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Ladies and gentlemen, good day, and welcome to Cipla Limited's Q3 FY '25 Earnings Call. [Operator Instructions] Please note that this conference is being recorded. I now hand the conference over to Ms. Diksha Maheshwari, Lead Investor Relations, Cipla Limited. Thank you, and over to you, ma'am.

Thank you, Mishal. Good afternoon, and a very warm welcome to Cipla's Q3 FY '25 Earnings Call. I'm Diksha Maheshwari from the Investor Relations team at Cipla. Let me draw your attention to the fact that on this call, our discussion will include certain forward-looking statements, which are predictions, projections or other estimates about future events. These estimates reflect management's current expectations of the future performance of the company. Please note that these estimates involve several risks and uncertainties that could cause our actual results to differ materially from what is expressed or implied. Cipla does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new confirmation, future events or otherwise.

I hope you have received the investor presentation that we have posted on our website. I would like to request Umang to take over.

Thank you, Diksha. Good afternoon to all of you, and we appreciate you joining our quarter 3 earnings call. I'm pleased to share that 2025 marks our 90th year in the journey of caring for life. It's an exciting time for us to move forward on our innovation-led and care-driven commitment to provide the best health care solutions across the globe.

We are fully committed to do our best in providing health care with a focus on equitable access, so that no one should be denied of medication. Cipla looks forward to another decade of science, innovation and technology. Over the past 3 years, we have been derisking our manufacturing network and products to our U.S. facilities. Between fiscal year '20 to year-to-date fiscal year '25, we have spent almost $100 million of CapEx in these facilities. With this enhancement, we now have DPI, MDI and existing large volume OSD facilities in the U.S.

Filings from these facilities have already commenced, including the filing of generic Advair, a major inhalation asset. The backlog of our key assets of generic Advair -- sorry, of generic Advair, generic Abraxane and 1 partnered inhalation asset have the potential to help us grow the U.S. top line post generic Revlimid. We also have created a well-diversified business portfolio. As you're aware, our EMEU and One Africa businesses put together accounts for more than 25% of the company's total revenue, similar in size to our U.S. business.

In 9 months, of fiscal year '25, both of these markets combined have delivered a strong growth of 15% year-on-year in INR terms. Our diversification and backlog of our launch pipeline gives us confidence of a resilient business model. In FY '26, we'll retain our guidance to grow our top line. We will further provide guidance on profitability once we finalize the budget.

Coming to the quarter performance. Despite seasonal headwinds, especially in the acute category, our One India business delivered a healthy growth of 10% year-on-year. In our branded prescriptions business, we continue to outpace market growth in our key therapies of respiratory, urology and acute with the overall chronic mix improved to 61.5% year-on-year as per MAT IQVIA in December '25. Our big brand franchisees continue to achieve key milestones during the quarter.

FORACORT continued to be the #1 brand in IPM. We have now 5 brands with revenue over INR 100 crores in the IPM to reach a total -- sorry, we added 5 brands with a revenue of over INR 100 crores in the IPM to reach a total of 26 brands with revenue greater than INR 100 crores. We now have 7 therapies with a top 5 rank in the IPM.

We continue to be the largest pharma company in terms of volume and the only player with 2 billion plus unit sales in IPM as per the IQVIA MAT December '24. During this quarter, we launched CipAir, an AI-powered mobile application to simplify asthma screening in India. In our Trade Generics business, we are back on the growth trajectory.

The performance was supported by execution excellence in our -- in distribution, new introductions and technological interventions. Our Consumer Health business witnessed strong traction with anchor brands continuing to grow bigger. Our anchor brands, Nicotex, Omnigel and Cipladine maintained leadership position and ranked #1 in their market in their respective segments.

We continue to build on this by driving healthy secondary growth and thrive to look for opportunities to invest in products and channels to strengthen our distribution network. The operating profitability of our Consumer Health business remains consistent. In North America, we delivered a quarterly revenue rate of $226 million. If adjusted for the supplier disruption in Lanreotide, our revenue would have been on a growth trajectory.

Albuterol market share further enhanced to 21% as per IQVIA MAT week ended 27th December 2024. The business is on its way to resolve supply issues related to Lanreotide and come back to normalized supply levels towards the end of quarter 4. We've also received various generic drug approvals, including Phytonadione injectable, Esomeprazole granules and potassium phosphates injection. Our One Africa business recorded a significant growth of 9% in U.S. dollar terms with South Africa growing at a rock-solid 21% in ZAR terms.

In our private market, our secondary growth was at a healthy 8.8% versus the market growth of 2%. Our South Africa private market now ranks #2 in the market with the prescription business maintaining its #1 position as per MAT November '24. North Africa also demonstrated a strong growth during this quarter.

