Sun Pharmaceutical Industries Limited (NSE:SUNPHARMA)
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Apr 24, 2026, 3:30 PM IST
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Q3 25/26

Jan 31, 2026

Operator

Ladies and gentlemen, good day, and welcome to Sun Pharma's Q3 FY 2026 financial results 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 touchtone phone. I now hand the conference over to Dr. Abhishek Sharma, Vice President and Head of Investor Relations and Strategic Projects, for his opening remarks. Thank you, and over to you, sir.

Abhishek Sharma
VP and Head of Investor Relations, Sun Pharma

Thank you. Good evening, and a warm welcome to our third quarter FY 2026 earnings call. I welcome you all, especially, to have joined us on a Saturday. I'm Abhishek from the Sun Pharma Investor Relations team. We hope you have received the Q3 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, Mr. Kirti Ganorkar, Managing Director, Mr. Alok Shanghvi, Chief Operating Officer, Ms. Jayashri Satagopan, CFO, and Mr. Richard Ashcroft, CEO, North America. Today, the team will provide an update on financial performance and business highlights for the quarter, pipeline updates, and respond to any questions that you may have. We will refer to the consolidated financials for management comments.

The call recording and call transcript will also be put up on our website shortly. Just to add, in recent weeks, there has been speculation in media regarding Sun's M&A interest in certain companies. We have clarified to exchanges that the news is speculative in nature, and we will not be taking any questions in today's call regarding the news articles and their subject. 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 CFO, Ms. Jayashri Satagopan.

Jayashree Satagopan
Group CFO, Sun Pharma

Good evening, all. Welcome, and thank you for joining us for this earnings call after the announcement of financial results for the third quarter of FY 2026. Our Q3 financials are already with you. As you said, we will look at key consolidated financials of the company. During the third quarter of FY 2026, we recorded sales of INR 154,691 million, registering a growth of 15.1% vis-à-vis Q3 FY 2025. Besides the underlying business growth, we also had a milestone income of $55 million in Rest of the World in the third quarter. Ex-milestone, overall sales growth was 14.7%. In the corresponding quarter of FY 2025, Sun had received a milestone payment of $45 million.

Gross margin during the quarter was at 81%, higher than the same period last year, largely on account of better product mix. EBITDA for the quarter was INR 49,485 million, an increase of 23.4% over Q3 last year. EBITDA margins came in at 31.9%, higher both on a year-on-year and a quarter-on-quarter basis. Excluding the impact of milestone income, favorable Forex impact, and other operating revenues, the EBITDA margins for the company improved mostly on account of better product mix. During the quarter, an exceptional charge of INR 4,895 million was taken primarily on account of Wage Code gratuity as per ICAI guidelines and additional provision for Gx MDL final settlement.

Reported net profit after tax for Q3 FY 2026 was INR 33,688 million, up by 16% over Q3 last year. Adjusted net profit for the quarter was INR 35,367 million, up 9.9%. EPS for the quarter was INR 14 per share. Effective tax rate for the quarter was 24.3%, vis-à-vis 14.7% in the third quarter of FY 2025 and 24.7% in Q2 FY 2026. Forex gain during the quarter was INR 1,539 million. Our balance sheet continues to be strong, with a net cash of $3.2 billion at the consolidated level. Now, we will discuss the nine months' performance.

For the first nine months of FY 2026, sales was at INR 436,604 million, registering a growth of 11.3%. Gross margin was at 80% for the first nine months. EBITDA came in at INR 137,772 million, registering a growth of 19.2%, with a resulting EBITDA margin of 31.4%. Adjusted net profit for the nine months was INR 96,508 million, up by 6.1%. The board has declared an interim dividend of INR 11 per share for the year FY 2026, against INR 10.5 per share interim dividend for the previous year. I will now hand over the call to Kirti, who will share the performance of our global innovative medicines business and the India business.

Kirti Ganorkar
Managing Director, Sun Pharma

Thank you, Jayashri. I shall first provide you an update on global innovative medicine business. In Q3 of FY 2026, our global innovative medicine sales were up 14.3% to reach $423 million. Ex milestone income, our global innovative medicine growth came in at 13.2%. An additional point on the milestone income, while Sun has had a milestone income in the last year, it may or may not recur in the future. Hence, you may treat it as one-off income. Our performance in innovative medicine business continues to be driven by a mix of growth in US and ex-US markets. Recently, we launched Enloxit in the US. During the quarter gone by, we have also introduced Ilumya in India. Early feedback for both the launches has been quite encouraging.

Coming to India business, for Q3, sales of formulation in India were INR 49,986 million, recording a growth of 16.2% over Q3 last year. India formulation sales accounted for 32.3% of total consolidated sales for the quarter. Sun Pharma is ranked number one and holds 8.4% market share in the over 2,407 billion Indian pharmaceutical market, as per Pharmarack MAT, December 2025. Corresponding market share for the previous period was 8.1%. For the quarter ending December 2025, we grew higher than the IPM, and we have done well across all major represented therapy areas. The sales growth continues to be led by higher contribution from volume and new product introduction as compared to the overall market.

