Lupin Ltd (NSE: LUPIN) Q1 2026 Earnings Call dated Aug. 06, 2025
Corporate Participants:
Unidentified Speaker
Vinita Gupta — Chief Executive Officer
Ranesh Swaminathan — Executive Director, Global CFO, Head of IT and API Plus SBU
Analysts:
Unidentified Participant
Vivek — Analyst
Saion Mukherjee — Analyst
Kunal Randeria — Analyst
Damayanti Kerai — Analyst
Shyam Srinivasan — Analyst
Shashank Krishnakumar — Analyst
Tushar Manudhane — Analyst
Presentation:
operator
Is being recorded. I now hand over the conference over to the management. Thank you. And over to you.
Vinita Gupta — Chief Executive Officer
Thank you. Ravi hi friends. I’m very pleased to welcome you to our quarter one fiscal year 26 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 and 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 to 25%. The first quarter marked a significant milestone for our US business. We successfully launched Tolvaptan with sole first to file exclusivity resulting in our highest US revenues since quarter four fiscal year 2017 when we had the Glumetza and the Fortimet franchise. And this is despite additional genetic competition in Albuterol. Our ability to seamlessly launch Tolvaptin through specialty distribution channels stands as a testament to the strong execution and commercial capabilities we have built in the US we are confident in our ability to sustain growth in the US market in the mid to long term with a strong pipeline across complex product categories such as injectables, respiratory biosimilars and 505 B2 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 India formulations business recorded growth of 8.6% during the quarter in line with IBM growth while key therapies like cardiac, GI and VMS grew ahead of the market and we have also increased our chronic share from 64% last year to 65% this quarter. Loe 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 an MAT basis the volume growth has been 2.8% despite doubled 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 plus 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, GLP1 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 to 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 and 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 GLP1 product for the US market. Nearly 70% of our R and D investments are directed towards complex and specialty products. We have a robust pipeline with over 60 product filings planned for the US market alone in the coming years. Our position in inhalation is expanding rapidly not just in the US but also across India, Europe and other international markets.
In the complex injectable space, our focus is on developing depo injectants, peptides, iron colloid products as well as 505 B2s. 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 B2 pipeline and enhancing a 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 and D spend to be between 7.5 to 8.5% level in fiscal year 26.
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 risperdalconsta marked the beginning of our journey in complex injectable space which will further strengthen our complex portfolio in the US.
Looking ahead to fiscal year 27 we expect to bolster our momentum with key launches from a biosimilars pipeline in the US as well 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 and 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.
Ranesh Swaminathan — Executive Director, Global CFO, Head of IT and API Plus SBU
Thank you Vinita and friends. I welcome you all to our Q1 FY26 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 151 basis points increase in R and D during this period. Diving into the numbers, sales for Q1FY26 came in at 6164 crores as compared to 5514 crores in Q1 last year. A growth of 11.8% year on year. Amongst the key markets the US 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 GRP business grew by 16% year on year. The US business during the quarter the US business 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 US with the successful launch of Tulvaktan with sole exclusivity. This is offset by low generic single digit price decline in our base products and anticipated impact of new generic competition on al. We continue to execute on a strategy to improve our profitability in this segment with yet another quarter of strong profitability business from this business on 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 to during Q1 FY26 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 FY25 which also has a positive impact on our profitability going ahead. And so far as developed other developed markets are concerned, so revenues in our other developed markets were 775 crores representing a growth of 17% year on year.
This growth was dealt by 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 PL, other operating income at 105 crores has increased by 18 crores as compared to the first quarter. 25 gross margins coming to the profitability gross margins continue the upward trajectory. The Q1 FY26 gross margins at 71.3% up from 68.4% in Q1 last year, not from 69.7% in Q4 FY25. 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 undertaken over the last several quarters.
