Ladies and gentlemen, good day and welcome to the Gland Pharma Q3 FY25 earnings conference call. As a reminder, all participant 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 call, "please signal an operator by pressing star, then zero" on your touch-tone phone. Please note that this conference is being recorded. I now hand the conference over to Ms. Ranjini Jain. Thank you, and over to you, ma'am.
Thank you, Leo. Good evening, everyone. We welcome you to the Gland Pharma's earnings conference call for Q3 FY25. Today, we have Mr. S rinivas Sadu, Executive Chairperson, Mr. Shyamakant Giri, Chief Executive Officer, Mr. Ravi Mitra, Chief Financial Officer from India's office, and Mr. Alain, CEO of Cenexi, who's connected virtually from Caen. We'll begin the call with business highlights from Mr. Sadu, followed by Mr. Giri, who will share his vision about the company. This will be followed up by an overview of Cenexi from Mr. Alain, and lastly, the group financial overview by Mr. Ravi. Before we proceed, I would like to remind everyone that some of the statements made today will be forward-looking and are based on management's current estimates. These statements should be considered in light of the risks associated with our businesses.
The call is being recorded, and the transcript will be available on the website shortly. With that, I'll hand over the call to Mr. Sadu for his opening remarks. Over to you, sir.
Thank you, Ranjin. Good evening, everyone, and welcome to our Q3 and nine-month FY25 earnings call. I would like to start by wishing you all a very happy and fulfilling New Year, filled with new opportunities and achievements. Let's dive into our financials and operational performance. At the consolidated level, our Q3 FY25 revenue was INR 13,840 million, with consolidated EBITDA of INR 3,600 million, translating to a margin of 26%, a 100 bps increase year-on-year. Our base business, excluding Cenexi, generated INR 10,122 million in revenue for the quarter, an 8% decrease year-over-year. This was due to volume degrowth in some of our key products, partly compensated by new launches. We expect to recover these volumes in the coming quarters and remain optimistic about the overall trajectory of our business.
The EBITDA margin for our base business was a robust 39%, compared to 34% in the same period last year. The margin improved in the quarter due to changes in the product mix, and the measures carried out in reducing costs and various funds. Coming to year sales, we launched 13 new molecules during the quarter, including Clofamizine, Dexamethasone, Phenylephrine, Phytonadione, and Diphenhydramine. These launches strengthen our product portfolio and position us well for continued growth in the US market. Revenues on the rest of the world markets increased to 21% of our total revenues in Q3 FY25. The Indian market generated INR 562 million in revenue, contributing 4% to our total revenues. Let's discuss the progress of our complex product portfolio. Today, we have completed nine filings in a targeted portfolio of 19 products.
Six of these complex products have already been launched, with three more expected to secure approval in due course. These products target an IQVIA market opportunity of $7.1 billion, reflecting the significant potential of this segment to drive future growth. In addition, we are very excited to inform you that 15 complex formulations, which are under co-development with Nectar Pharmaceuticals, a specialty injectable development company, have shown promising progress. These include seven 505(b)(2) and eight ANDAs at different stages of development. We expect commercialization to begin from FY27. In nine-month FY25, we filed three RTU infusion bag products, with 10 more in the pipeline. These products are part of our RTU portfolio, with 14 bag products registered. These RTU bags have an IQVIA of about INR 530 million value in the US, and these filings show our commitment towards prioritizing newer technologies in infusion bags.
In Q3 FY25, our total R&D expenditure was INR 437 million, representing 4.3% of our base business revenue. During the quarter, we filed four ANDAs and received approval for eight, including latanoprost ophthalmic solution and phytonadione injectable emulsion. This brings our cumulative ANDA filings in the U.S. to 366, with 312 approvals and 54 pending. Globally, we now hold an impressive 1,736 product registrations, demonstrating our ongoing commitment to expanding access to high-quality medicines. On the regulatory front, we are pleased to announce that we have received EIRs from the U.S. FDA for Unit 1 and Pashamylaram facilities in Hyderabad, signifying successful closure of the last U.S. FDA inspections. We remain dedicated to upholding the highest quality standards across all our operations. Turning to biologics, we have entered a collaboration agreement with Dr. Reddy's Laboratories.
This partnership leverages our state-of-the-art biologics manufacturing facility at Genome Valley in Hyderabad and opens exciting new opportunities in a rapidly growing biologics CDMO segment. This is expected to generate incremental revenue starting next financial year. We are happy to also inform you that we have signed a CDMO collaboration non-binding term sheet with Shanghai Henlius Biotech as well. This aims to establish a secondary manufacturing site at Gland for some of the key biosimilar products of Henlius. These collaborations demonstrate our continued focus and investment in biosimilar CDMO space. Coming to Cenexi, the business recorded revenue of EUR 41 million in Q3 FY25, though below our estimates, mainly impacted due to reduced manufacturing activity following regulatory audit at Fontenay during the quarter.
