Good morning, ladies and gentlemen. Welcome to the Q2 FY 2024 earnings conference call of Glenmark Pharmaceuticals Limited. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Utkarsh Gandhi, General Manager, Investor Relations for Glenmark Pharmaceuticals. Thank you, and over to you, sir.
Thank you, Lizanne. Good morning, everyone. Welcome to the Q2 FY 2024 results conference call of Glenmark Pharmaceuticals Limited. We'll just review the overall performance of the company for the second quarter of FY 2024. For the second quarter of FY 2024, Glenmark's consolidated revenue from operations was at INR 3,587.9 million, as against INR 3,375.2 million in the corresponding quarter last year, recording an overall year-on-year growth of 6.3%. For the six months ended September 30th, 2023, Glenmark's consolidated revenue was INR 69,895 million, as against INR 61,525 million, recording an increase of 13.6%. Some key updates on the formulation business starting with India.
Sales from the formulation business in India in the second quarter of FY 2024 were at INR 11,217 million, as against INR 10,916 million in the corresponding quarter last year, recording a year-on-year growth of 2.8%. The lower growth was mainly on account of the impact of the divestment of few non-core brands and some impact of the NLEM price revisions, as well as an overall slowdown in the acute respiratory and dermatology therapy areas in the first six months of FY 2024. The India business contribution was at 31.3% in the second quarter of FY 2024, compared to 32.3% last year. The Indian pharma market witnessed a slowdown in the acute segment, particularly on the respiratory side.
Volume growth in the key therapy areas, such as respiratory and dermatology, was hence impacted in the first six months. Accordingly, as per IQVIA data, for the second quarter, Glenmark India formulation business recorded a growth of 5.4%, compared to overall market growth of about 6.9%. In the second quarter, Glenmark's growth remained strong in the cardiac segment, but was impacted in other therapy areas. Glenmark's India business continued to be ranked fourteenth, with a market share of 2.1%, 2.11%, as per IQVIA MAT September data.
The company continues to have nine brands in the IPM top 300, and in terms of key therapeutic areas, Glenmark is ranked 2nd in both dermatology and respiratory, and 5th in cardiac segment and 17th in the diabetes segment as per IQVIA MAT September data. Glenmark has improved its market share marginally in spite of the challenging environment in Q2. If you see the IQVIA MAT September data, we have improved our market share in most of our therapy areas, most of the key therapy areas. In August 2023, Glenmark also announced that it had joined with OMRON Healthcare India, the Indian arm of the Japanese global leader in home blood pressure monitoring and solutions for cardiovascular disease, to raise awareness on measuring blood pressure at home from the age of 18.
This collaboration is named as Take Charge at Eighteen initiative and comprises of generating effective communication to enhance awareness about blood pressure monitoring in India. The company continues to have a healthy pipeline of differentiated products, which it plans to launch in the market going forward. In terms of the consumer care business in India, primary sales for the DCC business in the second quarter were INR 634 million, with a growth of 15%. Our flagship brand, Candid Powder, delivered revenue growth of 10% in the second quarter. La Shield portfolio delivered 23% growth, and the Scalpe+ portfolio recorded about 29% growth.
Scalpe+ also recorded 41% growth in new-to-brand orders, and it is also amongst the leading anti-dandruff shampoos in large e-commerce channels such as Amazon. And recently, Candid Dusting Powder was also recognized with the The Economic Times Iconic Brand Awards in 2023. Moving on to North America. The North America business registered a revenue of INR 7,392 million, which is about $89.4 million US dollars for the second quarter, as against revenue of INR 7,533 million, which is about $95 million for the second quarter of FY 2023. This translates into a YOY decline of about 1.9%. For the second quarter, the North America business contribution was at about 20.6%, compared to 22% last year.
In the second quarter, Glenmark launched the previously approved, norethindrone ethinyl estradiol capsule and ferrous fumarate capsule, the generic for Taytulla. Glenmark received approval and launched saxagliptin tablets and tacrolimus ointment, 0.03%. Glenmark also launched varenicline tablets through a partnership. These launches are expected to contribute to the overall sales growth for the region, starting the third quarter of FY 2024. Glenmark filed 2 NDAs during the second quarter, and the company plans to file a total of 10-12 NDAs for FY 2024. Glenmark's marketing portfolio through September 30th consists of 185 generic products authorized for distribution in the U.S. market, and the company currently has 51 applications pending at various stages of the approval process with the U.S. FDA, of which 21 are Para IV applications.
