Hello, friends. I'm very pleased to welcome you to our Q2 Fiscal Year 2026 earnings call. I have with me MD Nilesh, our CFO, Ramesh, and our Head of Investor Relations, Ravi. We look forward to sharing our Q2 highlights and outlook for the year ahead. We are truly delighted to announce our record quarter, with total revenue from operations and EBITDA exceeding INR 7,000 crores and INR 2,100 crores, respectively, for the first time in our history. Our margins have expanded by 750 basis points year-over-year and 470 basis points quarter-over-quarter, reaching 31.3%, the highest level recorded in the past many years. This exceptional performance reflects the consistent growth momentum we have sustained since the beginning of Fiscal Year 2023. Notably, Q2 Fiscal Year 2026 marks the 13th consecutive quarter of year-over-year growth, a testament to the strength and resilience of our business model.
Our top-line growth, combined with an unwavering focus on operational excellence and compliance across all geographies we serve, has built a robust and sustainable foundation for the future. This quarter's results were driven by broad-based growth across all our key markets: exceptional growth in the U.S., supported by continued exclusivity for Tolvaptan, strong momentum in India, and solid contributions from both developed and emerging markets. Coming to individual business segments, this quarter represented a notable achievement for our U.S. business, as we recorded one of our highest revenue figures to date. This was aided by new product launches like Tolvaptan, where we continued to enjoy first-to-file exclusivity, and also products like Mirabegron and generic Spiriva that offset low single-digit quarter-over-quarter price decline in base products, including Albuterol. We are particularly pleased to report successful approvals of several complex injectable products during the quarter.
Notably, we became the first Indian company to secure approval for generic Victoza, Risperidone's Long-Acting Injectable, the first approval from our Nanomi platform, and Glucagon, all of which further strengthen our portfolio of Complex Injectables for the U.S. market. In addition, we expect our biosimilars portfolio to start positively contributing to U.S. revenues from Fiscal Year 2027, and we target to have at least five products in the market by Fiscal Year 2030. We are very pleased with the market momentum on the biosimilars front in the recent past, with the FDA easing the clinical study and interchangeability requirements, as well as PBMs and potentially CMS starting to prioritize biosimilars. Altogether, this sets us on track to double the share of complex products in our U.S. business over the next few years.
In parallel, we continue to invest in expanding our specialty portfolio through a combination of organic initiatives and targeted acquisitions. Switching to India, revenues grew 3.4% year-over-year, with the core domestic formulations business delivering a healthy 8.8% growth, translating to 1.2x IPM growth. The overall Indian number was moderated by lower local tender sales within our global institutional business. Excluding the impact of loss of exclusivity on products like GIBTULIO and Ajaduo, domestic growth stood at a robust 10.7% year-over-year for H1. Volume growth remained strong at 5.2%, while the chronic segment now represents 65% of our portfolio, up from 64% last fiscal. Therapy-wise, GI grew 6x its category rate, while cardiac and respiratory grew 1.5x their respective category averages.
We remain confident that our India formulations business will continue to outperform the IPM by 1.2x-1.3 x, as we have stated in the past, supported by our 10,000+ strong sales force. With the revival of the respiratory category and the exit of Mixtard in the insulin market, we see near-term tailwinds for both our respiratory and diabetes portfolio. We have over 80 new product launches planned over the coming years, including innovative products from both in-house development and in-licensed. This includes GLP-1s, where we expect to be in the first wave of launches with semaglutide in India, and also are working on strengthening our innovation pipeline for the long term. Our other developed markets, including Europe, Canada, and Australia, delivered 19% year-over-year growth, with Europe as the standout performer, growing 26.8% year-over-year for Q2 and 27.3% H1.
These markets now represent 12% of total sales, up from 11% two years ago, and are expected to expand further as we roll out our robust pipeline of new products. The planned acquisition of VISUfarma, with its portfolio of 60+ innovative eye health products and established infrastructure, aligns well with our strategy to expand our European footprint and build a global specialty franchise. This acquisition, expected to close by the end of 2025, will enhance both growth and margins, adding diversity across key European markets. It will bring our global specialty business to $150 million annualized revenues next year, starting to build some scale. Our emerging markets grew an impressive 45% year-over-year, led by strong performance in Brazil and South Africa. We are especially pleased with the turnaround in Brazil, which grew 141% in local currency, driven by successful diabetes product launches.
Turning to R&D, our spend stood at 7.5% of sales this quarter, among the highest in the Indian pharma sector, reflecting our focus on complex and specialty platforms. We have over 50 product filings planned for the U.S., with a near-term focus on respiratory complex injectables and biosimilars. Over time, we expect an increasing share of R&D investments to flow into specialty programs and value-added medicines, including long-acting injectables, green propellant-based products, and 505(b)(2)s. We also plan to strengthen our innovation ecosystem in India through both in-house development and in-licensing of late-stage assets. On the compliance front, we recently received EIR status for our Pithampur Unit 3 respiratory facility, and are actively addressing the OAI at Unit 2. We remain fully committed to ensuring that all our sites adhere to the highest global quality and regulatory standards.
