Alkem Laboratories Ltd
NSE:ALKEM

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Earnings Call Analysis

Q1-2025 Analysis
Alkem Laboratories Ltd

Alkem Laboratories Q1 FY25 Earnings Growth

Alkem Laboratories saw a strong start to FY25 with a notable increase in EBITDA margins, rising from 13.1% to 20.1%. The domestic market remains crucial, while growth in emerging markets is also prioritized. A key development was the resolution of U.S. FDA issues at the Baddi facility. The company's net profit reached INR 545 crores, and it plans to maintain an annual EBITDA margin of around 18%. Alkem outperformed the market in six therapeutic areas, including neuro, CNS, and dermatology.

Improved Profitability and Strong Domestic Business

In the first quarter of FY '25, Alkem Laboratories saw a significant improvement in profitability. The company’s EBITDA margin increased by 700 basis points, rising from 13.1% last year to 20.1% this quarter. This improvement was driven by a better product mix, favorable API (Active Pharmaceutical Ingredients) pricing, and strong cost control measures. The domestic segment remains Alkem's stronghold, and efforts are being made to grow large brands and address portfolio gaps. Furthermore, Alkem is focusing on expanding its footprint in emerging markets.

US FDA Compliance and Regulatory Commitment

A notable achievement for Alkem this quarter was the successful resolution of US FDA's Form 483 observations at the Baddi facility. This marks a significant milestone, underscoring the company's commitment to quality and regulatory compliance. This resolution is expected to support Alkem’s operations and foster confidence in its production standards.

Market Performance and Growth in Key Therapies

Alkem registered an 8.4% year-on-year growth, in line with the Indian Pharmaceutical Market's (IPM) growth of 8.7%. The company outperformed the market in six key therapy areas: anti-diabetic, neuro/CNS, gastrointestinal (GI), dermatology, vitamins, minerals, and nutrients (VMN) therapy. Alkem’s rankings improved in neuro and respiratory therapies. This performance is indicative of the company's strong market presence and strategic focus on high-growth segments.

Guidance on Margin and Revenue Growth

Alkem Laboratories maintains a positive outlook for FY '25. The company aims to sustain its EBITDA margins around 18%, projecting an annual improvement of about 100 basis points. While the current quarter saw margins around 20%, ongoing investments in new business opportunities, including new facilities and R&D, are expected to moderate the full-year margin slightly. Alkem expects gross margins to improve by 100-150 basis points for the year due to stable API pricing and a continued focus on high-margin products.

Future Growth Opportunities and Investments

Alkem is investing significantly in future growth opportunities, particularly in the Contract Development and Manufacturing Organization (CDMO) business, with investments ranging from INR 400 to 450 crore. The company is also venturing into biosimilars and medical devices, sectors expected to contribute positively from FY '26 onwards. These investments highlight Alkem’s strategic focus on diversifying its revenue streams and enhancing long-term growth.

Challenges and Strategic Responses

The company addressed concerns about slower growth in some domestic segments like anti-infectives and pain management. While these areas showed sluggishness, management expects improved performance from Q2 onwards. Alkem remains bullish about its domestic business, forecasting growth in line with market expectations of 8-10% annually. Additionally, Alkem faces ongoing patent litigation issues in the U.S., impacting the launch timeline for certain products. The company remains cautious but hopeful about favorable litigation outcomes in the future.

Earnings Call Transcript

Earnings Call Transcript
2025-Q1

from 0
Operator

Ladies and gentlemen, good day, and welcome to Alkem Lab Q1 FY '25 Earnings Call hosted by Motilal Oswal Financial Services Limited. [Operator Instructions] Please note that this conference is being recorded.

I now hand the conference over to Mr. Tushar Manudhane from Motilal Oswal. Thank you, and over to you, sir.

T
Tushar Manudhane
analyst

Thanks, Siddhant. Good evening, and a warm welcome for 1Q FY '25 earnings call of Alkem Laboratories. So on the management side, we have Dr. Vikas Gupta, CEO; Mr. Nitin Agrawal, CFO; and Ms. Purvi Shah, Head of Investor Relations.

Over to you, Vikas, sir, for the opening remarks.

P
Purvi Shah
executive

Thank you, Tushar. So good evening, everyone. Earlier in the day, we have released our financial results, press release and investor presentation, which are also posted on our website. We hope you all had the opportunity to review it.

Before we proceed with this call, we'd like to remind everyone that this is being recorded and the call transcripts will be available on our website. We'd also like to add that today's discussion may include certain forward-looking statements, which must be viewed in conjunction with the risks that our business faces. And after the end of the call if any of your queries remain unanswered, please feel free to contact us.

I now request Dr. Vikas Gupta to discuss the quarter's highlight and future strategy. Thank you, and over to you, sir.

V
Vikas Gupta
executive

Thank you, Purvi. Good evening, everyone. We really appreciate your presence for today's first quarter FY '25 earnings call. I'll start by presenting an overview of the operational and financial achievements for the first quarter. And after this, we will be happy to answer your questions and engage in a discussion.

