Gufic Biosciences Limited (BOM:509079)
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At close: May 5, 2026
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Q1 22/23

Aug 12, 2022

Operator

Ladies and gentlemen, good day, and welcome to the Q1 FY 2022-23 earnings conference call of Gufic Biosciences Limited. As a reminder, all participant lines will be in the listen only mode, and anyone who wishes to ask a question may enter star and one on their touchtone phone. To remove yourself from the question queue, please enter star and two. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Ms. Ami Shah, Company Secretary. Thank you, and over to you, ma'am.

Ami Shah
Company Secretary, Gufic Biosciences Limited

Thank you so much, Peter. Good evening and a warm welcome to Gufic Biosciences Limited earnings conference call for Q1 of FY 2022-23. I have with me Mr. Pranav Chokshi, Chief Executive Officer and Whole Time Director, Mr. Devkinandan Roongta, Chief Financial Officer, and Mr. Avik Das from Investor Relations team to give the highlights of the business performance of the company and to clarify all the queries of the investors during the call. After the opening remarks from the management, operator will open the bridge for Q&A session. Before we proceed with the call, please note some of the statements made in today's discussion may be forward-looking and are based on management's current expectation, and this may be viewed in conjunction with risks and uncertainties involved in our business.

The company assumes no responsibility to publish or update or amend, modify, revise any forward-looking statement based on any subsequent development, new information or future events, or except as required by the applicable laws in force. This call is being recorded and the playback shall be made available on our website shortly after the call. The transcript of this call will be submitted to the stock exchange and will also be made available on our website. I'll now hand over the call to Mr. Avik Das for his opening remarks. Thank you all. Over to you, Avik Das.

Avik Das
Investor Relations, Gufic Biosciences

Welcome one and all to our con call. I'll just first quickly summarize how the quarter has been for us and then take a deep dive into each of the divisions. Excluding the COVID portfolio, we've seen a growth of around 20% and we've not only been able to insulate our EBITDA margins in these inflationary times, but we've also seen an improvement in our EBITDA margins. Growth in this quarter was primarily driven by exports and our domestic market. We gained market share in key therapy areas such as infertility, ortho and gynecology, as well as aesthetics. Robust performance was noted in our branded and CMO business via antifungals, hormones and anti-inflammatories. Even our international business, we saw better penetration in Europe and LATAM.

Now I'll quickly take you all through the performance of each of our divisions. Within the critical care division, we've been able to retain leadership position in the antifungal and antibacterial space. As you all are aware that we launched Dual Chamber Bag for the first time in India, initially targeting anti-infectives. The total addressable market over here is INR 3,000 crores. Of course, critical care segment faced some headwinds due to reduced hospitalizations and excess inventory in the channel. But with the launch of Dual Chamber Bags and normalization of hospitalizations, we see growth coming back in the next quarter. In this quarter we've also entered neurology, which is with some unique products and with a dedicated task force. We've also set up a training center. I'll talk about it subsequently on this.

The idea mainly over here is to broaden the addressable market for the product that we've launched in the neurology segment. Now I'll take a quick dive into the Ferticare division. In this division, we will be launching Dydrogesterone. This is a product which is ready to launch. To de-risk ourself, we have vertically integrated with our own API. The market size for this product in India at the moment is INR 700 crore and growing, roughly at 60% year-on-year. We are planning annual sales of at least INR 20 crore in less than two years. As a company, we have also invested in developing a recombinant alternative to the urinary source of a certain hormone, which is very critical in the treatment of infertility.

By doing this, we will be de-risking ourselves of geopolitical issues as well as currency risks, maybe within the next 15-18 months. Broadly, we have the widest basket of products now, in the infertility segment, and we are vertically integrated with our own manufacturing. We have a very strong field presence, and we intend to be among the top three players in India in the next three years in the infertility segment. This is of course a INR 4,000 crore market and growing at 15% year-on-year. Next, I'll take you all through health and spa division. We are of course market leaders in the anti-inflammatory and herbal medicines.

We have initiated trial of a product, which is derived from Indian gum by a standardized extraction process, for management of asthma. This is an extension of our existing product, but targeting a new indication of course, which is a very huge market in India. Our brand in this space, Sallaki, continues to be the market leader in Boswellia serrata range of products. New multivitamins and anti-inflammatory basket will be coming up in the coming quarters and will be driving the growth further in these two divisions. Now in Stellar division, we already launched Sallaki Max, and now we are complementing it with launch of pain management and muscle recovery products. We are also launching a very unique topical oil suspension, which will improve penetration and faster recuperation.

We foresee that this is a very differentiated product and very few companies have it in India, and we foresee growth to come into this division as a result of the combination of all these products. Now, on the international business front, we've seen a growth of around 25% in this segment. We are very proud to let you know that we are exporting to more than 130 countries now. Currently we have 180 registrations, and in the past quarter itself we received 13 registrations, and we've applied for 33 new registrations. We are very, very proud to announce that we've received two product approvals from U.K. MHRA in the past quarter. We've set up our own subsidiary in U.K. to grow this business.

We've also applied for one more product in Brazil. For Europe and LatAm, our strategy is very much in place, which is to take our existing developed formulation in these countries, especially those countries where we already have presence and identify new countries based on market gaps and opportunities. I'll take you all through a brief overview on our idea behind setting up the Center of Excellence in Mumbai. The Center of Excellence will be not only treating your facial skin and body, but it is going to be using the most advanced equipment, toxins and fillers for entire face and body contouring. Through this Center of Excellence, we intend to bring to market some of the most advanced technologies and techniques products from across practices and philosophies and markets as well.

This will be the most panoramic way of approaching your skin treatment and body contouring treatments in India. Moreover, the idea of setting up the Center of Excellence is to promote it as a knowledge repository and make it open and available to all members of the medical fraternity to leverage our findings and showcase the magnificent and marvelous capabilities of botulinum toxins. After this I'll just give you a quick run-through of the Aesthaderm division as well. Stunnox continues its penetration into the Indian market. We are also developing fillers to complement and complete this entire basket now. We've started, as I said, the training center for new therapies with combination of machines and use of fillers and botulinum toxin for face and body contouring.

We've also tied up with experts in the field of vaginal tightening and vaginal rejuvenation and organized training at national level to promote the use of Botulinum toxin for these indications. A quick update on our R&D. Our API R&D at Navsari is doing very well. We have selected the molecules in very targeted therapy segments such as antifungals, antibiotics, and a lot of it will be for backward integration as well. That R&D center and the product development is going on very well. We will be completing the clinical trial for D29 by Q3 of FY-23, and we'll be submitting by around the same time to DCGI for final approval.

