Zydus Lifesciences Limited (ZYDUSLIFE) Earnings Call Transcript & Summary

Ladies and gentlemen, good day, and welcome to the Zydus Lifesciences Limited Quarter 4 FY '22 Post Results Earnings Conference Call. [Operator Instructions] Please note that this conference is being recorded. I now hand the conference over to Mr. Ganesh Nayak, Executive Director, Zydus Lifesciences Limited. Thank you, and over to you, sir.

Thank you. Good evening, ladies and gentlemen. Welcome to our post results teleconference for the quarter and year ended March 31, 2022. For today's call, we have with us Dr. Sharvil Patel, Managing Director; Mr. Nitin Parekh, Chief Financial Officer; Mr. Arvind Bothra, Senior Vice President, Investor Relations; and Mr. Alok Garg, Senior Vice President from the Managing Directors' Office. I hope you would have gone through the quarterly results investor presentation, which we have posted on our website and filed with the stock exchanges. I'm pleased to share our performance for the financial year '21, '22 as we continued our efforts to fight the pandemic through our therapeutic products and on-ground initiatives to support the health care fraternity. Though continued disruption in the supply chain and inflationary pressure impacted some of our businesses, our agile supply chain helped offset the impact meaningfully, thus ensuring reliable and timely supplies to our customers in key markets. The year gone by turned out to be good for our branded formulations business in India as the business posted strong double-digit growth consistently. On the consumer wellness front, the business environment remained challenging due to the COVID impact in the first half and the inflationary pressure in the second half. But importantly, the business retained the leadership in 5 out of 6 categories. Our U.S. formulations business continued to grow the overall volume and maintained top 3 ranking in 60% of the product families despite increased competition and pricing pressure. On the innovation front, the year saw several important milestones achieved by us. Dr. Sharvil Patel will speak about them in his talk. With that, let me take you through the financial numbers for the year gone by. During the year, we posted consolidated revenues of INR 152.6 billion, up 6%. Consolidated EBITDA for the year was INR 33.4 billion, implying an EBITDA margin of 21.9%. Excluding the impact of onetime COVID-related inventory provision of INR 1.8 billion, the EBITDA margin for the year stood at a robust 23.1%. Onetime inventory provision as mentioned above, input price inflation and continued pricing pressure in the U.S. business impacted gross margins adversely. However, continued efforts on the cost optimization and efficiency enhancement initiatives significantly helped contain the EBITDA margin decline. Profit after tax for the year was INR 44.9 billion, up 110% year-on-year. Excluding the impact of COVID-related inventory provision, as mentioned above, profit from discontinued operations and certain exceptional and nonrecurring items, our PAT grew by 12% during the year. Our balance sheet health improved significantly during the year with a negative net debt at INR 0.6 billion as of the 31st of March 2022 against INR 35 billion as of the 31st of March 2021. As a result, our net debt-to-EBITDA ratio turned negative and stood at minus 0.2x as on the 31st of March '22 compared to 1.03x as on the 31st of March 2021. Coming to the quarterly financial numbers. During the fourth quarter of FY '22, we posted consolidated revenues of INR 38.6 billion, up 5% year-on-year. Excluding COVID-related revenues, the growth was 7% on a year-on-year basis. Adjusting for the inventory provision of INR 1.4 billion made during the quarter, EBITDA was INR 8.6 billion, implying EBITDA margin of 22.3%, which is an improvement of 170 basis points on a sequential basis. Profit after tax for the quarter was INR 4 billion. Excluding the impact of COVID-related inventory provision, as mentioned above, profit from discontinued operations and certain exceptional and nonrecurring items, PAT stood at INR 5.3 billion, up 12% on a year-on-year basis during the quarter. Over the last few years, our endeavor has been to strengthen our position in the Indian market, particularly in the branded businesses. In line with this, the salience of the India geography, which comprises of formulations and consumer wellness business has increased from 37% of the revenues in FY '18 to 46% of the revenues in FY '22. During the year, the India geography business registered a healthy growth of 15% and posted sales of INR 67.9 billion. Now let me take you through the operating highlights for the fourth quarter of FY '22 for each of our business lines. Starting with our formulations business within the India geography. The business recorded sales of INR 11.6 billion during the quarter, up 14% on a year-on-year basis. Excluding sales of COVID-related products, the branded business grew 19% on a year-on-year basis. And importantly, the growth was well represented by volume expansion as well as better realizations. On a full year basis, the business posted a sale of INR 48.1 billion, registering a growth of 19% on an elevated base of last year. Excluding sales of COVID-related products, the branded business growth was 21%. We gained market share in our core therapies of antidiabetic, cardiovascular and gynecology during the quarter on a year-on-year basis. On the super specialty front, we continue to retain our leadership position in the nephrology segment. In the oncology space, we remain the fastest-growing company in India. Our consumer wellness business posted revenues of INR 6.3 billion with a growth of 6% during the quarter. Sales growth for the year was 7%. Now let me take you through the performance of our U.S. formulations. The U.S. geography posted sales of INR 14.2 billion during the quarter, down 4% year-on-year. On a full year basis, the business posted sales of INR 58.1 billion, down 8%. During the quarter, we launched 4 new products in the U.S., taking the cumulative number of new product launches for the year to 14. We received final approval for 5 new products during the quarter taking the cumulative number of approvals for the year to 28. Notable approval includes the receipt of final approval for Nelarabine injection, which was granted 180 days exclusivity. Cumulative number of ANDA filings and approvals now stand at 420 and 312, respectively. On the emerging markets front, the business posted sales of INR 2.8 billion, up 10% on a year-on-year basis. Excluding COVID-related portfolio, the business posted a growth of 29% during the quarter. Robust performance in key markets of Latin America, Philippines -- the Philippines and Vietnam drove the overall performance of the business. However, the situation remained challenging for our business growth in Sri Lanka in light of the ongoing political crisis. On a full year basis, the business posted sales of INR 11.9 billion, up 17%. On the operations and compliance front, our injectable facility at Jarol, which is the erstwhile Liva formulations facility, underwent a U.S. FDA inspection during the quarter. The inspection concluded with 3 observations. We have received 1 new product approval and 1 site transfer approval from this facility post the inspection. As shared with you on previous occasions, we continue to remain vigilant towards our cost structure and undertake various measures to optimize the same and remain competitive. Advanced digital and analytics tools being implemented in manufacturing operations would enhance compliance and efficiency through simplification. This now concludes the business review. I would request Dr. Sharvil Patel to take you through the strategic direction and material developments and initiatives in our innovation program. Thank you.

