Ladies and gentlemen, good day and welcome to the Cipla Ltd Q4 FY 2025 earnings conference call. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing the star then zero on your touch-tone phone. Please note that this conference is being recorded. I now hand the conference over to Ms. Diksha Maheshwari, Head Investor Relations from Cipla Ltd. Thank you, and over to you, ma'am.
Thank you, Rutuja. Good afternoon and a very warm welcome to Cipla's Q4 FY 2025 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 statement, whether as a result of new confirmations, future events, or otherwise. I hope you have received the investor presentations that we have posted on our website. I would like to request Umang to take over.
Thank you, Diksha. Good afternoon, everyone, and thank you for joining us on our fourth quarter's earnings call for financial year 2025. FY 2025 marks a year of high milestones across our flagship businesses of One India, North America, One Africa, and EMU. Our One India business surpassed the landmark of INR 11,000 crore revenues, reflecting our strength in the domestic market. North America saw remarkable progress with three key new drug approvals, further solidifying our foothold in the region. Meanwhile, our One Africa and EMU businesses maintained strong growth momentum throughout all the four quarters, highlighting our commitment to sustainable expansion. Coming to our business performance, our One India business posted a healthy growth of 8% year-on-year this quarter, with a full-year growth of 7% year-on-year, driven by substantial progress across the branded prescription, trade, generics, and consumer health business.
This growth was realized despite seasonal challenges, particularly in the acute category, demonstrating the resilience and de-risk business mix in a dynamic market landscape. In our branded business, our key chronic therapies of respiratory, cardiac, and urology continue to outpace market growth. Our overall chronic mix further improved to 61.5% as per IQVIA MAC 25. For our quarter, our leading inhalation brand became the first brand in the history of IPM to cross INR 9,000,000,000 crore reaffirming its position as a market leader. This year, we expanded our presence in the IPM by adding four brands with revenues exceeding INR 1,000,000,000 crore bringing our total to 26. Additionally, we have increased our footprint to the top 300 ranks, where we have 23 brands in the top 300 ranks. During the year, Cipla took strategic strides in expanding its portfolio through key partnerships with global players.
We collaborated with Orchid Pharma for Cefepime and Enmetazobactam. In India, we joined forces with Takeda to bring Vonoprazan, and we signed a multi-regional licensing deal with Formosa for Clobetasol suspension. To elevate our offerings, we will be launching innovative products like inhaled insulin and plasminogen, and are backed by a good pipeline of high-potential assets in various stages of development. Our trade generics business continued its upward trajectory during the quarter on the back of vigorous execution and distribution, new launches, and technological advancements. Expanding our portfolio remains a key pillar of our growth, with 19 new introductions this year, further elevating our market presence. Our consumer health business delivered strong double-digit growth for the quarter as well as FY 2025. Our anchor brands of Nicotex, Omnigel, and Cipladine maintained leadership positions in their respective segments, securing the number one position in the market again.
North America business achieved a quarterly revenue of $221 million, with an all-time high annual revenue of $934 million, propelled by strong traction in the differentiated portfolio and consistent demand for our base business. Our albuterol market share remains steady at 18%. This quarter, we have begun to see supply normalization for Lanreotide, and we remain optimistic about reaching the previous level from the earlier quarters. Additionally, apart from receiving a number of smaller approvals, we obtained two significant drug approvals this quarter: Nano Paclitaxel ANDA and the Nilotinib NDA approval. We have already launched and started selling Nano Paclitaxel in a couple of EMU geographies and are hoping to do the same in the U.S. soon. Our One Africa business grew at an impressive 15% year-on-year during the quarter, with a full-year growth of 12% year-on-year in USD terms.
In the private market, our secondary growth outpaced market growth at 6.7% versus 4.9%, enhancing our competitive edge. North Africa also recorded robust growth during the quarter, fortifying our presence across the region. In our EMU business, a strategic focus on deep market penetration has established a solid foundation, delivering a quarterly revenue growth of 16% year-on-year and an annual revenue growth of 15% year-on-year. After four years of stable performance, our EMU business is now entering a phase of growth. This performance was led by expansion across both DTM and B2B categories, alongside consistent margin stability and internal pipeline assets. I'd like to update you about our U.S. pipeline. We remain committed to organic investments with a strong focus on R&D for the U.S. market.
In respiratory, we have filed six assets, including Symbicort and QVAR, the generic versions of both, with launches expected in line with the review process. Four more respiratory assets will be filed in the next 12-18 months. We are now closer to commercializing generic Advair and are pleased by the promulgation signed by the administration for approving launches from U.S. facilities faster. In peptides and complex generics, nine assets are already filed and with some launches projected FY 2026 and 2028. We aim to file 10 more peptides and complex generic assets in the next 12-24 months. We remain committed to launching two to three peptide assets in FY 2026.
