Dr. Reddy's Laboratories Limited (BOM:500124)
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Q2 22/23

Oct 28, 2022

Operator

Ladies and gentlemen, good day, and welcome to Q2 FY 2023 earnings conference call of Dr. Reddy's Laboratories Limited. As a reminder, all participant lines will be in the listen only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Amit Agarwal. Thank you, and over to you, sir.

Amit Agarwal
Head of Investor Relations, Dr. Reddy's

Thank you. Very good morning and good evening to all of you. Thank you for joining us today for the Dr. Reddy's earnings conference call for the quarter ended September 30, 2022. Earlier during the day, we have released our results, and the same are also posted on our website. This call is being recorded and the playback and transcript shall be made available on our website soon. All the discussion and analysis of this call will be based on the IFRS consolidated financial statements. To discuss the business performance and outlook, we have the leadership team of Dr. Reddy's comprising Erez Israeli, our CEO, Mr. Parag Agarwal, our CFO, and the investor relations team. Please note that today's call is a copyrighted material of Dr. Reddy's and cannot be rebroadcast or attributed in press or media outlets without the company's express written consent.

Before I proceed with the call, I would like to remind everyone that the safe harbor contained in today's press release also pertains to this conference call. Now I hand over the call to Mr. Parag Agarwal. Over to you, sir.

Parag Agarwal
CFO, Dr. Reddy's

Thank you, Amit, and greetings to everyone for the current festive season. This quarter we had strong financial performance with the highest ever sales, PBT and EBITDA in a quarter. The performance has been supported by the launch of lenalidomide capsules in the U.S. and rebound of Russia performance over last quarter. Let me take you through the details for the quarter. For this section, all the amounts are translated into U.S. dollar at a convenient translation rate of INR 81.37, which is the rate as of September 30th, 2022. Consolidated revenue for the quarter stood at INR 6,306 crores, that is $775 million, and grew by 9% year-over-year basis and by 21% on a sequential quarter basis.

In the same quarter of last year, we had high COVID product sales, adjusted for which we have grown in high teens in this quarter. Consolidated gross profit margin for this quarter stood at 69.1%, an increase of 565 basis points over previous year and 920 basis points sequentially. The gross margins were mainly aided by favorable product mix and production linked incentives recognition. However, it was partially offset by provision made on COVID product inventory as the sales from these products have reduced significantly. Gross margins for the global generics and PSAI businesses were at 65.4% and 3.6% respectively for the quarter. PSAI gross margins were primarily impacted due to inventory provision on COVID products and adverse leverage on manufacturing overheads on a lower sales base. We expect it to improve in the coming quarter.

The SG&A expense for the quarter is INR 1,656 crores, that is $204 million, an increase of 4% year-on-year and 7% quarter-on-quarter, which is in line with business growth. As a percentage to sales, our SG&A has been at 26.3%, which is lower by 140 basis points year-on-year and 340 basis points sequentially. The R&D expense for the quarter is INR 487 crores, that is $60 million, and is at 7.7% of sales. We have been making good progress on our R&D pipeline in line with our business strategy. Further, while we continue to drive productivity, we have been investing it back to strengthen our development pipeline, building marketing capability and digitalization.

The net finance expense for the quarter is INR 16 crore, that is $2 million. We have been able to manage well the risk arising from the forex fluctuation in the current volatile environment. The EBITDA for the quarter is INR 1,932 crore, that is $237 million, and the EBITDA margin is strong at 30.6%. Our profit before tax stood at INR 1,611 crore, that is $198 million, which is a growth of 27% year-on-year and a growth of 10% quarter-on-quarter. Effective tax rate for the quarter has been at 30.9% due to the tax effect arising from these additional mix. We expect our normal ETR to be in the range of 25%-26%.

Profit after tax for the quarter stood at INR 1,113 crore, that is $137 million. The corresponding EPS for the quarter is INR 66.89. Operating working capital increased by INR 302 crore, which is $30 million against that on June 30th, 2022. Our working capital days reduced by 15 days due to optimization of inventory across our businesses and factoring of receivables in Russia. Our capital investment during the quarter stood at INR 251 crore, which is $31 million. The free cash flow during this quarter was INR 580 crore, which is $71 million. Consequently, we now have a net cash surplus of INR 1,373 crore. That is $159 million as on September 30th, 2022.

Foreign currency cash flow hedges in the form of derivatives for the U.S. dollar are approximately $402 million, largely hedged around the range of between 78.8 to between 81.7 to the dollar maturing in the next twelve months. Raising ZAR 4,320 million at the rate of between 0.9119 to the rand. AUD 2.4 million at the rate of between 66.04 to Australian dollar. Z AR 67 million at the rate of between 4.82 to South African rand maturing in the next six months. With this, I now request Erez to take you through the key business highlights.

Erez Israeli
CEO, Dr. Reddy's

Thank you, Parag. Good morning and good evening to everyone. I hope you and your loved one are keeping well. I am pleased to take you through the current quarter performance, which is marked by record sales in Divi's and our team. In the last few years, we have built a well-diversified business model, which allows us to have multiple growth drivers and reduce the risk of being dependent on a single market origin. We believe that the current environment of geopolitical and economic uncertainties, inflationary pressure, forex volatility. Our strategy is allowing us to grow. While there may be some fluctuation quarter-on-quarter, we focus on building portfolio pipeline across markets, driving productivity, investing for innovation and taking forward our ESG agenda.

