Glenmark Pharmaceuticals Limited (NSE: GLENMARK) Q3 2025 Earnings Call dated Feb. 17, 2025
Corporate Participants:
Utkarsh Gandhi — General Manager, Investor Relations
Glenn Saldanha — Chairman & Managing Director
V. S. Mani — Executive Director and Global Chief Financial Officer
Analysts:
Damayanti Kerai — Analyst
Nitin Agarwal — Analyst
Ashish Chaturmohta — Analyst
Kunal Randeria — Analyst
Anil Shah — Analyst
Tushar Manudhane — Analyst
Bino Pathiparampil — Analyst
Presentation:
Operator
Please wait while you are joined to the conference. The conference is now being recorded good morning, ladies and gentlemen. Welcome to the Q3 FY ’25 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 zero on the touchstone phone. Please note that this conference is being recorded. Thank you. I now hand the conference over to Mr Gandhi, Senior General Manager, Investor Relations for Glenmark Pharmaceuticals. Thank you, and over to you, sir. Thank you.
Utkarsh Gandhi — General Manager, Investor Relations
Thank you, Lizant. Good morning, everyone. Welcome to the Q3 FY ’25 results conference call for Glenmark Pharmaceuticals Limited. Before we start the Q&A, we’ll review the overall performance of the company for the 3rd-quarter of FY ’25. In Q3 FY ’25, Glenmark’s consolidated revenue from operations was at INR33,876 million as against INR25,067 million in the corresponding quarter last year, recording an overall Y-o-Y growth of 35.1%. For nine months of FY ’25, Glenmark’s consolidated revenue was at INR1,655 million as against INR87,501 million, recording a Y-o-Y growth of 15%. We’ll cover the each of the regions in a little bit more detail, starting with India. Sales from the formulation business in India for the 3rd-quarter of FY ’25 were at INR10,637 million as against INR2,658 million in the corresponding quarter last year, recording a growth of about 300%. The India business contribution in this quarter was 31.4% to the overall revenue. In terms of our overall secondary sales, Glenmark continues to outperform the Indian pharmaceutical market in terms of Y-o-Y growth. As per IQVIA, Glenmark India Formulation business recorded a growth of 9.6% in Q3 — in Q3 of FY ’25 and 12.3% as per MAT December 2024 compared to the overall market growth of 7.2% in Q3 and 7.4% in MAT, respectively. Glenmar continued to perform well in its overall — in its key therapeutic areas, particularly in dermatology and cardiac. Our Glenmark India business is now ranked 13 with a market-share of 2.23% as per IQVIA MAT December 2024 data. The company added one brand to the IPM top 300. So we now have 10 brands in the IPM top 300 brands. And in terms of our key therapeutic areas, we are ranked second in dermatology, third in respiratory and fifth in the cardiac segment as per the IQVIA MAT December data. Obviously, we have improved our market-share in some of these key therapeutic areas as well. Some of which has been provided in the MD&A. We have some key launches in the last few quarters in our key therapeutic areas, products like Lirafit, which we launched as the first biosimilar of leraglutide. It has seen good traction in the market post-launch. We are also planning to launch other GLP-1 agonists in the near-future. And in the dermatology segment, we launched Jabris, which is abrocitinib. This is in partnership with Pfizer. It’s oral systemic treatment for to severe atopic dermatitis. And again, this product has also been received well by dermatologists. We also have two oncology products which we had partnered with Beijing, and. They will be responsible for locally required development, registration and distribution of these products in India. And Glenmark plans to launch these products over the next three to four months once we receive the required regulatory approvals. In terms of our consumer care business in India, primary sales for the GCC business in Q3 was INR566 million with a Y-o-Y growth of 13%. The company’s flagship brand Candid Powder gained market-share as per IQVIA data and our brand market-share now is at 55%. In the 3rd-quarter, the scalp portfolio also delivered robust growth as well as La Shield, which delivered growth of 13.5% as per IQVIA MAD December data. Moving on to North-America. The North-America business recorded revenue in Q3 of INR7,813 million for the 3rd-quarter as against INR7,705 million for the 3rd-quarter of FY ’24, which translates into a Y-o-Y growth of 1.4%. For the 3rd-quarter of FY ’25, North-America business contribution was at 23.1%. The US business continued to remain challenging due to lack of meaningful launches during the quarter. However, the company expects an uptick in the business, particularly from FY ’26 onwards on the back of potential launches in the respiratory and injectable segments. Glenmark expects to launch some of its respiratory ANDAs from H1 — FY ’26 onwards and the company