Hello, everyone. My name is Joseph Walsh, and I'm with JP Morgan. It's my pleasure to introduce Kevin from Vanda. Before we get started, just a heads up, we won't be holding Q&A at the end. With that, Kevin, go ahead.
Thank you very much, and thank you to the entire JP Morgan team for having us this week. Very excited to speak to you about recent developments with the company and our upcoming milestones for 2024. Looking at our forward-looking statements, investors should be familiar with our forward-looking statements and the risks associated with Vanda stock. Vanda Pharmaceuticals is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We now have three commercialized products with our recent acquisition of PONVORY, which I'll touch on in greater detail as we step through the presentation. Our commercialized products include HETLIOZ, which is both the oral capsule formulation of HETLIOZ, as well as the liquid LQ formulation. Additionally, we have Fanapt, and now with our acquisition, we have PONVORY as well.
In addition to those commercialized products, we have a very robust pipeline with multiple products across a wide range of therapeutic areas and a number of recent regulatory submissions and upcoming milestones for the next year. In addition to that, we're in a strong financial position with nearly $490 million of cash as of the end of the third quarter of 2023, with no debt, and this is prior to our acquisition of PONVORY in the fourth quarter. Beginning now with our recent acquisition of PONVORY from Johnson & Johnson. In December, we announced that we'd acquired the U.S. and Canadian rights to PONVORY from J&J for a $100 million upfront payment. PONVORY is approved in the U.S. by the FDA and by Health Canada in Canada to treat adults with relapsing forms of multiple sclerosis.
In addition to that, the mechanism of action for PONVORY also makes it a potential therapeutic candidate for the treatment of a diverse group of inflammatory and autoimmune disorders, including but not limited to psoriasis and ulcerative colitis. In terms of exclusivity, the PONVORY Orange Book listed patent with the latest expiry date is set to expire in December 2035. Now, a few things I would note about the acquisition of PONVORY and specifically the profile of PONVORY itself. It's a highly selective S1P1 receptor modulator, which means that PONVORY binds with high affinity to the S1P1 receptor. It's got proven results with the first and only DMT to show phase III head-to-head superiority versus another oral product. And it's got the ability to pause if needed, with one-week drug elimination, which is the fastest lymphocyte recovery in the S1P1 class.
So very excited about the possibilities for PONVORY, both in the approved indication of multiple sclerosis as well as the possibilities in a host of other indications. Now in a bit more detail about our commercial products. Again, our HETLIOZ oral capsules are approved in both the U.S. and Europe for adults with non-24-hour sleep-wake disorder. In addition, in the U.S., the oral capsules are approved for adults with nighttime sleep disturbances in Smith-Magenis Syndrome, and the liquid LQ pediatric formulation is approved for the pediatric population of nighttime sleep disturbances in Smith-Magenis Syndrome in the U.S. In addition to those indications, we're pursuing a number of other approvals for HETLIOZ in the U.S., the most proximal of which is insomnia, where our sNDA has been accepted for filing with a PDUFA date in the first quarter of this year. Turning now to Fanapt.
Fanapt is approved in the U.S. for the treatment of adults with schizophrenia. In addition to that, we're pursuing a number of other indications, most proximal of which is bipolar disorder, where we had positive phase III results at the end of 2022, and our filing, our sNDA, has now been accepted for filing by the FDA with a PDUFA date in April of this year. And now with PONVORY. Again, PONVORY indicated for the treatment of relapsing forms of multiple sclerosis, and with the potential to treat a number of other indications across the inflammatory and autoimmune disorders, ranging from, but not limited to, psoriasis and ulcerative colitis. Now, key recent milestones from a clinical and regulatory perspective. Again, we have three filings now accepted by the FDA with PDUFA dates in 2024.
HETLIOZ first in insomnia, with the sNDA accepted for filing with a PDUFA date in March. Fanapt with the sNDA accepted for filing in bipolar, with a PDUFA date in April. And finally, tradipitant, with the new drug application accepted for filing with a PDUFA date in September. In addition to those upcoming regulatory readouts, we've also had a number of other clinical developments and regulatory developments on the potential horizon. So for tradipitant in motion sickness, our phase III program had positive results in May of 2023, and we've now initiated a second phase III study. VHX-896, which is the active metabolite of iloperidone, which we also refer to as P88. We continue to work on our bioequivalence program, and there's the potential for an upcoming NDA filing in that potentially as early as this year.
