Conference is now being recorded.
Receive an EBITDA after federal costs. First, I will highlight our consolidated performance. Our consolidated revenues stood at INR 15,056 million, showing a growth of 7% over last year's quarter one. Our consolidated EBITDA took INR 3,678 million, marking a strong 39% increase year-over-year. A partial portion of this growth was driven by EBITDA expansion over this business, complemented by break-even EBITDA from Cenexi, its significant turnaround. Consequently, our consolidated EBITDA margin grew from 19%- 24% this quarter. Next, I will outline the performance of our base business and plans, excluding Cenexi. Breaking down our performance by market, we had a strong quarter in the U.S. with successful launch of nine new molecules during quarter one FY 2026. This included important products like Epinephrine, Acetaminophen batch, and three new strengths of Vancomycin. The U.S. reported INR 7,443 million in revenue, contributing to 49% of our business.
Our other regulated markets, including Europe, Canada, Australia, and New Zealand, showed good growth, increasing 34% year-on-year, led by portfolio maximization initiatives across our partners. These markets now make up a significant 25%- 27% of our total revenue. The rest of the world market contributed to INR 2,978 million in quarter one FY 2026, representing 20% of our revenues. Despite a modest 5% increase in these markets, that's due to a softer order intake in some key regions. Lastly, the Indian market generated INR 594 million, accounting for 4% of our quarter one FY 2026 revenue. Moving on to the R&D, our total expenditures for quarter one FY 2026 were INR 460 million, which is 4.4% of our base business revenue. During the quarter, we filed one product and received nine new approvals.
R&D remains a cornerstone of our strategy, and we are confident that our new product portfolio will drive growth and profitability in both near and long term. On the operations front, all our units are compliant with various regulatory guidelines, maintaining a strong commitment to high quality. We also focus on monitoring our cost base to ensure our business remains highly competitive and ahead of the curve. Cenexi has been the highlight of this quarter. Our strategic initiatives over recent quarters are now delivering tangible financial results. After several quarters of negative EBITDA, Cenexi reached break-even this quarter. In quarter one FY 26, Synapse's revenue was EUR 48 million and gross margin improved to 80% from 78% last year. EBITDA was EUR 0.9 million. We are confident Synapse's performance will continue to improve. Alain will provide a detailed update shortly.
We remain committed to enhancing Synapse's financial performance and assuming our strategic objectives for this acquisition. Before concluding, I will provide a brief update on our key demand and supply priorities outlined when I became CEO two quarters ago. We remain committed to building capabilities and expanding our global reach to drive long-term value. On the demand side, our focus remains on enhancing our footprint and launching new products in high-value, high-growth, Rest of World markets. We are also leveraging our strengths in specific therapeutic areas and actively exploring demographic opportunities to achieve significant growth in India. In the U.S., our primary goal is to add new customers and gRoW our share of business with existing partners. All of this is backed by an accelerated portfolio strategy that emphasizes core development in licensing and strategic partnership in newer modalities.
On the supply side, our priorities are focused on maintaining quality and cost literacy. We are continuously focused on competitiveness and upholding our industry-leading quality and compliance records. We are continuing to strengthen our leadership tools with new hires and building capabilities across all functions. With this, I would like to hand over the call to Alain for more detailed updates on Synapse's performance. Over to you, Alain.
Thank you, Mr. Giri, and good evening, everyone. As emphasized by Mr. Sadu and Mr. Giri in their remarks, we are pleased to report that Cenexi reported a break-even EBITDA this quarter. This achievement reflects our continuous efforts to streamline operations and optimize costs. While we are still working toward our desired financial performance, this marks a strong beginning and emphasizes both our strategic intent and the progress we are making. To provide a more granular perspective, let me walk you through key updates at the site level. Production at our Fontenay facility has been on track with the plan. We were able to improve our order shipments and reduce downtime. The transfer of products to our new ampoule line is progressing well, thus increasing our production output. Our results this quarter also reflect the benefits of price increases negotiated last year with our customers.
