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 note that this conference is being recorded. I now hand the conference over to the management. Thank you, and over to you, ma'am.
Good evening, everyone. I'm very pleased to welcome all of you to our Q3 earnings call. I have with me our MD, Nilesh, our CFO, Ramesh, and our Head of IR, Ravi. We look forward to sharing our Q3 highlights and outlook for the fiscal year. We're very pleased to have delivered another quarter of strong performance, continuing to build on the momentum over the last many quarters. We delivered our highest quarterly sales so far, crossing the INR 5,000 crore mark. What is very heartening is that all our major regions have performed. Not only have we seen revenues grow across our key segments, but we also achieved higher profitability, both at the gross and operating level. Our US business delivered a second consecutive quarter of $200+ million dollar revenues and a sixth straight quarter of EBITDA improvement, which is very heartening.
This has been aided by volume-led growth in our base business, augmented by contribution from seasonal products and our respiratory portfolio, including tiotropium. As mentioned in our earlier interaction, we expect to sustain our U.S. business at the $200+ million levels in the next few quarters as we get into the next year, with a continued ramp-up of tiotropium and launch of new products, including multiple ophthalmic and complex injectable range. Our India business recorded strong double-digit growth this quarter, with a 1.6x IPM growth rate. Most of our therapeutic areas like respiratory, GI, gynecology, have outperformed IPM during the quarter. We have launched around 21 products in the year so far, and per IQVIA, we are ranked number one in new product launches in India.
We have a strong chronic focus, as you know, with more than 60% of our sales contribution from chronic therapies. We believe that we are in a very good position now to deliver above market growth, consistently going ahead, led by higher productivity from our sales force expansion, new divisions and enhanced penetration and reach. Apart from the U.S. and India, other regions have performed very well, too. Ex-U.S. and India, our formulations business has grown 30% year-over-year during the quarter, and 22% in the nine months during the fiscal. The strong growth recorded in key markets like Canada, Philippines, Australia, and South Africa, and also a very strong ramp-up of generic Foster in our direct markets, you know, U.K., Germany, as well as, through partners in the rest of Europe. Switching to R&D.
On the pipeline front, we have continued to build momentum with both material first to files and complex generics. We received 14 ANDA approvals during this quarter, including key product approvals like generic tolvaptan and ganirelix, which is our first peptide injectable product. We also launched brimonidine ophthalmic solution, the generic version of Prolensa, thanks to our Pithampur Unit Two facility approval, and, as you know, we have 6-month exclusivity on this product. Out of Somerset, we launched diazepam rectal gel, which has also been an extremely nice launch for us. In terms of key filings, in the last quarter we filed Risperdal Consta product out of Nanomi, which is a significant, you know, validation of the platform as well as strong, complex injectable product filing for us.
So as I mentioned before, our R&D is evolving to more complex products, especially on the inhalation and complex injectable front, which augurs well for the sustainable growth of our business going ahead. Compliance is our number one priority, and we are fully committed to ensure that all our sites are fully compliant with FDA and other regulatory agencies around the world that we serve. We have completed remediation efforts at Tarapur and Mandideep, as Unit One, and are confident that we will get these sites, cleared, as we've done with the others in, the near future. We are delighted to have delivered on our promise of sustained and profitable growth during this year. We feel confident that our strategic focus on R&D, patient centricity on the brand front, and continued cost business optimization sets us on a path of sustainable growth going forward.
With this, I will hand it over to Ramesh for a deeper analysis of our performance.
Thank you, Vinita. Friends, I welcome you all to our Q3 FY 2024 Earnings Call. I'm happy to report that this quarter we have delivered the highest top-line number in our history, and after many quarters, for the first time, we have surpassed the 20%+ mark on the EBITDA front as well. Diving into the numbers, sales. Sales for Q3 FY 2024 came in at INR 5,080 crores, as compared to INR 4,245 crores in Q3 last year, a growth of 19.7% year-on-year. On a quarter-on-quarter basis, the company reported growth of 2.8% as compared to Q2 of FY 2024. We have registered robust growth across most of our key geographies. North America has grown at a strong 24% year-on-year. During the quarter, the U.S. dollars staying steady at Q2 levels in constant currency.
This has been due to volume share increase in base products. Inhalation products this quarter is around 40% of US sales. Coming to India, the India business has grown 13.4% year-on-year. The prescription business has grown 12.9% year-on-year during the quarter, and 10% during nine months FY 2024, handsomely outperforming the IPM growth during the period. Also, if we exclude the impact of the in-licensed products, our diabetes portfolio has grown at 2x the TA growth during the quarter. The share of in-licensed products to date has been reduced to 10.4% of our portfolio from around 15%-16% last year, and this has a positive impact on our profitability.
Our India region, which constitutes our EU region and South Africa business, continues its outperformance during this quarter as well, with strong growth of 36% year-on-year. Growth in EU has been driven by partner business and our inhalation business going strong. Our South African business has also grown a strong 21% in local currency year-on-year. The other income has increased by 51.4% this quarter, and this is essentially coming in from enhanced PLI benefits. Gross margins. Coming to profitability, Q3 FY 2024 gross margins were 66%, up from 59.8% in Q3 last year and 65.5% in Q2. This improvement was driven by multiple factors, which includes product mix, lower share of in-licensed products, and increased volumes.