Employee benefit expenses at 1,083 crores increased 11.5% year on year from 971 crores in FY in Q1 FY25 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. Q1FY26 manufacturing other expenses came in at 1772 crores increasing 10.9% year on year from 1,598 crores in Q1FY25 and 1688 crores in Q4FY25 translating to 28.7% in sales versus 29% last year. The expenses are mainly high due to higher R and D cost and higher volumes. In the normal course of business R and D is at 484 crores at 7.9% of sales as compared to 350 crores which is 6.3% of sales in Q1FY25 with almost 70% of our R and D directed towards complex portfolio for the full year.
As earlier indicated they expect R and D to be about 8.5% EBITDA extruding forex and other income. EBITDA was 1,641 crores, Visa was 128.6crores last 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 RD as previously guided we expect full year EBITDA margins to be in the range of 24 to 25 basis points 24 to 25%.
Whilst we expect business to continue to exhibit robust performance, overall margins will be tempered by higher RD spends and lower PLI in FY26B service 25 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 7,287 crores as 30 June. Again 6,821 crores as of 31st March which translates to 106 days of working capital against 11010 days in the in the previous quarter net cash at 1,239 crores is against 31010 crores in 31 March 25th.
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 to the Lupin foundation, we have possibly impacted the lives of 22,400 individuals by enhancing access to healthcare and promoting livelihood opportunities.
With this, we open the floor for discussions.
Questions and Answers:
operator
Yeah. 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. So the first question is from Kunal. Kunal. Dhamisha. Kunal, you can, you can start please.
Unidentified Participant
Hi, good afternoon, can you hear me?
operator
Yes.
Unidentified Participant
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 and D bita margin. But if you could also provide our expectation for the overall top line and as well as us. And then a related question is ton contribution in Q1, whether it was a partial contribution or a full quarter contribution.
Vinita Gupta
Yeah. So top line growth for the year as we have guided earlier, we expect strong double digit both for the company and for the US And Vapton we launched in late May, so it was 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.
Unidentified Participant
Sure, sure, that’s helpful. And second one on the India business. The overall India business growth seems to be lower than our formulation business. So has the adjacency which is a small part of the. Has that kind of impacted or there was a tender business last year that has impacted the growth. How should we think about it?
Ranesh Swaminathan
Yeah, it’s primarily the tender business. It’s the institution business which is impacted and as we’ve discussed before that’s lumpy. But by and large I think we’re in a good place on the global institution business as well.
Unidentified Participant
Okay, sure. And one more if I may. What would be the current drag from the adjacency business like diagnostics etc. In this quarter particularly?
Ranesh Swaminathan
Yeah, so the impact on our EBITDA would be close to about 1%. Really? They are still evolving and you know, coming up very nicely. So the long term obviously looks very alluring to us. But clearly you know, there’s loss making at this stage.
Unidentified Participant
Sure. Thank you and all the best.
operator
Thank you. Kunal. This next question is from Vivek from City Vic. You are.
Vivek
Yeah, hi. Thanks. Thanks for the opportunity. So can you help us understand how to look the US sales in FY27. Right. In 26 it is good, it is going to be good because you launched to lockdown etc. But in 27 there may be a cliff as products like ton, mirabeground etc that may not be as big as they are in 26. So how to look the overall sales in 27 especially for the US 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.
Vinita Gupta
Sure. So there are many moving parts right now. I mean on also material products like Tool Vaptin as well as Metabagron. You know right now there are no other tentative approvals on Tulvectin and it’s a specialty product that requires named patient REMS program. So we expect substitution to be very different compared to simple oral solid genetic. That’s number one. Two with mirabegron there are, you know, depending on the outcome or litigation, as well as the trial of some of our competitors later this year, there are multiple scenarios that can emerge. So 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 Rispedale Consta in September. So hopefully the quarter after that we launch Respedal Consta. So the injectables start becoming a growth driver for us at the second half of this fiscal year building into fiscal year 27. And fourth, I would say that Biosimilar is starting to look pretty promising as an opportunity just given where things are in terms of access to market in the U.S.
from our perspective, we have Pegfeld Grastem that we will hope to receive approval for this year. We are making good progress on the OBI PEG for Grastam. So we would expect that hopefully to be filed and you know, also get approved in fiscal year 27 or 28 and fiscal year 27 we also expect in June 26th we have the goal date for Ranibizumab that we filed a few months ago. So we expect both OBI as well as Ranibizumab to potentially come to market in fiscal year 27, building into fiscal year 28 as well. So, you know, while some of the exclusive products we will have additional competition impact.
