Ladies and gentlemen, good day and welcome to Zydus Lifesciences earnings conference call for the fourth quarter FY 2026. I now hand over the conference to Mr. Ganesh Nayak, Director at Zydus Lifesciences. Thank you, and over to you, sir.
Hello.
Yes, sir.
We couldn't hear the last part. Could you say it?
Please note this conference is being recorded. I now hand over the conference to Mr. Ganesh Nayak, Director at Zydus Lifesciences. Thank you, and over to you, sir.
Good evening, ladies and gentlemen. It's my pleasure to welcome you all to our post-results teleconference for the fourth quarter and the financial year ended March 31, 2026. For today's call, we have with us Dr. Sharvil Patel, Managing Director, Mr. Tushar Shroff, CFO, Mr. Arvind Bothra, Head of Investor Relations, and Mr. Alok Garg from the Managing Director's office. To begin with, let me give you an overview of the performance for the year. I'm happy to inform you that we have ended the fiscal 2026 on a strong note. Overall, we delivered healthy double-digit growth during the year ahead of our expectations. Even after adjusting for acquisitions, the base business grew in double digits. This reflects the underlying strength of our operations. On the profitability front, we surpassed our expectations, achieving the highest ever operating profit as well as margins during the year.
A strong product mix combined with operating leverage and Forex tailwinds propelled profitability. In the pharma space, our U.S. formulations business grew on a higher base of the previous year despite the increased competitive intensity in key products. Base business volume expansion, new launches, and sustained traction in the specialty portfolio drove growth during the year. Our branded formulations business in India outpaced the market with strong double-digit growth, supported by healthy volumes and new product introductions. Our international markets business spanning emerging markets and Europe sustained strong momentum with demand-led growth across geographies. We expanded into the international consumer wellness space by acquiring and integrating U.K.-based Comfort Click Limited. This move establishes our footprint across the U.K., E.U., and the U.S. It significantly strengthens our presence in the high-growth pediatric wellness and animal health.
On the medical devices front, we took significant strategic steps as we establish it as one of the three business verticals for Zydus. We acquired the French orthopedic firm Amplitude Surgical and entered the nephrology and cardiovascular devices space. These moves position us well for the next phase of our growth. We are also accelerating our digital transformation. Advanced analytics, automation, and AI are now embedded into our operations, improving efficiency and the way we serve our stakeholders. With that, let me take you through the financial numbers for the year gone by. We recorded consolidated revenues of INR 271.5 billion, up 17% on a year-on-year basis. The business delivered strong operating performance with an EBITDA margin of 31.2%, which is an improvement of 80 basis points over the high base of the previous year.
Consequently, the consolidated EBITDA for the year grew by 20% to INR 84.8 billion. Net profit adjusted for exceptional items for the year was INR 54.6 billion, up 15%. Thanks to our strong financial performance and disciplined financial management, we kept our net debt to EBITDA ratio comfortably within the benchmark levels, even as we pursued several inorganic growth opportunities during the year. Our net debt to EBITDA ratio stood at 0.5 times as on the 31st of March 2026. Coming to our quarterly financial performance, we ended the year on a strong trajectory. Our consolidated revenues for the quarter stood at INR 75.9 billion, up 16% on a year-on-year and 11% on a quarter-on-quarter basis.
Our operating profitability continued to improve with an EBITDA margin of 33.7%, which is an improvement of 110 basis points on a year-on-year and 720 basis points on a quarter-on-quarter basis. EBITA for the quarter stood at INR 25.6 billion, up 20% on a year-on-year and 41% on a sequential basis. Net profit for the quarter, adjusted for the exceptional expense, was INR 15.9 billion, up 15% on a year-on-year and 43% on a quarter-on-quarter basis. Let me take you through the operating highlights for the fourth quarter of FY 2026 for our key business segments. In the pharmaceutical space, North American business comprising of the U.S. and Canada registered revenues of INR 29.5 billion during the quarter, up 5% quarter-on-quarter.
Growth during the quarter was driven by volume expansion in the base business, new product launches, and sustained traction in the specialty and rare disease portfolio. On the U.S. generics front, we filed 3 ANDAs, received 9 approvals, and launched 6 new products during the quarter. On the U.S. specialty front, in the month of April 2026, we filed 2 new product dossiers through the 505(b)(2) route, thereby bolstering our pipeline. In the orphan and rare disease space, we launched ZYCUBO, which is copper histidinate, for the treatment of Menkes disease, which is an ultra-rare disease. With this launch, we now have 3 rare disease products marketed by Sentynl. In India, our branded business formulations business sustained its growth trajectory with a robust 15% year-on-year growth, outperforming the market growth for yet another quarter.
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, and in the super specialty areas of oncology and nephrology. On the super specialty front, we continue to retain leadership position in the oncology therapy. Contribution of the chronic portfolio has increased consistently over the last several years and stood at 46.3% as per IQVIA MAT March 2026, which is an improvement of 620 basis points over the last 3 years. During the quarter, we launched the world's first biosimilar of nivolumab under the brand name Tishtha, reinforcing our growing capability in advanced biologics and immuno-oncology.
