Good morning, ladies and gentlemen, and welcome to our fourth quarter FY 2026 and full year FY 2026 earnings call. I'm Varun Mali from the Investor Relations and Corporate Communications team. We hope you have received the Q4 FY 2026 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 who's on the call with us today, represented by Dr. Satakarni Makkapati, CEO, Aurobindo Biosimilars, Vaccines, 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 have also requested Dr. Ashish Anvekar to join us for any questions related to Acrotech Biopharma USA.
We will now 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 development, and commercial performance. While these forward-looking statements exemplify our judgment and future expectations concerning the development of a business, a number of risks, uncertainties, and other important factors which may cause developments and results to vary materially from our expectations. Aurobindo Pharma undertakes no obligation to publicly revise any forward-looking statements to reflect any future events or circumstances. With that, I will now hand over the call to our CFO for the business highlights. Over to you, sir.
Thank you, Varun. Good morning, and a warm welcome to our Q4 FY 2026 earnings call. I'm pleased to begin the call by sharing that the company has delivered an excellent quarter and a strong financial year, underpinned by sustained growth and reflected in our highest ever revenues and highest ever EBITDA margin, both quarterly and annual. For FY 2026, revenues stood at INR 33,653 crores, while the EBITDA came in at INR 6,856 crores, translating into a healthy EBITDA margin of 20.4%, which is in line with our revenue as well as EBITDA guidance for FY 2026, supported by favorable product business mix and other factors. For Q4 FY 2026, revenues were INR 8,853 crores and EBITDA stood at INR 1,801 crores, resulting in a robust margin of 20.35%.
During both the quarter and financial year, we witnessed good performance across our businesses, primarily driven by stable volumes, new product launches and sustained momentum in regulated markets supported by pricing conditions. Despite insignificant development product sale compared to Q4 FY 2025, EBITDA before ForEx remained flat year-on-year growth and grew by 2% on quarter to INR 1,801 crores. Net profit increased by 2% year-on-year to INR 921 crores. For the full year FY 2026, the revenue grew by 6% year-on-year to INR 33,653 crores. Ex gRevlimid development, our full year revenue growth was 9.5%.
For Q4 year-on-year, ex gRevlimid development, growth was 15.3%. In USD terms, it was 7%. Gross contribution also reached the highest ever absolute level of INR 20,165 crores, reflecting margin 60%. That is an improvement of around 100 basis points. The EBITDA before ForEx and other earnings grew by 4% year-on-year to INR 6,856 crores. Formulation business.
Let me now take you through the business highlight, formulation business. Formulation business in Q4 FY 2026 witnessed a growth of 5% year-on-year to INR 7,646 crore and contributed around 86% of the total revenue. The revenues are mainly supported by growth across the market. API business. For quarter, API business contributed around 14% and revenues improved by 25% quarter-on-quarter to INR 1,208 crore. For the full year, API business contributed 12% and profit revenue of INR 1,447 crore. U.S. here. For the quarter, revenue from U.S. formulation remained flat. On a constant currency basis, U.S. revenue decreased by 18% year-on-year to $387 million. This is mainly on account of high gRevlimid development sales in Q4 FY 2025. Our large product portfolio helps us to optimally maintain the price stability.
Revenue from U.S. formulation for the year remained at INR 14,408 crores to, or $1,631 million, with the growth primarily accounted by lower gRevlimid revenue. Europe. For the quarter, Europe Formulation clocked INR 2,795 crores, an increase of 30% year-on-year. In constant currency term, the Europe revenue was EUR 261 million against EUR 236 million of Q4 FY 2025. The growth was driven by robust performance across all key European geographies. First time we have achieved for the full year, Europe Formulation achieved a significant milestone of EUR 1 billion revenue in terms of annual revenues. Growth markets. For the quarter, growth market revenue stood at INR 980 crores with a year-on-year growth of 25%, and quarter-on-quarter growth of 13%. For the year, growth market revenue was increased by 10% to INR 3,499 crores.
In U.S. dollar terms, revenue growth to $397 million from $376 million in the previous year. ARV business. For the quarter, ARV business revenue increased by 6% year-on-year to INR 328 crores, or $36 million. For the year, ARV revenue increased by 33% to INR 1,384 crores, or $157 million. Driven by continued business opportunity, partly offset by pricing pressures. Specialty and injectable. For the quarter, global specialty and injectable business reported a revenue of $122 million. Ex gRevlimid development products said the growth business grew by 13% year-on-year. For the full year, revenue stood at $513 million. Ex development growth was 12%, mainly due to improved supply of new product launches, partly offset by pricing pressure. Going on to other highlights. The growth contribution stood at the highest ever absolute levels of INR 5,424 crores.
Gross margin stood at 61.3%, increasing by 153 basis points quarter-on-quarter. R&D expenditures stood at INR 400 crores for the quarter. For the year, R&D expenditures stood at INR 1,590 crores, which is 5% of revenue. Net CapEx for the quarter is INR 82 million, and for the year around INR 341 million, which includes capacity enhancement projects and plant expansions and CDMO projects. Improved profitability coupled with improvement in working capital, the business generated a net cash inflow after payment of purchase consideration of Khandelwal Laboratories, non-oncology business around $32 million. As a result, the net cash position of the investments at the end of March 2026 improved to INR 317 million from the net cash position of INR 276 million in December 2026. The average finance cost was 5%. Outlook. As we look ahead, we remain encouraged by the stability across our core businesses and the continued progress on our strategic priorities.
