Good evening, everyone. I'm Saurabh Paliwal from Biocon Investor Relations team, and I would like to welcome you to Biocon's Earnings Call for Q2 FY 2024. I would like to indicate that all participants will be in the listen-only mode, and there'll be an opportunity to ask questions after opening remarks conclude. Should you need to raise questions, please use the Raise Hand option under the Reactions tab of the 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 the chat box is disabled, but you can raise any technical concerns by sending us an email to investor.relations@biocon.com. I would like to bring to your attention that this conference call is being recorded.
The recording will be made, made available on the website within a day, and the transcript will be made available subsequently. Today, to discuss this quarter's business performance and future outlook for the company, we have Dr. Kiran Mazumdar-Shaw, our Executive Chairperson, Mr. Peter Bains, Group CEO, Mr. Siddharth Mittal, MD and CEO, Biocon Limited, Mr. Shreehas Tambe, MD and CEO, Biocon Biologics, along with other senior management colleagues across our business segments. Before we begin, I would like to point out to everyone the safe harbor related to today's call. Comments made during this call may be forward-looking in nature, based on management's current beliefs and expectations. They must be viewed in relation to the risks that our business faces that could cause our future results, performance, or achievements to differ significantly from what is expressed or implied by such forward-looking statements.
After the end of this call, if you need any further information or clarifications, please do get in touch with the team. With this, I would like to turn the call over to our Chairperson for her opening remarks. Over to you, Kiran.
Thank you, Saurabh, and good evening, everyone. Let me begin by wishing everyone a very happy Dhanteras and a very, very happy and prosperous Diwali. Let me wish you all health, happiness, and prosperity in your homes, and let's hope that the year ahead is going to be very prosperous for all of us and for our country. I would now like to provide you with a broad overview of the group financials. Total revenue for the quarter was INR 3,620 crores, up 52% year-on-year. Revenue from operations increased by 49% year-on-year to INR 3,462 crores, with biosimilars revenue almost doubling, of course, reflecting the acquisition from Viatris. Research services delivered a strong revenue growth of 18%, while generics grew by a modest 4%.
Core EBITDA grew by 35% to INR 1,100 crores, reflecting a healthy core operating margin of 32%. Let me now introduce two senior executive appointments. Mr. Kedar Upadhye, who joined Biocon Biologics as the new CFO. Kedar brings over 23 years of global financial leadership in the pharmaceutical industry. His deep experience and expertise will enhance our ability to unlock and drive future value in Biocon Biologics. Secondly, I would like to welcome back Mr. Peter Bains, who, as you know, assumed the role of Group CEO of the Biocon Group in September. Peter will be responsible for supporting me in evolving strategy and driving synergies between the three group companies, and this is with an aim to maximize their combined value for all stakeholders.
Peter's comprehensive understanding of the Biocon Group, coupled with his extensive global leadership experience and successful track record across the biopharmaceutical sector, will enable us to capitalize on the shared value of our three businesses and add impetus to the group's growth trajectory. On that note, and as a part of Peter's new role, I would like to hand over the floor to Peter, who will lead the earnings calls going forward. Over to you, Peter. Peter, this is over to you now.
Peter, you're on mute, Peter.
Okay. Thank you, Kiran, and good evening, everybody. Let me first of all say how delighted I am to be rejoining Biocon. It's a real privilege and pleasure, and I'm very excited to be rejoining the group at such an exciting and dynamic stage of its evolution. Before discussing business performance, I want to take this opportunity to welcome other new leadership hires in the group. In Biocon Biologics, we have three appointments. Dr. Uwe Gudat joins as the Chief Medical Officer. Dr. Arlene Wolny joins as Global Head of Regulatory Affairs, and Mr. Ramprasad Bhat joins as Head of Branded Formulations in India. At Biocon Limited, Mr. Nitin Tiwari has been appointed as the Head of Quality for the generic business. Let me now expand on Kiran's opening view on the performance for the quarter.
As Kiran stated, total revenue and core EBITDA for the quarter were INR 3,620 crore and INR 1,100 crore respectively. R&D spends for Q2 stood at INR 264 crore as compared to INR 242 crore last year, corresponding to 10% of revenues excluding Syngene. The R&D investments are largely attributable to advancing BBL's strong pipeline of biosimilar molecules, as well as developing new peptides with a focus on GLP-1s in our generic business. The benefits of these investments in research and development are expected to play out in the coming years. EBITDA for the quarter was up 68% at INR 900 crore versus INR 535 crore last year, with an EBITDA margin of 25% as compared to 22% last year.
Depreciation, amortization, and interest increased by INR 376 crore over last year, primarily related to the biosimilar business acquisition costs. Consequently, profit before tax and exceptional items stood at INR 238 crore, marginally down from last year. Net profit for the quarter before exceptional items stood at INR 142 crore as compared to INR 168 crore in the previous year. Exceptional items during the quarter amounted to INR 16 crore, net of tax and minority interest. These relate to the reversal of Production Linked Incentive Scheme accruals of the last fiscal, consequent to the cap on annual claim allocations, as well as transaction cost of the proposed Stelis facility acquisition by Syngene. Exceptional items last year amounted to INR 122 crore, and therefore, reported net profit stands at INR 126 crore as compared to INR 47 crore last year.
Let me now turn to discuss the generic business segment performance. Generics reported an operating revenue of INR 676 crore for the quarter, a growth of 4% over the same period last fiscal. Core EBITDA margin for the quarter stood at 23%, with profit before tax at INR 66 crore, representing a profit before tax margin of 10%. Revenue performance for the quarter was driven by continued traction in the U.S. generic formulation business, through additional volumes in statins and recently launched products, and most of the world market expansion. On the API side, performance was muted due to phasing of supplies because of a planned maintenance shutdown for one of our key products, as well as pricing pressures. We made two significant announcements during the quarter.
First, we announced a partnership agreement with Juno Pharmaceuticals, a specialty pharmaceutical company in Canada, for the commercialization of liraglutide for the treatment and management of type 2 diabetes and obesity in Canada. Secondly, as part of our plans to strengthen our foothold in the North American market, Biocon acquired the oral solid dosage U.S. manufacturing facility of Eywa Pharma, located in New Jersey. The acquisition of this U.S. FDA-approved facility, our first in the U.S., will strategically enhance and complement Biocon's existing manufacturing capabilities. The facility will enable the immediate addition of oral solid dose capacities for new products earlier than planned and ensure continuity of supply through the diversification of our manufacturing infrastructure. The facility's employees have transitioned to Biocon, and the process of qualifying the site for some of our products has already been initiated.
