Good afternoon, friends. I'm very pleased to welcome you to our Q1 fiscal year '27 earnings call.

I have with me our MD Nilesh, and our CFO Ramesh, and our Head of Investor Relations Ravi. We look forward to sharing with you our highlights for the quarter, as well as the outlook for fiscal year '27.

We are delighted to announce a record quarter, with total revenues from operations and EBITDA exceeding ₹8,000 crores and ₹2,400 crores, respectively, for the first time in our history. This quarter also marks a record 16th consecutive quarter of year-over-year growth for the company.

While the US has obviously had an exceptional contribution to this performance, I would like to highlight that the ex-US organic revenue growth for the company has been a strong 20% plus year-over-year, and a strong double-digit growth in all our key markets including India, other developed markets, and other emerging markets. This geographically diversified business model, combined with our unwavering focus on operational excellence, creates a sustainable foundation for future growth, even as we navigate the increased competition in some of our key generic products in the US this year.

Turning to individual business segments, our US business sustained its positive momentum and delivered another quarter of robust sales performance. While we benefited from the higher volumes in base portfolio and growth in products like tolvaptan, this was offset by increased competition in products like mirabegron.

For the full year, we expect the US business to be in the $1.1 to $1.2 billion range, aided by growth in base business, our injectable launches, and contribution from pegfilgrastim, offsetting the additional competition in products like mirabegron and tolvaptan during the year. Going ahead, we remain focused on doubling the share of our complex products in our US business, led by respiratory and complex injectables, and augmented by biosimilars.

In the next 3 years, we expect to launch 50-plus products in the US, with 10 exclusive first-to-files, 5 biosimilars, as well as 2 to 3 505(b)(2)s. We're planning to file more than 15 products this year, including at least 7 in the respiratory segment.

We believe that all these initiatives should help in the US getting back to its growth trajectory from fiscal year '28 onwards. Coming to India, our India business has grown 13.9% year-over-year in the quarter, with the core prescription business growing 15.1%, representing a 1.1 times growth against IPM.

Volume growth was strong at 6.1% during the quarter. The chronic segment accounts for around 67% of our portfolio, up from around 65% in fiscal year '26, and we have set ourselves a target to increase the share to 70% in the next 5 years.

Most of our key therapy areas outperformed the respective market growth, with anti-diabetes segment and cardiac segment growing 1.8 times and 1.2 times their category growth. I would specifically like to mention our diabetes segment, which grew at 31.8% year-over-year, a second consecutive quarter of 20% plus growth, led by market leadership in human insulin and successful launch of semaglutide injection.

This segment is poised for continued healthy growth with the expected launch of vial and oral dosage forms of semaglutide in the second half of this fiscal year. We remain confident that our India formulations business will continue to outperform IPM by 1.2 to 1.3 times, supported by our strong India prescription sales force of nearly 11,300 people and pipeline of more than 80 new product launches over the coming years.

We have set ourselves a target of novel proprietary products contributing 1/3 of our India revenues in the 10-year time frame. This innovative portfolio for India will come from in-house development, as well as in-licensed products, leveraging our strong partnership track record, brand building, and development regulatory and clinical capabilities.

Our other developed markets—Europe, Canada, and Australia—accounted for 14% of our revenues in this quarter, up from 11% in fiscal year '26. Sales grew 48% year-over-year in the quarter.

Our European business continued its strong momentum with 83% growth year-over-year. We believe that we are under-indexed in Europe, and have set a clear pathway to grow this business with complex generics, biosimilars portfolio, as well as specialty acquisitions, such as Visupharma.

Emerging markets delivered an impressive 52% year-over-year growth, led by Brazil, South Africa, and Philippines. Brazil continued the strong momentum of the last 4 quarters, growing 117% year-over-year in local currency during Q1, driven by successful commercialization of dapagliflozin and launch of empagliflozin.