This immunotherapy will reduce the treatment burden by making it accessible at approximately 1/4 the cost of the reference drug, and is likely to benefit over 500,000 patients. We also launched the country's first indigenously developed biosimilar of aflibercept 2 milligrams under the brand name Anyra for advancing ophthalmic care. During the quarter, we launched semaglutide injection under the brand name Semaglin, MASHEMA, and Altame. Licensing and supply agreements with Lupin and Torrent Pharma for co-marketing in India. Our international markets formulations business continued to deliver strong double-digit growth with revenues of INR 8 billion, up 45% year-on-year. The growth was broad-based across regions with strong demand-driven performance in both the emerging markets and Europe, supported by focused execution. Our consumer wellness business recorded revenues of INR 14.6 billion, up 61% year-on-year.
In the domestic business, we retained leadership position across most product categories that we operate in. Skin and hair care brands and food and nutrition brands registered growth of 39.7% and 9.4% respectively, whereas seasonal brands declined by 9.8%. International business, including the Comfort Click, delivered a like-to-like growth of 31.4%. In the medical devices space, the business performed in line with expectations and registered revenues of INR 3.3 billion. We expect the business to deliver steady performance in the coming quarters. This will be driven by expanding our geographic presence to capture newer markets, unlocking cost synergies over time to improve profitability, and leveraging our technology-driven advanced portfolio to deliver superior patient health outcomes.
On the operations front, our oncology injectable manufacturing facility located in the Ahmedabad SEZ received an EIR, Establishment Inspection Report, for the pre-approval inspection conducted in the month of November 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. Good evening, ladies and gentlemen. It is our pleasure to have you all here today on the call. Fiscal 2026 was remarkable, with robust double-digit growth and record operating profitability. Even excluding inorganic moves, the base business delivered strong double-digit growth, reflecting the strength of our portfolio, our pipeline of innovation, and the resilient supply chain and strong execution capabilities. Over the last couple of years, we undertook several inorganic initiatives to acquire new capabilities to expand our offerings and enable the patients to fulfill their diverse healthcare needs. These organic moves, coupled with various business development initiatives, have complemented the existing business well and will be the key pillars for sustained long-term growth going forward.
In the U.S. market, we ranked amongst the top three players in the generic space, backed by a rich and differentiated products portfolio built in-house as well as through partnerships. As we pivot towards specialty, we are driving growth through multiple levers. Our 505(b)(2) pipeline, built via in-house development partnerships and LiqMeds' acquisition, is expanding steadily. Sentynl pediatric rare disease portfolio is broadening access to innovative therapies. In biosimilars, we have in-licensed two large molecules and strengthened capabilities with the newly acquired U.S. manufacturing facilities. We shall maximize the utilization of these facilities through continued BOT/BAL supply to Agenus and onboarding of new partners. Together, these initiatives position us strongly to accelerate our specialty play. We are accelerating our U.S. specialty oncology strategy through the proposed acquisition of Assertio Holdings.
This is a pivotal move to provide us with an immediate high-scale commercial platform in the oncology supportive care. At the heart of the deal is ROLVEDON, a U.S. FDA-approved long-acting biologic that anchors our portfolio. By leveraging Assertio's deep oncology relationships and the strong share in Medicare Part B accounts, we are now not just expanding our footprint, we are building a highly differentiated, high-margin specialty oncology business in the U.S. that is accretive and establishes a strong platform for the future. The India formulation business remains a compelling growth story for us. Our branded portfolio once again outpaced the market with strong double-digit growth, driven by consistent strength of our brands, sharper therapy focus, and a pipeline built around differentiation and unmet needs. Years of these deliberate strategic interventions have created a compounding effect, broadening our reach, deepening our customer trust, and accelerating our commercial momentum.
What makes this especially meaningful is that our engagement extends well beyond the point of prescription. Through patient support programs and value-added services, we remain a dependable partner at every step of a patient's healthcare journey. Our international markets formulations business spanning emerging markets and Europe have consistently delivered strong double-digit growth over the past several quarters. In emerging markets, we are driving performance through a therapy-led approach, tailoring solutions to local needs and building a more agile, market-responsive portfolio. In Europe, our focus is on expanding portfolio breadth and strengthening market coverage, positioning us to capture incremental growth and deliver enhanced value to our customers. Our consumer wellness business continues to drive our growth, fueled by category-led leading brands and a shift towards premiumization. We are aggressively expanding into nutrition and vitamins, minerals, and supplements space while scaling our digital footprint through Comfort Click acquisition.
Our focus remains on innovation and digital-first segments, ensuring we build a future-ready portfolio that delivers consistent results for our stakeholders. In our MedTech business, we are strategically focused on 3 critical areas, cardiology, nephrology, and orthopedics, to build strong growth engines for growth. With Amplitude advanced orthopedic portfolio bringing cutting-edge innovations to patients, surgeons, and healthcare facilities worldwide. In cardiology, we are broadening our offerings to meet evolving clinical needs, while in nephrology, we are establishing a high-end dialyzer membrane facility to address the global rising demand. These initiatives underscores our commitment to deliver superior patient outcomes and build a strong, sustainable growth engine for the future. With this, let me share some material developments on the innovation front during the quarter.
