The first question is from the line of Damayanti Kerai from HSBC.
Quarter ended Jun 2024
My first question is like you have seen a good pickup in India. So that, I guess, very comforting. But looking at U.S., I guess, still remains a bit soft. So what are your expectations on U.S. sales recovery? And how do you see -- like do you have any visibility on FDA regulation for Monroe plant?
Sure. So the U.S. business continues to remain challenging. But I think the second half of this year, right, once we get our respiratory products approved, right, I think that's when you'll really see the recovery, right? As you know, we have a number of respiratory products, which are filed and we are waiting for approval. So as and when that happens, you will see a significant recovery for the U. S. business. As regards to the Monroe facility, the FDA has given us a meeting in September. So we are hoping that it will bear onwards, the facility will restart.
Okay. So better U.S. we should be assuming starting second half. So even if, say, Monroe takes some time, you mentioned you have a couple of respiratory products. If those come, those should be -- may contribute meaningfully and then see better U.S. sales?
That's correct.
Okay. And then a question on margins. So this quarter, obviously, you have delivered healthy margins. But moving from, say, close to 18% margin in 1Q, you have given guidance of 19% for the full year, which will be the key contributors, if you can just update us on those?
So thanks for the question, Damayanti. So obviously, we had in this quarter also adjusted for ForEx, we were almost 18.8%. We have guided to about 19%. Obviously, the key contributors will be -- obviously, India continues to do well. India is a high-margin market. Besides that, our product, Ryaltris, continues to do well. Last year, we have guided to almost $80 million of sales this year. And as earlier we alluded, we already filed it in a number of markets and some key filings are also coming up across various geographies. So I think -- and also a number of Respiratory products that we are hoping to get approved and launched in Europe as well. So I think all in all, all this put together, that gives us the confidence to come very close. Besides, as you see -- you can see on our R&D expenses are lower compared to last year as well. So all this should help us to reach close to 19%.
Sorry, just to add. So typically, our second half is a little better because of the respiratory products getting further uptick. So margin profile also will accordingly be slightly better than H2.
Okay. Just a question on your R&D spend for Innovation IG. So is this the label like, which will sustain? Or do you have further room to reduce it?
I think for this year, we will be around the same level, so around 55 million full year. Next year, if you look at our investor presentation, right, we're clearly guiding towards -- I mean, I think if we do a partnership, automatically, these numbers will further reduce substantially in FY '26. This year, our goal with IGI is to get to PoC, and we are seeing some very good data on 2001, which we'll present at ASH. And next year, you should see some partnership activity, right? I mean that's the road map for IGI.
The next question is from the line of Tushar Manudhane from Motilal Oswal Financial Services.
So just extending on this U.S. FDA thing, if you could also highlight what's happening with respect to Goa and Baddi side?
So we've completed the remediation for Goa and we will be lobbying with the FDA to come and inspect us, right? I mean that's kind of where we stand with Goa. Regarding Baddi, for the time being, our focus for the U.S. market fr om the Baddi side is reduced. So it's not that significant for us. Basically, the 4 major sites for the U.S. market for Glenmark are Goa, Indore, Aurangabad and now Monroe, right? These are the 4 sites which we supply the U.S. market. Also, keep in mind now U.S. market is 24% of total sales, right, for Glenmark, right? And given the European performance, right, we are thinking that the European business could be as big as -- almost as big as the U.S. business by the end of this year. So there is a big shift in the overall revenues for the company if you look at the overall picture.
Understood, sir. So -- and further this, the gross margin, even on a quarter-on-quarter basis where our India, Europe sales has been higher, still the gross margin is sort of lower. If I think about it on a quarter-on-quarter basis, whereas even the raw material cost has been relatively subdued or soft at least as far as the industry-wide phenomenon goes. So if you could explain that.
Yes, so I me an, compared to quarter -to-quarter, it was almost 67% in the last quarter. I also guided at that time. It can always be plus/minus 1%, depending on product mix, yield, etcetera. On an overall basis, we would like to guide that will always be close to 65% t o 67%, give and take a percentage here or there. That's how we look at it.
Understood, sir. And if you could also call out how much has been the Ryaltris sales overall for the quarter?
It's closer to $20 million in this quarter.
And how big this potential can be for China market?
So I think, look, Ryaltris for a full year, right, we anticipate close to $80 million of sales, right? We are pretty much on track to achieving that, right? I think Ch ina, some of the new markets, we are still not guiding towards but the launch is still a year or 2 away. So we have 3, 4 markets, which are still to be launched starting next year, which is mainly China, Brazil and a couple of other major markets, which will start contributing.
Understood. And sir, just lastly on WINLEVI, the launch still in FY '26. So anything -- any major milestones to be achieved before we go ahead with the launch? Given that it's taking almost 3, 4 quarters.
I mean it's just we're waiting for the approval from the European agencies, then we have price approval to be taken. That takes its own time. So it's all the pre -launch activities that we are working on. There's nothing beyond that to look at. And in some markets, we could launch end of this year. But conservatively, we are seeing F '26.
The next question is from the line of Kunal Randeria from Axis Capital.
So I think the liraglutide is a great opportunity. We are still challenged with some supply issues as and when we have sought that, it should be a good product to have in the portfolio. Currently, the initial offtake is very good for the product.
But then, what's the market size, I mean pre-generic market size?
So Kunal, the whole GLP-1 market is -- it is about, I think, INR1,000-odd crores as per IQVIA. But I mean that's not a good reference point because it's still very much under-penetrated and...