At INR 1,560 crores, which translates to approximately 30.7% of sales, as compared to 31.5% in Q3 last year. On an absolute basis, costs have remained flat quarter-on-quarter. While there has been a marginal reduction in the R&D expenses on account of facing the higher volume demand at a higher manufacturing cost over there this quarter. R&D is INR 357 crores, which is about 7% of the sales in Q3 FY 2024, as compared to INR 290 crores at 6.8% in Q3 FY 2023. For the full year, however, we expect it to be in the region of INR 1,500 crores-INR 1,550 crores. EBITDA. In the quarter, as you would see, we have made improvements across all lines. Our gross margins are higher.
There has been an increase in the operating income, and the higher sales ensured higher operating leverage as well. Subsequently, this has resulted in driving the EBITDA margins considerably higher. Excluding Forex and other income, EBITDA was INR 1,022 crore, up by 98% year-on-year. Margins for the quarter were significantly higher at 20.1%, versus 18.7% in Q2 FY 2024 and 12.2% in Q3 FY 2023. For the nine-month period, the EBITDA margins excluding NCE income are at 17.8%. In so far as the tax is concerned, our ETR was 15.8% in Q3 and 18.6% for the nine months FY 2024. For the full year, we expect it to be around 20%. Moving on to the balance sheet.
Operating working capital as at 30 December translates to 96 days of net working capital. This is reduced from 135 days as at 30 December 2022. Our net debt stands at INR 1,042 crore, 43 crores, which has been reduced from INR 2,527 crores at the end. Our DJSI index scores have been reassessed pretty recently, resulting in an overall score of 69 for Lupin in the S&P ESG Assessment 2023. This increase from our initial communication underlines our continued effort to excel in sustainable performance, positioning us above the global average. Our latest Carbon Disclosure Project scores are in, and they speak volumes about the progress we have made in our sustainability journey.
Over the last two years, our diligent efforts and collective commitment have elevated our climate change disclosure from C to B in the Carbon Disclosure Project. This surpasses both the Asia regional average and the biotech pharma sector average, reflecting steady determination to mitigate climate risk and embrace sustainable practices across all our operations. With this, may I open the floor for discussions?
Thank you, very much so for the update. 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. Thank you. Thank you very much for the patience. So we'll take the first question from Kunal Dhamesha . Kunal Jain.
Hi, thank you for the opportunity, and congratulations on the good set of numbers. First, on the tiotropium, if you can share some of the trends in terms of, you know, prescription share that we have been able to gather till now, and where do you see we be reaching, let's say, in a fair amount of time, that would be great.
No, we can't hear you, so should we move on? We'll come back to you.
Hello?
Yeah. Now we can hear you.
Can you hear us?
No, please just come.
Kunal, can you repeat your question?
Hello, Kunal, are you there?
Yeah. Next question.
Okay, we'll move on to... I will take the question from Neha. Neha, you're in, please. Neha Manpuria.
Yeah, thanks for taking my question. Vinita, on the U.S. business, I know you mentioned there was some amount of seasonal impact, you know, in the quarter. Was it meaningful enough to have offset the channel inventory that we had in Spiriva?
Actually, you know, so there was some impact of the seasonal products, but also the baseline products have been very strong in the quarter. So products like lisinopril, sertraline a nd the like, have also performed pretty well. So, the baseline improvement, plus, you know, couple of $2 million-dollar impact of seasonal products, helped to offset, you know, the tiotropium channel impact. And, you know, even tiotropium, just from a s cripts perspective, is ramping up extremely nicely. So that gives us really good confidence of growing units and revenues over the next few months, you know, alongside the prescriptions.
You know, Spiriva, if I were, generic Spiriva, if I were to look at a market share in IQVIA, we are already close to the, you know, 31% number. You know, correct me if that number is off for you. And we'd, we indicated, you know, getting to 35%-40% share, sometime next year. You know, given how well we have done in the last two quarters, do you think, you know, that's an achievable number, or we can do higher than that?
I mean, I think, you know, we will still target that 40% level. You know, just given the strong, you know, ramp rate in the last couple of months, I'd say we'll be more at the 40% plus level, as opposed to the 35. So it's, yeah, turning out to really do extremely well.
Understood. Sorry, sorry to cut you, Vinita. Go ahead.
No, in terms of substitution, I was saying.
Okay.
Hard to see.
Currently, nothing on the AG, right? Any visibility there or anything that we have heard, your sense?
Nothing that we have seen so far.
Understood. And on the launch pipeline for FY 2025, now that you have, you know, 200+ to 15 sort of, you know, a $1 million base h ow should I look at the build for the U.S. business? You know, erosion will be what it is, but you'll have a couple of products which see erosion. So how should we think about the build from this level over the next year, next two years, probably?
So we have a good number of products next year, so 10+ products. You know, good six injectables, you know, with a couple of meaningful products like glucagon, fosphenytoin, that we intend to launch. And then on the ophthalmic front, we have some really good launches, xarelenza, which is gonna ramp up, as well as you know, we have loteprednol and a couple of other ophthalmic products, around 4 or 5 ophthalmic products. And then potentially a couple of oral solid upsides, depending on patent litigation outcome. Mirabegron and two material opportunities that we should get good amount of clarity you know about in the next couple of months.
But, even without that, I would say that, given the tiotropium ramp up, plus these new product launches, plus, you know, they will more than offset some of the erosion that we're likely to see in the oral solids. You know, including erosion in products like Suprep. So we very much expect the business to grow in the next year.
