Hi friends, I'm very pleased to welcome you to our quarter one fiscal year 2026 earnings call. I have with me here Nilesh, our Managing Director, and our CFO Ramesh, and of course Ravi online as well. We look forward to sharing with you our highlights for the quarter as well as outlook for the year ahead. We are delighted to begin the fiscal year on a very strong note with continued double-digit growth in both revenues and profitability. Our margins have shown further improvement, rising by 330 basis points year- over- year even as we increased investment in R&D by 150 basis points during the same period. Looking ahead, we are confident that this growth momentum will continue and reaffirm our EBITDA margin outlook for the fiscal year at 24% - 25%. The first quarter marked a significant milestone for our U.S. business.
We successfully launched with sole first-to-file exclusivity, resulting in our highest U.S. revenues since quarter four fiscal year 2017 when we had the Glumetza and the Fortamet franchise. This is despite additional generic competition in albuterol. Our ability to seamlessly launch tolvaptan through specialty distribution channels stands as a testament to the strong execution and commercial capabilities we have built in the U.S. We are confident in our ability to sustain growth in the U.S. market in the mid to long term with a strong pipeline across complex product categories such as injectables, respiratory biosimilars, and 505(b)(2) products targeting brand sales of $150 billion. We expect complex products to really drive a significant portion of our growth and future business. Additionally, we remain focused on expanding our specialty business both organically and inorganically. Coming to India region, we reported growth of 7.8% year- over- year.
Within this, our India formulations business recorded growth of 8.6% during the quarter in line with I PM growth. While key therapies like cardiac, GI, and VMS grew ahead of the market, we have also increased our chronic share from 64% last year to 65% this quarter. Lower on certain in-licensed brands in the diabetes segment have had a negative impact on our growth rates. I'm particularly heartened by our respiratory franchise performance, which grew 18.5% as against the category growth of 12.2% during the quarter. Also, on a MAT basis, the volume growth has been 2.8%, double the volume growth in IPM during this period. During the quarter we successfully completed the transfer of our OTC consumer healthcare business into a 100%- owned subsidiary called Lupin Life Consumer Healthcare.
We believe that this separation will allow the OTC business strategic flexibility to capitalize on the rapidly growing OTC market in India, while enabling the company to sharpen its focus on core strengths in the prescription drugs business. We are confident that our India formulations business will continue to outperform the market, propelled by our extensive portfolio of innovative and unlicensed products as well as the broad reach of our 10,000+ people salesforce. The introduction of new products will be pivotal to our growth, with more than 80 product launches planned over the next five years. As a major player in the cardiac and diabetes segment, GLP-1 products will remain a core part of our India strategy
over the next couple of years.
In addition, we are deepening our presence in GI, aiming to establish this as our fourth major therapy area. We also focused on expanding our presence in oncology and CNS segments. Going ahead, turning to other developed markets, we achieved a 17% year-over-year increase with Europe serving as a key growth driver, recording an impressive 28% increase for the quarter. These markets now account for 13% of our total sales, up from 11% two years ago. Looking ahead, we remain optimistic about sustaining this momentum led by a robust pipeline of complex and specialty products
going ahead.
Our R&D expenses as a percentage of sales stood at 7.9% for the quarter. We are especially encouraged by our recent FDA approvals for generic Victoza and glucagon, which highlight the progress we are making in complex injectables. We take pride in being the first Indian company to secure approval for a GLP-1 product for the U.S. market. Nearly 70% of our R&D investments are directed towards complex and specialty products. We have a robust pipeline with over 60 product filings planned for the U.S. market alone in the coming years. Our position in inhalation is expanding rapidly not just in the U.S. but also across India, Europe, and other international markets. In the complex injectable space, our focus is on developing depo injectables, peptides, iron colloid products, as well as 505(b)(2) s.
We've also established a strong model in biosimilars outside the United States and are well positioned to enter the market in the U.S. On the specialty side, we are advancing a substantial 505(b)(2) pipeline and enhancing our portfolio with value-added medicines such as long-acting injectables, oral solids, IUD implants, and green propellant-based products. These initiatives will require increased investment as we have indicated previously, and we anticipate R&D spend to be between 7.5%- 8.5% level in the fiscal year
2026.
