Dr. Reddy's Laboratories Limited (BOM:500124)
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Q4 21/22

May 19, 2022

Operator

Ladies and gentlemen, good day and welcome to the Q4 FY22 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, Head of Investor Relations. Thank you, and over to you, sir.

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

Thank you. Very good morning and good evening to all of you, and thank you for joining us today for the Dr. Reddy's earnings conference call for the quarter and full year ending March 31, 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 a playback and transcript shall be made available on our website soon. All the discussions 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 Mr. G.V. Prasad, our Co-Chairman and Managing Director, Mr. 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. G.V. Prasad. Over to you, sir.

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

Thank you, Amit. Good evening and good morning and welcome to all of you to this earnings call. Fiscal 2022 has been quite a challenging year. It started with the severe wave of COVID in India and ended with heightened geopolitical conflict, inflationary environment, and economic crisis in certain parts of the world. I'm proud that despite all these challenges, our team has delivered very good operational results. Over the last few years, we've been able to grow on a consistent basis, and the key highlights of this year are healthy revenue growth with steady margins, good progress on the productivity journey, some meaningful launches of products across markets, enhanced offering of the much-needed COVID products, and closure of a few significant business development deals.

Our priorities for FY 2023 will be to strengthen our product pipeline across markets, focus on enhancing our quality systems, continue with the productivity agenda, and make value accretive inorganic moves. While we continue to focus and grow our core businesses, we will also invest in creating future growth drivers. Our CEO, Erez, would cover these aspects in some detail. Sustainability is another area we have made significant progress, but there is a lot more to do. We are on a journey to integrate sustainability into our core business strategy and the execution system. We have identified multiple areas where we can work towards improving the environment and the societal benefit. Shortly, we will announce our detailed ESG targets for the long term.

We continue to be driven by our credo of Good Health Can’t Wait, and we keep the interests of our patients first and will continue to serve them in every possible way with utmost urgency and diligence. With this, I hand over the call to Parag for taking you through the financial performance of your company. Thank you, Prasad, and greetings to everyone. Hope all of you are keeping well. I'm pleased to take you through our results for the quarter four and full year of fiscal 2022. It is yet another year of good financial performance with growth in sales and EBITDA and a strong cash flow generation from operations. While we faced several headwinds during the year, we mitigated these through productivity initiatives and a few one-time opportunities.

Let me take you through the key financial highlights for the quarter and FY 2022 in a bit more detail. For this section, all the amounts are translated into US dollar at a convenience translation rate of 57.87, which is the rate as of March 31, 2022. Consolidated revenues for the quarter stood at INR 45,437 crores, that is $717 million, and grew by 15% on year-on-year basis and by 2% on a sequential quarter basis. The growth has been driven by all markets in our global generics segment and divestment of a few non-core brands. The revenues for the financial year 2022 stood at INR 21,439 crores, that is $2.83 billion, and grew by 13%.

The growth was supported by improvement in the base business volumes and new product launches. Consolidated gross profit margin for this quarter has been 52.9%, a decline of 80 basis points year-on-year and 90 basis points on quater-on-quater basis. While the growth margins benefited from brand divestment income, the decline was primarily attributable to pricing pressure in North America and Europe, combined with the effect of increasing commodity prices. We also had higher provisioning for inventory, including for COVID-related products. Gross margin for the global generics and PSAI business were at 58.2% and 18.4% for the quarter. Gross margin for FY 2022 has been 53.1%, which is a decline of 120 basis points over FY 2021.

Gross margin for the global generics and PSA business were 57.6% and 22.2% for the year. The SG&A spend for the quarter is INR 1,567 crores, that is $207 million, an increase of 9% year-on-year and 2% quarter-on-quarter. During the quarter, we made a provision of INR 98 crores towards an old outstanding litigation with the state of Texas, U.S. Adjusted for this charge, we were in line with normalized level of spend. The SG&A spend for the year is INR 6,208 crores, that is $818 million, and has grown by 14% in line with business growth. The SG&A cost as a percentage to sales was 29.0%, which is largely in line with previous year.

While we will continue to drive productivity, in parallel, we would also invest in markets to strengthen our brand's positioning, expand market reach in various channels and new countries, continue digitalization agenda, and nurture new businesses. The R&D spend for the quarter is INR 433 crore, that is $57 million, and is at 8% of sales. The R&D spend for FY 2022 is INR 1,748 crore, that is $230 million. R&D percentage to sales for the year stood at 8.2%. While we optimize the spend in proprietary products business, we enhance our pipeline and correspondingly the spend for generics, biosimilars and NCE. During the quarter, we took an impairment charge of INR 752 crore, that is $99 million.