In August 2023, Glenmark Pharmaceuticals Inc. announced that it had entered into an agreement with the US Department of Justice Antitrust Division, to resolve all of its court proceedings with the DOJ, involving historical pricing practices by former employees relating to the generic drug, pravastatin, between 2013 and 2015. The company has entered into a three-year deferred prosecution agreement, and if the company adheres to the terms of the agreement, including payment of $30 million, payable in 6 installments, the DOJ will dismiss the pending superseding indictment. Moving on to Europe. Glenmark's Europe operations revenue for the second quarter of FY 2024 were at INR 5,997 million, as against, rupees 3,785 million, recording a year-on-year growth of 58.4%.
Europe business contributes 16.7% of the total revenues as of Q2 FY 2024, compared to about 11% last year. Glenmark revenue, European operations continued their strong trajectory, driven by, a robust uptick in the branded business and a sustained growth in the generics business as well. The Western European business clocked, strong 30% growth for Q2, mainly led by, the key markets such as U.K., which recorded strong growth on the back of generic business, as well as uptake from the respiratory pipeline. The Czech and Poland markets in the Central and Eastern European region also recorded strong double-digit sales growth during the quarter. Glenmark continues to outperform the Czech market in terms of growth as per IQVIA MAT September data. The respiratory portfolio launched by Glenmark in Europe continues to do well.
Some of the key brands, such as Ryaltris and Salmex, continue to sustain their market share, both in terms of value as well as volume, across the Central and particularly across the CEE markets. During the second quarter, Glenmark also launched Ryaltris in Slovakia, which is another key CEE market for us. Menarini, Glenmark's partner for Ryaltris in the European market, recorded strong growth across multiple markets where it has launched the product. In Q2, Glenmark Specialty, a subsidiary of Glenmark and Cosmo, announced the signing and distribution agreements for Winlevi, which is clascoterone cream 1% in Europe and South Africa. Under the terms, Glenmark will receive the exclusive right to commercialize Winlevi in 15 EU markets, as well as South Africa and the U.K.
Cassiopea, which is a subsidiary of Cosmo, shall be responsible for the marketing authorization submission at the EMA, and Glenmark will undertake the registration for the product in the U.K. and South Africa. ROW region. For the second quarter of FY 2024, revenue from the ROW region was at INR 7,324 million, as against INR 6,154 million for the corresponding quarter last year, recording a growth of 19%. For the second quarter, the ROW business contribution was 20.4%, compared to 18% last year. The company continued to witness strong growth in the base business across the sub-regions of the ROW market. In Russia, as per IQVIA Q2 and MAT data, Glenmark business recorded 16% and 17% growth in value respectively.
This has been driven by key brands, including Ascoril, Momate, Ryaltris. Ryaltris has sustained its momentum and continues to gain market share even during the second quarter. In terms of key therapeutic areas, Glenmark recorded 21% growth in value in the dermatology segment versus the overall dermatology market growth of about 9.6%, as per MAT September data. Amongst the dermatology companies, Glenmark is now ranked eighth as per the MAT September data. Amongst the companies present in the expectorant market, Glenmark maintains a strong position, ranking second. Key recent launches in Russia include Ascoril LS and Fenistat, which is the dimetindene gel. The Asia region recorded about 10% growth in secondary sales, driven by markets like Philippines, Sri Lanka and Vietnam.
Dermatology and respiratory continue to be the key therapeutic areas, contributing significantly to the overall sales in Asia. Ryaltris, which was launched by Glenmark in Malaysia in the first quarter of FY 2024, has seen a strong pickup in the market. Ryaltris, also in Australia, is launched by a partner, continues to hold about 18% share across the top allergic rhinitis products. And in South Korea, where the product was launched recently by our partner, Yuhan Corporation, Ryaltris is now ranked first in the combination prescription market, and fourth in the overall prescription market for nasal sprays. So it has seen a strong start in South Korea as well. The Middle East and Africa region recorded about 15% growth in sales during the second quarter of FY 2024.
