Zydus Lifesciences Limited (NSE:ZYDUSLIFE)
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May 4, 2026, 3:30 PM IST
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Q3 23/24

Feb 9, 2024

Operator

Welcome to Zydus Lifesciences Limited Q3/FY24 Earnings Conference Call. Please note that all participant lines will be in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks. Please note that this conference is being recorded. I now hand the conference over to Mr. Ganesh Nayak, Executive Director of Zydus Lifesciences. Thank you, and over to you, sir.

Ganesh Nayak
Executive Director, Zydus Lifesciences

Good afternoon, ladies and gentlemen. Welcome to our post-results teleconference for the quarter-ended December 31, 2023. For today's call, we have with us Dr. Sharvil Patel, Managing Director, Mr. Nitin Parekh, Chief Financial Officer, Mr. Arvind Bothra, Senior Vice President, Investor Relations, and Mr. Alok Garg, Senior Vice President from the Managing Director's Office. Let me now give you a broad overview of the developments during the quarter. We are happy to end the calendar year with a strong performance and expect to sustain the growth momentum going ahead. The quarter gone by was an encouraging one for our India formulations business. The business delivered strong double-digit growth during the quarter on the back of healthy volume growth and new product launches.

In the consumer wellness space, our category-leading brands like Glucon-D, Everyuth Scrub and Peel Off, and Nycil gained market share during the quarter despite the challenging demand scenario. Our US-based business registered improvement in profitability driven by sustained volume expansion and new product introductions made over the last 12 months. On the emerging markets and Europe formulations front, robust growth momentum built over the last several quarters sustained with the business delivering healthy double-digit growth for yet another quarter. With that, let me take you through the financial numbers for the quarter gone by. We registered consolidated revenues of INR 45.1 billion, up 6% on a year-on-year basis. For the first nine months of the current fiscal, the growth was 15% driven by healthy double-digit growth registered in all our key markets. EBITDA for the quarter was INR 11 billion, with a growth of 15% on a year-on-year basis.

EBITDA margin for the quarter stood at 24.5%, which is an improvement of 200 basis points on a year-on-year basis. The business delivered robust operating performance during the current fiscal as the EBITDA margin for the first nine months of FY24 was 26.8%, up 550 basis points over the corresponding period of the previous financial year. Net profit for the quarter stood at INR 7.9 billion, up 27% year-on-year. Our balance sheet continued to strengthen with a net cash position of INR 15.2 billion as at 31 December 2023, against the net cash of INR 5.5 billion as at 31 March 2023. Now, let me take you through the operating highlights for the third quarter of FY24. Our India geography, which comprises the formulations and consumer wellness business, accounted for 42% of the total revenues during the quarter and grew 11% year-on-year.

As mentioned earlier, our formulations business in India delivered a strong double-digit growth during the quarter with a growth of 16% year-on-year. The branded portfolio grew faster with a growth of 17% year-on-year. Portfolio of key pillar brands and innovation products registered strong volume growth, driving overall growth during the quarter. During the quarter, we gained ranking in the cardiac and anti-infective therapies and registered improvement in market share in the antidiabetic and anti-infective therapies. On the specialty front, we retained leadership position in the nephrology segment, while in the oncology space, we remained the fastest growing company in the IPM. As per IQVIA MAT December 2023, our chronic portfolio grew faster than the market with a growth of 12% against the IPM growth of 11%. Our share of chronic portfolio has gone up by 136 basis points in CY23 to 41%.

Consumer wellness business recorded revenues of INR 4 billion, down 3% on a year-on-year basis. The sector continues to witness subdued demand similar to the previous quarter as the expected buoyancy in rural demand continues to lag. The personal care segment, which comprises Nycil and Everyuth brands, registered yet another quarter of strong growth. Gross margins continued its upward journey with an improvement both on a sequential and year-on-year basis. Now, let me take you through the performance of our US formulations business.

The base business displayed robust momentum during the quarter with sustained volume expansion on a sequential basis, well supported by new product launches, including some differentiated launches which helped profitability improvement. Overall, the business posted revenues of INR 18.4 billion during the quarter. We launched 11 new products during the quarter. New launches for the quarter include launch of our first 505(b)(2) product, Zituvio, and two transdermal products.

