Good evening, everyone. I hope all of you had a great Diwali. I'm very pleased to welcome you to our Q2 fiscal year 2025 earnings call. I have with me our MD Nilesh, our CFO Ramesh, and our Head of Investor Relations, Ravi here. We look forward to sharing with you our highlights for the quarter, as well as outlook for the year ahead. We are very happy to report another quarter of double-digit revenue growth, led by strong commercial execution in our key markets and also backed by new product launches. We are in particular pleased with our EBITDA performance, with 510 basis points improvement year-over-year and 50 basis points improvement sequentially, despite higher investments in R&D.
We feel confident of maintaining our growth momentum in the coming quarters, with EBITDA margins in the 22%-23% range for the fiscal, based on our business momentum and continued focus on driving efficiencies. Our U.S. business performance was strong this quarter, with volume-led growth in inline products and strong performance in our respiratory portfolio, offsetting additional competition in products like Suprep and doxycycline. With the recent successful launch of mirabegron 50 mg and Pred Forte with the CGT exclusivity, we feel confident of delivering close to double-digit growth in the U.S. this fiscal. Also, we have continued to improve our profitability in the U.S., led by better product mix and higher efficiencies in the base business. We are very optimistic of our long-term growth strategy in the U.S.
So far, we have evolved our business to 40% complex generics, and we have an exciting pipeline with more than 20 respiratory products, 40 injectable products in development that we believe will enable us to continue to drive the shift to 50%+ in the next couple of years. Coming to India, we reported strong growth of 19% year-over-year, led by growth in our India formulations business and additional tenders in our global institutional business. Our India formulations business recorded growth of 10.9%, 40% ahead of the market. For H1, our growth was 30% ahead of the market, so very strong momentum in India. Volume growth in the quarter was a strong 3.5%. I'm happy to report that all our key therapy areas - cardiac, respiratory, diabetes, and GI - grew ahead of the market.
I would like to specifically call out our diabetes portfolio, which was challenged in the past due to loss of exclusivities on brands. Our diabetes business now grew 19% year-over-year, against a category growth of 9% in the quarter. We feel confident on continuing to deliver above-market growth in our India formulations business, backed by a strong portfolio of innovative and licensed products and an extensive reach through our 10,000-person sales force. Our non-U.S. developed markets grew 20% year-over-year, driven by strong growth in key markets like Canada, the UK, and Australia. Growth was contributed by both inline products like Zaxine in Canada, Luforbec, our Fostair generic in the UK, as well as new product launches. We also witnessed healthy growth in our key emerging markets like Mexico and South Africa during the quarter.
On R&D, as planned, our R&D as a percentage of sales has increased to 8.2% during the quarter. We successfully completed phase III for our ranibizumab biosimilar this quarter, which paved the way for us to file the product in the U.S. and EU this year. We expect R&D to be around INR 1,800 crores for fiscal year 2025, with an increasing percentage of complex generics as planned, primarily in the respiratory as well as injectables platforms. From a compliance perspective, we have submitted our responses to the recent FDA audits at our Pune Biotech and Pithampur Unit 1 facilities. We would like to reiterate that we are committed to ensure that all our sites are fully compliant with U.S. FDA and other regulatory agencies around the world.
Before I hand it over to Ramesh, I would like to say that we remain very optimistic on our growth potential, both in the short and medium term. Our strategic growth levers are well-defined and backed by an exciting pipeline of products in our chosen markets and key therapy areas. We are committed to driving efficiency measures while leveraging our investments across all major geographies. We are confident on building on our momentum, both in terms of top line and profitability going ahead. With this, I will hand it over to Ramesh.
Thank you, Vinita. Friends, I welcome you all to our Q2 FY 2025 earnings call. I'm happy to announce that we have delivered another quarter of consistent double-digit revenue growth across most of our geographies. We have also increased our EBITDA margins despite an almost 190 basis points QoQ increase in our R&D spends. Diving into the numbers, sales. Sales for Q2 FY 2025 came in at INR 5,497 crores as compared to INR 4,939 crores in Q2 last year, a growth of 11.3% year on year. On an H1 basis, sales came in at INR 11,011 crores besides INR 9,681 crores last year, a growth of 13.7% year on year. We have registered robust growth across most of our key geographies. India business has grown 19% year on year. North America has grown 6% year on year. India grew 20% year on year.
Growth markets grew by 12% year on year, while API grew 10% year on year. The U.S. business. In the quarter, the U.S. business recorded sales of $220 million, a growth of 3% year on year on a constant currency basis. As Vinita mentioned, volume growth in our base products and increased sales of respiratory products were offset by increased competition in products like Suprep and doxycycline and low single-digit price declines. We also had impact of high channel inventory for some of our new product launches, which will get normalized going ahead. Based on our visibility of new product launches like mirabegron 50 mg and Pred Forte, among others, we are confident of meeting our guidance of close to double-digit revenue growth in the U.S. for this fiscal.
We also continue to execute on our strategy to improve our profitability in this segment, with another quarter of high profitability from this business. On a long-term basis, we remain confident of consistent delivery of profitable growth for an increasing share of complex products in our portfolio. Coming to India, the India business grew by 18.8% year on year during the quarter. With this, the prescription business has grown 10.9% year on year, outperforming IPM growth by 1.4x during the quarter. Even on an H1 basis, the prescription business has grown at 10.8%, handsomely outperforming IPM by 1.3x. Our chronic segment has grown 13.5% year on year during the quarter, against an IPM growth of 9.7%. If you look at our top three segments of cardiology, diabetes, and respiratory, they have handsomely outperformed their individual category growth within the IPM.
