Aurobindo Pharma Limited (AUROPHARMA) Earnings Call Transcript & Summary
November 6, 2025
Earnings Call Speaker Segments
Operator
operatorLadies and gentlemen, good day, and welcome to Aurobindo Pharma's Earnings Conference Call for the Second Quarter of FY '26. [Operator Instructions] Please note, this conference is being recorded. I now hand over to Mr. Varun Mali for the opening remarks. Thank you, and over to you, sir.
Varun Mali
executiveThank you, and good morning, ladies and gentlemen, and welcome to our second quarter FY '26 earnings call. I'm Varun Mali from the Investor Relations and Corporate Communications team. We hope you have received the Q2 FY '26 financials and the press release that was sent out yesterday. These are also available on our website. I would now like to introduce our senior management team on the call with us today, represented by Dr. Satakarni Makkapati, CEO Aurobindo Biosimilars, Vaccines and Peptide Businesses and Director, Aurobindo Pharma Limited; Mr. Yugandhar Puvvala, CEO, Eugia Pharma Specialties Limited; Mr. Swami Iyer, CEO, Aurobindo Pharma USA; Mr. V. Muralidharan, CEO, Europe Formulation Business; Mr. S. Subramanian, CFO, Aurobindo Pharma Limited. 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 information 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 active developments and results to vary materially from our expectations. Obando Pharma undertakes no obligation to publicly revise any forward-looking statements to reflect in future events or circumstances. With that, I will now hand over the call to our CFO for the business highlights. Over to you, sir.
Santhanam Subramanian
executiveGood morning, everyone. A very warm welcome to Aurobindo Pharma Q2 FY '26 Earnings Call. Thank you for taking the time to join us today to discuss the company's financial and operational performance of the second quarter of the current fiscal year. Let me begin with a brief summary of our performance. Our consolidated revenue grew by 6% year-on-year to INR 8,286 crores, a reflecting sustained best momentum through the first half of FY '26. The growth was driven by strong U.S. formulation-based business and continued momentum in our European and growth market operations. EBITDA for the quarter stood at INR 1,678 crores, with a margin of 20.3%, demonstrating a 7% year-on-year growth. The performance underscores our operating leverage, cost efficiency and disciplined execution, business highlight. Let me now walk through the key business highlights for the quarter. The overall formulation business reported a year-on-year growth of 10%, with revenues reaching INR 1,325 crores. contributing approximately 88% of the total consolidated revenues. This growth was led by strong performance in U.S., Europe and key growth markets. The API business contributed to 12% of the overall revenues amounting to INR 961 crores, reflecting the ongoing market dynamics in the current pricing environment U.S. formulation. U.S. revenue stood at INR 417 million. Excluding gRevlimid, the U.S. oral solid delivered a healthy 6% quarter on growth, underscoring the strength and resilience of our diversified portfolio. This quarter also saw continued demand from our base business, supported by increased volumes and new product launches. Our U.S. injectable sales also grew by 6% quarter-on-quarter. During the quarter, we launched 6 new products, 13 ANDAs and received 7 final approvals, demonstrating robust pipeline execution and continued regulatory progress. European business. The European business maintained a strong growth trajectory, delivering 18% year-on-year revenue growth amounting to INR 2,480 crores. In euro terms, amounting to EUR 243 million this quarter. with consistent performance across all major markets, we are firmly on track to comfortably support the $1 billion annual revenue milestone by -- from Europe by the end of FY '26. Growth markets. Revenue from the growth markets increased by 9% year-on-year to INR 882 crores or INR 101 million, driven by strong volume growth and resilient commercial footprint. ARV formulation. ARV revenue grew by 69% year-on-year, reaching INR 325 crores or INR 37 million. This was primarily fueled by higher volumes and new tender wins across multiple geographies and we expect to sustain this momentum over the medium to long-term operational and financial highlights. Gross margins for the quarter stood at 59.7% compared to 58.8% last quarter. supported by raw material prices and the business mix. Gross contribution stood at INR 4,947. Excluding development, on a quarter-on-quarter, our sales have increased approximately by 7% and gross profit by 10%, our EBITDA by 14%, respectively. R&D expenditure was INR 414 crores, representing a 5% of the total revenue. thereby reaffirming our continued focus on innovation and advancing a robust pipeline of complex specialty therapeutics. Update on PenG. During the quarter, we started the operations of PenG on July 25 after getting the necessary regulatory approval. The scaling of the plant is as planned and is poised to make a meaningful contribution to profitability going forward. During the quarter, we produced around 1,050 metric tonnes by operating at 40% to 50% capacity, amounting to approximately 6,000 metric ton production on an annualized basis. It is pertinent to note that the yields are consistently improving. Like other companies, we have made a representation to the government to implement the minimum import price, which will support the further ramp-up in achieving 100% capacity utilization taking the production to 15,000 metric tons in a very short term. Next cap -- the net CapEx for the quarter stood at $106 million, in line with our strategic priorities of enhancing our manufacturing capabilities, strengthening complaints and accelerating automation. We generated net cash inflows before dividend $57 million during the quarter resulting in an improved net cash position, including investment $170 million as of September 