Good evening, ladies and gentlemen. Welcome to our post-results teleconference for the quarter ending 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 Garg, 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 exchanges. I'm sure you would have received the same. Among our two 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 it, 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 healthcare 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 ending 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 animal health for all the periods have been shown separately as profits from discontinued operations in the profit and loss account. During the quarter, we posted consolidated revenues of ₹40.3 billion, up 15% year-on-year. Consolidated EBITDA improved during the quarter and stood at ₹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 the improvement in EBITDA margins despite the inflationary pressures. Consolidated PAT for the quarter was ₹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 ₹19.4 billion. The U.S. geography comprising of generics and specialty portfolio posted sales of ₹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 ₹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 1st quarter of FY 2022 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 ₹13.57 billion during the Q1 FY 2022, up 64% on a year-on-year basis. The growth was supported by both the COVID 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 nutraceuticals therapeutic areas during the quarter vis-a-vis the corresponding quarter of the previous year. Going forward, with a 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 five out of seven brands that resulted in an overall 10% growth on a year-on-year basis and revenues of INR 5.9 billion. The summer seasons 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 in 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 one-time 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 could 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 healthcare delivery, offering better customer experience, and building responsive backend, 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 healthcare delivery experience to all the stakeholders. On the consumer wellness 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 operation side, we are working on the use of advanced digital and analytical tools that will enhance overall compliance and efficiency through 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 operations 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. This concludes the business review. I would 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, Nayak sir, 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 12-18 in India. Around 1,000 subjects were enrolled in this age group, 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 two-visit vaccine. On the NCE front, recently in the month of July, we are very happy to say that the EMA, the European Medicines Agency, granted orphan drug designation to saroglitazar magnesium for primary biliary cholangitis indication. ODD 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 incidence increases after the age of 50. Across the world, PBC primarily affects an estimated 1 in 1,000 women over the age group of 40. Global market for PBC treatment is expected to grow at a CAGR of 36% from 2018 to 2026, and is expected to reach approximately $11 billion by 2026. Approximately 40% of the patients are either non or partial responders to the current modes of treatment, resulting in a highly 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 DCGI to initiate phase I clinical trial for a novel multi-dose anti-malarial molecule, ZY-19489. 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 NCE and specialty initiatives. During the quarter, we received a response in the US 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 2023. Cumulative number of such in-licensed 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 180-day exclusivity upon launch. Thank you. We'll now move over to the Q&A session. Over to the coordinator. Thank you very much. Ladies and gentlemen, we will now begin the question-and-answer session. Anyone who wishes to ask a question may press star one on their touch-tone telephone. If you wish to remove yourself from the question queue, you may press star two. Participants are requested to use handsets while asking a question. Also, participants connected on webcast, please click on the below link to follow the instructions to ask questions via audio. Anyone who wishes to ask a question may please press star 1. First question is from the line of Tushar Manudhane from Motilal Oswal. Please go ahead. Yeah, thanks for the opportunity. Just on these in-licensing deals you alluded for revenue contribution from FY 2023 onwards. Any further color on this in terms of further quantifying of how much this revenue contribution can be? 