Vanda Pharmaceuticals Inc. (VNDA) Earnings Call Transcript & Summary

Good morning, everybody. Thank you so much for joining us on day 4 of the JPMorgan Healthcare Conference. My name is Bhavana Balakrishnan, and I'm an associate in the Healthcare Investment Banking Group. Today, we're joined by Vanda Pharmaceuticals, and we have with us Kevin Moran, Senior Vice President, Chief Financial Officer and Treasurer. Over to you, Kevin.

Wonderful. Thank you. And thank you very much to the entire JPMorgan team for having us here this week. So we'll begin our presentation first with our forward-looking statements that everyone should obviously review. So now turning to a company overview. Vanda Pharmaceuticals is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We focus on an innovation-led strategy where we have a decades-long track record of successfully developing and commercializing innovative therapies. We have a robust commercial portfolio that's anchored by 4 FDA-approved brands. Our 3 brands that are currently on the market, Fanapt, which is an atypical antipsychotic. HETLIOZ, which is approved for 2 orphan sleep disorders. PONVORY, which is approved in the neurology space for multiple sclerosis and our recently approved NEREUS approved in vomiting induced by motion. We have a strong debt free balance sheet, providing us with substantial capital to invest in our upcoming R&D and commercial activities. We have a late-stage growth pipeline with numerous high-potential programs targeting significant unmet needs in billion-dollar markets, both at the regulatory stage and late-stage clinical development. And we have a number of imminent regulatory catalysts including our recently approved NEREUS in motion sickness, all of which have potential for significant commercial expansion as early as this year. Turning now to our strategic focus. Our strategic focus is to grow and diversify our revenue, advance our pipeline, with all of which with a focus on consumers. So in our grow and diversify revenue strategy, we're planning on growing our revenue across our existing products and our current indications while diversifying that revenue with the potential to have 6 commercial products on the market by the end of 2026. In our pipeline, we have a number of programs in regulatory review with upcoming PDUFA dates. As well as a number of programs in the Phase III stage of development. In addition to that, we have multiple early-stage programs, including our emerging ASO platform. And one particular program to highlight is NEREUS, in addition to being approved recently in motion sickness, also had very positive Phase II results as a potential key adjunct treatment in the GLP-1 market. And finally, on our focus on consumers. We focus on large markets with high unmet patient needs, increasing access and affordability for patients and wherever possible, engaging directly with our customers and consumers. Focusing now specifically on our commercial therapies, beginning with Fanapt. Fanapt again, is an atypical antipsychotic. Our oral tablets are approved in the U.S. for the acute treatment of bipolar disorder in adults as well as schizophrenia. Our Fanapt long-acting injectable formulation currently is in Phase III for schizophrenia and we've initiated a program in hypertension. Finally, Bysanti, which is the active metabolite of Fanapt, our NDA has been accepted by the FDA for review, and we have an upcoming PDUFA date on February 21, 2026, so in a matter of weeks. In addition to that, we have a clinical program underway for major depressive disorder, MDD, where results are expected in 2026. HETLIOZ, our second product, the oral capsules are approved in the U.S. and in Europe for the treatment of non-24-hour sleep-wake disorder. And additionally, the oral capsules and the HETLIOZ LQ liquid formulation are approved in the U.S. for the treatment of Smith-Magenis -- nighttime sleep disturbances and Smith-Magenis Syndrome in adults and children. In addition to those indications, HETLIOZ is at the regulatory stage for both insomnia and jet lag disorder. And we have programs underway for pediatric insomnia, delayed sleep phase disorder and Pediatric Non-24-Hour Sleep-Wake Disorder. Our third product, PONVORY, is approved in the U.S. for the treatment of relapsing forms of multiple sclerosis. And there's IND applications, which have been accepted by the FDA in the treatment of psoriasis and ulcerative colitis, where we have Phase III programs ongoing. And finally, our recently approved product, NEREUS, which again is approved in the U.S. for the prevention of vomiting induced by motion. In addition to that, we have our Phase III program that we expect to start in the first half of 2026 for nausea and vomiting induced by GLP-1 and again, that program is imminently expected to start after we announced our results in November of 2025. And finally, NEREUS is also at the regulatory stage for the indication of gastroparesis. Now an overview of our recent and upcoming R&D milestones. So as I mentioned, NEREUS approved for motion sickness on December 30. And with that approval now in hand, we expect the commercial launch sometime in the second half of this year. On February 21, again, a matter of weeks, we have our Bysanti PDUFA date for both bipolar disorder and schizophrenia. In the first half of 2026, we expect to initiate our Phase III program for GLP-1 induced vomiting. In the second half of 2026, we expect to have a PDUFA date for our recently filed BLA for imsidolimab in the indication of generalized