Ladies and gentlemen, good day and welcome to the Q4 FY 2025 earnings conference call of Gland Pharma Limited. 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 conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Ms. Runjhun Jain. Thank you, and over to you, ma'am.
Thank you, sir. Good evening, everyone. Welcome to the Gland Pharma earnings conference call for Q4 FY 2025. Today, we have Mr. Srinivas 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 is connected virtually from France. We will begin the call with business highlights from Mr. Sadu, followed by operational highlights from Mr. Giri. This will be taken up after Cenexi for the updates about 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 focused on our data management current estimates. These statements should be considered in light of the risk associated with our business.
The call is being recorded, and the playback and script will be available on our website shortly. With that, I hand over the call to Mr. Sadu for his opening remarks. Over to you.
Thank you, Runjhun. Good evening, everyone. Thank you for joining us today. On behalf of Gland Pharma, I welcome you to our fourth quarter and full fiscal year 2025 earnings call. Let me begin by providing a strategic overview of the business, reflecting on the past year, and outlining our vision for the company's future. Following this, Shyamakant will discuss our operational performance, Alain will provide updates on Cenexi, and Ravi will conclude with a financial review. Reflecting on the year gone by, FY25 was a pivotal year. While we faced near-term growth challenges at both Gland and Cenexi, I want to assure you that we used this time wisely to strengthen our foundation and sharpen our long-term focus. The global landscape has presented renewed complexities this year, especially with the announcement of reciprocal tariffs by the U.S. administration.
This has created a layer of uncertainty, particularly for Indian pharmaceutical companies, which have a significant presence in the U.S. market. Despite these headwinds, we have maintained our flexibility across demand and supply fronts. Gland's value creation journey remains anchored in the strategic execution of our operational model, and we foresee a promising growth trajectory ahead. Let me now take you through the key pillars driving our growth strategy. Starting with the base business expansion, we are expanding geographically with a strong push into emerging markets across Africa, the Middle East, Latin America, Asia Pacific, and the rest of the world region. There is substantial market opportunity in our approved U.S.-India portfolio and market formation opportunity by an upcoming pipeline of injectables post-patent expiry. In addition to recent successful new product launches, we are leveraging our long-standing relationships with key partners to deepen our global reach.
Next, we have made significant progress in expanding our manufacturing capabilities with new lines, including complex injectables and new delivery systems like pens and cartridges. A key milestone was our successful entry into the GLP-1 segment with the launch of liraglutide, given that we see GLPs as a crucial area for Gland's future. With two GLP-1 contracts secured and a strong market demand anticipated, we are scaling our cartridge capacity from the current 40 million units to an additional 100 million by CY 2026. We have broadened our capabilities to include suspensions, hormonal products, microscale bulk, microscale powder filling, while strategically focusing on ready-to-use products like dual and triple chamber bags. Importantly, we are also experiencing significant momentum in attracting major pharmaceutical companies interested in partnering with us for high-value formats like dry powders and have already successfully initiated several new CMO projects.
Moving to our R&D and portfolio expansion efforts, our strategy spans three focus areas: in-house R&D, complex products, and a co-development model. Our in-house R&D covers a wide range of therapeutic areas, supported by 371 filed and approved ANDAs and 1,748 global registrations. Our future pipeline now targets major therapies like ophthalmology, CNS, and cardiology, with near-term generic opportunities covering a $1.25 billion market, which is about 40 new ANDAs, a one to three-year pipeline targeting $2.12 billion, and a longer-term pipeline in a $2.34 billion market. In total, our in-house pipeline includes 71 new ANDAs with a $5.7 billion TAM. In FY 2025, we launched 31 new products in the US, and we expect this momentum to continue. Additionally, we filed 3 RTU infusion bag products, with 10 more in development as part of our 14 registered RTU bag products targeting a $530 million US market.
We are also focusing on additional complex injectables and have 19 products in this bucket, with six already launched and three more anticipated for approval, addressing an IQVIA market opportunity of approximately $6.5 billion . To accelerate our pipeline and portfolio expansion, we are pursuing co-development, wherein we are partnering with a specialty injectable development company for 15 products, out of which six are 505(b)(2) and 9 ANDA submissions, which are focusing on key therapeutic areas like immunology, chemo adjuvants, mineral supplements, pain management, endocrinology, and radio contrast agents. Gland is also building a robust CDMO setup for biologics, leveraging our existing biologics manufacturing capabilities. The biosimilar market is a significant driver in this effort. A key step in our strategic expansion into biologics is our collaboration with Dr. Reddy's Laboratories, which marks a significant step in this direction, with revenue contribution expected in FY 2026.
Furthermore, we have progressed on a non-binding agreement for CDMO collaboration with Shanghai Henlius Biotech, positioning us as a secondary manufacturing site for some of their key biosimilar products. To support this and future growth in biologics, we are expanding our bioreactor capacity by 15,000 liters. These collaborations reaffirm our strategic focus and investment in the growing biologics CDMO area. Turning to Cenexi, while we encountered challenges with below-expectation performance, we have made progress in defining this turnaround strategy. We recognize that acquisition pieces have taken longer than expected to fructify, but our strategy to achieve robust growth and profitability remains centered on high-value products. This necessitates a deliberate shift from our previous business model of low-value, high-volume business, which constituted 70% of our current operations, towards higher-value products such as refill syringes, lyophilized vials, and ophthalmic gels.
