Ladies and gentlemen, good day, and welcome to Zydus Lifesciences Limited Quarter Three FY 2026 earnings call. Please note, this call is being recorded. I now hand over the call to Mr. Ganesh Nayak for opening remarks. Thank you, and over to you, sir.
Good morning, ladies and gentlemen. It's my pleasure to welcome you all to our post-results study conference for the third quarter, ended December 31st, 2025. For today's call, we have with us Dr. Sharvil Patel, Managing Director, Mr. Tushar Shroff, Chief Financial Officer, Mr. Arvind Bothra, Head of Investor Relations, and Mr. Alok Garg from the Managing Director's Office. Let me talk about the key developments during the quarter. I'm happy to inform you that we ended the calendar year with a strong double-digit growth and operating profitability. All our key businesses contributed to the performance during the quarter. Let me take you through the financial performance for the quarter gone by. We registered consolidated revenues of INR 68.6 billion, up 30% on a year-on-year basis. Excluding acquisitions, too, the base sustained double-digit growth, with all key businesses delivering ahead of expectations.
EBITDA for the quarter stood at INR 18.2 billion, up 31% on a year-on-year basis. Our operating profitability continued to remain strong, with an EBITDA margin of 26.5% during the quarter, up 20 basis points on a year-on-year basis. EBITDA margin on for the first nine months of fiscal stood at 30.3%. Net profit for the quarter, adjusted for the exceptional expense on account of the new labor code impact and acquisition-related cost, was up INR 11.1 billion, up 9% year-on-year. Now, let me take you through the operating highlights for the third quarter of FY 2026 for our key business segments. In the pharmaceutical space, North America business, comprising of the United States and Canada, registered revenues of INR 28 billion during the quarter, up 16% year-on-year.
The base U.S. business continued to grow, driven by sustained volume expansion and new products launched over the last 12 months. On the U.S. generics front, we filed 18 ANDAs and received eight approvals and launched four new products during the quarter. On the U.S. specialty front, we launched Beizray, albumin solubilized docetaxel injection, our first oncology 505(b)(2) product, further strengthening our specialty portfolio. On the orphan and rare disease front, in January 2026, we received final approval from the U.S. FDA for ZYCUBO , copper histidinate, and with this approval, ZYCUBO has become the first and only therapy approved for the treatment of Menkes disease, which is an ultra-rare disease. We now have three rare disease products being marketed by Sentinel. In Canada, we filed five ANDAs, received four approvals, and launched one new product during the quarter.
In India, our branded formulation business sustained its growth trajectory with a robust 14% year-on-year growth, outperforming the market growth for yet another quarter. The growth was driven by persistent traction in innovation products and pillar brands. Chronic segment continued to grow at a faster pace, driving the overall growth of the business. In terms of therapy performance, the business grew faster than the market in key therapies of cardiology, respiratory, dermatology, pain management, and in the super specialty areas of oncology and nephrology. On the super specialty front, we continued to retain leadership position in the oncology therapy. Contribution of chronic portfolio has increased consistently over the last several years and stood at 45.3% as per IQVIA MAT December 2025, an improvement of 560 basis points over the last three years.
During the quarter, we expanded our presence in the diagnostics area through a strategic collaboration with Myriad Genetics of the U.S., introducing three advanced tests, namely MyChoice, MyRisk, and Prolaris, and thereby strengthening the country's precision oncology ecosystem. International markets formulation business further accelerated its growth trajectory and posted revenues of INR 7.9 billion with a strong year-on-year growth of 38%. The growth was strong, broad-based, with a demand-driven performance in both emerging markets and Europe, supported by focused execution. On a YTD basis as well, the business delivered 38% growth. On our consumer wellness business, we recorded revenues of INR 9.6 billion, up 113% year-on-year, with full quarter of consolidation of Comfort Click business in this quarter.
Excluding the impact of the recently acquired Comfort Click, the business delivered double-digit volume growth during the quarter, reflecting the underlying demand momentum. Comfort Click portfolio that was acquired this year, continued to perform in line with expectations. The Comfort Click business deepened its portfolio with the launch of four adult gummy variants, one probiotic gummy variant for the kids, one pure and Himalayan Shilajit resin, reinforcing its position in high-growth wellness categories. Additionally, the Weight World brand advanced its European expansion by entering Poland, Finland and Portugal, strengthening Comfort Click's regional footprint and unlocking access to fast-growing wellness markets. In the medical devices space, the business performed registered revenues of INR 3 billion. This was the first full quarter consolidation of our Amplitude Surgical business.
