Welcome to Quarter 1, FY27, early call of Dr. Reddy's Laboratories Ltd. We appreciate your continued interest in our company. I'm Aishwarya Saram, Head of Inventive Relations at Dr. Reddy's. Joining us today are members of the leadership team, Mr. Erez Israeli, our Chief Executive Officer, and Mr. M.V. Larasimham, MDN, our Chief Financial Officer. Our quarterly financial results have been published earlier today and are available on our website for your reference. We will start today's call with MVN providing an overview of our financial performance for the quarter. Following that, Erez will share his insights on key business highlights as well as the company's strategic outlook. We will then open the floor for questions. All commentary and analysis during this call are based on our IFRS consolidated financial statements. Please note that certain non-GAAP financial measures may also be discussed. Recalculations to the corresponding GAAP measures are included in our press release. I would like to remind everyone that the safe harbor provisions outlined in our press release today apply to all forward-looking statements made during this call. Before we proceed, I would like to call out a few housekeeping points. All participants will be in listen-only mode during the opening remarks. Should you need any technical assistance during the call, please use the chat function on your Zoom application. The chat will not be monitored for any questions to the management. The session is being recorded, and both the recording as well as the transcripts will be made available on our website shortly. Please note that this call is a proprietary material of Dr. Reddy's Laboratories Ltd and may not be re-broadcasted or quoted in any media or public forum without prior written consent from the company. With that, let me hand the call over to M.V.N. to present the financial highlights for the quarter. Over to you, M.V.N.

Thank you, Aishwarya. Greetings to everyone on the call. It is my pleasure to walk you through our financial performance for the first quarter of FY27. The business reported revenue decline of 5.6% and EBITDA margin of 12.5% for the quarter, reflecting the impact of lower linoleumite revenues, which contributed to the corresponding period last year, as well as a provision of Rs. 240 crores per inventory and other costs associated with the recent semaglutide EPA-related challenges. Notably, the underlying base business, excluding linoleumide, continue to deliver healthy double-digit growth across all key geographies, including North America, supported by new product launches and favorable currency movements. All financial figures in this section are translated into US dollars using a convenient translation rate of Rs. 94.66, the exchange rate prevailing as of June 30, 2026. Consolidated revenues stood at Rs. 8071 crores, which is US dollar's age 53 million, a decline of 5.6% year-over-year and a growth of 7.4% on a sequential basis. Strong performance across key markets, further aided by favorable forex, was offset by lower limit sales. Another revenues declined primarily due to change in operating Model Post Integration under which rebates and discounts are offered to distributors and recognized net of revenues as compared to the transition period when sales were managed by the seller Helian. This change in operating model is profit neutral. Consolidated gross profit margin was at 46.5%, a decrease of 1039 basis points year-over-year and an increase of 169 basis points sequentially. The decline in margins during the quarter was largely an account of lower limit sales, the semaglutide-API-related production mentioned earlier, as well as higher solvent costs on account of Middle East conflict. The reported gross margin was 51.6% for global generates and 4.5% for TSAI, excluding the semaglutide S.A. related profession mentioned earlier the overall margin was 49.4 while that for global index was 53.8 and for TSA was at 12.9%. The S.A. expense was at Rs. 2082 crores an increase of 12% and 4% sequentially accounting for 36% of revenues. The year-over-year increase was primarily driven by higher personal costs due to annual increments Adwords Forest Movement, targeted investments in the branded business as well as elevated freight costs arising from disruptions related to the Middle East crisis. The R&D spend was at Rs. 577 crores, declined by 8% year-over-year and up 6% sequentially, accounting for 7.1% of revenues and reflecting lower biosimilar development expenditure as compared to the previous year. The underlying EBITDA, including other income, stood at Rs. 1,009 crores for the quarter, which is US$ 1.07 million, a decrease of 14-16 basis points year-over-year and 55 basis points sequentially, reflecting a margin of 12.5% of the revenues, excluding the semi-bluetooth APA-related portion. The margin was at 15.4%. As a result, the profit before tax was Rs. 553 crores. That is 58 million US dollars representing a margin of 6.8%. Excluding the semi-glutted EPA related provisions, the margin was at 9.8%. Effective tax rate for the quarter was 21.3% compared to 26% in the corresponding period last year. The ETR for the quarter was lower primarily due to reversal of previously recognized tax provisions no longer required. and the favorable juridical mix for the quarter in comparison to the same period in the previous year. Profit after tax attributable to equity holders of the parent for the quarter stood at 443 crores which is 47 million US dollars, a margin of 5% to 5% on the revenues before adjusting for the semaglutide EPA related provision mentioned earlier. Diluted EPS for the quarter is Rs. 5.32. Operating working capital as of 30th June 2026 was 14,353 crores which is 1.52 billion US dollars, a decrease of 81 crores over 31st March 2026. CapEx cash outflow for the quarter stood at 307 crores which is $32 million US dollars. Cash flow during the quarter before acquisition related payout was negative 216 crores which is negative of 23 million. As of June 30th, 2026 we have a net cash surplus of 3057 crores which is 323 million. Foreign currency cash flow hedges executed through derivative instruments during the period are as follows. US dollar 354 million hedged using combination of Forwards Risk Reversal Options, scheduled to mature by March 2027. These contractors hedge at the rate of 92.34 to 94.63 per US dollar. Ruble 2.8 billion hedge at a fixed rate of 1.26 per Russian ruble, with maturity falling within the next three months. With this, I now request Erez to take us through The key business highlights.

