Thank you for standing by. My name is Meg, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q2 2024 Vanda Pharmaceuticals, Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you. I would now like to turn the conference over to Mr. Kevin Moran, Vanda's Chief Financial Officer. You may begin.

Thank you, Meg. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals second quarter 2024 performance. Our second quarter 2024 results were released this afternoon and are available on the SEC's EDGAR system and on our website. In addition, we are providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mihael Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board; and Tim Williams, our General Counsel. Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions. Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainties. These risks are described in the cautionary note regarding forward-looking statements, risk factors, and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recent annual report on Form 10-K as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise except as required by law. With that said, I would now like to turn the call over to our CEO, Dr. Mihael Polymeropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's second quarter 2024 results. The beginning of the quarter was marked with a significant milestone: the FDA approval of Fanapt for the treatment of bipolar I disorder. This approval expands the commercial potential of Fanapt and lays down the foundation for our psychiatry portfolio. As a result of this development, we focused our operational efforts on expanding and strengthening our commercial organization to better position us to maximize the commercial value of the asset. In a short period, we have tripled the size of our sales force, significantly expanded our Fanapt speakers' program, and begun engaging with prescribers. In addition, we are building our marketing campaign, and we expect to reach full operational capacity in the fourth quarter of this year. In addition to these commercial efforts, the clinical development of the psychiatry portfolio is advancing, with a new drug application filing expected in early 2025 for milsaperidone, an active metabolite of Fanapt for the treatment of bipolar disorder and schizophrenia. We are also preparing to initiate the clinical program in major depression with milsaperidone in the fourth quarter of this year. The long-acting injectable program of iloperidone is continuing with the expected initiation of the Phase 3 study for the maintenance of treatment in schizophrenia later this year. We're excited about the prospects of our psychiatry franchise that we expect to provide significant value to patients and generate substantial revenue growth well into the future. With the acquisition of PONVORY from Janssen, and the full transfer of ownership to Vanda, we have also focused on building a commercial organization to promote PONVORY in the treatment of multiple sclerosis. We are now close to completing the hiring of a new specialty sales force and initiating patient support and marketing activities in the near future. We believe that PONVORY provides a useful and competitive option among disease-modifying treatment modalities for patients with multiple sclerosis. We are confident that increasing awareness among prescribers and patients will further drive utilization and allow for a return to revenue growth soon. We're also working towards initiating clinical programs in psoriasis and ulcerative colitis where PONVORY can become a significant treatment option as a once-a-day oral medication with a rapid onset of action as well as quick reversibility of its immune regulatory effect. Our third commercial product, HETLIOZ oral capsules for Non-24-hour sleep-wake disorder, continues to face revenue erosion due to the introduction of generic products. Nonetheless, patient loyalty to our quality product has allowed us to maintain a significant market share in this patient population. HETLIOZ LQ approved for children with Smith-Magenis Syndrome is not affected by generics competition and continues to serve the Smith-Magenis Syndrome community. We have recently applied for marketing authorization in the EMA for both HETLIOZ and HETLIOZ LQ for Smith-Magenis Syndrome. HETLIOZ is currently approved for Non-24 in the European Union and is actively commercialized in Germany. HETLIOZ is not facing generic competition in the EU at this time. In addition to our commercial efforts, HETLIOZ is under development for Delayed Sleep-Wake Phase Disorder, and HETLIOZ LQ is under development for the treatment of pediatric insomnia. Both disorders currently have no FDA-approved treatments and represent a significant unmet medical need. I will turn to our portfolio of assets under development and offer some highlights. The new drug application for Tradipitant for the treatment of syndromes of gastroparesis remains under review by the FDA with a PDUFA target action date of September 18, 2024. We continue to believe that the evidence provided in the NDA, including from qualified experts, constitutes both substantial evidence of efficacy and sufficient safety information to support the approval of Tradipitant to treat the symptoms of gastroparesis. We believe that the agency should convene an advisory committee to assist in reviewing this application with experts in the field, given the novelty of the mechanism of action pursued for this indication and the lack of approval of any drug in this indication in over 40 years. However, despite our repeated requests for an advisory committee meeting to consider the NDA, the FDA has yet to grant one. In the late cycle meeting held in June, the FDA stated that it would consider our request for an advisory committee meeting. We have followed up on this request several times but have yet to receive a response. On May 31, we received a Disciplined Review Letter, in which, among other comments, the FDA provided a preliminary notice that they had identified deficiencies that preclude discussion of labeling and post-marketing requirements and commitments, but that their comments do not reflect a final decision on the information reviewed and should not be construed to do so. We requested clarification from the FDA about whether we should expect labeling communication prior to the PDUFA date, but the FDA has yet to respond. Nonetheless, we remain confident in the body of evidence we have presented, and we await clarity on next steps by the FDA. On Tradipitant again, in the second quarter, we reported positive results for our second Phase 3 study in motion sickness, thus completing our clinical efficacy packages with two positive Phase 3 studies and a supporting positive Phase 2 study. The studies were conducted under real-world conditions in the coastal waters of the United States. We plan to seek FDA approval for Tradipitant in the prevention of vomiting in motion sickness later this year. With that, I'll turn now the call back to Kevin Moran to discuss our financial results. Kevin?

