Concord Biotech Ltd.

Concord Biotech Ltd.

1,228.85
INR
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Nov 18Next Earn

Q2 FY2026 · Earnings Call TranscriptNovember 14, 2025

Operator

Ladies and gentlemen, you have been connected to the Concord Biotech Limited conference call. Please stay connected, the conference will begin shortly.

Ladies and gentlemen, good day, and welcome to the Concord Biotech Limited Q2 FY26 Earnings Conference Call, hosted by Ambit Capital. As a reminder, all participants' lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes.

Should you need assistance during the conference call, please signal an operator by pressing star, then zero on your touch-tone phone. Please note that this conference is being recorded.

This conference call may contain forward-looking statements about the company, which are based on the beliefs, opinions, and expectations of the company as on date of this call. These statements do not guarantee the future performance of the company, and it may involve risks and uncertainties that are difficult to predict.

I now hand the conference over to Mr. Pranav Chawla.

Thank you, and over to you, sir.

Moderator

Welcome to the Q2 and 1H FY26 earnings conference call of Concord Biotech Limited. We thank the management of Concord for providing us the opportunity to host this earnings call.

From the company today, we have Mr. Sudhir Vaid, Chairman and Managing Director; Mr.

Ankur Vaid, Joint Managing Director and CEO; Mr. Lalit Sethi, CFO; and Mr.

Prakash Agnani, AVP, Accounts and Finance. I would now invite Mr.

Sudhir Vaid, Chairman, Managing Director of Concord Biotech Limited to give his opening remarks. Over to you, sir.

Sudhir Vaid

Good afternoon, everyone, and thank you for joining us on our Q2 and H1 FY26 earnings conference call. Revenue for Q2 FY26 stood at Rs 247 crores, while H1 FY26 revenues were Rs 451 crore.

The subdued performance is primarily due to delay in written confirmation from CDSCO, deferment of government tender for Middle East region, and shift in procurement patterns from US customers on the back of tariff uncertainties. We have experienced the cycle and uncertainties in the past and emerged stronger.

We believe that this is just a timing difference and postponement of sales and not loss of business. Based on early discussions and forecasts, we anticipate a stronger performance in H2.

On the EBITDA front, the decline was primarily due to the commercialization of our new injectable facility at Valthera, which had a temporary impact on margins. Excluding these initial startup costs, our EBITDA margin stood at 41%.

As the facility ramps up and achieves higher utilization levels, we expect it to start contributing positively to our overall margins in the coming quarters. Despite the challenges, I am pleased to share that the last six months have been quite eventful on the regulatory front.

We hosted multiple site inspections across our facilities. Unit 2 went through its emerging market inspections.

Unit 3, our largest fermentation facility, successfully completed its first EU inspection. We also had successful inspections at Unit 1, Dholka from key global regulatory agencies such as USFDA and EU authorities.

These successful outcomes give us the confidence and the credentials to enter new markets and secure regular supplies. In addition to the strong regulatory progress over the last six months, we also successfully executed several key strategic initiatives.

Notably, we received USFDA approval to market teriflunomide tablets, making another important addition to our portfolio. We also incorporated Stallen Biotech Inc., which will drive the marketing, distribution, and commercialization of Concord Biotech products in the US market.

Stallen will manage end-to-end commercial operations while ensuring full regulatory compliance, establishing our direct commercial footprint in the US and advancing our goal of expanding market access and unlocking greater value across key global markets. We incorporated Concord Lifescan Limited as a wholly owned subsidiary to strengthen our domestic marketing, sales, and distribution capabilities.

This move will enable us to sharpen our market focus, deepen customer engagement, and enhance our brand presence in India. We have also invested in Cellimune Biotech Limited, which is working on new ways to treat cancer using the body's own immune system.

Cellimune is developing advanced therapies like CAR-T cells, which are specially designed to find and destroy cancer cells. Its goal is to move beyond traditional chemotherapy and offer smarter, more personalized options for treatment.

