Alkem Laboratories Limited (NSE:ALKEM)
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May 4, 2026, 3:30 PM IST
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Q4 21/22

May 13, 2022

Operator

Ladies and gentlemen, good day and welcome to Q4 FY 2022 earnings conference call of Alkem Laboratories hosted by Motilal Oswal Financial Services. As a reminder, all participants' lines will be in 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 a touch-tone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Tushar Manudhane from Motilal Oswal Financial Services. Thank you, and over to you, sir.

Moderator

Welcome to our Q4 FY 2022 earnings call of Alkem Laboratories. From the management side, we have Mr. Sandeep Singh, Managing Director, Mr. Rajesh Dubey, Chief Financial Officer, Mr. Amit Ghare, President, International Business, Mr. Yogesh Kaushal, President, Chronic Division, and Gagan Borana from Investor Relations. Over to you, Gagan, for opening remarks.

Gagan Borana
Head of IR, Alkem Laboratories

Thank you, Tushar. Good evening, everyone, and thank you for joining us today for our Q4 FY 2022 and full year FY 2022 earnings call. Earlier during the day, we have released our financial results and investor presentation, and the same are also posted on our website. Hope you have had a chance to look at it. To discuss the business performance and also going forward, we have on this call the senior management team of Alkem. Before I proceed with this call, I would like to remind everyone that this call is being recorded and the call transcript will be made available on our website as well. I would also like to add that today's discussion may include forward-looking statements and the same must be viewed in conjunction with the risks that our business faces.

After the end of this call, if any of your queries remain unanswered, please feel free to get in touch with me. With this, I would like to hand over the call to Mr. Sandeep Singh to present the key highlights of the quarter and the year gone by and strategy going forward. Over to you, sir.

Sandeep Singh
Managing Director, Alkem Laboratories

Thank you, Gagan. Good afternoon, everyone. Starting with the financial performance for the quarter, revenues from operation grew by 13.3% year-on-year, driven by healthy performance in India business, which registered a year-on-year growth of 16.7%. U.S. business was almost flat year-on-year as we tried to offset the significant pricing pressure through our new product launches. Other international business did well during the quarter with year-on-year growth of 35.3%, with our key markets leading the growth. EBITDA margin for the quarter was 13.6%, impacted by higher raw material prices, increase in freight cost and additional manpower as we expand in new therapies.

During the quarter, we had an exceptional item of INR 50 crore debit on account of fair value of investment and income tax of earlier years, INR 91 crore, due to disallowance of marketing expenses in light of the recent legal announcement, which suppressed our net profit for the quarter. Talking about our India business, it registered a secondary sales growth of about 15% year-on-year during the quarter and about 28% for the full year. This was about 1. 5x the IPM growth. This hard performance was majorly driven by strong volume growth, partially helped by COVID-19 tailwinds in our two therapy areas of anti-infectives, vitamin, minerals, nutrients, pain management and gastrointestinal. Most of our mega brands continue to outperform in their respective markets thereby maintaining their lead positions.

Our chronic portfolio also delivered a market-beating performance for the financial year, growing at almost 2x the market growth rate. Our trade generics business, despite the high base of last year, posted a strong performance. Our recently launched Pulmocare division catering to respiratory segment saw an encouraging start with growth rate higher than the IPM growth rate. Moving on to international business, our U.S. business ended the financial year with sales of $1,018 million, which was down 4% year-on-year. While we had good number of new product launches during the year, some of which had limited competition, but significant pricing pressure completely offset the impact of new product launches. During the year, we filed 14 ANDAs with the U.S. FDA and received 21 approvals.

We now have over 160 ANDAs filed with the U.S. FDA, with nearly half of them yet to be commercialized. Apart from the U.S., our other international markets delivered a robust year-on-year growth of 35% during the year, with healthy performance in the markets of Australia and Chile. Talking about Enzene, our biotech subsidiary, it has been a good year for them with three product launches in India and onboarding of multiple companies for their CDMO services. Also during the year, Enzene signed several out-licensing agreements with some of the leading international companies to develop and commercialize products in key markets across the globe. The company has also started global clinical trials on selected products to launch them in regulated markets starting in 2025.

In terms of regulatory inspections, all our manufacturing facilities supplying to the U.S. are having an EIR as on date. Our manufacturing facility at Indore is awaiting pre-approval inspection by U.S. FDA. With this, I would like to open the floor for Q&A. Thank you.

Operator

Thank you. Thank you very much. We will now begin the question -and -answer session. Anyone who wishes to ask a question may press star and one on their touchtone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from Saion Mukherjee with Nomura. Please go ahead.

Saion Mukherjee
Analyst, Nomura

Yeah, thanks, good evening. I just have one question on, you know, the cost pressure that you have mentioned. So raw material as a percentage of sales increased materially. You had talked about it earlier also. It's on a higher side, so how should we think about, you know, freight and raw material costs going into the next couple of quarters? And, you know, what is driving them and any trend that you would like to highlight at this point? Are things coming down or still are going up from the current levels?

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Saion, Rajesh Dubey here. In fact, in our last earnings call also we discussed on this. Obviously, enhanced cost procurement, whatever we have done, as I said in my last call also, partially it was consumed earlier in quarter three. Mainly, as a consumption and sale of those consumed items, it has happened not completely for this quarter also, but definitely for next quarter it is going to be. One good thing now, this material prices, it has started showing softening trend and that's a good thing happening. Whatever material we have procured, essentially we are going to consume it.

Freight also, as you rightly said, both domestically as well as for our international freight, we can witness sharp increases, particularly in rates, for our international freights. Both this is going to have impact going forward. As we indicated last time also, we have taken so many measures to address this issue because, you rightly said, it's a substantial increase. But we feel, somewhere around 115-170 basis points it will be having impact on our gross margin.