pustular psoriasis or GPP and then finally, our Bysanti Phase III program for MDD, we expect results in 2026. Here, we've got a more detailed overview of the portfolio of approved products and where they are in the pipeline phase. Just briefly, I'll touch on this. You can see the number of products that are -- at least all 4 products approved and in the market, Fanapt with the 2 indications of bipolar disorder and schizophrenia. HETLIOZ with the 2 indications of Non-24 and SMS. PONVORY with multiple sclerosis and NEREUS with motion sickness. And again, as you can see, the number of these programs that also are at the regulatory phase for additional indications as well as the Phase III and Phase IV programs that remain in development. Turning now to our early-stage pipeline. In addition to those assets that are already on the market, we have a number of other products that are at earlier stages of development. So we have VSJ-110 in the dry eye indication that's at Phase II, our VPO-227 product that's also at the Phase I stage for cholera. And then a particular note here is VQW-765, which is moving into Phase III for social performance anxiety. From a revenue perspective, we have a number of near-term revenue growth drivers as well as longer-term revenue growth drivers. So on the left side of the slide here, we can see our '25 to '27 commercial growth drivers. And then on the right side, the growth drivers that we expect in '28 and beyond. So with our currently approved products in the market on 2025 to 2027, plus the potential upcoming PDUFA dates, that will be driving our near-term growth. On a longer-term horizon, we see Bysanti and the potential indication of MDD as well as NEREUS in the potential indications of GLP-1 adjunct and gastroparesis. As potentially being very significant growth drivers for years to come. In a bit more detail here now on NEREUS. So as I mentioned, NEREUS approved for the indication of prevention of vomiting induced by motion. This is the first new pharmacologic treatment in motion sickness in over 4 decades. Our expectation is that this will be a premium prescription medication for those who either are unsatisfied with the current treatments for motion sickness and do not take them or those that take them and find them to be insufficient. In terms of market sizing, there's approximately 30% of adults in the U.S. or roughly 78 million people that experience symptoms during common travel modes such as cars, planes and boats. And of those 30% of adults, approximately 15% of that population experience symptoms significant enough that they seek treatment. That represents a potential patient population of roughly 12 million people in the U.S. In addition to that motion sickness opportunity, the opportunity for as an adjunct treatment in the rapidly growing $50 billion-plus GLP-1 market represents a very significant growth driver as we move towards our Phase III program. So what you see is nausea and vomiting is a very common symptom in the GLP treatment paradigm with discontinuation rates in the 30% to 50% range, many of which are due to these GI side effect profiles. Our randomized controlled study, the Phase II that had results in November of last year, met both the primary and secondary endpoints and demonstrated tradipitant NEREUS ability to significantly mitigate the GLP-1 induced nausea and vomiting. Our data, which we'll step through in a bit more detail on subsequent slide, showed approximately a 50% relative reduction in symptoms. It has a very favorable safety profile. By mitigating these side effects, tradipitant NEREUS could unlock much higher adherence rates for the rapidly growing market. And these results position tradipitant to potentially be a complementary and first-in-class adjunctive therapy for GLP-1 prescriptions. In a bit more detail on our study results. So the VP-VLY-686-2601 study had a primary endpoint of vomiting with a key secondary endpoint of vomiting and worst nausea greater than 3 on a 0 to 5-point scale. And as you can see in the primary endpoint in the placebo group, nearly 60% of our participants in the trial experienced vomiting compared to the tradipitant arm, which was less than 30%, and that represented a p-value of 0.0016. On the key secondary endpoint, again, of vomiting and worst nausea greater than 3 similar results in terms of the relative reduction. The placebo arm saw approximately 50% of folks that had a score worse than that or the tradipitant arm was closer to 20% that represented a p-value of 0.0039. Turning now to Bysanti, the latest on our program status there. In the bipolar 1 disorder and schizophrenia indications. Again, our NDA is under review. We've got a PDUFA target action date of February 21, 2026. A major depressive disorder. Our Phase III clinical study, again, expects results in 2026. And one keynote there is Fanapt and potentially Bysanti labels are BID. This Phase III program is being run as a once-daily adjunctive treatment for MDD. Now a bit more color on the overall psychiatry market. So with our currently approved Fanapt, which is approved in schizophrenia and bipolar disorder, the schizophrenia patient population in the U.S. is estimated to be approximately 3 million individuals with the bipolar patient population being much larger in the 10 million-plus range. The Bysanti PDUFA date on February 21 potentially would have us being approved in both of those indications as well. Whereas the Bysanti phase III program, if ultimately successful and able to be added to the label would open up