Good morning, everyone. I'm Saurabh Paliwal from Biocon Investor Relations team, and I would like to welcome you to Biocon's earnings call for the first quarter of fiscal year 25. I would like to indicate that all participant lines are in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks conclude. Should you need any help, please use the Raise Hand option and the Reactions tab. We will call out your name and unmute your line to ask, to enable you to ask a question. While asking, we request you to please begin with your name and your organization. Please note that the chat box is disabled, but you can raise any technical issues by sending us an email at investor.relations@biocon.com. I would like to bring to your notice that this conference call is being recorded.
The recording will be made available on the website within a day, and the transcript will be made available subsequently. Moving to discuss the company's business performance and outlook for, you know, during this quarter, we have on this call our Group CEO, Mr. Peter Bains, Mr. Siddharth Mittal, CEO and MD of Biocon Limited, Mr. Shreehas Tambe, CEO and MD of Biocon Biologics Limited, along with other senior management colleagues across our business segments. Before we begin, I want to remind everyone about the safe harbor related to today's investor call. Comments made during the call may be forward-looking in nature based on management's current beliefs and expectations. They 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.
After the end of this call, if you need any further information or clarifications, please reach out to the investor relations team. With that, I would like to turn the call over to our Group CEO, Mr. Peter Bains, for his opening remarks. Over to you, Peter.
Thank you, Saurabh, and good morning, everyone. Before presenting the results in detail, I'd like to start with some opening remarks. As you will see and hear, on a reported basis, the comparable or year-on-year first quarter group financial performance has come in very strongly, with total revenue up 30%, EBITDA up 117%, and PBT up over 500%. This performance has been driven by the impact of the Eris Lifesciences business transfer, consummated in the quarter. After adjusting for the Eris transaction, underlying group financial performance, while relatively subdued, has come in in line with our expectations and our previous guidance, and this is reflecting a mix of headwinds and tailwinds across our businesses. The highlight was the biosimilars business, which has delivered a strong like-for-like operating revenue growth, which has offset degrowth in the generics business and in Syngene.
In line with our previous guidance, we expect the Quarter One trends to continue into Quarter Two before we see a transition toward accelerating growth across the businesses through the second half of the fiscal year and into next year. I will now move on to present the financial highlights for the quarter. At the group level, total revenue was INR 4,567 crore, a growth of 30% year-on-year and 15% on a sequential basis. As I've said, this included proceeds amounting to INR 1,057 crore from the strategic business transfer agreement with Eris Lifesciences, which is classified as other income. Revenue from operations, which excludes income from the Eris Lifesciences transaction, was INR 3,433 crore, largely flat as compared to last year.
As I've just said, this reflects a balance of performance across the segments, where biosimilars revenue from operations grew 11% on a like-for-like basis, while research services and generics saw declines of 2% and 6% respectively. Group core EBITDA for the quarter stood at INR 903 crore, down 4% year-on-year and representing a core operating margin of 26%. Quarterly R&D investment spend stood at INR 228 crore, corresponding to 9% of revenues, excluding Syngene. Reported EBITDA for the quarter stood at INR 1,755 crore, up 117% year-on-year, with a margin of 38%. Adjusting for the income from the Eris transaction, EBITDA for the quarter was INR 698 crore, with an EBITDA margin of 20%.
Profit before tax and exceptional items stood at INR 1,114 crore versus INR 184 crore last year, and adjusted for the Eris transaction flow-through, PBT for the quarter stands at INR 57 crore. Net profit that was reported for the quarter was INR 660 crore, while adjusted net profit stands at INR 19 crore. Let me now turn to the business segment highlights and start with generics. Revenue from operations in generics was INR 659 crore, a degrowth of 6% year-on-year. Core EBITDA for the quarter was INR 123 crore, with a margin of 18%, and R&D spends at INR 64 crore, and representing 10% of segment revenues, was up by INR 10 crore for the same period last year, reflecting our continued investment in our strategic peptide and injectable portfolios.
EBITDA for the quarter stood at INR 59 crore, with a margin of 9%, reflecting lower sales, price erosion, and the increase in R&D investments seen during the quarter. Profit before tax stood at INR 17 crore, with a PBT margin of 3%. Overall, while the performance for the quarter was muted, it was in line with our expectations, reflecting the anticipated pricing and demand challenges across our API and formulations-based business. Moving now to look at the business updates, let me start with business development, and here our preparations for entry into the GLP market opportunities are continuing to build momentum, and we were very pleased to sign an exclusive licensing and supply agreement with Handok, a leading specialty pharmaceutical company in South Korea, for the commercialization of our synthetic liraglutide for the treatment of chronic weight management.
This is consistent with our commercial strategy of expanding our global footprint beyond our direct presence in the United States into other important geographies, including the UK, Europe, Latin America, Asia, and Australia, either through direct presence or working with strong local strategic partners. On the regulatory front, there has been significant activity and progress, with 17 market filings, including two ANDAs in the United States, and we have received three approvals, including our first generic injectable drug product approval for micafungin in the United States. In June, the US FDA conducted GMP and PAI inspections at two of our API facilities, Sites 5 and the new Site 6, both located in Vizag. These inspections resulted in the FDA citing four and three observations, respectively, which were procedural in nature.