On the operations front, our injectable manufacturing facility located at Jarod received the EIR with voluntary action indicated status from the U.S. FDA post the inspection conducted in September 2025. Our oral solid dosage formulations facility located in Ahmedabad, SEZ-2, received EIR with no action indicated status, post the pre-approval inspection conducted in August 2025. This concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers across businesses as well as initiatives in our innovation program. Thank you.
Thank you, Mr. Nayak, and good morning, ladies and gentlemen. I'm pleased to report that our core strategic pillars are delivering as intended. Our focus on supply chain resilience and stringent execution has allowed us to navigate market complexities effectively. 2025 was a remarkable year for us, characterized by exceptional top-line growth and healthy profitability. Our disciplined M&A and business development strategy has complemented existing businesses well and activated new growth engines that are already delivering tangible impact. Building on the seamless integration of LiqMeds and NIPL, which is the Rightbite Max Protein, our recent acquisition of Amplitude, Comfort Click, licensing of biosimilars, and our strategic biologic facilities will serve as key enablers of sustained long-term business model to go beyond the pill, prioritizing patient-centric outcomes through sustained R&D investments.
This focus is not just about better healthcare, it's about creating superior value for everyone who has a stake in our success. In the U.S., our generic foundation is stronger than ever, anchored by a diverse portfolio of internal and partnered products. As we pivot to specialty, we are well-positioned to drive further growth. We have identified and engaged key levers to expand our footprint, ensuring we bring highly differentiated, high-impact therapies to the market. This includes the 552 pipeline of products developed in-house as well as through partnerships, leveraging LiqMeds' portfolio and broadening access to three pediatric disease products by Sentinel. In the U.S. biosimilar space, we have attained a critical milestone with the licensing of two large molecules, pembrolizumab and ranibizumab.
We shall leverage the recently acquired biologics manufacturing facility in the U.S. to escalate our proprietary pipeline, while maximizing capacity utilization through our continued supply of botensilimab to Agenus and the onboarding of new partners. Looking ahead, we are particularly optimistic about the upcoming NDA filing for our molecule saroglitazar in the U.S. market. This is a pivotal milestone that will not only catalyze addition as an innovation-driven leader in the specialty pharmaceutical space. Turning to our India formulations business, our branded portfolio has consistently outperformed the market for now several quarters. We are accelerating this momentum by sharpening our focus on our core therapeutic areas. Our commitment to patient-centric innovation has yielded a robust pipeline of novel, differentiated products that not only address significant unmet needs, but also serve as a foundation for sustained long-term value creation.
On international markets formulations business, spanning both emerging markets and Europe, it has delivered strong double-digit growth over the past several quarters. In emerging markets, we are driving growth through a therapy-led approach, tailoring offerings to local needs and building a more agile market-responsive portfolio. Whereas in Europe, our priority is to broaden our portfolio offerings and strengthen our market coverage. Our strategy for consumer wellness is centered on making wellness a natural extension of the consumer's journey. The acquisition of Comfort Click has uniquely positioned us with strong presence in both India and Europe's developed market, enhancing diversification and growth potential. With the addition of Comfort Click, we have reached a critical inflection point. This move not only expands our global footprint, but also secures a leadership position in the rapidly evolving digital field.
We are building a sustainable, scalable wellness platform framework designed to deliver superior long-term returns. On the MedTech front, we received an important milestone with the CE mark approval for our proprietary HandX robotic surgical system. This confirms its compliance with the European standards for safety, performance and quality. With this, let me share some material developments on our innovation efforts during the quarter. On the NCE front, as I mentioned, we plan to file saroglitazar magnesium with the U.S. FDA for PBC indication. In the biotech R&D space, we received regulatory approval in India to initiate phase three clinical trials of our second biosimilar ADC. On the vaccines front, we initiated a phase two trial for bivalent typhoid conjugate vaccine in India.
On our global vaccine strategy is now playing out, as recently we have been awarded the tender to supply rabies vaccine to PAHO for Latin American countries and the typhoid conjugate vaccine to UNICEF for low and middle-income countries. On the 505(b)(2) front, we have entered into an exclusive licensing and commercialization agreement for a novel sterile 505(b)(2) product in the area of supportive oncology care. The NDA for the product is expected to be filed with the U.S. FDA in 2026. This will allow us to have a second launch in queue. Now we can start with the Q&A session. Over to the coordinator for the Q&A.
