolutionizes customer experience through a convenient ordering system at a significantly discounted cash-pay price. Finally, our late-stage pipeline, with several Phase 3 studies, is poised to further diversify our portfolio and strengthen Vanda’s commercial presence for years to come. With that, I will turn now to Kevin to discuss our financial results. Kevin Moran: Thank you, Mihael. I will begin by summarizing our first quarter 2026 financial results. Total revenues for Q1 2026 were $51.7 million, a 3% increase compared to $50 million for Q1 2025, and a 10% decrease compared to $57.2 million for Q4 2025. The increase as compared to Q1 2025 was primarily due to growth in Fanapt revenue as a result of continued commercialization efforts for Fanapt in bipolar disorder, partially offset by decreased Hetlioz revenue as a result of generic competition. The decrease as compared to Q4 2025 was primarily driven by the impact of insurance plan disruptions and deductible resets that are typical in the industry at the beginning of the year. Let me break this down now by product. Fanapt net product sales were $29.6 million for Q1 2026, a 26% increase compared to $23.5 million in Q1 2025, and an 11% decrease compared to $33.2 million in Q4 2025. The increase in net product sales relative to Q1 2025 was attributable to an increase in volume partially offset by a decrease in price, net of deductions. Fanapt total prescriptions, or TRx, for Q1 2026, as reported by IQVIA Xponent, increased by 32% compared to Q1 2025. Fanapt new patient starts, as reflected by new-to-brand prescriptions, or NBRx, for Q1 2026, as reported by IQVIA Xponent, increased by 76% compared to Q1 2025. The decrease in net product sales relative to Q4 2025 was attributable to a decrease in volume and price, net of deductions. Fanapt TRx for Q1 2026 decreased by 1% as compared to Q4 2025. The decrease in volume was primarily driven by the impact of insurance plan disruptions and deductible resets that are typical in the industry at the beginning of the year and that we have observed with Fanapt and the broader atypical antipsychotic market in prior years. Historically, Fanapt inventory at wholesalers has ranged between three and four weeks on hand, as calculated based on trailing demand. As of the end of Q1 2026, Fanapt inventory at wholesalers was slightly above four weeks on hand, generally consistent with the level of inventory weeks on hand as of Q4 2025, but slightly above the historic range. Turning now to Hetlioz. Hetlioz net product sales were $15.9 million for Q1 2026, a 24% decrease compared to $20.9 million in Q1 2025 and a 3% decrease compared to $16.4 million in Q4 2025. The decrease in net product sales relative to Q1 2025 and Q4 2025 was attributable to a decrease in volume as a result of continued generic competition in the U.S., which has contributed to declines in expenses for both comparative periods. Of note, for Q1 2026, Hetlioz continued to be the leading product from a market share perspective despite generic competition for over three years. Hetlioz net product sales can be impacted by changes in inventory stocking at specialty pharmacy customers from period to period. Hetlioz net product sales have fluctuated and may continue to fluctuate from quarter to quarter depending on when specialty pharmacy customers need to purchase again. Hetlioz net product sales may decline in future periods, potentially significantly, related to continued generic competition in the U.S. And finally, turning to Ponvory. Ponvory net product sales were $6.2 million for Q1 2026, a 10% increase compared to $5.6 million for Q1 2025, and an 18% decrease compared to $7.6 million in Q4 2025. The increase in net product sales relative to Q1 2025 was attributable to an increase in volume and price, net of deductions. The decrease in net product sales relative to Q4 2025 was primarily attributable to a decrease in price, net of deductions, partially offset by an increase in volume. The specialty distributor and specialty pharmacy inventory on-hand levels during these periods were in line with normal ranges. Of note, underlying patient demand was essentially flat between Q4 2025 and Q1 2026, even in light of the negative impact of insurance plan disruptions and deductible resets at the beginning of the year. Additionally, as we have previously discussed, an amount of variable consideration related to Ponvory net product sales is subject to dispute, of which approximately $3 million was recognized for the three months ended 12/31/2024. For Q1 2026, Vanda recorded a net loss of $48.6 million compared to a net loss of $29.5 million for Q1 2025. The net loss for Q1 2026 included income tax expense of $100 thousand as compared to an income tax benefit of $7.9 million for Q1 2025. As a reminder, the company recorded a one-time tax charge in 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 Q1 2026 were $101.9 million, compared to $91.1 