Onesource Specialty Pharma Ltd (NSE: ONESOURCE) Q4 2025 Earnings Call dated May. 06, 2025
Corporate Participants:
Unidentified Speaker
Arun Kumar — Founder and Non-Executive Director
Neeraj Sharma — Chief Executive Officer and Managing Director
Anurag Bhagania — Chief Financial Officer
Analysts:
Unidentified Participant
Aman — Analyst
Madhav Marda — Analyst
Abdul Qadir — Analyst
Rupesh Tatia — Analyst
Alankar Garude — Analyst
Ritwik Sheth — Analyst
Aman Vij — Analyst
Presentation:
operator
It. Ladies and gentlemen, good day and welcome to the One Source Specialty Pharma Limited Q4FY25 earnings conference call. As a reminder, all participant line will be in listen only mode and there will be an opportunity for you to ask question 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 Mr. Abhishek Sengal. Thank you and over to you sir.
Unidentified Speaker
Thank you Sejan Good morning everyone and thank you for joining us today for the earnings conference call for the fourth quarter and full year ended financial year 2025. We’re pleased to have with us Arun Founder and non Executive Chairperson Neeraj CEO and MD and Anurag CFO who will walk us through the key business and financial highlights of the quarter. I trust you had the opportunity to review our results release and the quarterly MISA presentation, both of which are available on our website as well as the stock exchange website. The transcripts of this call will be posted in the company’s website within the next week. Please note that today’s discussion may contain. Forward looking statement which should be viewed. In context of the risk inherent to our business. Should you have any further questions after this call, our administration team will be happy to assist you. I now hand over the call to. Arun for his opening remark.
Arun Kumar — Founder and Non-Executive Director
Morning everybody and thank you for joining us bright and early today. Appreciate your time. It’s a pleasure to have this conversation especially given one source has come back from a very difficult scenario. Little over two years to deliver on everything that we said we would pre listing and post listing. It’s been a pleasing outcome for the quarter. As you’ll notice from the numbers we recorded a phenomenal top line growth and a very Significant EBITDA and Q4 has been an outstanding quarter. But I would also like to put some color around the quarter performance. Not as granular as it is in the decks which I’m sure most of you have read it, but I just wanted everybody to understand that we’ve had the privilege of adding several customers especially in our GLP and EDC space and consequently we had a Great run in Q4 led by increased execution of several contracts.
These were new customers that we onboarded in the earlier part of the year and typically are typically challenges to the earlier filers. Consequently there has been a rush for capacities which we were able to deliver and that has resulted in a good outcome for one source. We continue to maintain our near term outlook for FY28 for a $400 million revenue top line with a significant EBITDA in the 38 to 40% range as has been previously guided organically and we are very committed to achieve these objectives based on a strong order book that we have had now secured.
FY26 is going to be a transition year and I just want investors to be fully conscious that there are several events that lead to us to give this kind of a tepid conversation around how FY26 would look like. Predominantly, as you know that bulk of our revenue growth will come from the commercial sales of our DDC products. We are currently on track to believe that almost all our partners will be in a position to supply products in key markets on market formation. And as you know that most of the markets open up towards the end.
I mean towards the actually the beginning Q4 of this financial year and Q1 of the next calendar year. So consequently, depending upon the freedom to operate and the various regulatory approvals that our partners need to receive a lot of our commercial supplies of the DDCs will determine how FY26 will look like. Consequently, it will be lumpy. There would be quarters which would be extraordinarily high performances like our Q4 quarters. It will more or less mirror FY25 with H1 being a lot tepid compared to a very strong H2. And that’s what we think we will achieve.
Our endeavor is to ensure that our exit run rate, while we will not be able to meet that Q on Q on an annualized basis, we would be in that zip code. That’s our endeavor. But like I said, a lot of that is dependent upon product approvals and customer approvals. Our order book continues to be very strong in all the subsects of our business. And while our Biologics of Substance business is nascent, we are seeing strong traction and I led both Neeraj and Anurag and Neeraj to talk on the business side and Anurag on the finances and the balance sheet that they would give you more granularity.
But I just thought it was important to set the context for FY26. 27 would be a very solid consistent Q on Q growth. 28. We will meet our near term guidance organically that we have. We have delivered kind of provided an outlook when we listed and did the road shows for the pre IPO placements. And then of course we believe that from all our enablers and our significant CAPEX expansion, we are ready to get to that near term numbers. So thank you for listening to this overview and then I will and I’ll request Neeraj to get into the granularity of the business. Thank you all.