Thank you NBN and good day for all of you. We appreciate you joining us today and thank you for your continued interest in our company. We remain consistent in our strategic priorities and committed to delivering growth and profitability through discipline execution as the operating environment continues to evolve. We are focused on strengthening our base business and building future growth engines in peptides, biosimilar, Consumer Health and Innovation while pursuing targeted business development initiatives to augment our organic growth efforts. The underlining base business delivered healthy double-digit growth across all key geographies, including North America. The quarter's EBITDA margins were adversely impacted by C-magnetized related challenges, including lower sales, provision for rejected batches, Loss of production, linked incentives, and other associated costs. As well as the conflict in the Middle East. Excluding this impact, we estimate that the EBITDA margin would have been in the high teens. We are working towards resolving the issue and are planning to resume semaglutide commercials applied by November. Importantly, there is no risk to any patient who has consumed the product. Patient safety and product quality remain Our highest priorities and will continue to guide us in every decision we make. We remain confident of a strong second half of the fiscal, with the resumption of semaglutite supplies. The strength of our base business and our ongoing productivity initiatives will continue to support double-digit base business growth and steady margin improvements. Let me now walk you through some of the key highlights of the quarter. We commercialize a few key complex generic products, including the anti-cancer drug Bosutinib, a first-to-market launch with 180 days of generic drug exclusivity for the 400 mg strains. and Nintedanim, a use in a treatment of lung disease in the United States. In Canada, we are the first company to secure approval for the launch of Simaglutide for the treatment of tractal diabetics. We launched Oral Simaglutides in India and remain committed to building this important metabolic franchise, complemented by nutrition offerings such as Elevita, GLP Plus, through our collaboration with Nestle. We continue to make progress bringing innovation to patients in undeserved markets through partnership, our in-license novel therapy, Plutonic Palimab. for treatment of nasopharyngeal carcinoma has entered the 100 CR Club in less than two years of launch in India. During the quarter, we partnered with Inoviva Specialty Therapeutics to develop and commercialize Xa-Eduro used in treatment of hospital-acquired bacterial pneumonia in selected markets across South and Central America, the Caribbean, Russia, and CIS countries. Through our collaboration with GARDP and our subsidiary, Origin Pharmaceutical Services, we achieved an important milestone in our access agenda by securing Thai FDA approval for Zolifluordacin, a first-in-class treatment for uncomplicated gonorrhea. The approval came just six months after the US FDA approval, making Thailand the first LMIC country to approve the product. On a regulatory front, the USFDA completed a pre-licensed inspection PLI at our biologics manufacturing facility in Bachupali, Hyderabad, in June 2026, and issued the Form 403 with seven observations, which we already responded well within the stipulated timelines. Our commitment to good governance and sustainability continues to be recognized globally. During the quarter, we celebrate 25 years of our New York Stock Exchange listing, reinforcement of our distinction as the first non-Indian pharmaceutical company listed at the exchange, as well as our commitment to global best practices in governance, compliance, and capital market access. FTSE Russell placed us as the top 1% worldwide while Times Statista ranked us 165th globally and 5th among Indian companies among the world's most sustainable companies. Let me take you to the key business highlights for the quarter. Please note that all the financial figures mentioned are reported in their respective local currencies. Our North America generic business recorded revenue of Thank you very much. New products in the region, including complex generics such as Bosotinib and Nintetanib. And we remain on track to bring more such products to the market as we progress through the year. Our branded franchise, including India Emerging Markets and Consumer Health Business, in equity in Replaced Therapy, or NRT, together accounted for 42% of overall revenues and remain an important source of stable margins for the company. Our emerging markets business recorded revenue of ₹1,833 accounting for 22% of our overall revenues and reflecting a robust growth of 31% year-on-year and 2% quarter-on-quarter. Growth was driven by new product launches across markets and favorable currency movements. During the quarter, we introduced 43 new products across countries. Our India-based revenues were 1,788 crores rupees, accounting for 21% of our overall revenues and delivering robust double-digit Eronil growth of 17% and 10% sequentially. This performance was primarily driven by the innovation franchise new launches including acquired brands, price increase and volume growth. IQ via June 2026 data highlights a continued outperformance of the Indian pharmaceutical markets and moving quarterly total growth of 14.6% versus 13.5% for the IPM in the moving annual total MIT growth of 13.5% versus 11.1% for the market. Our IPM rank stood at 9 for the quarter and 10 for the year. We launched seven new brands during the quarter, further enhancing our domestic presence. Our European business, which includes NLP, posted revenue of $131 million for the quarter, accounting for 18% of our overall revenues. Revenues were broadly in line with the corresponding period last year and declined 3% sequentially, on account of price erosion as well as the impact of operating model. Changes for CNRT integration explained by MDN offsetting the contribution from new product launches and generics. During the quarter, we launched 24 new generics products across market, further expanding our European product portfolio. Our PSAI business reported revenues of $91 million, accounting for 11% of the overall revenues. Revenues declined 5% year-over-year and 10% sequentially. Primarily on account of lower API volume uptake during the quarter, we filed 38 drug master files globally. We remain focused on strengthening our core business while building the next wave of growth across peptides by similar consumer health and innovation. We continue to advance key products such as Imagglutide and Abatacept, improve operational efficiency, and pursue value-accreting business development opportunities to drive long-term value creation. With that, I invite your questions as we move into the Q&A session.

