OneSource Specialty Pharma Limited (NSE:ONESOURCE)
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Sep 11, 2026, 3:30 PM IST
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Q3 25/26

Jan 23, 2026

Summary

Q3 FY 2026 saw a 26% revenue decline due to regulatory delays in Canada, impacting EBITDA and PAT. Despite near-term softness, robust demand, capacity expansion, and strong customer partnerships support confidence in achieving FY 2028 guidance of $400M revenue and $160M EBITDA.

Operator

Ladies and gentlemen, good morning and welcome to the OneSource Specialty Pharma Limited Q3 FY 2026 earnings conference call. As a reminder, all participant lines will be in the listen only mode and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during this 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 Mr. Abhishek Singhal from OneSource Specialty Pharma Limited. Thank you and over to you, sir.

Abhishek Singhal
Investor Relations, OneSource Specialty Pharma Limited

Thank you, moderator. Good morning, everyone, thank you for joining us today for the earnings conference call of OneSource Specialty Pharma Limited for third quarter of financial year 2026. We are pleased to have with us Arun, Founder and Non-Executive Chairperson, Neeraj, CEO and MD, and Anurag, CFO of the company who will walk you through the key business and financial highlights of the quarter.

I trust you've had the opportunity to review our results release and the quarterly investor presentation, both of which are available on our website as well as stock exchange website. The transcript for this call will be posted on the company's website within the next week. Please note that today's discussion may contain forward-looking statements, which should be viewed in context of the risks inherent in our business. Should you have any further questions after this call, our investor relation team will be happy to assist you. I now hand over the call to Arun for his opening remarks.

Arun Kumar
Founder and Non-Executive Chairperson, OneSource Specialty Pharma Limited

Thank you, Abhishek. Good morning, everybody, thank you for joining this call on a Saturday morning, especially in a long weekend. We had our board meeting with several of our directors on a virtual basis yesterday, we could only announce results late in the night and therefore we appreciate your time today. Before I hand over the call to Neeraj and Anurag to discuss further on our results, I would just like to set the context of today's discussions in terms of our numbers and how we see the business evolving. Firstly, I would like everybody to draw your attention to my Q4 FY 2025 commentary where I had highlighted that FY 2026 is a transitory year, where our primary focus will be to build readiness in our operating capacity, executing our MSAs and preparing for scale.

All of these key milestones have been achieved and we continue to invest on this singular focus. Our Q3 FY 2026 results have been impacted by revenues being deferred. As all of you know, our DDCs have a major fill-up to our numbers and our FY 2028 outlooks. Having said that, the only large market that was available to operate at scale was Canada between January and end of March when other markets opened. Consequent to several of our partners having not received the Canadian approval for semaglutide we have had a scenario where we had to defer our revenues until that event happens. While I'll get into more details of the Canadian regulatory approval and our view on that, I would like to reiterate our FY 2028 guidance.

At the time of our listing in January 2025, the singular guidance that we have provided to investors is a number of $400 million with an EBITDA of $160 million for FY 2028. This obviously does not include any of the inorganics accretions that we have announced later. We remain extremely confident on our ability to achieve these targets and I will explain why we believe so. Let's get into the elephant in the room which is of course the Canadian regulatory approvals. We have several partners for the Canadian business and, of course, some of you are aware of the public statements that one of our key partners have made about their partnership with us. This obviously refers to one of our anchor partners which is Dr. Reddy's. They were expecting an approval for this product at market opening, which was in January.

This has since been deferred as they had received certain requests for additional information from the regulatory agency. We believe, and based on their guidance that their approvals are slated anytime between now and May. We also believe that other filers from our facility for the Canadian market will be in that range a little later. Consequently, we believe it may not be prudent to build a near-term guidance on these assumptions and we'd rather wait for these events to unfold before we can give better clarity on how the DDC businesses for the Canadian market operates. Having said that, many of our partners have received approvals for the Indian market.

Towards the last week of March those opportunities open up and while India is a market that we can immediately commercialize, obviously we believe that the competitive intensity for the Indian market is severe and it is not a market of focus for us. Having said that, you will find our products at market opening in the Indian market through our partners. Several of the other markets that are opening up in the emerging markets outside of Canada, the only other markets are the emerging markets where over between 80-100 countries open up around the end of March. Many of these countries, the regulatory process is dependent on what we are able to provide as a document called COPP, which is Indian Government Certificate of Pharmaceutical Product, which is only available after a product is launched in India.

