Biocon Limited (NSE: BIOCON) Q3 2026 Earnings Call dated Feb. 13, 2026
Corporate Participants:
Prashant Nair — Head, Investor Relations
Kiran Mazumdar Shaw — Executive Chairperson
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
Siddharth Mittal — Chief Executive Officer and Managing Director
Kedar Upadhye — Chief Financial Officer
Analysts:
Neha Manpuria — Analyst
Surya Patra — Analyst
Shyam Srinivasan — Analyst
Abdulkader Puranwala — Analyst
Vishal Manchanda — Analyst
Tushar Manudhane — Analyst
Surjya Narayan Patro — Analyst
Sachin Jain — Analyst
Vipul Kumar Shah — Analyst
Presentation:
operator
Over to Mr. Prashant Nair from Biocon Investor Relations. Thank you. And over to you, Mr. Nair.
Prashant Nair — Head, Investor Relations
Thank you, Michelle. Good morning everyone. Thank you for joining us today to discuss Biocon’s third quarter results for financial year 26. A press release and presentation related to the same have been sent to the exchanges and are uploaded on our website for your reference. Before we get started, let me introduce the management team. On this call we have Biocon Chairperson, Dr. Kiran Mazumdar Shaw, Mr. Srihas Tambe, CEO and Managing Director, Biocon Biologics, Mr. Kedar Upadhya, CFO Biocon Biologics and along with other senior management colleagues across our business segments. We will start the call with opening remarks from Kiran which will be followed by an interactive Q and A session.
Please note that this webinar is being recorded. The recording will be made available on our website within a day and a call transcript will be made available subsequently. 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. And now I would like to hand over the call to Kiran for opening remarks.
Over to you Kiran.
Kiran Mazumdar Shaw — Executive Chairperson
Thank you Prashant. And I would also like to mention that Siddharth Mittal, CEO of biocon and his senior colleagues will also be on this call. Good morning everyone. The strategic transformation we set in motion with Biocon Biologics acquisition of Viatris Biosimilars business is now reaching its conclusion through the planned merger of Biocon Biologics with Biocon. This milestone transaction valued Biocon Biologics at 5.5 billion USD and will establish an integrated biopharma enterprise with global reach and scale, combining world class capabilities and biosimilars with our established strength in specialty generics. As we bring these businesses together, we are creating a platform positioned to accelerate growth, drive operational synergies and unlock significant long term value for all our stakeholders.
This resonates with the Finance Minister’s recent emphasis on strengthening the biologics and Biosimilars ecosystem in India through the Biopharma Shakti initiative. Biocon has been leading this agenda since the early 2000s, investing steadily in R and D talent and globally benchmarked manufacturing. These long term commitments have enabled us not only to become a global leader in biopharma from India, but also to drive India’s emergence as a credible global biopharma hub, delivering affordable, high quality, complex therapies at scale for non communicable diseases. Alongside this long term strategic agenda, we have taken decisive steps over the past year to strengthen biocon’s balance sheet and simplify its corporate structure.
These actions have transformed biocon into a fundamentally stronger, simpler and more investable global biopharma platform. Over the past year we proactively addressed acquisition related leverage through two successive QIPs, cumulatively raising nearly $1 billion. This enabled the full retirement of the structured debt associated with the Viatris transaction, materially de risking our capital structure, enhancing financial flexibility and removing a key overhang that had weighed on investor sentiment. The integration of Biocon Biologics into biocon is a strategic step that brings together our biosimilars and specialty genetics business into a single globally scaled platform. This creates a differentiated business model with greater diversification across therapy areas, geographies and product life cycles while also enabling unified governance, disciplined capital allocation and consolidated cash flows within one listed entity.
Importantly, biocon is uniquely positioned at the intersection of two of the fastest growing global metabolic segments, interchangeable biosimilar insulins and generic GLP1 peptides. Combined with our deepening biosimilars pipeline in oncology and immunology, this positions us well and truly at the forefront of affordable innovation in chronic and specialty care. Q3FY26 represents an important operational inflection point for Biocon. With major CAPEX now largely behind us and operating leverage beginning to play out, we are progressing from a phase of balance sheet resilience into a cycle of sustainable growth, margin expansion and a cash flow led value creation. With this strategic foundation in place, let me now share the key business and performance highlights for the group this quarter.
Portfolio and Pipeline Updates during this quarter we delivered significant milestones enhancing the depth and reach of our global biosimilars and generics portfolio. We recently disclosed three new biosimilar oncology assets Trastuzumab, Subq, Nivolimumab and Pembrolizumab. These are among the largest oncology biologics scheduled to lose exclusivity over the next five years. These are part of our existing portfolio of 17 oncology medications which includes Pertuzumab or Perjeta that was recently submitted to the US FDA as well as several small molecule cancer therapies. Our oncology portfolio, including undisclosed products represents almost $75 billion opportunity, or approximately 35% of the global oncology pharma market.
We launched Generic Liraglutide for diabetes and obesity in the Netherlands as our first direct to market GLP1 in the EU. We also signed an out licensing agreement with Ajanta Pharma to market our vertically integrated drug product semaglutide in 26 countries across Africa, Middle east and Central Asia. On 27 January, S&P Global Ratings upgraded Biocon Biologics long term issuer credit rating from BB to BB plus with a stable outlook. As S P noted, the stable outlook reflects its view that Biocon will sustain good earnings momentum over the next 12 to 18 months, enabling it to maintain its improved financial position.