million for Q1 2025. The $10.8 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 Fanapt in bipolar disorder and Ponvory in multiple sclerosis, expenses associated with the preparation for Nirius and Dysanti commercial launches, and higher legal expenses. These increases were partially offset by lower R&D expenses on our imsidolimab program, partially offset by an increase in expenses for our Dysanti major depressive disorder program, VQW-765 social anxiety disorder program, and other development programs. Q1 2025 included an upfront payment to Anaptys for the exclusive global license agreement for the development and commercialization of imsidolimab. On the commercial side, during 2024 and 2025, we conducted a host of activities as a result of the commercial launches of Fanapt in bipolar disorder and Ponvory in multiple sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. Additionally, in 2025, we launched our direct-to-consumer campaign, which has driven meaningful gains in brand awareness for the company and our products, Fanapt and Ponvory. Throughout 2025 and Q1 2026, we maintained 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. Vanda’s cash, cash equivalents, and marketable securities (referred to as cash) as of 03/31/2026 were $202.3 million, representing a decrease of $61.5 million compared to 12/31/2025. The decrease in cash was driven by the net loss in Q1 2026, as well as a one-time milestone payment of $10 million made to Eli Lilly in Q1 2026 for the approval of Nirius in the U.S.; seasonal compensation and benefit payments, which generally hit during the first quarter of the year, of approximately $7 million; and payments to third parties for manufacturing of commercial and clinical product of approximately $11 million, which is significantly higher than recent quarters. As a reminder, payments made in advance of production are capitalized as a prepaid expense. Commercial products are capitalized as inventory on our balance sheet after production, while pre-commercial products are generally expensed as research and development costs as incurred. The timing of manufacturing of pre-commercial products may result in future variability of our R&D expense, depending upon the timing of production. When adjusting the decrease in cash for these items, the change in Q1 2026 would have been closer to $40 million. With regard to the launches of Fanapt in bipolar disorder and Ponvory in multiple sclerosis, the launches were initiated in 2024, and we continue to enhance our commercial efforts through 2026, with the impact of these commercial efforts contributing to revenue growth in 2025 and expected to continue to contribute to our revenue growth in 2026 and beyond. We have already seen significant growth in our commercial activities. Several lead indicators suggest a strong market response to our commercial activities related to Fanapt for bipolar disorder, including total prescriptions (TRx) increased by approximately 32% in Q1 2026 as compared to Q1 2025. In April 2026, weekly TRx for Fanapt reached an eleven-year high of over 2.6 thousand prescriptions for the week ending 04/24/2026. New patient starts, as reflected by NBRx, increased by 76% in Q1 2026 as compared to Q1 2025. Of particular note, Fanapt was one of the fastest growing atypical antipsychotics in the market throughout 2025 and into 2026, based on several prescription metrics. Our Fanapt sales force continues to expand. Our Fanapt sales force numbered approximately 160 representatives at year-end 2024 and increased to approximately 300 representatives at year-end 2025. These expansions have allowed us to significantly increase our reach and frequency with prescribers. To that end, the number of face-to-face calls in Q1 2026 was more than 80% higher than the number of face-to-face calls in Q1 2025. In addition to our Fanapt sales force, we have established a specialty sales force to market Ponvory to neurology prescribers around the country and have grown this sales force to approximately 50 representatives. Fanapt 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 Dysanti. Before turning to our financial guidance, I would like to remind folks that with Fanapt, Hetlioz, Ponvory, and now Nirius already commercially available, and with Dysanti recently approved for bipolar disorder and schizophrenia, and a Biologics License Application for imsidolimab now under review by the FDA, Vanda has five products currently commercially approved and could have six products commercially approved by year-end 2026. Turning now to our financial guidance. Vanda is raising its full-year 2026 total revenue guidance to reflect the potential contribution of newly launched Nirius while maintaining prior ranges for Fanapt and other products. Vanda expects to achieve the following financial objectives in 2026: total revenues from Fanapt, Hetlioz, Ponvory, and Nirius between $240 million and $290 million. The midpoint