Neeraj Sharma — Chief Executive Officer and Managing Director
Thank you Arun and welcome everyone to our Q4 and full year results as a listed company. In fact journey of one source from merely an idea two years ago and through all our NCLT approval process culminating in listing and now our first full year results have all been hugely exciting for all of us at one source. What really gives me a feeling of great satisfaction is that our inception philosophy as a one stop CDMO continues to play out now. We have added 15 new customers across all our service offerings. We have won multiple RFPs in this time and it’s equally important that while we have added new customers and got new business from them, there has been significant repeat business coming from our existing customers which really shows very strong trust in our capabilities which our customers have.
We have increased our total logo count to to more than 70 now with our customer base including leading innovator companies. We’ve got biotech, we’ve got top of the global generic companies so you name it and we have as our customers. And the very fact that our customers trust in our capabilities is not only is across our service offering but especially if you look at drug device combinations where we have delivered almost 50 projects whether fully delivered or in terms of various stages of execution including GLPs, all GLPs but beyond GLPs as well as well as both small and large molecules.
And what has really helped all these new RFPs which we have won, the licensing deals which we have gotten into the very high level MSC executions which we did especially in BDC which Arun mentioned in his opening talk. All these have together helped us deliver a very strong performance in Q4 but also in the full year FY25 with full year revenue in excess of 1400 crores which is up 30% versus previous year and an EBITDA of 466 crores which is more than twice of FY24 I think which is really a commendable feat I think which the team has achieved.
Our Q4 EBITDA margin which is at 43% reflects really the impact of drug device combination even if it’s most of it has come from MSAs. We’ll talk more Anurag when he talks about the numbers later. What also gives me immense satisfaction is our compliance track record which continues to be stellar. We had more than 60 regulatory and customer audits during the year across our sites. In fact we had successful FDA reinspections at our penicillin and German injectable sites. We had Health Canada coming in. In fact our flagship site received approvals from Anvisa from Saudi agencies among others which is really going to pave the way for us to start supplying semagluti when it in these markets as our customers get approvals and patents expire in early 2026 calendar then really in anticipation of the launch of Samaqduti we have always mentioned even in our last call and in all our interactions that are progress towards expanding our capacity especially in drug device combination is on track.
With the first phase set to conclude towards end of the year again Anurag will talk a little bit more on our CAPEX program. So while you know our new customers and RFP wins continue across all our segments, we are also going to be having big commercial launches in the next 2024 which we have set and along with our stellar compliance record we are very happy to reaffirm the outlook which we gave last time which is of FY25 to 28 revenue growth further of 30% and a steady state EBITDA of margin of 40%. And of course Arun already mentioned and I would just reiterate that how the current FY26 is a really pivotal year for us when this is a year when multiple drug device combination projects move from the MSA to the commercial stage and the SEMA patent expiry happens in some of the largest markets we have seen Canada, Brazil, Saudi Arabia, India et cetera in Q4.
And obviously while the launches will depend upon our customers getting approval but the very fact that many of our customers have paid us reservation fee with take of pay arrangements is a mark of confidence. Obviously FY27 which is the first full year of commercialization for SEMA in many markets will see the CSA contribution to our business more in line with steady state. Finally what we also have done in this last quarter and FY25 is to really strengthen our leadership team with number of new additions you have we have shared with the market but also not only at the leadership level but also at levels at the critical operational levels.
We’ll continue to do that. Also as we had mentioned in our last call, we have now in this quarter really brought in a very highly accomplished board led by our founder Arun which obviously is working with the leadership team and myself to help us reach our aspirations really to make one source a really respected global pharma cdmo. Thank you for thank you for your time and I’ll ask Arunav to Take you through our financial ratios and other financial highlights.
Anurag Bhagania — Chief Financial Officer
Thank you. Thank you Neeraj and good morning everyone. Like Arun and Neeraj already mentioned on the call, we had a very strong financial performance for this quarter and for the full year. I am pleased to take you through our quarterly and full year financial numbers. Revenues first in Q4 revenues stood at Rupees 4260 million and they grew 22% on a full year basis. Revenues were Rupees 14449 million and they grew 30% year on year on EBITDA impact. With the strong growth on the top line coupled with our stable cost base, we continue to see a strong operating leverage play out.
