Good evening, ladies and gentlemen. Welcome to our post-results teleconference for the fourth quarter and the financial year ended March 31, 2023. On 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 Director's Office. I'm sure you would have gone through the financials and other material which we have filed with the stock exchanges. To begin with, let me give you an overview of the performance in the year gone by. As we progressed through the year, all businesses demonstrated strong momentum and delivered double-digit growths consistently. Consequently, we closed the year on an encouraging note with overall revenue growth of 14%. Our EBITDA growth of 16% was faster than the revenue growth, thanks to margin improvement achieved during the year.
Our Formulations business in India built further on the growth momentum from the previous financial year and registered double-digit growth through the year-on-year COVID adjusted base. Our Consumer Wellness business grew in double digits despite softer consumer demand due to increased inflationary pressure affecting discretionary spends. Performance of our US Formulations business improved significantly during the year as the business grew sequentially every quarter on the back of volume expansion and meaningful new product launches throughout the year. As a part of our ongoing initiative, we continuously analyze our spend base and identify and implement various ideas across functions to unlock the efficiencies in our operations. Our innovation journey continues to make progress and achieve important milestones. With that, let me take you through the financial numbers for the year gone by.
During the year, we recorded consolidated revenues of INR 172.4 billion, a growth of 14% year-on-year. EBITDA margins expanded during the year despite high base and stood at 22.4% of the revenues, which is an improvement of 30 basis points over the previous year. EBITDA margin adjusted for one-time COVID-related inventory provision stood at 23.1%. The consolidated EBITDA for the year grew by 16% to INR 38.6 billion. Net profit for the year adjusted for certain exceptional and non-recurring items and the impact of discontinued operations stood at INR 26.6 billion, up 16%.
The balance sheet strengthened further as we had a net cash position of INR 5.5 billion as on March 31, 2023, against the net cash of INR 0.6 billion as on March 31, 2022. With this, let me go to our performance for the quarter gone by. I'm happy to inform you that our quarterly revenues crossed the INR 50 billion mark, driven by robust performance across segments. Coming to the quarterly financial numbers, we registered revenues of INR 50.1 billion, up 32% year-on-year. Reported EBITDA for the quarter was INR 12.6 billion, up 75% year-on-year and 31% quarter-on-quarter. EBITDA margin for the quarter stood at 25.1%, which is an improvement of 620 basis points on a year-on-year, and 260 basis points on a quarter-on-quarter basis.
Net profit adjusted for certain exceptional and non-recurring items and the impact of discontinued operations stood at INR 9 billion, up 71% year-on-year. We expect all our businesses to sustain healthy growth on the back of our rich portfolio of products and focused execution efforts. Let me take you through the operating highlights for the fourth quarter of FY 2023 for our key business segments. Our India geography, which comprises of Formulations and the Consumer Wellness business, accounted for 41% of the total revenues during the quarter and grew 11% year-on-year. The India geography consistently delivered double-digit growth in the current fiscal, adjusted for COVID-related revenues in Formulations business last year. Our Formulations business in the India geography posted revenues of INR 12.9 billion, up 11% year-on-year. Excluding revenues from COVID-related products, growth during the quarter was 12% year-on-year.
On a full year basis too, the business delivered 12% growth excluding revenues from COVID-related products from the base. We continue to work towards strengthening our presence in our focused therapy areas. Our first new chemical entity, the brand Lipaglyn, continued to enhance the reach as it expanded the patient base by 37% during the year. On the super specialty front, we retained our leadership position in the nephrology segment, while in the oncology space, we were the fastest growing company. Our Consumer Wellness business recorded revenues of INR 7.1 billion, up 12% year-on-year. The business experienced gradual recovery in consumer sentiments during the quarter, though the urban demand still remained stronger than the rural demand. The rural demand slowdown seems to have bottomed out, and we expect recovery going forward.
With appropriate price increases across the portfolio undertaken over the last few quarters, coupled with stabilizing inflation in key inputs except milk, the business registered improvement in gross margins and was in line with the gross margin of Q4 FY 2022. Let me take you to the performance of our US Formulations business. The business accounted for 46% of the consolidated revenues during the quarter, with revenues of INR 22.5 billion and registered a robust 17% growth sequentially. The business delivered sequential growth during each quarter of the current financial year. Growth during the quarter was driven by new launches and volume expansion in existing products. We launched eight new products during the quarter. New launches for the quarter include Topiramate extended release capsules, which was the first generic launch of the product in the US market.
During the quarter, we filed twp additional ANDAs and received 28 new product approvals, including 5 tentative approvals. Our Emerging Markets and Europe Formulations business continued to deliver healthy growth, with all the major markets contributing to the growth during the quarter. The business posted revenues of INR 4.4 billion, up 34% year-on-year, excluding revenues from COVID-related products. During the quarter, our Moraiya Formulations facility successfully completed the pre-approval inspections, inspection for transdermal patches by the US FDA. Recently, we received the EIR report from the US FDA for this inspection. Our Formulations facility located in Ahmedabad SEZ, known as SEZ 1 facility, was also inspected by the US FDA, which was a pre-approval as well as GMP inspection. The inspection concluded with 3 observations.
