Throughline · holding view Deep analysis Q3 FY25
BIOCON Biocon Limited · Pharma Q3 FY25 · concall
Pattern: market share doubling vs

BBL+BL merger and structured-debt arc closed Q3 (Goldman/Kotak/Edelweiss retired).

1 deflection · 4 weak · 17 clean pushback across 5 of 22 Q&A turns

Focused evidence 5 of 22

Shyam Srinivasan · Goldman Sachs India Securitiesweak

Market shares have doubled but revenue in dollar terms is only growing 10%. Is there price erosion? What's the trajectory for next 12-18 months?

Part of it, I did respond when I was responding to Damayanti at the beginning. These market shares have grown significantly across geographies. And if you would note, they have come at a steady, healthy contribution to the bottom line. The EBITDA margins have stayed consistent. The market share growth reflects the volume growth. not every product will retain the value that it has a year ago. We have, obviously, in any market, when you have competition, you will see a steady erosion, but it is not something that has been unexpected or unplanned that has impacted the gross margins. The price erosion is in line with what we had budgeted for.

Love Sharma · JP Morgan Securitiesweak

What other liquidity options do investors in BBL have? Is an IPO still required given the recent bridging loan?

We have a number of investors. We are working with all of them. We are looking to align their interest and satisfy them. And IPO clearly is one of the options that we have to do that. I think it would be inappropriate to go into details individually here, but I think it would be fair to say that we are working with all those investors to ensure that we align to satisfy them as the business is progressing. And I think we're making good progress on that front.

Vivek Agrawal · Citi Investment Researchweak

Is 22-23% EBITDA margin guidance conservative given upcoming new launches?

I like the optimism, Vivek, and I accept the positive feedback. We certainly have a lot of things moving in the right direction. The year ahead, we have 5 new launches coming up in the U.S. and 3 globally. So certainly, whenever you have a new product launch, you will see a slightly better-than-expected performance. So yes, your expectation is fair. But we also see that some of our products have been in the market for a while. We want to make sure that we have always said that we will continue to invest about 7% to 9% in R&D. We will have healthy strong gross margins and core EBITDAs in the mid-30s, which is where we are. And the EBITDA would be in the mid-20s, so some 22%, 23%, maybe 25%.

Vivek Agrawal · Citi Investment Researchdeflection

In which specific markets are you expecting Semaglutide approvals in 2026?

it will be very difficult to comment on which might the approval comes in. Each regulator has a different lens on how they will review a drug filing and also depends on a number of approvals in that country for Semaglutide. if the number of approvals is less, then they will fast track the review. We do expect Canada to be an important market. The Canadian regulator has been proactive in reviewing the files, unlike maybe a Brazilian regulator or a Mexican regulator who might take a little longer. the broad message is the drug has completed its development journey. We have got the scientific data. It meets the requirement. API DMF has been filed. The products the product has been manufactured, charged on stability, the dossier is under preparation, and we'll start filing in various markets this year.

Bharat Sheth · Quest Investment Advisorsweak

Can you give a ballpark on BBL biosimilar business longer-term trajectory given the 75% CAGR opportunity cited?

The opportunity ahead of us for biosimilars is much larger than the one that we've seen in the past 5 or 6 years. We are also looking at the portfolio that we have developed. We have a large 20 product portfolio. 8 of them are approved or commercial, and we are looking to bring more products into the market. But these products, 5 of them in the U.S. in the next 12 months, 3 of them globally. And then you will see more products coming post 2028 and thereabouts. We believe the future will also be predictably positive as we look to bring more products into the market.

Other Q&A (17)
Damayanti Kerai · HSBC Securities and Capital Markets

On Stelara biosimilar: what kind of market uptake are you expecting given it's a Part D product and potential Humira-like dynamics?

As you can imagine, we are very excited about the upcoming launch for biosimilar, Ustekinumab. We will be amongst that wave of products that will be coming to the United States. But I also want to draw your attention that this is a global launch. So, we will be looking to bring this product to Europe as well. There is a huge opportunity that we are looking forward to. I do acknowledge what you said about the Part D and the past that has been the case with the biosimilar Adalimumab. obviously, we are very conscious of that. Our teams are working very hard with customers, both commercial as well as the government customers as well. We believe we will be very competitive in this space, both for Ustekinumab and even as we progress the Adalimumab asset as we go forward. So very exciting times for us as we get into a global launch for a very large asset.

