ZIM Laboratories Limited (541400) Earnings Call Transcript & Summary
August 7, 2026
Earnings Call Speaker Segments
Operator
operatorGood afternoon, ladies and gentlemen. I'm Akash, moderator for the conference call. Welcome to ZIM Laboratories Limited Q1 FY '27 Earnings Conference Call hosted by Go India Advisors. [Operator Instructions] Please note, this conference is being recorded. I would now like to hand over the floor to Ms. Priya Sen from Go India Advisors. Thank you, and over to you, ma'am.
Priya Sen
attendeeThank you, Akash. Good afternoon, everyone, and welcome to the Q1 FY '27 Earnings Call of ZIM Laboratories Limited. We have on the call Mr. Zulfiquar Kamal, Director, Finance; Mr. Shyam Mohan Patro, Chief Financial Officer; Mr. Zain Daud, Investor Relations; and Mr. Piyush Nikhade, Company Secretary. We must remind you that the discussion on today's call may include certain forward-looking statements and must be, therefore, viewed in conjunction with the risks that the company faces. May I now request the management to take us through the financials and the business outlook, subsequent to which we will open the floor for question-and-answers. Thank you, and over to you, sir.
Zulfiquar Kamal
executiveThank you, Priya. Good afternoon, everyone. This is Zulfiquar Kamal. Speaking on behalf of the management team, I would like to warmly welcome you all to ZIM Laboratories Limited earnings conference call for the first quarter FY '27. I trust you have the opportunity to review our financial results and the investor presentation, both of which have been made available on the stock exchanges. Before I discuss our business performance for the quarter, let me begin with an update on EU GMP remediation process, which continues to remain one of our highest strategic priorities. As you are aware, our manufacturing facilities underwent EU GMP reinspection conducted by German and Portuguese regulatory authorities during May '26. The inspection has now been completed, and we are currently awaiting the final inspection report from the authorities. Based on the draft observations shared during the inspection process, we have already prepared a comprehensive corrective and prevention action, CAPA plan and are ready to submit it immediately upon receipt of the final report. Over the past year, we have made significant investments to strengthen our quality systems, manufacturing processes and compliance framework. While the regulatory process is now in the hands of the authorities, we remain confident that the extensive work undertaken over the past several months has been positioned us well for a successful outcome. With the inspection now completed, we believe the company has entered the final stage of its EU GMP remediation journey. Subject to the regulatory review process and the time lines, the successful completion of this exercise is expected to significantly strengthen our position in regulated markets and unlock meaningful growth opportunities for our innovation-led portfolio. Turning to our business performance. The first quarter reflected healthy revenue growth, supported by continued strength in our core pharmaceutical business. Our export business remained resilient despite ongoing geopolitical uncertainties in certain regions, with export contributing approximately 84% of our total operating income during the quarter. Our EBITDA margins for the quarter were impacted by planned investments in the business. These included higher employee costs following the strengthening of our senior leadership team, increased utility, fuel and power expenses, consulting costs associated with final phase of our EU GMP remediation program. I am also pleased to share that our new innovative product portfolio and oral thin films business returned to a normalized level of contribution during the quarter, accounting for approximately 18% of our revenue. We remain confident that this platform represents our most significant long-term growth opportunity, and our aspiration remains to increase the contribution of NIP and OTF product portfolio revenue over the coming years. Looking ahead, our priorities remain clear. We are focused on successful completing of our EU GMP regulatory processes, expanding our innovation-led portfolio, strengthening our global customer base and delivering substantial profitable growth. FY '27 represents an important transition year of ZIM Laboratories. With our compliance investment substantially behind us, strengthening leadership team in place and our innovation pipeline ready for commercialization, we believe the company is well positioned to enter the next phase of substantial growth. With that, I would now like to hand over the call to our Chief Financial Officer, Mr. Shyam Patro, who will take you through the financial performance for the quarter in greater detail. Over to Shyam. Thank you.
Shyam Patro
executiveThank you, Mr. Kamal. Good afternoon, everyone. Let me now take you to the financial highlights for the first quarter ended 30th June. The earnings presentation has been uploaded on the stock exchanges, and I would like to request investors to refer to it alongside my remarks. For the first quarter FY '27, the company reported total operating income of approximately INR 942 million, representing 31.2% year-on-year growth. EBITDA for the period -- for the quarter stood at INR 34 million, translating into an EBITDA margin of 3.7%. Profit after tax for the quarter stood at minus INR 40 million compared to minus INR 19 million in the corresponding quarter of the previous year. Exports continued to account for approximately 84% of our total income. The NIP, that is noble (sic) [ new ] innovative products and OTF, oral thin films portfolio contributed approximately 18% of the total operating income. The total debt stood at approximately INR 145.2 crores as on 30th June 2026. We remain focused on improving operating cash flow, optimizing working capital and managing leverage. The company invested INR 82 million towards R&D during the quarter. Overall, the first quarter reflects an organization investing for long-term growth and maintaining healthy business momentum. With that, I would like to open the floor for questions. Thank you.
