Dr. Reddy’s Laboratories - Q3 22/23
January 25, 2023
Transcript
Operator (participant)
Ladies and gentlemen, good day, and welcome to Dr. Reddy's Laboratories Limited Q3 FY 2023 earnings conference call. 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 this 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 Ms. Richa Periwal. Thank you, and over to you, ma'am.
Richa Periwal (Head of Investor Relations and Analytics)
Thank you. A 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 December 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 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 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 rebroadcasted or attributed in press or media outlets without the company's expressed 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. I hand over the call to Mr. Parag Agarwal. Over to you, Parag.
Parag Agarwal (CFO)
Thank you, Richa, and greetings to all and wishing you all a very Happy New Year. I am pleased to take you through our financial performance for the quarter. For this section, all the amounts are translated into US dollar at a convenience translation rate of INR 82.72, which is the rate as of December 30, 2022. This is yet another quarter with a strong all-down financial performance reflected in highest ever sales and profits and strong free cash flow. Consolidated revenue for the quarter stood at INR 6,770 crores, that is $818 million, and grew by 27% year-on-year basis and by 7% on a sequential quarter basis. The performance was supported by healthy growth across our businesses with contributions from both base business and new product launches.
Consolidated gross profit margin for this quarter stood at 59.2%, an increase of 545 basis points over previous year and 15 basis points sequentially. On a year-on-year basis, the gross margins were mainly aided by an increase in contributions from new products and favorable product mix. Gross margin for the global generics and the PSAI business were at 64.6% and 18.2% respectively for the quarter. In line with our expectations, PSAI gross margins have rebounded compared to the last quarter. The SG&A spend for the quarter is INR 1,798 crores, that is $217 million, an increase of 17% year-on-year and 9% quarter-on-quarter. The expense in the current quarter reflects an increase in investments, certain one-off expenses, and an impact of the Forex rate.
As a percentage to sales, our SG&A has been at 26.6%, which is lower by 240 basis points year-on-year and marginally higher by 30 basis points sequentially. The R&D spend for the quarter is INR 482 crores, that is $58 million, and is at 7.1% of sales. We have been making good progress on our R&D pipeline in line with our business strategy. We continue to drive productivity across our businesses while also making investments to strengthen the product pipeline and capability development in marketing, digitalization and people, including for the Horizon Two initiative. The net finance expense for the quarter is INR 14 crores, that is $2 million.
The EBITDA for the quarter is INR 1,966 crores, that is $238 million, and the EBITDA margin is strong at 29%. Our profit before tax stood at INR 1,635 crores, that is $198 million, which is a growth of 68% year-on-year and a growth of 1% quarter-on-quarter. Effective tax rate for the quarter has been at 23.7%. We expect our normal ETR to be in the range of 25%-26%. Profit after tax for the quarter stood at INR 1,247 crores, that is $151 million. Reported EPS for the quarter is INR 74.95. Operating working capital decreased by INR 490 crores, which is $69 million against that of September 30th, 2022.
The decrease is majorly due to higher collection of receivables and some increase in payables. Our capital investment during the quarter stood at INR 292 crores, which is $35 million. We generated healthy free cash flow during the quarter of INR 1,975 crores, which is $239 million. Consequently, we had a net cash surplus of INR 3,401 crores, that is $411 million, as at the end of the quarter. As of 31st December 2022, foreign currency cash flow hedges in the form of derivatives for the US dollar are approximately $351 million, largely hedged around the range of INR 80.3-INR 83.3 to the dollar.
RUB 2,975 million at the rate of INR 0.9661 to the ruble. AUD 1.8 million at the rate of INR 56.20 to Australian dollar, ZAR 34 million at the rate of INR 4.81 to South African rand, maturing in the next 12 months. With this, I now request Erez to take us through the key business highlights.
Erez Israeli (CEO)
Thank you, Parag, and good morning and good evening to everyone. I hope you and your loved one are keeping well. I'm glad to report that I continued with a strong financial performance in the current quarter, as well as with record sales, profit and cash flow generation. We made good progress in our productivity journey, which allow us to remain competitive and grow in our markets. We have been able to identify several new business opportunities, which refer to as Horizon Two business and have started building this. We have also made good progress against most of our ESG goals. Let me share with you some of the key highlights of the current quarter. One, strong revenue and growth driven by continued traction in U.S. and Russia markets.