Coming to the regulatory front, as you're aware that during the year, the U.S. FDA audited five of our manufacturing facilities based in India at Patalganga, Kurkumbh, Goa, Virgonagar, and MediSpray, and all of these inspections have been classified as VAI. This accomplishment reflects our dedication to quality, compliance, and operational excellence. I would now like to invite Mr. Adukia to present the financial and operational performance.
Thank you. Thank you, Mr. Vohra, and good afternoon to all. I'd like to present the key financial highlights for the quarter and the financial year 2025. As highlighted earlier in other quarters as well, this is adjusted for QCILS numbers. In the early part of the year, we had issued a range of performance, which we are happy to inform that we have now executed as per plan. We are pleased to report a quarterly revenue of INR 6,730 crore, with a healthy YoY growth of 9%, driven by our focus markets. As a result, we ended the year at INR 27,548 crore, with revenues growing 8% YoY. The EBITDA margin stood at 22.8% for the quarter, higher by 150 basis points YoY, and 25.9% for the year, marginally exceeding our guidance, which was higher by 139 basis points YoY.
As per practice, this EBITDA margin does not include the other income. Gross margin after material costs stood at 67.5% for the quarter, which is 74 basis points above last year's figure. The gross margin for the year stood at 67.6%, which is higher by 150 basis points, so 157 basis points YoY . Expansion and profitability is largely due to favorable mixed calibrated price actions across branded and generic portfolios and impact of easing cost escalations. Total expenses for the quarter include people costs and other expenses, which stood at INR 3,003 crore, higher by about 7.4% on YoY basis. Annually, the expenses were INR 11,491 crore, higher by 8.7% YoY. The R&D investments for the quarter are at INR 426 crore, which is about 6.3% of revenue, driven by product filing cost developmental efforts. Overall, for the year, the R&D investments stood at INR 1,524 crore, which is at 5.5% of the revenue.
For the quarter, PAT stands at INR 1,222 crore, representing 18.2% of sales, with the effective tax rate of 18.6%. On a full-year basis, PAT amounts to INR 5,273 crore, accounting for 19.1% of sales, and the effective tax rate for the year is 22.4%. The slightly lower ETR in FY 2025 is due to reversals of previously recognized tax provisions and certain other adjustments. Even after adjusting for this impact, PAT continues to grow strong, double-digit growth for the year, reinforcing the company's solid financial performance. Our ROIC continued to be strong at 30% + for the year. Our free cash generation and operating efficiency endures to drive healthy cash net position. As of the year-end, debt on our balance sheet, including the lease liabilities, stood at INR 438 crore, with net cash equivalent balance after adjusting for debt at INR 10,369 crore.
Looking forward, our key focus areas for FY 2026 will continue to be 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'll further work on cementing growth levers for wellness portfolio, including ramping up our new launches. In North America, our focus would be maximizing the commercial execution and expediting our new launches. In South Africa, as was the year before, our focus will be margin expansion. EMU, our top priority, is to maximize top line with focus on deepening our penetration in identified core markets while sustaining our strong margin trajectory. In terms of our FY 2026 guidance, our business model and product pipeline remains resilient, leading to our revenue trajectory continuing in the growth path. This is despite the generic Revlimid losing its exclusivity during the year.
Our outlook for projected EBITDA margin is in the range of about 23.5%-24.5%. That's it from my side. Thank you for your attention. Now I'll request the moderator to please take the questions.
Thank you very much. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchstone by the telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets and also to restrict the questions to two per participant. Ladies and gentlemen, we'll wait for a moment while the question queue assembles. The first question is from the line of Dr. Kunal Dhamesha from Macquarie. Please go ahead.
Hi. Thank you for the opportunity. The first question on the Nano Paclitaxel launch that we are anticipating in the U.S. in the near term, Umang, how are we looking at this market given there are other players with a 505(b)(2) kind of product? With our product, how are we positioned to gain market share? If there are any technicalities regarding a particular channel of selling, if you could highlight those aspects, it would be great.
Sorry, we were on mute. Bulk of the market is, I think there are what we know, there is one NDA player, and there are two generics. I think one of the generics is any. We will continue to expand for ANDA generics because they are substitutable. Actually, from a reimbursement perspective, it is our belief that everybody is reimbursed like a generic. We feel that the market is large enough for us to take meaningful share.
What would be your estimate of the total addressable market now?