And in addition to that, we've received orphan drug designation for two of our products, VCA-894A, which received orphan drug designation for Charcot-Marie-Tooth disease, and VPO-227, which received orphan drug designation for cholera. Vanda's strategy is focused on three topics: increasing revenue. First, we're focused on increasing revenue organically through our existing products, both in the indications that they're already approved in, as well as the potential for lifecycle management opportunities, including our sNDA filings, as well as beyond that. In addition, we continue to focus on business development opportunities, including our recent PONVORY transaction, but we continue to kind of survey the landscape and evaluate potential opportunities and beyond. In addition to increasing revenue, we're focused on advancing our pipeline.
We have late- and early-stage development programs across a wide range of therapeutic areas, as well as our emerging ASO platform, which we continue to develop. And finally, a consumer focus. Vanda's focused on increasing access and affordability for patients and engaging directly with patients wherever possible. Our upcoming commercial priorities and milestones. For Fanapt, we continue to be focused on the market for Fanapt and schizophrenia in the U.S., while continuing to pursue our FDA approval for the potential label expansion into bipolar later this year. And from a Fanapt franchise perspective, we continue to develop VHX-896 with a possibility of an upcoming NDA filing for that product, as well as the long-acting injectable formulation. On HETLIOZ, we're focused on retaining market share despite generic competition through a focus on consumer engagement and patient loyalty.
We're continuing to focus on growth for HETLIOZ in the U.S. and the SMS indication, specifically in the pediatric patient population, where there's no generic on the market. We're focused on obtaining SMS approval in the European market and continuing to pursue FDA approvals beyond the existing indications, and again, the most proximal of which is insomnia with our upcoming sNDA date. On PONVORY, we're focused on relaunching PONVORY and its existing approved indication of multiple sclerosis, as well as evaluating the potential to take it into additional therapeutic areas across a diverse group of inflammatory and autoimmune disorders, again, ranging from psoriasis to ulcerative colitis, but not limited to those.
Finally, with tradipitant, with our upcoming PDUFA date in September of this year, we continue to be focused on the possibilities of tradipitant being on the market in the very near future, as well as continuing to advance our motion sickness program. A bit more detail on Fanapt for schizophrenia. It's estimated that there's approximately three million people in the U.S. living with schizophrenia, representing approximately 1% of the adult population. Patients with schizophrenia are frequently treated with antipsychotic treatments and switch commonly due to the side effect profiles of those treatments. The side effects can range from metabolic weight and movement disorders to akathisia. Akathisia, frequently seen with a number of antipsychotics, whereas Fanapt has placebo-like akathisia side effect profile.
Akathisia is one of the most common side effects seen with these medications, with up to 25% of patients treated with some antipsychotics experiencing akathisia. On HETLIOZ for Non-24-Hour Sleep-Wake Disorder or Non-24. In the U.S., HETLIOZ is indicated for Non-24, regardless of visual acuity. So in the blind population, it's estimated that approximately 70% of folks that are totally blind are impacted by Non-24, whereas the patient population within the sighted community is less well understood, but appears to be rare. Non-24 in the sighted community is often seen as being comorbid with depression or bipolar disorder. The hallmark of Non-24 is a misaligned circadian timing system that presents itself in a number of ways from a clinical perspective, but most commonly, disrupted nighttime sleep, excessive daytime sleepiness, and poor social and occupational functioning. Turning now to HETLIOZ for Smith-Magenis Syndrome.
Again, HETLIOZ was approved for nighttime sleep disturbances in Smith-Magenis Syndrome at the end of December of 2020, and it was immediately available for adults, given that the oral capsule formulation was already on the market. The liquid LQ formulation came on the market soon thereafter, in the beginning of 2021. SMS is a rare genetic disorder where it's seen in about one in 15,000 to one in 25,000 births in the U.S. It's caused by either a chromosomal deletion or a rare genetic mutation, and it's characterized by major physical and developmental features, the most prominent of which often is severe sleep disorder.
Upon approval, we immediately began focusing on converting clinical patients to commercial supply, as well as working with the main advocacy organizations in the space, the primary of which is PRISMS, to make additional families aware of the potential treatment option being available for their family members. We then turned to working with diagnosis and tertiary care centers to educate them on the disorder and the potential treatment option. Finally, we began a targeted direct-to-consumer advertising campaign focused on individuals with MS and their families to make them aware of the potential treatment option. Turning now to our research and development activities. On the screen here, you can see our late-stage clinical development pipeline, and I'll briefly touch on some of these before stepping through them in a bit more detail on subsequent slides.
