Eris Lifesciences Limited ($ERIS)

Ladies and gentlemen, good day, and welcome to the Q4 and FY '26 Earnings Conference Call of Eris Lifesciences Limited. Today, we have with us on the call Mr. Amit Bakshi, Chairman and Managing Director; Mr. V. Krishnakumar, Chief Operating Officer and Executive Director; Mr. Sachin Shah, Chief Financial Officer; and Ms. Kruti Raval, VP, M&A and Investor Relations. [Operator Instructions] Please note this call is being recorded. I would now like to hand the conference over to Mr. V. Krishnakumar, Chief Operating Officer and Executive Director. Thank you, and over to you, sir.

Welcome to the quarter 4 and full year results presentation. We will structure the discussion in 3 parts as usual domestic formulations, international business, and the consolidated statements. So first with the domestic business results. In quarter 4, our domestic business grew by 12% and EBITDA grew by 10% with a margin of 37%. For the full year, our revenue growth was 11% and EBITDA growth of 12% with a 37% margin. EBITDA margin expanded from 36.5% in FY '25 to 37% in FY '26. In terms of absolute numbers, quarter 4 revenue was at INR 671 crores and the full year DBF revenue was at INR 2,778 crores. Quarter 4 EBITDA was at INR 246 crores, 10% margin slightly depressed because of the semaglutide pre-launch expenses. Full year EBITDA for DBF was INR 1,026 crores, which is 12% year-on-year and EBITDA margin expanded from 36.5% in FY '25 to 37% in FY '26. So looking back at the key hits and misses during the year. The key misses were largely 2. Number 1, there was a revenue loss of around INR 55 crores to INR 60 crores because of significant new launches that were earlier planned, but then they had to be abandoned or delayed. So gSaxenda was a weight loss SKU of liraglutide. We had to abandon that due to a delayed regulatory approval. And Aspart and Esaxerenon which were 2 very important launches planned for FY '26, got deferred to FY '27 on account of regulatory delays. On the insulin side, we again incurred a sale loss of around INR 50 crores in FY '26 on the back of a similar number in FY '25. Because the insourcing of the products and the commercial manufacture from Bhopal has been delayed by nearly a year, again, on account of regulatory delays. So -- while we continue to be dependent on third-party supplies in FY '26, we had to take this revenue loss because the supplies were not commensurate with the demand. And thirdly, our critical care business did not take off as expected. Looking at the things that worked very well, the insulin segment performance, the numbers speak for themselves. Our market share in RHI cartridges increased from 13% to 24% during the course of the year. Our market share in the overall insulin segment, which is RHI plus glargine, increased from 12% to 16% during the year. And the growth in insulins for us outpaced the covered market growth by nearly 5-fold. The CVM growth was 6.7%, and the Eris growth was 32%. The Derma segment consistently outperformed its covered market in all 4 quarters. For the financial year, Eris growth was 14.2% versus the covered market growth of 8.6%, with EBITDA margin well above the DBF average of 37%. Our semaglutide brand, Sundae, has taken off to a robust start. We launched the product in 2 presentations, vial and pen. And for the very first full month, that is April 26, as per the reflection in IQVIA, Eris is ranked #1 in injectable semaglutide by sale volume, and Eris is ranked #2 in the injectable semaglutide by sale value. We take this as a strong reflection of the present strength of the Eris injectable diversity platform. Moving over to the key numbers. As per IQVIA, the Eris market share in injectable Sema by units started at 13% in March and stood at 22% in April. Eris market share by sale value started at 5% in March and stands at 13% in April. By way of prescription share, Eris market share in injectable Sema stands at 22% in May, having started at 8% in March and 18% in April. So the other noteworthy point here is that we launched the vial in March, and we launched our pen in mid-April with just 1 SKU, which is 2 mg. But despite that, we clocked a market share in the pen segment of 11% by volume and 6% by value. So recapping the salient features of our semaglutide launch. The market size and structure is evolving in line with our expectation. So the market size estimate in the first month was INR 1.5 lakh to INR 2 lakh active users of generic semaglutide. Over 75% of the prescriptions are being driven by diabetes rather than obesity. Vials, as a percentage of the overall injectable market, stood at 21% in April. This is by volume and we expect this number to settle down at 25% to 30% on a steady-state basis. Our Sema launch was in a phased manner post the loss of exclusivity. We launched Sundae Vial in March. Sundae Pen 2 mg came in mid-April. We launched the 4 mg Sundae Pen in early May and we expect obesity SKU to be launched in July. Our products are priced lower than competition. We believe that these are more sustainable price points in the long term. Our vials are priced at INR 1,290 per unit, and our pens are priced at INR 3,200 per unit for both the 2 mg and the 4 mg SKUs. Happy to note that our first month performance validates our ongoing thesis of being able to take a leading position in Sema based on the strength of our insulin franchise. Three aspects of this which we would like to recap. 1 is our patient care platform, which is focused on developing and nurturing long-term relationships with patients. Secondly, our credibility and market share with the key opinion leaders in the diabeto-endo space and the long-standing experience and supply chain of handling cold chain products. We expect tailwinds for Sundae Pen starting Q2 of this year because, A, we would have insourced the manufacturing of Sundae Pen with a Phase I insert capacity of 5 million units per annum. And this will lease out any teething, supply issues alongside considerable margin improvement. Moving on to our DBF business guidance for the current financial year '26, '27. The FY '26 base revenue was INR 2,778 crores and we guide to a growth of 30% over covered market growth for the current financial year. We expect DBF EBITDA for the current year to come in at 37%, which is a similar level as the FY '26. We expect the H2 margin to be higher than H1. Moving on to the international business. As against a Q4 revenue plan of INR 115 crores, we ended the quarter at INR 86 crores. We were able to not ship out almost INR 30 crores of finished goods due to supply chain disruptions which resulted from a situation that we are well aware of. Versus a INR 375 crore targeted revenue for the year, we closed the year at INR 348 crores with a growth of 7%. Q4 EBITDA came in at INR 28 crores with a margin of 32.4%. And FY '26 EBITDA came in at INR 110 crores with a margin of 32%. We got the outcome of the EU-GMP inspection last month and we have a list of non-compliance observations which we need to remediate. These are largely procedural in nature, with minimal impact on the existing business. And remediation of these observations remains a priority for us. On the existing business, we are guiding to a revenue growth of 18% to 20% this year, with EBITDA margin at similar levels as FY '26 and the EU-CDMO products will get commercialized post the re-inspection and re-approval of the facilities. Moving on to the consolidated picture. Consol Q4 revenue growth came in at 7% and EBITDA growth at 8%. For the full year, the revenue growth came in at 8% and EBITDA growth at 10%. Let's look at these numbers in detail. Consol revenue for Q4 was INR 757 crores, and for the full year was INR 3,129 crores. Consol EBITDA for the full year was INR 1,120 crores. I'd like to call out a couple of things in particular. If we look at the core business, which excludes trade generics, which we discontinued in FY '26, and the low-margin DBF injectables, which we have spoken about before, FY '26 revenue growth came in at 10% and FY '26 EBITDA came in at INR 1,146 crores. So this is higher by INR 26 crores over a reported EBITDA of INR 1,120 crores. And this represents a year-on-year EBITDA growth of 13%, which is reflective of what is happening in the core business. The consolidated EBITDA margin also comes out to be 37.5%. Looking at the consolidated P&L for the year, I'll call out the highlights. The profit after tax from continuing operations came in at INR 132 crores in Q4, which is a 29% growth. And for the full year, came in at INR 498 crores, which is a 34% year-on-year growth. So this is the EPS acceleration which we spoke about earlier, where a 10% expansion in EBITDA gave us a 34% expansion in profit after tax. The reported PAT came in at INR 279 crores for the quarter and INR 648 crores for the full year. This is because of a one-off upside of INR 150 crores from a deferred tax adjustment. EPS from continuing operations came in at INR 36 in FY '26. The effective book tax rate for the year was 22%, excluding the DTL impact. It's down by 140 bps from last year. Finance cost for FY '26 was down 17% from last year. CapEx for the financial year came close to INR 300 crores, largely on biologics and sterile injectables. The closing net debt for the year was INR 2,255 crores, which is at 2x of EBITDA and down 2 turns over the last 2 years. OCF-to-EBITDA ratio came in at close to 50% for the financial year versus 105% for the last financial year. This brings us to the end of this presentation, and we can now open up for Q&A.

