Zydus Lifesciences Limited (ZYDUSLIFE) Earnings Call Transcript & Summary

Good evening, ladies and gentlemen. Welcome to our post results teleconference for the quarter ended June 2021. I do wish that you and your families are keeping safe and well. For today's call, we have with us Dr. Sharvil Patel, Managing Director; Mr. Nitin Parekh, Chief Financial Officer; Mr. Vishal Gor, Senior Vice President, Corporate Finance; and Mr. Alok Gur, Senior Vice President from the Managing Director's office. This quarter on, we have started the practice of sharing quarterly results, investor presentation, which we have posted on our website and filed with the stock exchange. I'm sure you would have received the same. Among our 2 key markets, India and the U.S., the contribution from the India geography has increased. This has offset some of the challenges in the U.S. during the quarter, resulting in a healthy double-digit growth in revenues and in EBITDA with an improvement in operating margins. Coming to the quarter, despite the onset of the second wave of COVID-19 in India and the consequent challenges posed by that, our business grew in double digits, aided by strong performance in the India geography. With that, let me take you through the financial numbers for the quarter gone by. As you are aware, the transaction of sale of our animal health care established markets undertaking of Zydus Animal Health and Investments Limited was completed recently on the 14th of July 2021. The consolidated financials for the period ended June 2021, up to the PBT level do not include the financials of the Animal Health business. And financials of the previous quarter and previous financial year have also been restated to correspond with the figures of the current reporting period. Net profits from health -- for all the periods having shown separately as profits from discontinued operations in the profit and loss account. During the quarter, we posted consolidated revenues of INR 40.3 billion, up 15% year-on-year. Consolidated EBITDA improved during the quarter and stood at INR 9.33 billion, up 18% year-on-year. EBITDA margins for the quarter stood at 23.2%, which is an improvement of 140 basis points on a quarter-on-quarter basis. Various process simplification and efficiency enhancement initiatives aimed at optimizing the costs resulted into an improvement in EBITDA margins despite the inflationary ratios. Consolidated PAT for the quarter was INR 5.87 billion, up 29% year-on-year. Our India geography, comprising of human health and consumer wellness business, which contributed to 50% of the consolidated revenues during the quarter witnessed a very strong growth of 43% on a year-on-year basis and registered sales of INR 19.4 billion. The U.S. geography, comprising of generics and speciality portfolio posted sales of INR 14.5 billion during the quarter, down 4% quarter-on-quarter. Our emerging markets business grew by 17% on a year-on-year basis and posted sales of INR 2.77 billion. On a sequential basis, the business grew by 11% during the quarter. Now let me take you through the operating highlights for the first quarter of FY '22 for each of our business lines. Starting with our human health business in the India geography. The pharmaceutical business market in India registered a healthy growth of 37.2% during the quarter gone by, aided by the lower base of the previous year and contribution from the COVID portfolio. In line with the market, our business also registered a strong growth during the quarter. Overall, our human health formulations business posted sales of INR 13.57 billion during the Q1 FY '22, up 64% on a year-on-year basis. The growth was supported by both the core portfolio as well as good performance of the base business. Branded generics business grew by 67% on a year-on-year basis during the quarter. We gained market share in the anti-diabetic, anti-infective and the neutraceutical therapeutic areas during the quarter vis-à-vis the corresponding quarter of the previous year. Going forward, with the reduction in the COVID-19 cases across the country and relaxations of restrictions, we expect the demand for medicines to normalize due to increased footfalls in the doctor clinics. During the quarter, our consumer business witnessed a strong growth in 5 out of 7 brands that resulted in an overall 10% growth on a year-on-year basis and revenues of INR 5.9 billion. The sum of seasonal brands, Nycil and Glucon-D, could not capitalize on their full potential due to a short summer and lockdown in many states. With markets opening up, we see strong demand across channels. Now let me take you through the performance of our U.S. formulations business. As mentioned earlier, the business saw a sequential decline in revenues during the quarter gone by. Reduction in cases of supply disruption in the market resulting in limited onetime opportunities and pricing pressure in some of our products led to this decline. However, despite the increased competition and pricing pressure, our U.S. generics business to grow the overall volumes during the quarter. Recently, in the month of July, we received the final approval for Fulvestrant injection, which is the first approval of a complex product from the biologics manufacturing facility. This product got the approval in the first review cycle by the U.S. FDA and was approved in less than 10 months of filing. Recognizing the importance of digitalization and advanced analytics in improving health care delivery offering better customer experience and building responsive back end, we have taken multiple digitalization initiatives in our human health formulations and consumer wellness business in India and also our manufacturing operations. In the human health formulations business in India, we are working on a platform technology that will connect the entire value chain to drive quality, productivity, operational efficiency resulting in enhanced patient centricity, better prescription engagement, comprehensive disease management and an improved health care delivery experience to all the stakeholders. On the consumer business front, the digitalization initiative will help get real-time demand visibility across channels, market trend analysis through predictive modeling, efficient management of inventory, better ROI on trade spends and also enable close monitoring and governance of other functional KPIs. On the manufacturing operations side, we are working on the use of advanced digital and analytical tools that will enhance overall compliance and efficiency to simplification, resulting in increased throughput by unlocking equipment effectiveness, productivity by avoiding redundancies and adopting lean work practices to optimize costs. During the pandemic, we saw opportunity to completely relook at our entire operational spend and initiated the process of zero-based budgeting in our major business, mainly human health formulations business in India. This initiative will help optimize both direct and indirect spend and build internal capability to attain sustained savings over time. The manufacturing operations and zero-based budgeting initiatives put together are expected to improve our operating margins by 80 to 100 basis points. Now this concludes the business review. I will now request Dr. Sharvil Patel to take you through the progress and initiatives in our innovation program. Over to you, Dr. Sharvil Patel.