In conclusion, while we take pride in our strong results, we remain grounded in our long-term aspiration to build a company for the future, one that is resilient amid challenges, agile in seizing opportunities, and anchored in scientific innovation and patient trust. With a clear strategic roadmap, disciplined execution, and a deep sense of purpose, Lupin is well-positioned to deliver sustained value for all stakeholders in the years ahead. With this, I'll now hand it over to Ramesh for a deeper analysis of our financial performance.
Thank you, Vinita. Friends, I welcome you all to our Q2 FY 2026 earnings call. As you may have seen from the results, this has been a record quarter for the company, with the company recording its highest quarterly revenues and EBITDA. We delivered positive results on most key financial metrics, be it growth, gross and operating margins, earnings per share, or leverage ratios. As a result, our ROC is about 25% as at the end of Q2 FY 2026. Diving into the numbers, total revenues from operations, including other operating income for Q2 FY 2026, came in at INR 7,048 crores as compared to INR 5,670 crores in Q2 last year, a growth of 24% year-on-year. Amongst the key markets, the U.S. grew by 47% year-on-year. India grew 3.4% year-on-year.
Other developed markets have grown 19% year-on-year, and emerging markets have grown 45% year-on-year during this quarter. Our GIB business grew by 9% year-on-year. Speaking about the U.S. business, this quarter, the U.S. business recorded sales of $315 million, a growth of 41% year-on-year and 11.5% quarter-on-quarter on a constant currency basis, which is one of the highest achieved in this business. This growth has been due to new product launches, offset by low single-digit price decline in our base products, and anticipated impact of additional generic competition in Albuterol. We are pleased with the progress of our U.S. business, which continues to be a key growth driver. The recent launches in our respiratory and complex injectables portfolio, along with the anticipated entry of biosimilars next year, reinforces our complex generics portfolio, and we remain optimistic about growth in U.S.
Prospects in the years to come. Turning to India, the India region business grew by 3.4% year-on-year during the year. I'd like to highlight that the core prescription business grew by 8.8% year-on-year during Q2 FY 2026 and 8.7% in H1, handsomely outperforming the IPM growth by 1.2x and 1.1x, respectively. In fact, if you normalize for the loss of exclusivity on some of our diabetes products, the growth would have been 10.5% and 10.7% in Q2 and H1. Chronic share during the period was higher at 65%, with key segments like respiratory, cardiovascular, and GI significantly growing ahead of the industry. The share of in-licensed products is only 6% as compared to around 12% in FY 2025, which also has a positive impact on our profitability going ahead.
Other developed markets, insofar as other developed markets are concerned, revenues in our other developed markets was INR 812 crore, representing a growth of 19% year-on-year. This growth was led by a 27% year-on-year increase in Europe, due to higher sales in Germany and the U.K. from existing products and partnered sales. The recent announcement acquisition of VISUfarma will further add brilliancy to our growth in Europe going ahead. Other emerging markets grew by 45%, with strong growth in Brazil and South Africa, offsetting tempered performance in the Philippines. Getting onto the payroll, other operating income at INR 216 crore has increased by INR 40 crore as compared to Q2 FY 2025. This has been led by higher export benefits from the PLI scheme recorded this quarter.
Turning to the gross margins, gross margins continued their upward trajectory with Q2 FY 2026 at 73.3%, up from 69.3% in Q2 last year and up from 71.3% in Q1 FY 2026. This 403 basis points year-on-year improvement is driven by multiple factors, which includes better product mix, lowered share of in-licensed products, including higher profitability on loss of exclusivity products in India, increased volumes, and other cost improvements and efficiencies which have undertaken over the last several quarters. Employee benefit expenses at INR 1,106 crore increased 9.7% year-on-year from INR 1,007 crore in Q2 FY 2025, translating to 16.2% of sales as compared to 18.3% in Q2 last year. This change is largely attributable to higher costs due to regular annual increments and business growth during the period.
Q2 FY 2026 manufacturing and other expenses came in at INR 1,980 crores, increasing 18.8% year-on-year from INR 1,667 crores in Q2 FY 2025 and INR 1,772 crores in Q1 FY 2026, translating to 29% of sales versus 30.3% last year. The expenses are mainly higher due to higher volumes in the normal course of business and certain one-time acquisition-related charges. R&D at INR 509 crores is 7.5% of sales as compared to INR 448 crores in Q2 last year, with almost 70% of our R&D directed to its complex portfolio. For the full year, as indicated, we expect R&D to be around 7.5%-8.5%. Turning to the EBITDA, EBITDA including Forex and other income was INR 2,138 crores, we saw was INR 1,308 crores the same period last year, an increase of 63% year-on-year, with a margin of 31.3%, we saw was 23.8% last year in the same period.