The company responded to the agency's observations within the stipulated timelines for both inspections, and I'm very happy to report that earlier this week, the FDA issued an establishment inspection report for Site 5 and classified the inspection as VAI, or voluntary action indicated. We now await agency feedback for Site 6. In June, the Brazilian Health agency, ANVISA, conducted a regulatory audit of our oral solid dose facility in Bengaluru, which concluded with no major or critical observations. Looking ahead for the generics business, and consistent with previous guidance, we expect the second quarter to continue to be relatively muted, with performance then building in the second half of the fiscal, led by new generic formulation launches across multiple markets. Importantly, this includes the launch of our liraglutide formulations for diabetes and obesity, both in the UK and in other markets, where preparations are well underway.
Our extensive GLP portfolio, led by liraglutide, will be the major growth driver for generics in the coming years and has strong synergies and complementarity with our global insulins business in our biosimilars vertical, providing Biocon a unique positioning in addressing the strategic diabetes and obesity global market opportunities ahead. Let me now move on to our biosimilars vertical. While our focus in fiscal 2024 was ensuring business continuity and preserving value during the transition phase post-acquisition, our focus in FY 2025 has now shifted to consolidation and leverage of our unique vertically integrated model to drive profitable growth. I'm pleased to say we began the year on a positive note with a robust 11% like-for-like growth in Q1 and achieved several key regulatory milestones. In the United States, we continue to see strong demand across our product range.
In our oncology franchise, Fulphila, our biosimilar pegfilgrastim, and Ogivri, our biosimilar trastuzumab, continue to hold strong market shares of 20% and 19% respectively, with several market access agreements coming into effect and increased pull-through at the physician level from our marketing team. Our Semglee and insulin glargine franchise, serving the diabetes market segment, also holds mid-teen shares on the back of strong formulary coverage, including a large managed care network. The U.S. insulin landscape continues to evolve dynamically, and we believe we are very well positioned with our extensive heritage and expertise in insulins to exploit and capitalize on the emerging opportunities. In Europe, our market shares have remained stable at the regional level, with some strong performances in several key markets.
Hulio, our biosimilar adalimumab, is the market leader in Germany, and on the oncology front, our Ogivri, Fulphila, and our Abevmy, biosimilar bevacizumab products have captured double-digit market shares in key markets such as France and Italy. We are also making good progress on our business expansion strategy in Europe, with new launches and tender wins at national and hospital level in markets such as the United Kingdom and Italy. Our emerging markets business reported a strong performance on the back of higher sales of our biosimilar bevacizumab, recombinant insulin, and, etanercept. During the quarter, we expanded the depth and breadth of our reach through 12 new product market launches.
Now, coming to the financials for the first quarter of fiscal 2025, biosimilar revenue from operations was INR 2,083 crore, up 11% on a like-for-like basis, adjusting for revenues in Q1 fiscal 2024 from the branded formulations unit in India. Revenue from operations does not include the income from the Eris agreement, which is booked as other income. This growth translated into a core EBITDA of INR 614 crore, with a margin of 30% and an EBITDA of INR 474 crore, or 23%, reflecting the strong underlying profitability of the core business. We continue to invest in our pipeline, with R&D spends at 8% of revenue, to drive the mid- and long-term growth of the business. Profit before tax is INR 1,065 crore, including the gain from the Eris agreement.
Moving on to regulatory updates, there have been significant activity and progress. The US FDA approved Yesafili, our biosimilar aflibercept, as the first interchangeable biosimilar, which marks our entry into ophthalmology, a new and exciting therapeutic area. Our biosimilar denosumab global clinical trial has met the required endpoints, and we are currently on track to submit regulatory filings later this year. The European Medicines Agency has renewed its Good Manufacturing Practice, GMP, certificates of compliance for both our Bengaluru and Malaysia sites. We have also received EMA approval to manufacture our biosimilar bevacizumab at our new monoclonal antibodies drug substance facility in Bengaluru. The same facility has also received GMP certification from the Therapeutic Goods Administration, TGA, the regulator in Australia.
The U.S. FDA recently concluded a combined GMP and pre-licensing inspection at our facilities at Biocon Park, Bengaluru, between July the 24th and the end of the month, spanning six manufacturing units and the associated quality labs and warehouses. The 10 observations noted in the Form 483 were procedural in nature. There were no observations related to data integrity or on quality oversight at any of the facilities, and no repeat observations were noted by the agency during inspections. We will submit a comprehensive corrective and preventative action plan to the agency within the stipulated time frame and are confident of addressing these observations expeditiously. We do not expect the outcome of these inspections to impact the supplies of our commercial products. Finally, coming to Syngene.
In Syngene, we saw revenue from operations for the quarter down marginally over last year at INR 790 crore. Reported EBITDA was down 20% to INR 188 crore, with an EBITDA margin at 23%. Profit before tax at INR 69 crore was down 44% from last year. Overall, Syngene's first quarter performance is in line with its guidance and commentary given in its Q4 fiscal results presentation. The dedicated centers reported steady performance, while there were continued growth momentum in biologics manufacturing, driven by both commercial as well as clinical scale projects. Performance in discovery services was impacted by the dip we've seen in US biotech funding that has impacted the sector over the last two years.