Thank you very much, Erez. We will now begin the question and answer session. To join the question queue, please use the red hand option available on the bar at the bottom of your Zoom application. If you wish to exit the question queue, you may click on the lower hand option. Participants are requested to not ask more than two questions at a time and rejoin the queue in case of any incremental queries. I would like to reiterate that the chat will not be monitored for any questions to the management. However, in case of any technical concerns, please do feel free to use that option. The first question is from the line of Neha Manturia from Bank of America.

Neha, please go ahead. My first question is on the EBITDA margin guidance that we had mentioned that we should be able to get to 20% EBITDA even without SEMA. Now, given how the quota is shaped up, even if I were to adjust for SEMA, I think you mentioned IT. You know, how should we think about the margin improvement from here, even assuming that, you know, there's still uncertainty about when and how much SEMA comes back?

Yeah, just a technicality is the first part of the question. If you can repeat, we heard you from the middle.

Okay, my question was that we have given a guidance of 20% margins excluding SEMA. So, you know, just wanted to get a sense of how we improve, you know, the current IT margins that you've indicated adjusted for SEMA and the Middle East impact, given that we still uncertain about, you know, when SEMA comes back and how much it comes back in the second half.

Nia, just to make sure that if we are taking out from the 12.5 and we take out the impact of what we provide Plus, and here that what we did not sell, just to make sure that in addition to PLI and the rest of the staff, what I sell the high teens, it's actually around 18%. Okay, so this quarter, the equivalent of the 19% last quarter is 18% for this quarter. We are Still, I maintain what we discussed a few weeks ago, that we are in the neighborhood of the 20% and likely to stay, and that's what we are saying we will do in the next quarter, including the quarter next quarter, which will not be with semanglutide. So that's still the case to be in the neighborhood of the 20%. As we will resume, because we with the assumption that we will come back with Simal Luthai in November. Of course, under this assumption, the margins will be higher than that. So, we are maintaining what we have discussed in June.

Understood. And the second question is on the U.S. business. There seems to be a decline quarter on quarter despite the fact that we launched Canada. We had Bocitoneb. and I'm adjusting the shelf-stop adjustment in the base quarter here. What exactly happened in the US? Because given we had the Bosset Neger CF launch, I would have assumed some channel filling as well as the Canada supplies?

I think it's actually in the right direction. There was some timing of procurement of the product. We and the launch of the product was very successful. So overall, I'm still maintaining a double digit growth for the U.S. market. Q&Q, as you saw already in this quarter, we grew double digits and it will continue throughout the year. So it's a double digit growth in the United States. It's just timing of product, nothing special.

Thank you so much.

Thank you. Thank you. The next question is from the line of Dr. Kunal Damesha from Macquarie. Kunal, go ahead please.

Hi, good evening. Thank you for the opportunity. First question on Abadacet update. So two aspects here. One on plant inspection where we have got seven observations and we have submitted the response. But let's say when we compare the observation with the last inspection which had like five observations How does those compare? And second aspect, from an ongoing dialogue perspective with the US FDA on the product approval, what are the types of query we are receiving? Is it on data on the clinical side, manufacturing related, CNC related? Color here would be helpful.

Sure. So, the observation, the seven were very different. Then those go out, and we believe that they are addressable. And we sent all the relevant information to the USFDA on Friday, which was well within the stipulated time. So this is undergone. Now we will seek a feedback, obviously, from the VDA of what we submitted. As related to the BLA, we did not receive any query as we speak. The goal date of the product is still in December and this is still intact. We did not have any query or any ask of date.

Sure, and on that, let's say inspection, what is your understanding? Would it require another inspection or the response you have submitted would suffice?

To my opinion, we should get approval.

Sure. So that's the first question. Second question is, some of the productivity measures that we have talked about in the past, that we will try to improve the efficiencies. But the way I see it, when I look at the SC&D expense without R&D, after removing R&D, Q1Q is still higher, right? So, is there any specific, you know, cost saving measures are we undertaking? If yes, what's the quantum in terms of saving that we can see and when those measures would be visible in the overall, you know, performance?

So, Kunal, if we can decide, even if We said like our absolute SJA amount like FI26, FI26 largely in line with FI26 actuals. This quarter, because whatever growth you have seen, largely that growth is on account of AdWords Forex rates movement as well as there is an elevated price cost on account of the So just to comment that we are planning to grow a double digit and we are planning to grow the associated cost

The productivity measures will be primarily that the sales that associate obviously with ISCO, S&M will grow much faster than the expenses. But as we grow in most of our 52% now for businesses branded markets, so naturally In such a case, we need S&M to grow the business and what is important, they will grow the sales much faster than the cost. In this case, we are talking about the gap of 10 to 12% because it's between the sales growth and the cost growth and that's where the productivity we are going to see.

