Vanda Pharmaceuticals Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 13, 2025

There are 6 speakers on the call.

Operator

Hello and thank you for standing by. At this time, I would like to welcome you to the Q4 twenty twenty four Banda Pharmaceuticals Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session.

Operator

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

Speaker 1

Thank you, Jericho. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' fourth quarter and full year twenty twenty four performance. Our fourth quarter and full year twenty twenty four 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 website. Joining me on today's call is Doctor.

Speaker 1

Michalis Paliimiropalis, our President, Chief Executive Officer and Chairman of the Board and Tim Williams, our General Counsel. Following my introductory remarks, Michalis 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 K as updated by our subsequent quarterly reports on Form 10 Q, current reports on Form eight 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, Doctor. Michalis Palimirojpalis.

Speaker 2

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's fourth quarter and full year 2024 results. As we discussed in our press release earlier this afternoon, strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of HETLIOZ and PONVOY. The FANABT long acting injectable program, the new drug application for BISANTI, middle zaparidone for bipolar disorder and schizophrenia along with its development for major depressive disorder have the potential to drive future growth in our psychiatry portfolio for many years to come. Tradipitant's new drug application for motion sickness was filed with a potential approval this year while we're pursuing approval in gastroparesis and the development of Tradipitant to improve tolerability of GLP-one analog with GOVI.

Speaker 2

Our anti inflammatory portfolio anchored by FONVORI was strengthened with the addition of imcedolumab from Anaptis, an IL36 receptor inhibitor for the treatment of generalized muscular psoriasis. We plan to file a BLA later this year while we're exploring registration in Europe and Japan as well as the development of this novel drug for other inflammatory disorders with an unopposed action of the IL-thirty six system. In 2024, we returned to revenue growth driven by the commercial launches in bipolar disorder and multiple sclerosis and advanced our development pipeline with a number of projects at or near marketing applications. All this was achieved by the hard work, ingenuity and efficiency of our organization and its wonderful people. I will now turn to Fanapt.

Speaker 2

Fanapt was approved in the second quarter of twenty twenty four for the acute treatment of bipolar one disorder. Vanda initiated the commercial launch of Fanapt in this indication in the third quarter of twenty twenty four. In the fourth quarter, as compared to the fourth quarter of twenty twenty three, new patient starts as reflected by new to brand prescriptions or NBRx increased by over 160% and FNAF net product sales increased by 18%. A dedicated specialty sales force of approximately 200 persons has been promoting Fanapt, supported by a speaker program to improve peer to peer awareness. Given the successful trajectory and consistent with other peers, we're currently in the process of further expanding our sales force to 300 representatives, which will allow for increase in both reach and frequency.

Speaker 2

In January of twenty twenty five, we began our direct to consumer advertising to increase general consumer awareness of NFAT. We expect product adoption to continue as more prescribers develop treatment experiences and identify candidate patients. Vanda also initiated a Phase III program for the long acting injectable LAI formulation of Fanapt in the fourth quarter of twenty twenty four. The long acting injectable once a month Fanapt is evaluated in relapsed prevention for schizophrenia, where the oral formulation has already been shown to be successful and is already included in the Fanapt prescribing information. While all products so far have been developed in double blind placebo controlled studies and while Vanda and FDA have agreed on this design, an IRB, Institutional Review Board, has objected to a placebo controlled design for schizophrenia maintenance.

Speaker 2

We're evaluating with the FDA ways to proceed outside of a placebo controlled study, which could include a bridging study with the oral formulation. This evaluation is not specific to Vanda and the outcome of this design will likely be required of others. Vanda plans to initiate a study for the FANAT long acting injectable injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. In the course of our extensive clinical program with Fanapt for over twenty years, we have now identified an unexpected but robust benefit in treating hypertension with Fanapt, Specifically, in a large meta analysis of placebo controlled studies, we have identified a rapid and sustainable effect in reducing systolic and diastolic blood pressure, especially among people with baseline hypertension. The effect size is comparable to effective antihypertensives.

Speaker 2

While the exact mechanism is not known, we believe that this effect is likely due to the mixed alpha serotonin and dopamine receptor antagonist observed with FNAF. We plan to initiate a study to evaluate this effect with the once a month injectable FNAF delayi in people with treatment resistant hypertension. It has been reported that medication non adherence in hypertension is a significant public health risk and as such, if we are successful in our studies, Fonaptil AI could become the first medication to address this large public health need. Additionally, Vanda submitted a marketing authorization application in Europe in the fourth quarter of twenty twenty four for FNAF and that is the European Medicine Agency for Bipolar one disorder and schizophrenia. I will now turn to BISANTI known as milsoparidone.

