Good morning, everyone. I am Saurabh Paliwal from Biocon's Investor Relations team, and I would like to welcome you to Biocon's Earnings Call for the First Quarter ended June 30, 2023. I would like to indicate that all the participants will be in a listen-only mode, and there'll be an opportunity to ask questions after the opening remarks conclude. Should you need to raise, ask a question, please raise your hand on the Reactions tab in your Zoom application. We will call out your name and unmute your line to enable you to ask a 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 also like to bring to your attention that this conference call is being recorded.
The recording will be available on our website within a day, and the transcript will be made available subsequently. Today, to discuss this quarter's business performance, as well as the future outlook for the company, we have Dr. Kiran Mazumdar-Shaw, our Executive Chairperson, and other senior leaders from different businesses, including Biocon Generics, Biocon Biologics, and Syngene. I would like to also take this opportunity to remind everyone related to the safe harbor for this 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 us. With this, I would like to turn the call over to our Chairperson for opening remarks. Over to you, Kiran.
Thank you, Saurabh. Good morning, everyone. I welcome you to this earnings call for Q1 of FY 2024. Let me start by saying that the Biocon Group has started fiscal year 2024 with a strong revenue-driven first quarter across all our businesses. Before I dive into financials and business performance, I want to reiterate our commitment to delivering on Biocon's mission of enabling global health equity to affordable access to essential and life-saving therapeutics. We engage on this mission primarily through the three principal business growth pillars of our enterprise model: Biocon Generics, Biocon Biologics, and Syngene.
While each of these pillars are at different stages of business maturity, we are very carefully and deliberately planning, building, and executing on strategies to ensure that each pillar is well-positioned for differentiated and competitive growth to build true global leadership in the years ahead. As we do this, we keep at the forefront of our commitment to our four principal stakeholder groups: the patients we seek to serve, our people, whose talent and capability aim to deliver our products and services, our investors, for whom we strive to repay their risk and patience with superior returns, and our business partners who support and collaborate with us to achieve our mission. Let me now begin the business review and turn to our three pillars, the first being Biocon Generics.
In line with our business priorities, our generics business continues to focus on growing its product pipeline, creating and capturing value through vertical integration, with a clear focus on innovation and digital transformation. Building on its widely recognized strengths in fermentation-based products, we are adding capacities and capabilities in new growth areas such as peptides, high-potent drugs, and injectables. We will also continue to direct our efforts towards forging strategic partnerships to accelerate our expansion into key global markets. I would now like to turn to Biocon Biologics, which is the next and biggest growth pillar for Biocon. We are building a unique, fully integrated global biosimilars platform driven by the depth and breadth of our portfolio, R&D excellence, cost-effective manufacturing, global quality standards, flexible supply chains, and growing global commercial muscle. We have embarked on a transformational journey with the acquisition of Viatris' biosimilars business.
To remind you, this strategic acquisition creates a unique, fully integrated lab-to-market and globally scaled biosimilars enterprise. It is well-positioned to compete in the exponentially growing biosimilars market. In a recent market review by McKinsey, the global biosimilars market is predicted to quadruple by 2030, benefiting from more than $200 billion, I repeat, $200 billion of originator biologics losing exclusivity. In its new, fully integrated form, with eight in the market and 12 pipeline products totaling to a portfolio of 20 assets, Biocon Biologics has become a truly global player and is well-positioned to fully capitalize on the enormous future opportunity. Having closed the acquisition in November last year, fiscal 2024 will see us complete the operational and organizational integration of Viatris' biosimilars business into Biocon Biologics, establishing the foundation of our fully integrated global biosimilars model.
I'm pleased to report that we are making good progress against our plan, and I would like to provide you with some key updates. To ensure business continuity, we had entered into a transition services agreement with Viatris to provide ongoing operational services for a period of two years to complete the integration in a phased manner. I am happy to report that we are tracking well ahead of this plan. On July 1, 2023, we successfully integrated over 70 countries in emerging markets into Biocon Biologics. This, this successful integration, coupled with a strong leadership team, gives us the confidence to accelerate the transition of North America and Europe, and I can report that we'll integrate all markets into Biocon Biologics before the end of this fiscal. Coming to Syngene, the third growth pillar for Biocon.
With almost 30 years of experience, Syngene provides end-to-end therapeutic discovery capabilities, including differentiated research technologies and platforms across many disciplines, disease areas, and therapeutic modalities. Its extensive and experience and deep expertise have made it a trusted partner to many leading multinational startups and medium-sized enterprises, as well as nonprofit institutions and academic institutions. With an established track record in discovery, research, and development for small and large molecules, Syngene is now building its capabilities in commercial manufacturing, offering clients a one-stop shop capability from drug discovery to commercial manufacturing for clients and more balanced model for investors. In fact, Syngene is now the premier and leading company offering biologics manufacturing capabilities. Coming to our full FY 2023 integrated report. Having reviewed our operational pillars, I would now like to turn to Biocon's ongoing commitment to ESG. Biocon's ESG agenda continues to advance.
We engage with our 16,500 strong workforce to make progress towards our ESG focus goals, including building a diverse, equitable, and inclusive workplace. In FY 2023, we evolved our core growth strategy to integrate environmental, social, and governance factors. Embedding sustainability into our corporate culture and day-to-day operations enabled us to continue developing life-saving medicines in an environmentally and socially responsible manner. Having closed an eventful FY 2023 on the business as well as the sustainability front, we are proud to have released Biocon's maiden GRI, GRI-aligned integrated report. I'm also happy to share that Biocon Biologics has also separately released its first integrated report. I would encourage you to read the reports and provide us with your feedback. Before I discuss the business performance, I would like to start with a board update.
I am pleased to welcome Rekha Mehrotra Menon and Nicholas Robert Haggar as independent directors on the board of Biocon. Rekha is a leading industry voice on technology-fueled innovation and socioeconomic progress. She was a key player in Accenture's growth for nearly 20 years, including over seven years as Chair of Accenture in India. She was the first woman to serve as the Chair of NASSCOM. Nicholas has over 30 years of experience in leading and building pharmaceutical and healthcare enterprises. He has held the position of Chairman of Zentiva, CEO of Insud Pharma, President of Medicines for Europe, and Regional Director, Sandoz. He's currently the CEO and founder of HealthCubed Limited and a non-executive director of Zentiva. I will now present the key financial highlights for Q1 FY 2024.
At the group level, total revenue for the quarter was up 59% year-on-year to INR 3,516 crore. The biosimilars segment revenue more than doubled as compared to the previous year on the back of the acquisition of Viatris' biosimilars business. Research services grew 25%, while Generics had a healthy growth of 15%. Core EBITDA, which is the EBITDA before R&D, licensing income, Forex, and mark-to-market movement on investments, grew by 42% to INR 936 crore, representing a healthy core operating margin of 28%. R&D spends for Q1 stood at INR 315 crore, which is an increase of INR 117 crore as compared to last year, and corresponds to 12% of revenues ex Syngene.
