Sun Pharmaceutical Industries Limited

Sun Pharmaceutical Industries Limited

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Q4 FY2026 · Earnings Call TranscriptMay 22, 2026

Operator

Ladies and gentlemen, good day and welcome to the Sun Pharma's Q4 FY26 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 this conference, please signal an operator by pressing * then 0 on your touch-tone phone. Please note that this conference is being recorded.

I now hand the conference over to Dr. Abhishek Sharma, Vice President and Head of Investor Relations and Strategic Projects.

Thank you and over to you, sir.

Abhishek Sharma

Thank you. Good evening and a warm welcome to our fourth quarter and full-year FY26 earnings call.

I am Abhishek from the Sun Pharma investor relations team. We hope you received the Q4 financials, the press release, and the earnings presentation that were sent out earlier in the day.

These are also available on our website. We have with us today Mr.

Dilip Shanghvi, Chairman; Mr. Kirti Ganorkar, Managing Director; Mr.

Aalok Shanghvi, Chief Operating Officer; Ms. Jayashree 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 transcript will also be put on our website shortly.

As Sun has formally announced the acquisition of Organon and company. Disclosures regarding the acquisition including strategic rationale, timelines, and pro forma headline financials have already been shared through our exchange filings and discussed during the recent investor call.

Since Organon remains a publicly listed company, today we will not be taking any questions regarding Organon's business performance, including recent quarterly results. 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. Jayashree Satagopan.

Jayashree Satagopan

Good evening, all, and welcome and thank you for joining us for the earnings call after the announcement of financial results for the fourth quarter and full year FY26. The financials are already with you.

As usual, we will look at the key consolidated financials. During the fourth quarter of FY26, sales were at ₹145,598 million, registering a growth of 13.6% vis-à-vis Q4 FY25.

Gross margin was at 80.8% for the quarter, higher than the same period last year largely on account of better product mix. EBITDA for the quarter was ₹39,542 million, an increase of 6.4% over Q4 last year.

EBITDA margins came at 27.1%, lower both on year-on-year, which was 28.7%, and on a quarter-on-quarter, which was 31.9%. Forex gain for the quarter was ₹4,268 million.

Ex-forex, EBITDA margins were lower quarter-on-quarter due to several factors, including lower milestone income, some seasonality, reduced contribution from lenalidomide in Q4 versus Q3, and higher spend in certain geographies including U.S. Some of these spends were elevated for the quarter, and we should see normalizing in the subsequent quarters.

Reported net profit after tax for Q4 FY26 was ₹27,140 million, while adjusted net profit for the quarter was ₹27,507 million. Earnings per share for the quarter was ₹11.31 per share.

Effective tax rate for the quarter stood at 22.3% vis-à-vis 19.8% in Q4 of FY25 and 24.3% in Q3 of FY 26. Balance sheet continues to be strong with a net cash of $3.2 billion at the consolidated level.

Now we will discuss the full-year FY26 performance. For the full year FY26, sales were ₹582 million 582 million, a growth of ₹ sorry, a growth of 11.9%.

Gross margin was at 80.2% for the full year FY26. EBITDA came in at ₹177,314 million, a growth of 16.1% with a resulting EBITDA margin of 30.3%.

Adjusted net profit for the full year was ₹124,015 million. The board has approved a final dividend of ₹5 per share for the year FY26.

This is in addition to the interim dividend of ₹11 per share, taking the total dividend for the year to 16 rupees per share. This is same as prior year FY25.

I will now hand it over to Kirti, who will share the performance of our global innovative medicines business and the India business. Yeah.

Kirti Ganorkar

Thank you, Jayashree. I shall first provide you an update on global innovative medicine.

In Q4 FY26, our innovative medicine sales were up 20.1% to reach US $354 million. Global innovative medicine sales for the full year FY26 were US $1,420 million with a growth of 16.8%.

