Good evening, everybody.
Yeah.
Can you hear me?
Yeah, the voice is breaking, Vinita.
Can you hear me now?
Yeah. Yes, yes.
Hi, everyone. Very pleased to welcome you to our Q2 fiscal year 2024 earnings call. Online here I have our MD, Nilesh, our CFO, Ramesh, and our head of IR, Ravi, as well. We look forward to sharing our Q2 highlights and outlook for the fiscal year. We are very pleased to build on the momentum over the last couple of quarters and deliver significant improvement, as you saw, in operating margins, driven by growth across majority of our regions, U.S. launch of tiotropium, and continued focus on efficiencies. Our U.S. business delivered continued growth in revenues and margins for a fifth quarter in a row on the strength of a stable base business, launch of tiotropium, and overall strong performance on respiratory products. I mean, in the quarter, respiratory contributed 45% plus of our revenues.
We expect to sustain our business at the $200 million+ level now going forward, with a continued ramp-up of tiotropium and other new product launches in the second half and beyond. Switching to India, our business recorded growth in line with the market, with better-than-market performance in therapy areas like cardiology, respiratory, GI and women's health that we are building. The diabetes TA, which was in a degrowth mode, is back to growth, but we'll continue to build on it in the quarters to come. As we look at the second half, we expect the investment we made in expanding our sales force to get to a level of productivity that will help us build on our growth rate from the first half. We've already started seeing gains in the start of Q3.
October has been strong, and we expect to continue that in the rest of Q3 and Q4 for our India business. Apart from U.S. and India, other regions performed well, too. In particular, Europe recorded strong growth due to ramp-up of generic Fostair in our direct markets like U.K. and Germany, as well as through partners in other parts of EU. On the R&D and pipeline front, we have continued to build on the momentum with both material first to files and complex generics. We are very pleased to get key product approvals like generic tolvaptan and generic XYWAV in October, and will drive a big part of growth in the next couple of years, in particular, tolvaptan.
Our pipeline is now positioned well to evolve our business into complex generics with inhalation, injectables and, complex ophthalmic products, you know, given the Pithampur unit two clearance. On the compliance front, we have continued to make progress and are committed to ensure that we get all our sites to a consistent and sustainable level of compliance. With a strong focus on delivering the pipeline, coupled with compliance gains, we can now see a clear path to sustainable growth over the next few years for our business. We are delighted to deliver strong performance in the first half of the fiscal year and look forward to executing on our new product launches, continued momentum in India and other markets, strong focus on improving our operating margins in the second half. With this, I will hand it over to Ramesh for a deeper analysis of our performance.
Thank you, Vinita, and good evening, friends. Season's greeting to you and your families. I welcome you all to our Q2 FY 2024 earnings call. On the last occasion that we met, we mentioned that we would strive to achieve around 18% EBITDA margins by Q4 of the current year. I'm happy that we have delivered on our promise in this quarter itself. Now, dive, diving deeper into the numbers, sales for Q2 FY 2024 came in at INR 4,939 crores, as compared to INR 4,091 crores in Q2 last year, a growth of 20.7% year-on-year. On a quarter-on-quarter basis, the company reported growth of 4.2% and 8.9% after excluding NCE income over Q1 FY 2024. We have registered robust growth across most of our key geographies.
North America has grown at a strong 40% year-on-year and 17.4% quarter-on-quarter. India business has grown at 6.8% year-on-year, whilst EMEA grew at 24% year-on-year. Our API business registered growth of 7% year-on-year. Going on to the US business. During the quarter, the US business recorded a sale of $213 million, registering a growth of 34% year-on-year and 18% on quarter-on-quarter basis. Just to indicate the size of the ramp-up, this number was $159 million in Q2 FY 2023. This growth has been led by new products and by also our legacy products maintaining their market share.
