Good evening, everyone, and thank you for joining us. I'm pleased to welcome you to our Q3 fiscal year '26 earnings call.

Joining me today are our Managing Director Nilesh, our CFO Ramesh, and our Head of Investor Relations Ravi. We look forward to sharing our Q3 performance and our outlook for the year ahead.

We are pleased to report another quarter of strong execution, with revenues surpassing last quarter's record performance. This marks our 14th consecutive quarter of year-on-year growth.

While the US continued to perform well, I would like to highlight that growth this quarter was broad-based. Most of our regions, including India prescription business, Europe, LATAM, and other emerging markets, delivered double-digit year-on-year growth.

Turning to individual businesses, this quarter was particularly strong for us in the US, where we recorded the highest sales in the region so far. [silence] exclusivity, our first product from the proprietary Nanomi long-acting inject- [silence] -table pla- An important milestone this quarter was the successful US FDA inspection of our biologics facility in Pune, followed by the approval of pegfilgrastim.

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Okay. An important milestone was the successful US FDA inspection of our biologics facility in Pune, followed by pegfilgrastim, our first biosimilar for the US market.

We have entered into an exclusive licensing agreement [audio glitch] commercialize the product with an expected launch before the end of this quarter. We see meaningful [audio glitch] commercial developments.

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Yeah.

Welcome, everyone. We are pleased to report another quarter of strong execution, with revenues surpassing last quarter's record performance.

This marks our 14th consecutive quarter of year-on-year growth. While the US continued to perform well, I would like to highlight that growth this quarter was broad-based.

Most of our regions, including India prescription business, Europe, LATAM, and other emerging markets, delivered double-digit year-on-year growth. Turning to individual business segments, this quarter was a particularly strong one for us in the US, where we recorded the highest sales in the region so far.

Growth was driven by new products such as tolvaptan, where we benefited from being the only generic on the market. We also launched generic risperidone consta with CGT exclusivity, first product from our proprietary Nanomi long-acting injectable platform.

Our base business also grew, supported by higher volumes and seasonal tailwinds, more than offsetting low single-digit price erosion. An important milestone this quarter was the successful US FDA inspection of our biologics facility in Pune, followed by the approval of pegfilgrastim, our first biosimilar for the US market.

We have entered into an exclusive licensing agreement with Valorum to commercialize the product, with an expected launch before the end of this quarter. We see meaningful tailwinds in this segment, driven by favorable regulatory and commercial developments.

As mentioned earlier, we remain focused on doubling the share of complex products in our US business over the next few years, while continuing to expand our specialty portfolio through a mix of organic initiatives and targeted acquisitions. Moving to India, revenues grew 5.6% year-on-year, with the core prescription business growing 10.9%, partially offset by lower local tender sales in our global institutional business.

On a nine-month basis, prescription growth stood at 9.4%, broadly in line with IPM growth of 9.3%. Excluding the impact of loss of exclusivity on products such as Gitolio and Ajaduo, domestic growth was 11.2% year-on-year for the nine months.

Volume growth remained strong at 5.6%, and the chronic segment now accounts for 67% of our portfolio, up from 65% last quarter. Both cardiac and respiratory therapies continued their strong momentum, growing at 1.4 times and 1.6 times their respective market growth.

During the quarter, we also launched two new divisions, including one focused on obesity. This division will engage diabetologists, cardiologists, and gastroenterologists ahead of the planned day one launch of injectable semaglutide, while we continue parallel development of the oral formulation.

In addition, we entered into a strategic partnership with Gan & Lee of China for bofanglutide, a novel fortnightly GLP-1 agonist, further strengthening our diabetes and obesity portfolio in India. We remain confident that our India formulations business will continue to outperform IPM by 1.2 to 1.3 times, supported by our strong sales force of over 11,000 people and pipeline of more than 80 new product launches over the coming years, including innovative in-house and in-licensed products.

Our other developed markets, Europe, Canada, and Australia, accounted for 11% of our total sales and delivered 11% year-on-year growth this quarter. We expect this contribution to increase as we roll out our pipeline of complex products and complete the acquisition of Visufarma, which we expect to close this quarter.

Emerging markets delivered an impressive 42% year-on-year growth, led by Brazil, Mexico, and Philippines. Brazil in particular maintained strong momentum post the turnaround last quarter, growing 99% year-on-year in local currency, driven by successful commercialization of dapagliflozin.

On R&D, spend was 7.5% of sales this quarter, among the highest in the Indian pharma sector, reflecting our continued focus on complex and specialty platforms. We have over 50 active products in the pipeline, with near-term emphasis on respiratory, complex injectables, and biosimilars.

Over time, we expect a growing share of R&D investment to flow into specialty programs and value-added medicines, including long-acting injectables, green propellant products, and 505(b)(2) assets. We are also strengthening our India innovation portfolio through both in-house development and in-licensing of late-stage assets.

