Zydus Lifesciences Limited

Zydus Lifesciences Limited

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Q3 FY2026 · Earnings Call TranscriptFebruary 10, 2026

Operator

Ladies and gentlemen, good day, and welcome to Zydus Lifesciences Limited Q3 FY26 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.

Ganesh Nayak

Good morning, ladies and gentlemen. It's my pleasure to welcome you all to our post-results teleconference 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 the 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 68.6 billion rupees, 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 18.2 billion rupees, 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 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 11.1 billion rupees, up 9% year-on-year. Now, let me take you through the operating highlights for the third quarter of FY26 for our key business segments.

In the pharmaceutical space, North America business, comprising of the United States and Canada, registered revenues of 28 billion rupees during the quarter, up 16% year-on-year. The base US business continued to grow, driven by sustained volume expansion and new products launched over the last 12 months.

On the US generics front, we filed 18 ANDAs and received eight approvals and launched four new products during the quarter. On the US specialty front, we launched Bizre, 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 US 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 Sentynl.

In Canada, we filed five ANDSs, received four approvals, and launched one new product during the quarter. In India, our branded formulations 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 US, introducing three advanced tests, namely MyChoice, MyRisk, and Prolaris, and thereby strengthening the country's precision oncology ecosystem.

International markets formulations business further accelerated its growth trajectory and posted revenues of 7.9 billion rupees 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 9.6 billion rupees, 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 WeightWorld 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 registered revenues of 3 billion rupees. 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 US FDA post the inspection conducted in September 2025. Our oral solid dosage formulations facility located in Ahmedabad SEZ II 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.

Sharvil Patel

Thank you, Mr. Nayak, and good morning, ladies and gentlemen.

I am 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 RiteBite Max Protein, our recent acquisition of Amplitude, Comfort Click, licensing of biosimilars, and our strategic biologics facilities will serve as key enablers of sustained long-term growth. We continue to build our business model to go beyond the pill, prioritizing patient-centric outcomes through sustained R&D investments.

This focus is not just about better health care, it's about creating superior value for everyone who has a stake in our success. In the US, 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 505(b)(2) pipeline of products developed in-house as well as through partnerships, leveraging LiqMeds portfolio, and broadening access to three pediatric disease products by Sentynl. In the bios- US 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 US to accelerate our proprietary pipeline while maximizing capacity utilization through our continued supply of botpal to Agenous and the onboarding of new partners. Looking ahead, we are particularly optimistic about the upcoming NDA filing for our molecule, saroglitazar, in the US market.

This is a pivotal milestone that will not only catalyze our transition 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 com- consumer's journey. The acquisition of Comfort Click has uniquely positioned us with strong presence in both India and Europe's developed markets, 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 health and wellness commerce space.

In essence, we are building a sustainable, scalable wellness platform framework designed to deli- deliver superior long-term returns. On the MedTech front, we received an important milestone with the CE Mark approval for our proprietary Andis robotic surgical system.

This confirms its compliance with 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 US FDA for PBC indication. In the biotech R&D space, we received regulatory approval in India to initiate Phase 3 clinical trials of our second biosimilar ADC.

On the vaccines front, we initiated a Phase 2 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 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 US FDA in 2026.

This will allow us to have a second launch in Thank you, and now we can start with the Q&A session. Over to the coordinator for the Q&A.

Operator

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.

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 sir, you mentioned in your opening remarks that initially there'll be supply of botpal before we start onboarding customers.

In true sense, when should we start assuming revenue from the CDMO business? Would it be FY27, the latter half, FY28, or could it take some more time?

Let's say over a three-, four-year period, how big can the CDMO business be for us under Agenus?

Sharvil Patel

Thank you, Neha. We'll see the commercialization start from the second half of FY27 when we start supplying botpal.

In the meantime, we are obviously getting the facilities qualified, and we'll go in the portfolio of both the front. I would say the commercialization will be second half of FY27.

In terms of scaling up of the CDMO business, it'll take at least two to three years. Obviously, one milestone will be how botpal 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.

Then, obviously, further addition of new CDMO business. In the next two to three years, we would say we would have a meaningful bio-CDMO business.

Neha Manpuria

Are we quantifying, sir, what this meaningful would be? Would it be, let's say, $50, $70, $100 million?

