Sun Pharmaceutical Industries Ltd

Ladies and gentlemen, good day and welcome to the Q1 FY25 Financial Results Earnings Conference Call of Sun Pharmaceutical Industries Limited.

Thank you. Good evening and warm welcome to our 1st Quarter FY25 Earnings Call. I am Abhishek from the Sun Pharma Investor Relations team.

Welcome and thank you for joining us for the Earnings Call after the Announcement of Financial Results for the 1st Quarter FY25. Our Q1 Financials are already with you.

Thank you, Murali. I shall take you through the performance of our India business.

Thank you, Kirti. I will update on the performance highlights of our US businesses, which includes US portion of Taro as well.

Thank you, Abhay. I will now provide an update on the performance highlights of our other businesses as well as give you an update on our R&D initiatives.

Thank you very much. We will now begin the question-and-answer session. The next question is from the line of Surya Narayan Patra from PhillipCapital. Please go ahead.

Sir, my first question is on the US business. Sequentially, we have seen some kind of sequential decline. So, is it fair to believe that entire part of the slippage sequentially is led by the seasonality factor in the Levulan, that is my first question? And also, the related point is that I wanted to understand whether we have seen any sequential ramp up in the Revlimid sales, because I think the 12 month period would have expired and now this quarter would have fallen in the new 12 month period where the volume share would have gone up. So, despite that there is a slippage. So, hence I wanted to clarify these two points relating to the quarterly slippage what we have seen in US sales?

So, last part, like you said, in the specialty side is because of the seasonality of Levulan. Barring Levulan, which for seasonality reason has declined from the previous quarter, every other specialty product has shown growth. As far as the generic Revlimid is concerned, you should assume quarter 1 number to be similar to the quarter 4 number of prior year.

So, that means we might not have seen any meaningful uptake in the Revlimid that is what we should understand right now?

So, sales of this product will always be a little episodic. So, to estimate regular consistent sales each quarter is difficult.

My second point is, about any update about the Chinese Ilumetri launch, any progress that we have seen because that could be a sizable opportunity. So, I am just continuously trying to get a sense about that?

So, no, I think based on our interaction with the licensee, our sense is that the product is doing well, it is getting accepted in major hospitals and they are happy with the response they are getting from market place and doctors are happy with the clinical outcome the patients are getting from the use of product.

So, then this will be part of the ROW sales or emerging market sales?

It is a product supply and royalty, yes.

And part of the Global Specialty sales?

It will become part of the global specialty. To that extent the sales would be lumpy. It may happen in a quarter, may not happen.

And third point that I wanted to have a sense, in fact in the annual report you have mentioned about building clinical capability in-house, can you just elaborate what is the kind of or what that you want to intend to say about it and in what way that will help us either to the specialty or to the overall business of Sun Pharma?

No, I think clinical development capability helps us consider licensing a product with let us say late Phase-2 development because then we have to do the Phase-3 and all of that ourselves, like also file the product, get regulatory approval, negotiate with the FDA for the label, all of the skill sets and capability help you with ultimate success of the specialty product in the marketplace.

Thank you. The next question is from the line of Bino Pathiparampil from Elara Capital. Please go ahead.

LEQSELVITM litigation, is this injunction a new case that has been filed or an application in an ongoing litigation and when was it filed?

It is a recently filed litigation.

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

Abhay sir, on Winlevi, IQVIA seems to be showing very sharp peaks and dips in prescription trends, but your comment for the last few quarters has been that we are seeing improvement there. Just wanted to

I was saying that we have consciously worked towards improving the realization per prescription, so and that is working well. So, although you may see a drop in the prescriptions, I think the product revenue is growing at a healthy pace on a smaller base of course.

And despite that, you are still seeing growth in the product quarter-on-quarter?

Yes.

And that is in line with expectations as well or do you think that?

It is a conscious strategy that we adopted.