We believe that our strategy, along with the net cash surplus position, will enable us to drive sustainable growth in line with our aspirations. Let me share with you some of the key highlights of the current quarter. We have successful commercialization of volume-limited launch of lenalidomide capsules in the U.S. market. Rebound of Russian sales after they went through channel stock normalization in last quarter. U.S. FDA approval of Stimufend received by our partner, improving visibility on commercialization of our products. Our largest manufacturing facility in Hyderabad, internally referred as FTO-3, has joined Global Lighthouse Network of World Economic Forum. Now let me take you through the key business highlights for the third quarter. Please note that all references to the numbers in these sections are in the respective local currencies.

Our North America generics business recorded sales of $351 million for the quarter, with a strong growth of 38% year-over-year and 53% on a sequential basis. This was largely attributed to the new product launch contribution, including the volume-limited launch of lenalidomide capsules in the U.S. Market. While we wouldn't be able to mention specific sales volume or value arising from the lenalidomide, we expect that these products will continue to contribute meaningfully over the next few quarters as well. The price erosion for the base business has been within the normal trend seen over the last few quarters. In this quarter, we launched seven products and expect this momentum to continue during the balance of the current year.

Our Europe business recorded sales of EUR 52 million this quarter, with a year-to-date growth of 10% and sequential quarter growth of 4%. During the quarter, we launched 10 new products across various countries within Europe. We expect to continue with the growth momentum in the rest of FY 2022. Our emerging market business recorded sales of INR 1,225 crore with a year-on-year decline of 6% and recorded growth of 36%. The year-to-year decline was due to a higher base effect as we had COVID product sales in Q2 of FY 2022. Adjusted for this COVID contribution, we have grown. Within the emerging market segment, the Russia business declined by 2% on a year-to-year basis and grew by 34% on the quarter-to-quarter basis in constant currency.

The sales for Russia have reverted to normal levels after the channel inventory stocking normalized in the last quarter. During the quarter, we launched 31 new products across various countries of emerging markets. We expect this business to continue for the growth momentum during the year. Our India business recorded INR 1,150 crore with a year-over-year growth of 10% and sequential decline of 14%. Adjusted for the COVID product sales during the Q2 FY 2022 and the brand divestment income in Q1 of FY 2023, we have grown in mid-teens year-over-year and mid-single digits sequentially. During the quarter, we launched two new products in India market. As per IQVIA report of June 2022, our MAT rank in value terms is at number 10.

We will continue to reshape our portfolio in India business with focus on one big brand acquisitions, partnerships for focused therapy area, while divesting non-core brands. Our PSAI business recorded sales of INR 81 million, with a year-over-year decline of 29% and sequential decline of 12%. Adjusted for the COVID product sales in Q2 of 2022, the business has declined in single digits over the last year. The decline has been due to lower volume pickup by customers for some of the key products. We expect sales improvement over the next couple of quarters with increasing volume pickup and launch of new products. We have been progressing well in our journey of building a portfolio of complex and differentiated products, biosimilars, and NCE pipeline. We have also made good progress to identify a list of innovation moves for our branded markets.

We continue to actively look for investment opportunities as businesses in line with our strategy. We believe that even in the current uncertain environment, there are multiple opportunities to grow our business, and we are committed to pursue this in line with our strategy. With this, I would like to open the floor for questions and answers.

Operator

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 telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking a question.

Erez Israeli
CEO, Dr. Reddy's

Okay.

Operator

Ladies and gentlemen, we will wait for a moment while the question queue assembles. We have our first question from the line of Tarang Agrawal from Old Bridge Capital. Please go ahead.

Tarang Agrawal
Investment Analyst, Old Bridge Capital

Hi, good evening. Three questions from my side. The first question is on lenalidomide. Just wanted to get a sense that, were the volumes bunched up in the current quarter as per the agreement with the innovator, or should we expect the volumes committed by Dr. Reddy's in the current quarter to probably continue as we proceed? That's number one. Number two, if I look at the cash flow statement for the business, there's roughly INR 600 crore that's been spent on intangibles. So wanted to understand what is the nature of this. Is it purchase of ANDAs or something else? The third question is on the PSAI business.

I believe the gross margins for this business have been declining continuously over the last one year, and they came to a low of about 3.5% this quarter. If you could just explain what's happening there. Is this supposed to move up going forward, or how should we look at it? What is driving this decline, not specifically for this quarter, but over the last three quarters? Thank you.

Erez Israeli
CEO, Dr. Reddy's

Thank you. I will take the first and the third, and Parang will take the second question. On the first, it's absolutely within the scope of the document we have there with the innovator.

Operator

Ladies and gentlemen, we've lost the connection of the line. We request you to stay connected. We'll reconnect them.

Erez Israeli
CEO, Dr. Reddy's

Hi. Can you hear me now?

Operator

Yes. Please go ahead.

Erez Israeli
CEO, Dr. Reddy's

Yes. Can you hear me now, sir?