However, gross margin improved to 77% compared to 75% in Q3 FY24. We have Alain on the call for a more detailed update of recent developments and key initiatives at Cenexi. Finally, I'm delighted to introduce our new CEO, Mr. Shyamakant Giri. We are confident that his extensive experience will be invaluable as he leads the company towards continued success. You will hear more about his vision and plans for the company in his address shortly. I want to reaffirm our commitment to driving long-term growth through strategic partnerships, innovation, and investment in new products and technologies. Thank you once again. I would now request Mr. Giri to take over.
Thank you, Mr. Sadu. Good evening, everyone. I'm delighted to join you all for today's earnings call, and I'm honored to address you for the first time as the Chief Executive Officer of Gland. It is both a privilege and a responsibility to step into this role, especially as the company actively pursues strategic initiatives to expand its global presence and strengthen its market position. As I begin my journey at Gland, my immediate priority is to understand the company's current operations and improve profitability while identifying new opportunities to enhance our growth, strengthen our capabilities, and expand globally in areas where we can excel. I have started collaborating with the team to evaluate our direction and strategy from the very first perspective and build a future-fit plan. I have identified key priorities both on the demand and the supply side as we develop our overall strategy.
On the demand side, we have four identified priorities. One, ROW market growth. We will improve our footprint and launch new products focusing on high-value, high-growth countries instead of having a cluster or a continent approach. Two, India domestic growth. We will leverage our portfolio strength in selected therapies and explore inorganic expansion within India. Third, U.S. market expansion. New customer acquisition and value expansion from the current partners will be crucial for our growth in the U.S. And finally, portfolio assessment. We will continue to seek strategic partnerships and pursue potential M&A opportunities to incorporate more high-value injectables and newer modalities into our commercial portfolio. On the supply side, the four identified priorities are: one, maintaining quality and cost leadership. We will strengthen our operational efficiencies to lead in both quality and cost. Two, engagement with Cenexi leadership.
We will ensure that the cost-correction measures achieve their desired profitability outcomes and provide both strategic and financial value. Third, intensifying R&D focus. We will enhance our new product pipeline and accelerate our current projects. And last but not the least, improving management bandwidth. We will hire top talent and more empowered leadership teams. All our strategies will be built on the foundation of our established core values while fostering a culture of innovation, collaboration, and excellence. I am grateful to the board and the chairman, Mr. Sadu, for entrusting me with this responsibility, and I'm excited to work closely with our leadership team. This is truly an exciting time for Gland, and I look forward to collaborating with all of you to chart the next phase of the company's growth journey. I welcome your perspectives and ideas as we embark on this collective endeavor.
Thank you again, and now I'd like to hand it over to Alain to provide an update on Cenexi's performance. Over to you, Alain.
Thank you, Mr. Giri, and good evening, everyone. Cenexi's performance for this quarter was impacted due to certain factors. At our Fontenay facility, Q3 FY25 production was impacted by an unannounced inspection by the ANSM, the French health authority. Cenexi is committed to working closely with the ANSM to address the observations raised. On a positive note, I am pleased to report that our new high-capacity ampoule line began production last week, right on schedule. This addition will increase our ampoule manufacturing capacity by 40-50 million units, allowing us to better serve our customers moving forward. In Hérouville, in France, commercial production of a new inactivated vaccine and a ophthalmic gel commenced in December, as anticipated, and will ramp up gradually in 2025. Additionally, we have begun installing a new prefilled syringe line, which is expected to be operational later in the year.
This will significantly boost our capacity to meet the growing demand for this dosage form. In Braine-l'Alleud in Belgium, orders from a new customer unfortunately had to be deferred from Q3 to Q4 FY25. As mentioned in our last call, earlier setbacks from the lyophilizer breakdown continued to affect our production levels in Q3, and we expect this to get restored in H1 of FY26. Given these developments, we anticipate a weaker performance for the January to March quarter, but I want to emphasize that all major projects remain on track and aligned with our strategic goals. We remain firmly focused on achieving our medium-term goal of delivering positive EBITDA in full year 2026. This will be driven by our efforts to push revenue beyond the EUR 200 million threshold.
With that, I want to thank you for your time, and I will now turn the call over to Ravi to discuss financial performance. Ravi, over to you.
Thank you, Alain. Good evening, everyone. We are grateful for your time and presence today. Let's take a look at our financial performance for the quarter and nine months ended 31st December 2024. I'm very pleased to inform you that our EBITDA and PAT margin improved during the quarter. The EBITDA margin increased to 26% as compared to 23% in Q3 FY24, and stood at INR 3,600 million for Q3 FY25. For the base business at Cenexi, the EBITDA margin did significant improvement for Q3 FY25 at 39% versus 34% in the same period of last year. Improvement of gross margin and better cost management has led to the improvement. We, however, reported a negative INR 312 million of EBITDA at Cenexi, primarily due to the unannounced inspection by ANSM at Fontenay site in this quarter.
