Good evening and a warm welcome to everyone. Today in this call, we have with us Mr. Pranav Choksi, CEO and Director, Mr. Devkinandan Roonghta, CFO, and Mr. Avik Das from Investor Relations Team. So, and he will give the overview of the business and financial performance of the company and take questions if any. Before we begin, I would like to say that some of the statements 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 result could materially differ. The company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information or future events or otherwise. I hope you all must have received the investor presentations that we have posted on the stock exchange as well as our website.
We will now begin the call with the opening remarks from Mr. Avik, followed by a financial overview from Mr. Roonghta. Thereafter, we can have our forum open for the interactive Q&A sessions. Over to you, Avik.
Hello. Good evening and welcome to Gufic Biosciences' third-quarter conference call. We appreciate you joining us today as we share key updates on our performance, strategy, and vision for the future. As always, our focus remains on driving innovation, expanding our market presence, and enhancing the lives of patients through high-quality and scientifically driven pharmaceutical solutions, so I'll begin by discussing some of the key milestones from the quarter that are contributing to Gufic's continued evolution, so first, I'd like to start with our critical division, which remains a cornerstone of our business. Our division continues to solidify its position as a trusted partner for hospitals, offering a comprehensive portfolio of advanced injectables in the antibacterial and antifungal space.
As infection trends evolve and antimicrobial resistance becomes an increasingly urgent issue, we are addressing these challenges head-on with cost-effective and scientifically backed solutions that not only help reduce resistance but also optimize patient outcomes in the critical care setting. In the quarter that went by, we've taken several strategic steps that underscore our commitment to responsible antimicrobial use. We launched an awareness campaign focused on UTI management, which underscores the importance of rational antimicrobial prescribing. This initiative is critical, especially in India, where the burden of UTI is high, and antimicrobial stewardship is essential in curbing the rise of resistance. Additionally, we continue to strengthen our market presence through participation in leading medical forums, including Maha Criticon in Pune, ISCCM in Bangalore, where we engage with key clinicians and hospital networks.
These interactions allow us to stay at the forefront of infection management, share the latest insights, and ensure that Gufic's offering remains aligned with global best practices, including ICU and sepsis-related infections. Moving on to our Ferticare cluster, we continue to grow this cluster across the entire ART space. As the fertility landscape grows more complex in India, our focus on scientifically superior and process-driven solutions is helping IVF practitioners navigate increasingly challenging cases, particularly in treating poor responders and patients experiencing multiple IVF failures. These are areas where solutions have traditionally been scarce, but Gufic is providing targeted treatments like Guficin Alpha and Supergraf to directly address these challenges. One of the most exciting developments this quarter is the progress we've made in Guficin Alpha. It's a breakthrough treatment for recurrent implantation failure.
We believe this is a game changer in the fertility space as RIF continues to be one of the most persistent challenges in ART. Guficin Alpha leverages Thymosin Alpha, a hormone with over 2,000 published studies. It's a molecule accepted by U.S. FDA, has the DCGI approval, and it's been scientifically validated therapy, and it has been validated by independent practitioners, some of the leading chains in India. And we've come up with the conclusions which further back our findings that this enhances uterine receptivity and improves embryo implantation. Along with that, in parallel, Supergraf is India's first ultra-highly purified HMG. This is setting a new benchmark in IVF stimulation. This next-generation purification technology ensures better ovarian response, lower dose requirements, and improved success rates, especially in the poor responder category. This is further strengthening our leadership in this space.
These innovations, along with early clinical validation, have positioned us as a trusted partner for IVF centers and fertility specialists, especially the ones that are not seeing good results in the poor responder category. Now let's talk about Stellar and Spark division. Both divisions are driving growth in key therapeutic areas such as orthopedics, gastroenterology, women's wellness, and reproductive health. Stellar, in particular, is making strides with its Vonoprazan launch, which has gained strong uptake in the gastroenterology as a potassium PCAB, potassium competitive acid blocker, helping doctors manage acid-related disorders more effectively. Looking ahead, we are also excited about Guficox-P. It's a new combination therapy in orthopedics designed to address musculoskeletal pain with enhanced anti-inflammatory and analgesic effects.
Additionally, Stellar is expanding its reproductive health portfolio, including antioxidants to support both male and female fertility, making an important step in Gufic's effort to cater to the growing infertility management market. Meanwhile, the Spark division continues to leverage scientific engagement and product diversification to strengthen its presence in specialty segments while actively contributing to patient outreach and education through our initiatives in gynecology and ENT care. Next, I want to highlight our healthcare division, which remains committed to bridging the gap between traditional Ayurveda and modern pain management solutions. As more patients seek integrated therapies, Gufic is offering clinically validated Ayurveda-driven solutions that align with global trends in natural and holistic care. Gufispon , for example, has emerged as a preferred non-surgical solution for cervical spondylitis, an area where traditional treatments often fall short.
With increasing cases of musculoskeletal conditions driven by modern lifestyles, Gufispon offers a natural, effective alternative to non-invasive procedures. Additionally, Sallaki range, which continues to grow in popularity, has become a leader in the joint care market, positioning us as a key player in the natural anti-inflammatory therapies. We are also seeing tremendous engagement through initiatives like bone mineral density screenings, which we have done. This fosters early diagnosis and preventive care for conditions like osteoporosis and arthritis. Lastly, I'll talk about Sparsh division, which has made significant strides in expanding its product portfolio and reinforcing its direct-to-hospital model. This quarter, Sparsh expanded its offering with select contrast media. As we all know, contrast media is a specialized product for diagnostic imaging, and few companies in India are providing this product.