Thank you, Mihael. I'll begin by summarizing our financial results for the first six months of 2024 before turning to discuss the second quarter of 2024. Total revenues for the first six months of 2024 were $97.9 million, a 10% decrease compared to $108.6 million for the same period in 2023. This decrease was primarily due to the launch of generic versions of HETLIOZ, which we have discussed in some detail, partially offset by the introduction of PONVORY revenue following our acquisition of the product in December 2023. Fanapt net product sales were $43.7 million for the first six months of 2024, a 7% decrease compared to $47 million in the same period in 2023. This decrease in net product sales relative to the first six months of 2023 was attributable to a decrease in volume. Turning to HETLIOZ, HETLIOZ net product sales were $38.8 million for the first six months of 2024, a 37% decrease compared to $61.6 million in the same period in 2023. The decrease in net product sales relative to the first six months of 2023 was primarily due to a decrease in volume, partially offset by an increase in price net of deductions. HETLIOZ net product sales as reported for the first quarter of 2023 reflected higher unit sales compared to recent prior periods. The higher unit sales during the first quarter of 2023 resulted in a significant increase in inventory stocking at specialty pharmacy customers at March 31, 2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels at December 31, 2023 remained elevated relative to inventory levels prior to the entrance of generic competition and continued to remain elevated at March 31, 2024 and June 30, 2024. Going forward, HETLIOZ net product sales may reflect lower unit sales as a result of the reduction of elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, HETLIOZ net product sales will likely decline in future periods potentially significantly related to continued generic competition in the US. And finally, turning to PONVORY, PONVORY net product sales were $15.4 million for the first six months of 2024. As a reminder, we completed the acquisition of the US and Canadian rights to PONVORY in December of 2023. As such, this represents the second full quarter of PONVORY revenue recognition at Vanda and a positive step in diversifying our product mix with innovative and value-generating products. For the first six months of 2024, Vanda recorded a net loss of $8.7 million compared to a net income of $4.8 million for the same period in 2023. The net loss for the first six months of 2024 included an income tax benefit of $1.5 million compared to an income tax provision of $3.3 million for the same period in 2023. Operating expenses for the first six months of 2024 were $117.3 million compared to $109.4 million for the same period in 2023. The $7.9 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products due to the commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, and legal and other corporate activities, as well as higher intangible asset amortization expense due to the amortization recorded on the PONVORY intangible asset. During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Fanapt and PONVORY including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG&A expenses may increase in future periods as a result of the ongoing commercial launches of Fanapt and PONVORY, which were initiated in the third quarter of 2024. Vanda's cash, cash equivalents, and marketable securities referred to as cash as of June 30, 2024 were $387.7 million, representing a decrease of $0.6 million compared to December 31, 2023, and a decrease of $6.5 million compared to March 31, 2024. The change in cash during the second quarter of 2024 compared to the first quarter of 2024 was driven by the timing of cash in from customers for revenue and related payments of rebates to payers compared to recent prior periods. Turning now to our quarterly results. Total revenues for the second quarter of 2024 were $50.5 million, a 10% increase compared to $46.1 million for the second quarter of 2023 and a 6% increase compared to $47.5 million in the first quarter of 2024. The increase compared to the second quarter of 2023 was primarily due to the introduction of PONVORY revenue following our acquisition of the product in December 2023, partially offset by decreased HETLIOZ revenue due to the launch of generic versions of HETLIOZ. Fanapt net product sales were $23.2 million for the second