Good morning, everyone. I'm Aishwarya Seetharam. 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 FY 2022. 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 Should you need to raise questions, please select the raise hand option under the reactions tab of your Zuba 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 Doctor. 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 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 Nikhanshu. Now, I'd like to turn the call over to Doctor. Kiran Madhonda Shaw. Over to you, ma'am.
Thanks, Aishwarya, and good morning, everyone. Welcome to Biocon's earnings call for the Q2 and first half of FY 'twenty two. 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 1,000,000,000 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-nineteen 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-nineteen through our portfolio of remdesivirritolizumab and cytosol. And we have added to this effort through our collaboration with Adagio Therapeutics for their novel antibody therapy, ADG20, and thereafter with Serum Institute Life Sciences for vaccines. And this certainly takes us several steps further in strengthening our portfolio of therapies for the treatment and prevention of COVID-nineteen. 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. Doctor. Eric Mazumdar has been appointed as Non Executive Director to the Board of Biocon Limited with effect from November 1, 2021.
Doctor. 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 Cancer Research. Doctor. 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 Coming to business highlights, Let me now take you through the key highlights of this quarter. Before I talk about Evolimus, we did see a launch of labetalol hydrochloride tablets And ezomiprazole magnesium delayed release capsules earlier this quarter. But of course, the most significant Launch was that of Evolimus tablets, a generic version of ephenitor in the U. S. On as a day 1 launch on the 1st October.
We expect that this will significantly drive the growth of our generics portfolio in the second half of this fiscal. Another bit of important news was The approval that we received as for the world's first interchangeable biosimilar from the U. S. FDA for our biosimilar Glargine Semgry, 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 Insulin segment.
We had earlier reported that we had entered into a strategic alliance with Seagram Institute Life Sciences to foray into vaccines by committed access to 100,000,000 doses of vaccines annually for 15 years, in exchange for approximately a 15% stake in Biocon Biologics at a post money valuation of RMB4.9 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-nineteen 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 INR1945 crores versus INR1765 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 and D spend of INR165 crores for this quarter, which is very similar to that of last fiscal, which corresponds to 13% of revenue ex Syngene. Of this, INR146 crores is Expensed in the BNL, 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 and 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 INR551 crores, a growth of 35% year on year. The EBITDA margin stood at 28% as against 23% reported in Q2 FY2021. Profit before tax or PBT for the quarter, excluding an exceptional charge of INR 70 crores, stood at INR276 crores, up 27% versus INR218 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 INR5 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 INR188 crores versus INR169 crores in Q2 FY 2021, which represents a growth of 11%. After adjusting for exceptional charge, net profit stands at 1.38 crores. Now let me turn to the performance of our business segments 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 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 degrowth of 12% over Q2 FY 'twenty one. The quarter's PBT was at INR50 crores versus INR70 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 FY 2022. Lamatulol Hydrochloride tablets and esomiprazole magnesium delayed release capsules were launched earlier in the quarter. And following this, we launched Evololimus tablets, a generic version of epinitor as a first day launch on October 1, 2021.
This is the first Day 1 launch for our generics formulation business and Evironemis is a prescription medication that is used to treat certain types 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 A ANDAs. The final closeout report from the agency is awaited. Our greenfield immunosuppressants API facility, manufacturing facility in Visakhapatnam remains on track on to be commissioned in the latter part of FY 2022 with qualification and validation in FY2023.
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 FY2023 onwards in terms of our generics business. Coming to novels, Equilium, our U. S.-based partner, has announced plans to initiate a Phase 3 pivotal study for the use of vidulizumab 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, Baikara Therapeutics, continued to make progress in the dose finding Part of the Phase 1 trial for its lead program BCA101 as a single agent and in combination with the PD-one inhibitor. On the basis of the current progress, Baikara anticipates declaring the recommended dose for expansion by the end of calendar year 2021. Now coming to biosimilars. Biocon Biologics recorded revenues of INR 743 crores 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 INR303 crores. This includes the revaluation gains made from the equity investment in Adagio at the IPO. Core EBITDA margins excluding R and D, Forex Licensing Income and Adagio Revaluation gains stood at INR304 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 1st 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 Biarchis. Our partner Biarchis plans to transition the current product to the 3.51 ks 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 28,000,000 lives. As a result of this, we expect Sembry 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 the CARPA 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 1 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 will continue to see steady improvement. In Q2, our biosimilar bevacizumab Ebevme 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 So in Aspart in Canada. We have also made A strategic move into communicable diseases through 2 key partnerships, 1 with Serum Institute Life Sciences for Vaccines and infectious disease antibodies and the second with Adagio Therapeutics for a novel COVID 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-nineteen 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-nineteen 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-nineteen.
