Good morning, ladies and gentlemen. Welcome to the Q3 FY 2025 Earnings Conference Call Of Glenmark Pharmaceuticals Limited. As a reminder, all participant lines will be in the listen-only mode, and there will be no 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 touch-tone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Utkarsh Gandhi, Senior General Manager Investor Relations for Glenmark Pharmaceuticals. Thank you, and over to you, sir.
Thank you, Lizanne. Good morning, everyone. Welcome to the Q3 FY 2025 results conference call for Glenmark Pharmaceuticals Limited. Before we start the Q&A, we'll review the overall performance of the company for the third quarter of FY 2025. In Q3 FY 2025, Glenmark's consolidated revenue from operations was at INR 33,876 million, as against INR 25,067 million in the corresponding quarter last year, recording an overall YoY growth of 35.1%. For nine months of FY 2025, Glenmark's consolidated revenue was at INR 101,655 million, as against INR 87,501 million, recording a YoY growth of 15%. We'll cover each of the regions in a little bit more detail, starting with India. Sales from the formulation business in India for the third quarter of FY 2025 were at INR 10,637 million, as against INR 2,658 million in the corresponding quarter last year, recording a growth of about 300%. The India business contribution in this quarter was 31.4% of the overall revenue.
In terms of our overall secondary sales, Glenmark continues to outperform the Indian pharmaceutical market in terms of YoY growth. As per IQVIA, Glenmark's India formulation business recorded a growth of 9.6% in Q3 of FY 2025 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. Glenmark continued to perform well in its key therapeutic areas, particularly in dermatology and cardiac. Glenmark's India business is now ranked 13th 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. 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 have been provided in the MD&A. We had some key launches in the last few quarters in our key therapeutic areas, products like Lirafit, which we launched as the first biosimilar of liraglutide. 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 Jabryus, which is abrocitinib. This is in partnership with Pfizer. It's an oral systemic treatment for moderate 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 BeiGene, Tislelizumab, and Zanubrutinib. We'll be responsible for locally required development, registration, and distribution of these products in India.
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 INR 566 million with a YoY growth of 13%. The company's flagship brand, Candid Powder, gained market share as per IQVIA data, and brand market share now is at 55%. In the third quarter, the Scalpe portfolio also delivered robust growth, as well as La Shield, which delivered growth of 13.5% as per IQVIA MAT December data. Moving on to North America, the North America business recorded revenue in Q3 of INR 7,813 million for the third quarter, as against INR 7,705 million for the third quarter of FY 2024, which translates into a YoY growth of 1.4%. For the third quarter of FY 2025, North America business contribution was at 23.1%.
The Glenmark U.S. business continues to remain challenging due to lack of meaningful launches during the quarter. However, the company expects an uptick in the business, particularly from FY 2026 onwards, on the back of potential launches in the respiratory and injectable segments. Glenmark expects to launch some of its respiratory ANDAs from FY 2026 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 third quarter of FY 25, Glenmark launched Travoprost Ophthalmic Solution and the Lacosamide Oral Solution. We filed one ANDA during the quarter and plan to file one more ANDA in the upcoming quarter. We have eight commercial injectable products in the U.S. market. We have also leveraged our strong development skills in the respiratory area.
Glenmark has filed two ANDAs for generic nasal sprays and is awaiting approval for the same. As well as we mentioned earlier that we have filed the ANDA for generic Flovent 44 mcg MDI in May 2024. Glenmark is also working on filing the other ANDAs for the other two strengths of Flovent, as well as other respiratory products which are currently in the pipeline. Glenmark's marketing portfolio through December 31st, 2024, consists of 201 generic products authorized for distribution in the U.S. The company has 51 applications pending at various stages in the approval process, of which 22 are for applications. Moving on to Europe, Glenmark's Europe operations revenue for the third quarter of FY 2025 was at INR 7,297 million, as against INR 6,357 million, recording a YoY growth of 14.8%. Europe business contributed 21.5% to the total revenues in the third quarter of FY 2025.
The branded business in Europe, Glenmark's European operations, continued its trajectory driven by sustained growth across all key markets. Overall, the EU region did face some challenges due to seasonality. However, Ryaltris, particularly has done really well, continues to gain market share across the countries where the product has been launched, and the branded respiratory portfolio in the Western European business also has sustained its growth momentum, with key brands like Ryaltris, Salmex continuing to sustain and gain the 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 2023.
