Q1 2027 Zydus Lifesciences Ltd Earnings Call
Operator 2: Ladies and gentlemen, good day and welcome to Zydus Lifesciences Earning Conference Call for Q1 of FY27. Please note all participants' line will be in listen-only mode, and there will be an opportunity for you to ask questions after management's opening remarks. Should you need any assistance during the conference call, please raise your hand from the participant tab on the screen. While asking questions, request you to please identify yourself and your company. Please note this conference is being recorded. I now hand over the call to Mr. Ganesh Nayak, Director at Zydus Lifesciences. Thank you, and over to you, sir.
Operator: Ladies and gentlemen, good day and welcome to Zydus Lifesciences Earning Conference Call for Q1 of FY 2027. Please note all participants' line will be in listen-only mode, and there will be an opportunity for you to ask questions after management's opening remarks. Should you need any assistance during the conference call, please raise your hand from the participant tab on the screen. While asking questions, request you to please identify yourself and your company. Please note this conference is being recorded. I now hand over the call to Mr. Ganesh Nayak, Director at Zydus Lifesciences. Thank you, and over to you, sir.
Speaker #2: Ladies and gentlemen, good day and welcome to the Zydus Lifesciences Earnings Conference Call for Q1 of FY27. Please note, all participants' lines will be in listen-only mode. There will be an opportunity for you to ask questions after the management's opening remarks.
Speaker #2: Should you need any assistance during the conference call, please raise your hand from the participant tab on the screen. While asking questions, we request that you please identify yourself and your company.
Speaker #2: Please note, this conference is being recorded. I now hand over the call to Mr. Ganesh Nayak, Director at Zydus Lifesciences. Thank you, and over to you, sir.
Speaker #3: Good evening, ladies and gentlemen. It is my pleasure to welcome you all to our post-results teleconference for the first quarter ended June 30, 2026. For today's call, we have with us Dr. Shervil Patel, Managing Director; Mr. Tushar Shroff, Chief Financial Officer; Mr. Arvind Bhosra, Head of Investor Relations; and Mr. Alok Garg from the Managing Director's Office.
Ganesh Nayak: Good evening, ladies and gentlemen. It's my pleasure to welcome you all to our post-results teleconference for the first quarter ending 30 June 2026. For today's call, we have with us Dr. Sharvil Patel, Managing Director, Mr. Tushar Shroff, Chief Financial Officer, Mr. Arvind Bothra, Head of Investor Relations, and Saurabh Garg from the Managing Director's office. To begin with, let me talk about the key developments during the quarter. I am happy to report that we commenced FY27 with strong double-digit growth, building on the formidable base of FY26. This performance reflects the sustained momentum across all our key businesses, each of which contributed meaningfully to the overall performance during the quarter. With this, first of all, let me walk you through the financial performance for the quarter under review. We registered consolidated revenues of ₹80.2 billion, up 22% on a year-on-year basis.
Ganesh Nayak: Good evening, ladies and gentlemen. It's my pleasure to welcome you all to our post-results teleconference for the first quarter ending 30 June 2026. For today's call, we have with us Dr. Sharvil Patel, Managing Director, Mr. Tushar Shroff, Chief Financial Officer, Mr. Arvind Bothra, Head of Investor Relations, and Saurabh Garg from the Managing Director's office. To begin with, let me talk about the key developments during the quarter. I am happy to report that we commenced FY 2027 with strong double-digit growth, building on the formidable base of FY 2026. This performance reflects the sustained momentum across all our key businesses, each of which contributed meaningfully to the overall performance during the quarter. With this, first of all, let me walk you through the financial performance for the quarter under review. We registered consolidated revenues of INR 80.2 billion, up 22% on a year-on-year basis.
Speaker #3: To begin with, let me talk about the key developments during the quarter. I'm happy to report that we commenced FY27 with strong double-digit growth, building on the formidable base of FY26.
Speaker #3: This performance reflects the sustained momentum across all our key businesses, each of which contributed meaningfully to the overall performance during the quarter. With this, first of all, let me walk you through the financial performance for the quarter under review.
Speaker #3: We registered consolidated revenues of $80.2 billion, up 22% on a year-on-year basis. On the operating profitability front as well, performance was robust, with an EBITDA margin of 24.1%.
Ganesh Nayak: On the operating profitability front as well, our performance was robust with an EBITDA margin of 24.1%. Consequently, EBITDA for the quarter stood at ₹90.3 billion, while net profit for the quarter stood at ₹9.4 billion. Our net debt to EBITDA ratio stood at 0.7 times as on 30 June 2026. Now let me take you through the operating highlights for the first quarter of FY27 for our key business segments. In the pharmaceutical space in India, our Branded Formulations business sustained market outperformance with a strong 20% year-on-year growth during the quarter. This business has in fact outperformed the market growth consistently over the last three financial years. Growth during the quarter was broad-based as we grew faster than the market in super specialty, chronic, as well as acute segments.
Ganesh Nayak: On the operating profitability front as well, our performance was robust with an EBITDA margin of 24.1%. Consequently, EBITDA for the quarter stood at INR 90.3 billion, while net profit for the quarter stood at INR 9.4 billion. Our net debt to EBITDA ratio stood at 0.7x as on 30 June 2026. Now let me take you through the operating highlights for the first quarter of FY 2027 for our key business segments. In the pharmaceutical space in India, our Branded Formulations business sustained market outperformance with a strong 20% year-on-year growth during the quarter. This business has in fact outperformed the market growth consistently over the last three financial years. Growth during the quarter was broad-based as we grew faster than the market in super specialty, chronic, as well as acute segments.
Speaker #3: Consequently, EBITDA for the quarter stood at $19.3 billion, while net profit for the quarter stood at $9.4 billion. Our net debt-to-EBITDA ratio stood at 0.7 times as on June 30, 2026.
Speaker #3: Now, let me take you through the operating highlights for the first quarter of FY27 for our key business segments. In the pharmaceutical space in India, our branded formulations business sustained market outperformance with a strong 20% year-on-year growth during the quarter.
Speaker #3: This business has, in fact, outperformed market growth consistently over the last three financial years. Growth during the quarter was broad-based, as we grew faster than the market in super specialty, chronic, as well as acute segments.
Speaker #3: In terms of therapy performance, the business grew faster than the market in cardiology, dermatology, gynecology, anti-infectives, pain management, and in the super specialty areas of oncology and nephrology.
Ganesh Nayak: In terms of therapy performance, the business grew faster than the market in cardiology, diabetology, gynecology, anti-infectives, pain management, and in the super specialty areas of oncology and nephrology. Our ranking improved in key therapies of cardiology, diabetology, and pain management, while on the super specialty front, we continued to retain leadership position in the oncology therapy. Our large innovative brands led by LIPITOR continue to strengthen their market standing and improve their rankings quarter after quarter, underscoring the impact of our innovation on improved patient outcomes. Contribution of chronic and subchronic portfolio has increased consistently over the last several years and stood at 54.2% as per AWACS March-June 2026, an improvement of 360 basis points over the last four years.
Ganesh Nayak: In terms of therapy performance, the business grew faster than the market in cardiology, diabetology, gynecology, anti-infectives, pain management, and in the super specialty areas of oncology and nephrology. Our ranking improved in key therapies of cardiology, diabetology, and pain management, while on the super specialty front, we continued to retain leadership position in the oncology therapy. Our large innovative brands led by LIPITOR continue to strengthen their market standing and improve their rankings quarter after quarter, underscoring the impact of our innovation on improved patient outcomes. Contribution of chronic and subchronic portfolio has increased consistently over the last several years and stood at 54.2% as per AWACS March-June 2026, an improvement of 360 basis points over the last four years.
Speaker #3: Our ranking improved in key therapies of cardiology, dermatology, and pain management, while on the super specialty front, we continued to retain our leadership position in the oncology therapy.
Speaker #3: Our large, innovative brands, led by Lipaglyn, continued to strengthen their market standing and improve their rankings quarter after quarter, underscoring the impact of our innovation on improved patient outcomes.
Speaker #3: The contribution of the chronic and sub-chronic portfolio has increased consistently over the last several years, and stood at 54.2% as per AVAX MAC June 2026—an improvement of 360 basis points over the last four years.
Ganesh Nayak: International Market Formulations business has delivered strong growth during the last several quarters and has established itself as a formidable growth pillar for the company. The business sustained the growth momentum during the quarter and posted revenues of INR 9.7 billion with a year-on-year growth of 34%. The growth was led by strong demand-driven performance across markets and supported by focused execution. North America business, comprising of the US and Canada, exhibited resilience with revenues of INR 31 billion during the quarter, up 5% quarter on quarter. The base US business continued to gain share driven by sustained volume expansion, supplemented by new product launches. On the US generics front, we filed five ANDAs, received nine approvals, including four tentative approvals, and launched 11 new products during the quarter. Our US specialty business achieved two important milestones during the quarter.
Ganesh Nayak: International Market Formulations business has delivered strong growth during the last several quarters and has established itself as a formidable growth pillar for the company. The business sustained the growth momentum during the quarter and posted revenues of INR 9.7 billion with a year-on-year growth of 34%. The growth was led by strong demand-driven performance across markets and supported by focused execution. North America business, comprising of the US and Canada, exhibited resilience with revenues of INR 31 billion during the quarter, up 5% quarter on quarter. The base US business continued to gain share driven by sustained volume expansion, supplemented by new product launches. On the US generics front, we filed five ANDAs, received nine approvals, including four tentative approvals, and launched 11 new products during the quarter. Our US specialty business achieved two important milestones during the quarter.
Speaker #3: The international markets formulations business has delivered strong growth during the last several quarters and has established itself as a formidable growth pillar for the company.
Speaker #3: The business sustained its growth momentum during the quarter and posted revenues of $9.7 billion, with year-on-year growth of 34%. The growth was led by strong, demand-driven performance across markets and supported by focused execution.
Speaker #3: North America business, comprising the US and Canada, exhibited resilience with revenues of $31 billion during the quarter, up 5% quarter-on-quarter. The base US business continued to gain share, driven by sustained volume expansion supplemented by new product launches.
Speaker #3: On the US generics front, we find 5 ANDAs received 9 approvals, including 4 tentative approvals, and launched 11 new products during the quarter. Our US specialty business achieved 2 important milestones during the quarter.
Speaker #3: First, we launched Nufemco injection, which is ranibizumab, our first biosimilar in the US market, marking a meaningful expansion of our specialty capabilities and laying the foundation for future participation in the growing biosimilar segment.
Ganesh Nayak: First, we launched Nufymco Injection, which is ranibizumab, our first biosimilar in the US market, marking a meaningful expansion of our specialty capabilities and laying the foundation for future participation in the growing biosimilar segment. Second, we completed the acquisition of Assertio Holdings, significantly strengthening our commercial capabilities, portfolio breadth, and market access in the US specialty space. These milestones underscore our continued focus on building a robust specialty platform in the US and advancing our transition towards a more differentiated, innovation-led business model. In Canada, we received two ANDA approvals and launched two new products during the quarter. Our consumer wellness business recorded revenues of INR 14.3 billion, up 67% year on year. With this, the international business, including the Comfort Click portfolio, delivered a like-to-like growth of 25% while the domestic business grew 5% year on year.
Ganesh Nayak: First, we launched Nufymco Injection, which is ranibizumab, our first biosimilar in the US market, marking a meaningful expansion of our specialty capabilities and laying the foundation for future participation in the growing biosimilar segment. Second, we completed the acquisition of Assertio Holdings, significantly strengthening our commercial capabilities, portfolio breadth, and market access in the US specialty space. These milestones underscore our continued focus on building a robust specialty platform in the US and advancing our transition towards a more differentiated, innovation-led business model. In Canada, we received two ANDA approvals and launched two new products during the quarter. Our consumer wellness business recorded revenues of INR 14.3 billion, up 67% year on year. With this, the international business, including the Comfort Click portfolio, delivered a like-to-like growth of 25% while the domestic business grew 5% year on year.
Speaker #3: Second, we completed the acquisition of Esercio Holdings, significantly strengthening our commercial capabilities, portfolio breadth, and market access in the US specialty space. These milestones underscore our continued focus on building a robust specialty platform in the US and advancing our transition toward a more differentiated, innovation-led business model.
Speaker #3: In Canada, we received 2 ANDA approvals and launched 2 new products during the quarter. Our consumer wellness business recorded revenues of $14.3 billion, up 67% year-on-year. With this, the international business, including the Comfort portfolio, delivered like-to-like growth of 25%, while the domestic business grew 5% year-on-year.
Speaker #3: Within the domestic portfolio, skin and hair care and food and nutrition continued their strong momentum, delivering growth of 35% and 16%, respectively. Seasonal brands, however, declined primarily due to the softer summer season.
Ganesh Nayak: Within the domestic portfolio, skin and haircare and food and nutrition continued their strong momentum, delivering growths of 35% and 16% respectively. Seasonal brands, however, de-grew primarily due to the softer summer season. In the medical devices space, the business registered revenues of INR 2.8 billion during the quarter. We are investing in enhancing our capabilities in the focused therapies, which offer long-term growth potential to create differentiated value. On the operations front, our injectable manufacturing facility at Zydus Biotech Park recently received an Establishment Inspection Report, EIR, with a Voluntary Action Indicated, VAI, classification following a GMP surveillance inspection conducted in April and May 2026. During the quarter, we entered into a joint venture agreement with Sunshine Healthcare to establish a pharmaceutical manufacturing facility in Sri Lanka to strengthen local production and reduce import dependence for the country. Now, this concludes the business review.
Ganesh Nayak: Within the domestic portfolio, skin and haircare and food and nutrition continued their strong momentum, delivering growths of 35% and 16% respectively. Seasonal brands, however, de-grew primarily due to the softer summer season. In the medical devices space, the business registered revenues of INR 2.8 billion during the quarter. We are investing in enhancing our capabilities in the focused therapies, which offer long-term growth potential to create differentiated value. On the operations front, our injectable manufacturing facility at Zydus Biotech Park recently received an Establishment Inspection Report, EIR, with a Voluntary Action Indicated, VAI, classification following a GMP surveillance inspection conducted in April and May 2026. During the quarter, we entered into a joint venture agreement with Sunshine Healthcare to establish a pharmaceutical manufacturing facility in Sri Lanka to strengthen local production and reduce import dependence for the country. Now, this concludes the business review.