Our diversified product portfolio continues to provide a resilient and balanced earnings profile with no disproportionate dependency on any single product or geography. Coming to the U.S. business, we continue to see multiple growth levers through the expansion of the basic businesses, new product launches, that is the topical ointment, ongoing acquisition, Lannett, and the expanding pipeline across oral, transdermal and respiratory products from our Dayton and Raleigh facility. With these initiatives, our U.S. business is aiming to touch $2 billion revenue milestone over the near term. Europe continues to remain a strategic growth engine for the company, supported by portfolio expansion, improving market penetration, reliable supply capabilities, and stronger customer relations. We expect the business momentum in the region to remain strong going forward.
From a long-term value creation perspective, we continue to focus on improving the quality and the predictability of the earnings through balanced mix of scale, specialty, and operation. Our biosimilars and biologic CMO strategies continue to progress well and represent important long-term growth drivers alongside our core generic franchise. Geographic expansion across the growth market remained a key strategic priority, supported by focused launches, portfolio expansion, and selective acquisition. Our China OSD facility continues to scale up steadily with the increasing approvals and supplies into international markets, particularly Europe. India business is evolving into a new growth engine for the company, further strengthened through recent acquisition, continue to expand through new division, wider therapeutic presence, and deeper pan-India reach. Our backward integration efforts across Pen G and 6-APA and Amoxicillin continue to strengthen supply security, reduce import dependency, and improve long-term margin profile.
Based on current operating level, we expect analyzed Pen-G production to exceed 10,000 metric tons with a capacity utilization levels exceeding 80% at consistent yields. Overall, this initiative provided strong visibility on the revenue growth, profitability improvement, and cash flow generation over the coming year. Going forward, we remain focused on disciplined execution, operational excellence, prudent capital allocation, and sustainable long-term value creation. FY 2027 financial outlook. We firmly believe that the business is entering into the next phase of calibrated and profitable growth with visibility towards stronger revenue growth. We expect the EBITDA margins to sustain and progressively improve to north of 21%, reflecting the scale of our operations, execution capabilities, and leveraging the new business levers. That concludes my remarks. We'll be happy to take your questions. Thank you.
Thank you, sir. We will now open the call for Q&A session. We will wait for a few minutes until after the queue assembles. We request participants to restrict to two questions and then return to the queue for more questions. Please raise your hand from the participant tab on the screen to ask the questions. The first question is from Joseph Sheikh.
Good morning. Thanks for the opportunity. Your operating cost, excluding R&D, has increased 11% QOQ and 17% YOY. Can you throw some light on this? Can you tell us is there any one-off element over here for the quarter?
See, the one-off element will always be there in terms of the year-end provisions, et cetera, that becomes a routine thing. What is the main factor which has increased the cost, other expenses cost, it includes the power and fuel, predominantly power and fuel consumption for the Pen-G plant, which has taken off very significantly in the last quarter. That is the Q4 of this quarter. That is the reason why it has increased.
We should expect this rate to continue going ahead?
Yes, it will continue like this because now what is happening is we are using our own 6-APA for our captive consumption, we are not buying it from the imported material. Since because of that, our raw material cost will come down and the other expenses goes up. That you can see very clearly why our gross margin also improved by about a percentage.
Yeah, that's helpful, sir. My second question, can you tell us how much EBITDA loss you have incurred in FY 2026 from your new projects like PenG, Eugia sterile, biosimilar, and China facility? Do you expect most of the projects to turn breakeven in FY 2027?
Yeah, I think if you take PenG and 6-APA put together, we have got a positive EBITDA contribution last quarter. That is mainly because of the higher operating leverage, and we have started getting better yields now. That is the thing. We expect this to continue for the coming years as a whole. Last year as a whole, we would have incurred around, must be around INR 200 crore plus EBITDA loss on account of PenG, Lifos and Q. In terms of the China plant also, we incurred loss, which is expected to do a profitable EBITDA contribution this year.
Okay, that's helpful. I'll get back in the queue.
Yeah.
Thank you. The next question is from the VNT Knowledge.
Hi, good morning. My first question on the U.S., where you mentioned you are looking ahead for this $2 billion mark in near term. Any timeline for that?
Swami?
Well, we can't say any time. Be it in the near future, probably in the next maybe 2 years, I would think. Our confidence is based on what's going on in terms of acquisitions and some of the Business Opportunities that we have.
Okay. Directionally, you are looking at this INR 2 billion mark maybe couple of years down the line, not in immediate or medium term?
Yeah.
Okay.
What Swami say is, if acquisitions materialize, we may move towards that very fast.
Okay. On that note, are you on track to close the Lannett deal as indicated earlier?
Yeah. Probably, there'll be some difference in timing. We'll probably close by Q2 of the current fiscal. What we didn't factor in was the government closure for 76 days between February and April. When the government shuts down, the FTC does not function. I think the first time we had some flexibility, the second time it was very long, and it took 76 days. I think they've largely made up the time. There could be some delay, I think early Q2 may be a better estimate. We feel fairly confident about that.
Okay. That's helpful. Thank you. My second question on Europe business. Where you have now marked 1 billion milestone there, and when we look at the sales in EUR term, last two quarters, you were somewhere in EUR 261 million range. Can you directionally indicate how things will move up from here? I understand supply from China will be a big contributor. As we anticipate higher supplies from China, how should we look at, say, 2027 from Europe business perspective?