On the compliance front, we received NAI status with zero observations for our Nagpur Unit 1 facility, along with EIRs for Nagpur Unit 2 injectables and the Aurangabad facility. We remain fully committed to maintaining the highest global quality and regulatory standards across all our sites.

Before I hand it over to Ramesh, I would like to reiterate that we remain optimistic about our growth prospects. We have clear strategic drivers in place to deliver sustainable long-term growth across our businesses.

Innovation will be a key differentiator, supported by continued investments in technology, including AI, to make the company future-ready and resilient as we navigate opportunities and challenges ahead. With that, I'll now hand it over to Ramesh to walk you through a detailed review of our financial performance.

Thank you, Vinita. Friends, I welcome you all to our Q3 FY2026 earnings call.

As you may have seen from the results, we have again delivered a very strong quarter, continuing the momentum of the last few quarters. Revenue from operations and EBITDA scaled a new high, exceeding the record performance we had delivered last quarter.

EBITDA margins reached 31.1%, 681 basis points higher than the similar period last year. Sales: Diving into the numbers, total revenues from operations the quarter came in at ₹7,168 crores as compared to ₹5,768 crores in Q3 FY2025 last year, a growth of 24% year-on-year.

Amongst the key markets, the US grew by 46% year-on-year. India grew 5.6% year-on-year.

Other developed markets have grown 11% year-on-year, and emerging markets have grown 42% year-on-year during this quarter. Our GIB business grew by 7% year-on-year.

The US business: Coming to the US business, this quarter, the US business recorded sales of USD 350 million, a growth of 46% year-on-year and 11% quarter-on-quarter on constant currency basis, the highest sales ever recorded for this business. This growth has been due to new product launches, including tolvaptan, and growth in base business led by higher volumes and seasonality offset by low single-digit price declines.

We're pleased with the recent approval of pegfilgrastim, our first biosimilar approval for the US, which we expect to launch shortly. We have a very exciting pipeline of products in this segment, which reinforces our growth prospects in the US going forward.

Turning to India, the India region business grew by 5.6% year-on-year during the year. I'd like to highlight that the core prescription business grew by 10.9% year-on-year during Q3 FY2026.

For nine-month period, our prescription business has grown 9.4% against IPM growth of 9.3%. In fact, if we normalize for the loss of exclusivity on some of our diabetes products, the growth would have been 11.2% in the nine months period.

Key segments like respiratory and cardiovascular grew 1.6 and 1.3 times IPM, respectively, during the nine-month period. Chronic share has increased to 67% from the 65% levels in Q2, and share of in-licensed products is only 6% as compared to around 12% in FY2025, which also has a positive impact on our profitability going ahead.

Other developed markets: As far as other developed markets are concerned, which includes markets in Europe, Canada, and Australia, revenues in these geographies was ₹812 crores, representing a growth of 11% year-on-year. Other developed markets constitute around 11% of our total sales, and their share is expected to increase going ahead with the anticipated closure of the acquisition of Visufarma during this quarter.

Emerging markets grew 42% year-on-year, with strong growth in Brazil, Mexico, and Philippines, offsetting tempered performance in South Africa. Brazil had another strong quarter, growing at 99% year-on-year in local currency terms.

Getting on to the P&L, other operating income: Other operating income for the quarter was at ₹67 crores as against ₹149 crores in Q3 FY2025 and ₹216 crores in Q2 FY2026, largely impacted by lower export benefits from the PLI scheme during the quarter. Gross margins: Gross margins continued upward trajectory during the quarter at 73.5%, up from 69.4% in Q3 last year and up from 73.3% in Q2 FY2026.

This 420 basis points year-on-year improvement is driven by multiple factors, which includes better product mix, lower share of in-licensed products, including higher profitability on loss of exclusivity products in India, increased volumes, and other cost improvements and efficiencies which we have undertaken over the last several quarters. Employee benefit expenses: This stood at ₹1,143 crores, an increase of 16.1% year-on-year from ₹984 crores in Q3 FY2025, translating to 16.1% of sales as compared to 17.5% in Q3 last year.

This change is largely attributable to higher cost due to regular annual increments and business growth during the period. Manufacturing and other expenses: Q3 FY2026 manufacturing and other expenses came in at ₹1,937 crores, increasing 14.2% year-on-year from ₹1,696 crores in Q3 FY2025, translating to 27.3% of sales vis-a-vis 30.2% last year.

The expenses were higher mainly due to higher volumes in the normal course of business. R&D at ₹535 crores is 7.5% of sales as compared to ₹441 crores in Q3 last year, with almost 70% of our R&D directed towards complex portfolio.

For the nine months ended FY20- nine months FY2026, R&D spend at ₹1,555 crores is 7.7% of sales. For the full year, as indicated, we expect R&D to be around 7.5% to 8.5%.

