Dr. Reddy's Laboratories Limited (500124) Earnings Call Transcript & Summary

October 23, 2026

BSE IN Health Care Pharmaceuticals earnings 64 min

Earnings Call Speaker Segments

Aishwarya Sitharam

executive
#1

Good day, everyone, and welcome to quarter 2 FY '27 Earnings Call of Dr. Reddy's Laboratories. We appreciate your confident interest in our company. I'm Aishwarya Sitharam, Head of Investor Relations at Dr. Reddy's. Joining us today are members of the leadership team. Mr. Erez Israeli, our Chief Executive Officer; and Mr. MV Narasimham, we call MV, our Chief Financial Officer. Our quarterly financial results have been published earlier today and are available on our website for your reference. We will start today's call with [indiscernible] providing an overview of our financial performance for the quarter. Following that [indiscernible] will share his insights on key business highlights as well as the company's strategic outlook. We will then open the floor for questions. All commentary and analysis during this call are based on our IFRS consolidated financial statements. Please note that certain non-GAAP financial measures may also be discussed. Reconciliations to the corresponding GAAP measures are included in our press release. I would like to remind everyone that the safe harbor provisions outlined in today's press release apply to all forward-looking statements made during this call. Before we proceed, I would like to call out a few housekeeping points. All participants will be in the listen-only mode during the opening remarks. Should you need any technical assistance during the call, please use the chat function on your Zoom application. The chat will not be monitored for any questions to the management. This session is being recorded, and both the audio and the transcript will be made available on our website. Please note that this call is a proprietary material of Dr. Reddy Laboratiries Limited and may not be rebroadcasted or quoted in any the acholic forum without prior consent from the company. With that, let me hand the call over to MVN to present the financial highlights for the quarter. Over to you, MV.

Mannam Venkatanarasimham

executive
#2

Thank you, Aishwarya. Greetings, everyone, and thank you for being with us today. It is my pleasure to take you through our financial performance for the second quarter of FY '27. The business reported a 1.5% year-over-year decline in revenue, while EBITDA margin was at 20.6% for the quarter. Excluding lineman in North America, the underlying base business maintained its growth momentum, delivering double-digit growth. All financial figures in this section are translated into U.S. dollars using a convenience translation rate of 95.83 the exchange rate prevailing as of September 30, 2026. Consolidated revenues stood at INR 8,671 crores, which is USD 95 million, a decline of 1.5% year-over-year and a growth of 7.4% on a sequential basis, strong underlying base business performance across Key businesses, except Europe and API driven by new product launches and favorable ForEx movements helped mitigate the impact of lower lined sales. Consolidated gross profit margin was 52.1%, an increase of 62 basis points sequentially and a decrease of 254 basis points year-over-year. The year-over-year decline in margins during the quarter was largely on account of lower met sales. As a reminder, margins in the preceding quarter were adversely impacted by a provision for inventory and other costs associated with the [indiscernible] related challenges. The reported gross margin for Q2 FY '27 was 56.2% for global generics and 11.8% for PSA. The SG&A spend was at INR 288 crores an increase of 6% year-over-year and a decline of 3% sequentially, according for 32% of revenue. The year-over-year increase was primarily driven by higher personnel costs following annual increments adverse ForEx movement as well as elevated freight costs due to supply chain disruptions arising from the Middle East crisis. The R&D spend was at INR 54 crores down by 16% year-over-year and 9% sequentially, accounting for 6% of revenues and primarily reflecting lower development expenditure in the generics as compared to the previous year. The EBITDA, including other income stood at INR 173 crores, which is USD 186 million, a decrease of 14 basis points year-over-year, an increase of 8 basis points sequentially, reflecting a margin of 20.6% of the revenues for the quarter. The profit before tax was at INR 1,228 crores, that is USD 128 million, representing a margin of 14.2%. Effective tax rate for the quarter was at 25.6% compared to 22.2% in the responding period last year. The year for the quarter was higher, primarily due to an adverse durational mix for the quarter in comparison to the same period in the previous year. Profit after tax attributable to equity holders of the parent for the quarter stood at INR 925 crores, which is USD 197 million, a margin of 10.7% in revenues. Diluted EPS for the quarter is at INR 11.1%. Operating working capital as of 30th September 2026 was INR 14,650 crores, which is USD 1.53 billion, an increase of INR 297 crores for 30 June 2026. Cash CapEx, cash outflow for the quarter stood at INR 186 crores, which is USD 19 million. Cash flow during the quarter was INR 171 crores, which is $18 million. As of 30th September, we have a net cash surplus of INR 72,500 crores. Which is USD 61 million. Foreign currency cash flow had just executed through derivative instruments during the period of USD 229 million hedge using a combination of forwards and risk reversal option. -- due to mature by March 2027, these contracts are hedged at a rate of EUR 95.32, USD 95.44. With this, I now request Erez to take us through the key business highlights.