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. The in-licensing opportunities are generally products which are very niche or products which have low competition. They all have a significantly good commercial potential than any of the normal molecules. They are obviously the high-value products. Exact value, it's not possible to give in terms of the next two to three 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 two of these products is also where we have got 180-day exclusivity potentially. They are all meaningfully large value products. These will be manufactured at our Alidac or 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 licensing. Just lastly, how much would be the share of COVID-related revenue for the quarter, I mean, in the human health business? I couldn't understand the question. Sir, the share of COVID-related revenue in the human health business for the quarter gone by. Large part of the revenue, majority of the revenue was obviously COVID-related, was remdesivir. Minus remdesivir, our growth was 35-plus% for the branded formulation. Got it. Thank you. That's it from my side. Thank you. Our next question is from the line of Kunal Dhamesha from Emkay Global. Please go ahead. Yeah, thank you for taking my question. First on the U.S. business, we said the weakness is attributed, one of the factors is one-time buy. I think that should be positive impact, right? Was that in this quarter or the last quarter we had some one-time buy which did not recur in the first quarter? One-time buys, we have been seeing it for many years in the last couple of years because of disruption in supply chain. In the last six months, we've seen these one-time buys have dried up because there is very little issue with supply chain in the U.S. We haven't seen any meaningful one-time buys in the last six months. Sure. Secondly, I think we have launched four products in U.S. vis-a-vis our target was somewhere around launching 30 to 35 products. Are we still on track to achieve that? In the U.S., we still do expect to get close to 50+ approvals, some being tentative, and we will still achieve 30+ launches. Sure. Secondly, on the vaccine opportunity, now that around 55% of the adult population has been vaccinated with at least one dose, and every last month reduces the remaining market by at least 20%, 35%. How do you see this opportunity now and in the adult market, as well as in the adolescent? On the adolescent front, have we also submitted for emergency use authorization for our vaccine? 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. As soon as we know anything more, we will apprise everyone about it. With respect to the opportunity for COVID, our current capacity is that if we fully manufacture our sales at the max between 10 to 15 million doses monthly, which is not very large in terms of the overall need of the vaccination. Even at the adult population, I think for us, I don't think the difficulty will be in being able to secure the business for the manufacturing capacities that we have. We still feel we should be able to supply whatever we can make because we are talking about 1 crore doses or 1.5 crore doses, which are not very large in the overall requirement point of view. Sure. If I may squeeze in the last one. In terms of vaccine manufacturing, have we started stockpiling? I believe our plant was supposed to be commercialized somewhere in July. Have we started stockpiling in the anticipation of approval, or we'll start manufacturing at commercial scale after approval? In our smaller facility, we have started manufacturing commercially for stockpiling. In our new facility, the activities are starting as of this week. Sure. Thank you. Thank you. Our next question is from the line of Surya Patra from PhillipCapital. Please go ahead. Thanks for this opportunity. My first question from the U.S. Any specific reason why we are seeing a kind of sequential- Sorry, your voice is not quite clear. Hello. Is it audible? Yes, a slight disturbance, but yeah, it's audible now. Okay. 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 we know that the previous quarter was not a great quarter in any manner about the flu sales contribution. Hence there was no reason for a kind of sequential correction, although there was a kind of issue of a pricing pressure. Given that, what is the kind of outlook that you are having for the full year in U.S.? In the U.S., two things which we spoke about in our conference call. One is there is a lot more competition that we get to see on established products and new products with more approvals that have come through, both from existing and new players. That is something that has definitely happened to the market, where you're seeing far more competition and bids. Second is that there have been least supply disruptions during the last one year. That also means that what we used to get with the opportunities of one-time sales by being able to supply products which are in shortage, that issue has come down for the oral drugs. That's the second part by which we see some gap. Thirdly, we have said that 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. Those are some of the things that have happened, which has led to this. For us, for annual point of view, we are still looking at a low single-digit growth for this year. If some of the critical new products succeed, we can see some better traction on that. That is our current estimate. In terms of the next two to three years, we believe that both transdermals and our specialty injectables and some of the complex oral strip 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 initiatives. 