EBITDA: EBITDA excluding forex and other income during the quarter was ₹2,210 crores vis-a-vis ₹1,366 crores for the same period last year, an increase of 62% year-on-year, with a margin of 31.1% vis-a-vis 24.3% last year for the same period, an increase of 681 basis points over the last year. On a nine-month basis, EBITDA was ₹5,988 crores, an increase of 50% year-on-year, with margins of 29.8% vis-a-vis 24% over the same period last year.

We expect full year EBITDA margins to be in the range of 27% to 28%, higher than our earlier guidance of 25% to 26%. Whilst we expect business to continue to exhibit robust performance, overall margins in Q4 will be tempered by higher R&D expenditure and a lower PLI income.

ETR: Turning to the tax rate, ETR is expected to be about 21.4% for the nine months FY- nine months FY2026. For the full year, we expect ETR to be about 21% to 22%.

Operating working capital: This stands at ₹7,948 crores as of 31st December against ₹6,821 crores as of 31st December '25, which translates to 101 days of working capital against 103 days in the previous quarter. Net cash: Net cash stood at ₹2,879 crores as against ₹310 crores as of 31st March '25.

Whilst we focus on increased cash generation for our business, we would like to highlight that we continue to explore strategic allocation of our capital to ensure the long-term mission of the company, including on the specialty front. ESG: On the sustainability front, Lupin has achieved the highest A leadership rating from CDP for both climate change and water security, placing us amongst the select group of global companies recognized for excellence in sustainability performance and transparency of disclosures.

In addition, Lupin's greenhouse gases emissions reduction targets have been formally approved by the SBTi, reinforcing the scientific rigor and credibility of our climate ambitions. Together, these recognitions reflect the strength of our climate strategy, disciplined execution, and our unwavering commitment to creating long-term sustainable value for all our stakeholders.

With this, we open the floor for discussions.

Yeah. Hi, good evening.

This is Nikhil from HDFC Mutual Fund. I have two questions.

First and foremost, congrats on the continued great performance. Now, my first question is on the US outlook, let's say, in going into FY2029 as well.

Now obviously with the mirabegron settlement, it seems that mirabegron should continue into FY2027 and certain part of FY2028 as well. Ma'am, can you highlight what will be the drivers of the US business once tolvaptan and mirabegron start tapering off?

You have pegfilgrastim approval. We have talked about other respiratory assets.

Any help on how should we look at launches, meaningful launches over next 2 years so that once mirabegron and tolvaptan come off and you go back to a growth path in the US, that would be helpful, any color on this?

Sure. We're very pleased that we have mirabegron as a material contributor in the next two years, as well as hopefully tolvaptan also continues, just given the size of the product and the share we have so far.

We have 35% share of that market, given that it's a specialty product. We continue to build share on tolvaptan.

Having said that, we have multiple new product launches planned over the next couple of years, in particular on the injectables front, some on the respiratory front, as well as the biosimilars front. As I look at the last couple of quarters, we've got approvals for injectable products like glucagon, liraglutide, risperidone consta, and with the pegfilgrastim approval, getting into the biosimilars market as well to build the institutional business.

The institutional business will be a material build over the next 3 years, and we see it really ramping up very nicely over the next 3 to 5 years to be a material contributor to the US business. Likewise, the biosimilar business in particular will also be a material contributor to the US with pegfilgrastim, then ranibizumab that we hopefully will be able to launch in fiscal year '27, and then the on-body pegfilgrastim, which is making good progress, and then aflibercept and etanercept in '29, calendar '29, that'll be actually fiscal year '30.

Then we have other products that we have planned as well, like mepolizumab, that are in the pipeline. Pretty rich pipeline of biosimilars that we believe, given the current momentum in the marketplace, access into the market will be a material growth driver for the organization.

The additional, I'd say, growth driver which so far has not featured into our business is 505(b)(2)s. The company has been working on 505(b)(2)s for the past couple of years, especially on the injectable front.

In fiscal year '27, we will start our first 505(b)(2), and that's going to ramp up in the next couple of years as a material contributor as well. We have multiple growth drivers at this point for the organization and feel fairly confident that we can, one, sustain this billion-plus revenue level over the next couple of years and build from there as we bring material biosimilars, respiratory products, as well as injectables, including the other first-to-files that we have in our portfolio, to market.

Yep. If I look at the three biosimilars that you talked about in the more near term, which are pegfilgrastim plus ranibizumab plus aflibercept, now assuming that approvals come through in FY2027, in FY2028 and '29, these three products, can they contribute, let's say, a $100 million or round about that kind of a number in next 2, 3 years, the combined basket of these three products?

The potential is there.

Understood. Also, you have tentative approval for this product, Xywav.

I guess the litigation is ongoing. Any probabilistic launch timing of this product?