This, of course, is a novel once-a-week anti-infective which will be launched for the first time in India. We've also done some interesting work in Biapenem in the last quarter, and we are expecting approval soon, not only in the vial form, but also Dual Chamber Bags. Dual Chamber Bag, we'll be the first company in India to launch Biapenem with. Another thing about Biapenem is that currently the market penetration is quite low due to the unviable pricing. But we intend to use our proprietary technology to reduce the pricing and increase the reach, and thereby increasing the overall market for Biapenem in India. Of course, you know, we've had a very successful launch of Dual Chamber Bags.

We've also shared a link in our presentation, and I'd highly encourage all of you all to, you know, have a look at how beautiful that product is. For Isavuconazole, we will be complementing the injectable form with an oral option as well by Q3 of FY-2023. Overall, the market for this molecule is growing at roughly 100%. Last quarter, we did announcement of our partnership with Selvax, which is an Australian company focused on immuno-oncology. There's a quick update on that. That this particular therapy has demonstrated promising results in two pancreatic cancer models tested in the preclinical stage, and these results align with other different mouse tumor models tested. The current treatment options for pancreatic cancer include surgery, chemotherapy and radiotherapy.

These options are rarely effective, and in most cases are used to manage symptoms rather than eradicate the disease. There's a need for a new treatment that can effectively combat this cancer. Selvax has shown some very promising results. We've highlighted that in our investor presentation as well. A quick update on our CapEx at Indore. The civil construction and site development work is progressing very well and as per schedule. We're very happy to announce that it's nearing completion.

All our equipments have been selected and ordered, and we expect most of these equipment to reach us by September. We are still on track for commercialization of this facility by Q1 of FY 2024. With the Parenteral block at Navsari, our decision to move it to Navsari has played very well given the timing, the time that we've saved and our ability to leverage the existing utilities around. The civil work is completed, all the equipments have been received, installations have been completed, and we are absolutely on track to hit commercialization in this month itself, which is an announcement that we made earlier. With this, I hand over the call to our CFO, Mr. Roonghta, to give you all a brief overview of the numbers for the past quarter.

D.K. Roonghta
CFO, Gufic Biosciences

Thank you, Avik. Good evening, I'm Mr. D.K. Roonghta, CFO of the company. I'll be going to highlight the financial performance of the company for Q1 of financial year 2022-23. First, I would like to inform you that in the Q1 of last year, that is 2021-22, the sales was INR 252 crore. This includes the COVID sales of around INR 113 crore, COVID-related products. If I remove the COVID-related products, the net sales without COVID was around INR 139 crore. Against INR 139 crore, this quarter the sales is around INR 165.70 crore, that is around 20% jump on the top line. Both the quarters figure are not comparable because of the inclusion of COVID-related sales of around INR 113 crore, so I'm making a comparison between the Q1 of 2022-23 versus Q4 of 2021-22.

The total revenue for the Q1 of this year is around INR 165.70 crore, where the subsequent Q1, that is Q4 of 2021-22, was around INR 152.2 crore. EBITDA for the current quarter is around INR 33.6 crore, whereas Q4 of last year was around INR 31.6 crore. The EBITDA margin in current quarter is 20.3%, in the last quarter of last year was 19.5%. There was improvement about 80 basis points. Profit before tax has improved from INR 26.2 crore to INR 28.3 crore. PAT margin has improved from 16.1% to 17.1%, and profit after tax has improved from INR 20.3 crore to INR 21.1 crore. PAT margin has further improved from 12.5% to 12.7%.

Q1 of this year versus Q1 of last year is not comparable because of sales of COVID of around INR 113 crore. Thank you very much. I request Pranav Sir to take the

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Thank you, Roonghta sir. I think, Peter, we'll directly go to the question and answer, right? I believe, that's the normal protocol.

Operator

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 the touchtone 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. Our first question comes from the line of Girish Gulati. An investor, please go ahead.

Girish Gulati
Investor, N/A

Hello. Hello, can you hear me?

Operator

Mr. Gulati, your line has been unmuted. You can proceed with your question.

Girish Gulati
Investor, N/A

Please, please. Thank you. Pranav Sir, first of all, hi to everybody, to Mr. Roonghta, Mr. Pranav bhai, and Mr. Avik as well. My question is that, regarding the pancreatic cancer, what are the updates which we have and are we trying to target any hospitals yet like AIG Hospitals is there and PSRI Hospital is there as well?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah, Girish Gulati, good afternoon.

Girish Gulati
Investor, N/A

Good afternoon, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Good evening. Yes, in terms of the therapy, what we normally do, we are currently following certain animal models as per the regulatory pathway.

Girish Gulati
Investor, N/A

Mm-hmm.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

First we have to always like, you know, Avik also, you know, commented, we have to start with some animal studies and then only we are allowed to take the permission of the government to perform certain human studies. Of course, assuming it's an oncology product, the permission a little bit fast track, but it goes through a protocol. As of now the status is that, you know, as we have mentioned, these are mostly for solid tumors, the entire immunotherapy which we are working on. We had already got good results in some species of animals that is, you know, dogs first and then mouse and all that.

Now the recent update which has come is in regard to pancreatic cancer, again being a type of a solid tumor, but more importantly it's a different type of tumors which we got a sort of a higher percentage of remission which is not possible in the conventional FDA-approved therapies also. Answering your question, sir, yes, the moment we get the permission, moment we submit our data to. Right now it's with the Australian government. We will be starting the journey to the Indian government, once we get the tech transfer is in process and we will get.

We get a final formulation, we do the tech transfer, and then we will be applying to the Indian government to either allow us to go for a direct phase three or maybe they might ask for a phase two. If not, I don't want to do any animal studies here in India 'til the entire concept has been fully proven. We are looking at least some time off 'til we start the human trials in India.

Girish Gulati
Investor, N/A

Because, see, why I was asking this is pancreatic cancer is usually unsolvable disease.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes. Yes.

Girish Gulati
Investor, N/A

If we come out with a medicine which is, you know, can take care of it.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes.

Girish Gulati
Investor, N/A

Usually it is fatal only.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Girish Ji, you very rightly said.

Girish Gulati
Investor, N/A

Yep.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Very rightly said, yeah. Pancreatic cancer, I would say, is one of the difficult cancers to treat. You know, like you rightly said, you know, it is having its own challenge. We hope that, you know, with such good data in the animal models, we should get a fast-track response to do some trials earlier in, you know, the Indian market also. I agree with you. We should try to push it, and we already are trying to push it to get some earlier response. We'll be submitting to the DCGI very soon.

Girish Gulati
Investor, N/A

Good luck, sir, because that's a very, very challenging disease actually.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Thank you, sir. Thank you, Girish Ji.

Girish Gulati
Investor, N/A

One more follow-up was, in the last, I think, Q3 call you mentioned about indoor facilities you'll be coming up with vaccine and GDAs biotech and peptides.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Yeah.

Girish Gulati
Investor, N/A

Just because this is an area of your interest, so I just wanted.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Right.