I'm happy to share that our strategy to build complex portfolio is bearing shape, and today, innovative products are more than 40% of our US sales. Coming to India. The India region formulations business has grown by 6.9% year-on-year. Our growth, excluding NLEM, is 8.9% year-on-year. As per IQVIA, all our key segments except for anti-diabetes have grown faster than the market in the quarter, including cardiovascular space, respiratory, GI, and gynecology. Even in the anti-diabetes space, our non-in-licensed portfolio has grown at 10% vis-a-vis IPM category growth of 4.9%. Currently, the in-licensed portfolio constitutes around 13% of our IRF business, vis-a-vis 15.5% in FY 2023.
Speaking about EMEA region, which constitutes our EU region and South Africa business, has performed exceptionally well during the quarter, with a strong growth of 24% year-on-year. Growth in EU has been driven by our inhalations business going strong, with products like Lufolbek and Pleqoo gaining additional share and entering newer markets. EU also saw increased tender sales. I'm delighted to share that we recorded the highest ever sale in Germany during the quarter. Going on to the margins front. Then, coming to the profitability, Q2 FY 2024 gross margins are at 65.5%, which has increased 170 basis points from 63.8% ex NCE income in Q1 FY 2024, and materially from 58.1% in Q2 last year.
This improvement was driven by multiple factors, which includes better product mix, lower share of our in-licensed products, commodity deflation, increased volumes, and realization of savings from few of the cost improvement initiatives like freight and other things that we took on. Employee benefits expense at INR 861 crore has increased by 11.5% year-on-year in Q2 FY 2024, which translates to approximately 17.4% of sales, as compared to 18.6% of adjusted sales, excluding NCE in Q1, and 18.9% in Q2 last year. Whilst there has been a reduction in percentage to sales due to our cost optimization initiatives, I would like to mention that there is an offsetting impact due to the field force expansion, which we undertook last year and other new initiatives. Manufacturing and other expenses.
Q2 FY 2024 manufacturing other expenses came in at INR 1,552 crores, which translates to approximately 31.4% of sales, as compared to 32.5% of adjusted sales excluding NCE in Q1, and 30% in Q2 last year. The year-on-year increase is on account of higher volumes, higher spends in R&D, increased consultancy charges for nitrosamine impurities, increase in selling and promotion, expenses, travel expenses due to the field force expansion, and the like. Speaking about R&D. R&D is INR 376 crores, which constitutes 7.6% of sales in Q2 FY 2024, as compared to INR 338 crores at 8% sales of Q2 FY 2023. The increase in R&D year-on-year is on account of investments in newer platforms of biosimilars, injectables, and the like.
For the full year, we expect R&D to be around INR 1,500 crore-INR 1,600 crore. EBITDA, this has resulted in driving the EBITDA margins higher. Excluding Forex and other income, EBITDA was at INR 923 crore, up by 113% year-on-year. Margins for the quarter are significantly higher at 18.7%, vis-a-vis 14.4% in Q1 FY 2024, excluding of course the NCE income, and 10.6% in Q2 last year. Going on to the ETR front. Our ETR was 22.9% in Q2, against Q1 FY 2024 of 18.9%. The ETR for the full year is expected to remain between 21% and 22%. PAT for the quarter is INR 490 crore, demonstrating a stellar growth of 278% year-on-year.
Diluted EPS is 10.72 per share. You know, the face value, of course, is INR 2. Going on to balance sheet. Operating working capital was INR 5,576 crore as at 30 September 2023, which translates to 103 operating days. This is reduced from 119 days at the end of the previous fiscal. Net debt for the quarter, at the end of the quarter, stands at INR 1,806 crore. This reduced from INR 2,526 crore at the end of March 2023. Gross debt has reduced by INR 720 crore during this period. Friends, I would also like to report about our initiatives on the ESG front. I would like to mention an important update here.
We've accelerated our ESG efforts at a significant pace over the last two years. We have now also received the external validation of our efforts in the form of a latest assessment by the S&P Global Corporate Sustainability Assessment. And the great pride that I would like to announce that our ESG score is 68. Our journey on S&P Global CSA, which is of course DJSI, began with a score of 17 in 2021. Last year, we marked a step forward with a score of 46. Today, we stand at 68, which places us at the 95 percentile of the global pharma industry. We'll of course continue on these efforts and gain ground in the years to come. With this, I would like to open the floor for discussions.