Operator
operator[Operator Instructions] The first question comes from the line of Mr. Mahesh Tolani from Goquarter. As there is no response from Mr. Mahesh, we are taking the next question from Mr. Rohit Balakrishnan from ithoughtPMS.
Rohit Balakrishnan
analystSo just a few questions. So I think this quarter, when I compare this quarter versus, let's say, many of the last Q1s, let's say, from FY '21, '22, this is probably one of the highest. So in terms of the business momentum, how do you see, sir, for the coming quarters for this financial year? And second question was in terms of expenses, I see like the other expenses now settling in at about INR 34 crores, INR 33 crores a quarter, and we also saw like expansion in employee expenses. So is this the normal base now? Or was there some any one-offs in this quarter? This was a couple of questions. And then I have just 1, 2 more. So yes.
Shyam Patro
executiveYes. So I think on the first question. Yes, you're right. This was a good quarter for us, one of the better Q1s over the past few years. This is just a result of the increased business that we have gotten from the formulations business piece also now. As we have said, we have the team in place, and now we are reaching out to more relationships and further filings that are happening. We were also quite happy with the performance of the innovative product portfolio, which contributed a lot compared to previous quarters in this time. So I think with both, I feel like going forward, it will depend on the EU situation of how the quarters go. But we do expect that the base business and other business -- the innovative product business keep on continuing to grow. So over the quarters, I believe the base business should also grow with the innovative product portfolio also growing. But on a total level, it will depend a lot on whether the EU GMP comes and when it comes. It's just about timing now. So hopefully, that will come soon enough and then we can start getting revenues from EU. On the expense side, I'll let Mr. Zulfiquar Kamal take that.
Zulfiquar Kamal
executiveYes. On the expenses side, what you have rightly mentioned, it has more or less settled, except for there is some onetime expenditure of the Q1 -- in Q1 also. I think I'll let Mr. Patro give the details of the Q1 expenses, which are only onetime. Over to Mr. Patro.
Shyam Patro
executiveSpecifically, onetime expenses are in the form of TGA audit that is Australia -- around INR 30 lakhs, consultant engaged for this European audit, some repair and maintenance has been taken off for a smooth EU GMP audit and some MIDC services that comes to near about INR 191.9 crores. So that has given more like a run rate increase for this overall business onetime expenses. This will not be repeated in the next quarter. So we can have a better result in next quarter.
Zulfiquar Kamal
executiveYes. So to answer your question, the quarterly expenses, all other expenses are now -- are fixed in the same nature, and it will not be increased going further.
Rohit Balakrishnan
analystRight, sir. And sir, from the perspective of the EU GMP, I think we were expecting somewhere in July or first week of August, I think. I mean we are pretty much on that time line now. So anything that you can share, like any communication that you've got from the regulator?
Shyam Patro
executiveYes, Rohit. So we've received the draft inspection report from the regulator, which gives us an insight into what the final report will be like. But the final report is yet to come. We are in communication with the authorities constantly and have been informed that the report should come any time now. So we are hoping that this should come in a week or 2 weeks, the final report should be in our hands.
Rohit Balakrishnan
analystGot it. And sir, last question was, sir, if you see the gross margin, I think this was pretty high, 58.1%. We've done maybe this once in a quarter types in the last 4, 5 years. So is there some one-off here? Or is it now more a trend because we've been around 55%, 56% on a regular basis. But 58% seems to be on the higher side. Is it driven by the formulation push or more product mix or anything you would like to call out? And is it like the more normalized gross margin now as we push towards EU and more NIP?
Zulfiquar Kamal
executiveYes. So you are right. It will be around 55% to 58% because of the product mix in the first quarter. But going forward, the increase in the NIP business will make this transition more attractive going private.
Operator
operatorThe next question comes from the line of Mr. Deepesh from Maanya Finance.
Deepesh Sancheti
analystAm I audible?
Operator
operatorYes, sir, you are.
Deepesh Sancheti
analystYes. My first question was, can you comment on the company's debt levels and plans of deleveraging?
Zulfiquar Kamal
executiveMr. Patro?
Shyam Patro
executiveThe term loan we have taken for CapEx. CC limit has also been utilized. The total borrowing stood at INR 145 crores at the moment as on 30th July -- 30th June.
Deepesh Sancheti
analystOkay. And what is the cost of capital?
Shyam Patro
executiveIt's like -- that is like were in similar to earlier quarters, below 10%.
Deepesh Sancheti
analystBelow 10%?
Shyam Patro
executiveYes.
Deepesh Sancheti
analystOkay. So how do you plan to improve your operating cash flow and working capital?
Zulfiquar Kamal
executiveYes. So our -- going forward, our -- we are mostly dependent on the next year's revenue projections and doing quarterly revenue projections, which are going to come in the current year. That will give us leverage [indiscernible].
