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Thank you, Peter. We will wait for the questions to be assemble d. We will take the first question from Damayanti Kerai from HSBC.

So, my first question is on your commercial biosimilars in the U.S. So good pickup seen in all the 3 products, Ogivri, Fulphila and Semglee. So, it appears that upcoming launches will most likely make a meaningful impact a year later from now, whether it is Bevacizumab or Aspart or other biosimilars. So just want to understand in the commercial biosimilars, what kind of further headroom do you see for growth? And how should we see this biosimilar growth trajectory from USD 1 billion mark?

Thank you, Damayanti, for the question. I'll start with my response, but perhaps Shreehas and Matt can add to this. I think, first of all, we're very pleased with the momentum we're seeing only 2 quarters out from taking the business over in the United States, we're seeing some very robust market share increases. These are, of course, driven by volume demand for our products, and they are c oming along with some pressures on pricing, but we see sustained demand in volume for our products, I think, both in the private and the government sectors. And we see that coming across our full range of products in market today. And I would also comment that I think you are right, Damayanti, that I think the new product launches while they could have some impact in this fiscal, the major impact would be seen in fiscal '26. Shreehas, maybe you want to build upon that and Matt probably with some details on the end market demand profile in the United States, in particular.

Yes, sure. Absolutely. Thank you for the question. Look, what we are seeing is really the ability to understand in the U.S, the Part D side, and Part B in our portfolio. And we are building upon this through this relentless focus we have, not only with our sales team, but building those relationships with market access. So, we are building on the foundation and setting ourselves up for a nice portfolio in Oncology, Diabetes and even Immunology as we prepare to launch new products as we go into the latter half of FY'25 and then continue to set us for success in FY'26. Maybe we have Shreehas now, but those are my thoughts there, Peter.

Thank you, Matt. Shreehas, did you want to add anything? I think Shreehas may be struggling with technology. So, Damayanti, does that answer your question?

Yes, it does. My second question is on your progress in first to gain market access and payer coverage for Adalimumab. So, you basically commented the market will Transcript - Biocon Limited Q4 FY24 Earnings Call notably start opening up in calendar year 2025 or maybe bit later. So meanwhile, can just update us on your effort on the payer coverage side.

Sure. And let me start again. I mean I'll repeat that Adalimumab for Biocon Biologics has been a real success story, as you can see from our positions in Europe. We are going to look to build on that experience in the United States. And as I said in my commentary, we don't really see the market opening up in calendar '24, but we'll see it begin to open up more materially in '25 as formularies take the originator of f their lists. And we will be working to establish our foothold as that opens and then build from there towards a stronger position through calendar '25. Matt, again, can comment a little bit more on the channel details and the model on that and our strengths that we are putting to work.

Yes. Thank you, Peter. We are still seeing the foothold of Humira o n most of the formularies. As Peter stated in the opening remarks and just data, too, this will start opening up in 1/1/25. What we've been able to do is secure some positions within our market access team in regard to having not only Humira but having Biosimilars on there. So as the payers start to transition Humira off, we will start using our sales force to start pulling our products through to increase that market share. The other thing I would say is that we have tremendous relationships. As you know, we have been working market access since we launched our products in 2018. So, the payers are very familiar with Biocon. We are aggressively pursuing these opportunities, and we do see some opportunities lifting and will be in position in 1/1/25 to be able to take those advantages in which the payers decide.

We'll take the next question from Jainil Shah from JM Financial.

My first question is on Denosumab. Sandoz has settled with the innovator. And do you believe that we will be in the first wave of launches because we will be filing by the end of this year. So, what are your thoughts on that?

Yes, as I said in my opening remarks, we think we will when we are delighted to have secured that opportunity and are working, as you'd imagine, toward that, very aggressively. And again, this is an opportunity where we can put some of our existing capabilities and strengths to work in that market. And again, perhaps, Matt, you'd like to pick up on that and maybe on the regulatory status as well.

Matt, this is Sandeep. If...

Yes, Sandeep, that would be helpful.

Yes. Certainly, I mean, I can confirm that we are in a good position to make the filings in the next few months. And we will be the first cohorts that can launch in the U.S. and Europe as well.

Our package looks good. The data is looking fine. I think I am very optimistic in terms of going through the approval. It takes a regular cycle of about 12 months for the FDA and about 15 months with the clock stop for EMA. So that will be standard as expected for all the molecules.

Sure. And just one on the CapEx that we are planning for the next 2 to 3 years?

Let me take that. I think that what you will see is that Capex will taper down, calibrate down from recent levels, but we will be maintaining the necessary investments to support the capacities that we are building to underpin both the existing near -term growth opportunities and mid-term opportunities that we are mo ving towards. So, you will see some calibration down, but we are not going to stop investing behind the very substantial near-term mid and longer -term opportunities that we've been building towards over the last few years.