And I know this is very early so for the GLP-1 product, it is just entering Phase-2. Given we don't have a presence in diabetes in the US, how are we thinking about commercialization? Would this be something that we could potentially outlicensed commercialize on own? Or even if I were to ask EM versus US, could we see commercialization earlier in the US for this product? Any color on timelines would help?

Clearly I think. US as well as in Europe, which are large markets, we will not have any front end to commercialize the product ourselves. So, that is a market in which we will consider partnering or even licensing the product. A player who can help us get sensible share of the market because that may also be equally useful for getting better market. In Emerging Markets and in some of the larger markets, we may have our own capacity to bring the product to market our goods.

And would emerging market happen earlier, sir, given it would take time for US?

As on today, there is no plan to conduct separate studies for Emerging Markets, so it will be part of a global trial.

And Abhishek, if I can squeeze in one more question on the R&D, we had given 8% to 10% guidance obviously 1st Quarter significantly lower. Should this step up in the consequent quarters given the timelines haven't really changed for the pipeline?

Yes, I think you should presume a step up in the subsequent quarters.

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

My first question is on US generic business. Now, like you just said, Taro is part of the US business. So, how do you see this business growing? And if you can also update on any update which you have on the Halol plant from FDA perspective?

So, any update on Halol from FDA perspective?

So, I think the idea is that once we are clear, which should be shortly, we will request FDA for a re-audit of the facility. But that is a decision that we will take once we are 100% sure.

My second question is on LEQSELVITM, so this new litigation which Incyte has filed, so obviously you mentioned that you intend to rigorously oppose that motion, but you intend to bring this product into market, so is there a possibility that you look to settle this litigation?

I think especially in the context of the US, either a favorable judgment or settlement will always remain an option.

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

Sir, when we look at our specialty business growth from here on for the next, let us say 2-3 year, what would you be planning in terms of volume growth with a new product growth and pricing mix? In your view what could be the ideal mix in this business and for the new product related growth, would you say that our current pipeline is sufficient to support what you have in mind?

Unlike, say, a market like India where we have been operating for decades now, you have a pretty clear answer on how much is volume, price and other factors that you mentioned, it is very difficult for us, but philosophically, we always work towards growing volumes. The price increase is taken as a bonus rather than the way to grow. So, I think increasing volume, growing faster than the market and increasing share of

And on the LEQSELVITM launch, would you say some of the launch cost is already built into our current quarter P&L or there are more to come?

Obviously, when you launch the product actually in the market, the marketing and sales expenses will be higher than what you see for the current quarter.

Sure, but some of the, let us say, back-end processes like reimbursement or excess personnel, maybe little bit of additional sales force etc., would that be already there in the quarter or that will also?

It would be.

It would come, or it is already there?

It is already there, but it is expected to go up when we actually launch the product there.

And one for CFO sir, what would be your current net cash position as of June 24?

$2.3 billion.

Thank you. The next question is from the line of Amey Chalke from JM Financial. Please go ahead.

The first question I have is on the Taro integration. Is it possible for the management to outline the integration benefits coming out of Taro consolidation, like in terms of manufacturing landscape, etc., is it possible to quantify the impact on the cost or margin.?

So, as on today, as we explained, I think Taro has been operating as an 80% owned subsidiary for a long time. So, there are no major structural changes which are likely as Abhay explained, we are working with a view to create an integrated single organization both for customers as well as for suppliers. That is what is our current plan. So, we are not seeing any significant short-term synergy, but I am sure that as we continue to focus and make our operations more efficient, synergy will evolve. Abhay, you have any point to add.

Not much.

Sir, second question I have is on the US generic market, we have 3 units which have been affected by the regulatory issues. Is it possible to tell how much of our spending pipeline for the US is affected by because of these plants and are there any meaningful launches for the US generic markets in the coming years?

I was saying that critical launches that are important for us in the generic business and we are not dependent on these three plants, but having said that, if I look at the total basket, naturally products that we have filed from these two facilities will be impacted.

Thank you. The next question is from the line of Girish Bakhru from OrbiMed. Please go ahead.