On the compliance front, during the quarter our Nagpur Unit- 2 site received its EIR, while there were some observations in the 483 issued for Pithampur Unit- 2 and Unit- 3 sites. We are confident of addressing the observations effectively and would like to reiterate that we are committed to ensure that all our sites are fully compliant with the FDA and other regulatory agencies around the world. Before I hand it over to Ramesh for a more detailed performance analysis, I want to reiterate our optimism regarding our future growth trajectory. The recent approvals for generic Victoza and glucagon and the expected approval of generic Risperdal Consta mark the beginning of our journey in complex injectable space, which will further strengthen our complex portfolio in the U.S.
Looking ahead to fiscal year 2027, we expect to bolster our momentum with key launches from a biosimilars pipeline in the U.S. as well as our ongoing commitment to build a leading global specialty business leveraging both in-house innovation and strategic acquisitions. We are confident that our focused investments in R&D, patient-centric approach to building specialty brands, and continued efforts in driving efficiencies will drive sustainable growth in the years ahead. With this, I will hand it over to Ramesh.
Thank you Vinita and friends. I welcome you all to our Q1 FY 2026 earnings call. This has been yet another quarter of consecutive double-digit growth across the top line and profits. I'm particularly pleased to highlight our EBITDA margins have expanded by 330 basis points year- on- year to 26.6% during the quarter despite a 151 basis points increase in R&D during this period. Diving into the numbers, sales for Q1 FY 2026 came in at INR 6,164 crores as compared to INR 5,514 crores in Q1 last year, a growth of 11.8% year- on- year. Amongst the key markets, the U.S. grew by 24.3% year- on- year, India region has grown 7.8%, and other developed markets have grown 17.4% during the quarter. Our GRB business grew by 16% year- on- year. The U.S.
business during the quarter recorded sales of $282 million, a growth of 22.3% year- on- year and 12.8% quarter- on- quarter on a constant currency basis. As Vinita mentioned, this quarter was a pivotal one for the U.S. with the successful launch of tolvaptan, its sole exclusivity. This is offset by low generic single-digit price decline in our base products and anticipated impact of new generic competition in albuterol. We're continuing to execute on our strategy to improve our profitability in this segment with yet another quarter of strong profitability from this business. Along the longer term, we remain confident of consistent delivery of profitable growth through an increasing share of complex products in our portfolio. Coming to India, the India region business grew by 7.8% year- on- year during the quarter.
Within this, the prescription business grew by 8.6% year-on-year during Q1 FY 2026 in line with IPM growth. Chronic share during the period was higher at 65% with key segments like cardiovascular, GI, and VMS growing ahead of the IPM growth. The share of in-licensed products is only around 6.2% as compared to around 12% in FY 2025, which also has a positive impact on our profitability going ahead. Insofar as other developed markets are concerned, revenues in our other developed markets were INR 775 crores, representing a growth of 17% year-on-year. This growth was led by a 28% year-on-year increase in Europe. Other emerging markets grew by 5.2% with strong growth in South Africa offsetting tempered performance in LATAM and Philippines.
Coming to various aspects of the P&L, other operating income at INR 105 crores has increased by INR 18 crores as compared to the first quarter. Gross margins, coming to the profitability, gross margins continue the upward trajectory. The Q1 FY 2026 gross margins at 71.3% are up from 68.4% in Q1 last year and up from 69.7% in Q4 FY 2025. This 290 basis points year-on-year improvement is driven by multiple factors, which includes better product mix, tailwinds in the input cost front, lower share of in-licensed products, increased volumes, and other cost improvements and efficiencies which have been undertaken over the last several quarters. Employee benefit expenses at INR 1,083 crores increased 11.5% year-on-year from INR 971 crores in Q1 FY 2025, translating to 17.6% of sales, similar to Q1 last year.
This change is largely attributable to higher costs due to regular annual increments and business growth during this period. Q1 FY 2026 manufacturing other expenses came in at INR 1,772 crores, increasing 10.9% year-on-year from INR 1,598 crores in Q1 FY 2025 and INR 1,688 crores in Q4 FY 2025, translating to 28.7% of sales versus 29% last year. The expenses are mainly high due to higher R&D cost and higher volumes i n the normal closer business. R&D is at INR 484 crores at 7.9% of sales as compared to INR 350 crores, which is 6.3% of sales in Q1 FY 2025 w ith almost 70% of our R&D directed towards complex portfolio. For the full year, as earlier indicated, they expect R&D to be about 8.5%. EBITDA excluding forex and other income, EBITDA was INR 1,641 crores.