This evolution is expected to expand our net realizable value per unit and improve overall profitability. Cenexi's dedicated business development efforts are yielding results with the successful addition of new customers for refill syringes, vaccines, and lyophilized vials, aligning with this high-value focus. To facilitate these transformations, we are strategically investing in capacity enhancement and building business scale through increased automation. Finally, in parallel with our organic initiatives, we are actively exploring inorganic opportunities via mergers and acquisitions to accelerate complex product development, gain access to new technologies, expand our product range, and enter new markets. In summary, while FY 2025 brought challenges, it also reaffirmed our strategic clarity. We believe the steps taken by us across our key pillars will drive a positive impact on Gland Pharma's success and long-term sustainability. Thank you for your continued confidence in Gland.
With this, I will now pass the call to our CEO, Mr. Shyamakant Giri, to share his thoughts for Gland's road ahead. Thank you.
Thank you, Mr. Sadu. Good evening, everyone. Following my initial months at Gland, I have focused on understanding the business impact and aligning our capabilities with a strategic lever that will drive our market position and generate value. Broadly, my priority has been to identify key areas of profitability enhancement and new venues of growth. Before I outline the initiatives underway to strengthen our competitive position, let's discuss our quarter and full-year performance. In Q4 FY 2025, our consolidated revenue showed at INR 14,249 million, with a consolidated EBITDA of INR 3,475 million, reflecting a 24% margin, a 100 basis point increase year- over- year. Excluding Cenexi, our base business reported revenues of INR 10,332 million in Q4 FY 2025, a 12% year-over-year decline primarily due to the higher margin realization in quarter 4 last year as compared to this year in the U.S. and few major tender misses in ROW market.
This impact was partially mitigated by new product launches, and we anticipate sequential improvements as our pipeline commercializes. Encouragingly, the base business EBITDA margin expanded to 38% from 36% in the prior year, driven by favorable product mix and benefits of cost optimization. For the full year 2025, our consolidated revenue reaches INR 56,165 million, with an EBITDA of INR 12,689 million, resulting in a 23% margin. Excluding Cenexi, base business revenues were INR 41,248 million, with an EBITDA of INR 14,451 million, translating to a 35% margin. Our volume for full year 2025 grew overall by 4%, including new launches, aided by 9% volume growth in the U.S., again including new launches. Our new product launches in the U.S. are yielding results, thereby quarter 4 full year 2025 grew 10% sequentially over quarter 3 full year 2025. On a full-year basis, our new launches now contribute 6% to the total revenue.
In the U.S. market, we launched four new molecules during quarter 4, including Latanoprost, Midazolam, RTU bags, Dexamethasone, and New Strengths of Vancomycin. Other regulated markets, primarily Europe, Canada, Australia, and New Zealand, grew by 4% and now constitute 23% of total revenue. The ROW market contributed 17% in quarter 4 2025, amounting to INR 2,404 million, a 14% decrease due to tender misses and softer auditing intake in key regions. The Indian market generated INR 525 million, representing 4% of our quarter 4 FY 2025 revenue. Our quarter 4 FY 2025 R&D expenditure was INR 503 million, or 4.9% of the base business revenue. For the full year, our R&D investment totaled INR 1,922 million, that is 4.7% of base business revenue. On the compliance front, we received EIRs from the US FDA for our Dundigal and Pashamylaram facilities, confirming successful closure of recent inspections and reinforcing our commitment to stringent quality standards.
It's been a challenging year for Cenexi. While foundational groundwork for its turnaround is in place, results have fallen short of expectations. Our quarter 4 FY 2025 revenue was EUR 43 million, affected by lower production at the quarterly facility. Encouragingly, our gross margin improved to 79% from 77% in the prior quarter. Alain will provide a detailed update, but we want to assure you of our intense focus on Cenexi and the implementation of necessary changes to improve its financial performance and achieve our strategic objectives. Finally, a brief update on the key priorities outlined last quarter. We have been fortifying our capabilities and global expansion potential. We are currently refining our strategic direction and growth blueprint to ensure Gland will sustain success.
On the demand side, our priorities include enhancing our footprint and launching new products in high-value, high-growth ROW markets, leveraging our strength in specific therapeutic areas, and exploring inorganic opportunities to achieve significant growth in the India market. In the U.S., the primary focus remains on acquiring new customers and increasing our share of business with existing partners, supported by an accelerated portfolio strategy focused on co-development, in-licensing, and partnership in high-value injectables and needle modalities. On the supply side, our priorities are centered towards maintaining quality and cost-relative. We are continuously improving our operational efficiency to preserve our competitiveness and industry-leading quality and compliance records, sending our leadership team with critical hires and building capabilities across functions. With innovation, collaboration, and excellence as our guiding principle, I am encouraged by our progress and optimistic about Gland's trajectory.