Good morning, Muralidharan here. Yeah.
Hi, Murali. Yeah.
Hi. Thank you for this query. Yes, having achieved the INR 1 billion milestone, which we had taken up on ourselves as our mission for FY 2026, we are definitely bullish. We are very confident that we'll be moving northwards of this base business that we have achieved. Contributions from China, I mean, already more than 10 products have kicked in some form or other, whether it is a new launch or tech transfer products, and progressively, that will increase and contribute to the Europe business. We are quite confident that despite the geopolitical issues, we will be growing further in the base that has been built.
Any indication on the growth rate, say, we can comfortably target for double-digit growth, say, low double digit to mid-teens or any number you would like to share?
We are definitely trying to achieve the double-digit growth. Of course, considering the current geopolitical situations, we have taken it bit conservatively, but we are confident it'll be minimum double-digit.
Sure. Thank you. I have more questions. I'll get back in the queue.
Thank you.
Thank you. The next question is from Charu Agarwal.
Thank you, sir, for taking my question. My first question is on the biological CDMO unit. When do we start seeing it commercializing, and when do we expect the first revenue from the segment?
About the CDMO unit, the unit one will be commissioned by end of this year. My guidance around the first 60 KL capacity installation commissioning remains the same with the PPQ batches, which are the validation batches scheduled in 2027, and the filings in the markets by the customer also slated to happen.
In 2027, we expect some stockpiling requirements from the customer in 2028. A steady stream of revenues, to answer your question, would begin in unit 1 from 2028. With respect to the recent product schedule 3 that I have signed and we have informed the exchanges about, that's a greenfield drug substance manufacturing facility. We expect to close the commissioning of the facility in 2029. 2 years from then, 2031, would be the start of revenues from unit 2. In a nutshell, between unit 1 and unit 2, you would expect the revenues to kick in from 2031. Unit 1 will have a head start from 2028.
Thank you, sir, for this. My next question is again on the Pen-G. When do we start the external sales from the unit? While it has been contributing to the internal supply, but when do the external supplies start?
The external supply has already been happened in the last quarter. We have sold more than INR 100 crore worth of material in the last quarter, both Pen-G as well as to the outside market. We also already informed all the customers that they can pick up the material because some stock were there in the market earlier because of the high imports in the Q3 of this year, FY 2026. We expect the offtake will take up strongly in the coming days, coming weeks.
Okay. Thank you so much. That was my question.
Thank you. The next question is from Surya Patra.
Yeah. Thank you for this opportunity, sir. My first question is on the European business. Congrats for the $1 billion milestone mark that you have achieved. If you can update, what is the EBITDA %?
Surya, EBITDA is just in excess of 20%, and we'll be moving onwards of same, as stated by our CFO.
Hello?
Hello. I hope you could hear.
I am able to hear.
Yes.
Yes.
I think there is some network issues with Surya's network. We will move to the next question. Next question is from Rahul.
Hello. Yeah. Hi, sir. Thanks for taking my question. Sir, I guess your $2 billion revenue guidance for the U.S. business factors in Lannett as well, which alone should contribute to $300 million incremental sales. With that, you should get to $1.9 billion-$1.95 billion. This guidance is essentially driven by Lannett. If you can also talk about how do you expect the base U.S. business to grow ex of acquisitions?
Subbu, I'll take this question, okay?
Yeah.
First of all, Rahul, Lannett is probably going to be there for 2 quarters in the current fiscal. This is going to be half of Lannett, right? That's number 1. Number 2 is, that is also subject to approval, which we expect, which we are confident. That is 1. We are looking at some business opportunities. Those opportunities, we believe that we are in a good position now. We had to be, timing-wise, I can't tell you for certain, but we are heading towards a $2 billion goal, and Lannett is part of it. Maybe in the next 1-2 years, definitely we are getting there. You're already aware that Lannett is about $300 million. Obviously, we should be heading towards that $2 billion mark in the near future. That's all I can say.
Maybe in one year plus, maybe in one year, if we are lucky. It depends on the FTC approvals and some of the business development deals getting operational.
Sure, sir. These business opportunities, so are these NBOs which you are targeting or these would again be, let's say, M&A kind of opportunities?
It's not NBOs that I'm talking about. It could be business opportunities in terms of in-licensing or we are not going for any big bang acquisition, at least I hope we are not. Right now, we are in the process of doing Lannett acquisition. That needs to be completed. We do look at opportunities of some in-licensing and some NDA acquisitions. That's ongoing. We are focusing a lot on business development in the U.S. in addition to our own products. That's why I feel confident that sometime soon we will touch that $2 billion mark that Subbu mentioned. Whether it's going to happen in 1 year, I don't want to commit that at this point. Maybe we'll have a better sense in the next 1, 2 quarters.
Sure, sir. Sir, my second question is with respect to the guidance for the European business. You talked about cautiously looking towards a double-digit kind of a growth. Can you clarify, that's in constant currency?
Yeah, it is.
Okay, sure, sir. Thank you. That is it from my side. Thank you.
Thank you. The next question is from Nitin Aggarwal.
