Please note that this conference is being recorded. I now hand the conference over to Ankit from Gland. Thank you, and over to you, Ankit.
Thank you, Sagar. Good evening, everyone, and we welcome you to Gland Pharma earnings conference call for Q1 FY 2025. My name is Ankit, and I head Investments, M&A, and Corporate Strategy at Gland. Joining me today on the call are Mr. Srinivas Sadu, our Executive Chairman and CEO, Mr. Alain, the CEO of Cenexi, our European CDMO business, and Mr. Ravi Mitra, our CFO. Together today, we'll discuss our business performance and address any questions that you may have. We'll begin with the business highlights from Mr. Sadu, followed by an overview of Cenexi's performance from Alain, and lastly, the group's financial review by Ravi. Before we proceed, I'd like to remind everyone that some of the statements made today will be forward-looking and will be based on our current estimates. These statements should be considered in light of the risks that are associated with our business.
The call is being recorded, and a playback and transcript will be available in due course on our website. With that, I hand over the call to Mr. Sadu for his opening remarks. Thank you, and over to you, Mr. Sadu.
Thank you, Ankit. Good evening, everyone, and welcome to Gland Pharma's Q1 FY 2025 earnings conference call. I'm happy to report that we have had a good start to the fiscal year, meeting our expectations and aligned with what we had indicated in our base business and Cenexi. On a consolidated basis, we achieved INR 14,070 million in quarterly revenue, reflecting a 16% year-on-year growth. This performance aligns with our outlook and is fueled by healthy results in our core markets, along with incremental revenue from Cenexi. Our base business, excluding Cenexi, achieved INR 10,134 million in revenue, a 14% increase compared to the same period last year. While gross margins remained relatively stable, base business EBITDA margins were at 29%, compared to 30% in Q1 FY 2024.
Our consolidated EBITDA margins for the quarter were 19%, impacted mainly by Cenexi, which despite showing improvement this quarter, is still on the path to profitability. Shifting our focus to geographical performance, our core markets achieved a 25% revenue growth in Q1 FY 2025 and now constitute 76% of our total revenues. The U.S. market continued its strong performance with a 27% increase in revenues, primarily due to a healthy volume share of existing products and new launches like Eribulin, Plerixafor, Nelarabine, and Edaravone. Despite year-on-year stability, the U.S. market remains crowded, requiring manufacturers to maintain continued focus on cost competitiveness. The rest of the world business markets contributed 20% of our revenue in Q1 FY 2025, a 3% decrease compared to Q1 FY 2024.
This performance reflects the inherent fluctuations in the business, as some planned procurement and partners have been delayed to subsequent months. However, the rest of the world markets are expected to grow at a healthy rate on an annual basis. The Indian market made up 4% of our revenue in Q1 FY 2025, experiencing a 19% decrease compared to Q1 FY 2024. This performance was by design, and we are currently evaluating various strategic options to determine the best path forward for this business. Moving to R&D, our total expenditure in Q1 FY 2025 was INR 489 million, representing 5% of our base business. We filed eight ANDAs during the quarter and received approval for seven ANDAs.
And of June 30th, 2024, Gland and its partners have filed 356 ANDAs in the United States, with 295 approved and 61 pending approvals. Currently, the company holds 1,708 product registrations worldwide. During the quarter, the U.S. FDA made two surprise inspections of our manufacturing sites in Hyderabad. The inspections concluded with two and three Form 483 observations at Dundigal and Pashamylaram, respectively. As previously communicated, these observations are procedural and do not affect our compliance status. While the generic business is progressing as planned, our biologics CDMO business is also experiencing positive momentum. Our biologics facility in Genome Valley is attracting advanced stage interest from multiple players for contract manufacturing of monoclonal antibodies and novel plasma-based proteins. In addition, we are in discussions with a leading biologics company for a potential strategic collaboration.
This collaboration could involve large-scale contract manufacturing of our four biosimilars with a possible in-licensing opportunity for Gland Pharma in specific markets of interest. Although this discussion is in early stages, it represents promising avenues for Gland Pharma to maximize value in both CDMO and complex portfolio expansion. We'll continue to update you on our progress. Now, turning our attention to Cenexi, the business recorded INR 3,883 million, which is EUR 43 million, in revenue this quarter, with a gross contribution of 78% and a negative EBITDA of INR 286 million, which is EUR 3 million. We are pleased with the progress made and the positive impact of our cost control and efficiency efforts. While we remain optimistic about the opportunity, I must inform all of you that Cenexi is still a few quarters away from a complete turnaround.