Your continued engagement and insights are invaluable as we move forward together to build value. With this, I would like to hand over to Alain for a more detailed update on Cenexi's performance. Over to you, Alain.
Thank you, Mr. Giri, and good evening to everyone. As Mr. Sadu and Mr. Giri outlined, Cenexi's performance showed marginal improvements over the previous quarter, and we will continue to make calibrated progress towards achieving sustainable scale, with the dual aim of securing profitability and resolving the execution challenges seen in recent quarters. To provide a more granular perspective, let me walk you through key updates at the site level. Production at our Fontenay facility in Q4 was impacted by ongoing remediation activities following the ANSM inspection in Q3 Financial Year 2025, as well as the breakdown of two equipments that affected our performance in the first two months of the quarter. These disruptions led to reduced shipments and, consequently, lower sales figures.
On a more positive note, I am pleased to report that our new high-capacity ampoule line has started production as planned at the end of January and now enables us to better serve the needs of our customers. While operations at Herouville remain below breakeven due to suboptimal utilization, we have several ongoing tech transfer projects in development that are expected to contribute to this site's growth. We are encouraged by the ramp-up in the commercial production of a new ophthalmic gel, and validation batches for the inactivated vaccine project are progressing as per schedule. Furthermore, we have initiated the installation of a new pre-filled syringe line, which is projected to be operational at the beginning of calendar year 2026. This will substantially increase our capacity in the high-demand PFS segment and is expected to drive significant revenue per unit and overall value.
I am pleased to share that the Braine-l' Alleud facility has met its target for this quarter. Our two new lyophilizers arrived on site and are being installed. Qualification for this new Lyo capacity will be finalized at the end of the calendar year 2025. Additional vial and Lyo capacities are also planned to be added in our Belgian site in the next two years. The long-term prospects for this business remain robust, with high-value projects in our tech transfer pipeline. Finally, our Osny site continues to deliver a strong performance, thanks to a premium strategic positioning on hormones and anti-allergenic products' market segments and strong operational execution. In light of the challenges faced, last year's overall performance remained below expectations, and we believe financial year 2026 will mark the beginning of a meaningful turnaround.
We remain firmly focused on achieving our midterm objective of delivering positive EBITDA by Q3 financial year 2026. 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, and welcome everyone joining us today. We thank you for attending this call as we review our financial performance for the fourth quarter and the full fiscal year 2025. The FY 2025 revenues remained flat at INR 56,165 million. However, a key positive was the marginal improvement in gross profit margins. Consolidated revenue for Q4 FY 2025 declined as compared to previous years, while it improved from the trailing quarter of this year. This is driven by the reasons as mentioned by Giri in his commentary. In Q4 FY 2025, our consolidated EBITDA margin improved to 24% from 23% in the corresponding period of FY 2024, led by base business and improvement in Cenexi's profitability . Our base business, excluding Cenexi, exhibited increase in EBITDA margin for Q4 FY 2025, reaching 38% compared to 37% in the same period last year.
This improvement was primarily driven by enhanced gross margins and more efficient cost management practices. At Cenexi, the losses reduced due to improvement in performance in this quarter. Our EBITDA for the full year ending March 2025 amounted to INR 12,689 million, compared to INR 13,331 million in the previous fiscal year. The reported EBITDA margin for FY 2025 stood at 23% on a consolidated basis and 35% for our base business operations. While the base business margin improved due to better contribution and controlling costs, Cenexi's lower performance in some quarters in this full year impacted the consolidated EBITDA margin by 1 percentage point. Gross margin for Q4 FY 2025 also reflected positive momentum, increasing to 66% from 61% in Q4 FY2024, primarily due to higher contribution achieved in new launches and better raw material costs in a few of our key products.
Within our base business, the gross margin in Q4 FY 2025 was at 61% compared to 56% in the previous year. On a full-year basis as well, the gross margin has improved by 100 basis points as compared to previous year. Our net profit for the fourth quarter increased by 3% to INR 1,865 million compared to Q4 FY 2024 and declined by 10% in the full year as compared to previous year. During the quarter, we achieved a PAT margin of 13%, consistent with the previous year. For the full fiscal year, our PAT was INR 6,985 million, resulting in a margin of 12%. Other income, which is mainly interest earned from bank deposits and foreign exchange gains, amounted to INR 440 million in Q4 FY 2025, is lower than as compared to INR 585 million of Q3 FY 2025, primarily due to reversal of foreign exchange gain during the quarter.
For FY 2025, other income was INR 2,136 million, which has increased as compared to INR 1,702 million in previous year due to increase in interest income. Higher finance costs incurred during the year are related to interest charges and a GST-refund matter. Total R&D expenses for the fourth quarter were INR 503 million compared to INR 437 million for the same period of the previous fiscal year, representing 4.9% of revenue from operations on an ex-Cenexi basis. For the full fiscal year, total R&D expenditure was INR 1,922 million, which constituted 4.7% of our revenue and increased from last year's 4.3%, underscoring our ongoing commitment to R&D. On a stand-alone basis, our effective tax rate was 26% in the fourth quarter, and same 26% for the full fiscal year. As of March 31, 2025, at the group level, our total cash and cash equivalents stood at INR 25,562 million.