I suspect Lupin could be sole FTF in this product?

We are exclusive first-to-file on that product. The launch date, I believe, is fiscal year '29, if I'm not mistaken.

Got it. Understood.

One final question I have on the India business. I think the Jan IQVIA data is showing good growth.

Also last quarter, ex of the tender business, I think the growth has come in good. Are we in a good, let's say, 12%, 13% growth environment for the company?

With all the IL issues in the base now and insulin tailwinds?

Yeah. I think 20% to 30% ahead of the market is what we would see ourselves at.

The market is growing strong, double-digit growth is assured, and I think not just for the next couple of quarters, but I think for the next couple of years, we would expect to continue growth. I think a lot of the exclusivities are behind us, the insulin opportunity is there, semaglutide will come in as well.

Lots of positive growth drivers for India.

Got it. This is helpful.

Thank you so much.

Thanks for the opportunity and congrats on the good set of numbers. Just on your comments on use of AI, if you could elaborate which geography or which divisions have we sort of started implementing use of AI and how faster or difficult, whichever way, the use of AI has been on the development side, on the manufacturing side?

We have made some good progress on AI, and this is across the entire company. We started off with sales and marketing, but clearly we are looking at other divisions also.

Manufacturing and maintenance is one other part. The other is, of course, quality and the like.

We're working with multiple consultants. The first, most important thing is the fact that we need to bring all of this data together.

Over time, we've actually created several repositories, and it's important to actually bring everything together under one architectural roof. That's exactly what we're trying to do at this stage.

Clearly, we have set our eyes on AI for all our functions, including finance, HR, legal, and procurement and the like. We expect a lot of these pilot projects that we've been working on to be kind of implemented over the next 9 to 12 months.

Got it, sir. Secondly, the opening remarks also alluded to forming a new division for semaglutide with respect to catering to diabetologists, cardiologists, gastroenterologists.

How many MRs is sort of getting focused for this particular product?

It's about 200 people, but I think we'll scale it up as needed.

How do you see this, because given that there are going to be multiple players, of course, there will be a pricing impact, but volumes scaling up. Again, how the demand is expected to shape up, that is something really interesting to watch out.

If you could throw your insights on this opportunity for India market?

I think many companies are going to launch it. The fact that we're a large cardiometabolic player will make sure that we are able to get the right kind of prescription share in this product.

There's a lot planned. Again, what we're saying is not unique.

Everybody else is planning extra bells and whistles from that perspective, but I think we have a very deep patient support program that we intend to engage into this as well. We believe that we'll be there on day one.

Again, as a large cardiometabolic player, it should be a nice opportunity. While we've created this division, we have the ability to scale up, we have the ability to add it into other divisions as well.

I think it would be interesting. Let's see.

I think it's just a month away.

Great. All the best.

Thank you.

Hi. Good morning and good afternoon.

Just a follow-up on mirabegron settlement. From your notes, I see that you have taken a provision of $15 million, whereas the total payout $90 million.

Why only $15 million provision?

Yeah, 15 is essentially what relates to, as they say, the past, whilst 75 is linked, in fact, future being in the market. Clearly, it relates to the future, and that's the reason why finally 15 at this stage.

The balance 75 will be spread over the next up to September '27.

Okay. That will come in other expenses later on in quarters.

It's actually would not impact the EBITDA because it's actually a license that we need to kind of amortize over a period of time.

Got it. Second, now that we have a license in place, is there room to improve our mirabegron market share?

Because I believe we were selling much lower quantity than the other generic competitor. Is there a chance to equalize this?

Also, we have 40% generic share, and generics, between us and Zydus, we also have 40% of the overall molecule. We'll see what makes sense.

It's a really good contributor to our P&L, and we'll determine if it makes sense to take on additional share.

Got it. Why this end date of September '27?

Because the next Orange Book patent of mirabegron expires only in 2030. What prevents you from being exclusive in the market till then?

Till 2030, you mean?

Yeah. Till the next patent expires.

We believe majority of the settlements that the brand has entered with other companies are to that date in '27, September '27.

Okay. One last question on tolvaptan.

How do you see the competitive scenario panning out? Why hasn't Apotex launched till now?

Do you expect more approvals?

Not certain why they haven't launched. We know that IP is certainly a hurdle that we have crossed, and the others haven't, so that could be a consideration.

It's not the easiest product to manufacture. That could be another consideration.

We don't have any intelligence on Teva's approval. Then we know that other competitors have November '26, 30-month stay date and into '27.

We think that if competition comes in, it's likely going to be staggered.

Got it. One last, if I may add in, any update on Breo Ellipta in your pipeline?

We're still making progress with the development. We were hoping to have it filed by now, but I'd say that is still actively in our respiratory pipeline.

We hope to really make material progress this calendar year.

Thank you. I'll jump back.

Thank you.

Hey. Hi.