Second, high cash generation leading to net cash surplus of more than $400 million at the end of the quarter. Three, significant progress made for biosimilars, completion phase III clinical study with Rituximab and completion of phase I clinical studies for Tocilizumab. Let me cover business-wise key highlights in a bit more details. Please note that all the references to the number in these sections are in representative local currencies. Our North America Generics business recorded sales of $375 million for the quarter, with a strong growth of 51% year-over-year and 7% on sequential basis. Sequentially, the sales continued to grow in the U.S. market with a positive traction seen in both base business and recent launches, including Sorafenib, Sapropterin hydrochloride and Lenalidomide capsules.
While contribution from Lenalidomide capsules may fluctuate from quarter to quarter, we're expecting to remain meaningful over the next few quarters. In this quarter, we launched five new products and expect the launch momentum to continue during balance of the year. Our Europe business recorded sales of EUR 51 million this quarter with a year-on-year growth of 8% and sequential quarter decline of 2%. During the quarter, we launched 11 new products across various countries within Europe. We expect to continue with the growth momentum in the rest of FY23. Our emerging market business recorded sales of INR 1,310 crores with a year-on-year growth of 40% and sequential growth of 7%.
Within the emerging market segment, the Russia business grew by 29% on a year-over-year basis and 8% on quarter-over-quarter basis in constant currency. This strong growth was supported by higher sales of biosimilar products in Russia. During the quarter, we launched 29 products across various countries of the emerging markets. We expect this business to continue the growth momentum during the balance of the year. Our India business recorded sales of INR 1,127 crores with a year-over-year growth of 10% and sequential decline of 2%. During the quarter, we launched 2 new products in the Indian markets. We are creating several growth engines for India business for Horizon One and Horizon Two, which includes ramping up internal portfolio, collaborations, innovation and inorganic opportunities.
Our PSAI business recorded sales of INR 95 million with a year-over-year decline of 2%. A strong growth of 18% on sequential quarter basis, contribute by an improvement of the volume pickup. This business is starting to show signs of recovery, and we expect this momentum to continue in the coming quarters as well. We are progressing well on our pipeline products. The number of filings in several of our key markets have been improving. The ANDA and Drug Master Files filings are expected to significantly improve during 2024. We are evaluating several inorganic opportunities across businesses in line with our strategy. We believe all of this will lead to several growth opportunity for us, both in the short term as well as in the long term.
I am confident that we'll be able to continue the growth momentum supported by our strong cash position, focused management team and robust governance and processes. Within this, I would like to open the floor for questions and answers.
Operator (participant)
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 touch-tone 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. Participants, you may press star and one to ask a question. The first question is from the line of Kunal Dhamesha from Macquarie Group. Please go ahead.
Kunal Dhamesha (Research Analyst)
Yeah. Good evening, and congratulations on the great set of numbers. The first question on Revlimid, I think I missed your comment when you said the Revlimid revenue could kind of fluctuate on a quarter-to-quarter basis. Is there any kind of outlook that you are providing for, let's say, quarter four and FY 2024 in terms of the quantum, relative quantum, vis-à-vis Q2 and Q3, what we are seeing?
Erez Israeli (CEO)
We cannot share, as it's part of the agreements that we have. That's what I said. It's what will determine the size of the opportunity is, of course, the timing of the orders that will come from the customers. That may vary from month to month or quarter to quarter. Overall, it's the product will continue to be meaningfully contributing to our business. We are very confident about it.
Kunal Dhamesha (Research Analyst)
Okay. Is it kind of, fair enough to assume that the contribution is expected to increase next year?
Erez Israeli (CEO)
We cannot share guidance in this respect because it's part of the agreement. That's why I'm sharing what I'm able to share at this stage.
Kunal Dhamesha (Research Analyst)
Sure. Second question on, you know, while we have shared that our capital deployment priority is kind of, you know, India followed by other branded markets and, likewise. I think we are generating significant cash flow, and we have not seen any activity on that front. Is there a, you know, basic, timeline, which you are looking at to deploy this cash, or else you are considering any other option, to, you know, about returning this, wealth to shareholders?
Erez Israeli (CEO)
We are engaging in the multiple business opportunities. Naturally, we'll be able to share that when we'll sign the deals. Like we discussed in the past, we knew that this is coming, and we knew the type of capital that we are going to create. For us, it's well within our plans and our strategic plans. The priorities will continue to be similar to what we have discussed in the past. We want to engage it in business development, which is not a shopping spree or big deals, but rather complementary deals that will enable our strategy and create capability or brands that we don't have, or areas in which we can create more meaningful contribution to our both, all stakeholders, customers, shareholders, et cetera.
The second is to continue to invest in both Horizon One and Horizon Two, in CapEx and R&D. That's the use of the money. We believe that we will have a good use for it.
Kunal Dhamesha (Research Analyst)
Sure. I'll join back the queue. Thank you.
Operator (participant)
Thank you very much. Next question is from the line of Damayanti Kerai from HSBC. Please go ahead.
