Ladies and gentlemen, good day, and welcome to the Q1 FY 2025 earnings conference call of Gufic Biosciences Limited. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star, then zero on your touch-tone phone. Please note that this conference is being recorded. Anyone who wishes to ask a question may press star and one on their touchtone telephone. To remove yourself from the question queue, you may press star and two. I now hand the conference over to Mrs. Ami Shah, Company Secretary. Thank you, and over to you, ma'am.
Thank you, Dan. A very good evening to all ladies and gentlemen, and a warm welcome to Gufic Biosciences Limited earnings conference call for the first quarter, and financial year 2024, 2025. Today, we have with us Mr. Pranav Choksi, CEO and Whole Time Director, Mr. Devkinandan Roongta, CFO, and Mr. Avik Das from Investor Relations team, to give the highlights of the business and financial performance of the company and to take questions, if any. Today, we have released our financial results and investor presentation, which are also posted on our website. We hope you all had the opportunity to go through it. Before we begin, I would like to say that some of the statement that will be made in today's discussion may be forward-looking in nature.
It is subject to unfortunate risks and uncertainties, and the actual results could materially differ. The company undertakes no responsibility to update or revise any forward-looking statement, whether as a result of new information or future events or otherwise. We will now begin the call with the opening remarks from Mr. Avik, followed by a financial overview from Mr. Roongta. Thereafter, we'll have the forum open for the interactive Q&A sessions. Over to you, Avik. Thank you.
Thank you, Ami, and thank you for joining us today for our conference call and pleased to welcome all the investors and our well-wishers. I'll just quickly give you all the highlights of all that's happened in Q1 within all our divisions. Starting with the Indore CapEx, this is one of the most transformative developments this quarter for Gufic, and this project represents a monumental step for us to scale up our operations and meeting the growing demand for our products. I'm pleased to report that we successfully completed the validations of two manufacturing lines at the Indore facility, and these validations are critical to ensure that our production processes adhere to the highest standards of quality and efficiency.
And looking ahead, the remaining validations are on track for completion by end of this month, with commercial production set to commence in September. This progression, following last quarter's trial run and immediate validation studies, ensures that our facility is well prepared to meet stringent regulatory and quality standards. And our Indore facility has also passed several key customer audits conducted by leading Indian and some global multinational corporates and our partners. And, this is, this further gives us confidence on the robust compliance and operational standards that we've set, and we hope to adhere as we scale up. And, as part of our, expansion strategy and, quickly going live with Indore, we've also commenced a product site transfer from our Navsari facility to Indore.
The confidence that some of our multinational customers have shown by initiating their own product site transfers to Indore also shows the strong capability that Gufic has and the possibilities of quickly ramping up Indore. So turning to our critical care division, we continue to fortify our leadership position in this space. This quarter, we've significantly advanced our antimicrobial stewardship initiatives by engaging with leading healthcare professionals in over 150 scientific activities across India in one quarter. So these sessions are vital in promoting the latest knowledge practices in combating antimicrobial resistance, which is one of the biggest silent pandemics, which is unfolding. We are also proud to announce the formation of a dedicated user group for dalbavancin, which, as you all know, is a unique life-saving antibiotic in treating complex infections.
This initiative will serve as a platform for clinicians to share their experiences and further the effective utilization of this very novel and crucial drug. In alignment with latest clinical guidelines, we are actively advocating for adoption of extended infusion protocols for mupirocin, a very widely used antibiotic in India, and driving better therapeutic outcomes. Additionally, we participated in Eurasia, where we showcased our comprehensive range of antimicrobials, reinforced our commitment to global healthcare advancements, and further solidified our presence in this space as a leading quality provider of niche antimicrobial drugs. The critical division has also seen continued growth in Q1 FY 2025, and we've built on our efforts to address the recurrent implantation failure.
We've initiated CME programs nationwide for Guficin Alpha. The drug's acceptability is backed by robust patient data, and its unique position as the only drug impacting all cytokine parameters involved in recurring implantation failure continues to drive its success. As of now, this is perhaps the only drug available in the Indian market that addresses all the cytokine parameters. So we remain focused on our development in ultra-purified HMG recombinant FSH, with advanced purification techniques and recombinant DNA technology. The ongoing trials and pending approvals highlight our dedication to providing best-in-class medicines in the ART space. We've also launched Dydroboon 20 mg and 30 mg sustained-release tablets, marking our entry into the extended-release formulation for Dydrogesterone. This innovative drug delivery system is expected to improve patient compliance and enhance treatment outcomes.
