Ladies and gentlemen, good day, and welcome to the Ipca Laboratories Q1 FY 2027 earnings conference call. As a reminder, all participant lines will be in the listen-only mode, and there will be an opportunity for you to ask questions after the presentation concludes. Should you need assistance during the conference call, please signal an operator by pressing star then zero on your touchtone phone. Please note that this conference is being recorded. I now hand the conference over to Mr. Nitin Agarwal from DAM Capital. Thank you, and over to you, sir.
Hi. Thank you. Hi, good afternoon, everyone, and a very warm welcome to Ipca Labs Q1 FY 2027 earnings call hosted by DAM Capital Advisors Limited. On the call today we have representing Ipca Labs management, Mr. A.K. Jain, Managing Director, and Mr. Harish Kamath, Corporate Counsel and Company Secretary. I will hand over the call to Mr. Jain to make opening comments, and then we will open the floor for questions. Please go ahead, sir.
Thank you, Nitin, and DAM Capital for organizing this call. Today's earnings call and discussion and answer given may include some forward-looking statement based on our current business expectation. This must be viewed in conjunction with risks that pharmaceutical business faces. Our actual future financial performance may differ from what is projected and perceived. You might use your own judgment on information given during the call. Our domestic formulation business for Q1 FY 2027 has delivered growth of 13% to around INR 1,082 crores as against INR 961 crores in Q1 FY 2026. Mid-June 2026, Ipca's rank remained continuously around 16 as per IQVIA. Market share has marginally improved to around 2.08% as against 2.07% in mid-March 2026. Top six brands of Ipca continue to feature in the top 300 brands of the country. In both on chronic and acute segments, Ipca has outperformed the IPM.
Our chronic segment growth is around 17.2%, and acute growth is around 8.9%, and overall, IQVIA has tracked our growth at around 11.7%. Overall export business has delivered growth of around 34% for Q1 FY 2027 to around INR 603 crores from INR 450 crores in Q1 FY 2026. Promotional branded markets of ROW markets has delivered growth of around 16% to INR 143 crores from INR 124 crores in first quarter last financial year. Generic business excluding tender business has delivered growth of around 27% for Q1 FY 2027 to around INR 340 crores as against INR 268 crores in Q1 FY 2026. Institutional generic business has delivered growth of around 107% to around INR 111.75 crores from INR 58 crores in Q1 FY 2026. Approximately INR 40 crores worth of shipment, which was to go in March, was shipped in April, and therefore institutional business has shown exceptional growth in this particular quarter.
API business of Q1 FY 2026 has delivered growth of almost 30% to around INR 424 crores as against INR 362 crores in FY 2026. Almost all businesses has delivered good growth for the company for the first quarter of the current financial year. On consolidation basis, if we see, overall business has grown to around 21% to INR 2,788 crores from INR 2,309 crores in FY 2026. For Q1 FY 2027, we have seen a lot of uncertainties, significant fluctuations in material prices, shipment delays, non-availability of containers, and significant increase in logistic cost, which is further going up from July to August and some of the destination sites like South America and all, very difficult to get the containers and ship. Overall, despite all these factors, we could deliver the better profitability. Overall consolidated EBITDA margins has improved to 22.88% for Q1 FY 2027, from 18.39% for Q1 FY 2026.
That's an improvement of almost 4.49%. The absolute amount is around INR 638 crores as against INR 425 crores in last financial year, an increase of almost 50%. Standalone EBITDA margins for Ipca has improved to 26% in Q1 FY 2027 to around 23.82% from INR 557 crores from INR 416 crore in last financial year, an improvement of almost 34%. Having given the broad numbers, now I'll request participants to ask questions.
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 touchtone telephone. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use answers while asking questions. Ladies and gentlemen, we will wait for a moment while the question queue assembles. Participants who wishes to ask a question may press star and one now. Participants who wish to ask a question may press star and one on their touch-tone telephone. The first question is from the line of Rashmi Shetty from Dolat Capital. Please proceed.
Yeah. Thanks for the opportunity. Just on the India part, in the acute segment, we have underperformed the market. What are the reasons for it? How we are doing overall, in the India business, both in the chronic as well as in the acute segment? What is the outlook for India business for FY 2027?