This business accounted for 22.2% of the share of Sun's sales for the quarter. The performance of this business unit continues to be driven by growth across U.S.

and ex-U.S. market, as well as Ilumya and other products such as Odomzo, Cequa, and Winlevi.

Global Ilumya sales for FY26 were US $796 million, having growth of 16.7% for the year. This does not include in-market sales of our alliance partners.

During the quarter, US FDA accepted the review of BLA of Ilumya for the treatment of adults with active psoriatic arthritis with regulatory action date set for late October 2026. Now coming to India, the sales of India formulations were ₹48,359 million for the quarter, recording a growth of 14.8%.

India formulation sales for the full year were ₹192,904 million, recording a growth of 14%. India sales accounted for 33.2% of total consolidated sales for the quarter.

During Q4, we launched semaglutide injection under the brand name Noveltrit and Sematrinity in India across all the strengths. Sun Pharma is ranked number one and holds 8.4% market share in over ₹2,450 billion Indian pharmaceutical market as per Pharmatrac MAT March '26.

Corresponding market share for the previous period was 8.1%. I am pleased to note that this year we have seen the highest gain in market share for Sun since Ranbaxy acquisition.

For the quarter ending March '26, we grew higher than IPM, and we had done well across all major represented therapy areas. The sales growth continues to be led by higher contribution from volumes, new products introduction as compared to overall market, where the price increases is the key growth factor.

Our volume growth of 6% for the quarter beat IPM volume growth, which came at 1.6%. As per SMSRC November-February '26 report, we continue to be the number one company based on the prescription volumes.

Sun Pharma is also ranked number one by prescription with 11 different doctor categories. For Q4 FY26, the company launched 11 new products in India.

Now I will hand over Rick for the update on the US market.

Richard Ashcroft

Thank you, Kirti. Let me share the performance highlights for our US business.

Overall, the US business reported sales of $459 million US dollars for the quarter, declining by 1.1%. US sales for the full year fiscal 2026 were US $1.9 billion, recording a marginal decline.

For both the quarter and the full year, growth in innovative medicines was offset by lower sales in the generic business due to additional competition in certain products. The US accounted for 28.8% of consolidated sales for the quarter.

As we launched Unloxet in the US during the fourth quarter, and we also launched two new generic products in the US. I'm also pleased to note for the year that innovative medicines crossed $1.1 billion for the first time in the United States, having had a strong trajectory since the launch of Ilumya and contributed to by products including Cequa, Odomzo, and Winlevi.

Innovative medicines is now the larger of the businesses in the US when compared to generics. I will now hand over the call to Aalok for updates on our other businesses.

Aalok Shanghvi

Thank you, Rick. I will provide an update on the performance highlights of our other businesses.

Our formulation revenues in emerging markets were US $306 million, up by 17.4% over Q4 last year. Emerging markets accounted for 19.2% of total consolidated revenue for Q4.

The underlying growth in constant-currency terms was 6.5%. For the full year, for the full financial year FY26, formulation revenues in emerging markets were US $1.265 billion, up by 13.6% with a constant-currency growth of 8.2%.

While branded generics has continued to grow, innovative medicines has been an important new driver for growth in emerging markets for the year, with Ilumya doing well across several several markets, such as Romania, Brazil, and as well as the partner market of China. Formulation revenues in rest of the world for the quarter were US $220 million, up %.

For the full year FY26, ROW sales were US $969 million, up 14.4%. Innovative medicines led by Ilumya and Odomzo have been the key drivers for growth in ROW, including sales in non-alliance markets.

Rest of the world markets accounted for approximately 13.8% of consolidated revenue. I will now hand over to Mr.

Dilip Shanghvi for updates on R&D.

Dilip Shanghvi

Thank you, Aalok. Let me now take you through our R&D initiatives.

We continue to invest in building a R&D pipeline for both the global generics and the innovative medicines business. Consolidated investments towards R&D for quarter four FY26 stands at 9,757 million or 6.7% of sales.