And I’m pleased to report that for the quarter and operating EBITDA of 1,825 million up 79% year on year and what’s pleasing to see is that the pack of 992 million for the quarter is actually versus a loss a negative pat in the prior year. On a full year basis we delivered EBITDA of Rupees 4665 million and an adjusted pack of Rupees 936 million excluding one timers adjusted PAD. As you know, PAD excludes one timers and exceptional items relating to formation of one source, primarily regulatory fees, taxes, duties and prepayment of interest. Our EPS for the quarter stood on an annualized basis at 48.9 and for the full year at 21.4 on a fully diluted basis.
EPS calculations however exclude exceptional items and scheme related intangibles that are being amortized. ROCE’s, you know quick highlight our ROCE’s for the full year are 22.9% and Q4 annualized 40.9% close to 41%. But beyond the numbers, this quarter continues to be a transformative period as we build one source the critical pieces on the integration program. As you know we already spoke about it in the last call we got listed earlier this year but now we are working very closely with our commercials and operations team, the supply chain teams to integrate the business and we have made significant progress towards that journey.
It is a comprehensive integration program, systems, processes, but most importantly the various IT systems. It will tremendously help one source in terms of driving customer wallet share and operational synergies. On the treasury operations during the quarter we see very strong operational cash driven by strong collections from our customers across the businesses. This year we prepaid high cost debt and complicated debt earlier in the quarter and we reduced it by almost 50% by the end of last quarter itself net of cash and cash equivalents. During this quarter we further reduced our debt to 4,707 million net of cash and cash equivalents.
And we anticipate maintaining a healthy below 1 and a half debt to EBITDA over the medium term. We, like we earlier mentioned, we aim to be debt free, net debt free in the next two to three years. With the significant reduction in debt during the year coupled with our credit rating upgrade, we have now better access and economical access to funds. And therefore our interest costs are down to 278 million this quarter. Down 20% quarter over quarter and significant reduction versus prior year on our growth programs. As you already know, we are executing our plan to expand our capacity and capability and will continue to invest over about $100 million over the next couple of years.
And we will consciously balance our ability to leverage and access funds at attractive terms as well as our internal accruals and customer participation in those programs. Fixed asset terms. We anticipate that we will remain higher than two fixed asset terms currently already at 1.9. As a reminder, as part of the scheme of arrangement, we are carrying Rupees 10,572 Million of intangibles and about 38,275 Million of goodwill as of March 2025. This is as per appropriate accounting guidance owing to lack of common control between the three entities. Therefore, we will have to. We will have a slightly inflated balance sheet for the time being and you will see more coming along the way as we work through this.
Thank you once again for our first annual results call and I will hand it back to Abhishek for opening the line for questions.
Unidentified Speaker
Can you take your questions now please?
Questions and Answers:
operator
Sure, sir. 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 are requested to use handset while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembled. The first question is from the line of Nathana Grewal from DAM Capital. Please go ahead.
Unidentified Participant
Hi. Thanks for taking the question and congrats to Arun Neeraj and the management team for a fantastic F25. Arun, just taking off from the comment that you made on the F26 guidance. Just to be clear, I think what we should, you know, F25.6, which is kind of closer in nature to F25 where bulk of the revenues in DDT will still be coming from milestones and licensing fees, etc. From the contracts. And the commercial revenues will be little back ended maybe as in because the patents for FEMA really begin to expire only toward the end of March 26th. So 27 is where the commercial revenues will begin to really pick up leading to 28 guidance as you’ve guided put it out already.
Arun Kumar
Yeah, that’s right. So FY27, you’re spot on. FY26 the first market that opens up is in Canada which is in the early days of January of 26 and bulk of the countries go up back in March of 2026. So commercial supplies, if everything goes to plan would only start in Q4 from a freedom to operate perspective. But then we are working through that. In the interim we continue to have MSAs including DDCs as we acquire more customers. But given that we have a very strong number of customers in DDC we have now 20 plus customers manufacturing with US drug device combinations.
It is prudent for us not to onboard additional customers because then there will be a clash for capacity elsewhere in the deck. You’ll notice that we have increasing capacities from our 40 million rated capacity to a little over 90 million as early as December. So we also want to be conscious about allotting capacity to the customers that have either provided a takeo pay contract to us and or we have very specific long term arrangements. So consequently taking more customers at the cost of, you know, upsetting established customer relations. It’s not something any CDMO for that matter we would do.
