Welcome to Lupin Limited Q3 FY 2026 Earnings Conference Call. Thank you for your participation on the call today. Please note that all participants' line will be in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks. Please also note that this conference is on recording mode. I now hand over the conference to the management. Thank you, and over to you.
Good evening, everyone, and thank you for joining us. I'm pleased to welcome you to our Q3 Fiscal Year 2026 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 revenue surpassing last quarter's record performance. This marks our 14th consecutive quarter of year-on-year growth. While the U.S. 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 U.S., where we recorded the highest sales in the region so far. Exclusivity.
Our first product from the proprietary Nanomi long-acting injectables milestone this quarter was the successful U.S. FDA inspection of a biologics facility in Pune, followed by the approval of pegfilgrastim.
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So, an important milestone was the successful U.S. FDA inspection of our facility in Pune, pegfilgrastim, our first biosimilar for the U.S. market. We have entered into an exclusive licensing agreement [inaudible] this quarter. See [inaudible] developments.
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Thank you.
Welcome, everyone. We are pleased to report another quarter of strong execution, with revenue surpassing last quarter's record performance. This marks our 14th consecutive quarter of year-over-year growth. While the U.S. 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-over-year growth. Turning to individual business segments, this quarter was a particularly strong one for us in the U.S., 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 Risperdal Consta with CGT exclusivity, first product from our proprietary Nanomi platform 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 U.S. FDA inspection of our biologics facility in Pune, followed by the approval of pegfilgrastim, our first biosimilar for the U.S. 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 U.S. 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 GIBTULIO and Ajaduo, domestic growth was 11.2% year-on-year for the nine months. Volume growth remains 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 1.4x and 1.6x 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 1.2x-1.3x , 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, 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 FY 2026 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 in the quarter came in at INR 7,168 crores, as compared to INR 5,768 crores in Q3 FY 2025 last year, a growth of 24% year-on-year. Among the key markets, the U.S. grew by 46% year-on-year. India grew 5.6% year-on-year.
Other developed markets have grown 11% year-on-year, and out- and emerging markets have grown 42% year-on-year during this quarter. Our GIB business grew by 7% year-on-year. The U.S. business. Coming to the U.S. business, this quarter, the U.S. business recorded sales of $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 U.S., which we expect to launch shortly.
We have a very exciting pipeline of products in this segment, which reinforces our growth prospects in the U.S. 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 FY 2026. For nine-month period, our prescription business has grown 9.4% against IPM growth of 9.3%. In fact, if you normalize 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 x and 1.3 x 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 FY 2026, 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 INR 812 crore, 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 by 42% year-on-year, with strong growth in Brazil, Mexico and Philippines, offsetting tempered performance in South Africa. Brazil has 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 INR 67 crore, as against INR 149 crore in Q3 FY 2025, and INR 216 crore in Q2 FY 2026, 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 FY 2026. 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 and 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 INR 1,143 crore, an increase of 16.1% year-on-year, from INR 984 crore in Q3 FY 2025, translating to 16.1% of sales, as compared to 17.5% in Q3 last year. This change is largely attributed to higher cost due to regular annual increments and business growth during the period. Manufacturing and other expenses. Q3 FY 2026 manufacturing other expenses came in at INR 1,137 crore, increasing 14.2% year-on-year from INR 1,696 crore in Q3 FY 2025. Translating to 27.3% of sales, versus 30.2% last year. The expenses were higher, mainly due to higher volumes in the normal course of business.
R&D at INR 535 crore is 7.5% of sales, as compared to INR 441 crore in Q3 last year, with almost 70% of our R&D spend directed towards complex portfolio. For the nine months ended FY 2026, R&D spend at INR 1,555 crore is 7.7% of sales. For the full year, as indicated, we expect R&D to be around 7.5%-8.5%. EBITDA. EBITDA, excluding Forex and other income during the quarter, was INR 2,210 crore, vis-à-vis INR 1,366 crore the same period last year.
