管理層發言
Good afternoon, and welcome to the Second Quarter 2026 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.
Thank you, Frans. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 2026 performance. Our second quarter 2026 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this 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 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.
Good afternoon, everyone. Thanks for joining us today for Vanda Pharmaceuticals' second quarter 2026 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 2026, a December 12, 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 complete launch preparations and commercial manufacturing, we expect operating expenses to begin moderating later this year and more significantly in 2027. We believe that our current resources together with anticipated product revenues provide a solid foundation to advance our objectives through at least the end of 2027. 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 2026 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 2027. Fanapt showed continued strong momentum in the second quarter of 2026 with total prescriptions (TRx) up 31% and new-to-brand prescriptions (NBRx) up 32% versus the second quarter of 2025. Since commercial expansion following the approval of Fanapt for bipolar I disorder, Fanapt has seen significant growth with TRx up 62% and NBRx up 300% versus the second quarter of 2024. BYSANTI received U.S. Food and Drug Administration approval for the treatment of bipolar I disorder and schizophrenia in the first quarter of 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 as a direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. 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 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-765 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; and the phase 3 study of BYSANTI as a once-daily adjunctive treatment for major depressive disorder with results expected in the first half of 2027. The Biologics License Application (BLA) for Imsidolimab 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 earlier on April 28, 2026, in the New England Journal of Medicine. In May 2026, we announced that Japan’s Ministry of Health, Labour 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 adopted 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 (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 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. With that, I will turn now to Kevin to discuss our financial results. Kevin?
Thank you, Mihael. I will begin by summarizing our financial results for the first six months of 2026 before turning to discuss the second quarter of 2026. Total revenues for the first six months of 2026 were $102.2 million, essentially flat as compared to $103 million for the same period in 2025. The first six months of 2026 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 2026. Total revenues for the first six months do not include approximately $7 million of HETLIOZ revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Let me break this down now by product. Fanapt net product sales were $65.5 million for the first six months of 2026, a 24% increase compared to $52.8 million in the same period in 2025. This increase in net product sales relative to the first six months of 2025 was 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 six months of 2026, a 42% decrease compared to $37.1 million in the same period in 2025. The decrease was attributable to a decrease in volume as a result of continued generic competition in the U.S. and the timing of shipments to customers at the end of the second quarter of 2026. HETLIOZ net product sales for the first six months of 2026 do not include orders totaling approximately $7 million in revenue that were shipped on June 29 and arrived on July 1. Those orders will be recognized as revenue in the third quarter of 2026. During the second quarter of 2026, 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 2026, HETLIOZ continued to be the leading product from a market share perspective despite generic competition for over three years. Turning to PONVORY. PONVORY net product sales were $14.1 million for the first six months of 2026, 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 is subject to dispute, of which approximately $3 million was recognized for the three months ended December 31, 2024. And finally, turning to NEREUS. NEREUS became commercially available in the U.S. in May 2026. NEREUS net product sales were $1 million for the first six 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 six months of 2026 primarily related to units sold through the wholesaler channel. During the second quarter of 2026, there was an initial stocking of NEREUS by wholesalers of $15.2 million. We constrained 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 U.S. in the second quarter of 2026 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 six months of 2026, 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 six months of 2026 included income tax expense of $300,000 as compared to an income tax benefit of $15.6 million for the same period in 2025. As a reminder, the company recorded a one-time, non-cash income tax charge in the fourth quarter of 2025 to establish a valuation allowance against all of Vanda's deferred tax assets. Tax expense is expected to be nominal going forward until such time that a valuation allowance is no longer required. Operating expenses for the first six months of 2026 were $216.3 million compared to $182.8 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-765, Fanapt, and BYSANTI programs, partially offset by lower expenses on our Imsidolimab program. The first six months of 2025 included an upfront payment to AnaptysBio for the exclusive global license agreement for the development and commercialization of Imsidolimab. 