Vanda Pharmaceuticals Inc. (VNDA)
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Cantor Global Healthcare Conference 2025

Sep 3, 2025

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

All right. Hey, good afternoon, everyone. Thank you for joining us at our first day of our Cantor 2025 Healthcare Conference. My name is Olivia Brayer. I'm one of the senior biotech analysts here at Cantor, and really excited to have with us Kevin Moran today, who is CFO at Vanda Pharmaceuticals. Kevin, thanks for joining us.

Kevin Moran
CFO, Vanda Pharmaceuticals

Yeah, thanks so much, Olivia.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Yeah, and I know, Kevin, you're going to go through some slides, and then we'll get into Q&A afterwards.

Kevin Moran
CFO, Vanda Pharmaceuticals

Perfect. Thanks again, Olivia, and thanks to the Cantor team for having us here today, and thanks for all of you joining us in the audience. So first, I'll just give you kind of a brief overview of the company, and then obviously we'll have some Q&A here, where I'm sure Olivia will have some great questions to ask me. So just to give you guys a quick background, Vanda is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercial products. So we have Fanapt, which is approved in the U.S. for schizophrenia and bipolar disorder, and is an atypical antipsychotic. We have Hetlioz and Hetlioz LQ. Hetlioz and Hetlioz LQ are approved in the U.S. for non-24-hour sleep-wake disorder, and the liquid formulation is also approved for nighttime sleep disturbances and Smith-Magenis syndrome in the pediatric patient population.

And then Ponvory is approved in the U.S. for multiple sclerosis. In addition to those three commercial products, we have a very robust pipeline with a number of recent and upcoming regulatory submissions, including three upcoming PDUFA dates. Later this year, we have the tradipitant NDA in motion sickness with a PDUFA date of December 30th. Early next year, we have the milsaperidone PDUFA date in both bipolar disorder and schizophrenia. That's in February of 2026. And then finally, with imsidolimab, which we recently in-licensed from Cycle Pharmaceuticals, we expect to submit a BLA later this year, which will likely give us a PDUFA date sometime in the back half of 2026. And that's in Generalized Pustular Psoriasis (GPP). In addition to that, we have a wide range of products in development across a wide range of therapeutic areas at various stages.

And then supporting those commercial products and that clinical development pipeline, we're in a very strong financial position. We ended the second quarter with about $325 million in cash and no debt. Our revenue guidance for the year is $210-$250 million, so midpoint of $230 million. Our cash guidance for the year is to end the year with between $280 and $320 million, so a midpoint of $300 million. Turning now to our commercialized products. As I mentioned, Fanapt is approved in the U.S. for both the acute treatment of bipolar disorder as well as the treatment of schizophrenia. We're currently pursuing the approval of milsaperidone for both of those indications with our NDA accepted earlier this year. A little commentary on our NDA process there.

We disclosed late last year that we had a positive pre-NDA meeting with the agency and felt comfortable with the submission package that we planned to submit. Earlier this year, we provided an update where we noted that the FDA had accepted our filing for submission and given us the PDUFA date in February of 2026. As part of that, we noted that there were no review issues identified at that time, which we felt noteworthy given that in general, we've seen review issues on our other applications, both those that were approved and those that were not approved. So the fact that there were no review issues identified at that time, we felt very optimistic about that. And then we presented our bioequivalence data at ASCP in May of 2025, and we felt very confident that that data showed compelling and convincing bioequivalence between milsaperidone and iloperidone.

We continue to progress towards that PDUFA date in early next year. In addition to that, we're running a phase III program for milsaperidone in major depressive disorder. We've guided to results expected on that in 2026, which hopefully means with positive results, we could have that on a milsaperidone label sometime in 2027 or 2028. In addition to that, we are developing the Fanapt long-acting injectable formulation. Currently, that's in phase III for schizophrenia. We have not yet provided guidance on the clinical trial results there other than we think that could potentially be on the market sometime after 2027. Turning now to Hetlioz . As I mentioned, that's approved in the U.S. for both non-24-hour sleep-wake disorder as well as nighttime sleep disturbances and Smith-Magenis syndrome, both of those orphan indications.

In late 2022, we had an unfavorable court ruling in the Delaware District Court whereby generics were allowed to enter the market. So we've now had generic competition on the Hetlioz side for coming up on three years. However, we've seen very strong resiliency in the brand itself, where we maintain the majority of the market share and continue to see patients' loyalty driving the underlying business there. In addition to that, we have Hetlioz approved in the European market and currently marketed in Germany. And we're pursuing FDA approval for a number of different indications, including insomnia and jet lag disorder, where there's been some recent developments that I'm sure we'll maybe get into during the Q&A session. And then finally on Ponvory.

