On the guidance of 10% to 12% revenue growth - given the slowdown in India and the U.S. probably starting growing towards the second half, isn't 10 to 12 looking stretched?
So overall, the business continues to do well. ROW is strong. Europe, we are seeing strong growth. These 2 geographies are strong. I mean ROW corrected for currency grew 10-plus percent in this year -- in FY '25. And we expect it to accelerate even further in this coming year with some big launches. So all in all, we feel pretty comfortable with the 10% to 12%.
Assuming you're able to do an ISB 2001 licensing deal, what's the next step? Will you step up investments in IGI, reinvest in other businesses or give out dividend?
So the only visibility I can give you right now, Saion, is that we will cover -- I mean, from the licensing deal at least the next 3 years of IGI expenditure will get more than covered. So we are burning about $70 million a year. And we'll keep it around the same level over the next 3 years. And then after that, obviously, IGI, we've always said that they have -- the vision is eventually to IPO that company.
On the India business, what would be the contribution of remo and teneli to Glenmark's current diabetes portfolio in FY '25?
So as I said, I don't have the precise numbers, but teneli and -- about 60% should have come from these 2 assets, right, along with their extensions.
On GHSA, what's the loan to GHSA and the equity contribution to GHSA as on 31st March '25?
Loan to GHSA from Glenmark, as you can see in the balance sheet, we have about $600 million, that's it. That's the investment that we have.
How do you explain the deviation between the IQVIA numbers and our primary sales for the India business? Where does the disconnect come through?
I think the -- we've listed out 3, 4 different things including taking out some tail-end brands, which are low margin based. All that is impacting the reported growth in Q4. But I think going forward, the overall India will be a strong -- the growth will be strong.
On the IGI deal with the ISB 2001 deal, do you have a broad time line in terms of by when we can conclude this?
So all I can say, Nitin, is it should happen pretty quickly.
With respect to the plant which is shut, what is the sort of operational cost saving that will also help in margin improvement in FY '26?
But as we guided already, we would be at about $70 million close to where we are. There will be some benefit, but I can't really quantify a very big benefit out of this because it's doing well, and we actually want to -- there will be costs. So by saying that I saved something, but I have some other CDMO cost, may not be the right way to explain that.
On the cash generation guidance of INR300 crores to INR400 crores - can you help us bridge the gap between the EBITDA margin and the cash generation? Is this free cash generation?
The number of days will be the same, just to put it in perspective. Obviously, we guided to about a 19% EBITDA. We could get into detail, but just to say that, that is one, then you'll have your cash tax, you'll have your working capital, you'll have some asset additions. So all put together, that's how we arrive at the numbers.
On the EBITDA margin guidance of 19% to 20%, I'm not pretty clear on the drivers. RYALTRIS adds USD 20 million, IGI investment is $70 million, and U.S. critical launches contribute only from H2. What exactly drives this margin improvement?
I think we've already discussed. See, RYALTRIS will give you some benefit. We discussed about the 2 launches in the U.S., which are the big drivers. Keep in mind, U.S. margins have been suppressed, right, because of the lack of any launches. Even the launches that we are making in Q4, the margin profile will start improving from Q1. So that is one thing. Then after that, we discussed about R&D spends. Overall R&D spends, some leverage coming out of that towards the overall margins.
On the R&D side, can you quantify what kind of R&D spend you expect for FY '26?
Not at this point. We've given an overall number of 7% -- roughly around 6% to 7%.
On the Monroe asset - given $150 million investment is largely on injectables. With local manufacturing focus in U.S., is there any possibility to get write-backs on the expenses for unviable lines?
Nitin, our goal is to get that plant up and running, functional and operational. We have some good filings coming out of there. And we truly believe that longer term, this portfolio will do well for us in the U.S. market.
Given the ANDAs and executive order in the U.S., have you been told by global pharma that valuations for all the originated products might recalibrate? Any update on this?
Well, I think the -- I mean, given the executive order towards the most favored nation clause, I think there's still -- clarity still needs to evolve on that whole thing. But our view internally is that the major impact will be for brand pharma as compared to generics.