Abhay, just to comment on Ilumya, given it is 4 years to launch, I don't know whether it is possible to highlight if the peak sales here for Ilumya, is it within next 2 years or would you say it still has a long way to go given the IL-23 adoption?

I would think you have a long way to go because we still have headroom to grow in the current indication and when we get the psoriatic arthritis indication, that is an additional segment that opens up for us.

And just related, we have seen two aggressive launches recently, Bimzelx came and has been grabbing a lot of I think prescription share, Sotyktu has also been doing well. I know yours is a more medical benefit product, but any comment you can share on whether the rebating has increased in the class, or the volume growth is a bit of a challenge now?

So, without naming, I think at least one of the two products that you mentioned in my opinion has actually not met expectations of the organization at least. And the class that we are into, that is psoriasis always was highly populated class in terms of number of options. So, I don't think that pressure has increased.

The second question was on LEQSELVITM actually, I know your comments on the launch timeline, but reimbursement for this class has been a very challenging issue. Pfizer also has been talking about that. Possible to comment, have you had any discussions already with payers on the product and if assuming the launch comes, would the update be slower?

I don't really want to go there at this stage, it is evolving. We are engaging with the payers, with the guardrails that we have to maintain prior to the launch of our product. And we feel that there is interest in the payor community for our product. How it evolves, I think let us wait for it and then we will probably give you a little more color.

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

Sir, just with respect to Ilumya for the indication of psoriatic arthritis, where we are in terms of the recruitment of patients, 60%-70% done, 80%-90% done, if you could share some like that?

We have shared the, what you call details about when we expect to file for this product. I think once that is complete, I mean for the sake of clarity, one study is very close to letting completion, because there are two arms of the study, one is biological naive and biological failure patients, so I think hopefully we should meet the timeline, some of these patients are difficult to recruit.

Sir, considering that and considering the other product sort of will do completing the Phase- 2 and sort of topline data in first of CY25, so just trying to understand what would lead to big step up in the R&D spend as far as FY25 is concerned?

You are trying to link up this with the R&D spend?

Sir, not just for Ilumya, but when considering the other products in their current studies, not just specifically?

But we are only sharing details about products which are already in clinical trial. We are not sharing any information related to our plan for initiating any further studies.

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

We have seen a sharp uptake in India revenue in Q1 around 16% year-on-year growth, so if you can highlight what is, we have said that we have seen growth across therapies, but any particular variable affecting this and is this growth momentum sustainable for the rest of the year?

As I said earlier, we are seeing the growth across the therapy and the business is performing well because the majority of our growth is also coming through volume, which also talks about the growth in a

But there isn't any additional channel that we would have focused in this quarter, right, maybe modern trade or something which would have led to higher growth?

No, I don't think there is any additional channel in this quarter.

Our staff cost growth on a year-on-year basis is quite muted. I can see only 2% growth. So, is it related to some of the cost efficiency measures that we have taken and are the performance related wage hikes etc., baked into the current quarter?

No, I think like what we say for majority of the expenses, you look at annualized cost, don't look at quarter-on-quarter. There will be some amount of adjustment or periodicity which may mask actual underlying numbers.

And last one from my side, I think the atopic dermatitis trial readout for SCD-044 has been moved to H1CY25 versus earlier guideline of H2CY24, so what is causing this delay?

I think recruitment of the subject.

And we expect anymore delays here or we are kind of okay in the guidance?

I think idea is that we shouldn't give explanation rather than giving the outcome. That is a position that we try and achieve in all businesses. Hopefully within next some time we should achieve that also in clinical trials because I have never explained our performance. That is because of this reason we did not achieve the numbers. It is better for me to factor everything before I give guidance.

And the last one, since we are on Specialty, we have said that we might look at in terms of out licensing our GLP-1 molecule, right, but do you have any particular timeline in mind as to when in terms of development stage, we would be looking out for partner?

So, my sense is that once we have greater clarity in terms of clinical outcomes, is the best time at which we will start..

Thank you. The next question comes from Sumit Gupta from Centrum. Please go ahead.