the potential treatment option for Bysanti to an additional 20 million-plus patients that experience MDD. And what's commonly seen in this landscape is the ability to commercialize products only increases as you tap these markets, not both just because of the size of the relative markets, but also the relative receptivity to patients to commercialization efforts. Turning now to HETLIOZ. A brief update on our jet lag program status. So as a reminder, we received a CRL from the FDA back in August of 2019 related to our sNDA for HETLIOZ in the treatment of jet lag disorder. In 2025, we agreed on a collaborative framework with the FDA under which the FDA agreed to rereview our sNDA for jet lag by January 7. On January 7, the FDA concluded that the sNDA could not be approved in its current form. And we remain committed to working constructively with the FDA while pursuing all available paths to us to seek HETLIOZ for jet lag reaching the market as a critical treatment for these potential patients. Turning next to imsidolimab. So on imsidolimab, which we licensed from Anaptys early in 2025, the BLA for imsidolimab in the indication of generalized pustular psoriasis or GPP was submitted to the FDA in the fourth quarter of 2025. We requested a priority review and if granted, that could have us having a PDUFA date sometime in the summer of 2026. The supporting data underlying this BLA are 2 Phase III programs, the GEMINI-1 trial and the GEMINI-2 trial. In the GEMINI-1 trial, there was a rapid and clinically meaningful improvement of GPP obtained with single IV doses at the 300 mg and 750 mg dose level. In the GEMINI-2 trial, the maintenance dosing with every 4-week 200 mg dosages maintain clearance of GPP and prevented flares for at a minimum 24 weeks of follow-up. And in terms of the market size for GPP. GPP represents a significant unmet medical need. Prevalence estimates vary widely and vary by geographic region as well, ranging anywhere from 2 to 124 cases per million worldwide. The estimated patient population in the U.S. is somewhere less than 50,000 individuals. So obviously, an orphan indication where there still remains a significant unmet need. And imsidolimab, if approved, would be a single-dose IV, providing a predictable and seamless transition for patients to move directly from treatment in the acute rescue setting into long-term maintenance therapy. Turning now to our commercial highlights. So on Fanapt, as I mentioned, this product is approved in both the indications of bipolar disorder and schizophrenia. The bipolar approval was received in 2024. Following that approval, we expanded our commercial sales force in the third quarter of 2024 further expanding that in the middle of 2025. And beyond the commercialization efforts that we've taken in the bipolar indication, we continue to serve the needs of schizophrenia patients and providers. And what we've seen as a result of these significant commercialization efforts is very improved increased prescription demand during this period of time. So between the third quarter of 2024 and the most recently reported third quarter of 2025, we've seen 35% prescription growth in total prescriptions, 57% growth in new prescriptions or NRx and 147% growth in NBRx are new to brand prescriptions during that period of time. Turning now to HETLIOZ and PONVORY. On the HETLIOZ side, the reminder here is that generic competition entered the market at the end of 2022. Albeit that happening, HETLIOZ continues to be the market share leader despite this generic competition. We continue to see growth of HETLIOZ and HETLIOZ LQ in the SMS market in the U.S. And as I mentioned previously, we continue to pursue FDA approvals for HETLIOZ and other indications with jet lag disorder insomnia being the latest stage in terms of development. On the PONVORY side, PONVORY again indicated in the treatment of relapsing forms of multiple sclerosis now promoted in the U.S. in all 50 states. And what we've seen there is increased underlying patient demand between the first quarter of 2025 and the second quarter of 2025 as well as between second quarter and the third quarter of 2025. Turning now to our late-stage pipeline update. Again, as I mentioned on the Fanapt side, on our long-acting injectable, we have a Phase III program underway in schizophrenia. And in addition to that, we've initiated a Phase III program as well in hypertension. On the HETLIOZ life cycle management side, again, our jet lag disorder and insomnia disorder programs are completed, and we are continuing to pursue FDA approval and on our other programs, we have programs underway for delayed sleep phase disorder, Non-24 pediatric and pediatric insomnia. On our nearest life cycle management plans, as I mentioned, we have our vomiting induced by a GLP-1 analog program, where we had results reported in November, and we're initiating our Phase III program in the first half of this year. And on gastroparesis, we continue to pursue FDA approval for tradipitant in patients with gastroparesis. Finally, turning to our financial results. For the most recently reported period of the third quarter of 2025, we had revenue of $56.3 million, which consisted of Fanapt revenue of just over $31 million. HETLIOZ revenue of approximately $18 million and PONVORY revenue of approximately $7 million. And this consists with our guidance of total revenue guidance in 2025 of $210 million to $230 million and year-end 2025 cash guidance of $260 million to $290 million. With that, I think we can now turn to some questions.