Nothing on the products like the companies like IGI are working on, something like ISB 2001?
IGI is still at a very early stage. They're not commercial. So there's a long way to go for commercialization.
How do you see the investment going forward in IGI? Will the investments be led by the partner or will you also put in some money?
So we've clearly said that post closing a deal, we will -- IGI will be self-sustaining at least for the next 3, 4 years. And we will not need to invest anything in IGI post-closing a deal.
On your diabetes portfolio in India - it's a space where competition is rising up, but the kind of weakness we are seeing in the portfolio is a bit difficult to understand. What is leading to such muted performance?
If you look at the history in diabetes, Glenmark was a nonexistent player in this space. And we launched 2 major molecules. One is remogliflozin and the other one is teneligliptin. We were able to make significant headway in both -- with both these molecules till dapagliflozin went generic and sitagliptin went generic. And at that point, we were unable to sustain the growth. What we've done now is we've transitioned from there to launching Lirafit, which is liraglutide. We also have sitagliptin. We also have empagliflozin, the 3 main molecules in diabetes. And the next step will be the launch of semaglutide.
Apart from these 2 products, remo and teneligliptin, can you say like your base products are broadly stable?
So the base is stable. At one point, these 2 products contributed almost 60% of the diabetes franchise, just to tell you how big they were, these 2 molecules. So the erosion that we saw was not -- we were struggling to sustain that.
Any indication like how Lirafit is doing - it has been launched for a couple of months. Any initial number or indication?
So I think Lirafit, overall, the growth is good. The molecule is doing well. I mean we've had some challenges in supply. And we still continue to face some challenges. We are hoping that in Q1, some of those will be behind us, and we will get full supply, and then we'll be back in terms of sales.
On your ISB 2001 asset - you have started dose expansion studies in April. How many patients are you planning to recruit and what kind of cost? Can you complete this phase without any deal?
So while we are doing the dose expansion, look, the clinical development doesn't stop. This is a -- speed is of the essence. In parallel, we are in advanced discussions with multiple partners, all big pharma partners. The expansion phase is 80 patients in total, 3 different dosing groups that we've initiated. And it's being run in multi-geographies. So U.S., Europe, Australia are the 3 main geographies where we are running the trials.
On your Pithampur plant - anything to share in terms of resolution part or anything you heard from the FDA?
So we are still in discussions with the agency on what this means and how this will play out. But from a commercial perspective, we have no launches coming out of Pithampur, a minimal amount. So there's no real impact on the business. And most of our launches, as you know, is coming out of Aurangabad, mainly the respiratory launches.
Is there any target action date for the nasal spray or generic Flovent? Or are there any pending CRL? We have also seen some delay in the filing of the remaining 2 strengths for Flovent.
So Saion, as you know, Flovent is an extremely difficult product. So on the 44 strength, we are expecting approval towards the end of Q2. On the nasal spray, we expect in the second half, we will launch the product, second half of FY '26. The remaining 2 strengths, 110 is likely to get filed in the first half of this year, towards in Q2 sometime. And 220 maybe following that towards the end of second half of this year.
What would be the global sales for RYALTRIS from Glenmark's perspective, primary sales in FY '25 versus '24?
So we did $80 million last year. And this year, we are expecting to cross $100 million in sales for RYALTRIS.
On the Aurangabad plant, what's the status of compliance? When was the last inspection?
So Aurangabad was inspected in September 2024, and we got 0 observations essentially.
The guidance on margins and particularly the cash generation - I'm presuming that's not factoring in any IGI deal that one would do, right?
That's correct. This is only the core business.
What would be our tax rates going forward?
Yes, it will be about 21%, 22%. As you can see, Anil, last year also, we came down to 25%. So we anticipate to go down.
On the working capital side - last 2 years we've seen the balance sheet not throwing free cash flows. Working capital seems to have got elongated this year. What would be ideal where you settle down?