Our volume growth of 6.3% for the quarter beat IPM volume growth, which is at 1.2%. As per SMSRC, July-October 2025 report, we continue to be the number one brand based on the prescription volumes. Sun Pharma is also ranked number one by prescription with 14 different doctor categories. For Q3 of FY 2026, the company launched 12 new products in India. As the leaders in diabetes and metabolic segment, we are looking forward to expand our portfolio with the launch of semaglutide upon the expiry of semaglutide patents in India. Sun's plans to be in the market on day one of a generic launch. We have already received the regulator's approval for both the indication of chronic weight management as well as treatment of type 2 diabetes under the brand name NovelTreat and SemaTrinity, respectively.

We are well positioned here with an expected launch across both indications, as well as all the strength, presenting a comprehensive solution to the physicians as well as patients. Our brands will be made available in easy-to-use format, and we have ensured sufficient supplies to meet the demand in India. I will now hand over the call to Rick for the update on the U.S.

Rick Ashcroft
CEO of North America, Sun Pharma

Thank you, Kirti, and good evening. Let me share the performance highlights of our US business. Our overall US business was marginally up by 0.6% to reach $477 million for the quarter. Growth in innovative medicines was offset by lower sales in the generic business due to additional competition in certain products. The US accounted for 27.5% of consolidated sales for the quarter. For Q3, we launched three new generic products in the US. As Kirti mentioned, recently, we've also launched Enloxit in the US for the treatment of advanced cutaneous squamous cell carcinoma. Our early launch efforts have been focused on education and awareness of healthcare professionals. We are also in active discussions with health systems to ensure wide access for the product. Our initial interactions have been positive.

We have completed initial stocking and had our first orders from distributors. I'd also like to give a quick word on Leqselvi. The initial response from physicians has been encouraging. Physicians are reporting early signs of hair regrowth in patients, which mirrors our clinical data, including in some patients who have previously failed other JAK inhibitors. I will now hand over the call to Alok for updates on our other businesses. Alok?

Alok Shanghvi
COO, Sun Pharma

Thank you, Rick, and good evening to everybody on the call. I will provide an update on the performance highlights of our other businesses. Our formulations revenues in emerging markets were $337 million, up by 21.6% over Q3 last year. The underlying growth in constant currency terms was 13%. In emerging markets, we have seen broad-based growth in the generic and innovative medicine business. Emerging markets accounted for 19.4% of total consolidated revenue for Q3. Among the larger markets, Romania, South Africa, and Brazil have done well in local currency terms. Formulation revenues in Rest of the World were $296 million, up 14.5% over Q3 FY25. We have seen growth both in the generic and innovative medicine business in ROW.

The Rest of the World markets accounted for approximately 17.1% of consolidated revenue. I will now hand over to Mr. Dilip Shanghvi for updates on R&D.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah. Thank you, Alok. Let me take you through our R&D initiatives and activities. We continue to invest in building a R&D pipeline for both the global generics and the innovative medicine business. Consolidated investments made towards R&D for Q3 FY2026 stand at INR 8,928 million or 5.8% of sales. Innovative R&D accounted for 30.5% of our total R&D spend, and stands at 7.2% of global innovative medicine sales for the quarter. During the quarter, we filed sBLA for Ilumya with the U.S. FDA in the indication of psoriatic arthritis. FDA approved label updates on Enloxit, based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma. We've also initiated global phase 2 trials of GL0034 in the indication of type 2 diabetes.

FDA has also updated Ilumya label recently with additional efficacy data in treatment of psoriasis of the nail.

Abhishek Sharma
VP and Head of Investor Relations, Sun Pharma

Operator, we can open 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 the touchtone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking questions. Ladies and gentlemen, we will wait for a moment while the question queue assembles. To ask questions, please press star and one. First question is from Rishi Parekh, from J.P. Morgan. Please go ahead.

Rishi Parekh
Executive Director and Senior Analyst for India Healthcare and Pharmaceuticals, JPMorgan

Good morning, and good evening, I guess. Thank you so much for taking my question. Now, I appreciate you're not taking questions on what's speculative out there, but for many of us that are new to Sun Pharma, I was just hoping that you could walk us through your M&A strategy and what you're hoping to target or achieve with the strategy. Are you looking at tuck-ins? Are you looking to add biosimilars? Are you looking to expand your geographic presence? And how important is North America in this strategy?

Dilip Shanghvi
Executive Chairman, Sun Pharma

I think almost for all of those issues, we've indicated responses to analysts on this call in the past. I think US continues to be an important part of our focus, specifically for the innovative medicines. And not only US, but we have interest in selling innovative medicines globally. For emerging markets, we are looking at what you call tuck-ins or smaller acquisitions, which we can look at integrating with our existing business to gain scale in the emerging markets. And we have also consistently indicated that we want to remain disciplined about acquisition. Our focus is on finding a way to grow our business organically at a rate, so that we continue to be an attractive investment opportunity for shareholders.