In EMEU, our deep market-focused strategy laid a strong foundation with the business delivering a strong growth of 20% year-on-year in U.S. dollar terms with the uptick in both our DTM and B2B categories. We've also sustained our operating margins. We continue to invest in our pipeline for these markets with focus on execution excellence.

I'll now provide an update on our regulatory front. As highlighted in the beginning, our Goa facility has been cleared by the U.S. FDA with a VAI classification. During this quarter, the U.S. FDA also inspected our manufacturing facility located in Virgonagar, Bengaluru and issued 8,483 observations. Official classification is awaited.

During this month, we were also inspected at our Medispray facility by the U.S. FDA and issued 1,483 observation. Official classification of this facility is also awaited. I will now request Ashish to present the financial and operational performance for this quarter.

Thank you, Umang. I'd like to present the key financial highlights for the quarter. This quarter has been yet another quarter of highest ever quarterly revenue, and all-time high EBITDA margins. That's excluding the other income, as we always do. All numbers, as I talked about, are adjusted for QCIL divestment, which is sitting in the previous year. So we reported quarterly revenue of INR 7,073 crores with a growth of 8% Y-o-Y, driven by our core businesses of India, North America, South Africa and EMEU.

Each of our markets, other than U.S., which we already talked about, grew at double-digit Y-o-Y. One India grew at 10%, One Africa grew at 10%; again, and EMEU grew at 22% in INR terms. The EBITDA margin stood at impressive 28% for the quarter, up by 184 basis points Y-o-Y and 138 basis points Q-o-Q.

Reported gross margin after material costs stood at 68% for the quarter, which is 166 basis points above the last year's figures, driven broadly by overall mix change. The total expenses for the quarter include employee costs and other expenses, which stood at INR 2,820 crores, in line with the revenue growth. Employee cost includes our strategic investments in India-branded prescription business field force, especially on the chronic therapies. From FY '23 to 9-months FY '25, we've added 1,800-plus feet on ground.

As highlighted earlier, we have also introduced to retail taskforce in India in Trade Generics business. A team of 500-plus feet on ground has been added for better visibility in the business. In addition to that, as we completed our Trade Generics model change, the employees of our marketing agents were onboarded, adding the cost to the employee cost, which will be set off against the reduction in the commission going forward.

The R&D investment for the quarter is at INR 360 crores or about 5% of the revenue. It is primarily driven by product filing costs and developmental efforts. The R&D cost is likely to moderate as the requirement of clinical trials are relaxed, but we retain our guidance of 5% to 6% as it actually gives us an opportunity to add more product programs to our pipeline. The profit after tax for the quarter is at INR 1,571 crores or about 22% of sales and adjusted for one-offs, the effective tax rate is at 25.5%.

Our free cash flow generation and operating efficiencies continues to drive a healthy net cash position. As of 31st December 2024, the debt on our balance sheet, including lease liability stood at INR 466 crores with net cash equivalent balance of about INR 8,947 crores. Our unwavering efforts continued on derisking our assets for generic Advair, the derisking has been progressing as per expectation, and we plan to launch this asset in late half 1 of FY '26. And for Abraxane, we expect to launch it from our Goa facility post few months after the approval and the launch should largely be by -- towards the back end of half 2 FY '26.

Now, I will conclude with the key focus area and growth levers in the subsequent quarters. The priority for One India would be to continue the growth momentum to be ahead of the market in both Branded Prescription and Trade Generics. We will further work on solidification of our growth levers for wellness portfolio, including ramping up in our new launches.

In North America, our focus would be to resolve supply issues, maximize the commercial execution and expedite the launches from our U.S. facility. In South Africa, our focus stays at margin expansion. EMEU, our top priority is to maximize top line with focus on deepening our penetration in identified core markets while sustaining the strong margin trajectory. EBITDA for the year FY '25 is trending higher than our earlier guidance that we've given, which was 24.5% to 25.5%. Our ROIC continues to be strong at 30%.

Thanks for your attention. I'd like to just hand it back to the moderator for Q&A.

[Operator Instructions] The first question is from the line of Saion Mukherjee from Nomura Securities.

My first question is around the U.S. revenue trajectory. So we understand the slowdown this quarter. But if you can give us some details with regard to Advair, Lanreotide and Revlimid, how that trended sequentially? And also, it seems like there is some delay in your key product launches in the U.S. How should we think about the next few quarters in terms of the U.S. revenue trajectory?

Revlimid is sequentially more or less the same. There is no increase in -- I think there's no increase in Revlimid quarter-on-quarter sequentially. On the rest of the assets, Advair, we've still not launched, and we are signaling a Half 2 launch from the U.S. facility. On Abraxane, we are saying we have a definite launch at least by the end of this next year and a few months after approval.

