Ipca Laboratories Limited (IPCALAB) Earnings Call Transcript & Summary

August 14, 2026

NSEI IN Health Care Pharmaceuticals earnings 47 min

Earnings Call Speaker Segments

Operator

operator
#1

Ladies and gentlemen, good day, and welcome to the Ipca Laboratories Q1 FY '27 Earnings Conference Call. 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.

Nitin Agarwal

analyst
#2

Thank you. Good afternoon, everyone, and a very warm welcome to Ipca Labs Q1 F '27 Earnings Call hosted by DAM Capital Advisors Limited. On the call today, we have representing Ipca Lab 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'll open the floor for questions. Please. Thank you.

Ajit Kumar Jain

executive
#3

And DAM Capital for organizing this call. Today's hearing call and discussion and answer given may include some forward-looking statements based on our current business expectations. 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 may use your own judgment on information given during the call. Our domestic formulation business for Q1 FY '27 has delivered growth of 13% to around INR 1,082 crores as against INR 961 crores in Q1 FY '26. June '26, Ipca's rank remained continuously around 16% as per IQVIA. Market share has marginally improved to around 2.08% as against 2.07% in March '26. Top 6 brands of IPCA continue to feature in the top 300 brands of the country. And both on chronic and acute segments, ICA 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. Overall export business has delivered growth of around 34% for Q1 FY '27 to around INR 603 crores from INR 450 crores in Q1 FY '26. 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 '27 to around INR 340 crores as against INR 268 crores in Q1 '26. Institutional generic business has delivered growth of around 10% to around INR 11.75 crores from INR 58 crores in Q1 FY '26. 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 '26 has delivered growth of almost around 30% to around INR 424 crores as against INR 362 crores in FY '26. So almost all businesses has delivered good growth for the company for the first quarter of the current financial year. On a consolidation basis, if you see overall business has grown to around 21% to INR 2,788 crores from INR 2,309 crores in FY '26. Q1 FY '27, we have seen a lot of uncertainties, significant fluctuations in material prices, shipment delays, nonavailability of containers and significant increase in logistic costs, which is further going up in the month of -- from July to August and some of the destination sites like South America and all very difficult to get the containers and ships. Overall, despite all these factors, we could deliver better profitability. Overall consolidated EBITDA margins has improved to 22.8% for Q1 FY '27 from 18.39% for Q1 FY '26. That's an improvement of almost around 4.9% from absolute amount is around INR 638 crores as against INR 425 crores in last financial year, an increase of almost around 50%. And stand-alone EBITDA margins for I has improved to 26% in Q1 FY '27 to around 2.82% from around INR 557 crores from INR 416 crores in last financial year, an improvement of almost around 34%. Having given the broad numbers, now I'll request participants to ask.

Operator

operator
#4

The segment, we have the [indiscernible].

Ajit Kumar Jain

executive
#5

Ipca, our growth at 8.9%. But by and large, in this market, I think our antimalarial segment has declined by almost around 24% this quarter. And that's one of the reason that our performance is not that great compared to the overall because malaria in this particular period. chronic is concerned, our trend by IQVA around 17.2% and chronic growth was almost around -- the market growth was around 15.2%. As far as the overall business growth are concerned, 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 antidiabetic segment has grown by around 17%. As I talked earlier, malaria has declined by almost around 24% in this quarter. And now malaria business is becoming almost insignificant. It is just hardly 1% of our overall business. [ Endobacterial ] has delivered growth of 1%. CN has delivered a growth of almost around 19%. Our cough and cold segment has delivered growth of around 9%. Dermatology has delivered growth of -- 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% over -- and 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 in the market is very good, and we are also delivering growth in terms -- in line with markets now.

Unknown Analyst

analyst
#6

So the guidance which you have given earlier of 12% to 13% will remain for this year, right?

Ajit Kumar Jain

executive
#7

Yes, yes.

