Right. We have about 200 people in the call now. We will get the call started. Good morning, everyone. I'm Aishwarya Seetharam from the Biocon investor relations team. I would like to welcome you to Biocon's earnings call for Q4 and full year FY 2022. I would like to indicate that all the participants will be in a listen-only mode, and there'll be an opportunity for you to ask questions after the opening remarks conclude. Should you need to raise questions, please select the Raise Hand option under the Reactions tab of your Zoom application. We will call out your name and unmute your line to enable you to ask the question. While asking, please begin with your name and your organization.
Please note that we will not be monitoring any questions on the chat box, but you can raise any technical concerns that you may be facing for our support team to help. I would also like to bring to your attention that this conference is being recorded, and the recording will be available on our website within a day. The transcript for this call will be available within the next five working days. To discuss the company's business performance and outlook, we have with us today the Biocon leadership team comprising of Dr. Kiran Mazumdar-Shaw, our Executive Chairperson, and other senior management colleagues. I'd also like to take this opportunity to remind everyone about safe harbor. Today's discussion may be forward-looking in nature based on the management's current beliefs and expectations.
It must be viewed in concurrence with 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 do get in touch with Nikunj or me. I would now like to turn the call over to Dr. Kiran Mazumdar-Shaw. Over to you, ma'am.
Thank you, Aishwarya. Good morning, everyone. I welcome you to Biocon's earnings call for the fourth quarter and the full year fiscal FY 2022. I would like to start this earnings call on a note of optimism on the back of a strong performance in the year that has just concluded. Biocon reported revenues of INR 8,397 crores or $1.1 billion this fiscal. This year, Biocon has entered into a transformative acquisition with its long-term partner, Viatris, to acquire its biosimilars business portfolio for $3.335 billion. This is in order to create a vertically integrated structure that will ensure an efficient supply chain with embedded agility and competitiveness. We believe that this deal will enhance Biocon's position as a true biosimilar powerhouse.
At Biocon, our key priorities of patient centricity and access to all drive our decisions and the way we operate. ESG has now further assumed a greater prominence in our business objectives. Recognizing our sustainability practices, EcoVadis, a global sustainability rating agency, placed Biocon in the bronze category with an overall score of 52 as against 35 in the previous year. Let me emphasize the fact that our pipeline or our research pipeline is our lifeline. We continue to invest significantly in research and development to drive long-term business growth. Towards this objective, we invested over INR 700 crores in R&D this fiscal to advance our development programs in the biosimilars and generics area. During this quarter, two of our wave two biosimilar molecules, denosumab and ustekinumab, moved into the clinic.
We also continue to build a strong pipeline of niche formulations such as injectables as well as peptide and potent APIs in our genetics business. We believe these investments will help us further our pursuit in providing high quality and affordable healthcare accessible to all while we drive further value creation. Next slide. Let me now turn to the board update. Before I discuss the performance of the business, I would like to share a board update. I'm pleased to welcome Naina Lal Kidwai, a veteran banker and a business leader, as an additional director on the board of Biocon Limited. An MBA from Harvard Business School, she's a recipient of several awards and honors, including the Padma Shri for her contribution to trade and industry. She's a past president of FICCI.
She retired in 2015 as chairman of HSBC India and executive director of HSBC Asia Pacific. We look forward to Naina's leadership, which we believe will provide a strong impetus to our great growth journey. I will now present the key financial highlights, starting with the quarter and followed by the full year. At a consolidated group level, revenues for Q4 FY22 grew 21% year-on-year and 11% sequentially to INR 2,476 crores. Revenues from our biosimilars business delivered a strong year-on-year growth of 48%, while that of our generics business grew at a healthy rate of 26% and research services revenue grew by 15%. Our gross R&D spend was at INR 232 crores, an increase of 70% over last fiscal, corresponding to 14% of revenue ex-Syngene.
Of this, INR 191 crores is expensed in the P&L, while the rest has been capitalized. Core EBITDA margin, which is EBITDA margin net of licensing, dilution gain on account of our startup, Bicara, mark-to-market loss, Forex, and R&D was higher at 33% compared to 32% in the same quarter last year on account of an improved performance in both biosimilars and generics. EBITDA for the quarter was INR 659 crores, reflecting a 3% year-on-year growth. The EBITDA margins stood at 27% as against 31% reported in Q4 last fiscal, primarily due to, as explained earlier, the higher R&D spends in biosimilars and generics during the quarter. Exceptional items for the quarter included professional fees towards the Viatris deal.
Profit before tax and exceptional items for the quarter stood at INR 384 crores, up 9% over INR 353 crores during the same quarter last fiscal. Net profit for exceptional items for the quarter stood at INR 262 crores versus INR 247 crores versus INR 257 crores last fiscal. Net profit, adjusting for exceptional items, stood at INR 239 crores. Adjusting for the mark-to-market loss on investments and gain on dilution in Bicara on a like-to-like basis, growth and margins are higher compared to the same period in the previous fiscal. Which translates to 37% growth in core EBITDA versus reported growth of 11%, 32% growth in EBITDA versus reported growth of 3%, 75% growth in profit before tax and exceptional items versus reported growth of 9% with a 5% higher margin.
176% growth in net profit before exceptional items versus reported growth of -6% and a 5% higher margin. Let me now turn to the full-year financial highlights. At a consolidated group level, revenues for FY 2022 were INR 8,397 crores versus INR 7,398 crores, a year-on-year growth of 14%. Adjusted for the gain from dilution in our Bicara stake, the overall revenues grew by 16%. Revenues from our biosimilars business delivered a strong year-on-year growth of 24%, and our research services, as mentioned, grew at a healthy rate of 19%, while revenues for our generic business remained flat. We recorded a Forex gain of INR 58 crores this fiscal. A loss of INR 28 crores arising on account of mark-to-market loss on investments is also reported this year.
For this fiscal, we also recorded a gross R&D spend of INR 711 crores, which is 13% higher over last fiscal and corresponds to 13% of revenue ex-Syngene. Of this, INR 595 crores is expensed in the P&L, while the balance has been capitalized. Core EBITDA margin, as explained earlier, stood at 32% compared to 31% last year on account of an improved performance by biosimilars. EBITDA for the fiscal was INR 2,183 crores, reflecting a 14% year-on-year growth with a consistent EBITDA margin of 26%. Exceptional items for the year included provisions for export incentives, impact on modification of terms of certain debt instruments, and professional fees towards the Viatris deal. Profit before tax and exceptional items for the year stood at INR 1,094 crores, up 4% over INR 1,055 crores last fiscal.
Net profit before exceptional items stood at INR 722 crore versus INR 744 crore, while net profit for the year after exceptional items stood at INR 648 crore versus the INR 740 crore reported in FY 2021. However, as explained earlier, on a like-to-like adjustment, EBITDA growth was 25% versus the reported growth of 14%, and the growth in core EBITDA was 18% versus 10%. Let me now turn to segmental business performance during the quarter and for the full year. Let me start with generics. The generics segment delivered revenues of INR 717 crore during the quarter, a year-on-year growth of 26%, and a sequential growth of 18%. Profit before tax for the quarter was at INR 116 crore, versus INR 73 crore last year and INR 67 crore in the previous quarter.