This additionally significantly enhances Sparsh's competitive position and expands its footprint into critical care and the fast-growing diagnostic imaging market. By directly addressing the needs of mid-size and smaller hospitals, Sparsh continues to deepen its relationship with healthcare providers, positioning itself as a key partner in even diagnostic solutions. This strategic expansion allows Sparsh to capture a larger share of hospital budgets, further reinforcing our strategy in the direct-to-hospital model. Finally, our international division continues to strengthen its position with key product approvals across global markets. The most recent approvals in regions like Sri Lanka, Lithuania, Ecuador, and Kenya reinforce our commitment to expanding our global footprint. These approvals are essential for opening doors to new markets and increasing Gufic's presence as a leading supplier of high-quality pharmaceutical products worldwide.
As we continue to grow our presence in regulated markets, these strategic registrations pave the way for future opportunities, especially coming out of our new plant at Indore, which has now commenced production. Thank you all for your continued trust and support in us. I'll now hand over the call to Mr. Roonghta for detailed discussion of our financial performance, after which we'll be happy to take your questions.
Thank you, Avik.
Thank you, Avik. I'll just highlight the financial results of Q3 of financial year 2025 also.
Sorry to interrupt there. So we are sounding a bit distant.
I'm just highlighting the financial results of Q3 of financial year 2025 versus Q3 of financial year 2024. The total revenue for the operation for the financial year 2024-2025, Q3 is INR 207.8 crores compared to Q3 of financial year 2023-2024, INR 21.8 crores. The EBITDA for the current year financial Q3 is INR 35.8 crores compared to the previous Q3 of financial year 2024, INR 36.9 crores. The EBITDA margin for the current Q3 is 17.23% compared to Q3 of last year, 18.29%. The profit before tax for Q3 of financial year 2025 is INR 26.3 crores compared to Q3 of financial year 2024, INR 29.6 crores. The PBT margin for the Q3 of financial year 2025 is 12.66% compared to Q3 of financial year 2024, 14.67%. The profit before tax for the Q3 financial year is INR 19.4 crores compared to Q3 of financial year INR 22.3 crores.
The tax margin for Q3 of financial year is 9.34% compared to Q3 of financial year 2024, 11.05%. Now I'm highlighting the financial results for nine months of financial year 2025 versus financial year 2024. The total revenue for the nine months of current financial year is INR 614.8 crores compared to INR 616.7 crores last year nine months. The EBITDA for current financial year nine months is INR 111.6 crores compared to previous year nine months, INR 112.9 crores. The EBITDA margin for current nine months is 18.15% compared to last year nine months, 18.31%. The profit before tax for this current year nine months is INR 83.6 crores compared to nine months of last year was INR 88.6 crores. The tax margin for current nine months is 13.6% compared to nine months of last year 14.37%.
The profit before tax for nine months of current financial year is 61.9% compared to nine months of last year 66.1%. The tax margin for current nine months is 10.07% compared to 10.72% of last nine months of financial year. Thank you.
We can now start with the question-and-answer round.
Sure. 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 phone. 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. Again, if you wish to register for a question, please press star and one on your touch-tone phone now. Participants, you may press star and one to ask a question. Nayan Taparia, investor, please go ahead.
Hello.
Yes, please go ahead.
Hello.
Yes. Nayan, sorry, your line is unmuted. Please proceed with your question.
Yes. Congratulations for the stable set of numbers for the Q3. I would just like to know what is the top line we will do from the Indore facility? The revenue is still not seen from that facility. Because it is a new facility, what is the top line we will have from there?
So, Nayan, we are Pranav. Yeah, how are you? Thank you for your call. So I'll answer your question. Firstly, sir, the numbers are not something which we would have predicted. So even in spite of the congratulations, we are still working hard to change that. I'll give you a little bit of a logic also behind that, why the numbers are. But let me answer your question for Indore. As we have mentioned also in the earlier presentation and also in the announcement, the production of Indore has started from October 2024. And the first revenues were captured to the tune of INR 6 crores in this quarter. And the total potential of Indore, of course, is much higher. But you can just imagine that Navsari right now helps us to contribute to this INR 800 crores.
With Indore coming in, Indore has almost 1.5 times capacity plus two, three new product lines also of ampules and specialty formulations. The potential of Indore can be considered 1.5 times Navsari with all these things. That is the highest potential. Of course, it will be a gradual increase which will happen once the regulations start coming in. The validation data has been completed, like I mentioned in October. Then the first set of products started being manufactured. Now more and more validation will get complete and more and more orders and more and more clients will approve us. Followed by, there will be WHO GMP, which has just been finished, and we have achieved that in the month of January. Now we are going to go for EU down the line along with other countries' approvals also.
We will foresee growth happening of around 25%-30% capacity utilization in the next year, and then followed by 50%-60% the year after that.
Oh, nice. Okay, sir. One more is you had attended the CPHI?
Yes.
Which one, sir? The one in Delhi
and Saudi Arabia?
Yes, yes, yes.
Yeah? So how was your experience there? How are you able to?
