Operator: Thank you for standing by. My name is Jordan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q1 2026 Vanda Pharmaceuticals Inc. earnings conference call. 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, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Vanda Pharmaceuticals Inc.’s Chief Financial Officer, Kevin Moran. Please go ahead.

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.

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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.

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