On a quarter-on-quarter basis, margins have expanded by 470 basis points. This margin expansion is on the back of higher gross margins and a lower fixed cost. We expect full-year EBITDA margins to be in the range of 25%-26%, higher than our earlier guidance of 24%-25%. Whilst we expect business to continue to exhibit robust performance, overall margins in H2 would be tempered by higher R&D expense and a lower PLI income. Turning to the tax rate, the ETR is expected to be about 20.9% for H1. For the full year, we expect ETR to be around 21%-22%. Relating to working capital, operating working capital stands at INR 7,730 crores as of 30 September against INR 6,821 crores as of 31 March 2025, which translates to 102 days of working capital against 106 days in the previous quarter.
Net cash stood at INR 1,665 crores as against INR 310 crores on 31 March 2025. Whilst we focus on increased cash generation for our business, we would like to highlight that we continue to explore strategic allocation of our capital to address the long-term vision of the company, including on the specialty front. We have also announced planned investments in the U.S. at our Coral Springs site to cater to the anticipated increase in demand, especially for our respiratory products. On the ESG front, we reached a remarkable milestone with an S&P Global GSG score of 91 in 2025, reflecting a 15-point improvement over 2024. This achievement positions us not only as a leader in the pharmaceutical industry, but also amongst a very select group of global companies to surpass the 90 mark. This underscores our deep-rooted commitment to sustainability and responsible growth. 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 participants who wish to ask questions raise your hands on the participant tab on the screen. We will wait for 30 seconds for the Q2 assemble. Thank you.
Welcome back. The first question is from Kunal Dhamesha . Kunal, can you hear us? Hello?
Yeah, I can hear you now. Can you hear me?
Yeah, yeah. We can.
Good. Thank you for the opportunity and congratulations on a strong set of numbers. The first question on the U.S. business, now that we probably have seen a good amount of Tolvaptan in this quarter, how do we see this $315 million number moving in the coming quarters? Also, what are the key launches that we are looking at both in the second half of FY 2026 and the first half of FY 2027?
Yeah, so on Tolvaptan, we have 180-day exclusivity, so that's into next week, and we would expect some competition. We also believe that the two competitors that we are expecting, not both of them, may make it. The TAs are delayed. We do not see any TAs as of yet. We do think that we are going to get more of a runway. Plus, if we look at Tolvaptan conversion so far, we have seen 30% of the market convert. There is still a lot of room for generic penetration on an expansion of the market overall, both for us as well as new entrants. As we look at the next couple of quarters, the second half, we certainly think that we will have some erosion from this $315 million.
We should be close to between $275 million-$300 million per quarter to close over $1 billion, as we have guided in the past. In terms of new launches, just recently, we launched the authorized generic to Ravicti, which is a material launch for us. We are about to launch the Risperdal Consta product in the next couple of weeks. We have an upcoming goal date for Pegfilgrastim, for which we had a recent inspection at the biotech facility. Feel pretty good about that, so that should be coming up. Victoza was just launched, so we'll see the ramp-up of that. Injectables, certainly Ravicti plus biosimilars into the next couple of quarters, and then Ranibizumab next year. We feel pretty good about maintaining, sustaining a billion-dollar-plus level into fiscal year 2027.
Thank you for the color. The second one on the EBITDA margin guidance for FY 2026, which we have raised by almost around 100 basis points. How to look for the FY 2027? How should we kind of look forward to the EBITDA margin for the year?
Clearly, we expect a reduction in the second quarter, but we have also said in the same breadth that there would be an increase in the R&D expenditure. We do expect the R&D expenditure next year to kind of normalize a little, in fact, the second half. Given the fact that we expect at least some of the products to kind of sustain the momentum, we would think that we would be able to close at around 24%-25% next year as well. There are, of course, opportunities in other parts of the globe, like in India with semaglutide and the like. From a sales perspective, we think there would be growth, albeit it is going to be a little lackluster from a comparison perspective vis-à-vis the current year.
Overall, we would be able to kind of keep to the margins that we are speaking about.
Sure. Thank you. One last, if I may, in terms of the recent inspection at the Nagpur facility, have we submitted our response? How important is this facility for us from a future growth perspective, specifically from FY 2027 and FY 2028 perspective?
Sure. The audit was for our injectable facility. We have obviously submitted the response, and I think the next update, where we have made a lot more progress , actually goes in today. We feel, I think we are not happy with the observations, but we believe that they are addressable. We are obviously putting our best foot forward at this point of time with the response, and we hope that it will suffice. It is important, I think, both for our injectables, which we are just starting to build at this point of time, and some of our biotech products as well. The facility is important, and we want to keep it in a state of good compliance. Yeah, I mean, it is important, and we are going to do whatever it takes to get it to the finish line.