We filed 12 additional ANDAs and received final approval for 6 ANDAs during the quarter. As mentioned during the last earnings call, we also received final approval for 2 ANDAs, namely sitagliptin tablets, which is Zituvio, and sitagliptin and metformin IR tablets, which is Zituvimet during this quarter. On the international markets front, which comprises emerging markets and Europe formulations business, all major markets of Asia-Pacific region and Africa registered robust double-digit growth during the quarter. Demand scenario remained strong in Europe, while in Mexico, the business continued to grow in double digits. Overall, the business posted revenues of INR 4.9 billion, up 31% year-on-year. On the operations front, we have built a network of regulatory compliant manufacturing facilities and a resilient supply chain which serves as the backbone of our business globally.

We remain committed to extend our robust compliance record by maintaining the highest standards of quality and, in turn, ensure uninterrupted supply to our customers across the globe. This concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers across businesses as well as initiatives in our innovation program.

Sharvil Patel
Managing Director, Zydus Lifesciences

Thank you, Mr. Nayak. Good afternoon, ladies and gentlemen. It is a pleasure to have you all here on the call today. Our performance during the current fiscal has been very encouraging so far, and we are confident of meeting and possibly exceeding our growth aspirations for the year. All our key markets delivered healthy growth with significant improvement in profitability. We remain committed to expand our presence across markets through expansion of our offerings to satisfy diverse healthcare needs of patients and, in turn, generate greater value for all the stakeholders. On the India formulations front, our endeavor is to strengthen the position across focused therapies through multiple levers. We continue to work towards expanding our geographical reach, leverage multiple distribution channels, exploring different partnership opportunities, launching new products, and leveraging our innovation portfolio to offer novel solutions to the patients.

We have been conducting various patient support programs and activities to create greater awareness among patients, particularly in the areas of their unmet healthcare needs. On the U.S. formulations business, it continued to exhibit resilience on the back of volume expansion in base portfolio and new launches. Comprehensive portfolio of generics and proprietary products developed in-house as well as through partnerships. Strong customer relationships, a network of regulatory compliant manufacturing facilities, and an agile supply chain will ensure sustained growth for our U.S. business going forward. We have a strategic focus to scale up our operations in the U.K., which is part of our international markets business. We will leverage our global R&D portfolio of differentiated and niche generics as well as specialty products and build a strong growth path for the U.K. market going ahead. Integration of LiqMeds following the transaction completion during the quarter remains on track.

We are excited about the potential of differentiated pipeline of liquid orals of LiqMeds. U.S. and U.K. are the key markets for us for the portfolio of oral liquids. Going forward, we shall expand our offerings of liquid orals to other countries of the international markets as well. Our innovation pipeline across different areas continues to flourish, which is evident from the achievement of the different milestones. Our innovation engine has enabled affordable treatment options that are made accessible to the patients and, in turn, have delivered strong volume growth consistently for the company. With this, let me talk about some material developments on our innovation efforts during the quarter. On the NCE research front, during the quarter, we expect to complete the patient recruitment for our Phase IIb/III clinical trials of saroglitazide magnesium for the PBC indication for the U.S. market.

We also completed the hepatic impairment study of the molecule in cirrhotic cholestatic patients and published the results of the same in CPDD. The phase IIb clinical trials of saroglitazide magnesium for NASH indication for the US market are also progressing as per plan. We have received permission from the US FDA to initiate phase II clinical trial of ZYIL-1, an NLRP3 inhibitor, in patients with Parkinson's disease. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the molecule in patients with Parkinson's disease. The US FDA has granted an orphan drug designation to the molecule to treat patients with CAPS, a rare autoinflammatory disease. ZYIL-1 is also undergoing a phase II clinical trial in India in patients with amyotrophic lateral sclerosis, the disease called ALS.