The EBITDA for the nine months ended December 2024 stood at INR 9,214 million compared to INR 9,744 million for the same period of last year. We have reported the EBITDA margin for nine months FY25 at 22% at the consolidated level and 34% for the base business. The gross margin for Q3 FY25 also showed an improvement to 67% from 61% in Q3 FY24 due to change in product mix. In our base business, the gross margin was at 63% as compared to 56% in the previous year. We are happy to see a better margin profile of the new products launched during the year and this quarter. Our net profit for the third quarter increased by 7% at INR 2,047 million compared to Q3 FY24 and increased by 25% sequentially from the second quarter.
During this quarter, we achieved a PAT margin of 15% and improvement from 12% year-on-year. During the nine months of the current financial year, our PAT was INR 5,120 million at 12% margin. Revenue from operations stood at INR 13,841 million in Q3 FY25. The gap with the corresponding quarter in the previous financial year was primarily due to lower shipped volume of certain products for the US market, which we expect to complete in the next quarter. At Cenexi, production was impacted by an unannounced inspection by the ANSM, the French health authorities. Revenue of our base business at Cenexi, while it showed growth of 3% in nine months FY25, was driven by increased performance in the US market. It decreased by 8% in this quarter compared to the same period of last year to INR 10,123 million.
Revenue from operations for the nine months FY25 stood at INR 41,916 million, a year-on-year increase of 2%. Other income for Q3 FY25 was INR 585 million. This includes INR 525 million from interest on fixed deposits and INR 20 million in foreign exchange gains. For nine months FY25, other income totaled to INR 1,696 million, INR 1,548 million from interest income, and INR 65 million from foreign exchange gains. The higher finance cost during the quarter is related to the interest on a GST refund matter. The total R&D expense for the third quarter was INR 437 million compared to INR 530 million for the same period of the previous financial year and stood at 4.3% of the revenue from operations on an ex-Cenexi basis. The total R&D expense for the nine months was INR 1,419 million, which was 5% of our revenue, demonstrating our continued focus in R&D.
On a standalone basis, our effective tax rate was 25% in the third quarter and 26% for the nine months of the current financial year. As of December 31st, 2024, on a group level, we had a total of INR 27,189 million in cash and cash equivalents. After accounting for Cenexi's debt, our net cash position was INR 24,122 million. Cash flow from operations during the nine months was INR 5,889 million. Working capital stood at INR 23,060 million as of December 31, 2024. The average cash conversion cycle improved at 162 days for the nine months ended December 2024, compared to 182 days in the same period last financial year. The total CapEx spent during the quarter was INR 1,379 million at Gland's Indian sites and at Cenexi. In India, we are spending growth CapEx at expanding a new bag line and increasing the packing capacity.
We are also in the process of adding a new cartridge line at Suite 9, which will be in addition to one existing cartridge line at Pashamylaram site. At Cenexi, as Mr. Alain mentioned, we are adding some additional high-speed and new lines to improve the overall capability. With this, I request the moderator to open the lines for questions. Thank you.
Thank you very much. We will now begin the question and answer session. Anyone who wishes "to ask questions may press star and one" on their touch-tone telephone. If you wish "to remove yourself from the question queue, you may press star and two". Participants are requested to use handsets while asking questions. Ladies and gentlemen, we will wait for a moment while the question queue assembles. "To ask questions, please press star and one". The first question is from Neha Manpuria from Bank of America. Please go ahead. Ms. Neha, we can't hear you. If you're on a headphone, we request you to use the handset.
Hello. Hello.
Can't hear you, Neha. We can't hear you.
Ms. Manpuria, I request you to maybe call us back, maybe from a different number. Your voice is extremely unclear. We'll move to the next question. The next question is from Bino Pathiparampil from Elara Capital. Please go ahead.
Hi, Giri. My first question is on the U.S. business. We have seen a QOQ decline in the run rate and YOY as well. So you mentioned that there were some volume declines in the quarter. Could you comment on what is it, quarterly phenomenon, some stock adjustment, etc., and what is that going forward on the quarterly run rate?
So Bino, we had certain products which were not shipped out, some of the main products like Enoxa, and we plan that to ship back in the next coming quarter. Some of our products so demand side, we don't have any issues here in terms of the forecast, what we receive from our customers. It is just the shipping timing thing which instead of Q3, we'll be probably planning for next quarter.
So next quarter, we should see a significant QOQ improvement in numbers. Can we assume so?