Innovative R&D accounted for 36.9% of our total R&D spend. On the guidance, we expect high single-digit consolidated top-line growth for FY27, based on our current understanding of the regulatory and macro environment.

We expect our FY27 R&D spend to be 6% to 7% of the sales for the next year. Further to our announcement of Organon acquisition, we've set up an Integration Management Office and have initiated activities for Day 1 preparedness.

The regulatory filings in various markets is in progress. We expect the acquisition to be completed in Q4 FY27.

Abhishek Sharma

That's the end of our prepared remarks. Operator, if you can ask for Q&A?

Operator

Certainly, sir. Thank you very much.

We will now begin the question-and-answer session. Anyone who wishes to ask a question may press * and 1 on their touch-tone telephone.

If you wish to remove yourself from the question queue, you may press * and 2. Participants are requested to please use handsets while asking a question.

Ladies and gentlemen, we will now wait for a moment while the question queue assembles. Our first question comes from the line of Kunal Dhamesha with Macquarie.

Please go ahead.

Kunal Dhamesha

Hi, good evening and thank you for the opportunity. First question for Richard, if you could share some initial print on Unloxet launch, how has been the doctor's experience with the product and where is the product making its mark on efficacy, safety side?

A related question on that, within the competitive landscape, do you expect one of the competitors to kind of vacate the Part B channel eventually, given their new dosage form? That's the first question.

Richard Ashcroft

Good questions. Thank you.

The receptivity has been very positive. I think you may recall from the last call, we talked about the unique attributes of Unloxet.

What makes the product unique is that it really provides balance of efficacy and tolerability. This patient population tends to be more frail and more prone to adverse events.

If you look at the mechanism of action of Unloxet, it preserves PD-L2 functioning, and that pathway is thought to be the pathway that leads to immune-mediated adverse events. That's what we're hearing back from physicians.

Not only are they seeing the efficacy that they expected, but they also are not seeing immune-mediated adverse events, which we believe is unique about the product. Physicians have been positive.

We've been actively working with integrated health systems, where a lot of these patients are, to make sure that the product is available on their formularies. We have made sure that we're providing adequate training so their nurses know how to administer the product, and patients have the best possible experience.

As for your other question, you would be better off asking our competitors their strategies as it relates to Part B and Part D reimbursement.

Kunal Dhamesha

Sure, thank you for that update. Second one for Kirti sir on the semaglutide launch in India.

I think the data agencies which primarily track the secondary sales data, where our market share at this point in time are not in the top three, where we are in antidiabetic, we are in top three, right? In terms of prescription share, how is that market planning for us and where do you see we be in that market let's say from a one year down the line perspective?

Kirti Ganorkar

Sure. I think we launched Noveltrit on 21st March, I would say what reflection you are saying both in IMS or IQVIA or even the prescription may not be adequate because any new product when we launch, it takes time for a complete reflection.

Maybe next 5, 6 months, you will see the reflection, which is close to reality. Being said that, the product has been received very well by the doctors community, and one of the differentiating point is our auto-injector as well as the pen system, which was appreciated by the doctors and patient equally well.

Current reflection, what you're saying is right, we are not number one player in the GLP-1 generics, but as I said, the reflection and the reality, it takes some time to reflect. Our endeavor is always to remain leader in the market.

Yeah.

Kunal Dhamesha

Sir, any clarity on will we be there in the oral semaglutide market anytime soon?

Kirti Ganorkar

Sure, sure. For oral, we are completed the clinical study, and once we get approval, we will launch the product at the earliest.

Yeah.

Kunal Dhamesha

Sure, sir. Thank you and all the best.

Kirti Ganorkar

Thank you.

Operator

Thank you. Our next question is from the line of Surya Patra with PhillipCapital.

Please go ahead.

Surya Patra

Thank you for this opportunity, sir. My first question is on the sequential drop in the margin.

Ma'am, in the opening remarks, you mentioned about a couple of cost elements. Am I audible?

Sorry.

Operator

Yeah.