I think the delays are largely due to regulatory clearance and filing and things and post that, it should follow. So we believe that if we were to add a full year basis of Abraxane and a full year basis of Advair and a full year basis of the partnered inhalation asset, we believe that this is quite meaningful in the ability to offset share of the generic Revlimid reduction. It may not offset the total amount, but it will offset a significant portion of it.

Understood. Okay. And also on the contribution from Global Access and PEPFAR in particular, if you can share because there is some news on funding constrain there. Any views if you have? And how will that impact Cipla?

We have only less than $1 million worth of PEPFAR supply products from Cipla. And whatever -- this $1 million comes at basically no margin. So there's no impact to Cipla basically on this.

We'll take the next question from the line of Kunal Dhamesha from Macquarie.

The first one, can you provide your view on the recent comments from the U.S. President on tariff on the pharmaceutical product? And what is your base case scenario here? And what could be your strategy in the worst-case scenario?

Yes, I think I -- we can't comment specifically because the -- I think we have to let the policy framework of the new administration set in. And whatever we're hearing right now is through the press and through media. So we just like to see what's coming out as documented plan of action from the government. So we can't comment on that. But just the other thing that maybe I would like to add is that the last 3 years, we've now been setting up facilities in the U.S. So there will come a time when we begin to understand the economics of shipping straight from India and having potential duties or whatever or -- and the freight with it linking up with what the cost of manufacturing and supplying for the U.S. is.

So in some ways, our model is derisked to a large extent for our portfolio, whether it's the MDI or the DPI portfolio and the OSD portfolio. So I think we're just waiting for more -- we are waiting for more color from documented activity. But I think we're well derisked to be able to offset some of this as and when it comes on.

And in addition to that, if you look at the supply, which U.S. gets, okay, it's about 1/3 of supply from India. Otherwise, we have partnered products, CMOs, and we have, of course, Invagen, our local facility out there also, which meets the balance.

And secondly is on the FY '26 outlook, which you provided on a broad base that you expect to see the revenue growth in FY '26. Could you provide more color on probably the segment-wise growth expectation, primarily, like U.S. I know you have indicated that Advair and Abraxane is -- seems to be like more H2 FY '26 product. So beyond these couple of names, do we have other products, which could help us grow? And second part to that question is how is the price erosion in the U.S. market evolving in the quarter 3 and in January.

I don't think we've seen anything abnormal on the price trajectory within the U.S. so far. Depending on the channel you're in, whether you're in retail, institution or the government business, the pricing action differs on that. But there's nothing unusual we've seen. Maybe on your other question of whether we have a pipeline asset beyond these 3 or 4 assets that we mentioned, yes, for certainty, we have a pipeline asset and notable in that is 2- or 3-star respiratory assets that hopefully can come in 18 to 24 months and have been filed. And we also have other peptide assets, et cetera, within that mix.

[Operator Instructions] We'll take the next question from the line of Damayanti Kerai from HSBC.

My first question is on albuterol. So in last 2 quarters, you have gained significant market share. Now like you are at 21% market share as per your presentation. So do you see further headroom to gain market share? And also if you can comment on the pricing environment in the albuterol market?

The pricing other than marginal erosion it's stable. And in terms of our market share, I think we are slightly more recently ahead of 21%, but that's where we see it stabilizing.

So like with this pricing -- broadly stable pricing and if you gain further market share, do you think you can gain, like, it will remain a substantial contributor for the U.S. business that we can assume, right?

Yes. Yes, you can, Damayanti. I think the -- the one thing here is that we were at something like 16%, 17% share and then the share began to moderate a bit just after the inspection we've had in Indore and then we built back from there to the share that we have right now. But from here, I think share increases will be very moderate.

It's also supply dependent.

Yes. And we've got a -- it's a fair number of inhalers that are going out. So I think it will be more moderate from here.

My second question is on Lanreotide. So you mentioned the supply issues are abating and then maybe towards the end of March quarter, you'll start -- you'll be back to normalcy. But I just want to understand how should we assume the trajectory ahead, whether it will -- like it will happen in stages? Or are you expecting, say, a quarter down, you will be back to the level where you have dropped?

The endeavor is to come back to the level that we had earlier. The question is the timing to get there. I think we -- based on the manufacturing set up there, there are 2 lines that manufacture. We have been working with our partner very closely. We've put in a lot of effort into rectifying the supply situation. And we believe that from a supply perspective, we are probably about 50%, 60% there. And what is not there is being rapidly -- the partner is rapidly working to bring that online as well. So our expectation right now is that the full capacity of the partner probably comes in -- starts getting delivered pretty much from the end of March. And so that allows us the ability to potentially see the ramp-up in quarter 1 as also gives us the ability to build a little bit of inventory.

Sure. And just a clarification. This supply is for 505 (b)(2) or it will be for the generic formulation as well? .

For both. Both products pretty much share a supply chain.

The next question is from the line of Neha Manpuria from Bank of America.

