Ladies and gentlemen, good day, and welcome to the Orchid Pharma Limited Q1 FY25 earnings conference call, hosted by Systematix Institutional Equities. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Vishal Manchanda from Systematix Institutional Equities. Over to you, sir.
Thank you, Deepika. Good evening, everyone. On behalf of Systematix Institutional Equities, I welcome you to the Q1 FY25 earnings call of Orchid Pharma. We thank the Orchid Pharma management for giving us an opportunity to host the call today. We have with us the senior management of the company, represented by Mr. Manish Dhanuka, Managing Director, Mr. Mridul Dhanuka, Full-time Director, and Mr. Sunil Kumar Gupta, the Financial Officer. I'll now hand over the call to the management for opening remarks. Over to you, sir.
Thank you, Vishal. Good evening, ladies and gentlemen. I'm Manish Dhanuka, the Managing Director. I'm pleased to welcome you to our discussion on the results for the Q1 of FY 2025. First, let's review the financial performance for Q1 25. I'm pleased to report that our sales for this quarter reached INR 244 crore, a robust 34% increase compared to INR 182.9 crore in the same period last year. This growth is a testament to our strategic initiatives and our commitment to delivering value. Our overall EBITDA for the Q1 25 was INR 41 crore, a substantial increase of 71% compared to INR 24 crore in Q1 of FY 2024. This improvement reflects our continued efforts to optimize operational efficiency and control costs.
After analysis of our expenses, I am pleased to report that our employee expenses have remained steady at 8.7% of sales in Q1 2025, compared to 8.8% in Q1 2024. Regarding the other expenses, these have been well controlled, just like the other expenses, standing at 16% of sales in Q1 2025, compared to 17.7% in Q1 of 2024. This reduction is a result of our continuous focus on streamlining operations, reducing non-essential spending, and improving productivity and efficiency. Now moving on to our operational updates. I'm excited to announce that we are ready to launch Orblicef, O-R-B-L-I-C-E-F, our brand name for enmetazobactam plus Cefixime combination, which stands as Orchid invented beta-lactamase inhibitor plus cefepime.
We are confident that this product will make a significant impact in the market, and to augment its reach, we have signed a marketing agreement with Cipla. This partnership will ensure that Orblicef reaches a broad audience and achieves its full market potential. Regarding our ongoing projects, I'm pleased to report that the land acquisition for our 7-ACA project is complete. We are planning to break ground on this project on the auspicious day of Ganesh Chaturthi. Also pleased to inform that we have obtained our NOC registration for the GST benefit in J&K, which has come at the right time, as the scheme has now got closed. This is a significant milestone for us, and we are excited to take this important project forward. Our small capacity V-GIP that was discussed during the last call is progressing ahead of schedule.
We have already started trial runs, and we anticipate completing the commissioning by the end of this month. This will provide us with the necessary capacity to support our growth and meet the increasing demand of our products. Other projects in our pipeline are also progressing as per schedule, and at this time, we do not foresee any major challenges. These developments reinforce the importance of our continued focus on project management. Effective project management is critical to our success, ensuring that we meet our timelines, stay within budget, and deliver high quality outcomes that drive our business forward. Looking to the future, I'm filled with optimism. The strong financial results we have achieved in Q1, combined with our progress on key projects and strategic partnerships, positions Orchid Pharma Limited for a sustained success and growth.
Our focus on operational excellence and disciplined execution will continue to guide us as we navigate the opportunities and challenges ahead. In conclusion, I would like to express my heartfelt gratitude to all our stakeholders, employees, investors, and partners for your unwavering support and trust in Orchid Pharma. Together, we will continue to build on our successes and achieve new heights in the coming years. Thank you for your attention. I now welcome your questions and look forward to a productive discussion.
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 touch tone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use handsets while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. The first question is from the line of Ahmed Madha from Unifi Capital. Please go ahead.
Thanks for the opportunity, and congratulations on the good set of numbers. I had two questions. First, on the Allecra, have we finalized, I mean, has the Allecra finalized the partner for US and China? And second is whether the royalties from the Europe market, when will we start booking the numbers on PNL?
Yeah, Ahmed. On the China front, whatever is in the public domain is they have out-licensed to a company called Shanghai Haili Pharmaceuticals in 2020. And in U.S. market, we are not aware of any new development. As we have explained before, Allecra is a company which, whenever they do something, they put it in public domain, and that's how we find out about it. So that's on U.S. and China. On Europe, our expectation is we should be looking at, booking the first sales, in this quarter. I don't have a timeline yet to give you the numbers, but hopefully by the time of the next conference call, we would have the first sales numbers to report.
