Wockhardt Limited announced on May 30, 2026, that it has received approval from the U.S. Food and Drug Administration (FDA) for ZAYNICH™ (cefepime and zidebactam). This novel intravenous antibiotic is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. This approval marks a significant milestone as ZAYNICH™ is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval.

Clinical Efficacy and Trial Results

The FDA approval was based on the results of the Phase 3 ENHANCE-1 clinical trial. ZAYNICH™ demonstrated superior efficacy compared to meropenem, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem. The treatment difference was 20.6% (95% CI; 12.3, 29.5). The randomized, double-blind, multicenter study enrolled 530 patients across 64 sites in the U.S., Europe, LATAM, China, and India. The drug was generally well tolerated during the study.

Mechanism of Action and Designations

ZAYNICH™ is a multi-penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam. Unlike most other beta-lactam combinations, it targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. This mechanism provides bactericidal activity against challenging drug-resistant Gram-negative bacteria. The drug previously received Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations from the FDA.

Regulatory and Strategic Milestones

Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group, highlighted that this approval represents a historic milestone for the Indian pharmaceutical industry. Prior to the U.S. approval, ZAYNICH™ was approved by the Drugs Controller General of India (DCGI) on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency. The company currently has a pipeline of six antibiotics, all granted QIDP designation by the U.S. FDA.

Wockhardt Limited 's Board of Directors, at its meeting held on May 4, 2026, approved the audited standalone and consolidated financial results for the quarter and year ended March 31, 2026, pursuant to Regulation 30 and 33 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The statutory auditors, M/s. M S K C & Associates LLP, issued an unmodified audit opinion on both the standalone and consolidated financial results. The board meeting commenced at 11:00 a.m. and concluded at 3:10 p.m.

Standalone Financial Performance

Wockhardt reported a strong turnaround in its standalone financials for FY26. The company swung to a net profit of ₹317 Crore for the year ended March 31, 2026, compared to a net loss of ₹12 Crore in the prior year. Revenue from operations grew to ₹1,739 Crore from ₹1,402 Crore. The following table summarises the key standalone financial metrics:

*not annualised; face value of ₹5/- each

On the standalone balance sheet, total assets stood at ₹5,935 Crore as at March 31, 2026, compared to ₹5,408 Crore in the prior year. Total equity increased to ₹3,084 Crore from ₹2,763 Crore, with other equity rising to ₹3,003 Crore from ₹2,682 Crore. Standalone cash and cash equivalents at the end of the year stood at ₹76 Crore, up from ₹35 Crore at the beginning of the year, with net cash inflow from operating activities of ₹241 Crore for FY26 against a net outflow of ₹14 Crore in FY25.

Consolidated Financial Performance

On a consolidated basis, Wockhardt's group revenue from operations grew to ₹3,373 Crore in FY26 from ₹3,012 Crore in FY25. Total consolidated income for FY26 stood at ₹3,484 Crore compared to ₹3,074 Crore in the prior year. The group reported a net profit after tax of ₹199 Crore for FY26, reversing a net loss of ₹57 Crore in FY25. Net profit attributable to equity shareholders of the company was ₹213 Crore for FY26, compared to a loss of ₹47 Crore in FY25.

*not annualised; face value of ₹5/- each

Consolidated total assets as at March 31, 2026 stood at ₹8,615 Crore against ₹8,135 Crore in the prior year. Total consolidated equity increased to ₹5,281 Crore from ₹4,657 Crore. Consolidated cash and cash equivalents at the end of the year were ₹217 Crore, up from ₹112 Crore, with net cash inflow from operating activities of ₹390 Crore for FY26 against a net outflow of ₹22 Crore in FY25.

Q4 EBITDA Performance

Wockhardt's operational profitability showed a marked improvement in Q4, with consolidated EBITDA and margin expanding significantly on a year-on-year basis. The table below highlights the key Q4 EBITDA metrics:

Exceptional Items

Several exceptional items impacted the financial results for FY26. The key items are summarised below:

• Settlement with Dr. Reddy's Laboratories: Wockhardt had previously concluded a Business Transfer Agreement ("BTA") with Dr. Reddy's Laboratories Limited on February 12, 2020, for the transfer of a portion of its Domestic Branded Division, with total consideration of ₹1,850 Crores, of which ₹300 Crores was designated as a "Holdback Amount." The company entered into a full and final settlement of all claims and disputes under the BTA effective March 31, 2026, recognising a net gain of ₹35 Crore under Exceptional Items for the quarter ended March 31, 2026.
• Deconsolidation of US Subsidiaries (Consolidated): The group decided to exit the US generic pharmaceutical business and filed for voluntary liquidation on July 11, 2025 under Chapter 7 of the US Bankruptcy Code for its US step-down subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC. The group recognised an initial charge of ₹97 Crores under Exceptional Items for the quarter ended September 30, 2025. During the quarter ended March 31, 2026, the group executed a settlement agreement with the Chapter 7 trustee, resulting in a net additional charge of ₹13 Crores. The total consolidated exceptional items for FY26 amount to a net charge of ₹85 Crores.
• Impact of New Labour Codes: Effective November 21, 2025, the Government of India consolidated multiple existing labour legislations into four Labour Codes. The company assessed and accounted for the incremental impact based on actuarial valuation, amounting to ₹10 Crores as an Exceptional Item.

Fund Raising Proposal and Other Developments

The Board also approved an enabling proposal for raising funds through the issue of equity shares, securities convertible into equity shares, non-convertible securities, or any combination thereof, through public or private offerings, Qualified Institutions Placement, preferential allotment, or any other permissible method, in one or more tranches. This proposal is subject to the consent of shareholders at the ensuing Annual General Meeting and such other approvals and compliances as may be required. The consolidated results encompass Wockhardt Limited and 31 subsidiaries, with the group operating exclusively in the pharmaceutical business segment.

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