Thank you, sir. We will now open the call for Q&A session. We will wait for a few minutes until the queue assembles. We request participants to restrict to two questions and then return to the queue for more questions. Please raise your hand from the participant tab on the screen for asking the question. The first question is from Neha Manpuria.
Yeah, thanks for taking my question. My first question is on the Agenus deal. Now that we've completed the acquisition of the asset, as I said, you mentioned in your opening remarks that the, you know, initially there'll be supplier botensilimab, you know, before we start onboarding customers. In true sense, when should we start assuming revenue from, you know, the CDMO business? You know, would it be, you know, FY 2027, the latter half, FY 2028, or could it take some more time? And, you know, let's say over a 3-4-year period, you know, how big can, you know, the CDMO business, be for us under Agenus?
Yeah, thank you, Neha. So I think we'll see the commercialization start from the second half of FY 2027 when we start supplying Bot/Bal. In the meantime, we are obviously getting the facilities qualified. And we are growing the portfolio. So, but I would say the commercialization will be second half of FY 2027. In terms of scaling up of the CDMO business, it will take at least two to three years. Obviously, one milestone will be the how Bot/Bal moves forward in its clinical and regulatory journey, and we are quite optimistic with the traction it is seeing in Europe and also the trial, how they're moving. And then obviously further addition of new CDMO business.
So in the next two to three years, we would say we would have a meaningful bio CDMO business.
Are we quantifying, sir, what this meaningful would be? I mean, would it be, let's say, INR 50 million or INR 70 million, INR 100 million? I mean, what can be the number that we could look at from this facility?
No, it will be a little higher than that.
All right. Okay. My second question is on the cost. Now, obviously, we saw the full consolidation of Comfort Click and Amplitude in this quarter. We'll probably have, you know, the CDMO costs coming through, and then we have Saro next year. So if I were to look at FY 2027, you know, what should be a good cost estimate that we should look at? I mean, from the current, if I were to strip out the R&D number, I think we are close to about, you know, INR 1,600-1,650 crores. So roughly what would be this number on a run rate basis in 2027? And when should we start seeing the Saro commercialization cost, you know, the MR, et cetera, that cost?
Oh, hi, Neha, this is Tushar. Our current run rate, you know, in terms of other expenses, excluding R&D expenditure for this particular quarter, and what we expect is about INR 1,750 crore-INR 1,800 crore, excluding R&D spend. But, you know, the Agenus expenses will be, you know, we are expecting that to be about, you know, around $20 million on other expenses. So we'll have to see that, you know, in terms of, on an annualized basis, if it is about $20 million, how the phasing is going to happen. But our current run rate is expected to be about INR 1,750 crore-INR 1,800 crore, excluding R&D OpEx.
This includes the $20 million from Agenus and the Saro costs that we will incur, right?
No, this does not include that.
Oh, the INR 750- INR 1800 is excluding the Agenus and Saro costs?
Yeah. The Saro, any kind of a launch-specific expenses is not included in this.
When would we start seeing that, given that we will file the product now, you know, probably if I earliest I can, you know, if we expect launch in end FY 2027, should we... Fiscal 2027, should we start assuming some cost coming through in 2027, or it will largely be a 2025, a 2028 sort of, you know, cost where we see for Saro?
No, 2027 we'll see a meaningful cost from Saro.
Okay, we are not quantifying that at the moment?
FY 2027. No, I think it's, as I said, it'll slowly ramp up because we have... It depends once on filing and how we are going ahead with the hiring and other strategic initiatives. So it's too early to give a guidance, but, it will be meaningful, but it will be building up, as we move through the year.
All right. Thank you so much.
I think, Neha?... the idea is that, you know, once we are able to close on the budget and other things, probably Q4 will be the better time for us to give you the better guidance.
Okay, that's helpful, Sharvil. Thank you so much.
T hank you. The next question is from Saion Mukherjee.
Yeah, hi. Thanks for taking my question. So the R&D cost has gone up significantly this quarter. Can you just explain, and, you know, your comment mentions around maybe INR 100 crore plus increase in other expense in the quarters ahead. What is going to drive this further increase? Is it R&D or something else which will drive that number?
So R&D, thanks, Saion. So R&D, we are, as I said, we expect a 7.5%-8% of our revenue for FY 2026. That's what we guided for. There is always lumpiness to R&D in the third quarter, which is October, December happen, actually a significant amount of them. And also then, the different clinical trials that are going on for our biologics and others. So it's, generally that lumpy, but, and we've seen that in the last year, same quarter as well. But yeah, we are guiding towards the 7.5%-8% for this financial year.