EBITDA for the quarter was up 69% at INR 808 crores versus INR 478 crores last year. EBITDA margins stood at 23%, as compared to 22% last year. Depreciation, amortization, and interest increased by INR 353 crores over last year. This is primarily related to the biosimilars business acquisition cost. Consequently, profit before tax and exceptional items stood at INR 184 crores, and net profit for the quarter stood at INR 101 crores. I will now discuss the business performance in a segmental manner, and I will start with generics. The generics segment reported an operating revenue of INR 700 crores for the quarter, a growth of 15% over last or over the same period last fiscal.
Profit before tax for the quarter stood at INR 64 crore, with a PBT margin at 9%. Revenue growth for the quarter was primarily driven by our U.S. generic formulations business, where we have benefited from additional contracts that were secured last quarter. There were also new product launches in key ex-U.S. markets. On the API side, we continue to see traction with our immunosuppressant APIs portfolio. We received one product approval from the U.S. FDA, a tentative approval for lenalidomide capsules indicated for the treatment of multiple myeloma. On the regulatory front, we had a successful outcome of a GMP and pre-approval inspection of the oral solid dosage facility in Bengaluru, which concluded in June with zero observations. This is in addition to the successful outcome of the Hyderabad API facility's pre-approval inspection in May, reported last quarter.
Both inspections are now officially closed by the FDA, we have received EIRs for them with a no action indicated status. Coming to investments being made for capacity expansion, during the quarter, we broke ground on a new injectable facility at Biocon Park in Bengaluru. This facility will cater to the long-term sterile fill and finish requirements for our generics business. Work has also commenced on the expansion of our peptide and fermentation capacity expansion in Bengaluru. These expansions are expected to be completed over the next two years. Coming to biosimilars. First of all, I'm pleased to report that the market share performance of our key commercial products has significantly improved across key markets. This positions us well as we complete the transition and build on the positive momentum.
Looking first at the U.S. market, we continue to see increasing demand for one of our key commercial products, Semglee, our branded biosimilar insulin glargine, and unbranded biosimilar insulin glargine, translating to a market share of 12% in June versus 8% last year. The higher NRX or new prescription shares of over 15% demonstrate strong ongoing adoption of our product. We conti.nue to add significant new customers in the U.S. with exclusive status for our insulin glargine, which includes a large managed care network from July 2023, and more recently, another large payer, effective January 2024. Ogivri, our biosimilar trastuzumab in the U.S., has also steadily increased market share to 11% in June versus 9% last year, with growth coming from new customer contracts.
Fulphila, our biosimilar pegfilgrastim, continues to gain market share in the U.S., capturing 16% share against 8% last year. The weekly market share in July has crossed 19%. It is now the biosimilar market leader, demonstrating physician and payer confidence. We launched Hulio, our biosimilar adalimumab, in the U.S. on first July, representing a key milestone for the business. The U.S. adalimumab market comprises several channels, including commercial Medicare, Medicaid, Veterans Affairs, Department of Defense, and many more, with each requiring different strategies for success. Biosimilar uptake for adalimumab has been more gradual than expected across the industry. Our dual pricing strategy is expected to enable Biocon Biologics to participate in all these segments, and we are in active discussion with relevant stakeholders. On the European front, we continue to see strong demand for our products in major markets.
Our adalimumab garnered market share of over 18% and 10% in Germany and France, respectively. We have also seen a strong uptake of Abevmy or our biosimilar bevacizumab in Europe, with market share at 5% in May versus 1% last year. Biocon Biologics' emerging markets business continues to see strong uptake of our flagship products, recombinant human insulin, insulin glargine, and trastuzumab. The integration of 70 countries from Viatris' biosimilar business allows us to expand our reach and portfolio within emerging markets. Coming to financials, these increases in market share and the consolidation of the Viatris biosimilar revenues have led to Q1 revenues doubling over last year.
On a sequential basis, we have seen revenues remain largely flat at INR 2,015 crore due to phasing of the tender business in emerging markets and a one-off impact of rebates in the U.S. for our pegfilgrastim. This has translated to a core EBITDA of INR 513 crore, with margins at 28%. It is important to note that in the case of pegfilgrastim in the U.S., the revenue and margin for the quarter were impacted due to higher rebates based on legacy contracts with select customers, which will normalize in the coming quarters. Post-transition, by the end of this fiscal, core EBITDA margins are expected to return to the mid-thirties. EBITDA margin, consequently for the quarter, was at 23%, with R&D investments at 13% of revenues. PBT before exceptions stand at INR 24 crore.
Moving on to regulatory issues, Yesafili, our aflibercept, was the first biosimilar to receive a positive opinion from EMA's CHMP, recommending approval. We are also the first company to receive conditional approval for aflibercept biosimilar from Health Canada, with the final approval linked to ongoing litigation. The clinical trials for biosimilar ustekinumab and denosumab are progressing well, and we are on track for filing by the end of 2023 and 2024, respectively. In July, US FDA conducted two CGMP inspection of our Malaysia facility, issuing six observations for drug substance and drug product units and two observations for the delivery device units. The inspectors did not identify any systemic non-compliance. We have submitted a comprehensive CAPA plan to the agency and expect to resolve this expeditiously. We continue to strengthen our global leadership team as we transition the operations of the acquired business.
We have appointed industry veterans, Rhonda Duffy, as the Chief Operating Officer and David Gibson as Global Head of Business Development. These appointments are in line with our commitment towards operational excellence and focus on new growth opportunities. In summary, we are pleased to see strong uptake in market shares of our products across geographies with a line of sight on multiple growth catalysts. Our business continues to grow with better performance of our products in existing markets, such as glargine in the U.S., geographic expansion of our commercial products such as adalimumab, aspart, and bevacizumab, regulatory advancements of our pipeline assets such as aflibercept, ustekinumab, and denosumab. Finally, coming to Syngene, revenue from operations grew 25% to INR 808 crore over last year. Reported EBITDA was up 25% to INR 235 crore, with margins at 28%.
Profit before tax was at INR 123 crore, up 33% over last year. The performance during the 1st quarter was strong, led by development and manufacturing services, and well supported by the discovery services and dedicated centers. During the quarter, Syngene took important steps as part of its strategic priorities. Earlier this month, it announced a deal to acquire a multimodal biologics plant from Stelis that added an additional 20,000 liters of installed manufacturing capacity, along with a high-speed fill and finish facility. The proposed acquisition strengthens Syngene's position as a leading biologics contract manufacturer and development service provider. Finally, Syngene completed the acquisition of additional land in Hyderabad to support the long-term growth ambitions of its research services divisions.
Together, these actions reflect meaningful progress on Syngene's strategy to strangle both research and manufacturing services and give it the capacity it needs for the next stage of growth. In conclusion, I believe the Biocon group of companies has delivered a strong business performance this quarter, essentially a very robust revenue-led performance, and established clear pathways for exciting new growth inflections. Building on their shared heritage in Biocon's manufacturing and scientific excellence, Biocon Biologics, Biocon Generics, and Syngene are now emerging as uniquely differentiated world-class players in the global biotechnology products and services markets. I firmly believe that these are very exciting times for the Biocon group, and I look forward to reporting our progress in the coming quarters.
