Thank you very much, sir. We will now begin the question-and-answer session. The first question is from Damayanti Kerai.

My first question is on your opening remarks where you mentioned that U.S. sales should be back on growth trajectory starting FY28. So just want to understand, this growth will be on the base of USD 1.1 billion to USD 1.2 billion number, which you mentioned for FY27, or how should we understand this part?

That’s right. Over the FY27 base.

My second question is, if you can update us on some of the key launches or key products in injectables and respiratory space, which will be meaningful from your U.S. sales perspective?

So, there are multiple products in the biosimilars, injectables, and respiratory front over the next couple of years. In FY27 itself, we have yet to launch Pegfilgrastim that is going to be an H2 product for us. We expect it to contribute very nicely into the second half. Then we have a 505(b)(2) Dalbavancin injectable that is going to be a good size product for ourselves as well. And nasal sprays like Fluticasone nasal

spray, as well as injectables, Sugammadex, Epinephrine, Raltegravir, where we have exclusive first-to-file, Eribulin injection, which is all FY27. Then FY28, full-year impact of Pegfilgrastim. We have Diazepam nasal spray, Epinephrine nasal spray, as well as Apixaban 505(b)(2). That is starting to look like a material opportunity for us. We're still sizing it up, but it is looking fairly interesting for us. Then iron sucrose injectable and Saxenda®. We have Ivacaftor exclusive first-to-file, Midazolam nasal spray, and they're just a few of the products. We have other nasal sprays as well as injectables in the pipeline that we'll expect to bring to market in FY28. And then I'd say that in FY29, we should have more biosimilars, Aflibercept, Pegfilgrastim on body injector. Dulera is expected. Hopefully we can get it in FY28, but if not, for certain in FY29 on the market. And depending on what transpires from a P4 standpoint, we would expect Spiriva Respimat ®. We've made good progress on that front; we expect to file it in this fiscal year. We should, subject to what happens with the brand, the P4, we could potentially be in the market on the Respimat front as well in FY29.

Last question is, when you look at the Tiotropium market share, it has been hovering around mid-30s. So, do you have room to improve it further? And if you can talk a bit about your progress in the incremental channels for this product?

It's kind of settled at that 38% level. And there is a good balance between what the brand has in terms of share and what we have in terms of market share. So, at this point, it should hover around that level.

We'll take the next question from Shyam Srinivasan.

Just trying to do math on your U.S. guidance . We did USD 366 million this quarter. You talked about USD 1.1 billion to USD 1.2 billion for the full year. So that brings us like roughly USD 100 million lower per quarter , in some of the quarters, right? So , if I'm doing simple math, then USD 250 million and USD 280 million roughly, right? What is that big step-down? Is it both the top two products that will likely see the step -down, or is there an element of conservatism built into the kind of step -down? Just want to get some qualitative sense of why despite a very strong Q1, how are we looking at it?

In Q1, you don't have any additional competition on Tolvaptan. And from Q2 onwards, you will start seeing the impact of Apotex and Teva. We also expect in September, we could potentially have one more entrant. We expect to be a four-player market with Tolvaptan. And we expect the market to grow as well for the molecule, given that it is still 40% generic conversion so far. But given the additional competition, we expect pricing to come down, and obviously also some share re -distribution. So, we expect Tolvaptan to come down over the next couple of quarters. Mirabegron has already seen pressure in the first quarter, and we expect that to be a full quarter impact from Q2 onwards. We expect revenues to be anywhere between USD 250 million to USD 280 million a quarter over the next couple of quarters.

When I look at your full -year margin guidance of about 25% and we did the gross margins of 75% for the current quarter, right? So, what's a more normalized gross margin, please?

It is really going to be a function of how much of Tolvaptan sales and at what realization, the kind of competition that you see out there. And more importantly, the impact of price increases that we have seen in the recent past; post the cost increase that is because of the geopolitical tensions around. So, the first quarter was not so hugely impacted because of the fact that we had inventories that we carried forward, but going forward, we will have to take that into account. So, I think we are being a little more cautious when you speak about the fact that the EBITDA margins would be in the range of 24% to 25%. And obviously, this would be, as a reduction on the gross margins front as well.

The next question is from Neha Manpuria.

In Tolvaptan, we have seen a QoQ increase in market share. Would that be a fair assumption?

Yes.