So CPHI is always good. As long as it gets translated into business, it's good. But yes, right now we will be attending a lot of exhibitions and conferences. We also attend a lot. Our team is also going to DCAT next year, next month, sorry, in March also for the U.S. business. So we keep on attending. The response has been good. But till it translates into numbers, business top line, bottom line, we are working very hard for that.
Okay. One more there. Regarding debt, are we going to take more debt, or is it now for timing? This will be the?
No, this is a peak debt, sir. I think Roonghta sir will answer this question actually better than me. So I'll hand it over to him. But according to me, it's a peak debt. And till Indore starts generating and we become cash positive, we will not. But Roonghta sir, can you answer this, please?
Yeah, yeah, definitely, sir. Yes, sir. We are having two types of loans. One is term loan. Term loan is we have taken for Indore as well as certain loan from Navsari. The term loan today outstanding is around INR 165 crores. And working capital loan overdraft limit is INR 200 crores. But utilization is around 80%. So today outstanding is around loan outstanding is around between INR 300 crores. And I don't think there will be any possibility of further increasing in the loan. I think this is a peak loan. And over a period of time, after the cash generation from Indore, the loan will come down.
Okay. That's it from my side, sir. Congratulations for yours.
Thank you. Next question comes from the line of Yogansh Jeswani from Mittal Analytics. Please go ahead.
Hi, sir. Thanks for the opportunity. Am I audible .
Yes, sir. But there is an echo from your line. So if you're using speakerphone, may we request to use handset, please?
Sure. Is it better now?
Much better, sir. Please go ahead.
Yeah. So, Pranav sir, hi. Thanks for the opportunity. Sir, in your opening remarks, you mentioned about several new products that we have launched in Ferticare and similarly on other segments. So if you could just broadly help us understand what are the potential and at what stage are they in terms of their market launch and what is the kind of response we are getting? And how much of a revenue can they add to, say, in quarter four or FY 2026?
So there are two things. So the first thing is in Ferticare specifically, and since your question is for Ferticare, we have launched Guficin Alpha, which is for recurrent implantation failure. Right now, the product is already launched since May 2024. We have started with a patient pool of around, I think, 80 patients in the first month. And now we have reached a total patient pool of per month of around close to, I think, 300 or 330, I think, patients per month. So this is something which is more of concept selling where there is hardly any other solution available. So we're working with the, I would say, the FDA and the CTRIs also to do a phase IV side-by-side because it's already an approved product. We're trying to get it approved for a new indication. And that is where we are doing some trials.
So once the trials are also done parallelly, we will see more and more of it because it becomes part of the protocol going forward. So recurrent implantation failure are normally between 20% of the IVF cases right now. So it's quite a big market. There are some conventional other products used, but focusing on immunology as one of the options where there are inflammatory parameters by which certain times the implantation is affected is something new. And that's why more scientific data is being done. So this is the case and the current status of that.
Our next product is Supergraf, which is, I think, doesn't require so much scientific, but we are, of course, doing more of sampling and product that is getting a much faster response because it's a more highly, I would say, a super purified version of HMG, which is anyway a conventional option used by doctors in the field of infertility. This product is taking higher fraction. I mean, it's taking momentum much faster because it's a well-established concept, and it's a much more superior product. So this product is actually increasing by almost 8%-10% month -over -month. So we hope that this would be one of our main anchor products, not only in Q4, but from the year to come also. So the total market size of HMG in India is around INR 484 crores. This is, of course, as per December AWACS, what I'm referring to.
Out of that, this is MAT numbers. Out of that, we have a Puregraf, which is already around INR 25crores -26 crores. We feel if Supergraf handled efficiently and done properly, Supergraf can be close to a INR 10-crore brand in the next year. So that is how we are looking at in step one. But down the line, seeing the INR 484 crore market potential, we hope that we can start to go to at least 10%-15% of the market share in the next two to three years. So we will see a small use happening and then it actually going from 10% to 25% and 25% and beyond. Because we right now have only around 22 people promoting this. Down the line, we have plans to gradually bring it to the other divisions also.
Once we know that enough data and enough endorsement of doctors is there, and then we take it to a higher audience. So that is the second product. And of course, there are others, but let me focus on these two right now, which is going to be the main focus products of Fertility Care.
Got it. And similarly for other divisions, you were. I'm sorry, I couldn't take a couple of names because I missed out on the exact names. But I think in critical care and then in Stellar also, you were mentioning a few of the launches. So this commentary was quite helpful, how you explained for Puregraf and Supergraf. Similarly, if you could explain as for Stellar and critical care.
So critical care is the issue what we have faced not only in critical care but also for STG this year, right? There are around seven molecules of Gufic, which are not only in part of our domestic marketing, but even for export and even for contract manufacturing. They have faced sort of a price erosion. So why I'm giving you this factor to answer your question is because there are products like ceftazidime avibactam, which was launched, and there has been a price erosion. And then there has been now this combination of what do you call aztreonam avibactam we are working on. So that is still yet to start the clinical trial. So these all products are adding value in the last three, four months.