Hi, sir. Thank you for taking my question. Sir, on the biosimilar business, you've highlighted a FY 2030 vision or a 2030 vision for the biosimilar business. If you can probably just articulate in terms of what are we looking at, especially in terms of number of products being marketed, commercialized by then, and which geographies, what kind of geographical spread are we looking at by 2030 for the biosimilar business?
Hey, Nitin. It is a good question. We are right now in the early innings of launch, since a quarter, I suppose, with biosimilars, Nitin. Supplies are being initiated to certain territories in the EU. Tender is being serviced in LATAM, and the Statera agreement will start to fructify from the end of this year. Revenue recognition will follow as those products will move through distribution channels into procurement, et cetera. In terms of what we are doing, we have omalizumab and denosumab, as I have talked about in the last quarter. That will be entering the filing phase with European Medicines Agency, Health Canada, and the FDA this year. Additionally, I have also provided guidance in Q2 that we plan to file bevacizumab, which is already approved with Health Canada, approved with MHRA, and currently under review with European Medicines Agency.
We also plan to file that in the U.S. 2026 will be a year where we wanted to execute the U.S. filings, the 3 filings in the U.S., at least 2, but 3 filings in the U.S. What it does to the business if you look at 2030, is that the first wave of products that are being commercialized now, plus the 3 more products that will be approved in Europe is a clear base. You have about 7 products in Europe, emerging markets, and the growth markets. As I have provided guidance in the earnings presentation, I am also stitching partnerships in territories where we are not directly present. For all these to strategically fructify would take a year or 2.
With a 7, 8 product base model in Europe approved and in growth markets, a potential 3 products approval by 2028, 2029 or 2030, even with a slight U.S. FDA setback, if there is any. By 2030, you are looking at biosimilars business having 7 to 8 products in Europe and growth markets, plus a potentially 2 to 3 products in the U.S. I would not give any guidance, specific revenue figures at this stage, but the commercial momentum is real and is building, and I expect by 2030, with the 7 plus 3 products that I am planning in the U.S., biosimilars business will have an inflection point, as I have also guided all through in the last year and the last quarter as well. Does that answer your question?
Nitin, just to add to that, the fact that we are in the first wave of launches are coming much behind the competition. What kind of opportunity do you still see, while you've already talked about it in terms of our cost competitiveness on COGS in the business? With the dynamics over the last few year, last few quarters, are you still confident that there is still a relevant opportunity for us in emerging markets in Europe on these products?
I can't hear you. Your voice was breaking. Can you repeat your question?
Just give me one second. Sir, can you hear me now?
Yeah.
Can you hear me? Yeah.
Be a bit slow.
Yeah, yeah. Sir, I was saying, in the first wave of launches that we have, the fact that we are coming much behind the competition.
In Europe and in emerging markets, do you still see an ability for us to make reasonable revenues on these products? Is the opportunity still relevant for us in the first wave of launches?
In the first wave of launches, the opportunity is relevant to the extent the aspiration is. We are not looking at a 15%-20% market share in those territories. With the right cost of goods, we still believe there is an enough opportunity for everyone. If you look at the nature and dynamics of the biosimilars business now, even if you look at products that are going off the patent cliff in 2032, you will have about 10 to 11 players who are already doing clinical trials or developing them. If you want to sustain in this business, you need to really create a COGS model that will allow you to position yourselves in the market. What is also important is creating a basket of products in oncology and immunology.
Right now, the choice of products that we have made, I'll give you an example of pegylated filgrastim, which is a long-acting filgrastim that is expected to increase the neutrophil count in cancer patients who suffer from a condition called neutropenia. There is no follow-on drug for this product. What we are looking at from the first wave, Nitin, is products that have a longer life cycle. Pegfilgrastim, even now, is a potentially $3.54 billion market, and I expect it to continue to grow. In U.S., I think there are about 4 to 5 players there. I am sure if you're looking at $50 million-$60 million revenues or not looking at taking away 20%-25% of the market share, you are still in the game.
In that sense, it's a very calculated move from us to pick products that have a longer life cycle. The other example is trastuzumab, where we launched the 150 and 420 mg, but the real game with trastuzumab is the subcutaneous that we are developing. The patent goes off in 2028, 2029. You should look at it from a strategic perspective of how we are positioning the products that will advance our aspirations in this space. Our COGS, I think, will continue to sustain us. If you are saying, will I be picking up a 20, 25% market share? Absolutely not. That's not the aspiration at all.
Thank you, sir. That helps. Sir, secondly, sir, at what point in time do you start to be part of the first wave of launches going forward?
It's a trick question. omalizumab, I think we will be in the first wave. If you say first wave is 3 or 4 players right now with omalizumab, there are 3 serious players. Celltrion has already made the move. It's a potential $4 billion market. There are 2 other players there and then there is us. We expect bevacizumab, omalizumab to be a $2 billion-$2.2 billion product even after the biosimilar competition kicks in. I think that would be the first wave when we have the capacities to sustain the supply chain in markets like U.S. for omalizumab. With the next wave of products, we are trying to green light the clinical studies for the next wave of products that goes off patent cliff from 2030, 2031 onwards. We may be in the first wave, but first wave is becoming very subjective these days, Nitin.
If I pick a product from 2034 like atezolizumab, there are nine players who are already developing it. We really see how the dynamics play out. It's quite intuitive and subjective to answer the question, but I hope you got the clarity.
Yes
on the point that I'm trying to say.