I think in one of your previous call, you'd mentioned that despite additional competition coming through, we should be able to defend our market share in Tolvaptan. Do you see that dynamic playing out given that we've been able to gain share over the last few quarters?

Yes. We would expect the market share tail to be longer, because of the fact that it's a specialty pharmacy product as well as our REMS program. But we obviously will have to give some share as well to the additional entrants.

In Apixaban, how should we think about the opportunity? You mentioned you're still sizing it up, but how should we think about the 505(b)(2) launch and our ability to take market share in case we launch it in FY28?

We are looking at the different channels for the product. It's a very large brand, which makes it a very interesting opportunity. But given the time we have, prior to the other generics entering the market in FY29, we believe that a very targeted approach around a few channels is going to serve us well. So, we are looking at ways and means of entering, a few of the larger channels through our national accounts’ efforts, as well as some incremental commercial efforts, to be able to get strong access.

Do you think this should be as large as probably, Mirabegron and Tolvaptan was for us? Could this be as large in your view?

It could potentially get there.

Put together, it's a material opportunity for us. The U.S. itself, of course, we have to deliver this year, but it's looking like a very interesting opportunity with Pegfilgrastim. Ranibizumab, we'll have to convert the market. I mean, the market has gone into the other products. I think a little bit of a smaller opportunity compared to Pegfilgrastim, but Ranibizumab looks like a big opportunity for us in Europe , in a few countries direct and also through our partnerships with Sandoz as well as others. Now, with the VISUfarma footprint that we have across the ophthalmology call point, we're going to leverage that as well for Ranibizumab. And then we have Aflibercept coming in FY29, and the Pegfilgrastim OBI. In FY30, calendar year '29, we have Etanercept. So, I think we are looking at biosimilars ramping up in the next three years to a couple of hundred million dollars scale business across these key markets.

The next question is from Soorya Patra.

My first question is on the respiratory portfolio. How big is the respiratory portfolio contribution to the overall business for Lupin right now? In terms of the U.S. business, what would be its share currently?

In the base business, I'm just going by memory here, it's over 20% right now, Tiotropium, Albuterol as well as Xopenex®. So, a little bit more than 20% even. And as we look at our pipeline, we have Dulera® that is filed. We have multiple products that we are now making progress on like, Respimat, we have made significant progress over the last quarter, and we are in a position to file this fiscal year. We also have been successful with a pivotal PK on B reo®. So very pleased to get the Ellipta franchise also started from a pipeline perspective, and we would expect to file the ANDA later this fiscal year. We have green propellants, the Luforbec ® new propellant filed in Europe in the last quarter in fact, and multiple pipeline programs also making progress for Europe. So really pleased with the progress now that we are making on the respiratory pipeline, with MDIs, DPIs, Respimat, Ellipta, as well as green propellants.

From the Albuterol side, for which the market share, has to some extent subsided from the level of 19% - 20% to 16% currently, and possibly we have already reached the peak potential of Tiotropium. So here, in the mid -term, till the time that the pipeline products are getting launched in the U.S., is it fair to believe that the respiratory portfolio in the U.S. is likely to remain flattish or kind of moderating like that?

This is hard to predict for certain. But right now, the Albuterol market has stabilized. It has the 16% share, and the relative positions of competition are kind of stabilized based on the supply situations from the different competitors. On Tiotropium, we know how difficult it has been for us . We haven't really heard of any imminent approvals and launches. So, we would expect that the baseline should be stable as D ulera®, our nasal spray products in the next year, and then the new products, Respimat, as well as others come to market.

My next question is on the Europe business, which has been doing great for us, and that is visible even in this quarter. But I was just going through the kind of a higher rebate policy initiated by Germany, wherein they are kind of doubling the rebate requirement. What would be your reading about either profitability or pricing pressure what we can see in the European market? Or let's say, if it is Germany, then even if we restrict that policy to Germany, then what implication that the overall Europe portfolio can see because of this?

