Ladies and gentlemen, good day and welcome to the Alembic Pharmaceuticals Limited Q4 and annual FY 2022 financial results. From the management, we have with us Mr. Pranav Amin, Managing Director, Mr. Shaunak Amin, Managing Director, Mr. R.K. Baheti, Director Finance and CFO, Mr. Mitanshu Shah, Head Finance, Mr. Jesal Shah, Head Strategy, and Mr. Ajay Kumar Desai, Senior VP Finance. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone telephone. Please note, this conference is being recorded. I now hand the conference over to Mr. R.K. Baheti, Director of Finance and CFO. Thank you, and over to you, sir.
Thank you dear friends for joining this conference call where we are presenting our Q4 and annual results for FY 2022. I'm sure most of you have received our results, but let me briefly take you through the financial numbers. Operationally, Q4 was a good quarter for us. Both India business and U.S. generic verticals performed well, and Shaunak and Pranav will be talking about it in detail in their presentations. During the quarter, our total revenue is up by 11% to INR 1,416 crores. EBITDA was INR 164 crores. Profit before tax and profit after tax is down to INR 34 crores and INR 35 crores respectively. That's because of one-time non-recurring expense charged by Aleor. Aleor followed the previous year's practice. Alembic's consolidated profit before tax would have been higher by INR.
INR 188 crores than INR 222 crores, and net profit after tax would have been higher by INR 145 crores than INR 180 crores. EBITDA on a like basis could have been INR 286 crores, which is 20% of sales. EPS for the quarter is INR 1.80 per share for the quarter. It would have been 9.16 on like-wise basis versus INR 12.75 the corresponding quarter in the previous year. During the full year 2022, our total revenue was INR 5,306 crores. EBITDA was INR 955 crores, which is 18% of sales. Profit before tax and profit after tax was INR 650 crores and INR 546 crores respectively.
EBITDA, likewise, would have been INR 1,078 crores, which was 20% of sales. EPS for full year is 37.76 per share. It is 35.11 on like-wise basis versus it is 60.81 in the corresponding previous financial year 2021. The company declared a dividend of INR 10 per share, that is 100% corresponding to INR 14 per share or 700% in the previous year. As you are aware, the company acquired from Orbicular Pharmaceutical Technologies, a joint venture partner in Aleor Dermaceuticals, the balance 40% stake held by them in Aleor. Pursuant to said acquisition, Aleor becomes a fully owned subsidiary of the company.
Looking at the current market situations in US generic business, Aleor, the fully owned subsidiary of company, carried out a detailed review of its inventory census of R&D expenses, R&D development expenses, and decided to expense out an extra INR 188 crore in the current quarter/year. The breakup of that INR 188 crore is they charged off INR 65 crore in higher amortization expenses and the balance in various types of R&D expenses, that is employee benefits, material costs and other expenses. Borrowings. The gross borrowings at consolidated level is INR 630 crore versus INR 500 crore in March 2021, and the company has INR 61 crore in cash on hand versus INR 285 crore in March 2021, and their equity stands at 0.11. I will now hand over the discussion to Pranav for his presentation on international business.
Thank you, Mr. Baheti. The U.S. business, which has a good quarter, would say that 75 million. This is due to a couple of reasons such as the increased market share in some products as well as some one-time opportunities and some restocking of the distributed pipeline, which gives us confidence in the business moving forward. We also launched our first inhalation product in the U.S. market, Formoterol, in April. We continue to remain focused on the long term of the US business, backed by 15+ launches in the next year in FY 2023 and consolidating market share in existing products as well. As Mr. Baheti mentioned, Aleor is now a wholly owned subsidiary of APL.
We will get full control of strategy, operations and marketing of the entire dermatological portfolio, resulting in efficiencies and improvement in overall business outlook. The ex-US formulation business as well as the API business have both come off of a very high base of last year, thanks to Remdesivir. Although we are confident on both these verticals moving forward as well. R&D expense is INR 350 crore in the quarter, ex of Aleor's revised charge off. The Aleor, in order to compare with last year, the R&D was INR 152 crore, which is 11% of share of sales. We filed 11 ANDAs during the quarter. We also received 8 approvals in the quarter, including three tentative. We cumulatively have 160 ANDA approvals, including 22 tentative.
