Have we made the filings in Brazil for Semaglutide and do we expect to be there on day one?
No, I prefer not commenting about individual product strategies. Actually, the approval for this product would not be so straightforward. So, it's hard to predict as to when we would be on the market. So, I would refrain from making predictions about Torrent and about our peers.
And oral also you expect to launch in March next year or it will be sometime later?
The exact date is not certain, but it would most likely be in the first wave of any generic launch.
On EBITDA margin guidance for FY26?
And, Damayanti, on the margin story, I think we will wait for Quarter 1 and then probably directionally we can guide you.
On the U.S. business, Sanjay, you mentioned that the growth so far has come from volume growth in existing contracts. When should we start seeing traction in new launches now that the facility is cleared and should we assume a step up in U.S. in '26?
So, I think it will be, you know, we have launches from the product that we had filed a few years ago. So, there would be, let's say, close to 5 to 10 launches each year. But the value of those launches is a little bit not so high because of the delay that we have had in getting approvals for these ANDAs. But as we ramp up launches of new ANDAs, which were filed in the last two years, you would see that. So, I would expect not much impact this year, more impact next year and even higher impact in the year afterwards.
Usually we have mentioned that we should be able to grow margins by 75 to 100 basis points historically. Any reason for reserving the guidance this time around?
No, I mean, nothing of that sort, Neha. Usually, end of Quarter 4, I try and avoid giving any guidance and then based on Quarter 1 results, it's more clearer where we are heading for. But you are right actually, given the branded business contribution which we have and that two or three levers playing out every year for us, there needs to be an improvement coming in. The only additionally thing I would like to guide you is that there is some increase which we believe will happen on the R&D side, not significant, but against 5 maybe moving towards 5.4 kind of a number. So, that's something additionally which will play out next year, and therefore my comment, that let's wait for Quarter 1 so that directionally I can tell you for the full year what kind of EBITDA margin improvement can happen.
On Sema partnership - multiple suppliers or limited suppliers?
So, the best way to judge this is by looking at how many companies are working on the clinical trial of the product, which is publicly available information. Now, judging by that number, it's looking like there will be multiple players coming into the market for sure. It is the question of when their trial is completed and when their entry into the market is approved. So, depending on whoever is the first wave, that could define a lot of the market share trajectory for most of the companies.
As far as Curatio is concerned, this year the growth was 18%-19%. How are margins for this business and do you still expect margins to improve?
Yes, because currently we are still reinvesting in that business. And I would say a reasonable kind of margin is being reinvested in the platform. Maybe next 1-2 years that may be required and then over time it should start tapering down and that's when the margin would further likely expand. It's already come up quite a lot from the pre-acquisition level, but there is certainly a scope to increase significantly from here as well.
On Semaglutide market in Brazil - market size, competition expected, and volumes?
Yes, so currently the product has been in short supply. So, the market size is, it's kind of hard to turn down. It will be north of 500 million. But the exact size is hard to gauge. There would be, I would say, between 5 to 10 filers, but then approvals are not straightforward. So, we have seen that the filers are there even in more advanced markets like the U.S., but the approvals are much lesser. Price erosion will depend upon the number of competitors honestly.
Sudhir, you had earlier pointed out that the insulin CMO sales which we had logged in 2Q and 3Q would get recouped in 4th Quarter. But that doesn't seem to have played out. Do you think that business has got lost?
No, I think there was some amount of destocking which was done by the principal. And therefore, Quarter 4 sales at 75. You are right, I mean, the sales should have been higher. Our expectation is, some catch up would happen in Quarter 1 and Quarter 2, what was not there in Quarter 4. But broadly, I indicated yes. I mean, the same run rate should minimum get maintained for the current year as well. But there should be some catch up which is happening in one quarter.
We are guided to almost Rs. 120 crore of sales getting recouped in Quarter 4. Do you think the same quantum will get recouped in Q1 and Q2?
