Good afternoon. Thank you very much for being here with us today. My name's Raji Gunasekera. I'm an associate on the healthcare team at JPMorgan. Today I'm pleased to introduce Vanda Pharmaceuticals, and we have their CFO, Kevin Moran. Thank you.
Thanks, Raji, thanks to the entire JPMorgan team for having us today. Very excited to talk to you about the progress of our company, Vanda Pharmaceuticals, as well as our upcoming milestones. Turning now to our forward-looking statements. Folks should be aware of these as we review the slides in the presentation today. Beginning with our commercialized products. Vanda has two products on the market, HETLIOZ and Fanapt. HETLIOZ capsules are approved in the U.S. for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in patients with Smith-Magenis Syndrome in adults. Additionally, the capsules are approved in Europe for Non-24-Hour Sleep-Wake Disorder. In addition to HETLIOZ capsules, the HETLIOZ LQ liquid formulation is approved in the United States for pediatric patients with nighttime sleep disturbances in Smith-Magenis Syndrome.
In addition to HETLIOZ, Fanapt is approved in the United States for the treatment of schizophrenia in adult patients. Turning now to our clinical development pipeline. We'll step through these in greater detail as we work through the presentation, beginning with HETLIOZ. In addition to the commercial indications I previously mentioned, HETLIOZ is in development for a number of lifecycle management activities, including jet lag disorder, insomnia, delayed sleep phase disorder, or DSPD, autism spectrum disorder, or ASD, and NON24 in the pediatric patient population. Fanapt, in addition to schizophrenia, is in development for bipolar I disorder, the long-acting injectable formulation of Fanapt, and Parkinson's disease psychosis. Tradipitant is in development for gastroparesis, motion sickness, and we've previously provided updates on our atopic dermatitis and COVID-19 pneumonia programs. In addition to those assets, we have a number of other assets in various stages of clinical development.
Turning to our financial objectives and highlights. Our previously communicated 2022 financial objectives and guidance include total revenues of $240 million-$270 million, which consist of HETLIOZ net product sales of $150 million-$170 million, Fanapt net product sales of $90 million-$100 million. In addition to that revenue guidance, we've also provided year-end 2022 cash guidance of ending the year with greater than $450 million in cash. For our previously reported Q3 2022 financial highlights, our revenues for the period were $65.3 million, which included both HETLIOZ and Fanapt revenues. Our HETLIOZ revenue for the period was $41.3 million, and our Fanapt revenue for the period was $24 million. Turning now to our top priorities and milestones, beginning with our SMS program.
Our HETLIOZ for nighttime sleep disturbances in Smith-Magenis syndrome was approved at the end of 2020 and was made immediately available in the capsule formulation for adults at that time with the liquid LQ formulation following in early 2021. We continue to pursue our commercial launch there with the total estimated US patient population of approximately 15,000 patients. Next, we have our Tradipitant for gastroparesis program, where we announced our phase III study results in early 2022, and recently announced that we'll be pursuing an NDA filing in the first half of 2023. On HETLIOZ for delayed sleep phase disorder, this is a late-stage program which we believe has a high probability of technical success, and the estimated US patient population is approximately 1% of the US population, so obviously representing a significant market opportunity.
Finally, our Fanapt programs, where we have our bipolar I disorder with our recently announced positive phase III study results at the end of December 2022, as well as our continued development of the long-acting injectable formulation of Fanapt. Beginning with our efforts on HETLIOZ for Smith-Magenis syndrome. As noted, this was approved in December 2022. December 2020, apologies. Its estimated patient population for sleep disturbances in Smith-Magenis syndrome is approximately 15,000 individuals. SMS is characterized by major physical, developmental, and behavioral disorders, the most prominent of which is severe sleep disorder. Upon receiving FDA approval, we immediately launched in the capsule formulation at the end of 2020 and the liquid formulation at the beginning of 2021.
We began converting the patients that had participated in our clinical study, as well as those that had expressed interest onto commercial treatment. In collaboration with the primary advocacy group in the space, PRISMS, we began contacting families and individuals with SMS to make them aware of the condition and the potential treatment option. Since then, we've continued to work with diagnostic centers and tertiary care clinics, where patients are expected to first come seeking treatment once they've received a diagnosis of Smith-Magenis syndrome. We've began a targeted, direct-to-consumer campaign for families and the individuals affected with SMS, again, to make them aware of both the condition, where there's a low level of awareness in the patient community, as well as the potential therapeutic option. Again, turning now to our research and development efforts.
