Good evening, ladies and gentlemen. Welcome to our post-results teleconference for the quarter ended September 30th, 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. Now, let me give you a broad overview of the developments during the quarter. In terms of overall revenues, we registered stable growth of 9% during the quarter. Our branded formulations business in India grew in a single high digit after adjusting for impact of NLEM and partly affected by delay in the acute season. The US formulations business performed on expected lines, driven by stable base business and supported by new introductions. Our emerging markets and Europe formulations businesses continue with strong growth momentum and delivered double-digit growth.
Our network of regulatory compliant manufacturing facilities and a resilient supply chain serves as the backbone of our global business. We remain committed to extend our robust compliance record by maintaining the highest standards of quality and in turn, ensure uninterrupted supply to customers across the globe. Various digitalization initiatives undertaken across different functions have significantly enhanced the efficiency of operations and continue to deliver greater value to all the stakeholders. With that, let me take you through the financial numbers for the quarter gone by. We registered consolidated revenues of INR 43.7 billion, up 9% on a year-on-year basis. EBITDA for the quarter was INR 11.5 billion, with a growth of 41% on a year-on-year basis.
Operating profitability remained robust as we registered an EBITDA margin of 26.2% during the quarter, which is an improvement of 580 basis points on a year-on-year basis. Net profit for the quarter stood at INR 8 billion, up 53% year-on-year. Our balance sheet continued to strengthen with a net cash position of INR 16.4 billion as at 30th September 2023, as against the net cash of INR 5.5 billion as at 31st March 2023. Now, let me take you through the operating highlights for the second quarter of FY 2024 for our key business segments. Our India geography, which comprises of formulations and consumer wellness business, accounted for 42% of the total revenues during the quarter and grew 5% year-on-year.
As mentioned earlier, despite delay in the acute season onset, our branded formulations business in India grew in a single high digit, primarily driven by volume expansion and new launches. We gained rank and improved our market share in the antidiabetic and respiratory therapies on the back of continued efforts to strengthen our presence in focused therapies. On the super specialty front, we retained leadership position in the nephrology segment, while in the oncology space, we remained the fastest growing company. Our consumer wellness business recorded revenues of INR 4.4 billion, up 3% on a year-on-year basis. The personal care segment, which comprises of Nycil and the Everyuth brands, registered robust growth during the quarter, driven by a favorable season in many parts of the country. Gross margins continued to recover on account of moderating input prices and calibrated price increases taken earlier.
Now, let me take you through the performance of our US formulations business. The business posted revenues of INR 18.7 billion, up 9% year-on-year. On a sequential basis, though, the business de-grew by 24% on account of reduction in revenues of the limited competition product, which is in line with our expectations. We launched 8 new products during the quarter. New launches for the quarter include Indomethacin suppository, which was granted 180 days of competitive generic therapy exclusivity, and Plerixafor injection, which was a day one launch. During the quarter, we filed four additional ANDAs and received nine new product approvals. Our international markets business, which comprises of emerging markets and Europe formulations business, continued to deliver healthy growth, with all major markets contributing to the growth during the quarter. The business posted revenues of INR 4.5 billion, up 17% year-on-year.
On the operations front, we received an Establishment Inspection Report from the U.S. FDA for the inspections of our oral solid dosage Facility One and Facility Two, located in the Ahmedabad SEZ, and Biologics Fill Finish facility, located at the Zydus Biotech Park in Changodar. This concludes the business review. I would now request Dr. Sharvil Patel to take you through the key drivers, as well as initiatives in our innovation program.
Thank you, Dr. Nayak. Good evening, ladies and gentlemen. It is a pleasure to have you all on the call today. We remain focused on building long-term growth drivers and augmenting the innovation efforts in our focus geographies to enhance stakeholder value over time. On India formulations front, we continue to work towards strengthening our position across the focus therapies through multiple initiatives. Portfolio of our innovation brands continue to display strong volume traction over the last several quarters and helped patients to satisfy their unmet healthcare needs. We continue to evaluate multiple partnership opportunities and develop novel solutions, keeping in mind the unmet healthcare needs and patient convenience. The U.S. formulations business continue to display robust momentum, comprehensive product offerings, key new launches, strong customer relationships, and agility in operations have ensured sustained growth of our U.S. business and also going forward.
On the inorganic front, recently we announced our agreement to acquire U.K.-headquartered LiqMeds group of companies, which has unique capabilities in delivering novel oral liquids. The acquired entity has a good pipeline of products, which comprises of many 505(b)(2) and first to file and first to market products. The acquisition is in line with the strategy to expand the presence in the specialties space and offer novel solutions to satisfy the unmet medical needs of patients globally through a differentiated and niche product platform, liquid dosage forms. There's also a large population globally who suffer from difficulties in swallowing due to different diseases. Liquid orals would help such patients and in turn, bring greater ease of convenience and better therapy compliance.
