Aishwarya Sitharam: Joining us today are Erez Israeli and M. V. Narasimham. 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. Reconciliation 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.
Aishwarya Sitharam: 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 transcript will be made available on our website shortly. Please note that this call is the proprietary material of Dr. Reddy's Laboratories Limited and may not be rebroadcast or quoted in any media or public forum without prior written consent from the company. With that, let me hand the call over to MVN to present the financial highlights for the quarter. Over to you, MVN.
M. V. Narasimham: 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 FY 2027. The business reported revenue decline of 5.6% and EBITDA margin of 12.5% for the quarter, reflecting the impact of lower lenalidomide revenues, which contributed to the corresponding period last year, as well as a provision of INR 240 crores for inventory and other costs associated with the recent semaglutide API-related challenges. Notably, the underlying base business, excluding lenalidomide, continued 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 U.S. dollars using a convenience translation rate of INR 94.66, the exchange rate prevailing as of June 30th, 2026.
M. V. Narasimham: Consolidated revenue stood at INR 8,071 crores, which is $853 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 lenalidomide sales. NRT 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, Haleon. This change in operating model is profit neutral. Consolidated gross profit margin was at 46.5%, a decrease of 1,039 basis points year-over-year, and an increase of 169 basis points sequentially. The decline in margins during the quarter was largely on account of lower lenalidomide sales, the semaglutide API-related provision mentioned earlier, as well as higher solvent costs on account of Middle East conflict.
M. V. Narasimham: The reported gross margin was 51.6% for Global Generics and 4.5% for PSAI. Excluding the semaglutide API-related provision mentioned earlier, the overall margin was 49.4%, while that for Global Generics was 53.8%, and for PSAI was at 12.9%. The SG&A spends was at INR 2,082 crores, an increase of 12% and 4% sequentially, accounting for 36% of revenues. The year-over-year increase was primarily driven by higher personnel costs due to annual increments, adverse Forex 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 INR 577 crores, a decline 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.
M. V. Narasimham: The underlying EBITDA, including other income, stood at INR 1,009 crores for the quarter, which is $107 million, a decrease of 1,416 basis points year-over-year and 55 basis points sequentially, reflecting a margin of 12.5% of the revenues. Excluding the semaglutide API-related provision, the margin was at 15.4%. As a result, the profit before tax was INR 553 crores, that is $58 million, representing a margin of 6.8%. Excluding the semaglutide API-related provision, 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 consequent to the favorable resolution of the tax assessment pertaining to earlier year and favorable jurisdictional mix for the quarter in comparison to the same period in the previous year.
M. V. Narasimham: Profit after tax attributable to equity holders of the parent for the quarter stood at INR 443 crores, which is $47 million, a margin of 5% on the revenues before adjusting for the semaglutide API-related provision mentioned earlier. Diluted EPS for the quarter is INR 5.32. Operating working capital as of 30th June 2026 was INR 14,353 crores, which is $1.52 billion, a decrease of INR 81 crores over 31st March 2026. CapEx cash outflow for the quarter stood at INR 307 crores, which is $32 million. Cash flow during the quarter before acquisition-related payout was negative INR 216 crores, which is negative of $23 million. As of June 30th, 2026, we have a net cash surplus of INR 3,057 crores, which is $323 million.
M. V. Narasimham: Foreign currency cash flow hedges executed through derivative instruments during the period are as follows: $354 million hedged using a combination of forwards and risk-reversal options scheduled to mature by March 2027. These contracts are hedged at the rate of INR 92.34 to INR 94.63 per U.S. dollar. RUB 2.8 billion hedged 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.
Erez Israeli: Thank you, MVN, and good day to all of you. We appreciate you joining us today. Thank you for your continued interest in our company. We remain consistent in our strategic priorities and committed to delivering growth and profitability through disciplined execution. As the operating environment continues to evolve, we are focused on strengthening our base business and building future growth engines in peptides, biosimilars, consumer health, and innovation while pursuing targeted business development initiatives to augment our organic growth efforts. The underlying base business delivered healthy double-digit growth across all key geographies, including North America. The quarter's EBITDA margins were adversely impacted by semaglutide-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.
Erez Israeli: We are working towards resolving the issue and are planning to resume semaglutide commercial supplies 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 semaglutide supplies. The strength of our base business and our ongoing productivity initiatives will continue to support double-digit base business growth and steady margin improvement. Let me now walk you through some of the key highlights of the quarter. We commercialized a few key complex generic products, including the anticancer drug bosutinib, a first-to-market launch with the 180 days of generic drug exclusivity for the 400-milligram strengths, and nintedanib used in the treatment of lung disease in the U.S.
Erez Israeli: In Canada, we are the first company to secure approval for the launch of semaglutide for the treatment of type 2 diabetes. We launched oral semaglutide in India and remain committed to building this important metabolic franchise complemented by nutrition offerings such as Celevida GLP+ through our collaboration with Nestlé. We continue to make progress bringing innovation to patients in underserved markets through partnership. Our in-licensed novel therapy toripalimab for the treatment of nasopharyngeal carcinoma has entered the INR 100 crore club in less than two years of launch in India. During the quarter, we partnered with Innoviva Specialty Therapeutics to develop and commercialize XACDURO used in the treatment of hospital-acquired bacterial pneumonia in selected markets across South and Central America, the Caribbean, Russia, and CIS countries.
