On specialty - what is the current contribution of the high entry barrier portfolio (rare disease via Sentynl, 505(b)(2) via Zituvio/Zituvimet)? With the pipeline including Saroglitazar for PBC and Desidustat in China, where do you see this contribution going over the next 3-4 years?
We are building on three legs. Sentynl has three approved drugs, has broken even and is going to make profits going forward; adding more portfolio will scale it - high profitable but not high value driven businesses. On 505(b)(2), we have the sitagliptin franchise, oncology supportive care through in-licensing of Beizray, and LiqMeds portfolio scaling up. This will become a more faster scalable business very soon and very profitable as we launch products including Ranibizumab by end of the year. We would see good momentum from FY27 onwards and FY28 would see a stronger momentum. On Saro, we are still in early commercialization. Our vision is that our non-generic specialty portfolio will be the meaningful growth driver for the organization over the next 3-5 years.
On Saroglitazar - we have guided for a Q4 FY26 filing in PBC indication. Can you give an update on the status? If 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. We will update you once we have acceptance of the NDA. Yeah, we have to await the acceptance of the NDA, which is the more important milestone.
On Semaglutide in India - can you give the rationale for the out-licensing strategy to Lupin and Torrent given we have a differentiated reusable pen device? What was the thought process? And from a realization standpoint per device, how different is our own sales versus sales through partners?
We have launched a novel formulation on SEMA. As Zydus alone, we don't cover each and every doctor and specialty. Also being a highly competitive product with multiple launches, we believe the best strategy was to launch with more players to create more share of voice and impact for the new formulation. That strategy has worked very well - we are now number 2 in terms of share and closely followed by Lupin, and Torrent has gained strong share. Together we control a very meaningful part of the Semaglutide market share. We have demonstrated very reliable supply, very strong product with a highly reliable pen, which has been the challenge in the market. First-to-market was also a big success for us. The co-partnering strategy has helped gain strong market share and share of voice and we hope this momentum will continue.
On R&D expenses which have ramped up quite rapidly - almost 700 crore quarterly run rate, probably one of the highest in the industry. Is it all organically driven? Employee expense within R&D seems to have increased at a more moderate pace. How should we think about the 700 crores? Can you split it into generics, biologics, vaccines, and innovation?
R&D is a very critical part for our future growth and profitability. We have been consistently investing in that. We have a little bit of lumpiness during different quarters. We are seeing around 8% of FY27 as our current expectation on R&D. The breakup for the last year is around 50% on generics and value-added generics and the rest 40% plus was on NCE, biologics, and vaccines. As we move forward, we will probably see a little bit higher uptick on the NCEs and biologics and probably a similar kind of absolute number on the generic side.
Any timeline for launches? Is it expected in this year or next year?
Depending on the cycle of approval, we could see some in this year or probably some in early next year.
On Amplitude - we acquired FBC Medical, a distribution setup that is supposed to reduce cost for Amplitude. Can you give clarity on this? What is the current profitability of Amplitude as per FY26? With this initiative, what is the margin profile for next year?
Amplitude is a profitable business upwards of 20% plus. The acquisition we did, there are agents and distributors that you can acquire. So it's a normal course of business that one does it. In parlance it's an M&A, but it's more about sales and distribution kind of consolidation that we do. As I said, this business over the next few years, we will look to improve our profitability and growth.
On MASH - the Phase 3 clinical trial was completed in October 2025 per clinicaltrials.gov. Can you share the expected timeline for publishing or presenting top-line results? Is the company evaluating any out-licensing or co-development opportunity with a large pharma for Saroglitazar in US MASH market?
Currently we have in India a large Phase 4 trial with a 52-week follow-up for fibrosis continuing with its recruitment. In the next couple of quarters we will close on recruitment. As we get data we will publish it. With respect to US on PBC, the company has decided to launch the product on its own; we are preparing for a commercialization strategy in the US. Post favorable approval in the US, we will look to see how we co-partner or license for Europe and other countries.
On working capital - it has inched up quite a bit from Q1 FY26 through Q4. Do we see working capital coming back to older levels?