Alain is here and with us today to provide a detailed overview of Cenexi's performance. Before passing the call to Alain, I want to reiterate that Gland has had a positive beginning to the year and is on track to achieve its targeted performance amidst expanding business opportunities. We are optimistic about even stronger results in the coming quarters. Thank you, and over to you, Alain.
... Thank you, Sadu. Good evening, everyone. Cenexi's performance demonstrated an upward trend this quarter. While revenues increased, we also successfully reduced losses through improved operating cost leverage and continued efforts in managing costs and efficiencies. Our Fontenay manufacturing site near Paris, a significant contributor to overall revenue, has shown continuous improvement in operational performance. We are now realizing the benefits of actions initiated earlier this year, including operational efficiency enhancements, additional weekend shifts, organizational changes, optimized production planning, and maintenance reorganization. As a result, this quarter, the site shipped higher volumes while simultaneously reducing backlog. The Fontenay site derives the majority of its revenue from ampoule fill and finish operations, and we are currently adding a new ampoule line. This line will be commissioned during the summer shutdown period of August, with commercial production slated to begin in early 2025.
We anticipate that this new line will significantly increase capacity, improve customer service, and generate approximately EUR 10 million in revenue in 2025. Our site in Hérouville, in Normandy, is poised for future growth, with significant new business expected from ongoing technology transfer projects. I am pleased to report that these programs are progressing well, and our new aseptic gel line will begin commercial production for a key customer before the end of the year. Our operations in Belgium and in Osny in France remained on track, and we are fully committed to delivering on our business plans for the year as expected. We are also gaining good traction from partners in new areas outside of small molecules, such as biologics, plasma fraction, and several difficult-to-make technologies.
While we are making good progress and our course correction plan is gaining momentum, I must also share a few important updates that may impact our performance in the next quarter. First, the July to September quarter will be impacted by August's typically lower activity levels due to the European holiday season and planned summer maintenance shutdowns at our plants. Notably, our Fontenay plant will have an extended shutdown of three weeks to accommodate the installation and connection of the new ampoule line. Second, based on the latest forecast, we reaffirm the outlook communicated during the last investor's call. A positive EBITDA for Q4 of this fiscal year and a positive EBITDA for the next fiscal year, driven by increased revenue exceeding the EUR 200 million threshold. Thank you. I will now turn the call over to Ravi to discuss financial performance. Ravi, please proceed.
Thank you, Alain. Good evening, everyone, and thank you for joining us for our first quarter earnings call. I hope you have had the opportunity to review our financial results and investor materials disclosed to the stock exchanges. Let me share the performance highlights for the first quarter. Our consolidated revenue from operations reached INR 14,070 million in Q1 FY 2025. However, Cenexi revenue in Q1 FY 2025-
Sorry to interrupt, sir. We have lost your audio. Hello?
Yeah, can you hear?
Yes, we can hear you now, sir.
However, Cenexi revenue in Q1 FY 2025 is not comparable with Q1 FY 2024 due to acquisition of Cenexi, consummated in the end of April 2024. The revenue grew by 16% compared to the same quarter last year. This growth was primarily attributed to the base business, excluding Cenexi, which grew at 14%, led by increase in volumes of existing and new launches in U.S. market. Other income for Q1 FY 2025 reached INR 514 million, primarily comprising interest on fixed deposits. This is an increase compared to Q1 FY 2024, where other income was INR 375 million, largely due to increase in interest on fixed deposits. Our gross margin for Q1 FY 2025 was 60% compared to 63% in Q1 FY 2024, impacted by the product mix at the base business for us.
However, Cenexi's gross margin improved to its historical level of 78%. In Q1 FY 2025, we achieved an EBITDA of INR 2,664 million, an 11% decrease compared to INR 2,982 million in Q1 FY 2024. This decrease was largely due to the consolidation of Cenexi's negative EBITDA during this quarter. Our EBITDA margin for Q1 FY 2025 stood at 19%, down from 25% in Q1 FY 2024. Our base business, excluding Cenexi, EBITDA margin remained stable at 29% in Q1 FY 2025. With proactive measures taken at Cenexi, we expect our consolidated margins to improve as Cenexi's turnaround progresses. Our net profit for the first quarter was INR 1,438 million, a 26% decrease compared to INR 1,941 million in the same period last year.
