Good morning, ladies and gentlemen. Welcome to the Q1 FY23 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, moderator. Good morning, everyone, and a very warm welcome to the Q1 FY 2023 results conference call of Glenmark Pharmaceuticals Limited. Before we start the call, a review of the operations for the Q1 of FY 2023. Glenmark's consolidated revenue from operations for Q1 FY 2023 was at INR 27,773 million, as against INR 29,649 million in the corresponding quarter last year, recording a decrease of 6.3%. Excluding the global sales of COVID-related products in the Q1 of FY 2022, the year-on-year growth in the base business in the current financial year was at 10.4%. Let's review the performance of the formulation business, starting with India.
Sales for the formulation business in India for the Q1 of FY 2023 was at INR 10,352 million as against INR 12,250 million in the previous corresponding quarter, recording a decrease of 15.5%. This decline is mainly on account of a high base due to the sales of COVID-related products in Q1 of FY 2022. The India business growth, the India business contribution was at 37.3% to the total revenues of Glenmark in Q1 of FY 2023. As per IQVIA MAT June 2022, Glenmark India formulation business is ranked 14th with a market share of 2.17%. During the quarter, Glenmark's India business further strengthened its position in its key therapy areas such as cardiac and antidiabetic in terms of market share.
As per IQVIA MAT June 2022 data, cardiac market share increased to 5.18%, while the antidiabetic segment market share increased to 1.81%. As per IQVIA MAT June 2022, the company is ranked second in the derma segment, fourth in the respiratory segment, and the company improved its ranking to fifth in the cardiac segment. The company has nine brands in the IPM top 300 brands in the country, which is up from six brands last year on the basis of the June data. The company launched seven new products during the quarter, including Indamet for the treatment of uncontrolled asthma. Glenmark is the first company in India to market this innovative fixed drug combination of indacaterol, a long-acting beta-agonist, and mometasone, an inhaled corticosteroid.
This further increases the accessibility of quality drugs for effective asthma management in the country. The company has a healthy pipeline of differentiated products which it plans to launch in the market going forward. The India consumer care business recorded revenue of INR 647 million, with primary sales growing at 94% YOY. This was driven by strong performance in all the core brands such as Candid Powder, La Shield, and Scalpe. La Shield and Scalpe Plus registered their highest quarterly primary sales in this quarter, while Candid Powder maintained its dominant market leadership status and showed sharp recovery in sales during the current quarter.
The North America business, the North America business recorded revenue of INR 6,628 million for the Q1 of FY 2023, as against revenue of INR 7,878 million for the previous corresponding quarter, recording a YOY decline of 15.9%. North America business contributed 23.9% to the consolidated sales in the Q1. In the Q1, Glenmark was granted final approval and launched Abiraterone Acetate tablets. In addition, Glenmark also launched the previously approved product Azithromycin tablets. The company also received tentative approval for calcipotriene and betamethasone dipropionate foam. Glenmark plans to file one application in the forthcoming quarter as well as Para IV supplements to expand the OTC portfolio, which has been complemented by the acquisition of five approved OTC NDAs from Wockhardt.
The company plans to file 12-15 NDAs in FY 2023. Glenmark's marketing portfolio as of June consists of 176 generic products which are authorized for distribution in the U.S. market. The company has 48 applications pending in various stages of the approval process of which 20 are Para IV applications. Europe. Glenmark's Europe operations revenue for the Q1 of FY 2023 was at INR 3,300 million as against INR 3,059 million, recording a growth of 7.9%. The Europe business contributed to almost 12% of the total revenues for the Q1. The company witnessed steady growth in both its key markets of Western Europe as well as Central Eastern Europe.
Growth in Western Europe remained robust, led by double-digit growth across key markets like the Netherlands, Spain, and Nordic countries, while CE region maintained its strong growth through markets like Poland and the Czech Republic. Overall, the company launched multiple products across various markets in Europe during this quarter, and Glenmark's respiratory portfolio continues to do well across all European markets. Glenmark has a comprehensive plan to grow its European business going ahead, including geographical expansion into new markets and portfolio expansion to leverage launches in key therapeutic segments like respiratory and dermatology. The ROW business, which consists of Asia, Middle East, Africa, LatAm, and Russia CIS.