Speaking about our CDMO opportunities, we remain actively engaged with clients and remain optimistic on finalizing some of the opportunities in the near term. With our strong product portfolio, requisite regulatory approvals, marquee clientele base, and diversified business opportunities, we remain confident on our long-term strategies to grow.

With this, I hand over the call to Mr. Ankur Vaid, Joint Managing Director and CEO of Concord Biotech Limited.

Thank you.

Ankur Vaid

Thank you, sir. Good afternoon, ladies and gentlemen.

We have reported revenue of Rs 247 crores in Q2 FY26, a growth of 21% compared to last quarter. However, on a year-on-year basis, there has been a dip of 20%.

For H1, our revenue stood at 451 crores. The subdued revenue performance has been on account of three major reasons impacting the overall growth.

First being the renewal application for written confirmation from CDSCO, New Delhi, a prerequisite for selling products in the European Union. Although the application was submitted in July, processing delays impacted our EU sales, as shipments could not be dispatched without this approval.

We received the written confirmation on 4th November, and it is now visible on their website also. Shipments that were on hold have now resumed and contributed to revenues in the current quarter.

In summary, this is not a business loss. This is just a timing difference where we were not able to sell in Q2, but in Q3.

The second issue relates to a government supply contract in Middle East that was being executed through an Indian entity. This contract has been deferred due to regional uncertainties and ongoing conflict.

We remain optimistic that the contract will resume soon, allowing us to recover the associated revenue going forward. Lastly, we experienced a temporary shift in the procurement patterns, particularly from US customers, driven by the ongoing tariff situation.

However, following the clarification in September that these tariffs do not apply to generic drugs, order inflows have now returned to normal levels. Additionally, progress on the second source opportunity had also been slowed due to this uncertainty, but with the tariff clarity, clients have begun responding more quickly.

This positive development positions us to accelerate our second source engagements with multiple customers and capture a larger share of the market. Overall, these are largely timing-related factors rather than structural ones, and we will try to mitigate the impact in H2 for the shift in the business.

Having said that, we remain confident about the underlying demand and the strength of our products, which will enable us to capture a larger market share. If we exclude these timing-related issues and the temporary shift in the business, the underlying unit economics remain strong.

The deferral of revenues to the following period affected overall margins due to de-operating leverage. However, excluding this impact, both gross margins and EBITDA have remained stable to improving.

Additionally, if we adjust for the expenses for our injectable facility, where revenues will accrue in the upcoming period, our EBITDA margin stands at a solid 41%. With higher revenues expected from the injectables facility and the recovery of the deferred revenues in the second half, we are well positioned to sustain and further strengthen our margins going forward.

Now let me speak about few positive developments. Over the past six months, we have secured multiple regulatory approvals across our sites, strengthening business continuity and enhancing global market access.

Our Dholka facility has received USFDA, EU GMP, and Russia GMP certifications, while our Valthera facility obtained NAFDAC approval from the Nigerian authority for the oral solid dosage facility. Additionally, our Limbasi facility has been granted EU GMP certification.

These approvals will help us broaden our customer base across regions and ensure consistent supply. We are also in advanced discussion with innovator companies for generic API supplies and are witnessing strong positive traction on this front.

Furthermore, we have been actively pursuing qualification initiatives for second source opportunities, which are now progressing at an accelerated pace. Once we achieve second source qualification, it will only be a matter of time before we expand our wallet share and potentially transition into a primary supplier over the long term.

Speaking about our newly commissioned injectable facility, we are witnessing a strong rise in inquiries and revenue traction. Our products have been successfully validated, and customer acceptance continues to grow.

With the increasing interest and improving revenue run rate, we anticipate stronger visibility and sustained growth from this segment going forward. Alongside injectables, our CDMO business continues to progress well and represents a significant long-term growth driver with a large addressable opportunity.