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 the COVISHIELD plus COVAXIN, the approval of the J&J's single dose, and your recent commentary to the earlier question that your expectation of 1 to 1.5 crore kind of per month target, that anyway can be achievable anyway. That means, are you kind of moderating your expectations here? Hello? Hello. Hello. Are you done with your question? Hello. Yes, Surya, sorry, your voice is not very clear. Yeah. My second question was on the vaccine opportunity, sir. I was saying that given the recent developments about the allowing or approval of the COVISHIELD plus COVAXIN kind of mix in India and the single dose of J&J. Sir, right now you have mentioned about your expectation of a INR 1-1.5 crore per month kind of volume. Whether that is a kind of moderation from your earlier expectation that you were thinking about achieving INR 3 to 5 crore kind of level by December or so. Anything on that front? I think your question, I understand, but I think you're mixing two things. When I say INR 1 crore-1.5 crore, that is monthly, and what we had said INR 3.5 crore was till December. We haven't moderated our stands yet. We believe that currently, 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. 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's nobody who's achieving more than INR 1 crore-2 crore, and any of the approved vaccines have not reached commercial availability at all in India. I think in India, we still require a lot of vaccines. For us, we believe that with whatever understanding we have, we have 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. As I said, till end of the year, we believe anywhere around 3+ crores we hope to manufacture and supply. That is at full capacity. We are going to be making full capacity. Okay. Sir, my next question is about even the expectations about, let's say, Virafin, what we have been so excited about. Obviously, the number of COVID cases has come down. Is it better to think that, okay, the opportunity is really drying out here, and that is one. A clarification about this minority interest since higher since last couple of quarter or last two quarters. Is it because that there is a kind of COVID-related benefit that is seen in the consumer business, and hence the minority interest is looking a bit elevated? On the first question, if we all understand what's happening 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. We have obviously gone through a very strong second cycle or second wave of COVID. We know that with what we are seeing in Europe, in the rest of the world, we know that there is an imminent wave of the third wave that will be there. The opportunistic products or products that are related to COVID will obviously make more sense when you see those kind of problems around. For Virafin specifically, we are also looking to export it in other countries. We are also looking to build an outside India business beyond what is India. Currently, what you say is right. In India, there are much lower cases and prevalence. Currently, the need for COVID drugs is lower. Both for Virafin, Remdesivir, we will see a potentially a good export market that we want to build for. For Remdesivir, we have significantly good export business and India business still. We will do the same for Virafin also. Related to your second question, maybe Vishal or Nitin can take it up. Yeah. Surya, actually, the non-controlling interest is mainly for Zydus Wellness. As you know, Zydus Wellness is a seasonal business. It's not equally spread across all the four quarters. Quarter four of the financial year and quarter one of the financial year are the main seasons where you will see higher top line as well as profits in that business. Quarter two and quarter three are relatively lean because the season for two or three of their brands is not there. As a result, you will see this kind of trend every year. Quarter one of any year and quarter four of any year will have higher profits in Zydus Wellness, resulting into higher non-controlling interest also. One exception was last financial year, where because of first wave of COVID, Zydus Wellness did not have good profits. As a result, their non-controlling interest was lower. This quarter onwards it has now normalized. Sure. Okay. Thank you, Vishal. Good luck. Thank you. Next question is from the line of Anubhav Aggarwal from Credit Suisse. Please go ahead. Just trying to understand that PBC 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 about 2 dose. Can you just talk about, Sharvil Bhai, how are the two different from the efficacy side? 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 2 times dosing between 0 and 28 days. We believe that will bring obviously far more patient compliance and ease of administration. I think from the amount of vaccine given is the same between the 2 arms. Once we obviously get through the registration, all that, we'll explain more. We have seen equal and better immunogenicity and antibody response in the 2 visit versus the 3 visit. That is where we believe that that could be the potential mode of use for this vaccine as we move forward. Would you say that, effectively you're saying the efficacy data you've seen better in the 2 dose was 3 mg versus 2 mg 1? What about the safety data? Has that been comparable as well? Yes. Safety-wise also, there have been no safety events or any serious safety events with this arm also. Across from phase I till now, we have not had any safety concerns and that obviously has been published and shown to the regulators. On that we are fine and I just said it has better immunogenicity, so it could potentially have a higher efficacy. Currently, I would say conservatively to assume similar efficacy would be right. 