For the Q1 of FY 2023, revenue from the ROW region was at INR 4,226 million, as against INR 3,260 million for the previous corresponding quarter, recording a growth of 25.8%. ROW business now contributes more than 15% to the total revenues of Glenmark as of Q1 FY 2023. The challenging conditions in Russia as a consequence of some of the economic sanctions led to erratic consumer behavior in March, which impacted the sales to an extent in the Q1 of FY 2023. Secondly, sales actually decreased -11% YOY in value terms during the quarter. However, the company has received approval for some interesting products like Dimetindene gel, which strengthens the derma portfolio in the region.
RYALTRIS also received approval for an additional indication, and the overall response to RYALTRIS has been very encouraging in the market. The company has various strategic initiatives to further strengthen the respiratory franchise in the Russia CIS region going forward. Asia has continued its strong performance, led by positive momentum in key markets like Philippines and Malaysia. The company has extensive plans to strengthen its respiratory franchise in the Asia markets with the launch of RYALTRIS in FY 2023. Middle East Africa region recorded secondary sales growth of 19% during the quarter, and positive growth was recorded across major markets like South Africa, Saudi Arabia, and the UAE. The company expects this growth momentum to continue for the rest of the year. Latin America witnessed a steady growth of more than 30% in the region.
Markets like Mexico, Colombia, Ecuador witnessed a strong growth momentum in the respiratory business, particularly on the back of prescription-generated demand. Glenmark's Brazil business also delivered growth on the base product portfolio. On the respiratory side, we'll give some key updates for Glenmark's global respiratory business for the Q1. For RYALTRIS, a few updates. During the Q1, Glenmark received marketing authorization grants for RYALTRIS in Singapore and Bahrain. The company is awaiting regulatory approvals for its filings in key markets like Canada, Brazil, Malaysia, and several other emerging markets. Glenmark's partner in the EU, Menarini, initiated the commercial launch in Ireland and intends to launch the product in additional European markets in the coming quarters. RYALTRIS sales continue to grow in all the markets where the product has been launched over the last few quarters.
Glenmark has also been working with its partner in South Korea, Yuhan Corporation, to enable commercial launch in the Q2 of FY 2023. Glenmark's partner in Mainland China, Grand Pharmaceutical Group, initiated enrollment in the phase 3 study in China in April 2022 as well. Glenmark's exclusive partner for RYALTRIS in the US, Hikma Pharmaceuticals, is also preparing for the product launch post receiving U.S. FDA approval. Other key updates. The clinical trial is ongoing for the generic Flovent pMDI. We expect to file for this product in calendar year 2023. We also plan to file at least one more respiratory pMDI in the US in calendar year 2023, and subsequently continue our filing momentum beyond FY 2024.
As mentioned before, we launched Indamet for the treatment of asthma in India, and our European respiratory franchise across key products such as Salmex and Tiotropium pMDI are also shaping up well in both Western Europe as well as CE markets. Some updates on the innovative R&D pipeline. GRC 17536 is a TRPA1 antagonist and the company's pain pipeline asset being developed as an orally administered treatment in patients with painful diabetic peripheral neuropathy. GLP toxicology studies were completed last year, and a phase 2B study was initiated in Q2 of FY 2022. This is currently ongoing, and interim data for futility analysis is expected by the Q2 of FY 2023. GRC 54276 is an HPK1 inhibitor and the company's oncology pipeline asset currently being developed as an orally administered immuno-oncology adjuvant treatment for patients with solid tumors.