And when should we start this difference in the growth? I assume it would be gradual, right? Eventually, or it's just linked to the revenue and not any specific cost measure?

No, it is. First of all, you already see that. And I know it's hard because of all those one-time activities or war activities, but you already see it, and as time will go by, it's obviously, we'll see it more, but the way to see it is that eventually that the margins, that the growth In emerging market, most of the S&M is in emerging market. And the growth in emerging market is right now north of 15%. And in some places more than 20%. While the cost is in a very low single digit growth. If we take out the one time activities.

And last one if I may just squeeze in. One is we have around 3000 crore of cash on the balance sheet. So what kind of opportunities are we looking at from the business development activity? And secondly on today's announcement from US President on tariffs on generics as to how we think about the overall development. I know the details are missing but what would be your initial impression of that and how would you tackle that? Thank you.

Sure. So just the first one was So first of all, we are engaged in this development. I also mentioned it in my script. There are actually quite a few deals that we are engaging in all sectors, in generics, in innovation, in biosimilars, and hopefully we can announce those deals as we sign it. So the cash and the balance sheet will be used for inorganic. On the tariff, we've been there last year. There is, obviously, it's a tweet. And between tweets and the reality, a lot of things likely to happen. As we speak, I don't see any reason to be concerned. Even according to the tweet, we are It's supposed to have two years without tariff. It's not practical to move any facility in two years. You know it well. Everybody knows it well. So I'm assuming that it's an opening for a discussion and dialogue both the IPA here in India as well as the association in the United States already engaged on that. So we will see how it evolves. Personally, I don't... At this stage, give too much weight to that.

Almost 25-30% of our revenues are actually being manufactured by CMOs in the US. So we already have that as a starting point.

I will not give too much weight at this stage for that. Let's see how it will go. We've been there last year and between what we started and how it ends, it was very, very different.

Sure, thank you and all the best. Thank you.

Thanks Kunal. The next question is from the line of Tausef Sheikh from BNP Paribas XM. Tausef, please go ahead.

Thanks Aishwarya for the opportunity. Good evening. First few questions on semaglutide pens and API. Can you tell us how many pens has Dr. Reddy able to sell during the quarter and a broad-based breakup or regional wise would be helpful?

Thank you Tausef. Yes, so we sold 190,000 pens before we stopped. We were supposed to sell more, by the way, but obviously that's also part of the reason why there is a relatively high level of provision that we have to do on material and benches that we do not use. Obviously, most of it will be for the market of Canada. We have also for India as well. We are still maintaining what I said nine days ago, that with the assumption that we will finish, and this is still the timeline, that in around the third week of September, we are supposed to finish all the testing of the ABI, and then supply to our partners one source, We have the slotting and agreement with them. And if everything will go well, we should be able to give to the market 6 to 7 million pence between November and March. That's still the same place that we are.

Yeah, that's helpful. Second question on the FEMA API. Just wanted to confirm that Dr. Reddy is also supplying this API to many global pharma manufacturers who are also your competitors in Canada and other markets. Just want to understand your strategy over here means how much percent of capacity Dr. Reddy plans to keep for captive consumption for the future?

We have plenty of capacity. The issue The theoretical capacity, I say theoretical because we need to scale up in a satisfactory manner, but we have plenty of capacity for both third parties as well as ourselves. We are talking about the theoretical can come to 550, but let's say even with the with a non-scale app that can be north of 300 as capacity. At this stage, it's not relevant. It's more about the quality of the API, not the capacity.

The last question, what would be your timeline for the launch if the product has to be approved from the CMO side? Can we expect some delay from the earlier guidance which you have planned in calendar year 2027?

Abatacept is not out of CMO. Abatacept is made by our own facility in Vajpuli. And that's the The timing is a launch upon approval. Right now the goal is December, so obviously we hope for that, but we need to see whether we will get additional query and if that will stay intact.

But I guess I think we have filed the product from two of the facets, right? The other one is from CMO's side. We have done the dual filings for the product, right?

But the safe was filed only from a passport itself.

Understood. That's helpful. We'll get back on the queue.

Thank you, Kausar. The next question is from the line of Tamayanti Kerai from HSBC. Tamayanti, please go ahead.

Hi. Thank you for the opportunity. My question is again on semaglutides. So, as you continue to work towards resuming supplies after addressing the OSS issues, we understand in some of your targeted market, new players are getting approvals, etc. So, we understand you are B2B suppliers to a few of them, but nonetheless, by the time you get back in these markets, how do you assess the competition scenario and your Your ability to gain market share there.