The impairments were largely pertaining to, first, product-related and intangible for PPC-06 from proprietary product segment, wherein the market potential has reduced. Secondly, Shreveport subsidiary-related assets, as there has been a substantial reduction in the cash flows of products forming part of the subsidiary. The EBITDA for the quarter is INR 1,298 crores, that is $171 million, and the EBITDA margin is 23.9%. The EBITDA for the year is INR 5,140 crores, that is $677 million. EBITDA margin for the year is at 24.0% and is closely tracking our aspiration target of 25%.

Our profit before tax for the quarter stood at INR 248 crores, that is $33 million, and that for the year stood at INR 3,230 crores, that is $426 million. Adjusted for the impairment and the Texas litigation charges, our profit before tax for the quarter grew by 37% and for the year by 17%. Effective tax rate for the quarter has been at 64.8%, and that for the year has been at 27.0%. The ETR was higher due to an impact of impairment charges taken. We expect our normal ETR to be in the range of 24%-26%.

Profit after tax for the quarter stood at INR 88 crore, that is $12 million, and that for the year stood at INR 2,367 crore, that is $311 million. Reported EPS for the quarter is INR 5.26, and that for the year is INR 141.69. Operating working capital increased by INR 444 crore, which is $69 million, against that on December 31, 2021, mainly driven by increase in receivables and inventory. Our capital investment stood at INR 374 crore, which is $49 million in this quarter, and INR 1,466 crore, which is $193 million during the year. The free cash flow generated during this quarter was at INR 482 crore, which is $64 million.

The free cash flow generated during this year was at INR 1,157 crores, which is $152 million. Consequently, we now have a net surplus cash of INR 1,545 crores, that is $204 million as on March 31, 2022. Foreign currency cash flow hedges in the form of derivatives for the US dollar are approximately $342 million, largely hedged around the range of INR 76.5-INR 79.4 to the dollar. RUB 9.6 billion at the rate of INR 0.9299 to the ruble. AUD 4.4 million at the rate of INR 55.38 to the Australian dollar.

South African rand ZAR 122 million at the rate of INR 4.83 to South African rand, maturing in the next 12 months. With this, I now request Erez Israeli to take you through the key business highlights.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Thank you, Parag. Good morning and good evening to everyone. As Parag highlighted, the FY 2022 has been quite a challenging year, yet it is been fulfilling. We rose to the challenges and have been able to deliver a steady and sustained performance. We have revisited our strategy to cater to the new opportunities and mitigate risk. Our financial strength of strong balance sheet creates an opportunity for us to grow in the current business environment. Let me take you to some of the key highlights of the year. One is strong growth across branded markets of India and emerging markets. Steady growth across generics markets. We regained milestone revenue of $1 billion in North America generics. Improved market share in most of our major markets. EBITDA and ROC in the range of our aspirational targets.

Generation of strong free cash flow leading to a net surplus of more than $200 million. Entered high growth space of medical cannabis business in Germany through acquisition of Nimbus Health, exclusive collaboration with Novartis for in-licensing of key brands in India market, and significant progress made in our digitalization and sustainability journey. Additionally, we continue to focus on productivity while simultaneously making investments to strengthen our pipelines and capabilities. While our core business of generic and NPI will continue to drive growth in the near and midterm, that is what we call Horizon One, we are encouraged to witness several incremental opportunities, such as scaling up of our existing small-sized businesses and creation of new business models for a long-term growth. That is, for us, Horizon Two.

Our financial strength allow us to grow and invest for both Horizon One and Horizon Two businesses. Now, let me take you through the key business highlights for the Q4 and as well as the full year of 2022. Please note that all reference to these numbers in this section are in respective local currencies. Our North America generic business recorded sales of $465 million for the quarter, with a strong growth of 11% YoY and 7% on sequential basis. On a full year basis, we recorded sales of $1,003 million, with a growth of 6% over the previous years. This growth was largely led by key new product launches such as icosapent, Eplerenone , and vasopressin for injection.

We were able to also to grow market share for many of our existing products, which helped to partially mitigate the impact of the price erosion. We launched three new products during the quarter and overall 17 products during the year. We expect the launch momentum to further improve in FY 2023. Our Euro business recorded sales of EUR 53 million this quarter, with a strong year-on-year growth of 17% and sequential quarter growth of 11%. On a full year basis, the sales were EUR 192 million and has grown by 8%, driven by new product launches. During the quarter, we launched 4 products in Germany, 2 products each in Italy and Spain, and 1 each in UK and France. During the full year, we had 34 new launches across our market in Europe.

We expect this strong launch momentum to continue in FY 2023. Our emerging market business recorded sales of INR 1,201 crore with a YoY growth of 36% and a sequential quarter growth of 4%. On a full year basis, emerging market sales has been INR 4,567 crore and grew by 30%. We launched 16 new products during the quarter and 86 new products during the year across various countries of the emerging markets. Within the emerging market segment, the Russia business in quarter four grew by 87% on a YoY basis and 62% on a quarter-to-quarter basis in constant currency. In FY 2022, Russia business grew by 38% in constant currency.