Speaker #3: In the medical devices space, the business registered revenues of $2.8 billion during the quarter. We are investing in enhancing our capabilities in focused therapies, which offer long-term growth potential too.
Speaker #3: Create differentiated value. On the operations front, our injectable manufacturing facility at Zydus Biotech Park recently received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification, following a GMP surveillance inspection conducted in April and May 2026.
Speaker #3: During the quarter, we entered into a joint venture agreement with Sunshine Healthcare to establish a pharmaceutical manufacturing facility in Sri Lanka, to strengthen local production and reduce import dependence for the country.
Speaker #3: Now, this concludes the business review. I would now request Dr. Shervil Patel to take you through the key drivers across businesses, as well as initiatives in our innovation program.
Ganesh Nayak: I would now request Dr. Sharvil Patel to take you through the key drivers across businesses as well as initiatives in our innovation program. Thank you.
Ganesh Nayak: I would now request Dr. Sharvil Patel to take you through the key drivers across businesses as well as initiatives in our innovation program. Thank you.
Speaker #3: Thank you.
Speaker #2: Thank you, Mr. Nayak, and good evening, ladies and gentlemen. It's a pleasure to have you all here today on our call. FY27 is off to a great start, with strong performance across the key businesses.
Sharvil Patel: Thank you, Mr. Naik, and good evening, ladies and gentlemen. It is a pleasure to have you all here today on our call. FY2027 is off to a great start with a strong performance across the key businesses. More importantly, we continue to advance our transformation into an innovation-led organization. The share of our branded portfolio in the total revenues has steadily increased over the last several quarters. It accounted for over 55% of our total revenue in Q1 of this year. As our branded business continues to gain scale across markets, we expect their share to exceed two-thirds of our overall revenue over the medium term. I am confident that the strategic choices that we have made over the last several years will build strong growth pillars for us in the long term.
Sharvil Patel: Thank you, Mr. Naik, and good evening, ladies and gentlemen. It is a pleasure to have you all here today on our call. FY2027 is off to a great start with a strong performance across the key businesses. More importantly, we continue to advance our transformation into an innovation-led organization. The share of our branded portfolio in the total revenues has steadily increased over the last several quarters. It accounted for over 55% of our total revenue in Q1 of this year. As our branded business continues to gain scale across markets, we expect their share to exceed two-thirds of our overall revenue over the medium term. I am confident that the strategic choices that we have made over the last several years will build strong growth pillars for us in the long term.
Speaker #2: More importantly, we continue to advance our transformation into an innovation-led organization. The share of our branded portfolio in the total revenues has steadily increased over the last several quarters.
Speaker #2: It accounted for over 55% of our total revenue in the first quarter of this year. As our branded business continues to gain scale across markets, we expect their share to exceed two-thirds of our overall revenue over the medium term.
Speaker #2: I'm confident that the strategic choices we have made over the last several years will build strong growth pillars for us in the long term.
Speaker #2: With our innovation efforts translating into commercial opportunities, a growing branded portfolio, and disciplined execution across businesses, we are well-positioned for our next phase of growth.
Sharvil Patel: With our innovation efforts translating into commercial opportunities, a growing branded portfolio, and disciplined execution across businesses, we are well-positioned for our next phase of growth. On the pharmaceuticals front, our strategy for India Formulations business is working favorably. The branded business delivered a formidable 20% growth during the quarter. In fact, the business has been consistently outperforming the market growth over the last several quarters. A key driver of this outperformance is our chronic portfolio. These therapies continue to gain share and significantly aid to our overall growth momentum. This is further supported by the strong uptake of our innovation and differentiated portfolios. In addition, our brand-building initiatives and a stronger execution focus are delivering clear results. We remain fully confident in our ability to outpace the industry growth and growing sustainably.
Sharvil Patel: With our innovation efforts translating into commercial opportunities, a growing branded portfolio, and disciplined execution across businesses, we are well-positioned for our next phase of growth. On the pharmaceuticals front, our strategy for India Formulations business is working favorably. The branded business delivered a formidable 20% growth during the quarter. In fact, the business has been consistently outperforming the market growth over the last several quarters. A key driver of this outperformance is our chronic portfolio. These therapies continue to gain share and significantly aid to our overall growth momentum. This is further supported by the strong uptake of our innovation and differentiated portfolios. In addition, our brand-building initiatives and a stronger execution focus are delivering clear results. We remain fully confident in our ability to outpace the industry growth and growing sustainably.
Speaker #2: On the pharmaceuticals front, our strategy for the India formulations business is working favorably. The branded business delivered a formidable 20% growth during the quarter. In fact, the business has been consistently outperforming the market growth over the last several quarters.
Speaker #2: A key driver of this outperformance is our chronic portfolio. These therapies continue to gain share and significantly add to our overall growth momentum. This is further supported by the strong uptake of our innovation and differentiated portfolios.
Speaker #2: In addition, our brand-building initiatives and a stronger execution focus are delivering clear results. We remain fully confident in our ability to outpace industry growth and grow sustainably.
Speaker #2: Our international market formulations business continues to deliver strong growth and has emerged as a formidable growth pillar for the company. While our therapy-led strategy continues to drive momentum in the emerging markets, portfolio expansion and deeper market penetration in Europe are supporting this sustained growth momentum across the business.
Sharvil Patel: Our international market formulation business continue to deliver strong growth and has emerged as a formidable growth pillar for the company. While our therapy-led strategy continues to drive momentum in the emerging markets, portfolio expansion and deeper market penetration in Europe are supporting this sustained growth momentum across the business. We have steadily strengthened our position in the US generics market through our diversified portfolios, a stronger execution, and a resilient supply chain. This is reflected in the sustained prescription growth, market share gains, and improved market transfers, reinforcing our position as a trusted generics player in the US. I am pleased to report that our branded business in the US now contributes 10% of our revenue in the US. We expect the share of this segment in the US to continue to increase as our specialty and innovation-led business gains scale.
Sharvil Patel: Our international market formulation business continue to deliver strong growth and has emerged as a formidable growth pillar for the company. While our therapy-led strategy continues to drive momentum in the emerging markets, portfolio expansion and deeper market penetration in Europe are supporting this sustained growth momentum across the business. We have steadily strengthened our position in the US generics market through our diversified portfolios, a stronger execution, and a resilient supply chain. This is reflected in the sustained prescription growth, market share gains, and improved market transfers, reinforcing our position as a trusted generics player in the US. I am pleased to report that our branded business in the US now contributes 10% of our revenue in the US. We expect the share of this segment in the US to continue to increase as our specialty and innovation-led business gains scale.
Speaker #2: We have steadily strengthened our position in the US generics market through our diversified portfolio, stronger execution, and a resilient supply chain. This is reflected in sustained prescription growth, market share gains, and improved market rankings, reinforcing our position as a trusted generics player in the US.
Speaker #2: I'm pleased to report that our branded business in the US now contributes 10% of our revenue in the US. We expect the share of this segment in the US to continue to increase as our specialty and innovation-led business gains scale.
Speaker #2: The growth drivers are firmly in place vis-à-vis the orphan and rare disease franchise, a growing portfolio of 55 D2 products, the recent acquisition of Rovitone, and an NDA submission to the US FDA of Sarovitasa, our first internally developed innovation in the US.
Sharvil Patel: The growth drivers are strongly in place with the orphan and rare disease franchise, a growing portfolio of 505(b)(2) products, the recent acquisition of Assertio, and an NDA submission to the U.S. Food and Drug Administration of saroglitazar, our first internally developed innovation in the US. Collectively, these businesses position us for a sustained shift towards a more differentiated and specialty-driven US portfolio. In the consumer wellness business, we continue to build a future-ready portfolio through innovation, disciplined execution, and data-driven decision-making. Our investments in analytics and digital capabilities are enabling sharper consumer insights, improving resource allocation, and sustainable profit growth. In the MedTech, we continue to strengthen our presence across the orthopedic, cardiology, and nephrology by building a scalable platform for long-term growth. Leveraging Amplitude's orthopedic portfolio and the proprietary ANDI robotic surgical system, we are expanding access to advanced solutions.
Sharvil Patel: The growth drivers are strongly in place with the orphan and rare disease franchise, a growing portfolio of 505(b)(2) products, the recent acquisition of Assertio, and an NDA submission to the U.S. Food and Drug Administration of saroglitazar, our first internally developed innovation in the US. Collectively, these businesses position us for a sustained shift towards a more differentiated and specialty-driven US portfolio. In the consumer wellness business, we continue to build a future-ready portfolio through innovation, disciplined execution, and data-driven decision-making. Our investments in analytics and digital capabilities are enabling sharper consumer insights, improving resource allocation, and sustainable profit growth. In the MedTech, we continue to strengthen our presence across the orthopedic, cardiology, and nephrology by building a scalable platform for long-term growth. Leveraging Amplitude's orthopedic portfolio and the proprietary ANDI robotic surgical system, we are expanding access to advanced solutions.
Speaker #2: Collectively, these businesses position us for a sustained shift towards a more differentiated and specialty-driven U.S. portfolio. In the consumer wellness business, we continue to build a future-ready portfolio through innovation, disciplined execution, and data-driven decision-making.
Speaker #2: Our investments in analytics and digital capabilities are enabling sharper consumer insights, improving resource allocation, and supporting sustainable profit growth. In MedTech, we continue to strengthen our presence across orthopedics, cardiology, and nephrology, while building a scalable platform for long-term growth.
Speaker #2: Leveraging the Amplitude Orthopedic portfolio and the proprietary ANDY-ROBOT Robotic Surgery surgical system, we're expanding access to advanced solutions. At the same time, we're broadening our cardiology offerings and establishing a high-end dialyzer membrane facility to address growing global demand in nephrology.
Sharvil Patel: At the same time, we are broadening our cardiology offering and establishing a high-end dialyzer membrane facility to address growing global demand in nephrology. With this, let me share some material development on the innovation effort during the quarter. On the NC research front, the U.S. Food and Drug Administration granted priority review to our new drug application of saroglitazar magnesium for the treatment of primary biliary cholangitis. Recently, we received also a regulatory approval in India to initiate a phase III clinical trial of Desidustat in patients with sickle cell disease. The study will be conducted in collaboration with Indian Council of Medical Research. Desidustat represents a potentially first-in-class therapeutic opportunity for the treatment of sickle cell disease. On the biotech R&D space, we initiated a phase III clinical trials in India for our second ADC of biosimilar. This development further centers our deep and differentiated biologics pipeline and underscores our capability in developing advanced biologics.
Sharvil Patel: At the same time, we are broadening our cardiology offering and establishing a high-end dialyzer membrane facility to address growing global demand in nephrology. With this, let me share some material development on the innovation effort during the quarter. On the NC research front, the U.S. Food and Drug Administration granted priority review to our new drug application of saroglitazar magnesium for the treatment of primary biliary cholangitis. Recently, we received also a regulatory approval in India to initiate a phase III clinical trial of Desidustat in patients with sickle cell disease. The study will be conducted in collaboration with Indian Council of Medical Research. Desidustat represents a potentially first-in-class therapeutic opportunity for the treatment of sickle cell disease. On the biotech R&D space, we initiated a phase III clinical trials in India for our second ADC of biosimilar. This development further centers our deep and differentiated biologics pipeline and underscores our capability in developing advanced biologics.
Speaker #2: With this, let me share some material developments on the innovation effort during the quarter. On the NCE research front, the US FDA granted priority review to our new drug application of Saroglitazar magnesium for the treatment of primary biliary cholangitis.
Speaker #2: Recently, we also received regulatory approval in India to initiate a Phase 3 clinical trial of DeciduaStat in patients with sickle cell disease.
Speaker #2: The study will be conducted in collaboration with ICMR. Deciduous stat represents the potentially first-in-class therapeutic opportunity for the treatment of sickle cell disease. On the biotech R&D space, we initiated a Phase 3 clinical trial in India for our second ADC or biosimilar.
Speaker #2: This development further strengthens our deep and differentiated biologics pipeline and underscores our capability in developing advanced biologics. It further enhances the long-term growth potential of our biologics franchise.
Sharvil Patel: It further enhances the long-term growth potential of a biologics franchise. On the R&D front, on the vaccines R&D, we completed our phase II trial of the Vi-tetanus toxoid conjugate vaccine and also initiated a phase I trial of our chikungunya vaccine in India. On the global development front, we submitted our dossier of the MR vaccine to World Health Organization. The dossier has been accepted for review. Thank you. Now we can start with the Q&A session. Over to the coordinator for those question and answers.
Sharvil Patel: It further enhances the long-term growth potential of a biologics franchise. On the R&D front, on the vaccines R&D, we completed our phase II trial of the Vi-tetanus toxoid conjugate vaccine and also initiated a phase I trial of our chikungunya vaccine in India. On the global development front, we submitted our dossier of the MR vaccine to World Health Organization. The dossier has been accepted for review. Thank you. Now we can start with the Q&A session. Over to the coordinator for those question and answers.
Speaker #2: On the R&D front, in vaccines R&D, we completed our Phase 2 trial of the BioLens typhoid conjugate vaccine and also initiated a Phase 1 trial of our chikungunya vaccine in India.
Speaker #2: On the global development front, we submitted our dossier of the MR vaccine to WHO. The dossier has been accepted for review. Thank you, and now we can start with the Q&A session.
Speaker #2: Over to the coordinator for the question-and-answer session.
Speaker #3: Thank you, sir. We will now open the call for the Q&A session. We will wait for a few minutes until the queue assembles. We request participants to restrict themselves to two questions and then return to the queue for more questions.