We possess both the capability and the capacity to serve this market effectively. We remain actively engaged with clients and remain optimistic on finalizing some of the opportunities in the near term.

Over the years, we have been successfully positioned as a leading supplier of fermentation-based APIs, creating a distinct niche within this space. Our business is built on deep expertise in complex fermentation processes, operational excellence, product development, and R&D capabilities, all of which have enabled us to create strong entry barriers and establish a sustainable competitive advantage.

With a diversified portfolio across therapeutic areas, scaled-up manufacturing facilities, flexible plant configuration, robust regulatory approvals, and an impeccable compliance record supported by backward integration, we have emerged as a trusted partner for our global customers. With this, I hand over the call to Lalit Sethi, our Chief Financial Officer, for financial and operational performance.

Thank you.

Lalit Sethi

Thank you, sir. Let me take you through the financials and operational performance for the quarter.

On the revenue front, our revenues for quarter two of financial year '26 stood at Rs 247 crores as compared to Rs 310 crores in the same period last year, a degrowth of 20%. However, on quarter-on-quarter basis, revenues have grown by 21%.

Our revenue for H1 financial year '26 stood at Rs 451 crores as compared to 526 crores in the H1 of last financial year. Revenue from API business stood at Rs 345 crores in H1 of this financial year against 401 crore during the same period last year.

Revenue from formulation business in H1 of this year stood at Rs 106 crores as compared to 125 crore in the same period last year. Revenue from domestic business stood at Rs 247 crore in this H1, and from exports stood at Rs 204 crores.

Speaking on EBITDA, EBITDA for this quarter stood at Rs 88 crores, and for H1 financial year '26, it is stood at Rs 150 crores compared to 218 crores. EBITDA grew by 44% on a Q-on-Q basis.

EBITDA margin stood at 36%, but if we negate the impact of the expenses of injectable facility, the comparable EBITDA stood at 41%. On the profit after tax, profit after tax stood at Rs 63 crores for quarter two of financial year 2025-'26, and for H1 '26, it is stood at Rs 107 crores with a PAT margin of 24%.

With this, I shall now leave the floor open for question and answer.

Operator

Thank you very much. We will now begin the question-and-answer session.

Anyone who wishes to ask a question may press star and one on their touch-tone telephone. If you wish to withdraw yourself from the question queue, you may press star and two.

Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles.

The first question comes from the line of Chintan Sheth from Girik Capital. Please go ahead.

Hi.

Chintan Sheth

Thank you for taking my questions. On the results front, if you can quantify the revenue loss for the EU part, just to help us how much of growth we have anticipated which we couldn't execute because of the challenges we faced during the quarter.

If you can just quantify, if those challenges were not in place, how much revenue growth or how much revenue can get spilled over in the subsequent quarters would be helpful.

Ankur Vaid

Sure. On account of the written confirmation, the total amount was close to around 20 to 25 crores, which as I mentioned that has been realized in quarter three.

On account of the Middle East tender, that amount also stood at around 20 crores where, as I mentioned, that still we do not have clarity and there is a deferment of the tender. Part of it has been realized in quarter three, the other part, we are still awaiting clarity from the government on the tender results or when it will be opened up.

Chintan Sheth

Right. That seems the full-year guidance will continue to be healthy if we add this back up.

We are anyways single-digit or slightly lower on a Y-o-Y basis, but prima facie, the annual run rate or annual growth doesn't seem to be very much affected because of the weak Q2 and the first half.

Ankur Vaid

No, as I mentioned that, there had been a temporary shift in the procurement patterns because of the US customer US tariffs. This has impacted the the the industry as a whole.

As I mentioned that we expect to recover this deferred revenue in the coming quarters, but the exact timing and the quantum is difficult to specify at this stage. That being said, our current visibility for H2 is is strong, and we are seeing positive indicators.

We anticipate delivering growth in H2 higher compared to what it was in FY22 of second half. The magnitude will depend on several factors.