On overall receivables 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 look at ways of improving our health, both on receivables and inventory. With acquisitions, you would have additional capital that would have got added. But on overall health parameters, we are probably amongst the top in industry.
On the current geopolitical environment and its impact on the supply chain - what kind of disruption are we witnessing from fuel availability, container availability, API prices or raw material prices? How has that been factored into FY27 outlook along with currency benefit?
It's very difficult to predict the next three months and six months. Every day we are solving for challenges or opportunities. Costs do go up on freight, logistics and other things, which we have to manage through better sourcing, rationalization and cost optimization. We are taking it as it comes. As we see new challenges we try to respond to them. The teams are quite efficient. Wherever we see opportunity to improve margins, we look at that. But it's very difficult to predict what will happen in the next three to six months.
On domestic business - Onco IPM growth is very strong; fiscal 26 volume growth was strong while fiscal 25 was muted. Pricing growth in both years was strong. Can you explain what happened in '26 versus '25? Did you experience the same phenomenon in your Onco division?
IPM doesn't truly capture the full business specific to Oncology - Ipsos is probably a better data source. Growth has been there in the Oncology market with more government schemes getting implemented, executed and used, and we have seen a higher incidence of cancers. For Zydus we have captured strong share on launches - Pertuzumab, Nivolumab, some oral Oncology drugs where we were first-to-market. The strong medical support and patient support programs we are running are seeing very strong traction on the brands. We are now the largest Indian Oncology player in the market.
But do you see other trade generics taking away share over time because the government pushes towards that? How would customer acceptance limit this market share erosion long term?
It is a channel and we have to look at how it progresses. But with our innovation pipeline differentiation and core focus on key brands, we can continue to do better than market from our perspective.
What is the biosimilar business size today in India primarily? And out of the $1.2 billion US revenues, if you add all Specialty, rare disease plus 505(b)(2), how large is that portfolio currently?
The Specialty is still in early stages, so it's not meaningfully very large. We see that scaling up over the next three years. On the Oncology, it's obviously become a very large integral part of our business. It's crossed 800 plus crores now.
If you look at the 505(b)(2)s and Specialty launches done this year, what proportion of the $1.3 billion you've done for the year would be on that portfolio?
As I said, the Specialty business is still very small. This year we would see some scale up; from FY28 we would see the scale up on the Specialty business. We're not calling it out separately because it's not very large right now.
FY26 has been exceptionally strong. Where do you see FY27 from a growth and profitability perspective? Any outlook would be helpful.
On consolidated revenue, we still continue to see high teens growth for FY27. We do expect that in spite of a high base of FY26 for North America, we will still see single digit growth in the North American business aided by the portfolio. In India, we will outperform the market by 200-400 basis points versus the current IPM. On international markets, we have seen very significant 40% plus growth for the year and 45% for the quarter and we see that momentum continuing also in the current year. On the consumer side, we see a good momentum on double digit growth. On the margins front, we ended this quarter at around close to 26%. FY27, looking at competition, also Revlimid competition, Mirabegron competition, expenses related to Saro launch, we are expecting margins in excess of 24%. It still assumes 8% of R&D expense.
On Assertio - how does that fit into the three growth drivers? Rolvedon is primarily for Onco supportive care, competing with Pegfilgrastim. How is it positioned versus Pegfilgrastim which has a device for home administration? How are you positioning this molecule clinically?
We already have a supportive oncology team which markets Beizray. We have also partnered with RK for one more future supportive 505(b)(2). So we have a commercial platform to launch Rolvedon. Today it has around 4% volume share. It has many benefits - it's still a novel, long-acting GCSF and not a biosimilar, and it can be administered the same day versus other biosimilars or biologics. We are very confident on integrating it with the business and scaling it up. We also have Ranibizumab launch coming and the current team and resources can be used for that scale up too.
So the commercial presence would be leveraged across many fronts - Assertio and others? And does the 24%+ EBITDA margin guidance bake in that incremental commercial presence for Saro or Assertio?