Erez Israeli

executive
#3

Thank you, MVN. Good day. Thank you for your continued interest in our company. I apologize for my voice. I hope it will stay consistent. We remain consistent with -- in our strategic priorities of delivering double-digit growth across geographies and sustainable profitability and to strong execution in our core businesses, focus on key assets, continued productivity improvement and disciplined investment in future growth drivers, both organic as well as inorganic. During the quarter, the underlying business that is excluding [indiscernible] in North America continued to perform well, delivering a double-digit growth overall as well as across North America emerging markets and India. We achieved an EBITDA margin of 20.6%, supported by the strength of our base business and our continued effort to drive productivity. Subject to successful validation, we expect to relaunch semaglutide [indiscernible] directly as well as to our partners in November 2026 and consistent with the time lines communicated earlier. We also remain focused on advancing Abatacept and other content generics as they move through the regulatory review process in the coming quarters. Let me now walk you through some of the key highlights of the quarter. We partnered with Takeda to bring India first approved dengue vaccine. We call it fuel diner to the private markets in India in the first half of 2027. We expand our collaboration with Gilead science to enable access to investigational once early lenacapavir for HIV prevention in 120 countries. In collaboration with the GARP Foundation, we secured approval for oliphodocin and antibiotic use gonorrhea treatment in Thailand within 6 months of USFDA approval. We received USD appeal for rituximab biosimilar, which will be commercialized in the U.S. through our partners, [ Fresenius Kabi ]. We launched nivolumab in India, marking our entry to biosimilar immuno-oncology in India, both rituximab and nivolumab are developed and manufactured in-house. Generic semaglutide is now prove in 10 countries across Latin America, Africa, the Middle East as well, of course, as Canada and India. Our CDMO business under Origin Pharmaceutical Services generated revenues over $100 million in the last 12 months. We continue to receive global recognition for commitment to sustainability, Finance Asia Awards, a silver medal in the best large cap company in India category as Asia best companies 2026, reflecting strong endorsement by the Asian investor and analyst community. We improved our CRISIL [indiscernible] to 73 out of 166, becoming the only pharmaceutical company in the leadership category. Let me take you through the key business highlights for the quarter. Please note that all financial figures mentioned are reported in the respective local policies. Our North America generic business reported revenue of $64 million for the quarter, accounting for 29% of our overall revenues and reflecting a decline of 29% year-on-year and a growth of 12% sequentially. The decline is attributed to [indiscernible] sales versus last year. The underlying base business, excluding lenadulemide, continued to deliver strong double-digit growth, driven by new product launches -- during the quarter, we launched 6 new products, including first-to-market launch of sugammadex injection. We remain on track to launch additional products, including complex injectable during the year. Our branded traces comprising India emerging markets and consumer health business in nicotine replacement therapy or NRT together accounted for 53% of our overall revenue and continue to provide a strong foundation for stable margin for the company. Our emerging market business recorded revenue of at INR 2,059 crores, accounting for 25% of our overall revenue and flagging a robust growth of 24% year-over-year and 12% Q-on-Q. New product launches across markets, including acquisition, coupled with favorable currency movement drove growth during the quarter. We introduced 27 new products across countries in Q2 FY '27. Our India business revenues were INR 1,851 accounted for 21% of overall revenues and consistently delivering a robust double-digit even-year growth of 17% and an sequentially. Cost was driven by recent launches, including acquired brands, along with price increases and higher volumes. According to IQVIA, September 2026 data, our IPM rank improved to 8% for the quarter and for the year. We continue to outperform the Indian pharmaceutical market IPM with moving quarterly total growth of 21% versus 14.7% for IP and moving annual total MAT growth of 19.4% versus 13.2% for the market. Four of our brands feature in IBM top 50 new launches and we launched four new brands during the quarter. Our European business which include NRT posted revenue of PHN127 million for the quarter, accounting for 16% of our overall revenues. Revenues declined 6% year-over-year and 3% sequentially on account of price erosion in generic, partially offset by revenues from new product launches. Growth was further affected by the continued impact of the operating model changes post NRT integration, as highlighted last quarter. During the quarter, we launched 6 new generic products across markets. Our PSAI business reported revenue of $88 million, accounting for 10% of the overall revenues. Revenue decline of 19% year-over-year and sequentially. Primarily on account of lower API volume uptick, our CDMO business delivered double-digit growth this quarter during the quarter. We filed 28 drug master files globally. We remain committed to improving the health of our business and to deliver consistent growth and sustainable margins as we continue to strengthen our core business, we are also investing in a future growth driver across peptides, biosimilar, consumer health and innovation. Our focus remains on progressing key products such as semaglutide and abate driving operational efficiency and pursuing targeted inorganic opportunities to support long-term growth and shareholder value. With that, I invite your questions as we move into the Q&A sessions.

Aishwarya Sitharam

executive
#4

Thank you very much, Erez. We will now begin the question-and-answer session. [Operator Instructions]. The first question is from the line of Neha Manpuria from Bank of America.