Thank you, Mr. Nayak. And good evening, ladies and gentlemen. As you all know, continuing with our efforts to combat the COVID-19, we had applied for an EUA to the office of DCGI for the ZyCoV-D vaccine, with an interim Phase III clinical trial efficacy data for the 2 milligram dose study. The trials were conducted in over 28,000 volunteers at more than 50 clinical sites spread across the country, and during the peak of the second wave of COVID-19, reaffirming the vaccine's efficacy against the new mutant strains, especially the Delta variant. This was also the first time that any COVID vaccine has been tested in the adolescent populations in the age group of 12 to 18 in India. Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. We have also submitted the dossier of ZyCoV-D vaccine for an EUA to DCGI with a trial data for the 3-milligram dose study also, which is a 2-visit vaccine. On the NCE front, recently in the month of July, we are very happy to say that the EMA, the European Medical Agency granted orphan drug designation to saroglitazar magnesium for primary biliary cholangitis indication. ODT status provides us with an exclusivity for 10 years if the treatment gets approved. PBC is a disease with a global prevalence of approximately 40 cases per 100,000. Women are much more likely to be affected by PBC than men, and the incident increases after the age of 50. Across the world, PBC primarily affects an estimation -- estimated 1 in 1,000 women over the age group of 40. Global market for PBC treat is expected to grow at a CAGR of 36% from 2018 to 2026, and is expected to reach approximately $11 million by 2026. Approximately 40% of the patients are either known or partial responders to the current modes of treatment, resulting in a highly undeserved patient -- underserved patient population. We are hoping that saroglitazar will solve for one of these critical outcomes and become a successful product as we move forward. In India, we received an approval from CDSCO to initiate Phase I clinical trial for a novel multi-dose antimalarial molecule ZY19489. This molecule has already been trialed in Australia. Coming to the biosimilars. During the quarter, we launched trastuzumab emtansine, the first ADC biosimilar and a highly effective drug for the treatment of both early and advanced HER2-positive breast cancer under the brand name, Ujvira. The drug has significantly reduced the cost of treatment by almost 80% for all patients. Talking on our 505(b)(2) and specialty initiatives. During the quarter, we received a response in the U.S. FDA against our pre-NDA meeting for a pain management product. NDA for this product is expected to be filed during the current financial year. During the quarter, we completed 6 in-licensing deals, 5 out of the 6 products are expected to start contributing to the revenues from FY '23. Cumulative number of such in-license products now stands at 24. Out of all the in-licensed products for 2 products, we are likely to hold an exclusive first-to-file status and are likely to have a 180-day exclusivity upon launch. Thank you. And we'll now move over to the Q&A session. Over to the coordinator.

[Operator Instructions] Our first question is from the line of Tushar Manudhane from Motilal Oswal.

Just on the in-licensing deal you alluded for revenue contribution from FY '23 onwards. Any further color on this in terms of further quantifying how much this revenue contribution can be?