Jayashree Satagopan

Yeah. Please go ahead.

Yeah.

Surya Patra

Sequential dropping the margin, that was my question. How much of this drop is because of let's say Revlimid driven and hence can continue on going ahead?

Jayashree Satagopan

The impact of Revlimid in this is relatively small.

Surya Patra

Okay. Any one-off cost component that is sitting in the other expenses, ma'am?

Can you quantify that? Which may not be recurring?

Jayashree Satagopan

No, there are multiple small items that have together come up to this level. That is why I was also mentioning you should see some amount of normalization as we go forward.

Surya Patra

Okay. Second question is about although we are not discussing Organon acquisition related aspects and I am not asking anything about that, but in what ways See, I think both are equal-sized businesses, if you can give some sense that in what way the base business of Sun Pharma can be complimented.

For example, the cross-selling opportunity, that will be a kind of a common this thing, but apart from that, what other factors or what other complementing aspects that we can see for Sun Pharma's base business because of that integration?

Kirti Ganorkar

Sure, sir. I think this we had done a presentation on Organon, where in a detail I and Jayashree has discussed about how the business complement each other, but I think there are four parts of business where biosimilar is a new addition and the established brand, which is not growing, but which is a 50% of Organon, complements with a branded generic business what we have.

The women's health is a innovative business, which will also add to our innovative business, and our innovative business contribution both combined together goes to 26% to 27%. In my opinion, it's a complementary because very negligible product overlap is there.

Biosimilar is a new addition, yeah. What gets added is a women's health on a innovative side to our existing innovative products in dermatology, ophthalmology, and some part in oncology.

In my opinion, it's quite complementary business, and we are confident that both companies when we close the transaction together, it will help us to grow further.

Surya Patra

Sure, sir. Just last one question, if I may ask.

We have obviously seen a kind of a good progress in Ilumya outside of the U.S., and that is what we have seen the trend also for the global sales business. Can you provide some incremental outlook for the global innovative business outside of U.S., and which other products possibly can see a commercial launches outside of the U.S.

from the innovative basket?

Kirti Ganorkar

Sure. Yeah.

Right. Yeah.

Means we have Ilumya and Odomzo, these are two product outside the U.S. If you remember a couple of quarter back, I said Ilumya, we launch in 35 countries.

Now it has gone to 40 countries, and it is helping us to grow. At the same time, even the other non-Ilumya portfolio is also continuing to grow, and we see that they are adding to the overall growth of the market ex-U.S.

Overall, I would say the innovative medicine part of the business, either you look at U.S. or ex-U.S., it is helping us to grow further.

Surya Patra

Sure, sir. Yeah.

Thank you. Wish you all the best.

Kirti Ganorkar

Thank you.

Operator

Thank you. Ladies and gentlemen, to ask a question, you may please press * and 1.

Our next question is from the line of Neha from Bank of America. Please go ahead.

Neha Manpuria

Thanks for taking my question. Rick, a quick question on the US specialty business.

Would it be fair to assume that the growth that you are seeing in specialty in the U.S. so far, or let's say in FY26, is largely driven by Ilumya?

My second part to the question is as we think about '27-'28, do you think that the Ilumya growth, given the base, sort of slows and you see a much larger growth from newer launches, particularly Leqselvi and Unloxet?

Richard Ashcroft

Thank you for the question. For '26, we did see good growth for Ilumya, but we really saw good growth across our innovative medicines portfolio, it really wasn't singled out just to one brand.

Certainly, if we look at this current fiscal year or the one we're coming into, we expect to see continued growth from Ilumya. We still see good growth of the IL-23 market.

As Kirti mentioned earlier, we also have submitted for a new extension in psoriatic arthritis. Yes, we also expect to see growth from the new brands, Leqselvi and Unloxet, as well as the existing innovative medicines portfolio.

