Good afternoon, everyone. Welcome to Zydus Life Sciences Limited, Quarter 1 FY25 Earnings Conference Call. Please note that all participant line will be in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks. Please note that this conference is being recorded, and I now hand over the conference to Mr. Ganesh Nayak, Executive Director of Zydus Life Sciences. Thank you, and over to you. Good afternoon, ladies and gentlemen. Welcome to our post-results teleconference for the quarter ended June 30, 2024. For today's call, we have with us Dr. Sharvil Patel, Managing Director; Mr. Nitin Parekh, Chief Financial Officer; Mr. Arvind Bothra, Senior Vice President, Investor Relations; and Mr. Alok Garg, Senior Vice President from the Managing Director's Office. Let me now give you a broad overview of the developments during the quarter. It's my pleasure to share that we commenced fiscal 2025 on a strong note, sustaining the growth momentum across the businesses during the quarter. Overall, we delivered a strong double-digit growth during the quarter. This, coupled with sustained profitability improvement, has helped us achieve the highest ever operating profit and margins during the quarter. Our India branded formulations business outperformed the market growth with 13% year-on-year growth. The consumer wellness business delivered an industry-leading double-digit growth during the quarter, aided by improved demand scenario and an extended summer season. Our US formulations business delivered a stellar performance, both on a sequential and year-on-year basis, driven by new launches and volume expansion in the base portfolio. Our international business continued its growth trajectory during the quarter. With that, let me take you through the financial numbers for the quarter gone by. We registered consolidated revenues of INR 62.1 billion, up 21% on a year-on-year basis and 12% on a quarter-on-quarter basis. EBITDA for the quarter was INR 20.8 billion, a growth of 38% on a year-on-year and 28% on a quarter-on-quarter basis. EBITDA margin for the quarter stood at 33.6%, which is an improvement of 430 basis points on a year-on-year and 410 basis points on a quarter-on-quarter basis. Net profit for the quarter stood at INR 14.2 billion, up 31% on a year-on-year and 20% on a quarter-on-quarter basis. We deleveraged our balance sheet during the quarter by repaying the entire debt. Now, let me take you through the operating highlights for the first quarter of FY25 for our key business segments. Our India geography, which comprises of the formulations and consumer wellness business, accounted for 37% of the total revenues during the quarter and grew 15% year-on-year. As mentioned earlier, our branded formulations business in India grew faster than the market during the quarter with 13% year-on-year growth. The business outpaced the market growth both in the chronic and acute segments. Portfolio of key pillar brands and innovation products registered strong volume growth, driving the overall performance during the quarter. We launched 10 new products, including line extensions, with 3 first-in-India launches. We retained our leadership position in the nephrology and in nephrology, and remained the fastest growing Indian company in oncology in the IPM. The business grew faster than the market in key therapies of cardiology, gynecology, derma, respiratory, anti-infectives, and super specialty therapies of oncology and nephrology. Contribution of chronic portfolio has increased consistently over the last several years and stood at 41.3% as per IQVIA, MAT June 2024, which is an improvement of 430 basis points over the last three years. Our consumer wellness business recorded revenues of INR 8.4 billion, up 21% on a year-on-year basis. The growth was broad-based and largely driven by 17% volume growth. The personal care segment, which comprises of Nycil and the Everyuth brands, continued to deliver robust performance with yet another quarter of strong double-digit growth. Food and nutrition segment witnessed recovery during the quarter and posted double-digit growth as well. Gross margins continued to improve both sequentially and on a year-on-year basis. Now, let me take you through the performance of our U.S. formulations business. The business accounted for 51% of the consolidated revenues during the quarter, with revenues of INR 30.9 billion, up 23% on a sequential basis. We launched seven new products during the quarter. New launches for the quarter include the launch of our second 505(b)(2) product, namely, Zituvimet, in the area of metabolic disorder management and Mirabegron ER tablets. We filed five additional ANDAs and received approval for six ANDAs, including two tentative approvals during the quarter. On the international markets front, the demand scenario remained strong across key markets, despite ongoing political and economic challenges in some of the countries. Overall, the business posted revenues of INR 5.3 billion, up 9% year-on-year. On the operations front, the U.S. FDA has classified two of our injectable facilities located in the Ahmedabad SEZ and at Jarod near Baroda, as official action indicated, which