Operator 2: Thank you, sir. We will now open the call for Q&A session. We will wait for a few minutes until the queue assembles. We request participants to restrict to two questions and then return to the queue for more questions. Please raise your hand from the participant tab on the screen to ask the question. The first question is from Kunal Dhamesha.
Operator: Thank you, sir. We will now open the call for Q&A session. We will wait for a few minutes until the queue assembles. We request participants to restrict to two questions and then return to the queue for more questions. Please raise your hand from the participant tab on the screen to ask the question. The first question is from Kunal Dhamesha.
Speaker #3: Please raise your hand from the Participants tab on the screen to ask a question. The first question is from Kunal Damesha.
Kunal Dhamesha: Hi. Good afternoon. This is Kunal from Macquarie. Thank you for the opportunity and congratulations on strong set of numbers. Dr. Sharvil, with Q1 suggesting strong top-line growth, would we be kind of looking at a much higher growth than what we have guided for FY27, which is currently at double digit, is what we have said? That's the first question.
Kunal Dhamesha: Hi. Good afternoon. This is Kunal from Macquarie. Thank you for the opportunity and congratulations on strong set of numbers. Dr. Sharvil, with Q1 suggesting strong top-line growth, would we be kind of looking at a much higher growth than what we have guided for FY 2027, which is currently at double digit, is what we have said? That's the first question.
Speaker #4: Hi, good afternoon. This is Kunal from MyQuery. Thank you for the opportunity and congratulations on a strong set of numbers. Dr. Sherville, with Q1 suggesting strong top line growth, should we be looking at a much higher growth than what we have guided for FY27, which is currently at double digits as we have said?
Speaker #4: So, yeah, that's the first question.
Sharvil Patel: Thank you for the wishes, and I think we continue to stay with the guidelines that we will deliver strong double-digit growth for the year, starting with the first quarter. I think our India business is poised to deliver significantly good traction better than market, at least by 300 to 500 basis points. So we see mid-teen growth continuing for that business. So is our international markets and US being around a single-digit growth. Looking at that, we will still see good growth for the coming year in that end.
Speaker #2: So, thank you for the wishes, and I think we continue to stay with the guidelines that we will deliver strong double-digit growth for the year.
Sharvil Patel: Thank you for the wishes, and I think we continue to stay with the guidelines that we will deliver strong double-digit growth for the year, starting with the first quarter. I think our India business is poised to deliver significantly good traction better than market, at least by 300 to 500 basis points. So we see mid-teen growth continuing for that business. So is our international markets and US being around a single-digit growth. Looking at that, we will still see good growth for the coming year in that end.
Speaker #2: Starting with the first quarter, I think our India business is poised to deliver significantly good traction, better than the market by at least 300 to 500 basis points.
Speaker #2: So, we see mid-teens growth continuing for that business. So is our international markets, and the US being around single-digit growth. So, looking at that, we will still see good growth for the coming year.
Kunal Dhamesha: Sure. For the India business, I think last time we shared the share of the progressive brand, I believe that with a strong growth. Has that gone up meaningfully in this quarter? Should we expect that momentum of progressive brands to kind of continue at that level?
Kunal Dhamesha: Sure. For the India business, I think last time we shared the share of the progressive brand, I believe that with a strong growth. Has that gone up meaningfully in this quarter? Should we expect that momentum of progressive brands to kind of continue at that level?
Speaker #4: Sure, sure. And for the India business—you know, I think last time we shared the share of the progressive brand. I believe that with the strong growth, has that gone up meaningfully in this quarter, and should we expect that momentum of progressive brands to kind of continue at that level?
Speaker #2: Yes, I think we have seen more than expected, exceptionally strong growth in our innovation portfolio, which has beaten our current expectations. Also, on our value-based biosimilars, we have seen a very significant uptake on all brands.
Sharvil Patel: Yes, I think we have seen more than expected exceptional strong growth on our innovation portfolio, which has beaten our current expectations. Also on our value-based biosimilars, we have seen a very significant uptake on all brands. So that has seen a very significant uptake also. I think both of them have significantly aided to this momentum. At the same time, which has also led to an improvement in our chronic basket and growth booster brands. I would say it's all around performance across, but better than expected on the innovation and biosimilar, and also the scaling up of vaccines.
Sharvil Patel: Yes, I think we have seen more than expected exceptional strong growth on our innovation portfolio, which has beaten our current expectations. Also on our value-based biosimilars, we have seen a very significant uptake on all brands. So that has seen a very significant uptake also. I think both of them have significantly aided to this momentum. At the same time, which has also led to an improvement in our chronic basket and growth booster brands. I would say it's all around performance across, but better than expected on the innovation and biosimilar, and also the scaling up of vaccines.
Speaker #2: So, that has seen a very significant uptake also. So, I think both of them have significantly aided this momentum. At the same time, which has also led to an improvement in our chronic basket and our growth booster brand.
Speaker #2: So, I would say it's all-around performance. It's across the board, but better than expected on the innovation and biosimilars, and also the scaling up of vaccines.
Kunal Dhamesha: Okay. The last question that I have is on the overall, some of these new growth drivers. In the medium term, we suggested that the branded pieces will become more than two-thirds of the revenue. Would you say most of these new drivers would aid to our profitability over medium term?
Kunal Dhamesha: Okay. The last question that I have is on the overall, some of these new growth drivers. In the medium term, we suggested that the branded pieces will become more than two-thirds of the revenue. Would you say most of these new drivers would aid to our profitability over medium term?
Speaker #4: Okay. Sure. You know, overall, in terms of some of these new growth drivers, in the medium term, we suggested that the branded pieces will become more than two-thirds of the revenue.
Speaker #4: Right. Would you say most of these new drivers, you know, would aid to our profitability over the medium term?
Sharvil Patel: Yes. I think if I break down into businesses, India and EIM, I agree with what service improvement in our portfolio of branded as well as chronic, we see better profitability. On the US, I would say the only scale-up that we need to do is saroglitazar, which will require investment. But if you take our other portfolio, which is our Sentynl, that is already profitable and is broken even and profitable, and will continue to aid to profitability. We are seeing our portfolio on the also becoming profitable from now and growing. As I said today, it is only 10% of our business, and probably by end of the year, it will cross 15% or more, and we can only see that increasing meaningfully.
Sharvil Patel: Yes. I think if I break down into businesses, India and EIM, I agree with what service improvement in our portfolio of branded as well as chronic, we see better profitability. On the US, I would say the only scale-up that we need to do is saroglitazar, which will require investment. But if you take our other portfolio, which is our Sentynl, that is already profitable and is broken even and profitable, and will continue to aid to profitability. We are seeing our portfolio on the also becoming profitable from now and growing. As I said today, it is only 10% of our business, and probably by end of the year, it will cross 15% or more, and we can only see that increasing meaningfully.
Speaker #2: Yes, so I think if I break it down into businesses—India and EM—I agree that with the improvement in our portfolio of branded as well as chronic, we'll see better profitability.
Speaker #2: On the US, I would say the only scale-up that we need to do is Saro, which will require investment. But if you take our other portfolio, which is our Sentynl, it's already profitable and has broken even and will continue to add to profitability.
Speaker #2: We are seeing our portfolio on the 505 V2 also becoming profitable from now, and growing. And as I said, today it's only 10% of our business, and probably by the end of the year it'll cross 15% or more.
Speaker #2: And we can only see that increasing meaningfully.
Kunal Dhamesha: Sure. Thank you, and all the best.
Kunal Dhamesha: Sure. Thank you, and all the best.
Speaker #4: Sure. Thank you, and all the best.
Speaker #3: Thank you. The next question is from Neha Manpuriya.
Arvind Bothra: Thank you. The next question is from Neha Manpuria.
Operator: Thank you. The next question is from Neha Manpuria.
Neha Manpuria: Thanks for taking my question. My first question is on the increase in the operating cost that we have seen in the current year. Given that we will have the full impact of Assertio as well as saroglitazar spend, how should we think about both the employee cost as well as the SG&A cost? When should we start expecting the incremental saroglitazar cost to flow through? Just an update on our margin guidance. Are we still maintaining the 24% plus margin guidance that we had indicated?
Neha Manpuria: Thanks for taking my question. My first question is on the increase in the operating cost that we have seen in the current year. Given that we will have the full impact of Assertio as well as saroglitazar spend, how should we think about both the employee cost as well as the SG&A cost? When should we start expecting the incremental saroglitazar cost to flow through? Just an update on our margin guidance. Are we still maintaining the 24% plus margin guidance that we had indicated?
Speaker #5: Thanks for taking my question. My first question is on the increase in the operating cost that we have seen in the current year. You know, given that we'll have the full impact of a certior as well as Saro spend, how should we think about, you know, both the employee cost as well as the SG&A cost?
Speaker #5: When should we start expecting the incremental Saro cost to flow through? And, you know, just an update on our margin guidance—are we still maintaining the 24-plus percent margin guidance that we'd indicated?
Sharvil Patel: saroglitazar, there is already certain costs that have started, but we would see an increase in the H2 of the year. Owing to that meaningful increase that we will see in the next H2, we are still guiding towards the 24% kind of margin.
Sharvil Patel: saroglitazar, there is already certain costs that have started, but we would see an increase in the H2 of the year. Owing to that meaningful increase that we will see in the next H2, we are still guiding towards the 24% kind of margin.
Speaker #2: So, Saro, there are already certain costs that have started, but we would see an increase in the second half of the year. Owing to that meaningful increase that we'll see in the second half, we are still guiding towards the 24% kind of margin.
Speaker #5: So, in that case—sorry, sir, go ahead.
Neha Manpuria: In that case,
Neha Manpuria: In that case,
Tushar Shroff: Neha, our-
Tushar Shroff: Neha, our-
Neha Manpuria: Sorry, sir. Go ahead.
Neha Manpuria: Sorry, sir. Go ahead.
Tushar Shroff: Yeah. Our current run rate of about INR 1,900 to INR 2,000 crores, I think that kind of a run rate, I think we should assume as a part of the other expenses, excluding R&D, on a quarterly basis.
Tushar Shroff: Yeah. Our current run rate of about INR 1,900 to INR 2,000 crores, I think that kind of a run rate, I think we should assume as a part of the other expenses, excluding R&D, on a quarterly basis.
Speaker #2: Yeah, so our current run rate of about, you know, ₹1,900 to ₹2,000 crore—I think that kind of a run rate, I think we should assume as a part of the other expenses, excluding R&D, on a quarterly basis.
Neha Manpuria: And this is despite us increasing the spend on saroglitazar?
Neha Manpuria: And this is despite us increasing the spend on saroglitazar?
Speaker #5: And this is despite us increasing the spend on Saro.
Speaker #2: Yeah, it's all inclusive.
Tushar Shroff: Yeah, it is all included.
Tushar Shroff: Yeah, it is all included.
Speaker #5: Okay. And the increase that we have seen quarter on quarter so far, is essentially on the back of, you know, what would, you know, this increase, like sir mentioned, Saro is one of them, but what is the other reason for the sharp increase that we have seen in costs?
Neha Manpuria: Okay. The increase that we have seen quarter-on-quarter so far is essentially on the back of what? This increase, like sir mentioned, Saro is one of them. What is the other reason for the sharp increase that we have seen in costs quarter-on-quarter?
Neha Manpuria: Okay. The increase that we have seen quarter-on-quarter so far is essentially on the back of what? This increase, like sir mentioned, Saro is one of them. What is the other reason for the sharp increase that we have seen in costs quarter-on-quarter?
Speaker #5: You know, quarter on quarter?
Speaker #2: So it's all, you know, acquisition-driven, the impact that we see on the increase in the other expenses. Largely, I would say that almost—like I would say that about 80% of the increase in cost is driven by the acquisitions that we had in the last one year.
Tushar Shroff: It is all acquisition-driven, the impact that we see on increase in the other expenses. Largely, I would say that about 80% is increase in the cost is driven by acquisitions that we had in last one year.
Tushar Shroff: It is all acquisition-driven, the impact that we see on increase in the other expenses. Largely, I would say that about 80% is increase in the cost is driven by acquisitions that we had in last one year.
Speaker #5: That I understand, sir. Year on year, I understand, but even if I look at this number quarter on quarter, you know, it seems like a fairly steep increase.
Neha Manpuria: That I understand, sir. Year-on-year, I understand. Even if I look at this number quarter-on-quarter,
Neha Manpuria: That I understand, sir. Year-on-year, I understand. Even if I look at this number quarter-on-quarter,
Tushar Shroff: Yeah
Tushar Shroff: Yeah
Tushar Shroff: it seems like a fairly steep increase.
Neha Manpuria: it seems like a fairly steep increase.
Sharvil Patel: Quarter on quarter of Zydus and Assertio. Zydus, Assertio, and the paid expenses.
Sharvil Patel: Quarter on quarter of Zydus and Assertio. Zydus, Assertio, and the paid expenses.
Speaker #2: And Zydus and the freight expenses.
Speaker #5: Okay, okay, understood. My second question is on the Capex. We see a pretty sharp increase in Capex this quarter as well. If you could give us some color in terms of where we are spending in terms of Capex, and what the guidance for the full year would be.
Neha Manpuria: Okay. Understood. My second question is on the CapEx. We see a pretty sharp increase in CapEx this quarter as well. If you could give us some color in terms of where we are spending in terms of CapEx and what the guidance for the full year would be.
Neha Manpuria: Okay. Understood. My second question is on the CapEx. We see a pretty sharp increase in CapEx this quarter as well. If you could give us some color in terms of where we are spending in terms of CapEx and what the guidance for the full year would be.
Speaker #2: So, the Capex—from the Capex point of view, I think a meaningful part of it obviously is the setting up of the facilities: SCZ3, which is coming right now; the completion of the expansion that we have done in our existing facilities for higher capacity, including unit one, unit two, unit three, and SCZ.
Sharvil Patel: From the CapEx point of view, I think a meaningful part of it obviously is setting up of the facilities at Zydus 3, which is coming right now, the completion of the expansion that we have done in our existing facilities for higher capacity, including Moraiya, Bua, Baddi, and then unit 2, unit 3, and Zydus SEZ II. We are also building a new, higher, bigger R&D center for formulations development, which has happened. There is one-off investment in wellness for a larger land acquisition for future facility, which is little exceptionally for one time kind of investment. Then it is the new Karti facility that we built for biologics, a new vaccine DS facility. There are multiple things that have led to this increase, including some investment that continues in Zydus also. It is a whole host of many things.