Profit before tax margins were higher at 16% as against 13% last fiscal and 11% in the previous quarter. The improved business performance in Q4 was driven by key factors, namely a ramp-up in API sales, new drug product launches in the U.S., particularly everolimus, and the normalization of operational challenges that we have faced earlier in the year. On a full year basis, the generics segment delivered revenues of INR 2,341 crores compared to INR 2,363 crores in the previous fiscal. Profit before tax stood at INR 261 crores versus INR 291 crores the previous fiscal. The segment witnessed a muted performance given the COVID-led operational and supply challenges at the start of the fiscal, which started returning to normalcy in the second half of this fiscal.
However, profitability continued to be impacted by higher logistics and input costs, particularly raw materials, solvents and fuel. Pricing pressure headwinds in several markets further added to this impact. During the quarter, approvals were received from the U.S. FDA for posaconazole, an antifungal drug, as well as dorzolamide, an ophthalmic product, which were also recently launched in Q4. We continued to expand in emerging markets and commenced our first commercial supplies of tacrolimus capsules to Mexico. We also received our first approval in Singapore for tacrolimus and in the UAE for resita, rosuvastatin and tacrolimus. In January this year, we also had a successful regulatory site inspection at our API manufacturing unit located in Biocon Park, Bengaluru, by Health Canada. We are on track to qualify and validate our greenfield fermentation-based immunosuppressants API manufacturing facility in Visakhapatnam.
We also plan to augment our existing API manufacturing infrastructure in Hyderabad and Bengaluru, as well as set up a new injectable facility in Bengaluru. As part of our sustainability focus, we have diversified our renewable power consumption to include both solar and wind energy. We are confident to grow our generics business in FY 2023, supported by new product launches and our expanded manufacturing capacities. While we continue to be resilient, we are cognizant of potential headwinds such as pricing pressure and rising input costs, and we will continue to focus on building costs and operational efficiencies to sustain growth. Now, coming to biosimilars. Biocon Biologics recorded revenues of INR 982 crore for Q4, a year-on-year growth of 48%. Core EBITDA excluding R&D, Forex, licensing income and mark-to-market loss on investments stood at INR 382 crore, up 78% year-on-year.
Core EBITDA margins increased from 33% in Q4 last fiscal to 39% this quarter, demonstrating continued healthy profitability. EBITDA for the quarter was up 56% year-on-year at INR 257 crores, and profit before tax and exceptional items stood at INR 144 crores, up 109% year-on-year. I'm also pleased to say that our Malaysia operations became profitable for the first time this quarter. Moving on to full year performance. Biocon Biologics recorded revenues of INR 3,464 crores in FY 2022, a year-on-year growth of 24%. This rate of growth is much faster than the 21% witnessed in FY 2021, and this, I might add, is in line with our guidance. We witnessed significant improvement in profitability at all levels this year.
Core EBITDA for the year was at INR 1,320 crores, up 30%. Net R&D spends for the year was at 9% of revenue, in line with FY 2021. EBITDA for the year stood at INR 1,013 crores, a year-on-year growth of 35%. Profit before tax and exceptional items has grown by 49% year-on-year, and the growth in profits is attributable to higher revenues and improved margins. Let me now share some highlights of the biosimilars business. The most significant growth driver has been our 351(k) interchangeable biosimilar insulin Glargine in the U.S. market, which has attained a double-digit market share at the end of this quarter.
Biocon expects to end calendar year 2022 with mid- to high-teens in terms of market share. Ogivri's market share in the U.S. reported consistent improvement during the year, attaining double-digit. Fulphila U.S. market share was resilient despite a highly competitive market. In Europe, both these products continued to witness gradual improvement in performance. Abevmy, our biosimilar bevacizumab, was launched in select European markets during the year, further bolstering our oncology franchise. Continued improvement in the performance of our existing products, coupled with potential U.S. launches of biosimilar aspart, Bevacizumab and Adalimumab, will enable the current Viatris-led business to deliver robust growth over the next two years. Our economic interest in Viatris collaboration products will significantly increase once we consummate the deal with Viatris. We have seen impressive growth in our B2B and BFI business.
We've recently been awarded a three-year contract for Insugen in Malaysia, valued at approximately $90 million. We expect our B2B business to be bolstered by the integration of the Viatris transaction, allowing us to target a larger segment of emerging markets. The Branded Formulations India business recorded a year-on-year growth of 35%. We expect that the continued focus on sales force excellence, brand building and KOL engagement will generate sustainable growth for the business. Moving on to pipeline updates. We have advanced two unpartnered wave two biosimilar molecules into the clinic, namely denosumab and ustekinumab. We have exercised the option to acquire Viatris' rights in its biosimilar aflibercept as a part of the transaction. Viatris filed the first biosimilar of aflibercept in the US. Our portfolio of next wave of biosimilars will address the market opportunity of approximately $20 billion to drive growth in the medium term.
The Viatris and Serum deals are progressing towards regulatory approvals. We expect deal closure in the second half of the calendar year 2022. In summary, Biocon Biologics has delivered strong revenue and profit growth this fiscal. Combining the Viatris biosimilar business with BBL accelerates the build-out of our commercial capabilities in developed markets in order to become a strong global brand. Vertical integration will drive operational efficiencies and business agility, thereby underpinning cost competitiveness. The Vaccines alliance with Serum and our continued investment in R&D, adding products to our portfolio, opens up new growth avenues for Biocon Biologics in the coming years. A brief note now on novel. Equillium, our partner, initiated a pivotal phase III clinical trial of itolizumab in patients with acute graft versus host disease, or GvHD, in March this year.
The randomized double-blinded study will assess the efficacy and safety of itolizumab versus placebo as a first-line therapy for acute GvHD in combination with corticosteroids. Our Boston-based associate, Bicara, initiated dose expansion cohorts evaluating its lead molecule, BCA-101, in patients with head and neck squamous cell carcinoma, squamous cell carcinoma of the anal canal and cutaneous squamous cell carcinoma. In February 2022, Bicara has secured the first round of seed funding from external investors to support the clinical development of BCA-101 and other pipeline assets. Coming to research services, revenue from operations stood at INR 758 crores for the quarter, indicating a year-on-year growth of 15%. Profit before tax for the quarter was at INR 179 crores against INR 158 crores in Q4 previous fiscal, which is a growth of 14% year- on- year.