A new task force, Fertim ax, comprising of about 40 well-trained field personnel, has been launched to boost field efficiency and drive deeper market penetration, especially with our couple of very unique product offerings in this division. Coming to Aesthederm, the division continues to carve out a niche in the aesthetic dermatology market, particularly with flagship product, Stunox. This quarter, we initiated the first-ever clinical trial in India for botulinum toxin type A with our brand, Stunox, focused on labial frown lines and forehead lines. This is a groundbreaking study and aims to gather data specific to Indian patient pool. This will further help us enhance the confidence of practitioners and patients alike.
We've also launched a trial for Stunox in the treatment of hyperhidrosis, expanding its therapeutic scope and positioning Gufic as a versatile player in addressing a broader range of dermatological conditions. Our advanced aesthetic program at Arisia Training Center in Mumbai has also seen an expansion. We've now trained upwards of 80 doctors within a quarter, and this program is instrumental in enhancing competencies and driving market growth for aesthetic treatments. Now coming to Spark, Stellar in healthcare division, we've seen growth even in this division. We've expanded our CME initiatives, discussing the practical benefits of oral solid manufacturing, using the roller compaction technology, something that we use, and its impact on patient outcomes.
Additionally, we've also launched a digital prescription tool, which has helped streamline patient record management and significantly improved clinical efficiency for the doctors. So this becomes another point of partnership with Gufic in this space. We also made significant strides with a new product development, including the introduction of a cutting-edge potassium channel inhibitor in the proton pump inhibitor market. This is a huge market, as you know. It's almost a INR 3,000 crore market, and this is a very novel product there. And Gufoni for cervical spondylosis is another product that we've launched. Our targeted marketing strategies have led to improved market rankings for our well-established products like StretchNil, Sallaki, reinforcing our market presence in the osteoarthritis, especially through Sparsh. Now, coming to Sparsh.
Sparsh remains at the forefront of innovation with its direct-to-hospital distribution model. This quarter, we launched Teicoplanin in DCB dual-chamber bags and Daptomycin in dual-chamber bags and Esomeprazole, designed to meet the growing demand for advanced therapeutics in these hospitals and nursing homes. We are also very excited about the upcoming launch of contrast media in this division. Our strategic expansion into additional territories and planned growth of our team to 85 members will ensure that we have a very comprehensive market coverage and support for all our hospital partners. Sparsh division's ability to offer a wide range of injectables and secure significant volume share positions us as a leader in direct hospital engagement. Now on the international business front, the division we've received further new registrations.
We received registrations in Lithuania and Sri Lanka, further diversifying our global portfolio and giving us more entry into the European and Southeast Asian market. And as we speak, you know, we have almost 200+ registrations across 35 markets, and we have more than 4,150 products in the pipeline where we are targeting almost 40 countries. So with that, I think I'll hand over the call to to give a quick update on the financial performance in the quarter that went by. Thank you.
Thank you, Avik. I'm just going to highlight the Q1 financial highlight for Q1 of 2024-2025, compared to Q1 of 2023-2024 and Q4 of 2023-2024. The total revenue from the operation of Q1 of 2024-2025 is INR 202.8 crore, compared to Q1 of 2023-2024, it was INR 195 crore, and Q4 of 2023-2024 was INR 194.9 crore. The EBITDA for Q1 of 2024-2025 is INR 37 crore. Q1 of 2023-2024 was INR 36.4 crore, and Q4 of 2023-2024 was INR 35.17 crore. The EBITDA margin for Q1 of 2024-2025 is 18.2%. Q1 of 2023-2024 was 18.6%, and Q4 of 2023-2024 was 18%. The profit before tax for Q1 of 2024-2025 is INR 28.1 crore.
Q1 of 2023-2024 was INR 28.1 crores, and 2024, Q4 of 2023-2024 was INR 27.1 crores. The EBITDA margin for Q1 is 13.9%. Q1 of last year was 14.4%, and Q4 of last year was 13.9%. The profit after tax for Q1 of 2024-2025 is INR 20.9 crores. Q1 of 2023-2024 was INR 20.6 crore. Q4 of 2023-2024 was INR 20 crores. The EBITDA margin for Q1 2024-2025 is 10.3%. Q1 2023-2024 was 10.6%, and Q4 2023-2024 was 10.3%. The result are almost flat because the capacity of Indore in our factory has been fully utilized. Thank you.
Should we begin with the Q&A session?
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 Vishal from Systematix. Please go ahead.
Hi, thanks for the opportunity. Can you break up your sales between the various segments?