We launched one product in the U.S. during the quarter and 13 during the full year, and we plan to launch about 15 products in the next financial year. FDA inspection. We're working hard to address the observations issued by the FDA at our F-3 injectable facility located at Karakhadi. Remediation measures are underway, and we are in touch with the FDA to move towards full compliance. To the numbers, the U.S. generics grew at 17% to INR 557 crore for the quarter. The ex-U.S. generics de-grew by 19% to INR 188 crore for the quarter. Whereas the API business grew by 4% to INR 222 crore for the quarter. I will now hand over to Shaunak to take you through the India branded business.
Yeah. Good afternoon, everybody. The India business, I think for another quarter, our ability to show a continued buildup in momentum in the business continues. A large part of this growth was spread over not just a narrow part of the portfolio, which had some tailwind this quarter due to the COVID outbreak, but it was pretty much across the portfolio, key product therapies as well as our key focus on the portfolios. We expect this trend to continue going forward, and we hopefully with some more further strategic intervention, we expect to strategically accelerate this pace of growth. If I were to comment on the growth numbers, I think the India by...
India business grew by 25% to INR 449 crore and by 29% to INR 1,926 crore in 2022 on a year-over-year basis and a quarter-over-quarter basis. As per the industry, the market grew by 18% in Q4, and then this reflected a growth of 23% in IMS. Whereas the internal growth, the primary growth, sales growth is 29%. Across our key segments, both acute and specialty, we recorded a markedly better than market growth. In the specialty side, the market grew by 7%, whereas internally we grew by 13%, and majority of it's driven by our key product therapy categories of gastroenterology, gynecology and diabetes. At the acute level, we grew...
The industry recorded a growth of 25%, whereas Alembic recorded a growth of 60% by IMS and 57% growth internally. The anti-infectives, which had a strong tailwind this quarter, the industry showed a growth of 23%, whereas Alembic internal growth was 59% and the market reflection of 75%. Cough and cold, which is our second key segment in the acute business, industry showed a growth of 66%, whereas Alembic recorded an internal growth of 54%. Our animal healthcare continues to still grow at a very robust high double-digit pace with all our interventions, and that grew by 16% in Q4. For the financial year, the industry grew by 18%, whereas Alembic showed a growth of 29% internally. This is spread over both acute and the chronic side of it.
The PCPM for financial year 2022 is at INR 3.58 lakhs for the business. For the whole year, the animal healthcare grew by 26% over the high base of last year also. That was very positive upside for the performance. I would like to open the floor for further questions and answers, please.
Thank you very much, sir. Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to mute answers while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Thank you. The first question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Yeah, thanks for the opportunity. Good evening. Question on the U.S. Good recovery. You mentioned three points. How much of it is sustainable and how much of it is one time and stocking related?
You know, I've given a guidance. I said earlier that I think about 55 million or so should be our base business. I would say, yeah, 55 million or so should be our base business going forward. I still stick to that. I think apart from that, we had some stocking because we're moving our distributors, so there was some, maybe some stocking couple of weeks of extra material we supplied. There was some one-time buy opportunities. Are they still continuing this quarter as we get to the end of the quarter?
I was trying to understand, we had 13 launches during the year.
Yeah.
They should have started picking up some share. Last quarter you did 53%, and the understanding would have been that these would increase market share plus some more new launches.
Yeah.
55 seems a very conservative number as a base business.
Yeah. You know, I think with what's happened to us the last year and, how the export price erosions. This is a number that I'm comfortable with. Yeah, ideally it is a conservative number, but, let's see how it goes.
Okay, fair enough. Secondly, on the Aleor business, in one of the presentation slides you have given, you know, the with and without Aleor numbers. ex-Aleor is currently, despite some high single digit launches, zero sales. I could not understand that piece.
No, there is a sales.
Yeah. There is a sales, Prakash, and there's a sales of, you know, INR 35 crore for the year actually. Maybe because in large millions you may not be able to see that, but there is a sales in current year.
Okay. No, I can see this slide. I don't know, there's no slide number. It says Q4
Are you referring investor presentation?
Yes. It says INR 14.16 billion with and without Aleor. Both are. Impact is 0.0.
Because that is considering both consolidated numbers, then what we need to compare is between the standalone and consolidated, then you'll be able to see that. I'm giving you the figure.
Okay. That is about INR 36 lakhs.
Crore.
Crore.
Crore. Okay. Crores. Okay. Given the cost base, that would be, I would presume, it is loss-making at the moment.