Noted. Any update on the US Para IV filings? We had a couple of filings for US, for Para IV. So is there any update on that, on the timelines?
Yeah. So we have filed on the due date, and now we have to wait and see. It's a 30-month stay on that, and the actual launch can only happen, even if we get the first to file status, by August of 2027. So the filing has been done on due date.
Okay. No, thank you. Thank you, that's from my side.
Thank you very much. Participants who wish to ask question may please press star and one at this time. The next question is from the line of Rupesh Tatiya from Intelsense Capital. Please go ahead.
Hello, sir. Can you hear me?
Yes, sir, you're audible.
Okay. Thank you. Congratulations on fantastic set of numbers, sir. I have few questions. So first one, first question, sir, is on the cephalosporin capacity in India. One of the, you know, recently listed player is talking about putting up a capacity in cephalosporin. One of the small listed companies also, you know, doing some CapEx in cephalosporin. So how, what is your, you know, view on capacity, and do you are you seeing, you know, increased competition in the market?
Yeah. So I'm really not aware about the news that you're talking, who is investing in the capacity. But my take on this subject is that, yes, the field is competitive, although Orchid is relatively well-positioned to have a wide range of products, especially in the injectables field, and there are not many players who manufacture half as many products in injectables as we do. At the same time, I'd like to say that the demand is continuously growing from various regions which are not so well, I would say, utilizing the cephalosporins, which are still on the first generation of beta-lactams. So overall, I don't see much of a challenge. Yes, but we do have competition in this field.
Okay. Okay, sir. The other question, sir, is we were, you know... I think when we were talking with Allecra, only I think the CEO level, kind of, like, connect was established, which I think you said in the last call, and then, you know, teams down the ladder, I think they were looking, we were looking at a deeper engagement and better tracking and all that. So has that kind of happened, and is there, you know, any sales projection or some planning that you are aware of that Allecra is planning for in markets for Exblifep in this year and next year?
Unfortunately, they have not shared any sales predictions for the coming years. Considering the three-year plan, I think that would be relevant only after once they launch and see the actual traction in the market. Unfortunately, no news there.
But the communication channels now are firmly established. Is that fair to say?
Yes, that's fair to say. We are regularly in communication with them.
Okay, sir. The other thing, sir, is this Cipla deal in India. I mean, can you share, you know, any details on, let's say, gross profit sharing? Any which way you want to share.
Yeah. I can't share the numbers, but the deal is structured like a typical out-licensing deal, which will have a transfer price and some royalty.
So my fear here, sir, is that we're dealing with a very large company who has a very massive distribution, but yet you are the innovator. It's an 80% gross margin product, so my fear is that we might have, you know, given too much to them and not get enough for Orchid. So maybe can you address that in some way?
Actually, we are bound by the confidentiality of the agreement, but I mean, I can assure you we've done our best and, you know, used our best negotiation skill. I think Cipla is probably one of the most reasonable and professionally run organizations among the large pharma companies. We felt very comfortable, you know, dealing with them, and they've been very reasonable with us. We do get a licensing fee, or in the form of royalties, and we get the right to supply exclusively to them.
Okay. Okay, okay, sir. And, and then, between Cipla and your AMS division, and, and I think we're looking for a launch in Enmetazobactam pretty soon. Do you have some guidance to give for India, India market for FY25?
Yeah. So we have retained the right to market ourselves as Orchid Pharma. So besides Cipla, Orchid Pharma will also be marketing the product. And Orblicef that I mentioned will be our brand name. Cipla will have different brand names. So through AMS, I think this is a great launch opportunity for us that we will be entering the market with a new molecule, and our team seems to be very excited about it.
But can we do, let's say, INR 100 crore kind of sales for this year?
No, no, I think that will be very aggressive. We are starting with a small team of about 40 to 50 people, and, we are projecting, we have talked about a guidance of three to, in 3 to 4 years, INR 100 crore for the AMS division. So that is already we have talked about, we're maintaining the same number.
Okay. Okay.
Yeah.
Okay, so other question is now on the full call, I mean, is there an update on CapEx? Can you give how much amount is spent, where are we on CapEx?