Yeah, that is very, very helpful. If I can squeeze one last one. Sir, on CDMO, how should we think about CDMO? Our CDMO strategy is all about these two MSD projects or do you see opportunities to significantly go beyond that? At what point can that happen?
It's a good question. See, the scales at which we are attempting to become a CMO is a key differentiator in India, right? If you look at my product schedule 1, product schedule 2, and product schedule 3 that we have disclosed to the exchanges. The total drug substance manufacturing scales amount to about 120,000 liters of mammalian cell culture capacities. That's by far the largest CMO space in the country, and which will put us into the lower rank bracket of the largest CMOs in the world. For example, Lonza has about 570,000 liters. Samsung has around 600,000 liters. Having 120,000 liters is a statement and intent that we are here to stay. Why do I build a business model around one anchor customer? Because India traditionally did not have contract manufacturing organizations in the new biological space.
It requires deep competence, infrastructure building, and the nurturing of human resources capabilities like no other. That's the reason why I wanted to de-risk the ramp. By mean of de-risking the ramp, I wanted to get an anchor customer like MSD, get a contract with them for about 10 years, and see how credibly I can build the business for the next five years. To answer your question, does Theranem and does I and Aurobindo on the board want us to be a single customer CMO after 2032? No. The vision statement for 2032, which I presented to my board yesterday also, is that we wanted to be a multi-modality, multi-customer, contract development and contract manufacturing organization. Right now, we are a CMO, make no mistake about it. We are not a CDMO right now.
We wanted to be a CMO, but we wanted to backward integrate by 2032 to become a contract development organization. This is not going to be a one-customer business, but for the first five years, until I build credibility around an anchor and service the anchor and create a space that we are also a credible CMO coming out and can service the new biological entities and become part of the global supply chain, yes, we would like to stay with MSD and learn through the curve, but the long-term aspiration and ambition is to become a multi-modality, multi-customer CDMO and transition from a CMO to CDMO. Does that answer your question?
Yes, it does. Thank you so much. Thank you so much for your time.
Thank you. The next question is from Tushar Manudhane.
Sir, thanks for the opportunity. Sir, just extending on this biologics venture, at the time of commercialization, what kind of gross margins or EBITDA margins are we sort of building into our estimates? May not be at a product level, but maybe at a portfolio level, if you could share.
Tushar, is this about the biosimilars or the biologic CMO?
Biosimilars.
Biosimilars. On an average, you are looking at a gross margin of around 65%-70%, Tushar. As the product mix matures to include omalizumab and include trastuzumab subcutaneous after 2028, 2029, the gross margins will probably shift to the higher side of 70%-75%. It's still a very healthy margin business. It also depends on the countries you would be in. The moment the inflection point in U.S. and some of the growth markets will kick in, you are looking at better gross margins. Some of the products are retail products. For example, a product used in post-menopausal osteoporosis, like denosumab. Whatever little you sell there, the margins are going to be higher. It's a tricky subject, but I would say take anywhere between 65%-75%.
As we continue to evolve in the next 5-6 years, we will make the transition from around 65% to 75% with the more first wave or differentiating products or retail products adding into the business. Because omalizumab and denosumab is a retail product, omalizumab is a mixed model, so you tend to get higher margins there, Tushar.
This is after building Particularly in biosimilars, we've witnessed a sizable price erosion post competition coming in.
This kind of gross margin basis, the manufacturing skill set which we have got.
what kind of price erosion we try to build for these set of products?
Sure.
Is that so that we understand?
across such kind of price erosion, the gross margin is 65%-70%.
For the first wave of products, we have already built in the price erosion to a great extent. Even with a 75% price erosion, we expect to have around 65% gross margin as a base, and only then we enter into developing these products. In the U.S., we are not building more than a 60% price erosion. In Europe, we are building close to around 75%-85% price erosion. We have seen that happen in chronic segment in Europe. In growth markets, actually, the pricing is good in some of the growth markets. To answer your question, even after building a very healthy price erosion of around 70%-80% in most markets, this is what we would like to achieve, Tushar.
That's pretty interesting, sir. Just to sort of complete this loop, in chemical synthesis, probably the scale does help in getting the EBITDA margin. With respect to biosimilars, just trying to understand, despite such kind of price erosion, being able to achieve 65%-70% gross margin. If you could just help me with that missing link compared to, say, a chemical synthesis process.
It's a very interesting question from a sense that, in biologics, you should always look at yield versus COGS as a function of also capacities, okay? Which is true even in small molecules. In biologics, when I plot yield and capacities on the primary Y-axis and the secondary Y-axis and COGS on the horizontal axis, you see the tapering of the COGS pretty early. Depending on your capacities, if my capacities are around 5,000-liter scale and my yield is around 4 gram per liter, then the incremental improvements, even after increasing the scale, are going to be very minimal in terms of cost of goods.
Okay.
Factoring all these models, we still think if you have built your capacities right, if you have positioned your titers or the yields around 4 to 6 gram per liter, because after which the downstream costs will start to trade off any benefits that you'll get from the cell culture yields. Around 4 to 6 gram per liter and a capacity of around 2,500-5,000-liter bioreactors, you should have a cost competitiveness for most monoclonal antibodies that are at 100 mg-400 mg filling doses. I think 60%, 65% should be very straightforward in biologics, even with the price erosion of around 70% that you witness. The trick there is, do companies have the yields of around 4 to 6 gram per liter at the right quality?