You know, to maybe a single-digit growth rate. You know, and if we are, if we get some of these patent litigation products out successfully, hopefully double-digit. And then as we look at the year next, we have significant products there with, you know, tolvaptan as a material product launch early in fiscal year 2026. The other injectable products, you know, liraglutide, as well as others that come to market. So, now, very confident of double-digit growth into fiscal year 2026. Hopefully, we can get from single-digit to double-digit also in fiscal year 2025.
Got it. Thanks so much, Vinita.
Thank you.
Thanks, Neha. We take the next question from Amey Chalke. Amey, are you there? Amey?
Hello. Thank you so much for taking my question. The first question I have is on Spiriva. If we can give some clarity on the Alvogen filing and possible launch, is it really a near-term launch as per your expectation, or you think that it will be post FY 2027? And the second question I have is on Dulera. If you can give us clarity on the Q, the CRL, which we have received, and possible launch for that product as well. Thank you so much.
Yes, so we definitely feel on Spiriva that we are in a very strong position.
Ma'am, the voice is breaking. I mean, we're losing. I mean, I think there's some Wi-Fi issue or something here.
Have you filed, which, we believe-
Yes.
protects, you know, the market for us. So we feel pretty good about, you know, the potential of, you know, being alone in the market over the next couple of years. You know, and if you just look at what it took for us to get approval, you know, of the product, it was 5 years at the FDA, and that was, you know, because the product is a pretty challenging product. So we feel pretty good about, you know, the next couple of years, hopefully building Spiriva to a very good level.
On Dulera, I mean, we've had an extremely good meeting with the agency back in November, and that gives us confidence that the response that we are putting together is gonna meet the agency's requirements. So in the next, you know, three months or so, we are planning to get the response together to the agency.
Sure. Thank you so much, ma'am.
Thank you.
Thanks, Amay. We'll take the next question from Shyam Srinivasan.
Hi. Good evening, and thank you for taking my question. Just the first one is on the trajectory of the US, right? So I know there's some channel filling last quarter, but we have seen market share gains in Spiriva, for example. So just want to understand, you know, is it because of channel filling that the QOQ momentum seems to be slow, and as we progress, this should kind of start inching up? How should I look at that dynamic?
Yeah. Sure. We should certainly see an increase in both the unit sales as well as--
Hello? Sorry, I think the audio keeps going away. Operator, maybe-
Can you hear us?
Yeah, we can hear now.
Now we can hear you. Yeah.
Now we can hear you, but, Vinita, we couldn't hear you in parts. If you could repeat. Sorry.
Oh, my apologies. What I was saying was, we certainly expect, you know, as the channel inventory is normalizing, our revenues, units revenues to grow in line with our prescriptions in the months and quarters to come.
Yeah. And again, sorry about this, but the opening remarks again, when you give the guidance for the new base, if you could again repeat that. I'm sorry, but it's parts of your conversation just went away. Sorry.
Can you just give us, can we just pause for two minutes just to-
Yeah, sure, sure. I'll be here. Yeah.
Sean, do you want to switch your volume, please?
Yeah. If I don't get a chance again.
Just switch it off.
Is this any better?
Vinita, I can hear you. This is Shyam. Yeah.
Okay, so this is, this is good?
Yeah, this seems, but operator, maybe you can confirm. Sorry.
Oh, okay. Apologies. I didn't know... We didn't know that you could hear us. What I mentioned was that, you know, having now delivered two consecutive quarters of $200 million plus, we are confident of continuing to deliver, you know, at that $200 million-plus mark in the quarters to come. And I also said that, in the next year we should grow our U.S. business, you know, single- digit percentage, but hopefully more if we have a couple of the key litigation products pan out. So and then-
Yeah.
That, that's what we had guided.
Got it. Thank you. There are a few clarifications. In the presentation talks about you will maintain share on the base business. So have you seen, you know, any levels of price erosion that you can guide on the oral solid side of things?
It's been a very low single-digit price erosion on the oral solids, for in the quarter for us, you know, offset by volume growth.
And Vinita, this prognosis for the future, like 2024, let's assume calendar year, any dynamics around supply chain or buyer groups, is it changing, even shortages?
Yeah. So drug shortages have been really strong over the last couple of months and quarters, and that continues to be the theme as. You know, so that has really helped normalize price erosion to the low single digit level. Again, we expect that in the oral solids, we'll probably see a little more in term price erosion versus areas like inhalation and injectables.
Got it. Helpful. Just my second part of the question is on the India business. We have now done better, right? And I, remember our guidance earlier was for like in 2025, but looks like Q3 we have done better. So is this a one-off, or do you think some of the declines that have come because of the license portfolio is behind us? So just some path around even the near-term India growth and maybe a reiteration of the, like, a fiscal 2025 or beyond, what, our growth levels could be.
Sure. I think, so Q3 has been a bit of a catch-up. But if you really see on a 9-month basis, we're staying within that 20%-30% ahead of market growth, which we would expect to continue. That's what I see for the foreseeable future, and it's driven by our key therapy areas. Obviously, we grow faster in some. So respiratory, for example, we're growing at 2, anywhere from 2- 3x the market growth rate. But in diabetes, where we had the licensed portfolio, you know, we're still growing at a single digit kind of number, although we're growing a bit ahead of the market now. But I think short answer, we'll stay at the 20%-30% ahead of the market growth rate.
We do expect the market to stay at high single digits, so, you know, hopefully we'll keep this at double-digit growth rate for the future.