30 compared to $140 million as of 30th June 25. Average finance curve declined to 4.7% in the previous -- compared to previous quarter, reflecting effective treasury and cash flow management. PAT for the quarter was INR 848 crores. Outlook. Looking ahead, we remain confident about sustaining our growth momentum and driving value creation across all businesses. Our optimism is underpinned by expected volume expansion and reasonably stable pricing in normal. Europe continued to deliver a robust revenue growth undergrowing the region's strategic importance and operational strength and market challenge to the company. In the U.S. data has transitioned into commercial phase with manufacturing interway packaging approval secured on product launches scheduled from January, positioning to positioning the rig to start contributing significant revenues in FY '27. Meanwhile, rallied awaiting regulatory layer. The OST facility in China continues to ramp up advancing towards the capacity of 2 billion backed by European approval, approval of 10 products and 3 local product approvals. The site is on track to deliver the EBITDA breakeven by Q3, Q4 FY '26, reinforcing its strategic importance to the global network. To summarize our next 2 years, our growth will be driven by several key factors, including ramp-up of our paint facility, commercialization of the biosimilar portfolio and rapid progress in our biologic CMO. We expect continued improvement in injectable business driven by continued supply ramp up, increasing supplies from China plant to Europe, additional contribution from a robust pipeline of new launches and the [ Lane ] acquisition in U.S., which will further strengthen our market position, expand our polio and drive medium-term growth. Last but not least, we are confident of achieving our internal margin target of 20% to 21% for FY '26 as communicated earlier. We remain focused on execution, operational excellence and disciplined capital management, all of which position us well for sustained performance in the coming quarters. We now look forward to taking your question. Our senior leadership team will be pleased to provide additional insight details and clarification wherever required. Thank you.
Operator
operator[Operator Instructions] The first question is from Damayanti Kerai.
Damayanti Kerai
analystHello. Am I audible?
Unknown Executive
executiveYes.
Damayanti Kerai
analystSir, my first question is on generic injectable business in the U.S. Sorry, I missed your comment. You mentioned it grew 6% quarter-on-quarter, so a few clarifications. Are we broadly back to the level where disruption happened? And how do you see this business shaping up in the next 2 years? And if you can just talk a bit about some of the key pipeline products, which you may have in your pipeline?
Puvvala Yugandhar
executiveDamayanti, still we are not back to the pre-disruption levels. I think we still have another $5 million, $10 million to go to reach that well, but it is mainly driven not because of existing products growth. But because we don't have new products to offset the single-digit price decline. We still have a quarter or 2 to go to come back to the pre-disruption levels. But the production is back on track, and there's no issue there. Going forward into the future, what we are looking at is, number one, on the injectable side, we have some interesting products. And hopefully, like guess reinspection and approvals. We have multiple products to launch. Second is with respect to our Vizag and visa commercialization and some new products coming from Vizag plant. And third, from a specialty portfolio, we have a lot of oncology oral solids, which we are expected to launch in Q4 and Q1 of next year. So the multiple levers going forward.
Damayanti Kerai
analystSure. And if you can just remind us about when you're expecting Eugia 3 reinspection?
Puvvala Yugandhar
executiveEugia 3, like we have already requested FDA and in the month of that is end of Q2. And now we have the confirmation from FDA granting reinspection for user. So normally, as per -- we received the official letter from FDA on 25th of September, that they have accepted our request for reinspection. So as for good for 3 guidelines, normally, it is anytime from now till -- for 8 months, okay? So they can come in any time for the inspection.
Damayanti Kerai
analystOkay. So majority of new logics, which we are expecting is broadly tied up to Eugia 3 clearance, right, if I understand correct?
Puvvala Yugandhar
executiveYes, injectables, yes, but not oral solid, mainly the oncology oral solids are all from Eugia 1. So I don't have any problem from Eugia 1. So those approvals will continue to happen. but Eugia 3, yes, part of injectables are from Eugia 3.
Damayanti Kerai
analystOkay. My second question is on PenG plant. Sir, you mentioned now that capacity has reached up to metric ton on an annualized basis, right? So when you go and discuss with government for the PLI benefit, what kind of scale up by then you are expecting? And what is the amount?
Santhanam Subramanian
executiveWe are not running all the fermenters. We are running only 40% to 50% of the fermenters. As and when we have represented to the government as an on any policy changes takes place, we will ramp it up in a very short time.
Damayanti Kerai
analystBut the current production, will that enable you for the PLI benefit or not?
Santhanam Subramanian
executiveThis current -- yes, it is enabling me benefit, not out of [indiscernible].
Operator
operator[Operator Instructions] The next question is from Neha Manpuria. .
Neha Manpuria
analystMy first question on PenG. So sir, what would be the EBITDA loss contribution from PenG at the moment? And at what level do we break even on the PenG plan? And second, let's say this MIP representation has not come to [indiscernible]? What's the plan B in terms of achieving breakeven? Does that impact your ability to ramp up the plant even if MIP gets delayed or does not come through?