A phase 1 study is currently underway, and Glenmark is targeting to file for a U.S. IND in the second half of FY 2023. GBR 310. Glenmark had earlier announced successful phase 1 results for GBR 310 that suggested similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between GBR 310 and the reference product Omalizumab. Glenmark is in discussion with potential partners to out-license the product. GRC 39815. This is a RORγt inhibitor and the company's respiratory pipeline asset being developed as an inhaled therapy for the treatment of mild to moderate COPD. The product is currently under phase 1 clinical development in the U.S. Now, a quick update on Glenmark Life Sciences.
Consolidated revenue from operations for GLS, including captive sales, were at INR 4,899 million, as against INR 5,249 million, recording a YOY decline of 6.7%, which was mainly due to the high base of COVID products in the sales last year. During Q1, regulated markets contribution remained stable at more than 72%, while emerging markets witnessed a growth of almost 24% YOY excluding COVID products. GLS has also received environmental clearance for the installation of a 1,000 KL capacity greenfield manufacturing site at Solapur, and construction work will begin in the current financial year. External sales for GLS in Q1 of FY 2023 were at INR 3,251 million as against INR 3,040 million in Q1 of FY 2022, recording a growth of 6.9% YOY.
An update on Ichnos Sciences. Landmark has invested INR 1,682 million in the Q1 of FY 2023 as compared to INR 1,617 million in the corresponding quarter last year. For further updates on the pipeline, especially for the Q1 of FY 2023, please visit the Ichnos website. There is an update published on the Ichnos website. We want to just set out our key objectives for FY 2023, and we reiterate what we had said in the Q4 call. Revenue growth of 6%-8% during the year, sustaining EBITDA margin performance at similar levels to FY 2022. A CapEx of INR 7-8 billion. Strategic priority remains to enhance free cash flow generation for further debt reduction and closing out 1-2 out-licensing agreements in our innovation pipeline.
Some notes to the results before we open the Q&A. We had a COVID-related inventory provision of INR 41 crore in the Q1 of FY 2023. Adjusted for that, our EBITDA margin for Q1 was at 17%. Forex gain for the quarter was at INR 167 crore, which has been recorded in other income. Gross debt for the period ended June 30, 2022 was at INR 3,765 crore as against INR 3,670 crore in March. Net debt for the period ended June 30, 2022 was at INR 2,392 crore as against INR 2,251 crore in March. The increase in net debt was primarily on account of currency movement during the quarter.
In terms of working capital inventory for the period ended June 30th was at INR 2,739 crore. Receivables were at INR 2,950 crore, and payables was at INR 2,456 crore. Thus there was a net working capital reduction of almost INR 80 crore as of June when compared to the March numbers. Total asset addition in the quarter was at INR 169 crore, of which tangible asset addition was about INR 139 crore. R&D expenditure for the Q1 was around INR 298 crore, which is about 10.7% of the total net sales for the Q1. Before we open the floor up for Q&A, I would just like to introduce the management of Glenmark Pharmaceuticals on the call today. We have Mr.
Glenn Saldanha, Chairman and Managing Director, Mr. V.S. Mani, Executive Director and Global Chief Financial Officer, and Mr. V.S. Reddy, Chief Executive Officer, Global Formulations Business. With that, we'd like to open the floor up for Q&A. Over to you, moderator.
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. Participants in the conference, if you wish to ask a question, you may please press star and one. A reminder to the participants in the conference, anyone wishing to ask a question, may please press star and one. The first question is on the line of Akshita Jain from Edelweiss Securities. Please go ahead.
Just one question on just debt reduction. Any guidance on FY 23-
Sorry to interrupt. Ms. Jain, we are not able to hear you clearly. Your voice is hardly muffled.
Hi. Is it possible this is better?
Much better. Thank you.
Yeah. Any guidance on debt reduction for FY 2023? Because if I see in the last two quarters, our debt has moved up. Maybe this was because of currency, but any guidance on that?
Sure, Akshita. This is V.S. Mani here. Obviously during this quarter also the rupee moved substantially, so that's mainly the reason why there is an upward movement in the debt. During this quarter, we had you know, the FCCBs were refinanced, okay? We had a one-time big premium payout, though the accruals or the premiums were done over the years, but the payout happened this time. Going forward, I see the debt kind of coming off as the year goes by. Definitely on a constant currency basis, we should see it go down, yeah.