Saion Mukherjee
Analyst, Nomura

Sir, just to be clear, you already have an impact in Q4. On top of it, you think there can be 150, 130 basis points more you think, which we'll see in the subsequent quarters in Q1 and Q2?

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Exactly, Saion, I wanted to communicate that only. In fact, whatever procurement it has happened, partially we consumed in quarter four and, but major portion we are going to consume in quarter one of this year. It will be the initial period of quarter two also.

Sandeep Singh
Managing Director, Alkem Laboratories

Impact compared to last year.

Rajesh Dubey
CFO, Alkem Laboratories

In fact, if you recollect October onward, material prices started showing upward indication. In November and December, it was on its peak. Scarcity or availability was also concerned. We accumulated some higher inventory than most of the pharma company did it. Whatever consumed with high cost material consumed, because wherever sale is happening it will be having impact on gross margin. Same material prices, it has not come to its normal. It has started showing indication coming down.

Sandeep Singh
Managing Director, Alkem Laboratories

Very sorry. If I can say, and please, sir, this 150 basis points is the impact compared to last year in quarter one going forward.

Rajesh Dubey
CFO, Alkem Laboratories

Yes.

Sandeep Singh
Managing Director, Alkem Laboratories

In the year.

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Yes.

Saion Mukherjee
Analyst, Nomura

This is quarter-on-quarter. Year-on-year is what you are indicating.

Rajesh Dubey
CFO, Alkem Laboratories

Year-over-year.

Saion Mukherjee
Analyst, Nomura

Compared to the end of last year.

Rajesh Dubey
CFO, Alkem Laboratories

Yes. Yeah. Yes.

Saion Mukherjee
Analyst, Nomura

Okay. Understood. Just another question, you know, on the international business, especially non-U.S., we are seeing some good traction. If you could throw some light, you mentioned Australia, Chile doing well. What is exactly happening? Why we are seeing this step change this year, and how should we think about this business going forward?

Amit Ghare
President of International Business, Alkem Laboratories

Yeah. Saion, Amit here. Yes, we talked about it in the last couple of calls, and in fact, you were one of the ones who said that you've seen a you know business increase and also regularity. You know, it's not really a change in strategy. It is very much the same market that we've been doing for a few years now. We've not really added anything material. I guess the higher performance is directly proportional to some new launches that we did in these markets. And the price erosion in these markets has not been as high as has been in the U.S. There is regulation of course in every market, but not at the same levels.

Those were the combined things, and now that we've also generated some scale, has resulted into this kind of a growth. We'll continue looking at these markets. We'll continue focusing on them for future. We are obviously hoping that we'll continue doing this performance.

Saion Mukherjee
Analyst, Nomura

You expect double-digit kind of growth to sustain in these markets?

Amit Ghare
President of International Business, Alkem Laboratories

That's correct.

Saion Mukherjee
Analyst, Nomura

Okay. Thank you, and I'll join the queue.

Operator

The next question is from Chirag Talati. Please go ahead.

Chirag Talati
Analyst, Goldman Sachs

Yeah. Thank you for the opportunity. How many products are we selling currently in the U.S. market and how many of these are, you know, yet to reach peak potential?

Amit Ghare
President of International Business, Alkem Laboratories

We currently sell about 85 ANDAs. The only ones where which haven't reached its full potential will probably be about 15. The reason for that is some of those we may not be competitive, so we've not reached the levels that we had expected to reach. Some of them may be recent launches. It takes time, a couple of quarters at least, if not more, before we reach the desired market share levels.

Chirag Talati
Analyst, Goldman Sachs

Understood. Sir, given that we had very poor profitability in the U.S. at a PBT level, you know, before FY 2022 as well, in FY 2022, would it be fair to say that at the PBT level, U.S. is not contributing, probably at losses, at PBT level?

Amit Ghare
President of International Business, Alkem Laboratories

We don't split our profits by market, so I'm not sure, Chirag, where you picked up your question. All I can tell you is, several quarters back, we had clearly guided that we are well beyond the breakeven point for U.S., and we are certainly. We've not slipped back into red.

Chirag Talati
Analyst, Goldman Sachs

At the PBT level, sir.

Amit Ghare
President of International Business, Alkem Laboratories

At the PBT level, that's correct.

Chirag Talati
Analyst, Goldman Sachs

Understood. We are still profitable in the U.S. at PBT.

Amit Ghare
President of International Business, Alkem Laboratories

Very much. U.S. contributes to more than 25% of our revenues. We cannot afford a market with loss at that level.

Chirag Talati
Analyst, Goldman Sachs

Understood, sir. Just one more question, if I can. Can you split the India business into, acute branded chronic and generic for the full year?

Sandeep Singh
Managing Director, Alkem Laboratories

If you split the India bucket, first is 22% is, say, trade generic. Remaining 78%, 85% is acute and 15% is chronic.

Chirag Talati
Analyst, Goldman Sachs

All righty. Thank you, sir.

Operator

Thank you. Next question is from Prakash Agarwal with Axis Capital. Please go ahead.

Prakash Agarwal
Analyst, Axis Capital

Yeah. Hi, good evening. My question is on the India business. I don't know if you already shared, but, given that we are, you know, heading on a strong base of last year, are we giving any guidance on the India growth so that we have clarity?

Sandeep Singh
Managing Director, Alkem Laboratories

Yeah. Yeah, Prakash. I think we maintain what we always said. I think we will have double-digit growth this year in spite of coming on a strong base. If you want me to, like, be specific, sure, Prakash, that will be it.

Prakash Agarwal
Analyst, Axis Capital

The growth, you had a very high growth, especially in the first half , due to, you know, the second wave.

Sandeep Singh
Managing Director, Alkem Laboratories

Correct.

