Good morning, everyone. Thank you for joining us today to discuss Biocon's fourth quarter and full year results for financial year 2026. A press release and the investor presentation relating to today's results have been filed with the exchanges and are also available on our website for your reference. As a reminder, in fiscal 2025 we had certain one-time benefits, including contributions from generic lenalidomide in the U.S. and divestment of our India branded formulations business. To enable a like-for-like comparison, we have provided adjusted financials excluding these items in our fact sheet and presentation. Let me now introduce the management team on today's call. We are joined by Biocon Chairperson, Dr. Kiran Mazumdar-Shaw, Mr. Shreehas Tambe, CEO and Managing Director of Biocon Limited, Mr. Kedar Upadhye, CFO of Biocon Limited, along with other senior members of our management team.
We will begin with opening remarks from Kiran, following which we will open the call for an interactive Q&A session. Please note that this call is being recorded. The recording will be made available on our website within a day, and the transcript will be shared shortly thereafter. Before we begin, I would also 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 relation to 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. Now I would like to hand over the call to Kiran for opening remarks. Over to you, Kiran.
Thank you, Prashant, and good morning, everyone. I would like to start by saying that Q4 marked a strong close to an important year for Biocon. We delivered a resilient performance, operating performance despite a very volatile macro environment, while also completing one of the most significant strategic transitions in our journey. The external environment remained challenging throughout the quarter, with geopolitical uncertainty continuing to impact supply chains, logistics, and energy costs. What stands out for me is the way our team stayed focused on execution and delivered a good performance, reinforcing the underlying resilience of our business. I want to particularly acknowledge our team for the way the integration of our biosimilars and generics business was concluded seamlessly in under 100 days with no disruption to business operations, customers, or patients.
It reflects the strength of our execution engine and the discipline with which we run this organization. This was a very complex organizational and financial undertaking, and it has been delivered with speed, discipline, and clarity of intent. With this, we are now operating as one unified biopharma entity with a stronger balance sheet, improved leverage metrics, and a more integrated global commercial footprint. As I've said before, this is a value-accretive step that creates a simpler, stronger, and more efficient operating model, unlocking synergies across our supply chain, commercial engine, and capital allocation. We are now moving from a phase of integration and investment to one focused on execution, operating leverage, and value creation. From a capital and investment perspective, the heavy lifting is largely done and behind us.
Over the past few years, we have invested materially to build global scale capabilities and capacity, particularly in biosimilars, insulins, peptides, and complex generics. As we stand today, this major investment phase is substantially complete. The emphasis now is on improving utilization, expanding margins, and driving steady improvement in return on capital employed. A key pillar of this transition has been the continued strengthening of our balance sheet. During the year, we made further progress on de-leveraging and improving financial flexibility. With the buyout of minority shareholders in Biocon Biologics and the repayment and refinancing actions already taken, we now have full economic ownership of our largest growth engine. Importantly, interest cost savings have begun to accrue, and the full annualized benefit will be visible from FY 2027, further supporting profitability and cash generation. Now, let me come to key business developments.
Now, before moving to the financial performance, let me highlight a few business developments that reinforce the strategic progress we are making across our portfolio. We achieved important product approvals in biosimilars and generics, further strengthening our presence in regulated markets. We received Health Canada approvals for Bosaya and Vevzuo, our denosumab biosimilars to Prolia and Xgeva, expanding our footprint in bone health and oncology, and adding momentum to this important franchise. After the close of the quarter, we announced the U.S. commercial launch of Bosaya and Aukelso, our denosumab biosimilars in the U.S. We also received U.S. FDA approvals for liraglutide during the quarter, covering both diabetes and weight management indications. Taken together, these developments reflect continued progress in advancing our portfolio across oncology, immunology, and metabolic diseases, while steadily translating approvals into commercial scale-up. Let me now walk you through the financial highlights.
In FY 2026, the group delivered a biosimilars-led 10% year-on-year growth in operating revenue, excluding the one-time bolus of generic lenalidomide in Q4 FY 2024, 2025. Biosimilars grew 12% year-on-year, and generics, excluding lenalidomide, was 13% growth year-on-year. CRDMO business grew 2% year-on-year. EBITDA was at INR 1,073 crores with a margin of 23%. Adjusted for generic lenalidomide in the base, this was up 29% year-on-year. The improvement was primarily driven by favorable revenue mix and operating leverage benefits in biosimilars. The reported net profit for the quarter before exceptionals was INR 179 crores. For FY 2026, adjusted for generic lenalidomide, operating revenues and EBITDA grew at 13% and 25% respectively. EBITDA margin stood at 22%, which is up around 200 basis points year-on-year on a like-to-like basis.
Reported net profit for FY 2026 before exceptionals stood at INR 436 crores. I would now like to discuss our business performance in a segmental manner. Let me start with biosimilars. The biosimilars business enters FY 2027 on a strong footing, with a broader portfolio expanding global footprint and improving profitability, positioning it well for the next phase of growth. In North America, Yesintek continued to gain traction in the U.S. market. This is our biosimilar ustekinumab. With growth supported by expanding formulary coverage and increasing physician confidence, the brand continues to build momentum in line with expectations, reinforcing our confidence in its longer-term potential. We also made progress with the launches of Bosaya and Aukelso, which is our biosimilar denosumab in the U.S.