We are pleased to see positive outcomes on the regulatory front, with several generic formulation approvals obtained in the quarter: one in the U.S., two in Europe, and four products in most of the world markets. Further to this, we've received two API product approvals, each in the United States and in Europe. Regarding our capital expenditure program, we crossed an important milestone in the quarter with process validation at the company's greenfield immunosuppressant API facility in Visakhapatnam, which is now successfully completed. We now expect commercial supplies to begin in full year 2025, post-qualification of the site by global regulators. This new capacity for immunosuppressants will enable us to diversify our manufacturing footprint and address the growing demand for these products globally. In the second half of the year, we see a mix of both opportunities and challenges.
On the generic formulation side, we expect a sustained performance supported by a gradually improving environment in the U.S. market. On the API side, we anticipate some recovery. However, pricing pressure and higher inventory stocking at our customers could impact offtake. The recent and successful outcomes from inspection of two of our sites by the U.S. FDA reiterates our commitment to quality excellence as we continue to work on strengthening our mid- to long-term proposition with increased investments in portfolio, R&D capabilities, and infrastructure to deliver on our strategic plans. Moving now to Biocon Biologics. Let me start by providing an update on the transition of the acquired business from Viatris to Biocon Biologics. Our accelerated integration plan has been progressing well.
In addition to the 70 emerging markets transitioned in July, we have now fully completed the integration of the North America business, resulting in seamless commercial operations in the region from September 1st. We remain on track to transition the business in Europe, Japan, Australia, and New Zealand, and the remaining emerging market countries later during the year, which will complete the integration of the acquired business. The transition and integration of the two businesses is a critical milestone in our journey, as it enables the most important strategic rationale of the acquisition, and that is the creation of a globally scaled and fully vertically integrated lab-to-market biosimilar enterprise. Turning now to the business performance, and starting with the United States, we continue to see good momentum across our oncology and our insulins portfolio.
Fulphila, our biosimilar pegfilgrastim market share, has grown to 19% in September versus 11% last year. Market share for Ogivri, our biosimilar trastuzumab, stands at 12% versus 10% last year. We continue to add new customers for these products. A large benefit provider, covering 100 million lives, has added Ogivri and Fulphila to their 2024 medical drug lists, enabling further market share growth in the coming year. Market share for our insulin glargine is at 11% in September. The volume supplied through a large managed care network contract, not captured in these market shares, is over and above the IQVIA data. Furthermore, starting in January 1, 2024, we have added 2 large payers to our insulin glargine customer base, which should help further enhance our market share.
These strong market performances of our products demonstrate the commercial capability of our U.S. team, and continued addition of new customers for these products enables volume growth, accommodating for price erosion. Turning now to adalimumab, the market adoption of biosimilars has very clearly been slower than anticipated across the market, and of course, this has also affected Hulio, our biosimilar adalimumab. Notwithstanding these early market dynamics, our focus remains on expanding market access to drive adoption. We remain engaged with customers to add our product to their formularies, and I'm pleased to share that our product has been enlisted with the commercial standard opt-out formulary of a large purchasing organization and corresponding managed Medicaid business, covering over 8 million lives. It has also been added to the National Preferred Formulary for Medicaid members, one of the largest Medicaid managed care organizations, covering 7 million lives.
Turning now to Europe, our products continue to make steady gains. The market share of Fulphila has grown to 8% against 5% last year, and Abevmy, our biosimilar bevacizumab, has grown to 7% against 1% last year. Hulio continues to have market shares of 18% and 11% in Germany and France, respectively. As we complete the transition of the business in Europe to a single fully integrated model, we see the potential to improve business performance. In emerging markets, Biocon Biologics remains on a steady growth trajectory, supported by continuing strong demand for insulins. We continue to increase the depth and breadth of our emerging market franchise. In quarter two, there were 4 new launches and 11 new approvals, laying the foundation for future growth.
Aligning with our global product focus, we announced the divestment of two non-core branded formulations, India business units in dermatology and nephrology to Eris Life S ciences for INR 366 crore, representing a revenue multiple of around 4%. Now coming to the financials of Biocon Biologics. On a sequential basis, we have seen revenues marginally down by 2% at INR 1,969 crore, despite significantly lowering licensing revenues versus last year. Excluding these licensing revenues, sequential growth stands at 6%, reflecting the underlying positive performance of our commercial products. This has translated into a core EBITDA of INR 660 crore, with margins at 34%, in line with our mid-thirties guidance. EBITDA margin for the quarter was 23%, with R&D investments at 11% of revenues.
Profit before tax stands at negative INR 15 crore, driven by an increase of INR 35 crore depreciation, amortization, and interest costs. PBT is expected to improve with future growth in revenue. Now moving on to regulatory updates. The European Commission has granted marketing authorization in the European Union for Yesafili, our biosimilar aflibercept, indicated for macular degeneration and diabetic retinopathy. As per IQVIA, aflibercept had E.U. brand sales of approximately $1.8 billion last year. The U.S. FDA has issued a CRL for the BLA of our insulin aspart, which did not identify any outstanding scientific issues with the product and references the requirement for satisfactory resolution of deficiencies from the pre-approval inspection of our Malaysia facility. Separately, the FDA conducted a cGMP inspection of the Malaysia facility in July 2023, leading to observations primarily related to enhancing operational procedures and strengthening training programs.
We are fully engaged with the agency to resolve all outstanding concerns. In summary, we are pleased with the accelerated progress in transitioning the acquired business and with the growth in market share of our commercialized products. While there has been delay in the activation of our immediate near-term catalysts, biosimilars adalimumab, aspart, and bevacizumab, these remain to be future growth drivers. And beyond these, and reflecting the strength of the Biocon Biologics pipeline, other future growth catalysts, including biosimilars to aflibercept, ustekinumab, denosumab, represent total original sales opportunities of $25 billion in sales. Turning now to novels. And on the novel side, Bicara recently presented updated and positive interim data from its ongoing open label Phase I, 1B dose expansion study of BCA101 at the European Society for Medical Oncology, ESMO Congress.
There was strong investigator interest shown for these data, and Bicara is now well-positioned to execute on its next round of funding, advancing BCA101 and progressing its pipeline. To remind you, Bicara had announced a $108 million Series B financing earlier this year, which is being realized in a staged manner. Because of this, during the quarter, we recorded a step-up gain of INR 75 crore in the consolidated P&L statement. Turning now to research services. Revenue from operations for the quarter was up 18% to INR 910 crore over last year. Reported EBITDA was up 19% to INR 276 crore, with an EBITDA margin of 30%. Profit before tax was up at INR 158 crore, 22% over last year.