Neha Manpuria

analyst
#5

My first question is on semi. I think you mentioned that we are on track to resume summer in early November. It is -- I think you had given us a volume guidance last time when we announced the disruption in supplies. Two questions on sema first. Is the resumption happening with our own API? Is it the same partner that we're using? And second, given what has happened in Canada, with one player which is already there, how confident are we of meeting the guidance that we'd given for [indiscernible].

Mannam Venkatanarasimham

executive
#6

So I'm very confident. The confidence is based on orders that we already have. We just obviously to supply. The main issue was with our ability to scale up the this probably be sold, and we shipped all the necessary API to our partner to do. We still need to have the result of the validation. So this is still pending, but I'm confident that it will be successful. And then we are ready to launch. Most of the quantities will go to Canada and some of the quantities will go to Latin America, primarily to Latin America and it's a bit area.

Neha Manpuria

analyst
#7

Understood. And my second question is on the gross margin improvement that we have seen in the quarter. MBM, if you could give us some color in terms of what's driving this gross margin improvement. And is it fair to assume that as Hema comes through, this is the bottom in terms of gross margin and gross margin should only improve from here?

Mannam Venkatanarasimham

executive
#8

Yes. They had just as we guided earlier, we want to be gross margin in the 50% to 55%. That's why this quarter, what we see [indiscernible] this improvement from last quarter to even this quarter is a combination of the new products and the business mix. That's where I think we will be in this one, certainly in the coming quarters as well.

Erez Israeli

executive
#9

And your assumption is correct. Yes. It will only go better from here.

Aishwarya Sitharam

executive
#10

Thanks, Neha. The next question is from the line of of Dr. Kunal Dhamesha from Macquarie.

Kunal Dhamesha

analyst
#11

First one on the one cash flow line item. On other assets and liabilities, there is a large change that has happened around INR 1,370 crores. So MVN, could you please help us what is driving that?

Mannam Venkatanarasimham

executive
#12

So this is not one where this SSA claim what we had. I think there was the payments have happened this quarter. That is one change and then other balances due to various operations. But that is the biggest one. That's -- if I remember about $50 million, what we have provided in the Q4. During the H1.

Kunal Dhamesha

analyst
#13

Okay. So the cash flow has [indiscernible] Great. And just continuing on the gross margin front. Or the other way to look at is there is a sequential improvement in U.S. revenue, a meaningful improvement, right? So would you be able to split between the new product launches driving that and the volume improvement in existing product or pricing improvement, how should we think of the delta in U.S. business? And the similar driver and approximate split for the gross margin improvement on a Q-o-Q basis?

Mannam Venkatanarasimham

executive
#14

So certainly, like in new products, what we have launched in [indiscernible], I think in the U.S., contest products. as compared to the -- our company average gross margins, I think, certainly is like on the higher side as well as what we have launched the nivolumab. And we see the business mix also has contributed to this margin. So Kunal, the main driver in driver is actually the business mix because.

Erez Israeli

executive
#15

Now the businesses that are relatively with high profitability, meaning India, EM and the NRT, all of them are much more profitable than our average went to 53%. So this is one contribution. The second is what MVN said that the U.S. is more profitable because of the contribution of the new products. The combination of both that and the last we did not increase the expenses. Expenses are essentially flat this quarter. And so if you grow the sales double digit and you don't increase their cost is obviously lead to this margin improvement.

Kunal Dhamesha

analyst
#16

Sure. And lastly, from my side, would we have also seen some drag from the raw material price increase and given the -- I think the oil prices are high and the chemical prices are also high. And then how should we look at that cost line item from the, let's say, second half perspective, do you think that quarter 2 is when we have seen most of the increase or quarter 3, quarter 4, we can see [indiscernible]?

Mannam Venkatanarasimham

executive
#17

So here, just I think is because of the war. I can say, increases of what we have seen in the KSMs and then the second one is solvent. And the third is like logistics, quite outwards what we are exporting metal from India to all countries. So we have seen the increase in the -- on the 3 fronts. And then overall, it has an impact close to 100 basis points on -- so we believe that's already part of the gross margins. And then we believe, I think this trend will continue for Q3 and Q4 as well.

Erez Israeli

executive
#18

I don't anticipate traditional growth unless, of course, there will be as much as we can predict additional geopolitical issues. But with our limited understanding if it will stay the way it is now, we are in the same place.

Operator

operator
#19

The next question is from the line of Damayanti Kerai from HSBC.

Damayanti Kerai

analyst
#20

It is a clarification on semaglutide resumption. So you mentioned you have already started supply of API to your partner bill and finish partner. However, what is remaining is the validation. So I actually am not clear I thought like validation will be done and then you will supply to your fill and finish partners. So can you just help us understand this?

Erez Israeli

executive
#21

Sure. So you do validation as we had to come back and basically tweak the process on the AP. Then you do validation of the API. And then when you ship it to our partner, then you know and you need now to do validation on the drug product using the API. This is a process that takes about 3 weeks. And so far, give or take the all the activities are on time. And that's why it took us to November from the first place. So, so far, it is a right direction, but you have basically validation in each stage of the scale-up of the process.