However, it's clear that green shoots are now on the horizon as the value of funding to U.S. biotech saw a marked increase in the first half of calendar 2024, which will generally flow into outsourcing demand with a lag of a few quarters. Requests for proposals are up 50% year-on-year, with the first quarter of fiscal 2025 being the best first quarter for RFPs for Syngene in four years.... This quarter also saw the start of several pilot projects from pharma companies. Successful delivery of these projects is expected to build a foundation for larger scale future collaborations, and Syngene expects to win its fair share of these pilot projects. Increased visits by companies exploring outsourcing options beyond China add to the positive future outlook and provides long-term tailwinds for Syngene.
The repurposing of the biologics manufacturing facility acquired from Stelis Biopharma remains on track for completion of qualification and facility modifications in the second half of fiscal 2025. So to conclude, overall, the underlying operational group performance delivery in the first quarter, while largely flat, has reflected the balance of a strong biosimilars performance, offsetting transitory degrowth in generics and in Syngene. This is consistent with our earlier stated guidance and is in line with our expectation. Performance in the second quarter is expected to largely mirror that seen in the first quarter.
In the second half of the year, and as previously guided, we expect to see a transition to accelerated growth, underpinned by continued traction in biosimilars, new product launches in generics, and Syngene being in a strong position to capitalize on the emerging trends in its business to hit its guidance range for the year, and with momentum expected to build in the second half. I'd now like to conclude my opening remarks and open the floor to questions.
Thank you, Peter. We'll wait a couple of minutes for the question queue to assemble. Once again, if you want to ask a question, please use the Raise Hand option in your Zoom application. We'll take the first question from Amey Chalke. Please go ahead.
Amy, I think you're on mute, if you're asking a question.
Yeah. Am I audible now?
You are now, Amey. Thank you.
Yeah. Thank you for giving me the opportunity, and thank you for the elaborative presentation on the quarter. The first question I have is on the biosimilars. I agree that we are marketing... We are increasing market share quarter-on-quarter in the existing products in the U.S. But should we assume the similar improvement happening on the value of these products? Basically, how is the pricing tracking in these biosimilars vis-à-vis the market share change?
Thank you for the question, Amey. I'm going to ask Shreehas to lead the response, for that question, please.
Thanks. Thanks, Peter. Thanks, Amy, for the question. I think the good part is that the biosimilars opportunity that we are seeing overall in all markets, whether it is North America, Europe, or in emerging markets, seems to be very strong. It's shown strong growth for all our products in all geographies. And if you specifically asked on the pricing front, we are looking at a more stable pricing across regions. In the U.S., we have seen that biosimilars have held on to their price, particularly those in the oncology space, for over five years, and this continue to hold value. So there is, of course, a competitive dynamics which will play off, but we expect a much more stable price pricing regimen than the other markets that are there.
We expect this to be a very stable market, overall, Amey.
So, should we assume an increase in our existing biosimilar products with respect to the volume share changes?
We probably lost you in between on the audio, but your, your question, if I understood correctly, was that how do we see this in terms of market shares playing out in the, in the future? Is that your question, Amey?
What I'm asking is, should we assume the value gain in these products, correspondingly the market share gain which is happening in these products, basically?
Yeah, the-
Should we assume that sales to be increasing? Yeah. Yeah.
Yeah, I think the way you would expect is that there will competitive dynamics will play out across markets as product mature. But we really feel that, you know, given the increased market shares, there will be a growth in the products and the revenues. Pricing will, of course, erode over a period of time. That's a, that's a, you know, expectation that we should all have of of any market for any product. But it's a much more gradual price decline, and the market share should really be a good indicator of product acceptance and performance.
Sure. So a second question I have is on the Hulio. Basically, our expectation was in FY 25, the market landscape will move towards generic. If you can give some color on the market development here in the Humira market, Humira biosimilar market. Thank you so much. I will join back with you.
Peter, if I can just go into this, and then I'll have Matt join me as well, for this answer. I mean, if you, if you go back to the commentary that we had shared on how we see this market evolving, we have said it's a three-stage evolution, where we had said, calendar 2023 is when the market opens up, which is when everyone got in. 2024 is when we said the market, and that was calendar 2024, is when we said market will start to see traction towards biosimilars. Then 2025 is when the opportunity really opens up from a calendar year perspective.
What we are seeing right now in the U.S., is that you are seeing biosimilars starting to take market share, although still, a large part of the market is with the originator. But we clearly see that it will move in the direction that we have guided in the past. I would like, Matt, of course, to add more color to this, in terms of how it shaped in 2024 and how we see this evolving in 2025. So, Matt, would you like to please comment?