Yes.
Okay, fair enough. The second question was on the R&D side. Since now it's a part, you know, subsidiary, what is our R&D guidance for the year?
If you see on the R&D side, the total number one million just now, without the one-offs that, you know, this year we ended up with INR 640 crores one-off. INR 640 crores standalone Alembic, R&D next year. Guidance should be about INR 700 crores. That would include, Aleor R&D as well, not the one-time items, which is just a pure R&D item.
Okay. With your sales,
We have to start charging off the entire R&D credit P&L item. We will stop this practice of capitalizing it and then amortizing it subsequently.
Yeah, fair enough. As a percentage to sales, that number then would look lower, right? I mean...
It depends on the sales, no?
Yeah. I mean, assuming India double-digit growth and U.S. you are saying already recovering.
You know, we don't really guide for the percentage of sales. That is an absolute amount I'm giving. I think, yeah, if India grows, everywhere everything grows, then yeah, the percentage will come down.
Okay, perfect. Lastly, if you could share some broad level guidance for the India business, because we had a high base Q1 last year.
Yeah. I think I've always maintained. I think whatever the IPM growth is for the quarter, we should expect a few basis points higher than the IPM growth. Okay, I'll answer in two pieces. Yes, there's a large impact of last year's April and May stocking that happened due to the COVID phenomenon. I think as long as the market stays robust, I think we should be able to grow a little bit faster than the market. With that being said, as it's all or as it so much in overall sales did have extremely large tailwinds in May and June, sorry, April and May of 2021, 2022. Yeah, that would be a drag on the sales. The ex of these two products, we expect the portfolio to perform relatively similarly.
Okay. Thank you.
Thank you.
Thank you. The next question is from the line of Damayanti Keray from HSBC Securities and Capital Markets. Please go ahead.
Hi, thank you for the opportunity. I just wanted to understand Aleor-related costs better. I think you mentioned now all R&D will be expensed. First, like how much of Aleor R&D has been capitalized so far? Going ahead, you mentioned like R&D will move up from around INR 640 crore-INR 700 crore for next year. Similarly, what kind of incremental cost we are expecting above EBITDA ex R&D due to this ownership change for Aleor? That's my first question.
Cumulatively, Aleor accumulated R&D expense which was capitalized in IP or R&D in excess of INR 355 crore. We have expensed out INR 180 crore in this year, FY 2022. That's question one. Question two is our annual R&D expense that we have now is about INR 50 crore, which we will have charged off in 2021, 2022, and we'll charge it off from 2022, 2023 onwards fully.
Sir, you said INR 50 crore R&D will be additional coming up from FY 2023 fourth quarter, right?
Yes.
Okay. Sir, I just missed, like how much you said total R&D capitalized for Aleor?
Three hundred and thirty-three crores.
INR 315 crore. Okay. My next question is on India business. Obviously, you mentioned like traction has been very strong. Can you clarify a bit like what factors have helped us in achieving such industry-beating growth? For FY 2023, what are your expectation on growth contributions from the volume growth as well as from the price increase part?
I think, in terms of India business, like I've been saying it now for quite a few calls, we've done significant corrections across the board in terms of our business, and it's hard for me to get into all the things we've done over the last, four years, five years to get to this. If I could just simply put it, I think, the transitioning of the product portfolio to a more high growth, profile for sure is a big one that's helped us. I think along with that extremely, robust and rigorous efforts that we put into our supply chain in the market to optimize that. You know, that has given us strong results.
Along with that, I think a large amount of the correct manning in the business and entrenching of the right manpower, right kind of profile of manpower. I think these would be the three very macro reasons. Going forward, I think there's no guidance as such that I can give, but, I think what I can say is that, you know, whatever the market performance, I expect us to do, you know, a certain amount of basis points significantly better than the market growth on any given quarter. That, that's what we're working to at this point in time. If over the next couple of quarters we can establish this trend line, we'd probably give a guidance at the end of the year to see if we can look at a far more higher percentage of growth over the IPM.
Just a clarity. The NLEM hike which was allowed from April first, that's all, like taken for your-
The volume and the product on the volume versus price growth, I think, Ajay, what's the guidance that we're giving on this? It should be anywhere between a 70/30 split, 70 on volume and 30 on price.
Yes.
Okay. 70% contribution from the volume growth and rest, 30% from the pricing hike.
Price. Yes.