ALS is a rare, progressive, and fatal neurodegenerative disease with an average life expectancy of three to five years from the time of symptom onset. We completed the phase II clinical trial of ZY19489, a potential single-dose antimalarial drug, and submitted the protocol to DCGI to initiate the phase III clinical trials. In the biotech R&D space, a pipeline of biological products continues to advance further, with two monoclonal antibodies awaiting marketing approvals in India. Two other products, including RabiMabs, are undergoing a phase III clinical trial in India. On the specialty and the 505(b)(2) development front, we completed asset transfer of CUTX-101, a copper histidinate product candidate for the treatment of Menkes disease from Cyprium Therapeutics. Under the agreement, we received worldwide proprietary rights and the US FDA documents pertaining to CUTX-101.

The rolling NDA submission of CUTX-101 is going on at present, which is expected to be over during the current calendar year. Thank you. Now we can start the Q&A session. Over to the coordinator for the Q&A.

Operator

Thank you very much. We will now begin the question-and-answer session. Anyone who wishes to ask questions may raise your hand from the participant tab on your screen. The participants are requested to use headphones or earphones while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from Neha Manpuria.

Neha Manpuria
Director, Bank of America Securities

Yeah. Thanks for taking my question. My first question is on the India growth that we have seen in the quarter. I know you've talked about India starting to see double-digit growth over time. But was there anything specific in the quarter? How sustainable is this trend as we look at the next year? So that's the first part of the question on India. And second is also, to maintain this growth momentum, do we think we need to add MRs or continue to invest in the India business to support this double-digit growth?

Sharvil Patel
Managing Director, Zydus Lifesciences

So as I said, the continued effort, persistent effort on India business for our key molecules and therapies continues. So there is no one-off in this. It's all driven by volume growth and new product launches, which has led to this growth. And we do believe we will continue to look at expansion in terms of number of reps in the India market, which we have started to do. And I think the full effect of it, you'll get to see from quarter one of the next financial year.

Neha Manpuria
Director, Bank of America Securities

How many reps are we adding, sir? What's our current strength, and how much are we adding?

Sharvil Patel
Managing Director, Zydus Lifesciences

We will be adding around 700.

Neha Manpuria
Director, Bank of America Securities

Got it. Are these in specific therapy areas, market penetration? What's the thought process when we are looking at this rep addition?

Sharvil Patel
Managing Director, Zydus Lifesciences

So yeah, it's a mixture of both, both reach as well as because of a larger portfolio, better coverage of the portfolio.

Neha Manpuria
Director, Bank of America Securities

Understood. My second question is on the LiqMeds acquisition that we announced last quarter. How should I think about monetization of the portfolio as we go ahead? I think from what you'd announced, they have a facility in the UK. So how should we think about this business contributing to the growth in the US, ROW, and therefore to earnings?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think on the earnings front, LiqMeds will start contributing immediately because it is a profitable business. And as I said, the business is currently based on 505(b)(2) products, which are both partnered and some of it in the future, which will be launched by Zydus also. And also, with our expansion in the UK and other markets using this portfolio, we would start seeing revenues much later. But its current business plan itself is very good for it to deliver its desired expectations that are there. And as I said, it will be profitable from this year onwards.

Neha Manpuria
Director, Bank of America Securities

What's the current revenue base, sir, from this business that we have?

Sharvil Patel
Managing Director, Zydus Lifesciences

It's right now very small. So it's just in the scale-up commercialization phase. So maybe in the next financial year, I can give you better input once we see it. But it is doing well right now.

Neha Manpuria
Director, Bank of America Securities

Got it. Thank you so much.

Operator

Thank you. The next question is from Kunal Dhamesha.

Kunal Dhamesha
Director, Macquarie

Hello? Can you hear me?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Kunal Dhamesha
Director, Macquarie

Yeah. Yeah. Thank you for the opportunity. So first, one on the US business, QOQ revenue seems to be flattish despite launching 11 products. So any particular product where we faced a lot of price erosion? Because I believe the overall price erosion remains benign in the market, right? So what has caused this? And I believe the Revlimid was also not a factor last quarter and probably not this quarter as well. So what has caused this revenue to remain flat?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think we are on track as per expectations for this quarter. This is the last quarter where distributors also look at their inventories and looking at restocking or destocking. So I think it is in line with what we expected. And quarter four onwards, we'll again see the uptick. But I think we are happy with the progress that we achieved, same numbers as last quarter. With respect to a lot of new launches in the last few months, you have to understand very little sales happen for new products in December. So we hardly get any few months to sell. So the more major impact will be in the next financial year.