We are kind of working towards achieving that growth, but we'll be in a better position to provide clarity only by quarter

Chintan Sheth

four. Got it.

On the CDMO opportunity, any color on one of the projects we won last quarter? Any color on how it is progressing?

You mentioned that the confirmed offtake guidelines will be provided next year as the product gets launched and ramped up in the end market. If you can how that has been the progress and would be helpful.

Ankur Vaid

Again, there is no change there. We continue to supply them quantities.

They are also in the process of increasing their field force to cater to this new product that they have launched in the US. We will be getting the visibility on the forecasting by, as I mentioned earlier also in our previous discussions, by the next year.

We have executed orders. We continue to have orders in place that we will be executing, but our customer will be able to provide a much better visibility by the beginning of next year because by then they would have the field force and they would have also put the finished products in the market in all areas.

Chintan Sheth

Right. The last bit on the US part, I believe last year full year, the contribution of US to our overall revenue was somewhere around 100-odd crores, 10% of the overall 10-12% of the overall revenue.

Given the fact that the visibility because of the tariff situation, even though the clarity has came through, the pattern still remains a little blurred for you to provide the timing of the reversal of all the shipments which couldn't deliver this quarter. Do you feel that that portion of the business will face some degrowth this year or how should we look at it?

Ankur Vaid

No, so as I mentioned earlier also that while our direct sales to the US was around 10%, but we are also supplying material to Indian companies, and they are manufacturing the finished formulation and then supplying to the US market.

Chintan Sheth

So, Both indirect will also have...

Ankur Vaid

Exactly. The impact would also have come through the indirect route as I mentioned.

As I have mentioned that our current visibility on H2 stays strong, and this deferment of revenue we will try to mitigate to the extent possible, but the magnitude at this point of time I'll be unable to kind of give through. Definitely the H2 is going to be stronger than H2 of '25.

Chintan Sheth

Got it, Ankur. Thank you so much for the explanation.

I'll join back in queue for other questions. Thank you.

Ankur Vaid

Thank you.

Operator

Thank you. The next question comes from the line of Hardik Doshi from Whitewhale Partners.

Please go ahead.

Hardik Doshi

Hi. Just continuing on the previous question, if you add let's say even 50 crore of revenues from these two one-off, there is still a slight degrowth on a year-on-year basis for the overall revenues.

I think it will get to about 300 crore versus 310 crore last year. Now I understand that there is this US demand deferment as well that happened.

Some of it would have come indirectly as you mentioned from the customers. Is there any way to quantify that?

The second question is, what happens to the customers in Europe who did not get the orders in time? Do they kind of switch to other suppliers, and then how does this impact your long-term relationship with them?

Ankur Vaid

Sure. It is difficult to quantify because when we supply the API to our domestic formulation customers, they make the formulations and cater to global markets such as US, Australia, New Zealand, LATAM, and other markets.

How much quantity of that has moved to the US, as API manufacturers, we would not know of. We know that we have issued them the letter of access for different markets.

That we know that their end markets are which all, but what has been the split between those markets, even as API manufacturers, we would not know of. That is to answer your first question.

The second question with respect to the EU customers also were very worried in terms of this delay of the written confirmation because some of them were close to stock-out situation. They were worried that if this thing would have moved on to December, we would be somewhere getting closer to the December holidays for Europe.

They were also worried, and there were concerns with them also. In the APIs, and particularly in the fermentation where there are limited players, there is also a lot of stickiness.

Our relationship with these customers go much beyond 10 to 15 years. Our customers also understand that this is not something that is in the hands of Concord, but we are also relying on third party.

They were also a bit jittery in terms of them not able to get the material delivered. Positively, that thing is behind them, and we have not seen any concerns after that once we inform them about the written approval.

Hardik Doshi

Okay. Has this issue happened with CDSCO in the past as well or this is the first time?

Ankur Vaid

No, see, we get the approvals once every three years. The last time there was no issue as such.

It's not an annual thing, but, yeah, for us, such a long duration was first time.