For the full year, revenue from operations stood at INR 2,604 crores, indicating a year-on-year growth of 19%. Profit before tax for the quarter increased by 19%. For the year, increased by 19% year on year to INR 515 crores. The fourth quarter growth was also driven by performance across all divisions. Development services, and particularly a strong quarter as it caught up on the projects delayed due to supply chain issues and other COVID-related disruptions. Phase III of the expansion plan at the Hyderabad research facility was completed during the quarter and the facility now accommodates around 500 scientists. Further expansion is being planned in the year ahead.
Let me now conclude by saying that as we come out of the pandemic with a strong performance, I would like to announce that the board of directors have recommended for approval by the shareholders a final dividend of 10% of face value of each share for the financial year 2022. I would like to conclude by saying that the year ahead holds tremendous promise for all our business segments. The most significant growth is expected to come from the acquisition of Viatris's biosimilars business as well as through the vaccine alliance with Serum. With this, I would like to open it up for Q&A.
Thank you, ma'am. Should you need to ask a question, please select the Raise Hand option under the Action tab of your Zoom application. We will call out your name and unmute your line to ask the question. The first question is from Damayanti Kerai from HSBC.
Hi. Good morning. I hope I'm audible.
Yeah. Yes.
Ma'am, my first question is on biosimilars. We have seen good pickup in prescription volume in most of the launched product. When we look at the sales, reported sales for fourth quarter, sequentially, it's looking flat despite having full quarter benefit of Semglee. Can we have some clarity there, whether it's due to more squeeze on the pricing? How is the pricing environment for most of the launched products, especially insulin Glargine?
Let me start by saying that the insulin Glargine business is showing a strong pickup, like you mentioned. As it has already been reported from a you know 3% market share in the earlier part of the year, we are now registering double digit market share in by the end of this fourth quarter. Yes, I think there has been you know almost like a flat performance of biosimilars in Q3 and Q4. You must understand that this is more reflection of the kind of market improvement of the business. Q1 tends to be a slightly sort of lower quarter in terms of being able to pull out growth as such.
Regardless of that, I would like to mention that our biosimilars business is tracking in the right direction. We have not seen a greater growth because of certain, you know, tenders which open up later in the year. Like for example, we just won that tender from Malaysia, which obviously will start only reflecting in our numbers in the year ahead. I would like perhaps my colleague Shreehas to add to what I've said.
Thanks, Kiran. I think, Damayanti, you had two questions. One is to see, you know, why those numbers have been more or less flattish. A concern if this was anything to do with pricing pressure in the U.S. I think. Let me lay to rest the first part of it, the part related to pricing. We do not see the pricing pressure at all on this aspect. We've got a formulary listing through Viatris, and that's something that we see staying consistent through the course of the year. That's really, you know, quite a set piece there.
I think the aspect related to the flattish numbers that you talked about, let me draw your attention to the earlier part of the fiscal where we had a run rate of about INR 750 crore-INR 800 crore in the early part of the year as our revenues for the quarter, which we broke through in Q3 in that INR 950 crore-INR 980 crore range, which is largely on the back of the new supplies for our 351(k) interchangeable insulin.
What you saw in Q4 effectively is the ramp up of that market share from what Kiran just said, which we ended at less than 3% last year to actually the second piece moving up from there to, you know, into that 10% or the teens, as we would say, as we would move it forward. What will happen going forward is you will see that market share strengthen further and the profit share starting to move into the coming quarters towards the later half of the year. Now that's really how that market is expected to shape.
You will see us breaking through from that INR 750-INR 800 crore quarter range to the INR 950, INR 980, and then the subsequent quarters you will see us getting past the INR 1,000 crore mark in the first two quarters and then ramping up further. I would say that the way to read this is over a wider horizon rather than just a sequential number over one or two quarters past.
That's helpful, Shreehas. My second question is again on pricing environment for some of the products which we are anticipating to launch, say bevacizumab, once we get the final FDA approval. What we saw, in numbers reported by some of the competitors in the similar space, I guess the volumes were steady to growing, but even they mentioned decline in ASPs. Can you comment on pricing for some of the other biosimilars where we are looking to enter?
Yeah.
So, uh-
Sorry.
Go ahead.
I think, Damayanti, one of the important things to note is that, the pricing overall has remained same for a very long time. We do see pricing tending towards, a decline, which is also a factor of the competition that we see increasing the number of players there, which is expected when you have this kind of a market, condition. As you rightly pointed out, the CAGR in terms of the volume growth in the US alone has been at around that 4%-5% range. In Europe, even higher around that 14%-15% range.
The opportunity, the underlying opportunity is still sizable, still growing, and very few players who really had the opportunity to offer a complete product portfolio like we would have once we complete with bevacizumab as we come in. Once we get the agency to inspect us. I think one of the key changes from what we had discussed with you last time is that now we have the agency, post that dialogue that we've had, visiting us in Q2 of this year, and we should hopefully get past the approval stage shortly. Which then allows us to partake in this sizable opportunity alongside other players.
It will certainly be an upside which we had expected to happen in 2022, but now that the agency is finally able to make it to Bangalore, we will see that happening, as we go along the year.
Right. My last question, then I'll get back in the queue. Some of the programs, which I think we discussed during ma'am's opening remark, they are entering the clinic. In line with that, we have seen gross R&D jumping 30% sequentially. Over the next 12 months-15 months, how should we look at R&D spend as more and more of these programs progress in the clinical trials?
Yeah. I can respond to that. Chinni, would you want to talk about the R&D spends overall? Damayanti, let me give you a flavor of how we progressed. If you looked at how the R&D spends have been for the course of fiscal 2022, our programs, we had said, will be moving into the clinic towards the end of the year, and that's exactly what we've announced today. You've seen two of the major assets get into the clinic. We've announced denosumab as well as ustekinumab get into the clinic. You will see the R&D spends moving up in line with the progress of these molecules. But I'll let Chinni talk to the specifics on what those numbers would contribute towards and into the P&L.
Yeah. As this year we ended at 9%, as Shreehas just said. As we see the two new products enter into clinic, we expect R&D spends to increase in the coming quarters. Of course, the additional revenues from the vaccine, the Serum deal and the Viatris deal, will help us increase our investments in R&D as we progress our next wave of biosimilars. Overall, we expect R&D investments to be around 10%-15% of revenues going forward. Of course, quarterly distribution will be lumpy.
Thanks. I'll get back in the queue.
Thank you, Damayanti. We'll request all the participants to limit to two questions only, and we can follow up with additional questions. The next question is from Surya Patra from PhillipCapital.
Yeah. Thanks for this opportunity, and, congratulations for the good set of numbers, ma'am. My first question is again on the biosimilar sales. See, in fact, the sequential flatness what we are witnessing in the biologic sales, despite the ramp-up what you have mentioned about the ramp-up in the prescription for interchangeable insulin, which obviously would not have witnessed any pricing pressure as such. Even in the previous quarter, we had witnessed a delta of almost like $30 million in the biologic sales, so which the profit share of which would have come this quarter despite that and the branded pricing of this interchangeable insulin. Despite all these three factor, we have not seen any sequential improvement. It is just a flatness.