As mentioned earlier, we are starting to establish a presence in the diabetes metabolic space in the emerging markets, with Dapa serving as a strong start, and the launch of Empa in Brazil and South Africa, as well as semaglutide in South Africa later this year. Turning to R&D, our spend was 7.4% of sales this quarter, with 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. We've also evolved a strong 505(b)(2) pipeline in the last couple of years, and will start seeing product launches this fiscal year and ramping up in the next 2 years.

We're also strengthening our India innovation portfolio through both in-house development and in-licensing of late-stage assets, as I mentioned earlier. Switching to compliance, we received EIRs for Ankleshwar and Somerset, with VAI status from US FDA for both sites during the quarter.

With regards to Pithampur Unit 2 facility, we have submitted our responses and remain on track with our remediation efforts. We are fully committed to maintaining the highest standards of quality and compliance across all our sites globally.

In conclusion, while we have started the year on a strong note, as indicated earlier, we anticipate some moderation in performance during the remainder of the year, especially in the US from increased competitive intensity on our 2 major products. We are closely monitoring the potential headwinds from an uncertain geopolitical environment, as well.

We would like to reiterate our earlier guidance of high single-digit revenue growth for the organization, with EBITDA margins of around 25% during the year. Before I hand it over to Ramesh, I would like to say that we are optimistic on our future growth trajectory.

We are on the path to strengthen our diversified business model, while we continue to evolve our business into higher-barrier generics, branded, as well as innovative products. Ramesh, over to you.

Thank you, Vinita, and friends, I welcome you all to our Q1 FY '27 earnings call. I'm happy to report another record quarter of earnings, with total revenue from operations growing 32% year-on-year to ₹8,277 crores, and EBITDA, excluding forex and other income, growing at strong 50% year-on-year to ₹2,464 crores.

This marks the 16th consecutive quarter growth for the company. What is heartening is that the growth has been diversified and robust across our major geographies, be it the US, which grew by 43% year-on-year; India prescriptions, which grew 15.1% year-on-year; other developed markets, which grew 48%; emerging markets, which grew 52% year-on-year; and our Gx business, which grew 40% year-on-year during the quarter.

As Vinita mentioned, our organic growth ex-US was a strong 20% year-on-year during the quarter, bearing testimony to the resilience of our business model. During the quarter, the US business recorded sales of USD $366 million, 30% higher than year-on-year in constant currency terms.

This growth has been driven by higher volumes in base business, offset by additional competition in key products like mirabegron. Whilst we continue to benefit from our differentiated strategy on focusing on complex products, as indicated in our earlier interactions, the overall sales in the US will be impacted by competition in key products like mirabegron and tolvaptan this year.

However, we anticipate the business to revert to its growth trajectory from FY '28, largely led by a rich pipeline of products, including exclusive first-to-files, biosimilars, and 505(b)(2) products. In addition, we have an attractive pipeline of more than 60 products in injectables and our respiratory products currently under development, which will augment our complex portfolio going ahead.

India region: during the quarter, the India business recorded sales of ₹2,380 crores, growing 13.9% year-on-year. I would like to highlight that the core prescription business grew 15.1% year-on-year, as against IPM growth of 13.5%, translating to 1.1x times IPM growth.

This is offset by lower tender sales in our generic business in India. Key segments like diabetes and cardiology handsomely outperformed their category growth at 1.8x and 1.2x times, respectively.

This is offset by lower growth in respiratory segment, which grew 6.9% as against category growth of 11.3%. Volume growth has been a healthy 6.1% during the year, and the chronic share in the mix has increased to around 67% from around 65% in FY '26.

The share of in-licensed products in this quarter is around 6%, similar to the FY '26 levels. We have launched around 7 products in Q1 FY '27, and plan to launch about 20 products in FY '27, vis-à-vis 15 products which we had launched in FY '26.