This entails manufacturing and commercialization in several emerging markets including India. ADG20 is being developed for the prevention and treatment of COVID-nineteen as a single dose intramuscular injection. It has the potential to effectively neutralize a broad range of SARS coronaviruses, including SARS CoV-two and its emerging variants. The company is currently conducting its Phase twothree pivotal trials to support an emergency use authorization application by the Q1 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, Yes, which is really the Syngene business.
For Q2, revenue from operations was up 17% to INR 610 crores from INR520 crores last fiscal. Profit before tax excluding the exceptional charge increased to INR113 crores versus INR94 crores. The Q2 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 MDSB during the quarter, although the volumes are dropping as the impact of vaccination reduces the need for treatment 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. So 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 would like to remind everyone, in case you need The first question is from Prakash Agarwal from AXIS Capital.
Yes. Hi. Good morning, ma'am, and good morning to team. My first question is on Yes. So from an outlook perspective, you mentioned second half is looking better obviously and that insulin large The interchangeability and with the higher with Express Script 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 Beva, which is awaiting the approval, what are the timelines there and Esparte. So basically ex insulin glargine, because insulin glargine is I think pretty much Set for its growth path.
So Prakash, I'll just answer some of those questions and then I'll sort of leave it to Shir To answer the rest, basically, I think you're right. I mean, bevacizumab is an approval. We are very Eagerly awaiting. And 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, many product approval delays in the U.
S. And we happen to be one of them. So we do hope that this inspection will happen sooner than later. We have tried to get them to Even considered a remote inspection, but we will get keep you informed as soon as we get any information. I think the rest of the questions, I will leave it to Shreyas to basically respond.
Thanks, Kiran. I think to respond, Prakash, to the 2 Product that you talked about, particularly Fotilla and Ogilvy in the U. S. I think we've discussed this in the That we've seen in the pandemic phase that on pro, particularly in The Fulfillar basket held on to a market share, in a sense, artificially given the convenience factor as people's footfalls reduce to hospitals. We're seeing that particular market share come off from a little above 60% to the mid-50s.
And that part is Starting to move towards the synergies space, which is where we are operating. We do not want all of it moving towards Fulphila, but we're starting to see that as a positive 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 We've seen to hold the 1 position or the 2nd position, I would say, after the other biosimilar On the 150, on the 440, we've seen some competition push fast on more aggressive pricing strategies. But it hasn't really overall impacted the okay free brand strategy that Nitrous has come up with a new set of we've held on to that just under 10% market share even in the recent couple of months. And we see this as a steady positioning, which will only improve as we move along to the next fiscal.
The VersaNomab, 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 PayEx.
But Prakash, do you have any follow-up or we'll move on? Okay. The next question is from Surya Quanta from Philip
Okay. Thanks for this opportunity and good morning everybody. Just before getting into the questions, can I just get the clarity about the other interim number? Why is that so elevated? And the other income.
And quantify that, what is the kind of revaluation gain on that as you and the nature of that?
Can I clarify?
Yes, yes, please.
Surya, hi, good morning. In August, we had invested $5,000,000 In DASIO 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. Okay. Can you quantify, sir, what is that number that is there in
the 55 crores. Sure. Fine.
Okay. Just extending that, I'll let you have all these things. So the progress on the product, The AD Integrity and all that. So 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?
Yes. I think, Stairs, you can take the question.
Yes. Sure. So Sudhir, I think the ADT-twenty A product that we partnered with Adagio on is a broad neutralizing antibody. And it really has shown Very high efficacy in all known variants. In fact, recently, we published or DASA has published an in vitro study where ADG20 has really shown a very high efficacy against all com variants, including the Delta variant, The Lambda variant, the blue variant and even as other antiviral therapies are available where the efficacies 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.