Any number that you would like to call out, sir?
I would not like to throw a number, but definitely it will be different. You know, we expect it, on a constant currency basis, we certainly see it going down, yeah.
Okay, thank you. Second question is on the COVID inventory position. In the last quarter, we did roughly around INR 38 crore. This quarter, INR 41 crore. What is the balance inventory left in the COVID, which you would look at in the future quarter?
During the last quarter also we had said that in the channel we have about INR 80 crore-INR 90 crore. I think INR 40 crore has come in. Going forward, another INR 40 crore-INR 50 crore is something that we could see. I mean, I don't think COVID there is much there, so this could definitely come back. That's what we look at the outer limit.
Okay. Just lastly on this RYALTRIS, could you help us understand this opportunity in the U.S. market as well as in the outside U.S. market?
Sorry, can you just.
For the channels.
Can you repeat that?
My question is on RYALTRIS.
Yeah.
How big this opportunity can be for you in the U.S. market as well as outside U.S.?
We are not breaking it up, but I think RYALTRIS for us, we think over a 3-year timeframe, 3-4 years can be a $100-$150 million product. Across all markets.
Just from the U.S. Oh, across all the markets. U.S. would be the major chunk, 60%-70%.
Not necessary.
Okay.
U.S., we have a partnership with Hikma, so obviously there we will be entitled to part of the economics, not the full. In the other markets where we're commercializing on our own and various other markets, right, the revenues will flow through those markets.
How is the partnership with RYALTRIS? Is it profit share or how is it? How is it structured?
We can't give any visibility around that, but clearly most of these deals are around royalty and a revenue royalty share and profit share.
Okay. It should be likely in the single digit kind of royalty.
I can't give you this. We cannot share.
Okay. Thank you, sir. That's also enough, sir.
Thank you. The next question is from the line of Gaurang Sakaria from Motilal Oswal. Please go ahead.
Hi, sir. Thank you for taking my question. I hope I'm audible.
Yes, you are.
Yeah. I just wanted to know that, what is the update on remediation measures at Monroe facility?
I mean the remediation is currently underway, right, at Monroe. You know, if all goes as per plan, we are hoping to get back into commercial production around Q4 of this year.
Thank you, sir. Sir, secondly, could you guide us on what were the key reasons for such a steep decline in US sales during the current quarter? Any outlook do you have on US segment over FY 2023?
Yes, I'll take that question. You know, the U.S. business is undergoing challenges. Every organization has the same one. There's volume impacts. We've had a few volume impacts just due to global supply disruptions. We are recovering from that. We also continue to see price erosion in the U.S. market, all manufacturers do, and price erosion is really the amount is impacted by products that are newly approved products in transition in your base. Then you take into consideration product approvals coming out of the FDA are unpredictable. All of those things make U.S. a very challenging environment where we've been impacted in Q1. That's basically the reason for the decline.
If you look at the business for the rest of the year, we have 10-13 approvals that we should see in the U.S. this year, or total opportunity of those. Our volumes are recovering and overall we see the outlook for the U.S. Q2 should be better and we see our business strengthening as we go throughout the year in the U.S. Optimistic that things are moving in the right direction.
Broadly, do you think we can maybe remain flat on FY 22 base, or do you think we can grow, let's say mid- to high-single digits?
We're looking at flat to low single-digit growth in the U.S. for FY 2023 compared to FY 2022.
Okay. Thanks a lot. Sir, one more on the, I mean, the consumer care business. It has witnessed a phenomenal 94% YOY growth in one year FY 2023. Can you give a brief color on how sustainable is this and what should we expect for let's say FY 2023 and even next year?
I think the consumer care business is growing. I mean, obviously 94% is not sustainable, but I think we will have high growth coming out of this business as we go forward because of some of the new launches, some of the new channels that we've opened up, which should drive the consumer care business.