Damayanti Kerai · HSBC Securities and Capital Markets

Market share gains don't seem to be matching profitability improvement. Is growth coming from low-margin channels?

I wouldn't say that it's a low-margin business or we have probably seen growth only in terms of the low profitability channels. We have 2 products in the oncology space that operate in the Part B or the medical benefit space. And we have seen significant growth there in terms of how our products have performed both for Pegfilgrastim, which have seen a huge improvement from low double digits to actually mid-20s, which is a substantial shift. And that's come very profitably. So, it's not coming through the lower-margin channels. Likewise, with Trastuzumab as well. The margins for the Biocon Biologics business have been quite healthy. And we continue to invest in R&D in that 6%, 7% to 9% range that we have guided. So that's been also quite healthy. And we continue to have an EBITDA margin of 22% to 23%.

Damayanti Kerai · HSBC Securities and Capital Markets

Model adjustment: about 150 bps overhead charge on BBL inventory for the quarter?

I think, for the quarter, you should model about 150 basis points of revenue as overhead charge on the inventory. So that's a timing in nature. We'll recover it in quarter 4. As we adjusted inventory, I think the overhead hits the gross margin line. So that's the adjustment and modelling you need to do.

Neha Manpuria · BofA Securities India

Biocon buying 1.5% stake in BBL via short-term bridging loan — what's the fully diluted holding after this and current net debt?

We will get closer to 72% after the acquisition. Syngene is USD 100 million net cash positive. In Generics we have roughly similar amount of net debt. And at Biocon Biologics, that's roughly USD 1.25 billion. This is now in December. So, you will add another USD 65 million of the commercial paper, so that will get you to USD 1.3 billion.

Neha Manpuria · BofA Securities India

When does Generics return to mid-teen growth? Liraglutide UK launch timing?

As you have seen in this quarter, we have had a 10% sequential growth, and a large part of that growth has come from increase in API business, so very little contribution from peptides yet during the third quarter. And as Peter mentioned in his opening remarks, Liraglutide would be launched in the U.K. in the fourth quarter. We have already shipped the material to our testing site in Europe. The product is getting tested and will get released and launched by a partner and us in the fourth quarter. Post the national approval of Liraglutide in Europe, we are doing national registries in each country, and we expect that launch to happen in the first quarter of next fiscal. Yes. Fiscal 2026 itself you will start seeing this growth.

Neha Manpuria · BofA Securities India

Now that Malaysia facility is cleared, what's pending for Bevacizumab and Aspart US approvals?

The only thing that it really which was open, there was no open question on the science or the dossier, both for Bevacizumab or for Aspart that and the agency had indicated that. The only piece that was remaining was the site GMP status. With that achieved, we have responded to them saying that we have now completed this. And we want them to reconsider our application at the earliest. So that is the process that is ongoing. And our regulatory team is in conversation with them to see how we can move this in an expedited manner.

Shyam Srinivasan · Goldman Sachs India Securities

On capital allocation — you're buying BBL stake but also selling Syngene. Will Syngene go below 50%? What's the plan for debt reduction?

It is a balancing act over time. We have had a series of obligations that we had to meet, and we've been meeting them properly, obviously, the Viatris full and final settlement on the acquisition, we have spoken about. We have had other financial obligations, which we have met. That is been balanced with the investment in the business to prepare for this next wave of growth. We will continue to balance meeting the obligations that we have as and when they may come due as we have done very recently. That's a short-term measure of a bridging loan. But we are committed to and will continue to look to pay down debt as we move forward. In regard to the specific question about the holding in Syngene, I think we're down now to around 52%. And I think we would like to keep it there, and we'll be exploring other options going forward.

Amey Chalke · JM Financial Institutional Securities

What is Biocon's status on Semaglutide given approaching patent expiries in Canada, Brazil, China, India?

The development is going well. We have already filed our DMF in the U.S. It is already listed on the FDA website. We have done the drug product development batches and charged it on stability. We have also completed India bioequivalence study, which is important for filing in many markets because certain markets require bioequivalence and that successfully passed. From a scientific perspective, the file is ready to file, and we will be looking at filing it in the markets. Some of the markets that you mentioned in first quarter of next fiscal, and of course, the review cycle varies in each of these countries. And depending on the approval, we will be looking at entering, may not be on day 1, but may not be too far from the other competitors who might launch the product on day 1. My expectation is that we should start receiving approvals in some of these markets by end of calendar 2026.