Ponvory is a drug approved for multiple sclerosis that we acquired from Johnson & Johnson at the end of 2023 for a $100 million upfront with no back-end milestones or royalties. There was a transition period whereby we began our commercial activities in the back half of last year. And we commented as part of our second quarter earnings call that we saw for the first time since we acquired the product, increased patient demand in the second quarter relative to the first quarter. So feel very encouraged that we're beginning to see the turning of the tide there back to Ponvory growing in future periods. And in addition to it being approved in multiple sclerosis, we plan to pursue it for other indications at a minimum, ulcerative colitis and psoriasis.

Now turning a bit to the strategic focus of the company, obviously we're focused on increasing revenue both organically from our existing products, those three that are on the market and the three that have upcoming PDUFA dates, where we potentially could have as many as six products on the market by the end of 2026. We're also focused on exploring business development opportunities. Obviously, we've been active in the space with the Ponvory acquisition at the end of 2023, as well as the in-licensing of imsidolimab from Cycle Pharmaceuticals earlier this year.

And we continue to explore other opportunities where we could be active in the space. Most notably, we've built out a significant commercial presence in both the psychiatry space and the neurology space. And it would be interesting if there were opportunities to leverage those footprints for other products that could be synergistic with our existing revenue streams.

We can remain focused on advancing our pipeline both through the form of our upcoming regulatory milestones, but as well as the other assets that we have in development, which are, again, various stages, and we expect to be kind of milestones for the upcoming years to come. And then we continue to have a consumer focus. We very much remain focused on increasing access and affordability for patients to our medications. We believe that folks that need access to them should have access to them. And wherever possible, we look to engage directly with consumers. Priorities and milestones for the year. So as I mentioned, our revenue guidance for the year, $210-$250, $230 midpoint. We haven't provided product-specific guidance, but maybe just a bit of color to kind of orient us on where we see things.

Beginning with Hetlioz, as I mentioned, Hetlioz had a generic enter the market in late 2022. We've seen erosion of the revenue over the course of the last few years, but we maintain the majority of the market share and have been very pleased with the resiliency there. And that remains our focus, right, is to, while we continue to pursue restoring exclusivity of Hetlioz in the market space, we remain focused on the resilient product brand and maintaining what revenue we absolutely can as we move forward there. On Ponvory, as I mentioned, we remain focused on transitioning the product in-house, relaunching commercial activities, and restoring the product to growth. And on tradipitant, we are focused on preparing for the potential commercial launch of tradipitant sometime early next year if we're able to receive approval from the FDA around the end of this year for motion sickness.

And we continue to pursue gastroparesis with the FDA, where we received a CRL late last year and remain engaged on steps forward. And then finally on Fanapt and kind of segueing that into milsaperidone, we're very focused on expanding our footprint this year on Fanapt and all the commercial efforts supporting the brand. We've seen great success on the hiring front, interactions with prescribers, driving up call volume, and that translating into prescription growth and revenue growth, as we could see in the second quarter and we expect to see in future periods. And that all lays the groundwork for the upcoming, hopefully, milsaperidone launch with an approval sometime early next year. So I feel like we're establishing a very good psychiatry foundation that'll both support Fanapt revenue growth for the upcoming years, but even much more so milsaperidone revenue growth in the years to come.

And then just quickly here on our pipeline. So beyond the programs that I just mentioned, a few of which are listed here, I'll just highlight a couple of other areas where we are developing our assets. So Fanapt, in addition to the oral tablets, we have a long-acting injectable formulation, which is currently in phase III for schizophrenia. And we're actively pursuing additionally hypertension in the space, where we will have updates in future periods on the program there. On milsaperidone, as I mentioned, we've got the upcoming regulatory update on bipolar and schizophrenia and the major depressive disorder program with results expected in 2026.

On Hetlioz , we have a number of indications that we're pursuing, some of which are at the regulatory phase, some of which are still in phase III that we are very excited about continuing to pursue as we hopefully navigate a path there with the FDA. On the Ponvory side, again, in addition to multiple sclerosis, we have phase III programs for psoriasis and ulcerative colitis. On tradipitant, we're also at the regulatory stage with gastroparesis and motion sickness with our upcoming PDUFA date at the end of this year. And then finally, with imsidolimab, again, we've got our GPP indication where we expect to submit a BLA by the end of the year and have a PDUFA date sometime in the back half of next year. And then maybe just finally before doing our Q&A, just a quick financial summary just to ground ourselves here.