No, at least the market was $800 million-$900 million pre-generic. I think the IMS would still show it at that level, but there would be a gross to net to bring the market down, which typically is not very high on the institutional side of the business. That is where, unlike the retail, where the gross to nets are really high. Here, the gross to net is going to be very significant. I mean, it is going to be closer to the overall IMS reported number. Our belief is that we should play for fair market share on this product category. I would not be too surprised if our share reflects that.
Sure. That's great. Secondly, I think I missed any commentary on Advair and overall on the respiratory pipeline that we suggested. Could you please?
Advair, as we mentioned, will be commercialized from our site in the U.S. The product, obviously, we've taken our batches and we've gone through the regulatory process. I think depending on how the U.S. prioritizes domestic site filings, we definitely see it as an FY 2026 launch. The question is, depending on the priority of the filing, we will probably either be launching it in the early part of the year or the later part of the year.
Sure. So we have filed an amendment to ANDA, right, and not the CB30?
No, no. It can't be a CB30 because it's from a new site. That filing has already gone where it is a filing from a new site. It can't be a CB30. I think there was a recent promulgation from the U.S., which said that when you make filings from domestic facilities, right, then your files may be prioritized. We have yet to see what happens basis that to this file.
Sure. Thank you. If I may, one more on the potential pharma tariff. Is there any update on your side in the U.S. market? If you are getting something from your partners or distributors, any color would be helpful there.
Actually, Ashish is closer to those discussions. So maybe Ashish, you can give a view on that.
Yeah. We have not in any way got impacted by any. This is an evolving situation. We have to yet see on what gets decided finally. In our portfolio, we've not got impacted. I think the most recent announcement does not really impact the generic players. In fact, it may just benefit. We have yet to see this evolving situation.
Sorry to interrupt. May we request Dr. Kunal Dhamesha to please rejoin the queue? We have other participants waiting for their turn.
Yeah. Thank you.
Thank you. Ladies and gentlemen, in order to ensure that the management is able to address questions from all participants, please limit your questions to two per participant. If you have a follow-up question, you may rejoin the queue. The next question is from the line of Damayanti Kerai from HSBC. Please go ahead.
Hi. Thank you for the opportunity. My first question is on Lanreotide. Umang, you mentioned you have started supplies to a few markets. If you can talk, sorry, for Lanreotide, how should we look at the normality or, yeah, normality coming back in the supplies for the U.S. market?
Yeah. I think my comment in the script was more about Nano Paclitaxel.
Yeah, sorry.
Nano Paclitaxel, we are, yeah, Nano Paclitaxel, we've already supplied to a couple of markets, and we are ready to supply to the U.S. as well. I think on lanreotide, as I mentioned, this quarter is the quarter that went by. Quarter four was significantly higher than quarter three. And in terms of volume, and also this quarter, we are coming back to normalcy. I think our mix of products is something that we are managing, but the product is quite significantly back into the channel.
Okay. So in first half itself, should we assume it will go back to the level where you left?
Yes. I mean, remember that that level was built as a common strategy between the NDA product and the ANDA product. For some time, the ANDA product took over, and that was, and now we're coming back into both the NDA and the ANDA. Eventually, we will reach that level if that's your question.
Sure. And just a related thing, which product will you prefer? The NDA one, like the 505(b)(2), or NDA in terms of gaining market share quickly in the market?
No, I think the ANDA always gains share faster because it's just, it's like the brand product. We are selling both right now.
Okay. My second and last question is if you can comment on your R&D outlook. Fourth quarter, in general, I guess, is more than what we saw in the previous quarters. It could be lumpy. In terms of spending the 2026, 2027, how should we look at the R&D cost? Which are the focus segments in near term?
I think we are generally in the range. I think we are really guiding to not being ever higher than 6%-6.5%, right? That is for a full year basis. Some quarters may be slightly higher than that. Some may be lower, right? Overall, we never do R&D more than that because that is what our business model allows us. Quite honestly, we do not need spending more than that basis our pipeline and our portfolio. Focus areas will continue to be respiratory, will continue to be injectables, will continue to be products in the products which are for India, including the GLP-1s that are going to go off patent.
Okay. Thank you. I'll get back in the queue.
Thank you. The next question is from the line of Surya Narayan Patra from Phillip Capital India Pvt Ltd. Please go ahead.
Thanks for the opportunity, sir. My first question is on the hello.
Hello.
Hello. Am I audible?
Please go ahead, sir. You're audible.
Okay. Thanks for the opportunity. First question is on the margin guidance what we have given. It looks like slightly lower than last year number. Is it because the Revlimid number is likely to be lower, or is it because Revlimid is started seeing any kind of price correction in the last 12-month period of the given block?
