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Aurobindo Pharma Ltd
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Ladies and gentlemen, welcome to quarter 1 FY '23 Earnings Conference Call of Aurobindo Pharma Limited. [Operator Instructions]
I now hand the conference over to Deepti Thakur. Thank you, and over to you.
Thank you, Aditya. Good morning, and a warm welcome to our first quarter FY '23 earnings call. I'm Deepti Thakur from Investor Relations team.
We hope you have received the quarter 1 FY '22 financials and the press release that was sent out yesterday. These are also available on our website.
I would like to introduce my senior management team today on the call with us, represented by Mr. P.V. Ram Prasad Reddy , Chairman, Aurobindo Pharma USA; Mr. K. Nithyananda Reddy, Vice Chairman and Managing Director of Aurobindo Pharma Limited, Mr. S. Subramanian, CFO; Mr. Sanjeev Dani, COO, Head Formulations, Aurobindo Pharma Limited; Mr. Yugandhar Puvvala, CEO of Eugia Pharma Specialities Limited; and Mr. Swami Iyer, CFO, Aurobindo Pharma USA.
We will begin the call with summary highlights from the management followed by an interactive Q&A session. Please note that some of the matters we will discuss today are forward-looking, including and without limitations, statements relating to the implementation of strategic actions and other affirmations on our future business, business development and commercial performance. While these forward-looking statements exemplify our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and important factors may cause actual development and results might vary materially from expectations. Aurobindo Pharma undertakes no obligation to publicly revise any forward-looking statements to reflect in future events or circumstances.
With that, I will hand over the call to Mr. S. Subramanian for the highlights. Over to you, sir.
Good morning, everyone. I hope that all of you and your families are safe. We are here to discuss the results of the first quarter of the fiscal year FY '23 declared by the company. For Q1 FY '23, the company registered a revenue of INR 6,235.9 crores, an increase of 9.4% year-on-year. The EBITDA before ForEx and other income was INR 964.7 crores, declined by 1% quarter-on-quarter. EBITDA margin for the quarter was 15.5%. Net profit decreased by 9.6% quarter-on-quarter to INR 520.5 crores.
In terms of the business breakdown, Formulations business in Q1 FY '23 witnessed a growth of 9% year-on-year to INR 5,329.4 crores and contributed around 85.5% of the total revenue. API business contributed around 14.5% of the total revenue and clocked a revenue of INR 906.5 crores for the quarter, registering a growth of 11.6% on a year-on-year basis, led by improved demand for some of our key products and declined by -- declined at 0.7% quarter-on-quarter.
On a constant currency basis, U.S. revenue increased by 6.1% year-on-year and 6.2% quarter-on-quarter to USD 386 million. We have received final approval for 10 ANDAs and launched 7 products in the quarter under review. We have filed 13 ANDAs, including 4 injectables during the quarter.
Revenue for Aurobindo Pharma USA, the company making the overall products in the U.S. has increased by 5% year-on-year to USD 214 million. Revenue for AuroMedics, the injectable business, increased by 16% year-on-year to $71.7 million. The company as of 30th June '22 as filed 741 ANDAs on a cumulative basis, of which 516 as final approval and 35 as tentative approval, including ANDAs, which are tentatively approved under the PEPFAR and the balance 190 ANDAs are under review.
For the quarter, the European Formulations revenue clocked INR 1,548.1 crores, a decrease of 2.2% year-on-year, mainly due to the depreciation of euro currency and in absolute euro terms, the Europe revenue was at EUR 189 million with an increase of 5.9% year-on-year. For the quarter, the growth market witnessed a growth of 30.8% to INR 430.6 crores, including the domestic formulation sale of INR 45.6 crores. The quarter performance was led by strong growth in Canada business.
For the quarter, ARV business stood at INR 379.6 crores with a growth of 28.1% year-on-year. And in U.S. terms, yearly revenue was at $49 million with a growth of 23% due to shifting of certain sales from the last quarter to this quarter amounting to USD 17 million.
R&D expenditure is at INR 310 crores during the quarter, which is 5% of the revenue. Net organic CapEx during the quarter is $61 million, an average ForEx rate of INR 76.9795 in the quarter ending June '22 and INR 75.0917 in the quarter ending March '22.
Net cash and investments at the end of June '22 was USD 337 million. The average finance cost is 1.8%, mainly due to earning multiple currencies. The business generated a free cash flow before CapEx and other items of USD 121 million during this quarter. Out of this cash flow, USD 53 million was spent towards the CapEx, another $8 million was on PLI project and USD 34 million for dividend and USD 22 million for acquisition of business and thereby increasing the free cash flow by -- net free cash flow by about USD 3 million.
As a result of the above cash flow generated during the quarter, the net cash position, including the investments at the end of March '22, improved to $337 million. Also, we reduced the gross debt significantly to $277 million from $313 million in March '22. We have been reducing the gross debt quarter-on-quarter in the past quarters also. This is all from our end, and we are happy to take your questions now. Thank you.