And DDG 20 specifically has a very unique positioning where it's a single Therapy or monotherapy with a 1 shot intramuscular dose, which can be given in an outpatient setting, really improving the convenience of it. And the way it has been designed, it is with an extended shelf life, which offers or which is expected to offer protection for close to a year or thereabouts, which really then offers a lot of security to a wide section of population, which is at high risk for immunocompromised who were unable to develop immunity despite vaccinations. So there are 2 studies that Raju has been conducting apart from the 6 months study that they've already published in the Phase 1, where they are doing a Phase 2, 3 study. 1 is the STAMP study for treatment that I just talked about. And the other study is about eBay, which is a pivotal study to look at profile access, which should then target a very large of the population, thereby allowing peace of mind as we go along without necessarily getting infected, but kind of a shot which you can protect yourself directly without waiting for an incubation period of mix, which a typical vaccine would do.
So 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 could you clarify the markets? Yes. Shias, if you could clarify the markets we have Present, yes.
Well, yes. So we have 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, we believe this therapy can make a very big difference. I think we lost. So we are probably in touch with him.
Yes. We'll wait for him to join back. The The next question is from Dhamyantikaray from HSBC.
Thanks for the opportunity. My first question is coming back to Ogilvri and Fulphila. So here, we are hovering in High single digit market share, you obviously mentioned some of the reason behind that. But looking ahead, with the kind of manufacturing
capacity we have
and the 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 each to key products.
I can respond to that, Domencli. I think we We wouldn't want to comment on specific market shares. I think that wouldn't be fair. But 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. So we've clearly seen our partner, Beatrice, been able to navigate the increasing competition as well as the other products which have entered that space over time. And we believe that these are products, As brevacizumab joins our portfolio, it will only strengthen our position that we've had in the U. S. Overall.
So We would remain optimistic as to how Pinterest has held on to this. And They remain positive about how they will pursue it in the coming year.
Thank you. My second question is again on BioCplus. So can you specify the broad sales Split between the emerging market and developed market as of 2Q. And 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 So can you also please explain that?
Shili, do you want to go on the split and then we can maybe see that we can add on the
Devan, yes, 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.
And what will be the key driving factors which we should be looking for that?
So Ramesh, 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 blood gene And we also expect there is the improvement in some of the other all the biosimilar portfolio. So I think the main spurt of growth will come definitely from insulin therapy.
Ma'am, even in other emerging market because I was especially asking for growth drivers in the non developed markets.
Yes, that continues to grow. I think, Phil, 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. So 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. So I would keep the trend of the growth More or less similar as it was in the first half.
Thank you. Thank you for your response. I'll get back in the queue.
Thanks, Piyapudi. Next question is from Yash Tanna from Ithought Advisory.
My first question is, so 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 incident largely coming under NLEF, like how much price cut we have in percentage for the product. And with the decreased price, can we expect the volumes to go up for the product, like high adoption for the product?
Sushil, why don't you field this question?
In India, the Insulin business, A bigger part of the business in India is still the human insulins. If you look at the analog business, it's about 20% of the patients that is there in the market. There's a huge scope for the analog business is 1. The second is our phone business in this particular area. We are not promoting this product Only in terms of price differentials, that's very clear.
Though we have a price differential from the leader product in this, we are promoting our products strongly on quality. So whatever the price decrease will come in. We have got 2 SKUs that are unique in this market and that is the wireless SKU of 5 and 10 ml in which the price differential will continue to be there. So we have got a significant advantage here. And I don't think the NLM in terms of What the leader price will come down will impact us that much because, a, there's a huge scope to gain market share from the human insulin and 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, very high quality Glargine. And we have seen in the 2 months, the traction definitely has improved. So I'm very optimistic about this Entire business of Glargine of our brand Baselog in India.
Thanks, Yash. The next one, Yash, do you have any follow-up questions?
Yes. I got muted, sorry. Yes. So my second question is, so on our Vishakapatnam Greenfield facility. So we have invested INR600 crores in the And so I would like to know like what would be the approximate asset turn was for the facility.
And we said that we can get approvals By FY 'twenty three, so when can we expect significant revenue to start going in from this facility?