[Operator Instructions] The first question comes from the line of Kunal Randeria.

Sir, the DBF growth of 12% looks pretty solid, and in insulin also you have done pretty well, but it also indicates that the ex-insulin business growth would have been maybe around 8% to 9% only. Is my understanding correct? This is how will the growth shape up in the next couple of years also?

Kunal, can you say it again, please? I just missed you.

Sir, I meant, you see your Domestic Branded Formulations did pretty well, 12% growth. In insulin you seem to have been doing exceptionally well again. But it kind of indicates that your ex-insulin business, other than insulin, that business would have grown only around 8% to 9%. Is my understanding correct here? Is this how the growth will look in the next few years?

No, Kunal, I don't think. I think, when you see this data, the biggest drag on this data is OAD. So OAD growth has been a minimal, I think, 2%, 3%, 4%. Now OAD, we had a Glimisave that we banned last year, which was INR 30 crore for us, which internally is like 4.5%. So what will you see is that, that ban happened in the month of April last year, [indiscernible]. So by May, what will you see that the base correction would happen. So that is only one thing. But the way April, May is shaping up, we can tell you that, your logic might not be -- might not be correct. We are seeing a little bit of rebound in OAD, and then we are launching a couple of more products, the [ gSaxenda ] which I spoke about later. So I think ex-insulin double-digit growth is something which could be easily achieved.

