Joining us on this call to discuss Biocon's fourth quarter and full-year results for FY2025. I'm Saurabh Paliwal from Biocon's Investor Relations team. Before we get started, let me introduce the management team on this call. We have today Biocon Chairperson, Dr. Kiran Mazumdar-Shaw; Mr. Siddharth Mittal, CEO and MD of Biocon Limited; Mr. Sreehas Tambe, CEO and MD of Biocon Biologics Limited; Mr. Peter Bains, CEO and MD of Syngene International, along with other senior management colleagues across our business segments. A few housekeeping points. We will start the call with opening remarks from Kiran, which will be followed by an interactive Q&A session. All external participant lines are muted and in the listen-only mode. There will be an opportunity to ask questions after the opening remarks conclude. If you need to ask a question, please select the Raise Hand option under the Reactions tab of your Zoom application.
We will call out your name and unmute your line to enable you to ask the question. Please note that this webinar is being recorded. The recording will be made available on our website within a day, and the transcript will be made available subsequently. Before we begin, I want to remind everyone about the safe harbor related to today's call. Comments made during the call may be forward-looking in nature and must be viewed in conjunction with the risks that our business faces that could cause our future results, performance, or achievements to differ significantly from what is expressed or implied by such forward-looking statements. With this, I would like to turn the call over to Kiran for her opening remarks. Over to you, Kiran.
Thank you, Saurabh, and good morning, everyone. I'm delighted to return to hosting Biocon Limited's quarterly earnings calls. I'm pleased to provide a business and financial overview of the Biocon Group's Q4 and full-year FY2025 performance. Before diving into the details, I'd like to share a few opening thoughts. Building on our Q3 performance, our three divisions—generics, biosimilars, and research services—ended the financial year on a strong growth trajectory. Let me start with key highlights for Q4, and these include the appointment of Peter Bains as MD and CEO of Syngene International, the global launch of our first GLP-1 formulation, Liraglutide, in the U.K., and the introduction of Lenalidomide and Dasatinib in the U.S. The launch of Yesintek, or biosimilar Ustekinumab, was an important launch, which is one of the first biosimilars to Stelara in the U.S., and the fifth product from our portfolio to enter the U.S. market.
The settlement with Regeneron to secure a market entry date for Yesafili, which is our biosimilar Aflibercept in the US, is expected to be no later than the second half of 2026 now. Syngene's acquisition of a biologics manufacturing facility in the US positioned us to meet the rising demand for biologics CDMO services, and this time from a US base. The group achieved a robust 15% year-over-year and 16% sequential growth in operating revenue on a like-for-like basis. That is, after excluding revenues from the India-branded formulations unit, which was reflected in Q4 of FY2024. This quarter's performance was bolstered by strong growth in generics, steady progress in biosimilars, and ongoing traction in research services. Moving to discuss the financial highlights. For Q4, revenue from operations reached INR 4,417 crores, reflecting a solid 15% year-on-year increase on a like-for-like basis and a 16% sequential growth.
This growth was driven by a 46% year-on-year growth for generics, 9% for biosimilars, and 11% for research services. Sequentially, all segments reported growth. Generics particularly was up 53%, whilst both biosimilars and research services were up 8%. Core EBITDA for the quarter stood at INR 1,363 crore, a 16% increase from last year, with a healthy core operating margin of 31%. R&D investment for the quarter was INR 231 crore, accounting for 7% of revenues, which is, of course, excluding Syngene. Reported EBITDA for Q4 was INR 1,115 crore, which is a 16% year-on-year growth on a like-for-like basis. Profit before tax, excluding exceptional items, was INR 466 crore, a strong 45% increase on a like-for-like basis. Now, moving to full-year numbers. For the full year, revenue from operations totaled INR 15,262 crore, which is a 10% year-on-year increase on a like-for-like basis.
