LUPINNSEQ1 FY2026August 11, 2025

Lupin Limited

7,112words
82turns
11analyst exchanges
4executives
Management on call
Vinita Gupta
CEO, LUPIN LIMITED
Nilesh Gupta
MANAGING DIRECTOR, LUPIN LIMITED
Ramesh Swaminathan
EXECUTIVE DIRECTOR, GLOBAL CFO, HEAD OF IT AND API PLUS SBU, LUPIN LIMITED
Ravi Agrawal
INVESTOR RELATIONS AND M&A, LUPIN LIMITED
Key numbers — 40 extracted
330 basis point
t growth in both revenues and profitability. Our margins have shown further improvement, rising by 330 basis points YoY, even as we increased investment in R&D by 151 basis points during the same period. Looking
151 basis point
own further improvement, rising by 330 basis points YoY, even as we increased investment in R&D by 151 basis points during the same period. Looking ahead, we are confident that this growth momentum will continue
24%
t 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 U.S. business. We successfully
25%
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 U.S. business. We successfully launche
150 billion
uch as injectables, respiratory, biosimilars and 505(b)(2) products, targeting brand sales of USD 150 billion. We expect complex products to drive a significant portion of our growth and future business. Addi
7.8%
ialty business, both organically and inorganically. Coming to India region, we reported growth of 7.8% YoY. Within this, our India Formulations business recorded growth of 8.6% during the quarter, in l
8.6%
n, we reported growth of 7.8% YoY. Within this, our India Formulations business recorded growth of 8.6% during the quarter, in line with IPM growth. While key therapies like Cardiac, Gl and VMS grew ahe
64%
ke Cardiac, Gl 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
65%
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
18.5%
ur growth rates. I'm particularly heartened by our Respiratory franchise performance, which grew 18.5% as against a category growth of 12.2% during the quarter. Also on MAT basis, the volume growth has
12.2%
artened by our Respiratory franchise performance, which grew 18.5% as against a category growth of 12.2% during the quarter. Also on MAT basis, the volume growth has been 2.8%, double the volume growth i
2.8%
ainst a category growth of 12.2% during the quarter. Also on MAT basis, the volume growth has been 2.8%, double the volume growth in IPM during this period. During the quarter, we successfully complet
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Guidance — 20 items
Vinita Gupta
opening
“We expect complex products to drive a significant portion of our growth and future business.”
Vinita Gupta
opening
“The introduction of new products will be pivotal to our growth with more than 80 product launches planned over the next five years.”
Vinita Gupta
opening
“In addition, we are deepening our presence in Gl, aiming to establish this as our fourth major therapy area.”
Vinita Gupta
opening
“These initiatives will require increased investment, as we have indicated previously, and we anticipate R&D spend to be between 7.5% to 8.5% level in FY26.”
Ramesh Swaminathan
opening
“Looking ahead to FY27, we expect to bolster our momentum with key launches from our biosimilars pipeline in the U.S as well.”
Ramesh Swaminathan
opening
“Sales Sales for Q1 FY26 came in at INR 6,164 crores as compared to INR 5,514 crores in Q1 last year, a growth of 11.8% YoY.”
Ramesh Swaminathan
opening
“Within this, the prescription business grew by 8.6% YoY during Q1 FY26, in line with IPM growth.”
Ramesh Swaminathan
opening
“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.”
Ramesh Swaminathan
opening
“Other Operating Income Other Operating Income at INR 105 crores has increased by INR 18 crores as compared to the first quarter of FY25.”
Ramesh Swaminathan
opening
“Gross Margins Coming to the profitability, Gross Margins continued their upward trajectory with Q1 FY26 Gross Margins at 71.3%, up from 68.4% in Q1 last year, and up from 69.7% in Q4 FY25.”
Risks & concerns — 12 flagged
This was offset by low generic single-digit price decline in our base products and anticipated impact of new generic competition in Albuterol.
