Good morning, everyone. I'm Aishwarya Sitharam. I have recently joined the investor relations function for Biocon Limited, and I would like to welcome each one of you to Biocon's earnings call for Q2 FY22. I would like to indicate that all participants will be in the listen only mode, and there will be an opportunity for you to ask questions after the opening remarks conclude. Should you need to raise questions, please select Raise Hand option under the Reactions tab of your Zoom application. We will call out your name and unmute your line to ask the question. While asking, please begin with your name and your organization. Please note that we will not be monitoring questions on the chat box. You can raise any technical concerns that you may be facing for our support team to help. This conference is being recorded. To discuss the company's business performance and outlook, we have today with us the Biocon leadership team, comprising of Dr. Kiran Mazumdar-Shaw, our Executive Chairperson, and other senior management colleagues. I'd like to take this opportunity to also remind everyone about Safe Harbor. Today's discussion may be forward-looking in nature and based on management's current beliefs and expectations. It must be viewed in concurrence with the risks that our business faces that could cause our future results, performance or achievements to differ significantly from what is expressed or implied by such forward-looking statements. After the call, if you need any further information or if you need any clarifications, please get in touch with me or Nikhan. I'd like to turn the call over to Dr. Kiran Mazumdar-Shaw. Over to you, ma'am. Thanks, Aishwarya. Good morning, everyone. Welcome to Biocon's earnings call for the second quarter and first half of FY 2022. I would like to start this earnings call on a note of cautious optimism when it comes to the pandemic. The timely mass vaccination drive that we saw across the nation in the past few months has certainly helped to abate the spread of the virus considerably. Having crossed the mega milestone of 1 billion vaccine doses yesterday, which I think was a huge milestone for the nation, we hope that we will soon see the worst of the COVID-19 pandemic behind us. However, I'm sure all of you will agree that we just cannot afford to allow complacency to reverse this situation, and we must all continue to exercise caution and stay safe. Biocon, as you know, has been at the forefront in the fight against COVID-19 through our portfolio of remdesivir, rituximab, and Itolizumab. We have added to this effort through our collaboration with Adagio Therapeutics for their novel antibody therapy, ADG-20, and thereafter with Serum Institute Life Sciences for vaccines. This certainly takes us several steps further in strengthening our portfolio of therapies for the treatment and prevention of COVID-19. These collaborations, we believe, will enable us to expand our focus into the communicable disease space, thereby providing a comprehensive portfolio of affordable therapies for global healthcare. Let me begin with a board update. As part of our board updates, pursuant to the vacancy created by the retirement of Mr. John Shaw, Dr. Eric Mazumdar has been appointed as Non-Executive Director to the board of Biocon Limited with effect from November first, 2021. Eric Mazumdar is an assistant professor of computing and mathematical sciences and economics at the California Institute of Technology. He has worked extensively in research at the intersection of engineering, machine learning, and economics at reputed institutes such as the University of California, Berkeley, the MIT Computer Science and Artificial Intelligence Laboratory, and the MIT Koch Institute for Integrative Cancer Research. Eric Mazumdar holds a PhD in Electrical Engineering and Computer Sciences from the University of California, Berkeley, and a Bachelor of Science in Electrical Engineering and Computer Science from the Massachusetts Institute of Technology. We believe that his induction will give a strong impetus to our digital initiative, especially in the area of artificial intelligence and digital transformations. Coming to business highlights. Let me now take you through the key highlights of this quarter. Before I talk about everolimus, we did see a launch of labetalol hydrochloride tablets and esomeprazole magnesium delayed release capsules earlier this quarter. Of course, the most significant launch was that of everolimus tablets, a generic version of Afinitor in the U.S. as a day 1 launch on the 1st of October. We expect that this will significantly drive the growth of our generics portfolio in the 2nd half of this fiscal. Another bit of important news was the approval that we received as for the world's 1st interchangeable biosimilar from the U.S. FDA for our biosimilar glargine Semglee, which has now been included as a preferred glargine brand on the national preferred formulary of Express Scripts. This was indeed a great impetus to the interchangeable label, which is expected to drive significant future growth for our biosimilars business, especially in the insulins segment. We had earlier reported that we had entered into a strategic alliance with Serum Institute Life Sciences to foray into vaccines, by which we get committed access to 100 million doses of vaccines annually for 15 years, in exchange for approximately a 15% stake in Biocon Biologics at a post-money valuation of INR 4.9 billion. We also entered into a partnership with Adagio Therapeutics to manufacture and commercialize a broadly neutralizing novel antibody, ADG20, for the prevention and treatment of COVID-19 for several markets across GCC and Asia, including, of course, India. Let me now move on to the financial highlights for this quarter. Revenues for Q2 FY 2022 were at INR 1,945 crores versus INR 1,765 crores, which represents a year-on-year growth of 10%. Our revenues were mainly driven by research services, which were up 17%, and biosimilars that were up 10%. Revenues in our generics business saw a 12% decline. We recorded a gross R&D spend of INR 165 crores for this quarter, which is very similar to that of last fiscal, which corresponds to 13% of revenue ex-Syngene. Of this, INR 146 crores is expensed in the P&L, while the balance amount has been capitalized. We also recorded a forex gain of INR 20 crores as compared to a loss of INR 18 crores during Q2 FY 2021. Core margin, that is EBITDA margin, net of licensing, forex, Adagio revaluation gains, and R&D, stood at 33% compared to 32% in the same quarter last year on account of an improved performance in both biosimilars and research services. EBITDA for the quarter was INR 551 crores, a growth of 35% year-on-year. The EBITDA margin stood at 28%, as against 23% reported in Q2 FY 2021. Profit before tax, or PBT, for the quarter, excluding an exceptional charge of INR 70 crores, stood at INR 276 crores, up 27% versus INR 218 crores during the same quarter last fiscal. The exceptional charge relates to modification of the optionally convertible debentures of a PE investment in Biocon Biologics and reversal of SEIS claims relating to the prior period, which, as all of you know, has been restricted to INR 5 crores per exporter. This has actually hit both Syngene and Biocon Biologics and Biocon sales profitability. Our net profit for the quarter, before such exceptional charge and associated tax, stood at INR 188 crores versus INR 169 crores in Q2 FY 2021, which represents a growth of 11%. After adjusting for exceptional charge, net profit stands at INR 138 crores. Now, let me turn to the performance of our business segments during the quarter. Let me start with our generics business, which witnessed a subdued performance this quarter as a result of continuing pricing pressure in the U.S. for our formulations portfolio and a slower-than-expected ramp-up of demand for some of our key APIs. Advanced buying by customers in the corresponding period of the previous fiscal, in terms of being apprehensive of COVID-19-related disruptions, is reflected in the year-on-year decrease in our revenues. Operational and supply challenges in the earlier part of Q2 FY 2022 also impacted the performance of the API business. The segment delivered quarterly revenues of INR 530 crores, a decline of 12% over Q2 FY 2021. The quarter's PBT was at INR 50 crores