The performance during the second quarter was bolstered by strong performance in development and manufacturing services and supported by sustained momentum in the dedicated centers. In manufacturing services, Syngene continued to make good progress on the long-term biologics manufacturing partnership with Zoetis. Coming now to some concluding remarks, and I think that overall, we are very pleased with the progress the group has made in the quarter. Biocon Biologics is on track with its, its accelerated transition program to create a fully integrated and globally scaled leading biosimilars enterprise. This will advance our ability to leverage the benefits of the fully integrated model and to expand our footprint in the United States and Europe, and the most of the world markets, in addressing the growing global demand for biosimilar products.
The sustained momentum we've seen in the market share gains with our commercialized products in the United States and Europe as we complete the transition, demonstrates the effectiveness of our commercial engine. As well as driving currently commercialized product, products, this provides a strong foundation for our future as we look to bring to market a rich pipeline with new product launches planned almost every year through to 2030. Finally, and looking ahead to the full year, we remain on track to deliver INR 1 billion revenue for Biocon Biologics, mid-teen constant currency growth in Syngene, and an improved second half performance in generics. That concludes my opening remarks, and before I hand over the floor to questions, let me end by wishing everybody a very happy Diwali and all the very best for the year ahead... May I now turn the floor over to questions?
Thank you, Peter. We'll wait for the question queue to assemble. Ladies and gentlemen, please use the raise hand icon in the Zoom application, and then we will take the questions once the queue assembled. First question for this evening is from Dhaval Bhalodia. Please go ahead.
Good morning, everyone. Myself, Dhaval Bhalodia. I had a question regarding the U.S. biosimilar industry landscape. Currently, there is three largest PBM and specialty pharmacy holder majority share in the biologic product market. And our brand, Hulio, is one of the formulary in one of these largest PBM. However, this particular PBM is planning to introduce their own biosimilar brand in collaboration with Sandoz. So given this competitive landscape, I'm curious to understand the strategic approach we are adopting. Could you please shed some light on the what strategy we are implementing to navigate this competitive environment, and how we anticipate the sale of our Hulio brand to fare in the year 2024?
Uh, Shrehaas-
Sh- Oh.
Shreehas, do you want to take that?
Yeah. Thanks, Peter. I think, thank you, Dhaval, for the question, and I think, between Matt and me, we'll respond to your question. Maybe, Matt, you can start, and then I can add to this. Do you want to go ahead?
Yeah. Yeah, sure, Shreehas. Thank you. Thanks for the question. I think, you know, as we continue to watch the evolvement in this whole biosimilar industry as it relates to adalimumab and our Hulio product, this is a significant, what I would call, change, but one in which it's not the full portion of everything that we see in the market and the opportunities. This is a position in which a large payer has taken, but it's still playing out. What we've seen is them announcing this. We have not seen the large player now start looking at all formularies, both commercial and non-commercial formularies. So we continue to look at our biologics and our platform in regards to the total market itself as it relates to adalimumab and Hulio, and we're seeing good progression in what we call low-cost sensitive payers.
Just because they've announced this on the commercial side, doesn't limit us to playing in the rest of the full market. So we're gonna continue to watch how this plays out with the company you mentioned and the third party that they have set up. We have been in active discussions with them. We do understand exactly how this market is shaping up, and I think, you know, in my opinion, you know, it's something that we need to continue to focus on, but not something that would limit us to the rest of the market, as we go through this. And remember, biosimilars, it's just not an exclusive. Most of the payers will be looking at this, we believe, going forward in a situation where they won't have just one biosimilar.
Once the Humira, when the payers decide what they're going to do and release this, we believe the market will reopen up again, and there'll be opportunities no matter what certain payers or partnerships are looking like. So we remain positive for the future and how we're looking at our products, especially our Hulio product. So I'll turn it over to you, Shreehas, for some additional comments.
Thanks, Matt. I think the only point I'll add to what Matt said was, You know, these are strategies that payers will come up with, and I think we will respond to these as, as the market progresses. Just want to point out that, you know, the payer that you referred to also has formularies outside of commercial, and, those would be in the managed Medicare space and the Medicaid space, and you've seen, our product being listed on those. So you will see outside of the particular collaboration that you pointed out, payers, the same payer making selections depending on, on what prioritizes their decisions on those formularies. So as Matt said, we've, you know, we are aware of these things, and we, we remain, in connection and contact with customers, engaged in seeing how these decisions are made.
Okay. Thank you, and my second question is, you know, there is a couple of concerns recently come out due to the current environment. Firstly, with, you know, the 85% of the price erosion on the biosimilar product compared to the brand, in case of the Hulio, in case of the Humira, and secondly, the higher interest cost on our current debt in the prevailing high interest rate environment. So I just want to check, I know this is a current, you know, just recently came up. This was not the case at the time of the Viatris acquisition. But I just want to check whether this negative factor was adequately considered or factored in into the decision-making process?
During the Viatris acquisition, it will be helpful to know if our current debt has a, whether fixed or floating, interest rate structure, and if we hedge our interest rate exposure for our debt. Thank you.
Thank you for the question there. I think perhaps, again, Shreehas, if you'd like to address the first question, and maybe Sid, you can address the question on interest rates. Or Chini.
Yeah, I think Chini can address that as well.
Yeah. I think, I think the, the question, Dhaval, is very valid. I think from the time we've announced the, the Viatris acquisition back in February of 2022, obviously things have changed and interest rates have revised overall. As, Peter mentioned, even in his opening remarks, we've, we've seen, adalimumab behave differently in terms of the slower ramp-up than expected. We had obviously guided for a, for a slower 2023, with, with pick-up beginning in 2024 and 2025 being the, the real opportunity. Things will probably play out, in that manner, but 2023 has, been slower than what we had initially planned. So to that extent, you're right, things have moved a little bit, but the opportunity remains intact. And, you know, this moves by a couple of quarters into 2024.
To your question on what these interest rates have been and how they've moved, I'll defer to Chini. Chini, do you want to take that up?
Yeah. Hi, so as far as the the INR 1.2 billion loan is concerned, we've kept, one third open to allow for early prepayment, one third has been hedged, and, one third is open for the interest rate movements. So that's how we manage the one-
It provides for enough flexibility to accommodate for, for how we're moving forward, Dhaval, if that's what you're looking for.
Okay, that's it only from my side. Thank you so much.
Thanks, Dhaval.
Thank you, Dhaval. The next question is from Yash Tanna.
Yeah, good evening, and thank you for the opportunity. So my question, sir, I'm trying to understand the PBT number for Biocon Biologics. So last quarter, we said that there is a one-off $15 million expense due to the legacy contracts. And before that... I mean, if I add that back, and in Q4, I read about INR 150 crore. So I'm not able to understand, even with the 35%-35 crore increase Q1Q, the number on the PBT side.