Moving to Europe, during the quarter, we broadened our immunology footprint with the launch of Yesintek across multiple markets, expanded our ophthalmology presence with Yesafili, which is our biosimilar aflibercept in the U.K. and other key countries, and continue to expand our oncology franchise with Abevmy, which is our biosimilar bevacizumab, and Ogivri, biosimilar trastuzumab. We also launched Evfraxy, which is our biosimilar denosumab for bone health in Germany. On the regulatory front, [Swissmedic] approved our ustekinumab biosimilar Yesintek, and in the U.K. the MHRA granted approval for the Yesintek auto-injector, enhancing patient convenience and supporting broader uptake. Coming to emerging markets, execution during the period was driven by tender wins, new product filings, and selective launches across priority markets. We continue to scale the business through a mix of self-led operations in key countries and partnerships in others.
Coming to segment financials, biosimilars revenue for Q4 FY 2026 stood at INR 2,756 crores, representing a 12% year-on-year increase, driven primarily by advanced markets. EBITDA for the quarter stood at INR 720 crores, representing growth of 33% on a year-on-year basis. This translates into an EBITDA margin of 26%. Margins in this segment continue to reflect the benefits of improved revenue mix as well as operating leverage. R&D investments for the quarter stood at 7% of revenues, reaffirming our ongoing commitment to innovation and pipeline advancement. For FY 2026, biosimilar revenues and EBITDA grew at 16% and 40% respectively on a like-to-like basis. Now, coming to generics. We secured multiple approvals across key markets led by products in diabesity, oncology, and immunology.
This included liraglutide across the U.S. in the form of, which is generic Victoza and generic Saxenda, Europe generic Victoza, and Australia generic Saxenda. In addition, we received approval for everolimus tablets in the U.S. and for tacrolimus across Latin American markets. When it comes to segment financials for generics, revenue stood at INR 847 crores and adjusted for the one-time generic lenalidomide supplies in Q4 of FY 2025, revenues grew 13% year-on-year, driven by generic liraglutide sales in Europe. EBITDA stood at INR 75 crores. EBITDA margins were at 8%, improved nearly 300 basis points over Q3 of this fiscal, driven by higher volumes and operating leverage. For FY 2026, adjusted for generic lenalidomide, generic revenues and EBITDA grew 17% and 73% year-on-year respectively.
Now coming to our final part of our presentation, which is our CRDMO business. In Q4 FY 2026, revenues from operations were at INR 1,037 crore, up 2% year-on-year and up 13% quarter-on-quarter. FY 2026 revenue from operations were at INR 3,739 crore, up 3% year-on-year. Operating EBITDA margin at 25% for the year was in line with Syngene's revised full year guidance. Overall numbers reflected the specific impact from a single large molecule biologics client with the underlying business showing steady momentum. Syngene completed 14 client and regulatory audits during the quarter, bringing the full year total to 85. It also obtained the GCP/NABL accreditation during the quarter, reinforcing adherence to globally recognized standards for clinical research and data quality.
I now would like to wrap up with my concluding remarks. To conclude, FY 2026 marked a pivotal year for Biocon. With the integration complete, the major investment phase behind us, and the balance sheet significantly strengthened, we have entered the next phase of our journey. Our focus now is firmly on disciplined execution, driving growth, expanding margins, and delivering a sustained improvement in return on capital. As we look ahead to FY 2027, we expect to increasingly benefit from the foundations that have been laid with performance improving progressively as the year unfolds, especially as our new products scale up meaningfully in the second half. In biosimilars, recent launches across markets are beginning to scale, which should support continued growth and operating leverage. In generics, the emphasis will be on improving profitability as newer assets stabilize and utilization improves.
At Syngene, following the challenges seen in FY 2026, the focus remains on execution and translating recent investments in CRDMO capabilities into more stable performance. With a stronger foundation in place, we believe Biocon is well-positioned to deliver consistent performance and long-term value creation. With that, I now invite questions.
Thank you very much, ma'am. Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask questions may please click on the Raise Hand icon. Before asking the questions to the management, please introduce yourself, providing your name and your organization name. Please limit yourself to maximum of two questions so we can accommodate as many participants as possible. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from Neha Manpuria. Please introduce yourself and proceed with your question, ma'am.
Yeah, thanks for taking my question. This is Neha from Bank of America. Two questions from me. First, on the biosimilars revenue, given that we spoke about execution in the opening remarks, how should we think about FY 2027, FY 2028, given we have had some launches, you know, in the back end of 2026? There was an impact of the planned, you know, shutdown that we took in third quarter and a bunch of launches, but we haven't really seen material improvement in biosimilar revenue, you know, fourth quarter versus second quarter, if that is the comparable number, given we have also seen market share increases. Is it fair to assume that full stabilization of that disruption that we saw in the third quarter is not yet done?