Operator
operatorKamal sir, I'm sorry to interrupt you. Your voice was not audible, sir.
Zulfiquar Kamal
executiveYes. So what we expect is once the revenue start growing, we'll be able to generate enough cash flows, which will be required for the coming quarters, number one. And if you have observed from the current year. In the current quarter, the debtors and inventory limits were a little bit higher side. So we are now improving our cash flows by increasing our collection in debtors, which is from around more than -- it's around 100 days. We are targeting to reduce it to around 80 days. So some collection will come from the debtors and also we'll be having enough control on our inventory level. So this will give us a sufficient cash flow going forward. And these are the 2 measures which we are taking for improving our cash flows and working capital.
Deepesh Sancheti
analystOkay. So what -- and as seen previously in the previous quarters, what do you think are the key risks that investors should monitor over the coming quarters?
Zulfiquar Kamal
executiveSo as of now, the key risk only remains the EU GMP, which is going -- which we are expecting in this quarter to come. Rest, everything is in place. As we have already mentioned earlier in the call, our product portfolio are nearing completion. MAs are -- we are receiving all our MA queries. So market authorization from Europe are also there. Our marketing team is also being placed. So as such, except for this EU GMP, nothing remains, which will be anything to worry about.
Deepesh Sancheti
analystWe see a lot of -- I mean, changes in the operating margins. What should be the operating margins going forward, which investors should expect from the company?
Zulfiquar Kamal
executiveSo it will be more on the similar line going on the positive side with the increase of the NIP and the oral thin film products.
Deepesh Sancheti
analystBecause this quarter, the margins were around 2.6%, whereas last year, it was about 6% and even last quarter, we saw around 6% and 7%.
Zain Daud
executiveYes. So see, this is -- I think you're talking about EBITDA margins.
Deepesh Sancheti
analystYes.
Zain Daud
executiveThis basically is an impact of the top line, like we have shown the expenses that increase. So there are some expenses -- we have increased our expenditure, and this is something that will be settled now. So as we cross a higher revenue, margins will improve.
Deepesh Sancheti
analystBecause point one, what happens is when the margins actually lower down, even if you find the sales growth also because right now, we're not finding a sales growth, but if we find the sales growth also, some of the ROE is just too low. I mean, for a 2% ROE, even historically, we've always been below -- I mean, below 5%. It's very concerning for the investors. So how do you plan to improve that on the ROE level, especially? Because we're ticking a debt of around -- see, our cost of capital is around 10%. And if we are not able to do even 5% as ROE, I mean, then I would rather keep my money in the fixed deposit. I mean, just...
Zulfiquar Kamal
executiveNo, I understand your point because we are on the level where we are expecting our EU GMP and the growth coming from the EU GMP [Technical Difficulty].
Operator
operatorKamal sir, sorry to interrupt, your voice is not so clear, sir.
Zulfiquar Kamal
executiveYes. So what I'm trying to say, this is the baseline growth as of today of the revenue. Once we get the EU GMP certification, our revenue and contribution of oral thin film and NIP to the regulated market will grow. This will increase our top line, thereby increasing our EBITDA margins. We have already said earlier, the EBITDA margin, what we are projecting will be in upper teens in the -- previous call, which we have -- earlier, we have mentioned. So the main point is only we are waiting that the revenue should grow post receipt of our EU GMP certificate.
Deepesh Sancheti
analystSo that will be the inflection point, right, for the company?
Zulfiquar Kamal
executiveYes.
Deepesh Sancheti
analystSo just want to understand, once that comes in, in how much time would we actually see the sales growth coming? I mean, after the certificate also coming, immediately the sales will start or there will be a lag effect of about a month or maybe a quarter?
Zain Daud
executiveI think it's about 2 quarters that will be the lag. We expect -- if it comes in August, we expect some supplies to start going in the last quarter, Q4. And then so on, there will be a continuous supply.
Deepesh Sancheti
analystSo assuming that we get -- everything falls in place by the grace of God, if everything falls in place, what will be your FY '28 expectations?
Zain Daud
executiveI think we would grow at 30% to 40% if we get EU GMP and if supplies start. That will be the full year for FY '28 would be about 30% to 35% growth easily.
Deepesh Sancheti
analyst30% to 35% growth that will be a?
Zulfiquar Kamal
executiveTop line.
Deepesh Sancheti
analystTop line. So that will be what, approximately INR 500 crores?
Zulfiquar Kamal
executiveYes, you could say that, but it will be more conducive to give this once we have the EU GMP. It's an intricate kind of process that happens once the supply starts. So we'll keep you updated as the quarters go by.
Deepesh Sancheti
analystPerfect. So if I get things right, if we get the EU GMP and everything falls in place, we should see 30% growth and mid-teens EBITDA margin. Am I getting that right?
Zulfiquar Kamal
executiveYes.
