Hikal Limited (524735) Earnings Call Transcript & Summary

August 7, 2025

BSE IN Health Care Pharmaceuticals earnings 67 min

Earnings Call Speaker Segments

Operator

operator
#1

Ladies and gentlemen, good day, and welcome to the Q1 FY '26 Earnings Conference Call of Hikal Limited. This conference call may contain forward-looking statements about the company, which are based on the beliefs, opinions and expectations of the company as on date of this call. These statements are not the guarantees of future performance and involve risks and uncertainties that are difficult to predict. [Operator Instructions] With this, I now hand the conference over to Mr. Sameer Hiremath, Managing Director from Hikal Limited. Thank you, and over to you, sir.

Sameer Hiremath

executive
#2

Thank you. Ladies and gentlemen, good afternoon, and a warm welcome to all of you. I extend your gratitude to all of you for participating in our Q1 FY '26 results conference call. We are pleased to provide you with an update on the progress made by our company. We trust that you have had the opportunity to review our comprehensive earnings release, investor presentation and the financial statements for the quarter ended 30th June 2025. These documents can be accessed on both Hikal's official website and the stock exchanges website. I am Sameer Hiremath, Vice Chairman and Managing Director of Hikal Limited, and I'll be leading the discussion and presenting the financial results. On this call with me, I have Anish Swadi, our Senior President and Head of Business Transformation; Kuldeep Jain, our Chief Financial Officer; Manoj Mehrotra, our President, Pharmaceutical Business; Vimal Kulshrestha, our President, Crop Protection business; and Strategic Growth Advisors, our Investor Relations advisers. Q1 FY '26 marks the continuation of the challenging industry environment, characterized by global overcapacity, intensified price pressures and demand volatility across core markets. The chemical and life science sector continues to experience uneven recovery with pricing compression in select geographies, especially from Chinese competition. Tariff shifts and procurement variations due to trade realignments further complicated the external landscape leading to a muted first quarter. In this quarter, Hikal reported consolidated revenue of INR 380 crores and EBITDA of INR 25 crores. Our consolidated performance was impacted primarily due to the deferment of shipments in our pharmaceutical business. Our Pharmaceutical business saw 11.7% revenue degrowth on a year-on-year basis on account of delayed offtake from key anchor customers. During the quarter, the U.S. FDA issued an official action indicated OAI status to our Bangalore facility following the inspection in February 2025. We want to assure all stakeholders that Hikal has taken this matter seriously and has already implemented comprehensive corrective and preventive actions in line with the agency's observations. These observations were procedural in nature and did not include any issues on data integrity. We have submitted a detailed response update outlining these actions and remain in active communication with the U.S. FDA. We are working diligently to ensure full compliance and alignment with all regulatory expectations. We continue to uphold the highest standards of quality and remain committed to strengthening our regulatory systems and culture. We did have some positive news during the quarter. GMP audits at our Bangalore API facility by 2 global regulatory authorities, EnVSa in Brazil and PMDA in Japan were successfully concluded. This reinforces our regulatory credentials and positions us well for future growth in key Latin America and Japanese markets. This is in line with our current strategy to derisk our market concentration in view of the uncertainty in the ongoing tariffs. In the CDMO segment, the pipeline remains healthy, and we are engaged in multiple projects with global innovator customers. Most of these are in the early to mid-development stages. Commercial revenues is expected to happen towards the end of this financial year. The Crop Protection business continued to maintain a stable trajectory, largely driven by sporadic global demand in specific segments and while having persistent pricing erosion from oversupplied markets. Revenue remained largely flat on a year-on-year basis. Despite this, we maintained operational efficiency through tighter cost controls and process optimization. We anticipate a gradual volume recovery in the second half of the year as seasonal demand picks up across global agrochemical markets. In summary, while Q1 FY '26 reflects a slow start and a negative start to the financial year, we remain confident of delivering on our yearly guidance, which we spoke about in the last investor call. We expect performance to improve meaningfully in the second half of the financial year with Q4 being the strongest quarter of the year, led by enhanced plant utilization, increased offtakes and new product commercialization. Now, I will hand over to Kuldeep Jain, our CFO, who will provide an overview of the financial performance.

Kuldeep Jain

executive
#3

Thanks, Sameer, and good afternoon, everybody. Let me now walk all of you through the financial performance of Hikal for the quarter 1 FY 2026 and share key updates on our financial trajectory, capital allocation priorities and balance sheet strengthen. For Q1 2026, our consolidated revenue stood at INR 350 crores compared to INR 407 crores in the corresponding quarter of the last year. This reflects the impact of continued softness in select product categories and deferred offtake from key anchor customers, particularly in the Pharmaceutical division, partially offset by stable performance of our crop protection. EBITDA stood at INR 25 crores with an EBITDA margin of 6.5% as against 14.3% in Q1 FY 2025. The margin compression was largely driven by under absorption of fixed costs, less favorable product mix and lower capacity utilization in a few manufacturing blocks on account of scheduled maintenance shutdowns. Depreciation and finance costs for the quarter were INR 39 crores and INR 17 crores, respectively. The cash profit for the quarter stands at INR 16 crores. During the quarter, we improved our working capital utilization, resulting into a positive free cash flow of INR 15 crores. Our CapEx for Q1 FY 2026 was INR 31 crores, primarily towards the debottlenecking, regulatory upgrades and CDMO capacity augmentation. We are maintaining our full year CapEx guidance of INR 200 crores and remain disciplined in allocating capital towards high ROI projects aligned with our long-term growth strategy. Our debt equity ratio remains stable at 0.54. Our balance sheet and cash flow remain strong. Now I would like to hand over to Vimal, who will provide an overview of Crop Protection division performance. Over to you, Vimal.