We saw this was INR 1,286 crores same period last year, an increase of 27.6% year-on-year with a margin of 26.6% versus 23.4% last year in the same period. On a quarter-on-quarter basis, margins have expanded by 340 basis points. This margin expansion is on the backdrop of higher gross margins and a lower fixed cost during the period. Despite a higher R&D, as previously guided, we expect full year EBITDA margins to be in the range of 24%- 25%. While we expect business to continue to exhibit robust performance, overall margins will be tempered by higher R&D spends and lower PLI in FY 2026 vis-à-vis 2025. Insofar as the ETR is concerned, it was 13.7% for this quarter. However, for the full year, we expect the ETR to be around 19%.
Insofar as the balance sheet is concerned, we're still working on operating working capital, which is of course standing at INR 7,287 crores as of 30 June, against INR 6,821 crores as of 31st March, which translates to 106 days of working capital against 110 days in the previous quarter. Net cash at INR 1,239 crores as against INR 310 crores in 31st March 2025. Whilst we focus on increased cash generation for our business, we'd like to highlight that we continue to explore strategic allocation of our capital to address the long- term vision of the company. On the ESG front, we are pleased to report continued progress in Lupin's environmental, social, and governance performance as demonstrated by our sustainability ESG ratings. This exposure has notably improved from a classification of severe risk in 2019 to a medium risk in 2025.
Additionally, the Lupin Foundation has positively impacted lives of 22,400 individuals by enhancing access to health care and promoting livelihood opportunities. With this, we open the floor for discussions.
Thank you. Thank you very much. We will now begin the question and answer session. Request all 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. The first question is from Kunal Dhamesha. Kunal, you can start please.
Hey, good afternoon. Can you hear me?
Yes, hi.
Thank you for the opportunity and congratulations on a good set of numbers. First question on the top line growth outlook. I think we have provided outlook on R&D EBITDA margin. If you could also provide our expectation for the overall top line as well as U.S. A related question is contribution in Q1, whether it was a partial contribution or a full quarter contribution.
Yeah. Top line growth for the year, as we have guided earlier, we expect strong double- digit both for the company and for the U.S. tolvaptan we launched in late May, so it was a partial quarter. Also, we didn't have, since it's a specialty product, there was not too much of channel stocking ahead of the launch.
Sure, that's helpful. The second one on the India business, the overall India business growth seems to be lower than our formulations business. Has the adjacency, which is a small part of the business, kind of impacted or was there a tender business last year that has impacted the growth? How should we think about it?
Yeah, it's primarily the tender business. It's the institution business which is impacted, and as we've discussed before, that's lumpy. By and large, I think we're in a good place on the global institution business as well.
Okay, sure. One more if I may. What would be the current drag from the adjacency business like diagnostics etc. in this quarter particularly?
Yeah, so the impact on our EBITDA would be close to about 1%. They are still evolving and coming up very nicely. The long- term obviously looks very alluring to us. Clearly there's loss making at this stage.
Sure. Thank you and all the best.
Thank you, Kunal. This next question is from Vivek from Citi. Vivek
you are
Yeah, hi. Thanks. Thanks for the opportunity. Can you help us understand how to look at the U.S. sales in FY 2027, right? In 2026, it is going to be good because you launched upon, etc . In 2027, there may be a cliff as products like tolvaptan, mirabegron, et c, may not be as big as they are in 2026. How should we look at the overall sales in 2027, especially for the U.S., and what are the specific products, if you would like to highlight, that can help you mitigate the impact of decline in these products? Thank you.
Sure. There are many moving parts right now. I mean on also material products like tolvaptan as well as mirabegron. Right now there are no other tentative approvals on tolvaptan and it's a specialty product that requires named patient REMS program. We expect substitution to be very different compared to simple oral solid generic. That's number one. Two, with mirabegron there are, depending on the outcome of litigation, as well as the trial of some of our competitors later this year, there
multiple scenarios that can emerge.