We submitted our response to the US FDA within the stipulated timeline and are awaiting their response to the same. This concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers across businesses and initiatives in our innovation program. Thank you.
Thank you, Dr. Nayak. Good evening, ladies and gentlemen. It is a pleasure to have you all with us today on the call. We are pleased with our performance during the quarter and the year gone by as both our large geographies, India and US, continue to deliver consistent results driven by focused execution. Our initiatives in R&D have continued to progress favorably in order to meet patients' demands across geographies. These investments provide us assurance of sustainable revenue and cash flow stream in the future. On the regulatory front, our Moraiya Formulations facility successfully completed product pre-approval inspection by the U.S. FDA. This was the second successful inspection at Moraiya during the year. We will continue to offer high quality, safe and effective healthcare solutions to patients around the world, thanks to our commitment to upholding high quality standards and continual improvement in the same.
Our strategic initiatives and interventions over the last six quarters have enabled our India Formulations business to deliver consistent double-digit growth. We expect the trend to continue as we remain committed to deliver better than industry growth in the medium term. The US Formulations business had a very successful year, with revenue momentum continuing to improve every quarter, driven by new product launches and volume expansion. We received 63 ANDA approvals during the year, which is one of the highest number of ANDA approvals received in a single financial year for the company. The complex products pipeline developed in-house over the years, coupled with the strategic BD&L efforts, should help us deliver sustainable revenue growth in the future. Our agile supply chain will help us capitalize on the one-time buy opportunities that emerge in the US generics market.
On the innovation front, we are committed to improving patient lives, as evidenced by the success of our first NC saroglitazar since its launch. We have also created one of the most extensive pipeline of biologics serving multiple markets, including low and middle income countries. This has made the treatments affordable and accessible for patients, and in turn has delivered strong volume growth consistently. With this, let me talk about some of the material developments on the innovation effort. On the NC front, our lead molecule, saroglitazar magnesium, is currently undergoing a phase IIb clinical trial in NASH indication and a phase IIb/III clinical trial for PBC indication for the U.S. market. During the quarter, we received approval from the regulatory authorities of Turkey to conduct trials for NASH. The molecule is also undergoing clinical trials in the U.S. for PCOS with an approval indications.
During the quarter, the US FDA also granted an orphan drug designation status to our molecule ZYIL1, an NLRP3 inhibitor. Earlier this year, the molecule achieved positive proof of concept in a phase II clinical trial in patients with cryopyrin-associated periodic syndrome known as CAPS. Coming to our vaccines effort. On the global development front, we submitted our dose, one of the doses of the vaccine to the WHO for the purpose of pre-qualification. This is the second submission to the WHO. Our rabies vaccine has already been received WHO pre-qualification. On the specialty front, our wholly owned subsidiary, Sentynl Therapeutics, continued to work with our licensing partner, Cyprium Therapeutics, to complete the NDA filing of CUTX-101, targeted at Menkes disease. The company also continued to work towards adding both Menkes disease and MoCD Type A deficiency to key genetic lab panels in the US.
We are also working towards ensuring early access to NULIBRY to patients of MoCD Type A deficiency. Thank you. Now we start the Q&A session. Over to the coordinator for the Q&A.
Thank you very much. We now begin the question answer session. Anyone who wishes to ask questions may raise your hand from the participant tab on your screen. Participants are requested to use headphones or earphones while asking a question. Ladies and gentlemen, we will wait for a moment while the question queue assembles. First question is from Saion Mukherjee.
Yeah. Hi. Am I audible?
Yes.
Yeah. Hi, Dr. Sharvil. First question is around the U.S., you know, momentum. We have seen a good momentum here now. Can you throw some light on some of your key assets on Revlimid, you know, Topiramate Capsule, Asacol HD and the likes? How should we think about, you know, $270 million that you've achieved in this quarter? How should we think about, you know, the quarterly run rate going forward?
Yes, I think on the U.S. front, as you said, obviously last year, we did continue to improve quarter-on-quarter. Going forward also we still are seeing a strong quarter one as we move into the new year. I think over the full financial year, we still expect a growth on the current base.
Okay. On Topiramate particularly, you know, how is the competition like in the market and is the numbers going to come down significantly in Q1 versus what you've recorded in Q4?
Yes. On Trokendi, we believe competition will enter, will be there in Q1 versus Q4. Having said so, in spite of that, I think we will see a good growth in quarter one.
Okay. Two questions. One on, you know, the second question on, I see a, you know, significant increase in our, you know, employee cost this quarter. If you can give some, you know, color on that and your expectation on R&D spend for next year.