Rahul, I have actually not taken stock of what's happening for Quarter 1. Maybe once we have Quarter 1, I can give you directionally what kind of incremental sales will happen in insulin business.
On the U.S. business, $130 million revenue annually. I thought we have an imminent launch coming up for Entresto and many other products. So, why the traction comes next year, not this year?
So, Entresto has been an interesting journey, actually. So, basically, we have seen that there has been a kind of delay in the launch of generics on this product. We were anticipating the first generic four-five months ago. And at present, we are anticipating a generic in the course of a quarter, July-August timeframe. And then we expect multiple entrants at the same time or in a short window. So, I don't think the opportunity is as big for the generic industry as it was a few months ago. We have approvals on this product, and now we would be launching as soon as possible and as soon as our settlement agreement allows us in line with the terms in that agreement. But it's going to be a multiplayer opportunity whenever it happens.
We did 1% growth for U.S. this year fiscal '25, what's the likely guidance then for '26?
I mean, my goal right now is to, so, I have a few opportunities to launch products. So, I would say in the coming year, I will expect to launch about between, say, 7-8 products. And some of them, so we just launched that Eslicarbazepine. We just launched Esomeprazole granules. So, we have launched another one which is Diclofenac sachets. So, we are launching. These are smaller products, but I think in the end if we have 7 to 8 launches, it will add up to a meaningful figure which will help us in compensate for the price erosion as well as other things that happen in the U.S. market in terms of share loss or new competitors or things of that sort. So, I would say that for the next 12 months, my goal would be some growth in the right direction without trying to quantify it.
On Brazil Sema - the market is 500 million, do we have a filing and when do we expect market formation?
So, let me clarify. So, the market was about half a billion at the end of 2023. And then at the end of 2024, the Novo Nordisk launched Wegovy and the market was about 880 million reais. I am talking in reais. Currently we expect the market, we don't have data, analyzed data, but I would expect by the end of 2025 the market to be about 1 billion reais. Just extrapolating on the current size and the current trend that I am seeing. We have access to the product and reserve. So, we have signed up with a partner who has the dossier and we would be expecting an approval, but it's highly uncertain. People who have filed long ago in the U.S. or in Brazil have still not received approvals. So, I don't know. It's not a straightforward product which would get approval like on Day 1 of patent expiry. Hence, our reluctance to make predictions on the timing of launch on the way it would go from, but we would be have access to the product. So, my current expectation is wave one. The only thing which I cannot tell you is how wide is the wave. So, technically it starts in 2026, right? And we would expect at least one player.
On the insulin business: can you share the revenues and have you seen improvement in Q4? And in the backdrop of innovator deciding to discontinue sales, how should we think about the impact for fiscal '26, both on top line and margins?
Saion, Quarter 4, we did Rs. 75 crores of insulin business. It should more or less remain at the same level, which is a quarterly run rate of 75. No, it doesn't impact because we manufacture vials for them and they have discontinued pens, I would say.
What about India? Are we ready for day one launch in India?
Yes, India first wave is looking likely at the moment for both the injectable and the oral.
In view of this channel destocking in Brazil, how should we look at the segment growth for FY '26? And what kind of impact can we see on the overall EBITDA margins from currency?
On a like-to-like, on a constant currency basis, we expect the business to grow in double digits. So, in the range of 10% to 12%, a few percentage points higher than the market. So, the last two years, we have seen the market grow at about 9%. So, we expect to be higher than that by 2% to 3% points.
On EBITDA margins for FY26 - should we assume 32% EBITDA margin is something which you will sustain in near term? And can you bifurcate India growth between volume, price and new launches?