Okay. Thanks. I will get back in the queue.
Thank you. The next question is from the line of Yash Gupta from Angel One Limited. Please go ahead.
sir, first of all, this INR 35 crore of Aleor business is for the complete year FY 2022 or the quarter?
For the complete year.
Sorry, not urgent. Can you please repeat, sir?
Full year.
For the full year. We have 13 launches in FY 2022. How much of the 17% growth is attributable to the new launches? Any thoughts on the price erosion in FY 2023?
We don't give a breakup of how much of the growth came from the new launches. Strategically, what Alembic does, as you know, is whenever there's a market, we slowly pick up market share. We don't get market share right away, so we gradually pick up market share in our products. As we get more confidence, as the buyers get more confidence in our supply chain abilities, we gradually pick up share. We don't give a breakup of from where we got it. Number two, what was the second part of the question?
Price erosion in the
Price erosion is tough to say because, you know, they're coming off high base of last year. I think if you look at it sequentially, I would say about 5%-10% or something like that.
Okay. For the Indian business, sir, have you taken any price hikes in the April month related to the NLEM? Any numbers that you would like to give?
I think at the moment we are still. We've taken certain parts of the portfolio, we've taken a price increase, but we don't expect that to play out immediately. As you know, there is some amount of manufactured inventory that we have in our warehouses. By the time we extinguish that inventory, it will play out maybe in a month or two in terms of price increases.
Okay, sure. Thank you, sir.
Thank you. The next question is from the line of Tarang Agarwal from Old Bridge Capital. Please go ahead.
Hi. I have just a couple of questions on some of the key products. Read about a Spiriva settlement with the innovator. When could we see this launch happening?
For which one?
Spiriva.
uncertain.
Actually, you know, we are not disclosing products which are under settlement. You are right, the product has been settled, and we hope to launch at the time of market formation.
When is that likely to be?
It's not like we are not able to give exact date at this time, because of confidentiality provisions, but it's not in the near term.
Okay, got it. Second, given that uncertain is, you know, it's synthesized, how is the market fragmentation? Because I see there's a lot of players there. How big could this opportunity be?
I think still early days. We did launch a product, but I think it's a lot of competition, so I don't expect it to be a very large and meaningful launch for most people. Still early days. We're just waiting to see what happens. We picked up some shares. We haven't gone after any of the big accounts.
Got it. Last, there's a product for which you received tentative approval in January. It's called Vumerity®. If you could just give us a sense what's happening there in terms of litigation with the innovator?
uncertain , I think in the public domain, you will see that there was a litigation going on. We generally expect, you know, the launches to happen only after patent expiry.
Okay. Got it. Yeah. Okay. Thanks.
Thank you. The next question is from the line of Vaibhav Ojatia from Honesty and Integrity Investment. Please go ahead.
Yeah. Thanks for the opportunity. I have two, three questions from a longer-term perspective. Firstly, we have been repeatedly highlighting that we have a very nimble supply chain, and whenever there are opportunities that arise due to market dislocation, we are in right position to capture it quite fast. What exactly we have done to be in this, you know, good position that we are able to capture the opportunity? Like, is it like we generally have more inventory as compared to competitors? Or is it like our manufacturing equipment are more flexible to quickly shift between the different kind of production? What are exactly the three, four things that enables us to be in this good position?
Thanks. Yeah. I think that's one of the focus areas that we've wanted to build on for the U.S. business because it's an important area we realized. You mentioned some of them. A few things that we do is I don't know compared to the competition, but what we do internally is if we do pick up an account share, we do carry extra inventory. We carry extra all the way starting from the API or the intermediates to the finished products. We carry some extra inventory. We have multiple multipurpose plants, so it helps us to be more nimble. We try to leave some capacity idle, so that helps us scale up very fast if there's a market share buildup.
I think, all the way from the front end to the back end, there's very good communication and everyone is aligned towards that, and that's what helps us.
Got it. Secondly on the international US business particularly, you know, even if we exclude the one-time benefits that we get in different forms at different point of time, even our normal international business seems to be generating a reasonable sum of money. In spite of it being, you know, a lot of products have been commoditized, and it is well-known that there are more than six-seven competitors for these kind of products. In spite of that, not only you, but a couple of other competitors are also making reasonable amount of money.
Why it is that, still this is, a reasonably attractive business in spite of lot of being, I mean, excluding the one-time opportunities, most of the products have been commoditized. In spite of that, we continue to earn good money. What in your view is the reason behind that?