Damayanti Kerai (Research Analyst)
Hi. Thank you for the opportunity. My question is on India business. Although on year-on-basis you have seen good growth, healthy growth, sequentially it has declined. What we have seen in some market databases that Dr. Reddy's growth has been lagging against the broader market growth. How should we see growth outlook for your India piece given it's one of the most important segment for you? What will be key growth drivers from here on?
Erez Israeli (CEO)
The main growth will come from investment in differentiated products and specialty products and collaborations that we are working. We are planning to introduce a lot of innovation in India, and we are building it. In addition to that, we will continue to focus on the brands that we believe can contribute in short term, but much more in the long term. We will continue also to invest in the capabilities to market it in the most productive manner using all the relevant digital tools and and the ability to maximize the return on the investment.
We are going to see also in India continue divestitures of the brands that we are not planning to invest behind, if we believe that the returns that will come from those divestitures will be more than what we will get, if we continue to market it. In that respect, we are well within our strategy. Maybe the results here and there will fluctuate per brand, but overall, I'm very confident that we'll be top five as per the target that we shared with you long back.
Damayanti Kerai (Research Analyst)
Sure. In the acquired Wockhardt portfolio, which you have done, some time back, are the results in line with your initial expectations, or do you think you have further headroom to see better sales for some of the top brands?
Erez Israeli (CEO)
The Wockhardt products sell, they are now selling us very well. I'm very happy with this acquisition. It already exceed our expectations.
Damayanti Kerai (Research Analyst)
My last question is on Russia business. This has been very strong quarter, which you mentioned there were biosimilars which contributed. Should we assume this to be sustainable sales, or this is driven by some one-time pickup, and we might see moderation from here on?
Erez Israeli (CEO)
Russia will continue to do strong, to be strong for us. Quarter-wise, it will fluctuate. This quarter is the timing of the bids with the government on biosimilars, for example. Unlikely that we will see that in the other quarters. It will fluctuate, but overall, we are going to see a in the local currency growth and as related to the protection of the ruble, I think we have a very. Like we proved this year, we have a very good protection on the ruble itself. I'm optimistic from both from even with the scenarios that there will be a significant devaluation of the ruble.
Damayanti Kerai (Research Analyst)
That's helpful. Thank you very much. I'll get back in the queue.
Operator (participant)
Thank you. Next question is from the line of Surya Patra from PhillipCapital. Please go ahead.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Yeah. Thank you, sir. Thanks for the great set of numbers. Just on the Revlimid side, if you could share something more on the kind of visibility in terms of like, it seems that, first two quarters, in the last two quarter, whatever number that we would have generated, it seems that we have already achieved, around 5% or mid-single digit kind of, volume share in the product opportunity. Considering that, is it fair to think that, Q4 and Q1 possibly could be a relatively lower number that we could see from Revlimid?
Erez Israeli (CEO)
I cannot share any numbers about the quarter, so.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Okay. Sir, could you give some sense about, let's say, in terms of the volume share, whatever that you fixed for the first year, how different the volume share number would be for second year?
Erez Israeli (CEO)
I cannot-
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Ballpark indication.
Erez Israeli (CEO)
It's not because I would love to share, but I can't. We have an agreement, and I have to honor the agreement, so please bear with me on that.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Okay. Sure, sir. Sir, the extended question relating to this, that, see the cash flow generation, what we are witnessing, considering that, the near-term priorities, could you share the near-term priorities that you would be having? What I have seen that you have already indicated that you are likely to be or you are likely to remain active in terms of inorganic growth, as well as, the R&D spend also, rate, if I see, it has just moved on along with the kind of, ramp-up in the revenues. Considering these two things, what priorities that would be there for us in the next 12 to 15 months or 18 months period going ahead?
Erez Israeli (CEO)
As we have discussed in the past, our priority is productivity in the short term. It means to grow what we call Horizon One, which is meaning the current business that we have, including investment in those productivity, investment in our portfolio, in the ability to get some of those complex generic faster to the market, some of those biosimilars faster to the market. In Horizon Two, building those new businesses that will give us the growth in the future. We shared in the past. We assume that we will be able to generate enough cash and enough profit to finance for those activities. So far it is going well for us.
The extra cash that we will have, we will use for business development and for investment in capabilities in the business, especially digital organization automation and artificial intelligence. In line of what we have discussed, the broad guidance remain the same. We are comfortable on a long-term basis with the 25% EBITDA and the 25% ROCE, double-digit growth and no debt. This continues to be the guidance that from time to time will be above it, like this year. From time to time will be below it, like some couple of quarters ago. Overall, I think it allow us to, both to be very healthy company and to grow very, very well. We have a potential upside even to exceed these numbers.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Sure.
