Biocon Ltd

Regulatory approval in Japan

• Biocon Biologics Ltd. received MHLW marketing approval for pegfilgrastim biosimilar in Japan.
• Global Regulatory Partners Japan serves as the MAH for Biocon's biosimilar.
• Sandoz K.K. will exclusively promote, sell, and distribute the product in Japan.
• There are no disclosed revenue figures or financial impacts yet.
• Product is a Neulasta® biosimilar developed by Biocon Biologics Ltd.

FDA approvals

• US FDA granted supplemental approval for Yesintek 45 mg/0.5 ml single-dose autoinjector.
• US FDA also approved Yesintek 90 mg/ml single-dose autoinjector.
• Yesintek was originally approved by FDA on November 29, 2024.
• The new delivery format expands options for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
• Regulatory approval reinforces Biocon's immunology portfolio in the United States.
• No revenue or financial metrics disclosed in this filing.

Meeting Details

• Date: 17-Aug-2026; Time: not specified; Interaction: 1x1/Group/In-Person.
• Event: Motilal Oswal 22nd Annual Global Investor Conference, Mumbai.
• Purpose: meetings with analysts and institutional investors.
• Availability: information will be posted on Biocon's website.

Financial Highlights

• Q1 FY27: group operating revenue up 10% YoY.
• Biosimilars revenue INR 2,855 crores, +16% YoY.
• Biosimilars EBITDA INR 728 crores, margin 25%.
• Services revenue declined 16% YoY.
• Group EBITDA INR 902 crores, margin 21%.
• Interest cost declined 23% YoY to INR 213 crores.
• Net profit before exceptionals INR 145 crores, +245% YoY.
• R&D at 7% of biosimilars revenue.

Biosimilars Update

• Q1 biosimilars revenue INR 2,855 crores, +16% YoY.
• EBITDA INR 728 crores; margin 25%.
• R&D expense 7% of biosimilars revenue.
• EMA approved second drug product line at Malaysia insulin facility; supplies started.
• Second insulin line to support growth; ramp-up in Q2 FY27.
• North America drives biosimilars growth.
• Yesafili launched; first approved aflibercept biosimilar in Malaysia.
• Aflibercept biosimilar launch in US ophthalmology; initial contracting.

Generics Update

• Generics revenue INR 760 crores; +21% YoY.
• EBITDA INR 56 crores; margin 7%.
• GLP-1 liraglutide contributes to growth across markets.
• Integration-led opex reductions support EBITDA expansion.
• New launches to scale up; opex productivity remains strong.

Services Update

• Syngene Q1 FY27 revenue INR 736 crores; -16% YoY.
• Operating EBITDA margin 12%.
• Forex hedge loss partly offset by cost optimization.
• FY27 transition year; 1H decline; 2H recovery; single-digit revenue degrowth.
• BRIC-THSTI collaboration; SynAI platform expansion.
• Return to mid-20s EBITDA margins from FY28.

Debt and Capital

• Net debt up ~INR 1,100 crores sequentially.
• Inventory and receivables rose ahead of second-half scale-up.
• Days of inventory outstanding ~280–290; DIO improving.
• Interest cost down 23% YoY to INR 213 crores.
• No US capex increase; prefer partnerships; local footprint as needed.
• Malaysia insulin line commissioned; no immediate US capex.

Outlook and Guidance

• Second half FY27 expected to be stronger than the first half.
• Biosimilars margins guided to mid-20s; growth from new launches.
• Syngene FY27 EBITDA margins expected to return to mid-20s.
• Aflibercept ramp expected to contribute in the second half.

Q&A Highlights

• Q: Base generics growth ex-liraglutide; A: opex reductions and integration savings support profitability.
• Q: Biosimilars margin improvement; A: margins expected mid-20s.
• Q: Aflibercept ramp; A: strong second-half start; contracts in place.
• Q: US capex stance; A: no increase; partnerships preferred.
• Q: Tariffs risk; A: exemptions for generics/biosimilars; Biocon watching.
• Q: Bicara stake; A: small; monetization not planned.
• Q: Syngene impact; A: Biocon core growth powered by biosimilars.

AGM Details

• AGM held on 06 Aug 2026 at 3:30 PM IST via video conferencing.
• Record date for voting rights: 30 Jul 2026.

Dividend

• Final dividend of 10% (₹0.50 per share) approved.

Key Resolutions and Outcomes

• Resolution 1 (Ordinary): Adopt audited financial statements; 99.99% in favour.
• Resolution 2 (Ordinary): Declare final dividend; 99.99% in favour.
• Resolution 3 (Ordinary): Appoint Eric Vivek Mazumdar as Director by rotation; 99.52% in favour.
• Resolution 4 (Ordinary): Appoint S.R. Batliboi & Associates LLP as Statutory Auditors; 99.51% in favour.
• Resolution 5 (Special): Approve Biocon Unity LTIP 2026 and related plans; 79.89% in favour.
• Resolution 6 (Special): Grant LTIP incentives to eligible employees; 79.89% in favour.
• Resolution 7 (Special): Authorization to Biocon India Ltd Employees Welfare Trust for secondary acquisition; 80.06% in favour.
• Resolution 8 (Special): Provide financial assistance to the Trust for LTIP implementation; 80.06% in favour.
• Resolution 9 (Ordinary): Ratify remuneration of Cost Auditors for 2026-27; 99.99% in favour.

Director Changes

• Director: Eric Vivek Mazumdar re-appointment by rotation; eligible for re-appointment.

Auditor Appointments

• Statutory Auditors: S.R. Batliboi & Associates LLP appointed; tenure as statutory auditors indicated.

Meeting Details

• Date: 12-Aug-2026; time not disclosed.
• Event: EmkayConfluence 2026 (group investor meet).
• Type/Mode: Group interaction; virtual.
• Venue: Virtual conference.

Participants

• Company management to participate (roles not disclosed).

Purpose

• Purpose: investor interaction with analysts/institutional investors.

Availability

• Information will be available on Biocon website.

Director and Auditor changes

• Re-appointment of Eric Vivek Mazumdar as Director liable to retire by rotation; effective August 6, 2026.
• Relationship disclosed: Mazumdar is related to Biocon promoter family (son of Ravi Mazumdar; nephew of Kiran Mazumdar-Shaw).
• Retiring Statutory Auditors B S R & Co. LLP; term expired at conclusion of the 48th AGM.
• S.R. Batliboi & Associates LLP appointed Statutory Auditors for five years from 48th AGM to 53rd AGM (2031).
• Independent Director Nicholas Haggar to retire upon completion of his term.