As we had reported, we have also concluded the required actions pertaining to the Q3 FY 2025 ANSM inspections. A new inspection took place in July to monitor the progress of our CAPA plan. We remain focused on streamlining operations on the site and adding further volume. The operations at Eaubonne have remained on track with our recovery plan, and we continue to see steady progress with the ongoing tech transfer projects under development. The installation of a new pre-filled syringe line, which is projected to be operational at the beginning of calendar year 2026, remains on track and will substantially increase our capacity in the high-demand CDMO segment. The business from BrainLalu and ONI remained robust and delivered a solid performance this quarter. As updated previously, our two new line utilizers are being installed at BrainLalu, and their qualifications will be concluded by the end of the calendar year 2025.
In parallel, engineering studies for the installation of a new vial line under isolator with automatic loading and unloading of the line utilizers are progressing well. The long-term prospects for this business remain robust, with high-value projects in our tech transfer program. Besides, our pipeline of new leads in BrainLalu is gRoWing fast, with new projects under study in hormones, blood derivatives, biologics, and of course, cytotoxics. Q1 FY 2026 has marked the beginning of a meaningful turnaround. We remain firmly focused on our previous commitment. It is to deliver a positive EBITDA in Q3 FY 2026 after a to-be-expected low Q2 FY 2026 due to our thermal shutdown. Thank you for your time. I will now turn the call over to Ravi to discuss our financial performance. Ravi, over to you.
Thank you, Alain. Good evening, and thank you for being with us on the call today as we review our commercial performance for the first quarter of the fiscal year 2026. We are pleased with the steady growth in consolidated profitability year-on-year, driven by improvement in our gross margins, which has reflected a strong positive momentum, improving to 65% from 60% in Q1 FY25. This enhancement was largely on account of higher contributions from favorable raw material costs for several key products as base business. Excluding Cenexi, our base business gross margins stood at 59% in Q1 FY26, up from 53% in the same quarter of previous year. The consolidated EBITDA margin also improved significantly, reaching 24% from 19% in the corresponding period of FY 25. This uplift was driven primarily by a strong gross margin and various cost control initiatives across our base business.
At Cenexi, EBITDA break-even was achieved, supported by higher volumes alongside stable operating expenses. Excluding Cenexi, our base business delivered an EBITDA margin of 35% for Q1 FY 26, compared to 29% in the same period last year. It is worth mentioning that the company launched ESOP 2025 scheme in May 2025 to motivate key employees and also to align with the interests of investors. On ESOP grant of 843,685 options, a non-cash expense amounting to INR 59.48 million was included in this quarter's employee benefit cost. Adjusted for this expense, our base business adjusted EBITDA stood at INR 3,661 million. Our net profit for the quarter reported a strong 50% year-on-year growth to INR 2,155 million compared to Q1 FY 25. During the quarter, we achieved a PAT margin of 14% compared to 10% in Q1 FY25.
Other income, primarily consisting of interest earned from bank deposits and foreign exchange gains, amounted to INR 575 million in Q1 FY26. This is higher than the INR 440 million reported in Q4 FY25. Our R&D expense for the quarter was INR 460 million, decreased from INR 489 million in the same period last fiscal year, largely due to timing of the expense, while all our R&D programs remain on track. This quarter's R&D expense represents 4.4% of our revenue on an ex-Cenexi basis. On a standalone level, our effective tax rate was 25.7% for the quarter. As of June 30, 2025, our total cash and equivalents at the group level stood at INR 30,139 million, including non-callable deposits of INR 3,960 million. Debt at Cenexi level stood at INR 3,145 million. Cash flow from operations during Q1 FY 26 was INR 2,620 million.
Our average cash conversion cycle was 161 days for the first quarter, compared to 172 days at the end of FY 25, largely on account of better receivable and payable management. Total CapEx during the quarter amounted to INR 786 million, mainly deployed in Cenexi's DLF for the new projects and other replacement and maintenance standards. With that, I would now like to request the moderator to open the line for questions. 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, then one on the attached phone. If you wish to remove yourself from the question queue, you may press star, then two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the questions are assembled. Our first question comes from the line of Saion MU.K.herjee from Nomura Securities. Please go ahead.