Erez Israeli (CEO)
So far, we are very much into that. That makes actually for quarter to quarter. If you see our record for the last few years, we are very much where we said we are going to be.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Sure, sir. The revenue, U.S. revenue, excluding Revlimid, if you consider, we have seen this year as a kind of, Although we maintained the revenue run rate excluding Revlimid, there were challenges and a couple of our key product also witnessed competition from others, largely from Indian players only. For this revenue piece, could you give some sense that, okay, next year, what is the visibility that you are having? Are you likely to see the sustained competition and all that impacting the business or some sense about growth that you can indicate for the U.S. business excluding Revlimid?
Erez Israeli (CEO)
Next, in April 2024, we are planning to launch at least 30 products, give or take, and we are planning to continue the growth that we saw in the last couple of years. We indicated that we believe that the baseline of 6%, not 6%, but single-digit growth, 6% was the past. A single-digit growth will likely to happen and maybe more than that. From time to time we'll have a product or products that will create much better growth than that like happened to us in the last couple of months. Those products at a certain point in time also will go down with erosion and other will replace them. Overall the trend is growth.
In addition to that, we believe that once Horizon Two will kick in, also the U.S. will grow in double digits, but this is in a later stage towards, you know, five, six, seven years from now. Now it may fluctuate because of price erosion. It's hard to predict the market share. It's hard to predict. I, unfortunately, I cannot. I don't know what will be quarter-on-quarter, but absolutely we are planning to grow in the United States.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Okay. Is it fair to believe, sir, the next year we will see a kind of a meaningful ramp-up in the kind of a spend towards Horizon Two plans, growth plans versus current year?
Erez Israeli (CEO)
We don't like to ramp up spend. We are planning to spend in accordance, in a very disciplined manner in accordance to our goals. At the time, we indicated that we are going to have more expenses both on the G&A as well as the R&D, but within the ratio of profitability that I mentioned in the past. We will be able with our growth and our cash to finance the investment. It will not be extra and a decrease of the profit.
Surya Patra (SVP of Healthcare and Specialty Chemical Research)
Sure, sir. Okay. Thank you. Wish you all the best.
Operator (participant)
Thank you. Participants you may press star and 1 to ask a question. Next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Prakash Agarwal (Deputy Head of Research)
Yeah, hi. Thanks for the opportunity. Good evening. Just wanted to understand, one is the industry level question. We've been seeing, you know, a lot of U.S. FDA issues going to the next level, and we've been hearing that there's a volume distribution that is happening to the large Indian and global players in the U.S. generic side. Are we seeing that happening to us also? We are getting some volumes for our base business. Would that be correct understanding?
Erez Israeli (CEO)
We do have a growth in volumes. I cannot attribute necessarily for that. The growth that at least we are facing is from activities that we initiated primarily. Naturally we are watching carefully all the results of all the inspections that are happening in India and outside of India. Far for us, knock on wood, all of our plants are operating and in full compliance.
Prakash Agarwal (Deputy Head of Research)
Okay. Okay. With that kind of, you know, volume gain, et cetera, do you think, there's some improvement in pricing on base business or it still remains mid to high single digit for the base portfolio?
Erez Israeli (CEO)
I'm not aware of any, let's say special phenomenon I can indicate both on price or quantities, as related to that.
Prakash Agarwal (Deputy Head of Research)
It remains, similar to exhaustion.
Erez Israeli (CEO)
Maybe marginal, maybe.
Prakash Agarwal (Deputy Head of Research)
Okay. Okay, fair enough. Would it be fair to say that, you know, you know, the incremental growth, you had some approvals and launches for sure, but, with the, you know, the price erosion it nets off and the incremental sales momentum, is coming from this product itself?
Erez Israeli (CEO)
I believe that our growth is coming because we are giving better service to our customers, and they appreciate it.
Prakash Agarwal (Deputy Head of Research)
Okay. Okay. Last one on, you know, the capital allocation. We have seen some companies being successful in late-stage innovator-led programs. Are we thinking about it or, you know, in the past, we had done 505(b)(2) and then we moved to self-sustaining and selling those assets. What is the plan for both these, I mean, if there's any plan on both these strategies?
Erez Israeli (CEO)
We are not planning to come back to the 505(b)(2). We worked hard to get out.
Prakash Agarwal (Deputy Head of Research)
Mm-hmm.