Amey Chalke · JM Financial Institutional Securities

Insulin plant expansion — where does it stand and how much capacity addition?

The insulin, overall, is a very important product for us. And I think it is a very strategic play globally for us. There is no real biosimilar competition that we see for insulins across geographies. We made investments over the years and the most recent investment that you are referring to has doubled our capacity for drug product, which is expected to come online any time end of this quarter. So that is something that we expect to significantly boost our capacity for drug product manufacturing. We are also expanding our insulin drug substance, which we had guided in the past, and that's underway. Once that's completed, we expect to see a doubling of that drug substance capacity in Malaysia as well. So that will take us another couple of years to do, but that's something that we had started about a year ago. And it's important to note that Biocon Biologics is amongst the top 3, 4 players of the insulins in the world.

Love Sharma · JP Morgan Securities

What was the Viatris full and final settlement amount in December quarter?

The Viatris settlement, Love, was about the deferred payment that we had to work on. And like we have said, we have been able to close out the entire USD 335 million, USD 175 million of that we had closed previously, which we had indicated and now we have closed the remaining USD 160 million. So, with this now, there is a full and final settlement and closure of all transaction that was related to the Viatris acquisition.

Surya Patra · Phillip Capital

How prepared are you for Ustekinumab launch and when is Denosumab expected in US?

We are well underway in our launch planning with our customized with our customers in regard to the channel strategies we have in Part D. We are leveraging the existing relationships we have, and we will be driving the synergies that we have in the United States already established. I think what's clearly different, that's probably on a lot of people's minds is, how is this different than Adali? and how it's different than Adali is we've had plenty of time now to engage and also communicate to customers. Adali had a legal kind of hold where we couldn't speak to them because of all the settlements. The other thing that's different is that there's no w a track record in this immunology piece in which players are more comfortable. And last thing I'll say here is that because of our active engagement, because of our sales force, we have already secured some important contracts that are part of our plan, and we look to continue to expand upon that as it gets closer and closer to our launch date.

Surya Patra · Phillip Capital

What's the significance of China Tacrolimus approval and Cranbury US facility qualification for Generics?

China is a very difficult market where Indian companies have not been able to successfully penetrate in a large number of drugs. But Tacrolimus is an important drug for us and is an important drug in China. It is still a large value market in China with a very limited number of local players. Our partner CMS is getting ready to launch the drug in the retail market. In terms of U.S., Cranbury site was acquired because most of these drugs were manufactured at contract manufacturers in various parts of the world, we wanted to consolidate that and be closer to our customers and the facility allows us to participate in the local government business, which requires manufacturing in the U.S. So, we have got 3 approvals from that facility. We are also expanding the capacity of that facility, which will be ready by the middle of this calendar year.

Nitin Agarwal · DAM Capital Advisors

What's the geographic revenue split for BBL — North America, Europe, Emerging Markets?

If you look at it roughly, our business is between advanced markets and emerging markets about 75%-25%. And between the advanced markets, if I were to take a split between North America and Europe, Japan, Australia, you roughly see it biased slightly towards the U.S., maybe 40%-35% is what it would be between North America and the rest of advanced markets. So that's the rough split, I would say, 40%-35%-25%. That is how the split would be between these 3 regions.

Nitin Agarwal · DAM Capital Advisors

With GLP-1 companies focusing elsewhere, are you seeing reduced insulin competition from innovators? What's the 3-5 year view?

insulins are here to stay regardless of how the GLP-1 agonist strategy plays out because that is certainly an important therapy area in the segment, and we are very bullish about the GLP-1 segment as well. We are seeing a continued demand. We are seeing an increased focus on this. Globally, there is a requirement for this product, which continues to be there. You're right, they are out of the 3 large companies which were making insulins, 2 of them have GLP-1s in their portfolio and clearly more remunerative in their mind probably in the near term. The focus and attention could be, like you said, being in another place. But we are very focused on both. And Biocon Biologics is very focused on insulins. And given our full integration from drug substance, drug product to devices, we are seeing an increase in the opportunity, particularly in emerging markets and then the United States as well.