Erez Israeli: Through our collaboration with GARDP and our subsidiary Aurigene Pharmaceutical Services, we achieved an important milestone in our access agenda by securing Thai FDA approval for zoliflodacin, a first-in-class treatment for uncomplicated gonorrhea. The approval came just six months after the U.S. FDA approval, making Thailand the first LMIC country to approve the product. On the regulatory front, the U.S. FDA completed a pre-license inspection, PLI, at our biologics manufacturing facility in Bachupally, Hyderabad in June 2026 and issued a Form 483 with seven observations, which we already responded well within the stipulated timelines. Our commitment to good governance and sustainability continues to be recognized globally.
Erez Israeli: During the quarter, we celebrated 25 years of our New York Stock Exchange listing, reinforcing our distinction as the first and only Indian pharmaceutical company listed at the exchange, as well as our commitment to global best practice in governance, compliance, and capital market access. FTSE Russell placed us as a top 1% worldwide, while Time/Statista ranked us 165th globally and fifth among Indian companies among the world's most sustainable companies. Let me take you through 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 reported revenue of $236 million for the quarter, accounting for 27% of our overall revenue and reflecting a decline of 41% year-over-year and a growth of 19% sequentially. The year-over-year decline was primarily on account of lower revenue from lenalidomide.
Erez Israeli: The underlying base business delivered double-digit growth aided by new product launches during the quarter. During the quarter, we launched six new products in the region, including complex generics such as bosutinib and nintedanib, 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 nicotine replacement therapy, or NRT, together accounted for 42% of our overall revenues and remain an important source of stable margins for the company. Our emerging markets business recorded revenue of INR 1,833 crore, accounting for 22% of our overall revenues and reflecting a robust growth of 31% year-over-year and 2% quarter-on-quarter. Growth was driven by new product launches across markets and favorable currency movement. During the quarter, we introduced 43 new products across countries.
Erez Israeli: Our India-based revenues were INR 1,780 crore, accounting for 21% of our overall revenues and delivering robust double-digit year-over-year growth of 17% and 10% sequentially. This performance was primarily driven by the innovation franchise new launches, including acquired brands, price increases, and volume growth. IQVIA June 2026 data highlights our continued outperformance of the Indian pharmaceutical markets and moving quarterly total growth of 14.6% versus 13.5% for the IPM and Moving Annual Total growth of 13.5% versus 11.1% for the market. Our IPM rank stood at nine 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 NRT, posted revenue of EUR 131 million for the quarter, accounting for 18% of our overall revenues.
Erez Israeli: 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 post NRT integration explained by MVN offsetting the contribution from new product launches in the generics. During the quarter, we launched 24 new generics products across markets, 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, biosimilars, consumer health, and innovation.
Erez Israeli: We'll continue to advance key products such as semaglutide and abatacept, improve operational efficiency, and pursue value-accretive business development opportunities to drive long-term value creation. With that, I invite your questions as we move into the Q&A session.
Question-and-Answer Session
Aishwarya Sitharam: Thank you very much, Erez. We will now begin the question and answer session. To join the question queue, please use the raise 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 Manpuria from Bank of America. Neha, please go ahead.
Neha Manpuria: Yeah. I guess 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. Given how the quarter shaped up, even if I were to adjust for sema, Middle East, I think you mentioned high teens. How should we think about the margin improvement from here, even assuming that there's still uncertainty about when and how much sema comes back?
Erez Israeli: Yeah, just the technicality is the first part of the question, if you can repeat. We heard you from the middle.
Neha Manpuria: My question was that we had given a guidance of 20% margins excluding sema. Just wanted to get a sense of how we improve the current high teens margin that you've indicated, adjusted for sema and the Middle East impact, given that we're still uncertain about when sema comes back and how much it comes back.
Neha Manpuria: in the second half.
Erez Israeli: Neha, 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 costs, what I say the high teens, it's actually around 18%. Okay. This quarter, the equivalent of the 19% last quarter, it's 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 next quarter, which will not be with semaglutide. That's still the case to be in the neighborhood of the 20%.
Erez Israeli: As we will resume, because with the assumption that we will come back with semaglutide in November, of course, under this assumption, the margins will be higher than that. We are maintaining what we have discussed in June.
Neha Manpuria: Understood. 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 bosutinib. I'm adjusting the shelf stock adjustment in the base quarter here. What exactly happened in the U.S.? Because given we had the bosutinib FTF launch, I would assume some channel spending as well as the Canada supplies.
Erez Israeli: Nothing happened. It's actually in the right direction. There were some timing of-
Aishwarya Sitharam: Orders
Erez Israeli: Of procurement of the product, the launch of the product was very successful. Overall, I'm still maintaining a double-digit growth for the U.S. market. quarter-on-quarter, as you saw already in this quarter, we grew double-digit, and it will continue throughout the year. It's a double-digit growth in the United States. It's just timing of product, nothing special.