We would look at an acquisition only if we think that it can help us in terms of strengthening our long-term strategic capability.

Rishi Parekh
Executive Director and Senior Analyst for India Healthcare and Pharmaceuticals, JPMorgan

Can you also talk us through the size of the types of acquisitions you're looking at?

Dilip Shanghvi
Executive Chairman, Sun Pharma

So I.

Rishi Parekh
Executive Director and Senior Analyst for India Healthcare and Pharmaceuticals, JPMorgan

That you would do.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Unless and until. So I, I think we've indicated in the past that we need to be confident that whatever acquisition we make, we should be able to manage effectively without our diluting focus on our own growth. At the same point of time, I think we've also indicated that for acquisition, if it is necessary, we are comfortable raising debt.

Rishi Parekh
Executive Director and Senior Analyst for India Healthcare and Pharmaceuticals, JPMorgan

Thank you. Thank you.

Operator

Thank you. The next question is from Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Thanks for the opportunity. Sir, on the innovative medicine sales, ex of milestone payment, the growth has been bit soft compared to earlier quarters. If you could, you know, elaborate on that? That's my first question.

Kirti Ganorkar
Managing Director, Sun Pharma

Yeah, I will answer your question. As we have called out in Q3 FY 20, certain one-time sales to our partner, and that has given Q3 25 high base, and that is one reason for the growth looking lower in H1. Our specialty should continue to do well. It is difficult for us to comment quarter-to-quarter. My view is always you look at the business on annualized basis, rather than looking at quarter-to-quarter basis.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Okay. And so secondly, R&D spend on the innovative portfolio is both as a percentage of total R&D, as well as absolute amount, has been reducing for past two, three quarters. If you could also explain that?

Dilip Shanghvi
Executive Chairman, Sun Pharma

So I think it's all linked with commencing clinical trials. As we are commencing new clinical trial, including the one for GL0034, we should some increase in the R&D spend. And next quarter, we will guide our R&D next year. That will be for our expected R&D spend for next year.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Got it, sir. Just lastly, if I may, US sales, ex of Revlimid, has the portfolio grown or it has still been stable? If you could just throw some light on that.

Rick Ashcroft
CEO of North America, Sun Pharma

Is the question specifically related to generics?

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Yes.

Rick Ashcroft
CEO of North America, Sun Pharma

Excluding lenalidomide, the generics business is slightly down in the US.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

So is this to do with price erosion or lack of launches? If you could also explain that.

Rick Ashcroft
CEO of North America, Sun Pharma

It's really due to specific competition for certain products.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

How do you see this improving going forward?

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I think overall for the U.S., we see the innovative medicines continuing to grow, and the generic business will start to recover once we are in manufacturing compliance at a number of our sites in order to launch new products.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Got it. Very clear answer. Thanks a lot.

Operator

Thank you. The next question is from Damayanti Kerai from HSBC. Please go ahead.

Damayanti Kerai
Senior Equity Analyst, HSBC

Hi, good evening, and thank you for the opportunity. My first question is on gross margin. Just want to understand it better. In your opening remarks, you mentioned, better mix led to, such strong gross margin. So if you can just explain, like, what are the key, drivers to sustain such high, gross margin? As we understand now, Revlimid benefit is over, for you. So if, some additional color to explain the very strong gross margin performance.

Jayashree Satagopan
Group CFO, Sun Pharma

Thanks for your question, Damayanti. As you know, we don't specifically guide on product margins. Having said that, better mix of products, both in terms of, branded products and, our innovative medicines, has given an uptick compared to the gross margin in the previous, year.

Damayanti Kerai
Senior Equity Analyst, HSBC

Okay, and you think this level of margins will sustain, or how do you see margins trending ahead?

Jayashree Satagopan
Group CFO, Sun Pharma

As I was just mentioning, we normally do not guide on margins. Our endeavor is to see how we sustain, and we perform to our potential.

Damayanti Kerai
Senior Equity Analyst, HSBC

Okay, sure. My second question is on spend on the new launches, where you indicated incremental spend of $100 million or so. So, in terms of spend, where do you, you know, how much of that is already covered and how much is yet to come? And where are the major spend happening?

Kirti Ganorkar
Managing Director, Sun Pharma

Rick, maybe you can explain.

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I can address. Yeah, I'm happy to address that. So the spend is really occurring on the Leqselvi and Enloxit launches. It was fairly evenly split. We do see that spend increasing now in the latter part of the fiscal year, particularly as we've just launched Enloxit. We do expect this to be kind of part of our core expenses, though, going forward.

Damayanti Kerai
Senior Equity Analyst, HSBC

Okay. So, next year as well, we see, we expect elevated spend on these new launches as you build up, the market reach, et cetera?

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah. Next year, it'll just be part of our core operating OpEx to support these and the rest of our innovative medicines business.