Group core EBITDA for the year was INR 4,264 crore, with a margin of 28%. EBITDA reached INR 4,374 crore, reflecting a 3% year-on-year growth on a like-for-like basis, with a margin of 27%. Reported net profit for FY 2025 was INR 1,013 crore, which is a significant turnaround when considering the performance on a like-for-like basis. I would now like to discuss our business performance in a segmental manner. Let me start with generics. Q4 has been the strongest quarter for the generics business in FY 2025, with revenue from operations reaching INR 1,048 crore, up 46% year-on-year and 53% sequentially, driven largely by the sale of launch quantities of Lenalidomide. The launch of Liraglutide in the U.K. and Dasatinib in the U.S. also boosted revenue performance this quarter. In addition, we received approvals for liraglutide in the E.U. and everolimus Zortress tablets in the U.S.
We also commenced supplies of tacrolimus to China, where our partner is expected to initiate commercialization in the first quarter of FY2026. For the generics business, EBITDA for the quarter was INR 243 crores, up significantly from last year and the previous quarter, bolstered, as I mentioned earlier, by the lenalidomide launch in the US. EBITDA margin stood at 23% this quarter. For FY2025, revenue from the operations was INR 3,017 crores, reflecting an 8% year-on-year increase. R&D investments rose to INR 286 crores, which is about 9.5% of segment revenues, aimed at driving future growth. Our peptide portfolio, especially GLP-1s, will be our key drivers for future growth. EBITDA for FY2025 was INR 377 crores, with EBITDA margins at 12%.
EBITDA performance for this year reflected pricing pressure and higher operational expenditure linked to new plant capitalizations, namely the peptide API facility, the Vysak fermentation capacity expansion, as well as the U.S. cranberry facility. Now, coming to biosimilars. In Q4, Biocon Biologics marked its first anniversary as a fully integrated global biosimilars company with a footprint in 120 countries. Key highlights include key product and site approvals from global regulators, including U.S. FDA and EMA. We received U.S. FDA approval for Jobevne, our biosimilar Bevacizumab, and a positive E.U. CHMP opinion for biosimilar Denosumab. Strong commercial momentum was delivered, with significant increase in market share across geographies. I would particularly like to call out Fulfilla, which is our biosimilar Pegfilgrastim, and Ogivri, our biosimilar Trastuzumab, which registered market shares of 30% and 26%, respectively, in the U.S. market, which is a twofold increase from last year.
We had a successful launch of Yesintek, which is our biosimilar Ustekinumab, with broad formulary coverage and physician adoption. Also important this quarter was our announced partnership with Civica Incorporated, a U.S.-based not-for-profit supporting affordable insulin access for people with diabetes. We are witnessing a surge in global demand for our insulins. Given our global-scale manufacturing capacities, we are well placed to capitalize on this large opportunity. The Biocon Group is also, if I may say, uniquely positioned to address the growing global burden of what we describe as diabesity through its portfolio and pipeline of both insulins and GLP-1s. Now, moving to financials. Biosimilars revenue for Q4 was INR 2,463 crores, which is a 9% year-on-year increase on a like-for-like basis. This growth translated into an EBITDA for Q4 FY2025 at INR 540 crores, representing a healthy EBITDA margin of 22%. R&D investments for the quarter were at 6% of revenues.
Full-year revenue was INR 9,017 crores, up 15% year-on-year, with four biosimilars recording revenues of $200 million each, demonstrating strong payer and prescriber confidence in our products. Reported EBITDA for the full year was INR 3,028 crores, excluding a one-time gain from the BFI business divestment. EBITDA for the full year was INR 1,971 crores, with a margin of 22%. This R&D investments for the year were at 7% of revenue, which will fuel mid to long-term growth. Now, lastly, moving to research services. Syngene ended Q4 with revenue from operations of INR 1,018 crores, 11% year-on-year increase. Quarterly operating revenue crossed the INR 1,000 crore threshold for the first time. EBITDA was up 9% year-on-year and 20% sequentially to INR 363 crores, with EBITDA margins at a strong 35%. The acquisition of a state-of-the-art biologics facility in the US enhances our capabilities in the global CRDMO market and creates our first US manufacturing footprint.