After accounting for Cenexi's debt, our net cash position was INR 22,870 million. Cash flow from operations during FY 2025 was INR 9,147 million. Working capital as of March 31, 2025, was INR 21,683 million. Our average cash conversion cycle improved to 172 days for the 12 months ending March 2025, compared to 173 days in the corresponding period of the previous fiscal year. Total capex during the quarter amounted to INR 886 million, and full year FY 2025 amounted at INR 3,938 million, allocated to Gland's Indian sites and Cenexi. In India, our growth capex is focused on expanding a new bag line and increasing packing capacity. We are also in the process of adding a new cartridge line at Suite 9, which will complement the existing cartridge line at our Pashamylaram site.
As Alain mentioned, at Cenexi, we are investing in additional high-speed new lines and Lalos to enhance overall capabilities. 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 their touchtone 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 question queue assembles. Again, if you wish to register for a question, please press star then one. Our first question comes from the line of Neha Manpuria from Bank of America. Please go ahead.
Yeah, thanks for taking my question. My first question, just a clarification. What would be the profit share milestone number for the quarter? I seem to have missed that. Hello?
You want the absolute number?
Yes. The profit share and the milestone number, please.
It's about INR 145 crores. It's about 14% profit share. Milestone is 6%.
Okay. Got it. If I look at the U.S. business adjusted for these two, then it seems like we've been in that $70 million to $75 million range per quarter in the U.S. business, despite the fact that we've launched 31 new products in the year. How should I think about growth from the U.S. business as we launch more products and gain more volume in terms of growth? What should this number be next year and the year after? Just an add-on question to the U.S. market, given the noise around tariffs, what are we hearing from our customers in terms of the ability to absorb or cost on that? Thank you.
Yeah. From the U.S. revenue perspective, while there's from the new launches, about 4% growth, which came from U.S. There are also the normally over the years, it's been around 8-10% growth, which used to come from new launches. What happened also was the products, several key products where the material costs have gone down, and the end market price also was reduced, the transfer price. The revenue came down, but the margin was intact. That's one of the reasons why actually the revenue didn't move that much compared to previous years. On the tariff side, it's too early to comment, but what we hear is for generics, it will not impact that much. As well as also, what we see is probably most of it will be passed on if there are any tariffs to levied on Indian ports.
From the US business, I was thinking about from the $70-$75 million that we're doing as of milestone and profit share. What should this number be over the next few years? Will the new launches now be able to reset this base higher, or what should drive this base higher?
Yeah, it should contribute more, looking at the historical numbers and also the type of products which are going to get approval in the next year or two, more from the complex side. Also, we are looking at as a business, we're looking at mid-teens as a growth for the coming year.
This is for the US business or for the consolidated business?
For the consolidated.
Okay. Got it. On the ROW business, it seems like the Saudi contract tender has been delayed for some time. What should drive the growth of the ROW business for us, given that the Saudi contract is not coming? Are there any more drivers for us, or is this the new base that we should be operating, that Gland should be operating at?
Hi, Neha. Yes, you're right. What has also happened is the Saudi NUPCO, of course, we lost the tech transfer going on right now, where we want to re-engage the local partner to manufacture enough of the padding; the volumes will come back. What we are doing also is in place defining a non-Enoxa and non-heparin strategy. We have clearly earmarked some high-growth countries where we have a very portfolio approach, a targeted registration approach, which will help us going forward. We have approximately upwards of around 500 registrations still pending, which will come over years. There are three growth levers here. One is how do we push the current registration?
How do we use our cost efficiency that we have to win tenders in some of the key tender markets? And how do we, again, be a very focused country, in-country kind of strategy? We define and play in the country with a very strong portfolio approach. This quarter, also, what has happened was because of the U.S. volume, we dedicated some capacities to ROW, but we are back on track. That is how we use this quarter. Our long-term vision on ROW is the strongest. We internally have reason to believe that this business can double over the next three to five years.
Got it. Thank you so much.
Thank you. A reminder to all the participants, if you wish to register for a question, please press star then one on your touchstone phone. Our next question comes from the line of Bino Pathi parampil from Elara Capital. Please go ahead.
Hi. Good evening. Just a follow-up. Did I hear right that you said next year you are looking at mid-teens growth at the overall level?
That's correct.
Okay. That is including Cenexi?
Yeah.
The consolidated revenue? Okay.
That's correct. Yes.
Okay. Got it. Apart from the improvement in Cenexi margins, are you looking at improvement in margins in the rest of the business as well?
The rest of the business actually has been pretty good. I mean, it stabilized around 37%-38%, which we have seen last two quarters. We continue to maintain around that margin for us.
Got it. From your presentation, I can see that you have 27 Para 4 filings in the U.S. Out of which, how many would be of any first-to-file exclusivity?