versus INR 70 crores in the same period last fiscal, and PBT margins were at 9% compared to 12% last fiscal. Our statin formulations portfolio in the U.S., comprising rosuvastatin, simvastatin, and atorvastatin, held on to their market share. Despite continued pricing pressure, while tacrolimus capsules maintained similar volumes to Q1 FY2022. Labetalol hydrochloride tablets and esomeprazole magnesium delayed release capsules were launched earlier in the quarter. Following this, we launched everolimus tablets, a generic version of Afinitor, as a first-day launch on October 1, 2021. This is the first day 1 launch for our generics formulation business. Everolimus is a prescription medication that is used to treat certain types of cancers and tumors. In September, the U.S. FDA conducted a remote interactive evaluation for our oral solid dosage manufacturing facility in Bengaluru as part of the pre-approval review for previously filed ANDAs. The final close-out report from the agency is awaited. Our greenfield immunosuppressants API manufacturing facility in Visakhapatnam remains on track to be commissioned in the latter part of FY 2022, with qualification and validation in FY 2023. With remote inspections finally underway, we are hopeful that future inspections will pave the way for our new product launches and expansion into key markets. We will continue to focus on capacity enhancement projects as well as operational efficiencies and expect strong growth from FY 2023 onwards in terms of our generics business. Coming to novels. Equillium, our U.S.-based partner, has announced plans to initiate a phase III pivotal study for the use of Itolizumab in first-line treatment of acute graft versus host disease, following regulatory feedback from the U.S. FDA, and is on track to commence the study in Q4 of calendar year 2021. During the quarter, our Boston-based associate, Bicara Therapeutics, continued to make progress in the dose-finding part of the phase I trial for its lead program, BCA101, as a single agent and in combination with a PD-1 inhibitor. On the basis of the current progress, Bicara anticipates declaring the recommended dose for expansion by the end of calendar year 2021. Coming to biosimilars. Biocon Biologics recorded revenues of INR 743 crore for Q2, a year-on-year growth of 10%. The previous quarter had benefited from a higher contribution from our COVID portfolio, which has come off this quarter. Excluding the COVID portfolio, we have seen sequential growth of 11% of our biosimilars business. EBITDA for the quarter was up 72% year-on-year at INR 303 crore. This includes the revaluation gains made from the equity investment in Adagio at the IPO. Core EBITDA margins excluding R&D, forex licensing income, and Adagio revaluation gains stood at INR 304 crores, which is up 15% year-on-year. Core EBITDA margin was at 42% for the quarter. The improvement in margins have resulted primarily from incremental profits in developed markets. Profit before tax, excluding the exceptional charge, stood at INR 119 crores, up 47% year-on-year. This also excludes the revaluation gain arising from our investment in Adagio. We continue to strengthen our presence in emerging markets with the launch of new products as well as sustaining our existing business. The branded formulation India business continues to witness strong performance on the back of improved secondary sales. In the U.S., Fulphila and Ogivri continue to be resilient despite competition with market shares hovering around 9%. A steady improvement in the market share of our oncology products is expected to support the overall growth of our biosimilars business. The U.S. FDA has approved Semglee as the first interchangeable biosimilar product under the 351 regulatory pathway, which allows substitution of Semglee for the reference product at the pharmacy counter. This has been a marquee milestone for Biocon Biologics and Viatris. Our partner, Viatris, plans to transition the current product to the 351 interchangeable product in the coming months. We have just received breaking news yesterday to say that our biosimilar insulin glargine, Semglee, has been included as a preferred glargine brand on the national preferred formulary of Express Scripts, as many of you know, is one of the largest pharmacy benefit management organizations in the U.S. The formulary covers more than 28 million lives. As a result of this, we expect Semglee to gain commensurate market share in the U.S. from calendar year 2022, making it an important growth driver for Biocon Biologics. The U.S. FDA conducted a pre-approval inspection of our Malaysia facility last month for our biosimilar aspart BLA. We have responded to the agency with a CAPA plan and are confident of addressing the observations made during the inspection. We do not expect the outcome of this inspection to impact our commercialization plans in the U.S. We continue to work closely with the U.S. to expedite the pre-approval site inspection in India for biosimilar bevacizumab. We have, as you can imagine, requested them for a remote inspection like they have done for one of the Biocon Generics facility. However, we have not yet had a positive response from U.S. FDA for such an inspection. Our market share in Europe continues to improve with products like Ogivri crossing the 5% mark in July, and Hulio continuing to see steady improvement. In Q2, our biosimilar bevacizumab, Abevmy, was launched in several EU markets, including Germany, Croatia, Czech Republic, and Slovakia. In Canada and Australia, we continue to see a robust performance of Ogivri. We have also just received regulatory approval for our biosimilar insulin aspart in Canada. We have also made a strategic move into communicable diseases through two key partnerships, one with Serum Institute Life Sciences for vaccines and infectious disease antibodies, and the second with Adagio Therapeutics for a novel COVID-19 antibody therapy. The Serum Institute Life Sciences strategic alliance provides Biocon Biologics an asset-light and accelerated entry into the vaccine segment. Pursuant to the terms of the agreement, Biocon Biologics will generate a committed revenue stream and related margins commencing H2 fiscal year 2023. The near-term focus will be on COVID-19 vaccines since a large part of the global population remains unvaccinated. Only 3% of people in low-income countries have received at least one dose. There is also strong potential from the booster dose of COVID-19 vaccines. Additionally, the partnership will have access to Serum Institute Life Sciences' current development pipeline to address unmet needs in other communicable diseases, like mosquito-borne infections. The platform enables Biocon Biologics to add next-generation vaccines that will drive long-term growth. Biocon Biologics has also entered into a partnership with Adagio Therapeutics for ADG20, a novel antibody therapy for COVID-19. This entails manufacturing and commercialization in several emerging markets, including India. ADG20 is being developed for the prevention and treatment of COVID-19 as a single-dose intramuscular injection. It has the potential to effectively neutralize a broad range of coronavirus, including SARS-CoV-2 and its emerging variants. The company is currently conducting its phase II-III pivotal trials to support an emergency use authorization application by the first quarter of calendar year 2022. To summarize, we clearly see the biosimilars business gaining momentum with the launch of interchangeable glargine in the U.S. and continued launches and market share gains for our portfolio globally. This will be augmented by our strategic foray into vaccines and biologics for infectious diseases. We continue to invest in creating a robust pipeline of products enabling sustainable value accretion for our shareholders. Coming to research services. Which is really the Syngene business. For Q2, revenue from operations was up 17% to INR 610 crore from INR 520 crore last fiscal. Profit before tax, excluding the exceptional charge, increased to INR 113 crore versus INR 94 crore. The second quarter was characterized by strong performance in all divisions, including adding 25 new clients in discovery services, which lies at the heart of our research activities. Syngene also continued to expand relationships with existing clients and long-term