Both on chronic and acute, we have outperformed the market. It is not that we have underperformed on acute. The market IPM growth was around 4.5%, and IQVIA said our growth was at 8.9%. By and large, in this market, I think our anti-malarial segment has declined by almost around 24% this quarter. That is one of the reason that our performance is not that great compared to the overall scene, because there was malaria in this particular period. As chronic is concerned, our track by IQVIA was around 17.2%, and the market growth was around 15.2%. As far as the overall business growths are concerned, let us say our internal growth, our pain management business which includes rheumatoid arthritis and osteoarthritis, both put together has grown by around 13% for the quarter. Cardiovascular and anti-diabetic segment has grown by around 17%.
As I talked earlier, malaria has declined by almost around 24% in this quarter. Now malaria business is becoming almost insignificant. It is just hardly 1% of our overall business. Antibacterials has delivered growth of 1%. CNS delivered a growth of almost around 19%. Our cough and cold segment has delivered growth of around 9%. Derma business has delivered growth of almost around 17%. Urology business has delivered growth of almost around 25%, ophthalmology around 17%, and overall growth of business is almost around 13% overall. The overall outlook is also looking better because the market growth itself has started moving up, and what we are seeing the trend that the chronic business growth rate in the market is very good, and we are also delivering growth in line with markets now.
The guidance which you have given earlier of 12%-13% will remain for this year, right?
Yeah.
Okay. Sir, in terms of institutional business, what kind of normalized growth should we see in the subsequent quarters? Or it is best if you can give for the entire year only, and where the pickup is happening, basically.
Let's say, as I said, in this quarter, the growth has been significant is only because of 40 crore worth of shipment, which was to go in March. They were shipped in April because of shipping delays and all those. They are all nominated shipments, and it is not in our hand. We just deliver the goods to the notify that goods are available to the nominee of the buyer, and they pick up the goods depending on the availability of shipment. What happens sometime is, by the time they book the ship and they take the permission to ship, the freight rate and all that, the ship has gone or the rate has gone up. So again, he has to start, and then delivery become later. Because of that reason, the shipments were delayed, and therefore there is exceptional growth.
Institutional business, we don't look for a very high growth. It will remain in single digit kind of growth. Overall business may be around INR 260 crore to INR 300 crore. That's the range it will be. We are not looking for a very high growth from institutions in time to come.
Rashmi, ma'am, you can continue with your question.
Just one last question, if I may. On the generic segment, we have seen a pretty good growth. Earlier we were facing some supply issues in the U.K. business. Whether all those things have been resolved now, and therefore we are seeing a good growth pickup. Are we seeing any traction in other geographies? If you can elaborate on that. What will be the outlook for the whole year for this piece as well as for the branded generic business?
Let's say overall, if you look at generic business broad-based, all the market has given good growth. If you look at the European business overall has delivered almost around 70%, which is EU is the main growth driver. Almost business has become from INR 53 crore to INR 137 crore. That's a significant growth that has come from EU. Our spend to U.S. is around 8% up. Canada, there is some minor decline is there. Overall, let's say the generic business excluding institutions is around INR 268 crore, so it became around INR 370 crore for Ipca as a whole. Overall growth because of institutions and other European high growth in Europe, overall business growth was very high.
Are we going to upgrade our guidance for generic business for FY 2027?
Overall, let's say in the beginning of the year, we had given the business growth guidelines that overall business will grow around 12%-13%. But now looking at the upside, what we are getting from the overall generic business, India business performing very well. Even the API business has given good growth. So overall growth percentage from 12% to 13% may become almost around 14% to 16% overall for the whole of the current financial year.
Okay. This 14% to 16% will be mainly driven from your upgrading in some part of the guidance in branded market, generic market. Any update on your Unichem Laboratories? That is also performing very well in terms of the margin also and in terms of a strong growth on revenue front. Where do we stand there and what kind of growth and margin guidance do we give now?
Overall for Unichem, I think if you look at for first quarter, U.S. business has given growth of almost around 27%. That is largely, I think Unichem portfolio per se has grown by around 9%. So it is Ipca portfolio which they are selling for us in U.S. That portfolio has grown very well and that's the reason it delivered almost around 27%. Per se, Unichem's own portfolio has delivered a growth of almost around 9%.
Okay.
Their Europe portfolio has delivered growth of almost around 3%. Brazil has given good growth, and Brazil traction is also improving. So they have grown by almost around 52% in this quarter and they will continue to do well in Brazil. Acacia business which is their ROW market business, that has also become almost around double in the quarter from INR 8 crore to INR 17 crore. API business of Unichem has also started now moving up from INR 33, INR 34 crore to almost around INR 58 crore. So it's almost around 73% kind of overall improvement in that business. So overall, Unichem has also done well in terms of overall growth. Yeah.