is OAI. We are working closely with the U.S. FDA to implement the necessary corrective actions as required. Now, this concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers across businesses, as well as initiatives in our innovation program. Thank you. Thank you, Mr. Nayak, and good afternoon, ladies and gentlemen. It is a pleasure to have you all here on the call today. We are pleased with our performance during the quarter. All our businesses continued their robust growth journey from the previous fiscal and performed on expected lines, with a focus on fulfilling diverse healthcare needs of the customers across the market. We remain committed to strengthen our core business and explore newer avenues to generate better outcomes for our patients. On the India formulations front, our efforts are directed towards expanding the presence across focused therapies, and in turn, serve a larger set of customers. We have successfully leveraged our rich and diverse portfolio of innovation products to offer novel solutions to the patients to satisfy their unmet healthcare needs. We have been conducting various patient support programs and activities to create greater awareness among patients, particularly in the area of the unmet healthcare needs. In the U.S., multiple building blocks, such as a comprehensive portfolio of generics across dosage forms, capability to deliver novel solutions to patients through the LiqMeds acquisition, the specialty space, and investments in rare disease space, are now in place. This will greatly enhance our ability to address diverse patient needs. This, coupled with strong customers' relationships, a network of regulatory-compliant manufacturing facilities, and an agile supply chain, will ensure sustained growth trajectory for the U.S. business going forward. On the international market front, our focus remains on expanding the presence in selected therapies across key emerging markets by leveraging our global R&D portfolio of generics and specialty products. Our innovation pipeline across different areas continues to make progress and achieve the desired milestones. With this, let me share some material developments on our innovation efforts during the quarter. On the NCE research front, during the quarter, we completed patient recruitment for the phase IIb/III clinical trials of Saroglitazar Magnesium for primary biliary cholangitis indication, and initiated the phase IIb clinical trial of Saroglitazar Magnesium for metabolic dysfunction-associated steatohepatitis, which is known as MASH, indication for the U.S. We also completed patient recruitment for phase II clinical trials of Usnoflast, earlier known as ZYIL1, for amyotrophic lateral sclerosis, which is known as ALS indication, during the quarter. In the biotech space, we submitted a market authorization application for one of the monoclonal antibodies to the Indian regulator. On the novel biologics front, we initiated a phase I clinical trial in India for an anti-properdin molecule during the quarter. Recently, in the month of July, we received marketing approvals from the Mexican authorities, regulatory authorities, for two products: Bambevi, which is the biosimilar of bevacizumab, and the brand name Mametra, for the biosimilar of trastuzumab. On the specialty 505(b)(2) development front, recently in the month of July, we received final approval for our third NDA, Zituvimet XR, which is the sitagliptin metformin extended release tablets in the area of metabolic disorder management. With this approval, we now have all three NDAs of the sitagliptin and combination franchise approved through the 505(b)(2) rule. All the three NDAs have received first cycle approvals. Thank you, and now we can start with the Q&A session. Over to the coordinator for the Q&A. Thank you very much. We'll now begin the question- and- answer session. Anyone who wishes to ask questions may raise your hand from Participant tab on your screen. Participants are requested to use headphones or earphones while asking questions. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Please start. Okay. Yes, the first question is from Yash Gandhi. Hello. Hi, am I audible? Yes. Thanks for the opportunity. So, sir, congratulations again on a great set of numbers. So I think, this quarter, we've got 33% EBITDA margin, you know, it's one of the highest companies ever seen in the history. So I just want to understand the sustainability of this sort of margin going the next two quarters, for the year. I think obviously this quarter has been an exceptionally good quarter on the margins front, and, as we have stated earlier, that on the last year, we ended on a high with a 27.5% margin. And with looking at the phasing of the coming year, we expect to see an improvement in the margin by 100-150 basis points from FY 2024 margin. Okay, okay. And so on the, again, on the U.S. business, you know, so this year we've grown 26% year-on-year. This is an excellent growth. How do you see the trajectory of the US formulation business doing this year? So we see healthy, double-digit growths for the U.S. business during the coming financial year, this financial year, I