Our Desidustat tablets, which we licensed to China Medical System Holdings in 2020, has now received approval from the Chinese regulators for the treatment of renal anemia. This marks a significant milestone for us as an approval has come in China, the second-largest pharmaceutical market globally, reinforcing our global potential of our innovation pipeline. The U.S. FDA has also granted orphan drug designation status to Desidustat for the treatment of sickle cell disease during the quarter. Our novel anti-malarial candidate, Zintrodiazine, received the approval from the DCGI to conduct two phase III clinical trials in patients with uncomplicated malaria due to both Plasmodium falciparum and Plasmodium vivax in India. In the biotech R&D space, we initiated a phase III trial of a second biosimilar ADC in India.
On the novel biologics front, we initiated a phase I clinical trial for one new candidate and pre-clinical studies for another candidate in India during the quarter. On the global development front, the in-licensed pembrolizumab biosimilar candidate, FYB206, successfully completed the clinical development, marking a major step towards U.S. FDA filing. On the FYB202 front, we entered into an agreement with PRG S&T, a Korean company specializing in the development of medicines for rare genetic diseases, to license its investigational molecule Progerinin SLC-D011 for Hutchinson-Gilford progeria syndrome. We shall acquire full rights to this drug candidate upon achieving certain milestones, making it our second therapy intended for the treatment of HGPS. Thank you, and we now will 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 2 questions and then return to the queue for more questions. Please raise your hand from the participant tab on the screen to ask the questions. The first question is from Kunal Dhamesha.
Hi, this is Kunal from Macquarie. Thanks for taking my question and congratulations on good set of numbers. First one for you, Sharvilbhai. You know, FY 2026 has been exceptionally strong for us. You know, where do you see FY 2027, you know, from the growth perspective as well as the profitability perspective? Any outlook here would be helpful.
Thank you, Kunal. I think on We are very happy with the 2026 performance. I think looking forward, I think on the consolidated revenue, we still continue to see high teens growth for FY 2027. We do expect that in spite of a high base of FY 2026 for North America, we will still see a growth, single-digit growth in the North American business aided by the portfolio. India, we have now consistently demonstrated better than market growth, and we are thinking we will outperform the market by 200-400 basis points versus the current IPM. On the international markets, we have seen very significant 40+% compound, I mean, growth for the year and 45% for the quarter, and we see that momentum continuing also in the current year.
On the consumer side also, we see a good momentum on double-digit growth. Overall on the revenue side, we see a strong momentum for the organization. On the margins front, we ended this quarter at around 25 point, around close to 26%. I think FY 2027, looking at competition, also REVLIMID competition, mirabegron competition, expenses related to Saro launch, we are expecting margins in excess of 24%.
Sure.
EBITDA margins.
Sure.
This still assumes an 8%+ R&D expense.
Okay. Perfect. Sharvil Patel, on the specialty front, you know, now we have almost 3 molecules, you know, especially the rare disease molecule in the market through Sentynl. We also have kind of FYB 2 portfolio through ZYCUBO, right? If you put all these together, which are, let's say, you know, high entry barrier kind of molecule, what would be the current contribution of this portfolio? With our pipeline that we have, Saroglitazar for PBC, Desidustat in China, where do we see this contribution going over the next 3-4 years for our overall business?
Currently, see, I think we are building on the 3 legs that you just mentioned. We have Sentynl, which has now 3 approved drugs. With this, it has become, you know, it has broken even and it started gonna make profits going forward. I think with adding more portfolio to that business, we would see that business scale up. This will be high profitable businesses, but not high value-driven businesses. On the FYB202, we have now today obviously sitagliptin franchise. The scale up is more getting along with our oncologic supportive care through the in-licensing that we did on Besre.
With, also the LiqMeds portfolio scaling up, I think this will become a more faster scalable business very soon, and also very profitable as we are able to launch these products, including ranibizumab, by end of the year. We would see, I think, 2027 onwards, good momentum and size for this business. This is just the beginning, I would say, this year. FY 2028 would be seeing a stronger momentum, but this year also will be quite good growth for these businesses. Finally, Saro, we are still in the early commercialization, in the sense of hiring teams and preparing for the pre-launch activity. As we come closer to approval and launch, we can share more details.
Overall, yes, our vision is that our non-generic specialty portfolio will be the meaningful growth driver for the organization over the next three to five years.
Sure. That is great. Lastly, on this Assertio, you know, potential acquisition of Assertio, how that kind of fits into, you know, all these three growth driver. The product ROLVEDON, we have seen it's primarily for the onco supportive care, primarily competing with pegfilgrastim, if I'm correct. Right, how does that, you know, within that space, that product, kind of how is it positioned? I believe pegfilgrastim also has an device which kind of lets people administer the therapy at home rather than spending another day in clinic. How ROLVEDON compares there as well as on some bit of clinical efficacy and safety side, for us to kind of, you know, be more positive and, I mean, how are you seeing positioning this molecule?