Damayanti Kerai

analyst
#22

Sure. That's helpful. And other point on semaglutide, you mentioned so far, it's approved in around 10 countries. So didn't you secure for more approvals in other markets while you are trying to resolve the API issue? Or you want to go after you resume the supplies in the existing or approved market. So how do you plan -- because you mentioned you'll be targeting to launch in more than 70 countries across the world, right?

Erez Israeli

executive
#23

The right number is now 89 markets. But it just that all the markets that the process started, we did not stop. The scale-up issue has nothing to do with the regulatory process, and we don't require any amendment to the file or anything like that. So I wish continued. And all the approval we got was in according to the process in each one of those respective countries, and this will continue. Some of the approval in some other markets, good delays because of the scale up as we needed to ship them samples of the products, and those samples will be now sent to these places. So we will continue with the process for all the other markets as well.

Damayanti Kerai

analyst
#24

Sure. And my second question is on your -- the nicotine business. So flat performance for last 2 quarters. And you mentioned it was due to change in the business model. So when we should see recovery in NRT business?

Erez Israeli

executive
#25

So last year or last quarter, if you recall, we had to carve out form Helion. So it means that [ Alion ] used to do it, and we gave them certain margins for handling the business. The new business model, it means that now we are selling it either by ourselves or through distributors and -- but the payment to Alion is not there anymore. It means normally in this respect less sales, and -- but more of it. So what I can say about it is the comparison year-over-year will be until we will finish the year, see we have two more quarters like that. In general, the business is doing well. It will grow in the same way that you saw until now, some of between high single digit to maybe even double digits. And the profitability is way above the expectations that we put in the business model. So we're very, very pleased with this one.

Aishwarya Sitharam

executive
#26

The next question is from the line of Tausif Shaikh from BNP Paribas.

Tausif Shaikh

analyst
#27

First question on [indiscernible] while the goal date is set for December. Is there any incremental update that you would like to share with us, especially from the [indiscernible]?

Erez Israeli

executive
#28

Yes. So the plant went for the inspection. We are still waiting for the IR to come. And the gold eat is indeed December 22, and we and we are hoping for an approval. It's obviously in the end of the U.S. FDA.

Tausif Shaikh

analyst
#29

Okay. That's helpful. On the R&D expense, which seems lower compared to Y-o-Y and Q-on-Q, well, you have mentioned is on account of lower spend on global generics. How do you see this trend going ahead? Shall we assume this is a new base now?

Mannam Venkatanarasimham

executive
#30

So this quarter's R&D is low, absolutely, you're right. And then coming quarters, what we believe our R&D is going to be in the range of 7% to 8%.

Aishwarya Sitharam

executive
#31

the next question is from the line of Madhav Marda from Millennium.

Madhav Marda

analyst
#32

Just one question. If I understood right, during the initial remarks, you mentioned about like one or a few complex injectable launches in the second half of the year. Could you just clarify like if you could share some more views on that product? Do I hear that right that we have some complex injectable line?

Aishwarya Sitharam

executive
#33

Well, we'll talk about it more when we get closer towards the end of the year. But yes, we do have a few interesting products in our pipeline. We've always spoken about that. We've done a bunch of launches. We want to continue over that momentum.

Erez Israeli

executive
#34

Yes. But I'm kind of careful to promise because I got burned in the past when dealing with the ruble of complex generics and some of you have been with us for many, many years, and you remember that. But let's say, we have some exciting products ahead.

Madhav Marda

analyst
#35

And [indiscernible], we've done the analyst meet in Bombay, I think that we had shared names of a few products -- is it from that list itself? Like do you like to disclose 45 products in the pipeline?

Aishwarya Sitharam

executive
#36

You will know by the end of the year.

Madhav Marda

analyst
#37

Okay. Okay, fine. But it's a meaningful product for the U.S. market. Is that right?

Erez Israeli

executive
#38

These are meaningful products, yes.

Aishwarya Sitharam

executive
#39

The next question is from the line of Foram Parekh from Bank of Baroda Capital.

Foram Parekh

analyst
#40

Thank you for the opportunity. My first question is on Europe business, of NRT the growth seems to be declining there, probably because of Germany. So how should we look at it? I mean NRT is also now flattish because of the change in business model and exofNRT also, it's declining, which is taking a toll on the Europe business. So can we expect it to go back to double digit.

Erez Israeli

executive
#41

Yes, it will. First of all, the NRT will grow. The NRT is growing and obviously, that part will positively impact also the relevant part of Europe. Absolutely, you are correct about the performance of this quarter. the next quarter should be better. Let's say, the NRT I'm expecting, again, either high single-digit growth or even double depends on certain scenarios. As for Europe, I'm expecting growth, but it will not be significant growth this year.

Foram Parekh

analyst
#42

Sure. And on XOF NRT, how should we look at growth ramping up?

Erez Israeli

executive
#43

X Europe, you mean?