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 more than 11,000 people and pipeline of more than 80 new product launches over the coming years, including innovation in-house and in-licensed products. Other developed markets: for the quarter, other developed markets—Europe, Canada, and Australia—recorded sales of ₹1,149 crores, growing 48% year-on-year, and accounting for 14% of our total sales, an increase from 11% in FY '26.

I would like to highlight that we have begun consolidating Visupharma in our financials from this quarter. As Vinita mentioned, we are focusing on various strategic initiatives to grow our business in this region, especially in Europe going ahead.

Emerging markets: for the quarter, emerging markets recorded sales of ₹990 crores, delivering an impressive 52% year-on-year growth, led by markets in Brazil, South Africa, and Philippines. Brazil in particular maintained strong momentum post the turnaround of the last few quarters, growing 117% year-on-year in local currency, driven by successful commercialization of dapagliflozin.

Going on to the P&L: our other operating income at ₹60 crores is as against ₹105 crores in Q1 FY '26. It has decreased 43% year-on-year.

This decrease is primarily on account of lower export benefits from the PLI schemes during the year. Gross margins: coming to the profitability of gross margins, the upward trajectory continues, this quarter was 74.6%, up from 71.3% in Q1 FY '26 last year.

This 330 basis points year-on-year improvement is driven by multiple factors, which includes better product mix, higher profitability in India, increased volumes, and cost improvements and efficiencies which we have undertaken over the last several quarters. Employee benefit expenses: for the quarter, employee benefit expenses stood at ₹1,383 crores, increasing 28% year-on-year from INR 1,083 crores in Q1 FY '26, translating to 16.8% of sales versus 17.6% 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: Q1 FY '27 manufacturing and other expenses came in at ₹2,341 crores, which translates to approximately 28.5% of sales, as compared to 28.7% of sales in Q1 last year.

The expenses were higher mainly due to higher volumes in normal course of the business, higher SG&A expenses on account of field force expansion, license fee payments, and a part of settlement agreements. R&D at ₹608 crores is 7.4% of sales in Q1 FY '27, as compared to ₹498 crores at 8.1% of sales in Q1 FY '26.

For the full year, R&D is expected to be around 8%. EBITDA: EBITDA, excluding forex and other income during the quarter, was ₹2,464 crores, vis-à-vis ₹1,641 crores in the same period last year, an increase of 50% year-on-year, with margins of 30% vis-à-vis 26.6% last year in the same period, an increase of 340 basis points over the last year.

During the full year, as indicated by Vinita, we expect EBITDA margins to be around the 25% mark. Depreciation and amortization at ₹453 crores, as compared to ₹299 crores in corresponding quarter last year.

This increase is due to higher amortization of settlement agreements. The effective tax rate stood at 29.8% for the quarter.

For the full year, however, we expect it to be in the region of 27% to 28%. In respect to balance sheet items, the operating working capital was ₹8,260 crores as at 30th June '26, as compared to ₹7,132 crores as at 31st March '26, which translates to 90 days of net working capital, as compared to 87 days recorded earlier.

The net cash stood at ₹2,831 crores as at 30th June, vis-à-vis ₹4,636 crores as at the 31st March quarter, largely due to closure of our Visupharma acquisition. Whilst we focus on increased cash generation for our business, we'd 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.

ROCE for the company translates to 29.5%, vis-à-vis 28.4% as at end FY '26. On the ESG front, Lupin continues to advance steadily towards its 2030 sustainability goals, achieving approximately 41% reduction in greenhouse gas emissions and 45% water recycling as of FY '26.

Our efforts have been recognized externally through inclusion in the TIME World's Most Sustainable Companies 2026 list for the first time. With this, we open the floor for discussions.

Thank you very much, sir. We will now begin the question-and-answer session.

Request that all the participants who wish to ask questions to raise your hands on the participant tab on the screen. We will wait for 30 seconds for the queue to assemble.

Thank you. Thank you for your patience.

We'll take the first question from Damayanti Kerai. Damayanti, are you there?