Second comment maybe related to the first one is on semaglutide. Interesting comment you have made, diabetes seems to be the driver in the market. But can you tell us which current therapies or the line of treatment is it replacing? And do you think it can maybe pose a threat to the entire OAD space also? Maybe let's say instead of a DPP-4, doctors are now giving a GLP-1. So will it hit your DPP-4 possibly in future?

So Kunal, what you're saying is technically right. It's basic science that what GLP gives you is like 100 times of what DPP-4 gives you. So in the presence of GLP, DPP-4 doesn't really moves the needle. But look, DPP-4 is like a everyday, it's a first-line treatment for everyday diabetes. And GLP, we expect, I expect, say, 1.5 million patient by the end of the year, stable patient. So while what you're saying is correct, but out of the overall universe of diabetes patient, these 15 -- these 1.5 million patient is too less to really move the needle. But yes, there could be a slowdown in the growth rate. But please do not consider at this point of time that we will see any kind of a downturn in any OADs, not because of any technical reason, just because the denominator is going to be -- the denominator is very high and the number of patient we expect on GLP is not going to be that high in the first year comparatively.

Right, sir. Got it. And just one more financial question, if I can. Sir, receivables and inventory have gone up substantially, especially receivables from INR 450 crores to somewhere around INR 680 crores. So maybe care to shed some light on this?

I think inventory, large inventory has gone up because of our international business. That is where because of, early on, when we saw this disturbance, we piled up a lot of inventory in the international business. And because last quarter we could not ship it out, so it's showing up. We did a similar exercise for our domestic business also. We are ready to do some key APIs of ours were moving as much as 70%, 80% higher. We created a large inventory there. So that is inventory. The second is the revenue days. Now, revenue days is something which we need to correct, right? I think the [indiscernible] I think a good number for debtor days, more like 60 days and that is what we are aiming. I think within 2 quarter we should be up there.

I got that, sir. But why would it go up so much in one year from INR 458 crores to INR 680? I mean, there has to be some reason behind this, right?

Yes, reason is, Kunal. Yes, [indiscernible], you want to say something?

Yes. So Kunal, just to build on what Amit was saying, the strategic stock of A and then we had finished goods which we could not ship off. This is a significant magnitude.

I mean, there is no point in calling out these numbers, but we have taken like almost 9 months of inventory build up as far as RM and PM are concerned. So this is a considerable amount, and this was a conscious call. And later days also international business has really contributed, yes. Because we didn't collect much in quarter 4 because of all these disciplines. So Kunal, what we hear is because the dollar is moving here and there and it was delivered at a time when it was here. So there is a little bit of things which are going along, which are going, but my team tells me that the international piece will be fixed.

Yes, simple because, as of today, we are on 20th May, the international debtors are lower by 25% already. What you're seeing is a 31st March number, right? But I'm just talking about ongoing operations. So we've already started collecting this quarter, which is why Amit made that comment that in a couple of quarters we are confident that debtor days will come back to normal.

Sure, sir. As long as I mean, there is no risk of a bad debt, right? I mean, that's the takeaway.

No, no. Because that doesn't look like.

The next question comes from the line of Kunal Dhamesha.

This is Kunal from Macquarie Capital. Just one for Amit on the uptake of Sema and diabetes. Amit, what kind of trend are you witnessing? Is it used for the existing patients more, or let's say, the new patients which are being started on semaglutide? If it is existing patient, then I believe that the risk to the existing therapies would be much lower, right? Because existing therapies would continue for the same patient. So some color would be helpful. The second aspect of this question is, in terms of dose titration, how it works, how much time does it take for a patient to stabilize on a particular dose of semaglutide? That's my first question.

Look, I think the first month reflected, generics reflected at around INR 40 crore to INR 45 crore. There had been some number crunching which is being done that 50,000 to 1 lakh patients have been added. So I see a lot of enthusiasm, but it is a cautious enthusiasm, right? I feel that many people, many doctors are taking their own time. They would come on board in a while. Yes, we are seeing, look -- if you look at the usage, 70% of the patient on diabetes should require GLP as a -- from a guideline perspective, but we have just started. So the first level of patients which we are seeing are the patients who have diabetes uncontrolled and have a visible fat. So right now, if I tell you my own numbers, we have been looking into because our people services the patient. So we get an access. We can tell you BMI less than 30, the prescription is only 10%. So 90% of the even in diabetes is BMI more than 30. So that is where the starting point is. The second thing we see that BMI more than 30 and liver -- fatty liver, right? [indiscernible] so that is where it has started. And it's been 1 and 1.5 month, right? patients start with 0.25, and 0.25 is generally a warm-up kind of a thing. So in the next month onwards we will have patients coming back also. But Kunal, this is going to be, it's going to be a good therapy. It's going to be a breakout therapy. People who are using it are very happy. And patient resistance is still there because I think outside voice is- there is too much voice outside our ecosystem, which over a period of time will get little toned down. But -- so this is one. Now, what will it replace? Kunal, look, again, I'm sorry I'm repeating, but we expect 1 million to 1.5 million patient in the first year. So our diabetes denominator, this is a very small number. So I once again reiterate that we might not find any slowdown particular in any OADs, right? At least this year. If this therapy goes to 20%, 30% of diabetes, which it should go over a period of time, then we will see some slowdown in other OADs.