Thank you, very much, sir. We will now begin the question and answer session. Please raise your hands from the Participation tab on the screen to ask questions. We will wait for 30 seconds for the queue to assemble. Thank you.
... Okay, so the first question is from, Mansi Desai. Go on, ma'am.
Thank you for taking my questions. My first question is on the U.S. business. So while Spiriva, you know, looks like, you know, has contributed meaningfully in, you know, Q2, and so has darunavir, if one were to exclude these two products, have we seen sequential growth in the U.S. base?
Yeah, actually, we have seen our in-line products pretty stable, you know, growing a bit, and the new product launch is contributing as well. I'd say Darunavir was launched in Q1, so there was pipeline build in Q1. So the Darunavir level in Q2 is obviously lower than Q1.
Okay, that helps. And what is your sense on the price erosion levels in the market? You know, any different from what we saw in Q1?
Yeah, we've seen a level of stabilization at that mid-single digit level on our baseline products, in-line products. So, hopefully, that continues, you know.
Got it. And, secondly, you know, on Spiriva itself, you know, our initial expectation was that this product probably will see ramp up similar to what we saw in albuterol, but clearly it looks like, you know, it has done better than that. So, you know, how should we look at market share ramp up here, and any visibility on the AG launch?
Yeah. So, the ramp up has been pretty much along the lines that we anticipated. We expected that it would start at 25% level, and then, as we looked at other analogues, Advair and other inhalation products, over a year or so, build up to 35%, you know, 40% level. And we're seeing that right now, our substitution rate is 25%.
Okay.
You know, and it's hard to predict, you know, when an AG would launch and if an AG would launch, but at this point, we are just working hard to keep up with the demand, as well as make sure that we scale up the business effectively for the product.
Got it. I have more questions. I'll join back the queue.
Thank you, very much, Mansi, for the question. We'll take the next question from Neha. Neha Manpuria.
Thanks for taking my question. Vinita, if we do think, you know, Spiriva ramps up to 35%-40% market share in the next year, A, would this require, in your view, more pricing action from us, you know, to go after this market share? And secondly, if that is the case, you know, should we then expect the current base that we've reported to see a step up over the next few quarters? You know, because in your opening comments, I think you mentioned that we'll keep the base at 200+, but shouldn't we see a step up from the current base if we get to the 35%-40%?
Yeah. So Neha, we would expect pricing to be stable as we ramp up the product. You know, we don't see any additional entrants in the near term, so we don't see a reason for price not to be stable unless we see, you know, a challenge in substitution. But like I said, substitution is along the lines of what we had anticipated, so it's been a very effective launch from our team.
I'd say that, you know, in Q2, we have some effect of the pipeline fill on Spiriva, you know, that we're continuing to see in Q3, but we think it might level off a little bit, as you know, you know, gets into sync with the product substitution.
Mm-hmm.
And, you know, therefore, we think that, you know, certainly, tiotropium will continue to ramp up, especially into the next year. But when we look quarter after quarter, we might see some impact of, inventory correction over the next couple of quarters. And, you know, as we also lose exclusivity on couple of other products where we have, exclusivity, we might see some-
Mm-hmm.
downside. Of course, we have products that help us grow the business, which gives us confidence that both in fiscal year 2025 and in particular in fiscal year 2026, you know, given the tiotropium ramp-up, plus injectables, plus ophthalmic products that we have on the new product launch calendar, we should grow the business, you know, pretty well.
Got it. You know, I remember you once mentioning that, you know, you think you have enough capacity to get to your fair share. Should I assume the 35%-40% is the fair share that you were talking about, and, you know, capacity is not an issue, therefore, given you- given that number?
Yes. Yeah, we have-
Okay.
