Welcome to Aurobindo Pharma Q1 FY25 Earnings Call. Please note that all participants' lines will be in listen-only mode, and there will be an opportunity for you to ask questions after the opening remarks. Please note that this conference is being recorded. I now hand the conference over to my management for opening remarks. Thank you, and over to you, sir.
Thank you, Andit. Good morning and a warm welcome to our first quarter FY25 earnings call. I'm Shriniwas Dange from the Investor Relations team. We hope you have received the Q1 FY25 financials and the press release that was sent out on Saturday. These are also available on our website. I would now like to introduce my senior management team on the call with us today, represented by Dr. Satakarni Makkapati, CEO of Aurobindo Biosimilars, Vaccines, and Peptide Businesses, and Director, Aurobindo Pharma Limited, Mr. Yugandher Puvvala, CEO of Eugia Pharma Specialties Limited, Mr. Swami Iyer, CEO, Aurobindo Pharma USA, Mr. V. Muralidharan, CEO, Europe Formulations Business, and Mr. S. Subramanian, CFO. We will begin the call with the 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 other important factors may cause actual developments and results to vary materially from our expectations. Aurobindo Pharma undertakes no obligation to publicly revise any forward-looking statements to reflect future events or circumstances. With that, I will hand over the call to Mr. S. Subramanian for the highlights. Over to you, sir.
Thank you, Shriniwas. Good morning all, and welcome to our Q1 FY25 earnings call. Before we get into the details of our Q1 performance, I would like to state that we have published our second integrated annual report for FY24, which includes details of our progress so far in terms of our business and financial performance, and also touches upon our strategic pillars and growth levers. I am also glad to share that we will be completing the first-ever buyback of INR 750 crore in August 2024 at a price of INR 1,460.
The cash outflow for the company is expected to be around INR 935 crore against the FY dividend of approximately INR 264 crore and will provide a tax-efficient return to our shareholders. Now, coming to our Q1 FY25 performance, I am delighted to state that with our quarterly performance reflecting our top year-on-year growth of 10%, amounting to INR 7,567 crore.
This growth is seen across the market, driven by new product launches, market share gains, expansion into new geographies, and stable price. Our Q4 FY24 base has been higher due to the accounting of Q2 and Q3 FY24 income of approximately $20 million from Indonesian operations. Excluding the above additional revenue, the quarter-on-quarter growth was higher by 2%. US recorded revenues of $426 million during the current quarter were marginally impacted by seasonality. The Europe market demonstrated a strong performance and has achieved a revenue of EUR 221 million and is on track to achieve EUR 880 million plus for FY25. Further, overall growth market performance has been good during the quarter. Our EBITDA margin remained at 21.4% and is aligned with our expectations. EBITDA margins are supported by stable raw material prices and operating leverage due to incremental plant utilization.
This was partially offset by higher OpEx from newly commercialized plants, including Pen G, higher L&P expenses on account of few non-recurring expenses, including remediation and associated production delays that effectively reduced the EBITDA and PBT by more than INR 100 crores. This is likely to compound significantly further in the future quarter. This, coupled with the Pen G ramp-up, is expected to further support the EBITDA margins in the upcoming quarter. At a full-year level, we are confident of achieving our overall internal EBITDA margin target of around 21%-22%, as mentioned during the last earnings call. Our net profit for the quarter increased by 61% year-on-year to INR 919 crores. Now, let me take you through the business-wise highlights for the quarter.
In terms of the business breakdown, the formulation business, excluding Puerto Rico in Q1 FY25, witnessed a growth of 15% year-on-year to INR 6,475 crores and contributed around 86% of the total revenue. The revenues are mainly supported by growth across markets of the U.S., Europe, and growth markets. For the quarter, the API business contributed around 14%, and revenue increased by 6% year-on-year to INR 1,019 crores. The growth in the API business is mainly driven by higher volumes on account of improved asset utilization. During the quarter, U.S. formulation grew by 12% year-on-year and recorded a revenue of $426 million. The growth was mainly driven by volume gains, stable demand, and new product launches, while on an overall basis, price erosion remained neutral due to the off-season QoQ revenues dropping slightly. During the quarter, we filed eight ANDAs, received final support for 10 ANDAs, and launched 10 products.