We expect to have these certifications in the first few days of April, after which we expect a flurry of approvals for several of our partners in emerging markets, and there are very significant emerging markets that will add up to the volumes. I will now come to the capacity prioritization. We could have continued to accept MSAs from new customers, but we decided to prioritize our capacities for our commercial sales, considering that we have contractual obligations, but also we obviously make more economics when we move from MSAs to commercials. Accordingly, until we have all these approvals in place, we expect the next two quarters to remain relatively soft.

Having said that, our aggressive CapEx of over INR 700 crore to increase capacities are progressing very well, and we believe that by H2 FY 2027, we will have significant additional capacities that will come up for increased demand as we see. As we see, most of our customers have started increasing their forecasts, and we strongly are now very confident that we'll be able to meet an increased outlook. Another factor that we are confronting and working with our partners is the current batch size and the scale-up. The current batch size, because the high cost of development of most of our partners are suboptimal, and in many cases, not very commercially viable when you want to run very large production runs.

We are working very actively with our partners to scale up capacities, but these involve scale-up batch sizes to meet our increased capacity so that we can be more efficient and cost competitive for our partners to be more competitive in their market space. We are working with several of our partners, and we are in the process of concluding those activities and getting regulatory approvals in several markets such that we can increase our scale. In hindsight, these approval-related uncertainties have played out as we have anticipated, reinforcing our decision not to provide an FY 2026 or 2027 guidance and pivoting our guidance to FY 2028, which we now continue to reiterate.

The negative operating leverage that we expect now in H2 of FY 2026 and partially in H1 of FY 2027 reflects the absence of new MSAs due to strategic priorities and the fact that commercial supplies have not yet commenced. Notwithstanding these near-term factors, our confidence in the DDC opportunity remains high. Customer forecasts continue to be revised upwards. There's not one customer who has not revised forecast upwards. FY 2027 will mark the beginning of material CSA revenues, with H2 significantly stronger than H1. We expect our Q4 FY 2027 annualized exit run rate for both revenues and EBITDA to be a good reflection of a near close FY 2028 guidance numbers. You will appreciate that many of these actions we are dependent on our partners.

While our partnership philosophy is strong, we are working strongly with these partners to work to get the maximum outcome for both them and for us. All of this makes business sense for us to reprioritize. Another operational highlight before I pass on the conversations to Neeraj and Anurag is an update regarding our sterile facility in Bangalore. You will appreciate that this facility is approximately 20 years old since it has got several FDA inspections, including a stellar recent inspection. However, we are converting a large part of this capacity to include increased demand in specialty injectables like long-acting injectables, high-viscosity pre-filled syringes. We are taking a four-month shutdown where we will significantly increase our capacities in lyophilization, pre-filled syringes, high-viscosity pre-filled syringes, and also other capabilities. Consequently, this will have a near-term impact.

This is not going to be a material near-term impact, I thought it is important we use this occasion to also bring this up to your notice. The last point that I wanted to discuss in today's call was a business decision that we have taken as a company. We now have little over 30 new customers that we have added in the last three years since the formation of Stelis and then eventually OneSource. We currently hold approximately INR 250 crores as advances from customers who pre-book our capacities. It is, in normal circumstances, very easy for us to enforce our take-or-pay contracts.

Considering that some of our partners have got delayed approvals, considering that our partners have increasing batch sizes, increasing their contract tenure with us, in many cases, we are now working with our partners to be proactive and find solutions where both partner and us benefit. Consequently, in some cases, we have either deferred our take-or-pay contracts while we continue to receive significant advances from our customers. This is very important for us as we have managed, in most cases, to extend the contractual obligations of our partners. Where we haven't, we obviously are now evoking the take-or-pay contractual obligations. With this, I'll let Neeraj to discuss the rest of the call, then I will, of course, be available if you have any specific questions to my opening comments. Thank you.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Thank you, Arun, good morning, welcome everyone to our Q3 results. As Arun mentioned, this quarter's performance has broadly been shaped by the semaglutide approval delays for our customers in Canada. As the transition from MSAs to CSAs has been pushed out, as a deliberate choice, we did not take new DDC MSAs purely strategically. As a result, the Q3 revenue declined by almost $10 million versus the previous quarter. Considering the nature of our business, the revenue shortfall resulted in a very unfavorable operating leverage and thus the EBITDA declined by more or less the same amount. While the revenue trajectory got impacted during the quarter, what is really heartening for us, and it should be also for our investors, is that the underlying demand of our business remains absolutely robust.