Yes, 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 Group 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 Viasat 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.
And then it could be followed by FDA inspection and approval. So we expect the commercial Realization to start somewhere in calendar 'twenty three, if everything goes as planned.
Okay. So H2 FY 'twenty three, if everything goes as well? Yes. Thank you so much.
Thanks, Yash. Next one is from Shamsrinivasan, Goldman Sachs.
Yes. Hi. Hope I'm audible. Good morning and thank you for taking my question. Just from a logistics Perspective, if I unmute, I think the participant cannot mute back.
So maybe Nikunj, if you can keep that in mind. So Let me ask the 2 questions and then pause after that. So first one is on CMS pricing data for biosimilars came out very Recently for 2Q. And 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 Septin, Westin, Neulasta. So largely on the Onco space, somebody like Acetrion has been very, very aggressive in terms of taking prices down in her Septin.
So 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 second question is on the small molecule generics. I think you've seen another weak quarter. So 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?
So let me pause there. Thank you.
So maybe Sherish and Abhijit could take these two questions, starting with Sherish.
Sure. So Asham, I think the CMS point that it is absolutely valid and we've seen that in discussions. Yes. This has been in active discussions there. And 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 tick off of some of those benefits, particularly on the reimbursement side.
But to address a question of cost competitiveness, I think we feel fairly On the cost competitiveness given the Asian partners or for that matter, other peers in that group, Because we've conventionally been a strong emerging markets player for several years, whether we We're in the small molecule space in the past and even today. We've always been very cost competitive. We've always said that we will We're in emerging markets first and we've succeeded in our small multiples business, in our insulins business. And as we now get to The U. S.
And other parts of the developed markets, we believe these will be more, immunoative opportunities For us, then what we've seen in the past, these are things that we're not clearly something we're concerned about. We, of course, are vigilant on the cost competitiveness part, but nothing that we are overly concerned about at this I'll let Rhee respond to the small molecules question.
Thanks, Svyaz. Good morning, Shyam. So Shyam, on your questions about the price erosion that we're 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 7 products Some of the products that have been commercial, we've consistently maintained a market share between 15% to 20%, But there has been some pricing headwinds on that. Despite that, we've maintained our market share. However, with the launch 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. And as other markets also open up in the near future, for us, you would start seeing some growth.
And the split of API to formulations remains at 80 20?
Indranil, you would like to comment?
That's right, Shyam. Currently, that's at 80.20.
Got it.
Thank you and all the best.
And Shyam, the next one is from Shish Jain from Ebix Capital.
Am I audible?
Yes.
So my question arises from the concern that we are not able to gain substantial market share in U. S. In the biosimilar market. And given the stellar margins that we have had and continued price competition in biosecular business, is it not possible for the company to be aggressive on the pricing front and give for some markets generally to gain market share and make this a sustainable growth story for the company?
So let me answer that by saying that, look, Viatrix is absolutely focused on making this into an important Business growth driver for their business. And 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 digit. 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 years. So I think you have 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. And so now onwards, I think you are likely to see An uptick in market share. So we are very confident as is our partner, Biacus, that Things will improve in the future.
But your confidence has been visible for past few quarters, but there hasn't been I should say more than past few quarters, but there hasn't been visible market share gain. So, I'm just concerned like what is Vethrish doing exactly To turn your optimism and your strategies into substantial market share gain because that has been constantly in the high single digits and there hasn't
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 really benefit from this particular approval. As you know, Aspart will be the next product to follow. So our Insulin segment is getting strengthened with these approvals. And as you know, the Express Scripts announcement of including assembly into their national A formulary is also a very, very important step in this direction. Similarly, I think you know that we are awaiting our approval for Tizumab, this is something beyond our control.
There is the only step remaining is a pre approval inspection. We had asked for a waiver, but USFDA has not agreed to that. And we need 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 But we remain very confident that in the coming future, you will see a very good uptick in market share As Viad just also focuses on making sure that they start gaining market share.
So 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 would be a very strong 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 all there are most who are not vertically integrated. And therefore, we believe that we do have a very strong Reason to be confident that we will succeed in the near term.