A few of our key approvals in the recent quarters, including mometasone, isotretinoin, and estradiol inserts, etc., will be reflected in the coming quarters. Revenue from the oral generics in the U.S. increased by 12% year-on-year to $277 million, driven by new launches. Revenue from the injectable and specialty business in the U.S. increased by 12% year-on-year to $102 million. The total injectable specialty sales globally increased by 16% year-on-year and secured $142 million. We have a total of 224 specialty and injectable ANDA filings as of 30th June, out of which 170 are final approval, and the remaining 54 are awaiting final approval. The company has, as on 30th June, 838 ANDAs filed with the U.S. FDA on a cumulative basis, out of which 668 are final approval and 26 are tentative approval. 144 ANDAs are under review.
For the quarter, European formulations clocked a revenue of INR 1,982 crores and an increase of 8% year-on-year. In constant currency terms, European revenue was EUR 221 million against EUR 205 million of last year Q1. For the quarter, growth market revenue increased by 49% year-on-year to INR 709 crores. In US dollar terms, the revenue grew to $85 million in Q1 FY25. The increase was mainly driven by sales across markets and new geographies. For the quarter, ARB formulations business revenue increased by 14% year-on-year to INR 229 crores or $27 million. This was supported by pickup in volume, partially offset by price erosion to some extent. Now, going to other highlights, the raw material costs continue to be at the midline levels and are in line with the previous quarter, supporting our gross margins, which stood at 59.4% against 53.9% of the previous year. In absolute terms, gross contribution was INR 4,494 crores.
R&D expenditure for the quarter stood at INR 339 crores, which is 4.5% of the revenue. Net Capex for the quarter was around $74 million. The average USD/INR exchange rate is 83.41 against 83.04 in Q4. The average finance cost is around 6.5. The business has a net cash inflow of $89 during the quarter. As a result of the net cash position, including investments at the end of June 2024, it improved significantly to $101 million. The gross debt stood at $833 million.
We expect to continue our growth trajectory back by volume gains, new product launches, and stable pricing. We are on track with respect to Pen-G's large-scale commercialization and are hopeful to ramp up significantly from October 2024. With expected volume pickup in the U.S. markets and ramping up of newly commercialized plants, benefits are expected to accrue to the top and bottom line in the coming quarter.
We expect the current pricing scenario in the US market to continue. European growth markets are expected to continue the growth momentum. We are confident of achieving our internal EBITDA target margin of 21%-22% for the year FY25. Our China plant is expected to be commercialized from Q3 FY25, and the ramp-up is expected from Q4 FY25. With our focused and strategic investments in R&D, we continue to develop strong product pipelines. Our biosimilar complex products are progressing. The clinical trials are advancing. Dr. Satakarni, the CEO, will elaborate on this. This is all from me now. Our business leaders will give more clarity on any specific aspects in our Q&A session. We are happy to take your questions. Thank you.
Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may raise your hand from the participant tab on the screen. Participants are requested to use headphones or earphones while asking questions. Participants are requested to refrain themselves with two questions. The first question is from Kunal Randeria.
Hi, good morning. Thank you for the opportunity and congratulations on the good side of numbers. One for Subbu sir on the EBITDA margin guidance of 21%-22%. Since adjusted for some of the one-offs that you highlighted, this quarter we would be at roughly 22.7%. And we expect, we also said that this is kind of, you know, seasonally, slightly muted quarter from the US perspective. Also, we have baked in all the Pen G-related commercialization expense. So shouldn't the run rate from year-on-year improve? And, you know, is there any possibility of raising the EBITDA margin guidance at this point?
Kunal, you're absolutely right. But if you recollect in the last earnings call, I said very clearly we will revisit the EBITDA guidance in the earnings call of November, that is the second quarter call. We will be looking into that and then reply accordingly.
Yes, sir. And in terms of Pen-G plant cost, we have baked in for the full three months in this quarter?