[Operator Instructions] First question is from Mr. Prakash Agarwal. Please unmute yourself, Mr. Prakash.
Am I audible?
Yes.
Yes, apologies. So the first question is, obviously, you did fairly well in the U.S. market, which has shown a Q-on-Q growth. Is it -- our preference is volume versus getting into better pricing given the gross margin decline, our gross margin is largely due to the cost inflation? Or we have gone for volumes in the U.S. also to grow the business?
Okay. I can take this, Subbu. In the U.S., we have grown the volumes compared to the last year similar quarter. And we have taken on fair amount of business. We have then grown in terms of volume, and the bottom line has various factors. One of the main reasons is the price erosion. And there has been inflation also in terms of transportation. We believe that going forward, we can look for better numbers in terms of gross margins for the years.
And when you say price erosion, what kind of price erosion we are talking about here, it is in line with the previously seen trends of 5%, 7% or it is as reported by some of the peers, it's double digit? Or how are we facing -- what is the trend we are facing?
I think we are seeing some kind of tapering. We believe that the price erosion, for example, this quarter compared to the previous quarter is about, I would say, 2% plus throwing in the shelf stock adjustment also, it's close to around 3%.
Okay. Okay. Okay. And what about injectables? I mean that growth doesn't seem to pick up. So what's happening there?
I think Yugandhar can take this question.
Prakash, I think in terms of the growth, like we have grown by 16% in U.S. and the overall growth is in the single digits at the global level. And we expect whatever approvals what we received during quarter 1, and we expect some more approvals to flow through in this quarter. We are very confident of hitting the double-digit growth for this year. The growth is not a concern at all.
But we have a big milestone, right? I mean we have talked about almost doubling the business in the next 2 years. So where are we in that journey?
It is -- we are still on track to hit the guidance what we have given for FY '24, which is $650 million to $700 million. And as I indicated last year, we closed at a pro forma level of around, in FY '22, around $440 million, and we expect to cross $1 billion this year in FY '23. And we are on track for our guidance for FY '24.
Okay. So you are saying it would be largely back-ended? Or how should we think about in terms of scale up? I mean...
No, it won't be back ended. It will be a quarter-on-quarter growth and -- which you will continue to see the double-digit growth every quarter.
Okay. Fair enough, fair enough. And one question for Subbu sir, is on the gross margin. So clearly, the price erosion is very -- I mean, I would say, stable, 3% is stable in my view. But how -- what is the outlook on the gross margin from here on, given we have seen a substantial drop in this quarter?
I think the same 3% already -- overall, if you really see the gross contribution has come down by about 2.8%, which is a combination of multiple factors, including the price erosion, which Swami has mentioned, and there was some raw material price increase also has happened. I mean, even though the price started becoming stable, but because of the weighted average, some of the cost, which has not been charged off earlier is coming this quarter, right? So all put together, around 2.8%. And we believe going forward must be in this range in the coming quarter and probably there must be softening coming in the Q3. We are getting some indication, but not from everyone. So we can -- if at all, we can see, we can start seeing the improvements in the margin in Q3 onwards. That's what my feeling, right? I'm talking about the gross contribution. I'm -- gross margin, not the EBITDA margin, okay?
Okay. Any color on EBITDA margin, sir?
See, EBITDA margin, even though this quarter, it looks like low. We had one-off expenditure to the tune of -- I mean, instead of one-off, I would like to use a word additional expenditure to the tune of around INR 60 crores on account of the freight because we have to reschedule our production process, et cetera, to meet certain regulatory compliance because of the production shifted to the later part of the quarter, which made us to airlift the material to achieve the commitments we have given to our customers.
So going forward, this should not be there in the coming quarter, or at least at a very reduced level it should be. That's what our feeling.
1 or 2 [indiscernible] will be there, Subbu. Last quarter and this quarter also some extent is there. Then it will taper down.
Okay. And last question for RPR sir. Is there any update on the -- we had Govind sir, as a CEO. So is there any update on looking out for a professional CEO going forward?
As on today, we are not looking that -- we are happy with the present system. And we have the -- for all -- as we told in the last call, biosimilars and vaccines and in peptides, Dr. Satakarni is the CEO and Yugandhar is taking care and Nithyananda is taking care of the overall and raw material business. I'm taking the Formulations and reporting to Nithyananda. That is what -- and I don't think we are looking, but it will take -- we are going to appoint in next 2 to 3 years on.
Next question is from Neha Manpuria.
Am I audible?
Yes, very -- a little bit feeble. You can talk a bit louder.
Yes, Neha. Go ahead.
It's going into mute.
Yes, she is on mute.
She has muted herself. Neha, please unmute yourself. Okay. We'll take the next question. Next question is from Shyam Srinivasan.
Can you hear me?
Yes.
Okay. So just I missed a little bit of the opening remarks. So just on U.S. revenues, I think we talked about lower price erosion, but Q-o-Q and Y-o-Y, we have grown. So what's driven that, new products -- new contracts and old products, if you can help us understand?