Thank you, Dr. Nayak. Good evening, ladies and gentlemen. It's a pleasure to have you here on the call today. I would like to update you on our strategic direction as well as share material updates on the progress made by us on the different R&D initiatives during the quarter. Over the past few years, we have had a strategic review of our businesses as we continue to build sustainable long-term growth drivers for the company. Certain loss-making businesses like Nesher and Hercon in the U.S. have been scaled down or discontinued as we continue to build pipeline and capabilities to improve our business mix in the U.S. We also want to position our specialty business as a rare and orphan disease focused organization and have been working on identifying identification of bolt-on assets to leverage the common platform. To sharpen focus on key growth engines and to free up management bandwidth, the animal health business divestment during the year also helped realizing optimal value for the business. These strategic direct decisions demonstrate an effort to streamline capital allocation, help improve return ratios to ensure better stakeholder value creation. I'm pleased to state that given our strong financial position with the net debt-free status, supported by onetime gains from the divestment of the India-centric animal health business, the Board has approved the proposal for buyback of shares at an attractive value to reward the shareholders. We remain committed to build long-term sustainable growth drivers for the company, and that reflects in our continued investment on R&D as we continue to progress on the innovation front. We continue to augment our capacities across and realign our manufacturing network to be future-ready across multiple technology and dosage platforms. We are leveraging automation and digitization to meet highest compliance standards and optimize cost per unit incrementally. Our business mix will evolve over the time to include more complex products with higher entry barriers, thereby enhancing our position in a competitive environment we all operate. I'd also have to throw some light on the broad strategic direction for the 2 of our largest businesses which is U.S. and India. We remain optimistic on the prospects of branded business in India and for both our businesses, formulations as well as the consumer wellness. In the India formulations business, we continue to focus on enhancing our presence in high-growth areas within the chronic and specialty segment. Moreover, we have aligned our business strategy to build select pillar brands and focus on new product launches, which will help us outpace the industry growth. Our biologics business is likely to sustain high growth momentum, cementing its position with one of the widest portfolios and fastest-growing portfolio in their respective categories. With a few first in market launches like Exemptia and Ujvira, we remain excited with our pipeline and this segment will continue to bolster our growth in India. On the consumer wellness front, we are leveraging our R&D strength to launch new products, which meet our consumer needs and ensure continued brand pool. Our distribution reach continues to expand and we aim to achieve healthy growth while expanding market share in each segment that we operate in and benefit from operating leverage, hence, stronger profitability as we navigate the near-term inflationary pressure. While we have built a formidable U.S. generics business backed by strong generics R&D effort, we continue to focus on differentiated products, ensuring a balance between high-volume and high-value complex products. While this would scale up in times to come, we are calibrating our R&D spend judiciously and supplemented with business development and licensing efforts to improve the ROI and to ensure on-time launches for commercial success. For the medium to long-term, we also have investing resources to evolve as a strong rare and orphan disease company. Our own NCE pipeline continues to progress well, and we will invest in a phased manner to ensure that saroglitazar meets his development goals for PBC and NASH indication that will translate into commercial success. Let me also talk to you about some material developments on our innovation front. On the NCE front, we have launched a novel molecule desidustat for the treatment of anemia associated with CKD developed in-house in India under the brand name Oxemia in March 2022. This launch will further consolidate our leadership position in the Indian nephrology segment by providing first-in-class solution to the specialist. Desidustat is also being evaluated for a global development. And currently, the molecule is undergoing a Phase III clinical trial in China for the management of CKD patients. The global development of saroglitazar magnesium. The Phase IIb/III global clinical trials of molecule to evaluate efficacy and safety in patients with PBC and the Phase IIb trial for NASH and Fibrosis and other indications are currently ongoing in the U.S. market in line with our current plans. Coming to a biotech, we have submitted market authorization application for -- to DCGI for rituximab and submitted an application to initiate Phase III clinical trials for 1 more monoclonal antibody during the quarter. We have also received GMP approvals for manufacturing facility from Mexican authority COFEPRIS for 3 products during the quarter. This will facilitate launching these products in the large opportunistic market of Mexico post their approval. Coming to the specialty initiatives. After the acquisition of C2X101, now branded as [ Zycubo ]. During the quarter, we entered into an agreement with BridgeBio Pharma Incorporated to acquire NULIBRY [indiscernible] for the injection. NULIBRY is approved by the U.S. FDA to reduce the risk of mortality in patients with deficiency molybdenum cofactor deficiency Type A, an ultra-rare, lifethreatening pediatric genetic disorder. With this acquisition, the company further strengthens its periodic rare and orphan disease portfolio. Commercialization plans for C2X101 for the treatment of Menkes disease are underway. The product is under a rolling submission and all modules of the NDA are expected to be filed during the current calendar year. We have undertaken various initiatives to create awareness for this disease, which is a rare disease. On the vaccines front, ZyCoV-D received an EUA approval as a 2-dose vaccine for the eligible population in the age group of 12 years and above. The vaccine will now be administered on day 0 and day 28, improving the compliance profile. Thank you. And now we will start the Q&A session over to the coordinator for the Q&A.