continues to augment its commercial portfolio in the meantime through partner product launches to help the business growth in the near-term. In the 3rd-quarter of FY ’25, Glenmark launched Trave ophthalmic solution and oral solution. We filed one ANDA during the quarter and plan to file one more NDA in the upcoming quarter. We have eight commercial products in the — eight commercial injectable products in the US market. And we have also leveraged a strong development skills in the respiratory area. Glenmark has filed two NDAs for generic nasal space and is awaiting approval for the same. As well as we mentioned earlier that we have filed the NDA for generic 44 MCG MDI in May 2024. Glenmark is also working on filing the other ANDAs for the other two strengths of as well as other respiratory products, which are currently in the pipeline. Our Glenmark marketing portfolio through December 31 December 2024 consists of 201 generic products authorized for distribution in the US. The company has 51 applications pending at various stages of in the approval process, along which of which 22 are four applications. Moving on to Europe, Lenmark’s Europe operations revenue for the 3rd-quarter of FY ’25 was at INR7,297 million as against INR6,357 million, recording a Y-o-Y growth of 14.8%. Europe business contributed 21.5% to the total revenues in the 3rd-quarter of FY ’25. The branded business in Europe — in Glenmark’s European operations continued its trajectory driven by sustained growth across all key markets. Our overall CE region did face some challenges due to seasonality. However, Ryaltris particularly has done really well. It continues to gain market-share across the countries where the product has been launched and branded respiratory portfolio in the Western European business also has sustained its growth momentum with key brands like Ryaltris, Almex continuing to sustain and gain their market-share in terms of value and volume. Glenmark is now ranked 13th in the generic market of Germany as per the IQVIA data. Going-forward, we continue to focus on sustaining the increased contribution from branded products and branded markets in Europe. Glenmark is awaiting approval of four respiratory products which were filed in Q4 FY ’23 and recently, the company announced that it has received approval from the MHRA to-market Winlevi in the UK and the company is planning to launch in the UK as well as the select markets of Europe in FY ’26. Moving on to the ROW region, which consists of Russia, CIS, Latin-America, Mia, Mia region and the Asia-Pacific countries. For the 3rd-quarter of FY ’25, revenue from the ROW region was INR7,491 million as against INR7,271 million for the corresponding quarter last year, recording a Y-o-Y growth of 3%. For the 3rd-quarter of FY ’25, the ROW business contributed 22% — 22.1% of the overall sales. The reported growth for the ROW region during the quarter was impacted due to the adverse currency movements in some of the key markets. As per IQVIA MAT December data, Lenmark’s Russia business recorded secondary sales growth of 16.6%. Royalty sustained its momentum and gained further share during the quarter in the Russian market. In dermatology, Glenmark demonstrated strong growth of 20 plus in value versus overall retail market growth of around 16% as per the IQVIA data. Glenmark continues to be ranked ninth amongst the dermatology companies in Russia as well as second amongst the companies present in the respiratory expect market in the Russian country. For Latin-America, the respiratory portfolio continues to be a key growth driver. Glenmark launched the first-in India in the Brazilian market in Q1, the product has done well post-launch. The company also received approval for,, DPI in Mexico and was also launched in Mexican market in Q2 and since has gained share in that country. In the Middle-East, Africa region, the continue — the company continues to achieve good secondary sales growth in key markets. Continues to be ranked second in Kenya and Ryaltris, which is a major product in the South African market continues to be the leading nasal spray for allergic rhinitis there. In the Asia region, key markets like Malaysia and Sri Lanka recorded double-digit growth. Continued to drive the — again, the significant outperformance in the Australian market. And we have some new product launches in dermatology and respiratory, which will contribute to growth in the upcoming quarters. Quickly covering some of our key global brands. So we talked about Ryaltris as of December ’24, marketing applications for Altris have been submitted in more than 90 countries and the product has been commercialized in 43 markets. Further, we expect to launch in another 12 to 15 additional markets over the next few quarters. As per the IQVIA data, we have — has seen some robust performance in terms of value and unit market