of this revenue range of $265 million would imply revenue growth in 2026 of approximately 23% as compared to full-year 2025 revenue. This compares to previous guidance of total revenues from Fanapt, Hetlioz, and Ponvory of between $230 million and $260 million. Fanapt net product sales of between $150 million and $170 million. The midpoint of this range would imply Fanapt revenue growth in 2026 of approximately 36% as compared to full-year 2025 Fanapt revenue. This guidance is consistent with the previously communicated revenue guidance. Assuming consistent gross-to-net dynamics between 2025 and 2026, the bottom end of the range assumes high single-digit to low double-digit sequential quarterly TRx growth for Fanapt in the remainder of 2026. The top end of the range assumes mid-teens to high-teens sequential quarterly TRx growth for Fanapt in the remainder of 2026. Other net product sales of between $80 million and $90 million. This range assumes a further decline of the Hetlioz business due to generic competition and modest growth of the Ponvory business, where we are seeking to significantly improve market access to the product. Depending on our success in these efforts, we could see meaningful improvements in patients on therapy, prescriptions filled, and prescriptions written by prescribers. This guidance is also consistent with the previously communicated revenue guidance. Finally, Nirius net product sales of between $10 million and $30 million. This guidance was not previously provided and is being introduced as part of the Q1 earnings update. Vanda is currently making conditional investments to facilitate future revenue growth, both in the form of R&D investments, commercial manufacturing, and potentially outsized commercial investments, which could vary moving forward depending on the success of these commercial strategies. 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. With that, I will now turn the call back to Mihael. Mihael H. Polymeropoulos: Thank you very much, Kevin. At this point, we will be happy to answer your questions. Operator: As a reminder, if you would like to ask a question during this time, please press star followed by one on your telephone keypad. Your first question comes from the line of Olivia Brayer from Cantor. Your line is live. Olivia Simone Brayer: Hi. Good afternoon. Thank you for the question. Can you run through what the pushes and pulls are that you are using for that $10 million to $30 million guidance range for Nirius? It seems like somewhat of a big range given that it is so early in the launch, so I am curious what the higher end of the range assumes versus the lower end. And then on Dysanti’s launch, what is the progress on getting that to patients at this point? And should we assume that any contribution from Dysanti this year is essentially embedded in your Fanapt guidance, or is it just too early to start attributing revenues there? Mihael H. Polymeropoulos: Maybe, Olivia, I will start off by saying it is very early on the new launch, and you have seen that we are approaching it as a broadly available commercial product with a direct-to-consumer platform, which is in the early days. Of course, we are working through all the dynamics and logistics of that. We will have a better idea on progress by our next call. In terms of the $10 million to $30 million, we are excited about the opportunity. We know we are tapping a market of potentially 70 million people with motion sickness, and a good percentage of them suffering from severe motion sickness that is not properly treated today. The $10 million to $30 million is a relatively wide range, but it is not informed by experience; it is more modeling from the total market opportunity and other treatments for motion sickness. I will turn it to Kevin. Kevin Moran: That is right, Olivia. That is what is driving the range; it is not informed by actual data at this point. It is informed by modeling and what we have seen in some of our qualitative and quantitative research. As we gather more information, we will be able to provide additional context as the year progresses. On the Dysanti side, what we previously communicated is that we were looking to have the product available in the back half of the year, and that is still on track. We are working to bring that product to market. As far as the revenue contribution goes, it is still pre-launch, so a little early. I would not think about it as embedded in the Fanapt revenue item because we expect that we will see demand for Dysanti independent of Fanapt. For any demand that we see for Dysanti that replaces Fanapt demand, we are expecting to see meaningful net price favorability, which would lead to a larger revenue contribution from a Dysanti unit versus a Fanapt unit. Olivia Simone Brayer: Got it. So for Dysanti specifically, is it just a matter of waiting until it is officially commercially available before providing any sort of revenue