Neha Manpuria

Out of the existing portfolio, excluding Leqselvi, let's say Winlevi particularly, we changed our strategy there, the prescription data seems to be showing a very good traction. How much more room do you think that has with this change in strategy, or this is just the beginning and you think there could be a much steeper improvement in Winlevi as we go through the next two years?

Richard Ashcroft

We continue to see growth based on the model that we've adopted, and we also continue to see good growth of Cequa, a product that you didn't mention, where we think that will continue for the next years as well.

Neha Manpuria

Okay. Last on Leqselvi, how are you thinking about, based on your conversation with formulary partners, is market formation becoming a little more easier?

How do you think we should think about this product, ramp-up of this product, given what we're seeing on the competitive landscape, with one of our competitors sort of slowing down on promotion, a likely new competitor coming in?

Richard Ashcroft

I think there are a couple things in that question. We have continued to improve our access position.

As of April 1st, we have a majority of access now in the US market. We've continued to expand our testing regimens, so that is another plus.

Then I think you're probably referring to a new competitor that may launch. I think, look, anytime there's competition, it's a good thing for patients to have choices.

We know that, even with the best products, there's still patients that don't respond. By having another competitor, we do believe that will help grow the market and that will not only create opportunities for patients, but it will create opportunities for us as well.

Neha Manpuria

Understood. That's very helpful.

If one other question, if I may. If I look at the emerging market business, obviously there's currency tailwind there.

Do you think Sema could be a big driver for emerging market growth for Sun Pharma in '27-'28? We haven't talked about too much information there, but just qualitatively, do you think that could be a big driver either this year or next year?

Aalok Shanghvi

Yeah. I think we will certainly look at maximizing the potential, but we will not be able to provide any guidance.

Neha Manpuria

Understood. Thank you so much.

Operator

Thank you. Participants who wish to ask questions may press * and 1.

Our next question comes from the line of Girish Bakhru with OrbiMed. Please go ahead.

Girish Bakhru

Hi. Thanks for taking my question.

Just some commentary on biosimilar Stelara impact. I know it's in a different channel, but discounts are very heavy, almost going to 90%.

There have been significant formulary exclusion of branded Stelara. Has that changed anything for you for Ilumya in terms of formulary positioning and general commentary on the market share that biosimilar might be taking?

Richard Ashcroft

We are seeing some impact of biosimilars changing formulary access, but we've not seen an impact on our business. Keep in mind that Medicare is one of the primary channels through Part B that Ilumya is reimbursed by, and that has no effect on the Part B reimbursement program.

Girish Bakhru

Is it? There is no cross-referencing of pricing?

Let's say, does it not change gross-to-net for you in case a cheaper option is available in the other channel? Would Part B not negotiate on that front?

Richard Ashcroft

It does not. Part B drugs are not negotiated under that regimen.

Girish Bakhru

Understood. Second one on Unloxet, I know it's still early, but can you share how many accounts have you got onboarded, given this is IV product?

I'm understanding it's positioning will be very different from how Leqselvi will be marketed.

Richard Ashcroft

Now thank you for the question. You're right, the key focus for Unloxet is continuing to work with not just infusion centers, but the academic centers, as well as the integrated health delivery systems.

We're not providing guidance on specifically what number of accounts have or haven't signed contracts, but we are seeing good uptake, particularly with cancer centers, and we are seeing repeat purchases from those centers as well.

Girish Bakhru

Just a ballpark, would you be able to tell how many key priority accounts are there? How many would you target, because last call you mentioned you will only look for new patients.

Is it something that you would go only with a limited distribution or would you actually compare it with other peers what they are doing?

Richard Ashcroft

No, it's not. We don't have a limited distribution model because this product is largely used in institutions, some in the community.

We have wide access available to any academic or any institution, for that matter, that wants to use the product.

Girish Bakhru

Thank you.

Richard Ashcroft

No restrictions.

Operator

Thank you. Our next question comes from the line of Abdulkader Puranwala with ICICI Securities.

Please go ahead.

Abdulkader Puranwala

Hi, sir. Thank you for the opportunity.