Okay. Okay. My second question, you know, is regarding, you know, international market, where we have seen significant growth in the recent past. If you can give some color, what happened over the last four- five years, you know, the business has almost tripled. And how should we think about it going forward?
So, I would say, as I said, there are two, three things that is one is the key focus on the markets, and doubling down on the branded space in the EM space with CVS. I mean, CNS being the most important part, and then we are also expanded to some other metabolic disorders, including pain. So that's helping us. And so while there have been up and downs that have happened in different markets, but overall, I think markets have done very well in terms of growth. The second is expanding our access to more markets, with the quality of filings that we have and the products that we have, where we are many times semi-exclusive or exclusive because of the technology. We are seeing good, good traction to execute new markets, in terms of launch.
Europe, which was going through a challenge for us in the last three years, in the last year and this year, have done meaningfully better, and they're significantly scaling up their business with both reach as well as the product portfolio growing. And that's also helped the overall business in terms of growth. And I would say also, all the new markets that we entered, like U.K. and some of the markets in EM, all of them have significantly tracked better than expectations, both on revenue and margins. So that has led to the overall growth. So I would say a lot of it led by good portfolio, which is there, which we are accessing for these markets, and then very strong execution in the market.
And so you see this as sustainable, like at least double-digit growth to continue in the coming two, three years?
Yeah, we see meaningfully 20%+ growth continuing for the near future.
Okay. And so just one last question on the U.S.. If you can comment on Revlimid, whether it was largely slow this quarter, and also on Mirabegron, there are some news of settlement by Lupin. So how should we think about the landscape on Mirabegron, which is a big contributor for you currently in the U.S.?
So yeah, on Revlimid, as I said, every quarter, the trajectory is on a downward trend, and even in this quarter gone by, it's a very small part of the overall business now, and we won't see anything in the next quarter. So we have sort of completed our business sort of, so to say, by 5/26 on lenalidomide. And so by and large, this quarter is gone, and next quarter we will not see anything. With regard to mirabegron, the trial started as of Monday, on 9th February , with jury selection. The parties will start presenting the case on Tuesday, which is February 10th, and the court has directed the parties for mediation while the trial is proceeding. So that's where we are today.
Any comments on possible competitive landscape there over the next year or so?
No, I mean, it's difficult to say. Obviously, Lupin has settled from what we hear today morning. So there is some write-up there. But, I would say, I would still refrain from saying anything till after the trial or after the mediation.
Okay, thank you.
Thank you. The next question is from Bino.
Hi. Good morning. Sharvil, just to follow up on the previous question, what is the outcome of the trial? Or, let me put it this way: Is there any sort of outcome of the trial by which this opportunity of mirabegron can stay exclusive to current players in the market for next three to four years?
As I said, it will be better... the trial is just about to start. It will be better to not comment on that outcome right now.
... Got it. On this Keytruda partnership that you have got into, are you expecting this to be the first biosimilar to market to Keytruda?
So in terms of the product that we have licensed, you would, I think from public domain, it is also known that the, this company is the furthest ahead in terms of both the clinical trial and the revised clinical trial guidelines. Actually, they shaped that guide, almost, you know, way of in terms of how this will move forward. So they are furthest ahead in terms of the clinical development and FDA guidance that the firm has received. So there is. We are also hoping that we do get to file as the first biosimilar and potentially also find a meaningful opportunity for launch, being the first filer.
Understood. Again, from public sources, it seems that Keytruda key patents are expiring 2028, 2029. You know, without any explicit guidance, is that roughly the timeline around which we could target the launch?
Yeah, we would be prepared with the kind of timelines that IPD and others are saying, even the commentary that we have heard from various sources. So we would want to be prepared for that timeline.
Understood. One last question on Jardiance empagliflozin. I believe we are one of the first to file. Do we have any chance of... Is it going to be any materially meaningful product for us, even if it is a couple of years out?
So I would say overall, we do have been had a good success in terms of first to file and also settlement. So we are quite, we do see a lot of good pipeline of products coming through, including Empa. But also importantly, even in the year gone by, we had, we have filed almost four to five against sole exclusive first to file. So it's probably been one of the best years for Zydus in terms of sole first to file opportunities that we have seen. So we are quite excited with the prospect of future pipeline that we'll get to launch.
Got it. Sorry, I didn't understand. Is Empa going to be a sole opportunity for you, or will it be shared?