partners in the dedicated research centers. Syngene continued to manufacture remdesivir during the quarter, although the volumes are dropping as the impact of vaccination reduces the need for treatments such as this. Strong performance delivered in the first half of the year is expected to also deliver a good performance in the second half. In conclusion, I would like to say that the expansion of our generics portfolio, the grant of interchangeability of our biosimilar insulin glargine and its inclusion in Express Scripts National Formulary, and the collaborations that we have entered into with SILS and Adagio have now created more opportunities than ever to build for a stronger future and fulfill our goal of making large-scale impact on global healthcare through affordable access. With this, I would like to open it up to question and answers. Thank you, ma'am. I'd like to remind everyone, in case you need to ask a question, please select the Raise Hand option under the Reaction tab of your Zoom application. We will call out your name and unmute your line to ask the question. The first question is from Prakash Agarwal from Axis Capital. Hi. Good morning, ma'am, and good morning to team. My first question is on outlook, where you mentioned, obviously. From an outlook perspective, you mentioned, second half is looking better, obviously, and that insulin glargine interchangeability and with the hire with Express Scripts from calendar 2022. My question actually on the other base business, trastuzumab and PEG. How do we see the journey from here for these two products and for the other two products, which is bevacizumab, which is awaiting the approval, what are the timelines there, and insulin aspart? Basically, ex-insulin glargine, because insulin glargine is, I think, pretty much set for its growth path. Prakash, I'll just answer some of those questions, and then I'll sort of leave it to Shreehas to answer the rest. I think you're right. bevacizumab is an approval we are very eagerly awaiting. At the moment, we have really no visibility in terms of when we will have this inspection done. As you know, in recent times, there have been multiple reports of many product approval delays in the U.S., and we happen to be one of them. We do hope that this inspection will happen sooner than later. We have tried to get them to even consider a remote inspection. We will keep you informed as soon as we get any information. I think the rest of the questions I will leave it to Shreehas to basically respond to. Thanks, Kiran. I think to respond, Prakash, to the two products that you talked about, particularly Fulphila and Ogivri in the U.S. I think we've discussed this in the past, that we've seen the pandemic phase that Onpro, particularly in the Fulphila basket, held on to a market share in a sense, artificially, given the convenience factor as people footfalls reduced to hospitals. We're seeing that particular market share come off from a little above 60% to the mid-50s. That part is starting to move towards the syringes space, which is where we are operating. We've not got all of it moving towards Fulphila, but we're starting to see that as a positive development. We've obviously held on to a strong market share, which is just below that double-digit, and we see that progressing well as we get into the next calendar year. For trastuzumab, we've seen to hold the pole position or the second position, I would say, after the other biosimilar on the 150. On the 440, we've seen some competition push past on more aggressive pricing strategies. It hasn't really overall impacted the Ogivri brand strategy that Biocon has come up with, and we've held on to that just under 10% market share even in the recent couple of months. We see this as a steady positioning, which will only improve as we move along to the next fiscal. bevacizumab, I think Kiran has already covered. We remain bullish on that as it completes our portfolio offering in the oncology space, and allows us a more complete portfolio to discuss with payers. Prakash, would you have any follow-up or we can move on? Okay, the next question is from Surya Patra, from PhillipCapital. Okay. Thanks for this opportunity and good morning, everybody. Just before getting into the questions, can I just get the clarity about the other income number, why is that so elevated? The other? Other income. Quantify that, what is the kind of the revaluation gain on that, as you are in the nature of that. Kiran, can I clarify? Yeah. Please. Yeah. Go ahead. Surya, hi. Good morning. Yeah, good morning. In August, we had invested $5 million in Adagio Therapeutics as part of that in the IPO at $17 a share. The share was trading at $42 on 30th September, and the gains on account of that has been recorded as other income. Okay. Can you quantify, sir, what is that number that is there in the? 55 crores. Sorry. Sure. Yeah. Fine. Okay, just extending that Adagio, these things. The progress on the product, the ADG20 and all that. What is the commercial scope there, and what is the competitive advantage of that molecule in neutralizing COVID cases? Compared to other antibodies that is there in various stages of development or in various stages of progress, and what is our aspiration there, anything on that front? Yeah, I think Shreehas, you can take this question. Sure. Surya, I think the ADG20 product that we partnered with Adagio on is a broad neutralizing antibody. It really has shown a very high efficacy in all known variants. In fact, recently Adagio has published an in vitro study where ADG20 has really shown a very high efficacy against all known variants, including the Delta variant, the Lambda variant, the Mu variant. Even as other antiviral therapies are available, where the efficacy are in the region of 50% or thereabouts, I think it is quite obvious that the antibody therapies have an efficacy of over 80% within the gold standard. ADG20 specifically has a very unique positioning where it's a single therapy or monotherapy with one short intramuscular dose, which can be given in an outpatient setting, really improving the convenience of it. The way it has been designed is with an extended shelf life, which is expected to offer protection for close to 1 year or thereabouts. Really then offers a lot of security to a wide section of population, which is at high risk or immunocompromised or were unable to develop immunity despite vaccinations. There are two studies that Adagio has been conducting apart from the 6-month study that they've already published in the phase I, where they are doing a phase II, III study. One is the STAMP study for treatment that I just talked about. The other study is about EVADE, which is a pivotal study to look at prophylaxis, which should then target a very large section of the population, thereby allowing peace of mind as we go along without necessarily getting infected. A kind of a shot which you can protect yourself directly without waiting for an incubation period of weeks, which a typical vaccine would do. We believe the product positioning is very strong and offers several USPs over existing therapies, either in the small molecule space or even in the antibody space, which are either approved under the EUA today or are under development. Just a clarification for the markets. Did we lose Surya or? Yeah. Shreehas Tambe, a bit of clarification on markets we have presented. Well, yeah. Of course, we are going to be present in India and several India-like markets that we've looked at. We are present in countries in the Middle East and in Asia Pacific, where we've chosen select markets to focus on where we believe this therapy can make a very big difference. I think we lost Surya, probably in the process. Yeah. We'll wait for him to join back. The next question is from Damayanti Kerai from HSBC. Hello. Damayanti, you're on mute. Yeah. Hi, good morning. Thanks for the opportunity. My first question is coming back to Ogivri and Fulphila. Here we are hovering in high single-digit market share, and you obviously mentioned some of the reason behind that. Looking ahead, with the kind of manufacturing capacity we have and the marketing outreach which our partner might have achieved so far, potentially what kind of market share we can gain in these two key products? I can respond to that, Damayanti. I think we wouldn't want to comment