Overall, we expect our U.S. business to continue its upwards journey going forward on the back of our robust product pipeline across the generics and specialty space. With this, let me talk about some of the other material developments on the innovation efforts. On the NCE front, we initiated a phase two clinical trial of ZYIL-1, a novel oral NLRP3 inflammasome inhibitor in patients with amyotrophic lateral sclerosis, which is a disease called ALS. ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of three-to-five years from the time of symptoms onset. We have already established a proof of concept of ZYIL-1 in a phase two trial in CAPS patients and published the data in Clinical Pharmacology and Drug Development. The U.S. FDA has granted an orphan drug designation to the molecule to treat patients with CAPS, a rare autoinflammatory disease.
We also received approval from CDSCO to initiate a phase one clinical trial for our novel PCSK9 inhibitor. The study will evaluate the safety and tolerability of this candidate, which will be administered subcutaneously in healthy human volunteers. Dyslipidemia patients with high LDL cholesterol are at a high risk of atherosclerotic cardiovascular disease events, such as heart attack and stroke. This PCSK9 inhibitor will regulate the level of LDL receptors, which are responsible for the uptake and clearance of cholesterol from the blood. On the biotech R&D space, our pipeline continues to advance well in line with our expectations, with the completion of clinical trials for one of the monoclonal antibodies and also patient recruitment for another monoclonal antibody. We have also received regulatory approval to initiate a phase three clinical trial for one more product during the quarter.
On the specialty and 505(b)(2) development front, recently we received the final approvals from the US FDA for two new drug NDAs, sitagliptin under the brand name Zituvio and sitagliptin metformin IR tablets under the brand name Zituvimet, in the area of metabolic disorder management. We also filed one more ANDA, which is sitagliptin and metformin ER tablet in the area of metabolic disorder management, to complete the franchise of sitagliptin combinations during the quarter. Thank you, and now we can move towards the Q&A session. Over to the coordinator for the Q&A.
Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may raise your hand from the participant tab on your screen. Participants are requested to use headphones or earphones while asking the question. We'll wait for a moment while question queue assembles. The first question is from Kunal.
Hi, thank you for the opportunity, sir. So the first one on the sitagliptin franchise that we are trying to build on 505(b)(2) side. You know, how do you see the addressable market? Is there any niche segment that we are targeting there? You know, obviously, because the innovator has been there for quite some time. And, secondly, would it require any incremental front-end investment from us? And, what could be our pricing strategy there? That would be the first question.
... So the sitagliptin franchise obviously is a large established franchise in the U.S. market. The most of the prescriptions are run through either commercial or Medicare segments, and they are mostly filled by the retail segment. So our strategy will be to go to, into the retail segment and see how do we get access through different PBM contracts going forward. And I think we'll have to slowly work on building the awareness for the product and also find the right ways to create the right contracts and, and look at taking market share. So I think it is going to be a slow process to build up this franchise, as it is not a substitutable or interchangeable product.
The good thing for us is that we'll be alone in the market for some period of time, which will allow us to create a good brand over the period of next 2-2.5 years.
Sure, sir. In terms of pricing, would we have any idea or we are still in the deciding phase?
So this is not a generic substitution, so pricing is going to be PBM contract, so it's difficult to give you an idea today till we launch and go through those phases.
Sure. And in terms of front-end marketing, do we require marketing presence, or can we use Sentynl?
No, our current strategy is that we will go through our, as I said, through contracts and listing and awareness area. So I don't think we are talking about a front-end team yet.
Okay. Okay, perfect. And secondly, sir, if I look at the other expenses this quarter, they have been quite, substantially down on a sequential basis. So any particular reason for it? How should we think, you know, from the future quarter perspective?
So other expenses also include R&D expenses, as well as expenses related to Zydus Wellness Limited, where there is some seasonality involved. Also, certain professional legal expenses. They are not uniform across all the quarters. So if you take out the R&D part, I think INR 850 crore-INR 900 crore would be the base, depending on Zydus Wellness promotion spend.
Okay. But, but R&D was also increased on a sequential basis, right?
R&D should not be viewed on a sequential basis. It should be viewed on annual basis, because it all depends on the projects, filing, registration, other, you know, expenses. On an annual basis, we have guided for 7%-8%. We stick to that guidance.
Okay, perfect. I have more questions. I'll join back. Thank you.
Thank you.
Thank you. The next question is from Saion Mukherjee.
Hello?
Hello, Saion, can you hear us?
Hello, am I audible?
Yes.
Okay, sorry. So, yeah, I was asking about, you know, the acquisition that you did for the liquid dosage form in U.K. So firstly, if you can, let's take us through medium-term outlook for this acquisition, because the revenue base is quite low at this point, and we paid almost GBP 60 million. So if you can give us some color on the pipeline and how should we think about revenues improving and if you can talk about profitability. And the other question I would have is in the specialty innovation space, you know, how are you looking at M&A opportunities at this point in time?
And anything that you can share in terms of activities, spaces that, you know, would interest you or you are currently looking at? Thanks.
Yes. So on the first point, point on the LiqMeds' acquisition, so this is a specialized delivery business which develops difficult-to-do liquid products from products that are not available today. So most of the products are in the nature of when you talk about U.S. regulations and the 505(b)(2) route, and many of them, as I said, first to launch or first to file, for those markets. These, they meet an unmet need for people who need to have a dose adjustment or have dysphagia. The good part of this business is that they've already had important licensing arrangement with the large specialty companies, both in U.K. as well as U.S.