Our order books continue to expand, this is for customers in Canada, India, rest of the world markets, which are all opening up for semaglutide in this quarter. Both ourselves and our customers, we continue to believe that our customers will certainly be among the first movers across all these markets, notwithstanding the delays, and this includes the Canadian market. Once the approvals are received over the next couple of quarters and the commercial supplies start, we are absolutely confident that the incremental revenue, which is coming, will flow meaningfully through to the bottom line. This is that our capacity expansion plans remain absolutely on track. As of last month, we have already committed almost three-quarters of our total planned $ 100 million CapEx investment spend, which we have set for our flagship site. Obviously, we also continue to man and to run these lines.

We are expanding our workforce and in our flagship site in year-to-date, we have doubled our workforce by adding almost 300 new FTEs. Overall, we obviously remain very positive about the GLP-1 opportunity, and while we expect the approvals to be staggered over the next couple of quarters, there will be a very, very significant commercial uplift starting in FY 2027. Going beyond drug device combinations, we have also made notable progress across all other service offerings. In fact, we are most excited about our nascent biologics business, which has benefited from some very strong tailwinds, both from the new FDA guidelines on biosimilars as well as the passage of the BIOSECURE Act in the U.S. As a result our RFP today are almost 4x of what they were at the end of last year. Our funnel is at absolute historic highs.

Also happy to share that during the quarter, we onboarded yet another global biosimilar customer. This is a U.S.-based biosimilar major, and at the same time active discussions ongoing with multiple European players. Our customer engagement seems high. The teams are out in the market meeting customers, and also there have been a significant increase in the customer visits to our sites in this year. Beyond biologics also, we continue to add customers, even during the quarter, in our injectables and soft gelatin business. The whole founding philosophy of OneSource, which was the integrated one solution offering and cross-selling, is resonating very well with the customers. In fact, in our soft gelatin business, we have, in the last quarter, secured approval for our first oncology asset. This is a new way. We never had oncology product. Now we got approval for oncology asset, and this is an NDA.

Happy to also tell you that it has been partnered with one of the top 10 U.S. generic companies, which really adds to our specialty offering. Also in our injectable business, our customers continue to gain share and for both our existing products as well as adding new projects into the pipeline. Along with the business, when it comes to operations also, our execution remains robust and I'm extremely proud of the fact that our quality record and the compliance record remains stellar. Year-to-date, we have had 36 inspections, both from regulators as well as our customers. In fact, also delighted to say that yesterday at our flagship DDC site, we have a very good inspection. We will keep you informed on how this continues to advance.

As a very responsible global CDMO, we continue to advance our sustainability agenda, earning actually a EcoVadis bronze medal this year, and a very meaningful increase across all the categories which were there. To conclude, what I would say that despite the near-term timing effect and the approval hiccups, our customer orders continue to strengthen, our capacity build-out remains on track, and our commercial readiness is very high, which is really helping us to reiterate our FY 2028 guidance which we have given of becoming a $400 million revenue company organically. We are absolutely confident of achieving this through execution across all our service offerings. As we continue to build OneSource, I really want to thank our teams for their dedication and our customers for their collaboration. Thank you very much. I will hand over to Anurag, who will share with you details on the financial performance.

Anurag Bhagania
CFO, OneSource Specialty Pharma Limited

Thank you, Neeraj, and a very warm welcome to everyone joining us on this Saturday morning. I will now present to you key financial highlights for the third quarter of FY 2026. As Neeraj already mentioned, and Arun also spoke about it, our quarter performance has been largely impacted because of the delays on customer approvals in Canada. As a result, the reported revenue is about INR 2,903 million, which is a 26% year-over-year decline. The shortfall in revenue, combined by our fixed cost base, resulted in an EBITDA of INR 173 million. Adjusted PAT stands at a loss of INR 472 million, and adjusted EPS on a diluted basis is a negative INR 4.1 per share. As you all know, during the quarter, there has been a regulatory change related to the Code on Wages.