So, what is the share of Ilumya in the psoriasis market in the US?

You are talking all categories?

Yes?

Very small. It is like 0.5%. Only IL-23 Class where we will be closer to 8%.

8%?

IL-23.

And how do you expect it to like over the next 4-5 years or over the long term, how do you see it going forward?

Hopefully the idea is to grow.

And sir, any guidance on the overall revenue growth over the next 2-3 years?

No, we don't give long-term guidance.

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

Abhay, just one clarification on IL-23, 8%, this is the volume market share, or the patient market share you are referring to?

This is the prescription market share.

And the second one, Revlimid, so you mentioned it is flat quarter-on-quarter, I remember last quarter it wasn't significant. So, should we assume that it is not significant contributor this quarter and it can increase in the subsequent quarters?

We don't guide product wise. So, for me to give you each product granularity is difficult because we don't guide.

Sir, would you consider it a significant contributor to your revenues in the US at this point because this opportunity is there for a limited time, so just wanted to understand, would you consider it as a significant contributor?

Like it is a limited quantity launch and the quantities that we have are not very high. So, it is one of the important contributors to the generic business. But there are other interesting products that we have in the portfolio as well.

Saion, for this quarter the contribution from Lenalidomide was not large.

Thank you so much. The next question is from the line of Surya Narayan Patra from Phillip Capital. Please go ahead.

My first question is about the field force expansion that we have consistently done over the last couple of years in the domestic formulation side. So, since the exercise of expansion over the 4 year period that we have completed now, so what is the stance here? Are we thinking about further expanding extending into this thing, Tier-1, Tier-2, Tier-3 kind of town, cities like that? And if that is not further getting expanded, then is it fair to believe that now the focus would be on enhancing the productivity of the people that has been added and hence improved margin going ahead?

I don't think what gave you the idea that even while we are expanding the focus is not on improving productivity.

No, in fact, see obviously it takes at least a year or two post the addition of the field force to see a kind of real productivity of the new people. So, that is why I said that okay, since we have consistently been adding people over the last four years, so if we are now focusing more on the kind of optimizing the productivity of the people that has been added in the recent period or what stance that we would be having here?

Broadly, what I am saying whenever we use expansion as a strategy, we always looked at our productivity doesn't get diluted, that is what I can say.

But practically, the sales for this thing, MR in the recent years has to some extent a bit low, although it is not very significant, but it has come down a bit. So, that is why I was trying to understand that whether we will go back to the previous peak and hence improvement there it also from that angle I was coming to this question?

I understand what you are saying, but I think it will not have a big impact.

Similarly, even in the Emerging Market, we have added even around 10% kind of field force test. So, could you share what is the share of the branded market there in the emerging market, branded in the sense branded generic and pure generic and since we are adding people then is it fair to believe that the share of branded generic is likely to go up in the emerging market there also?

So, I think broadly, our entire business, excepting some tenders, almost entire Emerging Market business is branded generics only.

So, then around 9% kind of people addition what we have done in FY24, sir as per the annual report, so whether this is an ongoing practice or this is a kind of a special effort that we have done to boost the branded generic business?

I would not know because there are a large number of countries, but 8%-9% is not a dramatic increase in number of people. Because we have a large see, there are three things which we have to keep in mind.

Thank you. The next follow up question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.

Sir, just on ROW sales in terms of growth has been quite subdued for two quarters. So, just if you could explain the reason for the same and how to think about it going forward?

So, one reason would be possibly because of what you call price cuts and generic product pricing pressure in Japan. But I think we are expecting even that business to be able to continue to do well as time progresses.

Ladies and gentlemen, that was the last question for today. I would now like to hand the conference over to Mr. Nimish Desai for closing comments.

Nimish is still pretty much top of mind, Abhishek here. Thanks everyone for joining the call at this late hour. For any questions that still remain unanswered, you can reach out to the Investor Relations team, and we will be happy to take your questions. Thank you.

Thank you. On behalf of Sun Pharmaceutical Industries Limited, that concludes the conference call.