Damayanti Kerai
Senior Equity Analyst, HSBC

Okay. With Enloxit very recent launch, but any color on how you're proceeding with your discussion with the insurance partners, et cetera, and when do you expect those deals to sign, like when you have the healthcare partners onboarded?

Rick Ashcroft
CEO of North America, Sun Pharma

Is the question related to Enloxit?

Damayanti Kerai
Senior Equity Analyst, HSBC

Yes.

Rick Ashcroft
CEO of North America, Sun Pharma

Sure. So we're having active discussions with physicians, as you would expect, given we're just a few weeks outside of launch. From a distribution perspective, the distribution network is in place. As I had shared, those agreements are in place. The product has been stocked, as well as the agreements with downstream customers. The other important discussions are with health systems. As this is an oncology product, a lot of the prescriptions will come from health systems. So we have been in active discussions with health systems since before launch. We have been in touch with the top 50 cancer centers within the U.S., and all of those discussions have been progressing positively. So for the first few weeks, very pleased with what we've seen so far.

The message is resonating in terms of the balance, that this product provides in terms of efficacy and safety. It's something that clinicians have been looking for. And again, within the health systems, the discussions from a formulary perspective have been progressing positively.

Damayanti Kerai
Senior Equity Analyst, HSBC

Sure. Thank you. I'll get back in the queue.

Rick Ashcroft
CEO of North America, Sun Pharma

Thank you.

Operator

Thank you. The next question is from Neha Manpuria from Bank of America. Please go ahead.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

Yeah, thanks for taking my question. My first question is on the India business. Given the strong performance that we have seen and the upcoming launch of Sema that you indicated, should we expect this growth rate to improve further as we look, you know, through the next few quarters, particularly as we add Sema? And just a related question on that, would we need to add any more sales force or any plans to expand the sales force, sales force in India, generally with, for Sema or otherwise, given the strong growth that we've seen?

Kirti Ganorkar
Managing Director, Sun Pharma

Yes. I think, Neha, you'll appreciate that it's very difficult for us to predict what will be the future growth and how we will grow, so we will not comment on that. Coming to your question on GLP-1, yeah, we will add some few field force for the launch of the product, and that's like the way we do the business in India. Yeah.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

This hasn't been done as yet, sir?

Kirti Ganorkar
Managing Director, Sun Pharma

Yeah, yeah, we are preparing for the launch, as I said in my readout, so some of this thing has already been done.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

All right. Okay, got it. My second question is on the R&D spend for generics. If I were to strip out the specialty number that you mentioned, that seemed to have, you know, increased quite a bit. So if you could give us some color, you know, in terms of incrementally, you know, where are we looking at spends? You know, and since historically, we have kept biosimilars outside, you know, any plans in sort of looking at biosimilars again with the change, given the change in regulation?

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah, I did not understand. What is the question?

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

If I look at the gen, you know, ex, specialty R&D spend, right? Then after stripping out the R&D, specialty R&D that you give, the generic spend seems to have increased quite a bit. So, you know, could you give us some color on where we are spending on generics specifically, and also our thoughts on, you know, biosimilars? How should we look at that opportunity for Sun Pharma, particularly given we haven't done too much in the past?

Dilip Shanghvi
Executive Chairman, Sun Pharma

So, no, I think we are giving some split between the generic and the specialty, but beyond that, within generic, where we spend the money, is not something that we give at a granular level. We also recognize that, we're not only talking to constituents, investors, but we're also talking potentially to competitors. So generally, we avoid sharing commercially sensitive information on this call.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

Understood. And on biosimilars, has your view there changed in terms of looking at that opportunity overall?

Dilip Shanghvi
Executive Chairman, Sun Pharma

So we—I think last time also I indicated, so we are evaluating, re-looking at, because we have to look at comprehensively, including setting up manufacturing, investment, overall cost of development, and the time for the investment to produce any kind of meaningful return. So, so we are evaluating everything to take a decision.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

Understood. Sorry, promise, even one last question on Enloxit. You know, how are we thinking about positioning this product versus, you know, our peers? Would it be the warehousing patients that we would look at first or the new patients that come in?

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah, Rick, maybe you can respond.

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I think the position of Enloxit in the market is very clear and very crisp. What it really offers is balance between efficacy and tolerability. So Enloxit works three ways: It restores adaptive immunity, which is by binding to the PD-L1. It engages the innate immune system based on its active Fc domain that activates natural killer cells, and unlike the existing products, it preserves PD-L2 signaling. And the reason that's important is that's the pathway through which immune-mediated adverse events are typically anticipated.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

Mm-hmm.

Rick Ashcroft
CEO of North America, Sun Pharma

So that, that's really the positioning of Enloxit in the marketplace, and as I said, that, that's been resonating with, with clinicians.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

And if you think, you know, this would be more importantly getting new patients on board, or could we initially go after the patients that have used existing products and haven't worked for them?

Rick Ashcroft
CEO of North America, Sun Pharma

We would mostly anticipate new patients.

Neha Manpuria
Director and Lead Analyst for India Healthcare, Bank of America

Okay. Thank you so much.