Deepesh Sancheti
analystGreat. All the very best guys. And we've been long-term investors. So we are hoping that things fall in place.
Operator
operatorThe next question comes from the line of Mr. Vishal, an individual investor.
Unknown Attendee
attendeeAm I audible?
Operator
operatorYes, you're audible.
Unknown Attendee
attendeeSir, first question would be on the EU GMP approval only. So whether any remediation or CAPA needs to be further submitted by us against the observation what we have received or we have already submitted and now we are waiting for the final approvals. My first question is that.
Zain Daud
executiveSo yes, we'll have to submit a CAPA based on the final inspection report. Like we said, we have received the draft report. And based on that, we are ready with the CAPA. So as soon as the final inspection report comes, we will submit the CAPA.
Unknown Attendee
attendeeOkay. So any major or any adverse observation in the draft report?
Zain Daud
executiveNo, there are no adverse observations. There is no critical observations, which is what is important. There are only some major observations which will be handled and there should not be any...
Unknown Attendee
attendeeMajor or minor observation, sir?
Zain Daud
executiveThere are both, some major and some minor observations. But no critical observations.
Unknown Attendee
attendeeSince we had engaged third-party agencies, and we had taken a lot of due diligence and still its major observations are being reflected. So I mean, what would be the take of the management in that regard?
Zain Daud
executiveSee, I think major observations is a common thing in reports. It is very rarely that you get only minor observations or 0 observations. The important part is you not get any critical observations because that is what can hamper your EU GMP certification. So even every time we have been recertified, we had major observations, but it was not something that cannot be rectified and does not affect product quality.
Unknown Attendee
attendeeSo the -- I mean, whatever compliance we submit, that will not entail a further audit from the authority, right, sir?
Zain Daud
executiveNo, it will not. And one more thing...
Unknown Attendee
attendeeSo it's just a matter of...
Zain Daud
executiveNormally they combine 4 or 5 minor observation to major. So effectively, if you drill down the major, it is minor ones.
Unknown Attendee
attendeeOkay. So I mean, our remediations is CAPA submission would suffice to get the approval rather than a reinspection by the auditors, right?
Zain Daud
executiveYes, correct. The CAPA will be enough. Once accepted, we should get the recertification.
Unknown Attendee
attendeeOkay. And my second question was on the, sir, our NIP and OTC pipeline, so which has been given in, I think, Slide #15 and 16. The product, sir, there has been -- I mean, almost remained stagnant for last 3 to 4 quarters in terms of new filings for NIP and OTF. So any outlook or color you can give on that? I mean how that will progress over a period of next, say, 12 to 18 months?
Zain Daud
executiveSo see, we have filed most of the products in Europe. When the EU GMP went under remediation, they stopped giving us the MAs, but the procedure was ongoing for some of these products, and we are near the end for most products that have been filed. Once we get the EU GMP, we'll start getting the MAs.
Unknown Attendee
attendeeBut sir, I mean, you have categorized the products under various phases like market review, formulation development, validation, BE study. So I mean, this -- I think these are -- all these things have to be done at in-house. So were there not any development in any of the new products because this has not been updated for last many quarters, what I have seen. I mean, the same product, 12 products in NIP.
Zain Daud
executiveYes. So the major development time which is needed for the products is for these prefiling stages only, which is basically the validation batches, the stability studies, et cetera. So that took about 1.5 to 2 years, and we got those done. So the filing process itself takes about 210 days if there are no questions from the authorities. But usually, there are some clarifications that are needed by the authorities and they ask for clarification when the clock stops. So that process also becomes a bit lengthier. So this has -- you're right, this has not been updated for the past year or so because we are in that regulatory filing stage. But now what we are saying is we are towards the end of the regulatory filing stage, and we have submitted most of the queries that the auditors had. And we are now expecting MAs to come through once the EU GMP comes. So we will have the registrations as soon as EU GMP comes through.
Unknown Attendee
attendeeOkay. So how do we see this product pipeline, sir, I mean, the next 12 to 18 months, I mean, from 12 products [ availability ] significantly, how much we can expect I mean, new products coming...
Zain Daud
executive8 to 10 products -- we will have MAs for about 8 to 10 products once EU GMP comes.
Unknown Attendee
attendeeHello?
Zain Daud
executiveHello, can you hear us?
Unknown Attendee
attendeeYes, you are audible.
Zain Daud
executiveSo we'll have approvals for 8 to 10 products once EU GMP comes through, and we'll try to commercialize as much of these as we can.
Unknown Attendee
attendeeIn anticipatory, I mean, inventory you are building up, sir, in anticipation of this approval coming in, have we already started building up the inventory or we would like to have the approval first and then...
Zain Daud
executiveYes. See, we are building up inventory on API for some of the key products where we estimate that time lines would be longer. It's product to product mainly. It's not a general inventory buildup. It is more on which products APIs are scarce and it takes time for them to be available. For those, we are building up inventory. For others, we are going to be basically just in time. And when the orders come, we are going to build inventory according to that.