Amit Agarwal
Head of Investor Relations, Dr. Reddy's

Tarang, you are there?

Operator

Tarang Agrawal.

Tarang Agrawal
Investment Analyst, Old Bridge Capital

Yes, I'm here. I couldn't hear you. Yes.

Erez Israeli
CEO, Dr. Reddy's

Sorry, our line dropped there. Sorry. On the first question on the lenalidomide, the quantities are within the scope of the agreement that we have with the innovator, and we will continue to sell the product also in the next coming quarters. On the third question, indeed the volumes of the API especially on some of the old products went down, and this is the main reason of also the gross margin, as this is a very much a fixed cost type of an industry. What we see that likely the mix will go up, and actually with that also the margins will go up.

Now, over time, strategically, we see growth leader in the PSAI in general in all four levels. One is that is self, mainly driven by certain launches of product in which we will sell commercial quantities for launches that will happen this year, next year, and the year after for those that are pending, including in that. The second is that our CMO business, CDMO business, API, which is also sold under this segment, is going to grow, and we do see a better traction in that direction. Number three are activities that, what we call the indirect business-to-business sale, especially in the Middle East as well as in Japan. We also see, luckily, that increased.

Last but not least, we do have certain ongoing deals with organizations like the Gates Foundation that are supporting the mid- and low-income countries, and we have some interesting projects ahead. Overall, we think that we believe that these three segments will grow also in the future. That may be the second question.

Parag Agarwal
CFO, Dr. Reddy's

Yeah. Tarang, the second question I will take. In the cash flow, the intangible amount that you see is towards the acquisitions that we have announced publicly also in the last couple of quarters. This includes Cidmus from Novartis, also the e-commerce portfolio under development, and we also had another small acquisition payback. It's basically towards the acquisition.

Tarang Agrawal
Investment Analyst, Old Bridge Capital

Okay. Thank you.

Operator

Thank you. We have our next question from the line of Prakash Agarwal from Axis Capital. Please go ahead. Mr. Agarwal, please go ahead with your question.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah.

Operator

We are not able to hear you.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Hello.

Operator

Your voice is breaking, sir.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Am I audible now?

Operator

Yes. Please go ahead.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Thanks, and, thanks for the opportunity. Call quality is not great, so pardon. Hello?

Operator

Yeah. Please go ahead.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Pardon if I'm asking this again, but, two questions. One is, how should we think about the base business performance given there is some competition in your key products? Would it be largely flattish, or it would have come down? And secondly, on the volume-restricted launch that you have done, most or all of it is already booked for the financial year or there is some more?

Operator

Mr. Agarwal, I'm sorry. Your voice is breaking again.

Prakash Agarwal
Deputy Head of Research, Axis Capital

I'll repeat my question.

Parag Agarwal
CFO, Dr. Reddy's

Yeah. I think we have heard the question.

Prakash Agarwal
Deputy Head of Research, Axis Capital

One is the performance on the base business of the U.S. side, how it would have been done. Is it flattish or it would have declined? Second is on the volume-restricted launch that you have done for the generic Revlimid. Is most of it booked or there is more to be booked in the financial year 2023?

Erez Israeli
CEO, Dr. Reddy's

On the second one, we are going to book sales for this product in Q3 and Q4 and in the years to come. It's not that it's one time. We are planning to continue to sell this product to the new program also in the next coming quarters. As for the first question, the best way to describe it is we are very consistent, meaning that even if you on the long-term basis, and that's something we are very trying to be very consistent with our communication. Our U.S. markets, our U.S. activities is growing in the single digits on the multi-year basis.

While from time to time we have mix-ups and mix-downs in accordance to the competition. This quarter indeed we had competition for some key products like Vascepa and Doxil, Suboxone. Against that we launched products and we're going to launch 25 products. Overall, our U.S. market will continue to grow in the same manner that we discussed in the past, and we will have from time to time products which will contribute more meaningfully for a certain period of time. The answer for that is we are consistent with what we discussed in the previous way.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay. Just to, you know, think that I understood the second part of the question correctly, you said, there is more to come in Q3 and Q4 with respect to Revlimid?

Erez Israeli
CEO, Dr. Reddy's

Yes.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay, perfect. Thank you.

Operator

Thank you. We have our next question from the line of Kunal Dhamesha from Macquarie Capital. Please go ahead.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Hi. Thank you for taking my question. First one on the gross margin. We have kind of improved gross margin by 550 basis points. Can you just quantify various moving pieces here? I think your product mix, PLI approval, FX impact, and then offsetting is the product provision and the price erosion.

Parag Agarwal
CFO, Dr. Reddy's

Yeah, Kunal. Our gross margin for the quarter we have reported at 59%, and it has, as I stated, it is strong because of favorable product mix, including the impact of new product launches. That's clearly something that's pushing it upwards. We have also recognized the benefit of PLI and a few other normal export incentives like DBK, et cetera, during the quarter.

