Thank you very much. We will now begin the question-and-answer session. The first question is from the line of Anand Mundra from Soar Wealth. Please go ahead.
Quarter ended Jun 2025
Good morning, sir. Sir, my questions are related to Canada market. So what is your view? How many players would be launching in this market during the first phase and how many generic player market would be there in Semaglutide in Canada? That was my first question sir. I have two more questions.
Yes, I'll just answer this. So, your guess is as good as ours. We are seeing right now there are a few companies who have filed in Canada. Now which ones will get approval, we really don't know. But our guess is these are complex products. So we don't expect the market to be crowded as when the market gets formed. So, in our view, there will be at least at the time of launch, there will be a limited number of players into the market.
Okay. Sir, second question with respect to approval. So what is your assessment or sense on January 2026 as a launch for Sema generics? Is there any risk of delay for approval?
Yes, again, what I would only say here is that these are complex products. But also the companies which who have filed are some of the biggest and the top generic players who are used to handling complex products, who are used to getting approvals. We have already seen some companies getting approvals of Liraglutide, both in Europe and in the US. I think that that gives confidence that companies will get approval. Now when that approval comes and who comes first, I think it's really very difficult for anyone to answer that.
Thank you, sir. Thank you.
Thank you. The next question is from the line of Nitin Agarwal from DAM Capital. Please go ahead.
Thanks for taking my question. Two questions. Neeraj, on the capacity that you talked about, now if you can just clarify, when does the 200 million capex plan from here on? Or when does the 200 million vial capacity come through, or cartridge capacity come through now?
So, Nitin, what we had said, right, that we will be the capex we are building, we will be having all capacity up and running by FY '28. Now we have actually brought it up significantly because we have advanced our third line actually also earlier. So we would be having now this capacity, all capacity up and qualified by end of calendar 2026.
Okay. And secondly, you also mentioned in your comments about increasing customers, increasing their -- increasing the order sizes, new customers coming on with a lot of take and pay agreements along with it. So if you can just probably help us understand, A, what proportion of the capacity that right now, I mean, is covered right now with the sort of firm contracts? And generally speaking, is it fair to assume that all of this capacity is backed by take-or-pay?
So I can, I mean, what I would say here is that the months which we are launching, especially the markets which are opening up early starting January next year, all the customers who are scheduled or planning to launch in all these markets, all have take-or-pay contracts. We have take-or-pay contracts with all of them. And they will take up significant part of the capacity, especially over the next anywhere between 18 to 24 months, because as the launches ramp up and the volumes ramp up in the market, they will -- that's what we are looking at if it answers your question. Arun, please.
Yes. Nitin, just to add to what Neeraj is mentioning and to be very specific, at this time we have capacities only for 40 million units. It's safe to assume that a large part of that will be consumed for the early markets that are opening up. And as you know that the early markets that are opening up are only mainly Canada and then Brazil and Saudi Arabia, and of course, a lot of emerging markets. To that extent, we are now very confident that our capacity is very largely sold on the take-or- pay concepts that Neeraj is alluding to. The incremental capacities would, it's a function of us first having the equipments up and running. I think what we are saying is that we believe that the demand is significantly greater than what we had anticipated in terms of timing. And therefore, we are bringing forward the capex and the capacity for 26 technically would be only from that 40 million unit and from 2027 onwards, we'll have a significantly larger number.
If I could make a last one on that, Arun, there's been a lot of this news around the Novo Nordisk cutting the guidance for '26, kind of in '25, and the concerns around the outlook for Semaglutide. And how is -- how are your clients reacted to it? And is there any change the way we're looking at the business side?
We share your concerns, Nitin, but it's just the fact that we are a CDMO and we go by what our customers contract with us, right? And at this time, they are increasing forecasts, willing to pay upfronts, and we can only go by that. We believe that an improved price point, and there is obviously no worse we can't specifically comment on a company, but I think it's also to do with pricing and patients falling off the regime fairly quickly. I think price points, which the generic industry generally does, will enhance the market quite significantly.