But then we have a conventional set of seven molecules who are 20%, 20%, 25% of our revenue generators of last year, where the pricing is almost down by 60%-80%. So when I give you these new numbers in perspective, always just keep that in mind. Also, there are certain products where the API price has gone down, other things have gone down. So that is why also we have seen the thing. So in critical care, to answer the question specifically, we have now aztreonam avibactam, which is planned. Before that, dalbavancin was launched. Dalbavancin, we again follow a patient pool mechanism where we hope that it becomes close to an INR 8 crore-INR 10 crore brand. Aztreonam Avibactam is something which we have just started the DCA process. So that will be the revenues will be captured in the next six months.
However, ceftazidime avibactam, where we have known for and has been seeing that as even though there has been a price erosion by almost 80% of the price what we used last year, but the quantities have increased by almost 30%. So even though we are a little bit net down, the growth is still there. So like that, there are two. I'm just giving you two molecules example of each division. In botulinum toxin, the different thing in the aesthetic division, that is having no price impact or nothing. So that is actually growing again. Like I said, the base is small, but the growth has been almost another 60%-65% year -over -year. But the base being hardly in those, I think, INR 10-15 crores in aesthetics and are remaining around INR 8core -INR 10 crores in the neuro space.
The base hardly increase of around INR 10 crores increase is not showing overall in the entire company's revenue. But that botulinum toxin, followed by pillars to be launched in the next three to six months, will be the growth, I would say, factors in Aesthaderm. And then we have Sparsh. But then I can keep on going on because I have too many divisions. But I'll focus on the top three divisions, that is Ferticare , Critical Care, and Aesthaderm, where I have given you answers. If anything more is there, please write to us. We'll give you a special division-wise feedback for all the remaining four divisions also.
Sure, sir. It will be really helpful. I'll reach out to the team. I'll write to Avik ji and seek these details. Secondly, on the Indore side, in terms of the expense, are we left with any more expenses or the expenses are already done and just once these trial batches are accepted and the approvals come in, we can scale up?
Yeah. So scaling up will always in pharma and injectables especially take time because one is, of course, our domestic business, which we will start immediately. So already you've seen INR 5 crores-INR 6 crores revenue captured of our domestic business in the first quarter and so in the last quarter, that is Q4, you will see more business where we are more products coming in. Some, I would say, companies have started giving us the authorization to start their CMO business, which we see around Q1 next year. And then by the end of Q1, we will have the EU GMP coming in also because certain validation we will submit. So you will start seeing a little bit of export also by Q3. So you will see that revenue transitioning from baseline to Q4 2025, which will be Gufic oriented.
Then from next year, it will be a mixture of CMO opportunities along with export starting kicking in. So that's why the graduation and gradually happening. Answering your question, expenses are all done now. Like Roonghta sir also said, we have not only the OPEX operating expense, which are happening every month, which will be there, which will be there correctly. But in terms of CAPEX, I think everything is done.
Okay, okay. And so last one question, and then I'll get back in the queue. So if you look at the longer-term trajectory of our operating margins, that has been something around 17%-19%. While in past, our endeavor or guidance has always been that the model we are working on, that we want to bring out products which are different, maybe in terms of how they are delivered to the patients or maybe something or the other we are trying to do. And the intent is to increase our margins. So now with so many of the launches already out there in the market and then few more coming up, when do you see the benefits of increasing margins reflecting into numbers? Do you see FY 2026 to be the year?
Again, I will talk to you what I have limited knowledge about. And then, of course, I'll ask Roonghta sir to come in. But before he comes in, I would like to tell you two things from my side. If you see the gross margins in the last few quarters have anyway improved because of the product mix which is happening and also because of the increase of UK business and export business. And anyway, there were capacity constraints still last quarter. That is, I'm saying, Q3 2024. We always had to take a choice between what we do. And sometimes it's not that we could only do the high margin stuff because we had an obligation to fulfill the domestic contracts also. Now, that is about the gross margins.
In terms of the other margins, in terms of employee and also in terms of the other expenses, you will see a peak coming for the next two, three quarters maximum because that is where Indore will still have to gather. Revenue of Indore will be catching up to the expense of Indore, which will be anyway full-fledged captured also. So those margins for the next two to three quarters will be seen on the lower side because of these employee expenses and the other expenses and the depreciations and the interest costs. And then once the Indore revenue starts coming in, which we are expecting, then you will see that line of baseline increasing against the other, I would say, the EBITDA margins also. Till then, the gross margin should definitely improve. That is what I wanted to make a point correctly.
However, I think Roonghta sir, you want to add something to what I have missed or something more?
Yes.
Basically, if you see our gross margin, that is basically sale minus raw material and starting material, that has improved by around 2% from last two years' basis. But because of the increase in the employee cost as well as other expenses, the EBITDA margin has been come down by 1%. Because of the increase in the depreciation and other expenses, in the near future, after Indore startup, we feel that there will be a pressure on the EBITDA margin as well as PAT margin. But after 2026, when the capacity utilization of Indore will be picked up, I feel that the EBITDA margin and PAT margin is going to improve after 2026 onwards.
Got it, sir.
Thank you. Next question comes from the line of Rahul Girish Shah from Glowstar LLP. Please go ahead.
Yeah, Rahul Shah from Glowstar LLP. My question is to Mr. Pranav. Can you give overall Indian formulation industry overview and its future ahead? And Gufic's competitive advantage among it and market share, just elaborate the whole formulation industry for me.
Rahulji, if I understood your question right, you want me to talk about the Indian or the global pharmaceutical industry and their perspective vis-à-vis Gufic. Is that right?