Sure. And just one more, if I may. In the Generics business, what is our growth guidance? And how many launches do we expect next year? We have alluded towards being stronger, but if you can give us some guidance on how many launches are there? How do we expect Vizag to start contributing? So, your thoughts?

Sure. I will ask Sid to provide more detail. But again, I will comment that what we are looking at is transitional acceleration, and we see that picking up in the second half of this fiscal, built on the new product launches, especially in formulations that we have invested in over the last years. And as I said in my commentary, we have made a large number of regulatory submissions. We have had good success and approvals, and we expect to see that momentum continue and that will underpin the gr owth that we'll be looking for in the Generic business over fiscal '25. Sid, do you want to add anything more to that?

I think the only optics, which I would like to give is, of course, this is a combination of products that we have filed in the U.S., which includes a few injectables and few OSD s, which are either approved by the FDA and waiting for launch or they are under final review with the FDA and we will launch during the course of the year. Plus, as we mentioned earlier that Liraglutide in U.K. will be launched by our partner, Zentiva and by us by end of this calendar year. And our file is also in the advanced stages of review with European authorities. And once we receive those approvals, that product could be launched as well in the second half of this fiscal year. So, a combination of the launch of Liraglutide in U.K. and Europe, plus few products in the U.S. will drive that growth. I cannot give you the exact number of products. Our portfolio continues to be limited in terms of total number. But of course, these are differentiated high-value products that we are working on.

We'll take the next question from Surya Patra from Phillip Capital.

My first question is on the Biosimilar business. So having seen strong volume growth in the recent quarters, for the already marketed products. T he like-to-like Transcript - Biocon Limited Q4 FY24 Earnings Call growth in Biosimilars looks either muted or declining for FY'24, versus last year. So given that and the kind of price competition, although there is volume ramp up that is visible. And also likely the ramp-up in the key products in FY'26. So, what growth one should really think of for the Biosimilar portfolio in FY'25?

Surya, I think that there's strong momentum in the in- market products in the biosimilars business. As I have said in my opening remarks, this includes market share gains that are not insubstantial market share gains across all our products in the United States. Robust market share performance in the quarter that we transitioned the business in the United States, leading market shares in many instances in Europe. And the highest ever quarter that we have seen in the Emerging Markets business. So, I think there's positive growth momentum in the Biosimilars business. And we would expect that growth momentum to continue during fiscal '25. Matt’s given some comments on some elements of that. But we have seen extremely robust demand for our products, and that’s reflected in very high-volume pickup in the last 2 quarters of the prior fiscal and we expect that momentum to push through into this fiscal. So, I do not quite see the market starting point, as you’ ve described. But I think we are building off a very encouraging momentum and we’d look to see that push on through. Shreehas, you can put a little bit more color on that?

It’s pretty comprehensive, Peter. I just say, Surya, that if you look at the products that we have brought in the market in the United States, which is a very large market, each of those products now com mand a fifth of the market share, a fourth to a fifth . And I think that is something which will clearly demonstrate that we have got a sizable piece of the opportunity there. In Europe, you are seeing us move from the 2-country approach that we had in the past to the other countries, the other large countries in Europe and Emerging Markets, Peter just talked about the strong response we are seeing from our key emerging markets. The current immediate focus is on the products that are commercial. But if you want to look at how things are shaping up in the near-term future, that will be on the back of new product launches. We talked about 2 in the opening remarks, and we also have the risk -free launches that we're looking at from new products into major geographies. So, I would think it is a very strong expectation in terms of how we are moving things forward. We have good momentum, and we expect to drive this in the years to come.

Sure, sir. The second question is on the, let's say, about Humira to be specific end of the pipeline products, including Ustekinumab. So, starting with Humira. We have seen Humira has seen some kind of revenue decline in the recent quarters, but that has not translated to any kind of improvement in Biosimilars. So, does that mean Humira is losing out business to some competing products and if that is the case, whether Biosimilar opportunity is likely to be shrinking for adalimumab?