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? The 3 mg trial has been done on the immunogenicity point of view. It has been done in close to, I don't have the exact number right now, but around close to I think 800 to 1,000. Okay. For the adolescent, are you going for the 2-dose version even for the adolescent or for them it's a 2 mg one only? 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. Okay. Yeah. Sure. For the export market, have you already started applying or once you get the emergency use authorization here in India then you will start applying to the export market? 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. To look at export is not something practical right now. Because obviously we won't be able to make any supplies, but we are looking at partnerships and to see whether we can partner for future supplies. Maybe give technology transfer to other countries for manufacturing of these vaccines. Few of them have approached us. We are in those discussion phases. In the near term, we are largely only focused for India right now. Thank you, Sharvil. I join by the team. Thank you. Thank you. Our next question is from the line of Forum Parekh from Choice Institutional Equities. Please go ahead. Hello, am I audible? Yes. Yes, you are. Yeah. My question is on Wellness. It's a follow-up question. The source had just said that Q1 and Q4 is like the seasonally strong quarter. Would it be right to assume that in next two quarters the growth rate will taper down to what it is reported in Q1? Growth is obviously corresponding to the last quarter of the previous financial year. It is not an impact of growth, it's the absolute sale. The quarter four and quarter one are larger versus quarter two and quarter three. We are not talking about growth tapering down. We're talking about the size of the business being different between the quarters. Okay. Sir, if you can just throw some color on the U.S. business, like we are seeing Delta variant over there and price erosion. What would the probable impact be on the U.S. sales out of these situations? Currently the impact mostly is because of the price, more competition and less disruption in supply. I think the growth possibility is only when you are with the possibilities of new launches that we get to do. U.S. is a cyclical business, so it goes through these cycles of consolidation and again then disruption. 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. The rest is obviously to file a new portfolio, which we have been doing and launching new products. Slowly building two franchises, the transdermal side and the injectable side, which can be very large and sizable for the organization. Okay. Sir, if I may just ask one more question. I just wanted to know, 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. Currently it's only remdesivir and no other drugs which are more COVID related. Okay, so that would be less than 5% of the COVID portfolio that you would be exporting? The export of remdesivir, I don't have the exact number, but it's not very large for the last quarter. Okay, no problem. Thank you. Thank you. The next question is from the line of Prakash Agarwal from Axis Capital. Please go ahead. Yeah. Hi. Thanks for the opportunity, and good evening. First one is on the U.S. growth trajectory. Much has been talked about, kind of approvals, expected launches, JVs and for injectables and all. Qualitatively, 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 six to 12 months or over the next 12-18 months? 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 upon that base to minimize the erosion that we may see on one of our mesalazine franchise. That should offset that. More new product launches can build upon the traction on the U.S. business. I still believe for the next three to four quarters, we would see a low single-digit growth. 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 know of and which we can't plan for. Going forward, I think the other portfolios coming in, which is the injectables and transdermals with the clearance, once we get from Moraiya, we'll get to see some better traction on new product successes. Yeah. That pulls me to the second question on Moraiya. If there is any update on desktop inspection? We're hearing that couple of inspections have started in Hyderabad. Any update there or what are you hearing or what are you getting prepared for? 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. The audit in terms of physical audit or any other form of audit is still unknown. We are expecting an audit, is what we can say. What I understand, the CAPA plan, you already executed the CAPA plan as required. Yeah, it's already been executed and discussed and closed. Now we need some sort of inspection to get triggered for getting out of the warning letter. Perfect. Lastly, on the margin side, there was a mention by Nayak sir on this, we are expecting efficiencies to kick in and margins to improve by 80, 100 base. That is on the current base of 22% to 23% or that was more like a generic statement. How do we think about margin expansion for this year and next year? It's on a current base. Okay. Which is about 22%, 23%. Yes. This is over 12-18 months? Yeah, 12 months. Okay, perfect. Great. Thank you. I'll join back the queue. Thank you. Our next question is from the line of Kunal Dhamesha from Emkay Global. Please go ahead. Thank you for giving the opportunity again. On the generic injectable business, specifically in U.S., what is our aspiration? What is our current size in terms of number of products? Maybe if you can share value and from which plant our future pipeline is kind of filed. Our aspiration for the U.S. injectable business is that we want to build at least a $250-plus million business in the next three to four years, and that's our current estimate. 