Sharvil Patel: From the CapEx point of view, I think a meaningful part of it obviously is setting up of the facilities at Zydus 3, which is coming right now, the completion of the expansion that we have done in our existing facilities for higher capacity, including Moraiya, Bua, Baddi, and then unit 2, unit 3, and Zydus SEZ II. We are also building a new, higher, bigger R&D center for formulations development, which has happened. There is one-off investment in wellness for a larger land acquisition for future facility, which is little exceptionally for one time kind of investment. Then it is the new Karti facility that we built for biologics, a new vaccine DS facility. There are multiple things that have led to this increase, including some investment that continues in Zydus also. It is a whole host of many things.
Speaker #2: We are also building a new, higher, bigger R&D center for formulations development, which has happened. There's a one-off investment in wellness for a larger land acquisition for a future facility.
Speaker #2: Which is a little exceptional for a one-time kind of investment. And then it's the new CAR-T facility that we built for biologics, and the new vaccines DS facility.
Speaker #2: So, there are multiple things that have led to this increase, including some investment that continues in Zydus also. So, it's a whole host of many things.
Speaker #2: So, it is not one particular thing that is the large item, other than the wellness land acquisition, but rather multiple investments in increasing scale and capacity in existing and new capabilities.
Sharvil Patel: It is not one particular thing that is the large item, other than the wellness land acquisition, but multiple investments in increasing scale and capacity in existing and new capabilities.
Sharvil Patel: It is not one particular thing that is the large item, other than the wellness land acquisition, but multiple investments in increasing scale and capacity in existing and new capabilities.
Speaker #5: And for the full year, what would this number be in that case?
Neha Manpuria: And for the full year, what would this number be in that case?
Neha Manpuria: And for the full year, what would this number be in that case?
Speaker #2: So yes, right now, we are guiding for around ₹1,500 to ₹1,600 crore of Capex.
Sharvil Patel: We are right now guiding for around INR 1,500 to INR 1,600 crore CapEx.
Sharvil Patel: We are right now guiding for around INR 1,500 to INR 1,600 crore CapEx.
Speaker #5: Understood. And for Saro, you know, based on, you know, given that we have the TAD coming in the later part of this year, you know, how should we think about, you know, the ramp-up of market share there?
Neha Manpuria: Understood. For saroglitazar, given that we have the TAD coming in the later part of this year, how should we think about the ramp-up of market share there? If you could give us some color to help us understand in terms of what the sales opportunity could be.
Neha Manpuria: Understood. For saroglitazar, given that we have the TAD coming in the later part of this year, how should we think about the ramp-up of market share there? If you could give us some color to help us understand in terms of what the sales opportunity could be.
Speaker #5: You know, if you could give us some color to help us understand what the sales opportunity could be.
Speaker #2: So, on Saro, I mean, we are building for a next S528 launch right now, so an April launch. And we are investing for that. The first year, first three years—I mean, first two years—will just be the build-up of this.
Sharvil Patel: On saroglitazar, we are building for our next FY28 launch right now, so April launch. We are investing for that. The first two years will be just a buildup of this. We will not see any significant revenue in the first year, large. As we move into second and third year, we would see the revenue mark build up. I think first two years will look more from an investment point of view as to how much we are investing. On the market point of view, obviously, if you see the recent guidance from both the other competitors in the current segment, they are seeing better traction than their earlier guidance, and they have upgraded some of their guidances. That is led from higher patients, bigger patient pool and more patients wanting to access this indication.
Sharvil Patel: On saroglitazar, we are building for our next FY 2028 launch right now, so April launch. We are investing for that. The first two years will be just a buildup of this. We will not see any significant revenue in the first year, large. As we move into second and third year, we would see the revenue mark build up. I think first two years will look more from an investment point of view as to how much we are investing. On the market point of view, obviously, if you see the recent guidance from both the other competitors in the current segment, they are seeing better traction than their earlier guidance, and they have upgraded some of their guidances. That is led from higher patients, bigger patient pool and more patients wanting to access this indication.
Speaker #2: So, we won't see any significant revenue in the first year. But as we move into the second and third years, we would see the revenue build up.
Speaker #2: So I think the first two years will look more, from an investment point of view, at how much we're investing. On the market point of view, obviously, if you see the recent guidance from both our competitors in the current segment, they are seeing better traction than their earlier guidance, and they've upgraded some of their guidances.
Speaker #2: And that is led from higher patients, a bigger patient pool, and more patients wanting to access this indication. So we are seeing a positive in terms of the market being a bigger market than expected.
Sharvil Patel: We are seeing a positive in terms of market, being a bigger market than expected. We are only seeing some positive signs in terms of how this market formation is happening, and we are quite excited with that opportunity.
Sharvil Patel: We are seeing a positive in terms of market, being a bigger market than expected. We are only seeing some positive signs in terms of how this market formation is happening, and we are quite excited with that opportunity.
Speaker #2: So, we are only seeing some positive signs in terms of how this market formation is happening, and are quite excited with that opportunity.
Neha Manpuria: Noted, sir. Any indication that you would want to give on target market share, or let's say, peak sales that we expect from this product?
Neha Manpuria: Noted, sir. Any indication that you would want to give on target market share, or let's say, peak sales that we expect from this product?
Speaker #5: Noted, sir. Is there any indication you would like to give on target market share, or, let's say, peak sales that we expect from this product?
Speaker #2: So, as I have always said, on our conservative side we're looking at a $200 to $300 million range, and maybe, more optimistically, we can cross the $400 million-plus mark.
Sharvil Patel: As I always say, on our conservative side, we are looking at a $200 to 300 million range, and maybe more optimistic, we can cross the $400 plus million range.
Sharvil Patel: As I always say, on our conservative side, we are looking at a $200 to 300 million range, and maybe more optimistic, we can cross the $400 plus million range.
Neha Manpuria: Understood. Okay. That is helpful, sir. Thank you.
Neha Manpuria: Understood. Okay. That is helpful, sir. Thank you.
Speaker #5: Understood. Okay, that's helpful, sir. Thank you.
Speaker #3: Thank you. Next question is from Sayan Kurdi.
Operator 2: Thank you. The next question is from Saion Mukherjee.
Operator: Thank you. The next question is from Saion Mukherjee.
Saion Mukherjee: Hi. Thanks for taking my question. On the US, sir, you mentioned currently we have 10% of revenues coming from branded. That would mean roughly, let's say, $130 million, $335 million of revenues on an annual basis. How is that, like, the rare disease would be like $40 million, $50 million, and if you can throw some light, what are the other constituents, and whether Assertio is a significant number in this?
Saion Mukherjee: Hi. Thanks for taking my question. On the US, sir, you mentioned currently we have 10% of revenues coming from branded. That would mean roughly, let's say, $130 million, $335 million of revenues on an annual basis. How is that, like, the rare disease would be like $40 million, $50 million, and if you can throw some light, what are the other constituents, and whether Assertio is a significant number in this?
Speaker #4: Hi, thanks for taking my question. On the US, sir, you mentioned currently we have 10% of revenues coming from branded. So that would mean roughly, let's say, $130–$135 million, right?
Speaker #4: Of revenues on an annual basis—how is that? You know, the rare disease would be like $40–50 million. And if you can throw some light, what are the other constituents, and whether SR show is a significant number in this?
Sharvil Patel: Currently in this quarter, which is 10%, we do not have any Assertio made number fully. Last year, 10% was around $60 million, which is the ultra-rare disease business.
Speaker #2: So currently, in this quarter, which is 10%, we don't have the number fully. I mean, our last year 10% was around $60 million, which is the ultra-rare disease business.
Sharvil Patel: Currently in this quarter, which is 10%, we do not have any Assertio made number fully. Last year, 10% was around $60 million, which is the ultra-rare disease business.
Saion Mukherjee: Okay.
Saion Mukherjee: Okay.
Speaker #2: And I think we start adding from the coming quarter. That's why we said the numbers, from the analyst point of view, will go up towards 15%, because those numbers are still to be baked in.
Sharvil Patel: I think we start adding from the coming quarter. That is why we said the numbers from an analyst point of view will go up towards 15%, because those numbers are still to be baked in.
Sharvil Patel: I think we start adding from the coming quarter. That is why we said the numbers from an analyst point of view will go up towards 15%, because those numbers are still to be baked in.
Speaker #4: Understood. So you're saying rare disease is around $60 million, and the remaining $60–70 million is like 505(b)(2) products. Would that be a right way to think about it?
Saion Mukherjee: Understood. You are saying, rare disease is around USD 60 million, and the remaining USD 60, USD 70 million is like 505(b)(2) products. Would that be a right way to think about that?
Saion Mukherjee: Understood. You are saying, rare disease is around USD 60 million, and the remaining USD 60, USD 70 million is like 505(b)(2) products. Would that be a right way to think about that?
Speaker #2: There are some, yeah, there is a cluster of 505(b)(2) products.
Sharvil Patel: Yeah. They have a cluster of 505(b)(2) products.
Sharvil Patel: Yeah. They have a cluster of 505(b)(2) products.
Speaker #4: Okay, okay. And sir, this SR show acquisition, Rolvidon sales—how should we think about the contribution this year and next year? What's the expectation there?
Saion Mukherjee: Okay. And sir, this Assertio acquisition, ROLVEDON sales, how should we think about the contribution this year, next year? What is the expectation there?
Saion Mukherjee: Okay. And sir, this Assertio acquisition, ROLVEDON sales, how should we think about the contribution this year, next year? What is the expectation there?
Sharvil Patel: Well, I think we have just begun, so it seems to be on track. We are looking at around
Sharvil Patel: Well, I think we have just begun, so it seems to be on track. We are looking at around
Speaker #2: So, I think we are—this is—we have just begun, so it seems to be on track. We are looking at around $15 to $20 million per quarter run rate.
Tushar Shroff: INR 20 million.
Tushar Shroff: INR 20 million.
Sharvil Patel: INR 50 to 20 million per quarter run rate.
Sharvil Patel: INR 50 to 20 million per quarter run rate.
Saion Mukherjee: We would see that from next quarter, right?
Speaker #4: And this, we would see from next quarter, right?
Saion Mukherjee: We would see that from next quarter, right?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Saion Mukherjee: Understood. Sir, on the India business, we have seen good growth here. I mean, what is really driving? If you can give some color. Of course, you mentioned about innovation asset, maybe how is semaglutide done? If you can give some color here. I am just wondering what is the sustainable number, let us say, if I take a two, three-year horizon, how should we think about the growth for India business?
Saion Mukherjee: Understood. Sir, on the India business, we have seen good growth here. I mean, what is really driving? If you can give some color. Of course, you mentioned about innovation asset, maybe how is semaglutide done? If you can give some color here. I am just wondering what is the sustainable number, let us say, if I take a two, three-year horizon, how should we think about the growth for India business?
Speaker #4: Understood, understood. And sir, on the India business, we have seen good growth here. If you can, you know, I mean, what’s really driving it? If you can give some color—of course you mentioned about innovation as a lever—maybe, you know, how has semaglutide done?
Speaker #4: If you can give some color here, I'm just wondering what's the sustainable number. Let's say if I take a two- to three-year horizon, how should we think about the growth for the India business?
Speaker #2: So I think—I mean, I'll try and maybe summarize a little better. I think there are two or three things. One is, overall, the chronic part of our business is growing.
Sharvil Patel: I think, I will try and maybe summarize a little better. I think there are two, three things. One is overall chronic part of our business is growing at more than 20%. If you look at even July numbers that has been reported by the AWACS, we are seeing strong traction on the chronic side of therapies and growing very meaningfully in that role. The second is we are seeing a very meaningful uptake on saroglitazar and Desidustat which is adding quite meaningfully almost 30% to 45% kind of growth in this business. That's also adding very meaningfully and scaling up, and we see that traction continuing. The other third is our biologics have seen extremely good traction on three or four brands, which have also very, very significantly scaled after genericization also. We are seeing very strong momentum on growth.
Sharvil Patel: I think, I will try and maybe summarize a little better. I think there are two, three things. One is overall chronic part of our business is growing at more than 20%. If you look at even July numbers that has been reported by the AWACS, we are seeing strong traction on the chronic side of therapies and growing very meaningfully in that role. The second is we are seeing a very meaningful uptake on saroglitazar and Desidustat which is adding quite meaningfully almost 30% to 45% kind of growth in this business. That's also adding very meaningfully and scaling up, and we see that traction continuing. The other third is our biologics have seen extremely good traction on three or four brands, which have also very, very significantly scaled after genericization also. We are seeing very strong momentum on growth.
Speaker #2: I mean, at more than 20%. And if you look at even July numbers, that has been reported by the AVAX, listing strong traction on the chronic side of the therapies.
Speaker #2: And growing very meaningfully, which has driven that growth. The second is, we are seeing a very meaningful uptake on Saro and Desi, which is adding quite meaningfully—almost 30% to 45% kind of growth in this business.
Speaker #2: So that's also adding very meaningfully and scaling up, and we see that traction continuing. The other third is our biologics have seen extremely good traction on three or four brands, which have also very, very significantly scaled after genericization also.
Speaker #2: So we are seeing very strong momentum on those. And Sema is just the beginning, so it is a small contributor. We are third to fourth in market share today in our own brand, but overall, we are the largest as a semaglutide innovative generic that we have launched.
Sharvil Patel: Semaglutide is just the beginning, so it is a small contributor. We are third to fourth in market share today in our own brand, but overall we are largest as a semaglutide innovative generic that we've launched. That also is adding to the momentum. I would say just the whole differentiated pipeline and the chronic business both helping this growth, and we see that sustaining going forward.