Prakash Agarwal
Analyst, Axis Capital

Acute was very heavy, and we have acute heavy portfolio. How do we plan to have double-digit growth, you know, if you could split volume. I think I understand there will be some pricing gain also.

Sandeep Singh
Managing Director, Alkem Laboratories

Before the split. Yeah, got it, Prakash. Sorry.

Prakash Agarwal
Analyst, Axis Capital

If there's anything else you want to highlight.

Sandeep Singh
Managing Director, Alkem Laboratories

Got it. Before the split of, you know, how the growth would come, I'd just like to add that we have added 500 people in quarter four of last year, you know, to rebalance the portfolio and go for growth. Apart from that, you know, price increase would be higher this year compared to previous year. 6%-7% will be price rise. New introduction will be around 3% and volume growth between 3%-4% to 5. Let's say 3%-5%. That's how the split would be. We feel confident that we will cross double-digit growth this year as well.

Prakash Agarwal
Analyst, Axis Capital

One is, I understand, addition of people, and secondly, which will also lead to some volume growth, and the second lever is the price.

Sandeep Singh
Managing Director, Alkem Laboratories

Price is a big lever this year, yeah. Around 7%.

Prakash Agarwal
Analyst, Axis Capital

Yeah. Got it. With 12%-13% India growth, and you are guiding for a margin cut due to the cost increase. Won't it be, operating leverage should play out because India being more profitable, et cetera. It should flow down to EBITDA also. Is that right?

Sandeep Singh
Managing Director, Alkem Laboratories

No, I think, see, you have to understand that, our input has really gone up, Prakash, and we are kind of investing in biosimilars and things like that. Operating leverage come in, but they'll not offset all the price increases which we have had this year.

Prakash Agarwal
Analyst, Axis Capital

Understood. R&D run rate for the quarter is exceptionally high. Is this quarter-based, given that you are going into this biosimilar et cetera or how should we think about a full year run rate?

Sandeep Singh
Managing Director, Alkem Laboratories

Whatever guidance we have given, we stick to that. From this quarter, I don't think it's exceptionally high. We have guided around 6.4%.

Prakash Agarwal
Analyst, Axis Capital

Okay.

Sandeep Singh
Managing Director, Alkem Laboratories

No. We'll stick to around 5.5%-6% yeah.

Prakash Agarwal
Analyst, Axis Capital

Okay. 7.5%-6%. Last one is on the cash. We are continuing to see good cash generation. In the past you've been very, you know, conservative or conscious of any acquisitions. What is the thought process now on that?

Sandeep Singh
Managing Director, Alkem Laboratories

We continue to be the same. DNA has not changed. We are conservative. We do what we know to do best. No large acquisition plans, Prakash bhai.

Prakash Agarwal
Analyst, Axis Capital

Okay, sir. Thank you.

Operator

Thank you. Next question comes from the line of Rashmi Sancheti with Dolat Capital.

Rashmi Sancheti
Analyst, Dolat Capital

Yeah, thank you for the opportunity. Again, on the gross margin front, can you break it up, like, you know, how much impact was just from the high input cost and also from the U.S. price erosion?

Rajesh Dubey
CFO, Alkem Laboratories

If we talk on, I think Rashmi, you are talking for 2021-22. In 2021-22, right now, in Q4 particularly, RM it has impacted by 1.6-1.7%, and equivalent was impact of cost also. Enhanced material cost.

Rashmi Sancheti
Analyst, Dolat Capital

You're saying 1.6%-1.7% from the high raw mat cost and, equivalent to that at least around 1.7%, from the price erosion?

Rajesh Dubey
CFO, Alkem Laboratories

Yes.

Rashmi Sancheti
Analyst, Dolat Capital

Okay. What is the outlook on the U.S. price erosion at the company level? Are we seeing any normalization? I mean, full year, how much was it and how much are we expecting in FY 2023?

Rajesh Dubey
CFO, Alkem Laboratories

Full year last year, price erosion in U.S. for us, for our portfolio was lower double digits, about 11%-12%.

Rashmi Sancheti
Analyst, Dolat Capital

Okay.

Rajesh Dubey
CFO, Alkem Laboratories

This year we're not expecting to be at that levels. We are expecting it to be in single digits, but higher single digits.

Rashmi Sancheti
Analyst, Dolat Capital

Okay. Sir, on R&D, like you mentioned, that, you know, we would be spending 8.5%-6%. Can you let us know, like, you know, how much would be catering to the U.S. and how much would be catering to the international market or Indian market?

Amit Ghare
President of International Business, Alkem Laboratories

I think 90% is for the U.S., ma'am.

Rashmi Sancheti
Analyst, Dolat Capital

90% is for the U.S. only. Okay. That would be more into biosimilars effort.

Amit Ghare
President of International Business, Alkem Laboratories

No. I mean, not more into biosimilars. Biosimilars have started, like, this year and going forward. No, large part is not into biosimilars. Biosimilars is only a part of it.

Rashmi Sancheti
Analyst, Dolat Capital

My last question, again on India. Sir, in trade generic segment, which therapies, you know, are we focusing? Is it similar to branded generic space? The products are similar or, you know, it's a complete different products, separate segment we are selling it in the trade generic segment?

Amit Ghare
President of International Business, Alkem Laboratories

Trade generics, we are not focusing on therapy. Just by our Indian strength and Asian brand name, we get large portion acute and, semi-chronic and things like that. We're not focusing on therapy areas, ma'am, because it's a different ballgame.

Rashmi Sancheti
Analyst, Dolat Capital

Okay. You mean to say that we are more, again, acutely focused and some parts comes from the chronic.

Amit Ghare
President of International Business, Alkem Laboratories

Yes.