Sure. I'm in the same camp that it would not slow down OADs, but yes, let's see.

It looks like that. It's a good start, Kunal. It's a good start. Our brand has taken off well. We are number 1 in prescription also. And the good thing is we started with vials, and typically vials were a little, in today's time, general thinking is that it's a little difficult sell. But once again, it is people who have been selling insulin has come -- they have been the real change for us because we see doctors and patient needs a lot of support here, lot of hand-holding they need. And I think that is what is sticking out. And it seems that our brand name is also liked, which is a nice thing to know.

Second question on our FY '27 domestic formulation business guidance, growth guidance of around 1.3 times in covered market rate, right. So what are your assumption regarding the growth for our covered market for FY '27?

It has always been double-digit, Kunal. So I don't think anything changing there. And whatever Sema adds. Sema is a different story. But I think the covered market has always been double digit.

Sure. So basically then, at a console level, we should expect around mid-teens plus kind of top-line growth because export we are expecting a high teens growth, right?

Technically, yes.

And then for the EBITDA margin, I know we have been launching Sema and there will be launch expenses, et cetera. But do you see any upside to the profitability in FY '27, from what we have guided? Any drivers that you see which you are currently reluctant given all the geopolitical headwinds, et cetera. But any driver you can highlight?

Kunal, look, we feel the H1 would be a little bit of a drag on the gross margins because of all that we know. And especially Sema initially we have been talking about that would not be a very profitable thing. But in the H2, look, we have a lot of what we have missed is also because our Bhopal plant didn't start at time. And now that seems to be up close there. So once the vial SKUs are all already started, the benefit should start sooner. So for us, what will save us in terms of gross margins, even if the price relatively remain high, is the second half of Bhopal manufacturing and the incoming of Sundae, which is semaglutide. So I would not say that we can increase the margins. I would like that to be the way it is put up. But you will see an H1 being softer than an H2. That is what we assume.

[Operator Instructions] Next question comes from the line of Harith Ahamed.

Amit, sir, you touched on the Bhopal facility and the expectation around completion of the cartridge line there. So -- And if I heard correctly, we are expecting that to come online by the second half of 2027. So post that, can we expect a further ramp-up in our market share for Rh-insulin cartridges from the current [indiscernible]?

Harith, we are in a good space as far as the insulins are concerned, whether it is the cartridges, vials, or glargine. So you would see us ramping up all along, right? Even when we look at the April data, insulin GLP put together had a 35% growth, if I'm not wrong, in the IQVIA numbers. So this is -- the base was set last year, and now it will ramp up. So insulins, we have been quite confident, and that is how it will show up. So that's about the insulin. Also remember, last week, around 15 days back, we took the first engineering batch of bio-Sema in the Bhopal plant. So we received the PCT and we took the first batch, engineering batch. Then, we took a PV batch also. And this month end, we will be taking 2 more batches. One is degludec plain and the other is degludec [indiscernible]. So what happens, you will see a ramp-up happening in insulins from the tailwind of the last year, and then by the time we enter the next year, we will have 2 more big markets open for us. So strategically, our insulins and analogs and GLP piece is quite well settled, both from how they are today and how they -- and what kind of addition will happen into that basket. So all put together, insulin has been -- we are very happy with insulin, and we feel that we could be -- we could really ramp it up well.

Got it, sir. And then specifically on insulin aspart, you touched on some regulatory delays there. So I'm just wondering what exactly is the cause of this delay, because this is a US FDA approved product for our partner Biocon. And is this part of our expectation for FY '27? [indiscernible] on the analog insulin part, you touched on degludec. So degludec and lispro, I know these are for a bit later, but when can we expect these and do we have a partner for these products? Because as far as I understand, Biocon doesn't have these in their portfolio.

Harith, my friend, please understand, we have been doing the DS ourselves now. It's been 2 years we have been telling to you that we have our own DS setup level, which made the liraglutide, right? Which is now also is doing romiplostim, which is in Phase III already. We have 50% of Phase III patient also -- have already been done. So all these products, the entire degludec family and the recombinant Sema is coming from our own DS. And we are further investing and expanding the DS capacity. We have already put INR 150, INR 180 crores by this time. Sachin? So we have already put some INR 150 to 180 crores. [indiscernible] which you see also goes up there. So now we have a DS and a DP both line internally. So romiplostim, I told you, other than insulin, teriparatide is going into Phase III. So we've already got approval now for the Phase III trial. So we will start putting patients together. So the biotech, once again, I'm reiterating, and I'm sorry we were not able to communicate this well. Our Biocon platform, right from when we entered insulins has been in works. And today, if you look at our platform, we have 4 commercialized products and 4 products which are clear PCT are either in Phase I or in Phase III.

