I'll walk us through the corporate presentation and then leave some time here for Andrew and I to have a bit of a Q&A. So obviously, folks should be aware of our forward-looking statements provision here in advance of going through these slides. So Vanda Pharmaceuticals is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercialized products: Fanapt, which is approved for bipolar disorder and schizophrenia. HETLIOZ and HETLIOZ LQ, which is approved in the U.S. for the capsule version for adults with Non-24-Hour Sleep-Wake Disorder and also adults with SMS.
The liquid LQ formulation is approved in the U.S. for pediatric patients with SMS, and HETLIOZ is approved in Europe for adults with Non-24-Hour Sleep-Wake Disorder. In addition to that, we have our recently acquired PONVORY, which is approved in the U.S. for multiple sclerosis, as well as Canada. In addition to those three commercial assets, we have a robust pipeline with a number of recent and upcoming regulatory submissions and multiple products across a wide range of therapeutic areas at various stages of development. Finally, we have a strong financial position with nearly $400 million of cash as of the end of the first quarter of 2024, with no debt. As I mentioned, in December of 2023, we completed the acquisition of PONVORY from Johnson & Johnson. PONVORY is approved in the U.S. and Canada for multiple sclerosis.
Recently, we announced that in May, we completed the transfer of the marketing authorization from J&J, which allows us to fully commercialize the product here in the U.S. Turning now to our commercialized products, as I mentioned, Fanapt is approved in the U.S. for the treatment of bipolar I disorder and for the treatment of adults with schizophrenia. We are also pursuing FDA approval for milsaperidone, which is the active metabolite of Fanapt, for the treatment of both bipolar disorder and schizophrenia, and we plan to submit an NDA to the FDA in early 2025. We also plan to commence a phase III program for the long-acting injectable formulation of Fanapt by the end of this year. Turning to HETLIOZ, as I mentioned, HETLIOZ oral capsules are approved in the U.S. and Europe for the treatment of Non-24-Hour Sleep-Wake Disorder. Oral capsules and the liquid LQ formulation are approved in the U.S. for the treatment of nighttime sleep disturbances in patients with Smith-Magenis Syndrome.
We continue to pursue FDA approvals of HETLIOZ in both insomnia and jet lag disorder. And then finally, our recently acquired PONVORY, which is approved for the treatment of multiple sclerosis, and where we recently announced that we plan to commence phase III studies of PONVORY in the treatment of both psoriasis and ulcerative colitis, with those programs expected to begin by the end of this year. On the clinical development pipeline side, a number of key milestones to highlight that have either already been completed or are planned in upcoming periods. So again, Fanapt was approved for bipolar disorder in April of this year. Milsaperidone, the active metabolite of Fanapt, is planned to be an NDA submitted in early 2025. On tradipitant, our PDUFA date for gastroparesis is upcoming in September of this year. And on motion sickness, we recently announced the results of our second positive phase III study, where we also expect to submit an NDA by the end of this year.
And then on the earlier stage side, for VCA-894A, we plan to enroll our patient in the study in the middle of this year. And for VSJ-110 on the dry eye indication, our phase II study is now over 50% enrolled. Strategic focus. Vanda's strategic focus is composed here in three areas. First is increased revenue, and that can be organically through our existing products in both the indications that they're already approved in, but also in future indications, as well as potentially pursuing additional business development opportunities. We plan to advance our pipeline, both our late-stage and early-stage programs, as well as continue to develop our early-stage ASO platform. And we have a focus on consumers, where we plan to increase access and affordability for patients wherever possible and engage directly with consumers. Turning to our commercial priorities and milestones.