Girish Gulati
Investor, N/A

A bit brief on that, sir. Yeah.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

As you rightly said, sir, we are already launched the peptide forms. The recombinant protein or recombinant hormones are something which Avik also spoke about. We are trying to get in the next 15, 18 months, maybe one product before that also. The oral vaccine technology is something which we already have applied the proof of concept to the DCGI in February, and we have got a reply in some months ago, and we have replied back to that also in the month of July. We are hoping for another lineup maybe in the month of August how to take it forward. We are going to apply in the month of October for one more candidate of the oral vaccine technology to the DCGI.

Knowing the timelines, like I said, vaccine will be little bit more long-term in terms of the regulatory cycle as compared to the recombinant proteins, because they're already generics. I would say, it will be more of the recombinant products are mostly like biosimilar, whereas the oral vaccine technology will be a completely new technology on its own. I foresee some, I would say, extensive regulatory pathway, which is fine and we accept that and we want that to happen. We ensure that the product is completely safe and effective. But it is exciting. I hope you know that oral vaccine, when the time comes up, at least the preliminary, preclinical, then animal and phase II, you will be hearing some nice, you know, updates from us.

Girish Gulati
Investor, N/A

Wonderful. Sir, on that platform of biotech, sir?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Biotech, like that part. The biotech is entirely about recombinant proteins, oral technology and immunotherapy of the tie-up with Selvax. These are the three things which we are working on in the entire thing of biotechnology. Apart from of course the peptides, which we already mentioned we are doing work on, you know, recurrent implantation failure and endometriosis. All of this comprise the entire biotech headspace of, I would say, the entire, you know, entry of Gufic into this sector. All three. All four of these things.

Girish Gulati
Investor, N/A

Perfect. These are very challenging, and I wish you good luck for this, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes, sir. Thank you for your patience. I take this opportunity. I hope you have patience with the company because these are long-term, but we are really having their own trajectory. We will go step by step and we'll ensure that we do it the right way.

Girish Gulati
Investor, N/A

Great, sir. We are always there to support you as a part of Gufic, sir. Thank you, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Thank you. Thank you.

Girish Gulati
Investor, N/A

Thank you so much.

Operator

Thank you. Our next question comes from the line of Rajat Sethia with iThought PMS. Please go ahead.

Rajat Sethia
Co-Fund Manager, ithought PMS

Hi. Thanks for the opportunity. My first question is about the Dual Chamber Bags, which we say is a INR 3,000 crore opportunity. Can you please highlight who are the major competitors and what's their market share?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Rajat Ji, good evening. When we say INR 3,000 crore market share, we specifically refer to the conventional dosage forms which are available in the form of penems, penicillin-based antibiotics and also some, you know, I would say Gram-positive antibiotics. To name a few, we are talking about Meropenem, Imipenem, Biapenem, Doripenem and Ceftriaxone, Piperacillin-Tazobactam and Vancomycin and Teicoplanin. These are currently available in India. I'm again talking specifically for India, only in the form of the normal vial.

You have a glass vial, you have a rubber stopper and I would also once again take this opportunity for you all to refer to the link which Avik has mentioned because, you know, I'll try to explain to my level best in the call, but once you see the video which we have uploaded on the presentation, it gives a very good, you know, three-D, which a lot of audio visual representation of what the technology is about. Currently, the product is available in the vial and the entire medical...

The nurse, midwife and the medical fraternity takes approximately 3-5 minutes, depending on their time, to reconstitute each product, which might lead to cross-contamination, inaccurate dosing, or in some cases, some, you know, other, sort of a contamination because of air or because of some using the wrong needle or the wrong diluent also. With this technology of dual chamber bags, we have ensured that the entire drug remains in a very enclosed way and that it's not exposed to atmosphere, and the entire reconstitution happens only in around 20 seconds as compared to the 3-5 minutes. Imagine in today's scenario, when the workload on the nurse is quite, I would say high, because she has to handle. In any ward you see, the nurse to patient ratio is quite high.

They are apart from just treating them and serving them, they also have to take care of documentation, which is a big thing as per the new guidelines also. If we can save, you know, around 3-5 minutes per patient, and maybe a patient has to be administered medicines on an average around 3-4 times a day, I'm saying on an average, we are saving a decent amount of time for a nurse. In some cases we have done some excess around one and a half hour of a nurse is saved on a daily basis, which we can, you know, either spend on the documentation or spend on herself to just, you know, take a break and relax. More importantly, the cross-contamination which happens in the ICU setup, where you know the drug because of the.

A lot of people have different diseases and different conditions. Since the entire Dual Chamber Bag is enclosed, there is no air hole or there's no pinhole or there's nothing else which comes in open. The entire drug goes into the IV in the form of an enclosed system to avoid any sort of exposed contamination. We refer to this technology as a new thing which has been brought into India in form of this. At the same time, I would like to be very upfront. This technology is already available for some products in the U.S. and the European markets. However, the price is almost 3-5 times the cost of a conventional product, which makes the product not viable, and that's why it's not picking up.

We are proud to say that we have launched the current product with only a price expense of around 15, you know, 15%-20% in some cases than the conventional drug right now, for these products in the Indian market. We foresee that after, you know, maybe after a year or two, once we reach economies of scale or maybe earlier than that, we foresee that we can make the cost of the Dual Chamber Bag almost same as a conventional vial, which will be a big revolution. This is the product which we are talking about.

Rajat Sethia
Co-Fund Manager, ithought PMS

Okay, this is really very helpful. Thank you. Basically, of the INR 3,000 crore market, some is dual chamber, which has just started, and rest is conventional vials. How much would be dual chambers at the moment?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

The entire INR 3,000 crore market is conventional vial only. We have launched the product just right now, so we are the first one to come to dual chamber and then we will be taking a market share from this. We are the only one in India with a dual chamber bag. No one else.

Rajat Sethia
Co-Fund Manager, ithought PMS

Okay. Imports are also not happening for this kind of product?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Imports are happening for liquid total parenteral nutrition, which are triple chamber bags. No one in India as of now has a powder liquid dual chamber bag, which is the most unique and complex thing, only Gufic has. Gufic is gonna do that via their own, and also we wanna give it to one, two of our associate clients to bring up the concept molecule-wise.

Rajat Sethia
Co-Fund Manager, ithought PMS

Understood. What kind of revenue potential you see for yourself in next two years from this product itself? Is the Dual Chamber Bag that we have launched the only product in this category or you think there will be more variants for different to address different kind of therapies?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Always. Anything which can be done intravenously we can do in this product, all the way from 50 milligrams to even 5 grams. All the way from 25 ml to 100 ml. We can always have these permutations and combinations, and we have the capacity to back it up. Answering your question, I have an internal target of the market share, but I'll refrain from doing that. Like I said, we are working on so many things. You know, something works at this time, something works at that time. Overall, our target of minimum 15%-20% year-over-year revenue jump will be coming. This product will be playing quite a big role along with the indoor facility also.