No, no, Empa is not a sole, but as I said, beyond that also, we have filed at least four four sole first-to-files this year.
Understood. Okay, thanks. I'll join back.
Thank you. The next question is from Nitin Agarwal. Hi, Nitin, can you hear us?
Hello?
Okay, we move on. Yeah, Nitin, can you hear us?
Yeah, I can hear you. So I was saying that, you know, with the, you know, in the U.S., with Revlimid not being there from the next quarter onwards, as you guided, and some of our major first to files also kicking in the second half of the year, how should we think about the U.S. business growth for the interim next, three to four quarters?
So we have guided that we will still see growth in the U.S. in the coming year. In fact, even in FY 2026 in the calendar year, we have seen 11% volume growth for our U.S. business. While the market has grown at 1%, we have grown at 11%+ on the volumes, so which is also helping. So both the base business is robust really growing. We still continue to launch meaningfully a lot of products in the U.S., and we'll continue in this year also. And then, as I said, as the year comes nearer to the end, we'll have some exclusive launch also. So we will see a good growth continue in the U.S. generics business.
Okay, sir. Thank you so much.
Thank you. The next question is from Surya Patra.
Yeah, thank you for this opportunity, sir. I will just extend my question on the U.S. growth side. sir, what are the key triggers that you are witnessing as the growth driver for the, let's say, next one or two year? And, when we talk about the specialty opportunities, we have already seen this rare disease product also that is there in the U.S. market already. So considering all that, how big the specialty contribution would be to the U.S., and, how significantly it can ramp it up, what do you think? And, what other triggers that you find for the U.S. growth for the next two year?
So in the next, you know, medium term, in the next two years, obviously, we have very important launches, four to five sizable launches that we will get to see, and some where we are sole exclusive, in the market. Beyond that, obviously, we have plans to launch, 40-45+ products, in FY 2027, and we continue to have a large, growth trajectory going forward as well. And then the whole 5x2 franchise of liquids, as well as, the supportive onco product like Beizray. As I said, we file one. We hope to file one more soon with a partner and also potentially launch it in a year's time. So all of that will lead to adding, further value on, that.
We just licensed Ranibizumab, also biosimilar, so we also see that in the second half of the year, a launch of that. So overall, I would say the specialty / 505(b)(2) pipeline will grow very well with biosimilars entering also. Beyond that, obviously, Sentinel has three just launched ZYCUBO, and we'll see a good year for Sentinel in the coming years. So that part of the specialty business will also meaningfully track. And as I said, our generics business continues to do well. We had 11% volume growth in spite of what the market is, and that likely will continue.
Okay. So here price erosion is single digit. That is how one should consider when you say 11% volume growth?
Yeah, I mean, other than lenalidomide and others, we single digit.
Okay.
Sorry, can you repeat that?
So, when you say 11% kind of volume growth, price erosion should be single digit. That is what one should believe?
Yeah.
Okay. My second question is on the margin scenario going ahead. The couple of factors that is likely to play out, the obviously the lenalidomide factor. Secondly, the R&D, higher R&D spend that we are likely to see and the blended margin implication of the two larger acquisition, what we have recently seen, the Amplitude as well as the Comfort Click. I think that is, on a blended basis, margin is lower than the current margin scenario or our reported margin, our base business margin, excluding Revlimid. That is the kind of margin what the acquisitions should be having. So given that, there is a kind of a visible pressure on the margin on the subsequent quarters, that is, it looks like. Any sense or any commentary on that?
So I think for obviously, the, we have had exceptionally high margin, much significantly higher than even any industry margin that has existed in FY 2026. If you look at... Going forward, lenalidomide, that we will see in quarter four, which we would probably see very little growth or very little or no sale also on lenalidomide, we would still ex- we still expect a 23%+ margin. And so I think, while we-- Yes, you are right, CCL will have lower margins. Overall, consumer business next quarter, which is a bigger quarter, will have lower margins, and Amplitude has a little, I mean, it's near to it, but similar margin. We will still track at 23%+ margin in the quarter four.
Okay. So just one clarification, sir. This Amplitude, what is the like-for-like growth that we would have seen in this quarter? Whether the metric revenue, what we have reported, it is purely Amplitude or something else also that is included there?
Is that plus some cardiovascular sales as well?
Okay. What was the like-for-like growth in the Amplitude, sir?
It's high single digit growth for the like-to-like business.
Sure, sir. Yeah. Thank you. Wish you all the best.
Thank you. The next follow-up question is from Bino.