We've also taken a provision of around INR 100 crore for COVID product inventory, as the sales have come down quite a bit, as is known. Overall, there is of course a little bit of cost inflation that's sitting in these numbers. There is some softening we are seeing in solvents, which should have some favorable impact in the second half, but costs still remain at an elevated level. Overall, I would say that, yeah, this is what the growth margin is made of. I would just point out that even if you take out the impact of new product launches during the quarter, our growth margin is within the normal range that we have been consistently talking about, which is somewhere between 51%-54%.

Operator

Mr. Dhamesha.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Yeah. Thank you for that.

Would you be able to share some insight in terms of why our ANDA filing run rate remains low? I think, in FY 2020, we filed around 80 ANDAs. FY 2021 was slightly better at 90, and then FY 2022 around 18. If I look at this year's run rate so far is around four ANDA filings, while our R&D continues to remain strong. Any insight into why our ANDA run rate is gradually slower?

Erez Israeli
CEO, Dr. Reddy's

Yes. It's more of a timing within the year of the submissions. Normally, most of the submissions are done in the second half of the year. You are going to see a pickup of those numbers. As for the overall numbers, we are focusing our R&D as much as possible on differentiated products, on the biosimilars, on products that have bigger potential. We are trying to target not 30 and 40 products per year, but rather maybe a lower number than that, around 20, 25 products per year. But those products with the potential to be first to market, meaningful growth, et cetera.

What you see here is also a combination of timing as well as focus of the R&D across markets, not just for U.S. market. The products that we are developing U.S. market, we are also launching in other markets, especially injectables. Actually the value that can be derived from the R&D should be higher in the future, while those relevant products will be launched in the near future, being global, more complex, more injectable, more biologics.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Okay, thank you.

Operator

Thank you. We have our next question from the line of Damayanti Kerai from HSBC. Please go ahead.

Damayanti Kerai
Research Analyst, HSBC

Hi. Thank you for the opportunity. My question is on India piece. Even after adjusting for COVID base and the sale of some non-core brands, for the quarter, sequential growth rate is around mid-single digits, which is lower than market growth of double digits. How should we see growth moving ahead, and what will be the key drivers? A few years back, you mentioned about growing your India sales by almost 50%, on the base existing at that time. Are you broadly on track to achieve that?

Erez Israeli
CEO, Dr. Reddy's

Yes. We are on track. We are very confident that we are on track. What you see now is a combination of firstly, our more focus. As part of our strategy and, as we've said in previous meetings, we identified certain segments that we want to focus on. For those, to put our resources behind meaningful brands that can grow and sustain for many years, as well as investing in what we call the Horizon 2, which India is going to be a big outlet for that. As part of this, we are divesting brands as well as focusing on brands.

For example, the brands that we acquired recently as well as licensing out, which is in area of diabetes, cardiovascular, and more chronic in nature. We do have some brands which is marginal, and we are fixing those. I'm very confident that this will happen as well. Bottom line, I'm very confident that we are going to stay very solid, and we are reiterating that our goal is to be a top player in India, and we have many possibilities.

Damayanti Kerai
Research Analyst, HSBC

Sure. My second question is on injectables. This has been one of your focus segments. Can you talk a bit about the competition outlook for this segment, given we have seen the competition rising in this segment. How do you see competition scenario building up in injectables over next few years?

Erez Israeli
CEO, Dr. Reddy's

We asked the patent cliff to invite people to invest behind products that will have patent expiration in this time. Naturally, as part of the race to be built by the innovators, there are more and more injectables that will be coming off this patent cliff. Actually, many companies have injectable pipelines and it's likely to increase in the future. We do see the injectable business as a very competitive. We see two advantages and differences in the injectable business that are different from those that there are in the overall. First, the channel is different. It's selling to hospital, it can be sold globally. You can use one file around the world, and you don't need to do a bio study for every continent.

The gross margins are higher. In some of these products, the technological barrier is also higher. Given all of this, we believe that we will see more growth, we will see better margin on a global scale. At the same time, every product will face competitions, and if competition will come, it will be as fierce as any other segments, generic segments, which is likely to be also for injectable.

Damayanti Kerai
Research Analyst, HSBC

Sure. My last question is a clarification on PLI scheme benefit. Is it one-off or you are likely to book it every year, or like in next quarters also?

Parag Agarwal
CFO, Dr. Reddy's

Yeah. This is clearly not a one-off. This is a scheme that, as you know, it's a multi-year scheme, and even within this year it is not a one-off. Of course, the quantum fluctuates from one quarter to another, depending on the sales of the product that qualifies for this scheme.

Damayanti Kerai
Research Analyst, HSBC

Okay, that's helpful. Thank you.

Operator

Thank you. We have our next question from the line of Surya Patra from PhillipCapital. Please go ahead.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Yeah. Thanks for this opportunity, sir. My first question is on the cash flow that we are likely to be generating from Revlimid. In fact, Dr. Reddy's been a kind of consistent generator of free cash flow over INR 1,000 crore kind of annually. If Revlimid, the way that contribution that we are witnessing, it is obviously over INR 1,000 crore kind of per annum contribution that we are definitely likely to see. Given that, your quantitative growth outlook, if you can give some means utilizing this cash flow situation. Obviously your growth can be quantitative and consistent over next few years. Can you give some clarity about what would be your key priorities here going ahead, looking at the kind of strong cash flow generation situation?