We think that some of the products are more sticky than others. And you know we remain very optimistic about growth prospects certainly for the company overall. You know we expect a very, you know, high single digit growth for the next fiscal year, you know, and hopefully double digit as well based on the efforts our team has undertaken.
Ranesh Swaminathan
And I’ll just add, you know, perhaps there might be some volatility amongst quarters in the like but one is playing for the long term and clearly we see secular growth over a period of time, over an extended period of time given a focus on a number of differentiated products 550 and the like.
Vivek
So basically in FY27 you are aspiring to be like a high single digit plus growth on 26, right. If I’m correct as a whole for the company. Yeah. And just one clarity on PEG fill Grass team on Body Injector. So have you filed or yet to file this product? Which product that you are expecting first? Right. The normal pegfill GAS team or the OBI one?
Ranesh Swaminathan
I’m interested primarily in the obi, although the PEG for grasp approval will come sooner. We hope to file this during this fiscal year.
Vivek
Okay, just one more question I have on cost front, right. Last year the company saved close to around $50 million. So it would be great actually if you can highlight what are the targets for the next couple of years especially in the area segment where the company is working on as far as improvement in the cost structure. Actually I’m just trying to understand again margins for the 27. Right. 27 is you have guided 24 to 25% but is it possible if the margins in 27 can dip on 27 on the base of 26 or you can still maintain margins in 27 on the base of 26.
Thank you.
Ranesh Swaminathan
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. And we did indicate that next year also we would grow up at least single digit numbers. But the focus on various items of cost is, is incessant and you depreciate, you know it’s there to, for 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 and D front. So we’re pretty optimistic about this.
Vivek
Thanks. That’s from my side.
operator
Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Mukherjee of Nomura. Thank you Vivek. The next question is from Mukherjee of Nomura.
Saion Mukherjee
Thanks for taking my question, Vinita. I mean one question is on this whole tariff scenario, you know, 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.
Vinita Gupta
So Zion, it’s of course hard to predict, but where this lands based on the outcome of the 232 investigation. But I’d say that from a mitigating standpoint, the strategies that we have considered is one, wherever we can, where we have price flexibility, you know, price increase to offset the impact of tariff number two, you know, products where we have the ability to tech transfer into the U.S. you know, certainly in the two sites, both new Jersey as well as Coral Springs, we are looking at a potential to transfer those products. And we’re also considering some IP transfers that of course will have a capital gains impact, but overall will really benefit us, especially on high value products where, you know, transfer the IP to the US and contract manufacture in India.
So combination of all of those measures, we expect to be able to mitigate good percentage of the impact of tariffs. And if it’s 10, 15%, I think it should be fairly manageable. In any case, the question is, is it 25 or percent or the 150 to 200% kind of numbers that have been floated. And you should also remember at the end of the day, genderx is all about access to medicines insofar as the population is concerned. So 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.
Saion Mukherjee
Okay, okay, that’s helpful. And the second question, you know, is on specialty, you know, you’re thinking about it for a while now given the changes that we are seeing in the US 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 US in particular.
Vinita Gupta
So you know, strategically our focus has really been in niche therapy areas where we can really add value. So areas like respiratory and again niche respiratory products or products that are not large asthma COPD products where we compete with big pharma plus rare neurology products like Nemuscular. We’re actively developing Nemuscula for the US as well as other geographies, Europe included. We expect that the impact of MFN and all of the Price reduction measures is likely going to have more of an implication for the large value categories. You know, where there is material spend from a government standpoint and a payer standpoint.