On employee cost, maybe Nitin, maybe you would like to take it up.
Yeah, year-on-year basis, the increase in employee cost is because of impact of increments. Also if you consider, you know, actuarial valuation that we have done. This time, you know, we had actuarial loss that we had to provide for. In the last year, same quarter, we had actuarial gain. That's the other factor which is impacting the personnel cost.
Okay.
On the R&D, as we continue to say we are likely to be around the 8% range, and if we see better positive outcomes on more projects, maybe 8 and a half, but we are probably range bound around that 8% to sales going forward.
Okay. I mean, you mean to say, incremental investments would be largely on, your innovation programs or on the generic side?
I think more so the incremental growth will come from the innovation programs.
Okay. Okay. Thank you.
Thank you.
Thank you. The next question is from Kunal Dhamesha.
Hi. Thank you for the opportunity, congratulations on the good set of numbers. Just, you know, digging a little bit more on the U.S. revenue, would you be able to kind of, you know, give the primary driver on a quarter-on-quarter jump of roughly $40 million, in terms of whether it was majorly new product launches or whether it was kind of existing product ramp up and also the price erosion scenario in this quarter?
Obviously the larger jump is always because of new products. As I said, the base business also did well. The majority of the growth is driven by new products. Not only we have received rich number of approvals and we are also still expecting some good approvals in during the year with limited competition. We are seeing a good value creation on the new products in this coming financial year.
Would you say that Revlimid was one of the major driver on a sequential jump?
No, no it was an important driver for sure. Revlimid will continue in quarter one also.
Okay. Secondly, on the impairment charge that you have taken on Sentynl, I thought that we had we are already done with that, you know, Sentynl impairment. Was there anything incremental which led us to take this impairment? Right now let's say in the goodwill number on our balance sheet, is there anything left?
On that front.
Goodwill impairment of Sentynl refers to the legacy business that we had acquired of Sentynl in 2017. Now we don't have any products in the market. Gradually we, you know, started to discontinue certain products. Now there are no more products of the legacy business, that is why we have provided the assets which are two assets that we acquired. They have nothing to do with this. In fact, the valuation of the total business was, you know, much higher than the goodwill impairment. Once we at a concept level thought that legacy business we are not continuing, we have provided full amount of the goodwill of acquired business.
Right now there is nothing left about Sentynl.
No, no, nothing left. Nothing left.
Right now, whatever I see on functional balance sheet must be more or less the Heinz acquisition.
Yeah. There were some goodwill, you know, due to internal merger also and Biochem acquisition earlier, which is about INR 500 crore. Large part of the goodwill is related to Heinz acquisition.
Okay. I have no more questions. I will join back. Thank you.
Thank you. The next question is from Bino.
Hi. Good afternoon to all. Sharvilbai congrats for a great set of numbers. A couple of questions around the US pipeline. Sharvilbhaii, in the last call you had mentioned about 1 REMS product in the US around mid this year. Are we on track and would you be able to throw a bit more color on it?
We did have a large REMS payment in the last, quarter three. I think we are still planning for a quarter one. We have two products. Between a quarter one and quarter two launch is still expected for both the products.
Okay. Still it's not time to reveal the products, is it?
It doesn't make sense because, you know, it's like, it's defies the principles of competition if we say things beforehand.
Oh, okay. Okay. Understood. you know, Asacol HD competition always, we kind of push out by at least 6 months. Is it the same this time as well? Do you have any visibility or do we don't not see anybody for next six months?
Yeah, our best estimate is similar to what you just said. I think the good thing that we can see from the business is with the current new products and the new products that we're expecting to launch, we are more than offsetting Asacol any future losses.
Got it. On saroglitazar, the PBC study, phase three study, is that on, you know, going as per schedule, all timelines are intact?
Mostly on track. We may be one month delayed, but not anything major.
Understood. Great. Thank you. I'll join back the queue.
Queue. The next question is from Surya Patra.
Thanks for the opportunity and congrats for the great set of numbers, sir. My first question is on the U.S. business front. Is it possible to share, let's say ex-exclude, Revlimid, what could be the US growth this year if I did?
No, I don't think we can do ex product because this is something the U.S. business is a composite business of all our products. I don't think we are separating out new products. The way the U.S. business grows is you try and protect your base and grow on new products. you know, I sometimes find it very difficult to answer these questions that every time people want to remove products and then the whole point of the U.S. business is to launch new products. I think this way of continuing to ask these questions is not good in the light of what our U.S. business is.
The other point I said on if it's a concern on Revlimid continues to drive value in the last quarter, in the coming quarter, and will continue to drive value over the next two years. It's not a one-off product which people seem to think.
Yeah, yeah. Yeah, of course. Now having seen a ramp-up and progression on the Revlimid front, is there any sense about what volume share that we might be getting? Some sense, if not the specific number.