I would also like to mention that as per IQVIA, Lupin is ranked number three insofar as new product introductions are concerned. The share of in-licensed products is around 12% as compared to 15% last year, which also has a positive impact on our profitability going ahead. I would like to mention that in our India region, outside the India prescription business, our adjacencies and domestic part of our global institutional business have also performed well in this quarter, with revenues of 208 crores versus 66 crores in Q2 last year. Insofar as other businesses, revenues in our ex-India, ex-North America formulations business, which includes EMEA, ROW, and growth markets, have increased 10% year on year to 1,222 crores and now constitute 22% of our sales.
Insofar as EMEA is concerned, which constitutes our EU region and South African business, we registered strong growth of 20% year on year during the quarter. This has been driven by healthy growth in EU markets like UK from Luforbec and other products. Growth markets. Our growth markets include the APAC and LATAM regions, which have grown 12% year on year during the period. The APAC market grew by 10% year on year during the quarter, led by strong growth in markets like Australia. LATAM market grew 14% year on year in the quarter due to strong growth witnessed in Mexico. Coming to the P&L aspects, other operating income of INR 176 crores has increased by INR 76 crores this quarter. This is mainly due to PLI and other export benefits during the quarter. Gross margins.
Coming to the profitability, Q2 FY 2025 gross margins were 69.3%, up from 68.4% in Q1 and 65.5% recorded in Q2 last year. The improvement is driven by multiple factors, which include product mix, tailwinds on input cost, lower share of in-licensed products, increased volumes, and various cost improvement and efficiencies, which we have undertaken over the past several quarters. Barring any unforeseen circumstances insofar as geopolitical uncertainties in the Middle East are concerned, we feel confident of maintaining our gross margins around these levels going ahead. Employee benefit expenses at INR 1,007 crores increased 17% year on year from INR 861 crores in Q2 FY 2024 and INR 971 crores in Q1 FY 2025, translating to 18.3% of sales besides 17.4% last year and 17.6% in Q1 FY 2025. This change is largely attributable to higher costs attributable to regular annual increments, and this is growth during the period. Manufacturing and other expenses.
Q2 FY 2025 manufacturing and other expenses came in at INR 1,667 crores, which translates to approximately 30.3% of sales as compared to 31.4% of sales in Q2 last year and 29% of sales in Q1 FY 2025, reflecting a growth of 7%. The expenses are mainly due to higher R&D costs and some extraordinary provisioning leading to some disputes. R&D is at INR 448 crores, which is 8.2% of sales in Q2 FY 2025 as compared to INR 350 crores at 6.3% of sales in Q1 FY 2025. Almost two-thirds of R&D is directed towards complex portfolio. For the full year, R&D is expected to be around 1,800 crores. EBITDA excluding Forex and other income was 1,308 crores versus 923 crores, an increase of 42% year on year, with margins of 23.8% versus 18.7% last year in the same period. On a quarter-on-quarter basis, margins have expanded by 50 basis points.
This margin expansion is on the background of higher R&D spends, which have increased by 190 basis points quarter-on-quarter during this period. If we look at our EBITDA margin profile, we made improvements across all our key segments. Our gross margins are higher by almost 1% quarter-on-quarter, and there has been an increase in the operating income, and we have benefited from cost savings all over. We also made additional provisions of INR 58 crores for an ongoing dispute. Putting this all together, we believe that we should be able to deliver EBITDA margins in the range of 22%-23% for the remaining fiscal. On the tax line, our ETR is 18.7% during H1 FY 2025. The full year, we expect it to be around 20%-21%.
Insofar as the balance sheet is concerned, operating working capital was about INR 6,562 crores as of 30 September, against INR 5,691 crores in March 2024, which translates to 107 days of net working capital against 105 days as of 31 March 2024. Net debt is about INR 274 crores against INR 477 crores in March 2024 again. While we focus on increased cash generation from our business, we'd like to highlight that we continue to actively explore strategic allocation of our capital, where there's a long-term growth vision of the company. On the ESG front, Lupin has achieved an S&P Global ESG score of 76 in the recent round of assessments from the concerned body, the industry average being just about 30 in the pharmaceutical sector. Our S&P score reaffirms our commitment to prioritizing sustainability and creating impact on sustainable healthcare solutions that benefit patients and communities worldwide.
Seven of our Indian manufacturing sites got successfully reassessed for human rights assessment, with five sites retaining platinum rating and two others for gold, moving from gold to platinum. With this, we open the floor for discussions.
Thank you so much, sir. We will now begin the question-and-answer session. Please raise your hands from the participant tab on the screen to ask questions. We will wait for 30 seconds for the queue to assemble.
Okay, so we'll take the first question from Saion Mukherjee.
Yeah, hi, thank you. Hope I'm audible.
Yes, you are.
Yeah, thank you. So my first question, Vinita, is that for future launches, we talked about injectable glucagon and dalbavancin. Can you just talk to us about the visibility of these launches and what kind of upside you're expecting from these products?