Okay. Thank you.
I think to Arun's point exactly, that it's -- what we see is that whatever Novo is talking about in the US is also that they are losing to compounders. So the overall volume is in the US is still getting maintained. And the same that once the generics come in, especially in the markets where -- which are opening up over the next year or so, I think a significant volume driver will be just access. Access to product, which is not there today, will drive and the price delta between Tirzepatide and Sema generic will continue to drive. So we are very confident as our customers are over the next couple of years.
If I can take one last one, after the permission, in the presentation, we talk about nine NCE-1 molecules, barring, so which are these -- what are the timelines for these, for these molecules to be coming in the market? And they, I mean, do they include, how many of GLP-1s are in this NCE-1?
This is a very specific question, how I would just like to say that these are very important opportunities and NCE-1 generally are, they are of various molecules, there are GLPs, there are non-GLPs, there are oral technology, there are injectables, all across all our modalities. And these will start entering the market over the next couple of years. And we'll keep you posted as these come up.
Thank you, sir. Bye.
Thank you. The next question is from the line of Abdulkader Puranwala from ICICI Securities. Please go ahead.
Yes. Hi, sir. Thank you for the opportunity. So first question is on, I know you have the capacity expansion. So you mentioned about expediting the 200 million cartridges by the end of CY '26. So based on today and the kind of outlook from what your customers are giving, is there a plan to further expand this from where we are or where we have committed in terms of the cartridge capacity?
So I think, as you see, right, that this is a moving market, right? What we knew a year back is very different from what we know now, and market continues to evolve. And we are continuously engaged with our customers, as we mentioned, based upon our customer forecast, we have picked, we have advanced our capex program. And if it is required later on, and our customers want, we would be doing that. Arun already mentioned that if the assets especially the one in Poland, if it comes, we do end up closing that position. That's an area where we would be doing our next expansion. So we are open and we are thoroughly engaged with the market development.
Understood. And, sir, in our revenue guidance and EBITDA guidance for FY '28, we are not factoring the Poland and Baroda facilities, what is getting evaluated, is that right?
Yes, that's correct. We have mentioned that $400 million revenue we gave was through organic growth. And if we do end up closing these acquisitions, it will be significant. Arun already mentioned that FY '27 numbers for these will be about $100 million revenue, about 40% EBITDA. So these would add significantly to our guidance. And once it is closed, we will be sharing a revised guidance.
Okay. Understood. And just lastly on your current quarter performance. So if I have to see the current quarter, can you throw some color on how the three segments of the business would have performed?
So, I think as we have said, that all parts of our businesses have performed. Obviously, the drug device combination, a lot of work, we executed a lot of MSAs. So it's always the key driver. But at the same time, our injectable and soft gelatine business also did. Both our base business soft gelatine and injectable have some seasonality built in because as you know, antibiotics are seasonal. Some of the large cold products are seasonal. So, it had some seasonality built in into that part of the business. But let's say all businesses, all our service offerings have delivered basis our expectations.
Thank you. The next question is from the line of Madhav from Fidelity. Please go ahead.
Hi, good morning. Thank you so much for your time. I just wanted to get some more additional views on the commentary that you made about customers significantly revising their guidance upwards for the, I mean, for the Semaglutide supplies. Could you give us some sense in terms of how the volumes could play out in markets like Canada, Brazil, where the innovator was present already? And maybe some of the markets, other EMs where they probably didn't launch or were in early phase of launch as well, like including India. So, and what's changed when you say forecast is higher. So maybe in the last 2 to 3 months since our Q4 call, why are they revising their guidance upwards? Just wanted to get some more feedback. Thank you.