So we would have a lull here in onboarding new TDCs for GLPs. Of course we look at adding customers around other formats but yeah, like you rightly said, 27 could be more defining and more predictable. 26 our goal is to set all the right enablers that get us to their 528 guidance of 400. Our aim is to do much better. Obviously we do a lot better than FY25 absolute numbers that were announced today yesterday rather. But can we grow significantly greater than our exit rate would be all up in the air because of the situation that I just explained.
Unidentified Participant
Thanks. And on our F28 guidance, to your mind, what are the risks if any, which one can sort of keep in mind while looking at that number. What are the risks one you should can crystallize which can impact the guidance?
Arun Kumar
Well, I think in the near term we do know that There are several GLPs in the works but there’s also very significant new users and new clinical Trials delivering outstanding results. So we think that this space will expand with multiple treatment options. We believe that the need for self medicated injectable auto injectors would continue to be a significant part of the business. We also believe that a lot of the global markets are are unmet which will expand quite significantly both from affordability and ability to cover a larger population. You’re probably aware that even the WHO has now added OBCD as a as a key area of focus for them and are considering GLPs as a solution.
So all of that should significantly expand the market opportunity in my view. So we don’t see any near term risk in the market. We believe that when orders do come in there will be an impact. But I think a combination of burden and pricing and availability of these products in the markets that have gone off patent or will go off pattern in the next 12 months would be more a function of timing. So I strongly believe that we do not see any risk to our FY28. And of course we have several levers, right Nitin? There are several levers.
Ever since we opened up our books of CDMO across our platform, we have a flurry of RFPs across our soft gelatin business, our injectables business. You will see in our deck that we would become very significant players in high viscous pre filled syringes. So we’re adding new capabilities and subsets within our product platform. We are cross selling a lot, as Neeraj already mentioned, we are able to secure a lot of customers across various subsets of our platforms and domains. So we’re very excited about the summer and I think we’ll get there without difficulties. Compliance is an added risk.
We believe that we have a strong group. You know, we are recognized for being a leader in this space. We continue to heavily invest in digitalization and upgrading our quality standards. We all know that we are only as good as our next inspection. But yeah, we’re very confident as we go out with the kind of enablers and the team that Neeraj has been able to assemble in a short period of time to deliver on the FY28 outcomes.
Unidentified Participant
Thank you so much. Best luck.
Arun Kumar
Thank you.
operator
Thank you. Before we take the next question, a reminder to all the participants that you may press and one to ask questions. The next question is from the line of AMAY from GM Financial. Please go ahead.
Aman
Yeah, thank you for taking my question and congratulations to the management. And first question I have, is it possible for us to give a breakup of DDC revenues for either quarter or for full year.
Neeraj Sharma
So hi, so we are not specifically giving DDC number, but I think we have very clearly mentioned that, you know, today as we speak we are close to about 50 DDC projects. Right. These are in various stages of execution, some have already been delivered. Some of these projects just waiting approvals which will go into the commercial launches as Arun already mentioned, towards the end of this financial year. And then there are other projects which are currently in still in the pre approval MSA stage where we will continue to derive income as revenue stream which is MSA revenue which we have seen already giving us a very strong year and quarter last in the last quarter.
So while DDC will obviously be a significant driver or continue to be a significant driver of our revenue in FY26 and beyond, also in our obviously FY28 outlook which we have given. But also it’s not just gdc. I think that’s also the point. Arun just mentioned that our business has got multiple legs. Of course DDC is a significant growth contributor, but also whether it is stride deductibles, whether it is soft gelatine capsules where we have recently added capacity and taken the capacity to 3x and we have got multiple new customers on board it. So yeah, so while ddcs will continue to lead our growth strategy, but we have got all service offerings contributing.
Aman
And the second question I have is on the new commercial, new line which will get added by quarter four or December of this year. So will we need a reinstation or validation and that will take some time and then the actual commercialization happens from that line or is it from December onwards we’ll start generating production from that time?
Neeraj Sharma
Yeah, so the line which is getting added is getting added in our current site within the current suite itself. And as far as our understanding of guidance, FDA guidance goes and various regulatory agencies, because remember these markets, the first market which will open up are Canada, Brazil and so on. So based on our understanding of guidance, we do not need another inspection. So we should be able to get into the market as soon as we are ready and qualified lines.