[Operator Instructions] First question is from Neha Manpuria.

First, I just wanted to understand on our India business. We've seen good growth in the quarter, even excluding COVID portfolio. Could you give us a little color on, is this a reflection of our initiatives that we have taken? And also how should we look at the growth for next year, given the high base?

So yes, we are very pleased to play an important role in the fight against COVID and that's been very good in terms of the overall business. But as we have recovered from the pandemic, I'm pleased to share that the India business has also started to register a healthy growth. Ex-COVID sales, India business grew by 90% for the quarter and 21% for the full year. This partially reflects the impact of our renewed strategy to focus on brand building. Also the strong momentum of our novel products like Lipaglyn, BILYPSA and Oxemia will further add to this growth. And also on the super specialty front, our biologics business continues to maintain strong momentum with major products leading in the category in terms of growth and in terms of patient enrollment. And also from the therapy focus standpoint, the chronic and the semichronic will give us a higher trust as we aim to strengthen our footprint in the therapies like cardiovascular, diabetes, gastro-intestinal, gynecology, respiratory, and also in the specialty segments like onco and nephro. So as I highlighted earlier, I think our endeavor is to outpace the industry growth sustainably now. And we are clearly seeing the path to achieve this.

Understood. And in the reported numbers for the quarter, is there any contribution from vaccine?

No.

No.