Let me answer that. Kiran, can I go ahead? Let me respond to that, Neha, I think. Thank you for your question. I think this is important to look at. When we did the Q3 last quarter, we had indicated, like you rightly said, that we are, you know, slowing down some of these things to get ready for a greater supply for capability in the coming fiscal. I think if you look at the numbers between Q3 and Q4, you are seeing a sequential change where we moved from a quarter which was $279 million-$280 million to about $300+ million this quarter. There's a sequential growth of 12% that you're seeing on a group basis in the revenues. That's the first indication.
You're also seeing the margins stable for the full year basis, which has been consistent. That's, I think, the first indication that the business has ramped up in the right direction. The second question that you asked is that how is it from an outlook perspective for 2027, 2028? While we've not guided specifically on any numbers, I think the fact that we've got several products launching in the coming fiscal, which is 2027, 2028, the ramp up starts moving from the coming financial year in 2027, 2028 towards the later part of the year. That's why you set yourself up building capacity, increasing scale, and that is what you will see going through the year.
Last quarter, I also said that aspart will start seeing a ramp up, which will come in towards the second half of the concurrent fiscal year, we'll see that happen. We've publicly stated we have a negotiated settlement date with the originator for our aflibercept launch in the United States, you will see that play out in the coming fiscal year. We've seen tremendous success with our biosimilar ustekinumab, which continues to gain market share. In fact, if you've seen the IQVIA numbers as of February, in the overall market it's close to a fifth already, which is a very strong showing for a product which has several competitors there.
Recent news of payers have also shown that we've been able to secure good formulary placements. We are quite bullish about how our products are shaping up. You know, we've said that fiscal 2027, 2028, as we get towards the later part of the year, we'll start seeing the ramp up that we've prepared ourself for [audio distortion].
I understand you don't want to give specific guidance, if I were to think about fourth quarter FY 2027 exit run rate, you know, given the launches that we have, you know, what in your mind would be a comfortable number, you know, based on the launch pipeline?
Yes. I know that you've asked that question in different ways. I think the important thing, and I've, a gain, if you go back to what I've said in previous conversations as well, this is not a quarter-on-quarter conversation. Look at it on a broader window. If you've looked at the business that we've built over the last eight quarters or even four quarters, you will see a substantial shift. If you see just this year's numbers that we posted on a repeat basis, there's been a 16% growth over last year. We've just seen Yesintek, which is our biosimilar Stelara starting to show numbers in the P&L. You will start seeing that flow through in the second half of fiscal 2027 as more products come in.
I can only point you towards how we've done in the past, which is a strong showing already, and then tell you that look at the four quarters going forward, which will be a good way to see how the business ramps up.
Understood. Kedar, how should we think about de-leveraging in FY 2027, now that, you know, Biocon, the merger, Biocon Biologics merger is done? Is it fair to assume that all of the free cash flow generation that we have, you know, would be largely used for de-leveraging? Any color there?
That's true, Neha. I think every dollar that we generate out of free cash, the first claim is going to be to reduce the debt, and we are pretty serious about it. If you remember, in March 2025, including structured instruments, we had in fact more than $1.5 billion of net debt. That's down to $1.1 billion now. It will hover between $1.1 billion-$1.2 billion, subject to working capital. The free cash that we generate hereafter will go towards reduction of net debt, Neha. That's right. We also, Kiran referred interest cost reduction. If you remember, first quarter of this year we had booked, INR 280 crores in that quarter. It was trending upwards to INR 300 crore.
From those levels now we are down to about INR 210 crore-INR 220 crore. It will have some currency impact because large part of our debt is in U.S. dollars. In that sense, about INR 70 crores-INR 75 crores per quarter of interest cost reduction is being reflected in the P&L now.
Good. Thank you so much, Kedar.
Thank you. The next question is from Surya Patra. Please introduce yourself and proceed with your question. Mr. Surya Patra, I have unmuted your line. Please proceed, sir. As there is no response, we will move on to the next question, which is from Damayanti Kerai. Please introduce yourself and proceed with the question, ma'am.
Hello. Good morning, all. Thank you for the opportunity. My first question is again on biosimilars. First, if you can give a split for FY 2026 sales between developed market and rest of the world. If you can comment on two specific products, aflibercept, where you will be coming soon in the market as per your settlement date. There we have seen one of the earlier entrant going very aggressive in terms of taking market share, et cetera. How do you see that opportunity? Second question is on aspart, which you indicated is a key product for FY 2027. What kind of visibility we have in terms of higher demand or like your capability to supply this product to gain meaningful market share from here on? Thank you.
I think let me respond to the first one. Kedar can come in. In the past also we've said our distribution is pretty diversified between advanced markets, emerging markets. If I give you a split, it's been roughly NORAM at 40%, 35% with Europe and 25% emerging markets. You see sometimes a little bit of a shift between North America and Europe. You see sometimes North America slightly higher, but roughly 75/25 if you're asking advanced markets and emerging markets. Could be between 78/22 in a particular quarter, but that's the broad split, Damayanti. Kedar can give any specifics if there's anything. The other question that you asked in terms of our product launches, as I said, we are looking to bring our biosimilar aflibercept.