Aman
Just last question, if I can squeeze in the first market is Canada like you said. And so here, if at all our partner is not able to get the approval, still are we expect to get revenues or like how things will pan out then.
Neeraj Sharma
I think it’s very important, as we have always said, right, that we have got our customer base which is who’s who of the, of the global industry. So it’s not, you know, we are not dependent upon only one customer, you know, We’ve got multiple customers and you know, all our customers feel they would be in a good position to enter the market at the time of market formation. And honestly, you know, you know, for us what is important is at least some of our customers get approval. It’s not important that every single customer needs to get approval.
But even if some of the customers get the approval, we are all set to support whichever customer gets the approval. We are all set to, from a capacity point of view to be able to be able to service these customers. So our outlook is not dependent upon one customer or two. We have a very, very large and diverse customer base.
Aman
So thank you so much. I will join the session.
operator
Thank you. A reminder to all the participants that you may press Star and one to ask a question. The next question is from the line of Madhav from Fidelity Investments. Please go ahead.
Madhav Marda
Hi, good morning. I just wanted to understand that as the Canadian and the Brazilian markets open up initially next year for Semagluca generics, is there any sort of broad sense in terms of how much the volumes of the patient base in these markets can expand like as the prices come down as Generic Center? Would you have any sort of reading on that? Thank you.
Neeraj Sharma
I can, you know, without going into very specific numbers, I can just tell you the following, that both these markets, like most markets which are or almost all markets which are coming of patent in the next year have been very, very poorly served. In fact, the key driver in these markets will be increased access. Just to give you some idea that in a market like Brazil, which is one of the largest population markets globally, the penetration the way it has been Novo has served the market. There is less than 1% penetration of what it should have been.
In Canada it is about 4 or 5% penetration. So you know, we see these markets right now. What the numbers which IQVR shows are really not reflective of the true demand. And once there are genius cleared in the market and there is a much higher access, we see the markets really taking their true potential, which could be anywhere between 10 to 12 times in case of Brazil, for example, or maybe about four to five times in case of Canada. So we see access really driving the growth in these markets.
Madhav Marda
When you say four to five times in Canada, that means you’re saying the number of pen sold or the patient pool can potentially be four to five times higher. Right? That’s the way to read it.
Neeraj Sharma
That’s correct. What depends upon what the ICV numbers are today.
Madhav Marda
Thank you.
operator
Thank you. The next question is from the line of Abdul Kadir from ICICI Securities. Please go ahead.
Abdul Qadir
Yeah, hi. Thank you for the opportunity. So my first question is with regards to your order book and capacity addition. So in your opening remark you talked about a strong order book and you know you’re talking about increasing your capacity also because to 90 million. I mean you know, how should we look at the utilization part considering me, you know you’re talking about a significant capacity to be added in, you know, across your business segments over the next one, one and a half year period.
Neeraj Sharma
Yeah. So Abdul, thank you for your question. So what we are we’ve mentioned in our talk today and also in our deck you will see that we are already at close to about 50 duck device combination projects, right. Some of these already executed, filed, waiting approval, some are still under execution. So our capacities which we are currently having and also what we are adding towards in this year, towards end of the year will be servicing both our ongoing MSAs as well as CSAs. And obviously the rated capacities are really seen when the full commercialization happens and we take the batches as per commercialization.
So the key for you to understand is that our order book is very strong because we have got these 50 odd projects ongoing or delivered across our customers. We have got forecasts from our customers going up to next three years. So that’s the way we are spending ramping up capacity in line with our customers forecast in line with the patent expiry which are happening over the next to three years. And when we see our order book today based upon what our customers are saying, I think we have a fairly strong utilization of especially the first phase which we are putting in.
In fact that’s why we have mentioned that we are not, you know this is just the first phase which is getting over this year. We are just behind this by end of next year, FY 2026 we will be adding, you know another we will be almost doubling the capacity from where we will be at the end of 2025. So this is based upon proactive move from our end to make sure that our customers demands are met and that’s what our customers trust us to do.
Abdul Qadir
Got it sir. My next question is pertaining to your NCE and NDE project. So I see in your nursery deck that there is one new project getting added this this quarter. So any color on you know by when would you know the revenue booking in a meaningful way happen from this particular segment and in your DDC business and just specific with your biologic, NDE and CE part of the business?