We are happy that our efforts to improve the profitability have started paying off, and we have seen a marked increase in margins during the quarter. We are committed to maximizing our EBITDA margin by carefully managing our product mix, controlling costs and taking advantage of the favorable raw material pricing environment.

The domestic business is our stronghold, and we expect to build on it by furthering the growth of our large brands and bridging the portfolio gaps. Simultaneously, we are also focusing on growing our business in emerging markets.

During the quarter, one of the important developments was the successful resolution of U.S. FDA's Form 483 at our Baddi facility. At Alkem, we remain steadfast to prioritizing quality and regulatory compliance.

Just to give you a few highlights of first quarter. This has set a good beginning for the whole financial year in terms of profitability improvement of the company. We are pleased to announce the successful resolution of all the observations that we had received from Baddi facility. This exemplifies our unwavering commitment to adherence and regulatory compliance.

Our EBITDA margin improved by 700 basis points as compared to last [ year ] Q1. So from 13.1%, we have improved it to 20.1% for the quarter. Net profit after minority interest for the quarter stood at INR 545 crores. According to IQVIA, we have outperformed -- we have registered a growth of 8.4% Y-o-Y compared to the IPM growth, which grew at 8.7%. So we are more or less in line with the market growth.

We outperformed the IPM in 6 therapies, which is anti-diabetic, neuro and CNS market, the GI market, dermatology and VMN therapy, and our ranking has improved in neuro and respiratory therapies. We aim to sustain and carry forward the momentum in the coming quarters for this financial year.

Thank you for your patient listening, and the house is open for any questions.

Operator

[Operator Instructions] The first question is from the line of Kunal Dhamesha from Macquarie.

K
Kunal Dhamesha
analyst

Congratulations on a good set of numbers. One question on this product called mirabegron, I believe we have a tentative approval for this product. So should we bake in as a near-term opportunity for us?

V
Vikas Gupta
executive

So Kunal. Thanks -- thanks for your compliments. And on mirabegron, as I had spoken on the last call as well, 1 or 2 companies have launched it and they are under litigation, whereas we have -- we are bound by the settlement agreement that we have with [indiscernible]. So unless the final outcome of all the litigations on the patent are clear, we would not be -- because we are bound by the settlement agreement. I don't see it getting launched in -- before the agreement date and which would be somewhere, I would say, [ '26 or '27 ], somewhere around that time.

K
Kunal Dhamesha
analyst

Okay. Sure, sir. That is helpful. And in terms of our EBITDA margin, with tracking around 20% in this quarter, and we had given a full year guidance or the medium-term guidance that every year, we'll improve it by 100, 250 basis points. So where do we stand and is there a meaningful change in a way, we look at profitability now for our business. And what has led to this meaningful improvement, what has driven this meaningful improvement for us in this quarter?

V
Vikas Gupta
executive

Yes. So I will begin by picking up the last part of your question. The reasons for this improved profitability. One is a good product mix. Second is improvement in the API pricing. So these are -- and of course strong cost control initiatives that have been running for various quarters within the organization. So I would say these are the reasons for this significant improvement that we have seen.

As far as the overall profitability numbers, I've always maintained that we'll continuously be improving it on an annualized basis. Of course, for the yearly guidance that we have given in the past, that remains the same, which should be somewhere around a similar number, overall number that we had in the previous year as well, around 18% is what we have blocked because as I mentioned that though operationally, we would be improving it by a 100 basis points year-on-year. But we are making investments into our new business opportunities.

And that would say, require some investments in the future growth opportunities. Because of that, our guidance has been close to 15%, and we maintain the same for the year -- for the rest of -- I mean for the balance part of the year as well. So on an annualized basis, we will be pretty much in line with the guidance that [indiscernible].

K
Kunal Dhamesha
analyst

Sure. Sir, and one last one from my side. In terms of the ForEx gain or losses, can you highlight that number for this quarter? And where is it baked into our numbers?

V
Vikas Gupta
executive

So -- of course, we've not had -- we never give very granular breakup. But this is mostly from Chile this year in this quarter that we have had it to the tune of INR 15 crores as a ForEx gain. So...

N
Nitin Agrawal
executive

That is we put it as part of other income.

V
Vikas Gupta
executive

Yes.

N
Nitin Agrawal
executive

So that is not part of EBITDA.

V
Vikas Gupta
executive

So that features in the other operating income rather than -- sorry, other income, other income and not in EBITDA.

K
Kunal Dhamesha
analyst

All the best.

Operator

The next question is from the line of Bino from Elara Capital.

B
Bino Pathiparampil
analyst

Just following up on the previous question on margin. For the full year, I just heard your answer to the earlier question, does it mean for full year EBITDA margin you are expecting similar to last year's 18% or 100 basis point improvement on top of that, which makes it 19%?

V
Vikas Gupta
executive

So what I said is that, additionally, we would be improving it. But because we have new investments to make in the newer growth opportunities in large part -- and some part of it will also be on the OpEx side, so which will dilute our EBITDA by, say, another 1%. So net-net, what we would arrive at should be somewhere around 18%. But of course, if the API environment gets even more favorable, then we may look at some upside. But as is basis, currently, we are maintaining our guidance around 18%.