What can be the number that we could look at from this facility?

Sharvil Patel

No, it'll be a little higher than that.

Neha Manpuria

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 the CDMO cost coming through. Then we have Saro next year.

If I were to look at FY27, what should be a good cost estimate that we should look at? From the current, if I were to strip out the R&D number, I think we're close to about 1,600, 1,650 crores.

Roughly what would be this number on a run rate basis in '27? When should we start seeing the Saro commercialization cost, the MR, etc., that cost?

Tushar Shroff

Hello, Neha. This is Tushar.

Yeah. Our current run rate in terms of other expenses, excluding R&D expenditure for this particular quarter, and what we expect is about 1,750 to 1,800 crores, excluding R&D spend.

The Agenus expenses, we are expecting that to be about around 20 million on other expenses. We'll have to see that in terms of on annualized basis if it is about 20 million, how the phasing is going to happen.

Our current run rate is expected to be about 1,750 to 1,800 crores, excluding R&D opex.

Neha Manpuria

This includes the 20 million from Agenus and the Saro costs that we will incur, right?

Sharvil Patel

No, this does not include that.

Neha Manpuria

Oh, the 1,750 to 1,800 is excluding the Agenus and Saro costs?

Sharvil Patel

Any kind of a launch-specific expenses is not included in this.

Neha Manpuria

When could we start seeing that given that we will file the product now, probably if we expect launch in end FY27, fiscal '27, should we start assuming some costs coming through in '27, or it will largely be a '25, a '28 sort of cost where we see for Saro?

Sharvil Patel

No, '27 will see a meaningful cost on Saro.

Neha Manpuria

We are not quantifying that at the moment?

Sharvil Patel

No, as I said, it will slowly ramp up because it depends once on filing and how we're going ahead with the hiring and other strategic initiatives. It's too early to give a guidance, but it'll be meaningful, but it'll be building up as we move through the year.

Neha Manpuria

All right. Thank you so much, sir.

Sharvil Patel

I think, Neha, the idea is that 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.

Neha Manpuria

That's helpful, Tushar. Thank you so much.

Operator

Thank you. The next question is from Saion Mukherjee.

Saion Mukherjee

Hi. Thanks for taking my question.

Sir, the R&D costs have gone up significantly this quarter. Can you just explain?

Your comment mentions around maybe 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?

Sharvil Patel

Thanks, Saion. R&D, as I said, we expect a 7.5% to 8% of our revenue for FY26.

That's what we guided for. There is always lumpiness to R&D.

In the third quarter, which is October, December, happened actually a significant amount of them, and also then the different clinical trials that are going on for our biologics and others. It's generally that lumpy.

You've seen that in the last year same quarter as well. We are guiding towards the 7.5% to 8% for this financial year.

Saion Mukherjee

Okay. Okay.

My second question is regarding 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, the business has almost tripled.

How should we think about it going forward?

Sharvil Patel

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 CNS being the most important part, and then we are also expanded to some other metabolic disorders, including pain. That's helping us.

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 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.

That's also helped the overall business in terms of growth. I would say also all the new markets that we entered like UK and some of the markets in EM, all of them have significantly tracked better than expectations, both on revenue and margins.

That has led to the overall growth. I would say a lot of it led by good portfolio, which we are accessing for this market, and then a very strong execution in the market.

Saion Mukherjee

You see this as sustainable, at least double-digit growth to continue in the coming two, three years?

Sharvil Patel

We see meaningfully 20%-plus percent growth continuing for the near future.

Saion Mukherjee

Okay. Sir, just one last question on the US, if you can comment on Revlimid, whether it was low this quarter, and also on mirabegron.

There are some news of settlement by Lupin. How should we think about the landscape on mirabegron, which is a big contributor for you currently in the US?

Sharvil Patel

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. We won't see anything in the next quarter.

We have sort of completed our business sort of so to say for FY26 on lenalidomide. 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 Feb with jury selection. The parties will start presenting their case on Tuesday, which is Feb 10th.

The court has directed the parties for mediation while the trial is proceeding. That's where we are today.

Saion Mukherjee

Any comment on possible competitive landscape here over the next year or so?

Sharvil Patel

No. It's difficult to say.