Can you share the number of ANDAs from the facility which are pending?
I mean, we've just started our injectable journey, so I think we've just got a few approvals, and we file five, six ANDAs every year. I mean, we're not talking about a very large number yet, but I mean, it's a key part of what we want to build going forward.
Thank you, and all the best.
Thank you.
Thanks, Kunal. We'll take the next question from Bino Pathiparampil . Bino, alias.
Hi, good evening and good morning. Congrats on a great set of numbers. To get an idea on Tolvaptan, could you compare quarter-over-quarter? Would 2Q Tolvaptan revenue be double of 1Q level or more than that, something like that?
Bino, we do not give product-wise guidance, but needless to say that Tolvaptan has been a significant contributor in Q2.
Okay. How is Mirabegron? Does it fluctuate quarterly, or are you maintaining a roughly same run rate?
No, Mirabegron has also grown quarter-over-quarter.
Okay. How do you think about that product? In February, there is this hearing. Do you expect a decision around March itself, or is it likely to go on for some time?
It is hard to predict how the judge will rule or the jury will rule. Based on the trial that we have seen so far, I mean, in the case of MSN that settled and assent last week, we feel pretty good about not really seeing any new entrants in the near term. As the trial date comes closer, we will see how the rest of the competitive base is going to really factor in the risk for the launches. We also feel good about the fact that our case, where we have a number of defenses on the non-infringement front, we feel pretty good about it as the trial comes closer.
Okay. Sorry, my question was specifically, once the trial starts in February, do you expect a final decision in your favor or against, whatever it is, within a month or so? Or is the trial likely to go on for months?
Usually, jury trials do not go on for months, but the decision from the jury is hard to predict if they are going to make the decision right away.
Understood. Okay. One last question on EMEA growth, very, very strong numbers growth, partly helped by currency depreciation, I assume, but even adjusted for that, it is very strong. Anything in particular that is driving that?
Luforbec continues to be a very strong performer. We continue to grow our share in Luforbec in the current countries where we are already present, as well as in new countries that we have launched. Raltegravir was also a good contributor to revenues in the quarter, so both respiratory as well as other products.
Got it. Thank you, I'll join back the queue .
Thanks. Thank you, Bino. The next question is from Shyam Srinivasan.
Yeah, good afternoon. Thank you for taking my question. Just one on the VISUfarma acquisition. If you could walk us through the strategic rationale. I think the presentation also talked about being accretive to margins. I can see some of the margins, but just the thought process on that acquisition, and what does it essentially add to our portfolio?
One, I mean, we have always said that we are underindexed in Europe, and we have significant potential headroom there, but did not have the right presence, market presence. We had presence in the U.K., Germany, and France very recently. This adds Italy and Spain to us. That is number one. With the infrastructure that we gain, we also have the ability to launch the Lupin portfolio into those countries, even though the business that we are acquiring is ophthalmics, right? With the infrastructure you get, especially the common resources, our team is also confident of launching other products into these markets direct as opposed to partnered business that we do in Italy and Spain-like countries. Second, ophthalmology as a specialty franchise is one that we have been excited about the last couple of years. We have been looking at multiple assets, both in the U.S. and Europe.
VISUfarma, we had gotten to know the company over the last couple of years and tracked them very closely and really liked the momentum that they had built, both on the commercial front as well as the pipeline front. It really sets us up very nicely to build ophthalmology franchise both in Europe as well as potentially the US and other developed markets going forward. Third, I would say that we have synergies on the pipeline portfolio from VISUfarma into other markets, in particular the emerging markets, Mexico, where we have an ophthalmic business, other countries in Latin America, Southeast Asia. We are looking at the potential also in countries like Canada and Australia. We intend to bring the VISUfarma portfolio to as many markets as we can.
A combination of expanding our footprint in Europe as well as building on the specialty franchise with ophthalmology and operating leverage through global maximization of portfolio.
Got it. Thank you, Vinita. Just double-clicking on your opening remarks, global specialty sales expected to reach $150 million. I'm assuming EUR 50 million actually comes from here. What is the rest of the things? I'm assuming some of it is in the US as well. If you could walk us through that as well. Thank you.
Yeah. So we have Xopenex in the US. That is one brand in the US right now. We hope to be able to build on that. We have ZAXINE in Canada for IBS, and we have NaMuscla in Europe.
Got it. The time frame for this $150 million would be fiscal 2027, is it, or later?
That's right.
Okay. Got it. Thank you. Thank you, and all the best.
Thank you, Shyam. Before we move on to the next question, there's a reminder to request all the participants to raise their hands from the participants tab. Thank you so much. We'll take the next question from Saion Mukherjee.