Yeah. So we, we've applied for the approvals over there, and I think we should start the construction there. The groundbreaking ceremony has been done. We should be starting construction in the month of September. So overall, I think, we are, we're looking at, you know, project being commissioned sometime around 2026, early 2026.
So $15 million, I think, was the CapEx outlay. So what kind of amount are we looking to spend this year, and what kind of amount we are looking to spend next year?
I think the amount to spend during this financial year would be relatively less, say, about one-third, and maximum investment will go in during the next financial year.
Okay. Okay. I see. So, 7-ACA also, can you give the similar what kind of CapEx we'll spend this year, what kind of CapEx we'll spend next year, and when will we be ready for, you know, trial commercialization on 7-ACA?
For 7-ACA, CapEx has already started happening in the form of advances to various equipment manufacturer. And by end of this year, we anticipate a similar number of, you know, 30% to be spent, and most of the CapEx will happen in next year, next financial year.
Can you give absolute numbers, sir? 30% is what, INR 250 crore this year?
Yeah, around 200, INR 150 to INR 200 crore would be the right number.
This year. Okay. And, and INR 400 crore to INR 500 crore next year?
Correct.
Okay. Any update on the Dhanuka merger, sir? Any timelines, what steps are pending? When would the Dhanuka merger be done?
We're still waiting to hear from the exchanges on that. Fingers crossed. Unfortunately, no update.
Okay. Okay, but this year, at least by March, will it be done? Is that reasonable-
I can't say in the regulatory process, as you are aware, the application form filed in December last year for approval with exchanges, and it's been 8 months. You can't say how much time it's going to take.
Okay. Okay, sir. And then the final question from my side is any, any, I mean, any update on business development in U.S.? Is there some update there, or how would this year look and next year look from U.S. point of view?
Like we said last time, one of our main customers lost its own US FDA. So working with a couple of other customers, and the timeline, I don't think I can give you at this point of time, as they would be filing, you know, the source change. So it would be difficult for us to comment on the timeline.
Okay. Okay, sir. I'll, I'll get back in the queue. Thank you. Thank you for answering my question.
Thank you very much. The next question is from the line of Nikhil Upadhyay from SIMPL. Please go ahead.
Yeah, hi. Good evening. I'm audible?
Yes, sir, you're audible.
Yeah, hi. Congrats, Mridul and Manish , for a great set of numbers. Mridul, just understanding these numbers better, if I go back two quarters back, we had two smaller capacities which were coming, one on the sterile and one on the oral. Is it like those capacities commissioning has supported this kind of a growth? If you can just help us understand, what led to this strong growth? And overall, what would be our capacity utilization, both on sterile and oral?
Yeah. So on the sterile, the block is commissioned already, and the new sterile block is roughly 50%. And the oral block, we did like, Mr. Manish explained in his opening remarks, that is going ahead as per schedule. Right now, not yet commissioned.
So currently, our overall capacities at this stage are, you can say, almost fully utilized. We are at almost 90% utilization.
Okay. So is it like this, part of, like, this 50% utilization of the sterile has had, given this strong volume growth? And is there a pricing element also here, or is it purely volume growth?
You can say mostly it is volume, although product mix also plays a lot in our overall sales, because we sell almost this 40 products. So it would not be possible to say how much is volume, how much is pricing. I don't think prices have changed.
Okay. Okay. And, secondly, so on some of the product launches in U.S., which we were talking about in previous discussions, are you seeing any approvals coming in, or would they come in this year, or would most of that be next year?
Yeah, just as Rupesh was also asking this question just before you, and Mr. Manish had explained that our, you know, the largest possible customer had a U.S. FDA issue last year, and since then, we are exploring certain opportunities, but we don't have visibility of any of them as of now.
Okay. And lastly, if you can just share the break-up between regulated and non-regulated markets in terms of revenue split.
Yeah. So even in this quarter, the percentage remains as per our long-term trend at 60% regulated markets and, sorry, 60% emerging markets and 40% regulated markets.
Okay, so when do we see this shift meaningfully changing? Because in last two, three years, we've been adding new customers on the Europe and all, but is it like they are still not contributing significantly? What is the., What is taking this time, this ac-, what is creating this delay? If you can just help us, or my understanding is wrong here.
No, no, Nikhil, we have never said that this number is going to change. And as the things stand, the volume growth largely is going to happen in the emerging markets only. So we have never said that, the share of the regulated markets is going to increase. In fact, if at all, it is going to be, may fall as the volumes in emerging markets increase. So we have never said this is going to increase, so maybe there is some understanding there when you are expecting that increase.