Glenmark continues to be ranked third in the overall Kenya market and has recorded 25% growth in secondary sales. Further, the company continued to achieve strong secondary sales growth across other key markets in the region, like South Africa, UAE, and other African markets. Respiratory and dermatology again are the key therapeutic areas in this region. And the Ryaltris, which was launched in Saudi Arabia in the first quarter of FY 2024, the product has received good response in the market. The product will be launched in other in Middle East Africa markets in Q3 and Q4 as well. Latin America achieved double-digit growth in second quarter of FY 2024. The respiratory portfolio remained the key contributor for Glenmark in this region.
Glenmark Brazil achieved about 20% growth in the covered market, as per IQVIA, YTD August, 2023 data, and it continues to maintain its rank amongst the top companies in the covered market of chronic respiratory segment in Brazil. And secondly, sales growth has remained strong in Mexico as well, and Glenmark is growing at about 18% value in terms of the covered market, as per IQVIA, YTD August, 2023 data. In terms of our respiratory pipeline, some key business updates for the global respiratory business, starting with Ryaltris. As of the end of second quarter of FY 2024, marketing applications for Ryaltris have been submitted in more than 70 markets. The product has been commercialized in 29 markets, including all the major markets that we alluded to earlier.
Glenmark's partner in the E.U., Menarini, intends to launch the product in other additional E.U. markets in FY 2024. Hikma, Glenmark's commercial partner in the U.S., continued to see strong prescriptions in the second quarter. And Glenmark's partner in mainland China, Grand Pharmaceuticals, has successfully completed the phase III clinical trial, with the product meeting the primary endpoint. The NDA submission to the National Medical Products Administration is targeted for December 2023. We have provided some key market shares for Ryaltris across the key geographies. In terms of other key respiratory products, the clinical trial is ongoing for the generic Flovent pMDI. We expect to file it in FY 2024, and we plan to file one more respiratory pMDI in the U.S. in FY 2025 and continue the momentum beyond that. Quick update on our innovative R&D pipeline.
So GRC 54276, which is the HPK1 inhibitor, this is a novel orally active HPK1 inhibitor that demonstrates standalone efficacy, and it enhances current immunotherapy efficacy. It is being evaluated in a first-in-human phase I study. Part 1A of the monotherapy phase is ongoing in India since July 2022. Additional subjects are being recruited in the 50 mg monotherapy backfill cohort. And the phase I, part 1B combination study with pembrolizumab and atezolizumab was initiated in India and the U.S. in the first quarter of FY 2024 and second quarter of FY 2024 respectively. And as of the second quarter, two dose cohorts have been completed, and the study is ongoing. And GRC 39815 is the company's respiratory pipeline being developed as an add-on therapy for mild to moderate COPD.
It is currently under phase I development in the U.S. Glenmark Life Sciences, external sales for GLS in the second quarter were at INR 3,900 million and $3,930 million, as against INR 3,744 million in Q2 last year, recording a YOY growth of 5%. In September 2023, Glenmark announced that it had entered into a definitive agreement with Nirma Limited to divest 75% stake in its subsidiary, Glenmark Life Sciences, at a price of 615 rupees per share for an aggregate consideration of INR 56,515 million, subject to closing adjustment. Glenmark would continue to own 7.84% in GLS after the divestment. The transaction is subject to some customary closing conditions precedent, including receipt of regulatory and shareholder approvals. For further updates, you can log on to the GLS website. A quick update on Ichnos.
Glenmark invested INR 1,613 million, which is about $19.6 million in Ichnos in the second quarter of FY 2024, compared to about $22 million in the corresponding quarter last year. For the first six months, Glenmark has invested INR 3,030 million, which is about $36.8 million US dollars, compared to about $43 million US dollars, which was invested in the previous year. Some additional notes to the results. Forex loss for the quarter was about INR 43 crore, which was recorded in other expenses. If you exclude this, the EBITDA margin for the consolidated business was at 18.8% in the second quarter.