Speaker 2

Vanda expects to submit a new drug application for BISANTI for the treatments of acute Bipolar one disorder and schizophrenia to the U. S. Food and Drug Administration in the first quarter of twenty twenty five. Exclusivity, including pending patent applications, could extend into the 2040s. VESANTI is an active metabolite of alloperidone and has been extensively studied.

Speaker 2

In the last year, we have met with the FDA and agreed upon the clinical and manufacturing requirements and we're now prepared to submit a new drug application in the coming weeks. Vanda initiated a Phase III clinical study for VESANTI as a once a day adjunctive treatment for major depressive disorder in the fourth quarter of twenty twenty four. Results are expected in 2026. I will now move on to HETLIOZ, Dazenalkan. Vanda has initiated clinical programs in pediatric insomnia and delayed sleep phase disorder and these programs are ongoing.

Speaker 2

Vanda's MAA for HETLIOZ and HETLIOZ LQ for Smith Manganie syndrome is now pending with the European Medicines Agency. In addition, Vandy has continued to pursue the approval of HETLIOZ in sleep onset insomnia and the triphon of jet lag. Vandy has completed successfully multiple studies in these indications that have demonstrated substantial evidence of efficacy and a positive benefit risk profile. Vanda has requested an FDA hearing on the insomnia indication and an appeals court is expected to rule in the coming months on the jet lag application. PONVORY, Onasimod.

Speaker 2

Vanda initiated the commercial launch of PONVORY for the treatment of relapsing forms of multiple sclerosis in the third quarter of twenty twenty four. A new specialty sales force is now promoting PONVOYI for this indication across The United States. We believe that PONVOYI's profile when appreciated will drive the preferences of prescribers and patients. The sales force supported by a new speakers program for peer to peer awareness. Investigational new drug applications for PONVORE in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of twenty twenty four.

Speaker 2

Poreforti has been previously shown to be effective in treating acute episodes of psoriasis as well as preventing relapse. This study was contacted by Actelion before Vanda's acquisition of the product and the results have been published. Vanda is now finalizing the development program that could lead to a new drug application filing in this indication. Tradifitant, the new drug application for Tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of twenty twenty four. This application is supported by three positive studies in prevention of motion induced vomiting in actual sea travel conditions.

Speaker 2

We expect an FDA decision later this year. Vane has recently initiated a clinical trial to study Tradipitant in the prevention of vomiting induced by a GLP-one analog, Wegovy, that is semaglutide in the fourth quarter of twenty twenty four. A frequent and at times severe treatment emerging adverse event with GLP-one analogs is nausea and vomiting, which requires slower titration and delayed onset of effect. We're evaluating whether Tradipitant can prevent Wergovy induced nausea and vomiting and if it does, it could become a very useful product during GLP-one analog treatment initiation. VanDeck has now accepted the opportunity for hearing with the FDA on the approvability of the NDA for Tradipitant for the treatment of symptoms of gastroparesis.

Speaker 2

Bandai has identified a number of faults in the FDA review that led to a complete response letter and we believe that if allowed to be reviewed by experts, they would also reach the conclusion that Tradipitant can be a useful product in treating symptoms of gastroparesis. In the meantime, more than fifty patients are currently treated with Tradipitant through the expanded access program and many additional ones are being evaluated to initiate treatment. Imsidolumab. In February 2025, Vanda announced it entered into an exclusive global license agreement with Anaptis Bio and Aptis for the development and commercialization of IMSIDOLIMA that is an IL36 receptor antagonist monoclonal antibody. Vanda expects to initiate and complete the technology transfer activities in 2025 and to immediately begin preparing the biologic license application BLA and MAA for Generalized Porsullo psoriasis GPP for The U.

Speaker 2

S. And European Union. Generalized Porsullo psoriasis or GPP is a rare, severe skin disorder that is often caused by recessive mutations in the IL36RN gene, a regulator of the IL36 activity. The role of such mutations in heterozygous state, which are far more common, is not yet appreciated, but it may play a significant role in the pathogenesis and progression of other inflammatory skin conditions. We plan to file a BLA later this year while we're exploring registration in Europe and Japan and as well as the development of this novel drug in other inflammatory disorders with an unopposed action of the IL-thirty six cytokine system.