Sure. Okay, fine. Thanks, I'll come back in this.
Thank you very much. Before we take the next question, we would like to remind participants that you may press star and one to ask a question. To ask a question, please press star and one now. The next question is from the line of Yash, Yash Shah from Abans. Please go ahead, sir.
Hello, sir. Thank you for the good set of numbers. There are a few queries that I would like to ask. So you have mentioned that you have sterile capacity that was already commissioned, so what is the status of that? Is the production in the capacity has started? And there were some trial runs and checks also going, so can you give us an update on that? What has happened there?
Yeah. On the trial product, I just explained we are at 50% utilization for the new block. The older blocks are at practically full utilization. I did not understand the next part of your question. For which trial?
You said you can only sell the products in the developed market, sorry, in the emerging markets now. There would not be. You would have to undergo some trials for it to be applicable to be sold in US and Europe. Hello?
I'm sorry, I'm not able to understand for which product you're talking about.
Okay. And sir, what is the update on overall capacity? Is it, it is, it was about to complete in the Q2 of FY25. So is there any update?
It is going as per schedule. We are already undergoing water trial, and it will be commissioned within this quarter.
Okay, and we can expect the utilization starting in 2025, in this current financial year only?
Yes. From next quarter, it should start generating revenue. That means the October quarter.
Okay. And sir, there is some query regarding Cefovecin also. So could you just give an understanding of the market size that we can expect from this drug?
You're talking about India, or which market you are talking about?
I'm talking about Cefovecin.
Yeah. For which market, India or US?
For India. For India.
India. We don't have any plans as of now for India. It's a very expensive product. We are yet to evaluate what is the sales potential in India.
Okay.
Just for your reference, yes, this is a medicine for companion animals, mostly dogs, and one injection would cost typically INR 100,000. So at this price point-
Okay.
We don't imagine they're going to be a market in India.
Okay, sir. Yeah, that makes sense. Thanks, sir. My last question is about Cefiderocol injection. So any idea about the cost of production that you will be having? If you can give us a broad idea.
The cost of production?
Yes.
No, unfortunately, that is going to be secret or confidential. What we can tell you is that the current cost of therapy in US market and other regulated markets is about INR 10 lakh a patient. And when we make in India, our target will be to at least reduce it by 50% to 60%, if not more.
Okay, and your deal is, your cost plus 20%?
Cost plus 25%, and this is, 25% is there at a PBT level.
And this is-
Depreciation and interest cost.
Okay, so it should be close to around 50. You'll be selling it at around 60%, and from the cost at which it's available in U.S., approximately. Is it a fair assumption?
I think 40% would be a fairer assumption than 60%.
Okay, so the cost of the drug would be 40% for the end consumer?
Yeah, you can, you can think like that. That's what target is, but right now it is not developed, so it is only a, you can say, a guesstimate.
Okay. And, sir, we can expect the sales from March 27?
Yeah.
Hello?
Yeah, yeah. So, yeah, before March 2027, we should expect it.
Only, I mean, we can't say about the regulatory hurdle, but I think commercially we should be ready much before then.
So since the product is registered in India, so we just have to navigate that aspect. But yes, March 2027, in that year, we should see definitely sales.
Okay, sir. And, are we looking at other countries also, apart from India, for sales of Cefepime? And apart from India, are we looking at Bangladesh and other neighboring countries?
See, the license has been given for 135 low-income country, so the manufacturing is being done for the entire world, which includes 135 countries, and where Shionogi will not be present itself. So we will probably be selling across the world, but the commercial rights of that lie with GARDP, and they will decide on who the end customer will be.
Having said that, two-thirds of the market is expected to be India.
Okay, sir. Yeah, that's all from my side. Thank you, sir.
Thank you.
Thank you very much. The next question is from the line of Viraj Kacharia from Carnelian Asset Management. Please go ahead.
Hi, Nikhil. Hi, Manish. Congratulations on good set of numbers. And also congratulations on finally having the land acquired, Jammu and Kashmir for 7-ACA. The first line, first question is on those lines. We earlier spoke that it'll take 15 to 18 months from the time we, you know, break ground there for the facility to commercialize. So is it fair to say by FY 2027, the year of FY 2027, we will see, you know, the facility getting commissioned? And what will be the capacity utilization of the facility in the first year and the second year?