Yeah. So next quarter, this will be compensated by some of the products which I mentioned, which would happen next quarter.
Understood. And this quarter, the margin at Cenexi has come in strong. So despite the top line being low, what has led to that?
So gross margin, you mean, or EBITDA margin?
Both, I think.
Both. Okay. Yeah, so gross m argin, I think, improved by a couple of percent, and that is largely a factor of the product mix at different sites, and some of the products, as you know, are high margin like vial and lyophilized products compared to the ampoules, and on the EBITDA side, also the cost side, we have kind of controlled, and that has slowed down the benefit of EBITDA as well.
Okay. Sorry, if I can ask one more question on Cenexi. So the earlier guidance was a positive EBITDA in fourth year of this year. So in the opening remarks, I heard that you have changed it to a positive EBITDA in FY26. But in FY26, if you could let us understand how the trajectory would be. So initial couple of quarters, the losses will continue, and then it will pick up. Is that how we should think about it?
We are estimating now third quarter FY26 could be a bit of a positive quarter. One is we mentioned about the inspection that happened last quarter. So we lost a few weeks because of that. So that's kind of impacting the next quarter numbers a bit and last quarter numbers a bit. So that's the main reason. So we're estimating, I think, it will move a few quarters, two quarters.
Okay. Thanks. I'll turn back to you.
Thank you. Participants who wish to ask questions, "please press star and one". Next question is from Neha Manpuria from Bank of America. Please go ahead.
Hi. Thanks for taking my question. Am I audible now?
Yes. Go ahead .
Okay. Sorry about the TV sound. Just following up on Cenexi, I understand that there was an inspection, but is there more to the inspection which is leading us to delay the break-even to third quarter? I mean, have the authorities highlighted something to us which needs us to shut down production for long? I just wanted to get a sense as to why 10 days of auditors delaying the break-even by three quarters?
So one is, of course, the lost time. It took almost, I think, three weeks' inspection. There are two inspections that happened. So we lost production during that time. And there are corrective measures which we need to take. So some observations which we need to work on. So that will take some loss of production time. That's why we're estimating now it could be the third quarter.
Understood. Okay. Understood. And my second question is on the ROW business and the Saudi contract. Have we made any progress on that? We were expecting some shipments by the end of the quarter or in the fourth quarter. Is that still on track or any status update on that?
Yeah. I think that's one of the reasons we actually missed the revenue estimate this quarter. So it got pushed out a bit, and it didn't get dispatched. And also, it kind of impacted positively in the margin profile because it's a low-margin business. But on the revenue side, we lost that. I think it got pushed out by a quarter.
Should that come through in the fourth quarter, or is there more delay expected on the Saudi tender?
We actually got the tender. It's just allotment of the hospitals that got delayed, so it could be this quarter or the first quarter of next year.
Sorry, this quarter or? I didn't quite catch that.
Or the subsequent quarter.
Oh, okay. Okay. Got it. And my last question is on the Biologic Bit. I think you mentioned one, the Dr. Reddy's supply would start from April 2026. And there was also a second CDMO agreement that you mentioned. I didn't quite catch that. With whom that was, and when should we expect that to start contributing?
This is an agreement with Shanghai Henlius. It's a Chinese company which has launched biosimilars in different parts of the world, including the U.S. We have signed a term sheet as a second site for their 500 products. [crosstalk] That will take probably two to seven, maybe two years from now.
Oh, two years from now.
Once it's transferred, yeah. Once the agreement is firmed up, then it will take a tech transfer, and it will take time for that.
Okay.
Yeah. Yeah.
Okay, so this is probably April 28 onwards?
Yeah. Sure. 27, 28, I would say. Yeah.
Okay. Got it. Thank you so much.
Thank you. To ask questions, "please press star and one. Next question is from Vivek Agarwal from Citigroup. Please go ahead.
Yeah. Thanks for the opportunity. Just one question from my side. It is good to see that India and ROW, particularly the non-US markets, are seeing the kind of attention now that has been required. So if you can just elaborate basically how we are going to do that, what have we been lacking so far, what new basically we are going to do in these markets? Thank you.
So India, Vivek, we want to leverage our portfolio strength. We are already having a cost leadership position because of the CDMO activities. And India as a market is also growing. We are integrating to launch some therapies in India. And of course, we are getting various therapies as we speak. We are also evaluating any inorganic route to expand our presence in India. This is something that we're doing on the India side. On the ROW side, we are now changing our approach. Earlier, we used to see ROW from a continent lens like Latin or Africa or Gulf. We have moved that lens to now focus on top countries, five, six top countries like Saudi, Mexico, South Africa, and so on, where we will really want to be aggressive in terms of partnership and filings and all of that.