Again, I think that's Shreehas, Chini?
Chini, why don't we explain this to Yash, and then we'll walk him through? I think we've had a healthy performance on the business and how the PBT is impacted. Maybe you can explain that too.
Yash, hi. As you've noticed that there's been a strong improvement in our core EBITDA performance for the quarter. We've moved from INR 513 crores to INR 660 crores, but the EBITDA is kind of flat at the 450 mark, 457 in Q1 and 453 in Q2, and that's largely because Q1 had the benefit of licensing income, which played out, and that helped improve the core EBITDA. Sorry, improved the EBITDA for the quarter. This quarter, you've seen strong sales performance, no licensing income, or meaningful licensing income, and EBITDA is back up at 450 despite no licensing income, and as I indicated earlier, the strong performance at the core EBITDA line.
When you go to the PBT line, we've kind of moved from +24 to -15, and that's largely because of the increased amortization cost consequent to the launch of Hulio, or biosimilar adalimumab, in the U.S. So there, there's a net step-up or increase in the amortization charge.
So got it. And my second question is relating to the growth, at least in the near- to midterm, with the observations on the Malaysian facility. As part, I believe, is not... Are we anticipating this for FY 2024? And if not, how are we planning to grow above the INR 1 billion base that we had targeted, we had set out, you know, at the start of the year?
Let me respond to that, Yash. I think from an aspart perspective, I think the development has been positive in terms of the engagements that we've had with the agency, and we will be in active engagement with the FDA early next year. So once we have clarity on what exactly it is that they expect you to do, we'll be able to give you more color in terms of when that opportunity realizes, whether it is early 2024 or it's later. But I think it's important to see what the growth drivers were when we began the year. We exited Q four of last fiscal with an exit run rate of $1 billion, and we were looking to grow that business with the growth drivers, particularly driven from the commercial products.
As you heard in Peter's opening remarks, almost all, or not almost, all of our products have grown in market share over last year. One of the most reassuring things is in the major geographies, both in the U.S. and in Europe now, we're seeing very strong growth in all our commercial products. Now, as U.S. still moves on with this, approvals with the FDA, one of the important things for commercial products is we've got seven products approved in the E.U. adalimumab and has done well in Germany and France, but we have a lot of headroom in the other products where we could go grow from the base that we've got.
We are starting to see that with bevacizumab, which has moved from a low base of 1%-7%, and we are starting to see that in other products as well. So clearly there's an opportunity to grow from the base that we exited last year, last fiscal to where we are now. We also do look forward to the opportunities with Hulio. Like Matt said, we haven't given up on that, or it's not a closed opportunity. We believe that this is an opportunity which is intact, but just shifted at this point in time. And as payers and as markets outside of the commercial channels open up, we will look at that also driving growth into calendar 2024.
That's where we are in terms of where we see this growing from the base that we exited last fiscal.
Yeah, sir. Got it. Thank you, and happy Diwali to you and the team, and the rest of-
Happy Diwali, Yash.
Thank you, Yash. We'll take the next question from Surya Patra.
Yeah. Hi, thank you for this opportunity. My first question is about the like-to-like growth that we would be seeing in the biosimilars operation. So in fact, the specific question is that we have seen a kind of a good ramp-up and good adoption of our biosimilar by payers in the recent period, and also the integration has provided some kind of additional control in the U.S. market. And simultaneously, we have seen some kind of or incremental pricing pressure for the biosimilar. So, net-net, if you see, we have Y-over-Y basis has almost doubled in terms of reportable revenues in the biosimilar business. But is it possible to share what is the like-to-like growth that we would have seen?
The extension to that is that, see, whether we are doing better in the non-U.S. market compared to the U.S. market at the current juncture, if you can share that.
Shreehas, I think again to you.
Yeah. Thanks, Peter. Surya, I think one of the things we've not done so far is give product-by-product details, so that's something that we've not disclosed at this point. I think one of the things when we look at better over last year, and we see almost all geographies performing better over last year, we've put out the major geographies in the U.S. and E.U. by product, and we've shown that growth in terms of how we've performed over last year. So I think it's been a very clear pattern that in the U.S., all products have performed well, and we are seeing that growth across the E.U. as well. So we are seeing that move up. Price erosion, as I've said, even in the past, is an outcome of competition.
So that's something that you will continue to see, and that's where volume growth is extremely important. So these market shares have come at a stage where we've looked at preserving ASP, so we haven't gone chasing market share at a crazy ASP. So we've been able to conserve, preserve value and build those market shares in a very steady, measured manner. So it's grown over time in a profitable way as we've offset the price erosion that's happened over the course of time. But to go and look at every product by geography, that I don't think we've shared those details so far.
Okay. In fact, the basic point I was trying to draw from my question is that, see, the spend on the U.S. biosimilar is obviously significantly higher compared to the emerging market. Basically, we are utilizing the same dossier for the other market, non-U.S. market. And the non-U.S. market, it seems, grows better or growing better than the U.S. market at the current juncture because of branded play and all that. So my sense is that, see, unless until we cover off the R&D spend, the incremental R&D spend after the integration of Viatris operation, what we have seen from the incremental U.S . revenue, we may not see much ramp-up in the margin or improvement in the margin profile.
So, so that is why I was trying to assess that, whether the current performance has been supported by the non-U.S. market, which is branded business growing relatively better compared to U.S. But, U.S. possibly will see the ramp-up only after the commercialization of the pipeline products.
Chini, do you have any additional color for Surya in terms of the margin profile by regions?
... so hi, Surya. We don't disclose margin by geography or product, right?
Mm-hmm. Sure, sir. Okay. My next question is on the large Medicare or payers that we have seen as a or the large Medicare payers that those who have adopted our products in the recent period. So with that, what is the kind of theoretical market share that we can see for our glargine as well as Herceptin?
Matt, you wanna go ahead with that?
Yeah, I'll take it, Shreehas, and then I'll pass it over. Look, as I think what this demonstrates is good demand for Biocon Biologics products. As we bring on these new payers, certainly we're looking for that market share increase, and we anticipate that. But right now to say exact numbers, it's early. All we know is what Peter had highlighted in his opening comments, is that we have won two significant payers that will be starting at the first of the year or have started. That will be a nice contributor to our insulin franchise. And then also we continue to see additional traction, and this is what we're excited about in North America, additional traction in our trastuzumab, in our pegfilgrastim, as we continue to win those payer awards, as well as adding new ones.