The reason that drives it. It's. Listen, I think that, and I've always said that one of the reasons why the U.S. market is attractive, not just for Alembic but for everybody else, is it's a large market, right? While India is a very steady market, and you can grow at market. Like as Shaunak mentioned earlier in the call, that there's a market share growth, and you have to either to better than that or less than that. You get restricted to that band, right? For the U.S. business, there's a big opportunity to add business very fast. If you see classic example is Alembic, and up until last year, we were a CAGR of 25% in a five-year period.
You can add a lot of business, and that's why the U.S. business is still attractive. One-time buyers always help you with, helping your margins and they help the profit. Long term, in terms of supply, steady supply, it's a good market to be in. There has been more price erosion as everybody else, all our peers in the market have said, so it's made it a little less attractive. Our long-term view is it's still an interesting market and we're still focused on it.
Generally, I know, I mean, nobody has said this number, but ROC on the international business would obviously be lower than domestic. Do you think it's still in the range of, say, you know, 15%-20% or it's below that?
Yeah, like ROC on domestic business is very high. Primarily because the investment needed for domestic business is limited, and you get a high possibility out of it. As far as international business is concerned, till, as I said, till 2021, we were making a decent ROC even on international business. Two things has pulled down our ROCE in recent time. One is the investment which we have done, which has not started contributing revenues. And the second is some profits have been chipped off. As of now, that's. As a company, we are still good on ROC, particularly if you exclude the projects related profits, because again, they are still not fully generating.
If I exclude the CWIP or the projects that have not contributed the revenue, international business still have the reasonable ROC? That's what you're saying, apart from the?
Reasonable is a state of mind, and what is reasonable, there is no definition. We still have more positive ROC.
Okay. Okay. Got it. Thank you, sir. That's it from me. Bye.
Thank you. Reminder to all the participants, to ask a question, you may please press star and one. The next question is from the line of Ranvir Singh from Sunidhi Securities. Please go ahead.
Yeah, thanks for taking my question. Just wanted a clarity on U.S. business. In this quarter, we had, you know, better than the normal run rate that the aggregate run rate we had. What was the reason, that particular launch of respiratory products, that was the only contributor?
No. As I mentioned earlier in my opening statement, one of the reasons why the US did well is we picked up market share in our existing portfolio. I think I've been saying it for the last two, three quarters. We're gradually picking up share in some of our products. That is one reason. Number two, there were some one-time opportunities that we saw in the U.S. market, some short-term, so that has picked up the sales. Third is, we've moved distributors in the U.S. Still some inventory restocking at the distributor level. We carried some extra inventory at the distributor level to facilitate the transitions for them.
Of that INR 10-12 million would have been in a nature of exceptional upside, right?
I wouldn't like to give a breakdown of each of the sales, but it will be because of all three, because part of it was increased market share and part of it one-time buys.
Okay, fine. Secondly, just on integration of Aleor. What was the operating cost related to Aleor in this quarter or for a year, if you can give?
We have R&D cost of around between INR 40 crore-INR 50 crore, and the plant is very efficient. It runs around, you know, less than INR 40 crore.
Of that INR 188 crore, excluding that INR 65 crore in amortization, the remaining INR 123 crore, of that INR 123 crore, which is above EBITDA, so that includes-
Ranvir, please, we can take this question offline, and you know, you can call me and we'll discuss this.
Okay. Sure. Just last one on another side. That on CapEx, so what in FY 23 we can expect?
In terms of CapEx, Vijay?
CapEx for 2023 would be around INR 450 crore. That would include the pre-operative expenses for the plants.
Including pre-operative expenses.
I think, yeah, including.
Okay. Yeah. Thanks a lot. That's it for now.
Thank you. The next question is from the line of Ashwini Agarwal from Ashmore Investment Management. Please go ahead.
Hi. Good evening. On Aleor, in response to a previous question, you said that the capitalized R&D was INR 355 crores, of which INR 180 crores has been expensed off as a one-off. Is there a plan to expense off the remaining INR 175 crores as well?
Yes. As I said, actually, the Aleor, as of now it still remains a separate company, though we plan to amalgamate it. They have decided to accelerate the amortization. I believe the rest of the accumulated R&D, they amortized in FY 2023.
Okay. INR 175 crores will appear as a one-off in fiscal 2023.