We are now divided the ROW into three groups. One which is high value, high pharmaceutical value. And second is, of course, medium and so on and so forth. This approach, I think, will help us resource these markets well and put a new acceleration plan in place in ROW.
Thank you. Thank you. That's from my side.
Thank you. To ask questions, please press star and one. Next question is from Aman Goyal from Axis Securities. Please go ahead.
Yeah. Good evening. So my question is related to the Cenexi. So in the last quarterly phone call, you had said then Q4, the Cenexi will be break-even at EBITDA level. So can you throw some light? So any estimated time that we will see the break-even for Cenexi business?
Aman, like, we just mentioned that we expect now to EBITDA break-even at Q3, FY26 next year. [crosstalk] This is largely a factor of how we can push the top line to a 15 million per quarter run rate and then keep the cost under control. That can be achieved by new high-speed lines. One of the additional lines is already up and running in Fontenay, as Alain mentioned in his speech. In addition to that, there are also a couple of activities which are going on at HSC and Belgium side, which will improve the output significantly without having more cost at manpower and other overheads. This will be happening at Q3 level because Q2 is anyway a summer shutdown, and we want to also utilize like last year to build up all those new additional capabilities we are putting in.
So Q3, we estimate that would be a time that we expect the top line to touch 15 million or more and then have EBITDA break-even.
So my last question is, in the last earnings call, we talked about the GLP-1 contract on the CDMO side. So we have three customers, different customers on GLP. Could you throw some light on that, the size or revenue to be started in the commercialization, something like that?
So basically, it's two customers and three products contracts [crosstalk] to be clear. And revenues, you know the patent landscape, right? And it depends on which markets and all that. So we can't really give the numbers to it. But probably we'll start seeing some numbers on FY26.
Okay. Thank you, sir.
Thank you. Participants who wish "to ask a question may press star and one". Next question is from Harsh Bhatia from Bandhan Mutual Fund. Please go ahead.
Yeah. Thank you. I'm audible?
Yes.
Yeah. Thank you. So just on this biologics versus biosimilar contracts for ready, I think the last quarter you had mentioned this is a non-exclusive contract, and you have a certain capacity, mammalian drug substance capacity. So not only that, that was a biologics CDMO, biologics versus biosimilars contract. The nature of the contract with the Chinese company is also very similar in terms of the contract commitment, the volumes of the size of the contract, or is it materially different?
I think materially this could be different because there's a, of course, the contract still needs to be signed off. It's a term sheet design, but it's a whole pipeline of biosimilar products, what they have already commercialized and also what is there in the pipeline which will go up within the next few years, and it could be a second site, so we're already looking at expansion of the drug substance side to increase the capacity to 15 KL to meet the demand, so it could be substantially different compared to what we have done earlier.
So you already have an 8 KL capacity, and this could in the foreseeable future go to 15 KL capacity?
Right. Additional 15 KL capacity. An additional 15 KL capacity.
Yeah.
Okay. And where are we in terms of, let's say, for the Cenexi customers, those customers who are looking to get into the US market and other ROW markets? Our plan was to sort of get them to shift their capacity commitments to the Indian manufacturing facilities. So where are we on that part?
Aman, Harsh, can you repeat your question, please?
In terms of the Cenexi contracts and the customers, your aim was to sort of move their ROW capacity from the Cenexi sites in Europe to the India sites over a period of time. Where are we on that as of now?
We are having currently some visits by customers, and it's too early to comment at this point of time. We are seeing interest from their customers, and the work is going on.
So they must have already visited your India facilities, right?
Yeah. Yeah. Somehow.
Okay. Just one last very quick one. Again, in terms of Heparin and Aspirin, again, at a macro level, China does control a lot of capacity in terms of the raw materials as such. So anything incrementally that you could think could be a second-order derivative for the tariffs from that angle?
I think it's more to do with the direct imports into the U.S., not to the materials what we buy from China. So I don't think there's a real impact on that.
Do Chinese players, again, just very broadly, does China or Chinese players directly supply these raw materials into the U.S. market as of now?
So from a positive side, the companies who are actually competing with us directly in China, now they might be affected if this 10% thing gets implemented and on the pharmaceutical products is still not very clear. Then the people who are competing with us in Heparin and some of these products from China will be more competitive against them in terms of certain products. So that will be an advantage for us in terms of finished products. And probably APS also. But I would say local manufacturing in China, in the US anyway, is not that competitive. But I would say the Chinese players who are directly exporting finished products to China, if this 10% tariff comes on to those products, then we'll be more competitive with them for sure.
Just very lastly, if there are, let's say, next to 100% in terms of the RM component for Enoxaparin Heparin, how much of that would be China-based captive consumption, and how much would be going outside of China, very roughly put, if you would have the numbers?
You mean within the U.S.?