Yeah, thanks for taking my question. We have seen very strong growth in some of the emerging markets like Brazil, South Africa, you mentioned, and also in Europe. How should we think about the growth? Because the numbers are very high. Is this number sustainable? First, and on this basis, how should we think about growth if you can take us through in these markets, and what will drive that?
Europe in particular, I mean, we have a pretty strong portfolio pipeline of products for the next few years to drive growth. We would love to grow 20% plus every year, but I'd say at least on a three- to five-year basis, we should see higher than the company average growth rate in countries in Europe, facilitated now with the VISUfarma acquisition as well. In Latin America, Brazil in particular, it really has been a turnaround aided by a really good product launch in the diabetes franchise, Dapagliflozin, as well as this week we got approval for Empagliflozin. We are hopeful to be able to drive growth in Brazil on the diabetes franchise overall. South Africa, we've really turned around the business again. It was flat over a couple of years. We have restructured the portfolio.
We have doubled down on products where we see potential of growth going forward, and are hoping to sustain the growth rate that we have in the current year in the next few years ahead.
When you all put together, you're expecting double-digit constant currency growth across all these key markets?
Yes.
Okay. Okay. My second question would be on biosimilars and respiratory. If you can take us through the key milestone that we need to watch out for. You mentioned five products commercialization in biosimilar till fiscal 2030. If you can take us through the products and timeline, and also on the key respiratory filings where we are and what's the time frame for commercialization?
Yes. On the biosimilars front, Pegfilgrastim is in the next couple of weeks, I'd say. We have a goal date in the end of this month. That would be our first one. We have Ranibizumab middle of next year, the goal date, and feel pretty good about that one because I think we are the first prefilled syringe filed in the U.S. Also, currently, the two biosimilars that were on the market are out of the market, presumably because of pricing concerns and probably will come in with a different price point. That presents a really nice opportunity. We have the on-body product, Pegfilgrastim, that we have made progress on, and we'll expect that to be third to market. Fourth will be Eylea, building on the ophthalmic after the Ranibizumab launch.
The fifth will be Etanercept, our first biosimilar that, because of the submarine patent in the U.S., is out to 2029. We will expect to launch Etanercept as well in the five-year time frame. Those are the kind of the products on the biosimilars front. On the respiratory front, we are making progress on DULERA that we have already filed. We are pretty far along now on Respimat with the Spiriva Respimat product and hope to really, by the end of this fiscal year, provide more of an update there on the concrete dates from a filing perspective. We are also making progress on the Ellipta franchise with Breo, Trelegy as well, and Anoro. All three products are in development.
We have made substantial progress on the green propellant front, especially for Europe, where with Luforbec, the green Luforbec is an important part of our five-year plan in the European markets, plus Trimbo. We have actively under development, as well as other US products. We have green propellant versions in development as well that gave us an opportunity to quasi-brand them, figure out if we can position them in between generic as well as proprietary brands.
Okay. Just one clarification, Vinita. I mean, all these products that you mentioned, should we expect filings in FY 2027? That is next fiscal year.
Maybe not all of them, but at least a good percentage of them.
Okay. Thank you. I'll join. Thanks.
Yeah.
Thank you, Saion. We'll take the next question from Neha Manpuria.
Yeah. Thanks for taking my question. Ramesh, on gross margins, how should I look at it, given we had a lot of moving parts and benefits in this quarter? From a full-year perspective, based on what happens to Tolvaptan, what should be a reasonable assumption for gross margin levels?
This particular quarter, there was essentially a Tolvaptan factor and also because of the fact that loss of exclusivity on a couple of products in India. Once it turns generic, clearly, margins also increase because the margin percentage increases. That is the story insofar as this current quarter is concerned. Clearly, we're working on a number of initiatives in terms of alternate vendor development and stuff like that in terms of wanting to move the gross margin line. There could be a decline. Having said that, if you're guiding for, in fact, the EBITDA margins being around the 24%-25% mark, this obviously takes into account the fact that there could be a slight reduction in the gross margins line, but made up in some ways through operating leverage and other parts.
Understood. Vinita, on biosimilars, something like, let's say, Pegfilgrastim, which is already a competitive market, Ranibizumab, you yourself said that we've seen players exit because of pricing. What do you think of how does Lupin see itself positioning competitively to gain market share there? From a commercial front-end aspect, do we need to spend incrementally to get that infrastructure in place in the next year for Ranibizumab and Pegfilgrastim? In your assessment, what could be the cost for that?
Yeah. On Pegfilgrastim, actually, there's been a lot of interest from partners that are in the oncology space already. Just given the dynamics of the biosimilars market, where a new product coming in, even after multiple competitors, can set a reasonable ASP, we see tremendous opportunity. In terms of share, certainly, it's going to be a smaller percentage compared to other products where we'll have a limited number of players. In terms of dollars, it should be a nice contributor into the next couple of years, fiscal year 2027 as well as 2028. Pegfilgrastim, in particular, we have planned to partner. We're not going to build any commercial infrastructure.