Recently, the company announced that it has received approval from the MHRA to market Winlevi in the U.K. The company is planning to launch in the U.K. as well as the select markets of Europe in FY 26. Moving on to the ROW region, which consists of Russia CIS, Latin America, MEA region, and the Asia-Pacific countries. For the third quarter of FY 2005, revenue from the ROW region was INR 7,491 million, as against INR 7,271 million for the corresponding quarter last year, recording a YoY growth of 3%. For the third quarter of FY 2025, the ROW business contributed 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, Glenmark's Russia business recorded secondary sales growth of 16.6%.
Ryaltris sustained its momentum and gained further share during the quarter in the Russian market. In dermatology, Glenmark demonstrated strong growth of 20+% in value versus the 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 expectorant market in the Russian country. For Latin America, the respiratory portfolio continued to be a key growth driver. Glenmark launched the first salmeterol fluticasone MDI in the Brazilian market in Q1. The product has done well post-launch. The company also received approval for salmeterol fluticasone DPI in Mexico, and Ryaltris was also launched in the Mexican market in Q2 and since has gained share in that country. In the Middle East and Africa region, the company continues to achieve good secondary sales growth in key markets.
Glenmark 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. Ryaltris continued to drive, 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 Ryaltris have been submitted in more than 90 countries, and the product has been commercialized in 43 markets. Further, we expect to launch in another 12-15 additional markets over the next few quarters.
As per the IQVIA data, Ryaltris has seen 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 U.S., Hikma, recorded decent performance on a YoY basis in the third quarter. Menarini, Glenmark's partner in the European region, has also witnessed a steady increase in market share across its licensed markets. The product also does well in the South Korean market, where Yuhan Corporation, 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 2026, so moving on to Envafolimab, we had announced earlier in January 2024 the signing of a licensing agreement with Jiangsu Alphamab and 3D Medicines for Envafolimab for India and the ROW regions. Envafolimab is already marketed in China.
It has already been included in the list of [inaudible] by the Chinese regulatory agency, and Envafolimab is, along with its key indication of being a PD-L1 for treatment of adult patients with previously treated MSI-High biomarker, Envafolimab is also being investigated in clinical trials for additional oncology indications like non-small cell lung cancer. Glenmark plans to file Envafolimab in more than 20 markets in the current year, and the first market launch is expected in FY 2026. Winlevi, in Q2, we announced the licensing of Winlevi with Cosmo. As mentioned earlier, the company recently announced the approval from MHRA in the U.K., and we are planning to launch Winlevi in FY 2026 in some of our licensed markets. Lastly, covering IGI, IGI and Ichnos Glenmark Innovation 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 outlicensed to companies, ISB 880, which has been outlicensed to Almirall, and ISB 830, which has been outlicensed to Astria Therapeutics. In terms of ISB 2001, this is a trispecific antibody for oncology and immunology. It is a BCMA CD38 trispecific T-cell engager that targets all the three biomarkers to harness the body's immune system against cancer. It is among the first trispecific antibodies developed for use in multiple myeloma. It received Orphan Drug Designation in July 2023 from the U.S. FDA. The phase one trial, first in human trial for relapsed refractory multiple myeloma, was initiated in November 2023. That's when the first patient was dosed. The trial is now active across centers in the U.S., Australia, and India. Dose escalation is currently underway.
In December 2024, 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. ISB 2001 has shown a very favorable safety profile with a very strong efficacy, overall response rate of 83%, along with 22% complete response or better and 50% very good partial response. The overall response rate was 75% in patients treated with CAR-T or bispecific T-cell engagers, and 80% of our patients remain on the treatment at the time of the data cutoff. IGI 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 one 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. Forex gain in this quarter was INR 23 crores, which was recorded in other income. R&D expenditure in Q3 was around INR 225 crores, roughly 6.6% of sales for Q3. Investment in IGI was $13.8 million. The total asset addition to the block during the quarter was INR 143 crores, of which tangible asset addition was around INR 72 crores, and intangible asset addition was around INR 71 crores. In terms of working capital at the end of December 2024, inventory was at INR 3,090 crores, receivables was at INR 2,914 crores, and payables was at INR 2,212 crores. Net debt for the period ended December 2024 was at INR 109 crores. We have the management of Glenmark Pharmaceuticals on the call today, Mr. Glenn Saldanha, Chairman and Managing Director, Mr. V. S. Mani, Executive Director and Global Chief Financial Officer, and Mr.
Ashish K. Mukherjee, Group Vice President and Head of Corporate Strategy. With that, we can open the call for Q&A. 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 their 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 the moment while the question queue assembles. The first question is from the line of Damayanti Kerai from HSBC. Please go ahead.