numbers around that, or is 2026 maybe just a little bit too early to start modeling Dysanti? Kevin Moran: We have not committed to providing revenue guidance on Dysanti at a specific point in time, but the launch is going to be critical to us having better visibility. We will be looking to provide additional updates, and it is not necessarily too early depending on the time at which we launch the product. Olivia Simone Brayer: Okay. Thank you. Helpful. Operator: Thanks, Olivia. Your next question comes from the line of Raghuram Selvaraju from H.C. Wainwright. Your line is live. Raghuram Selvaraju: Thanks so much for taking my questions. First, I was wondering if you could provide us with some additional color regarding the timeline to reporting of top-line data for the tradipitant study assessing its ability to attenuate nausea and vomiting and other GI side effects associated with GLP-1 drugs. Kevin Moran: Thanks, Ram. In the press release today, we said results by the end of 2026, and our timing is consistent with what we communicated most recently in our initial launch of the program. We are actively enrolling patients at this point, so that timing is informed by actual activity. Raghuram Selvaraju: Can you talk a little bit about what your expectations are for that dataset—what you would consider to be a clinically meaningful result—and if you are also going to have additional information regarding the impact of tradipitant use on adherence and efficacy outcomes on the GLP-1s for patients enrolled in the study? Mihael H. Polymeropoulos: Thank you, Ram. First of all, the Phase 3 study is of a very similar design to the Phase 2 study for which we reported positive results in November. That is a week of pretreatment with tradipitant or placebo, and then a single injection of Wegovy at 1 mg and follow-on for another week. We aim to confirm the previous finding of the significant reduction in vomiting episodes. That was highly clinically meaningful. On your question about adherence, with this short study, we will not have that information. It is widely known that decreased GI tolerability, especially around dose escalation to higher doses, is a significant contributor to decreased adherence. Raghuram Selvaraju: Can you comment on the possibility or likelihood of any off-label use of tradipitant, given the fact that it is now an approved drug for motion sickness among those folks taking GLP-1 drugs, who may potentially have obtained them via some consumer health initiative, to assist them in achieving long-term adherence? Mihael H. Polymeropoulos: The keyword here is label. We cannot promote off-label use, especially when in the midst of clinical studies and certainly not before approval in that indication. We do not have insights to share on off-label use. We certainly hope that upon approval there will be significant interest. Raghuram Selvaraju: Last question for me is with respect to the long-acting injectable formulation of iloperidone. Can you provide us with an update on that and how rapidly you expect to be able to advance the product candidate at this juncture? Mihael H. Polymeropoulos: For context, this is the long-acting injectable iloperidone being used in a study to measure relapse prevention in schizophrenia. The study is ongoing in the U.S.; however, it is recruiting slowly. We think that is a phenomenon in the field with these studies and the required design of a placebo-controlled relapse prevention trial. We are concerned that this exact model that has worked extremely well for Fanapt oral and other antipsychotics is becoming less amenable to studying new drugs. We are thinking and potentially discussing with the FDA soon that not only is recruitment slower in the U.S. for this type of placebo-controlled schizophrenia relapse prevention study, but the rate of relapse on placebo has been significantly reduced compared to historical data. It is too early for us to say what the exact placebo relapse rate will be in this study, but we already believe it will be much lower than in our prior oral iloperidone relapse-prevention study. Together, these suggest concerns about timing and progress, but we have several ideas and plan to engage the FDA in a constructive discussion and perhaps modify the development plan. Operator: Your next question comes from the line of Madison Wynne El-Saadi from B. Riley. Your line is live. Madison Wynne El-Saadi: Hi, thanks for taking our questions. Maybe I will ask about the recent New England Journal publication on imsidolimab in GPP. We are looking at a potential Christmas-time approval again. Are you taking steps now to lay the groundwork for a potential year-end commercial launch? Would this likely be something where there is a one-quarter cushion before the launch? And is the expectation that you would receive approval in both the acute and the maintenance settings out of the gate? Mihael H. Polymeropoulos: Thank you very