Can you hear me?

Yes.

Yes.

Yeah. Thank you for the opportunity.

First one, just trying to understand the mirabegron settlement a little more. We have this licensing outgo $75 million plus we have a per unit licensing fee that we'll pay, right?

Are those separate? Are those same thing?

How to think about that?

They're separate. Can you still hear us?

taken off from the revenue or

Kunal, can you repeat your question, please?

We can't hear you.

Can you hear me now?

Yes.

Yes.

Yeah. Basically, the prepaid per unit licensing fee, how will we account for that?

Will it be offset from the revenue, or will it be recognized in COGS or how to think about that?

There are two portions, as we were just mentioning. There is a smaller portion which actually has to be knocked off from the overall operating profit, and there's an element which will actually get amortized over a period of time.

Both will actually hit the P&L.

Okay. One above EBITDA, one below EBITDA.

Yeah.

Would you say that with this settlement, the profitability of this product changes materially if we just look at from an above EBITDA perspective?

The fact of the matter is it will impact profits, but we still think it's still going to be attractive enough.

Sure. Sure.

Second question on the overall profitability outlook, let's say, beyond FY2026. I think earlier we had suggested for FY2027 EBITDA margin range of around 24% to 25%.

How do we think that is going to play out now with the kind of products that we have in US and India, etc.?

Clearly, the top-line buoyancy would continue, and we just mentioned about the fact that mirabegron will have a fresh lease of life, to speak. Tolvaptan, we are not seeing competition, though, of course, we do expect that to enter at some point of time.

Vinita alluded to a number of new product launches that could potentially happen next year, and there's semaglutide opportunities and the like. Of course, there are opportunities in emerging markets.

Clearly, we are very bullish about, in fact, keeping the top-line buoyancy going. There is tremendous focus on costs as well.

There are a number of initiatives that we've taken up in recent times. All of this would also kind of help us to kind of maintain the gross margins and thereafter the EBITDA margins also.

Whilst there would be a dip in terms of margins vis-a-vis the current year because of sheer competition for some of the products, we still believe that we'd be good for actually looking at 24% to 25% next year.

Sure. Last one for Nilesh sir on the semaglutide generic launch.

What is your expectation, let's say, from a year one market perspective? How much it can grow?

Did we allude to potential revenue size in year one in one of the media interviews, if I heard it correctly?

Yes, we did. I think the internal modeling that we have at this point of time seems to suggest that this will be a 15-odd ₹1,500 crore odd opportunity in the first year.

We talked about maybe doing ₹50, ₹60 crores, something like that in the first year. We'll see.

I think there's just too many variables right now, how much is the pricing going to go down, how much is the pent-up demand. You've seen how Mounjaro went in the first 5 months since launch, right?

When this happens, the price point, what it means, and we want to be responsible. We want to do this the right way.

We don't want to just sell this for the heck of it. I think the intent would be to do it in as responsible a manner, but I think it should be a nice opportunity.

Sir, supply wouldn't be an issue, let's say, if we think about equitable market share or whatever we are currently having in cardio-diabetic space, if we want to achieve that kind of market share? We're good enough supplies, right, for the market?

Yes, we don't see a concern at this point.

Sure, sir. Thank you, and all the best.

Thanks for taking my question. Ramesh sir, on the 25% margin that you've mentioned for fiscal '27, given that we have a fair bit of visibility on mirabegron and also tolvaptan at least for next few quarters, how should I think about the cost, other than the investment in the field force expansion that you talked about?

What should be the R&D increase or investments in other areas that you're looking at?

Clearly, there is a lot of focus on costs, and whilst that'll certainly continue, there would also be spends for R&D, which may increase given the fact that we are focusing on a number of things out there. Clearly, combined with the fact that there would be some tapering off of top-line products and the fact that we might have to provide for extra expenditure on the R&D, we're just being conservative in saying about 24% to 25% would be par for the course.

The R&D next year would be in the 7.5%, 8.5% range, or would it be lower as a percentage of sales?

I think 7.5%, 8.5% is clearly a good number to look at at this stage.

Understood. Vinita, you called out seasonality as one of the factors for the strong growth that we saw in the US.

Was that a meaningful contributor to the quarter-on-quarter improvement in the US sales or was a large part of that driven by tolvaptan, mirabegron?

No, tolvaptan, mirabegron certainly were the larger contributors, but even products like albuterol, tiotropium, oseltamivir have grown quarter-on-quarter because of the seasonality.

That should normalize a little bit, right, as we go into the next few quarters?

Yes.

Okay. Got it.

Thank you so much.

Yeah. Hi.

Thanks for taking my question. Vinita, just wanted to get your thoughts around some of the recent regulations that we've seen around PBMs in the US.