An increase of 62% year-on-year, with a margin of 31.1%, vis-à-vis 24.3% last year the same period. An increase of 681 basis points over the last year. On a nine-month basis, EBITDA was INR 5,188 crore, an increase of 50% year-on-year, with margins of 29.8%, vis-à-vis 24% over the same period last year. We expect full year EBITDA margins to be in the range of 27%-28%, higher than our earlier guidance of 25%-26%. While 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 2026. For the full year, we expect ETR to be about 21%-22%. Operating working capital, which stands at INR 7,948 crore as of 31 st December, against INR 6,821 crore as of 31 st December 2025, which translates to 101 days of working capital, against 103 days in the previous quarter. Net cash. Net cash stood at INR 2,879 crore as against INR 310 crore as of 31 st March 2025.
While 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 a 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.
Thank you very much, sir. We'll 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 Nikhil Mathur.
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 U.S. outlook, let's say, in, going into FY 2029 as well. Now, obviously, with the Mirabegron settlement, it seems that Mirabegron should continue into FY 2027 and certain part of FY 2028 as well. But, ma'am, can you highlight what will be the drivers of the U.S. business once TOLVAPTAN and Mirabegron start tapering off? I believe you have. I mean, you have pegfilgrastim approval, we have talked about other respiratory assets.
So any help on, how should we look at launches, meaningful launches over the next two years, so that once Mirabegron and TOLVAPTAN come off, and you go back to a growth partner in the U.S., that would be helpful, any color on this?
Sure. Yeah, so, you know, we are 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. Maybe we have 35% share of that market, given that it's a specialty product. So we continue to build share on TOLVAPTAN. Having said that, you know, 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.
So as I look at, you know, the last couple of quarters, we've got approvals for injectable products like Glucagon, Liraglutide , Risperdal Consta , and with the pegfilgrastim approval getting into the biosimilars market as well to build the institutional business. So the institutional business will be a material build over the next three years, and we see it really ramping up very nicely over the next three to five years to be a material contributor to the U.S. business. Likewise, the biosimilar business, in particular, will also be a material contributor to the U.S. with pegfilgrastim, then ranibizumab that we hopefully will be able to launch in fiscal year 2027. And then the onbody pegfilgrastim, which is making good progress, and then aflibercept and etanercept in 2029, calendar 2029.
That will be actually fiscal year 2030. And then we have other products that we have planned as well, like mepolizumab, that are in the pipeline. So 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 2027, we will start our first 505(b)(2), and that's gonna ramp up in the next couple of years as a material contributor as well.
So, we have multiple growth drivers at this point for the organization, and feel fairly confident that, you know, we can, one, sustain this $1 billion+ revenue level over the next couple of years and build from there as we bring, you know, material, biosimilars, respiratory products, as well as, injectables, including the other first-to-file that we have in our portfolio to market.
Yep, so 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 FY 2027, in FY 2028 and 2029, the combined these three products, can they contribute, let's say, $100 million or round about that kind of a number in next two, three years, the combined, basket of these three products?
Yeah, the potential is there.
Understood. Also, I wanted to check on, you have tentative approval for this product, Xyrem. I guess the litigation is ongoing. Any probabilistic launch timing of this product? And I suppose Lupin could be sole FTF in this product?
Yeah, we are, we are exclusive first to file on that product. The launch date, I believe is fiscal year 2029, if I'm not mistaken.
Got it. Understood.
Yeah.
One final question I have on the India business. I think the Jan uary IQVIA data is showing good growth. Also last quarter, ex of the tender business, I think the growth has come in good. So are we in a good, let's say, 12%-13% growth environment for the company? And with all the vial issues in the base now and insulin tailwinds.
Yeah. So I think 20%-30% ahead of the market is what we would see ourselves at. The market is growing strong, so double-digit growth is assured, and I think not just for, you know, 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. So, lots of positive growth drivers for India.
Got it. This is helpful. Thank you so much.
Thanks, Nithin, for your question. We take the next question from Tushar Manudhane.
Yeah, thanks for the opportunity, and, congrats on the good set of numbers. So just on your comments on use of AI, so if you could elaborate which geography or which divisions have we sort of started implementing use of AI? And how faster or, or difficult, whichever way, the use of AI has been on the development side, on the manufacturing side?
