Good afternoon, everyone, and welcome to the Wells Fargo Healthcare Conference. It's my pleasure to introduce Kevin Moran, the SVP , C F O, and Treasurer of Vanda Pharmaceuticals. Vanda has multiple commercialized products, a robust pipeline with recent and upcoming regulatory filings. We'll begin with a presentation, and with that, I'll hand things over to Kevin.
Thanks very much, Jeff, and thanks to the entire Wells team for having us here. I'm very excited to talk with you guys today about our progress and our upcoming milestones. Vanda is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. In a bit more detail about what we have going on, we have three commercialized products. We have Fanapt, which is approved in the United States for adults with schizophrenia and bipolar disorder. We have Hetlioz and Hetlioz LQ. Hetlioz is approved in the United States for both non-24-hour sleep-wake disorder, or non-24, as well as nighttime sleep disturbances in Smith-Magenis syndrome. The LQ formulation, the liquid formulation, is available for pediatric patients in the US . In addition, Hetlioz is approved in Europe for non-24-hour sleep-wake disorder and currently marketed in Germany.
In addition to those two products, we have Ponvory, which is approved in multiple sclerosis and was acquired from Johnson & Johnson at the end of 2023. In addition to those three commercialized products, we have a very robust pipeline with a number of recent and upcoming regulatory submissions. The three of which I would note at the top here are at the end of the year this year. We have tradipitant, which has an upcoming NDA, PDUFA decision on December 30th. We have Bysanti, which has a PDUFA date of February 21st of 2026 in both schizophrenia and bipolar disorder. Finally, we have imsidolumab, which we in-licensed from AnaptysBio earlier this year, where we expect to submit a BLA by the end of this year, and therefore likely will have a PDUFA date sometime in the back half of next year, assuming it's accepted for filing.
In addition to those upcoming regulatory milestones, we have a number of products at various stages of development across a wide range of therapeutic areas. From a financial perspective, we ended the second quarter with approximately $325 million of cash and no debt. Turning now to a bit more detail on our commercialized products. As I mentioned, Fanapt is approved here in the US for adults with bipolar disorder and schizophrenia. The bipolar disorder approval came in April of 2024. In the wake of that, we have significantly expanded our commercial footprint here in the United States. We ended last year with approximately 150 reps in the U.S., and we disclosed at the end of the first quarter that we were increasing that presence up to about 300 reps in the middle of this year.
We've seen very nice prescription growth as a result of these commercial efforts, most recently touching on 2,300 TRXs for a week in the middle of August. Just for some context, that compares to 1,300 - 1,400 TRXs per week around the middle of last year. Very nice and significant growth. From a new-to-brand perspective, we saw last week about 240 NBRXs for the most recently disclosed week, and that compares to about 40 NBRXs per week at this time last year. Significant growth as we continue to see success from our commercial efforts. In addition, as I mentioned, we're pursuing FDA approval for Bysanti, again for both bipolar and schizophrenia disorder. Our NDA was accepted for filing by the FDA with a PDUFA date of February 21st in 2026.
As part of that disclosure of the acceptance of the filing, we noted that the FDA had not identified any review issues at that time. In addition to that upcoming PDUFA date, we have a clinical program underway for Bysanti in major depressive disorder with results expected in 2026. Finally, on the Fanapt side, we have our long-acting injectable formulation of Fanapt that has a phase III program for schizophrenia underway. Turning now to Hetlioz. Hetlioz, approved in the U.S., for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome. We had an unfavorable court decision in the Delaware District Court at the end of 2022, which allowed generic competition in the market. We're now closing on three years with generic competition.
We've seen some erosion in our revenue over that period of time, but we actually still maintain the majority of the patient population, even now almost three years from generic competition. In addition to our commercial efforts around Hetlioz, we continue to pursue FDA approval in a number of other indications, including insomnia and jet lag. On the Ponvory front, as I mentioned, we acquired Ponvory from Johnson & Johnson at the end of 2023. The acquisition price of that product was a $100 million upfront payment with no back-end milestones and royalties. It's approved in multiple sclerosis, and we completed the transition activities from Johnson & Johnson by the end of the third quarter of 2024. At that time, we initiated our own commercial launch activity. Still a few quarters in now to the commercial launch.