And then we've also seen, as Peter said in his opening comments, some nice wins in regards to our adalimumab, and our Hulio. So, to say exactly what those market shares will be, it would be hard to project, but we are anticipating that growth because the additional wins and the demand for our products across the board, whether that be in our insulin, or oncology, or even in our immunology. So I think it shows and demonstrates, as Peter and Shreehas shared, as we're cutting over, and we say this, and I've said it before, biosimilars is not just what we do, it's all we do. And I think that's really the focus that allows us to continue to see this progression, as well as our, our manufacturing and our, vertical integration to continue to compete.
Lastly, I'll say across our products, and why I think we continue to see this uptake, is that. But we are dedicated to the market, and I think that shows in our, our value to our customers, and also the ability to maintain the products that are needed for patients that rely on all of our products, and our commitment to the market, both in North America and Europe. As you can see, market share continues to increase there.
Sure, sir. Just with your permission, one last question from my side related to the regulatory compliance-related development. So, my sense is that, Insulin a s part, possibly, was the low-hanging fruit on that, on that regulatory compliance or advancement front. And subsequently, we were thinking about, the bevacizumab linked to the Bangalore site. So is it fair to believe, so with the CRL, what we have achieved for, now Malaysia site, so the development of, this bevacizumab, and the related, the plant-related development regulatory in the Bangalore site will only happen post Malaysia plant's clearance, or both are happening parallelly?
Surya, let me respond to that question. The aspart CRL is an independent issue from the current status that we have with the FDA at this point in time. The aspart CRL is an outcome of the inspection that we received in August, September of last year. They had already accepted our CAPA. They found it to be adequate, and they had written to us that they would need to verify the completeness and the effectiveness of those CAPAs when they do that in a follow-on pre-approval inspection. That inspection was to happen before the goal date in October of this year. That pre-approval inspection was not scheduled. So the aspart PAI is linked to us having that inspection yet, which has not been scheduled.
The status in Malaysia is linked to the surveillance GMP inspection, which was scheduled for products approved and commercial, which is not related to aspart at all. So these are two de-linked activities. As far as India site is concerned, we continue to supply the commercial products. The pre-approval inspection is for bevacizumab, for additional capacity and for trastuzumab. So those are different requirements, and at this point we await that inspection, which is scheduled for Q4 of this fiscal year. Obviously, whenever you have a regulatory observation, you wanna make sure that globally, all your sites and all your networks benefit from whatever actions you take.
And our quality team, led by Michael, and then our Chief Operating Officer, Rhonda, who is also on the call, we've put in place a very comprehensive program to make sure that we've, you know, implemented these practices so that the agency continues to see the upgrades that we've made on our quality maturity journey that we've been on. Clearly, it's a step up in terms of what we are looking to do and that's a process that's a part of our business, which we continue to invest in.
Sure, sir. Thank you. Wish you happy Diwali to entire team of
Happy Diwali, Surya. Thanks, Surya. We have the next question from Jainil Shah from JM Financial. Please go ahead.
Yeah, hi. Thank you for the opportunity. My first question is on aflibercept. So is there an update on the litigation? And if all goes well, when is the earliest we can launch this product?
So, Jainil, as we've said in the past, the litigation update is what... is as we've shared in the past. We do not have any further update. The trial's completed, and at this point, we await the decision from the judge to see what the next steps could be. That's where we are on aflibercept. In terms of launch date, I think at this point, since we are in an IP litigation, it wouldn't be fair to comment on what that would be.
Sure. And, at the time of acquisition, you know, there were certain deferred payments to be made in FY25. So, is it linked to any milestone, you know, and what is the quantum payable, and how do you plan to pay that?
Those are not, I don't think there's any milestone. Jenny, is there any milestone linked to this? Not to my knowledge, Jainil.
Okay, so but it is payable in FY25, right?
That's correct. Right, Chini?
Yes, it is payable in FY2025.
We'll be paying from our internal accruals, or we'll be raising money for that?
A combination. We are looking at... We have different ways to pay down the deferred payments. Lastly, yes, internal growth, and we could have some other fund flows that we planned for.
Okay, and just on the filing status, so we were supposed to file Stelara by this year and denosumab by next year, and Humira interchangeability, I think that... So, how are the trials progressing?
Jainil, just happy to share with you that we are on track for both ustekinumab, which is in, you know, before the end of this year, and for Denosumab also end of next year. That stays on track, and we have passed the trial, but we, of course, talk about it only once the applications are made and the dossiers are submitted and accepted by the agency.
Okay. Okay, that's all from my side. Thank you, and happy Diwali.
Happy Diwali.
Thanks, Jainil. We'll do the next question from Nithya Balasubramanian from Bernstein.
Yeah, hi. Thank you. First question is on Glargine. You had alluded to two new payers now adding Glargine in their formulary. If you can tell us what number of commercial lives, or I'm assuming it's commercial, but what number of lives that it represents?
Matt?
Yeah, I would say at this point. So hopefully you can hear me. Sorry. This point, this remains confidential along these lines. But I can tell you they are large payers. And why it remains confidential, we're still on track to be able to announce this, but at this point, we are not disclosing that.
Understood. You had spoken about managed care organization, where you were expecting to see better traction in Insulin Glargine this year. However, if I look at the data, I'm actually seeing slight slippage in market share. So what's happening there? Why haven't we seen the progress?
Yeah. Shreehas, would you like me to answer?
Yeah, yeah. I think please go ahead.
Okay, yeah. Some of this, the IQVIA data, there are some large payers, closed-door networks that don't report. So you're seeing some quarter-over-quarter buying patterns, but you're not seeing the full picture because of the way folks in IQVIA report or don't report. But we continue to, as Shreehas said, maintain that mid to high teens, and I think with the new, large payers coming on board, that definitely will be, something we'll be able to hit that target with.
Understood.
Just one thing to add, Nithya, to what Matt said, when you have a closed door network like Peter referred to also in his opening remarks, when they do not report in the IQVIA data, one of the good things about this is it's an exclusive channel, which also sees a very high degree of conversion to the brand. So it straightaway comes to Semglee or insulin glargine with an over 90%-95% conversion in a quarter's period.
How do you see the adoption of GLP-1s impacting insulin volumes? Do you see that as a mid- to long-term threat?
We see this as at this stage, and again, this is just to be qualified appropriately, but we see this as complementary treatments, things that will coexist over a period of time. I will defer to Peter. Peter, if you would want to give an overarching view on GLP-1s and insulins together.