So we believe right now that the demand for the 6 to 7 million trains will be there for us. And it's even backed with orders. So we believe that we'll be able to sell all the 6 to 7. Obviously it's a bummer. We cannot deny it. We see the consequences. We lost the Four months of sales for this. Obviously, from the 10-11 to the 6-7, this is the impact on us. But we feel that we will stay there, that the demand for the product is still very high. And the people that will enter the market in these four months, to the best of our knowledge, there are not that many, at least in the markets, that we are planning to get approvals. So it's a bummer but we believe that the product will stay solid for us.

Okay and also wanted to understand this API issue, will it impact the review of application for semaglutide in some of the market apart from obviously Canada is something where you have approved product but say in Brazil or another market will the applications will be

No, because the specs stay the same. So we are not changing the specs or the quality. It was just our ability to meet the specs in the scalar batch of the API, which we need to resolve. But the file is good. The quality of the drug product is good. So I don't anticipate any delays or a change to applications anywhere. including Brazil.

Okay, so in how many countries you have filed a semaclotide application so far?

How many we filed already?

12-13 countries. For sure.

So the program of the 80 countries remain the same if I remember correctly but please forgive me if I'm not fully accurate it's around the 30 countries already if I remember correctly.

Sure, and my last question is, how should we look at R&D and tax rate from here on? So, we understand this quarter had some benefit on the taxes, but on a normalized basis, how should we look for the full year?

So, our tax rate around between, I think, 24 to 25% on the So yes, the health and R&D, what we have stated earlier, it is in the range of 7-8%.

Okay, and any major R&D programs after Abatacept, where you plan to spend majority?

So we have a long pipeline for the future, both on the peptides as well as additional biosimilars. This is likely to be closer to the 7%, like Amin said, but most of the R&D spent is right now going to products post-2034, between 2034 to 2040 type of, that's where the R&D goes. Besides, of course, some allocation that comes for licensing fee, as well as remediation of products, but mostly it's for later products.

Sure, thank you. I'll get back into it. Thank you, Ramanji. The next question is from the line of Shayan Mukherjee from Nobura. Shayan, please go ahead.

Thanks for taking my question. Since you last addressed on the SEMA situation, is there any progress in terms of root cause analysis and how you see possibility of a resolution? How do you assess the risk

We identified the root cause. We started also the activities in the sites. There is a program management that takes us again to around September 22nd, September 23rd. The success rate is high. I don't know to say exactly percentage. If I need to show a number, it's a Somewhere between 80-90%, but there is a chance that it will fail. I just want to make sure it's not 100%. But we feel relatively confident. Let's cross our fingers on that.

I see. Okay. And just one last one on CAPEX. What's the guidance for this year on CAPEX and for next year, please?

So, we see, I think, this year close to, at this point of time, I think around 1800 crores on the full year basis.

And will this come down next year, you think?

Hopefully, that's what is our expectations, but around that range, because, I don't know, there will be continuously for the specific product investments in the biosimilars and the prepat and then regular cathexes and Thank you. Already, if you see that earlier, we were in the 2500 to 2700 gross range and then from there, we have just this year's reducing to 1800. I believe, I think that that stays at that level.

Okay, sir. If I can just ask one question because you mentioned about Middle East conflict and freight cost, etc., What's the level of impact, either as a percentage of sale or an absolute amount, if you can quantify?

It would be both solvents and the price on the EBITDA is close to around 1%.

Okay. And is there any improvement now? Because the conflict seems to have escalated once again. So, how you see for the rest of the year?

So, we believe I think given as long as it continues, I think because earlier we thought, I don't know, suppose it's a The next question is from the line of Rahul Jivani from IIFL. Rahul, please go ahead.

Yeah, thank you, sir, for taking my question. Sir, I wanted some clarity in terms of a base business growth. Now, if I look at North America revenue base in FY22 was close to a billion dollars. And if I take this quarter's number, then we are analyzing at around 950 million dollars. Now, over these past four years, we have launched around 90 to 100 products in U.S., We did a main acquisition as well which contributed $100 million in terms of incremental revenue. So despite these launches and main acquisition, where have we struggled in terms of driving growth on the base US business? So if you can please comment on that.

No, sure. Obviously, we faced on the base of the 0.22 or any other In some of the years it was even in double digits, in some of the years it was in single digits. This is, and you know that very well, very normal for the United States. And against that we brought new products, some brought a small value. and some less. Overall, I'm reiterating what I'm saying all along, that the U.S. market, the generic piece of it, is at the best single-digit growth without the upside. And from time to time there is an upside that comes, and we had an upside through the years, whether it was linagulamide and before that there was other products. So that piece of the market is a single digit, even though single digit type of a market, in which new products compensate for price erosion. That piece, the reason that we are still there, besides that is that this group of products is what's feeding the growth in the American market as well as in Europe. So the leverage growth and what you see now in Europe as well as in energy market is primarily the U.S. portfolio that is growing there. So we moved from investing in the U.S. to take a product and launch it globally. And so overall the ROI of the product that we launch in the years that you mentioned actually give us a very, very good ROI. Just it's not coming in the United States. We see it in the other markets. In addition to that, we are obviously diversifying ourselves to other business models, as we stated. But to your analysis, you are correct in this period of time, if you take out all the Clarkina Dolomites, your analysis is correct.