So they work with Rosemont in the U.K. and three big specialty companies in the U.S. who specialize in selling these type of products. So I think from that point of view, there's already a model which is accepted. They have a good relationship and partnership with the companies. They have a very large pipeline which is partly licensed and still under development, which will future also be available for launching as well as licensing out. So we see this business as, obviously, a niche business, a good business which will have a technological differentiation, will be built on the specialty footprint in the US, mostly, and also in many other markets in terms of creating access for it. And our, our, as, our...
Obviously, this is just the first 12-15 months of launch, so it's just the beginning of the company in terms of launch. So the scaling up will happen over the next three years, and we expect because of the nature of this business, and which is to do with mostly the manufacturing, development, and licensing, it would have a significantly high profitability, like specialty companies do.
So, Saion, also the nature of the business as now, as of now is that currently they don't have their front end, as Sharvil mentioned about certain customers and contracts. So the top line is not important. They, the stream of income is three parts. One is the, you know, whatever manufacturing goods they sell, the profit that they make on that.
... But large part of income would come in terms of profit sharing, as well as certain milestone-based incomes based on sales. So these are going to come in times to come, so the whatever number of revenue that you are looking at is actually misnomer, and that should not be, you know, given so much of importance.
Okay. Thanks. And on the landscape for specialty, how are you sort of thinking?
So yeah, on that front, as I said, we are, our keen interest is to continue to look at ultra-rare diseases and orphan diseases in the U.S. We have our currently two products, Nulibry, which is commercialized, and ZYCUBO, which is delayed, but we still believe we have sufficient room to build this rare disease portfolio. We are looking to do further acquisitions in this ultra-rare portfolio, and we have some good leads, so we continue to hope we will be able to exercise more options of acquisition for late-stage products or ready-to-commercialize products in the U.S. So that will be one important aspect of what we will do on the specialty front in the U.S., on the rare disease front in the U.S.
That's our current expectation of what we would hope to build out for, which is buying niche small assets and which are sticky and commercialize them with small commercial infrastructure, both in U.S. and also take them to Europe then.
Okay. And, Dr. Sharvil, I mean, do you have like a three, five-year plan on this? Like, you know, how many assets you would, you know, typically like to have? You already have couple of them, which you have acquired. Anything that will be, you know, from our own pipeline. So how should we think about the... And what, what is the medium-term vision here? Like, when you look at this acquisition, how many products? I mean, how should we think about this particular business, let's say, from a five-year perspective?
So I think for... Yeah, so I think we are looking to at least add 2-3 more products to the portfolio. We have at least two under our own development, which are, which are organic, and we look to continue to look for two or three more assets on the M&A front, as I said, which are late stage or near to commercial approval. So that's what our hypothesis is. I would say the next three years, our target should be that if we can achieve aspirationally $100 million of revenue on that part of the business.
Okay. Thank you, and I'll join back. Thank you.
Thank you. The next question is from Bino.
Hi, good afternoon. Sharvil, is there any IP-related issue around this C-two view? Because there is still a drug substance patent around the salt, which is there, still-
No, we don't have an issue around launch. We are clear for launch.
Okay. Second, you had, in the last quarter itself, mentioned that Revlimid would come down significantly from Q1 to Q2. So is it-
Revlimid.
-just that it has come down, or is it, kind of insignificant in Q2?
There's no Revlimid sale in Q2.
Okay. And, on Asacol HD, anything, any further color from the last call, or are you still expecting a competition in this, in this year, in this financial year?
Yeah. We have built for that, assuming competition.
That's correct.
But we are not aware of it, but we have built for competition.
Understood. Understood. And, finally, just one more product, Mirabegron, where you have an FTF share. One of your competitors have said that, they may be looking at a launch this financial year. Is there any color from your side that you can give?
Yeah, we are evaluating that product, so it is an important product, but I think it's too early for us to make any comments on that yet.
Okay. I'll join back with you. Thank you.
Thank you. The next question is from Surya.
I think, Surya, you may have to unmute.
Yeah, sorry. Hello.
Yeah.
Am I audible?
Yes.
Yeah, thanks for the opportunity, sir, and I'm sorry for this. The first question was the sequential decline on the U.S. business. You mentioned that there is no Revlimid sales in this quarter, right, sir?
Yes, that's true.
So practically, about Revlimid, you had a kind of a thought process that whatever Revlimid revenue that you will be making, it would be distributed throughout the quarter, in the year, evenly distributed. Having-
We never said, we have never said Revlimid will be evenly distributed. We always said it is quarter four and quarter one of the calendar year, financial years.
Okay. Yeah, till FY 2026, that is how it would be, sir?
Yeah.
Okay. Quarter four and quarter,
One.
First quarter.
That is our current thinking. Current, yeah.