Obviously, Lupin has settled from what we heard today morning. There is some write-up there.

I would still refrain from saying anything after the trial or after the mediation.

Saion Mukherjee

Sir. Thank you.

Arvind Bothra

Thank you. The next question is from Bino.

Bino Pathiparampil

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 kind 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?

Sharvil Patel

As I said, the trial is just about to start. It will be better to not comment on that outcome right now.

Bino Pathiparampil

Got it. On this Keytruda partnership that you have got into, are you expecting this to be the first biosimilar to market to Keytruda?

Sharvil Patel

In terms of the product that we have licensed, I think from public domain it is also known that this company is the furthest ahead in terms of both the clinical trial and the revised clinical trial guidelines. Actually, they shaped that in terms of how this will move forward.

They are furthest ahead in terms of the clinical development and FDA guidance that the firm has received. 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.

Bino Pathiparampil

Understood. Again, from public sources, it seems the Keytruda key patents are expiring 2028, 2029.

Without any explicit guidance, is that roughly the timeline around which we could target the launch?

Sharvil Patel

We would be prepared with the kind of timeline that IPD and others are saying and even the commentary that we have heard from various sources. We would want to be prepared for that timeline.

Bino Pathiparampil

Understood. One last question on Jardiance, empagliflozin.

I believe we are one of the first to file. Is it going to be any materially meaningful product for us, even if it is a couple of years out?

Sharvil Patel

I would say overall we had a good success in terms of first to file and also settlement. We do see a lot of good pipeline of products coming through, including empa, but also importantly even in the year gone by, we have filed almost four to five again sole exclusive first to files.

It's probably been one of the best years for Zydus in terms of sole first to file opportunities that we've seen. We are quite excited with the prospect of future pipeline that we'll get to launch.

Bino Pathiparampil

Got it. Sorry, I didn't understand.

Is empa going to be a sole opportunity for you, or will it be shared?

Sharvil Patel

No, empa is not a sole, but, as I said, beyond that also we have filed at least four sole first to files this year.

Bino Pathiparampil

Understood. Okay.

Thanks. I'll join back the queue.

Operator

Thank you. The next question is from Nitin Agarwal.

Hi, Nitin. Can you hear us?

Nitin Agarwal

Hello.

Arvind Bothra

We move on. Nitin, can you hear us?

Nitin Agarwal

Yeah. I can hear you.

I was just saying that in the US, 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 US business growth for the interim next three to four quarters?

Sharvil Patel

We have guided that we will still see growth in the US in the coming year. In fact, even in FY26, at least the calendar year, we have seen an 11% volume growth for a US business, while the market has grown at 1%.

We have grown at 11%-plus percent on the volumes. Which is also helping.

Both the base business is robustly growing. We still continue to launch meaningfully a lot of products in the US and will continue in this year also.

Then, as I said, as the year comes nearer to the end, we'll have some exclusive launch also. We'll see a good growth continue in the US generics business.

Nitin Agarwal

Sir. Thank you so much.

Operator

Thank you. The next question is from Surya Patra.

Surya Patra

Yeah. Thank you for this opportunity, sir.

I will just extend my question on the US 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 years?

When we talk about the specialty opportunities, we have already three this rare disease products also that is there in the US market already. Considering all that, how big the specialty contribution would be to the US, and how significantly it can ramp it up, what do you think?

What other triggers that you find for the US growth for the next two years?

Sharvil Patel

In the medium term in the next two years, obviously we have very important launches, four to five sizable launches that we'll get to see, and some where we are sole exclusive in the market. Beyond that, obviously we have plans to launch 40 to 45-plus products in FY27 and will continue to have a large growth trajectory going forward as well.

Then the whole 505(b)(2) franchise of liquids as well as the supportive onco product like Bizre, as I said, we hope to file one more soon with a partner and also potentially launch it in a year's time. All of that will lead to adding further value on that.

We just licensed ranibizumab also biosimilar. We also see that in the second half of the year launch of that.

Overall, I would say the specialty/505(b)(2) pipeline will grow very well with biosimilars entering also. Beyond that, obviously Sentynl has three just launched Zycubo, and we'll see a good year for Sentynl in the coming year, so that part of the specialty business will also meaningfully track.

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.

Surya Patra

Okay. Here price erosion is single digit.