We foresee that we should, as it is, try to take as much as market share as possible. Again, I cannot give you numbers as of now because it'll be too, I would say, wrong on my part. Give me a quarter, I'll see the response and I'll give you a much more solid number by then.

Rajat Sethia
Co-Fund Manager, ithought PMS

Are you seeing any more people entering Dual Chamber Bags in the immediate future?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

As of now, no. I don't see because for us it at least took us four years to actually get it done. Because we got the entire thing from Europe. We had to do something indigenously all the way from mold making to stabilities and all that. I think if anyone wants to follow the right European and the international or US way of launching a product which we do, then I don't see a competition at least for the next two years. However, I've seen in India, people do shortcuts and come up with inferior products, which I cannot comment on. As of now, I don't see any shortcuts of inferior products coming in. If anyone has to do and launch a product our way, minimum they have to work two years from now, if they have to start. Minimum, I'm saying.

It must be more. Because at least we will be a, what do you call? A blueprint for people to follow.

Rajat Sethia
Co-Fund Manager, ithought PMS

Okay. Thank you so much. Really appreciate your answers. Thanks.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Rajat Sethia
Co-Fund Manager, ithought PMS

Just one small thing, if I can suggest.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Sure.

Rajat Sethia
Co-Fund Manager, ithought PMS

In the opening remarks, if we can cover something which is not already mentioned in the presentation, that will give us more time for the Q&A. Thank you.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

No, I agree. You know, then, you know, we have got a question that I hope people like you at least read the presentation. A lot of people just meet us without the presentation, that's why we do it. I got your point. What we can do, we can maybe shorten it up little bit and we can spend more time on Q&A. I got your point. Thank you.

Rajat Sethia
Co-Fund Manager, ithought PMS

Thank you so much. Much appreciated. Bye.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Operator

Thank you. Our next question comes from the line of Subramaniam K with Alpha Invesco. Please go ahead.

Subramaniam K
Market analyst, Alpha Invesco.

Hi, Pranav, sir. Good evening. Thanks for the opportunity. My first question is, assuming the total market size of Critical Care is INR 5,000 crore, which is mentioned in the previous call, and as we have a lot of things lined up like dual chamber bags, Airvo, et cetera. Currently we have 4% market share, which is INR 200 crore sales in FY 2022. In the Ferticare we have 3% market share in the INR 3,500 crore total market size. I wanted to understand what are your aspirations moving forward and when can we see the double-digit market share capture in each division?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Subramaniam K, firstly, I would like to compliment you for your percentage. You know, I think, precision. I don't know. Even I don't know if what the percentage you said is right or wrong, but I like to compliment that. Coming back, I think in a market like India, sir, only innovation will bring that double-digit, you know, I would say market share. If you see the IQVIA numbers also, you see the entire market, you know, of INR 1,80,000 crore, which according to IQVIA is there. I'm not giving you any number from my mind. If you see the number one company still would be around 8%-9%. I'll still correct myself.

I think I'll wait for Avik to maybe see the IMS data and inform me what is it correctly. I would of course love to have double-digit market share in India and I think you rightly said in critical care and in infertility it is possible because of certain launches which we have planned in the next few years. As Avik mentioned, I will first talk about infertility. As we see the market, what the market of infertility products will be much higher. When we give you a certain number, we only talk about the represented market where our molecules are present. Let's say if we launch a progesterone, I will only talk about a progesterone. I will not talk about a dydrogesterone. But if I talk about dydrogesterone, it will also include only dihy.

That way considering that, we feel in a represented market share, we hope in the next 3 years we should have more than definitely a double-digit. Maybe in the next 2-3 years, we should have a double-digit market share in the represented market for sure. Coming to the critical care, you rightly said if you see critical care is very unique because, you know, all the way from anti-infectives, then, you know, anesthetics, cardiac, even neurological, even parenteral nutrition, anesthesia, a lot of things come in critical care. The INR 5,000 crore market, which I was representing is again related to the represented market where we have molecules present.

We have plans now from Indore factory and from the Navsari factory to actually go and gradually address in the next three years, a INR 25,000 crore market share where we have listed out molecules as per IQVIA's. We're trying to go a little bit on a penetrative model where we get into all primary, secondary and tertiary hospitals via a different alternate model of end-to-end. Again, I'm saying that as my molecule launch, launches go up, I will be always increasing my represented market from a INR 5,000 crore to a INR 25,000 crore.

Even though in the represented market I might be getting into double digits, when I increase my market share to INR 25,000 crore, I might again come in a single digit after 3 years because of, you know, there'll be new lines launched. As a molecule-wise, I would like to share with you in some example, we are the number 1 company for some echinocandin. We are the number 2 company for some antibiotics. We are the number 3 company. Because of these individual molecule markets, we already might be in double digit right now itself. We might be in certain cases maybe 20% of the market share. In certain cases we might be 33% of the market share also.

It's a very different, difficult way for me to answer your question, but I hope I have done it in my best way possible.

Subramaniam K
Market analyst, Alpha Invesco.

Thank you, sir. Thank you. It has given me the understanding of the total addressable market, how to like, how you are projecting yourself.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Subramaniam K
Market analyst, Alpha Invesco.

Okay. I will go ahead with the other division. I want to understand what are the challenges in making Sallaki as anchor product sales product. If you see like area, as you are using 30% of field force in healthcare division, which is highest among other division in terms of its field force usage and sales.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Subramaniam K
Market analyst, Alpha Invesco.

Our field force is low compared to industry standard.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Right.

Subramaniam K
Market analyst, Alpha Invesco.

Do you have any other anchor product in pipeline which can replicate Sallaki?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

I think very good question. I think this is a very good question which I ask myself in the marketing again and again. If you talk about nonsteroidal anti-inflammatory products, you know, you have the Diclofenac and Aceclofenac which is a very big market. If you see a Boswellia serrata, maybe it might not have an analgesic effect as much as a Diclofenac would be. The long-term use of a Boswellia serrata and the safety and the benefit of a Boswellia serrata as an anti-inflammatory is far, far more than these other NSAIDs. The problem what I feel, and this is my own personal opinion, please take it in that way.

Normally, when anyone goes to a doctor, the doctor wants the person first to be relieved of pain and that's why there is always importance that you have to give an analgesic first, followed by anti-inflammatory. For us, we are in the last 3-4 years also trying to endorse that, you know, let's say the Ayurvedic experts already established the product and we have a particular scalability in place. For us actually to go for a genuine high scale of INR 100 crore or INR 150 crore reach, make this entire Boswellia serrata market, forget just Gufic Sallaki.

