Sunpharma Ltd — Q1 FY26

SUNPHARMA Q1 25/26 Earnings Conference Call https://stockanalysis.com/quote/nse/SUNPHARMA/transcripts/349403-q1-25-26/ Published: sourced from public earnings transcript

Operator Ladies and gentlemen, good day and welcome to Sun Pharma's Q1 FY 2026 Earnings Conference Call. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the call, please signal an operator by pressing star, then zero on your touch-tone phone. Please note that this conference is being recorded. I now hand the conference over to Dr. Abhishek Sharma, Vice President and Head of Investor Relations and Strategic Projects. Thank you, and over to you, sir. Abhishek Sharma VP and Head of Investor Relations and Strategic Projects, Sun Pharma Thank you. Good evening and a warm welcome to our first quarter FY 2026 earnings call. I'm Abhishek from the Sun Pharma investor relations team. We hope you have received the Q1 financials and the press release that was sent out earlier in the day. These are also available on our website. We have with us Mr. Dilip Shanghvi, Chairman and Managing Director, Mr. Kirti Ganorkar, CEO India Business and MD Designate, Mr. Aalok Shanghvi, Chief Operating Officer, Ms. Jayashree Satagopan, Chief Financial Officer, and Mr. Richard Ashcroft, CEO North America. Today, the team will provide an update on the financial performance and business highlights for the quarter, pipeline updates, and respond to any questions that you may have. Before we begin the call, I wanted to bring to everyone's attention that from this call, we have renamed Global Specialty as Innovative Medicines business. We will refer to the consolidated financials for the management committee. The call recording and call transcript will also be put up on our website shortly. The discussion today might include certain forward-looking statements, and these must be viewed in conjunction with the risks that our business faces. You are requested to ask two questions in the initial round. I also request all of you to kindly send in your questions that may remain unanswered today. I will now hand over the call to our CF O, Ms. Jayashree Satagopan. Jayashree Satagopan CFO, Sun Pharma Good evening. Welcome and thank you for joining in this earnings call after the announcement of the financial results for the first quarter of FY 2026. Our Q1 financials are already with you. Let me take you through the consolidated financial summary for the company. Sales for the first quarter of FY 2026 stood at INR 137,861 million, registering a growth of 10.1% over the last year. Gross margin was favorable, aided by lower material costs due to better product mix and a higher share of sales from the innovative medicines. EBITDA for the quarter was INR 43,017 million, recording a growth of 19.2% over the previous year. EBITDA margin percentage for the quarter was 31.1%. Profit before eceptional items and tax stood at INR 39,908 million, registering a year on year growth of 16.6%. During the quarter, exceptional items accounted for INR 8,180 million, primarily towards impairment of SCD- 044 and GxMDL settlement. Netting of the provisions in the books for part of the GxMDL settlement, the balance amount has been accounted during the quarter. Effective tax rate for the quarter was 24.3%, vis-à-vis 16.1% in Q1 FY 2025. Adjusted net profit for the quarter was INR 29,961 million, which is up by 5.7% from the corresponding period in the last year. Reported net profit for the quarter was INR 22,786 million after the exceptional items, compared to INR 28,356 million for Q1 of FY 2025. Forex gain during this quarter was INR 2,290 million, and this compares to a loss of INR 505 million during the same period last year. Other income during the quarter was INR 4,645 million, lower than last year, which included interest on income tax refund during the first quarter of FY 2025. Our balance sheet continues to be strong, with a net cash position of $3.1 billion at the consolidated level, which is invested in both approved securities and the remarks for future investments. Adjusted EPS for the quarter was at $12.50 per share. With this, I would like to hand it over to Kirti, who will share the performance of our India business. Kirti Ganorkar CEO India Business and MD Designate, Sun Pharma Thank you, Jayashree. I shall take you through the performance of our India business. For Q1, the sales of formulation in India were INR 47,211 million, recording a growth of 13.9% over Q1 last year. India formulation sales accounted for 13.2% of total consolidated sales for the quarter. Sun Pharma is ranked number one and holds 8.3% market share in over INR 2,302 billion Indian pharmaceutical market as per AIOCD Pharmarack MAT June 2025. Corresponding market share for the previous period was 8%. For the quarter ending June 2025, we grew higher than IPM, and we have done well across all major represented therapy areas. We are happy to note that, at a MAT basis, the sales growth has been led by volumes and new product launches versus the IPM growth, which is predominantly price-led. As per SMSRC Mar-June 2025 report, we continue to be the number one brand company based on the prescription volume. Sun Pharma is also ranked number one by prescription with 13 different doctor categories. For Q1 FY 2026, the company launched five new products in India. I will now hand over call to Rick for the update on the U.S. business. Richard Ashcroft CEO North America, Sun Pharma Thank you, Kirti. I'll provide an update on the performance of our U.S. business. Our overall U.S. business grew by 1.4% to $473 million for the quarter. This growth is driven by our innovative medicines portfolio, with all of our growth products contributing, including ILUMYA, Cequa, WINLEVI, and ODOMZO, but offset by a decline in our generics business due to additional competition in certain products. The U.S. accounted for 29.3% of consolidated sales for the quarter. In Q1, we launched four new generic products in the U.S. Earlier this month, Sun Pharma announced the launch of Leqselvi in the United States for the treatment of severe alopecia areata. This launch marks a major milestone towards strengthening our innovative medicines portfolio. Leqselvi represents a new and effective treatment option in the U.S. for severe alopecia areata, benefiting eligible patients, healthcare providers, and the broader healthcare system. We also announced Sun Pharma's has settled patent litigation with Incyte , result relating to Leqselvi, which removed the overhang of litigation from the product launch. I will now hand over the call to Mr. Shanghvi. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Thank you, Rick. I will provide an update on the performance highlights of our other businesses, as well as give you an update on our R&D initiatives. Our branded formulation revenues in emerging markets were INR 298 million, up by 5.1% over Q1 last year. The underlying growth in constant currency terms was 4%. Emerging markets accounted for 18.5% of total consolidated revenue for Q1. Amongst the larger markets in local currency terms, Romania, Russia, and South Africa have done well. Formulation revenues in the rest of the world were INR 219 million, up 15.5% over last quarter FY 2025. Rest of the world markets account for approximately 13.6% of consolidated revenue. In Q1 FY 2026, our global Innovative Medicine sales were up 16.9% to reach INR 311 million. We continue to invest in building an R&D pipeline for both the global generics and the Innovative Medicines businesses. Consolidated investments towards R&D for Q1 FY 2026 stand at INR 9,029 million, or 6.5% of sales. This includes a charge of INR 1,362 million on account of SCD- 044, which is reflected in exceptional items. Sun Pharma discontinued clinical trials of SCD- 044 and has no further plans for development of SCD- 044. Excluding the charge, R&D expenses for the quarter stood at INR 7,667 million, or 5.6% of sales. Innovative R&D accounted for 41% of our total R&D spend and stands at 11.8% of the global Innovative Medicine sales for the quarter after excluding exceptional charges. Moving on to updates on global Innovative Medicines, Sun Pharma's two phase III clinical studies evaluating ILUMYA in active psoriatic arthritis met their primary endpoint. These results support the potential regulatory submission of ILUMYA in the U.S. and in other markets. During the quarter, our partner Philogen decided to voluntarily withdraw the application for marketing authorization to the European Medicines Agency for Nidlegy. They plan to refile the application at an appropriate time when they have the requisite information. Sun Pharma has completed its acquisition of Checkpoint Therapeutics. The acquisition adds UNLOXCYT to Sun Pharma's innovative portfolio. UNLOXCYT is the first and the only FDA-approved PD-L1 treatment for advanced cutaneous squamous cell carcinoma. We are planning to launch UNLOXCYT in the U.S. in the second half of FY 2026. Abhishek Sharma VP and Head of Investor Relations and Strategic Projects, Sun Pharma That ends the readout. Operator, if we can, open the queue for Q&A. Operator Sure. Thank you very much. We will now begin the question- and- answer session. Anyone who wishes to ask questions may press star and one on their touchstone telephone. If you wish to remove yourself from the question queue, you may press star two. Participants are requested to use handsets while asking questions. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from Kunal Dhamesha from Macquarie. Please go ahead. Kunal Dhamesha Research Analyst, Macquarie Hi. Thank you for the opportunity and good evening. The first one on the ILUMYA successful trial on PSA, could you provide some timeline? I know it's at a filing stage, but how should we look at when the filing could happen and then when can we expect. What is the potential timeline here for the developed markets like U.S., Europe? Also, if you could provide some data points in terms of the proportion of patients reaching ACR 20, 50, or 70 at week 24, that would be great. Dilip Shanghvi Chairman and Managing Director, Sun Pharma The plan is to present the data or publish the trial result in a reputed journal before we start publicly talking about the data. I think the regulatory team is working with the CRO to ensure that as soon as we have all the requisite information, because we have currently only the top-line data, but once we have the requisite information for filing, the plan is to file. Hopefully, we should be able to file the product before the end of this calendar year. That's not something that I'm 100% sure about, but that's the plan. Kunal Dhamesha Research Analyst, Macquarie Sure. Thank you for that. The second question is regarding we had suggested that there would be incremental cost related to launch of Leqselvi and UNLOXCYT in FY 2026, which we had spec'd at around $100 million. Have we seen that impact in this quarter? Will it be more spread across the quarters, or will it be high at the time of launch and then come down from there on? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Sure. In addition to the actual cost outgo, there will also be amortization of the cost of the acquisition, and that will start only when the product is in market. We will see Leqselvi from this quarter. I think our estimation is that the overall cost of $ 100 million we will be sustaining during the year. You don't see that much in the first quarter, but it will start coming. Kunal Dhamesha Research Analyst, Macquarie Just a clarification. This $ 100 million includes both the cash and amortization charge, or it's just the spending and then amortization would be separate? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think it will be the direct cost, $ 100 million. Amortization will be separate. Jayashree Satagopan CFO, Sun Pharma The amortization will be factored in our guidance we created. Dilip Shanghvi Chairman and Managing Director, Sun Pharma We don't give profit guidance. Jayashree Satagopan CFO, Sun Pharma No, we don't give, but overall, we have told. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Okay. Yeah, okay. Kunal Dhamesha Research Analyst, Macquarie Sure. Thank you. I have more questions. I'll join back the queue. Operator Yes. Thank you. Thank you. Next question is from Neha Manpuria from Bank of America. Please go ahead. Neha Manpuria Senior Analyst, Bank of America Yeah. Thanks for taking my question. My first question is on Leqselvi. Now that we have launched the product, how should we look at, I mean, what would be the key milestones in terms of traction of the product? Because if you look at the other two competing products, we've seen very different trends in IQVIA in terms of the prescription trends. If you can just help us in terms of when you think we should get to a point where we are comfortable with formulary coverage, how much time would that take roughly? Dilip Shanghvi Chairman and Managing Director, Sun Pharma That's a very good question. Thank you for the response. Yeah. Richard Ashcroft CEO North America, Sun Pharma We just launched Leqselvi a couple of weeks ago. We're very encouraged by the early results. We've seen good receptivity with healthcare professionals and patients with our messaging. We already have patients that are going through our hub, which is our support program, and we already have our initial commercial prescriptions. We're in ongoing discussions with payers, which have been very positive. As I said, we're encouraged by what we've seen with the first two weeks in the market. Neha Manpuria Senior Analyst, Bank of America In your view, when do you think this starts converting into revenue contributions once you see that formulary coverage? Would it take, usually in your terms, nine months? Could it be a year out, or could you start seeing contribution much faster than that from a revenue ramp-up perspective? Richard Ashcroft CEO North America, Sun Pharma If we plan, we will see some impact yet this year, this fiscal year. Neha Manpuria Senior Analyst, Bank of America Understood. My second question is on the ROW market. That seems to have seen a very strong growth in the quarter. Is there anything, any milestones, anything in that number? What drove that strong growth in the ROW market? Richard Ashcroft CEO North America, Sun Pharma Could you repeat the question? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think she's asking about the rest of the world market. I think the overall, there's no specific event that I can point to. There may be some one-time sales which may also be responsible. The overall guidance that we have given includes the performance of the emerging market and the rest of the world market. Neha Manpuria Senior Analyst, Bank of America Understood. I'm sorry. If I could please ask one more question. On the MSN, based on your discussion, what is the sense of the likelihood of ILUMYA getting included in the demonstration project and therefore negotiations on that? Any color on that? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, maybe Rick, you can respond because I am away from the market that way. Richard Ashcroft CEO North America, Sun Pharma Yeah. I would say we have no further information on the MSN executive order. We have not had any dialogue with the government. We've not been contacted with respect to any products in our portfolio. Neha Manpuria Senior Analyst, Bank of America Understood. Thank you so much. Operator Thank you. Next question is from Damyanti Kerai from HSBC. Please go ahead. Damayanti Kerai Analyst, HSBC Hi. Good evening and thank you for the opportunity. My question is on the U.S. market. While we are still waiting for the official details to come on the tariff part, from your side, do you have any thought about improving your manufacturing footprint in the U.S.? Richard Ashcroft CEO North America, Sun Pharma Maybe I can start. We actually have a significant footprint in the U.S. already, and at this time, we have no plans to move further manufacturing to the U.S. Damayanti Kerai Analyst, HSBC If you can indicate, broadly, what percentage of sales come from your U.S. plant at this point of time, that will be helpful. Dilip Shanghvi Chairman and Managing Director, Sun Pharma That we don't disclose, Damyanti. Damayanti Kerai Analyst, HSBC Okay. You think the current capacity is good enough for you in case you need to onshore for manufacturing, and you have no immediate plan to add on there? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, I think that would be the right assumption. Damayanti Kerai Analyst, HSBC Okay. My second question is on the limited opportunity. Does one quarter number reflect meaningful contribution from that product? If you can also comment on the pricing for that product. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Rick, I'm sorry. Richard Ashcroft CEO North America, Sun Pharma I would say our generic business. Go ahead. I apologize. Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, no. Please, I wanted you to respond. Richard Ashcroft CEO North America, Sun Pharma I would say our generic business faces ups and downs quarterly due to lenalidomide. If we remove that impact, the U.S. generic business is down quarter- over- quarter and year- over- year. We did see continued pricing pressure for lenalidomide. Damayanti Kerai Analyst, HSBC Okay. Does 1Q have significant contribution from that product? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah. Yeah. Damyanti, Q1 lenalidomide sales were moderately higher versus Q4. Moderate. Damayanti Kerai Analyst, HSBC Okay, that's helpful. Moderately higher. Okay, thank you. That's helpful. I get back in the queue. Operator Sure. Thank you. Before we take the next question, a reminder to participants that you may press star and one to join the question queue. The next question is from Bino Pathiparampil from Elara Capital. Please go ahead. Bino Pathiparampil Head of Research, Elara Capital Hi. Good evening and good morning. A couple of questions. One, Dilip Bhai, were you happy about the top-line results from the ILUMYA psoriatic arthritis study, or could it have been better? I'm asking this because we have seen the ACR 20 numbers, which have come fine, but in ACR 50 and 70, maybe it didn't show much improvement. Dilip Shanghvi Chairman and Managing Director, Sun Pharma I think when you look at the numbers, you also need to look at the dosing. What we have is no induction dosing as well as only two injections. I think it's a very good result considering the dose and the overall safety profile. The doctors with whom we've discussed understand the product because it's a class that they are familiar with. We are comfortable with these numbers. Bino Pathiparampil Head of Research, Elara Capital Understood. Just a question on the one-off settlement that you have done. There was this $200 million settlement of Taro. From your footnotes, I understand that you have recognized only about $60 million in this quarter in Q1. Should we assume that the balance would be recognized in Q2, Q3, and Q4 as a separate item? Jayashree Satagopan CFO, Sun Pharma Let me take this