More recently, Fitch Ratings also revised its outlook on biocon Biologics Long Term Foreign Currency Issuer Default Rating or IDR from stable to positive, citing expectations of a sustained reduction in biocon Limited’s financial leverage. These upgrades serve as strong external validation of the progress we have made in strengthening the balance sheet interest Balance sheet interest cost has already started coming down and as indicated earlier, we should see annualized savings of approximately 300 crores from FY27. Now let me walk you through the financial highlights in Q3. FY26 the group delivered 9% year on year growth in operating revenue, led by steady growth in biosimilars and generics that offset challenges in the CRDMO segment.
Operating revenue stood at 4,173 crores, up 9% year on year. Biosimilars grew 9% year on year. Generics had a strong showing at 24% year on year growth, whereas our seed RDMO business had a decline of 3% year on year. Core EBITDA was 12.21crores, up 21% year on year with a margin of 29%. This improvement was primarily driven by favorable revenue mix and operating leverage benefits in biosimilars. Our R and D investment was 249 crores or 8% of revenues excluding Syngene. Reflecting continued pipeline investments across generics and biosimilars. EBITDA grew 21% year on year to 951 crores with a margin of 22%.
Profit before tax excluding exceptionals rose 64% year on year to 226 crores. Reported net profit for the quarter was 144 crores. For the nine months of FY26, operating revenues and EBITDA grew at 14% and 24% respectively. On a like for like basis, core EBITDA margin stood at 27% versus 26% in the same period last year. Reported net profit for the nine months stood at 260 crores. I would now like to discuss our business performance in a segmental manner and let me start with Biosimilars. Our fully integrated global biosimilars business has been consistently delivering healthy growth backed by market share gains across regions and new launches.
Over the last nine months we have successfully launched Jesyntek, which is our biosimilar ustekinumab, Kirsty, our biosimilar Aspart Jobevni or our biosimilar Bevacizumab and Yesa Fili which is our biosimilar aflibercept across geographies and expect an imminent launch of Vevzuo and Bosaya which is our biosimilar denosumumab. As we look to scale up these products, we have taken some steps this quarter to upgrade our operational manufacturing and quality backbone in line with Best in class standards. While this moderated the pace of growth in Q3, it positions us very well for a more efficient and sustained ramp up ahead.
We also prioritize supplies towards higher margin markets which along with stable demand and pricing ensured higher profitability. As you will see in the financial details covered later, we expect to continue our growth trajectory and are well positioned for stronger growth in the next financial year. In terms of pipeline updates, we finalized patent settlements with Regeneron, Bayer and Amgen, clearing the way for the global launches of Yesa Phili, which is biosimilar Aflibercept and Vezuo and Bosaya which is our biosimilar denosumumab respectively. With these developments we have clear visibility on market entry and are well positioned to capture meaningful share in two large, fast growing therapeutic categories.
Another strategic move that enhances flexibility and cost efficiency is that we have secured full and exclusive global rights for Julio, which is our very successful biosimilar adelimumab from Fujifilm, Kyoma, Kirin Biologics Co. Ltd. Or FKB Japan. Biocon Biologics will assume end to end responsibility for manufacturing and commercialization along with rights for any additional development activities. Now coming to key highlights by geography starting with North America, the business delivered another strong performance in Q3. Our established oncology portfolio of Ogiveri and Fulfilla continue to hold nearly a fourth of the market in the U.S. yes, continue to gain meaningful traction in the biosimilar ustekinumab category, maintaining leading market share among biosimilars and over 70% market access commercial coverage.
We expanded our strategic collaboration with the Government of California through Civica Inc. During the quarter and this multi year transformational agreement enabled Civica to launch affordable insulin Glargine in California to expand access under the Cal RX initiative. Moving to Europe, we maintained stable market shares across products with the Oncology franchise led by Abevmi and Ogiveri delivering strong growth supported by robust tender and contracting performance. Yesyntec continues to receive strong reception in key EU markets. We also achieved two important regulatory milestones which were the MHRA approval for YESA Filip Prefilled Syringe and the EMA approval for Yasintech Auto Injector.
When it comes to emerging markets, our business delivered a stable performance supported by steady demand in high impact self led markets. We successfully launched Yesa Fili in Turkey achieving almost 20% market share. We secured key tender wins across APAC, Middle East, North Africa and Latin America for insulins and MABS. Moving to the financials biosimilar revenues for Q3 stood at 2,497 crores representing a 9% year on year increase driven primarily by North America market. EBITDA for the quarter stood at 700 crores representing growth of 44% on a year on year basis. This translates into an EBITDA margin of 28%.
Margin improvement in this quarter reflects better product and geography mix as well as operating leverage benefits as we continue to realize the benefits of economies of scale. R and D investments for the quarter stood at 7% of revenues reaffirming our ongoing commitment to innovation and pipeline advancement and for the third consecutive quarter profit before tax exceeded 100 crores for the nine months FY26 biosimilars revenue and EBITDA grew at 17% and 42% respectively on a like for like basis. Now coming to Generics the generics business continued to see momentum in the third quarter delivering a year on year revenue growth of 24%.
This performance was supported by an ongoing launches of generic Liraglutide across EU markets and an improved performance in the generic formulations based business. In terms of R D and operational updates, we achieved strong regulatory progress with multiple market filings including 10 generic formulations and nine API DMFs across US, EU, UK and key rest of the world markets. In the US we received final approval for Tofacitinib extended release tablets and Everolimus tablets for oral suspension. On the operations front, we successfully completed the first commercial dispatch produced under the Phase 2 expansion at Cranberry, New Jersey. In terms of regulatory updates, we received an EIR with VAI status from the US FDA for a OSD facility in Cranberry USA following an audit conducted in October 2025.