Exceptional item in the quarter and for the half year, respectively, comprises of the US DOJ settlement related cost to the settlement and remediation costs for the manufacturing facilities in India and the US. Some key figures for the consolidated business. So R&D expenditure in second quarter was around INR 324 crores, which is 9% of the revenue from operations, and the Ichnos investment, as we noted earlier, was $19.6 million for the second quarter. Consolidated total asset addition in the quarter was INR 249.7 crores, of which tangible assets was about INR 162.8 crores and intangible assets was about INR 86.9 crores. Consolidated gross debt for the period ended September 30th was at INR 4,921 crores as against INR 4,348 crores as of March 31st, 2023.
Net debt for the period ended September 30th was at INR 3,355 crores as against INR 2,905 crores as of March 31st, 2023. Increase in net debt was mainly on account of the settlement payment for the generic litigation and payment related to the settlement agreement with the U.S. DOJ. In terms of working capital at the end of September, inventory was at INR 3,319 crores as against INR 2,978 crores at the end of March. Receivables was at INR 3,679 crores, as against INR 4,099 crores at the end of March, and payables was at INR 2,289 crores as against INR 2,392 crores at the end of March.
Given the changes in the organization, mainly, the GLS divestment, we would just like to provide some key comments on how we see the way forward for Glenmark before we start the Q&A. So the first important point is that we are expecting the GLS transaction will get recognized in Q3 FY 2024, after receiving the required regulatory and other approvals. We are considering this year as a transition year on account of the GLS divestment, which has obviously been a big event. In FY 2025, the GPL core EBITDA margins will go up by approximately 2% due to the lower R&D spend, primarily on account of the lower innovative R&D expenditure. Additionally, we are expecting further margin expansion in FY 2025 to come from Ryaltris and operating leverage kicking in across markets like Europe and Latin America.
We expect significant PAT margin growth in FY 25 mainly on account of the lower interest, depreciation, and tax expenses once we consummate the GLS transaction. With that, we can open the floor up for Q&A. I would just like to introduce the management on the call today. We have Mr. Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals, Mr. V.S. Mani, Executive Director and Global CFO, Glenmark Pharmaceuticals. So over to you, Lizanne.
Thank you. Ladies and gentlemen, we will now begin with the question-and-answer session. Anyone wishing to ask a question, may please press star and one on your touchtone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
Sir, thanks for the opportunity. So, sir, first on the bookkeeping part, like, INR 325 crore is the exceptional loss. Even if I exclude INR 30 million of that settlement payment, still the remaining amount is considerable. Is it largely to do with the remediation measures?
Yeah, I'll take that, Tushar. So obviously, one is the remediation is only about INR 26 crore in this quarter, Tushar. INR 20 crore in India and about INR 6 crore in the US. As we earlier also, we all had, sort of, you know, guided that as we go along, these costs are coming down, and it's come down in this quarter. So the balance is basically about, you know, the DOJ settlement of $30+ million and the allied legal costs that we provide with that, which will be part of that. So that is the reason why it is about INR 324 crore.
Understood. Sir, derma as a therapy in India has witnessed good slowdown. So any particular reasons to highlight here?
So I think, look, in the second quarter, right, we saw a slowdown in two of our core therapies, right? Main is respiratory, you know, the acute business. There was a slowdown in the acute business in the second quarter, which impacted our respiratory sales. And derm, there has been a slight slowdown in the second quarter. However, you know, we are seeing a strong recovery in the third quarter. So in the month of October, we grew 19%, right, as per IMS. So India business, we think, from here on, right, will come back strongly. And, I think respiratory has been a big dampener in the second quarter, which is coming back strongly in the third quarter.
I think overall, we continue to believe that India will do well, you know, this year and going forward.
Understood. Thirdly, the U.S. sales has been, you know, gradually slipping sub-$100 million now. So, when do we see, you know, this segment reviving?
So U.S., you know, second quarter was a tough quarter for us because, you know, when you think about, we had some supply disruptions because of some of the remediation work that is ongoing in the second quarter. However, in the third quarter, we think, you know, we've resolved all that and, we are back with full supply in the third quarter. Additionally, I think in the third quarter, we have almost four or five good launches. I think, the Varenicline, partnership that we did with Mankind, the product we in-licensed, we've got some good market share there. And I think we have almost three injectables getting launched in this quarter, through some partnerships. So, that coupled with some of our in-house launches.
So I think from third quarter, you should see U.S. sales come back to the original levels, right? So second quarter, we think, is an aberration.