This strong performance in Russia was partially led by divestment income of two brands and higher Q4 sales on account of stocking up, which we expect to normalize during the coming quarter. The current war situation in Russia and Ukraine raised several business uncertainties and significant fluctuation in the currency rates. We have managed the situation very well and ensure the safety of our employees, continuity of the business operation, and financially securing the near term with effective hedging. Our India business recorded sales of INR 969 crore with a YoY growth of 15% and sequential decline of 6%. On a full year basis, our sales was INR 4,196 crore with a strong growth of 26%. During the quarter, we launched eight new products in the Indian market.

As per the IQVIA report of March 2022, we are ranked number 11 on a monthly basis. India remains our priority market, and we are committed to continue to grow this business at healthy rates. Our PSAI business recorded sales of $100 million with a year-on-year decline of 8% and sequential growth of 3%. On a full year basis, the sales were $411 million with a decline of 5%. During the year, there was destocking in the channel customer stocking level after the restrictions in FY 2021. We believe that the customer stock level are now back to pre-COVID level, and we should witness steadier growth in the business in FY 2023.

On the R&D front, our focus has been on building a global pipeline of value-assertive products, including several generics, injectables and biosimilars. We are also selectively investing in a few NCE product candidates. While the number of products filing in the current year has been slightly lower, however we are on track to accelerate this in April 2023. Additionally, we are prepared to leverage our balance sheet strength to invest in value-assertive inorganic moves. I would like to remind that there are several factors which have an impact on the short-term performance of the company, including evolving geopolitical situation and higher commodity price. However, I'm confident that we will emerge stronger with every challenge. We do see opportunities in the current situation and are readjusting our strategy to cater to the new opportunities for future growth.

In the coming months, we'll be holding our investor day and take you through the growth leaders for Horizon One, Horizon Two, and our approach and goals toward ESG. 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 the 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. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Ankush from Axis Securities. Please go ahead.

Ankush Agarwal
Analyst, Axis Securities

Hello. My question is that about the US business. How much of the sales is contributed by the new launches for FY 2022 and last year?

Erez Israeli
CEO, Dr. Reddy's Laboratories

The growth is attributed by two factors. One, our new products, and I noted two of them, Icosapent and vasopressin, as well as a growth in market share of existing products. Both of them contribute significantly to the growth.

Ankush Agarwal
Analyst, Axis Securities

Can I say that it's $1,000 million sales in the U.S. market for the full year that the new launches has contributed, how much sales new launches has contributed, if you quantify, sir. How many new products that we are looking to launch next year?

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

Overall, as you know, the price erosion in the U.S. business is in double digits, and that's more than offset by the new product launches and the share gains. I can, without disclosing any specific numbers, confirm that the new product launches would contribute in double digits to the overall revenue.

Ankush Agarwal
Analyst, Axis Securities

Thank you. Sir, how many new products that we are looking to launch next year?

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

The momentum will continue. This year, as you know, in North America, we launched 17 products. We expect to launch about 20 to 25 new products in FY 2023.

Ankush Agarwal
Analyst, Axis Securities

What is the strategy for the Indian market, sir? How we are looking the launch of a new product, specifically, the growth in the Indian market, sir?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We will continue to launch similar numbers of products like this year. At the same time, the main growth in India will come first from the growing of the brands that we are investing behind that will continue to generate the main growth in the markets. Second, the inorganic moves that we already disclose as well as additional moves that we are working on as we speak. In addition to that, we will have a new product that will come as part of the pipeline, which will have similar numbers that we had this year. In addition to that, this is what we called Horizon One.

As part of Horizon Two, we are going to have additional moves in the area that we will disclose more during the investor day, but this will be in the area of activity that we have such as, which is our outpatient initiative, as well in the areas of nutrition, biologics, activities and digital. Overall, India is a major market for us and will continue to be a focus market for us for many years to come.

Ankush Agarwal
Analyst, Axis Securities

Thank you, sir. Thanks so much. Thank you.

Operator

Thank you. The next question is from the line of Kunal Dhamesha from Macquarie. Please go ahead.

Kunal Dhamesha
Analyst-Equity, Macquarie Capital Securities

Hi. Congratulations on the good set of numbers, and thanks for taking my question. The first question is related to the COVID contribution for FY 2022. If you can give a broader, you know, idea what contribution in terms of revenue was from the COVID or related products, especially on India side and emerging market side.

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

The contribution, as you know, both India and emerging markets have grown this year in strong double digits. A good amount of this growth came from COVID, but even after excluding the impact of COVID portfolio, both these markets still recorded double-digit growth. Overall, I would say for the company as a whole, the contribution of COVID product sales overall is less than 4%.