Yes, I think what I would really like to say here is that it's all a matter of access, right? The numbers which you see right now in IQVIA in both Canada, Brazil, and some of the other markets are primarily a factor of supply. It is not a factor of the inherent demand, the patient population, the incidence of diabetes and obesity, which is very significant in these markets. But the numbers have been really constrained by the supplies from Novo. And if we do the right analysis on how the patient population is, we will realize that these markets are really underserved. And with generics coming in, we see the access is what is going to drive the volume. And as whichever market, you see the products coming in, the market's expanding. A very clear example also is India, where moment the product is launched, you see a significant uptake, and we see the same picture in these. And I think on that basis, the customers have increased their forecast.
Got it. And just to follow-up there, if you could maybe give some feedback separately for markets like Canada and Brazil, where innovator was present there, what's your sense on sort of volume in calendar year '24 or '25, how the run rate is, how the volumes could expand as generic opportunity opens up? And maybe if my understanding is right, there are like 80 plus emerging markets where Semaglutide generics can be launched. Could you give a ballpark number in terms of how many of these countries Novo didn't launch itself? So these could be like new markets where generics probably formed the market in the first place. Thank you.
Yes, so to your first point on both Canada and Brazil, while Novo had launched, but again, as I said, the supply had been really constrained. If you know that Novo has really been focused on supplying the markets, which are primarily US and Western Europe. And these markets had very limited supply. I mean, just, we have the 2024 number of total GLP-1s in Canada, for example, at just about 12- 12.5 million. And I think for us, it's clear, and same as Brazil, it's less than half. We see both these markets to be significantly more. And end of the day, obviously, we as CDMO have to follow what our customers say. I mean, our customers are the who's who of the generic industry. And I think there is nobody better than them to really forecast the market. So, we just make sure that our customer demand is met, and we are set to meet that forecast.
Yes, and just a follow-up on the emerging markets where out of the 80 plus countries, where Novo didn't launch itself? Any, very broad number is fine. Like, don't need an exact number, but it's like 30 countries, 40 countries where Novo would have launched?
I don't have, I can come back to the specific data. But I can say that it's many of these markets, Novo didn't launch. I mean, you can have a clear example that the diabetic capital of the world, the second largest diabetic population of the world, India, they launched as recent as a month back, right. So, so many, many markets, they have not launched. We don't have that number, we can come back to you. But market formation in those markets will help and our customers, we have global customers, and global customers have global footprint. So, when we supply to them, it's for our customers to choose which market they would like to supply.
Understood. Thank you.
Thank you. The next question is from the line of Rupesh Tatiya from Shree Rama Managers PMS. Please go ahead.
Thank you. Thank you for the opportunity, sir. And I must appreciate Arun for bringing all the injectable assets in OneSource. So, it's really appreciable and my best wishes for the scheme and the whole process. I have two questions, one on Xbrane and one on Brazil. So, in Brazil, sir, will both Ozempic and Wegovy will be launched in 2026 or Wegovy is a little later? And then are we present at market formation in Brazil? Are we part of Wave 1 launches? And then how is the client concentration in the Brazil? Are we dependent on a single large customer or there are multiple large customers? So, this is the question one on Brazil.
Yes. So, Brazil, obviously, we are seeing both ways, First launch is of Ozempic. But the way the Brazilian patent regime works, they don't normally allow any change, any separate patent expiry for the same molecule. So, it is likely that they will come. But again, that's for our customers to answer and handle. From a customer point of view, I can tell you that we have a large customer base, which includes global customers, regional leaders, country specific leaders. So, we have a fairly diverse customer base. It is true, not only for Brazil, it is true for the whole for the global market. And I think that's where, which is true also for Brazil.
Just clarification, we will be present at market formation in Brazil as well, right?
So, again, if our customers get approval, so we have already said that we, our site got a ANVISA approval. And we are all set, we are all ready from all our approvals point of view. But obviously, it will depend upon our customers' product approval in the market for us to be there, for them to be there at market formation.
Yes, fair enough, sir. And then on Xbrane, sir, I think the press release…
Sorry to interrupt. Mr. Rupesh, may we request you to return to the question queue for a follow- up?