Hi. Thanks again. Just following up on the product, Palbociclib, which we have in-licensed, is it as of today a FY 2027 opportunity or an FY 2028 opportunity?
I missed the first part, when you said licensed.
Yeah. Palbociclib, which we have in-licensed. I believe there was some patent, pediatric extension which was awaited. So as of now, would it be a FY 2027 opportunity or a FY 2028 opportunity?
So that we can't answer because if the pediatric exclusion is granted, then it will be FY 2028, otherwise it could be FY 2027.
Okay. And, risdiplam continues to be a FY 2027 opportunity, right?
Yes.
Got it. One last question on this product, enzalutamide, Xtandi. Is that a material product for us whenever it comes?
I'll ask Arvind to come back to you on that specific product. Off the top of my head, directly, I can't answer that.
Okay.
Because I do not have it yet. Yeah.
Thank you.
Thank you.
Thank you. The next follow-up question is from Saion Mukherjee.
Yeah, thanks for the follow-up. Just a couple of questions on India. I think the growth that you are reporting, would it be fair to assume or assess that, a fair bit of it is being contributed by bortezomib, desidustat, and your biosimilar portfolio? And in that context, like, how should we think about these products growing? Because I think this year has been a good step up, particularly for desidustat. Where do you see these brands, you know, the peak sales potential, particularly for Saro and desidustat? And are there any patent risks that we need to be worried about on these products over the next three-four years?
On the patent risk, no, we have a longer patent life. In terms of traction, yes, our innovative portfolio is growing much faster. It's growing at 23%+. Or but also our growth booster brands, which are those 30-odd brands that we focus on, are also growing at greater than 13%. So I would say overall, the portfolio is tracking very well. And as this product scale up, like Saro, Desi, also our biologics portfolio business also, we'll see a better trajectory on that. You know, we are, Saro is already overall a 450+ growth franchise as a molecule. And we see the very strong, very significant strong growth continuing for the franchise, so we're quite bullish on Saro.
Also, Desi similarly, we only see stronger traction going forward. And so I think from that point of view, yeah, the patented molecules are doing very well. The biologics are also doing extremely well. And as I said, even beyond that, our growth booster brands, which are beyond these, are also tracking significantly better than market. And-
Okay.
On vaccines and other business also, which is separate. Yeah.
Okay. Okay. So just on, you know, mentioned about some tender wins on vaccines. So how large are these potential, and when should we consider in these revenues in our models?
So this year, we have definitely grown very well, and next year we also have a very significant growth expectation on vaccine. In the India public tender market, we had won last year, FY 2026, the MR tender, which is INR 100+ crore already opportunity that we have realized on a single product. Our very strong traction on our flu vaccine, which is also gaining meaningfully, and we hope to become the largest flu player in India very soon. And the rabies vaccines have done extremely well in the Indian market, as also with pre-qualification. I think as we get to the global tenders, you know, obviously there are... We're starting off on some of them, so the initial starts are small, but as we get into the second year, third year, the supplies go up.
As I said, I have very strong value out of vaccines. In the next three to four years, we want to have INR 1,000 crore+ business on vaccines for sure, and that's what we are tentatively in.
Okay. Okay, thanks.
Thank you. The next question is from Bansi Desai .
Yeah, hi. Thanks for the opportunity. Sharvil brother, my question to you is on our M&A strategy. So you had earlier outlined, you know, that your you would want to scale up U.S. specialty through inorganic opportunities. And therefore, you know, if you could provide an update on the progress of this strategy and the nature of assets that you are prioritizing, you know, in terms of therapy areas or commercial stage of these assets.
So in the U.S., as I said, yes, we are looking to how do we diversify and have a more specialty-driven business. So it's a meaningful... I mean, I think the couple of meaningful things that have happened for us is obviously the launch of ZYCUBO, which is our third specialty drug or a rare disease drug that has happened. And we do see traction to being able to find more of these opportunities in the next, you know, year or two. We hope to at least get one or two deals almost every year. So that's one BD&L opportunity and licensing scale up, and we've done well so far, and we continue to track well in terms of getting more leads.
Beyond that, obviously, we are building the 505(b)(2) specialty space, with supportive onco as the key area that we're focusing on. And we want to push for that further. I think the biosimilar launches will also aid to that. Ranibizumab will also be a type of specialty launch in the U.S. market. So we are excited with that opportunity also as we move forward. So overall, yes, the specialty business will continue to grow. And then finally, for our saroglitazar part of the portfolio, once we come near to launch, we are hoping to find more assets to add to Saro, both mostly commercial assets.