Sharvil Patel: Semaglutide is just the beginning, so it is a small contributor. We are third to fourth in market share today in our own brand, but overall we are largest as a semaglutide innovative generic that we've launched. That also is adding to the momentum. I would say just the whole differentiated pipeline and the chronic business both helping this growth, and we see that sustaining going forward.
Speaker #2: So that also is adding to the momentum. So, I would say just the whole differentiated pipeline and the chronic business are both helping this growth.
Speaker #2: And we see that sustaining going forward.
Speaker #4: Understood. Sir, I know the ₹6,500 crores of revenues that was booked last year. How much would be biologics, innovation, and vaccine in that? If you can give a rough percentage.
Saion Mukherjee: Understood. Sir, I know the INR 6,500 crores of revenues that was booked last year, how much would be biologics, innovation, and vaccine in that? If you can give a rough percentage.
Saion Mukherjee: Understood. Sir, I know the INR 6,500 crores of revenues that was booked last year, how much would be biologics, innovation, and vaccine in that? If you can give a rough percentage.
Speaker #2: So we are not given any breakup because it's all in different divisions, which have multiple brands, both chronic and this. So we don't track them separately.
Sharvil Patel: We're not given any breakup because it's all these different divisions which have multiple brands, both chronic and this. We don't track them separately. But as I said, oncology portfolio is the fastest growing and then followed by the chronic portfolio. Then vaccines is obviously a very different business, which I always said that we want to achieve the INR 300 to 400 crore mark, and we are on track to achieve that.
Sharvil Patel: We're not given any breakup because it's all these different divisions which have multiple brands, both chronic and this. We don't track them separately. But as I said, oncology portfolio is the fastest growing and then followed by the chronic portfolio. Then vaccines is obviously a very different business, which I always said that we want to achieve the INR 300 to 400 crore mark, and we are on track to achieve that.
Speaker #2: But as I said, oncology portfolio is the fastest growing. And then followed by the chronic portfolio. And then vaccines is obviously a very different business, which is which we know I always said that we want to achieve the 300 to 400 kind of growth mark.
Speaker #2: And we are on track to achieve that.
Speaker #4: Understood. Sir, if I can ask one last question, which is on the international formulation. You know, we have crossed $100 million of revenues this quarter.
Saion Mukherjee: Understood. Sir, if I can ask one last question, which is on the international formulation. We have crossed USD 100 million of revenues this quarter, and the growth has been exceptionally strong. I would appreciate if you can give some granular color on this, either in terms of geographic segment or product segment, which is driving this. Again, the question is around sustainability of very strong double-digit growth from, let's say, next 2, 3 years perspective.
Saion Mukherjee: Understood. Sir, if I can ask one last question, which is on the international formulation. We have crossed USD 100 million of revenues this quarter, and the growth has been exceptionally strong. I would appreciate if you can give some granular color on this, either in terms of geographic segment or product segment, which is driving this. Again, the question is around sustainability of very strong double-digit growth from, let's say, next 2, 3 years perspective.
Speaker #4: And the growth has been exceptionally strong. I would appreciate it if you could give some granular color on this, either in terms of geographic segment or product segment—what is driving this?
Speaker #4: And again, the question is around, you know, sustainability of very strong double-digit growth from, let's say, a next two- to three-year perspective.
Speaker #2: So, I think three things. One is our core existing markets have delivered. On the emerging market front, they continue to do better than last year and are growing very strongly.
Sharvil Patel: Well, I think three things. One is our core existing markets have delivered on the emerging market front delivered. They continue to do better than last year and are growing very strongly. The second is Europe, which used to be a little difficult business for us in terms of growth. As two things have changed, both our core old markets of France and Spain have significantly delivered on growth, and they continue to see a very strong traction on that. Our new market entry of UK has scaled up much faster than expected, and is also becoming a very important business for us. So that international part in terms of EU has started doing extremely well in terms of the revenue.
Sharvil Patel: Well, I think three things. One is our core existing markets have delivered on the emerging market front delivered. They continue to do better than last year and are growing very strongly. The second is Europe, which used to be a little difficult business for us in terms of growth. As two things have changed, both our core old markets of France and Spain have significantly delivered on growth, and they continue to see a very strong traction on that. Our new market entry of UK has scaled up much faster than expected, and is also becoming a very important business for us. So that international part in terms of EU has started doing extremely well in terms of the revenue.
Speaker #2: The second is Europe, which used to be a little difficult business for us because of growth, has done—two things have changed. Both our core old markets, France and Spain, have significantly delivered on growth, and they continue to see very strong traction on that.
Speaker #2: And our new market entry in the UK has scaled up much faster than expected, and it is also becoming a very important business for us. So that international part, in terms of the EU, has started doing extremely well in terms of revenue.
Speaker #2: And the third is, we entered new geographies, and in those geographies we are seeing either innovative pipeline or first-generic kind of launches in many markets, which is seeing good, healthy traction in terms of commercialization.
Sharvil Patel: The third is we entered new geographies, and those geographies we are seeing our innovative pipeline, our first generic kind of launches in many markets, which is seeing a good, healthy traction in terms of commercialization. So I think all in all these three things are helping core markets, the Europe doing much better and the new markets meaningfully scaling up.
Sharvil Patel: The third is we entered new geographies, and those geographies we are seeing our innovative pipeline, our first generic kind of launches in many markets, which is seeing a good, healthy traction in terms of commercialization. So I think all in all these three things are helping core markets, the Europe doing much better and the new markets meaningfully scaling up.
Speaker #2: So I think, all in all, all these three things are helping core markets, Europe is doing much better, and the new markets are meaningfully scaling up.
Saion Mukherjee: Right, sir. Thank you very much.
Saion Mukherjee: Right, sir. Thank you very much.
Speaker #4: Right, sir. Thank you very much.
Operator 2: Thank you. The next question is from Bino. Hello? Hi, Bino. Are you able to unmute yourself and ask the question?
Operator: Thank you. The next question is from Bino. Hello? Hi, Bino. Are you able to unmute yourself and ask the question?
Speaker #2: Thank you.
Speaker #1: The next question is from Bino.
Speaker #2: Hello?
Speaker #1: Hi, Bino. Are you able to unmute yourself and ask a question?
Speaker #2: I think he's unmuted, but.
Sharvil Patel: I think he's unmuted but.
Sharvil Patel: I think he's unmuted but.
Operator 2: Yeah. We might move to the next. The next question is from Vamshi.
Operator: Yeah. We might move to the next. The next question is from Vamshi.
Speaker #1: Yeah. We might move to the next. The next question is from Vamsee.
[Analyst] (Kotak Securities): Hi, sir. Am I audible?
Vamshi Krishna: Hi, sir. Am I audible?
Speaker #4: Hi, sir. Am I audible?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Speaker #1: Yes.
Speaker #4: Thanks for taking my question, and congratulations on the good set of numbers. So, my first question is in terms of the 505(b)(2) portfolio that we have.
[Analyst] (Kotak Securities): Thanks for taking my question and congrats on the good set of numbers. My first question is in terms of the 505(b)(2) portfolio that we have. Of the 20 assets, if I am not wrong, close to five have been commercialized. How do you expect the overall portfolio to ramp up in terms of the launches which are scheduled for the rest of the year? In terms of the steady-state sales, I remember in one of the calls we have guided that some of these assets could hit a $50 million kind of mark each. How is that kind of panning out at this point of time?
Vamshi Krishna: Thanks for taking my question and congrats on the good set of numbers. My first question is in terms of the 505(b)(2) portfolio that we have. Of the 20 assets, if I am not wrong, close to five have been commercialized. How do you expect the overall portfolio to ramp up in terms of the launches which are scheduled for the rest of the year? In terms of the steady-state sales, I remember in one of the calls we have guided that some of these assets could hit a $50 million kind of mark each. How is that kind of panning out at this point of time?
Speaker #4: So of the 20 assets, if I'm not wrong, close to five have been commercialized. So how much of, you know, how do you expect the overall portfolio to ramp up in terms of the launches that are going to schedule, which are scheduled for the rest of the year?
Speaker #4: And in terms of the steady state sales, I remember in one of the calls we had guided that, you know, some of these assets could hit a $50 million kind of mark each.
Speaker #4: So, how is that kind of panning out at this point in time?
Speaker #2: So, on our 505(b)(2), we have a good mix of our own products and licensed products also. We have about 19 products that we have from our in-house and own pipeline creation.
Sharvil Patel: On our 505(b)(2) we have a good mix of our own products and licensed products also. We have about 19 products that we have from our in-house and own pipeline creation. We have partner products which are about eight that we are working on in different areas. We have commercialized four plus products now, as we said, and we have more products in the pipeline. I think it is a pipeline that we are trying to develop for the market. From the current point of view, I would say most of them are doing better than expected. I think the going out rate is lower than what we had expected, and we hope, in the next financial year, we will see a bigger scale-up. Beyond that, the other two, three products that we have launched are doing extremely well.
Sharvil Patel: On our 505(b)(2) we have a good mix of our own products and licensed products also. We have about 19 products that we have from our in-house and own pipeline creation. We have partner products which are about eight that we are working on in different areas. We have commercialized four plus products now, as we said, and we have more products in the pipeline. I think it is a pipeline that we are trying to develop for the market. From the current point of view, I would say most of them are doing better than expected. I think the going out rate is lower than what we had expected, and we hope, in the next financial year, we will see a bigger scale-up. Beyond that, the other two, three products that we have launched are doing extremely well.
Speaker #2: We have partnered products, which are about eight, that we are working on in different areas. We have commercialized four-plus products now, as you said.
Speaker #2: And we have more products in the pipeline. So I think it's a pipeline that we are trying to develop for the markets. From the current point of view, I would say that most of them are doing better than expected.
Speaker #2: I think the going-out deal trajectory is slower than what we had expected, and we hope that in the next financial year we'll see a much bigger scale-up.
Speaker #2: But beyond that, the other two or three products that we have launched are doing extremely well. At the same time, Rolvedon will add meaningfully to that business going forward.
Sharvil Patel: At the same time, ROLVEDON will add meaningfully to that business going forward. The biosimilars launch, initial launch of ranibizumab and with the PSS coming next year and also further products, we will see good uptake on that. Also the specialty rare disease business on Sentynl, which has meaningfully started to do well. All in all, I think that is doing well and growing well.
Sharvil Patel: At the same time, ROLVEDON will add meaningfully to that business going forward. The biosimilars launch, initial launch of ranibizumab and with the PSS coming next year and also further products, we will see good uptake on that. Also the specialty rare disease business on Sentynl, which has meaningfully started to do well. All in all, I think that is doing well and growing well.
Speaker #2: And then the biosimilars launch—the initial launch of Ranibizumab—and with the PFS coming next year, and also further products, we will see good uptake on that.
Speaker #2: And also, our specialty rare disease business on Sentinel, which has meaningfully started to do well. So, all in all, I think that's doing well.
Speaker #2: And it's growing well.
Speaker #4: Thank you, sir. If I may, I would also like to ask a couple of questions around the liquids portfolio. Currently, how big is this in terms of overall contribution? And how many of the overall 505(b)(2) assets within the liquids portfolio have already been commercialized?
[Analyst] (Kotak Securities): Thank you, sir. If I just may also ask a couple of questions around the liquids portfolio. Currently, how big is this in terms of the overall contribution? How many of the overall 505(b)(2) assets within the liquids portfolio have already been commercialized?
Vamshi Krishna: Thank you, sir. If I just may also ask a couple of questions around the liquids portfolio. Currently, how big is this in terms of the overall contribution? How many of the overall 505(b)(2) assets within the liquids portfolio have already been commercialized?
Speaker #2: So we have around seven launches, I think, and we have 10-plus approvals. And we continue to create a larger pipeline.
Sharvil Patel: We have around seven launches, I think, and we have 10 plus approvals, and we continue to create a more larger pipeline.
Sharvil Patel: We have around seven launches, I think, and we have 10 plus approvals, and we continue to create a more larger pipeline.
Speaker #4: Understood, sir. And lastly, also on Zydus Chat, any update in terms of, you know, our China partner launching it in the Chinese market, and how the ramp-up is happening there?
[Analyst] (Kotak Securities): Understood, sir. Lastly also on Desidustat, any update in terms of our China partner launching it in the Chinese market and how the ramp-up is happening there? How big of an opportunity do you think it could be over the next couple of years?
Vamshi Krishna: Understood, sir. Lastly also on Desidustat, any update in terms of our China partner launching it in the Chinese market and how the ramp-up is happening there? How big of an opportunity do you think it could be over the next couple of years?
Speaker #4: And how big of an opportunity do you think it could be over the next couple of years?
Speaker #2: So yes, I think we have achieved the milestones of getting it approved in China now. The supply of the API for formulation manufacturing is now in the market.
Sharvil Patel: Yes. I think we have achieved the milestones of getting it approved in China now. We have supply now API for formulation manufacturing in their market. This product is nationally reimbursed in the drug list. Obviously, we need to get an approval in the NRDL to gain major part of the share. Having looked at that, there are 120 million CKD patients in China, so it is a very large market. The prevalence of anemia is very strong in that market. Looking at all of that, and looking at how the peers have done in this space, we see it as a good opportunity. But first we need to go through the registration and making sure it is available through the reimbursement phase. Once the reimbursement phase goes through, then we can see an uptake in that business.
Sharvil Patel: Yes. I think we have achieved the milestones of getting it approved in China now. We have supply now API for formulation manufacturing in their market. This product is nationally reimbursed in the drug list. Obviously, we need to get an approval in the NRDL to gain major part of the share. Having looked at that, there are 120 million CKD patients in China, so it is a very large market. The prevalence of anemia is very strong in that market. Looking at all of that, and looking at how the peers have done in this space, we see it as a good opportunity. But first we need to go through the registration and making sure it is available through the reimbursement phase. Once the reimbursement phase goes through, then we can see an uptake in that business.
Speaker #2: The time this product is nationally reimbursed in the drug list. So, obviously, we need to get an approval through the NRDL to gain a major part of the share.
Speaker #2: But having looked at that, you know, there are 120 million CKD patients in China, so it's a very, very large market. And the prevalence of anemia is very high in that market.