No, 50. INR 55 crore.
Okay. Sir, obviously, you know, this business is incurring a fairly substantial loss at this point in time and, you know, we have a number of filings in there. Could you help us build a picture about how we should look at Aleor over the next three-five years? I mean, you acquired the minority stake of 40% in this and you're amalgamating it in the holding co. I mean, how do we think about this business from a three-five-year perspective?
In my opinion, the best way to look at it is, it's separated now. I think moving forward it's just gonna be amalgamated into Alembic, and there's not much to see, right? Because even on the R&D side, as I mentioned, the ongoing R&D cost will be about INR 50 crore a year compared to about INR 650 crore that we have in Alembic. It's a small fraction. We've filed a bunch of products, over 30-odd products that they've got, and they'll just get amalgamated with Alembic. The plant is running quite efficiently and, you know. Moving forward after the amalgamation, I don't think you should look at it separately. It's just like a derm portfolio for us, because cost-wise it's not gonna be any major issue for us.
No, no, that's not the point. The point is that last year you had revenue of roughly about INR 33 crore, right? Against which you had an R&D expense of about INR 50 crore and plant operating expenses, if I got the number right, another INR 80 crore or so. Correct?
No, all put together was INR 80. The plant would be at, yeah, I mean, around INR 30-40 crores.
INR 30-40 crores. I mean, it's a straight loss of about 50 crores. I mean, now obviously while it will be a division and it'll be a number that will get hidden away in the big picture of things, but I just wanted to understand the rationale for acquiring the minority stake and what do you expect this business to contribute over a period of time? You know, the fact that it'll be small is not relevant, right? The fact is that it
The rationale is, it's the same as it is for the rest of the U.S. business, right? We are still excited about the U.S. business, and this is a good portfolio to have. There are some opportunities in derm as well. I do see the sales also ramping up significantly. There's a lot of approvals that will be coming in this plant. Cost-wise, the plant is a very efficient plant. I think it's going with the U.S. strategy, right? That we're excited in the U.S. business and this one too is will add to that. Sales and profit, everything will go up with this.
If I recall right, the total capitalized value of Aleor as of 31st March 2021 was of the order of INR 800 crore. Am I right?
Correct, sir.
Out of which, let's say INR 355 crore gets written down as R&D. That leaves you with something like INR 500 crore ballpark. Would that be correct?
Yeah.
Would it be reasonable to expect that over a period of time, this INR 500 crores can turn out an ROC of double digits, or would that be too aggressive?
No, I think over a period of time, yes, we expect it to have that level of return on ROC.
Okay. All right. Thank you so much.
Thank you.
Thank you. The ne xt question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Yeah. Hi, good evening. I just, you know, on the U.S. market, you know, this quarter seemed to have, you know, created certain opportunities. What is driving it? Is it the China-related shutdown? You know, why are, you know, distributors talking more? Why are those opportunities coming back? Is there any structural shift or this is just,
No. Yeah. Saion, there's no structural shift per se in the market. I think for the last few quarters I've been saying that, with the erosion rate, excuse me, we're looking at building up more market share in some products. We've had that. That's one aspect of it, where we've gained market share in some products. Number two is there were certain one-time buy opportunities. I don't think they were China related. It was just, basic, whatever reason the market was short on these products. That was the second one. Third, as I mentioned, the distributor, I think that is more only for us because we are moving our TPL, our third party distributor, to a new distributor. We moved on the first of April.
Hence, we wanted to stock up some more material to ensure there's a smooth transition. That's all. Structurally, there's no shift in the market per se. I don't think China disruption is something that we've seen so far on the formulation side in the US.
The second question is, I mean, you know, when you think such slightly long term in the U.S., you know, you mentioned it's a market which you feel excited about, but it appears that, you know, most of these opportunities are very much sort of one-off in nature, which is very unpredictable. So how you make, you know, capital allocation decisions based on such sort of uncertainty?
Yeah, you know, I think like what we've seen historically with the US market, it does move up and down. There are opportunities always. As I said earlier, it's like a massive market size. You know, while the returns have come down considering what we thought initially, but we're being mindful of it. That's why if you see R&D, what I said earlier, that R&D also for next year, we're gonna keep R&D flat for next year. If you do your job well, is to remain compliant, you will get opportunities as we've seen time and time again.
