FY26 closed at 29.7% EBITDA vs Q1 24-25% guide.

My second question is on, one of the growth levers that you spoke about was, focus on the novel drugs. With the MFN policy now, how should we look at that strategy going ahead? The second part is on the tariff side. We do have two facilities in the US, and you also in your opening remarks alluded towards, if there were enough incentives, you would look at setting up more facilities. What kind of flexibility first of all, the 2 facilities offer us in terms of like managing supply chain on some of our key products and if you can talk a little bit about, how are we looking at setting up any new facilities if possible?

I think the MFN would definitely impact the brand side of the business much more than the generic and the focus under IRA has been on the highest value drugs. So, it is really the highest value drugs that will likely get impacted. I think that at the end of the day the value of the brand has an impact on the opportunity for generic. So, obviously we track it very carefully. We don't see a direct impact on our brand products which are relatively speaking small in the scheme of things. I also think that the MFN order would be challenged like it was in the last time Trump was in the office. As far as tariffs go and our flexibility what we are willing to do in the US , my first hope is that the bilateral trade negotiation is successful. Having said that given the flexibility that we have with Coral Springs as well as Somerset, if there is a need to manufacture essential drugs in the US , we will explore it. We are actively exploring that with the National Security Council as part of the White House right now. The government has identified 9 drugs that they believe that are essential and we go into the dialogue back and forth with them to determine how we can build the partnership between India and the US to give them the confidence that they will have reliability of supply.

The House of Representatives of US is trying to cut the cost of Medicaid by USD 880 billion dollars to fund the gap in tax. So, just wondering how could it affect the Indian hemisphere if it does get through?

I think a big part of CMS spending is on branded drugs, so I think the first impact you would see is on branded drugs. And that's what they are trying to do with this MFN clause, to negotiate pricing on brand drugs at a level similar to Europe. I don't expect it to get to generic drugs very quickly because , generic drugs are already a pretty low spend. We have emphasized to the government as part of the Section 232 investigation in the commerce department that there's a lot of inefficiency in the supply chain. When you look at the generic side of the industry there is only a small percentage of the value that comes to the manufacturer, there's a big part that goes into the GPOs and PBMs and that's where they need to focus to be able to gain efficiency. So, we think that the PBMs are going to be challenged quite a bit. And I see limited impact on generics.

On the India piece, how do you see insulin acquisition of the Lily drug playing up with Semaglutide when it goes off-patent in India? Comments on that, how do you think you are going to play that?

So as far as the Lily acquisition is concerned our objective was to acquire Huminsulin so we can penetrate into Tier-2 Tier-3 markets also and we can capture that market of insulin there. Now, Novo going out as far as insulin market is concerned particularly cartridges, we expect that we will be able to garner that market share also which will be vacated by them. At present our Huminsulin market share is 18%. We expect with this space becoming available we will be able to garner another 6 -7% market share as far as Huminsulin is concerned. Semaglutide going off -patent as Vinita also mentioned in March 2026, we are developing in-house also Semaglutide and we have partnered with other partners also so we are very much ready once it goes LOE. And we expect that this market is going to go up because once the prices come down the usage is going to go up.

Last one on Mirabegron where do we stand, what is our stand on that right now?

We continue to sell the product - no change. And we have the trial in February, and believe that we have plenty of defences that, you know we have a good chance to fight at that point in time. So, we will find out in February.

Does it look that your first half will be much bigger than the second half?

So, for the company it looks like both first half second half would be great. For the US, first half certainly has a lot more of Tolvaptan than the second half does. But in the second half we have injectables coming in, in particular the three I mentioned , Glucagon, Liraglutide and Risperidone all come into the tail end of the first half so really have a strong contribution in the second half. We certainly have the US more front loaded in the year.

Second question is on injectable launches which you just mentioned. So, in terms of your application what is the current visibility? Are you confident about timely launches?

So we think that majority of these products we have heard recently about Glucagon, we have heard recently about Victoza. It is between July and August that we should get approval. We haven't heard any different on Risperidone, in the next couple of months we should get that approved as well.

Second question is about the margin for the quarter that you mentioned, Ramesh sir, that after adjustments it is something like 26% kind of a margin profile for the core business for the quarter. And there are adjacencies also which are currently having negative impact to the overall FY25 margin. So, two things - what would have surprised this 26% kind of core EBITDA margin for the quarter. And is it Mirabegron only driving that, you can clarify that. Secondly, the impact of the adjacencies if you can quantify that for FY25?

In terms of adjacencies, this is essentially the digital business, the diagnostics, API CDMO, the bio business, all of these are still evolving. So, if we were to knock out that impact it will be about 3.5 to 3.7 percentage points. And in terms of the first part of the question, we lost out in terms of PLI - not lost out it was actually capping out because there is a limit to what we can claim for any year. So, previous quarter was higher by about INR 50 crores. This quarter that's the impact it is about 1% lower because of that and the higher impact in terms of R&D I will specify that again, the R&D spends are lot higher. If we knock out that impact, then potentially that 23.2% would have been 26%.