Santhanam Subramanian
executiveSo it's a good question, Neha. As I explained to you, we have been improving on the yield, et cetera. We are nearing the breakeven, right, from the current operations, et cetera. We have been doing around 6,000 tonnes per annum. See, we are doing 500 tonnes per month. I can increase it to 800 immediately, not a big issue, right? One side touch 800, totally, it will contribute to the EBITDA. But having said that, we also need to look at it at what price we need to take that and move on. So that is what we are looking for the policy changes. As and when it happens, we will do that. As a plan B, what you are saying is we have been continuously working on improving the yields and other things. once that is going in a very positive direction has informed you in the life. So we are ready with the Plan B in case if there are any issues, but I don't think that is necessary, in my view.
Neha Manpuria
analystAnd sorry to have on this, sir. But what would be -- given where prices are for PenG and NGL products, are we still cost competitive if we get to 8,000 tonne per month reduction level, will we still be cost competitive to be...
Santhanam Subramanian
executiveYes. We are the biggest consumer of fixed APA, amounts, everything in the country. So we will, irrespective of that we will produce it and then we will consume it ourselves, right? That will help me in terms of improving the overall capacity utilization and that will take. And I also work on other necessary actions we will work on that to improve the capacity, which I would not like to share it now.
Neha Manpuria
analystUnderstood. Okay. Got it. And my second question is on the U.S. business. Swami, sir, are we seeing any change in the erosion trends. Actually, you Giner are we seeing any change in erosion trends in the market in the recent times? And obviously, one of our competitors have seen issues in their plant. How does that position us to probably scale up our business in the U.S. on the back of that? Any color there?
Swami Iyer
executiveNeha, I'm not sure I understood your question. You're talking about price erosion?
Neha Manpuria
analystYes. So my question is, have you seen any change in the price erosion trend in the U.S. in the recent months? And with this disruption in one of our competitors' plants, how does that position us to probably gain more volume in the market? Do you see that as an opportunity in the near term?
Swami Iyer
executiveSo when we take it as a basket, we think we are close to neutral. We have a little bit of erosion, which very low single digit. I would say it's closer to 1% in the -- for the quarter. And this is based on the overall basket of products, there are some increases. There are some decreases. However, I have to make one point here. We did have some product which were opportunistic, which for a limited period, you get some better opportunity in terms of pricing and volume. So those things, when they tapers down, when a compete comes in, those prices will go down when you had a single car or when you had just 1 completer later when somebody enters it could go down. So we have seen such phenomena of a few products. In any quarter, if you take, you will always have one product, which you have either got a shortage because of that, there are opportunities. and there are products which got. So net-net, I think we are still at a comfortable stage.
Neha Manpuria
analystUnderstood. And you can put any color from you on the injectable pricing? I think you said single-digit erosion? Has that increased in the recent months?
Puvvala Yugandhar
executiveIt is a similar trend. It's things as Swami rightly said, they can be one-off products here and there where the erosion can be higher or lower. But on an overall level, it is still single digit.
Operator
operatorRequesting participants to have 2 questions, please. The next question is from Tushar Manudhane.
Tushar Manudhane
analystSir, on the EBITDA margin first, like your guidance of 20%, 21% for FY '26, now that PenG plant is largely stable, closer to EBITDA breakeven, Eugia related operational cost is largely done, probably inspecting can only move up from -- in terms of profitability from here on. So if I have to extend this for maybe without considering the inspection outcome of Eugia, how do we see the margin trajectory from here on?
Santhanam Subramanian
executiveI think we will be able to give -- I mean, clear guidance once we come to know about the status of the PenG, right, which hopefully, it will happen very soon, maybe a month to 2 months time. So what we're able to tell you very clearly in the month of February.
Tushar Manudhane
analystGot you. So China plant operational cost, how much that is? I'm trying to understand...
Santhanam Subramanian
executiveChina, as on it, in the quarter, I'll be incurring your loss of around maybe $1 million but probably we'll be achieving -- able to achieve the breakeven between Q3 and Q4. And after that, China will start moving up in the overall contributing to the growth of the EBITDA growth.
Tushar Manudhane
analystGot it. In fact, trying to understand that even without, let's say, MIP related benefit on PenG, still how much is the scope to improve the EBITDA margin from the current 20%, 21% for FY '26 or FY '27?
Santhanam Subramanian
executiveSir, you are putting a lot of variables like to consider Eugia 3, don't consider PenG, then it will remain the same. Because these are all the key drivers which is expected to take it up in the next year.
Tushar Manudhane
analystUnderstood. Sir secondly, on Europe, which has been sort of a robust growth for now almost 3 years, and reaching $1 billion. So given this size of the business, we that we'll be able to still sustain mid-teens sort of growth over next 2 to 3 years?
Venugopalan Muralidharan
executiveSure. Yes, Tushar, thank you for raising this question. Just one interesting correction. We are now touching EUR 1 billion mark, whereas last financial year, we were at reaching distance of $1 billion. But no, we are well on track for EUR 1 billion. And yes, as you have seen in the last 3 years, Q-on-Q, we are demonstrating growth and considering my all major countries contributors in France, Portugal, Netherlands and Germany continue to demonstrate this growth statically. I am very confident in the coming quarters and period as well. There will be a sustained growth.