With this, I would like to open the floor to questions. Thank you.
Thank you, Kiran. Ladies and gentlemen, to ask a question, please click on the Raise Hand icon at the bottom of the Zoom application. We will call out your name once we see a queue assembled.
Thank you.
We'll start with the first question from Damayanti Kerai from HSBC. Please go ahead.
Hello. Hi, good morning. My first question is understanding the pricing environment for biosimilars a bit better. Ma'am mentioned about Fulphila seeing impact of higher rebates, rebates during the quarter. Can you talk a bit about how we are seeing pricing for other biosimilars, say, Semglee or Ogivri? In terms of prescription, we have seen recovery in all the products. When I compare the reported sales, excluding licensing income, we have seen sequential moderation. I want to understand the pricing part better.
Matt, Shreehas, over to you.
Thanks, Kiran. You start. I can jump in after you're done. Go ahead, Matt.
Yeah, the pricing that we're seeing in discount trends, they've not been uniform. When you think about your medical side or your pharmacy benefit side, they vary by product and therapeutic area and by channel, and there's differences in between each one of those. Taking a similarity that you would see in one product and comparing to another, does not necessarily translate. I think what Kiran had said in the beginning, particularly around pegfilgrastim, there is a change in how we're looking at the rebates that were legacy. What we're seeing on the other products, we are seeing very active growth and good growth in those other channels, like Semglee, trastuzumab, et cetera, et cetera.
Specifically on insulin, what we have been hearing, I guess, there has been a lot of focus on lowering the prices from all the stakeholders in the industry. From Semglee's perspective, did you see any such pricing pressure coming in?
You're... I, I believe you're talking about the WACs that are changing in 1/1 of 2024. As we're seeing it right now, no, there's not that pressure. Remember, on the Semglee, particularly, there's two channels. You have your branded and your unbranded, and we're playing in both of those. There's a mixed variation on those rebates between low WAC and high WAC, but the mix continues to be in a positive manner that we're seeing with our insulin glargine and Semglee.
Okay, thanks, thanks for your response. My second and last question is, post-Hulio launch, can you update us on, what you're hearing from, payers or what has been, their response, and any discussion which is currently ongoing for, prices, et cetera? How do you see, your share moving up in this, particular market?
Thank you very much for the question. These are very, very early days, and the payers' landscape is still developing. I think what's important that you've seen in early announcements, there's. Let me remind you, the overall size of the pie is extremely large, with the multiple opportunities we have and then the coexisting of multiple players. Just these early announcements that you've seen come out on the commercial side, and as Kiran said in her open remarks, there's multiple channels. Not only do you have commercial, but you have Medicaid, you have Medicare, you have government, you have TPOs, you have IDNs. These multiple channels allow us to continue to participate in many aspects as this market is continuing to develop, which is slower. The overall market is seeing the payers taking their time.
I think what's important to remember, the attributes of our products and our relationships and sales force, we're very strong with our product and our two-click Hulio product, which, lots of our, feedback from payers as well as physicians like. We do have a strong sales force. We are supporting hub services and patient services, and so we're in active discussions with all the payers as this market continues to develop, which you'll see over the next, through 2023 and into 2024, as this market continues to develop, and we're well positioned to participate.
Okay. Thanks, Matt. I'll get back in the queue.
Thank you.
Thanks, Damayanti. We'll take the next question from Harith Ahamed from Avendus Spark. Please go ahead.
Hi, good morning. Hope I'm audible.
Yes.
Thanks for the opportunity. I, my first question is, is on the core EBITDA margins that you've disclosed for Biocon Biologics. It's at 28% this quarter. I see that it was around 39% last quarter. There's a sharp decline, and you called out the timing of some tender business supplies in EMs and higher rebates for pegfilgrastim. If you can quantify this impact of these, that'll be helpful, because it's a fairly sharp decline.
Yes. I think, Shreehas, you should explain this.
Yeah. Thanks, Kiran. Thanks, Harith, for that question. As Kiran said in our opening remarks, we've seen strong growth in our products overall in North America, all our products, and we've shown the year-on-year growth that we've had. Clearly the, the business is trending in the right direction, and our market shares are growing. We've had a situation with one product where we've had these managed care customer, where the legacy Viatris contracts that we had, had a higher rebate, which was offered to select customers. That was in the region of around $15 million. That has been since reset, and most of those resets happened beginning of this current quarter, which is starting July.
What we are seeing from here on, is that we expect these to basically recover over the coming quarters, and we see business recovering to normal margins over the course of this as we take these contracts again. Important to note, Harit, is that July onwards, we've seen pegfilgrastim market share grow to 19%, and we are now the largest biosimilar pegfilgrastim or the largest by pegfilgrastim in the US market. Clearly that is a good recovery from where we are, and we expect this to get better over the coming quarters. Harit, does that answer your question?
Yes, yes. I was on mute. That's helpful. My second question, if you can share the breakup between regulated markets and emerging markets for Biocon Biologics revenues for the quarter.
Sure, that breakdown we can, we can offer. Chini, do you have that breakdown overall between advanced markets? In the past, Harit, we've given a guidance that it's been roughly around that 70-30 mark. We can, I can share. Chini, what's the breakdown for this we can share with Harit?
Harith, morning, it's 75% advanced markets, 25% emerging markets.
Okay, a follow-up, the licensing income that you booked for the quarter, that is related to the regulated market geography or the emerging market segment? One more question around the licensing income. This, this figure of INR 167 crore, those, this income pertains to deals that were signed during the quarter, or these are deals that we've, you know, partnered in the past, and the revenue booking is happening now?
Yeah, Harith, as we said, even in, in previous quarters, we've had this discussion, in-licensing and out-licensing is a part of our business. We will see this as we decide on our portfolio. We will in-license product, and you will see that happen in a particular quarter. You will see out-licensing of certain assets that we may not see particularly wanting to develop or in a particular geography. We will see that happen across a certain quarter. We saw some of that happening this quarter, and that was the recognition of that INR 167 that you talked about. You will see this happen in a particular quarter. May not necessarily happen in every quarter.
As these opportunities mature, or we make a strategic decision on what, and how we want to pursue our portfolio, you will see these, occurring over and, around every quarter.
It's a mix of, you know, the emerging markets and regulated markets, that's the way to look at the number?
Yeah, I mean, it could be emerging markets, it could be in an advanced market, depending on how we are looking to license the portfolio and commercialize it going forward.
All right, thanks, Shreehas. That's all from my side.
Thanks, Harit. We'll take the next question from Surya Patra from PhillipCapital. Please go ahead.
Yeah, thanks for this opportunity. First, a clarification about this INR 15 million charge relating to the pegfilgrastim. Is it fair to believe that this is a charge because of the new contract and relating to the 12-month period, and depending upon the pricing situation and the rebate situation and competition, a similar charge on the product would come in the subsequent period or subsequent contract? That is one. Also, whether this kind of enhanced rebate and charge can come relating to other product like Herceptin and all that?