Of note, during our second quarter update, we noted that the number of patient demand in the second quarter was higher than what it had been in the first quarter, which is the first quarter that we've seen that transition since we acquired the product. In addition to the commercialization of Ponvory in multiple sclerosis, we are also pursuing Ponvory in the treatments of ulcerative colitis and psoriasis. A bit more detail on our strategic focus. We're focused on increasing revenue, both organically through our existing products that I just covered in some detail there. We're also focused on potentially increasing revenue through business development opportunities. Obviously, we've had some level of activity here given the recent J& J transaction with Ponvory and the AnaptysBio in-licensing deal with imsidolumab. We continue to focus on looking for potential opportunities to increase revenue through business development.
We are focused on advancing our pipeline, again, both through the upcoming regulatory milestones that I mentioned with our three PDUFA dates likely between now and the end of next year, which could result in us increasing our commercial presence from the current three products on the market to potentially as many as six products on the market by the end of next year. In addition to that, we have a number of other clinical outcomes that are expected over the coming periods. Finally, we have a significant focus on the consumer. Wherever possible, we're looking to increase access and affordability for patients to our medications and engage directly with consumers at every opportunity. Commercial milestones and priorities. As I mentioned, we're in the midst of the commercial launch activities with Fanapt for bipolar disorder while continuing to remain focused on the existing schizophrenia market.
Hopefully, we'll be receiving a Bysanti approval sometime early next year and focused on introducing Bysanti to the market and continuing to commercialize our broader psychiatry portfolio. With the Bysanti major depressive disorder program underway and results expected by the end of 2026, if we see positive results there, we could move towards a regulatory submission soon after and hopefully have that added to the label, assuming Bysanti has been approved. On the Hetlioz front, we continue to focus on retaining market share in the face of generic competition with a focus on patient loyalty. We continue to look to grow Hetlioz in the SMS market in the U.S., where the generics do not have SMS on their label. We remain focused on pursuing approval for Hetlioz for SMS in the European market where it's currently only approved for non-24-hour sleep-wake disorder.
We remain committed to seeking approvals for Hetlioz in additional indications beyond those currently approved. On Ponvory, as I mentioned, in the back half of last year, we initiated the commercial launch activities associated with Ponvory in multiple sclerosis. We're excited about the progress that we're continuing to see there as we head through 2025. We are in the process of pursuing additional treatments for Ponvory in the form of psoriasis and ulcerative colitis. Finally, on tradipitant, with our upcoming PDUFA date at the end of this year, we're preparing for commercialization of that asset if we ultimately receive approval, likely with a commercial launch sometime in early 2026. Turning now to our research and development pipeline. As I mentioned, Fanapt, we are pursuing the long-acting injectable formulation, which is currently in phase III for schizophrenia, and we're in the process of initiating a program for hypertension as well.
On Bysanti, in addition to the upcoming regulatory milestones for both bipolar disorder and schizophrenia, we have our major depressive disorder program underway with results expected in that phase III trial by the end of next year. On Hetlioz, we continue to pursue a number of indications, and again, Hetlioz for jet lag disorder and insomnia are currently at the regulatory stage. On Ponvory, in addition to multiple sclerosis, we're in the process of phase III programs for both psoriasis and ulcerative colitis. On the tradipitant front, the gastroparesis and motion sickness programs are both at the regulatory phase with our motion sickness PDUFA date on December 30th of this year. Finally, for the recently in-licensed imsidolumab in generalized pustular psoriasis, we're moving towards our BLA submission by the end of this year, which again, hopefully will have us with a PDUFA date sometime in the back half of 2026.
Now, in a bit more depth on some of our programs. Fanapt for bipolar disorder, as I mentioned, it was approved for adults with bipolar in April of 2024, and we're underway with our commercialization efforts. Our submission of an MAA to the EMA was done in the fourth quarter of last year. On the long-acting injectable front, our phase III program for the LAI formulation for schizophrenia is underway, and it could reach the market after 2026. In the U.S., market, there are pending patent applications, which, if issued, could extend exclusivity into the 2040s. On tradipitant, on the gastroparesis side, we continue to pursue FDA approval for tradipitant in patients with gastroparesis. We had a phase III study results reported in February of 2022, which was a 12-week study of 200 patients with both idiopathic and diabetic gastroparesis.
That was on the heels of our phase II positive study, which had results reported back in December of 2018 and published in gastroenterology in January of 2021. On the motion sickness side, our NDA is under review by the FDA with the PDUFA date on December 30th, and that was supported by three positive studies. First, a positive phase III study with results reported in May of 2023. That was followed by a second positive phase III study with the results reported in May of 2024. The two of those followed the phase II study that had positive results reported in July of 2019. Turning now to tradipitant for gastroparesis. As I mentioned, we've completed two clinical studies of tradipitant in gastroparesis. Gastroparesis represents a significant unmet medical need, with the last approved treatment option approved more than 40 years ago.