Neha Manpuria: Okay. Thank you so much.
Aishwarya Sitharam: Thanks, Neha. The next question is from the line of Dr. Kunal Dhamesha from Macquarie. Kunal, go ahead, please.
Kunal Dhamesha: Hi. Good evening. Thank you for the opportunity. First question on abatacept update. Two aspects here. One on plant inspection, where we have got seven observations and we have submitted the response. Let's say when we compare the observations with the last inspection, which had five observations, how does those compare? Second aspect, from an ongoing dialogue perspective with the U.S. FDA on the product approval, what are the types of query we are receiving? Is it on data on the clinical side, manufacturing related, CMC related? Color here would be helpful.
Erez Israeli: Sure. The observation, the seven were very different than those got, we believe they are addressable, we sent all the relevant information to the U.S. FDA on Friday, which was well within the stipulated time. This is under review, now we will seek feedback, obviously, from the FDA 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, this is still intact. We did not have any query or any ask as of date.
Kunal Dhamesha: Sure. On that, let's say inspection, what is your understanding? Would it require another inspection or the response you have submitted would suffice?
Erez Israeli: In my opinion, we should get approval.
Kunal Dhamesha: Sure. That's the first question. Second question is, some of the productivity measures that we have talked about in the past, right? That we will try to improve the efficiencies. The way I see it, when I look at the SG&A expense without R&D, after removing R&D, Q1 quarter-on-quarter is still higher, right? Is there any specific 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 performance?
M. V. Narasimham: Kunal, on this side, we said our absolute amount is largely in line with FY 2026 actuals. This quarter, whatever growth you have seen is largely on account of adverse Forex rates movement, as well as elevated freight cost on account of the Middle East conflict. Almost 75%-80% of the growth you have seen either quarter-on-quarter or year-over-year is on account of these two factors.
Erez Israeli: And to-
M. V. Narasimham: Otherwise, absolute amount is almost like if you take it out, there is not a much significant increase.
Erez Israeli: Just to Kunal, to you, that we are planning to grow double-digit, and we are planning to grow the associated cost-
M. V. Narasimham: Yes
Erez Israeli: by a low single-digit. The productivity measures will be primarily that the sales associated, obviously, with this S&M-
Erez Israeli: will grow much faster than the expenses. As 52% of our business is branded markets, naturally, in such a case, we need S&M to grow the business. What is important, we will grow the sales much faster than the cost. In this case, we are talking about the gap of 10%-12% between the sales growth and the cost growth, and that is where we are going to see the productivity.
Kunal Dhamesha: When should we start this difference in the growth? I assume it would be gradual, right, eventually? It's just linked to the revenue and not any specific cost measure?
Erez Israeli: No, it is. First of all, you already see that.
Erez Israeli: I know it is hard because of all those one-time activities and war-related activities, but you already see it. As time goes by, obviously, we will see it more, but the way to see it is that most of the S&M is in emerging market. The growth in emerging market is right now north of 15%, and in some places more than 20%, while the cost is in very low single-digit growth.
Kunal Dhamesha: Sure.
Erez Israeli: If we take out the one-time activities.
Kunal Dhamesha: Sure. Last one, if I may just squeeze in. We have around INR 3,000 crore of cash on the balance sheet. Right? What kind of opportunities are we looking at from the business development activity? Secondly, on today's announcement from U.S. 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.
Erez Israeli: Sure. Just the first one was? The tariff was the second.
Aishwarya Sitharam: 3,000.
Erez Israeli: The INR 3,000 crore.
Kunal Dhamesha: Cash.
Erez Israeli: The cash. First of all, we are engaged in business 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 them. The cash and the balance sheet will be used for inorganic. On the tariff, we have been there last year. Obviously, it is a tweet; between the tweet and reality, a lot of things are likely to happen. As we speak, I do not see any reason to be concerned, even according to the tweet, we are supposed to have two years without tariff. It is not practical to move any facility in two years. You know it well. Everybody knows it well. I am assuming that it is an opening for a discussion and dialogue.
Erez Israeli: Both the IPA here in India as well as the association in the U.S. already engaged on that. We will see as it evolves. Personally, I don't at this stage give too much weight to that.
Aishwarya Sitharam: If I may add, almost 25%-30% of our revenues are actually being manufactured by CMOs in the U.S. We already have that as a starting point.
Erez Israeli: Yeah. I will not give too much weight at this stage for that. Let's see how it will evolve. We've been there last year, between what we started and how it ended, it was very different.
Kunal Dhamesha: Sure. Thank you, all the best.
Erez Israeli: Thank you.
Aishwarya Sitharam: Thanks, Kunal. The next question is from the line of Tauseef Shaikh from BNP Paribas Exane. Tauseef, please go ahead.
Tauseef Shaikh: Thanks, Aishwarya, for the opportunity. Good evening. First few questions on semaglutide pens and API. Can you tell us how many pens Dr. Reddy's was able to sell during the quarter? A broad-based breakup region-wise would be helpful.