Hi, thank you for the opportunity. My first question was 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 growth profile for diabetes seems weaker than the market. So can you explain what is happening there and how should we look at this?
Sure. So 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 INR 1,100 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 fuller basis, right, we are pretty confident that we'll be able to meet our guidance, right, for the India business.
If I look at specifically each of the segments, cardiovascular, dermatology continue to 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 Lirafit, but every month we are getting better in terms of the supply of Lirafit. So I think Lirafit, once we come into full supply, which should be in the month of 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-1s, this is the first GLP-1, but once the subsequent assets come to market, that will further enhance our diabetes sales.
Across the four therapeutic areas that we operate in India, and of course, oncology, we are looking at a good FY 2026 primarily because of the BeiGene products, Tislelizumab and Zanubrutinib, which should contribute pretty significantly to the oncology business in India. These five segments will continue to do well for the company going forward.
Thanks, Glenn. But the stock level problem which you mentioned for Lirafit, it's 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.
In diabetes, we traditionally have two molecules, Remogliflozin, right, with the new Remogliflozin and Teneligliptin. With the new DPP-4s and GLP-1s 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 Lirafit, and Lirafit 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.
Okay, got it. My second question is on your U.S. business. So again, if you can share the status of Monroe plant because I guess we have been waiting for quarter after quarter, but if you can share the latest status, that would be helpful.
So let me start with just giving a broad overview on the U.S. business, right, before I go to Monroe. So if I look at the U.S. business, right, I mean, every quarter, things are getting better. I mean, I think Q4, we have some good launches which will ensure that we have Q on Q growth in the fourth quarter. If I look out to FY 2026, we have two major launches in the first half of FY 2026.
One is, of course, Fluticasone 44 MDI, right, Flonase, where we believe we have an exclusive position. We also have Fluticasone nasal spray, right, getting launched in the first half of FY 2026. Both these are very big products, so should contribute pretty significantly to the growth. In addition, we have the other strengths of Fluticasone MDI getting filed in FY 202 6 and one other respiratory MDI product getting filed in FY 2026. I mean, all this put together, right, in FY 2027, if you see the market potential of this entire franchise, right, the filings and the launches we are doing this year, you're looking at almost a $600-$700 million of franchise coming to market in FY 2027. In addition, we have three sole 180-day exclusivities/180-day first-to-file/exclusivities coming up in FY 2027 and FY 2028, which is another $800 million market.
So I mean, the next two, three years, FY 2026,FY 2027, and FY 20 28 should be strong years for the U.S. business. Now, with that backdrop, Monroe, 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. And these are mostly injectables, complex injectables. So I think longer term, given the geopolitical situation, I mean, we think Monroe should have a significant benefit, right, as we go forward. So it's only a matter of time. We think Monroe should pay back and start playing out as we go forward. Sure.
And when did you have your last communication with the FDA regarding Monroe plant?
So we did a meeting with them. I think it was a couple of months ago.
And since then, we send in constant updates to them on the status of our remediation.
Okay, Glenn. That's very helpful. Thank you.
Thank you. A reminder to the participants, anyone wishing to ask a question, may please press star and one. Participants on the conference, if you wish to ask a question, you may please press star and one. The next question is from the line of Nitin Agarwal from Dam Capital. Please go ahead.
Hi, thanks for taking the question. Glenn, on ISB 2001, is there any more update post the ASH data that you presented? And how should we look at this asset now going forward?
So clearly, ISB 2001 is a super exciting product, right, and has the ability to be a transformational asset for Glenmark and probably the entire multiple myeloma space, right, given the data we put out at ASH.
Subsequent to that, we've opened partnering discussions. We were at JPM. We did a number of meetings with a lot of companies, and there is a tremendous amount of excitement about the potential of this asset. We are clearly on course to finding a partner to drive ISB 2001. I mean, we've given ourselves till the end of this year, but it could be earlier. There is a tremendous amount of interest in the asset from a partnering perspective.
On this trial. The trial continues.
I mean, we continue dosing patients. We are hoping to start the dose expansion cohort in the next three to six months. I think that process continues. We'll have a significant number of patients before the end of this year. We'll have an update at ASCO on ISB 2001. The rest of the process continues.
From a partnering perspective, Glenn, are there any specific data points which are make-or-break data points that incrementally you are awaiting? Or how should we—
yeah. Go ahead, Nitin.