Got it, sir. And just to confirm, Aspart, both the plain as part as well as the premix, we can expect in FY...

Aspart is not there with us. Aspart has to be taken from outside. And there were some concerns regarding Aspart, not from the quality and regulatory, but there were some other concerns regarding Aspart that's why it gets delayed. So we are launching it in FY '27.

The next question comes from the line of Shashank Goyal. So there seems to be no response. We have the next question from Vinay Parekh.

Vinay Parekh from [indiscernible]. My question is regarding the EU-GMP inspection. Can you please deep dive in more details about the strategy and the remediation segment? Also, what will be the approx quantifiable impact in FY '27 in the EU CDMO product segment?

Yes. So answering the first question, we've already shared that most of the observations are procedural in nature. So they require remediation in terms of training and ensuring adherence to SOPs. Those initiatives are already underway in full swing. In fact, we've already had an audit from an important customer last week, and they are pretty satisfied with what is going on. So I would say that the remediation initiatives are well on way, and we should get there soon enough to a point where we can invite the agency for a second inspection. In terms of impact of the CDMO products, we had outlined to you last quarter that between the CDMO and the base business, we can look at a revenue of INR 550 crores to INR 600 crores. That's what we told you. And now we are guiding you to an 18% to 20% growth rate, which is coming only from the existing business. So the delta, which is to the tune of INR 120 crores to INR 140 crores, that is the CDMO component, which is pretty much intact, but it will go commercial once the facility gets reapproved.

The next question comes from Rahul Agrawal.

In terms of semaglutide, how has the market share trended in May in terms of prescriptions? You indicated a 22% prescription market share. Is that for pens and vials combined? Or -- and would you have a broad brush split there?

22% market share in prescription, pen and vials combined.

Yes. Yes, it's a pen and vial combined. Until this point of time, when we speak, that has actually gone up. In May, our market share has gone up in prescriptions.

Got it. And how is the split Amit, between pens versus vials broadly?

So pen -- look, vials we launched early on by the time the LOE was instituted. And pen it took some time for us to launch the pen. Pen was launched mid-April and then we have 1 SKU, so there was a little bit of a drag there. So right now, in my prescription, I'm reporting, let me just do a math, 170 and 140. So almost 60% coming from vials and 40% coming from pens. That's how the split is in prescription. And the units are a little more units, we expect units to be more like 50-50 or 60-40 in that zone.

Got it. That's helpful. And on the EU CDMO bit, just following up on the last participant's question. You mentioned that there was a customer audit last week and that kind of went well. So overall, in the long term, you guys had indicated a INR 800 crores to INR 1,000 crores EU CDMO opportunity. How do you see that being affected significantly because of these regulatory issues? And how have the discussions with the customers been? Is that just a postponement? Or do you expect meaningful impact there?

Yes. So valid concern and happy to report that there is no impact on that book. All the key items that were part of the book still continue to be part of the book. And the timeline impact is only in respect of this one product, which had to go commercial in quarter 1, which we are ready for and which is what is making this revenue in the current financial year. Barring that, we don't see any long-term impact.

Got it. And this facility that we had this impact for, I'm assuming is the old Swiss facility. And would we also be triggering a separate approval for the Eris facility that we had put up CapEx for? Or will this now all be part of the combined facility and has the same approval process?

So the EU inspection was conducted for the 2 injectable units, which are under Swiss Parenterals, right? And the Eris unit is oral solids and dermatology unit. So that unit did not get inspected in March. The only 2 units that got inspected were the 2 units of Swiss, which have been carrying EU approval since the year 2020.

Got it. Got it. Got it. And by when do you expect to trigger the reinspection and remediation CAGR on this?

So the trigger will be soon enough because we have to do the CAPA, which is the corrective action, preventive action plan and submit it to the agency, which I see happening soon enough. What we are unable to tell you though is when we can expect the agency to come back again because that is a matter of calendaring scheduling things.

The next question comes from the line of Tushar Manudhane.

Sir, just on this EU reinspection and the growth guidance, just a clarification again here, like 18% to 20% revenue growth guidance is considering CDMO, EU facility clearance and then incremental business from that or without that?

Without that.

And how much was that impact of this EU CDMO business, which has sort of postponed because of the reinspection?

As explained earlier, we had penciled in about INR 120 crores to INR 140 crores of revenue coming in from EU CDMO, which is the piece that has been postponed.

Just as a clarification, has the customer utilized maybe like a 2 supplier in terms of this so that, and which is why probably that business is lost or that business is postponed?