Vimal Kulshrestha

executive
#4

Thank you, Kuldeep. Good afternoon to all the participants of this earnings call. The global crop protection industry continued to face uneven recovery in Q1 FY '26. This is led by persistent overcapacity and aggressive price competition from China. Despite these market challenges, we at Hikal have remained focused on disciplined execution, prioritizing operational efficiency, product mix optimization and strategic customer engagements. During the quarter, our Crop Protection revenue stood at INR 178 crores with EBIT at INR 17 crores, largely flat on a year-on-year basis. Margin remained under pressure as pricing pressure continues due to oversupply in the global system. The performance is expected to remain stable during the year on an annual basis. Adding to the industry level pressures, global innovator customers in the Crop Protection segments are undergoing significant strategic shifts. This includes portfolio realignment, business segment restructuring and the pivot towards next-generation innovation platforms. This alignment is influencing procurement patterns, contract time lines and in some cases, impacting commercial decisions across the value chain. While this presents near-term volatility, it also opens up longer-term opportunities for differentiated partnerships, co-development programs and supply chain localization. In addition to crop protection, we are also making measured progress in personal care and specialty chemical space. In line with our broader diversification strategy, during the quarter, we continued to deepen engagement with global customers for innovation-driven cosmetic and personal care ingredients, supported by our capabilities in complex chemistries and sustainable manufacturing. The response has been encouraging from customers with early success as we have received multiple RFPs. This segment remains an emerging growth lever, and we are focused on building a differentiated product portfolio aligned with evolving customer and regulatory expectations. Accordingly, we have intensified engagement with strategic accounts, realigning our technology pipeline to reflect customer prioritization and focused R&D efforts on developmental molecules that align with innovation-led demand. We continue to maintain a healthy development pipeline of 8 projects. Our R&D team continue to play a pivotal role in accelerating these projects and delivering with innovation. In terms of cost control, we have implemented several initiatives across procurement, energy optimization and yield improvements, helping us protect contribution margin with an aggressive pricing -- in an aggressive pricing environment. In summary, while near-term market dynamics remain fluid, our fundamentals in Crop Protection business remain intact. We are confident that the strategic choices we are making today, both in terms of portfolio and operational excellence will enable us to deliver profitable, sustainable growth as the industry rebalances. Now I would like to hand over to Manoj, who will provide an overview of Pharmaceutical division performance. Over to you, Manoj.

Manoj Mehrotra

executive
#5

Thank you, Vimal, and good afternoon, ladies and gentlemen. Let me now walk you through the performance of our Pharmaceutical division for quarter one FY '26. During the quarter, the Pharmaceuticals segment recorded revenue of INR 203 crores and EBIT loss of INR 27 crores. Customer offtake patterns were impacted in part due to the recent U.S. FDA OAI status at our Bangalore facility. This has led to a degree of volume deferral from the first half to the second half of the fiscal year. Margin realization was impacted by lower volumes and changed production mix. Our profitability was affected by lower operating leverage. However, based on our current visibility and the pace of engagement with customers, we do not anticipate an impact on overall revenue and margin performance for FY '26. Now I would like to give an update on our regulatory compliance. A major milestone this quarter was the successful completion of [indiscernible] audits at our Bangalore facility by 2 global regulatory agencies, ENVISA. Brazil and PMDA Japan. This reaffirms our regulatory credibility and significantly enhances our access to key Latin America markets and the strategic Japanese market. I would like to reaffirm our unwavering commitment to compliance and quality excellence, as Sameer mentioned earlier. The OAI status received by our facility post the U.S. FDA inspection is being addressed through a structured time-bound remediation program. We are working closely with regulatory experts to ensure that the corrective and preventive action, which is CAPA, meet the highest standards of global regulatory expectations. We have till date completed majority of the corrective actions, and we expect the remaining balance to be closed out before end of this quarter. We have kept the U.S. FDA appraised of the progress on a regular basis. For our API business, we demonstrated volume degrowth on a Y-on-Y basis, driven by shift in offtake patterns from anchor customers and product mix. We have seen particular traction in certain markets where our long-standing portfolio is complemented by growing market share in select molecules. Our product development pipeline remains strong with 8 to 9 molecules currently under development, and we remain on track to launch 2 to 3 new products annually in line with our medium-term road map. As part of our risk mitigation strategy, we are progressing towards dual-site validation for all our critical APIs. Our CDMO business continues to benefit from the structural momentum driven by the China Plus One strategy, which is reshaping the global outsourcing landscape. We are observing a sharp uptake in our early-stage RFPs, particularly in high-value small molecule and advanced intermediates. This demand is being driven by global innovators and emerging biotech firms who are looking to diversify their development and manufacturing away from single region dependencies. While commercial scale-up time lines remain staggered, the volume and quality of engagements have significantly improved. We are currently working on various CDMO projects, of which a few are transitioning from early development into pilot scale. In the food and nutraceutical ingredients, we are on track to gain scale and expect it to reach peak output over the next 18 to 24 months. We are working towards further expanding our product portfolio in this segment. Our initiatives in this segment are progressing well. Separately, the key starting materials being manufactured for global innovators have advanced into Phase III clinical trials, and we expect this to translate into commercial launch by FY '27. To support this momentum, we are investing in enhancing pilot scale capacities and dedicated project management teams for CDMO clients. These enablers will allow us to better serve early-stage programs and establish ourselves as a long-term strategic partner. On the overall pharma business outlook, the API volumes are expected to improve, supported by regulatory approvals coming through across geographies and increased penetration in semi-regulated markets. In CDMO, while near-term visibility remains tight, the pipeline is robust and diversified with engagements growing in both volume and technical complexity. We have completed several customer orders during this quarter. Our near-term focus remains on improving contribution margins through cost productivity, scaling differentiated API projects in both segments, strengthening customer partnerships to compliance, quality and responsiveness as well as enhancing regulatory readiness for new markets and molecules. Now I would hand over to Anish, who will provide an overview of our business strategy.