As is prudent and appropriate, we have fully provided for the impact of this change as an exceptional item in our financials. Our PAT and EPS exclude exceptional items which are related to scheme intangibles. I would also like to highlight that the balance sheet includes goodwill arising from the scheme of arrangement that we had last year, which reflects the strategic value in that transaction. The goodwill is a non-cash item and has no bearing on our operating performance and cash flow. On the working capital trends, it reflects a planned inventory build-up for significant launches that are upcoming on the semaglutide launches. These are all temporary and timing related, and we expect it to normalize over the course of time gradually over FY 2027. These inventory buildups are customer-backed, either with advances or firm purchase orders, and largely expected to normalize during the course of time.

On the treasury side, we've got some very exciting developments during the course of the year. We've had two-notch upgrades, two rating upgrades, leading up to four-notch upgrades on our credit rating. All of that is now starting to show up on the decrease in interest cost, and we are very happy to announce that we are now 200 basis points lower versus last year, less than 9% effective interest rate. We've made significant arrangements to ensure that our CapEx plans are fully funded. We've tied up with strong relationships across global international leading bankers, including very significant partnerships with local Indian bankers. We see that for a short term, the CapEx funding led increase on the net debt. However, we are very confident of the near-term guidance of less than 1.5x of EBITDA as our net borrowing.

We remain confident about the fundamentals of our business and very strongly building the future of our business, remaining committed to the shareholder value that we want to create. I thank you all once again and look forward to your continued partnership.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

We are good to open for Q&A.

Operator

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 telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants, you are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Abdulkader Puranwala from ICICI Securities. Please go ahead.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Yeah. Hi. Morning to you, and thanks for the detailed explanation and outlook for the business. Just my first question is with regards to this plant shutdown. First, was there any impact in this quarter as well? And is it the same DDC plant where you're planning to expand your capacities for injectables?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Abdulkader, this is Neeraj here. Abdulkader, this is not the flagship DDC site. That expansion plan there was absolutely on track. The plant Arun was referring to was the general injectable site, which is in Bangalore. That is the site which is one of the oldest sites in the group, where we supply general injectables. That is the site where we are adding capacities in localization, we are adding some new capabilities, and that is the site where we would need to take a shutdown. Our flagship site, obviously, there is absolutely no shutdown there in the flagship DDC site. The expansion which I mentioned, we already committed almost $75 million in that expansion.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Got it, sir. Second is on the quarterly numbers. Just trying to understand the quarter performance. The INR 290 crore of revenue, what is posted in Q3, is it a fair reflection of your softgel and injectable business?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yes. The gap, as we said, the decline or the shortfall, let us say, in the revenue is primarily from the DDC business. Because as we know that the DDC business has a very significant EBITDA margin, and the delta there flows down to the bottom line, and that is what is coming to the bottom line. To answer your question, yes, it is a fair reflection.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Okay. Last one from my end. When we talk about the working capital being higher because of the inventory pileup of semaglutide, what is the color we have from our customers? Because we are sitting on some advances as well as on the inventory. If you could highlight what happens if the launch gets delayed beyond whatever timeline we are currently thinking about.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Abdulkader, as we are a CDMO, as you imagine, whatever inventory comes to us from our customers, it belongs to the customers. Obviously, we have all the procurement has been done in conjunction, in agreement with the customers. The delays are actually all on their side. As a CDMO, all inventory risk, if that's your question, actually belongs to the customers.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Understood, sir. No more questions for the moment. Thank you.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Thank you, Abdulkader.

Operator

Thank you. A reminder to all the participants, you may press star and one to ask a question. We have the next question from the line of Rupesh Tatiya from Long Equity Partners. Please go ahead.

Rupesh Tatiya
Analyst, Long Equity Partners

Hello, sir. Thank you. Thank you for the opportunity. My first question, sir, is to understand the peak capacity utilization. I think in the last call you said that, let's say on the 40 million base DDC capacity, peak production can only be 20 million-25 million devices. That seems a little low to me. Any technical explanation you can give for this? Maybe you can also tie this with the batch size increases that we are looking at. Batch sizes, I always thought was an API. It was using API parlance, pardon my ignorance. What are we trying to do there also with these increasing batch sizes? What will happen to the capacity and the capacity utilization?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Rupesh, how I can explain to you is in the following way. Yes, you're right that the 40 million cartridge, that's the headline capacity. One way to look at it is the headline capacity of the line. The second way to look at it also is the number of days which are available in a site to produce that, right? How it works in any manufacturing, especially in sterile injectable manufacturing, we always work on number of days. It's also that the days taken between MSAs and CSAs are different. When we run commercial campaigns, we can do, for example, as many as six batches in seven days. However, when we end up doing MSAs, we end up doing only two batches in seven days. Purely from number of cartridges, it could be, you can imagine, less than a third of the commercial.