Kunal Dhamesha
Director, Macquarie

Okay. Any comments on price erosion, what you have seen, what you are expecting for the next couple of quarters?

Sharvil Patel
Managing Director, Zydus Lifesciences

Always difficult to predict. I think on our base portfolio, we don't see any major price erosion. So it's negligible right now, but we cannot predict what will happen going forward.

Kunal Dhamesha
Director, Macquarie

Sure. Sure. Second one on the PBC trials that we are currently doing. So now that we are done with the patient enrollment, what is the internal estimate about when we reach the primary endpoint? Any timelines you would like to share there?

Sharvil Patel
Managing Director, Zydus Lifesciences

It's a 52-week follow-up. By next year, our expectation is by quarter four of FY2025, we would look for major data as well as submission.

Kunal Dhamesha
Director, Macquarie

There are no event-related data in this, right? It's just follow-up and measuring certain chemical?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yeah.

Kunal Dhamesha
Director, Macquarie

Okay. Okay. Perfect. And one for the India business on specialty, I believe we have set up a decent portfolio in India as well. Would you be able to help with what is the contribution of NCE products within our India formulation revenue for the nine months FY 2024?

Sharvil Patel
Managing Director, Zydus Lifesciences

So as I said, we are not giving individual product sales. But we have three NCEs that we commercialize. One is Lipaglin. Sorry, saroglitazide is under two brand names, Lipaglin and Bylepsa. We have our desidustat, which is Oxemia. We have our RabiMabs, which is a monoclonal antibody for treatment post-treatment of dog bite, which is just starting to commercialize. And some differentiated ADC, which are not proprietary, but which is Ujvira, which continues to do very well. But I definitely can say for all of the products, the growth is significant, and they're significantly scaling up. And we do believe that, first, Lipaglin will become the largest brand for the company very soon. And going forward, these are large opportunities for the company.

Kunal Dhamesha
Director, Macquarie

Perfect. Thank you, sir.

Operator

Thank you. The next question is from Bino.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Hi. Good afternoon. Hope you can hear me.

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Great. Just beginning with Revlimid, just to recap what you have said earlier. So the Revlimid will come back in four queues and then again be there in one queue. Is that the same pattern that will continue?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Okay. Second on this Zydus Lifesciences product, what's the early signs you're seeing in the market in terms of pickup? What's your strategy there? What sort of target market share you're looking at?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think this is going to be a slow scale-up. I don't think we will see significant traction immediately because we have to look at prescriptions for this molecule. We are currently with our initial discussions with both the PBMs, buyers, and others look interesting in terms of what we can do with this 505(b)(2). So I would think more color I can give after the first half of the year. But it will be a slow buildup. But I think as one of the important launches, for sure, this will be for FY25 an important value driver.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Okay. Does this product, mirabegron or Myrbetriq, one of your competitors, has kind of guided to a potential launch in Q1 FY25 depending on certain legal outcomes? What is your status there?

Sharvil Patel
Managing Director, Zydus Lifesciences

We have a final approval. We have an approval for this. I think it's a little too early to talk about it. At the appropriate time, we will do the proper disclosures on this.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Okay. Great. And last, the usual question on Asacol HD competition, any further updates?

Sharvil Patel
Managing Director, Zydus Lifesciences

No. We continue to enjoy exclusivity.

Bino Pathiparampil
Head of Research Analyst, Elara Capital

Great. Please keep it up. Thank you.

Operator

Thank you. The next question is from Surya Patra.

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Yeah. Thank you for this opportunity, sir. Congrats for the great set of numbers. My first question is on the gross margin front. While we know that the elevated gross margin number that we have seen in the recent quarters, it was obviously initially aided by the launch of Revlimid. But in the last two quarters, without Revlimid, we have been almost maintaining the similar kind of gross margin. So here, what is driving this? And it looks like that without Revlimid, if we are maintaining this, then subsequent quarter with Revlimid, we can see even improved number and whether this kind of run rate is sustainable.