shares, particularly in some of the markets we covered during the earlier part of the commentary. Glenmark’s commercial partners in the US, recorded decent performance on a Y-o-Y basis in the 3rd-quarter. Many Glenmark’s partner in the European region has also witnessed steady increase in-market share across its licensed markets. The product also does well in the South Korean market where Yuan, our partner is marketing on our behalf. And Glenmark’s partner in Mainland China, Grand Pharmaceuticals expects to receive the product approval sometime in FY ’26. So moving on to enrofilimab, we had announced earlier in Jan 2024, the signing of a licensing agreement with Yangsu, Alzumab and for almofilimab for India and the ROW regions. Our envofilimab is already marketed in China. It has already been included in the list of therapies by the Chinese regulatory agency. And envofilimab is along with its key indication of being a PDL1 for treatment of adult patients with previously treated MSI-high biomarker, is also being investigated in clinical trials for additional oncology indications like non-small cell lung cancer. Clenmar plans to file in more than 20 markets in the current year and the first market launch is expected in FY ’26., in Q2, we announced the licensing of Winlevi with Cosmo, but as mentioned earlier, the company recently-announced the approval from MHR in the UK and we are planning to launch in FY ’26 in some of our licensed markets. Lastly, covering IGI, IGI and Glenmark innovation which features a robust pipeline of three innovative oncology molecules targeting multiple myeloma, AML and some solid tumors. Two of the molecules have received orphan drug designation. In addition, IGI also has two autoimmune disease assets that have been out-licensed to companies which ILB80, which has been out-licensed to Almiral and ISB 830, which has been out-licensed to Therapeutics. In terms of ILB 2001 this is a tri-specific antibody for oncology and immunology. It is a BCMA, CD3, CD38 tispecific T-Cell engager that targets all the three biomarkers and to harness the body’s immune system against cancers. It is amongst the first eyespecific antibodies developed for use in multiple myeloma. It received often drug designation in July 2023 from the USFDA. The Phase-1 trial — first-in human trial for relaxed refractory multiple myeloma was initiated in November ’23. That’s when the first patient was dosed. The trial is now active across centers in the US, Australia and India. Dose-escalation is currently underway. And in December ’24, we announced first time data presentation at the American Society of Hematology Conference in San Diego. The oral presentation was circulated to the investors as well and detailed out the dose-escalation part of the study. ILV 2001 has shown a very favorable safety profile with a very strong efficacy, overall response rate of 83% and along with 22% complete response or better and 50% very good partial response. And the overall response rate was 75% in-patients who treated with CAR-T or bispecific T-cell engagers and 16 80% of our patients remain on the treatment at the time of the data cutoff. IVA has initiated partnering discussions post the ASH conference and the company aims to conclude a partnership in calendar year 2025. Further data from the Phase-1 dose-escalation study will also be presented at the American Society of Clinical Oncology ASCO conference in June 2025. Before we start the Q&A, just a quick update on the notes to the results. Our ForEx gain in this quarter was INR23 crores, which was recorded in other income. R&D expenditure in Q3 was around INR225 crores, roughly 6.6% of sales for Q3. Our investment in IGI was USD13.8 million. The total addition — asset addition to the block during the quarter was INR143 crores, of which tangible asset addition was around INR72 crores and intangible asset addition was around INR71 crores. In terms of working capital at the end of December ’24, inventory was at INR3,090 crores. Receivables was at INR2,914 crores and payables was at INR2,212 crores. Net-debt for the period ended December ’24 was at INR109 crores. We have the management of Glenmark Pharmaceuticals on the call today, Mr Glen Saldana, Chairman and Managing Director; Mr VS, Executive Director and Global Chief Financial Officer; and Mr Ashish, Group Vice-President and Head of Corporate Strategy. With that, we can open the call for Q&A.
Questions and Answers:
Utkarsh Gandhi
Over to you, Lizan. 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 in one on your touchstone telephone. If you wish to yourself in the question queue, you may press star and two participants requested to use handsets while asking a question. Ladies and gentlemen, we will wait for the moment while the question queue assembles. The first question is from the line of Karai from HSBC. Please go-ahead.