We have only one that we call it a, as per the SEBI guidelines, as company, we are only in one segment that is we call it a pharma company. But I can give, say that around 50%-55% is domestic sales, around 25%, between 25%-30% third party, remaining is export and after API sales.
So API should be around that 5%.
5%-10%, around 5%-10%.
Got it. Got it. And, I could hear in your opening comments about a launch of a product called Fertim ax. Can you share some color on that launch?
Yeah, sure. So hi, Vishal, Pranav here. So Fertim ax is basically a division. As you have seen, we already were in fertility, and we have more than HCG, HMG, FSH, but the focus there was already they had more than 42 different SKUs to focus on. Now, there are three new launches, that is Dydrogesterone 20-30, but more importantly, Guficin Alpha, which Avik explained, which is for a recurrent implantation failure. At the same time, there's a trial happening on this product with the DCGI for endometriosis. And number three, we have a super purified or ultra-purified HMG, where we have ensured that in for poor responders, when the, you know, the egg quality or is an issue, we have come up with a much more highly highly purified version, which requires a separate task force.
The Fertim ax is basically a task force to focus on these products. Of course, the task force was trained in the month of June, and, the launch happened in June, and that's why it's part of the last quarter. The actual sales impact came from July. So that was the basically launch of, Fertim ax, which is a division to handle these three brands or these, SKUs, which are for Dydrogesterone SR, Guficin, as well as, Ovigraf.
Got it, sir. So, these have been reallocated from a different division to this division, and you have not recruited new people. Is that the right way to look at it?
Not exactly. So I'll tell you, it's a hybrid model. So we already had around more than 108 people in the Ferticare division, where we took around 18-20 people from there, because there were some scientific-driven people who could go and who also wanted an aspiration to become, you know, leaders there. And anyway, there were some headquarters where the ROI or, you know, the PCPM was low, so we have shut down some, I would say, I would say, headquarters in Ferticare. Plus, we have recruited around 15-20 people from the market. So with a combination of 18-20 people from the Ferticare plus new recruits, that's how Fertim ax has gone.
Because we wanted the leadership, and the aspiration of the people also to be taken care of, and hence this hybrid approach was taken.
Mm-hmm. So would you be able to share what position Gufic would be in the infertility market? How large is this market currently, the infertility market?
I think the represented market where we have the existing product, because the Dydrogesterone itself is INR 900-1,000, maybe more than, more than that current market. And when I talk about HCG, HMG, FSH, progesterone and others, I think the total market size would be around INR 4,500, INR 4,000-INR 4,500. I can get back to you with exact numbers as per IQVIA. Coming out of that, we would be, I think, number four, I would believe, because there's a Merck, Intas, BSV, and then Gufic would be there in terms of the total scale. That's what knowledge is shared as per IQVIA.
... Got it. And like with BSV being acquired by Mankind, do you think there's going to be more aggressive competition in this space going forward?
It'll be interesting to see that, because in the past, if you see, JB Chemicals also had acquired, Sanzyme , and then JB add a different flavor to it. So it will be a very interesting thing to see how Mankind, who has been, till now in a different specialty, how do they handle the IVF product. Will be, I'm sure, Mankind being a wonderful company, they will definitely be aggressive, but it's a very different, ballgame as compared to the mass marketing in terms of prescription and cardiac, diabetes and all that. It's more different. So let's see. I'm, I'm as intrigued as you to see how they take it forward.
Right. And you would have quite a bit of overlap in the portfolio, like, what BSV offers and what you offer. There would be a significant overlap.
Absolutely.
Okay. And just one final one on the... I heard about another launch on a potassium channel inhibitor in the PPI market.
Yes.
I'm not sure if I heard that correctly.
Yes. You heard it correctly, potassium channel. So it's a different technology of, a molecule, which works on a different mechanism as compared to the proton-pump inhibitor, like we have pantoprazole, Omeprazole, Rabeprazole and others. It's a new launch. Again, the product was launched in the month of, I believe, the stocks came in June, and I think July, first week is when the billing happened. So this is opening another market. So if you see in ortho, as well as in gyne, the safety and the tolerability and long-term use of, antacids, let's put it that way, is, is important. So even in orthos, when we have anti-inflammatories and anti, I would say analgesics, there,
Right.
You know, there is a side effect of gastric irritation. And normally, PPIs are the main go-to drugs. Whereas we feel that the new launch, which is, I think, even got recently, U.S. FDA approval, and I think last year or I think in beginning of this year, they got U.S. FDA approval. And in India also it got DCGI approval in the month of March, April. And this will be something very interesting, which will definitely work on the landscape part of it. So let's see how it all goes there.