Foram Parekh

analyst
#44

Yes.

Erez Israeli

executive
#45

It should grow probably single digit.

Foram Parekh

analyst
#46

Okay. That's helpful. My second question is on SG&A cost. Here also, the contribution has come lower to 26% versus earlier trend of 29%. So would this be the new sustainable number to look at?

Mannam Venkatanarasimham

executive
#47

Yes. So overall, I just want to clarify, our S&A percentage [indiscernible], we've also spoken the cost productivity, what we are doing is now that is becoming visible. So even coming quarters also at least in this year coming -- you may not see like significant changes to this number. It's going to be at this level around year and there, I think small changes.

Erez Israeli

executive
#48

I just want to reiterate to take the opportunity. We believe that the level that we agreed and we discuss it all the time, actually, with all of you, is sustainable. We think that the 20 plus, we actually mean for the famous 25%, but we are always discussing EBITDA, EBITDA. And this will continue and we are planning to consistently continue to deliver on this number.

Foram Parekh

analyst
#49

Sure. And last question is on the India business. So we have done good and IPM growth also is inching up in double digit and is likely to sustain at current levels for the remaining year. So can we expect a current run rate of 17% to be the growth rate for the year?

Erez Israeli

executive
#50

It's going, obviously, to stay high level of double digit. It's maybe a little bit lease or a little bit more, but we are in the right neighborhood. Also, we want to be -- our growth want to be like higher than the market growth at 2 basis points.

Aishwarya Sitharam

executive
#51

Participants are requested to restrict the number of questions to ensure that everyone on the -- in the queue gets an opportunity to interact with management. The next question is from the line of Prakhar Nema who is from BNY Mellon.

Unknown Analyst

analyst
#52

Firstly, thanks for the question. So what is the company's strategy for expanding the biosimilar business through within research and development and partnership. So could you please share some light on this?

Erez Israeli

executive
#53

Sure. We are going after both. So we're naturally leveraging our back facilities as well as additional facilities that will build in the future. And [indiscernible] is going to be the first meaningful product to be launched out of our own facilities. Rituximab is obviously one of them. But I said we're going to be obviously meaningful and more products to follow. In parallel to that, we are we are talking to partners around the world, and we are trying to license products in which we don't have in our own pipeline and our own internal pipelines. And we have it whether globally or for specific regions. So both will continue.

Unknown Analyst

analyst
#54

Perfect. And one more question. So what the revenue we can expect for the next 3 to 4 years?

Erez Israeli

executive
#55

It depends on the success of test obviously, in the next coming years because this is going to be a significant product for that. And Abatacept should be in the 100. So you should expect hundreds of millions of dollars. So followed by [indiscernible], then we have a pembro and daratumumab also will come in the next within 5 years.

Aishwarya Sitharam

executive
#56

The next question is from the line of Abdulkader Puranwala from ICICI Securities. Please go ahead. Abdul new will come back to you. The next question is from the line of Vishal Manchanda from Systematix.

Vishal Manchanda

analyst
#57

On rituximab, would it be possible for you to share? Where are we in terms of market share in Europe?

Erez Israeli

executive
#58

We have a single digit of market share in Europe. Low single digit or high single digit.

Vishal Manchanda

analyst
#59

Any time lines and any guidance as to where we can be maybe a year or 2 years down the line? And do we have the capacities there?

Erez Israeli

executive
#60

So indeed, we were constrained by capacity. We should be better we will be able to add more qualified capacity for that. And at the same time, we are talking about the product with a high level of competition. So I would not expect a significant change because of this.

Vishal Manchanda

analyst
#61

Okay. And second, your JV entity in China got a first generic approval for a drug called [indiscernible] July. Is that contribution part of your numbers in the current quarter? Or will this come in subsequent quarters?

Erez Israeli

executive
#62

So we are recording our share of the -- so we are not recording the sales. We are recording our share of the profit of that it's the profit and our share in that, which is 51%.

Vishal Manchanda

analyst
#63

So this would be part of the JV -- share of profits from JV?

Erez Israeli

executive
#64

[indiscernible].

Vishal Manchanda

analyst
#65

So have we kind of started selling this? And is this now -- have you ramped up to our full potential? And are we the only generic here or there are other generics that have entered.

Erez Israeli

executive
#66

To the best of my knowledge we started, I don't recall about the competition.

Vishal Manchanda

analyst
#67

Okay. And just one final one on Abatacept, once we get the approval, how long can we take to get listed on the formularies? Will it be like 6 months? Or we can start getting market share quickly post approval?

Erez Israeli

executive
#68

So the ramp-up, like you said correctly, will be after 6 months after we'll get all the codes and all the registration. The -- but we can initially sell smaller quantities from day 1. So expect that the launch will be upon approval, but the ramp-up will be correctly after 6 months.

Vishal Manchanda

analyst
#69

if I can ask one more on semi, if you can guide on where generics are in terms of market share in Canada as on date?

Erez Israeli

executive
#70

As of date, there is only one generic in Canada. Like I don't remember their market share. But let's say that the Canadian market will have to get as well.