Yeah, lyophilization. Lyophilization in particular, how the Indian lyophilization industry is placed and how is Gufic? What are the Gufic's competitive advantage in?
Okay. And only specific to the lyophilization, right?
Our edge over the competition?
Yeah. So again, I think if you have been following my discussion, because it's a very broad-ended question, but I'll still try to complete it in the next two to three minutes. So if you see the lyophilization is just a, I mean, 10 years, 15 years ago, it was something which was worthwhile. Now it's become a commodity. So the capacity is something where you can say Gufic is having one of the biggest or the largest capacities now, not only in India but in the major parts of the world. If you compare it as a single unit, we have a huge capacity. And that is where the advantage comes off. But the advantage of capacity is a small part of the entire, I would say, offerings of Gufic.
The product pipeline, the capability of handling complex injectables, and also the wide range of flexibility of having different dosage forms. The application of lyophilization of Gufic into botulinum toxin and now future biological is something where Gufic's offering is a little bit different than just being a lyophilized CMO or a lyophilized manufacturer. That is where I would differentiate, or I would say this, I would classify or perceive Gufic from an outside view. The Indian lyophilization market overall must be growing in terms of volumes a little bit higher in double digits. Value-wise, it might be single or higher digits because that is again because of the product pipeline. Like I said, it is a very often thing because lyophilization has multiple applications in oncology and in food industry and others.
Whereas we are focusing mostly as Gufic only in the general antibiotic and intensive care and ICU-based products along with parenteral nutrition, infertility, and like I mentioned, aesthetics, neurology, and others. So our product segment and the product focus is also very sharp, and we are not into everything what lyophilization is into. But in whatever we are, we are trying to be a dominant player in terms of the pipeline, the capacity, as well as the efficiency in terms of the differentiation products and new drug delivery systems. That's how I would like to classify it. I don't know if I answered your question. I tried my level best to do it in two minutes.
Perfect. Yeah. Yeah. I got an idea. Thanks. Thanks. Thanks very much.
No problem.
Okay. Thank you.
Thank you. Next question comes from the line` of Shirish from PKD Advisors. Please go ahead.
Hello. Am I audible?
Yes, sir. Please go ahead.
Yeah. Hi. My question is for Pranav. Pranav, could you kind of elaborate more on the Botulinum toxin revenue, which you're probably seeing by FY 2026, and what are your strategies to grow that?
Sure. So like I said, I already gave a little bit of hint in the two questions before in terms of the numbers. I'm looking at the growth of 65%. A little bit changes we have done recently. I don't know if you have been keeping a note on us that we just have got Mr. Vijay Kumar to join us. Right now, this aesthetics was actually part of a strategic business unit under a common unit of women healthcare and aesthetics. We just have got two senior members. One senior member from BSV, that is Mr. Rajiv Agarwal, who will be handling infertility as a separate cluster. And then we have got Mr. Vijay Kumar, who had spent more than six to eight years in Galderma before that, also in there. He's in other companies where they are focused on aesthetics purely.
So he has joined me, and he has joined us. And along with that, we have a separate team member who's handling what do you call the neuro care side of it or the therapeutic application of Botulinum toxin, who has been working in Merz and before that, other neurological companies. So there's a clear-cut demarcation we have done this year from January onwards because we feel the base has come, and now it's time for us to go to the next level in terms of getting our activity. Because UCPMP guidelines have always been there.
We are looking at more and more scientific base and more and more engagement whereas promoted by the UCPMP and go for more scientific discussion and create more clinical data in different, I would say, therapeutic indications in the aesthetic space as well as the neuro space and also focus more and more on training. With Mr. Vijay Kumar coming in, we also have we get a clear-cut, I would say, legacy lead into doctor engagement because there also what the doctor expects in terms of the cadaver training, what are the multinational guidelines in terms of creating SOPs, also creating protocols. That just makes it much more easier.
And also a lot of doctors who used to consider Gufic as a new player would also now endorse us much faster because then we have a big brand, SMNC Khalid, who's endorsing our brand and bringing them as an offering also. So this is our plans into it. And this is how I again feel that with these factors and these, like I said, clinical data, scientific input, and also trials, and also more and more trainings, which have always been our main forte. We invest more than what we earn only in training and development because we feel someone has to get this category expanded. You can't just keep on. It's not a category where you have to take a market share. We're already number two. We are after Allergan.
But we have to not only increase the market share, but at the same time, we have to increase the overall market size also via category conversion. That is always, I mean, category expansion by doing more and more doctors converted to, and equip them with the skills to do these aesthetic as well as neurological techniques, so this will be the way forward qualitatively, and hopefully, that will help us in the quantitative numbers, which we have envisioned where we hope that this year we did only 65%, but we were hoping to double. We could not do that, even though we have done the huge amount of investment in the category building, but I'm sure that appetite will still continue for us.
Understood. I have a follow-up question, Pranav. So pardon me if I've missed something in the past, but do you plan to expand this internationally, trying to capture the East Asia markets or the U.S.?
We do. But very frankly, right now, our entire bandwidth is very focused on two, three things which are very important, the Indian space. So once we get into the international space, we had options. Very frankly, there were opportunities also, which we had to. But at that time, we very frankly put it on hold because a lot of things, our bandwidth would have been used now to create a new infrastructure to then take the product to the international market. So we purposely have stayed away from it. Our next focus is to first get Indore running, get the domestic business a little bit more aggressive along with the help of Indore capacity. Then Botulinum toxin, let's focus on the next one year, at least on the domestic market, bring it to some more because the GCs are very high.