Okay. So, since we have completed the first year of Revlimid, and it is a volume-limited one, so now, in the first year, what is the kind of volume that we would have achieved? Is it fair to believe it is more than 6%?
...We are not giving volume. It's a settlement agreement that exists, so we're not giving that kind of guidelines. But it is, as I said, it is a very important aspect of our yearly revenue, and with the increasing market share that we get, we will see an uptick in revenue for Revlimid every—at least for the next calendar year.
Okay.
And-
A related question, sir, is, although the Revlimid number is not there, which was in the previous quarter, almost like $70+ million or something like that. Despite that kind of revenue stream not there, which is a such a high margin business, your gross margin in this current quarter, without Revlimid, almost maintained the same number what you had achieved in the previous quarter. So what is supporting this kind of number, and how sustainable the base business achieving this kind of gross margin?
So as I said, it's a mix of our base business and new product launches, and overall product mix with lesser realization from consumer health in this quarter because of their seasonality. I think all of that has led to a good, I mean, a decent GC margin. But Nitin, you can add something.
So, input cost reduction has also helped, especially in Zydus Wellness.
Yeah.
They've also taken selling price increase in Zydus Wellness. Plus, the new products that are launched, in the quarter in U.S., they are at better margins. So it's a business mix and product mix, both helping us, as well as cost reduction.
But don't you think that this Revlimid is such a significantly influential gross margin product? So that means, is it fair to believe, sir, once we again see the Revlimid number, which will be again elevated versus last year, then our gross margin profile will really be meaningfully better than the current number what we have?
So if you do not see Asacol competition, then what your hypothesis is right, but we are building for Asacol price erosion. So then, we'll have to see how much we can compensate.
Okay. Okay. Fine, sir. My second question is on the, this LiqMeds. Sir, is it a loss-making business or it is something on the, it is on the verge of turning around, something like that?
It's not a loss-making business.
So we already clarified that it is EPS accretive from beginning. So it's a profit-making.
Okay. Because somewhere I was seeing the reporting, which was showing that the net worth is negative yet.
That, you know, we'll check the number. Maybe because of carry forward, you know, past losses, because they are spending and developing the products initially. So there are spend and the, you know, incomes is, you know, back end in terms of timeframe.
Okay. Okay.
As I said, this company is going to the business case for today, it is development for partners and licensing. And they have a cost plus profit share plus milestone-based events where they earn margins, and these are specialty products, so the margins are very high. So this will be a sufficiently very high profitable business. Not a sales top-line business, but a very profitable business going forward.
Okay.
This will also help our branded specialty play in the U.S., maybe not always directly, but through partners also.
Okay. So that means with this integration, this, this, base will not going to work for, customers anymore. It is the captive, service opting kind of thing. That is the right understanding, sir?
No, no, we are partnering with some of the products. We don't have capability to sell ourselves, and we are not present everywhere, so it will be mostly the current business model only. And also we will use these products to file in our developing markets and other markets where these are important products also. So those we will do it ourselves, also. But currently lot of the current projections of revenue that we have made are mostly through licensing.
Those are already contracted.
Which are already contracted out.
Okay. Okay. Yeah, thank you. And, just last one question, sir, on the R&D side, whether you have mentioned the $100 million kind of spend that you're targeting for the specialty initiative?
I said $ 100 million revenue, not spend.
$100 million revenue in-
Somebody had asked a question that midterm, three to five years, what do you see the scale up? So we said for the rare disease portfolio, our aspiration is that over the next three years or three to five years, we build a $100 million revenue.
Okay, okay. So this is, yeah, this is optimistic one. So in fact, so on the R&D side, so whatever the spend that we are making, how much is that, how much of that is, for specialty, currently? And, what is the kind of ultimate game plan here, sir, in terms of investment, creating capacity, capability, and what timeframe that you are targeting to really build a kind of, sizable portfolio and, a meaningful base over the next five years, let's say?
So today of our R&D spend, about 50%-55% of our spend is on our generics portfolio, which is also differentiated and complex.
Yeah.
And the remaining 45% is what we spend on our NCEs and biologics and vaccines. And so I would say over a period of time, the generic portfolio will not grow, and the growth will be seen in the NCE biologics as we add more, NCE development programs for global development. So I would say the mix would change from higher based on the specialty versus the generics.
Okay.
On the R&D efforts.
Okay, okay. And till the time our R&D spend will be streamlined like this, currently 8, 7, 8% outlay?
Yeah, we are saying around a 7%-8%, and over a period of next 3 years, we'll look at around 8% on revenue.
Sure, sir. Yeah. Thank you, sir. Thank you for answering all my queries.
Thank you.
Wish you all the best, and happy Diwali to you.
Happy Diwali.
Thank you. The next question is from Akshat Gupta.
Hello?
Hello.
Yes, sir. I see there has been a reduction in the business of U.S. formulations.
Sorry?
We, as after analyzing the quarter-on-quarter numbers, we see there's a 24% decrease in business of U.S. formulations.
Yeah, because we don't have Revlimid sales this quarter.
Sir, what about the margins?
It's already reported, the margins-
Gross margins are 66%+.