Okay, sir, and regarding, I mean, continuing on domestic business. In domestic formulation business, can you guide us on the number of product launches and how many of these would be first to market during FY 2023 and 2024?
I mean, typically on the domestic business we launch 20, 30 products a year. Right? You know, given that, I think we have some exciting launches in the diabetes space. Respiratory also, we have some good launches. I mean, these are typically some of the launches, which will drive the growth this year and drive the growth next year.
Okay. I mean, what would be the growth guidance for domestic formulation this year?
typically our base business is growing at 15, 16% minimum, right? I mean, that's the July numbers also that came out were 16% in AWACS and about 10% in IQVIA, right? Fifteen, 16% is our normal growth on the base business. This is ex-COVID drugs, right? Even today, we're growing at that pace. We think we can sustain this this year and probably part of next year.
15%-16% ex-COVID business, you think it's-
That's our current growth rate.
Okay. Lastly, on the contribution of Baddi facility to U.S. sales any update on the feedback on observations raised by the U.S. FDA in recent inspection?
We have no feedback, right? We went through multiple inspections in Q1, and we responded adequately, and we are still awaiting feedback from the agency.
Okay. Can you give us the confidence-
Sorry to interrupt, Mr. Gaurang Sakaria. May we request that you return to the question queue? There are participants waiting for their turn.
Sure. Sure.
Thank you. We'll move on to the next question. That is from the line of Harshita from Sanford C. Bernstein. Please go ahead.
Hi. Thanks for taking my question. My question was on respiratory space. What are the upcoming milestones which we will be able to see in incoming quarters for respiratory?
I mean, the respiratory business is a global business for Glenmark, right? We've done a lot of different things in different parts of our respiratory franchise. For example, in India, we launched you know, Indacaterol for the first time, Indacaterol mometasone as the first launch in India. We launched the Fluticasone propionate highest strength for the first time in India. There are lots of good launches in respiratory in India and also in the quarter we got approval for two strengths of beclomethasone in Brazil. Europe, we have four or five big drivers for our respiratory franchise. u.s. we're running Flovent clinical trials, and we are hoping to file one more product in addition to Flovent next calendar year. It's truly a global franchise for us.
Of course, ryaltris there's enough visibility on the launch of RYALTRIS in so many different markets, right? Hopefully our U.S. launch also is imminent anytime. I think the whole respiratory franchise globally is a big franchise for us.
Okay, thank you. Was there any specific challenges in terms of recruitment, especially in COPD because of COVID?
You mean patient recruitment?
Yes. Yes. Yes.
I think it's always been a challenge, right? I mean, multiple trials ongoing across the world. Patient recruitment is always a challenge. I think we're doing okay, particularly on the Flovent trial, right? We're making good progress in patient recruitment.
Okay. In terms of biosimilars, what are the updates which we can see for CSU or maybe asthma?
We just have one biosimilar in our pipeline, which is Xolair, and which has completed phase one. We are not moving forward. We are working on getting a partner on board to take the drug forward. Other than that we commercialize multiple biosimilars through partnerships, but we are not developing our own biosimilars.
Okay. Thank you. Thank you.
Thank you. Before we take the next question, we would like to remind participants that you may press star and one to ask a question. The next question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Yes. Hi, good morning. Glen, on the Monroe facility, what-
Sorry to interrupt. Mr. Mukherjee, your audio is breaking up.
I'm sorry. Is it better now?
Much better.
Yeah, we can hear you, sure. Yeah. No, no. I was wondering on your Monroe facility, after the last inspection, do you have a classification as a VAI, OAI? I'm just wondering what is the status and what's the timeline?
As on today, Saion Mukherjee, we haven't heard back from the agency. We have no visibility on any timeline or classification.
Okay. Are you getting approvals from the site at this point, or those approvals are currently not coming?
No, currently we're not getting any approvals.