And we really feel India is a market which really has to take a lot of bandwidth and work. And then maybe after one year, we will definitely look at thinking of the international market where a new infrastructure will either have to be created or we might need to outsource it from an existing CMO or something. So we can always discuss this after one year when we have a little bit less things on our mind and a lot of things have picked up by then.
Understood, Pranav. Congratulations on the good quarter, management. Thank you.
Yeah.
Thank you. The next question comes from the line of Vidit Shah from Spark Capital. Please go ahead.
Hi. Thanks for taking my question. My first question was on the new product launches. We've had quite a few of them over the last six to eight quarters. If you could just help me understand what are the blockbuster ones now that we've seen some sort of feedback come through, what are the products that you believe can be INR 50 crores-INR 100 crores of revenue from the new launches over the medium to long term for Gufic itself?
Yeah. So right now, I'll focus on the domestic space purely, where internationally, it's a different ball game. So in domestic space, the ceftazidime avibactam, followed by dalbavancin, are the two products in critical care which I just mentioned some time ago, which have that blockbuster space. Dalbavancin has reached only because it's the first time we have launched in India. The MNC or the innovator is not here. So we have still reached a basic scale of only around INR 3crores-4 crores in a year. But we hope that with more and more resistance and other issues coming in with teicoplanin and vancomycin and linezolid, vancomycin will have its own positioning. So we feel vancomycin sorry, dalbavancin, sorry, I was talking about dalbavancin.
Dalbavancin has a potential of going from INR 3 crore to at least INR 15crores-INR 20 crores, and then eventually more once the positioning and the market acceptance comes up. We also have reduced slashed the prices of dalbavancin by almost one-third now because of the efficiency of the API and all that to make more and more doctors start using it. This has a potential value of a high, at least a INR 40 crores-INR 50 crores down the line if I talk about. Secondly, of course, Ceftazidime Avibactam, which is already, I think, a INR 20-crore molecule for us in the last two years of launch. January 2023, I think it was launched. This is going to grow more.
Of course, this might a little bit be affected by our next launch of aztreonam avibactam, which is right now in DCGI because that is another having a blockbuster potential where the entire market size can be around 250 crores. Whoever launches it first right now, Pfizer has just got the approval in August 2024, and we are the first Indian company to apply to DCGI for it. So let's hope how that works out, and once we get the approval, hopefully, by next year, we can get some feedback. Coming to fertility, I already mentioned about Guficin Alpha where it'll be a little bit of a slow, painful journey because it's more of science and getting trials done to get the product big. It has the potential to become in that number which you mentioned, and Puregraf. Puregraf, like I already mentioned, it's a 484-crore market.
Our other HMG is already around 2025, and this potential has itself to bring it to that level. Starting with, at least on the first year of launch, it should be INR 10 crores and then followed by much more. And then, of course, we have botulinum toxin where botulinum toxin, both in neuro care and aesthetic space, can be that big enough molecule. So like I said, I will only focus on these three divisions right now and tell you more insights about them. Other divisions, we are more than happy to write back. You can write to us, and we will give you more about them.
Okay. Understood, Lord. This is helpful and very detailed, so thank you. The other question I had was on the Indore facility. If you could just help explain if we are tracking the amount of cash burn that is happening currently and when do we expect this to be breaking even?
Okay. I think this is a cue for Roonghta as well to step in so Roonghta, you will take this question.
Basically, just now we started the production, and for Q4, we are expecting that the revenue can come around INR 20 crores. From 2025, 2026 onwards, we feel that the revenue should be minimum INR 150 crores by additional revenue from the Indore plant. That is our expectation, and depending upon the validation batch, approvals, as well as audit by the third parties. But we expect that revenue from Indore should be INR 150 crores in the next five to three years.
Okay. Sorry, Roonghta.
Yeah, I'll ask you a question. I think Roonghta did not answer. Roonghta, they are asking how long would the cash burn last and when would we be breaking even?
Breaking even. I think the breaking even will be going to take around four to five quarters. It will be the fourth quarter of 2025, 2026. I think the break even will be good to come.
Got it. Just.
Indore and isolation. Yeah. Indore and isolation, just to clarify it. Yeah.
If I could squeeze in a clarification, in one of the opening remarks, I think you said that you expect the utilization to go up to about 30%-40% in FY 2026. So that would translate to a revenue much higher than INR 150 crores, like what Roonghta has said, right?
Yeah. So I'll tell you, there are two types of businesses. One is, of course, a CMO business, which only conversion cost is captured. And one is, of course, the third-party business where, of course, the actual revenue is captured. So initially, before a registration comes in, only the domestic business will be capturing the revenue on a TP basis. Whereas in the first year, we expect a lot of loan licensing work done for MNCs and big companies till our export registrations kick in. So those revenues, even though they have a projected revenue of much higher because this is purely on the conversion cost space. So there'll be a 50%, which will be transfer pricing, and 50% of the revenue, 60% of the revenue will be still CCPC. And that's why that revenue will be a little bit lower. But it's more purely CCPC, not RMPM involved.