We don't always look at the number of cartridges coming out while it is in the MSA phase. As I said earlier in my call, because the MSA-CSA progression has been prolonged. That's why it's not the right time to see the actual number of output. It is number of days which get utilized. That's number one. To your second point on the batch size increase, how it again works, batch size is not just of the API. Batch size is also of the finished product, that's how for you to understand that in one day we make one batch.

If we make a batch of, let's say, 200 liters and a certain quantity comes out in per day, in the same day, if we are able to increase the batch size to 500 liters, the output becomes 2.5 times of that within the same time taken. You can imagine the actual output from the site goes up by that scale. That is the point which Arun mentioned, that requires regulatory approval and in conjunction with our customers, we are working towards that.

Rupesh Tatiya
Analyst, Long Equity Partners

Okay. Just one follow-up, sir. On when we go, let's say, 100% CSA at some point in H2 FY 2027, on this 40 million capacity, the peak production can be 70%-80%. That's a fair assumption.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. In a sterile injectable, that's what typically works. 70%-75% capacity utilization is what we work with. Yes.

Rupesh Tatiya
Analyst, Long Equity Partners

Okay. My second question, sir. Let's say whatever these 20 million-25 million devices we sell, whenever we sell first 25 million, let's say, what would be the rough split between different geographies based on your vantage point? I know your customers obviously will have more information, but based on whatever you have seen the market, looked at the market between, let's say, Canada, India, Brazil, Turkey, Saudi Arabia, ROW. Any rough split you can give just to understand which markets have high volumes?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. Rupesh, that data is the same, which is available to us, is available to you. The fact is that Canada is by far the largest, obviously it's the second-largest semaglutide market in the world after U.S., so that will remain the biggest consumer. At the same time as, approvals come in, as the product becomes available, the market will expand, in all the major markets, whether it is Brazil, Turkey, Saudi Arabia, India, so on. All these will ramp up.

I would only say that, as a CDMO, we will go by our customers' allocation to us. For us, as I mentioned previously, also. We are agnostic whether in terms of pricing or anything else. For us, geography doesn't matter. We supply the product at our factory gate.

Rupesh Tatiya
Analyst, Long Equity Partners

Just this last comment, right? We are geography agnostic, but now I think in the opening comment also, Arun said that India will become severely competitive, and also regulatory barriers are different across the different markets, right? Middle East, India will be a little bit lower, Canada will be higher, Brazil is probably also higher. Do you not see fill finish pricing diverging between the countries based on the regulatory barriers?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Sorry, I didn't get your last point. Fill finish. Again, I think the pricing is really for our customers to work at, Rupesh. As again, I have always maintained, we, A, have the right capacity, B, the right capabilities to support our customers, both in terms of their demand and for them to remain competitive. That's the reason which Arun mentioned and I just explained, for us to expand batch sizes, it helps both the additional capacities and remaining competitive throughout.

Operator

Thank you. A reminder to all the participants, you may press star and one to ask a question. We have the next question from the line of Nitin Agarwal from DAM Capital. Please go ahead.

Nitin Agarwal
Analyst, DAM Capital

Thanks for taking my question. Directionally, what does it do to the business in terms of obviously What is it the business gaining from a more structural perspective when we're relooking at some of these take-or-pay agreements? Just help us understand that a little better.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Nitin, I think Arun mentioned that the customers who we have, and we are fortunate to have the who's who of the generic industry, some of these names are in public domain. What we gain from acting like partners and not like mercenary CDMOs is to really gain a long-term partnership with the customers, to ensure because we know that changes which are there are not because of any inherent gap either in their demand forecast or in their willingness to buy. It is purely based on regulatory delays. That's the reason we are being flexible with some of our key customers, gain their trust, gain their long-term relationship. Having said that's not with all. There are customers with whom we are invoking these clauses strongly and will continue to do as we progress.

Nitin Agarwal
Analyst, DAM Capital

These are the large customers where the flexibility working in. What does it do to the business? Does it mean that you've got more visibility of volumes now at 2028 and beyond? What does it change there?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

We definitely have visibility from customers, in fact, long-term. In fact, beyond three years as well. In fact, the whole idea of this is getting into a much longer-term relationship with them, and that's exactly how it's a double street. We work both ways. We give them flexibility, and we get a much longer-term view from them. In fact, that has been one of the key supporters where we have decided to invest $ 100 million in CapEx. This is all based upon some very strong visibility from the customers.