For FY2025, revenue from operations grew 4% to INR 3,642 crores, aligning with guidance following a challenging first half. EBITDA stood at INR 1,114 crores, with EBITDA margin at 30%. Let me conclude by saying that, in summary, FY2025 has been a year of consolidation and transition, which has set us up to an exciting inflection point. We are now on a path of accelerating growth with a commitment to innovation, digital augmentation, and operational excellence. Thank you, and with this, I open the floor to questions. Thank you, Kiran. We'll wait a moment for the question queue to assemble. Ladies and gentlemen, to ask a question, please select the raise hand option in your Zoom application. We'll start the first question with Ananthi Garai from HSBC. Please go ahead.
Yeah, hi. Good morning, and thank you for giving me the opportunity.
My first question is on your biosimilars Stelara, where you recently updated that you have gained access with leading formularies in the U.S. Just want to understand what kind of market share you are building in in view of this update, and if you could also comment on how the pricing scenario is playing out for this particular market. Thank you.
I would hand this over to Matt to explain and answer your question, Babil.
Thank you, Kiran. Appreciate it. As you know, we've had very successful market access. 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 trying to work with physicians in pulling it through, but we have over 100 million lives that are covered in the U.S. It's one of our most successful market access to date. This allows us to continue to work with physicians, healthcare providers, and pull this through. As we go through, we'll continue to update you on our abilities and successes that we're having, but we remain very bullish on our opportunities as we go through the remaining quarters because of how we're set up with all the major payers and having that access position.
Sure. If you could also comment on the pricing scenario, please.
Sorry, I'm not sure why my video is not working. I apologize. There we go. The pricing situation remains stable.
We certainly are in a good position, as you know, in the U.S. It is somewhat the economics, but clearly, the customers have seen the science behind this. Also, we've built tremendous relationships with the payers and also the healthcare providers. So 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 and the net selling price going forward.
Sure. My next question is on two other products, Bevacizumab and Aspart. So Bevacizumab, have you launched in the U.S., or it's yet to be launched? And then what kind of timeline we are looking for Aspart launch in the U.S.?
Kiran, would you like me to take that, or Shreehas? Either way is fine.
You can continue, Matt.
Sure.
Sorry, Shreehas, did you want to say something before I jumped in?
Go ahead, Matt. Okay.
On the Bevacizumab, we're ramping up as we speak. We do have positions with the BEV in approval, so you'll 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're 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 and engaging with us as Aspart comes available. On the Bevacizumab, let me just touch base one more there. On the Bevacizumab launch, as you know, we have an incredible oncology portfolio, as Kiran stated. We have over 30% in Fulfilla, 26% in Ogivri.
This will be a nice addition to our oncology portfolio and will be well positioned with our sales force and being able to not only work with the payers, which will have a strategic initiative of getting access, and then we'll be able to work with the relationships, which we've been very successful with oncologists, to be able to pull that through in certain channels.
Sure. My last question is on financial position of Biocon Biologics. If you can comment on the current debt position and also how are the working capital looking compared to last year. If you can comment anything on, say, inventory days for Biocon Biologics or on the receivable fronts, that will be helpful. Thank you.
Maybe Kedar would like to take this.
Yeah. Hi. Hi. Good morning. Ananthi, our working capital position has substantially improved compared to last year.
Our receivables look quite healthy. The number of days across each market is varying, but roughly there 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. The net inventory as at 21st March is about $390 million. In terms of the forward days, it is less than about 280. Both inventory, receivables, and other parts of working capital have substantially improved. Net debt is about $1.1 billion as at 31st March. If you normalize for the factoring and advanced collections that we have done, it is about $1.2 billion. I think compared to March 2024, March 2025 position for net debt, inventory, and receivables look quite healthy. We will continue on this improvement journey.
Sure, Kedar.
This net debt is excluding the structured instruments, right?
Yes, yes.
This is the, yeah, this excludes the structured instruments. Correct.
Okay. Just like on the inventory days, you said $390 million inventories, but on a forward basis, it's around $280 million. Just in terms of days, how does it translate? If you can just compare it against FY2024 numbers. Thank you.
Yeah. March 2024 DIO, days inventory outstanding, was in excess of 400. As at March 2025, as I said, it's lower than 280.
