Please note that this conference is being recorded. I now hand the conference over to Mr. Ajinkya Pandharkar. Thank you, and over to you, sir.
Thank you, Sagar. Good evening, and a very warm welcome to Cipla's Q4 FY24 earnings call. I'm Ajinkya Pandharkar from the investor relations team at Cipla. Let me draw your attention to the fact that on this call, our discussions will include certain forward-looking statements, which are predictions, projections, and other estimates about future events. These estimates reflect management's current expectation 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 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, Ajinkya, and good evening to everyone. Thank you for joining us for our fourth quarter earnings call for financial year 2024. In FY 2024, we recorded our highest ever revenue and EBITDA , including major milestones across our flagship businesses of One India, North America, and South Africa. Our One India revenue reached its threshold of INR 10,000 crore, North America crossed $900 million, and South Africa reached the top spot in prescription business in the country. To make this journey sustainable, we are continuing our investments across the complex pipeline, the CapEx, the big brands, and the operations. I'm pleased to share that we finished this fiscal with significant progress in our top priorities. Our first priority, we continued market-leading growth in our focus markets.
Our One India business posted a healthy growth of 10% for this year, propelled by traction in the branded prescription and trade generics, while consumer health was impacted by seasonally slower market. Our branded prescription business continued to outpace the market growth in this quarter, with Cipla growing 100 basis points ahead of the market as per IQVIA Q4 FY 2024.
This performance was largely backed by respiratories and cardiac therapies, which grew 10% each respectively. Chronic therapies now have a share of 61% in the portfolio, higher by almost 100 basis points year-on-year, and grew at 10% year-on-year versus IQVIA mapped March 2024. To improve our offerings, we were adding a niche set of innovative products like inhaled insulin, plazomicin, et cetera, in our portfolio. We have a pipeline of similar assets, which are currently under various stages of development.
In this fiscal, our trade generics recorded a double-digit year-over-year growth, further consolidating its leadership position in the market. Strong execution in key therapies, deepening distribution network in tier 2-6 cities, and 40-plus new launches, as well as technological interventions, were the key drivers for the growth this year. With a view to consolidate our distribution channel, we recently changed our model to increase the direct touchpoints, which will help us with improved trade visibility and will position us closer to the market.
We are confident that this change will help us unlock the immense potential in the trade generics market in India. The consumer health franchise was flat year-over-year in a year adversely impacted by seasonality, while operating profitability continues to be sustainable. Recent improvement in the demand cycle and in organic investments will help this business scale up further in the upcoming fiscal.
In North America, we reported an all-time high annual revenue of $906 million, which was 24% growing over the previous year. The performance was led by traction in differentiated portfolio and sustained demand for the base business. In lanreotide, we have scaled the product to achieve a market share of 20.8%, as per IQVIA Feb 2024 , which itself is a benchmark 505(b)(2) market. In albuterol, our market share was in the range of 12%-13% at the end of the year.
We have a strategy in place to improve this market share by a few more percentage points. The market share has already increased to 15.5% as per the prescription data for April 2024. Overall, we continue to be one of the fastest growing among the top five TI companies.
Recently, we achieved a leadership position in the pharma prescription for the South Africa market as per IQVIA March 2024. Here again, we recorded 11.2% year-on-year growth in secondary versus a market growth of 2.1% as per IQVIA March 2024. In OTCs, we have fastest growth amongst the top five players in the market and aspire to be ranked number two in the near future. Our second priority has been about investing in the future organically and inorganically. Our organic investments have been focused towards investing in R&D, primarily for our U.S. markets. In respiratory, we have filed five assets, including Symbicort and generic Qvar, with launches expected within three years. Further, we are targeting to file two respiratory assets with significant revenues in the next 12-15 months.
In peptides and complex generics, 12 assets were already filed with most launches in 2-4 years. As alluded earlier, we strive to launch 4 peptide assets in FY 25. We are also working on several 505(b)(2) opportunities in complex and our products, which are currently in the development and will lead to our future portfolio. For inorganic partnerships and investments, we have been very mindful of the choices to allocate capital. Earlier this year, we invested in Actor Pharma, which stands fully integrated as of date and is expected to help accelerate our South Africa OTC portfolio for FY 25. Recently, we entered into a marketing and distribution partnership with Sanofi to expand the reach of CNS portfolio in India, in line with our focus to enhance our chronic portfolio.