If we want to make the Boswellia serrata market in multiples of hundreds of INR crores also, we need to do many more clinical trials and training sessions for the orthopedic doctors and the decision makers of KOLs who actually are the main primary treatment leader of rheumatoid arthritis or osteoarthritis and ensure that how we do that. We are trying to do that in the last two, three years. It's not easy. You know, we try our level best to do trials. We try our level best to do, you know, symposiums and we try to do, you know, training. I would not use the word training as the right word. Basically it's just informing and, you know, telling the doctor how the product can help ensure that they try to do it. Even the

If you see the cost of therapy of gum and the long-term management of the disease is much, you know, convenient than doing any other thing which is available in the form of, you know, the modern medicine also. However, I'm not here to debate the pros and cons of either, but I would like to say that our efforts are on. We hope that via doing more clinical trials, via doing more, you know, studies with different institutes and key opinion leaders of India, we want to confirm them that the Indian alternative as an anti-inflammatory is very good. Also, I'll tell you one more challenge which we had in the middle.

Since our product was an Ayurvedic proprietary medicine, there was a rule in some states. Again, I'm telling you what information we have and you can check it up on your own also. A lot of allopathic doctors are not allowed to write Ayurvedic products, and Ayurvedic doctors are not allowed to write allopathic products. This is something which we always, you know, try to go and change and, you know, talk to the government and do it. Of course, government is helping us a lot also because there's always benefit in either. We cannot say that, "No, this is important, that is not important." Now since for Sallaki, we have actually proved the product as a modern medicine. You know, we have worked on the pharmacology part of it. We have worked on the pharmacokinetics.

We have done so much work on. We also have worked on the mutagenicity of the product also, which we have used this data to register products in countries like Germany and Switzerland. If modern doctors from Germany and Switzerland are allowed to write this product, we also have made a representation to the Government of India and they are helping us because they also want to promote the Ayurvedic product use wherever science is involved. I'm not talking about all Ayurvedic products, but wherever science and data is there, they are backing us to also make other doctors use.

I hope in the near future, if the modern doctors try our product, use our product, which we of course will work a lot for that, and if they're allowed to prescribe our product, I don't foresee why not Sallaki becoming an INR 100 crore product very soon. Because it's been. It's standard. It's been there for 20 years. It's become more than an INR 30 crore product. I hope very soon. I think it's more than an INR 30 crore product, but I hope very soon we can extrapolate it to much higher numbers.

Subramaniam K
Market analyst, Alpha Invesco.

Thank you very much, Pranav sir. This is a mind-blowing explanation for the history between Sallaki and the market dynamics.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Subramaniam K
Market analyst, Alpha Invesco.

We are focusing only on Sallaki because we are having more than 30% of the sales force. Like, is there any other product, like, as you are facing this Ayurvedic challenge with modern doctors, do we have any other products in pipeline?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes. Yes, of course. We have multivitamins, we have products for kidney stones, for any stones, and we also have products for, you know, our Kofend, which is a combination of honey and, you know, what do you call, our other conventional forms. They are also very good. We have some more than, I think, around 24, I think more than 18 products and more than, I think, 24 SKUs, which is part of the division. We also are launching some new innovative, I would say, options for cardiac treatment soon. Of course, it's no use just launching a product on concept. If before launching any product on concept, we do try to do some clinical trials and we do some data. At least, you know, it helps to convince the doctor with scientific data.

Otherwise, you know, there is a plethora of products in the market which just makes claims, which has no evidence. Ayurvedic products will improve in India only once they are backed with scientific data, and that is what we are trying to do step by step.

Subramaniam K
Market analyst, Alpha Invesco.

Okay, sir. Okay. Thank you. Thank you very much.

Operator

Thank you. Our next question comes from the line of Bhavya Sonawala with Prime Asset Source. Please go ahead.

Bhavya Sonawala
Analyst, Prime Asset Source

Yeah, good evening, sir. Thank you for the opportunity. Just to understand, I know you have iterated this before, but just to understand again. According to you, what, you know, what is our differentiating or the unique factor? Is it that, you know, we are able to pick the right drug and get it in our, you know, using lyophilization as the process? Are we trying to come up with new drug delivery systems? Just trying to understand what is our macro strategy to grow all our, you know. We have many growth levers, so what is our strategy and what sets us apart? Thank you.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

I think that's a very long question to answer. I think I can finish the entire call on this question, but please I'll try to do my level best, how do I answer that. Sorry, you would like to say something, Bhavya? Please, yeah, then I'll talk.

Bhavya Sonawala
Analyst, Prime Asset Source

No. Nothing. Sorry, sir. Yeah.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Like I said, so something, you know, is a legacy business of Gufic, which we are trying to do in our own way and take it forward. At the same time, we know there are certain growth levers which immediately help us for the scalability, like the lyophilization, the critical care and the fertility. Then we're looking at a long-term picture of Gufic also, which is beyond, which is fully innovation-driven. When you take any company cycle, and I'll explain to you. We had some legacy business of Ayurveda, nutraceuticals and consumer. We got out of consumer and we stuck with Ayurveda, and we launched modern products. Then we got into life-saving injectables, which helped us scale through.

Now that business is doing well and we now are looking at, you know, from India we went to other geographies, and then we went, of course, backed with better regulatory facilities, first in Navsari, increasing capacities, then went to Indore, which will come from April 2023, which will be additional capacities plus new geographies. Maybe certain markets, like our Navsari factory is approved in all countries except U.S. and Japan. It's, we already are exporting to all the countries as what Avik Das already mentioned. With Indore coming up, we are not only doing lyophilization, we are doing pre-filled syringes, we are doing suspensions, we are doing depot injections, we are doing liposoluble injections, we are doing, you know, certain ampoule complex molecules also. There'll be a separate setup in Indore down the line for biotechnology.

Wherever the company matured, the ideas are there, but depending on the cash flow and depending on how much the company can, you know, punch above its weight, that is what we are trying to keep that balance going on. You know, there might be amazing ideas. India is not a market where if you have ideas, you can just go and get a PE fund and, you know, go and just become a one product company. Always the balance sheet and the, you know, the numbers always matter. Luckily, for us also with Roonghta sir and their team, we are very disciplined in our approach in terms of what we can do and when we can do. That's why many people see Gufic as a multi-lever growth lever company, and say, "Why are you doing so many things?" It's not.

The basic essence of Gufic is innovation. It was innovation in Ayurveda with scientific data. It was innovation in injectables in terms of not only product basket, the economics of scale, but also the pipeline and now also, I would say innovation to some extent in terms of execution to get into these multiple countries where we can take market share and using our economic of scale and other levers, maybe go for a better penetration and, you know, for a higher scale. Coming to the third point, which is I am a B.Pharm and MSc in biotech. I always feel that going down the line, conventional products are very good. They will have their own trajectory. At the same time, you have to work on something unique, which we started off.