Give me a second. We can come back to you on that, you know, to give you precise data.
Sure, sir . And more, I'm looking at any big exclusivity launch expected in the next couple of years, 2026 or 2027, as a financial year?
Yeah. We'll come back to you on that. Yeah.
Okay. Perfect. Thank you.
Our next question comes from the line of Ashish from Everflow Partners. Please go ahead.
Good evening to the management. My first question is, what sort of growth could the GLP drug be for us in the coming year and over the next two, three years? Would they meaningfully accelerate our growth trajectory?
So GLP right now, our position is around 40 million cartridges. Next year, we will be one of the top-tier cartridge capacity companies with 140 million. Now, GLP, as you know, in many markets, is going off -patent . This is really a fill-and-finish opportunity that we are looking at. Our initial success is giving us all the strength to go further and block all the capacities in the coming time. How the market will behave on the demand side, on the patient pricing side, is something that partners would answer. There is only encouragement. There is only good news around GLP. The volumes are the kind of volumes the partners are discussing are very, very high. We feel that this market will explode by volumes, at least, in coming years.
Right. Could you please quantify the growth in the next two, three years, given the product pipeline and base business?
Ask again.
Could you please quantify the growth? Yes, sir. Could you please quantify the growth over the next two, three years for our business, given the product pipeline and base business?
Next year, we set about mid-teens. Subsequent few years, maybe two years, it will be low 20.
Okay. Got it. Yes, sir. Thank you. That's all from my side.
Thank you. Participants, you may press star then one to ask a question. Our next question comes from the line of Adityap al from MSA Capital Partners. Please go ahead.
Hello. Am I audible?
Yeah. Go ahead.
Thank you so much for the opportunity. Just wanted to quickly understand the thought process on Cenexi. What I can understand is Cenexi is largely a Generic CDMO business. I am not understanding why the employee benefit expenses are 60-65% of my revenue. Have we over-invested in people where now that we scale up from here, the margins will flow directly to the bottom line? That is question one from my side.
Yeah. So yeah, the average cost of manpower in Europe is around EUR 40. So comparatively, a bit more higher at Cenexi. I think that's the issue where we need to address. It's also related to how much revenue we are getting and how efficiently we can manufacture there. With the investments we're making on the CapEx, we are installing more efficient lines. That will give us a large throughput. At least two sites have demand which is more than what we're able to supply today. With the new lines which are adding up, that should cover the revenue loss we're having today. From the strategy perspective, if you see, these are branded generics is one, the solid business. If you look at the customer base and the volume base what we have, it's been very consistent over many years. That's the nature of the business.
Second, also technology is what Gland do not have. They do have. They do make changes for oncology products. They also have hormonal products. They do vaccines and some biologic products as well. From technology perspective, they have additional things. That's the logic we have at that time. Of course, there is also some business in the U.S., which is most of the business was in the U.S. To enter Europe, we need to have this kind of a business. There are several reasons on why we acquired it. Yeah, from efficiency perspective, that's where we are focusing right currently because, like you rightly said, the manpower cost as a percentage to revenue is quite high compared to the other companies in Europe.
A couple of questions which are interlinked with each other. In your presentation, you said that we are planning to spend close to EUR 60 million over the next three years in Cenexi. One is that when will we achieve a double-digit EBITDA margin in this business, that is Cenexi? What will be the ROCE of this business? Because if we are investing EUR 60 million over the next three years, and the base business can do a 25-26% ROCE comfortably, and if we are not able to achieve that, then it does not make sense to judiciously use the cash flows in investing for a Gland-based business. That is the thought process that I want to understand from the management.
Yeah. So basically, this CapEx is an investment for the long term, and we are increasing the capability and capacity. We have sufficient visibility of the pipeline and the business interest. There is a strong funnel we have with the customers. We will be spending this money next two to three years in building, like Alain mentioned, and we spoke about it, is one is, of course, adding a new pre-filled syringe line in HSC, which will entail a much better realization per unit sale than what currently we do. In the Belgium side, we are adding one additional wire line and Lyos that will significantly improve the capacity of high-value business. There is already tied up in the business and contracts for that. We are looking at a break-even in this December quarter. Next year, we should improve the EBITDA margin significantly.
There's a high operating leverage there. We should be getting reaching almost the earlier double-digit EBITDA in the next year after that.
Understood. Just one last question from my side. To the early participant, you mentioned that we are aiming to grow at mid-teen growth for the entire business. How should one look at it from an overhead perspective? Do we see the overhead, that is what the Cenexi and the base business is, increasing in lockstep with the revenue growth, or is there some room for operating leverage now?
There's ample room for operating leverage. Like you're mentioning, the overhead in typically injectable capacity is about 80% or more fixed. The workforce which we have currently is sufficient to take care of the additional line we are adding. We are not going to hire new people for that. It is inside the same facility. The electricity and other overhead will remain the same. As and when the revenue ramps up, we would see the margin expanding.
Understood. Understood. Thank you so much, and wishing the team all the very best.