In Cipla Health, we entered into a brand acquisition for the cosmetic and personal care business of Ivia Beaute Private Limited, which includes their flagship brand, Astaberry, to bolster our India OTC portfolio. During the year, we disinvested our QCI portfolio and focused on allocating our capital to other growth projects while we continue to serve Africa through our global access business. In the past year, the US FDA audited three of our facilities based in the US and issued either a VAI or 483 observations. Our new facility in China, which has capabilities in manufacturing Respules for local markets as well as the US, also cleared the US FDA audit with 483 observations. We expect to start supplies of the Respules to US from China a strong amount in the second half of FY 25.
Meanwhile, our Goa Unit 5 unit cleared audit by the MHRA, UK, earlier this year. Recently, two of our facilities, the Patalganga and Kurkumbh, also underwent the US FDA audit. The Patalganga facility was issued with six 483 observations, and the Kurkumbh audit ended with one observation. We await the official classification for both sites. In Goa, we have now finished the remediation activities and are ready for the US FDA audit. While at Indore, we are focusing on getting the plant remediated. I would now like to invite Ashish Adukia to present the financial and operational performance.
Thank you. Thank you, Umang. I would like to now present key financial highlights for the quarter and financial year 2024. To clarify, the numbers are adjusted for QCI disinvestment, which was completed earlier this year. We are pleased to report a quarterly revenue of INR 6,163 crore, with a healthy YOY growth of 10%, driven by our focus markets. As a result of this quarter, we ended the year at INR 25,455 crore, with revenue growing 14% YOY. The EBITDA margin for the quarter stood at 21.4% versus last year of 20.45%, almost one hundred basis points improvement.
For the year, the EBITDA margin was 24.5% as against last year of 22.2%, again, a 230 basis points beat. Gross margin after material costs stood at 66.7% for the quarter, which is 192 basis points over last year. The gross margin for the year is at 66%, higher by 200 basis points YOY. Expansion and profitability is largely due to favorable mix, calibrated price actions across branded and generic portfolio, and impact of easing cost inflation. Total expenses for the quarter include employee costs and other expenses, which stood at INR 2,797 crore, higher by 6.7% on sequential basis. Annually, the expenses were INR 10,572 crore, higher by 13% YOY.
R&D investments for the quarter are at INR 444 crore or 7.2% of revenue against our yearly average of 6%-7%, driven by product filing costs and developmental efforts, higher in the quarter by 19% versus last year. Overall, for the year, the R&D investments stood at INR 1,571 crore, or at 6.2% of the revenue. Profit after tax for the quarter is at INR 939 crore, at 15% of sales, ETR at 25.8%. Full year profit after tax stands at INR 4,106 crore, at 16% of sales and ETR at 27.1%.
Our capital investments for the year were INR 1,315 crore, out of which 70% was invested towards growth and improving our capacities and capabilities, while the balance was deployed towards maintenance and sustainability. Free cash generation and operating efficiencies has resulted in a healthy cash position. As at the end of the year, the gross debt on our balance sheet is INR 559 crore, which also constitutes the lease liabilities and working capital facilities. Cash equivalent balance as on the date stands at INR 8,267 crore. Looking forward, our key focus areas for FY 2025 will be growth for one India led by RX, where our aspiration continues to grow higher than IPM, backed by chronic portfolio. Efforts in trade generics will be channelized towards smooth transitioning to the new operating model for long-term benefit.
This may have an impact for a quarter, but over the year, we hope to recover. Cipla Health should be back on its growth trajectory after a difficult year impacted by seasonally soft demand. In North America, the aspiration will be to grow our top line YOY, primarily backed by commercial execution of existing portfolio and new launches. We remain focused on resolution of US FDA observations, de-risking our product launches. We would continue to explore inorganic partnerships and acquisitions. Growth in South Africa, supported by private and select tender business with priority on margin improvement. In EMEU, the top priority is to improve top line, while margins are maintained at a sustainable level. ROIC continues to be very healthy at around 31% for the last year.
We aim to deploy INR 1,500 crore in capex investments to enhance our manufacturing capability and improve sustainability. EBITDA margin for the full year is expected to be up to 100 basis points over last year, which should result in the range of about 24.5%-25.5% EBITDA margin. I'd like to thank you for your attention and would request the moderator to open for 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 their touchtone phone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Yeah. Hi, thanks for taking my question. Just can you explain the dynamics in the trade generic segment? You talked about some restructuring on the channel. What exactly is that, and, you know, what's the impact, you know, you expect in the first quarter there? And secondly, you know, what's the total contribution to the One India number from the trade generics? And, you know, given that many players are focusing on that in this segment, what's the... If you can comment on the dynamics evolving here? Thanks.