Neeraj Sharma
I’ll Just talk about the MBE part first because the MBE as you know that biologics as their very nature have got long gestation and obviously it’s a first in class product which we have. We are right now in the phase of doing clinical production which is what will happen in this year. And based upon the approval timelines as you know we expect the product to be commercialized somewhere between 28 and 29. In fact we have said earlier that our our near term outlook which we have given does not include contribution or any meaningful contribution from the commercial sales of the NBE which we have.
So it will still be a lot of pre approval revenue which will be coming in that output for other NPE minus 1s. Again as you can appreciate I will not be able to give you specific details but I can tell you that there are products in various patent expiry there. Some launches could happen as early as FY27 and some could be calculated. But these are very significant opportunities because in some we have the complete exclusivity as M3 milestone files.
Abdul Qadir
Got it sir, thank you and I will get back in.
operator
Thank you. Ladies and gentlemen, you may press star and one to ask a question. The next question is from the line of Rupesh Tatia from Intelsense Capital. Please go ahead.
Rupesh Tatia
Hello sir. Thank you for the opportunity and congratulations on great set of numbers. My first question sir is they’re not talked much about non GLP DDC projects. I think PPT mentioned several of them, seven at least were one recently and which are high value molecules. So it would be great if you can, you know, provide some color on this, you know, therapeutic area. What would be the commercialization timelines? What would be the potential of these, you know, non GLP DDC molecules And they sum up to let’s say 10, 20 million in volume. If you can give some color on that, that’ll be really helpful.
Neeraj Sharma
Okay, thanks for your question. Now here we have. The question is very valid and we always said that our expertise is around drug device combination and not any specific molecule. Obviously we are in a very sweet spot as one of the biggest growth opportunities which is GLP1. But our capability and our portfolio is much beyond in drug device combination. As you can appreciate keeping customer confidentiality. I’ll not be able to give you specific molecules. But what I can tell you is that in fact our first drug device combination product which got approved in US for our customer is actually is a non GMC it cervix the peptide and it’s a very unique product.
It’s first of its type. Even the innovator doesn’t have that drug device combination. And we expect the commercialization to happen in FY26. Our first product which got approved in Europe as a drug device combination is a biologics peptide. And we expect that commercialization to also happen in FY26. And there are a number of other products which are in the pipeline. But what I can, you know, in fact we’ve got 10 plus total products for in drug device combination, total molecules. And I can also tell you that you know these are, these are, these are good products but obviously the volume are not in line with, you know, with the likes of GMBs because the markets are very different.
But these are attractive products for us because per unit realizations are very, very attractive. But also the fact that many products which are in the pipeline are drug divide combination. I’ve always said that the move towards self administration is a big driver of global R and D dollars. And that also is a big boost to our business. Especially because as I said our expertise is in doing drug device combination. And you will see more, you will see us adding significant numbers when we talk about our funnel for drug device combinations.
Rupesh Tatia
Okay, Good to hear Dr. My next question sir is and congratulations on passing on VISA audit. So one clarification, there now is for Brazil approval. There is no pending action on at least one source. Is that a fair assumption to make? And then similar update can you give on Health Canada. I mean is Health Canada inspection done or there would likely be another inspection before the product gets approved.
Neeraj Sharma
Yeah. So your first point is correct that as far as Brazil is concerned, one source is, is all set. Whether from approval of our site or from our capability and capacities. We are just now awaiting customer approvals before entering starting manufacturing for our customers. As far as Health Canada is concerned, if you are aware, Health Canada will not come and inspect as long as a site has FDA or European approval. And as you know we have both European and FDA approval. So we don’t expect Health Canada requiring any inspection before giving approvals from our site.
Rupesh Tatia
That’s, that’s very good to hear sir at this point final question sir is on Miraglutide launch and where, where are we on that? And then I think on March 29th you, you gave one notice to exchanges that one of our site received four observations. It was not. I was not sure if it was for ddc. So maybe, I mean where are your lutide launch and whether those observations has, you know, delayed the lirabutite launch? In US markets.
Neeraj Sharma
So no, first I’ll answer your last question further. There’s delay on lirabout launch. You know, whether because of any observation or not. We already are talking customers have got lira duty approvals already, especially for Europe and in the process of launching. I think this launch could happen as soon as next quarter because we are set for launch. It’s not. It depends upon our customers also ability to be able to launch and for us to actually enter the market with them. But for your question around the observations, yes, our site was inspected as a norm. We did get some 483observations which are also norm.
