Q1 2025 Vanda Pharmaceuticals Inc Earnings Call
Andrew Tsai, Charles Duncan, Mihael Polymeropoulos, Kevin Moran
Andrew Tsai, Charles Duncan, Mihael Polymeropoulos, Kevin Moran
Franz: Good afternoon, and welcome to the quarter one 2025 Vanda Pharmaceuticals Incorporated earnings conference call. I am friends and I'll be the operator assisting you today.
Franz: All lines have been placed on mute to prevent any background noise
Franz: After the speakers remarks, there will be a question and answer session. If you would like to ask your question during this time, simply press star one on your telephone keypad, and if you would like to withdraw your question, press star one again. Thank you.
Kevin Moran: I would now like to turn the call over to Kevin Moran, Vanda Chief Financial Officer
Please go ahead.
Speaker Change: Thank you, Francis. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals First Quarter 2025 Performance.
Speaker Change: Our first quarter 2025 results were released this afternoon and are available on the SEC's Edgar System and on our website www.VandaFarma.com In addition, we are providing live and archive versions of this conference call on our website.
Speaker Change: Joining me on today's call is Dr. Mahales Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Tim Williams, our General Counsel.
Speaker Change: Following my introductory remarks, Mihaels will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions.
Speaker Change: 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 security's laws
Speaker Change: Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties.
Speaker Change: These risks are described in the cautionary note regarding forward-looking statements, risk factors
Speaker Change: and Management's discussion and analysis of financial condition and results of operations, sections of our most recent annual report on form 10K, as updated by our subsequent court of the reports on form 10K.
Speaker Change: Current reports on Form 8K and other filings with the SEC, which are available on the SEC's Edgar System and on our website.
Speaker Change: We encourage all investors to read these reports and our other filings.
Speaker Change: 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
Speaker Change: With that said, I would now like to turn the call over to our CEO , Dr. Mahal's Polymeropoulos.
Mahalos Polymeropoulos: Thank you very much, Kevin, and good afternoon everyone. Thank you for joining us to discuss Vanda's first quarter 2025 results.
Speaker Change: Vanda has entered a new growth phase with multiple commercialized products and a READS innovative pipeline.
Fanat commercial growth has accelerated.
Speaker Change: Reaching multi-year highs with weekly prescriptions surpassed in 2000 at the end of April , as an increase in number of prescribers are adding fanat to their therapeutic armamentary.
Speaker Change: Our recent new drug application fileings for Tredipitant and Bissantive are a testament to our productive research and development pipeline.
Speaker Change: The addition of Imsydolimab alongside von Bory established an anti-inflammatory franchise that we believe has significant growth potential.
Speaker Change: These accomplishments have been possible because of our talented employees who for the first time surpassed 400 number at 22 year high.
Speaker Change: Some of the key operations on highlights started with commercial activities. On Phenapt, Phenapt was approved in the second quarter of 2024 for the acute treatment of bipolar 1 disorder.
Speaker Change: In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions increased by approximately 14% and FNAF net product sales increased by 14%.
Speaker Change: Additionally, new patient starts is reflected by new to brand prescriptions, increased by nearly three fold in the same period of time.
Speaker Change: FNAB total prescriptions for the week of April 25th, Ritzemouth's son of 2000, making FNAB one of the fastest growing atypical and the psychotics.
Speaker Change: Dhani has also announced an expansion of its psychiatry sales force to approximately 300 representatives.
Speaker Change: On Hetlius through the first quarter of 2025, Hetlius continues to retain the largest portion of market share despite generic competition for over two years.
Speaker Change: On Ponesomod, Vanda initiated commercial launch, OpenVori, for the treatment of relapsed forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patients and prescriptions reached a new record high since the initiation of Vanda's commercial launch.
Speaker Change: Vanda has reinforced the convoy sales leadership team and announced an expansion of which convoy sales force to approximately 40 representatives.
I will turn to regulatory and clinical development highlights.
Tradipitant, New Drug Application for Motion Sickness
Speaker Change: Accepted for filing by the U.S. for a drug administration with a prescription drug use to P.A.C. target action date of December 30, 2025.