Sharvil Patel
Managing Director, Zydus Lifesciences

So thank you for the good wishes and for the performance. But yes, I would say that the gross margins are driven by many ways. One is obviously the product mix, which is helping us in terms of the gross margin with the right focus both on the India business. And what one has to also see is that we have had important launches in the U.S. where the gross margins are better than obviously the average gross margin. So new products are helping in improving the gross margins. Also, I think scaling up of our other businesses is also leading to healthy improvements also with good launches in the international markets also. So I would say it's an overall improvement across the businesses on the gross margin front, which has led to this. And going forward, obviously, with Revlimid, we would see a higher uptick on gross margins.

But we do believe these are sustainable gross margins that we are showing.

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Okay. So just an extended one. Even for the current year, you have guided that EBITDA margin would be around 27%. So I think this is a kind of a great number that we are achieving after a gap. So given the kind of a potential annual volume ramp-up that you will see in Revlimid in the subsequent financial year and, again, product mix both in the U.S. as well as in the India market seeing a kind of improvement, so are you kind of guiding a more than 27% kind of margin run rate for next year?

Sharvil Patel
Managing Director, Zydus Lifesciences

I think it's a little early to talk about next year. But if we don't see competition on Asacol, we would obviously definitely continue comfortably and probably exceed because of the new launches.

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Okay. Okay. The next question is on the domestic formulation side. Say, in fact, obviously, we have outperformed the industry in this quarter and in the recent period. But going ahead, although you have also kind of indicated about the expansion force and all that, but see, practically about the chronic therapies performance going ahead, growth contribution coming from the innovative molecule, biosimilars, differentiated product offerings from your basket. So considering all that, what is the practical kind of progression that we want to expect from the domestic formulation business next year and going ahead?

Sharvil Patel
Managing Director, Zydus Lifesciences

Our intention is definitely to outperform the industry growth driven by many of the points that you raised both on the chronic as well as on the new portfolio and the proprietary medicines. That is our endeavor going forward. I think we are happy with the last few quarters' performance and especially the last quarter. We hope to continue to build this momentum into the coming quarters.

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Okay. Just last one, sir. Besides the US business, if you see, we have consistently been maintaining more than 200 kind of quarterly run rate. So going ahead, what is the kind of trend and what is the kind of this thing that we should anticipate? Because you have talked about multiple licensing product opportunities. We have seen some of the announcements relating to those in the recent months. But if you can just elaborate, meaning combining both these two points of the base business continuing the way it is and with the potential benefit flowing from the in-license product opportunities. So over the next 2-year period, what run rate that we can potentially achieve going ahead over this 2-year period, 2 years?

Sharvil Patel
Managing Director, Zydus Lifesciences

I think from the immediate point of view, I think, as you said, for this FY 2024, we will end the year with a good double-digit growth. Our endeavor is to continue to launch more products into the U.S. market. We do have almost every year one to two very large opportunities both by our own development and in-licensing. Until 2027, 2028, we have a very good pipeline of day-one launches and exclusive launches. We are quite excited about the kind of products that we hope to launch in the U.S., which could be revenue-wise sizable and profit-wise. But as you said, the U.S. is a moving parts business. There are a lot of things we have to achieve. Obviously, approvals. We have to achieve IP success and then obviously launch.

Hoping all of that goes through as we expect, we are seeing good progress on the U.S. business.

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Yeah. Thank you. Wish you all the best.

Operator

Thank you. The next question is from Sanath.

Speaker 8

Hello?

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Yes.

Speaker 8

Can you hear me?

Surya Patra
SVP Pharma & Healthcare Analyst, PhillipCapital

Yes.

Speaker 8

Okay. So first of all, congratulations for the good set of numbers. I have two questions. One is related to the consumer wellness business. So if the trajectory, there is no improvement quarter-over-quarter on this front, so what is going to be your strategy to improve the situation here? Secondly, which category - and I'm talking about not the drug - but which two categories in India and U.S. will propel your growth coming in the future from near to medium term?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think on the consumer side of the business, we have two portfolios. One is the skincare side, and the other is the food side. On the personal care side, we have done very well with a strong double-digit growth both for the year and the quarter. However, on the nutrition and food side, we have found it challenging with both the inflationary issues that have happened and, more importantly, rural demand not picking up, which is a normal trend that we have seen recently in the last two quarters in the market. Going forward, both from quarter four onwards and, more importantly, in the next financial year, we believe that with the normalized season, we would see better traction for our summer skewed products in the quarter four and quarter one.