— Ramesh Swaminathan
This exposure has notably improved from a classification of “Severe Risk” in 2019 to “Medium Risk” in 2025.
— Ramesh Swaminathan
What would be the current drag from the adjacency business like diagnostics, etc., in this quarter particularly?
— Kunal Dhamesha
What are the specific products, if you would like to highlight, that can help you mitigate the impact of decline in these products?
— Vinita Gupta
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, price increase to offset the impact of tariff.
— Vinita Gupta
So, a combination of all of those measures, we expect to be able to mitigate a good percentage of the impact of tariffs.
— Vinita Gupta
So, 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
— Vinita Gupta
Ramesh, you mentioned there was some 1% drag due to adjacency in India.
— Ramesh Swaminathan
So similarly, can you quantify if there are other such drag on margins which are right now due to some investment or scale-up which are underway and then you expect these things to go away in few years or few quarters?
— Ramesh Swaminathan
So, I think what you see is the impact of a couple of months of starting to build the share.
— Vinita Gupta
We've seen some impact of that you also see in the quarter that we had anticipated.
— Vinita Gupta
And do you see the risk of delayed launch from a regulatory standpoint in India for the injectable?
— Saion Mukherjee
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Q&A — 11 exchanges
Q
What would be the current drag from the adjacency business like diagnostics, etc., in this quarter particularly?
Ramesh Swaminathan
So, the impact on our EBITDA would be close to about 1%. They are still evolving and coming up very nicely. So, the long term obviously looks very alluring to us. But clearly, they're still loss-making at this stage.
Q
Can you help us understand how to look the U.S. sales in FY27? In FY26, it is going to be good because you launched Tolvaptan, etc. But in FY27, there may be a cliff, as products like Tolvaptan, Mirabegron, etc., that may not be as big as they are in FY26. So how to look overall sales in FY27, especially for the U.S? What are the specific products, if you would like to highlight, that can help you mitigate the impact of decline in these products? So, 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 tent
Vivek Agrawal
So, in FY27, you are aspiring to be like a high single-digit-plus growth on FY26? For the company as a whole. Just one clarity on Pegfilgrastim On Body Injectors. So, have you filed or yet to file this product? Which product that you are expecting first? The normal Pegfilgrastim or the OBI one? I am interested primarily in the OBI. Although the Pegfilgrastim approval will come sooner, we hope to file this during this fiscal year. One question on the cost front, last year the company saved close to USD 50 million, so it would be great if you can highlight what are the targets for next couple of
Q
One question is on this whole tariff scenario. We may see an announcement in the near term. How are you assessing that? Any colour 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
It is of course hard to predict where this lands based on the outcome of the 232 investigations. 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, price increase to offset the impact of tariff. 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 are looking at a potential to transfer those products. We are also considering some IP transfers that of course will have a capital gains impact, but overall
Q
Any update on Semaglutide filing plans in Canada?
Vinita Gupta
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. I meant Canada. Semaglutide in Canada? So that will come through partnered, like Vinita said. Just to clarify on Mirabegron patent litigation. There are, I think, two patents under active litigation, right? And in one of the patents, I think the outcome depends on one of the other competitors, how their litigation
Q
So, my question is on your injectable portfolio build-up. So, first, have you launched Glucagon and Liraglutide in the U.S.? 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. So, why are we waiting until next few months for Liraglutide launch? That's the time it takes to really do the validation and get launch quantities together. And how do you see Liraglutide market in the U.S., given the market in general has moved to the new-generation therapies, your Semaglutide and Tirzepatide, etc.? Do you think this market is still attractive? We believe it is attractive because it's half a billion dollars plus, and there are very limited nu
Q
My first question is on Tolvaptan. I think you had mentioned that based on contracts that we have in place, we should be able to get to about 25% market share on Tolvaptan. So, is that still the case? Or have you seen additional traction on the specialty contracts and that market share could be higher? August 6, 2025
Vinita Gupta
So, it is hard to predict. I mean, right now, we've got good ramp up within the specialty channel. But it's still building. The conversion is still taking place. So, I think what you see is the impact of a 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 full contracted share will probably reflect exit of second quarter or third quarter. Would that be a fair assumption? Yes. Given that there is no tentative approval for Tolvaptan, is it fair to assume that we could probably have a longer tail for Tolvaptan versus a usual FTF
Q
I think in the opening remarks; you talked about a potential new generic entrance on Albuterol? So, is there something that we need to worry? Also, from your competitive study or market study, how far away is other generics on, say, Spiriva perhaps?