It's very interesting, the dynamics in all of the European countries that we are realizing. And even in Germany, on the one side, you see the increase in rebate on a part of our portfolio, but in others, for example, in our biosimilars, in particular for Ranibizumab and Aflibercept, we are finding that it's not part of the AOK tenders anymore. So , it becomes a nice, branded opportunity. Overall, we are seeing all the major European markets really struggling with the overall healthcare budgets, the overall drug spends budgets, and they are struggling to really bring more innovative products into the fold and not making enough products available for unmet needs for patients. We are starting to see, like, in countries like France, we have recently noticed that they are really doubling down on biosimilars, just given how important the biologics LOE is . R ight now, it's like USD 100 plus billion worth of biosimilars that go off patent over the next five to 10 years. So , more incentives for substitution of biosimilars that we have seen to be able to reduce some of the drug spend so that they can make room for innovative products. And I think if that model works for France, we will see very soon the other countries following a similar model to be able to afford innovation, while making the generic side and the biosimilar side of the business more substitutable to be able to get efficient access to medicines. We are very optimistic, very hopeful that Europe is going to increasingly become a more important geography for Lupin for certain, just given our portfolio of respiratory products, biosimilars overall, as well as the ophthalmology biosimilars, as well as the specialty portfolio. We have tremendous headroom to be able to build in Europe.

Just last one question from my side regard ing the biosimilars. Two points specifically here. How sizable are these two opportunities, first two product opportunity in the U.S., for us, because Pegfilgrastim or even Ranibizumab, if you consider both are kind of a partner product, and the prices for this product, for biosimilar prices has already corrected to the tune of 85% to 90%. So, considering that, how sizable this could be? And secondly, given the sharp price erosion that has happened already in the U.S. market, how is the European product prices there in biosimilars compared to that of the U.S.?

So even with Pegfilgrastim, as I mentioned earlier also the last couple of quarters, we've been pleasantly surprised with the opportunity that we see right now. And of course, we'll want to deliver that in this fiscal year to be able to gain that confidenc e operationally. But as we look at our partner's

forecast and what we can do in the current fiscal year, it's a really good size opportunity for Lupin. As I mentioned, I will not size up each and every product, but if I look at the next three years between U.S. and Europe with these three products or so, we have a couple of hundred million dollars worth of opportunity on the biosimilars front.

And price difference in U.S. and Europe?

In Europe, the pricing on our products is fairly stable . And like I mentioned, we're also starting to see new developments, like in Germany, these products are not part of tenders, so more of a branded opportunity on the ophthalmology front. In France, new measures that will likely enhance biosimilar adoption and ease market access for us, all of which gives us this optimism on the biosimilars front.

The next question is from Bino Pathiparampil.

Just a follow-up question on couple of products, which you mentioned. You mentioned the first-to-file exclusivity in FY27. I didn't get the name, but is that a sole exclusivity?

On Raltegravir, yes, I mentioned that.

Second one in FY28, which is the one you mentioned as sole exclusivity?

I mentioned Diazepam, Epinephrine that is two nasal sprays, Ivacaftor is another. And yes, those would be the main ones. Suflave® is another exclusive first-to-file next year.

Last question on Spiriva Respimat®. How is the market compared to the DPI?

It's moved more towards the Respimat.

If you could give some rough size idea?

We'll get back to you with that. I don't have the exact numbers.

The next question is from Kunal Dhamesha.

The first question is on the India business that you shared, that we are planning to derive one-third of the revenue from innovative products. So, can you elaborate more on this strategy, what would be the kind of required investment here, both from balanc e sheet and P&L perspective? And the usual impression is such in -licensing deals are not very accretive to profitability, right? So, what are we going to do differently? And from therapy perspective, do we stick to our key therapies of cardiac, anti -diabetic, or we look at a more high-growth therapies like oncology?

So, I think there's three avenues of proprietary products. One is our internal pipeline. So, we're building those internally. Another is in-licensing deals, as you talked. And the other most important and what will be the biggest will be pure innovative NCEs that we would bring to market, products like Bofanglutide that we announced a little while ago, which is now in the clinical development path, and in the next couple of years, we should be able to bring to market.

So, we've allocated the capital for this. It's purely India. It's not that expensive from overall licensing or a development perspective. Obviously, you need to have the entire suite of capabilities. So, you do need to have the ability to assess a new chem ical entity at an early stage, do the clinical development and bring it to market. And in a market like India, how do you build ability to do, over a period of time, 30, 40, 50 assets at a time. The goal of USD 1 billion or one-third of our business to come from innovative products is an aspiration for the next 10 years. But I think if you break it down, it basically means to be able to do 10 to 15 products every year. I think it's coming together quite well. So , in the next three years, we should start bringing those products to market and really build that pipeline. Obviously, key interest would be in our key therapy area, so which are products in respiratory , cardiology and diabetes. From an innovation perspective, obviously, 50% of what you would see as assets would be in areas like oncology, where we're not strong. Then we would cherry pick and we would pick assets that we feel can be really first -in-class, so that it can make a real difference in the market. We've started the journey. I think we've started it with putting strong capability together as well. And we'd love to keep updating you as the pipeline develops.

