Vanda Pharmaceuticals Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 7, 2025

There are 6 speakers on the call.

Operator

Good afternoon, and welcome to the Quarter One twenty twenty five Vanda Pharmaceuticals Incorporated Earnings Conference Call. I am Frans, and I'll be the operator assisting you today. 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.

Operator

I would now like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

Speaker 1

Thank you, Francis. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' first quarter twenty twenty five performance. Our first quarter twenty twenty five results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our site. Joining me on today's call is Doctor.

Speaker 1

Mihalas Paimaropoulos, our President, Chief Executive Officer and Chairman of the Board and Tim Williams, our General Counsel. Following my introductory remarks, Mihalas 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.

Speaker 1

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 ks as updated by our subsequent quarterly reports on Form 10 Q, current reports on Form eight ks 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. 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, Doctor.

Speaker 1

Mihalis Palimaropoulos.

Speaker 2

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's first quarter twenty twenty five results. Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated reaching multi year highs with weekly prescriptions surpassing 2,000 at the April as an increasing number of prescribers are adding Fanab to their therapeutic armamentarium. Our recent new drug application filings for Tradipitant and Vicente are a testament to our productive research and development pipeline.

Speaker 2

The addition of Imsidolumab alongside Ponvory established an anti inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees who for the first time surpassed 400 in number, a twenty two year high. Some of the key operational highlights starting with commercial activities. On Fanapt, Fanapt was approved in the second quarter of twenty twenty four for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt in this indication in the third quarter of twenty twenty four.

Speaker 2

In the first quarter of twenty twenty five as compared to the first quarter of twenty twenty four total prescriptions increased by approximately 14% and Fanapt net product sales increased by 14%. Additionally, new patient starts as reflected by new to brand prescriptions increased by nearly threefold in the same period of time. Fanapt total prescriptions for the week of April 25 reached the milestone of 2,000 making Fanapt one of the fastest growing atypical antipsychotics. Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. On HETLIOZ through the first quarter of twenty twenty five HETLIOZ continues to retain the largest portion of market share despite generic competition for over two years.

Speaker 2

On ponesimod, Vanda initiated commercial launch of PONVORY for the treatment of relapsing forms of multiple sclerosis in the third quarter of twenty twenty four. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has reinforced the Pulvari sales leadership team and announced an expansion of its Pulvari sales force to approximately 40 representatives. I will turn to regulatory and clinical development highlights. Tradipitant new drug application for motion sickness accepted for filing by the U.

Speaker 2

S. Food and Drug Administration with a prescription drug user fee act target action date of 12/30/2025. Fanapt marketing authorization applications for bipolar I disorder and schizophrenia were submitted to the European Medicines Agency in the fourth quarter of twenty twenty four. The HETLIOZ marketing authorization application in Smith McGinnis submitted to the EMA in Q4 of twenty twenty four. Visanti, new drug application for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of 02/21/2026.

Speaker 2

IMC Dolemo biologic license application for the treatment of generalized porcelain psoriasis is expected to be submitted to the FDA in 2025. Some clinical highlights on Fanapt. First, on schizophrenia, a Phase III program for the long acting injectable formulation of Fanapt for the treatment of schizophrenia relapse prevention is ongoing. Hypertension, that's a program we first discussed in the prior quarter, PANDA has initiated a study for Fanapt long acting injectable as a once a month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bisanti, nilsuperidone.

Speaker 2

The new drug application for Bisanti for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of 02/21/2026. Exclusivity for Vesante including pending patent applications could extend into the 2040s. Visante is a new chemical entity which was initially identified as an active metabolite of Candid discovered that milsaperedone when administered orally quickly interconverged to iloperidone. In clinical studies milsipiridone and iloperidone have been shown to be bioequivalent at both low and high doses administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May at the twenty twenty five American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona.

Speaker 2

The VISANTI Phase III clinical study for use as a once daily adjunctive treatment for major depressive disorder is ongoing. Results are expected in 2026. HETLIOZ clinical programs in pediatric insomnia delayed sleep phase disorders are ongoing. The Vandas marketing application authorization for HETLIOZ and HETLIOZ LQ for Smith Magenis syndrome in Europe is pending with the European Medicines Agency. An investigational new drug application for Punvari has been submitted and accepted by the FDA in the fourth quarter of twenty twenty four for the treatments of psoriasis and ulcerative colitis.

