Sun Pharmaceutical Industries Limited (NSE:SUNPHARMA)
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Apr 24, 2026, 3:30 PM IST
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Q3 23/24

Jan 31, 2024

Operator

Ladies and gentlemen, good day, and welcome to the Q3 FY' 24 earnings conference call of Sun Pharmaceutical Industries Limited. 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 conference 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. Thank you, and over to you, sir.

Abhishek Sharma
VP and Head of IR and Strategic Projects, Sun Pharmaceutical Industries Limited

Thank you. Good evening and a warm welcome to our third quarter FY 24 earnings call. 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, Managing Director, Mr. C.S. Muralidharan, CFO, Mr. Abhay Gandhi, CEO, North America, and Mr. Kirti Ganorkar, CEO of India Business. 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 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 CFO, Mr. C.S. Muralidharan.

C.S. Muralidharan
CFO, Sun Pharmaceutical Industries Limited

Welcome, and thank you for joining us for this earnings call after the announcement of financial results for the third quarter, FY '24. Our Q3 financials are already with you. Q3 FY '24 sales were at INR 121,569 million, a growth of 9.5% over Q3 FY '23 and higher by 1.3% over Q2 FY '24. Material cost for the quarter was at 22.5% of sales, lower year-on-year on account of better product mix, including higher specialty sales. Staff costs came in at 19.4% of sales, higher than Q3 FY '23 on account of merit increase and consolidation of Concert. Other expenses were at 32.3% of sales, higher year-on-year on account of increase in selling and distribution expenses and higher R&D spend, including consolidation of Concert business .

Forex gain for the quarter was INR 1,246 million, compared to a loss of INR 31 million in Q3 FY '23. EBITDA, including other operating revenues, was at INR 34,768 million, higher by 15.8% over Q3 last year. The EBITDA margin for the quarter was 28.1%, compared to 26.7% in Q3 FY '23 and 26.1% in Q2 FY '24. Adjusted net profit, excluding the exceptional items for Q3 FY '24, was INR 25,936 million, representing growth of 19.7% over Q3 FY '23. Reported net profit for Q3 FY '24 stands at INR 25,238 million, as against reported net profit of INR 21,660 million in Q3 FY '23.

The effective tax rate for Q3 FY '24 was 14.1%. Reported EPS for the quarter was at INR 10.5 per share. As of 31st December '23, net cash was $2.3 billion at consolidated level and about $990 million at ex-Taro level. Post reduction of gross debt by $640 million in the first nine months, the closing gross debt as on 31st December '23 was $114 million. Now we will discuss the nine months' performance. Gross sales were at INR 359,451 million, a growth of 10.4% over last year. Material cost for nine months was at 23% of sales, lower than last year, mainly due to product mix, including higher specialty sales.

Staff cost stands at 19.8% of sales, higher vis-à-vis last year on account of annual merit increase and consolidation of Concert. Other expenses were at 31.2% of sales, higher on account of higher selling and distribution and R&D expenses, including Concert. Forex gain for nine months was INR 925 million, compared to a loss of INR 989 million for same period last year. EBITDA for the nine-month period was at INR 99,880 million, a growth of 12.9%, with resulting EBITDA margin of 27.4%. Adjusted net profit for nine-month period was at INR 73,145 million, up 12.7%.

Reported net profit for nine months was INR 69,218 million, compared to INR 64,891 million in the same period last year. Moving on to Taro's performance. Net sales of $157 million increased in part due to new product launches and gross-to-ne t adjustments. Net profit for the quarter was $20.2 million. For the nine months, sales were at $464 million, up by 8.9% due to one-time gross-to-ne t adjustments. Excluding these adjustments, the sales growth was mid-single digit. Net profit for nine-month FY '24 was $38.8 million, compared to $18.5 million in nine-month FY '23. I now hand over to Mr. Kirti Ganorkar, who will share the performance of our India business.

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

Thank you, Murali. I shall take you through the performance of our India business. For Q3, the sales of formulation in India were at INR 37,785 million, recording 11.4% growth over Q3, FY '23. India formulation sales accounted for 31% of total sales for the quarter. Sun Pharma is ranked number one and holds 8.51% market share in the over INR 1,933 billion of Indian pharmaceutical market, as per AIOCD AWACS MAT December '23 report. Corresponding market share for previous period was 8.46%. For the quarter ending December '23, we grew higher than IPM, and we have done well across all major represented therapy areas, and we are growing faster than the market.