Speaker #2: So, looking at all of that, and looking at how the players have done in this space, we see it as a good opportunity.
Speaker #2: But first, we need to go through the registration and make sure it is available through the reimbursement state. And once the reimbursement phase goes through, then we can see an uptick in that business.
Sharvil Patel: Maybe in a couple of quarters, we can give more highlight, but we see this being a decent opportunity, a long-term opportunity, but we will have to wait for another two to three quarters to make sure that all the important approvals go through and the access to the molecule is created in the list.
Speaker #2: So maybe in a couple of quarters, we can give more highlight. But we see this being a decent opportunity—a long-term opportunity—but we'll have to wait for another two to three quarters to make sure that all the important approvals go through and the access to the molecule is created in the list.
Sharvil Patel: Maybe in a couple of quarters, we can give more highlight, but we see this being a decent opportunity, a long-term opportunity, but we will have to wait for another two to three quarters to make sure that all the important approvals go through and the access to the molecule is created in the list.
Speaker #4: Understood, sir. Just one last question. So, given that it's an NCE asset, and I presume that, of course, it will also be under patent protection in the Chinese market.
[Analyst] (Kotak Securities): Understood, sir. Just one last question. Given that it is an NT asset, and I presume that of course it will also be under patent protection in the Chinese market. If not as big as Saro in comparison, how much of steady state sales could this asset generate once it reaches, let us say, 3 to 4 years down the line? What kind of top-line contribution could be coming from this product from the China market?
Vamshi Krishna: Understood, sir. Just one last question. Given that it is an NT asset, and I presume that of course it will also be under patent protection in the Chinese market. If not as big as Saro in comparison, how much of steady state sales could this asset generate once it reaches, let us say, 3 to 4 years down the line? What kind of top-line contribution could be coming from this product from the China market?
Speaker #4: So if not as big as Saro for the in comparison, like how much of steady state sales for this asset generate once it reaches its, let's say, three to four years down the line, what kind of, you know, toppling contribution could be coming from this product?
Speaker #4: From the China market?
Sharvil Patel: See, the opportunity is very difficult to say right now. We have not factored in any meaningful scale in terms of our current year. But as we get experience in terms of it getting reimbursement through, then we can see it importantly doing well because the other molecule is doing very well, which is already launched. I think they are doing about $200 plus million in the Chinese market. We can see it also being a meaningful contributor to us.
Sharvil Patel: See, the opportunity is very difficult to say right now. We have not factored in any meaningful scale in terms of our current year. But as we get experience in terms of it getting reimbursement through, then we can see it importantly doing well because the other molecule is doing very well, which is already launched. I think they are doing about $200 plus million in the Chinese market. We can see it also being a meaningful contributor to us.
Speaker #2: See, the opportunity is very difficult to say right now. We have not factored in any meaningful scale in terms of our current year. But as we get experience, in terms of it getting reimbursement through, then we can see it's importantly doing well.
Speaker #2: Because the other molecule is doing very well, which is already launched. And I think they are doing about $200-plus million in the Chinese market.
Speaker #2: So we can see it also being a meaningful contributor for us.
Speaker #4: Thank you, sir. Thanks for answering my questions, and all the very best.
[Analyst] (Kotak Securities): Thank you, sir. Thanks for answering my questions, and all the very best.
Vamshi Krishna: Thank you, sir. Thanks for answering my questions, and all the very best.
Speaker #1: Thank you. The next question is from Kunal Damesha.
Operator 2: Thank you. The next question is from Kunal Dhamesha.
Operator: Thank you. The next question is from Kunal Dhamesha.
Speaker #5: Hello. Can you hear me?
Kunal Dhamesha: Hello, can you hear me?
Kunal Dhamesha: Hello, can you hear me?
Speaker #2: Yes.
Operator 2: Yes.
Operator: Yes.
Speaker #5: Yeah. Dr. Sherwood, one question on Saro Greta Zar. So for the incremental addressable patient pool, when do we need to do additional studies? If yes, you know, what would be the size, scope, and duration of that study?
Kunal Dhamesha: Dr. Sharvil, one question on Saroglitazar. For the incremental addressable patient pool, one, do we need to do additional studies? If yes, what would be the size, scope, and duration of that study? With, let's say, initial indication we already applied, would we be going for an expedited process here?
Kunal Dhamesha: Dr. Sharvil, one question on Saroglitazar. For the incremental addressable patient pool, one, do we need to do additional studies? If yes, what would be the size, scope, and duration of that study? With, let's say, initial indication we already applied, would we be going for an expedited process here?
Speaker #5: And with, let's say, initial indication, we already applied—would we be going for an expedited process here?
Sharvil Patel: Saro is already being granted priority review by the FDA for its first indication in PBC. That is on track, and as I said, we are building for pre-launch capabilities on that. This will be a continuing trial because we have to follow the patients through and do a rolling phase III. That will continue. We are also adding a marginal ALP trial to Saro for certain patients who have marginal ALP issues. That will also expand the opportunity size of the market, which that trial is about to start. Those are the update on the key trials.
Sharvil Patel: Saro is already being granted priority review by the FDA for its first indication in PBC. That is on track, and as I said, we are building for pre-launch capabilities on that. This will be a continuing trial because we have to follow the patients through and do a rolling phase III. That will continue. We are also adding a marginal ALP trial to Saro for certain patients who have marginal ALP issues. That will also expand the opportunity size of the market, which that trial is about to start. Those are the update on the key trials.
Speaker #2: Saro is already being granted priority review by the SDF for his first indication in PGC, so that is on track. And as I said, we are building pre-launch capabilities for that.
Speaker #2: This will be a continuing trial because we have to follow the patients through and do a rolling Phase 3. So that will continue.
Speaker #2: We are also adding a we are also adding a marginal ELP trial to Saro for certain patients who are marginal ELP issues. So that will also expand the opportunity size of the market.
Speaker #2: That trial is about to start. So, those are the updates on the key trials.
Kunal Dhamesha: The duration, if you could share, there's, let's say, expanded indication. Can it be a near-term opportunity or would take, let's say, two to three years? How should we think about it?
Speaker #5: And the duration, if you could share, like, you know, in, let's say, expanded indication, can it be a near-term opportunity or would it take, let's say, two to three years?
Kunal Dhamesha: The duration, if you could share, there's, let's say, expanded indication. Can it be a near-term opportunity or would take, let's say, two to three years? How should we think about it?
Speaker #5: How should we think about it?
Speaker #2: No, it's not. The expanded indication is not a near-term. It will take two to three years.
Sharvil Patel: No, it's not. The expanded indication is not a near term. It will take 2 to 3 years.
Sharvil Patel: No, it's not. The expanded indication is not a near term. It will take 2 to 3 years.
Speaker #5: Okay, sure. And any update on Uzno Plus for the ALS indication? When is the readout that we expect for that?
Kunal Dhamesha: Okay, sure. Any update on Usnoflast for ALS indication? When is the readout that we expect for that?
Kunal Dhamesha: Okay, sure. Any update on Usnoflast for ALS indication? When is the readout that we expect for that?
Sharvil Patel: Usnoflast, as I said, we have a couple of trials that we are doing. One is a phase II. We initiated a phase II-B in the US for ALS, so that is ongoing. The study is going to enroll 240 patients against a placebo, so that is the way it is moving on. We see it as an FY28 kind of timeline when we can see some data coming out of that. So end of late calendar year 2028 or early 2029. That's when we see the data come out. On the ulcerative colitis trial, we are also looking at that as a potential opportunity also. We are seeing good phase II-A data in India, and we hope to move that obviously in India as the next phase II-B or C, and also potentially evaluate it in the US, which is under evaluation right now.
Speaker #2: No. So Uzno Plus, as I said, we have a couple of trials that we are doing. One is a Phase 2—we initiated a Phase 2 in the US for ALS.
Sharvil Patel: Usnoflast, as I said, we have a couple of trials that we are doing. One is a phase II. We initiated a phase II-B in the US for ALS, so that is ongoing. The study is going to enroll 240 patients against a placebo, so that is the way it is moving on. We see it as an FY 2028 kind of timeline when we can see some data coming out of that. So end of late calendar year 2028 or early 2029. That's when we see the data come out. On the ulcerative colitis trial, we are also looking at that as a potential opportunity also. We are seeing good phase II-A data in India, and we hope to move that obviously in India as the next phase II-B or C, and also potentially evaluate it in the US, which is under evaluation right now.
Speaker #2: So that is ongoing. The study is going to enroll 240 patients against the placebo. So, that is the way it is moving on. Maybe see it as a F528 kind of timeline.
Speaker #2: When we can see some data coming out of that, so end of FY '20, late calendar year '28—'28 or early '29—that's when we will see the data come out.
Speaker #2: On the ulcerative colitis side, we have also been looking at that as a potential opportunity. We have seen good Phase 2a data and we hope, in India, we can move to the next Phase 2b or Phase 3.
Speaker #2: And also potentially evaluate it in the US, which is under evaluation right now.
Kunal Dhamesha: Sure. Thank you.
Kunal Dhamesha: Sure. Thank you.
Speaker #5: Sure. Thank you.
Speaker #1: Thank you. The next question is from Miyanti Care.
Operator 2: Thank you. The next question is from Damayanti Kerai.
Operator: Thank you. The next question is from Damayanti Kerai.
Speaker #3: Yeah. Hi, good afternoon, and thank you for the opportunity. My first question is for Dr. Indicated your medium-term goal—so for these, what kind of spend do you foresee, whether it's towards SG&A or building up the team for specialty, etc.?
Damayanti Kerai: Yeah. Hi, good afternoon and thank you for the opportunity. My first question is for Dr. Sharvil Patel. You indicated your medium-term goal. So, for these, what kind of spend you foresee, whether it is towards the SG&A or building up team for specialty, et cetera.
Damayanti Kerai: Yeah. Hi, good afternoon and thank you for the opportunity. My first question is for Dr. Sharvil Patel. You indicated your medium-term goal. So, for these, what kind of spend you foresee, whether it is towards the SG&A or building up team for specialty, et cetera.
Sharvil Patel: We were not able to hear your question, if you do not mind repeating it, please.
Sharvil Patel: We were not able to hear your question, if you do not mind repeating it, please.
Speaker #2: We were not able to hear your question. If you don't mind, could you please repeat it?
Damayanti Kerai: Yeah, sure. My question was regarding the kind of spend, which you foresee for scaling up some of your newer initiative, whether it is Medtech, specialty, biosimilars. This is also related to how should we see spend required to reach the medium-term goal of getting two-third of revenue from branded products, as you indicated.
Damayanti Kerai: Yeah, sure. My question was regarding the kind of spend, which you foresee for scaling up some of your newer initiative, whether it is Medtech, specialty, biosimilars. This is also related to how should we see spend required to reach the medium-term goal of getting two-third of revenue from branded products, as you indicated.
Speaker #3: Yeah, sure. So my question was regarding the kind of spend which you foresee for scaling up some of your newer initiatives, whether it's med tech, specialty, or biosimilars.
Speaker #3: And this is also related to how we should view the spend required to reach the medium-term goal of getting two-thirds of revenue from branded products, as you indicated.
Speaker #2: So, we have already invested in biologics and vaccines, so that investment has already gone through. Also, MedTech is a business we are running, a growing business which we acquired, and which we have also launched in India.
Sharvil Patel: We have already invested in biologics and REXULTI, so that investment has already gone through. Also, Medtech is a running and growing business which we have, which we acquired, and which we have also launched in India in the cardiovascular side. These businesses are already invested in and are baking into our current margin guidance.
Sharvil Patel: We have already invested in biologics and REXULTI, so that investment has already gone through. Also, Medtech is a running and growing business which we have, which we acquired, and which we have also launched in India in the cardiovascular side. These businesses are already invested in and are baking into our current margin guidance.
Speaker #2: On the cardiovascular side, these businesses are already invested in and are baked into our current margin guidance.
Speaker #3: So, as these businesses scale up and with no major incremental spend, it's safe to assume we will be seeing margins moving up from the level which you indicated for FY27.
Damayanti Kerai: As these businesses scale up and no major incremental spend, it's safe to assume we will be seeing margins moving up from the level which you indicated for FY27?
Damayanti Kerai: As these businesses scale up and no major incremental spend, it's safe to assume we will be seeing margins moving up from the level which you indicated for FY 2027?
Sharvil Patel: FY27, we've guided for a 20,
Sharvil Patel: FY 2027, we've guided for a 20,
Speaker #2: F527 we have added for a 20.
Speaker #3: 24% plus, right?
Damayanti Kerai: 24% plus, right?
Damayanti Kerai: 24% plus, right?
Speaker #2: 24% guidance. So that is what we are sticking to.
Sharvil Patel: 24% margin. That is what we have stick to.
Sharvil Patel: 24% margin. That is what we have stick to.
Speaker #3: Okay. And on the biosimilars, portfolio where you just launched your like big product there. So there also what kind of timeline we should assume to see meaningful sales build up happening?
Damayanti Kerai: Okay. On the biosimilars portfolio where you just launched your big product there, what kind of timeline we should assume to see meaningful sales buildup happening?
Damayanti Kerai: Okay. On the biosimilars portfolio where you just launched your big product there, what kind of timeline we should assume to see meaningful sales buildup happening?
Sharvil Patel: Biosimilars is already a meaningfully scaled business for us and very profitable. It is not a new business for us.
Sharvil Patel: Biosimilars is already a meaningfully scaled business for us and very profitable. It is not a new business for us.
Speaker #2: Biosimilars is already a meaningfully scaled business for us and very profitable. So it is not a new business for us.
Speaker #3: No, I was specifically asking for the US part. India obviously I think you have a very well-established presence. EM as well. But.
Damayanti Kerai: No, I was specifically asking for the US part. India, obviously, I think you have a very well-established presence, EIM as well.
Damayanti Kerai: No, I was specifically asking for the US part. India, obviously, I think you have a very well-established presence, EIM as well.