Okay. Understood. And second, the COVID inventory write-off, if I understood it correctly, this is all sitting in the gross margin, right? So if I were to adjust that, our gross margins seemed pretty strong despite the price inflation and the erosion we've seen in the U.S. Could you help us understand what's benefiting that?

So there are 3, 4 different factors. One is the business mix itself in terms of the growth that you have seen in India business. Another is a foreign exchange fluctuation, which is partly helping us in terms of realization and also our supply chain stocking various inventories before the price increase took place. On the other end, some of our business like Zydus Wellness was able to take price increase also. So multiple 3 major factors which contributed to this.

Sir, how should we look at the sustainable gross margin for next year?

So gross margin, Neha, would remain a function of business mix to some extent. But I think in terms of EBITDA, we are pretty confident of having 20% plus EBITDA margin.

Next question is from Binu.

Just a clarification on generic Revlimid launch now that we are close to it. Could we confirm if we will be part of the next wave of launches? Or would there be somebody in between -- launching in between the first wave and us?

We expect to launch this product in the next wave of the generic launches subject to the final approval in place. We have -- so I think we are backwardly integrated on the products. And beyond that, I don't think we can add more color to it, but we will be planning for the launch.

Okay. Great. And we have seen U.S. FDA inspections coming across many, many facilities. Do you have any heads-up on Moraiya?

So we are prepared to be inspected by the USFDA anytime, and we have hoped that the reinspection happens in the current year. As you said, the assumption of inspections have started in India. As I also earlier have mentioned, the majority of our high-value products, excluding customers have now been site transferred to alternate facilities. So from the risk mitigation perspective, it's good. And however, there are still a number of products which could potentially be launched from the site post clearance and we await the FDA to come and inspect.

Okay. Great. One last question on Asacol. Between last call and now, have you got any incremental information about any competition entry -- potential competition entry?

No, we don't see on the immediate basis, any potential entry, right?

Next question is from Pritesh Vora.

Sir, how do you see the India business going from here? And I mean, which area we are targeting in India business? What is the outlook on India business?

So I think I covered some part of the answer earlier already on the India business. So it's 3 things, right? On India, we have seen a strong growth. It's driven all across the segment for us. The future growth, we believe, will be driven by the chronic and subchronic categories for the company. Our novel products like Lipaglyn, BILYPSA and Oxemia will significantly add to further growth. And we are seeing strong momentum on our biologics business, which will maintain its growth trajectory, which will add to better growth and also better patient enrollment that is our ambition to do there. So we believe that we are poised to grow and plan for a better-than-market growth with some of these initiatives that we have taken across the important peer that we have mentioned earlier. So that's our current expected.

And my second question is about the API. We have seen some kind of a degrowth quarter-on-quarter and large degrowth on quarter-on-quarter as well as the Y-o-Y degrowth. So what is happening there in the API side?

So I think going forward, I think you would -- the growth will come. I think it is also wave effects during the COVID period, I think we had a lot of business that got -- that was created. So I think we were sitting on a good base. So I think going forward, we'll see some growth coming back, but it's more a basic thing.

[Operator Instructions] Next question is from Anubhav Aggarwal.

This is Anubhav from Credit Suisse. One question Sharvil bhai, on this product that you acquired NULIBRY. How big this drug could be in, let's say, in 2, 3 years? And how much you have paid for this for the U.S. market?

So NULIBRY, it's a very ultra-rare orphan disease. So the patient population that is there is very, very small. In Europe, this is a little bigger where they are now about 1,800 patients there. But in U.S., we believe there'll be 2 to 3 patients every year who would be -- who will be added to the ongoing book there. So it's a very rare disease. It's a disease that is terminal in terms of children who have very high seizure rates and their own survive. The payment for this is not anything significant at all. As I said, it's a rare disease. As I said, the company's philosophy, and we have committed to working on rare and specialty diseases where there are unmet needs and there are no medicine for. We picked up this juvenile or newborn area to work on. And that's why there are these 2 drugs, both NULIBRY and Zycubo, which will be going for the pediatric population. But the point, patient numbers always will be very, very small because these are very rare -- ultra-rare diseases.

Okay. And second question is Oxemia. What is the pricing that you have launched in the Indian market, that's one? And secondly, just from a patient perspective, if patient takes it, I think, in an alternate day basis, but for how long a patient needs to take patient who have CKD disease?