Yeah, I think that the three months we didn't have much sales at all because of the various reasons in the Pen G plant, because the equipments are ready for the mechanical integration, and we have synchronized the power and boiler. We lined up all the utilities together, and we are encountering teething problems in the last. We encountered teething problems in the last quarter when we were trying to scale it up, mainly due to the different operating environment compared to some of the foreign countries. So we are expected to do around approximately 20 batches this month, followed by another 30 batches in the next month. If these two go well, I think we will, more or less, be able to ramp up in a significant manner in the Q1.
Sure, sir. But my question was more on the operating expenses side. Is it already baked into our P&L?
Yes, it has been already. No, it has everything got into the P&L.
Sure. And depreciation of INR 400 crore plus also reflects?
It reflects all the plant depreciation, everything.
Sure, sir. Thank you. And one for Satakarni sir, if you can provide any incremental updates on our biologic/biosimilar business over quarter four, it would help.
Good morning, Kunal. So with our biosimilars initiative, we are making the intended and steady progress with our clinical trials as well as our review of our filings. Our pipeline now extends up to 2032, and I'm reasonably convinced about the progress we are making. With the first wave of biosimilars, I'm pleased to state that we have achieved an important milestone in May of completing recruitment of all patients as part of our denosumab trial in European sites. The clinical study closure will be in June next year, and we will be on track to filing this product with both the European Medicines Agency and the FDA in the second quarter of the next year. Now, as you guys know, denosumab is my first foray into the immunology segment.
Likewise, an important product of ours is the biosimilar to omalizumab, which I have been continuously updating in these earnings calls. The product fits well into our dermatology portfolio with its use in chronic spontaneous urticaria. Also, with the treatment for accidental food allergies now approved for this product in the U.S., we are confident of the broader scope of treatment that omalizumab can offer across respiratory asthma, accidental food allergies, and chronic spontaneous urticaria. We have completed a successful phase 1 study in Australia in healthy volunteers for this product. This I have updated about. The product is now being studied in a large phase 3 clinical trial comprising of more than 600 chronic urticaria subjects in Europe. Separately, a small study also is being conducted in respiratory asthma patients in India.
So the Indian clinical study, to give you guidance, will be completed by the end of this year, allowing the product to be filed in India and certain emerging markets by Q3, Q4. A large European study will be completed by the mid next year, and we hope to file the product in Q3 next fiscal with EMA and the FDA. So with both these immunology assets, which is a departure from the oncology assets that we are already in, we are hoping to file both these products with EMA and FDA next year. Then, as you know, there are two more products of ours in phase three clinical studies, and their progress is okay. The pace of recruitment could have been better with our ophthalmic product, but that's the nature of the ophthalmic trials. It's going pretty slow.
But I'm confident of completing the trial for the ophthalmic product in 2026. But the oncology product, we have completed about 80% of the recruitment, and I hope to complete the recruitment in Europe by the end of this year for this product and also probably complete this profiling in next year. Now, with respect to our current product filings that are with EMA, they are going through the review process. I expect us to be able to meet the requirements within the clock-stop period that we are in right now. And hopefully, in two quarters' time, we'll be able to see these approvals starting to trickle in for these three products one after the other, provided there are more regulatory uncertainties. Our trastuzumab US filing that I told in the last quarter in the earnings call that we'll be filing this quarter slightly got delayed by a month.
We are still on track to filing it, and I hope to file it in the next 4 weeks to 8 weeks with FDA. I have completed a type 4 meeting with the FDA, so the decks are now fully cleared from the U.S. FDA based on the type 4 meeting to file trastuzumab with the U.S. FDA. So in all, I think we are progressing well. Our tocilizumab biosimilar, which is another immunology asset, which is catering only to India and emerging markets, they have completed a phase 3 clinical trial in India, and I hope to file this product in the next 3 to 4 months' time. But this is India and emerging market product only. So in a nutshell, we are reasonably convinced about how our biosimilars business is shaping up, and I think our products will start to reach the intended markets from next year onwards.
Yes, sir, thank you. Abhinu, if you can quickly also update on the biologics business, Abhinu, where are we in the process of putting the 30,000 liters capacity, etc.?