Sorry, can you repeat that question?
Having seen the ramp-up on the Revlimid prescription front for you and also in the business so far, could you give some sense, what is the kind of volume share that you are expecting, let's say for till, let's say progressively till 2026? Till now we have not been commenting anything on it.
Directionally volume share are going to go up, but we can't obviously give specific numbers that being a settlement.
Okay. Sure, sir. My second question is on the, let's say, the kind of approval that what we have seen this year, that is a record number of course for U.S. Wanted to have a sense that, see there are many, small value or small targeted value products that we have witnessed in the list. These are like old filings which were pending because of the Moraiya facility issue and now getting released or it is the filing of for installation passed only which are getting.
It's a mix of both.
This is about this.
I think there's a lot of background noise where you are talking from. I'm finding it difficult sometimes.
Yeah. Yeah. Sorry. I was asking about the number of approval what we have witnessed this quarter, or this year also full year. Whether means we planned and filed for these products having very low target value in U..S or what is in going out.
The U.S., I think, let me explain the strategy on US. US is a you know, US we are servicing key clients, key customers. A representation of having a large product portfolio is very important for US generic business, and that is always what we have believed in. We strongly believe that a completeness of portfolio is critical. From our point of view, we believe whether they are small or large, all products are important for us from servicing the customer. We will be launching small value products also, depending on the market situation, because there is a need to service the patients and the customers. Of course, we also look and file the difficult to do products which have far larger opportunity.
From our strategy point of view, US, we will be launching all types of products because one important aspect of what we do is to create access for these products. We have a plan to do that.
Okay. My next question is on the domestic business front. Now it is quite clear that, at least, during last one-year period, we have witnessed our core business delivering much faster than the industry growth or the complex portfolio. Here, progressively going ahead, how should we think and overall portfolio, how should that be growing or performing versus the industry? Whether we have seen improvement in the profitability in the domestic business. Also, if you can share the specialty portfolio's contribution in terms of % or in terms of mix in the domestic formulation business for FY23.
Yes, we are putting efforts behind our India formulations business to continue to drive market growth or at least better than market growth. I think so far in the last year, we have achieved most of the time better than market growth. In the medium term, we also want to aspire for building better than market growth, which will mean gaining market share. It will be driven across the mass and chronic therapies. I don't think the plan is to only drive one specific type of therapy, but we are present both in the mass segment as well as in the chronic specialty segment. All in all, I think on the composite side, that will deliver at least market growth and our aspiration is to drive better than market growth.
Improvement in the profitability from the domestic base business. Any sense on that, sir?
It's a good profitable business. On a medium term to long term, it will drive better profitability, we will continue to look at opportunities to continue to invest in this business also. Yeah, it's - it will be our effort is to drive profitability also.
Okay, just last one small clarification, sir. This WHO warning against artificial sweeteners. How should that have impact on our, let's say, key brand under the consumer health business?
Very early to give an answer to that. This study is not a new study. I think it doesn't say not to use the sugar substitute. It has come out with some finding which we are studying. I don't see an immediate impact. We will keep, we'll have our plans to counter that effort also.
Sure, sir. Yeah. Thank you. Wish you all the best.
Thank you.
Thank you. The next question is from Prakash Agarwal.
Hi, good evening. Am I audible?
Yes.
Yeah, congratulations on good set of numbers.
Thank you.
Couple of questions. One is on trying to understand your comment on, you know, new launches and volumes. US growth you had mentioned is led by new launches and volumes. When you say new, you know, new volume or one time buying opportunity, these are like, you know, short-term, 3 months kind of opportunity? These are 6-month kind of commitments or year kind of commitments? What is the typical size when you talk about these?
One-time buys, by their very nature, are not long-term. They are obviously for that month, not even for that quarter generally. We continue to see those opportunities in that market.
Different products.
Product to product, it's not the same product all the time. I don't think these are like contracted or assured businesses, but those opportunities do exist in the market. As I said, on the overall guidance that I said, we, what we are trying to do is maintain and protect our base and find new products to grow from that. That's been the effort, and that's what sort of helped us in the last many quarters, and will also deliver better results in the coming quarter.
Yeah, these are sizable in terms of like, you know, $10 million-$20 million kind of opportunities or these are small ones?
They are sizable.
Okay. Fair enough. When you say new launches, you mentioned you had 63 approvals, which is record. How much was converted into new launches and how much of those 63 are yet to be launched?
We launched 32, and we are planning to launch 35 this year.
Okay. In terms of, you know, you mentioned that fiscal 2024 is also looking good despite, you know, good base which we have achieved in fiscal 2023. You mentioned the Revlimid, and apart from this new launches and Trokendi still be a good product. There are two REMS you mentioned, right? One is expected this quarter and the other one is next quarter. Is that the right understanding in terms of, you know, stacking the growth drivers?