So again, as I mentioned, for 2025, our financial guidance is revenues of $210-$250, a midpoint there of $230. Our year-end cash, we expect to end between $280 and $320, so a midpoint of $300. We ended last year with a little more than $375 million, so the midpoint there would suggest a $75 million cash burn for the year. And we ended the second quarter with about $325 million, which $50 million burn for the first half of the year also included the $15 million payment made to Cycle Pharmaceuticals as part of the in-licensing of Imsudolimab. Our Q2 revenue was about $53 million for the quarter, which included significant revenue growth from Fanapt both sequentially and year-over-year basis. And that rose Fanapt revenue to $29.3 million.

We continue to see resilient production from Hetlioz in the face of generic competition and Ponvory stabilizing. And as I mentioned, us beginning to see hopefully increased patient demand in future periods. That I think we'll do Q&A.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Yeah, great. Thank you very much, Kevin. Very, very helpful overview. So I mean, maybe we'll start with the broader financial picture first, just since we ended on that slide. I look at your company and I see you have a strong cash position. You have revenues that are growing. You have a 230+ revenue base, but your market cap obviously tells a very different story. So I mean, what do you think the disconnect is? Is the strategic focus for you all, is it really around new growth drivers? Is it around extending IP or extending revenue run rate? What do you think gets investors or maybe that investors are missing about this story that you think you guys can prove out over the next six to 12 months?

Kevin Moran
CFO, Vanda Pharmaceuticals

Yeah. For me, we obviously have a lot of different things going on, both from a commercial perspective, a regulatory perspective, and a clinical perspective. I think that although we love all of our products and think they all have the potential to add tremendous value, for me, the most obvious disconnect and the most, the easiest place to create awareness that I think would translate into value creation is the Fanapt and milsaperidone story, right? So Fanapt, for just a little bit of a reminder here, has been on the market since 2009, originally approved in schizophrenia, approved in 2024 for bipolar disorder, so nearly 15 years after the initial approval.

And at the time, we had seen the Fanapt revenue base eroding very slowly. So we'd seen small unit decline and the revenue essentially flat. Since we received approval for bipolar, we've significantly increased our presence out in the field. And that in the early periods, we saw that translate into productivity in the form of hiring, target interaction, call volume, and general engagement in the space, and some translation into script growth in the back half of last year, albeit relatively small. As we exited last year and entered this year, that was really where most of the field had been in place for a period of time where they could begin to have some regular engagement with prescribers, see them with some frequency.

What we saw as we were exiting the first quarter and on our Q1 earnings call, we're talking about it, is we saw an acceleration there of prescription demand. So we saw five-year highs in TRXs. We saw MBRXs spike to TRXs being total prescriptions, MBRXs being new-to-brand prescriptions. The new-to-brand prescriptions were all-time highs from the data that we had. And so that was obviously very exciting to begin to see that translate and gave us additional conviction about the potential of both Fanapt and the broader psychiatry portfolio, such that we doubled down on the Fanapt sales force and went from increasing to 150 or so at the end of last year to where we reached about 300 in the last few weeks.

And so, where we saw that activity translate into prescription growth and revenue growth in the second quarter, and I would expect that to continue with our base of 150, the additional 150 taking us to 300. I would expect that to contribute to revenue later in the year as we head into next year and hopefully lead to a continuation of the productivity and the growth that we've seen, but maybe even potentially an acceleration given their additional reach and frequency.

So that, if we are able to grow Fanapt revenue, which we are showing good early indications that we're able to accomplish, and then we have a milsaperidone approval early next year and then introduce that to the market sometime next year, that sets the foundation for kind of the years to come, given that Fanapt exclusivity likely runs through the end of 2027, milsaperidone being a 505(b)(1) would be entitled to, at a minimum, the five-year exclusivity with the patents that we have going out potentially into the 2040s. And then as we go to 2027 and we're able to continue to grow what now would likely be the milsaperidone franchise, there's a few other kind of levers that I think create tremendous value there.