Erez Israeli: Yes, we sold 180,000 pens before we stopped. We were supposed to sell more, by the way. Obviously, that's also part of the reason why there is relatively high level of provision that we have to do on material and batches that we'll 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 assumption that we will finish, and this is still the timeline, that around the third week of September, we are supposed to finish all the testing of the API, then supply to our partners. We have the slotting and agreement with them, if everything goes well, we should be able to give to the market 6-7 million pens between November and March.
Erez Israeli: That's still the same place that we are.
Tauseef Shaikh: Yeah, that's helpful. Second question on the semaglutide API. Just wanted to confirm that Dr. Reddy's 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 what percentage of capacity Dr. Reddy's plans to keep for captive consumption for the future.
Erez Israeli: No, we have plenty of capacity. The theoretical capacity, I'm saying theoretical because we need to scale-up in a satisfactory manner. We have plenty of capacity for both third-party as well as ourselves. We are talking about the theoretical can go up to 550, but let's say even with the non-scale-up, it 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.
Tauseef Shaikh: That's helpful. The last question, abatacept. 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 we have planned in calendar year 2027?
Erez Israeli: abatacept is not out of CMO. abatacept is made by our own facility in Bachupally, and that's the facility that underwent the FDA inspections. The timing is a launch upon approval. Right now the goal date 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.
Tauseef Shaikh: I guess, I think we have filed the product from two of the facilities, right? The other one is from CMO side. We have done the dual filings for the product, right?
Erez Israeli: abatacept was filed only from our Bachupally site.
Tauseef Shaikh: Understood. That's helpful. I'll get back in the queue.
Aishwarya Sitharam: Thank you, Tauseef. The next question is from the line of Damayanti Kerai from HSBC. Damayanti, please go ahead.
Damayanti Kerai: Hi, thank you for the opportunity. My question is again on semaglutide. As you continue to work towards resuming supplies after addressing the OOS issues, we understand in some of your targeted market, new players are getting approvals, et cetera. We understand you are B2B supplier to a few of them, but nonetheless, by the time you get back in these market, how do you assess the competition scenario and your ability to gain market share there?
Erez Israeli: We believe right now that the demand for the six to seven million pens will be there for us, and it's even backed with orders, we believe that we'll be able to sell all the six to seven. Obviously, it's a bummer. We cannot deny it. We see the consequence. We lost the four months of sales for that. Obviously from the 10, 11 to the six, seven, 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. It's a bummer, but we believe that the product will stay solid for us.
Damayanti Kerai: Okay. 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 in other market, will the applications be halted till the time you resolve the API issue?
Erez Israeli: Because the specs stay the same. We are not changing the specs or the quality. It was just our ability to meet the specs in the scale of batch on the API, which we need to resolve. The file is good, and the quality of the drug product is good, I don't anticipate any delays or a change to our applications anywhere, including Brazil.
Damayanti Kerai: Okay. In how many countries you have filed semaglutide application so far?
Erez Israeli: How many we filed already?
Aishwarya Sitharam: More than 20, 30 countries.
Erez Israeli: For sure. 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 30 countries already, if I remember correctly.
Damayanti Kerai: Sure. My last question is, how should we look at R&D and tax rate from here on? We understand this quarter had some benefit on the taxes. On a normalized basis, how should we look for the full year?
M. V. Narasimham: Our tax rate is around 24%-25% on the full year basis. R&D, what we have stated earlier, it is in the range of 7%-8%.
Damayanti Kerai: Okay. Any major R&D programs after abatacept, where you plan to spend majority?
Erez Israeli: We have a long pipeline for the future, both on the peptides as well as additional biosimilars. This year likely we'll be closer to the 7%, like MVN said, most of the R&D spend is right now going to products post 2034. Between 2034 to 2040. That's where the R&D goes. Of course, some allocation comes for licensing fee, as well as remediation of product. Mostly it's for later product.
Damayanti Kerai: Sure. Thank you. I'll get back in touch.
Aishwarya Sitharam: Thank you, Damayanti. The next question is from the line of Saion Mukherjee from Nomura. Saion, please go ahead.
Saion Mukherjee: 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 of that program at this stage?
Erez Israeli: 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 2026. The success rate is high. I don't know the exact percentage. If I need to throw a number, it's 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.
Saion Mukherjee: I see. Okay. Just one last one on CapEx. What's the guidance for this year on CapEx and for next year, please?
M. V. Narasimham: We see, I think this year close to, at this point of time, I think around INR 1,800 crores on the full year basis.
Saion Mukherjee: Will this come down next year, you think?
M. V. Narasimham: Hopefully, that's what is our expectations, around that range, because I don't know, there is a continuously for the specific product investments in the biosimilars and the peptides and then regular CapEx as planned.
Saion Mukherjee: Thank you, sir.
M. V. Narasimham: Already if you see that earlier, we were in that INR 2,500 crore to INR 2,700 crore range, and then from there, we have just, this year is reducing to INR 1,800 crore. I believe, I think that stays at that level.
Saion Mukherjee: Okay, sir, if I can just ask one question, because you mentioned about Middle East conflict and freight cost, et cetera. What's the level of impact, either as a % of sale or in absolute amount, if you can quantify?
