Shilpa Medicare Limited: Q2 FY26 - Scaling New Heights with Innovation and Strategic ExpansionShilpa Medicare Limited, a prominent Indian pharmaceutical company, has reported an exceptional performance for the second quarter of fiscal year 2026 (Q2 FY26), marking a significant milestone with its highest-ever quarterly revenue and EBITDA. The company's consolidated revenue surged by 7% year-on-year to INR 372 crores, while EBITDA witnessed a robust 21% growth, reaching INR 110 crores. This impressive financial trajectory underscores Shilpa Medicare's disciplined execution and strategic focus on complex and differentiated product portfolios. The half-year results further highlight this momentum, with the Profit After Tax (PAT) of INR 91 crores already surpassing the full-year PAT of INR 78 crores for FY25. This strong profitability is complemented by a notable improvement in the adjusted Return on Capital Employed (ROCE), which has risen from 4% in FY23 to approximately 17% in 1HFY26, reflecting enhanced asset utilization and operational efficiency.## Segmental Performance and Growth DriversThe growth in Q2 FY26 was primarily propelled by the strong performance of its core business segments: API and Formulations. The API segment continued to be the largest revenue contributor, generating INR 205 crores and accounting for 55% of the total revenue. This growth was driven by the commercialization of expanded capacities for key products and a robust contribution from both oncology and non-oncology portfolios. The Formulation business also demonstrated healthy growth, contributing INR 139 crores, or 37% of the total revenue. The Biologics segment, while smaller, showed promising traction with INR 25 crores in revenue, representing 7% of the total. The company's gross margins expanded to 72% for the quarter, indicating a favorable product mix and improved operational leverage. The management emphasized that this strong top-line growth and margin expansion are a testament to their strategy of focusing on high-entry-barrier segments and complex product development.### Financial Summary Table| Particulars (INR cr) | 2QFY26 | 2QFY25 | YoY (%) | 1QFY26 | QoQ (%) | 1HFY26 | 1HFY25 | YoY (%) ||--------------------|--------|--------|---------|--------|---------|--------|--------|---------|| Total Revenue | 372 | 349 | 7% | 328 | 13% | 700 | 651 | 8% || Gross Profit | 266 | 227 | 17% | 248 | 7% | 514 | 436 | 18% || EBITDA | 110 | 91 | 21% | 98 | 12% | 208 | 174 | 20% || PAT | 44 | 18 | 144% | 47 | -6% | 91 | 32 | 184% |*All numbers are rounded off to nearest one.## Strategic Initiatives and Future OutlookShilpa Medicare is aggressively pursuing several strategic initiatives to sustain its growth trajectory. A significant highlight is the launch of NODUCATM (norursodeoxycholic acid) in India, a first-in-class therapy for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), previously known as NAFLD. This landmark approval positions Shilpa as the first company globally to introduce this novel bile acid therapy. The company has forged strategic partnerships with three leading Indian companies for marketing and will also launch the brand under its own label, NoducaTM, ensuring robust market penetration. Management anticipates capturing 10-20% of the treated NAFLD population in India over the next 3-5 years, with commercial supplies expected to contribute significantly from the next financial year.Another key development is the successful completion of Phase 3 trials for SMLINJ011, Shilpa's OERIS™ (Ondansetron Extended-Release Injection), a novel once-weekly formulation for Chemotherapy-Induced Nausea and Vomiting (CINV). This innovative product demonstrated superior convenience, strong efficacy, and excellent safety, meeting all primary and secondary endpoints. The company is preparing for regulatory submission to DCGI and plans for global registration via the 505(b)(2) pathway, with launch in India planned for early 2026.In the API segment, Shilpa Medicare has commissioned expanded capacities for high-demand products like UDCA and Tranexamic Acid, with plans for further expansion to meet growing demand. The API business is projected to maintain double-digit year-on-year growth. The Biologics division is also accelerating innovation, with two new Novel Biologic Entities (NBEs) and their first ADC biosimilar advancing towards Phase 1 human studies in FY27. Aflibercept, their most advanced biosimilar, is currently in Phase III studies and is expected to launch in FY27. The Recombinant Human Albumin (rHA) project is progressing well, with a strategic partnership with Orion Corporation for European commercialization and Phase 3 trials set to begin in India and the EU in FY26.### Segmental Revenue Contribution (2QFY26 vs 1HFY26)| Segment | 2QFY26 Revenue (INR cr) | 2QFY26 % | 1HFY26 Revenue (INR cr) | 1HFY26 % ||--------------|-------------------------|----------|-------------------------|----------|| API | 205.0 | 55% | 392.0 | 56% || Formulation | 139.0 | 37% | 238.0 | 34% || Biologicals | 25.0 | 7% | 61.0 | 9% || Others | 3.0 | 1% | 9.0 | 1% |## Outlook and Investor ConfidenceShilpa Medicare's outlook remains optimistic, driven by a clear focus on innovation, strategic expansion, and disciplined capital allocation. The company's management is confident in improving operating leverage and overall ROCE in the coming years, fueled by a better product mix and the successful progression of its Biologics business. The commitment to funding most capex programs through internal accruals and maintaining stable interest outgo further reinforces its financial prudence. Shilpa Medicare is positioning itself as an advanced integrated API, peptide, polymer, differentiated formulation, and biologics and CDMO services company, poised for sustainable and profitable growth in the global pharmaceutical landscape.