Now, my understanding is a large part of the benefit will probably flow down to the end customers, the payer, and this is largely neutral from a generic manufacturer's standpoint. Now, is that how you also probably look at it, or could there be any change in terms of the industry dynamics, rebating levels, etc., which you probably foresee?

Sorry, I missed your question, the front end of your question. Can you repeat it?

Yeah. I just wanted to get your thoughts around the recent regulations around PBMs which we have seen in the US.

Regulations around what?

PBM.

PBMs in the US.

Oh, PBMs. Okay.

Yeah.

Yeah.

The understanding is a large part of the benefit will probably flow through to the end customers and payers, and this is largely neutral from a generic manufacturer's standpoint. Now, is that how you also probably look at it, and could there be some meaningful changes in terms of industry dynamics or rebating levels which you probably foresee?

Yes, the new administration has been focusing hard on the PBMs, and also the Trump Rx has gone live in the past couple of days that really nets out the pricing for a number of the brand companies as they've committed in the agreements that they have signed with the administration. For the most part, as we understand it, the companies have really given the benefit of the rebates to PBMs to the government so that that benefit can be offered to the patients and consumers.

We really don't see a material change in pricing.

Got it, Vinita. Thank you.

Just a second one. I believe you quickly called out the growth figure for Europe.

If you could just share that for this quarter?

It was 11% growth.

Yeah. Got it.

Thank you. That's it from my end.

Yeah. Thank you for the opportunity again.

I just wanted to understand the injectables strategy, let's say, from a 2, 3 year perspective. Great to have products like glucagon and risperidone consta, Victoza approvals and having been launched.

I suspect none of these products would be big enough to kind of move the needle so much as far as the overall injectable space sales is concerned. How far are we from a big material launch on the injectable side?

Can you talk about what products have been filed, what are you looking at, and which sort of products can give you, let's say, a $100, $200 million kind of a sales base on the injectables, and over what time period can you achieve that?

Apart from the products I mentioned, we also have dalbavancin that we have filed, that both the injectable, the generic version, as well as a 505(b)(2) version of the product. We have eribulin, smaller product.

Just looking through the major products iron sucrose will be a material one for us, and yeah, more 505(b)(2)s that we haven't announced. We really see the injectables portfolio ramping up in the next 3 years to 100 million-plus, with multiple tens of millions of dollars in individual products, and then biosimilars adding to it.

Understood. On pegfilgrastim, it seems like while it's great to have the approval in place, but can it be a meaningful revenue driver because there is competition there, some of the biosimilars are pretty well established for a number of years now?

What's the go-to-market strategy on pegfilgrastim now? When do we start numbers showing up for Lupin in this product?

We would launch this quarter, but you'll start seeing numbers really in the next fiscal year. We are very encouraged with what we are hearing from the marketplace.

We've tied up with this company with strong experts across the biosimilars market, from the McKesson and other AmerisourceBergen and other specialty distribution groups, and we see a real place for a new pegfilgrastim in the marketplace. I'd say a couple of years ago we were not very gung-ho on biosimilars, but today we see significant potential with pegfilgrastim to start with, but also the other biosimilars that we have in our pipeline.

Just curious. With so many biosimilars in this product being already there, why would a ABC or a McKesson tie up with Lupin?

Is the cost going to be the proposition here? If the cost comes off, would the margins be lucrative enough for you to make money on this product?

Typically a new product is attractive from a reimbursement standpoint to the payers. That itself will drive the initial uptake, and beyond that, you've seen a number of companies that have driven the price down actually get out of the market, and potentially they will relaunch with a different pricing strategy into the marketplace.

We really see the market for biosimilars and for pegfilgrastim shifting. Also, we are the only truly integrated player with the India cost advantage.

Having our own API, our own finished product, the other companies don't have the advantage that we do.

Understood. Okay.

Got it. Thank you.

Hi, good afternoon. My question is on R&D spends.

In the last couple of years, your R&D budget has gone from around ₹1,400, ₹1,500 crores to around almost ₹2,100 crores now. If you would like to share which area that you're spending in, how much of this would be on biosimilars that you have budgeted?

Because some of these spends, I think would come off also in the years ahead. Is there a chance that maybe after FY2026 or '27 your R&D starts going down also?

No, I wouldn't think so. Clearly, we are spending on the more complex stuff, which includes the injectable space, the inhalation space.

Any drug-device combination always costs a lot of money with clinical trials and the like. Of course, we have our biosimilars.

We have also always spoken about specialty ambitions and the like. Clearly, the spends would keep going up.

If our turnover keeps going up also, as a percentage of sales, it might actually languish at a particular point, but in absolute value terms, it would certainly keep going up.

Sure. If I understand correctly, you're not adding more projects, it's just that you're expanding into a bit more high value, high cost projects?

It is adding more projects overall.

You're pivoting to more complex stuff, right?

Right. Then Okay, let me put this way.

Is your budget on generics, the usual Para III and the Para IVs, oral solids and all, is that same, or that is going up?