Okay. Thank you. That's helpful. Thanks.
Thank you, Ananthi. We'll take the next question from Neha Manpuria from Bank of America Securities. Please go ahead.
Thanks so much, Saurabh. My first question, Matt, on these Stelara comments that you mentioned, that you're working with physicians to try to pull through the market share, realistically, when should we start seeing this reflect in market share trends?
Would this take us two months, three months, much longer than that? Historically, what's been your sense in being able to work? I know this is only the second launch in the physician market, but what's your sense on when we start seeing this in market share trends?
Thanks for the question. Certainly, 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 on January 1 of 2026. As you start looking at the IQVIA data, you'll start seeing sales already. They've started.
As we go through the remainder of this calendar year and then into the Biocon remainder fiscal year, you'll start seeing more and more market share as the Innovator is not covered by the payers. Remember in this too, as we reported, we are covered by every major US payer. When I say that, that's your Express Scripts, your Optum, your CVS Health, the major ones. This will allow us to utilize our tremendous sales force that we have already calling on immunologists, gastroenterologists to be able to pull this through. The expectations you'll start seeing immediately in the information that you can see in the data in IQVIA, and we expect that market share to continue as the Innovator Stelara is not covered as we go through the remainder of the calendar year.
Understood. That's very helpful.
My second question is, if I look at BBL Financials, the revenue growth of 15% for the year versus core EBITDA growth of 10%, when I look forward, is it fair to assume that some of these new launches will help us grow EBITDA better than revenue trends, either because of operating leverage or better pricing? Any color that you can give on why we are seeing lower EBITDA growth, core EBITDA growth, is it pricing pressure, and how should we look at this from an FY2026 perspective?
Yeah. Neha, as you are aware, we do not give forward-looking guidance, but you are right. I think as the launches do come in, the incremental gross margin on those launches is going to be higher than the existing business. Some kind of operating leverage as well as gross margin improvement is expected.
We're not giving the guidance, but directionally, you are right.
This year, the lower EBITDA growth is purely pricing pressure on the existing products. Would that be fair to assume?
Actually, yeah, you should adjust for the licensing income that we had got last year, Neha. We had in quarter three of last year, if you recall, we had $40 million of profit from sale of brands that was booked as an operating income. If you adjust for some of those items, then you'll get an adjusted EBITDA growth, which will look quite healthy.
No, but I'm talking about the core EBITDA growth.
Yeah. Core EBITDA reflects, to some extent, the investments that we have to make in the Opex.
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.
Okay. Got it. On the generics business, we have launched Lira in the U.K. Any color on when we should expect the launch in the U.S.? In case of generic Revlimid, should we expect it to be lumpy, or would it be a similar trend in the quarters going forward, at least till the time we see patent expiry in January 2026? Any color on the generic business, please?
Neha, the launch in the U.K. was in quarter four. Of course, we will be supplying additional volumes in this quarter.
Launch in Europe is planned in the second quarter, while we are trying to get the supplies to our partners in Teva in the first quarter. As far as the U.S. is concerned, 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. We have responded to the FDA, and we have a target action date during the second half of this calendar year. Of course, subject to the approval, we will be ready to launch the product immediately after that. 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 quarter four.
To that extent, revenues will be lumpy before the market opens up in January 2026, as you mentioned, when, of course, we will be supplying to various customers along with other generic companies who will also be looking at a much larger market share.
Thank you so much, Siddharth. I'll get back in the queue.
Thank you, Neha. We'll take the next question from Harith Ahmad from Avenda Spark. Please go ahead.
Hi. Good morning. Thank you for the opportunity. On insulin Aspart, just a follow-up, the partnership with Civica that you've announced to supply the drug substance. Can you talk a little bit about the rationale for this partnership, given that we have our own product, and also the timelines that we can expect in terms of commencement of supplies here?
Thanks, Harith, for that question.
I think the idea was to see how we can get product close to customers as much as possible. The relationship that we've essentially done with Civica Incorporated is where we have local manufacturing of drug product within the US. A large part of it is also to do with 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 Incorporated is able to access. That income there essentially is not competitive to Biocon Biologics and our brand. It essentially is accretive to what we are trying to do there. 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.