The API plant in Visakhapatnam also received an EIR from US FDA with a VAI status following a GMP inspection conducted in November 2025. Our API plant in Bangalore received a GMP certification from N Visa Brazil post an audit conducted in July 2025. Now coming to segmental financials revenue of the generics division recorded 851 crores which is a 24% year on year increase. Sequentially revenues grew 10%. R&D investment stood at 76 crores or 9% of segment revenue. With continued progress across our GLP1 and injectables portfolio, EBITDA stood at 47 crores, an improvement over last year and the previous quarter driven largely by higher revenues.
For the nine months, FY26 generics revenue grew at 18% year on year while EBITDA declined by 32% attributable to higher costs related to the new facilities we have commissioned in the recent past. Now coming to The CRDMO Business FY26 nine months revenue from operations stood at 2,702 crores up 3% year on year. Third quarter revenues from operations were at 917 crores down 3% year on year. As has already been disclosed, the business has been impacted by challenges faced due to one customer. While this pressure will take some time to fully ease, it is transient. Syngene’s differentiated scientific capabilities, long standing client relationships and diversified model across research, services and CDMO continue to underpin the business and give us strong confidence in its medium to long term growth trajectory.
During the year, Syngene extended its long standing partnership with Bristol Myers Squibb or BMS which runs through 2035, broadening the scope of its integrated services across discovery, translational sciences, pharmaceutical development, manufacturing and clinical trials. The company commissioned a commercial scale facility for liquid filled hard gelatin capsules, strengthening its oral solid dosage platform and enabling precise, reliable manufacturing of complex medicines. Syngene also expanded its advanced chemistry capabilities at Hyderabad with catalytic screening and flow chemistry labs enabling faster, safer and scalable synthesis of high quality drug substances. With a renewed focus on diversifying its customer base in cdmo, Syngene expects to increase capacity utilization of its manufacturing facilities both in India and the us.
Now to wrap up, I would like to emphasize the progress we have made on multiple fronts including our product basket and pipeline, go to market execution and building a strong long term operating model. Today we are well positioned globally across High growth segments of diabetes, oncology and immunology supported by a differentiated portfolio spanning biosimilars, insulins, generics, peptides including GLP1s. As we look ahead, our focus remains clear. Driving steady sustainable growth, expanding margins and consistently improving return on capital employed. We are confident in our ability to drive and deliver long term value for our stakeholders through the Biocon 1 strategy.
With that, I now invite your questions.
operator
Thank you very much ma’. Am. We will now begin the question and answer session. Anyone who wishes to ask questions may 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.
Neha Manpuria — Analyst
Hi, this is Neha from BofA securities. First question on the biosimilar business. The upgrade of production and quality that you mentioned. Is it fair to assume that this is largely done and behind us? And second, what led to this, you know, need for this updation of production? Because you know, these approvals were expected, you know, to come through this year. So. So any specific reason that drove this upgradation at this point of time?
Kiran Mazumdar Shaw — Executive Chairperson
So maybe I will ask Shreyas to answer that question.
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
Thank you Kiran. Thank you Neha for the question. I think that question is fair. And as you’ve seen us talk to over the last few quarters, you would have seen us receive several approvals of new products across geographies. We are also launching several products. You heard Kiran in her opening remarks talk about several launches that are upcoming. We are also seeing a very substantial demand for our products across the US and in Europe. So what we’ve done in the current quarter, which was a planned operation where we upgraded our facilities to be able to scale up and be able to deliver on this increased demand as we go along.
So in the coming quarter of course it continues in our growth trajectory like we had projected. And as we focused on this current quarter which you saw in our financials, we were able to also, given that we had a good demand for our products, prioritize high margin markets which preserved the margins. In fact, you will see that those margins have been higher than what our guidance has been in the mid-20s. So we believe that this is gone as, as we had projected and on a full year basis we’ll of course be in the mid-20s on our margins as well.
Neha Manpuria — Analyst
Shasta, how should we think about growth from here? Like you said that you know, for the full year we’re still guiding mid-20s next year. Given we have a bunch of these launches that will flow through, should we get back to the 20 plus percent growth trajectory for the biosimilar business with the mid-20s margin or should that margin also improve going into next year?
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
Yeah, I mean as I have said we’ve refrained from giving specific guidance for the future. We did say that we will have the mid-20s for the current financial year. I think if you look back at what growth has been, it’s been strong growth in the last several quarters that we’ve had and with the launches now set up, which we’ve just talked about with demand growing across geographies it is, it’s obvious that some of these things are expected to improve. But I’ll refrain from giving any specifics on how the margins are expected to improve. But clearly the future is more exciting than what the past has been is a fair way to look at it.
Neha Manpuria — Analyst
Understood. And sorry if I make squeeze in one one more question. I think we mentioned about CapEx being largely behind and a lot of the focus now on cash flow generation. You know, could you help us through what the CAPEX would look like for the consolidated entity in you know, fiscal 20, 26 and 27 and should we expect that to moderate as we look at the next two, three years?
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
I think maybe Kedar can come in on this one at Biocon Biologics neha as you know most of our investments were behind us. The only real investment that we were focused on was our insulin capacity that we were looking to double. The drug product capacity comes online in the coming fiscal year so we expect to double our capacity. That investment is clearly behind us and capacity will will significantly increase in the coming fiscal. The only other thing which was going on was our insulin drug substance. So there is nothing new that that we are investing on Capex.
But maybe Kedar, if you want to add some, some more color on this.
Neha Manpuria — Analyst
No, that’s right Shreyas. At a group level we were tracking roughly 275 million dollar plus NEHA if you recollect of CAPEX every year that has been moderated to less than 225 and going forward as the Malaysian capacity buildup gets over I think we will see further moderation because largely hereafter it will be maintenance CAPEX across three companies.
Kiran Mazumdar Shaw — Executive Chairperson
I think Siddharth, if you want to mention also that our investments in the peptides Also is largely behind us.