much, Madison. You are correct. We are very excited with the publication in a high-caliber journal, the New England Journal of Medicine Evidence, a testament to peer-review scrutiny around these impressive data. On indication, we believe that the data from the GEMINI-1 and GEMINI-2 studies support both immediate treatment of acute flares with a single injection and maintenance of response in responders with once-every-four-week injections. That is our proposed indication with the FDA. We are also making progress toward regulatory filings in Japan and in Europe, but they are much earlier than the FDA submission. In terms of launch timing, this is a complex product to manufacture, being a monoclonal antibody. We do not expect that we will be commercially launching right after the PDUFA date. There will be some lag time, but we hope we can launch within 2027. Madison Wynne El-Saadi: Understood. On the Fanapt prescription data and the reacceleration in April—Dysanti was approved late February—was there a halo effect, or was that purely the sales force you described? Kevin Moran: Thanks, Madison. Historically, including this year, we have seen the first quarter have seasonality with both Fanapt and the broader atypical class. This first quarter was no exception. In line with our expectations, we saw a flattish first quarter on prescription demand, consistent with last year and years prior. Last year, after the first quarter, we saw an acceleration and sequential quarterly growth in the double-digit range in the second, third, and fourth quarters. That is our expectation this year and is supported by what we see in the April data, which includes our highest TRx number in over eleven years—over 2.6 thousand. The pattern we have seen in prior years and expected to see this year has played out to date. Mihael H. Polymeropoulos: I agree, and also want to emphasize that the commercial infrastructure is mature. We have approximately 300 representatives, well trained and developing their relationships in the field, supported by a significant speaker program and our brand awareness direct-to-consumer marketing. Madison Wynne El-Saadi: Understood. Thank you. Operator: Your next question comes from Les Solisky from Truist. Your line is live. Les Solisky: Great. Thank you for taking my questions. First, on Fanapt, do you have a sense of what portion of the TRx and NBRx are coming from bipolar versus schizophrenia? And with inventory running above normal, should we expect any wholesaler destock in 2Q? And then on Dysanti, can you rank the launch priorities—new patient starts versus switches from Fanapt—and targeting Medicaid-heavy patients? And third, I see the MDD readout was moved to 2027 from year-end 2026. What drove the timing shift? And I have a follow-up. Thank you. Kevin Moran: Thanks, Les. On the split, while we do not analyze the data at an indication level, our expectation is that the primary driver of Fanapt growth is the bipolar label expansion we got in 2024. That has informed our targeting strategy, call points, and call guidance. As for stocking, historically we have seen Fanapt inventory levels at three to four weeks. At the end of Q1 2026, Q4 2025, and as far back as 2024, inventory levels were at or slightly above four weeks on hand. The inventory at the end of the first quarter is consistent with what we have seen recently and what we would expect for a product that is growing. Because it is measured off trailing demand, if demand is growing, the calculation lags. I would not expect a destock; I would expect inventory levels to maintain at this level as long as Fanapt continues to grow. On prioritization of new patients versus switches from Fanapt to Dysanti, we will prioritize both. Dysanti will be detailed as a newly approved atypical antipsychotic, and we will deploy commercial strategies to move appropriate prescriptions from Fanapt to Dysanti. With the Dysanti launch in the back half of this year and the potential Fanapt loss of exclusivity at the end of next year, we have about five quarters where both products will be in the market, enabling a switch strategy while executing a launch strategy as well. Mihael will address the MDD timing. Mihael H. Polymeropoulos: Les, you are correct. We moved the timing of end of study and results for the MDD study to 2027 from 2026. We are still working hard to get results as soon as possible; it could be by year-end. We have better data now on recruitment speed, especially bringing on new sites in Europe. It is a reflection of projections from the actual recruitment data. Les Solisky: Thank you. On commercialization in motion sickness, can you provide some color around patient access to the drug and how net pricing looks outside of the website via the retail pharmacy channel? Lastly, I am curious about your pricing strategy given the competing NK1s out there and how this would translate to the GLP-1 adjunct opportunity. Kevin Moran: Thanks, Les. As we look at the insurance reimbursement landscape, with the product relatively recently approved, that process will play out over coming quarters and years as payers conduct their clinical assessments and periodic reviews. We expect to have more information to share on Nirius access and progress as we move further into the launch. Securing coverage is something we would like to achieve in addition to the cash-pay model, but the cash-pay model is our immediate focus with the innovative platform we have deployed. On pricing strategy, in the competitive NK1 class, per-dose pricing ranges from about $200 up to about $600. Our pricing strategy positions us in the middle to lower end. With an eye toward gastroparesis and, if we are successful on the regulatory front, the GLP-1 market, we believe that pricing will be competitive for those patients as well. Considerations included having the appropriate price for the motion sickness market while anticipating potential gastroparesis and GLP-1 markets. Mihael H. Polymeropoulos: I would add that we chose this commercial model because we believe motion sickness is a prototypical consumer product. As you can see on our website, we provide the product in increments of two capsules, which may be enough to supply someone for their business or personal travel where they may experience motion. We are receiving good comments on being very patient-centric. While in recent years we have seen a cash-pay model at discounted prices emerge for drugs like GLP-1 analogs, this is the first instance we know of where you can directly coordinate with the manufacturer. This is an innovative system we have built at Vanda that works in conjunction with a mail-order pharmacy to get the product to patients expeditiously. We are also working to add value-added services, including a telemedicine platform so that patients can conveniently obtain prescriptions. It is focused on the customer experience, and we want this to be an example for others to follow. You mentioned other NK1 antagonists. Yes, there are other approved drugs in the class; none have been studied or approved in motion sickness or as an adjunct to GLP-1 therapy. The lead product there has been aprepitant by Merck in chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting. There are key label differences that can make Nirius more attractive for our consumer base, including the absence of interaction in the midazolam study, which differentiates Nirius from aprepitant, and aprepitant’s contraindication or warning around contraceptive use. Those and other items on the prescribing information, we believe, can make the product attractive for this approved indication. Les Solisky: Thank you. Just to clarify, would you consider a dual-model approach for the GLP-1 adjunct opportunity, meaning rolling it out with a DTC plan and a traditional insurance channel as well? Mihael H. Polymeropoulos: Our premise is broad access. Any way people want to acquire the product, we want to make it available. At the same time, we recognize the difficulties people are going through with the “middlemen”—pharmacy benefit organizations, plans, pharmacies—and price markups. There is a national discussion around that. The WAC price, the list price of $255 a capsule, is within the range of other NK1 antagonists. However, on cash pay, we are offering it at more than a 65% discount—from $255 to $85 a capsule—making it affordable for folks who travel for business or pleasure or engage in activities that cause motion sickness. We are also making the drug available to pharmacies and ensuring that wholesalers will either stock the drug or make it available upon demand. The premise is access, and access is not just insurance negotiations; it is appreciating independence and convenience by individual patients in accessing this drug. We think this dual model can achieve that. Operator: Your final question comes from the line of Andrew Tsai from Jefferies. Your line is live. Andrew Tsai: Hi. This is Faye on for Andrew. Thanks for the updates and for taking our questions. We have two questions. Number one is about milsoperidone. We want to gauge your views on its likelihood of success in the Phase 3 MDD trial. We know that not all antipsychotics work in MDD, so can you talk about your confidence in why milsoperidone should succeed, and is there any existing Fanapt data to support any of its benefits as an adjunct? Mihael H. Polymeropoulos: Yes, we are quite confident—that is why we are running this study, and we are running it with once-daily Dysanti. We think the study is properly powered to detect a clinically meaningful improvement in symptoms of depression. Generally, atypical antipsychotics are effective as an adjunctive treatment in major depression. The pharmacology includes dual dopamine and serotonin receptor antagonism and a strong, unique-in-class alpha-1 receptor antagonism. Whether that will be necessary to achieve