B
Bino Pathiparampil
analyst

Understood. Second, you mentioned that there was a favorable API pricing environment. Do you mind calling out a couple of APIs, where there has been significant price reduction which has helped you?

V
Vikas Gupta
executive

Yes. We had, say, for example, dapagliflozin, we had sitagliptin. These are now substantial value products for us, and we saw a significant reduction in some of these molecules on the API pricing. And we expect them to stay there so for the balance part of the year. Even on the paracetamol side, we saw some softening, of course, not as significant as we saw on the other 2. But I think these are some of the products that I would like to call out.

B
Bino Pathiparampil
analyst

Understood. And finally, [indiscernible] in [indiscernible] prices [indiscernible].

V
Vikas Gupta
executive

Even we are eagerly working like [indiscernible], I would say. We are yet to see any impact of PenG, so to say. In fact, in the recent times, I'm seeing that PenG prices are even seeing a marginal increase. So unless we see the large Indian players coming up in market with the offerings. I don't think we are seeing softening in the China suppliers on the PenG.

Operator

[Operator Instructions] The next question is from the line of Neha Manpuria from Bank of America.

N
Neha Manpuria
analyst

My first question is on the gross margin. Since you mentioned the API price environment and product mix. While the product mix can change quarter-on-quarter. I just wanted to get a sense on how much of this gross margin improvement that we have seen is sticky, meaning that -- assuming that API pricing remains where it is, you don't see any further improvement in that. How much of this could sustain even if the product mix becomes inferior over the rest of the quarter?

V
Vikas Gupta
executive

So I see the API pricing remaining more or less stable now. So I'm not foreseeing any significant change on the API environment. But as far as the product mix is concerned, of course, in the Q2 and Q3, we see our anti-infective portfolio, [indiscernible] which sort of changes the product mix.

So in terms of the product mix change, might impact margins for 2 quarters by, say, 2 percentage, that's the kind of estimate that we have and that we may see. But on the API pricing, I see it quite stable. In fact, if the PenG thing works to our favor in the coming quarters, we may see an improvement over there. But otherwise, as is basis, this is what our sense is.

N
Neha Manpuria
analyst

Okay. So just to clarify, sir, so last year, we saw about 61% margin in the entire year. So given the benefit of API pricing, that what we have reported in the quarter, that should -- is already benefiting us by 100, 150 basis points. Is that a right assessment?

N
Nitin Agrawal
executive

So Neha, you're right that last year, our gross margin was 61% this year. considering the resin product mix and better margin in the U.S. market and also the further investment in API, we see it improve -- further improvement of around, say, 150 basis points in our gross margin for the full year. Definitely, quarter 1 was better because of, again, the product mix, the domestic competition was higher as compared to international.

N
Neha Manpuria
analyst

Okay. That's helpful, sir. And my second question on the investments in the future growth opportunities that you've talked about, the 100 basis points. If you could highlight what these opportunities are? Is this the CDMO business that we talked about. So where essentially are we investing this. How long do you think this investment continues? And when do we start seeing revenue from these opportunities?

N
Nitin Agrawal
executive

So as we discussed in our last call also, we are investing in our [indiscernible] U.S. facility. And this -- it will be mainly for the CDMO business. The total investment is around between INR 400 crores to INR 450 crores. And as we also highlighted in last analyst call that since it will take some time for this business to actually breakeven. But this year, there may be some amount of losses, which business will incur and maybe in say first few quarters of next year also. But really very hopeful that we want to build this business. And maybe from FY '26, itself, we will see the positive business from this. But this year, there will be some impact [indiscernible].

N
Neha Manpuria
analyst

Understood. Okay. And FY '26 is when you will break even on it?

V
Vikas Gupta
executive

Yes.

N
Neha Manpuria
analyst

Understood. And my last question is on the India business. I know I've asked this before also. Some of the larger therapies, pain and anti-infector we seem to be growing slower than the market. These are fairly large therapies for Alkem. I know we're doing very well in the other parts -- other therapies. But anything that you can highlight on what we are trying to do to address the lower growth in this segment versus the underlying market?

V
Vikas Gupta
executive

So Neha for the past few quarters, we had seen some market also sluggishness as far as these therapies were concerned. I'm hopeful, and I'm seeing a trend as well in the previous quarter also, it was better than the previous quarters before. And now I am expecting that from Q2 to Q3, we should start getting decent growth on our large portfolio. And that is why we are bullish about our overall domestic performance.

So it's a -- I think it's a good progress that we are making month-on-month, quarter-on-quarter. And we should see even these large therapies begin to contribute to our overall growth.

N
Neha Manpuria
analyst

Implying that these will grow in line with the underlying market? Would that be fair to assume?

V
Vikas Gupta
executive

Because these are our leadership positions in many of these segments. So at least we will be in line with the market growth, as far as these therapy levels.

N
Neha Manpuria
analyst

Yes. Sorry, sir, if I miss -- missed this, but what's the growth guidance that we've given for the India business? Have we mentioned that? I joined the call a little late.