Just a clarification. Did I hear correctly that Abraxane launch is at the back end of second half fiscal '26?

Ashish?

Yes, it will be your second half FY '26. That's more like the outcome.

And the reason for delay given that Goa is cleared, is there anything in the application, the ANDA that is required and you also mentioned there'd be a little bit of lag post approval to launch the product. So just trying to understand the reason for the delay in the launch?

Yes. I think, Neha, the -- we are -- there are 2 things that have to happen. One, we have to first get approval for the file. So while Goa has cleared and the earlier information to us was that there is nothing pending in the file from an FDA perspective, we still have to get approval for it. And I think, obviously, we are waiting for that approval.

Once that approval comes, we will have the ability -- we will need to take a few batches, et cetera, because we've not really manufactured the product and the site was under remediation. And so I think that may take us to get ready for launch, it may take us some amount of time. So depending on the approval, we'll have to add some time to it. So it could be 9 months from now, it could be 6 months from now. The approval comes tomorrow, it could be 6 months from now. The approval comes a little later, it could be 9 months from now. But we definitely expect to launch the product by quarter 4 of FY '26.

Okay. Got it. So the only delay -- I mean, there's nothing pending from an application perspective from the U.S. FDA on Abraxane?

Yes. And I think the first validation of that will be the approval hopefully, whenever we get it.

And is there a PA required, in your view for the approval? Could that be a roadblock?

Neha, we are not clear about that. So which is why we are waiting to hear from the agency. And our belief is that if it is required, it will follow very shortly now since the site has already got the AI state.

Okay. Got it. And I think, Umang, last year, we've had also mentioned a couple of 505(b)(2) assets and a few peptide assets that we expect to launch this year. Other than the Lanreotide generic launch, we haven't really seen any other large launches coming through. Can you give us an update on when do we see the 505(b)(2) assets and the rest of the peptide assets coming through for us?

So I think, yes, we are looking at -- close to -- so we've launched about 2 this year, right? We have 1 which we still need to launch, and we are hoping to launch it, perhaps, the remainder of this year. And then we have 2 planned in terms of peptides in FY '26. And then we've got the rest of the assets. But the peptide ones looking at one -- or let me put it this way, looking at approximately 3 over the next 15 months.

Okay. Okay. Got it. And one last one, if I may. On the Trade Generic business, now that it's getting back to normal growth trajectory, are we seeing a slowdown in growth even in Trade Generic. Previously, there were numbers floating around that the Trade Generic market is growing in the 15% to 20%. Has that growth for supply in your view now on a steady-state basis, more like high single-digit, low double digits? How should we think about the Trade Generic business growth from here?

I think that generic -- the Trade Generic business, at least what we've seen over -- so there are some factors, Neha, which are typical to us, which was the transition that we were going through in the first quarter or second quarter. I think in the third quarter, the Trade Generics and the branded are more or less matching. I think the trade is slightly faster than the branded. So that trend is continuing. But relative to the previous year where there was, perhaps, some higher pricing impact in the market than this year, that element of growth has slowed.

So for example, if the overall price increase that was allowed in the market last year was 3% or 4% versus that if this year, the general average is 1%, that 2% or 3% is offset from the overall growth in the market. We did see a slower volume offtake due to season largely in the first 2 quarters of the year, but that may have also been because of our transition, but it may have also been because there was a very, very slow season in this year, too.

We'll take the next question from the line of Ankush Mahajan from Axis Securities.

Congrats for the good set of numbers. So very strong gross margins this time that has led to the expansion in EBITDA also margin. So sir, what are the reasons behind it? And how do we see gross margins stand in upcoming quarters?

Ashish Bhai.

Yes. So I think it's a combination of the mix that we have in the business. This is always the best quarter for the -- for us because of the respiratory uptick. So that actually helped us. There is also some cost control that we've seen some phasing impact of the cost as well. That has helped us to achieve this margin. And like I said, quarter 4 is seasonally low. So overall, for the year, if you look at it, we should land at higher than the guidance that we've given of 25.5%.

Sir, what is the -- what is the sustainable trend now?

Sustainable margin, you meant?

Yes. So are we increasing our EBITDA margin guidance for our company?

So like we said in the beginning of the call, for next year, once we finalize our budget, we should be able to give you the guidance.

Sir, last 1 is how is the price erosion in the base portfolio?

So we've had -- I think price erosion is dependent on the basket. So while some of our products may have faced some erosion and the others have not, on an overall basis, it's a moderate erosion that we had of high single digit. While -- like I said, in certain segments, we saw higher erosion.

The next question is from the line of Anubhav Agarwal from UBS.

First question is on Lanreotide. Just trying to understand, let's say, we index our production for supply to 100 before the problem started, once you come back in, let's say, April, would you be back to 100? That's part A. Part B is, I think all the problems with the partner was driven by capacity expansion for Lanreotide. So what point of time would you -- let's say, 100 will become 120 or 150 for you guys?