mean. Okay, okay. Got it. That was it. Thank you. Thank you. The next question is from Kunal. Hello. Can you hear me? Yeah, good afternoon. So first question on the revenue guidance that we had provided for FY25, we had said, almost around high teens kind of top line growth that we expected. Since the first quarter has been, you know, meaningfully above that, are we revising it or we are staying with the same guidance? We continue to believe that we will deliver high teens growth for this year. Oh, oh. And on the specialty portfolio across two geographies. One is U.S., wherein we have now, you know, few commercialized products, et cetera, right? Zokinvy, et cetera. So would you be, you know, quantifying the current contribution of our specialty portfolio in U.S.? I think it's still in the very early stages. As I said, the patient acquisition or the, you know, finding new patients is a slow process in the U.S. So once, once it becomes sizable and meaningful, we will obviously talk about it differently, but right now, it's it doesn't form a major part of the overall revenue. Last one on the India business. You know, we have a portfolio of, you know, specialty products with our in-house research, like Saroglitazar, and some of them have been first in the market by similar launches, et cetera, right? So to that extent, we have also said that that portfolio has grown very strongly. Could you quantify the current contribution of that portfolio for us? I don't think, you know, our focus on India is not driven by dosage form. It's a therapy and disease focus, so and brand focus. So I don't think we do it that way. But as I said, they do form an integral part of the overall future innovative portfolio that we have, which is both, as you mentioned, the Saroglitazar and the breast cancer and other oncology therapies that we are working on. So it's more a disease area, where we look at it and how much share of that area we do have. And as we alluded, like in oncology, we are now the largest and the fastest growing organization, and similarly in nephrology and other segments. Obviously, all led by both the proprietary products that we have, but also the products that are required beyond just the couple of new drugs that we have. Is it fair to say that there will be more launches coming, right? And hence, this portfolio will keep getting bigger and bigger, which is high growth for us. Yes, that is a right statement. We do expect these products to become the largest brands for the organization, which will obviously mean that they'll form a larger part of the overall portfolio. Sure, sir. Thank you. I have more question as well. Can the coordinator ensure that all others are on mute? Yes. Because there's some, you know, noise coming from other people talking. Thank you, Kunal. The next question is from Neha. Yeah, thanks for taking my question. So my, you know, given you're maintaining your revenue, your margin guidance of 150 basis points margin expansion, is it fair to assume that the cost base that we have seen, in this quarter, let's say the R&D cost or the other operating cost, R&D would materially increase from here, you know, the SG&A cost would remain at these levels? Because, you know, this was a seasonally strong quarter for the India business as well as U.S. we did higher. So how should we think about the operating cost, you know, from a run rate perspective? Excluding R&D, Neha, there has been increase in this particular quarter, but about INR 125 crore in this quarter are of one-off natures... And therefore, I think INR 1,200 crore-INR 1,250 crore other costs, excluding R&D, would be the right basis for you to project. What is this INR 125 crore related to, sir, the one-off that you're mentioning? There are some ERF-related costs, there are some legal cost provisions, there are some project-related consultancy assignments, some professional fees. Okay. Many items within that- Okay, understood. But they are recurring nature. Okay. On the R&D, how should we look at the R&D, given we have, you know, the patient recruitment completed for two of our, you know, NCE products? As I said, our expectation is that we will... I mean, we will see around 8, an 8% kind of spend on R&D, and that's what we hope to maintain. 8% of sales for a full year basis? Yeah. Yeah. Understood. Understood. My second question, you know, is on the U.S. business. Obviously, you know, this quarter we had the benefit of, you know, the Revlimid as well as, you know, Mirabegron. As we think about the subsequent, first, or in this quarter, was there any improvement in the base business besides Revlimid and Mira? And was Revlimid flattish quarter on quarter, higher quarter on quarter? Any qualitative color there? Revlimid was obviously higher quarter-over-quarter, and there was a ramp-up to the base business also. Okay, understood. And as I think about, you know, the next three or four quarters, you know, other than Mametra, can you give us some color on what sort of launches we should be expecting, any other meaningful launch that we should be seeing? You know, anything that you can provide us on the U.S. you know, for the base business. As I said, you