It's branded Yesafili to the United States in the second half of this year. I think what you've rightly cited is that there is a biosimilar today, and it's been quite successful. It's a very encouraging sign because this is a niche product, a specialty one, which is injected in the eyeball. One of the, one of the questions around it was will ophthalmologists be comfortable using a biosimilar? I think that myth's been busted that there is comfort in using that, and there is a willingness to use biosimilar. It's paved that path for us. Given our track record of high-quality products, we believe that there'll be a significant interest as we move forward. We feel good about our, I guess, Yesafili launch.
As the product ramps up in FY 2027, we'll be in a position to talk to you more about that. Your other question was related to biosimilar aspart, insulin aspart that we talked about. Our brand name there is Kirsty. Again, it's a product we've discussed several times with you. We see a tremendous opportunity. We've been very careful as it's a chronic product. We've said multiple times both for peptides and for insulin that we are very uniquely placed as the only company with a biosimilar insulin and a peptide portfolio. We've never looked at it as a sprint. It's a marathon for us. We have 100% share in certain closed-door networks that are there in the U.S. already, and we've built our credibility there.
We're looking to expand that to the commercial play in the second half of this fiscal year, FY 2027. Watch this space. We will keep you posted on how aspart ramps up in the current fiscal year.
Thanks, Shreehas. The second question I wanted to ask is on your capital allocation going ahead. As you mentioned, you are done with majority of investment in CapEx, et cetera, focus ahead will be on cash generation. Just wanted to have some more color on your focus in R&D. What kind of products you can add onto your portfolio, say, 2-3 years down the line? Apart from the Malaysia plant, do you have any other like CapEx remaining from your end?
At the beginning of the conversation, Kiran called out very clearly that we are in a space where capital allocation is largely behind us or capital investments are largely behind us. Given that we've now merged the biosimilar businesses and the generics business, it's strengthened our balance sheet right away. Immediately straight out the gate that's happened. Operating leverage starting to kick in, which you'll see flow through the first quarter that will come out. You will start seeing it. You heard Kedar talk about the fact that the use of proceeds has allowed us to bring in INR 300 crores of interest savings over the year, which would mean INR 75 odd crores per quarter. You are seeing a strengthening on the P&L.
Coming to the portfolio side, that allows you to do a lot of other things outside of this because you're no longer making investments in CapEx. You're trying to now see how you can get those assets to deliver maximum profitability for you. That's what we've done with the biosimilars business. If you've tracked us, which I know you have, for the last three years, where we're starting to see that play out as operating leverage. You will see that in our generics business as well because we have a very strong portfolio that we've built in the generics business as well, which is very complementary to our biosimilars business. That will kind of feed off the biosimilars capability we've built across several countries. That is what we expect to do.
We consolidate the business in the next four quarters and set it up for acceleration in the coming fiscal.
Shreehas, I'll get back in the queue. All the best.
Thank you, Damayanti.
Thank you. The next question is from Sanjay Kohli. Please introduce yourself and proceed, sir.
Yeah. This is Sanjay from Goldstone Capital. We are based, we are a private investment group based out of the NCR region. I have a specific question on the reported numbers in the income statement. Not been able to figure out under the head, this items that will be classified to, reclassified to P&L later. There's a large number of INR 760 for the quarter and then, which will be reclassified and which will not be reclassified. About, INR 210 crores. What exactly is this?
Sanjay, if you're referring to what is captured in the other comprehensive income, there are some adjustments that you do there which don't appear in the normal P&L. I'll take it offline. Why don't we take it offline, Sanjay?
How do I do that?
No, no. Let's get in touch after the call. Let's speak, and we'll explain. We have full backup.
Okay. Thank you.
Thank you.
Thank you. A reminder to all the participants that you may please click on the Raise Hand option to ask questions. We'll take the next question from Avnish Burman. Please introduce yourself and proceed with your question.
Yeah. Hi, good morning. This is Avnish Burman from Vaikarya. Shreehas, sir, just one question for you. In March, I think we saw some draft guidelines coming from the FDA which talked about significantly reducing the R&D cost to get, like, new biosimilars in the market. I just wanted your opinion on how that impacts, one, Biocon's existing products, commercialized products, and second, the pipeline. Thanks.
Thanks, Avnish, for your question. I think you've been tracking this well. We've been talking about this for a while, where we believe that the FDA which has led the way in saying that you do not need a phase III clinical trial to approve these high-quality biosimilars. That has significantly allowed us to do two things. One is it has reduced the development cost by 50%, so it's half the development cost. It's accelerated products from a development standpoint by at least 3-4 years, which is again cutting down time for products which can get into market. The common belief then is that it's lowered the bar to the market, which is incidentally not accurate.