We already have a supportive oncology team which currently markets Besre. We have also partnered with RK for one more future supportive FYB202, which has been filed, and we hope in the next 9-12 months we will see the approval and launch. This again adds to the portfolio of this team for launch. We have already a commercial platform to launch ROLVEDON. Today, you know, we believe it has around a 4% volume share. It has many benefits. One, it's still a novel long-acting GCSF and not a biosimilar. It also can be administered the same day versus the other biosimilars or biologics in the market, so there is a benefit to that.
We see the good momentum, the business tracking, and we are very confident on once the acquisition is closed, how do we integrate it with the business, and scale it up. That's the overall plan with the Currently will be a pipeline of 3. We also have ranibizumab launch coming, and we see also that with the current team and certain resources we can use them also for the scale-up of ranibizumab.
The commercial presence would be leveraged across many fronts, right? Is the way to look at it.
Yes
Assertio presence and
Yes
okay. The 24% plus EBITDA margin guidance bakes in that incremental commercial presence that we are going to build for, let's say, Saro or maybe let's say for Assertio, et cetera, right?
Yes.
Okay.
Assertio we're not building yet.
Okay
Saro is part of our plan. Assertio will not have a cost. I mean, we'll see more synergies versus cost.
Sure. I have more question. I'll join with it. Thank you.
Thank-
Thank you. The next question is from Neha Manpuria.
Yeah, thanks for taking my question. My first question is on the India business. I think you mentioned, you know, 200 to 400 basis points higher growth in India versus the market. I can see that obviously there has been an improvement in growth in the last few quarters for Zydus. Could you talk a little bit about, you know, what gives you the confidence on maintaining this outperformance? Incrementally, where would you see more growth coming from in India? Second, just a related question on India. Do you think we need to make more investment in India, either through MR expansion or probably acquiring more products to boost growth? You know, you think the investment in place and therefore this growth should drive margin expansion for the business?
Currently, we don't see any further rep investment in the short term. I think the growth, we are confident on the growth driven by the innovative portfolio, which is scaling up very meaningfully. Our focus on the growth booster brands that we have been speaking for the last 2 years now, which is delivering better growths now. Also we are seeing a very strong traction on our key therapies with the launches and monetization of our portfolio on biosimilars and also the new launches that we have done. Continuously we are improving our chronic share consistently over the last few years, and that is also aiding to better mix in terms of the business. I would say it's an all-around performance with the many things.
obviously innovation-led also, but also focus on brand building on our core brands is helping us succeed.
Understood. Second, you mentioned about the Saro investment. Could you provide some color on what you think the investment for Saro would be in FY 2027 to build out the commercial? You know, given that we've also a second, another unrelated question. Given the investments that we've made in different areas, you know, CDMO, MedTech, specialty business now with, you know, Assertio, could you provide us some, you know, milestones that we need to watch to give us confidence on when we should see this business becoming more meaningful, you know, to Zydus as a whole?
On Saro, we, for this year, we'll have an additional INR 7 million kind of investment on the commercialization part on Saro. That is what we have factored in.
Sorry, sir, I missed that number. What did you say? Apologies, I missed that number.
Seventy.
Seventy.
Seven-zero.
Okay. Thank you.
With respect to Assertio, I mean, it's still a we still have to close on the deal, but we see it being an accretive deal to the organization. That's what we can say now.
Post, I think, closure, we can talk about more.
For the other businesses, sir?
Sorry?
You know, we've done like CDMO, we've done MedTech. There's obviously, you know, Comfort Click. You know, so for these, what do you think would be a good inflection point for us to start seeing meaningful contribution to Zydus's performance? For MedTech, yes, we are seeing Amplitude already contribute. Do you think?
You know, the scale-up in this business, in terms of what we have envisioned would take us a couple of years, or do you think that could be witnessed in 2027, 2028?
The medical devices business is a platform build that we are going through, so it'll take at least 3 to 4 years before we see a strong momentum. I think we would see improvement of cost and profitability as we build more synergies. On the Comfort Click business is already a strong growth business. For the last 6 months post-acquisition it has delivered on its numbers. It is already EPS accretive in this fourth quarter, and going forward also will be EPS accretive. I think that's on track. It's a steady growing, fast-growing business and is getting integrated well with the organization. On the Agenus acquisition of the manufacturing on Zylidac Bio, again, that's beginning, I would say, we would need the next 2 years to build capabilities.
The What it gets is obviously immediate supply for the BOT/BAL to Agenus, which will continue, and we are seeing good traction there. But as we add more partnerships and maybe more products, we would see better utilization of the facility over the next 3 years. But it will take at least next 3 years before we see that facility being well utilized.
This balstilimab contribution isn't very meaningful at the moment, right, sir? It's just incremental, but it's not like a big revenue contributor. That would be a fair assumption?
It's not gonna be significant, but it's around $10 million-$15 million.
Okay. Got it.
revenue.
All right. Thank you so much, sir.
Thank you.
Thank you. The next question is from Harith Ahamed.
Hi. Hope I'm audible.