Aishwarya Sitharam

executive
#71

The next question is from the line of Surya Patra from Philip Capital. While Surya joins back in. The next question can be from the line of Dr. Bino Pathiparampil from Elara Capital.

Bino Pathiparampil

analyst
#72

Good evening to all of you, and citations on a great set of numbers. A couple of clarifications. I see from the footnotes these bendamustin deal and some milestones in Russia, which is part of revenue. Where is it included in the revenue breakup? Is it part of U.S. and Russia Avenue respectively?

Mannam Venkatanarasimham

executive
#73

It is in the sales line.

Bino Pathiparampil

analyst
#74

And bendamustin is in the U.S. revenue and the milestones are in the Russian, am I right?

Mannam Venkatanarasimham

executive
#75

That milestone of Russia is part of the year.

Bino Pathiparampil

analyst
#76

Okay. Second, what is this [indiscernible] deal amount? What was the logic behind sending the product right, selling the product rights?

Aishwarya Sitharam

executive
#77

[indiscernible] licensing.

Mannam Venkatanarasimham

executive
#78

Yes. That's why I think here, we thought a partner, we will get overall as a deal and then we get a better economics. That's why we have taken given this right to the partner.

Bino Pathiparampil

analyst
#79

Got it. In the quarter, I've seen -- I see that the finance income is significantly lower versus INR 290 crore last quarter and kind of similar numbers in previous quarters. This quarter is only about INR 90 crores. So is there any reason why the finance income is so much lower?

Mannam Venkatanarasimham

executive
#80

So here, what the exposure we have on the balance sheet especially the movements from June to September of the ruble spot rate is, I think, significant variance. I think that has given this P&L debit, I think, in this quarter as compared to the Q1.

Bino Pathiparampil

analyst
#81

Sorry, in this quarter, it is lower compared to Q1?

Mannam Venkatanarasimham

executive
#82

Yes, yes.

Bino Pathiparampil

analyst
#83

I'm sorry, one last question. What will be the CapEx for the full year? Because the first half I have seen is much lower than your typical rate.

Mannam Venkatanarasimham

executive
#84

Earlier, we have guided around INR 1,800 crores in my view, it could be a little lower, but definitely I expect around INR 1,600 to INR 1,700.

Aishwarya Sitharam

executive
#85

The next question is from the line of Amlan Das, JPMorgan.

Amlan Das

analyst
#86

Sorry. Just wanted one clarification on the hepatic scenario. So apart from the IV indication, we also heard from the previous calls that for a subsidies indication you expect an approval in the U.S. in 4Q FY '28. And in the non-U.S. markets for both indications in 1Q FY '28. So does -- so do the times remain consistent or has Gemini change in this?

Erez Israeli

executive
#87

Consistent. [indiscernible].

Amlan Das

analyst
#88

Okay. And the non-U.S. market also roughly $1 billion of for the reference drug. So how do you expect the ramp-up in the non-U.S. markets for you for [indiscernible]?

Erez Israeli

executive
#89

We believe that the European market is a very important market for this. It's -- and it's going to be launched a little bit after the United States, but Europe is, we believe, is a significant market.

Amlan Das

analyst
#90

Okay. And lastly, for these markets, the manufacturing would be done in [indiscernible] itself, right?

Aishwarya Sitharam

executive
#91

The next question is from the line of Dara Ganatra from UTI Pension Funds.

Unknown Analyst

analyst
#92

So I had one question, largely from the Indian market perspective. What we have seen in the last 2 years is that IPM growth has been in single digits, high single digits. And in the last 6-odd months or last 3-odd months, what you are seeing that the growth has accelerated versus the last 2 years, the growth was more driven by pricing this time around, there's a lot more volume growth. So both for Dr. Reddy and for the industry, what do you think is changing? And what is the outlook for the second half of the year and going forward?

Erez Israeli

executive
#93

One thing that changed significantly is obviously the launch of semaglutide and the GLP-1 product. This is a significant addition both for volumes. The second one is that you have more new products like our innovative products that are coming to the market. So in general, this is the main contribution. I believe that if you take the GLP-1, you'll get either close to the single digit or to [indiscernible] do the math, but this is the main contribution I believe.

Unknown Analyst

analyst
#94

Okay. So you don't see any smaller players vacating the market or a slowdown in trade generics or that sort of that would be driving the IPM growth?

Erez Israeli

executive
#95

I don't -- the main at least the way I see also that the main growth for us is in the places in which you have those actions demand is -- for us, it's primarily the innovation. The branded generic dose that we are investing behind are doing well. The reps are doing like in the market, like normally mostly driven by prices.

Aishwarya Sitharam

executive
#96

We're going to try and see if Abdul can join us now. Okay. Looks like it's continued technical issues at his end. The next question will be from line of Vivek Agrawal from Citi.