Understood, sir. And just lastly, this upfront payment of $5 million to Cassiopea, this would happen in this third quarter? How... or how do you think about it?
Yeah, it will happen in the third quarter, yeah. But I think third quarter, again, we also have an income, you know, coming from Astria, right? You know, almost $15 million we've already received from Astria in Ichnos, right? So there is some income also in terms of.
O n the innovation side.
Understood, sir. Thanks, thanks a lot.
Thank you. The next question is from the line of Damayanti Kerai from HSBC. Please go ahead.
Hi, thank you for the opportunity. I just need some more clarity on margins. Obviously, you mentioned 2024 will be a transition year, and then, for FY 2025, you mentioned, take 200 basis points better margins on the core business part. But, for the quarter, say, if I look at the numbers, 14.4%, I'm excluding the Forex part. That is anyway, I think, looking much lower than what we had seen previously. Can you specify whether the lower performance in India and U.S. contributed majorly towards it, and maybe in third quarter and fourth quarter as India and U.S. comes back, we'll see better margins?
So Damayanti, thanks for the question. So first and foremost, obviously, you know, if you factor in the currency loss, you will come to about almost 15.7. What we are saying is that this being a transition year, going forward, we are looking at obviously, absolutely, we already guided in the past also. We look at about a 2% improvement because of, you know, reduction in the R&D costs. Plus, we also have in the initial commentary we gave that we are also looking at improvement in the margin expansion, you know, from various, from the Ryaltris as well as from across other geographies like Europe and Latam, okay? So therefore, this should significantly take our margins. So in terms of what we've been guiding in the past, we'll be closer to 19, okay? That's what we are working towards.
Even in the second half, I do agree with your point that as India and the US, you know, kicks in better, so obviously you should see it improve, okay. So I think this is the trajectory we are looking at.
Okay, so you maintain that 19% margin trajectory for your business?
Yeah, yeah. I mean, as we already alluded, that is a transition year, but we are working towards that. I mean, over the years, we have tried to improve that. Yeah.
Okay, my second question is in the U.S. business. So you mentioned some supply challenges which you have resolved now, but can you comment bit on the pricing part also? Because I guess what others or your peers have commented that prices are more or less stable. So how, how was it for your portfolio, and how do you see it for next, say, coming quarters?
The pricing environment seems to be stabilizing. However, we are still seeing, you know, standard price erosion of, roughly, you know, mid-single digit, around 5%, 5 % odd , right, across the portfolio.
Okay. And, can you also share update on Monroe regulatory part? Because earlier, if I remember correctly, you mentioned somewhere in the second half of this fiscal, we should be seeing some notable updates there.
In Monroe, we are pretty much done with most of the remediation. We are starting taking engineering batches this month followed by validation batches and commercial batches. The remediation is pretty much done. Obviously, we would have a dialogue with the FDA before resuming commercial sales, either by way of a meeting, and we are also expecting an inspection at some point.
Any like, timeline where do you expect, like, FDA can likely reinspect the facility?
It's extremely hard to predict that, but, we've started the work where we've started taking batches and, you know, both, first with engineering batches, followed by validations and then, commercial, batches.
Okay. And in terms of cost also, you mentioned INR 26 crore was the remediation cost. That was specifically for the US plant or?
No, no, that was, India was about INR 19.9 crores - INR 20 crores, and U.S. is about INR 6 crores. U.S. is much lower.
Okay. U.S., you have broadly said, okay.
Yeah, it's come off, yeah. I think, remediation, we are mostly done with everything at this point in terms of expenses, and I don't think, you know, going forward, we would have an exceptional item, as a remediation going forward.
Okay, that's helpful. Thank you very much.
Thank you. A reminder to the participants, anyone wishing to ask a question, please press star and one. The next question is from the line of Vikas Sharda from NTAsset Management . Please go ahead.
Hi, good morning. Two questions. One is that the Ichnos spend in the first half has been higher than full year run rate guided of $60 million. So how should one look at that in the second half? And secondly, this 200 basis points margin expansion next year is only from R&D, or you're building in the price increase and the operating leverage in that?