Erez Israeli
CEO, Dr. Reddy's

Thank you. Indeed, I agree with you. We are building a very healthy cash flow position.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Yeah.

Erez Israeli
CEO, Dr. Reddy's

Which is likely to get stronger and stronger. The key approach is naturally first the basics. To use it for CapEx, to use it for buying and building the future technologies, and to use it for our working capital. We will naturally have access to credit. The second is to increase development. We are actively looking for deals across all of the geographies to tweak our strategy both from Horizon 1 as well as Horizon 2. We feel also that the geopolitical situation as well as the economic situation create an opportunity for us in that space. We do see opportunities that maybe in the past were in higher valuations.

Likely that we are going to be very busy with this development in the next coming quarters. If things relax, we will consider of course how to distribute maybe for the shareholders. We did not take a decision about this kind of stuff like buyback or dividend. What we can assure that we will have a use for the money. The money will be used for in that order of priorities.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Sure, sure. In fact, whether even the R&D, although there is a kind of significant growth that we are witnessing from Revlimid, but accordingly, the R&D spend has also gone up. That was earlier indicated that way. You think with the kind of a ramp-up in the business, the R&D spend and the investment on the specialty project, all that is likely to go up quite meaningfully?

Erez Israeli
CEO, Dr. Reddy's

That's why if you recall in the past, we guided that we are comfortable with 25% EBITDA, which in some quarters will be more, some quarters will be less this quarter. Maybe also in other quarters we'll do more. Absolutely this is the idea that this will help us to pay for the R&D, for the Horizon 2 office activities. Knowing our partners and knowing the cash position, that's why we felt very comfortable to commit in June that we can finance Horizon 2 while including the R&D associated with this, including the R&D associated with Horizon 1, while keeping the overall guidance of EBITDA 25% on a non-GAAP basis.

Yes, we believe that we are in a very comfortable position to do both organic and inorganic. Not just because of this product, also from launches.

Other for the other activities which we will do in the next coming years.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Sure, sir. My second question is on the pegfilgrastim, so the biosimilar. How should we see this as an opportunity for us because our partner, Fresenius Kabi, has already got the U.S. FDA approval for that. How influential this product opportunity will be for us? My only key query here is that what is the kind of association that we are having here because it is filed in the name of Fresenius. The manufacturing base is also used from Fresenius Kabi's base only. What is the kind of relationship that we are having for this opportunity?

Erez Israeli
CEO, Dr. Reddy's

This is a residual agreement that we had in the past activities with Merck, the German Merck, which was acquired by Fresenius. The product was developed by us initially and was taken by Fresenius. We are entitled to royalties, meaningful royalties, as part of the launch. Like you said, rightly so, we are not participating in the actual production, but we will share their success once they will sell the product.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Okay. Sure. Just one clarification. You mentioned about the INR 100 crore provision. Is it relating to the PSAI one and this, INR 193 crore of government grant, that is what is the PLI amount? These two clarifications, please.

Parag Agarwal
CFO, Dr. Reddy's

Yeah. The amount of government grants includes PLI and the other export incentives that we receive. It's a total amount. Sorry, what was your first question?

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

INR 100 crore provision, is it relating to the PSAI?

Parag Agarwal
CFO, Dr. Reddy's

Yeah, it is across all businesses. It is for India as well as PSAI and also in emerging markets. It's an aggregate provision across all geographies.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Is it possible to share for PSAI, sir?

Parag Agarwal
CFO, Dr. Reddy's

We don't share business specific numbers.

Because this is a quarter specific one.

Erez Israeli
CEO, Dr. Reddy's

Let's say that it's without recovery the gross margins of the API will absolutely grow.

Parag Agarwal
CFO, Dr. Reddy's

High single digits. I would put it as high single digits.

Yeah. Without adjusting for COVID provision-

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Yeah.

Parag Agarwal
CFO, Dr. Reddy's

The growth margin for PSAI will be within high single digits%.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Sure, sir. Thank you. Wish you all the best.

Operator

Thank you. We have our next question from the line of Rebecca Choong from Bloomberg. Please go ahead. Rebecca, can you please go ahead with your question? Since there is no response, we move on to our next question from the line of Bino Pathiparampil from Elara Capital. Please go ahead.

Bino Pathiparampil
Head of Equity Research, Elara Capital

Hi, good evening and good morning. Just a couple of questions. Just to follow up on this INR 193 crore government grant, what P&L does it belong to? Is it just this quarter or is it related to products sold over the last few quarters?

Parag Agarwal
CFO, Dr. Reddy's

It is part of the production-linked incentive scheme that the Government of India has created. There are certain products that qualify under the scheme, and this incentive pertains to the sales that have been made in the first half of the year. The scheme started from this fiscal year.

Bino Pathiparampil
Head of Equity Research, Elara Capital

Understood. Second, your tax rate is a bit high for the quarter. Has it got something to do with the higher Revlimid profits built in the U.S.? Is it going to be a higher tax rate whenever there is higher contribution from Revlimid profits?