Operator

Thank you. Next question is from Binu Pathiparampil, from Elara Capital. Please go ahead.

Binu Pathiparampil
Head of Equity Research of Pharmaceuticals, Elara Capital

Hi, good evening and good morning. The first question is sort of a follow-up from earlier questions. Just wanted to know if there is any lenalidomide contribution at all in Q3, or was it completely over in Q2?

Rick Ashcroft
CEO of North America, Sun Pharma

Quite small in Q3, but there was a negligible contribution.

Binu Pathiparampil
Head of Equity Research of Pharmaceuticals, Elara Capital

Got it. Second, on semaglutide, are you also planning for launches in some other emerging markets, around the time you will launch in India?

Kirti Ganorkar
Managing Director, Sun Pharma

No, what I said about the launch in India only. Other markets, we are not guiding what is our launch plan.

Binu Pathiparampil
Head of Equity Research of Pharmaceuticals, Elara Capital

Understood. Finally, a question on GL0034. I believe it is in phase 2 in diabetes. When can we expect some sort of data with it?

Dilip Shanghvi
Executive Chairman, Sun Pharma

No, what, what was that?

Binu Pathiparampil
Head of Equity Research of Pharmaceuticals, Elara Capital

GL0034 in diabetes, phase 2. I think you prescribed?

Dilip Shanghvi
Executive Chairman, Sun Pharma

We are publishing phase 2 data in certain scientific conferences, both for diabetes as well as for NASH over the next few months. But the current phase 2b study, which has started, that should possibly get over within maybe 12-18 months.

Binu Pathiparampil
Head of Equity Research of Pharmaceuticals, Elara Capital

Okay. So any further data is 18 months? Okay, got it. Thank you.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah. Yeah, thank you.

Operator

Thank you. Next question is from Girish Bakhru from OrbiMed. Please go ahead.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Yeah, thanks for taking my question. Just, questions on U.S. again, regarding, two products. First, Leqselvi. My understanding is the product requires a genetic testing before you put the patient on. Can you talk about that? Isn't that a significant deterrent?

Rick Ashcroft
CEO of North America, Sun Pharma

Yes, it is. Well, first, I think it's important to point out for all the JAK inhibitors, there's a whole battery of testing that needs to take place. So that's similar across all the products. Leqselvi is a bit unique in that we do have a specific testing for how the drug is metabolized. Now, what's interesting about that is a lot of drugs are metabolized through that system, so it's good for patients to understand that. So there's some benefits of actually knowing that as part of the testing process. But you're correct, that is one of the steps associated with starting patients on Leqselvi.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Can I ask, Richard, are there enough centers who are doing this testing? And if you can also throw who's covering the cost of the test. Is it the patient or is it the insurance company?

Rick Ashcroft
CEO of North America, Sun Pharma

We're actually covering the cost of the test, so we're working with the leading providers. There are several big providers of testing within the United States, and we are working with them to provide the test, and we do so free of charge to the patient.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Understood. And just while we're on this market, I mean, Rinvoq, of course, is being talked about as a new entrant potentially soon. I mean, I was looking at the data. Data on Rinvoq is pretty solid, and its dosing is also better than Leqselvi. So how do you see that competition coming in this market? And of course, there are a whole set of new drugs also probably being targeted in alopecia.

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I don't know if I would agree with the comment about the dosing being better. I think what I would say is, you know, first of all, this remains a category where there's opportunity for more diagnosis. So the more products that are available is a good thing because it's giving patients choices, and it's going to allow the market to continue to grow. Strictly, the severe market, where it can be challenging for physicians to differentiate those patients. So having additional competition is a good thing because it will help with that education. The other thing we know, and we're seeing with Leqselvi as well, is just because a patient tries more, that doesn't mean they're not going to respond to others. In fact, that's exactly what we're hearing from clinicians.

We're having patients that are starting Leqselvi that have actually failed the two other approved JAK inhibitors and actually are now responding on Leqselvi.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Understood. And second question was on Enloxit. I heard your comment earlier that this primary market is basically new patients. So, I mean, you are not really targeting patients who have failed Keytruda or Libtayo. Is that correct?

Rick Ashcroft
CEO of North America, Sun Pharma

So there could be patients that are having trouble tolerating Keytruda and Libtayo that could move to Enloxit. But in general, our assumption has been, and our strategy has been more focused on new patients.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Wouldn't that market be smaller, like, given the advanced carcinoma patients would be difficult to find?

Rick Ashcroft
CEO of North America, Sun Pharma

Yes. I mean, there are. It's smaller than the overall population, but there's a meaningful population of patients that start immunotherapy, where they need to go on one of these therapies.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Understood. And just lastly, any thoughts on new indications that you're pursuing for Leqselvi or on Enloxit right now, or is it too early?

Rick Ashcroft
CEO of North America, Sun Pharma

We are in active discussions about LCM for both products.

Girish Bakhru
Analyst and Investment Professional, OrbiMed

Understood. Thank you so much.