As you know, in the last earnings call, I have talked about us being optimistic about closing the deal with MSD Singapore and India. After three days of the earnings call, we have signed on the dotted line. Now we have entered into a definitive agreement with MSD, and we have one product schedule as well with them. The definitive agreement means that the civil works of the facility have now gathered pace, and I hope to complete the project by 2026, which allows the engineering batches to be the water runs to be conducted. From 2027 onwards, I expect the US filing process to begin for this product and the revenues to trickle in. The facility is progressing well, and I'm reasonably confident of executing the project on time in 2026 for the engineering batches to be taken within the facility.
So I don't see any showstoppers there. The thing is progressing well. Kunal, I believe that answers your question.
Bye, sir, good luck, and I'll have more questions as you advance. Thank you.
Thank you.
Thank you. Requesting everyone to refrain themselves with two questions, please. The next question is from Amey Chalke.
Yeah, hello. Am I audible?
Yes, you are.
Okay. Thank you so much for giving me the opportunity to ask a question, and congrats to the management and good set of numbers. First question I have, is it possible for management to guide how the revenue sales have moved from quarter four to quarter one?
We are not specifically talking about revenue as a separate sales segment, but our run rate continues to be in a similar way when we launch the product, and we expect to continue in a similar way.
Sure. I don't want a quantification, but qualitatively, is it possible to guide or?
Qualitatively, at this point of time, yes, the pricing remains constant. We don't see any decline, and we are trying to, as best as possible, to schedule it in such a way that every quarter we have a decent set of numbers. Except for one or two quarters, we expect the similar run rate to continue.
Sure. Should we assume that this year we should book higher sales compared to last year, or it should be similar?
It could be like 10%, 15% here and there, but it will be similar.
Good. Good. Second question I have is on the Europe and China revenue potential considering both China plant and Visakhapatnam plant are being operational in FY25. So if you can give us some outlook on both these jobs. Thank you so much.
You want to try now, Arun?
Hello?
Visakhapatnam. I think he's talking about Eugia Visakhapatnam.
Yeah. Let me just talk about Eugia Visakhapatnam, then probably Subbu can take care of China. Eugia Visakhapatnam plant, it is up and running. We started capitalizing the plant last quarter itself, and our European audit is done, and we will be hopefully starting filings from next quarter because we are waiting for the GMP certificate to come from European authorities. Once we receive the GMP certificate, we will start filing products for Europe. And our US filings are also on track, and hopefully, like we should do, around 3 filings -4 filings this year. So I expect the revenues to start from FY26 onwards.
Yeah. So in terms of the China, we are planning to start a small volume in the month of November, and expect to ramp it up in the period between January to March quarter of last next year. And the full-fledged volumes will start going only in the next fiscal year. So in fact, because of this, also we are trying to do some filings for China as well as for U.S. also. We are trying to do that. So all this will take the China revenue potential up in the coming years. This year, we'll see only a small little volume and value.
So if I may add, Subbu, something to what you said. In China, we have also shipped the first commercial product for BFS through our JV partner. So as you know, we have a JV there. So that is something I just wanted to add.
Yeah.
Thank you. The next question is from Neha Manpuria.
Yeah, thanks for taking my question. My first question is on the U.S. business. I thought we were supposed to see improvement in the U.S. business with the resumption of the facility in the quarter. Could you give us some color on what's happening to that? Should we expect the improvement in the injectable business to be a little more slower versus our initial expectation? And just an extension to that question, we've seen another facility get an OAI for the injectable business. How are you thinking about compliance for the injectable business, given that's key for our growth momentum in that in UGA?
Yeah. Thanks, Neha. Yes, you're right. In fact, we thought last year, Q4, we have taken the hit, but because we wanted to be robust enough in terms of our remediation action, so it continued in Q1 as well. So our overall manufacturing was not to the fullest extent what it used to be. So Q4 and Q1, two quarters, I have taken the hit in terms of other remediation actions for the Eugia Unit III plant. So I'm cautiously optimistic that from this quarter onwards, that is Q2 of FY25 onwards, our regular injectable business should move up. I'm quite confident of that. Coming to the second plant, which is our Bhiwadi plant near Delhi, which got an OAI, we are working with FDA, and I'm confident that that can be resolved. That's a lesser evil than the Eugia Unit III.