M. V. Narasimham: It would be both solvents and the freight on the EBITDA is close to around 1%.
Saion Mukherjee: Okay. Is there any improvement now? Because the conflict seem to have escalated once again. How you see for the rest of the year?
M. V. Narasimham: We believe, I think even as long as it continues, because earlier we thought, I don't know, suppose it stopped, then it is all the solvent prices and we have seen the decline. Now because of, once again, the war is going on, we believe, I think this will stay at least up to December, this level of increase.
Saion Mukherjee: I see. Okay. Thank you.
Aishwarya Sitharam: Thanks, Saion. The next question is from the line of Rahul Jeewani from IIFL. Rahul, please go ahead.
Rahul Jeewani: Yeah. Thank you, sir, for taking my question. Sir, I wanted some clarity in terms of our base business growth. If I look at our North America revenue base in FY 2022 was close to INR 1 billion. If I take this quarter's number, then we are annualizing at around INR 950 million. Over these past four years, we have launched around 90-100 products in U.S. We did a main acquisition as well, which contributed INR 100 million in terms of incremental revenue. Despite these launches and main acquisition, where have we struggled in terms of driving growth on the base U.S. business? If you can please comment on that.
Erez Israeli: No, sure. Obviously, we faced, on the base of FY 2022 or any other year that you are referring to, significant price erosion through this period of time. In some of the years it was even in double-digit. In some of them it was in single-digit. You know that very well, very normal for the United States. Against that, we brought new products, some brought a small value and some less. Overall, I am reiterating what I am saying all along, that the U.S. market, the generics piece of it, is at best single-digit growth without the upside. From time to time, there is an upside that comes, and we had upside through the years, whether it is by lenalidomide, and before that there were other products.
Erez Israeli: That piece of the market is a single-digit, even low single-digit type of a market, in which new products compensate for price erosion. The reason that we are still there besides that is that this group of products is what is feeding the growth in emerging market as well as in Europe. The leverage growth and what you see now in Europe as well as in emerging market is primarily the U.S. portfolio that is growing there. We moved from investing in the U.S. to take a product and launch it globally. Overall, the ROI of the product that we launched in the years that you mentioned actually gives us a very, very good ROI. It is just not coming in the United States. We see it in the other markets.
Erez Israeli: In addition to that, we're obviously diversifying ourselves to other business model, as we stated. To your analysis, you are correct. In this period of time, if you take out product like lenalidomide, your analysis is correct.
Rahul Jeewani: Sure, sir. Do you think that we have lagged peers in terms of R&D productivity for the U.S. 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 U.S. portfolio, while we obviously seem to have had a pretty muted performance on the U.S. business over the past four- to five-year period. 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 U.S. generic business?
Erez Israeli: To your question, yes, we failed in certain complex generics. We even stated some of them in the past, like iron sucrose, like conjugated estrogen, like some of the peptides that we relate. 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 12 years from now. Obviously the products that we launch 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. Again, I agree with your observation. I believe that we took care of it.
Rahul Jeewani: Sure, sir. Last question from my end. On abatacept, I was also under the impression that we would file abatacept from the partner facility as well. Right now you're saying that abatacept is only filed from Bachupally. Do you see any risk to abatacept now in terms of, let's say, contributing to us in FY 2028, and are we evaluating an alternate site filing for abatacept?
Erez Israeli: Abatacept was never meant to be filed from a CMO. It was developed and meant to be filed out of Bachupally from our CCM5, which is our drug substance, and our FFM2, which is the fill and finish, both of them in Bachupally. That was always the plan. There was some discussion in the past whether because of tariff, in the case of tariff, should we get a CMO in the U.S.? We did engage with this issue, but tariff became not relevant, plus any CMO that we do now will have to be post-approval supplement, because first they will have to approve the product, and then, based on that, you can add information about the CMO.
Erez Israeli: 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 Bachupally. 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 is addressable, like I mentioned, but it is possible to get. Second query is about the queries that we may get on the BLA. If we get this, naturally it can delay the launch of abatacept. As we speak today, the goal date for abatacept is in mid-December 2026.
Rahul Jeewani: Sure, sir. That's it from my side. Thank you.
Aishwarya Sitharam: Thanks, Rahul. The next question is from the line of Vivek Agarwal from Citi. Vivek, please go ahead.
Vivek Agarwal: Thanks, Aishwarya. Thanks for the opportunity. Just want to understand with the India business, we have done a good growth in the quarter. Just want to understand what is the organic growth if we remove a couple of small acquisitions that we have made in this quarter? Thank you.
M. V. Narasimham: Go ahead.
Erez Israeli: In India, if we remove the recent acquisition, it's 15%?
M. V. Narasimham: 15.5.
Erez Israeli: 15.5% fully organic.
Vivek Agarwal: Understood. Does that include semaglutide supply as well?
M. V. Narasimham: Not much, Vivek.
Vivek Agarwal: Understood. Thank you. Just one more question on bosutinib. Does that include a full quarter impact of launch or it's just a very small launch in this quarter?
M. V. Narasimham: It's one month. Less than a month, actually.
Erez Israeli: Less than a month.
M. V. Narasimham: Two weeks.
Erez Israeli: It's two weeks of supply and we have exclusivity on the 400 mg.