Vinita Gupta
So Amphastar has entered the market on Albuterol. We've seen some impact of that you also see in the quarter that we had anticipated. On Spiriva, you have 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, companies like Alvogen and Teva, if they're going to get to the finish line on a timely basis. So, we hope it takes them as long as it took us, five years, to get approval. So, it is safe to assume another at least 12-18 months of like a runway for us? I would think so. Just a second question on biosimilars, si
Q
We're expecting to respond to the CRL in FY26. And hopefully, by the second half of FY27 or early FY28, we should be in the market with Dulera. Shashank Krishnakumar: 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?
Nilesh Gupta
I think the focus on in-licensing remained all this while. But obviously with the LOE’s and competition, that share has just been coming down. It's now down to 6% from a high of more than 20% at one point of time. The focus remains for example, even on GLP-1s, on other products, there is intent to in-license. 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 are making good progress on that. I think that will remain the primary focus. Obviously, for the right kind of p
Q
Just on Liraglutide, while there is authorized generic as well as a couple of more approvals already, so how to think about this opportunity for Lupin?
Vinita Gupta
For us, strategically, one of our first few injectables, first product out of India. So, 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, I'd add to that with Saxenda® potentially coming to market in the following year because they are very similar products, Victoza® and Saxenda®. With respect to 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 Septembe
Q
On the pricing comment, you said that it's a low single digit. There it is excluding Albuterol impact or including Albuterol impact?
Ramesh Swaminathan
Including. Secondly, on Tolvaptan, is it our own REMS? Or is it a shared REMS with the innovator? We don't want to share that. It's confidential. And then thirdly, in terms of Semaglutide Canada, has your partner's filing been accepted by the Canadian authority? No, it's still in the works. It hasn't been filed as of yet. 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? We do not want to talk about that.
Q
Just a few product-specific questions. You had mentioned about a product called Dalbavancin some time back. Is this expected for launch this year?
Vinita Gupta
Yes. And the other question is on GLP-1. If I heard you correctly, you said Victoza® generic in September, is that right, for the U.S.? I talked about generic Victoza® just got approved and will be launched in October. Risperdal Consta® will likely get approved in September. And Saxenda® next year? Yes, next year. So Saxenda you're expecting - just to clarify, Saxenda you're expecting this year approval, FY26? 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 FDA is going
Speaking time
Vinita Gupta
28
Moderator
12
Saion Mukherjee
9
Ramesh Swaminathan
6
Kunal Dhamesha
5
Nilesh Gupta
5
Damayanti Kerai
5
Neha Manpuria
3
Shyam Srinivasan
3
Kunal Randeria
2
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Opening remarks
Vinita Gupta
August 6, 2025 Welcome to Lupin Limited's Q1 FY26 Earnings Conference Call. I am Ravi Agrawal, Head of Investor Relations for Lupin. Thank you for your participation in the call today. Please note that all participants' line will be in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks. Please also note that this conference is being recorded. I now hand over the conference to the management. Thank you, and over to you. Thank you, Ravi. I am very pleased to welcome you to our Q1 FY26 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 YoY, even as we increas
Ramesh Swaminathan
August 6, 2025 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 injectables space, which will further strengthen our complex portfolio in the U.S. Looking ahead to FY27, we expect to bolster our momentum with key launches from our biosimilars pipeline in the U.S as well. Our ongoing commitment is 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 Ram
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