Yes. Thanks, Peter. And Surya, that is a very fair question. Just to index this properly, Adalimumab in the U.S. was the first product that in that sense, saw Biosimilars coming up in the -- in what the U.S. market calls as the pharmacy benefit space or the Part D space. And that operates very differently than the previously launched products that we have seen in the oncology space. So, to understand that space a little bit different than how the oncology products, which are more buy -and-bill operate. So, this was, I think, in many ways for all the players, including the payers and the PBMs to understand how this opportunity unravels itself. And I think what we have seen is that everyone's trying to understand how a USD 20 billion asset eventually plays out. And like Peter mentioned in his opening comments, we had always said that '23 is when it may open up, but it will only begin in '24 and some meaningful progress on the Biosimilars will only happen in 2025. And I think we have probably seen that starting to happen in '24, where you're seeing 1 or 2 Biosimilars players starting to get some market share through some innovative models that the PBMs have come up with. And '23 essentially was where the innovator continued to hold more than 98% of the market. Now this is something that was a first experience for everyone in the pharmacy benefit space for such a large asset. Stelara will, of course, play out following this. There will be some learnings of this including things like product attributes, including interchangeability, including our ability to negotiate, all of this will help the industry, the biosimilar players as well as the PBMs to help shape this as we go forward, Surya.

Okay. Sir, just last clarification from my side, sir, in fact about the marketing arrangement what we had with Viatris at the time of acquisition of the Biosimilar business in U.S. Whether -- when we are saying that we have now integrated ourselves. So, wh ether that marketing arrangement is effective for FY'25, that is there or not? And secondly, about R&D spend, the fourth quarter have seen some kind of moderation to around 8% of the revenues, excluding of Syngene. So, whether it is the kind of fair run rate that one should build for next year?

Let me start with that. l will start with the second question first on R&D. As I said in my remarks, Surya, I think you'll see -- as you've identified in Q4, a calibration down from previous levels. But this is in part due to the cyclical nature of where assets sit in our R&D and particularly the development pipeline, it is not a constant spend. It does modulate as you move assets from early stage and into later stage development, which is more expensive. So, there is a natural curve there. But the other comment I want to make is we are going to continue to invest behind building a very globally competitive pipeline of assets. And that has been something that Biocon Biologics committed to many years ago, and it is a theme that we're going to persist with. We are confident about our ability to build a competitive global pipeline that will serve our Transcript - Biocon Limited Q4 FY24 Earnings Call growth aspirations in the mid and the longer term. And as I said also, we now have an exciting and visible flow of new products on the near -term horizon. I'm sorry. Sorry, your first question was...

Marketing arrangement was...

Marketing arrangement, yes. I'm going to ask Shreehas to comment as well. The marketing arrangements with Viatris have now all successfully completed, and the handover is complete. We have no lasting marketing arrangements left in terms of marketing and commercial capability. Obviously, within that transaction with Viatris, we have got some great people that have come over and join Biocon Biologics. And their expertise, their capabilities are helping underpin the exciting growth momentum that we're seeing in these early quarters as we complete the full transaction. But just to be clear, Surya, on this one, there are no marketing arrangements left here. There may be some small peripheral support activities related more to administration, but there is no marketing legacy contractual remains here. This is now fully the Biocon Biologics team driving this momentum.

Okay. Sure. So, will this lead to some absolute increase in either employee cost or any other cost element for us?

I mean the short answer to that is yes, because in the previous collaboration model with Viatris, they had those costs. But of course, they took a lot of the profit as well. So now we have those costs, and you will have seen that reflected in some of last year's numbers. So, we are now carrying the cost of that commercial marketing team and activity. But now we are capturing the full value of those efforts. And it is, as I said, very encouraging to see the market share gains and the momentum building, and we are capturing all the value now in this fully vertically integrated model. Shreehas, do you want to add anything to that?

No, Peter, I think you covered it well. Perfect.

The next question from Neha Manpuria from Bank of America.

Just a follow-up on the Humira -- the biosimilar Humira that we talked about. The 2 private label launches that we've seen by biosimilar companies seem to be gaining good traction, at least that's what the initial data seems to show. So, as we talk about the market opening up in 2025, does that put our ability to then get in and get meaningful share at risk with these existing players probably scaling up over the next few months?

Neha, I think it is a very interesting question. It is one that the team have been looking at for some time, and I think are advancing our own thinking on that, not simply for Humira but beyond. I am going to ask Matt here to comment a little bit more on that and perhaps develop a little bit our thinking there.

Sure. And I will let Shreehas, please chime in as well. So, you are correct. We are seeing the private labels starting to migrate. And the reason is, is that recently, C VS announced Transcript - Biocon Limited Q4 FY24 Earnings Call that they were transitioning from Humira. And remember, as we look at this, we look at a commercial piece, we look at Medicare, Medicaid, there's multiple channels. And also, there's 2 other large commercial entities that are available to play in which we are bidding now for 1/1 start dates. So just as we are seeing these private labels migrate, that does not leave all the market out for Biocon. The market is open in the commercial, in the Medicare and the Medicaid business. So, we are actively set up in pursuing those opportunities, and we are also keeping a close eye and understanding how the private label and how that's switching and the progress there. But we still believe we have an opportunity in which we are currently bidding on for more growth in FY'25 starting in 1/1/25. But anything, Shreehas, you would like to add?