There is more than 20% CAGR growth on the R&D spend over the last 3 to 4 years that we have seen. And obviously there are some results that we are witnessing now on the market. Going ahead what would be your plan in terms of the spend quantum, in terms of percentage or in terms of growth?

Our R&D spend would go up next year . I expect at least about 10 % to 15% growth out there. Principally because of the kind of products that we are working on. There is a slant towards more complex stuff. That will bring in a lot of more expenditure as well. If we take count actually close to about 70%-72% of our spends today is really on complex stuff. This includes biosimilars, the inhalation portfolio, the complex injectables, the 505(b)(2)s, all of this, and in some parts the specialty as well. So, that calls for a lot of expenses. Therefore, the ab solute numbers are set to go up. And as a percentage of sales also so it is about 8% right now. So, I believe that will be upward of 8.5% next year.

Just one last clarification, ma'am, from your side. Any competition for Spiriva one should think about?

There are one or two filers that have filed already. But just given how long it took for us to get approval - it took 5 years for us to get approval. Now the FDA would have gained a lot through the interaction back and forth. I think for the next 12 months we should still be the sole generic in the market place.

Vinita, should we expect Spiriva Respimat launch in FY27?

No, it actually was one of the FY29 DPI products.

I don't quite understand your biosimilar strategy so when I look at your pipeline. Most of your products are coming maybe 4 or 5 years after the first entrant. So, I don't know, is it more opportunistic because the regulatory barriers seem to be lower now. Just a thought process behind it?

It has been quite an evolution. The strategy has been evolving on the biosimilars front just given the market evolution. When you look at the changes that have taken place in the US. It is really creating opportunity for older products as well for us. For example, Pegfilgrastim it's a very old product, multiple players in the marketplace. But as we have had conversations over the last year with the customer base the fact that we will come in with a new ASP that's attractive for providers makes it a very attractive opportunity. So, we really see value in bringing Pegfilgrastim to market. In the US we have the ability to bring the product into the market ourselves in s fiscal year 30. It will be a material opportunity for us because we likely will still be one of four in the marketplace. Having said that going forward now given the barriers are reducing it becomes like a complex generic play for us. So, the focus is on products where the number of competitors are limited or where we can be one of few in the market place.

Vinita, on your foray into specialty. One, what are the therapy areas that we are looking at this time, is it different from what we were looking at previously which was women's health. Second, you know from a P&L as well as balance sheet investment when does the P&L investment kick in, how much are we thinking we want to invest, given the pipeline that you have. And from balance sheet what's the number that you are looking at committing for M&A or asset acquisition for specialty?

So, on the areas of focus, they are very much Respiratory and CNS. In respiratory given that we have Xopenex, we have a position in respiratory already. We can bring synergies through our development lifecycle management within our internal capabilities. So, respiratory definitely is a big focus, building on what we have. And CNS neurology - with NaMuscla, we are now doing the study to bring the product to US as well, that's multiple times the opportunity of the current product. If we can get other neurology products, they will be synergistic with the infrastructure that we have in Europe as well as what we will build in the US. Those are still the two focus areas. Opportunistically we look at other areas as well based on the assets that come to market. Our focus is very much on accretive assets; on a limited basis we are looking at pipeline assets. On the pipeline front we obviously want de -risked pipelines , so late-stage programs and will want to look at creative structures around it to be able to mitigate the risk on our P&L.

Nilesh, last one for you. For the India business you know you talked about double digit growth for next year. Given Empagliflozin, just went generic we have that impact, we had a large tender number in the base. Despite of that we would be able to grow double digit, would that be a fair conclusion, and what would be driving that growth. Is it new product launches? You mentioned about 400-500 MR additions, are there new divisions that you are launching, just some colour there?

I think we are really coming into our own in some of these therapy areas. We have had all of the disruptions on the cardiovascular side. So, that's all played out and the like. So, now we are seeing that 30% ahead of market growth. We see diabetes obviously with this happening, but we will still see good volume growth and I think we will still grow at a double digit in diabetes as well. Respiratory has been slow in the last couple of years. We have launched a new task force for nebulization, we have expanded our Uday Division which is focused on extra urban as well. That will lead to growth again as well. So, sum of it all I think we are going to grow at double digit and not just for the next year. I think the intent is to grow at 20-30% ahead of the market, I believe the market will grow at 6 -7% or 8% as the case maybe. On top of that if you grow at 20-30% ahead you will be at that double digit.

The first question is on Tolvaptan. I think our understanding was that this is going to be a long tail product for us. Has there been any change in that view that we had on this product?

No, we always said that in the 6-month exclusivity we will gain a lot more than the period where we have additional competition. But given the launch efforts and what we have learnt in the last couple of months, the specialty distributors and that market works a little bit differently. They really like to establish longer term relationships. So, for REMS product we expected in any case the tail to be longer and now with the relationships that we have established with the specialty distributors we feel even stronger that we should be able to maintain a high share in the time when others get in.