Swami?
Sure. So Shyam, one is we have done additional volumes across some of our business. First and foremost, we had some supply chain constraints, so we could not bring in those kind of volumes. And this quarter, there's been an improvement in terms of volume. So the demand for those products were good, so we could increase volume for those products. And apart from that, we also tried to get some of the business -- base business additionally. So we have been partly successful in that.
Generally, second and third quarter, some seasonal products also will improve, basically like antibiotics and those things. This is also another reason this demand will increase second and third quarter. And then other thing what Swami is telling.
Got it. Swami, and RPR sir, but the volumes came at much lower prices because the gross margin comment you made on pricing pressure, is it U.S. only or we have seen it elsewhere as well?
Swami?
So Shyam, the -- as far as the gross margin is concerned, there is definitely a lag for improvement after these prices going to effect, there is an inflation in terms of transportation. And we have taken on additional volumes and some of the additional volume products may have product mix while the margins are below.
But like Mr. Reddy mentioned, we are looking forward to higher volume then the mix could be better. And we believe that the lag in the price changes that we have seen that might somewhat be nullified a bit going forward in the second and third quarters.
Got it. Very helpful. Second is on Europe and also on biosimilars. So Europe as a business, we've seen it -- you accounted it for FX reasons. But clearly, even here, we have seen that lackluster growth for quite a few quarters, right. So while the U.S. engine is probably slower, Europe has remained and these two are like almost 2/3 of your business. So just want to understand what's happening in the Europe front. And the linking point is there any update on the biosimilars in terms of either approval of queries from EMA, anything?
Yes, Sanjeev, you want to answer on Europe?
Yes. So Shyam, just to put it in a perspective, the Europe business is pretty stable and growing. This quarter, we had the 6% growth. The previous quarter was 7% growth, and the markets are about 0% to 3% growth. So we are expecting 5% to 8% growth year-on-year and that has been always the guidance. I mean, of course, we are not looking at double digit unless we are -- we had made in the past acquisition, then only it has grown.
Secondly, the future growth drivers are, of course, the new products. So we have several new products, which are waiting for approval, something close to 43. And we have another 118 overall products under development. Then we are looking at the oncology products, injectable and oral which are another close to 50 and injectable, the new plant, which is expected to start filing early next year that we are looking at about 50 -- close to 50 products and then biosimilar, which are 2, which are already filed for now almost 9 months.
So all put together, this market -- addressable market is $34 billion. And even considering the net price, et cetera, and then 5% to 10% market share, we are looking at about $300 million plus in the next couple of years. So I guess that the new products once they are there specialty driven, we will be able to grow faster.
Specifically, Shyam, the biosimilars, as we told in the last call, 2 products we filed in U.K. and Europe. And that is the day -- 180 days will happen in the next 1 week. There, we will have a lot of clarity where we stand. And we have filed in U.K., third product that is not the global clinical, but U.S., as we told -- as on today, we have 4 global clinical going on. And those out of that one we are going to file in the first quarter of 2023, '24 and the same year in the last quarter, we are filing second product in the U.S. So U.S., we will file 2 products. And next year, we will file total 5 products in Europe.
One data point for Sanjeev, just where are we on margins in Europe at this point of time? Still above double digit?
Yes, margins or EBITDA is in double digit -- early double digit, yes.
Next question is from Neha Manpuria.
Yes. Am I audible now?
Yes, Neha, go ahead.
Yes, go ahead, madam. We can hear you.
Neha, can you unmute yourself? Okay, we'll take her again.
Yes, we'll move to next person.
Yes. Next question is from [ Pravin Kale ].
Yes, sir. So I would like to ask a question on behalf of the retail investors, right? So in terms of our investment in the stock, we haven't seen much appreciation. What does the result mean for retail investors like us? Because we had a lot of hope on also the Eugia Pharma investment. So that did not come through. And the price of the stock hasn't been reflecting the progress that you've been making. So as a retail investor, what should I be expecting in the days ahead?
Yes, Mr. Pravin, while -- we may not like to comment on the movement of the share price or where it is. In terms of the performance, we have given a very clear road map where we are heading to on various things. And if you have seen our annual report also, we have said what are all our growth pillars which is what going to deliver it in the coming years. And I'm sure for the -- for your benefit, I'll repeat, one is the biosimilars, second is Eugia, which Yugandhar had just explained. And we are going with the PenG project. We are getting into the China project.
So, so many projects. And as on date, there are 6 plants are under commissioning, right? And once these have been successfully commissioned, this will also add to the top line and the bottom line, et cetera. So it's -- from our side, what the company and the management has to do in terms of working out a strategy to improve the top line and bottom line, we have been doing that.
Well, I really appreciate your efforts in this regard. And I do hope that, I mean, as a retail investor who has a lot of hopes in the progress of your company, you guys do really well in the days ahead.
Next question is from Anubhav Aggarwal.
Subbu sir, a couple of clarities first. You mentioned about $17 million number. Is that a shift which has happened in the U.S. segment or ARV segment?