Got it. And just the last one. So I guess we ramp up Indore by FY 2028 to full utilization. Any other CAPEX that we have in mind that we're looking at or contemplating, given that that will also take a couple of years to come up? So what is the management thinking about the next steps of CAPEX?
So 2028 will be great if it's done. I think 2028 or 2029 because, like I said, we are very selective and very, I would say, we are very careful what we get into Indore because it has a U.S. FDA appetite. So just to fill capacity, we might not be just getting anything just for capacity utilization. So 2028 to 20 29, I think time will tell. But our efforts are on to get it done as soon as possible, just to clarify that. Coming to the next point, yes. Right now, as of now, if you see, as a company, most of our efforts, which have been in the past, also in the R&D scale. So we are evaluating post-Indore, maybe something to be done on the Botulinum toxin or the Botulinum toxin space.
Otherwise, most of our work will happen in R&D, where we are looking also at strategic tie-ups where instead of investing in our own, I would say, capacities, maybe at least utilize somewhere as a CMO and then use that money for filing and regulatory purposes, which are a little bit much more. Because we talk about Botulinum toxin, and then we talk about infertility, and then we talk about the oral vaccines in the future. All of them would be much better off that instead of putting money in our own capacity, we can always have, I would say, outside CMOs available, which can help us to take it to the next level. So that is the approach right now. Maybe in one year, we will be more clear, and we'll share with you more information.
Okay. Understood. And thanks for the clarifications. Understood.
Thank you. The next question comes from Chintan Shah from GM Financial Family Office. Please go ahead.
Hi. Thank you so much for the opportunity. Roonghta, I have two questions. So one is, if I look at the Indore facility, we are planning to go to regulated markets here. And please correct me if I'm wrong, but this is the first time we'll be doing another audit for this regulated market. So my question is, if the Indore facility ramps up, say, beyond FY 2027, beyond the 13%, 14%, 45% utilization, depending on this regulated market picking up, or do we think that even if that gets delayed or there's some issue and it doesn't happen, we have enough bandwidth to ramp this up without the approval from the regulated market? That is my first question.
Yeah. So very frankly, when I mentioned those capacities, I'm only using for next year, mostly Indian domestic business, both CMO as well as own brands, as well as a little bit of export in semi-regulated to maybe a little bit of a European business also starting by Q4. So we are expecting an EU GMP, hopefully, in Q2 or max Q3 2026. So U.S. has not been factored in my capacity utilization for next year. Also, U.S.'s main focus is purely as a CMO because we also want to learn and evolve in the process. We don't want to take any shortcuts because a lot of people are guiding us. We already had four audits by four different agencies and two different companies. Also, six audits have happened for the U.S. market specifically, and they all have been guiding us and hand-holding us.
So I would, again, refrain from putting any numbers or capacities of U.S. as of now in the next one or one and a half years. It would all start coming in after that, which would, of course, be a different volume. That's too, I would say, preliminary for me to comment on U.S. right now for the facility. There are others, so answering your question, 30% or 30%-40% would be something which we wish to take care of the domestic and the semi-regulated and the European and other markets except U.S. and Japan as of now.
That is fair enough. Just one clarification here. I mean, just excluding the supposing it doesn't happen, do you think there's enough potential sales in the domestic or semi-regulated markets for this Indore facility to ramp up, or we would be dependent on regulation?
Yeah. So even right now, if you see the order books are in such a way that I'm struggling in Navsari right now. We have seen almost a revenue plateau happening because we have orders. Like I said, a U.K. order is lying with us, but we are not able to capture in the last quarter. We will be doing partly in Q4 and partly in Q1 next year, even though I had to deliver that way back in December or maximum by January. So these are the challenges I'm already facing in Navsari, which would be, of course, easing off in the next one, one and a half years.
Answering your question, Navsari should be chockablock. I mean, already it is, but I think more if I start removing the domestic also, it should be saturated with export orders only by the end of Q2, Q3 2026, that is this coming year. I'm saying let's talk on the calendar year by around October to December 2025. That is where we will need that capacity for those markets also from Indore. So that is how the thing would eventually, hopefully, plan out, and we don't see any other capacity issues coming in.
Got it. Understood, and Roonghta, second question is just one clarification. When you say that we'll reach a better break-even for the Indore facility by Q4 of next year, does it also factor in the regulatory costs, filing costs, etc., that will be incurring for the regulated markets, or that would be some additional cost that will have an impact?
No, already that is being already. If you see in the last two quarters, we have really increased our other expenses. All that cost has been other expenses have gone to this 45 level. And that will further increase in the next four quarters also because of the thing. So I'm assuming, and again, I'll just ask Roonghta just for this confirmation. But yes, when we see on a standalone basis, we are assuming by Q4, it should eventually start breaking even, and then the actual margin should come. But I think we have considered these costs. Roonghta sir, am I right? We have considered the.
Yes, we have considered all these costs.
Yeah. So I'm saying because already that if you see in the current P&L, already they have started hitting us from last two quarters itself.
Okay. Perfect. And just one last question from my side. I mean, if you could just throw some light on the revenue contribution from a top five or 10 molecules, basically.
Sorry, can you repeat that again? I just got a call in the second. I could not hear your voice. Can you repeat that?
Can you just mention what would be your revenue contribution from a top five or top ten molecules?