Operator
operatorThe next question is from Bino.
Bino Pathiparampil
analystSo sir, if I heard correctly, you said the EBITDA excluding Revlimid has improved 14% Q-o-Q. Is that correct?
Santhanam Subramanian
executiveThat's right. That's right.
Bino Pathiparampil
analystSir, what are the drivers of this? Is it mainly coming from lower losses in the PenG plant? Or is there something else to it?
Santhanam Subramanian
executiveThat was also one, and sales has grown up by about 7%. Gross profit also gone up by 10%. I think overall, there is an improvement across the businesses, which is what's driving the overall improvement of the EBITDA.
Bino Pathiparampil
analystOkay. And the gross margin Q-on-Q has gone up despite lower travel made. What has driven that? What has changed so much in the product mix? .
Santhanam Subramanian
executiveSee, one is if you really see the formation products have gone up this quarter compared to right? That is 1 small product change? And second, if you really see, Europe has been continuously growing. So it is -- the operating leverage is getting increased quarter-on-quarter, which is also helping us. And the third point is there is a product mix which is happening across U.S. is also right? I may not like to get into the details in terms of which segment, which product, et cetera. But there is a good amount of product mix is changing place in U.S., which is also helping. So it's a combination of multiple factors, which is helping to grow, I think. And the last one is, once the PenG comes, the gross margin will be very high because the major cost apart from the raw material is the [ pole ]. One -- so you're able to see a slight still a slight increase in the gross margin once the PenG plant comes fully operational. Once it's operated fully, probably we may cross 60% also.
Bino Pathiparampil
analystUnderstood. And Revlimid, was it minimal for the quarter? And are we completely done with it?
Santhanam Subramanian
executiveNo, it's a minimal for the quarter. .
Bino Pathiparampil
analystOkay. And then next quarter will be close to 0. .
Santhanam Subramanian
executiveYes. .
Bino Pathiparampil
analystUnderstood. And sorry, one last question on tax rate. For the first half, we have been at a tax rate about 30%. Is that likely to be the case for full year as well?
Santhanam Subramanian
executiveSo see, basically, some of the businesses are incurring losses, which you know that at a PBT level, like PenG, Life at some of the other businesses. We don't take tax credit on the losses. We will take only as and when it started making profit, we will adjust it. So because of that, it appears like we are having a 35% tax rate. But in reality, it's only 25%, whereas the tax returns will carry the losses as credit in books of account, we don't.
Bino Pathiparampil
analystOkay. So once they become profitable, the reported tax rate can fall below 25%.
Santhanam Subramanian
executiveBelow 25%, Yes, you're absolutely right.
Operator
operatorThe next question is from Tarang Agrawal.
Tarang Agrawal
analystA couple of questions specifically in U.S. How does [ Lannett ] help it improve, say, quantitatively and what are the steps to improve? And similarly, in Europe, things get a little complicated in Europe because it's a confederation of many [indiscernible] of the business continues to be reasonably high despite a reasonable amount of capacity, which continue to be unutilized. H1, it's already at INR 1,500 crores. So should we really now pencil in CapEx intensity for the business given a wash footprint of unutilized capacities?
Swami Iyer
executiveLet me talk about U.S. first after that, probably Murali can talk about or you can generally talk about other countries. As a U.S. is concerned, we have prescription of about 10.2%, which is the largest. So that tells you the coverage. It's very fairly large across all segments, and we have been growing. We've been growing now this quarter. We had -- we have seen some momentum in terms of seasonality. So that has also helped us that as far as the U.S. is concerned. And when you talk about lane-specific Lannett has a number of products, which are good additions to our portfolio like the ABSD products. And we are very excited to have those products in our preview as once the merger is done. We are still awaiting the FTC approval, as you may be aware. And that's a process we have to go through.
Tarang Agrawal
analystSir, if I could just chip in. I mean I understand that you've got north of 10% volume share but does it come after covering, say, 50% of the market? Or does it come after covering 60% of the market? It's really -- that's the metric that I was looking for.
Swami Iyer
executiveSo I didn't get your question. I don't know what is that 50% and 60% you're talking about?
Puvvala Yugandhar
executivePortfolio coverage, Swami. .
Swami Iyer
executiveOkay. So we are into all segments, all therapeutic areas. I would say that we are probably around 50% or more but it does not cover all the presentations of a product. For example, now home logistic form is one, some of the derma areas, we have still not covered so I would only say that we are in a significant. We have significant coverage in the therapeutic area. So I don't have the exact percentage, but that's where we are.
Venugopalan Muralidharan
executiveYes. So, Tarang maybe I can touch upon the European part of the query. Murali here. So you touched upon the portfolio bid and also the complexities in Europe under which we are operating in. So let me touch the second point. Yes, we are talking of multiple regulators, multiple language packs, different language packs and fragmented market. and different market architects, whether it is a tender the generic market of pharmacy-driven or prescription to well. Across all these, we have demonstrated our success there is a very well set system, front-end the commercial infrastructure, well-motivated team acting across these different markets. that way we are able to overcome the challenges. In addition to the regulators, we are also an set the European Commission, European Medicine Agency, newer challenges like on nitrosamines, we keep hearing, but we were able to overcome all these with all of our efforts. Coming to the portfolio on the representative market, if you assess, we are on upward of 80% of portfolio coverage. And we are constantly striving to touch that 85% to 90% levels. Of course, here, I have excluded biosimilars and inhalation products. But there, again, very soon, we will be making our launches.