Speaker 2

Finally, on early stage program highlights, VQW765, an alpha-seven nicotinic acetylcholine receptor partial agonist is currently in clinical development for the treatment of acute performance anxiety in social situations. We have previously reported results from a Phase II study with encouraging outcomes in a model of acute performance anxiety. We plan to meet with the FDA in the coming months at an end of Phase II meeting and plan to initiate Phase III program in social anxiety disorder in 2025. The IND application for VCA-894A, an antisense oligonucleotide in the treatment of Sarcourt Marie Tooth disease, axonal type 2S, an inherited peripheral neuropathy for which there is no available treatment was accepted by the FDA in 2024. The Phase one clinical study for VCA-894A is expect to enroll this single patient by mid-twenty twenty five.

Speaker 2

In December 2024, Vanda announced that the FDA has granted orphan drug designation for VGT1849A, a selective antisense oligonucleotide based JAK2 inhibitor for the treatment of polycythemia vera, a form of a rare hematologic malignancy that is estimated to affect one in two thousand Americans. I will just review the key regulatory milestones Tradipitant NDA for motion sickness submitted in Q4 twenty twenty four, FANAPT MAA in Europe for Bipolar I disorder in schizophrenia submitted in Q4 twenty twenty four HETLIOZ MAA in Europe for Smith Magenie Syndrome submitted in Q4 twenty twenty four BISANTI, new drug application for Bipolar one disorder and schizophrenia expected to be submitted in Q1 twenty twenty five and IMCEDOLIMAN BLA in generalized postulosclerosis expect to be submitted in 2025. With that, I'll turn now to Kevin to discuss our financial results. Kevin?

Speaker 1

Thank you, Mahalos. I'll first discuss the results for the full year 2024 before turning to the fourth quarter of twenty twenty four. Total revenues for the full year 2024 were $198,800,000 a 3% increase compared to $192,600,000 for the full year of 2023. As Mahalos mentioned, this increase was primarily due to increased FNAF revenue as a result of the bipolar commercial launch and the introduction of PONVORI revenue following our acquisition of the product in December of twenty twenty three, partially offset by decreased TETLIOs revenue as a result of generic competition. Let me now break this down by product.

Speaker 1

FNAF net product sales were $94,300,000 for the full year 2024, a 4% increase compared to $90,900,000 for the full year 2023. The increase in net product sales relative to the full year 2023 was attributable to increased volume and increased price net of deductions. HETLIO's net product sales were $76,700,000 for the full year 2024, a 23% decrease compared to $100,200,000 for the full year 2023. The decrease relative to the full year 2023 was the result of continued generic competition in The U. S.

Speaker 1

HETLIO's net product sales as reported for the first quarter of twenty twenty three reflected higher unit sales as compared to recent prior periods. The higher unit sales during the first quarter of twenty twenty three resulted in a significant increase of inventory stocking at specialty pharmacy customers at 03/31/2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels remained elevated relative to inventory levels prior to the entrance of generic competition and continue to remain elevated throughout 2024. Going forward, HETLIO's net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, HETLIO's net product sales will likely decline in future periods potentially significantly related to continued generic competition in The U.

Speaker 1

S. Additionally, the company constrained HETLIO's net product sales for the years ended December 2023 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. PONVORI net product sales were 27,800,000 for the full year 2024 and include approximately $3,000,000 of variable consideration that may be 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.

Speaker 1

S. And Canadian rights to PONVORY in December of twenty twenty three. As such, this represents the fourth full quarter of PONVORY revenue recognition at Vanda and significant progress in diversifying our product mix with innovative and value generating products. For the full year 2024, Vanda recorded a net loss of $18,900,000 compared to net income of $2,500,000 for the full year 2023. The net loss for the full year 2024 included an income tax benefit of $4,000,000 as compared to an income tax provision of 3,800,000 for the full year 2024.

Speaker 1

Of note on the tax side, the company assesses the need for evaluation allowance against its deferred tax asset each quarter through the review of all available positive and negative evidence. The company generated a pretax loss for the year ended 12/31/2024. 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 a future period. An increase in the valuation allowance would result in a non cash income tax expense during the period of change. Operating expenses for the full year 2024 were $239,400,000 compared to $206,600,000 for the full year 2023.