So again, on HETLIOZ, we're pursuing a number of different label expansions, potentially, but the most proximal of which is insomnia, again, with our sNDA date upcoming in March. On Fanapt, we're focused also on a number of label expansions, but again, the most proximal of which is our PDUFA date for bipolar I disorder in April this year, and our continued development of the long-acting injectable formulation. Skipping to the bottom of the slide, VHX-896 or P88, again, the active metabolite of iloperidone or Fanapt. We continue working on our bioequivalence efforts, and see the potential to submit an NDA as early as this year for P88.
On PONVORY, our recently acquired S1P receptor modulator, we are evaluating which indications potentially to pursue PONVORY in, but it's, t here's a wide and diverse range of therapeutic options that we could pursue PONVORY in. And then finally, tradipitant. Again in gastroparesis, we're now at the regulatory stage with our PDUFA date set for September of this year and our motion sickness program with its second phase III currently ongoing. Now, turning to a bit more detail on our HETLIOZ lifecycle management programs. On jet lag disorder, our clinical program is completed, and we continue to pursue FDA approval for jet lag disorder. On insomnia, our clinical program is completed as well, and our sNDA is now accepted, with the PDUFA date set for March 4. And our delayed sleep phase disorder and Non-24 pediatric programs continue. On a bit more detail on our Fanapt lifecycle management programs.
Again, our bipolar I disorder program, we had our positive results reported at the end of 2022, and our FDA filing has now been accepted for review with a PDUFA date in April. Our long-acting injectable formulation remains under development, where we're finalizing and optimizing dosing and administration. And on P88, again, we're working on our bioequivalence efforts and look towards a potential filing later this year. A bit more detail on our bipolar I disorder results. Again, the results were reported in December of 2022. The phase III study enrolled approximately 400 volunteers with a history of bipolar I disorder, suffering from a current episode of mania. The primary endpoint assessed was YMRS, a commonly used rating scale for clinical severity and the core symptoms of mania. And looking at the YMRS change from baseline at week four, Fanapt was significantly superior to placebo.
The secondary endpoints, CGI-S and CGI-C, also achieved statistical significance at week four. And of note, bipolar disorder is highly prevalent in the United States, estimated to affect approximately 3% of the U.S. adult population, a number which could be approximately up to 10 times higher than the estimated prevalence of schizophrenia. And as a reminder, our current revenue from Fanapt is generated for our current indication, of adults suffering from schizophrenia, and so the bipolar market could represent a significant opportunity for Fanapt in future periods. Turning now to our tradipitant programs. Beginning with gastroparesis, again, our phase III study results were reported in February 2022. This was for a 12-week study of approximately 200 patients with either idiopathic or diabetic gastroparesis. This followed our phase II positive study results, reported in December 2018 and published in Gastroenterology.
Again, we now have our FDA filing accepted for review with a target action date of September 18. On motion sickness, our phase II positive study results were reported in July 2019. That was followed by our first phase III study, which had positive results reported in May 2023, and we've now commenced our second phase III study. A bit more detail on gastroparesis. Gastroparesis itself is estimated to impact approximately 2% of the U.S. population, roughly 6 million people. Of those, approximately 600,000 have been diagnosed with gastroparesis, and the only approved treatment option, brand name Reglan or generic metoclopramide, which was approved over 40 years ago, sees approximately 300,000 prescriptions on a monthly basis.
This represents obviously a significant market opportunity given the prevalence of the condition in the space and the very limited treatment options and the high unmet medical need amongst the patients. The symptoms and clinical expression of gastroparesis. Diabetic or idiopathic gastroparesis are characterized by chronic nausea, where patients suffer with chronic, severe, and debilitating nausea; vomiting, which can lead to weight loss and hospitalization; delayed gastric emptying, where a mechanical defect can delay gastric emptying and potentially be the cause of some of the underlying symptoms the patients experience; and other GI symptoms, including fullness or abdominal pain. In a bit more detail on our clinical program, our phase II study, the 2301 study, was a four-week study of approximately 150 adult patients with diabetic or idiopathic gastroparesis.
In the study, tradipitant was shown to be effective in improving nausea and overall symptoms in patients with gastroparesis, and the efficacy established in the 4-week double-blind phase continued in the open-label phase. The phase III study, our 3301 study, was a 12-week study of approximately 200 adult patients with diabetic or idiopathic gastroparesis. While the study did not meet its primary endpoint, when accounting for confounders, there was strong evidence of drug effect across a number of symptoms. The open-label phase portion of the study remains open, and there's already been over 300 patients enrolled. Finally, our expanded access program for patients requesting access to tradipitant outside of the clinical studies continues to receive requests from patients and now has multiple patients having received tradipitant for more than 1 year.