Yeah, so injectables right now are a very small part of our portfolio, so we're looking forward to these approvals. We expect glucagon and dalbavancin in the next couple of quarters. One may be in Q4, and I think one might slip into Q1 of next year. But over the next couple of quarters, we should be seeing these approvals, plus risperidone we expect in the next fiscal year, and potentially also liraglutide Victoza we expect into the next fiscal year. So we really see the injectables portfolio building very nicely starting the end of this fiscal year through the next fiscal year on top of our respiratory and other exclusive orals.
Thanks, Vinita. Particularly on dalbavancin, is that an exclusive product for you? How are you expecting competitive intensity here?
We see a couple of competitors, but still limited in number compared to other injectables.
Okay, okay. The second question I have was on the India and emerging market opportunity on the GLP-1 space. So if you can take us through what you're thinking about India and other emerging markets, what are your preparedness and how you're seeing this opportunity?
So go ahead, Vinita.
So, I think it's essential that we bring this as a leading cardiometabolic company. We're ranked number two. Obviously, we want to bring these products to the Indian market as well. We believe that we aim to be in that first wave of generics coming into the market. So likely in 2026, we would hope to launch the first of several. I think everybody is chasing a whole bunch of products at this point of time. So I think there is importance to bring this sooner rather than later. But I think short answer, 2026, we hope to launch the first of these.
I'd say just add to that, also other emerging markets, we have positioned ourselves to either partner the product or internal development to contribute to the market when it opens.
Okay, thank you. I have more questions. I'll join back. Thank you.
Thanks, Saion. So we'll take the next question from Neha Manpuria.
Yeah, thanks for taking my question. Ramesh, in your opening remarks, you gave us several reasons for the gross margin improvement that we have seen. And I think that you mentioned you expect the gross margins to maintain at these levels. So would that be in the first half range that you're seeing in the 69%-70%, or the quarter? Just wanted to get a sense on that.
Yeah, 68%-69% is a good range you can sustain for the future.
Sorry, Ramesh, your voice broke. I think my line of thought.
The 68%-69% range is what I was referring to.
Understood. Understood. And what, according to you, has been the biggest driver for the margin improvement that we have seen in the first half? Is it product mix? Is it the input cost? If we were to pin down the top two areas where you've seen the most improvement?
I would actually say three things. One is, of course, the sales mix. mirabegron's background, of course, contributed there. The second is essentially the procurement cost. So they're also coming down, and we expect that to continue to go down in the quarters to come, and the third, of course, there are a lot of operational efficiencies that have taken over time. For starters, the gross margins line itself, we do have firstly alternate vendor development that we have done for key products and so on, key materials, and the second part insofar as, for example, we have air freighting, which has been reduced, and we are now more into the ocean freighting mode. So all of these kind of efficiencies have helped in kind of bringing up the margins to the levels that it has come to.
I think Vinita also mentioned that we are seeing improving profitability in the U.S. Is it fair to assume that the U.S. margins now are higher than our corporate margins?
Yes, absolutely.
Okay. And last, what was the number for the global tender business in the India sales this quarter?
About 66.
No, about INR 150 crores, right?
Yeah.
Okay. Thank you so much.
Yes, partial loan was. Yeah.
Is that okay?
Yeah.
Thank you for your question, Neha. The next question is from Kunal Dhamesha.
Hello?
Kunal, are you there?
Can you hear me?
Yeah, yeah, we can.
Hello?
Hello. Yeah, we can hear you.
We can hear you.
Hello.
Kunal, can you speak up? We can hear you.
Kunal, we can hear you. Yeah.
Maybe you can't hear us.
Yeah.
Maybe the next one.
Can Bino? Bino, you can take the question, next question. Bino. Bino, are you there?
Hi. Yeah, I'm here.
Okay.
Great. Just wanted to follow up on your GLP strategy. Globally, you said 26 starts. And could you give us some sense of when the markets open up globally, not just in the U.S. for the semaglutides, tirzepatide types, etc., especially in semi-regulated markets, etc.?
So, more of the regulated markets are actually patented later. The loss of exclusivity is expected, I think, in 2030 for the developed markets, with the exception of Canada. But India, South Africa, Latin America, Philippines, some parts of Eastern Europe, those are the markets that are available for us to launch in '26.
Okay. And do you have a strategy in place to be in the first wave of launches in these countries?
Yeah, so we have definitely positioned ourselves for India and South Africa. We have a license. So a combination of our internal development as well as in licensing, we have positioned ourselves in all the key markets where we can really participate in the category.
Understood. Second question about your new initiatives on the CDMO space. You have moved earlier in that space, appeared to be some innovators. Now, you have set up a subsidiary. And are you trying to refocus there, especially in the context of Biosecure Act, etc.?
Yeah. So sorry, what's the question?
Question about your strategy in the CDMO space. Are you planning to refocus there?
Yes, of course. I mean, that's exactly why we created Lupin Manufacturing Solutions. Obviously, it's early days. We're putting the team together. I think we've got almost all the entire structure that will fall in place between this quarter and the next quarter. And then, obviously, I mean, I think we need to put our head down and give it a year or two years of good work to be able to talk about this. But we're very optimistic about what we should be able to deliver out of that. I think there's some very positive trends towards India. And I think that opens up the headroom for companies like us to be able to capitalize on this. So very excited with this venture.
But what would be your value proposition versus pure CDMO companies?