As per SMSRC MAT October '23 report, we are number one ranked company, and Sun Pharma is also ranked number one by prescription with 12 different doctor categories. For Q3 FY '24, the company launched 28 new products in India, and we are seeing good momentum in the in-license product that has been launched in the recent past. I will now hand over the call to Abhay.

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Thank you, Kirti. I will update on the performance highlights of our U.S. businesses. For Q3, our overall sales in the U.S. grew by 13.2% to $477 million. The growth was driven by specialty business, including ILUMYA, CEQUA, and Winlevi, but partially offset by impact of ongoing Halol and Mohali facility issues in the generics business. U.S. accounted for over 33% of total sales for the quarter. U.S. specialty business has continued to do well and has grown over Q3 FY '23. The underlying business and the prescription trend for the specialty business remains strong. For Q3, we launched three generic products in the U.S. on an ex-Taro basis. I will now hand over the call to Mr. Shanghvi.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you, Abhay, and thanks all the participants. 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 market were at $252 million for third quarter, lower by around 2.3%. The underlying growth in constant currency terms was about 5.2% year-on-year. Emerging markets accounted for 17% of total consolidated revenue for Q3. Amongst the larger markets, in local currency terms, Brazil and Romania have done well. Formulation revenues in rest of the world were $214 million, up by 12.9%. ROW markets accounted for approximately 15% of consolidated Q3 revenues. We continue to invest in building a R&D pipeline for both the global generics and the specialty businesses.

Consolidated investment towards R&D for Q3 '24 stands at INR 8,245 million, 6.8% of sales. Specialty R&D accounted for 39.2% of our total R&D spend for the quarter. Moving on to updates on global specialty. In Q3 '24, our Global Specialty sales were up by 26.1% to reach $296 million. This includes a milestone payment from Almirall of $20 million, received in Q3 '24. Excluding milestone payment, the growth is 24.2%. We've also disclosed that our partner product, Nidlegy, should be filed with European authorities during the first half of current year. Once approved, Nidlegy will enhance our oncology offerings in skin cancers and synergize well with our growing Odomzo franchise in Europe.

Phase III trials of MM-II and Phase II trials of GL0034, both are expected to start in early '24, are now moved with expected start date in second half of '24. Among recent events, Sun has entered into a definitive agreement with Taro to acquire the minority shares at $43 per share, subject to certain closing conditions. The agreed price of $43 per share is poised to deliver 48% premium to unaffected price on May 25, '23. The fully combined entity will be better positioned to service patients globally. As all of you are aware, this is finally to be approved by minority shareholders of Taro and subject to closing by that. I will now hand over to Murali for his final comments.

C.S. Muralidharan
CFO, Sun Pharmaceutical Industries Limited

In addition to the financial performance and business highlights shared earlier, the board has declared an interim dividend of INR 3.50 per share for the year FY '24, against INR 7.50 per share interim dividend for the previous year. With this, I would like to leave the floor open for questions. Thank you.

Operator

Thank you. We will now begin with the question and answer session. Anyone who wishes to ask a question may press star and one on their touchtone phone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets only while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Analyst, Macquarie

Hi, thank you for the opportunity. Good evening, everyone. So first one on the specialty. Let's say we are growing strongly and the prescription trends are also strong. But from here on, when we see our key products like ILUMYA, CEQUA, and Winlevi, what type of incremental PNL investments are required for us to grow in the U.S. market?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

The question was what, what kind of PNL investment?

C.S. Muralidharan
CFO, Sun Pharmaceutical Industries Limited

Additional investment.

Kunal Dhamesha
Analyst, Macquarie

PNL.

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Additional investment. Okay. So, I mean, there will be additional investment based on the trajectory of the products that we see in the budgets that we take for next year. So that, as we go along, we will have more clarity because we are right now into the budgeting cycle, so I don't have complete visibility. But, yeah, we will continue to invest on the products and find ways to keep growing.

Kunal Dhamesha
Analyst, Macquarie

My, my question is more like what kind of, you know, spend, whether it would be more, people on the sales force, more marketing, you know, or more, let's say, coupon strategies, et cetera. What, what those incremental investment in, in which kind of, you know, line item will be investing? Qualitatively, I don't need quantitative, but qualitatively, what is the investment line item that we see from here on?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

For each product, I think the strategy will always be different. There is no one thing that I can simply say that in this line, the expenses will move up or down. Beginning of each year, we look at each product, what are the opportunities for us to grow? Where do we need to invest? Where can we optimize investment? That's how we work out our budgets almost from a zero base. I cannot give you a straight simple answer that in a particular line it will move up or down, but it'll be definitely a growth-oriented budget is all I can say.