Erez Israeli (CEO)
Horizon Two contains activities that are differentiated by design. We are talking about 11 spaces in India and a couple of spaces outside of India in large market, Europe as well as the United States. We do have NCE as part of our Aurigene Discovery, especially in the area of cancer. We do have activities in cell and gene therapy, in therapeutic management, in OTC, in pharmaceuticals, as well as in other innovation of go-to-market. This is part of the Horizon Two that we share, but not 505(b)(2).
Prakash Agarwal (Deputy Head of Research)
Okay, lovely. Thank you, sir. Thank you and have a good day.
Operator (participant)
Next question is from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead.
Sameer Baisiwala (Analyst)
Hi. Thank you very much, good evening, everyone. First question is on government grant. Looks like in 3Q, you did INR 43 crores and H1, some INR 240 crore odd. I guess your product mix is not changing that much, so what's driving this?
Erez Israeli (CEO)
Obviously, we file the applications as per the government scheme, Sameer, and it depends on the eligibility of the products and the sales that we are making. Depending on the underlying numbers, the grant is recognized. It's obviously something that will continue, but will fluctuate from one quarter to another.
Sameer Baisiwala (Analyst)
Okay. No, fair enough. I get that. Has the product mix, changed so much? The products which were eligible, you didn't do, you know, those sales, in three-.
Erez Israeli (CEO)
Yeah, product mix changes, the sales level of various products also changes. That determines the incentive.
Sameer Baisiwala (Analyst)
Okay. Okay, cool. The second question is on biosimilars. You clearly have focus on that, but if I look at your pipeline, I mean, first of all, good job on Rituximab for phase III, to succeed in this market, you need good five, 10 products, you know, a fairly vibrant, you know, pipeline, you know, several products in phase III type of a situation. Can you talk a bit about it? How will you make a mark in this space?
Erez Israeli (CEO)
If you recall, we decided the time to skip the products that will be with the patent expiration until 2027 because we felt that we'll be late to the market, and we have a pretty robust portfolio for the patent cliff that is after that, even larger number of what you just said. We kept Rituximab as it was already there. We are already selling it in 27 countries. By having the U.S. FDA approved, it will allow us to sell it in many more countries, and we have also agreement with the third party on the U.S. market. Rituximab also will bring the U.S. FDA, and we will be able to approve the relevant sites from a GMP point of view. To your question, we are committed.
We are committed to even larger number of molecules than that. Over time, we are going to see it, and, in accordance to the relevant data, we need to launch the product. We absolutely going to play biosimilars and to be a significant player, especially in emerging markets.
Sameer Baisiwala (Analyst)
Okay. Got it. Got it. One, final one is on Ecosprin. It's been, some time that we are stable at 14%, 15% market share. What's the outlook on this?
Erez Israeli (CEO)
We'll continue to try our best to gain as much market share as possible. It fluctuate in according to decisions of customer.
Sameer Baisiwala (Analyst)
It's not about supply chain or raw material issue?
Erez Israeli (CEO)
No, no. No issues. This was sold, I think a year ago.
Sameer Baisiwala (Analyst)
Okay. Got it. Thank you so much.
Operator (participant)
Thank you. Participants, you may press star and one to ask a question. Next question is from the line of Kunal Dhamesha from Macquarie Group. Please go ahead.
Kunal Dhamesha (Research Analyst)
Yeah. Thank you for the follow-up. I think on the biosimilar products that we are, you know, we have got a good trial data, et cetera, do we have the existing capacity which can support, you know, let's say, fair market share in this product, or will we need to invest more? If yes, would it be the same facility where we would seek expansion, or it could be a greenfield facility?
Erez Israeli (CEO)
We are investing in capacity for the last five years and continuing to invest. You are invited to see our facilities in Vadodara. They are growing on, every year. We have enough capacity to capture, market share globally.
Kunal Dhamesha (Research Analyst)
What would be our current biologics capacity, reactor capacity in total in terms of kiloliters and the gross block related to it?
Erez Israeli (CEO)
I don't remember the kiloliters, but we can produce, let's say, many, many hundreds of kilos each year.
Kunal Dhamesha (Research Analyst)
In terms of our cost structure, would you have benchmarked our cost of production versus, let's say, Korean and Chinese player, and where we stand, you know, versus them?
Erez Israeli (CEO)
We believe that we are very competitive in terms of the cost structure. Part of it is because the technology we are using, part of it is the integration that we have on the product, and part of it is the fact that we are in India and leveraging the economy of India.
Kunal Dhamesha (Research Analyst)
Sure. Thank you.
Operator (participant)
Thank you. Next question is from the line of Prashant Nair from Ambit Capital. Please go ahead.
Prashant Nair (Director)
Yeah. Hi. Thanks for taking my question. My question is on the PSAI business. We've seen a recovery here.