Yeah, sure. I can take that question. No, it's not the impact of, like we mentioned, the revenue will continue to be in the growth trajectory. It's basically a mix that is likely to change. One of the key reasons is generic Revlimid, which will go out of exclusivity towards the last quarter. That will certainly have an impact on overall margin. That's why we are guiding towards the margin number that we've given. Yeah. Maybe if I can just add to what Ashish said. I think in the current year, just to be in all transparency, we have possibly exceeded what we gave as a guidance range. If you, Ashish's commentary was about 150 basis points from where we guided, is where EBITDA is higher, right?
If you were to just take the 150 basis points out, we're broadly in the same range that we had communicated as a possible guidance range for the last year.
Okay. Second question is about the CapEx for FY 2026. What is our thought process there? For the peptide as well as the GLP opportunity, how prepared are we? Also, a last question, since it is the final year, meaning the fourth quarter result that we are discussing, what would be the overall respiratory revenue that we would be making out of the consolidated revenue? If you can give that number, please.
Okay. I think there are probably three questions in that one question. Let me start with the first one on CapEx. If you see in the last couple of years, we've actually increased our investments on the CapEx side. These are all very strategic calls that we are taking to actually increase our capacities in respiratory capacities. Most of the CapEx that you see are actually growth CapEx that are oriented to increase the respiratory capacity in MDI, DPI, and rescues. Other than that, we also have our CapEx oriented towards de-risking to the outside India facilities. We had the China facility that got capitalized recently, and the product supply has started from there. We have both facilities in the U.S. getting ready to start supplying MDI and DPI from there.
You have a large maintenance CapEx as well, which is ongoing. That has been our CapEx strategy. It is all oriented towards our strategic plan that we have in the future. On your second question, which was on GLP-1, I think Umang has covered in the past that we will be ready whenever there is a first wave of launch that will come through. We are looking at both in-house as well as third-party partnerships out there to make sure that we are in the first wave of launch. Your third question.
Was about the respiratory revenue share.
Oh, yeah. See, respiratory is one of our top strategic, continues to be our top strategic pillar. We continue to be 30% kind of a revenue overall that comes from respiratory on a global level. That's what we track very closely.
Okay. Did you share any number for the CapEx for the next year?
No.
No.
About 4% roughly or 5% of your revenue, yeah, somewhere around that would be the figure for the CapEx, 5% of revenue you could take.
Gotcha. Yeah. Thank you, sir. Wish you all the best.
Thank you.
Thank you. Participants are requested to please limit their questions to two per participant. The next question is from the line of Neha Manpuria from Bank of America. Please go ahead.
Yeah. Thanks for taking my question. Umang, on the India market, now that the trade generic restructuring that we were doing is behind, if I look at this year, obviously that was impacted by seasonality, how should I think about growth? While we have mentioned higher than IPM growth, what's your overall sense on what the market growth can be there for what the trade generic and branded generic growth for Cipla could be?
I think I was just mentioning this a little earlier to someone else. The overall market growth rate range of 10%-12% has now moved to 8%-10%. The reasons for that is that we've gone through a pretty superlative new introduction movement in the market because you had everything going off patent. Apagliflozin, Empagliflozin, right? You had Sacubitril, Valsartan. A lot of products went off patent, and therefore NI growth actually went up. Therefore you lost, right? Compared to that, and now you'll see possibly 1%-1.5% lower future growth due to the fact that the NI season, as you may call it, of expiries is gone. The second aspect is inflation used to be higher, so companies were given pricing adjustments, which was at inflation then.
Inflation numbers are now lower, so you lose another 1%, 1.5% there. What was a 10%-12% range is now somewhere in the 8%-10% range going forward for the industry. Cipla will do better than that overall in India.
Understood. In trade generic, we have regained all the whatever lower volume that we have. It is fully back to normal.
It is fully back to normal, and the whole distribution channel now is completely internalized to Cipla.
Understood. My second question is on capital allocation. Given the cash that we are sitting on, I know you have indicated in the past, but as you just refreshed to what your priorities are, has there been any changes in terms of where you'd look at opportunities inorganically to deploy that cash?
Yeah. I think, again, we see India as our growth market, and I think it always gives you a good return on capital as you invest capital in India. We have invested on people. We have been investing on CapEx that I talked about. We will also continue to look at small to large M&A opportunities out there, which can come in the form of not just companies, but product portfolio, etc., that we may acquire out there. I think the second opportunity that we see is always adding to the portfolio in the U.S. We keep looking at partnerships where we can acquire complex generic ANDAs or NDAs, which requires you to pay some sort of milestone upfront, but then the asset is yours, and you start to commercialize those assets. Other than that, EMU, we look at opportunistically acquisitions out there as well.