Hardik Doshi

Got it. The other question I had was, we've been talking about kind of diversifying into other areas away from immunosuppressants and build in the other verticals.

Can you maybe give some strength or color in terms of numbers in the sense that what was the proportion last year, where is it now, and what kind of growth rate is happening in immuno versus the rest?

Ankur Vaid

Most of the development that is happening on the new product side is primarily happening in the non-immuno segment. The product like mupirocin that we launched in February, March and where we have said that we are seeing a lot of second source conversions also happening, that second source conversion in mupirocin, we continue to observe.

In this case, the quantum of API required is relatively very small. You may not see it in the revenue contributions, but that effect has already started taking place in mupirocin, and we're pretty confident that once the product becomes commercial with them, we will see a good market penetration on mupirocin, which is an anti-infective product.

The couple of innovators that we said that we are trying to work with, one of them is in the oncology segment. There also it is in the non-immuno.

As time progresses and we will see greater market penetrations in the other segments. It is just that immunosuppressant has seen a much longer life cycle, and because of which the contribution levels are higher.

It is also in a way an added advantage because our innovators see as Concord that you have a good market share with the generics, why not work with Concord for their supplies as well? It also in a way helps us to kind of build business with the innovators on the immunosuppressant.

New products penetration is also happening in the non-immunosuppressants as I mentioned.

Hardik Doshi

What is the current, what percentage of revenues coming from immunosuppressants currently?

Ankur Vaid

For the six months, it'll be 76%.

Hardik Doshi

Okay. Let's say 2 to 3 years out, can this come down to 50% or it would not be that steep?

Sudhir Vaid

No, no. It won't dip that much because, as I said, newer products will take time to kind of build up, but we anticipate to bring it below 70%.

Hardik Doshi

Got it. Got it.

Just one last question, we're obviously expanding our formulation business. Just from a customer perspective, I just want to understand, does that create any conflict because we're going to the market and kind of competing with them in certain products?

Ankur Vaid

It's been 9 years now that we've been on the market on finished. We've not seen any concern on that matter.

Hardik Doshi

Okay. Great.

Thanks so much.

Ankur Vaid

Thank you.

Operator

Thank you. A reminder to all the participants that you may press star and one to ask a question.

The next question comes from the line of Alankar Garude from Kotak Institutional Equities. Please go ahead.

Alankar Garude

Hi. Good afternoon, everyone.

Sir, firstly, the delay in EU as well as Middle East, was it for API or formulations or both?

Ankur Vaid

APIs. Then

Alankar Garude

what is the reason for the sharp drop in formulation sales on a year-on-year basis?

Ankur Vaid

Sorry, my mistake. Again, I stand corrected.

The written confirmation is on the API, and the Middle East one is on the formulations, which is through an Indian entity that we have supplied to. I stand corrected there.

Alankar Garude

Okay. Got it.

Ankur, this CDSCO deferral, it seems a bit uncommon. You explained the issue, but what can we do to avoid such issues in the future?

We all can represent to the government that they should move [laughter]

Ankur Vaid

Actually, I'll tell you the reason was that there were certain issues with respect to compliances, we did face that cough syrup issue. Because when we followed up with the authorities, they mentioned that around that time, this whole cough syrup issue came up, and all the authority people were very occupied with addressing that issue.

There was a lot of delay in terms of looking at the documentation because of this matter. I think this delay probably is to our understanding because of that.

Of course, we don't know the real reasons for that, but what we believe is that it is because of this.

Alankar Garude

Other companies... Sorry.

Carry on, sir.

Ankur Vaid

Yeah. I'm sure other companies would have also faced similar issues.

Because when you go online and you see, we do see that between the time that they've got the approval and the time that they've submitted, that the timelines looks to be a little bit more stretched out. My sense is it is because of the concerns that they saw from the industry on this whole cough syrup issue.