No. China production getting consumed within China and as compared to going out of China getting exported?
I'm not sure on the exact quantity, but I think globally, they control about 45-50% of Heparin APIs production. A bit more also in 60%.
Okay. 50 to 60%.
Yeah.
But how much is consumed within China and outside the country?
Okay. Sure. Thank you. Thank you.
Thank you. Next question is from Shyam Srinivasan from Goldman Sachs. Please go ahead.
Yeah. Hi. Good evening. Thank you for the question. Just the first one on the U.S.ness. We had 13 launches during the quarter. And despite that, we've had a QOQ even in the base business, excluding Cenexi in the U.S., we have seen decline. Could you just explain, is it price erosion that it seems to be higher?
No. I think the major drop is Enoxa, which we expected to supply to Saudi didn't happen. That's a major loss. And the launches that happened, compared to that, the volume is lower, I would say. From margin profile, the product we launched in the last two, three quarters is better margin products. And that's why you're seeing an improvement in margin profile across products.
Sorry, but I'm looking at just the US market. I'm assuming Saudi Arabia would come in ROW, right? Sorry. I'm getting confused.
US market QOQ decline. Even U.S. regarding the supply of Enoxa, I think there's a decline of, I would say, I'll give you a percentage also but 12% down in terms of quantity variance for Enoxa and Ketorolac, the other two products, and that's the reason, the primary reason why w e lost that decrease in the volume.
Understood. So we should expect Q4 that there'll be a recovery there or we'll start shipping Enoxa and the other product again in Q4, right?
At least U.S. Enoxa, yes.
Yeah. Yeah. I'm only focusing on the U.S. market.
Correct. Correct. From price variance perspective, from quarter on quarter, it's about, I think, 2%, 1%-2% lower.
Understood. Understood. And in terms of pricing or any of the other on the base business, excluding NX and other, has there been erosion?
No. No. There's not much price erosion.
Understood. My second question is on the 39% core margin. So if you could help us, what was the profit share and the milestones in that number?
Yes. So for this quarter, profit share is 11.7% and milestone is 10.2%.
So about 20%, I'm just adding those two numbers, is coming from these two, right?
Yeah. So profit share is a part of the product only, right? It's m argin of the product, so.
I'm not even, not. I'm not questioning the numbers. It's just that, no, I'm just trying to look at these numbers with 11 to get for us, typically, right?
Yeah. Typically about 20% together. Yeah. So some quarter it may be high, some quarter low. So if you say nine-month basis, it's again 10.1% and 8.8%.
Okay. So overall, yeah.
Some [crosstalk] dividends also, but together it's about 19%.
19%. Okay. And we should assume that you also get at least these kind of milestones and similar kind of profit share.
So basically, it's a simple math. The low-margin products, if you ship Enoxa or ki nd of a product.
It's down.
It comes down. It's like 5%-7% margin. So then the margin will get diluted about 36%.
Understood. Understood. Okay. Thank you. Thank you, sir. Thank you. Yeah.
Thank you. To ask a question, please press star and one. Next question is from Ritesh Rathore from Nippon India Mutual Fund. Please go ahead.
Yes. Hi. I hope I'm audible.
Yes. Go ahead.
How many Chinese players are active in the U.S. injectable market? Or put it other way around, how many of the front-end companies source their raw materials, source their finished injectable products from Chinese manufacturing plant? If you can give some kind of this is in context with the tariff thing which we spoke earlier.
Directly present is probably one or two injectables who are selling directly front-end. But people sourcing injectable finished products from China could be maybe four to five.
When we see our top 10 or top 25 products, such kind of Chinese sourcing or Chinese competitors, would they have a decent volume market share? With this tariff, things can swing in coming quarters. Is there a probable scenario?
At least some products, especially Heparin Enoxa, the front-end player is backward integrated 100% into Heparin. And the margin is low. Those kind of products, it will fill the balance.
In the past, we spoke about particularly new launches. We saw excessive competition from Chinese players spoiling the market. You think in your pipeline products, that kind of competition would now be much lower than what earlier you have seen for the new launches?
It all depends on the products. Because some products, if the margin profile is high, then probably it's lesser impact. But wherever the margin is lower, then that's a better impact. And there, they'll stay away from launching, I would say.
Okay. Okay. Yeah. That's it from my side.
Thank you. Before we take the next question, a reminder to participants that you may press star and one to ask questions. Next question is from Roshan Chutkey from ICICI Prudential Mutual Fund. Please go ahead.
Thanks for taking my question. I just wanted to understand going forward, if Enoxa volumes were to go higher, right, because of Chinese competition easing a bit because of tariffs. And two, particularly in this quarter, I guess you have some slippage coming from the previous quarter. So should one think that volume growth would be very high or margins will take a knock? How should one think about this?