Shilpa Medicare reported its highest-ever quarterly revenue of INR 372 crores, a 7% year-on-year increase, and highest-ever EBITDA of INR 110 crores, growing 21% year-on-year. The PAT for the quarter was INR 44 crores, a 144% increase.
NorUDCA (Nor-Ursodeoxycholic Acid) is a novel, first-in-class therapy launched by Shilpa Medicare in India for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Shilpa is the first company globally to launch this product, targeting a large market of 188 million patients in India.
OERIS™ (Ondansetron Extended-Release Injection) is a novel once-weekly injection for Chemotherapy-Induced Nausea and Vomiting (CINV). Positive Phase 3 results show superior convenience and efficacy, targeting a ~USD 375 million global market by improving patient compliance and reducing treatment burden.
The company is commercializing expanded capacities for high-demand API products like UDCA and Tranexamic Acid. It plans to add another 100 metric tons capacity for Tranexamic Acid and expects the API business to continue double-digit year-on-year growth.
The Biologics division is advancing two new Novel Biologic Entities (NBEs) and its first ADC biosimilar towards Phase 1 human studies in FY27. Aflibercept, a major biosimilar, is in Phase III studies and is expected to launch in FY27.
Shilpa Medicare has partnered with Orion Corporation for rHA commercialization in Europe. Phase 3 trials are set to begin in India and the EU in FY26, with a Pre IND filing planned for the US in 2HFY26. The production technology is patented in key developed markets.
Shilpa Medicare plans to fund most of its capex programs through internal accruals, aiming to keep interest outgo stable. The company maintains a healthy Net Debt to EBITDA ratio of 1.4x, reflecting disciplined financial management.