Glenn, 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 or not go through from here?
So we don't think that we are waiting on anything as of now, Nitin. So it's only—I think it's all procedural from here, right? So we've just opened discussions in January. So it's going through the process, right?
I mean, the point I was trying to ask you, the data that you've got so far is enough for us to conclude the deal?
Yes, it is.
Okay.
So how should one think about now, depending upon when the licensing happens, on the innovation R&D spend for us going forward?
Our view is FY 2026 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 U.S., so that's the journey for IGI, so we believe FY 2026 will be the last year of investment into IGI from Glenmark.
Right, and secondly, on the balance sheet, there has been this buildup of net working capital again. I think we are a little away from what we guided to at the start of the year for FY 2025.
So maybe any thoughts on that? Where should we end the year at? And what is driving this increase right now?
Yeah, sure. So Nitin, we had already. I mean, in the beginning of the year, we did sort of guide that the working capital will go. And some of the working capital items are pretty much close to what the industry levels are. In this quarter, obviously, there is some increase in the inventory based on. I know 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.
And if you could remind us what working capital days should we work with as a kind of sustainable number?
So maybe last quarter, we were at about 90+ . So I think those are the levels at which I would expect to be there.
Yeah. Okay.
And then lastly, you mentioned about Fluticasone MDI. When are you looking at an approval? What's your assessment on when the, what is sort of when will the approval come through for that for the first time?
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? Fluticasone 44 will get approved.
Okay.
And last one on the, Glenn, for the guidance for the year, we'll be tracking a little below on the EBITDA number, EBITDA percentage number that we had earlier.
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 third quarter, especially. If we adjust for that, we would be close to 19%. So we almost had about INR 71 crores coming out of some of the emerging markets in LATAM and also in South Africa, etc., and Russia as well. So I think if we 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 INR 10,000 plus crores. So Q4 is generally a good quarter.
So we should close to be about 3,500. So I think broadly, we would be able to meet the numbers that we gave you and barring for this adjusting for some of the currency.
So on the full year, Nitin, we will hit both our top line as well as EBITDA guidance, right, adjusted for currency.
And secondly, one last one, 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 YoY growth. I mean, do we expect—I mean, these are now more sort of sustainable trends on these overhead increases?
Yeah, 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 will be about 27%. And broadly, we are there only.
We are not going to exceed that, and obviously, expenses don't happen. Sometimes a little bit comes here and there in terms of how we wanted to sell marketing, but I very much see it where it is.
Thank you so much.
Thank you. The next question is from the line of Ashish from JM Mutual Fund. Please go ahead.
Yeah, thanks for the opportunity. So any update on respiratory and injectable segments for the U.S. market, especially you guys are there on the ground? Any update regarding the tariff discussions possibly in the U.S. market?
So respiratory, I have pretty much given you the roadmap, right? Between the three Fluticasones, Fluticasone 44, 110, and 220 put together is almost $500 million. In addition, you have Fluticasone nasal spray, which can be a substantial product.
We have one more respiratory MDI filing this year, which is another $200 million product. 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're 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 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 come into market. We have some good launches coming up in February 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.
That's 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 in when the GLP market in India opens up, how are we positioned? And yeah, any update will be very helpful.
So in the GLP-1, Liraglutide, Lirafit, 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 oral also.
So I think, although I think it will be a crowded market, I think we are well positioned to launch the products in India.
And how about in terms of integration? Obviously, we might be sourcing the drug substance and other products, other finished opportunities from the other parties. But in terms of the MRs, the field force, our front end, would we have to deploy incremental capital or resources?
At Glenmark, 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.
Fair enough. And lastly, obviously, adjusted for currency, you did mention that 18%-19% EBITDA margin run rate that we are already clocking. But going into FY 2026, with India coming back, U.S. also a lot many launches coming into picture. Any guidance on EBITDA margins you would like to give?
Yeah.
So if you recollect, even during our investor presentation, we had said that year on year, we expect a 1-1.5% 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.
Fair enough. Thanks and all the best.
Thank you. The next question is from the line of Kunal Randeria from Axis Capital. Please go ahead.
Yeah. Hi, good morning. Glenn, I heard your commentary on domestic business, but I'm afraid I'm not fully—
Sorry, Kunal, can you speak a bit louder? We're not able to hear you.
Yeah, sure. I hope that's better. Glenn, yeah, I heard your commentary on the domestic business, but I'm not completely sure I fully understand this.
See, the IQVIA 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 if 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 maybe just explain?