I have just one last question. So just as we have interchangeable status for Sendry, do all biosimilars all biologics Can have an interchangeable biosimilar? And if yes, what happens to our market share when other players get interchangeable status for the products that we are not interchangeable in. So do we still sustain our market share in that scenario?
You know, Interchangeable labels have also given 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 1 year exclusivity. We will have a 1st mover advantage. And you need to basically garner market share and make the most of a 1st mover advantage.
That is what we are trying to do with the interchangeable.
Just to add to what Kiran said, Suresh, interchangeability also is a high bar. So it's not something that's an easy access. So there is a requirement for IDP of analytical characterization showing That your product meets to the expectations that have been set by the agency. Of course, together with the interest, Biocon Biologics has set that bar and we paved the way for sustainable and still improving access. And there will be others who will follow.
But like Kiran said, it is something where we carry an exclusivity period. And this is something that's not easily accessible unless you have the scientific credibility to get past that
The next question from Kushal Muthane from Sorry, Prashad, your line is not coming. It's
audible, but there is some audible now? Yes.
So, Deepu, can you tell me if I could add your
No, the question was that you got both Semgree and an authorized generic. What is the The strategy of that rationale.
Yes. So, Kisha, I think these are the token product that we've launched in the U. S. MarketBeatrice has brought news to the market. Basically, this is a commercial strategy to allow access as broad access as we can Two patients in the U.
S. Or equivalent avenues in the U. S. As much as whether they are waiving insurance plans, their co plan, co pay Coverages, their peer 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. We are just supposed to be best Yes, to respond to it, but the intent is to see how we can make access make the product accessible To a wide section of people, whether they are covered through the formulary or limited, they have to place To a ceiling.
That's the intent behind the 2 products.
The manufacturing is authorized, was it?
Yes.
Biocon will be manufacturing the authorized version?
Yes.
And secondly, I would like to also understand while we have a good pipeline of insulin glargine, aspartum, vivacilumab, Would you like to share the other potential molecules for FY 2020 2024, maybe 2025?
So we've talked about a bunch of products, Vishal, which are the insulin and insulin analogs. We've also shared that we can 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.
So in addition to the basal insulin, which is largely, we will add a rapid acting analog in Aspart And then we will also bring in which is its BIAKOS and then we will bring in our own recombinant human insulin following that.
And just one last on the gibberish side, while there are intense filing erosion as being commented, But at the same time, if I look quarter on quarter, PBT margin has improved by 300 bps. So if you could just explain that part?
Yes. 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 1. I think it's purely a play up for product mix.
Thanks, Ashraf. The next one is from Anupus Aggarwal from Search Capital.
Just one broad question on the whole biosimilar business. So, right, Biocon has been an early mover in the business, right, from I define the opportunity earlier on getting into the partnership, getting into product development, getting approvals. But how do you think we have done more fair on the commercialization part of it, Right. Either the challenges that we have faced with our partner, the attacide 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 that question, Ankur Shailesh? I couldn't share you. So I think
maybe I should
be on mute because I'm giving an echo.
Yes. So the question was like how do you
think Biocon internally have fared when it comes to commercialization strategy now, Right. Totally.
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 I
think there is a problem with my audio processing. I'm not able Sorry, I'll get back.
Okay. Then maybe, Shreyas, you might want to answer.
Let me respond to your question, I think the important piece is to see the way we develop these products These are long gestation opportunities, as Kiran talked about. And the way we've brought these products first 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, Virtis.
And I think it's been a fairly successful launch. If you look at When we brought in Huifila, it was the first biosimilar to have been launched in the U. S. Market. And because it was probably the most successful launch of a biosimilar ever in the U.
S. Now since then, we've also been able to value maximize that opportunity in the U. S. And continue to hold high single digit market share by preserving value for us. In terms of how we progressed with Trastuzumab, we were slated for a risk free launch until We'll AnGen did jump in with the Actris launch.
So we were, we are quite surprised 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, Michelle, we've preserved value. We've preserved margins. The markets remain same.
There was this insulin largely in launch And the timing of that approval in the U. S. Meant that we missed the formulary cycle for Calendar 'twenty two because that was between that July October period. Since approval happened Subsequent to that formulary discussions or negotiations, our calendar 21 has essentially been in the retail space. But now that it's opened up for calendar 22, you can see that Viatrix has really made good progress And Gautam has listed into the preferred status in one of the biggest PBMs.