We feel like whatever perceived issues the FDA has in the next 1 months -2 months, we should be in a position to clear that. So as I said, I'm cautiously optimistic at this point of time of resolving the FDA-related issues at the same time the sales momentum going up from Q2 onwards.
Does that make us confident to be able to gain the lost market share for these injectable products? Because I can see that we have lost market share in some of the products in the injectable side.
I think at this point of time, the way I see it is I don't think we have lost too much of market share on any of the molecules. It is mainly the supply constraints what we created on ourselves, and that is what has taken a bit of a beating in terms of Q4 and Q1. But once we start ramping up, which is what we are already on the way, I'm sure we will gain the sales. We haven't lost too much of market share in any of the molecules.
Got it. And my second question is on Europe, particularly strong quarter. I know Subbu mentioned in his opening remarks that this will be north of EUR 80 million for the full year. Could you give us some color, the reason for the step up in the quarter and why we believe this will be sustainable going forward?
Yeah. Good morning, Neha, and good morning, everyone. Yes, I'm here to take this question. Yes, Europe has been a contributor, silent contributor to the global revenue of Aurobindo in the region of 25%. We are having certain plans for new launches. If you take the Q1 performance and on a straight line, this alone will be touching EUR 880 million, but also we have a couple of major launches coming up during the year. We are quite confident and believe that we'll be able to go north towards EUR 850 million, towards EUR 880 million - EUR 900 million. Thank you.
Understood. Thank you so much.
Thank you. The next question is from Damayanti Kerai.
Hi, good morning, and thank you for the opportunity. My first question is on remediation-related costs. So in your opening remark, you mentioned there were some additional costs which you incurred in first quarter due to this remediation charge, etc. So can you quantify that, and how much of that could be seen in this current quarter, second quarter also?
Damayanti, we have in Q1, we have spent around $9 million against the remediation cost of Eugia Unit 3, and we expect Q2 to be only a very fraction of that $9 million. I think hopefully it'll be around $2 million, and we have completed all the remediation, and we don't expect anything more than what we have already spent. So Q1, yes, it says $9 million plus, and Q2 would be around $2 million +. That's what is our expectation.
Okay, so majority done, and now maybe a few related to Bhiwadi plant, which you might not know.
Bhiwadi, we don't need any remediation there. It is only clarification. So it is going to be more about clarifications. Obviously, absolutely there's no remediation in Bhiwadi. It is only Eugia three where the remediation was required, and we have, to our best of our effort, we have done that particular piece, and that's over.
Okay, and you just mentioned Q2 onwards, you expect the generic injectable sales to move up, and then maybe you'll back to the pre-disruption stages.
That's right.
You maintain your guidance for global specialty, like Eugia sales, which you had given some time back?
Yeah. In fact, for this year, I've already guided that we will do around $600 million plus. I think we still are optimistic about touching the $600 million.
Okay, and my second question is on your Indonesia operation. So you mentioned $20 million sort of sales you have booked. So what kind of ramp-up you see in that market? Are you optimistic about ramping up this significantly?
No, Damayanti, what I was mentioning is in the Q4, we have accounted the Q1 and Q2 sales because Q3 sales, because we did the closing sometime by December 20th or something. So the entire thing, the net economic benefit has flown into the quarter four. That is the reason why it has come there. Otherwise, we have been traditionally doing around $8 million per quarter, and we will continue to do that at least for the year. We are also thinking how to increase the overall sales and ramp it up because this is the existing business. So now the challenge is how to increase it, how to ramp it up to the next level, which we are working on.
Okay, so that's clear. Thank you.
Thank you. The next question is from Shyam Srinivasan.
Yeah, good morning. Thank you for taking my question. Just the first one, again on the European business, you talked about the $850 million for the full year kind of run rate. So just want to understand how is the underlying profitability of this business now tracking? Have we moved past that double digit into mid-teens in terms of the margin profile?
I think, Shyam, in terms of the Europe business, I think they have been doing it extremely well in the last 2-3 quarters. They have been gradually increasing their overall revenue, overall margins, and I think the margins have already moved to nearly mid-teens level. And with the way Murali has communicated, and this is expected to be sustained, if not improved.