Yeah. So, the timeline you have mentioned is correct. In the last call, we talked about commissioning by April or so, 2026, and after that there would be trials and commercial production will start. So our endeavor would be to run the capacity, you know, the plant at full capacity from the beginning, and the stabilization that stage would be six months. So what you can expect is from FY 2027, sorry, FY 2028, it will be 100% utilization. Although in the last quarter of FY 2027 also we can expect for three months, 100% utilization.
Great. My second question is on the newly commissioned sterile block, which we, you know, have the 50% capacity utilization. Is my opinion right that we don't., we are not selling in regulated markets from that block since we need to have some kind of approvals and that may take 1 to 2 years' time? That 50% capacity utilization in the new sterile block is currently being supplied to emerging markets and not regulated markets.
That's correct. That's correct.
So, how is that data split is still 60/40. I think that it should be tilted more towards emerging markets, right? If we are getting the additional-
Yeah, 60% emerging markets, 40% regulated markets.
Nikhil, my question is that, isn't, shouldn't it tilt to be more towards emerging now? Because we'll have more supply towards the emerging markets from the new capacity.
Yeah. So when we said 60/40, we meant the total sales. So the sales of oral products that we are selling to regulated markets, that has increased in last two, three quarters.
Okay, so oral share has increased in the regulated markets, hence the-
Yes.
Its balance is 60/40.
Right. Yeah. The oral sales of Cefepime and efavirenz to regulated market has increased.
All right. Thank you so much. All the best. I'll get back in queue.
Thank you.
Thank you very much. The next question is from the line of Neeraj from DAM Capital. Please go ahead.
Yeah, hello. Thanks for the opportunity. I joined a bit late, so I'm sorry if the questions were answered previously. Any status on the royalty? Can we expect this to flow in from quarter two of this financial year?
Yeah, we can expect some royalty in Q2, although the numbers and the forecasts are not with us yet.
Understood. This will, as you mentioned in your previous call, there will be a one-quarter lag, right? So whatever we get in Q2, those sales would have happened in Q1, correct? So there is a one-quarter lag here.
our current expectation is that we should be able to report the numbers in the same quarter. The cash will come with one quarter lag.
Okay. Understood. Understood. My second question was, you know, around in your, in your earlier comments, you mentioned about our US partner having some FDA issues. Again, it's a very basic question. The manufacturing would be done by us, right? So, like, so what's the issue over there if the US partner is having some FDA issues? Because we are FDA cleared, right?
Yeah, yeah. So we are the API side. Our US, the customer has a formulation side who buys API from us. So since their side cannot make any product for the US market, therefore, we do not have a customer for. We cannot sell to the US market directly our API. So we have to sell to a company which makes the formulation or what we call FDF.
Understood. That part is, so and as of now, we don't have any visibility on this partner, you know, when their plant will get cleared?
Unfortunately, no.
Okay, understood. Thank you so much. Those were my only questions. Thank you so much. All the best.
Thank you very much. The next question is from the line of Aashita Jain from Nuvama Institutional Equities. Please go ahead.
Hi, good day, everyone. Congrats on the good set of numbers. We have a couple of questions here. Firstly, just looking at the Q1 numbers, the growth looks very strong. Is it possible that for the full year, we can maybe do 25% plus kind of revenue INR 100 for this fiscal?
That would be blissful, Aashita, although we would very much like it for it to be, but this would be moderated. Even if you look at last year, you know, Q1 number, it was almost a similar number growth, but this would be moderated by the end of the year. And our long-term guidance for full year remains the same, 20% or 25%, somewhere in between. So this will be moderated.
Okay, okay. Is it possible to share contribution from Avycaz to the current revenue? I believe we've launched in India in some of the years. So is it a big contributor to our revenue?
It would be difficult to quantify the numbers. That's a confidential information.
Any percentage points or, any direction you are willing to give?
Percentage with the, multiplied with the revenue gives you the number, right?
Okay.
In terms of value, it would not be wrong. That's a small-
It's not in the top three or four products, that I can tell you.
That's a small product, a relatively new product, so.
Understood. And, could you help us with this overall and sterile, revenue breakdown for this quarter?
Yeah, that's similar. 1/3, 2/3. So when I say 1/3, 2/3, ±3 to 4 percentage points, I'm just, you know, not counting. So you can say that 70% is overall and 30% is sterile.
Oh, okay. Okay. And, and just lastly, when you said you have filed on due date and thirty months day, I believe this was for Avycaz in the US.