V
Vikas Gupta
executive

So we've always maintained in line with the market is what will be our growth, and which should mean that I'm expecting the market to grow somewhere between 8% to 10% and should be similar for us as well.

Operator

The next question is from the line of [ Viraj Shah ] from Motilal Oswal.

U
Unknown Analyst

So my first question is on price volume, if you could let me know regarding the price volume and new launches growth in domestic formulation segment?

V
Vikas Gupta
executive

So in domestic, we have had a volume growth of close to some 1.5%. We have -- the new launches have contributed to around 2.5%. And balances are, I would say, price growth, which is again close to 2.5%.

U
Unknown Analyst

Okay. Can you also let me know regarding the price erosion in base business for U.S. generics?

V
Vikas Gupta
executive

So like I always maintained, the U.S. generic is seeing a single-digit price erosion at trend continues even for this quarter. So we are seeing that kind of price erosion in our U.S. businesses.

U
Unknown Analyst

Okay. And regarding PenG, so apart from PenG, how do you see the lower RM cost benefiting Alkem?

V
Vikas Gupta
executive

So there are certain other APIs also, which I see that even going forward, we could see some softening, but I mean this is something which is difficult to predict. So some of the API prices, the molecules that I called out on the previous question, we have seen definite reduction and that should start -- that has started showing the impact in our numbers as well.

So I would say that, that is more sustainable. But I'm quite hopeful that in the coming quarters, we should see a few more products, where the API pricing environment should get more favorable. But I'll be able to give specifics only when they start giving us the real benefit.

U
Unknown Analyst

Okay. Okay. And regarding the employee cost, there was a 1 billion increase in employee cost sequentially. So if you could let me know the sustainable rate, which we can consider for that?

V
Vikas Gupta
executive

So I think that is largely the inflection related agreements that we have generally for our employees. So -- and it is pretty much in line with what we had anticipated or budgeted for the year. So it is -- there is nothing abnormal that has come in as far as manpower increase.

U
Unknown Analyst

Okay. And if I could put in one more last question. The R&D expense, it was lower for the quarter. So how do you think for FY '25 on absolute basis that would be as percentage of sales?

V
Vikas Gupta
executive

The first quarter is always within the range of 4.1% because most of our filings are loaded towards Q3 and Q4. So the annual spend will be within the range of 4.5% to 5% and in terms of absolute. So we will continue to keep it under that percentage. So that is what we have been always maintaining.

Operator

The next question is from the line of Bharat Celly from Equirus.

B
Bharat Celly
analyst

I just wanted to understand on the margin guidance again. So in the last quarter, when you mentioned that there is a [indiscernible] margin at that time, we were estimating that our gross margins will remain more or less slightly flat around [indiscernible]. Now configuring, we are increasing our guidance -- gross margin guidance, to 2.5%, but our EBITDA margin guidance more or less remain same. Sir, is there anything which I am missing out?

V
Vikas Gupta
executive

So if you look at our, say, last year results, the quarter 1 gross margin was lower compared to the other 3 quarters. Actually, the API prices impact, we started seeing from quarter 3 and quarter 4. And also, it's a unique product mix. So if you look at quarter 4 margin of last year, quarter 3 margin of last year, it was better than quarter 1. And this -- say, improvement in gross margin it will continue -- or has continued in quarter 1, and that is why we see -- we have shared that our overall guidance for the year will be [indiscernible] so last year was [indiscernible] lower margin -- gross margin of quarter 1.

B
Bharat Celly
analyst

Right. So in the first quarter that we had guided for 18% EBITDA margin at that time, we are estimating our gross margins to be around 61. Now since our gross margin guidance has increased by 150 bps, yet our EBITDA margin guidance more or less remain same. So I'm just asking why that benefit is not showing to EBITDA, is there any incremental cost which your facing...

N
Nitin Agrawal
executive

Sorry to interrupt in our last call also, we have shared that our gross margin for the full year increased in the range of 62% to 64%.

B
Bharat Celly
analyst

Okay. And on [indiscernible] actually, I thought that considering the 3 players have already launched that drug that would have [indiscernible] settlement. Isn't that [indiscernible]? So what I'm asking is [indiscernible] yes you have launched [indiscernible] is that, that going to trigger our settlement?

V
Vikas Gupta
executive

No. No. No. So like I told you, they are also under litigation and our -- we are bound by our settlement agreement, which clearly mentions that we can launch it only when -- after the final outcome of all the patent clause, patent infringement that has -- so we will be launching it only after that. So there's an at-risk launch, I think would be players are under litigation with the innovator. So we will be waiting for the final outcome of the litigation.

B
Bharat Celly
analyst

And Vikas sir, in case let's see -- let's say if those generics built the case, will it trigger our launch?

V
Vikas Gupta
executive

See, I will just wait for all the litigations related to any patent for mirabegron to get over. And it's only after that, we will be getting into the market. There are various litigations, I think, that are going on for different patents with regards to mirabegron. So once all the -- we are bound by the settlement agreement and that once all these litigations are over [indiscernible] enter the market. So that's when we will act.

B
Bharat Celly
analyst

Okay. That's helpful. And again, on the domestic business. Are we...