And 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.
Saion Mukherjee
Understood. If I can ask you SM on Nescula, if you can update us on the timeline for the US and the market opportunity. Thank you.
Vinita Gupta
Yeah. So from. So we’re in active recruitment right now for our phase three study for US and Europe. We expect that the product will launch in the US in fiscal year 29 and we believe that there’s a market opportunity of between 100, $200 million.
Saion Mukherjee
Okay, thank you. I’ll join back. Thanks.
operator
Thank you. Saiyan. The next question is from Kunal Randari of Access.
Kunal Randeria
Hi, good afternoon. Any update on semaglutide filing plans in Canada?
Ranesh Swaminathan
No.
Vinita Gupta
I think, you know, from a near term perspective for the markets that open, we really have a partnered model. So we, we have a partnership in place that will get us into the market. But internal injectable filing is a little bit later, you know, due to the, the hurdle pattern in the US and other major markets.
Kunal Randeria
Sorry, I meant Canada. Semaglutide in Canada.
Ranesh Swaminathan
So that will come through partnered like Vinita said.
Kunal Randeria
Okay, got it. Just to clarify, on Mera background patent litigation, there are I think two patents under active litigation. Right. And in one of the patents, I think the outcome depends on what your one of the other competitor, you know, how their litigation goes. So is there a likelihood of this drug facing competition by November itself?
Vinita Gupta
Well, so it’s hard to predict I would say, you know, it really would be hard to predict. And anybody who’s going through litigation in, you know, the fall this year also has potentially looking at the timeline of our February trial which is going to be material for the product.
Kunal Randeria
Right, Got it. Thank you.
Vinita Gupta
Yeah.
operator
Thank you. Kunal. The next question is from Damianti of hsbc.
Damayanti Kerai
Hi. Thank you for the opportunity. I hope I’m audible.
Vinita Gupta
Yes.
Damayanti Kerai
Okay, so my question is on your injectable portfolio buildup. So first, have you launched Glucagon and Lira in the US and are these products completely in house or you are engaging with some partners as well?
Vinita Gupta
So we have launched Glucagon yesterday and. Plan to launch Liraglutide by October and we manufacture the products in house in Nagpur.
Damayanti Kerai
Okay, so why like we are waiting till, you know, next few months for lira launch?
Vinita Gupta
That’s the time it takes to really do the validation and get launch quantities together.
Damayanti Kerai
Okay, and how do you see liraclutide market in the US Given the market in general has moved to the new gen therapies. Right. Your SEMA and dog appetite etc. So do you think this market is still attractive? We believe it’s attractive because it’s half a billion dollars plus and they’re very limited number of players right now. And 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. You know, definitely the portion that is price sensitive.
Vinita Gupta
Sure. So from sales buildup perspective we should assume by FY27, say like these two products are coming in FY26 and hopefully respiratory constraint also comes through. So 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 FY27 onwards we can assume these to be significant contributor in the U.S. that’s right.
Damayanti Kerai
Okay, my next question is on your EBITDA margin. So Ramesh, you mentioned There was some 1% drag due to adjacency in India. So 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, you expect these things to go away in few, a few years or few quarters.
Ranesh Swaminathan
So what I actually meant was that the adjacenties are costing us some, some monies because essentially they are still evolving, essentially the digital business, the diagnostics business, the API CDMO business and the like. So clearly, you know, because there is, you know, time for them to evolve. They’re all startups, so to speak. Clearly they would evolve to a size, to critical mass and they would start making profits. So until then, you know, but for example, the, the diagnostics business is expected to kind of break even next year. So that pathway has been very well set.
Damayanti Kerai
Okay, my next question is on your inhalers portfolio. So on Diotropium, have you seen any meaningful market share than what we saw last quarter? It’s been at a similar level. So what is actually, you know, 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 Diotropium? Market share gain?