Yeah. So Kunal, as I said, look, we had guided to INR 1,100 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 we will meet our guidance, right, of 9%-10% and the INR 1,100 crores per quarter on an average, right, that we've guided towards.
But then, how would 4Q pan out? Because if I were to assume you'd be around INR 4,400 for the full year, last quarter would be around 900, I guess, right? Which would be what, flat to slight declining?
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.
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?
Sure.
I think the Indore plant got audited after six years, right? That's a, 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. I think from a revenue perspective, it's probably around 25% or 25%-30% of total U.S. revenues comes from there, from that facility.
Sure. And in terms of outstanding filings?
We have probably about four or five outstanding filings, but none of the products I mentioned are coming from Indore.
So it's more of our 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 Indore.
So your injectable one would be from Nagpur, right?
[crosstalk]
Got it. Got it.
Thank you and all the best.
Thank you. The next question is from the line of Anil Shah from Insightful Investments. Please go ahead.
No, yeah, most of my questions will be the answer. Thank you so much.
Thank you, sir.
The next question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead. Tushar, your line is in the talk mode. Please go ahead.
Yeah. Hi, am I audible?
Yes, sir. Please proceed.
Yeah. Sir, just with respect to generic flow and just want to understand if you have additional queries here.
No, we've responded to all the deficiencies from the agency, and we are waiting for them to respond.
So I mean, has this happened recently?
And that's the reason why the approval is sort of indicated in first half of the business?
I can't give more visibility than that. We've responded to everything. We're just waiting on the agency for the approval.
Okay. So secondly, on these three products which you highlighted about FTF 180-day exclusivity, where are we in terms of sort of filing approval cycle for these products?
So to the best of my knowledge, all the three are tentatively approved and are ready to get launched.
Okay. So more of the—so there's no litigation angle to these products?
No, they've all been settled.
Thank you. That's it for me.
Thank you. Before we take the next question, we would like to remind participants that you may press star one to ask a question. The next question is from the line of Bino Pathiparampil from Elara Capital. Please go ahead.
Hi.
Good morning, Glenn. Just a follow-up from the previous question. There is this product, Axitinib, Inlyta brand name,in which you have a tentative equivalent.I beleive you are one of the first to file.Are you the first to file?And is that a launch we can expect in the next one or two years?
You know,I cannot comment on the status of Axitinib, but clearly, we will—you will see us launching this product as we go forward.
In the next 12 to 24 months or beyond that?
I can't give you any visibility around that.
Oh, 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.
Thanks for taking a follow-up. Glenn, on the respiratory business, barring the set of filings we've talked about for this year, both on the—I mean, can you give us more color on how it is? Is there anything more from a pipeline perspective in respiratory for the U.S.?
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 Flovent, 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're able to get all these approved, the next three years should look very strong on the respiratory side for us.
Which I entirely get, Glenn. I'm just curious if there are more beyond this because.
Of course, we are working, Nitin, right, on the next set of products, right? But I mean, right now, we can't give any visibility. More near-term opportunities, obviously, we have outlined here.
And secondly, if you can just give us a little more color on how Ryaltris is faring, any sense on the size it has got to? I mean, what size are you expecting for the year on this?
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-$20 million of sales. So almost $80 million product for us.
And 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 Ryaltris, over time, we are pretty much on track to achieving $200-$300 million of sales, peak sales over time.
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?
Sorry, come again?
I mean, is there $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?
It's not the case. It's quite stable.
I don't think there is any royalty on Ryaltris. There's 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. In a lot of markets, as you know, we have put our own field force. We have almost launched it now in 43 countries, Nitin. So it's not a question of—so there's no major royalty or anything in this.
What I really meant is, is there a much higher margin business overall for us as a product than we just—
Yes, yes. It is a better margin product, Nitin, because in a lot of geographies, we have launched it ourselves. So that's how it works.
Okay. Thank you so much.
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. Utkarsh Gandhi for his closing comments.
Thanks, Glenn. Before we end the call, we would just like to state that the discussion materials provided during today's call, including the forward-looking statements and analysis made by the company or its affiliates, objectives, projections, and estimates of forward-looking statements, these statements are based on current expectations, forecasts, and assumptions. There are subjective risks and uncertainties, and actual outcomes could differ materially from these statements depending on the economic conditions, government policies, and other factors. No representation or warranty, either expressed or implied, is provided in relation to the discussion in the documents, and it should not be used by recipients as a substitute for 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.
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, and you may now disconnect your line. Thank you.