I just asked one. I had one more on Xbrane. So, I think if you can give opportunity.
Please, please go ahead.
Yes. So, what is the quantum of investment, sir, in Xbrane? It wasn't mentioned, I think, in the press release. And then when do we expect the technology transfer process for Ranibizumab to begin? And in which year, can you give some timeline on when can we see some commercialization of this molecule? And then finally, how many more future products this partnership will have? This is a question on Xbrane. Yes.
Yes. So, Rupesh, Xbrane, as I said, it's Swedish biotech, very strong R&D capabilities, very strong pipeline. And with this investment, we have access to their pipeline and the fact that some of the assets which they already have will get transferred. They have assets in -- the products which they manufacture outside could come to us. And the tech transfer, to your question, when the tech transfer will start? I think the, in fact, the process is already initiated. This is a biologics product. It's a pretty long tech transfer process. So, we expect the tech transfer to be completed over the next 12 to 18 months. And that will also trigger our inspection, both from Europeans as well as from FDA.
Okay. But the investment amount, can you give some range, sir, INR 100 crores, INR 50 crores, INR 200 crores, some range, what would be our investment in the Xbrane? Yes.
I think, I don't think that's what we are discussing right now. As I said, the investment is for us to get access and we have a stake in the company. I think we will leave it at that for now.
Okay. Okay. Thank you. Thank you. I'll come back in the queue.
Thank you. The next question is from the line of Rishabh Gang from Sacheti Family Office. Please go ahead.
Thank you for the opportunity. You give a lot of information regarding the acquisition of the two plants. Just wanted to ask, how do we see the return ratios and payback for such acquisition? That's my first question.
So I think, as Arun mentioned, right, we have initiated, the process is just initiated, right? We've just had the Board approval to start the evaluation process. So even now we are going to be engaging bankers for valuation and so on. So, once that is done, I think we will be able to come back to you. If Arun would like to add something. Arun, please.
Yes. Neeraj, thanks. So I think to answer your point, first of all, although we have interests across various companies, you need to appreciate that we will not recommend a transaction unless it meets all the governance criteria. And that is why we have a very robust governance process across group companies to ensure that the minority shareholder interests are of the highest order. We believe that these transactions will be accretive and typically all transactions that we have done should be accretive to the listed company. Like Neeraj mentioned, this is early days. You will have the opportunity to evaluate your question when you see the data that should be available in the next couple of months when all the advisors and the fairness opinion is out. And I think that would be an appropriate time for us to have more pointed questions around that.
Got it. Thank you, sir. The second question was regarding the compounded GLP. Like, if you can tell how big is the compounded GLP market right now? And do we also target this kind of a market, or are customers targeting compounded GLP?
No, compounding is a phenomenon which is unique to the US and few countries in Western Europe. Where -- but how big the size of this market is anybody's guess. Simply because this market, there is no fixed for the molecule. It is whatever molecules are in shortage, the compounders are allowed to compound. That's how the compounding market works. So there is no fixed size of this market. Obviously, because of the huge shortage, which was there in the US both for Novo and for Lilly, they were allowed to compound. And I think at their peak, they were able to get a very significant share, anywhere between 8% to 10% of the total share they were able to take. Now that the FDA has withdrawn or asked them to stop compounding, it's anybody's guess. But I think its important thing is what it shows is that there is very significant demand in the market, which if whether it's Novo or when there are generic launches will come, the patients are all available to take the product.
Got it, sir. Thank you so much.
Thank you. The next question is from the line of Chirag Shah from White Pine Investment Management. Please go ahead.
Yes. Thanks for this opportunity. I got two questions. Question one is on the potential M&A that you are again embarking on. So is it more of the same or it brings the additional capabilities either in terms of technology or in terms of customer? I know you would have -- you have already indicated earlier, but a brief rewind would be helpful. How does it add up to in terms of value to OneSource? Question one. And I'll ask the second question after that.