The guidance of 10% growth in the Unichem portfolio and 13% EBITDA margin, which you had given last quarter, that remain intact, right?
Yeah. Unichem guidelines, I am not revising right now. So let's see for some more quarter how it performs and we are working hard to deliver more growth, but let us see on ground and thereafter we will revise the guidelines.
Okay. Thank you so much, sir, from my side. That is it.
Thank you. The next question is from the line of Kunal from Axis Capital. Please proceed.
Hi, good afternoon. Thanks for the opportunity. Sir, firstly, on the U.S. business, if you mind giving us some color on what we can expect for the next one to two years. Maybe some sense of the number of launches, both from Ipca stable as well as from Unichem. Also you had talked of in the past that some of Unichem's products, you are going to change the API source to Ipca. So some more color on the U.S. business would be very helpful, sir.
I say normal Ipca launches will be almost around three to four products and Unichem will also launch similar kind of products. So almost in a year, I think there will be around seven to eight kind of launches, both Ipca and Unichem put together will be there. Some of the product approvals are already received for source changes. Some products are still in pipeline. So that journey is going on. They are also working very hard on, let us say, cost reductions on API, and those are also filed with FDA and somewhere it is on CB30 and somewhere it is on the fast basis, so it may take some more time to get those kind of approvals, but that journey is going on. Yeah.
But sir, on your base then, can we expect a 20%, 30% kind of a consistent growth for the next few years?
It's maybe around 15%, 16%, 17% kind of growth is possible, but currently looking at portfolio and other things.
Sure, sir. One more question, sir. You mentioned about material costs going up significantly. So maybe if you can just quantify a bit on the kind of gross margin impact that one can expect in the coming quarters. Is this fluctuating or is it going up unidirectionally? Some more color, sir, would be helpful.
Gone up, then came little down, then again little because petroleum prices going up, somewhere supply chain disturbances, some product going down, somewhere going up. Overall, if you look at last financial year, let's say we have grown in terms of turnover, but it caused overall, let's say, material cost to sales was down by around 2%. This quarter, when you look at, we have grown by around 21%, and my material cost has also moved up by 21%. So overall, let's say we have improved the EBITDA margin by almost around 2.4%, but largely it has not come from overall, let's say, savings on material cost. Savings on material cost is just 0.14%.
Largely, the EBITDA improvement has come because turnover has moved up, so personal cost to sales has gone down by almost 1.41%, and overall manufacturing cost to sales overall to the revenue has gone down by almost 0.91%. On consolidation basis, if you look at material cost is down by almost 1.35%. Personal cost is down by almost 1.95%. Manufacturing and other cost is down by around 1.19%. So, overall, let's say EBITDA has improved on consolidation basis almost 4.49% for the quarter.
But sir, my question is more like going forward because you said in July, August, prices are going up again. So do you foresee some margin pressures in the rest of the quarters?
No. No margin pressure. I would see that compared to sales group, material cost will little come down.
Okay. That is good to know. And sir, any other cost, you also mentioned shipping and container and logistics cost, so all that is baked in your guidance, sir, right?
Yeah, we have taken that into account, but you see, freight rate somewhere has gone up by three times. Like, say, South American markets from, I think, containers, the freight was almost around 3,000. It is almost around 9,000- 10,000. That too, availability is difficult. As far as U.S., reefer containers were available at around 7,000 -7,500. Now it is almost 12,500- 3,000. Even European containers, which were 3,000, now it is almost around 5,500. So everywhere rates are moving up.
Got it.
Shipment and we have taken that into account, yeah.
Got it, sir. Just one more question if I can. Sir, on the India business, can you share a sales force strength and what are the expansion plans?
We are almost around 7,000 people, medical reps around, and expansion plan is already completed. So that 7,000 includes that. I think in the mid of the year, we may include another almost around 200 people more on some of the new divisions which we will be launching in the current year. But that will not increase significantly the number, just by around 200.
Got it, sir. Very helpful, sir. Thank you, and all the best.
Thank you. The next question is on the line of Mohit from Oculus Capital. Please proceed. Mr. Mohit?
Hello.
Yes, sir.
Yeah. Sir, my question is regarding your associate company, Lyka Labs. We invested in this company in FY 2022, and then invested through primary route also till FY 2025. Now this company's revenue has not grown and even the EBITDA has become negative. So any plans to revive this company? What is happening there in the lyophilized injection? What are we doing there?