Yeah. You know, we have made some good progress on AI, and this is across the entire company. We started off with the 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, you know. You know, over time, we've actually created several repositories, and it's important to actually bring everything together under one architectural roof, and that's it. That's exactly what we're trying to do at this stage.
But clearly, we have set our eyes on AI for all our functions, including finance, HR, legal, and procurement, and the like. And we expect a lot of these pilot projects that we've been working on to be kind of implemented over the next nine to 12 months.
Got it, sir. And secondly, the opening remarks also alluded to forming a new division for semaglutide with respect to catering to diabetologist, cardiologist, gastroenterologist. So how many MRs is like sort of getting focused for this particular product?
It's about 200 people, but I think we'll scale it up as needed.
So how do you see this? You know, 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. But , if you could, you know, throw, you know, your insights on this opportunities for India markets.
Yeah, and so I, I think many companies are gonna launch it. But the fact that we are 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. You know, 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. And, you know, again, as a large cardiometabolic player, it should be a nice opportunity. While we have created this division, we have the ability to scale up, we have the ability to add it into other divisions as well.
So, you know, I think it would be interesting. Let's see. I think it's just a month away.
Great. All the best. Thank you.
Thank you, Tushar. We'll take the next question from Bino Pathiparampil.
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. So why only $15 million provision?
Yeah, $15 million is essentially what relates to as the release, the past, while $75 million is linked to, in fact, future, you know, being in the market. So, clearly it relates to the future, and that's the reason why finally $15 million at this stage. The balance $35 million will be spread over the next, up to September 2027.
Okay. So that will come in other expenses later on in quarters?
It actually, you know, would not impact the EBITDA, because it's actually, you know, 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?
Well, so we have 40% generic share, and generics, you know, between us and Zydus, we also have 40% of the overall molecule. So, you know, 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. And why this end date of September 2027? Because the next Orange Book patent of Mirabegron expires only in 2030. So what prevents you from being exclusive in the market till then?
Till 2030, you mean?
Yeah.
Yeah, I believe.
Till the next patent expires.
Yeah, we believe majority of the settlements that the brand has, you know, that date in 2027, September 2027.
Oh, okay. One last question on TOLVAPTAN. How do you see the competitive scenario panning out? Why hasn't Apotex launched till now, and do you expect more approvals?
We're not certain why they haven't launched. You know, 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, you know, Teva's approval. And then we know that other competitors have November 2026, 30-month stay date and into 2027.
Wow.
So we think that we, you know, if competition comes in, it's likely gonna be staggered.
Got it. One last, if I may, add in. Any update on Breo Ellipta in your pipeline?
Yeah, we're still making progress with the development. We were hoping to have it filed by now, but I'd say that it's still actively in, you know, our respiratory pipeline. We hope to really make material progress this calendar year.
Thank you. I'll jump back.
Thank you.
Thanks, Bino. We'll have the next question from Kunal Dhamesha.
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. So, we have this licensing outgo of $75 million, plus we have a per unit licensing fees that we'll pay, right? So, are those separate? Are those same thing? How to think about that?
They're separate.
It-
Can you still hear us?
Right, would it take a knock from the revenue, or?
You know, your
Kunal, can you repeat your question, please?
We can't hear you.
Can you hear me now?
Yes.
Yes.
Yeah. So, so 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, you know, the overall operating profit, and there's an element which will actually get amortized over a period of time. So both will actually hit the P&L.
Okay. One above EBITDA, one below EBITDA?
Yeah.
Then, 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. And, second question on the overall profitability outlook, let's say beyond FY 2026. I think earlier we had suggested for FY 2027, EBITDA margin range of around 24%-25%. So how do we think that is going to play out now, with the kind of products that we have in U.Sl and India, et cetera?
So clearly, the top line buoyancy would continue. And, we, you know, we just mentioned about the fact that, Mirabegron will have a fresh lease of life, so to speak. TOLVAPTAN, we are not seeing competition, though, of course, we do expect that to enter at some point of time. And, Vinita alluded to a number of, new product launches, that could potentially happen next year. And there's semaglutide opportunities and, and the like, and of course, there are opportunities in emerging markets. So 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, you know, 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 we have as the current year because of sheer competition for some of the products, we still believe that, we'll be good for actually looking at 24%-25% next year.