No, perfect Matt. I think this is good.

That's very helpful. And my second question is, Peter, you mentioned in your opening remarks that debt reduction remains a priority for the company. Given that a lot of the launches are going to be back ended with bulk of the benefit in FY'26, how should we think about net debt reduction for BBL and Biocon in the next year? I mean, what avenues are we looking at to reduce debt? Or if you could give any number, that would be great.

Right. So, Neha, let me start by saying that we are -- while debt reduction, as I said in my opening remarks, is a priority. We are comfortable with our ability to service all our obligations. We will be looking to reduce debt. And as you have seen in the last fiscal, we allocated USD 250 million to acquisition -related debt reduction. We have an extensive range of options, and we are going to explore all of them, and we'll look to make the right decision at the right time on that. We have bank opportunities, w e have equity opportunities, we have hybrid opportunities. There are a pretty extensive range of levers that we can look at, and we are exploring, and we will make debt reductions during the course of this year. We will do them, I think, at the right time, and I cannot give any specific quantitative guidance on that. But for sure, you will be updated as and when we become active there.

We will take the next question from Ankush Mahajan from Axis Securities.

So, my question is what's the outlook for the debt on, sir?

Was that question on the outlook on debt?

Yes, sir, outlook on debt.

Okay. Ankush. As I have said, I think the starting point is to understand that we are comfortable in servicing in the debt that we have. But we are also going to be looking to reduce the debt levels. And we have a wide range of options to explore. As I said, we can look at bank options on debt, we can look at equity options, we can look at hybrid options. There are other levers. We are exploring that. We will be looking to reduce debt this year, but I can't give details of when and how much we will be looking to make those decisions Transcript - Biocon Limited Q4 FY24 Earnings Call as appropriate during the year. And of course, we will be updating you as and when we do.

We take the next question from Nitin Agarwal from DAM Capital.

I have two questions on Generics. What are you thinking about the approvals for the U.S. market, which...

I am sorry, I didn't hear that question.

Where are we on the approvals for GLP-1 in the U.S. market was Nitin's question.

Sid, why don't you take that?

Yes. So, the file is under review with the FDA, and we are quite positive that we should hear back from the FDA. Of course, this requires a facility inspection as well because this product was filed from Biocon Biologics Injectable Facility. And as Peter alluded to in his opening comment, we are expecting FDA to inspect the facility in the coming months. And hopefully, when they come to review the facility, inspect the facilities, they will look at it for Liraglutide as well. So, I think Peter also alluded to the fact that we expect L iraglutide to meaningfully start contributing to the growth from FY'26. And even if the approval comes through later part of this year, we will see a meaningful difference coming in from both now Europe and U.S. in FY'26.

And secondly, if you can provide some clarity -- some color on how would the immunosuppressant new facilities scaling up? What kind of capacity utilization do we have? And how do we see that part progressing?

So, the existing capacities, of course, we have done a lot of process optimization to enhance the capacity while we qualify Vizag and again, as you know that we have got the CEP from the European authorities, so we can already start commercializing part of those quantity capacities in Europe. But of course, for us, the bigger market is the U.S. and Latin America, and we are expecting FDA to come in and inspect the facility, after which we will be able to address the demand. Of course, when you look at our current facility and Vizag, we will have a huge opportunity to capture a much larger market share for immunosuppressants at a global level.

And so, with your capacity of the increase scale coming through, do you foresee a situation of increased sort of pricing competition in this space? I mean is the demand there to absorb such a large capacity that you are going to bring on board.

Well, the demand is growing because the volume share is going up. Now of course, there is competitive pressure. Whether it is from rest of the world or India and in some cases, other companies who has their own immunosuppressant fermentation capacities. So, we are also working with a lot of 505(b)(2) s. As you know that we have a large customer, which was based out of U.S., they have their own 505(b)(2). And overall, when we look at the Immunosuppressants market, it is expected to grow. So , we of course, have to participate in the market going up and compete with others on the market share and winning additional business. I think last Transcript - Biocon Limited Q4 FY24 Earnings Call quarter, we also got a very important approval in China for Mycophenolic sodium. And we also have other immunosuppressants, which are under review with the Chinese authorities. And China, as you know, is also a large volume market. So, we would look at geographical expansion. We would look at increasing our wallet share. In our core markets like U.S. and Latin America and overall, the market share is growing up as the number of transplants grow.

Thank you very much for your questions. That was the last question of the day given the timelines we are at. For the question that will remain unanswered, I request the participants to please send us an e-mail, and we will be happy to take them offline. With this, we will conclude today's presentation. I thank every one of you for joining us today and have a great rest of the evening. Good night. -Ends-

The contents of this transcript have been edited to improve accuracy and readability.