Sure sir and do you think that we have lagged peers in terms of R&D productivity for the US generic business given that many of our Indian peers have been able to launch products in let's say respiratory segment or injectables which has allowed them to scale up their US portfolio. While we obviously seem to have had pretty muted performance on the US business over the past 4-5 year period. So is there any issues in terms of the productivity for R&D business and do we have any measures in terms of evaluating this R&D productivity particularly for the US general business?

So to your question, yes we failed in the certain complex generics. We even stated some of them in the past, like Avosucrose, like Contribute Estrogen, like some of the peptides that we were late. So the answer is yes, we did have these issues. I believe that we corrected it. Obviously, as we know very well, the R&D expenses of today's product that we will launch, on average, 10 to 20 years from now, So obviously the products that we launched in this period of time were products that were developed before that, and we absolutely had productivity issues, and I believe that we took the right measures to correct it. And again, I agree with your observation. I believe that we took care of it.

Sure sir, and last question from my end. On Abatacept, I was also under the impression that we would file Abatacept from the partner facility as well. But right now you are saying that Abatacept is only filed from Bachapalli. So do you see any risk to Abatacept now in terms of let's say contributing to us in FY28 and are we evaluating an alternate site filing for Abatacept?

So a bataset was never meant to be filed from a CMO. It was developed and meant to be filed out of batch pooling from our CCM5, which is our drug substance, and our FFM2, which is the fill and finish, both of them in batch pooling. So this was always the plan. There was some discussion in the past whether, because of tariff, we should get A kind of, in the case of tariff, should we get a CMO in the United States? We did engage with this issue, but tariff became not relevant, plus any CMO that we do now will have to be a post-approval supplement, because first they will have to approve the product, and then based on that they can You can add information about the CMO. So any activity like that will be a post-approval supplement and will require also relatively high cost because as you know, CMO of biologics product is not cheap. At the moment, the launch will be out of batch pulling. About the risk, there are two types of risk. One is in the case that we will have additional query on the GMP, and I believe that it's addressable, like I mentioned, but it is possible to get. And second, queries about the queries that we may get on the VLA. If we will get this, naturally can delay the launch of AvataSafe. As we speak today, The goal date for a BATASET is in mid-December 2026. Sure, sir.

That's it from my side. Thank you.

Thanks, all. The next question is from the line of Vivek Agarwal from Citi. Vivek, please go ahead.

Thank you, Surya. Thanks for the opportunity. I just want to understand the India business. You have done a In India, if we remove the residence acquisition, it's 15%? 15.5% is fully organic. Understood. And that, does that include the semaglutite supply as well? Not much of it. Thank you. Just one more question on Bursa Pranayam. Does that include a full quarter impact of launch or is that a very small launch in this matter?

It's one month. It's two weeks of supply and we have exclusivity on the 400 MG.

Understood. Thanks. That's all my side.

Thank you. The next question is from the line of Dr. Bino Patiparanpal from Alara Capital. Bino, please go ahead.

Hi, good evening. Just a couple of quick questions. One, in Canada, I believe we had an arrangement to provide semaglutide to sandals as well. Does that deal still hold and are they going to wait for our supplies to be back?

Yes, it still holds and we believe that if supply will come back in November, we'll be able to meet the commitment to Sundance.

And second on Gosuchini, I believe it's a partner product, you are selling it in the market. What would be the broad profit share arrangement? Is it equal or do you make only a distribution margin?

So, overall, if you see this margin from this product is above company average margin.

Thank you.

The next question is from the line of Suryapatra from Philip Capital, Surya, please go ahead.

Yeah, thanks for the opportunity. My first question is about the NRT. You mentioned in your opening remark that we have seen a decline this quarter. This is after the integration, complete integration of the acquisition.

So can you give some sense that okay what led to this kind of decline and whether this is a kind of a trend likely to be seen even subsequent quarters?

The trend is a trend of course. What we had this quarter is that in some markets Because of the cut of an inventory that were in the market, we did not sell in some weeks in this quarter, and that's what led to that, plus the timing of the tender in Brazil, in which we won, but we sold more in the quarter and we did not sell in this quarter. Overall you should see continuous growth and very very healthy margins. So far so good on this one.

So apart from what Erez said, another one is because there is a, till March 2026, last year we were just depending on Helion, I think they were doing, then we were paying certain fee. and this year we completed the integration by March 2020. The entire sales we are operating and then a part of this new model and then what the alien was offering earlier rebates and discounts were not impacting the sales lane but this year now seems like we are directly distributing the product to the distribute customers and then what the rebate discounts I think we are giving that is now part of the Yeah? Yeah?

Alright, thanks Surya. The next question is from the line of Shashank Krishnakumar from NK Capital. Shashank, please go ahead.

Hi, thanks for taking my question. My first one was on our Rituximab filing. I think one of our competitors has received interchangeability recently. So does our filing also include comparative data so that on approval would we also get interchangeability on this product?

Yes, so Rituximab for sure will be interchangeable. As you know, we got delayed because Rituximab approval in the United States got delayed. So for us, it's mostly to obtain approvals because the USFD inspection PI was forevoked about the Sapiritukse Mab. Once we go, our partners will not have a problem to switch products. So our products will be also interchangeable.