Here's our clinical development pipeline slide, which we previously stepped through, we'll step through these individual indications as we work through the presentation. Beginning with Tradipitant. As mentioned, we're pursuing Tradipitant for a number of indications, first of which is gastroparesis. Our phase three study results, again, were reported in February of 2022. That phase three study was a 12-week study of approximately 200 patients with idiopathic or diabetic gastroparesis. Our previously reported phase two study, where we reported positive results in December of 2018 and published those results in Gastroenterology in January of 2021. In addition to those two studies, we've have an expanded access program where we're making Tradipitant available to patients who would like to seek treatment with it who didn't participate in those studies.
We expect to submit an NDA for Tradipitant in the treatment of short-term nausea and gastroparesis in the first half of this year. Turning now to motion sickness. Our phase 3 study is currently enrolling patients, and we expect results by mid-2023. That phase 3 study comes on the heels of our phase 2 positive study, where we reported results in July of 2019. In addition to gastroparesis and motion sickness, we've previously updated on atopic dermatitis and our COVID-19 pneumonia programs. Now in a bit more detail on Tradipitant for gastroparesis. As noted, we've completed 2 clinical studies and are preparing for our submission of an NDA in the first half of this year. Gastroparesis is a significant unmet medical need with the most recently approved treatment option approved more than 40 years ago.
In the U.S., there's estimated to be 6 million people impacted with gastroparesis. Of those, approximately 600,000 have been diagnosed. For the only approved treatment option for gastroparesis, metoclopramide, there's approximately 300,000 prescriptions on a monthly basis. Tradipitant for gastroparesis obviously represents a significant market opportunity given the patient prevalence as well as the limited treatment options available. On the symptoms and clinical expression of gastroparesis, for diabetic or idiopathic gastroparesis, it's 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, where many patients have a mechanical defect that delays their gastric emptying and may be the cause of many of their symptoms. Additional GI symptoms, including fullness and abdominal pain.
On our clinical program, our Phase II study or the 2301 study, was a 4-week study of approximately 150 patients, adult patients with diabetic or idiopathic gastroparesis. Tradipitant was shown to be effective in improving nausea and the overall symptoms in patients with gastroparesis, and the efficacy established during the 4-week portion was persistent in the open label phase as well. Our Phase III study, the 3301 study, was a 12-week study of approximately 200 patients, also 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. As previously mentioned, the open label phase remains open with approximately 300 patients already enrolled.
Our expanded access program is available for patients requesting access to Tradipitant outside of our clinical studies. We continue to receive requests from patients hoping to gain access, where we now have multiple patients who've taken Tradipitant for more than a year. Our phase II study, which we've largely covered this in our previous slides, results in December of 2018 with them published in Gastroenterology in January 2021. A 4-week study, with approximately 150 patients with a number of assessments, as you can see on the right side of the slide. Also our phase III study, again, a 12-week study with approximately 200 randomized patients with the same assessments. Our pooled study results from the 2 gastroparesis clinical programs. We've completed a pooled analysis of our 2 clinical studies of Tradipitant for gastroparesis.
The population includes 342 patients where we measured relevant clinical endpoints. Both of these studies were large, multi-site, randomized, double-blind, placebo-controlled studies. In the pooled analysis, Tradipitant was shown to be superior to placebo in a number of key clinical parameters, including the daily diary nausea, which is our primary endpoint, % nausea-free days, and our patient global impression scale change, as well as our overall benefit score and gastroparesis cardinal symptom index score. The conclusion, both studies demonstrate the efficacy of Tradipitant in relieving symptoms of gastroparesis. The next slide is a visual depiction of the pooled study results, which I'll step over. Turning now to our motion sickness program. Again, Tradipitant is currently in development for motion sickness in phase 3, with our results expected mid-2023. The core symptoms of motion sickness are nausea and vomiting.
The sensory mismatch that results in motion sickness is due to discordance between actual and expected movement as perceived by various bodily symptoms. As far as market opportunity goes, as a relevant data point, there's approximately 2-3 million doses of Dramamine purchased in the U.S. each month. Our Phase II study results were reported again in July of 2019, published in Frontiers in Neurology in September of 2020. The conclusion was Tradipitant was shown to be effective in preventing motion sickness. An exploratory analysis was performed, where the effects of Tradipitant were measured under both calm and rough seas. Under the rough sea conditions, which is seas above 1 meter, approximately 72% of the placebo-treated patients vomited, compared to approximately 16% of those treated with Tradipitant.
A significant effect was also observed under rough sea conditions in the MSSS worst score, or Motion Sickness Severity Scale worst score. Turning now to our HETLIOZ lifecycle management activities. Again, in addition to the previously approved indications of NON24 and nighttime sleep disturbances in Smith-Magenis syndrome, we continue to pursue HETLIOZ in delayed sleep phase disorder, where a Phase 3 program has been initiated. Autism spectrum disorder, where our Phase 2 open label study currently being conducted will be followed by a Phase 3 randomized placebo-controlled study, as well as continuing to pursue the NON24 indication in the pediatric patient population, as well as jet lag disorder. On delayed sleep phase disorder, it's estimated to impact over 3 million adults in the U.S. The prevalence is highest in adolescents, and young adults, with rates of between 3 and 5%.