Okay. So this will be an alternative to PPI with promise of better efficacy or better tolerability, or both?
Tolerability, I would say, is better. Efficacy, of course, right now, the patient pool data, what we have in mostly Western countries, keeping the Indian DNA and the Indian diaspora, we will come to know. But yes, definitely as for published data, it's a better tolerability. The efficacy is comparable, because I think Pantoloc is quite a good gold standard, very frankly. But it's more about tolerability and long-term use. So there are, the mechanism is completely different than a proton pump inhibitor, by which the wear and tear is much lesser. That's what my medical experts tell me. But of course, time will tell me when we get more publications coming out also.
Like, there's an acute kidney injury risk that PPI have been labeled for. Does it have-
Yeah, like in extreme cases, you are right, with very high-term, long-term use karke. So yes, you are right. In that cases, this, this will have some advantage. But I'm saying I'm restricting myself because I'm not a medical expert, even though I'm educated by the medical team, but I would still wait, wait for more publications before I can comment, for sure.
You are among the early entrants in this category?
Yeah, that is what is going to be making... Like how we did it for Dydro, we would like to be one of the early entrants in this also.
Got it, sir.
Yeah.
Thank you. Thank you very much.
Bye.
Thank you. A reminder to all the participants that you may press star and one to ask a question. Participants who wish to ask a question, may press star and one. The next question is from the line of Bhavya Sonawala from Samaasa Capital. Please go ahead.
Yeah, hi, sir. Thank you for the opportunity. Am I audible?
Yes, sir.
Yes.
Yeah. So just two questions. First question is, again, with regard to the Indore CapEx. I just wanted to understand, does it usually take this much time in terms of media fills as well as validation batches? Or are we doing something different? Because I think last quarter, we had estimated some of the revenues to start coming from July, first week. So I'm just trying to understand, are we doing some other layer of, you know, audit or something different apart from how long it takes?
Sure. So I'll explain. If you see in Indore, we have total four lines.
Sure.
Line 1 and line 2 are lyophilized drugs. Line 3 is actually liquid vials, and line four is ampoule machine. So now, depending on so if you see from December, January, we have started marketing the products in terms of the capability to many companies, both in India and abroad also, especially keeping in mind the export market exposure. There, we also had one ex-U.S. FDA inspector come and auditor audit us also in terms of giving her relevant thoughts that we could make the modification before the actual media fill happens. So, depending on the product line, media fill has to cover a matrix. Since this is the first media fill of the factory, different vial sizes and different products have to be considered.
So for example, every product which we go for, there has to be three runs, which have to be in multiples and where there's a whole time study. So I will not bore you with the technical know-how, but as... So let's say today we are looking at in phase one, 58 different products to be started from Indore, where almost 26 products out of them will be sort of a tech transfer and capacity expansion coming from Navsari. So when I talk about a basic two ml vial of Fentanyl or maybe, you know, like, say, a vancomycin, which is almost, I mean, till now, the vancomycin which we did in Germany or U.K. or other markets, are mostly 500 mg and 1 and 1 g.
But we are right now talking to clients who would like to also source 5 g and 10 g vials. So I have to get a validation done of, you know, 2 ml, you know, 2 ml, 5 ml, 10 ml vials, 20 ml vials, 50 ml vials, and even 100 ml vials in the same setup... and that has to be replicated in three lines. Line 1, line 2 for lyophilization, and line 3 for liquid filling, where we are planning to do zero and we are planning to do even paracetamol. So out of these 58 molecules, whatever media fill needs to be done, we do it now. Now, let's say we don't do it now, we say we right now, we, for the next six months... So media fills have to be repeated every six months, just FYI.
And based on that, you have to do, when you first introduce a particular wild type, you have to introduce three different runs, and then you have to monitor that 28 days. I mean, that is including the 14 days of sterility also. Now, if we try to do something after six months, again, this entire 28-day cycle comes. So the dilemma which we have in front of us is that we don't-- we-- once the production starts, we cannot expect a closure or disclosure to happen, where we, you know, we'll have the pending orders. Already right now, in Navsari, we are facing serious issues in terms of backlogs, which we need to, you know, I would say, deal, I mean, just get them shifted to Indore very, very fast.
So the intention of the company was to take the inputs of the ex-U.S. FDA inspector, that we had audits done by three of our other international clients, combine them up, include all the 58 different products, and then we are going to get a complete validation done. Just to share with you what Avik said, line four was already finished, and we have started some runs, and this month they will, like I said, this month of September first week is when the production, I mean, the commercial production, where the device will be raised from line four and line three. Line one and line two, being lyophilized in the main heart of the machine, we have gone for a complete, like I said, from 2 ml to 10 ml batch size media fill validation, which normally on an annual basis takes around three to four months.