Damayanti Kerai
Hi, thank you for the opportunity. My first question on India business. So in some of the key therapies, you have definitely grown much better than the market. But just want to check your diabetes profile seems — the good profile for diabetes seems weaker than the market. So can you explain what is happening there and how should we look at this point?
Glenn Saldanha
Sure. So let me — let me just talk about the entire India business, right, and then I’ll come specifically to your question on diabetes, right? So if I look at our India business, right, we started the year-by guiding to around INR1,100 crores per quarter, which is about a 9%, 10% growth, right? If I look at the first-half, we did exceedingly well. We outperformed those numbers, right? And Q3, we’ve seen some slowdown in the respiratory space, but I think on a full-year basis, right, we are pretty confident that we’ll be able to meet our guidance, right, or for the India business. If I look at specifically each of the segments, you know, cardiovascular dermatology continue to do exceedingly well. Respiratory — acute respiratory, we’ve seen some slowdown, although we are growing faster in the chronic area. And diabetes, we’ve had some challenges in terms of stock levels for leader fit, but every month we’re getting better in terms of the supply of leader fit. So I think leader fit once come — once we come into full supply, which should be in the month of — in this month or next month-in this quarter, then you’ll see the diabetes growth coming back, right. The other thing to keep a watch out for is obviously once the GLP ones — this is the first GLP one, but once the subsequent assets come to-market, that will further enhance our diabetes sales. So across the four therapeutic areas that we operate in India and of course, oncology, we are looking at a good FY ’26 primarily because of the Beijing products, and zanobrutinib, which should contribute pretty significantly to the oncology business in India. So these five segments will continue to do well for the company going-forward?
Damayanti Kerai
Thanks, Glenn. But the stock level problem which you mentioned for Lira, it’s like specific to that particular product and in other part of the portfolio, how is the performance? Because market has grown, right, but you seem to be in —
Glenn Saldanha
So in diabetes, we’ve traditionally had two molecules,, right, with the new and teneligliptin with the new DPP 4s and GLTs that have come into play, right? We’ve lost some share on both these molecules. But some of it has been offset with the launch of and Lira Fit continues to do well. So I think across-the-board, the segment continues to do well and will continue to grow every year from here on.
Damayanti Kerai
Okay, got it. My second question is on your US business. So again, if you can share the status of Mondu plant because I guess we have been waiting for like quarter-after-quarter, but if you can share the latest status, that could be helpful.
Glenn Saldanha
So let me start with just giving a broad overview on the US business, right, before I go to Monroe. So if I look at the US business, right? I mean, every quarter things are getting better. I mean, I think Q4 we have some interest — found some good launches, which will ensure that we have Q-on-Q growth in the 4th-quarter. If I look out to FY ’26, we have two major launches in the first-half of FY ’26. One is of course, 44 MDI, right, Flonase, where we believe we have an exclusive position. We also have nasal spray, right, getting launched in first-half of FY ’26. Both these are very big products. So should contribute pretty significantly to the growth. In addition, we have the other strengths of MDI getting filed in FY ’26 and one other respiratory MDI product getting filed in FY ’26. I mean, all this put together, right, in FY ’27, if you see market potential of this entire franchise, right, the filings and the launches we are doing this year, you’re looking at almost $600 million, $700 million of franchise coming to-market in FY ’27. In addition, you know, we have the three — we have three sole 180-day exclusivities/180-day coming up in FY ’27 and ’28, which is another $800 million market. So I mean, the next two, three years, FY ’26, ’27 and ’28 should be strong years for the US business. Now with that backdrop, Monro, we are still waiting for the FDA to come in and inspect us at Monroe, but we continue to take batches and we continue to file some of our products out of Monroe. So — so — and these are mostly injectables, complex injectables. So I think longer-term, given the geopolitical situation, I mean, we think should have a significant benefit, right as we go-forward. So it’s only a matter of time. We think Monro should payback and start playing out as we go-forward.
Damayanti Kerai
Sure. And when did you have — had your last communication with the FDA regarding Monro plant?
Glenn Saldanha
Yeah. So we did a meeting with them. I think it was a couple of months ago. And since then we give — we send in constant updates to them on the status — on the status of our remediation.