You are suggesting like 80 launches in India in the next three years, right? So how many of that you think would be from this market?

So, over a period of the next 10 years, we're looking at 60 to 70 launches of the innovative products. In the next three years, a very small fraction, I would say not even three, four of these would be truly innovative products.

In terms of profitability, would it be similar to our India business whenever it scales up, or how should we think in the longer run?

Certainly similar if not better. So , we would expect that. I think you already pointed to how much is the actual burn on the clinical trial s , but I think the entire model looks really good. And in the next few years, you'll start seeing positive returns coming from it.

Given that we have now established track record of selling both DPI & MDI products in U.S., how is it helping us in terms of clearing or like developing the next phase of respiratory products in terms of development cycles in your view? How the development cycles are shrinking and what are some of the learnings, which would help you bring this nex t wave of products to the market efficiently?

I'd say that in the different platforms, the complexities are different. On the MDI front, it's going to be a significant year of filings on the respiratory MDI products. I'd say on the Ellipta® platform, that was likely our most challenging platform. We've been working on it for multiple years and I'm very pleased to finally be able to get a positive PK on the first product. Now, the next major is getting Trelegy® right which our team is working upon and they're going to apply the learnings they have from B reo® onto that product.

And then on the Spiriva front, on the Respimat Spiriva, there was more of a device challenge that we faced & that now that we have cleared it and we'll file the product this year. The follow-on products become easier for us. So, I'd say different level of complexity across the different platforms, but a lot of learnings over the last couple of years that the team will leverage to be able to expedite the filings as well as potential approvals . Given that these products are either CGT or have no competition in the marketplace, the FDA is also looking to expedite these approvals. So, I'm going to look forward to leveraging that. In addition to that, a number of these products are out of India, some out of our facility in Coral Springs. We'll also want to leverage the Coral Springs domestic manufacturing in the U.S. for expedited review of these products that the administration is focused on to get more onshoring of products in the U.S.

Just one aspect of this, let's say, if you have an MDI line for one product, can the capacity become fungible for another MDI, or it does not?

It does.

On the Apixaban 505(b)(2). From here, what are the key monitorable s for you? And what's the duration advantage that we will have vis -a-vis the generics, which has slated to enter the early part of FY29, I believe?

As I mentioned, we are sizing it up, but like material brands, so one first monitorable thing that one can track is the approval. We have a goal date of September. We are hoping that we get approval in September, and then simultaneously we're building up l aunch quantities. And we expect to start having material commercial quantities start in January '27 calendar year, and we would expect somewhere in the summer that we should launch and hopefully get 10 to 12 months before others enter.

Can you share, which plant is it filed from?

It's Somerset, that's been cleared recently.

The next question is from Tushar Manudhane.

In the opening remarks, you alluded to Fluticasone nasal spray. What dosages have you filed? And like where are we in terms of the approval process?

We filed both the Rx as well as OTC. We would expect the Rx approval to come in this year and OTC in FY28.

All the formulation as well as API being manufactured in-house, or how is it?

The formulation is all in-house. The API is not.

Device is also in-house?

You referred to Apixaban 505(b) (2) right? If you could just qualitatively help understand what's the differentiation this product is going to bring compared to what the innovator's product?

We'll maybe share that closer to the launch date. We're sizing up the opportunity, and we'll be in a better position to share that over the next couple of quarters.

Just trying to understand the value addition compared to the innovator product, not so much like in terms of pricing. It was more in terms of the value addition compared to an innovator product?

It definitely would be an unmet need for patients that we've targeted. But let us come back to you with thoughts around it over the next couple of quarters.

We can take the next question from Vivek Agarwal.

Couple of questions on the cost base. If you look your staff cost and other expenses have gone up meaningfully. So, just if you can help us understand, how to look at these lines going forward, and what is driving these cost lines significantly?

The cost lines are essentially because of increments, then based on the needs of business, including India region, we have also been recruiting people. And there's also an Fx impact, at least, vis-à-vis the previous year.