Okay, fine. The second question I had was on Europe. The inhalers that we have launched, can you share, first, like, how large is that business, inhalation business in Europe, and what kind of market share we have been able to achieve in Europe?
There are multiple products there, right, Saion Mukherjee. One is, of course, Tiotropium is a big one, right, for us. Then we've got Salmex, right, which is salmeterol fluticasone. These both were launched as first generic. Then we've got beclomethasone, right, in Europe. In addition, we have Ryaltris in different markets, right? We have a couple of more launches coming up, right, over the next 18 months, right, in Europe. It's a pretty broad portfolio. In terms of market share, across Europe, it's virtually impossible to guide because it's different in different markets, and it's super complex, right, to guide. But it's a substantial contributor to our total revenues already. We are expecting Europe to grow overall 15%-20% CAGR, right, going forward.
Given that a lot of the growth is gonna come out of RYALTRIS and out of some of the respiratory products that we launch and we continue launching. It's a big contributor going forward to the total revenues.
Understood. I was just wondering, some of the Salmex and Tiotropium that you've launched, at least in the key markets, right, in the U.K., Germany, if you can share some market share in some of the larger markets, typically like how much one can expect to get in these markets.
I mean, my guess, Saion, is it'll be in the 10%-20% range, right? Somewhere thereabout.
Okay.
In terms of the market share. That's only a guess, Saion, at this point.
Okay.
Could be higher in some of these markets, could be lower.
Understood. Just on the respiratory pipeline for the U.S., you talked about Flovent. Can you just share how large is the opportunity? What is the competitive dynamics there? And any other product. I think you mentioned one more product. If you can share how should we think about from next year in terms of filings that you would be doing, what kind of expenditure one would incur in developing these products, and just a broader thought on the respiratory development programs that you're doing in the U.S.
Flovent alone is a $1.6 billion, approximately a $1.6 billion product, as far as I know. I think, to the best of our knowledge, there's 1 other filer, which is Teva. We are not sure about if there's anybody else running clinical trials. To the best of our knowledge, we are probably second in that, in that list on Flovent. Our filing goes out next calendar year, which means we would launch 2025, right, approximately, right? Early 2025. That's our estimated timeline for Flovent. We have 3 products in development for the U.S., of which, as I said, 2 will get filed next year. One of them is Flovent. There's 1 more product. We have a third product in development. Basically, our view on. We will,
You know, we typically have about three odd respiratory programs in development at any time for the U.S.
Glenn, I mean, from a commercialization perspective, if I look at FY 25 and/or FY 26, there can be two commercial products including Flovent in the U.S. if everything goes right.
That's correct.
Okay. Thanks a lot. I'll join back the queue. Thank you.
Thank you. A reminder to the participants, anyone wishing to ask a question may please press star and one. Participants in the conference, if you wish to ask a question, you may please press star and one. The next question is from the line of Shyam Srinivasan, an individual investor. Please go ahead.
Hi, this is Shyam Srinivasan from Goldman Sachs. Just one question and I join you, so please apologize if it's been answered. Just on employee costs. Actually noticed that we typically have a 2Q bump up, right? But this time we have seen a bump up even in 1Q. Has that something that's changed in the way you recognize the employee costs?
Yeah, Shyam. V.S. Mani, yeah. You are perfectly right. We decided to pay out the bonuses in two quarters, one in Q1, another in Q2. Okay. So that it kind of measures well over the year. Okay.
Mani, should we assume this going forward because we already used to model, like, 2Q higher?
Yeah, yeah. I think, yeah.
Yeah, 200 basis higher. Yeah.
Yes. Going forward, you can spread it out over the two quarters. Yeah, that'll be better.
First two quarters of the fiscal. Got it. Just in terms of just the underlying dynamics of employee costs in terms of either inflation how are you seeing things for the full year, how should we look at it?
I think, Shyam, it's pretty stable, I think. We are not seeing major spikes in employee costs, right? I think for a full year, I mean, it should be single digit growth.