know, we do expect a double-digit growth in the U.S. and that factors in obviously our current base business and new products launches. Okay. So, how many launches should we be expecting this year, sir? We, for the full- year, we expect 25, around 25+ launches. Okay. Understood. And my last question, you know, one, given we have ample amount of net cash that we are sitting on, you know, sorry, given the ample amount of cash generation, how should we look at capital allocation strategy, you know, for future growth? What would be two or three, two or three key areas that you would be focusing on for inorganic growth opportunities? And, you know, any ticket size that you're thinking would be, is something that you'd be comfortable with. Yeah. So I think, as I had also tried, to speak about in the last quarter, I think a key focus will be, scaling up our specialty business in the U.S. And for that, obviously, we will look to see how do we deploy, efficiently our capital to, not only scale up the business, but also have a diversifiedly large business on the specialty front. The second area is India. India, we are very, we've done well, we understand the business well. We will continue to see if there are opportunities, In India, both, from the brand side or some other adjacencies. And, recently, you know, with the, you know, last five years, good scale-up of our international business, and also good profitability that we are seeing, we do believe there can be specific opportunities in the international businesses that we would look to do. Beyond that, I think, as I said, we have transformed from just being a pharmaceutical business to more of a life sciences organization. And that would mean that how do we create the right solutions for the patients in different areas will become important. So going beyond the pill becomes very critical for us. So whether it is companion diagnostic, med devices or medical med devices or direct-to-patient services, we will be looking at many of these opportunities to scale up our business further. Understood. Okay. Thank you so much, sir. Thank you, Neha. The next question is from Binu. Hi, good evening. Good evening. I have a few questions. To start with, on Mirabegron, Sharvil, how do you look at it? Binu, your voice is not audible. Can you speak up? Hello, is it better now? Yes. Okay, great. How do you look at the timelines on Mirabegron? I know it's difficult because litigation is going on, but would you think this can be a few quarters opportunity or, you know, will it last till the next patent expiry? How do you look at it? I think you answered it, saying it is difficult to answer that question. But, at least I think short term, at least for the next couple of quarters, it is a it is, what it is today, but little longer term is still very difficult to answer, sir. Okay. Second, on this product, Opsumit or macitentan, I believe you had an FTF in that. Is that still valid? Because I saw somebody got an approval whom I thought was not an FTF. So I won't have a direct answer on this. So I mean, better my team gets back to you on it specifically, so I don't give it. But I do, I do remember that we did have some first to file status, but I'll request my team to give you more specific details on that. Sure, sure. And, regarding Cabometyx, which we recently in-licensed, I believe there was quote wording expected some time around this time. Is it, has it come yet? I'm sorry, could you repeat the molecule? Which one did you say? Cabometyx. Which we in-licensed recently. The one- Amgen. Amgen Yeah, the from MSN, right? Yeah. Yeah. So I think that's still under litigation, so as and when we have any outcome on that, we will, we can discuss that. But, obviously there are some... It seems to be a good product for the future. Finally, on Saroglitazar PBC indication, when do you expect the readout? Any timeline? It will be in the next financial year, hopefully in the end of, I mean, second quarter of next financial year. Okay, so at 5:26. So filing would be, filing next year, so it could be an FY 2027 opportunity if everything goes well. Yeah. Okay. Thank you. I'll jump back. Thank you. Thank you. The next question is from Harsh. Hi. Good afternoon, sir. My question is pretty broad, based on the U.S. industry. So after COVID, we had a couple of years of, not for the company, but overall at the industry level, we had some sort of headwinds in terms of price erosion and lower demand. So just wanted to get a macro view over next two, three years, what kind of environment are we seeing in terms of FDA approvals and the pricing of the base generic formulations? So I think on the approval side, FDA continues to deliver on good number of approvals. So I think fundamentally that's remained constant. I think also, I don't think the nature of business has changed in the U.S. It is a highly competitive, price-sensitive market, and so whether it was COVID or earlier or now, we don't see any fundamentally different ways of behaving in the market. I think what succeeds in the market is portfolio, your service levels, and how fast are you able to deliver your products, and what kind of service levels