Yes.
My first question is on semaglutide, sir. We are guided for a 4Q 2026 filing in previous indication. Can you give an update on the status of that? If it's filed, do we have a goal date from the FDA?
In a new NDA filing, once the acceptance of the NDA happens, we can give you the goal date. I think we will update you once we have acceptance of the NDA.
It's filed, but we are awaiting the acceptance?
Yeah.
That's-
await the acceptance of the NDA, which is the more important milestone.
Okay. Got it, sir. You know, semaglutide in India, can you give us a sense of the rationale for our out-licensing strategy here to Lupin and Torrent, given we have a very differentiated reusable pen device? What was the thought process behind going along with our own launch, licensing it out to partners? From a realization standpoint, per device, how different is our own sales versus, you know, sales through partners?
I think we have launched a novel formulation on sema. I think it is obviously, as Zydus alone, we don't cover each and every doctor and specialty. Also, this being a highly competitive product with the multiple launches, we believe that the best strategy would be to launch with more players to create more share of voice and more impact for the new formulation with the customers. I think that strategy has worked very well. I think we are now number two in terms of share, and closely followed by Lupin, and Torrent also has gained strong share. I think it was a good choice on partners. Together we control a very meaningful part of the market share on semaglutide, which is also very important, and I think it'll only grow from strength to strength there.
What we have been able to demonstrate is a very reliable supply, very strong product with a highly reliable pen, which has been the challenge in the market. First to market was also the big success for the U.S. and the companies that launched with us. We do see that this strategy of co-partnering has helped in terms of gaining strong market share and share of voice, and we hope this momentum will continue.
Okay. lastly on ROLVEDON, just to clarify, did you mention that the dosing schedule for this product is different versus pegfilgrastim, or is it the same?
I think the main thing is it can be co-administered on the same day, which is one of the benefits versus.
Okay. Next day for pegfilgrastim. Okay. Got it, sir. Thanks for taking my question.
Thank you. The next question is from Saurabh Mukherjea.
Hi, good evening, and congratulations on another good quarter. I have a question on R&D expenses, which have ramped up quite rapidly. It appears that, you know, almost INR 700 crore of quarterly run rate, you know, you have, which is probably one of the highest in the industry here. Is it all organically driven? Because if I look at the employee expense within R&D, that seemed to have, you know, increased at a much more moderate pace. How should we think about the INR 700 crores? Like, what are the key investments? If you can just split it up into generics, biologics, vaccines and innovation.
Sure. I think, yes, we believe our R&D is a very critical part for our future growth and profitability, and we have been consistently investing in that. Obviously, we have a little bit of lumpiness during different quarters. As we are guiding forward, we are seeing around 8% of FY 2027 is our current expectation on R&D. The breakup is around for the last year is around 50% was on generics and value-added generics.
The rest, 43%, 40-plus % was on NCE, biologics and vaccines. That has been generally the breakup of R&D. As we move forward, we would probably see a little bit higher uptick on the NCEs and biologics. Probably a similar kind of number on, in terms of absolute number on the generic side.
Okay, sir. The other one is on, you know, SEMA, where, if you can give some color based on your initial experience in India, how large you think it can be for Zydus over the next 2, 3 years. The device and pen that you have, is there something you would like to do even in other emerging markets with this product? Or is this largely going to be a India-specific, you know, opportunity?
I think a good beginning to the launch in multiple ways. One is we do combined have one of the strongest market shares in this new device, so there's been good acceptance to the product. We are seeing better forecast than earlier forecasted for all our partners and both Zydus. We are seeing a higher uptick and more confidence, I would say, going forward in terms of growth. Internally, I think we are well poised to sort of do well in the Indian market with both the what, how it has gone and what the orders we have in for the future to manufacture. We have a plan to make sure that this new formulation is available across different markets.
We already have a partnership/registration plan for more than 20-plus markets, which is already ongoing. We are not in the first wave in many of this, but we believe with this differentiation and which will offer a significant cost benefit to the government and the patients. We would see a good momentum for the differentiated formulation in all of these markets. We are going ahead with the filing and obviously partnerships in many multiple markets as we speak.
Okay. Any timeline in terms of launches? like, is it expected in this year or next year?
Depending on the cycle of approval, we could have, I mean, see some in this year or probably some in early next year.
Okay. Just I have one last question from my side. If you can guide for your CapEx number for next year, FY 2027, and also depreciation number is high in the quarter. Is this the number we should bake in on an annual basis going forward?
Yes, we have had an uptick on our capital investment because of multiple initiatives that were taken on expansion. We are thinking in FY 2027 around INR 1,500 crore CapEx number. The quarterly depreciation is around INR 550 crore.
Yeah.
Susan, this also includes, you know, the licensing fees that we have capitalized on the settlement of mirabegron, which will be charged up to 2027, September 2027. It is a limited period charge off that we'll have. Thereafter, there won't be any kind of a cost that will be associated with this depreciation.
Understood. Thank you.
Thank you.
Thank you. The next question is from Surya Patra.