Rashmi Sancheti
Analyst, Dolat Capital

That is what I wanted to know. Okay. Thank you so much. Thanks for the opportunity.

Amit Ghare
President of International Business, Alkem Laboratories

Thank you, ma'am.

Operator

Thank you. Next question comes from the line of Damayanti Kerai with HSBC Securities and Capital Markets India Private Limited. Please go ahead.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Hi. Good evening. Thank you for the opportunity. My first question is again on margin. You mentioned, we hopefully are seeing impact of higher input cost on gross margins and all. Going ahead, how should we look at margin at the EBITDA level for FY 2023?

Rajesh Dubey
CFO, Alkem Laboratories

Whatever hit we are going to have in the gross margin level, I think it is going to pass on to EBITDA also. We estimate somewhere between 150-175 basis points for on a yearly basis. That's our estimate. It's going to continue impacting our EBITDA.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay. Around 150-170 basis points hit on EBITDA level also. On a steady state, what margin we should be looking at, around 21%-22%?

Rajesh Dubey
CFO, Alkem Laboratories

EBITDA margin you are referring?

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Yeah, yeah. I'm saying, here obviously we'll have some impact of this higher input cost, but on a steady level, what should be the EBITDA margin, we should consider?

Rajesh Dubey
CFO, Alkem Laboratories

Okay. This time we have 9.3%. I think hit of 150 basis points here. I think we'll be somewhere close to 18% kind of.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay.

Sandeep Singh
Managing Director, Alkem Laboratories

We stabilize at FY 2023. Thereafter, we look to improve from FY 2024 onwards. Hopefully, you know, environment, inflationary environment, you know, eases off a little bit.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay. Sure. My next question is on EBITDA business. Can you update us on the current MR headcount and what is the productivity level across acute and chronic segments?

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Our total MR count is around 10,000.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Sorry, sir. How much?

Rajesh Dubey
CFO, Alkem Laboratories

10,000.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay.

Rajesh Dubey
CFO, Alkem Laboratories

Total strength, yeah. The strength is around 15% in chronic and rest in acute.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay. How is the productivity levels, sir, in terms of PCPM?

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Broadly, I would say acute is around INR 6 lakhs. Chronic is 3-3.25.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay. My last question will be your thoughts on biosimilar business. How do you see it scaling over the next 3-5 years? What kind of further investments are you looking here?

Sandeep Singh
Managing Director, Alkem Laboratories

This is the first, you know, so I think next years we could. Headquarters in New York, say around INR 250 crore. The big growth will come when we launch it in international regulated markets like U.S. and Europe, and that is still like, 3-4 years away. We have invested already, say INR 700 crore, and every year we might invest another, say, INR 100 crore or Indian things like that.

Damayanti Kerai
Analyst, HSBC Securities and Capital Markets

Okay. Around INR 700 crore kind of investment here you are investing at this point in time. Okay. Thank you. I'll get back to you.

Operator

Thank you. The next question is on the line of Nithya Balasubramanian with Sanford C. Bernstein. Please go ahead.

Nithya Balasubramanian
Analyst, Sanford C. Bernstein

Thank you. On trade generic mapping in the last year alone, we have seen several companies join the fray. Some of them, other large, your peers and other large pharma companies. Given that there is now increased competition, how do you see this impacting your market share and rank? A related question around, is this likely to open up new markets or is it more likely to cannibalize existing branded industries?

Rajesh Dubey
CFO, Alkem Laboratories

See, competitors will enter. As I remember a couple of meetings before our MD answered this, Sandeep Singh, very clearly. See, it's not that simple. You know, generic also has a very strong connect and relationship building with supply chain network, right? From, you know, your production unit till your depots and distribution network stockists. All that takes time. I think that over a period of last year or so, IGM has built a very strong equity on that front. While competitors will come and they will find some way to get some share, but IGM has a very strong presence there. What's the next question?

Nithya Balasubramanian
Analyst, Sanford C. Bernstein

The second one was, as you see more players enter, do you see the market itself expanding or cannibalizing existing generic markets?

Rajesh Dubey
CFO, Alkem Laboratories

Answers are less likely because India still has, you know, a reach of medicine. It's still not beyond 40%-45% population. Any and everyone has a space to create their own market. It won't disturb the current flow of IGM or anyone. Everyone can take a space here.

Nithya Balasubramanian
Analyst, Sanford C. Bernstein

Got it. My next one was actually on the U.S. If you see, if this high single digit kind of price erosion sustains, and based on your outlook for how much new launches could add, what sort of a growth are you envisaging in the immediate next two to three years?

Sandeep Singh
Managing Director, Alkem Laboratories

For the immediate year, we had talked about a double-digit growth, a lower double-digit growth. Sitting only in the second month of the fiscal year, we are very much sticking to that. It's a challenge, but certainly that's the kind of growth that we are estimating. Going forward, obviously we'll continue to look to remain on that growth projection. Our base will increase obviously, so that will bring its own set of challenges. That's what we are looking at. Around 10%-12% is what we are looking at.

Nithya Balasubramanian
Analyst, Sanford C. Bernstein

Thank you so much.

Operator

Thank you. Next question is from the line of Kunal Randeria with Edelweiss. Please go ahead.

Kunal Randeria
Analyst, Edelweiss

Good evening, thanks for giving me the opportunity. Sandeep, can you maybe, you know, share with us what are the volume growth levers the Indian market? Because from the outside, it seems that the three or four biggest categories are around gastro and vitamins. You know, there could be some volume pressure this year. I know because obviously we have phenomenal therapies or brands in your view will be under select.