Operator

Sorry to interrupt Mr. Bharat, we request you to get back to the question queue for any follow-up questions.

The next question is a follow-up question from the line of Kunal Dhamesha from Macquarie.

K
Kunal Dhamesha
analyst

In terms of U.S. outlook for FY '25 in terms of product launched and your growth expectation, if you could provide some color here?

V
Vikas Gupta
executive

So in terms of our U.S. growth, I've always maintained, we are looking at a single-digit growth from U.S. market. In terms of the new launches, we launched in generic supply in Q1. In Q2, we have just introduced dabigatran. And among the significant ones, I think that should be the one which we are very hopeful, which should start showing impact on revenue in Q3 and Q4. So that's about the new launches.

With regard to refiling, I look forward to around 8 to 10 filings that we would do in the current financial year. But a large part of it will come in Q3 and Q4. So that's how I think our overall filings for the year.

K
Kunal Dhamesha
analyst

And that -- because of that, are we expecting our R&D expense to basically reach up to 4.5% to 5% versus 4.1% in this quarter?

V
Vikas Gupta
executive

Yes, because it's the phasing of the spend is like that because year-end, we will end at between 4.5%.

K
Kunal Dhamesha
analyst

Sure. And sir, one on the RoW business or the other international market business, which has just seen a top line growth of 2% year-on-year. So is any particular geography wherein we have seen some issues? Or how should we look at from an FY '25 perspective of this business?

V
Vikas Gupta
executive

No. So 2.2% is not from the RoW. In fact, the RoW market, the emerging markets and the -- some of the European markets, we are seeing very good growths -- above even 60% kind of growth. But their base is right now not so high. But we want to develop those markets for future because these are the markets where we get much better profitability as compared to the U.S. market.

So ROCE is very good from those markets as compared to the U.S. market. And that's what we are working on, on building top line from the non-U.S. market. So especially the emerging markets and the -- some of the European markets. So I think that's what we are now focusing on in terms of our international business, and we will continue that focus [indiscernible] very strong.

U
Unknown Executive

Just to add. I think you're talking about the non-U.S. business, there was a growth of [indiscernible]. So under our non-U.S. [indiscernible] major contributor and this year, we seen pricing issues in Australia, and that is why the quarter for us [indiscernible] lower [indiscernible] impacted the overall growth of non-U.S. market. But all the supply issues into are being set, we are very [indiscernible] that and our growth will jump back in the balance quarters.

K
Kunal Dhamesha
analyst

Sir, this Australia issue, is it lost sales or deferred sales? How should we look at it?

V
Vikas Gupta
executive

No, it is just for this quarter, we were not able to supply a particular product because of our supply chain issues. And now we have resolved those issues, in the coming quarters, we will recover some -- I mean, large part of that sale.

K
Kunal Dhamesha
analyst

Sure, sir. And in terms of the [indiscernible] selling or the, let's say, our anti-infective portfolio. Are we a direct buyer from Chinese player? Or are we more like buying APIs from some of the Indian players who converts [indiscernible] API into a [indiscernible]?

U
Unknown Executive

Yes. Are you talking about supply PenG in Chile?

K
Kunal Dhamesha
analyst

Yes. Yes.

V
Vikas Gupta
executive

Yes. You're talking about Chile, or you're talking about domestic market?

K
Kunal Dhamesha
analyst

No, domestic market, sir. So anti-infective is a big therapy for us, right? And -- what...

V
Vikas Gupta
executive

Most of our procurement is indirect. So we don't get into component buying. But we keep view on various components of pricing and the various KSMs that are there. So that's why I said, so far, we haven't seen the impact or something on these prices from the suppliers.

K
Kunal Dhamesha
analyst

And as long as -- as soon as the sales in the KSM or intermediate prices happen, do you expect to get benefited from that. Is it correct to understanding?

V
Vikas Gupta
executive

Yes, that's how it flows because if our suppliers are getting some benefit, then that gets passed on to us. So I think that's how the market works.

K
Kunal Dhamesha
analyst

Sure, sir. And last one from my side with your permission. Our current medical representative count for the India business, including and excluding first-line managers?

V
Vikas Gupta
executive

So 12,700 is what our count is, and managers would be over and above.

K
Kunal Dhamesha
analyst

Roughly 10% is what we should assume?

V
Vikas Gupta
executive

I think we can get -- you can send a query, and we can share the right numbers with you. But I think generally it's in line with the industry.

Operator

The next question is from the line of Madhav from Fidelity.

M
Madhav Marda
analyst

Just had one question on the international business excess U.S. I think you explained why the growth was a bit soft in Q1, but the last few years, I mean this business has grown at 20%, 25% CAGR. If you look at the next 2 or 3 years, given that we're a bit of a higher base now versus what we had before. So any sense to how -- at what rate in this part of the business growth.

V
Vikas Gupta
executive

So I maintained the non-U.S. business, we would see mid-teens kind of growth even in the coming years, and that is what we are focusing on. And we will see that coming over a period of next 2 to 3 years.

M
Madhav Marda
analyst

And just the mix of entering new countries and expanding in the existing market, it's a mix of both how should we look in?