All right. Thank you so much, Kevin. Thank you for the very comprehensive presentation. Maybe we start with some of your recent developments. And you did talk about your upcoming catalysts, which ones do you think are key and ones that you're most excited about?

Yes. So as we look at our upcoming catalysts and how we kind of view them on the Bysanti side, which again is the one with a PDUFA date in about a month, we view that as essentially foundational to the continuation of our base business. So Fanapt has an expected loss of exclusivity around the end of 2027. And so with the introduction of Bysanti potentially in the middle of this year, that will extend our broader psychiatry portfolio for many years to come, potentially out into the 2040s with patents that are pending. So the Bysanti opportunity, I would say, first and foremost, is kind of a foundational continuation. Then the potential to layer on an MDD label, in the Bysanti product obviously represents significant potential upside just given the relative size of the MDD market to both schizophrenia and bipolar. And then if that's kind of how you view the foundational with upside, then as you turn to NEREUS, we view the approval in the syndication of vomiting induced by motion. That actually being very potentially large just given the number of people that experience that condition and the limitations of current treatment options that are available. Many of the existing treatment options have varying side effect profiles, including drowsiness and sleepiness. And generally, if you're taking a medication to prevent motion sickness. It's not because you want to go to sleep, it's because you're trying to do something, right? And tradipitant's profile looks very advantageous from that angle. So we certainly think there's both a tremendous demand in the space and clearly an unmet need if patients have limitations on functioning while taking existing medications. And then potentially a transformative opportunity could be the adjunct therapy of NEREUS in the GLP-1 setting, just given the overall relative size of that market. The significant GI side effect profile that's seen in nearly all, if not all of the existing therapies and the effect that a treatment option like NEREUS could have on discontinuation rates, which are very high in the space in the range of 30% to 50% discontinuation rates, right? It's seen as a very common issue within the space for folks that are seeking this treatment. So that's kind of how we view them all -- and then there's others beyond that, but I would say those are kind of the most important from a kind of foundation perspective and then provide the most potential upside with both motion sickness being potentially very exciting as well as the potential in the GLP-1 space.

And maybe just quickly talking about Bysanti. How are you thinking about the commercial launch and sort of how would it work with your existing efforts with Fanapt?

Yes. So to remind folks, we have a very large sales force out detailing Fanapt right now in the neighborhood of about 300 reps. And prior to the approval for bipolar disorder, our sales force was primarily calling on psychs, right? But with the label expansion to include bipolar, we certainly have expanded our target universe to call on both psychs, but also potentially primary care docs as well. So we have a very well-built commercial infrastructure that's currently supporting Fanapt that could very easily be repurposed and repositioned to support Bysanti. So we feel very well situated from a commercial resource perspective to be able to support both brands. And as we potentially have Bysanti into the market, and have 6 quarters or so of overlap between when it is introduced to the market and when there could be a potential LOE on Fanapt, we certainly think we would, at the right kind of time and level, pivot our commercial activities towards Bysanti such that we can see that business kind of transition and continue beyond 2027. And one thing that's potentially important to highlight as part of that is from a net gross to net perspective, a net pricing perspective, Fanapt has been on the market for many years. And as a result of that, the gross to net that we see on Fanapt really includes no revenue contribution from Medicaid, and that's just due to time on the market and the way that those formulas are calculated. Bysanti as a new product under an NDA would get a pricing reset such that we would see a very meaningful improvement on gross to net and net pricing, meaning that if you have the same number of units in Bysanti that you currently have in Fanapt and WACC was the same, your net revenue would be much higher on Bysanti. So that's how we see kind of -- we're very well positioned commercially. There's going to be a transition strategy from one product to the other, but largely using the same resources that we currently have in place. And there's tremendous benefits both in the potential indication expansion to MDD, if we have positive results there, the potential for Bysanti moving to a once-a-day dose versus Fanapt in BID and these potential pricing benefits that we see by getting a reset with Bysanti.