Sure. And last one for Nilesh, sir, on the semaglutide generic launch. Bino, what is your expectation, let's say, from a year-one market perspective, how much it can grow? And did we allude to, you know, 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, INR 1,500 crore-odd opportunity in the first year.
Okay
And we talked about, you know, maybe doing INR 50 crore-INR 60 crore, something like that, in the first year. But 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? I mean, we've seen how Mounjaro went in the first five months since launch, right? So when this happens, the price point, what it means. And we want to be responsible, we want to do this the right way, you know, we don't want to just sell this for the heck of it. And so I think the intent would be to do it in as responsible a manner, but I think it, it should be a nice opportunity.
So supply wouldn't be an issue, let's say if we think about, you know, equitable market share or whatever we are currently having in cardio diabetic space. If we want to achieve that kind of market share, we are, we are 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, Kunal. Before we proceed, this is a gentle reminder to request all the participants to raise their hands from the Participants tab for more questions. Can we have Neha Manpuria for the next question, please?
Yeah, thanks for taking my question. Ramesh, on the 25% margin that you've mentioned for fiscal 2027, given that we have a fair bit of visibility on Mirabegron and also TOLVAPTAN, at least for, you know, next few quarters, how should I think about the cost, you know, other than the investment in the field force expansion that you talked about? You know, what should be the, you know, R&D increase or investments in other areas that you're looking at?
Yeah, clearly, you know, there is a lot of focus on costs, and whilst that will certainly continue, there would also be, you know, spends for R&D, which may increase, given the fact that we are focusing on a number of things out there. So, clearly, you know, combined with the fact that there will be some tapering off of, you know, top-line products, and the fact that you might have to provide for extra expenditure on the R&D, I'm just being conservative in saying about 24%-25% would be, you know, 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.
Okay, understood. And, Vinita, you called out seasonality as one of the factors for the strong growth that we saw in the U.S. Was that a meaningful contributor to the quarter-on-quarter improvement in the U.S. sales, or was a large part of that driven by TOLVAPTAN and Mirabegron?
No, TOLVAPTAN and Mirabegron certainly were the larger contributors, but even products like Albuterol, Tiotropium, oseltamivir have grown quarter-on-quarter.
Got it.
Because of the seasonality.
So that, that should normalize a little bit, right, as we go into the next two quarters?
Yes.
Okay, got it. Thank you so much.
Thanks.
Thanks, Neha. Can we reiterate our reminder to request all the participants to raise their hands from the tab? We'll wait for a few seconds for the queue to line up, please. Thank you. Go ahead. Hello. Yeah, can we have the next question from Shashank Krishnakumar?
Yeah, hi. Thanks for taking my question. Vinita, just want to get your thoughts around some of the recent regulations that we've seen around PBMs in the U.S. 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, and or could there be any change in terms of the industry mix, rebating levels, et cetera, which you probably foresee?
Sorry, I missed your question, the front end of your question. Can you repeat it?
Yeah. Yeah. So I just wanted your thoughts around the recent regulations around PBMs, which you have seen in the U.S.
Regulations around what?
PBM.
PBMs in the U.S.
Oh, PBMs.
Mm-hmm.
Okay.
Yeah.
Yeah.
Yeah, understanding is 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, might there be some meaningful changes in terms of industry dynamics or rebating levels, which you probably foresee?
Yeah, so the new administration has been focusing hard on the PBMs. And you know 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 you know 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 you know to the government, so that that benefit can be offered to the patients and consumers. So we really don't see a material change in pricing.
Got it. Thank you. And just a second one: How will you typically call out the growth figure for Europe? So if you would just share that for this quarter.
It was 11% growth.
Yeah. Got it. Thank you. That's it. Thank you.
Thank you, Shashank. Can we have the next question from Nikhil Mathur?