And also, I mean, keep in mind, liraglutide is a daily injection, whereas sema and some of the others are weekly injections and beyond. So it's a great product to have in the portfolio. It will do well. However, with semaglutide and some of the other GLP -1s, eventually, the focus will shift to the other GLP-1s over time.
Sure. Sure. So then if I understand correctly, generics could increase the volume, but then it will be offset by some of the existing patients moving to sema and others. So there -- I mean not really much from a revenue perspective to increase the market price.
No, there is scope, and that's something you will see in the second half of this year. We will continue to gain market share on liraglutide in the second half, right? But I think keep in mind that semaglutide goes on patent in '26. So there will be some shift, which will happen between lira, sema and some of the other anti-diabetic treatments, right, post '26.
Yes. Got it. Okay. Second, again on India. So while 12% growth is quite strong. IQVIA showed somewhere around 15% to 16% over the last few months. So I just want to understand what there -- is there a discrepancy?
It's hard to -- I mean, look, our India growth is strong. The takeaway message is that we are outperforming the market consistently. And that will sustain, I think, going forward. So we're seeing strong growth in all our therapeutic segments that we operate in. And except for acute respiratory and diabetes, these are the 2 segments where there was a slight struggle in Q1, which we think will change over the course of the year. India growth, all in all, is strong, right? But I think overall, you should peg us at 10% to 15%, right, 10% to somewhere thereabouts, right, on a full year basis.
Sure. Sure. And just one for Mani sir, the depreciation and the tax was quite low in the quarter. So if you can just run us through what happened and what the expectations now for the rest of the year and next year, too?
So just to give you our guidance broadly, the depreciation and tax as well as interest, all this will be pretty consistent throughout the year what we see in Q1. And as far as depreciation goes, as you know, last year, we did have some of the write-downs, etcetera. So all that helped us to bring down the depreciation. Plus, obviously, you can see in the Q1 a lso, there has not been too much addition to the block. So I think we'll see how the year progresses, but broadly, this is where it should be. As far as the tax, even last quarter, last year, I kind of indicated and guided that will be between 25% and 27%. That's where we will be. Yes.
So what is driving lower tax? I mean U.S. would still be making losses, right? Perhaps Ichnos losses have come down, but what's driving this?
Yes. But some of the other -- like Ryaltris, etcetera, are doing well, some of them are based out of Europe, etcetera. So some of those places the tax rate are little lower now. So that helps us a lot. Yes.
The next question is from the line of Nitin Agarwal from DAM Capital.
Glenn, on the Ichnos, what should we look forward to in Ichnos over the next 12 to 18 months? I mean any milestones? And by when you should expect them to play out?
So Nitin, as I mentioned, right, 2001 is doing really well for us, and we will do a presentation at the ASH conference, right, in December, right? At that conference, we will put out our clinical data, which should generate quite a lot of excitement in the community. So that's the near -term thing. And then after that, of course, the goa l is to do a partnership sometime next year around 2001.
And when is the readout for the other molecule expected, Glenn?
So currently, there are two, which are in active clinical trial, right? It's 2001 and 1442. 1442 is taking a little longer to get to PoC, but 2001 is ahead right now. So that will be the first followed by 1442. These are the two in clinical development. 1342, we are not doing any more clinical work, but we are actively looking for partnerships around 1342.
And are there any other assets which are any preclinical assets that you're looking to build out the sort of to grow through as we go along?
Near term, it's just these three that we are talking about, Nitin.
Okay. And secondly, Glenn, on the U.S. Now, obviously, you talked about the fact that it's become like a less than half quarter of the business now. Again, strategically, how do you look at U.S. now? What kind of investment in the generic part that you're loo king to make? And where do you see opportunities, if any, in the U.S. business there?
I mean, clearly, on the U.S. business, the near term, the next 2, 3 years will be driven by our respiratory launches and the injectables coming out of Mon roe. These are the 2 drivers, right, that we have for the U.S. business. Following that, we have some sole FTFs like Gabapentin Enacarbil, Beta, Calci foam. So these are some of them. We have a unique position on Axitinib. So I think these 2, 3, there are some very select products, but I think post H2 of this year, the U.S. business should start showing some good traction, right, in the second half of this year and beyond, right, mainly coming out of some of these unique launches, right, that we have for the U.S. business.
And, Glenn, what are timelines of some of these launches that you mentioned?
So H2 is broadly what I can give you, Nitin. I can't be more specific than that.
Okay. And lastly, Mani sir, on the cash flow, what is the outlook for the working capital last year? Where do we see ending the year end at?
So Nitin, as you recollect, even during the Q4 call, we had guided that we would be closer to 70 to 75 days. So as of now also, we are at about 62 days. So I believe that there could be some uptick because as you can see, the business is also growing, and we may have some little more increase in the working capital side, especially on the receivable side. Yes.
So all in all, we should 70, 75 days is what we should work through on a sustained...
Yes. 70 to 75 days would be ideal that you should work through. Yes. That's correct.
As there are no further questions, I now hand the conference over to Mr. Utkarsh Gandhi for his closing comments.
Okay. Thanks, Lizanne. So before we end the call, we'd just like to state that the discussion materials provided during today's call, including information, statements and analysis made describing company's or its affiliate's objectives, projections and estimates are forward-looking statements. These are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause our actual outcomes to differ. No representation of warranty, either expressed or implied, is provided in relation to these discussions, and this should not be treated by the recipients as a substitute for the exercise of their own judgment. The company also does not undertake any obligation to update or revise any forward-looking statements. With that, we can close today's call. Thanks a lot for your participation.
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.