Yeah, it will be normally like how we have 7%-8%, maybe around that.
Yeah. When you guide us to the EBITDA levels being same I am assuming this is the 18%-19%, right? What's the level? Sorry, I didn't pick that up. Sorry.
Yeah. We had earlier also guided to something closer to what we did last year, so 18% or closer to 19%. We still believe we can reach there. I mean, obviously the Q1 there were some input cost increases, et cetera, et cetera. The Q2 onwards, we feel it should be much better. Yeah.
Got it.
Historically our Q1 sales are much lower compared to the other three quarters. I mean, in some ways as the turnover goes up in the next three quarters, we should see better numbers.
Got it. My second question is on the India business, and I'm stripping out the INR 350 crore last year of whatever COVID and COVID allied. You've grown 18%, if I do the math right. Two-year CAGR is some 10, 11%. Sorry, three-year CAGR. Just wanna understand how should we look at it? Or should we be higher than 10% or should we be closer to 18% when we look at the forward path? And if you can help us understand either from a new product launches, or volume growth on your existing business, how things are panning out there.
Right now, Shyam, in July, IQVIA, I mean, AWACS showed us at 16%. And IMS was lower because the market also, IMS was lower. I mean, I think we believe on our base business it will be like 15%-16% growth for the full year coming out of India. We are expecting strong growth. We have lots of good launches, particularly in respiratory, diabetes. Diabetes, we launched sitagliptin/dapagliflozin, first generic on sitagliptin, first generic on sitagliptin/dapagliflozin. We have a number of other launches coming up, right? In respiratory we have Indamet, which is indacaterol mometasone, first generic. Vilanterol/Fluticasone, first generic in respiratory. There's a ton of good launches, right, in the space which will drive your India growth, right?
In addition, of course, our core brands continue to do very well, right? Whether it's your Telma, Candid, Ascoril, Alex. We have very strong brand franchises, right, across the space. The last thing is our OTC business is doing very well. Our consumer care business, right? And that continues to do well. I think there are multiple triggers to the India growth strategy for Glenmark.
Got it. Yeah. Thank you and all the best.
Sure. Thanks, Sham.
Thank you. The next question is on the line of Saion Mukherjee from Nomura. Please go ahead.
Yeah.
Mr. Mukherjee, we are not able to hear you.
Yes, go ahead, Saion.
Yeah. Sorry. The India business, just to continue, is there any headwind, some of the big molecules that you have, Remo, teneligliptin because of all the patent expiries that are happening? Is that something hurting your overall growth or you think it is. You are able to manage it overall 15%-30% that you're guiding?
Saion, while you know Remo, the mono components are not doing great, we have Remo-M which is doing well for us, the triple, right? We're the only one that has a triple combination there. likewise teneligliptin, so some of the erosion that we've seen some of our older products, right, may be more than compensated with the Sitagliptin franchise, okay? Some of the newer launches. We also have one more big launch coming up yet this quarter in the diabetes space, right? Which again, will be a first time in the country kind of a launch, right? So that also could be a substantial contributor.
I think all in all whatever slight erosion we are seeing in some of the older molecules like Remo or even teneligliptin, right? We're more than able to compensate with the new products that we're launching.
Okay. That's helpful. Glenn, the second one is on IND. Any further update you want to share in terms of timeline of the clinical trial outcomes that we should look out for?
For ichnos the next six, seven months is very important, right? We are hoping to get POC on ISB 1342. ISB 1442, we start dosing any time now, right? Our first-in-human. We have ISB 2001, which will enter the clinics in Q4 of this year. If all goes well, we should have two POCs on ISB 1342, ISB 1442. We should have ISB 2001 in the clinics, so three oncology clinical assets by the end of this year. We are hoping to close one licensing deal yet this year. That's on course. I think given all that, right, there could be some significant value creation in Ichnos this year. Of course, the capital raise towards the end of this year is something we still target.
Once we get these three clinical assets in the going and two POCs, and one licensing deal, right, on the back of that, we are hoping to do the capital raise.