Yeah, thank you for the opportunity again. I just wanted to understand the injectable strategy, let's say from a two-year perspective. So I mean, great to have products like Glucagon and Risperdal Consta with those approvals and having been launched. But I suspect, I mean, none of these products would be big enough to kind of move the needle so much as far as the overall injectable sales is concerned. So how far are we from a big material launch on the injectable side? So 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 million-$200 million kind of a sales base on the injectables?
Over what time period can you achieve that?
Yeah. So apart from the products I mentioned, you know, 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, a smaller product. Just looking through the major products that Iron Sucrose will be a material one for us. And yeah, and more 505(b)(2)s that we haven't announced. But you know, we really see the injectables portfolio ramping up in the next three years to $100 million+. With a multiple, you know, the tens of millions of dollars in individual products, and then biosimilars adding to it.
Understood. And on pegfilgrastim, I mean, 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? I mean, some of the biosimilars are pretty well established for a number of years now. So what's the go-to-market strategy on pegfilgrastim now? And when do we start numbers showing up for Lupin in this product?
So we would launch this quarter, but you'll start seeing numbers really in the next fiscal year. And, we are, you know, very, encouraged with what we are hearing from the marketplace. You know, we have tied up with, this company with strong experts across the biosimilars market, from, you know, the McKesson and other, AmerisourceBergen and other, specialty, distribution, groups. And, we see a real place for, a new pegfilgrastim in the marketplace. So, you know, I'd, 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.
But just curious, I mean, with so many biosimilars in this product being already there, why would a ABC or a McKesson tie up with Lupin? I mean, is the cost going to be the proposition here? But if the cost comes off, would the margins be lucrative enough for you to make money on this product?
Yeah, typically, a new product is attractive from a reimbursement standpoint to the, you know, payers. So that itself will drive the initial uptick. And, beyond that, you know, 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. So we really see the market for biosimilars and for pegfilgrastim shifting. Also, we are the only truly integrated player, you know, with the India cost advantage. You know, having our own API, our own finished product. You know, the other companies don't have the advantage that we do.
Understood. Okay, got it. Okay, thank you.
Thanks, Nikhil. Can we have the next question from Kunal Dhamesha?
Uh.
Kunal.
Hi, good afternoon. So my question is on R&D spends. In the last couple of years, your R&D budget has gone from around INR 1,400 crores-INR 1,500 crores to around almost INR 2,100 crores now. So 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, you know, would come off also in the, you know, years ahead. So is there a chance that maybe after FY 2026 or 2027, your R&D, you know, starts going down also?
No, I wouldn't think so. Clearly, we are spending on the more complex stuff, you know, which includes the injectables piece, the inhalation piece. You know, any drug device combination always costs a lot of money with clinical trials and the like. And of course, we have our biosimilars. We've also always spoken about specialty ambitions and the like, so clearly, the spends would keep going up. But if our turnover keeps going up also, you know, as a percentage of sales, you know, 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.
So it is adding more projects overall.
Yeah. We're pivoting to more complex stuff, right?
Right. But then. Okay, let me put it this way: Is your budget on generics, the usual para threes and the para fours, I mean, the oral solids and all, is that the same, or even that is going up?
Actually, in absolute terms and percentage terms, it would be going down.
Mm-hmm.
It will-
Okay.
Yeah.
Okay, that, that's good to know. Second question again, you know, you have now a healthy cash balance, you are generating cash. So, you know, is specialty on your radar? And you know, exactly which therapies, in which markets would you be targeting?
I mean, so it has been on our radar, as we have shared in the past, and the therapy areas, also we've been, pretty vocal, you know, with the 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 U.S., and would like to get other products in, the therapy area. And third now is ophthalmology, where we have a start in Europe with VISUfarma , but we would like to get additional assets, both in Europe as well as, ideally U.S., Europe, and other developed markets.
So would you be more comfortable buying assets which have been approved, or the ones where you perhaps have to do a phase III trial, file it, and then, you know, commercialize it?
Yeah, so we've been looking across the board. I mean, of course, commercialized assets would be very lucrative, but they are far and few, because companies don't part with them easily. So, we're also looking at assets that are in phase III or have completed phase II successfully and, you know, 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-
TIOTROPIUM in China.