Sure. See, on trade generic, okay, on the model change that we're talking about is that we used to earlier have a sole CFA agent, and, you know, which used to earn the commission, and they used to handle the collections as well as inventory, et cetera. And now what we have done is that that converts into only a marketing agent, okay? So it will only be a commission, and we'll directly deal with the stockists underlying that sole agent. So we will have direct connect with the stockists now. Now, this requires a little bit of administrative changes, et cetera, due to which there can be some hiccups in the first quarter as we transition with the direct connect.
But over a period of time, like I said, it will ease out to normal growth.
Uh, yeah.
You know, on the second question, you know, the split, we usually, we don't give that split. It's the same split as both halves grown, trade generic slightly higher than the RX market. So the split is broadly same as has been in the previous years.
Yeah. Maybe I can add, Ashish, just a couple of points. So, Saion, the attempt is to move closer to the you know, to trade in generic. We'd like to actually consolidate distribution across our RX and GX, and we think that by, you know, us taking the operation over, we will be able to move closer to trade. And that's the change that's happening in GX. I think if your question is, how much is it going to be an issue in a quarter? Not significant enough for us to get concerned right now. I mean, there might be some impact as inventories get reshaped, but not significant for us to be worried at all.
I think on your next question, just very quickly on the, you know, the generics business is also a branded business. We have to fundamentally understand this. Medicines don't sell as the generics, as GX, GX. They sell as still branded GX. And I think the dynamics of that business are still highly dependent on the brands you sell. So as long as there's brand saliency, competition may impact you, but, you know, our thesis of big brands going bigger continues to shape the trajectory of that business.
Okay. Thank you. Thanks.
... The next question is from the line of Kunal Randeria from Axis Capital. Please go ahead.
Hi, good afternoon, sir. So my first question is on your inorganic investments. So while you've kept the door open and you want to be judicious about it, a few years back, you had made some forays in semi-specialty products like IV Tramadol, Pulmazole. So while I understand it didn't work out, are you still keeping your options open? And if so, perhaps you would like to maybe tell us which kind of assets you would be interested in and the amount that you would be comfortable investing?
Ashish bhai, maybe you can answer that.
Yeah, sure. See, I think, you know, with India, we are fairly comfortable with the growth et cetera, that is available in the market. So we can, we can make a large acquisition in India to make sure that in the white spaces, the therapies, et cetera, which is our focus areas, where we're not a leadership position, we will go ahead and we can make large acquisitions out there. When it comes to U.S., portfolio or partnership or in-licensing products, et cetera, there, I think, it won't be a large acquisition, and it will be a lot focused on products where there is some differentiation available, either, you know, it could be supply constraint or lower competition due to many reasons.
I would be interested in such opportunities out there so that it has a longer life in the market. Kunal, Kunal, if you want to add, please, please go ahead, yeah.
No, I think what you've covered is great. I think that's very elaborate. Thank you.
Sure. Thanks. And my second question, see, with so many players coming in trade generics in India, how do you see this market shaping up? Because at some point it will cannibalize, it has already started to cannibalize the branded market for the industry. So just your thoughts on how the market will shape up in the next 2 to 3 years.
Actually, you know, I have a different view on this, and let me answer it. We don't see more than a 20% overlap between what sells in the Tier 2 to 6 cities in our generics business versus what sells in these cities from our RX or prescription business. There is very little of the prescription business that filters down to Tier 3 to 6 towns.
You know, and therefore, we believe that the generic business, as penetration of healthcare deepens, is only going to expand in volumes. It's not going to decrease. Having said that, and I, as I mentioned earlier to Simon, the business is still a branded business, and the real, the salience and relevance of brands is very important. So the older the brand, and the more current the therapy, the business will continue to grow. And over the last two years or three years, we have been diversifying ourselves away from a pure chronic orientation, in this part of the business. So we feel, you know, competition is good. It will drive, definitely growth higher, but we don't see this business as cannibalizing the branded business in any way, the branded prescription business in any way. That's number one.