Vivek Agrawal

analyst
#97

My question is on Abatacept. So -- just trying to understand what can be the fair market share of your biosimilar in the U.S., let's say, what the product is there across the formularies, even 1 year 1 year down the line. because we have seen a lot of biosimilars that sometimes the market share remains rebound to around 10%, 15%. And some of the products get market share as high as around 50%, 60% kind of stuff. So what is your assessment based on the opportunity itself, competitive dynamics as well as your capacity and capability at what kind of the market share is a fair market share for this product for you?

Erez Israeli

executive
#98

Thank you. The -- at least at the moment, assuming that we'll get approval, we are alone. So in terms of competitiveness, it's us and the innovator. It's a medical benefit product in the United States. So the sensitivity to the price into market share is not as big as in pharmacy benefit. And I know you know that well. So we -- I believe that a fair market share can be any number for 15% to 25%. It depends, of course, on the success of the launch. We need also to add that once the subcu will come to the market is obviously going to add to the market share, which will come later. We are talking about February '28. So this is give or take. It's primarily about the sweet spot between market share and prices.

Vivek Agrawal

analyst
#99

Just a clarification on this, 15%, 25% is the entire water market you are talking about or only the IV versa?

Erez Israeli

executive
#100

Initially, it will be on the IV. I mean it could be that there will be some movement on that, but we will start with IV and the subcu will come in February '28.

Vivek Agrawal

analyst
#101

Understood. And in terms of confidence on approval based on your discussion with the FDA. So would you like to assign any kind of probability, how comfortable you are based on your discussion with the agency type of queries, et cetera. So what kind of the chances that you have in terms of approval? Or is there any possibility of getting CRM in December and approval may get delayed by 2 months, et cetera?

Erez Israeli

executive
#102

I'm 33 years in this business. And I had my starts for these predictions -- we feel good about the product. We feel good about the inspection. We feel good about the correspondence with the U.S. we want and be preparing to launch in December. If you ask me, is there a chance that we'll get the CRL, there is a chance. I don't want to -- obviously, none of us want it, but there is a chance.

Vivek Agrawal

analyst
#103

Understood. The second question was on the U.S. generic business trajectory, right? On a quarter-on-quarter, we have seen improvement, right? And a part of the improvement is also been driven by some of the products which may face competition in the incremental quarters, Q2 and Q3. So I just want to get your understanding how we should look at the U.S. numbers with the North American numbers on quarter-on-quarter. Is there any possibility of dip in 3Q, 4Q? Or you can maintain the current trajectory going forward in the next -- in the second half?

Erez Israeli

executive
#104

So for the U.S., we have -- one we discussed at -- the other is obviously semaglutide that are going. It's not the U.S., but it will going to be including in the North America sales. And also those complex generics the [indiscernible]. So if we will have that or the combination of that, we will actually grow versus the current state and for sure, sustain it. Yes, I believe that the numbers are sustainable. Naturally, we have to be doses after the 6 months that SKU, we have one SKU that has 180 that will obviously go down. I don't think it will impact significantly. So that's where we'll be able to absorb without a problem. So overall, I'm optimistic, but it obviously depends on our ability to be successful with those products that I mentioned.

Vivek Agrawal

analyst
#105

Understood. Just last question on margins because the reason I also asked a question on the U.S. business sustainability, that in the coming quarter, there's -- you are also indicating alluding that the R&D spend is also expected to go up, right? So I'm just wondering if R&D spend goes up, some of these products like bosutinib comes down. And in this quarter, you also had some impact of milestone income, et cetera. So just trying to understand from where you are getting confidence that you will be able to maintain close to around 20% kind of margins in the second half?

Erez Israeli

executive
#106

First, we know our numbers. But -- so I'm sharing that confidence against we will reach it, and it will even go higher. The reason that we feel it, first of all, is the growth that we see in EM in India with the consumer health as well as the United States. Second is the way we control the expenses. So indeed, R&D, we will have more, but we will have on the other expenses less and we are planning to continue to do that. So it's formally the mix, the growth and obviously, the continued launch of new products. So maybe a 20% or 21% is not impressive. We always say that we want 25. We are recovering from linadulimide, and that's what we are going to be. But I said it also before. Now I think people believe me, we will have 20% less. And if we will launch successfully the way I believe [indiscernible] will be more it will be 21% plus.

Aishwarya Sitharam

executive
#107

The next question is from the line of Tushar Manudhane from Motilal Oswal.

Tushar Manudhane

analyst
#108

Just one question from my side, what kind of price erosion we have seen in case of Sugammadex, those launch?

Erez Israeli

executive
#109

I don't recall the...

Mannam Venkatanarasimham

executive
#110

[indiscernible], I think whatever we have in sell contract and, I think, it's getting continued. I think a product launch.

Erez Israeli

executive
#111

Probably versus the innovator, I don't remember.

Aishwarya Sitharam

executive
#112

Maybe I can get back to you on this later, Tushar. The next question is -- and there's a follow-on question from Kunal. So next question is from the line of Mr. Kunal Dhamesha.