Speaker 2

Tradipitant for the treatment of motion sickness the NDA was accepted for filing by the FDA with a PDUFA target action date 12/30/2025. In the fourth quarter of twenty twenty four Vanda initiated a clinical study to study tradipitant in the prevention of vomiting induced by a GLP-one analogue, that's Wegovy semaglutide. Results are expected in the third quarter of twenty twenty five. Imsidolumab in February 2025 Vanda announced it entered into an exclusive global license agreement with Anaptis for the development and commercialization of Imcedolumab that's the IL-36R antagonist mAb. A BLA for generalized porcelain psoriasis is expected to be submitted to the FDA in 2025.

Speaker 2

And some highlights of the early stage programs VQW765, the alpha-seven nicotinic acetylcholine receptor partial agonist is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate Phase III program in 2025. The investigational new drug application for VCA-894A in the treatment of sarcoma disease, axonal type 2S, an inherited peripheral neuropathy for which there is no available treatment was accepted by the FDA in 2024. Previously in 2023 VCA-894A was granted orphan drug designation for the same indication. The phase one clinical study for VCA-894A is expected to enroll the patient by mid-twenty twenty five.

Speaker 2

With that I'll turn now to Kevin to discuss our financial results.

Speaker 1

Thank you, Miles. I will begin by summarizing our first quarter twenty twenty five financial results. Total revenues for the first quarter of twenty twenty five were $50,000,000 a 5% increase compared to $47,500,000 for the first quarter of twenty twenty four. The increase as compared to the first quarter of twenty twenty four was primarily due to growth in FNAP revenue as a result of the bipolar commercial launch. Let me now break this down by product.

Speaker 1

FNAP net product sales were 23,500,000.0 for the first quarter of twenty twenty five, a 14% increase compared to $20,600,000 in the first quarter of twenty twenty four. The increase in Fanapt revenue between the first quarter of twenty twenty five and the first quarter of twenty twenty four was primarily attributable to an increase in volume, which was driven by increased total prescriptions or TRxs as reported by Equivia Exponent. Fanapt total prescriptions in the first quarter of twenty twenty five increased by approximately 14% compared to the first quarter of twenty twenty four and Fanapt new patient starts in the first quarter of twenty twenty five as reflected by new to brand prescriptions or NBRx increased by nearly threefold compared to the first quarter of twenty twenty four. Turning now to HETLIOZ. HETLIOZ net product sales were $20,900,000 for first quarter of twenty twenty five, a 4% increase compared to $20,100,000 in the first quarter of twenty twenty four.

Speaker 1

The increase in net product sales relative to the first quarter of twenty twenty four was attributable to an increase in price net of deductions, partially offset by a decrease in volume. Of note, through the first quarter of twenty twenty five, HETLIOZ continues to retain the largest portion of market share despite generic competition for over two years now. Hetlioz net product sales continue to be impacted by changes in inventory stocking at specialty pharmacy customers from period to period. Going forward, Hetlioz net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, HETLIOZ net product sales may decline in future periods, potentially significantly related to continued generic competition in The U.

Speaker 1

S. Additionally, the company constrained HETLIOZ net product sales for the first quarter of twenty twenty five and for the years ended 12/31/2024 and '20 '20 '3 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 related to inventory stocking by specialty pharmacy customers are resolved. And finally, turning to POMVORY. PONVORY net product sales were $5,600,000 for the first quarter of twenty twenty five, a decrease of 18% compared to $6,800,000 for the first quarter of twenty twenty four.

Speaker 1

The decrease in net product sales as compared to the first quarter of twenty twenty four was attributable to a decrease in volume. As a reminder, Pomvori net product sales for the three months ended 12/31/2024 included approximately $3,000,000 of variable consideration that is subject to dispute, but that the company believes is not probable of significant revenue reversal. As a reminder, we completed the acquisition of The U. S. And Canadian rights to PONVORY in December of twenty twenty three and initiated the commercial launch of PONVORY in the third quarter of twenty twenty four.