That business is postponed Tushar. It is not lost because fortunately for us, this product is in short supply in the target markets. So the customer is working alongside us to see how the remediation and how the reapproval can happen ASAP.

And is this the product which triggered this inspection or some other product triggered the inspection?

This was not triggered, Tushar. The 2 facilities have been approved since 2020, as we've been telling you in the past. EU comes for inspection every 2 years. The OSD facilities get a 3-year approval and injectable facilities get a 2-year approval. So this was part of the normal 2-year inspection cycle.

Understood. And sir, if you could also sort of break down the DBF growth therapy-wise maybe for FY '26 or for Q4 FY '26?

Tushar, you can find that in the data. But largely, I tell you the whole drag is coming from the OAD, which I explained. OADs was a very small 2%, 3% growth, and that is where the whole drag is coming. Other than that, insulin was right upfront there. Cardiology, we have caught up. It's like almost at the market now, quite a distance in the last year. Dermatology, we had been ahead. So the drag which you see is largely coming from OADs.

Got it. And sir, if you could share that you have already shared, let's say, one market share. If you could -- at least in the month of April, how much sales we made, just to get an idea in terms of what the industry size is. Maybe for the month of April.

Yes. So Tushar, April, our inflection was INR 4 crores, which is like more or less which we are there. So we started at INR 4 crores. And this is going to be a month-on-month buildup for the entire year. That's how this new market will unveil.

And the way this market has built up is that in line with -- or in terms of the industry size, for example, INR 30 crores a month approximately in April, effectively taking the market size, of course, it's scaling up, so can't annualize it. But do you think the industry is scaling up in line with your expectation?

Tushar, very early, very early. Just 2, 3 more months. We -- look, patient onboarding is not bad, right? But these are all numbers which we divide and these are assumptions which we make. A lot of stuff sits in the shelf also. So I don't really believe that number of 1.5 lakhs, 2 lakhs. What we can tell you in the HealthX data, which covers a small part of the number -- a decent part of the doctors, that reports around 25,000 to 27,000 patients, right? Real data monthly. So 25,000 monthly from HealthX cohort is not -- is a good start. But the large physician community is still not kind of -- it's still not there. And that happens every time there's a new drug, there's a new molecule, which is launched. But this will be a good market, Tushar. We have -- we are quite confident, and it's a very good drug also.

And sir, this INR 4 crore in April by your judgment, what that number is in the month of May?

Sorry, what was that?

INR 4 crores in April, how much in May.

Yes. So we expect around 20% movement between April and May. 4 to 5 on a secondary basis.

[Operator Instructions] Next, we have a follow-up question from Kunal Dhamesha.

Just on the sema generic market, as the competitive intensity which you are witnessing is in line with what you had expected? Or is it better? And then what is the impact on potential pricing in that market, let's say, 1 year forward, do we expect prices to start increasing from here? Or do we still see that there will be continuous pressure on keeping our prices very affordable in this segment?

So Kunal, look, contrary to what everybody thought, the competition is not very fragmented here. We don't see -- as we read in a lot of reports, media 100 people, 50 people. But because this is a little bit of a complex selling, I don't find this going to that level. I think this is the -- this is the brand where very initially, you will see the top 5, top 6 gaining 65%, 70%, 75% market share. And I don't think that would change in the near future also because of the supply chain, because of the complexity and all those things. So contrary to what was written all over, I believe that this is going to be a 5-, 6-player game. And you will see a 13% to 15% market share person being there as #1. So this is what it looks like today. Now price. Look, prices going up in India is something which I haven't kind of seen. We only talk about prices going down and then do we make a profitable -- will it be a profitable sale. So we actually priced our product 30% lower than most of the companies. Generally, if you look at largely everybody is INR 4,200 plus for a [ 2-milligram ], we are at INR 3,200 plus. So we have already taken a little bit of a price cut because we feel that this might be a little more sustainable. So instead of price hikes, I would see some price correction happening over the next year and then it gets stable.

Sure, sure. And then let's say, once our capacity kicks in for pens, et cetera, right, do you see that once scaled up, this could be as good as a profit generator as our current business?

At an EBITDA level, there is a good possibility. At a gross margin level, no. So will we ever see it getting to 80% gross margin? I don't think ever. But can that be -- because it will be not as competitive, can it give us the same EBITDA? I am hopeful for that.

Okay. Sure. And then on the European -- this -- the entire plant issue, generally, I have not seen any company struggling with the EU-GMP, right? So what is it that they found out even if those were procedural. My view is that EU-GMP is generally very -- they are very open to dialogue and understanding your perspective, right? So what actually transpired in a way that we are basically left with the issue. And while we continue to say it's procedural, but it would be great if you could highlight a couple of key observations that they have highlighted and what's the corrective plan? Have we kind of employed any consultancy agency to kind of carry out that plan? And will it require some form of infrastructure changes in the plant or maybe a shutdown of particular lines to carry out remediation plan? Those details would be helpful.