Sandeep Singh
Managing Director, Alkem Laboratories

Yeah. You know, I mean, I would add anti-infectives to that as well because that also had a high base last year. You know, we will have the volume growth is around 3%-4% or 5% at best. It's not unreachable because we have added people the last few years and we will be getting market share, which we have already always got. Even if you look at our market share of the last year, there has been a 0.3% increase in the market share if you look at us, both Zydus and IPM. I think it's just good aggressive manpower addition we have done. We have entered the respiratory therapy, which is a new area. There itself we see some growth. The new areas for us are opening up.

The chronic segment is not as big as acute, but that's also not small now. There we continue to grow by good double-digit volume. Therefore, we feel confident that those volume levers will work.

Kunal Randeria
Analyst, Edelweiss

Sure. Thanks for this. Second question is on the U.S. business. While I understand you had double-digit price erosion in the U.S. this year, you're also having some interesting launches, you know, Duexis, [inaudible] , and so on. I just want to understand how the U.S. margins have moved in FY 2022, and how do you see the margins moving in FY 2023? Maybe qualitatively you can give some comments.

Amit Ghare
President of International Business, Alkem Laboratories

For now we don't disclose our business segment, margins unfortunately. I won't be able to answer that question. We did answer, you know, several quarters back, several years back actually, and I answered earlier today. We are well beyond the breakeven point many years ago and, you know, we have no intention of going into red.

Kunal Randeria
Analyst, Edelweiss

Sure. Qualitatively, maybe not whether you expect your margins to go up or maybe you don't go down the road, you can go up.

Amit Ghare
President of International Business, Alkem Laboratories

Right. Year-on-year, our margins have remained fairly steady is what I would say. Our trade business has obviously seen a large price erosion last year. Some new launches, exactly the ones that you mentioned and even otherwise, have certainly helped us. Our, you know, new business contribution last year was one of the highest in all the fiscals, because of which we could actually sustain a small degrowth instead of a larger degrowth in the business. The biggest business certainly degrew by a lot because of price erosion, and in some cases even loss of market share. That certainly helped. Going forward, we are hopeful with more contribution coming from new launches. New launches traditionally come at a better margin profile. That certainly will, you know, help us to improve our margins.

Kunal Randeria
Analyst, Edelweiss

Excellent. If I can just squeeze in one more. While I understand that below the COGS line you may not have a lot of room, you know, this year because of the increase in trade cost and all, but in general, maybe over a 2- or 3-year period, you know, what kind of cost, you know, optimization can we expect?

Rajesh Dubey
CFO, Alkem Laboratories

Optimization on.

Sandeep Singh
Managing Director, Alkem Laboratories

The way we want to take things.

Rajesh Dubey
CFO, Alkem Laboratories

I think our margin it is in the range of somewhere between 60%-62% kind of. Yes. This year because of

Sandeep Singh
Managing Director, Alkem Laboratories

Below gross margin.

Rajesh Dubey
CFO, Alkem Laboratories

Below gross margin, I think more or less whatever change we had, we are going to have. Operating leverage is going to flow. There are a few things having inflation impact also, and that is bound to happen. For example, distribution costs, freight. We do have some levers and cost optimization all across India. Wherever we see an opportunity, we are working on that, including manufacturing and other areas, including optimization at our API facilities, distribution, all across. We have some levers, and we have identified those. We'll be working towards it. Otherwise, it is very difficult to have objective of adding to EBITDA margin even though 50-100 basis points.

That's a tough task we have taken, and we'll be working towards it.

Kunal Randeria
Analyst, Edelweiss

Thank you, and all the best.

Operator

Thank you. Next question is from the line of Yash Khanna with [inaudible] . Please go ahead.

Speaker 16

Hello. Am I audible?

Operator

Yes, you are.

Speaker 16

Good evening, team. My first question is, I wanted to understand more on Alkem's long- to medium-term strategy on the chronic side of the business. They've outperformed on the acute side. They have also outperformed on the chronic side. I wanted to understand more on how do we see our chronic business 3-5 years down the line, since competitive intensity might be a little higher on this side. How are we planning to execute consistently on the chronic side?

Rajesh Dubey
CFO, Alkem Laboratories

I think two, three areas which are clearly defined by chronic. One is, you know, our productivity is still average. Compared to within company we are at INR 3 lakhs. We should be looking at how do we compete within the organization and raise the productivity. Because our prescriber base is still, you know, around, at average levels. Even if I double the prescriber base in next 2-4 years, 2-3 years, I should be able to increase our productivity. First is productivity. Second, of course, is, you know, the main therapies which dominate chronic is cardiac and diabetes. On a diabetic front, we have a very strict pipeline of new products and these can be blockbusters. Like, you know, we have launched combinations of glimepiride, vildagliptin.

We are doing very good on dapagliflozin, sitagliptin. All these are molecules which are worth around INR 300-500 crores in, yeah, in 2-3 years' time. Right now we should be around close to INR 1,000 crores in next year, and we look at that around four clear times can we double the base and reach around INR 2,000 crores.

Speaker 16

You said INR 1,000 crore-INR 2,000 crore in 3-4 years' time?

Rajesh Dubey
CFO, Alkem Laboratories

Four years' time.

Speaker 16

Yeah. Okay. Got it. That was helpful. Second was, actually again on the margin. I think before this year, understanding was that we would improve margin by 50 to 100 basis points year-over-year. Now, FY 2023, we've guided for 18%. Post that, should we expect 100 basis points, consistent improvement in the margin for next-

Sandeep Singh
Managing Director, Alkem Laboratories

50 to 100, we said that, yes. You chose the higher end, but we've been saying 50 to 100. Yes.

Speaker 16

Okay. 50%-100% decline this year, I mean, coming year, then we would be going up.

Sandeep Singh
Managing Director, Alkem Laboratories

Hopefully, yes.

Speaker 16

Okay. One more question, if I may. I just wanted to understand, from a medium to long-term timeframe, capital allocation priority, like which geographies or where are we planning to, you know, invest a lot of money?

