BBL showed lower EBITDA growth vs revenue for the year — is this pricing pressure? How should we look at this from FY26?
As the launches do come in, the incremental gross margin on those launches is going to be higher than the existing business. So some kind of operating leverage as well as gross margin improvement is expected. We're not giving the guidance, but directionally, you are right. Core EBITDA reflects, to some extent, the investments that we have to make in the Opex. And yes, there has been some price pressure. But going forward, like what we said, once the new launches do kick in, the incremental gross margin and EBITDA contribution will look quite healthy.
Adalimumab — 4 products have hit USD 200M. Is US a material contributor for Adalimumab?
For Adalimumab, we haven't specifically broken down, Harith, every product by region. U.S. is a sizable portion for our business. It's about 40% of our overall sales. Adalimumab has been a product, like Matt was referring to, a lot of it depends on how long the originator stays on the formulary. We have seen the originator product, in this case, stay on longer than expected, which is why you have seen that biosimilars in general have not gained as much market share as we've seen in Oncology, where it's over 80% that we have seen biosimilars have adoption already.
Are innovators withdrawing insulin SKUs across more markets beyond India?
Again, I refrain from talking specifically about competition, but these are public events where, you are right, there are examples where innovators have withdrawn products. I mean the India example that you've just cited is true. And then there are other geographies as well where we see it happening. But that certainly creates a large opportunity for Biocon Biologics, because we are already present in many of these countries. We sell in over 80 countries at this point in time, and we see that demand increasing already.
On Stelara biosimilar: with over 70% market access, what kind of market share is Biocon building and how is pricing playing out?
We have over 70% market access with the payers in the U.S. at the beginning of the start. With that comes the opportunity for us to continue to pull the product through in the U.S. We are very bullish on our market share. We haven't really been able to state that directly yet as we're starting to work with physicians and pulling it through. But we have over 100 million lives that are covered in the United States. The pricing situation remains stable. We're certainly in a good position. The pricing remains stable at this point as we go through the rest of the year. We don't see much changes in compression in the price points in the net selling price going forward.
Has Bevacizumab launched in US and what's Aspart launch timeline?
On bBevacizumab, we do have positions with Bev and approval. So, you will be seeing that sometime in the first half year of a launch. As you know, with Aspart, we're still waiting on approval, but we are bullish on expectations of having that approval here in the first half and be ready to launch. As you know, we have a tremendous franchise with our biosimilars already in diabetes with our insulin Glargine. And our customers are very anxious in engaging with us as Aspart becomes available.
What's the current BBL debt position, working capital, inventory days vs last year?
Our working capital position has substantially improved compared to last year. Our receivables look quite healthy. The number of days across each markets vary, but roughly, they are around 90 days in terms of the credit that we offer to customers. Inventory, in fact, has come down dramatically compared to last year. So, the net inventory as on 31st March is about USD 390 million. In terms of the forward days, it's less than about 280. Net debt is about USD 1.1 billion as on 31st March. And if you normalize for the factoring and advance collections that we have done, it's about USD 1.2 billion. March'24 DIO, days inventory outstanding, was in excess of 400. And as of March,'25, as I said, it's lower than 280.
When should Stelara market share start reflecting in IQVIA data? How long for physicians to pull through?
As you know, the U.S. payers have different timing. You're going to see some of the U.S. payers when they decide to not cover the Stelara innovator. Some of this will be starting in July, then some in September, October, and then finally, the majority of them will not be covering the innovator in January '26. As you start looking at the IQVIA data, you'll start seeing sales already. They've started. And as we go through the remainder of this calendar year and then into the Biocon remainder of fiscal year, you'll start seeing more and more market share as the innovator is not covered by the payers. And remember in this, too, as we reported, we are covered by every major U.S. payer. When I say that, that's your Express Scripts, your Optum, your CVS Health, the major ones.
When is Liraglutide launching in US? Will generic Revlimid revenues be lumpy until January 2026?