Speaker 1

As such, this represents the second full quarter of PONVORY revenue recognition since the initiation of commercial launch activities and significant progress in diversifying our product mix with innovative and value generating products. For the first quarter of twenty twenty five, Vanda recorded a net loss of $29,500,000 compared to a net loss of $4,100,000 for the first quarter of twenty twenty four. The net loss in the first quarter of twenty twenty five reflects expenses associated with the payment of $15,000,000 related to the exclusive global license agreement with Anaptis for the development of imsadolumab and increased commercial activities associated with the commercial launches of Fanapt and Pounpourri. From an income tax perspective, the net loss for the first quarter of twenty twenty five included an income tax benefit of $7,900,000 as compared to an income tax benefit of $500,000 for the first quarter of twenty twenty four. Of other note on the tax side, the company assesses the need for evaluation allowance against its deferred tax assets each quarter through the review of all available positive and negative evidence.

Speaker 1

The company generated a pretax loss for the quarter ended 03/31/2025. If the company continues to generate pretax losses and or if the company's projections indicate pretax losses in future periods, the conclusion about the appropriateness of the valuation allowance could change in the future. An increase in the valuation allowance will result in a non cash income tax expense during the period of change. Turning now to operating expenses. Operating expenses in the first quarter of twenty twenty five were $91,100,000 compared to $56,700,000 in first quarter of twenty twenty four.

Speaker 1

The $34,400,000 increase was primarily driven by higher R and D expenses associated with the payment of $15,000,000 related to the exclusive global license agreement with Anaptis for imsadolumab, higher SG and A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Fanapt in bipolar one disorder and Ponvory in multiple sclerosis, and higher expenses associated with legal and other corporate activities. During 2024 and 2025, we commenced a host of activities as a result of the commercial launches of Fanapt in bipolar one disorder and Pounvari in multiple sclerosis, including expansions of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG and A expenses may continue to increase in future periods as a result of the continued ongoing commercial efforts around FNAF and bipolar I disorder and Ponvora multiple sclerosis. VENAS cash, cash equivalents and marketable securities referred to as cash as of 03/31/2025 was $340,900,000 representing a decrease of $33,700,000 compared to 12/31/2024. The decrease to cash reflects the payment of $15,000,000 during the first quarter of twenty twenty five related to the exclusive global license agreement with Anaptis for imsadolumab.

Speaker 1

With regards to the launches of Fanaptan bipolar I disorder and pomphoria multiple sclerosis, as I mentioned, launches were initiated in 2024 and we expect to continue the build out of our full commercial infrastructure with the impact of these commercial efforts expected to contribute to revenue growth in 2025 and beyond. We have already seen significant growth in our commercial activities. Several lead indicators suggest a strong market response to our commercial launch of FNAF for bipolar I disorder, including new patient starts as reflected by NBRx increasing by nearly threefold in the first quarter of twenty twenty five as compared to the first quarter of twenty twenty four. In the first quarter of twenty twenty five as compared to the first quarter of twenty twenty four, total prescriptions or TRxs increased by approximately fourteen percent. As Mihalis mentioned, of particular note, for the week of 04/25/2025, Fanapt reached the milestone of 2,000 weekly TRxs, making FNAP one of the fastest growing atypical antipsychotics in the market on a thirteen week to thirteen week basis.

Speaker 1

Our FNAP sales force continues to expand. As of the end of the first quarter of twenty twenty four, our sales force numbered approximately 50 representatives. Currently, we have approximately two fifty representatives and we have now initiated another phase of expansion, which is expected to grow our sales force to approximately 300 representatives by the middle of this year. These expansions have allowed us to significantly increase our reach and frequency with prescribers. To that end, face to face calls in April of twenty twenty five were 43% higher than the monthly average of face to face calls in the first quarter of twenty twenty five.