So, the breakup of India business, our reported growth is 12% and the reflection in AIOCD for the quarter is 14%. The breakup of that 14% is 4% volume against 0.2% of the market, 7.4% price versus 5.3% price growth of the market and 2.3% new products versus 2.3% of the market new products. In terms of Curatio, I think, yes, the revenue growth has been quite accelerated, I would say, over the last couple of quarters. This full year, I think, the Curatio portfolio has grown around 18% or 19%. It has become, I would say, relatively sizable in the total India business now and we believe that the upcoming year at least our ambition is that the growth should be potentially higher than the previous year as well.
In terms of Semaglutide business prospects, from availability of a product perspective and manufacturing perspective, is supply constrained or are there multiple suppliers available?
No, as far as we are concerned, we have secured supply for the launch. For the injectable, as mentioned, it's a partnered product. And the oral product will be in-house developed where we have adequate capacity. So, we don't see any constraint.
Further addition of MRs in FY '26?
Yes, so we closed this year at 6,400. Additional expansion is already underway. So, maybe by the end of Q1, we should have 200 to 300 more. And potentially for the end of the year we may be between 6,800 to 6,900.
There is this product Eslicarbazepine in the US. I believe you are a first to file exclusivity holder and have a settlement with the innovator. One of your competitors have already launched the product. May I know if you have launched as well?
Yes, we have launched a product and we have north of 20% market share in this product. But the generic pricing on this is not a very attractive price. We launched it on day one, which was in Q4.
I saw that you have taken an enabling resolution for raise of funds. Is that anything particular in mind?
No, there is nothing specific in mind. We do this every year. And this is the practice that we have been continuing, I think, probably since last more than five years, I would say. So, it's only an enabling resolution, nothing specific.
On Brazil, how many MRs or the salesforce do we have at this point of time? Have you increased the number of people on ground in the last few years? And how to look over the next two, three years?
So, we have about 330 MRs in Brazil. And so essentially, we had two teams, one team in Cardio and one team in CNS. And over the last two years, we have added an additional team in CNS. So, now we have two teams doing that. Our plans for the future, right now, we don't have any plans in the short run for this year. And we will see how the business develops, how the new products perform, and then we will take a call.
On MR productivity in Brazil - how far from normalized level?
At present, because of the recent addition of these 120 people, our productivity is below where it was before. So, it's roughly 200,000 BRL per month.
In India, you expect to add around 600 to 700 MRs. Any particular segment or across the board?
No, it will be across a few divisions and maybe two different therapy areas. We are looking at maybe 400 to 500 new MR additions this year.
The comment on R&D spend seems to be up like 20% or so this year. Where are you investing in R&D?
So, there is a few territories which is seeing an increase including India. India, we are adding complex products which require higher investments than the usual approvals that we have seen in the past. So, that's one lever. And a few products in Brazil and some of the other territories.
Bulk of the increase attributed to US in FY '26?
So, it's more branded segments versus U.S., I would say. India, Brazil, mainly. Large part of it, actually.
Which specific therapies have we added MRs in last year?
So, last year, we shared that we had most of the expansion done in the chronic therapies and in sub-chronic which will include gastro. And the upcoming year expansion would be within chronic as well.
On the consumer health segment - how are you thinking about increasing the expense from here based on the traction you are seeing?
Yes, so we have maintained the same number of brands that are on the platform, which right now it's mainly four in a meaningful way. We continue to invest in these four brands. We are seeing pretty good traction across all of them in relation to the spend that is being done. I would say, out of the four, maybe two brands are taking up, say, 60% to 70% actually, and the other two are about 30%. So, overall, relative to the investments being made and the size of the relative brands, they all seem pretty good acceleration. The two main arrowheads being Shelcal and Tedibar. From the previous year's base, it would increase slightly. Not anything major, but there would be say a high single-digit increase.
What are the usages of cash in fiscal '26?
No, so I think the priority is to repay and bring down the debt, right? And which I think maybe by first half of FY '27 or maybe Quarter 3 of FY '27, I should be able to prepay everything and should get into net cash. Rightly for FY '26, the goal is to use whatever cash flows or excess cash which is available to prepay or repay the debt which I have on my balance sheet.