Siddharth Mittal — Chief Executive Officer and Managing Director
So I think we have invested of course in many facilities including Peptides, expanding our drug substance facility. And last year we commissioned our drug product facility. So large part of Capex in generics is over. Now it will be mainly the maintenance Capex which will be there which is going to be very small compared to the previous investments.
Neha Manpuria — Analyst
Understood. Thank you so much.
operator
Thank you. The next question is from Damyanti Kai. Please introduce yourself and proceed with the question. Ma’.Am.
Siddharth Mittal — Chief Executive Officer and Managing Director
Hi, good morning all. Thank you for the opportunity. This is Damyanthi from HSVC securities. So my first question is just want to understand your other operating expense during the quarter. So last time when we were discussing we understood most of your costs are in base but sequencing here also we saw 10% jump. If you can help understand that. And how should we look at operating expense trajectory in coming quarters?
Kiran Mazumdar Shaw — Executive Chairperson
Kedar, would you like to take that?
Kedar Upadhye — Chief Financial Officer
Yeah, yeah. So Damayanti, I think if you are referring to this other expense row which is about 1178 crores that comprises the expenditure across manufacturing facilities, quality expenses, commercial expenses across three entities and that is largely fixed in nature. There is some element which is linked to the sales across all the three companies. And the growth of that particular line will be lower than the revenue growth. That’s how I think it’s going to trend here after the MIC because most of the base spends on commercial setup, regulatory setup, all the global infrastructure for manufacturing, quality enabling functions, all that is already in.
Siddharth Mittal — Chief Executive Officer and Managing Director
Okay, so the current quarter number is new base if, if we have to look at. And it will be mostly linked to the a top line movement, the variable part.
Kedar Upadhye — Chief Financial Officer
That’s true.
Siddharth Mittal — Chief Executive Officer and Managing Director
Okay so Kedar, can you also update us on the net net debt position as of December 31st or as of say current?
Kedar Upadhye — Chief Financial Officer
Yeah, so the net debt that we owe to the bondholders and the banks it’s in a very shift in a narrow range of 1.1 to 1.2 billion. You know we have said that all the structured debt, you know have been retired. So end of June the Goldman instrument got retired. 1st October Kotak instrument got retired. And first week of January we have retired Edelweiss as well. So all that is over this quarter. You’ve seen a decrease in the finance costs by more than 62 crore sequentially. And if you could, if you could recollect before we started this exercise, you know the annualized run rate of interest cost was trending upwards of 1150 to 1200 crores.
And that we have been able to substantially bring it down the main thing.
operator
Okay, sure. My last question is what is your rational to acquire the full global rights for Julio Adalimumab given it? It was a challenge, challenging market in the U.S. right. And then that was a key market. We were looking forward. But if you can just discuss that. As well, you might want to take that.
Neha Manpuria — Analyst
Yeah. Thanks Kiran. Thank you for the question. See, Fulio for us is contrary to the perception how you qualified. It has been a very, very successful franchise. We’ve consistently for the last five and this is probably the sixth year that we’ve grown that franchise in Europe. It continues to be one of our products that delivers in excess of $200 million for us on an annual basis. So at Elemu Mab, Julio is a very successful franchise for us in the portfolio. And given that that was a product that we’ve continued to invest in, we’ve wanted to always be a fully integrated player.
So this was a product we developed very closely with our partners in Japan. It’s been very successful. And as we take it forward and increase our portfolio in the Onco Immuno space, it made a lot of sense for us to to integrate that product as well. So which is why that’s the rationale and the thinking behind bringing Julio into the fold as a fully integrated play.
Kedar Upadhye — Chief Financial Officer
So Shreyas, will that also improve our expectation for the US market or it will be mostly for ex US market which. Which will be meaningful.
Neha Manpuria — Analyst
It would be meaningful for global markets. The Mendi will also give us the opportunity to also widen our offerings. As you know, we’ve had currently a product which has only the low concentration product in the market. We will also have the opportunity to develop beyond that. And those are things we’ve talked about in the past as well with the community. And clearly now Biocon has the ability to determine its future and the destiny with this product.
operator
Okay, thank you. Thank you everyone. Thank you. A reminder to all the participants that you may please click on the raise hand option to ask questions at this time. The next question is from Surya Patra. Please introduce yourself and proceed with your question.
Kedar Upadhye — Chief Financial Officer
Yeah, thank you. Thanks for this opportunity. So first clarification to the earlier commentary that you have made. Adeline is a. Julio is a 200 plus million dollar business for us. Is that correct? And a couple of quarterback that you had mentioned, you have three molecule which have crossed $200 million. So whether this is one of that.
Kiran Mazumdar Shaw — Executive Chairperson
Yes, yes. In fact we had four molecules. Surya who are in the zone of 200 million annualized as of last year. And yes, Adalimumab is one of those.
Kedar Upadhye — Chief Financial Officer
I believe you are mute. Yeah. Can you hear me? Surya? What I was saying is that yes, we had 4 molecules in the zone of 200 million annualized revenues and Adalimumab was one of that.
operator
Sorry Kedar, I cannot hear you.
Kiran Mazumdar Shaw — Executive Chairperson
No, let me, let me. If you can’t hear Kedar, let me say that. Kedar was saying that it’s not three but four molecules which are $200 million plus and adalimumab is one of them. Can you hear?
Surya Patra — Analyst
Yes ma’. Am. Mr. Patra, I would request you to kindly check your network and your setup. I think there is a network issue or maybe the audio issue at your end. I would request you to kindly rejoin the meeting. In the meanwhile we’ll take the next participant. Shyam Srinivasan. Please introduce yourself and proceed to the question.