Anish Swadi

executive
#6

Thanks, Manoj, and good afternoon, ladies and gentlemen. First, I'd like to discuss our Animal Health business. Our Animal Health business continues to make steady strides both operationally and strategically. Under our long-term supply agreement with a global animal health innovator, the development and validation of the APIs -- API portfolio is progressing as planned. Several more products are currently in the validation pipeline and commercial filings are underway for multiple markets. We expect commercial launches in FY '26 and beyond. We are also taking a step further with 2 complex chemistry molecules that are moving to the development phase. Our relationships with several global innovators spread across the U.S. and Europe in the Animal Health segment have been built over the last several years based on reliable delivery, technical collaboration, which continues to strengthen further. We are increasingly positioned beyond just a manufacturing partner driven by innovation and our proven track record in complex synthesis, compliance and agility in process development. We are now focusing on expanding our footprint with Tier 2 innovator customers, the biotech segment and the own product portfolio focused on several key geographies. This will further provide diversification to the Animal Health business and act as one of the key growth levers in the long run. Turning to our Project Pinnacle, which is our enterprise-wide transformation initiative. We continue to make disciplined progress in reorienting Hikal for the long-term sustainable value creation. Well into its execution phase, the program is delivering measurable outcomes across critical levers, including supply chain resilience, digital modernization, operational excellence and ESG integration. A core pillar of our strategy under Project Pinnacle is the diversification of our businesses across multiple dimensions, spanning end markets, customer segments, geographies and product portfolios. We are actively expanding our footprint in high-growth regions such as Latin America, among others, and increasing our presence in differentiated chemistries and deepening our participation in adjacent verticals such as the Animal Health business and specialty chemicals. This multipronged diversification approach is designed to structurally derisk the business by reducing reliance on any single market or segment while enhancing our ability to navigate external volatility whether regulatory, geopolitical such as tariffs or macroeconomic. Project Pinnacle is central to our ambition of building Hikal into a more resilient, innovation-led and globally competitive platform, well positioned to capitalize on emerging opportunities across the life sciences value chain. In summary, although we have hit a slight hurdle in our Pharmaceutical business, it is expected to recover in the second half of the year. Global prospects for all our businesses remain strong. We remain optimistic about the road ahead. We have focused initiatives on reducing costs and streamlining operational efficiency. Our geographic and product diversification is reducing concentration risk and reinforcing our ability to navigate global headwinds. Now I would like to open the floor to Q&A.

Operator

operator
#7

[Operator Instructions] The first question comes from the line of Dhrumil Vani from [indiscernible] Capital.

Unknown Analyst

analyst
#8

So a couple of questions. So first on the agrochemical. Recently, there are some media reports suggesting some increase in the prices of the agrochemical by Chinese supplier and also the Chinese policy of not operating at such lower margins across various industries. Do you -- with this in mind, do you see any positivity and would like to change your outlook for the year, which you had -- -- so last quarter, you had a flattish growth outlook for agrochem. But given this scenario, for example, [indiscernible] prices has been increased and a couple of other molecules also. So any comment on that? And on pharmaceutical, it has mentioned in the press release that there has been some deferment of orders -- the lifting of the orders by clients in CDMO and API division. So -- and you expect recovery in Q2 and then going forward. So what are the actions the customers are taking? Are they sending their team to check the plant and be satisfied? And by when and how will they increase the offtake? And also what is the deadline for us to submit the report to the U.S. FDA? I think in last conversation was some September, October. But if you can just revisit the deadline that by which as investors, can we find that beyond this, there would not be any negative surprises coming. These are my 2 questions.

Sameer Hiremath

executive
#9

Sure. So I'll let Vimal take the crop section and Manoj can answer the pharma part.

Vimal Kulshrestha

executive
#10

Yes. So in China, though -- I mean, there are news that some products slight price increase is there. But by and large, prices are flat. And we -- based on that, we anticipate a flattish revenue growth for the Crop Protection division.

Unknown Analyst

analyst
#11

Okay. And what about the inventory situation at the end client level? Is that easing off because the numbers what the other companies are reporting are good so far.

Vimal Kulshrestha

executive
#12

So in some pockets, it is improving. In some pockets, still customers are holding high inventories. And they expect to rationalize inventory in the second half of this year.

Unknown Analyst

analyst
#13

And what's the exposure to Brazil?

Vimal Kulshrestha

executive
#14

Sorry?

Unknown Analyst

analyst
#15

What is the exposure to the Brazilian market?

Vimal Kulshrestha

executive
#16

For us, I mean, it is not very high. It's...

Unknown Analyst

analyst
#17

Understood, yes. And the pharma bit?

Manoj Mehrotra

executive
#18

Yes. On the pharma part, we received the OAI status from U.S. FDA towards the end of May. So that does mean that the customers do their own risk assessment. So many of them did it virtually. Some of them decided to come over to Bangalore and see for themselves. So that process takes around 6 to 8 weeks, and most of our customers have completed that their own risk assessment. And they have found that everything is in order, whatever corrective actions we are taking. It does not give any risk to their products. The shipments have restarted now. And over the next 2 quarters, we'll be able to cover up the setback what we had in Q1. Coming to the corrective action, we have corrected almost 75% to 80% of the CAPA, which we have taken in our first response, followed by the updated response. By end of September, we'll be finishing all our corrective actions. And we are in regular touch with U.S. FDA and giving them a monthly progress update. The last one was given as recent as July 31, which is just a week back. We hope to hear from them by end of August on our responses.

Unknown Analyst

analyst
#19

Okay. And the entire cost of these corrective measures, has it been expensed completely on the P&L in this quarter?

Manoj Mehrotra

executive
#20

Many of it is a little ongoing. That is on facility upgradation and quality control upgradation. So that is ongoing and there is some bit of capital expense, not much of P&L impact.

Unknown Analyst

analyst
#21

Okay. So there's no P&L impact of this -- because I think in last conversation, there was INR 10 crores, INR 12 crores.

Sameer Hiremath

executive
#22

Let me introduce -- let me. We have hired these consultants so that we expect INR 10 crores to INR 12 crore impact for this year, almost 50% has come in, in the first quarter. And we expect it to continue for Q2 and Q3 as well.

Unknown Analyst

analyst
#23

Okay. So that -- so around INR 5 crores is on the P&L?

Sameer Hiremath

executive
#24

For this quarter, that's right.

Unknown Analyst

analyst
#25

Yes, its expense from the P&L.

Sameer Hiremath

executive
#26

That's right. In the other expenses, yes.

Unknown Analyst

analyst
#27

In the other expenses. Okay. Okay. So this year-over-year fall of around INR 20 crores, INR 23 crores in our pharma business. So this gap is of this low uptake and the growth also has been postponed, right? That's the bridge, right, the revenue bridge?

Manoj Mehrotra

executive
#28

Yes, shipments have been deferred. Shipments have been deferred. So that will be recovered in the next 2 quarters.