Although you have responded to that question, but I am still not understanding. Can you just clarify a bit more on it?
I think I just want to add to what Shreehas said and then Shreehas can add to what I'm saying. I think he mentioned very clearly that you have to look at this in context of what the sales values were before the Glargine kicked in. They were at roughly the INR 700-INR 750 kind of range in the first two quarters, and now they've bumped up to almost INR 1,000 crores. That is the addition of the Glargine sales for these last two quarters. Obviously we expect a further ramp up to take place because as you know, two of our programs, which was Aspart and, you know, bevacizumab have been delayed in terms of approvals for various reasons, largely attributable to US FDA not being able to come and inspect our facilities.
I think, you know, you can expect the ramp up to really happen in the coming fiscal. I think to really contextualize it on a sequential growth may not be the right way of looking at what Glargine has done for the business.
Sure. Okay.
Shreehas, you want to add to it?
Yeah. Just, thanks, Kiran. I think, Surya, just to comment further on what I said earlier and what Kiran's just saying, I think, the way to look at this would be to say that Q3 would essentially have marked the launch supplies as we send product from Malaysia into the channels. So making sure that that drove the day one sort of launch supplies into January 2022 as we got the product into the market. To view Q4 essentially as that shift-
Market share as it moves from that 3% into that 10% as we left March 2022. Effectively you're seeing Q1 as the quarter where we actually did the channel stock supplies, and then the other one where you're seeing increasing market shares as the second piece have gone up. What you will see happening through the course of the year as the market share ramps up further is you'll see a cumulative effect of launch supplies transitioning into repeat supplies and then increased profit share as the market share goes up.
I would say that to repeat it, not to look at it as just a sequential one-quarter, but take a broader view of a two- or four-quarter horizon, which then gives you a fuller picture on an annualized basis than just a sequential quarter, given the sizable shift that we will see in the U.S. market because of the 351(k) interchangeable lapse.
Sure, sir. Thank you. This is useful. My next question is on the small molecule side. You have mentioned about your entry into this injectable API in manufacturing, as well as further emphasizing on the expansion on the fermentation-based APIs. There is obviously on the integrated formulation business also that we are witnessing there is a steady progress. I think this space looks really interesting in the global market from here, given whatever the global situation that we are witnessing. That is also matching with your aggression towards building capability. If you can just give some sense on this business, say let's say two to three year time, given the ongoing project and the anticipatory project on the injectables and the complex product side.
What is the thought process there, and what growth contribution that we should be seeing over next three year time from this space?
Let me take that, Surya. Let me probably give a broad context before I specifically answer your question. As I've alluded to in the past that, I mean, you all are aware that we have a very strong capability and manufacturing capacities in the fermentation space since last two decades. We are building on to those capabilities by adding peptides, high potency oncology APIs, as well as large scale synthetic APIs. Now, that's purely from API perspective. As we forward integrate, we have formulations are spreading across orals, solids, injectables and various other forms of formulation. We are of course creating pipeline, a very strong pipeline in terms of differentiation and the complexity of these molecules.
We are not off chasing a large number of filings like many other generic companies do. We are looking at forward integrating as well as we do source API from outside if we find an attractive opportunity for a differentiated formulation. Now, as we add to the pipeline, we of course need manufacturing capacities. Today we do have a couple of injectable products which are manufactured in our biologics manufacturing site and a couple of CMOs. But as we get closer to the launch, we of course will have our dedicated facility for small molecule injectables. The construction on this facility is what's gonna start this quarter.
We also have, as you know, expanded our immunosuppressants API manufacturing capacity in Vizag, where the commissioning is almost complete and the validation would start this fiscal. That is only for immunosuppressant. We also see a huge potential for non-immunosuppressant APIs, and that's where the mention is that we are expanding our existing fermentation facilities in Biocon Park, where we will significantly enhance our capacities. The third is, we are building a very large scale synthetic API manufacturing facility in Hyderabad. Now, with all these investments and expansion of pipeline, advancement of our pipeline, of course, we will see a good growth coming in in the next couple of years.
I would not specifically give a number for next three years, but in fiscal 23, compared to fiscal 22, which we saw was flattish on an overall year compared to FY 21, but in FY 23, we definitely expect our growth to be there as some of the capacity enhancement projects are complete. We expect to start supplying from these facilities. We also expect launch of new products in the US in FY 23. I'm quite hopeful that we'll be able to deliver double-digit growth in the next fiscal.
On the CapEx front for this, can you give some sense? Are you becoming a bit more aggressive in terms of because of your capacity expansion plans, are you becoming more aggressive on CapEx front here?
No. I have always indicated that we are gonna be spending roughly $100 million of CapEx in a year for three years. Overall guidance has been $300 million of CapEx over a period of 2020-2024. We stick to that guidance.
Sure. I have a couple of questions. I'll come in the queue.
Thanks, Surya. Next one is from Harit Ramachandran from Spark Capital.
Good morning. Thanks for the opportunity. My first question is on the Vaccine Alliance with Serum. I believe you had talked about revenues of almost $350 million from this alliance in FY 2024. With the commercialization expected from second half FY 2023, do we have visibility on which of the products and the markets? I'm asking because this is almost 20% of the $1.8 billion pro forma revenues that you've guided for FY 2024, so it's a significant share of that, so any color that you can provide will be helpful.
Let me respond to that by saying that obviously it is not a particular segment of vaccines. We have access to the complete portfolio of vaccines. As you also know, the Serum Institute of India has recently received regulatory approvals from the European agencies, the Australian agencies, Health Canada, and also hopeful of getting a US FDA regulatory nod for their Novavax vaccine. It is not just the COVID vaccines that we are looking at, we are looking at many other vaccines. We remain committed to making sure that these numbers are a part of our future revenues. I think we are very confident that Serum Institute of India will provide these revenue numbers going forward.
As you yourself have mentioned, the numbers will only get reflected from the latter half of FY 2023, and then the full year numbers will get reflected from FY 2024. Serum Institute is very confident of providing us these revenues.
Thanks, that's helpful. My next one is on Bicara. So will you be able to share Biocon's stake in Bicara post the dilution which happened during the quarter? What I'm trying to understand is if there'll be a lower PAT loss pickup next year, and then this was around INR 200 crores in FY 2022. Just like to understand if this number would be lower in FY 2023.
Uh-
If you could also give a sense of the valuation at which this round of fundraise happened at Bicara.
Harit, the fundraise is not yet complete, so I don't want to discuss about the valuation right now because it's still the discussions are going on. While we have raised a certain amount in March, there's also additional amount being raised in this month, and there's also discussions going on, as I said, to raise further in this quarter. After all the rounds are complete, we, Biocon would just be around 50% of equity in Bicara.
Okay.
By June end, you can expect that Biocon will be at 50%.