Speaker Change: Fanat Marketing Authorization Applications for Bipolar-1 Disorder in schizophrenia were submitted to the European Medicine Agency in the fourth quarter of 2024.
Speaker Change: The headliest marketing authorization application in Smith McGannis submitted to the EMA in Q4 of 2024.
Be santi.
Speaker Change: New drug application for bipolar 1 disorder in schizophrenia, accepted for filing by the FDA with Epidephytharicate Action Date of February 21, 2026.
Speaker Change: Impsi-Dolimal Biologic License Application for the treatment of generalized porcelain psoriasis is expected to be submitted to the FDA in 2025.
Some clear highlights on fanat [inaudible]
Speaker Change: High pretensive, let's do a program we first discussed in the prior quarter.
Speaker Change: Vanda has initiated a study for fanat long-acting injectable as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon.
Speaker Change: Bissante, Melissa Peridot. The new drug application for Bissante for the acute treatment of bipolar one disorder and the treatment of schizophrenia was accepted for filing by the FDA with a pedophat target action date of February 21, 2026.
Speaker Change: Exclusively for Byzantine, including pending button applications, could expand into the 2040s.
Speaker Change: The Sunday is a new chemical entity which was initially identified as an active metabolite
Speaker Change: Pando discovered that Milsa Paredem, when administered orderly, quickly interconverged to alopeidem.
Speaker Change: In clinical studies, new subaida and our paida have been shown to be bioquivalent at both low and high doses, administered both in single and multiple dose types.
Speaker Change: There is also this clinical studies will be presented in late May at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona.
Speaker Change: The Bissanti Phase 3 Clinical Study for years as a once daily adracted treatment for major impressive disorder is ongoing. This also expected in 2022.
Speaker Change: Headleels, clinical programs in pediatric insomnia and the late sleep phase disorders are ongoing.
Speaker Change: The Vanda's marketing application, authorization for chapliers, and chapliers LQ for Smith-Meghan Syndrome in Europe is family with the European Medicines Agency.
Speaker Change: An investigational new drug application, Fort von Worry, has been submitted and accepted by the FTA in the fourth quarter of 2024 for the treatment of psoriasis and ulcerative
Speaker Change: So, a dipitent for the treatment of motion sickness, the NDA was accepted for filing by the FTA with the Pidufa target action date December 30, 2025.
Speaker Change: In the fourth quarter of 2024, Vanda initiated a technical study to study trundipidant in the prevention of vomiting induced by a GLP-1 analogue, that's where govy, semi-gluetide.
Results are expected in the third quarter of 2025 in the third quarter of 2025.
Speaker Change: Impsidolimum in February 2025, Vanda announced it entered into an exclusive global license agreement with an actress for the development and commercialization of Impsidolimum. That's the IL-36R Antagonist map.
Speaker Change: A BLA for General Light Force Laws Surreises is expected to be submitted to the FDA in 2025.
and some highlights on the L-State's programs.
Speaker Change: VQW-765, the Alpha-7 ecotainic acetylcholine receptor parcel agonist is currently in clinical development for the treatment of acute performance anxiety in social situations.
Vanda expects to initiate Phase 3 program in 2025.
Speaker Change: The Investigation Union Drug Application for VCA-894A in the treatment of sarcoma-di-toothed disease, axonal type 2S, and incaliting peripheral neuropathy, for which there is no available treatment was accepted by the FDA in 2024.
Speaker Change: Previously, in 2023, VCA8948 was granted orphan drug designation for the same indication. The Phase 1 clinical study for VCA8948 is expected to enroll the patient by mid-2025.
Kevin Moran: With that, I'll turn now to Kevin to discuss our financial results.
Thank you, Miles.
Speaker Change: I will begin by summarizing our first quarter of 2025 financial results. Total revenues for the first quarter of 2025 were 50 million, a 5% increase compared to 47.5 million for the first quarter of 2024.
Speaker Change: The increase as compared to the first quarter of 2024 was primarily due to growth in the FNAF revenue as a result of the bipolar commercial launch.
Let me now break this down by product.
Speaker Change: Phenatinet products sales were 23.5 million for the first quarter of 2025, a 14% increase compared to 20.6 million in the first quarter of 2024.