Sure. Thank you, Shreehas. So a little more color around this is that we are starting to see the biosimilars. You can see this starting to take off, but it's relatively just with one large U.S. payer, and that large U.S. payer is primarily using their private label, which is very publicly what's going on. The other two large U.S. payers currently still have Humira on their formulary. As Shreehas stated, we do see this as a second half of FY 2025 opening up, and we're in a position right now bidding these products, and we feel that we've got a great opportunity as we look towards the second half in meeting our expectations that we've laid out. Thank you, Shreehas.
Sure. If I can add the supplementary question. So, assuming that then the Humira will get developed in the second half, is there any change in our guidance for this year, considering if there is any delay on the new product launches?
Shreehas, again, I think that's—
Yeah. Thanks . I mean, we've not provided any guidance on the numbers at this point, to my knowledge. The way we see this is that, given that for adalimumab, we are in a very good position, that we are integrated. We have a history of commercializing this product since 2018. I would like to point you towards our leading market share position in Europe, where we have successfully had this product in the market for a very, very long time. So we believe that this will play out in our favor as the market in the U.S. matures, and we see this market consolidating over a period of time.
Sure. Thank you so much. I will join back the queue.
Thank you, Amey. We'll take the next question from Tushar Manudhane from Motilal Oswal. Tushar, your line is-
Am I audible?
Yes.
Yes.
Thank you for the opportunity. Sir, with respect to this inspection at Bengaluru, while the response has been submitted, can you share the timeline for implementation of the measures?
Thank you, Tushar. Let me again give that to Shreehas, to perhaps, perhaps get someone from his team to reply.
Yeah. Thanks, and then, Tushar, thanks for your question. We, as Peter explained in his opening comments, we did have the inspection from the agency last month, and we are in the process of responding to the agency with a very comprehensive CAPA plan. And that is within the stipulated timeline. So once we've done that, we should be in a position to outline next steps.
Any broad timeline you would want to share to implementation, or is the approvals of the product will be subject to the implementation of the CAPA?
So, like every inspection, you know, once the inspection is done, the company is expected to provide a response to the observations. These observations are what the inspectors note during their time at the facility. We have noted those observations, and we will be responding to this. The agency typically reviews this in a time frame, but there is no guidance that they have in terms of when they will revert back to us. We expect them to come back typically in the 60-to-90-day time frame, but there is no real time frame that is defined for this, so it would be incorrect to comment on behalf of the agency.
Sure, sir. Progress on the Malaysia side, from a compliance point of view?
Yeah. On the Malaysia side, we are in the... We have responded to the observations that the agency had made, and we will be looking forward to them scheduling an inspection for us to move forward on that.
So effectively, that would also, as a timeline, three to five months can be considering the, I mean, the inspection timeline for Malaysia side?
Tushar, it would be hard to comment on behalf of the agency when they would come or whether they would need an inspection, once they have, you know, concluded on the Bengaluru inspection. So I wouldn't hazard right now a timeline on it, but I can tell you that we are in constant conversation with the agency, and we will provide them with whatever is required for them to assess the readiness of this site to supply new products. I should also point out to you that we continue to supply large amounts of products to the United States from this site, and all other regulatory agencies, including EMA, most recently, have approved our facility in Malaysia and in India.
Awesome, sure. And just lastly, on this, generics, generic liraglutide and considering the business prospects for Biocon generics, how do we see, like, what kind of scale-up can be expected? If you could quantify, let's say second half FY 2025, we expect this business to scale up. And if you could also elaborate on the liraglutide opportunity per se.
Thank you, Tushar. Sid, perhaps you could address that question.
Sure. So Tushar, I think as we've indicated earlier, and Peter mentioned in his opening comments, that we have various markets where we have done the filings. We expect the approval, you know, from European authority later part of this fiscal. We've already got a launch coming up in the UK through our partners, Zentiva, as well as under our own label. And there are various other markets where we expect to launch the product during this fiscal year. The GLP-1 franchise is a very important part of our growth story for next couple of years. As you know, there's a huge opportunity in GLP-1 space both in diabetes and obesity management. And we are very well placed in capturing the benefits of this large opportunity.
In terms of specific numbers or guidance, in terms of what the growth is, I think it'll be a bit difficult for us to give that. But definitely the first half will continue to be muted, as we have seen in first quarter, but second half, we will see a good growth over first half. Second half will be a significant growth over first half. But the overall year, we still expect like a high single digit kind of growth levels for the business.
Understood, sir.
Tushar, if I may then just add in a little bit on top of that, to amplify something I said in my opening remarks. Obviously, the GLP peptide opportunity is, it's the strategic growth driver for generics in the coming years and will play into a huge market opportunity being formed by the innovators over the coming years and decade. I think it's important for me just to emphasize here, this is an area of very, very strong group complementarity and synergies, as the peptides where we're scaling for global market opportunity complements and has many synergies with the global insulins franchise that we've built in the biosimilars.
Quite clearly, as we look at this opportunity in both diabetes and obesity, we see Biocon being very uniquely positioned with its heritage position in insulin and its leading position in the generic peptides business to you know, to, to look at leveraging these synergies, these complementarities, these convergences, you know, to, to drive a very unique opportunity here for the group.
Awesome. Sid, just one more on this. As far as API capacity is concerned, do we have sufficient capacity to cater at least for next couple of years, or would we need further investment for liraglutide API?