Nilesh, anything in terms of our distribution? Are we now a field force, if you could just refresh some of the numbers around our distribution, and is there any plans to increase it? Thank you.
Sure, sure. So I think the entire India agency was close to 10,000 people now, about 8,000 plus in the field itself. About 32 divisions at this point of time. We launched 6 or 7 divisions in the last 9 months. And we will launch a couple more divisions in the next 2 quarters. But I think we're pretty well set now. I think, you know, the part which I'm really excited with is our extra urban division that we launched last. That's where we'll be adding sales force in the months to come. You know, I think the idea is to make, you know, bigger brands. You know, we're doing that in respiratory, we're doing that in cardiovascular and diabetes as well.
But there's also this opportunity to focus on extra urban. So, yeah, we are doubling down on India. The new product line, pipeline is also shaping up very nicely for India. So, you know, we had 21 launches in the last 9 months. We were number one in new launches in the last 12 months. But I think the focus on launches for India is gonna remain. Some very nice launches in respiratory, some of them first to, first in the world as well. But that will continue, and I think we're still- we've not even got into new modalities or, you know, biosimilars and the like, so, so a lot more, a lot more to come for India.
Got it. Thank you and all the best.
Thank you, Shyam. Before we proceed, there's a sincere request to limit your questions to two or three per person. If there are more, you can always get back in the queue, and we'll surely take it if time permits. Next question is from Damayanti Kerai .
Hi. I hope I'm audible.
Yes.
Okay. Thank you. My question is on your EBITDA margin trajectory. You know, remarkable improvement, which we have seen in last few quarters. So how should we look EBITDA moving from here on? And if you can also elaborate, but, like, where do you see, like, significant headroom for improvement in terms of cost or digitalizing, et cetera? So that's my first question.
You know, from my perspective, the pivoting to, you know, to a complex, like, complex generics has really helped. And it's fairly sticky, as you would recognize in America and in Europe and the like, and there has been secular growth in other markets as well. But we would also recognize that whilst there's a lot of room for optimism, you know, there are certain, you know, dark clouds on the horizon also, in terms of the Red Sea, you know, disturbances, air freight, going up and the like as well. So several moving parts. So having said all of that, the fact of the matter is, you know, our EBITDA margins are still lower than the, you know, the competition, and we would like to get to the 22.5-23% range.
But given all of this, you know, the moving parts, we would like to be, you know, we'd like to state that it should be between 19.5%-20.5%. But clearly, the pathway is to get to the 22%-23% as early as possible.
Okay, this 23% kind of margin, that should be over, what? 3-4 years from now? What is your target in mind, very broadly?
Earlier than that, hopefully. Much earlier than that.
Okay, and you mentioned about this Red Sea situation. Are you seeing, like, impact of the geopolitical issue in your freight cost in, like, current month or so?
Yes, it is. It's actually gone up by a good 30%-35% already.
Okay. If it doesn't, say, we don't see any improvement there, then the impact should be majorly reflected in the March quarter numbers or maybe beyond that?
In some ways, it gets inventorized, because what we move out here would potentially go into, you know, the cost, which will get built and will be there in the balance sheet, but will certainly hit us in the quarters to come, at least in the first year, in the next fiscal, yeah.
Okay, understood. Okay, my second question is, you talked about, like, you're focusing a lot on complex products, et cetera. Can you talk a bit whether you are working on these GLP anti-obesity products and how far these products are from launch from your perspective, if any?
Yeah, so the GLP-1 products, you know, you have the earlier products, the Victoza, Saxenda, liraglutide products that we've already filed and should come to market, you know, in 2025, 2026 timeframe. And then there's semaglutide that I think is in 2028, 2029 timeframe. And the latest products that you see, like Mounjaro, you know, they are , of course, out. Can you still hear us?
Yes.
We can, we can, ma'am.
Okay. We just wanted to make sure. Yeah. You know, so the latest products, like Mounjaro and Ozempic, are out a little bit further. So all of them are part of our pipeline and portfolio. You know, being material products and injectables in particular. So you know, over the next few years, we'll start seeing some of these generic versions come to market.
Sure, ma'am. Thank you. Thank you for your response.
Thank you very much. The next question is from Kunal Dhamesh.
Hi, can you hear me this time?
Yes.
Yes, we can.
Yeah. Thank you for the opportunity, and congratulations on a good set of numbers. First one is on the India business. While you have given good clarity on the in-license portfolio, which is currently at around 10% of revenue, let's say in the next couple of years, do we see any part of this portfolio having, again, losing patent expiries or, you know, any issues? And if yes, you know, what proportion of this 10% is at risk?
Yeah. So by the end of FY 2025, we see a couple more products going off patent. We'll still grow. In the diabetes space, we'll still grow, but we will see that coming off. But, you know, we're down to just 10%-11%. Our hope is to also create more in-licensing deals, which will, you know, likely increase this number. You know, I think this is almost an all-time low for us at this point of time, and that is driven by the exclusivities that went off and the products that went off as well. We've obviously supplemented that with our own portfolio, including generic versions of some of those products as well. But, you know, I think there will be a little bit more decline in the diabetes space.
Hopefully we'll make that up with some of the other therapy areas.
Sure. Sure. Can you give the percentage of the brands that are going off patent? What is the percentage revenue right now?
I don't have it offhand, but it's, you know, that 10% will go down by 1% or 2%, if at all.
Okay. Sure, sure. And second question, second question is on tiotropium. With our launch of HandiHaler, have we seen any market share shift or units shifting back from the newer version to the older version because of the generic availability, or that has not been the case?