So it is a chronic treatment. It's not acute in nature. This has to be taken for mainly CKD patients for almost throughout the lifetime. And I don't have the exact pricing. It has -- silo I can't give you the exact rupee value on the tablets right now. But our endeavor is that today, the class of treatment is an injectable, which is erythropoietin, so we would -- which has also side effects and multiple [Indiscernible] syrup index. So this is a oral treatment to that. So we believe we will see a lot of conversion from the current mode of treatment and especially the new patients who are not on dialysis. We also see a significant opportunity in terms of this product. So we believe that markets like India and other emerging markets like China have a great potential with a large population of patients who have renal deficiencies and who have problems related to that in anemia. So there's a lot of opportunity for that. And the gross margins are good on this molecule, much better than the company gross margin.

So you have already commercialized this or you're about to commercialize this?

We have already launched it in March and very good traction from the first few months.

And last question, just a clarity on your vaccine contract of like 1 crore doses. Since you haven't sold much, so is there anything going to be commercial opportunity on those 1 crore dose contracts with the government? Or that may not materialize?

So currently, there is no demand there from the government so that we have not been able to fulfill that order because there's no demand for the vaccine in the adult population. What we are working on is to get our approvals. We already have approvals, but we are waiting for the final approval for the 12 years and above. And then our opportunity that we are now currently targeting is exports and also the private market. And if there are procedures that change with mix and match and booster and other things, then we would see some opportunities there.

And lastly, for the U.S. business, can you just give us some outlook? Do you expect next fiscal '23 to be a flattish year depend -- assuming -- I'm assuming that as ever competition comes maybe next quarter or quarter after that. So do you expect that to be a flattish year or a growing year?

So we expect that the -- on the U.S. business, there would be a price erosion in the mid- to high single digits, and that's what we are expecting. I think what is going to excel the U.S. business to grow is going to be new launches. We are currently assuming for FY '23 single-digit growth for the year. And -- but there are a lot of variables to it, and we have to see how everything goes. But we have a good pipeline of India still pending approval. We have some high-impact products that we want to launch in the second half of this year. And if all of that goes well, we would see a good -- we'll see a single-digit growth for the full year with a better second half than the first half.

[Operator Instructions] Next question is from Mr. Prakash Agarwal.

First question, again, a carry on, on the U.S. So I'm looking at my last notes, you mentioned that it is flattish or a partial decline is possible. Now we are talking about a single-digit growth. Anything changing in your assumption? Do you think the competition is away in Asacol? Or do you think the launches are chunky if you could throw some light there?

So while we continue to see price erosion and some part of base erosion, we believe that there's some upside to Asacol in the second half and also some 2 high-value launches that we believe can do good. So because of that, we believe that we can have a high single digit.

Okay. And a follow-up to that is on the other mesalamine product, Pentasa, so that is stuck due to Moraiya or?

So I don't think we give updates on to be launch products. So I don't think I can give you that, but we are working on a couple of other mesalamine franchise products.

Okay. Perfect. And secondly, on EBITDA margin guidance of at least 20%. So if any color could be given on the current gross margin or how we are seeing the input prices. We hear that packaging, freight, et cetera, all have gone up, as also mentioned by various companies. So what is the strategy here? Do we see that we take a lot of cost-cutting measures? Or how we want to address to this high inventory cost issues?

So Prakash, I think it works on several different measures. While we continue to work on cost rationalization, cost optimization initiatives by different programs, both in manufacturing, supply chain as well as marketing and other sectors. They are in variable feasible, we are also taking price increase to at least pass on, if not full, at least part of the price increase in various commodity items.

Next question is from Sameer Baisiwala.

Can you hear me now?

Yes.

Sharvil bhai, I don't know how you want to answer this, but just thinking do you think the upside from Revlimid versus negative from Asacol HD competition, how does the 2 factors stack up?

So I think it's very difficult to say when the competition is there in Asacol. As I said, currently, there is an upside because the competition is delayed. Revlimid is going to be a good sizable opportunity from our point of view. So that's a positive for the business. And we do have one more high-value launch. So I think that's the current update I have for the current FY '22. Beyond obviously, our high-value filings and first to file products that we have for the future.

Okay. But just if I can, if both were to get launched on the same day, which is Revlimid launch and competition Asacol HD, are the 2 comparable? I guess that's what I'm trying to get to, you don't need to quantify it.