The quarter-on-quarter margins have been reducing, sir.
That's because of Revlimid. I mean, the Revlimid last quarter was there versus this quarter.
Okay. Thank you.
Thank you.
Yeah.
The next question... Akshat, do you have one more question?
No, that's it.
Okay, thank you. The next question is from Kunal Dhamesha.
Two in a row.
Thank you, sir, for the opportunity again. So on the asset call, while we are building in one competitor-
Mm.
Now that our product has become reference product, have we seen any more Para III filer, you know, for that which would come in future, not just in this year, but probably in future?
So there are people who have filed who continue to work on it, so I don't think there's any patent left. But as I said, we have assumed one competitor and potentially another competitor in the end of the next calendar, current calendar year. So we have to assume the worst, but so far we have no idea when we will see competition.
Sure, sure. And, can you provide update on Saroglitazar trials for PBC and, NASH in the other developed markets?
Yeah. So on PBC for Saroglitazar, we hope to complete all our recruitment this financial year for the recruitment of the trial, and so we are on track to do that. And then obviously subsequently follow up and then filing. And for NASH, phase 2B is still ongoing. It's a longer phase 2B, so that is still some time away. So we still need to recruit another 130-150 patients.
Sure. Yeah. Sir, would there be any change in strategy from NAFLD or NASH perspective, given the weight loss drugs gaining momentum? Because my belief is NAFLD, NASH are directly linked to the higher weights, et cetera.
So, again, for our current focus on commercialization and plan is for Saroglitazar in PBC and not in NASH. NASH is still a long way out for us in terms of the developed market strategy. And, I mean, we have to see how the therapies do get developed. Yes, these products are also important, but maybe in the future there will be need for not only this, but combinations. So I don't think a single drug or single molecule will exist to solve for a particular indication, like NASH and NAFLD, which is very complicated, with multiple issues. So I would say there is still enough opportunity for that segment, but we are still far away from any commercialization capability for NASH, in the medium to long term.
Sure. And the $100 million target that we have given for specialty, would that include, kind of, PBC approval for Saro?
No, the $100 million aspiration that we have set for our rare disease business is not to do with Saro.
Okay. So it's over and above whatever we do on Saro?
Yes. No, Saro is our orphan, is our rare, orphan disease platform, which is a different, business unit that we are targeting.
Okay. Perfect. And, sir, given there is, while you have suggested that, Q4, Q1 is where Revlimid would be, you know, but would we- would you be comfortable giving us, some direction as to where could we see our U.S. revenue for the next couple of quarters? We have said that it will grow, but, we know what that growth could look like based on the products that we have in, you know, portfolio.
So as I had said, for this financial year, we do, do expect a double-digit growth for the US. And as, as we have new launches, significant important new launches, as well as the limited competition products that we hope to continue to launch, we would... Our, our expectation is to continue to grow the US generics business.
Yeah. And overall, within U.S., you know, have you seen any improvement in price erosion, you know, the competitive dynamics? You know, because the shortage environment continues there.
... No, I think it's similar, so I don't see any drastic change in the market.
Okay. So what is, what would be our price erosion for this quarter?
We don't give price erosion for the quarter, but overall, we are expecting a mid-single digit price erosion.
Mid-single-digit, okay. Because historically, we have said, like, almost 1.5%-2% sequential price erosion, which kind of adds to, high single-digit price erosion, which-
Yeah. So I think that's our best estimate, right? And it all depend on the portfolio.
Yeah.
When we see competition on Asacol and others, then obviously, depending on that, the erosion can be more. But on a normalized basis, we are seeing mid- to high-single-digit, depending on the portfolio.
Sure. Sure. Thank you, sir, and all the best.
Thank you. Requesting everyone to limit their questions to two. The next question is from Vishal Manchanda.
Thanks for the opportunity. Did we get any benefit from PLI incentives during the quarter?
Yes.
Yes, in the quarter, we have INR 40 crore accrued in this quarter for PLI scheme.
Was this booked as part of other operating income?
Yes.
Okay. And second, on LiqMeds acquisition, can you share how many products have been commercialized so far?
There are 16 products that are approved in the U.K. All are not commercialized yet. There are 5 505(b)(2) products approved in the U.S., which are getting commercialized. Some are commercial, some are to be commercialized, and they have multiple products filed and to be filed.
Any guidance in terms of how many approvals we can expect in the next, say, two years from LiqMeds?
I don't think we'll be able to give that right now, but, as I said, currently, we, in the next three years, planning-wise, most of the products are developed or filed. So, the visibility is much clearer for over the next two to three years. But the future pipeline, we'll still need to come back to you on that. But there is a very large pipeline, so the main is how do we prioritize and, file these products.
Among the products which are commercialized, so these are early stages of launch, okay, and so they can ramp-
Yes.
-up much?
Yeah, these are early stages of launch, and these are all specialty products, so these are not generic substitution products.
Okay. Okay. And just, one final, you talked about a, launch around REMS, so a few REMS product that you were expected to launch. So any, any guidance on, guidance there? Can we expect this in the next two quarters?