Unknown Analyst

analyst
#29

Okay. Okay. So they would be adjusting the inventory at the customer end by purchasing it from some other customer or they have a buffer and they can -- they are okay with this [indiscernible].

Manoj Mehrotra

executive
#30

Most of them have a buffer. The big ones have a buffer. So no orders have been canceled for us due to this.

Unknown Analyst

analyst
#31

Okay. Okay. Okay. So -- and can you reiterate your guidance for the year? What was it?

Sameer Hiremath

executive
#32

We had given it last time, it was -- Crop Protection was flat and Pharma, we expected low teens growth.

Manoj Mehrotra

executive
#33

Yes, 12% to 14%, right?

Sameer Hiremath

executive
#34

12% to 14%. Revenue growth, yes.

Unknown Analyst

analyst
#35

And margins.

Sameer Hiremath

executive
#36

Margins -- EBITDA in margins will improve slightly more or less in the Pharma business. Crop will be about flattish.

Operator

operator
#37

[Operator Instructions] The next question comes from the line of Venil Bagadia from Equicorp.

Unknown Analyst

analyst
#38

Sir, some clarification based on the previous participant. Sir, what is the revenue loss that we see due to the deferment of orders? And once you said that the orders are fine and the shipments have started, so we haven't taken any onetime inventory markdowns due to any quality or any possible suspect from the end of customers, right?

Sameer Hiremath

executive
#39

No. [indiscernible] nothing wrong.

Unknown Analyst

analyst
#40

And what would be the -- I mean, the revenue loss because -- I mean, there has been a...

Sameer Hiremath

executive
#41

Yes, I'll take that. So revenue -- it's not a revenue loss, it's a revenue deferment, which is about INR 50-odd crores in the first quarter, which is getting deferred to Q2 and Q3.

Unknown Analyst

analyst
#42

Okay, sir. Sir, I actually had a question related to the plant -- animal plant -- animal health plant. So we have commercialized the plant in FY '24, I guess, the third quarter of FY '24. So usually, the pharma and chemical industries, I mean, the sooner we commercialize the plant, the better it is. And usually, people have 3, 4 or max to max or a 5-year cycle to which they actually get to optimum utilization for good paybacks and IRR and returns. So we have not commercialized it in -- I mean, it's almost 2 years and we have not commercialized it still, and we are still waiting for more validation. So I mean, when do we actually expect the commercial runs? And how has been the returns since we have not commercialized for the next 2 years? And also, is that -- how do you see the situation on the spec chem plant that you just recently capitalized? I mean what kind of payback you see there? How fast you want to commercialize and get into actually commercial batch orders and ramp up the digitalization?

Anish Swadi

executive
#43

Yes. So I'll take the first stab. When we say commercialize the plant, we had a portfolio of products. So when we started in late FY '24, we started with validating a few products and all through this last 12, 14 months, we've been validating the products. Once the first original products have been validated, now they're going through commercialization. So it's not correct to say that the plant is not commercialized. It's not for a single product. As we finish the last validation that we have coming up in the next quarter, all products will be validated through the plant and commercial quantities will thereafter start between 12 to 14 months post validation. So we are supplying small commercial quantities already for the products that we had validated originally in late 2024, right?

Unknown Analyst

analyst
#44

So that test batch quantities. That will be test batch quantities and it won't be a significant part of the revenue, right?

Anish Swadi

executive
#45

No, they're starting out small where they change -- basically, they have some inventory on hand from their original suppliers. So that inventory, they're going to stop. And then from 20:80, it's going to become 80% us and 20% the second source supplier.

Unknown Analyst

analyst
#46

Okay.

Anish Swadi

executive
#47

And your second question regarding the specialty chemicals. So what we've done is basically the growth rate that we see in pharma is surpassing that what we see currently in the crop protection business. So what we've done is we've taken that spec chem plant and we've converted partly into pharma and animal health for future business that we have backed by contracts. So we expect that currently, what we're doing is we are undergoing some reffitment in terms of equipment, clean rooms, closing out some of the plant. And we expect that in the next 6 to 9 months, we'll be able to start commercial production, at least validation and then commercial production for some of these products.

Unknown Analyst

analyst
#48

So just a clarification, sir, when you said you're converting some part of the spec chem plant to pharma use, so what will be our investment that we would be doing in terms of clean room and additional some reactors or so? And would we have to go through the entire process of getting approvals from, I mean, the regulatory authorities or the markets where we plan to supply these quantities?

Anish Swadi

executive
#49

So mostly, what will happen is since the plant is already on the U.S. FDA property, right? So it's also considered to be U.S. FDA approved per se because of the quality standards and the procedures are all following global regulatory standards. So from that perspective, we're fine. Individual customers may or may not come and do their own audits per se. And obviously, when you commercialize a new plant, especially for pharma and for potentially animal health, those products will be validated and then commercial supplies will start thereafter. So it's going to be a mix of products that we already have in the pipeline. So for example, we have some commercial products in the pipeline that we're already manufacturing. So as a derisking measure, we may put some of those products in this new asset to meet capacity that we want. And in addition to which we'll have a diversified range of new products that are coming from pharma and animal health. And of course, we have our spec chem business also that continues to happen.

Unknown Analyst

analyst
#50

Okay. And on the payback and the -- I mean, the return metrics for both the animal health plant and the [indiscernible] plant, when do you see optimal utilization and breakeven and then your peak utilization?

Anish Swadi

executive
#51

Yes. So it's the same as [indiscernible] mentioned, we follow the same metrics. It's anywhere between 5 to 6 years, as you said earlier. We follow the same metrics.

Operator

operator
#52

The next question comes from the line of Ankit Gupta from Bamboo Capital.

Ankit Gupta

analyst
#53

So first question is on the pharma side on the OAI being issued by the U.S. FDA. So do you -- like given how the OAI works, so what happens to our existing pipeline of products that we'll be doing for the -- on the CDMO side for our innovator partners? So are we trying to shift it to the Panoli plant? Or what kind of corrective action are we taking? And are our innovator partners shifting these products that they plan to launch to other CDMO companies?