Well said, Subbu. I agree with you. Yeah.
Muralidharan said, just in terms of the integration where we have tried to move to some of our local plants, how far are we on the journey and how much more can be done incrementally for us integration for the European business?
When you talk of local plant, in Europe, we have only the plant at Generis, Portugal. But if you're referring to the expanded facilities in India, the unit has undergone expansion, which is clearly helping us in feeding the markets. Despite Q1 being months, which is still impacted by Red Sea issues, the production and dispatches from India has really helped us in time to market being achieved. We are doing fine. When China plant starts feeding us, all the more we will be able to supply clearly to the market better.
That's helpful. Just quickly on the second question, if I were to look at the Pen-G plant, has all the CapEx now done, Subbu Sir, in terms of what CapEx we had to do? And in terms of the ramp-up for this particular business, you talked about costs being there. When are the likelihood of the revenue starting to kick in for this plant? Relating to the CapEx, Shriniwas, we have more or less incurred around 95% of the CapEx. Any 5% is depending upon what is the requirement while we are ramping up, what are all the new requirements coming, that is what we will do. So more or less the CapEx is good. The second question is, as we didn't have any revenue flown, any significant revenue flown last quarter.
This quarter, we are planning to do a good set of batches as a process of ramping up, which is expected to give some revenue during this quarter. But next quarter onwards, these two months are very critical, August, September. Once we achieve that, next quarter, we'll be going towards 80% of the ramp-up. We are working towards that. So we will be able to tell better in a better we'll be able to give better clarity during the second quarter running score. Understood. Thank you and all the best.
But I just want to add, Shyam.
Yeah, sure.
We have taken some good number of operating expenses because we didn't have the sales during the quarter. Once the ramp-up, etc., comes, and not only it helps in overall growth of the company, increasing the EBITDA margin, the existing operating expenses cost, which we have incurred during the period of stabilization, will not be there.
Understood. Thank you. Thank you.
Thank you. The next question is from Bino.
Hi. Good morning. Good evening. A couple of questions on U.S. products. There was this product, Generic Emflaza, which you had.
We can't hear you.
Hi, Bino.
I know your voice is a little less. Can you please?
Hello?
Is this better?
No.
Still the same. It's very low.
Hello?
Can you hear me now?
It's a little better. Subbu Sir, can we?
Yeah. Go ahead and ask the question.
Okay.
First question regarding this product, Generic Emflaza, which we had launched in the US a few months back. How is it doing? Are we only the player in the market still? That is Deflazacort.
Deflazacort .
Yeah.
Sorry?
Yeah. I'm coming to that. Yeah. Deflazacort, yes, we launched this product. At this point, I think we are the only player.
Okay. And do you?
That is for the tablets.
Okay. And do you expect that situation to continue for some time?
We can't predict that, but we have strengthened this product, so we think that we continue to do well.
Okay. Second, there's Lifitegrast ophthalmic solution for which you have an approval already. Is that a product we can expect in the next 12 to 18 months, or is it far away?
No, I couldn't hear what you're saying.
It's actually like it's quite far away because we have already.
Lifitegrast .
Yeah, Bino, this is Lifitegrast. It is not going to be anytime soon. We have the final approval, but we also have a settlement with the innovator. Based on that, I can tell you that it is not a 12-18 months period product.
Understood. And finally, on Mirabegron, where there is some litigation going on, some people have launched. Do you have plans to launch near term?
No, Bino, you have raised this question at least twice in the past, and we responded to you. We have a settlement in place. So whatever the two companies which have launched have launched, I understand at risk. There's a case that's ongoing, and the hearing is expected. The final hearing is expected sometime in October or end of this year. We'll have to watch. But all that I want to tell you is that we have a settlement based on the settlement. We cannot launch now.
Got it. One final question on MSD, if I can push it. The deal, would it be for manufacturing of products also for the U.S. and European markets, or would it be more for the emerging markets?
Bino, right now, the markets are still under discussion, but it will be a majority of the markets with probably Europe also coming in. But owing to the confidentiality nature of the discussions that are unfolding between my team and the MSD, I would not be able to provide any more update on this now. But as and when things get more clearer, I can provide you an update.