Yes. Anubhav, I think right now, we are at roughly close to 40% to 50% of their overall index of 100, right? And we expect that by the end of March, we would be back to the 100, right? Now capacity expansion at the partner is a function of 2 things. It's a function of the capacity train, which is now in place. It's also a function of batch size, which is the ongoing work that we are -- that will also happen post April. So I think that the capacity will go up in stages. But right now, the train, et cetera, is all in place for -- to allow that capacity increase. So we are going to be back at the index level, and the batches will start for capacity expansion post April.

So let's say, in second half next year or let's say in FY '27, could you be like 50% higher than this 100, closer to 150, just as an idea?

I'm not sure, we'll be 50% higher. This is a pretty tough product. But yes, it could be 20%, 25% higher. And at the same time, we are also examining other options beyond this -- just this partner for overall capacity, which means the partner and us are examining expansion of capacity at alternate sites as well.

Okay. That's very helpful. Second, on the respiratory portfolio today, in the U.S. ballpark, we are about $150 million, $200 million out of -- I'm talking annual number. let's say, once we launched Advair, Symbicort, your partner in relation has said, Q1, also like FY '28, for example, what kind of ramp up could we see this $200 million can $400 million, let's say, double from here? Can you just roughly talk about the scale-up?

Yes. Look, today, we are slightly more than that number because we've got albuterol, we've got budesonide, both falling in that category of respiratory. And without getting into numbers, if you look at the pipeline itself, some of our larger assets that are coming out of pipeline are actually respiratory. So we've talked about Advair, generic Advair, we've talked about generic Symbicort, QVAR, one of the partnered inhalation product, and there are -- there is just 1 another large asset that we are looking at. So all put together, gives this large portfolio of respiratory. So the share of respiratory overall is likely to go up with all these coming, which will all come over a period of time.

Sure. No, I was just trying my luck that can this portfolio double? Is that a possibility there? Or -- because all assets are large, is there a potential to double the respiratory contribution?

No, I think, Anubhav, the way to look at it is depending on the type of the asset. If -- for example, we have albuterol, which is a large asset. But if you were to look at the type of asset, keep in mind that we are likely to have 3 more over the next, maybe 15 to 18 months, launching in the U.S. And they're all kind of sizable categories of assets. So depending on the timing, it could be. And the problem with this is that it's very binary to each asset. So if nobody else comes in, in the assets that we are in right, then it's a much larger delta compared to if other show up before us.

But if your question is whether this will double, triple, it's going to be moving up step functions. It's going to be moving marginal increases with each asset being approved.

That's helpful. Just 1 clarity on the India business, on the consumer wellness side. Last year, quarter-wise, we were doing about INR 250 crores, now the run rate has increased to INR 380 crores. Just trying to understand that. So we made 1 acquisition in quarter 4. So is there a more shift which has happened from Trade Generic to Consumer Wellness that is like INR 70 crore, INR 80 crore per quarter, which has shifted there? What is leading to such a high growth in consumer wellness in India?

So last year, quarter 3, quarter 4. So if you remember in last year, in quarter 1, we had transitioned 2 big assets to consumer health. And when we transferred 2 big assets to consumer health, we had -- anytime you transfer assets from one division to another, you do tend to take time to regain distribution. And that was the problem that was reflecting us in quarter 3 and quarter 4 of last year. So the base went down a bit. It was a base impact.

And then in this quarter, not only is the base impact of last year there, but also we've grown quite significantly faster on some of these categories because of the branding effort, et cetera, that we've put in. So yes, and then there was this acquisition that we had as well. So we had an acquisition. We have 1 or 2 BD deals that we have done, and we have our natural growth that is coming. But our endeavor is to continue to grow the wellness franchise because I think it's -- I think Cipla has a good formidable position for it now.

Yes, indeed, it's very -- it already become INR 1,600 crores, INR 1,500 crores.

We'll take the next question from the line of Bino Pathiparampil from Elara Capital.

Umang, could you explain how the Abraxane market is now because already, there are 3, 4 players and you will be another year or more to launch. What's the sort of price erosion, market share gain by generic, et cetera, as of now in the market?

I think the understanding we have of the market that there is possibly 2 505, one fully entrenched 505(b)(2). One Teva product, which effectively is an AG and one Sando generic. That's our understanding today of the market. We believe this market is likely to move more towards generic alternatives, right, and not necessarily 505(b)(2). Till the time the generics -- till the time the generic player launched, the market well could have been just a 505(b)(2) market. But post the generic launch, we do think that a large section of the market begins to convert to generic. I do think that this market will still be attractive because nanopaclitaxel is now a fairly significant capacity to ramp up. It is not an easy product to ramp up. And I do think that there will be opportunity to -- for generic players in the market as well.