Let's say they are building up three different kind of businesses. One is for animal health business. They have lot of injectables which goes in animal health. They have done good work in terms of building that business. Second, they have started the critical care business in terms of directly selling to the hospitals and all. Earlier, their most of the business was coming on from B2B supplies to the other pharma company. That business is coming down and their own promoted business is now moving up. That is the second business and third, they have a lot of products relating to IVF. That part has also started doing well and they have added almost around significant number of field force in last two years, and that is they are incurring the cost.
Some of these are around breakeven and some of these divisions is still under below breakeven. Therefore, that cost is also with a part of their overall. Overall, I think we are hopeful that Lyka will do well in time to come. They are on the right path.
Okay. Sir, just one suggestion. At the time of the results, if you guys can give some press release mentioning what is happening there, because it is very difficult to find out what that company is doing because that is also a listed company. If a press release can be given with the updates, what is happening there, that will be very helpful. Thank you, sir. All the best.
I think this year they have given the press release.
Okay. I could not see that. Okay. Thank you.
Okay, we will send it to you, yeah.
Thank you. The next question is from the line of Shilpa from Lotus Wealth. Please proceed.
Hello. My question is in regards with Unichem. Sir, our gross margin improvements are due to rupee depreciation driving realization or supply of API from Ipca has started?
Ipca supply to Unichem is hardly any. I think one product they have given the order now, because that's a source change has happened. One is their overall cost reductions has been good as far as their own captive production of API. That has also resulted in overall some margin improvement there.
Okay.
Their European business is doing well. That business improvement overall in the margins and Brazil which were incurring losses now is coming positive and that business is also expected to improve well. These are the things which are resulting in the better overall margin. As they start, they have whole program of filing new products in all these markets like Europe, Australia, New Zealand, Canada, Chile and all those. I think these all when these registrations start coming in, the business profile of this company will also change. Because currently it's mostly the U.S. and the market where the margins are always under pressure. These markets, once the product mix, overall market mix improve, profitability of Unichem will also improve.
Okay, sir. In this quarter, rupee depreciation impact is not as such, right?
Rupee depreciation is also there. If you look at overall turnover, let's say out of 21% growth, 5% increase is only on account of rupee depreciation. Because dollar has almost gone up by almost around 11% compared to last year's first quarter. That has also resulted simultaneously that our material cost has also moved up. But that has helped in the overall margin. Material cost has also moved up because let's say a lot of your contents are also in dollar terms, and those costs have also moved up.
Okay.
That is only for the net 25%, because material cost to sales is almost around 25%. So on 25% of that cost, your depreciation cost has gone, but rest has come in terms of margin.
Okay, sir. Thank you.
Thank you. Before we take the next question, we would like to remind participants that you may press star and one to ask the question. The next question is from the line of Tushar from Motilal Oswal. Please proceed.
Thanks for the opportunity. Sir, I missed the EBITDA margin guidance, if you have shared for FY 2027, firstly. If you can just share again.
At the beginning of the year, we gave the EBITDA margin guidelines of around 22% on consolidated basis. I think because of better performance, overall EBITDA margins may remain around 23%. I am improving the guidelines by 1%, yeah.
Okay. Sir, secondly, while the raw material fluctuations are there, but the rupee depreciation should be able to offset any fluctuation in your raw material prices. In fact, is it safe to assume that rupee depreciation benefit is much more than the raw material price fluctuation and hence it should result in better gross margin?
Let's say material cost to sales is 25%. Out of that also there are a lot of your Indian ingredients and other ingredients which are imported one. There are a lot of other costs which is also related to your dollar terms. Let's say freights are in dollar terms. Your lot of testing materials and lot of those things are in dollar terms. There are a lot of machine parts which are of imported machines and testing equipments and all are also relating to dollar terms, so their maintenance contracts and other things are also linked that way. We have huge amount of field force in international markets. So their salaries are also going in dollar terms because of promotional markets and all kind of things. It's not only that raw materials are impacted, it's other things are also getting impacted.
For promotional market, we are running lot of non-trading offices in various international markets. So cost of that is also going up because of USD. In spite of, let's say, the increase in the cost and all, overall because of depreciation, to the extent of your margins and some of the Indian cost, that cost is not moving up and therefore you are seeing that there is a significant improvements in your overall manufacturing and other expenses.
Got it.
Sales has moved up, but that cost has come down.
Got it. And sir, what is driving growth in Europe segment itself? Is it new product launches? Is it market share gain?
New product launches are also there. Both European, U.K. and European business, both have done very well.
Has the funnel from Unichem's portfolio started reflecting in the Europe business for Ipca?
No.