Yeah, hi. Thanks, and good evening. Sir, can you provide the profit share and milestone number for this quarter, please?
Yes, the milestone revenue is about 9%.
9%.
The profit share is 12%.
Okay. The second question on the pre-filled syringe cartridge capacity of 40 million units, which is available, and 140 million units that you're planning to go. If you can share the timeline and how much of this capacity, given the GLP-1 demand, you expect to sort of come through this year in FY 27 and FY 28, if you can sort of give some color as to how you see this capacity getting filled up.
The 40 million capacity is already in place, and we have already filed, and the deadline is already approved. As you have heard in the commentary, we have launched it in a few markets on deadlines. The 100 million capacity is expected in September and installation in November. The mark, which is March 8th, is ready for investment and commercialization. There are a few contracts we're discussing with partners for that line. Anyways, we're going to be in Turkey. Most of the initiatives will be filing from that line, and that could be good enough for our launches post-COVID.
Sir, how much of this 140 million? What is the amount of, you know, quantity we would be supplying, let's say, in this fiscal and 2027 and 2028? I know like some of this may be from a long-term perspective, but given the visibility on contracts that you have in place now.
Right. Next, we got on 20 million in the first year, and then we've got up to the next few years, depending on which markets you get approved.
20 million you're saying this fiscal, fiscal 2026 or 2027?
27.
Okay. Understood. Thank you, I'll join that.
Yeah.
Thank you. Our next question comes from the line of Neha Manpurya from Bank of America. Please go ahead.
Yeah, thanks, sir. This is my question. My first question is on Synapse. Could you take us through a little bit on the break-even that we've achieved? Is this because of certain plans as you see lots of huge lower, and why do you think this will be sustainable? Based on this, you know, what should be the margin that you think Synapse can now achieve for next year? Is a low-fee margin possible, or would it still be in the higher margin?
Alain, you want to take this? Okay. Neha, I'll ask you the question.
Yeah. In Q2, all sites have contributed to a strong performance. Of course, DLN, ONI that has had a long-term positive EBITDA continued on the trends, but we started to see a recovery both in Fontenay and in Eaubonne, which have been the lower performing sites in the past 12 months. That's driven mainly by an increase of volume as well as a much reduced downtime and also the result of all the actions that we have initiated in order to be more productive and more efficient.
We can ask, you know, out of the few facilities, which one of them, you know, probably is the largest driver on profitability and what's the scope to improve margin there?
If we look at Q2, as I mentioned, both Fontenay and Eaubonne have sharply increased their results. ONI and BrainLalu continue on a very positive trend, but most of their side is coming from Fontenay and Eaubonne that had been underperforming in the past 12 months.
Neha, just to add, if only sites that we are starting to deliver to demand, and the line we survived in March, that kind of helps us to catch up with some of the back orders and also increase the capacity. That has added the company and brought into screen. From the HSE side, two products got launched, Interpur and Kishida and Migdel, vaccine product release. Those projects got commercialized and there was a volume increase. That kind of helped HSE also to increase their revenue. There were actions taken by Alain in terms of increasing the transfer prices for several products, and that also helped in increasing the profitability.
Next year, sir, do we think, you know, Synapse can now comfortably do a low-fee EBITDA margin? Would that be a fair assumption given the progress we've seen in this quarter, or probably it's too early to call that.
The next quarter, because of the summer shutdown, this next quarter could be a low fee.
Next year, sir, to reach.
For the year, I think moving forward from October, I think it will be a bit positive, and we'll ramp it up slowly to get to the high low teens or high single digits.
Okay. Understood. My second question is on the U.S. business. If I look at the performance in this quarter, obviously, there's something else. As we think about that mid-teen growth that we talked about, when do you start seeing improvements in the U.S. business to get to that mid-teen growth? What's the drive? You talked about the dry powders here and more. When does that start playing through? When does this complex approval actually start reflecting in the revenue numbers for the U.S.?