Built capacity not only for the U.S., but also for our other markets. So in the next 6-12 months, we expect to launch in Australia, Canada, Europe, you know, multiple regions that we build capacity for. So we are well positioned.
Got it. Ramesh, on the you know, cost side, I understand that the employee cost obviously has gone up this year with the MR addition that we've seen. But the other expenses also seem to be, you know, inching up. It went up last quarter on a quarter-on-quarter basis. It's gone up again this quarter, you know, on a sequential basis. You know, other than the SG&A spend associated with the India business, is there anything else that we are investing in outside of R&D, which is leading to this quarter-on-quarter increase?
Firstly, I would like to stress that you should see this, you know, we saw this the previous quarter, where there's of course been an increase in operating leverage of just about 1.2%. But going on to a year-on-year, yes, there has been, you know, an increase, which is close to 26%. But I would also like to add that, you should if you look at the level of activity, you know, in terms of, you know, the volumes of API and formulations, that have grown significantly, that's actually kind of reflected in the inventory buildup, you know, and that actually translates to slightly increased, you know, gross margins.
Which, in turn, kind of, you know, reverts back to a higher increase from our expense base itself. But I would also again add that, you know, there is of course an element of one-time expenditure, which is also contained in here. So, you know, our focus on driving down costs is still very much there. We expect to kind of keep it on a leash around the levels that we just spoke about in the quarters to come.
Sorry, what was this one-time expenditure that you're alluding to?
The one-time expenditure is, you know, is captured, because of, essentially the expenses that we incurred on, the CDM or spin-off. You know, essentially, the stamp duties and other costs have been cut on that. And we also took some provisions, you know, relating to, some issues that we had out here.
So what is the base, you know, cost, excluding all of these one-offs? I mean, just to get a sense of what the fair number should be going forward.
I would say that it should be closer to the 30% mark.
Okay. Including R&D.
Yeah, around that, you know, so give or take, based again, on the level of activity and the like.
Got it. Thank you so much.
Thank you so much, ma'am. The next question is from Damayanti Kerai. Go ahead, ma'am.
Yeah, hi. Thank you for the opportunity. After a remarkable improvement in first half, in terms of operating performance, how should we look at margin trends ahead? So, as you said earlier, you expected 18% margin by end of this fiscal, but it came bit earlier and now things seems to be on improving path. So how should we see margin trajectory from here on?
So we think, you know, in so far as America is concerned, the overall, you know, the sales there should hover around, you know, the $200 million mark. And there would, of course, be, you know, ramp up in other parts, including India. So I would actually expect, you know, the growth trajectory to kind of continue, and the second half would also be around the 18% mark, you know, in the third and fourth quarters.
Second half, broadly around 18% margin.
Yes.
So maybe for the full year, we could be in higher teens.
It's obviously because the first three quarters are in the 18% and 14.5% in the first quarter, you know, you can average it out.
Okay. And, just want to understand, ma'am mentioned in her opening comment that now, 200+ label is sustainable for the U.S. business, and that includes Spiriva and all other, new launches, right? Or, how should we look at that?
That's right. That's right.
Okay. Just another question on U.S. side. How much is branded portfolio contribution right now of the total U.S. sales?
It is small. It's under INR 5 million for the quarter.
Under 500. Okay.
No, INR 5 million.
5 million. Okay. Yeah, sure. And my last question is, your presentation mentioned, you are building up quite well on the complex project side, 40+ injectables and then 20+ inhalers, et cetera. In next, say, two to three years, how many filings we can see on the complex opportunity side, inhalers, injectables, et cetera? And if you can also call out some near-term key filings, which you are expecting.
Sure. So majority of our, you know, R&D focus has been on the complex generics, in particular, inhalation and injectables, ophthalmics as well. As well as first-to-file, exclusive first-to-file in particular. And, you know, we have got a good pipeline in place right now to drive, you know, the business growth towards complex generics. Already a good part of it, in the U.S., is now respiratory.