Okay. Glenn, the second question is, can you share, like, what's the outlook like for your markets, like Russia and
Sorry, Saion Mukherjee, you just broke up. Can you repeat that?
Yeah, yes. You know, asking about the outlook for Russia and Brazil in particular.
Russia. Look, Russia is doing well, okay, Saion? Right. russia despite the war and everything, we still the market growth is still good. That coupled with the fact that the ruble remains strong, right? And we took some price increases, right, on account of inflation. We see a good year in Russia this year. Brazil, we think, has now turned the corner for us, right? I think the next two, three, four years should be strong years for Brazil. We launched the other two strengths of Daktela. We are expecting Ryaltris approval in Brazil, sometime this year, right?
We have a couple of good filings, right, which should come through, get approved either in Q4 of this year in the respiratory area or early next year. I think Brazil, we think will be a strong market for us going forward.
Okay. just one last question, Glenn, I just wanted to check on the profitability front, Europe and Latin America, I understand historically these geographies were struggling. Now with at least Europe scaling up and Latin America turning the corner, how should we think about, let's say, the EBITDA contribution from these two regions?
Go ahead, Manny.
Sure. Saion Mukherjee, over the years Europe, with also with the amount of, good product launches that we had with RYALTRIS, Tiogiva, and also a couple of other good respiratory products. Over the years, the profitability definitely has improved. I think, today we can even see some of the EBITDA margins much higher than what it used to be historically. In some of these Latin American markets, in Brazil, et cetera, again, when we say turn the corner, at least we are now, better than breaking even at least during the current year. I don't see it. All this should help us to get close to our overall objective of getting at least an EBITDA margin that we kind of guided toward the end.
Okay. Great.
Thank you. Before we take the next question, we would like to remind participants that you may press star and one to ask a question. The next question is from the line of Umesh Matkar from Ashirwad Financial Services. Please go ahead.
Thank you for the opportunity. I would like to know, did we incur any remediation cost this quarter? Going forward, are you expecting any? Second, are you confident of launching RYALTRIS with observations on certain plants? Thank you.
Ryaltris, as I said we are expecting launch anytime now, right? Manufacturing is clear right now, right? We've got approval basis done. We're expecting launch anytime, right? For Ryaltris in the US.
As far as the remediation cost, obviously, I mean, previous quarter we did see we had given one about almost INR 10 million or whatever. This quarter we didn't have much. Going forward, there could be some. As and when we incur some of these, we'll put that across. Yeah. A good amount has already been done. That's what I can say.
Yeah, last question, sir. I heard you mentioning single-digit growth in U.S. Is it because of new launches? Or are you saying are you expecting lower price erosion on your products going forward?
I think the U.S. business is stabilizing, and I think it is. We have, as I said earlier, we have about 10-12 products that we can launch this year. We've had 2 that we've launched so far in the Q1. We just had another approval. We still have a stable of 10 products that we can launch this year. We expect the Q2 to be better than the first, and we expect the third and the Q4s to be better than the first and Q2. I think things in the U.S. are trending in the right direction and it's a matter of execution, stabilization of our base business and new product launches.
Yeah. That's it. Thank you.
Thank you. A reminder to the participants, anyone wishing to ask a question, may please press star and one. As there are no further questions, I now hand the conference over to Mr. Utkarsh Gandhi for his closing comments.
Thank you, moderator. We will read the disclaimer before we end the call. Information, statements, and analysis made in this document describing the company's or its affiliates' objectives, projections, and estimates are forward-looking statements. These statements are based on current expectations, forecasts, and assumptions that are subject to risk and uncertainties, which could cause actual outcomes and results to differ materially from these statements depending upon economic conditions, government policies, and other incidental factors. No representation or warranty, either expressed or implied, is provided in relation to this document. This document should not be regarded by recipients as a substitute for the exercise 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 this, we end the call today.
A big thank you to all of you for joining us on the call.
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 lines. Thank you.