Speaker 1

Again, to face calls in April of twenty twenty five were 73% higher than the monthly average of face to face calls in the fourth quarter of twenty twenty four, and face to face calls in April of twenty twenty five were more than 500% higher than the monthly average of face to face calls in the first quarter of twenty twenty four. In addition to our Fanapt sales force, we have established a specialty sales force to market Pomvori to neurology prescribers around the country. We are currently in the process of growing the sales force to 40 representatives by the middle of this year and have recently reinforced the Pomvori sales leadership team. Of particular note, in April 2025, new patient prescriptions grew to a record high since the initiation of Vanda's commercial launch. We have now completed over 1,100 Fanapt prescriber awareness programs and the number of programs completed in the first quarter of twenty twenty five was 29% higher than the number of programs completed in the fourth quarter of twenty twenty four.

Speaker 1

PONFORY prescriber awareness programs continue to expand with 38% more programs completed in the first quarter of twenty twenty five as compared to the fourth quarter of twenty twenty four. Before turning to our financial guidance, I would like to remind folks that with Fanapt, HETLIOZ and PONFORY already commercially available, the trivipanent NDA for motion sickness accepted for filing by the FDA, the milsiperidone or hopefully to be known under the brand name Basanti NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA, and a BLA for Imsadolumab expected to be submitted later this year, Vanda could have six products commercially available in 2026. Turning now to our financial guidance. Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year end 2025 cash. Vanda expects to achieve the following financial objectives in 2025.

Speaker 1

Total revenues from Fanapt, Hetlioz and Pomvori of between $210,000,000 and $250,000,000 Year end 2025 cash of $280,000,000 to $320,000,000 This revenue range would imply revenue growth in 2025 of between 626% as compared to full year 2024 revenue. It is worth commenting that the quarterization of revenue in the remainder of 2025 will be impacted by several items including the Medicare benefit redesign portion of the inflation reduction act, which went into effect at the beginning of this year. The implementation of the benefit redesign is expected to negatively impact gross to net for the Medicare payer segment of our products, significantly on Fanapt and Helios. Note that this change is not linked specifically to Vanda, but is an industry wide change, which will have varying impacts on pharmaceutical companies. With Fanapt and Pompori both in the early stages of commercial launch, Fanapt for bipolar I disorder and Pompori for multiple sclerosis, revenue for the year is likely to be back weighted as these products continue to grow.

Speaker 1

Our expectation is that Fanapt will grow on a quarterly basis with the trajectory accelerating as we move later into the year. This growth will potentially be offset by variability and or a decline in HETLIOZ revenue. The year end 2025 cash guidance reflects the impact of the conditional investments that Vanda is currently making to facilitate future revenue growth, both in the form of R and D investments and potentially outsized commercial investments, which could continue to increase depending on the success of these commercial strategies. From a quarterization perspective, the cash burn could be higher in earlier periods as we make these conditional investments that will result in increased revenue in future periods. The potential market opportunity for our growing psychiatry portfolio is significant and necessitates the increased investments we are currently making to enhance the commercial profile of Fanapt, bring Basanti and Fanapt LAI to market and expand the Basanti label to include major depressive disorder.

Speaker 1

With that, I'll now turn the call back to Mihalis.

Speaker 2

Thank you very much, Kevin. At this point, we'll be happy to answer any questions you may have.

Operator

Thank you. And we will now begin the question and answer session. And your first question comes from Andrew Tsai from Jefferies. Please go ahead.

Speaker 3

Hey, thanks. Good afternoon. Thanks for taking my questions. Appreciate the updates. I wanted to stick on the theme of pipeline today.

Speaker 3

So noticed that the phase three MDD data for milseperidone or Basanti could read out in 2026. So I'm just curious what kind of placebo adjusted change on Madras or HAM D would you want to see for a competitive profile?

Speaker 2

Yeah, thank you, Andrew. We have not prespecified the margin. Of course, there are a number of antidepressant drugs and the variability on HAM D response or MADRS does not necessarily mean a drug is better than another because you do know the tremendous degree of variability in major depression studies. But the primary endpoint will be changed from baseline as compared to placebo.

Speaker 3

And secondly, you're starting a social anxiety study phase three for July. Any color around the study design and how you powered that study? And when could we get data for that?