It is in the ARV segment, Anubhav, because we follow the AS 115, revenue recognition, if the material has not been loaded into the vessel, we will not attempt the sales. Last quarter, we could not do, which has happened in the month of April. That's the reason why it got added here.
And similarly, this quarter also some -- around $5 million got deferred to the next quarter. So this is a continuous phenomenon. But since the number is a significant one, we thought better to inform the market. On an average base, the ARV business, we have been looking at, which has been explained to you in the past quarter also, will be around the $35 million at least we have been -- I mean targeting to achieve not less than $35 million quarter-on-quarter.
Helpful. Second question is just a clarity on the other expenses actually adjusted for the INR 60 crore number that you talked about, other expenses has gone up significantly quarter-on-quarter. There is a -- even if I adjust for INR 60 crores, there is a INR 100 crores jump, I understand this quarter has, let's say, integration of the India acquisition that you have done, that would have added some, but still a higher number. You...
Yes, Anubhav, see, what is happening is when you're looking into the numbers in rupee term, we need to translate all the Europe, U.S., everything into rupees, which has also added significantly. That is also one of the reason, right?
Plus, as we said in the last 3, 4 quarters, you are comparing exactly Q1 FY '22 versus Q1 FY '23. I would say because so much of freight costs, et cetera, has increased in the month of -- in the Q2 or Q3 of last year, so it is not really comparable. If I give -- demonstrate some number, the freight cost, which was there in Q1 has gone up nearly doubled in this quarter. Even though I mentioned about INR 60 crores, which is additional only pertaining to this quarter. But overall, freight cost, [indiscernible] I mean, all the expenses for everything has gone up substantially in the last 1 year, which we have been explaining in every quarter.
Subbu sir, I was not comparing year-on-year. Actually, if you look at March quarter versus June quarter, our total other expenses is almost up -- increased by INR 170 crores. So let's exclude the INR 60 crore number that you talked about. Freight costs, I am not sure how much they have increased March quarter versus June quarter?
If I'm right, Q4 other expenditure was INR 1,457 crores vis-a-vis INR 1,504 crores, which is an increase of around INR 50 crores. This INR 50 crore increase is I can clearly say the INR 60 crores on account of the freight, plus we have the India integration, et cetera. I really do not know which number you are comparing. INR 1,457 crores versus INR 1,504 crores.
I am comparing the same numbers, but in this number, your R&D has reduced by -- significantly, right, as well?
R&D is not only the expenditure. It is not the payroll employee, which is the biggest cost, we are nearly so much of payroll costs and other things. Plus, it is a personnel translation also.
But won't be -- sorry for harping on this, but would bulk of R&D be captured in other expense rather than the personnel costs?
Everything will go into -- it's spread over all the elements of cost. Like in payroll, it will be there, in other expense will be there, everywhere.
Okay. Let me simplify. Is this a new base? Just -- so INR 60 crores is an adjustment you made for this, then is it the base that we work with until and unless the freight cost comes down?
Yes. I think around 1,000 -- I mean, this is what when we said INR 1,504 crores, right, at least it has the incremental cost of around clearly INR 50 crores to INR 60 crores pertaining to this quarter alone, right? And probably the INR 1,450 crores is what we need to look at it, subject to the translation effect on account of the ForEx and other.
And R&D, we should think about somewhere between INR 350 crores to INR 400 crores range a quarter or like...
I think, that is what to see. Typically, if you really see now, as the Chairman explained, while talking about the biosimilar, we are getting into the 4 biosimilars into the clinical trials in this year. Probably the impact of it, you can start seeing it from Q3 and Q4, right? So you can see the biosimilar costs going up, right? And by the time we hope, as explained, the freight costs are a little bit softening, probably that impact may come down. And we are also trying to ensure we are moving the material more into the sea route rather than the airfreight. So we are also trying to do all the possible things by which the cost is controlled.
And just last question, $22 million that you talked about in acquisition, what does it pertain to?
This is the Veritaz, which we've explained around INR 171 crores plus GLS INR 9 crores.
The next question is from Surya Patra.
Sir, the first question on the U.S. business. And pardon me if I'm repeating this, I've joined relatively lately. Sir, there is a kind of a positive surprise in terms of the U.S. generic growth what we have seen in this quarter, despite our earlier guidance that possibly 13%, 14% kind of price erosion that we would be seeing for our base business. So -- and simultaneously, obviously, there is a kind of impact on the gross margin also that we are witnessing. So is it fair to link these 2 things and think that the growth would be possibly in the U.S. market is coming at the cost of margin because of volume push?
Surya, thank you. First and foremost, I would like to clarify, last time as Reddy had mentioned that we have to watch 1 or 2 quarters as far as the erosion is concerned. And he hinted that probably it may not happen the way it has happened, and that is kind of a factual statement. It turns out to be actually correct. We are not experiencing that kind of erosion that we did last quarter. That's number one.