Unknown Analyst

analyst
#8

Okay. And sir, in terms of institutional business, what kind of normalized growth should we see in the subsequent quarters? Or is best if you can give for the entire year only and where the pickup is happening basically.

Ajit Kumar Jain

executive
#9

Let's say, as I said in this quarter, the growth has been significant is only because of INR 40 crores 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 to -- we just deliver the goods to notify that goods are available to the nominee of the buyer, and they pick up the goods depending on the availability of shipment. And what happens sometimes 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 do start and then delivery become later. So because of that reason, the shipments are delayed, and therefore, there is exceptional. Institutional business, we don't look for a very high growth. It will be -- remain in single-digit kind of growth from the -- and overall business may be around INR 260 crores to INR 300 crores. That's the range it will be. We are not looking for a very high growth from institutions and

Unknown Analyst

analyst
#10

Just one last question, if I may. On the generic segment, we have seen a pretty good growth. So 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?

Ajit Kumar Jain

executive
#11

Overall, if you look at broad all the market has given good growth in the -- if you look at U.K. European business overall, that has delivered almost around 70%, which is the main growth driver. Almost business has become from INR 33 crores to INR 137 crores. So that is a significant growth has come from EU. U.S. has given around -- our to U.S. is around 8% up. Canada, there is some minor decline is there. And overall let's say, the generic business is almost around -- excluding institution is around INR 268 crores, it became around INR 370 crores for ICA as a whole. And overall growth because of institutions and other European high growth in Europe, overall business growth was very high.

Unknown Analyst

analyst
#12

So are we going to upgrade our guidance for the generic business for FY.

Ajit Kumar Jain

executive
#13

The overall business will grow around 12% to 13%. But now looking at the upside what we are getting from the overall generic business, India business performing very well 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.

Unknown Analyst

analyst
#14

Okay. And this 14% to 16% will be mainly driven from your upgrading in some part of the guidance in branded, generic market? And any update on your UniChem is also performing very well in terms of the margin in terms of strong growth on revenue front -- where do we stand there? And what kind of growth and margin guidance we.

Ajit Kumar Jain

executive
#15

For UniChem, I think if you look at first quarter, U.S. business has given growth of almost around 27%. And that is largely -- I think UniChem portfolio per se has grown by around 9% I 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 37%, the UniChem's own portfolio has delivered a growth of almost around 9%. Then 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 continue to do well in business, which is the ROW market business, that has also become almost around double in the quarter from INR 8 crores to INR 17 crores. So overall -- and API business of UniChem has also started now moving up from INR 33 crores, INR 34 crores to almost around INR 58 crores. So almost around 73% kind of overall improvement in that business. So overall, UniChem has also done well in terms of overall.

Unknown Analyst

analyst
#16

And the guidance of 10% growth in the UniChem portfolio and 13% EBITDA margin, which you had given last quarter, that remains intact, right?

Ajit Kumar Jain

executive
#17

UniChem guidance, I'm not revising right now. Let's see for some more quarters how it performs and we are working hard to deliver more growth, but let us see on ground and thereafter, we'll revise the.

Operator

operator
#18

The next question is from the line of Kunal from Axis Capital.

Kunal Randeria

analyst
#19

Sir, firstly, on the U.S. business, if you mind giving us some color on what we can expect for the next 1 to 2 years, maybe some sense of the number of launches, both from ICA as well as from UniChem. And also you had talked in the past that some of UniChem products, you are going to change the APIs to ICA. So some more color on the U.S. business would be very helpful, sir.

Ajit Kumar Jain

executive
#20

S normal ICA launches will be almost around 3 to 4 products and UniChem will also launch similar kind of products almost in a year where I think there will be around 7 to 8 kind of launches, both I and UniChem put together will be there. And 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's say, cost reductions on API and those are also filed with the FDA and somewhere it's on CD30 and somewhere on the past basis. So it may take some more time to get those kind of approvals, but that journey is going on, yes.

Kunal Randeria

analyst
#21

But on your base, then would it be kind of -- can you expect a 20%, 30% kind of a consistent growth for the next few years?