Tarang Agrawal
analystSir, when you say represented markets, what do you mean? Because I felt there was an astric to adding you called the term represented markets.
Venugopalan Muralidharan
executiveThe way I qualify telling some of the biosimilars range and inhalation range. which I excluded. But otherwise, the generic-generic market in which we are operating in, we are able to have over 80% of the portfolio addressed.
Santhanam Subramanian
executiveTarang, in terms of the CapEx, we are -- as we communicated, we are not going for any major greenfield projects, et cetera. What we have done, the major CapEx during the quarter is on account of we have increased -- we entered into an arrangement with a global pharma measure for which we have to pay the milestone payments, which we have been doing. Plus, you know that the U.S. also has put the new warehouse and other related things. And we are also going to incur going forward on the biologics, which Satakarni can give more color into that. So otherwise, we are not having all our minor CapEx which are going on. There is no major CapEx. Only these 2, 3 things will only contribute to the CapEx going forward.
Tarang Agrawal
analystYes. Any comment on biosims because you specifically spoke about CapEx there, sir? .
Makkapati Satakarni
executiveIn biosimilars. As you noted, we have invested in capacity expansion 1.5 years ago. So this is not a new CapEx per se. We -- I told you in the earnings call sometime back, that we have we are adding 2 250-liter mammalian bioreactors to the existing curate facility. Now after 18 months of the CapEx approval or maybe 2 years of CapEx approved, those lines are now getting commissioned. Likewise, to make us commercial ready and to ensure a good supply chain we also needed to add filling capacities. So as part of the last year's 2024 CapEx approval, we are adding a wild filling line to the filling capacities at CuraTeQ. So those equipment will come online. I think the bias will come online. We're fully commissioned and qualified this quarter. The filling line will be fully online and qualified by June or the July quarter of next fiscal. With respect to Theranym, as you know, that's 1 of the CapEx investment for Aurobindo. As I told you, the company committed a capital investment of about INR 1,000 crore to establish 2 to 150 mammalian bioreactor commercial scale facility. Theranym continues to make steady progress on executing this project. And I believe this project will be ready for inauguration, some time in June, July next year. So that's the CapEx exposure that we continue to have. During the last quarter, we further strengthened the collaboration with MST by signing a second product contract with them. To support this expanded scope, 2 additional 150 mammalian bioreactor lines are being added as part of Block II in the same facility. So that's some of the CapEx exposure that you will be witnessing Otherwise, what our CapEx commitments that Subu has been talking about, the fiscal prudence in terms of expenditure is extremely tight at our into. So we are very conscious of the fact on the question that you have raised. And we are maintaining prudence in expanding.
Tarang Agrawal
analystI don't know if this was called out before, but congrats on the expansion of scope with MSD.
Operator
operatorThe next question is from Shyam Srinivasan.
Shyam Srinivasan
analystJust sticking to biosimilar commercialization and even the pipeline updates, if you could share, please?
Makkapati Satakarni
executiveSo it's pretty interesting in terms of the last quarter that we had, we announced a successful Phase III clinical study outcome for our [ denosumab ] biosimilar. We conducted a Phase III trial entirely in Europe in 446 patients enrolled across by European countries and I think 40 clinical sites. We are working towards submitting the marketing authorization applications for denosumab, biosimilars, both for Prolia and [indiscernible] biosimilars to European Medicines Agency in April 2026. Now I have given this guidance before that I would like to submit the MAA application in January, but considering my other clinical commitments from the facility availability, the validation batches are taking time. So April is when the European submission for this biosimilar will happen. And the FDA submission, we think that we can be able to do it in the July quarter of 2026 calendar year. So this is a good development for us. Likewise, [ omalizumab ] which is a very important product, a biosimilar to [indiscernible], we have successfully completed patient recruitment in our Phase III trial. This is in chronic spontaneous urticaria I believe that we'll be ready to submit the European marketing authorization application in June, July 2026 and a quarter later in the U.S. So we are on track with this product. An important development is for tocilizumab, which hit the 2 was not part of our regulated market plans. We have completed a clinical PK/PD study for tocilizumab already. So we went to European Medicines Agency. My regulatory team was able to get a Phase III clinical study ever with the European Medicines Agency, which means that now we are doing everything to fast track tocilizumab, which is also immunology product. We believe we will be able to submit this product also in the July quarter next year with the European Medicines Agency. We will start engaging with the U.S. FDA to discuss about the possibility of a Phase III clinical study waiver for tocilizumab. So tocilizumab, I haven't talked about this product before, but now this comes into the filing domain in the next year from us. [ Bevacizumab, ] there's an interesting update. You know that have completed a Phase I study, and we have got an approval for our [indiscernible] biosimilar in U.K. Last I'm told it's already available in hospitals in U.K. for purchase from yesterday. With European Medicines Agency, we had a scientific advice, and we received a waiver for Phase III clinical study, which means that I need not wait until the study completion, which is late next year to submit the file with Europe. We will be able to also submit this file. We are planning to submit file in April 2026 with Europe. With U.S. FDA, we still believe for this product because it doesn't have a good marker. We still believe the Phase III study will be relevant. So the U.S. FDA filing plans don't change, that will be towards the end of the next year. So you can see the portfolio is progressing really well. To your second question, Shyam, on the launch and supplies. We are pleased to share that we have successfully invoiced and delivered our first batch of biosimilars in the European market. which is an important milestone. Currently, we are focusing on streamlining our testing activities with the CRO partners to ensure timely testing and compliant QP release of products. At the same time, we are also actively aligning our manufacturing and supply capacities so that from March 2026, we will be able to supply continuously to our European partners. Also, what is important to note is we are in the process of negotiating a couple of strategic deals in European market that will broaden our product portfolio and maximize our supply potential. We expect to share more clarity and details on these developments in the next quarter. Overall, I remain confident in our European software road map and also the emerging market road map that we are putting together, and we are committed to delivering value to patients and Atlas from 2026 onwards. The; 27; 28, which I always told will be the inflection point in the biosimilars business, where I expect about 7 approvals in Europe and possibly a couple of approvals in the U.S. on the upside. I hope this answers your question.