Understood. Thank you very much.
Thank you.
Thank you. The next question is from Jigar Valia.
Yeah. Thanks for the opportunity. My first question is now with this unitary classification also kind of getting out of the way, things getting resolved. Are the board probably planning to go back to the proposed spinoff or IPO listing for UGA?
So, Mr. Jigar, last year, I think if I'm right, in the month of August, the board has decided to evaluate, explore various options. And we put it on hold subsequently because the inspection for the Eugia business has started. All the units have got the inspection. So now that inspections are over, we can revisit it. And some of the bankers are also approaching us. So we have to decide. But as a non-executive decision taken, and we are going to implement, we will certainly inform the market as per the compliance.
Okay. So one question is on the margin. You mentioned about 100 + 1 of this quarter, which gradually will reduce with the operating scale and the business ramp-up. But is it right that as the business scales up, it will take a while? I mean, it will take its time to come to the company-level margin. So overall, we maintain at 21, 22, while in absolute terms, definitely ramp-up.
Mr. Jigar, my colleague Mr. Yugandhar has clearly articulated that we had a ramping-up remediation cost of around $9 million plus, which is expected to come down to $2 million this quarter. That itself clearly shows that we are going to cut it down during the quarter.
Absolutely. So the absolute EBITDA will be more reflective and as the size of the.
More reflective. Yes, more reflective. But with this OpEx, it will not be there.
Understood. So last question is with this board change and now the new chairman, etc., is there anything different on the board meetings or other things?
No. We have been conducting the board meetings with the highest standards always. And with the new board chairman comes, he's bringing his own set of ideas and things which we are implementing. And we are also strengthening the board by having one more executive, I mean, one more non-independent director named Dr. Deepali Pant Joshi. And also Dr. Satakarni Makkapati also joined the board to strengthen on the R&D side and the science side. So board is now really a lot of new things are happening in the board meetings.
Thank you. Thank you so much, sir.
Thank you. The next question is from Ankush Mahajan.
So, good morning, sir. So my question is related to the injectable. If Pfizer is taking run rate of the G revenue and the other business in the injectables has shown either it's flat or showing some declining. The reason that you have explained also, I just try to understand what is, how is the price erosion in the respiratory season? How is the price erosion in the injectables if I deduct the G revenue part?
The price erosion is low single digits.
Okay, sir. Thank you, sir.
Thank you. The next question. The next question is from Kunal Dhamesha.
Thank you for the opportunity again, sir. Subbu Sir, on the effective tax rate this quarter, we have hit around 30%. If you can provide the outlook for FY25 and what is driving this higher ETR for us?
So see, some of the units, like biosimilars company and the Lyfius, which is a Penicillin tech company, where we are incurring the OpEx, we are not taking the deferred tax credit. Right? Once we start a tax credit, obviously it will fall down. And in terms of the year as a whole, with a Lyfius' plan, expected to do well by fourth quarter, etc., probably we may come to a more than a break-even scenario by which the tax rate and the tax credits will be taken. The tax rate will come down. Overall, I think we will be somewhere around 27%-28% is what my feeling at this particular point of time.
Sure, sir. Thank you for that. And one for Yugandhar, sir, on Revlimid, we said that the net revenue contribution this year would be 10%-15% higher than last year. But this time around, we'll also have a full year impact of Revlimid, right, versus the half-year impact for last year. So shouldn't the contribution be higher?
Yeah, Kunal, frankly, I never wanted to say anything about Revlimid because we never said we never announced what is the Revlimid sales, whether it is last year or this year. I only just generally guided it. And it is also, as you know, Kunal, it is about settlement periods. Some can have an overlapping effect on some other periods. So I think it is better to leave it there.
Sure, sir. Thank you.
Thank you. The next question is from Rahul Jeewani. Hi, Rahul. We request you to unmute and ask your question.
Mandit, let's go to the next question, please.
Yes.
The next question is from Tarang Agrawal.
Hi. Good morning. Am I audible?
Yeah.