Yeah, let me respond to you, Surya, on this. I think what we have clarified even in the opening remarks and now, this is about the past. There are legacy contracts that were signed in the past, as Viatris is running the business today. What we realized is that certain select customers in the managed care segment had been offered higher rebates. This is for business that is in the past, and those rebates are then passed on, or discounts are passed on as they book the revenues, and those had to be reset. What we've done now, is we've reset these contracts. Going forward, that's why you will not see those things come in, and hence we are saying that in the coming quarters, these things will get better.
Big part of this is, has changed starting July 1, hence we are seeing this improve right away.
Okay.
Does that clarify that part, Surya?
Yes, certainly, sir. It will not be related. Means, we'll not see any kind of charge like this relating to other products?
We are not aware of any charge at this point on any other product. This is related to pegfilgrastim, and we've corrected that charge and reset those contracts, and going forward, we will be seeing those, you know, margins coming back to normals.
Okay. Now, sir, just one another clarification I wanted to have. This, when we talk about this market share for any product in the US, let's say, is it the total prescription that is really written or it is the prescription that is filled?
Matt, do you want to respond to Surya's question?
Yeah. Sorry, Shreehas, I, I couldn't really understand the question. I apologize.
Let me add to, to that, Surya, a little bit, and then see if, Matt, you want to add on.
Okay.
Surya, these are the market shares that are reported today for, say, Glargine, since you asked about it. Our market share between the branded and the unbranded products, we have proved them, and that is at a little under 12% today, and that's what we are saying has grown. The new prescriptions are trending at around 15%, so that's a, that's a leading indicator of where things are going. Kiran did mention in her opening remarks that we also have onboarded a large closed door, you know, managed care customer. Those numbers don't get necessarily accounted for in the market shares that are reported, and we believe that's also a very strong indicator in terms of how our Glargine will drive growth in, in the... starting from the current quarter moving forward.
Matt, if you want to add anything further to that.
No, I think you covered it, Shreehas. I apologize I couldn't hear that question. Thank you.
My question was, so recent studies indicate that the prescription generated or written for any product in the biosimilars are meaningfully different than the prescription filled by the patient actually. That is why, in terms of the market share, when we are mentioning, so is it based on prescription written or based on prescription filled?
I, I think, I think you're asking about what we can see as current prescriptions and then what's being written new. If I'm hearing you right, so new prescriptions give you an indication for refills or continued prescriptions in the future. I think what you're looking at, particularly in Semglee or insulin glargine, if you're looking at the IQVIA data, you're going to see the trends of the prescriptions that are being filled, and then you can look at the new RXs. Normally, the indication of new RXs will give you a good read on how the trends of the prescriptions are going to continue to grow. As Shreehas said, when we, when we've won this large closed network in July, those do not report in IQVIA, and that can vary your market share and understanding.
What we're seeing is, is growth, not only in new RXs, but growth in our partners, which will be closed doors networks as well as payers. Hopefully that answered your question. If not, I will, I will try again.
Yeah, yeah, sure.
I think, Surya, to just simplify it, I think the 12% is the prescriptions filled and the NRXs are prescriptions written.
Okay. Okay. Sure, ma'am.
15% is the trending towards how much extra is being written. 12% is really indicating how much is filled.
Oh, that is really helpful. My third question is relating to the, the integration thing, what you mentioned in the opening remarks, ma'am, about the Viatris strategies and its integration in the US, and that is likely to be completed by second quarter. What practical changes are we mean by this? Because we know that the marketing arrangement is, or the marketing support we are currently taking from the Viatris for next kind of 1.5 years or so more. This integration will bring what kind of a benefit, let's say, in US?
Maybe, Shreehas, you would like to take that question?
Yes. Thanks, Kiran. I think, Surya, as you know, that we had signed up with, with Viatris for a two-year transition services agreement. As you rightly said, the commercial, team that Viatris had is a, is a part of that, deal that we had, which will be coming over from Viatris to us. The reason we had, you know, signed up this two-year transition services agreement is because there were functions that we needed to get ready outside of commercial, so that we can actually run a successful business in the US, and we had given ourselves a two-year window to be ready with that infrastructure. Today, we feel confident having moved over 70 markets in the emerging market space.
We are feeling quite confident with the leadership that we have put in under Matt's leadership and the other leaders that we've brought on board in the US and in North America and Canada. We believe that we're in a good place to move the business over to be led by Biocon Biologics by the end of this quarter. We also have a very good alignment with the team that's coming over from Viatris to us. That's why we believe that we can accelerate this transition, bringing greater focus to the business that will now be only focused on the biosimilars, which should then benefit what we are trying to achieve as a company.
Sure. Yeah. Thank you, sir. Thanks, sir. Thanks a lot.
Thank you, Surya. We'll take the next question from Neha Manpuria from Bank of America. Please go ahead.
Yeah, thanks for taking my question. My first question is on... I think in the presentation you made a comment about core margins, you know, going back to the mid-30s by the end of FY 2024. Based on your comment that, you know, the one-off that we saw in rebates is, you know, whatever, it should normalize, any reason for why we should see a more gradual improvement in core margins, versus a full year guidance of mid-30 to high 30 margins?
Let me, Kiran, you're on mute.
Neha, I said before the end of the quarter, end of the fiscal. I think we expect to see it sooner, but, you know, basically, I'm guiding for the fact that we have reset the rebates and hope that over the coming quarters, we get back to normalcy, as Shreehas mentioned.
Apologies, I was in, mute. ma'am, just to understand this clearly, we're still holding our mid-thirties guidance for FY 2024, the core margin guidance that we've given for biosimilars?
Yes.
Understood. My second question is on Hulio. Shreehas, based on the, you know, contracts that have been announced so far, and given that there's been a more gradual uptake, you know, in the entire Adali biosimilar market, you know, what's your sense on, you know, when we can get clarity on how peers think about allocating volumes? You know, when, when would we get a better sense on, you know, what the opportunity could be for Biocon?
Yeah. Thanks, Neha, for that question. As Matt answered earlier, the opportunity is very sizable. The Humira opportunity in the U.S. is a very sizable opportunity. We believe that, you know, this decision-making will happen over the course of this calendar year, so we should have that clarity on how things will evolve. There are commercial plans, commercial health plans, which will make a decision, which is about, I would say, a part of that business, a large part of the U.S. market. Outside of that, as, as, Matt and Kiran in our opening remarks, addressed, that there are several other pieces of the market which would be the managed care market, the, the Medicare market.
I think basically, while these decisions will be made during the course of the year, you will see, and we've said this in the past as well, that business will track forward from 2023, leading up to 2024, and you will see most of these things really consolidate towards 2025. I think this is what we've heard from all other industry players as well, and that opportunity remains intact. Even from our perspective, we're very well positioned to, to realize that opportunity, given the, the kind of product that we've developed, the success that we ride on in the back of what we've achieved in Europe, and the kind of team that we've got, which is very well aligned to commercialize Hulio in the US, with the product and the, the patient service programs that we've got.
We feel quite confident here, Neha, as the decisions get made over the course of the few months ahead of us.
In your assessment, Shreehas, what portion of the market, you know, the commercial contracts that have been announced that we have seen, you know, I, I assume this would be for the next 12, 12 months. What portion of the market do you think is already locked in and probably not available for us?