I think we are about to launch or launched one already, and the second will launch in the last quarter or the first quarter of next year.
Which is the one you already launched?
Uh, isotretinoin.
Okay. Okay. Got it. Thank you.
Thank you. The next question is from Nitin Agarwal.
Now, in the U.S. business, when we look at the sequential decline, this decline is entirely attributable to Revlimid, or there are other parts of the business which also contribute to the decline?
No, the large decline is because of Revlimid. With new products and base business, we actually improved from the base of Revlimid.
Because, you know, the question I ask you is, we have almost like a $70 million delta on a Q-Q basis. You know, so are we suggesting that Revlimid was higher than $70 million on a Q, you know, is, in a Q from... Is that the, is the right inference to make?
Yes. Almost. Yeah.
Okay. Should we then, you know, if you look at, for example, the last year, we were at about $250 million of business. You know, obviously, there were none of these Revlimids and all in the base. We've had a reasonable number of new launches coming through over the years, over the last few quarters. We still are kind of around the same level, right? $215 million becoming $225 million in the current quarter. So how should one look at, you know, this, this progression of this business, X of, X of the contribution, probably from the likes of Revlimid?
So, as I said, overall, we believe that, I mean, we'll—this year, FY 2024, we'll see a double-digit growth for our U.S. business, and that will be our endeavor, that with new launches, we continue to do that. The only point is, it's wrong for us to remove Revlimid. Revlimid is not a one-year phenomenon. It's already been there for two, almost two calendar-
2026 .
two years, and it'll continue at least for the next two years. So this is with inclusion of Revlimid, which will continue every year.
Secondly, on C
Hello? I think we lost you, Nitin.
No, I can-
Yeah, we got back. Yeah.
So I'm saying, you know, on the India part of the business, you know, do we have now visibility of maybe an in-line market or higher than market-comfortable market, in line to above market growth on an ongoing forward basis from here on?
Yes. We will, we will grow in line with market. And we'll now, I think with the better quarters, I mean, better growth in October for the market, we hope to have a better, much better growth in the coming quarter also.
Last, if I can squeeze in, on the cetrorelix, when are you looking to launch these products?
Next financial year.
Do you have, in your experience of, any sort of past experiences where 505(b)(2) launches like these have happened, and companies who've done that have been reasonably successful in their... What kind of success they've had in such launches in the past?
So it has been. I won't say there have been any meaningful big successes on oral 505(b)(2), so it's something new for all of us, so all the industry also. But yes, we are hopeful that we should aspire for 8%-10% market share, to begin with.
Okay. Thank you very much.
Thank you. Requesting all participants to refrain themselves with two questions only. The next question is from Bino.
Hi, thanks for the call. From your press release, I can see that there are two biotech products in which, in one of which you have completed a trial and one for which you have finished recruitment. Are these Phase 3 trials?
Yes, these are Phase 3 trials. One we have finished and filed, and one we have just finished recruitment and hope to file in the next, last quarter.
Okay. I assume these are in India, and in that case, are-
Yes.
They more like, kind of like biosimilars, or is it a completely new bioproducts?
Yeah. So these are biosimilar, and these are... When I said the clinical trials, these were done in India for India market-
Okay.
and developing countries.
Okay. Biosimilars, basically. Okay, great. Thank you.
Thank you. The next question is from Damayanti Kerai.
Hi, thank you for the opportunity. So my question is on India business. So, you mentioned you'd like your India business to now grow at least in line with the market. So, if you can talk about the key growth drivers for India from here on, and also, what is your expectation for Desidustat, which seems like an interesting product in your portfolio?
So we continue to reiterate that we will grow in line with the market. The strategy is going to be driven by our growth booster brands that we have, which will drive large part of the growth for the company, and which also include the innovative products like Lipaglyn, Bilypsa, Oxemia, which is Desidustat, and Ujvira, and also adding few more products in the next coming year in terms of differentiation like Nitroglycerin and others. So those innovative products will add a significant uptick to our overall growth story while we continue to maintain and grow on our base business also.
I would say near term, as I already reiterated, with the improvement in market, in the segment in October and going forward, we would see a better uptake on growth for the India business. With a larger base being built on these innovative products, we would also see better-than-market growth over a period of time.
Okay. And in terms of sales, sales team, like, are you like broadly okay with the current team strength, or you plan to add on more to improve reach and penetration, et cetera?
So in next financial year, we are adding, we are increasing our footprint.
It will be next.
But not in a drastic manner, but in a measured manner, we will, we would add, add field force, feet on street, in the coming financial year.
So how many MRs right now in your team?
6,500.
Okay. My second question is on the U.S. business. So, like, you have seen good pickup in approvals, launches, et cetera. So in your current U.S. portfolio, if you can mention, like, how much sales is contributed by, say, non-oral solid, some differentiated products, which will be, say, key drivers going ahead also?
So the U.S. business of generics is a basket business which has oral solids, topical products, like injectables and complex products like suppositories as well as transdermal patches. So I don't think we have any segment way of doing this business. It's a portfolio business that we build, and that is how the generic market also functions. So I don't think we can give dosage-wise breakup, but as I said, it constitutes of a... The business is constituted of all of these dosage forms.