Yes.
What's the update on Ceftolozane?
Ceftolozane, we are actually trying to first discuss with the marketing partner and finalize our strategy on whether we want to go alone or tie up with somebody. As we explained earlier, for U.S., we wanted to file on our own for Avycaz, but Ceftolozane, we have not taken that call yet. Maybe by end of this year, we will decide that.
Okay. Okay. This is the., That's all from my side. Thank you so much.
Thank you very much. The next question is from the line of Divya Sethi from Electrum, Electrum PMS. Please go ahead.
Hi, sir. Congratulations on the set of numbers. So while most of my questions are answered, I just wanted to understand the market potential of this new drug, Enmetazobactam. If you could give some insights on how big that market is, considering it's a novel drug, or also the breakup between India and the global markets, what exactly would be the potential for this one?
That's a very tricky question, Divya. So I'm not sure in the terms of potential, the product has very, very large potential. And just to give you some sense of the potential, this product is directly compared to Piperacillin/Tazobactam. And at patent expiry, Piperacillin/Tazobactam was a billion-dollar product just for the U.S. market. Our estimations are $200 million to 300 million annual global sales over the patent life, or so $2 billion to 3 billion of patent life sales across the globe. So now potential could be more, less, I'm not sure.
Understood. So you're saying $200 million to 300 million annual sales is what we are expecting, I mean, that is the potential for this?
Yeah, and that's an average number. So in that, we hope to reach the, this number in three years or something like that.
Got it. Roughly around 6% to 8% would be the royalty that Orchid would be getting from. All right. Thank you, sir.
Thank you.
Thank you very much. The next question is from the line of Rupesh Tatiya, Intelsense Capital. Please go ahead.
Thank you. Thank you for the follow-up opportunity. I have several follow-up and clarifications. So first, sir, is, I think Orchid Pharma, recently there was a media interaction. The CEO, I think, gave an interview, and then he said that in AMS division, we are expecting INR 300 crore kind of sales in two, three years. So two questions there: What kind of, you know, margin, do you have some view on what kind of margins we'll make? Because that's a distribution sort of business. That is one. And then have we, you know, are all the teams in the place, hiring is done? And are the costs in the P&L? Because sequentially, I see that employee expenses have gone up.
Yeah, Ritesh, you've captured that correctly. So first thing is the team is in place for the first phase of launch. We should be launching within next month or so. The team is ready for this phase. Over the next few years, we'll be ramping up the team based on, you know, how much success we get actually. And in terms of the numbers, yes, it's already built into the, you know, numbers that you see, and currently, it's EBITDA drag of about INR 1.5 crore. And on the last question, when you said INR 300 crore, I think there is some understanding gap. It's INR 100 crore in 3 to 4 years is our target.
Okay. But what, I mean, any view on margins, sir? It would be like 25%-
It's a new space for us. Right now, I would not like to put a stake in the ground and give you a number on the margin. But yes, it has to be profitable business by itself.
Okay. Okay.
Yeah.
So the second clarification for you is there any one-off in Q1, I mean, in terms of, you know, shipping schedule or some one-off? Because generally we are H2 heavy, Q3, Q4 heavy, and then this time, Q1, I think, is larger than Q4 of last year. So that's if I consider these three factors, I think we're looking at a significant growth this year, so.
Yeah. So what you are seeing is, if you see, you know, our presentation also, which we have uploaded, what happened was Q3, Q4 typically have been heavier. What we have been focusing on how to utilize our capacities in Q1 and Q2 may be better. What you are seeing now is, you know, a result of practically full utilization, and therefore, to an earlier question I had answered, we do not expect this 34% to 35% kind of number for the full year. We continue to expect that 20% to 25% number for the full year basis. So this is going to moderate as we go ahead.
So then my next question, the follow-up to that is for CapEx, because I think previously you have been saying that current, whatever this capacity we did, we are doing, with that, we can grow at, you know, 20% for two, three years. But now you are saying that in Q1 we are at full capacity, and then I think the rejig is coming end of the month. But then you have to look at some CapEx now in the base business, right?
Yeah. So, when, when I said full utilization, I do not, I'm not talking about the capacity rejig that we are doing for the oral business, which will come online by, you know, end of this quarter. And the capacity utilization on the new sterile block is also, only half. So those are the things which are going to contribute for next year or so more. And after that, you will have the other optionalities of the 7-ACA downstream and other things kicking into Orchid. So for this, business, we will also contribute going forward. So right now, no more CapEx on the sterile and oral side business of the existing business.