Kunal Dhamesha
Analyst, Macquarie

Okay. And based on whatever investment we plan, we think that we can continue to grow at the current trajectory level?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

I mean, that's what we try to do in every given product and in every given market.

Kunal Dhamesha
Analyst, Macquarie

Second question on ILUMYA. For a product like ILUMYA, do you think that out-of-pocket cost could be a major deciding factor for a patient or a provider, to basically take the drug or not?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

I mean, that's the answer is a yes for every given product in the U.S., because you have, you know, a very large majority of the population being insurance covered. Out-of-pocket is a consideration even if you buy a simple antibiotic or whatever product you can think of. It's always a consideration.

Kunal Dhamesha
Analyst, Macquarie

No, but given ILUMYA is basically, you know, a very specialized product, right? And it requires prior authorization, step therapy and all those things. So, you know, not every option would be available to a patient when he reaches or she reaches to ILUMYA. So from that perspective-

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Yeah, as I said, this is not... I mean, just don't consider this to be unique to ILUMYA. It's a specialized product, I agree. But this is a situation that every product that you launch in the U.S. will have to undergo and face, and this becomes an important consideration for both the doctors as well as the patients in deciding a treatment option.

Kunal Dhamesha
Analyst, Macquarie

Okay. Thank you. I have no question. I join the people.

Operator

The next question is from the line of Damayanti Kerai from HSBC Securities and Capital Markets India Private Limited. Please go ahead.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Hi. Thank you for the opportunity. My first question is on U.S. generic business, ex- which is excluding Specialty and Taro. So can you elaborate on two points, please? Was there significant contribution from REVLIMID during the quarter? That's first. And second, can you comment on supply pickup, which you might have seen from Mohali plant?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Generic REVLIMID sales were very small in this quarter.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Okay.

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Similarly, if I see the Mohali impact, supplies are clearly not normal. Situation is the same as we saw in quarter two, and we are working to fix those issues, and that will happen gradually over time.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Regarding Mohali, can you like comment what are the key bottlenecks? Because if I understand correctly, there has been clearance by the FDA to recover your supply, et cetera, right? What are the bottlenecks here?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

I think it's deciding which products to come to market, in what priority, and also making sure that the quality clearances as mandated are done, and that takes its own time. And these are two of the issues that the plant is trying to resolve, along with getting back to compliance as a plant in general.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Okay. My second question is on Taro business. So what are your priorities for the Taro business after signing the definitive merger agreement? So whether you'll focus more on reviving the legacy derma portfolio, or you'll focus more on turning around Alchemy franchise?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

So I don't think the merger has been consummated as yet. So therefore, I think we should not be discussing future strategies for Taro, because this process is still on. Mr. Shanghvi explained that we still need the approval of the majority of the minority, and of course, certain other steps to be followed. It's only then can we get into the discussions. It's too soon now, premature.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

The other thing, Abhay, is that we are, in any case, controlling shareholders, so we've been managing the business because we are part of the management. So there will not be any dramatic or significant change in the overall company and its strategy.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

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

Operator

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

Neha Manpuria
Analyst, BofA Securities

Thanks for taking my question. Abhay, on, you know, ILUMYA, if you look at the IQVIA data, you know, it's seeing very good traction, you know, in the last year. Incrementally from here, you know, where, what are the incremental pockets of growth, and how should we look at, you know, expansion in ILUMYA or continued expansion in ILUMYA versus the risk of biosimilar Humira probably eating up, you know, some of that, prescription? Is that a concern at all?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Let me answer the second part of your question, because the first part, you know, to speak on strategy is very difficult for me, because this call is not only for investors. So I would not like to give a granular strategy on how I will find ways to grow from. But Humira, which you said biosimilar, is an evolving space. We are also studying constantly of what is happening. As of now, we don't see any impact on ILUMYA. We don't foresee that. But it's an evolving space, and I guess more to come, more to learn, and we will then have to factor that into our thinking. But as of now, we don't see any impact.