Number two, with regard to the margins, the margins, there are various reasons for it. One is, of course, the increase in certain costs. I had mentioned earlier that there would be a time lag for some of the realizations or some of the savings that could happen. For example, just to tell you, the gasoline prices have gone up, so the transportation cost had shot up. And now we have seen in this quarter, the prices coming down. Naturally, that's going to translate into lower cost for us.
So I don't want to get into those kind of details. But primarily, what we are saying is, Q1, we did have certain increases in cost. And these were not matched in terms of realization. We did take a lot of volume and there could be -- quarter-to-quarter, there could be some product mix issues.
So we -- earlier, I do remember, in one of the investors call, we mentioned that you should not take quarter-to-quarter. Overall, I think we will do better.
Sure, sir. And regards this India business, [indiscernible] obviously, initially, we had indicated about the branded Formulation for it in the market. But our expectation was really low, like INR 1,000 crore kind of a base in 2 to 3 years time. So that will not influence at all our overall business model. So -- and we are currently doing small, small acquisitions to build up. So what is the ultimate plan here? And can it really be more influential positively to our overall business? If you can throw some light here, how should we think?
Yes. Subbu, I'll answer that. So Surya, I do agree on a INR 25,000 crore company, INR 1,000 crore will not contribute so much. But that is how we want to make a start because launching organically, we will not reach anywhere around even that number, so -- in the time frame that we are discussing. So we have to make an acquisition. But I guess we have to keep on looking opportunities and look at the strategic fit and also not at a very high valuation, which is the current level. So I guess that we will be spending our money or investing money wisely.
Okay. And sir, on the European operations, Sanjeev sir, so although we have been targeting that kind of a more integrated manufacturing activities in India should ultimately be driving in the overall profitability to the company levels. And I think the major trigger on that front is the launch of injectables. So there, when should really be considered this injectable ramp-up happening or launches happening in Europe and that should be bringing at least the profitability beyond 15% level because it has stuck at that level of -- 11%, 12% levels in some time.
See, if you -- not only injectable, we also talked about biosimilars. So that also will give a higher profitability margin. But I remember CEO of Eugia talking, Yugandhar, who is also on the call, talking about filing the products early next year. So I guess it takes about a year to get the product's approval. So you can look at FY '24 onwards, this impact coming. But meanwhile, some of the capacities are being expanded, so even existing approval, we will be able to meet the demand.
Okay. Just last one, a bit, sir, on the PLI side. So with the significant change in the pricing scenario of the PenG and all that, so do you think this proposition has changed meaningfully from the time of that with accepting the contract. And now the situation is becoming even more significantly better for our operation? And what is the stage of that PLI project?
Surya, just to address, the status of the PLI project is the project that's already started and will be expected to install the entire thing by about maybe Q2 and then do the pilot batches, et cetera. Hopefully, we'll be completing by Q4 2024 -- I mean Q4 2024. And we are expected to commission the project as of 1st of April 2024. That is what we have seen. While our endeavor is to complete it earlier, but this is the target which we have been working on, right? That is one thing.
In terms of the prices, I think we are 18 months away from the commissioning date, and we will not like to make any statement depending upon the current price, et cetera. So let us phase it as and when it comes nearer the date. But yes, that is a positive, but whether this is a sustainable pricing, et cetera, we do not know at this stage.
Subbu, it is not only pricing, the input costs also the PenG has increased like [indiscernible] increased, power increased and all these things, the increase in the price also because of the costs also are increased with something.
Yes. Or input raw material and the...
We are going to complete the plant before December '23, and we are going to start before March of '24.
Next question is from Nitin Agarwal.
Sir, my question is on the -- on your China business, can you just give us more update on where we are in the China business in terms of the meaningful commercialization revenues coming in from there?
On the China business, as we told, the plant was completed. We have taken around 11 exhibit batches. And the filings will start from October onwards because 6-month stability we have to put. Because the revenues will start in [indiscernible] days, any Formulation plant, after you complete the plant, it is taking 5 years to become the commercial production because commercial production means you have to take the products, price the products, approval has to come, then the meaningful approval, some 5, 6 approvals come then only commercial will start. So this will take time. In 2024, we expect our commercials will start in China.
And sir, on your inhaler business filings, which were there in the U.S., any -- can you give us some more color on how many products have we filed and when we -- from when we're looking at approvals for this segment?
No, we have filed only 1 product as on today, that is a year before -- a year and a half before, and we are working for another 3 projects. And it is maybe if everything is all right in 2023, second half, we can file at least 1 product.
Okay. And sir, secondly, on the oral business in the U.S., there has been during the quarter, a lot of talk about certain companies talking about withdrawing from certain products. Are you seeing any changes in the dynamics in the business as pricing is beginning to improve in certain products? Is there anything improving? Any signs of improvement in the oral business in general?