This decrease was primarily due to the impact of Cenexi. However, the PAT of our base business grew by 20%. The consolidated tax margin for the quarter was 10%, and the effective tax rate for the base business was 25%. Total R&D expense for Q1 FY 2025 amounted to INR 489 million, an increase from INR 457 million in the same period of the previous fiscal year. This represents 5% of our revenue from operations excluding Cenexi. As of June 30th, 2024, our total cash and equivalents on a group level stood at INR 30,488 million, and including the outstanding loans on Cenexi books, our net cash position was at INR 27,430 million.
We generated INR 4,277 million in cash flow from operations during the three months ending June 30th, 2024, compared to INR 629 million as of June 30th, 2023, due to improvement in cash conversion cycle. The average cash conversion cycle increased, reaching 148 days for Q1 FY 2025 compared to 233 days in the previous year due to reduction of inventory. We invested INR 637 million in capital expenditure during the current fiscal year, largely allocated towards upgrading and maintaining CapEx of Cenexi business. With that, I will now turn the call over to the moderator to open the floor for questions and answers. Thank you.
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 touchtone phone. If you wish to remove 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. Our first question is from the line of Saion Mukherjee from Nomura. Please go ahead.
Yes, I had. Thanks for taking my question. So just one question on the U.S. business. There seems to be some slowdown or drop in the U.S. revenues, ex, ex Cenexi, quarter-on-quarter. So can you just explain the dynamics there and how should we think about in the subsequent quarters?
I think the major difference is, I would say on the milestone receipts large. Last quarter, we had licensed some complex products which gave a larger revenue. So I would say the decline of U.S., about 13% from previous quarter, 8% is attributable to that. And if you see the quantity-wise, it's 2% lower. And also I would say it's a product which we launched, I think back in one of the GPOs, which is a low value, I would say, high volume. And because of the launch quantities, we had to supply large more quantities, which substituted the other products. So that kind of small impact, but it will normalize over a period of time.
So we still continue to, over the, I think, over the next few quarters, it's normalized numbers. So it's, I would say it's more a positive impact.
Okay. My second question is on, you know, your comment on the domestic business, your plans around that, and also acquisitions. If you can throw some light on what are you thinking on both these fronts?
So, yeah, hi, Saion, this is Ankit. So on the domestic business, we, as you would understand, most of our facilities are designed to supply for the global market and predominantly U.S. When we supply in India, we use the same facility, and somehow it compromises our overall economics on the business. We don't intend to scale that up unless we have found a solution to have a facility which is more dedicated for the India business. So I think that addresses that point. On the acquisitions, I think there are two areas wherein we are largely focused. One is to look at opportunities on the complex injectable side, which, which is more to do with the high R&D focus, focused investments. And the second part, which we are very keenly evaluating, is building capabilities also on the manufacturing side.
Today, most of our capacities and capabilities are on the small molecule side, but even there, we feel that we have the ability to further go up and see if we can do more of difficult-to-make products. So this is the large near-term focus. Obviously, on the long term, we'll have to think through if we need more organic capacity to cater to our current growth, which is coming from U.S. and ROW markets. But in the short term, these are the two focus areas for investments.
Right. Thanks. And, you know, just one last question, if I can. Of the 61 ANDAs which are pending, is there a split available between Gland's own ANDA and partner ANDA?
I can give you a number, exact number, but most of it will be Gland ANDAs, because lately everything is filed by Gland.
Okay. Okay, sir. Thank you.
Thank you.
Thank you. The next question is from the line of Neha Manpuria from Bank of America. Please go ahead.
Thank you so much. So, you know, given that Fosun sold a fairly large stake, you know, in Gland this quarter, you know, what is the thought process in terms of holding in the company? Have you had any conversations with Fosun?
Neha, for some reason, we couldn't hear your question well. Is it possible for you to say it like... I don't know if it is to do with speaker or something. The voice was not clear.
Ankit, sir,
Okay, dropped off.
Hello, Neha?
Sagar, I think she has dropped off, so maybe we can take the next question first, and we'll have her on the queue soon.
Sure. The next question is from the line of, Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
Yeah, thanks for the opportunity. So just to continue on this milestone income, is that the reason for the quarter-to-quarter drop in the gross margins for the base business?
What's the question? Is that the reason?