Yeah. Yeah, last one with your permission. When I look at the R&D spends, there's roughly INR 300 crores of R&D spends outside Biocon Biologics, which I believe is primarily the generics business. If you could confirm that the INR 300 crores of R&D spends ex Biocon Biologics is primarily the generics business and some indication of the split between generics and novel biologics. Secondly, the R&D spends for the generics segment, how should we think about that for FY 2023 and beyond? Because currently, the profitability of our generics business is on the lower side, and that's primarily because of the higher R&D spends that we're doing for that business as the ANDA filings ramp up.
Is there a case for some kind of operating leverage kicking in in the generics business as the R&D spends flatten out or will it continue to increase, is what I'm trying to understand.
The R&D spend in FY 2022 was 12% of revenue. To be precise, it's roughly INR 250 crores on generics. Novel was a very small number because Bicara, of course, is not considered. The expenses on Bicara molecules are not part of R&D, and the only spend we have is on itolizumab and partially on tregopil. That's a very small number. For next year, I will continue to hold guidance between 12%-14% of generics revenue as R&D guidance.
Okay. Got it. That's all from my side. Thank you very much.
Thanks, Harit. The next question is from Prakash Agarwal from Axis.
Yeah. Hi. Good morning to all, and thanks for the opportunity and, congratulations on good numbers. My question is on, you know, the first one is on clarification on the R&D. When you say 10%-15% of sales, and normally you said biopharma sales. From second half onwards we will have Serum sales coming in, and we would have probably Viatris also kicking in. When we say 10%-15%, is it at what base? Is it biopharma ex of these or?
Chini?
Prakash, as I clarified earlier, it is on the total revenues, including.
Except the services.
Yeah, sorry. On the total biopharma biologics BBL revenues. That includes current BBL revenues, the new revenues from Viatris and-
Right.
Okay.
Okay, the new molecules that you have mentioned, the two new additions in the biosimilar pipeline, what is the approx cost coming for doing these now? I mean, in the past it had ranged from $50 million- $100 million. Currently, I mean, when we are looking at this, what is R&D budget approx we have for these kind of molecules? And correct me if I'm wrong, these are spread over four, five years.
Yeah, two to three years, but roughly along those lines, yes. $50 million-$100 million per product.
Okay. Because why I ask this is because when I see the competitive landscape, there are few players already in phase III. We have entered clinical now, so I'm trying to understand that, you know, we could be a little late in the game. What is management thought process here?
We are trying to basically see how close we can be to the LOE date on both these programs. We may not quite meet LOE dates, but we are trying to see as close as we can to the LOE date. Suffice to say that, yes, there are a few companies who have entered into phase III trials, but we also have a strategy to see how quickly we can catch up.
Okay, fair enough. With the background of this 10%-15% R&D guidance, which is fairly broad, what kind of margins we are looking at? I mean, would it be similar to what we are already having? Or is there a chance of inching up, given the pipeline, and insulin Glargine and other products start kicking in a significant manner?
Prakash, still encourage you to really focus on the core EBITDA, as you call it, before R&D.
Yeah, yeah. Whatever you can mention. In the core side also, do you think that margins could inch up, ex R&D as well?
I would keep it in the same length. Of course, as we consolidate the Serum and the Viatris business, we are giving you our guidance for FY 2024. That will give you the real picture of the combined business, the guidance that we have laid out for FY 2024.
Okay. Lovely. Thank you. That's all from my side. All the best.
Thank you, Prakash. Next question is from Sameer Baisiwala from Morgan Stanley.
Hi. Thank you very much, and good morning, everyone. Just for the in-market products, biosims in the US, what's the outlook, revenue outlook for Fulphila and Ogivri for fiscal 2023? Basically, I'm just trying to get to the volume price dynamics.
To the best of my knowledge, we've not probably given out product by product specific sales guidance and numbers. Chinni, do you have any additional color to that?
Sameer, again, at point where guidance was given post the Viatris acquisition, we've indicated that the FY23 growth will be biased towards Semglee. FY24 would be the full benefit of Semglee plus the launch of bevacizumab and Aspart. These are the key drivers of revenue growth before adalimumab kicks in. We've not currently modeled growth around the other products. Of course, we'll continue to pursue opportunities there too.
No, sure. I get that. I'm just trying to see what's the framework. I mean, do these products, you know, trend down gradually, or you think there is still some room to grow them? I'm not looking at any specific number. Just philosophically, how do you guys think about this?
Maybe we could ask Matt Erick to basically comment on that.
Yeah. I think if you look at our oncology portfolio, there's opportunity in both of those areas as we add Dofotamab to continue to grow that oncology portfolio. There's a great foundation there that really understands the buy and bill. Of course, there's some downward pressures, but it's also in regards how are you looking at this space and how can you continue to grow based on the market share piece. We have a great foundation to do that, and I think that will give us that opportunity to continue to grow in that market and be successful.
Okay, great. The second question is about the contracting outlook for insulin Glargine for calendar 2023. I'm just trying to not trying to get to any market share number. I'm just trying to understand how does the system work. Do you retain your current contracts that you are enjoying in 2022 and then build over it, or do you start all over again? Any flavor on that would be great.
Matt, do you want to talk to that?
Yeah, sure. Thanks, Riaz. Thanks for the question. Look, all those relationships are important. Again, leveraging the franchise from a standpoint in diabetes, to continue to grow on that and grow that portfolio is very important as you deal with payers, in that diabetes space. We'll continue to work with them, as we add additional products within diabetes.
No, no, Matthew, I'm not asking about adding new products. I'm asking about the current in-market product. How does the system work? You know, how does the contracting for 2023 will work? Do you start all over again, or do you build on the current contracts and grow that?
Sure. Thank you for that. Sorry about that. Look, the contracts do come up each year. Once you're in that contract position, you do have an advantage from that standpoint to renew, because you're in that position in regards to current payers and the formularies there. We'll continue to maintain those relationships and that market share and build, and then continue to build upon that with an additional payers as we go into the following years.
Yeah, good. That's great, Matthew. That's very clear. One final question from my side. How are we thinking about Aspart in terms of resolution of the pending CRL and the regulator's visit to our facility? You think, you know, you can still be in time to contract for calendar 2023 for Aspart?
Yeah. Thanks, Sameer, for that question. As you know, when we had received the CRL, we had pointed out to the two aspects that the agency had raised a question. One was regarding the diluent that is used, particularly for a small segment of pediatric patients, largely we needed it alongside the vial. The other one was related to further updates on the CAPA actions that we had provided for the observations that the agency had made during the inspection. Now, we have, you know, been in constant dialogue with the agency, and we've responded to the CRL based on the conversations that we've had with the agency earlier this month. Our response to the CRL has been sent.
We expect the agency to now move on that to see that it gets towards approval. Now, whether it will be exactly in time for the formulary contracting cycle, that's our hope. I know we've discussed that before as well. But that's the discussion that will be ongoing with the agency. It'd be unfair on our part to probably commit on behalf of the agency on when they'll be able to approve the product.