Speaker #2: Yeah. US is more like a '29 kind of timeline when we will see that business scale up. We will have a couple of products before that.
Sharvil Patel: Yeah, US is more like a 2029 kind of timeline when we will see that business scale up. We will have a couple of products before, but real meaningful scale-up will come in calendar year 2029.
Sharvil Patel: Yeah, US is more like a 2029 kind of timeline when we will see that business scale up. We will have a couple of products before, but real meaningful scale-up will come in calendar year 2029.
Speaker #2: But real meaningful scale up will come in the calendar year 29.
Speaker #3: Okay. That's helpful. Thank you.
Damayanti Kerai: Okay, that's helpful. Thank you.
Damayanti Kerai: Okay, that's helpful. Thank you.
Speaker #1: Thank you. The next question is from Bino.
Arvind Bothra: Thank you. The next question is from Bino.
Operator: Thank you. The next question is from Bino.
[Company Representative] (Elara Capital): Hi. Good evening, all of you. Can you hear me?
Bino Pathiparampil: Hi. Good evening, all of you. Can you hear me?
Speaker #4: Hi, good evening, all of you. Can you hear me? Okay, great. Shervilbhai, I was looking at the US trajectory over the next three to four years.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
[Company Representative] (Elara Capital): Okay, great. Sharvil Patel, I was looking at the US trajectory over the next three, four years. This year we have mirabegron going on, plus fosinopril should come in. Next year also, partly we have mirabegron and palbociclib should come in. But beyond that, do you think there could be a dip in US revenues, even if it is a temporary one?
Bino Pathiparampil: Okay, great. Sharvil Patel, I was looking at the US trajectory over the next three, four years. This year we have mirabegron going on, plus fosinopril should come in. Next year also, partly we have mirabegron and palbociclib should come in. But beyond that, do you think there could be a dip in US revenues, even if it is a temporary one?
Speaker #4: So, this year we have Mirabegron going on, plus Rosiguat should come in. Next year, also, partly we have Mirabegron, and Palbociclib should come in.
Speaker #4: But beyond that, do you think there could be a dip in US revenues, even if it is a temporary one?
Sharvil Patel: No. We still have a growing pipeline of products beyond these valuable products in the market. In fact, we recently also launched mirabegron, where we got 180-day PCT exclusivity. So we have a future pipeline of products which are in the 505(b)(2) and ready-to-use formats and other areas which will all add to meaningful business. We do not see that kind of a fall in the US revenues.
Sharvil Patel: No. We still have a growing pipeline of products beyond these valuable products in the market. In fact, we recently also launched mirabegron, where we got 180-day PCT exclusivity. So we have a future pipeline of products which are in the 505(b)(2) and ready-to-use formats and other areas which will all add to meaningful business. We do not see that kind of a fall in the US revenues.
Speaker #2: No. We currently still have a growing pipeline of products beyond these valuable products in the market. In fact, we also recently launched in this kind of green, where we got 180-day CCT exclusivity.
Speaker #2: So we have a future pipeline of products which are in the 55E2 and ready to use formats and other areas which will all add to meaningful business.
Speaker #2: So, we do not see that kind of a fall in the US revenues.
[Company Representative] (Elara Capital): Understood. Thank you. One bookkeeping question. If I look at the depreciation number, consolidated, it has sharply gone up, starting Q4 of last year, and Q1 also again has gone up. Part of it could be the acquisitions and related amortization. Is there anything else into it? Is this the level at which it will continue?
Bino Pathiparampil: Understood. Thank you. One bookkeeping question. If I look at the depreciation number, consolidated, it has sharply gone up, starting Q4 of last year, and Q1 also again has gone up. Part of it could be the acquisitions and related amortization. Is there anything else into it? Is this the level at which it will continue?
Speaker #4: Understood, thank you. And one bookkeeping question: if I look at the depreciation numbers in Solv data, it has sharply gone up starting Q4 of last year, and in Q1 also, it has gone up again.
Speaker #4: So part of it could be the acquisitions and related amortization. Is there anything else included in it? And is this the level at which it will continue?
Speaker #2: Yeah, so I think largely it is on account of the acquisitions. This amount also includes the licensing amortizations that we had because of the Mirabegron settlement.
Tushar Shroff: Yeah. I think, largely it is on account of the acquisition. This amount also includes the licensing amortizations that we had because of the mirabegron settlement. So that will be up to the first quarter of FY27, FY28.
Tushar Shroff: Yeah. I think, largely it is on account of the acquisition. This amount also includes the licensing amortizations that we had because of the mirabegron settlement. So that will be up to the first quarter of FY 2027, FY 2028.
Speaker #2: So that will be up to the first quarter of FY27-28.
Speaker #4: Do you mind calling out that number, roughly at least?
[Company Representative] (Elara Capital): Do you mind calling out that number?
Bino Pathiparampil: Do you mind calling out that number?
Tushar Shroff: We have not called out that number specifically because of the confidentiality.
Tushar Shroff: We have not called out that number specifically because of the confidentiality.
Speaker #2: We have not called out that number, specifically because of confidentiality.
[Company Representative] (Elara Capital): Okay. Anyway, it will end in Q2 FY28, correct?
Bino Pathiparampil: Okay. Anyway, it will end in Q2 FY 2028, correct?
Speaker #4: Okay. Anyway, it will end in the second quarter of FY28, correct?
Speaker #2: Yes. That's correct.
Tushar Shroff: Yes, that's correct.
Tushar Shroff: Yes, that's correct.
Speaker #4: Okay. Thank you.
[Company Representative] (Elara Capital): Okay. Thank you.
Bino Pathiparampil: Okay. Thank you.
Arvind Bothra: Thank you. The next question is from Saion Mukherjee.
Operator: Thank you. The next question is from Saion Mukherjee.
Speaker #1: Thank you. The next question is from Sayan Mukherjee.
Saion Mukherjee: Yeah, thanks for the follow-up. Just, as you mentioned about the brand part of the business becoming two-thirds or more in the medium term, and this year has been more of an investment year for you. With that business mix changing towards brand from 24% EBITDA margin today, where should you expect, let's say from a FY30 perspective, when you achieve those targets, your EBITDA margin to settle at?
Saion Mukherjee: Yeah, thanks for the follow-up. Just, as you mentioned about the brand part of the business becoming two-thirds or more in the medium term, and this year has been more of an investment year for you. With that business mix changing towards brand from 24% EBITDA margin today, where should you expect, let's say from a FY30 perspective, when you achieve those targets, your EBITDA margin to settle at?
Speaker #5: Yeah, thanks for the follow-up. Just, you know, as you mentioned about the brand part of the business becoming two-thirds or more in the medium term, and this year has been more of an investment year for you.
Speaker #5: So, with that business mix changing towards brand, from a 24% EBITDA margin today, where should we expect, let's say from an FY30 perspective, when you achieve those targets, your EBITDA margin to settle at?
Sharvil Patel: I think from the planning point of view, yes, when we are able to scale up our branded business towards two-thirds, then we should see an improvement in EBITDA margin. Obviously, the first couple of years now you'll see an investment phase on saroglitazar and some of the other portfolio, and also some improvement increase in R&D. But ideally, we would want to be improving our EBITDA margins to the 28%, 30% plus range as we move closer to the five-year period.
Speaker #2: So, I think from the planning point of view, yes. When we are able to scale up our branded business towards the two-thirds mark, then we should see an improvement in EBITDA margins.
Sharvil Patel: I think from the planning point of view, yes, when we are able to scale up our branded business towards two-thirds, then we should see an improvement in EBITDA margin. Obviously, the first couple of years now you'll see an investment phase on saroglitazar and some of the other portfolio, and also some improvement increase in R&D. But ideally, we would want to be improving our EBITDA margins to the 28%, 30% plus range as we move closer to the five-year period.
Speaker #2: Obviously, in the first couple of years, you’ll see an investment phase on Saro and some of the other portfolio segments. And also, some improvement and increase in R&D.
Speaker #2: But ideally, we would want to be improving our EBITDA margins to the 28–30% plus range as we move closer to the five-year period.
Speaker #5: Okay. Thank you.
Saion Mukherjee: Okay, thank you.
Saion Mukherjee: Okay, thank you.
Speaker #1: Thank you. The next question is from Rashmi Shetty.
Arvind Bothra: Thank you. The next question is from Rashmi Shetty.
Operator: Thank you. The next question is from Rashmi Shetty.
Rashmi Sancheti Shetty: Yeah. Thanks for the opportunity. Am I audible?
Rashmi Shetty: Yeah. Thanks for the opportunity. Am I audible?
Speaker #6: Yeah, thanks for the opportunity. Am I audible?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Speaker #6: Yeah, so just one bookkeeping question. On Azure Shio, whatever consideration amount—how are you allocating it? How much are you allocating to Goodwill, intangibles, or anything in gross block?
Rashmi Sancheti Shetty: Yeah. Sir, just one bookkeeping question on Assertio, whatever consideration amount, how much are you allocating to goodwill, intangibles, or anything in gross block?
Rashmi Shetty: Yeah. Sir, just one bookkeeping question on Assertio, whatever consideration amount, how much are you allocating to goodwill, intangibles, or anything in gross block?
Speaker #2: So I think we have a window of 12 months to finalize what should be the purchase price allocation of this entire consideration.
Sharvil Patel: We have a window of 12 months to finalize in terms of what should be the purchase price allocation of this entire consideration. But the large part of this will be towards the brand, as well as the platform that we have got from the commercial platform that we got from this particular acquisition. So large part will be towards intangible.
Sharvil Patel: We have a window of 12 months to finalize in terms of what should be the purchase price allocation of this entire consideration. But the large part of this will be towards the brand, as well as the platform that we have got from the commercial platform that we got from this particular acquisition. So large part will be towards intangible.
Speaker #2: But the large part of this will be towards the brand, as well as the platform that we have got from the commercial platform that we got from this particular acquisition.
Speaker #2: So, a large part will be towards intangible.
Speaker #6: Okay. And amortization and all has not come in in Q1, right, for this quarter?
Rashmi Sancheti Shetty: Okay. Amortization and all has not come in in Q1, right? For this quarter.
Rashmi Shetty: Okay. Amortization and all has not come in in Q1, right? For this quarter.
Speaker #2: Yeah. Yes. That's correct.
Sharvil Patel: Yes, that's correct.
Sharvil Patel: Yes, that's correct.
Speaker #6: Okay. And on your Comfort Click business, how do you see growth for this piece in FY27 and going ahead?
Rashmi Sancheti Shetty: Okay. On your Comfort Click business, how do you see growth for this piece in FY27 and going ahead?
Rashmi Shetty: Okay. On your Comfort Click business, how do you see growth for this piece in FY 2027 and going ahead?
Speaker #2: So we are seeing good, strong, double-digit growth for the business, and in that way we see that happening for this year.
Sharvil Patel: So we are seeing good, strong, double-digit growth for the business, and we see that happen for this year.
Sharvil Patel: So we are seeing good, strong, double-digit growth for the business, and we see that happen for this year.
Speaker #6: Okay, and for the entire consumer business also, you see a strong double-digit growth only, right?
Rashmi Sancheti Shetty: Okay. And for the entire consumer business also, you see a strong double-digit growth only, right?
Rashmi Shetty: Okay. And for the entire consumer business also, you see a strong double-digit growth only, right?
Speaker #2: Yeah, we are looking at double-digit growth.
Sharvil Patel: Yeah, we are looking at a double-digit growth.
Sharvil Patel: Yeah, we are looking at a double-digit growth.
Speaker #6: Okay. And how many launches are planned for the US business for this year?
Rashmi Sancheti Shetty: Okay. And how many launches are planned for the US business for this year?
Rashmi Shetty: Okay. And how many launches are planned for the US business for this year?
Sharvil Patel: Between 30 to 40, depending on multiple scenarios, but at least 30 plus launches.
Sharvil Patel: Between 30 to 40, depending on multiple scenarios, but at least 30 plus launches.
Speaker #2: Between 30 to 40, depending on multiple scenarios. But at least 30-plus launches.
Speaker #6: Okay. And this includes the specialty launches also, right? Hello?
Rashmi Sancheti Shetty: Okay. And this includes the specialty launches also, right? Hello?
Rashmi Shetty: Okay. And this includes the specialty launches also, right? Hello?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Speaker #6: This includes the specialty launches also, right?
Rashmi Sancheti Shetty: This includes the specialty launches also, right?
Rashmi Shetty: This includes the specialty launches also, right?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Speaker #6: Okay, okay. Thank you. That's it from my side.
Rashmi Sancheti Shetty: Okay. Thank you. That is it from my side.
Rashmi Shetty: Okay. Thank you. That is it from my side.
Sharvil Patel: Thank you. The next question is from Surya Patra.
Operator: Thank you. The next question is from Surya Patra.
Speaker #1: Thank you. Thank you. The next question is from Surya Patra.
Speaker #5: Yeah, thanks for the opportunity, sir. Sir, in fact, my first question is about the gross margin. Sorry if I am repeating the question because I joined slightly late.
Surya Narayan Patra: Yeah, thanks for the opportunity, sir. Sir, first question is about the gross margin. Sorry if I am repeating the question because I slightly late join the call. Gross margin this quarter has seen a kind of a dip, both sequentially as well as year-on-year, despite the fact that there would be some currency tailwind that would be there. How should one understand this? Is it entirely due to the kind of a royalty or the commission that we are paying for Mirabegron, or what is the reason that would be?
Surya Patra: Yeah, thanks for the opportunity, sir. Sir, first question is about the gross margin. Sorry if I am repeating the question because I slightly late join the call. Gross margin this quarter has seen a kind of a dip, both sequentially as well as year-on-year, despite the fact that there would be some currency tailwind that would be there. How should one understand this? Is it entirely due to the kind of a royalty or the commission that we are paying for Mirabegron, or what is the reason that would be?
Speaker #5: On the call—see, gross margin this quarter has seen a bit of a dip, both sequentially as well as year over year, despite the fact that there would be some currency tailwind.
Speaker #5: So, how should one understand this? Is it entirely due to a kind of royalty or other commission that we are paying for Mirabegron, or what is the reason for that?