Because what has happened is, while the clinical phase III trial requirement has been taken away, there has been an expectation of higher comparability standards, analytical comparability standards, that have been set up, so that, you know, you prove before you get to the clinical stage that your product is highly similar to the originator drug. The companies who've been developing this are clearly at an advantage. While it does look attractive to get into this market, and which is why you're seeing also lots of interest in this, which is again another thing we've said for a while, that biosimilars is the next growth area. You're seeing investments happen again with a lot of interest.
It does give companies like Biocon an advantage given our proven track record in CMC comparability and analytical characterization, which will be brought to bear as we go forward.
I understand it being beneficial for Biocon in terms of the products that you are still yet to bring in the market. What about the products where, you know, Biocon has a good position in the market, I mean, where you are the incumbent and you might be facing some incremental challenges in those products?
We do not see an incremental challenge because the products that we already have brought to market, if you were to look at the products that have been in the market, have got a very strong leadership position. If you look at the ones in the U.S., which we usually all collectively track on this call, our oncology portfolio, which is in the medical benefit space, have fourth of the U.S. market today. It, one is to get an approval, the other is to be able to reliably supply it, third is to do it consistently, and fourth is to be able to be a reliable partner to the physicians, to the healthcare givers, and be a reliable supplier to the patient who's looking forward to these products. That takes time. Credibility is built over a period of time.
I think we've been fortunate because it is something that we've worked hard towards. Being a fully integrated player, Avnish, has given a lot of levers to Biocon to operate and be successful in this space. We do not see a challenge, you know, because of these revised guidelines. In fact, it's a advantage Biocon, the way I see.
Thanks. Thanks a lot.
Thank you. The next question is from Siddharth Negandhi. Please introduce yourself and proceed.
Hi. Thanks for the opportunity. This is Siddharth Negandhi from CWC. Couple of questions. One, could you give us an understanding of the constant currency sales in each of the divisions? The second one was if you could give us some color in terms of market shares and the $200 million benchmark that you had shared last year. If you could give us an update on both of those, the market shares as well as the number of products that are above $200 million in biosimilars.
Yeah. Maybe I can take that. Siddharth, the growth numbers in rupees that we have reported, if you could roughly take about 3%-4% out, you'll get a dollar number. For example, biosimilars, we are seeing it's 12% growth year-on-year in this quarter. The dollar growth will be about 7% or so. That's the constant currency number. In terms of the products that were beyond INR 200 million, we have done good progress. insulin now has crossed INR 300 million actually this year, that's the bracket that it has crossed. That includes glargine, aspart, human insulin, DSDP. Total insulin franchise is now beyond INR 300 million. adalimumab is now beyond INR 250 million.
Pegfilgrastim, trastuzumab are hovering around INR 200 million or slightly lower than that. Bevacizumab has crossed INR 100 million now. This is without contribution from U.S. because the launch had just been made. There are products like etanercept, Yesintek is inching up now. That's how, Siddharth, the progress on the these four products that we had spoken last year.
Great. Kedar, if you could also help with any update on the market shares that you had shared last year. The margin improvement that we're seeing in the generics business adjusted for Revlimid, just wanted to understand, is that a function of the change in the API and formulation mix, or is there something else there?
Yeah. Your first question, Siddharth, was about the, you know, the biosimilars margin? Sorry, I missed that.
I think he wanted market share.
Market share.
Yeah.
Market share.
Yeah, sorry. Market shares are steady. I think the oncology market shares are steady around 23%-25%. Glargine market shares is also what's reported, about 11%, so that's fine. The next question was in terms of generics margins. We are guided for the fact that from the first quarter till fourth quarter sequentially, as the sales do inch up, there will be a margin improvement. I think quarter four you are seeing more than 10%, roughly 10% EBITDA margin, and that's because of both, you know, overall sales have gone up, so we have operating leverage benefit as the facilities get utilized, and there is a positive product mix as well.
Thanks. Thanks, Kedar.
Thank you.
Thank you. Participants, to ask questions, please click on the Raise Hand option available on your screen. The next question is from Tushar Manudhane. Please introduce yourself and proceed.
Thanks for the opportunity. This is Tushar from Motilal Oswal. Just on the biosimilars, what could be the capacity utilization currently?
Kedar, do you want to take that?
Yeah. I think, Tushar, it will obviously vary plant by plant, so there is no one number that we could give it to you now. I think capacities do remain healthy and, like what we mentioned last quarter in terms of upgrades and things like that, we are getting ready for the growth now. There's no one number that we can. Basically Malaysia and, you know, Bangalore, two. Within each location, like for example, Malaysia now we have two lines. In Bangalore there are multiple suites, as we have been speaking. There's no one number, but I think utilizations are healthy.
The direction which I'm trying to get through is that while we have a very robust portfolio and subsequent new approvals that might come through, but from a capacity standpoint, do we really need further capacity expansion or the current capacity would be good enough to drive growth for FY 2027/2028 in particular?