I mean, is it fair to assume that, the disruption in this business is behind us and, you know, there is, you know, this will continue to normalize as we go forward? The second question is on the gross margin side again. This used to be a mid-20% gross margin business, in the past. You know, can it still get to those levels or would it settle a bit lower?
Erez Israeli (CEO)
I believe that it should go there, and we are in the right direction to be there. I also believe that the challenges that we faced in the last 18 months or so are behind us. Like I mentioned, we do see very good signs of recovery. There is still room for improvement also on that side, which I believe that we will achieve.
Prashant Nair (Director)
Yeah. Thank you. That's it for me.
Operator (participant)
Thank you. Next question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Yeah. Thanks, and good evening. Erez, can you update us on China filing and, you know, how the business is doing? When do you expect, you know, meaningful traction in revenues?
Erez Israeli (CEO)
We continue with the process. It's going well. Amit can help me, but I think we are talking about 14.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Yeah.
Erez Israeli (CEO)
the products, now.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Yeah. Every year now, Sayan, we have started filing more than double digits. In double digits, filings have started. As we speak, we have about 20 filings pending approval. In the next few years, going by this run rate, obviously there will be 40, 60 filings over the next three, four years. Typically after filings, it takes 18-24 months for a product to get approved. Last year we got, like, approval for four products. This year we expect similar run rate and going forward even it to become better and better. All I think, statistics are working as we have expected, and the sales also should start picking up faster.
We are already growing in double digits, but that can start growing faster, maybe somewhere H2 of 2024 or 2025 onwards.
H2 of FY-2024.
Erez Israeli (CEO)
Mm-hmm.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay.
Erez Israeli (CEO)
FY2024 we should see growth, FY2025 even more.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Erez also on Russia, I mean, how I mean, I know this quarter is good. You had biosimilar contract. In general, the market dynamics, you know, are you seeing more traction for Indian companies in terms of procurement by the government or market demand in general? I'm just looking at, you know, how should we think about a constant currency growth in Russia from a slightly longer-term perspective, maybe over the next two years.
Erez Israeli (CEO)
I don't see anything special as related to company or country. Everybody in that respect, to my opinion, are waiting to see how events will fall in the country. To the best of my analysis, people did not hit the market as of yet. So it's not a growth that's coming because others are leaving. It's a real growth that's coming from the consumption of people. So the way we are looking at it, as part of our products are OTC, which have seasonality to them. The biologics have a different seasonality that are related to the timing that the government is procuring it. The Rx products are very much having the same demand over the years.
So far it's behaving very normal, to what we see and the growth is attributed primarily to our productivity and not to external events.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Just one last question, if I can. For India, you know, adjusted for the acquisition, Cidmus, et cetera, can you share how the organic growth has been? I think couple of quarters back, you know, you indicated Cidmus to be a big drag on your gross margins. Now, with the, you know, the patent off, how should we think about the situation on that product?
Erez Israeli (CEO)
This product will be profitable for us. The cost structure will be better in the future. The brand is well accepted by the community. It's actually number one in CHF as we speak. We are going to continue to see growth in India in all the places in which we are focusing. Like we indicate, I'm expecting India to continue to be double-digit growth also in the future. On top of it, we will see both inorganic move, investment in collaborations and divestitures. All of these movements will happen in India also in the near future as well as the longer term.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Can you share the growth number adjusted for, you know, acquisition and divestments, just to understand the organic growth in India this quarter?
Parag Agarwal (CFO)
We look at the entire business as a portfolio, so we don't analyze including and excluding acquisitions. I think overall we have reported a growth of 10%. As Erez Israeli said, we are confident that we'll be able to continue to drive growth in India, given being a growth fever. Yeah.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Okay. Thank you.
Operator (participant)
Thank you. Participant, remember press star and one to ask a question. Next question is from the line of Smith from RDA. Please go ahead.
Speaker 13
Thank you for the opportunity. Is Ampyra still meaningful opportunity for us as sales are declining and few companies have already discontinued the product?
Parag Agarwal (CFO)
Sorry, your voice is not clear. Can you repeat the question?
Speaker 13
Is Ampyra still meaningful product for us as sales are declining? Hello?
Parag Agarwal (CFO)
Which product?
Speaker 13
Am I audible? Ampyra.
Erez Israeli (CEO)
The voice is breaking, we cannot get the question. Can you repeat please?
Speaker 13
Is Ampyra still meaningful opportunity for us as sales are declining and few companies have already discontinued the product?
Parag Agarwal (CFO)
Yeah. We have launched this product in U.S., I think in quarter one.
Speaker 13
Mm-hmm.