Okay. A couple of questions on Eugia and then on the U.S. business. You know, over the last two years, how has your market share moved in the U.S. injectables business? Because there's been quite a lot of movement in the marketplace specifically. So just wanted to get a pulse on how the market share has moved, one. And second, what's the dollar impact of revenue, say, in Q1 because of the remediation activity happening in UGA3?
Yeah. In injectable business, mainly the specialty portion of the U.S., it is steady. I will not say like we had too much of growth because of, in fact, last year, I was expecting that we will move very well, but UGA3 hit us in Q4 because of that Q4 and the impact continued in Q1. So in general, I can say it is stable. Obviously, we could not grow too much because of UGA3 impact. And what's your second question, Tarang?
Dollar impact or revenue because of Eugia 3?
Revenue impact, I told you like last quarter, that is Q4 of FY24, we had a $20 million revenue impact. And Q1, we had around similar $50 to $20 million impact. Okay. And we hope that's the end of it.
Perfect. That's quite helpful. So now in the US, Swami sir, is it possible for the OSG business to reach $300 million quarterly run rate anytime soon purely from products perspective in terms of market approvals and from a capacity perspective on the back end?
Yeah, Tarang. I will not give a specific number, but I can generally talk about it. The U.S. business, as you have seen, has been doing well. We have made major strides in building on our past success. Our business is right now demonstrating good, very strong momentum. We found that our volume-based strategy with global capacity and the talent pool that we have has helped us to grow into this kind of large generic company. These are the basic factors, and that factor remains, and it really gets strengthened. We also have a number of new launches. Last year, we guided that we are going to have a few launches that will be coming in. This year also, we expect a good amount of launches, somewhat similar to last year. We are getting products from the JV in China.
We are also expecting commercialization sometime in the near future for the US oral solid. So overall, I feel fairly optimistic, and we believe that the US oral solid will do well. As far as the number is concerned, we had a good amount of growth in the recent past. And if this continues, we should be close to that number or achieve that number sometime soon.
Sure. And specifically on the OTC business for this quarter, I saw some softness. Is it just a quarterly aberration, or is something happening there?
Yeah. So OTC business was soft this Q1. There are a couple of reasons. One is that seasonality. Definitely, this was not the season. And despite that, it should have been better, that I agree. But we are optimistic. We have some new awards that are going to start sometime this quarter. And I think that will get rounded up sometime during the year. We believe that we will see some progress in the OTC business going forward, at least from Q2. That is our expectation. And we also have the OTC branded business that's given us a separate company. We have recently had restructuring in the last one year of the leadership team, and we have got a new strategy. We are very optimistic about the future of that business too. Overall, we think we will see better times for OTC going forward.
Okay. Just last two. Any update on Ryzneuta? I mean, how is that product shaping up?
Yeah. Ryzneuta, unfortunately, there were some problems with the CMO. We were due to launch in the Q2 of this year. The problems are being resolved, and I think there could be a delay, and the launch would be probably in the last quarter of the current fiscal at this point of time.
Okay. And the last question on Europe. Given that the business has achieved almost EUR 900 million, EUR 850 million-EUR 900 million run rate, and the margins have moved to mid-teen levels, are there possibly more levers in the business from the point of view of margin expansion? Or just wanted to hear your thoughts there. Or we should expect it to remain at these levels now from your end?
No, Tarang, thank you for this. Yeah, obviously, we expect to move upwards. Of course, on the oral solid business, which is predominantly the contributor as of date for the European revenues, we are trying to do our very best. But we are also, as very clearly explained by Dr. Satakarni in his initial elaboration, we are keenly looking at the launch of some of these biosimilars in the upcoming period. And that would contribute to increasing the better margin substantially. Similarly, also, we are looking at the Vizag plant of Eugia to start feeding us, which will be enabling us to participate better in the tenders, in the process, put up our revenues and margins. So the brighter period is ahead of us. We are keenly looking at it. Thank you.
Thank you, sir. All the best.
Thank you.
Yeah.
As this was our last question, I now hand the conch over to my management for closing comments.
Thank you all for joining us on the call today. If you have any of your questions unanswered, please feel free to keep in touch with the investor relations team. The transcript of this call will be uploaded on our website, www.aurobindo.com, in due course. Thank you and have a great day.