One is the MDD data that we expect to get in 2026 and the potential of adding that to the label in 2027 or 2028. Also, a little more complicated is some of the gross-to-net dynamics that Olivia and I have talked about on Fanapt relative to Bysanti, whereby on Fanapt, our gross-to-net is about 50%. So if last year our revenue was $95 million, it would have been about $190 million gross revenue for $95 million of net revenue. In that revenue stream, about 40% of our revenue is Medicaid, and our net revenue on that 40% of our business is essentially zero, and that's because Fanapt has been on the market for 14, 15 years, and price increases above inflation make it such that your unit rebate amount will essentially be equal to WAC. With Bysanti being an NDA, we would get a reset on that pricing.

And so there would be a 23.1% statutory discount, but that would be it. And so you could see your gross-to-net go from 50% on Fanapt to something more like 30%-35% on milsaperidone. And so using last year as the example, where $190 million translated to $95 million of revenue, that might translate to more like $140-$150 million of revenue for the same exact volume. So that's a significant kind of untapped revenue potential. And so for me, that's the biggest disconnect I see between where we're trading and where I think we should be valued is if you just add the runway of milsaperidone onto Fanapt and the potential for all of these kind of good things that I outlined, I think there's tremendous value there.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Yeah. And maybe we'll stick with Fanapt first, and then I'll ask you some follow-ups on milsaperidone. But in terms of the commercial rollout there, I mean, are the added TRX, is it entirely bipolar? Are you seeing more adoption in schizophrenia as well as you roll out bipolar? And then are there certain patient groups within those indications that maybe you're seeing better initial adoption in?

Kevin Moran
CFO, Vanda Pharmaceuticals

Yeah. So taking the first question first, so as I mentioned, what we had seen on kind of the run into the bipolar approval is that the schizophrenia, which was the only thing that the product was approved for, business was declining very slightly, like in the neighborhood of 3%-5% annually. And as the bipolar indication has rolled on, we went from calling on a group of essentially exclusively doctors that saw schizophrenia patients to a much broader group of prescribers that see both schizophrenia and bipolar patients.

And so most of the doctors that we were calling on in this expanded field force were folks that we either had never called on before or hadn't called on since the Fanapt sales force was much larger. And so while we don't have precise data as to the product indication that is underlying the TRXs, what I believe is happening is that the additional TRXs that we're seeing above kind of that declining base are almost all, if not all, attributable to bipolar, both because the schizophrenia base was declining and because of the targets that we're calling on are likely seeing bipolar patients and therefore generating the new prescription growth. So again, that's another encouraging factor for as we've seen this and the potential for continued growth, that represents kind of that untapped kind of base that we can get to. So very excited about that.

And then as far as groups that we're seeing more receptivity to, again, from a targeting perspective, where we primarily were calling on community mental health centers before with schizophrenia, now we're much more calling on a much broader set of prescribers. And again, we're seeing new prescriptions kind of across the universe, but certainly with a significant contribution from the non-community mental health center prescribers. And then as far as patient profiles, maybe in terms of where folks are using the medication, we tend to see folks that maybe have a more agitated patient profile where some of the activity of Fanapt can help to deal with that as being at least just a common, I would say, introductory point for prescribers using the medication where they haven't used it before.

And so we often find that to be kind of a good entry point is for that patient profile that Fanapt might have a better treatment profile on relative to some of the other available medications, maybe try that on Fanapt with one of your patients on that. And then when they see success there, it potentially makes them more likely to use it for more of those types of patient profiles, but maybe more just general patient profiles rather than that kind of specific niche. Sure. What about any feedback or kind of real-world feedback from payer adoption? Has that been a hurdle? Are there headwinds that you're seeing there or maybe even some tailwinds to the launch? Yeah. So a couple of things on that.

And again, Fanapt's dynamic as it continues to progress through the indication landscape and milsaperidone as well as with MDD is on Fanapt. Historically, when it was approved only in schizophrenia, what you saw was the majority of your patients were Medicare or Medicaid, with a much smaller piece being commercial. Commercial tended to be in the 10%-20% range when it was schizophrenia only. As you move into the bipolar patient population, you're going to see some more commercial patients come into that. And then eventually, hopefully, if we are able to pursue the MDD indication, even that much more so. And so given that still the significant majority of our patients are in the governmental space and the atypical antipsychotic class is a protected class, there's only so many limitations that can be put in place.

And doctors are very familiar with what those limitations are and how to navigate them, I would say, if they really want their patient on a certain medication. So the commercial segment where you're likely to see more of those hurdles still remains a relatively small portion of the patient population for Fanapt today, but certainly something that we're focused on ensuring that patients that have commercial coverage have access to Medicaid. But just given the nature of Fanapt and again, where it is on kind of the spectrum yet of patient profile, we aren't seeing that as any sort of significant hurdle at the moment, but something certainly to keep an eye towards to make sure it doesn't become one in the future. Question? Yeah. On the Fanapt, what's the value play versus Caplyta, which is obviously taking the market by storm and it's indicated in bipolar?