So we do have initial set of capacities that we had created, and we are expanding those capacities, which will be sufficient for the next couple of years. But of course, the big drug, which is semaglutide, goes off patent beyond 2030, in many of the large developed markets. And for that, we will of course add on more capacities over a period of time. But to the volume of business that we are targeting over the next five years, we will have capacities by end of this year.
Understood, sir. Thank you. Thank you so much.
Thanks, Tushar. We'll take the next question from Neha Manpuria from Bank of America.
Thank you so much. Just to understand the BBL business a little bit more on a quarter-on-quarter basis. There seems to be a fairly sharp decline. I'm assuming a large part of this is because of the divestment. So if you could just give us some color in terms of how much of that decline that we're seeing quarter-on-quarter is because of the India business divestment versus, let's say, underlying business trends.
Shreehas?
Yeah. No, Neha, thanks for pointing it out, and Kedar, please feel free to jump in on that. I think as, Neha, as Peter outlined in his opening comments, the quarter-on-quarter decline, which you are seeing is, one, is to adjust for the branded formulation business, which is a discontinued business-
Mm-hmm.
that we've seen, and that's a clear change, so the baseline is different.
Mm-hmm.
The other piece, of course, is that, you will see a cyclical nature in terms of, how tenders will open up over the over the different emerging markets, and you will see a strong growth usually in, in the quarter four before you get into quarter one, so that is what you are seeing. But I do want to point you towards, you know, the performance of the business over last quarter in fiscal 2024 over 2025, and there you can see that there's a very strong growth in the product performance, and that is a 19% increase over the product performance and market share that has driven it. So if you look at how the products have performed in the market, there's a very strong uptick of the market.
The cyclical nature of this will, will mean that between quarters, you will have, you know, movements where quarter four could be higher than quarter one, particularly in emerging markets. But in North America, you see a steady performance across quarters, and you will see some minor movements in Europe, where also there are, large dependencies on tender timing. The chronic therapy areas that we operate in actually allows us a natural buffer and a hedge towards some of this, but the tender opening cycles in different markets, will cause some of these differences and lumpiness between quarters. But otherwise, we see this, you know, moving in the right trajectory.
Is it fair to assume, Shreehas, that the emerging market piece should continue to grow, you know, mid-teens, high teens? It's just a matter of the tender phasing between quarters, but the underlying growth is still in line with the trends that we're seeing for the biosimilar business overall?
Yeah. We've seen a strong uptick across markets. It's not just that we have seen growth in North America. The emerging markets is a growth area for us, Neha. So it is, quarter on quarter, sequentially, you might see that there is some, you know, some movement between quarters because of, as I said, you know, when tenders open and when supplies begin. But otherwise, on an annualized basis, you will see that across markets, our performances will be, you know, pretty, pretty strong.
Understood. And my second question is on aflibercept. Now we have the US FDA approval. Obviously, the lower court litigation didn't go our way. You know, what is the timelines that we need to monitor on this for the appeals, appeal for the, this one, and therefore, does the timeline of launch, based on how you're thinking about the appeal?
Yeah, and, and aflibercept is an important asset that you draw attention to, and it is, it's an exciting asset. It has over $10 billion of sales globally in innovator, you know, revenue, so it's clearly a very exciting asset. We have a first to file status, we have a first to approval status as an interchangeable aflibercept, so we feel very good about it. We have already secured approval for this product in Canada, in, in the U.K., in Europe, and now, most recently in the U.S. as well. So we are in a good place, scientifically and in the ability to begin supplies. We recently also announced that in Canada, we will be supplying product come July of next year, which will be the first in that market.
We are, of course, in litigation with the innovator in the United States. As things progress there, we will be able to talk more about it. Given that we are in a litigation right now, Neha, it wouldn't be appropriate to comment on this. I know you made a comment on how the litigation in the district court played out. There were three patents that were litigated.
Yeah.
Two were ruled in our favor, one wasn't ruled in our favor, which of course, we will, you know, take up appropriately, so that we can, you know, get to the, to the patients as soon as that is behind us. So we're working on that.
Thanks so much. And, one last question, if I can squeeze in. What is the net debt position, in this quarter for the, for BBL as well as the consolidated entity? And, you know, if you could give us some color on, likely repayments, you know, in the next year.
Kedar, would you like to take that question, then respond to Neha?
Yeah, yeah, sure. So, Neha, the net debt for BBL is about INR 1.2 billion, slightly higher than INR 1.2 billion. You would see a sequential improvement because of working capital efficiencies, which have come in this quarter. And, I mean, Saurabh can sort of clarify the net debt at the group level. But at BBL, it's about INR 1.2 billion plus, as I clarified, with some incremental efficiency in this quarter. You know, with respect to the repayments, I think there is a schedule of repayment that we have agreed. And, as you would expect any company to do, we are also thinking about ways to optimize both the repayment timelines and the interest rates as well. So we are thinking about various options to get that sorted out.
Thank you, Kedar.