So I would say we've had a fairly successful approach in probably the largest market in the world and with the product That we brought to the market. There is no switch that will suddenly bring market share, which takes time to build. Now we've seen I think there was a previous question, I think, to Ashish was saying, why can't we bid open 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. But I think beyond that, there are several other factors to be commercially successful, which is the order of entry Or the payer strategy, payer access.
And importantly, what is the cost of acquisition of that portfolio and the particular So Beatrice has balanced all of this very well. And if you look at how that business has increasingly grown And like Jimmy said, now that entire portfolio is about 50, 50 of what we've heard since the time we brought these products into the market, the It's between developed and emerging partners. So I think overall, if you look at it, we've progressed well in a, I would say in a gradual but steady pace. And in the emerging markets where our teams have commercialized the product through partners, I think we see phenomenal progress there as well, whether it is the markets of Latin America where Our trastuzumab brand, through our partner, Libs, which is ZEDORA, is the largest brand in the country for trastuzumab Or in Mexico with our partner in PISA for our recombinant human insulin. Or with Malaysia, there will be over 60% market share in that market to a distributor model.
So we've changed models to different markets, including How we get access to patients over time? So there's a longish answer to your question, but I think the commercialization has been to 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.
That's right.
Thanks. That was a very fair answer to it. But do you think the market permission has shaped
what Our expectations were up to say 5, 6 years down
the line like earlier. And do you think that based on this current
status, you will Modify your expectations for the future product that we are going to launch?
I did get the full content of your But I think what you have said I
think the main 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 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.
But 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. So I don't think we're 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 helpful. Thank you.
Thank you. The next question from Sameer Viswala from
Hi, good morning, everyone. Thanks for giving me a chance. So First question is on your virtual PAI that has been done for oral solid in Bangalore. 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
Sameer, it is for a product where there is there are very limited number of players in the market. So that would have prompted FDA to oblige us with this remote transmission innovation.
Is it a large market in dollar terms
Not very large, I would say. Abhi, maybe you will add some context there.
Sorry, I was on mute, Sabahat. Yes, it's not a very large market. It's upwards of $500,000,000 with limited competition.
Okay, great. Thanks. And the second question is on Semglee. Have you had any advantage On the Viall side, because I think you are the only player on that. And the second, or Does the commercialization contracts both for Pen and Vial go hand in hand?
And the second is, would it be a fair expectation that you'll get to a double digit market share Overnight, 12, 18 months, your thoughts on that?
Let me respond to that, Sameer. I think the opportunity with the Express Scripts The Pongle listing that Vectrus has secured is for FEMSA and Biocon. So we would, in that sense, The only one outside of Lantus which had that. So it clearly creates unique positioning and we We see an uptick in that particular SKU clearing. So that's different from what other products Of course, particularly, Satyal.
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 not
I think it's just safe to say that certainly the aim is to be in the double digit growth category, On market share category.
Okay, that's great. And just one or two more. Can you update us On the pipeline of new BioCiMs entering Phase 3, I think there was expectation that there would be a couple of them in this current fiscal. And second is for Aspart, what's the realistic timelines that you think you would be able
to get approval in OSHA product?
Yes. So for as far as Kirin said in her opening remarks, I think the data we clearly hosted The inspection FDA has visited us. We did receive a PON4 XT and we have those Six observations we feel very confident about and we've responded to those observations with solid By actions, which we believe the FDA will find the acceptable. So we are looking at, I don't know, approval at at some point in time sooner than later. So that's about Ascot.
And in terms of your other question, which was more related to The 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 on to more discussions like this.
Shiraz, would you say aspartis for 1Q 2022, is that a realistic expectation
From an approval standpoint, yes, I think loan strategies would, Sandeep, depend on how Beatrice sees this And how we position that, I think the interest would also have to be with the formulary cycles like we did in case of large deal. So we'll have to be mindful of that as we bring Trust Builder sorry, Aspart also into the market.
Okay, great. Thank you so much.
Thanks, Sumeet. The next one is Akash Agarwal from Axis.