Parag Agarwal
CFO, Dr. Reddy's

As I said, you know, because of the jurisdictional mix, as you know, we are a global company operating in multiple countries. The sales of various products are booked in various geographies depending on where the IP resides and where the value is created. It's entirely driven by the jurisdictional mix, and it includes some impact of new product launches, including Revlimid, lenalidomide.

Bino Pathiparampil
Head of Equity Research, Elara Capital

Got it. Finally, you have guided to BLA for E7777 in this year, in this current year. Are you on track for that?

Parag Agarwal
CFO, Dr. Reddy's

Your voice is not clear. I'm sorry. Can you repeat the question?

Bino Pathiparampil
Head of Equity Research, Elara Capital

The BLA for E7777, your new product, you had guided for 2022. Is that on track?

Parag Agarwal
CFO, Dr. Reddy's

Yes. We are, you know, it has been filed by our partner.

Bino Pathiparampil
Head of Equity Research, Elara Capital

It's already filed. Okay. Okay, great. Thank you.

Operator

Thank you. We have our next question from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead.

Sameer Baisiwala
Professional, Morgan Stanley

Thanks, and a very good evening. Great quarter. Parag, can you just share what was the core EBITDA margins if you were to exclude those one-offs? I mean, versus the 25%, you know, ballpark target that you had.

Parag Agarwal
CFO, Dr. Reddy's

Sameer, first of all, I would not classify this as core. I think the entire business, the results we have reported are core because any new product launch is part of the core, right? I think there are a few moving parts which I talked about, but let me just list them down again. We clearly have an upside because of new product launches, of which, the generic version of Revlimid is obviously a significant component. It has been a successful high-value launch. There is a COVID-related provision that we have made. We have recognized the government grants of INR 193 crore, as we have disclosed. Overall, there is some impact of cost inflation, but I think we have had good cost control.

Overall, I would say that our EBITDA margin of 30% is core. Having said that, I must clarify that what we have been stating very consistently is that we are targeting our aspiration is to deliver 25% EBITDA margin on a sustainable basis in the near to medium term. We remain on track for that target. There will be quarters when you will see higher EBITDA. There will be quarters where you will see lower EBITDA, but we are on track to delivering our aspirations.

Sameer Baisiwala
Professional, Morgan Stanley

Yeah, thanks for this, Parag. It's just that when I did those adjustments based on whatever information that you guys have shared, it looked like, you know, it was more like 20%-21%. I get your point. It's you want to include everything in the business, but if you were to just see what it was pre-launch and now, it seems to be a little on the lower side and hence the question, so. That's fine.

Erez Israeli
CEO, Dr. Reddy's

I believe that comparably the numbers are higher than that.

Sameer Baisiwala
Professional, Morgan Stanley

Okay. Okay, that's fine. Yeah, that's great. Thanks. Also on the working capital side, Parag, there seems to be INR 700 crore negative working capital if I look at receivables and payables. Can you just talk about that? INR 400 crore and INR 300 crore, I think, are the two movements.

Parag Agarwal
CFO, Dr. Reddy's

That movement would be because of the receivables, because of the higher sales. If you see, in this quarter, our sales have crossed INR 6,000 crore and there is a certain credit period. That, that's the impact which is reflecting.

Sameer Baisiwala
Professional, Morgan Stanley

Okay. Largely coming from the U.S.

Parag Agarwal
CFO, Dr. Reddy's

Yes.

Sameer Baisiwala
Professional, Morgan Stanley

That's the reason why it's a little higher.

Parag Agarwal
CFO, Dr. Reddy's

That's right.

Sameer Baisiwala
Professional, Morgan Stanley

Payables, INR 300 crores, it has gone down.

Parag Agarwal
CFO, Dr. Reddy's

There are certain payments that we have made to our partners. It's not really something which is bringing the payables down permanently. It's just a timing issue.

Sameer Baisiwala
Professional, Morgan Stanley

Okay. Yeah. Just with your permission, the last question. If you look out, next four to six q uarters, anything that you want to highlight in terms of, high value or complex launches for the U.S. market?

Erez Israeli
CEO, Dr. Reddy's

I believe that we'll continue to pursue complex launches.

Sameer Baisiwala
Professional, Morgan Stanley

Okay. When you say that, you mean, you know, with the current basket, you think there'll be more new launches that's going to add on top of this?

Erez Israeli
CEO, Dr. Reddy's

Yes, absolutely. We will launch more products in the U.S. in the second half as well as in the APAC region.

Sameer Baisiwala
Professional, Morgan Stanley

Okay. Great. Thank you so much.

Operator

Thank you. We have our next question from the line of Prakash Agarwal from Axis Capital. Please go ahead.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Hi.

Operator

Mr. Agarwal? Your voice is breaking again.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Am I audible?

Operator

Yes. Please go ahead.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Just a follow-up to my first question asked.

You mentioned there is more to come in Q3 and Q4. Question also was in terms of quantum, have you booked a large amount or expecting, qualitatively, if you can comment that it would be, you know, similar or lesser?

Erez Israeli
CEO, Dr. Reddy's

We cannot guide the numbers. It's going to be meaningful numbers.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay. That is helpful. To understand this further, I understand Natco is gonna come back in March with double-digit volume share. This calendar year or this fiscal year, that is the volume restricted for everybody? Or at least you can comment for yourself.