Ajit Kumar Jain

executive
#22

It maybe around 15%, 16%, 17% kind of growth is possible, but currently looking at portfolio.

Kunal Randeria

analyst
#23

Sure, sir, 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? And is this, I mean, fluctuating or is it going up directionally? Some more color, sir, would be helpful.

Ajit Kumar Jain

executive
#24

Gone up, then came a little down, then again, a little because of 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 I 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, material cost savings on material cost. It is just savings on material cost is 0.14%. Largely, the EBITDA improvement has come. The turnover has moved up, so personnel cost to sales has gone down by almost around 1.41% and overall manufacturing cost to sales overall to the revenue has gone down by almost around 0.91%. And on consolidated basis, if you look at material cost is down by almost around 1.35% Personnel cost is down by almost around 1.5% manufacturing and other cost is down by around 19%. So overall, let's say, EBITDA has improved on a consolidation basis almost a 4.49% for the quarter.

Kunal Randeria

analyst
#25

But sir, my question is more like going forward because you said in July, August prices are going up again. So do you foresee the margin pressure in the rest of the quarter?

Ajit Kumar Jain

executive
#26

No, no. No margin pressure. I would see that your sales -- compared to sales growth, material cost will come down.

Kunal Randeria

analyst
#27

Okay. That is good to know. And sir, any other cost, you also mentioned shipping and container and logistics costs. So all that is baked in your guidance, right?

Ajit Kumar Jain

executive
#28

Yes, we have taken that into account, but you say freight rate somewhere has gone up by 3x. Like say, South American market from I think containers freight was almost around 3,000 is almost around 9,000 to 10,000. And that too availability is difficult. As far as U.S. shipper containers were available at around 7,000 to 7,500. Now it is almost 12,500 to 13,000. Even European containers, which was 3,000 now is almost around 5,500. So everywhere rates are moving up.

Nitin Agarwal

analyst
#29

Taken into account.

Kunal Randeria

analyst
#30

Got it, sir. And just one more question, if I can. Sir, on the India business, can you share the sales force and what are the expansion.

Nitin Agarwal

analyst
#31

We are almost around 7,000 people, medical reps around and expansion plan is already completed. So that 7,000. I think in the mid of the year, we may include around almost around 200 people more in some of the new divisions, which we'll be launching in the current year. But that will not increase significantly the number, just around.

Operator

operator
#32

The next question is from the line of Mohit from Oculus Capital.

Mohit Ralhan

analyst
#33

Sir, my question is regarding your associate company, Lyka Labs. We invested in this company in FY 2022 and then invested through primary also until FY '25. Now this company's revenue has not grown and even the EBITDA has become negative. So any plans to revise this company? What is happening there in the localized injection? What are we doing there?

Nitin Agarwal

analyst
#34

They are building up 3 different kind of businesses. One is for animal health business. There are a lot of injectables, which goes in animal health. They have done good work in terms of building that business. they have started the critical care business in terms of directly selling to the hospitals and all. Earlier where most of the business was coming on from P2P supplies to the other pharma companies. That business is coming down and their own promoted business is now moving up. So that is the second business. And third, they have a lot of products relating to IVF. So that part has also started doing well, and they have added almost around significant number of field force in the last 2 years. And that is they are incurring the cost. Some of these are around breakeven and some of these divisions is still below breakeven. And therefore, that cost is also a part of their overall. So overall, I think we are hopeful that Lyka will do well in time to come.

Ajit Kumar Jain

executive
#35

They are on the right.

Mohit Ralhan

analyst
#36

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 that is also a listed company. So if a press release can be given with the update what is happening there that will be very helpful.

Unknown Executive

executive
#37

I think this year, we have given the press release

Operator

operator
#38

The next question is from the line of Shilpa from Wealth.

Unknown Analyst

analyst
#39

My question is in regard realization or supply of API from.

Ajit Kumar Jain

executive
#40

Supply to UniChem is hardly any.