quarter of 2024, a 4% decrease compared to $24.1 million in the second quarter of 2023. Fanapt net product sales in the second quarter of 2024 increased by 12% compared to $20.6 million in the first quarter of 2024. The increase in net product sales relative to the first quarter of 2024 was attributable to an increase in volume. Fanapt prescriptions in the second quarter of 2024, as reported by IQVIA Xponent, increased by approximately 2% compared to the first quarter of 2024. Turning to HETLIOZ, HETLIOZ net product sales were $18.7 million for the second quarter of 2024, a 15% decrease compared to $22 million in the second quarter of 2023. The decrease in net product sales relative to the second quarter of 2023 was attributable to a decrease in price net of deductions. HETLIOZ net product sales in the second quarter decreased by 7% compared to $20.1 million in the first quarter of 2024. The decrease in net product sales relative to the first quarter of 2024 was attributable to a decrease in volume, partially offset by an increase in price net of deductions. And finally, turning to PONVORY, PONVORY net product sales were $8.6 million for the second quarter of 2024, an increase of 26% compared to $6.8 million in the first quarter of 2024. The increase in net product sales was attributable to an increase in price net of deductions partially offset by a decrease in volume. As a reminder, we completed the acquisition of the US and Canadian rights to PONVORY in December of 2023. For the second quarter of 2024, Vanda reported a net loss of $4.5 million compared to a net income of $1.5 million for the second quarter of 2023. The net loss for the second quarter of 2024 included an income tax benefit of $1 million compared to an income tax provision of $1.1 million for the second quarter of 2023. Operating expenses in the second quarter of 2024 were $60.6 million compared to $48.9 million in the second quarter of 2023. The $11.7 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products due to the commercial launches of Fanapt and PONVORY and legal and other corporate activities. Operating expenses in the second quarter of 2024 increased by $3.9 million compared to $56.7 million in the first quarter of 2024. This increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products due to the commercial launches of Fanapt and PONVORY and legal and other corporate activities, partially offset by a decrease in R&D spend related to lower expenses on the Tradipitant development program. During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG&A expenses may increase in future periods as a result of the ongoing commercial launches of Fanapt and PONVORY, which again were initiated in the third quarter of 2024. With regards to the launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, as I mentioned, the launches were initiated in the third quarter, and we expect our full commercial infrastructure to be in place by the end of this year, with the impact of these commercial efforts expected to begin to impact revenue later this year. We have already seen tremendous progress in our commercial activities. As Mihael mentioned, our overall sales force size as of today is approximately three times larger compared to the end of the first quarter of 2024. The number of Fanapt prescriber awareness programs scheduled to be completed in the third quarter of 2024 is more than three times larger than the number of programs completed in the second quarter of 2024. The expansion has allowed us to significantly increase our reach and frequency with prescribers and early indicators of new Fanapt starts per IQVIA data appear positive. Turning now to our financial guidance. Vanda reinstates financial guidance and expects to achieve the following financial objectives in 2024. Total net product sales from Fanapt, HETLIOZ, and PONVORY of between $180 million and $210 million, year-end 2024 cash of between $360 million and $390 million. To note, HETLIOZ net product sales will likely decline in future periods potentially significantly related to continued generic competition in the US. Additionally, the company constrained HETLIOZ net product sales for the year ended December 31, 2023, and the first six months of 2024, to an amount not probable of significant revenue reversal. As a result, HETLIOZ net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration are resolved. With that, I'll now turn the call back to Mihael.