My first question is with regards to your specialty products under development and specifically to MM-II. Where we had now planning for a partnership, exactly if you could highlight which markets are we looking for this partnership and in terms of the front end, what is the kind of field force which would be required for this particular drug with the partner or in select markets like U.S.

and Europe?

Dilip Shanghvi

I think we have stated this for US market, we are looking for a partner for developing MM-II further, yeah.

Abdulkader Puranwala

Okay. Sir, would it be fair to assume that the same would happen for the type 2 diabetes drug as well once you complete the phase 2?

Dilip Shanghvi

I think the idea is that in larger market where we will require a large field force to promote, we would look for a partner. In some of the emerging markets and in other geographies, we would look at marketing the product ourselves.

Abdulkader Puranwala

Got it, sir. Thank you.

Operator

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

Please go ahead.

Tushar Manudhane

Thanks for the opportunity. Dilip sir, would like to ask you on this generics business.

While there's a great franchise that has built on the innovative medicine portfolio and the R&D scope has been pretty strong, but somewhere generics business sort of struggle to grow. Just would like to understand what has been the major reasons for this Is it the compliance?

Because the R&D has been pretty strong and that could have also led to a generic pipeline while allocating whatever money for the innovative medicines. If you could just highlight what's happening with the generics business.

Dilip Shanghvi

No, I think part of the question you answered yourself is that because of the compliance issue, we haven't been getting approval. As all of you are aware, generics business is a business where pricing pressure will mean existing product will lose top line every year.

I think as we start getting new approval, hopefully we will start seeing some improvement. I think the sales that you see as a growth in emerging markets, also in India, as well as rest of the world, also are developed by the same R&D team.

We're seeing decent return on investment in terms of the R&D spend.

Tushar Manudhane

Is there any thinking in terms of while maybe the existing site compliance issue are probably taking some more time or longer time, we sort of build new facility with let's say the latest equipment so that the compliance issues are behind and hence we have a renewed look at the generics business?

Dilip Shanghvi

I think like we've shared in the past, I think we continue to work on training and upgrading the existing manpower and ensuring that we're at a minimum meeting or exceeding the requirements from a cGMP perspective. I think the greenfield facility is to address what we foresee as the future requirement to continue to be able to support the business across the world.

Tushar Manudhane

Are we in the process of setting up greenfield for US generics in specific is what I was trying to ask?

Dilip Shanghvi

US generic would be a part of the volume that would be manufactured, but it would not be the stand-alone trigger for the greenfield facility.

Tushar Manudhane

Okay. All right, sir.

Aalok Shanghvi

Tushar, we are referring to the Madhya Pradesh plant that is coming up.

Tushar Manudhane

Yeah. Just conceptually so I'm just trying to think through that while the compliance issue has sort of impacted our business for a pretty long period of time, but I just wanted to understand whether is the generics outlook promising enough that we can look for a newer facility so that we have a compliance in place and hence the growth prospects remains strong or are we sort of questioning the generics industry prospects?

Dilip Shanghvi

No, we are not changing our view on attractiveness of generic business. The new facility is not only for compliance, I think it's also to ensure that we have new supply capacity as our volume continues to expand year after year.

As what Aalok indicated, I think it's a facility being set up for supplying to major global geographies.

Tushar Manudhane

Sure, sir. That's helpful.

Just one more if I may. This facility, sorry for my ignorance, would have what kind of dosages in terms of oral solids, injectables?

Dilip Shanghvi

This is a sterile-only facility.

Tushar Manudhane

Got it, sir. Thanks a lot.

Operator

Thank you. The next question is from the line of Kunal Dhamesha with Macquarie.

Please go ahead.

Kunal Dhamesha

Hi, thank you for the follow-up. One for Dilipbhai on the R&D front.

We have guided for 6% to 7% as percentage of revenue. In terms of the broader split between the innovation and the generic spending, should we assume it in line with the historical track record of 40-60?