Again, on Fanapt, we're focused on the launch of Fanapt in bipolar I disorder and continue to focus on the market for schizophrenia. In addition, we are planning on pursuing FDA approval for milsaperidone and continuing to develop the long-acting injectable formulation of Fanapt, where we plan to initiate our program by the end of this year. On the HETLIOZ side, we continue to focus on retaining market share for our existing patients while growing HETLIOZ in SMS in the U.S. market. We continue to pursue HETLIOZ in SMS in the European market, as well as pursue FDA approvals here in the U.S. for both insomnia and jet lag disorder. On PONVORY, we are focused on commercializing PONVORY in its existing indication of multiple sclerosis, as well as initiating phase III studies of PONVORY in both psoriasis and ulcerative colitis.
On tradipitant, we're focused on FDA approval for patients with gastroparesis, as well as continuing to focus on the advancement of our program in motion sickness. Turning now to our late-stage clinical development pipeline. As you noted here, we have a number of products in development across a wide range of therapeutic areas, which I'll step through in subsequent slides. On HETLIOZ, our jet lag disorder program and insomnia programs are both completed, and we continue to pursue legal and regulatory actions to advance those towards approval. On delayed sleep phase disorder, our phase III program has been initiated, and our Non-24 pediatric program is under preparation. Turning now to Fanapt. On our life cycle management activities, as I mentioned, we previously announced positive phase III study results in December of 2022, and we had FDA approval of Fanapt in bipolar in April of this year.
On the long-acting injectable formulation, we expect to initiate a phase III program by the end of 2024, where the Fanapt LAI could reach the U.S. market after 2026, and where there are pending patent applications that, if issued, could extend exclusivity into the 2040s. On milsaperidone, we expect to submit our NDA for milsaperidone, which previously has been called VHX-896 or P88, again, the active metabolite of Fanapt for both schizophrenia and bipolar I disorder to the FDA in early 2025. Similar to the long-acting injectable formulation, if approved, there are pending patent applications that, if issued, could extend exclusivity into the 2040s. Turning now to our tradipitant programs. As I previously mentioned, we continue to pursue FDA approval for tradipitant in patients with gastroparesis. Our NDA has now been accepted for filing, and our PDUFA date is upcoming in September of this year.
Previously, we reported our phase III study results in February of 2022. That was a 12-week study of approximately 200 patients with either idiopathic or diabetic gastroparesis. Prior to that, we reported positive phase II study results in December of 2018, which were published in Gastroenterology in January of 2021. On motion sickness, in May of this year, we reported our second positive phase III study results. That's on the heels of previously reported positive phase III study results in May of 2023 and our positive phase II study reported back in July of 2019. On gastroparesis, gastroparesis represents a very significant unmet medical need, with the last approved treatment option approved more than 40 years ago. There's estimated to be 6 million people in the U.S. with gastroparesis, about 600,000 of those being diagnosed.
For the only product approved for gastroparesis, metoclopramide, there's approximately 300,000 prescriptions on a monthly basis, all this underpinning the significant market opportunity for tradipitant in gastroparesis if approved by the FDA. Turning to the symptoms and clinical expression of gastroparesis, diabetic and idiopathic gastroparesis are characterized by chronic nausea, where patients suffer from chronic, severe, and debilitating nausea, vomiting, which can lead to weight loss and hospitalization, delayed gastric emptying, as well as additional GI symptoms, including early satiety and fullness. On our overall clinical program, as previously reported, we had a phase II study, the 2301 study, of approximately 150 adult patients treated for four weeks, where tradipitant was shown to be effective in improving nausea and the overall symptoms in patients with gastroparesis.
Following that, we had our phase III study, the 3301 study, which was a 12-week study of approximately 200 adult patients with diabetic or idiopathic gastroparesis. And while this study did not meet its primary endpoint, when accounting for confounders, there was strong evidence of drug effect across a number of symptoms. Finally, our expanded access program, where we initiated an expanded access program for patients requesting access to tradipitant outside of the clinical programs, and where we continue to receive requests from patients to gain access to tradipitant through the expanded access program, and now where multiple patients have been on tradipitant for over two years. On our motion sickness program, nausea and vomiting are the core symptoms of motion sickness, and the sensory mismatch resulting from motion sickness is due to the discordance between the actual and expected movement as perceived by various bodily symptoms.