Neha, let me just add on to that, to build on what Kedar said. You know, we, we've obviously been comfortably servicing, you know, what, our debt position, to date. We've made clear that we are looking to reduce it. We've taken action last year, reducing acquisition debt by $250 million. It's a clear management priority that we will look to continue to reduce that debt level, and, you know, we have a wide range of options available to do that, and I'm sure we'll take further action during the year.
Thank you, Peter. Saurabh, if I can get the net debt number on the consolidated level, please?
Yeah. So net debt at the consolidated level will be about INR 1.1 billion plus.
Okay. Thank you so much.
Thanks, Neha. We'll take the next question from Surya Patra, from PhillipCapital.
Yeah. Hello, am I audible?
Yes, you are, Surya.
Thank you, sir. Thanks for the opportunity. Sir, my first question is on the aflibercept only. You have discussed about the potential U.S. opportunity and all. Particularly, possibly that commercial benefit can flow in Europe first. Could you share what is your competitive positioning there, considering the multiple approval already? And when do you think that benefit can start flowing in for us?
Shreehas, again, I think, if you could take that.
Yeah. Thanks, Surya, for that question. I think, just a couple of clarifications. I wouldn't speculate which market will open up first, other than the fact that Canada, we have a very clear market entry date, and we are the first to enter there. So that is one clarity. We do not also think, Surya, that, to our knowledge, there are multiple other players who have got approval. I'm sure there are multiple players developing the asset, so there will be. Given that the ticket size is large, we expect competition to be there.
We believe we are very well-placed, given our advantage, in terms of the timing and our position in the market, given that we are present in the market as a fully integrated player. We believe that we should be able to provide an option to patients sooner and in a much more efficient manner than has been available so far.
So just an extension to this, is a one-year exclusivity opportunity because it is a interchangeable one in the US, that will, that will be ensured to us, given the two other player have also got the approval for US?
So I think the interchangeability approval, the exclusive part that you talk about, Surya, is something that is a exclusivity to claim interchangeability. It is not like a exclusivity to commercialize the product like you have in a 505(b)(2) or a ANDA kind of an exclusivity, where you have the ability to supply the market exclusively. I think this is more of your ability to claim interchangeability on an exclusive basis. So yes, we will have that for a period of 12 months. And once we've got the product to the market, we will look to explore that.
Sir, my second question is on the adalimumab. In fact, two points that I wanted to clarify here. First is that, given the kind of contract that we have signed, that is what we have indicated. So based on this, is there a possibility to share that, okay, what are the kind of volumes here that we could be thinking about, let's say, for FY 25 or FY 26, whichever way that you can possibly share that? That is one. And secondly, an interesting development that happened during this quarter, relating to adalimumab, that one of your competing partner, or competing peer in the adalimumab, has exited out of the opportunity by selling all their rights just for $40 million.
Whether it is a worrisome factor for the entire biosimilar opportunity, and in the U.S. market, the way things are happening about the progression of the biosimilars and all that, if you can share your view on these two aspects about relating to adalimumab, then that would be useful, sir.
Yeah, I think both are great questions, Surya. Let me respond to that. The first is we've not given guidance in terms of our projections in the past, and we continue to stay with this. It is, it's not advisable to give guidance on market shares. We will let you know as market evolves, and we will see how that progresses. So I will refrain from commenting on market shares. The second question that you talked about, which was you've seen a player, a particular player exit the market by monetizing that asset and moving on.
I think this is, you know, in line with the commentary that we had shared in the past, that we do not see this market as an 8, 9, 10-player market for a long time. We expect this market to consolidate, and we expect those players which will, those will have the ability to endure over a period of time, which requires you to be fully integrated. The ability to, to be in control of, your development, your manufacturing, and your ability to supply the market, through a strong commercial force. I think that is really what will allow you the, the ability to be in the market for long. And we believe Biocon Biologics, has that now, you know, post-integration of the business that we acquired from Viatris. We believe we are in this for the long run.
So, Surya, that is what we see happening. And we look at this as what was along expected lines.
Sure, sir. Just one clarification from Kedar. The staff cost this quarter is meaningfully up. So is it entirely because of the field force responsibility or the kind of marketing responsibility that you have taken up from Viatris from last quarter? It is entirely because of that, and hence it is, this is the kind of run rate going ahead per quarter?
Yes, Surya, you're right. I think the stock cost was expected to go up to reflect the full quarter effect of the, the leads who have come over from Viatris. So that was expected, and that's in line with plan. You could see a similar reverse switch, by the way, in other expenses. That has come down. So in fact, if you would have noticed in quarter three and quarter four, the spend run rate was touching $100 million for biologics. That has come down to $90 million, as we had planned.
... Okay.
So staff cost was expected to go up, and it has gone up to reflect the full quarter effect of manning of colleagues who have come over to us. But overall costs are down by 10% compared to the peak.
Okay. Then, on the margin front. Sorry, I'm just extending this point again. On the margin front, we have seen a sharp decline this quarter. Maybe it could be just a quarter-specific one, but this is the lowest ever margin over the last five years. How would you address this, Kedar?
Which margin you are referring to, Surya? Is it consolidated, BL, EAT margin, EBITDA margin? Which margin you are referring to, please, so that we can answer your question.