Parag Agarwal (CFO)
I think there are a significant number of players, if I'm not wrong, about 8-10 players have launched. And the price erosion, I think, has been fairly decent. So we are having a decent sales, but it's not a very large product for us
Speaker 13
Okay. Okay.
Parag Agarwal (CFO)
In terms of market share we are doing good.
Speaker 13
Okay. My other question is on Seldelza.
Parag Agarwal (CFO)
Selumeta?
Speaker 13
Yeah.
Parag Agarwal (CFO)
Selumeta?
Speaker 13
Seldelza.
Operator (participant)
Sorry to interrupt you. Smith, may I request you to speak through the handset, please? Your voice is not coming clear.
Speaker 13
Okay. I will join back to you.
Operator (participant)
Thank you. Next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Prakash Agarwal (Deputy Head of Research)
Just a quick follow-up. Just trying to understand, you know, the smaller strengths where we had exclusivity. When is the competition expected to come for Revlimid?
Parag Agarwal (CFO)
The voice is breaking up. Something is wrong with the line. We can't hear you well.
Operator (participant)
Can you repeat the question, please?
Prakash Agarwal (Deputy Head of Research)
Sure, sir. Am I audible now?
Operator (participant)
Yes, please.
Prakash Agarwal (Deputy Head of Research)
Yeah, I'm just trying to understand, when are we expecting competition on the smaller trends for Revlimid where we have exclusivity?
Erez Israeli (CEO)
We had exclusivity for, 180 days. Therefore, day 181, probably people would come.
Prakash Agarwal (Deputy Head of Research)
Okay. Would that be a decent, a meaningful contributor to the run rate or whatever run rate you are doing on Revlimid sales or these are the small share?
Operator (participant)
Your voice is breaking. Could you just repeat the question again, please?
Prakash Agarwal (Deputy Head of Research)
I'm asking would that be meaningful contribution in the overall sales, Revlimid or U.S. sales, or is it a small share?
Erez Israeli (CEO)
I cannot share the information per SKU. Like I mentioned before, indeed exclusivity will grow in this period of time, and the product will continue to be meaningful to us. Sorry that I cannot share. I understand.
Prakash Agarwal (Deputy Head of Research)
Sure. No, if you can repeat what you said, it will continue to grow.
Erez Israeli (CEO)
It will continue to be meaningful for Dr. Reddy's. That's what I said.
Prakash Agarwal (Deputy Head of Research)
Okay. Lovely. Thank you so much.
Operator (participant)
Thank you. Next question is from the line of Rahul from IIFL Securities. Please go ahead.
Rahul Sanklecha (Analyst)
Hi, sir. Sir, can you provide an update with respect to some of these complex U.S. generic assets, which you had disclosed during your analyst meet last year? When do you expect launches for these complex assets to begin for us in the U.S. market? Given one of your peers recently indicated that market formation has begun for a product, Regadenoson.
Parag Agarwal (CFO)
Yeah. Rahul, we also have approval of this product. I think it is linked to the IP. As it allows us, we have a settlement also with the innovator. As per the settlement terms, we will be able to launch. For your other questions, we are very much on track of what we shared. Also we are planning to launch complex products that was not shared in that meeting. The pipeline of complex product is robust and getting better.
Rahul Sanklecha (Analyst)
Sure, sir. Any timelines which you can share in terms of products like Opioid or Liraglutide or Teriparatide, when do you expect these launches to begin? Would these launches be over the next 12-18 month period or beyond that?
Parag Agarwal (CFO)
Specific timelines we are not sharing, Rahul. Some of these products, we have filed, some of these products are under development. Obviously the launch is linked to both IT scenario as well as we being able to secure the approval. While some of these should start coming, you know, to the market, maybe FY 2025, FY 2026 onwards. That is what we believe. We do not have any firm timelines because all these are linked to both approval and IT.
Rahul Sanklecha (Analyst)
Okay, sir. This mid-single digit growth which you are talking about the U.S. portfolio on an ex Revlimid basis, that essentially will be driven by these 25, 30 launches which you are talking about?
Erez Israeli (CEO)
I know you are putting with and without the product. We are not looking at it in this way. By the time that the dice rolls and will come to this product, it will be naturally part of the base. We are not looking at the market with and without. Absolutely these products that we mentioned will be part of the journey of the growth of in the United States. From time to time, because of the nature of such a product, we will see blips that will be much more than the single digits that we discussed. We are reiterating that we will see a growth on the continuous basis, and from time to time we will see upsets.
Rahul Sanklecha (Analyst)
Sure, sir. Thank you. That's it from my side.
Operator (participant)
Thank you. Next question is on the line of Shyam Srinivasan from Goldman Sachs. Please go ahead.