Okay. And all, going ahead also, like, it depends on the nature of the product, rather than the dosage, which will determine its-
Yeah. Yeah, so there will be always a mix of all of these, which I mentioned to you.
Okay, thank you for your answers. I'll get back in the queue.
Thank you. The next question is from Charul Agrawal.
Hi, can you hear me?
Yes.
So I wanted to understand more about the co-marketing agreements for the India business, for the innovative products that you have recently signed. So what would be the rationale for these, given Zydus already has a strong field force presence?
... So I think, both. First starting for, with Saroglitazar, I think it is to create a larger access. We have a certain reach, and capability and capacity to reach a certain number of patients. And with the indication coming through for NASH and NAFLD for Saro, and the only drug to be approved for this, we do see that potentially adding more patients, and more physicians, we're creating awareness for more physicians is a, is a need for us. And from that point of view, we did go through a whole process of identifying the key partners. And, so far we have been able to have two. One for Desidustat and one for Saroglitazar. We hope to add one more partner, very soon.
Sir, what would be the agreement like in terms of profit share or would it be a fixed fee? How would it be like?
It's a typical out-licensing agreement like others that exist in India.
Okay. Sir, on my next question on OpEx. You did mention that the cost could moderate over the next quarter, but could you throw more light on the nature of these expenses?
No, we only talked about other expenses on a quarterly basis. What is the base? So we said that, excluding R&D spend, the quarterly base will be INR 850 crore-INR 900 crore.
Okay. And sir, what were the lower expenses due to QoQ?
Savings, because of higher input costs last year versus this year, and product mix also has helped better margins.
I think she was asking about other expenses reduction. As I said, other expenses they are affected by two major factors. One is the R&D spend, which is not uniform across the quarters. Other is Zydus Wellness related spend, which is a seasonality in nature. If you remove these two, which are going to be different for different quarters, the normal base will be INR 850 crore-INR 900 crore. And that variability is also because of, you know, legal and professional spend and other spend, some spend which are related to sales or production, so which again vary from quarter to quarter. So that range, you know, gives you ballpark number.
Thank you, sir. I'll get back in the queue.
Thank you.
Thank you. The next question is from Tarang Agrawal.
Hello. Hi, am I audible?
Yes.
Hi. Three questions from me. One, you know, this is with reference to, you know, onboarding, Mr. Patel in North America. You know, what really drove this decision? And, you know, considering that you've been in the market for almost two decades now, how are things likely to change, with him coming on board?
So our U.S., as I said, we have two important geographies that, we said we have a strong focus on. Now, obviously, over the last 15 years, we have built a good U.S. generics business, but as you, as we move forward, we have, an intention to build a rare disease portfolio. We hope to build a Saroglitazar and build a orphan specialty business in the U.S. We have an animal health business. We have Viona Pharmaceuticals. We hope to explore Canada and enter that market. So looking at all of that, I think there was a need to consolidate, how we run the operations in the U.S., and we have been looking for somebody to come in and look after all as a consolidated North American business.
So that was the main reason for us to do that, that we are able to harmonize, consolidate, and grow this business. So Punit brings both the understanding from the customer side, which is important, but also brings in his understanding of specialty business in his earlier efforts that he has put both at CVS and his earlier job. So I think that, that was the main reason for us to see that how do we continue to build our generics platform, but also all these other new platforms and consolidate the leadership in the U.S.
Okay. Got it. Second, you know, my sense is there was some Revlimid in the base quarter of the previous financial year. So would it be safe to presume that the U.S. business must have grown by almost 15%-18% on a constant currency basis?
Definitely.
Okay. And last, how many launches could we see in U.S. over the next half year or say, next four quarters?
Next, how many quarters?
Next one year from today, or next half year, till March 2024.
We hope to launch anywhere between 30-40 products every year. It varies, but at least 30 products is something that we would continue to launch in the next 12 months also.
Okay. Thank you.
Thank you. The next question, the next question is from Saion Mukherjee.
Yeah, thanks for the follow-up. Just I wanted to, from the U... In the U.S. generics, you know, you mentioned 30-40 products, but is it possible to give some granular, like what kind of products we should sort of look forward to over the next, you know, three years? And just one specific one, you got a approval for a transdermal, I think a few months back. Just wanted to confirm whether that's launched or when is it going to be launched?
So yeah, we are launching two transdermals, and potentially. By the end of this year, calendar financial, we would have two commercialized transdermal products beyond rivastigmine that is already launched. And going forward, we have obviously plans to launch two more on the transdermal franchise. We also have some important launches coming, both where we believe we will be exclusive going forward. I think almost 2025, 2026, 2027, we do believe we have one exclusive product to launch every year. That is what our current belief is. But obviously it has to pan out in terms of both IP and litigation and other areas. But we do have a sufficiently exciting basket of products to be launched.
In the near term also, we do have six to 10 products, which are, you know, in the $8-$10 million plus range kind of value. So, it is a good basket of products that are there scheduled for launch, and some of them being very important as well.
