Concord Biotech Limited analyst Q&A

Thank you very much. We will now begin the question -and-answer session. The first question comes from the line of Chintan Sheth from Girik Capital. Please go ahead.

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 could not 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 be spilled over into subsequent quarters, would be helpful.

So, on account of the written confirmation, the total amount was close to around INR 20 crores to INR 25 crores, which, as I mentioned that has been realized in Quarter 3, On account of the Middle East tender, that amount also stood at around INR 20 crores, for which, as I mentioned, we still do not have clarity, and there is a deferment of the tender. So, part of it has been realized in Quarter 3. The other part, we are still awaiting clarity from the government on the tender results or when it will be opened up.

And that seems the full-year guidance will continue to be healthy if we add this back up. We ar e anyways single digit or slightly lower on a Y- o-Y basis. Prima facie, the annual run rate or annual growth does not seem to be very much affected because of the weak Q2 in the first half.

No, as I mentioned, that there had been a temporary sh ift in the procurement patterns because of the U.S. tariffs, and t his has impacted the industry as a whole. So, as I mentioned, we expect to recover , deferred revenue in the coming quarters, but the exact timing and the quantum is difficult to specify at this stage. But that being said, our current visibility for H2 is strong, and we are seeing positive indicators. We anticipate delivering growth in H2 higher compared to what it was in FY '22 of second half. But the magnitude will depend on several factors. So, we are kind of working towards achieving that growth, but we will be in a better position to provide clarity only by Quarter 4.

And on the CDMO opportunity, any color on the ongoing one of the projects we won last quarter? Any color on how it is progressing? You mentioned that the final or confirmed offtake guidelines will be provided next year as the product gets launched and ramped up in the end market. But if you can , how has that been the progress, then it would be helpful.

Yes, again, there is no change there. So, 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 U.S. And we will be getting the visibility on the forecasting by, as I mentioned earlier also in our previous discussions, by the next year. So, 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 will have also put the inventory or finished products in the market in all areas.

Last, we turn to the U.S. part. I believe that last year, the full year, the contribution of the U.S. to our overall revenue was somewhere around INR 100-odd crores, which was 10%-12% of the overall revenue. Given the fact that the visibility of the tariff situation, even though the clarity has c ame through, the pattern still remains a little blurry for you to provide that at the timing of the reversal of all the shipments , which we 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?

No. As I mentioned earlier, while our direct sales to the U.S. were around 10%,, we are also supplying material to Indian companies, and they are manufacturing the finished formulation and then supply it to the U.S. market.

Those indirect sales.

Exactly. . Therefore, the impact would also have come through the indirect route, as I mentioned. However, as, our current visibility on H2 stays strong. And this deferment of revenue, we will try to mitigate to the extent possible. But the magnitude, I will be unable to kind of give through. But definitely, the H2 is going to be stronger than H2 of FY'25.

Ankur, thank you so much for the explanation. I will join back in queue for other queries.

The next question comes from the line of Hardik Doshi from White Whale Partners. Please go ahead.

Just continuing on the previous question. If you add, let's say, even INR 50 crore of revenues from these two one -offs, there is still a slight de- growth on year-on-year basis , on a decline in overall revenue. I think we get to about INR 300 crore versus INR 310 crore last year. I understand that there is this U.S. demand deferment as well that happened. Some of it would have come indirectly, as you mentioned, from the customer. Is there any way to quantify that? And the second question is, what happens to the customers in Europe who did not get the orders in time? I mean, do they kind of switch to other suppliers, and then how does this impact your long -term relationship with them?

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 the U.S., Australia, New Zealand, LatAm, and other markets. So, how much quantity of that has m oved to the U.S, as API manufacturers, we would not know but we know that we have issued them a letter of access for different markets. So, we know that their end markets are all, but what has been the split between those markets, even as API manufacturers, we would not know . So, that is to answer your first question. The second question, with respect to the EU, our EU customers were also very worried in terms of this delay of the written confirmation because some of them were at a stockout situation, or say, close to a stockout situation. And they were worried that if this thing had moved on to December, we would be somewhere getting closer to the December holidays for Europe. So, they were also worried, and there were concerns with them also. However, in the APIs, particularly in fermentation, where there are limited players, there is also a lot of stickiness. And our relationship with these customers goes much beyond 10 -15 years. So, our customers also understand that this is not something that is in the hands of Concord, but we are also relying on third parties , but they were also a bit jittery in terms of not getting the material delivered, and positively that issue is behind them, and we have not seen any concerns after that since we have informed them about the written confirmation.

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

No. We receive the approvals every three years. The last time, there was no issue as such. It is not an annual thing. But yes, I mean, for us, such a long duration was a first time.