Got it. But when you enter, what do you think the price erosion could be or the pricing could be compared to the original innovator levels before generic entry? Even if you give a rough, could it be just 30% lower or more like 50%, 60% lower? Or could it be 80% lower?

Well, the issue with the price conversion is that it also depends on how the families -- how the families of assets, whether the B2s or the generics are tagged from a perspective of insurance in the market, right? I don't -- I kind of think that we will not see more than 1 or 2 players enter this market. So I'm not sure this is going to be hypercompetitive, but then we have to wait as the market begins to pan out. We are aware of what the rough ratio in the market is today. But we'll be able to provide more color to it. But right now, we think that it's fairly attractive for us still.

Got it. And South Africa market has been exceptionally strong growth this year, all 3 quarters. So is there something really happening because it's higher than usual trend growth there?

No. So the growth has been basically coming from 2 areas. One is that we've had new launches out there. So that's basically taking away share from others as we launch new products out. And the second has been we've been selective about tender. We want to maintain the margin that we have in the overall business. So therefore, the tender businesses have gone up. But our focus has been to make sure that we do the tender business at the right margin. So that has also led to the growth in the South African market.

Understood. One last bookkeeping question. What would be the consolidated tax rate for full year. This quarter was especially low.

27%. We're guiding to 27%, 28% ETR for the full year.

The next question is from the line of Chirag from DSP Asset Managers.

So 2 questions. First is on the U.S. FDA issues. We kept on seeing these crop up every once in a while. And this is quite unlike what Cipla historically has been. So Umang, what is it that you're trying to make sure that these issues we fix these longer term. We recently got approval for one of the larger facilities, but the other one still continues to remain under issue. So how are you thinking about the reasons why these -- we've frequently gotten into these issues? And what are we doing longer term to make sure that these don't repeat.

And the second one I had was on capital allocation. We have INR 9,000-odd crores almost of cash. How are you thinking about capital allocation going forward?

Yes. Ashish, you want to answer on the capital allocation?

Yes, sure. Chirag, let me probably address the capital allocation it. So you've seen that in the last 2 years, gradually, we've increased our dividend in line with the profit increase. And we have given guidance of about 30% to the market as well, and we're sticking to that. I think we see a lot of growth opportunities yet in many areas in India, which is our core market, and now we see some gaps in our portfolio, which we want to address through acquisition in many forms, not just whole company acquisition, but product acquisition, in-licensing, et cetera, et cetera. And then in the U.S., any differentiated assets, we are looking at acquisitions there. Overall, in rest of the world as well, any attractive market we're looking at opportunities there.

So I think -- and then we want to land some allocation for innovation as well, very recently, we've looked at certain assets on the innovation category, and we continue to scout for those. So that's the dry powder that we've kept that we are constantly looking at those. And I think a lot of our growth will come from these acquisitions as well in the future.

Yes. So Chirag, on the first -- do you have Chirag, is anything else as a follow-up to Ashish, otherwise I'll take the first.

No.

Just on the quality piece, Chirag, actually, the last we have 2 -- we had 2 inspections where we receive citations and adverse rating. One was Indore and one was Goa. Indore happened in 2023, February. So where we are right now is that Indore facilities have to be reinspected by the FDA and there were some observations in Indore, which were kind of similar to Goa in terms of sterile practices, et cetera, which we are hoping that will probably be addressed by the time the FDA comes to inspect again.

And it then depends on how that inspection is assessed by the FDA. So I think there's been a lot of progress made. And certainly, we've had many other inspections from the U.S. FDA at several of our other facilities. And while we've received observations, we have been able to remediate and secure a compliance certificate from the FDA that allows the new product launches and operations to continue. Structurally, how we are solving this is it's -- quality is a function of practice, equipment and talent. And we have worked on all 3 of them. The more you can automate your equipment, the less there is a chance of -- there's a chance of any errors that happen. The more that you can build in sensitivity to your talent about how to do proper root cause investigations and observe your processes, the less you will have disruptions. And the more that you can -- the more that your practice is converge with what your guidelines are, the more you will be able to conform. So we have worked on all 3 aspects, and we will continue to work on this.

The next question is from the line of Abdulkader Puranwala from ICICI Securities.

Sir, just firstly, on generic Revlimid, I heard your commentary previously about the flattish revenues for the quarter on a sequential basis. But if we have to look at the 9-monthly number, then if you could throw some light as to where are we on the overall target for shipment of this particular product, would we kind of see some sales moving up in Q4 as well from this product or a large part of it's already booked in the 9 months?

No. So see, I think like Umang mentioned that quarter 3 was a similar number to quarter 2, and that's what we expect going forward. Specific numbers, we avoid the guidance because we are -- by a contract, we can't share those numbers.