Okay. And sir, any comment you have on the GLP-1 portfolio, which you have filed? Anything you would like to share? Is that a opportunity you see over the next couple of years?
I would say not in the immediate future, but this is definitely a very important opportunity, and we do believe that we are also among the few companies who have a good position on this. So it will be an exciting launch, obviously beginning with India and emerging markets, but then moving into the developed markets. But, I don't think it's a short-term opportunity.
Okay. In India, sir, when would these opportunities play out for you?
I think the patents, post-patents, I think it's 2026 is when the patents go off, I think, in India and some other markets.
I'll get back to you, Saion, on that.
Okay. Thanks.
Thank you. The next question is from Kunal Dhamesha.
Just one clarity, sir. I believe that we had another product called generic Trokendi XR as well as a good contributor in quarter one, which would have also come down and,
Yes.
- would have been. So then the $70 million decline cannot be given to Revlimid, right? There'll be some Trokendi because it was-
That was in quarter four, bigger, because that was their month. Then quarter one, there was competition already.
Okay. So then, sir, Revlimid decline would be less than $70 million?
So, almost, not if not 100%, 90%+, you know, decline is related to Revlimid only.
Okay. Thank you, sir.
Thank you. The next question is from Surya Patra.
Yeah, so just a query on the Mylab acquisition. So what is the thought process there, and where it fits to our overall growth strategy?
We haven't acquired any majority stake in Mylab. We have taken
Six and a half.
6.5% equity stake in Mylab.
Correct. But any thought process going ahead there?
Yes. So I think one strong belief as a company and as a broader portfolio, that we say that beyond being a pharmaceutical company, how do we bring better solutions for patients, beyond the pill? One area which is very interesting for us is at-home testing and point-of-care devices. And I think Mylab is pioneering in that area, in both of these areas and completely homegrown, which also brings efficiencies and cost efficiencies. So we believe we will find an important area to work on creating access for these types of PCR point-of-care devices, which can revolutionize the way molecular diagnostics and advanced diagnostics happens for many of not only the current conditions and issues, but future diseases as well.
That's where our focus is going to be, and that is why we have partnered with them to bring this kind of portfolio to the physicians and the patients.
Okay, okay. But don't you think that is a kind of relatively generic in terms of in terms of the earning potential, in terms of the competitive landscape that is there in the market, and whether it is targeted for the domestic market or you are thinking taking to the other market all as well?
No, it's for domestic, and it is not at all generic. The large diagnostic testing places are generic in nature. These are molecular diagnostic tests which are highly specific and sensitive and in real time, and where you can do it at home or point of care at a clinic. So this has not been done in India yet, so there's nothing generic about it.
Okay. Sure. My second question is on the... Sir, how big is the injectable portfolio? We have certainly seen some couple, few approvals from the injectable front targeted for U.S. market. But right now, at what level that we are and, how important this, this segment could be for, U.S. business going ahead?
So the generic injectable segment is a very important part of our overall generic strategy, and it will continue to be critical over the next... for us to grow in the U.S. But it is just one part of our overall product mix that we do. So I would say, obviously it is growing and it's small, but the most important part is that we have a franchise that is in injectable, complex orals, suppositories, transdermals, topical. So the whole franchise is going to be important.
Okay. Other than the oral solid, then including injectables, what is the pipeline it would be still looking like, sir, for you?
So as I said, the pipeline constitutes of orals, injectables, inhalation, transdermals, topicals, and some suppositories.
I mean, sir, in terms of number pipeline, can you say?
We have more than 100 products that we need to file.
Okay. Okay. Sure, sir. Yeah. Thank you.
The next question is from Kunal Dhamesha.
All my questions are answered. Thank you.
Okay, thank you. The next question is from Tarang Agrawal.
Yeah, hi. Just one quick question. How are you looking at the Zydus Wellness business, purely, from where it stands today? I mean, on a consolidated entity level, it's, it's a fair, big drag on the return metrics. So just wanted to get your sense in terms of how you're looking at this business.
So I think from our India strategy point of view, Zydus Wellness is a very integral part of our strategy and future profits and growth. And I would say, obviously, in the last two to three quarters, we have had issues on margins because of cost escalation that happened. But I think as you see in the last quarter, that has corrected, and the gross margins are back to the original gross margins that it had. So one part of the problem gets solved in terms of the margin profile. And it's been a tepid quarter because of low demand, as you can see for most of the FMCG. But going forward, it is a business that will drive double-digit revenue growth and with improvement in margins, also profit growth.
For us, it's a very integral part of what we plan to do in terms of the overall India business point.
Okay. Thank you.
Thank you.
Thank you. I now hand the conference over to Dr. Nayak for closing remarks.
Thank you very much, and we look forward to interacting with you again in the month of February, when we declare the next quarter results, and wish all of you a very good evening, and wish you a very happy Diwali and a prosperous new year. Good night.
Thank you. On behalf of Zydus Lifesciences Ltd., that concludes this conference. Thank you for joining us, and you may now disconnect your lines and exit the webinar.