Even this is three to four months after finishing the I- you know, the other machine qualifications also. Because again, you have different diameter, different height, size, and different things like this. So yes, it was an option to do it now, or then after six months, take a break of around one to two months, which would not be advisable as per our internal calculation and our decision making. So that's why it's taking long, but hopefully, I think it is more, I think, frustrating for, you know, you and more for us here, because we want, we have backlog. You know, you can see orders in front of you, and you cannot cater to them. But at the same time, be very vigilant that, take the right time, because then you can't take a break after, you know, six months.
So let's hope in September we should start making around... At least our target is that we would should start making 25 lakh vials of lyophilized in September, starting with around 10 lakh vials of liquid. So that's our target from September.
Okay, that makes sense. Just a follow-up. You, in your presentation, it said that two manufacturing lines, kind of validation has been completed.
Yeah.
So are these-
Line 1, yeah.
So none of them are the lyophilized line 1. I think the one is the PFS, right? And then the other one will be-
No, no, no. One is the ampoule and one is the liquid vial.
Okay.
PFS is what we have already now, so we already are doing it. Line one and line two are the lyophilized, which are ongoing, which should be done by August and September first week. So that is where the commercial production will start concurrently. So right now, what we expect is line 3 and line 4 is done.
Okay. And, you had mentioned something about starting with 56, I think, units, right, initially. So can you just explain that? Are we shifting some from Navsari to, Indore and-
Different SKUs will be shifted from, I'm sorry, 58 different SKUs will be introduced into Indore, but out of that, 26, 27, I think I'll give you the exact number, will be shifted from. So I'll tell you an example: So, we are going to take 16 lakh vials of pantoprazole to start off with, to de-risk, to see how everything is going, and the next product will be Teicoplanin. So these are those 20-odd, 20+ odd products, which are already having capacity constraints in Navsari, which will be shifted here. Plus, addition of, 30-odd more products, which will be, you know, brand new entrants for Gufic as a whole in terms of manufacturing also. So that is how the plan is.
Oh, okay. Okay, understood. Just a last question. You spoke about... You told that in, I think, December, January, marketing, all the products that you're gonna, kind of manufacture in, Indore. So what kind of initial remarks have we got from our clients and, probably after their audits, some, if you can throw some light on that?
Yeah. So very frankly, what we did, we approached the problem in a different way. We went to IQVIA, IQVIA, earlier in October, November last year, then we spoke. And this is not only for India, but we went into certain 40-43 different countries, which we feel our focus are there with us. We found out these, list of, we shortlisted these of 58 products because of the market size and model the capability of the factory. Then we went and approached, different clients who are right now the leaders, or at least in the top five, top 10 of those, what do you call, IQVIA, for these 58 molecules. And after that, we filtered and came up with, partners who actually take care of at least two products, three products.
So you know, there's one client who is ready to trigger the U.S. FDA inspection with two molecules of them from Lyo. Then someone else is coming with us for a 100 ml liquid formulation. And, ampoule, again, I'm saying it's only focused for the European market where it goes as a diluent. Otherwise, line 1, line 2 , line 3 will be the main focus of U.S. because of the capacity. And that is what the efforts came in. And then DCAT was attended in March, and then finally, we have some contracts which we are getting into, because after media fill, their team will come for the final, what do you call, audit, and then we will start validation batches from October till March onwards.
So October to March, we have planned at least for the U.S. markets at least four different filings via our clients. Most of them are tech transfers now, because right now, as I clearly said, initially or even otherwise, we don't want to be an ANDA applicator on our own. We'll be looking to, you know, working with our clients and new partners to get these products in. And side by side, we already are targeting EU approval by the end of the year, where a lot of our capacity problems which are there for Germany, U.K., Portugal, and now very soon, even the other countries like Spain and France, will be then catered to from, I mean, from the same Indore setup.
So that is the plan, and results are positive, but it's only like I said, you know, it's more frustrating that once the ball starts rolling, the production starts, then automatically, you know, more people get attracted when the deliveries start coming out. So that's what we are targeting.
...Okay, that makes sense. I'll come back in the queue. Thank you so much.
Thank you. A reminder to all participants that you may press star and one to ask a question. Participants who wish to ask a question may press star and one. 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 Vishal Mehta from Welcardion. Please go ahead.
Hi, Pranav. Just had one question. Once the capacity from the Indore plant comes on stream, what will be the total revenue potential for Gufic as an entity? And, if you can just highlight how will we get there, and then what in terms of utilization, year one, year two, year three, that'll be great.