Thank you. The next question comes from the line of Tushar Manudhane from Motilal Oswal Financial Services. Please go ahead.
Yeah. Thanks for the opportunity, sir. Out of that pre-anticipated approval from the in-house complex pipeline, could you just share the market size and, let's say, the competition that can come up at the time of launch by Gland without naming the product maybe? Hello?
Yeah. From a pipeline perspective, we have a total of 71 ANDAs in the pipeline with a TAM of around $5.71 billion, of which our GenSy portfolio has around 40 ANDAs, covers a TAM of around $1.24 billion. In the next one to three years, our pipeline, we have five ANDAs with a TAM of around $2.12 billion. Beyond three years, our investment that we are doing with co-development partners, the 505(b)(2), A NDA, we are targeting a TAM of around $2.34 billion market. If you see from an R&D standpoint, we see also 33 launches in the U.S. Our new launches are more gross margin than the average gross margin. For example, we have 72% gross margin only from the new launches as compared to the company average of 58%. Therefore, we are very focused on what to launch going forward.
Yes, we are a manufacturer. From a demand estimate standpoint, we do get forecasts and all from the partner company. We are looking forward for, again, a similar kind of revenue contribution from new launches in the coming year.
Sure. How much would be the contribution from Enoxa and Heparin for fourth quarter and FY 2025 across the geography?
[Audio distortion]
Thank you.
About 15%? 14%, yeah.
14% for the quarter as well as FY 2025?
14% of the total revenue.
Yeah. For the quarter as well as FY 2025?
FY 2025 is about 14%. The quarter is about 16%.
Secondly, this milestone as well as share if you see last couple of quarters, the quantum has increased on absolute basis as well. While it's difficult to predict per se, but how to think about this maybe for next few months, are there any good products which can still sustain such kind of income for us?
The milestone actually last quarter is lower than before because it's not consistent on a quarter-on-quarter. It depends on what milestone we hit in that particular quarter. Some are timing milestones and some are when we hit filing or if it's a debt transfer, then it is closed executive process. The timing will be different, but overall, annual basis if you see, it's more consistent. I would say milestones are looked at on a yearly basis. For profit share, it depends on how many launches we have done and how it has increased. If you see the launches what we have done in Q3 were more, almost I think 13 products we launched in Q3. That will contribute to higher profit. That's the reason why we got a higher profit share in Q4.
What is the GLP that is also contributing to this milestone income or profit share?
No. No. No. It's nothing to do with GLP. It's not usual.
Understood. Just lastly on this biologics, while one contract is expected to sort of start revenue in FY 2026, broadly, if you could share how much overall we can expect in FY 2026, is it like $25 million-$30 million to start with in biologic business, or will it be still a gradual scale-up in this segment?
Yeah. For FY 2026, it will be about INR 100 crores, I would say. I think that will increase.
Understood, sir. Thank you. That's it for me.
Thank you. My next question comes from the line of Shyam Srinivasan from Goldman Sachs. Please go ahead.
Yeah. Good evening. Thank you for taking my question. Sir, when I look at the overall US revenue, annually around INR 3,000 crore, $350 million. And I'm just trying to tie it up with the growth guidance. We need to, at least US needs to grow at least 15% given the size. We're looking at an additional $50 million of revenue. I just want to understand how is 2026 different from 2025? I thought we had a similar ambition to grow. Clearly, the launch track record has been very strong. Is that what is going to be driving this 15% growth in the US, which we have not seen so far, but maybe it comes in 2026? What gives us that comfort on guidance?
FY 2026, overall, we are seeing 15% growth. It is a combination of some growth coming from Cenexi because the numbers will improve that. The early thing that is last quarter. Some growth will come from there. Some growth will come from the new launches. Some is the tech transfer project what we started. Some dry powder contracts what we have done that contributes about INR 60-70 crore. Yeah, about INR 60-70 crore from that. Then the biologics will contribute around INR 100 crore. There are different levers which are contributing to this combination of. Also, if you see our volume growth in the U.S. is substantial. While the prices have come down because of the overall material cost, the top 10 has kind of from the transfer price wise, it is stabilized. Now the volumes have gone up.
Even if you look at our top 10 products, that has actually grown around 24% in terms of volumes. There is a lot of uptake in terms of our top products, especially even if you consider Heparin and Enoxa, not just these two, but there are several products where we got some newer contracts. Added to that, what is happening is what we have invested into the line time and also some of the R&D investment which has gone into lifecycle management of products that has helped to reduce our cost. That made us more competitive. That is the reason why our volumes have increased. Also, while the prices have come down, still we are able to maintain that EBITDA margin. That kind of consumes some of our line time, which has actually what we call mitigated some of our business growth in R&W.
That will also now come back because we have new three lines added this year. That will be coming up to add in. Yeah.
Helpful, sir. Despite all this volume growth, I think pricing or whatever transfer pricing related pressure has been high. How would you quantify that for, say, fiscal 2025? What gives us the confidence that pricing will not even worsen in 2026?