For the Chinese market?
Yes.
Yes.
Yes, I think it continues, not very meaningful.
Right. I mean, it's not meaningful now, or you don't expect it to be meaningful in future, too?
I mean, it's not in the market right now.
It's not approved.
Okay, okay. Got it. Thank you.
Yeah.
Thanks, Kunal. We'll take the next question from Bansi Desai.
Yeah, hi. Thanks for taking my question. So, the first question is on the overall biosimilar, you know, landscape in the U.S. We see recent, you know, developments which are all aimed at improving affordability and accessibility, you know, which is good, you know, structurally positive for us as well. But at the same time, it is also going to make market more competitive. So, how should we think about, you know, what will be those key factors which will, you know, determine our success? You mentioned about, you know, having that cost advantage, but I'm assuming, you know, a lot of Indian companies would have that. So that's number one. And the second is, we also see PBMs having their own brands or bringing their own labels, you know, in, in the space.
You know, that adds to the competition, right? How do you think about that relationship?
So I'll maybe take the second question first. You know, when it comes to the private labels, that's actually a avenue for us as well to gain share. When we see the Cordavis label, for example, you know, for Humira, that really drove significant share for Sandoz, we certainly see that as a positive for a biosimilar, you know? So, you know, what we are, we are starting to see is the block of the PBMs is actually going down. PBMs are, you know, are partnering now with biosimilars to gain, you know, to really bring access to biosimilars, you know, in the marketplace. So, that is one.
Second, I mean, we're very mindful of the fact that, with the market opening up, the regulatory requirements, you know, are becoming less burdensome, competition can increase. So, we are very selective in our portfolio, you know, shortlist. 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. And third, we also have a lens of the three therapy areas that we want to build in the specialty front, because we also, you know, are building commercial front end for the three areas that we can leverage across biosimilars as well as branded specialty products.
So we're kind of, you know, carving our own therapeutic area strategy as well on the biosimilars front. So all of those, you know, give us the confidence that we have. You know, we are not going after everything under the sun, you know, 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, you know, while you hear about the cost advantage of India, you know, across the generic drug companies, just look at how many biosimilar companies are out there. I mean, there are a handful of biosimilar companies at scale across the world, you know, between India, Europe, as well as Korea.
It's not the same level of competition as you see in the generic, you know, small molecule generic industry, which also makes biosimilars a more attractive area overall.
That's very helpful, ma'am. And also just a second question, you know, 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'd have made? You know, that's number one. And second, you know, with the settlement, you know, until September 2027, does it mean that, you know, we should not anticipate any generic players to come in this period, or they could come and settle, you know, with similar terms? That is, you know, paying royalty, et cetera, on, on the sales that they could do.
So, it's hard to predict what other generics will do. For us, it's given us certainty, right? I mean, we have no litigation burden anymore, no risk, and no impediment to sell the product in the marketplace. You know, we still look at it as a very attractive contributor to our P&L.
Mm-hmm. All right.
Thanks, Bansi. We'll take the next question from Vivek Agrawal. Hello, Vivek, are you there?
Hello.
Yeah, we can hear you.
Yeah, thanks. A couple of years back, you have highlighted that you are developing a product, it's a drug device combination called Nexplanon. So 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.
Yeah, it is in clinical development right now.
Okay, but, don't you think that's quite long, that is there still in the clinical development and all? So when you expect to file this product?
I believe it is planned to be filed in fiscal year 2028.
Fiscal year 2028, okay.
Yeah, it is a long development cycle, also pretty complex development.
Understood. Second question is related to India business, where I think you have done the business quite well in the last couple of years, and Rx business is doing phenomenally well, right? The confidence is also there. So just to understand, like, the next three to four 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 on sales force, et cetera. So that what gives you the confidence that you continue to grow this business? Thank you.
Yeah. So 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 you know, 65% of our revenues come from chronic side. We're doubling down. We added 900 people to our sales force in the last six months. So we're doubling down on the market. We have expanded into newer divisions, into newer therapy areas as well. And we haven't even done the innovation pipeline yet. I think that's something which has just started. In the next thre to four years, you'll start seeing more innovative products coming from our portfolio as well.