Shyam Srinivasan
analystJust one sub question is on the new biosimilar guidelines in the FDA. And from a competitive intensity, standpoint, do you now see a lot more of your peers who have probably skirted this opportunity? I'm talking Indian peers to start looking at it seriously. And are you worried about it at all?
Makkapati Satakarni
executiveIt's a very interesting question. I can give my perspective. In October 2025, the FDA leased a new draft guidance aimed at streamlining and simplifying the biosimilar approval process. Now the way I read the guidance, the draft currencies -- the key regulatory shifts, the language is important. Please read the language that I'm talking about. The key regulatory ships include reducing the land so on comparative efficacy studies. So it's not about eliminating comparative efficacy studies at this point. But eventually, just like Health Canada, European Medicines Agency. And , I believe U.S. FDA will also reach a point where we need for Phase III efficacy studies will be removed. But right now, it is about reducing the leaner efficacies and eliminating the requirement of interchange. And if you are following my earnings calls for the last 2, 3 years, I've been telling that the ethane designation will go. So that is happening. So there is a clear mandate on eliminating the requirement for interchangeability stories, and I have not invested in any interchangeability of switching studies in my portfolio and reducing the ransom comparative efficacy studies. The part 2 of your question, by reducing the developmental hats and costs, do you think there will be a peer group that can essentially bid capabilities and deliver biosimilar on a day-to-day basis. I believe that the entry barriers are still on the science. Developing a biosimlar is more akin to developing a biologic minus the discovery. So the barrier and initial of good science to be able to leverage a strong analytical and competitive data expertise still remains a significant barrier for most companies. I can comment on CuraTeQ. CuraTeQ has already demonstrated a proven biosimilar developmental capability with approvals in Europe. And therefore, I believe our business is well positioned to benefit from any removal of the need for doing comparative efficacy studies. The time lines will definitely shrink. But the inertia that you have in terms of being able to characterize the biosimilar analytically, so that you can have the waiver for Phase III on a case-to-case basis still remains a significant barrier for most companies' shell, if that answers your question.
Operator
operatorThe next question is from Kunal Dhamesha. .
Kunal Dhamesha
analystSir, since we are quite confident of getting minimum import price for PenG. If you could highlight that would it be only for the PenG HS code. And secondly, what is the range that we are looking at? What is the representation that we have made in terms of what should be the minimum import price, that would be helpful.
Santhanam Subramanian
executiveKunal, all the questions are very relevant because it is already in the review by the DOP, right, and the government, we're not able to comment any of your process. Ultimately, the range, et cetera, it is there prerogative. What is that they're going to give, et cetera, is that prorate? We are making a presentation. We have been taking up with them, et cetera. But ultimately, as and when they inform us only, we'll be able to communicate.
Kunal Dhamesha
analystOkay, sure. And let's say, MIP ideally should not have any impact on the internal consumption of PenG for us, right? It only kind of should affect the external sale. Is that the correct understanding?
Santhanam Subramanian
executiveNo, it is not correct to understand because once again, it is linked to your first cost. Your understanding is not right, but I will let you know after some time because it is linked to the first question.
Kunal Dhamesha
analystOkay. I still don't get it. So yes, because internal consumption would not get impacted by MIP.
Santhanam Subramanian
executiveInternal consumption, is it you have to look into the supply chain as a whole, PenG, fixed API, amoxi like that it goes into multiple layers. So that is the reason.
Kunal Dhamesha
analystBut we should be able to offset our internal consumption of PenG or 680?
Santhanam Subramanian
executiveNo. Ultimately, if you really look at it, everybody -- I mean, the presentation includes amoxi. That is having a bearing on the market place where we both converge both external and we. You got it?