Kunal Dhamesha
Analyst-Equity, Macquarie Capital Securities

Sure. For the India market, barring the inorganic activity, which is when it happens, what is our organic growth target for FY 2023? You know, if you can just broadly give the growth drivers in terms of pricing, volume and I think new products we are already aware, but would pricing be a very significant driver for us this year?

Erez Israeli
CEO, Dr. Reddy's Laboratories

As you know, we are not guiding in that level of detail. We are expecting India to continue to grow organically in double digits in next year.

Kunal Dhamesha
Analyst-Equity, Macquarie Capital Securities

Okay. Thank you. Second question is on the capital expenditure for FY 2023. This year we had some good amount of CapEx, I think, for the European facility. What would be the guidance for FY 2023?

Erez Israeli
CEO, Dr. Reddy's Laboratories

For FY 2023, we expect the capital expenditure overall to be at similar levels, around somewhere between INR 1,500-1,700 crores.

Kunal Dhamesha
Analyst-Equity, Macquarie Capital Securities

I believe that would mean some additional facilities, so for which geography and for which, you know, injectable or oral solids, which kind of, you know, dosage form we are looking at?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We are not anticipating the need for additional facility. The investment is primarily in the facilities that we have. FTO 11, which are coming up, injectable facilities that we are investing in it, actually quite a lot in the last couple of years will be one place of that the CapEx will grow as well as in our biologics and the digital. This will be the main focus of the investment.

Kunal Dhamesha
Analyst-Equity, Macquarie Capital Securities

Okay, sure. Looking forward for the investor day. Thank you.

Operator

Thank you. The next question is from the line of Neha Manpuria from Bank of America. Please go ahead.

Neha Manpuria
Analyst, Bank of America

Thank you for taking my question. It is on the emerging market business. One, if I were to look at emerging market ex-Russia and Ukraine, that seems to have come off significantly for what we were doing, you know, in the first three quarters. I understand there's some amount of COVID contribution. Is it fair to assume that, you know, the run rate that you have done in this quarter is the base on which we will grow? Or is there any one-off or deferment of shipment that we should keep in mind?

Erez Israeli
CEO, Dr. Reddy's Laboratories

No, no one-offs in those markets. These markets are growing very, very well and will continue to grow in that level. Just, if you recall, we discussed that, the part of the strategy is to take our portfolio globally.

Neha Manpuria
Analyst, Bank of America

Mm-hmm.

Erez Israeli
CEO, Dr. Reddy's Laboratories

EM is actually doing it well, especially on the injectable side. The EM will continue to grow, including smaller markets, based on the leverage of that portfolio as well as local brands, but primarily the leverage.

Neha Manpuria
Analyst, Bank of America

Understood.

Erez Israeli
CEO, Dr. Reddy's Laboratories

It will be the nice contributors to the growth.

Neha Manpuria
Analyst, Bank of America

On Russia, you know, in normalizing for the stocking up that we would have seen in the quarter in the recent weeks, have we seen any change in the demand patterns there or, you know, sales there that you would like to highlight? Or should we assume that Russia would remain on the double-digit growth path that we have seen in the last year?

Erez Israeli
CEO, Dr. Reddy's Laboratories

I believe that we will see some normalization of what we discussed. Overall, we believe that Russia is an opportunity, especially as some of the players will not invest in marketing their products over time. We will continue to operate business as usual. What we don't know, of course, is what will be the impact on the overall economy of Russia. This is, of course, something that we have to be seen.

Neha Manpuria
Analyst, Bank of America

Fair enough. My last question is on margins. If I were to adjust all the one-offs we did about, you know, 21% margin in the quarter, I understand there is Revlimid that is coming, you know, generic Revlimid that is coming through. Core margins excluding Revlimid, is this the base? Given the investments that we have planned, do you think, you know, margin expansion from here would be tough ex Revlimid?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We believe that the number is higher than the number that you mentioned.

Neha Manpuria
Analyst, Bank of America

Mm-hmm.

Erez Israeli
CEO, Dr. Reddy's Laboratories

At least the way I see it is actually 24%. We believe that we want to stay in the neighborhood of the guidance that we gave in the past. We are comfortable with the 25, and we will give or take being that area, as we want to take whatever additional resources we have for investment in the future. We are maintaining our ability, and we believe that we can, for both maintaining this level of profitability as well as to invest in the future, especially now, considering our agenda.

Neha Manpuria
Analyst, Bank of America

Just to, you know, clarify that, you maintain the level of profitability even without even excluding Revlimid?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We are not guiding with and without, because naturally, first we don't, and second, I wish I knew exactly what will happen. You know that.

Neha Manpuria
Analyst, Bank of America

Sure.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Let's say, in long term, no matter what will be the scenario also Revlimid, we are absolutely aiming for the same levels.