No. There is no improvement. As we told in the first quarter also, the sizable of 2.5%. The price erosion, 1% of the shelf stock adjustment. It is more or less similar to the -- similar or a little more than the last year. So last year, including shelf stock adjustment, it is 10%, 11%. This year in the first quarter itself, is around 2%, 2.5% and 1% the shelf stock. Shelf stock is only -- only 1 time. It is not a regular thing, 1 quarter time.
But we hope let us see the further quarters because I cannot estimate whether it is going to substantially reduce the price reduction or something.
And then, are you seeing opportunities for shortages and all beginning to improve again? Or the situation is very few shortage of [indiscernible] products? I think there have been reductions, the shortages have reduced quite a bit over the last few quarters. Is there any change on that? Or that's also a similar?
All right, Swami?
No, we have not seen any opportunities because of that, at least I would say we are not seeing any major opportunities as of now.
And sir, last one, we have a very large capital work in progress on our books right now. Can you give us some sense on which are the large blocks of CWIP and when will they get commercialized?
So we have -- Nitin, we have 3 plants in U.S. under installation and commissioning. And apart from that in India also, we have the injectable Vizag plant, then the biosimilar plant, then China plant, right?
Then vaccine plant. India around 3 or 4 plants, U.S. around -- our Dayton plant and Puerto Rico and as well as the Raleigh plant.
All these things are under various stages of things. These things have to come to commercial. And so all these 7 -- almost 7 plants, this is the work in -- this is what you are telling.
And sir, by when do you see commercialization of all these 7 plants coming through?
It starts within a year and end with the next 3, 4 years.
Next question is from Bino Pathiparampil.
So first, a quick question. I believe earlier, you have said that generic Revlimid in the U.S. would be a FY '24 launch for you. Does that hold true even now? And would that be a significant opportunity for you?
Yugandhar.
Yes, it has an FY '24 launch. But as the settlement discussions with the innovator are confidential, I cannot comment on the financial percentages, but yes, we are launching in FY '24.
Okay. Great. And next, a general question. When I look at your U.S. portfolio, a large part -- look at your overall business portfolio, a large part of that is U.S. and Europe. And in both these market terms, slow growing markets, you already have a reasonable market share. The kind of growth we can see is around 5%, 6%, not significantly more than that. And you mentioned that some -- a little while ago as well. So -- and of course, you add all these new things you're trying to do, biosimilars, China, et cetera, maybe it adds a percentage point or so. So is that 6% or 7%, the kind of growth we should look forward to over the next 2, 3, 4 years? Or am I missing something?
That's what we can expect. That's what we are also expecting until unless there is no other -- any surprises don't happen in the global side, the present costs are more or less stable. And we hope next, after a quarter or so the prices slightly may come down also. And that is what we are also expecting because one after the other 6, 7 plants should go into the commercial and profitable. That will take some time. So all these things will come, then definitely, this growth or a little more growth maybe expected after 1 or 2 years.
So my question was more like do you have anything in mind to take this growth from 6%, 7% to, say, 11%, 12%. Is there any such plan in mind?
Bino, like -- I think I can just try and explain the answer. Each and every business unit has a different growth trajectory. Let's assume in a specialty business, whatever you are mentioning that double-digit growth is possible. In terms of OSD, it will be different. In terms of biosimilars, it will be different. So like you need to just look at in the different segments and opportunities and the growth trajectories will be different for different businesses.
Next question is from Tushar Manudhane.
Am I audible?
Yes.
So just on -- just extending previous participant's question. So while these products under -- your different niche categories are under development, and we already have a huge base of existing products under approval or pending approval or already filed. So how do we see the filing pace of ANDAs over, let's say, next 2 years?
[indiscernible]
Just to give some data, Tushar, we have been filing around 10, 12 products. Even this quarter also, we filed 13 products, if I'm right. And if you really see the past, this one in the past also, we have been filing around 50 products plus year-on-year or maybe around COVID time, it has come down. So we don't see a reason why it has to come down dramatically, and they will endeavor to make it continue the same filing.
Sure, sir. And secondly, on the operational costs, like in the recent months, we've been hearing that it is softening. So if you could just put some numbers, let's say, is it down 5%, 10% or even that is too much to us.
5%, 10% on what?
In terms of this inflation-linked [indiscernible] cost or in terms of this logistics cost, we have been hearing that there is some reduction that has happened. So any ballpark number you'd like to put?
Yes. We expect the reduction will start happening, but whether it will have a full impact in this quarter is not sure. But there is -- as Chairman said, the prices are stable. And it started coming down and probably we will be able to see the full impact of it in the next quarter. But certainly, some impact will come in this quarter.
Next question is from Charul Agrawal.
Am I audible?
Yes.
Yes. This is Charul from Bank of America. I wanted to understand that you have $300 million in your cash. Given the current stock position, do you have any plans of stock buyback?
Madam, this is a matter which cannot be talked. It has to be -- there is no proposal as on date on the table. As and when this proposal is talked about it, it will be dealt by the Board and any decision taken, we will immediately inform the stock exchanges. But as on date, there is no proposal as of now.