We intend to see how we can bring our insulins to more patients across the world. It is very synergistic with the strategy that we have developed.
The timelines, Shreehas?
From a timeline perspective, given that we will localize this, the sense we have is the initial supplies to make sure that they register the product with the agency would start during the year. Once they have the approvals in place, you would see much more of this starting to realize as they commercialize it.
Okay. Got it. On Fulfilla, good to see the market share in sub to 30%. My question is around some of the disruptions we have seen in this market. One of your competitors had supply issues. Have those issues normalized, and have their supplies restarted?
In that context, how should we think about market shares going forward? Yeah. Sorry that I would not want to specifically talk about competitor positions and their strategies, but let me give you a sense. In the past, also on our earnings call, I have indicated that the management of ASP is something that needs to be done very carefully because ASP and market share are inversely proportional. 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 have seen us steadily grow this market share, and there has 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. There are these one-offs that you refer to where specific competitors could be out of the market, and customers do move on, and we've benefited from that. Once we do that, those customers tend to stay with you. We're not seeing any aberration in terms of this movement. We see consolidation in the market, which we've talked about in the past.
Okay. Last one with your permission, you talked about four of your products achieving sales of over $200 million, and I'm assuming Adalimumab is one of them. In the past, we've had a few challenges in the U.S. with respect to this product. My question is whether the U.S. is a material contributor to the overall $200 million sales that we're generating from this product.
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've 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've seen biosimilars have adoption already. We see that happening during the course of this year. We will see how that changes. Again, being a fully integrated player is very, very important, and that's an area where Biocon Biologics differentiates itself from the market. We are here for this for the long.
We will be watching this space very closely as the success of Stelara Yesintik that we just talked to you about. The confidence is beginning to show where almost all commercial players have got the product on its formulary, which is very contrary to how Adalimumab behaved.
Thank you, Shreehas. I'll get back in the queue.
Thank you, Harith. We'll take the next question from Surya Patra from Philip Capital. Please go ahead.
Yeah. Thanks for the opportunity, Saurabh.
My first question is on the Aflibercept. We have certainly got the launch date for the US market. Could you please share what would be the profit-sharing arrangement there, and do we have any kind of exclusivity there in that product for any period initially?
Surya, thanks for your question. 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. We are 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. 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 are, of course, others who have launched, but we have this position where our product will be approved as an interchangeable on approval, which it was when we got the approval from FDA.
Okay. Okay.
The second point is about the Yesintik. In fact, it looks like the formulary position we have created for Yesintik for the US market is the strongest compared to our earlier product launches. Given that scenario, is it fair to expect a better or better market share position at the initial level itself for Biocon in the U.S.?
Certainly fair to expect, Surya. I mean, we've not guided anything specific, but we're very happy to see that the product's been very well received by all major commercial players in the U.S. market, like Matt just alluded to. I should also give another piece of information there that for Stelara, more than 80% of the market in the U.S. is commercial.
When you have 100% coverage on all commercial players, it is fair to say that you will see a good uptick as compared to what we saw for Julio.
Okay. Just one clarification, sir. The primary insulin, I believe that has also crossed $200 million. When you say that four products have crossed $200 million, am I right? How sustainable is a $200 million revenue size for these products, given the kind of competition we have in the recent past seen for various products? Now the kind of trend change we are witnessing in the biosimilar market of the U.S. in terms of the adoption by the payers and all that, how sustainable is that $200 million for the established products?
Yeah. Surya, I think that is a very fair question. I do want to respond to it with fact again.
We talked about insulin as one of the products. Kiran referred to the tremendous demand that we have seen for insulin across geographies, where, of course, we are seeing in many countries, the innovators also starting to pull out. Clearly, that demand is exceptionally high. To give you a sense from an established product perspective, that is a product we launched in 2004. If you look at it, it is more than 20 years, and the product continues to grow, and we expect to see even greater demand for insulin. Now, come to the other products. We launched the oncology products in the U.S. We were the first to launch Pegfilgrastim in 2018, and we were also the first Bevacizumab to be approved, and we launched that too in that same time frame.