Erez Israeli
CEO, Dr. Reddy's

We cannot comment on our shares. Our agreement is naturally until 2026. There are certain shares that we own, and we do not want to share. This is a fair settlement with the innovator. Like I said it before, we believe that the quantities and the value can be meaningful also for the coming quarters, including this year.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Fair enough. Just completing the loop here, what I understand is you started in September. You have volume restriction till March, and then there is another increment that happens post-March. Is that right understanding or is it post-September?

Erez Israeli
CEO, Dr. Reddy's

As I mentioned, I cannot specify any details about the settlement.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Mm-hmm.

Erez Israeli
CEO, Dr. Reddy's

It could be in September, in October, in November.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay.

Erez Israeli
CEO, Dr. Reddy's

In December, any month.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay. Fair enough. Okay, that's all from my side. Thank you.

Operator

Thank you. We have our next question from the line of Bino Pathiparampil from Elara Capital. Please go ahead.

Bino Pathiparampil
Head of Equity Research, Elara Capital

Hi. Just a couple of follow-on questions regarding products in the U.S. again. Do you have filings for Lexiscan? I believe there are some inspections going on. Could you give us a little status update? Do you expect to launch it anytime soon, say maybe in the next six, 12, 18 months?

Erez Israeli
CEO, Dr. Reddy's

Binu, I did not pick up the question. Can you repeat?

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Generic version of Lexiscan. You have a filing in the U.S. for that, which is regadenoson. Do you have an update? Do you expect to launch it in the near future?

Erez Israeli
CEO, Dr. Reddy's

Yeah. You know, I think it is. We have a settlement on that. As per the settlement terms, we will have launched in the future. Obviously these settlement terms are confidential, so we cannot discuss launch timings currently.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Understood. Second, there was a guidance regarding rituximab filing in 2023 in the U.S. Is the arrangement with Persimius the same in case of rituximab, the same as Neulasta or do you have a role in there?

Erez Israeli
CEO, Dr. Reddy's

The difference is that, in this case we will make the product and they will market our product. It will be made by us. For all the answers, it will be made by them. This is the main difference.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Okay. Are you on track to file that in 2023?

Erez Israeli
CEO, Dr. Reddy's

We are on track, yes.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Okay. Okay, great. Thank you very much.

Operator

Thank you. Reminder to participants to press star and one to ask a question. We have our next question from the line of Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Thank you for the follow-up. Would you be able to quantify your investment in terms of R&D as well as CapEx for the first half of this year between Horizon 1 and Horizon 2, diversification for our business?

Parag Agarwal
CFO, Dr. Reddy's

Horizon 2, as I had clarified, I think when we had the investor day communication, we expect to invest about 50 basis points-100 basis points of sales in Horizon 2 through our PNL, and we are within that range. At this stage, we are not investing significantly in CapEx for Horizon 2.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

What would be our CapEx for this quarter of around INR 360 crore would be for?

Parag Agarwal
CFO, Dr. Reddy's

The CapEx in this quarter, let me step back. The CapEx for the full year is likely to be around INR 1,500 crores in that range. A lot of this CapEx is towards building capacity for our biosimilars business and for our injectable business.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Okay. Typically, a similar plant, what would be the typical cost, if you can share, or injectable plant?

Parag Agarwal
CFO, Dr. Reddy's

I think it varies. It depends on the product, the complexity, and the current utilization of our current plants. Sometimes it's part of CapEx, sometimes it's higher. I don't think it's possible to give a general answer to that.

Erez Israeli
CEO, Dr. Reddy's

Kunal, when we say CapEx, obviously it is not all going into building new plants. There will be several additions to the existing plant. There will be maintenance CapEx. There will be CapEx on digitalization projects, on R&D facilities. It is all put together. Towards the plant, Parag already clarified those are the two major areas.

Kunal Dhamesha
Pharma and Healthcare Research Analyst, Macquarie Capital

Okay, thank you.

Operator

Thank you. We have our next question from the line of Surya Patra from PhillipCapital. Please go ahead.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Just two questions. On the Revlimid again, please. Do you think there is another wave of generic launches before the twenty-sixth of January, meaning January 2026?

Erez Israeli
CEO, Dr. Reddy's

Well, that is likely that more people will get approved then. I do not know exactly when and what is the next settlement, but likely that before 2026 there will be additional companies approved.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Okay. My second question is on the, let's say, basically India business. Two aspects that I would like to cover. One is the OTC and, second is the, your initiative on the digital kind of effort. Particularly on the OTC side, you have been one of the p layers here in the OTC space of U.S. and Russia since long.

Now you have been trying to build a similar kind of presence in the domestic market in line with your enhanced focus on the domestic business. What is your processes there and what you are trying to achieve there in the domestic OTC space? In terms of profitability, how is it different from the existing ethical business in the domestic market? That is one aspect. Second aspect is that the spends that we have been making on the digital initiative front in the domestic side since last few quarters. How is that, what is the progress there and what is the benefit that we are accruing from that?

Erez Israeli
CEO, Dr. Reddy's

Yeah. Thank you, sir. OTC is indeed important to us, especially in India, and both OTC as well as nutraceutical. Both in going through the, let's call it the traditional channel as well as e-commerce.