Okay. Understood. And my second question is regarding the value unlocking in injectable business. So now the strategic investments have seemed to be delayed. Are there any other plans for the value unlocking that we're looking for?
So this matter has been discussed both by the COID and the Board of Directors. And they will look into that any option in the best interest of the shareholders at the appropriate time in the future, ma'am. As on date, we don't see in the next -- I mean, I don't see in the next 6 months, anything will happen like that. But if at all, anything happened, Board will decide in the best interest of the shareholders.
Okay. Understood. And my last question is on the depot-injectable. Do we have any update on the same?
Charul, it is the same thing what I said last quarter. Our 3 depot products are under execution, and we will keep the investors updated every quarter in terms of the progress. But it is on track, as I mentioned last quarter.
Next question is from Damayanti Kerai.
Am I audible?
Yes.
Sir, my first question is on Vizag injectable plant. Did you mention a majority of supply pickup will happen after FY '24?
Yes. Damayanti, it is like this, Vizag injectable plant will start the validations and filings in Q4. Q4, we are -- we'll be doing validations. And then Q1, Q2 is where -- of FY '24 is where we'll be filing. And in all probability, by FY '24, quarter 4, we should start commercializing the plant. And it depends on inspections and other matters, as you said.
So it is -- we'll start with emerging markets in Europe and then subsequently also commercialize the plant for U.S. That's the plan. But this is an additional plant and which we want to use it as both derisking and capacity enhancement for a number of molecules where we have additional demand.
Okay. So for this target of $650 million to $700 million sales for generic injectable, there is less dependence on Vizag plant and you believe the existing capacity should be able to meet the stated goal?
You're absolutely right.
So in existing plants, where all you have expanded capacity?
See, we had existing 4 commercial plants, one Oncology and Hormonal plant, one Penem plant, and so everywhere we have added additional lines wherever we have excess demand. We have added additional lines. And so in 3 plants, we have expanded the capacity. In the fourth plant also, we are planning to expand the capacity. So that is a continuous process, Damayanti.
Okay. And all these expansions are good enough to meet the target which you have set for yourself?
Absolutely. In fact, whatever we feel is, of these 4 plants can take care of demand up to FY '26.
Up to '26, okay. And my second question is on any update on the Unit 7 and Unit 5, which had undergoing FDA inspection in previous months?
I think both the Unit 7, we have already informed the stock exchange that we have been classified as BI. And the Unit 5 also, we have informed the stock exchange at least a month back that it has been cleared. I mean we have given a proper disclosure to the stock exchange.
Okay. And my last question is on vaccines. How should we look at this opportunity moving up in next 2 to 3 years? And what are the key near- to medium-term goals for you here?
Yes. It is -- as we told previous calls, and we told the 1 product we may launch in the -- if the clinical was go through in next 1 or 2 months, we hope the outcome will come. Once it is there, we will launch in India. And then we will -- we are also working in another 2 vaccine projects. This will take another 1, 1.5 years. So that is the way that it's going slow, but it is going very steady.
So mostly 2 years from now, we should be seeing good ramp-up happening here?
In 2 years, we can see profits in this company. That is what I am hoping.
Next question is from Prakash Agarwal.
Thanks for the follow-up. Yes, just 2 things. One is during Q3 call, we had talked about acquisition of 40 ANDAs, 32 I guess, with the market. So is it a function of that, that is playing out in this Q1 where the sales have improved?
No. That is -- work is going on that the CB-30, PAS, and out of that 40 -- and there is -- nothing has come into the -- nothing come to the commercial, and we are hoping and it will come from September, October onwards. One product by other product will come. But because it is -- either it is CB-30 or it is PAS, it won't take much time because the only thing is we have to take the product and take the batches here and keep the stability and file it, CB-30, this will take some time. So that is the reason. Most probably, you can take in the early next year, the commercial -- the result will come from these 40 products. 31 is the overall and 3 are injectables and 6 are derma products.
So correct our understanding. So these are not currently commercialized products, which are having running sales.
No. Not in our portfolio.
Okay. So this gets transferred to your portfolio through your filing? And then you start monetizing the same?
Yes. From early January, we already transferred to Aurobindo name. [indiscernible] name, and we are already working on the filings. We already filed around 7 products. And the commercial benefit will start from early January.
Early January. Perfect. And what is the running, I mean, expected sales run rate from these? How would it start? It would be like a step function? And what would be the expected sales from this portfolio?
I'll come back, Prakash, I'm not really -- how many -- what products I filed, I have to look into that. I will come back on that.
Okay. Perfect. And lastly, on clarification on the first question that I asked. So I think what I understood was this gross margin would be still softer in the upcoming quarter. From 3Q, you would start seeing some improvement with a function of improving freight and raw material cost. Is that correct understanding?
That way, as long as -- if the R&D expenditure is not going up, otherwise, the profit has to start, a little bit improvement should happen.
Okay. Okay. And so when you say R&D, do you -- what is the rate that you're looking at for this year and next year, given that we have a lot of complex products under development, and that would also see filing. So how do you see that ramping up? Or what is the guidance on that?