Speaker Change: The increase in phenaptic revenue between the first quarter of 2025 and the first quarter of 2024 was primarily attributable to an increase in volume, which was driven by increased total prescriptions or TRXs, as reported by Equivia Exponent.
Speaker Change: FNAF total prescriptions in the first quarter of 2025 increased by approximately 14% compared to the first quarter of 2024 and FNAF's new patient starts in the first quarter of 2025 as reflected by new to brand prescriptions or NBRX.
Speaker Change: Increased by nearly threefold compared to the first quarter of 2024 2004.
Speaker Change: Turning now to Hetlios, Hetlios net product sales were 20.9 million for the first quarter of 2025, a 4% increase compared to 20.1 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 price net of deductions partially offset by a decrease in volume.
Speaker Change: Of note, through the first quarter of 2025, Hetlius continues to retain the largest portion of market share despite generic competition for over two years now.
Speaker Change: Headless net product sales continue to be impacted by changes in inventory stockings at specialty pharmacy customers from period to period
Speaker Change: Going forward, HetliosNet 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.
Speaker Change: Further, HEPIO's net product sales may decline in future periods, potentially significantly related to continued generic competition in the US.
Speaker Change: Additionally, the company construed Hetlios Net Product Sales for the first quarter of 2025 and for the years ended December 31st, 2024 and 2023 to an amount not probable of significant revenue reversal.
Speaker Change: As a result, HeliosNet 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.
Speaker Change: And finally, turning to Pondboard. Pondboard net product sales were 5.6 million for the first quarter of 2025. A decrease of 18% compared to 6.8 million for the first quarter of 2024. The decrease in net product sales, as compared to the first quarter of 2024, was attributable to a decrease in volume. The increase in net product sales, as compared to the first quarter of 2024, was attributable to a decrease in volume. The increase in net product sales, as compared to the first quarter of 2024.
Speaker Change: As a reminder, pump boarding net product sales for the three months ended December 31, 2024, included approximately 3 million of variable consideration that is subject to dispute, but that the company believes is not probable of significant revenue reversal.
Speaker Change: As a reminder, we completed the acquisition of the U.S. and Canadian rights upon boring in December of 2023 and initiated the commercial launch upon boring in the third quarter of 2024.
Speaker Change: As such, this represents the second full quarter of convoy revenue recognition since the initiation of commercial launch activities. And significant progress in diversifying our product mix with innovative and value-generating products.
Speaker Change: For the first quarter of 2025, Vanda recorded a net loss of 29.5 million compared to a net loss of 4.1 million for the first quarter of 2024.
Speaker Change: The net loss in the first quarter of 2025 reflects expenses associated with the payment of 15 million dollars related to the exclusive global license agreement with the NAPTIS for the development and commercialization of Imtsudolamab and increased commercial activities associated with the commercial launches of FNAFTA and Pompori.
Speaker Change: From an income tax perspective, the net loss for the first quarter of 2025 included an income tax benefit of $7.9 million as compared to an income tax benefit of $0.5 million for the first quarter of 2024.
Speaker Change: Of other note on the taxides, 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 Change: The company generated a free tax loss for the quarter-ended March 31, 2025. If the company continues to generate free tax losses and or if the company's projections indicate free tax losses in future periods, the conclusion about the appropriateness of the valuation allowance could change in the future.
Speaker Change: An increase in the valuation allowance resulted in non-cash income tax expense during the period of change.
Turning now to operating expenses.
Speaker Change: Operating expenses in the first quarter of 2025 were 91.1 million compared to 56.7 million in the first quarter of 2024.
Speaker Change: The 34.4 million increase was primarily driven by higher R&D expenses associated with the payment of $15 million related to the exclusive Global License Agreement with an actous
Speaker Change: Higher SGNA expenses related to spending on vandus commercial products as a result of the commercial launches of finaft and bipolar 1 disorder and pangori in multiple sclerosis and higher expenses associated with legal and other corporate activities
Speaker Change: During 2024 and 2025, we commence the host activities as a result of the commercial launches of FNAF and bipolar one disorder and Pumbori in multiple sclerosis, including expansions of our sales force and the development of prescriber awareness and comprehensive marketing programs.