Number 2, we think the market is big enough to drive further penetration through the competition activities. And 3, businesses which have been historically present and have large branded franchises, because that's essentially what the generic business is, are actually on a firmer ground compared to some of the newer entries.
We got it. Okay, thanks for answering my question and all the best.
Thank you.
Thank you. The next question is from the line of Nitesh Dutt from Burman Capital . Please go ahead.
Hi, thanks for the opportunity. So I have a question on the manufacturing strategy of our India business, both the prescription and trade generic side. So what percentage of the manufacturing is currently being done in-house, and what percentage is outsourced? And will you be maintaining the same mix going forward? And second, I also want to understand if the, for the outsourced portion, is that, fragmented across a lot of, suppliers or consolidated amongst a few top players?
So I'll try and give you an answer. I think we have a larger share of the prescription business manufactured in Cipla facilities than the generic business. I think we have strategic partnerships with a lot of people who some of whom consolidate with us, and typically it's easier to consolidate manufacturing in OSDs than it is in injectable facilities, than it is in dermatological facilities. So I think we have a strategy of consolidating facilities here, but in-house facilities supply a much larger share of our prescription business and than the generic business. But in-house facilities supply both businesses as of today.
Is it possible to give any number on what percentage might be getting outsourced and what is getting manufactured in-house?
So I can give that to you. The only issue is that it varies quarter by quarter. And the reason for that is that it's seasonal. So when we see a huge amount of the respiratory season, most of that comes from in-house. When we see a season which is more, you know, chronic, heavy, again, a large portion of that comes from in-house. So I think it's difficult to give you a picture other than just perhaps say that a large share of our, a larger share of our prescription business comes from in-house than the generics.
Understood. And so finally, the government has been placing a lot of emphasis on cracking down upon some of the smaller CMOs, et cetera, and focusing on stricter implementation of Schedule M norms , et cetera. So, can it impact our procurement strategy or contract manufacturing in any way?
Yeah, I think-
Consolidation or increasing the procurement cost.
No, it's a great, it's a great question. I think by and large, the industry, and the IPA is moving to facilities that have, as a minimum, WHO approvals. So that's the first step that's started happening. So if there's a facility that at least has a WHO approval, it's gonna be preferred. If it's got an approval which is, you know, WHO, plus Europe, plus something else, then obviously that's gold standard. You know, it starts getting closer to gold standard. So that's one, that most companies are now looking at. And this will hopefully push the standard of manufacturing in the Indian diaspora.
The second is a more heightened oversight of quality, including release tests, et cetera, at these facilities, where most companies are now adding a lot of requirements, and more spontaneous quality checks, including audits by, you know, including unannounced audits by the respective companies. So I think these are the two models that perhaps are immediately impacting the industry, but I think that I'll leave it at that.
Sure. Thanks a lot for this. I'll come back in touch.
Thank you. The next question is from the line of Kanha Agarwal, who's an individual investor. Please go ahead.
Sir, why is there an increase in the other expenses for the quarter versus Q3?
I'll request Ashish or Aditya to answer.
Yeah. No, thank you, Umang Vohra . That has manufacturing cost, that has S&P, that has even CSR sitting out there. So it has many items out there. So, you know, R&D also is sitting there, so there's increase in R&D because of one of the filings also that we have made. So it's due to these combination of reasons that we have a increase in the cost out there.
This should substitute, so subside in the next quarter?
Yes, absolutely. It will, so quarter-over-quarter, this can change, but if you look at the entire year, it is going to be in line with the sales growth, and we maintain the percentage that discipline is maintained.
Okay, sir. Thank you for answering my questions.
Thank you.
Thank you. The next question is from the line of Damayanti Kerai from HSBC Securities and Capital Markets India Private Limited. Please go ahead.
Hi, thank you for the opportunity. My first question is, you mentioned in your presentation 12 assets were filed in peptides and complex generics, which would likely see launch during 2025-2027. So just want some more color on, like, the market opportunity for some of these critical assets, and whether these will be manufactured in-house or you'll be getting it done through CMO?
Yeah. So peptides, all of our peptides is manufactured by our third-party partners. And on market opportunities, there are, you know, some of them that can be large opportunities, like in case of our current portfolio. You know, but there's a long tail as well.
Okay. So mix of some significant assets plus smaller assets here. Okay. And just coming back to U.S., so with $900 million base now, you mentioned like you'll sustain growth, but whether for that new launches like your Abraxane, et cetera, should come in, or you believe current portfolio has significant headroom to sustain growth from this $900 million base, even for FY 2025?
