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Did management answer the analysts?
Every material analyst question, graded on whether management actually answered it — with the verbatim exchange and quantitative claims checked against filed numbers.
Timeline and margin impact of Nestlé JV, and whether it is above India growth guidance.
Asked by Neha Manpuria, Bank of America
Management gave clear timeline and confirmed it is above existing India growth guidance.
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My first question is on the Nestlé JV that we announced last month. If you could give us some color on, you know, when we should start, you know, looking at probably rollout of these brands and, you know, how should we think about ramp up of the entire JV revenue flowing through?
So yes, it's going to be above that, and at the same time, it will take time to bring the brands... Likely that in the first three years it will be some level of investment... It will be post FY 2026, likely, even, post FY 2027.
When complex products and biosimilars will contribute to earnings, and R&D guidance.
Asked by Neha Manpuria, Bank of America
Provided specific timelines for pipeline contributions and R&D spend guidance.
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When can we start seeing the complex product pipeline that we are talking about, or the biosimilars, you know, contribute to earnings, particularly in the U.S. market? And the guidance for next year for R&D, please.
In terms of contribution to the growth, the small molecules, we will see that already in FY 2025... In terms of the biosimilars... likely that in FY 2027, we will start to see the products, coming. The level of, R&D for next year will be, around 8.5%-9%.
Whether base business erosion includes generic Revlimid contribution.
Asked by Kunal Dhamesha, Macquarie Capital
Avoided confirming if Revlimid is part of base business erosion.
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North America, we have said that, the quarter-on-quarter decline is due to erosion in, base business. So my question is, would this base business terminology include revenue from generic Revlimid?
The quarter obviously include the sales of linaclotide. The decline is a combination of a sequence of service. So it's not a market share loss, it's more of a sequence of supply, as well as certain price erosion that was on the base business, unrelated to linaclotide.
Whether U.S. price erosion trend has accelerated recently.
Asked by Kunal Dhamesha, Macquarie Capital
Acknowledged price erosion on some products but did not quantify acceleration.
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In terms of the U.S. price erosion, while it continues, have you seen any change in the recent trend, where it is again accelerating at a higher pace, you know, in recent months?
So the overall sentiment is unchanged. Still, the lion's share of the interest, I think, is sustainability of service and supply... At the same time, we did face competition in some of our big products, and those products we did see price erosion.
Breakdown of R&D spend increase across biosimilars, NCE, and generics.
Asked by Saion Mukherjee, Nomura
Provided percentage breakdown of R&D spend by category.
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We have seen a significant step-up, and as you mentioned, your guidance, it looks like you're talking about more than $300 million of R&D spend next year. You know, if you can provide, like, where this money is being spent in terms of biosimilars or NCE research and other generic activity?
So the R&D is spent, obviously on the small molecules as well as the big molecules. I think the main contribution to the growth is the timing of the clinical trial of the biosimilar, which is about 20% of the R&D spend. So if you wish, between the small molecules and the big molecules, so you have about 60% that goes to the small molecules, about 20% that is going to the biosimilars, and the 20% that goes to either API or other initiatives.
Growth outlook for emerging markets, especially China and Brazil.
Asked by Saion Mukherjee, Nomura
Provided double-digit growth expectation and specific China product submission numbers.
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How do you see the growth in emerging markets in the years ahead, particularly with respect to China and, you know, some of the key markets like Brazil, if you can talk about your outlook for 2025 and 2026?
So it will continue to grow. It will continue to grow in double digits. China looks good, we are now consistently submitting 14, 15 products a year. So this likely to continue. And also, we got some interesting approvals. So overall, in constant currency, I believe that we are in a good shape.
Details on four new U.S. launches and CRL for biosimilar Rituximab.
Asked by Balaji Prasad (Michaela), Barclays
Gave timeline for CRL response but no specifics on launches.
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We see you launched four new products in the U.S. during the quarter. Could you just provide a little bit more detail on these launches? My second question is if you could provide a bit more detail on the CRL issued to the BLA for biosimilar Rituximab. What are the next steps here, and what does this entail?
On the launches this quarter, as I mentioned, we launched five products during the quarter. We kind of mentioned the names along the way. We will try to provide it to you in a second. As for the CRL, we got certain questions primarily about the CMC of the product, and we are planning to address that around the September timeframe.
Breakdown of INR 2,700 crore CapEx, cumulative biosimilar investment, and biosimilar business update.
Asked by Tarang Agrawal, Old Bridge
Provided percentage split but not detailed project-level breakdown.
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Capital expenditures stepped up quite a lot in both FY 2023, FY 2024. If I look at 2024 alone, roughly, INR 2,700 crores of CapEx. You know, so if you could just give us a sense in terms of, a broad, set of baskets where this INR 2,700 crore would have been deployed.
About CapEx, first of all, and most of our CapEx is going toward expansion. Let's say give or take, around 75% of it is going to expansions. And normally, the other is going what we call maintenance... Also, for next year, we are investing primarily the CapEx in products that we want to launch and with that capacity, both in the API as well as in our injectable facilities.
Cumulative spend on biosimilars and whether $50-60 million per annum is reasonable.
Asked by Tarang Agrawal, Old Bridge
Did not give cumulative spend, only confirmed annual loss estimate.
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If you could give us an update on your biosimilar business from your own, and what have your cumulative spends been on this business till March 2024?
What you can assume, and I mentioned it before, that if 20% is going to the R&D, this is give or take also at the level of loss that we have in a year... Yeah, in the ballpark, yeah.
Percentage of India manufacturing in-house vs outsourced and supplier base fragmentation.
Asked by Nitesh Dutt, Burman Capital
Provided in-house percentage but not supplier count or future mix details.
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What percentage of your manufacturing in India is being done in-house, versus outsourced, and are you expecting to maintain a similar mix going forward? And for the outsourcing part, how many suppliers do we typically have?
So right now, about 60% of what we do is in-house, and likely that these numbers will increase in the future because we did, we do, have localizations of, of some of these products, in the future. As for the numbers of partners, I don't recall the exact number, but I'm assuming that it's in double digits.
Pricing trend and sustainability for generic Revlimid.
Asked by Surya Patra, PhillipCapital
Explicitly declined to answer due to confidentiality.
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My first question is on the pricing trend that you've been seeing for Revlimid. So, and how sustainable the pricing trend currently that we are having for that? Because there are multiple rounds of new player entry that we have seen, so whether that has impacted the realization potential of the product in the recent period?
So I'm not going to discuss quantities or prices of this product, as you know. I just said, I'm not going to discuss pricing or quantities of this product. We need to remain confidential to our agreements. And what we can say is that it's going to stay meaningful product for us throughout the period of Revlimid.
Revenue mix target for domestic formulation business over three years.
Asked by Surya Patra, PhillipCapital
Provided a specific revenue target for FY 2030.
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If you can give something, let's say, over a period of three years from now, what is the share of revenue mix that you should be seeing for your domestic formulation business?
The expectation of both businesses, if you ask about the long term, is to be top five in India. If you want an assumption, it's in the neighborhood of around INR 12,000 crore, somewhere in FY 2030. But this is obviously a neighborhood that we are striving to be.