Speaker #2: So, Surya, from a gross margin perspective on a quarter-on-quarter basis, there is—because of this Mirabegron settlement—we had the higher cost associated with that because of the arrangement that we had with the new return.
Sharvil Patel: Surya, on gross margin perspective, on a quarter-on-quarter, because of this Mirabegron settlement, we had the higher cost associated with that because of the arrangement that we had with the innovator. That is impacting on a quarter-on-quarter basis. Yeah.
Sharvil Patel: Surya, on gross margin perspective, on a quarter-on-quarter, because of this Mirabegron settlement, we had the higher cost associated with that because of the arrangement that we had with the innovator. That is impacting on a quarter-on-quarter basis. Yeah.
Speaker #2: So that is impacting on a quarter-on-quarter basis. Yeah.
Speaker #5: Okay. So then, is it fair to believe that, sir? Then, see, this Mirabegron issue would be there in the first half. Second half onwards, it would be subsiding substantially.
Surya Narayan Patra: Okay. Is it fair to believe that, sir, this Mirabegron issue would be there in the H1. H2 onwards, it would be subsiding substantially. Then H2 gross margin scenario will go back to the normalcy situation, excluding for the kind of whatever special situation product opportunity that is there with us. Is that understanding right?
Surya Patra: Okay. Is it fair to believe that, sir, this Mirabegron issue would be there in the H1. H2 onwards, it would be subsiding substantially. Then H2 gross margin scenario will go back to the normalcy situation, excluding for the kind of whatever special situation product opportunity that is there with us. Is that understanding right?
Speaker #5: So then, in the second half, gross margin scenario will go back to the normal situation, excluding any special situation product opportunity that is there with us.
Speaker #5: Is that understanding right?
Speaker #2: No, I think maybe you can contextually think differently. Mirabegron is a very good, profitable driver, so it's not a negative to the business. In fact, in spite of whatever royalty agreements we have, it still has very strong profitability.
Sharvil Patel: No, I think maybe you can contextually think differently. Mirabegron is a very good profitable driver, so it is not a negative to the business. In fact, in spite of whatever royalty agreements we have, it still has very strong profitability. So I would say Mirabegron is not the negative side of the story, but the positive side of the story, because it continues to be semi-exclusive. And in factoring for all of that, we have to guide it for a 24% EPS.
Sharvil Patel: No, I think maybe you can contextually think differently. Mirabegron is a very good profitable driver, so it is not a negative to the business. In fact, in spite of whatever royalty agreements we have, it still has very strong profitability. So I would say Mirabegron is not the negative side of the story, but the positive side of the story, because it continues to be semi-exclusive. And in factoring for all of that, we have to guide it for a 24% EPS.
Speaker #2: So, I wouldn't say Mirabegron is on the negative side of the story, but rather the positive side of the story, because it continues to be semi-exclusive.
Speaker #2: And factoring for all of that, we have to guide for a 24% EBITDA margin.
Speaker #5: Okay. Okay. So kind of a balanced kind of a margin trajectory for the all of the quarter that we are indicating that way. Sure.
Surya Narayan Patra: Okay. So kind of a balanced kind of a margin trajectory for all of the quarter that we are indicating that way. Sure.
Surya Patra: Okay. So kind of a balanced kind of a margin trajectory for all of the quarter that we are indicating that way. Sure.
Sharvil Patel: Yeah. That is what we are guiding for.
Sharvil Patel: Yeah. That is what we are guiding for.
Speaker #2: Yeah, that is what we are guiding for.
Speaker #5: Sure, sir. The second question is about the Saro-Glitter US plans—the launch plans, if you can talk about them—and the associated cost, along with the likely timeline. How should one think about whether it will have an initial cost impact in FY28, or how should one think about it? If you can just elaborate...
Surya Narayan Patra: Sure, sir. Second question is about the Saroglitazar US plans, the launch plans, if you can talk about, and the associated cost, along with that, the likely timeline, what one should think, whether it will kind of have initial cost impact in FY28 or how should one think, if you can just
Surya Patra: Sure, sir. Second question is about the Saroglitazar US plans, the launch plans, if you can talk about, and the associated cost, along with that, the likely timeline, what one should think, whether it will kind of have initial cost impact in FY 2028 or how should one think, if you can just
Speaker #2: So, as I said, Saro is an FY28 launch. So we can give you a better update in the last quarter when we are nearing the launch.
Sharvil Patel: As I said, saroglitazar is an FY28 launch, so we can give you better in the last quarter when we are coming near to launch.
Sharvil Patel: As I said, saroglitazar is an FY 2028 launch, so we can give you better in the last quarter when we are coming near to launch.
Surya Narayan Patra: Okay.
Surya Patra: Okay.
Sharvil Patel: The first two quarters will be a build-out phase for the investment that we make. Even this year and the coming year, we would see uptake in investment and post. That is what we are building for, and that is how we are also guiding in terms of our margins, assuming that there will be investment on saroglitazar.
Sharvil Patel: The first two quarters will be a build-out phase for the investment that we make. Even this year and the coming year, we would see uptake in investment and post. That is what we are building for, and that is how we are also guiding in terms of our margins, assuming that there will be investment on saroglitazar.
Speaker #2: The first two years will be a build-out phase for the investment that we make. So, even this year and the coming year, we would see an uptake in investment.
Speaker #2: And so, that's what we are building for. And that's how we are also guiding in terms of our margins, assuming that there will be investment on Saro.
Speaker #5: Okay. And regards the domestic business piece, see, in fact, as you mentioned in the call itself, that your performance was one of the best in the semaglutade side.
Surya Narayan Patra: Okay. And regards the domestic business piece, sir, see, in fact, as you mentioned in the call itself, that your performance was one of the best in the semaglutide side because of your own brand as well as the kind of a partnership route what you would have adapted. But whether this is a sustainable kind of a trend even in the subsequent quarter, or it is the initial benefit of channel filling and all that, what the street would have seen for everybody. Hence, whether it is a likely sustainable trend, hence the growth in the domestic market should remain elevated and stronger. How should one think about this semaglutide boosting the kind of a growth momentum here in India?
Surya Patra: Okay. And regards the domestic business piece, sir, see, in fact, as you mentioned in the call itself, that your performance was one of the best in the semaglutide side because of your own brand as well as the kind of a partnership route what you would have adapted. But whether this is a sustainable kind of a trend even in the subsequent quarter, or it is the initial benefit of channel filling and all that, what the street would have seen for everybody. Hence, whether it is a likely sustainable trend, hence the growth in the domestic market should remain elevated and stronger. How should one think about this semaglutide boosting the kind of a growth momentum here in India?
Speaker #5: Because of your own brand as well as the kind of a partnership route what you would have adopted. But whether this is a sustainable kind of a trend even in the subsequent quarter or it is the initial benefit of channel filling and all that, what we the street would have seen for everybody.
Speaker #5: So, hence, whether it is a likely sustainable trend, the growth in the domestic market should remain elevated and stronger. How should one think about this semaglutide boosting the kind of growth momentum here in India?
Sharvil Patel: On semaglutide, yes, it is a sustainable momentum, but having said so, our 20% growth is not factored around semaglutide. Semaglutide is a contributor, but a small contributor to that. Our growth has come from our other products rather than semaglutide.
Speaker #2: So, on Sema, yes, it is a sustainable momentum. But having said that, our 20% growth is not factored around Sema. Sema is a contributor, but a small contributor to that.
Sharvil Patel: On semaglutide, yes, it is a sustainable momentum, but having said so, our 20% growth is not factored around semaglutide. Semaglutide is a contributor, but a small contributor to that. Our growth has come from our other products rather than semaglutide.
Speaker #2: Our growth has come from our other products, rather than semaglutide.
Speaker #5: Okay. Just last one point, sir. See, we know that the this year you have mentioned about a kind of a sustaining some single-digit kind of a growth for the US business.
Surya Narayan Patra: Okay. Just last one point, sir. We know that this year you have mentioned about a kind of a sustaining some single-digit kind of a growth for the US business, but because of the mirabegron impact. But going back again to FY28, if we talk about, given the pipeline and given the kind of the Evryanz products exclusivity that is there, again, can we think about double-digit kind of growth in the US business?
Surya Patra: Okay. Just last one point, sir. We know that this year you have mentioned about a kind of a sustaining some single-digit kind of a growth for the US business, but because of the mirabegron impact. But going back again to FY 2028, if we talk about, given the pipeline and given the kind of the Evryanz products exclusivity that is there, again, can we think about double-digit kind of growth in the US business?
Speaker #5: But because of the Mirabegron impact, but going back again to 28, FY 28, if we talk about, given the pipeline and given the kind of the evidence products exclusively that is there, so again, can we think about double-digit kind of growth in the US business?
Speaker #2: I mean, these are all things that we're doing, obviously, on the generic as well as on the branded side, scaling up. So, obviously, we'll see a better profile versus this year.
Sharvil Patel: I mean, there are all things that we are doing with obviously on the generic as well as on the branded side scaling up. So obviously, we will see a better profile this fiscal year.
Sharvil Patel: I mean, there are all things that we are doing with obviously on the generic as well as on the branded side scaling up. So obviously, we will see a better profile this fiscal year.
Speaker #5: Sure. Yeah, yeah, those are the questions, sir. Thanks for taking all my questions.
Surya Narayan Patra: Sure. Yeah. Those are the questions. Thanks for taking all my questions.
Surya Patra: Sure. Yeah. Those are the questions. Thanks for taking all my questions.
Speaker #2: Thank you.
Sharvil Patel: Thanks.
Sharvil Patel: Thanks.
Operator 2: Thank you. The next question is from Vishal Manchanda.
Operator: Thank you. The next question is from Vishal Manchanda.
Speaker #1: Thank you. The next question is from Vishal Manchanda. Hi, thanks for the opportunity. Would you be able to share some color on the Apely Bursep biosimilar launch?
Vishal Manchanda: Hi. Thanks for the opportunity. Would you be able to share some color on aflibercept biosimilar launch? Because you were the first one to launch that in India. Is that shaping up well, and can that be large?
Vishal Manchanda: Hi. Thanks for the opportunity. Would you be able to share some color on aflibercept biosimilar launch? Because you were the first one to launch that in India. Is that shaping up well, and can that be large?
Speaker #1: Because you were the first one to launch that in India. So, is that shaping up well? And can that be large?
Speaker #2: Yeah, I think the initial traction is good for us. We are seeing that it's a very critical product with high-quality specs that are required for this.
Sharvil Patel: Yeah, I think the initial traction is good for us. We are seeing it's a very critical product with high-quality specs that is required for this, and we are seeing good results from the launch of the biosimilar. From the ophthalmology side, this will be a meaningful product for the business.
Sharvil Patel: Yeah, I think the initial traction is good for us. We are seeing it's a very critical product with high-quality specs that is required for this, and we are seeing good results from the launch of the biosimilar. From the ophthalmology side, this will be a meaningful product for the business.
Speaker #2: And we are seeing good results from the launch of the biosimilar. So, from the Sandoz side, this will be a meaningful product for our business.
Vishal Manchanda: That's picking up traction well based on your initial assessments?
Speaker #1: And that's picking up traction well. So based on your initial assessment...
Vishal Manchanda: That's picking up traction well based on your initial assessments?
Speaker #2: Yes.
Sharvil Patel: Yes.
Sharvil Patel: Yes.
Speaker #1: Okay. And I also saw, like, you also in-licensed the innovator product also in the same category. Is that right?
Vishal Manchanda: I also saw you also in-licensed the innovator product also in the same category. Is that right?
Vishal Manchanda: I also saw you also in-licensed the innovator product also in the same category. Is that right?
Speaker #2: Yes. You mean the generic biosimilar of that, right? Yeah, yeah.
Sharvil Patel: You mean the generic biosimilar of that, right? Yeah.
Sharvil Patel: You mean the generic biosimilar of that, right? Yeah.
Vishal Manchanda: No, the innovator brand as well is something you have in-licensed for the. So Eylea, which is the innovator brand, has Zydus in-licensed that as well?
Vishal Manchanda: No, the innovator brand as well is something you have in-licensed for the. So Eylea, which is the innovator brand, has Zydus in-licensed that as well?
Speaker #1: No. The innovator brand as well is something you have in-licensed for, so Eylea, which is the innovator brand. Has Eylea in-licensed that as well?
Sharvil Patel: We've not licensed the innovator brand.
Sharvil Patel: We've not licensed the innovator brand.
Speaker #2: We're not licensed for the innovator brand.
Speaker #1: Okay. Okay. Thank you. That's all from my side.
Vishal Manchanda: Okay. Thank you. That's all from my side.
Vishal Manchanda: Okay. Thank you. That's all from my side.
Speaker #2: Thanks.
Speaker #1: Thank you. We will begin with the Q2 assembly. If anybody wishes to ask a question, please raise your hand from the participant tab on the screen.
Sharvil Patel: Thanks.
Sharvil Patel: Thanks.
Operator 2: We will wait for the queue to assemble. If anybody wishes to ask a question, please raise your hand from the participant tab on the screen. Okay. Thank you very much to Zydus Lifesciences earnings, Zydus Lifesciences management team. Ladies and gentlemen, on behalf of Zydus Lifesciences, that concludes today's conference. Thank you for joining us, and you may now disconnect your line and exit the webinar.
Operator: We will wait for the queue to assemble. If anybody wishes to ask a question, please raise your hand from the participant tab on the screen. Okay. Thank you very much to Zydus Lifesciences earnings, Zydus Lifesciences management team. Ladies and gentlemen, on behalf of Zydus Lifesciences, that concludes today's conference. Thank you for joining us, and you may now disconnect your line and exit the webinar.
Speaker #1: Okay. Thank you very much to Zydus Life Sciences earning Zydus Life Sciences management team. Ladies and gentlemen, on behalf of Zydus Life Sciences, that concludes today's conference.
Speaker #1: Thank you for joining us and you may now disconnect your line and exit the webinar.
Operator 1: Goodbye