Nitin Agarwal
Analyst, DAM Capital

Okay. Just following on here on the business. The newer capacities that you are talking about, what are timelines when these capacities incrementally will start to become available for us?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

As we have said, by end of the financial year FY 2027, we would be having almost, installed INR 2000 odd million. These new capacities will be available. As we go along in this year, at regular intervals, the capacity enhancement will be happening.

Nitin Agarwal
Analyst, DAM Capital

What kind of regulatory timeline do you have for post when these facilities are available for them to be commercially available for you to supply to customers?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yes. We have done that work and for most customers, most markets there will not be any new regulatory impact because many of the markets, these are annual reportable kind of changes. There is not likely to be additional regulatory timelines involved here.

Nitin Agarwal
Analyst, DAM Capital

Okay. Secondly, just the last one on this. On the guidance that you put out, we talked about a debt to EBITDA peak guidance of less than 1.5x for FY 2028. Just two questions here. One is, A, in the near term, what is our peak debt that we're expecting given the delays in revenue recognition? Two, I think we had earlier talked about being net cash positive over the forecast period. What sort of changes this outlook here from a guidance perspective?

Arun Kumar
Founder and Non-Executive Chairperson, OneSource Specialty Pharma Limited

Thanks. Nitin, let me try and answer that. On the base business, on a steady state, we expect to be debt-free by 2028. Given our visibility on the biologics, especially on the microbial, we will need to put more CapEx. 1.5x is more a guided number. On the base INR 500 million, INR 200 million EBITDA, we don't expect to have debt on a regular basis. We're just keeping that guidance of 1.5x as more an internal measure, as we believe that there could be more investments in terms of beachheads in the U.S. and Europe, and also an increased capacity build-out in our microbials. It's more a guided number. On the base business steady state, there should be no debt.

Nitin Agarwal
Analyst, DAM Capital

If I can stick, Arun, on the biologics CDMO, there's been a lot of positive commentary in the deck around the progress we've made in biologics CDMO. If you can just help us understand a bit better exactly what is changing and how should we see probably a qualitative sense of the trajectory for this business?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. Nitin, what really is happening, as I said, number of positive things which are happening both at a macro level and obviously which are flowing through at the company level. You may have followed, and everybody has, there's a lot of noise around the final approval of the BIOSECURE Act, which came in, it doesn't matter what the shape or form of the BIOSECURE Act. What it really does is to actually accelerate the entire diversification, the geographical diversification plan for companies. That is resulting in a lot of biotechs, big pharmas, American, Japanese, Europeans looking at India especially OneSource as a probable site for drug substance. Something which is more immediate and near term has been the change in the FDA guidelines on the biosimilar approval timeline. What has happened there is that there's a change in the guidelines.

Most biosimilars do not require now or will not require a clinical trial of phase III. The two things, as a result, the cost of developing a biosimilar has come down from INR 100 million-INR 120 million to INR 30 million-INR 40 million. The timeline from start to finish or to in the market coming down from almost eight, nine years to half of that. All these really are in favor of CDMOs, especially the CDMOs with capacity. As Arun mentioned, microbial capacity, which we are fairly unique in that and ability to offer a very competitive solution to our customers. That has really, these things have really helped increase the funnel of biosimilars which we have.

Nitin Agarwal
Analyst, DAM Capital

Okay. Thank you so much.

Operator

Thank you. We have the next question from the line of Madhav from Fidelity. Please go ahead.

Speaker 9

Hi. Good morning. Thank you so much for your time. I wanted to understand, if the India supplies, for example, for us starts a little bit earlier than Canada, for example, is there a big difference in pricing that we have across different markets? Like if we supply to a customer in Canada versus maybe the same customer in India, does the pricing vary from a OneSource perspective?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Madhav, as I said, thank you for your question. As I said earlier, for us, the market is completely immaterial. Our pricing with our customers is fixed, and it is based upon volume tiers and not on end market. Whether they sell it in Canada or they sell it in India or in Brazil or in Saudi Arabia, our pricing to our customers is the same.