It will not be large in size, but more mid-size kind of an opportunity that we will invest in. We have many avenues to look at from a capital allocation point of view. You would have seen that we have also accordingly maintained the dividend that we had increased in the last two years.
Thank you so much, Ashish.
Thank you. The next question is from the line of Shashank Krishnak umar from Emkay Global. Please go ahead.
Hi. Thanks for taking my question. My first one was on the partnered inhalation asset, which we had filed a few quarters back. Just wanted to check if we are on track to commercialize this asset sometime next year. Also just wanted to check which facility is this asset now filed for.
Yeah. The asset is on track for commercialization. The asset was originally filed from Goa. It will be commercialized from Goa. We are also creating a new filing for, we are also supplementing the file if needed by also having the option of doing this from our U.S. facility.
Got it. Thanks. My second question was on the domestic business. I think we mentioned in the opening remarks that the consumer health business saw double-digit growth this quarter. Would it be fair to assume that the trade generic business also grew in double digits this quarter?
No, I don't think so. I think the trade generic business did not grow as much as the consumer health business. It did not grow double digits. Yeah. Trade generic business, if you see YoY basis, okay, the model change that happened impacted quarter one of FY 2025. Quarter four was broadly a normalized quarter of FY 2024. Therefore, the YoY growth out there in trade generic is a normal growth that you would see. Yeah.
Gotcha. Gotcha. Thank you. That's helpful. Thanks.
Thank you. The next question is from the line of Sidharth Negandhi from Chanakya Wealth Creation. Please go ahead.
Thank you for taking my question. This was again on the domestic business. How are you thinking of the schedule extension that was given up to 31st December for MSMEs in context of whether that can be a tailwind for further growth on the trade generics business as well as the branded generics business? Do you see that tailwind coming in should that implementation happen? How are you thinking whether that is likely to happen?
No, I don't think we see that as a big driver for our growth. In fact, I think not having the ability to create more uncertainty in the market. I don't think we see that as a big headwind, as a big tailwind for us this year.
Thanks. The second question was on what you mentioned about the recent most U.S. regulations, right? Now, while it is an advantage for generics as far as MFN is concerned, given certain parts of the portfolio, at Cipla is also specialty. Does that most favored nation policy create any impact on that specialty part of the portfolio?
We do not have too much share of new drug spec. I think the focus of the legislation is on new drug spec as against simple 505(b)(2)s, which are either with different salt forms or with different delivery systems. Because most of those 505(b)(2)s are reimbursed in the same manner in which the ANDAs are reimbursed. I think the focus of the legislation is on new drug NCs and new drug products, and we do not have those.
Yeah. Thank you. Thank you very much.
Thank you. The next question is from the line of Devang Sha from Asit C Mehta Investment Ltd. Please go ahead. Mr. Devang Sha, please go ahead with the question. Your line is unmuted.
Hello?
Yes.
Yeah. Am I on the good?
Yeah. Am I on the good? There is an echo from your line.
Just I want to know that the way you have mentioned as far as your EBITDA guidance, as far as overall revenue for next FY 2026, can we expect that your top line is going to go in the range of 7%-9% kind of thing? The way you already mentioned that you are going to continue the same growth trajectory. I'm just talking about the overall growth will be in the same range as far as top line revenue is concerned?
Deva, we do not give revenue guidance, and then we usually every year give EBITDA margin guidance because our focus is on profitability to ensure that we maintain that. That is why we continue to give the profit margin.
Okay. My second question, the way the U.S. in which the situation somewhere right now evolving related to pharma-related aspects, can you throw some light that it is going to affect our U.S. business or we do not have any kind of challenges due to that?
No. I think there are two things that are happening in the U.S. One is the tariffs for which right now there are no tariffs on generic products from India by and large and from actually a lot of countries other than perhaps one odd country. I do not think we are impacted by tariffs as yet. We do not see the market just being very different in the future on that. The second one is the recent executive order on pricing reductions that companies are to voluntarily take. I think that is generics, quite honestly, is a beneficiary of that order because it creates a market where generic drugs would be preferred. We are not seeing this in, we are not seeing that impacting our business at all.
Okay. Thank you, sir. Okay.
Thank you. The next question is from the line of Beno Parthi Parmar from Lara Capital. Please go ahead.
Hi. Good afternoon. Um, are we still expecting to launch Cipliqord in FY 2027?
27, yes. We should be hopefully there.
Okay. There is this product, Semaglutide, in which you and your partner have filed for a declaratory judgment. Could you give some details about when do you expect to launch this?