Dilip Shanghvi

I think you must have seen that both the last quarter overall R&D spend has grown over the rest of the year, and also the overall percentage of money spent on innovative R&D is also gone up. My expectation is that this will continue to be this.

I can't specifically give you a response as to whether it will be 40-60, 45 what you call 55, or maybe different. As more and more products get into our development pipeline, the innovative R&D spend will go up.

Kunal Dhamesha

Let's put it this way, the percentage spent on or the money spent on innovation divided by innovation revenue, that proportion for the last couple of years has gone down. Right?

Is there a strategic emphasis that we want to reinvest from certain broad range of percentage of revenue from the innovation business into innovation, especially in our existing molecule or is it more of a function of whatever trial comes in or there is a broader strategic emphasis that at least X percentage we want to use? No,

Dilip Shanghvi

I think we have an active lifecycle management approach for all our innovative products, and sometimes the investment versus return looking at the residual IP rights on the product make it difficult for us to commit large sums because we would have relatively low residual IP period. I think the idea for us is to accelerate our capability to identify and initiate the lifecycle management programs faster.

Kunal Dhamesha

Sure. Thank you for that.

One for Jayashree ma'am on the intangible asset increase. I think is it related to the commercialization of the two molecules and hence has it increased, or how to think about that, or is there some milestone payment which we have capitalized?

Jayashree Satagopan

You're right. This is relating to the commercialization of these two molecules.

Kunal Dhamesha

Let's say work-in-progress intangible has been classified as the intangible asset? Is it the correct way to understand?

Dilip Shanghvi

For Leqselvi, yes. For Checkpoint, yeah, it was never under CWIP.

Kunal Dhamesha

Okay. Sure.

Thank you and all the best.

Dilip Shanghvi

Thank you.

Operator

Thank you. The next question is from the line of Vishal Manchanda with Systematix Group.

Please go ahead.

Vishal Manchanda

Hi, good evening, everyone. In FY20 in FY27, I think we don't have a large specialty launch, is it fair to expect that the operating cost growth will moderate in the current year and we should see operating leverage kicking in?

Richard Ashcroft

I think it's important to sustain launches as well, you should expect that we will continue to be investing in Leqselvi and Unloxet going forward. It will become part of our base spend, and that's already been factored into our guidance."

Vishal Manchanda

Any timelines with respect to how should we see this launches happening in Europe and other markets, Unloxet and Leqselvi?

Dilip Shanghvi

I think we're not factoring any sales out of this product in any geographies other than the U.S. this year.

If there is, we will guide both for filing as well as approval.

Vishal Manchanda

Is it these markets are not large enough, or will we need to do additional trials here and we are probably thinking about it? No,

Dilip Shanghvi

I think sometimes the filing itself requires a certain time because you've to recognize that these are products that we license from somebody, and they only wanted to file the product in the U.S. It requires adopting the existing data to recalibrate for different geography, it takes certain amount of time.

We're not taking a view that the other geographies are not attractive.

Vishal Manchanda

Because

Dilip Shanghvi

if you see competing products, they do quite well in other geographies also.

Vishal Manchanda

Understood. Just on the generic business, do we expect any reinspections maybe at Baska or Halol this year?

Aalok Shanghvi

I think the sites operate from a 24/7 audit readiness. I think we would not be able to predict as to when the FDA would audit our sites.

Vishal Manchanda

Okay. Okay.

I have one more question on Winlevi. The innovator company has done a trial on androgenic alopecia, and they have got positive data.

Would Sun have any right of first refusal here?

Aalok Shanghvi

Since this is a pipeline question, we won't be able to answer it.

Vishal Manchanda

Thank you.

Operator

Thank you. The next question is from the line of Shashank Krishnakumar from MK Global.

Please go ahead.

Shashank Krishnakumar

Hi, thanks for taking my question. Just wanted to check on Leqselvi.

I think one of our competitors is likely to get an approval in Europe for adolescents. Just wanted to check where we are in terms of targeting that patient group.