Yes. Assertio we are not building yet but Saro is part of our plan. But Assertio will not have a cost. I mean, we will see more synergies versus cost.
On India business - you mentioned 200-400 basis points higher growth versus the market. What gives you confidence on maintaining this outperformance? Where would you see more growth coming from? Do you need to make more investment via MR expansion or product acquisitions, or should this drive margin expansion?
Currently we don't see any further rep investment in the short term. We are confident on growth driven by the innovative portfolio scaling up meaningfully, focus on growth booster brands, strong traction on key therapies with launches and monetization of biosimilars, and we are improving our chronic share consistently. It's an all-round performance with many things, innovation led but also focus on brand building on our core brands is helping us succeed.
What investment would Saro be in FY27 for commercial build out? And given investments across CDMO, MedTech, Specialty business with Assertio, could you provide milestones to watch for confidence on when these businesses become meaningful?
On Saro, for this year we'll have an additional 70 million kind of investment on the commercialization part on Saro. That is what we have factored in. With respect to Assertio, we still have to close on the deal but we see it being an accretive deal to the organization. Post closure we can talk about more. The Medical Devices business is a platform build that we are going through. It will take at least 3-4 years before we see a strong momentum but we would see improvement of cost and profitability as we build synergies. On Comfort Click, it is already a strong growth business and EPS Accretive in Q4 and going forward. On the Agenus / Zylidac manufacturing acquisition, we would need the next 2 years to build capabilities; BOT-BAL supply continues and we will see better utilization over the next 3 years but at least 3 years before the facility is well utilized.
And this BOT-BAL contribution isn't very meaningful at the moment, right? It's just incremental but not a big revenue contributor?
Yeah, so it's not going to be significant but it's around 10 to 15 million revenue.
Lastly, on Rolvedon - did you mention that the dosing schedule for this product is different versus Pegfilgrastim or is it the same?
The main thing is it can be administered on the same day, which is one of the benefits versus the next day for Pegfilgrastim.
On SEMA - based on your initial experience in India, how large can it be for Zydus over the next 2-3 years? Is there something you would like to do with this device in other emerging markets, or is this largely India specific?
We combine have one of the strongest market shares in this new device. There has been good acceptance. We are seeing a better forecast than earlier for all our partners and both Zydus, with higher uptick and more confidence going forward. We have a plan to make sure this new formulation is available across different markets. We already have a partnership/registration plan for more than 20 plus markets which is ongoing. We are not in the first wave in many of these, but with this differentiation offering significant cost benefit to government and patients, we would see good momentum. We are filing and partnering in many markets as we speak.
Can you guide for FY27 capex number? And the depreciation number is high in the quarter - is this the number we should bake in on an annual basis?
We have had an uptick on our capital investment because of multiple initiatives that were taken on expansion. We are thinking in FY27 around 1,500 crore capex number. And the quarterly depreciation is around 550 crores. (Mr. Tushar Shroff added: This also includes the licensing fees that we have capitalized on the settlement of Mirabegron, which will be charged up to September 2027. So it is a limited period charge-off; thereafter there won't be any kind of cost associated with this depreciation.)
What really led to the sequential growth in the US business, despite Revlimid not being there? What is the like-to-like growth in the US business for FY26? And on the $75 million that is still likely to be seen as amortization, beyond that is there no royalty charge in case of Mirabegron?
There is a royalty charge. As stated in the last quarter, we had very little Revlimid contribution. There are 2-3 factors. One, December end has destocking and you see higher uptick during Jan-Feb-March quarter, so there is a small incremental benefit. Multiple levers of new products launches, the Specialty portfolio scaling up. Our base business continues to be healthy and consolidated share grew, including some more share on Mirabegron. Overall, we are around the 300 plus million base right now.
So this 300 million base is sustainable going ahead, since you are talking about single-digit growth for next year despite no Revlimid revenue?
Yes.
On the comprehensive approach to biologics / biosimilars / CDMO - when is this vertical likely to be a meaningful contributor to Zydus?