Neha Manpuria
Analyst, BofA Securities

Understood. And for CEQUA, we have seen, you know, share come off pretty sharply because I think generic Restasis seem to have picked up share. So, you know, do you think, you know, CEQUA can continue to grow despite the fact that, generics seem to be eating away, on the Restasis share? Because, we've seen CEQUA share also come off pretty sharply in the, recent weeks.

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Then that's what we, you know, wish to do, and we are planning accordingly. Having said that, the space is also getting competitive. There have been new launches by others in the dry eye space with different mechanism of action. So it, the competition is clearly higher than what it was a year ago in terms of options available to doctors.

Neha Manpuria
Analyst, BofA Securities

In that light, do you think, you know, we could grow the CEQUA franchise from here?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Well, as I said, that's what we will definitely be trying to do.

Neha Manpuria
Analyst, BofA Securities

Understood. My last question, the U.S. generic business, did we see improvement in that quarter-over-quarter, ex Taro U.S. generic business? Would that be a fair assumption?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Quarter-on-quarter, you can assume it is flattish.

Neha Manpuria
Analyst, BofA Securities

Okay. Got it. Thank you so much.

Operator

Thank you. The next question is from the line of Harith Ahamed from Avendus Spark. Please go ahead.

Harith Ahamed
Director of Equity Research, Avendus Spark

Hi, thanks for the opportunity. So the 20 million milestone income that you booked, as part of your specialty sales, under your geographic breakup of sales, this comes under which segment?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

It comes under the rest of the world.

Harith Ahamed
Director of Equity Research, Avendus Spark

Okay. And, and my second question is on, this, specialty asset, GL0034. I understand you're developing it for, diabetes indication. Given the opportunity in the obesity, space, will you be developing this for obesity indication as well? And, and, given that, this is such a large opportunity, is there a way to kind of accelerate the timelines of development if, you are targeting the obesity indication?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

I think it's premature for me to share with you, because these are very expensive studies. Once we decide, then we will share as to what is the likely cost and what impact it will have on our short-term profitability.

Harith Ahamed
Director of Equity Research, Avendus Spark

Can you confirm that we are also targeting the obesity indication apart from the diabetes indication for this candidate?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

No, we are evaluating its potential use in multiple indications, but I can't confirm anything that which indication we are developing. So what we have said is that the Phase II study on GL0034 will start in the second half of next year. We haven't said indication.

Harith Ahamed
Director of Equity Research, Avendus Spark

Okay, got it. Thank you. That's all for myself.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Yeah. Thank you.

Operator

Thank you. The next question is from the line of Surya Narayan Patra from PhillipCapital India Private Limited. Please go ahead.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Yeah, thanks for this opportunity, sir. So my first question is on the Ilumetri getting included in the national reimbursement list of China. Generally, it is believed to be a kind of a big achievement for any molecule within just six months of, or, or a couple few months of, marketing approval, getting in, getting listed into the national reimbursement list. So that is considered to be a big development, big achievement, and instant access to the 94%, 95% of the population. So considering that, what update that we are having, sir, for this? And is it fair to believe that this could be a kind of for ILUMYA, it could be the outside of U.S., it could be a kind of biggest... China could be the biggest market?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

No, I think, there are multiple but business issues to fix before we can respond to your question. Currently, ILUMYA is, or Ilumetri is approved as an imported formulation, and we really don't know how aggressively the prices will be cut in China. So be difficult for me to respond, but it's going to be an important market for ILUMYA going forward.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Going forward means, FY 25 onwards, because, it, this is effective from the first January '24, so then the next year will be an important year for us from China side.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

No, I agree.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Okay. Okay. And so is it a kind of a royalty-based model here in China, or it is?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

No, it's a business transaction where it's structured in such a way that economics are shared between us and the licensee.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Okay. Okay. My second question is on the REVLIMID. Let's see, in fact, it looks like that from the prescription trend, there is a substantial improvement in the recent months. So, we know that REVLIMID is not fully captured by the retail prescriptions. So how should we see and believe that whether the REVLIMID practically has seen a kind of multiple growth in the recent period for the entire of the market, the way it has been reflected in the prescription trend, or the growth is just some some double-digit growth, or how should we see and understand that trend?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

On a longer timeframe period, you should look at it more as a stable product.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Stable and steady growing, or it is a stable product, that is how we should see that?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

A steady growth, but, not a very high growth.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Is it fair to believe this is the biggest product after ILUMYA in the specialty basket?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

I mean, we don't give those product-wise details.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Okay. Just last one clarification here, sir. Regards R&D, obviously, because of the direct relationship, so the R&D spend in the current year has obviously seen a kind of meaningful growth in the current financial year. But, considering the pipeline progress, what we have indicated, so going ahead, how significant progress that we should really build for the R&D spend going ahead?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

So when we share the next year's guidance, we will share the R&D guidance also.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Okay. Because this year, despite the Concert acquisition and all that, so it is still lower than the given guidance of 7%. So-

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Yeah. Last quarter was 6.8%.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Yeah.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Hopefully we will touch the lower end of the guidance.