Speaker 9

Okay. Understood. Neeraj, just one more. If you could share any update on how do you see the supply landscape for generic semaglutide evolving? I know this question is asked to you very regularly. Now that we are very close to generic launches globally, how do you see the supply landscape evolving? What kind of market share we could have? I know that you don't need to point estimate. Just very broad thoughts is also helpful just to understand how that shapes up in the next one or two years. Thank you.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Madhav, again, if I answered it at a macro level, we are only seeing the demand continue to actually expand. This is true across markets as the supply, as you have seen, whatever supply improvements have come from Novo have all been taken up, and the volumes have been boosting across markets in a secular way. That is as far as the overall market is concerned. When it comes to supply position, obviously, what we have to be very clear is the regulatory position. It will first is going to be defined by regulatory position. As I mentioned, despite the delays, our customers expect to be in the first wave of approvals, and we and our customers continue to believe that there will be very limited number of players getting approved in a market like Canada.

The supply, obviously the first movers will definitely get a significant share of the opportunity. Overall supply chain, I also want to add that the supply chain overall continued to remain constrained, whether it is in APIs or in cartridges or in devices, and obviously also in the fill finish capacity. It will be a factor of increasing supply as the markets open up. That's how we see it happening.

Speaker 9

No, understood. Appreciate that point. My only question was that, let's say two years later, like DRL obviously is a customer which you all speak about, and then there could be other customers as well. With these customers, do we expect to have a lion's share of their wallet as they ramp up their volumes globally? Or this could be split across two, three, four CDMO vendors. How do you see that sort of evolving in couple of years' time?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

These drug device

Arun Kumar
Founder and Non-Executive Chairperson, OneSource Specialty Pharma Limited

Madhav, let me just answer this. One of the reasons why we keep extending or engaging with our partners for extended period in contract period is when we renegotiate some of, or kind of soften our hard stance on take-or-pay, is when we know our customer is at market formation, will take a significant market share, and that enables us to extend the period of the contract. To answer your point, it's normal that competition in generics would come, and then customers would lose market share. We have to be a position for competitive pricing, which is what we do in terms of pack size increases and stuff like that. Devices, change of devices, the whole nine yards we do in terms of a CDMO typically to make the partner more competitive.

That allows us to sign up longer term contracts because bulk of the work is suggested and done by us, in partnership with our customer. At market formation, it's typical that customers lock in generic companies and buyer universe for a longer period of time. They typically in the more sophisticated markets like Canada and others, will have the first right of refusal to match pricing. It's important for us to align with near term significant upsides to long term consistent CDMO contracts, and that is why we are tweaking and remodeling a little bit of our operating model with our customers.

Speaker 9

All right. Okay. Thank you.

Operator

Thank you. We have the next question from the line of Abhishek Kumar Jain from Alf Accurate. Please go ahead.

Abhishek Kumar Jain
Analyst, AlfAccurate Advisors

Thanks for the opportunity, sir. Sir, my first question on that oral GLP-1. How do you see adoption of the oral GLP-1s by innovators or generics as a trade to the realization rate of this new injectable capacity?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. Abhishek, obviously, this is the oral, actually the obesity has recently been launched. I think we have maintained earlier that orals will definitely have a place in the entire anti-obesity and the diabetes regime. They will certainly have a role to play, especially for the patients who have needle phobia or who cannot take needles. But having said that, thanks to the difference in the efficacy levels and because of the frequency of dosing, daily tablet versus a weekly injection, it is widely expected both by all major analysts as well as, in fact, the companies themselves, both Lilly and Novo, have been very clear in saying that orals will get a share, but no more than a quarter to max a third of the total anti-obesity market. That's at the innovator level. You also mentioned generic.

There is no generic pill going to be available at least for the next eight, nine years because these are recent coming in. It's going to be a significant pattern protection for a very long time.

Operator

Thank you. We have the next question from the line of Sucrit D. Patil from Eyesight Fintrade Private Limited. Please go ahead.

Sucrit D. Patil
Analyst, Eyesight Fintrade Private Limited

Good morning to your team. I have two questions. My first question to Mr. Sharma is, as OneSource expands its specialty formulations and REMS business, how do you see the product mix and capacity utilization evolving over the next two to three quarters? In particularly, how will backward integration, automation in manufacturing, and regulatory compliance process be applied to improve efficiency, reduce cycle time, and strengthen the competitiveness in the global markets? That's my first question. I'll ask my second question after. Thank you.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. I think you already mentioned that we continue to expand and invest in new CapEx. As the commercial approvals come and the volumes ramp up, our supply for drug device combinations will increase and the capacity utilization will move in line with that. We'll keep updating you as and when the new capacities come online. To your question on how we are working on increased productivity, et cetera. I think we are very proud of the fact that we have a legacy and a DNA in sterile injectables going back almost two and a half decades.