Unknown Attendee
attendeeThank you for all the communication you are maintaining with the investors and the transparency that is being maintained by the company. And we expect that this will continue in future also.
Operator
operator[Operator Instructions] The next question comes from the line of [ Mr. Nikhil Gupta from Vayu Capital ].
Unknown Analyst
analystMy first question is on our Australia market. I think we have received an MA for a particular benzoate. When we can expect the revenues start flowing from that product?
Zain Daud
executiveYes. So as you saw in the presentation, we also underwent the TGA audit from Australia in the month of April. So I'll just give an update to investors on that. We have received the report, final report, and we submitted the CAPA. Now the assessors are reviewing the CAPA. So we expect the TGA certification also to come through in the coming months. We have received an order for one of the products from Australia, and we are going to start supplies, I think, in the next 2 to 3 months.
Unknown Analyst
analystSorry, I'm not very clear, sorry. So which slide I think I'm not able to see any CAPA on the Australia side in the presentation?
Zain Daud
executiveSo yes, in the slide, which is basically telling you about the EU GMP remediation, at the bottom, there is a note where we have said that we did undergo a TGA audit. Slide #6 of the presentation. So the TGA is -- like for EU, there is EMA, the European Medicine Agencies. For Australia, it is the TGA, Therapeutic Goods Administration. They came to the plant in April, audited us and have given an inspection report. We have responded to the inspection report with our CAPA. And now we are awaiting the assessor's response and giving us the certificate. They were positive on the outcome, and they communicated to us that as long as our CAPA is in line, we will be getting the Australian certificate. So based on that, you will find the details in the Slide #6.
Unknown Analyst
analystRight. It's clear. So how much big is the market for that particular product in Australia?
Zain Daud
executiveI think we are starting slowly with one product, but we expect more products to come through. Market size for that product in Australia is about $20 million, but there are only a few players there. So we expect to get a good chunk of the market.
Unknown Analyst
analystRight. My last question is on a general business understanding. Maybe I'm not clear. So as per my current understanding, I believe for the OTF segment, very few players in India have the current technology to make those products. One is, I believe, is Aavishkar, which is in the unlisted space. And I believe, second, we have developed that technology and have the patent for global markets as well. So is that a fair understanding or there needs some correction to the understanding?
Zain Daud
executiveSo you are right, there are a few players only in the oral thin film space and fewer when it comes to an European GMP-certified facility. So we are one of the few people who have filings and approvals in Europe. So that we believe will give us an edge at least when it comes to Europe because we will be one of the few players to have approvals like for [ sildenafil, linagliptin ] having approvals in Europe.
Unknown Analyst
analystRight. So is it a fair understanding to say that in India, there are no more than 2, 3 players along with us? And can you quantify just an estimate number for Europe as well, the people who can do it?
Zain Daud
executiveI think as far as I am aware, there are 2 to 3 players in India in the pharmaceutical space. In Europe, I'm not aware of many players who are doing oral thin films. So that would be something that you'll have to check. U.S. has players, but U.S. has the innovator basically who is doing Suboxone, that is buprenorphine and naloxone. That is a European and U.S. player. So that is the biggest player in oral thin films, and there are some in Nutra space also in the U.S.
Operator
operatorThe next question comes from the line of [ Pujit Aggarwal ] an individual investor.
Unknown Attendee
attendeeAm I audible?
Zain Daud
executiveYes, Pujit.
Unknown Attendee
attendeeSo I just wanted to understand, like, I mean, in terms of R&D expenditure, we've actually expensed a lot of money in terms of R&D. I just wanted to understand whether we, as ZIM Labs can make 15% to 20% ROIC like -- and by when can we expect to make that 15% to 20% ROIC as a company?
Zain Daud
executiveYes. So see, I think R&D is the DNA of this company and all investments are being done for a long term. We do believe we can get the returns and most of this will be unlocked once EU is available with us because these investments that you see are being done, keeping in mind the developed markets from where the major revenue is going to come. So I do believe we can get the returns. This is a long-term play for us.
Unknown Attendee
attendeeGot it. So like, I mean, last year, we had quite a few key hires. So can you just give us a brief about how the key hires are performing? And how capable do you think we, as a company are to scale our revenues up 30% to 40%? Do you think we have that capability in terms of scaling up the revenues from the targeted market that we are anticipating, do you think we, as a company, have an infrastructure ready to...
Zain Daud
executiveYes. So I think, Pujit, this is an exercise by and large to professionalize the company to bring in seasoned talents. And like you've seen, we've hired technical -- on the technical side and also on the administrative side, but the biggest hire has been the Business Development President that has come in. He brings with him a lot of experience into newer markets where we were not present. So yes, we do expect that along with Europe, the RoW business will also give us good growth. There are a few leadership positions that we are looking to hire more and even strengthen the organization even more. So you will see more developments as we go along in terms of organizational restructure. This is an attempt to make the organization systematic and professional.