Even the Botulinum toxin was something unique, which we started working in 2016, 2017. We eventually launched in 2021, and now that will have its own growth story. It'll take time, but because we have to drive and, you know, educate the culture and the entire thing in India, which takes time. Because, you know, it's not an overnight thing where we have to create a market with science and we have to create a market with trials and training and all that, which we are interested to, because we know that it's not a conventional competition where suddenly, you know, once we launch, 20 other people will come and, you know, take the market share.

Here we will create a market where we try to be the leader down the line, and we know that because of the gross contribution and the backward or vertical integration, whatever we call it, we will be a strong player for years to come. Similar with the biotech programs of immuno-oncology or with the vaccine technology, we want to work on unique things where, you know, with the help of patent protection, with the help of IP protection, we can offer solutions which can help us for higher scalability in, of course, the budget which we have and something which can put Gufic in a different orbit in terms of the reputation of innovation, that's all.

All of them are part of the essence of, again, innovation and, you know, science, which is the core backbone of the company, and we do it in our way step by step. I cannot just start burning, you know, INR 300-INR 400 crore cash on any unique product and start waiting for that. We do it in the right way and take it forward. That's why you have these, you know, different growth levers, which will have their own, what do you call, roadmap, but eventually they will be branching out from the same, I would say, echoes of innovation.

Bhavya Sonawala
Analyst, Prime Asset Source

Oh, thank you, sir. Thank you so much for the explanation. Really helpful. Thank you.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Operator

Thank you. Our next question comes from the line of Pujan Shah with Congruence Advisers. Please go ahead.

Pujan Shah
Equity research analyst, Congruence Advisers.

Hello, sir. I have a few questions. First of all, it's about Dydrogesterone. In presentation, we are saying that it is a massive market size of INR 700 crores and growing at 60% YOY. We are targeting just only INR 20 crores in less than two years. Like, is this market too concentrated or like, it's a high entry barrier to get into this product? Can you just give some justification over this?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Sure, sir. Basically, sir, Dydrogesterone, before 2 years was a market only of 1 or 2 players. Duphaston of Abbott was the only molecule which was ruling the market at least for 3 years or 4 years before. I think Mankind came and did a wonderful job and, you know, could crack the molecule first. Now, of course, as you rightly said, yes, there are around now 3 or 4 players, and it's a very complex product to work on. It uses some principles of photoreactor cell and all that. It's not a product which can be just done as a conventional pharma product. Now, why everyone is interested in it, even though there are around 6, 7 players in the product is because if you see the Indian population and you see the use of a progesterone.

Basically Dydrogesterone is another molecule as an alternate to a progesterone, which is naturally, you know, possible and it is something which helps in not only pregnancy, but also in infertility also. It's one of the treatment options beyond infertility after the infertility is taken care of, and then you have to maintain the pregnancy. The use is almost for a long period of time. Hence, we feel with our field force and our focus is mostly on infertility right now, and eventually, if we can do a good job in gynecs, then of course we foresee our market share will improve.

Right now with the infertility segment where our strengths are and with, because we might be, you know, not the, in the first three or in the first five companies to launch this molecule, we are looking at a, I would say, very fairly conservative outlook of INR 20 crore in the first two years, because we foresee more and more competition coming in. In India, the market is very different. In India, such molecules, you will see maybe someone launches and then you will see 100 companies just fall in maybe in a period of two years. That's why, we always become conservative and we don't go overboard because then, you know, we do never know how the outcome will come. One advantage what we have is, you know, we are backward integrated. There are very few API manufacturers of it.

We hope that although even though as a brand we might not be able to do much or we might try, but there might be always this clutter and prescription war happening, we might always focus as an API supplier. That is another business model we are looking into if we cannot cut it down. Because like we said, we already have lot of, you know, I would say, focused things which we wanna get into, and this can be an add on, but where we can have more focus on the API supply rather than the formulation also, or let's see how it goes.

Pujan Shah
Equity research analyst, Congruence Advisers.

Okay, sir. Thanks for the detailed answer. My second question would be on Isavuconazole, which is an oral option, so market is growing at 100%. Is this like Can you just give us the market size, like what will be the roughly market and how, like, how it is evolving and just give some option, like giving us, how it's been transiting or taking some market option over, or overlapping some market over there?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. To understand this market, you have to understand two points. Isavuconazole injection and oral was launched by the innovator only 1.5 years ago, and it was launched in a good time because for the people of India, because you know, after COVID, there's a mucormycosis which came. In mucormycosis, along with other products like liposomal amphotericin B or other products like voriconazole, or other products like even echinocandin. This was a good product of choice along with posaconazole also. There was only the innovator player who was still available in the Indian market till now. We were the first Indian company to get the permission from DCGI this year in 2022, and we launched the product just 2 months ago.

I think 2 or 3 months, which was mentioned in our, I think, last quarter call. We just have an injection right now and we're now looking forward to launch the oral. The oral use is almost three to one in terms of the injection use. We foresee that with the oral becoming more affordable for the people of India than what is it right now in the market, we foresee that the market of, you know, certain specific fungal infections will be getting, I mean, where patients have a challenge or doctors have a challenge because there is not much, you know, I would say there might be either resistance or there might be some challenges in terms of treatment. This can be a very good effective weapon for us to address that.

Right now, the market being small, I look at the market itself as per IQVIA IMS might be not only INR 30 crore, it's only been 1.5 years. You can imagine in 1.5 years, only with the innovator at such a high pricing, it's become INR 30 crore or I think INR 25 crore or INR 30 crore. It's growing, it's doubling up every year. We foresee down the line, when I compare this market with the other, antifungal market which is quite huge, then we will see that this molecule will take more and more market share and it has a good scope to go much higher.

Pujan Shah
Equity research analyst, Congruence Advisers.

Thank you, sir. Just, like a compliment for Dual Chamber. Actually, I saw the video and it's a fabulous product. Hope so it gets a good traction in the market.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Thank you, sir.

Pujan Shah
Equity research analyst, Congruence Advisers.

Sir, one of the point I just wanted to highlight is, we have given a breakup of domestic business and total revenue, but we haven't placed it percentage-wise. Can you just give me the split of this, percentage-wise, if you can, for Q1?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Of the domestic business?

Pujan Shah
Equity research analyst, Congruence Advisers.

Domestic business breakup. We have presented in the presentation, but the number is not been given.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Okay.

Pujan Shah
Equity research analyst, Congruence Advisers.

The percentage part has not been given.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Always if you see the domestic business is always around 50-55% of our total revenue anyway.

Pujan Shah
Equity research analyst, Congruence Advisers.

Okay.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Pujan Shah
Equity research analyst, Congruence Advisers.