you are able to maintain with your customers. And strong focus on profitability helps you make the right decisions, I think. So fundamentally, all those things remain the same for that market, to whether it was in the past or for the future. In terms of demand scenario, do you feel anything is different for next two, three years compared to what it was there over after COVID, between 2021- 2023? In comparison, do you feel the demand scenario changing materially over the next two, three years? No, I think, at least when we look at our generics business, it all depends on large molecules going off patent. And as you can see, till the next five years, there are significant amount of products that will still go off patent. So the pipeline of future generic portfolio remains attractive. Sure. For the international business, the rest of the world business, so we see a lot of pharma companies now focusing on that pie of the market. So how does it sit in your overall strategy, and what kind of growth do you foresee over next, if I have to take a 3-5 years kind of an horizon? Yeah. So I think, for us, the international businesses have delivered a consistent double-digit CAGR over the last five years, and also have shown significant improvement in profitability. And, so we believe going forward, the business will definitely scale up meaningfully with strong double-digit growth, and also will continue on the improvement on profitability. So we are quite bullish on the international market, and that's why we said we will also continue to look at adding more products and geographies to expand it. Sure. Thank you. That was from my end. Thank you. Thank you. Thank you. The next question is from Sayan. Yeah, hi. Thanks for taking my question. Dr. Sharvil, I mean, your comments suggest that scaling up, you know, U.S. specialty is one of the things that you will be pursuing. I'm wondering if you can provide, you know, some aspiration that you carry with respect to the U.S. business, how you want to do this. We have, you know, mixed experience. It seems to be a tough one. I just want to understand what capabilities, you know, you would need to sort of develop to address that opportunity in a way that, you know And what kind of risk and size of acquisition that you're looking at? Because I would understand that it probably would require an acquisition for you to meaningfully scale up, U.S. specialty. So if you can give some color. I mean, we are aware of some of the products, you know, that you are developing, the rare disease, the liver disease. It would be great if you can, you know, give some clarity as to how you're thinking about this business and what are the steps we should expect. Sure. So I think there are two areas that we are focusing on, when it comes to the U.S. specialty side. One is the rare disease business, through our business unit of Sentynl Therapeutics. So today we have two commercialized products, one which we just recently acquired and one which we had done a few years ago, a year ago. And we have a third molecule, which is the CUTX-101, which is in the NDA stage of filing. So currently, it, it's a three asset business, and the way we look at it is that slowly build that business up over the next two years, mostly through small inorganic opportunities to scale that up and build a niche rare disease business. Now, in the rare disease business, the focus has to be, obviously, first is to have a product to market, because again, the disease is very rare. But then is to find new patients, which means a lot of work that needs to get done in education, in getting early diagnosis, and getting the right diagnosis and treatment, because these are life-saving drugs. So our effort is on creating a larger access for some of these drugs and finding the patients at the right time so that we can make them available. With respect to the orphan disease business that we hope to build, today, we have one asset, which is Saroglitazar. If everything goes well, it's a calendar year 2027 kind of opportunity to commercialize. I do agree that, our aspirations is to be in more than one product and not just a single product, though Saro on its own has a good business profile that we can build on. But we will look at, an inorganic opportunity over the next two years to have a commercially ready footprint in the U.S. when Saro comes up for launch. And that is what we hope to do in the next two years, is to find a commercial asset that we can, either partner or we could, acquire and build a front-end commercial asset in the U.S. which can also take Saro with it. Even if it doesn't, we do already have an organic plan to build our own commercial team in the U.S., but we will keep both options open for us, for the specialty side of it. I mean, the orphan side of it in the U.S. So these are the two areas we hope to build. We definitely don't want to be a one-product company. So Saro is very important right now, but we will hope to build onto it either through licensing or inorganic opportunity. And if you look at the timeline, obviously, 2027 is Saro, but our future molecules are 2030 and beyond. So we do, in the next five years, require