Unknown Attendee
attendeeGot it. So in terms of employee cost, what kind of run rate -- I'm sorry, I missed that part in the con call. Like what -- is INR 19 crores the new normal in terms of quarterly run rate? Or what should I assume the new normal to be?
Zulfiquar Kamal
executiveYes, it will be on the same line, except for. Yes, can you hear me?
Unknown Attendee
attendeeYes, yes.
Zulfiquar Kamal
executiveYes. So as you said, the run rate will be on the similar side, except for the few around what Mr. Patro suggested that some of the expenditure of -- amounting to around INR 1.25 crores in this quarter was onetime. Rest, all expenses have been now completed, except for a few hirings which Zain mentioned. Other than that, we have been now normalized our run rate as far as the expenses are concerned.
Shyam Patro
executiveIf I repeat, INR 1.82 crores is the onetime expenses incurred in Q1, specifically to EU GMP and high-value human assets, placement charges, repair and maintenance done for EU GMP inspection.
Operator
operatorThe next question comes from the line of [ Nishita Shanklesha ] from Sapphire Capital.
Unknown Analyst
analystAm I audible?
Zulfiquar Kamal
executiveYes, you're audible.
Unknown Analyst
analystYes. So I just wanted to understand, you mentioned that we can do around 30% to 40% growth in FY '28. So how much of that growth can we attribute to us getting EU GMP?
Zain Daud
executiveSee, I think at least 60% of that growth is attributed to EU, 60% to 70% because that is where the value unlock will happen. RoW business and base business will continue to grow at steady levels, but the major jump that we are looking for is going to come from EU.
Unknown Analyst
analystRight. So like -- so then because you mentioned that we are expecting the EU GMP to come and then it will take around 2 quarters for us to start the supplies and everything. So then is it safe to assume that FY '27 is going to be very flattish compared to FY '26? What sort of growth can we see in FY '27?
Zain Daud
executiveSee if we don't -- let's say, if EU doesn't come or if you assume EU comes from FY '28, we will still have a 10% to 15% growth in the FY '27 year compared to the previous year because as we said, the base business is growing, the new hires are coming into motion. So we do expect there will be 10% to 15% growth. I don't believe it will be a flattish year for us compared to FY '28.
Unknown Analyst
analystRight. Okay. So like 10%, 15% growth. And then the EBITDA margins because if EU GMP doesn't come, then like -- or comes from FY '28, then EBITDA margin for FY '27 can we assume to be in single digits like because we -- our employee cost is now INR 19 crores quarterly run rate. So like can we assume it to be in mid-single digit?
Zain Daud
executiveI think we would assume it to be similar to the last year, around that range because like in the first quarter, margins improved. We assume that it would be in similar range to...
Operator
operatorSorry to interrupt, sir, Kamal sir, your voice is not heard.
Zulfiquar Kamal
executiveI said the previous year does not [Technical Difficulty].
Operator
operatorKamal sir, I'm sorry to interrupt you one second, sir. We are unable to hear you properly.
Zulfiquar Kamal
executiveYes. I was saying -- can you hear me now?
Operator
operatorYes, sir.
Zain Daud
executiveYes. So I'm saying that if EU GMP starts from FY '28, we assume, then the margins -- EBITDA margins would be similar to the last year around that percentage.
Unknown Analyst
analystAm I audible?
Zain Daud
executiveYes, you're audible.
Unknown Analyst
analystYes. Understood. So my last question would be on what is the total CapEx spend we are going to do this year in FY '27?
Zulfiquar Kamal
executiveSo CapEx is mostly completed now. We have been able to close all our CapEx and the projects are going to start somewhere in the second quarter. So as such, only normal upgradation expenses may be there, CapEx will be there. And the amount what we have assumed from the press, that will be the only requirement, which is there, which has to be completed, which is around INR 15 crores to INR 20 crores to upgrade the enzyme plant and the Nutra plant.
Operator
operatorThe next question comes from the line of [ Mr. Rupesh Tatia ] from Long Equity Partners.
Unknown Analyst
analystI had 2, 3 questions. So first question, sir, is on the Star Product 1, which I assume to be enzymatic product. So is EU GMP the only thing pending to get MA approval to our partner in U.K.
Zain Daud
executiveYes, that's correct. We are awaiting the MA for -- that will come after the EU GMP.
Unknown Analyst
analystBut I mean, all the clarifications, any questions, everything has been answered. Is that a fair understanding?
Zain Daud
executiveYes, that has been answered, and we are at the end of procedure. All the requests for information have been replied to.
Unknown Analyst
analystOkay. Okay. And second question, sir, I joined the call a bit late. Did you say we will get formal letter for EU GMP in another 2 weeks?