Could you just give us the, like the split of the critical care, insulin and others. Like, we have been given the split, but actually the percentage-wise we haven't given on that split.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

I think offhand, sir, for the quarter itself, I might not be aware about that. What I can do, I can ask Avik to specifically send you, so that'll be a more precise answer than what I'll tell you, which might be a little bit offhand, which might not be precise. Is that okay with you?

Pujan Shah
Equity research analyst, Congruence Advisers.

Yes, sir. Okay. Okay. That's fine. Thank you, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Thank you.

Operator

Thank you. Our next question is from the line of Ankit Minocha with MRLR Capital. Please go ahead.

Ankit Minocha
Founder, MRLR Capital

Yeah, I agree, and thanks for the opportunity. I thought that it was a decent growth in EBITDA margins this quarter. Is this EBITDA margin of 20% sustainable for the coming year? Is this kind of the range that we should be looking at? That's my first question.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Ankit, I think I'll request Roonghta sir to answer that question, will be more, I think, adept than me. Roonghta sir, can you please take this question?

D.K. Roonghta
CFO, Gufic Biosciences

Hello. Can you hear me, sir?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes, sir. We hear you answer.

D.K. Roonghta
CFO, Gufic Biosciences

Last year our average EBITDA margin was around 18.7%. Last Q4 of 2021-2022 was around 19.5%. This quarter it was 20.3%. We feel that looking to the present current business trends scenario, we will be able to maintain the EBITDA margin for this year at least 20% and it can go up to 21% also, depending upon the product mix and prices in the international market of the API purchase. I can say that after Indore coming to play in 2023-2024, there will be pressure on the EBITDA margin because the capacity utilization in first year will be around 30-35%. There will be pressure in the 2023-2024 of the EBITDA margin.

It will be around 20% or it may fall to 19% also because of the burdens of finance cost depreciation and capacity utilization will be only 30%-35%. After 2023-2024, we expect the EBITDA margin in long term they're going to be improved by 100 basis points year-over-year, at least for 2-3 years. That will be the overall expectation of the EBITDA margin depending upon the present business conditions.

Ankit Minocha
Founder, MRLR Capital

Right. Thank you. Thank you. That's a very comprehensive explanation. One of the additional, it's actually very exciting to see the unique opportunities that you're working on as an investor. If I ask you about the core business, I mean on lyophilization, for the medium term, how do you look at that for the next five years? I mean, how does the growth for lyophilization look from an Indian and international perspective, maybe I would say five, seven years down the line?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. If you honestly ask me, it's still my go-to thing because and I'm very bullish about it. I'll tell you some reasons why. You already saw the potential of the lyophilization masterpiece of Gufic last year. When you saw just a molecule like Remdesivir, and of course, I hope and I pray to God that we don't see any pandemic in the near future, and I hope we don't do that. You saw the capacity of the company to handle such a pandemic when you saw a company which is growing by 300-400, 400-500, and suddenly they're going to close to INR 790 crores. That was scalability what we have. Even without any pandemic or something, the organic growth of the injection market space is anywhere around 12%-13%.

I'll come to the international market later. I'll come first to the Indian market to tell you what I mean by the perspective. If you see the Indore factory, what we are coming up, it's gonna be almost two and a half times the capacity of what we have in Navsari, and that's not something great.

If I'm assuming there are 7.7 or 7.8 billion people in the world and 1.3 billion people in India, that 1.3 billion people, the access to medicine in terms of the number of hospital beds, if you just see the reports of the number of hospitals which are coming up all over India, you know, and not only focusing on the tier one cities, the tier two cities, we foresee that the ICU market and also the general ward market to be much higher. Gufic, and I mentioned this in one of the answers before, we were right now addressing only an INR 5,000 crore representative market. We have a pipeline of making this INR 5,000 crore market.

Look, in today's term, out of the INR 1,80,000 crore, till around two Quarters back, we were representing INR 5,000 crore in terms of critical care. Now, with Dual Chamber Bags coming in, with Darbepoetin coming in, with now some other molecules planned, we have planned around some another 140 molecules to be prepared and launched in the next, I would say 2-3 years. We are looking at this five thousand market, five thousand crore market to be actually more twenty-five thousand crore market as on now. The twenty-five thousand crore market anyway is growing at around maybe 10%-12% year-over-year.

We foresee that if we come up with keeping lyophilization as the backbone, keeping in mind just the product extension to support that lyophilization in terms of pre-filled syringes, ampoules, suspensions, vials, dual chamber bags, and so on and so forth, we are quite bullish about that in the Indian market also. Now, let's take the international market. Gufic has only touched markets like Germany with only two molecules as of. When I mean two molecules, maybe four products, but, I'm sorry,three molecules, but out of that only maybe 6 SKUs. What we have a product basket in India, if we can start extrapolating this product basket to maybe Germany, to Portugal, to UK, to Brazil, to Canada, to Russia, wherever, where we already are present, you see that's a separate market share we are going into.

India might be still ranked around the 12th-14th country in terms of value. Again, correct me if I'm wrong. This is what I saw in some data some time ago. Even there are other markets like Europe, which have maybe a better pricing, or even let's say even if the pricing goes down, it'll be still much better than what we are getting in India and having good volumes there itself. We are quite bullish that right now where we are present in multiple countries, but only having two products or five products or seven products, and I'm talking only regulated markets. Let me come to the semi-regulated later on. We foresee a big thing coming there. We are...

In India it took us some, you know, almost the last 6-7 years to develop a strong pipeline, and now because of the money and the cash flow coming in, we have a faster onset of increasing the pipeline. Along with the Navsari R&D, now we have an Indore R&D. With these two R&Ds, we are churning out new products in terms of dossiers, in terms of things, you know, month after month. The time of us having a bigger basket in these multiple countries just keeps on going more and more. That's why I think answering. I will not take much of your time, because I know there are other questions. I'm getting messages that please wind it up.

I'm just saying, lyophilization, and I would say overall injectable business with new drug delivery system like dual chamber bags or pre-filled syringes or even dual chamber syringes, will keep on going up and which will be the core competency for us. It's not that we are going away from. Even if an oral vaccine comes or immuno-oncology comes, it's inevitably gonna be an injection or an oral pharmaceutical product, which will be anyway having some form of a lyophilization for bulk sterilization or for bulk lyophilization. Or for that matter, even making it, you know, all these products are heat labile, I mean, they decompose on, you know, exposure to atmospheric humidity. Lyophilization will be the backbone for these technologies also in the future.

Ankit Minocha
Founder, MRLR Capital

Thanks. Very comprehensive, very helpful, and wish you all the best.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Thank you.

Operator

Thank you. Our next question comes from the line of Chetan Phalke with Alpha Invesco. Please go ahead.

Chetan Phalke
Investment analyst, Alpha Invesco.