And sir, in the past, you have spoken about filing a couple of oligonucleotides. And in terms of your near-term launches, you're calling about 3, 4 products. So by when should we see the launches of these products happening into the U.S. market?

We're looking at filing some of these products in about 3 to 5 years' time frame. So there is still time for oligonucleotides launches to come through.

The next question is from Umesh Laddha from Nirmal Bang.

So actually, I wanted to know that how much of our One Africa and emerging market sales are constituting of anti-retroviral agents, API and FDF combined.

Sorry, API and...

API and FDF fixed dose formulations combined, how much are we exporting ARVs to emerging markets and South Africa?

We'll have to come back to you with that exact number. Largely, the number is going to be in South Africa and African continent and very little in emerging markets. So we have -- and Africa is about 11%, 12% of our total. We don't sell any anti-retrovirals in North Africa, primarily the sub-Saharan and South Africa. So we can come back to you, but I would not expect that number to be more than 3% to 5% of overall revenues at max. It cannot be higher than that.

And to the rest of the world, we do it through our global access, yes, and come back with specific numbers.

Okay, sir. And sir, what are the margins which we are getting from this portfolio, like if you could just give some color.

No. See, it's competitive. These are all tendered. All I can tell you is that the margins we make here are very low and they are not at -- they are significantly lower than company average.

And we do it for a different reason. We do it to ensure access for these products in the countries that we offer it.

Okay, got it. And sir, lastly, on the India business, are we planning to launch semaglutide? And there is a 10% revenue growth in the India business. So can you just give a split like how much of this has come from price and volume if that's possible.

No, I think the question was around semaglutide.

Yes. sema -- we can give you. Just to clarify, I want to also be very clear that PEPFAR as a portion of Cipla's business is less than 0.2%. So we do less than 1 million of PEPFAR. So while your question was broader on HIV, just wanted to also clarify that in PEPFAR, the business that Cipla has exposure to is less than $1 million.

Sorry, you finish your thought on Semaglutide.

On semaglutide, I think just semaglutide, we believe the market will form in 2026. And there will be, obviously, depending on who all gets approval in India. I think Cipla is aiming to be in the first wave of launches.

I think you had a question on price and volume in India?

Can't estimate the volume. I mean, with obesity as a category, it's very difficult to estimate volume, the overall growth for the company.

So I think last -- this was a weak season overall, like we mentioned. So the volume growth was around 2% and the balance was coming for us from price and NI. So kind of a balanced growth. And so we see some improvement in the volume growth in the coming years.

The next question is from the line of Surya Narayan Patra from PhillipCapital India Private Limited.

Sir, my first question is about the Horizon 2 initiatives that we have taken and based on which we have been anticipating, CDMO opportunity leveraging our peptide as well as injectable capability. So could you give some update on that, if any.

Yes. No, I think we -- in the last call also, we had clarified on the CDMO. So we are not looking at CDMO as a business opportunity for us. What we have said is that in peptides, we partner with the CDMOs on development and manufacturing of the product. But it's not a business for [indiscernible] to be in India.

Sure. So this clarification is useful, sir. Second question is on the injectable side, so how big is the injectable portfolio right now or in terms of, let's say, business mix in the U.S. currently? And could you give some sense about the pipeline in the complex injectable side that we are talking about?

It's likely going to be peptides to start along with nanopaclitaxel, those would be the 2 injectable portfolio. And then we've got a few that are partnered outside, which will be in the area of general injectables.

The next question is from the line of Shashank Krishnakumar from Emkay Global.

I think we touched upon Advair. I just wanted to check on our Symbicort and QVAR filings as well. If I've also made progress with the site transfer for these 2 assets?

Yes. On Symbicort, we have; on QVAR, we believe that Indore will be the site that we will take -- we will get approval from. So yes, on Symbicort, we have already done that.

.

The second question was on the trade generic business. Is it possible to sort of call out what was the growth rate in the trade generic business this quarter? Any ballpark number would be helpful either on a Y-o-Y or Q-o-Q basis?

I think Q-on-Q, you can probably take the One-India growth number is a good surrogate.

Even on Y-o-Y, I think Rx and Gx both grew at a similar number, the growth rate.

The next question is from Harsh Bhatia from Bandhan Mutual Fund.

Sorry to harp on this, Umang. And please correct me if I'm wrong. Abraxane, you mentioned even if the plant gets cleared tomorrow, it is 6 months to launch. Again, is there a margin of safety that we are working with, which is why we are building in 6 to 7 months period over year. Or is it because the complexity of the product is such that 6 months is the primary condition. In addition to that, are we already building in PAI to this timeline? Could you help us just understand what are those Q3 assumptions over here for the 6-month time gap?

So I think the first is that, look, there is -- obviously, it will take us time to ramp up. It's not -- once the approval comes, we will have to ramp up. We'll have to take some batches with to assure data, the API that we have is an API from -- line from a fairly long time. So we are anticipating that and have given this guidance on the ramp-up. But we are quite confident that if we get the approval, the launch is definitely going to be before the end of the year and the sooner the better.