Thank you very much, Kevin. At this point, we will be happy to answer your questions.

Thank you. The floor is now open for questions. Your first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Yes. Hi, Mihael and team. Congrats on a good quarter of progress. And I really appreciate you reinstating the financial guidance for the second half of the year and all the color that you provided in the remarks. I had a couple of questions, Fanapt and then I'll hop back in the queue. But with regard to Fanapt, I know that the launch just started this year or this quarter. But I guess I'm wondering, is there any feedback that you can share with regard to prescriber perspective following the recent label expansion? I think Kevin alluded to this recently in terms of new patient starts. But any perspectives that you can give with regard to prescribing for Fanapt with that new label?

Yes. Maybe I'll start and have Kevin follow up on that. Thank you very much for joining, Charles. First of all, something environmental about this market is that despite the fact that there are a number of antipsychotics approved for this type of indication, there is still a significant unmet medical need for people who don't respond well or do not tolerate well other drugs. And this market is promotionally sensitive. But there is competition in the market for share of voice, and therefore it requires a significant investment, which we began making to increase awareness. It is important to note that while schizophrenia is a very significant indication, the bipolar space of indications with bipolar I disorder is actually far more frequent and encountered in prescriber offices outside necessarily of psychiatry. And therefore, it presents a much larger opportunity. We are, of course, receiving anecdotal evidence of excitement in learning more about the data, with very significant participation of prescribers and new prescribers in our speakers program. What we noted is the early signs based on IQVIA data we are referring to the trend on the NBRx (new prescriptions) which, as you know, is a metric of new starts, not refills, but new starts. And there we see positive results compared to prior quarters and positive results compared to last year as a whole. It is early, and as you know it takes some time to get the sales force out, create awareness, get the new starts, and get the refills. But typically, NBRxs are followed by NRxs (renewed prescriptions) and TRxs (total prescriptions). But we want to make sure that everybody understands this is the quarter where we're going to be first with a full sales force out. Our expansion continues, and our full marketing operations are not going to be in full swing until the fourth quarter of next year. So we're enthusiastic about the prospects of revenue growth, but we want to caution that it may take a few months before we get clear signs of the effect of our efforts.

That makes good sense to us. I was curious if you could share your thoughts on the possibility of a new competitor entering the psychosis treatment market, specifically with the muscarinic modulators and the potential approval of the candidate KarXT this fall. Are you prepared for that? What will be your response in terms of messaging with this increased competition? Do you believe the label is sufficiently differentiated and that Fanapt can stand alone to continue gaining market share?

Yes. Of course, we're looking at the competitive space and becoming more and more familiar with this new class of drugs. First of all, I would say it is terrific that after many years folks are working on new mechanisms of action to address unmet medical needs. So first I would say we welcome more enthusiasm in the space and more attention to treat these difficult disorders. I think the success of that drug will underscore the remaining unmet medical need in the space. In terms of differentiation, we have to wait and see the profile, but I would say a strong factor in differentiating Fanapt, not only from new entrants but also the drugs in the market is the tolerability profile. That is well understood. It is not a new entrant. The drug has been in the market for about 15 years since the first approval. So there's a lot of experience and familiarity. We’re looking at Fanapt as a well-known friend that now has a new utility. We welcome all new entrants, and we welcome more education of psychiatrists and other specialties around these markets and drugs.

And then one last question in terms of the pipeline with regard to Tradipitant. When you think about gastroparesis versus motion sickness, do you think gastroparesis is a nice to have or a need to have in terms of your view of where Vanda can be in a year with regard to commercial opportunities? Or is motion sickness perhaps a little bit more consistent with some of your marketing efforts thus far? And you mentioned filing later on this year. Does that depend on what the agency has provided you or will provide you with regard to a response on gastroparesis? Thank you.