I think it is going to be a pure CDMO company in that. I mean, it's a separate company. And everything is structured as such in that. I think if you look at just the variety of technologies that we would have, if you see the understanding of regulated markets, I mean, we're not unique in this. I think there's obviously a few other companies that would be able to do this even out of India. But I mean, we have the ability to play at scale in this space. We believe we have a right to win. I think we understand. Obviously, we understand chemistry. We understand technology. We've done this for years. We understand regulations. We understand quality. And we are getting the right kind of commercial capabilities in place as well, which is key.
I mean, some of the other disciplines like project management and the like are different, and we are obviously building and acquiring capability, but the intent is to play this as a pure CDMO player in that part.
Understood. One last question to Vinita. The U.S. quarter-on-quarter revenue has come down a little bit. And this is despite mirabegron 50 mg being launched almost a month before the end of the quarter. So what has primarily led to that Q2 decline in revenue? I assume that Spiriva has continued to do well from your comments. Is it some fluctuation in the base business or some arbitrary hit?
Actually, the base business has been fairly strong. I mean, there's been some phasing on mirabegron because we had the inventory load in the first quarter for the 25 mg. And for the 50 mg, it was more substitution. So it was not as much of an inventory load. But you'll see that normalize in the second half of the year. And then it was really additional competition and products like Suprep and doxycycline, like I mentioned. We had some erosion there. But the base business, respiratory portfolio, as well as mirabegron from a share perspective, has continued to build in Q2. And it's just the phasing of the inventory load on the mirabegron also that has a little bit of impact between the two quarters.
Got it. Thank you. I'll jump back.
Thanks, Bino. We'll take the next question from Anubhav Agarwal.
Hi, guys. I'm checking on my audio?
Yes, yes.
Yes, yes.
Okay. So one question. I just want to get some more clarity on the specialty business where you had a new president as well last month. So what areas are you trying to focus here? What will be risk appetite? How do you want to build it? Earlier, the company was focused more on the women's specialty area. How are you thinking about it here?
Yeah. So our focus is on the two therapy areas where we have a presence. I mean, right now, we have a small presence on the respiratory front in the U.S. with Xopenex. And in Europe, our franchise is a branded generic franchise. So that is one. And two, neurology. Again, there we have a presence with NaMuscla. In Europe, we are looking to expand that into the larger indication. Right now, it's an NDM. And we have started to conduct a study for DM for global commercialization of NaMuscla, in particular, Europe and the U.S. So the focus is the two therapy areas that we are already present in. And very excited to really have Klaus on board. Brings in tremendous experience. And in particular, in the two areas of our interest, respiratory as well as neurology.
But as an organization, we will build this out in a cautious manner. As we have stated, I think in past interactions as well, we would like to really build with accretive assets in the near term as we continue to really drive our EBITDA margin expansion from the 23% level to the mid-20s and above over the next five years.
So just one subpart of clarity on this question. So do you see yourself or Lupin basically acquiring mid-size assets here, $100 million, $200 million kind of assets, booking of about three, four products over a period of three, five years? Or is that the way when you say cautiously build this up?
Yeah. So we'll look at medium-sized assets that can really help us build the business as well as our own organic portfolio with the capabilities we have on the respiratory front. We're building a pipeline of green propellant products where we hope to be in the first wave along with the other brand companies. We have our own brand in Xopenex, so we have that opportunity. So a combination of mid-size acquisition opportunities that make sense for us as well as organic builds with a pipeline.
Sure. So then on the US generic business one, on generic Spiriva, I'm just trying to understand the market share is largely around 30%. So I'm assuming there is no production constraint. This is just your reading of the market. You're trying to maximize your potential here. So should we assume that till the time the next player comes in, which could be fiscal 2027 or thereabout, would you largely remain around 30%? Or what would trigger this 30% to go to 35 or 40%?
Yeah. So right now, we have kind of stabilized at that 30% level. And the brand has held on to 70% share. I mean, when we look at the different channels in the marketplace, in the commercial space, we have more than 50% share. But in the Medicare/Medicaid space, our market share is lower. That's what's driving it down to the 30% level. So we have efforts ongoing to expand the awareness and try to help conversion in the Medicare/Medicaid business. And hopefully, can drive that over the next couple of quarters to the mid-30s. But right now, we have stabilized at a 30% level.
In the commercial space, you think 50% is an optimum level? Or that could be 60%-70% as well?
Yeah. We're already above that 50% level in commercial.
Okay. Just last question on mirabegron. I saw that Astellas got expedited review approval from the Court of Appeals. So not the outcome, but the total process of litigation, can we assume that this gets done either way in a couple of quarters from here? Or could this be extended and extend to, let's say, a year from here?
Yeah. So it's really hard to predict that. At this point, the case was remanded back to the district court. And I'm sure that the brand, whatever the outcome is, is going to likely challenge us if it's not in their favor. So it's hard to really predict. But we were pleased that it was remanded to the district court that already ruled in favor of generics.
So what clarity was on the expedited review that Astellas has just got it starting October a month back? Does that have an implication on the timing of the case?
I mean, that's one part of multiple cases which are going on in mirabegron background, right? So this does drag out for well over the next few quarters, any which way.
Sure. Thank you, guys.
Thank you for your question, Anubhav. We'll take the next question from Girish Bakhru.