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 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 2026 as compared to the first quarter of 2026 was driven by the net loss in the second quarter of 2026, excluding the impact of non-cash charges such as stock-based compensation and amortization of our intangible and right-of-use assets, as well as timing of cash received from customers for revenue and related payments of rebates to payers, 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 one-time milestone payment of $10 million made to Eli Lilly in the first quarter of 2026 for the approval of NEREUS in the U.S. As a reminder, payments made in advance of production are capitalized as 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 Imsidolimab program, may result in future variability of our R&D expense and cash payments. Turning now to our quarterly results. Total revenues were $50.5 million for the second quarter of 2026, a 4% decrease compared to $52.6 million for the second quarter of 2025, and a 2% decrease compared to $51.7 million in the first quarter of 2026. The decreases as compared to the second quarter of 2025 and the first quarter of 2026 were 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 2026, partially offset by growth in Fanapt revenue as a result of the bipolar commercial launch. Revenues for the second quarter of 2026 do not include approximately $7 million of HETLIOZ revenue for orders shipped on June 29 that arrived on July 1. Let me now break this down by product. Fanapt net product sales were $36 million for the second quarter of 2026, a 23% increase compared to $29.3 million in the second quarter of 2025, and a 22% increase compared to $29.6 million in the first quarter of 2026. Fanapt total prescriptions (TRx), as reported by IQVIA Xponent, in the second quarter of 2026 increased by 31% compared to the second quarter of 2025 and 11% compared to the first quarter of 2026. The increases to net product sales relative to the second quarter of 2025 and the first quarter of 2026 were primarily attributable to increases in volume. Fanapt new patient starts in the second quarter of 2026 as reflected by new-to-brand prescriptions (NBRx) increased by 32% compared to the second quarter of 2025 and by 10% compared to the first quarter of 2026. Historically, Fanapt's inventory at wholesalers has ranged between three and four weeks on hand as calculated based off trailing demand. As of the end of the second quarter of 2026, Fanapt's inventory at wholesalers was slightly above four weeks on hand, generally consistent with the level of inventory weeks on hand as of the first quarter of 2026 and the fourth quarter of 2025, but slightly above the historic range. Turning to HETLIOZ. HETLIOZ net product sales were $5.6 million for the second quarter of 2026, a 66% decrease compared to $16.2 million in the second quarter of 2025, and a 65% decrease compared to $15.9 million in the first quarter of 2026. The decrease in net product sales relative to the second quarter of 2025 and the first quarter of 2026 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 2026 do not include orders totaling approximately $7 million in revenue that were shipped on June 29 and arrived on July 1. Those orders will be recognized as revenue in the third quarter of 2026. As mentioned in the discussion of results for the first six months of 2026, 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 2026, 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 2026, an increase of 12% compared to $7.1 million in the second quarter of 2025 and an increase of 27% compared to $6.2 million in the first quarter of 2026. 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 PONVORY net product sales is subject to dispute, of which approximately $3 million was recognized for the three months ended December 30, 2024. And finally, turning to NEREUS. NEREUS became commercially available in the U.S. in May 2026. NEREUS net product sales were $1 million for the second quarter 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 second quarter of 2026 primarily related to units sold through the wholesaler channel. In the second quarter of 2026, there was an initial stocking of NEREUS by wholesalers of $15.2 million; we constrained NEREUS 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, NEREUS launched commercially in the U.S. in the second quarter of 2026 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 second quarter of 2026, Vanda recorded a net loss of $62.5 million compared to a net loss of $27.2 million for the second quarter of 2025. The net loss for the second quarter of 2026 included income tax expense of $100,000 as compared to an income tax benefit of $7.7 million for the second quarter of 2025. Operating expenses in the second quarter of 2026 were $114.3 million compared to $91.1 million in the second quarter of 2025. The $23.2 million increase was primarily driven by higher R&D expense related to our VQW-765 and NEREUS 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 PONVORY in multiple sclerosis, the NEREUS commercial launch, and the 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, these launches were initiated in 2024, and we continue to enhance our commercial infrastructure in 2026, 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 in coming periods. We have seen significant growth in our commercial activities, including several lead indicators suggesting a strong and continued market response to our commercial activities related to Fanapt for bipolar I disorder. Total prescriptions (TRx) increased by approximately 31% in the second quarter of 2026 as compared to the second quarter of 2025. In May 2026, a weekly TRx number for Fanapt reached an 11-year high of over 2,700 prescriptions. New patient starts as reflected by NBRx increased by 32% in the second quarter of 2026 as compared to the second quarter of 2025. Since the commercial expansion following the approval for bipolar I disorder, Fanapt has seen significant growth with TRx up 62% and NBRx up 300% as compared to the second quarter of 2024. Of particular note, Fanapt is one of the fastest-growing atypical antipsychotics in the market throughout 2025 and into the second quarter of 2026 based on several prescription metrics. Our Fanapt sales force expanded to approximately 300 representatives in the second half of 2025. This expansion has allowed us to significantly increase our reach and frequency with prescribers. To that end, the number of face-to-face calls in the second quarter of 2026 was more than 30% higher than the number of face-to-face calls in the second quarter of 2025. Fanapt performance remains the focus of our commercial initiatives and encourages us to invest in this differentiated medicine and the franchise extending launch of BYSANTI in the second half of 2026. Before turning to our financial guidance, I would like to remind folks that with Fanapt, HETLIOZ, PONVORY, and now NEREUS already commercially available and with BYSANTI recently approved for bipolar I disorder and schizophrenia, and a Biologics License Application for Imsidolimab now under review by the FDA, Vanda could have six approved products by the end of 2026. 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 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. Fanapt and BYSANTI net product sales of between $150 million and $170 million. The midpoint of this 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 million to $90 million. And finally, NEREUS net product sales of $10 million to $30 million. Note that NEREUS launched commercially in the U.S. in the second quarter of 2026 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. 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 NEREUS, 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 2026 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 2027. With that, I will now turn the call back to Mihael.