Damayanti Kerai
Okay. Okay, Glen. That’s very helpful.
Glenn Saldanha
Thank you.
Operator
Thank you. A reminder to the participants, anyone wishing to ask a question may please press star in one if you wish to ask a question, you may please press star in one the next question is from the line of Nitin Agarwal from DAM Capital. Please go-ahead.
Nitin Agarwal
Hi, thanks for taking my question. Glen, on ISP 2001, is there any more update post the ASH data that you presented? And how should we look at this asset now going-forward?
Glenn Saldanha
So clearly ISB 2001 is a super exciting product, right, and has the ability to be a transformational asset for — for Glenmark and probably the entire multiple myeloma space, right, given the data we put out at ASH and subsequent to that, we’ve opened partnering discussions. So we were at — at JPM, we did a number of meetings with a lot of companies and there is tremendous amount of excitement about the potential of this asset. So we are clearly on course to finding a partner to drive ISB 2001. So I mean, we’ve given ourselves till the end of this year, but it could be earlier, but there is a tremendous amount of interest in the asset from a partnering perspective all these blended trial — and the trial continues. I mean we continue dosing patients, we are hoping to start the dose expose expansion cohort in the next three to six months. So I think that process continues. So we’ll have a significant number of patients before the end of this year. We’ll have an update at ASCO on ISB 2001. So the rest of the process continues.
Nitin Agarwal
And from a — from a partnering perspective, Glenn, are there any specific data points which — which are data points that incrementally that you are awaiting or how should — what I’m saying, so is there any trigger or anything, any milestone that will probably enable or accelerate the whole licensing part. I mean what will take licensing to go through and not go through from here?
Glenn Saldanha
So we don’t think that we are waiting on anything as of now, Nitin. So it’s only a — I think it’s all procedural from here, right? So we just opened discussions in Jan so it’s going through the process, right,
Nitin Agarwal
The data that you’ve got so-far is enough for us to conclude the deal?
Glenn Saldanha
Yes, it is.
Nitin Agarwal
Okay. So how should one think about now depending upon when the licensing happens on the R&D spend for us going-forward?
Glenn Saldanha
Or our view is FY ’26 will be the last year where Glenmark will have to put capital into IGI. I mean IGI, given the partnering interest that we are seeing and the excitement around the asset, we are pretty confident that we’ll be able to close a deal which will fund IGI going-forward. And then, of course, the long-term goal for IGI is then to IPO the company in the US. So that’s the journey for IGF. So we believe F ’26 will be the last year of investment into IGI from Glenmark.
Nitin Agarwal
Thanks. And secondly on the balance sheet, there has been this buildup of net working capital again. I think we are little away from what we guided to at the start of the year for the — for FY ’25. So any thoughts on that? Where should we end the year at? And what is driving this increase right now?
V. S. Mani
Yeah, sure. So,, we had already — I mean, in the beginning of the year, we did sort of guide that the working capital will go up and some of the working capital items are pretty much close to what the industry levels have. In this quarter, obviously, there is some increase in the inventory based on the — we already read-out the numbers. So we had to buy some — as you know, we had also earlier discussed about some critical launches coming up in the next couple of quarters. So we had to build-up some inventory for that. So Nitin, I expect it to sort of normalize in the coming quarter and the first-quarter. So I think broadly that will help us to sort of improve our working capital.
Nitin Agarwal
And sir, if you could remind us what working capital day should we work with as a sustainable number?
V. S. Mani
So we are — so maybe last quarter we were at about 90 plus. So I think those are the levels at which I would expect to be there. Yeah.
Nitin Agarwal
Okay. And sir, and then lastly on — you mentioned about MDI what when are we looking at an approval, what’s your assessment on when the approval? What is sort of when does approval come through for that for the first time.
Glenn Saldanha
So we’ve given ourselves till H1 Nitin, it could be earlier in the right, but H1 is when we anticipate first-half of next year, right, 44 will get up to
Nitin Agarwal
Okay. And last one on the Glen for the guidance for the year, actually tracking a little below on the EBITDA number, EBITDA percentage number that we had — that we had earlier.