Sandeep Singh
Managing Director, Alkem Laboratories

I think so in the medium term, shorter medium term, nothing is changing. The geographies are going to be India and U.S. and some key other ROW markets. Where you want to allocate, I think cardiovascular is a new frontier. Nothing other than that right now.

Speaker 16

Okay. Got it. No major CapEx lined up.

Sandeep Singh
Managing Director, Alkem Laboratories

No CapEx. No, no. Thank you.

Operator

Thank you. The next question is from the line of [inaudible] with Nexus Capital. Please go ahead, sir.

Speaker 17

Hi.

Operator

Go ahead, Gino.

Speaker 17

Hello. Sorry. Most of my questions have been answered. Thanks. Just a clarification on tax rates, if you can give some guidance for 2023 and, if not this tax, at least some additional guidance over next three to five years on how the tax rate is likely to move.

Sandeep Singh
Managing Director, Alkem Laboratories

Yeah. For the next two years, as per our estimate, tax is going to be somewhere between 11%-14% kind of. Going forward, I think, since our brands, they will come out of 80IE. This I'm talking for 2026, 2027 onwards. That time we'll give fresh guidance. For the next two years, we'll be in between 11-13 or 14% kind of.

Speaker 17

Facilities are probably coming out of the expansion around 2026, 2027 time frame.

Sandeep Singh
Managing Director, Alkem Laboratories

Sorry, I did not get you.

Rajesh Dubey
CFO, Alkem Laboratories

Coming out of?

Speaker 17

If I heard correctly, the facilities are coming out of the expansion in the 2026-2027 year.

Sandeep Singh
Managing Director, Alkem Laboratories

Yes, yes. You're right.

Speaker 17

Okay. That's great. Thank you.

Operator

Thank you. Next question is from the line of Saion Mukherjee with Nomura. Please go ahead.

Saion Mukherjee
Analyst, Nomura

Thanks for the follow-up. Since one question on, you know, biosimilars, you mentioned INR 100 crore investment every year. This is all operating expenses, I would assume.

Sandeep Singh
Managing Director, Alkem Laboratories

Yes.

Saion Mukherjee
Analyst, Nomura

How much is Enzene currently contributing negatively till the year by around INR 100 crore? Or there are-

Sandeep Singh
Managing Director, Alkem Laboratories

Yeah, round about that much this year. Last year, yes.

Saion Mukherjee
Analyst, Nomura

Okay. What are the key milestones and things we need to sort of watch out for in terms of, you know, clinical studies, etc. This number will remain at INR 100 crore over the next few years, you think, or it can go up also?

Sandeep Singh
Managing Director, Alkem Laboratories

No, I think it can go up. This is just for the next, let's say, couple of years. Yeah, if ambition level goes up, we'll obviously update you all, talk to you all, then this number would be going up. Sorry, what is the question, Saion? Sorry, your first question was?

Saion Mukherjee
Analyst, Nomura

What are the key milestones?

Sandeep Singh
Managing Director, Alkem Laboratories

One of the key milestone is that launching in India. We have launched three products, and we will be launching two more. We have already outsourced some products to European players who have given us good upfront payment. I think that's the milestone. These milestones already happened. Going forward, I think what we need to track is how does the clinical trials progresses in the U.S., which is already initiated from our, the U.S. market. There we need to be on time and, you know, file it on time.

Saion Mukherjee
Analyst, Nomura

This is for the U.S. filing. When have you disclosed the product? If you can give some size and, like, when do you expect the trial to be completed and filing to happen?

Sandeep Singh
Managing Director, Alkem Laboratories

Yeah. I think filing would happen around 2024 end, year 2024 end. Filing would happen around that time. Yes. The molecule, I think we can let you know it's denosumab. Yeah.

Saion Mukherjee
Analyst, Nomura

The other question I had on field force. I think you mentioned about 500 people added the last quarter. If I remember historically, you have added, like, 1,000, 1,200 every year. This is very high. Are we sort of stepping up, you know, MR addition going forward? If that's not the case, is there any strategic rationale for doing that?

Sandeep Singh
Managing Director, Alkem Laboratories

No. We are not stepping up. I think we have already added. Hopefully, there's always strategic rationale to it. I think, see, it's the portfolio alignment and how do you make large brands focus and grow and also give space to medium-sized brands to grow. That's the reason we have done this, Saion.

Saion Mukherjee
Analyst, Nomura

I mean, your addition would remain on an average 1,000-1,200 every year.

Sandeep Singh
Managing Director, Alkem Laboratories

No, no. We cannot do it like perpetually. You know, we'll reach 100,000. Of course we can't do that. But we, you know, we also cognizant of the fact that we do have a lot of people. But at the same time, we have to do it because it is important. It is very strategic. You know, the product portfolio is still around, let's say, 1/3 of acute. We don't see a dip being like that much, even close to that number for the next two years every year. I think we are almost saturated. But yeah, if there's a strategic cause, we might add 200, 300 people in the next few years.

Saion Mukherjee
Analyst, Nomura

Okay. Understood. Just one question on, you know, acquisitions in India. You have restrained from, you know, doing deals in India. Given the kind of base you have, don't you think, you know, Alkem can add value by acquiring brands even if it is somewhat expensive?

Sandeep Singh
Managing Director, Alkem Laboratories

No. Great. Saion You're right. See, the issue is, first off they are expensive, and we are not of the mindset that we'll overpay. Second, a lot of times companies are available for acquisition, not just brands. That leads to some other complications of workforce and different culture and things like that. Very rarely is an opportunity where you can acquire only brands. Whenever that happens, most of the time we see that it's expensive. I do see your point, but I'm not very sure whether, you know, it will work out in our favor in terms of where.