Shyam Srinivasan — Analyst
Sir, hi, good morning, this is Shyam Srinivasan from Goldman Sachs research. Just first question is just on the trajectory of the biologics business. Maybe I’m not looking at quarterly variations but yes, there’s been a slight slowdown in growth I think Shreyas, you alluded to higher growth going forward. So what are some of the drivers of that? That gives us confidence. I know I’m not asking for a quantitative number but just what drives revenue. So nine month is also 17% and I’m assuming very difficult to see what the underlying constant currency growth is. Right. There has been a rupee depreciation impact as well.
So just want to see when are we moving to a slightly faster trajectory of revenue growth in the biologics business.
Neha Manpuria — Analyst
Thanks Shyam for your question. I think. Let me respond to you in a. In a couple of points that you made and let’s look at what data points we will refer to. I think the first step being that if you look back almost seven or eight quarters I think there’s been year on year growth that we can look at and we’ll also look at sequential growth that we’ve had quarter on quarter. Now we know that the last full year we didn’t have any new launches and yet we saw that there was significant increase in revenues year on year as well.
So we can go through the numbers, we can look up that data for you. But I think characterizing it as slowing down of growth is probably something we’ll have to sit down and look at. Now coming to where it is headed when I was responding to a question which Neha had asked earlier. We’ve clearly bought five new products, some of them we’ve launched. You’ve seen the uptick of yes intech in the US seeing a tremendous response. We’ve seen over 70% formulary coverage. We’ve been amongst those few biosimilars in the US which has now got double digit market shares.
So clearly there’s a step up from where it was and growth will obviously be expected when you have new product launches which would have then also higher knock on effect on the margins that we were talking about earlier. We’ve refrained from giving specifics because there would also be some erosion in the legacy products which have been in there in the market. So we’ll have to wait and watch. But we clearly feel very good about how things are trending.
Shyam Srinivasan — Analyst
Helpful, helpful shares. Just a second question on the generics business. I think very solid performance this quarter. If you could kind of break it down into just the new what is traction on the new launches including the GLP1s and how should we look at say again outlook for this business.
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
So Shyam, I think as Kiran mentioned in our opening comments the growth was driven primarily by liraglutide launch in European markets which was through our partners Antiva as well as direct to market in couple of countries and I think that traction would continue. We will be launching this product in few more European countries in fourth quarter. We will also be supplying more product to our partner and apart from Europe we are of course looking at other markets. So you know our filing is under advanced stages of review in various markets including the US and depending on of course the FD action.
We are hopeful that we should be able to launch the product in US and other Latin American markets in the coming quarters. The the demand is still very solid. Of course it’s a degrowing market because a lot of patients over the last couple of years have moved to Ozempic. But we still see that there is a lot of demand, there is limited competition and we have a very good play that we will that which will drive the growth. Now apart from Liraglutide we had a couple of other products also that were launched. These are OSDs and we have couple of more launches coming up and the base business also is doing good.
The market share of our products is holding up in the US I think overall things are looking good, primarily contributed by Lira but other products also will continue to drive the growth.
operator
Helpful Siddharth, just one sub question on the GLP1 and semaglutide in Canada. Elsewhere if you could give us an Update. Thank you. All the best.
Kedar Upadhye — Chief Financial Officer
So we’ve we had mentioned in quarter two that the filings have begun. We have filed in Canada, Brazil, Saudi, Turkey and we continue to file in other markets. Of course it’s the review cycle is long drawn, especially in markets such as Canada where we have not seen a single generic GLP being approved, including liraglutide which has not been approved by Health Canada. So we are hoping that sometime next calendar year we should be in a position where we at least make advance progress on semaglutide. And I think the market still is very attractive. We have seen the actions taken by Health Canada on some of the earlier filers and it continues to be bit complex but we are hopeful that next year we should be able to make a good progress with Health Canada.
Vishal Manchanda — Analyst
Got it. Thank you. All the best.
Kedar Upadhye — Chief Financial Officer
Thank you.
operator
Thank you. The next question is from Tushar Manudane. Please introduce yourself and proceed with the question.
Tushar Manudhane — Analyst
Myself from Motula Financial Services. So firstly just extending Sham’s question on Canada policy. If you could, you know, share your perspective in terms of what’s holding on Canada as a regulatory authority for approving the GNP biosimilars or generics. That, that’s my first question.
Kedar Upadhye — Chief Financial Officer
The biosimilar of course, I mean shares can comment on it. We have seen many approvals of biosimilars in Canada. I think the GLP1 of course has a separate guideline path that Health Canada follows and it is bit different compared to what a European regulator or US FDA follows. And I think as I mentioned that despite filings, multiple filings on lira glutide and other GLPs, Health Canada has not approved a single file. They are I think still trying to understand the risk associated with this product and the develop the, the pre clinical work that the generic filers have to do.
And I think we have done back and forth with Health Canada on our previous filing of Lira glutide. So we do understand a bit of what they are expecting and I think we are hopeful that, you know, over a period of this year they should be able to, you know, be very fixed and firm in terms of what they’re looking at. And that’s why we have a confidence that by next year that we should be able to get the approval. I think we have mentioned in the past, we know we are a vertically integrated player on glps.
So we have very strong characterization and development capabilities. We have our own drug product facility, we have our own device facility. So we understand the science behind it. And I think we have to work with the regulator to explain that why it’s a high quality product, why it’s a comparable product and you know, as I said, navigate the challenges. And it’s not the generic filers. I mean we have seen other very credible companies who’ve also filed and have had challenges. And I think it’s the working with the regulators what’s required and I think they also understand that they have to approve it.