Neha Manpuria
Analyst, Bank of America

Got it. Thank you so much, Erez.

Operator

Thank you. The next question is from the line of Surya Patra from PhillipCapital. Please go ahead.

Surya Patra
Research Analyst, PhillipCapital

Yes. Thanks for this opportunity, sir. The first question is on the cost front.

Despite all the challenges what we have seen, we have managed to deliver a strong gross margins and all that. Going ahead, given do you think any cost challenges that we will be facing incrementally, given the supply shortages that is likely to be seen, given the Chinese lockdown and all that? That is one. Secondly, you have talked about the phase one growth, what we have already seen, and you are designing and devising a phase two kind of a growth phase for Dr. Reddy's with new product launches and you know, specialty offerings and all that. Whether in the phase two, we'll see a kind of a challenging growth phase in the initial period in terms of cost, given the higher expenditure around the development and all that.

Something on the cost front, how would that be really shaping up, and how would that be having impact on the overall margins for Dr. Reddy's?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Like everybody else in the industry, we are facing some increase of cost, whether it's commodity prices as well as in things that are related to logistics, transportations, and stuff like that. It's unfortunately not the first quarter that we see that. It's something that is gradually built up since COVID. We absolutely saw in anticipating situation like that also recently. We were able to mitigate most of it by, first of all, having a very effective supply chain. We are not dependent on any specific territories as or whether it's geography or specific vendors. We are able to maintain the competitive fulfillment.

Our logistics is primarily done by sea and less by air, and this is allowing us to mitigate some of those challenges. We are moving into, over time, to renewable energy. This is mostly a mid to long-term natural initiative, but this is enabling us also to deal with the energy potential future challenges. We may see a certain, let's say, the cost may fluctuate from quarter to quarter, but long term, I believe that we are well set to mitigate those challenges.

Surya Patra
Research Analyst, PhillipCapital

Okay. Thanks, sir. The second question is on the US growth front. See, as you have been continuously mentioning that double-digit kind of price erosion, that is, kind of the norm in the US business front. In the recent past, our trend towards US also has moderated because we are prioritizing the non-US markets for growth. Given that and the continuing price erosion scenario, is it fair to believe that sales of Revlimid, we may see a flattish kind of US performance? Any sense on that, sir? I'm not asking about any guidance, but.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Our U.S. business will grow, and from time to time we'll have launches in addition to the other activities that we do. That's what we also did in the last 11 quarters. I believe that we grew 9 out of the last 11 quarters, and this is before even Revlimid. This is likely to continue. Because of timing of those launches, we may see also fluctuation in the sales in the United States, but overall, I believe that on the annual basis we will grow in United States in the coming years. In addition to that, we are investing in the building platform that are outside of the business model that allow us also to grow long-term in the big space. We want to stay in America.

We believe in America. America will continue to be an important market for us. In the generics segment, likely it will not grow like we will grow outside of the U.S., but other growth drivers that we are now working on will absolutely continue to grow as in America, in the same way that we are growing in other places, long term.

Surya Patra
Research Analyst, PhillipCapital

Okay. Just last one, sir. On the inorganic growth front, when you mentioned about that, are you talking about only inorganic growth within India, or it is even you are open for international activity also? In the areas that, if it is there, then the areas that you would be interested in, if you can just say something there.

Erez Israeli
CEO, Dr. Reddy's Laboratories

We are open to inorganic moves in every one of our businesses. In terms of preference, just India is absolutely a preference. In terms of what kind of development, we prefer product acquisitions and as a complementary move to the spaces that we put as a focus in our strategy. That most of our inorganic activities were around products. We are naturally disclosing those that are relatively big, but we are all the time working to strengthen our portfolio also through inorganic and re-licensing activities. In terms of, we are also preferring not to make a kind of big acquisition, but rather a complementary that will give us the relevant capacity, stuff like that.

We want to remain primarily an organic growth organization.

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

Sure. Thank you. Wish you all the best.

Operator

Thank you. The next question is from the line of Nikhil Mathur from HDFC Mutual Fund. Please go ahead.

Nikhil Mathur
Senior Equity Analyst, HDFC Mutual Fund

Yeah, hi. Good evening, everyone. My first question is around the Russian market. In line with the global sanctions that the West applied on Russia, we came across many media articles in which many global innovator companies, they are either withdrawing from Russian market or they are curtailing their operations there. Have you had any discussions with the procurement ecosystem in the Russian market that this could be a fairly structural and substantial opportunity for Dr. Reddy's given your legacy presence in the market? Obviously, there are challenges currently, but still, I mean, could this emerge as a long-term, say, 2-4-year structural positive for the company?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We do see that as an opportunity for us. We cannot discuss now any specific discussions, but it's absolutely one of the avenues that we are discussing as we speak.