Speaker 1

The $32,800,000 increase was primarily driven by higher SG and A expenses related to spending on Vanda's commercial products as a result of the commercial launches of FNAF in bipolar one disorder and POMVORI in multiple sclerosis and legal and other corporate activities as well as higher intangible asset amortization expense due to the amortization recorded on the POMVORI asset. During 2024, we commenced a host of activities as part of our commercial launches of Phenapton Bipolar I disorder and PONVORIAN multiple sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG and A expenses may increase in future periods as a result of the continued ongoing commercial efforts around Finapton Bipolar one disorder and Povorium Multiple Sclerosis. Vanda's cash, cash equivalents and marketable securities referred to as cash as of 12/31/2024 was $374,600,000 representing a decrease of $1,600,000 compared to 09/30/2024 and a decrease of $13,600,000 compared to 12/31/2023. Turning now to our quarterly results.

Speaker 1

Total revenues for the fourth quarter of twenty twenty four were $53,200,000 a 17% increase compared to $45,300,000 for the fourth quarter of twenty twenty three and a 12% increase compared to $47,700,000 in the third quarter of twenty twenty four. The increase as compared to the fourth quarter of twenty twenty three was primarily due to the introduction of PONVORY revenue following an acquisition of the product in December of twenty twenty three and increased FNAF revenue. FNAF net product sales were $26,600,000 for the fourth quarter of twenty twenty four, an 18% increase compared to $22,600,000 in the fourth quarter of twenty twenty three. The increase in FNAF revenue between the fourth quarter of twenty twenty four and the fourth quarter of twenty twenty three was primarily attributable to an increase in volume, which was driven by increased prescription demand or TRxs as reported by Equibia exponent and inventory stocking at the wholesalers. Historically, FNAF inventory at wholesalers has ranged between three and four weeks on hand as calculated based off trailing demand.

Speaker 1

As of the end of the fourth quarter of twenty twenty four, FNAF inventory at wholesalers was just above four weeks on hand. FNAF prescriptions in the fourth quarter of twenty twenty four increased by approximately 9% compared to the fourth quarter of twenty twenty three and FANAP new patient starts in the fourth quarter of twenty twenty four as reflected by new to brand prescriptions or NBRx increased by over 160% compared to the fourth quarter of twenty twenty three. FANAP net product sales in the fourth quarter of twenty twenty four increased by 11% as compared to $23,900,000 in the third quarter of twenty twenty four. FANAP prescriptions in the fourth quarter of twenty twenty four increased by approximately 7% compared to the third quarter of twenty twenty four. Turning now to HETLIOZ.

Speaker 1

HETLIOZ net product sales were $20,000,000 for the fourth quarter of twenty twenty four, a 5% decrease compared to $21,100,000 in the fourth quarter of twenty twenty three. The decrease in net product sales relative to the fourth quarter of twenty twenty three was attributable to a decrease in price net of deductions, partially offset by an increase in volume. HETLIO's net product sales in the fourth quarter increased by 12% as compared to $17,900,000 in the third quarter of twenty twenty four. And finally turning to PONVORI. PONVORI net product sales were $6,500,000 in the fourth quarter of twenty twenty four, an increase of 11% compared to $5,900,000 in the third quarter of twenty twenty four.

Speaker 1

The increase in net product sales was attributable to an increase in volume of units sold, partially offset by a decrease in price net of deductions. The increase in volume in the fourth quarter of twenty twenty four was partially attributable to a temporary inventory destocking in the third quarter at the specialty distributors and pharmacies due to the transition of distribution from Janssen to Vanda. As a reminder, we completed the acquisition of The U. S. And Canadian rights to POMVORI in December of twenty twenty three.

Speaker 1

For the fourth quarter of twenty twenty four, Vanda recorded a net loss of $4,900,000 compared to a net loss of $2,400,000 for the fourth quarter of twenty twenty three. The net loss for the fourth quarter of twenty twenty four included an income tax benefit of $1,600,000 as compared to an income tax provision of $700,000 for the fourth quarter of twenty twenty three. Operating expenses in the fourth quarter of twenty twenty four were $63,500,000 compared to $52,400,000 in the fourth quarter of twenty twenty three. The $11,100,000 increase was primarily driven by higher SG and A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Fanaptum Bipolar I disorder and Ponvory multiple sclerosis and legal and other corporate activities, partially offset by a decrease in R and D expense, primarily driven by lower spend on our Tradipitant development programs. Operating expenses in the fourth quarter of twenty twenty four increased by $4,800,000 as compared to $58,700,000 in the third quarter of twenty twenty four.