When I say the enterprises have not changed, what we said is the transfer price has gone down because we have reduced our material costs and changed our suppliers to be more competitive in the market. So we get more contracts. That's why the volumes have increased. At the same time, we're able to maintain margins.
Understood, sir. Thank you and all the best. Thank you.
Thank you. The next question comes from the line of Dheeresh Pathak from WhiteOak. Please go ahead.
Yes. Thank you. Sir, how much have you spent on that $100 million pen line?
100 million. This cartridge line is due to be installed this year. The overall cost would be about INR 120 crore, everything together, only for this cartridge.
120 crore. Okay. Does Cenexi also have cartridge lines?
No. Only syringe lines. No cartridge. The syringe lines can also handle the cartridges, but restricted to sterile cartridges. They cannot do bulk cartridges.
Restricted to?
Yeah. The syringe tub lines can be used to fill sterile cartridges. Not the bulk.
Yeah. Okay. Sir, just on Cenexi, so we paid EUR 330 million. Then we are spending another EUR 60 million to enhance the capacity, then another EUR 30-40 million in loss funding. We end up spending EUR 315 million. Even if we do EUR 200 million revenue, double-digit EBITDA, barely making. I mean, if you add on that tax and maintenance capex, this looks like a very, even if we get to that milestone of double-digit, how much we have spent and the bandwidth and all that it has taken seems like a very poor capital allocation. Is this a business even worth pursuing based on whatever, obviously, benefit of hindsight and whatever your understanding with currency? Is it a business worth pursuing?
The investment phases are taking longer than what we estimated, for sure. Now that we are back on track, with this additional capacity which we are adding to this CapEx, this will take our revenue to not $200 million, but $300 million in three years' time. We are looking at EBITDA of about 18% as a percentage. There is also a strategic lever, which we have not yet been able to get the benefit out of simply because we are currently focusing on getting the things housed in order. For example, we are looking at cross-selling to each of these customers. We have not looked at that aggressively yet.
If you look at the customer base of Cenexi, they have big 3M players whom actually we do not have access to. Also, these players also sell in reservoir markets.
They are looking at increasing that market, getting products out of India. There are a lot of other benefits we looked at when we invested into the CapEx. Currently, the focus is on making it a bit more efficient to get that on track and then work on the synergies because there are too many things we cannot do at the same time. From a long-term perspective, there are other phases, and we are still there. There are several opportunities where we can use this. Like I said, the controlled substances, we cannot make it from India and sell in the U.S. There are very few players who supply those products. Europe can supply. They also manufacture a few products to other players who supply to the U.S. market. We actually are restricted in that.
The idea was we can actually develop some products in India and then transfer there and supply to the U.S. in terms of control substances. There are several other areas of synergies what we looked at when we acquired the CapEx.
Yeah. Limited point, sir, is that even at 300, at 18, it will not be the best of return on capital investment. It just looks like that doing this kind of a CDMO work in Europe is, I mean, assuming that when we get to 18, we would be among, in terms of operating efficiencies, in terms of top quartile in the European assets. With this kind of an asset price, at least doing this kind of a business in Europe does not look as attractive unless you're saying that we can scale up even much higher than this. That's my limited point. I'll leave it at that. Thank you so much for clearing.
Thank you. Our next question comes from the line of Harsh Bhatia from Bandhan Mutual Funds. Please go ahead.
Yeah. Thank you. Am I audible?
Yes. Please go ahead.
Sir, thank you. Two quick questions. One is in sort of relation to what coming to me earlier. In terms of the capacity expansion, again, related to the Cenexi part, multiple line items and expansions, including add-builds and liabilities. Is there a situation right now where we are not able to take incremental business because of high level of capacity utilization or some other reason, which is why we are going so aggressively for this capacity expansion plan? I mean, I'm just trying to sort of piece together?
Yeah. At least two sites, I think we are not able to cater to the demand because of, I would say, slower lines or inefficient lines, I would call. Of course, one is replacing the current lines in one of the sites. The other is adding new capacities because of the demand for Lyo products. One is for the current products we have commercialized and also the pipeline we have. Moving forward, Lyo, as you know, contributes more in terms of margin. We need to invest into those. That is the reason why we have made these investments or are making these investments.
Sure. What would be the order book looking like for Cenexi as such?
I had to come back to you. Yeah. There was something.
Sure. Lastly, on the cartridge capacity, I mean, one could presume that a lot of that capacity as being sent today is at the 40 million level. Possibly, the incremental 100 million, a lot of that would already be booked to that extent. In terms of the pricing part, if you could show some more color as well as is there some element of take or pay because obviously your sales would depend on regulatory approvals depending on market to market. Obviously, you will not be able to, you will not be selling based on where the client is selling. Irrespective, maybe some points on the pricing part as well as the take or pay and the regulatory aspect.
is more a fill and finish CMO kind of job. We are speaking to four kinds of customers: Indian players who want to launch their GLP in global market, Indian players who want to launch their GLP in India market, global player who wants to launch their GLP in India market, and global market. From a fill and finish standpoint, as you arrange, the range is between $1 to $2. That is the range of fill and finish. As we are preserving some capacities to give it to the best partner so that the whole business is sustained, we did the deal with the Indian company for the global market. This is what the sense is.