Zain Daud
executiveSo it was supposed to come in the month of August. We do expect it to still be on time line and come within the next 2 weeks.
Unknown Analyst
analystAnd then how much time after that for CAPA and then final approval?
Zain Daud
executiveI think it will take about 2 to 3 months. So by the end of the year, we should be ready to be in a position to supply to Europe. So maybe quarter 4, we can see some revenue starting to come in.
Unknown Analyst
analystAnd you still expect that -- because I think the branded brand products capacity, I think, is going to come online in 2027. So you still feel we will be able to capture a decent market share in at least U.K.
Zain Daud
executiveYes, we will. We will be. Because we do have contracts with the companies. And based on what our clients are saying, we still believe that there is potential -- big potential for these products.
Unknown Analyst
analystOkay. Okay. And then the third question, sir, this Neuraxpharm approval for Buprenorphine. So can you give some update about that? How -- I mean, what is happening there? That also, I mean, will we get orders once we get EU GMP? And just small clarification there, will we launch this product in U.K. also?
Zain Daud
executiveSo yes, Neuraxpharm has -- their agreement states that they'll be launching in U.K. also. Their business plans were put on hold because of the fact that we were under EU GMP remediation. They have given us a positive outlook on the product once the EU GMP comes back. So I believe it will be fair to assume that once we have the GMP back, there will be orders.
Unknown Analyst
analystBut this is still at discussion stage, you would say?
Zain Daud
executiveNo, it's not a discussion stage. It's their MA basically. They are the ones who are the MA holders. So they will decide when to launch. The development has been done by them. They have given us a license fee for it. The MA is under their name. They will be deciding when to launch it. But they're waiting primarily for our EU GMP.
Operator
operatorThe next question comes from the line of Mr. Madhur Rathi from Counter Cyclical Investments.
Madhur Rathi
analystSir, you mentioned that this year's EBITDA margin should be closer to what we did in the past year. But I think in the previous quarter, we were expecting some mid-teens kind of margin. So why is this even without the -- so where are we struggling? I think revenue growth is coming, but the margins are not flowing in. So if you could help us understand?
Zain Daud
executiveSo see, we are projecting last year's EBITDA margins on a higher revenue this year because of the costs that have come. So we believe that if without EU, if we look at INR 410 crores, INR 420 crores number, we would have EBITDA margins similar to last year because of the increased costs.
Madhur Rathi
analystSir, but these costs were on a similar level. I think if I look at our Q-on-Q numbers, most of the costs are similar. So even then we were expecting -- so only the INR 2 crore incremental cost related to employee expenses has come in, but that is proportionately offset by our gross margin improvement. So is that, that whatever gross and EBITDA margin improvement we are expecting will be only driven by these regulated market products going forward? Is that understanding correct?
Zain Daud
executiveThat is a part of it, but higher revenues will also trigger a better margin profile, with the operating leverage will kick in beyond a certain point. And once we have revenues above INR 100 crores, we'll have better margins because the cost will be absorbed.
Madhur Rathi
analystRight. And sir, these 8 to 10 MAs that we have, sir, so these are MA that we already have. So whenever the EU GMP accepts our CAPA gives us the final certificate, we can start it within like 2 quarters, we can start supplying these products, right?
Zain Daud
executiveSo we don't have the MAs yet, but what happens is if you don't have a valid EU GMP certificate, the authorities don't issue an MA to you. We are near the end of the procedure of the 210-day clock that is the prerequisite to get an MA. So we are towards the end of that. So it's an assumption -- fair assumption to say that once we get the EU GMP, they'll grant us the MA. That is the only thing holding the MAs right now. Our questions and queries have been answered, the queries raised by the assessors have been answered.
Madhur Rathi
analystSo these MAs have already been filed?
Zain Daud
executiveThe filings have been done, correct, and the responses have been given. We are near the end of the 210-day clock.
Madhur Rathi
analystOkay. So in a scenario where the EU GMP is delayed by maybe 1 or 2 months, does the whole process needs to be redone for these MAs to get -- so either in our partners' name or in ZIM's name. So will the whole process need to be done again?
Zain Daud
executiveI don't think so because they give you time to get the EU GMP. Obviously, if it goes beyond 3 to 4 months, it will have to be redone. But right now, with the time line that we have in front of us, it won't need a refiling.
Operator
operatorThe next question is a follow-up question from Mr. Rohit Balakrishnan from ithoughtPMS.