Okay. Any other new areas of, you know, you are looking at, for the U.S. market? I know your topicals, injectables or solids. Anything else, you want to sort of-
I think as of now our hands are full with what we've got. I think our first priority is to ensure the injectable plant is compliant. We will resubmit our response to the FDA. We're undergoing remediation right now, and we've got consultants. That's the first aspect, because once that comes in, automatically the ophthalmic line, the regular injectables, the prefilled syringes, the long-acting injectables, everything then kicks into play.
Okay. Just one final question from my side. On the cost front, sir, if you can just you know throw some light on how the raw material, logistics and other overhead sort of costs are trending. I just want to know where we are versus, let's say, what we had seen maybe, you know, pre-pandemic levels, just to get a sense on, you know, how elevated the costs are for.
This year the logistics have been a big hit for everyone, I guess, in the industry. It was all the shipping rates, not just air, but even sea has gone up. I think we moved a lot of our shipments from air to sea, but in spite of that, we've seen a higher logistics cost. Mitanshu, actually you have the number. Do you want to throw a number on that?
Yeah, I think on material cost we are stable, so there's no significant change in the quarter on pre-pandemic is old story. I don't remember the number, but certainly I don't expect a big movement.
Yeah. I think mostly we call them some intermediate, some chemicals have gone up. Rest I think is okay.
Is it possible to give a number like, you know, so many crores, let's say?
I can give you details. Sayan, can we discuss offline? Like, you call me and we'll discuss the numbers.
Okay. Sure.
Thanks.
Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead.
Yeah. Hi. Am I audible?
Yes, you are, sir.
Thanks for the follow-up. Just one question. Like, you know, since Aleor is loss-making and, you know, derms are little bit kind of getting commoditized, you know, was there a thought process of, you know, selling our stake rather than buying, you know, the other stake?
To be honest, no, I don't think that I, as I mentioned, I think it's an interesting market, so I didn't want to sell our stake. I think it's, you know, a compliant plant that's approved four, inspected four times. There's a nice portfolio, and it's a good basket of products, so I was quite keen to pick up the balance 40%.
Okay. What's the pipeline like? I mean, how many filed and how many pending?
We have total 45 products that we are working on at this point in time. There are others under consideration, but 45 in the grid. We filed 30 of that actually, and we have 17 approvals, and we have launched 11 products.
Okay. These seven products are currently giving us $5 million?
Y-yeah.
Okay. These would be just launched, right? I mean, there is a chance of they becoming little larger, right?
Yeah.
Hello?
Yes. Of course. Yes.
Okay. Secondly, on India business, since, you know, growth is across the board and more so acute, but things will normalize. Just trying to understand, I mean, in the past we have invested, the capital allocation is higher in the export business. Having done that now, is there, you know, an M&A strategy for India? Any thought process there?
Yes. On the India piece, I think on the M&A side, you know, like I said, not scouting, but we keep a check on what's going on. I think at this point in time, looking at the last valuation or the last three transactions with the India business that have happened, including the veterinary ones, I think at this point we see limited value, rather, we see limited long-term value in any M&A strategy at this point in time to pick up our entire portfolio. I think what we are constantly trying to do is we're trying to augment the portfolio, and I think we have certain slots in certain divisions or certain therapeutic areas where we can look at acquire or whatnot. We know those transactions are quite slow and long drawn and, you know, success rates are very low.
Yeah, that is what we are looking at. As of now, I think jumping in the play for any M&A asset that comes up in India, I think that's not something we feel is a proven strategy for an Indian company like us.
Okay, fair enough.
I think the reason why I say this is I think where we are. I think we've been able to demonstrate now it's been quite a few quarters. We've been able to show sustainable predictability and decent growth numbers. I think there are plenty of ideas. There are plenty of things at an organic level where we want to actualize that. I mean, from a resource allocation point, yes, we have stepped up resource allocations little bit compared to what we were doing two, three years ago. But there are a lot of ideas and there's a lot of clarity in terms of what can give us this additional incremental growth in the India business over and above what we're doing at this point in time.
Hopefully, we can execute these in this year, and some of that should start showing in the end of the year.
Okay, lovely. Lastly, I mean, was there a comment on our partnership with Rhizen? I mean, on umbralisib, where are we? What are the next steps? If you could just give us a year-end overview and going forward how.