Ranesh Swaminathan
Yeah, the team has additional efforts around offsetting some of the cost 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% plus. But the Medicare Medicaid is where we are starting to see some benefits, but it’s not showing in the numbers as of yet. But 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 Medicaid Medicare channel. But on the commercial channel you are broadly maybe at optimum level. Is that the way to look at this? Okay, okay, that’s helpful. Thank you.
Damayanti Kerai
Thank you.
Vinita Gupta
Thank you.
operator
The next question is from Neha Manpuria from Bank of America.
Unidentified Participant
Thanks so much, Ravi. My first question is on Compactin. 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 on Tel avtin. So is that still the case or have you seen additional traction on the specialty contracts? And you know, that market share could be higher. So it is hard to predict. I mean right now we’ve got good ramp up with the within the specialty channel, but it’s still building, the conversion is still taking place. So I think that what you see is the, you know, the impact of couple of months of starting to build the share, but we should be able to see more of an impact in Q2 and Q3. So the, the full contracted share will probably reflect exit of second quarter or third quarter. Would that be a fair assumption?
Vinita Gupta
Yes. Okay. And given that there is no tentative approval for televactin, is it fair to assume that, you know, we could probably have a longer tail for ton versus let’s say a usual FTF product. We hoping, you know, if we had estimated that we’ll have additional competition in six months. But if we don’t see it or if it’s limited, you know, one instead of two, perhaps, you know, there’s more of an upside. And in any case, even with additional competition, we expected a longer tail. Given that it’s a specialty product. It’s, you know, the specialty channels and the physicians don’t like to change patients over and over again to a new product.
Unidentified Participant
Okay, understood. And my second question, Glucagon. While your press release mentions, you know, just the genetic market, I mean the, you know, IQVR market for the generic in the brand. They’re also 505B2 in glucagon. So would it be, it wouldn’t be fair to assume that, you know, our generic would be able to probably, you know, even look at that, that part of the market, the 505B2, or do you Think it’s just restricted to the, you know, the generic products and the brand.
Vinita Gupta
Yeah. So we’re targeting the entire market, but we’ll know as we in the next couple of months how much of a share you can take of the whole market.
Unidentified Participant
Understood. Okay, thank you so much.
Vinita Gupta
Thank you.
operator
Thank you. Neha. The next question is from Sham Srinivasan of Goldman Sachs.
Shyam Srinivasan
Good evening. Thank you for taking my question. I think the opening remarks you talked about potential new, new generic entrance on Albatrol. Right. So is there something that we need to worry and also from your competitive study or market study, how far these other generics. One says Pariba, perhaps?
Vinita Gupta
Yeah. So Amphastar has entered the market, you know, on Albitrol, 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 is hard to say. You know, companies like Alvogen and Teva, if they’re going to get to the finish line on a timely basis. So, you know, we hope it takes them as long as it took us five years to get approval.
Shyam Srinivasan
So Vinita, safe to assume another at least 12, 18 months of like Runway for us?
Vinita Gupta
I would think so.
Ranesh Swaminathan
Okay, that’s very helpful. Just a second question on biosimilar, since you have been starting to be more vocal, you have done an agreement on Zentiva, so late entrant, especially into us, not necessarily Europe, but us. 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. So is there some different entry strategy we might be doing as a, as a follower, second wave? And how do we prepare for the 2029, 2029 kind of wave of the next biosimilars?
Vinita Gupta
Yeah. So I think while we are a late entrant, just given the market evolution, we may not be a late entrant. You know, you’re just seeing substantial kind of easing on market access in the last 612 months. Right. With Humira and the private labels that have come into market, like the Cordavis label, the Qualit label, they certainly have demonstrated the impact that some of the major customers can have with the private label strategy into the marketplace. So 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, Pegfil Braston, 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 genetic 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 27 and 28 can be good drivers of growth for biosimilars for us, just given the limited number of competitors. And then in 29, we expect Eternacept, we’re going to be likely one of four.