Thank you, Sameer. Next question is from Ankush Mahajan, from Axis Securities.
Thank you, sir, and congrats for good set of numbers. My question is, there is a fall in gross margin. That's especially in gross margins. What is the impact on gross margins if there is any fall in realizations? I want to say, if you see, in the US market, in Fulphila we have gained the market share, and Semglee we have gained the market share. This gaining market share due to the fall in realizations, any impact on gross margins?
Ankush, hi. I'll just speak specifically for the biopharmaceutical business. We have seen improved margins this year. Our core EBITDA margins has gone up from 36%-39% for the full year, 520. Our Q4 margin is also in line with that margin for the full year.
We just go through some items, generic business, the Q4 growth is 70%. That's a good growth. How do you see the competition in generic segments are going onwards, especially the price erosion? No doubt there is new launching, and new launches are there, but what about the price erosion? How could we see the growth in this generic division?
I think, Ankush, I already mentioned to address this in a previous question that we do expect new launches coming up next year, both in our API business as well as formulation business. It should drive double-digit growth, of course, in teens. From a pricing perspective, there are headwinds in the market, especially in the U.S. There are many reports already there that there are continued pricing pressure. It has impacted all the generic companies. We have also been impacted. Now, you have to choose whether you continue to be part of that pricing pressure and continue to lower your prices, or you opt out of some of these tenders. Of course, we have to do both and depending on the circumstances.
I can also request Abhijit, who heads our generic formulations business, to add his perspective.
Thank you, Siddharth, for that. Yes, you're right. I think you summed it up correctly that the pricing pressure is there, and the key is to add new products. We are planning for new launches, both through strategy of licensing products as well as internal pipeline kicking in. You would see more launches as we grow in this business.
Thank you, Ankush. The next question is from Nithya Balasubramanian from Bloomberg LP.
Thank you. First one is actually on Humira. There are obviously multiple factors at play here, interchangeability, the citrate-free formulation, the low dose versus high dose. Two questions. One is, what is Viatris' product presentation? Are you likely to go after interchangeability at some point? Two, based on your recent conversations with payers, what are you picking up as important factors? Is interchangeability important? How important?
Thanks, Nithya. I think this is a topic of interest for everyone. I think we're watching this closely as well. I think let's get the two key things out of the way first. I think one aspect is to have the right product formulation, which is, as you rightly said, a citrate-free formulation. That's something that we can confirm that Viatris has been able to secure. The other thing is to see that we get the approval for all indications. That's something that we can confirm as well. I think that out of the way, basically now, looking at the other variables that are under discussion, which are whether it's the strength of the formulation, whether it's interchangeability to the device versus the syringe.
I think these are conversations which are currently ongoing with also the citizen petition that's been filed at this point in time. Different players will probably launch with a different approach. Some with a high strength, some with low, some with an interchangeability study and some without. I think the key nuance here is that while the agency will provide guidance on some of this in the coming days, is the interchangeability aspect here, although important, is probably really commercially relevant to the first player who would have exclusivity for a period of one year post-launch. That is really gonna happen with the first player getting into the market. There will be others who will conduct similar studies, and we've seen other players have that as well.
The aspect of making a difference commercially will play out only at year-ends, considering that interchangeability is a consideration for a product of this kind. Given that there are going to be, you know, close to a dozen players or ten or eleven players in the opportunity, with the pie being as sizable as it is, I think there is gonna be room for almost everyone to play. If you were to look at the question that you asked on what are we hearing from players, I think there is still that wait and watch in terms of how the market is gonna shape up and what is the offering that each player is gonna bring to the market.
Clearly, as I said before, there is gonna be ample opportunity for everyone to play because of the size of the opportunity that we're talking about.
Shreehas, can I summarize that as maybe 2023 might not see as much biosimilar penetration as you would anticipate, given that players are likely to wanna wait to see what is the product presentation, who has interchangeability, who doesn't?
No, I think that would be probably jumping the gun to say whether there will be sizable or not. I think there will be a tiered entry with Amgen entering first, as we now know publicly, and then a whole bunch of companies entering towards the second half of the year. While each one will have a different proposition, I would refrain from commenting on commercial strategies and how we expect to win in the market. I'll probably, you know, reserve it for a later date as we get closer to launch.
My other question was also, are you likely to chase interchangeability?
This is another aspect. As I said, we will, you know, we've been watching this closely and, given that the timing of the interchangeability study really matters to only the first player, and then everything else is really a year later from them, we are committed to doing whatever it takes to be successful in that. Interchangeability study is one of those things that we could be considering as well.
One last one on vaccines. I think there were reports last week that Serum Institute is sitting on a large pile of vaccines with not enough takers. Now that you're closer to kicking off the deal with SII, what is your latest visibility on your ability to push the 100 million doses in a year for the COVID vaccines?
As I mentioned, Nithya, it was not just about COVID vaccines. Yes, while they are sitting on stock of, basically the Covishield vaccines, I don't think they are sitting on such a large stock of other vaccines.
Sorry, correct me if I'm wrong. I thought FY23 and FY24 is COVID, and what's in the pipeline is likely gonna-
No, no, I'm saying that the stock that he's talking about is the Covishield vaccines. They also make, as you know, Covovax.
Yeah.
All the other vaccines, which are non-COVID as well. What we are, we have access to is every vaccine, that they manufacture. I would not draw any conclusions from the statement he has made just on Covishield vaccine, overstocking.
Sorry, I'm just gonna push for a bit of clarity here. When you say all other vaccines as well, are you talking about the MMR and the MR and the typhoid vaccines as well that SII is producing? Do you have access to those in the near term?
Yes, everything is what we have access to, but I just want to caution you that don't draw conclusions from the statement that he has made, which really pertains to Covishield vaccines.
Understood. Thank you.
Thanks, Nithya. Next question is from Surya Patra from Bank of America.
Thanks for the follow-up. In fact, for the Malaysia plant, you mentioned about that achieving positive profitability this year. Could you clarify what is the number of revenue in terms of EBITDA from that setup? Because potentially that should see a kind of meaningful improvement in FY 2023. That is the first question.
Nithya, that's, maybe you may want to take it. You're on mute.
Sorry, Shreehas. If we just give a perspective of how Malaysia is ramping up, and I'll share the numbers. Surya, did you have a second question? I didn't.
Yeah. I have a second question as well. I just wanted to have a sense, so say on the biosimilar, this new Biosimilar User Fee Act, what it has been approved. Do you think a greater competition that would be likely to come in the overall biosimilar space and more and more interchangeabilities opportunities will be competing with each other? Hence, the way the competition that we have witnessed in the normal generic business, chemical-based generic business, similar trend can possibly emerge in the biosimilar space. Is that the concern or there is some opportunity that you find from the Biosimilar User Fee Act?