We should have better clarity about that more at the end of this fiscal year. Certainly in the second half of the fiscal year, we should have better clarity on the competition for products like mirabegron. Third, I would say that we have a number of new growth drivers. We are very excited with the buildup of our injectable pipeline portfolio with approvals of significant products like glucagon and liraglutide. We have a goal date for Risperdal Consta in September. Hopefully the quarter after that we launch Risperdal Consta. The injectables start becoming a growth driver for us at the second half of this fiscal year, building into fiscal year 2027.
Fourth, I would say that biosimilars are starting to look pretty promising as an opportunity just given where things are in terms of access to market in the U.S. and from our perspective, we have pegfilgrastim that we will hope to receive approval for this year. We are making good progress on the OBI pegfilgrastim. We would expect that hopefully to be filed and also get approved in fiscal year 2027 or 2028. In fiscal year 2027, we also expect in June 2026 we have the goal date for ranibizumab that we filed a few months ago. We expect both OBI as well as ranibizumab to potentially come to market in fiscal year 2027, building into fiscal year 2028 as well. While some of the exclusive products we will have additional competition impact, we think that some of the products are more sticky than others.
We remain very optimistic about growth prospects certainly for the company overall. We expect a very high single-digit growth for the next fiscal year, and hopefully double- digit as well based on the efforts our team has undertaken.
I'll just add perhaps there might be some volatility amongst quarters and the like, but one is playing for the long- term and clearly you see secular growth over a period of time, over an extended period of time given a focus on a number of differentiated products, 505(b)(2) s and the like.
In FY 2027 you are aspiring to be like a high single-digit plus growth on 2026, right? If I'm correct.
As a whole for the company.
Yeah. Just one clarity on pegfilgrastim On-Body Injector. Have you filed or yet to file this product? Which product are you expecting first, the normal pegfilgrastim or the OBI one?
I'm interested primarily in the OBI, although the pegfilgrastim approval will come sooner. We hope to file this during this fiscal year.
Okay, just one more question I have on cost front, right. Last year the company saved close to around $50 million. It would be great actually if you can highlight what are the targets for the next couple of years, especially in the area segments where the company is working on as far as improvement in the cost structure. I'm just trying to understand again margins for 2027, right? 2027 is, you have guided 24%, 25%. Is it possible if the margins in 2027 can dip on 2027 on the base of 2026 or you can still maintain margins in 2027 on the base of 2026. Thank you.
You know, the fact is we are playing for continuous margin expansion, and this is on the back of, in fact, buoyancy on the top line. We did indicate that next year also we would grow at least single-digit numbers. The focus on various items of cost is insistent, and you appreciate it's there, the evidence is there to see, and that will kind of provide for margin expansion going forward as well, despite, in fact, the kind of increases that we are seeing on the R&D front. We are pretty optimistic about this.
Thanks. That's from my side.
Thank you, Vivek. The next question is from Saion Mukherjee of Nomura.
Thanks for taking my question, Vinita. One question is on this whole tariff scenario. We may see an announcement in the near- term. How are you assessing that? Any color you can provide given the kind of products that you have or other mitigating measures that can be put in place? Basically, broadly trying to understand how you see the impact, let's say if you have 10% or 15% kind of tariff being put on generic pharmaceuticals.
Saion, it's of course hard to predict where this lands based on the outcome of the 232 investigation. I'd say that from a mitigating standpoint, the strategies that we have considered are, one, wherever we can, where we have price flexibility, price increase to offset the impact of tariffs. Number two, products where we have the ability to tech transfer into the U.S., certainly in the two sites, both New Jersey as well as Coral Springs, we're looking at a potential to transfer those products. We are also considering some IP transfers that will have a capital gains impact, but overall will really benefit us, especially on high value products where we transfer the IP to the U.S. and contract manufacture in India. A combination of all of those measures, we expect to be able to mitigate a good percentage of the impact of tariffs.
If it's 10%, 15%, I think it should be fairly manageable. In any case, the question is, is it 25% or the 150% - 200% kind of numbers that have been floated.
At the end of the day, generics is all about access to medicines insofar as the population is concerned. They would also be very conscious of whatever measures that they take, so it doesn't impact them too much, you know, considering the availability of products and the like in recent times.
Okay, that's helpful. The second question is on specialty. You're thinking about it for a while now. Given the changes that we are seeing in the U.S., particularly with respect to the pricing environment, is that changing your thought process around how you should be thinking about going about building the specialty business globally and in the U.S. in particular.