With the important new launches, some distribution expansion, and also the line extensions that we are doing, we believe that we aspire to at least make sure we grow in double digits. Also, on the gross margin front, we have seen quarter-on-quarter improvement. Further improvement on the gross margins, we would see, which would help in terms of profitability. So I think it's still early days. We need to wait to see how do we do in the quarter four and quarter one. We have taken steps to make sure that we can find growth. We also need help in terms of the market growing for us to grow. The good thing for the wellness business is that in most of the brands, it has gained market share. In Complan, it has just managed to retain its market share.

Overall, in the difficult market also, the brands have continued to gain market share. That's in terms of relative performance. With specifics to the other question that you asked, so on the U.S. business, as I said, it's a mixture of all our portfolios of businesses of complex orals, injectables, and a whole portfolio that is aiding to the growth. I would say going forward, both complex launches in the oral side as well as injectable side will aid further growth in the U.S. market. Good compliance on manufacturing and supply chain is also helping us garner more business. We do continue to see a good amount of launches continuing over the next three years, which will help us sustain the U.S. growth. Of course, we still have to wait and see when we see Asacol competition.

But not seeing that, obviously, we have a much better trajectory right now. With respect to India, I think, as I said, multiple things. Focus on the pillar brands and chronic portfolio and the pillar brands driving penetration through better marketing practices. And also the new launches, day-one launches, as well as important areas like oncology and other areas scaling up will all lead to better growths. And obviously, our proprietary medicines have continued momentum, which is helping overall growth as well.

Speaker 8

So basically, in U.S. so when I said category, I meant whether it is going to be antivirals or antimalarial ones or.

Sharvil Patel
Managing Director, Zydus Lifesciences

U.S. is a generics business. It's not a branded business. So it's not a category-wise business.

Speaker 8

Okay. And India?

Sharvil Patel
Managing Director, Zydus Lifesciences

India, we are present in about six, seven important therapies, and we continue to pursue them.

Speaker 8

Okay. Thank you so much for your.

Sharvil Patel
Managing Director, Zydus Lifesciences

Thank you.

Operator

Thank you so much. Thank you. The next question is from Nitin Agarwal.

Speaker 9

Thanks for taking my question. Sharvil Patel, there has been a very strong growth in the emerging market business within the last three or four quarters. Anything particularly which has changed in this business, and what is the outlook for this segment as we go forward?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think, yes, the international business is we are very happy with both not only the revenue growth but also their improvements on profits and their thrust on improving profitability. So I think over the last five years, we have seen good growth in double-digit growth and also profitability improving. And with the pipeline of products and the focus on key geographies, we continue to see that. Also, I think going forward with the ability to leverage our complex dosage forms filed in the regulated markets, in many of the international markets, we will see a much better upside also. So I think we are very excited that in spite of geographical challenges, country challenges, and related to different issues, we still see a good momentum for the international business. And going forward also, it should continue.

Speaker 9

Which would be key markets in this emerging markets group?

Sharvil Patel
Managing Director, Zydus Lifesciences

So we have a Latin American focus, South Asia. We have Philippines, Sri Lanka, Myanmar, and also through partners, some other markets including Vietnam. And then in Africa, we have Uganda and South Africa, which are the critical markets. And now we also started to register products in Australia, also other markets in Europe, sorry, UK, France, Spain, and other markets. So I would say it's a more focused strategy and not a very it's not many markets. It's focused markets.

Speaker 9

Is it fair to say that if you take a next 2-3-year view, this probably could be the fastest-growing business for you in the entire consolidated revenues?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yeah. Currently, the scale-up is good. But as I said, there are potentials on also our home markets, which is U.S. and India, showing good growth. So I won't be 100% able to say this will be the fastest, but definitely, consistency-wise, it'll be a fast-growing market.