Yeah. Hi. I mean, just going back to glucagon, I mean, you had commented for maybe Q4 launch. Just wanted to know, is this a kit presentation or a vial presentation?
It's an injectable.
Injectable.
Yeah. But it's a vial in a kit. I think so. But we can get back to it.
I believe we did the kit, but we'll just check.
Sure, sure. Yeah. And I mean, I'm probably also understanding the market is shifting here because I think the use of the product is now shifting mostly to diagnostic chains in the U.S. That's why the vial presentation is probably getting bigger. But I mean, would the market sizes become different as per your understanding?
We don't expect any material shift in the market. Right now, majority of the market is with Amphastar, right? And we expect to be one of few competitors. So it's an attractive opportunity for us the way we're looking at it. We haven't really come across a material market shift here.
Because Amphastar is only selling kits, actually. And vial market is what is actually, I read, that is growing. That's why I was confused what presentation actually would fund focus on.
Why don't we get back to you about that?
Sure, sure. And just on the risperidone, I mean, we have one generic which is already approved. We have a 505(b)(2), I think, already approved. I'm not sure if it's too early to call out whether the shift from brand to these newer players is happening already in the market at an expected pace. But is this going to be a product which is very difficult to shift the prescriptions from, from the brand to generic?
I understand that the 505(b)(2) has been slow uptake from at least in the last couple of quarters. We still expect in the near term for this, the primary product to which we have a generic, to be a material opportunity for us.
Teva is already in the market, I'm guessing, and there also, numbers are pretty low right now.
Yeah. But Teva also has the 505(b)(2).
Yeah, yeah.
Right? So they have both the 505(b)(2) as well as the generic. We don't know how they are positioning each.
Understood. All right. Thank you.
Thanks, Girish. We'll take the next question from Damayanti Kerai. Damayanti, can you hear us?
Yeah. Yeah. Hi. I hope I'm audible.
Yes, yes.
Hi. Thanks for the opportunity. My first question is clarification on other operating income. So Ramesh, did you mention INR 76 crore of PLI and other export benefit? Or number is something different?
Yeah. That's what I meant. It's a higher quantum.
76.
It has increased by INR 76 crores during the quarter.
Increased from which level? Just you can just quantify for the second quarter, please. How much is that?
You take it for the full quarter. It's INR 76 crores higher for the.
Quarter. And it was INR 50 crores for the previous quarter.
Yeah. Just 165 crores in the previous quarter in this quarter and 86 crores in the previous quarter.
Okay. Understood. That's clear. Great. My second question is for Vinita. So can you also update us on your respiratory pipeline in terms of which key assets are due for filing or approval in, say, next two to three years?
Yeah. So we have a few nasal sprays that should get approved in the next two years. We have Dulera that we are actually in the process of doing additional studies to be able to respond to the agency. We hope to be able to respond to the agency in the next fiscal year. So that should be, hopefully, fiscal year 2027, 2028 opportunity for us. And then in the current fiscal year, we have multiple products in development. But the major ones, both the Respimat and Ellipta products, we have planned exhibit batches before the end of this fiscal year. So have made significant progress there as well.
Sure. And most likely, these Respimat and Ellipta products are, say, 2027 and beyond opportunities? Or it could be earlier also?
No. It won't be earlier because we'll have to certify against the patents as well.
Okay. That's helpful. My last question is on GLP opportunities, which you mentioned. So just want to understand in terms of capabilities, which are your key areas of strength? And will you be manufacturing it in-house to supply to global market? Developed markets will come later. But once you start in 2026, so manufacturing will be in-house or it will be done through CMOs?
So for products like semaglutide, obviously, we would do it in-house because we obviously have both oral and injectable capability. For other products, I think it all depends, right? It depends on the alliance that we would try to seek and the like. So I mean, everybody's chasing multiple products at this point of time. Some of them may be just simple in-licensings. Others is when we could manufacture, we would love to be able to manufacture as well. I think that strategy will really play out in the next year. And we'll have more clarity at that time.
It will be mix between in-house and maybe depending on market opportunity.
Right.
Yeah.
Okay. That's helpful. Thank you.
Thank you for your question. We'll take the next question from Kunal Randeria.
Hi. Good evening, Vinita. My question around liraglutide. Given that the drug is not as efficacious as semaglutide, has higher dosing frequency, and now there is already one AG in the market with few more lining up, just wondering how do you see this market shaping up in the future?
I mean, while semaglutide and the follow-on products obviously is where the market has moved to, liraglutide is still a substantial market, both Victoza and Saxenda. So we still look at it as a billion-dollar-plus market with hopefully staggered entry of players. So we're looking forward to the approval.
So do you think there'll be a sharp price erosion and then at the same time, the volumes could go up?
I mean, that could be a scenario. I mean, it's hard to predict, but we are chasing the applications with the FDA to be able to hopefully get into the market next year.
Got it. Okay. Now, my second question is around albuterol. Now, you did make some reference to your share being low in the Medicare setting. I guess the brand share is very high over there. So with this $2.
Certainly. I was talking about Spiriva.
Okay. Sorry. Go ahead.
It was in reference to tiotropium, not albuterol.
Oh, sorry. But okay, let me ask on albuterol then. But even in albuterol, in the Medicare setting, the share of the brand is pretty high. So how do you see this Medicare $2 per month out-of-pocket thing playing out for generic companies like yours?