Strategically, our focus has really been in niche therapy areas where we can really add value. Areas like
respiratory and again niche
respiratory products or products that, you know, are not large as my COPD products where we compete with big pharma, plus, you know, like rare neurology products like neuromuscular. We're actively developing neuromuscular for the U.S as well as other geographies, Europe included. You know, we expect that the impact of MFN, you know, and all of the price reduction measures is likely going to have more of an implication for the large value categories, where there is material spend from a government standpoint and a payer standpoint.
Given our strategy is more on
niche products, we believe that we will be in a better position than large brand companies in any case.
Understood. If I can ask you, [Ms.] Vinita, on NaMuscla if you can update us on the timeline for the U.S. and the market opportunity. Thank you.
We are in active recruitment right now for our phase three study for the U.S. and Europe. We expect that the product will launch in the U.S. in fiscal year 2029, and we believe that there's a market
opportunity of between $100 million- $200 million.
Okay, thank you. I'll join back. Thanks.
Thank you. Saion. The next question is from Kunal Randeria of Axis.
Hi, good afternoon. Any update on semaglutide filing plans in Canada?
No, I think from a near- term perspective for the markets that open, we really have a partnered model. We have a partnership in place that will get us into the market, but internal injectable filing is a little bit later due to the hurdle patent in the U.S. and other major markets.
Sorry, I meant Canada, semaglutide in Canada.
That will come through partnered like Vinita said.
Okay, got it. Just to clarify, on mirabegron patent litigation, there are, I think, two patents under active litigation, right? In one of the patents, I think the outcome depends on what one of the other competitors, you know, how their litigation goes. Is there a likelihood of this drug facing competition by November itself?
It's hard to predict.
I would say it really would be hard to predict. Anybody who's going through litigation in the fall this year also has potentially looking at the timeline of a February trial, which is going to be material for the product.
Right, got it.
Thank you.
Thank you. Kunal. The next question is from Damayanti of HSBC.
Hi, thank you for the opportunity. I hope I'm audible.
Yes.
Okay, my question is on your injectable portfolio buildup. First, have you launched glucagon and lira in the U.S., and are these products completely in house or are you engaging with some partners as well?
We have launched glucagon yesterday and plan to launch liraglutide by October, and we manufacture the products in-house in Nagpur.
Okay, why are we waiting till, you know, next few months for lira launch?
That's the time it takes to really do the validation and get launch quantities together.
Okay.
How do you see liraglutide market in the U.S., given the market in general has moved to the new gen therapies, right, your sema and tirzepatide, etc.? Do you think this market is still attractive?
We believe it's attractive because it's $500 million+ and the very limited number of players right now. As the product gets more affordable with additional competition, we would expect that there is some share that the product should take from the overall class, definitely the portion that is price sensitive.
Sure. From a sales buildup perspective, we should assume by FY 2027 that these two products are coming in FY 2026 and hopefully respiratory constraint also comes through. You have three key products in your portfolio to start with, and then assuming it will take a few months to build out, etc., so FY 2027 onwards we can assume these to be significant contributor in the U.S.?
That's right.
Okay, my next question is on your EBITDA margin. Ramesh, you mentioned there was some 1% drag due to adjacency in India. Similarly, can you quantify if there are other such drag on margins which are right now due to some, you know, investment or scale up, which are underway and then you expect these things to go away in a few years, a few quarters.
What I actually meant was that the adjacent fees are costing us some monies because essentially they are still evolving, essentially the digital business, the diagnostics business, the API CDMO business and the like. Clearly, you know, because there is, you know, time for them to evolve. They're all start-ups, so to speak. Clearly they would evolve to a size, to critical mass and they would start making profits. Until then, for example, the diagnostics business is expected to kind of break even next year. That pathway has been very well set.
Okay, my next question is on your inhalers portfolio. On tiotropium, have you seen any meaningful market share than what we saw last quarter?
It has been at a similar level.
What is actually stopping you to gain more market share or you have already reached the upper limit and then we might not see market share gain from here. What are your thoughts on tiotropium market share gain?