Bharat Sheth · Quest Investment Advisors

How does Biocon standalone Generics look from a 3-year perspective on growth and margins?

I had addressed a previous question where I had reaffirmed that we are looking at the mid-teen kind of growth. There could be periods when it's higher, there could be periods when it's lower. But overall, directionally, I think peptides is going to be an important growth contributor over the next couple of years, starting with Liraglutide in FY 2026 and start of Semaglutide in FY 2027. And in FY 2028, we will see a significant contribution coming from both Lira, Sema and even on the synthetic side, whether it's OSDs or the other injectables that we have or the increased capacities that we are creating for our fermentation products or the synthetic products. So, sum total of all, we definitely expect a good growth over the next 2 to 3 years. For margins: directionally, what I have guided for is an EBITDA margin of 10% to 12%. We will get closer to 13%, 14% in 1 or 2 years.

Alankar Garude · Kotak Securities

R&D at lower end of 7-9% range for last few quarters — what's the pre-filing pipeline and R&D outlook?

Many of these R&D spends, Alankar, as you know, are cyclical in nature. So, as you take products past the clinical stage, then you will see a slightly lower spend in our investment in R&D, then you would see when products are in the clinical phase. Now, incidentally, for us, we had 3 products which were in the clinic at the same time, and which moved out of it also at the same time. What you are seeing effectively we filed for Aflibercept, we moved that out. We filed for Ustekinumab, that got approved. We have done Denosumab and that's got approved, too. You have seen products which would have then peaked at one time and then it's ebbed. And you see the next set of products, which we are developing, some of them undisclosed until we actually move past that stage.

Alankar Garude · Kotak Securities

What is the Vizag facility utilization and customer pipeline?

It will be used for our API customers as well as our captive consumption. Our API customer base is much larger than our own formulations business. We have some very strategic customers in the U.S. and Brazil who are qualifying Vizag as well. And that is also to derisk their own dependency on 1 site, which is in Bengaluru. So that gives them a supply assurance from a second site. And we are also locking in additional customers from Vizag and that will drive the volume growth. No. I mean I think in the initial years, it will be low. We are looking at what's the best way of increasing the utilization from this facility.