For the only analog most closely observable for the market opportunity for motion sickness, there's approximately 2 million-3 million doses of dramamine purchased in the U.S. each month. Turning now to our phase III program. As I mentioned previously, our first phase III program was completed in May of 2023, and our second phase III program was completed in May of 2024, where both studies were positive in preventing vomiting. The first phase III study included about 365 randomized patients, and the second phase III included 316 randomized patients. On the first phase III study, the 365 participants were included in 34 boat trips on coastal waters off the U.S. from November of 2021 to April of 2023.
And in the incidence of vomiting, which was the primary endpoint, was significantly lower in tradipitant at approximately 18% for the 170 mg dose and approximately 19% for the 85 mg dose, as compared to placebo, where it was approximately 44%. In the second phase III study, we had 316 participants across 20 boat trips, again in the coastal waters off the U.S., which took place from September of 2023 to April of 2024. Again, the incidence of vomiting was significantly lower in tradipitant, with the 170 mg arm having approximately 10% vomiting, the 85 mg arm 18% vomiting, and that again compared to placebo with about 38% vomiting.
Briefly on our financial results, our Q1 financials included approximately $48 million of revenue, which consisted of a little less than $21 million from Fanapt, a little more than $20 million from HETLIOZ, and approximately $7 million from our recently acquired PONVORY. In the first quarter of 2024, we had, again, about $48 million of revenue, $57 million of OpEx, leading us to about a $4 million net loss and ending the quarter with a little more than $390 million in cash. With that, I'll now turn to Andrew for a few questions.
Okay, thanks, Kevin. Maybe a high-level question is, you do have $400 million in cash right now after spending some on PONVORY. What is the goal and strategy for you in terms of cash? Is it to preserve it, to grow it as you're developing more programs and getting them through the goal line? Maybe talk about that.
Yeah, yeah. I think as we kind of highlighted in our Q1 earnings release, we're very excited about the possibilities of both a Fanapt commercial launch and a PONVORY commercial launch. Obviously, with those commercial investments comes the possibility of commercial spend, with the goal being that we would see a return in the form of revenue in future periods. We're well capitalized in terms of our $400 million in cash to execute against our clinical and commercial plans, as well as to continue to potentially be opportunistic if there's an asset that we come across that we think could be synergistic for our operations.
I see. So you won't stop here in terms of BD? You will be?
Well, I would say that we would maintain the same perspective that we've always had, which is we always diligently evaluate opportunities that are out there. If something were to present itself that we thought could be of significant value creation for us and for our expertise and capabilities, we would certainly consider it.
Makes sense. And so maybe we start with Fanapt. You recently got the bipolar indication. Congratulations. Within schizophrenia, I think it's doing $90 million a year?
Approximately, yeah.
How much do you think overall sales can grow with this bipolar expansion?
Yeah.
Why?
Yeah. So when we look to the market, first in terms of where we think the trajectory could go and then the why. On where we think it could go, as we look across the market and other analogs in the market, the bipolar space is a significantly larger space than the schizophrenia space in terms of revenue opportunity. And so we certainly think that as we look at others, we've seen multiples referenced of 2x, 3x, 4x in terms of the magnitude of the opportunity for a bipolar indication relative to schizophrenia. And we certainly don't see any reason why Fanapt couldn't have a similar experience as those products, right? And then in terms of the why, unfortunately, the atypical class is a class without a silver bullet, right? There's no treatment option that is a fit-all solution for all of those patients.
It's a very high-switch class where patients and prescribers need a number of options depending on what works well for one patient versus another. It's also a very promotionally sensitive class. So folks that are out in the space active tend to see a result from the productivity of their activities. And so for both of those reasons, we also think Fanapt can perform very well as it's very similar to a lot of the products that are in the space in terms of efficacy and safety and is more a sense of effort and productivity relative to being a product limitation.