The team has additional efforts around offsetting some of the costs to patients, especially in the Medicare Medicaid- covered patients. That's where we don't have a strong share. I mean we have a really good share of the commercial covered patients, 50%+ . The Medicare Medicaid is where we are starting to see some benefits, but it's not showing in the numbers as of yet. We hope that in the next couple of quarters that builds up.
Okay, so going ahead, we might see more market share gain on the Medicare channel, but on the commercial channel you are broadly maybe at optimum level. Is that the way to look at this?
Yes
Okay. Okay, that's helpful. Thank you.
Thank you.
Thank you Damayanti. The next question is from Neha Manpuria from Bank of America .
Thanks so much, Ravi. My first question is on tolvaptan. Vinita, I think you'd mentioned that based on contracts that we have in place, you know, we should be able to get to about 25% market share until wept in. Is that still the case or have you seen additional traction on the specialty contracts? You know that the market share could be higher.
It is hard to predict. Right now we've got good ramp up within the specialty channel, but it's still building. The conversion is still taking place. I think that what you see is the impact of a couple of months of starting to build the share. We should be able to see more of an impact in Q2 and Q3.
The full contracted share will probably reflect exit of second quarter or third quarter. Would that be a fair assumption?
Yes.
Okay. Given that there is no tentative approval for tolvaptan, is it fair to assume that, you know, we could probably have a longer tail for tolvaptan versus let's say a usual FTF product?
We're hoping, you know, if we had estimated that we'll have additional competition in six months. If we don't see it or if it's limited, one instead of two, perhaps there's more of an upside. In any case, even with additional competition, we expected a longer tail. Given that it's a specialty product, the specialty channels and the physicians don't like to change patients over and over again to a new product.
Okay, understood. My second question, glucagon, while your press release mentions just the generic market, I mean the, you know, IQVIA market for the generic and the brand, there are also 505(b)(2) in glucagon. Would it be fair to assume that our generic would be able to probably even look at that part of the market, the 505(b)(2), or do you think it's just restricted to the generic products and the brand?
Yeah, we're targeting the entire market, but we'll know in the next couple of months how much of a share you can take up the whole market.
Understood.
Okay.
Thank you so much.
Thank you.
Thank you, Neha. The next question is from Shyam Srinivasan of Goldman Sachs.
Good evening. Thank you for taking my question. I think in the opening remarks, you talked about potential new generic entrants on albuterol, right? Is there something that we need to worry about? Also, from your competitive study or market study, how far away are other generics? One, say, Spiriva perhaps?
Yeah. Amphastar has entered the market, you know, on albuterol, and we've seen some impact of that that you also see in the quarter that we anticipated on Spiriva. I mean, you have multiple, couple of companies that have filed, but just given the time it takes and the source of supply of these companies, it's hard to say, you know, companies like Alvogen and Teva if they're going to get to the finish line on a timely basis. We hope it takes them as long as it took us five years to get approval.
Safe to assume another at least 12 to 18 months of runway for us?
I would think so.
Okay, that's very helpful. Just a second question. On biosimilars, since you have been starting to be more vocal, you've done an agreement on Zentiva, so it's a late entrant, especially in the U.S., not necessarily Europe, but U.S. Do you see economics still reasonable, something that you will allocate additional capital to? Opening remarks, again, you talked about on-body versus just the regular one. Is there some different entry strategy we might be doing as a follower, second wave? How do we prepare for the 2029 kind of wave of the next biosimilars?
Yeah. I think while we are a late entrant, just given the market evolution, we may not be a late entrant. You're just seeing substantial kind of easing on market access in the last 6 to 12 months, right? With HUMIRA and the private labels that have come into market, like the Cordavis label, the Quallent label, they certainly have demonstrated the impact that some of the major customers can have with the private label strategy into the marketplace. I'd say that from a capital allocation standpoint, we haven't shifted gears as of yet because we have a handful of products that are available to us already. We have, of course, pegfilgrastim, we have Onpro, and we have interest both from partners as well as with a few of the oncology products that we have in a generic pipeline.