Kunal Dhamesha
analystYes. But for us 6-APA shouldn't be an issue, right?
Santhanam Subramanian
executiveIdeally, it should not be an issue. .
Kunal Dhamesha
analystOkay. So MIP is not basically leading to that internal consumption, amoxi maybe, not 6-APA?
Santhanam Subramanian
executiveI will explain to you. Give me a week's time. I'll explain to you.
Kunal Dhamesha
analystSure. Sure, sir. Sure. And secondly, for Satakarni, sir, would you say with all these changes in regulatory potential changes in regulatory landscape? Would you say that the plant compliance and good manufacturing practices would be the primary entry barrier for the new player for the biosimilar business? Given that PK studies, et cetera, it's not, those are not very costly to conduct.
Makkapati Satakarni
executiveYes. I mean I'll repeat my answer. So there are 3 things here. One, you need to be able to develop analytically high-quality biosimilars. So that's the first barrier. So because if you develop a high-quality biosimilar that is characterized to well service originator by logic. The chances are, on a cash-to-case basis, you will get a Phase III waiver, which means that the companies which were investing anywhere between $50 million to $150 million in conducting these clinical strategies don't need to expand that much now. A PK/PD study with a strong immunogenicity data package. The immunogenicity requirements, I believe, will increase go. But having said that, the time lines will shrink, the investments will no longer be required to the extent that they were -- we were making before. So all this is good. And the third barrier would be the GMP. So that's a given for any product that goes into a patient, the regulatory norms in terms of good manufacturing practices continue to be of the highest scrutiny and ticket. So every company had to meet those. So I still think the signs to get a biosimilar relatively characterized companies who have achieved that sort of resource capability building in their organizations, stand well positioned to take advantage of these shifting regulatory norms, be it in -- with the FDA with EMA or Health -- and when you have good GMP tiers that go with it, then the approval pathway will become easier. I hope this explains your answers to your question.
Kunal Dhamesha
analystSure. And sir, lastly on where do we stand on the plant inspection from U.S. FDA perspective? I mean what is our preparedness here? When do we expect our first filing and U.S. FDA to inspect the plant?
Makkapati Satakarni
executiveSo based on my earlier guidance, I was hoping to file trastuzumab with USFDA, but considering my supply commitments and it's a lie-flat product recalibrating my capacities and the utilization ideally is that I will push down trastuzumab to the later half of next year. So the first filing would now be followed by omalizumab. So if you file it somewhere between April to June, then I expect the inspection to happen by the end of the calendar year 2026 with the U.S. FDA.
Kunal Dhamesha
analystThat's helpful. And all the best.
Operator
operatorThe next question is from Nitin Agarwal.
Santhanam Subramanian
executiveNitin, can you hear us? Can I go to the next question, and then I can come back.
Operator
operatorThe next question is from Surya Patra.
Surya Patra
analystMy first question is on the European market. Is it possible to announce share what is the injectable revenue mix within Europe now? And what is the margin performance for the entire European business now we are having?
Makkapati Satakarni
executiveYes. The injection component is about 10%. We are touching a $100 million mark. Here, what I wish to state is not all of the products are in copious supplies. We are waiting for some of these products to kick in from D3. So at that time, we will be having a quantum jump that we expect and of course, the margin percentage wise, yes, we were using at 20 levels it.
Surya Patra
analystOkay. So means, we are anticipating to reach towards 20 level, but currently high teens, that is a reason.
Makkapati Satakarni
executiveYes, that's right.
Surya Patra
analystOkay. Second point is that we are seeing a kind of interesting development on the growth market front by creating multiple kind of fully in subsidiaries like that. So could you discuss something your kind of moves and initiatives on the growth market side? And what is the kind of a growth trajectory that you are now thinking there? Any specific strategy change on those market trends anything on that front, sir? Having created a significant presence in U.S. and Europe?
Santhanam Subramanian
executiveSurya, on the overall, if you take the rest of the growth markets, see the growth markets are not concentrated in one and it is across all the things. And where we are having a looking for a good impact coming next year is the China one. That is one thing. And other markets are like Canada, Brazil, I think all the markets are growing reasonably well, and there is no specific one market is growing like that. except the new market, which is going to add to the volume -- I mean, top line as well as the EBITDA level is the China one, which we had talked about it earlier.
Surya Patra
analystOkay. So is it right to think this way that given the large volume opportunity in the name of the GLP, what is upcoming. So to participate there actively in the majority of the emerging market, are we becoming but aggressive and hence, creating platforms and the presence and positioning and also what is our thoughts about India about GLP also, if you can -- you go there on the GLP, please?
Puvvala Yugandhar
executiveNo. On the GLP piece, I think we have been very clear that we will be doing this on at our Vizag plant, and we will be in the second phase of launches. And we will -- we are looking at filing the products across all markets sometime next year.
Santhanam Subramanian
executiveOn the India front, probably we may do some small acquisitions may not be a big one. We'll not do a big 1 because we'll just need to I mean, slowly take for the Indian market. As of now, we are doing around a turnover of something like INR 275 crores to INR 300 crores per year. And probably, we may take it to buy another INR 100 crores like that only we will do. So we'll not go aggressive on the Indian market.