We have already responded to FDA on those and we are confident that we will close out that inspection also. But.
operator
Thank you. The next question is from the line of Alankar Garude from Kotak Institutional Equities. Please go ahead.
Alankar Garude
Hi. Thank you for the opportunity. Sir, can you talk about the pricing. Arrangements of your takeover pay GLP1 contracts? So what I mean is from a pricing standpoint, are your contractual terms broadly similar across all clients for GLP1?
Neeraj Sharma
Yeah. So I can tell you the following that we have, as you said, many of our customers need access to capacity and in order to get access to capacity, you know, we have number of arrangements with our customers. Some customers have participated in our capex program. Some have done take or pay deals with us, some have done given us reservations long term forecast. So there are multiple ways where customers are securing access to capacity which as you know is the single most rare commodity right now, which is capacity. So I think that’s what I can tell you right now for as far as our pricing and contractual.
Alankar Garude
So sir, these contracts basically have an. Annual price revision built in.
Neeraj Sharma
So I think, yeah, I think it’s as you can imagine as a cdmo, you know, I. There’s only so much I can tell you on that. But I can tell you these are if these are commercial contracts, these are long term contracts, you know, and that’s what our customers looking from us that we, we support their them right from market formation to their securing market share. I think that’s what. And that’s what they are, that’s what they will be paying us for.
Alankar Garude
Okay sir, so maybe a final question related to this. When you talk about $400 million sales by FY28, are you assuming pricing per pen to be stable in a given market like say Canada till FY28?
Neeraj Sharma
I can tell you the following, right, that if you are, if your concern is around in market pricing, I can’t comment on that simply because that’s the function of how our customers will be pricing and how that dynamic plays out. I just want to say that we are as a cdmo, we take only a small fraction of the in market price. So the impact of anything going around in the market we don’t see impacting our pricing in any way. Our pricing is anyway based on volume. We do staggered pricing based upon volume and that’s how our customers want and that’s how we are protected.
And having said that, we also feel that there will be. There may not be as many players in the market, especially at the time of market formation as you may be thinking.
Alankar Garude
Understood. But sir, just that clarification on your assumptions which are going into that guidance.
Neeraj Sharma
I mean people, sorry, I think there is a. We have limited time and a long queue. Maybe you can come back in the queue and let others have a chance, please.
Alankar Garude
Fair enough, sir. Thank you. And all the best.
operator
Thank you. The next question is from the line of Ritvik Sheth from oneup Finance. Please go ahead.
Ritwik Sheth
Hi, good morning, sir. So just one question. So any of our customers are heading. For a launch in India or China? These are all predominantly Brazil and Canada.
Neeraj Sharma
We have, as I mentioned, we have a global customer base, a very diverse customer base and most of our customers are global players. So as a global player they have multiple markets which they are targeting. And for sure India could be one of the markets where customers are wanting to enter. But as a CDMO partner of choice, we, for us we are completely agnostic. Where our customer really wants to sell the product, it will definitely be Canada, Brazil and some of the other markets. And yes, India could very well be one of the markets. Okay.
Ritwik Sheth
And just a follow up on this.
operator
Sorry to interrupt, sir. I would request you to please use your hand, sir.
Ritwik Sheth
Yeah. Is it better?
operator
Yes, sir.
Ritwik Sheth
Yeah. So just to follow up on this. Would there be any difference in realization. For our services offered to a customer. In Canada and India for the same product? Because the price would be significantly different. So would our service charge or our. Charges be significantly different?
Neeraj Sharma
My simple answer to that question is no. For us, geography is not really important. Our customers where they are really launching the product is not important. For us, Our pricing is purely volume based pricing and it is completely agnostic of the geography. Okay, great. Thank you. And all the best, sir. Thank you.
operator
Thank you. The next question is from the line of Aman Verj from Astute Investments. Please go ahead.
Aman Vij
Good morning, sir. My first question is on our Lira. Terry and Sema launches in H1 and H2. If you can just give the number of launches we are expecting of these three individual products in H1 as well as H2.