We really don't see any potential impact of the $2 program because it's more to cover the out-of-pocket costs for patients, right? So it's the planned coverage, and if anything, I believe that it can potentially expand usage of the drug if the product is available at a low out-of-pocket cost to patients. We really, as far as albuterol goes, the substitution in albuterol is pretty strong from a generic perspective. As you know, even the brand companies have launched authorized generics on the product, so a good 80% plus of the market is really with authorized generics and generics.
Even in the Medicare setting?
Yes.
Okay. All right. Thanks.
Thanks, Kunal. We'll take the next question from Shashank Krishnakumar. Shashank, are you there?
Yeah. Hi. I'm audible.
Yes.
Yeah. Hi. Thanks for taking my question. My first question was on the margin front. So given the trajectory of gross margins and other expenses, is there any rethink in terms of the medium-term margin aspirations or the medium-term margins that we are guiding to? I think I heard 20%-23% this year. Beyond FY 2025, what are we looking at margins?
There are two aspects to this. Obviously, we believe that our core should be in the range of about 23%-25%. And that is something that we would get to in the medium term. And so there's this aspect of adjacencies also, which actually some of these are still loss-making in the current context, which should obviously spin on their own axis in the next couple of years because we intend spinning it off and bringing in private equity to kind of participate also. And they would, of course, have grown and become more profitable as well. If you were to knock out the impact of the adjacencies, you would actually have an EBITDA margin higher by about 0.8% given this particular quarter itself. It's coming down for sure. Versus the previous quarter, for example, and steadily becoming more profitable.
That would really alter in the next couple of years.
Thanks. Thanks. That's helpful. Secondly, just wanted to check if this quarter so far in albuterol, have you seen any impact of Amphastar's launch? Though the company has been saying that they themselves don't expect meaningful contribution this quarter, but have you seen any impact so far?
No, not in this past quarter.
Thanks. That's it.
Thanks, Ramesh.
No, I also wanted to clarify something on. There's so much of patience around, in fact, the PLI and the like as well. The scheme provides for INR 1,000 crores over a period of five years, as all of us know this. So that actually roughly means about INR 200 crores. But it also actually provides for an exception where you could actually take a quantum a little more during the course of one particular year. It's an exception really to the framework. And we've taken advantage of this this year because of the fact that there's a surge in terms of exports and the like. And obviously, money into the kitty much faster is always better for us.
That's the reason why you would find a higher quantum of PLI monies coming in this year, but doesn't necessarily mean it's going to be the same quantum spread over the next several years.
Thank you, sir. We'll take the next question from Kunal Dhamesha.
Can you hear me?
Yes, we can.
Sure. So thanks for the opportunity. The provision of INR 58 crore, what is it related to, and how should we think about it? Is there more liability that can come for us, or this is?
This is a measure of abundant caution, so to speak. As with every company, we also have our share of litigation, disputes, and the like as well. So we just thought in the goodness, in the fitness of things that you provide for something, and that's what it is. And it's just that it's an abundant caution rather than actually you don't need to read too much into it. It's not something you should repeat unless things go horribly wrong or something, which we don't think it'll ever materialize that way.
Which business segment does it belong to geographically?
It's basically a general provision, I would say, attributable to certain disputes.
Sure. And then there is also, when I look at our current provisions, there is almost cash outflow of INR 400 crores between March and year. So what does that refer to?
It's basically we paid out our dividends and the like, right? So from that perspective, you would actually be seeing though it was actually a cash surplus company towards the end of last quarter. But there was, of course, the slight increase in working capital. It increased by about three days, four days. And then it's, of course, the dividends outflow, which has caused this cash outflow.
Dividend. Okay. Okay. And on India business, out of our total revenue this quarter, if you can help us understand the three parts to it, I think one is prescription business, another is a tender business, and then adjacencies like diagnostics, right? So can you provide color on what is the contribution from each?
We don't go into segment-wise. I mean, I wouldn't like to do that at all. But I just tell you about the fact that adjacencies are still loss-making. And this is essentially the diagnostics business and digital. And there's, of course, some parts of OTC and so on. But all of this put together actually impacted the EBITDA margins by about 0.8%. The tender business, of course, is profitable. It gets included because it actually emanates from this particular geography. And that actually increases overall quantum increase this quarter to the growth to about 18%.
And this tender business, would it be a meaningfully lower gross margin business than our India business? Or would it be in line? How to think about it?
We are not actually revealing geography-wise margins. So that question might not be relevant in that sense. But as with every tender business, you would expect, in fact, the gross margins to be lower than the retail business in a general sense.
I mean, just to give nature, I think 90+% is in any case the RX business that we're talking about here.
Absolutely.
But then I don't understand. The total India business growth is 19%, and we are saying RX business growth is 11%. Then a huge chunk is coming from tender. Isn't the way to understand it? Or what am I missing here?
Your question related to sales quantum as well as the profits. We are not talking about segmental profits at all out here.
The sales business.
Yeah. So we're talking about sales 11% increase in India region sales, for sure. There's, of course, the OTC and diagnostics business, which have also gone up over the quarters. And there's, of course, the tender business, which has also been represented in the overall figure of 18%-19% growth at that point.
So in the year on year, the number was very low last year. And the number is a substantial increase. We already talked about the global institutional business being 150 crore in the quarter. Okay. And entire of that flows into India business as we reported?