U
Unknown Executive

Yes, it's a mix of both. It's a mix of both.

M
Madhav Marda
analyst

Got it. Got it. And in terms of the margin packing order, this would be a similar margin business to India or higher or lower than India?

V
Vikas Gupta
executive

Some markets are similar to India, but some markets are lower, but at a blended level, you would see it may -- it is not as high as India, but in terms of -- it's not as low as U.S. So that's all I would say. I mean it is -- it's shade lesser than India, but it's not as low as U.S.

Operator

The next question is from the line of Saurabh Kapadia from Sundaram Mutual Fund.

S
Saurabh Kapadia
analyst

First on the -- what was the growth for trade generics in the quarter?

V
Vikas Gupta
executive

See, we don't share the segment-wise growth. But I've always maintained that it's a substantial scale business. It grows in line with whatever we see on the Rx side. So more or less, generally, we are seeing similar kind of growths on both the sides. But we -- we'll not have segment level growth data.

S
Saurabh Kapadia
analyst

Okay. And in terms of the additional cost you mentioned because of the new initiatives, can you quantify what could be the cost? And will it be starting from Q2, it will be more back ended?

N
Nitin Agrawal
executive

So mostly it is starting from Q3 onwards. And we have not quantitative -- we are not quantified in [indiscernible], but the impact on EBITDA will be around say, half 50 basis points in the current year for the -- for say, quarter 3 and quarter 4.

Operator

[Operator Instructions] The next question is from the line of Gagan Thareja from Ask Investment Managers. Your voice is breaking.

G
Gagan Thareja
analyst

Sir, I'm audible sir?

Operator

No, Gagan sir, your voice has breaking.

G
Gagan Thareja
analyst

Hello.

Operator

Yes. Gagan, sir.

G
Gagan Thareja
analyst

Yes. Sir, my first question is around the tax rate. I think for the full year, the guidance last given was 13% to 15%, 1Q has been 11%. Should we assume that going forward in the next 3 quarter's tax rate will be 15% plus?

V
Vikas Gupta
executive

So it will be in the range of 11% to 13% for the full year.

G
Gagan Thareja
analyst

Okay, 11% to 13%. So you're reducing the tax rate?

V
Vikas Gupta
executive

Yes.

G
Gagan Thareja
analyst

And secondly, I mean, are you making any provisions relating to the tax demand notice that you have received?

V
Vikas Gupta
executive

So see, we have not still received any demand to -- just to give the status of the [indiscernible] which happened. So Income Tax Department asked us to again file the return, and we have already refiled the return for last -- this year. Now we'll start the assessment. And once the assessment will get completed, then only we'll come to know about the result. So till date we are not received [indiscernible] survey which has happened in the month in last year.

G
Gagan Thareja
analyst

Okay, sir. Right. And sir, on the U.S. business, have you launched Suprep?

V
Vikas Gupta
executive

Yes, we have.

G
Gagan Thareja
analyst

When was this done, sir? Time [indiscernible].

V
Vikas Gupta
executive

In Q1. We just launched.

G
Gagan Thareja
analyst

Okay. So between Suprep and dabigatran, will you see those business managing to do a high single-digit sort of growth this year, despite being the 1Q not being strong?

V
Vikas Gupta
executive

See, on dabigatran because we've just introduced, we will start recognizing significant revenue only by Q3 and/or Q4, right? So from the financial year perspective, the contribution that will be there to the top line will not be so significant that it offsets the value erosion, price erosion that we have on the balanced portfolio. And that's why our guidance is going to be like that.

G
Gagan Thareja
analyst

Okay. And sir, final one on the domestic sales, can you give some idea of how the acute part in the chronic part of your India business has grown for the first quarter. And I noticed that on the cardio -- means, your still sort of going below IP and any explanations there in that?

V
Vikas Gupta
executive

So wasn't -- cardio has never been a very strong play for us. Our play has largely been on the anti-diabetic side, and that's where we have large brands. So that is where we have the -- an anti-diabetic in chronic, like I mentioned, in derma, CNS, in anti-diabetic, we are really outperforming the market. So there, our growth have been pretty strong. So I think that's on the overall growth.

In some of the other segments, where we have seen very high market [indiscernible] kind of performance is the PI portfolio, which is our largest portfolio and the VNM portfolio, which is our nutrition portfolio. So I think these are segments which are really timing the overall growth for domestic.

G
Gagan Thareja
analyst

But if I were to split your overall domestic sales, would it be fair to assume a 85-15 between from acute product...

N
Nitin Agrawal
executive

See chronic is increasing and somewhere close to 17% to 20% is what we have chronic. Yes.

G
Gagan Thareja
analyst

And it would be growing well ahead of the covered and is [indiscernible] covers markets.

V
Vikas Gupta
executive

Because I mentioned these segments where we are really going strong and growing faster than market. So I've called out.

G
Gagan Thareja
analyst

And on the non-NLEM portfolio, what kind of price increases would you have been able to see in this year?