The phase II study itself, again, a four-week study, followed by an optional 8-week open-label treatment period, was run across 47 sites in the U.S., with approximately 150 subjects randomized, stratified across idiopathic and gastroparesis, with a number of assessments, including the patient-reported daily diary, which was the primary endpoint. The phase III study, with a number of similarities, was a 12-week study across 40 sites in the U.S., with a slightly higher patient population, approximately 200 randomized subjects, again stratified across idiopathic or diabetic gastroparesis, with largely the same assessments. At the completion of the phase III study, we completed a pooled analysis of the two clinical studies, the 2301 and the 3301 studies of tradipitant and gastroparesis.
The population of the pooled analysis included 342 patients in key clinical parameters, and both studies of note were large, multi-site, randomized, double-blind, placebo-controlled studies. In this pooled study analysis, tradipitant was shown to be superior to placebo in key clinical parameters, including the daily diary nausea, the primary endpoint parameter. The conclusion is that both studies demonstrate the efficacy of tradipitant in relieving symptoms of gastroparesis. Turning now to our motion sickness program. Motion sickness is characterized by nausea and vomiting as the core symptoms of motion sickness. The sensory mismatch resulting in motion sickness is due to discordance between the actual and expected movement as perceived by various bodily symptoms.
Of note, the most commonly used treatment option for motion sickness, Dramamine, sees approximately two to three million doses purchased each month in the U.S., again, demonstrating the significant need for treatment options. Our phase II study results, which were reported in July of 2019, showed tradipitant to be effective in preventing motion sickness. As part of the study, an exploratory analysis was performed to evaluate tradipitant under both calm and rough seas. Under rough sea conditions, or sea conditions above one meter, approximately 72% of the placebo-treated patients vomited, as compared to approximately 16% of those treated with tradipitant.
A significant effect was also observed under rough sea conditions in the motion sickness severity worst score scale. On our phase III program, the phase III study randomized approximately 365 patients and was, including three arms, an 85 milligram arm, a 170 milligram arm, and a placebo arm. The second study includes a similar design, and our intended program timeline with our results on the first phase III reported in May of 2023, is a second phase III study being initiated that's currently ongoing, and then our intent to pursue FDA approval upon the completion of the clinical development program.
Again, the phase III study included 365 participants across 34 boat trips in coastal waters off the U.S., primarily off the coast of California or in the New England, New York area, from November of 2021 to April of 2023. The patients were randomized between the 170 mg tradipitant arm, the 85 mg tradipitant arm, and the placebo arm, one hour prior to departure. The boat trips themselves were approximately 4 hours, with questions of vomiting and nausea completed every 30 minutes. The incidence of vomiting was significantly lower in the two tradipitant arms as compared to the placebo arm, with the tradipitant arms being approximately 18%-19% vomiting, as compared to the placebo, which saw approximately 44% vomiting. Turning now to our early-stage programs.
Our CFTR programs include VSJ-110, our CFTR activator, which has shown efficacy in a dry eye model and is currently in an ongoing phase II conjunctivitis study, investigating the anti-inflammatory effect of VSJ-110 following a ragweed ocular challenge. VPO-227, where, as I previously mentioned, we were recently granted orphan drug designation by the FDA for the treatment of cholera. In addition to our CFTR programs, we have our hematologic malignancy program, our VTR-297, an HDAC inhibitor, currently in an ongoing phase II study in hematologic malignancies at sites in both the U.S. and Europe. Finally, VQW-765, where we had a phase II study reported in 2022, of a single-dose treatment to alleviate social performance anxiety. Finally, on our early-stage programs, our ASO platform.
In September of 2022, Vanda and OliPass Corporation announced a research and development agreement to jointly develop a set of ASO molecules based on OliPass's proprietary technology. As mentioned, VCA-894A was granted orphan drug designation, and this evolving discovery and development platform is intended to support Vanda's development of ASO precision-based medicine in the future. Finally, turning to our financial results. We've reported through Q3 of 2023 for our financial results. For the third quarter of 2023, we had net product sales of approximately $39 million. That consisted of HETLIOZ's net product sales of approximately $17 million and Fanapt net product sales of approximately $21 million.
For the full year through September 30, 2023, so the nine months ended, we had approximately $147 million of revenue, with approximately $154 million of operating expenses, and taking into account other income and other items, a net income of $5 million year to date through the first three quarters. As noted, we ended the third quarter with approximately $490 million of cash, no debt, but prior to the completion of the PONVORY transaction. With that, I'd like to thank everybody for their interest in Vanda. Look forward to talking to you as 2024 progresses about our commercial milestones on our recently developed PONVORY and other products, as well as our upcoming regulatory milestones, that we have throughout 2024.
Well, thanks, Kevin. With that, we can conclude the presentation.