Yeah. As the Malaysia doubles, both for drug substance and drug product, I think we are fine there. Plus we have some external, you know, CMOs as well, as you know. In Bangalore, I think there could be minor debottlenecking here and there. As of now, we don't see any need for a large, greenfield CapEx, Tushar.
This Malaysia doubling, the timeline for this?
The DP has happened. The line two is getting qualified as we're speaking and will get operational soon. DS, the drug substance doubling will happen towards the end of this financial year.
Effectively, for full year 2027 compared to what we had in 2026, this DP, Malaysia in particular, is what will drive, and some amount of debottlenecking at Bangalore from a capacity standpoint is what will drive, growth for FY 2027. Is that a safe assumption?
Yes, after that as well. Correct.
Got it. Just to complete this point, like considering the earlier commentary in terms of product launches, largely second half FY 2027, so is it that the first half is going to be largely stable, maybe currency benefit is what will drive growth for biosimilars business?
Yeah, I mean, we don't guide specifically, Tushar. Like what Shreehas said, you should budget for incremental growth from new launches more towards second half. Yes, there'll be a currency advantage in the first half.
Just to add to what Kedar said, Tushar, just now you asked about the capacity and then the linkage to aspart. To that, Malaysia drug product line comes on stream this quarter. As you bring products, as I said, to the market, this line starts supplying product to the market, which is why the ramp up you will see happen through the year. As product moves up, you will see it, you know, ramp up towards the later half. That's the conversation we're having. The capacities are already invested in, and you will see the ramp up as it goes. It's not, it's not like there is no demand or capacity in the beginning. It just ramps up because the demand is set up and capacity comes on stream starting Q1.
Great, sir. Just lastly, to connect on this particular aspect, so will this require re-inspection or we are good to go in terms of commercials?
No, no, we are good to go on commercials. Yes.
Great. Great. That's on biosimilars. On the generic side, just to understand, will, you know, a good amount of investments largely behind both in terms of CapEx as well as product development. Now we are scaling up in terms of business without any a niche product, how to think about the scale-up of this business and subsequently the margin improvement, if you can just help us understand what is the gross margin currently and how the operating leverage will play out in the coming time?
I lost the question in between. Kedar, can you step in there? I can step in after that. Go ahead.
Yeah, yeah. I think, Tushar, the gross margins are in early 40s, and that's the 2/3 API, 1/3 generics. That's kind of a split today. As you know, you know, the GLP-1 revenues, which was about less than 10% of the overall, you know, business last year in FY 2026, that will scale up. Multiple launches that we alluded, that will scale up. I think, Shreehas, the question was what's the direction on generics growth and margins.
Tushar, I think, if you heard the opening remarks that Kiran started with, if you want to look at the base business itself, I think that is where you're starting to see growth on a sequential basis, which is the first good indicator that you are seeing.
Right.
Leaving aside the exceptional that we saw on lenalidomide. The focus for us going forward is very clearly going to be on margin improvement because we built state-of-the-art facilities. These facilities have now come on stream. As demand ramps up and capacity utilization is there, you will start seeing the margin improvements flow through. The focus is clearly going to be on making sure that that operating leverage kicks in in the coming quarters.
That would be supported by it's a scale-up of existing product or we will require new approvals to come through?
It is a mix of both. Many of these products, the approvals come in ahead of time, unlike the biosimilars business where product approval and launch are fairly close depending on the patent negotiations or the patent dance. The generics portfolio benefits from earlier visibility, and hence we are looking forward to launches in the coming years, which is why the capacity investment was done ahead of time, allowing us to do a lot more things, which we just referred to the peptide portfolio. Biocon would be set up in a very different way where you have fungibility for drug substance for the peptide portfolio as it gets into the fermentation space, which is, again, there are hardly any competition there. You have fungibility for the drug product facilities, which have also been set up.
As that demand ramps up in the coming quarters and coming years, you will start seeing better utilization and a better return on that investment that we made.
Got it, sir. Just lastly, BVZ, have I missed the sales for FY 2026? If you could just repeat.
It's INR 100 million, Tushar. It's entered in that bracket now.
Got it.
This is contribution from U.S. geography.
Got it, sir. Thanks a lot. That's it from me, sir.
Thank you. The next question is from Imtiaz Shefuddin. Please introduce yourself and proceed, sir. Mr. Shefuddin, please proceed with the question.
Can you hear me?
Yes.
Yes. Hi, this is Imtiaz Shefuddin from Barclays. A couple of questions from me with regards to your U.S. dollar bonds. Would you be able to provide some color on your hedging policy? I know you have benefits, I mean, currency benefits, but any specific hedging policy you have on the U.S. dollar bonds? That's my first question.
Imtiaz, on the bonds, we don't have to hedge because we have a natural hedge.
Okay.
We are largely a dollarized company, so we have significant dollar cash flows.
Okay.
We don't hedge our loan book actually.
Good stuff. Secondly, also on your U.S. dollar bonds, I mean, your bonds become callable from October this year, although at a premium price. How are you thinking on the bonds given that your U.S. dollar bonds are at 6.67% coupon, and you have talked about a focus on reducing your average cost of debt?