That is how one should consider, sir, when you say 11% volume growth?

Sharvil Patel

Yeah. Other than lenalidomide and others, single digit.

Sorry, can you repeat that?

Surya Patra

When you say 11% kind of volume growth, price erosion should be single digit. That is what one should believe?

Sharvil Patel

It would be.

Surya Patra

Okay. My second question is on the margin scenario going ahead.

Couple of factors that is likely to play out, obviously the lenalidomide factor, secondly, 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, Amplitude as well as 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 a kind of a margin what the acquisition should be having. Given that, there is a kind of a visible pressure on the margin on the subsequent quarters it looks like.

Any sense or any commentary on that,

Sharvil Patel

sir? I think obviously we have had exceptionally high margin, much significantly higher than even any industry margin that has existed in FY26.

If you look at going forward lenalidomide that we will see. In quarter four, which we'll probably see very little growth or no sale also on lenalidomide, we still expect a 23%-plus margin.

I think while 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, it's near to it, but similar margin. We will still track at 23%-plus margin in the quarter four.

Surya Patra

Okay. Sir, just one clarification, sir.

This Amplitude, what is the like-to-like growth that we could have seen in this quarter? Whether the MedTech revenue what we have reported, it is purely Amplitude, or something else also that is included there?

Sharvil Patel

It's that plus some cardiovascular sales as well.

Surya Patra

Okay. What was the like-to-like growth in the Amplitude, sir?

Sharvil Patel

It's high single-digit growth for the like-to-like business.

Surya Patra

Sure, sir. Yeah.

Thank you. Wish you all the best.

Operator

Thank you. The next follow-up question is from Bino.

Bino Pathiparampil

Hi. Thanks again.

Just following up on the product palbociclib which we have in-licensed, is it as of today an FY27 opportunity or an FY28 opportunity?

Sharvil Patel

The first part, I missed when you said licensed.

Bino Pathiparampil

Palbociclib which we have in-licensed, I believe there was some patent and pediatric extension which was awaited. As of now, would be an FY27 opportunity or FY28 opportunity?

Sharvil Patel

That we can't answer because if the pediatric exclusivity is granted, then it will be FY28, otherwise it could be FY27.

Bino Pathiparampil

Okay. Riociguat continues to be FY27 opportunity, right?

Sharvil Patel

Yes.

Bino Pathiparampil

Got it. One last question on this product, enzalutamide, Xtandi, is that a material product for us whenever it comes?

Sharvil Patel

I'll ask Arvind to come back to you on that specific product, because directly, I can't answer that because I don't have recollect. Yeah.

Bino Pathiparampil

Thank you.

Sharvil Patel

Thank you.

Arvind Bothra

Thank you. The next follow-up question is from Saion Mukherjee.

Saion Mukherjee

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 saroglitazar, Desidustat, and your biosimilar portfolio? In that context, how should we think about these products going because I think this year has been a good step-up, particularly for Desidustat.

Where do you see these brands, the peak sales potential, particularly for Saro and Desidustat? Are there any patent risks that we need to be worried about on these products for the next three, four years?

Sharvil Patel

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%-plus percent.

Also our growth booster brands, which are those 30-odd brands that we focus on, are also growing at greater than 13%. I would say overall the portfolio is tracking very well.

As these products scale up like Saro, Desi, also our biologics business also, we'll see a better trajectory on that. Saro is already overall a 450-plus crore franchise as a molecule.

We see the very significant strong growth continuing for the franchise. We're quite bullish on Saro.

Also Desi similarly we only see stronger traction going forward. I think from that point of view, yeah, the patented molecules are doing very well.

The biologics are also doing extremely well. As I said, even beyond that, our growth booster brands, which are beyond these, are also tracking significantly better than market.

Truly vaccines and other business also, which is separate, yeah.

Saion Mukherjee

Okay. Sir, just one mentioned about some tender wins on vaccines.

How large are this potential, and when should we pencil in these revenues in our model?

Sharvil Patel

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 FY26 the MR tender, which is a 100-plus crore already opportunity that we have realized on a single product.

Our also 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. The rabies vaccines have done extremely well in the Indian market as also with prequalification.

I think as we get to the global tenders, obviously we're starting off on some of them, the initial starts are small. As we get into the second year, third year, the supplies go up.