... Sure. So I think you state the nature of the answer, Shreehas. I mean, I think it- they would be complementary. Insulins would be obviously for type 1 diabetes, GLPs would be more to the type 2, and of course, beyond that, the weight loss opportunity. And this talks to, you know, the investments that we're making in the generics business in building a peptides, a peptides technology capability and capacity to take advantage of, of what could be a, you know, very, very strategic peptide opportunity with GLPs at the center. Analyst estimates of what the loss of exclusivity for GLPs could look like over the next 10 years, you know, hover around the $100 billion mark. So that's a very big opportunity for the generics business and very complementary to the, to the biologics business with insulins.
Got it. Thanks. If I may, any updates on your interchangeability study for adalimumab? When might you be expected to file the product? And for Stelara, again, would you again be going after interchangeability? We know that a peer now has an interchangeable designation for their biosimilar.
So two things on the adalimumab study, we've already said it's underway, and we should have the outcome to discuss in the coming calendar. So that's one. On the Stelara piece, we feel quite confident on the interchangeability discussions. We're starting to see that come through. The agency believes that that can happen, and we feel very strongly about that from our product—for our product as well.
Sorry, Shreehas, do you mean an interchangeability designation for Stelara without doing a switching study, or?
We don't want to disclose the specifics of our strategy, but we feel good about our how our interchangeability should work.
Thank you so much.
Thanks, Nithya.
Thanks, Nithya. The next question is from Shyam Srinivasan from Goldman Sachs. Please go ahead.
Yeah, good evening and thank you for taking my question. Just want to reflect on the last 12 months from a Biocon biosimilar perspective. I remember when we were talking about the acquisition or even in the first quarter of the acquisition, we were talking about this $1 billion run rate. We are talking about the same $1 billion run rate for this fiscal year as well. So just want to understand, you know, has some of those pieces... Which are the pieces that we think that did not materialize for us to see growth over a 12 or 15 month period time, right? And underlying profitability for the business, I remember at that time, was roughly 25%, is what was, you know, kind of thought of, and I'm including R&D, not looking at core EBITDA or something.
Net debt to EBITDA at that time, you know, it probably looks like now closer to between 4 and 5. What are the plans for us? If you remember, as cash flows gets generated, we wanted to pay down debt. So just the overall piece of doing the transaction at that point of time and 12 months out, how does it look? And which are the pieces that are probably not working, maybe which are working?
Let me take it, Peter. Is it okay?
Yeah, sure. Please do, Shreehas. I'll comment at the end.
Okay. Shyam, I think that's a very fair question in terms of where it is, and I think you're right. Some things have worked well for us, and some things have not gone well, and it's not just gone well for us, probably not gone well even from an industry perspective, so more like a class effect. From what's gone well, we've talked about it, where we've seen that off the base that we came off from last quarter, last year, we've been able to do what's in our direct control, where we've been able to gain market share as we've transitioned that business sooner than what was there. So we are more in control of our destiny than before.
So in terms of value, more than 50% of the value of the business is now transitioned to Biocon Biologics. So these are all the good things. That's allowed us to gain control of it, so it... You know, things like what surprised us and what didn't go well in terms of the legacy contracts that led to rebates, which we had to accommodate in the P&L, some of it, which hit us in a big way, you know, from a quarterly perspective. We have a better control on that now. The broad drivers that we looked at have certainly differed. So what didn't work very well has been the Hulio launch, which we expected on July 1.
We were able to launch the product as planned, but from an entire industry segment itself, none of the biosimilars have been able to win market share in 2023. And I think that's something that's to be looked at because the opportunity moves and remains intact at this point in time. We have some work to do because we've taken over the business post the launch, but we will. You know, our teams are working and engaging with customers to see how we can get into formularies, because that's an area that we haven't been successful yet. So clearly, we are doing that for the commercial formulary. As part is something that has indeed surprised us, the pre-approval inspection. We believe that, you know, we have a very strong quality management system in place.
But of course, you know, given that we've got approvals in almost every other geography, but we still have to win the confidence of the FDA. And at this point, that's the process, and we are just gonna be working to see how we can win credibility with the agency. We have approvals with EMA, with Health Canada, TGA, Anvisa, Cofepris, you name the agency. But I think what's not gone well for us yet is that we haven't been able to get across the line from an FDA perspective. And that's something that I can tell you our entire leadership is focused on, and we should see success sooner than later because of the efforts that we are putting in and the discussions we've had.
So I think if you do a full SWOT of it, there are things that have gone in our favor, and there are things that we could have done better. But the important thing is that these are opportunities which have shifted, and we believe they're still to be realized in the coming quarters. But I'll pause, and I'll see, Peter, if you wanted to add something to that.
Sure. Thank you. Thank you, Shreehas. I think the only thing that I would add, because I think you've given a very comprehensive answer, is the progress made in the transition. As Shreehas alluded to, we have not yet got our hands around 50% of the business, only just in the United States. So it's not steady state. We're going through a complex transition, you know, and we're doing it in an accelerated, shortened period of time, and there are a lot of things that we need to do. Shreehas has alluded to very many of them, and again, I think the entire team is focused on, you know, navigating through the transition, getting our hands around the full business, and our hands on the steering wheel.
You know, once that integration is complete, and we've consolidated, as I think many of the questions have provided pointers to, we see a very healthy growth future ahead, driven, you know, by the market share gains where we've got into commercial products. Of course, those are offset to some extent by price declines, but by a very healthy pipeline that once we get through the FDA discussions, you know, all go well for the future. So it's not, I think, the right way to look at this as steady state at this point in time. I think another two quarters, and we'll really have gone through the integration and consolidated, and then, you know, then we'll be steady state and have the kind of trajectory that we're looking at.
Got it. Very helpful. Just a second question to Siddharth on the generic piece, right? I think API business, I think you mentioned there were pricing pressures, muted growth, and I think one product where you have taken, you know, a pause, perhaps. So just want to understand what's happening there. We earlier had some guidance for generics, but looks like we've not mentioned anything except that H2 will be better. So just that color on both API and formulations. Thank you.
Thanks, Shyam. Yes, we've had a H1 growth of 9% in the generics business. In quarter two specifically, we have also seen a very good growth on the formulations business, which continues to perform well. We continue to gain market share on statins, and we also expect to launch couple of new products, and that's what is gonna probably drive the growth in the coming quarters. Of course, it will take some time before we see this INR 200 crore odd number per quarter that we are clocking in the formulations business go up significantly. But on the API business, the reasons you mentioned, we have one of the plants which underwent a planned shutdown.
And hence, there were capacities that we could not manufacture, and we expect to cater to that customers' demand in the coming quarters. So it's just moved to the next quarter. But at a macro level, when I look at, there has been an impact seen as a result of the pricing pressure that some of our customers have faced, and either they have asked for much lower prices, which we are not able to cater to those demands at that price. Or our customers, in certain cases, have lost the business that they had with their customers, their end customers, and which has led to lower offtake. Directionally, I do not see a huge change for the kind of products we have, the genericized products, in the coming quarters.