I was looking at the EBITDA margin without factoring the Viatris transaction.
Yeah, so that we had said it is about 23%, and that's consistent with what we reported last year as well. So I think core EBITDA is healthy at 30%, EBITDA is at 23%. And you can't compare the margins for the last 5 years, because before FY 2023, business was different. So the revenue scale was different, and the nature of business was different. So I think we are in line with what we had expected, and we will work through in terms of improvement through revenue and cost levers. But those are not comparable. Last 5 years' margins are not comparable to what we're reporting this quarter.
Sure, sure. Yeah. Thank you.
Thanks, Surya. We'll take the next question from Manoj Bahety from Carnelian Asset Management & Advisors.
Hello.
Go ahead, Manoj.
Thanks. Thanks for taking my question. I have just one question for Kedar. If you can highlight various capital raising options which we are considering and any timelines around that to deleverage our balance sheet. What's the plan to deleverage the balance sheet in next one, two years?
So, Manoj, I will make a first attempt, and I'll request Peter from a group standpoint to sort of clarify as well. As you can expect that a company of this scale and company of this capital structure will, will have several avenues at our disposal to conduct financing activities. Those activities help us improve our costs of financing, appropriate capital structure and maturities and all that. I think you should expect us, like any other company in our situation would do, to be active on that front. But it's going to be difficult for us to give you specifics unless those are officially approved by board and in a position to be announced.
Sure.
So I'll pause there, and maybe, Peter, you can-
Yeah. Thank you, Kedar. Let me build on that. Thank you, Manoj, and as I said earlier, I mean, clearly, we have been comfortably servicing the debt for the last two years related to the acquisition. You know, we continue to be comfortable to do that. We have clearly stated now that, you know, several times, the debt is obviously a management priority, and that we are taking action and will continue to take action to manage and reduce that. So we took action last year, as I said earlier, with a $250 million reduction on the acquisition debt, and we continue to look at ways to manage and reduce the debt.
We will be taking further action this year, but as Kedar has said, you know, we will advise you as and when those opportunities mature.
Thank you. Thanks for taking my question.
Thanks, Manoj. We'll take the next question from Kunal Randeria.
Hi. Good morning, sir. So on this aflibercept interchangeable exclusivity that you are vying for, would it be a shared one or an exclusive one?
So, Kunal, the aflibercept exclusivity is already granted on approval, so it is not something that we are applying for now. And that exclusivity is also part of what the guidance provides for. And it begins only post-commercialization. So it is not, right now, it is not a relevant point. But given that we are the first interchangeable approved biosimilar, yes, you will, you know, certainly look at this when you get the commercialization.
Sure. So when you do commercialize it, it will be just you having the interchangeable exclusivity, right?
We were approved on the same day with another firm, which got an approval along with us, so we will have to see how that plays out.
Sure, sir.
I will keep you posted on that.
Sure. Sure. Sir, just on liraglutide potential, should we sort of assume or believe that the potential is bigger in markets outside of the U.S.?
Sid, would you take that one?
Well, I would not necessarily say it's bigger outside of U.S. U.S. is also a big market. Of course, there's a shift of patients from liraglutide to semaglutide in the U.S. But that said, there are patients, large number of patients, who continue to take liraglutide in the U.S. But the way I look at other markets, especially the MOW markets, there is a huge market expansion potential available when you have a generic liraglutide which will be launched by our partners. And you know, because the semaglutide, which is where most of the patients have moved, is of course priced at a very high level.
... compared to liraglutide, and the monthly treatment cost, what a generic drug will offer will expand the market. So we definitely are working with our partners in various markets, the large MOW markets, to see how there could be an expansion. And Europe continues to be an attractive market for liraglutide as well. So I would say it will be a very evenly distributed as numbers in U.S., Europe and most of the world.
Got it, sir. And just one more, if I can squeeze in. Just one clarification: Is the Stelara launch contingent on your plant clearance by February 2025?
Shreehas?
I think it requires. Thanks, Peter. I think it requires the FDA approval before you can launch.
Sure. So, okay, so let me put it this way, is the FDA approval withheld because of the plant issues?
No, no, it's not. Nothing is withheld right now.
Okay, fine. Thank you.
Thanks, Kunal. We'll take the next question from Amey Chalke, a follow-up. Amey?
Hello. No, all my questions are answered. Thank you so much.
The next question is from Ashish Thavkar from JM Financial.
Hi, yeah, thanks for the opportunity. Sir, are there any timelines to deleverage balance sheet? Because I guess it's eating a lot of the management's bandwidth. So are you putting any certain timelines as to when do you want to deleverage the balance sheet?
Ashish, thank you for that. Again, I'll amplify that we are looking at this as a priority. We intend to take action this year, but I can't be specific on timelines.
Okay. Understandably, obviously, we now have biosimilars, the generic business, the API one. At any point in time, would you want to share some of the business elements? Is that also on your cards, as a go-forward strategy?
So I think we feel that there are strong opportunities in both the biosimilars and the generics business. You know, and there are no plans, you know, that we're looking at to do any divestments.