We're still on track for the admin budget. Yeah, I would say, you know, we are achieving our budget in the first quarter. We are on track to get to the mid-teen growth for the year. The CMS project, the Nile product just got launched last quarter. You see that, you know, you see the numbers in Europe, why it has gone up. They say that product was got launched. The other one, the CMS dry powder, the Danish approval has come through line-wise. Now they'll be submitting the dossiers next quarter. The beginning of next year, those products will get launched in Europe and other markets. That will be a big ticket item in terms of the CDMO business. The other big thing in the U.S. will be dalbavancin launch. That will be the September quarter. That's going to track a year in terms of the approval and launch.
These are the two big events that will help this growth coming back. Otherwise, everything else is in line with our internal budget.
I'm sorry, which was the second one you mentioned in September or listed?
The Eribulin. Eribulin launch in.
Okay. Okay. Got it. Okay. Thank you.
Thank you. A reminder to all the participants, if you wish to register for a question, please press star, then one on your touch-tone phone. Our next question comes from the line of Tushar Madudane from Motilal Oswal Financial Services. Please go ahead.
Thank you. Thanks for the opportunity. Any other?
Sorry.
Yeah, Tushar, go ahead.
Just for me, we have retailed, how much overall business across the geography you would have made this quarter?
We've done it in Switzerland, but I think we launched in the U.K. and one other part in Australia. U.K. and Australia got launched this quarter. Previous quarter, again, I think the two markets, right? South Africa and Saudi Arabia, two markets. It's now four markets. It started with one.
How many more? I can't see in the remaining quarters of 2026?
I can't say because it's our partner's product. It's a global agreement.
Sir, you're just formalizing insights once, like in the next year, when the other subsidiaries get as a business opportunity for them?
No, it has its own markets, right? I mean, Liraglutide and Semaglutide both have its own markets.
No, from the manufacturing capacity for this.
No, we already have enough capacity. We have currently 40 million, and that should suffice for the next few years because the major product is going to only come early 2030s, right?
That is after the other line. For the semi-regulated market?
We'll have that price. The other line is ready by the first quarter of next year. That should take care of the demand. Till that time, we have enough capacity.
Got it. Sir, I missed the name of the, you know, potential products for the U.S. market which will drive them if you could repeat.
One is dalbavancin, and the other we already showed is the CMS contract. That's not just US. That's also European. The second one is a CDMO for sure.
Okay. This last week, once again, Q2 sort of dip in profitability for Synapse and then Cenexi. Full year 2026, sort of what kind of EBITDA margin one should think of?
Give me a question, sir. Yes, I mean, I like this quarter's future around 25% stack. Any hope for the future?
For Synapse?
You want EBITDA or?
EBITDA.
EBITDA margin.
Okay.
We are estimating the EBITDA ramp-up happening in Q3 and then Q4 also. Q2 would be a little lower because of the one-month summer shutdown. Accordingly, we'll have the full year EBITDA number.
Okay. You said you were indicating the full year EBITDA margin of Gland Pharma as the 24% to be considered?
I think combined, the Gland and Synapse puts around 24%- 25%. This is the current quarter's EBITDA totality.
Thank you. Our next question comes from the line of Binopati Parampis from Elara Capital. Please go ahead.
Hi. Good evening. Could you please elaborate a bit on the Semaglutide manufacturing opportunity for you in the near term, specifically for next financial year? How big can that be based on your capacity, your contracts, and your outlook compared to the overall size of the company?
I do not know. As I just tell you, we are today at 40 million cartridges up and running. We are coming to 100 million again. Enter next year, you know, FY 2027 will be one of the top year cartridge capacity. It's 140 million cartridges. We also have contracts where we are talking to four types of customers: Indian customers for global markets, global customers, Indian customers for India markets. Finally, we are talking to also some more players for global markets. As we are doing this exercise, we are here to sell our capacity. The capacities are being ramped up. It will take some time for us to tell you exact capacity being sold by the end of quarter four, 2026.