V. S. Mani
I’ll take that Nitin. So obviously, we are almost at about 18% for the nine months so-far. And as we had already sort of given during our commentary that we had some currency hit during the 3rd-quarter especially. If we adjust for that, we would be close to 19%. So we almost had about INR71 crores coming out of some of the emerging markets in LatAm and also in South Africa, et-cetera and Russia as well. So I think if you were to take for that, we should be close to what we guided in the beginning of the year. Also, our turnover is also at about INR10,000 plus crores. So Q4 is generally a good quarter. So we should close — we should close to be about INR3,500 crores. So I think broadly, we would be able to meet the numbers that we gave you and barring is for some of the currency.
Glenn Saldanha
So on the full-year, we will hit both the — our top-line as well as EBITDA guidance, right, adjusted for currency.
Nitin Agarwal
And if I can take one last one, sir, on the overhead, staff costs, other expenses, there has been a reasonable control, which has come through in the first-nine months in terms of Y-o-Y growth. I mean, do we expect — I mean these are now more sort of sustainable trends on these overhead increases?
V. S. Mani
Yeah, absolutely. So as I told you, even in the last quarter, it’s slightly the other expense picked-up. But I did tell you that full-year we would be about 27% and broadly we are there only. We are not going to exceed that. And obviously, expenses don’t happen and sometimes a little bit comes here and there in terms of how you want to do sales marketing, but I pretty much see it where it is.
Nitin Agarwal
Thank you so much.
Operator
Thank you. The next question is from the line of Ashish from JM Mutual Fund. Please go-ahead.
Ashish Chaturmohta
Yeah. Thanks for the opportunity. Sir, any update on and injectable segments for the US market, especially you guys are there on-the-ground. Any update regarding the tariff discussions possibly in the US market?
Glenn Saldanha
So respiratory, I have pretty much given you the roadmap, right? Between the three, flutigazone, 44, 110 and 220 put together is almost 500 million in addition, you have nasal spray, which can be a substantial product and we have one more respiratory MDI filing this year, which is another $200 million product. So I think we are on a good track to get these five or six key respiratory launches, right, over the next few years. On the injectable side, Monroe, we are continuing to file products, we are continuing to take batches and we have some exciting filings going out this year and next year out of Monroe. We are just waiting for the FDA — for the FDA to come in and audit us in the interim. So these two segments, we continue to move forward nicely as a company. We also in the near-term, especially in Q4, you should see some good in-licensing products coming to-market. In we have some good launches coming up in Feb and in March, which should help this quarter partially, but help the next quarter in a significant manner. So I think all-in all looks pretty good. As far as the tariffs go, it’s extremely hard to predict for anyone. What we’ve heard is that some of these are getting postponed, but it’s extremely hard to predict how this will all play-out in the long-run.
Ashish Chaturmohta
Fair enough. And any update on the entire GLP-1 category you did mention about one of the biosimilar launches. But going-forward from a two to three years perspective as and when the GLP market in India opens up, how are we positioned? And yeah, any update on — will be very helpful.
Glenn Saldanha
So Lira, so in the GLP-1,, Lira Fit, Glenmark was the first to launch the GLP-1 in India, right, injectable GLP-1 and we are well-positioned to also launch semaglutide injectable and eventually overall also. So I think it — although I think it will be a crowded market, I think we are well-positioned to launch the products in India.
Ashish Chaturmohta
So and how about in terms of integration, obviously, like we might be sourcing the drug substance and other products, other field finish opportunities from the other parties. But in terms of the MR, the field force, our front-end or would we have to deploy incremental capital or resources?
Glenn Saldanha
Yeah. We already — at Genmark, we already have a strong diabetes franchise, right? So we won’t need any additional resources. So we have all the necessary capabilities to commercialize these products
Ashish Chaturmohta
. Fair enough. Sir, lastly, obviously, adjusted for currency, you did mention that 18%, 19% EBITDA margin run-rate that we are already clocking. But going into FY ’26, with India coming back, US also lot many launches coming into picture. Any guidance on EBITDA margins you would like to give?
V. S. Mani
Yeah. So if you recollect even during our investor presentation, we had said that year-on-ar we expect 1% to 1.5% improvement. So I think things go well, we should definitely. And with these critical launches that we expect to come through, we expect to be improving by a percentage and a percentage half.