on specific market shares. I think that wouldn't be fair. We've really looked at the past. We've been able to hold on to a steady market share overall, and it's really been moving upwards despite the competition that we've seen. We've really seen our partner, Viatris, been able to navigate the increasing competition, as well as the other products which have entered that space over time. We believe that these are our products, as rituximab joins our portfolio, it will only strengthen our position that we have in the U.S. overall. We would remain optimistic as to how Viatris has held on to this and we remain positive about how they will pursue it in the coming year. Okay. Thank you. My second question is again on biosimilars. Can you specify the broad sales split between the emerging market and developed market as of 2Q? On the emerging market side, what kind of growth we should be anticipating in next few quarters? Related to that, sequentially, biosimilars sales were, I’ll say, largely flat, but we have seen good pickup on the margin part. Can you also please explain that? Shishir, do you want to go on the split, and then maybe Shishir can add on. Sure, I'll just share the numbers around the split. For Q2, we have developed markets going towards the 50% mark. It's just above 45%, 46%. The second question was the margin improvement. Yes, the margin improvement reflects the higher profits, as Kiran mentioned, that's played out from the developed markets. What will be the key driving factors which we should be looking for? Damayanti, I just want to answer that question of yours by saying that I've already mentioned that the second half will get bolstered by, obviously, insulin glargine, and we also expect there is the improvement in some of the other, all the biosimilar portfolio. I think the main spurt of growth will come definitely from insulin glargine. Ma'am, even in other emerging markets, because I was specifically asking for growth drivers in the non-developed markets. Yeah, that continues to grow. I think, Shishir, you might want to comment on that. The first half in the emerging countries, we have seen good growth and we have got a demand book that is full in the different countries that we operate. I'm also very optimistic that the growth trajectory will continue the same way it was in the first half for the other emerging countries. In India too, in the first half we have seen very good growth, and we hope to continue that growth trajectory as well. I would keep the trend of the growth more or less similar as it was in the first half. Thank you for your response. I'll get back in the queue. Thanks, Damayanti Kerai. Next question is from Yash Khanna from Hott Advisory. Hi, good morning to you. My first question is, I know that we have a very small business in India, but I would like to know the impact that we have due to the insulin glargine coming under NLEM. Like how much price cut we have in% for the product, and with the decreased price, can we expect the volumes to go up for the product, like higher adoption for the product? Shishir, why don't you field this question? In India, the insulin business, the bigger part of the business in India is still the human insulins. If you look at the analog business, it is about 20% of the patients that is there in the market. There is a huge scope for the analog business, is one. The second, our own business in this particular area. We are not promoting this product only in terms of price differential, that is very clear. Though we have a price differential from the leader product in this, we are promoting our product strongly on quality. Whatever the price decrease will come in, we have got 2 SKUs that are unique in this market, and that is the vial SKU of 5 and 10 ML, in which the price differential will continue to be there. We have got a significant advantage here, and I don't think the NLEM, in terms of what the leader price will come down, will impact us that much. A, there's a huge scope to gain market share from the human insulin. B, we continue to focus on the high quality and the interchangeability that we have got in the U.S. will give us that further impetus. Though the same rules don't apply in India, but it definitely gives more confidence to doctors that what we have with us is a very high-quality glargine. We have seen the 2 months, the traction definitely has improved. I'm very optimistic about this entire business of glargine of our brand Basalog in India. Thanks, Yash. The next one. Yash, do you have any follow-up questions? Yeah. I got muted, sorry. Yeah. My second question is on our Visakhapatnam greenfield facility. We have invested INR 600 crores in the facility, I would like to know what would be the approximate asset turnovers for the facility. We said that we can get approvals by FY 2023, when can we expect significant revenue to start flowing in from this facility? Yash, we cannot give guidance in terms of what revenues would be generated from this facility. All that I can say is immunosuppressant is a very important growth driver and a differentiation factor for the generics business, and today we are capacity constrained in our Bangalore facility and the additional capacity that we will get from Vizag would drive the segment growth in the coming years. Now, what we said is that the commissioning would get complete by end of this fiscal, followed by validation and filing in the next fiscal. Then it will be followed by FDA inspection and approval. We expect the commercialization to start somewhere in calendar 2023, if everything goes as planned. Okay. H2 FY 2023, if everything goes as planned. Yeah. Thank you so much. Thanks, Yash. Next one is from Shyam Srinivasan, Goldman Sachs. Yeah. Hi, hope I'm audible. Good morning, thank you for taking my question. Just from a logistics perspective, if I unmute, I think the participant cannot mute back. Maybe, Nikunj, if you can keep that in mind. Let me ask the two questions, and then pause after that. First one is on CMS pricing data for biosimilars, came out very recently for 2Q. If you see the products that have been seen the maximum QOQ erosion, have been the products that we are there or potentially going to be there, like Herceptin, Avastin, Neulasta. Largely on the onco space, somebody like Celltrion has been very aggressive in terms of taking prices down in Herceptin. Just while there is the angle of volume share gains for us in through this next 6 months and then calendar year next year, just want to understand how are we placed in terms of pricing, and in terms of cost competitiveness, especially against Asian manufacturers. That's question 1. The 2nd question is on the small molecule generics. I think you've seen another weak quarter. Just want to understand what's happening in terms of price pressure. When do you think we will likely see some kind of a bottoming out and things improving? Let me pause there. Thank you. Maybe Shreehas and Abhijit could take these 2 questions, starting with Shreehas. Sure. Shyam, I think the CMS point actually is absolutely valid, and we've seen that our discussions, Biocon has been in active discussions there. While we do not see a direct impact on our margins overall, we do see the amendment situation there, given that our products will come up for that, take off of some of those benefits, particularly on the reimbursement side. To address the question of cost competitiveness, I think we feel fairly or we're quite confident on the cost competitiveness, even the Asian partners for that matter, other peers in that group because we've conventionally been a strong emerging markets player for several years, whether we were in the small molecule space in the past and in even today. We've always been very cost competitive. We've always said that we've been emerging markets first, we've succeeded in our small molecules business, in our insulins business. As we now get to the U.S. and other parts of the developed markets, we believe these will be more remunerative opportunities for us than what we've seen in the past. These are things that we're not really something where we're concerned about. We of course, are vigilant on the cost competitiveness part but nothing that we are overly concerned about at this point. I'll let Abhi respond to the small molecules question. Thanks, Shreehas Tambe. Good morning, Shyam