Unknown Executive

executive
#41

Because I think one product they have given the order now because that source change has approved. So there is no -- one is their overall cost reduction has been good as far as their own captive production of A. So that has also resulted in overall some margin improvement there. And also their European business is doing well. So 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. So these are the things which are resulting in the better overall margin. And as they start, they have whole program of filing new products in all these markets like Europe Australia, New Zealand, Canada, and all those. I think these all 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. So these markets, once the product mix -- overall market mix improves, the profitability of UniChem will also improve.

Unknown Analyst

analyst
#42

Okay, sir. So in this quarter, rupee depreciation impact is not as such, right?

Ajit Kumar Jain

executive
#43

Rupee depreciation is also there. If you look at overall turnover, let's say, out of, let's say, 21% growth, 5% increase is only on account of rupee.

Unknown Executive

executive
#44

Rupee depreciation.

Ajit Kumar Jain

executive
#45

Because dollar has almost gone up by almost around 11% compared to last year's first quarter. But that has also resulted simultaneously that our material cost has also moved up. But that is helping in the margin. But material cost has also moved up because that's a lot of your contains are also in dollar terms and those costs has also moved up. But that is only for that 25% because material cost to sales is almost around 25%. So 25% of that cost, your depreciation cost has gone, but the rest has come in terms of.

Operator

operator
#46

The next question is from the line of [indiscernible] from Motilal Oswal.

Unknown Analyst

analyst
#47

Sir, the EBITDA margin guidance for FY '27.

Unknown Executive

executive
#48

At the beginning of the year, we gave the EBITDA margin guidance of around 22% on a consolidated basis. I think because of better performance, overall EBITDA margins may remain around 23%. So I'm improving the guidance by 1%.

Unknown Analyst

analyst
#49

Sir, the raw material fluctuations are the rupee could to offset [indiscernible] depreciation benefit is much more than the raw material price fluctuation and hence, it should result in better gross margin.

Unknown Executive

executive
#50

Material cost to sales is 25%. So out of that also, there are a lot of 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 freight are in dollar terms, a lot of testing materials and a lot of those things are in dollar terms. There are a lot of machine parts, which are of imported machines and testing equipment and all are also relating to dollar terms. So the maintenance contracts and other things are also linked that way. We have a huge amount of sales force in international markets. So their salaries are also going in dollar terms because of promotional markets and all kind of things. So there are -- it's not only the only materials are impacted, it's other things are also getting impacted. promotional markets, we have -- we are running a lot of nontrading offices in various international markets. The cost of that is also going up because of dollar. So it's overall, but yes, in spite of, let's say, increase in the cost and all, overall because of depreciation, it is to the extent of your margins and some of the Indian cost, that cost is not moving up. And therefore, you see that there is a significant improvement in your overall manufacturing and other expenses. sales has moved up, but that cost has come down.

Unknown Analyst

analyst
#51

And what is driving growth in Europe segment? Is it new product launches, market share gain.

Unknown Executive

executive
#52

There are new product launches are also there. But both Europe and U.K. and European business, both have done very well.

Unknown Analyst

analyst
#53

And has the funnel from UniChem portfolio started reflecting in the Europe business for IA?

Unknown Executive

executive
#54

No, no.

Unknown Analyst

analyst
#55

When do we think that will start happening, sir?

Unknown Executive

executive
#56

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 1.5 years after the filing for approvals to come. But yes, there is a significant amount of programs for filing in the various markets. So once those approvals start coming in, the margin profile for UniChem will also start

Unknown Analyst

analyst
#57

And when do we intend to start new filings for U.S. market apart from product.

Unknown Executive

executive
#58

We are already doing that. I think 4 to 5 filings will happen every year.

Operator

operator
#59

The next question is from the line of Karthik from Bajaj Life.

Kunal Randeria

analyst
#60

With the Indian field force expansion largely complete and the profitability also improving, would incremental cash flows be deployed towards acquisition or any capacity expansion or focus more on filings and launches.