JJ gets $15 million for them. You're sitting there with a $300 million market cap. This is the growth story. What are your sales force telling docs? There's no discussion about Caplyta. Why Fanapt is Caplyta? Yeah. Certainly, when we're engaging with prescribers, we can only speak to our own product and our own label, right? There's going to be that dynamic. But I think what you see within the class is that it's a very high-switch class, right? This goes to Cobenfy joining the class as well. Doctors need treatment options for these patients because, unfortunately, there's no silver bullet within the class. And there's certainly pros about certain drugs from an efficacy perspective or from a safety perspective. They all kind of have their own gives and takes.

And so we see it as being another useful tool for prescribers in the same way that Caplyta and other drugs are in this complicated kind of treatment paradigm.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Okay. Great. Sure. And then maybe as we think about a potential transition to milsaperidone, I mean, maybe we'll just start out with what's been the receptivity to that bioequivalence data that you all presented a couple of months ago?

Kevin Moran
CFO, Vanda Pharmaceuticals

Yeah. Incredibly well received. And when we look at the data, and this was the poster that we presented at ASCP and is published on our corporate website, it's very clear and I think absolutely evident that milsaperidone interconverts into iloperidone and is bioequivalent at all therapeutic dosage levels. So again, this kind of fits into our broader story of that we think the bioequivalence data is very compelling. And we feel like our submission package with the bioequivalence data plus the Fanapt efficacy and safety data, we're obviously optimistic is sufficient for purposes of the FDA review.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Yeah. And you do have that PDUFA coming up in February, I believe. Correct. Anything you can tell us about the review process itself? I know you probably don't comment on active conversations with FDA. But do you feel confident that February is the right timeframe? Has there been any indication that they want to see any maybe additional data, whether it's whatever it may be, right, and whatever it may look like? Could there be a potential extension? I mean, we've seen a lot of PDUFA extensions in the last few months. Just any thoughts on the latest regulatory interactions?

Kevin Moran
CFO, Vanda Pharmaceuticals

Yeah. Maybe just a quick table set there of what we've kind of said to date, and then I'll say what I can about where we are. Again, last year when we and the milsaperidone story is a relatively recent story in terms of our public communications. Part of that's for what I'm as we both had this bioequivalence data and had interactions where we felt like we knew the path forward and then felt comfortable, obviously, then communicating it. Late last year, when we had our pre-NDA meeting, it felt like our submission package was going to be sufficient for filing. We commented on that either in our Q3 call or Q4 call last year. We submitted our filing. Again, it was accepted for review.

We noted that there were no review issues identified at that time, which, again, for us is, I would say, atypical. Generally, during filings, we see review issues, again, for the drugs that are later approved and for drugs that are not approved. As an example on that for Fanapt and bipolar, very recently, we ran one phase III study, and that was noted as a review issue as part of our filing that we were ultimately able to navigate. But the fact that there were no review issues identified was obviously better than the alternative, right, that we were happy to not have any identified and gave us a PDUFA date of February 21st. Again, the bioequivalence data that we presented, again, we felt at least more publicly made aware kind of the package that went in there.

And then the review just continues to progress as I would have expected at this point in terms of the various kind of checkmarks along the way. And the only other thing I would say there is the submission package itself, outside of the bioequivalence data, includes Fanapt data that the FDA has previously reviewed, some of it very recently given the approval just last year. And so again, hopeful that timelines shouldn't be an issue given this isn't an immense package of new data. A lot of it is data that's previously been reviewed.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Sure. Okay. Okay. That's helpful. And then commercially, as you think about a potential rollout next year, I mean, you mentioned earlier the importance, right, of getting or transitioning maybe Fanapt patients, whether it's new to brand or whether it's patients that are already on Fanapt over to milsaperidone, just given the IP, right, revenue run rate there. What is the plan? I mean, what is the hook to get patients to actually switch from Fanapt to milsaperidone? Or why would patients pick milsaperidone over Fanapt when thinking about or why would prescribers, right, prescribe one over the other as you think about potential commercial adoption there?

Kevin Moran
CFO, Vanda Pharmaceuticals

Yep. So a few thoughts there. In the future, not next year, the milsaperidone MDD trial is being run as a once-a-day trial, whereas Fanapt is twice a day. So that would be a obviously significant difference at some point in time in the future.