On the ophthalmic front with Ranibizumab, where again, we see an opportunity of launching at a reasonable price, I'd say, that gives room both for the providers as well as for us as a manufacturer, we expect to have some infrastructure to be able to sell through to the ophthalmic distributors and also ensure that we get the fulfillment. Given the fact that we have two biosimilar products, both Ranibizumab and Eylea, we're going to make not a material, but a small investment in a commercial team that can position the products.
You should have muted. We can move on. Neha, are you there?
Yeah. Sorry. I was on mute. What would be the timelines for Eylea, Vinita?
Eylea is fiscal year 2028 or 2029. I think it's at the tail end of 2028, early 2029.
Okay. Understood. From capital allocation, I think in the opening remarks, there was a mention of investing more in specialty. Given the investments we have in ophthalmology with VISUfarma and also separately NaMuscla, in CNS, will this be the two areas that we would focus on for incremental deals in specialty? Would that be the road we would go down to, or you're open to looking at other therapy areas as well?
We are focused on three therapy areas. Respiratory continues to be a focus just given the scale we have on respiratory, both US, Europe, other developed markets, as well as India. Second, NaMuscla, neurology, CNS is an area that we'll continue to build. So far, on that front, we are building on the DM indication. We are continuing to progress the clinical trial on the DM1 and DM2 indication for global, in particular, US and Europe commercialization. Ophthalmology is the third area that we have actually looked at in the past, but VISUfarma gives us a nice start, and we'll continue to build on the ophthalmology in US, Europe, as well as other parts of the world.
Understood. This was helpful. Thank you so much.
Thanks, Neha. This is to reiterate our request to all the participants to raise their hands from the participants tab for more questions. We'll wait for a few seconds for the queue to assemble. Thank you. Hello. Welcome back. We'll take the next question from Shashank Krishna kumar.
Thanks for taking my question. Just the first one on the respirator, which we plan to launch this quarter, wanted to check if this is a shared CGT exclusion?
We believe that we should be the next one in. Amneal, that has also got approval, will launch later. Yeah, we will have a shared exclusivity with them when they can launch, certainly when they get approved.
On Mirabegron, I think I missed your comments. Our base case is no incremental competition in the near term. Is that the right understanding?
No, base case is that we will have some competition. On Tolvaptan, did you say Mirabegron or Tolvaptan?
Mirabegron.
Sorry. Mirabegron, yes. Our base case is no additional in the near term.
Okay. Just a last one, if I could please. On DULERA, have we responded to the CR, or are we in the process of responding?
Yes, we have responded.
Thank you. That's very helpful.
Thanks, Shashank. We'll take the next question from Surya Patra. Surya, are you there?
Yeah. Yeah. Thank you for the opportunity. My first question is on the India business. Obviously, you have mentioned that excluding for the LOEs, the growth is really strong, better than the industry trend. When would we start seeing the normalized growth momentum or exclusive of the kind of impact that has been there so far?
Yeah. I think from the next quarter, so H2 onwards, you'll see stuff normalized. I think the entire effect of exclusivity and stuff is done. You'll see it from the next quarter.
In the meanwhile, I think the growth of the industry itself has muted. Do you think that is having some impact to the overall industry growth rate in the domestic market, and hence your growth may not be double-digit? Anything of that sort?
I mean, for H1, the market grew 8%. I would say that the industry is pretty decent from a growth perspective. From our perspective, we grew at 8.8% in Q2, 10+ % if I take out the LOE part. Again, our big therapy areas are growing strong double digits. And importantly, we're seeing strong volume growth as well. I'm cautiously optimistic on the market.
Okay. Okay. The second question is about the respiratory business. See, while there are multiple moments that we have witnessed, like moving parts within, one is that we have indicated about a long-term investment plan of around $250 million in the US. That is one. Simultaneously, we have also kind of adapted the Solstice propellant for our inhalers. Whether the Honeywell 's Solstice propellant for our inhalers, how is this changing the business opportunity or any competitiveness or the scope? If you can discuss that part also, if you can, that would be helpful.
Yeah. One, y'all addressed two different questions. First, on the investment in the US that we announced, the $250 million, a combination of both CapEx as well as pipeline, is for the Respimat as well as Ellipta franchise, which we have planned to commercialize from our US Coral Springs site. That is the investment in terms of pipeline, all the products on the Ellipta franchise, all the products on the Respimat franchise. Plus, we're going to have an MDI line as well that gives us access to government business in the US, also helps us diversify our risk a little bit on the MDI front with albuterol as well as other MDIs in the future. That was part of our plan already and has got very positive response from all the stakeholders in DC that we have talked to.