Actually, Beno, I would rather not. I would rather not provide since the product is competitive. I think it's, but if you follow the, if you follow the court and what the summary judgment is being, or the DJ is being asked for, I think you might be able to figure it out. So, yeah.
Understood. Okay. And if I can put it this way, I believe the product has an off-and-drug exclusivity till May 2026. Is it likely before that or after that?
Yeah. I think you're on the right track, Benough. You're on the right track.
How?
Yeah. I think you're on the right track, and it might be a little bit longer than that also, after that also.
Got it. And finally, with Lanreotide coming back, are we looking back to getting to our peak U.S. run rate of $250 million a quarter starting next quarter or something like that?
If Lenalidomide might stay at where it was now, yes, we would have got there and crossed it. You also have to see the next two or three quarters is when we will see a compression in Lena. That will be offset by these new products that are coming up. Our current guidance range is different for the overall U.S. market. We do not comment specifically by product, but as of now, we are looking at something like $220 million for the U.S. going forward in the next quarter or so.
Sorry, you said 220 around?
That's right. For the next quarter, considering what we know is going to happen to Lena, etc.
Got it. Okay. Thank you very much.
Thank you very much.
Thank you. The next question is from the line of Dr. Kunal Dhamesha from Macquarie. Please go ahead. Kunal Dhamesha, please go ahead with the question. Your line is unmuted.
Yeah. Thank you for the opportunity again. Just one clarification on Lanreotide. We said that by quarter one or the current quarter, we have enough product in the channel to reach the previous market share. Is that correct understanding?
No, I don't think we said enough product in the channel. I think we said we have resumed our supplies back. The channel, quite honestly, does not have too much product of Cipla because we are getting back into the business. Right now, we are projecting enough supply to be able to start building towards that range.
Okay. So basically, our revenue ramp-up would be more or less in line with our market share ramp-up. Is that the correct way to understand?
Yeah. Let me probably say that we are right now at a stage where we are beginning to produce to roughly the same levels that we used to produce when we had the market share that you have in mind. From that level to go to that market share, because we have to keep a little bit of stock spare as well as fill the pipeline and fill the channel, it will take a little bit of time. Production is roughly coming back to the level that we used to have when you saw the market share you have in mind.
Okay. Great. Thank you for that clarification. Another clarification on Advair, when did you file the amendment to the U.S. FDA?
I don't think we are giving that level of guidance specifically because, again, the product, the launch timelines can be calculated from that perspective. I can just tell you that it's already in to the FDA and it's been filed.
Sure. Lastly, the three peptide acids that we expect to launch in FY 2026, any indication as to how should we think about the size of these products with respect to the currently launched peptide products?
Ashish, you may have better color on this. Yeah. Sorry. You want, no, it's peptide. Three peptides. Yeah. I think we're not giving guidance of size, but one of them is likely to be a large asset for us. The other two would be smaller assets.
Sorry to interrupt. May I request Kunal Dhamesha to please rejoin the queue? We have participants waiting for their turn.
Sure. Sure. Thank you. All the best.
The next question is from the line of Anugrah from UBS. Please go ahead.
Yeah. Thank you. One question on Nilotinib. I'm just trying to understand this as an opportunity. Is it a $10 million-$20 million opportunity revenue size or?
Sorry to interrupt you. Mr. Anugrah, can you speak a bit louder? We are unable to hear you clearly.
Yeah. Sure. I repeat my question. First, checking, is this okay? Am I audible now?
Yes, you are. Please go ahead.
Okay. Thank you. First question is on Nilotinib. Just trying to understand how big is this kind of opportunity? Is it on revenue roughly about $10 million-$20 million opportunity annually, or this can be a $20 million-$50 million scale opportunity? Just trying to understand this.
Anugarh's not giving product-level guidance or specifically on this, but there are multiple factors that can play out on this. I think they are related to how soon an ANDA enters versus how soon a B2 product can exist.
You will be launching this product when?
It's imminent.
Just on the U.S. sales, last year we did $934 million. When do you expect to reach this level in, let's say, FY 2027, 2028, 2029? When would you again reach that level, roughly?
The hope will be to obviously reach the same level. Depending on the challenges in the market, we do not think that there is enough definitive and predictive analytic to suggest where we will reach because Lena is fairly significant. It depends on how the Lena trajectory unfolds in the U.S. We have given you a range for next quarter. I think if you use that and add some of our new launches and take an estimate of where Lena goes, you might be able to come to a conclusion.
Thank you. Just one last question on the semaglutide in India market. When you launch it, would you be pursuing both the tablet and the injectable versions there or only one of them?