Thank you. That's helpful. And second one on Denosumab, I think... Obviously, our filing was stuck because of issues at our partner's facility. I believe our partner has addressed the FDS observations, but the resubmission obviously has to happen at our end. So, have we resubmitted the BLA for Denasumab?

The BLA is coming only from our partner. It is also making the products in that. And we are now in discussions. Good. Thank you. That's it from me.

Thanks, Chand.

Participants are requested to restrict the number of questions to just one to ensure that everyone on the call gets an opportunity to interact with management. The next question is from the line of Yogesh Soni, Haithong Securities. Yogesh, please go ahead.

Thanks for the opportunity.

So my question is with regard to the semaglutide API provision that you have taken. If you could help us understand, had this provision not been taken, what would have been the pen volume that would have been sold? So the question is coming to understand what is the opportunity loss that we have faced as a result of this API provision.

So, the opportunity is about 3 to 4 million 10s, assuming that we are coming back in November.

Understood. And thank you for that. And second question is, just to understand, I mean, in one and a half months of commercialization in this Canada market, what kind of market share did we enjoy in this MRU type space?

Yes, so we did not have the chance to sell much. I cannot really speak on market share. Firstly, we were one of the first to launch, along with Apotex, so naturally, by the time that we come back, we're probably going to be only the two of us. So naturally, when you are two, it's a relatively high market share, but we did not manage to get market share per se, as we did not sell much.

If I can ask one more question, so given that we are looking to resume the supplies from November, so what kind of, I mean what is the confidence of around 6 to 7 million hens, given that Apotex have already scaled up its market share in the next 3 to 4 months, so how difficult does this target seem for us?

So the confidence is high. It's not just Canada for us. By that period of time, we'll have approval in quite a few markets. Plus, we have engagement with partners. We mentioned some of the names. So the confidence is very high, actually. All of our partners are looking forward that we'll come back. So, like I mentioned before, I believe that we will have a solid demand for these 6 to 7 million pens. and also I believe that our relationship with our partners will allow to make us this product as required. We just need to give them the API.

Thank you, Erez, for your clarification.

Thank you, Erez. I will once again request everyone to just read the number of questions to just one since we have many in the question queue. The next question is Yes, can you hear me? Sorry.

Yeah, so my question is regarding the Canada market. So we have seen that a third competitor has also gotten approval recently and one of the other competitors are saying, are targeting December end approval. So with three to four peers in the market, what kind of pricing do you see in the Canada market when supply resumes for you in November?

Yeah, the partner that got approval is using our products. So... And I'm not anticipating any more prices because the price went day one to the type of market that reflects the three players and above. So I do not anticipate additional, you know, kind of pricing or reimbursement pricing. Naturally, once we come back and we'll see how many more, we may have to They change rebates or stuff like that. This is yet to be seen. But at the moment, also, the one that got approval is waiting for us to resolve the operation issues.

So, just to put it in perspective, what kind of prices do you expect then? Would it be in the range of $30? Or would it be lower than that? Could you give us the original sense on that?

As you know, and I discussed it in previous meetings, the price in Canada is 78 Canadian. And then from that you need to have the margins that you need to give to the relevant retailers. It depends on the type of market that you do, whether it is a private market, Public Market or Cash Market. So it is range from 38% which is for the retail and for what you call the private market and then in accordance depends on how many patients are also reimbursed by the relevant provinces you may need to give additional 5-6% to the relevant provinces. That's Does it not change from previous meetings in the same set of numbers?

My next question is about in the U.S. So, your new guidance board doubled as it got in the U.S. So, is it the guidance board of base business excluding semaglutide or is it just a modification of it?

Yes, Simaglutide is in Canada. So, we are not selling in the United States. So, yeah, it's without Simaglutide and without Linagivimide.

Sorry? Okay, S-Linagivimide, primarily for the imported oils. It will double digit growth.

It's a double digit growth and was already that this quarter.

Okay, thanks. The next question is from the line also with Gupta from Antique Stockbroking. Sumit, please go ahead.

Hi, thanks for the opportunity.

Sir, what are the biologic sales globally as of now and when can we expect it to break even? Sorry, again?

On the biologic sales, how much is it now?

About 2% of the overall. Okay.

It's about 2% of our sales and we are supposed to be profitable the day that we launch Abatacept. Okay.

And like how should we see Abatacept going forward over the next 2-3 years?

What will the timing do you expect? So we have submitted the ID for Abacept United States. Like I mentioned before, December is the goal date. That's the earliest we can get approval. We can launch upon approval. The Europe IV was also filed, but it's very, very small because in Europe it's primarily the sub-Q. In terms of the sub-Q, it will be in 2028, likely around March of 2028 or February. February, March 28, United States, and probably around September to October in Europe. And that's all, sir. Thank you.

Thank you very much. The next question is from the line of Vishal Manchanda from Systematics. Vishal, I would request you to speak to yourself. Just one question, please.

Hi, thanks for the opportunity. On our biologic plant inspection, can you share whether we had any observations related to sterility assurance?