Yeah. If Enoxa volume goes up, then overall margin will, as a percentage, come down. But in absolute terms, of course, it will grow.
US data, go to the past period, I guess.
Yeah. Roshan, there's one more data point that I would like to bring in here. So this year, if you see our new launches in the U.S., we have launched 27 molecules and 39 FPUs. Of which 30 FPUs are first-time launches in the U.S. And the gross margin there is upwards of 65% or so. So if you see, what we're doing also is extending our new launches, which are primarily complex generics, RTUs, and all of that, and being very aggressive to push that agenda, push that sales in the U.S. so that we still hold on to our gross margin in spite of Enoxa going out. And we have seen this year, for example, in quarter three, 5% of our revenue total was primarily coming from new launches that we did in the U.S. at a higher gross margin.
So while Enoxa goes up, but we also have a plan here to improve or maintain and improve our gross margin by having a good portfolio and aggressively launching new players in the U.S. market.
Understood. With respect to the Cenexi business, last we spoke, you mentioned RFQs are coming quick and fast. Can you just talk a little bit about that?
Alain, can you take that? The question of RFPs, we have a pipeline of RFPs which are addressing. So the question is around that.
Yeah. So we have a constant flow of opportunities that we are looking at. What is especially encouraging in the last quarter is that we finalized the validation batches for two products that will move in Q1 into commercial production. Understood. Thank you so much. All the very best.
Thank you.
Thank you. "To ask questions, please press star and one". Next question is from Dinesh Shah from RSPN Ventures. Please go ahead.
Yeah. Hello. So thanks for the opportunity. So my first question was when we talked about that we have margin improvements in this quarter due to the product mix and core business. So I think you did mention, I just want to reconfirm that. Is it because of the new product launches that we do, we have a better margin in that? And because of that, our product because of that, our overall EBITDA margins of the core business have been shifted up in this quarter. Is that the correct understanding?
Yes. That is definitely correct, and also the product mix we spoke about, so both of that is responsible for this higher margin.
Okay. So if I have to predict for the future, then we do expect that whatever we had in past, like 33%-34% of EBITDA margins, we do expect a better margin in the future, right?
Yeah. Yeah.
So my second question is, as we had an unannounced inspection in one of the front-end sites, so can we talk about the observations of that inspection?
Yeah. So we do got some observations in that inspection. And we want to finalize the CAPA and submit to them. So we'll let you know once the CAPA submission happens and outcome of that.
Okay. Okay. Fair enough. And my last question would be, is there any one-off in the finance cost in this quarter? We have a significant jump in this quarter. So is there any one-off?
Yeah. As of now, it is one right now. For 18 crores is on account of just on a GST refund matter.
Okay. Okay. Understood. So that's it from my side. Thanks a lot.
Yeah. Thanks.
Thank you. To ask questions, please press star and one. Next question is from Tushar Manudane from Motilal Oswal Financial Services. Go ahead.
Thanks for the opportunity. Sir, just on this, at least as far as Enoxa, H eparin products are concerned, if you could share what is our market share for U.S. market in particular?
I think Enoxa is about 6%. We sell about 16 million, 16 to 18 million units. That's about 6%. And Heparin, it's around 20%-25%.
6% and 25%, right?
Yeah. Yeah.
How much would be the market share of the Chinese competitors?
They'll have a higher probability in, I think, Heparin will be in 40%, I would say. But Enoxa, I got to see.
Sorry, sir. How much? Enoxa, how much?
Enoxa, I can't tell. But still, I think 30-35 should be there. But I can come back to you, Tushar. I can take it offline.
So just lastly on this, is there any way to, I mean, practically, ultimately, the source of raw material is still the pig slaughterhouses, which are abundant in China. So eventually, one will have to depend on Chinese raw material supply. That can be changed as far as supply of ultimate formulation function. Is that right?
Yes. So the basic source is still China. Otherwise, if you go to US source, it's more expensive. But within China, we have several crude of Heparin sources so that we could be more competitive in terms of pricing. We get some volume disclosure and all that. So it's a continuous work what we do in terms of processing of the crude to Heparin and Heparin to Enoxa, if you can say both molecules. But still, we have to depend on the API.
Thanks. Thanks.
Thank you. To ask questions, please press star and one. The next question is from Harsh Bhatia from Bandhan Mutual Fund. Please go ahead.
Yeah. Thank you for the follow-up. So just in terms of, again, Cenexi part, you've spoken a bit about these capacity expansions and certain capabilities across ampoules and PFS and inactivating vaccines as such. Any of this or anything other than this relates to, in any point, towards the site manufacturing capacities, directly or indirectly, to that extent? I mean, it would be too early to comment on that.
Can I repeat that? It sounds very clear, the question.
Sure.