Speaker 9

Okay. Thanks. And on the U.S., for the last two quarters, we've made about $225 million of revenue, which is an excellent basis. Now, this obviously has a fair chunk of Asacol HD, I presume, in this base. Now, assuming there is a risk the competition for Asacol HD does materialize, I mean, do we have enough launches to offset this over the next couple of years?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes, more than enough.

Speaker 9

Okay. That's good. And on revenue mix, what should be a base assumption, similar sort of revenues, which we've done in 2024, or we should see a scale-up in revenues as we go through the next couple of years?

Sharvil Patel
Managing Director, Zydus Lifesciences

I think our current immediate expectation is some scale-up on revenues. For the year later, we'll still wait and talk about it later. But on the immediate basis, we would see some scale-up.

Speaker 9

That should reflect in Q4 and Q1?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Speaker 9

Okay. And lastly, you've talked about the point that you mentioned about it, that there have been enough opportunities for you to offset a possible Asacol HD genericization. I mean, if there is a way for you to sort of indicate over the next two years how many $25 million, $30 million-plus launches that we can potentially have in a basket?

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think exactly, I won't be able to give you the number right now. But definitely, in the next two years, we have important launches which will overall scale up the overall U.S. generics business. But as I said, even considering FY2026, 2027, 2028, we have very large, important launches. So we have a good pipeline of products where we will see limited or exclusive launches.

Speaker 9

Okay. Thank you so much.

Operator

Thank you. The next question is from Kunal Dhamesha.

Speaker 10

Hi. Thank you for the opportunity again. So there is 1-2 very large opportunities per year till 2027, 2028 that we have said. In terms of risk mitigation, would these 8-10 products be filed from multiple plants of ours, or they are currently a single plant filings?

Sharvil Patel
Managing Director, Zydus Lifesciences

No, this is all diversified both from plant dosage form and partnered-in products. So it's not anything related to a specific plant.

Speaker 10

Right. So in case.

Sharvil Patel
Managing Director, Zydus Lifesciences

30 of the products I'm talking about are already filed. For to be filed products, obviously, I don't want to give an early indication without filing them.

Speaker 10

So we have done the risk mitigation for these key large opportunities is the way to understand it, right? Not a single plant would, so every key product will have two plants as a manufacturing site?

Sharvil Patel
Managing Director, Zydus Lifesciences

That is never possible. All products will not have two plants. But all products are not from one plant.

Speaker 10

Okay. Okay. Perfect. And in terms of, let's say, if I have to bucket these 8-10 products based on what they are contingent on from the launch, A, one is settlement, B, court litigation, and C, probably the development front, how would you bucket these 8-10 products? How many would have been settled, which we are just waiting for that deadline to hit as we can launch? And how many are under court litigation right now?

Sharvil Patel
Managing Director, Zydus Lifesciences

Majority of what I have just spoken of are all settled products. To be settled products and to be filed products, still we are waiting. I mean, we are not talking about those right now.

Speaker 10

Okay. Perfect. Thank you, and all the best.

Operator

Thank you. The next question is from Nitin Agarwal.

Speaker 11

Hi. Thanks for taking my question again. Sharvil Patel, on Zydus Lifesciences, what is the kind of fair share of market share that you can target over the next two years? I guess that's when the exclusivity lasts for us.

Sharvil Patel
Managing Director, Zydus Lifesciences

So as I said, it's still early days. I think I can give a better picture maybe two quarters down because both negotiations with PBMs, the right channel, the prescription, all is required. So I don't think it's a quick buildup. So generally, success on 505(b)(2)s has been limited. So we are still very from whatever early traction we are seeing, we'll see good we are seeing some good opportunity, but it still has to play out. So I would say still early days. But definitely, from whatever we are seeing currently, our best estimate is that this will be a valuable these first two products will be a valuable launch.

Speaker 11

Okay. Got it. Thank you.

Operator

Thank you. The next question is from Harith Ahamed.

Speaker 12

Hi. Hope I'm audible. So my first question is on the other operating income for the quarter. There is roughly INR 50 crore quarter-on-quarter delta there. So can you give some color on that?

Sharvil Patel
Managing Director, Zydus Lifesciences

Other income?

Speaker 12

Other operating income.

Sharvil Patel
Managing Director, Zydus Lifesciences

Yeah. So I think Arvind can give you that. Yeah.