Hi. Thank you for the opportunity.

My first question is on your opening remarks where you mentioned that US sales should be back on growth trajectory starting FY '28. Just want to understand, this growth will be on the base of US $1.1 to $1.2 billion number which you mentioned for '27, or how should we understand this part?

That's right.

Over the

fiscal year '27 base.

Okay. You'll grow on a base of $1.1, $1.2 billion in FY '28.

That's clear. 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 US sales perspective?

Yeah. Multiple products across, I'd say, biosimilars, injectables, as well as respiratory.

On the, I'd say biosimilars and injectables—there's a lot of disturbance on this line.

Damayanti, you might like to mute yourself.

Thank you. As I was saying, that multiple products in the biosimilars, injectables, and respiratory front over the next couple of years.

In fiscal year '27 itself, we have yet to launch pegfilgrastim, that is going to be a H2 product for us, will be expected to contribute very nicely into the second half. Then we have a 505(b)(2) to dalbavancin injectable that is going to be a good-sized product for ourselves as well, and nasal sprays like fluticasone nasal spray, as well as injectables: sugammadex, epinephrine, raltegravir where we're exclusive first-to-file, ertapenem injection, which is all fiscal year '27.

Then fiscal year '28, we have products like, I think full-year impact of pegfilgrastim. We have diazepam nasal spray.

We have 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 looking fairly interesting for us. Then iron sucrose injectable, Saxenda.

We have ivacaftor, exclusive first-to-file; midazolam nasal spray; and there are just 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 fiscal year '28.

Then I'd say that in fiscal year '29, we should have more biosimilars: aflibercept, pegfilgrastim on-body, Dulera is expected, hopefully we can get it in fiscal year '28, but if not, for certain in fiscal year '29 on the market. Depending on what transpires from a P4 standpoint, we would expect also Spiriva Respimat.

We 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 fiscal year '29.

Elaborate answer on this. My last question is when you look at the tiotropium market share, it has been hovering around mid-30s.

Do you have room to improve it further? If you can talk a bit about your progress in the channel, in the incremental channels for this product?

Thank you.

No, it's kind of settled at that 38% level. There is a good balance between what the brand has in terms of share and what we have in terms of market share.

At this point, it should hover around that level.

Hello, Damayanti, you can unmute yourself.

I'll get back in the queue. I'm done with my questions.

Thank you. Thank you for your question.

We'll take the next question from Shyam Srinivasan.

Hi, good evening. Thank you for taking my question.

Shyam, are you there?

Yeah. Can you hear me now?

Yes, we can.

Yeah. Just trying to do math on your US guidance, right?

We did $366 million this quarter. You talked about $1.1 to $1.2 billion for the full year.

That brings us roughly $100 million lower per quarter in some of the quarters, right? I'm doing simple math—$250 and $280 million roughly, right?

What is that big step-down? Is it both the top 2 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?

Yeah. 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 4 players market with tolvaptan.

We expect the market to grow as well for the molecule, given that it is still 40% generic conversion so far. Given the additional competition, we expect pricing to come down, and obviously also some share redistribution.

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 full quarter impact from Q2 onwards.

We expect revenues to be anywhere between $250 to $280 million a quarter over the next couple of quarters.

Got it, Vinita. Thank you.

When I look at your full-year margin guidance of whatever, 25%, we did the gross margins of 75% for the current quarter, right? 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. More importantly, the impact of price increases that we have seen in the recent past that post the cost increase that is because of the geopolitical tensions around.

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. I think we are being a little more cautious when we 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 of on the gross margins front as well.

Got it. Thank you, Ramesh.

All the best.

Thanks, Shyam. We'll take the next question from Neha Manpuria.

Thanks for taking my question. Vinita, in tolvaptan, we have seen a quarter-on-quarter increase in market share.

Would that be a fair assumption?

Yes.