The prevalence in adults is lower, with estimates between 0.2% and 1.7%. In a study of patients with circadian rhythm sleep disorders, DSPD was shown to be likely the most common sleep disorder, with approximately 83% of those folks diagnosed with DSPD. Of those folks diagnosed with DSPD, approximately 90% of the patients report onset of their symptoms during childhood or as adolescence. The symptoms and clinical expression of DSPD. DSPD is characterized by delayed sleep onset, where individuals habitually go to bed and wake up significantly later than typical or desired times. Sleep insufficiency and daytime impairment, where the delayed bedtime, combined with conventional school work start times, causes significant reductions in total sleep time for these patients. Clinical history, where DSPD typically emerges during adolescence. Finally, comorbidities, where comorbid depression is common amongst patients with DSPD.
Turning now to our Fanapt life cycle management activities. Again, our bipolar I disorder program is complete. Our positive results were announced in December of 2022. We expect to submit an sNDA for Fanapt in bipolar disorder in 2023. Additionally, our Parkinson's disease psychosis program continues to progress with two studies planned, a phase II open label study of two cohorts, followed by a larger randomized placebo-controlled phase III study. Additionally, our long-acting injectable formulation of Fanapt continues in development. Currently, a PK study is underway, where we're finalizing and optimizing dosing and administration. A phase III study of the long-acting injectable formulation for acute schizophrenia treatment will follow . Finally, our VHX-896 or formerly known as P-88 compound.
Currently a bioequivalent study is underway, and as a reminder, VHX-896 is the active metabolite of iloperidone or Fanapt that we believe has the potential to improve the clinical profile of Fanapt and create sustained long-term value in the psychiatric space. On our bipolar I disorder study results. Results were reported in December of 2022. Our phase III program enrolled approximately 400 volunteers who had a history of bipolar I disorder and were currently suffering from an episode of mania. The primary endpoint assessed was the YMRS scale, or the Young Mania Rating Scale, which is a rating scale of clinical severity in the core symptoms of mania. Reviewing the YMRS change from baseline at week four, Fanapt was significantly superior to placebo.
In addition to that, the secondary endpoints, clinical global impression of severity and clinical global impression of change, also achieved statistical significance in the study. Of note, bipolar disorder is highly prevalent in the U.S., with estimates of approximately 3% of the U.S. adult population suffering. Vanda plans to submit this pivotal study data of Fanapt for the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults in a sNDA or supplemental new drug application in 2023. Turning now to our early stage programs. Our cystic fibrosis transmembrane conductance regulators or CFTR programs include VSJ-110, which is a CFTR activator that has shown efficacy in a dry eye model and exhibited anti-inflammatory properties in both in vitro and in vivo assays.
We have an ongoing phase II conjunctivitis study investigating the anti-inflammatory effect of VSJ-110 following the ragweed ocular challenge. We have VPO-227, which is a CFTR inhibitor, and that compound is in development for cholera disease, where it was recently granted orphan drug designation by the FDA for the treatment of cholera. We have our VTR-297 compound, which is an HDAC inhibitor, currently in an ongoing phase II study in hematologic malignancies at sites in the US and Europe. We have our VQW-765 compound, which recently had phase II study results reported in a single dose treatment to alleviate social performance anxiety. Again, those results were announced in December of 2022. We have our ASO program.
In September of 2022, Vanda announced a research and development agreement with OliPass to jointly develop a set of ASO molecules based on OliPass' proprietary modified peptide nucleic acids. This evolving discovery and development program is intended to support Vanda's development of ASO-based precision medicine therapeutics. We've already identified two ASO targets that have been validated in cell lines that model two disease targets, one a rare orphan target, and the other applicable to a broad set of conditions. Turning back to our financial results. Again, our 2022 financial objectives and guidance.
Our total revenue guidance for the year was $240 million-$270 million and consisted of HETLIOZ net product sales of $150 million-$170 million, Fanapt net product sales of $90 million-$100 million, and year-ending cash of greater than $450 million. Our financial results through September 30, 2022 included approximately $120 million of HETLIOZ net product sales, $70 million of Fanapt net product sales, for a total revenue through nine months of approximately $190 million, and Q3 ending cash of approximately $455 million. That concludes our presentation. I'd like to thank everybody for their time and look forward to providing you with updates on our upcoming milestones.
Thank you very much. The company will not be taking questions today. We appreciate your attendance. Thank you.
Thank you, sir. Good one