Ajit Kumar Jain

executive
#61

Capacity expansion will also be needed and that's going on right now because we need a lot of capacity for European markets and U.S. market. Right now, we are building up capacity for all these control releases and all the extended releases kind of formulations that are for additional CapEx are going on. Bio area where CapEx are going on in terms of further 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 plant. So new plants are built up at [indiscernible] and -- 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. So largely, I think almost around INR 700 crores to INR 800 crores in current year will go in the CapEx side itself.

Operator

operator
#62

The next question is from the line of Aditya Khemka from InCred Asset Management.

Aditya Khemka

analyst
#63

We understand that the prices were contracted earlier and now the rupee has depreciated. So your realization would have gone up in rupee terms. But as per my understanding of the past, so whenever this kind of thing happens, the dollar prices again get renegotiated lower. So 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 2 quarters or another year.

Ajit Kumar Jain

executive
#64

I think there are no such renegotiations of the prices where the prices are to be reduced. Rather we are increasing the prices everywhere because your costs are also moving up. All other costs are also moving up. So there are no reductions and prices are by and large, increasing only, not going down.

Operator

operator
#65

The next question is a follow-up question from the line of [indiscernible] from Bajaj Life.

Unknown Analyst

analyst
#66

Could I get a split between the domestic growth as price volume and new product launches?

Ajit Kumar Jain

executive
#67

Overall, I think volume growth is almost around 5%. Price growth is almost around another, I think, 4.5% to 5% and new product launches may be around 2% or so. So overall growth is around 13% -- compared to industry, our volume growth is.

Operator

operator
#68

The next question is from the line of Rashmi Shetty from Dolat Capital.

Rashmi Shetty

analyst
#69

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?

Ajit Kumar Jain

executive
#70

Last financial year, we had almost around close to $50 million of dollar loans, which we have completely repaid before March itself. In fact, before the dollar depreciation started, we have almost every dollar loan prepaid every dollar loan. We don't have those kind of debt in books. Currently, the debt may be around INR 193 crores in books. That's the long-term debt. We don't have 0 working capital. And I think by this year-end, what we have is INR 70 crores of term loan debt outstanding and that will be repaid completely in the next financial year. So practically, and we have more cash in books compared to the overall loans. So loans are hardly around INR 193 crores currently.

Rashmi Shetty

analyst
#71

Out of that INR 193 crores, you are saying you will be making a repayment of INR 70 crores also?

Ajit Kumar Jain

executive
#72

No, -- at the year-end, INR 70 crores will be balanced because that loan is at much cheaper rate than current market rates.

Unknown Executive

executive
#73

In mutual fund rather than -- so why should I pay on.

Rashmi Shetty

analyst
#74

Okay. And we don't have any short-term borrowings? Okay. So interest cost is expected to decline in the subsequent quarters also, right?

Ajit Kumar Jain

executive
#75

Yes, interest cost will be hardly any. We will be earning more than.

Operator

operator
#76

The next question is from the line of Ankit from Baroda.

Ankit Jain

analyst
#77

Sir just one question. Can you give some guidance on FY '20 numbers in terms of the top line growth and EBITDA.

Ajit Kumar Jain

executive
#78

I think for the current financial year, we have already given the guidance that revised guidance is around 14% to 16% kind of growth. We have revised it from 12% to 13% earlier. And EBITDA margin consolidated from 22% to 23% we have revised upward by.

Ankit Jain

analyst
#79

I'm asking for FY '28 guidance we will give at the time of quarter 4.

Operator

operator
#80

The next question is from the line of [ Saion Mukherjee ] from Nomura.

Saion Mukherjee

analyst
#81

Just one question on EBITDA margin for your consolidated business and for UniChem. If you sort of bake in all the impact of UniChem 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 and as a whole.

Ajit Kumar Jain

executive
#82

Margin, which is maybe around 26% could go up to almost around 30% kind of margin is possible. And overall EBITDA margins, maybe 2, 3 years down the line, maybe around 25%, 26% overall consolidated basis because most of the -- by the time all these other subsidiary companies will also start doing very well.