Actually, in absolute terms and percentage terms, it would be going down.

Mhm.

Okay. Okay.

That's good to know. Second question, again, you have now a healthy cash balance.

You are generating cash. Is specialty on your radar?

Exactly which therapies, in which markets would you be targeting?

Yes, it has been on our radar, as we have shared in the past, and the therapy areas also we've been pretty vocal with respiratory being an area that we would like to build given our current position, as well as neurology, where we have Namuscla to start with. We are planning to bring Namuscla into the US and would like to get other products in the therapy area.

Third now is ophthalmology. Maybe have a start in Europe with Visufarma, but we'd like to get additional assets both in Europe as well as ideally US, Europe, and other developed markets.

Would you be more comfortable buying assets which have been approved or ones where you perhaps have to do a Phase III trial, file it, and then commercialize it?

Yes, we've been looking across the board. Of course, commercialized assets would be very lucrative, but they are far and few because companies don't part with them easily.

We're also looking at assets that are in Phase III or have completed Phase II successfully and are ready to go into Phase III.

Sure. Just one more if I can, please.

At last year, you had announced that for tiotropium, you had tied up with someone, a company in China. Do you think that's a meaningful opportunity for you?

Oh, you mean for the Chinese market?

Tiotropium in China.

Yes.

Yes, I think it continues, not very meaningful.

It's not meaningful now, or you don't expect it to be meaningful in future, too?

It's not in the market, right?

It's not approved.

Okay. Got it.

Thank you.

Yeah.

Hi. Thanks for taking my question.

The first question is on the overall biosimilar landscape in the US. We see recent developments which are all aimed at improving affordability and accessibility, which is good, structurally positive for us as well.

At the same time, it is also going to make market more competitive. How should we think about what will be those key factors which will determine our success?

You mentioned about having that cost advantage, but I'm assuming a lot of Indian companies would have that. That's number one.

The second is we also see PBMs having their own brands or bringing their own labels in this space. That adds to the competition, right?

How do you think about that relationship?

I'll maybe take the second question first. When it comes to the private labels, that's actually avenue for us as well to gain share.

When we see the Cordavis label, for example, that really drove significant share for Sandoz. We certainly see that as a positive for a biosimilar.

What we are starting to see is the block of the PBMs is actually going down. PBMs are partnering now with biosimilars to really bring access to biosimilars in the marketplace.

That is one. Second, we're very mindful of the fact that with the market opening up, the regulatory requirements are becoming less burdensome, competition can increase.

We are very selective in our selection process of our pipeline. We are selectively going after programs that we believe we can be in the first wave, we believe we can be one of few based on technology advantage or otherwise.

Third, we also have our lens of the three therapy areas that we want to build in the specialty front, because we also are building commercial front end for the three areas that we can leverage across biosimilars as well as branded specialty products. We're kind of carving our own therapeutic area strategy as well on the biosimilar front.

All of those give us a confidence that we're not going after everything under the sun from a portfolio standpoint. We're being very selective around areas where we can truly make a difference.

The other thing I will say is, while you hear about the cost advantage of India across the generic drug companies, just look at how many biosimilar companies are out there. There are a handful of biosimilar companies at scale across the world, between India, Europe, as well as Korea.

It's not the same level of competition as you see in the small molecule generic industry, which also makes biosimilars a more attractive area overall.

That's very helpful, ma'am. Also just a second question, which is a clarification on mirabegron.

If I think about $90 million of payment, is it more or less what we have earned so far on this product or much lower than what we would have made? That's number one.

Second, with the settlement until September '27, does it mean that we should not anticipate any generic players to come in this period, or they could come and settle with similar terms, that is, paying royalty, etc., on the sales that accrue to?

It's hard to predict what other generics will do. For us, it's given us certainty, right?

We have no litigation burden anymore, no risk, and no impediment to sell the product in the marketplace. We still look at it as a very attractive contributor to our P&L.

All right.

Hello.

We can hear you.

Thanks. A couple of years back, you have highlighted that you are developing a product, it's a drug-device combination called Nexplanon.

Just want to understand where the product is. Is it still in the development, or have you filed this product, any status regarding this product?

Thank you.

It is in clinical development right now.

Don't you think that's quite long, that is still in the clinical development and all? When you expect to file this product?

I believe it is planned to be filed in fiscal year '28.

Fiscal year '28? Okay.

It is a long development cycle, also pretty complex development.

Understood. Second question is related to India business where I think you have turned the business quite well in the last couple of years, and Rx business is doing phenomenally well, right, and the confidence is also there.

Just to understand the next 3 to 4 years, how to look at the growth trends of India Rx business, and if you can outline, for example, the kind of initiatives that you are taking in terms of product launches, in terms of market penetration, sales force, etc., so that what gives you the confidence that you could continue to grow this business? Thank you.