Neeraj Sharma
Yeah, again these are. We have said that we have 10 molecules in DDCs and these include some of the ones which you mentioned. I obviously will not be able to give you very specific around these products but it would be sufficient to say that depending upon the patent expiry and the approval our customers would receive, we would most certainly be bringing or launching these products into the market in FY26.
Aman Vij
If you can talk about the commercial launching for commercial we were expecting 8 to 10 in. All.
Neeraj Sharma
These products would be, you know, launched commercially. As you know for DWT already said we have approvals. Our customers have approvals in Europe and we do have approval also for steady parasite. That also proverb we have. So the plan is to be launching these products within FY26.
Aman Vij
But you are not commenting anything on the number of launches. Like earlier you were saying eight. We were expecting eight to 10. Does that number say or some have. Been delayed to FY27? That was the question.
Neeraj Sharma
I don’t think we have ever said any particular number of launches. But as we have said that our LIRA approvals already in place, we have got the already in place they would be coming into the market and there are. You know what we have said that there are many products which would be moving from MSA to CSA as approvals come in. So there is absolutely no change to what we mentioned.
Aman Vij
Sure sir. On the next question is on the competition trend for life. So oral competition you have talked about. But for example, ll have launched the products in India in form of rail. So do you expect a similar thing to happen in other geographies? Because then that is a risk to our GDC model. If you can talk about that.
Neeraj Sharma
The entire western world is very clearly, as I said the whole idea of these products is self administration. And I think that’s where the market is, that’s where the entire move is and that we see no change into that because wireless require intervention of healthcare professionals and that is exactly against the whole concept of health administration. So we don’t while markets like India it could well be possible the vials. But the very fact that it is a self administration group is what is important. Having said that, I also have to tell you that our capacities are fungible.
In fact all the new lines which we are putting up at our flagship site are combi lines which are actually which can to both vials as well as cartridges. So it is depending upon how, you know, how our requirement is, how our customers requirement is. You know, we could, in these lines, we could do 100% cartridges or 100% vials.
operator
Thank you. The last question is from the line of Amangada from Everno Capital. Please go ahead.
Unidentified Participant
Hi sir, thank you for taking my question and congratulations on great set of numbers. So my question was again slightly on the demand side which the last participant asked there. You know, a lot of new therapies are coming for weight loss and lot of oral drugs are also gaining traction in GLP for weight loss and diabetes as well. So do you see or anticipate or your customers in turn anticipate some softness in demand not in near term, but in a farther term, two, three years down the line?
Neeraj Sharma
I think we have always maintained that orals will have a place in the anti obesity market. And that’s how it is how we see Lilly has come out with this product. But there are a couple of things to look at here. This, the fill burden which is there for a oral product which requires a daily tablet and the fact that compared to that a once a week injectable I think is a very different ballgame. In fact, if you see, even Lilly has very clearly mentioned that they expect the peak of their oral product to be no more than 25% of the total antiovesity market.
So keeping that in mind, you know, we are, you know, we are very confident that the mere access of the drugs, of the, of the injectable drugs is going to be significantly higher. Right now the penetration levels are so low in some of the largest markets in the world and that will continue to drive. As I said, orals will have their place, but their role will be limited to that 20, 25% which even the innovators are talking about. And remember, while there are oral therapies in the play, there are also injectable therapies in the play which are once a month injectable, for example.
So if that were to come once a month injectable obviously is again way more attractive than a daily tablet in any form.
Unidentified Participant
Understood. So we don’t see any demand challenges as such in terms of our visibility. So now a very small update. I would require that you know that the capacity that you are adding, the 220 million which are planning to go, all of this is planned to be added in India or some capacities to be planned outside of India as well in terms of location.
Neeraj Sharma
Yeah, right now the number which we have given are primarily for expansion in India. But as a PDMO with global footprint, global aspirations, we will certainly continue to explore opportunities to expand outside of India. These expansion could be through either organic route or even inorganic route. So that we continue to evaluate.
operator
Thank you ladies and gentlemen. That was the last question for today. I now hand the conference over to the management for closing comments.
Neeraj Sharma
Yeah. Thank you. Thank you everyone for, for joining us early in the morning and asking some very, very insightful questions. This was our first full year call and we really look forward to your continued interest and we look forward to speaking to you again in the next quarter. Thank you very much.
Anurag Bhagania
Thank you.
operator
Thank you. On behalf of oneso Specialty Pharma Ltd. That concludes this conference. Thank you for joining us. And you may now disconnect your lines.