Do companies have the right capacities for the products they are putting in at 4-6 gram per liter? If either of these on the primary and secondary Y-axis don't meet together, then you are looking at numbers and margins that can be significantly less because their COGS is going to be higher.
Got it. This is pretty interesting. Just lastly on this aspect, just to refresh in terms of the overall investment done till date while we have highlighted in the presentation the upcoming investment with respect to unit. If you could just refresh in terms of the overall investment done till date.
In biosimilars?
Yes.
About $450 million is the overall investment, including CapEx and OpEx, that was done in biosimilars, and that had resulted from 2018 July to now, including the 2 COVID years, into 4 European approvals, 2 healthcare approvals, and 3 more product filings now, the fastest in the peer group that you can look at. I'm confident that we will continue the momentum.
INR 150 million-INR 175 million is the over and above.
No, this is a CMO. Okay. The CMO is going to be about INR 175 million in the greenfield facility.
Got it. Thanks.
Thank you. The next question is from Kunal Dhamesha.
Thank you for the opportunity. The first one for Subbu, sir. Can you suggest what's the kind of translation effect that we get from the INR depreciation against USD and euro? Let's say 1% depreciation in INR, what's the positive impact that we get on EBITDA?
See, 1% which INR depreciation against dollar?
Yes.
On EBITDA, we'll get around INR 100 crores.
Okay. Euro, INR depreciation against Euro would be addition to that, right?
No. Yeah, Euro is very little. Okay? Already Euro has achieved the peak. Earlier it used to be around 101.03.
hovering between 1.16, 1.17, may not have a big significant one on euro.
rupee, EBITDA on dollar rupee transaction, we'll get around INR 100.
The 21% EBITDA margin guidance for FY 2027, does it bake in this positive impact of the INR depreciation?
No, because, see, nothing comes free. When rupee is depreciating, why is it depreciating? Raw material prices are going up. Solvent prices have gone by 2.5x.
only rupee depreciation going to translate. It is a combination of all things we have to see.
Fright cost actually has gone significantly high in the last month, March, and continuing in April and May. Solvent prices have gone by 2.7x.
Okay
other raw material prices are also going. You have to look at it in a holistic manner rather than seeing it in a very limited manner.
My question, I'll rephrase that with all this cost going up, it will still have a positive impact, right? Given the strong depreciation.
No, you asked what is the impact of it, we have said. Will it get offset by other factors, et cetera? Obviously, yes.
Okay. maybe, 21% bakes in the net impact of all these positives and negatives, right?
All the factors. All the pluses, minus, et cetera, we are looking.
Okay. Second question on the PenG. We said that the 10,000 ton is the output. We are going to reach that kind of level now. Within 80% capitalization, to me, a very basic math kind of points to 12,500 tons of total capacity versus our total capacity is 15,000. Is it fair to say in terms of yields, there could be some more improvement going forward?
No, not like that, Kunal. I said it is above 10,000 K. We have achieved in the month of March itself is around 1,300 tons capacity.
Okay.
Right?
we made it around 10,800. The capacity is not either 10,000 or 15,000 or not like that.
17 fermenters. We can run any number of fermenters I wanted. Accordingly, the capacity is achieved. We have to ensure that the inventory buildup is not happening, working capital is not locked in, and at the same time.
We need to achieve the right yields, et cetera. That is what the team is doing.
Mm-hmm. Sure.
You got it though?
Yes. Lastly, for Dr. Satakarni on the Theranem contracts. Can you suggest how many products have we got right now from Merck? Are these in development stage or already commercialized? If they are already commercialized, are they in the early part of their product life cycle, late part of product life cycle? Any color would be helpful.
Well, product Schedule I is for one product. Product Schedule II is for one product. In the nutshell, each product schedule is for one product.
We signed about 3 product schedules, which means that we signed for 3 products. Right now, technology transfer of 1 product, a new biological entity is happening. This is a product that is already commercial.
The second product schedule also is a commercial biological entity. One of them is an early commercial product, the other one is a relatively established product. I cannot give more details about the sponsor's products, but we will be into the commercial global supply chain right from day one after receiving the regulatory approvals. That is the business model of CuraTeQ. Right from day one, once you have the regulatory approvals, the product that we are going to manufacture at CuraTeQ is going to be used by MSD into their global supply chain for the patients in the territories, in the markets they would like to supply the product to. Does that answer your question?
Sure.
There is no development product at this stage. Both are commercial assets.
Okay. Earlier we had said that these supplies would initially be used for emerging market and then in Europe and then in U.S. Is that the correct way of understanding?
That's correct. Capability building and GMP compliance takes time. Initially, I expect MSD to file it in emerging markets, followed by Europe, and potentially at some point, maybe they would say they would also like us to become part of the supply chain for the U.S. Right now, I would keep the aspiration to emerging markets and Europe.
Thank you, and all the best.
Thank you.
Thank you. The next question is from Shyam Srinivasan.
Good morning. Thank you for taking my question. Just the first one on the specialty injectables. I think in the opening remarks you just said $513 million has been the total revenue for the year, and I think 13% growth. Is it, sir? If you could just double-click there. How should we look at the outlook for it in 2027?
Yeah, you heard it right from Subbu. Other than the lenalidomide, it is 13%, and I feel like the same double-digit growth is expected going forward.