That's what our understanding would be. If you see that this was a renewal, the previous confirmation was getting expired in July, and we had made the application in June after our USFDA and our EU inspection.

We have made the application in June. Expectation was that by July, August or so, we should get the approval.

I think it got delayed by a couple months because of this issue.

Alankar Garude

Understood. The second question is, even if we adjust for the 45 crores of delayed sales, both the EU aspect as well as the Middle East contract, our first-half sales has still declined by 5-6% on a year-on-year basis.

You spoke about YoY growth in the second half, and we have that 25% long-term guidance also which we are given. Now, the base also is fairly high as far as fourth quarter FY26 is concerned.

Qualitatively, is it possible for you to provide any comments on the extent of growth you are expecting in the second half? No, so

Ankur Vaid

as I mentioned that we anticipate that the growth in H2 is going to be better compared to what it was in FY25. As I mentioned earlier, that the magnitude we do not know, because it'll depend upon several factors.

While we have more visibility on Q3, we know what potentially could come in Q4, but that clarity we could be in a better position only in Q4 that we could give. From where we see things right now, our H2 numbers looks to be better than last year's H2.

As I said that if what has impacted has impacted the US tariff issue, if it has impacted, it has impacted others as well, particularly companies. Concord would be no different there.

This is more of a timing thing. It's not a loss of the business opportunity.

We will try to mitigate it to the extent possible. We have to see that how much we can in this year.

That quantum we'll have to wait and see how that goes. When it comes to the guidance, as I said, we have spoken at multiple occasions, Alankar, that it is not a guidance.

It is basically Concord has all the right ingredients in place to achieve a 25% CAGR, whether it is in terms of the facility, in terms of the product mix, in terms of the new facilities that we have set up which was not contributing earlier to the overall growth that we have historically seen. That's where we get the confidence of going to that number, as capacities from injectable unit starts picking up, as CDMO starts picking up.

I'll reiterate that we have all the things in place to go to that. Now, there can be dips like these.

This is definitely an unusual, different, we have also not seen and I'm sure you people have not seen this kind of volatility in global markets because of the conflicts, because of the uncertainties in the US. Many of those things are behind us.

I think that's how we're seeing things improving and what we have also seen that improvement in the second half of the year.

Alankar Garude

Fair enough, Ankur. The next one is, can you comment on the pricing of your immunosuppressant portfolio in particular, especially in context of these challenges around the shift in procurement patterns you mentioned earlier?

Ankur Vaid

No, shift in the procurement patterns don't really change the pricing. Our pricing, as you see, customers that we've been working with have been fairly stable.

If you see that, excluding the injectables or excluding the Stallen injectables component, our EBITDA stands at 41%, which is pretty much in line with what you would have seen historically. Pricing with the current customers would not change.

Of course, with certain newer customers who may be bringing in larger volumes, in case there is a expectation on a better pricing, then that's something that in the larger interest, we may look on a case-to-case basis on what could be done. Things have been fairly stable, I would say, with the existing customer base.

Alankar Garude

Okay. The final bookkeeping one, Lalit-ji, can you share the utilization rates for the three facilities or maybe the injectable one as well?

Ankur Vaid

Injectable has just started, it's not much utilization as far as the capacity is concerned. As far as Unit 1 capacity utilization is concerned, it's around 76% for the H1.

For Valthera, it's around 24%, and for Limbasi, it's around 52%.

Alankar Garude

Understood. That's it from my side.

Thank you.

Ankur Vaid

Thank you.

Operator

Thank you. The next question comes from the line of Hussain Bharuchwala from Carnelian Capital.

Please go ahead.

Huseain Bharuchwala

Am I audible?

Ankur Vaid

Yes. Sir,

Huseain Bharuchwala

I just wanted to understand, I think we have earlier bagged some contracts on the CDMO part with some of our customers. I think we had done few dispatches on that front.

Any color on that? Basically, how are things shaping up with those customers?