Nikhil Mathur
Senior Equity Analyst, HDFC Mutual Fund

Okay. Second question is on the broader U.S. outlook. Two questions related to the U.S. One is on the opportunity next three years, excluding Revlimid. How do you see the addressable opportunity in terms of brands losing exclusivity next three years versus the preceding three years, period?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Without Revlimid, we do see it in the same way that we saw it this year. We have in addition to that, like parag mentioned, 20-25 new launches, which will not be only as sizable as Revlimid, but will contribute to us. I believe that the price erosion will continue. In that way, I don't think that things will change dramatically for us.

Nikhil Mathur
Senior Equity Analyst, HDFC Mutual Fund

Okay. Got it. One final question related to the U.S. market. Just now in one of the earnings call concluded for one of your peers, this question was asked. I'm just repeating that question again. Progressively quarter-on-quarter, we've seen the margins and the return ratios getting depressed in the U.S. market. Now with the added pressure of cost inflation. Any color can you give as to till what time can this pain continue before rationality kicks in? I mean, in the past we have seen global companies withdrawing, but do you think that even the Indian companies which today are at 100, 200, 20 million dollars kind of a sales base in the U.S., they are also might have to pull out or curtail their ambitions in the U.S. market.

Do you think we have reached that stage that pain has to be somehow mitigated?

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

I will answer this question. I think the U.S. market will always remain price competitive. There's always been pricing pressure. It's not new, and it will not end. It will continue. It depends on how well you choose your portfolio, how well you execute the price, and how competitive you are to continue to establish your presence there. We are taking a number of steps to strengthen our portfolio, lower our costs, improve our market share, and we hope to continue to grow in the U.S.

Erez Israeli
CEO, Dr. Reddy's Laboratories

The U.S. will stay an important market for us. As I mentioned, we want to be stronger in the generic space, but we are also working on moves outside of that area as well.

Nikhil Mathur
Senior Equity Analyst, HDFC Mutual Fund

I think it is. I mean, I kind of understand that. I mean, you have made your strategy quite clear. I was just hoping to get some comments on how do you see the competition reacting to the current state of affairs in the U.S. market. I mean, it's fine. I mean, if you people want to reserve your comment, but.

Erez Israeli
CEO, Dr. Reddy's Laboratories

I believe that it will continue. That's how we see it. We don't see significant change coming up, or a disruption to the current state as is.

Nikhil Mathur
Senior Equity Analyst, HDFC Mutual Fund

Great. Absolutely. That's quite clear. Thanks a lot.

Operator

Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Hi, good evening to all. Couple of questions. First on the COVID-related products, you mentioned this 4% contribution, but is there any write-offs which we might have taken at the inventory level in the full year or the quarter?

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

Inventory provisions related to COVID are. There are some write-offs, but they are not significant overall. The overall inventory levels we are carrying for our COVID products are also not material. We are obviously stocked up adequately to meet any potential demand, but the overall levels are not material.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay. When you say non-material, I would understand it would be under 1%.

G. V. Prasad
Co-Chairman and Managing Director, Dr. Reddy's Laboratories

I wouldn't put a number to it. It is not material in the overall context of our business.

Erez Israeli
CEO, Dr. Reddy's Laboratories

We will not confirm or deny that.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay, sir. Got it. Secondly, on the proprietary business that we have built over years. I understand most of the assets are largely, you know, either out-licensed or a couple of them have been discontinued. So going forward, what is the income stream for this? One is I understand the milestones, but we don't have anything in the channel for future new out-licensing. Would that be correct understanding?

Parag Agarwal
CFO, Dr. Reddy's Laboratories

No. On the specialty side, there's nothing significant out there. There are some single-digit income streams which will continue, single-digit $ million. Beyond that, there's nothing much left.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Because if I'm not wrong, this has contributed significantly in terms of out-licensing, which is, you know, flowed down from gross margin to EBITDA and has contributed significantly at the margins. Correct me if I'm wrong, and if not in future, then, given your commentary on raw material prices and et cetera, cost inflation, this would be an extra margin pressure point for us. Would that be correct?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Let me clarify, maybe. First of all, on specialty, we have two parts. We have those products that we discussed that were in the form of 505(b)(2) for the United States. As you stated, rightly so, most of them were licensed or discontinued. As we speak, we are enjoying certain levels of royalties as well as future milestones that may come. We will enjoy the income of those milestones at the time that it will come, especially on products like Elyxyb and et cetera. We have also activities that are related to NCE.

This is what I mentioned in my script, that we are selectively invest now in certain anti-cancer products as part of our subsidiary of Aurigene Discovery. This is more of a long-term and in-depth frame. We are also licensing and have collaborations with in the United States with partners. We are working both to license those products as well as maybe one day in the future to build ourselves. In terms of contribution to the margin and stuff like that, I think we had indeed fee from licensing in Q2. In Q4, there was no activity as such.