Sameer Hiremath

executive
#54

So what we've done is that after this OAI status, all our customers obviously reached out to us and came and checked out all our systems and all the projects that were awarded to us. And irrespective, even before this, many of our products as part of our risk mitigation were already being filed from Panoli. For example, almost 80% or 90% of our Animal Health new portfolio is being filed from Panoli irrespective of this OAI status. So that continues as is. On the API side, on the human API side on both the generics and the CDMO space, all the new filings we are doing from Panoli, the existing products which are in Bangalore, which we were launching, we've given the customers the option of either keeping it in [indiscernible] and Bangalore or to moving it to Panoli. So far, they're comfortable with keeping it with -- in Bangalore based on the orders and the quality satisfaction that they've done post the orders that have been carried in the last 2, 3 months. But there is a move to derisk, as Manoj mentioned, all our critical APIs, and we are proactively doing the filings from Panoli and also giving the customer the offerings to move the products to Panoli if they need. But very few have said that they want to actually move. Most of them are comfortable with keeping it in Bangalore itself. And they expect.

Manoj Mehrotra

executive
#55

The reason is that they are comfortable as of now with the corrective action, which we have taken. So -- and their audits have also shown that there is definitely a possibility in the next few months or maybe early next year, we can reverse this OA status.

Ankit Gupta

analyst
#56

But given Hikal's track record and your focus on the regulatory compliance, this overhead comes as a big surprise. You have also -- have always been harping on spending a lot on [indiscernible] assets, which keeps our asset turnover low because you have been guiding for a very good compliance track record. So can you talk about the nature of observations which have been issued and what corrective actions are we taking to reverse this? And any update on when is the inspection for the Panoli plant also due now?

Sameer Hiremath

executive
#57

First of all, none of the observations were to do with data integrity and they were procedure in nature. So that's where we are on the observations. Regarding the Panoli plant, the last audit was in 2023 with 0483 observations. And we're ready for an inspection. They come every 2, 3 years for an inspection. So we're due for an inspection maybe next year if not earlier.

Manoj Mehrotra

executive
#58

The same facility was approved by ANVISA Brazil and Japan PMDA, which are equally stringent. So okay, it has been a bit of aberration the way status by U.S. FDA. But we are sure confident that we'll get back where of our original track record.

Ankit Gupta

analyst
#59

Sure. So -- but do we have sufficient capacities available in the Panoli plant over the next year or two to fulfill the kind of demand that can come from the new product launches, which are planned for this year and next financial year?

Sameer Hiremath

executive
#60

Yes. We have -- as part of -- anyway part of our risk mitigation and our Project Pinnacle, Panoli site was being expanded. And most of the new CapEx that Kuldeep spoke about is being done in Panoli. And the Panoli plant is building up new plants and new assets. So this is part of the plan, and we'll be moving all our new launches to Panoli. And this was done before the FDA status as well. So we're just intensifying that now.

Operator

operator
#61

The next question comes from the line of Rohit Sinha from Sunidhi Securities.

Unknown Analyst

analyst
#62

So one question on this deferment side. I know you already have answered so many similar questions. But one thing on this deferment. Earlier actually, I mean, people are thinking about because of the U.S. tariff issues, people are deferring the shipments or ordering. So now although we know these are deferments and complete in second and third quarter. But given the kind of rate hikes came into picture, are we seeing any change in these orders or rates given the kind of tariff is there?

Sameer Hiremath

executive
#63

Manjoj, do you want to take that?

Manoj Mehrotra

executive
#64

Yes. When you say rate hike means, tariffs?

Unknown Analyst

analyst
#65

Yes, yes.

Manoj Mehrotra

executive
#66

So as of now, tariffs are not impacting the pharma business at all. And we believe that these deferred sales, as we mentioned earlier, will be recovered in quarter 2 and quarter 3. And I explained in our opening session as well, as Sameer mentioned that, yes, there's a process. Customers do their own audits and risk assessment post the FDA. And we have maintained the full transparency with all customers. There's nothing systemically wrong with Hikal facility or practices. Observations were mostly procedural, and we are confident of resolving them by end of September. We'll complete all the actions and then wait for the U.S. FDA to respond. And we are actively engaging with the agency to come out of it at the earliest.

Unknown Analyst

analyst
#67

Okay. Okay. Got it. And secondly, on the Personal Care segment, I know it's too early, but just if you can give some color on this opportunity which we are looking at and how much time definitely it would be to get the final approval from the customers? And how big revenue contribution could be there from this side?

Sameer Hiremath

executive
#68

Vimal, can you take that?

Vimal Kulshrestha

executive
#69

Yes. So you're right. This is really early for us to comment fully on this. But just to give you a perspective that these RFPs, normal time lines of approval is around 1, 1.5 years. And once you get this, then you get into the development of that molecule and then commercialization time lines, which is typically 1.5 to 3 years. Margins are good in this.

Unknown Analyst

analyst
#70

Okay. Got it. And these are largely for export customers or domestic also we'll be looking at?

Vimal Kulshrestha

executive
#71

So it's for both, but largely for export.

Operator

operator
#72

Sir, do you have any other questions? As there is no response from the participant, we'll move to the next participant. The next question comes from the line of Rohit Mehta from Axis Capital.

Unknown Analyst

analyst
#73

Apologies, I joined the call a little late. So apologies if you already covered this. I just wanted to know, so can you highlight reasons for there this deferment of revenue. So just wanted to know, sir, reasons for this and what is the process that customers would follow generally after this -- for this?

Sameer Hiremath

executive
#74

No problem, Rohit. So what's happened is that -- which I covered in my opening speech and Manoj spoke, is that the deferment happened due to the OAI status and customers came to recheck and reaudit the facilities, which takes about 6 to 8 weeks by the time they give us approvals. And all this has been completed as of end of July, and the shipments have started from July itself onwards, and we expect the ramp-up to happen in August, September, October, November. So we expect this deferment to the tune of approximately INR 50 crores from quarter 1 to be made out in quarter 2 and quarter 3. I'd like to reiterate again that no orders have been canceled and all contracts are in place and customers reaffirmed their commitment to pick up the product from us within quarter 2 and quarter 3. So we are quite relatively confident that this will be made up within the next 2 quarters itself.