question. Out of the $200 million, we were carrying a provision for part of it in our books from prior years. Netting off that, the balance has been fully accounted in this quarter, and therefore, we would not see any further exceptional item on this account in the forthcoming quarter. Bino Pathiparampil Head of Research, Elara Capital Got it. Thank you. I'll jump back to queue. Operator Thank you. Next question is from Shashank Krishnakumar from Emkay Global. Please go ahead. Shashank Krishnakumar Senior Research Analyst and Equity Research Pharma, Emkay Global Hi. Thanks for taking my question. My first question was on the domestic business. I think this quarter, we've seen a 14% growth on a relatively higher 1Q base. In the last few quarters, also, if I look at our growth rates, it's not a significant divergence, but a marginal divergence versus what secondary sales growth trends would indicate. I just wanted to understand if the OTC portfolio is now becoming a major part of our domestic piece, and probably there are a few sales channels which are not getting captured. Is it what is driving this marginal growth divergence versus what we've seen, secondary sales trends? Kirti Ganorkar CEO India Business and MD Designate, Sun Pharma No, no. The majority of the growth is coming from prescription business. It's not from a consumer business. Shashank Krishnakumar Senior Research Analyst and Equity Research Pharma, Emkay Global Okay. Got it. My second question was, last quarter, we had indicated that we are looking to launch a few new products in the diabetes and weight loss management space in the domestic market going forward. I just wanted to understand how this will sort of reshape the increment treatment regimens, particularly for diabetes. While the incremental opportunity size probably is being talked about, I just wanted to understand how the current standard of care treatments could get disrupted when some of these new launches come in starting next year. Dilip Shanghvi Chairman and Managing Director, Sun Pharma You're talking specifically of GLP-1s, or? Shashank Krishnakumar Senior Research Analyst and Equity Research Pharma, Emkay Global Yeah. Dilip Shanghvi Chairman and Managing Director, Sun Pharma GLP-1 effect on existing products. It's not going to be submitted. I think if you look at it that way, globally, there's a lot of experience about the impact of GLP-1 on sale of existing products, both DPP-4 as well as SGLT2. SGLT2, yeah. We haven't seen any significant degrowth in those. As a matter of fact, post-generics, I think there is an increase on it. I think if that is repeated in India, there should be no problem. Yeah. Shashank Krishnakumar Senior Research Analyst and Equity Research Pharma, Emkay Global Got it. Thank you. That's it for me. Operator Thank you. The next question is from Surya Narayan Patra from Philip Capital. Please go ahead. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Thank you for this opportunity, sir. In taking the GLP point further, could you give some sense about your participation in the first wave of commercialization of GLP-1 products in Canada and Brazil? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, I think maybe Aalok, you want to respond, but I don't know whether we share this information. Aalok Shanghvi COO, Sun Pharma I think Canada and Brazil, we have not shared the information, but what I can share is about in India, we will be in the first wave of launch. We are all working in that direction so that we come first to the market. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Sure, sir. Thank you. This is useful. Dilip, my second question was about the CAS deployment that you are having in the annual report that you have mentioned. In the recent past, much of the investment, what we have done, it is towards the specialty portfolio. This time you are also indicating about your interest beyond that. Could you give some clarity about that? What are the areas that you'll be interested in spending and all that? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think we've indicated that we'll continue to look for opportunities to strengthen our product portfolio in three therapy areas that we're interested in, ophthalmology, dermatology, and oncology. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Okay. Okay. Irrespective of the market? Dilip Shanghvi Chairman and Managing Director, Sun Pharma What is that? Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Irrespective of the market, not necessarily U.S. or India? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, I mean, generally, these assets, it's easier to do a global deal. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Okay. Sir, I was just looking at the China development also. We know that we have ILUMYA , ILUMETRI there through partner, but we have now created our own subsidiary also. If you can add some color to those kinds of development and interest. Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think it's an option that we are creating without any specific plan at this point. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Okay. Thank you. I have a couple more. I'll join in the queue. Operator Thank you. Next question is from Vishal Manchanda from Systematix. Please go ahead. Vishal Manchanda SVP Institutional Research, Systematix Thank you for the opportunity. Good evening, everyone. With respect to generic REVLIMID, we are almost halfway through into CY 2025, and there are quarters to go before the exclusivity expires. Is it fair to assume that you would have sold 50% of your allocated volume quota for the year? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, we don't give. Richard Ashcroft CEO North America, Sun Pharma We don't provide. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, Richard, continue. Richard Ashcroft CEO North America, Sun Pharma I was going to say we don't provide product-specific guidance. Vishal Manchanda SVP Institutional Research, Systematix Okay. Do we expect our U.S. formulation run rate to improve from here in the coming quarters? Richard Ashcroft CEO North America, Sun Pharma Again, we don't provide that level of guidance. Vishal Manchanda SVP Institutional Research, Systematix Okay. Just one more. I could see in your annual report that there is a sharp jump in the, with respect to India, there's a sharp jump in the neuropsychiatry therapy revenues on a YoY basis. A very sharp jump. Is this almost 1,000 crores, in fact, on a YoY basis? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, you're not correct. I think CNS growth is also in line with India growth. If I remember correctly, it is in the 11%- 12% range. Vishal Manchanda SVP Institutional Research, Systematix Okay. Just one final one on the tax rate. If you could give a number, what should be the tax rate this year? Jayashree Satagopan CFO, Sun Pharma For the full year, we can consider around 25%. Vishal Manchanda SVP Institutional Research, Systematix Got it. It should be there going forward, around 25%? Jayashree Satagopan CFO, Sun Pharma Yeah. Vishal Manchanda SVP Institutional Research, Systematix Thank you. Operator Thank you. The next question is from Vivek Agrawal from Citig roup. Please go ahead. Vivek Agrawal India Pharma Research, Citigroup Hi. Thanks for the opportunity. My first question is related to ODOMZO. Although it's a relatively smaller product in your global Innovative Medicines pipeline, the product was there in the market for quite some time. In the last couple of years, there is a sharp pickup, right? The product has got a decent market share against the competition average, right? What has changed? I just want to understand. Thank you. Richard Ashcroft CEO North America, Sun Pharma Yeah. At least in the U.S., I can comment, we continue to see nice growth of ODOMZO. It's really a recognition from clinicians of what the product can bring and also a strong execution from our sales and marketing teams. Vivek Agrawal India Pharma Research, Citigroup The product was there in the market, right, from around 2017, 2018, right, or 2018, 2019, right? In the last couple of years, is there any better coverage, or is it better sales force behind the product? Have you changed anything, right, that has resulted in a sharp pickup? Richard Ashcroft CEO North America, Sun Pharma I definitely think there's been improvement in execution with our sales team. I think also it's taken some time to convince loyalists to give the product a try. Once they give it a try, they stick with it. Vivek Agrawal India Pharma Research, Citigroup Understood. A related question with UNLOXCYT, right? Is it fair to assume that the channel as well as the prescribers are more or less the same for ODOMZO as well as UNLOXCYT? Richard Ashcroft CEO North America, Sun Pharma There is overlap. It's not 100% overlap, but there is overlap between the customers, which would be something we take advantage of from a sales and marketing perspective. Vivek Agrawal India Pharma Research, Citigroup Understood. Just one more question on Leqselvi, right? If you look at the competing molecules, let's say Olumiant, right, they have a restrictive coverage like prior authorization, limited quantity, etc. Even for Leqselvi, are you expecting similar kind of coverage, or will that be enough for the pickup in this product? Richard Ashcroft CEO North America, Sun Pharma Yeah. I think with all three products, we'll continue to see prior authorizations. Based on our ongoing negotiations, we do expect to have good coverage for Leqselvi versus the competition. Vivek Agrawal India Pharma Research, Citigroup Are you expecting a better coverage for Leqselvi against the competition? Richard Ashcroft CEO North America, Sun Pharma I think we're saying we expect at least parity coverage versus the competition. Vivek Agrawal India Pharma Research, Citigroup What is going to help you in, let's say, priority coverage over the competition? Richard Ashcroft CEO North America, Sun Pharma I think really the profile of the molecule. We know from message testing that both clinicians and patients really prefer what Leqselvi has to offer, particularly from a speed perspective. From the discussions with payers, they've been encouraged by the data we've shown them as well. Vivek Agrawal India Pharma Research, Citigroup Understood. Thanks, Richard. This is from my side. Richard Ashcroft CEO North America, Sun Pharma Thank you. Operator Thank you. Next question is from Kunal Dhamesha from Macquarie. Please go ahead. Kunal Dhamesha Research Analyst, Macquarie Hi. Thank you for the opportunity again. Just a logistic question. The small one-time kind of revenue that we are suggesting in ROW, is it part of Innovative Medicines business, or is it part of the non-innovative medicines business? Aalok Shanghvi COO, Sun Pharma It's a mix of both, Kunal. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Innovative Medicines business, we've given the details. What is the growth and the. Aalok Shanghvi COO, Sun Pharma Only about ROW. Only for ROW. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Understand, it is still included in the separate number that we've given for innovative business. Kunal Dhamesha Research Analyst, Macquarie Global innovative. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Global innovative. Kunal Dhamesha Research Analyst, Macquarie Just to clarify, the INR 311 million, does it include any milestone payment this quarter? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No. Kunal Dhamesha Research Analyst, Macquarie Okay. Sure. That's it. One question for Rick. Since now we have seen some bit of STELARA biosimilar launches in the U.S. market and Europe also, STELARA biosimilars have been there. Are you seeing any on-the-ground impact, maybe new-to-Rx patients? Given obviously biosimilar would be at a much lower cost compared to the medicines like ILUMYA or TREMFYA? Richard Ashcroft CEO North America, Sun Pharma Yeah. Not really. We have not seen any or any major biosimilar-first policies amongst payers. We also see more growth in the IL-23 class. There already has been movement away from STELARA in multiple therapy areas. Kunal Dhamesha Research Analyst, Macquarie Right. You don't expect also in the future that that could be the case, just for the new-to-Rx patient, not for the existing patient? Richard Ashcroft CEO North America, Sun Pharma Hard to predict the future, but we don't at this time based on our current discussions with payers and what we're seeing in the market. Kunal Dhamesha Research Analyst, Macquarie Sure. The last one on the UNLOXCYT launch, I think you suggested obviously it will be launched. Is it imminent? Should we expect the launch to be in this quarter, or what are we kind of waiting for? Is it preparations that we are doing? Richard Ashcroft CEO North America, Sun Pharma I can take this, Dilip, unless you want to? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, please go ahead. Richard Ashcroft CEO North America, Sun Pharma Yeah. Checkpoint has submitted long-term data for UNLOXCYT. We're currently waiting on that data to be approved and added to the label in the U.S. Once that occurs, we will launch. We are also planning for that launch and we're dealing with that currently. Kunal Dhamesha Research Analyst, Macquarie Sure. This long-term data, does it provide us with a clear differentiation versus the competing product? Is it in public domain? Richard Ashcroft CEO North America, Sun Pharma We believe it is very competitive, and it is in the public domain. Kunal Dhamesha Research Analyst, Macquarie Sure. Thank you and all the best. Richard Ashcroft CEO North America, Sun Pharma Thank you. Operator Thank you. Before we take the next question, a reminder to participants that you can press star and one to join the question queue. The next question is from Kunal Lakhan from CLSA. Please go ahead. Kunal Lakhan Senior Research Analyst, CLSA Yeah. Hi. Thanks for taking the question. Can you give some color on the whole observations and any timeline on when the final resolution there? Dilip Shanghvi Chairman and Managing Director, Sun Pharma We are engaging with the FDA on finding a resolution for Halol. We've responded to the 483, and we are waiting to hear back from the agency. Kunal Lakhan Senior Research Analyst, CLSA Okay. Any timeline you have in mind over which you would expect a full resolution of this plant? Kirti Ganorkar CEO India Business and MD Designate, Sun Pharma I mean, it would be speculative. We will need to wait for the agency to respond. Kunal Lakhan Senior Research Analyst, CLSA Sure. My second question was actually more of a clarification on the tariff announcement. Firstly, like our pharma company being exempted, or you'd be paying tariffs starting August 1st, or any tariff would be pending the outcome of 232 investigation. Any color on that? Dilip Shanghvi Chairman and Managing Director, Sun Pharma That is the understanding that it's post 232 investigation report. The government will decide on the next step. Til that time, I think pharma continue to be exempted from basic tariff. Kunal Lakhan Senior Research Analyst, CLSA Just a follow-up on that. From my understanding of what's happening with the E.U. deal is that they'll be paying 15% tariff, but it has a ceiling of that in respect of what the outcome of 232 investigation would be. Dilip Shanghvi Chairman and Managing Director, Sun Pharma I think my understanding is that E.U. deal also exempts pharma product. The pharma product don't carry 15%. Kunal Lakhan Senior Research Analyst, CLSA Sure. All right. Thank you so much. Operator Thank you. Next question is from Bino Pathiparampi l from Elara Capital. Please go ahead. Bino Pathiparampil Head of Research, Elara Capital Thanks for the follow-up. Actually, two follow-up questions. While answering an earlier question, you mentioned that India's growth is run by the prescription business. Now, if I look at the growth that's been pretty strong of late for several quarters. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, the voice is cracking, so it's good. Bino Pathiparampil Head of Research, Elara Capital Hello, is it better now? Jayashree Satagopan CFO, Sun Pharma Yeah. Bino Pathiparampil Head of Research, Elara Capital Hello? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, this is better. Operator Yes, much better. Please go ahead. Bino Pathiparampil Head of Research, Elara Capital Thank you. You replied to an earlier question that the India growth is run by the prescription business. It is very healthy now, much higher than the market growth rate. Is there anything that is driving this, like invoicing products, etc., which isn't there, or is it something which is sustainable? Once this comes into the base, would we go back to a market-plus growth rate, or is this sustainable? Aalok Shanghvi COO, Sun Pharma Yeah. I think what I can, because I cannot pinpoint to only one thing which is driving the growth, what I can say is it is a concentrated effort on brand building through scientific promotion and building deeper connects with the prescriber using science-led promotion, then improving the prescriber coverage. You also know we have done a full-force expansion in the past, and decluttered our portfolio and built selective presence in tier two, tier three towns. All of that, if we put together, I think this is helping us to grow better than the market. Bino Pathiparampil Head of Research, Elara Capital Okay. Got it. This tax rate, I think to an earlier question, 25%. As you said that your tax rate will gradually move up. Last year, we had about 16%, 17%. Are you saying that this year it's going to sharply jump to 25%? Jayashree Satagopan CFO, Sun Pharma The tax rates have been moving up quarter on quarter during last year, and currently, it is around 23.4%, and we expect for the full year to be around 25%. Bino Pathiparampil Head of Research, Elara Capital Got it. Thank you. Operator Thank you. Next question is from Tushar Manudhane from Motilal Oswal. Please go ahead. Tushar, we can barely hear you. If you could use the handset and speak a little louder, please. Tushar Manudhane Research Analyst, Motilal Oswal Is this better? Operator Yes, much better. Please go ahead. Tushar Manudhane Research Analyst, Motilal Oswal Maybe I'm mixed, but just if there's a revisit on the R&D cost as a percentage of sales for FY 2026? Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think we're staying with the guidance . Tushar Manudhane Research Analyst, Motilal Oswal Because this quarter, existing for the charge is $5.5 million. It implies that the R&D expense is going to be much higher in the coming quarters. Dilip Shanghvi Chairman and Managing Director, Sun Pharma Yeah, clinical start, I mean, we have three quarters to catch up. Tushar Manudhane Research Analyst, Motilal Oswal Sir, subsequently, further building on, let's say, adding the promotional marketing expenses of $100 million. If I have to think about the EBITDA margin, directionally, would this have sort of an impact on the EBITDA margin which we have done on 1Q FY 2026? I mean, asking you in terms of quantifying the number, but just as a direction, if you could explain. Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, I think the key difference between how you look at it and how we look at it is that we look at what is in the best interest of the business long term. Now, how that affects short-term EBITDA, I think we actually don't even calculate. I'm not able to respond, but our view is that both UNLOXCYT as well as Leqselvi have significant opportunity to strengthen our presence in the innovative product business and also strengthen our relationship with the customers. We will do whatever is required to become successful, and once we are successful, it pays for everything that we invest in. Tushar Manudhane Research Analyst, Motilal Oswal No, that's right. Dilip Shanghvi Chairman and Managing Director, Sun Pharma In the same way, I think trials also will have to be invested on, because then we'll create future revenue streams. Tushar Manudhane Research Analyst, Motilal Oswal Sir, the reference as far as R&D spend is concerned, if it has to be so high, then at least if it is possible to share the name of the product in the subsequent list of the R&D product in the pipeline, that would be helpful. Given that the existing table which has been highlighted in the press release, most of them are up for regulatory filing. Dilip Shanghvi Chairman and Managing Director, Sun Pharma GL0034 phase II will start. That also will add to the cost because those are larger studies. Tushar Manudhane Research Analyst, Motilal Oswal Got it. Sir, just one more on the, as far as the facilities being compliant for the U.S. market, if you could just share in terms of which all facilities have now, let's say, under issue while the business continues, but incremental generic approvals might be called, and which facilities are sort of compliant to get the approval. Aalok Shanghvi COO, Sun Pharma Yeah. Sure. We currently have three facilities that are under warning letters from the U.S. FDA, Mohali, Dadra, and Halol. We have other facilities in Baska, Ohm, Hungary, Haifa, Brampton, which continue to supply to the U.S. and do not have. We have one more facility in Billerica in the U.S., which is near Boston. All of these facilities continue to supply and are in a compliant status with the U.S. FDA. Tushar Manudhane Research Analyst, Motilal Oswal Got you. It is reasonable to assume that the ANDAs awaiting U.S. FDA approval would be a good number of ANDAs from those sites as well? Aalok Shanghvi COO, Sun Pharma The decision to file the product from the facility would be a function of the compliance status of the facility and the technology available at the facility. Tushar Manudhane Research Analyst, Motilal Oswal Right. No, I was referring to the 119 ANDAs which await U.S. FDA approval. Those ANDAs. Aalok Shanghvi COO, Sun Pharma That breakup we don't give, Tushar. Tushar Manudhane Research Analyst, Motilal Oswal Okay, that's it from us. Thank you. Aalok Shanghvi COO, Sun Pharma Thank you. Operator Thank you. Next question is from Neha Manpuria from Bank of America. Please go ahead. Neha Manpuria Senior Analyst, Bank of America Yeah, my question has been answered. Thank you so much. Operator Thank you. We take the next question. Next question is from Surya Narayan Badra from Philip Capital. Please go ahead. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Yeah, just one clarification. After settling this antitrust litigation, is it fair to believe that there is no more litigation relating to the antitrust that is there? Aalok Shanghvi COO, Sun Pharma They've given details. Dilip Shanghvi Chairman and Managing Director, Sun Pharma They have given details. Jayashree Satagopan CFO, Sun Pharma It is there, and we have given the details in the annual report. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Okay. Sorry for that. Second is about the ILUMYA for the new indication for the anti-carcinogenics. You mentioned that the filing is likely sometime this year, but what are the likely, I mean, how far the drug is from the commercialization in the U.S.? What could be the targeted market that can be addressed by this product? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Typically, there is an approval timeline for a new indication. Hopefully, we should achieve whenever that timeline is met post the filing. I think I don't know specific target for psoriatic arthritis, but broadly, what I understand is that around 30% of the psoriasis patients also suffer from psoriatic arthritis. That market then becomes available to us. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Okay. About the kind of formulary additions of this molecule, since there is already one molecule there in the market, should the timeline required for putting this new drug in the various formularies be less critical and take less time, or how should one think about it? Dilip Shanghvi Chairman and Managing Director, Sun Pharma Rick, maybe specific. Richard Ashcroft CEO North America, Sun Pharma Happy to. Is this question specifically related to ILUMYA? Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Yeah, for the new indication, psoriatic arthritis. Richard Ashcroft CEO North America, Sun Pharma Got it. We would expect to have similar access to what we have today for psoriasis. It would likely fall under the same contractual arrangement. Surya Narayan Patra SVP of Healthcare and Specialty Chemical Research, PhillipCapital Sure. Thank you. Richard Ashcroft CEO North America, Sun Pharma Thank you. Operator Thank you. Next question is from Yogesh Soni from InCred. Please go ahead. Yogesh Soni Equity Research Associate, InCred Thanks for the opportunity, sir. One quick question. I wanted to understand the amount for which we have settled inside the litigation, one-time amount that we have given, and whether that would be part of exceptional items in second quarte r? Jayashree Satagopan CFO, Sun Pharma We don't give indications on this. Dilip Shanghvi Chairman and Managing Director, Sun Pharma The terms are confidential. Yogesh Soni Equity Research Associate, InCred Okay. Another question that I have is, I wanted to understand the UNLOXCYT launch timeline, whether it would be towards the start of the second half or later part of the year? Richard Ashcroft CEO North America, Sun Pharma We expect to launch in the second half of the fiscal year. Yogesh Soni Equity