So if you see, Indore is around 1.5 times to what Navsari is. I'm not counting the PPI capacity and the Botulinum Toxin capacity. Just a like-to-like comparison of lyophilized, liquid vials and ampoules, it's 1.5 times. Of course, the ampoule and liquid, much more, but I'm looking at lyophilized as 1.5 times. The total peak, right now what we are struggling in Navsari, that's because of the contracts and because of then if we do a pantoprazole, we cannot do a ticagrelor or caspofungin. Where, you know, the top line of the pantoprazole would be around, you know, INR 30-INR 40 as vis-a-vis, our Caspo would be around INR 1,500 , Lyo ampoule would be around more than, you know, $40-$50.
So the issue is, the capacity with a peak of 700 at Navsari can go to a maximum, again, because of the product mix, to around 1,200-1,500, depending on the product mix from, Indore itself, with the existing capacity what we have installed, not counting the other, lines which are coming in the future. But this is what the thing. I, I foresee that 20, we hope that by, full running year will come in 2025, 2026, is where we expect that we should reach at least 30%-35%. Internal, our targets is 40%, but I think 30-35%. Then it would go to around, you know, 60% in the year after. And then hopefully, at the end of, I'm saying at 2027, 2028, we should have full capacity.
Okay.
2025, 2026, 2027. Yeah, 2027, 2028 would be almost close to full capacity.
So that will take our total sales potential to almost about INR 2,000 crores-INR 2,200 crores.
I would say INR 1,500 is what we tell everyone is what we are targeting the next three to four years, three, I mean, let's say around four years. So four to five years, maximum.
Okay. And this would be at a better margin, right? Like, we, when we get there, it will be a higher margin business or?
Yeah, it would be. If you already see in the last three quarters also, you know, because of the challenge we are facing our capacity, we are trying to do more profitable business and trying to, you know, get out a little bit, because anyway, capacities are against us for the time being. So definitely profitability would be part of it, especially where the export markets and the job works and the U.S. and Europe business would come into play. Domestically, again, the scale would help us. Also, as we mentioned, Sparsh is already started kicking in. So Sparsh also a little bit products. I would not say a little bit. I think a decent amount of products from Indore would help for Sparsh till we replace them with, you know, international markets.
So yeah, profit margin expansion is the way to go from Indore. At the same time, what we have done from Navsari, let's say, what was the total cost required to make a particular vial? In Indore, even after doing the INR 300 crore- plus CapEx, we have tried to get the running cost and the maintenance cost to be either same as Navsari or a little bit less. So that would be the target. So a lot of automations, a lot of technology equipments have been kept in by the, you know, entire factory. For example, I'll give you two, three examples, just to give you a nutshell.
So, the cost of water in Navsari will be little bit higher than Indore, because Indore has only WFI, but, it has what are the water for injection, which has, you know, better efficiency and running costs. The packing in Navsari, where we had hundred thousand vials were packed with, by 150 people, wherein Indore only, sixteen to seventeen people would be required to pack 100,000 vials. So again, all this would add up in the margin expansion, which answers your question. So it's not about efficiency, it's about scale, it's also about running costs, which helps us eventually to take care of it.
Great. So if I can just squeeze in one more question: what is our debt currently, and where do you think that will peak, and how do you see that panning out over the next couple of years?
I think, Roongta sir, I'll hand it over to him, but I think he is already there, but still he will give his comment.
Sure.
Yeah. Basically, we are having two types of loan. One is term loan. Term loan of INR 160 crore we have taken from the Indore property. Out of INR 160 crore, around INR 5 crore has been repaid, and around INR 15 crore term loan is outstanding for our Penem plant and Azaria plant. That is around INR 170 crore-INR 175 crore is a term loan. And we are having a sanction of around INR 150 crore of cash flow limit, out of which I can say around 80%-85% has been utilized. So total loan will be around INR 175 crore plus INR 120 crore, it will be around INR 295 crore, between INR 300 crore. INR 295 crore-INR 300 crore. This will be the peak loan. I don't think there will be further requirement of any additional loans.
In terms of deleveraging, how, how do we look at that over the next couple of years?
I think the next year, for one year, there will be challenges because the Indore is coming up, and for additional requirement of working capital for-
... stock, stock working capital requirement for stocks and the collection data, there will be need of additional working capital, which we are planning to be generated from the existing cash flow. So we've not decided to take additional borrowing from Indo- for our Indore plant. And from next year onwards, for 2025, 2026, I think the cash generation, we will be able to utilize around INR 75 crore-INR 80 crore to repayment the loan, and it will be repaid in the three to four years.