some more options beyond just Saro. So that's what we will focus on. Great. The second question I had was on biosimilars. So you have done, you know, quite well in India, plus some emerging market approvals have also come through. But unlike many of the peers who have global development targeting U.S. and Europe, you have generally avoided that space. So why you are pursuing a different strategy here? And is there any change in thought process with, you know, evolving regulation or the competitive dynamics? Anything that you can share, given the capabilities that you've already built for India and emerging markets? Yes, I think we are quite aligned in terms of what we need to do for India and U.S. both in terms of the offerings that we can give, in terms of a large pipeline of biosimilars, and also the annual capacity that we have built for, which is quite large and a total monoclonal capacity of almost 350 KL. I think, you know, why we decided not to enter the developed markets were two reasons. One is, both from the investment point of view, the investments were pretty large and sizable for doing a generic version of a biologic. And the second was obviously access to the market, looking at the high rebates that exist in different markets. So I think we found it very difficult to justify the investment from our point of view. I think two reasons will make us think again about it. One is obviously, if the investment thesis comes down, which is when, if we can go towards more, a generic strategy, which is a PK, PK, PD strategy, then we can look at, you know, taking up some of the developed markets. And second, which we seem to think it is happening, is the interchangeability of biosimilars that may come to effect. So if both those triggers happen, we would look to take development for the developed markets also. But currently, we are limited on that aspect. And again, it's also to do with our allocation of asset allocation in terms of resources. We do have enough opportunities on the novel side, which is still higher risk, but obviously greater opportunity. So we are focusing our efforts more on that side. But as I said, if both of these changes do happen, we will potentially look to see if we want to take it up for the developed market. Yeah, great. Thanks. I'll join back. Thank you. The next question is from Kunal. Hi. Thank you for the opportunity again. So one on the product that is, that was approved today, Ingrezza. Is that a near-term opportunity that we should build on, either in FY 2025 or FY2026? No. It's more of a longer-term opportunity? Yeah. Okay. Okay. So we have settlement, I guess, right? And so it should be in line with that settlement, is a good way to put it? Yeah, it's definitely not a near-term opportunity, and as I said, we do have exclusivity and sole exclusivity as we have stated. So whenever that market formations happen, that will be the opportunity. Sure, sure. And, another one on the R&D expense. I'm not sure if this question was asked earlier, but we had said, it would be between 7%-8%. So do we maintain that guidance even in the, let's say, this year and the medium term? Yes, for FY2025, we maintain that guide. Sure. So, beyond FY2025, do you think that some of the trials may be for NASH, et cetera, it could be large clinical trials, and we might need to accelerate the R&D? So earlier, we had guided that our R&D year-on-year may range between 7%-9%, with average for 3 years around 8%. So we continue with that guidance even today. Sure, sir. Sure. Thank you, and all the best. Thank you, Kunal. We'll wait for attendees to raise their hand and ask questions. The next question is from Sayan Mukherjee. Yeah, hi, thanks. On sitagliptin and other approvals that you have, sitagliptin and combination approvals for the U.S., how are you thinking about it, based on the experience so far? I think you talked about possibly mid-high single-digit market share there. What are your latest expectations around that product? Yeah, so I think it's been a good learning for us, on trying to see how do we get a 505(b)(2) to market and successful. So I think what we can say comfortably is that, because of this opportunity and what we've been able to do, it's definitely not a 1-year opportunity, but at least a 3-5 year opportunity. So we will see consistent revenue, on this business from this franchise, which is very meaningful, and good for the organization and learning. So as I said, it's not a 1-year opportunity, but will continue for a longer period of time. The second is we continue to see how do we get more access to the overall gliptin franchise, and we hope to build more market share from what we have done today. We are seeing some good opportunities, so only time will tell whether if we can take up further opportunities for the coming year. But overall, it will be a meaningfully good product for us over the next 3-5 years. Right. So, will sitagliptin go generic before that? I mean, I'm just wondering, you know, whether you would have a window of five years to scale this up. It will go generic before, But we have a long-term contract, which will not get renewed till five years. Okay, okay. Understood. And