Yes. Hi, thanks for the opportunity again. I got muted somehow. So my second question was on the cost aspect. So we've been hearing a lot of increase in raw material prices, solvent prices as well as power costs.
As a company, how what we are witnessing now and how well we are positioned for the next 6 to 12 months from a Raw material, as you know, the operating costs like power, etcetera.
Sure, sir. Sudhak, can you take it?
Sure. So from a power cost 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. But as far as the raw materials are concerned, I think it's more than the raw material, it's a solvent, which where we have seen the prices go up over the last 6, 9 months. And that's definitely impacted our margins.
But 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. Shreyas?
Yes, I think you covered it, Sid, on that part. I think the only nuance to the Biologics business would be No specifics where you would need single use materials or specific media components where we've seen Supply slowdown, I would say. And that's really been something that our Supply chain team has really been working hard at reserving. We do not see any major concerns to our Our ongoing operations and we've not seen anything that we are really overly concerned about Prakashu.
And 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 Shruti comment on it, but it is a mix So clearly, a lot of there was a lot of anxiety in the months, which were leading up into the Pandemic and there was a requirement to see that the blend is kind of stock up on a lot of these things. You see that easing up overall as supply chains rolled over start relaxing a bit. We also are looking at product launches, so we would see some of that building up. So to your fair, we say it will be a little bit of both.
But, Chidi, if you would like to add something or Intermedia over to you, Hassan?
Yes. You covered it. It's mostly the supply chain aspects, Prakash, and with the buildup for QOH2.
Okay. You mean the launch or the market share in chart that we're expecting across markets, it could be because of that as well?
Yes. Generally, we are expecting to see sequential growth quarter on quarter and set up nicely for FY 'twenty three. So part of the inventory build up is to us.
Okay, got it. Thank you and all the best.
Thank you for taking this question. Just I was trying to understand whether you have See any kind of advantage in terms of gaining better or Consanyam, for your other products getting more, like Inclusion in the various incremental formularies for the first, for say, the older product, given the benefit [SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] It or advantage of interchangeability what we have seen in case of Hoopla Let me reframe the question, please. Sorry for that. See, we have seen interchangeability and Approval for Glargine. So now this would be a demanded product for farmers.
So 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. Would you want to respond to that? If you could hear that So your line has been, Anuj is, I think, static on that.
I think, Surya, looking you're asking if there are synergies between the commercialization And of interchangeable Glargine and the other oncology products, which we have. And does that does an improvement And Glargine also supports the improvement in the fulfill annuity. Is that your question?
Exactly. I mean, if you look at our current relationships that Viatrist has with some of these major formularies, Fulphila is, enmissive with some of these PBMs in some way, and we have those ongoing relationships. But of course, the This kind of a preferred listing with a formulary as large as Express Tips will have positive knock on effects, not just On other products in our portfolio, but even potentially with other customers. These are things which Sure. We can't necessarily comment on how those will play out.
But it's basically intuitive that some of these Things will have synergistic or positive Paragon effects overall. But to really say that this is what will happen, I think it would be very difficult, sir.
Okay. Then similar question on, Let's say, Fulfillah, what we had seen last quarter that USFDA highlighting the artificial volume gain what The innovator has witnessed over the years because of Don Pros kind of marketing. So After that, did you see any kind of advantage in terms of more better penetration for Fulfillar?
We certainly have always maintained that the device itself doesn't probably For any meaningful benefit to patients, that's something that we've always been of the view. Clinically, it doesn't offer There's certainly some benefit on the convenience and it certainly did held on to a long term market share during The pandemic. But we are seeing that come off now and you are seeing that erode. So we certainly feel that The syringe market will overall benefit, which is where we are currently operating in. So we certainly see some Positive effect from that, Sivir.
Okay. So just last question on the
If you don't mind, if you can get back to queue because in the interest of time, we'd The next question is from Charulata Gaidhani from GreenTree. Sure, Luka, please go ahead.
Yes. My question pertains to the difference with Ajlimubab 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, but the adalimumab biosimilar, you can change the approval that Boringer has been able to So they've, of course, been ahead of the pack in terms of how what is publicly available in terms of dates. So we certainly feel that this is a positive development overall in terms of how it will improve and widen access of the product. But it's if you really look at it from Aira, it's 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 Abiators, who has a large player there. So we see this overall, Charlotte, as a positive development in terms of acceptance of biosimilars in general.