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 two of the lines are already approved. We have 1 new site, which is a biologics site, where we got a prefilled syringe approval. That site stands approved. Then we have our Alidac site, which manufactures cytotoxic injectables where we sell liposomal doxorubicin from, and hope to file for other injectables also there. We have one of our joint venture sites which does CMO work for us also, where we would also see some oncology filing and launch from. 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 inspections, so they are all good. In terms of complex injectables, one 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. 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. If you can provide the size of the current U.S. injectable portfolio. It's INR 35 million, I think. Yeah. It's around INR 35 million for 9M. Sure. Thank you. Second question, again, coming back to vaccines. I believe we had one data request from DCGI, and I think we have complied to that. At this moment, what is pending? Is there another data request from them or we are just waiting for the response? We have one data point that we had to provide last week, but it is being done at a government institute lab, but that has got delayed, so that's getting submitted tomorrow or day after. After that, for at least we believe currently for the approval phase, we would have completed most of our data requests. Sure. One last on the vaccine facility that we have kind of created. What other maybe dosage form or other kind of vaccines or other formulations we can produce in that facility? There are vaccines as two plants. One is a drug substance plant and one is a drug product plant. The drug product plants are existing facilities which make other vaccines and other products also. That is fungible. With respect to the drug substance plant for the DNA vaccine, it's a recombinant vaccine plant, so it can take up some other recombinant products. Currently, for the foreseeable near future, obviously we don't have any other capacities to do anything with this plant. This will be currently dedicated only for the DNA vaccine. Potentially, we are also looking at developing more products, more vaccine platform using this technology. That will be the ongoing work that will continue for this. It is a recombinant plant, so in a way, after some modification, it can be repurposed for some recombinant biologics. Currently, this capacity is going to be fully resourced and dedicated for only vaccine production. Sure. Thank you. Thank you. Next question is from the line of Nimish Mehta from ResearchDelta Advisors. Please go ahead. Yeah, thanks for the opportunity. A lot of my questions have been answered. Just 1 thing on the U.S. side I'd like to know. Are we likely to launch other mesalamine franchise, especially products like Zelnorm in the near future? Some outlook on there would be helpful. Could you repeat the product name? I couldn't hear it well. Zelnorm or any other mesalamine product. We do have a portfolio of at least three more mesalamines that we want to launch, and we would be launching some of them very soon. Meaning in this year itself? Yes. This financial year. Okay, wonderful. Second, just a quick update on the domestic business. How many products are we likely to launch this year in the domestic market? How many of them would be first to market launch? Currently we have a portfolio of about 35 molecules that we are working, which we want to launch, which will either have limited competition or be first to market. In the recent times, we have launched a good amount of franchise in the diabetes space, including vildagliptin, teneligliptin, and future we will be launching some of the other gliptins. That's one. We have launched Nitrogestron, which is again, 1 of the very few limited competition products. Large part of our now future portfolio is driven towards launching low competition or sort of first generic. When we launched our biosimilar Kadcyla, again, it's the only generic in India and in the world. We'll see a healthy pipeline of products that would be first in India, either first generic or potentially first like Lipaglyn. We also have desidustat that we hope to file by end of this year. We would see a large part of portfolio being complex and first kind of launches in India. Beyond that, obviously life cycle management and product life cycle extension happens through doing formulation research that we also continue to do for our products. COVID is a different year. We have launched quite a few COVID products, but on average, we are looking to launch anywhere between 30 to 45 new launches in India. Yeah. A lot of them would be first time in the market, right? 