Yeah. Imtiaz, we are tracking the situation. We are happy that bonds are trading at a premium. You must have noted in the last few months, both the rating agencies have upgraded the rating. We are watching the situation. I think we have to evaluate whether it makes sense to pay the call premium in the first year. There is, as you know, this, you know, 50% call premium in the first year, 25% in the next year. That's the 5NC2 structure that we had. At this point of time, Imtiaz, we are watching the situation. We are happy with the way things have progressed and we are happy with the upgrades, and the idea will be to continue on this journey.
Great. Thank you.
Thanks. Thanks, Imtiaz.
Thank you. The next question is from Surya Patra. Please introduce yourself and proceed.
This is Surya from PhillipCapital. Thank you for this opportunity. Couple of questions. First with the ramp-up that we are likely to see in the biosimilar portfolio. Although we have started seeing strong growth in the U.S. business front, given the kind of products that has been launched during FY 2026. The products like Eylea that is there along with the denosumab contribution in the current financial year. What is the kind of a momentum that we would see for the U.S. business? What is the likely share of U.S. business in FY 2027 versus FY 2026?
Basically what we are seeing that, so far it is the non-U.S. would have supported the growth meaningfully, but now there is a strong lever for the U.S. to perform and really contribute meaningfully to the margins also. How the mix likely to see the shift?
Thanks. Thanks, Surya, for your question. I think this is very important. If you, two things that I will say. One is, in the past, you've heard me say that market share is not necessarily the only proxy for success. The other thing that I've said is that market share and ASP have always been inversely proportional in a medical benefit product. We've been very clear about making sure that we will grow business profitably. Growth is only when it's profitable. We've been very careful as we picked up market shares. The medical benefit products that you see today where we've, you know, had a 1/4 of the market, we've focused on making sure that we've retained that profitably.
We would be fine if that market share is not the proxy for where we are, but we will grow that slowly. The market has examples where you have tried to gain market share very quickly, but then you crash out also very fast because that's how the medical benefit space operates, because you have a declining average selling price, which is very contrary to how the pharmacy benefit space operates. We can have an offline discussion to walk you through the model. Last quarter when we had a conversation on how we are approaching denosumab, which is another important asset that we've launched in the U.S., it's branded. Kiran just talked about it in her opening remarks, that it's branded Bosaya and Aukelso.
We will be very careful in doing it because one of the brands is in the pharmacy benefit space and the other one is in medical benefit. Last quarter, as I was saying, our Chief Commercial Officer, Matt Erick, walked the team on the call about our strategy to commercialize them. Our focus is always profitable growth and not necessarily market shares. We will be very careful in doing that. I wouldn't necessarily look at market shares as the only proxy for success. Numbers will play out over the year, and you will see them being more enduring over a period of time. Yeah, I would advise you to look at that.
My guidance would be look at the broader quarter rather than trying to look at this as a quarter on quarter, immediate launch and an impact on market share kind of a business.
Sure, sir. sir, any clarity on the exclusivity that we could have for Eylea now?
For Eylea, when we've, our biosimilar position that we've got, as I said at the beginning, there is a biosimilar that is there in the market already. We've seen encouraging numbers from there, which tells us that we can actually commercialize that market very well, which is good news. The second part is, our terms for negotiation and settlement are confidential. Likewise, we wouldn't want to comment on others. We believe we will be in a good position when we get out of the gates for the launch in the U.S. As that plays out, Surya, you can see it come through. It wouldn't be fair on my part to comment on the terms of the settlement.
Okay. This insulin opportunity has been a kind of situation, market situation in the global market, given the GLP-1 play and all that. This is making us, or position us very strongly in the insulin side. The doubling capacity what we are talking of also, that is also complementing that story. Now this expanded capacity what we are talking, sir, what is the kind of lever that it is adding to the current insulin revenue of around INR 350 odd billion what Kedar just mentioned?
Again, we've been very clear right from the beginning that we are in that sense the only insulins company which has a peptides portfolio. That's something that we've heavily indexed on. We've built a very strong insulins franchise globally. There are several markets, I know we discussed the U.S. and certain European countries in this call, but there are several countries in emerging markets where our market shares are in excess of 50%. We are a very responsible supplier. We've continued to grow that franchise.
In dollar terms, we've refrained from giving numbers, but we see a very encouraging response in terms of how the product's grown, both for the long-acting and the short-acting insulin, or even the recombinant human insulin, which I'm constantly reminded is a very large, you know, requirement in several countries. We remain committed, Surya. We made these investments ahead of time, so you will see us, you know, get those products to market. It'll start playing out in the numbers, starting second half of this year is our view.
Last one question from my side, sir. Having seen the integration well, and also having done investment into the generics in advance, what should be the investment priorities for FY 2027 now for you?