Speaker Change: S-GNA expenses may continue to increase in future periods as a result of the continued ongoing commercial efforts around finnapped in bipolar one disorder and pulmonary multiple sclerosis.
Speaker Change: Vince Cash, Cash equivalents marketable securities referred to as Cash, as of March 31, 2025, was $340.9 million, representing a decrease of $33.7 million compared to December 31, 2024.
Speaker Change: The decrease the cash reflects the payment of $15 million during the first quarter of 2025 related to the exclusive Global License Agreement with an app-dispore incidental amount.
Speaker Change: With regards to the launches of Phenaptom by Polar One Disorder and Pompoura Multiple Sclerosis, as I mentioned, launches were initiated in 2024 and we expect to continue to 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.
Speaker Change: Several lead indicators suggest a strong market response to our commercial launch of FNAF for Bipolar 1 Disorder, including new patient starts as reflected by NBRX, increasing by nearly threefold in the first quarter of 2025 as compared to the first quarter of 2024.
Speaker Change: In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions or TRXs increased by approximately 14%.
Speaker Change: As Mihael has mentioned, a particular note for the week of April 25th, 2025, FNAF reached the milestone of 2000 weekly TRXs, making FNAF one of the fastest growing atypical NS Electronics in the market on a 13-week to 13-week basis.
Speaker Change: Our FNAP Salesforce continues to expand. As of the end of the first quarter of 2024, our Salesforce numbered approximately 50 representatives. Currently, we have approximately 250 representatives and we have now initiated another phase of expansion which is expected to grow our Salesforce to approximately 300 representatives by the middle of this year.
Speaker Change: Speed expansions have allowed us to significantly increase our region frequency with prescribers To that end, face-to-face calls in April of 2025 were 43% higher than the monthly average of face-to-face calls in the first quarter of 2025 [inaudible]
Speaker Change: Again, face-to-face calls in April of 2025 were 73% higher than the monthly average of face-to-face calls in the fourth quarter of 2024 and face-to-face calls in April of 2025 were more than 500% higher than the monthly average of face-to-face calls in the first quarter of 2024.
Speaker Change: In addition to our Fanat Sales Force, we have established a specialty sales force to market palm-bori 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 palm-bori sales leadership team.
Speaker Change: A particular note in April 2025, new patient prescriptions grew to a record high since the initiation of Vanda's commercial launch.
Speaker Change: We have now completed over 1100 FNAF prescribed awareness programs and the number of programs completed in the first quarter of 2025 was 29% higher than the number of programs completed in the fourth quarter of 2024.
Speaker Change: Upon four, you prescribe awareness programs, continue to expand with 38% more programs completed in the first quarter of 2025 as compared to the fourth quarter of 2024.
Speaker Change: Before turning to our financial guidance, I would like to remind folks that with FNAF Tethyosom Pompori already commercially available, the Tribunant NDA for Motion Sickness accepted for filing by the FDA.
Speaker Change: The Milsa Paradone, or hopefully to be known under the brand name Basanti, NDA for 5 pull their 1 disorder and schizophrenia accepted for filing by the FDA, and a BLA for Impsidolimov expected to be submitted later this year. Vanda could have 6 products commercially available
Speaker Change: Turning now to our Financial Guidance, Vanda is reiterating its 2025 Total Revenue's Guidance and updating its 2025 Financial Guidance to include it year-end 2025 cash.
Speaker Change: Vanda expects to achieve the following financial objectives in 2025. Total revenues from FNAF, Hetlios, and Pambore of between 210 and 250 million year-end 2025 cash of 280 to 320 million.
Speaker Change: This revenue range would imply revenue growth in 2025 of between 6 and 26% as compared to the year of 2020-24 revenue.
Speaker Change: It is worth commenting that the quarterization of revenue in the remainder of 2025 will be impacted by several items including the Medicare Benefit redesigned portion of the Emplacian Reduction Act, which went into effect at the beginning of this year.
Speaker Change: The implementation of the benefit redesigns expected to negatively impact growth to net for the Medicare payer segment of our products, more significantly on FNAF 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.