There are two things that I want to draw your attention to, and I'll respond two things separately. One is, if you look at the overall US market, the commercial space is roughly 50%-
between the, the large players, and then there are a, a bunch of other smaller players as well. What we've seen made public so far are two, commercial players, two large commercial players who've made announcements. If you, if you notice their announcement, they've said that they continue to, look at these as, as an evolving thing.
It's not like this is it, and no one else will be, looked at. We don't see this as a, as a definitive position. What we see is what is announced at this point, is a set of, of players who've been, enrolled on two health plans, and we see most of the other things still evolving as we go around. That's why the commentary that, that Kiran had.
Understood.
decisions are still gradual.
Understood. Thank you so much, Shreehas.
Thank you, Neha. We'll take the next question from Shyam Srinivasan from Goldman Sachs. Please go ahead.
Good morning, thank you for taking my question. Just the first one on the sequential run rate for the Biocon biosimilar segment, how should we look at this as we go forward? We were expecting a faster ramp-up. I know you talked about the reset in pegfilgrastim, as well as the tender business change, but how should we look at it as we move through the quarters? A related question is just on some of the market shares that we had aspirations for, especially Semglee, both branded and unbranded. You talked about the fact that MCOs don't get added in, I get that, but the high teens market share that we were talking about earlier, is that something that's still that we can certainly do? That's the first set of questions.
Shyam, let me answer that by saying that, yes, the $50 million impact that we've seen in the rebate on Pegfilgrastim has also impacted our top line, as it has impacted our core EBITDA and EBITDA as well. It has basically run through our financials. Yes, that is the reason why you have not seen an uptick in terms of increased market share. The second thing is, of course, we are very, you know, encouraged and confident that our performance in the US and many, many other markets is showing good growth, and we expect that to translate into both revenue and, you know, bottom-line growth. That's what I would say at this point in time, but maybe, Shreehas, you'd like to add something?
Sure. Thanks, Kiran. I think, Shyam, to your question, two things I would say, one is, maybe also partly responding to what Neha had said, if you were to look at that 15 million, and if you, if, if you add that back even in the current numbers, I think like Kiran said, to the revenues and to the core EBITDA, the quality of earnings is already at that mid-thirties. The business that is trending today is already quite strong, both in terms of the, of the revenues that we, we're looking at, and in terms of the margins that it's trending towards.
I think where the, where the aspect of, of the uptick is also expected is in the emerging market side, which, as you know, a large part of that business is dependent on tenders, and, and as Kiran also alluded to in our opening remarks, some of this is gonna be different from quarter to quarter. As you see those tenders realize and, and effect, you will see those, you know, move between quarters. Otherwise, the emerging markets business has done well, but the advanced market business has really been driving that growth, and we see that in place.
Your second question, which was related to Semglee, I think the closed-door managed care market, that customer, we certainly add a huge muscle to that number, because that's a single supplier situation, which means there is no other competitor. We are seeing a very high degree of conversion from the incumbent to us, so we expect to see that driving growth for us. We also see that driving market share. Outside of this, Kiran also referred to another large commercial player. This is the managed care player, but there is also a large commercial player who signed us on. Some of this will sign up towards the beginning of calendar year 2024, which will then drive growth for us in the last quarter of this fiscal, Shyam.
Sure. Is there a change to the market share guidance on Semglee? I think that is where I was trying to arrive at.
I think, we're still tracking to that mid-teens that we had said, Shyam. I don't think we are moving from that just yet. There's no reason for us to do things differently.
Got it. Just going back to the opening remarks on Novo Nordisk and the gradual progress and expectations have been, or rather, actual has been slower than expectations in the ramp-up over 2023, 2024, 2025. Just want to understand your experience in Europe. You know, some of the numbers that you're sharing for Germany or, or France are pretty good numbers. Do you think that is something that over time gets replicated in the US, or you think the dynamics are very different? That was my second question.
Matt, would you like to respond, and then-
Yeah, yeah. Look, thank you for recognizing Europe as being very strong, and I agree with you. What we're seeing there is good, strong, steady growth. As we go through this integration, as Kiran talked about, and fully transitioning away from Viatris by the end of the year, I, I see that continue to grow. We are gonna have that 100% focus, and we'll be able to drive additional, Adali build off of a great base of what we're already doing in Germany and France and Belgium, and then taking that into expanding that focus into other European countries. We are very optimistic around maintaining that strong, steady growth in Europe and maintaining our lead positions within Europe, France, and then gaining traction in other countries within the European Union.
Helpful. Last question is for Siddhartha. Just on the generics business, I think 15% growth, if you can just help us disaggregate that into what, what is happening in API versus formulation. There's been lots of commentary around the generic pricing improving. I think you, in your press release, talked about new contract wins. Help us walk through that, please, Siddhartha. Thank you.
Sure, Shyam. We've seen many new contracts come in in the formulations business in the US. We have seen disruption in the US coming from other generic players. As a fully vertically integrated player, especially in the statins and immunosuppressant space, has led us to garner additional market share. I think, when you track the IMS for some of the products that we have in the market, it's doing very well. We are getting closer to between 30% and 40% market share in the statins. Soon we expect that we will be able to get additional market share for immunosuppressants.
The bulk of the growth is from formulations, but as I mentioned, that we've also seen a good traction of immunosuppressants API, which continues to be a focus area and a growth driver for us. As far as the pricing is concerned, I think there are mixed trends. We've seen the pricing pressure taper down. We have seen in, prices stabilize over the last few months, and we just hope that this trend continues, and at least that way, we are, we are able to grow sustainably.
Siddhartha, data point, just the split of generics into API and formulations. Thank you.
Yeah, formulations business actually touched INR 200 crore this quarter. Out of INR 700 crore, INR 200 crore is formulation, and a little over INR 400 crore is API, and the remaining is other income.
Thank you, and all the best.
Thank you.
Thank you, Shyam. We'll get the next question from Parsa Shah from Bernstein. Please go ahead.
Hi, this is Nitya from Bernstein. Quick one on glargine, if you can indicate what is the incremental lives covered that you can now address with the new payer, coverage wins that you've had?
Okay. As you said, could we talk about the lives?
Yes, incremental lives.
Yes.
that is now being covered with the new payer wins you've had in lodging.
Yeah, I, I... You know, as, as far as these are, are confidential right now from the standpoint of these closed door and the large payer, I think what we continue to say is that it's really about the market share. Number of lives, because we've seen that one of the closed door, if you're familiar with them, they will do pretty close to 90%, 95% conversion. As we get into the latter half of this year or the last half of our quarter in FY 2024, this is where the second payer will come on. We're anticipating there, we will also be exclusive. We'll start seeing additional pull-through. The number of lives do vary, that's why I didn't answer it directly. It's really about the revenue and pull-through, and we are exclusive on both of those contracts.
You'll see that pull through over a period of time, and the closed door will pull through already, and continue to grow as we go forward. Not trying to dodge your question, just that lives aren't particularly the indicator. It's really the pull-through with market share, and are you exclusive on these contracts?