Speaker 2

Yes. I'm not going to be able to answer this time the question about when to get data. The study is set to begin sometime later this year likely in Q3. In terms of design, I would refer you to the design of the study that we've conducted before and it is soon to be published. The paper has been accepted.

Speaker 2

And it is a classic design that you may have seen with others who develop similar drugs using the TRiR test in TRiEAR naive patients.

Speaker 3

Great. And my last question is on tradipitant for gastroparesis. It sounds like you do have correspondences with the FDA lately. What is your latest strategy and messaging around why this should be approved and when can we hear next steps? And then lastly, last to that is, in the best case scenario, do you refile the drug for review again or is the FDA going to make another PDUFA type decision later this year when you meet with them?

Speaker 3

Thank you.

Speaker 2

Yes. Thanks, Andrew. So it is still the same review cycle that we got the complete response letter in September of last year. And as specified within the statute we were given the opportunity for a hearing. That process unfortunately is very complex because an opportunity for hearing by the FDA does not mean you get a hearing.

Speaker 2

It means that they're going to think about whether, CIDR, the review division, will propose to the commissioner whether to have a hearing or not. And then the commissioner will decide whether to have a hearing and if yes, the commissioner will conduct a hearing. You know, it sounds complicated. It is. It shouldn't be.

Speaker 2

And also, it is not a path, commonly taken. In fact, to our knowledge the FDA has held no hearings for a long period of time for the approval of new drugs. So new filing is not required. We have requested to begin this process. Hopefully we're going to hear soon and answer whether CDER will propose to the commissioner to have a hearing or not and then the commissioner will take that advice and make a decision.

Speaker 3

Thank you very much.

Speaker 2

Thanks, Andrew.

Operator

And your next question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead.

Speaker 2

Okay.

Speaker 4

Thanks, Kevin or Mihalis and team. Congrats on a nice Fanapt number. I had a couple of questions on that and then for the pipeline. With regard to Fanapt, I've actually noticed some direct to consumer direct to consumer campaign while catching the Stanley Cup playoffs. And I'm wondering if you could give us a sense of, first of all, how long that will run and kind of how do you measure return on the investment?

Speaker 4

Are you gaining traction with that? And is it primarily for bipolar or schizophrenia patients? I imagine the former.

Speaker 2

Yes. Indeed, this quarter, I mean the first quarter, we initiated direct to consumer campaign that addresses bipolar disorder in one commercial and Punvari in a second one. And we also have made a concerted effort to increase the awareness of the Vanda brand that helps a lot with recognition by prescribers, patients, key opinion leaders. We've been receiving very good feedback and it is validating what people in this field already know that this is a promotionally sensitive market, especially bipolar disorder, and therefore direct to consumer awareness campaigns are fruitful.

Speaker 4

Yes, would seem to be the case with the new to brand key performance metrics. So congrats on that. Second question is Byzantine and the upcoming ASCP presentation. I guess I'm wondering what would you focus attention to on that? I don't believe we've seen any data yet on Bisanti or Melsiperidone.

Speaker 4

So what is it that you anticipate being able to take away from that presentation with regard to call it bioequivalence?

Speaker 2

Yeah. So as we described earlier, the discovery that Vanda made as we're studying this active metabolite of allopuridone, milsopuridone, we realized that surprisingly we know almost no other example of a drug that behaves like that. There is a quick interconversion in the body so that mulcaparibone is metabolized to iloperidone and vice versa. So we tested this hypothesis and eventually conducted these two critical studies that are really the core of the submission of this new drug application. We've discussed this with the FDA and these are the studies that will be published at the Scottsdale conference.

Speaker 2

So in the studies you're going to see two designs. One of them is a single acute dose crossover study and the second one is multiple doses to steady state to the maximum dose and then a crossover study. So with this we complete the package that not only confirms that the two products are bioequivalent with each other at the low dose but also it confirms that at the high dose they are bioequivalent as well which indirectly suggests also linearity.

Speaker 4

Very helpful. Looking forward to that presentation. Last question is more strategy and that is I'm intrigued with the EMEA filings for both Fanapt as well as HETLIOZ. And I guess I'm kind of wondering what how do you see the market opportunity in Europe for the antipsychotic market and I'll call it unmet need and your ability to market the drug over there? And have you received one hundred and twenty day questions?