If you look at Canadian market, which is $25 billion today, OIC and WeGovi is give or take, 8 to 10% of that market. So bringing down the cost and making the drug affordable is of course a priority for the regulator as well. And I’m sure that, you know, we will, along with other filers, navigate that challenge soon.
Tushar Manudhane — Analyst
So here is this because innovators manufacturing through biological routes where filers we have done it through synthesis route. Is that something no area of concern?
Kedar Upadhye — Chief Financial Officer
No, I think that is very clear globally that everywhere, including U.S. and Europe, everybody is developing with the synthetic route. So that is not a concern.
Kedar Upadhye — Chief Financial Officer
So I think if I may just jump in too short, Liraglutide has been approved by Europe. So if you look at that as a case in point, then, you know, I don’t think, you know, that is the issue. I think Health Canada really has to have a regulatory final view on what it requires to approve. And I think that is not very clear on all GLP1s. So I think that is where the real issue is. But I think it should be resolved soon is our expectation.
Tushar Manudhane — Analyst
Got it. And just on the progress on the insulin as part, you could share.
Kedar Upadhye — Chief Financial Officer
So insulin as part has been approved Both in the U.S. as you know, as the first interchangeable insulin. Aspart. It is already approved in Europe and maybe I’ll ask Shreyas to comment on what is it that you exactly want to know?
operator
How the commercial scale up is, you know, expected to happen over next 12 months.
Kedar Upadhye — Chief Financial Officer
Thanks, thanks. Thanks Dushan for the question. And, and we can add more color to, to what we were just saying when Kiran commented on it. We’re very proud of the fact that we are the first interchangeable rapid acting analog that the FDA has approved. We’ve got approval prior in other jurisdictions as well. We’ve said in the past that we are a very responsible insulin company where clearly there’s tremendous opportunity here again, like some other products, we see that there’s just the originator in us that are looking to target this. We’ve had a very Very successful entry into the US market with the closed door hospital networks.
That chain has already been very successful. We see close to 100% conversion to our product. So that’s been very good response that we’ve seen. And now as Matt who is our chief Commercial officer for Advanced Market and Josh Salsi who leads the North America team deal with the responses coming up, you will see more progress into a wider group of customers as we expand our presence in the North America market with this asset.
Tushar Manudhane — Analyst
So effectively let convert into let’s say the business in let’s say starting off this calendar year or this process will sort of have its own gestation period and accordingly the business scale up will be somewhere maybe like three to five months down the line. How to think about it, we would.
Kedar Upadhye — Chief Financial Officer
Certainly look to move this product into this financial year. As you know our demand for insulin Tushar has been growing and we are looking to add more capacity. I just talked about doubling our drug product capacity this fiscal. Our insulin glygen capacity demand continues to expand. So we are looking to now bring more product in so that we can be a reliable supplier and a partner to our customers and patients as we bring more products in the insulin franchise. So this should happen in the current fiscal and we look to expand that to more customers beyond what we’ve done so far.
operator
All right, so that’s helpful. Thanks. Thanks a lot. Thanks.
operator
Man who wishes to ask questions may please click on the raise hand icon available on their screens. We’ll take the next question from Surya Patra. Please introduce yourself and proceed with the question. Sir.
Surjya Narayan Patro — Analyst
Yeah. Thanks for the opportunity. This is Surya from Philanthropy. My sorry for the repetition of the question. Question I could not hear last time so I was asking that whether business for us and is it one of the top three products which have crossed 200 million for us?
Kiran Mazumdar Shaw — Executive Chairperson
So let me answer that by saying that Keda said it’s not three but four molecules which have got over $200 million in revenue and Adalimumab is one of them. Can you hear? I think you’ll have to take this off the line offline because he cannot hear for some reason.
Surjya Narayan Patro — Analyst
Yes ma’. Am. We’ll move on to the next question from Harshad Dutch. Please introduce yourself and proceed with the question.
Siddharth Mittal — Chief Executive Officer and Managing Director
Thanks a lot for the opportunity Ma’. Am. Harshit Duti from Diamond Asia Capital. Just one bookkeeping question. A rabid of 700 crores in biosimilars business. Is there any inclusion of the exceptional gain which you have put in a notes to accounts in this 700 crores number.
Kedar Upadhye — Chief Financial Officer
No Harshit, that gain is in the exceptional line. It’s not part of the ordinary business. So that gain that we have realized by virtue of the integration transaction is not in the EBITDA line.
Surya Patra — Analyst
So 700 crore is the clean EBITDA Kedar. Yes, for biosimilars. So can you please elaborate? What, what have, what has changed? Because sequentially top line was down and EBITDA shoot up. So what were the improvements that drove this? The good number in biosimilars business.
Kedar Upadhye — Chief Financial Officer
Yeah. So Shreya has clarified that this quarter we have prioritized high margin markets. So usually the North American geography mix out of total biosimilars is roughly 40. This quarter is, you know, it’s beyond 46, 47. And that’s the reason we have been able to get both higher gross margin and EBITDA as a percentage terms. For, for your simulation and modeling you should consider let’s say full year average because you know the other regions will shape up in the coming quarters. So maybe you should go around with, with our usual margin and a full year average margin and not this quarter’s margin.
Surya Patra — Analyst
Okay, thanks. Thanks a lot.
operator
Thank you. The next question is from Sachin Jain. Please introduce yourself and proceed with your question.
Sachin Jain — Analyst
Am I audible?
operator
Yeah, your audio is low. If you could be a little bit louder.
Sachin Jain — Analyst
Want your view on the insulin market. Is it now is a supply constrained market particularly when innovator moved their capacity towards weight loss drug. So how is the current scenario? Can you just give some overview on that? Shreyas, you might want to answer.