Okay. And my second question pertains to the Serum deal. By when do we expect completion And the funds moving into Biocon?
Let me address this 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. Yes. Thank you.
Thanks, Chhatlifran. The next question is from Puneet Anisha.
Yes. 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. But in terms of investments, it's around the $350,000,000
Sure. Thank you.
Thanks, Kunal. The next one is from Harith Ahmed 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. So I would have imagined if the inspection had gone well, we would have had an approval by now and launched sooner.
So Are there any patents or something else that's
blocking the call?
I think you should be corrected in your perception of what you just said. Okay. 1st and foremost, as you know, the inspection was not possible because of COVID for all this time. And 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, yes, if they had been able to come earlier for the inspection, we could have got an earlier approval.
But there is no linkage to the inspection and approval timeline. Approval takes place of a PIA inspection. It takes a Specific period of time and that is why I think Umut Shreyas confirmed, I think to Sameer, that we expect approval in the Q1 of next calendar year, which is 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. But 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 requesting, please contact us and they agreed.
All right. Thanks for that. My second question is on Baikara Therapeutics. So we had talked about plans to raise funds at that entity. So any updates there?
And do we still maintain our guidance of no more funding from Biocon beyond the $40,000,000 that we've already done?
We they are in the process of raising funds and we will provide some basic funding to keep their operations going. But beyond that, we are not funding them at such a large level.
Thank you. And the last one from my side. There's an exception item related to modification of The optionally convertible debentures of a P investment in Biocon Biologics. So can you give more color on this, what exactly this is about?
Harit, hi. I'll take that question. But yes, there's been a modification in the terms. No change in the equity stake, but because there's a modification in the terms, unamortized cost with respect to the investment has to be expensed off In line with the accounting standards. No change in the equity stake that it will convert to.
Okay. Thanks, Suneet. That's all the message. Thank you.
Thanks, Harit. Next one is from Deepil Kumar Shah from Sumogal Investments.
Am I audible?
Yes.
Yes. My question is to Kiran, ma'am. This is regarding our deal with Serum for this vaccine. So 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. And I think all this time, we were only focused 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. And 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. But it doesn't take away from the fact that you need biologics for Many, many unmet needs in non communicable diseases.
So 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. So 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. But today, the spotlight on viral diseases and their disruptive impact is being felt and we felt that we also need to be there.
So, ma'am, are we open to venturing to 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.
Thanks, Rupul. We're just getting over time. Maybe we'll just have one quick question from all the 3 raised hand and then we'll close. So Tarang from Woodbridge Capital, you can go next.
Hi, Good morning and congratulations on getting the interchangeability status and approval To Express Scripts. Actually, I have 3 questions, but I'll just probably start with 1. What proportion of the overall Glargine volumes in North America Would we currently driven through the Express Script, Sigma Network?
Roughly in the region of about a fixed order of 4th in that region. So where is that, please? Okay.
Can I just squeeze in one more, please?
Sorry, Tarang. Just want to give opportunity to everyone and we can of course The next one is from Sabeet Yipri.
Move on to the next if people are not able to.
Okay. And the last one is from Sunil Gupta.
Yes. Good morning and thanks for taking squeezing in my question. I just want to understand like HUMIRA, we've seen The Boingo had done interchangeable, I mean switching studies. So I just wanted to understand like for what would be Cost of like if you were to pursue something similar for your MABS, where you have interchangeability, what would be the cost of doing a switching study?
So each one of these studies will 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. So it would change from product to product for all these chronic therapies. But more importantly, you have to see, given the current guideline That is that it's only with the first one to make it past the line who can really benefit from it given the 1 year Feasibility period that they will enjoy. And this particular study was known for a while.
It was obvious that But if we were to make the cut, then really everybody 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 could enjoy. So it is really in that context that you are looking to these kind of studies.
Okay. Thanks. Thanks a lot. Thank you. Thank you, everyone.
I think there were a few more questions, but we'd request you to reach out to Ashwari or I and we can help you with the 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.