No, so it's too early to tell, you know, because it's just really been a few months after the launch in August. But I'd say that the share has kind of stabilized, you know, HandiHaler with the brand as well as our product at that 40%-45% level, and Respimat at that 60% level.
Sure. And, what would be our gross debt currently?
Gross debt.
Gross debt. Well, the net debt is INR 1,000-odd crores, so essentially, gross debt really doesn't matter so much.
Okay. And when. Yeah, when you said that 20%-23% EBITDA margin, you know, if everything goes well, does that bake in the some of the litigation product that we talked about?
Well, you know, so essentially it will come in the MTP period anyway, if not next year itself. Your first question on the gross debt, it's INR 2,600 crore.
22,600--
INR 2,600 crore, I said.
Two thousand--
2,600. Oh, 2,600.
Yeah.
Okay. Yeah. And then on the EBITDA margin, this 22%-23% assumes some of those litigated products. How should we think about it?
Yeah, it includes a pipeline that, you know, includes products that are date certain launch as well as litigation.
I think in general, like Malika said, I think on, you know, from generics to get that single digit or double-digit growth rate, you know, markets like India are growing at either high single- digit or double-digit numbers. So there's gonna be this growth momentum, and then there's obviously operational efficiencies and operating leverage that we would expect all of this to together contribute to the number that Ramesh talked about.
Sure. Thank you.
You know, on the cost front, there's never going to be a switch on, switch off situations. You know, so essentially, for example, if you're talking about addressing idle time, you know, looking at, in fact, the things like footprint and all of that, it takes time, right? So that's the reason why we are giving us this slack period.
So I think at some point we had this INR 500 crore cost reduction plan, right? If I remember it correctly. If you can provide, you know, if there is any update, you know, some part we have achieved, and what more can be done.
Yeah, achieved quite a bit on that, you know, so but obviously it gets camouflaged in terms of, you know, rising where, wherever we invest ahead of the curve, as in the case of, you know, sales and promotional expenses across various parts and the like. But to be sure, there are, you know, still some inefficiencies that we believe that we can bring down, which could include things like, for example, inventory write-offs. There are some FTS, there is something on the idle time, and the like. We're still airfreighting some products and so on, you know, it really is based on demand. So from that perspective, we would like to cut all of that. It's always going to be an approaching target in that sense.
Just a bit.
Sure, sure. Thank you, and all the best.
We're hearing some disturbance on the line. Can you hear us?
Yeah, we can hear you, ma'am. It is, I think it's the background when Kunal was speaking.
Okay.
Yeah. Thank you. So we'll. Thanks, Kunal. We'll take the next question from Bino Pathiparampil .
Hi, can you hear me?
Yes.
Yeah, Bino.
Okay, good morning, and good evening. Couple of questions on products. Vinita, do you still expect pegfilgrastim to come in FY 2025?
Yeah, pegfilgrastim. We have a CRL that we have just received that we are planning to respond to in the next three months. So we should get approved in,
It will be end of FY 25 or just after.
Right.
Okay, understood. Second, on your glucagon product, could you give an idea of the addressable market and, what's the competitive scenario like?
I know that it is a high value, low competition market. I don't have the exact competitive landscape there, but maybe, Vinu, we can take that offline. Ramesh can connect with you offline. Yeah?
That'll be enough.
Sure, that'd be great. And, recently, you had this approval of dronedarone. Is that going to be significant, and what are the timelines like?
Dronedarone also, we will maybe get back to you. I mean, when we look at the next two years, I mean, the major products for us, as I mentioned, are you know, injectables that we've already filed, that we are well, well on our way for approvals. Ophthalmic, you know, products like glucagon, fosphenytoin, as well as, prednisolone, loteprednol, like ophthalmic products. And then, you know, in the fiscal year 2026, as I'd mentioned, products like tolvaptan, and you know, like liraglutide products will be material products that year for us, as well as, Risperdal Consta that we have now filed this past quarter. We hope that in fiscal year 2026, we're able to get it to market.
Okay. And one last, if I may push in. In mirabegron, you said, you know, you're waiting a litigation outcome possibly in the next couple of months. In case the outcome is favorable, when could we see the product? And in case the outcome is not favorable to you, then what happens? Does it get pushed out by some time, or does the opportunity go away?
No, it doesn't go away, for sure, based on the patent scenario. I mean, if you know, I'd say that Q1 fiscal year 2025 could be a really good timeline to launch the product. And, you know, and if not, we'll have to really, based on the litigation outcome, we'd have to determine what is the potential launch date.
Got it. Thank you. Thank you very much.
Thank you.
Thanks. Thanks, Vinu. We'll take the next question from Surya Patra.
Yeah. Thank you. Thanks for this opportunity, and, congrats on the great set of numbers, ma'am. My first question is, this inhalation portfolio. You, for the U.S. business--
Yeah, tell me.
Can you hear me? Hello?
Hello?
Yes, we can hear you.
We can hear you.
There's some background noise, sound of someone in the background. Surya, do you want to join again, maybe?
Surya, do you want to join back again after some time?
We can start with Krishnendu.
Yeah, yeah. We'll take the next question from Krishnendu Saha.
Yeah, hi. Thanks for taking my questions. Can you hear me?
Yes, we can.
Yes.