Right. So you do think sales can inflect?
Yes, absolutely.
Right.
Yeah.
Okay. You expect to submit the P88, milsaperidone compound, active metabolite Fanapt, I think was it later or if not by early 2025?
Early 2025, yeah.
Yeah. How does this product profile differ from Fanapt, if at all?
Yeah. So the first thing with milsaperidone, where it differs, is it's got the ability to be developed in the existing indications that Fanapt is in. But in addition to that, the potential for it in a long-acting injectable formulation comes with specific chemical properties that could allow for it to be less frequently dosed than Fanapt and other compounds, meaning it could be developed for something to be taken once a quarter or twice a year, right? And so beyond the potential for it as an oral formulation, the potential for it as a long-acting injectable formulation could differentiate it both from Fanapt and other products in the class.
I see. Let's just say it did get approved. How do you switch your existing Fanapt patients to this? What would the messaging exactly be?
Yeah.
How do you get new patients onto milsaperidone relative to Fanapt?
Yeah. So first of all, Fanapt wouldn't be something that wouldn't be available to patients ever. It's going to be something that would be available for all time. So less so focused on switching patients from Fanapt as much as it is making milsaperidone a part of the treatment paradigm for prescribers in the space and promoting it to prescribers so that they're aware of it and its potential treatment options.
Okay. What percentage of patients do you think would be amenable to an LAI or long-acting injectable?
Yeah. So I think that there's at least two different kind of cohorts of patients that could benefit from a long-acting injectable formulation. It's both those that have difficulty with compliance, right, where taking a once-a-day or twice-a-day medication is difficult for them in any setting, right? And the introduction of something that can be taken once a month, once every quarter or twice a year presents the opportunity for a significant benefit, right? So those patients. And then also, I would say more in general, these types of injectable treatment options have become more acceptable by the broader patient community in terms of with a lot of the treatment options that are out there, folks I don't think find them as kind of daunting.
And so I think just for the general patient who's looking for convenience and kind of a steady distribution of drug, it could also be a treatment option for them kind of more holistically.
Well, then shifting gears to PONVORY, which you recently acquired.
Please, yeah.
Q1 sales, I believe, were $6.8 million. So what can you do that J&J could not do?
Yeah. So just as a little bit of table setting, if you looked at our audited financial statements that we included in our 8-K that was required as part of the acquisition, PONVORY was doing about $30 million annualized in the 12-month kind of run into our acquisition. So not really any different than what we saw in the first quarter, right? So what we've seen there is kind of a nice stabilization of a foundational revenue and patient base. To start with, the first thing we would do is actually promote the product actively because J&J had essentially, for their own internal reasons, kind of ceased support of the product towards the end of 2022, right? And prior to that, they were seeing continuous volume growth from their activities.
So at a minimum, we think reinitiating those activities, which had led to success, but then also optimizing and refining those based on the PONVORY-specific profile can lead to resumption of revenue growth in future periods and for years to come.
How big can PONVORY be under your guys' launch?
Yeah. So again, we haven't provided guidance to that figure, but similar to as we look at other products that are in the space, many of our competitors that are in the space and have been in the space for not a dissimilar period of time are doing significantly higher multiples than PONVORY was doing. And the products themselves are not dramatically differentiated from PONVORY. If anything, PONVORY may also have some advantages over those products. And their commercial efforts also, while very effective, aren't necessarily incredibly novel in terms of a reasonably sized but dedicated sales force, prescriber awareness programs, and some supportive marketing efforts. So we think with similar efforts, we can see significant growth, hopefully oriented towards what other folks have been able to do in the space.
I see. You do plan to file multiple INDs for other indications for PONVORY. Do you go directly to phase III studies?