Speaker 1

This increase is primarily driven by higher R and D spend due in large part to increased expenses on our psychiatry programs and increased spending on Vanta's commercial products as a result of the commercial launches of FNAF in Bipolar I Disorder and Ponvoreum Multiple Sclerosis. During 2024, we commenced a host of activities as a result of the commercial launches of FNAF in Bipolar I Disorder and POMBIRIA multiple sclerosis and including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG and A expenses may increase in future periods as a result of the continued ongoing commercial efforts around FNFBipolar I disorder and POMBIRIA multiple sclerosis. With regards to the launches of phenoptin bipolar disorder and POMVORI multiple sclerosis, as I mentioned, the launches were initiated in 2024 and we expect to continue to build out 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 progress in our commercial activities.

Speaker 1

Several lead indicators suggest a strong initial market response to our commercial launch of finapctin bipolar disorder, including new patient starts as reflected by NBRx increasing by over one hundred and sixty percent in the fourth quarter of twenty twenty four as compared to the fourth quarter of twenty twenty three. Our FNAF sales force continues to expand. Currently, our sales force has grown to over 200 persons and we have now initiated a further expansion as Mahal has mentioned. In addition to our FNAF sales force, we have established a specialty sales force to market PONVORI neurology prescribers around the country. The expansion has allowed us to significantly increase our reach and frequency with prescribers and we've now had over 700 FNAF prescriber awareness programs completed in 2024 and the POMBORI prescriber awareness program continues to expand with over four times as many programs completed in the fourth quarter of twenty twenty four as compared to the third quarter of twenty twenty four.

Speaker 1

Before turning to our financial guidance, I would like to remind folks that with FANAP, HETLIOZ and POMVORI already commercially available, the Tradipitant NDA for motion sickness submitted to the FDA, the VASANTI NDA for Bipolar I disorder in schizophrenia expected to be submitted in the coming weeks and a BLA for IMCEDOLIMAV expected to be submitted later this year, Vanda could have six products commercially available in 2026. Turning now to our financial guidance. Banda expects to achieve the following financial objectives in 2025. Total revenues from Fanapt, HETLIOZ and POMBIRII of between $210,000,000 and $250,000,000 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 2025 will be impacted by several items including the Medicare benefit redesign portion of the Inflation Reduction Act, which went into effect as of 01/01/2025.

Speaker 1

The implementation of the benefit redesign is expected to negatively impact gross to net for the Medicare payer segment of our products more significantly on FNAFTA and Helios. Note that this change is not linked specifically to Vanda, but as an industry wide change which will have varying impacts on pharmaceutical companies. Insurance plan transitions. As patients adjust to new insurance plans to start the year, there may be some disruption in the first quarter. This is also a typical industry wide occurrence.

Speaker 1

And as I previously mentioned, FNAF inventory levels as of 12/31/2024 were higher than typical levels based on trailing demand. If wholesalers adjust their inventory to historical levels, this could have a short term negative impact on revenue in the period in which the destocking occurs. Given 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 increase depending on the success of these commercial strategies, Vanda is not providing 2025 cash guidance at this time. Vanda will continue to evaluate its ability to provide cash guidance in future periods. It is worth noting that the quarterization of cash balances will be impacted by several items including payments totaling $15,000,000 which were made to Enaptis in the first quarter of twenty twenty five upon entering into the global license agreement for imcedolumab, fees and costs associated with the filing of our applications with regulatory agencies in The U.

Speaker 1

S. And Europe, including the Basanti NDA for Bipolar one disorder and schizophrenia and the standard timing of certain items paid in the first quarter each year. Given the significant progress made during 2024 on establishing our commercial infrastructure and the commercial investments we expect to make in coming periods, Vanda is providing 2,030 revenue targets. For the psychiatry portfolio alone, Vanda is targeting annual revenue in excess of $750,000,000 in 02/1930, assuming the potential approval of VASANTI for the treatments of acute Bipolar one disorder and schizophrenia in early twenty twenty six, the potential approval of VASANTI for the treatment of MDD and the potential approval of FNAF LAI. Vanda is also targeting total annual revenue in excess of $1,000,000,000 in 02/1930.