So Kunal, when we told you it's all procedural, right? And KK will kind of enhance that. What I remember seeing that there is no QA, no QC, no data integrity issue. Now what I remember reading is the flow of people movement, right? The SOPs for the movement, especially around the microbial product, the antimicrobials. So largely in that zone. So we have discussed this, so I can tell you that we do not expect any CapEx for [indiscernible]. It is more about procedural. So agency hiring, training is already done. So that is what I know, KK, if I'm missing on something, please.

Yes. I mean that sums up the situation very well. And since you wanted a little more color, Kunal, a, I beg to defer when you said that you started off saying EU usually doesn't disqualify facilities because there is enough press out there in terms of larger companies who are also facing similar issues. But be that as it may. In our situation, we are not looking at any CapEx. I'll be very clear about that. So we are not looking at shutting down any line. We don't have the liberty of shutting down any line. All lines are operating in full swing, right? The situation that we are dealing with right now is the ability to ship product to the EU. So our customers in the existing markets are still being serviced from those very lines. So there is no question of any shutdowns being taken. So the plant is in operation as usual. Alongside, we are investing time and effort in, a, in some cases where, for example, this is not a classified area, but they want it to be a classified area. That is one example of an observation, [indiscernible] of the observations are on operator behavior, simple things like they are standing too close to each other. They're not behaving in a sterile area in the way they are supposed to behave. So that has to be addressed through training. And in the couple of cases where we do have to install some hardware, we are talking of stuff like pass boxes, to be honest, for RM dispensing. So that is the level at which the events are. So it is not something that is any cause of concern, neither for us nor for.

Sure, sure. And lastly, the way I understand for our EBITDA margin guidance for FY '27 is more or less would be in the similar lines to FY '26. Is it the correct way to understand and H1 being lower than H2, right?

Yes, Kunal, 37% DBF and 36% consolidated. We are guiding for the same '27.

Even if there is no equity attached to that, still we maintain 36%, 37% margin.

The next question comes from the line of Bharat Shah.

This is Bharat Shah from BCS Capital Ideas Limited. So my first question is about overall capital efficiency and the capital intensity of the business. So this is not for this quarter or this year. But when I see it over the period of time, let us see if I think about last 4 years, our turnover, which was 4 years back, a little less than INR 1,700 crores, about INR 1,685-odd crores, has now touched about a little over INR 3,100 crores. And the capital employed in terms of the net worth and only debt including, I'm not including any other form of liability. But net worth and the debt, which was INR 3,100 crores in the current year, I don't have the final figures of the net worth and all that. But on a ballpark basis, the total of net worth and debt would be INR 5,600 crores. And throughout this period, almost the capital behind capital deployed of net worth and debt is a little less than 2x the turnover. Therefore, my question is about capital efficiency. While your margins are healthy at 36%, 37%, but those kind of margins cannot forever be assumed at least, even if it is maintained. And if I -- net of depreciation, if I see, depreciation and amortization about 28-odd-percent margins. That means if the capital takes 2x the turn -- I mean, 2x the capital of the turnover, then I'm forever stuck in 14%, 15% return on capital employed bracket. Is that a realistic way to describe the business? Or this is current situation, but hopefully, it will improve?

It is current situation. Our return on capital employed for the year was at 15% and adjusted return on capital, which is excluding the impact of M&A-related amortization is 20%. So that is where the FY '26 numbers stand. And as we have called out a number of times, this is a transient phenomenon because in financial year '25, we took the impact of the highest ever amortization. Our asset base increased by 6x, as you have correctly pointed out, in a very short span of time. But the gains from this expansion have started coming in from FY '26 onwards. So the EPS acceleration is the first thing that you see come through where for a 10% growth in EBITDA, you saw 35% growth in EPS, which will be sustained. In the next 3 years, so over an FY '26 to FY '28 period, we expect the return on capital employed to go from 15% to somewhere in the 23% to 25% range, which is what we have called out and which is what we expect to happen.

But also [indiscernible] capital expenditure?

The capital base.

So also there is something which we have been doing since the last 3, 4 years because we decided to move up into a little bit of a complex manufacturing, a little bit tech-based manufacturing. And these things generally have a time gestation time of between 3 to 4 years. So if you look at our investment thesis, and I'm not talking about acquisition and amortization, I'm talking about the capital which we are employing in hard assets. So if you look at how we have been thinking through it that we have been putting money in a very strategic manner from our side, that is to develop a large biotech play. And for that biotech play itself, we would have invested around INR 160 crores, INR 180 crores on our DS and another Bhopal INR 250 crores. So INR 250 crores in Bhopal, which is a fill and finish site, which has a very large capacity once it is approved and done. Now nothing has started coming out from both of these. So Bharat bhai, we feel that once our Bhopal is ready, it will be one of its kind from a scale perspective. And that will give us a very good kick up in margins and will open up a lot of new markets for us, including new products. And we also have made a map facility there, which we think is the future. But we have been delayed by almost 1 year or 1.5 years by putting this together. So our expenditure has been very strategic in nature. And the second big expenditure which we have put is in another plant for Swiss Parenterals, which should be completed by this month.