Is it fair to understand right, before you launch a major product that is Apixaban and in between a couple of major products, you are seeing incremental competition, there may be a few quarters where your EBITDA margin can fall even below 20%?

There will be volatility between quarters, for sure. The magnitude is something that we can't actually speak about at this stage. But we would also do well to understand that our R&D expenditure is at least a head above the competition, firstly. And secondly, we also have the impact of adjacencies and so on, which have been captured. They're still evolving. Some of them are still making losses, though, of course, I think it will come down over time. Next year, for example, we believe the Diagnostics business will do very well. It will be break -even, for sure. And I would say the same thing for other businesses. Our Digital business is evolving extremely well. You could say that for the OTC business and CDMO as well. But I think you would do well to remember that all of these are at this stage loss making and therefore is impacting EBITDA margins and of course, our overall EPS at this stage. But clearly, that would be a thing of the past in quarters to come.

Is it possible for you to quantify what kind of the losses in terms of percentage hit on EBITDA margin these adjacencies are contributing at this point of time?

Overall about 1% - 1.5%.

It's a FY33 product for us.

We can take the next question from Saurabh Kapadia.

Just one question on the Other Developed market and EMEA. What could be the sustainable growth in this market over the next couple of years? And secondly, with the kind of growth we have seen, how the profitability or the margins in the key market have moved over the last three - four quarters?

We are looking at potentially double-digit growth, in some years., higher than others, but anywhere between 10% to 20% over the next couple of years. And the margins just given the scale of the business is growing. We've been subscale so far. And with the additional portfolio, as well as the expansion with the pipeline, we expect margins to continue to expand as well.

Do we need incremental investment to be made in any of the geography or any potential inorganic opportunity, which we could seek in any of these specific countries?

We expect to really maximize the biosimilars business. We are going to make a small, but commercial investment, in particular in the U.S., even for the 505(b) (2) of Apixaban. And our strategy on the 505(b)(2) front, because we have other products that we have targeted as well, we'll likely make a small commercial investment.

We can take the next question from Chintan Sheth.

I have a question on the U.S. side of the business where we have put out the numbers in terms of upcoming pipeline of 50 FTFs, 21 exclusive one s. If you can cumulatively provide some indication on the market size of those, and how should one look at monetizing those over the course of next three to five years? You've explained a few of the products already, but if you can cumulatively help us understand how would those numbers can contribute to our incremental revenue in the U.S. markets.

Perhaps what we can do is get back to you offline to go through the overall brand revenues and the relative products where we have limited competition. Overall, we are looking at our portfolio from the complex generics doubling over the next three to five years. That along with the fact that we believe with the pipeline we have, we should be able to grow our business in the next three to five years. With the inherent growth out of this pipeline, plus the fact that we are increasing from a complexity standpoint. We are looking at a potential expansion in margins. Of course, we'll make investments as well, as I mentioned, in maximizing these opportunities. But maybe our team can get back to you offline on looking at the overall market size and the like.

On the EMEA side, and I believe the growth is coming because of the VISUfarma acquisition for last four quarters. Base of Q2 kind of bakes in the VISUfarma. How should one look at the growth in that piece, EMEA business going forward?

We're looking at anywhere from 10% to 20% level in Europe. So, splitting out South Africa separately is a little bit lower. Just given the scale we are at. With the pipeline portfolio that we have and the opportunities, Europe should grow at that 10%-20% to level.

Any colour on the ROW market growth.

Also, double-digit growth.

To continue?

Yes.

Thank you very much. I now hand the conference over to the management for their closing comments.

Thank you, friends, for all your questions, and hopefully, we've been able to answer majority of them, but if not, the team will connect and clarify any open questions you have. As I mentioned, we are optimistic about a near -term opportunity as well as long-term opportunity. In the near-term, to be able to navigate our near -term challenges with the opportunities we have from a portfolio perspective, evolving in areas that we've invested for the last many years. In the longer -term, as Nilesh mentioned also, as we evolve innovation, innovation in India, innovation in our specialty business in Europe as well as the U.S., we look forward to delivering long-term growth as well as return for all our stakeholders. Thank you again, and we look forward to connecting with you in the future.

Thank you, ma' am. On behalf of Lupin Limited, that concludes this conference. Thank you for joining us and you may now exit the webinar.