If I'm not wrong, I think we're still in phase 3 for adolescents, just wanted to check. A related question is on Levulan.

I think there again, I think one of our competitors has filed for the sBCC indication. Are there any plans to sort of also try and target that indication with Levulan?

Richard Ashcroft

We do have an active phase 3 trial underway for Leqselvi in adolescents, you're correct. Yes, along with the rest of the portfolio, with Levulan, we're actively looking at a number of different potential LCM opportunities.

Shashank Krishnakumar

That's helpful. Just one clarification.

I think in our opening remarks, we mentioned that this quarter there was higher spending in the U.S. which should sort of normalize.

Was this largely launch-related spend in the U.S.?

Jayashree Satagopan

Let me clarify. The higher spend was on account of several factors in various geographies, including the U.S., it is not only in the U.S.

Shashank Krishnakumar

Got. Thanks.

That's it from me.

Jayashree Satagopan

Thank you.

Operator

Thank you. The next question is from the line of Saion Mukherjee with Nomura.

Please go ahead.

Saion Mukherjee

Thanks for taking my question. I think last year you guided for around $100 $100 million spend on new product launches, initial promotional spend.

Have we spent that amount? Was it more or less?

How much was the spend last year if you can and how should we think about that going forward?

Richard Ashcroft

I think it was around that amount. We're not providing exactly what it is, but it was within that range.

You should anticipate that that just becomes part of our base spend in support of these brands versus a one-off spend. In order to stay competitive, we need to continue to invest in sales force and marketing, medical affairs activities, patient support activities.

In fact, some of those grow as you have more patients.

Saion Mukherjee

Right. My second question is related to tariffs.

I think in April after Section 232 investigation, there was announcement of tariffs on branded innovation drugs. Have you made an assessment of whether it impacts Sun in any way, if you would like to quantify or give some color around it?

Richard Ashcroft

The President did announce in April the resolution of the 232 investigation, laid out a timeline for when those tariffs would apply. I think they're two days, one in July and one in September.

As you would expect, we're looking at all of the available alternatives and we'll look to mitigate accordingly.

Saion Mukherjee

Do you expect any negative impact because of that?

Richard Ashcroft

Marginal impact. Okay.

Saion Mukherjee

Thank you.

Operator

Thank you. Participants to ask a question, you may press * and 1.

Our next question is from the line of Damayanti Kerai with HSBC. Please go ahead.

Damayanti Kerai

Hi, thank you for the opportunity. My question is regarding your EBITDA margin trajectory.

You mentioned you will continue to invest in the new launches of Leqselvi and Unloxet in the U.S., etc., and you have given R&D guidance. Moving from this fourth quarter base, how should we assume EBITDA margins to move ahead, directionally?

Jayashree Satagopan

As we do not guide on the margins. However, the expenses relating to Unloxet and Leqselvi has been factored in the plan for the year.

Damayanti Kerai

That will be ongoing expense for you?

Jayashree Satagopan

Yeah.

Dilip Shanghvi

Just to clarify, Damayanti, we are not guiding whether they will be lower, same, or higher versus last year. That's what we're trying to say, that last year we provided an explicit guidance, this year we are not providing an explicit guidance.

Damayanti Kerai

Sure. Can you indicate your effective tax rate for next year or and beyond?

Jayashree Satagopan

We expect the effective tax rate to be in the range of 25%.

Damayanti Kerai

25%. That's helpful.

Thank you.

Operator

Thank you. Ladies and gentlemen, we have no further questions.

I would now like to hand the conference over to the management for closing comments.

Abhishek Sharma

Thank you, ladies and gentlemen. If you have any questions that have remained unanswered today, you can reach out to the investor relations team.

A very good evening and a happy weekend to all of you. Thank you.

Kirti Ganorkar

Thank you.

Jayashree Satagopan

Thank you.

Operator

On behalf of Sun Pharma, that concludes this conference. Thank you all for joining us.

You may now disconnect your lines.