Right now, we don't have a number that how FY 2027 will look like, but we are being approached by many customers who want to launch their GLP-1s in India and global markets.
Understood. Did I hear it correctly that the entire 140 million, that is the new 100 million as well, will be ready by the end of this financial year, by March?
That's correct. 40 million is already ready and another 100 million by March. This is a commercialized set, ready for commercialization in the market.
Understood. I believe what you do is just the cartridge, getting the cartridge and the API, and then you know filling the cartridge with the API. That is the only activity that you do. Am I correct?
It is a fill-finish CDMO line. You know, we are not developing our own Semaglutide. It is a fill-finish activity that we will do.
Okay. Sir, if I may ask, the kind of contracts that you are getting, where does the API come from? Does the customer directly get the API and ask for a fill-finish, or do you go to source the API as well?
No, no. These are all developed by partners and transferred to us. API sourcing will be done by them and developed by them. Either it's internally developed by the partner or outsourced. We have currently agreements for Liraglutide and Semaglutide with partners and more are upcoming. Most of them are, but we don't source for them.
Understood. Last one question. Given the so-called FDP shortage in the market for Semaglutide, extra price, etc., is this fill-finish activity going to be of a significantly higher margin profile than the other fill-finish lines that you run?
The contribution could be higher because of the volume you can produce in a batch, a cartridge. It all depends on how the market behaves. Once you come closer to launch it in various markets, it's not really common. We can only comment on this. Contribution margins will be better than others because our throughput isn't given on a daily basis.
Is the throughput higher because of the nature of the cartridge, or is it because of a technical reason?
We are in fear of the machine as well as the fill volume, so it can produce more units compared to a vial.
Understood. Got it. Thank you very much.
Thank you. Our next question comes from the line of Nitin Agarwal from DAM Capital. Please go ahead.
Thank you for taking the question. Following up on these previous questions, on these capacities that we have, you know, these are capacities for multi-RoW cartridges that end pen assembly, or these are largely wire-filling capacities?
These are cartridges. These are not vial lines. This is a bulk cartridge line, and these lines are integrated with the pen assembly line.
Okay. From a regulatory perspective, the next 100 million wires cartridge capacity that you'll pick up, that you'll put up, for what kind of regulatory approvals are you looking at? For which kind of, which, A, within 40 million, what regulators will approve this capacity? For you to get incrementally approvals for the next 100 million, what kind of time frame that takes after the confirmation?
This line is part of the 10th week. They will have other lines approved, including this Gland cartridge. The approvals will be faster, especially in the U.S. and Europe, because the submittal is approved for these markets already. It's easier. We have seen Nira getting launched in other markets. This is a similar block, and it's easier compared to a new line, new submittal.
Okay, thank you so much.
Thank you. Participants, you may press star and one to ask a question. Our next question comes from the line of Abdulkader Puranwala from ICICI Securities. Please go ahead.
Yeah, hi. Thank you for the opportunity. For the first question, with respect to your U.S. market growth for the base business, any commentary you would like to provide as to how the growth would arise in this particular portfolio in four years ahead?
Hi, Abdulkader. Can you again repeat your question, please?
Yeah. My question is with regards to your U.S. revenues, which has declined at around 2%. Within that branch portfolio, the growth has been - 5%. I wanted to understand, you know, how would this shape up in the near term? When we see this business, when we talk about the mid-teen kind of a growth rate, how would this business growth plan work?
Yeah. I think it's more to do with the timing. Actually, the inox supply in this quarter was around INR 70 million, which is somewhere around INR 1300- INR 140 0 million. It's more about the timing because some of the SKUs, the large purchase SKUs, are not supplied every quarter. If you actually exclude the Inox supplies, the revenue growth in the U.S. is almost like 11% market growth. Other than that, it's more to do with the timing issue because on an annual basis our inox is still intact in terms of volume and revenue. That's the main reason why we saw that growth. Otherwise, it's been lacking.