the second one, I wanted to check on vaccines. I mean, it seems, you know, you talked about it, FY 2027-FY2028 timeframe. Any update on that, especially on the export side, you have you can share? Yeah. So I think we are on track for that period of time. There are three aspects that are important for our success. One is, pre-qualification of the facilities for the three vaccines. The second is the clinical, trial, you know, completion at different stages and for post-prequalification to make sure that we can achieve that, in that timeframe. And once we are able to achieve those two, then obviously is to participate in the public tenders that come up in 2027. So we are on track to do that, and no immediate hiccups, and at least on the PQ and other things, we are going on a positive direction now. Mm-hmm. So, sir, this is fiscal 2027 or calendar 2027 when the tenders come up? Ideally, it'll be more fiscal 28 calendar, but- Okay. - calendar 2027 to fiscal 2028, yeah. Understood. Okay. Okay. Okay, sir, thank you. Thank you, Sayan. Requesting attendees to raise their hand for further questions. Good. Good. The next question is from Kunal Dhamesha. Thank you, sir. So, one on the ALS, for which we are doing the clinical trial for ZYIL1, if you could provide some color on the, you know, disease landscape in terms of number of patients, potentially current treatment lines and, you know, where are we planning to differentiate? I think more detail, I would definitely request Arvind to give you specifically, but on broader side, today, there are no currently approved treatments for ALS. ALS is one of the classified orphan rare diseases that exist. So there is a sizable population of patients, both in India, if we look at it from a home market point of view, or obviously U.S. and other countries. So a highly unmet need exists for patients with ALS. As you know, the lifespan is only, meaningfully only two to three years or less, or around of that period, so it is a very debilitating disease. And as I said, with no currently class of treatment that is very effective, we see an a good opportunity for, you know, Usnoflast in this area. Our phase II trial recruitment is over, and if everything goes well, if we see good data and good blood-brain barrier penetration, this will move into a rapid phase IIb or phase III directly, from a global program point of view. So we are quite excited. I think the timeline for these trials would be shorter because of the need and the endpoints. So it looks good in terms of a speedy development timeline for this drug, if everything, if the, we are able to meet the critical endpoints and the safety margins that we are required to do so. And as I said, it is this therapy class has a broader opportunity in any motor neuron disorder. So ALS is our first target. We will continue to explore Parkinson's as the other indication, and then there are some other opportunities beyond that, but currently we are focused on these two indications. Sure, sir. And one on the Saroglitazar. I think we had got some FDA voucher of, I think fast track designation or orphan drug designation. If you could remind us, you know, what that is and how that helps us in terms of development timeline or the exclusivity. So we do have both those status. I think we don't have a voucher. Voucher you achieve when you get full approval, and then if you still maintain both of those things, then you do get a voucher. But so I think voucher is not something that we are building for right now. But we do get expedited review depending on the competition at that point in time and how many drugs are approved. So I think coming next calendar financial year, we can give you more update once we file the NDA to suggest whether we are still in... We are definitely in the orphan space, whether we are also in the fast track space or not. Sure, sir. And, any update on, you know, our recent, compliance, issues at Jarod facility? How are we planning to tackle it? Have we submitted more detailed CAPAs, or have we kind of onboarded some consultant, to resolve those, observations? Yeah, I think we're taking it very seriously to make sure that we address the concerns. So as a first step, we have obviously done the response to the FDA in terms of the remediation that we have done and continue to do. The second aspect is to request the FDA for a meeting to talk about our long-term plan with both, with these sites, which we hope to do over the next quarter. And post that, we can keep you more updated to see how do we tackle the observations at the site. But we are working very closely to do so, and we'll keep you updated if you have any more updates on that. Are there any compliance-related expenses, you know, already baked into our quarter one number? So right now, we don't have an external. We are not using any external faculty. So currently, we don't have any external expenses, but whatever has to be built in has already been built in in the quarter. Sure, sir. Thank you, and all the best. Thank you. The next question is from Nitin. Sir, thanks for taking my question. Now, Sharvilbhai, on the U.S. business, this year, obviously, because