Great. Thank you so much for the answers, and all the best.
Thank you. The next question is from the line of Bhavya Sonawala from Samaasa Capital. Please go ahead. Mr. Bhavya, your line has been unmuted.
Am I audible?
Yes, sir, you are.
Yeah, thank you for the follow-up. Just, another two questions. Sorry for my ignorance, but when you say that there is a backlog in Navsari, so do these clients have enough stock for until Indore comes online, or how does it work?
So what we have done, very frankly, Bhavya, if you see in the March, you know, our debtors had taken a rise because of Sparsh and critical care, where the hospitals were a little bit of a concern for us, which we have little bit taken on a serious note on April to June. I mean, just using the example of capacity, and generally, we could not fulfill that. We have taken the option to take care of those, I would say, orders, which are a little bit more forthcoming and futuristic. You know, certain discipline in terms of debtors, where we already have seen improvement in these three months, and when we come up with the September numbers, you will see the changes in the debtors also.
That is something which we are using to maybe, you know, take care of, you know, I mean, postpone or not take care of certain orders in the domestic, critical care space, which would otherwise, you know, would have added INR 15 crores-INR 20 crores more on our top line. So that is where we are managing, because exports are something which are very watertight contracts we cannot get out of. Like, for example, I'll tell you, in the month of May and June, we had some PPI orders which we needed for Europe, which we cannot go through. Now, instead of that, if I did take care of strategic planning for U.K., I would have got a better top line.
So instead of INR 30-INR 40, we would have got a INR 300-INR 400 top line in the same capacity going forward. So such things for the time being, we are pushing a little bit to this quarter. Certain times our Sparsh and our critical care orders are little bit getting pushed ahead, because anyway, that financial discipline is being coming in terms of certain hospitals. So that is how we are managing. Of course, with Indore coming in, we hope that that will be relaxed little bit. Not at the cost of debtors, but yeah.
Okay. But then, is it possible that you kind of lose business because you are either pushing it or kind of you are choosing between, you know, between orders you have? So does that pose a risk in future?
Very frankly, you know, it's a very thin, red line, and that is why, you know, the CFO and our team is being very prudent and, you know, restricting and, you know, you know, I would say guiding our team properly, you know. Getting the business, the margins, vis-à-vis the debtors days are more crucial for us right now. Because we foresee enough scope in the international market, in spite of this also. So there has to be some place where we draw the line, that, you know, beyond 120, 150 days, if a hospital is not ready to pay, then it's difficult for us to sustain. So yes, we would be losing those businesses, and I would not... I'll definitely not deny that, but I think it's better in the long term.
There will be other opportunities which will come up, which will sail us through. So I don't foresee anything as of now.
Okay, understood. Just the last question. In the whole process of auditing the Indore facility, is validation the last step involved, or-
Yeah. Validation is the last step. Then you wait for 14 days for the results to come, and then you start commercial production.
Okay. And then, when we would like to kind of get more export market, more kind of countries get approval. So does that happen once the capacity is up and running, or is there some-
Yeah. So it, unfortunately, in pharma, the gestation time is little bit longer. So the moment the commercial productions will be happening, in like for U.S., if we take any batches, we have to store the batches till the actual inspection happens. In Europe, whenever you take a batch, let's say of 100 vials, I'm just giving an example, 30 vials which are required for validation will have to be kept for 40 vials, depending on the batch size. The remaining 60 vials you can liquidate in the Indian market or somewhere. For any country, when you have to enter, you have to have a, tech transfer done from Navsari here, or maybe a dossier made from Indore. Then the dossier is public. First of all, the plant has to be approved by that country, and then, you know...
So that's why our strategy to get an EU up, EU inspection done by the end of the year will help us, because once the EU approval is done, most of the countries open up in the world, except for U.S. and Japan. Now, with the EU approval in place, you know, at least the dossiers can start, we can start filing dossiers from, you know, November, December. I would not say November. I think if the production starts in August-September, then around December or January, with three months stability data, we start filing the dossier. So let's say 2025, we start filing dossier. The approval starts coming in from next year. The advantage of having an existing business in Navsari helps us to do the tech transfer much faster. So that is the thing which we are harping on.
Certain products which are already being made in Navsari, but capacity constraints are there, those, once the EU approval happens by the end of the year or early 2025, we can start seeing that business being amplified and transferred to Indore. Domestic will be the space for the first three to five months or six months. Then, tech transfer businesses start keeping kicking in from the next five to 12 months and so on. And then the new approvals and the new registration will start coming in after 1.5 to two years. Like U.S., we are looking at doing all the hard work in 2024, 2025, and hopefully for the 2026, mid or end commercialization.