So, is there some capacity? I mean, if it comes that we need capacity and demand is so strong, is there some capacity at Dhanuka level that we can use?
You are talking, so for the next year or so, I don't think we need anything. And based on our downstream plan, we will talk about more CapEx maybe next year. I think it is a little early to talk about when so much CapEx is going on. We have some plans. Rest assured, we will not stop our growth after this.
Okay. Okay. And then the other sort of clarification is this. You said there was., I mean, even if this first file goes through, the launch will be FY 2027. Is that Avibactam you are talking about?
Yes, and I said August 2027, which will be FY 2028.
Gotcha. So even if we get the FTF, it will be FY 2028 launch. Okay.
That's right.
Okay. And then this Cefovecin, this veterinary product, I mean, India, obviously there is no market, but is there like a plan forward in U.S. or some of the European markets? Cefovecin.
Yeah, the plan is for the U.S. market only. Our team is currently studying and comparing our product with the innovator. We are trying to understand the stability, and once they are confident, we will go for the validation and file.
Okay. Okay. And then I think final two from my side. So one is what would be domestic and export split in Q1?
Roughly, domestic business is around 20%.
Sorry, 20%, did you say?
Yeah, 20%.
Okay. Okay. And sir, I mean, obviously, Avibactam, you don't want to give absolute numbers, but in terms of its potential, I think it's one of the very, you know, good products, successful products, if you look at the history. So would that product grow at, you know, 50% high for next two, three years on a small base?
Yeah, definitely. I mean, I'm expecting a better growth even for Avibactam, because currently we have just explored the potential of Indian market, and a lot of our formulation customers in India are using our product to file for their formulation exports. In addition to that, we are also filing in other emerging markets for this product, you know, with various of our overseas customers. So I feel tremendous. I feel there is tremendous growth potential for this particular product in next two, three years. Okay. Okay, sir. And then just maybe just clarification, Orblicef you said is already at 90% capacity utilization?
Of the existing one. The new sterile block when comes online, this number would drop.
But it was very low, right? I think in last one or two years calls, it has gone to 90%-
Yeah, two years ago, it was like that, and we have been consistently working to improve that. And if you see from Q1 2024 to Q1 2025, a large part of that is contributed to from the oral capacity utilization, and a small part of that is from the sterile, roughly 40% to 50% of the new block.
This 90% would drop to what after the new capacity comes online, rated capacity comes online?
I have not calculated that number, so-
But in ballpark, 50%?
Maybe 70% or something like that.
Okay. So that plus this 50% of injectable takes care for us for one year. Okay.
Yes.
Okay. Thank you. Thank you for answering my questions.
Thank you.
Thank you very much. The next question is from the line of Varun Bang, from Bandhan AMC. Please go ahead.
Yeah, thanks for the opportunity. So lately, we had planned, we had plan of capturing the industry of the business from some of the old customers. So how much of that has been captured? How do you see progress here?
Yeah, Varun, you're talking about our initial plan, which we had shared in the first conference-
Yes
call of this company almost three years ago.
Yes.
So, you know, some of that was old business was supposed to be in U.S., and at that time, we were not aware, you know, of this customer going to, a U.S. FDA status. So I can't put a number to that effect, but I can say that part of the acquisition of old customers is complete.
Okay. Okay. And, secondly, on Orbion, how do you see your remaining stake, 26% stake in Orbion? What is your plan there?
So, we are only a financial investor as of now, and we are talking to them that, you know, if they want to buy back the stake. Currently we are exploring that, but, maybe we'll know in a few quarters what are their thoughts around it.
So largely we plan to exit from Orbion.
Y- Yes.
Sure. And how do you see your relationship with Allecra? I mean, are there any areas where you think there is limited clarity or there is ambiguity? Just want to be across from you.
I would call the relationship to be a very good relationship as of now. But the only thing is that, what we don't get is anything, which is not in public domain, so no inside information is available to us in advance. Whatever they announce, whatever are the plans, we discuss them, but there is no information which is available to us, not in public domain.
So there is nothing that is, no areas where we have limited clarity or there is any, any ambiguity?
No, no. No confusion areas, no areas like that. In fact, they have supported us significantly with data and other things for the product to get a clinical trial waiver in India. So they have been very helpful.
You see, the Europeans, they go strictly by the agreement. So whatever part of the agreement, we are able to get all that information from them without any problem, but they don't go out of the agreement and give us any extra information.