Operator

Thank you. Next question is from Vishal Manchanda from Systematix. Please go ahead.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Hi, good evening, and thanks for the opportunity. A question on your pending ANDAs and NDAs. So you have 116 ANDAs pending and about 14 NDAs pending approval. Would you be able to share how many of these are from sites that are impacted by OAI?

Dilip Shanghvi
Executive Chairman, Sun Pharma

We don't specifically disclose which ANDAs are filed from which site.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

In the sense, like, just a percentage of the pending ANDAs or NDAs that would be filed from the affected sites.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Like I said, we don't disclose that.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Right. Okay. And if you could share some nature on, nature of the NDA filings that are pending approval, in the sense, whether these are ready-to-use injectables or sprinkle powders that you have been kind of trying to build over time. So majority of these would be kind of ready-to-use injectables and dysphagia-related products?

Dilip Shanghvi
Executive Chairman, Sun Pharma

No, we haven't given details about our NDA filings in terms of the nature. Yeah.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Okay. Just one final one. Do you expect to see further decline in US generic sales in Q4?

Dilip Shanghvi
Executive Chairman, Sun Pharma

I think-

Rick Ashcroft
CEO of North America, Sun Pharma

I don't believe we provide forward-looking guidance.

Dilip Shanghvi
Executive Chairman, Sun Pharma

I mean, it's included in our overall guidance.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Right. Right. And if you could just share, between Enloxit and Leqselvi, which one would become, w hich one would scale up faster over the next two years? Any sense there?

Rick Ashcroft
CEO of North America, Sun Pharma

We typically don't provide product-specific guidance.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Thanks. Thank you.

Operator

Thank you. Next question is from Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Senior Equity Research Analyst, Macquarie

Hi, thank you for taking my question. The first one is on the CMS's proposal on the Most Favored Nation pricing, the two models that they have put out. Can you share some color, what is the internal assessment? I believe right now it's open for the commentary, but what's your internal assessment of that?

Rick Ashcroft
CEO of North America, Sun Pharma

Sure, happy to do so. What I think, as you know, there are three models. There's a voluntary model that exists today, which is called the Generous Model, which is directly related to Medicaid within the U.S. There's, a nd then the other two are proposed, so they are very much in the notice and comment phase. We expect that notice and comment phase to end within this next month. So it's pretty speculative at this point to know, A, whether they will stay intact as they are or how they will change. As you would expect, we are working on all possible alternatives to mitigate any impact.

Kunal Dhamesha
Senior Equity Research Analyst, Macquarie

Can you share how we can make the broader aspect as to how we can mitigate, you know, what are the strategies we can employ there?

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I think there are a variety of ways-

Dilip Shanghvi
Executive Chairman, Sun Pharma

Take your-

Rick Ashcroft
CEO of North America, Sun Pharma

Go ahead.

Dilip Shanghvi
Executive Chairman, Sun Pharma

I think—no, I, I think these are commercially sensitive information. It's difficult for us to share this information on a public call. If you see, none of the pharma companies have given any details about any agreement that they have signed with the government, excepting which products are covered. So I think you need to understand that there are things that we can share, and there are things that we will not be able to share.

Kunal Dhamesha
Senior Equity Research Analyst, Macquarie

Sure, sir. Second one on the front, you know, Cosibeli mab, we, you know, just suggested that we might be in active discussion for new indication. So would this indication be within the therapy areas that we are focusing, or we are willing to go beyond our key therapy areas at this moment, given the data, especially on the immune-mediated adverse events, is quite strong compared to the competitor?

Dilip Shanghvi
Executive Chairman, Sun Pharma

I think once we decide-

Rick Ashcroft
CEO of North America, Sun Pharma

I think we'll go ahead, Jaya.

Dilip Shanghvi
Executive Chairman, Sun Pharma

No, I think once we decide, we will share both the information that we can share. We are. As we've said, we are evaluating. So while we evaluate, there are advantages of staying within the therapy area that we are present in. There are advantages of looking at other areas that we are not present in. So we have to do a commercial risk-benefit and time to market analysis.

Kunal Dhamesha
Senior Equity Research Analyst, Macquarie

Sure. Thank you, and all the best.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah. Thank you.

Kunal Dhamesha
Senior Equity Research Analyst, Macquarie

Thank you.

Operator

The next question is from Gautam from Leo Capital. Please go ahead.

Gautam Singh
Analyst, Leo Capital

Hi, sir. Thank you for the opportunity. Good evening. I wanted to know regarding GLP-1, do you have a fill-and-finish capacity? If it's our own capacity or through partnerships capacity?

Kirti Ganorkar
Managing Director, Sun Pharma

No, I think I talked about launch in India, but we will not comment specifically on capacity, yeah, and whether it's in-house or it's outsourced from a third party, yeah.

Gautam Singh
Analyst, Leo Capital

All right. You guys won't, don't have any timelines or any intention outside India market, any emerging markets, or only India market will be guided as of now?