Okay, okay, understood. And do we have an active ESOP plan right now? Because I think couple of quarters back, we had kind of,
... Yeah, I think it's already in place. I think I would like Ami to answer that, because I believe we already have announced for certain type of management, like the head of Indore and the head of certain marketing team. Ami, can you comment on this?
Yes, sir. So, in the last meeting held in the month of June, we have granted ESOP to six of our employees, and they have accepted it. So, we are waiting for the vesting period to get over, post which we would initiate the process.
Okay, understood. Thank you so much for answering all the questions, and I wish you luck. Thanks.
Thank you. The next question is from the line of Nikhil Chandak from JM Financial Family Office. Please go ahead.
Yeah, I just wanted one clarification on the answer you gave on the you know, so I think you mentioned INR 1,500 crore of top line. I'm just trying to understand the annual top line says roughly INR 800 crore at this point of time, and if the new capacity is 1.5 times the existing capacity with a higher margin, then shouldn't the numbers be much higher, or this is like a conservative estimate of INR 1,500 crore, you know, top line?
Yeah. So I'll tell you, Nikhil, so the issue is, you know, why we are giving the, you can say, conservative or pragmatic or, you know, worse come to worse numbers or whatever you say, is because, you know, all, like I was explaining the earlier question, depending on the country where we get the dossier, the permissions, what we get, the markets, what we get. The product mix is from a INR 30-INR 40 item to, you know, like a, let's say, a INR 3,000 item also. So the, depending on... There'll always be, you know, 40%-50% of our capacity, which will be taken by these volume products, which are, let's say, like a vancomycin or a pantoprazole or for that matter, you know, any one XYZ, I'm just naming two.
Then you have the high-end products like antifungals and then, you know, antibiotics, you know, which like a dalbavancin or a low, you know, amphotericin B liposomal, or even right now, we are trying to work in our liquid injections also for aripiprazole expansion or a depot injection with haloperidol. So the product mix is very crucial. And depending the orders and the countries, you know, of course, we try to aspire, and we said that the total recognized market is around INR 2,000 crores or INR 2,200 crores. There will always be on a pessimistic, let's say we get only vancomycin, pantoprazole, we miss out on that. So even though there'll be a margin expansion on happening on either, the margin expansion of a pantoprazole is lesser than as compared to a amphotericin B or a dalbavancin or aripiprazole also.
So that's why when we put our neck on the line, we try to give you the most, achievable thing, rather than, you know, saying what is not. Of course, our efforts will be to do much more because of the product mix and come up with new avenues. But we have invested in last year on a lot of R&D projects on those years and for things which are anyway getting us ready for the next three to five years.
Understood. So just to understand, for fiscal 2026, just ballparkish kind of a number, is INR 800 crore from the current operations and say roughly INR 700 crore from the Indore new facility. Is that the way you're looking at it?
No, no, no, sir. I think, like I said, you know, for us, I mentioned the capacity will be 25%-30%, or let's say 30%-35% on year one, that is 2025-2026. And there, 30% of that amount is what we are saying on a high, because there will be a capacity expansion happening from here also. So, I would say INR 1,500 in two years or 1.5 year, let's put it that way, what you expect might not be possible. So that's too ambitious because, you know, when we have an export market, the gestation period is very high.
Very clear.
So I would suggest from 2028 onwards, you know, I'm saying on 2027, 2028 onwards is where we should target it, where, which is much more. And then you will see the bigger number jumps coming after that because of the product mix going forward.
Understood. So roughly say INR 1,500 crore total company top line by 2027, 2028 is what you are expecting based on the, gradual ramp-up?
Yeah.
Okay. Okay.
Roongta sir, is that right? Would you like to comment something at, 2027?
2027, 2028, we can expect, or maximum there will be a delay around six months.
Yeah. Okay. Thanks.
Sure. Thank you so much.
Thank you.
Thank you. A reminder to all participants that you may press star and one to ask a question. A reminder to all participants that you may press star and one to ask a question. As there are no further questions, I would now like to hand the conference over to Ms. Ami Shah for closing comments.
Thank you very much. I appreciate all of you joining us today. If any of the questions remain unanswered, you can get back to our Investor Relations team, and we'll be happy to take those separately. With that, we'll conclude, we conclude today's call. Take care. Thank you.
Thank you. On behalf of Gufic Biosciences Limited, that concludes this conference. Thanks for joining us. You may now disconnect your lines.