Got it. I think I'll, I'll wait, wait for whenever you're comfortable talking about the payer.
Thank you. Thank you very much.
On Hulio, if you can let us know what is the status of your interchangeability study, when are you filing it, when should we expect an approval? BI should lose their exclusivity in July, so will you be ready by then?
I think, Nitya, thanks for that question. Let me respond to that. I think the interchangeability thing we, we are seeing is, is something that we will be. We are working on that study. We should be in a position to, to give you more details about when we'll have it. We won't have it in July, since you have a direct question there, but we will have that study in play, and as long as you have that information together, we believe it will work to our advantage.
Got it. One last one, if I may. On aflibercept, I understand there is a litigation that's ongoing between Biocon, Viatris, and Regeneron. Early August was when the closing arguments were supposed to be read. Can you give us an understanding of when you're expecting the judgment to come through?
As you know, we are in an ongoing litigation on that. you know, we feel as, you know, as that is undergoing right now, there's not a specific date which has been set out, and wouldn't be fair to, to comment anything further on it, but, but to say that we, we remain quite confident and we feel good about, how things have progressed.
Okay. Thank you.
Thank you, Nitya. We'll take the next question from Tarang Agrawal from Old Bridge Capital.
Hi, good morning. two questions from me. One, Chini, in terms of accounting, would there be any inter-segment sale between the Holdco and Biocon Biologics? If so, what would be the nature of these sales? Second, if you could give us the business-wise CapEx outlook for FY 2024 between generics, biologics, and Syngene. Thanks.
Tarang, most of the sales of Biocon Biologics is to third parties.
Mm-hmm.
INR 2,015 crore, largely third parties, with very little support services we provide to Biocon Limited or any of the other group companies. On the CapEx, I'll let Indranil take the group thing. BBL's CapEx projections for the year is $150 million, largely for the Malaysia expansion, as we're ramping up our insulin capacities.
I'll, I'll take it for the generics, and maybe Sibaji, you can talk for Syngene. Generics, we will be seeing close to $100 million CapEx for next year, between $80 million-$100 million.
Yeah. Thanks, Indranil. For Syngene, we'll be spending close to $85 million, and close to $50 million of that will be research business. The rest of it will be in development and manufacturing. Yeah.
Thank you.
Thank you, Tarang. We'll take the next question from Yash Tanna, from iThought Advisory. Go ahead.
Good morning. My first question was on biologics. If I see the capital employed, it has grown at a much, for the last two, three years, grown at a much faster rate versus the profitability, which has led to RFCs coming down for the BBL business. My question is, in the next two to three years, do we expect this trend to sort of reverse? Because I, I believe we are largely done with our expansions, and acquisitions, and profitability going ahead should support return ratios.
Yes, that is the intent, and that is what we are working towards.
Right. Do we have a target number in mind, ma'am, for the next, let's say, 3 years down the line, we have our internal benchmark set for the business?
You do know that we are in, you know, we are in the midst of the capacity expansion in Malaysia. As you know, you know, the, the, sort of payback on that will happen once it's commissioned. As you know, all these CapEx projects in the biologics business, is a multi-year kind of, you know, commissioning process. Obviously, we will start seeing the ROC reflected at a much healthier level, probably in about.
... in FY, in fiscal year, at the end of this fiscal year, FY 25 and beyond.
Yeah. Got it. That's helpful. On the insulin side, I believe since we are in a position now to offer higher rebates to the pharmacy benefit managers, have you seen any impact, benefit of that? Because the payer, the other innovator companies have reduced the prices, right?
I've not understood your question, but maybe, Sheila, if you understood it, you could answer.
Yeah. You know, I, I, I think, what Yash is referring to is the high WAC and the low WAC dual pricing strategy.
Right.
offers us the opportunity to do that. I'll let Matt respond to it, and then if there's anything more, I'll come back. Matt, would you want to respond to Yash's question?
Yeah, yeah, sure. Look, like I said before, it's a mixed play with the rebates. Look, I just wanna say this before we start on just the economics. I mean, we do provide additional value with our products, like Semglee or insulin glargine, but we will remain competitive. The rebates between the high and low, based on payer contracts, can vary. As we look at the mix, it's very important how we consider when we bid this process, what's of the branded Semglee and what's of the low WAC insulin glargine. We do see variations, and these variations are by pay, by payer, or PBM, or by customer. What I would say from a standpoint, we are in good COGS position to maintain and compete with competitors.
Also to point out, and lastly to remember, the WAC piece is just the list price, it's not the net. When you see these WACs lowering, there's all kinds of things that can go into this. In closing, Biocon Biologics maintains a good cost position, and this is why you're seeing that maintained growth and the growth, of that profitability.
Right. That's helpful. Finally, on the debt side, is there any target number we want to reach by the end of the financial year 2024?
We are basically looking at our debt covenants and seeing how we can basically align with that, and we will raise funds accordingly.
Sure. All right. Thank you, and best of luck.
Thank you, Yash. We'll take the next question, Vaseela Vasanamala from FSSA Investment Managers. Please go ahead.
Hi, thanks. Am I on, sir?
Yeah.
I wanted to ask a question on the facility inspections, in the biosimilars business. Just, you know-
Oh, Vaseela, we can't hear you properly. Can you repeat it?
Yeah, I'll come closer to the mic. I wanted to ask about the facility inspections in the biosimilars business. Just maybe could you help us understand why, you know, we're having another round of observations in Malaysia? Do we need to make more investments in people, the processes, et cetera? Then, yeah, just how are you thinking about this?
Yeah. Maybe I'll get our quality head, Michael Cutter to answer this question.
Yeah. Thank you very much, Kiran. Yeah, thank you very much for this question. I, I think it's a very important question, and I, I'm sure many people have this. The inspection that we had was in Malaysia, was a routine inspection. We've had our previous inspection some three years ago, and we had some observations, six observations for the drug substance, the drug product, and the laboratory, so it covered that as a scope. We had two observations for our devices, so there were two parts to the inspection. The nature of these observations were not systemic. There was no data integrity.
I think the way that I would characterize these as these observations were, they were really demonstrating that we are making good progress in this facility, so there were no upgrades to the facility. In any case, we had the expansion project going on there, which is current thinking with the best practices in the industry. There were no infrastructure changes that we needed to make out of this. These were mostly procedural. They were training of some of our support people. This was the nature of the inspection observations. To that extent, there was nothing that we intended to do in terms of structural modification to the facility. Does that answer the question okay?
Yes. I mean, the fact that, you know, our launches are getting delayed because, we're still waiting for the approvals of these facilities, is there more that needs to be done, to sort of accelerate that?
Let me answer that question, Vaseela. We have actually provided a CAPA plan, which has been accepted for those launch, you know, approvals. Of course, there are two approvals, as you know. One is for insulin aspart, and the other is for, I mean, the other one is for bevacizumab. The insulin aspart CAPA plan has already been accepted by USFDA, and we're hoping that that is adequate. You know, we remain engaged to make sure that this is our understanding. The second thing is, of course, as far as the bevacizumab, you know, approval is concerned, that is in India, and that also the CAPA, the CAPA has been given, the CRL response is also about to be given, hopefully that should also get resolved, hopefully very, very soon.