So, I think I mentioned and Arun also mentioned, these -- if, obviously, if approved, these sites bring in significant strength to our core injectable business. They add multiple capabilities. They add to our existing capabilities. They are very synergistic to the fact that we have our penems add to our antibiotic franchise, which is already there with penicillin. We have a very significant expansion to the US business. The customers are some new and some common, so it increases leverage with them. And a very important point which this covers is that, this acquisition would give us a global footprint, which is very key for a global CDMO like OneSource. And obviously, the Polish site has got huge expansion capability to add our drug device combination suite there to service our both European and American customers.
Okay. The second question was, we have been focusing on generics. Any thought on being part of innovator or what are the challenges over there? And would this Polish acquisition help you to be part of the innovator supply chain? Especially what after the Catalent deal which has happened, you are in a sweet spot in that sense.
Absolutely. Your point you're making is absolutely valid. So, just to say that we already have innovator customers. In fact, we said that in our biologics business, we already have innovator customers with a new biologic entity. So -- and we continue to add. But your point on the Polish entity facilitating addition of innovator customers, especially the ones with the next wave of GLPs, it will really facilitate working with innovators.
Would you like to just call out what part of the revenue, what percentage of revenue would be coming from innovator for Polish? A broad range also would be fine. If you can help us understand, it would be helpful.
So, I think as a CDMO, we really do not look at specifically what kind of customers it is, as long as it is diversified, as long as we have the capability. So, we don't really do this segregation here, but we would be happy in the long-term once the business has stabilized, especially in the biologics field, we would be able to share as we progress.
Okay. Thank you and all the best.
Thank you. The next question is from the line of Suvaan Mittal from MFC. Please go ahead.
Hello, sir. Thank you for the opportunity. I just have one question. In continuation to a previous con call, you had mentioned that we aim to be significant player in high viscous prefilled syringes. So, is these two acquisitions of USFDA facility one of the first steps to create a foundation in the specialty injectables, mainly with a vision of being a significant player in that? And secondly, if we can be a significant player, can we somewhere mirror our growth and scale in DDCs and some 2-3 year perspective on that?
Yes, yes, yes. In continuation to a previous con call, where you had mentioned that we aim to be significant players in the longer term, first of all, to injectables.
Yes. You know that, right, that we have a very long legacy in the group to be a strong sterile injectable player. And these sites which come in, they both, they supplement our capabilities and complement capabilities which we don't have. And whether it's in the area of ampules, an area which we don't have right now in OneSource, to the area of a very large manufacturing of vials. Again, it increases our scale of manufacturing at multiple times because of very large capacities which are there, especially in the Polish site, pre-filled syringes get added. So, both, as I said, complementary to what we do and adds capacity to what we are doing. And the very fact that there are significant more, I mean, we all know everybody follows the patent expiries which are coming over the next 5-6 years in biologics. We also need to look at the significant number of patent expiries coming in the field of sterile injectables. So, we are and want to remain a very significant CDMO partner in this area of injectables and this acquisition will strengthen our game there.
Thank you. The next question is from the line of Mehul Panjwani from 40 cents. Please go ahead.
Hello, sir. Thank you so much for the opportunity. Sir, I have one question I have is about the commentary you mentioned that the revenues will pick up from the second half of the year. And also you mentioned about Q4, there'll be a lot of pickups by the customers. So, can you please elaborate. I am new to the company.
Yes, I think it's what we just mentioned that, our first half is about executing our MSAs in our drug device combination business and readiness for commercial manufacturing and launches. And we will be manufacturing, we have got confirmed purchase orders from a number of customers and the manufacturing will be done in the second half. And as the approvals come in and as the patent expires, that's how the revenues will start coming in from the second half from all the Semaglutide launch.
Thank you. The next question is from the line of Dhruv Gupta from Sagun Capital. Please go ahead.
Yes, hi. Thank you for taking my question. My question was beyond GLP-1, are there any other therapeutic areas or delivery platforms where you see potential for platform expansion?