Srinivasan. Shyam Srinivasan, on your questions about the price erosion that we are seeing and the performance on the generics formulation business. The only market we are commercial right now is the U.S., and the portfolio that we have is also quite limited. Right now we have seven products commercial. Some of the products that have been commercial, we've consistently maintained a market share between 15%-20%, but there has been some pricing headwinds on that. Despite that, we've maintained our market share. However, the launch of molecules like everolimus, as we expand the portfolio with more complex products, I think we can start seeing some growth coming in from these markets. As other markets also open up in the near future, for us, you would start seeing some growth. The split of API to formulations remains at 80 20? Inderjeet, you would like to comment? That's right, Shyam. Currently that's at 80/20. Got it. Thank you, and all the best. Thanks, Shyam. The next one is from Shishir Jain, from Excapital. Am I audible? Yeah. My question arises from the concern that we are not able to gain substantial market share in the U.S. in the biosimilar market. Given the stellar margins that we have had and continued price competition with biosimilar business, is it not possible for the company to be aggressive on the pricing front and give up some margins temporarily to gain market share and make this a sustainable growth story for the company? Let me answer that by saying that, look, Viatis is absolutely focused on making this into an important business growth driver for their business. I think what we have seen thus far is basically making sure that we are in the market with a sustainable market share, which as you can see, has been in the high single digits. As you know that there are not too many competitors. At the same time, I think we are confident as partners of making progress and gaining greater market share in the coming quarters and years. I think this is a patient business building kind of phase where I think once we are entrenched in that market with biosimilars. As you know, biosimilar uptake also has now been very positively received in the U.S. Now onwards, I think you are likely to see an uptick in market share. We are very confident, as is our partner Viatris, that things will improve in the future. Your confidence has been visible for past few quarters, or I should say more than past few quarters, but there hasn't been visible market share gain. I'm just concerned, what is Viatris doing exactly to turn your optimism and your strategies into substantial market share gain? Because that has been constantly in high single digits, and there hasn't been. I think the fact that the reason why we remain confident is because you can see the interchangeability label that glargine secured certainly should give you confidence that our insulin business is likely to actually benefit from this particular approval. As you know, aspart will be the next product to follow. Our insulin segment is getting strengthened with these approvals. As you know, the Express Scripts announcement of including Semglee into their national formulary is also a very important step in this direction. Similarly, I think you know that we are awaiting our approval for bevacizumab. This is something beyond our control. The only step remaining is a pre-approval inspection. We had asked for a waiver, but U.S. FDA has not agreed to that. As soon as the facility is approved, we hope to receive approvals soon thereafter. You need to have a portfolio of products, which we do have. It's unfortunate that COVID disrupted some of our strategies, but we remain very confident that in the coming future, you will see a very good uptick in market share, as Viatis also focuses on making sure that they start gaining market share. That's all I can say. We remain confident because we have the capabilities, we have the capacity, and we are vertically integrated. That's what gives us the confidence that we will be a very strong player in biosimilars. When you compare us to many other companies who are playing in this field, they are not vertically integrated. Except for a few, there are most who are not vertically integrated. Therefore, we believe that we do have a very strong reason to be confident that we will succeed in the near term. Shish- I have just one last question. Just as we have interchangeable status for Semglee, do all biologics can have an interchangeable biosimilar? If yes, what happens to our market share when other players get interchangeable status for the products that we are not interchangeable in? Do we still sustain our market share in that scenario? Interchangeable labels have also been given, as you've just heard, adalimumab has also received an interchangeable label recently. I think there is an exclusivity period for the interchangeable label. We have a one-year exclusivity. You need to basically garner market share and make the most of a first-mover advantage. That is what we are trying to do with the interchangeable label. Just to add to what Kiran said, Shishir, interchangeability also is a high bar. It's not something that's an easy access. There's a requirement for IP of analytical characterization showing that your product meets to the expectations that have been set by the agency. Of course, together with Viatris, Biocon Biologics has set that bar, and we've paved the way for an interchangeable insulin including access, and there will be others who will follow. Like Kiran said, it is something where we carry an exclusivity period. This is something that's not easily accessible unless you have the scientific credibility to get past that bar. Okay. The next question from Tushar Manudhane from Motilal Oswal. Thanks for the Sorry, Tushar, your line is not clear. Am I audible? It is audible, but there is some. Am I audible now? Yeah. Just on this assembly, while we are having own production as well as interchangeability exclusivity, would like to understand, we are also going for the authorized version as well. Could you repeat the key benefit for me once again? Tushar, can you say it again? I couldn't hear your question. No, the question was that you got both Semglee and an authorized generic. What is the strategy of that, Tushar Manudhane? Tushar, I think these are adopting product that we launched in the U.S. market. Viatris has brought this to the market. Basically, this is a commercial strategy to allow as broad access as we can to patients in the U.S. or people with diabetes in the U.S., as much as whether they are availing insurance plans, their co-pay coverages, their payer preferences and coverages. I think the intent is to see how we can maximize reach of the product, regardless of how the patient is placed. Viatris, of course, will be best placed to respond to it, but the intent is to see how we can make the product accessible to a wide section of people, whether they are covered through the formulary or limited their footage to a lower ceiling. That's the real intent behind the two products. Manufacturing the authorized version? Yes. Biocon will be manufacturing the authorized version? Yes. Okay. Secondly, we would like to also understand while we have a good pipeline of insulin glargine, aspart, and bevacizumab, would you like to share the other potential molecules for FY 2023, 2024, maybe 2025? We've talked about a bunch of products, Vishal, which are the insulin and insulin analogs. We've also shared that we will be looking to bring our recombinant human insulin, which is right now approved in over 40 countries of the world, to those in the U.S. as well, and we look forward to adding that to our portfolio shortly. In addition to the basal insulin, which is glargine, we will add a rapid-acting analog in aspart, which is with Viatris, and then we will bring in our own recombinant human insulin following that. Got it. Just one last on the generic side, while there are intense pricing erosion, as being commented, but at the same time, if I look quarter-on-quarter, PBT margin has improved 300 basis points. If you could just explain that point. Is that to you or is that me? I don't know. Yeah. I think the quarter-on-quarter margin is largely reflected due to the product mix. I think operationally our base has remained similar to quarter one. I think it's purely a play of