Let me first take a shot at answering your question. First and foremost, we are watching the interchangeability space. I might also mention here that Biocon is a frontrunner when it comes to having a combined portfolio of insulins and mAbs, which I think is a unique portfolio offering that we have. We do believe that we have this early mover advantage in the insulins interchangeability space. We will look at obviously the mAbs interchangeability and have a strategy for that. I think these are early days, and we will have to see how we can basically take advantage of interchangeability or not.
Sure. About the Malaysia plant, sir, if you can respond.
What was your question about the Malaysia plant? I thought Chinni had already.
Okay.
No, I'll just add the numbers, Kiran.
Yeah.
You're talking EBITDA in the $20 million range and PAT in the $10 million range. That's on a quarter basis.
No.
Yes.
For the FY 22 as a whole, sir, I think.
No, on the.
That was a loss-making setup.
On a full year basis, as we indicated, we've been incurring losses in Malaysia, but Q4 reflects the turnaround, and that will be the basis to look ahead. There's no point in going back.
Okay. Just one more clarification I wanted about the loss from the associates and JVs. See, I believe what we have reported this quarter is something like more than INR 50 crore losses. This was expected to be the last quarter of such charges. Some clarity on that, and also whether it is only related to the Bicara-related charges or it is something relating to even the UAE subsidiary or UAE JV, which now we have activated. Can you just clarify on this and whether we should build more charges, similar charges, even in FY 2023?
Siddharth, maybe you want to take this.
Yeah, Surya, it does have a component of our joint venture in UAE, small though. We have not reactivated that joint venture. Let me clarify that. We are going direct in the market for our own drugs. But we still have certain products in that joint venture. Unfortunately, because of legal issues going on with our joint venture partner, we cannot wind down this entity, so we are gonna sunset that business in the next year. Of course, that business is profitable, so there is a profit aspect of that joint venture in the number. The number primarily, as I said, is from Bicara. Bicara, you are right. The expectation was that whatever we had at the end of quarter three would exhaust by quarter four.
We also had given a debt to Bicara in the previous quarters. In line with fundraising that Bicara is doing, we have taken a decision to convert that debt into equity. Of course, we have not pumped in additional cash into the business, and hence, the loss pickup was higher this quarter. We have, actually, the carrying value of $10 million as of end of March, which will come as a loss pickup in the next fiscal.
It could be.
There is a step-up gain that happens as the fundraise, as Bicara continues to do fundraise. There is a step-up gain on the existing investment that happens as per the accounting standards and that kind of adds to the, I mean, the-
Mm-hmm.
It gets offset against additional expenses that come in the next quarter, but there could be a mismatch between when the step-up gain happens and when the expense against that gets offset.
That means this $10 million will be evenly distributed across the four quarters next year or-
No. It would be first come, first serve basis. I mean, in the sense if 10 million, of course, the run rate or the burn rate for Bicara is gonna be lower. It's gonna be approximately $5 million-$6 million. Looking at our equity of 50%-60%, we will have a loss pickup of roughly $3 million-$4 million, and that will exhaust as soon as the $10 million gets exhausted.
Sure. Okay. Yeah. That is it, sir. Thank you.
Thanks, Surya. The next question is from Tarang Agrawal from Old Bridge Capital.
Hello, good morning. Two questions from my side. One, you know, just to get a better sense on the biosimilars business, you know. While building in a product and, you know, deploying the R&D dollars there, what's the ballpark EBITDA margin that you'll bake in, you know, post-amortization of all the R&D spends? You know, because I ask this because when I look at a core EBITDA margin today, INR 1,000 crores of revenue and 39%, it really doesn't accommodate for the R&D spends that might have been incurred on the project, on the products historically. Just to get some sense that if on the INR 1,000 crores that the business is running, earning today, what would really be the margin on the business?
I'm not sure if I was very clear on what I'm trying to understand, but.
I think, you know, we have indicated that, you know, this is net of R&D of course. You know, when you talk about core EBITDA margins, it excludes R&D. I think we also indicated that the R&D spends you should factor are roughly about 10%-12% of revenue. If you were to look at it that way, and of course it gets lumpy, so some quarters it might even get to 15%. I think, you know, you need to factor that R&D spend and then calculate the, you know, the EBITDA margins based on that. If you were to look at that, then you're down to about 26%-27% EBITDA range. As you know, you know, without investing in R&D, there's no future growth.
Yes, ma'am. Ma'am, basically what I wanted to understand was that today with Peg, trastuzumab, Insulin and a host of other biosims, that are currently in the portfolio and generating INR 1,000 crore of revenue on a quarterly basis, would it be fair to presume that these products would be generating maybe 25%-26% EBITDA margin, assuming that the R&D spends that were incurred to bring these products online, would be amortized over the revenue generating life of these products? I'm not talking from an accounting standpoint.
Uh-
I'm purely talking from a cash flow standpoint. If it's-
Sure, sure. I understand what you mean. Maybe Chinni wants to take this.
I'll clarify, and then Arun if you could just give a color on overall R&D. Just specifically on the numbers, Tarang, the core EBITDA margins before R&D really reflects what we're earning on the past investments that we've made and products that we've brought to the market. Today our sales of trastuzumab, Peg and now insulin Glargine is reflected in our revenues and the core EBITDA margins indicate what we are earning from this business. With that.
I hope that helps, Tarang, because I think what he's saying is that once you make those investments, obviously your margins are much higher. I hope I answered.
Not really, but I'll probably take it offline. I think I'll be. Can I, if you may, just probably take two more minutes. Hypothetically, say INR 1,000 crore or INR 2,000 crore were spent on R&D for these three products, okay? Over the life, I mean, historically, over the last six, eight years, okay? Assuming that entire amount was sort of capitalized. Assuming, I'm not saying it has. Assuming that was capitalized, and now once these products start generating revenues, right? I start writing off those 1,000, 1,500, whatever I spent on R&Ds over the lifetime of the products, will it probably fetch me what I'm really earning out of those products today? That is the figure that I'm looking at.
I'm not saying I don't want you to give out the figure for the current INR 1,000 crore pipeline or INR 1,000 crore revenue. I'm saying what is it that you all sort of forecast when you're building it?
Tarang, let me answer that question by saying that, look, Chinni just mentioned that. Let's look at today's numbers in biosimilars. It's actually pertaining to the products that you have that are in the market, right? It does not reflect the current R&D spends on those numbers.
Right.
It actually basically takes into account all the R&D that has gone into shaping these molecules, right? Basically, if you look at the way we capitalized all the R&D spends, and if you look at your core EBITDA numbers, it includes the amortization on these spends at the current levels. What you are now saying is that the only thing that you're now having to factor is the additional R&D spends.
For the future pipeline.
If I may, Tarang, I'll just clarify one more time. Basically, when you say core EBITDA, core EBITDA excludes R&D spends.
Exactly.
On both new programs or old programs. Most of the old programs were either expensed out-
Capitalized.
Treated as such and some portions capitalized, and those capitalized are being amortized below the line, below core EBITDA. When you look at core EBITDA, that's really giving you the true picture of revenues and I mean, profits on past investments.
