Biocon Pharma Limited, a subsidiary of Biocon Limited, announced on May 11, 2026, that it has received approval from Health Canada for micafungin for injection, USP, 50 mg and 100 mg. The development was disclosed to stock exchanges under Regulation 30 and marks a significant regulatory milestone for the company's generics business in Canada.

Approval Details

The Health Canada approval covers micafungin for injection in two strengths. The key details of the approved product are outlined below:

Indications and Patient Population

The approved product is indicated for use in adults and children four months and older. The approval encompasses the following therapeutic indications:

• Treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses infections
• Treatment of patients with esophageal candidiasis
• Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation

Portfolio Strengthening

According to the company statement, this approval will further strengthen Biocon's integrated biosimilars and generics portfolio. The regulatory clearance from Health Canada represents an addition to the company's product offerings in the Canadian market. The announcement was made by Rajesh U. Shanoy, Company Secretary and Compliance Officer of Biocon Limited, and communicated to both BSE Limited and the National Stock Exchange of India Limited on May 11, 2026.

Biocon Limited, an innovation-led global biopharmaceuticals company, announced its consolidated financial results for the fiscal fourth quarter and the full financial year ended March 31, 2026. The company delivered broad-based revenue growth across its business segments, with notable margin expansion on a like-to-like basis, as it completed the integration of its biosimilars and generics businesses into a single unified biopharmaceutical enterprise. The Board of Directors, at its meeting held on May 07, 2026, also approved a series of significant corporate actions alongside the financial results.

Q4FY26 Financial Performance

For the quarter ended March 31, 2026, Biocon posted Total Income of Rs 4,569 Cr, up 10% YoY after adjusting for one-time generic Lenalidomide sales in Q4FY25. Operating Revenue stood at Rs 4,517 Cr, also up 10% YoY on the same adjusted basis. EBITDA came in at Rs 1,073 Cr, with an EBITDA margin of 23% compared to 25% in Q4FY25 (reported). Net Profit (reported) for the quarter stood at Rs 126 Cr versus Rs 344 Cr in Q4FY25, while Net Profit before exceptional items was Rs 179 Cr, up 64% YoY on an adjusted basis. Net R&D Investment for the quarter stood at Rs 277 Cr, representing 8% of revenue (excluding Syngene).

The following table summarises the key consolidated financial metrics for Q4FY26 versus Q4FY25:

Adjusted figures exclude one-time generic Lenalidomide sales in Q4FY25. Exceptional items during Q4FY26 amounted to Rs (80) Cr.

FY26 Full-Year Financial Performance

For the full financial year FY26, Biocon reported Total Income of Rs 17,270 Cr, up 14% on an adjusted basis (excluding one-time generic Lenalidomide sales in Q4FY25 and adjusted for BFI divestment gain). Operating Revenue for FY26 stood at Rs 16,927 Cr, up 13% YoY on an adjusted basis. EBITDA for the year was Rs 3,798 Cr, up 25% YoY (adjusted), with an EBITDA margin of 22%, representing approximately 200 basis points of expansion on a like-to-like basis. Net Profit before exceptional items reached Rs 436 Cr, up 323% YoY on an adjusted basis. Net R&D Investment for the year was Rs 982 Cr, representing 8% of revenue (excluding Syngene).

Adjusted figures exclude one-time generic Lenalidomide sales in Q4FY25 and are adjusted for BFI divestment gain. Exceptional items during FY26 amounted to Rs (403) Cr.

Segment-Wise Performance

The Biosimilars segment remained the core growth driver, contributing 60% of revenue from operations, followed by Research Services (CRDMO/Syngene) at 22% and Generics at 18%. The following table presents segment-wise revenue for both Q4FY26 and FY26:

Biosimilars: Q4FY26 EBITDA stood at Rs 720 Cr, up 33% YoY, with an EBITDA margin of 26%. For FY26, EBITDA grew 40% YoY on a like-to-like basis, also at a margin of 26%. The company launched Bosaya™ and Aukelso™, the Denosumab biosimilars to Prolia® and Xgeva®, in the U.S., and received Health Canada approvals for Denosumab biosimilars Bosaya™ and Vevzuo™. The segment served 6.5+ million patients on a moving annual total basis (April 2025 to March 2026).

Generics: Q4FY26 EBITDA stood at Rs 75 Cr, with an EBITDA margin of 8%, improving approximately 300 basis points QoQ, driven by higher volumes and operating leverage. Growth in the quarter was supported by generic Liraglutide sales in Europe. The company also secured U.S. FDA approval for generic Liraglutide covering both diabetes and weight management indications during the quarter.

CRDMO – Syngene: Q4FY26 operating revenue at Rs 1,037 Cr was up 2% YoY and 13% QoQ. For FY26, Syngene's operating revenue grew 3% YoY to Rs 3,739 Cr, with an EBITDA margin of 25%, in line with revised full-year guidance. Syngene completed 14 client and regulatory audits during Q4FY26, bringing the full-year total to 85.

Leadership Commentary

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Limited, stated: "Biocon closed FY26 on a strong note despite a complex geopolitical environment. We delivered margin expansion along with 13% YoY growth in operating revenue, excluding the one-time impact of generic lenalidomide sales last year. This performance reflects the resilience of our business and disciplined execution through a pivotal year of integration. We have created a unified biopharma entity by integrating biosimilars business with generics formulations and APIs business. The combined business has a stronger balance sheet, improved leverage metrics and a more global commercial footprint. We are now focused on profitability enhancement and long-term value creation."