In the U.S., it's estimated that there's 600,000 people that have been diagnosed with gastroparesis of a potential total population of 6 million. Of note, the only approved treatment option of metoclopramide sees approximately 300,000 prescriptions on a monthly basis, underscoring the significant potential opportunity if tradipitant were to receive approval for gastroparesis. The symptoms and clinical expression of gastroparesis, both diabetic or idiopathic gastroparesis, are characterized by chronic nausea, where patients suffer with chronic debilitating nausea and other associated symptoms. Vomiting, where gastroparesis can lead to vomiting, ultimately resulting in weight loss and even hospitalization in certain circumstances. Delayed gastric emptying and other additional GI symptoms. A bit more depth on our clinical program. The phase II study for tradipitant in gastroparesis, the 2301 study, was a four-week study of approximately 150 adult patients, again with diabetic or idiopathic gastroparesis.
In the study, tradipitant was shown to be effective in improving both nausea and the overall symptoms of patients with gastroparesis. The efficacy that was established by tradipitant in the four-week phase was persistent in the open-label phase. That was followed by our phase III study, the 3301 study, which was a 12-week study of approximately 200 adult patients, again 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 remains open, and we have over 300 patients that have been enrolled in that phase of the study. Finally, on the expanded access program, we've initiated an expanded access program for patients who've requested access to tradipitant outside of the clinical studies.
We continue to this day to receive requests from patients who have reached out to gain access to tradipitant through the expanded access program, which has multiple patients now that have continued to take tradipitant for beyond a year. On the pooled study results of gastroparesis, this is the pooled study results of the phase II and the phase III study. We completed a pooled analysis of these two clinical studies. The population of the pooled analysis was 342 patients with relevant clinical endpoints. Of note, both studies were large, multi-site, randomized, double-blind, placebo-controlled studies. In the pooled analysis, tradipitant was shown to be superior to placebo in key clinical parameters, including the primary endpoint of daily diary nausea. Of note, both studies demonstrated the efficacy of tradipitant in relieving the symptoms of gastroparesis. Turning now to motion sickness. The core symptoms of motion sickness are nausea and vomiting.
This is the result of a sensory mismatch due to discordance between the actual and expected movement as perceived by various bodily symptoms. In the U.S., Dramamine, which is the most commonly used treatment, sees approximately 2 to 3 million doses in an individual month, underscoring again what a significant potential opportunity tradipitant for motion sickness could be. A bit more detail on the programs. As I mentioned, we had two phase III studies completed, both of which were positive. The first phase III study had 365 patients randomized into either 85 mg or 170 mg arms. Both the 85 mg and 170 mg arms met the primary endpoint of preventing vomiting on boats. The second phase III study had 316 randomized, and again, the two arms, the 170 mg and the 85 mg arm, both met the primary endpoint of preventing vomiting as well.
As I mentioned, with the study results now completed, the NDA submitted and accepted, we're awaiting the FDA decision at the end of this year on our PDUFA date. Turning now to our early-stage programs. In addition to some of the programs we covered on the earlier slides, we have our CFTR programs, which include both VSJ110, a CFTR activator, which has been shown to have efficacy in a dry eye model and exhibited anti-inflammatory properties. We have VPO-227, which is a CFTR inhibitor, which has potential utility in a number of different indications, including cholera. Of note, on the cholera side, VPO-227 was granted orphan designation by the FDA for the treatment of cholera.
In addition to our early-stage programs on CFTRs, we have our VTR297 program, an HDAC inhibitor, where we're pursuing that in hematologic malignancies, as well as VQW-765, where we're pursuing a phase III program for social performance anxiety. Finally, turning to our financial results. In 2025, our financial guidance is total revenues of $210 million to $250 million, midpoint of $230 million. Year-end cash of 2025 of $280 million- $320 million, midpoint of $300 million. Of note, in the second quarter of 2025, our revenue was $52.6 million, which included Fanapt net product sales of $29.3 million, Hetlioz net product sales of $16.2 million, and Ponvory net product sales of $7.1 million. For the results for the full year, or sorry, the full year, the six months ended June 30th, 2025, our revenue was approximately $103 million, with Fanapt being the lead revenue generator at approximately $53 million.
We had operating expenses of approximately $182 million for a net loss of approximately $57 million. As I mentioned, we ended the second quarter with $325 million in cash and no debt. Thanks very much for everybody's interest, and we're excited to continue to share updates with you in the future as we have additional progress.