Trokendi has already faced competitions versus quarter four. Obviously, it will come down. We have launched the other Topiramate, which will add value, and then we have going forward some critical launches in the next three months. We believe if we are successful in two out of the three also it is good value.
On the U.S., we can still see high single digit growth despite a very strong performance in fiscal 23?
Yes.
Okay. Here you are factoring in ESOP or not really factoring in ESOP?
Even after factoring ESOP call, we still will have a single digit growth.
Okay, lovely. That is great. Secondly, on guidance performance. Last year, similar time the guidance on R&D were about 8%. We did around 7%. This year we are also guiding about 8%. Anything, you know, to read out there? What is the margin like? You know, we could see better margins going forward or this with 8% R&D at 22% is a good margin to model the system.
We are seeing maybe in spite of building for a 100 basis point increase in RND, we are still building for at least another 100 basis point increase versus last year. That we are still seeing. We are seeing good improvement in margin going forward. We, that's the current best estimate that we can give.
So 23%?
Many things have to work out and maybe we are being conservative, but hopefully that's what we will try and achieve if even assuming some things go wrong.
Assuming there is no competition, Prakash on ESOP actually in spite of higher R&D by 50 to 100 basis points, we expect margins to go up by 50 to 100 basis points.
Oh, that is great. Okay, thank you. Lastly on India. We've seen good growth, double-digit growth coming in. April was a soft month. I mean, do you read an aberration or do you think too early to call or what is the, you know, you think industry and yourself will be double-digit growth this year?
See, I think that'll be difficult to say. I mean, we hope it's double digit, but it could be anywhere between 9% to 12%. It's very difficult to predict where the growth of the industry will be, because we have seen volume growth being a challenge on the overall industry. The other is also we continue to have price challenges with NLEM and other things. If you look at even our growth in the last quarter, it would have been at least 2 percentage points more had we not had the NLEM impact. Which we hope to nullify going forward by doing the right product mix and other areas. Those challenges will remain.
I think it's difficult to predict, but having said so, I think our focus on our critical brands, the new launches and more importantly our differentiated portfolio driving strong momentum in the market, I think in the medium term will allow us to outperform the market.
Okay. Last one here. The MR number if you can share as on March?
7,000 plus.
Field force.
Field force.
7,000 plus.
This includes the managers or this is just the field force?
Only field force.
Okay. Two full teams, sir?
One minute. Managers -
Sorry, this includes managers.
This includes managers.
Okay. Thank you, sir. All the best.
Thank you. Requesting everyone to limit themselves to with two questions. The next question is from Sameer Baisiwala.
Hi, thank you very much. Good evening, sir. A quick question on Vascepa. Your thoughts about when do you plan to launch? Are there any raw material availability issues and the market dynamics?
Vascepa was a welcome approval for us. We had predicted a little much later approval, but we got in the first cycle. We're preparing for the launch. Can't give the exact date, but we are working aggressively to launch the product. On the supply side, I am confident we'll be able to get enough material, which is a limiting factor in the market. We are - we believe we will have enough, hopefully enough material to launch to get good share.
Great. The second question is on the U.S. launches. Can you talk about the transdermals?
Sure. Transdermals, as I said, after successfully clearing our Moraiya facility, we have been in preparation for launching the products. We are planning for three launches, and those will be staggered from the July quarter onwards. In this financial year, we at least hope to do three launches from Moraiya.
Okay, great. Sharvilbhai, if I have to summarize the US calendar, you've got two REMS, three transdermals, Vascepa, and I guess all of them should be fairly meaningful, substantive. Anything else that we are missing out?
We do have at least another five programs which have high value. If we are successful in three also, it should significantly be good.
Okay. Sharvil, this is quite a handful and you still expect just a single digit sort of a growth for US? That's surprising, no?
Well, we have to also plan for the negative side, which is competition to products, right?
Base.
The base is also quite decent, so a small erosion also is a meaningful erosion.
All the very best for you, for fiscal 2024. Thank you so much.
Thank you. The next question is from Kunal Randeria.
Hi. Good afternoon. Sharvil, if I understand correctly, you will maintain a generics R&D spend at around the current level of INR 1,300 crores and the incremental spend will be on NCEs, right?
No, INR 1,300 crores?
We have told the total in FY 2024 will be 8% to 8.5%. Normally the additional amounts would be more or less for innovation portfolio only and not the generic portfolio.
Sorry, I was not asking just for 2024. It's a slightly longer term kind of a question, the next two to three years, because you will have a lot of NCE spends coming up.
There will be very little or no growth on the generic side because we have hit a base which is comfortable. The most, as I said, the future, delta of growth that comes on research with the growth in revenue is all gonna be towards, I mean, the NCE and NBE portfolio.
Yeah. Sure. Just one more. On the U.S. side, what's the kind of price erosion that you are expecting? How are the competitors behaving? We have seen some shortages going up. We have seen some ANDA withdrawals by competitors. Just to get your thoughts on how, you know, the market is evolving for FY 2024.