Surya Narayan Patra
Research Analyst, PhillipCapital India Pvt Ltd

Okay. Sure, sir. Thank you. Wish you all the best.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

Thank you. The next question is from the line of Saion Mukherjee from Nomura. Please go ahead.

Saion Mukherjee
Managing Director and Head of India Equity Research, Nomura

Hi. Thanks for taking my question. Sir, in the backdrop of the recent Phase III data of Nidlegy, if you can, you know, talk about the opportunity in, you know, Europe and other markets where you have the right, and your thoughts about this product for the U.S. market. Is that something you are considering?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Sure. So I think the team in Europe is excited about the potential for Nidlegy, and the data clearly is quite impressive. And in a set of patients which are difficult to treat, I think it has good overall success rate. So we're looking forward to getting the product approved and then subsequently launching the product in Europe. Abhay, would you like to respond about Nidlegy for U.S.?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

As you know, sir, we are evaluating, and in due course of time we'll take a decision whether it's something we want to launch in the U.S. as well.

Saion Mukherjee
Managing Director and Head of India Equity Research, Nomura

Sure. So, just, I mean, is it possible... I mean, are there any products which would kind of compete with that? Or, you know, is that something which you find—you think would be one of its kind, that would be launched? And any assessment on how big this product can be, if you can, you know, give us some idea about that.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

No, the treatment protocols in the U.S. are very different from Europe. The neoadjuvant treatment with systemic treatment is much more common than in Europe. So we have to wait for the U.S. study to come out so that we will get the relative benefit of the product, along with the checkpoint inhibitors.

Saion Mukherjee
Managing Director and Head of India Equity Research, Nomura

Okay. Thank you.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

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

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Thanks for the opportunity. I have a question on Sezaby. So do you expect the U.S. FDA anytime this year to allow you market exclusivity under the DACE Act?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

We have made the applications to the FDA, and we are awaiting clarity on how they would like to proceed with it, so I don't have visibility on any particular timeline.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Okay. Okay. And, second question on Winlevi. If you could share, what percentage of the prescriptions are still under the patient assistance program?

Abhay Gandhi
CEO of North America, Sun Pharmaceutical Industries Limited

Maybe we will not be able to answer that question.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Okay. Just one more. Out of the pending ANDA filings, would you be able to share a number as to how many of these would be depot injectables or peptides?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

We don't give too much information about pipeline.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Got it. Okay, thanks.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

Thank you. Participants may press star and one to ask a question. The next follow-up question is from the line of Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Analyst, Macquarie

Thank you for the opportunity again. Just coming back to Nidlegy. If you could share some aspects on the addressable market size in terms of patients, et cetera, in the European market, would be good. I think melanoma incidence is around 100,000 patients a year, but then, you know, I think our product is neoadjuvant setting, so I'm not sure how much, you know, that fits into the regimen, how many patients?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

I think our overall calculation was less than 10,000 patients.

Kunal Dhamesha
Analyst, Macquarie

Mm-hmm.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

But even at that number, it's an interesting product.

Kunal Dhamesha
Analyst, Macquarie

And then, let's say in terms of value, you know, value add of that treatment, versus the usual course of treatment, which is generally surgery, you know, how would you put, you know, Nidlegy as of now? And would that be a consideration when you go to payers, you know, once the approval is in place?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

... I think there is a structured process for getting pricing approved in Europe, which is different in different geographies, but we will have to follow that process in each country.

Kunal Dhamesha
Analyst, Macquarie

Okay. And that would be directly correlated to the value add or the kind of, you know, quality improvement, et cetera, or how does that kind of follow?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

That's what I'm saying, is that different countries have a different way to look at valuation and pricing. So we have to adapt to that, and file for appropriate pricing of people.