Kirti Ganorkar
Managing Director, Sun Pharma

No. So as I said earlier, my comment was only on India market. Outside India market, we are not going to disclose what's our plan here.

Gautam Singh
Analyst, Leo Capital

All right. Thank you.

Operator

Thank you. Next question is from Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Thanks for the follow-up. Just on continuing on innovative sales, so while you highlighted high base in the same quarter last year, is there any sort of milestone as well, any certain sort of one-off which would sort of come from a higher base in this quarter as well?

Dilip Shanghvi
Executive Chairman, Sun Pharma

No.

Rick Ashcroft
CEO of North America, Sun Pharma

No, there was no one-off in this quarter, apart from milestone.

Tushar.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Sure. Got it, sir. And, secondly, more on the overall performance of FY 2023 to 2025, there has been, almost, you know, 13%-14% CAGR in EBITDA as well as earnings, even if I adjust for the milestones income. However, FY 2026, 9 months has been a bit of, you know, sort of subdued. So if you could just throw some light, while this 9 months, the R&D spend also has been relatively lesser, given the clinical programs at various stages. So how do we see, w hile not, you know, taking a numerical guidance from your side, but, but directionally, if you could, you know, help us understand?

Jayashree Satagopan
Group CFO, Sun Pharma

I think our margins during this year and quarter has also been good, factoring in the two new launches and the related expenditure that we have decided on. So I think on a normal, when you look at the on a normal ongoing basis, the margins are at a comparable basis.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Ma'am, I was referring for the growth in EBITDA as well as PAT, while higher spend on innovative medicine to some extent got offset with lower R&D spend compared to earlier years. Right?

Jayashree Satagopan
Group CFO, Sun Pharma

Yeah. So that is at the EBITDA level.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

So-

Jayashree Satagopan
Group CFO, Sun Pharma

PAT, we have indicated, in the past as well. Our ETR has moved up from around 13%-15% to currently about 25%, and that is the reason why you would see that the PAT improvement may not be commensurate with the margin improvement.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Okay. So subsequently, is 25% effective tax rate the number to assume for the 2027, 2028?

Jayashree Satagopan
Group CFO, Sun Pharma

I think it would be sort of in the range, we guess.

Tushar Manudhane
SVP and Institutional Research Analyst, Motilal Oswal Financial Services

Got it, ma'am. All right. Thank you.

Operator

Thank you. The next question is from Shashank Krishnakumar from Emkay Global Financial Services. Please go ahead.

Shashank Krishnakumar
Equity Research Analyst, Emkay Global Financial Services

Hi, thanks for taking my question. My first one was on the launch of an auto-injector, Ilumya in Canada. So wanted to get your thoughts that would possibly move beyond the usual physician administered setting. So, do we also have plans to do this in the U.S.? Just want to understand that. And, just a related question, for psoriatic arthritis, is it reasonable to expect a launch towards the FY 2027?

Dilip Shanghvi
Executive Chairman, Sun Pharma

Sure.

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, maybe I can provide you. Oh, go ahead.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Yeah, no, Rick, please respond.

Rick Ashcroft
CEO of North America, Sun Pharma

Yeah, I was going to say, so we've launched a pen for Ilumya in Canada, and as another market, the product is also administered there. It's a different situation within the US. We're currently pleased with the SC administration model, and that's our current intention. As it relates to psoriatic arthritis, we would expect typical FDA review times, as we shared. We did submit the application this past quarter.

Shashank Krishnakumar
Equity Research Analyst, Emkay Global Financial Services

Got it. Thanks, that's helpful. Just a second question on India. So do we also plan to launch sema tablets post-March? Just wanted to check that.

Kirti Ganorkar
Managing Director, Sun Pharma

Right now, as I said earlier, we have approval for semaglutide injection. Yeah. We won't be able to comment on the semaglutide tablet at this moment.

Shashank Krishnakumar
Equity Research Analyst, Emkay Global Financial Services

Sure, sir. Thank you. That's it from my side.

Operator

Thank you. The next question is from Vishal Manchanda from Systematix. Please go ahead.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Thanks again. On the Philogen drug, Fibromun, can you guide if there is a possibility for the drug to get an accelerated approval?

Dilip Shanghvi
Executive Chairman, Sun Pharma

Where?

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

In the US.

Dilip Shanghvi
Executive Chairman, Sun Pharma

I don't think it's here.

Which indication?

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Soft tissue sarcoma.

Dilip Shanghvi
Executive Chairman, Sun Pharma

My understanding is that they don't have a.

Kirti Ganorkar
Managing Director, Sun Pharma

Priority review.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Priority review classification, so.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Mm-hmm.

Dilip Shanghvi
Executive Chairman, Sun Pharma

It's not-

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

So, like beyond that-

Dilip Shanghvi
Executive Chairman, Sun Pharma

I can find out. I'm res-- if I respond, I'll respond without having adequate information. So maybe share the specific question with Abhishek, and we will get back to you with specific information. Because this is a product that Philogen is responsible for development as well as for filing.