Are there further opportunities that are opening up which can build in future revenues for us in the CDMO side? Because we are in discussion for the second supplier, but the earlier dispatches, on those clients, can there be a meaningful sustainable revenue that can be built?

Ankur Vaid

On the CDMO front is what you're asking?

Huseain Bharuchwala

Yeah. No,

Ankur Vaid

on the CDMO front, currently on the commercial side, we have only one project. As I mentioned that sales of that have started, and it's progressing well.

By next year is only when we will have more clarity in terms of how the full year looks like. The rest of the projects that we have commercialized, we have couple of those which have commercialized, but the quantum is relatively small there.

Some of them are with the intent to kind of build a larger relationship with that global MNC company. Basically it's like making inroads into that account.

Those are smaller opportunities, and that's why we've not kind of highlighted that. The commercial one is just one right now.

We had been in discussion, as was mentioned in earlier conversations, that we have been in discussion with two potential innovator companies, of which one was put on kind of an hold because of this whole Trump issue. We have again started reaching out to them now that there is clarity that they don't get impacted even if they look at Concord as a potential supplier for their product.

Hopefully we could get some visibility in the coming few quarters in terms of once their confidence level also builds up that if they do take that step, they won't have any impact. I think we'll continue to engage with them and with the hope that in the coming quarters, we should hear some positive news from them.

Sir, and

Huseain Bharuchwala

further on this, would like to know, are the molecules that we're working on with them, are they early-stage molecules? If you can give some color on, are they late-stage molecules,

Ankur Vaid

in

Huseain Bharuchwala

any sense, sir?

Ankur Vaid

No, these are commercial molecules. They are already commercially selling these molecules in the US.

They're not under development, but commercial products.

Huseain Bharuchwala

Got it. Got it.

That's it from my side. Thank you.

Operator

Thank you. The next question comes from the line of Kartik from Bajaj Life.

Please go ahead.

Kartik Kankaria

Thank you for the opportunity to ask. I would like to know about your investment in the CAR-T cell therapy.

Which phase is it, how much time would it take to commercialize, and what will be the scope of it? Will that be only restricted to India or also in the other geographies like US?

Ankur Vaid

Right now what we're doing is we're doing the development part in the CAR-T cells therapy. Basically, once we have the prototype ready, we will be targeting multiple indications.

I wouldn't name the indications that we will be targeting at this stage, because while we do know what we want to, but a little early to kind of give it out. Right now the development work is happening.

We expect that for the next 12 to 15 months, we will be focused on the development aspect of it. Then this is something that we are primarily targeting the India market because this would also require some clinical studies to be done.

This, as we work on this, this also opens up the opportunity to kind of work with global players or to kind of showcase the capabilities that Concord would develop in these coming 6 to 12 months in this space. The idea would be to not only cater through what we're doing in this area for the India markets, but also to kind of cater as a potential partner when we reach out to global players in this space.

Kartik Kankaria

Thank you. Secondly, if you can split the US and ex-US revenue in the export, how that would be?

Ankur Vaid

That could be, in this quarter, it's around 7% to the US and remaining out of 45 is to the rest of the world. This is direct US, as I mentioned.

It's direct, yeah.

Kartik Kankaria

Okay. Okay.

That's 7% of US revenue of the like 7% of the total revenue is from the US, and that's say 38 is from the ex-US of the total revenue.

Ankur Vaid

Yes.

Kartik Kankaria

Okay. About the injectable facility, in the last two quarters, we have put in some cost in the injectable facility which had turned down the EBITDA.

How long will this cost continue? Will that continue in the third quarter and fourth?

Ankur Vaid

No, we've been informing our investors on this matter for quite some time that there is this facility which will be getting commercialized. It was to get commercialized in November, December, which did get in March.

It does take some amount of time for it to start generating levels for break-evens. Now, for the initial year, we had mentioned that this is going to be primarily targeting the India market, and after 12 to 18 months, we will start seeing revenues coming from the emerging markets.