Rohit Balakrishnan
analystYes. Sir, most of the questions have been answered. One clarification was that, I mean, sir, like I -- usually, Q1 is the slowest quarter for us. And then typically, if I see that Q1 to the next full year is around 4, 4.5x historically. So by that logic, we should be close to that INR 430 crores, INR 450 crores kind of revenue full year without assuming [indiscernible] no change in EU, et cetera. So with that scale also, I mean, I understand there has been some kind of cost increases in the last 3 quarters. But I mean, -- because earlier, we used to do 12%, 13% margins without factoring in the regulated markets business. I understand that we have hired a lot of people and we are pushing even in the non-reg markets for newer markets. So given all this, I mean, forget this year, let's say, if you were to look at your business for 1 minute without EU, for 1 minute, just to understand how you are thinking, the current business, will that be able to do double-digit margins, let's say, if you do -- let's say, close to INR 500 crores of sales, maybe not this year, but let's say, next year? I'm only talking about -- consciously only talking about the EU business -- non-EU business, the non-regulated business at this point of time, just to understand that economics.
Zain Daud
executiveSo see, if we do -- INR 410 crores to INR 420 crores what we are projecting, then we are looking at margins similar to last year. But if we do INR 450 crores or INR 460 crores, then obviously, the leverage kicks in and we are looking at higher EBITDA margins, then we would be around mid-teens or near, near 13%, 14% is what we should be getting at. So if at INR 450 crores, you look at definitely higher margins, but what we are projecting without EU, let's say, 10%, 15% growth, then we are looking at last year's margins.
Rohit Balakrishnan
analystOkay. And this is despite you having a very good Q1, right? Because, sir, I'm just cognizant of the fact that last 5 years, this is the best Q1 that we've seen. So I mean, just to sort of put that in context or probably even 6 years.
Zain Daud
executiveYes, that's correct, revenue-wise.
Rohit Balakrishnan
analystYes, I'm only talking revenue right now because for the simple fact that we have incurred costs and those costs -- and Q1 is the smallest quarter for us. So you still think that it's only INR 420-odd crores that you could do without EU or...
Zain Daud
executiveSee, that is the projection and outlook right now. Obviously, things will become more clearer around the second quarter ending. So when we have the second quarter call, I think that is the time when we would be able to tell you that whether we are overshooting the INR 420 crores number.
Rohit Balakrishnan
analystSure. Sure. And given this overall Middle East disruption, which keeps coming back every few days, so I mean, how -- are you seeing any kind of impact because of that, sir?
Zain Daud
executiveSorry, what was the question? Can you repeat it?
Rohit Balakrishnan
analystYes. No, I'm saying that the disruption in the Middle East because of the ongoing conflict, are we seeing any impact because of that in our business? Or is it -- yes, that's the question.
Zain Daud
executiveWe did see some impact in the first quarter. But right now, it seems to be regularizing. It is not playing that bigger role, and we feel like it might regularize further if this is how the situation is. But you can never know if it worsens, then definitely it will have an impact.
Operator
operatorWe have a follow-up question from Mr. Nikhil Gupta from Vayu Capital.
Unknown Analyst
analystSir, my only question is related to our partners. I think last -- in the last call, we mentioned our strategy that while we are simultaneously working with the EU GMP, we are looking and we have partners in place where we can use their facility and use our products to manufacture and supply. So what's happening on that front?
Zain Daud
executiveSo I think what you're talking about is a CDMO model where we develop for -- so we are not into pure contract manufacturing. We have our own products, and we develop our own products and we manufacture for others. So that is a pure B2B model that's going on, and that's what is the base business about in formulation, especially. So that's going on.
Unknown Analyst
analystSo my understanding was that we are using other facilities, which already have the EU GMP. We are exploring that particular option so that whatever MAs are in place, we can deliver the supplies. So that understanding is not correct, you're saying?
Zain Daud
executiveNo, that is correct. We do have an alternate site where we have transferred basically, we are manufacturing a couple of products as a risk measure and a good risk practice. That's going on. We have completed the batches. That batches are under stability right now. Once the stability completes, we'll be in a position to supply from those plants as well.
Unknown Analyst
analystYes. So let's say, if we go deep in that relationship and explore other sites as well. So in that sense, our impact of EU GMP gets -- the impact gets minimized, right? So what's your take on that if we simultaneously start exploring that particular segment?
Zain Daud
executiveSee, there is a lot of regulatory processes that are also there when you transfer to another site. You have to file with the authorities again. Your current filings have your manufacturing site in the dossier. And if you transfer it to another plant, then you have to again file a variation. So that is not our primary strategy. We still are looking to manufacture most of the products in-house because we have the equipment we spent on it. So I believe that strategy will be limited to a few products and a few key markets, but not as a whole strategy to kind of look at the entire EU GMP remediation. We are still -- our primary strategy is to manufacture in-house.
Operator
operator[Operator Instructions] There are no further questions. Now I hand over the floor to the management for closing comments.
Zulfiquar Kamal
executiveSo thank you very much for giving us the time and attending the call. Again, I thank the team, Go India team for very well organized this call. Thank you very much.
Operator
operatorThank you, sir. Ladies and gentlemen, this concludes your conference for today. On behalf of Go India Advisors, we thank you for your participation and for using Door Sabha's conference call service. You may disconnect your lines now. Thank you, and have a pleasant day.
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