Yeah, just quickly, last time we respiratory, as a percentage of revenue, was around 45%. This time, I heard Ramesh speak about 40%, though the absolute number is $213 million-$209 million. What, like-- so just wondering what happened out there, like, nothing major, but just want to get a directional feeling. Yeah.
So we couldn't hear part of your question. Your question was muffled.
Yeah. Last time, when in the last quarter, we spoke about respiratory being 45% of the U.S. revenue.
Yeah.
Now we speak about being 40%. So I was just wondering what the difference could be. Is it because of Brovana's fallen off the cliff, or just, because still we have a large share of Brovana? That's also, that's the first question. Second question is, we have a large tentative approval for Xarelto, the blood thinner, I suppose. It's a pretty-- it's a tentative approval. So is there anything much to it? It's according to the press release, it's $8.5, $8.3 billion market. So is there anything to read into that?
So on the respiratory side, there's nothing that has fallen off. I mean, the major difference, you know, the 45% to the 40%+ level is primarily the tiotropium loading into the channel, you know, for-
I see. I see.
In Q2 versus Q3.
I see.
Some seasonality impact in albuterol because, you know, some of our customers bought ahead of the season to be prepared.
I see.
But otherwise, very stable in terms of share, Albuterol as well.
I see.
So, you know, a really, you know, pretty strong foundation there on the respiratory side of the business. And, Xarelto, you know, I don't see it as a product launch in the next two years, but certainly is the fact that we have a TA. You know, perhaps we can get back to you in terms of the potential launch date.
Sure.
Yeah.
Sure. And, just sorry, I'm a little bit sketchy about all the data bits and a lot of pharma hardcore. So Spiriva, just if you can directly tell me, do you expect competition in the next two years, or what is your thought process? And just on the margin front, the steadiness in the margin is partly, is it because of product mix or the combination of product mix and the cost initiative which has kicked in? And also, sorry, the last question again. So we had an increase in MR last year from 7,000- 9,000. Has there been optimized in your manner, or do you think the PCPM could improve from here onwards? Sorry, too many questions. I know two, but you can help me. Thank you.
Yeah. Your first question was on Spiriva, right?
Yeah, best guess. But, yeah, best guess. What do you think?
In terms of competition?
Yeah.
We believe that till 2027, you know, the key pattern that one has to get around in 2027--
Sure.
There are good number of hurdles for competitors to get in. There's also our patents, Lupin patents, that-
I see.
Everyone will have to get around.
I see.
That gives us the confidence of, you know, no additional generic competition over the next couple of years.
I see.
What was your second question?
Second, field force.
I can hear you.
Field force and in the field force increase, has the efficiency been factored in? And the improvement in margin, is it a combination of product mix and a little bit of cost improvement, or there's a lot of cost improvement still to be done?
So I think obviously these reps have been added only in the last year, so we are, you know, seeing them improve. And, you know, every-- all of them have been, you know, almost all the divisions have been performing as per expectation, but you would expect the per capita to keep improving. So we will definitely see more leverage coming out in that we've added. We're gonna add a few more people, but obviously had a bit of a big bang catch-up kind of increase, which happened. With that, you know, obviously, the mix with improving as well, and I think that's what you're seeing reflected in the overall gross margin.
Any target PC?
It varies per division, right? For example, we've launched the Extra-Urban. We would never expect it to get to a cardiac kind of level, where I think, you know, I think we're usually in the top two or three in PC across therapies.
Thanks. Sure. Thank you. I'll come back in the queue. I've got another question down the list.
Thanks, Krishnendu. Since we still have a few minutes to go, we'll leave the floor open to take a couple of more questions. Please, raise your hands from the participants tab. We'll wait for 10 seconds for any further questions. Okay, the next question is from Harith.
Hi, hope I'm audible. Thanks for the opportunity. So, I'm trying to understand our inhaler pipeline beyond Spiriva and Dulera. So, are there any inhaler products that are in phase III trials currently, which can get into a stage of filing in the next 12 months or 18 months?
Yeah, so we have a few products that are pretty far along in development. I mean, we have Dulera, one that's already filed, where we have a CRL response that we, we're gonna be filing based on the feedback that we got from the agency. So that, of course, is one. And we have, you know, the Respimat products actively in development as well as the Ellipta products pretty far along. You know, and they are in the next 12 months, you know, at least one, if not two, of the products on the two platforms, we should be taking exhibit batches, potentially filing.
Okay. Ma'am, this product, Xopenex HFA, which we had acquired from Sunovion--
Yeah.
Over 12 months back, how has the ramp up been for that product? When we acquired, the Rx was not very material. How does it look now?
It's actually grown. It's was a very stable product, and it has grown without any promotional effort over the last 12 months. So at this point in time, we are actually looking at you know, potential avenues to put some effort behind it, to grow it even more. So it's been very nice addition to our portfolio.
In terms of generic competition there, what is our expectation?
We don't think that, you know, it is not a large product to really justify clinical development. And so we think that the product should remain exclusive. And also, we have plans with the product in terms of life cycle management to really do 505(b)(2)s on the inhalation front that we are working on. So hopefully, we are able to, in the next 12-18 months, make progress on that front as well.
Okay. Last one, with your permission, on generic Suprep. We saw a couple of generic approvals, towards the end of Q3.
Yes.
Trying to understand if the contribution for us from generic Suprep in 3Q was as significant as it was in the second quarter, or was there a sharp decline?
There was a decline of, you know, between Q2 and Q3, on Suprep. And we expect, you know, although it wasn't very sharp, because the competition did not really come in in the last quarter, you know. It's really gonna be this quarter where we start seeing competition on Suprep.