As I said, I a very strong value out of vaccines. In the next three to four years, we want to have a 1,000-crore-plus business on vaccines for sure, and that's what we are conservatively aiming

Saion Mukherjee

for. Okay.

Thanks a lot.

Operator

Thank you. The next question is from Bansi Desai.

Bansi Desai

Hi. Thanks for the opportunity.

Sharvil, my question to you is on our M&A strategy. You had earlier outlined that you would want to scale up US specialty through inorganic opportunities.

Therefore, if you could provide an update on the progress of this strategy and the nature of assets that you are prioritizing in terms of therapy areas or commercial stage of these assets?

Sharvil Patel

In the US, as I said, yes, we are looking to how do we diversify and have more specialty-driven business. 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.

We do see traction to being able to find more of these opportunities in the next year or two. We hope to at least get one or two deals almost every year.

That's one BD&L opportunity and licensing to 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're 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 US market, we are excited with that opportunity also as move forward.

Overall, yes, the specialty business will continue to grow. 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, but it'll be in the liver, hepato, gastro space, adjacency, or at least any niche adjacencies in major diseases. It will be mostly specialty-driven portfolio acquisition if we are able to do.

Bansi Desai

Any plans to augment this via assets which have commercial infrastructure or capabilities around that?

Sharvil Patel

Yes. That is also a way we're looking at it.

Bansi Desai

All right. My second question is on India, given our innovative brands are doing well, our chronic mix is going up, we will also see potentially GLP-1 launches.

Fair to assume that our India business should track that double-digit growth for the next two, three years based on the portfolio that we have today?

Sharvil Patel

Yes, I think we have a strong momentum for our innovative brands. Also, we will have sema launch as well as many other interesting first day one launches in the market.

Also future more proprietary new drugs to come. We are quite bullish on double-digit growth for India.

Bansi Desai

All right. Thank you.

Arvind Bothra

Thank you. The next question from Devang Sarawgi.

Devang Sarawgi

Good morning, sir.

Sharvil Patel

Good morning.

Devang Sarawgi

We secured shareholder approval for 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?

Sharvil Patel

It is mostly contingent on if we get to see any major opportunity. As I said, our internal accruals and cash flows are sufficient for us to continue to do what we need to do without a fundraise.

Fundraise is an enabling provision for us to use if we feel that we need to, provided we can see any meaningful acquisition.

Devang Sarawgi

Secondly, if you can provide any clarity for mirabegron litigation, what should we assess the maximum risk limit for the product?

Sharvil Patel

As we speak, we are in litigation, I don't think we'll be able to make any comments for now.

Devang Sarawgi

Okay. Thank you.

Sharvil Patel

Thank you.

Devang Sarawgi

Thank you.

Arvind Bothra

The next question is a follow-up from Surya Patra. Hi, Surya.

Requesting you to unmute and ask your question.

Surya Patra

Yeah. Thank you, sir.

Just wanted to understand how important this Myriad Genetic collaboration be for us, and what is the opportunity that we are trying to target here?

Sharvil Patel

We had earlier already licensed one opportunity in the liquid biopsy space with Guardant, and that's tracking extremely well in India. 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 genetic conditions related to cancer and others. 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 CanAssist and the liquid biopsy business, and this would significantly add further opportunity for the company. Beyond that, obviously, we create a very strong patient angle to how we manage the whole ecosystem for cancer for both the oncologist as well as the cancer patient in terms of giving them additional opportunities for them to test and early diagnose.

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.

Surya Patra

Sure, sir. 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. If you can clarify, sir, because you have got the approval from the CDSCO about your generic version.

What strategy that you are likely to play here, and what is your manufacturing arrangements or partnership arrangement for GLP-1?

Sharvil Patel

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. We are definitely in the first wave.

We already have marketing authorizations and all of that. That is happening and that will be with our novel formulation.

In terms of other markets, as I said, we are saying we are not in the first wave when it comes to other markets. Probably in the next 12 months, we will enter those markets also.

In India, definitely we will be on day one post IP.

Surya Patra

What is the novelty that we are talking about here?

Sharvil Patel

We have a new formulation where 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 don't need to make any changes from the initial dosing to the higher dosing with the same device it continues. It'll definitely add significant ease of use for the patient, much less complexity for patients to learn two devices.