Shyam Srinivasan (Research Analyst)
Yeah. Thank you for taking my question. Just the first one is on this recent launch by Amazon in the U.S. for this RxPass, right? They have started a subscription-based, you know, $5 per month for the most common, like 60-odd generic medicines. I know it was launched only yesterday across the entire United States. Erez, anything, any early thoughts on, you know, how the supply chain could potentially change, you know, given that if they start making meaningful progress, Is the uninsured or the out-of-pocket population, is it significant, you think? Because it doesn't seem to include Medicaid, Medicare. Just want your initial thoughts just on the industry development.
Erez Israeli (CEO)
Initial thought, it's definitely add a channel that was not there before. It will be impactful, I believe. Over time, whatever is not covered, I believe will be covered, so it's a process that's likely to end. It will make the retail more competitive, and there are both opportunities as well as risks that will come from it to the industry. We also saw this kind of stuff that is happening in other countries. Let's say as initial thought, it's primarily I see it as another channel that we can use.
Shyam Srinivasan (Research Analyst)
Got it. We now know that at least Amazon doesn't directly deal with manufacturers. They probably go through the existing supply chain. Erez, do you foresee or have you seen examples globally where, you know, somebody like that directly deals with manufacturers, or you think, you know, those kind of business models can't evolve?
Erez Israeli (CEO)
I believe that there will be also direct interactions with the manufacturers, yes.
Shyam Srinivasan (Research Analyst)
Got it, sir. Thank you. My second question, just on some of the commentary around the SG&A. In your press release, you talked about one-off expenses in the SG&A, both I think sequentially and year-over-year. What are these and, you know, if you could quantify or qualify, please? Thank you.
Erez Israeli (CEO)
The SG&A is used for either supporting our brands or supporting our capabilities, especially in as related to technology, digital, et cetera, as well as the ability to launch new products. The SG&A will grow as related to both Horizon One and Horizon Two, but there will be more growth that will come from the sales that will support it. I see that's why I kind of say, said that it's all about the margins and That's why I reiterated we are still committed to the same margins that we committed in the past.
Shyam Srinivasan (Research Analyst)
Erez, I was just referring to just the one-off expenses. Just the one-off expenses is what I'm wondering what it is.
Parag Agarwal (CFO)
Yeah. Approximately it would be less than 100 basis points of sales, approximately.
Shyam Srinivasan (Research Analyst)
What is it, Parag? What is it for?
Parag Agarwal (CFO)
I don't think we can disclose the nature of this. This is something in the normal course of the business. It's not likely to recur.
Shyam Srinivasan (Research Analyst)
Got it. Yeah. Thank you and all the best. Thank you.
Operator (participant)
Thank you. A reminder to all the participants, you may press star and one to ask the question. The next question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Yeah, yeah. Thanks for the follow-up. Just one clarification, Erez, on the commentary on the U.S. business when you talk about single-digit growth. What I understand is, you know, you have been talking about this even without Revlimid before. Let's say before Revlimid kicked in, you were doing let's say $250 million a quarter or $1 billion a year. Is that the base we should take for next three, four years, you know, to see single-digit growth and there will be volatility around that due to Revlimid? Is that what you meant, or you are saying that on this larger base that you have, you can grow single-digit in the U.S.?
Erez Israeli (CEO)
I believe that we can grow even on the current base.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Just to follow up on, you know, you talking about 30 odd products, launches. You know, how many of them you think would be complex, you know? Is there any improved visibility over the past, you know, year or so based on your FDA interaction that you have more clarity on these launches next year? Basically, if you can give some color on the quality of launches versus this year. Is it going to improve, remain the same? If you can give some color on that.
Erez Israeli (CEO)
If I'm not taking into account Lena, Lenalidomide, the quality of the launches will be better next year. Some of them will be bigger products, some of them smaller. In terms of pipeline of complex products or products that can be very big, this pipeline is going up as we speak, and we are working very hard on it. I believe that we'll have a very, very interesting pipeline in the next three years of complex. I don't know exactly what will be the launch date of each one of them, but it's a, it's a very interesting portfolio.
Saion Mukherjee (Managing Director and Head of India Equity Research)
Okay. Thank you. That's helpful. Thank you.
Operator (participant)
Thank you. I now hand the conference over to Miss Richa Periwal for closing comments.
Richa Periwal (Head of Investor Relations and Analytics)
Thank you, everyone, for joining us today. If you have any follow-up questions, please reach out to the investor relations team. Thank you.
Operator (participant)
Thank you very much. On behalf of Dr. Reddy's Laboratories Limited, that concludes this conference. Thank you for joining us. You may now disconnect your lines. Thank you.