V
Vikas Gupta
executive

So on non-NLEM portfolio, we are allowed to take a price increase of 10%, but we realize because of the inventory, et cetera, and some anti-market driven pricing pressures. Generally, we get 5% to 6% increase on the annualized basis.

Operator

Your next question is from the line of Bansi from JPMorgan.

B
Bansi Desai
analyst

Sorry, if you have answered this before. But just on the other expenses, excluding R&D, what has led to decline in the expense in the first quarter?

N
Nitin Agrawal
executive

So as Vikas said, in his opening statement that we have taken various initiatives in terms of cost savings. And if you look at, say, the service level penalty which incurred in the -- during the same quarter, that was significantly higher as compared to what we have incurred in this year.

And just to say, our production in Baddi and government has also significantly increase and [indiscernible] are to decrease and [indiscernible] penalty, and we also expect that increase further in coming quarters also, there will be a reduction -- further reduction service level penalty.

Other than that, last year, we incurred some ForEx losses. So if -- when we incur ForEx loss, we report it under other expense, while it will be -- ForEx will reported in the other income. So this year, there was a gain in the ForEx. So we have reported in the [indiscernible] last year it will be for the loss, it was put it in the other expense. And this has actually [indiscernible] led to improvement in the say as a percentage [indiscernible] reduction in other expense.

B
Bansi Desai
analyst

Okay. So the way I understood it that this appear more to be a sustainable number. Obviously, from the second half of the year, you will see increase related to our investments, cost increase on account of that. But barring that, this number looks more sustainable?

N
Nitin Agrawal
executive

So see going forward, I just also said that quarter 1 generally the R&D expense is lower when we're doing most of our filings in quarter 3 and quarter 4, and R&D expense in our quarter 2 result will be put it in the other expense.

So as a percentage of sales, it's very difficult I need to compute and say [indiscernible] separately that what will be the percentage going forward. But if you look at one-off items, so other than say R&D, we don't see that there are really other major items. But definitely, is very difficult to predict all the one-offs. But I think in absolute dollar term this will increase by INR 350 crores every quarter -- I mean as compared to Q1 and it will be within the [indiscernible].

Operator

The next question is from the line of Yash Tanna from ithought.

Y
Yash Tanna
analyst

Congratulations on a good set of numbers. I was going through the annual report, and I was reading the MD's message where he mentioned that Alkem is set to enter the medical device space and the OTC category, which will be a significant business driver going forward, and you guys are also exploring some inorganic opportunities in this space. So if you could highlight a little bit more on this? All my other questions have been answered.

V
Vikas Gupta
executive

Thank you, Yash. So I think I will once again reiterate that these are going to be key growth drivers. But as we mentioned earlier as well that we are taking steps to build this business. So when they will become meaningful, it's took a while. And we will keep you posted whenever we have specific details to share in this regard.

But yes, these are really a part of plans. And in the coming quarters, we are setting up to launch these businesses. And we're -- right now we're just working on getting these products to market. So we'll give you a specific update whenever we have to -- we have more specific details to share.

Y
Yash Tanna
analyst

Sure, sir. Got it. And just one more. Is it -- then -- can we assume that the cash [ pile ] that we have, the capital allocation can be more towards these categories versus more towards buying out brand or something?

V
Vikas Gupta
executive

I wouldn't say that. We have a part of -- as part of our plan, we are looking at heavy opportunity that comes up on table, I've said it in the past, we are open to -- and we are actually looking forward to any acquisition that we can do that can add value to the -- to our overall scheme of things -- and which are more strategic in nature.

So we have today a cash or a decent cash reserve. So I would say, which is I think -- and whenever any opportunity comes our way, we can figure out the routes to funding to get those -- to fund those opportunities. At this stage, so there's nothing more that I can share, but I can just tell you that there is a very strong intent to look at inorganic options as well.

Y
Yash Tanna
analyst

Sure, sir. Got it. And best of luck.

N
Nitin Agrawal
executive

Just to add on other expenses, like I think in the previous question I answered that maybe the increase of INR 50 crores for the R&D expense on top of quarter 1. But and we also discuss that there are other initiative -- growth initiatives which we have taken. So for growth initiatives also we see another INR 50 crores, INR 60 crores increased over quarter. So altogether, other expenses may increase [indiscernible] INR 100 crores, INR 210 crores from the base of quarter 1 for balance this to up lift.

Operator

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

T
Tushar Manudhane
analyst

Yes. Am I audible?

Operator

Yes, sir.

T
Tushar Manudhane
analyst

So just on the [indiscernible] trend, which has been largely stable, that as a part of cost rationalization exercise, are we going to see the reduction in number of the MR as well by the end of FY '25?

V
Vikas Gupta
executive

No. No. No. So MR is -- you will see increase in productivity. That is our focus rather than reducing people. I think there are assets, and we are seeing strong traction in our performance because of our feet on ground. So there is no such plan, but there will be a definite increase in productivity.

T
Tushar Manudhane
analyst

Understood. And...

V
Vikas Gupta
executive

Of course, there is [indiscernible] increase that we have as part of the plan in the numbers, but we will see an improvement in productivity.

T
Tushar Manudhane
analyst

Understood. And if you could share the OpEx related to Enzene Biosciences?