So there is the program which has been explained, Prakash. First quarter, we had done 5%, and on an average, we have been meeting around 6% to 6.5% last year. So we'll continue to do that probably on an overall basis. Anywhere could be 5.75% to 6.5% could be the thing based on the programs -- how the programs are going fast.
Yes. But would it not be fair to think that this will go up given that you have a significant range of complex products, which will require CB...
From the biosimilars and from the Raleigh plant in the MDI projects, these other plants, more or less every quarter, going very structured way. So there is no -- may not be additional. And so these 2 areas, some additional expenditure, as Subbu told, it may a little bit increase some 1% and 1.5% may increase additional R&D if this clinical expenditure comes into the account.
We need to see, Prakash -- adding to what Chairman said. We need to see the timing whether it can spill over between Q4 and Q1 of next year like that, we need to see that.
Next question is from Kuldeep [ Tyagi ].
So I'm very much confident on pharma business. But could you please elaborate about the vaccine? Like how many products are there in R&D now? And as you said, that 2, 3 products will be rolled out in a couple of years, maybe 2, 3 years, okay? So what is our future prospect on other R&D? These other products?
So we are working on multiple things, Kuldeep, right? We are working on nasal. We are working on derma, as Chairman explained on the inhalers also we are working, transdermal, we are working, et cetera. If you really see -- in the case of nasal, we have already got 2 products approved, and we have filed 1 product and development is around 9 products. And derma, we are working more than 30 products, and we have already filed some products.
Sir, you are talking about derma, but I have talked about vaccines. So is...
You're talking about vaccines?
Yes, I'm talking about vaccines.
As on vaccine, as the Chairman explained, we have already done the PCV vaccine, which is the outcome of the results will be known in a couple of 2, 3 months may we'll come to know of it and that is what we are working as on date.
And another 2 projects we are working that is with the [indiscernible].
And you said that it will be launched in India. So is there any other competitors are also there for these products?
Yes. There must be another 1 or 2 people definitely, including [indiscernible] and those things. And we are going to take up after that to WHO. That will take another 1 year.
Okay. Okay. And what could be the market size if it is launched maybe in 2 years?
We have -- let me check with the concerned person at that, but -- we'll come back to you in the next one.
Next question is from Vishal Manchanda.
Would you have a number as to what would be Aurobindo's market share in the oral solid dosage category in the U.S.? By prescription volumes.
Yes. So by prescription volumes -- Vishal, by prescription volume, we are #1 in the U.S., and that is just by Aurobindo itself. We also have some private labels that would be additional. So we had done in the last 1 year through May, based on the IMS, we have done about 4.4 billion tablets approximately. And so this is -- with this, we are the #1. On an annual basis, we are close to around 20 billion.
Okay. And 20 billion is in terms of number of tablets, you said?
That's correct. And this is only from Aurobindo side, plus, as you know, we also have some partners.
[indiscernible] what is the percentage he is asking, Swami? [ Overseas ] around 7%, 7.1% or how much is, Swami?
If I'm correct, it is 8.3%, Swami?
Somewhere around that. And we'll come back.
That's in the oral solid dosage category? 8.3%.
Yes, that's what in.
We'll come back to you, Vishal.
Okay. And sir, the second question is on Folotyn. So there's a settlement in November 2022. So if assuming generics enter post that, would we -- would that materially impact our EBITDA or it will be -- it will not be a material event for us?
Some extent, it will impact us from end of this year.
So do we have launches that could set this off? Or this would obviously be large for the company?
No, the derma -- 2 derma products, the clinicals already in the middle way. And there is a gap will come -- this gap will come in 2023. From 2024 onwards, calendar year approximately, this will cover up, and that is what we are expecting.
Okay. And just one fundamental question. So on oral solids, I think even Aurobindo would be doing mid to high single-digit ROCE. And probably we -- I think Aurobindo would be the lowest cost player in this space. So how long do you think the situation can persist? So based on your assessment of capacities that would be available in this.
No. We are not the lowest cost of production, whatever the India people are producing same cost probably we are also. Because we have a good number of ANDAs. So we are producing a little more. But this will -- we hope this will continue and some more additional products are expected to join in this. Out of that, at least, some will get clicked. And this will continue for, we hope, next 7 to 10 years, maybe or more.
What I mean is the ROCEs would be in low single digits. So can this -- will this go -- can this go further down? Or how do you think the industry will shape up because this is an unsustainable number.
This further going down is a very difficult, but still we cannot get. We don't know exactly what is going to happen.
But if you ask me, it should not go as per [indiscernible]. So it has already gone down like anything.
That was the last question. I would now like to hand the conference over to Ms. Deepti Thakur for the closing comments.
Thank you all for joining us on the call today. If you have any of your questions unanswered, please keep in touch with the Investor Relations team. The transcript of this call will be available on our website www.aurobindo.com in due course. Thank you, and have a great day.
Thank you. On behalf of Aurobindo Pharma Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.