Saion Mukherjee

analyst
#83

All right. Sir, in terms of key investments, what are those investments or new initiatives, let's say, which I is planning to undertake over the next 2, 3 years, if there are any plans or thought of inorganic, organic moves, some big investment plans?

Ajit Kumar Jain

executive
#84

So right now, our investment is by and large, more is happening in biotech side. We have around almost around now 7 candidates in pipeline. We are working on more number of now. So R&D has capacity to work on at least around 3 to 4 products now every year. So -- and I think 2 products now, we have already taken the engineering batches and results are absolutely in line with what we were expecting. And I think validations are going on and a lot of investment will happen in terms of clinical trials of all these biosimilars and we are targeting all global markets and most of the products are titer values are practically double or more of the current known in the market. So we expect to do well and there will be a good amount of investment further will be happening in biotech. Current year also, we'll be investing almost around INR 100 crores more on building up the piloting facilities and additional R&D investment in biotech. So a lot of those investments are happening now. And maybe I think in 1 or 2 years' time, we may need to further increase our capacity what we have built up on biotech. So that will be another additional investment in time to come will happen.

Saion Mukherjee

analyst
#85

So sir, the EBITDA guidance or EBITDA expectation that you have factoring in these clinical trials and these investments on biotech.

Unknown Executive

executive
#86

We are factoring because next 2 years, more revenue will come.

Ajit Kumar Jain

executive
#87

Trial complete. So all those are affected.

Saion Mukherjee

analyst
#88

Right. And sir, is it possible to give some color on these products? So I mean, it seems that you're mentioning that your yields are much better than what's available in the market today. So these 7 biosimilars and 2 of them which are probably a little advanced, are these old products or are these like products which will go off patent and you will be there in the first wave in the market? And you give some color and some idea about what kind of products are you working on?

Ajit Kumar Jain

executive
#89

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. But most of the other products are patent expired products.

Saion Mukherjee

analyst
#90

Right. And you're saying in 2 years, we will start to see that means FY '29 -- FY '20 revenue will start to flow from biosimilars?

Ajit Kumar Jain

executive
#91

Yes, yes. because first, we have to produce the API, then formulations, validate formulations, do the stability, then go for clinical trials. So that process is all going on simultaneously.

Saion Mukherjee

analyst
#92

Okay. And these are like global trials, you will sort of file in U.S., Europe and out of the market?

Ajit Kumar Jain

executive
#93

Yes, put together, these are global trials, yes. We already consulted European authorities, U.K., then also U.S. for all the clinical trial protocols and all. So all protocols are in line with all these regulatory agencies.

Saion Mukherjee

analyst
#94

The filing will happen like next year, is it? Like if you have to launch in fiscal '20, in fiscal '28, you will be making your first filing. Will that be a right assessment?

Ajit Kumar Jain

executive
#95

I think this year, practically, your first is validation 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 stability -- the initial stability results will come. And thereafter, by the time we have -- we have already taken those kind of approvals. So we'll start the clinical work. And now clinical work is significantly reduced. We have also the Phase III from European authorities and also from U.S. So it's only the initial work need to be done. cost has also come down significantly now because RLD is not required for Phase III. So RLD cost becomes very high. So those exemptions have already come looking into biosimilarities and other parameters and what we have submitted to the various regulatory agencies. So overall, I think clinical things will start happening from the next financial year.

Operator

operator
#96

That was the last question for today. I now hand the conference over to the management for the closing comments. Over to you, sir.

Nitin Agarwal

analyst
#97

Yes. Thank you. Thank you very much, all the participants. Thank you.

Kunal Randeria

analyst
#98

We can close this call.

Operator

operator
#99

Yes, sir. On behalf of DAM Capital, that concludes this conference. Thank you for joining us, and you may now disconnect your lines.

Ajit Kumar Jain

executive
#100

Thank you.

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