V
Vikas Gupta
executive

OpEx related to Enzene Biosciences?

T
Tushar Manudhane
analyst

Yes.

N
Nitin Agrawal
executive

So in quarter 1, there was an expense of around INR 90 crores as for fixed [indiscernible] including the depreciation.

T
Tushar Manudhane
analyst

INR 90 crores, including depreciation. And how do you see this panning for full year FY '25?

N
Nitin Agrawal
executive

Considering the -- it will increase a bit, as we discussed that we are also building our interest plan. So some amount of expenses in that target will be operational by end of say FY '25. So definitely, there will be the operating expenses. So there will be say against the third quarter in the balance quarters, there may be increase of 20%, 25%.

T
Tushar Manudhane
analyst

Sorry, INR 20 crore, INR 25 crore per quarter, right that or for the remaining year, you are saying?

N
Nitin Agrawal
executive

Yes. Yes.

T
Tushar Manudhane
analyst

Understood, sir. And...

N
Nitin Agrawal
executive

When I said that the other expenses will increase. So I think that is already covered -- this part is already covered.

T
Tushar Manudhane
analyst

So that is to do -- apart from Enzene Biosciences -- I mean, any other [indiscernible] would like to call out for increasing its OpEx, which will keep the EBITDA margin at the earlier guidance?

V
Vikas Gupta
executive

See, we have also entered into medical devices. We have signed an agreement with companies in the U.S. from where we will get the technology for a new infringement, and we are getting into these [indiscernible]. And we definitely it will take some time to breakeven. So this business will also actually impact the EBITDA margin in the current year.

T
Tushar Manudhane
analyst

Got it. Sir, just on this medical devices, we should be more as a hospital -- I mean B2B products or this should be more like on OTC products?

U
Unknown Executive

So these are maybe -- currently, the segment which we are signing, we will get technology [indiscernible] replacement. So we'll be dealing with through distributors, we will be promoting this products to hospitals and hospitals will actually impact this in the region.

Operator

[Operator Instructions] The next question is a follow-up question from the line of Kunal Dhamesha from Macquarie.

K
Kunal Dhamesha
analyst

One on the EBITDA margin guidance. I think I'm a little bit confused here. So the gross margins are expected to improve by around 100, 150 basis points year-on-year. And then at some point, we said there will be 100 basis point incremental end on the new initiatives. And then at some point, we said 50 basis point incremental spend in quarter 3 and quarter 4. So -- yes, I think I'm misunderstanding something. But how much is the new initiative spend that will kind of offset gross margin improve for us? And then the cost efficiency initiatives should so picking, right? So -- yes, how should we think about it?

V
Vikas Gupta
executive

So having said that the gross margin for the full year will be in the range of 62% to 62.5%. And also, I said that for quarter 1, the other expenses will increase by say INR 100 crore every quarter, mainly because of incremental R&D expense because quarter 1 generally on R&D expense is lower as compared to other quarters and also further investment in our biosimilar and Medical Devices business. So other expenses some -- on top of quarter 1, it'll increase by around INR 100 crores, INR 110 crores every quarter.

K
Kunal Dhamesha
analyst

And that is very good -- I think, right? R&D initiatives every thing 110...

N
Nitin Agrawal
executive

This is what we are expecting. The final number will come only after the actual results are published, but this is what we have estimated.

K
Kunal Dhamesha
analyst

Sure, sir. And one more question on the [indiscernible] seasonality. Since we still have a good amount of acute exposure, and we are roughly 1-month into quarter 2. So how do you say acute seasonality playing out for you this year?

V
Vikas Gupta
executive

The IQVIA number is yet to come out for the month of July. So we are also eagerly waiting. But again, just -- it will be too early, but it's much better than what it was last year.

Operator

The next question is the call from the line of Yash Tanna from ithought.

Y
Yash Tanna
analyst

Sir, you mentioned about improving productivity of the MR. So if you can tell us what is the consol productivity, and then break it up in acute and chronic. And also, what sort of productivity improvement are we targeting going forward?

V
Vikas Gupta
executive

So our consolidated productivity is at around INR 500,000, okay? And whatever -- we are not looking at any significant addition to the numbers that we have. And we have a top line growth aspiration of close to 8% to 10%. So you can see that would be largely the productivity growth.

Y
Yash Tanna
analyst

Sure. And sir, if you can break it up of chronic and acute?

V
Vikas Gupta
executive

Segment level, we've not -- but since acute is higher, you can consider, say, 10%, 20% higher productivity for acute and chronic is not way low now. So I would say it's catching up, but maybe 5% to 10% lesser than our consolidated level.

Operator

[Operator Instructions] As there are no further questions, I would now like to hand the conference over to the management for closing comments.

P
Purvi Shah
executive

Thank you. We'd like to thank everyone for participating in today's call and making this the meaningful discussion. If any of your queries still remain unanswered, please feel free to get in touch with us. Have a great weekend ahead. Thank you.

N
Nitin Agrawal
executive

Thank you.

V
Vikas Gupta
executive

Thank you, everyone.

Operator

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

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