So, good morning, Vikas. Thanks for the question. So as you can see, you know, in the current year, in the first half, we have spent about $36 million, which last year was almost $43 million. So in the 36 also, we have, in the first half of the year, normally we pay out bonuses, and there are some severance costs as we are going about restructuring the, operations out there. So we still are pretty much guiding to close to 60+ is what we had said, will be thereabout. So we're not expecting that to substantially go, give and take a few million here or there. So as far as, Ichnos, that's where we are. And as you know, this year in the, third quarter, we also received $15 million on licensing out.
So those are other incomes that will keep coming in. And, as far as the margin expansion is coming, it's 2% is basically from, basically from Ichnos, that is innovation. And the balance is what we are saying, that when we say that we'll take a trajectory from where we are today, we're almost a 3%+, it's 2% is here, plus a 1%+ will come from all the, you know, margin expansion that we'll get from getting the, you know, increasing our businesses, operating leverage in Europe, LatAm. So those are the things. And what we have not specifically even called out here is that as Monroe goes live, we'll also get. Today, we have a $25 million operating costs, which is also baked into our numbers. As we go along, even that will kick in next year.
I think all in all, that's how we are trying to run the run rate closer to where we are.
Yeah, very good. One more question. How much of the Zetia payment has already been made, and how much is pending? And also, in the balance sheet, there's one item called current assets, others, which has gone up, in six months, like, by almost INR 400 crore. So what is that for?
Yeah. So good questions again. So one is obviously, we have paid more than $35 million plus for the Zetia, and also we also paid about one installment of the DOJ that came in. So these are all that went in. As far as the other current asset is concerned, because we had an input receivable going up to almost INR 190 crore. That is largely on account of, as you know, when we make these payments outside India, we have to pay GST on that, which we can take, we can take credit against that, but as of now, that money is gone, okay? So that, so that is one money that has gone.
So also, the other thing is that we have in the other current assets, PLI, which we accrued about INR 80+ crore in the current year, which we have, we have to get money from the government. I think they will plan somewhere in the second half to give us money. Also, apart from that, we also had some increase in our, you know, prepaid expense of about INR 60-70 crore, some advance payments to suppliers. So that is why it looks like a INR 400 crore jump. But I think as second half goes by, at least the input tax, some of those credits we can take and it will come off. So I think overall, with the improvement in the business in the second half also, we should see cash coming back in the business, yeah.
Perfect. Thank you very much.
Thank you. The next question is from the line of Nitin Agarwal from DAM Capital. Please go ahead.
Thanks. Manish, on the, you know, on the guidance, can you be, can you help us understand the guidance for 25 a little better in terms of what EBITDA levels are we, EBITDA margin levels are we looking at?
So as I just guided that going forward, I mean, currently, obviously this quarter we are little less than 16, but we gave a, you know, glide path, how we'll go there. We said 2% will come basically from innovation, R&D spend reduction, and 1% from the expansion in the various markets. Also, obviously, as Monroe goes live, we'll also get some benefit. I have not put that in this. So overall, based on this, we are looking at a trajectory close to 19%.
19% for FY 2025?
Yes, 19 for 25, yeah. This is a transition year, Nitin.
Right.
I think we'll have to check it as the year comes, yeah.
Which is fine. Secondly, you know, on the remediation costs, you know, what kind of positive impact do we see on account of that next year?
I don't see, I mean, as we all—you're talking of remediation costs further in the next year. Is that what you're saying?
Yeah, what I meant is, you know, because you're saying they're gonna be almost zero this year from here on, so what is the amount that you-
How much have you spent this year?
So this year, so far, I have spent about INR 77 crore, so that will not be there next year. But in any case, I'm calling it out separately. So, so that is not there next year, yeah.
That is an additional lever which is probably there for us.
Yeah, there are additional levers that are there, in terms of, yeah, profits.
Glen, on the India business now, what is, you know, how, how are you looking at India from, again, a two to three-year perspective here on?
I think, I mean, our view, Nitin, is, is our India business continues to remain very strong, right? I think between the Rx business, you know, mainly driven by, you know, the respiratory, cardiac. Cardiac is doing exceedingly well for us, derm and then diabetes, right? I mean, we are pretty much leaders in three out of the four, right? We are among the, the top two, two, three players in, in, in three out of the four segments. So India business, Rx continues to be strong. OTC, we are doing exceedingly well, so that's another growth lever going forward, which will contribute significantly to our India business. And then we have some, reasonable institution business, that's doing well in terms of hospitals and institutions, so that'll come up as a new growth lever.