Vivek Agarwal: Understood. Thanks. That's from my side. Thank you.
Aishwarya Sitharam: Thank you. Thanks, Vivek. The next question is from the line of Dr. Bino Pathiparampil from Elara Capital. Bino, please go ahead.
Bino Pathiparampil: Hi. Good evening. Just a couple of quick questions. One, in Canada, I believe we had an arrangement to provide semaglutide to Sandoz as well. Does that deal still hold, and are they going to wait for our supplies to be back?
Erez Israeli: Yeah, it still holds, and we believe that if supply will come back in November, we'll be able to meet the commitment to Sandoz.
Bino Pathiparampil: Got it. Second, on bosutinib, 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?
M. V. Narasimham: Overall, if you see this margin from this product is above company average margin.
Bino Pathiparampil: Got it. Thank you.
Aishwarya Sitharam: Thanks, Bino. The next question is from the line of Surya Patra from PhillipCapital. Surya, please go ahead.
Surya Patra: Thanks for the opportunity. My first question is about the NRT. You mentioned in your opening remarks that we have seen a decline this quarter. This is after the complete integration of the acquisition. 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?
Erez Israeli: No, the trend is a trend of growth. What we had this quarter is that in some markets, because of the cutoff in 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 continual growth and very healthy margins. So far so good on this one.
M. V. Narasimham: Apart from what Erez said, Surya, another one is because until March 2026 last year, I think we were just depending on Haleon, and then we were paying certain fee. This year we completed the integration by March 2026. The entire sales we are operating. As part of this new model, what Haleon was offering earlier, rebates and discounts, were not impacting the sales line. This year now, since we are directly distributing the product to the distributor customers, the rebate discounts we are giving are now part of the gross to net in the revenue line. Correspondingly, there is a reduction. Overall, if you look at the profit, it is neutral.
Aishwarya Sitharam: Absolutely, there is no impact on overall profitability of this business. EBITDA margin is very healthy, and the business momentum is continuing in the very right direction. All right, thanks. Thanks, Surya. The next question is from the line of Shashank Krishnakumar from Emkay Global. Shashank, please go ahead.
Shashank Krishnakumar: Hi. Thanks for taking my question. Erez, my first one was on our rituximab filing. I think one of our competitors has received interchangeability recently. Does our filing also include comparative data, so that on approval, would we also get interchangeability on this product?
M. V. Narasimham: Rituximab.
Erez Israeli: Yeah. Our rituximab for sure will be interchangeable. As you know, we got delays because rituximab approval in the United States got delayed. For us, it's mostly to obtain approvals because the U.S. FDA inspection PI was for both abatacept rituximab. Once we go, our partners will not have a problem to switch product. Our products will be also interchangeable.
Shashank Krishnakumar: Got it. Thank you. That's helpful. 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 FDA's observations, the resubmission obviously has to happen at our end. Have we resubmitted the BLA for denosumab?
Erez Israeli: The BLA is coming only from our partner. He's also making the product in that, we are now in discussions with the partner of what to do with this product.
Shashank Krishnakumar: Got it. Thank you. That's it from my side.
Aishwarya Sitharam: Thanks, Shashank. 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, Haitong Securities. Yogesh, please go ahead.
Yogesh Soni: Thanks for the opportunity. My question is, with regards 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? The question is coming to understand what is the opportunity lost that we have faced as a result of this API provision.
Erez Israeli: The opportunity is about 3 million-4 million pens, assuming that we are coming back in November.
Yogesh Soni: Understood. Thank you for that. Second question is just to understand, in one and a half months of commercialization in this Canada market, what kind of market share did we enjoy in the semaglutide space?
Erez Israeli: Yeah, we did not have the chance to sell much. I cannot really speak on market share. Obviously, we were one of the first to launch, along with Apotex. Naturally, by the time that we'll come back, we'll probably not going to be only the two of us. 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.
Yogesh Soni: If I can squeeze in one more question. Given that we are looking to resume the supplies from November, what gives us the confidence of doing around six to seven million pens, given that Apotex would have already scaled up its market share in the next three to four months? How difficult does this target seem to us?
Erez Israeli: 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. The confidence is very high, actually. All of our partners are looking forward that we'll come back. Like I mentioned before, I believe that we will have a solid demand for these six to seven 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.
Yogesh Soni: Thank you, Erez, for your clarifications.
Aishwarya Sitharam: Thanks, Yogesh. I would once again request everyone to restrict the number of questions to just one, since we have many in the question queue. The next question is from the line of Aman Jotigas from J.P. Morgan. Aman, please go ahead.
Aman Jotigas: Yeah, can you hear me? Sorry.
Aishwarya Sitharam: Yes.
Aman Jotigas: My question is regarding the Canada market. 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. 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?
Erez Israeli: Yeah, the partner that got approval is using our product. I'm not anticipating any more prices because the price went, day 1, to the type of market that reflect the three players and above. I do not anticipate additional pricing to, or reimbursement pricing. Naturally, once we'll come back and we'll see how many more, we may have to change rebates or stuff like that. This is yet to be seen. At the moment, also, the one that got approval is waiting for us to resolve the operation issues.