But as I look at the next two years, with the pipeline that we have in place, you know, on the ophthalmic front, given the Pithampur Unit- 2 clearance, multiple ophthalmics, five or six products that we expect to bring to market, you know, second half of this fiscal year, as well as into the next fiscal year. You know, we have products like Bromday, BromSite, ioteprednol, Prolensa, all that we're expecting approval for, and then launch over the next couple of years. On the injectable front, we have a good pipeline now in place, multiple products in development. You know, few products that we expect to launch in the current fiscal year.
We think ganirelix famotidine will launch this fiscal year. Then, next fiscal year, we hope to launch glucagon. That would be a material one for us. And then, depending on litigation outcome, also, you know, liraglutide in fiscal year 2026. And then, lastly, I would say on the injectable front, risperidone Consta, our long-acting risperidone out of Nanomi, should come to market by fiscal year 2026. So both our complex injectables ramp up in, you know, the second half of this year, but more so in fiscal year 2025. And then, you know, also the first to file oral solids, like tolvaptan in fiscal year 2026.
We're very pleased to get that approval in October, our goal date. As well as, you know, products like mirabegron and Oracea and doxycycline. We expect, you know, both approvals as well as litigation outcome over the next couple of months, that will enable us to confirm launch dates, but we expect to launch in the next, you know, two years.
Okay, that's helpful. Thank you very much.
Thank you so much, ma'am. The next question is from Karan Vora. Karan, you can go ahead.
Yeah.
Karan, go-
Thank you for taking my question. My first question is on the India business. So, going forward, assuming the IPM grows at, say, high single digits, do you think even on a base which has the in-licensed diabetic product which went off patent, we can still outperform the IPM over the medium term, or it will be a slightly taller?
Yes, Karan, that's clearly the plan. The plan is to continue growing at better than the market. Diabetes is the one category that has been a challenge for us, but, you know, that also has, has come around to growth now for us. So certainly we would expect growth to continue better than the market for the mid to long term.
Okay. And how do you, how do you split this? Say, if you grow at 10%, how do we split that out into price and volume?
So usually it's, I think for the industry, it is more or less similar. I think you usually see 2%-3% volume increase. You see another couple of percentage points from new introductions, and the balance comes from price increase.
Okay, thank you. Second question, on Spiriva. So just needed some clarity. So basically, is this understanding correct, that because this was the first quarter of launch, there would be some amount of channel filling, and so Q3 and Q4, the amount of Spiriva which you book would be lower than Q2, so that could impact your U.S. QOQ growth? Is that understanding correct?
Yes, there may be some phasing. We're still tracking it very closely, so, you know, we'll find out over the next couple of months. But, we would expect that there will be some leveling off, in the next month or so.
Okay. Okay, okay. Just two quick ones on U.S. business. Any update on Revlimid launch?
Yeah, that is out a couple of years for us. You know, so it's, I think fiscal year 2026, if I'm not mistaken.
Okay. And lastly, at the current run rate, is the U.S. business EBITDA and [inaudible] break even or, or not? If you could give some qualitative sense. Thank you.
Yeah, it is. At the current level, it is EBITDA accretive to the company average margins. And, yeah, we hope that will continue at this pace and get improve further as we, you know, ramp up the business.
Yeah.
Thanks, Karan. The next question is from Kunal Dhamesha. Kunal, go ahead.
Thank you.
Thank you for the opportunity. First one on the biosimilar, is there any update on the Pune facility and pegfilgrastim filing for us?
Yeah, I can take that. So, we had the EIR, which was issued by the FDA. We identified areas of improvement in the EIR, which were actually underway, and we hope to send an update to the agency by March, post which we would follow up for an approval.
Sure. And, what would be our strategy here, for commercializing? Let's say, if we get approval in FY 2025, will there be any field force required, you know, front-end commercial infra?