30 to 45 in a year will not all be first time, but if you take a three to four year view, then at least 30 to 35 important critical launches which have limited competition are our day 1 launches. Okay, understood. Thank you very much. Thank you. Our next question is from the line of Sameer Baisiwala from Morgan Stanley. Please go ahead. Thank you and good evening, everyone. Sharvil, this is about the ZyCoV-D vaccine. Question number 1, what are your thoughts on the efficacy study for adolescents? Efficacy is never done in cohorts like that. When you do a large phase III, you do a general efficacy, and then you do a immunogenicity which is divided in different cohorts. Older age group, comorbidities, and then the younger age group. We don't do separate efficacy right now. That will get created once you have a larger set of data. We can talk about overall efficacy, which is a good representation of the overall efficacy. What we do is immunogenicity for all these cohorts to make sure that the antibody response and the IgG as well as the neutralizing antibody response as well as the T cell response or the interferon gamma challenge are all similar, or they're giving different trends. We have seen a very good trend for obviously older age group. In children, we have seen a higher trend on higher antibody formation, potentially it could mean that they have a far better, higher protection. That's how the host all the studies are planned. Okay, great. When you get the approval, you get it for both adolescents and adults? That is what we will be hoping for. Once we get the regulator's nod, we can talk more about it. We have filed for all of this data. Okay. Any timelines when you expect approval and then get into the market? Again, it's very difficult to predict that. As I said, our last set of information, we believe we will submit in the next one to two days. By and large, it's a rolling review that happens. All the other information has already been reviewed. If everything is okay and we also don't see any issue in the last data, and if the data is fine, we can potentially see an approval in the next one to two weeks maximum. Okay. This is pretty close. What's the market access work being done? If you can just share with us, would you be routing it through all private channels, some tie-ups that you have done? Because their volumes are not that large, would you be going all India or just a Western market? Currently, there are three opportunities. One is government sourcing, which potentially could be the largest sourcing that happens, right? The government did commit that they may be potentially buying from any of the vaccines 75% and leaving 25% for the retail. The second is we have also done a lot of activity and created a lot of capability on the digital side to build for the whole supply chain and dose administration and the other things that are required in terms of patient support and other required things. That whole activity is in place, linking it with the app to make sure that the right dosing and everything happens. We have gone beyond it in terms of providing far more critical information. All of that is done. We do have requests from institutions and large institutions and mid-size institutions for direct buying, which we have, in principle, agreed to do so. As soon as we get an approval, as soon as our pricing gets cleared, and as soon as the government commits to their quantities, accordingly, we will obviously then supply to the rest of the market as well. Currently demand, obviously what we produce, we have expectations from customers for more than that, so we will see how we'll be able to commit to the different supplies. Okay. One final one on this, Sharvil. I don't know how comfortable you are talking. Can you talk a bit about the pricing for this government versus private and your margins expectation on this? It's very difficult because we haven't had. Any ballpark. Currently we have a reference price of approval for the government purchases. Obviously, every vaccine is different and the technology is different as well as the investments are different. That is a place where we still need to discuss with the authorities. Obviously, we already know the floor price which exists, which is upwards of INR 200 and plus, which we know of. Then there is a private market. We believe in the private market. We haven't decided yet on the pricing because again, it's a question of volume. How much volume we can give to private market versus what we give to the government will define the pricing also. I think there are a lot of moving parts. I believe it's not too far away. Maybe in the next one to two weeks, we should be able to achieve that also post our approval. As soon as we do that, we can give you an update on it. Okay, excellent. Thank you so much. Just final before I go is on Moraiya. Your guess, is it going to be fiscal 2022 when re-inspection happens, or you think it can go beyond it, keeping in mind the vaccination and the current COVID situation doesn't get any worse? I am still hopeful for fiscal 2022 inspection and clearance. Okay. Thank you so much. We just have to wait for an inspection now. Okay. Got it. Thank you. Our next question is from the line of Harith Ahamed from Spark Capital. Please go ahead. Hi. Good evening. Thanks for the opportunity. My first question is on Asacol