So I think most of the in-licensing deals we have done are where we have gaps in our portfolio or where we may have lost some opportunity on first-to-file. So the in-licensing opportunity is generally products which are very niche or very -- products which have low competition. So they all have a significantly good commercial potential than any of the normal molecules. So they are obviously the high-value products. Exact value is not possible to give in terms of the next 2 to 3 years forecast for that. But some of them do fall in the complex injectable space and some in the oral space. As I said in my call also that 2 of these products is also where we have got 180-day exclusivity potentially. So they are all meaningfully large value products.

And these will be manufactured at our...

So largely, many of them are manufactured by the company whom we license from because they are complex in nature, either the API or the formulation. A few of them, we will do manufacturing ourselves. But by and large, many of them are sourced through the third -- licensing.

And just lastly, how much would be the share of COVID related revenue for the quarter either in the -- in the human health business?

I couldn't understand the question.

For of share of COVID-revenue in the human health business for the quarter gone by?

So large part of the revenue -- majority of the revenue was obviously was remdesivir. Minus remdesivir, our growth was 35-plus percent for the branded formulation.

Our next question is from the line of Kunal Dhamesha from Emkay Global.

So first, on the U.S. business, we said the weakness is attributed, one of the factors is onetime buy. So that -- was that -- I think that should be positive impact, right? So was that in this quarter? Or the last quarter, we had some onetime buy, which did not recur in the first quarter?

So onetime buy, we have been seeing it for many years last -- in the last couple of years because of disruption in supply chain. In the last 6 months, we have seen the onetime buys have dried up because there is very little issue with supply chain in the U.S. So we haven't seen any meaningful onetime buys in the last 6 months.

Sure. And secondly, I think we have launched like 4 products in U.S. vis-à-vis our target was somewhere around launching 30 to 35 products. So are we still on track to achieve that?

So in the U.S., we still do expect to get close to 50-plus approvals, some being tentative and we will still achieve 30-plus of launches.

Sure. And secondly, on the vaccine opportunity. Now that around 55% of the added population has been vaccinated with at least 1 dose and every lost month is kind of reduces the remaining market by at least 20%, 25%. So how do you see this opportunity now in the adult market as well as in the adolescent? And on the adolescent front, have we also submitted for emergency use authorization for our vaccine?

So on the second question, yes, we have submitted for EUA for the adolescent population, and we are also hoping we will see approval for that, and we'll -- as soon as we know anything more, we will apprise everyone about it. With respect to the opportunity for COVID, our current capacities that we are fully -- which we fully manufacture ourselves is at the max between 10 million to 15 million doses monthly, which is not very large in terms of the overall need of the vaccination. So even at the adult population, I think for us, I don't think the difficulty will be being able to secure the business for the quarter -- the manufacturing capacity that we have. So we still feel we should be able to supply whatever we can make because we are not -- I mean, you're talking about INR 1 crore doses or INR 1.5 crores, which are not very large in the overall requirement point of view.

Sure. And if I may squeeze in the last one. In terms of vaccine manufacturing, have we started stockpiling because I believe our plant was supposed to be commercialized somewhere in July. So have we started stockpiling in the anticipation of approval? Or we'll start manufacturing at commercial scale after approval?

So in our smaller facility, we have started manufacturing commercially for stockpiling. In our new facility, the activities are starting as of this week.

Our next question is from the line of Surya Patra from PhillipCapital.

My first question is on the U.S. front. Any specific reason that we see a kind of decrease in...

Your voice is not clear, sir.

Hello? Is it audible?

Yes, a slight disturbance, but yes, that's sort of now.

Okay. So I was just asking about the U.S. business. Any specific reasons that we have seen a kind of sequential correction in the U.S. business because I know that the previous quarter was not a great quarter in any manner about the flow sales contribution? So hence, that was more even for a kind of a sequential correction, although there was a kind of issue of pricing pressure. And given that, what is the kind of outlook that you are having for the full year in U.S.?