Aman Jotigas: Just to put a perspective, what kind of prices do you expect then? Would it be in the range of INR 30, say, or it will be lower than that? Could you just give us a directional sense on that?
Erez Israeli: As you know, and I discussed it in previous meeting, the price in Canada is CAD 78. Then from that, you need to have the margins that you need to give to the relevant retailers, depends on the type of market that you do, whether it is a private market, public market, or cash market. It is range from 38%, which is for the retail and for what you call the private market. 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 products. This did not change from our previous meetings. It's the same set of numbers.
Aman Jotigas: Okay. Thank you. My next question-
Erez Israeli: Sure
Aman Jotigas: is on the U.S. Your guidance for double-digit growth in the U.S., so is it the guidance for the base business excluding semaglutide? Or just wanted a clarification on that.
Erez Israeli: Yes, semaglutide is in Canada, and so we are not selling in the United States. Yeah, it's without semaglutide and without lenalidomide.
Aman Jotigas: Is primarily for the U.S. though?
Erez Israeli: Sorry?
Aman Jotigas: Okay, ex lenalidomide, which is primarily for the U.S., it will be double-digit growth.
Erez Israeli: It's a double-digit growth and was already that this quarter. Yeah.
Aman Jotigas: Okay, thanks.
Aishwarya Sitharam: Thanks, Aman. The next question is from the line of Sumit Gupta from Antique Stock Broking. Sumit, please go ahead.
Sumit Gupta: Hey. Hi, thanks for the opportunity. Sir, what are the biologic sales globally as of now, and when can we expect it to break even?
Erez Israeli: Sorry, again?
Aishwarya Sitharam: Biologics.
Sumit Gupta: On the biologic sales, how much is it now?
Aishwarya Sitharam: It's about 2%. It's about 2% of the overall.
Erez Israeli: It's about 2% of our sales, and we are supposed to be profitable the day that we launch abatacept.
Sumit Gupta: Okay. How should we see abatacept going forward, let's say over the next 2-3 years? What will the timeline do you expect?
Erez Israeli: We submitted the IV products in U.S. Like I mentioned before, December is the goal date. That is the earliest we can get approval. We can launch upon approval.
M. V. Narasimham: Europe IV also we filed.
Erez Israeli: The Europe IV was also filed, but it's very small because in Europe it's primarily the subcu. In terms of the subcu, it will be in 2028, likely around March of 2028 or February or March 2028 U.S., and probably around September to October in Europe.
Sumit Gupta: Understood, sir. Thank you.
Aishwarya Sitharam: Thanks, Sumit. The next question is from the line of Vishal Manchanda from Systematix. Vishal, I would request you to restrict yourself to just one question, please.
Vishal Manchanda: Yeah. Hi, thanks for the opportunity. On our biologic plant inspection, can you share whether we had any observations related to sterility assurance?
Erez Israeli: No, there is none as such, like I mentioned before, all the observations are addressable and we already answered them.
Vishal Manchanda: Do you expect any scale-up issues in abatacept, like we saw in semaglutide?
Erez Israeli: It's obviously a very different product. I hope not. We are not planning that. In pharmaceutical, you never know. Right now, we are optimistic.
Vishal Manchanda: Got it. PLI incentives, if you can call out, do we expect any meaningful number here?
M. V. Narasimham: In the first quarter financials, no PLI.
Vishal Manchanda: Yeah. Anything in the next nine months meaningful?
M. V. Narasimham: Once, I think, semaglutide supply resumes, I think as per PLI scheme also, we should have, for the set of products, minimum growth. Once we assess and then if the growth is there, and then PLI, we will start accounting.
Vishal Manchanda: Got it. Thank you.
Aishwarya Sitharam: All right. I think in the interest of time, we will.
Erez Israeli: No, continue. We can allow that.
Aishwarya Sitharam: The next question is from the line of Krishnendu Saha from Quantum Mutual Fund. Krishnendu, please go ahead.
Krishnendu Saha: Can you hear me? Hello.
Erez Israeli: Yes.
M. V. Narasimham: Yes.
Krishnendu Saha: Yeah. Just quickly, we are supplying to partners like Sandoz, Aspen, and others. Is there any penalty we have to pay for failure to supply?
Aishwarya Sitharam: Failure to supply.
M. V. Narasimham: Here, as per what the orders we received from India, like Torrent and USV. Whatever is as per the agreement, suppose whatever it is, that's already taken care. In case of Sandoz, Aspen, I think at this point of time, we don't expect any such claims.
Krishnendu Saha: Okay. Just to jog my memory, the API is being supplied from a U.S. FDA plant or which plant is it coming from?
M. V. Narasimham: This is from our Vizag plant C206.
Krishnendu Saha: Is it a US-
M. V. Narasimham: It's a U.S. FDA approved plant.
Krishnendu Saha: If there's an OAI from this plant, does our approval in Canada get set back?
Erez Israeli: Sorry.
M. V. Narasimham: There's no OAI.
Erez Israeli: There is no OAI.