Yeah, thanks for the opportunity, sir, and congratulations for the great set of numbers. I'll start with 2 clarifications that I wanted. First is that whether what really led to this kind of sequential growth in the U.S. business despite REVLIMID not being there. Or if it is there, you can qualify that. Also, what is the kind of like-to-like growth in the U.S. business that we would have seen for the full year FY 2026? That is 1. Another clarification that if you can give that. About this INR 75 million, which is still likely to be seen as a kind of amortization. Beyond that, there is no royalty you charge or anything, right, in case of mirabegron?
There is a royalty charge.
Okay.
You can say.
Hello?
Yes.
Yeah. Are you quantifying the royalty charge, sir? That is one. Secondly, about the U.S. business, the sequential growth, what we have seen, there is a positive surprise considering the no REVLIMID sales sequentially. What has driven that? What is the like-to-like growth in the base business of the U.S. for FY 2026?
I think, as we had stated in the last quarter also that we had very little REVLIMID contribution. I would say there are 2, 3 factors. One is definitely, you know, December end, obviously there is a destocking, we see a higher uptick during the Jan, Feb, March quarter. There is a small incremental benefit that comes out of that. Also I think multiple levers of new products launches, the specialty portfolio scaling up. There have been many levers to good growth. Also, we have said that our base business continues to do healthily, be healthy and co-consolidated share. All of those things have helped us, including some more share on mirabegron. Overall we are around the INR 300 plus million base right now.
Okay. Okay. That means this is a kind of sustainable base even going ahead, since you are talking about a single digit kind of growth for the next year, despite no REVLIMID revenue in the subsequent year.
Yes.
Okay, sir. My second question is about the approach towards the biologics or biosimilar or the CDMO. See, it is a comprehensive approach it looks like from the initiatives that you have taken, either by creating capability in the biosimilar in the initial stage and building the BLAs also, and simultaneously trying to build kind of a CDMO capability in the biologic space. Given or putting all this together, when this vertical is likely to be a kind of a meaningful contributor to Zydus, whether If you can give some sense on that front, then it would be helpful, sir.
Today, the biologics part of our business is very scaled and meaningful contributor to our India business.
It all continues to do extremely well, and we see that meaningful continued scale up. With our partnerships and filings that we have done in the EM markets, we would see over the next 3 years a meaningful scale up of our out licensing and launch of biosimilars in many of these markets, which would add to the overall non-U.S. sort of growth for the biosimilars business. I think in U.S. we have, you know, we have thought it through well. We have been waiting for regulatory framework to change to make it more, you know, beneficial to do the R&D development. Having seen that happen, I think in a very short period, we've been able to license and co-develop and plan our biologics business in the U.S.
We would see, I would say on the next 3 years, important milestone for biologics, but more importantly by 2029, FY 2029, FY 2030, we would see the real scale up on the global biosimilars business.
Next question is about the overall growth. See, in fact, FY 2026 was obviously a kind of a great year supported by mirabegron, REVLIMID, inorganic activities also. For next year, what would be your kind of capital allocation priorities or the investment priorities, whether the momentum on the inorganic growth side that will continue the way that we have seen it was a kind of very heavy inorganic activity year that was during FY 2026. Going ahead for FY 2027, your thought process about it.
Yes, I think You know, what we have been always talking about is building new capabilities when we look at our capital allocation strategy with new platform capabilities or new portfolio. If you see many of the inorganic opportunities that we have looked at, we have seen where we can really build up capabilities and platform. That has been good and going forward also, you know, scaling up our specialty business or with including 505(b)(2) would be obviously one of the important areas that we'll continue to add portfolio to. I think beyond that, I think we are I think have a good R&D pipeline of products to come through, which we are betting on and we are looking it looks exciting for us, we are building towards that.
Mostly it'll be a, you know, bolt-on acquisitions that we could look at from the specialty point of view. Also, potentially, you know, our international business is doing extremely well, you know, as I said, growing at 40 plus %. We are seeing opportunities to also create a strong leg of growth for the international market, so we would continue to look for opportunities there.
Okay. Just last 1 point from my side, sir. See this, about this, Amplitude, we have possibly acquired something else also that, FBC Medical, which is a kind of a distributions setup for those business or it is supposed to add or reduce the cost for the Amplitude. Can you give some more clarity to that? Like what is the current profitability of Amplitude, as for FY 2026 and with the initiative, what is the kind of margin profile that you are thinking about that operation for next year?
Amplitude is a profitable business, upwards of 20%+. The equation we did, you know, there are agents and distributors that you can acquire, so it's a normal course of business that one does it in. It's not really a I mean, in Parle terms, it's an M&A, but it's more about, you know, sales and distribution.
Okay
consolidation that we do.
Okay.
As I said, this business over the next few years, we will look to improve our profitability and growth.
Sure, sir. Yeah, thank you. Wish you all the best.
Thank you.
Thank you. Requesting participants to please identify themselves and restrict to two questions only. The next question is from Devang Saravi.
Hello.
Hello.
My question is on Saroglitazar. Firstly, on PBC, given the trial data is out, in our hands, is company planning to present or publish the PBC clinical trial data at EASL 2026?