So top seven, I just did it because we have seen erosion happening there. So top six to seven molecules contribute to almost 20%-25% of our revenue as of now in various CMOs and all that. So that is something. I would say top, yeah, top six or top seven contribute that. Otherwise, let me get back to you because I don't have offhand. I can get it sent to you.
No problem. No problem. That is good enough. Thank you so much for answering all my questions. That's it. Thank you and all the best.
Thanks.
Thank you. Next question comes from the line of Yash Tanna from ithought PMS. Please go ahead.
Yeah. Hi, Tanna sir. Thank you for the opportunity. I'm Yash.
Yes, please go ahead.
Yeah. So I think one question has been answered. I just have one question. So we created this subsidiary called Gufic Prime Bio recently. So if you can share any developments and what's our plan with this subsidiary. And also, I think you briefly mentioned about Botulinum toxin for international markets, but have you taken a call not to take that international, or if you can throw some light on that as well?
So we had an opportunity some time back to take it international, and it was quite a good idea. Of course, the talks are still on, but I think we never say never because right now, just for the fact that because of the time which is there and our other Indore and the domestic market as well as the US, I would say the validation batches and the European validation batches are taking a big part of the bandwidth. And also, as you must have seen, we just have got a new President of International Business who has joined us, who has excellent regulated market experience, Dr. Raj Shekhar. So our bandwidth is right now fully focused on getting these existing assets working to the best of their ability.
We would, of course, love to go to Botulinum toxin international market, but maybe we feel it would be better suited to all of us that if we do it after one year, once we have all other guns blazing, and then we can start to ignite a new gun, so otherwise, it should not happen that the CEO or the CEO also get occupied in this new thing.
Of course, not me, more than me, actually, my CEO will get occupied in this new bandwidth of setting up a new facility for botulinum toxin and we foresee that maybe in a year's time, there are certain assets coming up where we can actually go with our tech transfer and then start manufacturing rather than creating any taking more debt or creating an asset on our own, which can be a little bit more rather put that money in the regulatory process, the tech transfer, and use that facility to take our Botulinum toxin. So there are a lot of options we are exploring. And keeping in mind the company's bandwidth and our immediate, I would say, targets, we are taking it one day at a time. So let's hope we can share something good with you all in the future.
Right. Sure. Thanks. That makes sense. And anything on Gufic Prime Bio, what's that?
Yeah. So Gufic Prime Bio, basically, since there are, apart from Botulinum Toxin, other products also being made in terms of oral dengue vaccine and oral other vaccines of COVID, and I think now we have also started working on one more option. So those eventually would be, I would say, rooted in a different way because it's a subsidiary because Dr. Balram Singh also has some plans of, I would say, raising capital, which are very preliminary stage because there are certain things which we as Gufic, as a company, can take it to the next level, but at least to certain, I would say, clinical, I would say, roadmap, maybe of a preclinical phase one, phase two, we can do it. Beyond that, how do we take it forward? We will always need external help and external, I would say, interest will drive it to the next orbit.
So Gufic will have limitations to drive a project except in the scientific way because then there'll be more investments involved, and there'll be more and more, I would think, other resources required. For that, we have created this vehicle, and as and when we get a successful phase one or preclinical and phase one and phase two, we will start updating all this better thing, which will again be a good thing. So you understand, right? So we can't take certain projects through and through. There might be a time where we can just exit certain projects at the right time and then give it to the next person to take it to the next level, and then we start working on another R&D project.
Got it. Got it. Got it. Very helpful. Thank you, sir, and best of luck.
Yeah.
Thank you. The next question comes from Shrey Gandhi from C.R. Kothari Stockbroking. Please go ahead.
Thank you for the opportunity. I just have a small question regarding the macro environment. Let's say USA has been planning to put import tariffs on pharmaceutical products. So do we see any impact on that considering our CMO segment from Indore vertical, which is planning to go maybe next year or thereafter?
To be very honest, we are very small, or we have not even entered it, so right now, it will be very myopic of me to comment on this. I need to study more, and I need to research more, and since as a CMO, I'm sure our clients, both Indian as well as international, would be more in tune with this than me, so at this moment, I will not be able to comment because I really have not much idea into this, so I will not be able to give you any structured reply.
Okay. I have another question then. The fixed revenue which we derived from the Indore facility in this quarter, was it from own manufacturing, or was it from CMO vertical?
Yeah, it was from our own branded. Like I said, right now, the first thing you can start is only own branded because other companies will wait for our three batch three, I would say three batches, and then six months data for them to start. So till then, it will be own manufacturing. Even this Q1, I'm sorry, Q4 will also be own brand and own manufacturing. And then hopefully, not hopefully, I'm sure from Q1, Q2, you will see CMO kicking in.
Okay. How much is the expectation in the next quarter from Indore plant?
We are assessing it. Again, it's a very forward-looking thing. So I'll just say that right now, the start has happened. We hope that we can reach at least two to three times than what we did already in this quarter. So just give you an indication around that.
Okay. Thank you. Thank you for the opportunity.
Yeah.
Thank you. As there are no further questions from the participants, I now hand the conference over to Ms. Amisha for closing comments.
Thank you so much. I appreciate all of you joining us today. If you have any further questions, you can contact our IR, Mr. Avik Das. With that, we conclude today's call. Thank you.
Thank you. On behalf of Gufic Biosciences Limited, that concludes this conference. Thank you for joining us. You may now disconnect your.