Kunal Dhamesha
Analyst, Macquarie

Sure, sure. And the next one on ILUMYA, it's roughly now around, you know, six years since the launch. Typically a product like ILUMYA, how does the, you know, product life cycle behave? If you could share, you know, some light there.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Question. I mean, what is the question?

Kunal Dhamesha
Analyst, Macquarie

So basically, growth phase, maturity phase, you know, how do you think about that product?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

I mean, as on today, looking at the overall performance, not only us, but all IL-23 products are in growth phase.

Kunal Dhamesha
Analyst, Macquarie

Mm-hmm, mm-hmm. Okay. Okay. Thank you, and all the best.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Yeah. Thank you.

Operator

Thank you. The next question is from the line of Sanjay Kular from Acme Private Limited. Please go ahead.

Sanjay Kular
Analyst, ACME Pvt Ltd

Thank you for giving me the opportunity. First of all, compliments to your team for giving excellent results. Sir, in the light of a good result in Q3 and overall nine months performance, are you planning to increase guidance for the current year and for the next year? That is one question. Second question is, you know, you are a company sitting on $2 billion plus cash and cash equivalents, plus we are generating annual cash flow of, you know, $1 billion plus. So are you planning to give giving back such, you know, excess cash to shareholders by way of cash, in, by, by way of buybacks or increased dividends? Thank you very much, sir.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Sure. No, I think if you look at our last quarter performance, we've come in at high single digit growth, so there's no need for us to, at this point of time, revise the guidance, because it's not something where we are consistently, significantly higher. So that's one. Second, I think, is about the dividend. So I think we have a dividend policy of 30% distribution, or 30-35% in that range. And we, we wish to continue to follow that as a process. And about the cash with the company, I think the idea is to potentially look for appropriate investment opportunities. And looking at some of the corrections which have taken place, I think we see some interesting opportunity that we should be able to work on.

So there's no plan to return this cash to investors, because we think we can continue to generate double digit return on our investment. Because if you would have seen over the last few quarters, our return on invested capital has consistently gone up.

Sanjay Kular
Analyst, ACME Pvt Ltd

Yes, sir.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Right. Thank you.

Sanjay Kular
Analyst, ACME Pvt Ltd

Thank you very much.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

Thank you. The next follow-up question is from the line of Mr. Vishal Manchanda from Systematix. Please go ahead.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Thanks for the follow-up. I have a question on ILUMYA. So wanted to understand the profile of patients that are being onboarded for treatment on ILUMYA. Basically, are these patients who have failed treatment on multiple lines of biologics? Or, so would majority of these patients kind-

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

If you see any IL-23 and ILUMYA also, there is a good mix of treatment-naive patients who get onto the product, along with almost an equal proportion of patients who have failed on some other product before they come on to ours.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Okay. So you mean to say it's broadly similar in treatment, biologic treatment, naive, and those who have tried multiple lines of treatment also?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Yeah. Treatment failure, multiple may not be the case, but treatment failure on any other biologic.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Okay. Okay. Thank you.

Operator

Thank you. The next question is from the line of Damayanti Kerai, from HSBC Securities and Capital Markets India Private Limited. Please go ahead.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Hi. Thank you for the opportunity again. I have a question. Due to situation in Red Sea, are you expecting any sort of supply chain disruption in coming quarters or so? And, what kind of preparations you are undertaking in case situation doesn't normalize in, say, near term?

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

... So we are closely monitoring the situation, and our primary objective is to ensure continual supplies, and as appropriate, we will use the channel of shipment between air versus sea, and we are closely monitoring the situation.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Okay. But as of now, are you building in, like, are you stocking up for key markets, or you are, like, still evaluating the situation? You haven't started stock build-up for key markets?

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

No, we have our inventory norms, and we have the overall stock limits, what is set within our process, both in the country and in the manufacturing location and transit. So as we are closely monitoring, I think we are under control.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Okay, my second question is on India business. So, this year, I think what we have seen in the market, volumes are a bit muted, and then, price hike and new launches finally, pulled the growth. So what are your expectations for next year? Like, do you think, market will see sufficient, volume recovery and then, we could see much better, growth than what we have seen in this year?

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

Yes. What I can say is, we have done well with all the therapies, and we are performing better than the market. So in terms of our growth, as I, as we have said, you, 11.5-4% is our growth, but majority of the growth, like two-thirds of our growth, is led by both volume as well as new products put together. In contrast to that, if you look at the IPM, IPM growth, the majority of the growth, almost, like 70%-75% of the growth, is coming from pricing. So I think we are moving in a right direction, and we are focusing on generating prescriptions so that, we remain in line with market or slightly ahead of market in terms of growth.