No, obviously, they're not comparable.

Upside from Revlimid is much higher?

No, no, that we can't comment because we have not launched the product. So once we know about that and what is the pricing and all of that. So it's difficult to answer that question.

Okay, sir. No worries. And just on NULIBRY, what's the thinking behind taking this asset? It doesn't look like any meaningful commercial opportunity, maybe a lot of hard work you will build this whole infrastructure. So why get into something like this?

So I think our philosophy for the company going forward is that we will be working on therapies and areas where there are unmet medical needs. If you look at our current portfolio of Zydus also, when you look at saroglitazar for the treatment of PBC is also an orphan disease in the U.S., where there are no full line treatment for that. If you look at desidustat and when we're doing work on CK -- anemia chemotherapy-induced anemia, again, it's an orphan area. So I think what we have decided to play is that create a niche in this space of orphan and rare diseases. The -- I think we have -- as a responsible pharmaceutical company, we also want to make sure that while we do that, we also work on some of the neglected diseases of very rare diseases where there are no available outcomes. And I think both of these molecules have tremendous importance in terms of extending the life of young patients. So I think we looked at all of that and we decided to do that. Commercially, it is still meaningful for the size and scale of the company we are, and we do get a premium for being able to provide these medicines for this. And this business will slowly scale up. It's not something that can scale up overnight, but it's a very sticky and continuous business and with a very to threat on genericization.

And Sameer over a period, I think it will be a basket of such products, which will make a meaningful difference using common platform.

And so if I just give you an example on just NULIBRY also, even if we are recruiting 2 to 3 new patients every year, still a good business model for us.

Okay. Great. And one final is on ZyCoV-D. Sharvil, what's the outlook? I heard your commentary and good to see 2 dose getting approved. On the previous call, you mentioned you can do 3 to 5 crore doses for the full year. Now how does it look like? I mean, is it a meaningful commercial opportunity for this year?

No, I don't see it immediately being so. We -- I think our efforts are going to be to work on exports and the private market. And if the policy -- I mean, if the plan of vaccination changes in terms of mix and match and other things in terms of booster, we can see some opportunities. But we are not now talking about doing 3 crore doses because there's no demand currently for 3 crore doses. What we are also working on is the multi-variant vaccine for this because we are working with multiple strains to be put into 1 vaccine. So but that's a little longer-term development for this. So that's the current update.

Next question is from Dipen Sheth.

I hope I am audible, sir. Dipen from Buoyant Capital. Many of the questions that I wanted to ask have already been answered. So I'll take a slightly high-level issue. I would like to raise it for Sharvil to answer. We have raised a significant amount of resources on the balance sheet now, and we are literally pretty cash rich. I would guess that you're not going to let this ammunition remain idle for too long and you have a certain strategic intent with it, or would you be thinking in terms of returning it to shareholders? So a little bit of a buyback and all that is fine. But is there a concrete thought process here that over the next 1 or 2 years, do you want to put it into something which could be value accretive in some way? Is there any thinking around these lines? And if so, what is it?

So I think what you said is correct as we are looking to build our specialty footprint and extend it both in India and U.S. and also look at some other global markets in terms of partnerships. So I think some part of our investments will go into the buildup of our specialty business and the R&D associated with it for some of the products that we are developing. Second, we are looking -- we'll always look at some opportunities in India in terms of brand acquisitions that we want to look in terms of adjacencies that we want to create. There will be some capital investments now for enhancement of biosimilars and some vaccines, especially the global WHO prequalification vaccines like MR and TCV, which we are committed to, and we are seeing good visibility to that, and some investment on oral solids for our U.S. As I said, we are looking at network optimizing our -- optimizing our network to make sure that the next facility we build is best-in-class in terms of cost, and that's what the current work is going on.

Next question is from Prakash Agarwal.

Just, if I missed, I don't know, but R&D what we are guiding here in terms of percentage to sales?

About 8%.

About 8%. So my next question is on saroglitazar. Last time, we had indicated that filing expected by calender '24. Do we stick to that? And do we see a ramp-up in cost in fiscal '24, '25?

So saro -- yes, we are still looking to file this in '24 and commercialize it in '25 and the clinical work is ongoing. This clinical programs for both PBC and NASH, I want to be over 3 to 4 years because NASH is the '27, '28 launch, so filing a launch. So I think we should be able -- we are -- our current view is that we'll be around 8% of revenue will be spent on R&D over the next 3 years.