The other question I had was that we have been talking about kind of diversifying into other areas like away from immunosuppressants and built in the other verticals. So, can you maybe give some sense or color in terms of numbers in the sense that what is the proportion last year, where is it now, and what kind of growth rate is happening in immunosuppressant versus the rest?

So, most of the development that is happening on the new product side is primarily happening in the non -immuno segment. The product like Nystatin 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 Nystatin, we continue to observe. But in this case, the quantum of API required is relatively very small. So, you may not see it in the revenue contributions, but that effect has already started taking place in Nystatin. And we are pretty confident that once the product becomes commercial with them, we will see a good market penetration of Nystatin, which is an anti -infective product. The couple of innovators that we said we are trying to work with, one of them is in the oncology segment. So, it is also in the non-immuno. As time progresses, we will see greater market penetration in the other segments. However, immunosuppressants have a much longer life cycle, and as a result, their contribution levels are higher. So, it is also, in a way, an added advantage because our innovators see that Concord has a good market share with the generics, so why not work with Concord for their supplies as well? So, it also, in a way, helps us to kind of build business with the innovators on the immunosuppressant. But the new products penetration is also happening in the non-immunosuppressant, as I mentioned.

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

So, for the six months, it is around 76%.

And let's say two to three years out, I mean, can this come down to like 50%, or it would not be at that stage?

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

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

So, it's been nine years now that we have been on the market on the finished product. We have not seen any concern on that matter.

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

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

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

Sorry, my mistake. Again, I will 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.

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

We can all represent to the government that they should move on. Actually, I will tell you that there were certain issues with respect to compliance, we did face the cough syrup issue because when we followed up with the authorities, they mentioned that around that time, the whole cough syrup issue came up , and all the authori ty people were occupied in addressing the issue. So, there was a lot of delay in terms of looking at the documentation because of this matter. So, 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.

I mean, I am 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 have got the approval and the time that they have submitted, the timelines look to be a little bit more stretched out. But my sense is it is because of the concerns that they saw from the industry on this whole cough syrup issue. That is what our understanding would be. But 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 US FDA and our EU inspection. We had made the application in June. So, the expectation was that by July, August, or so, we should get the approval. But I think it got delayed by a couple of months because of this issue.

The second question is, I mean, even if we adjust for the INR 45 crores of delayed sales, both the EU aspect as well as the Middle East contract, our first-half sales have 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 were given. Now, the base is also fairly high as far as the fourth quarter FY'26 is concerned. So , qualitatively, is it possible for you to provide any comments on the extent of growth you are expecting in the second half?

As I mentioned, we anticipate that the growth in H2 is going to be better compared to what it was in FY'25. But as I mentioned earlier, the magnitude, we do not know because we depend upon several factors. So, 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. But from where we see things right now, our H2 numbers look to be better than last year's H2. But a s I said, if what has impacted has impacted the U.S. tariff issue, if it has impacted, it has impacted others as well, particularly companie s. So, Concord would be no different there. So, t his is more of a timing thing. It is not a loss of the business opportunity. So, we will try to mitigate it to the extent possible. We have to see how much we can do this year. But that quantum, we will have to wait and see how that goes. And when it comes to the guidance, as I said, I mean, we have spoken on multiple occasions, Alank ar, that it is not guidance 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, or in terms of the new facilities that we have set up, which were not contributing earlier to the overall growth that we have historically seen. So, that's where we get the confidence of going to that number as capacities from injectable units start picking up, as CDMO starts picking up. So, I will 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 dip we have also not seen, and I am sure you people have not seen this kind of volatility in global markets because of the c onflicts, because of the uncertainties in the U.S. But many of those things are behind us. So, I think that is how we are seeing things improving, and what we have also seen the improvement in the second half of the year.

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

So, t he shift in the procureme nt patterns doesn’t really change the pricing. But our pricing, as you see, customers that we have been working with have been fairly stable. And if you see that excluding the injectables or excluding the Stellon, our EBITDA stands at 41%, which is pretty much in line with what you would have seen historically. So, pricing with the current customers would not change. But yes, of course, with certain newer customers who may be bringing in larger volumes, in case there is an expectation on better pricing, then that is something that, in the larger interest, we may look at on a case-by-case basis on what could be done, but things have been fairly stable, I would say, with the existing customer base.

And t he final bookkeeping one, Lalitji, can you share the utilization rates for the three facilities, or maybe the injectable one as well?

The injectable has just started. So, it is not much utilization as far as the capacity is concerned. But a s far as Unit -1 capacity utilization is concerned, it is around 76% for the H1. And for Valthera, it is around 24%. And for Limbasi, it is around 52%.