The fact that we are investing in the US has been received positively. On the green propellant front, we see a number of opportunities both in Europe as well as the US, maybe in the near term in Europe, but also in the long term in the US. You see the large majors like companies like GSK, AstraZeneca, as well as Chiesi in Europe, all have been working on low -GWP weight propellants, just given all the concerns of climate change. We expect that end of this year, we expect Ventolin to be filed with a new propellant in the US. There already have been multiple filings in Europe. We see it as an essential part of our strategy on the respiratory front to continue to sustain our growth on the respiratory franchise.
Plus, there's an opportunity also in products where the brand doesn't do it for us to differentiate ourselves. For example, in Xopenex, we are the brand, and we have the ability to bring a green propellant Xopenex on the market and differentiate ourselves and build the brand further. We look at it as a really nice opportunity to continue to grow the respiratory franchise in the U.S. and Europe.
Will it still have any implication on the albuterol franchise?
It'll be interesting to see how it plays out once Ventolin is filed and approved with the green propellant. We'll have to really closely track and monitor how the brand market evolves after these products are launched. I certainly think there's the potential to convert the market as there has been.
This is not compulsory as of now?
Sorry?
This is not a compulsory requirement as of now? You will be able to.
I think it is. I'd say that it's been emphasized more so in Europe. The U.K. has given a definitive date by which they are going to discontinue the high carbon footprint propellants, and Europe is going to follow that. I think the U.S. will be the third. I'd say the U.S. market will evolve very much dependent on how the brands position the new propellant products.
Just last one point on the VISUfarma.
Surya, can we request you to get back on the queue, please, if you don't mind? I mean, we'll have a lot of people.
That was my last question anyway.
Okay. Thanks. Sure. Go ahead.
Yeah. So my point was about the VISUfarma. What is the scope of cross-selling opportunity that we are having? And ophthalmology as an area, what is the kind of revenue mix that we are currently having for our entire global operation?
The revenue mix, I was pleasantly surprised, is actually $140 million when we combine VISUfarma plus India ophthalmology business plus Mexico, as well as a couple of other countries. After respiratory, it's becoming a therapy area of scale for us. The cross-selling potential we have across multiple regions, I mean, Latin America in particular, Mexico, other parts of Latin America, Southeast Asia, and Eastern Europe, as well as potentially in Canada and Australia.
Sure. Okay. Yeah. Thank you, ma'am. Wish you all the best.
Thank you.
Thanks, Surya. We'll take the next question from Vishal Manchanda.
Hi. Good evening, and thanks for the opportunity. Can you share whether you would have filed semaglutide in Brazil?
We haven't.
Okay. Second, on biosimilars, can you quantify as to what you would be annually spending on biosimilar development and other operating costs? Are we burning money there right now?
Yes, we are. We hope to be positive. Is this fiscal 2027?
Yeah. Yeah. The point also is that a lot of our products are in some ways partnered and the like. From that perspective, the overall burn is not that much.
Right. We should be positive in the next couple of years.
Even if we include the R&D that you do on biosimilars, your burn is not significant at this juncture?
Yeah. It is a negative, but it's not hugely negative.
Okay. Okay. Whether you would file these biosimilars in Europe too, or you are only focusing on the US?
No, both. US, Europe, as well as other countries.
Clearly.
Okay. Any sense on what capacities, so what market share would you be targeting with the capacities you would have created for these filings?
I think we have enough capacity to serve our share. But we're not taking on manufacturing business, CDMO business in a biologics facility, because we think that in the next five years, we'll fully utilize our capacity.
Okay. And you believe you have enough capacities for a fair share. Is that?
Yeah. For these products, for the current products.
Okay.
As we're looking at biosimilars going forward, given the momentum now, the FDA doing away with the requirement of clinical studies, certainly for products where we can be in the first wave where there are going to be limited competitors, we want to now target the next round of pipeline on the biosimilars front. We will have to really take a look at what we will need in terms of capacities going forward.
You won't be looking at the India markets?
We're absolutely looking at the India market as well.
Okay. Okay. Got it. Thank you.
Thanks, Vishal. The next question is from Damayanti Kerai?
Yeah. Hi. Thank you for the opportunity. My question is regarding Liraglutide. Vinita, how do you see this opportunity given market has clearly moved towards new gen products? Do you have more peptides which are in pipeline to be filed in the US in near term?
Yeah. We have just recently launched it. We are going to really, over the next couple of months, be able to determine what kind of market will the generic switch and also our own share. It has been a very recent launch for us. In terms of other peptides, we have semaglutide in the works. We have tirzepatide in the works. We have other peptides in the works as well.
Okay. And these are done through CMO, or you are doing in-house?
I mean, partially in-house. And we're also building our own capability on the peptide front. Just given the limited capacities available for peptides and the market expanding significantly, especially after semaglutide goes generic and starting next year in India and a few other markets. So we're building in-house capability.