Shreehas Tambe, CEO & Managing Director, Biocon Limited, noted: "FY26 was a pivotal year for Biocon, marked by the successful integration of our biosimilars and generics business to create one unified biopharmaceutical enterprise with greater scale, capability, and reach. Even as we integrated the businesses, Biocon delivered ~200 basis points of EBITDA margin expansion at a consolidated level on a like-to-like basis, driven by an improved product mix and operational excellence. Our biosimilars business recorded 16% YoY growth in revenue and 40% increase in EBITDA, on a like-to-like basis. Growth was led by strong performance in advanced markets and key tender wins across emerging markets. With the integration now complete, we shift gears in fiscal 2027 from the 'Preserve' phase of our strategy to 'Consolidate', as we set up the business for sustainable growth."

Peter Bains, CEO & Managing Director, Syngene International Limited, commented: "Syngene's full-year revenue from operations grew 3%, and with an EBITDA margin of 25%, performance was in line with our revised full-year guidance. The overall numbers reflect the specific impact from a single large-molecule biologics client, with the underlying business showing steady momentum. During the year, we continued to invest in new capabilities and emerging modalities such as peptides and ADCs, further strengthening our integrated offering and positioning us for long-term growth."

Corporate Developments

Dividend: The Board of Directors has recommended a final dividend of Re. 0.50 per share at the rate of 10% of the face value of the share for the financial year ending March 31, 2026. The record date for determining entitlement of shareholders has been fixed as Friday, July 03, 2026, and the dividend will be paid on or before August 31, 2026.

Acquisition of Biocon Biologics Limited (BBL) Equity: The Board approved the acquisition of the remaining ~2% of BBL's paid-up equity share capital on a fully diluted basis from employees and other shareholders of BBL through a share swap. The consideration will be discharged by issuance of up to 87,92,317 equity shares of the Company on a preferential basis at an issue price of Rs. 376.16 per share, aggregating up to Rs. 330.73 Crores. Additionally, the Board approved the conversion of 1,125 Optionally Convertible Debentures (OCDs) of BBL into 4,11,11,689 equity shares of BBL, and the conversion of 1,06,86,044 Compulsorily Convertible Debentures (CCDs) of BBL into 1,06,86,044 equity shares of BBL. Post completion of these transactions, Biocon shall hold ~99.99% of BBL's paid-up equity share capital on a fully diluted basis. The acquisition of equity shares is expected to be completed on or before June 30, 2026, subject to shareholder and regulatory approvals.

The following table summarises the key parameters of the BBL acquisition and preferential issue:

Change in Statutory Auditors: The Board recommended for shareholder approval the appointment of M/s. S. R. Batliboi & Associates LLP, Chartered Accountants (Firm Registration No. 101049W/E300004), as Statutory Auditors for a term of 5 consecutive years from the conclusion of the ensuing 48th AGM till the conclusion of the 53rd AGM to be held in the year 2031, in place of the retiring auditors M/s. B S R & Co. LLP.

Long-Term Incentive Plan: The Board approved the formulation and implementation of the Biocon Unity Long Term Incentive Plan 2026, comprising the Biocon Limited Performance Stock Unit Plan 2026, Restricted Stock Unit Plan 2026, Employee Stock Purchase Plan 2026, and Management Stock Unit Plan 2026, subject to shareholder approval.

Annual General Meeting: The 48th AGM of the Members of the Company will be held on Thursday, August 06, 2026, through Video Conferencing/Other Audio-Visual Means.

Board Updates: The Board has recommended for shareholder approval the appointment of Rajiv Malik, Daniel Bradbury, Peter Piot, Arun Chandavarkar, and Nivruti Rai as Independent Directors, each with effect from August 1, 2026, until the conclusion of the Company's 50th AGM to be held in the year 2028. Thomas Roberts has been recommended as a Non-Executive, Non-Independent Director with effect from August 1, 2026. Ms. Rekha Mehrotra Menon has been recommended for re-appointment as an Independent Director for a second term of 5 consecutive years commencing from August 06, 2026 till August 05, 2031.

Management Updates: Shreehas Tambe took charge as CEO & Managing Director of Biocon Limited on April 1, 2026, with Kedar Upadhye appointed as Chief Financial Officer. The Board also approved the designation of Dr. Anuj Goel as Chief Development Officer and Mr. Susheel Umesh as Chief Commercial Officer – Emerging Markets and Head of Global API & Global BD, as Senior Management Personnel of the Company with immediate effect.

Awards, Recognitions, and ESG

During the period, Biocon and its leadership received several recognitions:

• Kiran Mazumdar-Shaw conferred Honorary Doctor of Philosophy in Applied Life Sciences by the Keck Graduate Institute
• Kiran Mazumdar-Shaw received an Honorary Fellowship of the UK Academy of Medical Sciences
• Kiran Mazumdar-Shaw conferred with SAHIT Global Icon Award
• Shreehas Tambe recognized as one of the Most Promising Business Leaders of Asia 2026

On the sustainability front:

• Biocon included in the S&P Global Sustainability Yearbook 2026 for the fourth consecutive year
• Biocon ranked among Businessworld's Top 20 Most Sustainable Companies in India, securing 3rd position in the pharma sector
• Syngene included in the S&P Global Sustainability Yearbook 2026 and recognized as an 'Industry Mover'

Earnings Call Recording

Pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, Biocon has made available the audio and video recording of its Q4 FY26 Earnings Call conducted on May 08, 2026. The recording is accessible via the company's investor relations page at www.biocon.com .