We always build for a single-digit. I mean, before we used to see very strong double-digit erosions. We are building for a single-digit price erosion because that's what we expect to happen in FY 2024 in the best estimate. Obviously in the last quarter we haven't had any major erosion. Knowing the portfolio and knowing competition, we on a conservative side, we should assume a mid-single-digit price erosion.
Right. This price mid-single digit erosion is pretty much similar for all product forms like, you know, oral solids or injectables or transdermals?
No. If you are different alone in the market, the erosions are significantly larger. When I'm saying that, I'm talking for the whole portfolio. Otherwise, the erosions could be significant depending on how much, how exclusive you are in the market.
Sure. Sure. Of course. Thank you, and all the best.
Thank you. The next question is from Sindela.
Yeah, thanks for the opportunity. My question is on transdermal. You said that you'll be launching most probably 3 products in the coming year. Can you highlight the competition scenario that you expect in this? You have already highlighted that this will be meaningful launches for us. What kind of duration do we expect them to be? A 2-year long opportunity? How should we see it?
It's difficult to predict how, what will be the competition, because that is difficult to know. There aren't many transdermal developments going on. We at least believe that many of them have at least, I would say at least a twp-year opportunity. Could be longer, but two years definitely.
Even for the REMS, two. REMS product that we spoke about, even for them also the similar scenario we can expect?
I can't predict for the REMS. REMS are not transdermal, so those are two different technologies. REMS I would say when we launch, we will still have limited competition, but it will be difficult to say there will be no competition in the medium term to long term.
Right. When we look at pricing scenario in U.S., like not just for our portfolio, but overall industry, how do you see the US pricing today? If you can segregate it on based on products like orals and injectables, can you help us understand some color today? How does it look?
It's a very competitive market with a very consolidated buying. There is no fundamental shift that has happened in the structure of how the U.S. business is. Price erosion will continue to be there. As I said, the only way to explain it is when the portfolio is mature, the erosion there is not severe. Obviously if for portfolios where there is limited competition, with competition, you would see more price erosion. As I said, we estimate generally about single-digit price erosion. It could be low single-digit to high single-digit, but that's the range that we are operating in.
On the NCE side, what kind of investment do you expect over coming 2-3 years? As you were just now talking about, the entire investment will be on the IP side or the NCE side. What is the plan over two to three years? What all geographies like, you know, apart from U.S., any other reg markets, what kind of what is your thought process on this, on it if you can share?
The NC developments are global developments, they cater for U.S. and Europe and also the developed countries. As I said, when we're talking about the investment is overall investment, we are talking about 8% to 8.5% of spend, which will include generics and NCs, which would largely be for the clinical programs. As the programs reach the clinical phase, the investments goes up. Saroglitazar is our largest current investment that is going on. In the future, we have ZYIL1 and which is entering phase two and phase three in the future.
A few more, but these are all orphan assets, so the investments are over a period of three to four years, and they are I mean, from our estimate in the current 8-8.5%, we can manage our R&D expenses with these two or three programs.
Yeah. On the R&D side, I think you're being clear. On any other kind of investment, do you think like on ground, teams, preparations, all those you will, you need to invest or you're planning to do it now or maybe later when we are closer to the phases, that's where you will decide?
Generally, the investment starts one year before the launch and the major large investment six months before. If, we have our current assumption is that we will commercialize in calendar year 2026. Calendar year 2025, we'll see major investments.
Okay. Thank you so much and all the very best.
Thank you.
Thank you. The next question is from Harith Ahamed. Yes, Harith, go ahead. I think there is some issues. The next question is from Neha Manpuria.
Yeah. Thanks for taking my question. sir, you mentioned high single digit growth for the US. you know, just wanted to clarify, this growth would be on the base that we reported in the quarter, I'm assuming. Is that fair to assume?
Over FY 2023, yeah. We're talking of growth in FY 2024 over FY 2023.
In that case, you know, even if I were to take the higher end, range, we're assuming that our quarterly run rate would probably come up from what we have seen in this quarter.
I said not for the next quarter immediately, but going forward, we have to also assume competition, so.
Okay. Given that we have, you know fair bit of launch with the transdermal launches, you know, Vascepa, etc. Are we being too conservative on this number?
You have to understand if a base price erosion is also there, and we have to assume for that also.
Okay, understood. My second question is on the injectable business. You know, could you give us some color in terms of how big it is, what we are targeting, you know, how many launches do we have planned for that, and what's the pipeline there?
I don't have the breakup like that, but I think for us, when we talk about the U.S. generics business, we talk about whether it's a oral solid, topical, transdermal or injectable. I think it's a composite way of doing business. Having said so, the business, there are good amount of complex filings that have happened on the injectables, and we would, we hope to see at least 1 or 2 important launches this year. Many of the launches will be post 2025, 2026, where we would see highly complex products coming to market. It's still a medium-term opportunity, not a short term, but currently it's at a good base and there are shortages and other issues in the market.