And 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. So I’d say. And then we have a pipeline that we were pursuing. I mean there’s such a Lizum app that we are developing. We are going to start development, clinical development of citalizumab soon. We have respiratory biosimilars, mebalizumab and benralizumab that help us serve multiple markets, multiple geographies, not only the US but also Europe where we have a considerable position now with leufroback.
And then in India, biosimilars are gaining momentum in our portfolio, especially of oncology and immuno oncology products like pembrolizumab and nevillumab that we are developing for India. So biosimilars is emerging as a platform that is going to have relevance for us in US other developed markets like Europe, Canada, Australia as well as India. So a global platform that, 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.
So we’ll have to be mindful of, you know, portfolio choices that we make because again, it will be, you know, like complex genetics. We want to participate in products maybe in the first wave and we have barriers to entry where we have exclusivity or semi exclusivity is what we’re targeting or we have a market position that we can leverage like ophthalmics or respiratory.
Shyam Srinivasan
Great, thank you.
Vinita Gupta
Thank you.
Shyam Srinivasan
And all the best.
Vinita Gupta
Thank you.
operator
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 Krishnakumar of mk.
Shashank Krishnakumar
Thanks for taking my question. My first one was on Dulera. Are we still on Track for an FY27 launch in this product in the US?
Vinita Gupta
Yes. So we’re expecting to respond to the CRL in fiscal year 26, this fiscal year and hopefully by the second half of fiscal year 27 or early 28, we should be in the market with Duodera.
Shashank Krishnakumar
Got it, thanks. Second question was on the India business. I think in licensing share obviously has come down to mid single digits now. 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 on.
Vinita Gupta
Sure. So I think the index, 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 high of I think more than 20% at one point of time. The focus remains, I think, you know, for example even on GLP ones on other products there is intent to in license as a. There’s a rich funnel. But 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. I think that will remain the primary focus obviously for the right kind of products. We would still want to in license.
Shashank Krishnakumar
Thanks, that’s helpful. If I could just squeeze in one more. Vinita, I think you mentioned about phase 3 trials in the US for Namaskla but I think there has been a slight delay in phase three. So is it largely a function of patient recruitment or has there been any other chapters that.
Vinita Gupta
No, it has been patient recruitment that has been slow. So we are looking to actually open some new centers as well.
Shashank Krishnakumar
Got it. Thank you. That’s helpful. All the best.
Vinita Gupta
Thank you.
operator
Thank you. Shashank. The next question is from Tushar Manudane of Motila. For the opportunity. Am I audible?
Tushar Manudhane
Yeah. Could you speak up a little bit? We can’t hear you clearly. Is this better?
Vinita Gupta
Yeah. So just on Lutide while you know there is authorized generic as well as couple of more approvals already. So you know how to think about this opportunity for. Us strategically. I mean, you know one of our first few injectables, first product out of India for so starts creating a reputation for Lupin on the injectable front and still a sizable product with you know, a third entrant into the market potentially, you know, in October. We look at it as a sizable opportunity. And also add to that, you know, with Saxenda potentially coming to market in the following year because it’s a very similar product. Victor and Saxenda.
Tushar Manudhane
Ma’, am, with respect to Respital Consta, the gold date being September 25th, is this to do with certain queries to be addressed and which is where the timeline is? September 25th, if you can just you know, elaborate on that aspect.
Vinita Gupta
Yes, we had a couple of information requests based on which the gold date was moved to September. So and we have, you know, responding to them, we have responded to them effectively. So we believe we are in track for September.
Tushar Manudhane
Okay. This would be like, like this is a broad idea in terms of, you know, how many times or how many queries typically USFK would sort of give for such complex product before getting the final, you know, it’s hard to predict.
Vinita Gupta
I remember we had like looked at Theotropium. We had like at the 18 queries, you know, so. But we are hoping that we are the tail end with Rispital Consta and. Just lastly on turbopton in the past there has been certain tentative approvals. So is it not going to be competitive post 180 day exclusivity? We haven’t seen any tentatives so far.