A good portion of that for this quarter reported into the India business. Sometimes it's export. Sometimes it's domestic. Actually, our press release, in any case, would give you the India region business as well as the India region formulation business, right? So we do get that split.
Sure, sir. Thank you and all the best.
Thank you.
Thanks, Kunal. This is a reminder to request all the participants to raise their hands from the participant tabs. So we'll take a few seconds before and we'll wait for the queue to assemble. So just bear with us. Okay. We're good to go. We take the next question from Alok Dalal.
Yes. Am I audible?
Yes.
Yeah. So Vinita, just to clarify, ranibizumab ANDA filing will be end 2024. Is that correct?
Yeah. This fiscal year.
Okay. And do you expect this to be a first wave launch? You've been in the first wave?
No. No. They already are products ahead of us. But we expect it to be a decent-sized product given the fact that it's an ophthalmic product, and we already have relationships with some of the ophthalmic distributors.
Okay. And apart from this product, which are the other biosimilars in the pipeline and launch timelines for those?
So we are hoping that pegfilgrastim is going to be our first one. And we are waiting for FDA approval for the product and have the ability of launching it as well in the next, hopefully, in the next 12 months, subject to FDA approval and clearance of the Pune site. Ranibizumab would be the second one. Aflibercept also is progressing well in development, so building on the ophthalmic franchise. And then we have a couple of partnered products, denosumab in Japan with a partner. We don't have plans to bring it into the other markets unless we find a partner. And then etanercept in the U.S. in 2029. And then we have a couple of products that are earlier stage, especially the respiratory biologic like mepolizumab and vedolizumab, earlier stage in development.
Okay. So it appears that in each therapy area, there is one or two products. With this kind of portfolio, then will you have your own field force in the U.S., or will this be a partnered field force?
Yeah. So we have a cautious approach on biosimilars. We don't plan to really build a market presence for each therapy area. So we intend to partner where it makes sense. And if we have the ability to leverage our infrastructure, if there is a synergy with the rest of our business, then we will commercialize ourselves.
Okay. Sure. Okay. Thank you for taking my questions.
Yeah.
Thanks, Alok. We'll take the next question from Saion Mukherjee. Saion, you can get back.
Yeah. Thanks for the follow-up. Vinita, on NaMuscla and generic Fostair, what is the headroom to grow this business in Europe? And on NaMuscla, you mentioned about the new indication for U.S. and Europe. If you can talk about the timeline on that indication and what's the market size one can expect?
Yeah. So we are really excited about the potential of NaMuscla and the DM indication, DM1 and DM2. We have started the study already and also got FDA feedback on the DM study and believe that we should be in a position to file to the U.S. in 2026. So it will take us through next calendar year into 2026. But the potential we see is sizable. Both in Europe, the potential of the DM indication is multiple times the NDM. We think it could be a $100 million product in Europe. And then in the U.S., based on pricing, it can be well beyond that. So in Europe, likely we'll launch first. But the team is in the process of putting the plans together, especially with the addition of Klaus now, making sure we can leverage the opportunity across all the developed markets on a timely basis.
Okay. And so fiscal 2027 is what you're indicating as filing, and then in fiscal 2028, possible commercialization in the U.S. Is that a right understanding?
That's right.
Okay. And do you have for this new DM indication any clinical data with you which suggests the success of this product, or we have to wait and see for the phase III data to come before you kind of get the confidence of having this as a commercial success?
So right from the start, when we embarked on this product, we knew that the product works for NDM and DM. We know that clinicians have been using it off-label. And that's why we thought that it was a low-risk study to pursue. And likewise, for the DM indication also, we think while the data will have to prove it, obviously, and make it to the label for us to be able to commercialize it effectively, we have a high degree of confidence that the product works. There's nothing else available for the indication. So the physicians are very enthusiastic about seeing the product make it through clinical development to the market.
Okay. And any comment on generic Fostair as to how much more opportunity is there for Europe?
It's been a substantial growth driver for a European business and continues. As we look at the next fiscal year, Luforbec continues to be a major product for us in Europe. I mean, so far, we have got into some of the major markets. We have not entered Spain as of yet. So we have a presence across 11 countries at present, so continue to expand geographically as well in Europe over the next year or two.
In the U.K. or some of the big markets, can you share market share on the product?
Why don't we get back to you? I mean, we are.
Okay. No.
Yeah. We are still the market leader apart from the brand. And it's been a big growth driver for us in U.K. in particular.
Right. Ramesh, one question on the employee cost. We have seen around 15%-17% increase in the employee cost, which seems to be on a higher side. So if you can give some color as to why the level of increase is this high? Is there some new expansion that is driving it? If you can give more details on this.
There is, of course, this complement of people who have been added during the course of this year, this quarter, and there is, of course, another in terms of the ESOPs. There is the share price has been going up, and when we compensate people in terms of ESOPs, there is a charge to the P&L to that extent, and it is being brought in here. The third, of course, is the normal increments that you pay to people and stuff like that.
Understood. And just one last question, if I can ask on the tender business. So it seems for the last two quarters, this was at a higher level. So how should we think about the next two quarters and maybe even FY26?
By its very nature, it is always going to be sporadic, essentially, because there is some inconsistency. The overall business that you're competing with, that is about $650 million across the world, but the timing of that is always very difficult to kind of ascertain, for example, the tenders in India are delayed for a couple of years and the like, and then they got it. They brought the urgency along with, in fact, the Global Fund. From that perspective, it's something which we can't really predict, but it's a market which is about $650 million, and we obviously are very competitive in that market.