We are the growth and momentum is very good, but it'll become sizable probably post 2025.
Understood. Thank you, sir.
Thank you. The next question is from Tarang Agrawal.
Hi. Good evening, and thank you for the opportunity. Couple of questions, just to follow up from the previous participant. Currently, how big would your injectable business be, and what would it be in the previous year? That's one. The second, I mean, you're generating sizable cash now, and, historically, you've not shied away from leveraging the business as well. Is there a possibility of you probably, you know, looking at growing your business inorganically? If so, where could we see this getting deployed?
I think today we are not giving the usage-wise breakup. I think that is not something that in our guidance we are giving. Having said so, I have explained that on the injectables front, the meaningful revenue in terms of the overall business will be post 2025, but the momentum and growth is very good. With respect to the future investments, as I said, we have two important markets, India and U.S., which we look at. U.S. from the specialty point of view, where we want to build our presence. That's one area which we look to find opportunities to invest in. In India, we are continuing to look for brand acquisitions, if available.
That's one area that we will look at. We have been seeing very strong progress on our developing markets business, including Europe. It's growing very well and it's becoming an important part of our business. We hope, on, I would say, opportunistic basis to see if we can find some opportunities to leverage our portfolio there.
Okay. Thank you.
Thank you. The next question is from Nitin Aggarwal.
Hello?
Yes.
Yeah. I was saying, sir, on the developing markets you just mentioned, from a growth driver perspective, what would be the driver of this, you know, what is the strategy for growth rather in this, in this non-U.S. markets for us? I mean, it's largely going to be driven by biosimilars. Are there other elements of growth also that you're focusing on?
No, it's biosimilars will add over a period of time to the business. Today the business is strongly driven by branded business, branded generics business, with areas focusing on cardiometabolic and C&S space. As I said, we have a focused market strategy where we have deep penetration in certain markets in which we have identified and the others we do through distribution. A majority of focus is to deepen our presence in the markets where we are very strong. Those markets, in spite of fluctuations in currency and other things, have continued to deliver good growth. Now are becoming good profitability also. We will continue to drive those.
It's to do with mostly new product launches, but mostly in the, I would say, in the CNS and cardiometabolic space.
Yes. Secondly, on the U.S. market, this new business opportunities that you sort of referred to, have you seen increased incidents of these opportunities coming through in the last few months? How do you see this, sort of, is this a consequence of what, facility closures and all which have been happening because of FDA, recent FDA, or post recent FDA inspections? Do you see momentum in this part of the business increasing as we go along?
The earlier question was related to where I would invest in the future, and that was more to do with the specialty business, which is not with the current businesses which are sort of generic. Generics business, I think on our own, we do have a very rich pipeline. We are filling up the gaps or finding opportunities through BD&L opportunities and really been, have been able to license very difficult and good products from the generic point of view and complex generics point of view. Beyond that, our effort will be to look at the specialty business and invest behind that and not in the current generics business.
Lastly, Sharvil I think we mentioned earlier in the call that on Revlimid the assumption is the volumes will keep increasing. Philosophically, is it fair to assume, you know, how should we look at Revlimid as a business? The revenue should be 2023 numbers that are like the peak numbers or numbers should actually increase through the next couple of years before they come off?
Our current best estimate is the, with the volumes increasing, the numbers will go up at least for the next two years.
On a consecutive basis.
On a?
I mean, on successive years. I mean, 2024 would be higher than 2023 and 2025.
Yeah.
Should be higher than 2023.
Yeah. as I said, we do still high expect quarter one sales of Revlimid also.
Thank you very much.
Thank you. The next question is from Harit. Annie, can you please get the next participant?
Yes.
Hello? Hello?
What happened? Hello?
Just a second. Just a second.
Are there no more questions?
No, there are. Just a second. Yeah. Harith is here.
Yes. I don't think we are hearing anybody.
Yes, exactly. The next question is from Vishal.
Hi. Good evening. Thanks for the opportunity.
Yes. Vishal, can you hear us? Hello?
Yeah. We are trying to -
Hello.
Yes, Vishal, you can speak.
Okay. on the two REMS asset that we are expecting to launch, are we going to launch them as an authorized generic or under our own ANDA?
Own ANDA.
Okay. Would you be able to share the indication of the 2?
No, we won't be able to do that.
Okay. second one.
Once we launch, we will update everybody.
Right. second one on the Menkes disease asset, any timelines for approval?
They are in their rolling NDA stage. It's difficult still to give a timeline. I would be able to give better understanding maybe in two quarters, but not before that.
Okay.
Okay.
On the vaccine front, do you expect to file any more vaccines for WHO prequalification this financial year?