Actually, if you look at it in this year, our overall net working capital comes to about 104 days. This very much is in alignment with all our peers, who are like global companies. So like our inventory is about 83 days and peer is about 75 to 80 days. Working our -- debt receivable is about 92. Peers are about 85 to 95. So I think all in all, I think these are the levels at which it settles down.
On the guidance of 19% to 20% EBITDA margins, what will be the drivers for the margin improvement that we're looking at without the licensing deal?
So obviously, RYALTRIS is a big driver. I mean, RYALTRIS will be a big driver. R&D, we can get some efficiencies out of R&D. I think these 2 are the immediate things that of course -- and we have some big products, whether it's Flovent, whether it is the nasal spray that we will launch in the U.S. All these will help drive up the overall margins of the business.
Going forward, apart from strengthening the diabetes portfolio, what other strategic areas you have in mind to grow the India business?
See, obviously, the BeiGene launches, which are happening in Q1, maybe June or early July. Those will be huge launches. Both tislelizumab and zanubrutinib both should launch, early July. And that will be a big driver to the growth near term. In addition to that, we continue to file some good respiratory products, which we are hoping to drive our overall growth.
On the India side, share number of MRs and where do we intend to take that in FY '26?
So the number of -- the sales force, we are not expanding. It's about 5,000 -- somewhere around 5,000, 5,500 reps.
On your plants - except Aurangabad, you have pending issues from the FDA in terms of GMP compliance. What are you thinking on the resolution part for Monroe and others?
So I think Monroe, we should get inspected pretty soon, okay, anytime. So that's one update. On the Goa side, we did a meeting with the FDA, and we're waiting for them to come and inspect us, okay? So that covers all the 4 plants, right?
On the Monroe plant - last year, you impaired part of the plant focusing on the injectable. What is the value which is remaining for the plant?
So today, we would have an investment of about $150 million. So we did -- if you remember, we did impair about $100 million plus. So that's where we are in.
On your interest expense during the quarter - we have again seen some pickup there. What is happening?
Yes. So Damayanti, like it's about INR66 crores or so, about INR5, INR6 crores is basically due to the -- whatever interest you get on the leases. So balance, it's gone up a little bit because of the increase in the debt. But I think coming year, what we have guided already. So based on that, we could see close -- it coming a little lower, yes.
On Zetia antitrust, are there any pending litigation or any other contingent liabilities that we should consider?
So -- Saion, as I've given in the note, there were 4 opt-out cases, 3 have settled. There is just one more left, okay? That's it. One party is still left.
On the BeiGene assets that will be launched in India, what's the market size? How should we sort of map the market and sales potential?
So the current -- the PD-1, PD-L1 market is over $200 million in India right now. So it's a very large opportunity. And we think we can actually get a good share of that in the near term with tislelizumab. And in addition, the BTK product that BeiGene, that we've in-licensed, is actually best-in-class, has got some great clinical data.
On the U.S., barring the Flovent 2 new filings, how are you thinking about investments in the U.S. on a going-forward basis? Any specific areas or what kind of opportunities do you see?
So we are basically going -- investing in 2 areas. One is respiratory, and the other is injectables, right, out of Monroe. These are areas where the bulk of our research efforts are going.
In the respiratory barring Flovent, when do you see the next set of filings coming through?
We have a host of filings. We have one more MDI getting filed in Q2 of this year outside of the 110 and 220 this year. So we'll have 3 MDI filings this year. We will have at least 2 or 3 nasal sprays getting filed this year.
On the PD-L1 market - currently who are the principal players in that market? And what gives you the confidence for the levels that you're looking at?
So the 2 big players are, KEYTRUDA is the biggest there, which pretty much dominates the market. And then we have nivolumab of Bristol. These are the 2 big players in the market.
Would you be open to using the Monroe plant to expand in light of the U.S. requirement for domestic manufacturing? Or would your interest be limited to only injectables?
So currently, we want to first get the plant cleared and reinitiate manufacturing of the injectables. That's our first goal. And we have some good filings currently underway from that facility in addition to the products already filed and approved. So I think the goal is first to get the injectable portfolio up and running before we look at expanding into other areas.