Beyond that, we can't really predict when it will happen. It's up to US FDA to really look at what we have provided them. We're hoping that the inspection in Malaysia will also further strengthen their, any, any concerns they have about approving Aspart. That's as best as we can hope for.
Thank you for that, Kiran. I think it summed it up very well. Masira, is that okay for you?
Yeah, that, that answers my question. Just one more question. What is our net debt today, or as of the latest quarter?
For the full company, Siddharth?
Can I answer that, Sid?
Yeah, yeah, please go ahead.
Yeah. Excluding the structured investments, we are at $1.2 billion net debt.
Got it. Thank you.
Thank you, Masira. We'll take the next question from Cyndrella Carvalho from JM Financial. Please go ahead.
Thanks for the opportunity. Just a little more clarification on Aspart and Bevacizumab approval. Beva, you mentioned that we got a CRL. Was it related with the plant only that we are responding?
Yes.
Can you please clarify?
Yes.
It was actually because of the facility in Bangalore. There were some, you know, observations. We have basically provided a CAPA plan and a CRL response. That's what I was referring to.
Okay. In terms of our Beva approval, do you see anything pending from our end apart from the facility?
No. There's never been ever any scientific concerns about any of our programs. As far as CMC and others are concerned, there's never been a question. In recent times, the only observations we've had in a pre-approval inspection is pertaining to the facilities, and that's what we've been addressing.
Yeah. On the aspart approval, do you think we would require a PAI sort of inspection again followed, or in your mind it's not necessary? In my mind it's not necessary, but I just need to clarify the same from you.
Well, that's what we also hope.
Yeah, that's, that's really helpful. Just to Siddharth, how do we see the generic growth, given that you alluded to, pricing being more stable in U.S.? How should we expect our overall growth trajectory from the generic side of our business?
We'll be guided for mid-teen growth this fiscal. We would, of course, see a better second half because some of our facilities which were commissioned last year, and we are kind of doing the validation at this state time. We expect additional supplies to start in from these facilities. These were brownfield capacity expansion, so does not necessarily need FDA to come and inspect as compared to the new greenfield facilities, which requires inspection and adds more time for commercialization. We also are looking at locking in additional business in the US on our formulation side, and launching few new products as we go along. We have already got few approvals, and I think this quarter itself, we have two new launches that are there.
should we look for a closer to a double-digit growth rather than a mid-teens, like a higher double-digit growth? Is that-
That's what we hope for, quite honestly, it's higher teens, I mean, the higher double-digit. The visibility that we have, as we stand in the fifth month of the fiscal, I think I'm confident on the mid-teens, but of course, we would see what we can do to get to the higher double-digit.
Thank you so much, and all the best, team.
Thank you. Thank you, Cyndrella Carvalho. We'll take the next question, which Vishal Manchanda from Systematix. Please go ahead.
Vishal, please go ahead.
Yeah, thanks for the opportunity. Hope I'm audible.
Yeah.
My question is on the generic business. On the peptide facility that's going to come up in the first half, can you guide how many filings you have on the peptide front? And if possible, the total market that we are addressing through these filings?
We have around 15 peptides at various stages of development, of which we have already filed liraglutide in the U.S., Europe, and many other markets, both the, the strengths, Victoza and Saxenda, and they are being reviewed by FDA as well as the European Agency. We, if you look at the overall peptides opportunity, even though these 15 molecules are addressing diabetes and weight loss and other indications, but just the weight loss and diabetes management market size is expected to be over $100 billion in the next 10 years or so. We definitely see this being a huge, huge growth driver for the generics business over the next decade or so.
The other filings will follow up. Liraglutide is done, and the others will follow up from there.
Yeah, that's right.
Okay. Second on the immunosuppressant facility, could you guide on the peak sales potential and the investments made there, and the facility at Vizag?
We have invested, close to INR 600 crore in that facility, and, we already have a significant capacity in Bangalore, so this was an add-on facility. We would be looking at locking in more customers, mainly in the emerging markets, where we also see a huge opportunity. Since our, capacities were locked in primarily for U.S. and few large markets, we were not able to address, these opportunities. We definitely think that we'll have a much bigger market share in markets like even China, where, we, we are looking at playing, addressing that, market, in the years to come.
In terms of revenue guidance, I think it'll be difficult to give right now, because we'll of course, be selling both the API as well as the formulations, which we'll be co- commercializing in these emerging markets.
The Vizag facility also houses a formulation facility?
No, the formulations would be done in Bangalore. We have only one formulation facility.
Okay.
-for potent, molecules.
Right. if you could just give guidance on the peak sales for the Vizag facility, the API business.
That's what I said, it'll be a little premature to give that. I think we expect the revenues to commence sometime in calendar second half of calendar 2024. We are, of course, in discussions with customers to lock in, and even with regulators, where we are gonna file from this facility. I think we'll have a better sense, I would say, sometime next year in terms of the sales. We of course have internal numbers, which I don't want to communicate at this stage.
Okay. Final one on aflibercept, whether we are seeking interchangeability on the product?
Yes, the, so Vishal, the aflibercept product will, we will be looking forward to that interchangeability.
Right. If interchangeability is granted, you might also be eligible for an exclusivity there?
Sorry, I didn't understand the question, Vishal.
Will you also be eligible for an exclusivity on aflibercept, considering that you are first to file?
The, under the, the, the regulatory interchangeability guidance itself, the first interchangeable product has an exclusivity of, of one year since that launch. You will have that. As an interchangeable product, you will have an exclusivity to claim interchangeability.
Got it. Understood. Thank you. That's all from my side.
Thanks, Vishal. The next question is from Nitin Agarwal, from DAM Capital. Please go ahead.
Hi, thanks. Sidharth, on the generic business, there are significant investments you're making in the plants as well as in the R&D. We talked about the 15% growth for, for this year, you know, from a growth revenue perspective, but if you can just do some sort of crystal gazing on where, I mean, how do you see this business over the next three to five years with the kind of investments we're making? What are we... You know, what's the big picture story in, on the generic business over here, given the fact that we started out in this business fairly late versus, maybe a lot of the other peers?
Let me answer your later question first, before I come to your second question. I think in, in terms of the overall big picture for the years to come, we continue to invest in our fermentation, which has been a core in what we have been doing as a differentiated offering for more than two decades, and we are building on to our portfolio in fermentation. That would continue to be one of our focus areas. The second is peptides. I think the opportunity that peptides offer, I mentioned sometime back, that over the next 10 years, we look at almost $100 billion addressable market. And again, this has been...
While many companies are attempting peptides, I think this is really about science, cutting-edge science, and we think that the capabilities and the experience that we have had in developing molecules like peptides, we do have a good head start, and we'll be able to play in this area very competitively in the years to come. Of course, we are looking at injectables as one of the focus areas, where we would continue to forward integrate some of these peptides, as well as the fermentation-based APIs into injectables, and offer thereby continuity of supply and for vertical integration to our customers.