So in the U.S., 2 things which we spoke about in our conference call, 1 is there is a lot more competition that we get to see on established products and new products with approvals that have come through, both from existing and new players. So that is something that has definitely happened to the market where you're seeing far more competition and base. Second is that there have been least supply disruptions during the last 1 year. And that also means that what we used to get to the opportunities of onetime sales by being able to supply products, which are in shortage, that issue has come down for the oral drugs. So that's the second part by which we see some gap. And thirdly, we have said that for the -- because of the lower activities at the prescription level, some of the products, the prescription volume have come down, which correspondingly means that the buying also reduces. So those are some of the things that have happened, which has led to this. For us, from an annual point of view, we are still looking at a low single-digit growth for this year. And if some of the critical new products succeed, we can see some better traction on that. So that is our current estimate. In terms of the next 2 to 3 years, we believe that both transdermal and our specialty injectables and some of the complex oral solid products will allow us to then scale up from the current levels of what we are at.

Okay. Second question is on the COVID portfolio and the anticipation from the vaccine [indiscernible]. So you have obviously indicated about it already. But I'm saying, let's say, given the recent developments about the approval for the combination of Covishield plus Covaxin, the approval of J&J's single dose. And your recent -- just the commentary to the earlier question that your expectation of INR 1 crores to INR 1.5 crores kind of per month target, that is anyway can be achievable anyway. So that means -- are you kind of moderating our expectations here? So my second question was on the vaccine opportunity, sir. So I was saying that given the recent development about allowing or approval of the Covishield plus Covaxin kind of mix in India and the single dose of J&J. And sure, right now, you have mentioned about your expectation of a INR 1 crore to INR 1.5 crore per month kind of volume. So whether that is a kind of moderation from your earlier expectation that you were thinking about achieving INR 3.5 crore kind of level by December or so. So anything on that front?

So I think your question, I understand, but I think you're mixing 2 things. When I say INR 1 crores to INR 1.5 crores, that is monthly. And what we had said INR 3.5 crore was till December. So we haven't moderated our stance yet. We believe that currently, we -- whatever we will be able to make, we can find an opportunity of market for it in India. And obviously, there is market outside. But currently, let's focus only on India. So we don't see any concern on that. If you look at the manufacturers today in India, Covishield has a very large manufacturing capacity. But other than that, there is nobody who is achieving more than INR 1 crore to INR 2 crore, and any of the approved vaccines have not reached commercially availability at all in India. So I think in India, we still require a lot of vaccines. And for us, we believe that with whatever understanding we have, we have a very -- currently a very strong demand for our vaccine, both for the use in the current form, but also for the adolescent use where there is currently none approved. So as I said, till the end of the year, we believe anywhere around INR 3-plus crores we hope to manufacture and supply. And that is our full capacity. So we are going to be making a full capacity.

Okay. Sir, my next question is about the -- even the expectations about, let's say, Verafin what we have been so excited about. So obviously, the number of COVID cases has come down. So is it better to think that, okay, the opportunities really drying out here? And that is one. And a clarification about this minority interest is higher since last couple of quarters or last 2 quarters. Is it because that there is a kind of COVID-related benefit that you've seen in the consumer business and hence, the minority interest is looking a bit elevated?

So on the first question, I mean, if we all understand what's happening to -- with COVID-19 and the impact it has everywhere and the way it's moving, you know that the infections and the peaks come in waves and in cycles. So we have obviously gone through a very strong second cycle or second wave of COVID. But we know that -- with what we are seeing in Europe in the rest of the world, we know that there is an imminent way of the third wave that will be there. So the opportunistic products or products that are related to COVID will obviously make more sense when you see those kind of problems around. For Verafin specifically, we are also looking to export it in other countries. And we are also looking to build an outside India business beyond what is India. But currently, what you say is right, in India, there are much lower cases and prevalent. So currently, the need for COVID drugs is lower. But both for Verafin, remdesivir, we are seeing -- we will see potentially a good export market that we want to build for. For remdesivir, we have significantly good export business and India business still, and we will do the same for Verafin also. Related to your second question, maybe Vishal or Nitin can take it up.

Yes. So Surya, actually, the noncontrolling interest is mainly for Zydus Wellness. And as you know, Zydus Wellness is a seasonal business. So it's not equally spread across all the 4 quarters. So quarter 4 of the financial year and quarter 1 of the financial year are the main seasons where you will see higher top line as well as profit in that business. And quarter 2 and quarter 3 are relatively lean because the season for 2 or 3 of their brands is not there. So as a result, you will see this kind of trend every year. So quarter 1 of any year and quarter 4 of any year will have higher profits in Zydus Wellness resulting into higher noncontrolling interest also. One exception was the last financial year where because of first wave of COVID, Zydus Wellness did not have good profits. And as a result, the noncontrolling interest was lower. This quarter onward, it is now normalized.