Yugandhar, there is some Revlimid already in 2026, right? INR 513 million includes Revlimid. You're excluding it and telling us it's whatever double-digit growth.
That's right.
Sorry, can you just help us what the base number was?
No, just actually the base number would be around INR 480 plus.
Okay.
We expect the similar double-digit growth, because this year of 2027 onwards, we will not have that Revlimid.
We expect the base business to continue to grow in double digits.
Any interesting launches coming up in this segment, Yugandhar? Anything to call out?
At this juncture, it is too early for me to comment, Shyam, because of EU GSP. There are some interesting launches from other plants.
We are, at this juncture, keeping ourself on watch for all the regulatory approvals for the plants so that in next quarter I can give more color.
Got it. Helpful. Just, Swami, just quarter-over-quarter, I know year-over-year there is Revlimid in U.S. total, but quarter-over-quarter, there is some seasonality, is it, for why the quarter-over-quarter revenues are down?
Typically, the fourth quarter is less than the third quarter. Typically. The second and third quarter, this is what we see. There are aberrations, of course. If the cold season extends to January, March, it could be higher, but otherwise, second and third quarter are the best.
INR 30 million drop and all one can explain just by seasonality?
Yes, that is one, and we also have some partners. We'll also have to look at that. Broadly, yes, there is a seasonality.
Understood. Thank you. My just last question to Dr. Satakarni Makkapati. Dr. Satakarni Makkapati, now we have all your large cap peers, like large peers, all talking about biosimilar. Sun Pharma through the Organon deal has got it. Dr. Reddy's, Lupin have got it. I'm not asking for names, but I'm just saying, is this going to be an interesting phase where we have to now slug it out with some of your other peers? Is there something you will do differently to kind of get your rightful share?
It's interesting, Shyam. How can I comment on the slug fest that is going to unfold in the biosimilar space? It's already happening in Europe. To one of the previous questions from Nitin, I told the market dynamics is going to be so interesting. The price erosion is going to be so interesting. The competition, any product that you pick, there are about 10 to 11 players. What is important is to ensure that you have a basket of products that you can go to into the market, create a brand name, as long as they are continuing to be brands like in Canada and U.S., and make sure that your COGS setting is good enough to still give you a reasonable margin. I don't think I can do anything differently than what I have done.
The speed and agility with which we have looked at the last seven, eight years in building these capabilities, I would like to sustain the momentum, and if that happens, I think we are in good space. Right now, the most important aspect for CuraTeQ is the execution of the U.S. filings, and can we execute it right first time? If we do, I think we'll be having a very different conversation.
Got it, sir. Thank you and all the best.
Thank you.
Thank you. The next question is from Jigar Valia. Hi, Jigar. Requesting you to unmute yourself and ask the question.
I'm sorry. Firstly, congratulations on the decent set of numbers under these circumstances with API prices and freights. I think your own growth markets, et cetera, I think all helped API. 1 is with regards to China and India. Has China breakeven helped in margins this time? As far as India, I think is about INR 76 crore a quarter. Will this Khandelwal acquisition, how much would that contribute to the run rate?
Sir, in terms of the China, as I said, last quarter, we had a loss of around INR 7 million. Last year, I'm sorry. Last year. Certainly, this year we'll not only break even, we'll contribute significantly. At least we are working to achieve a low double-digit EBITDA margin for the year. That is what we are trying to do there. In terms of the Khandelwal Laboratories, et cetera, it's a very decent acquisition, and it is contributing to the EBITDA margin. We expect overall the entire domestic formulation business will grow in double-digit during this year.
Got it. Now only Unit 3 is amongst the larger unit which is left for the EIR, right?
Vibander?
Yeah. Unit 3, yeah, we are waiting. Even unit 1 of Eugia is also audited. We are waiting for that as well. There are 2 units. In Eugia network, we are waiting.
Helpful. Sir, just one more question if you can answer. If at all you can update on Eczema or Pomalyst, and also what's the perspective with regards to repurposed drugs. You also mentioned, Sat Karni sir mentioned of the slugfest possible on the biosimilar, is there something which is getting evolving on the repurposed drugs as well?
Sir, Sat Karni, would you like to take that question? I didn't understand.
What is the question?
One was, would it be possible for you to update on Eczema and Pomalyst, and also your thoughts with regards to repurposed drugs. You mentioned of the slugfest expected on the biosimilar, but I don't see any of the larger companies probably warming up to repurposed drugs or these things, or any of the generic companies also.
I would answer the part 2 of the question. Part 1 of the question-
Yeah
should be answered by relevant CEOs.
Yes.
What you mean by drug repurposing is whether we are interested in the practice of finding a new therapeutic use for the existing drug. Is that what you meant by drug repurposing?
Yes, I think because a lot of it.
I know what's happening around that.
Yeah.
At this point of time, I'll get back with my investor relations again, but from the little I understand from our board strategy and all, at this point of time, we are not looking at any reprofiling or repositioning or repurposing of the drugs. That's still not part of our Aurobindo board's strategic initiatives. We will look at this space closely. Maybe that's a differentiator at some point, right now not. Let me go back and correct myself if there is something happening somewhere and provide you an answer. Does that satisfy you?
Absolutely, sir.
Yeah. Thank you. Part one, can someone answer part one?
Actually, we didn't understand the part 1 question of the Pomalyst.
Is there any update on the eczema and Pomalyst that we can have it?