We do, yeah. So for the two indications that we are actively pursuing, the first one is ulcerative colitis. And within the class, we've seen two of the more recent market entrants for the S1Ps, one that's indicated for both MS and UC, but one that's actually only indicated for UC that actually are very similar to PONVORY, even within the S1P class, where we think there's a high degree of probability that we could replicate the clinical and regulatory success that we've seen with those products with the initiation of a phase III program. And then separately from that, J&J had actually produced wonderful phase II data in psoriasis that we also think very well could be replicated in a phase III program. And we're ready to commence both those programs by the end of this year.
Okay. And so you're expanding Fanapt for bipolar, PONVORY's launching, and then soon tradipitant could be approved. So how many sales reps do you need to hire to launch all three products?
Yeah. So as a reminder, prior to the generic introduction on HETLIOZ, we had had a little over 100 reps detailing on our neuroscience sales force and about 24 reps detailing HETLIOZ on our PDP initiative. So in the neighborhood of about 150. On our Fanapt dedicated sales force for the bipolar launch, we're initiating it in that same neighborhood of about 150 reps, right? So fairly consistent with what we had had prior to the generic launch. On the PONVORY side, where again, it's a smaller specialty sales force dedicated to focusing on writers of PONVORY, S1Ps, and other high-value neurologists, we think that's more in the neighborhood of about 30. So a much smaller given just given the nature of the call point. And then tradipitant remains to be seen, right?
Obviously, we'll be dependent upon the FDA decision later this fall, but I think it would follow a similar nature, more so akin to PONVORY than what you would see on the Fanapt side.
I see. And just to be clear, the HETLIOZ sales reps are around 150. That goes to the bipolar?
Yeah. So on Fanapt and HETLIOZ, there's 150 in total. There's no longer separate sales forces. There's just one sales force that details both products.
I see. Okay. And so tradipitant could be approved later this year. Walk us through why Vanda is confident it will be approved.
Yeah. I would more give you kind of the development path that we've seen over the last few years, which was, as I mentioned in my presentation, we had our phase III data readout where we missed on the primary endpoint, but when accounting for confounders and looking at a pooled analysis, we feel very confident in the efficacy of tradipitant and gastroparesis. In addition to that, we submitted an alternative data package as it relates to the nine-month dog toxicity study. Our package was accepted last year with a PDUFA date of September, right? But that being said, we'll have to see what the FDA's decision is based on that data. We are very confident in the efficacy of our product, but we'll have to wait and see what the FDA decides.
I see. So if you do get approval, what kind of label would you get? Would it be for the maintenance or just the chronic treatment of gastroparesis, or could there be a narrow label claim?
Yeah. Again, it's difficult to predict what the FDA could do on that. I'm sure that as with all things, all options are possibilities, but we'll just have to continue to see what their decision is and if approved, what the labeling would look like.
Okay. And then on the motion sickness, congrats on the positive phase III data sets. You're filing later. Was it Q4?
Yeah, Q4 of this year.
Yeah. So let's say it was approved, how applicable or what's the total addressable market? Because studies were done at sea.
Yeah.
Can this be used on planes? Any type of motion sickness?
Yeah. So the indication that we would be pursuing would be as it relates to motion, not necessarily specifically which vehicle you were in for the purposes of that motion. The addressable market is potentially significant, right? Given that there's estimates out there that as much as a third or more of the U.S. population suffers from motion sickness at varying degrees of severity, right? And for the most relevant data point that's out there in terms of a commercial product that's available, dramamine over the counter sees 2 million-3 million doses per month, just suggesting how large the actual use is of products to prevent or reduce the impact of motion sickness. So obviously, we think it's a very significant market opportunity given the potential impact of the U.S. population and the amount of utility that we currently see with available options.
I see. And why would someone use your product over dramamine?
Yeah. On other products, I won't necessarily comment specifically on any other product, but on other products, there can be negative side effects in terms of drowsiness or other residual effects. Tradipitant's safety profile doesn't seem to have any of those as significant side effects. Functionality of an individual could be significantly improved relative to existing treatments.
Okay. I think that's all the time we had. So thanks so much for the discussion and thanks everyone for tuning in.