I think all in all, India will do well for us. I mean, on a sustained basis, you know, we feel very comfortable with like a 12%-15% growth coming out of India, right, for the next three years.
Likewise, on the U.S., you know, while this year again is Q2, you mentioned is a soft year, things will bounce back from Q3, but with Monroe and all probably beginning to come back from next year, and I guess some of your, I mean, how do you- how should one think about U.S.? You know, there has been some improvement in the outlook, which has happened in general for other players, on the U.S. side.
So I think the US business, you know, next year will be mainly driven by some of the Monroe, you know, bringing back Monroe, some of the new launches that we have next year, right? And, I think respiratory, you know, our respiratory play will start from, hopefully from next year. We are hoping to get our first approval in the respiratory space, and then we'll keep getting approvals from there on every year. So I think, a lot of our US build-out is primarily driven by, driven by respiratory and some complex products that we're working on.
So, it's hard to predict, specifically in terms of numbers, but I mean, we have a good portfolio of products that we are filing, right? And assuming they all get approved and things are on track, right, in the years to come.
And on that, then, when are we looking to file the Flonase in here?
So the MDI, right, the Flonase, the fluticasone MDI, right? I mean, we are hoping to file around the end of this year, early next year, you know. So, between Q4 and Q1, right, we will file the fluticasone MDI.
Okay. And lastly, you know, there's been very strong growth in both ROW and in Europe. Now, how much of it is, is it largely Ryaltris driven, or there is more things which are sort of driving it?
I think Europe is more broad-based beyond Ryaltris. You know, Ryaltris is a big contributor, but we also have the four or five respiratory products that we are selling there are doing exceedingly well. I think going forward, you know, we still believe that Europe will continue to outperform, right? I mean, 15%-20% is the minimum growth trajectory that we are seeing for Europe, for our European business. ROW also is doing extremely well. We got a big approval in Brazil of salmeterol fluticasone, where we are the first, you know, it's the first generic approval salmeterol fluticasone MDI. We also have the rest of ROW, which is Asia, Latin America, Middle East, Africa, Russia, CIS. All these geographies are doing well.
Russia also, we got Ascoril LS, a big approval, which will be a big driver. And in most of these geographies, you know, they continue to do exceedingly well. So I think these are gonna be—these two geographies will be significant growth drivers for us in the years to come. You know, and of course, India continues to do well. So U.S. is a big unknown. We are doing the right things in terms of portfolio, but you know, given the uncertainties, we really struggle to put any number for the U.S. business.
Thanks. If I can squeeze the last one. On with the scale, scale-up, which you're talking about in Europe and ROW, I mean, what kind of margin, operating leverage do we see playing out in this business? I presume, I mean, and at some level, are, are these businesses, you know, below corporate level margins, or, or they are now past it?
So Europe, obviously was below corporate level till last year, right? I think this year it has, come up, closer to corporate level. And I think from next year, you can see further margin expansion coming out of Europe, right, as we go forward. ROW, you know, most geographies were almost at corporate level. Latin America was, way down, right? I mean, I think that is adding almost 3% every year from here on, right, 3%-4%, right, in terms of their EBITDA margin. So that, that itself is giving you some significant leverage coming through, right, as we go forward.
Thank you, Saldanha.
Thanks.
Thank you. The next question is on the line of Krishnendu Saha from Quantum AMC. Please go ahead.
Yeah, thanks very much, Krishnendu, and good morning. Just a little clarification, accounting clarification and with the margin put together, from my side, 25 onward, we did not have the Glenmark Life Sciences revenue, and the margins in the accounts. So just trying to put it together as to how much.
Can you please repeat? I'm not able to hear you.
We cannot hear you, Mr. Saha. Sir, your audio is not clear. Can you use the handset mode while speaking?
Yeah. Just a minute. Can you hear me now? Hello, can you hear me?
Slightly better.
Yeah.
Please proceed.
Yeah. Yeah. Just, on the accounting front with the, coupled with the margin question, just trying to understand Glenmark Life Sciences revenue, which was not, which is right now currently in the consolidated accounts, will not be there from FY 2025 onwards. So just trying to understand, what kind of contribution do they do at the, current level on a sorry, basis, say, FY 2023 onwards? And how do we... That 19% margin, does it get affected because, the, because that number is not going to be there in the consolidated accounts, if FY 2025, it still goes through?