And would you say that your share towards NCE and innovative pipeline is increasing already versus generics investments in the R&D side?

No, it's almost same. I think about 2/3 is in generic and 1/3 in NCE.

No, I'm asking from a filing standpoint, once you are in fiscal '14 and fiscal -- fiscal '24, '25, would that share partly change, or you would be at similar levels also? I mean, the generic focus would be there.

The generics -- so I think we would not be having significant growth, I would say, on the current base. And based on obviously, biologics and NCEs will grow. So there will be some change towards that. But I think at this base of generic investment with some incremental growth, we should be okay.

Okay, perfect. And one clarity that there was a comment that there is no vaccine sales for the quarter. Is that correct?

It's very insignificant. There is some sale, but...

Not anything meaningful.

Okay. And the inventory write-off is not related to vaccine. It is related to the COVID-related drugs. Would that be correct?

No, everything, including related to vaccine.

It include little bit on the vaccine. Okay. Okay. And lastly, on the overall strategy, there was a comment on big picture cash utilization. So the extra buck, where is that getting deployed? So NCE is one area where you are increasing focus. But on the M&A side, India versus U.S.?

I think both markets are geographies where we're wanting to do acquisitions. We are -- U.S. is the specialty side and in India it's on the brands.

Okay. But you would have looked at these assets, which have gone in the last 6 months, there's a aggressive M&A that's happened in India.

Yes. So I think more than businesses, we are looking to acquire brands. So that's our more interest to do. So as far as some of them have not been meaningful for us.

Next question is from Vishal Manchanda.

This is Vishal from Nirmal Bang. With respect to your orphan drug portfolio in the U.S., wanted to understand how are you handling the diagnosis challenge because these are ultra-rare diseases. So how do you get to reach to the patient group?

Yes. So that's a very important part of the question and answer. I think the hard effort that is being put in for both the molecules is newborn screening. And we are working on developing the assays for the efficiencies that we want to see for both C2X and NULIBRY and new inborn screening assays are being under development with different universities. And that's how in the future, we will be able to find more patients. So initially, we will find patients more by talking to the doctors and making them aware of the disease and the side -- and the complications related to the disease. And at the same time, work on newborn screening assays, which we will also have to work to make it part of the state plans and the government plans to make sure they are part of the screening process.

And how long this development of assays can take?

So the assays we are hopeful, we can do it over the next 3 to 6 months, but to get it enrolled into the programs for newborn screening will be a long-ended effort. It will be a state-by-state effort over a period of time.

Right. So just on the other -- the copper histidinate Menkes disease, do we have a number on how many new born's get diagnosed every year or that number may not -- would not be available?

So I don't have it offhand, but we have all that data. If you actually visit our website also, you will see a little bit on that. But definitely, I can provide you offline the prevalence, the diagnosis and what are we looking at. And these are all ultra-rare diseases. So as I said, 1 of the products, we are looking at 2 to 3 new patients. In this, we are talking about 10 to 12 new [indiscernible] year.

And the annual cost of therapy can be a few lakh dollars?

Yes.

Next question is from Surya Patra. Next question is from Anubhav Aggarwal.

One clarity on the personnel cost. From a 1H average to second H average, we are seeing a reduction of INR 50 crores. Is that just absolute reduction in the personnel cost? Or is this just expense getting booked in other line items?

So one reason was that because we discontinued the operations of Nesher and Hercon, so people cost related to that is now no more there.

But the personnel cost was lower in third quarter also. So we were doing about INR 650 crore in 1Q and 2Q. Now third quarter, we're doing about INR 585 crores and now INR 600 crores. So -- and this discontinuation nature you would have done in this quarter, I guess.

No, during September. There are obviously a few people will still have to -- gradually they have been terminated. But I will get back to you with the exact numbers, if you want further details on that.

But the full cost saving advantage of that discontinuation measure has flown in now in this quarter.

Yes.

Next question is from Nitin Agarwal.

Sharvil bhai, on the U.S. business, what is the share of specialty business as it stands today after the discontinuation of Nesher and Hercon?

So we don't currently have any specialty business in any significant manner. It's -- so it's not anything meaningful right now because we discontinued 1 of the products, and so that was the only specialty business we have.

And aspirationally with the focus which is there on orphan drugs in the sole new strategy that you built -- building out, where do you see this number really getting to in, say, 3 years to 5 years?