Research Associate, InCred Okay. Got it. Thank you. Richard Ashcroft CEO North America, Sun Pharma Thank you. Operator Thank you. The next question is from Vivek Agarwal from Citig roup. Please go ahead. Vivek Agrawal India Pharma Research, Citigroup Yeah, thanks for the opportunity again. Just one clarification, I thought. For the U.S. generic business, you indicated that it is down YoY as well as quarter on quarter in this quarter. Is that right? Richard Ashcroft CEO North America, Sun Pharma That is correct. Vivek Agrawal India Pharma Research, Citigroup Okay. Thanks. Just a related question. Previously, you commented that clearance of Halol facility is going to be very important for the U.S. generic business. Now, Halol clearance doesn't look like in sight, at least this particular year. How should we look at the generic business this particular year or the year after that? Are you expecting growth in the business from launches from the other facilities, or is it going to decline YoY? Thank you. Richard Ashcroft CEO North America, Sun Pharma Yeah. I don't think we provide that forward-looking guidance, but as Aalok mentioned, we obviously have other sites in which we're able to supply the U.S. market, and we have an existing portfolio that we can look to grow to offset any headwinds we face for our new products. Vivek Agrawal India Pharma Research, Citigroup Thanks. That's all I had. Operator Thank you. Next question is from Anubhav Agarwal from UBS Securities. Please go ahead. Anubhav Agarwal Executive Director, CAO, and Operating Officer India, UBS Thank you. Just one clarity on the tax rate. This 25% number, does it include the deferred tax component? How much is this deferred tax component? Just trying to understand, is it cash tax rate for the company also 25%? Jayashree Satagopan CFO, Sun Pharma We have to look at it all-inclusive on a yearly basis, which will be at 25%. The cash outgo may be lower because of some MAT credits that are still available with us. Anubhav Agarwal Executive Director, CAO, and Operating Officer India, UBS I'm just trying to understand, is that difference dramatically? I mean, just taking a case, right? The effective tax rate could be 25%, but the actual cash outflow may be 20%. Is that the case? Jayashree Satagopan CFO, Sun Pharma Yeah, there will be a difference, but we don't share the exact details. Anubhav Agarwal Executive Director, CAO, and Operating Officer India, UBS Okay, thank you. Operator Thank you. Next question is from Kunal Dhamesha from Macquarie. Please go ahead. Kunal Dhamesha Research Analyst, Macquarie Hi. Just one clarification from Rick. On the question related to the formulary access for ILUMYA for PSA indication, did you mean that from day one of launch, we'll have similar access to what we have currently for ILUMYA, or whatever that date may be, whatever ILUMYA would have coverage? Is that the correct understanding? Richard Ashcroft CEO North America, Sun Pharma That is the correct understanding. Kunal Dhamesha Research Analyst, Macquarie Is it also fair to kind of assume that the ramp-up could be much faster here? Richard Ashcroft CEO North America, Sun Pharma We should have fewer free goods than we typically would have with a new launch. Yes. Kunal Dhamesha Research Analyst, Macquarie Sure. While there is a second question, while there is an overall number of 30% of psoriasis patients having psoriatic arthritis, is there any age-related increase or decrease in incidence that we have seen in the data in terms of prevalence data that maybe aged individuals do have a higher 50% prevalence maybe? Richard Ashcroft CEO North America, Sun Pharma You know, that's something we'll have to follow up on. I'm not aware if there is an age-related change that happens with psoriatic arthritis. Certainly, as patients have psoriasis longer, they're more likely to have psoriatic arthritis. I'm not sure if there's a major difference between an older population and a younger population. We'll have to follow up. Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, Rick, you're right. There is no age tradition between the onset of psoriatic arthritis and psoriasis. Kunal Dhamesha Research Analyst, Macquarie Sure. Thank you. Thank you. Operator Thank you. Next question is from Madhav from Fidelity. Please go ahead. Madhav Marda Investment Analyst, Fidelity Safiya, just wanted to check. We plan to file for the PSA indication by end of this calendar year. Typically, what's the approval timeline? Is it about 12 months? Is that the right way to think about it? Richard Ashcroft CEO North America, Sun Pharma Yes. Madhav Marda Investment Analyst, Fidelity Okay, thank you. Dilip Shanghvi Chairman and Managing Director, Sun Pharma 10 months. Richard Ashcroft CEO North America, Sun Pharma Yeah, it's in the 12 months. Operator Thank you. The next question is from Aditya from Digital Beast Securities. Please go ahead. Thank you for taking my question and good evening, good morning to all of you. This quarter, we have done a guide at about 31.1%. What is our guidance for the full year? Jayashree Satagopan CFO, Sun Pharma We normally do not give a margin guidance. Dilip Shanghvi Chairman and Managing Director, Sun Pharma No, margin, we don't. Okay. If I can ask, what led to a margin of 31.1%? Is it your lower cost of raw materials, or have there been some other cost-saving measures which you have taken that has led to a margin of 31.1%? Jayashree Satagopan CFO, Sun Pharma Yeah. There has been a mix of factors, as I was mentioning earlier. There is an improvement in the raw material cost. It is also the product mix, which has been quite helpful. We've seen a higher specialty sales and also the branded formulation business. Okay, thank you very much. Operator Thank you very much. We'll take that as the last question. I would now like to hand the conference over to Dr. Abhishek Sharma for closing comments. Abhishek Sharma VP and Head of Investor Relations and Strategic Projects, Sun Pharma Thanks, everyone, for joining us at this late hour. If you have any questions which have remained unanswered today, you can reach out to the investor relations team. Wish you all a very good evening. Thank you and over from us. Operator Thank you very much. On behalf of Sun Pharma , that concludes the conference. Thank you for joining us, ladies and gentlemen. You may now disconnect your lines. Powered by