Yes. And sticking to talking about Bysanti, how are you thinking about expansion in MDD and updates coming this year?

Yes. So we have our Phase III program underway. In our program, this is a fairly well-trodden space. So our clinical trial design is one that we think is consistent with what others have done, and therefore, we expect to be well positioned for discussion with the FDA from that end. So moving towards results this year. And then actually, if we have positive results, would look to move towards a regulatory filing soon thereafter and then potentially have it on the market in a few years in that indication. As you look across the space, the competitive landscape, the folks that have an MDD indication on their label are doing at a minimum, the same level of commercialization efforts, we are, if not even more. And so a label expansion there in a few years would represent both an opportunity for us to look to make sure we're rightsized from an investment perspective, but also represent potentially very significant revenue growth, just again, given that, that tends to be the largest market in the atypical antipsychotic space is the MDD market. So potentially a very significant opportunity for us a few years out if we're able to execute on positive data in the Phase III program.

Yes. And maybe switching gears to talk about in areas a little bit, and you did talk about it when you were talking about upcoming catalysts. What do you think the commercial opportunity in motion sickness looks like? And you also alluded about the excitement in the GLP-1 space. So if you could sort of like talk about both the commercial opportunities.

Yes. So maybe starting with the motion sickness opportunity, again, based on kind of the populations that we outlined there. It looks like there's in the neighbor of 10 million plus people that are seeking treatment in the U.S. for motion sickness. So obviously, again, a very large patient population. We'd expect from a pricing perspective, that our pricing would be at a premium relative to the existing treatment options, again, just given the product profile and the need. And then in terms of the commercialization and distribution strategy, we're going to look at making it available through as many avenues as possible, right? We want people to be able to access the medication in a way that's appropriate for them. But with the emergence of the DTP market and cash pay dynamics that have become much, much more prevalent in recent years. We think that NEREUS and motion sickness is a good candidate for that as well. Where patients can buy the product directly out of pocket rather than necessarily having to navigate insurance. We certainly will look to seek to have it be available via insurance for those appropriate patients, but also then have it be available and accessible for those patients that would like to just pay out of pocket to get it directly. So we think it's a very substantial market opportunity in the $100 million-plus range certainly and potentially even larger. As we look at the potential in the GLP-1 market, that could be significantly larger than that motion sickness opportunity just given the tremendous growth and continuing growth that we see in the GLP-1 space. And where motion sickness, you'd see NEREUS used on essentially an as-needed basis. There'd be some potential treatment paradigm with NEREUS and GLP-1 where it might be something that you take at initiation of treatment or at dose escalation where the incidence of nausea and vomiting are likely to be the highest. So I don't think it would be a companion product on an ongoing basis, but it will be used at intervals where it could be useful. So -- but again, just given the size of the market there and the incidents that you see of these type of side effect issues, again, we think that could be a potentially larger, maybe much larger market than even the motion sickness market.

And maybe to talk about imsidolimab a little bit. What are commercial efforts looking there?

Yes. So the reminder there is that we submitted the BLA at the end of last year and requested a priority review. So that could put us at an approval again sometime this summer, right? And if approved, likely a launch a couple of quarters after that, just given time to finish commercial packaging. From a commercialization effort perspective, this is an orphan patient population, who often present with a very acute flare in a hospital-type setting and so from a commercialization effort, as we're looking at it, we think of that more as an efficient orphan-type commercial model, unlikely to have a sales force or at least a large sales force, but very direct, dedicated, efficient commercial model. And we see the revenue opportunity there as being a very, I would say, strong contributor with a substantial market, albeit limited to an orphan patient population, where there's already another product Spevigo in the space that we think our product is going to have some differentiators to it that would make it potentially preferable, but the pricing is already pretty well established there at orphan pricing, and you see good access and reimbursement. So we think that's an efficient market that's more easily commercializable by us.

Well, thank you so much, Kevin, do you have any closing as we end up here? .

Yes. I would just say, incredibly excited for the progress that we've seen over the last 3 months. We had 3 products on the market and talking about having the potential to have 6 products on the market in a matter of months. As well as a number of very exciting clinical programs that have readouts over the next 6 to 18 months. So just a very exciting time for the company, lots of progress that we've seen over the last few months and a lot of exciting milestones and catalysts on a relatively near-term horizon. So very excited.

Well, thank you so much, Kevin.

Thank you so much. Thanks.