Unknown Analyst

analyst
#75

Right. That was very helpful, sir. So just a follow-up on that, it would be helpful if you could just highlight status of our response that we would have filed to the U.S. FDA. Is it have all been cleared or is it still pending?

Sameer Hiremath

executive
#76

So there were a few observations that were given to us. Based on that, we had corrective actions, preventive actions called CAPA. A large majority of them have been already implemented and updated to the FDA. We are in constant touch with the FDA on a regular basis. The last update went in end of July, just a week ago. The remaining CAPA, which is a small percentage is remaining, and that will be completed by September. So that by end of September, we will complete all the CAPAs -- and we are expecting to hear back from the FDA in the next few weeks, next month or so regarding the next steps. We are actively engaging with them, and we are also quite confident that we should be able to resolve the issue at the earliest.

Operator

operator
#77

The next question comes from the line of Parth Vasani from KK Advisors.

Unknown Analyst

analyst
#78

Just excuse me if there's any repetition. I got disconnected in the [indiscernible]. So I had just one question. If you could highlight what are the measures that you have taken to address the OAI.

Sameer Hiremath

executive
#79

Yes. So we have -- obviously, this OAI status has come as a bit of a surprise for us because, as you know, for the last 25 years, Hikal had a stellar record with the regulatory authorities. And immediately after this inspection, we had 2 inspections from Brazil and PMDA Japan, which is equally stringent and those went off successfully. So that being said, when we got to know this OAI status at end of May, we were -- we knew the observation. We started working on this post the observations which were given to us in February. And we have onboarded external global regulatory consultants, who are helping us to close out the observations and the [indiscernible] on an urgent basis. We've also collaborated with some of our global customers who are -- whose quality teams are working with our quality teams to ensure that all the responses are done properly and all the systems, whichever needles and course corrections have been done. We have onboarded several new industry experts into the quality organization, created a quality excellence team in the company and provided more and more digitization and automation has been implemented in the organization. In addition to that, we have also started moving more and more products to our Panoli site and we're validating several products at our Panoli site, which was anyway part of our program, but that has only been intensified and speeded up. Most of our new molecule launches were planned anyway for Panoli and the existing business, which is remaining in Bangalore, we've offered our customers the option of dual sources, dual sites. And as of now, they're comfortable with the site in Bangalore based on the audits and the visits that they have undertaken physically at our sites in the last couple of months.

Operator

operator
#80

The next question comes from the line of Manoj Bagadia from Equicorp.

Manoj Bagadia

analyst
#81

Sameer, just one question about the FY '26 guidance. Do you see any other risk to the FY '26 guidance apart from the deferrals what we have seen in pharma?

Sameer Hiremath

executive
#82

Well, I mean, regulatory tariffs is -- I mean, global tariffs, not regulatory. Tariffs is a question mark, right? As of now, pharma is not covered by tariffs, but it's anybody's guess, right? Things are so fluid and changing if there's any that's not -- but that will affect the entire industry, not affect us.

Manoj Bagadia

analyst
#83

Right, right. Okay. So tariff is the only thing that you are worried about, right, in case if it comes.

Sameer Hiremath

executive
#84

Yes.

Manoj Bagadia

analyst
#85

Yes. And my second question is, in last 4 years, you would have spent almost INR 900 crores in CapEx, right, investments in businesses. And somehow because of the situation, whatever has happened, we have not been able to generate much return on that and with what happened with the U.S. FDA, again, that is probably differing to an extent. And apart from that, one plant we are converting into pharma, right? So whatever has happened, now do you see that FY '28, you would have the best return from the CapEx we have invested instead of FY '27? Or do you feel FY '27 will capture significant upside from these investments?

Sameer Hiremath

executive
#86

No, that's the plan. I mean, yes, you're right. I mean the CapEx has been spent in the last 3, 4 years. Some of it has gone towards growth CapEx. A large part of it has also got towards infrastructure CapEx. We have spent a lot of money on our R&D center in Pune. We have upgraded our Panoli facilities in the last 2, 3 years to get U.S. FDA inspected in '23 and a lot of infrastructure was spent in Panoli on the CapEx as well. That being said, yes, the plan is on FY '28, '29, all the CapEx should surely start returning the return that is expected to give.

Manoj Bagadia

analyst
#87

So FY '26 would not be as per your expectation, right, original expectation. It would be probably somewhat lower than what you would have expected earlier?

Sameer Hiremath

executive
#88

Yes. More or less, I mean, we had planned because the crop business are doing a lot of stress as of now. The pharma business will grow. Can we grow faster for sure, but it will definitely grow compared to last year, the pharma business. And we're quite optimistic with the new NCEs that we're launching in human and in animal health, the future is extremely bright for the pharma business. And even with the crop business with the volumes coming back, which Vimal spoke about by end of this financial year and volume recovery is already beginning. We have also onboarded some new customers and won some new RFPs, which will start coming into play by '27, '28. So then our crop business capacity utilization will also grow up significantly, and that is about operating leverage. So returns will look far healthier than where they are today.

Manoj Bagadia

analyst
#89

Sameer, all the best for the future. And just one suggestion request, whatever you say. I've been an investor in this company for almost 12, 15 years, I don't know how long, right? In last few years, the return as the investor has not been much because of whatever factors have happened. But hope we catch up in next 2, 3 years, we catch up for the returns of last 5, 7, 8 years. I hope for that.

Sameer Hiremath

executive
#90

I hope we can -- we'll meet your expectations.

Operator

operator
#91

The next question comes from the line of Pranay Dhelia from Panchatantra Advisors LLP.

Pranay Dhelia

analyst
#92

Yes, I hope I'm audible.

Operator

operator
#93

Yes sir, you are audible.

Pranay Dhelia

analyst
#94

See, another very disappointing set of numbers. If we just go back by 3 months, last con call, we were promised that growth has returned and we'll see better days ahead. And we always talk of the long term whenever we have a shattering quarter. But as the previous person gentleman asking the question said, if you look at the last 10 years' data, I think that is good enough to judge long term. Our profit growth has been 8%. Last 5 years, it has been 1% negative. Sales growth has been 4%. So when does this long term actually translate into the present term? Or do we just hear long term for the grandchildren?