Sorry, we are struggling to hear you. Yeah, we just can't.
Hello? Hello, can you hear me? Hello? Hello.
Mr. Saha, your voice is sounding very muffled.
Yeah, it's completely muffled. Just give me a second.
Sure, sir.
I just want... Yeah, just wondering on the accounting part.
Can maybe request that you use the handset mode and not the speakerphone.
Yeah, I'm on handset. It's, that's the problem. Yeah, just on the accounting part and on the margin part, just wondering, because Glenmark Life Sciences will not be in the numbers from FY 2025 onwards. How does the margin look? Because they do contribute quite something, something to the margins at the consolidated level. So just trying to understand that part.
So, Krishnendu, this is why we have, you know, as per accounting standard, this is how you'll see the margin today. And the earlier questions are also for the same. We have a continuing business, and we have a discontinued business. So on the continuing business, taking Forex loss, we have a current quarter profit of, I mean, EBITDA margin of about 15.7%, which we have given a clear trajectory and a, and a glide path, how we'll go to 19.2% from innovation R&D and from... Yeah.
Yeah, but I'm just wondering if it is consolidated, while it's currently consolidated, when GLS is being deconsolidated, and in effect, 25, 25, when they are not, does it not impact the EBITDA margins? Does that make any.
No, but that, so that impact is only we are absorbing, no? So I can't hear you clearly, but I'm just gathering what you're saying. It's hard to hear you out. From what I understand, you are telling that GLS margin will not be there. I agree. That is what we are making up by virtue of these measures by which we are reducing our innovation, R&D spend, and we are looking at other markets which are doing better and growing, whose margins are expected to improve. So both put together, that is how we are expecting and also with some support from as we go along with Monroe, et cetera, we're very confident we'll come closer to 19.
And I think, Krishnendu, over and above that, the key to take notice of is the PAT margins, okay? Because in next year, you will see a significant improvement in the PAT margin. So not only are we maintaining getting to the 19%+ EBITDA margin, right, but we're also expecting a significant improvement in the PAT margin compared to where we've been, right, along with GLS. So that should drive.
Yeah.
You know, the next year.
Yeah, that's, that is, that I got absolutely on, on the spot. Just, just to understand, this has nothing to do with your guidance or whatever. Just to understand, is there 100% consolidation on the PAT margin for GLS to, on the console level? Or is there something getting, something because we're not saying 100%, so how does the console... Do we have 100% of the profit of GLS in the console? That's what I'm trying to understand. That's the last question.
So the entire 100% of the EBITDA margin, all is removed of GLS. There is nothing of GLS left back in the continuing business. It's completely out. Yeah?
Yeah.
In future, whatever we buy, we buy at arm's length, okay? So there is no-
No, no, so I'm talking about historically, so if 23, 22 numbers, the numbers which are getting consolidated, do they match total the 100% of the profit of GSL into the consolidated? Is it like if they earn 100, does it reflect 100 in the EBITDA margin? Is it like that on a historic basis?
The entire margin of GLS is removed from here, okay? It's not, it's not there in the.
No, no. No, I get that. I'll get. Thank you. Thank you. Thank you.
Thank you. Ladies and gentlemen, that is the last question. I now hand the conference over to Mr. Utkarsh Gandhi for his closing comments.
Thanks, Lizanne. We'll quickly read the disclaimer before we end the call. The documents prepared and discussed during the call today, including information, statements, and analysis describing the company or its affiliates, objectives, projections or estimates, are forward-looking statements. These are based on current expectations, forecasts and assumptions and are subject to risks and uncertainties, which could cause actual outcomes to differ materially from these statements, depending upon economic conditions and other incidental factors. No representation or warranty is provided in relation to this document, and it should not be regarded by recipients as a substitute for the exercise of their judgment. The company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. With that, we can close the call. Thank you everyone for joining us today.
Thank you, members of the management team. Ladies and gentlemen, on behalf of Glenmark Pharmaceuticals Limited, that concludes this conference call. We thank you for joining us. You may now disconnect your lines. Thank you.