We have two vaccines, the TCV and the MR. Those two will be going for WHO prequalification.
The one that you filed, this quarter was for which indication?
TCV. It was TCV.
Typhoid conjugate. Okay. The two that you're going to file are for,...
1 we already have, which is the rabies, then typhoid conjugate and measles rubella.
Okay. Okay.
We are also doing prequalification for some other products, but slowly we will add more products. These are the current plans.
Would you have a number as to how large the WHO market is, for TCV?
I can share it offline, but it's a very, very large market. We can share it to you offline.
Got it. Just on the Africa and Europe business, which grew sharply this quarter, can we expect that kind of a run rate to continue for the rest of the year?
Yeah. It will have a strong double-digit growth.
Any color on what drove the strong growth this quarter?
It's a branded business, so it's quarter-on-quarter good performance.
Across the board.
Across the board.
Okay. It was across geographies, not any specific.
Correct. Yes.
Okay. Thank you.
Thank you, Vishal. The next question is from Nisar Pari.
Sorry. Hi. Am I audible?
Yes.
Hi. Thanks for taking the question. My question is on oncology. You know, across both Indian and U.S. formulations, what would be your share of oncology and, you know, how is that growth going?
In India, we are now a leading oncology player. Our aspiration is to be in the top three and one day achieve the number one rank, if possible. That's what we're aspiring for with the kind of access of medicines we are creating, which are largely driven by biologics and also some small molecules. That's our aspiration. We are amongst the top five or maybe third, but we hope to be in the top few with adding more products to the basket. With related to beyond India and US, obviously it's not a branded business, the generics side. We do have two...
Three oncology sites, two injectables and one oral, and we are using those sites to build for the US oncology business where we do have some day one launches planned. I would say if we just look at the oncology business and US generics point of view, it's maybe three years out when we will see significant revenue uptake.
Okay. Got it. You know, in terms of capacity, be either in India or US, we are seeing a lot of people obviously putting up, you know, oncology plants over the last one or two years. Just overall from a demand supply situation and, you know, how we are seeing the growth in that segment, what is your view? Do you think that there has been, you know, increased capacity that we built and, you know, which is built for the industry and the next two, three years that could create some kind of oversupply? You think there is just enough demand growth?
To some extent, I do feel there is overcapacity. These need to be regulated, approved, I mean, plants that are approved in the regulated markets. I'm sure there is a little bit of excess demand because the volumes are not very high in oncology. I think it's, it'll depend on lot on the product mix and what type of products a company has, which will drive value, not the volume.
Okay. Got it. Thank you so much.
Thank you. The next question is from Puneet, and this is the second last question.
Yeah, hi. Thanks for taking my question. I have 1 question on specialty, yeah, innovations, initiatives. In saroglitazar PBC indication, there are two molecules that are ahead in terms of timelines. Both are PPAR agonists. By the time we launch, we'll be 4th player in the entire PBC market. Considering the rare nature of the market, how are you expecting the numbers to flow through?
On the PBC asset, we, our current business model assumes that we will be fourth or third. I think there'll be one PPAR and two others, but we assume we'll be, the worst case will be the fourth. There is a good case we can be the third, and our business case is appropriate for that. I mean, our investments are still very much appropriate for that scenario. The market is, as you say, it's an orphan indication, but it is a sizable market which is growing.
Understood. My second question, was on the, phase II trial we completed for ZYIL1. By when can we expect phase IIb/III to commence?
We are just finalizing that strategy. If everything goes well, we'll start in a quarter or maximum, five to six months.
Thank you, sir. That answers my question. Thank you.
Thank you. The last question is from Ishita Jain.
Hi. Just a quick one, relating to what the previous participant asked. On the products in the pipeline, the NCEs, especially products like the NLRP3 inhibitor, are these partnered products or is Zydus doing it independently?
We are doing it independently.
Including saroglitazar, nothing is partnered.
Yeah. Right now, all our development phase programs are done by Zydus individually.
Okay. That's great. Just a short follow-up. Once we are, like you mentioned, that you will be, expenses will increase as we are closer to the launch date. Will that also include expenses such as setting up, dedicated field force once we have, once we are closer to approvals?
Yeah. I think in that earlier question when they spoke, I was speaking about the field force and the commercial operations team we need it to be set up if we are seeing good data on Saro.
Understood. Got it. Is this the same approach is going to be used in the European market as well, or there are we going to out-license?
There's a higher probability we will out-license in Europe.
Perfect. Thanks a lot. All the best.
Thank you.
Thank you. As there are no further questions, I now hand the conference over to management for the closing comments.
Thank you very much. Have a good evening and look forward to interacting with you again in the month of August for the quarter one FY 2024 results. Good night.
Thank you. On behalf of Zydus Lifesciences Limited, that concludes this conference. Thank you for joining us, and you may now disconnect and exit the webinar.