When do we think that would start happening, sir?
It will take some time because they have started filing in those markets. We have yet to get the approvals and it takes almost around one and a half year after the filing for approvals to come. Yes, there is a significant amount of programs for filing in the various markets for them. Once those approvals start coming in, the margin profile for Unichem will also start changing.
Understood, sir. Lastly, when do we intend to start new filings for U.S. market, apart from product transfers?
No, we are already doing that. I think four to five filings will happen every year for Ipca.
Got it. Thanks a lot. That's it from me.
Thank you. The next question is on the line of Kartick Bane from Bajaj Life. Please proceed.
Thank you for the opportunity. With the Indian field force expansion largely complete and the profitability is also improving, would incremental cash flows be deployed towards acquisition or any capacity expansion, or would focus more on filings and launches?
The capacity expansion will also be needed, and that's going on right now because we will need a lot of capacity for European markets and U.S. market. Right now we are building up capacities for all these controlled releases and all the extended release kind of formulations at our Silvassa. Traditional CapExs are going on. Biotech is one area where also CapExs are going on in terms of further increasing R&D investments, R&D assets and at plant level, also those kind of CapEx are there. On API side also, we are building up new plants because we are running out of capacities at Ratlam. New plants are built up at Dewas site and also at Wardha for intermediates and all. Some of the investments are also going on for converting the existing intermediates into more for continuous process kind of processes. Those investments are also there.
Largely, I think, almost around INR 700 crore to INR 800 crore in current year will go in the CapEx side itself. Yeah.
Thank you.
Thank you. The next question is on the line of Aditya Chheda from InCred Asset Management. Please proceed.
Hi, this is Pooja Sanghi. Thank you for the opportunity. We understand that the prices were contracted earlier and now the rupee has depreciated, so your realizations would have gone up in rupee terms. But as per my understanding of the past, whenever this kind of thing happens, the dollar prices again get renegotiated lower. If that were to happen, sir, how long do you feel that the currency benefit and the higher gross margin will be reflected in our statements like another two quarters or another year?
I think there are no such renegotiations of the prices where the prices are to be reduced. No. Rather, we are increasing the prices everywhere because your costs are also moving up. All other costs are also moving up. There are no reductions and prices are by and large, increasing only, not going down.
Okay. Thanks, sir.
Thank you. Participant who wishes to ask a question, please press star and 1 now. Participant who wishes to ask a question, please press star and 1 now. The next question is a follow-up question from the line of Kartick Bane from Bajaj Life. Please proceed.
Hello. Thank you for the opportunity again. Could I get a split between the domestic growth as price volume and the new product launches?
Overall, I think volume growth is almost around 5%. Price growth is almost around another, I think 4.5%-5%, and new product launches may be around 2% or so. So overall growth is around 13%. Yeah.
Thank you.
Compared to industry, our volume growth is higher.
Thank you. The next question is on the line of Rashmi Shetty from Dolat Capital. Please proceed.
Yeah, thanks for the opportunity again. Just one bookkeeping question. This quarter, we have seen a decline in the interest cost quarter-on-quarter. If you can just give some thoughts on the total gross debt number and whether we have done any repayments or anything.
Last financial year, we had almost around close to $50 million as dollar loans, which we have completely repaid before March itself. In fact, before this dollar depreciation started, we have almost prepaid every dollar loan. We don't have those kind of debt in books. Currently, the debt may be around INR 193 crore in books. That's the long-term debt. We have zero working capital debt. I think by this year-end, what we will have is INR 70 crore of term loan debt outstanding, and that will be repaid completely in the next financial year. So practically, we have more cash in books compared to the overall loans. So loans are hardly around INR 193 crore currently.
Out of that INR 193 crore, you are saying you will be making a repayment of INR 70 crore also.
No. At the year-end, INR 70 crore will be balanced, because that loan is at much cheaper rate than current market rates.
Okay.
I earn more in mutual fund rather than. Why should I pay it? I will pay on due date. Yeah.
Okay. We do not have any short-term borrowings.
Zero. Yeah.
Okay. Interest cost is expected to decline in the subsequent quarters also, right?
Yeah. Interest cost will be hardly any. We will be earning more than decline.
Okay. Yeah. Understood, sir. Thank you. That is it from myself. Okay.
Thank you. Next question is on the line of Ankeet Pandya from Baroda BNP. Please proceed.
Yeah, hi. Thank you for the opportunity. Just one question. Can you give some guidance on FY28 numbers in terms of the top line growth and EBITDA margin?