Of course, a lot would depend on, as and when we launch, new products, especially the peptides in the coming quarters, and that's where we'll see a growth, kicking in to that mid-teens, level in FY 2025. So for H2, just to reiterate, H2 will be better than H1. We will see a steady performance of formulations at the level at, which we had in H1, which is, around INR 400 crores. And, H2, API business should pick up compared to H1, but on an overall basis, the guidance that I'd given last year of mid-teens, might be more titrated down to low teens to high single digit.
Got it. Thank you, and all the best.
Thank you.
Thank you, Shyam. We have the next question from Mr. Rumel Dahiya, a retail investor.
Okay. Thank you, Mr. Paliwal, for giving me this opportunity. I speak as a, an investor, a long-term investor in Biocon, and with a large number of concerns to share. I have been on social media, I've been interacting with the chairperson. She has very kindly been replying also from time to time, also with your investor relations team, but I thought the concerns are still not addressed. I thought they would have been addressed in the presentation by Mr. Bains, but no, they were not. So I thought, let me just bring them up front, and I have a couple of questions. I'm sure you'll accommodate me for this.
My first question is: Has there been a, an analysis, the cost-benefit analysis or, let's say, the opportunity cost that we have lost because of poor inspection record? ... particularly in our Johor Bahru plant. Has there been anybody held responsible, for that loss that has been caused because of poor things like a sterile scissors not being there or an exhaust pipe being blocked, and things of this nature? If we take pride in quality consciousness and quality readiness, how can we have such things and repeatedly, you know, multiple observations, then CRLs, then official action indicated, how can that happen, and what are we going to do about it, and whom are you going to hold accountable for this?
What is the total loss that, that would have occurred, opportunity, cost that we would had to incur? That's my first question.
I'll happily start that. Others may want to contribute. Thank you very much for the question, Mr. Dahiya. Let me start by saying that the Biocon Group has, you know, a long, a strong, and a very proud track record in terms of quality and compliance. You know, you can see that in very, very many dimensions, including some of the comments made on the call today with FDA approvals. You know, and of course, the CRL in Malaysia. Shreehas has explained the background to that and the current situation in which we are actively in a very focused manner engaged with the agency. Shreehas has said that the next meeting is scheduled for the Q4 this fiscal year, and we can update then.
I think it's also entirely reasonable to pull the lens out a little bit and look at the wider picture and, you know, the FDA, you know, in terms of, you know, post-COVID activity, the bar on quality has been lifted a little bit and, you know, we do not have any fundamental issues there. We've described the nature of the findings in Malaysia to you related to aspart in this call. You know, and we're working expeditiously to resolve them. Again, as Shreehas has alluded to, any learnings that we gain from this exercise will be cross-fertilized across the entire network.
And we will be looking at doing that to ensure that, you know, going forward, we're ready, you know, and compliant across the lessons learned from there in all our sites. And to further build, I think, the very proud reputation that the company has in terms of agency inspections. Shreehas, do you want to add anything to that?
Yeah. Thanks, Peter, and thank you, Mr. Dahiya, for your question and for your long-term association with the company and your, your belief in us. I think we share your frustration to a large degree because there are, you know, situations where despite efforts, we are not able to move past the FDA hurdle, like I said, at this point in time. We've had an exceptional track record with global regulators, so I just want to balance that, and this is not to justify that, that we haven't been able to work across the FDA right now. There is, of course, a heightened expectation of the biologics facility and, and picking out a particular observation and discussing it would be a little challenging. But I think it's important to note that we've been able to work with, with global regulators.
We've been able to show them what are the developments and improvements that we've made across our facilities, across the network. But as I said, it is not enough at this point in time. There is effort ongoing to make sure that we can work with the expectations that FDA has, and I'm very confident that the team that we've put together, and we have them on the call, and the effort that have gone into putting this together will yield results and success. So it is a matter of time, I believe, when we will start seeing the results of this efforts that are going in.
Thank you. That's helpful, and I'm glad that there is an acceptance of the need to do more. Now, my second question is about a deep discomfort as far as the shareholders are concerned. Now, Mr. Tambe mentioned about more control of destiny of his own country, but probably the shareholders of Biocon do not have the control over their own destiny. People like me have lost 40% of their investments over the last 4 year, 3 years, and sit on large huge losses because the share prices haven't moved up. I remember in one of the meetings last time, chairperson said, "We can do nothing about the share prices," but must...
But I think it's a listed company, and the management has to be responsible for it and answerable to the shareholders for bringing down their value. We seem to be the only people whose concerns are not being taken care of. Every time I hear a strong growth, very strong growth in EBITDA, but what matters and what investors are more concerned about is net profit, and net profitability percentages have been low. Even in this quarter, where one expected things would be better, the net profit is only 4.6% of the revenue, which is low by industry standards and for all the companies of this nature. May I know if the agony of the shareholders concerns the management at all?
If yes, what are they going to do about it, and when are things likely to improve going forward?
Sure, let me start again, Mr. Dahiya. And certainly, you know, the management are concerned about shareholders' concerns and the feedback that we get. Our job is to build our business, you know, in a profitable manner, and to play into the market, and the markets will ultimately set price. But that's not an abrogation of responsibility. I can assure you that everyone in the Biocon Group is working extremely hard to drive the profitable growth in the business models that we're engaging in. I mean, quite clearly, we are in the midst of a transformational initiative with the biologics business, and I think, as I alluded to before, we're not yet at steady state.
Quite clearly, the research services business has continued to grow very profitably, as has the generics business. But when you take on an undertaking of this global nature and transform the business into very much a top-tier global integrated operation, it does take a little bit of time. We, you know, we've accelerated that timeline, and we're making very good progress. And of course, we recognize that we have a lot more to do, and you've put your finger on several of those areas. And I think Shreehas has very comprehensively described what we're looking at, what we're doing, and the timelines on the regulatory front, as he has on many other aspects of drivers for growth. So we are extremely focused on building a profitable and growing company.
Right now, we're in the middle of this transformational shift, and the steady state, as I alluded to, I think is a couple of quarters away.
Thank you. Although it does, does provide hardly any comfort, and the ball is, you know, just kicked to the next quarters. But that notwithstanding, simple things like foreign exchange losses. I mean, the company hedges foreign exchange, but four out of five times at least, it makes losses in foreign exchange this thing. Is there a lack of understanding of the dynamics of foreign exchange, or is there less of effort being put into that, or what? That's number one part of this particular question. And second part is that, are we not... What are we doing to control our expenditure? I think our expenditure is too much. There's, so as a result of which, obviously the net profit will go down.