Sure. I think the... Go ahead, Ashish. Go ahead.
Please go ahead.
Okay. So, yeah, I think we think the current portfolio has opportunity within the set of products, because as we mentioned, we think Albuterol can be slightly higher in share. We think that lanreotide can still increase its share. And so I think there is a fair amount we can build out of the current portfolio, but also from new launches. I think you know the step function jumps in growth will come more from new launches. So we will have a very normalized growth rate from existing portfolio, but the new launches will add the step functions to it. So both, the answer would be both.
... Okay, that's helpful. And my final question is, any update on Goa plant from FDA side, when they would likely come, and do you still expect Abraxane to potentially see launch in this fiscal year?
So the timing of Abraxane is gonna depend on the Goa inspection. We earliest, Goa is the earliest path for a launch. I think, so if it can happen early part of the year, there's a good chance for Abraxane to be in the later part of the year, maybe not. So it's all linked to the Goa inspection. We think the Goa inspection, from our last, from our last inspection, we will be completing roughly about two years in July, August of this time frame. So that would, you know, around that time or beyond it, is probably the time to expect the reinspection.
Okay. So most likely in first half of this fiscal, if again they visit the unit, then there's a good chance Abraxane will come this fiscal.
Yes, I mean, I would say that, but I think we, you know, please keep in mind an inspection needs to happen, then there is a 90-day process, post-inspection for a company to respond, and then the EIR comes, and then the asset has to be approved.
Right.
Just factor that timeline. It's very sensitive to when the plant is ready.
Okay. Thank you for your response, and all the best.
Thank you very much.
Thank you. The next question is from the line of Surya Patra from PhillipCapital India Private Limited . Please go ahead.
Yeah. Thanks for this opportunity, sir. My first question is about the potential business opportunities in the specialty areas. See, earlier, we have already talked about biosimilar alliance and spending towards CAR-T kind of therapies, mRNA. So is there any update on that side, or are we seeing any kind of meaningful progress on those front as a growth driver for our future business?
I'm happy to answer on that, and Ashish can add. So we are beginning to see to make choices on capital allocation in that side. And it's not so much with the perspective of the next one to two years, but really the transition of medicine that's happening there, biological sciences are perhaps becoming more and more relevant in the field of pharmaceuticals. So, you know, we are now in the process of setting up an mRNA lab in Germany. That process has started. We've recruited a few members of the team. Biosimilar asset is now hopefully going to enter phase one soon, which is, you know, which is an asset that is most likely to launch around the 2030 timeframe. And that's one asset that we're working on, and there are a few others.
On CAR-T, we are evaluating the, you know, what we can do in that space as well. So this whole area, along with our investment in Stempeutics, is the new area of science which will become relevant 5, 7 years later in the area of medicine. I think, we want Cipla to have a chance to be able to play a formidable role, just like it does in the chemistry side of the world, but also to play that role in the biology side of the world.
Okay. Yeah. Thank you, sir. My second question is on the, let's say, since it is the fourth quarter full year call that we are discussing, so can you give some sense, respiratory as a portfolio, what would be its revenue share, let's say, for US and for your global business? And since our developmental pipeline is also focused around it, so let's say over the next 3-5-year period, what is the revenue mix that you would like to have from this respiratory portfolio?
The overall, if you look at our respiratory across global revenue, it should be somewhere around circa 30%. That's the kind of share that we have. And in the US, it's the Respules, it's Albuterol, these are the key products that we have, Salbutamol. These are the key products that we have in respiratory. And then, of course, we talked about Symbicort and Qvar and some of the other products also that we are working on. So respiratory is certainly our... We are leaders out there, and the whole idea is to retain and grow that leadership in all the markets where we are selling these products.
Okay. So just an update, or a clarification, rather. In terms of the Lanreotide, see, we have certainly seen a kind of steady progression, but, is there any risk that one should think about the pricing situation, or, is there any risk to the current pricing that you are having for Lanreotide?
So it's a two-player, broadly a two-player market.
Right.
As we see it. So, you know, depending on the other player, the prices may vary. But we look at it as a total value that we, we have, and the whole idea is to actually grow that value this year.
Okay. On your permission, sir, just one clarification. So what is the update on the inhalation line that you are trying to set up in U.S., whether it has been set up already?
