Shilpa Medicare Limited Q3 FY26 Earnings Call Summary

Summary

Shilpa Medicare Limited - Q3 FY26 Earnings Call Summary Friday, February 6, 2026, 16:00 hrs

Event Participants

Executives 3 Alpesh Dalal (CFO), Keshav Bhutada (ED & CEO, Shilpa Pharma Lifesciences), Monish Shah (Head, IR and Strategy)

Analysts 6 Amish Kanani, Kiran, Krisha Kansara, Nikhil, Sanjay Kumar, Shubham Sehgal

Financials & KPIs

Geographic & Segment Commentary

• Europe: Revenue reached ₹73 crores for the quarter, growing over 100% YoY. Growth is fueled by Nilotinib, where the company maintains a strong market share through its partnership with a leading generic firm, despite the innovator still holding 40% of the market.
• Domestic Formulation: Launched NorUDCA (NorUrsodeoxycholic acid) for NAFLD, exceeding expectations with a strong order book for Q4. The product is marketed under an in-house label and through partnerships with three large Indian pharma companies.
• CDMO (API & Biologics): Added three new CDMO programs in API; one U.S. NCE program commercialized by a partner, with another expected in FY27. In Biologics, five active programs are ongoing, with two entering Phase I human studies in FY27.

Company-Specific & Strategic Commentary

• Peptide Expansion: Initiated a ₹40 crore capex for a dedicated peptide facility to target GLP-1 blockbusters (Semaglutide/Liraglutide) with capacity exceeding 100 kgs; completion expected in H2 FY27.
• Biologics & ADC: Commissioning India’s first integrated ADC (Antibody Drug Conjugate) facility in Q4 FY26. First ADC product (SBPL01) to enter human studies in FY27.
• NorUDCA Global Strategy: Planning human studies in Europe and U.S. filings for new indications in FY27; the product targets the NAFLD market which impacts ~25% of the Indian population.
• Transdermal & Injectables: Received EMA approval for Rotigotine patch with launch slated for Q1 FY27; Ondansetron long-acting injection Phase III completed in India with H1 FY27 launch target.

Guidance & Outlook

Risks & Constraints

Q&A Highlights

Nilotinib Performance & Competition

• Question: What is the growth driver for EU sales and is there new competition? (Krisha Kansara)
• Answer: Growth is volume-driven; innovator still holds 40% market share. No significant new generic competition seen yet; partnering with the #1 generic player in Europe provides a competitive moat (Keshav Bhutada).

API Growth Drivers

• Question: Why has the non-captive API segment been stagnant? (Krisha Kansara)
• Answer: API resources were deliberately shifted to support high-margin captive formulation launches. Expect external revenue ramp-up from Q2 FY27 as new non-onco capacities are utilized (Keshav Bhutada, Alpesh Dalal).

Biologics Strategy

• Question: Will Biologics like Nivo and Pembro be for India only? (Sanjay Kumar)
• Answer: No, the strategy is global. Major partnerships for global markets are expected to be signed in FY27 (Keshav Bhutada).

Peptide Capex Rationale

• Question: What is the scale and reason for the new ₹40 crore peptide investment? (Sanjay Kumar)
• Answer: Targeting the global GLP-1 patent cliff in the next 2-3 years. Facility will produce over 100kg+ of products like Semaglutide for both in-house use and CDMO (Keshav Bhutada).

Key Takeaway

Shilpa Medicare reported its highest-ever quarterly revenue of ₹411 crores (+28% YoY) and EBITDA of ₹115 crores, signaling a transition from a heavy investment phase to an execution cycle. Performance was primarily driven by the Formulation business, particularly European sales of Nilotinib and the successful domestic launch of NorUDCA. The company is strategically pivots toward high-value segments including GLP-1 peptides (₹40 crore capex), ADCs, and biosimilars like Aflibercept and Albumin. While the core API business grew 11% (including captive), the focus remains on integrated CDMO and 505(b)(2) filings. Management expects to maintain a steady ₹150 crore annual licensing income and anticipates further margin expansion as Biologics enter clinical milestones. Investors should monitor the U.S. FDA remediation status at Jadcherla and the progress of global clinical trials for Albumin in FY27.