Sorry, just one last follow-up.
Hello? Yes.
Can you hear me?
Yes, sir.
What did you not hear, Harsh?
Sorry, just one follow-up. Lastly, my best partner, you mean a customer who is able to give you good visibility in terms of the volumes and capacity bulk up. That would be the right term?
Exactly. Customer who has a strong presence in that country of law and a customer who is very serious about making this able to start up in that country.
You could say for the next one to two-year period, let's say very broadly put, maybe at the India level or at a global level, there could be certain supply constraints in terms of fill and finish with the cartridge capacity as well as the pen assembly. Maybe these two components would have some level of supply constraints at the India level or at the global level?
It depends on how this market plays up. Time will tell how Sema will, for example, one of the proprietary companies has launched Sema in a vial, their GLP i n India. Okay? It really depends on how this market plays up. Yeah. The volumes are increasing. The volumes are increasing. We are getting prepared. We have to say at 140 million, as I told you earlier, we will be one of the top-tier cartridge capacity companies in the country. There was a question around order book of Cenexi. It is around EUR 100 million.
Sure, sir. Thank you.
Thank you. Our next question comes from the line of Alankar Garude from Kotak Institutional Equities. Please go ahead.
All right. Thank you for the opportunity. Firstly, with the two contracts on GLP-1, how much of the 40 million capacity is booked out?
No. Most of it will be consumed. That is the reason why we have invested in the second line because I think it will be in a phased manner in the next few years. The second line will be up and running by the end of this year. EUR 40 million will not be enough for the new partnerships we are going to enter.
Got it, sir. So you spoke about this $1 to $2 for the CMO fill and finish on the pricing front. Is there any annual repricing clause?
Yeah. It's always on the contracts, it will be there depending on the cost structures and all that. Yeah. It's always there. Also, there will be, especially the CMO, there are two types, right? One is, of course, the tech transfer that happens in product or the pure CMO. Pure CMO always have these clauses based on the volumes. The pickups are in volumes, there will be pricing, and lower volumes, there will be higher pricing. There is a clear pricing.
Understood. The second question, you mentioned about passing on most of the tariffs to your clients. Have you had any conversations with your clients on this front, and what has been the initial feedback?
There is no real concern from our partners because if you really see the tariffs is on the transfer price, not on the end price. The impact will be lesser. There are a couple of conversations, but it was very clear that it will be passed on.
Got it. And one final clarification. Did you mention double-digit EBITDA margin in Cenexi in FY 2027 or FY 2028?
2027.
Understood, sir. I'll write it from my side. Thank you.
Thank you. Ladies and gentlemen, with the interesting time, we will be taking one last question from the line of Mr. Vivek Agarwal from Citig roup. Please go ahead.
Thanks for the opportunity. My question is on the U.S. business. This year in FY 2025, overall growth was almost flat. Is it possible for you to give some color on how the existing products have done as far as the volume growth is concerned as well as the new launches and how the pricing has behaved?
Yeah. So Vivek, as I told you, in the U.S. FY 2025, the volume growth has been plus 9%. The price has been minus 5%. On the new product front, for the full year, the new launches in the U.S. contributed to 6% of the overall revenue. The new product gross margin is 72% for the full year. Yes, these are data that is done on the U.S.
Understood. For the next year, right, you are giving a kind of mid-teen kind of growth at the consolidated level. How to look at growth in the U.S.? I think you need to fire in the U.S. in order to achieve that kind of growth is what is my understanding. For example, is it the other markets you are taking up higher growth? Thank you.
If you see, Vivek, the U.S. market, our top 10 molecule revenue will be by 26%. We are really preserving our top business in many ways. It has grown in the function of new launches, new approvals that will come on an average. We launched 33 products this year, and we intend to continue that momentum in the coming years. It will be a combination of new customer acquisition, and it will be a combination of new customer acquisition plus value expansion with new ANDAs and all of that with the existing customers. U.S., the estimate is next year, 18%, 12% on the products and 6% on the CMO projects to the US. It's about 18%.
Understood. That is quite good. Lastly, actually, to answer. Going into content in the U.S., is it still there on the platter or has the plan been dropped?
Still evaluating. I mean, like you said, everybody is paused. We are looking at how this tariff thing works out and how it's going to impact and all that. It is not off the platter yet. We're still looking at it.
Thank you, sir. All the best.
Yeah. Thank you. Thank you. Ladies and gentlemen, we will take that as the last question. I will now hand the conference over to Ms. Runjhun Jain for closing comments.
Thank you, everyone, for joining us today. We truly appreciate your insightful questions and engagement throughout the session. Should any further questions arise, please do not hesitate to reach out to us through our investor relation team. We look forward to connecting with you again next quarter. Thank you.
Thank you. On behalf of [crosstalk].
Yes.
On behalf of Gland Pharma, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.