These products have been there in the U.S. now for almost six, seven years, and the market shares that Kiran just talked about in her opening remarks have grown over the course of the last year or so. Clearly, it tells you that the demand is there, the adoption is high, and our product, given the fully integrated nature of our business, continues to grow. 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. You have seen a very strong core EBITDA and EBITDA growth. Kedar did clarify where these things are. I think the important thing to see is that the future clearly is far more exciting than what we have seen before.
Okay. Just last one point from my side, sir, regards to R&D and CapEx one.
Particularly on the R&D, we have obviously seen some rationalization throughout FY 2025 compared to the earlier years in terms of the spend. Given the accelerated growth, what we are anticipating for the biosimilar business, given the kind of new launches, what trend that we should see, whether further kind of a moderation in the R&D spend as a percentage to sales going ahead that we would see, and if you can give some sense about your CapEx plan for the next year.
Let me add. Start, and then Kedar, if you want to add, please do. Surya, I think the first thing is we have clarified even in the past, and the terms of the nature of how R&D spends happen is very closely linked to how product development cycles move.
As products are in, say, in phase three, you will see a far greater spend in R&D as compared to some other quarters. Sequentially, you can see that there is some movement between quarters as products move through development cycles. For the full year, we had given a guidance of 7-9%, and we see that in that range, sometimes towards the lower bound, sometimes towards the higher bound. One key thing to always note is there is no rationalization because the business itself has grown year on year and sequentially as well. The same percentage for a higher revenue number will not indicate rationalization, but a reasonable effort in terms of what we have done in terms of the R&D investments. Kedar, if you'd like to add something, please go ahead.
No, I think you covered well.
On the CapEx side, like what you said, Surya, we expect to spend about $100 million over the next couple of years, after which it is expected to get moderated down. A 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.
This is for the consolidated level, sir? This is for biologics.
Sid can give a consolidated view, but this is for the biologics.
For generics, again, we will be looking at another $50 million next year, and I think with that, the majority of our ongoing CapEx programs come to an end, and it will be only a small bit of maintenance CapEx from FY 2027 onwards.
Gotcha. Thank you. Wish you all the best.
Thank you, Surya. We will take the next question from Pratap Gupta from Alliance Funds team.
Please go ahead.
Yes, I hope you can hear me. Thanks for the opportunity. Just one small question from me is on the recent approvals on your potential capital raise. If the team could elaborate a little more on what the company is looking to do, what timelines we can expect, progress so far, and potential use of proceeds, please. That would be very helpful. Thank you.
Siddharth, maybe you should take this question.
Sure. Thanks, Pratap, for the question. I think what we have announced is that we have intent to raise INR 4,500 crore 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. This first tranche is expected to be complete by middle of June. 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. The proceeds of the fund will primarily be used to meet these obligations. We will, of course, keep the investors updated in terms of the exact quantum and how we will accomplish the fundraiser over the next few months.
Okay. Okay. Thank you. Just as a follow-up, is the company looking to clear the structured instruments in its entirety from your balance sheet?
No, not in its entirety. I think the investors, of course, have a put option.
For those investors who have exercised their put option, for those, we will look at giving them an exit. It does not mean that all the investors are looking at exercising the put option.
Okay. Got it. Thank you. One more, if I may, is on your generics business. What I see is the Q4 has taken a lot of heavy lifting in terms of good performance with the other quarters. Just wanted to get some sense on how do we see is this a quarterly trend, or we can expect more normalization going forward?
As I had indicated earlier, we did have launch supplies for generic lenalidomide in quarter four. Whatever allocation we had from the innovator for the first few months of the launch, we have supplied the majority of that in quarter four.
We do still have some volume that will be supplied in FY 2026, but we have many more launches coming up in FY 2026. As I had mentioned earlier, liraglutide in Europe would be launched in Q1 and Q2. We also expect to launch liraglutide in the US. We are expecting approval for generic Copaxone in the US. We recently announced approval of generic everolimus or Zortress in the U.S. All these launches will drive growth. While you will not see a large component of lenalidomide in FY 2026 because we all have to wait till January 2026 when it becomes an unlimited volume launch by all the generic companies, until then, we will see growth coming in from all the other launches I mentioned.