The most like, I think, I think if you heard Kiran in the beginning, most of our investments are behind us, Surya. Our focus is always gonna be now that you have a strong balance sheet and you're looking to have operating leverage that's coming, the focus is gonna be capital allocation at this stage. We'll only focus on seeing how do you profitably, sustainably grow the business. We're not looking at a very big ticket, greenfield kind of expansion because we don't need it to support the business plan that's going forward. Focus is now on execution, consolidating the business and walking it through the quarters as we bring the business up in a sustainable manner. You will see the EBITDA growth that you've seen already in the margin profile improvement.
The focus will be to sustainably do that on a consistent basis.
Sure. That means CapEx is likely to subside.
Yes. We've already said that.
Yeah. Okay. Sure. Thank you, sir. Wish you all the best.
Thank you. We will take the next question from Vishal Manchanda. Please introduce yourself and proceed, sir.
Hi. Good morning. This is Vishal from Systematix. Can you break up your biosimilar sales between U.S., Europe, and the rest of world?
Yeah, Vishal. For the last two quarters, the mix of North America is slightly higher. In the past, we have said North America is about 40%, Europe and little of Japan, ANZ 35%, and emerging market 25%. Our hunch is, over the long term, that's how it will stay. Last two quarters, because of prioritization and higher growth, North America is higher, and that helps us obviously in the margins. Let's watch how this pans out. We obviously want all three geographies to grow equally.
Which would be your largest product as of now within the biosimilar portfolio?
Yeah. Within the biosimilars, NORAM, led by U.S., is about 46% this quarter. Last quarter it was slightly higher.
Kedar, I think his question was on products. I think you've given the product piece. Which products?
Yeah, yeah. Product-wise, globally, Vishal, we have already spoken, the insulin franchise, adalimumab. We don't break products into geography. That would be too much of a granularity.
Well, I mean globally. Like, globally, which is your largest biosimilar product?
Yeah, yeah. We just spoke about, Vishal. Total insulin franchise globally is gross $300 million. Adalimumab globally again is beyond $250 million. The other two key oncology assets are little less than $200 million. Bevacizumab is now $100+ million. There is Yesintek, there is etanercept. That's the mix.
Are we seeing annual price decline in the base portfolio and that or that is more or less flat and will, If you could share some color on the base business erosion or that remains flat?
I think each geography has its own pattern. Europe is usually very steady. North America, because of the strategy that we deployed on the ASP for the last three years, we have not seen much erosion. Yes, I think we should budget for some erosion, Vishal. Tough to tell you one specific number because it will vary depending upon the product life cycle.
Understood. Just one final one, what percentage of our biosimilar sales is manufactured in-house?
Yeah. I mean, the whole portfolio is in-house except adalimumab and etanercept. Yeah. We do take some help from CMOs in the human insulin, but we can come back to you with a specific number, Vishal.
Okay. Thank you very much. Thank you.
Thank you. The next question is from Nitin Agarwal. Please introduce yourself and proceed, sir. Mr. Agarwal, please proceed with your question.
Hello?
Yes, sir. Please proceed.
Yeah. Shreehas, on the insulin business, can you just give us a sense, you talked about you have now the short acting, long acting, as well as the recombinant insulin. What is the addressable market globally for across these three sort of insulins put together from a size perspective?
From a dollar number perspective, I think we can get you the numbers, but it will be around that $70 billion overall insulin. RHI is about $1.5 billion globally, and you'll see the other two be in the region of about $3 billion. The fact is that these numbers are not as reported by IQVIA. It changes significantly as you get towards emerging markets and tender businesses. Needless to say, it is a significant business with just the originators and limited number of players. In the U.S. you have just us, which has a biosimilar insulin, so that's a tremendous franchise to be focused on. There are other attractive assets that certain innovators are focused on, which interest them. That leaves a very large playing field for Biocon.
Sri, on that account, you know, there've been of late some recent approvals with Chinese companies which have come through. How should one think about that? In the past, Chinese have had a tendency to disrupt markets. Do you foresee some of those challenges for us in the broader insulin space?
I think the first indication of this is that it's, it signals the fact that what we've been saying, again, it validates it, that it's a extremely attractive market for people to come in, we've seen Southern European companies wanting to enter as well, partnering with other companies from China. This is clearly what we've been saying. It's a tremendous opportunity. The product remains in business, in requirement, several decades after it's commercialized. There are limited players and the product's going to be there forever. It kind of validates our thesis on insulin. Again, it also tells you that it takes a long time to develop it unless you're fully integrated and have the scale that we've built over decades. Being successful is not just having a product or an approval.
You need to be consistent. You need to be in a position to have a fermentation capability, the drug product capability, device capability, navigate the IP space. It's a long-term commitment which Biocon has done over the decades, and we are committed to this space.
Thank you so much.
Thank you. Ladies and gentlemen, that was the last question for today. I would now like to hand the conference back to Mr. Prashant Nair for closing comments. Thank you, and over to you, sir.
Yeah. Thanks, Michelle. Thank you everyone for joining the call. If you have any additional questions, please get in touch with the IR team and we'll be happy to address them. Thank you.
Thank you, members of the management. On behalf of Biocon Limited, that concludes this conference. Thank you for joining us, and you may exit the meeting now. Thank you.