HD. You had commented about a slower uptake in the last quarter, in the fourth quarter. Have things normalized on this front? Anything that you're hearing on potential competition in this product? There's a patent expiry that is quite imminent. Two things. Versus last year, we have seen, obviously, the volumes for the brand prescriptions come down. If you say quarter on quarter, then they have stabilized. They're stable quarter on quarter. Over the last year, their prescriptions have come down, as it has done for many products post-COVID. On respect to competition, we currently believe and we know of one company which has filed for the product. I don't think there are any products that have approved yet. Post the patent expiry is only when we'll probably get to know, or a few weeks before that we'll get to know. We made an assumption that we'll get to see one to two competitors in the market. That's our best estimate as of now. Got it. On the transdermal front, how many filings have been made till date? How many of those are from Moraiya, and then how many from the other facility? We have, I think, two products from non-Moraiya facilities, and all the remaining rest are from Moraiya and one from our U.S. facility. Moraiya is largely driving the contraceptive side of the transdermals that we have filed for. Okay. Last one on COVID vaccine. On the two-dose vaccine, will the immunogenicity and safety data that you have already generated, will that suffice for approval? Will there be a requirement for a full-fledged phase III efficacy trial? It's the same amount of dose that we're giving, so we strongly believe that this will suffice for the approval. All right. That's all from my side. Thank you very much. Thank you. The next question is from the line of Ranvir Singh from Sunidhi Securities. Please go ahead. Yeah, thanks for taking my question. Sir, on ZyCoV-D side, just to understand, are we working on any other delivery system for non-invasive, like nasal or something? Needle-free- Hello? dose delivery? Sorry, Mr. Patel, we request you to please repeat. I said, for our current vaccine, it's already an intradermal application, and it's a needle-free application of the dosing. It is already one of the, I would say, future-ended technologies, which are almost non-invasive and which leads to very little side effects. Okay. Just for my understanding, visits and doses are a different nomenclature or this is the same? Sorry? Like we talk about two visits, and sometimes we talk about two doses. These two are different things or this is the same we are talking about? No, sir. Before, we used to give the vaccine over a period of three visits or 3 doses in the way. 0, 28 and 56. Now it'll be over two visits, 0 and 28 days. Okay. It is same like having a 2 dosage at 2 visits. This is the same. It is not like 1 visit may have more doses. No, the dosage earlier was two milligrams over three times, and now it is three milligrams over two times. Okay. On U.S. generic side, the most of competition is major mesalamine products? We see across products that competition has impacted badly? No, it's across products. Like atorvastatin also, we saw competition. I think that would have also impacted Q1 results, right? As of the last four, five months, the competition has been across portfolio for all of the generic companies. It is more wider, it is not specific to a few products. Okay. Last one, the related one. Like 35 products launches we are talking about and single-digit growth. Competition or the price erosion is likely to be deeper even going forward also. You see that now things are getting stabilized? We are seeing at least now a high single-digit erosion. For obviously products which are exclusive, there will be much more erosion. Generally, you're seeing a high single-digit erosion to the U.S. business. That's what we are predicting, at least for the next couple of quarters. Okay. You have spoke about 30-35 product launches in India also in this year? Overall, yes. Okay. That clarifies. Thanks a lot and all the best. Thank you. Our next question is from the line of Kedar from Nirmal Bang Institutional Equities. Please go ahead. Kedar, please go ahead with the question. Hello. Am I audible? Yes. Please go ahead. Yeah. Can you share your biosimilar revenues for the quarter and how much of that was from India? If you could share some color on the biosimilar revenue that should shape up in the emerging markets over the next three years. On the biosimilars front, currently most of our revenue is driven out of India only. In the next calendar year, we will see more launches in the emerging markets and which will add to the overall revenue on the biosimilar side. On the biosimilar in India, I'm sure Vishal can give you the exact number, but I think we are about INR 350 crores right now on an annualized basis. We get to see it to hit INR 500 crores soon. That's where we are on the India biosimilars business. Globally, as I've maybe said earlier also, that we have now nominated 2 biosimilar programs for global development, which will see commercialization post 2025. That's the current plan for biosimilars. Okay. Just to follow up on that, which are the key countries that you will be focusing on in the emerging market? Do you have any plans to out-license or market them on your own? Currently our biosimilar emerging market strategy is