Neha, the launch in U.K. was in quarter 4. Of course, we'll be supplying additional volumes in this quarter. And launch in Europe is planned in the second quarter, while we are trying to get the supplies to our partner, Zentiva, in the first quarter. And as far as U.S. is concerned, as you know, we had mentioned earlier that there were certain queries which we have responded to. The facility of Biocon Biologics, from where the product was filed, has been cleared. Again, we have responded to the FDA. And we have a target action date during the second half of this calendar year. And of course, subject to the approval, we will be ready to launch the product immediately after that. And as far as the generic Revlimid is concerned, you're right. We had a settlement with the innovator where we were allowed a certain market share, and a large part of that market share has already been serviced in the quarter 4. So to that extent, revenues will be lumpy before the market opens up in Jan '26.
Rationale for Civica partnership — why supply drug substance for local US manufacturing of Aspart?
The idea was to see how we can get product close to customers as much as possible. And the relationship that we've essentially done with Civica Inc. is where we have local manufacturing of drug product within the United States. So a large part of it is also to see how we can localize manufacturing in the U.S. That's one. Two is it does give us access to those set of customers that Civica is able to access. And that income, that essentially is not competitive to Biocon Biologics and our brand but essentially is accretive to what we are trying to do there. And three, I think the cumulative effect of having more than one brand has been already a proven commercial strategy where we've seen the benefits of this in several markets, and we intend to see how we can bring our insulins to more patients across the world.
On Pegfilgrastim at 30% market share — have competitor supply issues normalized? How should we think about market share trajectory?
the management of ASP is something that needs to be done very carefully, because ASP and market share are inversely proportional. So you could essentially move very quickly, gain market share, but then it comes at the cost of ASP, which makes you unattractive to the end provider. And which is why you've seen us steadily grow the market share, and there's not been a rapid movement in this pickup. Now as competitors try to win market share, one of the strategies is, of course, discounting the ASP, and that leads to them not being available in the market anymore. That's where our market share has really gained.
On Aflibercept: what's the profit-sharing arrangement and do you have exclusivity?
We've not specifically disclosed contractual agreements and understandings with our customers. Needless to say, this is a product that we will first be launching in Canada in July of this year, where we will be the first to launch. So we're looking forward to that launch. We are also looking now clearly to a very risk-free, I would say, date for 2026 for aflibercept in the U.S. So I would say on both counts, we are at a place where we have certainty of when and where the product will be launched. Now how these will eventually translate in terms of exclusivity that you talked about, I think we are the first biosimilar to have been approved. There is, of course, others who have launched. But we have this position where our product will be approved as an interchangeable on approval.
Yesintek has the strongest formulary position among Biocon's US launches — fair to expect better initial market share?
Certainly fair to expect, Surya. We've not guided anything specific, but we're very happy to see that the product has been very well received by all major commercial players in the U.S. market. And I should also give another piece of information there that for Stelara, more than 80% of the market in the U.S. is commercial. And when you have 100% coverage on all commercial payers, then of course, it is fair to say that you will see a good uptick as compared to what we saw for Hulio.
How sustainable is USD 200M revenue for each of the 4 products including insulin given competition?
I do want to respond to it with fact again. We talked about insulin as one of the products. We are seeing in many countries, the innovators also starting to pull out. So clearly, that demand is exceptionally high. And to give you a sense from an established product perspective, that is a product we launched in 2004. So if you look at it, it's more than 20 years and the product continues to grow, and we expect to see even greater demand for insulin. In a year where we did not have new product launches for biosimilars, the business continued to grow, not just year-on-year, but also sequentially. And you've seen a very strong core EBITDA and EBITDA growth.
On R&D and capex: will R&D spend moderate further as a % of sales? What's capex outlook for next year?
On the Capex side, like what you said, Surya, we expect to spend about USD 100 million over the next couple of years. After which, it's expected to get moderated down. Large part of this money will go to enhance the capacities in Malaysia, which, for us, is very rewarding given the global demand that we are seeing for the product. For Generics, again, we'll be looking at another USD 50 million next year. And I think with that majority of our ongoing Capex programs come to an end and it will be only small bit of maintenance Capex from FY '27 onwards.
On QIP/private placement plans — amount, use of proceeds, timeline?
what we have announced is that we intend to raise INR 4,500 crores through a combination of QIP and private placement, and we have sent out a shareholders' notice last week towards the same. We have started discussing with our bankers and investors and lawyers about the whole process. We expect to complete the first tranche, which we will decide the quantum of that first tranche in a few weeks. But this first tranche is expected to be complete by middle of June. And proceeds of the fund as you know, Biocon has certain financial obligations towards the commitments and the put options from the structured debt that we had from the investments in Biocon Biologics. So the proceeds of the fund will primarily be used to meet these obligations.