Yeah, no, no, that's under way. So, like, this was part of our de-risking plan to actually set up these lines in our Indian facility. So basically, our Indian facilities that we have across two locations. And one of them will be more focused on inhalation, the inhalers assets that we have, which we are filing for the approvals. This is part of the de-risking. It's very much on track, as we speak.
Sure, sir.
Yeah. Ashish, can I, can I maybe just clarify a little bit more on that? So two lines as Ashish mentioned. The first is a line for MDI, where we have already taken red batches for several items, right? And the line has been, you know, the line has been approved by the FDA, and it's... The plant has gone through an audit, possibly two times already. The second is a new facility for DPI, which is coming up and where the equipment qualification is happening now. Feasibility batches are being taken. That's for the DPI.
Yeah. Sure, sir. Thank you. Wish you all the best.
Thank you.
Thank you. The next question is from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
Yeah, thanks for the opportunity. Firstly, also, there has been some news about the GST relief coming through. Any thoughts on this?
No, we've not got any specific GST incentive circular relevant to us.
Okay. Secondly, sir, just to know how much investment you would have done for the facility in China?
Oh, about $40 million-$50 million, somewhere around that zip code. And it's-
I understand.
Got its approval now, and, both for the facility as well as for the product. US-
Sorry. How many more products do you intend to file or awaiting approval from this side, if you give some more color?
Sorry, your voice?
Let me take that.
How many-
I'll take it. I think what he's asking is how many products we expect to file from the facility. I think this facility is only a Respule facility. So our strategy is to, you know, there are fewer Respule products than many other OSD products. We will file Respule products, which are basically steroids, but we would also be filing products where we're taking the same product to multiple geographies where we can service the demand.
I understand. So given that the cash continues to build up the balance sheet, and while the investment, let's say, in the new areas, such as biosimilars is relatively smaller, is there any thoughts or strategy in terms of adding new geographies per se, apart from India, North America, South Africa?
No, so we don't have any. We already operate in many countries, so we don't have any strategy to add a new geography. We will look at some of our key markets, global markets and international, where we want to go deeper. And, and, and definitely, China would also feature in that. Now, we have a facility there. We're looking at growing that geography for ourselves more than what we are today. Other than that, there is no really active strategy to look at more geographies. In terms of your question around capital allocation, we have stepped up the dividend by, you know, from INR 8.5 per share to almost INR 13 per share.
Beyond that as well, I think the whole idea is to focus on some large growth opportunities, not just smaller investments, but large M&A growth opportunities that we have. We have, we are actively looking at many growth opportunities, which should consume some of the capital that we have.
Understood. So just lastly, from a capital allocation point of view, over, let's say, next 2-3 years, how much do you intend to invest in your biosimilars portfolio, product development, as well as, let's say, building the manufacturing capability?
See, it's difficult to give out those numbers. We have already indicated that currently we're working on one global biosimilar asset. We have plans to add more. And as you may know, how much it takes to, you know, per asset in terms of development. So we—you know, it's difficult to give a number to it, but we always look at the new horizon growth to be core part of our strategy, which includes biosimilar, specialty, CAR-T, and what Umang had talked about, shift from chemistry to biology.
Understood, sir. Thank you.
Thank you. The next question is from the line of Amey from JM Financial. Please go ahead.
Yeah, thank you for taking my question, and congratulations on a good set of numbers. I have first question on the EBITDA guidance, which was given in the opening remarks, around 24.5%-25.5%. Does the guidance include the higher sales of Revlimid in FY 2025 over FY 2024? And the second question is on the Sanofi tie-up, which we have done for CNS products. If we can give more color on this tie-up, are these products complementary to our portfolio? And also, what is the contract structure for these kind of products? Thank you.
So, so see, this is an overall EBITDA guidance that we're giving of 24.5%-25.5% across all markets. And, on your second question on Sanofi CNS portfolio, you know, that's something that, you know, as per IQVIA, it's about INR 250 crore of sales for us. And the whole idea, what we've been mentioning, that therapies which we have identified as our focus therapies, we would like to increase our share because that helps us in a longer term to not just gain share, but have better growth as well.
Will these contracts will be like royalty driven or you will be getting markup or, like, how would be the profitability for these kind of contracts?
Sorry. So, I have one correction.
Let me take that. Ashish, let me take that question, but complete your... Yeah, complete your point.