Speaker 1

It is worth noting that the revenue economics for VASANTI are expected to be significantly favorable relative to the current revenue economics for Fanaxt. 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 FNAF, bring VASANTI and FNAFDA AI to market and expand the VASANTI label to include major depressive disorder. With that, I'll now turn the call back to Michalis.

Speaker 2

Thank you, Kevin. At this time, we'd like to answer any questions you may have.

Operator

Thank you. We will now begin the question and answer session. And our first question comes from the line of Charles Duncan from Cantor Fitzgerald. Please go ahead.

Speaker 3

Hey, good afternoon, Mahalos and team. Congrats on a good year of seeing the commercial turn as well as a ton of things going on with the pipeline, so lots of productivity. I had a question first on commercial and then pipeline. With regard to FNAF, I guess, I'm wondering as you see that Q on Q growth, where do you think you're picking up traction and what type of prescribers? And then I wanted to ask you about that 300 reps, the 50% growth in the sales force.

Speaker 3

I'm wondering if you think that will be sufficient to, I guess, compete with potentially larger pharma companies coming in marketing, obviously, CobEMPT, but also perhaps JNJ in the future with KEPLAYA?

Speaker 2

Yes. Thank you very much, Charles. So in terms of where the growth is coming from, the prescribers that are coming to FNAF are prescribers that have patients with bipolar disorder. And this is a difference from the smaller group of psychiatrists and psychiatric nurses that show schizophrenia patients. So it seems that the growth is exclusively coming outside of schizophrenia.

Speaker 2

In terms of the size of the sales force, as you know very well, this is a highly promotionally sensitive class of drugs and we have very recent examples of successful commercialization from some of our peers. Whether this is the right size sales force, I would venture to say likely it's going to be on the lower side, but certainly you want to build rapidly, but at the same time don't jeopardize the quality and very important training of the sales force. Now we do see the potential competition by more deep pocketed big pharma, of course, BMS with Coventry. At this time, they will be primarily focused on the only indication that they have schizophrenia and that is not our main focus now. And in terms of J and J, if they complete the acquisition of intracellular, certainly there's going to be a lot of strength, but it seems that the people there will be in patients with major depression if they succeed in securing the approval in that indication, which seems quite possible given the very nice data they have.

Speaker 3

Very good. Mahalas, that's helpful. Makes sense. With regard to the DTC that you started in January, I assume that's targeting then the bipolar patients. And do you think that those patients are amenable to picking up the messaging of the DTC and perhaps bringing that to their scribers and talking about financial?

Speaker 2

Yes. Thank you. Yes, the target is specifically for people with bipolar one disorder. And certainly we don't have to guess on the effectiveness in that before us there have been others, almost every other drug recently in the category, they have advertised to DTC, which increase not just awareness, but also confidence of support of the drug among patients. But we're also finding it is actually intriguing to prescribers themselves.

Speaker 2

So we believe that is a very effective way to increase awareness. And I would point out that Vanda has a significant track record in efficiently launching a DTC campaign and buying media. And I think that's going to become very important in the coming months. I would like to underscore, Kevin suggested that at this time we do not give a CASK guidance and this is primarily driven by trying to gauge what is the right size direct to consumer and you buy as you go. So we unlike some large companies, we're not doing pre buys at this time, we buy on demand and we're very carefully evaluating the return on our investment.

Speaker 2

So it is a measured approach, but we are prepared to make a significant investment provided a good ROI on the other side.

Speaker 3

Thank you for that information. On Byzantium, if I could ask a quick question. I'm intrigued with the one per day MDD study that you started towards the end of last year. I'm wondering if you have specific information on either Fanapt or milsoparidone that suggests that it may have activity in MDD as well as perhaps depressed patients with bipolar. What is the kind of rationale behind that Phase three?

Speaker 2

Yes. So of course, you know that we have a lot of experience on FNAF, gyloperidone with twice a day, but we also have experience in the utilization across different doses. So our studies have been primarily done on the higher dose side, twelve milligrams a day divided dose or twenty four milligrams a day as a divided dose. But our observation so far suggest that a large number of patients have been prescribed a monthly doses, which reflect a total in the day of approximately twelve milligrams on average. And we know that based on the pharmacokinetics and steady state levels that once a day twelve milligrams does not present any significant issues of peak to trough and tolerability.

Speaker 2

And the combination of all this suggested to us that a once a day administration of VSANTI will be a good approach in major depressive disorder. And as you can guess, it happens also to be likely more convenient than a twice a day dosing.