Sure. And on Advair, just one clarification for the InvaGen facility. I think the filing is done from the InvaGen facility in terms of the site change on the site transfer. Again, over here also our launch time lines are building in an FDA inspection or they are not building in the FDA inspection?

Here, they are building in an FDA because this is a new site. 100%, they are building in an FDA.

Sure. And just one lastly, on Revlimid for FY '26 -- Jan '26 would be the period when the patent comes off. So FY '26 sales pattern is going to be similar to FY '25 sales pattern, again, very qualitatively without getting into the numbers? Or would it be very different as compared to FY '25, again in terms of the sales pattern that we are looking at?

I think it will be different. And for the right reasons, I think that the market will have more competitors. And so I think, yes, the pattern will be different.

Ladies and gentlemen, this will be the last question for today, which is from the line of Nitin Agarwal from DAM Capital.

Umang, just following up from the Symbicort partners you mentioned, what would be the rough time lines in your expectations for our Symbicort approval in the U.S?

I would say about 18 months -- we should be tracking to 18 months within a period of 18 months.

So more like a second half '27 launch?

Yes, yes.

Secondly, on the India business, we've done reasonably well over the last few years from a revenue growth perspective. I mean, if you can give us some color on -- qualitatively, how is the profitability of the business sort of changed over the years? Has it become -- has profitably improved a fair bit? And where do you see -- what kind of opportunities do you see in this business? I mean, one assumption is that typically, these are branded businesses and the business -- branded business as scale comes, profitability keeps increasing a little bit disproportionately. Is that the right way to think about it?

Yes. I think scale is a very big scale and growth is a very big driver for profitability. But we've also been taking a lot of actions about optimizing our productivity. We've been taking actions about automating our processes, about improving the way our reps detail. And in the last 1.5, 2 years, we've also expanded our sale force, right? We've added a fairly significant number of people. I think our view on India is that as the penetration in the market increases, the market offers a lot of opportunity.

So for us, yes, profitability has improved, but largely due to the fact that we've optimized our own productivity. Because if you really look at the last 2 years or 3 years, there have been hardly any price increases that anyone has been able to take. The weighted average ratio of price increases would not be higher than 2% or 3% in our case. And so we've had to drive profitability growth just out of optimizing our productivity. And that's what our team has done in our India business. And I think as a result of that, we've kind of expanded our margin and use that to reinvest for more reps in the market.

And is it sort of fair to assume that India profitability would be higher than our overall profitability numbers, should be in line with that, how should we think about it broadly?

We don't provide margin specific guidance. India profitability for -- you have to also keep in mind this year has -- Revlimid has base U.S. business. It's got India business, then there was a transition in the generics business. But it would be safe to assume that our India business profitability is slightly -- is kind of higher than the overall company average. It'd be safe to assume that.

And last one on -- in the past, you've talked about licensing possibly in Mounjaro if Lilly decides to launch in India. There are talks Lilly would be looking to launch sometime this year, accelerating their launch. Any color on by when -- if we still are there in the reckoning to become a partner for that? And how important will that be for us as a business?

Well, obesity as a category will be important because I think it's one area which is very closely related to cardiology, very closely related to metabolic. I think we want to be there on -- when the market forms. And obviously, Lilly is a very trusted partner. We'd like to believe the same of ourselves with them. But it is completely Eli Lilly's decision on who they would choose as a partner. And we have always maintained that should they need support to launch in the market, we are always available.

If I can just squeeze the last one. In the television interview, there was a flash that we talked about margins for Q3 not sustainable. So this is more in the context of Q4 being a seasonally soft quarter or there are certain elements in the Q3 quarter, which are not sustainable in the first place?

No, I don't think Cipla can do 28% margins, EBITDA margins, and that is what I had mentioned because the question was with respect to quarter whether you'd be able to do 28% EBITDA consistently. And I said, no, that's not a sustainable margin profile for us. And it's because of the mix of our respiratory season in India is because of a larger share of growth from EMEU in the previous quarter of year-on-year growth. And these type -- I don't think we can sustain that level of margin going forward. That is what I had mentioned. That doesn't -- but at the same time, we also said that we will exceed our guidance range for the current year. And based on what we had guided earlier. So 28% is not a sustainable margin for us. That's what I meant.

As that was the last question, I would now like to hand the conference over to Ms. Diksha Maheshwari for closing comments. Over to you, ma'am.

Thank you, everyone, for joining us. If you have any further questions, please write to investor.relations@cipla.com.

Thank you.

Thank you, members of the management. On behalf of Cipla Limited, that concludes this conference. We thank you for joining us, and you may now disconnect your lines. Thank you.