Yeah. No, there was no comment on it. It's disappointing news that we saw and maybe some of you saw that the FDA has taken a very different view towards all PI3K inhibitors products in the market. TG or they've volunteered out of that ODAC meeting. What we know is in the public domain of TG, we will start discussions with them on what they see. What we know in the public domain of TG is that they are not gonna pursue oncology as much or they're not gonna pursue oncology in the future. We're in talks with them. Let's see how it goes. It is indeed disappointing because it is at the last leg and they took this call.
For PI, not for distributing the product, but for PI3K inhibitors.
Yeah. Then you have the chance to go and scout for another partner or how does these things happen?
It's, as I said, we're in discussions with TG. Let's see what happens. We are in talks with them, so next couple of weeks we'll get an idea.
Okay. Is there any near-term milestone that was pending?
No, nothing pending.
Okay, got it. Thank you and all the best.
Thank you. The next question is from the line of Dharit Sheth from Equirus. Please go ahead.
Yeah. Hi. Thanks for the opportunity. Sir, just wanted to understand on the domestic market, considering our product Azee has crossed the INR 50 crore mark. Do you think going forward for at least next one year, our growth could be in double-digit for the Indian market? Or do you believe it could be less than 10% in that case if it normalizes?
Hello?
Yeah. Sorry.
Yeah. Sorry, my connection was bad. Can you just repeat the question please?
Sure. Sure.
Actually, I was asking since our product Azee has crossed INR 40 crore mark for this year, which could actually normalize going forward considering the COVID cases as well as all the 50 cases have come down drastically. Do you believe we can grow in double digits even going forward in FY 2023?
I think this year, like I mentioned, I think with some amount of a higher base, this year, I think growing at a double digit for this current year, sorry, 2022, 2023, I think would be a bit of a challenge.
I think going forward, I think 2023 onwards, we should come back to historical growth number that we've been giving pre-COVID, which is, you know, anywhere from a low- to mid-level double-digit growth based on market growth numbers.
Sure. Sir, just wanted to understand on the U.S. part as well, considering we have got additional set of queries for the new facility. How do we look at U.S. market from FY 2023 perspective in the absence of new plants, considering the new product approval which we have seen is having a ticket size of around $30-$35 million. In the absence of new facilities coming through, how do we look at the U.S. market for FY 2023?
Well, there is two parts to it, right? I think we are still going ahead launching. As I mentioned, we will launch about 15 odd products in the U.S., in FY 2023. That will help the growth as well as what we saw in Q4, that we picked up share in some existing products as well. 15 products is pretty good, and I think we should be able to get growth on these products. In the next six months, nine months, depends how long it takes for the FDA, we'll get an idea about the new facility as well. Growth will continue because we have a non-injectable portfolio as well.
Right. I just wanted to understand one part. Considering our overall, we have got our settlements of Revlimid. How is the scheduled launch schedule? Are they going to be at the time of market formation in the second wave or third wave? How is it going to be?
Sorry, the question was on Revlimid?
Yes.
Revlimid, I think what's in public domain is that we are in litigation with the brand, the innovator. You know, that's all we can say. Basically, it's a pretty early stage in litigation, so we'll see how that progresses.
Oh, okay. We have not yet settled it, right?
No, we have not yet settled.
Right. Last question. You said 15 launches. Out of that, how many are going to be the ones which we had got already approved in FY 2022 and will be launching in FY 2023?
I don't have an idea.
No. Overall.
How many are approved and how many are? Oh, I'm just saying 15, but that's what I expect to launch, you know. See, because always we don't launch. We sometimes take some time to launch a product when we say market formation, where we wait. It's an opportunity. We will launch 15. Some may be from this last year, some may be kind of pending with us for a while. It depends on the certainty.
Sure. That's helpful. Thank you, sir. Best of luck.
Thank you. Ladies and gentlemen, due to time constraint, this was the last question. I now hand the conference over to Mr. R. K. Baheti for his closing comments. Over to you, sir.
Yeah, thank you. There were a couple of pending questions that I think we have some other schedule. So you can get in touch with anybody whose questions are not responded to. Can you check with Deepanshi or Ajay, we'll be happy to share that information. Thank you very much everyone for joining this call, and it's always interesting to chat with you and look forward to see you again next quarter. Thank you.
Thank you. Thank you, members of the management. Ladies and gentlemen, on behalf of Alembic Pharmaceuticals Limited, that concludes this conference call. Thank you for joining us. You may now disconnect your lines.