Yes.
Secondly, on MASH. According to ClinicalTrials.gov, the phase III clinical trial was completed in October 2025. Could you please share the expected timeline for publishing or presenting the top-line results? Additionally, is company evaluating any out licensing or co-development opportunity with large pharmaceutical company for Saroglitazar in the U.S. MASH market?
Currently, we have in the India large phase IV trial, with a 52-week follow-up for fibrosis is continuing with its recruitment and maybe in the next 2 quarters we'll close on the recruitment. As we get data, we will obviously publish the data on that. With respect to U.S. on PBC, the company has decided to launch the product on its own. We are preparing for a commercialization strategy in U.S. Post a favorable approval in the U.S., we would look to see how do we co-partner or license for Europe and other countries.
Sir, thirdly, when to expect desogestrel launch in China? What is company revenue expectation from this product from Chinese market?
We will hope to see launch in 2nd quarter of the FY 2027 in China. As we get more information on the commercial launch and readiness with the partner, we can talk about it as we get more information.
Lastly, any progress on specialty acquisition for synergizing Saro launch?
No.
Okay. Thank you.
Thank you. Thank you. The next question is from Kunal Dhamesha.
Hi. Thank you for the opportunity again. Just one on the debt side. We are already at more around INR 4,500 crore debt and with the buyback and Assertio acquisition, we would be almost close to around INR 7,000 crore net debt. You know, not consider the cash generation in FY 2027, what is our plan from here? Do we deleverage from here or are we comfortable at this kind of debt level, which would be more like slightly less than 1 time net debt to EBITDA? I would like to hear your thoughts.
We are comfortable around 1 times net debt to EBITDA, so right now on a ongoing basis. We don't see that as major concern. We continue to look for bolt-on acquisition opportunities for our specialty 505(b)(2) franchise. That's what we'll continue to look at and, so yeah, from that point of view, we are currently comfortable with our current financial metrics.
This bolt-on would be on the same strategy of orphan rare disease, right? Is that the way to understand?
Yes.
Okay. Okay. Lastly, you know, on the working capital side, that has also kind of inched up quite a bit from Q1 of FY 2026, through Q4. You know, where do we see that, do we see, you know, working capital, you know, coming back to the older levels?
I think on the overall receivables as well, we are very healthy and probably amongst the best in class when it comes to working capital management in terms of number of days. I don't see that being a major challenge. We continue to always look at ways of improving our health both on receivables and on inventory. We are comfortable where we are, and obviously with acquisitions you would have additional-
Supplemental
capital that would have got added. On the overall health parameters, we are probably amongst the top in terms of health in industry.
Sure. Lastly, on the current geopolitical environment and its impact on the supply chain, what kind of disruption are we witnessing, you know, from the, let's say, fuel availability, to container availability, API prices or raw material prices? How has that been factored into our FY 2027 outlook, along with the currency benefit, which I believe would be also a good positive driver. On the, on the adverse side, the other factor, what are we seeing there and how is it factored into our guidance?
It's very difficult to predict in the next three months and six months, but we are, you know, every day obviously solving for challenges or opportunities that we see. Obviously cost do go up on both freight, on times, on logistics as well as on other things which we have to manage through our better sourcing and better rationalization and cost optimization. We are sort of taking it as it comes. As we see new challenges, we're trying to respond to them and, I think the teams are quite efficient to make sure that they continue to improve on that. Wherever we see opportunity to improve our, you know, margins, we look at that, and that's what we continuously work towards cost efficiencies.
It's difficult to predict what will happen in the next 3-6 months, so we are taking it as it comes.
Sure. At this point, the rupee depreciation, would you say rupee depreciation is enough to cover all the disruption in terms of increased cost side line item?
Yeah, we have a good export base, so obviously rupee depreciation gives us a good cash flow. Yeah. Cash flow.
Sure. Thank you, and all the best.
Thank you.
The next question is from Amish Tiwari.
Hi. My first question is regarding your domestic business. We observe that onco IPM growth is also very strong. In fiscal 2026, the volume growth was pretty strong. Fiscal 2025 was very muted. Also, the pricing growth in both the years is also very strong. Can you just explain what happened in 2026 versus 2025 in which this happened? Did you experience the same phenomena in your onco division as well?
I think that IPM doesn't truly capture the full business specific to oncology. Ipsos is probably a better data source to look at. I would say the growth has been there in the oncology market, which with more government schemes getting implemented, executed and used and as well as obviously we have seen a higher incidence of cancers in the last growth on that. We are seeing a good momentum on that. For Zydus, obviously we have captured a strong share on our launches, pertuzumab, nivolumab, some of the oral oncology drugs where we were first to market. All of that has led to obviously a very strong patient, we have been able to serve a significant number of patients doing so.
With the strong medical support and patient support programs that we are running, we are seeing a very strong, you know, traction on the brands, which has led to a better growth. Now we are the largest Indian oncology player in the market.
Right. The second question I had was the trade generic proposition to your Indian formulation business. How do you see that as a either a long-term opportunity or a long-term threat? Like, if you could just explain how are they taking market share within your line of businesses.