Yes. So we're tracking the market very closely right now, and of course, waiting for the site and product approval before making concrete plans. But, you know, as the market evolves, you know, the access model gets a little bit simpler as we see it, you know, with established channels in the marketplace. So, you know, we are constantly tracking and, you know, the plan, even with a direct-to-market sales force effort, was to really have a very targeted niche sales force, that can double up with our injectable business, you know, so we can have some operating leverage as opposed to having a single product investment. So, so watching that carefully....
You know, and we also have, apart from our own plans and potential to launch, we also have interest from partners. We're gonna closely track our OBI product development to determine what is the best route for us to go.
Sure. And any update on ranibizumab? And that is also something that we are developing, right?
Yeah, so on-
Yeah, so-
Go ahead.
Go ahead, Vinita. So I was just saying, on ranibizumab, we're, you know, well on our way on our clinical trial. We've got the last patient in. It's still gonna be about a year to do the filing itself. But this is the clear filing for the next fiscal.
Sure. The second question is on the seasonal product update, uptake in the U.S. You know, typically during this time around, there is flu season, and we have cephalosporin as well as Tamiflu. So have we seen any uptake, you know, in this quarter, or probably we could see it in next quarter?
We've seen some uptake in this quarter in anticipation of flu season. The season has just started, so we just started the last couple of weeks tracking. So it has ramped up. But we'll have to really get into the next month or two to see how strong the flu season is gonna be. It certainly has ramped up, but it's at a level below last year, right now.
So like to, like, it's level below, at least from October and November, is the way to-
That's right.
Okay.
Yeah.
Perfect. Thank you. All the best, and Happy Diwali!
Thank you. Happy Diwali to you as well.
Thank you, Kunal. The next question is from Nitin Agarwal.
Hi, thanks for taking my question. Vinita, on the, when you talk about 25% market share on Spiriva, we, we take into account the entire portfolio of Spiriva, Respimat, HandiHaler, both, or we just, you know, we talk in terms of the single strength?
I'm talking about the HandiHaler.
Okay, percentage of that market. But how do you see, how do you see the substitution happening from Respimat also? I mean, how do you see that, playing out?
Actually, the encouraging sign for us was, you know, in the last couple of years, we have seen the HandiHaler decline versus Respimat, that the brand has been working hard to convert. And they had also moved their couponing strategy to the Respimat to drive hard conversion. We actually saw in the last couple of months a flattening, so no decline in the HandiHaler, which is a promising sign. And we hope that, as we continue to ramp up the product, you know, as it gets utilized, that it will definitely flatten the decline or, you know, hopefully take some share from the overall molecule.
And secondly, you talked about, you know, U.S. stabilizing around $4 million now. You know, when you take again a two-year view from here on, I mean, where do you see the next milestones? Something like a $250 million whereabouts, you know, when you start to hit that, more consistent level?
I'd say that, you know, next year is gonna be a ramp-up year for us, both with TO as well as the other product launches. And certainly fiscal year 2026 is one where we see with the, on the strength of, you know, the new product launches, tolvaptan, which is gonna be a material one for us, potentially liraglutide, depending on, of course, approval as well as litigation. And the ophthalmic injectable, ramp up. We expect to be at that closer to the $250 million a quarter.
When is the tolvaptan launch? What timeline are you looking for that, potentially?
It's fiscal year 2026.
Okay. And last one. You know, we've seen a reasonable ramp-up in our non-U.S. export geographies, you know, across a bunch of the geographies. You know, any color on, you know, the kind of scale-up which has come through and where, you know, where are these from profitability perspective and contribution to our overall profitability, as we go forward?
Yeah, certainly, I mean, you know, apart from the U.S., when we think about, apart from U.S. and India, Europe has been a very strong contributor this fiscal year so far, and we expect that to continue over the next couple of years. Likewise, Australia, Canada, you know, all of them have had a pretty strong run rate over the next, or, you know, over the last couple of quarters. Driven by, again, complex generics. I mean, if you look at Europe, Fostair generic has become our largest product there, and we are continuing to ramp it up. So respiratory has become a big part of the focus in Europe, in Canada as well. We're looking forward to launching tiotropium soon.