product mix. Okay. Thanks. That's it. Thanks, Vishal. The next one is from Ankush Agarwal from Surge Capital. Hello, am I audible? Yes. Yeah. Hi, morning, everyone. Just one broad question on the whole biosimilar business. Biocon has been an early mover in the business, right? From identifying the opportunity early on, getting into the partnership, getting the product development, getting approvals. How do you think we have done or fared on the commercialization part of it, right? Either be challenges that we have faced either through our end, our partner Viatris end, or from a market development perspective, how do you think we're going to change our strategy going ahead? Maybe, Arun, you'd like to take this question. Can you repeat the question, Ankush? I couldn't hear you. I think maybe the other people should be on mute because I'm getting an echo. Yeah. The question was, how do you think Biocon internally have fared when it comes to commercialization strategy till now, right? Broadly. I'm sorry. I think somebody else- No, he says, how do you think Biocon has fared on the commercialization strategy for biosimilars, given that we were the first to enter this field and do everything to get approved? That's your question, right? Right. I think there is a problem with my audio from this end. I'm not able to. Sorry, I'll get back. Let me see. Okay. Maybe, Shreyas, you might want to answer. Let me try and respond to your question, Ankush, as Arun fixes his line. I think the important piece is to see the way we've developed these products and brought them. These are long gestation opportunities, as Kiran talked about, and the way we've brought these products first to emerging markets and then to the EU to broadly bucket this opportunity, and let me talk about how we brought them to the U.S. first with our partner, Viatris. I think it's been a very successful launch. In fact, when we brought in Fulphila, it was the first biosimilar to have been launched in the U.S. market. It was probably the most successful launch of a biosimilar ever in the U.S. Since then, we've also been able to value maximize that opportunity in the U.S. and continue to hold a high significant market share by preserving value for us. In terms of how we progressed with trastuzumab, we were slated for a risk-free launch until Amgen did jump in with the at-risk launch. Viatris was caught by surprise by that, but it hasn't taken away from how we've gradually inched our market share towards double digits now in the period since we've launched. Again, we've preserved value, we've preserved margins. The markets remain same. There was this insulin glargine launch and approval that we got, and the timing of that approval in the U.S. meant that we missed the formulary cycle for calendar 2022 because that was between that July and October period. Since our approval happened subsequent to that formulary discussions or negotiations, our calendar 2021 has essentially been in the retail space. Now that it's opened up for calendar 2022, you can see that Viatris has really made good progress and got us listed with the preferred status in one of the biggest PBMs. I would say we've had a fairly successful approach in probably the largest market in the world, and with the products that we brought to the market. There is no switch that will suddenly bring market share, which takes time to build. We've seen, I think there was a previous question, I think it was Shish was asking, why can't we build it suddenly, sustainably, and is pricing the only lever that you have? Pricing is one of the levers, and we have been very competitive on that, as I responded to Shyam. I think beyond that, there are several other factors to be commercially successful, which is the order of entry or the payer strategy to payer access, and importantly, what is the cost of acquisition of that portfolio and the particular customer. Viatris has balanced all of this very well, and if you look at how that business has increasingly grown. Like Jimmy said, is now that entire portfolio is about 50/50 of what we were since the time we brought these products into the market, the split between developed and the emerging part. I think overall, if you look at it, we've progressed well, I would say in a gradual but steady pace. In the emerging markets, where our teams have commercialized the product through partners, I think we've seen phenomenal progress there as well, whether it is the markets of Latin America, where our trastuzumab brand through our partner Libbs, which is Zedora, is the largest brand in the country for trastuzumab. In Mexico with our partner in PiSA for our recombinant human insulin, or with Malaysia, where we have over 60% market share in that market through a distributor model. We've changed models to different markets, including how we get access to patients over time. It is a longish answer to your question, but I think the commercialization has been through different avenues, which is successful in the market, which works best in the market that we are operating in. That's really the summary, Ankush, of how we've gone about getting our products to patients. Right. Thanks. That was a very broad answer to it. Do you think the market formation has shaped what our expectations were to say five, six years down the line, like earlier? Do you think that based on this current status, you will modify your expectation for the future products that we are going to launch? I didn't get the full content of your question, but I think what you're saying. I think what I'd like to respond by saying is, please don't cut and paste the generics model with the biosimilars model. I think we have to build the biosimilars business just as the way Shreyas has described it. It is a very important business which requires a different set of factors to address. I think we are very confident that we have understood what it takes to build a biosimilars business, and we remain very confident that this will be a very large and significant business for the group. For Biocon biosimilars, we certainly believe that this is going to be a biologics. It's certainly going to be a very successful business going forward. I think you must understand that you need to build a very strong foundation before you really start getting a good uptick in terms of what you're trying to do. I don't think we are disappointed. I think we know what to expect, and we're addressing these expectations very meticulously. Thanks, Ankush. I think we'll move on. That was very good. Thank you. Thank you. The next question from Sameer Baisiwala from Morgan Stanley. Hi. Good morning, everyone. Thanks for giving me a chance. First question is on your virtual PAI that has been done for oral solid in Bengaluru. Can you give some color on that in the sense that typically it would be for 1st generic, complex, high-value product. Is that the case with you as well? Sameer, it is for a product where there are very limited number of players in the market. That would have prompted FDA to oblige us with this remote inspection evaluation. Is it a large market in dollar terms or? Not very large, I would say. Abhi, maybe you want to add some context there. Sorry, I was on mute, Siddharth. Yeah, it's not a very large market. It's upwards of $500 million with limited competition. Okay, great. Thanks. The second question is on Semglee. Have you had any advantage on the vial side because I think you are the only player on that? Does the commercialization contracts both for pen and vial go hand in hand? The second is, would it be a fair expectation that you get to a double-digit market share over the next 12, 18 months? Your thoughts on that. Let me respond to that, Sameer. I think the opportunity with the exclusive formulary listing that Viatris has secured is for pens and vials both. We would, in that sense, be the only one outside of Lantus which had that. It clearly creates a unique positioning, and we see an uptick in that particular SKU, clearly. That's different from what other products have performed, particularly base Basaglar. On the second question, do we see our market shares moving up? I think I couldn't specifically comment on what that would be, but it's fair to assume that they will move north of where we are today. I think it is safe to say that certainly the aim is to be in the double-digit growth