Speaker 4

It's probably right on the edge but have those come in yet?

Speaker 2

So I will answer the last first. Yes, as you know with the timing, the D120 questions have arrived and we're just actively working through them right now. Now in terms of the expectation of market and market response in Europe, as you know already the pricing and reimbursement in Europe is very tough for antipsychotics. However, there is a good appetite for the long acting injectables but you can't get there without having first the approval in the indication with the oral. So we see this as a two step.

Speaker 2

Now in terms of capabilities, I remind you that we have had a presence, strong presence in Germany, with our own marketing and sales force for hep use in non-twenty four for the last ten years. So we have actually quite good understanding of Germany dynamics although actually we interact with other countries as well, but of course Germany is the focus given the more favorable reimbursement environment there.

Speaker 4

Got it. Very good. Thanks for the guidance as well. I'll hop back in the queue.

Speaker 2

Thank you, Sam.

Operator

And your next question comes from Raghuram Selvaraju from H. C. Wainwright. Please go ahead.

Speaker 5

Good afternoon. This is Dan Antaram. Congrats on the earnings season. Thanks for taking our questions. So what is likely to be the total market opportunity for Behzanti in major depressive disorder?

Speaker 5

And do you think it would compete directly against CAPLYTA if successful? And I'd like to ask a follow-up if I could.

Speaker 2

Definitely, it is in the same space. And the designs of this study and the CAPLITA studies are very close to each other. So it is about treatment resistant depression and then adjunct treatment with Bisanti. Also to point out is that we're testing a one dose a day, And I remind you that for bipolar and schizophrenia acute indications we have used twice a day dosing. So the population will be very similar to that of CAPLYTA and the once a day convenient dosing will be there as well.

Speaker 2

Of course, we think there may be advantages to the Fanapt profile of Recaplita and other competitors especially on the tolerability regarding akathisia that you see with drugs like Bralor or peripheral neuropathy that you may see with CAPLYTA.

Speaker 5

Thank you. And then for the follow-up, when might the lipid ester formulations of the Zantian to the clinic as long acting injectable formulations? Thank you.

Speaker 2

Thanks. The first long acting injectable which is now initiating the Phase III study is the Fanapt long acting injectable. The nilceperidone, Bisanti long acting injectable, is still in the formulation phase, but as we noted in the prior release, the fact that Bisanti has a terminal hydroxyl group, it makes it amenable to development of lipid esters. And as you know, various lengths of these lipid esters have translated to various lengths and duration of the drug in the blood where you can make doses once a month, maybe three months, and we've seen with other drugs six months. Thank you so much.

Speaker 2

Sure. Thanks.

Operator

There are no further questions at this time. I would now like to turn the call back over to Vanda management for the closing remarks. Please go ahead.

Speaker 2

Yes. Thank you all for joining us and we'll see you at a future call.

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Key Takeaways

  • Fanapt commercial growth accelerated with net product sales up 14% year-over-year, weekly prescriptions surpassing 2,000, and the sales force expanded to ~300 representatives.
  • HETLIOZ resilience maintained the largest market share despite over two years of generic competition and delivered a 4% sales increase, though future quarterly sales may vary with pharmacy inventory shifts and ongoing generics.
  • PONVORY launch progress in relapsing multiple sclerosis achieved a record high in new patient prescriptions in April 2025, generated $5.6 M in Q1 sales, and scaled its sales force to ~40 reps.
  • Pipeline momentum continued with Q4 2024 EMA filings for Fanapt and HETLIOZ, FDA acceptance of NDAs for Tradipitant (PDUFA 12/30/25) and Bisanti (PDUFA 02/21/26), plus a BLA for Imsidolumab expected in 2025.
  • 2025 guidance reiterated with total revenues forecast at $210–250 M (over 60% growth vs. 2024) and year-end cash of $280–320 M, underpinning expanded R&D and commercial investments.
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Earnings Conference Call
Vanda Pharmaceuticals Q1 2025
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