Okay. Thank you so much. That was it for me.
Thank you.
Thank you, Pratap.
I'll be able to take the next question from Amir Chalker from JM Financial. Please go ahead.
Hi. I'm audible? Yes. Yeah. Thank you so much for giving me an opportunity. During the call, we heard our commentary on the insulin demand, which could increase in coming years. Is it possible to tell how much insulin capacity we are currently operating at in terms of volumes and the utilization for the current capacity and with Malaysia expansion where this capacity would be at?
Thank you. Amir, thanks for that question. I think one of the things that we've refrained from giving is the specific insulin capacity for competitive reasons. 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.
We have talked about the fact that at this point in time, we have just brought online another drug product facility in Malaysia, which increases our capacity of manufacturing drug product twofold. It is a doubling of capacity that we have just completed, and we will go through the regulatory approval process to bring that product to patients. We are also in the midst of the capacity expansion, which will again twofold increase our capacity in Malaysia for our drug substance, which Kedar was referring to in that $100 million of CapEx that we see being invested. A large part of that CapEx was already underway, and we will look to complete that CapEx as we go forward.
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, not just drug substance, drug product, but also the devices that are required to deliver all these insulins and analogs across. A very comprehensive capability and a large capacity to do so as well.
Thank you so much. The second question I have is on the GLP-1 specifically because I heard the comment that on the generic side of the business, except the $50 million CapEx, largely it would be a maintenance CapEx. If we are looking at a big opportunity in GLP-1, are we not looking to put up a capacity for GLP-1 as well? What is our existing capacity for GLP-1 pens? Thank you.
We have already invested in a large-scale drug substance capacity of GLP-1s, which was capitalized in FY 2025. That was one of the reasons that also led to increase in expenses. We have the new injectable facility for GLP-1s, which will be commissioned in FY 2026. Now, when you really look at the market opportunity for GLP-1s, there are three large drugs, as you are all aware, Semaglutide, Tirzepatide, and Liraglutide. Liraglutide is the smallest in terms of the market revenues and the volume, but we have Semaglutide, which goes off-patent in the US and Europe starting 2031. Then you have Tirzepatide, which opens up after 2036. Of course, a large part of the volume over the next couple of years is going to be driven by Liraglutide and Semaglutide in emerging markets.
When you look at the capacities that we have created, of course, we have created capacities to address what we need over the next couple of years. As the market expands, which is the biggest thing that we are seeing, given that innovators have been focusing on supplying these drugs mainly in the advanced markets or U.S., Europe, there's still a large unaddressed market, especially in the emerging markets. We are, of course, keeping a track of the demand that we have in these markets, and we will look at expanding. Over the next two to three years, we don't need capacities for the demand that we expect in the near term. At some point in time, again, to reiterate that beyond 2031, when Semaglutide opens up in the U.S., Europe, and Terzapetide after 2035, we will need additional capacities.
At present, the Liraglutide is totally internally manufactured, or we are outsourcing some of the services? No, everything is internally manufactured as far as drug substance is concerned. We do have external CMOs as far as drug product is concerned. We, of course, also manufacture this in our own biologics facility.
Thank you so much. I will join you.
Thank you, Amir. We'll take the next question from Tushar Manudhane from Motilal Oswal.
Thanks for the opportunity. Just on insulin as part of our facilities, are we making any clearance pending for approval?
Tushar, I wasn't able to hear it clearly, but I think your question was, is there anything that is holding up the approval for Aspart in the U.S.? Is that the question?
Yes, sir. Yeah,
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 is our expectation. Of course, we have to wait for the decision of the agency, but we are quite hopeful.
If it is a goal date and approval happens on time, then subsequently, the formulary action and all so that we effectively—is this still an FI26 opportunity or FI27?