category, market share category. Okay, that's great. Just one or two more. Update us on the pipeline of new biosims entering phase III. I think there was expectation that there would be couple of them in this current fiscal. Second is for Aspart, what's the realistic timelines that you think you'll be able to get approval and launch the product? Yeah. For aspart, as Kirin said in her opening remarks, I think that they have clearly hosted the inspection. FDA has visited us. We did receive a Form 483, we have those 6 observations we feel very confident about. We've responded to those observations with solid CAPA actions, which we believe the FDA will find acceptable. We are looking at an approval at some point in time, sooner than later. That's about aspart. In terms of your other question, which was more related to products coming to the clinic this fiscal, I think we are on course to deliver on that, and we should be discussing them and the progress of our pipeline with you as we get onto more discussions like this. Shreehas, would you say aspart is for 1Q 2022? Is that a realistic expectation calendar? From an approval standpoint, yes. I think launch strategies would certainly depend on how we Viatris sees this and how we position it. I think we Viatris would also have to view the formulary cycles like we did in case of glargine. We'll have to be mindful of that as we bring insulin aspart also into the market. Okay, great. Thank you so much. Thanks, Sameer. The next one is Prakash Agarwal from Axis. Yeah, hi. Thanks for the opportunity again. I got muted somehow. My second question was on the cost aspect. We've been hearing a lot of increase in raw material prices, solvent prices, as well as power costs. As a company, what we are witnessing now and how well we are positioned for the next 6, 12 months from a raw material as well as the operating costs like power, et cetera? Shreehas and Siddharth, can you take it? Sure. From a power cost perspective, we do not see any impact. In fact, we are looking at rationalizing our power cost as we move to green energy, more the dependency on wind and solar rather than conventional energies, where we definitely see a benefit coming in. As far as the raw materials are concerned, I think it's more than the raw material, it's the solvent where we have seen the prices go up over the last 6, 9 months, and that definitely impacted our margins. The KSMs and raw materials, we have not really seen any drastic upward or downward movement coming in from China or even the other vendors in India. Shreehas? Yeah, I think you covered it, Sid, on that part. I think the only nuance to the biologics business would be specifics where you would need single-use materials or specific media components where we've seen supply slowdowns, I would say. That's really been something that our supply chain team's really been working hard at preserving. We do not see any major concerns to our ongoing operations, and we've not seen anything that we are really overly concerned about, Prakash, so far. How do we read the increase in inventory? I mean, is that to protect the future increase in prices, or is it to protect the supply chain, or would we consider both? It would be a mix of both. I'll let Chidi comment on it. It is a mix of both. Clearly, there was a lot of anxiety in the months which were leading up into the pandemic, and there was a requirement to somehow definitely kind of stock up on a lot of these things. We see that easing up overall as supply chains world over start relaxing a bit. We also are looking at product launches. We would see some of that building up. Fair to say it'll be a little bit of both. Chidi, if you would like to add something or anything overly concerned? Yes, you covered it. It is mostly the supply chain aspects, Prakash, and with the buildup for Q2. Okay. You mean the launch or the market share in terms of what we're expecting across markets, it could be because of that as well? Yes. Generally, we are expecting to see sequential growth quarter-over-quarter and set up nicely for FY 2023. Part of the inventory build-up is towards that. Okay, got it. Thank you, and all the best. Thanks. Thanks, Prakash. Next one, Surya Patra, PhillipCapital. I was trying to understand, whether you have seen any kind of advantage in terms of gaining better or expansion for your other products, getting more inclusion in the various incremental formularies for the older product, given the benefit or advantage of interchangeability, what we have seen in case of glargine. Let me reframe the question, please. Sorry for that. We have seen interchangeability at approval for glargine. Now this will be a demanded product from us. Whether this is giving any advantage to the other old product in terms of penetrating faster with new contracts or new customers like that? No, I don't quite follow that. Vimal, would you want to respond to that? If you could hear that, Surya's line has been a little- I think- Static on that. I think, Surya, you're asking if there are synergies between the commercialization of interchangeable glargine and the other oncology products which we have. Does an improvement in glargine also supports the improvement in the Fulphila and Ogivri. Is that your question? Exactly. Vimal, if you look at our current relationships that we at least have with some of these major formularies, Fulphila is listed with some of these PBMs in some way, and we have those ongoing relationships. Of course, this kind of a preferred listing with a formulary as large as Express Scripts will have positive knock-on effects, not just on other products in our portfolio, but even potentially with other customers. These are things which we can't necessarily comment on how those will play out. It's basically intuitive that some of these things will have synergistic or positive knock-on effects overall. To really say that this is what will happen, I think would be very difficult, Surya. Okay. Similar question on, let's say Fulphila, what we had seen last quarter that U.S. FDA highlighting the artificial volume gain what the innovator has witnessed over the years because of the Onpro kind of marketing. After that, did you see any kind of advantage in terms of more better penetration for Fulphila? We certainly have always maintained that the device itself doesn't probably offer any meaningful benefit to patients. That's something that we've always been of the view. Clinically, it doesn't offer any benefit. There's certainly some benefit on the convenience, and it certainly did hang on to a longer market share during the pandemic. You're seeing that come off now, and you're seeing that erode. We certainly feel that the syringe market will overall benefit, which is where we are currently operating in. We certainly see some positive effect of that, Surya. Okay. just last question on. If you don't mind, if you can get back to queue, because in the interest of time, we'd like to cover everyone else, if that's fine, sir. Yeah. Thank you. The next question is from Charulata Gaidhani from Dalal & Broacha. Charulata, please go ahead. Yeah. My question pertains to the difference with adalimumab getting interchangeable status. How does it change the market dynamics, and what kind of volume growth you can anticipate in the market? We wouldn't necessarily want to comment on competition here, the adalimumab biosimilar interchangeable approval that Boehringer has been able to secure, they've, of course, been ahead of the pack in terms of what is publicly available in terms of dates. We certainly feel that this is a positive development overall in terms of how it will improve and widen access of the product. If you really look at it, HUMIRA is a large opportunity overall, and we believe that it will only get better in terms of how this will be explored by all the biosimilar players, including Viatris, who has a large play there. We see this overall, Charulata, as a positive development in terms of acceptance of biosimilars. In general. Okay. My second question pertains to the Serum deal. By when do we expect completion and the funds moving into Biocon? Let me start just by saying there are no funds moving into Biocon, but we expect to see this partnership realizing revenues for Biocon Biologics in the second half of next fiscal. Okay. Yeah. Thank you. Thanks, Charulata Gaidhani. The