I think in one of your previous calls you had 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, the tail to be longer because of the fact that it's a specialty, pharmacy product, as well as REMS program. We obviously have will have to give some share as well to the additional entrants.

Understood. On apixaban, how should we think about the opportunity?

I know 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 '28?

Yes, we are looking at the different channels for the product. It's a very large brand, which makes it a very interesting opportunity.

Given the time we have prior to the other generics entering the market in fiscal year '29, we believe that a very targeted approach around a few channels is going to serve us well. We're looking at ways and means of entering a few of the larger channels where we can, through our national accounts efforts, as well as some incremental commercial efforts, be able to get strong access.

Understood. Do you think this should be as large as probably Mira and tolvaptan was for us?

Could this be as large, in your view?

It could potentially get there. Yeah.

Okay. Last question on biosimilars.

Let's take a 3-year time frame because you have a couple of launches coming in '29, how big can the biosimilars space be for us here as well as in Europe put together?

Put together, it's a material opportunity for us. The US itself, of course, we have to deliver this here, but it's looking like a very interesting opportunity with pegfilgrastim.

Ranibizumab, we'll have to convert the market. 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 Visupharma footprint that we have across the ophthalmology call point, we're going to leverage that as well for ranibizumab.

Then we have aflibercept coming in fiscal year '29, and the pegfilgrastim OBI, and then fiscal year '30 of course, is a calendar '29 will have etanercept. I think we're looking at biosimilars ramping up in the next 3 years to a couple of hundred million dollar scale business across these key markets.

Thank you so much, Vinita. That's very helpful.

Thank you, Neha. We'll take the next question from Surya Patra.

Hello, Surya.

Hello, am I audible?

Yeah.

Thanks for the opportunity, ma'am. See, my first question is on the respiratory portfolio.

See, how big is the respiratory portfolio's contribution to the overall business for Lupin right now? In terms of the US business, if you see, what would be its share currently, ma'am?

In the base business, I'm just going on memory here, it's over 20% right now, with really 2 main products, tiotropium as well as tiotropium—

Albuterol.

Albuterol as well as Xopenex. A little bit more than 20% even.

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've made significant progress over the last quarter, and we are in a position to file this fiscal year.

We also have been successful with the pivotal PK on Breo, very pleased to get the Ellipta franchise also started from 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.

Really pleased with the progress now that we're making on the respiratory pipeline, both with MDIs, DPIs, Respimat, Ellipta, as well as MDI products and green propellants.

Sure. In fact, from the albuterol side, the market share which has to some extent subsided from the level of 19%, 20% to 16% currently, and possibly we have already reached the peak potential of the tiotropium.

Here in the mid-term, till the time that the pipeline product are getting launched in the US, whether it is fair to believe that the respiratory portfolio in the US is likely to remain flatish or kind of moderating, like that?

Also, hard to predict for certain, but right now the albuterol market has stabilized. It has this 16% share and the relative positions of competition have kind of stabilized based on the supply situations with different competitors.

On tiotropium, we know how difficult it has been for us, we haven't really heard of any imminent approvals and launches, we would expect that the baseline should be stable as Dulera, our nasal spray products in the next year, and then the new products, Respimat as well as others, come to market.

Sure, ma'am. My next question is on the Europe business, which has been doing great for us and that is visible even in this quarter.

Just going through the kind of a higher rebate policy initiated by Germany, wherein they are kind of doubling the rebate requirement. Given that, what would be your reading about the either profitability or the 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 overall Europe portfolio that can see because of this?

Yes,

it's very interesting, the dynamics in all of the European countries that we are realizing. 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're finding that is not part of the AOK tenders anymore, it becomes a nice branded opportunity.

Overall, we're seeing all of the major European markets really struggling with the overall healthcare budgets, their overall drug spend 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're starting to see in countries like France, we have recently noticed that they are really doubling down on biosimilars, just given how important the biologics LOE is, right now it's like $100-plus billion worth of biosimilars that go off-patent over the next 5 to 10 years.