So 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, you know. And, you know, 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. And 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. So if you can prioritize, let's say, couple of, I think, top three areas where you want to spend money, let's say, in the next, three to four years. Thank you.
So clearly, we have the ability to borrow about $1.5 billion-$1.6 billion, so to speak, apart from, of course, what we have on our balance sheet in terms of cash already. You know, so from a purchase perspective, we would be looking at, in fact, specialty assets. You know, so, hitherto, we have been looking at, in fact, a critical, you know, something in the range of sweet spot being about $250 million-$300 million. We might up it a little more, based again on the proposition on the table, so 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. So we would, you know, invest only in so, in as much as the initial, you know, estimates were, so clearly that's again a threshold limit. And of course, we'd be interested in actually looking at assets in India. The sweet spot here again being about $250 million-$300 million.
Understood. So when you talk about specialty assets, right, is it mainly related to U.S., 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?
Yeah. So we are looking at US, Europe, developed markets, like the VISUfarma was Europe, right? And US as well. And as we mentioned earlier, we are looking at clinical stage assets, too. It will require investment before we bring it to the market.
Understood. Thanks. Thanks, that's from my side.
Maybe last two questions.
Yeah. Thanks, Vivek. We'll take the next question from Shyam Srinivasan.
Yeah, hi, good evening. Thank you for taking my question. Just, just to on, on VISUfarma again, I, 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, EUR 55 million was the annual expectation. So if you could just refresh those numbers, please. Thank you.
Yeah. So, we expect to close it in the next few weeks of this quarter, basically. So we'll start consolidating next quarter onwards. And, the revenue is very much still on track. I believe INR 60 billion +.
Close, yeah, a little more and for the next fiscal.
Yeah
But clearly for the numbers that you spoke about for this year.
Yeah.
Yeah. Sorry, Ramesh, euros or dollars? Sorry, just.
Euros. All of this is in euros.
Euros, euro million, right? Got it. And margin, I remember, was also high, 25% or 30%, if I remember right.
Eventually, based again on our cost synergies and all of that, we'll actually get to that level. It'll actually more.
But 21% to start.
Yeah.
Yeah.
Got it. Very helpful. Second question on emerging markets, is there a base effect on... We had, like, 40%+ growth. Any geographies to call out? Is it?
Mm.
Very-
Brazil, that we called out. You know, Brazil had almost doubled in the quarter.
Thanks to Dapagliflozin that we actually introduced out there.
Mm.
Of course, the lineup that we have for the future, that will kind of continue for some time.
Sorry, Ramesh, maybe constant currency growth, like, 40% seems odd. So is it, is it, like, local currencies? What are these growing at?
It actually nearly doubled in terms of turnover, given the fact that this product was a big hitter out there.
Got it. Got it. And lastly, on India growth, I know the 5.6% volume growth is nine-month. So what's the 11%?
No, no, no, 5.6 %.is actually taking into account the fact that we actually had a, you know,
No, nine-month volume growth. Yes.
Nine-month volume growth?
You're right, yes.
Yeah.
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 is chronic done? I think that, that's my last question.
Chronic has done extremely well.
Chronic has done well, and I want to say it's similar on the volume in Q3 as well.
Actually, the share of chronic has grown, gone up to 67%.
Yeah, volume 6.5%, and new products gave us 1.5%.
Mm-hmm.
Sorry, Nilesh, your voice is cutting. You, can you repeat it?
Volume growth was 6.5% for Q3, and it was 5.6 % for nine months.
Perfect. Thank you. Thank you, and all the best.
Thank you. Thank you so much, Shyam. Thank you very much for all your participation. I now hand the conference over to the management for the closing comments.
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, you know, specialty and complex platforms to enable us to grow sustainably over the next few years. So, thank you again for joining us, and we look forward to interacting with you in the next couple of months.
Thank you, ma'am. On behalf of Lupin Limited, that concludes this conference. Thank you for joining us, and you may now exit the webinar. Thank you.