I would say it's neutral to us and our own trade generics is a very small part of our business, so it's more of a cash cow.
Okay. Do you see the others trade generic taking away share over time because the government pushes towards that? I don't know how the customer acceptance or there are any other factors which would limit this market share erosion over long term?
It does always Yes, it is a channel and we have to look at the channel, how it progresses. We do look at that. I think with our innovation pipeline differentiation that we have and a core focus on key brands, I think we can continue to do better than market, from our perspective.
Okay. Just to capture on the first point, the Is the pricing growth also strong in onco line of business or other chronic line of business compared to overall Indian formulation business you have?
I'm sorry, could you repeat the question?
The pricing growth, the year-over-year pricing gains you see in your Indian-
No, pricing generally deflates. Prices goes down, not doesn't go up.
Okay. Okay, great. Thank you.
There's a faster volume growth than value led growth.
Okay. Thank you.
Thank you. Thank you very much to the management team.
Okay.
Ladies and gentlemen,
I think, you can, still, if there are people in QIC, you can still take a few more questions, please.
Okay. The next question is from Saion Mukherjee.
Yeah. Thanks for the follow-up. Two specific questions, Dr. Sharvil, if you can answer. One is, you know, the biosimilar business size today in India primarily, how large is that? If you can share that. The second one, I was wondering if you can talk about out of the $1.2 billion U.S. revenues, if you add all the specialty, rare disease plus 505(b)(2), how large is the portfolio currently?
As I said on the specialty, still in early stages, so it's not meaningfully very large. We see that scaling up over the next 3 years. On the oncology, it's obviously become a very large integral part of our business. You know, it's crossed INR 800 plus crores now.
Okay. Okay. Thank you. That's.
Thank you. The next question is from Harith Ahamed.
Hi, thanks for the opportunity again. Just following up on the previous question on the working capital increase this year. When I look at the operating cash flows for FY 2026, there's a sharp decline and it's around INR 2,000 odd crores. It's a lower number compared to, you know, our EBITDA for the year, being around INR 7,000 crores. Are there any one-offs? I understand there's a, you know, mirabegron settlement related payout, but anything else that can explain this relatively lower operating cash flow for the year?
This No, I think obviously one is a settlement and we add CapEx, no? The operating cash flow, I think if you really look at it from that perspective, I think whatever the acquisitions that we have done to that extent, whatever the incremental working capital which has happened, it is also impacting us in terms of operational cash flow. The acquisition related, you know.
Okay
working capital changes will have.
Okay
the impact on the operational cash flow.
Okay, okay. Last one with your permission, you know, on international markets. I mean, through the year, we've seen very strong growth in FY 2026. It's around 40%. I think you had talked about this in the last call as well, but just trying to get some more color on what exactly is driving this 40% growth. We haven't seen such a strong growth historically for this segment. Then if you can also guide us on what to expect for the segment going forward.
I think it's, actually it's been all around growth across regions, so it's not a one-off region. I think we're very happy with how most of the clusters are growing. You know, Europe, which was obviously not doing so well for us a couple of years ago, in the last 2 years has also got a good trajectory. I think our new countries that we have launched have scaled up faster than we expected, and done meaningfully well for us. I think all of that is led by the portfolio that they've been able to launch in these markets. I would say again, good execution, branded focus, key therapy focus and also aided by a very strong pipeline has led to this growth, which we believe will continue in the coming years.
Got it, sir. Thank you.
Thank you. The next question is from Nitin Aggarwal.
Hi, sir, thank you for taking my question. Sir, on the U.S., when you look through the next year guidance, should we expect like a, you know, a pickup more in the second half of the year or this is gonna be a, you know, a well sort of balanced growth with a well laid out numbers through the year?
obviously product specific, we would see some traction later part of the year, but we would still see, you know, we will not see any major changes in this next 2 quarters.
Is there any part of the portfolio right now that you've sort of put 320 odd that you did in this quarter, which is probably subject to some faster erosion than the, you know, than average in general? There is, this is all now a $320 odd million which is gonna just go off, you know, will keep growing as a in a typical generic manner.
We are around that INR 300 plus to INR 310 range. We had, as I said, maybe we'll have mirabegron competition, which we have factored in, we would see some erosion from the current base. That's what we are expecting.
Lastly, you know, if you were to look at the 505(b)(2)s that you've done for this year and some of the other specialty launches, what proportion of the INR 1.3 billion you've done for the year would be on that portfolio?
As I said, it's still very small, the specialty business, it'll probably require at least this year we would see some scale up. From FY 2028, we would see the scale up on the specialty business. We are not calling it out separately because it's not very large right now.
Oh, thank you so much.
Thank you. The next question is from Tarun Arora. I think he dropped out of the call. Shall we close the call, sir?
Yeah. Thank you.
Thank you very much.
Thank you very much. Look forward to interacting with you during the next quarter results. Have a good night.
Ladies and gentlemen, on behalf of Zydus Lifesciences, that concludes today's conference. Thank you for joining us, and you may now disconnect your line and exit the webinar.