Understood, sir. Sir, just one more if only. Any update on the biologics sprouts similar prior to you had with Dr. Reddy’s and one other customer? You know, when should we look for commercial revenues coming from that venture?
That started from July 1st. It's now been the collaboration started. The team is in place now from their side. You'll see some revenue coming from this quarter onwards from the Dr. Reddy’s collaboration. On the other projects, still we are working on RFPs and the commercial discussions are happening on the NDS two projects I'm reporting with them. That will take some time because that's more tech transfer activities that will happen next year or so. From the Dr. Reddy’s projects, we'll see some confirmation coming from this quarter.
Okay. Sir, if you have to track different quarters ahead, the collaboration would be for which market?
This is more to do with pilot scale batches at GLAS. It's not specific to product now, market now. It's more pilot scale batches going for clinicals and all that.
Got it. Thank you.
Thank you.
Our next question comes from the line of Dinesh Bhatak from White Oak. Please go ahead.
Thank you for the opportunity. Can you have one 40 million cartridge fill-finish capacity available for FY 2027? You mentioned that you're working with various categories of clients. How much utilization do you expect for the full year FY 2027?
FY 2027, the utilization for the new line won't happen because most of the markets will open up later, right? RoW opens up a few markets next year. The utilization may not be much, but we're also talking to not just GLP-1s, but also some of the other molecules to see if we can fill up the capacity for the next few years. The majority of the capacity will start filling up from 2029- 2030.
Okay. All right. Okay.
Thank you.
Thank you. A reminder to all the participants, if you wish to register for a question, please press star and one now. Our next question comes from the line of Rahul Jeewani from IIFL Securities Limited. Please go ahead.
Yeah. Thanks for taking my question, sir. You indicated that for the GLP-1 products for FY 2027, you will be commercializing around 20 million pens and cartridges. What kind of a fill-finish pricing are you working with? As far as I understand, the pricing would be dependent on how the end market balance came out, but some ballpark number would be helpful. Yeah.
Can't really comment on the pricing because, and also, we're not dependent on end pricing because in the CDMO, we have a fixed conversion cost paid for each pen. That kind of fix is not related to the end market. You can't even say how much because it depends on the contracts and what pricing we are doing with the particular customer.
Okay.
This 20 million pens commercialization, which will happen in FY 2027, will largely be for the RoW markets, and hence you will book that revenue as part of the RoW business.
It's a combination of some in the several markets that you know, even you have Nira, which is getting launched in certain markets. Likewise, Sema will also be launched in a few markets.
Okay. Sure, sir. On the base business growth, while we have commented over the past three or four quarters that the base business growth should pick up to a mid-teen kind of a number, this quarter as well, the base business grew only 3%. We appreciate the fact that there was volatility related to Enoxaparin, but Enoxaparin and heparin are our two largest products, which will have just a quarterly, let's say, kind of a volatility. When do you think that the base business growth actually starts accelerating or improving to this mid-teen kind of a number?
Thanks. It's just that these two products, they're not just mentioned about, whether it's Jalga or the CMS dry powder projects that will start coming up in the last two quarters. That also gives a big jump from average raises for the U.S. We'll hit that mid-team.
Okay. Is this mid-team including Synapse at an overall company level?
Overall, yes.
Oh, thank you. That's it for my question. Thank you.
Thank you. Our next follow-up question comes from the line of Saion Mukherjee from Nomura Securities. Please go ahead.
Yeah. Thanks for the follow-up, sir. I just wanted to check on, I think you received approval for generic Vyzulta latanoprostene some time back with exclusivity. I mean, is that a product we expect in the near term, or is this a few years out?
It's a few years out. Depending on the settlement on the patent, it's a few years out.
Not in the next two years. Would that be a fair assumption to make here?
I think that's a good thing. It's FY 2029.
Okay. Understood. You mentioned about building out in the RoW market, and it would take some time to build that out. How should we think about your approach in the various RoW markets, and what kind of ramp-up, what kind of scale you are looking at?