Prakash Agarwal
Deputy Head of Research, Axis Capital

The last point was not clear. What did impact on margins?

Erez Israeli
CEO, Dr. Reddy's Laboratories

I don't know any margin. There was no activity, therefore no impact in the margins.

Prakash Agarwal
Deputy Head of Research, Axis Capital

I'm not sure I got it right, but okay. I also want to

Erez Israeli
CEO, Dr. Reddy's Laboratories

Maybe I did not get your question. What effect on margin and by when? Sorry, sir.

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

Prakash, what Erez mentioned is basically in quarter four, there was no licensing income we have received. The quarter four numbers are without any margin benefit.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Perfect. That run rate is also like the 69 crore is the ongoing proprietary sales. That can continue, correct?

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

Proprietary plus Originator, it is combined sales.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Okay. That can continue, and if there are lumpiness, that might not continue.

Parag Agarwal
CFO, Dr. Reddy's Laboratories

There will be lumpiness. It is not a smooth curve because these are milestone-driven, gain-driven.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Yeah. Okay. Got it. Fair enough. Lastly, sir, on the two good products that you have, Vascepa and vasopressin. These have seen market share inching up, but not to the level that one could have expected. Is there a scale-up issue or we expect or you have already achieved the fair share and we are not able to see in the, you know, the database?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We believe that we have a good share of in this product.

Parag Agarwal
CFO, Dr. Reddy's Laboratories

Yeah. We can't give the granular numbers to you.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Have you achieved the fair share, sir, on Vascepa of 15%, 13%-15%?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We have a very good share on this product.

Prakash Agarwal
Deputy Head of Research, Axis Capital

Since it is a recent launch, vasopressin, this is still under the scale-up phase. Would that be correct understanding?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We have also a good share on this product.

Prakash Agarwal
Deputy Head of Research, Axis Capital

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

Operator

Thank you. The next question is from the line of Saion Mukherjee from Morgan Stanley. Please go ahead.

Saion Mukherjee Pvt Ltd.)
Managing Director and Head of Equity Research, Nomura Financial Advisory and Securities

Hi. Thank you so much, and good evening, everyone. Most of my questions have been asked, but just a couple of them more. One is, what's the current exposure to Ukraine market, and are we holding any receivables over there?

Erez Israeli
CEO, Dr. Reddy's Laboratories

The level of exposure is not material and there is no any material adverse events or significant adverse events that we anticipate in the future.

Saion Mukherjee Pvt Ltd.)
Managing Director and Head of Equity Research, Nomura Financial Advisory and Securities

Okay, great. Yeah. Thank you. Erez, you mentioned couple of times that, for the U.S. market, you are putting in some effort outside of the generic business. Can you elaborate on that? Was it the NCE effort or is it something else?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We will elaborate more in the Investor Day, but we are, as we speak, exploring other channels which are not exposed to the current business model in the United States, of course, high level of price erosion that needs to be mitigated by products. We are exploring and even dealing with opportunities that are not part of that business model.

Saion Mukherjee Pvt Ltd.)
Managing Director and Head of Equity Research, Nomura Financial Advisory and Securities

Okay, great. We will wait for the details. The other question arises from two efforts that you have put in India. One is Sputnik vaccine, and the other is outpatient health online healthcare platform. If you can update us on both of these. Thank you.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Sure. Sure. On Sputnik, the main effort is on Sputnik Light, and we got approval for Sputnik Light as a vaccine and as a booster for Sputnik vaccine. We are now conducting a trial that we will have the result next coming weeks, as a vaccine, for other products, for other vaccines, in India. We hope to obtain approval for that. This will allow us to compete on the entire India market, potentially if we get approval. The second effort that we did on Sputnik is that we repatriate the product to India, so all the activities on Sputnik are now in India. We are not dependent on Russia in any shape and form, for that effort. Sorry, your the second part?

Saion Mukherjee Pvt Ltd.)
Managing Director and Head of Equity Research, Nomura Financial Advisory and Securities

On Svaas.

Erez Israeli
CEO, Dr. Reddy's Laboratories

On SVAAS, we are scaling up. We are adding more and more cities in the network, and it's a scale-up mode. So far it looks very, very promising, but naturally it's an early stage for this initiative. It looks very, very promising, and the service and features so far is positive.

Saion Mukherjee Pvt Ltd.)
Managing Director and Head of Equity Research, Nomura Financial Advisory and Securities

Okay, great. Thank you so much, and we look forward to our listing. Thank you.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Thank you, Saion Mukherjee.

Operator

Thank you. The next question is from the line of Vishal Manchanda from Nirmal Bang. Please go ahead.