I think for the current financial year, we have already given the guidelines. Revised guidelines is around 14%-16% kind of growth. We have revised it from 12%-13% earlier. And EBITDA margin consolidated from 22%-23%. We have revised upward by 1% overall.
Sir, I am asking for FY28.
So 2028 guidelines, we will give at the time of quarter 4.
Okay, fair enough. All right. Okay. That is it from my side. Thank you.
Thank you. Participant who wishes to ask a question, please press star and one now. Participant who wishes to ask a question, please press star and one now. The next question is from the line of Saion Mukherjee from Nomura. Please proceed.
Yeah, good evening. Thanks for taking my question. Just one question on EBITDA margin for your consolidated business and for Unichem Laboratories. If you sort of bake in all the impact of Unichem Laboratories synergies playing out over the next, say, 3 years or so, and business scaling up in U.S. and other markets, and India growing, where do you see EBITDA margin settling from a slightly medium to longer term perspective for both Unichem Laboratories and Ipca Laboratories as a whole?
If Ipca margin, which is maybe around 26%, could go up to almost around 30% kind of margin is possible. Overall EBITDA margins maybe two, three years down the line, maybe around 25%-26% overall for consolidated basis, because by the time all these other subsidiary companies will also start doing very well.
All right. Sir, in terms of key investments, what are those investments or new initiatives, let's say, which Ipca is planning to undertake over the next two, three years? If there are any plans or thought of inorganic, organic moves, some big investment plans.
Right now, our investment is by and large more is happening in biotech side. We have almost around now seven candidates in pipeline. We are working on more number of now. R&D has capacity to work on at least around three to four products now every year. I think two products now we have already taken these engineering batches, and results are absolutely in line with what we were expecting. I think validations are going on, and a lot of investment will happen in terms of clinical trials of all these biosimilars. We are targeting all global markets, and most of the products are known titer values are practically double or more of the current known in the market side. We expect to do well, and there will be good amount of investment further will be happening in biotech.
Current year also we will be investing almost around INR 100 crore more on building up the piloting facilities and additional R&D investment in biotech. A lot of those investments are happening now. Maybe I think in one or two years' time, we may need to further increase our capacities what we have built up on biotech. That will be another additional investment in time to come will happen.
So sir, the EBITDA guidance or EBITDA expectation that you have, you are factoring in these clinical trials and these investments on
Yeah
biotech.
That we are factoring. Because next two years, no revenue will come.
Because by the time clinical trial completes, so all those we are factoring in.
Right. And sir, is it possible to give some color on these products? So, it seems that you are mentioning that your yields are much better than what is available in the market today. So these seven biosimilars and two of them which are probably little advanced, are these old products or are these products which will go off patent and you will be there in the first wave in the market? And if you will give some color on some idea about what kind of products are you working on.
By and large, these are old products, but there is one product which is maybe that we are targeting around patent expiry itself, and that is very large product. Mostly the other products are all are patent-expired products.
Right. You are saying in 2 years we will start to see, that means FY29, FY30 revenues will start to flow in from biosimilars.
Yeah. Because first we have to produce your API, then formulations, validate formulations, do the stability, then go for clinical trials. That process is all going on simultaneously, yeah.
Okay. These are like global trials, so you will sort of file in U.S., Europe, and out of the markets all?
Yeah, put together, these are global trials. We already consulted European authorities, U.K., then also U.S. for all the clinical trials protocols and all. All protocols are in line with all these regulatory agencies.
Therefore the filing will happen next year, is it? If you have to launch in fiscal 2030, in fiscal 2028, you will be making your first filing. Will that be a right assessment?
I think this year practically your first is validations of those products will happen, and thereafter formulations, the development and stability charging will happen in this year. Somewhere I think mid of next year, the initial stability results will come and thereafter by the time we have already taken those kind of approvals, so we will start the clinical work. Now clinical work is significantly reduced. We are also the waiver of phase III from European authorities and also from U.S. So it is only the
initial work need to be done. The cost has also come down significantly now because RLD is not required for phase III. So RLD cost becomes very high. Those exemptions have already come. Looking into biosimilarities and other parameters and results, what we have submitted to the various regulatory agencies. So overall, I think clinical things will start happening from the next financial year.
Right. Okay, sir. Thank you.
Thank you. Yeah.
Thank you. That was the last question for today. I now hand the conference over to the management for the closing comments. Over to you, sir.
Yeah. Thank you very much all the participants. Thank you. We can close this call, madam.
Yes, sir. On behalf of DAM Capital, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.