the effect in major depression will remain to be seen, but we remain very confident in Dysanti’s ability to achieve the effect. Andrew Tsai: Thank you. The second question is for Nirius. It launched earlier this month, and you briefly touched on the pricing strategy. Can you talk about the sales cadence for this drug later this year moving into 2027? Mihael H. Polymeropoulos: With us launching mid–second quarter, we would expect revenue to grow as the year progresses, driven by the passage of time and the increase in our promotional activities. Operator: Thank you. There are no further questions. I would now like to turn it over to Vanda Pharmaceuticals Inc. management for closing remarks. Mihael H. Polymeropoulos: Thank you very much, all, for joining this call and for your questions. We look forward to talking to you soon. Operator: That concludes today’s meeting. You may now disconnect. Before you buy stock in Vanda Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Vanda Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $473,985!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,204,650!* Now, it’s worth noting Stock Advisor’s total average return is 950% — a market-crushing outperformance compared to 203% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 6, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Vanda (VNDA) Q1 2026 Earnings Call Transcript was originally published by The Motley Fool

Fanapt growth of 26% year-over-year was primarily driven by the 2024 bipolar I disorder label expansion, which management identifies as the key volume catalyst. The company launched Nirius via a pioneering direct-to-consumer (DTC) platform to bypass traditional pharmacy barriers and address a market of 70 million motion sickness sufferers. Management attributes the Q1 sequential revenue decline to industry-standard insurance plan disruptions and deductible resets rather than a shift in underlying demand. Strategic investments in the sales force, which grew to 300 representatives for Fanapt by year-end 2025 and 50 for Ponvory, contributed to the number of face-to-face calls in Q1 2026 being more than 80% higher than in Q1 2025. The commercial strategy for Dysanti focuses on capturing new patient starts and facilitating switches from Fanapt to leverage meaningful net price favorability. Hetlioz revenue continues to face pressure from generic competition, though management notes it remains the market share leader after three years of generic entry. Full-year 2026 revenue guidance was raised to $240 million to $290 million to incorporate the initial commercial contribution from the Nirius launch. Management expects 2026 cash burn to exceed 2025 levels due to outsized commercial investments and manufacturing costs for clinical and pre-commercial products. Top-line Phase 3 results for tradipitant in GLP-1-induced nausea are expected by the end of 2026, aiming to confirm prior Phase 2 findings on vomiting reduction. The PDUFA target action date for imsidolimab in generalized pustular psoriasis is set for 12/12/2026, with a commercial launch anticipated in 2027. Vanda’s ongoing late-stage clinical studies are progressing, with top-line results for the Phase 3 study of Dysanti as a once-daily adjunctive treatment for major depressive disorder expected in Q1 2027. A $10 million milestone payment was made to Eli Lilly in Q1 2026 following the U.S. approval of Nirius. Management expressed concern regarding the slow recruitment and declining placebo relapse rates in U.S. schizophrenia studies, potentially requiring a modified development plan for the long-acting injectable iloperidone program. Manufacturing payments of $11 million in Q1 2026 were significantly higher than recent quarters due to the timing of production for commercial and clinical supplies. A $3 million variable consideration related to Ponvory net product sales remains subject to an ongoing dispute. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management set a cash-pay price of $85 per capsule, representing a 65% discount from the $255 WAC to ensure affordability in the consumer-driven motion sickness market. The pricing strategy was designed to be competitive for motion sickness while maintaining flexibility for future high-volume indications like gastroparesis and GLP-1 adjunct therapy. Nirius is differentiated by a lack of interaction in midazolam studies and the absence of warnings regarding contraceptive use found in competitors like aprepitant. The product is being marketed in small increments (two capsules) to align with the specific needs of business and personal travelers. Inventory sits slightly above four weeks, which is above the historical three-to-four-week range but consistent with recent quarters. Management does not expect a destock, as current levels are viewed as appropriate for a product experiencing high double-digit prescription growth. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.