In that area, we are really been pioneers in many ways, whether it comes to how to develop sterile injectables, how to manufacture, and we have a team which we are proud of, both in development as well as manufacturing and quality, with a very stellar compliance track record, and we will continue to build on that for our customers.

Sucrit D. Patil
Analyst, Eyesight Fintrade Private Limited

Thank you. My second question to Mr. Anurag is, with strong cash flows and ongoing expansion, how do you plan to sustain EBITDA margins while funding new investments? From a financial point of view, how will you manage working capital cycles, hedge Forex exposure on export revenues, and apply digital cost control initiatives to ensure return on equity remains strong and the balance sheet keeps on strengthening over the period of time? Thank you.

Anurag Bhagania
CFO, OneSource Specialty Pharma Limited

Hey, Sucrit. Thank you very much for that question. It's part of our inherent fabric that we have built over time. Looking at each of those dimensions that you talk about, built around controls, built around process strengthening, and use of digital interventions across the board in our financial processes. We are building a future business with very strong foundation, all of that is part of our process.

Operator

Thank you. We have the next question from the line of Mehul Panjwani from 40 Cents. Please go ahead.

Mehul Panjwani
Analyst, 40 Cents

Good morning, everybody. Thank you so much for the opportunity. My first question is about the comment about the two soft quarters. Can we expect complete normalcy to return to the revenue recognition after two quarters? That is my first question.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. We have, as both Arun mentioned in the beginning and I reiterated, that once we have a visibility on the approvals coming into the major markets and we start supplying. We are absolutely going to be having a sequential improvement in quarter after quarter. That's exactly the plan, as you highlighted.

Mehul Panjwani
Analyst, 40 Cents

When would we know about the visibility on the approvals?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

We continue. That's what we have said. If you have seen our customer, especially what is in public domain, Dr. Reddy's very clearly said that they are expecting approval coming in anytime between February and May. That's what the confidence level of our customer is on what we are also working towards.

Operator

Thank you. The last question is from the line of Abdulkader Puranwala from ICICI Securities. Please go ahead.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Yeah. Hi. Thanks for the follow-up. Sir, just quickly on this new oncology contract, what you have had with one of the largest companies. Could you help us understand what is the opportunity here and when the supplies actually start?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. This is a product, as I mentioned, which has been approved through the NDA route. It is a branded product. It is a fairly unique opportunity. There is just one more company offering that product in the market. This is a product which we should be launching in the next quarter. It should be launched by our customer in the next one quarter.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Got it. Just on semaglutide approval. I know that the timeline would be set by the regulator, but just to understand in terms of our supplies. If say, one of your customer gets an approval in, say, Q4 or Q1, by when should that exactly reflect into our numbers? That is, by when the supply should begin for us?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah. Abdulkader, we will, as soon as approvals come, because there are some aspects which will have to be put on the individual pen post-approval. It would be fairly soon after the approvals come that the supplies will start. Of course, the volume ramp-up will take its time, but the supplies will start in very short order after the approvals come. Whether it is in Canada or any other market, very soon after the approvals, the customer should start putting the product in the market.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Okay. Final one from my end. We had previously announced the acquisition of the two injectable facilities. Where are we in that transaction right now?

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yeah.

Anurag Bhagania
CFO, OneSource Specialty Pharma Limited

Hi. This is Anurag. The process is working very well. It has moved forward. When we spoke last, it was an application submitted to the stock exchange. There is a discussion between the stock exchange and SEBI. Process is working very well. We anticipate us to be able to get the final all regulatory approvals in place by third quarter of FY 2027.

Abdulkader Puranwala
Research Analyst, ICICI Securities

Got it. Thank you.

Operator

Thank you very much. Ladies and gentlemen, in the interest of time, that was the last question for today. I now hand the conference over to the management for the closing comments.

Neeraj Sharma
CEO and MD, OneSource Specialty Pharma Limited

Yes. Thank you very much, everyone, for coming in on a Saturday morning and listening to us. We wish you a very pleasant long weekend. Thank you.

Operator

Thank you very much. On behalf of OneSource Specialty Pharma Limited, that concludes this conference. Thank you for joining with us today. You may now disconnect your lines.