You're saying can we use Cenexi's capacities for Gland's use? That's what you're saying?
No. Cenexi's capacities for customers who are looking for GLP-1 manufacturing capabilities to that extent because you're.
Yeah.
Yeah. So it's part of the plan. I mean, part of the CapEx plan we're evaluating because there's a big opportunity out there for that, CDMO for that also. So it's under evaluation to install capacity for that. While even the syringe line, what we are installing now this year, that also has a capability to fill cartridges. So it has a capability. But the plan is future CapEx, we're evaluating whether you want to invest into additional CapEx on the bulk cartridges, which is more economical compared to the sterile cartridges, which can be done on the current syringe line
. Yeah. But opportunity is there, yes.
Could you just sort of help us understand what would be the cartridge capacity, let's say, at the Cenexi level, if possible, the bulk cartridge capacity?
I mean, if you utilize the complete 100% of the syringe line, what we're just installing for cartridges, it can produce about 40-50 million cartridges.
40-50 million cartridges. Okay. Okay.
Yeah.
Okay. And what would the order book look like? I think so in the first quarter of this financial year, it was somewhere around EUR 20 million , if I'm not wrong. What would the order book look like right now for Cenexi?
Sorry, I couldn't understand. What is regarding fourth quarter, you mentioned?
Yeah. For the third quarter, what would the order book look like, the order book for third quarter for Cenexi?
Alain, what's the order book for the fourth quarter?
I cannot answer this question off my mind, but it must be above 60 million because we have a backlog that has been carried on from 2024.
Yeah. So the order book is at the 60 million now. Yeah. Ok ay. Thank you. Thank you.
Thank you.
Keeping in mind that we have usually a three-month confirmed order horizon with our customers.
Thank you. The next question is from Vivek Agarwal from Citigroup. Please go ahead.
Yeah. Thanks for the follow-up. So this is related to CapEx as well as investment. So the next three years, how much the company is going to spend on biosimilar plus GLP-1 put together?
In the CapEx?
Yes.
So, biosimilar, we are currently evaluating for the 15KL capacity. We estimate should be around $80 million-$200 million. But currently, it's a process of calculating a projected valuation. GLP-1, we've already invested into it. The line will be installed this year, next two quarters. So there's no additional investment into GLP-1 in terms of finished product. But we are looking at now that the current manufacturing side also kind of maxed out in terms of capacity, we're looking at a greenfield project for the next phase of growth.
Just a basic question. I'm just trying to understand, right? In terms of fill finish as well as cartridges are concerned on GLP-1, right? So let's say if you want to put a capacity of 100 million cartridges, right? So how long it can take and what kind of investments that may require? Just, I think, a rough answer would be very simple.
Around, I think, INR 200 crores.
How long it can require? Basically, how long you can complete the project if you start it today?
18 months. 18 months.
18 months. Thanks. Thanks. That's from my side.
Thank you. The next question is from Dheeresh Pathak from WhiteOak Capital. Please go ahead.
Yeah. Thank you. I'm sorry if you already answered this, but do you have capacity and capability for pen assembly in your current manufacturing setup? Pen or auto- injector?
Yeah. We do. We do. Yeah. We already filed products from the side.
What is the current capacity, sir, on the pen side, pen assembly side?
About 40 million.
40 million. Do you also make auto- injectors?
Yeah.
What is that capacity?
No, it's a similar common line, no? So auto injectors, basically, it's assembly. You do it in syringes, and then you assemble into auto injector.
Okay. Are you expanding this capacity, or is this the capacity as of now? Is there a plan to expand this capacity?
Yeah. So one more line we're adding this year. So it will add another INR 100 million to it.
Another INR 100 million? How much are you spending on that?
CapEx will be another. Yeah. So we already spent it, actually, most of it. This will come in the Suite 9, the additional one.
When does it get commercial?
28.
28. Like with month-wise, if you can tell me, calendar 2028? First half, second half?
Smaller volumes will come from FY 2026. The patents are expiring from ROW market and also Canadian market. But the majority will come from end of FY 2027.
End of FY20 27. Sorry, how much have you spent on this 100 million line?
See, we can't specifically tell this because part of the main site. It's one of the suites of what we have. But if we are specific for the line, we can give a number. Offline, we can take it.
All right.
But it's not a dedicated site. You don't need a dedicated site for this.
Okay. Understood. Thank you, sir.
Thank you very much. Due to time constraints, we'll take that as the last question. I would now like to hand the conference over to Ms. Ranjini Jain for closing comments.
Thank you, everyone, for joining us today. We appreciate your participation in the questions during the call. If you have any follow-up questions for this, please feel free to reach out to us. Looking forward to interacting with you in the next. Thank you.
Thank you very much. On behalf of Gland Pharma Limited, that concludes this conference.