Your question on next year is very difficult for us to predict what the market will be next year, but the endeavor for us is always to grow in line with market or better than market, whatever the growth the market will have in coming years.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets India Private Limited.

Okay. Thank you. Thank you for your answers.

Operator

Thank you. The next follow-up question is from the line of Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Analyst, Macquarie

Thank you for the opportunity. This is a question on our hedging policy. So where I'm coming from is basically, let's see, constant currency growth for emerging market was 5.4% versus reported growth was around 2.5%. But does that get recaptured somewhere in the hedging gains that we have posted, not just for emerging market, but for other market as well, and how much we are hedging right now?

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

Yeah, our current hedging policy is a board-mandated hedging policy, and we comply with that at this point of time, and we would not like to articulate what our hedging strategy is at this point of time.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Yeah, but specifically for emerging market, for many countries, the cost of hedging itself is so high that from an economics point of view, it doesn't make economic sense. Say, like Russia, Brazil, these countries, hedging costs are quite high. So it's difficult to take those kind of decisions where, and currency can fluctuate much more.

Kunal Dhamesha
Analyst, Macquarie

Mm.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

So we do hedge a few currency pairs, which we have some visibility and some clarity on, but it's still a much more smaller subset of currency and smaller percentage of overall international business.

Kunal Dhamesha
Analyst, Macquarie

Sure, sure. And second one on the, GLP-1 opportunity for India, are there any incoming, opportunities where we can in-license for India market? Or, even for India market, you would be betting, for our own internal molecule?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Which product will you say?

Kunal Dhamesha
Analyst, Macquarie

GL, GLP-1 agonists.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Okay. So what is your question? Whether we would look at our products or look at licensing some other product?

Kunal Dhamesha
Analyst, Macquarie

For India market, yeah.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

For India market, as we have said in last two quarters, we have launched three product which was in-licensed from various companies. Our focus is always to look at opportunities like GLP-1, which we can license to, from the innovator companies.

Kirti Ganorkar
CEO of India Business, Sun Pharmaceutical Industries Limited

Regarding our own GLP-1, it's still early stage. It is under development and just completed Phase I. So...

Kunal Dhamesha
Analyst, Macquarie

Mm. Great. Thank you.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

Thank you. We have a follow-up question from the line of Vishal Manchanda from Systematix. Please go ahead.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Question on GLP-1. Just wanted to understand, with there being two oral synthetic molecules that are being developed in late stage, so does it make sense to develop a peptide GLP-1?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

There are some 30 GLP-1 injectables under different stages of development. Once-a-week injection from a patient point of view, depending on the incidence of side effect, is not a huge negative, especially because both, Ozempic and Mounjaro have become very successful product with millions of patients. There is a increasing acceptance of once-a-week injectable product. We believe that with our overall performance that we've seen in healthy subjects for our product, it has a compelling therapeutic efficacy likely to be there when the product comes to market. We will be developing it.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Got it, sir. Thank you. And sir, just one more on ILUMYA. If you could share, what percentage of the patients would be dropping out of ILUMYA in a year because of either lack of efficacy or, maybe, lack of durability of response?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

I don't have the exact number in my head right now. I can share it to Abhishek later for you to follow up, but it's a very small, percentage compared to what we get. But I can share the numbers separately. Abhishek.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

It should be low single-digit %, ballpark?

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Don't recall, sir. I don't want to give a wrong answer. I will send the details to Abhishek, you can subsequently check with him.

Vishal Manchanda
SVP of Institutional Research on Pharmaceuticals, Systematix Group

Okay. Thank you very much.

Operator

Thank you. Ladies and gentlemen, that was the last question for today. I now hand the conference over to Dr. Abhishek Sharma for closing comments.

Abhishek Sharma
VP and Head of IR and Strategic Projects, Sun Pharmaceutical Industries Limited

Thanks, everyone, for joining us at this late hour. If you have any unanswered questions, please do feel free to contact me. Get in touch with us. We'll be happy to address all your questions. Thank you.

Dilip Shanghvi
Managing Director, Sun Pharmaceutical Industries Limited

Thank you.

Operator

On behalf of Sun Pharmaceutical Industries Limited, that concludes this conference call. Thank you for joining us. You may now disconnect your lines.

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