Krishnendu Saha: No, just thinking out loud
Erez Israeli: If there were an OAI, it will affect the U.S. Maybe Canada would consider that, but it's very hypothetical because the U.S. inspected the plant already this year, and we got approval. Not relevant.
Krishnendu Saha: Thanks.
Erez Israeli: That's a hypothetical question. Canadian and American are different regimes.
Krishnendu Saha: Yeah. It's from the Indian plant. Okay. This 40 mg which we have exclusivity, how big is the market size? Just for my knowledge, please.
Aishwarya Sitharam: 400 mg, you mean? 400.
Krishnendu Saha: Yeah, sorry. My mistake
Aishwarya Sitharam: Yeah, I think overall the product is a large one. It's in billions.
Krishnendu Saha: Just the 400 mg, any idea?
Aishwarya Sitharam: We will come back on that. Sorry.
M. V. Narasimham: I think Aishwarya will just get back to you.
Krishnendu Saha: How is the nicotine patch doing for us as of now? Any growth rate you're seeing out there? Because it's a profitable business for us. Can you just give me the thoughts on that?
Erez Israeli: It's profitable, it is growing, we are very happy with it. We answered these questions before.
Krishnendu Saha: Thank you.
Erez Israeli: Guys, if we cannot repeat questions, we're happy to give our time, please let us
Krishnendu Saha: Sure. Thank you. Thank you very much.
Aishwarya Sitharam: Just to answer your question, Bosulif is about INR 300 million as far as the market is concerned.
M. V. Narasimham: Market size.
Aishwarya Sitharam: Yeah.
Krishnendu Saha: Yeah, thank you.
Aishwarya Sitharam: The next question is from the line of Rupesh Tatya from Nuvama Institutional Equities. Rupesh, please go ahead.
Rupesh Tatya: Yeah. Hi, am I audible?
Aishwarya Sitharam: Yes.
M. V. Narasimham: Yes.
Rupesh Tatya: My question is on interchangeability in the Canadian market. There are these various provinces, which give out interchangeability designation. Also I think private insurers also give interchangeability designation. Most of these insurers have a clause of mandatory generic substitution. Could you give color on what it takes to get this interchangeability designation and when that happens? my expectation is all of the prescription volume will move to generic. When do we expect that to happen? Any color on that will be helpful. The other aspect also is, the innovator's product is recombinant product, and our product is synthetic product. Does that create some problems for this interchangeability tag?
Erez Israeli: There is no problem with interchangeability in any market. The product is approved as generic, the type of the API doesn't affect it. The semaglutide is approved as a generic product, no issues of interchangeability, you don't need to prove anything beyond the normal submissions. We had to show, obviously, comparability as well as all the relevant safety like immunogenicity and other data.
Rupesh Tatya: Next year, then generic will have 80%, 90% market share in Canada. Is that a fair thing to assume?
Erez Israeli: 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 assume 60% and then will grow.
Rupesh Tatya: Insurance-driven markets. Pardon for interruption. Insurance-driven market. I'm not asking about out-of-pocket or retail.
Erez Israeli: I'm trying to answer that. It started with 60% and likely to go higher. What exactly the number will be, I don't know, but yeah, I believe that as the confidence and the supply will be there, it's going to be primarily generic market. Yeah.
Rupesh Tatya: Okay. Then just quickly, when do we expect Brazil approval for us or any of our partner? Any time estimate you can give?
Erez Israeli: It should be shortly. All the stuff about the rejection that was reversed, and we are expecting approval in the next few weeks.
Rupesh Tatya: Thank you. Thank you for answering my questions.
Aishwarya Sitharam: In the interest of time, we'll take one last question from Saion Mukherjee. I think he's joined back the queue. Saion.
Saion Mukherjee: Thanks for taking the follow-up. Just one question, a couple of questions. In the U.S., I think you mentioned 20-25 launches. How many are we expecting through the rest of the year, and are there any material launches that are lined up or you expect?
Erez Israeli: Altogether right now we are targeting 27. At least, we are supposed to have a reasonable launch, let's call it, I cannot share here the name of the product, already in the next couple of weeks. In the second quarter.
Saion Mukherjee: How large is the opportunity? Can you give an idea about the size or the revenue potential from that launch?
Erez Israeli: It should be in the range of tens of millions of dollars, that specific launch.
Saion Mukherjee: Okay. Thank you. MVN, if you can talk about, I understand biologics and peptide facility operations are not generating 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?
M. V. Narasimham: In the biologics, like already we invested for CCM5, for abatacept, certainly, we are just waiting for approval, and then whatever are the expenses is already hitting our P&L. Similarly, the capacities we have created for peptides, both for API and formulations of fill-finish also, it is there. Once these two products come back, definitely, then it will be profit positive.
Saion Mukherjee: Yeah, I was wondering if you can quantify the amount of cost that you're incurring on account of these two at this point.
M. V. Narasimham: Maybe I'll just come back.
Saion Mukherjee: Okay. Okay.
M. V. Narasimham: Thanks.
Saion Mukherjee: No problem. Thank you. Yeah.
Aishwarya Sitharam: That was the last question. Thanks, Saion. 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 earnings call. Thank you. Thank you, everyone.