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. 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, the biosimilar side of the business more substitutable to be able to get efficient access to medicines.

We actually 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 on overall as well as the ophthalmology biosimilars, as well as the specialty portfolio. We have tremendous headroom to be able to build in Europe.

Sure, ma'am. Just last one question from my side regards the biosimilars, 2 points specifically here.

How important and or, let's say, how sizeable this 2 opportunity, first 2 product opportunity in US for us, because pegfil or even the 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%? Considering that, how sizeable this could be, that is the first point.

Secondly, given the kind of a price erosion sharp that has happened already in the US market, how is the European product prices there in biosimilars compared to that of the US?

We're finding actually even with pegfilgrastim, as I mentioned earlier also 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 confidence operationally. As we look at our partners' forecast and what we can do in the current fiscal year, it's a really good-sized opportunity for Lupin.

As I mentioned, I will not size up each and every product, but if I look at the next 3 years between US and Europe with these 3 or 3 products or so, we have a couple of hundred million dollars' worth of opportunity on the biosimilars front.

Price difference in US and Europe?

In Europe, we have found the pricing on our products is fairly stable. Like I mentioned, we're also starting to see new developments, like in Germany, these products are not part of tenders, 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 that gives us this optimism on the biosimilars front.

Sure. Thank you, ma'am.

Wish you all the best.

Thank you.

Thanks, Surya. We'll take the next question from Bino Pathiparampil.

Bino,

you can unmute. Yeah.

Hi. Good morning and good evening.

Vinita, just a follow-up question on a couple of products which you mentioned. You mentioned a first-to-file exclusivity in FY '27.

I didn't get the name, but is that a sole exclusivity?

On raltegravir, yes, I mentioned that.

Sorry, which one?

Yeah.

Raltegravir.

Okay. Second, in FY '28, which is the one you mentioned as sole exclusivity?

I think I mentioned diazepam, epinephrine, Epi, that is 2 nasal sprays, ivacaftor is another, and yeah, those would be the main ones. Cinvaf is another, exclusive first-to-file next year.

Got it. Last question on Spiriva Respimat, how is the market compared to the DPI?

It's moved more towards Respimat.

Okay. If you could give some rough size idea?

We'll just get back to you with that. I don't have the exact numbers off the top of my head.

Great. Thank you.

I'll jump back to queue.

Yeah.

Thank you, Bino. We'll take the next question from Kunal Dhamesha.

Hi, thank you for the opportunity. The first question is on the India business that you shared that we are planning to derive 1/3 of the revenue from innovative products.

Can you elaborate more on this strategy? What would be the kind of required investment here, both from balance sheet and P&L perspective?

The usual impression is such in-licensing deals are not very accretive to profitability, right? What are we going to do differently?

From therapy perspective, do we stick to our key therapies of cardiac, antidiabetic, or we look at a more high-growth therapies like oncology? That would be the first question.

Sure.

I think there's 3 avenues of proprietary products. One is our internal pipeline, we're building those internally.

Another is in-licensing deals as you talked. The other, the 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.

We've allocated the capital for this. It's actually, just purely India is not that expensive from overall licensing or a development perspective.

Obviously, you need to have the entire suite of capabilities, you do need to have the ability to assess a new chemical entity at an early stage, do the clinical development, and bring it to market. In a market like India, how do you build the ability to do, over a period of time, 30, 40, 50 assets at a time.

The goal of $1 billion, our 1/3 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, 15 products every year, and I think it's coming together quite well. In the next 3 years, we should start bringing those products to market and really build that pipeline.

Obviously, key interest would be in our key therapy areas, which have proprietary products in respiratory, in cardiology, in diabetes. From a innovation perspective, obviously, 50% of what you would see as assets would be in areas like oncology, where we're not strong.

There 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. Sure.

We are suggesting like 80 launches in India in the next 3 years, right? How many of that you think would be from this bucket?