For next year, as we're looking at it, and I believe as I was answering this gentleman's question, I mentioned this too, the highly promotionally sensitive nature of the class generally means that prescribers are more likely to write products that they're actively engaged on, again, just given some of the nature of the treatment considerations within the class. But then also, as you have products that exit their exclusivity period, there's a lot of effort and support that goes into commercially supporting those products. And that takes the form of sampling programs that can be expensive and logistically challenging. There's commercial copay programs. There's all these types of things that you tend to see on products that are actively being promoted, but maybe not as much so on products that are post-LOE or for whatever reason have been deprioritized.

And as a very clear example on that, we saw this with Ponvory. When we acquired it, they had ceased all commercial support programs for Ponvory. And that was, in some ways, it impacted the business during the period of time which they didn't exist until we were able to reestablish them. So I think for all of those reasons, I think prescribers will be likely to migrate their patients to milsaperidone to make sure that they're getting the best of the support services possible and because it's the product that is being promoted actively.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Is there any financial incentive that you could provide where prescribers would be more incentivized to prescribe milsaperidone over Fanapt or over other products potentially as well?

Kevin Moran
CFO, Vanda Pharmaceuticals

No. Yeah. No, I don't think so. Both for the prescriber and the patient, I don't think there's any financial ramifications that we could necessarily navigate.

I think you do raise an interesting point, by the way, because we do see financial considerations potentially in other products outside of our products that impact behavior. But for us, no, I don't think. I think doctors are going to choose it based on what's best for their patients and what they're most easily going to be able to get them access to. Okay. And then you brought up the MDD data that are coming next year. Correct. Maybe just kind of level-set expectations. I mean, what is the clinical bar that you're hoping to hit? And then in the space, there has been some, we've had other companies that have been asked to run two phase III studies. You all are only running one phase III study.

So maybe just give us the rationale for why you have confidence that the FDA would be willing to accept a single phase III in MDD. Yeah. So first, maybe just a bit of context on the study itself. So a 500-person study, half to placebo, half to drug. Looking at the kind of, I would say, the normal expected, the measurements, MADRS just being the primary, and looking for a similar effect size that we would have seen in other programs. So very much, I would say, this is a well-worn path, and we're not necessarily whereas we try to innovate very often and almost at every turn. On this one, there's a well-worn path here that I think we're generally comfortable following.

There's also the mindset that we on the bipolar study for Fanapt implemented too, which is running a very deliberate study where we're working with good sites, recruiting patients that aren't professional patients that actually have the disorder and need to find a treatment. So for us, that kind of remains the focus as we're looking to do it. Then on the phase I, first phase or sorry, one phase III, first two phase III question, we've seen other products in the space have one phase III. So Symbyax is a recent example where they only ran one phase III program and our very own Fanapt for bipolar where we only ran one study. We'll have to see the FDA's response to that as we work through the process.

But it's also a class where, again, there's been a lot of these programs run before, which was similar to Fanapt on bipolar where there's been a lot of bipolar studies done in this class of drugs. And so there may be more acceptability for one relative to two just given kind of, again, the well-worn path of the space.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Okay. Understood. And then last question just to make sure that we cover it is you did have a big update on Hetlioz in jet lag recently, a couple of weeks ago maybe. What's your take there? I mean, what's your conviction that you guys will ultimately be able to get that across the goal line? Yeah. So I would say still too early to know.

Kevin Moran
CFO, Vanda Pharmaceuticals

We're kind of in the court decision there, which found that for the jet lag application, that the requirement would be either an approval or a hearing. And we did not receive an approval, and we've not yet had a hearing. And the ball is currently in the FDA's court in terms of the next steps there, and they have some different avenues that they could pursue. So probably too early to tell, but very, I would say, validating that the court found our arguments to be compelling and correct and very hopeful of what it could mean for both not just the jet lag and Hetlioz indication, but for other programs as well where we have similar fact patterns, and this could be applicable to them.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Okay. Great. Well, Kevin, thank you so much. Really appreciate it.

Kevin Moran
CFO, Vanda Pharmaceuticals

Yep.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

Thank you for the discussion.

Kevin Moran
CFO, Vanda Pharmaceuticals

Great. Thank you very much. I don't know if the mic's still on.

Olivia Brayer
Senior Biotech Analyst, Cantor Fitzgerald

I never know when it's going to.

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