We, you know, we already have 9,000 people. That's 10,000 medical reps. If you go and acquire businesses on the whole, it comes with own sets of medical reps and different cultures and all. It'll become a challenge, Saion. We'll be cautious, and I'm not sure whether we'll do large deals over there.

Saion Mukherjee
Analyst, Nomura

Okay. Thank you, sir.

Operator

Thank you. The next question comes from the line of Nimish Mehta, Research Delta Advisors. Please go ahead.

Nimish Mehta
Analyst, Research Delta Advisors

Yeah, thanks for the opportunity. My question is regarding the gross margin. I'm very confused. When I look at the full year gross margin that we discussed so far, more or less they are, you know, in line with what we had last year. Last year also we mentioned about, you know, that the input cost prices are going up and stuff like that. How exactly, I mean, how exactly is the impact coming, you know, on the gross margin? I'm still not able to understand. Although gross margin remains the same.

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. Nimish, you are very right. In fact, in this year, we have a positive of 20 basis points in gross margin, so it's a plus. Let me just give you component and this price inflation, mainly in U.S., it has impacted, and on overall basis, on annual basis, we don't have any significant contribution on account of increase in material cost. Then I'm talking raw material cost or pack material. Yes, in quarter four if you go, you can see because whatever procurement we have, we did in the month of November and December, we consumed partially in quarter four, and we are going to consume going forward in quarter one or quarter two going forward.

It is going to have impact in 2022-23. As far as 2022 is concerned, you are very right. Input cost increase is not having any significant impact. By way of better product mix and better gross margin in our gross margin, in fact, there is addition of 20 basis points in that.

Nimish Mehta
Analyst, Research Delta Advisors

Right. Even if we compare the fourth quarter, and I'm comparing year-over-year, I think that should be the right way. You can correct me if that is not. You know, I don't see inside there is an increase in the gross margin. What I'm trying to see is that in every Q4 you have a lower gross margin. What is changing even in this quarter? Or we need to compare it quarter-over-quarter?

Sandeep Singh
Managing Director, Alkem Laboratories

Nimish, if you remember Q4 of last year, there was an inventory write-off, which has pulled down the gross margins. If you adjust for that, there is a, you know, YoY dip in the gross margin.

Nimish Mehta
Analyst, Research Delta Advisors

Right.

Sandeep Singh
Managing Director, Alkem Laboratories

Even if you adjust that, and compare it on full year basis also there is small dip. Okay. What has helped us this year is the product mix has improved. Last year, FY 2021, India, around composition of sales was 65%. It has gone up to 70%. You know, helped by mix and last year there was this inventory write-off. If you adjust both, then there is a marginal dip in, you know, gross margin because of the inventory, because of the raw material cost. When we are saying 100-150 basis points of impact, that is on year-over-year level, FY 2023 compared to FY 2022. If it ends the year at 60.7%, we are saying about a 100-150 basis points impact on that number on full year basis.

There's a seasonality across the quarter, and the seasonality is gonna remain. After normalizing the seasonality on YoY basis, it's going to be 150 basis points.

Nimish Mehta
Analyst, Research Delta Advisors

This 150 basis point that we are talking about does not take into consideration the fact that we might have better product mix and, you know, better. We're also likely to see good amount of price increase in the domestic market and all of those things, right? So that is.

Sandeep Singh
Managing Director, Alkem Laboratories

We are factoring all those things. What Dubey sir was sharing was, you know, our normal gross margin is around 61%-62%.

Nimish Mehta
Analyst, Research Delta Advisors

Okay.

Sandeep Singh
Managing Director, Alkem Laboratories

This has come down to close to 60%. You know, so 60%, 59%-60% is where we may end in FY 2023 because of the high raw material cost. Let's say FY 2024 onwards, this should go back to 60%-61% levels again.

Nimish Mehta
Analyst, Research Delta Advisors

Okay, got it. Lastly, you know, once again on the same thing, this will also include some. I mean, last year I think you mentioned that we might be launching few low competition products in U.S. Are we likely to do that and this margin guidance is net of that as well?

Sandeep Singh
Managing Director, Alkem Laboratories

We always hope to launch, you know, launch products with less competition. Ultimately, competition dictates whatever, comes through.

Nimish Mehta
Analyst, Research Delta Advisors

Okay. This margin is net of all those factors, right?

Sandeep Singh
Managing Director, Alkem Laboratories

It's the same business as usual.

Nimish Mehta
Analyst, Research Delta Advisors

Okay. Thank you very much.

Operator

Thank you. The next question comes from the line of Nikhil Mathur with HDFC MF. Please go ahead, sir.

Nikhil Mathur
Analyst, HDFC MF

Hi, good evening. I just wanted one clarification. Did I hear it right that your U.S. growth guidance for FY 2023 is 10%-12%?

Sandeep Singh
Managing Director, Alkem Laboratories

Yes, that's right. Revenue.

Nikhil Mathur
Analyst, HDFC MF

Okay. Alkem has done $320 million in FY 2022 despite taking into account high single-digit growth in business also we have guided to. That equation works out to be somewhere around 66% or $66 million to arrive at a 10% growth. I'm just trying to understand. I mean, there's a bit of cynicism in me which kind of feels that this seems a bit stretched in this particular guidance. Can you share some key pieces of why this big guidance is easily achieved?

Rajesh Dubey
CFO, Alkem Laboratories

Sorry, what is the last part? I missed that.

Nikhil Mathur
Analyst, HDFC MF

I'm saying that this guidance seems a bit aggressive. I mean, 10%-12% growth on a erosion of 8%-10%. Are there any specific pieces of why you are confident on the U.S. outlook for FY 2023?