next question is from Kunal Taneja. Yeah. Thank you for the opportunity. I have just one question. What would be our gross block for the Malaysia biologics facility, and what would be its bioreactor capacity? We have not revealed the capacity. In terms of investments, it's around $350 million. Sure. Thank you. Thanks, Kunal. The next one is from Harit Ahamed from Spark Capital. Good morning. Thanks for taking my question. On insulin aspart, your comment that the Form 483 in the pre-approval inspection, that doesn't impact your commercialization timelines. Just trying to understand if there are any entry barriers other than the compliance status of the facility. I would've imagined, if the inspection had gone well, we would have had an approval by now and launched sooner. Are there any patents or something else that's blocking? I think you should be corrected in your perception of what you just said. Okay? First and foremost, as you know, the inspection was not possible because of COVID for all this time. We were able to persuade them to come and do an inspection at the Malaysia facility, which they did in September. It doesn't mean, if they had been able to come earlier for the inspection, we could have gotten earlier approval. There is no linkage to the inspection and approval timeline. Approval takes place of a PAI inspection. It takes a specific period of time, and that is why I think even Shreehas confirmed, I think, to Sameer, that we expect approval in the first quarter of next calendar year, which does not necessarily mean that we will immediately see an uptick in terms of commercial opportunities, because it is all linked to contracting cycles. If we are able to enter into a contracting cycle, in that period of time, obviously it means that we can immediately start with our commercial entry into the U.S. market. If for some reason we have to wait for a few quarters, so be it. I think you should not assume I mean, your perception that the inspection is delaying approval is not correct. The inspection had to take place. Yes, it could have taken place earlier, but COVID did not allow travel, and that was the only reason why the inspection was not done till September this year, and that too, we persuaded them as a special request saying, "Please come inspect us," and they agreed. All right. Thanks for that. My second question is on Bicara Therapeutics. We had talked about plans to raise funds at that entity. Any updates there, and do we still maintain our guidance of no more funding from Biocon beyond the $40 million that we've already done? They are in the process of raising funds. We will provide some basic funding to keep their operations going. Beyond that, we are not funding them at such a large level. Thank you. The last one from my side. There's an exceptional item related to modification of the optionally convertible debentures of a PE investment in Biocon Biologics. Can you give more color on this, what exactly this is about? Harit, hi. I'll take that question. Yes, there's been a modification in the terms. No change in the equity stake, but because there's a modification in the terms, the unamortized cost with respect to the investment had to be expensed off in line with the accounting standards. No change in the equity stake that it will convert to. Okay. Thanks, Sunil. That's all from my side. Thank you. Thanks, Harit. Next one is from Vipul Kumar Shah from Sumangal Investments. Am I audible? Yes. Yeah. My question is to Kiran, ma'am. This is regarding our deal with Serum for this vaccine. Is it a asset admission on our part that we are seeing growth saturation in biologics business and we don't see any meaningful growth prospects for biosimilar business? How should we read it, ma'am? No, I think let me explain the whole rationale behind the Serum deal. As you know, our objective of the Biocon business is to make global impact on global healthcare. I think all this time, we were only focused on non-communicable diseases, which certainly has a huge need and a huge unmet need. I think nobody had really looked at communicable diseases as an area where there was a huge need globally to handle global healthcare. I think the pandemic brought the attention to the huge impact of viruses and other microbes in terms of disrupting global healthcare, which we ourselves felt was very important if we wanted to be a comprehensive play in terms of making impact on global healthcare. We felt that this was also a good adjacency for us because of the fact that vaccines can be a very good bolt-on business to us. That is the reason why we believe that this is a very good alliance, which gives us an entry into this business. There is also a huge need for developing antibodies for infectious diseases as well, and that's why we believe that this was a very good partnership and alliance. It doesn't take away from the fact that you need biologics for many unmet needs in non-communicable diseases. I hope you understand that it is not to take away from non-communicable diseases, but to make sure that we also have communicable diseases in our portfolio as something to address. Because both these areas do have unmet medical needs, which are being served by biologics and also now with vaccines. For a long time, I think the vaccine space was stagnating because there was no need for addressing any of these kind of viral diseases. Today, the spotlight on viral diseases and their disruptive impact is being felt, and we felt that we also need to be there. Ma'am, are we open to venturing into manufacturing of vaccines at a future date also? Well, I think we've already mentioned that in our alliance that Serum Institute and Biocon Biologics will enter into research programs for next generation vaccines. Okay, ma'am. Thank you and all the best. Thanks, Vipul. We're just getting over time. Maybe we'll just have one quick question from all the three left and then we'll close. Tarang from Woodbridge Capital, you can go next. Hi, good morning. Congratulations on getting the interchangeability status and approval through Express Scripts. Actually, I had three questions, but I'll just probably start with one. What proportion of the overall glargine volumes in North America would be currently driven through the Express Scripts signal network? Roughly in the region of about a fifth or a fourth, in that region, somewhere in that place. Okay. Can I just squeeze in one more, please? Sorry, Tarang, we just want to give opportunity to everyone, and we can, of course, take those questions offline if it's fine. Sure. Thank you. The next one is from Satya Keerti. Move on to the next if people are not able to. Okay. The last one is from Sonal Gupta. Yeah. Good morning, and thanks for squeezing in my question. I just want to understand like HUMIRA, we've seen Boehringer had done switching studies. I just want to understand what would be the cost of if you were to pursue something similar for your mAbs where you have interchangeability, what would be the cost of doing a switching study? Sonal, each one of these studies would be different depending on the product you are trying to do it for. It would vary depending on which reference product you are generating the study for, the period for which that you are conducting the study, the number of switches that you would need to conduct before you can claim absolute switchability. It would change from product to product for all these chronic therapies. More importantly, you have to see, given the current guideline status, that it's only the first one to make it past the line who can really benefit from it given the one-year exclusivity period that they will enjoy. This particular study was known for a while. It was obvious that if they were to make the cut, then really anybody else conducting a similar study would probably not benefit from that anyway, because there could be now an exclusive status that the first one past the line would enjoy. It is really in that context that you have to view these kind of studies. Okay. Thanks a lot. Thank you. Thank you everyone. I think there were a few more questions, but we request you to reach out to Aishwarya or I, and we can help you with the responses. Given we are over time, I think with that, we would like to conclude the call and we look forward to seeing you again next quarter. Have a good day. Thank you.