Yeah. Understood. And how would you look to use essentially cash flows which will receive from Allecra? How should we think about directionally? Yeah, your thoughts on this, please.
You're talking about the deployment plan?
Yes.
Yeah. I think, since, you know, once the launch happens, we are more aware of the cash flow more reliably, that's when we'll come up with the plan for investment. Although the Cefiderocol project is right now planned to be funded internally, one way could be to use the cash there. But without visibility on the cash flow, it's difficult to share a plan.
Got it. Okay. Thank you.
Thank you.
Thank you very much. The next question is from the line of Ganesh Rao from Rupani Capital. Please go ahead.
Thank you for the opportunity. I have a couple of questions. First is, we plan to sell our product in collaboration with Cipla, and you just mentioned, we'd also be selling it in parallel with them using our own brand. What kind of margins would we be expecting on that? Would you be able to disclose that?
Hello. You see, it is, it is very important for us when we launch a product, in the antibiotic range in India, to be competitive. So we have kept the price of the product, which is in the same range as other therapies available to the clinician. So, I would say that considering these factors, the margins are, I would say, higher than what any generic product has. But you, one should not expect them to be extraordinarily high. Although without giving the actual number, I would say it's a, it's a very good, profit margin business, I think.
Thank you, sir. That, that's helpful. The second question that I have is, recently, Allecra had announced that, they had signed agreements with, the Gulf Council and South Africa. By any chance, do you know what kind of an opportunity set that is, and how much would it translate for us?
Unfortunately, those numbers are not available with us, but that should only contribute positively to our estimate.
Okay. So, and this is probably a basic question: so when they do sign agreements, as they've been stating, they don't disclose this to you, but once that agreement happens, eventually you would get to know what kind of volumes it would be, so that you can expect and calculate on the royalties, right? And what kind of timelines would that typically be?
You know, so we don't have the financial parts in the agreement. What we are only entitled to is a post-facto reporting of the sales and our expected royalty from that.
Okay, sir. One last question, this is just for clarification for me. You said that for Cefiderocol, we don't, you know, we sell only in LMIC, which is roughly 135 countries, and where Shionogi does not either sell or has a stake in that country. So is the assumption that the 135 countries that we have, Shionogi does not sell in any of those? I know they can be small countries, but the assumption is they are not part of the 135 countries, right?
Yeah. Shionogi does not want to sell in those countries because the cost of Shionogi's product would not be affordable to those countries. That is the reason you can say on a humanitarian ground, they have out-licensed the molecule, because they don't have any commercial interest in those countries.
Okay, sir. Thank you. Those are all the questions that I have.
Thank you very much. We would like to remind participants that you may press star and one to ask a question. To ask a question, please press star and one now. The next question is from the line of Vishal Manchanda. Please go ahead, sir.
Thanks for the opportunity. Sir, on Zavicefta, just a clarification, whether you are partnered on this or it's entirely on your own?
Currently it's on our own, but we have talked about the intention to partner with somebody for the U.S. market because we do not have that expertise. So we are in discussion with various partners, and we should be concluding the deal pretty soon.
You have been litigated on this or yet to be litigated?
Litigation is yet to begin.
Okay. So is there a 45 day notice period after filing before which the innovator has to file a litigation? Has that concluded, that 45 day notice period?
To check with our U.S. attorney, actually, not updated on this subject.
Got it, sir. Just one final one, whether we are expecting any US FDA inspection for our sterile or oral facility in the near future?
No. I think these days they come for a surprise inspection. We don't have any notice from there.
So, you know, another way to answer the question would be they are due. They came last in July 2019, and they can come anytime as per their choice, so we are expecting them to come anytime.
Right.
Yeah.
So are we preparing, or it's like it is business as usual for you?
Yeah, it's business as usual. You know, Orchid undergoes an audit every week from one of its global customers, so that's not a problem.
Got it, sir. Thank you very much. Thank you.
Thank you, Vishal.
Thank you very much. To ask a question, please press star and one now. Participants who wish to ask question may please press star and one at this time. Ladies and gentlemen, I will now hand the conference over to the management for closing comments.
I'd like to thank all of you for your insightful questions. It's food for thought for us, and we always learn a lot from your questions. Once again, thank you for your continued interest in the company and for your support. Look forward to the same in future.
Thank you very much. On behalf of the Systematix Institutional Equities, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.