Prepared remarks (4 blocks)
Thank you, Saurabh, and good morning, everybody. Before presenting the results in detail, I would like to start with some high-level remarks. The third quarter of fiscal 2025 has been both important and progressive across the group companies, reflecting continued executional delivery as well as strategic strengthening in our regulatory, operational, and financial platforms that will underpin our short, medium, and long-term growth objectives. Highlights include successful outcomes in 4 separate FDA audits across 3 sites in Biocon Biologics and Biocon, key product approvals in both our Biologics and Generics businesses with launches commencing in Q4 this fiscal, and completion of all BBLs deferred milestones under the acquisition agreement with Viatris, marking the full and final remittance of considerations towards the acquisition. The overall group financial performance for the quarter was in line with our expectations and led by year-on-year operating revenue growth of 10% on a like-for-like basis after adjusting for revenues and a divestment gain from the India Branded Formulations unit in Q3 FY24. Performance for the quarter was driven by sustained growth in Biosimilars and a return to growth in Research Services with both verticals reporting healthy double-digit growth rates. Generics recorded a marginal year-on-year decline. On a sequential basis, all 3 verticals delivered growth. With performance delivery in line with our expectations and with the strengthening of building blocks for future growth across our businesses, we maintain our outlook for a transition to growth in the second half of this year and into next fiscal with improved visibility across all businesses. Syngene has returned to growth this quarter and is on the right trajectory for the rest of the financial year. Biosimilars has maintained its good growth momentum and now has a clear line of sight for new and important product launches, while recovery in the Generics business will be driven by the launch of our first GLP generic in the U.K.
and EU, coupled with new launches in the United States. Revenue from operations was INR <strong>3,821 crore</strong>, up 10% year-on-year and up 6% sequentially on a like-for-like basis. Group core EBITDA for the quarter stood at INR 1,007 crore, up 4% from last year and with a healthy core operating margin of 26%. Quarterly R&D investment spend stood at INR 199 crore, corresponding to 7% of revenues excluding Syngene. Reported EBITDA for the quarter stood at INR 787 crore with a margin of 20%. Profit before tax and exceptional items was INR 138 crore, improving on a like-for-like basis from a loss last year. Reported Net Profit is INR 25 crore. Revenue from operations was INR 686 crores, growing a healthy 10% on a sequential basis while showing a marginal decline of 2% year-on-year. Core EBITDA for the quarter was INR 102 crore with a margin of 15%. Notable milestone was DCP approval for generic GLP Liraglutide in the European Union for both diabetes and obesity indications. Also, U.S. FDA inspections of Bengaluru API sites received Establishment Inspection Reports with Voluntary Action Indicated classification. On Biosimilars: Biosimilars Revenue from operations was INR 2,289 crore, up a healthy 14% year-on-year on a like-to-like basis. Sequentially, revenue grew 5%. EBITDA for the quarter was INR 487 crore. Excluding the Forex impact, the EBITDA margin stood at 22%. The U.S. FDA has classified our multiproduct Biocon Park facilities in Bengaluru, India, and our insulins facilities in Johor in Malaysia, as VAI, or Voluntary Action Initiated. We also received U.S. FDA approval for Yesintek, biosimilar Ustekinumab, and are preparing for February 2025 launch. Market share for Ogivri doubled to 22% from 11% last year, while Fulphila rose to 23% from 19% last year. On Research Services: Syngene revenue from operations INR 944 crores, up 11% on a year-on-year basis and up 6% sequentially. Reported EBITDA at INR 302 crore was up 16% year-on-year. The reported EBITDA margin improved to over 31% from 29.5% in the comparable quarter last year. We maintain our outlook for a transition of growth in the remainder of this year and into next fiscal.
Revenue from operations was INR <strong>3,821 crore</strong>, up 10% year-on-year and up 6% sequentially on a like-for-like basis. The like-for-like basis excludes revenues, and a divestment gain from the India Branded Formulations unit in Q3 FY24. As mentioned in my opening, this top line performance reflects the balance of performance at the segment level where, on a year-on-year basis, Biosimilars revenues from operations grew 14%, Research Services grew 11%, and Generics saw a marginal decline of 2%. On a sequential basis, all segments reported operating revenue growth with Generics growing by 10%, Research Services by 6% and Biosimilars 5%. Total group revenue for Q3 FY25 was INR 3,856 crore, a growth of 7% last year and 6% sequentially on a like for like basis when excluding revenues and a divestment gain from the India Branded Formulations unit and also a gain from Biocon's stake dilution/ fair valuation of its holding in Bicara Therapeutics, in Q3 FY24. Group core EBITDA for the quarter stood at INR 1,007 crore, up 4% from last year and with a healthy core operating margin of 26%. Quarterly R&D investment spend stood at INR 199 crore, corresponding to 7% of revenues excluding Syngene. Reported EBITDA for the quarter stood at INR 787 crore with a margin of 20%. This represents a growth of 16% on a like-for-like basis. Profit before tax and exceptional items was INR 138 crore, improving on a like-for-like basis from a loss last year. Reported Net Profit is INR 25 crore.
Adjusting for exceptional items, Net Profit for the quarter stood at INR <strong>13 crore</strong>s. Generics Revenue from operations was INR 686 crores, growing a healthy 10% on a sequential basis while showing a marginal decline of 2% year-on-year. Core EBITDA for the quarter was INR 102 crore with a margin of 15%. R&D spend at INR 73 crore and representing 11% of segment revenues. Biosimilars Revenue from operations was INR 2,289 crore, up a healthy 14% year-on-year on a like-to-like basis. Sequentially, revenue grew 5%. EBITDA for the quarter was INR 487 crore, and this includes a non-cash Forex translation loss of INR 20 crores. Excluding the Forex impact, the EBITDA margin stood at 22%. On a like-for-like growth basis, EBITDA grew 44% compared to last year. Syngene revenue from operations INR 944 crores, up 11% on a year-on-year basis and up 6% sequentially. Reported EBITDA at INR 302 crore was up 16% on a year-on-year basis and 16% also sequentially. The reported EBITDA margin improved to over 31% from 29.5% in the comparable quarter last year and 28.8% in Q2 this year. Profit before tax was up 27% from last year and 32% sequentially to INR 181 crore.
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