We will, of course, continue to invest in our synthetic pipeline, both onco as well as non-onco, because whether it's in the statins basket, we, yes, I mean, you know that we have a leadership position in the statins globally, both in the API and now in formulations in the U.S. We would continue to invest selectively also in the, in the synthetic area. Now, combining all the core strategies which I mentioned, I, we, over a period of next four to five years, on a CAGR basis, I definitely expect a high double-digit growth, so somewhere between, let's say, 17%-20% kind of growth over a period of five years.
On fermentation, you know, on the business highlight, I understand, but on fermentation barring supplements, are there any large sub-segments you're focusing on, which can become bigger going forward?
See, there are two, two ways to look at it. In the existing capabilities that we have, we have not really worked on any new molecules over the last few years, and then we are working on a handful of molecules. I mean, let me remind you that fermentation universe is not very, very large. There's still a limited number of molecules. Some of the important molecules, which we did not previously develop, we are working on it now. The second aspect is we are also looking at other areas of fermentation, like protein fermentation, which we have never done in the past. There are, you know, there's prescription fermentation.
There are other areas of fermentation where we can expand, and we are evaluating where, where else, can we, you know, what else can we do, including things like microbial fermentation.
Right. Last one on this, from a, from an inflection perspective, at what stage do you see the profitability inflection in the business?
I think, I mean, of course, when I, you know, dissect our existing business, our fermentation business is quite profitable, but of course, it's being cannibalized by the synthetic products, which have been under pressure for the last few years. Now, from a inflection point, when we I think the margin expansion should happen again from peptides, both API as well as formulations. You know, majority of the profits are gonna be driven by few molecules. I think Copaxone or glatiramer acetate is one drug, which we are hoping that we'll be able to get the approval soon. Of course, the liraglutide and all. Now, these blockbuster launches are gonna drive the profitability to higher levels.
Thanks. Just last one, on what is the debt that is there on, the, the generic business, ex of what's in biologics?
Well, generics business is cash positive. I think it's almost INR 1,100-1,200 crore of cash. Actually, it's almost INR 1,000 crore. There'll be some dividend paid out immediately after the AGM. We'll still have INR 700-800 crore of cash in the system.
Just generally, on biologics, what would be the net debt situation right now?
It's just above $1.4 billion, Nitin.
This is taking the structured debt as equity or what recently done?
Excluding structured debt. This is the bank debt that we talk about.
Okay. Earlier you mentioned something about the covenants. That, do the covenants will require us, any specific fund infusion during the year, or next year?
We will calibrate it.
Okay. Okay. Thank you.
Thanks, Nitin. We'll take the next question from Ishita Jain from Ashika Stock Broking.
Hi, good morning. Thank you for taking my question. My question is on semaglutide, specifically. You know, Novo Nordisk, in their earnings commentary, mentioned shortage in the molecule, and the demand is pretty strong. Is there a CMO opportunity for us in semaglutide?
Well, that's for, of course, Novo to decide, if they want a CMO. There have been already a couple of filers in the U.S., so we were not amongst the first to file for semaglutide. We have it under development, we, of course, expect that we'll be on the 181 day for semaglutide. At this stage, honestly, you know, we have not explored being a CMO, because typically you'll know that when these innovators look at CMOs, they don't look at competitors. Since we do have a product, a generic product under development, it's unlikely that they will pick any generic player for... as a CMO. If, if at all, then they will bar the generic company to launch their own drugs.
I mean, Novo is already working with pure play CDMOs, or CMOs, to manufacture semaglutide, and I, I think that's what would be more apt for them, rather than looking at a generic company.
Got it. Can you talk about the strengths we have for semaglutide that we will be filing for?
Well, I think, it's the science, as I mentioned, that these are complex peptides. You know, to develop, characterize, these molecules does require a lot of understanding of these molecules and the amino acids, and how you kind of link them and synthesize these molecules, and that's the science.
We're asking about, the strength, so I think we will develop both strengths.
Oh, sorry.
For the weight loss and the diabetes.
Okay. I mean, there are 3 formulations for semaglutide: the Wegovy, the Ozempic, and the Rybelsus Novo, we'll be developing all 3.
Got it. Thank you so much.
Thank you, Ishita. The next question is again from Nitya, from Bernstein. A follow-up.
Thank you. This is again on semaglutide. semaglutide, the registered process is a recombinant process, but if you look at during discovery, it was actually done using a synthetic process. I can fully imagine players trying to figure out a synthetic process because your costs and operating efficiency is much better. Do you see that as a threat to your cost position? A broader related question, which is that if I look at tirzepatide, I think it's a synthetic process. I know there are a lot many more peptides in the pipeline, but do you eventually see synthetic routes of synthesis being figured out for most of these, and therefore your fermentation capacity is not really having long-term growth potential? How do you think about it?
Contrary to
Yeah, go ahead.
Contrary to your perception, actually, recombinant processes are more effective and cheaper to produce.
Yeah.
I think the big question there is the clinical trials that might be needed, to establish, you know, the immunogenic, you know, similarity. I think that's why people prefer to go down the synthetic route. We have capabilities in both, and we will basically, closer to the timeline, decide how do we approach this particular opportunity.
We will have both the products, synthetic as well as recombinant. I think that's what will be the differentiator compared to other competitors who mostly have only synthetic product. The regulatory part today, especially in the U.S., is more driving towards the synthetic than towards the recombinant. As Kiran mentioned, if it's a recombinant product, then you need extensive phase one, phase three kind of trials.
At least phase I.
Phase I. COGS, I think Kiran already mentioned that fermentation is lower than synthetic. When you look at the overall cost of the drug product, it's not a big differentiator in cost because majority of the cost comes from devices and drug product filling, then oils from the API load.
Thank you.
Thank you, Nitya. We'll take the next question from Sai Priyanka from Spheres. Please go ahead.
Hello. Hello, good morning, everyone. thank you for the opportunity. I would like to ask about Yesafili. What were the key points presented in the closing arguments of the BPCIA Patent Dance Case between Mylan and Regeneron? How might these arguments impact the approval and launch of the Yesafili? Thank you.
Okay. Let me, let me respond to that question. See, this is. There are things on the argument that I won't comment on, which is in the litigation. I will tell you that, that this has been a very different litigation in terms of an expedited request that was made, where we are litigating on a number of patents, which are limited, and we will look to see how the interim judgment comes through. As I've responded earlier, there is a guidance date, but we don't know exactly how that will play through. As regards to whether it has an implication on the approval, the answer to that is only for the final approval.
The approvability through a conditional approval, like we talked and Kiran referred to in our opening remarks, where Health Canada has already approved, conditional to the outcome of the litigation or the loss of exclusivity, basically. That is where, you know, it does not affect. You've also seen the European authorities, recommend the, the CHMP.
For approval.
-for approval, you know, we are looking forward to the FDA do the same. We look at, that conditional approval subject to LOE.
Okay. Thank you.
Thank you, Sai. ladies and gentlemen, that's the last question for today's call. I thank you for joining us today. If you have any further questions or need clarifications, please do, do get in touch with us. With this, we'll conclude, and have a wonderful rest of the day. Thank you.
Thank you.