Ashish Chaturmohta
Fair enough. Thanks and all the best.
Operator
Thank you. The next question is from the line of Kunal Randeria from Axis Capital. Please go-ahead.
Kunal Randeria
Yeah, hi, good morning. Glenn, I heard your commentary on domestic business, but I’m afraid I’m not fully.
Operator
Kunal, can you speak a bit louder? We’re not able to hear you.
Kunal Randeria
Yeah, sure. I hope that’s better. Glenn, yeah, I heard your commenting on the domestic business, but I’m not completely sure I fully understand this. See, the IQVI growth was around 9.5% for Q3, while your reported growth, I mean, reported would be on a decline, I guess, right, on a year-on-year basis. So why such a big delta? And even after I were to assume that primary sales were higher in H1, that still does not explain such a big delta. So if you can just.
Glenn Saldanha
Yes. So Kunal, as I said, look, we had guided to INR1,100 crores in the beginning of the year, right, which is a 9%, 10% growth. If you see the nine months, we are at 6.3% growth, okay? Yes, Q3 was a soft quarter for us, right, and we discussed it primarily because of acute respiratory, which is a big part of Glenmark’s portfolio, okay, right? And we had a very good H1, right? So I think you know, we will meet our guidance, right, of 9% to 10% and the INR1,100 crores per quarter on an average, right, that we’ve guided towards.
Kunal Randeria
But then how would 4Q pan-out because if I were to assume you’d be around INR4,400 crore for the last — for the full-year. Last quarter would be what around INR900, I guess, right, which would be what flat to slight declining?
Glenn Saldanha
No, it could be better than that. Look, this is what we guided at the beginning of the year, right, Kunal, that’s the way to think about it, right? We could definitely be better than that. We will be better than that.
Kunal Randeria
Sure, sure. Okay. Got it. Secondly on Indore plant, just can you talk a bit more about the observations and how critical this plant is in terms of revenue contribution and outstanding filings.
Glenn Saldanha
Sure. So I think you know the Indore plant got audited after six years, right? That’s a you know it’s been a long-time since we got audited. We had a very thorough inspection from the agency. There were no DI observations and we’re pretty confident we’ll be able to address the observations. So I think from a — from a revenue perspective, it probably around 25% or 25% to 30% of total US revenues comes from there from that facility.
Kunal Randeria
Sure. And in terms of outstanding findings.
Glenn Saldanha
We have probably about four or five outstanding filings, but none of the products I mentioned are coming from Indore.
Utkarsh Gandhi
So it’s more of a base OSD portfolio that’s essentially filed from Indore. So we have some four, five odd pending filings from there in the more near-term. But none of the respiratory products or the injectable ones are coming out of Indo.
Kunal Randeria
Your injectables one would be from Nagpur, right?
Utkarsh Gandhi
Injectable is from from.
Kunal Randeria
Okay, got it. Got it. Thank you and all the best,
Operator
Yeah. Thank you. The next question is from the line of Anil Shah from Insightful Investments. Please go-ahead.
Anil Shah
No, most of my questions have been answered. Thank you so much.
Operator
Thank you. Thank you, sir. Thank you. The next question is from the line of Tushar from Motilal Oswal Financial Services. Please go-ahead. Pushar, your line is in the talk mode. Please go-ahead.
Tushar Manudhane
Hi, am I audible?
Operator
Yes, sir. Please proceed.
Tushar Manudhane
Yeah. Sir, just with respect to generic flow end just want to understand if we have additional query here.
Glenn Saldanha
No, we’ve responded to all the — all the deficiencies from the agency and we are we waiting for them to respond.
Tushar Manudhane
So I mean, has this happened recently and that’s the reason why the approval is sort of indicated in first-half FY ’26? I can’t give more visibility than that. We’ve responded to everything. We’re just waiting on the agency to for the approval. So secondly, on this three products which you highlighted about FDF FTF 180 day exclusivity, where are we in terms of sort of filing approval cycle for these products?
Glenn Saldanha
So to the best of my knowledge all the three are tentatively approved and are ready to get launched.
Tushar Manudhane
Okay. So more of the — so there is no litigation angle to these products.
Glenn Saldanha
Now they’ve all been settled.