We will be in whatever variant forms for the market. I think it might be that it'll likely be the injectable first. I think we'll definitely be in that. Also, as and when the market opens for the oral, we'll also be there in that.
Okay. Thank you.
Thank you. The next question is from the line of Sanjay Kohli from Gold Stone Capital. Please go ahead.
Yeah. Hi. Thanks for the opportunity. This executive order, when does it get implemented? It is very interesting that you said that generics will actually benefit out of it because if the innovator prices are, if it is going to really target the innovator pricing, then just give some, can you give some color on this?
Mr. Kohli, sorry to interrupt you. Your voice is sounding very muffled, sir.
Muffled. Okay. Better now?
What is happening? There is echo also, which we are getting from your line, sir.
Just a second. Let me come near the window. I get a better signal. My question, am I audible now?
Yes. Yes. Please go ahead, sir.
The question is directed about the executive order, which is proposed. How quickly do you expect this to get sort of implemented? Just on a voluntary basis, could you give some color on this and how it affects pricing on generics?
Right now, we do not think it affects pricing on generics. We think that the executive order is probably more towards branded drugs as against generic medicines. We believe that in the long run, generics will be a beneficiary to this.
How?
Look at it this way that if your overall prices are promulgated to reduce, why would branded companies be interested in spending massive amounts of promotion, etc., into it? Therefore, the newer, the categories of drugs that cannot be, they may actually move over to those drugs which are already generic.
Okay. Doesn't it?
Thing that the newer branded, yeah. Go ahead.
Would it mean that the system is recognizing a certain inefficiency in the whole, also innovator? That is also likely to, they're likely to, something to be happening there also for lowering the cost?
I wouldn't know. Look, I think right now, it's been one day since the order's come. They're also digesting it. Maybe we'll be in a better position to speak about it over the period of the next month. It's too recent.
Okay. Thank you.
I wish they could launch it after our earnings call today.
Thank you.
It's got a lot of questions on it with me. Really don't know much about it. Sorry.
Can I get in slip in another question, please, on the proportion of your U.S. sales? How much of it do you manufacture in the U.S.? Close to $1 billion.
Every year. Yeah. About 25% comes from the U.S. Right now, it's mainly orals. We'll be adding, like I said, MDI and DPI as well. Roughly about 33%, a third roughly, comes from India currently. The balance, we have CMOs, etc.
Yeah. No, no. My question was, of the 29% of North American sales, what percentage of that is supplied by our facilities over there?
Yeah. Yeah. That's what I'm saying. If you, so 25%-30%, like I said, it's one-third, one-third, one-third of U.S. sales.
Right. Got it.
One-third of total U.S. sales. For the 29, let's say 10% will be made in the U.S., right? And 10% is in India and 10% is the rest of the world.
Okay. Got it. Thank you so much.
Thank you. The next question is from the line of Krishna Sanghavi from Quantum Mutual Fund. Please go ahead.
Yeah. Hi. I'm just adding the question. Quickly, on the India piece, the 7% YoY growth, is it largely attributable to volume growth? Hello?
Hello?
No. At least a mix of all three. If your question is whether the volume growth is majority in India, no, I think pricing is also there. And so is new introduction. No, I do not think it is all volume.
Okay. Just one more thing on China. The plant you said is supplying. What does it exactly supply? Who? Which region? Any color on that?
It's a respiratory plant. It supplies respiratory medication. It's built with the intention of supplying the China market and other markets that require that product, including the U.S. if required.
Will this include the future filings also which you target for the U.S.?
Not really. This is only for the current filings. The future filings are going out of our sites in the U.S. and India.
I'll try to understand.
Yeah. The China market itself is also quite big for the type of products that we will be managing.
I see. And just a double check on the revenue limit. Have you filed for, sorry, not revenue limit. I mean, SEMA. Have you filed for Canada or some Brazil markets?
No. We have not.
On the revenue limit, do we get any volume increase this year?
Mr. Sanghavi, may we request you to please?
Yeah. Yeah. That is the last question if you can.
Please go ahead.
Yeah. So yeah. I think if your question is, has there been a volume increase as per this? I think for us, very marginally compared to some of the other players who had huge amounts of who have commented on larger volume share. For us, it's very marginal as per the agreement that we signed with them.
I see. I see. Thanks. I'd wear market size, we can't see. That's it. Thanks.
Thank you. The next question is from the line of Nithin Agarwal from DAM Capital. Please go ahead.
On the European emerging market business as well as South Africa, we've had a pretty strong recovering growth this year. How should we look at these markets from here on? Is something really changed in these businesses?