Over a period of the next 10 years, we're looking at 60 to 70 launches of the innovative products. In the next 3 years, very small fraction.

I would say not even 3, 4 of these would be truly innovative products. Sure.

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, actually. We would expect that.

I think you've already pointed to the point on how much is the actual burn on the clinical trial part, and all. I think the entire model looks really good, and in the next few years, you'll start seeing positive returns coming from it.

Sure. The next question for Vinita ma'am.

Given that we have now established track record of selling both DPI, MDI products in US, how is it helping us in terms of clearing or 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 next wave of products to the market efficiently?

I'd say that 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 this year.

I'd say on the Ellipta platform, that was likely our most challenging platform. We've been working on it for multiple years, and very pleased to finally be able to get a positive PK on the first product.

Now would want to get the next major is getting Trelegy right, which our team is working upon and they're going to apply the learnings they have from Breo onto that product. Then on the Spiriva front, on the Respimat Spiriva, that was more of a device challenge that we faced that now that we have cleared it and will file the product this year, the follow-on products become easier for us.

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 that, given that these products are either CGT or have no competition in the marketplace, the FDA is also looking to expedite these approvals. Going to look forward to leveraging that.

In addition to that, a number of these products, some are out of India, some are out of our facility in Coral Springs. We'll also want to leverage the Coral Springs domestic manufacturing in the US for expedited review of these products that the administration has focused on to get more onshoring of products in the US.

Ma'am,

just one aspect of this. Let's say if you have an MDI line for one product, the capacity becomes fungible for another MDI, or it does not?

It does.

It does. Okay.

Great. Lastly, on the apixaban 505(b)(2), from here, what are the key monitorables for you, and what's the duration advantage that we will have vis-à-vis the generics, I think which are slated to enter early part of FY '29, I believe?

Fiscal year '29. We are, as I mentioned, we're sizing it up, but like material brand, so, we'll be 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 simultaneously, we're building up launch quantities, and we expect to start having material, commercial quantities start in January of 2027 calendar.

We would expect somewhere in the summer that we should launch, and hopefully get 10 to 12 months before others enter.

Okay. Lastly, can you share which plant is it filed from?

Kunal, can we request you to get back in the queue?

Sure, sure. Yes, sir.

Thanks.

I'll just quickly respond to that, though. It's Somerset.

Please, please.

Perfect.

That's been cleared recently.

Yes. Thank you, and all the best.

Thank you.

Thank you, Kunal. We'll take the next question from Tushar Manudhane.

Hello. Thanks for the opportunity.

Ma'am, in the opening remarks, you alluded to fluticasone nasal spray. Which dosage have we filed, and where are we in terms of the approval process?

Yes, we've filed both the Rx as well as OTC. We would expect the Rx approval to come in this year, and OTC in the next year, fiscal year '28.

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

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

The devices from the—

In-house.

Oh, device is also in-house.

No, we chose the device, of course, through a device manufacturer.

Got it. Thanks.

It's also in Somerset.

Thank you. Thank you, Tushar.

We'll take the— Yeah. Pardon me.

Hello. Tushar, are you there?

Please,

please.

Yes, I am there. Just one more question, if I may.

Ma'am, you referred to apixaban 505(b)(2), right?

That's 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 is?

Maybe share that closer to the launch date.

Okay.

Yeah. We're sizing up the opportunity and will be in a better position to share that over the next couple of quarters.

Sure,

sure. I was trying to just 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.

Right. It definitely would meet a unmet need for patients that we have targeted, but let us come back to you with thoughts around it over the next couple of quarters.

Sure, ma'am. That's it from my side.

Thanks, thanks a lot for all responses.

Thank you, Tushar. We'll take the next question from Vivek Agrawal.

Hello, Vivek.

Hello.

Yeah. Can hear you.

Thanks. Just couple of questions on the cost base.