Surya Patra
analystOkay. Just last one bit, sir, about the acquisition plan for the capital allocation plan. So we have been acquisitive also. So do you have any plans for any larger acquisition if that is possible? Or what would be our thoughts about inorganic growth going ahead?
Santhanam Subramanian
executiveCertainly, wherever we are getting opportunities which create a new market or new technological platform, which will add -- I mean will not go on then to specifically for the existing products. wherever we get like Lane, the example of [ lanai ] leader in the control substance. So like that we have done. So we look into case by case, and there is no specific. This is what we are going to do like that.
Operator
operatorThe next question is from Kunal Randeria.
Kunal Randeria
analystSir, my question is regarding some of your new plants. So for example, in China, you will spend around $145 million. So I'm just wondering what kind of asset turns should 1 expect? And when can this plant achieve its peak sales potential?
Santhanam Subramanian
executiveI think the plan is the plant started invoicing since April this year. And within this year, we are able to get -- we are able to achieve a breakeven in the first year it -- and going forward, what we are trying to see is in the next 3 years, we should be able to take the turnover to triple digit beyond triple -- I mean, into a triple digit, which will help us to achieve a significant because the margins because generally, the productivity there is high and the margins will be good. So we are trying to -- in 2 to 3 years' time, we were able to achieve triple-digit turnover number.
Kunal Randeria
analystSo should I kind of assume in 3 years or so, you could have an asset turnover around maybe $50-odd-million is potentially likely number?
Santhanam Subramanian
executiveCould be.
Kunal Randeria
analystSure. Sure. And secondly, sir, you did touch upon this M&A that you are looking to do. But there was some news item earlier that you were looking to buy [ Zentiva ] and the rout could be like as much as $5 billion. So is this the kind of scale that you are comfortable doing?
Santhanam Subramanian
executiveNo. As I said, first of all, we said very clearly, we have not given any binding offer okay? Second is, it is not that every M&A, which we are looking into that, we are going to buy it, will it go case by case? And what are all the synergies, how it will help the company as a whole institution as a whole. And what are all the new technological things which we are able to achieve new market trends, right? In the case of Zentiva, I made it very clear in the last call itself, we are not present in Central and Eastern Europe. It has come very handy. So that is a one-off case. I need not be everything will be like Zentiva.
Kunal Randeria
analystSure, sir. No, I understand that. My question was more like would you be comfortable spending levering up and maybe going for a $4 billion kind of an acquisition, that's more -- not TV-specific but more like a $4 billion kind of payout? Would you be comfortable doing that?
Santhanam Subramanian
executiveNo. See, Zentiva also, if you really see, assuming INR 4 billion, we haven't given any numbers, assuming EUR 4 billion. interest coverage will be more than 2.5x, even assuming 100% leverage. So the -- it all depends upon the case and rent is a very unique case. That's what I've been telling you.
Operator
operatorThe next question is from Nitin Agarwal. We will move on to the next question. The next question is from Bino.
Bino Pathiparampil
analystOne question on the biosimilars layer. In your understanding why the time you reach market, how many other players would be there in the U.S. market?
Makkapati Satakarni
executiveIt depends on per product, Bino. So with omalizumab, which is our primary product for the U.S. market, a potential $4 million Global market is around USD 2.5 billion to USD 2.6 billion coming from the U.S. alone. We will be the third player. As of today, we'll be the third player. The product is in 2 indications: chronic spontaneous urticaria and respiratery recently, the novated also got an approval or accidental food allergies which is supposed to grow the market significantly. Now when you come to denosumab, the patent expiry is towards the end of this year. We expect biosimilars to shape the market in the next 12 to 14 months. So I am not in the first wave of product launches. We will be in the second wave. But we believe any biasing at these days that you look at from the analytical reports is dial reports, et cetera, even those with patent expiries beyond 2028 or 2030, there are at least 8 to 10 players who are developing them. So I believe the gold post has slightly shifted from attempting to be the first one to launch. Aurobindo is not at this point of time because we have at least a decade and decade and of lag time in catching up with competition who have started warhead office, we were there for the last 6, 7 years, and we started this count. But we will be cost competitive. We would be the last standard. And we would like to shape the market in a manner that we can sustain our efforts over the long term. We are picking products that we believe have a longer product life cycle in terms of the patient care and management, which means the follow-on biologicals are not really exciting. So such products make our portfolio. So in some products, we may be in the 3 or 4 to be there in the market in some products, we may be 6 or 7 to be in the market. So it really depends on the product now.
Operator
operatorThank you. Any closing remarks, sir?
Santhanam Subramanian
executiveThanks, Vandit. Thank you very much, everyone, for joining us on the call today. If you have any of your questions unanswered, please feel to get 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, everyone, once again, and have a great day ahead.
Operator
operatorLadies and gentlemen, on behalf of Aurobindo Pharma, that concludes today's conference. Thank you for joining us, and you may now disconnect your lines and exit the webinar. Thank you.
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