Sameer Hiremath

executive
#95

No, I don't think that's going to be the case. I think we have a detailed plan called Pinnacle, which is very detailed out a very structured plan, and we're going as per that. Despite the quarter one being -- even the quarter one last year was a very low quarter. But as we said, we grew substantially in quarter 2 and by quarter 4, we ended the year very positively. So this quarter, yes, there was a setback because of deferment, which was not anticipated 3, 4 months ago, but that has happened. It is what it is. But we have a very elaborate plan which is put into place to ensure that the growth comes back this year. And we have plans to derisk our portfolios. And the crop business, once it comes back to steady state of what it was in FY '23, the crop division had grown until FY '23. Yes, pharma went up and down, but it will come back to those levels and then the company will start firing on all cylinders. It's a matter of 2 more years, I think pharma will come back this year and crops will come back in the year after that.

Pranay Dhelia

analyst
#96

So what you're trying to imply is for 2 years, we'll be having these swings here and there, and we don't see any constructive growth.

Sameer Hiremath

executive
#97

I didn't say that. I said we will see growth next year as I have given my guidance.

Pranay Dhelia

analyst
#98

With all due respect, sir, as a shareholder, we would be happier if the company does well. But you'll have to have some kind of limit on our patience wherein you've been invested in the company, forget the share price, that is always going to follow the fundamentals. The fundamentals refuse to improve. You would be agreeing to me, if I say last 5 years, we've had flat sales and no profit growth at all rather degrowth.

Sameer Hiremath

executive
#99

The numbers are there. I mean what do you want me to say?

Pranay Dhelia

analyst
#100

We must find some way to improve on it. I mean even on the pharma side, we are having industry bottom margins. We look at all other pharma companies, they've improved. There's something which we are doing wrong, which needs to be corrected. The long-term world just does not hold good anymore.

Sameer Hiremath

executive
#101

No, point is noted. I think we appreciate your long-term investment and your patience in the company. And I just would reiterate to you to remain invested and we're turning the corner and the future is bright.

Operator

operator
#102

The next question comes from the line of Sajal from Antifragile Thinking.

Unknown Analyst

analyst
#103

So Sameer and Manoj, a question is directed to both of you, if you can, please. So my sense is PMDA visited many weeks after U.S. FDA visited and raised those critical observations. So the CAPA must have been largely completed by the time the Japanese regulators visited, right? And so while customers may have been reassured following this CAPA implementation, it kind of unequivocally indicates that Bangalore plant was noncompliant prior to this corrective action and this breach likely undermine customers' confidence putting future projects is still pending award to Hikal at significant risk being awarded to our competitors now, right? So how will Hikal convince both the existing as well as the new customers to award fresh contracts in light of what has happened with this OAI?

Sameer Hiremath

executive
#104

Manoj, it's all yours.

Manoj Mehrotra

executive
#105

Yes. See, the U.S. FDA audit happened in early February. This was followed by Anvisa in April, Anvisa Brazil followed by May PMDA. So every agency or every auditor who comes to the site has a different way of looking at the same thing. So yes, U.S. FDA, we got 6 observations, and we gave them a response and we corrected and we are in the process of correcting. But both Anvisa and PMDA of the same facility give only a few minor observations. So it may not be 100% right to say that we were noncompliant in the period February, March. We have always been compliant. Yes, there are some procedural observations, which we are correcting. And even U.S. FDA has not kind of put any embargo on our products or production or shipments. It is more for a future that we have to correct. And customers, when they came to audit us also, they have been satisfied with the progress. And even before this U.S. FDA inspection, customers do come regularly and visit and audit. So things were -- have been good, okay, there were some miner aberration, which we'll correct now. I don't think this OS status reflects any fundamental noncompliance at the Bangalore site. And as recent as 2019, we had just a single observation in Bangalore. Panoli was done in 2023, and that was a 0 [indiscernible]. So we have had a good history for the last 20, 25 years, and we continue to -- and we are confident that we'll bounce back after this OAI status.

Unknown Analyst

analyst
#106

Sure, Manoj.

Manoj Mehrotra

executive
#107

We have several examples in the country as well. Things do go wrong and you have to take it in your stride and correct it.

Unknown Analyst

analyst
#108

No, no, of course, of course, Manoj. I mean all of us appreciate that, I mean, science is a moving target and new regulations keep coming our way and we got to be on your toes and Hikal has been.

Manoj Mehrotra

executive
#109

Also, it's very subjective observations, yes.

Unknown Analyst

analyst
#110

Yes. No, that's fine. Typically, customers face a penalty for canceling contracts, the CDMO contracts in particular, which likely explains why they are still honoring their current agreements. However, this may lead to -- and may is the keyword here. This may lead to -- lead them to kind of rethink and reevaluate their options for future agreements. Is that a possibility?

Manoj Mehrotra

executive
#111

They have continued to engage with us and they've audited and they are confident that they will -- that we'll come out of it very soon. There's no risk to product quality or any impact of that kind. So we don't see that much of a risk, yes. There's an OAI status, we will correct. There are no real scenario yet. There was no concerns people would have canceled orders or canceled contract. But fortunately, that has not happened.

Unknown Analyst

analyst
#112

Okay, sure. And finally.

Manoj Mehrotra

executive
#113

[indiscernible] they know that these things happen and they work with you, I'll say the other way, because they have approved you. So they also believe that things are correctable. And they work with you to joint -- they work with us jointly to ensure that.

Unknown Analyst

analyst
#114

No, I agree on that point, Manoj, for sure, because we have seen that with Divi's who got U.S. FDA very -- even there was an import alert, if I'm not mistaken, back in [indiscernible]. Customers flew all the way from U.S., and they worked shoulder to shoulder with Divi's guys and they sorted everything out within a matter of -- off the top of my head, I think 6 to 8 months. No, that.

Manoj Mehrotra

executive
#115

It's a partnership. It's [indiscernible].