Australia as well, we expect to launch tiotropium soon. So, so we do. I, I believe we are under indexed right now in the ex-U.S. developed markets. You know, and our complex generic portfolio, inhalation, also biosimilars and injectables, really, will enable us to grow these markets as well, you know, so they become a larger part of the company over the next three to five years.
So, this group as a whole, can it sort of compound and maintain over a period of time?
... Yeah, you know, for sure. Already, Europe is ramped up, Canada and Australia are already at a good level. So we would expect them to be in the mid-teens.
Last one, if I can. On the Consta product, where are we on the filing and approval process, October 26 launch on that?
Yes. So, we are filing it this month. You know, it's in the final stages of the filing. We would hope by fiscal year 2026, you know, that gives us a couple of cycles to get approval.
Thank you so much, Ms. Vinita. Happy to launch you.
Thank you.
Thank you, so much, Nilesh. We'll take the next question from Bino Pathiparampil. Bino, are you there?
Yes. Hi, good morning and good evening. Hi, Vinita, just a follow-up on Spiriva. You had mentioned earlier that you are seeing a substitution rate of 25%. How is this defined? What does that mean?
That's a prescription ramp-up rate that we are seeing of the generic versus the brand HandiHaler.
Okay. And, how, you know, one bottle or one canister, however you call it, how long does it typically last for a patient? One month, two month?
I think it's a 60-day supply, if I'm not mistaken.
It's a 30 days, Vinita, I think.
Thirty days.
Thirty days?
Yeah.
Okay. So, if substitution rate is 25%, then 30 days we should be hitting 25% market share, right? I mean, am I... Is there something wrong with that assumption?
Yeah, I think so. That's just right.
Okay. And second-
Yeah, that's the kind of unit share. We are seeing the unit and prescription share, you know, coming close together at this point.
Okay. Or are you talking about this only new prescription? I mean, people going for refills are still, you know, the substitution rate is not that high. Is that the case?
No, no. No, we are seeing overall substitution, not just NRx, you know?
Okay, understood. Second, a follow-up on mirabegron. You mentioned that in a couple of months you are expecting some litigation outcome, which will decide the launch date. So, could you let me know, you know, in case the litigation outcome is favorable, then what could be the launch date? And if it is unfavorable, then what could be the launch date?
So, we have prevailed on one major patent, you know, in litigation, you know, in the district court. That's on appeal right now. We have settled on another, and the brand has continued to file patents, you know, that we have been battling. So... And we are actively working on, you know, our litigation strategy to determine, you know, how soon we can launch.
Okay. So, so what is the earliest possible or the latest possible? Is there a range that you can give?
I wouldn't be able to share an actual launch date. It's fair to say that we are actively working on this one. You know, the fact that we won on the major patent was very heartening for us, gives us confidence of our ability to launch.
Understood. Just one last one, on Nascobal, Diastat, aren't these now already kind of part of the base? Is it currently in three Q or we are yet to ramp up?
No. So we are yet to ramp up. Actually, Diastat we launched last week. It was a fairly challenging product, but the team has launched it effectively. And Nascobal, we expect to launch in the next week. So both of those will contribute to the growth, you know, in Q3 and Q4.
Perfect. Thank you, I'll join back.
Thank you.
Thanks, Bino. The next question is from Sanjay Kular. Sanjay, you can go ahead. Hello, Sanjay?
Sanjay, you're on mute, I think.
Hello.
Can you hear me, sir?
Yes, yes, we can.
Okay. First of all, I would like to compliment Vinita ji for delivering excellent results. I have a couple of questions. Madam, where do you see our company in over next two, three years? As you mentioned, that we are on a steady growth plan, so next target is $5 billion, maybe three to five years down the line. Second question is, you know, when do we surpass the record profits achieved during Sri DBG's times? You know, we achieved record profits. So when do you see we achieve this in next two, three years?