The next question comes from the line of Huseain Bharuchwala from Carnelian Capital. Please go ahead.

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

On the CDMO front, is what you are asking?

Yes.

So, on the CDMO front, currently, on the commercial side, we have only one project. And as I mentioned, sales of that have started, and it is progressing well. B ut b y next year only we will have more clarity in terms of how the full year looks . The rest of the projects that we have commercialized, we have a couple of which have been commercialized, but the quantum is relatively small there. And some of them are with the intent to kind of build a larger relationship with that global MNC company. So, basically, it is like making inroads into that account. So, those are smaller opportuni ties, and that is why we have not highlighted that. But t he commercial one is just one right now. We had been in discussion, as we have mentioned in earlier conversations, that we have been in discussion with two potential innovator companies, of which one was put on hold because of this whole Trump issue. So, we have again started reaching out to them now that there is clarity that they d on’t get impacted even if they look at Concord as a potential supplier for their product. So, 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. So, I think we will continue to engage with them with the hope that in the coming quarters, we should hear some positive news from them.

Further on this, I would like to know, the molecules that you are working on with them, are they early -stage molecules? If you can give some color, are they late-stage molecules? Any sense on that?

No. These are commercial molecules. They are already commercially selling these molecules in the U.S., so they are not under development, but commercial products.

That's it from my side. Thank You.

I would like to know about your inves tment in the CAR -T cell therapy. So, which stage 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 the U.S.?

So, right now, what we are doing is we are doing the development part in the CAR-T cell 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 it's a little early to kind of give it out. But 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. And then this is something that we are primarily targeting the Indian market because this would also require some clinical studies to be done. But as we work on this, this also opens up the o pportunity 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. So, the idea would be to not only cater to what we are doing in this area for the Indian market, but also to kind of cater as a potential partner when we reach out to global players in this space.

Secondly, if you can split the U .S. and ex-U.S. revenue in the export, how would that be? Lalit Sethi That could be in this quarter; it i s around 7% to the U .S., and the remaining 38 % % is to the rest of the world.

So, that is 7% of the total revenue is from the U.S., and let's say 38% is from the ex-U.S. countries of the total revenue.

Yes.

And about the injectable facility, like in the last two quarters, we have put in some costs in the injectable facility, which has turned down to our EBITDA. How long will this cost continue? Will that continue in the third quarter and fourth?

We have 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 and December, which did get in March. So, 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. So, in the India market, we have already started doing it under our own branded generics. But 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 enga ging with the companies for out licensing activities. So, 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 parties. The quantum is, again, a little early to say because what we would be focusing on is that we are a backwardly integrated com pany. So, with all quality focus right from API to the finish, because no other company than Concord makes the API and is integrated to the finish formulation, So, there is an advantage that we will be giving it to our customers. But how many customers we work with and at what time frame, that will kind of, it could be in the first quarter, it could be in the second quarter. So, it is 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 market. Now, this facility can do close to INR 400 crore s to INR 600 crores, but the potential market for the products that we are manufacturing or intend to manufacture from this site is over INR 3,000 crore s to INR 4,000 crores. So, absorbing this facility for the Indian market itself is not a problem, but we have to see which customers we kind of work with and what the quantum is that we get out of those customers.

The next question comes from the line of Aditya Pal from MSA Capital Partners. Please go ahead.

Sir, just wanted to understand from you, so in our first concall, a couple of years back, we had said that our Dholka facility has a revenue potential of INR 600 crore s, and the Limbasi facility has a revenue potential of close to INR 1,600 crores to INR 1,700 crores of revenue at, obviously, 75%-80% capacity utilization. So, I just wanted clarification, The Limbasi and Dholka facility takes into consideration that some part of the capacity will be manufactured for our Valthera units. Is my understanding correct?

Correct. That is correct. 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. Aditya Pal And also a bookkeeping question. If you can give me the capacity utilization across our four units.

As I said, the injectable is the new facility which has been commissioned in the month of March. The remaining three units, which are the Dholka facility, is operated at around 76% in H1 2025- 26. The Valthera facility, the OSD facility, has worked at around 24.31% in H1FY 2026. And the Limbasi facility has worked at 52% in H1 2026.

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

So, the products that we manufacture do not get classified under CMO. They are our products. So, they get classified under our API business. Only products where we are working with the third party's IPR and their intellectual document, I mean, their process, that is where we say it is classified under the CMO. So, our own manufactured products will be under the API category only.

But the molecules will be different, or molecules will be the same?

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

So, thank you, everyone, for joining our Q2 and H1 FY'26 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 Relations Advisors. Thank you once again. Have a good evening.

Thank you, sir. This brings the c onference 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.