I said INR 250 crores, INR 150 crore IQVIA math. Go ahead, Umang, sorry.
Yeah. No, so these will be very typical to licensing arrangements that we have on other products. There's going to be not much difference in the terms here versus the other. But I think what it adds a strategic value to us is the ability to be present in a category of products where we believe that... You know, for example, we are very strong in epilepsy, and we aim to become stronger in neurology. And I think there are products like this which allow us to complete the offering in the CNS space.
Got it. But the Frisium is for epilepsy, right?
That's what I'm saying. So epilepsy, and neurology, that's where we want to be in the CNS space. So for example, within the CNS space, at this point, we don't have either the portfolio or the muscle power to be, to compete with others who have stronger portfolios in the psychiatry space, for example, right? Or even in the Parkinson's space. But our portfolio is more present and allows us to compete in the space of epilepsy, and possibly other conditions of neurology. So that's why this portfolio was important to us in those categories.
Got it. Just one more follow-up on the first answer on the overall guidance. The reason I'm asking, because the incremental sales, if you assume the 10% kind of a growth next year, from that kind of a margin, the incremental sales will be coming at around 30%+ EBITDA margin, 35%+ EBITDA margin. So it will need a good amount of sales from high-margin products. So that's why I was asking whether the Revlimid increase in sales be presumed in the guidance or no?
So we have certain cost measures also. There is overall, you know, focus on improvement of cost, as well as other costs as well, that we focus on to try and achieve the margin that we have guided to, towards.
Sure.
I think the answer will be yes. The answer will be yes. It, it is fairly comprehensive of what we think we can achieve, based on various factors that are coming. I think one of the things that we are also guiding towards is, is, sharper investment in India and the field force. We will be expanding our field force in India, and I think the numbers that we've indicated to you are the consummate, number of that.
Sure. Thank you so much. Thank you.
Thank you. The next question is from the line of Nitin Agarwal from Dam Capital. Please go ahead.
... the U.S. will have two more years of reasonable Revlimid contribution. You know, with whatever growth plans we have in place, I mean, how do you see a potential FY 2027 EBITDA? Do we have enough levers in the business to grow beyond whatever we do in 2025, 2026, and 2027, on top of that?
...Yeah, maybe I could go first, and then Ashish can comment. Look, I think, you know, while we have limited in our numbers today, we are also constrained by the inability to launch several products from our facilities due to their citation. And some of these products are fairly, you know, can be fairly material to the trajectory of this of our company. So I think that's the first thing that we should just keep in mind that as some of these facilities become citation-free, there will be an opportunity to launch those portfolios.
The second, as Ashish mentioned, we're also preparing for a post Revlimid scenario, which is not just pipeline and portfolio, but also a fair and significant amount of effort for the organization on the cost front, and that exercise has started. The third aspect is we continue to see robust growth in India, and a large portion of that growth hopefully will stay and continue to stay profitable, as we expand into the interiors. So we are seeing growth coming from there. We are seeing growth coming from our emerging markets and new franchise, which has historically been flat. And we see a pipeline that will support the, you know, the Revlimid going away, some of which is pending just inspections, some of which is actively under review, along with our cost program.
That's how we look at our business proposition.
Thanks. And just an analyst, you mentioned about, I think in the previous call, a large-ish launch coming through in Q1 on a peptide. I mean, are those plans still on track for that launch?
Yes, they are.
Okay. And secondly, last one. You did mention a little bit in your comment about emerging markets in Europe. I mean, relative to peers, I mean, this has been a relatively underperforming segment for us. How do you see... You know, is there anything that we are looking to do to incrementally move up the momentum here? And where do you see these two segments really moving forward?
So, you know, the problem with emerging markets over the past three to four years has been surplus presence in a lot of geographies which got impacted by the, you know, by the economic environment in the world. Where we are today is that we believe most of these have bottomed out. And, you know, we see that this is a very good base to possibly show growth now, going forward. Also, our pipeline in Europe should hopefully unlock. We've been building that over the past two to three years. And so if you add those two together, while we are not guiding to say that the business is going to treble or double or... That's not where we are going, but I think we should hopefully be able to see a respectable double-digit growth in this segment.
Thank you.
Thank you. Ladies and gentlemen, we'll take the last two questions. The next question is from the line of Kunal Dhamesha from Macquarie Capital. Please go ahead.