Two very good questions. You know, both the long-term prospects on the revenue front and profitability. And our goal is really to get our company back to consistent growth on revenues as well as improve our profitability. You know, so profitable growth more than just growth. So on the revenue front, we see, I mean, fiscal year 2026 is going to be a material year for us, as I mentioned in the last couple of minutes, given the material launches, as well as ramp-up of current products, continuing to solidify the gains that we have made.
Okay.
And then I'd say in a five year timeframe, we expect the overall company business to grow substantially.
All right. That's fantastic.
... And both across the U.S. as well as India, and as well as, you know, other parts of the market, the developed markets that we are currently under-indexed on. We should, they should be larger part of our business in five years. I'd say on the developed market side, you know, U.S. as well as Europe, Canada, Australia, but we would see majority of our portfolio, two-thirds of it switching to complex generics.
Okay.
-based on the investment and that we've made and the execution so far, inhalation, injectables, you know, really contributing a material part of our growth over the next five years.
Okay.
On the profitability front, you know, we have come a long way over the last year and a half. Still a long way to go.
Yeah.
you know, our highs of high 20s margins
Yeah.
Certainly are aspirational for us. Right now, we can see a path over the next few years to get to a good 20%+.
Okay.
Mid-20s is our, our goal, you know, to really close the gap with our peers. There's no reason why we should be below that. But as we continue to look at the company prospects beyond five years, and look at investment plans, in particular, in areas like specialty, which long-term are our aspiration for our organization, we'll have to determine what kind of investments we make. So, we'd hope to get to, you know, 20%+ , then the mid-20s, and then we'll determine what's the best way to grow our organization for the long term.
Okay. One last thing, madam. You know, I used to meet DBG when, you know, I used to be friend with him. He used to say, "Lupin will be number one pharma company from India." So, you know, I, I'm sure he, your dream will also be that. So do you see happening in next five years, seven years down the line, madam?
Yeah. What we are, you know, given the complexity of our business across the globe, you know, India being a big part of it, U.S. being a big part of it, and our chosen strategy of going into complex generics as opposed to a broad spectrum generic company, I would say that, you know, at this point, our focus is to be, to be the best in what we do.
Sure.
You know, we want to be a leader in the areas that we have chosen. So, like, respiratory is one that is turning out to be one of our biggest growth drivers for the organization globally. We're already a big player in India, and we want to be, you know, a material player ex-India as well. It's a, you know, big part of our business in the U.S. and as well as a growing part in other parts of the world. So I'd say, you know, the areas that we choose to be in, we'll target to be the best.
Okay, madam. Thank you very much, and wish you a Happy Diwali!
Thank you. Happy Diwali to you as well.
Thank you.
Thanks, Sanjay. Before we proceed, just a reminder to all the participants to raise your hands for further questions. We'll take the next question from Ankush Mahajan. Thank you.
Sir, thanks for the opportunity. Ma'am, we have a U.S. revenue in the range of $211 million now. So this run rate, could you give me some sense of what kind of a run rate that we can expect in upcoming quarters? Because you already have inched to $211 million from $185 million... $181 million.
Yes, as I mentioned, 200+ is what you should expect.
For the upcoming quarters?
That's right.
Thank you, ma'am. Thanks.
You're welcome.
Thank you. So I think, that, pretty much ends, brings us to the end of the Q&A session. I now hand the conference over to the management for, closing comments. Thank you.
Thank you, friends. Thank you for all your questions. As we mentioned, we are very excited about the progress we have made so far. We look forward to a very successful second half of the year and building from there into the next two fiscal years. So look forward to strong quarters ahead and reporting the same back to you, all of you. Given the holiday season, wishing all of you a very happy Diwali and a prosperous New Year. Have a wonderful holiday weekend and look forward to speaking with you again next quarter. Thank you.
Thank you so much, ma'am. So, on behalf of Lupin Limited, that concludes this conference. Thank you for joining us, and before we sign off, here's wishing all of you all a very happy Diwali. And, now you may exit the webinar. Thank you very much.