Is Biocon looking to clear all structured instruments from its balance sheet?
No, not in its entirety. I think the investors, of course, have a put option. So for those investors who have exercised their put option, we will look at giving them an exit, but it doesn't mean that all the investors are looking at exercising the put option.
Was Q4 Generics performance driven by Lenalidomide? Will this trend normalize?
As I had indicated earlier that we did have launch supplies for generic lenalidomide in quarter 4. And whatever allocation we had from the innovator for the first few months of the launch, we have supplied majority of that in quarter 4. We do still have some volume that will be supplied in FY '26, but we have many more launches coming up in FY '26. So, as I had mentioned earlier that liraglutide in Europe would be launched in quarter 1 and quarter 2. We also expect to launch liraglutide in the U.S. We are expecting approval for generic Copaxone in the U.S. We recently announced the approval of generic Everolimus or Zortress in the U.S. All these launches will drive growth.
What is insulin capacity utilization and how does Malaysia drug product expansion change it?
one of the things that we've refrained from giving is the specific insulin capacity for competitive reasons. So it would not be fair to talk about what exactly our capacity is. We do have made comments to indicate what our capacity expansions look like. And we've talked about the fact that at this point in time, we've just brought online another drug product facility in Malaysia, which increases our capacity of manufacturing drug product twofold. So it's a doubling of capacity that we have just completed. We believe that outside of the originators, we would be amongst the largest player of insulins, the largest manufacturer of insulins and the one which is fully integrated.
On GLP-1 — with most capex settling, are there plans to expand GLP-1 capacity? What's existing GLP-1 device capacity?
we have already invested in a large-scale drug substance capacity of GLP-1s, which was capitalized in FY '25. We have the new injectable facility for GLP-1s, which will be commissioned in FY '26. Now when you really look at the market opportunity for GLP-1s, there are 3 large drugs, as you are all aware, Ozempic or Semaglutide, Tirzepatide and Liraglutide. And liraglutide is the smallest in terms of the market revenues and the volume, but we have Semaglutide, which goes off patent in the U.S. and Europe starting 2031. And then you have Tirzepatide, which opens up after 2036. over the next 2 to 3 years, we don't need capacities for the demand that we expect in the near term.
Is there anything still pending for Aspart US approval?
There is nothing that is pending. We have a goal date coming up in a month or so. And then once the goal date is reached, we should receive the approval on or before that goal date. That's our expectation. Of course, we have to wait for the decision of the agency, but we are quite hopeful.
Where does Copaxone stand with US FDA queries?
We had indicated earlier, there were no outstanding scientific queries. It was only pending inspection outcome of the biologic facility, which got cleared in December. We have responded to the FDA. We again have a new target action date in a few months, a couple of months. So we are hoping to receive an approval by then.
Can you name the 5 new biosimilars planned for launch in next 12-18 months?
The 2 products that we just talked about even in the opening remarks, actually, Kiran did cover all of them. We've launched Stelara biosimilar, which is one of them. The other one is we've got approval for bevacizumab. We talked about Aspart just to Amey's question. So that's the third one. We discussed the Aflibercept settlement and the launch in July. We launched that in Canada. We have a clear launch date in the back half of '26. So that's the fourth one. And Denosumab was another product where we've just received approval from the European authorities, the CHMP positive opinion. We look to get that approval in a couple of months, which is the procedural piece for EMA. FDA approval is also expected by the end of this year. So these are the 5 products we expect to launch in that 12-to-18-month window.
On Aflibercept competition — will there be limited competition when Biocon launches in second half of 2026?
the first piece is that we see this as a very large market. Globally, this is a $9 billion opportunity. So it's a very large asset, and we are very well placed. We have a risk-free position. So we don't really see and discuss what competition would do when they launch at risk and the outcomes and consequences of that.
The Board has constituted a committee to evaluate restructuring/merger of BL and BBL — any color on the thought process?
given the market volatility that we are seeing on the IPO front, I think the Board was of the opinion that we should look at other strategic options, which also includes evaluating a merger. So at this point in time, the Board has constituted a committee. We will evaluate all strategic options and then get back to you in a few months with what the committee recommends to the Board.