Finally, to see RoW, we in many ways have arrested the rebirth, and this quarter is a quarter of growth on a QoQ basis, 24%, on a YoY basis, 5%. What we are doing in RoW is having a portfolio approach. What we have done first is classified countries of RoW as class one, class two, class three. This is the kind of portfolio optimization and focus that we needed. Second, what we've also done is we are now tracking all the registration activity, some old registrations which were actually in the past decades active, and having a high kind of tailored review with the partners on the grounds. These are all tactical things, but strategically, we are launching, we are finalizing a portfolio which will place us among one of the top-tier injectable companies in that country.
A lot of things are happening tactically and strategically, but we have reasons to believe that RoW business can double up over a few years from now.
Okay, sir. One last question if I can. A few years back, you had mentioned about China market collaboration with Fosun and its presence in various markets. I was just wondering what kind of involvement Fosun has in the strategic direction for the company and the business as a whole at this point?
Overall, I think Fosun is a good partner. We have access to the entire ecosystem from an API sign and all of that because of Fosun. They're not day-to-day, Alain. If I were to again comment on a particular China market question, we have four approvals, four more pending. We do have some value that we are generating. China, again, is a very intermediate market. We want to really push our approvals and the registrations more in China. It takes a lot of time, and there is a GDP overhang. That's where the production of molecules becomes very, very critical of where we want to play in China.
Okay. Okay, sir. Thank you.
Thank you. I remind all the participants, you may press star and one to ask a question. Our next question comes from the line of Harish Bhatia from Bandhan Mutual Funds. Please go ahead.
Thank you. Am I audible?
Yes, sir, you're audible.
Thank you, sir. What is the, able to call out the, order of selection? I think the last quarter, it was close to EUR 100 million if I'm not wrong. For this quarter, what is the order book?
The order book is approximately around EUR 85 million- EUR 90 million still. Although this quarter, we produced a little more to clear some backlog, we do have a backlog still in Synapse.
Considering the EUR 48 million bandwidth, assuming hypothetically this is the bandwidth to work with, on an annualized basis, on the expanded capacity base, what would be the broad capacity utilization for the Cenexi business, as that's across all the bands?
Let me slice and dice for you this one. We do have capacity available in HSC, VLA. ONI and Fontenay is where we are, you know, a piece of the utilization. Therefore, their price increases, getting higher value formats, getting new businesses for new value or more value is the strategy.
Just to add, Harish, in Synapse, the Fontenay line here has recently been started commercially operating. This will go up from this quarter to around what Fontenay has done. Eaubonne site, like Mr. Sadu explained a little while ago, is that it was the two products launched, and there are ample runways for further capacity utilization. There are further plans in the tech transfer project happening, so it will go up further at Eaubonne site. At VLA, as you know, there are a few new layouts recently set up.
A few more are coming once there's one new vial and we expand it. All this will, in the next year, more or less be operational. Then we'll see how revenue scales up significantly on this level.
What did you try to say? I understand that Fontenay would be more of a product mix, rather than a pure capacity user, but that's more to do with HelloVillage and VLA. Would it be fair to say at current capacity, you can very easily go to next year of EUR 40 million or EUR 100 million just based on the current capacity on the expanded capacity base?
Expanded capacity definitely would be, before the VLA's new line growth package, it should be around between 50 million- 55 million before VLA's wire lines. When that gets commercialized next year, it would further go up.
Okay. Just one clarification, I think you had already spoken about this appeal cartridge class. Just to refer from memory, it's a very basic question on the GLP-1 cartridge capacity, fill-finish and cartridge capacity. The 40 million going to 140 million units at the cartridge level. We assume that that's integrated to the pen assembly lines as well. If I get you 140 million cartridge capacity for the fill-finish part, how many pens can we produce? The other way to ask this would also be how many multi-dose pens, slash auto injectors, single-dose auto injectors would we be able to provide, assuming that there could be some part that's complicated. Is that a fair understanding, or is it something that you are missing?