Yeah. So I mean, basically trying to understand the dip in the gross margin as well, both quarter-to-quarter as well as year-over-year, when we had good, you know, relaunches or certain complex product launches as well in the quarter?
So, if you see, basically what I given answer for the first one, we kind of supplied more of Heparin because of the new GPO contract we got. The contribution margin on Heparin is lower compared to that. So the margin I think is around 25%-30%. So we, the volumes what is supplied to last quarter, it's almost doubled. So that kind of diluted the overall margin. But it will normalize over the period because we supply. When you start your contract, you supply open stock, so that has taken away our capacity with low margin products. But that will be fine from next quarter.
Understood, sir. And from the biologic side, you know, while the facility has, was being, you know, from a, from a specific vaccine point of view, and since then the facility has been available, it's taking quite a long time to, you know, get the new contracts. And, that is one. So if you could share further there, and this collaboration which involves large-scale contract manufacturing. So here, we're not sharing too much of details, but what can be the timeline to, you know, understand the commercial benefit of this collaboration?
While we can't name the company, probably it's a quarter, I would say. Some clarity will come up on how this happens. So the discussion is around investment in the large-scale production compared to what we have. For some of the biologics, what they've filed and some what in the commercial stage. And also in parallel, also licensing some of the molecules for our other markets, three or four biologics products. So it's a combination of CDMO business to expand, as you know, in a lot more attractions come in the recent months for Indian companies. So I would say it's a good sign. So this is in that, I would say, in that direction.
CDMO, combination of CDMO business for some of the commercialized and yet to be launched products, and, in licensing of some of the molecules, which have gone into clinical. So it's a combination of that. So more clarity we can give you in a quarter or so.
Understood, sir. Just extending to this as an industry phenomenon of this, this BIOSECURE Act, is that also sort of benefiting us or any sort of the Chinese promoter company, we are not party to that?
Yes, yes, for sure. I think what we, I just mentioned, I think that also is, result of, this, I would say, because I think, we are seeing more inbounds than compared to before. They're looking India as a second, base for a lot of companies, to have, you know, to de-risk themselves. So I would say, yeah, that would, benefit, the CDMOs in this space.
Got it. Thanks much again.
Thank you. The next question is from the line of Neha Manpuria from Bank of America. Please go ahead.
Yeah. Am I audible now?
Yes, ma'am.
Yeah, Neha, it's better.
Okay. Thank you. Sir, we saw Fosun sell a pretty large stake in the quarter. You know, have you had any discussions about how they are thinking about their ownership in Gland?... Do we think it goes down further? You know, and, you know, over the longer term, we have talked about evaluating front-end in the U.S. . You know, how should we think about that?
Yeah, from a corporate perspective, you know, we don't really discuss about the shareholding. We only talk more about the strategies and how to expand businesses in different geographies with their network. But there's no communication around the equity and how they sell. We only know post-facto, I would say. What's the other question there?
On the long-term strategy for the U.S., because I think last year we were considering, you know, or evaluating a hybrid model of possibly going front-end, on our own. So is that still on the table?
Yeah, it is. It's still on the table. It's on the table. We are evaluating, but we can't comment. It's still early. But it, it's not like, you know... Our core focus will be CDMO, and also getting into more complex CDMO. That is the focus for the company. With more and more companies approaching us on the bio side, for sure, that will be a key focus in terms of investment. At the same time, the general business is key for us, so that will continue, but we have to see what are different options, so that the base business will grow at least at a certain rate while we build the other part of the business.
Understood. And did I get the previous comment right, that the biosimilar, you know, the discussions that are going on would require new investments in batch release manufacturing?
Yes. So because while we can take on the CDMO and the smaller scale batches-
Mm-hmm.
But it also requires investment to increase the capacities what we have. And since it is backed up by CDMO contracts and also the commercial volumes, so that evaluation is happening. So if it's backed up by that, then we'll work out the investment plan for that as well.
Understood. One housekeeping question: If you could just quantify the milestone and the profit share number for the quarter, please?
Give me a second.
Yes.
Profit share for this quarter is 10%. T his is I'm saying ex Cenexi, and milestone is 9%.
Okay. Thank you so much, sir.
Thank you. A reminder to all the participants, you may press star and one to ask a question. The next question is from the line of Kartik, who's an individual investor. Please go ahead.
Yeah, good evening. Actually, is there any one-off from Cenexi in this quarter?