Speaker 3

For sure. Look forward to that. Final question, imcedolumab, congrats on the recent in licensing. I'm intrigued with that program, BLA in later on this year, but I think Enaptis and I'm not going to ask you to defend Enaptis, but I think they spoke about a BLA as early as October 2023 as having already been filed. So I'm wondering if you have a sense of what the delay I'm filing and if a pre BLA has been conducted or is that all the kind of stuff that you'll do once you fully accept all the information from them?

Speaker 2

Yes. I cannot comment on the first part of the question, but a pre BLA for meeting with the FDA on the GPP indication has been conducted. And upon review of this information, we're confident that we have in hand what needs to be had for filing. So of course, we're only a few days away, but I would say Anaptis is a great partner of this. Transition is ongoing quickly of materials, so we're confident we'll be able to file this BLA within this year.

Speaker 2

And I have to say Charles that maybe we get an opportunity at a future call. We have we're intrigued by the mechanism of action and we believe that the IL-thirty six cytokine system is a perhaps not fully explored therapeutic in a number of autoimmune inflammatory conditions. And of course, we understand the role in keratinocytes and generalized postural psoriasis. As I pointed out in my discussion, ZPP is caused by two bad genes, a recessive disorder. But of course, there is a much larger portion of the population that they're heterozygous carriers of a null mutation, which under some circumstances, it may lead to a relatively unopposed action of IL-thirty six.

Speaker 2

And there are theories of what this population may be. There may be a class of people with atopic dermatitis or psoriasis or actually other inflammatory conditions where IL-thirty six is important in monitoring intruders at barrier tissues, but more to be discussed in the future.

Speaker 3

Big pipeline, lots going on. Thanks for taking the questions. Congrats on the progress.

Speaker 2

Thank you, Jonas.

Operator

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

Speaker 4

Hi, thanks so much for taking my questions and congrats on all the recent progress. First of all, I wanted to start with a question around your anticipated timing for the development of the aloparidone long acting injectable. So specifically, I wanted to ask when you anticipate enrolling the first patient in that pivotal program and how long you expect enrollment to take as well as if you can provide any kind of updated outlook on the competitive landscape given the fact that this appears to be changing quite rapidly, although it obviously is also reflective of steadily expanding broader total addressable market? Thank you.

Speaker 2

Yes. Thank you very much for the question. And at the bottom, I would say, we agree with you that there appears to be a lot of need and large commercial opportunity around injectable antipsychotics and especially new entrants of molecules that have not been translated from oral to a long acting injectable like FENAP. In terms of the program, we are ready to go. And in fact, that program can be initiated imminently.

Speaker 2

The initial treatment period is about twelve week period of stabilization before we lead to the re randomization relapse prevention. And what I mentioned Ram is that the question from the IRB was that they felt no one should be running placebo controlled studies on a relapse prevention mode. And they offer that placebo people may be at some risk. We disagree with that, but nonetheless, it is the IRB and we are in total agreement with the FDA on what protocol is needed. And in fact, we are in agreement that this study, if successful, which we expect it to be, is the pivotal study required for registration.

Speaker 2

So we are actually waiting. We've launched this question to the FDA and they're working, I guess, on their policy side to see what this shift in the IRB means and what type of study may be required. But be it as it may, the placebo is the most involved study and we could end up with a more simple design where there is a bridging of sorts with the oral formulation. So no matter what it is, we can start the study very quickly. Now in terms of time into enrollment, as you know, that's hard to evaluate given the difficulty recruiting in general.

Speaker 2

But this study is a long study. Recruitment enlarged could take up to one year. And that means I think we've discussed before that we will not expect results, but in sometime in 2027, '20 '20 '7.

Speaker 4

Okay. And then with respect to the guidance that you provided today with on potential revenue in 2025, can you confirm that even the upper end of that guidance range does not actually include projected contribution from Tradipitant in any indication or imcedolumab. Is that correct?

Speaker 2

That is correct. The range guidance we're giving is solely based on the commercialized products today in the commercialized indications. And of course, we could be pleasantly surprised towards the upper end depending on the FANAP trajectory and upon Vori gaining speed. On HETLIOs, given the generic contribution, we have more tamed expectations.

Speaker 4

To what extent do you anticipate there to be a significantly larger number of generic competitors, generic purveyors of Tazemetion by the end of twenty twenty five versus the end of twenty twenty four?