Yes, absolutely. So, I think I have mentioned earlier in previous earnings calls that our strength in OneSource is drug device combinations, right? So, and products which -- where there is an interface between drug and device. And that's what is key. We have got today 10 different molecules in the drug device combination, which we are working for our customers. And only three of these molecules are GLPs. So, you can imagine that there is a very large expertise which we have. We have expertise in filling drug device combination, in assembling them end-to-end. And now you see most of or a lot of new R&D and products getting approved are in the area of self-administration. And self- administration is really supported by drug device combination. And you see products which we, our first product approved in US for our customer is a non- GLP drug device combination. Our first product approved in Europe is a product which is a drug device combination in biosimilar area. So, we are always working on various products in drug device combination outside of GLPs. And outside of drug device combination, our very strong business both in sterile injectable and the soft gelatine is really -- strengthens our core base.
Thank you. The last question for the day is from the line of Aman Vij from Astute Investment Management. Please go ahead.
Yes. Good morning. Two questions. One is on our two products, Liraglutide and Teriparatide. We were supposed to launch these products in Europe for a while now. Can you talk about the revised timelines? Do we expect this quarter it will take two, three more quarters? And what is causing this delay? That is question number one.
Yes. So, Liraglutide already you said our customers have got approvals. It's also CDMO is not always dependent upon one side. It's both dependent on customers and customer priorities and customer's ability to supply us all the material, because our job here is to manufacture as per customer's requirement and also customer's priorities, right? So, it's key for that. So, that's what I would say. Having said that, Liraglutide for Europe, we have already manufactured this quarter. And our customer will be launching the product and Teriparatide is exactly the same. In fact, we've already manufactured for our customers and it all, the actual launch will depend upon, again, as I said, customer's options and when they want to launch.
So, is it expected in, say, first half of this year or next second half of this year, both the launches?
So, we have, both -- in fact, we have both for us. For us, both the products have been manufactured. And as far as OneSource is concerned the launch will be in first half.
Sure, sir. My second and final question is on the GLP-1 market. So, could you talk about how important is India market according to you for us utilizing that, say, 40 million and 100 million, at least the 100 million fill finish capacity we have? Do you think Indian market can be, like, as big as Canada or Brazil market or it will be much smaller market? And just to complete this thought, do you think at least for next 1-2 years, given we are present with almost most of the customers who are launching in India, Brazil, even Canada, do we expect we will have almost like 40%-50% kind of market share in Semaglutide generics in the next 2 years?
Okay. So, on India, so, if you see, obviously, at the face of it, India is the second largest diabetic population in the world. So, there is a very, very strong inherent demand, which is there. Now, whether we will supply or, for us, it all depends upon our customers. We have global customers, and if India is their market, they would launch. We, as a CDMO, are completely geography agnostic, right? It doesn't matter. We will supply. We have agreements with the customer, and they decide where -- whichever market they want to supply. So, I cannot really say whether they will supply or not to India, but, yes, we are open, and we are open to supply in all markets. To your question on our shares, we have really global who's who of generic companies, whether it is the global leaders, the regional leaders, leaders in specific large markets, and I don't know what next 2 years, but in steady state, if we see looking at our customer base, it could be anywhere up to a third, at least, of the generic market as it develops, could be serviced by the customer segment, which we have.
Sure, sir. Thank you for answering the question.
Thank you. Ladies and gentlemen, that was the last question for the day. I would now like to hand the conference over to the management for closing comments.
Thank you. I really, on behalf of OneSource, really would like to thank you for the interest and for all the questions, very insightful questions, which have been asked. And I know it's never enough. We are never able to take everybody's questions, but we really would like to ask you if you have questions to reach out to our Investor Relations team on our website, and we'll be very happy to respond and answer your questions. Thank you, once again, for being with us this morning.
Thank you.
Thank you. On behalf of OneSource Specialty Pharma Limited, that concludes this conference. Thank you for joining us and you may now disconnect your lines.