Good evening, and thank you for the opportunity. So the first one on the revenue growth, have we put out, have I missed something as to what are expectations for in terms of revenue growth for financial point?
So we do not give revenue growth guidance, but certainly for our core markets of India, U.S., as well as South Africa, and then especially India and South Africa, because that's actively tracked and we are guiding towards that.
Okay. And, in terms of the, R&D expenses for the next year, how do you expect to trend? I think this year was 6.2%, next year-
Yeah, so it should be in the range of 6%-7%. We continue with that range.
6%-7%. Okay. And then, if I may, the last one on the, you know, when you say this 24.5-25.5, will it be contingent on Goa plant clearance with some margins improvement?
No, no, this is not contingent on Goa plant clearance.
That should provide an upside if it happens, right?
So yes, certainly there could be some up, but, but, you know, we, if-
It depends on the timing of the inspection, right? Completely. Because if the timing of the inspection is later in the year, we are unlikely to receive any impact out of this. If it's slightly earlier in the year, again, keep in mind the 90-day process, post inspection and then the file movement. Right? So you could actually say that after the audit, it will still take about, you know, 3-6 months for assets to start getting cleared. So it completely depends on the timing of the audit, but as of now, we assume that this only will come in the later half of the year. The asset progression will start only in the later half of the year.
Sure. So, the last one on the generic filing. So, you know, between Indore and the new line that you have put up in U.S., which in your view would be faster?
... And when are we putting that launch into our future frame?
So I think you know, we are hoping that the batches on the new site can happen, you know, can start, since we are already at the feasibility stage, and I think the timing will start from there.
Okay. And when are we putting it as a broad range of-
I'm sorry?
In terms of launches within the next year, where it will be, it will be in the third year, second year?
Well, I think we have a good shot at launching it towards the end of this year, for sure, for sure. Fiscal year, for sure. I think that we have a good confidence of doing, but depends on the line.
Okay. Thank you, and all the best.
Thank you.
Thank you. The last question is from the line of Alankar Garude from Kotak Institutional Equities. Please go ahead.
Hi, thank you for the opportunity. Sir, when you talk about increasing share in Albuterol and Lanreotide in FY 25, are you factoring in incremental competition in both these products?
Yes. Like, whatever new players are likely to come in, we are cognizant of that, and, with that, we are aiming to increase our market share.
In both these products, right?
Yeah. So Albuterol, we've already in April seen some growth like we've suggested. From 12%-13%, we are at about 15%, and we see that trend of going up continuing.
No, I meant, I mean in terms of facing incremental competition, that can be expected in both the products, right?
Yes, albuterol has got all your competition already in the market. So, we don't have any incremental competition there.
Understood. Understood. And, maybe a second question there, Ashish, I mean, linked to the inhalation portfolio. Now, with innovators lowering prices for out-of-pocket patients starting June, is there a risk to generic pricing in both Albuterol and maybe Advair later on? And conversely, I mean, if there is a possibility of lower rebates, can that actually lead to higher generic share for some of these inhalers?
So in case of Advair, we've already seen the market over a period of time to have come down the price. So I don't think it will go down further. And Uma, you may add if you have any perspective.
No, actually, the other trend may start. If the rebating is lower, then actually the generic share would go up. So we... It could go either way. It's not necessarily that, you know, the generic is today in a category like Advair, still only 50% or 60% of the market with two or three players already, right? So I, we think there is volume play there. On Albuterol, really, I'm not sure we are looking at significantly increased competition, at least in the category that we are playing in.
Thank you. That's helpful. Maybe one last question, with your permission. So you have been speaking about pursuing in-licensing opportunities within GLP-1 in India. Now, considering that, there would be many more companies interested in such tie-ups, what would be Cipla's USPs here? I mean, in your pitch to these innovators, what would be the points for you to highlight?
So we have you know excellent in-licensing partnerships already established and built over a period of time, and that relationship will definitely give us hopefully an edge over others. And we are a large player in the country. And at the same time, we are evaluating from our side all possible options, our own partnerships, et cetera, because it's a large opportunity overall that we would like to play in India.
Understood. That's all from my side. Thank you.
Thank you. Ladies and gentlemen, we would take that as a last question. I would now like to turn the conference over to Mr. Ajinkya Pandharkar for closing comments.
Thank you, Sagar. I thank you all for joining this call. If you have any further queries or questions, please reach out to investorrelations@cipla.com. I wish you all a very happy weekend.