You might see some lumpiness, but I think we'll largely be at this level. I think it's going to be a good year for that business.
Okay. Okay. Thank you.
Thanks, Saion. We'll take the next question from Tushar Manudhane.
Am I audible?
Yes, you are.
So just on the GLP-1 opportunity, as far as emerging markets are concerned, in terms of the value chain, where is the key hurdle? Is it going to be the marketing, or is it going to be the manufacturing, from end-to-end manufacturing? If you could share your thoughts here.
I think in India, it's about the commercial excellence, so it is going to be about that, and that's the reason why we're not that hung up that we have to manufacture this or the like. I think, obviously, when we do this for developed markets, we are going to want to control more of the value chain, so obviously, manufacturing, even the R&D, all of that would be done as well, but I think where we have branded generic markets, there, I mean, it's more access to the product than anything else, which is important, and in other markets, we would obviously do a more holistic play.
Given the kind of business, which let's say the innovator companies are making on this product, despite that, the manufacturing won't be the constraint for the emerging market. Is that the right understanding?
Not for India, for example, right? I mean, I think the crown jewel and all of this is going to be the India conversation, and I think in India, it's going to be about commercial excellence.
Besides, we have looked at manufacturing capacity, and if we launched in every market that opens up in 2026, we are still able to manufacture internally if it came to that.
That's great. And secondly, on this dalbavancin, what would be the market size?
I don't have it off the top of my head.
We can get back to you.
Yeah.
Fair enough. That's it from me. Thank you.
Thank you, Tushar. We'll take one last question from Shyam Srinivasan. Shyam, are you there?
Yeah. Thank you. Thank you for taking my question. Just the first one on the trajectory for the U.S. business. It's been kind of range-bound with the exception of, say, Q1. So just want to understand how should we look at the second half?
I think, like we said, we should be able to increase closer to the 230+ , again, depending on the pressures that we see on some of the key products, but overall, inching up to over 230 and likely the second half enabling us to close at a double-digit growth level for the year, and as we get into next year, first quarter, we should have the impact of tolvaptan plus the injectable products that we hope to get approved by the end of this fiscal year, early next year, as well as others that we have on our plan, so we expect to get to that 250 level through the next year to be able to be at the $1 billion plus next year.
Understood. And would that, Vinita, entail a much better margin profile for us in terms of the U.S.? Or maybe what is the current U.S. margins closer to corporate average? Or you think once we reach the billion-dollar mark, it could now punch above that?
No, so it is already above that. And the newer, more complex products have enabled us to actually expand our margins. So we would expect that to continue given the pipeline that we're bringing to market, again, is limited competition products.
Understood. And my last question is just on the sales force productivity in the India business. I think 7,700-odd medical reps, right? So is there any PCPM number that you can share at this point of time, and where do you think this can likely reach?
Yeah. We didn't have it offhand. We're trying to pull it out. Otherwise, we'll share it with you. I mean, clearly, I think one part is we were underindexed. Therefore, we have added a substantial sales force in the last two years. Now it's going to be programmatic. So we're going to add a few hundred representatives each year. The focus definitely has to be on productivity. We have some very nice AI measures that we're putting in place. Hopefully, those would be interesting plays as well. We would want to focus on productivity as well in line with maybe a little bit of increase in areas where we are lesser represented.
In this, how many we added first half or second quarter also?
Marginal. Very, very not much at all. It's been continuously increasing over the last five quarters because initially, there's a training. There's a teething period when they're not as productive. If you look at the current quarter, it's close to about INR 7.5 lakhs per month. And this has been increasing. And it's still not reached the peak which we did about a year and a half ago. This week is, obviously, it takes time to kind of train the people and so on as well.
Yeah. Ramesh, what was that number, historical?
We were closer to this market about a year and a half ago.
Okay. Like nine, 10 lakhs, you're saying?
7, 7.5, 7.8.
Okay. Okay. Thank you. Thank you and all the best.
Thank you very much, Shyam. That brings us to the end of the Q&A session. I now hand the conference over to the management for their closing comments. Over to you, ma'am.
Thank you. Thank you. So thank you, everyone, for all your questions. Just wanted to respond to the glucagon question. What we have is the kit. And we look at it as a nice size opportunity. It's roughly a $200 million product where we hope to be one of maybe two players in the market. So looking forward to that. And as I mentioned, I mean, we are very optimistic about our growth prospects. I mean, both this fiscal year as well as the years ahead. We know that we have still a long way to go.
Although we have come a long way as an organization, when you look at our growth trajectory as well as our margin expansion, we continue to be focused on driving both growth across our key markets, not only U.S. and India, but also the other developed markets that we can now grow with complex generic platforms or specialty and other emerging markets based on India portfolio and, in particular, the GLP-1 opportunity that we see in front of us. So looking forward to a very successful rest of the fiscal year. And we'll look forward to connecting with you again soon. We've noted down a number of questions that you had that we had agreed to get back to you offline. So we will connect with you to respond to those. Thank you again for your time. And look forward to connecting with you next quarter.
Thank you so much, ma'am. On behalf of Lupin Limited, that concludes this conference. Thank you for joining us. And you may now exit the webinar. Thank you.