Tushar Manudhane
Thank you. That’s it for thank you.
Operator
Before we take the next question, we would like to remind participants that you may press star and want to ask a question. The next question is from the line of Dinov Patiparampal from Elara Capital. Please go-ahead.
Bino Pathiparampil
Hi, good morning, everyone. Just a follow-up from the previous question. There is this product axitinib or brand-name in which you have a tentative approval and I believe you are one of the first-to-files. Are you the first-to-file? And is that an launch we can expect in the next one or three years?
Glenn Saldanha
I cannot comment on the status of but clearly we will you know, you will see us launching this product as we go-forward.
Bino Pathiparampil
In the next 12 to 24 months or beyond tha
Glenn Saldanha
T I can’t give you any visibility around that.
Operator
Thank you. Thank you. A reminder to the participants, anyone wishing to ask a question may please press star in one. The next question is from the line of Nitin Agarwal from DAM Capital. Please go-ahead.
Nitin Agarwal
Thanks for taking my follow-up. Glenn on the respiratory business, barring the set of filings you’ve talked about for this year, both on the — I mean, can you give us more color on how is the — is there anything more from a pipeline perspective in respe for the US?
Glenn Saldanha
Nitin, we are constantly working on respiratory being a focus area for us, right? I think our current focus is even if we can get these products approved, Nitin, I mean, you can imagine the kind of sales potential, right, between the three strengths of Flow end, right, $500 million market, the one extra MDI we are filing this year, another $200 million and the nasal sprays put together. So you’re looking at a very large market potential. So I think even if we are able to get all these approved, the next three years should look very strong on the respiratory side for us.
Nitin Agarwal
Which I entirely get. I’m just curious, is there more beyond this or because
Glenn Saldanha
Of course, we are working with on the next set of products, right? But I mean, right now, we can’t give any visibility.
Utkarsh Gandhi
More near-term opportunities, obviously we have outlined here.
Nitin Agarwal
And secondly, if you can just give us a little more color on how Ryaltris is sharing, any sense on the size it has got to, I mean what size are you extending for the year-on this?
Glenn Saldanha
Yeah. So Ryaltris, this year, we will be close to about $80 million, right, second year of launch, right? We’re already tracking last quarter was almost $19 million $20 million of sales. So almost $80 million product for us and we still — next year, we still have some major markets to launch next year and the year-after that like Brazil, China and many more smaller markets where we are still waiting to launch the product. So I think over-time, we are pretty much on-track to achieving $200 million, $300 million of sales — peak sales over-time.
Nitin Agarwal
And from an accounting perspective, because I presume a lot of — is there a large proportion of the $80 million which is coming in form of your royalties or profit share? How should one think about that number?
V. S. Mani
Sorry, come again.
Nitin Agarwal
I mean, is there a $80 million on royalties that we’re booking? Is it a large chunk of it coming in from a profit share which has a lot of more flow-through to the EBITDA, almost not the case. It’s quite stable.
V. S. Mani
I don’t think there is any royalty only because there is no major royalty in that. It’s all sale of — I mean, we have what we have sold to partners or what we are selling directly. A lot of markets, as you know, we have put our own field force. We have almost launched it now in 43 countries in the same. So it’s not a question of. So there’s no major any royalty or anything in this.
Nitin Agarwal
So what I really meant is, is there a much higher-margin business overall for us than the — as a product, then we better margin product with them.
V. S. Mani
It’s — because in a lot of geographies you launch it ourselves, so that’s how it works.
Nitin Agarwal
Okay. Thank you so much.
Operator
Thank you. A reminder to the participants, anyone wishing to ask a question may please press star in one. As there are no further questions, I now hand the conference over to Mr for his closing comments.
Utkarsh Gandhi
Thanks, Lizan. Before we end the call, you would just like to state that the discussion materials provided during today’s call, including the information, statements and analysis made by the company or its affiliates, affiliates objectives, projections and estimates of forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties and actual outcomes could differ materially from these statements depending on the economic conditions, government policies and other factors. No representation of warranty either expressed or implied is provided in relation to the discussion in the documents and it should not be used as a — by recipients as a substitute for their excess of their own 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 end today’s earnings call. Thank you for joining us.