Vishal Manchanda
Institutional Equity Analyst of Pharmaceutical, Systematix

Got it, sir. Yeah, I'll do that. Thank you.

Operator

Thank you. The next question is from Vivek Agarwal from Citigroup. Please go ahead.

Vivek Agarwal
Director of Equity Research, Citigroup

Thanks for the opportunity. The question again is related to your M&A strategy. Just want to understand, in case if you find a suitable M&A target, so what kind of the debt you are comfortable with? So are you able to leverage the balance sheet, let's say, 3x of EBITDA? Thank you.

Dilip Shanghvi
Executive Chairman, Sun Pharma

No, I think I said that we are comfortable with raising debt. Now, it all depends on the target's cash flow profile, our confidence that we can repay. Why, why we want to go into an area where we have no specific information, I have to really make worse.

Vivek Agarwal
Director of Equity Research, Citigroup

Yeah, thanks. No problem at all. Just one more question on this global model, Rick. Although you are not commenting on your strategy, but just if I look at the model itself, is there any possibility or how you think about the possibility of this, let's say, getting implemented? Is it practical or can it get delayed or may not be implemented at all? How do you think about this?

Rick Ashcroft
CEO of North America, Sun Pharma

I think that's pretty speculative. I think we need to wait until the notice and comment period is, is over and then, then react. It's hard to tell at this stage.

Vivek Agarwal
Director of Equity Research, Citigroup

Understood. And are you also working with any kind of deal with the Trump administration?

Rick Ashcroft
CEO of North America, Sun Pharma

Can you repeat the question?

Vivek Agarwal
Director of Equity Research, Citigroup

Are you also working with any kind of deal with Trump Administration, like some of the other big pharma companies have entered with?

Rick Ashcroft
CEO of North America, Sun Pharma

We're regularly in conversations with the U.S. government on any number of topics.

Vivek Agarwal
Director of Equity Research, Citigroup

Perfect. Thanks. That's all my side.

Operator

Thank you. Next question is from Forum Parekh from Bank of Baroda. Please go ahead.

Forum Parekh
Fundamental Research Analyst, Bank of Baroda

Thank you for the opportunity. Our emerging markets growth is quite buoyant in this quarter. So I hear that it was led by both generics as well as innovative products. But can we elaborate more on this and give us some direction, like, going forward, how should we look at this region?

Dilip Shanghvi
Executive Chairman, Sun Pharma

All our major geographies in Emerging Markets are doing well in local currency terms, and our constant currency growth for the Emerging Markets business is 13%. While there was a currency tailwind, both generics and innovative businesses have done well, and we don't guide on revenue growth for specific businesses.

Forum Parekh
Fundamental Research Analyst, Bank of Baroda

Okay. My second question is little open-ended, and it's on the India business, GLP opportunity. So given that the market is going to be very crowded, so what are our thoughts? I mean, how excited are we to be in this competitive market? So any thoughts there?

Kirti Ganorkar
Managing Director, Sun Pharma

No, sure. No, no, we are very excited to launch the product on the patent expiry. Yeah, and I think the product will. When the generic product for Sema is launched, it will, it will also improve the access, and the market will expand. Exactly in terms of number of patients or value, we cannot comment on it at this moment, but we are all very excited to launch a semaglutide equivalent generics in India on patent expiry.

Forum Parekh
Fundamental Research Analyst, Bank of Baroda

Sure. And are we to, can we talk or give some direction on the pricing side? I mean, do we want to be very competitive, or how are we going to be on the pricing side? Any color there?

Kirti Ganorkar
Managing Director, Sun Pharma

Sure. Pricing, we cannot comment, but I already told you, like, when the generic comes, it improves the access. Yeah.

Forum Parekh
Fundamental Research Analyst, Bank of Baroda

Sure. No problem. Thanks. Thanks for answering my question.

Operator

Thank you. The next question is from Abdul Kader Puranwala, from ICICI Securities. Please go ahead.

Abdulkader Puranwala
Senior Analyst, ICICI Securities

Yeah. Hi, sir. Thank you for the opportunity. First question is with the generic semaglutide. I believe, we have filed the product in Canada through Taro. Just wanted to understand, you know, what's the status there, and have you heard anything back from the regulator for the filing?

Kirti Ganorkar
Managing Director, Sun Pharma

No, I think I clarified this the second, third or fourth time. It like, right now in this call, we are discussing semaglutide only for India and will be next year.

Operator, we can close the call?

Operator

Sure. Yes, sir. That was the last question in queue. I would now like to hand the conference back to Dr. Abhishek Sharma for closing comments.

Abhishek Sharma
VP and Head of Investor Relations, Sun Pharma

Yeah, thanks, everyone, especially for joining us on this Saturday. If any of your questions have remained unanswered, please reach out to me, or the investor relations team, and we'll be happy to help you. Thank you and have a good evening.

Dilip Shanghvi
Executive Chairman, Sun Pharma

Thank you.

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.

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