In the India market, we have already started doing it under our own branded generics. As informed in our earlier calls as well, that once we have the WHO GMP, which we expect that by January or February we will have it, after that, we will start engaging with companies for out-licensing activities.

In the next year, we expect the India business to fully pick up by our own branded generic sales as well as manufacturing for third party. The quantum is again a little early to say, because what we would be focusing on is that we are a backwardly integrated company, with all quality focus right from API to the finish.

Because no other company than Concord makes the API and is integrated to the finished formulation other than Concord. There is an advantage that we will be giving it to our customers.

How many customers we work with and at what timeframe, that will kind of it could be in the first quarter, it could be in the second quarter. It's a little early to say, but the approach is what we can talk about is that the next year is going to be about India and after that, it is going to be the emerging markets.

Now this facility can do close to 400 to 600 crores, but the potential market for the products that we are manufacturing or intend to manufacture from this site is over 3,000, 4,000 crores. Absorbing this facility for the India market itself is not a problem, but we have to see that which customers we kind of work with and what's the quantum that we get out of those customers.

Kartik Kankaria

Okay. Thank you very much.

Thanks a lot.

Operator

Thank you. The next question comes from the line of Adityapal from MSA Capital Partners.

Please go ahead.

Adityapal Jaggi

Hello, am I audible?

Ankur Vaid

Yes.

Adityapal Jaggi

Yes. Thank you so much for the opportunity.

Sir, just wanted to understand from you, in our first con-call couple of years back, we had said that our Dholka facility has a revenue potential of 600 crores and the Limbasi facility has a revenue potential of close to 1,600 to 1,700 crores of revenue at, obviously, 75-80% capacity utilization. Just wanted a clarification.

The Limbasi and Dholka facility, this takes into consideration that some part of the capacity will be manufactured for our Valthera units? Is my understanding correct?

Ankur Vaid

Correct. That's correct.

Yes. Not only for Valthera, but also for Dholka, because it can also be manufacturing certain raw materials, certain intermediates which may be, say, now we may be using it from the Limbasi facility while this facility kind of caters to other products.

Adityapal Jaggi

Understood. Understood.

Sir, and also a bookkeeping question, if you can give me capacity utilization across our four units?

Ankur Vaid

As I said that injectable is the new facility which has been commissioned in the month of March. Remaining three units, which is Dholka facility, it's operated at around 76% in H1 2026.

The Valthera facility, OSD facility, it has worked at around 24.31% in H1 2026. The Limbasi facility has worked at 52% in H1 2026.

Adityapal Jaggi

Understood. Sir, now that we are targeting CMO opportunities for larger international manufacturers, wanted to understand from you that the products that we will manufacture for them, the generic APIs part, it will be more our own existing catalog products or will it be more that non-catalog products because we have a fermentation manufacturing excellence?

No,

Ankur Vaid

the products that we manufacture do not get classified under CMO. They are our products, they get classified under our API business.

Only products where we are working with the third party's IPR and their process, that's where we say it classified under the CMO. Our own manufactured products will be under the API category only.

Adityapal Jaggi

The molecules will be different or molecules will be the same?

Ankur Vaid

No, the molecules will be different because say if I'm supplying an API to an innovator, it gets classified in the API sales, not in the CMO sales.

Adityapal Jaggi

Understood. That's about it.

Wishing you all the very best, and thank you so much for taking my questions.

Ankur Vaid

Thank you.

Operator

Thank you. We take that as the last question for today's conference call, and I would now like to hand the conference over to management for closing comments.

Chintan Sheth

Thank you everyone for joining on our Q2 and H1 FY26 earnings call. We hope we have been able to address all your queries.

For any further information, please get in touch with us or SGA, our investor relation advisors. Thank you once again.

Have a good evening.

Operator

Thank you, sir. This brings the conference call to an end.

On behalf of Ambit Capital Private Limited, we thank you all for joining us, and you may now disconnect your lines. Thank you.