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

The cost lines essentially because of increments, they're of course based again on the needs of business, including India region. We have also been recruiting people and the like, and there's also an FX impact at least vis-à-vis the previous year.

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

Is that a possibility?

There would be volatility between quarters for sure. The magnitude is something that we can't actually speak about at this stage.

You would also do well to understand that our R&D expenditure is at least a tad above the competition, firstly. Secondly, we also have the impact of adjacencies and so on, which are being captured.

They're still evolving. Some of them are still making losses, which, 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'll be breaking even for sure. I would say the same thing of other businesses, our digital business is evolving extremely well.

You could say that of the OTC business as well, and CDMO. I think you would do well to remember that all of these are at this stage loss-making, and therefore is impacting our EBITDA margins, and of course our overall EPS at this stage.

Clearly that would be a thing of the past in quarters to come.

Understood. 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 a percentage, percentage and a half, I would say.

Understood. One question, one product-specific question I have.

You have a one product, one FTF, that Xywav. Is it a FY '29, '30 type of product, or is it FY '30 or beyond?

It's a FY '33 product for us.

Understood. Thank you, that's from my side.

Thank you so much, Vivek. We'll take the next question from Saurabh Kapadia.

Hello, Saurabh, are you—

Yeah. Thanks for the opportunity.

Just one question on the other developed market and EMEA. What could be the sustainable growth in this market over next couple of years?

Secondly, with the kind of growth we are seeing, how the profitability or the margins in the key market have moved over last 3, 4 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. The margins also, just given the scale of the business is growing, we've been subscale in so far, and with the additional portfolio as well as the expansion with the pipeline, we expect margins to continue to expand as well.

Okay. Just secondly, do we need incremental investment to be made in any of this geography, or any potential inorganic opportunity which we could seek in any of these specific countries?

Yes, we would expect for us to really maximize the biosimilars business, we are going to make small, but commercial investment, in particular in the US, 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 as well.

Okay. Thank you.

Welcome.

Thank you, Saurabh. We'll take the next, one last question from Chintan Sheth.

Hi. Am I audible?

Yes.

Thank you. Thank you for the opportunity.

I have a question on the US side of the business where we have put out the numbers in terms of upcoming pipeline of 50 FTFs, 21 exclusives ones. If you can—I know product-specific will be very hard for you to provide, but 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 3 3 to 5 years, as you've explained few of the products already, but if you can cumulatively help us understand how should those numbers can contribute to our incremental revenue in the US market?

Perhaps what we can do is get back to you offline to take you through the overall brand revenues and the relative products where we have limited competition. Overall, we're looking at our portfolio from the complex generics doubling over the next 3 to 5 years, and that in itself, along with the fact that we believe, with the pipeline we have, we should be able to grow our business in the next 3 to 5 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 maximize these opportunities.

Maybe our team can get back to you offline on looking at the overall market size and the like.

Got it. On the EMEA side and I believe the growth is coming because of the Visupharma acquisition for the last 4 quarters, base of Q2 kind of bakes in the Visupharma.

How should one look at the growth in that piece, EMEA business going forward?

Like I mentioned that we're looking at anywhere from 10% to 20% level in Europe, splitting out Africa, South Africa separately. It's a little bit lower in South Africa, just given the scale we are at.

With the pipeline portfolio that we have and the opportunities, Europe should grow at that 10% to 20% level.

Got it. RoW markets, any color on the growth?

Also the double-digit growth.

To continue.

Yes.

Got it. I'll kind of touch base with the team offline to understand the pipeline better.

Yeah.

Thank you.

Thank you. That's all from my end.

Thank you, Chintan. 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. If not, the team will connect and clarify any open questions you have.

We, as I mentioned, are optimistic about our near-term opportunity, as well as long-term opportunity, both in the near term to be able to navigate the 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 in India, innovation in our specialty business in Europe as well as the US, 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.

Thank you, ma'am. Thank you, sir.

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

Thank you.