See, I think South Africa, there are a couple of portfolios that helped us to grow at those numbers. Three levers actually. Let me put three levers out there. One is the actor acquisition that we had made that helped us to grow out there on the OTC side primarily. Second is some opportunistic tenders that we did out there, which also helped us to grow out there. The third is new launches that we've been doing. Our new launches share has been higher than our competition. That has actually also helped us grow. Overall, if you look at the market, it's a 4%-5% growth market.
I think on a normalized basis, we should take 4%-5% kind of a growth for South Africa and not necessarily the beating growth that we've done because our focus will also be on the profitability there. EMU is a multitude of many markets. Therefore, it is difficult to give a number because there will be different growth rates in different markets. I think last year, we focused a lot on execution, which has helped us to achieve a 15% growth on USD terms. Like we've said, it has entered the growth phase. Next year, also our target is to actually grow in that market.
Thank you. Secondly, on the U.S., with the guidance that you put out of $220 million thereabouts for Q1, do you see a lot of the impact of Le na actually getting factored probably in that number? With some of our bigger launches coming through the year, do we see this number picking up as we go along, or is this a number which potentially can go down further depending on how Lena plays out?
I think Umang has covered that question. I think we are not giving guidance right now beyond quarter one for U.S.
Okay. Thank you, sir.
Thank you. The next question is from the line of Tushar Manudhane from Motilal Oswal. Please go ahead.
Yeah. Thanks for the opportunity. Just on the third passage, if you could elaborate in terms of the investment done till date as far as R&D or manufacturing is concerned and what kind of investment we are targeting for next two to three years?
Ashish Bhai, peptide is a lot of our peptide portfolio. We go outside to the CMOs. Like we said, that we do not have injectables facility. Therefore, a lot of our investment is on the development side on peptides. There are three or four broad categories of R&D expenditure that we have. Peptides is one of them. Respiratory bio is there. Then there are other complex and long-acting injectables, etc., that we have. It is part of the R&D expenditure that we incur.
One last.
Yeah. Go ahead, please.
In the earlier comments, you referred to some large assets. Maybe we can be there for FY 2026. So this approval, what is it? If you could share the expected timeline for the approval for this product?
No. I think we have two, three products which are peptides which we are expecting this year. Then we have just recently been given the approval of Nano Paclitaxel. There are a few others that we have in our pipeline. We are hoping that these approvals can come in the second half of the year. I mean, they will come as they are approved in the first half and second half. Some of the, you will see the full impact of a lot of these products in our second half of the year numbers.
Understood. Thanks. That's it from me.
Thank you. Ladies and gentlemen, this will be the last question for today, which is from the line of Vishal from Systematix. Please go ahead.
Thanks for the opportunity. Hope I'm audible.
Can you speak a little louder? Sorry. Go ahead.
Yeah. So basically, my question is on the inhaled insulin.
I'm sorry to interrupt you, Vishal. We are unable to hear you. Can you speak a bit louder?
Hello. Is this better?
Yes. Much better. Please go ahead.
On the inhaled insulin that you got approval for in the last quarter, just wanted to get the sense on the opportunity size. How are you going to price it versus the other injectable insulin? Largely because the asset has not done well globally. Anything that you can kind of make it work in India?
I think obviously, on pricing, etc., we have an idea of where the market needs to be. I think we are working towards that. I think the launches somewhere around should hopefully follow in three to four months. We have a market plan for this. The idea of inhaled insulin is never to replace the way insulin is served in the market in India. By its very nature, the asset is a niche asset for people who cannot take injectable drugs or people who are hesitant to take injectable drugs. That is the reason and the niche where it will be positioned. It is not a mass product. I do not think the product needs to do hugely well in any market because it is not intended to do that. It is intended to serve a section of population and an unmet need for that population.
Okay. All right. So kind of any number as to can it be a low single-digit market share product in terms of volumes?
The overall insulin market, yes. Probably that's where it will end up. It's not going to be a huge market share product. The insulin category is huge. Our research says that there is a list of people who have injectable phobia and who might actually benefit from inhaled insulin.
Right. Thank you. Just a follow-up on GLP-1, have we initiated the clinical trials for the India markets?
As I mentioned, we will be on the day of the market creation.
Okay. Thank you.
We are not giving specific detail on the product per se right now.
Got it.
Thank you. Ladies and gentlemen, that was the last question for today. I would now like to hand the conference over to Ms. Diksha Maheshwari for closing comments.
Thank you, everyone, for joining in. If you have any further questions, please write it to investor.relations@directcipla.com.
Thank you.
Thank you. On behalf of Cipla Ltd, that concludes this conference. Thank you for joining us. You may now disconnect your lines.