No, no, there's no one-off. So it's, it's a continuous CDMO business, so there's no one-off.
Okay. Where do we expect the next leg of growth to come from for Gland? Are we continuing the plasma project and biosimilars, which we are discussing in the previous quarters?
Yes, that, that's continued. And also the complex products, you know, we have filed the six products until now, so few are good products on that. And, you know, one suspension product we filed last quarter out of the seven what we filed. So that's another growth lever, I would say. And, and of course, the bio CDMO side, where we're seeing a good traction, including the plasma project.
Okay, thank you.
Thank you. The next question is from the line of Bino Pathiparampil from Elara Capital. Please go ahead.
Hi, good evening. Mr. Sadu, just a question on the U.S. market. You know, last couple of quarters, your commentary was very positive in terms of customers coming back and queries going up, a lot of demand for products, et cetera. Is that, pretty much as great as of today, or, you have seen a bit of cooling off from that hike in the demand, over the last couple of months?
No, I would say the positive is still there. I mean, it's no different than what you have seen. If you see over the- if you see compared to the last year, it's almost the volume-wise, it's gone up by almost 30%. So, but if you see by previous quarter, the quantity can't really compare. It's almost same, I think, gone down by 2%, U.S., but more to do with how many batches you can make on those lines. And it's more a capacity situation on customer lines, which impacted us a bit. But otherwise, the demand is there, and on an annual basis, we'll still be on target to, you know, what we have envisaged the beginning of the year.
Understood. So, last quarter, there was a high element of milestones. So excluding that, this quarter, so can we look at this quarter as a sort of maintainable base on which we will see some improvement of as the quarters combine?
Yes, I would say so, because, you know, like I said, the milestone income was almost, I think it's 16% last quarter because of some complex products getting licensed out. And, you know, this is not like... It depends on which quarter you license this kind of products. Not every quarter you are filing a complex product. So, but on an annual basis, I think it's still, moderated and, the business should grow.
... Got it. One more question on Cenexi. So next quarter, when you say that we'll have a three-week called shutdown, if I say roughly one month shutdown, is it fair to assume that the Q2 revenue will be 2/3 of Q1 revenue? Is that a right way of looking at it?
Give me a second. It's not clear. Can you repeat that question? A little, not clear.
Sure. So my question is, you know, in Cenexi, we talked about a three-week, four-week shutdown in Q2. So, is it fair to assume that the Q2 revenue would be 2/3 of one quarter revenue level?
Yeah. Correct. So, that's correct. But at the same time, we're also using that time to install,
Yeah
... a new line, so which will help us actually to produce more volumes in the future. So it's not that we're completely wasting that time, I would say. But at least utilizing that time to install a new high-speed line, which will increase the volumes in the future.
Besides that, every year we have a shutdown of roughly two weeks in all our plants because of the summer break and heavy maintenance. The actual impact is only one week more because of the installation of the new line.
Got it. Thank you. Thank you very much.
Thank you. The next question is from the line of Rahul Agarwal from Himalaya Capital. Please go ahead.
Thanks for the opportunity, sir. Can you quantify the extent of the milestone and profit share component for last quarter versus this quarter?
Yeah. So, by last quarter, do you mean Q4 or Q1?
Yeah, Q4. Q4 of 2024. Yeah.
Q4, profit share was same, 10%, and milestone was 15%.
Okay. This quarter, the profit share is 10%, milestone is nine, so there's a gap of 6% on milestone.
That's correct.
Milestone, I'm assuming all this is 100% gross margin, so it flows straight down, so it affects both the gross margin and EBITDA margin.
Yeah. It may not be 100%, because there could be some costs related to the batches filed and all, but largely, yes.
Got it. Got it. Putting it together, sir, from a full year perspective, what sort of a growth do you see in your base business ex of Cenexi for the full year?
The mid-teens, that's what we guided and,
From a margin profile perspective?
So, EBITDA around 30-33.
Understood. Thank you so much.
Thank you. Ladies and gentlemen, as there are no further questions, I would now like to hand the conference over to Ankit for closing comments.
Yeah. Thank you everyone for connecting today. We understand most of the questions are addressed, but if there are any follow-on questions, please do feel free to reach out to us. We'll be available and happy to address. Looking forward to host you the next quarter as well. Thank you.
Thank you. On behalf of Gland Pharma Limited, that concludes this conference. Thank you for joining us, and you may now disconnect.