Next question is from the line of Anubhav Aggarwal from Crédit Suisse.

My question is on the ZyCov-D vaccine. Just trying to understand that we see efficacy data difference between the 3-dose and the 2-dose. I think you have declared 3-dose, but you haven't, I think, mentioned for 2-dose. Can you just talk about, Sharvil, how are they 2 different on the efficacy front?

So the -- between -- the difference between the 3-dose -- I mean, the 3-visit and 2-dose, the amount of dose given is the same. It's just that instead of giving between 0, 28 and 56 days, we do only 2x dosing between 0 and 28 days. So we believe that it will bring obviously far more patient compliance and ease of administration. So that's the -- so I think from the amount of vaccine given, it's the same between the 2 arms. And what we have -- once we obviously get through the registration on that, we'll explain more. But we have seen equal and better immunogenicity and antibody response in the 2-visit versus the 3-visit, and that is where we believe that, that could be the potential mode of use for this vaccine as we move forward.

So would you say that -- so effectively, you're saying the efficacy data is -- you've seen better in the 2 dose -- 3 mg versus 2 mg one. So what about the safety data? Has that been comparable as well?

Yes. So safety-wise also, there have been no safety events or any serious safety events with this arm also. And across all the -- from Phase 1 till now, we have not had any safety concerns, and that obviously has been published and shown to the regulators. So on that, we are fine. And as I just said, it has better immunogenicity, so it could potentially have a higher efficacy. But currently, I would say conservatively to assume similar efficacy would be right.

And what kind of population base like you ran the trial on 28,000 patients on 2 mg one? On 3 mg one, what was the population base on which you ran the trial?

So the phase -- the 3 mg trial has been done on the immunogenicity point of view. So it has been done in close to -- I don't have the exact number right now, but close to, I think, 800 to 1,000.

Okay. And for the adolescent, are you going for the 2-dose version even for the adolescent? Or for them, it's a 3-dose -- 2 mg one only?

So again, these are all for the regulators to discuss. We believe with the body of evidence and data we have shown, it potentially will also be a 2-dose regimen -- 2-visit regimen.

Sure. And for the export market, have you already started applying or once you get the emergency authorization here in India, then you will start applying to the export market?

So it's still work-in-progress. For us, the current capacities that we have, we feel we will not have enough capacity to serve India. So to look at export is not something practical right now because obviously, we don't be able to make any supplies. But we are looking at partnerships and to see whether we can partner for future supplies and maybe give technology transfer to other countries for manufacturing of these vaccines. Few of them have approached us. So we are in those discussion phases. But in the near term, this -- we are largely only focused for India right now.

Our next question is from the line of [indiscernible] Parik from Choice Institutional Equities.

Hello. Am I audible?

Yes, you are.

Yes. So my question is on wellness. It's a follow-up question. Sharvil sir, just said that Q1 and Q4 is like the seasonally strong quarter. So would it be right to assume that the next 2 quarters, the growth rate will taper down to what it has reported in Q1?

So growth is obviously corresponding to the last quarter of the previous financial year. So it is not an impact of growth. It's the absolute sales. Quarter 4 and quarter 1 are larger versus quarter 2 and quarter 3. But we are not talking about growth tapering down. We're talking about the size of the business being different between the quarters.

Okay. And sir, can you just throw some color on the U.S. business, like we have -- we are seeing Delta variant over there and price erosion. So what will the probable impact to be on the U.S. sales out of these situation?

So currently, the impact mostly is because of the price of more competition and less disruption in supply, which -- and so I think the growth possibility is only when you are -- with the possibilities of new launches that we get to do. And U.S. is a cyclical business. So it goes through these cycles of consolidation and again, then disruption. So we believe that if you have the breadth of portfolio, which is large enough and if you have good operational efficiencies and good inventory positions, one will see an opportunity that one will get to build on from the existing portfolio. And the rest is obviously to file new portfolio, which we have been doing and launching new products and slowly building 2 franchises, the transdermal side and the injectable side, which can be very large and sizable for the organization.

Okay. And if I may just ask one more question. I just wanted to know, like, how much percentage of COVID drugs do we export?