Okay. Thank you. Just a second question from me. The INR 3,400 crore of CWIP on the balance sheet, what would be a major portion of that? And what would trigger the capitalization of it and further impact of that on the P&L, annual impact of that on P&L? Cost impact.
Shreehas, you wanna talk through the expansion and the drug substance capacity?
Go ahead. Go ahead.
Tarang, yes. The CWIP largely represents expansion of our drug substance capacities for mAbs. We expect one of these facilities to come online in this fiscal, that FY 2023, and the other second facility to come online in FY 2024-2025 timeframe.
As they come online, they will of course give us additional opportunities, particularly as bevacizumab gets approval. We will have additional capacities to service that. On the flip side, you will have increased depreciation, interest and other costs associated with the facility.
Thanks, Varun. The next question is from Vipul Kumar Shah, an individual investor.
Hi, congratulations for good set of numbers. I have two questions. What was the capacity utilization of Malaysian plant? Second, what is your guidance for full-year losses for novel biologics program? Thank you.
Let me take the first one, Vipul, which I think if I heard you correctly, the question was, what is the capacity utilization as we see in Malaysia? That was your question. I see. I think the important thing is, to see that the capacity utilization over the second half of the year, in Malaysia has significantly improved over the first half of the year and is reflected in the supplies and the revenues that we've got, during the course of the second half of the year. We've also, you know, guided that we are making investments in, expanding capacity further as we see, not just increased interest in the products that we've brought to the market, but also for products to follow.
We will seek capacity expansion further in Malaysia for that product and that substance in the years to come. Clearly, capacity utilization of our current investments has grown significantly, leading to that Malaysia facility turning a profit towards the end of the year as we closed and exited fiscal 2022. I think your second question was more related to novel. Couldn't hear that very. If you could repeat that maybe, Siddharth, you could take that.
I think what is your guidance for losses annually for novel biologics program for FY22-FY23? Regarding Malaysia, my question was what was the exit capacity utilization for the fourth quarter? Thank you.
Vipul, let me take the guidance on novel, and I would talk more qualitatively rather than numbers. I think I've already indicated that we have very small spend on itolizumab. The tregopil trial is also complete, so there we do not expect any additional costs coming in for tregopil. The BCA101 or the Bicara trial, which is ongoing, again, the cost is not coming in the R&D expense. It's coming through the cost of JV. More directionally, as Kiran had mentioned in the opening remarks, that itolizumab started a phase three trial for acute GVHD, and it's a global trial, so we expect significant progress to be made over the next two years from a clinical perspective, for itolizumab.
We are also gonna start maybe another trial for an indication in India in this fiscal year. We have the BCA101 or Bicara clinical trial going on in the US. Again, we expect our data to come out in FY 2023 and 2024. Those are the two lead molecules that we have where we do expect progress over the next two years.
Vipul, the next question is from Prakash Agarwal from Axis.
Yeah. Thanks for the follow-up. A quick one here. On the gross margin side, we are seeing some drop, partly I think due to Syngene research services and partly maybe higher, you know, input costs. How do we see fiscal 2023, given that, you know, most of the other products launch is now calendar 2023. How do we see fiscal 2023 for the gross margins please?
Let me just break it up. Generics is down 2% on a full year basis, biosimilars is down 2%, and research is down 5%. Generics is down mainly because of increase in input costs and the solvent prices. I don't see, at least in the generics business, a recovery in gross margins next year. We do expect to continue at the similar levels as the full fiscal of 2022.
BBL?
Chinni can answer, but again, there are, as you know, many moving parts in BBL because of Serum and Viatris. Chinni can hazard a guess.
Just broad colors should help.
The base business, as we see an increased revenues and profit share coming from the US markets, our overall gross margin should be maintained. I take it that when you say gross margin, you're saying revenues less material costs.
Yes, sir.
Not to correlate with the market, right?
Yes.
Gross margin we should be able to manage within a 1%-2% range.
Okay, sir. Thank you. Second one is on the Biocon Biologics IPO timelines. In the past we have said
12 months-18 months, is it still looking that way? Or, given that so much development, reactors, and setup, et cetera has happened?
Yeah. Obviously it is going to be pegged to the date of closure and the way we can basically integrate the business. Obviously we will look at that and then decide the timing.
Right. Perfect. All the best for that. Thank you.
Thanks, Prakash. Given we are running out of time, I think we'll take one more question, for the day. The next question is from Nithya, from Bernstein.
Yes. Thank you. Two quick ones. On Stelara or Ustekinumab, there are two product presentations, the IV one and the injection one. Are you chasing both? The second one is what color can you give us on the Sandoz programs?
Nithya, on the ustekinumab, the response to that first question is yes, we're chasing both. The question that you had, pipeline, I think we are looking at products which would basically have market formations towards the end of the decade, and that's something that we've been working on. As these products progress towards that, we will be bringing more information out into the public domain.
As of now, everything is pre-clinical. Is that how we should read it?
Yeah, right now in the pre-clinical stage, yes.
Thank you so much.
Thank you. We have one more question from Dinesh Mahajan. We'll quickly take that as well. Dinesh, please, go ahead.
Am I audible?
Yeah.
Yeah. Thanks, and congratulations for good set of numbers. I've been a practicing doctor, like India being the diabetes capital of the world and, right now, the management seems to be more focused about the U.S. market. Any special strategies we have to grow the Indian market share when it comes to Basalog or Insugen or your diabetes portfolio you have for the Indian market? Like I see MNCs dominating in India. Does Biocon has any special strategy in place, or are they focusing on growing market share in India?
Susheel, maybe you want to answer this.
Thank you, Dr. Dinesh, for that question. India business to us is very, very important. It's a home country for us, and it's important that we drive market share in India, and we are very, very conscious about that as well. In terms of Basalog, the interchangeability study, for the science that we are selling had a very strong impact on the doctors in India. The focus is very high in terms of field force. We have ramped up our field force as well. We know the needs of education, the needs of training with our field force will only go up, and that's where we are focusing. A lot of focus being done in India on sales force excellence and also high scientific activities with doctors, in the country as well. We are driving very strongly with that.
In FY 2022 we are seeing results come in as well, indicating towards increased market share. The focus will be there very strongly on India, not only for diabetes, but also for oncology and the other portfolio that we have.
Okay. Thank you. One more if I may. Madam, like the Biocon Biologics will be listed as a separate entity. Anything what the old, your previous Biocon shareholders should look at? Any share listing for them or any other opportunity for them?
At this point in time, I really won't be able to say much, but, you know, we are quite a while away from the IPO, so let's wait.
Okay. Thank you, madam. Thank you.
Thank you, Dinesh. Thank you, everyone. That was the last question of the day. We thank you all again for joining us today. If you have any additional question, please feel free to reach out to Aishwarya or me. We look forward to seeing you again next quarter. Have a good day.
Thank you.