Thank you very much, Kevin. At this point, we will be happy to answer your questions. Thank you.
分析師問答
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. Your first question comes from Raghuram Ram Selvaraju from H.C. Wainwright. Please go ahead.
Hi. Thank you for taking my question. This is Lin Tsai, sitting in for Ram. I have two questions. The first is with respect to the NEREUS launch experience. I am curious, with about three 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 2026 will finish near the low or the high end of the $10 million to $30 million range? Thank you so much. And one more about HETLIOZ. Following the July 20 pre-hearing conference and the August 3 evidentiary disclosure deadline, what became clear about the hearing overall? Which issue is most likely to drive the outcome? Do you think it would be something like interpretation of sites from the 3.1k and 3.11k endpoint validity? Or something else?
Yeah. Thanks for the question, Lin. As we look at the NEREUS 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, we will be initiating personal promotion with our salesforce, which we expect to support the activities that we are seeing out there in the field. As far as metrics go, for what folks should be looking for, I think that 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 are 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 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. On the second question regarding HETLIOZ, I will let Mihael and Daniel address the details around the hearing and process.
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?
Yes, that is right. And so, obviously, it is never a good idea to speculate about the outcome of litigation or litigation strategy, but 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 hoping obviously for a favorable recommendation from the judge early in 2027.
Your next question comes from Madison El-Saadi from B. Riley Securities. Please go ahead.
Hi. Thanks for taking our question. A couple from us. Maybe sticking with the NEREUS campaign: what exactly does the personal promotion start look like? 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 OpEx coming down later in 2026 and into 2027, is that more related to R&D or SG&A? And then what drove the Q2 R&D expense? Thanks.
Yeah. Thanks, Madison. So first on the NEREUS launch side, as we have spoken about before, we have a salesforce to support our Fanapt franchise in the neighborhood of approximately 300 representatives, as well as a salesforce in the neighborhood of 50 supporting our PONVORY efforts. We will be using some element of those two salesforces to be detailing NEREUS in the future. It is yet to be determined exactly what the structure is, but we have sufficient resources between those two teams to reach the prescribers that we are looking to reach. On your second question around what we are seeing from an expense trajectory perspective: as we have gone through 2025 and 2026, we now have multiple phase 3 programs set to read out either before the end of the year or early in 2027. We have three potential launches with NEREUS, BYSANTI, and, potentially, in the future, Imsidolimab. The cost of running those phase 3 programs is not insignificant, and the commercial production to ensure we have sufficient supply for the launches is also a significant investment. So as we have now reached or are reaching the end of those activities with the readouts of the clinical trials and the launch materials either made or being made shortly, those will be driving the most significant reductions in operating expenses as we head towards the end of 2026 and into 2027. And Madison, to the second part of your question, the significant increase in R&D operating expenses during the period was the ramp up of those programs that have reached or are reaching their conclusions shortly. Also, for products that are not yet approved, namely Imsidolimab, any of the production activities associated with making that inventory are expensed as incurred to R&D. That is an accounting treatment: you can capitalize inventory once the product is approved, whereas prior to approval you generally expense it as R&D, and it would hit our R&D line item. Those are the significant drivers in the current period.
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.
Thank you very much all for joining. I am sorry—oh, do we have another question? Sorry.
We do actually have a follow-up coming from Lin Tsai from Jefferies. Would you like to take the question?
Yeah. Please, let Lin in.
Okay. Go ahead.
Can you hear me okay? Great. Thanks so much. On the VQW-765 program, I was hoping you could talk about your prior phase 2 data and what exactly gives you confidence that you could succeed in phase 3 and maybe even why efficacy could look even better in phase 3? Thanks. Great. And then maybe one more if I can: I am wondering if you could talk about your filing strategy or potential timing for the GLP-1–induced vomiting indication for NEREUS. And then second to that, have you aligned with the FDA on the Phase 3 trial design? And what do you hope to see relative to the Phase 2 findings?
Thanks for the question. The phase 3 study that we are running now is similar in design to the phase 2 study, with a similar setup and similar primary endpoint. We have reported prior results there with two observations: one, a significant effect in reducing anxiety measures in that setting, and two, an 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 minimal changes in the design, no change in the dose, but an increase in the size of the study to be powered according to the learnings from the phase 2 study. 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 a design that used an advanced dose without any titration. The results showed that while approximately 60% of the people on placebo vomited in that design, only about 30% of the patients on NEREUS did so, showing significant protection. The current phase 3 design is a similar design where we aim to confirm the prior findings. We believe this body of evidence, alongside the broader NEREUS experience for the approved product, will suffice for the filing of a supplemental NDA. We continue to communicate with the FDA on the statistical analysis plan for this study and will continue those conversations as results become available.
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.
I thank you all for your questions, and thank you for joining this call. Thank you.
Ladies and gentlemen, thank you all for joining, and that concludes today's conference call. All participants may now disconnect. Thank you.