Ganesh Nayak
Executive Director, Zydus Lifesciences

Yeah. So Harith is largely driven by incremental export incentive and processing income and small portion of license fees for a couple of outlicensing deals that we had. But it's consistent with export incentive and processing income, largely. Okay. So on the injectables business in the U.S., a few quarters back, we had talked about a $150-$200 million kind of target from that portfolio. So how has the ramp-up been? Any update that you can provide on that front?

Sharvil Patel
Managing Director, Zydus Lifesciences

I think the business is tracking better than what we had planned. I think it's going in the right direction right now. We are seeing good opportunities with shortages as well as the complexity of regulatory approvals and as well as the quality. I think the opportunity seems to be good, and we are doing better than our plans.

Speaker 12

Okay. And last one on the transdermal side, a couple of launches that you had done during the quarter. So when I think of FY25, how material can transdermals be for us? Can it be a $50 million-plus revenue stream from all the launches and transdermals?

Sharvil Patel
Managing Director, Zydus Lifesciences

So yes, the potential definitely for our portfolio is about 50-60. It won't be in FY25. But in the next 1-2 years, yes, it can be a $50-$60 million opportunity.

Speaker 12

All right. Thanks for taking my questions.

Operator

Thank you. The next question is from Devang.

Speaker 13

Hello?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Speaker 13

Sir, when we are planning to partner for respiratory therapy in the U.S. market, will we see this in FY25?

Sharvil Patel
Managing Director, Zydus Lifesciences

No, it's a little longer term. It is still under the development stage. We have to wait a couple of years before we can talk about it.

Speaker 13

Okay. My next question is, could we see double-digit revenue growth for FY25 and beyond?

Sharvil Patel
Managing Director, Zydus Lifesciences

I think once we finish this year, we can talk a little bit more about the next year. But as I said, going forward in the next quarter four, we are seeing good traction driven by U.S. and good base business. And we continue to hope to build that momentum.

Speaker 13

Thank you, sir.

Sharvil Patel
Managing Director, Zydus Lifesciences

Thank you.

Operator

We will wait for a few minutes for the question queue to assemble. Whoever wishes to ask the question, please click on the raise the hand button. The next question is from Unnati Jadhav , just have one question specifically for the US market

Speaker 14

Why has there been a decline on a year-over-year and quarter-over-quarter basis in this quarter for the US sales?

Sharvil Patel
Managing Director, Zydus Lifesciences

Can you repeat what you just asked? We couldn't hear you well.

Speaker 14

Well, I just wanted to understand why there has been a decline in the U.S. sales in this quarter, 4.3% on a year-over-year basis and 1.2% on quarter-over-quarter basis.

Sharvil Patel
Managing Director, Zydus Lifesciences

So I think the US business, the right way to look at it is quarter-over-quarter versus year-on-year. Last year, we had Revlimid sales, which is not there this year. But I think the right metrics is to look quarter-over-quarter. And quarter-over-quarter, we are almost flat. And as I said, the last quarter is always where the distributors normally destock or at least manage their inventories. So we don't see any concern with this. This is as per expectations of quarter four.

Speaker 14

So.

Sharvil Patel
Managing Director, Zydus Lifesciences

Sorry, quarter three.

Speaker 14

Okay. So there was absolutely no sales of Revlimid in Q3 of 2024?

Sharvil Patel
Managing Director, Zydus Lifesciences

Yes.

Speaker 14

Okay. But then do you believe that it will continue to be the case for the coming quarters, or will it kind of resurge again?

Sharvil Patel
Managing Director, Zydus Lifesciences

It'll resurge again next quarter.

Speaker 14

Okay. Okay. Okay. Thanks. Thanks.

Operator

Thank you so much. As there are no further questions from the participants, I now hand the conference over to management for the closing comments.

Kunal Dhamesha
Director, Macquarie

Thank you very much. Look forward to interacting with you again in the month of May for the last quarter results of FY2024. Thank you, and good night.

Operator

On behalf of Zydus Lifesciences Limited, that concludes this conference. Thank you for joining us. You may now disconnect your lines and exit the webinar. Thank you so much.

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