Sorry, Jigar, this is Ashish here.
Sir.
Is your question on the Eczema drug which was approved?
Yes.
Yeah. Thank you. We are right now looking into launching it as soon as possible. The most probably quarter two of our fiscal year is when we are aiming to launch. That's all I can say for now. All the preparation work is going on right now to make sure that we launch our first NCE for Aurobindo in a very successful manner.
Okay. All right. Thanks a lot. I'm hoping that you'll be upwards of INR 2,000 for EBITDA from becoming quote onwards and higher EBITDA levels also with the integration falling in place. Thank you. Thanks so much.
Thank you. The next question is from Tarang Agrawal.
I got a couple of questions. Good morning, congrats on a recently firm performance. In Europe, sir, you spoke about double-digit growth. Going forward, you mean constant currency or you meant in INR terms?
Constant currency basis, which I already reaffirmed. This year we achieved double-digit and also our growth planning for the upcoming year revolves around our base business growth plus new launches. Annualized revenue on the FY 2026 launches and upcoming FY 2027 launches. We are quite confident we'll be able to achieve on constant currency basis.
Okay. If I look at the trajectory of this business, right? Aurobindo's been trying to build this business for the last 12 years. Something's really sort of pivoted in the last 3, 4 years versus the decade before. In a market which is certainly not growing, especially with the sort of products that we are running with, what has changed in terms of your ability to drive this business and at the speed and scale that you've been able to? Just a couple of pointers. Is there a lot more focus than before maybe? Were there some supply chain challenges? Has the market become more interesting with some players exiting? What is it? Just wanted your aerial view in terms of, without getting into-
Sure
significant granularities. Yeah.
Sure, Tarang, I get the flavor of your question. First of all, thank you for your compliments. Yes, one, Aurobindo has been an evolving organization, so our understanding of the market and extremely well streamlined team across our footprint countries sitting in.
Understanding the market dynamics. Of course, as you rightly said, on the supply chain side, we have definitely done a lot of improvements by way of order processing, turnaround times, understanding the market, what should I say, the upsides or certain competition out of stock that can happen, and all these things. It's a combination of several items. At the same time, as you underlined, it's a very complex market. We are answerable to multiple regulators. The expectations or challenges are increasing, whether it is nitrosamine or other compliance requirements. Despite all this, Aurobindo as a team has been able to deliver. I would like to thank our management for the confidence reposed in it, and constantly providing us new product opportunities, developing more and more products.
It's a combination of all these positives that's happening, and we are very confident this will be sustainable in the coming period as well.
Wonderful. That helps. Satish sir, on Theranum, whatever progress that you spoke of when you spoke about consistent delivery for contract one in 2028 and then for contract two from 2031 onwards, were you referring to calendar year or were you referring to financial year?
I'm referring to the financial year, Tarang.
Okay, that's helpful. On U.S., on the eczema product, Ashish Anvekar, do we expect you to build a significant front end or would you be continuing with the current cohort that you have? Second, if we could get an update on what's happening with Ryzneuta. Where is that product? I think about one and a half years now since the approval's come through, so some update there would be helpful.
Sure, Tarang. First of all, for the ADQUEY, which is the brand name for our eczema drug, we are going to build the suitable infrastructure as it is required. We will be in a competitive space, but in a very good competitive space, so we have to invest in making sure that we are giving the brand the due attention, and the resources which is required. Our current presence is in oncology, right? We will be having a separate team which focuses on dermatology. For the Ryzneuta, though we had an approval for a year and a half, the product launch was delayed. Much of the scientific story is still being built. We have started getting some traction in the market now, but the story from a brand perspective still needs to be built in the marketplace.
The market is very competitive. It will take us some time for that product to be established. We just want to make sure that the product has a basis of a scientific story, which is a longer-term story, rather than a short-term pricing story.
All right. That's helpful. Swami sir, is $400 million a reasonable base for the U.S. business, notwithstanding the seasonality, going forward? X acquisitions and some of these NCs contributing.
No, I didn't understand the question. Yeah, you're saying INR 400 million is the base?
Right.
Yeah, that's correct.
Because it came down to $387 million this quarter.
Yeah.
Kind of-
Yeah. That's reasonable to assume.
Got it. Last one, Eugia, if you could give us a split for FY 2026 and 2025 between U.S. and ex-U.S.
Anyway, because we don't give separate numbers, but it still contributes around 70% of the overall business. 30% comes from other than U.S. Going forward, we expect that to be a 60/40.
Got it. The INR 513 is the overall number, right? U.S. as well as ex-U.S.
That's right.
Okay, wonderful. Thank you.
Tarang, let me correct myself. I think I talked about 2028 and 2031 in my earlier commentary and guidance for unit 1 and unit 2 of CMO. If it is 2028 and 2031, then I'm talking about calendar years and not financial year. My apologies.
Got it. Thank you.
Thank you. Requesting management for the closing remarks.
Thank you. Thank you very much, everyone, for joining us on the call today. If you have any of your questions unanswered, please feel free to get in touch with the investor relations team. The transcript of this call will also be uploaded on our website, www.aurobindo.com, in due course. Thank you once again, and have a great day ahead.
Thank you.
Thank you very much to Aurobindo's management team. Ladies and gentlemen, on behalf of Aurobindo Pharma, that concludes today's conference. Thank you for joining us. You may now disconnect your line and exit the webinar. Thank you.