You are right that the decisions for any calendar year happen in that July to October time frame. Given that there is no real biosimilar option available at this point of time for payers, there is an interest in 26 as well. We will see how to launch this product in fiscal 26 in the U.S., and we will see how that commercial opportunity shapes up.
We'll keep you posted.
Sure, sir. Secondly, on CapEx, also, if you could share where are we in terms of queries responding to U.S. FDA?
We had indicated earlier there were no outstanding scientific queries. It was only pending inspection of the 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. We are hoping to receive an approval by then. There are no impediments in our mind.
This product is also manufactured entirely in-house?
Yeah, entirely. Drug substance as well as the formulation.
Got it. That's it, sir. Thank you.
Thanks, Tushar. We'll take the next question from Nitin Agarwal from DAM Capital. Please go ahead. Thanks for taking my question.
On the presentation, in the press release, we talked about launching five new biosimilars over the next 12 to 18 months. If you can just probably spell out which are these names that you have in mind for this calendar?
Certainly, Nitin, thanks for that question. The two 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 Amir's question. So that's the third one. We discussed the Aflibercept settlement in the launch. In July, we launched that in Canada. We have a clear launch date in the back half of 2026. 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. These are the five products we expect to launch in that 12-18 month window.
Thank you. Helpful. Where do you—and how do you see the pipeline of newer launches subsequently if you take a two to three-year block subsequent to F2027?
Nitin, in the past, we've said that, I mean, apart from the bunching up that has happened in the current time period because of whatever reasons, we've said that from 2025 to 2030, we saw ourselves launching a product a year, which is what we are seeing us—you're seeing us do now.
Okay. Secondly, on the insulin, you've touched upon that earlier.
The recent instances of some of the innovators, largely in Novo and Lilly, looking to go a little slow on some of their launches, some of their products in certain markets. I mean, this was an instance that definitely which happened in India. Are you seeing more of instances of them withdrawing certain SKUs across a range of emerging markets as well as developed markets in the insulin franchises?
Yeah. Again, 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. There are other geographies as well where we see it happening. 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.
Thank you for getting the last one. On Aflibercept, when we launch it next year, obviously, Amgen has already launched. Around that time, how do you see the competitive dynamics? It's going to be everyone else who's got approval comes in around the same time as you, or we get some sort of really limited competition around the time when we come in a second wave?
Yeah. I think the first piece is that we see this as a very large market. Probably 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.
I would not want to comment on anybody else at this stage. We certainly see ourselves in a very secure position there. From how we've been able to competitively settle the litigation or the way our settlement terms are, I think Nitin would appreciate that for competitive reasons. It's not fair for me to discuss. Thanks. Sorry, just a quick one. Last one, Saurabh. In the press release, we mentioned about a committee being appointed to evaluate a restructuring, including a possible merger of BL and BBL.
Any color on what the thought process behind that is and where are we in terms of exploring that option?
Let me respond to that by saying that 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. 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 board recommends—I mean, what the committee recommends to the board. At this point in time, that's all I can share with you.
Thank you, ma'am. Best of luck.
Thank you, Nitin. We'll take the next question from Lov Sharma from JP Morgan. Please go ahead.
Thanks, Saurabh. Just wanted to follow up on some of the debt metrics or debt numbers.
I think if you could just highlight, I think on the short-term debt, which I think has increased somewhere close to, let's say, on broader terms, about $630-$640 million. Could you just give a breakdown how much is working capital debited or how much is any other repayment which is coming due for FY2026?
Maybe if I can—Yeah, may I suggest that you take these questions offline because it will be easier for Kedar and Sudak to explain this to you in more detail?
Sure. That's okay. Yeah. Thank you. Thank you, ma'am.
Thank you, Love. Ladies and gentlemen, if you have a question, please check the raise hand option in the Zoom application.
That was the last question for the day. Kiran, any final remarks?
Thank you very much for all your questions.
If you have any further clarifications or queries, please do reach out to my colleagues, and they will be very happy to clear any of your queries. With that, I thank you for attending this analyst call, and I look forward to being with you again next quarter.
Thank you.
Thank you, Kiran. This concludes the call. Have a good day.
Thank you.