Kedar Upadhye — Chief Financial Officer
Well I, I only could hear you Sachin briefly you said is it a supply constrained or a demand constraint market? Did you refer any specific product or product?
Sachin Jain — Analyst
No, he said he, the question he asked was is given that GLP1S is where the innovators have been focusing on is insulin a supply constraint market or what is happening? He wants to know.
Kedar Upadhye — Chief Financial Officer
Well I think the way I would classify this is that the insulin demand has continued to be robust such in and given that there is just the innovators and biocon it is a very unique situation to be in. We’ve made significant investments in our unique technology platform. So we have a proprietary platform on which we make our insulins which is innovative in that sense and we also have very large scale manufacturing capacities, device capabilities which is needed for insulin. So demand is absolutely not a challenge here at all and it is as much as we can make.
Which is why when I was responding to Tushar we’ve been very responsible in taking on more patients because this is something, when you take on a chronic therapy, you do it for life. And we are doubling our capacity in the drug product, insulin capacity and you will see that franchise grow in the coming quarters as we, as we take on more market share. We do not, we do not expect that the insulin demand globally will, will, will reduce and we expect us to be a very, very significant player in the insulin space.
Sachin Jain — Analyst
When you believe, likely believe Malaysia expansion will come, will commercialize.
Kedar Upadhye — Chief Financial Officer
Sorry if you, I’m sorry, very feeble. But my understanding of your question is when do you see the Malaysia expansion go commercial? If that is your question then then the drug product is expected to go commercial in the, in the coming fiscal which is fiscal 27 and the drug substance expansion which is also expected to double our capacity will come in a year or year and a half after this.
Sachin Jain — Analyst
Thank you. Thank you so much.
operator
Thank you. The next question is from Siddharth Negandi. Please introduce yourself and proceed with your question.
Siddharth Mittal — Chief Executive Officer and Managing Director
This is Siddharth Negandi from Chanakya. Thanks. Thanks for the opportunity. Just a couple of nuances on the biosimilars business. Given we launched new products in this quarter and the previous quarter, could you give us a sense of how the year on year and quarter on quarter growth plays out between the existing products and you know, the new launches? That was question, that was the first part of the question. And similarly would it be fair to assume given the higher salience in the US that we’ve seen a year on year or quarter on quarter decline in eu? So that was one.
The second was if you could share some color on the market share of the products, both the legacy products and some of the new products and insurance.
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
I think multiple questions in that. The first one is how do you look at the quarter wise progress of these numbers. My sense is, I think Kedar responded previously is the way to look at this is a wider window of four quarters and as new products launch and get to market, we’ve said even in the past that some of these take four to six quarters, some of them take maybe up to six to eight quarters to reach their peak sales. But you will start seeing the ramp up. You’ll start seeing the numbers play in into the P and L as products start taking traction.
Fiscal 27 is the first time that you will see some of these launches that we did in 26 begin to play out as the numbers get into the quarters. So that is as far as we can go because it’s hard to give a quarter by quarter prediction on how every launch in every market will play out. It’s number one. I didn’t quite follow your question on the European piece. We are looking to grow the European market as well. This particular quarter you heard Kedar say that we’ve prioritized profitability. We’ve looked at higher margins which is deflected in the financials.
But we see demand across regions and as more products come online you will see all our regions, North America, Europe and even the rest of the world emerging markets show a very strong growth there. Is that expected to happen? And the third piece which you were referring to in terms of what our market shares have been, I think they’ve been very strong. Kiran in our opening remarks mentioned that our and we can refer to them as legacy products continue to have over a fourth of the market in oncology products that we launched back in 2018.
So I think we’ve continued to hold that market share, continue to be profitable again reflected in the numbers. And if you look at the European trends again in oncology we were under 6%. Now those are trending in double digits again. So clearly demands strong and as we look at the coming quarters supply will grow as well as we qualify more facilities. So all in all quite promising when the coming quarters look like. I hope I responded to all your questions.
operator
Thanks Shreyas. Just one follow up on that and sorry, one additional question on Semaglutide in India. Right. Given the prior transactions with Aries etc, what is the, what is the play in India looking like from biocon’s perspective for Semaglutide?
Kiran Mazumdar Shaw — Executive Chairperson
Maybe Siddharth, you want to come in.
Kiran Mazumdar Shaw — Executive Chairperson
And respond to that? Thanks.
Shreehas P Tambe — Deputy Chief Executive Officer, Biocon Biologics Limited
So I think you know what we have heard other companies talk that of course there have been approvals and they’re going to launch the product soon. And the pricing here will be very competitive compared to global pricing. So we do have our clinical approval approval to start our phase 3 clinical in India and our strategy typically in India is through a partner since we had divested our business, the branded formulations business to eris. You know our we did tie up for liraglutide with two other companies in India. One of the the partners had launched the product last year through a reusable pen.
And if we do a clinical trial in India and if we do still see a good economical value and return on the clinical investment then of course the go to market strategy will be through a partner. But I think let me tell you that India is one of the only Markets in the world where you need a full blown clinical trial, unlike Europe, US and other markets where you don’t need clinical trial. That’s why it’s a, it’s a decision whether we wait for one of the ICH country approval and then apply for a clinical waiver like we did for liraglutide versus spending that money which is not small, it’s a significant investment in Phase 3 clinical.
So that decision will be taken and if one way or the other we will apply for marketing approval in India in due course and the commercialization will be through a B2B partner.
Shyam Srinivasan — Analyst
Thanks, that was helpful.
operator
Vishal, can we take the last two questions please?
operator
Sure, sir. Yes. Yes sir. Ladies and gentlemen, we’ll be taking last two questions in the interest of time. The next question is from Vishal Manchanda. Please introduce yourself and proceed with your question.