So our effort is going to be to make the business profitable and grow it sustainably. As I said, the way to build on the or at least ultra-rare orphan side is to slowly build on to the patient flow and these treatments are lifelong. So you incrementally build the value on this. And that is going to be the expectation from the management to do so in the U.S.

And in the past, you've talked a lot about complex injectables being a very critical driver for your -- for the U.S. business growth. I mean any color you can provide on how the next couple of years looking like from a launch perspective on the injectable side?

So yes, injectables is going to be an important segment of growth for the U.S. generics business for us. Today, we have a mix of more simple products that we just started to commercialize after approvals and some complex products like liposomal, doxorubicin and [ enoxaparin ] the [ Effluent stat ] and the Nelarabine injection where we are exclusive. So slowly, we are building on to this launch pipeline, where we have a good amount of filings. And then we also have filed the first complex product in terms of the pen device combination product, so -- and more products are to follow. So that's how we're building on the pipeline of complex products for the U.S.

And from a size perspective, when do you -- task to become meaningful for your business because right now, it's primarily oral solid?

Sorry, can you repeat the question?

I mean the business currently is largely oral solids. When do you see injectables, when you say probably getting to a 15%, 20% of the business?

So injectable business overall will be part of the -- I mean, it will never become larger or larger sum of the orals business, but it will become an important part of the business. So I think is the sum of 3 parts, right? We are talking about our orals, including complex orals. We're talking about transdermals as 1 franchise and injectable. So these 3 franchises will lead to the overall growth and the aspiration that we have for our U.S. generics business. So I think we generally look at it as a portfolio of businesses, while injectable is one part of it. So we are not segmenting it one for the others.

One last one. Since you mentioned transdermals, so what is the thought process on the transdermal launches, as of today?

So transdermals, I think, an important stage gate for it is the inspection for Moraiya facility and then the clearance for Moraiya. Once that happens, we will see a rollout of transdermals. I think the business of transdermals is good. Once we are able to roll it out and take some shares, it's a more sticky business. So that's what we're looking forward.

Next question is from Surya Patra. Next question is from Sameer Baisiwala.

Sir, looking at the last slide, Slide #14, of your slide deck. And for fiscal '22, you had roughly INR 240 crores of income coming from FX fluctuations. A lot in other operating income, some in other income. And you have another INR 75 crores coming from profit on sale of investments. So we're talking roughly INR 310 crores, INR 315 crores of sort of one-off, so -- and this was not there in fiscal '21. So if you can talk a bit about it. And in your opening remarks when you had excluded all one-offs while getting us the net profit for fiscal '22, which was a 12% growth Y-o-Y. Did you exclude all of this? Or was this part of this?

No, it was not excluded, but -- so foreign exchange fluctuation has 2 components. One is a normal movement of dollar. Another is because of the forward contract that we have entered into on our receivable, and we have got the forward premium for that, which also gets classified here as a part of other operating income. And on profit on sale of investments is related to our surplus cash deployed for liquid funds, overnight funds, et cetera. So that is the income, which is on -- which could be less a part of interest income. Here it is on profit on sale of investments. That is on surplus cash.

Okay. Okay. I get it, sir. And so going forward, these income may come on the same line or maybe part of the business income, but should be continuing as we go forward?

So profit on sale of investment kind of income would remain. The comp maybe depending on the instrument that we invest in, maybe interest income may be continue like mutual fund investment income except to the extent of cash that we are now planning to use for buyback program.

Okay. And for the FX part?

Yes, FX, I think the position still rupee continues depreciating, and we have continued our forward contract for the existing receivables. So that benefit will continue.

We will take the last question from Vishal Manchanda.

Can you share your biosimilar numbers for the quarter?

No, we are not giving individually the numbers. But as I said, the biosimilars overall business is on a good trajectory and scaling up very fast, and it will become an important line of revenue for the overall India business.

Or else, if you can share the Y-o-Y growth for the biosimilars portfolio?

Much better than overall India formulation business.

It's significantly higher than overall -- I mean, the other India business.

I would now like to hand the conference back to Mr. Ganesh Nayak.

Thank you very much, and look forward to interacting with you again during our next conference, which will be in July, August. Thank you, and good night.

Thank you. On behalf of Zydus Lifesciences Limited, that concludes this conference. Thank you for joining us, and you may now exit the call.