All right. Got it. That's all from my side. Thanks for taking my questions.
Thanks, Harith. The next question is from Saion Mukherjee.
Yeah, hi. Thanks for taking my question. Ramesh, if you can, you know, like, we have got to 20% EBITDA margin. So if you can, you know, sketch in terms of markets, which are the ones where you see the margins, you know, much higher than 20%, and which are the ones which are sort of lagging behind? And how the dynamics on margins for each of the markets, for the key markets, if you can highlight.
I guess the only market where the things are lagging, is this before taking into account corporate expenses. If you take corporate expenses, obviously things could be a little different. But I think, Latin America is one, where it has been lower, at least in recent times. Mexico, more because of, certain issues on the factory front, and whilst Brazil, of course, has got some issues on the business front itself, and we are working on that. And then more importantly, I think, one also has to recognize that we have in fact a host of adjacencies that we created in the recent past. If I were to knock that out today, my margins would be a good 2.7% higher, you know?
So while I say it's 20.1, and so on, we need to actually add about 2.5 percentage points for in fact, the adjacencies that we created, which includes your digital, your diagnostics, in some way, you know, your, the OTC business and the like as well. And all of this actually have, they have a pathway for actually kind of, not monetizing it, I would say, but actually saying that allowing it to kind of, raise their own resources and spinning on their own axis. And once that happens, you would expect those margins to, and the overall core margins to go up by at least 2.5-3 percentage points. So, that's where we are today.
I think it's basically a, you know, a combination of, in fact, the newer businesses that we started and, you know, the conventional business are still, you know , Mexico is just, you know, it's a year-and-a-half story, while of course, Brazil is a little more medium term.
Perhaps just to add to that, I'd say that the India region, which has grown very nicely, is still in the investment mode, so it's not at that 20%+ level as of yet, but it'll get. It's getting there with operating leverage and, you know, our portfolio. So tremendous potential there as we look at the next couple of years.
Okay. Any comment on the API business? Because, you know, it's small, but you know, it has been a big drag, at least in the recent past, I understand.
Yeah. So yeah, we were almost flat in the quarter, right? It was slightly declined. So I think, you know, there's products which have scaled up nicely, and others which are still continuing to be challenging. I think the Pen G situation continues to have some challenges, and therefore products like Cephalexin and Cefadroxil will remain impacted. Products like Cefaclor remain impacted as well. We do see growth in the next year, so you will see a bump up in the API business, but I think it has to be driven more from our perspective with some of the stuff that we do in LMS, Lupin Manufacturing Solutions , in terms of new products and building that book of business.
You know, bringing more new launches, because we're still primarily working off our old portfolio at this point of time in the API business.
Understood. Vinita, I just missed, you mentioned, you know, in your comment on the inhalation filing, you mentioned on, like, Respimat or Ellipta, one or two of these products will get filed over the next 12 months. Is that what you mentioned?
Yeah, they should be in exhibit batch.
Okay.
Potentially filing by--
Okay. Okay, thank you. Yeah, thank you. Yeah.
Thanks, Saion. We'll take the next question from Nikhil Mathur.
Yeah. I hope I'm audible.
Yes.
Yes.
Yeah. Sorry if there's some background noise. I have two questions. The first question is on the margin trajectory over the next 2-3 years. While you are guiding to a glide path of 20%-23% EBITDA margin at some point in time, what kind of generic cycle are you building in, and when you're trying to achieve these margins? I would imagine that there is some support from below trend generic pricing erosion currently. But we have seen in the past, this tends to be pretty cyclical. We don't know, I mean, maybe in FY 2026, there's a big down cycle again.
When you are expecting margins to improve going forward over the next 2-3 years, what kind of generic cycle are you building into your base case assumptions?
I assume on the generic price erosion, that's what you're asking about, right?
Yeah, I mean , if there's a big down cycle again, let's say 12 months down the line or 15 months down the line, then is... Would a 20%-23% EBITDA margin be a far-fetched thing to kind of achieve?
I would say that, you know, given our mix has evolved to more complex generics, you know, 40-45% inhalation. Next year, adding injectables, where one does not see this kind of price erosion, gives us the confidence one that we have a growth segment pipeline that helps us grow the margins. Second, I'd say that the oral solids, which have gone through a lot of price pressures over the last couple of years and stabilized over the last 12 months, one has to realize that companies got out of the market, therefore, you saw drug shortages.
There's some background noise.
Sorry?
There is background noise.
No, sorry, there's, there's some background noise at my end. I'm so sorry about that.
Yeah, so, as you know, the oral solids also, there's a lot more awareness now that, you know, putting pressures on manufacturers will, you know, will cause exits, more product exits, like we did in the past couple of years. So we do think that, things are, somewhat better for the oral solids, although not as good as the complex, portfolio. So combination of that gives us the confidence that we should, continue to improve the margins.
You know, like our U.S. business, I mentioned six consistent quarters of improving margins, and that was a combination of both, you know, our business upsized product portfolio mix towards complex generics, plus efficiency measures, on, you know, the logistics costs, you know, returns, freight, as well as, you know, write-offs and things. So, and we continue to really have that focus in driving the subparts of the generic business.
Right. And can you comment a bit on your strategy on the oral solid side over the course of next two, three years? Obviously, the pricing environment is slightly better than what it has been.