Speaker Change: With FNAF and Pompori both in the early stages of commercial launch, FNAF for bipolar one disorder and Pompori for multiple sclerosis, revenue for the year is likely to be backweighted as these products continue to grow. Our expectation is that FNAF will grow on a quarterly basis with the trajectory accelerating as we move later into the year.
Speaker Change: This growth will potentially be offset by variability and or a decline in headliest revenue.
Speaker Change: The year in 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&D investments and potentially outsized commercial investments, which could continue to increase depending on the success of these commercial strategies.
Speaker Change: From a courterization 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.
Speaker Change: 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 FNAFT, bring Basanti and FNAFT LAI to market and expand the Basanti label to include major depressive disorder.
With that, I'll now turn the call back to Mahala.
Speaker Change: Thank you. And we will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again.
Speaker Change: If you are cold about to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.
Speaker Change: And your first question comes from Andrew Tsai, from Jeffries. Please go ahead.
Andrew Tsai: Hey, thanks. Good afternoon. Thanks for taking my questions. I appreciate the updates. I wanted to stick on the theme of Pipeline today. So notice that the Phase III MDD data for Millsaparadar Basanti could read out in 2026. So I'm just curious, what kind of placebo adjust a change on Madras or HamD would you want to see for a competitive profile?
Kevin Moran: Yeah, thank you, Andrew. We have not pre-specified a margin. Of course there are a number of under-depressant drugs.
and the variability on Hamdi, the sponsor of Madras.
Kevin Moran: 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.
Kevin Moran: And secondly, you're starting a social anxiety study phase three, seven, six, five, any color around the study design and how you power that study, and when could we get data for that?
Kevin Moran: Yeah, 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.
Kevin Moran: 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.
Kevin Moran: It is a classic design that you may have seen with others who develop similar drugs using the clear test in clear and naive pieces.
Great.
And my last question is on Tredibitant.
Kevin Moran: for Gastroparesis. It sounds like you do have correspondences with the FDA lately. What is your latest strategy of messaging?
Kevin Moran: around why this should be approved. And when can we hear?
Kevin Moran: 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 pedophile type decision later this year when you meet with them?
Speaker Change: Thank you. Yeah, thanks Andrew. So, it is still the same review cycle.
Speaker Change: that we got the complete response letter in September of last year. And as specified within the statute, we were given the opportunity for it here. That process unfortunately is very complex.
Speaker Change: because an opportunity for sharing by the FTA does not mean you get a hearing.
Speaker Change: It means that they're going to think about whether Cedar, the Review Division will propose to the commissioner whether to have it here or not.
Speaker Change: And then the commissioner will decide whether to have a hearing and if yes, the commissioner will conduct a hearing.
Speaker Change: You know, it sounds complicated. It is, it shouldn't be. And also, it is not a path commonly taken. In fact, to our knowledge, the FDA has held no hearings.
Speaker Change: for a long period of time for the approval of new drugs.
So, new filing is not required.
Speaker Change: We have requested to begin this process. Hopefully we're going to hear soon and answer whether they will propose to the commissioner to have a hearing or not.
Speaker Change: and then the commissioner will take that advice and make a decision.
Thank you very much.
Thanks, Andrew.
Speaker Change: And your next question comes from Charles Duncan, from Tantre, Fatsugeral.
Please go ahead.
Okay, thanks, Kevin, or Mahalas and team, congrats on...
Speaker Change: Nice for that number. I had a couple of questions on that and then for the play line.
With regard to FNAF, I've actually noticed some directed consumer...
a directed consumer campaign while catching those Stanley Cup playoffs.
Speaker Change: and I'm wondering if you could give us a sense of...
Speaker Change: First of all, how long that will run and kind of how to measure a return on the investment? Are you gaining traction with that and is it primarily for bipolar or schizophrenia patients? I imagine the former.
Speaker Change: Yes, indeed this quarter, I mean the first quarter, when you say the Director Consumer
Speaker Change: that addresses bipolar disorder in one commercial and punvori in a second one.
Speaker Change: and we also have made a concerted effort to increase the awareness of the Vanda brand that helps a lot with recognition by prescribers, basins, key opinion leaders.