We continue to track and see what we can look for and, but it will be in the liver, hepato-gastro space adjacency, or at least any niche, adjacencies in major diseases. So it will be mostly, specialty-driven portfolio acquisition, if we are able to do.
And any plans to augment this, you know, you know, via assets which have, you know, commercial infrastructure, you know, or capabilities around that?
Yes. That is also a way we are looking at it.
All right. And, my second question is on India. You know, given our innovative brands are doing well, our chronic mix is going up, we will also see potentially GLP-1 launches. So fair to assume that, you know, our India business should, you know, track that, you know, double-digit growth, you know, for the next two, three years, you know, based on the portfolio that we have today?
Yes, we have, I think we have a strong momentum for our innovative brands. Also, we will have semi-launch, as well as many other interesting first day one launches in the market. Also future more proprietary new drugs to come. So we are quite bullish on double-digit growth for India.
All right. Thank you.
Thank you. The next question from Devang Sarawgi.
Good morning, sir.
Good morning.
We secured shareholder approval for INR 5,000 crore QIP back in December. Given that two months have already passed, could you clarify if the fundraising is strictly contingent on any acquisition, or we are waiting for better market conditions to minimize dilution?
... It is, it is mostly contingent on if we get to see any major opportunity. As I said, our internal accruals are, I mean, and cash flows are sufficient for us to, you know, continue to do what we need to do without fundraise. Fundraise is an enabling provision for us to use if we feel that we need to, provided we can see any meaningful acquisition.
And secondly, if you can provide any clarity for mirabegron litigation, what should we assess the maximum risk limit for the product?
As we speak, we are in litigation, so I don't think we'll be able to make any comments for now.
Okay, thank you.
Thank you.
Thank you.
The next question is a follow-up from Surya Patra. Hi, Surya, requesting you to unmute and ask your question.
Yeah. Thank you, sir. Just wanted to understand how important this Myriad genetic collaboration will be for us, and what is the opportunity that we are trying to target here?
So, you know, we had earlier already licensed one opportunity in the liquid biopsy space with Guardant, and that's tracking extremely well in India. And the liquid biopsy business for Guardant, which Zydus is exclusively managing, is doing extremely well. This will significantly add to that capability on creating more opportunity and access for patients to test for genetic disorders as well as not genetic, for genetic conditions related to cancer and others. So this, I think, our view is in the next two to three years, this would be a very meaningful business, sticky business for the company. It's already tracking very well with just cancer diagnostics and the liquid biopsy business, and this will significantly add further opportunity for the company.
Beyond that, obviously, we create a very strong, patient angle to how we manage the whole ecosystem or for cancer, for both the oncologist as well as the cancer patient, in terms of, you know, giving them additional opportunities for them to test and, early diagnose. So I think all of that will lead to us continuing to be the largest Indian oncology player, as we intend to be. But also not only be the largest, but also create more value for the patient.
Okay. Second one, just a clarification further, again, on the GLP-1. I believe we had mentioned earlier that we may not be there in the first wave of the commercialization in India or emerging market, because our product would be slightly differentiated product than the pure plain vanilla generic of semaglutide. So, if you can clarify, sir, because you have got the approval from the CDMO about your generic version. So what strategy that you are likely to play here, and what is your manufacturing arrangements or partnership arrangement for GLP-1?
So I think, Surya, there may have been some misunderstanding. We will be in the first wave of launches when it comes to India launch. We will also be partnering with at least two or three companies who will use Zydus' sema to launch. So we are definitely in the first wave. We already have marketing authorizations and all of that. So that is happening. In terms of... And that will be with our novel formulation. In terms of other markets, we, as I said, we are saying we are not in the first wave when it comes to other markets, but in probably in the next 12 months, we will enter those markets also. But in India, definitely, we will be on day one, post-IP.
What is the novelty that we are talking about here?
So we have a new formulation where we, it's a very significant ease to the patient in terms of use. Also, there is a very meaningful benefit in terms of cost, because today, typically you, for weight loss, you have to shift from the first four weeks to the next four weeks with a different dose, and that means a different pen device. For us, we have a time, and we don't need to make any changes from the initial dosing to the higher dosing. With the same device, it continues. So it'll definitely add significant ease of use for the patient, and much less complexity for patients to learn two devices.