Vishal Manchanda
Research Analyst, Nirmal Bang

Thanks for the opportunity. With respect to the two brands that you divested in Russia and CIS, Ciprolet and Levolet, can you share what's their contribution, since these sales from these brands would not recur going forward?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Sorry, contribution? I couldn't catch the question.

Speaker 13

What is the contribution of the brands in Russia?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Levolet and Ciprolet.

Speaker 13

Sale of these brands.

Erez Israeli
CEO, Dr. Reddy's Laboratories

That would be about INR 50 crore-INR 60 crore per annum. Yeah.

Vishal Manchanda
Research Analyst, Nirmal Bang

Okay. Even without these brands coming in, contributing next year, you would grow double digits in these markets?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Yes.

Speaker 13

Yes.

Vishal Manchanda
Research Analyst, Nirmal Bang

Okay. Just one more on Rituximab biosimilar. Two things. One, when do you expect to file that? Second, whether you are trying to do an interchangeability on that?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Rituximab.

Speaker 13

The filing.

Erez Israeli
CEO, Dr. Reddy's Laboratories

We are looking for Rituximab as a potential 2024 event. I'm talking about calendar 2024.

Vishal Manchanda
Research Analyst, Nirmal Bang

Are you attempting an interchangeable on that?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Interchangeability.

Speaker 13

Yes.

Erez Israeli
CEO, Dr. Reddy's Laboratories

Yes, of course.

Vishal Manchanda
Research Analyst, Nirmal Bang

Substitutable, is that right?

Erez Israeli
CEO, Dr. Reddy's Laboratories

This is a biosimilar that should be competitive with the rest of the biosimilars of Rituximab, yes.

Vishal Manchanda
Research Analyst, Nirmal Bang

Okay. Just one more on China. Can you share how many approvals have you got under the Benefit-Risk Framework so far, and how many of those have been commercialized?

Erez Israeli
CEO, Dr. Reddy's Laboratories

We actually filed for 11 products, and we received three approvals during the year. Overall in FY 2023 we are expecting to launch about 7 products.

Vishal Manchanda
Research Analyst, Nirmal Bang

How many, sir?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Seven.

Vishal Manchanda
Research Analyst, Nirmal Bang

Okay, thank you.

Operator

Thank you. The next question is from the line of Nitin Agarwal from DAM Capital. Please go ahead.

Speaker 14

Hi, sir. Thanks for taking my question. My question is one on Voglibose. What opportunities do we see, you know, on this product, given the fact that this molecule has been under some growth pressures in the past?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Which molecule?

Speaker 14

Voglibose that you acquired from Novartis, for the India market.

Erez Israeli
CEO, Dr. Reddy's Laboratories

We see that as an important opportunity for us. First we will repatriate it to our India facility, and we believe that our cost structure will allow us to be competitive. Second, it's an area of focus for us, diabetes as well as cardiovascular. The area of chronic disease segments was always a focus for us, and this is an opportunity to bring a familiar brand to the physicians that we are visiting anyway. We believe that our margins will enable us to even grow this molecule in the future.

Speaker 14

Thanks. Secondly, Parag, you know, in the press release you've called out for the gross margin pressure, some amount of inventory provisions. Can you just give us some sense on what would have been the quantum of these inventory provisions that would have hurt the EBITDA margins this quarter, the gross margin this quarter?

Speaker 15

Overall, I would say the impact on the gross margin is not significant. It will be less than 50 basis points from the inventory provision.

Speaker 14

Okay. Thank you, and that's all.

Operator

Thank you. The next question is from the line of Vinod B from InCred Capital. Please go ahead.

Speaker 16

Hi. Most of my questions were answered. Just to follow up on Russia, could you make a few comments about how the business has changed before the war started and after that, especially in terms of logistics, payment, et cetera. Are you able to get products across easily into Russia? How are you managing the payments mechanism out of Russia, et cetera?

Erez Israeli
CEO, Dr. Reddy's Laboratories

Sure. Let's start with the basics. We are shipping products to Russia, and we are getting money from Russia. The logistics within Russia is similar to what was before. We had to adjust our channels, the airlines or other logistics means to ship to Russia, but we do not see any issues with that. We just have to work on solutions for that. As for the payments and stuff like that, actually we saw no disruption as we speak with Russia. In terms of within the market, we are not aware of anyone that actually left the market. Probably there will be less investments in the market, but we are not aware of anyone that actually left or they changed significantly competitive landscape.

It's probably something that will happen, but as we speak, we do not see it.

Speaker 16

Okay, got it. Thank you.

Operator

Thank you. Ladies and gentlemen, this was the last question for today. I would now like to hand the conference over to Mr. Amit Agarwal for closing comments.

Speaker 15

Thank you everyone for joining us today for the earnings call. In case of any further questions, please get in touch with 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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