Rajesh Dubey
CFO, Alkem Laboratories

The entire FY 2022 was depressed compared to FY 2021. You know, as you can see, we've grown by 5% in the current year. Now if I'm basically guiding 10%-12% increase over FY 2022, in effect, we are only, you know, guiding for a 7% increase over FY 2021. Yeah. We are confident because number one, as I said, the price deflation is reduced compared to what we have seen in FY 2022 as we sit right now. Then number two, of course, we will always hope to do better with our new launches. As I mentioned earlier, in FY 2022 we actually did very well compared with our new launches compared to our own performance in the previous fiscal before FY 2022.

We were not able to demonstrate it because of our higher price erosion during the last year.

Nikhil Mathur
Analyst, HDFC MF

Okay. To achieve this full year number, let's say $80 million-$90 million in terms of QTR, would that be visible in the first quarter itself or do you think that it's gonna be second half is gonna be much bigger than what we'll deliver in terms of immediately?

Rajesh Dubey
CFO, Alkem Laboratories

Yeah. No, look, you know, we obviously expect our performance to grow quarter-on-quarter. First quarter, if we are comparing year-on-year compared to quarter one, yes, I would expect a 10%-12% increase. We need to obviously see that coming through before we update our guidance or we update our numbers.

Nikhil Mathur
Analyst, HDFC MF

Okay. Sure. And one slightly larger picture question on India. I mean, it's more than two years now since the pandemic. So any thoughts you can share on your expectations on the acute and chronic growth vis-a-vis what it was prior to COVID, and development in trade generics and sales force efficiency. Can you share some of your forecast on these four segments of key labels for the domestic market versus pre-COVID, what your expectations would be now?

Amit Ghare
President of International Business, Alkem Laboratories

Yeah. We think that this year the things should almost be normal, you know, to pre-COVID levels. Our growth in acute will sustain. That's what, you know, we just said earlier, that this year the growth of acute will be in a range of around 10%-11%. Chronic, you know, those markets will grow at around 10%-11%, and we'll aim for double the growth of, you know, market in chronic. Around roughly we can say 10%-11% growth in acute and around 20-odd% growth in chronic. You know, averaging of around 13% for the domestic business. Trade generics, additionally we have seen, good growth, so we hope they will continue similar trends in the coming year as well.

Nikhil Mathur
Analyst, HDFC MF

I think this helps. Let me just rephrase my question. Has there been any structural change in how you perceive growth for different segments and also how you approach customers? Things might be a bit more clear now since the last meeting had commercial effect. I'm looking for a bit of structural perspective on how these labels actually are free to buy here today.

Amit Ghare
President of International Business, Alkem Laboratories

See, you just heard me saying that we have already upfront a lot of people, around 1,000 people in every year, last two years. We don't expect major structural change in our business approach. One is structural change in the organization, so our focus areas will remain same. I'm not going to dilute from them. As far as meeting doctors is concerned, almost now the meeting customers is pre-COVID levels, so there's no major change in that. I assume that you are asking about utilization of those digitals and all. Yes, there will be slight, you know, a change towards to reach masses through digital media and that can be, you know, a little factor.

Normally this will go to pre-COVID levels with some addition of digital approach in our business.

Nikhil Mathur
Analyst, HDFC MF

Got it. That helps. Thank you.

Operator

Thank you. The next question comes from the line of Saion Mukherjee with Nomura. Please go ahead.

Saion Mukherjee
Analyst, Nomura

Thanks for the follow-up again. Just one clarification, Amit, in response to Nikhil's question, which you mentioned, a growth of 10% in quarter one. This would put our U.S. revenues at around $90 million, which is almost $20 million higher than what we are in fourth quarter.

Amit Ghare
President of International Business, Alkem Laboratories

No. That was compared to FY 2022. It was not compared to FY 2021. FY 2021 was a completely different quarter 1, that's not in relation with that year.

Saion Mukherjee
Analyst, Nomura

No, I mean, in the first quarter, you know, this quarter, FY 2023, you know, as you mentioned, you will deliver a 10% growth on Q1 FY 2022, which was higher, right? It was around $80-odd million. So you should be closer to $90 million in this quarter if you have to grow 10% on Q1 of FY 2022.

Amit Ghare
President of International Business, Alkem Laboratories

Right.

Saion Mukherjee
Analyst, Nomura

That would mean a QoQ growth of almost INR 17 million, which is a big number, 73 million. I mean, at the middle of this quarter, are you having that visibility of sort of, you know, getting close to INR 90 million in Q1 FY 2023?

Amit Ghare
President of International Business, Alkem Laboratories

Yeah. Saion, rather than getting into absolute numbers, I think Nikhil's question was essentially trying to ask me is there something during the year that we are depending upon for delivering this growth? That's how I perceived and understood it. What I answered there was that we are not dependent on one event or one product or something which will deliver this growth for us. We need to deliver our growth, whatever that we've talked about, fairly evenly during the year. Therefore, what I answered was that even in quarter one we are expecting to deliver some growth over last year's numbers, FY 2022 numbers. That's what please read it in relation with that.

Specifics for each quarter is there are ups and downs. Some of it will get corrected. For example, first quarter in FY 2021, if you remember, was a very high quarter. Obviously that is not a correct number or a correct base to look at.

Saion Mukherjee
Analyst, Nomura

Okay. Okay. Thank you.

Operator

Thank you. As there are no further questions, I would like to hand the conference over to Mr. Gagan for closing comments.

Gagan Borana
Head of IR, Alkem Laboratories

Thank you everyone for attending this call. If any of your queries have remained unanswered, please feel free to get in touch with me. Thank you once again.

Rajesh Dubey
CFO, Alkem Laboratories

Thank you.

Operator

Thank you. On behalf of Motilal Oswal Financial Services, that concludes the conference. Thank you for joining us, and you may now disconnect your lines.

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