Also, the supply chain-wise, it becomes much easier because you're not carrying two different devices for only first four weeks and then the future. So all of that is going to lead to very meaningful, I would say, patient burden being lower in terms of understanding and use, and carrying, and also in terms of supply chain, also convenience of dosing.
Okay. Okay. Just last one point, sir. On the finance cost side, we are having the cash balance as well as the debt, so that's why the interest cost is seeing a kind of sequential rise. So generally, what is the kind of a thought process here going with when we think about FY 2027 and beyond?
So on net debt basis, we have INR 3,000 crore of debt as of now, and I would say that's because of, obviously, the large acquisition that we have done, recently, but I think we are more than comfortable in terms of our net debt position.
Okay. Okay. Yeah, thank you, sir. Wish you all the best.
Thank you.
Thank you. The next question is from Gaurav Tinani.
Yeah, hi, good morning. So the first questions on the biosimilar strategy. So firstly, on ranibizumab, just want to understand the landscape right now. I believe, you know, Sandoz was also selling or was in a partnership with Formycon for ranibizumab, but then they kind of withdrew from the market. Now, we've also got into an alliance with Formycon. So, do we see the commercial landscape still attractive? And do we see this as, you know, Sandoz, when can they reenter the market, and when can Zydus enter the market here, please?
So like I said, we hope to enter in the second half of the year. That's where we are planning for launch. There is definitely an opportunity where there is not enough biosimilars available on ranibizumab in the market, and we see that as an opportunity.
So Sandoz had, you know, almost a 48% share, and they still withdrew from the market. Now, you know, any read-through from there, why did they withdraw from the market? And now we've also taken Formycon's product. So, you know, why did Sandoz withdraw the market?
No, I don't have... I mean, regulatory reason, maybe a commercial reason. I don't know.
Got it. Got it. Okay. Secondly, for biosimilar Keytruda, which, you know, the next clinical milestone in terms of the phase I study completing, when can we expect the readout for that? Or do you see that in H1 of this calendar year, H1 of, say, 2026?
Yeah, we will see it in this year, I mean, this calendar year.
This calendar year. Okay, got it. If, if the study is successful, in the press release we've also mentioned that, you know, we can use a Agenus's facility for manufacturing in the future. Now, the initial filing on successful study, will that include Agenus site, or that will include an alternate site initially for Formycon, and then Agenus site will be included subsequently? Any readout on that, please?
So currently, we, Formycon manufactures it in a European facility, and we are going to file as a primary filing through that. Subsequently, we will evaluate as a second source filing, whether we need to, we will use our U.S. facility. But currently the BLA application will be submitted through the Europeans. Right.
Got it. Sir, last question. I think we've guided for, you know, 23% plus margins in Q4 of this year. With next year, the US growing, emerging markets growing 20% plus, India also growing in double digits, any guidance for EBITDA margins for next year?
I think, as I said, the best is to for us to give you the next quarter guidance. And I think as we start the next financial year, we'll probably come out with better more near-term guidance. But right now, I would say the nearest guidance is we'll try be in the fourth quarter, despite no revenue on lenalidomide, we'll see a 23% plus margin.
Okay, sir. Thank you. All the best.
Thank you. We wait for few minutes until the queue assembles. Requesting participants to please raise their hand from participant tab on the screen to ask question. If there are no further questions, we'll take a follow-up question from Gaurav Tinani.
Yeah. Sorry, one last question. So, as we are building in, you know, slight ramp-up in other expenses ex R&D, which we guided earlier in this call, what would be the key levers for, you know, this, higher OpEx, spend? Would there be a, you know, a field force dedicated for GLP? Would there be a field force for biosimilars driving this, or would there be, you know, marketing spend in Comfort Click or, you know, additional field force and Amplitude driving this? Any read-through for that, please?
No, none of those. The, it's the acquisitions that have led to obviously some of the higher base being created. But there is no addition of force, the field forces in the current acquisition or the current businesses. Future, Saro will have a commercial team, which is not baked in yet.
So the biosimilars field force for ranibizumab would be the same, which we use for the 505(b)(2)?
Yeah.
Products?
It is largely in the same number of people we have. We'll reorganize a little bit.
Okay, sir. Got it. Thank you.
Thank you. I think
You. Yes, sir. We can, we can have a closing remarks and then close the call.
Yeah, thank you. I think as, as I think, the organizer said, there are no further questions. Thank you, everyone, and we look forward to seeing you in the next quarter.
Ladies and gentlemen, that concludes today's conference. Thank you for joining us, and you may now disconnect your lines and exit the webinar. Thank you.
Thank you.