Vishal Manchanda — Analyst
Good morning, this is Vishal from Systematics Institutional equities on Adalimumab. Could you give a timeline as to when the regulatory process and tech transfer can get completed and broadly the rationale for doing this? Deep.
Kedar Upadhye — Chief Financial Officer
If I may respond to that question. You know, Damendi had probably a similar question and we did respond on the rationale so I can go through it if needed again. But clearly we have much better control on the product now, Vishal. We have end to end integration that allows us to do more with that asset than we were able to until now. It’s a very important product in our portfolio. So that rationale is something that is very strong and continues to guide our investment in the asset in terms of how it’s going on. Tech transfer is already initiated.
It will happen in phases because there’s an element of the device, there’s an element of the, the syringe itself which is on, these are on the drug product side and there’s the element which is related to tech transferring the clone and the, and the drug substance and all of these are going on and we will work with regulators globally to see that these things evolve. There’s a close coordination and collaboration with FKB in Japan and, and this is a process that is more collaborative than hands off. So we expect this to, to happen in a, in a very collaborative manner.
Vishal Manchanda — Analyst
Thank you. And just one more on AP. Just wanted a clarification whether we own 100% of the rights here or we’ll have to give out some profit share. To JNJ or Momenta. Maybe you want to come in on this one Vishal.
Kedar Upadhye — Chief Financial Officer
The whatever the royalty or what, there’s no profit here. There’s a small royalty. We are not, we are not public about the Quantum, but it’s not very significant.
Vishal Manchanda — Analyst
Understood, thank you. That’s all from myself.
operator
Thank you. This will be the last question for today, which is from Vipul Kumar Shah. Please introduce your. I’m sorry, this will be the last question for today, which is from Abdul Kadar Puranwala. Please introduce yourself and proceed to the question. Sir.
Abdulkader Puranwala — Analyst
Yeah, hi. Thank you for the opportunity. Just two questions from my end. First on the generic space. So no, Nordisk is now talking about launching vials in next year citing generic threads. So how do we perceive this and you know, versus the investments, what we have done currently?
Prashant Nair — Head, Investor Relations
If the Innovator does launch a different format or different form of formulation, we will of course assess whether we need to develop it and for which market. And I think the disposable pen is what’s the standard in most developed markets, U.S. and Europe. And they might have a different strategy for emerging markets. And I think at this stage will be difficult to comment, but we will of course track what makes more sense.
Abdulkader Puranwala — Analyst
Understood. And just a final one on your biosimilar growth. So sorry for hampering on this, but if you look at the 9 monthly number of 17%, would it be possible to split this across older products versus the new products what you have launched in the last six to nine months?
Kedar Upadhye — Chief Financial Officer
Yeah. Abdul, the. As we have explained in the past, the scale up of biosimilars is a bit staggered over multiple quarters. So large part of the growth that we have demonstrated in the nine months is based upon the strength of existing franchise.
Abdulkader Puranwala — Analyst
Got it. Ker, thank you for the clarification.
Kedar Upadhye — Chief Financial Officer
Yeah.
operator
We’Ll take one more last question for the day which is from Vipul Kumar Shah. Please introduce yourself and proceed with your question.
Vipul Kumar Shah — Analyst
Thanks for the opportunity. I’m an individual investor. So you named. You have four molecules with 200 million dollar plus revenue. So can you name them? Is it possible to name them? And second question is we were pursuing oral insulin program long back, so are we still pursuing it or we have dropped it? So let me first answer the first question and then Kedar can answer the second. Your other question about which are the four molecules that have crossed 200 million as far as oral insulin is concerned, physiologically it worked, but financially it didn’t make sense because insulin is a very low cost product from that point of view and to make it work it was going to cost a lot more.
So financially it was not viable and hence we dropped the program.
operator
Thanks, Kiram. We pulled the four molecules we have named last year. So I think Prostuzumab, peg, Filgrastine, insulin, franchise including Glarazine and Adalimumab. These are the four molecules which have crossed 200 million in FY25 and Kedar.
operator
Last question. What is the debt reduction roadmap?
Siddharth Mittal — Chief Executive Officer and Managing Director
Yeah. So in the last two quarters from June till now you have seen all the structured debt getting retired and cumulatively that will be upwards of almost 550 to 600 million dollars. So that has happened now the date ratios have improved. You have seen upgrade from both S and P and Fitch. So we are happy about it. And effectively what remains is you know the date that we owe to bondholders and syndicated loan that you know we are on the journey for reduction in the subsequent quarters based upon organic cash flow generation.
Kedar Upadhye — Chief Financial Officer
Same 500 million reduction can be expected in next financial year.
operator
See we are not quantifying and in one year such a large quantum is not possible. But look, that’s our one of the biggest and top priorities.
Shyam Srinivasan — Analyst
So net debt is how much last.
Prashant Nair — Head, Investor Relations
Yeah, like what I explained.
Kiran Mazumdar Shaw — Executive Chairperson
I think you should Vipulji, you should actually look at what is your reduction of debt EBITDA ratio. I think if you look at it it has come down substantially. It is now below 2.5x and I think what we will look at is to see how we can take that down further. Thank you madam.
operator
Thank you. As that was the last question for today I would now like to hand the conference over to Mr. Prashant Nair for closing comments. Thank you. And over to you sir.
operator
Thank you Michelle. And thanks everyone for joining the call. If there are any questions unanswered, please get in touch with the IR team. Thank you.
Neha Manpuria — Analyst
Thank you.
operator
Thank you members of the management. Thank you ma’. Am. On behalf of Biocon limited that concludes this conference. Thank you for joining us and you may exit the meeting now. Thank you.