Thanks. And, ehnd lastly, on Eylea, the injunction that we have, any timelines that you are sharing with the investors?
Shreehas?
We have shared, Ashish, the timelines that we will be looking to launch this in Canada mid-next year. So we've already talked about that. We just discussed that there is an ongoing litigation in the United States, and we will see how it works in Europe and other parts of the world.
Yeah, that's helpful. Thank you so much.
Thank you, Ashish. The next question is from Jamsheed K. You can go ahead. Jamsheed?
Thank you for taking my question. So I would like to know about its ability to be informed about ustekinumab timeline. So in the previous quarter, you have already mentioned the submission in the U.S. So I'd be keen; can you please provide light on the U.S. and E.U. timeline?
Shreehas, would you take that one?
Yeah. Thanks, Peter. I think, Jamsheed, thanks for the question. We had indicated that we have made a submission to the US FDA and to the European authorities already for both these products, and, these products are under review with the agencies. Once they are approved, we have also been able to negotiate a risk-free launch date and agreed settlement date with the innovator for Stelara in the United States. And we will be amongst the first wave of countries launching this early next year, in the last quarter of this fiscal, once we've got the product approval. So that's the status on ustekinumab, Jamsheed.
Yeah, thank you. That was helpful.
Thanks, Jamsheed. We'll take the next question from Rahul Jeewani from IIFL Securities.
Yeah, thanks for taking my question, sir. Hope I am audible.
Yes, you are.
Yeah. Sir, if I'm not wrong, there is a deferred consideration which is payable to Viatris this year, related to the deal and our option to in-license Eylea. So I think that consideration, which is payable to Viatris, is around $335 million. So how are we looking to fund that? And, given that, how are you looking at your debt at the BBL level by the end of this year?
So maybe I'll start and, Kedar, Shreehas, you can add in. I think the first payment that you referred to has already been made. And the second payment that you're referring to, you know, we will address when it's due. So no issues, no problems there. And with regard to the debt in BBL, I think we've addressed that several times with other questions, that it is clearly a priority. We intend, as we did last year, to reduce further. We're exploring a number of options and, you know, as and when those mature, we'll advise. And, you know, other than that, we can't give any more detail or be more specific on what option and what timeline.
... But, you know, we will address that, and I think resolve both any payments due and work to reduce the debt further during the year.
Sure, sir. So essentially, the debt at the BBL level, which we have right now, which is $1.2 billion, that is, after taking into account the first payment, which we have already made to Viatris?
Yes, it would be.
Okay. Sure, sir. That's it from my side. Thank you.
Thank you, Rahul. We'll take the next question from Prachi Pallavi. Please go ahead, Prachi. We are unable to hear you, Prachi.
Are you on mute, Prachi?
Unfortunately, we, you know, we are unable to hear you. We'll move on to the next participant. The next question is from Dhaval Bhalodia, a retail investor.
Hello. Hi, hi, good morning. I had a question regarding the main for the US biosimilar sector. As Peter mentioned, you know, some with major PBM and specialty pharmacy forming their own subsidiary to market their own biosimilar and capturing the significant market share with product like the Humira biosimilar. And in the future, you know, while that may be happening, potentially applying this same strategy for the future product as well. And the remaining major PBM player, I think they are doing the strategic tie-up with other pharma. So, how does, you know, the Biocon plan to capture a profitable market share for its future biosimilar product? Because most of like Stelara or Prolia, they're most of like a retail, retail specialty product.
Shreehas, I think that's one for you and perhaps Matt.
Yeah, and Dhaval, thanks for your question, and it's a very valid one, given what we have seen. And Matt may also join me in responding to this. So what you are basically asking here is what we saw in case of Humira, where we saw one of the PBMs work through a channel which was more like a captive to white label or private label a product which then they can source, and that's been gaining market share. That is certainly one of the things that PBMs have used to capture more share of the pie. That's an activity that we've seen, Dhaval, and that is something that can happen in the market. We are watching this closely.
Not every product will, of course, go through that route, and that is not necessarily a practice that we expect to see happening across every product. But it is something that we are seeing PBMs trying to do to protect a larger share of the pie and get a larger piece of the business. But I'll let Matt talk to you more about this. Matt, over to you. You're on mute, Matt, if you want to-
Thank you, Shreehas. Some other key things, as Shreehas said, it's not just the commercial environment. There's also U.S. government business that's not part of any private pay. There's also closed-door networks that we're very familiar with. There's also the hospital channel. There's quite a few other channels in which we can play in. Certainly, as Biocon, we're competing aggressively in these private labels. As you know, there's only one that's been really established. We are seeing some, some foothold taking part in maybe another PBM establishing one, which we're in conversations with, but then the third largest is still remaining as a traditional PBM. So once those private payers go with one, the others open up because we haven't seen overlap across. So there's still opportunity for us in all the Part D programs that are out there.
Dhaval, does that answer your question?
Yes. Thank you. That, that's all from my side.
Thank you, Dhaval. Ladies and gentlemen, that was the last question for the day. I thank you all for joining today's investor call, and if there are any subsequent questions or clarification needed, please do get in touch with us. With that, have a good day, and goodbye.