mostly licensing. If you look at which will be the focus markets which will also add good revenue to us, it will be the Latin American countries, driven by Mexico and then Colombia, Venezuela and others. In Asia, we are looking at Philippines, Thailand, and Indonesia being the critical markets, and then obviously Sri Lanka and other smaller markets, Myanmar. In Middle East, we want to build towards the Saudi Arabia side of the market. We have also now approvals in Russia. Russia will become a critical market to sell for Russia and the CIS countries nearby. This will be the current plan for the EM markets. What is good for us is that we already have approvals in Russia. We have approvals coming now in Asia and potentially soon approvals in Latin America also. This would help us build at least 3 to 4 biosimilars in all of these markets. Thank you for answering my question. Just a last question that, in case you see a delay in Moraiya resolution, would we potentially see a dip in U.S. revenues? Moraiya has important products which are transdermals, which we need approvals for. They are important in terms of our future revenue. Most of the oral drugs are filed out of other parts. Injectables are also filed out of other sites. They will definitely have an impact. Over a period of time, it will not be meaningful. Okay. Thank you for taking my question. Thank you. The next question is from the line of Anubhav Aggarwal from Credit Suisse. Please go ahead. Yeah. Thank you. Sharvil, one just out of curiosity, this 2mg and 3mg doses. When these were so close, I'm a little surprised that you started with such a large trial on 28,000 patients with 2mg dose, because you very well knew that your vaccine is going to be 3-dose vaccine. What was the hindrance for starting that trial with 3mg dose at that time? Again, this is science that we have been doing. We are doing DNA vaccine for the first time. Obviously we would have not always known how everything moves and as we move forward, things we get to know because the immunogenicity and other data comes out much later and same does animal data and other things. In this development cycle, things kept on happening parallelly and not in sequence, right? That is one part of the issue. The second is, we were also looking at it saying that, if we have a longer time in terms of gap, do we see a higher antibody response? That could potentially also have been. The 3 dose made sense from doing that. What we are now getting to see is that 2 dose is also behaving similar or better. Maybe that hypothesis was not fully there. It's an intradermal delivery, so we had to make sure that we have an application possible that can be done in 2 doses. I mean, 2 times versus 3 visits. That also means because we have to only inject 100 microliters in a way. It's a non-invasive insertion, but we had to do it. All of those were questions that still needed to be answered. That is what happened, and that's how the whole development journey went through. Now we believe that because the safety is similar and obviously the immunogenicity is similar, it will end up being only 2 visits, but it will still be taken on both arms, as it was done in the 2 milligram. Right. Okay. The second question was on the U.S. market, just trying to understand the erosion better in this quarter. Was it that because of the COVID, buyers were having a larger amount of inventory to stock with for the last year, and now they've started reverting back to the normal inventory, and that's why there was a pressure among suppliers because the volume went down from the buyers in terms of purchase. Was it like that the reason that the price erosion increased for everybody in this quarter? Anubhav, I think no, the buying came down, and you can attribute some part to higher inventory. That was mostly to do with last quarter, not this quarter. The gone quarter by. It is more now all around higher competition. We are seeing far more new players with new approvals who seem to be very aggressive in pricing, which we believe in. As for us, it is not practically possible and responsible to be going at such low pricing. That's what's happening to the current market. We are seeing far more bids and far more challenges to pricing, which we believe some of it seems irrational, but I think over a period of time, maybe some of this will stabilize. That's the current scenario. Okay, thanks. That's helpful. Just one more clarity on this U.S. one. When you guide to low single-digit growth in the U.S. business, you're expecting competition in the Asacol this year itself, and despite that competition, you're guiding for 2% to 3% growth? We are assuming at least one generic will be on the market. That is what our current assumption is on the immediate basis. Post-patent expiry. Okay, sure. Thanks, Sharvil. Thank you. Ladies and gentlemen, due to time constraints, that would be our last question for today. I now hand the conference over to Mr. Ganesh Nayak for closing comments. Thank you, and over to you, sir. Thank you very much, and look forward to interacting with you again in the month of October when we declare our Quarter Two results for FY 2022. Thank you, and have a nice evening. Thank you very much. Ladies and gentlemen, on behalf of Cadila Healthcare Limited, that concludes this conference. Thank you all for joining us and you may now disconnect your lines.