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Shilpa Medicare Limited: Q2 FY26 - Scaling New Heights with Innovation and Strategic ExpansionShilpa Medicare Limited, a prominent Indian pharmaceutical company, has reported an exceptional performance for the second quarter of fiscal year 2026 (Q2 FY26), marking a significant milestone with its highest-ever quarterly revenue and EBITDA. The company's consolidated revenue surged by 7% year-on-year to INR 372 crores, while EBITDA witnessed a robust 21% growth, reaching INR 110 crores. This impressive financial trajectory underscores Shilpa Medicare's disciplined execution and strategic focus on complex and differentiated product portfolios. The half-year results further highlight this momentum, with the Profit After Tax (PAT) of INR 91 crores already surpassing the full-year PAT of INR 78 crores for FY25. This strong profitability is complemented by a notable improvement in the adjusted Return on Capital Employed (ROCE), which has risen from 4% in FY23 to approximately 17% in 1HFY26, reflecting enhanced asset utilization and operational efficiency.## Segmental Performance and Growth DriversThe growth in Q2 FY26 was primarily propelled by the strong performance of its core business segments: API and Formulations. The API segment continued to be the largest revenue contributor, generating INR 205 crores and accounting for 55% of the total revenue. This growth was driven by the commercialization of expanded capacities for key products and a robust contribution from both oncology and non-oncology portfolios. The Formulation business also demonstrated healthy growth, contributing INR 139 crores, or 37% of the total revenue. The Biologics segment, while smaller, showed promising traction with INR 25 crores in revenue, representing 7% of the total. The company's gross margins expanded to 72% for the quarter, indicating a favorable product mix and improved operational leverage. The management emphasized that this strong top-line growth and margin expansion are a testament to their strategy of focusing on high-entry-barrier segments and complex product development.### Financial Summary Table| Particulars (INR cr) | 2QFY26 | 2QFY25 | YoY (%) | 1QFY26 | QoQ (%) | 1HFY26 | 1HFY25 | YoY (%) ||--------------------|--------|--------|---------|--------|---------|--------|--------|---------|| Total Revenue | 372 | 349 | 7% | 328 | 13% | 700 | 651 | 8% || Gross Profit | 266 | 227 | 17% | 248 | 7% | 514 | 436 | 18% || EBITDA | 110 | 91 | 21% | 98 | 12% | 208 | 174 | 20% || PAT | 44 | 18 | 144% | 47 | -6% | 91 | 32 | 184% |*All numbers are rounded off to nearest one.## Strategic Initiatives and Future OutlookShilpa Medicare is aggressively pursuing several strategic initiatives to sustain its growth trajectory. A significant highlight is the launch of NODUCATM (norursodeoxycholic acid) in India, a first-in-class therapy for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), previously known as NAFLD. This landmark approval positions Shilpa as the first company globally to introduce this novel bile acid therapy. The company has forged strategic partnerships with three leading Indian companies for marketing and will also launch the brand under its own label, NoducaTM, ensuring robust market penetration. Management anticipates capturing 10-20% of the treated NAFLD population in India over the next 3-5 years, with commercial supplies expected to contribute significantly from the next financial year.Another key development is the successful completion of Phase 3 trials for SMLINJ011, Shilpa's OERIS™ (Ondansetron Extended-Release Injection), a novel once-weekly formulation for Chemotherapy-Induced Nausea and Vomiting (CINV). This innovative product demonstrated superior convenience, strong efficacy, and excellent safety, meeting all primary and secondary endpoints. The company is preparing for regulatory submission to DCGI and plans for global registration via the 505(b)(2) pathway, with launch in India planned for early 2026.In the API segment, Shilpa Medicare has commissioned expanded capacities for high-demand products like UDCA and Tranexamic Acid, with plans for further expansion to meet growing demand. The API business is projected to maintain double-digit year-on-year growth. The Biologics division is also accelerating innovation, with two new Novel Biologic Entities (NBEs) and their first ADC biosimilar advancing towards Phase 1 human studies in FY27. Aflibercept, their most advanced biosimilar, is currently in Phase III studies and is expected to launch in FY27. The Recombinant Human Albumin (rHA) project is progressing well, with a strategic partnership with Orion Corporation for European commercialization and Phase 3 trials set to begin in India and the EU in FY26.### Segmental Revenue Contribution (2QFY26 vs 1HFY26)| Segment | 2QFY26 Revenue (INR cr) | 2QFY26 % | 1HFY26 Revenue (INR cr) | 1HFY26 % ||--------------|-------------------------|----------|-------------------------|----------|| API | 205.0 | 55% | 392.0 | 56% || Formulation | 139.0 | 37% | 238.0 | 34% || Biologicals | 25.0 | 7% | 61.0 | 9% || Others | 3.0 | 1% | 9.0 | 1% |## Outlook and Investor ConfidenceShilpa Medicare's outlook remains optimistic, driven by a clear focus on innovation, strategic expansion, and disciplined capital allocation. The company's management is confident in improving operating leverage and overall ROCE in the coming years, fueled by a better product mix and the successful progression of its Biologics business. The commitment to funding most capex programs through internal accruals and maintaining stable interest outgo further reinforces its financial prudence. Shilpa Medicare is positioning itself as an advanced integrated API, peptide, polymer, differentiated formulation, and biologics and CDMO services company, poised for sustainable and profitable growth in the global pharmaceutical landscape.