Currently, it's only remdesivir, in a way, because the government had blocked exports for a very long time. So the currently it's only remdesivir and no other drugs which are more COVID-related

Okay. So that would be like less than 5% of the COVID portfolio that we would be exporting?

The export of remdesivir. I don't have the exact number, but it's not very large for the last quarter.

The next question is from the line of Prakash Agarwal from Axis Capital.

Yes. First one is on the U.S. growth trajectory. So much has been talked about kind of approvals expected, launches, JVs and injectables and all. But qualitatively, I mean, on this base that we are clocking around $200 million. Do we see growth going forward in this year and next year? Or do we see that these opportunities that we spoke about, this would be able to cover the base business price erosion? How do we see this for the next 6, 12 months or over the next 12, 18 months?

So for the immediate quarters we are saying we'll do a little bit better. So there will be some minor growth or a single-digit growth that we are aspiring for in the next quarter and beyond. Going forward, in the next financial year, with some new products, some settlements that we have and more of some of the injectable launches that we hope to see very soon and some of the more complex oral new product approvals that we are getting to see in the next quarter, we hope we can build up on that base to minimize the erosion that we may see on one of our mesalamine franchise. So that should offset that. And then more new product launches can build up on the traction on the U.S. business. So I still believe for the next 3 to 4 quarters, we would see a low single-digit growth. And maybe protecting the base would be the right way to look at it, other than some opportunistic things that we get to see, which we don't -- we can't -- we don't know of and which we can't plan for. But going forward, I think the other portfolios coming in, which is injectables and transdermals with the clearance, once we get for Moraiya, we'll get to see some better traction on new product successes.

Yes. I mean, that pulls me to the second question on Moraiya. So if there is any update on desktop inspection, we're hearing that couple of inspections have started in Hyderabad. So any update there? Or what are you hearing? Or what are you getting prepared for?

So one, we have now at least got the clearance from the FDA point of view, understanding that we have finished our process of corrective actions, and they have been submitted and they have been accepted by the FDA, and the FDA will schedule for an audit. Now the audit with -- in terms of physical audit or any other form of audit is still unknown, but we will now -- we are expecting an audit is what we can say.

So would I understand the CAPA plan, you already introduced the CAPA plan as required?

Yes. It's already been executed and discussed and closed. We are -- now we need some sort of inspection to get triggered for getting out of the warning letter.

Perfect. And lastly, on the margin side, there was a mention, sir, on this, we are expecting efficiencies to kick in and margins to improve by 80 bps, 100 bps. That is on the current base of 22%, 23%? Or that was more like a generic statement? So how do we think about margin expansion for this year and next year?

So it's on a current base.

Okay. So which is about 22%, 23%?

Yes. Yes.

And this is over 12 to 18 months?

Yes, 12 months, yes.

Our next question is from the line of Kunal Dhamesha from Emkay Global.

So on the generic injectable business, specifically in U.S., what is our aspiration? What is our current size in terms of number of products? And maybe if you can share value. And from which plant our future pipeline is kind of high?

So our aspiration for the U.S. injectable business is that we want to build at least a $250-plus million business in the next 3 to 4 years. And that's our current estimate. And this includes a lot of important complex products as well as large number of products that we hope to still continue to file. Our critical sites for U.S. injectables business is our site in Vadodara, which is Liva, which has 4 lines and it is approved by the U.S. FDA, at least 2 of the lines are already approved. We have 1 new site, which is a biologic site, where we got prefilled syringe approval. And so that site stands approved. And then we have our Alidac site which manufactures cytotoxic injectables where we sell liposomal doxorubicin from, and no hope to file for other injectables also there. And then we have 1 of our joint venture sites, which does CMO work for us also where we would also see some oncology filing and launch from. So these are largely the plants which are used. They all have currently a very good track record of multiple inspections and have done well with their inspection. So they are all good. In terms of complex injectables, 1 strategy that we do also have is that we also have partnered in products where these products are partnered in from European and some of the Asian countries, and they also have a good track record on the FDA, and we will be also launching many of the injectables through our in-license portfolio.

Sure. And if you can provide the size of the current U.S. injectable portfolio?

I'm not -- it's $35 million, I think.

Yes, it's about $35 million per annum.

Sure. And second question, again, coming back to vaccine. So I believe we had 1 data request from DCGI, and I think we have complied to that. So at this moment, what is pending? Is there another data request from them or we are just waiting for the response?