Yeah. Our aspiration would be to continue to grow double digit.

We believe that the market will grow 7%, 8%, and therefore, we will grow double digit in this segment. That is linked with the fact that our focus is on chronic therapy areas.

As 65% of our revenues come from chronic side. We're doubling down.

We added 900 people to our sales force in the last 6 months. We're doubling down on the market.

We have expanded into newer divisions, into newer therapy areas as well. We haven't even done the innovation pipeline yet.

I think that's something which has just started. In the next 3, 4 years, you'll start seeing more innovative products coming from our portfolio as well.

I think a combination of the need for the market, expanding our reach, expanding the breadth of our offering as well, all of these together will drive it. We've talked about in the past about other things like patient support and the like.

I think all of these together will help deliver this growth.

Understood. Just last question if I can squeeze in in terms of capital allocation, right?

Apart from R&D investments that you are making, and you are generating significant cash. If you can prioritize, let's say, I think top three areas where you want to spend money, let's say, in the next 3 to 4 years.

Thank you.

Clearly, we have the ability to borrow about $1.5, $1.6 billion, to speak, apart from of course what we have on our balance sheet in terms of cash already. From a purchases perspective, we would be looking at, in fact, specialty assets.

Hitherto, we have been looking at, in fact, something in the range of sweet spot being about 250 to 300. We might up it a little more based, again, on the proposition on the table.

That's the most important part for us. We have also clearly defined the threshold limits when it comes to, in fact, adjacencies and so on.

We would invest only in as much as the initial estimates were. Clearly, that's, again, a threshold limit.

Of course, we'll be interested in actually looking at assets in India. The sweet spot here again being about $250 to $300 million.

Understood. When you talk about specialty assets, right, is it mainly related to US, or are you also comfortable buying some assets, for example, which might be making losses initially and can turn profitable over a period of time?

Yes, we are looking at US, Europe, developed markets, like the Visufarma was Europe, right, and US as well. As you mentioned earlier, we are looking at clinical stage assets, too, that will require investment before we bring it to market.

Understood. Thanks.

That's from my side.

Maybe last two questions?

Yeah. Thanks, Vivek.

We'll take the next question from Shyam Srinivasan.

Hi. Good evening.

Thank you for taking my question. Just a touch on Visufarma again.

I'm sorry, I missed maybe the opening remarks. Has it now closed, the transaction?

When are we starting to consolidate it? I remember 57 or 60 products, €50 million, €55 million was the annual expectation.

If you could just refresh those numbers, please. Thank you.

We expect to close it in the next few weeks of this quarter basically. We'll start consolidating next quarter onwards.

The revenue is very much stay on track. I believe 60 million-plus for

Close to that, yeah. A little more for the next fiscal.

Clearly, for the numbers that he spoke about for this year.

Yeah. Sorry Ramesh, euros or dollars?

Sorry, just

Euros. All of this is in euros.

Euros, euro million, right? Got it.

Margin, I remember, was also high, 25% or 30%, if I remember right?

That's at EBITDA. Based again on our cost synergies and all of that, it will actually get to that level.

It'll actually more.

But 25% to start.

Yeah.

Yeah.

Got it. Very helpful.

Second question on emerging markets. Is there a base effect?

Because we had 40% plus growth. Any geographies to call out?

Is it

Brazil that we called out. Brazil had almost doubled in the quarter.

Thanks to dapagliflozin that we actually introduced out there,

and

of course, a lineup that we have for the future that will kind of continue for some time.

Sorry, Ramesh, maybe constant currency growth 40% seems odd. Is it local currencies?

What are these growing at?

It's actually nearly doubled in terms of turnover given the fact that this product is a big hitter out there.

Got it. Lastly, on India growth, I know the 5.6% volume growth is nine month.

What's the 11%

No, 5.6 is actually taking into account the fact that we actually had the

No, nine-month volume growth.

Nine-month volume growth, but I'm just looking at, say, Q3 in this 11% prescription growth, what is the price volume split, and how has chronic done? I think that's my last question.

Chronic has done extremely well.

Chronic has done well. I want to say it's similar on the volume in Q3 as well.

Actually, the share of chronic has gone up to 67%.

Volume growth was 6.5%, and new products gave us 1.5%.

Mhm.

Sorry, Nilesh, your voice is cutting. Can you repeat?

Volume growth was 6.5% for Q3, and it was 5.6% for nine months.

Perfect, yeah. Thank you and all the best.

Thank you all. Sorry for the technical glitches, but hopefully we were able to respond to all your questions.

We are very optimistic at this point to close the year on a very strong note, and equally the year ahead looks pretty strong. We continue to work around our strategic growth drivers to build specialty and our complex platforms to enable us to grow sustainably over the next few years.

Thank you again for joining us, and we look forward to interacting with you in the next couple of months.