Good evening, everyone, and thank you for the opportunity. Sir, just wanted to understand regarding our Indore plant. As Roonghta rightly mentioned, I mean, we will achieve 35%-40% capacity utilization in the first year, and then it will gradually go up. When can we reach 70%-80% kind of utilization at our Indore plant after we commence the operation? Once we achieve that kind of utilization, what should be our fair understanding of the gross margin trajectory? I mean, can we expect 55% plus kind of gross margin?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. I think for the margin, I'll try to give my point of view, but again, I'll request Roonghta sir to comment about it after I give you the answer about the capacity. In terms of the capacity in a pessimistic way, I'm saying, let's say everything is against us and everything goes wrong, we still look like a 3- to 4-year window after the first. Let's say in April 2022, the commercialization will happen. I'm looking at least a 3- to 4-year window on the pessimistic thing that it'll go. Let's say a 4-year window for a pessimistic way. In an optimistic way, I can look at, 2.5- to 3-year window of, maybe where for us to reach 70%-80% capacity. Because, there are two things which we have to be ready for.

You know, the Navsari I foresee in the next 1.5 years to have that maturity and that saturation coming in because of the dossiers which we are filing. Of course, in addition to the Indian market, which is also growing at that fast pace. If our regulatory what do you call team and the dossier submission team can catch up, can keep the pace with our production team, then we should be fine in 2.5, 3 years. Or if our regulatory team is way behind or we have some other issue where the inspections can be delayed or something delayed from the government authorities in terms of approvals, then it might be 4 years on the higher side.

Chetan Phalke
Investment analyst, Alpha Invesco.

Okay. The gross margin trajectory, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah. Gross margin, I feel, gross margin. I think we already are at around 52%. Let me not say anything. I think we already have reached around 52% or something. Devkinandan Roongta sir, maybe you can throw some light over that. How do you foresee that going forward?

D.K. Roonghta
CFO, Gufic Biosciences

Sir, yes. Because first year will be because of the validation batch. There will be very high consumption of raw material. First year I can see the gross margin may be in the range of around 55%.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Second year it can be increased to 50% and from third, second year onwards, I think the gross margin will be around 55%. First year it will be gross margin 45% because of the validation batch of the initial product to be consumed. Second year will be average, that is around 50% and third year onwards it will be around 55%.

Chetan Phalke
Investment analyst, Alpha Invesco.

Got it, sir. Thank you very much. My follow-up question is, sir, what are the opportunities that we are seeing in the global CDMO market? Because I think some Q2 Q3 back, we had mentioned that we have signed some 3 contracts.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yes.

Chetan Phalke
Investment analyst, Alpha Invesco.

for contract research and development with a couple of big multinationals and a few and a couple of European companies as well. Just wanted to have your views on that, sir.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah, that is the hope which we have. Because, you know, having 300,000 or 320,000 sq ft single premises of having almost all form of injectables, you know, all the way from, like I mentioned. Again, I'm repeating, but please don't get irritated that from lyophilization to PFS to suspensions to dual chamber to even there might be a provision of, what do you call, ophthalmic line also in phase two if we intend to. It just makes. Of course the capacity. The capacity is huge. With this we'll be the biggest general facility manufacturer in the world of lyophilization, even after, I mean, even above China in one of the plants there. I foresee that CDMO will be an important thing for us.

CMO has been an important thing because we always feel that, it's always better to have, these, big brothers or, you know, the big companies to actually help you to reach that scale, which always takes it forward, and that is a thing which we really believe in. We foresee. Definitely there are opportunities. We're already in discussion for our Indore factory. We are in between the inspections and people's visit to Indore will start from, you know, November, December, January itself, even before going live with commercialization. Because we want them to be part of the regulatory process, we want them to give us ideas that whenever we are doing the final touch-ups of the factory, we are incorporating all their ideas and all their guidance. Then when we.

Tomorrow, let's say even if a market opportunity for U.S. opens up for us, we are equipped to handle their, you know, CMO business or CDMO business.

Chetan Phalke
Investment analyst, Alpha Invesco.

Okay. What's the progress on these 3 contracts that you signed a couple of quarters back, if you can?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

We already have two of them, the dossier and stability phase, we are finishing something. For some products the pre-formulation is done. We are looking at, you know, waiting for the Indore facility because then we have to go for the tech transfer there. That always goes through. Some people, like I said, there might be some contract which might fall off because timelines might go here and there. You know, the U.S. generic market is very aggressive in terms of first launches. Talks are already on. I will say two of them are going very aggressively. One we might put on hold because it depends on the timelines of when will the Indore commercialization happen and is the client happy with the time for the ANDA filing.

Chetan Phalke
Investment analyst, Alpha Invesco.

Okay. Got it, sir. That was very helpful. Thank you very much, Pranav.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Operator

Thank you. Our next question comes from the line of Irshan with Vivek Commercial. Please go ahead.

Speaker 13

Good evening. I just had one question, regarding your Aesthaderm division. What is the revenue contribution from this division, and what kind of growth are we seeing in this division from the past Q3,Q4 ?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

The contribution will not be more than, I think, 3% or something. Around 3% if I'm not mistaken. Again, I'll ask Devkinandan Roonghta sir to confirm that. The growth is almost around, since the base is too small, I believe at Aesthaderm, the cosmetic products are not growing much, maybe only around 6%-7%, but the Stunnox, a botulinum toxin, is on a quarter-to-quarter level growing at around at least, maybe I think nearly 53%, I guess.

Speaker 13

What kind of aspirations do we have for this division? Like, what kind of revenue contribution do we aspire to derive from this division, let's say, in the next 3-4 years?

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Specifically for Botulinum toxin, I have mentioned it in the past also that keeping the international market and the potential what it has, India is very, I would say in an infancy stage in terms of penetration. I think I mentioned in the past also, but if you put a gun on my head, I still feel the Botulinum toxin market should be close to, you know, INR 70-80 crore in the next three years, if I can. The potential is much higher in India, but I know the hard work which has to follow. Even if I can do INR 70-80 crore, then the next INR 100 crore and 200, 300 and 500 would be easy.

The first 70-80 will be a big challenge for me.

Speaker 13

Thank you. Thank you. That's it from my end.

Pranav J. Choksi
Chief Executive Officer and Whole Time Director, Gufic Biosciences

Yeah.

Operator

Thank you. Ladies and gentlemen, due to time constraint, that was the last question for today. Now I would like to hand the conference over to Miss Ami for closing remarks.

Ami Shah
Company Secretary, Gufic Biosciences Limited

Thank you. Thank you everyone for joining this call. I hope all your questions and queries are satisfactorily answered by us. In case if there are any further questions that have remained unanswered today, you can reach out to us or Mr. Daven Bhruwa from SDA Investor Relations Partner. The contact details are already provided on the last slide of the presentation uploaded on the website of the stock exchange, and you can find it on the website of the company as well. Thank you so much. Good evening. Stay safe and take care.

Operator

Thank you. On behalf of Gufic Biosciences Limited, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.

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