Yes. I'll take the two parts of the question separately. We believe that Tradipitant has a useful effect in treating symptoms of gastroparesis, which is a significant unmet medical need. The testimony does not come just from our clinical trial results. All of them have been published. But also from the dozens of patients who have come over the years to request and be granted expanded access. We just celebrated our first patient four years on the drug with her testimony of the drug changing her life. So if you see it from the pain point in need, I think it is very important that Tradipitant makes it into the armamentarium of drugs for gastroparesis. But given the diversification of revenue that the company has and the deep and diversified pipeline, we can tolerate a delay in approval, which I guess that's the signal we can interpret now. When it comes to motion sickness, the motion sickness filing and approval are unlikely to depend on anything we learned from the FDA. The FDA will likely point to their questions around the strength of efficacy and will reference long-term preclinical safety and additional data they may need. However, when it comes to motion sickness, there's no question about efficacy; the drug prevents vomiting in the setting of motion sickness. And that's something that we have extensively discussed and agreed upon with the FDA in end of Phase II and PMDA meetings. Regarding safety, we think we're going to have a complete package both preclinical and clinical given the incidental and not chronic use of this drug. So we feel very confident that our package will be complete.

Very helpful. I have more questions but maybe give someone else the shot. Thanks.

Thank you. Your next question comes from Andrew Tsai from Jefferies. Please go ahead.

Hi. Thanks. Good afternoon. Thanks for taking my questions. The revenue guidance range is pretty wide, $30 million range despite us being two quarters in. So what exactly is your revenue guidance assuming for the type of quarterly sales growth for both PONVORY and Fanapt in the second half of 2024? What gets you to the high end of the guidance? Thanks.

I'll let Kevin take that.

Hey Andrew. Yes, so as we mentioned, obviously with the launch of Fanapt and PONVORY happening now in the third quarter, and as you mentioned, two quarters in. The trajectory of the launches and how quickly we begin to see results; if we start to see results fairly quickly, we think that we could end up at the top end of the range whereas if it takes a little bit longer time for those results to translate into revenue, it could come later in the year and therefore, be closer to the middle of the range or somewhere else in the range.

I see. And in terms of the cash guidance, it seems like there will be some expected cash burn year-over-year exiting 2024. But as we exit 2024 and head into 2025, do you think you can be cash flow positive? Or should we be expecting increased investments in the launches and pipeline growth to more than offset the revenues you bring in?

Yes. So first on the cash guidance for this year, our communicated guidance is that we will end the year between $360 million and $390 million. The high end of that range would be slight cash flow positive, very slight. And the bottom end of the range would be a burn in the neighborhood of $25 million to $30 million. And therefore, the midpoint is obviously a smaller number than that. If we end up at the top point of our revenue range, then we could even see it be right around the cash breakeven number or maybe a little bit better, a little bit worse. So that's just for the trajectory of this year. Obviously, we haven't provided guidance for next year, so you can only kind of speak to in the context of what we've communicated. But if we begin to see revenue growth as we hope for on these two products and we continue to make the investments that we've articulated, next year, we could see revenue growth that could necessitate additional investments or we could see it being efficiently converted into positive EPS.

Okay. Thanks. And for Tradipitant, let's just say it was approved later in September. Can you guys talk about your launch strategy?

Yes, absolutely. We actually have had quite a bit of time to work our launch plan, and we feel well prepared. Of course, we depend on de-labeling with the messaging. We understand well the target population. We have cultivated extensive relationships with key opinion leaders, and we understand the size of our sales force and the effort and size of the speakers program. We also have early plans for what a direct-to-consumer campaign can do in this indication.

I see. And the last question is, sales force is three times larger than earlier in the year. How many sales reps did you have earlier in the year, so we can do the math here?

Yes. The sales reps in the early part of the year were around 50, and so with it being three times larger we're a little north of 150 now.

Fair enough. Okay. Thank you. Congrats on the quarter.

Thanks, Andrew.

Thanks, Andrew.

Thank you. We have no more questions in queue. I will now turn the conference back over to Vanda management for closing remarks. Please go ahead.

Thank you very much for joining on our second quarter 2024 call, and we hope to see you again soon.

This concludes the conference call. You may now disconnect.