Looking at commissioning in April.

Commissioning in April, which will be 2x of what current capacities are. So then what happens, the parenterals capacity increase is 2x and the biotech capacity is like [ 80 million ] and similar vials and then lyophilize and the other thing. So once this is commissioned, and Bharat bhai we also see a lot of traction when it comes to insulin, not only for India, but also shipping them outside once the regulatory things are in place. So that has been the direction of our capital allocation.

Right. No, I appreciate that. I definitely believe that the direction which we take and what we choose to buy into is quite strategic. That reflects in the kind of strong margins that you always earn. But ultimately, margin is only one part of the capital efficiency. Ultimately, how much capital is turned over also has a very deep impact on the capital efficiency. And in your case, while hard assets behind biotech and all that, maybe INR 170 crores, INR 180 crores, but acquisition of the brand or the intangibles is the real large asset play that you have got into because that's where the amortization comes by. So I -- while Krishnakumar mentioned that without amortization, return on capital employed is higher. But I would respectfully submit that we can't do that because the amortization stems from intangible assets that we have acquired and the benefit of that is reflected in the turnover and profits. And therefore, amortization is very much like any other hard asset that is there. So KK, just to be clear, that 15% ROCE after charging amortization is what you expect to climb to 23% to 25% in 3 years, right?

Yes. That is what I meant. I take your point that adjusted ROCE is one thing. The accounting ROCE is 15% as is the return on equity. And this is a number that we expect to get to 23% to 25% once everything starts firing the way we expect it to.

Yes, because the point about accelerated EPS is well taken, but accelerated EPS is a function of operating leverage and financial leverage. So I'm not really going into that. The core capital efficiency is critical to drive long-term sustainable capability to invest and grow the business. It was from that perspective, I will say it.

[indiscernible].

Sure. And just one last question, a quick one. What will be the ETR, KK in the current year in '26, '27?

Sir, it is 21% for this year.

Effective tax rate.

Up to 21%. For the '26, '27, right?

FY '26, it is 21% -- 22%.

For FY '26, the effective book tax rate was 22%. It's also part of the presentation. And we expect this to be 21% zone for financial year '27.

The last question comes from Mr. Mohamed Patel.

I hope I'm audible.

Yes. You are.

This is Mohamed Patel from Edelweiss Public Alternatives. So I have a few questions on international business. I want...

Mr. Mohamed, you're not audible.

International business...

Mohamed we can't hear you very clearly. I request you to take this offline with me.

Am I audible now?

Yes, you're audible.

I'm asking what's the geographical mix for the International Business for FY '26?

So our geographic mix has been quite stable in the last 2 years. We typically get about 30% from Africa, about 30% from Asia, about 25% from LatAm and the rest of it is all dispersed. So this year, we expect the LatAm component to grow faster because there are a lot more new product approvals. But broadly, these 3 will continue to be our key geographies.

Okay. And you talked about supply chain disruption in Q4 for the international business. Is it going to impact H1 also?

We don't expect it to be of a similar magnitude. I think we are all following the same press. So unless we have any difference of information, Q4 was way worse than what it is looking like today. So we are hoping that we'll be able to recoup at least some of that in Q1.

April was...

It's better than -- it's way better than what was in March. So...

Okay. And on the EU CDMO, should we expect some revenues in FY '27? Or we should expect major revenues in FY '28 in base case?

So in base case, I mean, your guess is as good as mine. We are -- I'm not counting any revenue there, which is why we've given a guidance of 18% to 20% growth. So anything that comes from EU CDMO, let's take it as an upside.

Okay. One last question on the DBF business. So if I go therapy by therapy, do we expect to outperform majority of our therapy by therapy in FY '27?

Today, I mean, Amit already spoke in detail about the 4 major therapies, which is insulins, cardiovascular, derma and OAD. So insulins and derma are already outperforming, and that's expected to continue. [ CPD ], we have caught up on a quarter-on-quarter basis. So by quarter 4, we are almost on par with the covered market. And with some good product launches like VzaxirrenO, we expect that should fire well. So that leaves the OAD piece where we'll need a little more bit of time to catch up.

Due to time constraints, that would be the last question for the day. I would now like to hand over the conference to Mr. V. Krishnakumar for closing comments. Over to you, sir.

Nothing from our side. Thank you for being here. And if there's anything left out because we're running out of time, Kruti and KK will take it off right. Thank you so much.

Thank you very much, sir, and thank you, members of the management. Ladies and gentlemen, on behalf of Eris Lifesciences Limited, that concludes this conference. Thank you for joining us, and you may now exit the meeting.