Our commercial team is also looking at how we can leverage that to come to market direct. Plus, on the ophthalmic front, given our ophthalmic portfolio, products like ranibizumab, aflibercept that come to market potentially in 2027 and 2028 can be good drivers of growth for biosimilars for us, just given the limited number of competitors. In 2029, we expect etanercept, we're going to be likely one of four. That's still a material product, despite the price erosion that it has seen after IRA or will see based on the IRA negotiation, still a significant product that we expect to benefit from. We have a pipeline that we are pursuing. There's certolizumab that we are developing. We are going to start development, clinical development of certolizumab soon. We have respiratory biosimilars, mepolizumab and benralizumab that help us serve multiple markets, multiple geographies, not only the U.S.
but also Europe, where we have a considerable position now with Luprobec. In India, biosimilars are gaining momentum in our portfolio, especially of oncology and immuno-oncology products like pembrolizumab and nivolumab that we are developing for India. Biosimilars is emerging as a platform that is going to have relevance for us in the U.S., other developed markets like Europe, Canada, Australia as well as India. A global platform that is really promising and we will see as we, you know, we think that with the easing of the regulatory requirements from a clinical standpoint as well as market access, it certainly will lead other companies also to accelerate their plans on the biosimilars front. We'll have to be mindful of portfolio choices that we make because again, it will be like complex generics.
We want to participate in products where we have the first wave and we have barriers to entry, where we have exclusivity or semi-exclusivity is what we are targeting, or we have a market position that we can leverage like ophthalmics or respiratory.
Great, thank you. Thank you and all the best.
Thank you.
Thank you. Shyam. Just a reminder to all participants who would like to ask questions, please raise your hands from the participant tab for more questions. In the meantime, we'll take the next question from Shashank Krishnak umar of Emkay.
Thanks for taking my question. My first one was on DULERA. Are we still on track for an FY 2027 launch in this product?
Yes. I'll be expecting to respond to the CRL in fiscal year 2026, this fiscal year, and hopefully by the second half of fiscal year 2027 or early 2028, we should be in the market with DULERA.
All right, thanks. Second question was on the India business. I think in-licensing share obviously has come down to mid single-digits now. How do you sort of look at this going forward? Are we going to double down on our core business or will in-licensing still remain a key part of our domestic growth strategy in the medium- term? Just wanted to get your thoughts.
Sure.
I think the focus on licensing remained all this while, but obviously with the LOEs and competition that share has just been coming down. It's now down to 6% from a high of, I think, more than 20% at one point of time. The focus remains, I think, for example, even on GLP-1s, on other products there is intent to in-license. There's a rich funnel. The focus in the last three years, I would say, has been moving to focus on our own portfolio, including building our own novel portfolio as well. We're making good progress on that. I think that will remain the primary focus. Obviously, for the right kind of products, we would still want to in-license.
Thanks, that's helpful. If I could just squeeze in one more. Vinita, I think you mentioned about phase III trials in the U.S. for NaMuscla, but I think there has been slight debate in phase III. Is it largely a function of patient recruitment, or has there been any other challenges?
No, it has been patient recruitment that has been slow. We are looking to actually open up some new centers as well.
Got it. Thank you, that's helpful. All the best.
Thank you.
Thank you. Shashank. The next question is from Tushar Manudhane of Motilal .
Thanks for the opportunity. Am I audible?
Yeah.
Could you speak up a little bit? We can't hear you clearly.
Is this better?
Yeah.
Just on liraglutide, while you know there is authorized generic as well as a couple of more approvals already, you know how to think about this opportunity for Lupin?
For us strategically, I mean, you know, one of our first few injectables, first product out of India. It starts creating a reputation for Lupin on the injectable front and still a sizable product with a third entrant into the market potentially in October. We look at it as a sizable opportunity. Also, add to that with Saxenda potentially coming to market in the following year because it's a very similar product to Victoza and Saxenda.
Ma'am, with respect to respiratory Risperdal Consta, the goal date being September 25. Is this to do with certain queries to be addressed, and which is where the timeline is? September 25. If you can just elaborate on that aspect.
Yes, we had a couple of information requests based on which the goal date was moved to September. We are responding to them, we had responded to them effectively. We believe we are on track for September.
Okay.. This would be like, this is a broad idea in terms of, you know, how many times or how many queries typically U.S. FDA would sort of view for such complex product before getting the final document.
You know, it's hard to predict. I remember we had looked at tiotropium. We had, at the end, 18 queries, you know. We are hoping that we are at the tail end with Risperdal Consta.
Just lastly on tolvaptan, in the past there have been certain tentative approvals. Is it not going to be competitive post 180-day exclusivity?