Okay. That will likely come a bit late, right? In near term, it's more through CMOs, which.
That's right.
Yeah. Okay. My second question is actually clarification. Ramesh, did you mention for FY 2027 also, you will maintain EBITDA margin at 24%-25%?
Yeah. That's what I said. It would be obviously a tad lower than what it is today. Clearly, we think we would be able to maintain it between 24%-25%.
Okay. Thanks for clarification. Thank you.
Thanks, Damayanti. We'll take the next question from Tushar Manudhane. Tushar, are you there?
Am I audible?
Yes, yes, you are. Go ahead.
Thanks for the opportunity. Just on this Coral Springs investment, conceptually, Indian facilities is at the lower cost of manufacturing, and that has been one of the advantages for the exports business. From that perspective, if you want to think about, then how does this investment play out from the profitability point of view?
We looked at setting it up in India as well as Coral Springs. Overall, the lines for both Respimat as well as, actually, Respimat, we're doing a combination of the two. We're doing the cartridge in India, and we're doing the packaging in Coral Springs. For Ellipta, it's a pretty automated line. We really felt the difference was marginal, but there was an advantage of having the manufacturing site close to the R&D site, both for effective scale-up as well as manufacturing. Overall, we felt pretty good about making the investment in the US.
The devices with respect to these products, is this procuring from, let's say, the top three or four global players? Is that how the thought process is going to be?
No, we're actually assembling the devices. So we get the components, and we assemble it.
Interesting. Thanks. Thanks. That's it from me.
Thank you, Tushar. We take the next question from Saion. Saion Mukherjee.
Yeah. Thanks for the follow-up. On the Semaglutide opportunity for next year, how are you thinking? You mentioned about India. How many other markets? How many of them you think you would be in the first wave? If you can talk about capacity and your overall expectation on the market dynamics?
India is the key market from the near-term perspective. Longer-term, we'll obviously play in the developed markets.
South Africa as well.
South Africa is the other market that we have. I think these will be the two key markets. Maybe at some point in time, in the Philippines, but that's it. I think what will really make a difference is largely India and a little bit of South Africa.
From a capacity standpoint, they are in-licensed both for India as well as South Africa.
Okay. Is it possible for you to share the kind of capacities you have in place for next year?
I mean, like we said, they're partnered, but we don't see a capacity concern.
Okay. Okay. My next question would be on the respiratory product in the US. Albuterol has seen erosion. Is it still declining, or has that stabilized? Also, if you can comment on Spiriva, for you, has it stabilized now, or has it come off from the peak? If you have any updated expectation on possible competition, and when that happens, how do you see revenues move in that product?
Albuterol has stabilized, but we see Amnil will likely come in at some point in time. There will be further erosion. On Spiriva, our share has stabilized. At the same time, given this new momentum of the government, U.S. administration trying to focus on biosimilars and generics as a priority for CMS business, which is where we are struggling right now, actually, on Spiriva. We have not been able to get good access on the Medicare front. We are hopeful that we will be able to drive additional share with this new momentum in the quarters ahead. We have not seen any material, we have not heard of any material progress of a competition. We are certainly not hearing from our customers that anyone is close to launching into the Spiriva market anytime soon.
With the Medicare access, when do you see that playing out for you?
Medicare, they have actually prioritized the brand. So it's really trying to see when the government, everything that they're saying right now, that they want to prioritize biosimilars and generics, like a generic-first policy. It's hard to predict when, right? I mean, so we have started to see some gain in share on the Medicare front, but it's still small compared to the opportunity.
Okay. Okay. Thank you.
Thanks, Saion. We'll take the next question from Kunal.
Hi. Thanks for the opportunity again. Just a couple of clarity. Can you give a split for our India business between the prescription business and the adjacency businesses?
Cool. It's almost entirely the prescription business. I think the adjacencies will be less than a couple of percent.
Sure. Yeah. And then secondly, on Mirabegron, Innovator seems to have raised their guidance for the US market by almost 80%. So, is it because of very strong demand in terms of volumes? What kind of dynamics are playing out there?
I think, yeah. The market has grown for Mirabegron, and Innovator has also held on to a good percentage share. I think, if I'm not mistaken, the earlier guidance might have been very conservative.
Sure. Thank you, and all the best.
Thank you.
Thank you, Kunal. Thank you very much to everybody for the patience. I now hand the conference over to the management for the closing comments.
Thank you, friends, for all your questions. We look forward. We've had really strong performance in the last couple of quarters. Look forward to working on continuing this trajectory in the quarters and years ahead. We will look forward to connecting with you next quarter. Thank you, and have a great weekend.
Thank you so much, ma'am. Now, on behalf of Lupin Limited, that concludes this conference. Thank you for joining us. You may exit the webinar. Thank you.