The pen line that we are introducing has around 160- 200 pens per minute. That's the kind of speed, which is a high-speed pen. If I understand your quote correctly, you're asking how many pens we can produce with it?
On the basis of the 140 million cartridge capacity, how much of that can be used to incremental pen output? I'm assuming that that would be output that we'll be able to provide to the customer at the end. Would it be multi-dose pens or single-lot auto injector pens?
Whether it's a multi-dose or single-dose, it's the same. Capacity-wise, it's the same 140 million. The strategies are similar. Only the assembly machine sales are the pens. The devices are different.
Okay. It wouldn't matter. Broadly, your 140 million cartridge capacity would be fundable across whether it is a multi-dose or a single-use thing.
Correct. Correct. Correct.
Okay. Thank you. Thank you.
Thank you. Our next question comes from the line of Ankush Mahajan from Sanctum Wealth. Please go ahead.
It is a current capacity of over 40 million and 40% current capacity utilization in the last quarter. My other one is that this U.S. runway revenue is in the range of INR 700 crore . How do you see the U.S. business considering this tariff sector? If there is a gene stocking by the distributors, how do you see, sir, in the near future?
On the cartridge, currently, it's a very limited capacity utilization because we rise only one from the commercialization perspective. We are also taking batches for exhibit batches and development batches for the other CDMO contracts we have. The Ozempic or Wegovy launch in commercial, it's a capacity replacement in the lower. Currently, most of the capacity is used for the development batches, not for the commercial. What's the second question?
On the US side, there are a few factors which will impact the U.S. business going forward. One of this was Enoxaparin timing that we have discussed, launches of CMS and anthologies. With all those factors and whatever we are doing, we still will be guided to growth in the U.S. We are still sticking to the guidance of growth in the U.S. market.
Sir, what is your question on the tariff?
Can I repeat the question, sorry?
There is a tariff announced from the Trump government. How do we see the U.S. business in the upcoming quarters now? Either distributors or there is gene stocking happening in the U.S. market or not?
Yeah. As of now, there's no tariff on pharma. We have to see how much and how it happens. As to the discussions we have, we will pass on to the partners, and they have to pass on to the different purchasing groups. That's how the discussion is. Everybody is now giving feedback of when and how much they will charge because the market says, because generic, they made the exemption, but it's mostly on the branded side in both large countries.
Thank you. Thank you, sir, so much.
Thank you.
Our next question comes from the line of Dhawal Khut from Jefferies. Please go ahead.
Hi. Thank you, sir, for taking my question. For the European market, I wanted to know which was the bigger growth driver between the new product launches, especially the Liraglutide , and the new tech transfer projects. Secondly, when we launch a product, is there any channel benefit that we get whose revenue may not be available in the next one, two quarters? As we gain the market share, it's again scaled up to that level.
The CMS project is an on-market product. It's only a transfer from the European side to the Gland side. There's no question about gaining market share. It's already there, and the live product is already launched. It's already approved. Dry powder, we just filed the pilot doses with the data. That approval is in the first quarter next year. That business should start. There's already a market which is already there. There's still a transfer of manufacturing side from Europe and Canada.
The VioAct growth that we've seen within the European market, what will you attribute it to?
Mostly at CMS dry powder that got launched in Europe and some of Liraglutide launched in the U.K..
Is there any benefits of channel selling in the Lira launch that you have done? What are the other markets that are scheduled for launch during the year?
For the other markets, there's no channel selling unless the U.S., which is more of a space. The other markets, where we have launched in South Africa and Saudi last quarter, and there's Mexico and a few other markets in pipeline to be launched.
Okay. That will occur this year itself, right?
Yes, yes.
Okay. Thank you. That answers my question.
Thank you. Ladies and gentlemen, due to the paucity of time, this was the last question. I now hand the conference over to Ms. Runjhun Jain for closing comments.
Thank you for joining us today. We greatly value your questions and our engagement during this session. If you have any additional queries, please feel free to reach out to us. We look forward to connecting with you again next quarter. Thank you.
Thank you. On behalf of Gland Pharma Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your line.