Kunal Dhamesha

analyst
#113

Just one on the Abatacept subcu filing. Where are we in that process?

Erez Israeli

executive
#114

We have support submitted, if I remember, quarterly in February.

Kunal Dhamesha

analyst
#115

February of 2027?

Erez Israeli

executive
#116

2027 if I remember correctly. Aishwarya will see if I'm -- will keep me on that.

Mannam Venkatanarasimham

executive
#117

[indiscernible] in that quarter, we are going to submit this.

Kunal Dhamesha

analyst
#118

Sure, sure. And another one on the complex [indiscernible] launch that we are basically looking forward in the second half. Are these -- or that product particularly is -- we are dependent on the IT outcome on those branches? Or -- is it more just the approvals?

Erez Israeli

executive
#119

Approvals. FD approval.

Kunal Dhamesha

analyst
#120

Are these beta 4 filings?

Erez Israeli

executive
#121

We launched an approval situation for now.

Kunal Dhamesha

analyst
#122

Sure, sure, sure. And lastly, on abatacept, you suggested that the ramp-up will happen a couple of quarters later as we get included in the formulary. But just one, when we launch, what kind of infra commercial infra do we require especially for the U.S. market? And when do we start the build-out of that?

Erez Israeli

executive
#123

So we have -- we started to do it already 3 years -- so the main framework of the sales market in North America is already there. We will hire a couple of more sales team. So the team that will cover certain geographies, this is still pending. But the lion's share of the team is there.

Kunal Dhamesha

analyst
#124

Sure. So there's not much incremental cost related to that?

Erez Israeli

executive
#125

No, not much.

Aishwarya Sitharam

executive
#126

The next question is from the line of Aman Vij from Astute Investment Management.

Aman Vij

analyst
#127

My question on the samalutide side. First, given we expect the validation to be completed by November, where are we in terms of launches in other big markets like Brazil and Turkey in terms of approval time lines and launch time lines and roasting.

Erez Israeli

executive
#128

Brazil likely in Q4, the beginning of Q4. And the rest of the market. So we will -- most of -- we are going to launch in all the smaller markets, either in the end of Q3 or at the beginning of Q4 and this is primarily the tightness of the time that we finish validation and we start to sell batch by batch some of it may come to the market in Q3, some will come in January. So all of it will be in that time frame, some in December, some in January.

Aman Vij

analyst
#129

That helps. Second question, you've talked about we are still adhering to our guidance of million devices this year. What are the latest estimates, say, for next 1 to 2 years, FY '28 and '29, where do you see this number?

Erez Israeli

executive
#130

It obviously depends on the success of this 6 to 7. But like I mentioned in the past, the run rate of 12 million to 15 million that we discussed in the past is still my estimate. But obviously, it can fluctuate as we understand better the market once we'll get all the approvals and we'll understand the competition in each one of the markets. So right now, tacit has a very tentative number. But this is what we are preparing for the, let's say, the 12 months for April.

Aman Vij

analyst
#131

You had mentioned the number last time I just want to understand, are you more positive on the number slightly negative, that point. I did not change in my attitude. It's -- because we need to see the success of the market share that we will take as well as the success and the market share of our partners. So I don't have any additional information. Right now, it's the same consistent with what we discussed in the past.

Aishwarya Sitharam

executive
#132

In the interest of time, we will take one last question from the line of Saion Mukerji from Nomura.

Saion Mukherjee

analyst
#133

Just one question on the PSAI segment. The growth has been muted for a while. So how you see that growth playing out? You also mentioned the CDMO revenues at $100 million plus. If you can give a color -- some color on the nature of this revenue? Is it generics or innovation related? And also the new contract that you signed when you expect that to kick in? Is that meaningful? And any other CDMO contracts that can be added over the next year or so?

Erez Israeli

executive
#134

Thank you, Saion. So on the CDMO, I believe that the growth trajectory will come. It's a combination of growth in discovery, what we call innovation. So this is growing in double digit. We have also certain contracts with big companies in which they want to transfer their production into our line. So we have several of these projects and as well as a normal CDMO, meaning that we are doing projects for Phase III, Phase II for innovative companies. I believe that the that this business should grow and should reach 2x to 3x of this number in the next 3 to 4 years. This is still our plan, I believe that we should be the -- on the API side, part of it is that our older products have less demand. And part of it is because most of our launches and most of our activities are done more as a B2B of finished product. This is actually going well. Part of it. We are recognizing as part of PCI. And part of it, we are recognizing as part of the relevant North America. So overall, the B2B is actually growing the API merchants part of it is declining because most of the product, the peptides and this kind of stuff people prefer to buy the finished goods rather than to buy the guy.

Aishwarya Sitharam

executive
#135

That was the last question. Thank you all for joining us today. We value your time and participation on this call. If you have any further questions or need any additional information, please do feel free to reach out with me. With that, we conclude today's earnings call. Thanks, everyone.

Mannam Venkatanarasimham

executive
#136

Thank you.

Aishwarya Sitharam

executive
#137

Thank you.

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