We haven't seen any tentatives so far.
Okay, thanks. That's it from us.
Thank you, Tushar. Follow-up question from Kunal Dhamesha of Macquarie.
Thank you for the opportunity. Again, just a few clarifications on the pricing comment. Ramesh, you said that it's a low single-digit. There it is. Excluding albuterol impact or including albuterol impact?
Including. Including albuterol.
Okay, that's great. Secondly, on tolvaptan, is it our own REMS or is it a shared REMS with the innovator?
You know we don't want to share that. It's confidential.
Sure. Thirdly, in terms of sema Canada, has your partner's filing been accepted by the Canadian authority?
No, still in the works. It hasn't been filed as of yet.
Sure. The last one on DULERA CRL, what is the nature? Is it to do with some clinical data or CMC queries or how should we think about that?
We wouldn't want to talk about that.
Okay, sure. Thank you.
Thank you, Kunal. Just a request, a reminder to participants, if you have any questions, please raise your hands in the participants tab. In the meantime, we'll take a question, a follow-up question from Saion of Nomura.
Thanks, Ravi. Thanks for taking the follow-up. Just, you know, few product specific questions. You had mentioned about a product called dalbavancin some time back. Is this expected for launch this year?
Yes.
Okay. The other question is on GLP-1, you know, if I heard you correctly, you said Victoza generic in September, is that right? For the U.S. is what I talked about.
Yeah. liraglutide to Victoza. Yeah. Approval in September, launch in October, likely.
Okay.
Sorry, launch in October.
September was really Risperdal Consta . That's what I was talking about.
Okay. Okay.
Victoza, like next year is what you're expecting?
No, Victoza has just got approved.
Sorry, Saxenda, next year. Sorry.
Yeah, it's confusing.
Saxenda, you're expecting. Just to clarify, Saxenda, you're expecting this year approval, FY 2026?
We are hoping that we get approved sooner rather than later. I mean, the goal date is into next year. Now that we've got the Victoza product approval, we hope that the FDA is going to expedite.
Okay. Given that, you know, you're one of the few companies which have been able to get an approval for a GLP-1 product, just from a regulatory standpoint, maybe for the U.S. of course, and for other markets, how do you see the hurdle from a regulatory approval perspective? Is there any takeaway for semaglutide or these are completely different products? Also, on sema, Nilesh, if you can share your thoughts on India and the other markets and how excited you are about the opportunity next year.
Yeah, I think that it's fair to say the radio type was a complex product. Approval through the FDA. The team really worked hard to respond to a number of pretty tricky queries, and we believe that, you know, not everyone will get to the finish line. We think that the competitive dynamics there might be a little bit different than we had earlier expected.
I think what it does also is gives us a lot more capability. Our people are a lot more confident to be able to develop other products in the GLP-1 space on semaglutide India. The injectable, we hope to be in the first wave. That will come through partnership, and the oral solid is what we are developing internally. That will come a little later, hopefully in the next fiscal year.
Okay, you mean fiscal 2027.
Yeah, FY 2027 for the oral, end of FY 2026 for the injectable. You know, we're a large metabolic player. Obviously from that perspective, this is very interesting. There will be competition, but I think we should be able to get more than our more than typical share.
Do you see the risk of delay launch from a regulatory standpoint in India for the injectable?
Nobody's bought it yet, right? Everybody knows it's under development across the board. I think there could be, but I think better than even chances of it coming through at that time.
Understood. Okay. Thanks. Thanks a lot.
A final reminder to all participants who want to ask questions, please raise your hand in the participants tab.
Since there
there are no further questions and I would hand the conference over to the management for closing comments.
Thank you Ravi.
I hope we were able to respond to all your questions. You know, I know a number of questions on our portfolio and portfolio evolution as well as growth prospects. I just want to reiterate that we are very optimistic that we continue our growth momentum this fiscal year as well as in the next couple of years, despite the challenges on additional competition on key products. We believe that we have significant drivers, growth drivers in place, and the team is very excited and energized to build on the success that we have built over the last couple of years and into this fiscal year as well. I look forward to continuing the momentum and connecting with you again over the next couple of quarters. Thank you.
Thank you very much. On behalf of Lupin Limited, this concludes our conference. Thank you for joining us. You may now exit the webinar.