Tushar Manudhane
Okay, thanks. Thanks. That’s it from my show.
Vinita Gupta
Thank you.
operator
Tushar, a follow up question from Kunal Dharmisha of Macquarie.
Unidentified Participant
I thank you for the opportunity. Again, just few clarification on the pricing comment. Ramesh, you said that it’s a low single digit. There it is excluding albuterol impact or including albitrol impact? Including, including arbitrary. Okay, that’s great. Secondly, on Toluapton, is it our own REMS or is it a shared REMS with the innovator?
Vinita Gupta
You know we don’t want to share that. It’s confidential.
Unidentified Participant
Sure, sure. And then thirdly, in terms of SEMA Canada, has your partner’s filing been accepted by the Canadian authority?
Vinita Gupta
No, it’s still in the works. It hasn’t been filed as of yet.
Unidentified Participant
Sure. And 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?
Vinita Gupta
We wouldn’t want to talk about that. Okay, sure. Thank you.
operator
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 Sahin of Nomura.
Unidentified Participant
Thanks, Ravi. Thanks for taking the follow up. Just, you know, few product specific questions. Vinita, you had mentioned about a product called Dalba Vancine some time back. Is this expected for launch this year?
Vinita Gupta
Yes.
Unidentified Participant
Okay. And the other question is on GLP1, you know, if I heard you correctly, you said Victoza generic in September, is that right? For the US Is what I talked about.
Vinita Gupta
Yeah. Neuroglutide, Victoza. Yeah. Approval in September, launch in October, likely.
Unidentified Participant
Okay, okay, sorry. Launch in the next week. September was really hospital constant. That’s what I was talking about. Okay, okay. Victoza, like next year is what you’re expecting?
Vinita Gupta
No, Victoza has just got approved.
Unidentified Participant
Oh, sorry, Saxenda Next year. Sorry.
Vinita Gupta
Yeah, it’s confusing.
Unidentified Participant
Yeah. So Saxenda, you’re expect. Just to clarify, Sax, you’re expecting this year approval FY26.
Vinita Gupta
We are hoping that we get approved sooner rather than later. I mean, the goal date is into next year, but now that we’ve got the Victoza product approval, we hope that the FD is going to expedite.
Unidentified Participant
Okay. Given that, you know, you’re one of the few companies which have been able to get an approval for a GLP1 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? You know, is there any takeaway for Semaglutide or. These are completely different products. And 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.
Vinita Gupta
Yeah, I think that it’s fair to say Lyraglutide 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. So, you know, we think that the competitive dynamics there might be a little bit different than we had earlier expected. I think what it does also it gives us a lot more capability, it gives our people a lot more confidence to be able to develop other products in the GMP1 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.
Unidentified Participant
Okay, you mean fiscal 27.
Vinita Gupta
Yeah, FY27 for the oral. FY20 end of FY26 for the injectable. You know, we’re a large metabolic player. So obviously from that perspective this is it’s very interesting. You know there will be competition but I think we should be able to get more than our more than typical share.
Unidentified Participant
And do you see any risk of delay launch from a regulatory standpoint in India for the injectable?
Vinita Gupta
So nobody’s got it yet. Right. And everybody you know it’s under development across the board. So I think there could be but I you know I think better than even chances of it coming through at that time.
Unidentified Participant
Understood. Okay. Okay, thanks. Thanks a lot.
operator
A final reminder to all participants who want to ask questions, please raise your hand in the participants tab since there are no no further questions and I would hand it over to the conference over to the management for closing comments.
Vinita Gupta
Thank you, Ravi. I hope we were able to respond to all your questions. You know, and I know a number of questions on a portfolio and portfolio evolution as well as a growth prospect. 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.
So look forward to continuing the momentum and connecting with you again over the next couple of quarters. Thank you.
operator
Thank you very much on behalf of Lupin Ltd. This concludes our conference. Thank you for joining us and you may now exit the WE webinar.