But do you feel that you, as a company, will again be looking to gain volumes or kind of chase volumes and then, in turn, kind of fill your capacities? Or do you think that it's not the right strategy to be going back to where this industry was two, three years back, and hence, it's a bit y our strategy should be a bit more cautious in terms of how you target the oral solids business?
Well, so our focus on the oral solids is the baseline. We want to manage it as efficiently as possible. You know, so very, very strong focus on cost improvements there through KSMs and other related spend, making sure that we don't have idle costs. So, you know, when in doing that, you know, you can't really afford to really hold on to capacities with the hope that you will share, right? I mean, so it's not to say that we will not be opportunistic. I mean, when there are opportunities, especially on our, you know, products where we have a strong position, we will certainly want to be able to, you know, gain volume as well as serve the market.
But, you know, we have, we have, optimized, and we'll continue to optimize the oral solids to minimize any idle costs and other measures that to ensure that we run that business as efficiently as possible, while, you know, driving the portfolio shift to complex generics.
Right. And sorry to just harp on a bit more on this. So a couple of years back, you had taken a call on discontinuing a portfolio of products which, I mean, which wasn't making sense on the margin front. Do you still stick to that strategy? Do you have a threshold margins below which you are not willing to work? It would be great if you can communicate what margins below you're not willing to work, but I mean, it might be difficult for you to comment, but does that strategy still hold irrespective of how the pricing environment behaves?
Absolutely. We are not going to sustain products that don't contribute to our P&L. So, you know, we have to, as much as, you know, we are very proud of our position as a company that serves a major cause on the generic front, we also have to, you know, be a viable manufacturer. So, you know, and it's not any particular margin, because every product has a lot of different. You know, can contribute to overheads and improve the margin for a site. So there's no one number that is a cut-off. But we have a very, very disciplined, you know, framework now on month-on-month basis to look at margins, look at products that are getting to low margin, and determine what our position is gonna be.
Got it. Thank you so much.
We're out of time, so maybe we can take last two questions.
Yeah. Thanks, Nikhil. We take the next question from Ritesh Rathod . Ritesh, are you there? Yeah, we take-
Yeah. Can you hear me?
Yeah, we can.
Thank you. Given the strong, free cash flow generation, and we are on a quarterly EBITDA run rate of INR 1,000 crore, we would be net cash in couple of quarters. Where do we deploy, we plan to deploy our free cash, which would be generating next two to three years? Would it be, any particular area, or would you like to give it back to shareholders? And do we have any formal payout policy?
So our dividend policy is not going to be very different from the past, because we believe that there are a lot of opportunities in our space to actually invest. You know, we believe that over time, we would be able to get to returns which would be far higher than what the individual shareholder would holder would be able to get for himself. And we have always been an acquisitive company, so as and when this proposition is compelling enough, we would look at various acquisitions. And we've also kind of you know, we are nurturing our specialty you know aspirations as well. So it is a question of time if we actually get to that. We've been studying this space for quite some time now.
Our first foray was obviously not very successful, but doesn't necessarily mean that we're gonna stay away from it for too longer time. It's just a question of time before we get back.
What would be the areas where you would like to invest if you want to put it in a priority, or in a descending way?
So also that, you know, while we'll be opportunistic, in terms of the areas that we can play and where we can make a difference. But respiratory is one that we really like based on the position that we have built. I mean, today, respiratory is, you know, over 25% of the company's global revenues. When you look at both, the India business as well as the U.S., Europe, Canada, all of the different markets that we have, and we have significant capabilities there. So certainly respiratory is one where we believe that we have the right to play and look at opportunities, to both, organically as well as inorganically, to build our portfolio. If we have other opportunities like Xopenex, we will certainly look at them seriously.
The other area that we like, based on our foray in Europe, neurology, you know, with NaMuscla, the orphan product that we have in Europe, we have, successfully launched it in multiple countries there, and have, started the study for a broader indication for the product. Even though it'll still be an orphan indication, and, looking to really expand that portfolio with other CNS neurology assets. So those two are certainly areas that, we are, looking at program, programmatically, and then, others opportunistically. Likewise, you know, we're looking at our therapy areas in India and, the TAs where, we want to build a stronger position for the future. You know, we are strategically looking at opportunities to buy, brands and portfolios.
In specialty, can you elaborate more what areas you will try to attempt this time, like either organically or inorganically?
Like I mentioned, the two that we have been looking at exploring are respiratory and neurology.
Okay. In U.S. also, you meant that?
Yes.
Apart from, of course, you know, opportunities if they arise in India as well.
Okay . Thank you. That's from my side.
Thanks, Ritesh. So that concludes the Q&A sessions. Thanks for the active participation. I now hand the conference over to the management for the closing comments. Thank you.
Thank you, everyone. Apologies for the poor audio this time, and we'll be happy to answer any questions that remain unanswered. But, you know, we are very energized by the performance, you know, our team has delivered over the last three quarters. Our team is very energized, you know, as you can imagine, and we expect to close this fiscal year pretty strong. Continuing on the momentum that we have built over the last three quarters, and starting the next fiscal year, very strong as well, to improve both revenues as well as profitability going forward. To get to our goal in the next three years, like Ramesh said, to that 23%-24% EBITDA.
So look forward to connecting with you again over the next couple of months as well as the next quarter. Thank you again for all of your questions on the call today.
Thanks, ma'am. So thank you very much to all the panelists and the participants. On behalf of Lupin Limited, that concludes this conference. Thank you for joining us, and you may now exit the webinar. Thank you.