Are we, have we bitten more than what we can chew? Have you taken on far too many things on which a lot of expenditure is incurred simultaneously without consolidating? Is there any thought about managing the finances? Is there any plan, please?
Maybe, Shreehas, you, or Chini, or Sid, do you want to address the hedging question? And then we can come back and talk a little bit more about cost control.
Yeah, and I think we should, we should look at that data in terms of the foreign exchange. Maybe I think it's best to look at the, the data with Indranil and Chini and maybe see what, what is the reference at a BL level. Overall, what is the comment that Mr. Dahiya has, and, and what is the reference? So we can, we can address it with facts, and then we'll, of course, certainly address your comment, Mr. Dahiya, in terms of, how are we looking at, looking at this, and what kind of a transformation we are on. Because when you are looking at these kind of transformational opportunities, which are once in a lifetime, I think it does take a bit of time to get this ongoing and, and firing in the way you want.
So, yes, I can understand that there is frustration along the way, so I completely appreciate what you're trying to say. But let's get the facts first on the Forex, and then we will address that concern, if it's okay with you.
Thank you. Thank you. Thank you.
Indranil, Chini, do you have anything on the Forex, and then we can move on?
Yeah, I think we need to present that as a group. Combine the gain or loss, and we will clarify that.
We can also do this with you, Mr. Dahiya, offline with our finance team, just so that you get the facts proper, because we can look at data and then see where we are on the policy. I can tell you our finance team looked at this very closely, and we will look at the concern that you've raised and see how best we can respond to your concern.
Thank you. I was just saying that, you know, if you're hedging, you're spending some money on hedging, and still making losses, is it worthwhile hedging thereafter? We might as well not do hedging, and then bear the profit or loss, whatever it comes. So why are we suffering losses on both counts, paying fees and yet suffering losses? That was my main concern.
Thank you.
So obviously... Yeah.
Sorry, I'll just clarify. So really, the... I mean, whatever-
... gain losses includes the hedging cost. We've largely seen gains play out, but there are some things on our books, particularly the Goldman Sachs investment, which keeps getting retranslated. These are products you can't hedge, and that reflects as a book loss, but that's not a cash loss. Largely, we've seen robust forex management and gains through flowing through from-
Largely as a-
Management.
And maybe Sibaji can also add up, because there is also a large component of loss coming from Syngene. So Sibaji, maybe you can give a context there.
Sure, Sid, thank you. So Mr. Dahiya, we hedge to manage risk forward. So if you look at Syngene's hedging losses and gains, in 2020, financial year 2021 and 2022, we had hedging gains simply because the rupee did not depreciate and the banks were giving higher forward rates. The case has been different in the last two years, in 2022, 2023, and now in 2024 also. Because, for example, in Syngene, our hedge rate was 81, the current rate is 83, so we are booking hedge losses. However, why we hedge? Because it's a policy, because we want to bring certainty and don't want to leave our top line and the profit number exposed to uncertainties coming out of the forex market, we do that.
Having said that, you know, whenever we have a hedge loss, we have an equivalent higher revenue over there. Because if our... For example, the rate is 83, our revenues will be higher, so we'll book a higher gain in forex on the revenue line, and we have a hedge loss on the expense line. The profit impact is neutral. So it's, it's more optics, and it brings certainty to the, you know, financials, and that's why the hedging policy is over there. So I can assure you there is generally very little profit impact and cash impact coming out of hedging, but it provides firmness and certainty.
Thank you.
Yeah, and also at a group level, just to, I think one of your questions was that do we pay a cost to get these hedges? So as a group policy, directionally, I think most of our hedges are range forwards or forwards, where we do not pay cash to acquire these contracts. And just at a H1 level, just for the three businesses, the generics business is largely forex neutral this year so far. And like Chini mentioned, there is a certain instrument in Biocon Biologics. It is getting notionally restated, and there is no cash loss, but there is a restatement effect, which is why you see that loss. And the third aspect is on the research business, which my colleague, Sibaji just clarified.
Mm-hmm. Thank you. Thank you. And, now the question about, are we, how do we manage the expenditures, and what are we doing about that so that our net profits increase?
I think this is a normal question in terms of how we are looking to control costs, and I think that is signified in terms of... We can respond to this as three different companies as well. But let me respond on Biocon Biologics to you, Mr. Dahiya. And I think one of the key indicators of how the business is performing and the health of the business, if you leave aside all these exceptionals that we've been discussing, is to look at the core performance of the business or what we're looking at as core EBITDA, where you've taken out all of these one-time things and said, "Okay, if this is what I'm operating, what is the gross profit I make?
What are the staff costs that are included, and what is it that I see as my margins?" And if you look at that, that's always been in that mid-thirties, regardless of where we've been, and that is clearly very, very, comfortable. It is better than most other peers in the Indian pharma group. Now, this is not to signal to say that we are, you know, the best, but this is something we've been consistent about, and we have been staying to that, extent. We do invest a significant portion of our revenues in R&D because, as you know, that's our lifeline, as, as Kiran has been saying all along, and that is something that, is higher than most of our industry peers, which has been usually around that 6%-7% range. We've been, in the past, up to, 14% as well.
So we've capped that at around 11%-12%. So that brings our EBITDA margins, which is, at this transformational stage, a reflection of what the business is doing, even if you take the investments in R&D, which is at that mid-20s. Now, that's remained more or less consistent and a true reflection really of the health of the business, as long as you accommodate for these transformational costs, which will be more transitionary in nature until you settle down and get to a steady state that we were talking about. We do expect to get to a steady state. There are, of course, these pluses and minuses that I was responding to earlier when Shyam asked that question.
We are fully aware of what has worked, what hasn't worked, and we will make sure that you know, these things even out over time. But I think at this stage, you know, like you've been patient and long-standing with us, I think what is really required is to have that patience to play this out, and we believe that you know, going forward, this will play out the way we're all expecting it to.
Fine. My final question then, you know-
Mr. Dahiya, if I may, because we're running out. We're on the hour and about to close. We'd be very happy to pick this, to pick your questions up offline.
Okay.
If, with your permission, I propose that we do that. I hope we've answered some of your questions. You clearly have more. We'd be happy to pick them up offline, as I've said. With your permission, I'll then hand over to Saurabh to close the call.
Thank you, Peter. Ladies and gentlemen, this was the last question. For any further clarifications or questions, you know, please do get in touch with us. And Nikunj and I are available to answer any of the follow-ups which may have been missed today. With this, I wish you all a happy Dhanteras, and wish you all a very happy Diwali, and a prosperous New Year ahead. Have a good night.