We've been receiving very good feedback.
Speaker Change: It is validating where people in this field already know that this is a promotionly sensitive market, especially bipolar disorder, and therefore a direct to consumer awareness campaigns
Speaker Change: It would seem to be the case with the new to brand of key performance metrics, so congrats on that.
Speaker Change: I get some wondering, what would you focus attention to on that? I don't believe we've seen any data yet.
Speaker Change: on Basanti or Milsa Paradone. So, what is it that you anticipate being able to take away from that presentation with regard to, you know, the, you know, call it bio-equivalence?
Speaker Change: Yeah, so as we described earlier, the discovery that Vanda made as we're starting this active in the trouble light of all the paradigm, most of the paradigm.
We realise that surprisingly...
Speaker Change: We know almost no other example of the drugs and behaves like that.
Speaker Change: There is a quick interconversive in the body, so that most of the agents have been
Speaker Change: critical studies that are really the core of the submission of this new drug application. We've discussed this with the FTA and these are the studies that we will be published.
at the Scottsdale Conference.
So, in the studies, [inaudible]
One of them is a single acute dose close-over study
Speaker Change: And the second one is multiple doses to steady state, to the maximum dose, and then a crossover study.
Speaker Change: So with this, we complete the package that not only confirms that the two products are
Speaker Change: with each other at the low dose, but also it confirms that at the high dose, they are bioquivalent as well, which indirectly suggests also linearity.
Speaker Change: Very helpful, looking forward to that presentation. Last question is more strategy and that is I'm intrigued with the EMEA filings.
Speaker Change: for both FNAF as well as Hentlios and I guess I'm kind of wondering how do you see the market opportunity in Europe for...
Speaker Change: that anti-psychotic market and I'll call it on that need and your ability to...
Speaker Change: A market that drove over there and Hanby received 120-day questions. It's probably right on the edge, but have those come in yet?
Speaker Change: So I would love to say the last first. Yes, as you know, with the timing, the D120 questions have arrived and would just actively working through them right now.
However, there is a good appetite for the long-acting injectables.
Speaker Change: But he can't get there without having first the approval in the indication with the oral.
So we see this as a two-star one.
Speaker Change: Now, in terms of capabilities, I remind you that we have had a presence.
Speaker Change: Strong presence in Germany with our own marketing and sales force, Porsche had used in 1224 for the last 10 years.
So we have actually quite good understanding.
Speaker Change: Got it. Very good. Thanks for the guidance as well. I'll hop back in the tube.
Thank you so much.
Speaker Change: And your next question comes from Raghuram Selvaraju, from H.C. Wainwai.
Please go ahead.
Speaker Change: Good afternoon, this is Dan Al-Toram, Congrats on earning a seat and thanks for taking our question. So what is likely to be the total market opportunity for Byzantium and major depressant disorder? Do you think it would compete directly against teplido successful and I'd like to ask a follow-up if I could?
Definitely it is in the same space.
Speaker Change: of the study and the completed studies are very close to each other.
So it is about
Resistance
Speaker Change: treatment resistant depression and then adjunct treatment with disanti. Also to point out is that we're testing a one dose a day.
Speaker Change: And I remind you that from bipolar and schizophrenia acute indications we have used twice a day dosing.
and once a day convenient dosing will be there as well.
Speaker Change: Of course, we think there may be advantages to the fanat profile over Capelida and other competitors, especially on the...
Speaker Change: Tolerability regarding academia that you see with drugs like Brailer or peripheral neuropathy that you may see with Kaplida.
Speaker Change: Thank you, and for the follow-up, when might the lipid ester formulations of the dance of the clinic as long-acting and gestable formulations. Thank you.
Speaker Change: The Milti period on the Santi Long Act injectable is still in the formulation phase. But as we noted in the prior release, the fact that
Speaker Change: Bissanti has a terminal hydroxyl group. It makes it amenable to development of lipid esters.
Speaker Change: Length 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 Change: 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 Change: Yes, thank you all for joining us and we'll see you at the future call.
Speaker Change: Andrew Tsai, Charles Duncan, Mihael Polymeropoulos, Kevin Moran