Also, the supply chain-wise becomes much easier because you're not carrying two different devices for early first four weeks and then the future. All of that is going to lead to very meaningful, I would say, patient burden being lowered in terms of understanding and use and carrying, and also in terms of supply chain, also convenience of dosing.

Surya Patra

Okay. Just last one point, sir.

On the finance cost side, we are having the cash balance as well as the debt. That's why the interest cost is seeing a kind of a sequential rise.

Generally, what is a kind of a thought process here going when we think about FY27 and beyond?

Sharvil Patel

A net debt basis, we are 3,000 crores of debt as of now, and I would say that's because of obviously the large acquisitions that we have done recently. I think we are more than comfortable in terms of our net debt position.

Surya Patra

Okay. Thank you, sir.

Wish you all the best.

Sharvil Patel

Thank you.

Operator

Thank you. The next question is from Gaurav Tinani.

Gaurav Tinani

Hi. Good morning.

Sir, first questions on the biosimilar strategy. Firstly, on ranibizumab, just wanted to understand the landscape right now.

I believe 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.

Do we see the commercial landscape still attractive, and do we see this as Sandoz, when can they re-enter the market, and when can Zydus enter the market here, please?

Sharvil Patel

As I said, we hope to enter in the second half of the year. That's where we are planning for launch.

There is definitely a opportunity where there is not enough biosimilars available on ranibizumab in the market, and we see that as an opportunity.

Gaurav Tinani

Sandoz had almost a 48% share, and they still withdrew from the market. Now, any read-through from there, why did they withdraw from the market?

Now, we've also taken Formycon's product. Why did Sandoz withdraw the market?

Sharvil Patel

No, I don't have regulatory reason, maybe a commercial reason, I don't know.

Gaurav Tinani

Got it. Okay.

Secondly, for biosimilar Keytruda, the next clinical milestone in terms of the Phase 1 study completing, when can we expect the readouts for that? Do you see that in H1 of this calendar year, H1 of CY2026?

You

Sharvil Patel

we will see it in this year, I mean this calendar year.

Gaurav Tinani

This calendar year. Okay.

Got it. If the study is successful, in the press release, we've also mentioned that we can use Agenus' 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 read-out on that, please?

Sharvil Patel

No, currently 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 will use our US facility.

Currently, the BLA application will be submitted through the Europeans. Right.

Gaurav Tinani

Got it. Sir, last question.

I think we've guided for 23%-plus margins in Q4 of this year. With next year US growing, emerging markets growing 20%-plus, India also going in double digits, any guidance for EBITDA margins for next year?

Sharvil Patel

I think, as I said, the best is 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 more nearer-term guidance. 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.

Gaurav Tinani

Sir. Thank you.

All the best.

Operator

Thank you. We wait for a few minutes until the queue assembles.

Requesting participants to please raise their hand from participant tab on the screen to ask question. As there are no further questions, we take a follow-up question from Gaurav Tinani.

Gaurav Tinani

Yeah. Sorry.

One last question. As we are building in a slight ramp-up in other expenses ex-R&D, which we guided earlier in this call, what would be the key levers for this higher opex spend?

Would there be a field force dedicated for GLP? Would there be a field force for biosimilars driving this, or would there be marketing spend in Comfort Click, or additional field force in Amplitude driving this?

Any read-through for that, please?

Sharvil Patel

No, none of those. It's the acquisitions that have led to obviously some of the higher base being created.

There is no addition of field forces in the current acquisitions or the current businesses. Future, Saro will have a commercial team, which is not baked in yet.

Gaurav Tinani

The biosimilars field force for ranibizumab would be the same which we use for the 505(b)(2) products?

Sharvil Patel

Yeah. It's largely the same number of people we have.

We'll reorganize a little bit.

Gaurav Tinani

Sir. Got it.

Thank you.

Sharvil Patel

Thank you. Thank

Arvind Bothra

you. Yes, sir.

We can have our closing remarks, and then close the call.

Sharvil Patel

Thank you. I think as the organizer said there are no further questions.

Thank you, everyone, and we look forward to seeing you in the next quarter.

Operator

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.

Arvind Bothra

Thank you.