Speaker 2

At this time, we do not expect that field to change outside of the three approved ones.

Speaker 4

Okay. And then just the last question is with respect to broader reimbursement changes. Any specific developments of note that you anticipate taking effect in 2025 that could significantly impact gross to net?

Speaker 1

Yes. Hey, Ram, it's Kevin. So on the main one, which we talked about in the scripted portion a bit is the introduction of the Medicare benefit redesign, which went into effect at the January. And the reminder there is previously where there was the donut hole concept and the manufacturer had a portion of that contribution until the patient had moved through the donut hole for the year. The benefit redesign has a different structure where for the catastrophic portion of the coverage, the manufacturer has either 10% or 20% contribution to that with some exceptions for different types of manufacturers and different types of patient populations.

Speaker 1

So So that went into effect at the January, as I mentioned, and was factored into our projections for 2025.

Speaker 4

Okay. Thank you.

Speaker 1

Thanks, Ram.

Operator

Our next question comes from the line of Andrew Kasai from Jefferies. Please go ahead.

Speaker 5

Hey, thanks. Good afternoon. I appreciate all the updates. First question is about the 02/1930 guidance. What exactly compelled you guys to provide that guidance today?

Speaker 5

And then within that $1,000,000,000 guidance, of course, $750,000,000 is coming from psychiatry. How much of that $750,000,000 is based on products or indications that have yet to be approved as opposed to currently approved products? Thanks.

Speaker 1

Thanks, Andrew. Yes, so maybe starting with the psychiatry portfolio first. Obviously with FNAF currently on the market doing about 100,000,000 this year and with the commercial investments we're making hoping to see growth as we obviously head into next year and beyond. But then even beyond that, we noted that included in that 02/1930 projection is the approval of VASANTI for Bipolar I disorder and schizophrenia hopefully next year. And then potentially a label expansion there in MDD beyond that, as well as the approval of Fanapt in LAI.

Speaker 1

So, and the one thing I also made note of in the script that's an important piece to that is that milsoparidone is expected to have or BISANATHY rather is expected to have very different economics than Fanapt currently has. And at a minimum that's due to the price reset that we would experience under Medicaid with a new drug application being approved. So all of those obviously we didn't provide kind of a breakout of the contributions of those

Speaker 2

individual factors, but hopefully that gives

Speaker 1

you a sense of what contributions would go into the seven fifty from existing product indications, future product indications. And then on the balance, obviously, with HETLIOZ and POMBIORI on the market, HETLIOZ, as Mahalos mentioned, where our expectations are a bit more tamed at least on the short term, and with PONVORI growing and hopefully even more so in the years to come. And also the possibility that we mentioned of an additional three products being on the market next year, including milsoparidone, but also Tradipitant and Imsidolimab. Those products also provide some of the bridge between the $7.50 and the 1,000,000,000.

Speaker 5

Thanks. And when we think about your overall business, where or when should we think the trough here is in terms of revenue and your total cash balance? Said another way, do you think the trough here already happened or could it be somewhere in 2025 or a little bit later?

Speaker 1

Yes. Thanks for the question there, Andrew. So obviously with our reported revenue for this year being growth from the year before, so we saw growth from about 193,000,000 up to about $199,000,000 in the most recent year and a midpoint of our guidance being $230,000,000 which would imply about a 15% growth on 2024. I would say that the trough here as you kind of expressed it is over the shoulder and our expectation is that we're growing revenue from here both with the existing products indications, but obviously all the products and indications that we're planning on bringing to the market in the short term and the long term.

Speaker 5

Okay. Thanks. And then last question is for HETLIOZ. If we stripped out the indications where generics you're facing generics, how much sales are you generating from the other formulations or indications where HETLIOZ is not facing genericization? So I guess the liquid formulation and the EU component, how much are those sales currently?

Speaker 5

Thank you.

Speaker 1

Yes. So Andrew, we haven't gotten into a breakout by geography or by indication. So I can't provide any further kind of color to that.

Speaker 5

Very good. Thank you.

Speaker 1

Thanks, Andrew.

Operator

There are no further questions at this time. I'll turn the call back over to the team.

Speaker 2

Well, thank you very much for joining us on this call. We'll see you on a future earnings call. Thank you.

Operator

This concludes today's call. Thank you for joining. You may now disconnect.

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Vanda Pharmaceuticals Q4 2024
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