No, there is not as such and like I mentioned before, all the observations are addressable and we already answered them.

And do you expect any scale-up issues in abatacept like we saw in semaglutide?

It's obviously very, very different products. I hope not. We are not planning that. But you know, in pharmaceutical, you never know. But right now, we are optimistic.

Got it. And PLI incentives, if you can call out, do we expect any meaningful number here?

So, in the first quarter of financials, no PLI.

Anything in the next nine months, meaningful?

No. So once I think semi-glutide supply resumes, I think as the PLA scheme also we should have for the set of products minimum growth. Once we assess and then if the growth is there and then PLA we start accounting.

Got it. Thank you. Okay. In the interest of time we will continue.

Okay.

I love it. The next question is from the line of Krishnendu Saha from Quantum Mutual Funds. Thank you very much.

So whatever it is, as per the agreement, suppose whatever it is, that's already taken care. And then in case of Sander Aspen, I think at this point of time, we don't expect any such case.

Okay. And just to jog my memory, the API is being supplied from a USFDA plant or which plant is it coming from?

This is from a Wysag plant C206. This is a USFDA approved plant.

So, if anything, if there is an OAI from this plant, does our approval in Canada get, is it fully backed?

Sorry, sorry, sorry. There is no OAI. No, it is allowed. If there will be an OAI, then it will affect the U.S. Maybe the Canadian will do that, but it's very hypothetical because the U.S. inspected the plant already this year and we got approval. So not relevant. But that's a hypothetical question. Canadian and American are different regimes.

Yeah, and it's from the Indian plant. Okay. And this is 40 mg which we have exclusively. How big is the market size? Just for my knowledge, please. How is the nicotine patch doing for us as of now? Any growth rate you are seeing out there?

Is it a profitable business for us?

It's a profitable and it is growing and we are very happy with it. We answered these questions before. Thank you. If we can not repeat questions, we are happy to give all our time, but please let us. Sure. Thank you. Thank you.

I just want to ask a question. Boston has about 3 million as far as the market is concerned.

Yeah. Thank you.

The next question is from the line of Rupesh Satya from Laund Equity Capital. Rupesh, please go ahead.

Yeah, hi, am I audible?

Yes.

Yeah, my question is on interchangeability in Canadian markets. So there are these various provinces which gives out... Interchangeability designation and also I think private insurers also give interchangeability designation and most of this insurance has a clause of mandatory generic substitution. So could you give color that what does it take to get this interchangeability designation and when that happens my expectation is all of the So there is no problem with interchangeability in any market. The product is approved as generics.

and the type of the API doesn't affect it. So the semaglutide is approved as a generic product. No issues of interchangeability and you don't need to prove anything beyond what the normal submissions. We had to show obviously comparability as well as all the relevant safety like immunogenicity and other data.

So next year then, Janrik will have 80-90% market share in Canada. Is that a fair thing to assume?

I don't know about that. It's about also the confidence of the people. At least at the launch time, the allocation of the retailers assumes 60% and then will grow.

Insurance driven markets. Pardon for interruption. Insurance driven markets. I'm not asking about out-of-pocket or retail markets.

I'm trying to answer there. It started with 60% and likely to go higher. What exactly the number will be, I don't know, but I believe that as the confidence and the supply will be there, it's going to be primarily generic market, yes.

Okay, and then just quickly, when do we expect Brazil approval for us or any of our partners? Any time estimate you can give?

It should be shortly. All this stuff about the rejection was reversed and we are expecting approval in the next few weeks. Okay. Thank you. Thank you for answering my questions.

In this time, we'll take one last question from Shahin Mukherjee. I think he's joined back with you.

Yeah, thanks for taking the follow-up. Just one question, a couple of questions. So, in the U.S., I think you mentioned 20-25 launches. How many we are expecting through the rest of the year? And are there any material launches that are lined up or you expect?

So altogether right now we are targeting 27. And at least we are supposed to have a reasonable launch, let's call it. I cannot share the name of the product. Already in the next couple of weeks. So in the second quarter.

And how large is the opportunity? Can you give an idea about the size or the revenue potential from that launch?

It should be in the range of tens of millions of dollars, that specific launch.

Okay, thank you. And MVN, if you can talk about, like, I understand biologics and peptide facility operations are not generating enough, any revenues at this point. What's the revenue cost mismatch there? What's the cost that is hitting the P&L on account of this, which is not generating any revenues?

So, in the biologics like a already we invested for like a CCM5 for a motor set certainly. So, we are just waiting for approval and then whatever is the expenses is already sitting in our P&L. Similarly, what the capacities we have created for web test both for API and formulation of field finish also, it is there. Once these two products comes back and definitely again it will give the profit positive.

Yeah, but you know, I was wondering if you can quantify the amount of cost that you are incurring on account of these two at this point.

Maybe I'll just come back.

Okay. Thank you.

That was the last question. Thanks, Shain. Thank you everyone for joining us today. We value your time and your participation on this call. If you have any further questions or need any additional information, please do feel free to reach out to me. With that, we conclude today's Thank you. Thank you very much. Thank you.