The biologics part of our business is very scaled and meaningful contributor to our India business. It continues to do extremely well. With our partnerships and filings in EM markets, we would see over the next three years meaningful scale up of out-licensing and launch of biosimilars in many of these markets. In the US we have thought it through well; we have been waiting for the regulatory framework to change to make it more beneficial for R&D development. We would see important milestones for biologics in the next three years, but more importantly by FY29-FY30, we would see the real scale up on the global biosimilars business.
For FY27, what are your capital allocation priorities? Will the inorganic momentum continue given FY26 was a heavy inorganic activity year?
We have been talking about building new capabilities when we look at our capital allocation strategy with new platform capabilities or new portfolio. Many of the inorganic opportunities we looked at have helped build capabilities and platform. Going forward, scaling up our Specialty business including 505(b)(2) would be one of the important areas we would continue to add portfolio to. Beyond that, we have a good R&D pipeline of products to come through which we are betting on. Mostly it will be bolt-on acquisitions that we could look at from the Specialty point of view. Also our international business is doing extremely well, growing at 40% plus, and we are seeing opportunities to create a strong leg of growth there.
On Saroglitazar PBC - given the trial data is in hand, is the company planning to present or publish PBC clinical trial data at EASL 2026?
Yes.
When can we expect Desidustat launch in China? What is the company's revenue expectation from this product in the Chinese market?
We will hope to see launch in second quarter of FY27 in China. As we get more information on the commercial launch and readiness with the partner, we can talk about it.
Lastly, any progress on specialty acquisition for synergizing Saro launch?
No.
On the debt side - we are at around 4,500 crore debt, and with buyback and Assertio acquisition we would be close to 7,000 crore net debt, not considering cash generation in FY27. Do we de-leverage from here or comfortable at this debt level which would be slightly less than one-time net debt to EBITDA?
We are comfortable around one-times net debt to EBITDA right now on an ongoing basis, so we don't see that as major concern. We continue to look for bolt-on acquisition opportunities for our specialty 505(b)(2) franchise. We are currently comfortable with our current financial metrics.
And this bolt-on would be on the same strategy of orphan, rare disease, right?
Yes.
At this point, would you say rupee depreciation is enough to cover all the disruption in terms of increased cost line items?
Yeah, we have a good export base. So obviously rupee depreciation gives us a good cash flow.
How do you see the trade generic proposition as a long-term opportunity or threat? 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.
Is the pricing growth also strong in Onco line of business or other chronic line of business compared to overall Indian formulation business?
Pricing generally deflates. Prices go down, not up. It's a faster volume growth than value led growth.
On working capital - operating cash flows for FY26 show a sharp decline at around 2,000 crores, lower than EBITDA at around 7,000 crores. Are there one-offs? I understand Mirabegron settlement is paid later, but anything else that explains the lower operating cash flow?
(Dr. Sharvil Patel: So this... one is a settlement and we had a capex.) Mr. Tushar Shroff: The operating cash flow, if you really look at it from that perspective, whatever the acquisitions that we have done, whatever the incremental working capital which has happened, it is also impacting us in terms of operational cash flow. So the acquisition related working capital changes will have an impact on the operational cash flow.
On international markets - very strong growth in FY26 of around 40%. What exactly is driving this 40% growth? We hadn't seen such strong growth historically. What should we expect for the segment going forward?
It has actually been an all-round growth across regions. It's not a one-off region. Europe, which was not doing so well a couple of years ago, has got a good trajectory in the last two years. New countries we launched in have scaled up faster than expected. All of that is led by the portfolio that they've been able to launch. Good execution, branded focus, key therapy focus and a very strong pipeline has led to this growth which we believe will continue in the coming years.
On the US, in the next year guidance, should we expect a pickup more in the second half of the year, or balanced growth through the year?
Product specific, we would see some traction in the later part of the year, but we will not see any major changes in the next two quarters.
Is there any part of the portfolio in the $320 million quarter US revenue which is subject to faster erosion than average? Or this entire $320 million base is going to keep growing in a typical generic manner?
We are around the 300 plus to 310 range. We will have Mira competition which we have factored in. So we will see some erosion from the current base. That's what we are expecting.