What we are trying to achieve, first, we believe if we have and identify, either by ourselves or with partners, products that have a great data behind it. All the products that we launch, whether OTC as well as in prescription, will be backed by scientific data. We believe that this, our brand as Dr. Reddy's as well as the relationship that we have with healthcare professionals can give meaningful value to those brands. Over time these products are also more consumer eventually driven with the recommendation of the professionals, and therefore the business model is more sticky than the generics even in India.

Lastly, profitability once the brand is established is even higher. We also see that because of our position in India, because of our reputation being a reputable vertical company, many partners would like to work with us, and we believe that we can drive value by bringing innovation to India that is done in other countries, and there is a lot of energy in that direction. To summarize that, we are now building a meaningful portfolio with meaningful R&D that is behind it, both internal as well as external, as well as a group of partners that will continue to support it, hopefully for many years. As for the digital, we are continuing to build the business.

We are moving to more cities with our partners, and we will move from.

Mm-hmm.

Actually with our channels, with our partners, working with insurance, working with companies, with our employees as well as direct. It is what we do now is primarily scaling up both the digital capabilities, the service associated with the physicians that are supporting it. We are in more cities with more patients and it is taking a message, which is we do see a great unmet need for outpatient services in India.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Is it going to have a kind of a meaningful implication on the MR productivity also, if not now?

Erez Israeli
CEO, Dr. Reddy's

It's not going to the MR, but you are asking about the MR in the digital, right?

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Yeah, yeah. Yes.

Erez Israeli
CEO, Dr. Reddy's

Yes. The MRs are not relevant here. These are services that we are giving to patients, basically giving them end-to-end solutions without the need. If you wish, it's a service, it's a paid service. It's not selling products.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Okay.

Erez Israeli
CEO, Dr. Reddy's

The MR productivity needs to go up because of the focus that I mentioned before.

By focusing on more meaningful products that will be bigger, more focused with more data behind it, while selling the brands that the relevance that we think of this brand is lower, and this is absolutely will increase the meaningful MR productivity.

Surya Patra
SVP of Healthcare and Specialty Chemical Research, PhillipCapital

Sure, sir. Yes. Thank you. Thanks for your response.

Operator

Thank you. We have our next question from the line of Rebecca Choong from Bloomberg. Please go ahead. Ms. Rebecca, please go ahead with your question. Since there is no response, we'll take our last question from the line of Anubhav from Macro. Please go ahead.

Speaker 12

Hello. Yeah, thanks for taking my question. I have a couple of questions on injectables. With the first part.

Just want to understand, are we seeing any industry-wide challenges in this space in terms of as far as the supply chain challenges are concerned? Because some of the peers have been highlighting for last few quarters in terms of getting the component or raw materials. Wanted to understand, are we also facing.

Erez Israeli
CEO, Dr. Reddy's

It's just.

Speaker 12

If that is the case, are we past that headroom?

Erez Israeli
CEO, Dr. Reddy's

There are naturally dealing with so many products in so many countries.

Speaker 12

Right.

Erez Israeli
CEO, Dr. Reddy's

There are challenges here or there, but nothing significant to report, Anubhav. Nothing that impacts significantly the business. We do not anticipate major disruption as well. As a company, we are a kind of a, let's say, crisis averse in a way that we do not have a single product or a single activity or a single

Speaker 12

Mm-hmm.

Erez Israeli
CEO, Dr. Reddy's

No single supplier or single country that we are dependent on. Yes, there are challenges here and there, but nothing significant.

Speaker 12

Okay. Thanks for this. Secondly, on the long-term strategy for injectables, I understand we are making heavy investment in this space. I want to understand just in that, do we have a goal that whatever injectables we want to get into, we should be manufacturing in-house? Or is it also a possibility that few of the products we can prefer to have, you know, with tie up with contract manufacturers? Because in the past also, I remember there have been couple of products where we did so. Do you see merit in that, or how do you see the strategy as far as injectables manufacturing is concerned?

Erez Israeli
CEO, Dr. Reddy's

The products we are offering in injectables is low down, and we always prefer as much as possible to do it in-house. For that, we qualified the recent generic capacities, and we have now three relatively big facilities in CTO, namely the seven, nine and 11. 11 was qualified recently by the FDA. The business has capacity to go forward. As we don't have access to all the technologies that are related to injectables, on those technologies we will supplement them by inorganic means. Especially those type of products that they just make sense for example to make in India and sell in the United States. For that we have a different solution. If you wish, largely it's going to be organic with some inorganic.

Speaker 12

Okay. That's quite helpful. Thanks a lot.

Operator

Thank you.

Erez Israeli
CEO, Dr. Reddy's

Thank you.

Operator

I would now like to hand the conference over to Mr. Amit Agarwal for closing comments.

Amit Agarwal
Head of Investor Relations, Dr. Reddy's

Thank you all for joining us for today's earnings call.

Operator

Thank you.

Amit Agarwal
Head of Investor Relations, Dr. Reddy's

For any further queries, please reach out to the investor relations team. Thank you.

Operator

Thank you. On behalf of Dr. Reddy's Laboratories Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.

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