of with the Revlimid as well as Mirabegron playing out the way it is playing out, and next year, we still have a meaningful Revlimid tailwinds for us. Now, I mean, when you look at the U.S. business, say, of 2027 onwards, I mean, do we have enough drivers in the business to really grow on the top of the high base that we'll end up creating in 2025 and 2026? Yes, I think we do still have a good amount of pipeline of products to come through. Second, as I said, we do have some settlements which allow us sole exclusive launches in the years to come, which are meaningful. And so I think between the portfolio and exclusive launches, we, we do see an opportunity to continue to do well. And as I said, on the base business, we continue to grow, so we hope to continue to do that with the new launches. Thanks. And secondly, you know, in the past, you've talked a bit about your plans for two injectables and two transdermals. So, you know, if you can just give us a little more update on where we are on our complex injectable plans and on the transdermal launches. So I think it's transdermals. I think we are still a couple of years away from full scale up. So I think that business will continue to get built. On the injectables front, again, I think most of our drug device kind of products are, I mean, a few years out. So nothing in the medium term that we short term that we see. So, I mean, many of these are more a couple of years down the line plans. Transdermals is more nearer, but but, sorry, transdermal is more nearer, but injectables is still a couple of years out. Okay. Thank you. And secondly, on the India business, you know, we've had a pretty good growth in this quarter. I mean, and we have seen a meaningful pickup happening coming through in this business, an improvement in momentum over the last few quarters now, as you've been highlighting. I mean, over this period of time, has there been a proportionate or meaningful increase in that domestic business profitability also correlatively? Yes. I think, with the double-digit growth that we have delivered, we have seen also good improvement in profitability also. As I said, our sort of critical growth booster brands and key launches are now more than 45+% of our business and growing very fast. Once that business becomes 60%-65% of our overall growth driver, we will continue to see the strong momentum on growth. When you look at the next two years for the domestic business, what kind of market outperformance, you know, should we look forward to? I think we do expect to do better than market and register double-digit growth. Okay, sir. Okay. Thank you, sir. Thank you. The next question is from Alok. Hello? Alok, you can speak up. Hello, am I audible? Yes. Yeah. Okay. So, just a question which is pending on Asacol HD. Any update on that? Anything on the competition side? Yes, I think we still build for competition in this financial year. We were assuming there was some competition coming, but we haven't seen it yet. As per your intelligence, what is keeping the competition away? I think it's a difficult product to develop, so it's... We took quite a while to do it. I guess people are also struggling. Okay. For the U.S. for this year, how many new product launches are being planned? 25+. Okay. All right. That's it from my side. Thank you. Thank you. The next question is from Tushar. Am I audible? Yes. Sir, just, firstly, on generic Vascepa, how has been the scale-up in this product? Are we now to the run rate where we expect to be, or we are yet to reach that stable run rate? No, we are far away. We will require... I mean, right now, it's not at the run rate that we expected because of the capacities that we're not able to get from our partner. But, meaningfully, I don't think anything in this calendar year can happen. Understood. So is it the capacity constraint on account of, as in, the regulatory issue at the partner site, or the capacity buildup itself is going to take much longer? The capacity buildup. Pricing is very poor, so we don't want to do it at this pricing. Understood, sir. Understood. So secondly, just a clarification on EBITDA margin guidance of 28-29. We are already at, you know, 29%, but this quarter was heavy, both in terms of, let's say, Revlimid and Consumer Wellness, compared to, say, the four quarters of FY 25, and subsequently, it is going to be again the fourth quarter to be of such kind of phenomenon. So still, 28%-29% guidance. So if possible, to call out, you know, other niche products in FY 25, which can help sustain such kind of profitability. Apart from- Last year, as I said, we achieved 20, 27.5%, and we, our current guidelines, guidance, update for this year is about 100-150 basis points better than the FY 2024. Understood. And this is, considering, as the earlier participant was asking, this is considering Asacol HD competion. If that doesn't come through, we have a scope to further improve the margins. Yes. All right, sir. Thank you. Thank you. Thank you, Tushar. As there are no further questions from the participants, on behalf of Zydus Life Sciences Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines and exit the webinar.