Unknown Analyst

analyst
#116

Yes, yes. No, absolutely. And Sameer, you mentioned that H2 will outperform H1 this year, but isn't that typically the case for Hikal anyway? And many of the other CDMO companies, I mean, you look at Piramal, you look at Laurus, I mean, you name any. Typically, what we find is that H2 is heavier because in Q3, customers don't want to take shipment because it's their year-end December quarter. So they don't want to put inventory on their balance sheet. So Q4 anyway is very strong for the industry. So how does this Q4 this year is exceptional that we need to call it out separately that H2 will be stronger than H1. I mean that anyway has been -- if you look at the history of Hikal over many years.

Sameer Hiremath

executive
#117

I said that was because of the loss of quarter 1, the additional deferment that is taking place, which was not anticipated in the regular year in the past. So that is going to have an additional upside on the H2 numbers beyond H1. So that differential between H2 and H1 will be greater than what it historically used to be for us.

Operator

operator
#118

The last question comes from the line of [indiscernible] Bagadia from Equicorp.

Unknown Analyst

analyst
#119

Sir, for the last 10 to 12 quarters, we've seen a massive slowdown in the crop protection side, and we actually refocused the strategy more towards the CDMO part. So I mean, we did plan to get into complex generics, and we also plan to do the CDMO part for the impatient molecules for the customers. So I mean, where are we out there? And what -- how have we seen that move in the last 10 to 12 quarters in terms of our revenue contribution? And also, if you could also allude what percent -- what's your aspirational target for the CDMO part across all the 3 verticals, Animal Health, pharma and crop chem?

Sameer Hiremath

executive
#120

Well, we are moving -- getting involved in more and more complex products as a percentage of our business. We're getting involved more and more on on-patent chemistry, I would say, rather than complex. On the generic side, yes, the products are more complex, which we're launching compared to the commodity portfolio that we probably had about 4, 5 years ago. All the new launches we are doing is more on niche chemistry, niche molecules that we will be launching in the next few calendar years. So that's a big change on the pharma side. On the -- the second question was regarding what is the split between own and CDMO, right? That was the question that you had.

Unknown Analyst

analyst
#121

Yes, what's the split and what's your aspirational target? Where do you see going about 3, 4 years down the line?

Sameer Hiremath

executive
#122

Well, CDMO has already overtaken even in this quarter significantly the own products. And the revenue, it will be almost -- historically, it used to be about 50-50 as a company, if you look at historical last 3, 4 years.

Unknown Analyst

analyst
#123

Yes, historically...

Sameer Hiremath

executive
#124

We are moving towards 60-40, 60 CDMO, 40 owned. And very soon, we'll get to about 70 CDMO and 30 owned in the next couple of years.

Unknown Analyst

analyst
#125

Okay. Sir, since a lot of our crop chem capacity is not completely utilized, so is it possible to convert it into other spec chem as we've done in spec chem, we have converted into part pharma and part we are going to do on the spec chem side. Because as we get into the HPC and the BPC, that is the Beauty and Personal Care products and household personal care products, I mean, one of our peers, they have guided for about 2x volumes and even more EBITDA growth. So I mean, because they are seeing a lot of traction out there and since we're also there in the sulfur chemistry. So I mean, do you see some kind of fungible shift happening?

Sameer Hiremath

executive
#126

No, I think so. The industry is looking quite promising. And we're retooling some of our crop production lines to make personal care products and the launches are being done from quarter 3 onwards from our [indiscernible].

Unknown Analyst

analyst
#127

So what will be the CapEx there?

Sameer Hiremath

executive
#128

Very marginal. We are retooling a few very, very negligible. Because our crop finishing areas are built at very high standards for multinational companies. So we've been audited by the personal care global companies. They've come and visit our crop sites, and they've approved them for personal care products with some documentation upgradation, et cetera, et cetera, which is easily repurposable and done, which we are doing.

Unknown Analyst

analyst
#129

And lastly, on the CDMO part. So if you see the industry, a lot of companies actually get contracts because they've got a CRDMO. They've got a resource vertical also. So for us, I mean, we were masters in process chemistry where we could produce probably cheaper than most of the other CRDMO players. So I mean, we have invested significantly on the research side in the last 5, 6 years. So I mean, do you see going forward, we can monetize this kind of vertical that we provide outsourced research services or probably get a CRDM vertical too in order to increase our traction on this -- I mean, the CDMO to CRDMO side. As you said rightly said earlier, we are 50-50 and probably aspirationally, we can go to 70-30 also. I mean it helps us also make the research as a cash cow or cash generating unit.

Sameer Hiremath

executive
#130

No, that's a very good question, and that's actually the strategy. Our R&D center has moved more towards CRDO and that builds into our CDMO engine. And all the new projects -- most of the new projects we are winning is starting in R&D in development, making a few kilograms and then scaling up and then moving into a CMO model. So it's always contract development first, which is a CD part and the MO part is coming subsequent because we have a good strong R&D, we're winning more CDMO projects. And the R&D center in Pune is being looked at more as a profitability center, it is generating revenue, and it -- it will generate business for us also for our CDMO business.

Unknown Analyst

analyst
#131

So is it right to aspirationally assume going down, I mean, 3, 4, 5 years down the line, other than the crop chem and the pharma segment we see right now, we probably see animal pharma, crop chem research as a separate division and the spec chem division, I mean, targeting, I mean, HPC, BPC as of now and probably some other industries also.

Sameer Hiremath

executive
#132

Yes, I think 4 verticals for sure. But the R&D will feed all the 4 verticals because it's really state-of-the-art R&D center. And it is built on innovation and technology. Because eventually, once you scale up the product and do the launches on a commercial scale, that's when the big volumes and the revenues come. R&D, every project value is very small, but it gets your stickiness with the customer because they involved early on in Phase II, Phase III with the customers, and then they don't change once they're in the supply chains.

Operator

operator
#133

Ladies and gentlemen, that was the last question. I would now like to hand the conference over to Mr. Sameer Hiremath for closing comments.

Sameer Hiremath

executive
#134

Thank you, everyone, for joining our quarterly earnings call and for your continued interest in our company. We appreciate your support as we navigate through the challenges of the global business environment. As we conclude this call, we want to assure you that we are here to address any further questions or concerns. Please feel free to reach out to us or our Investor Relations partner, Strategic Growth Advisors. Once again, thank you for your participation, and have a good evening.

Operator

operator
#135

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

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