Glenmark Pharmaceuticals Ltd. , a global pharmaceutical company, has announced its financial results for the first quarter of fiscal year 2026 (Q1 FY26) while also providing an optimistic outlook for its European and emerging markets business.

Growth Forecast for Europe and Emerging Markets

Glenmark Pharma anticipates strong double-digit growth in its Europe and emerging markets region starting from the second quarter of FY26. This positive outlook comes as the company aims to capitalize on its expanding presence in these geographical segments.

Q1 FY26 Financial Highlights

For the quarter ended June 30, 2025, Glenmark reported the following key financial metrics:

• Consolidated revenue: Rs. 32,644.00 Mn, a slight increase of 0.60% year-over-year (YoY)
• EBITDA: Rs. 5,805.00 Mn, with an EBITDA margin of 17.80%
• Adjusted Profit After Tax: Rs. 3,129.00 Mn, with an adjusted PAT margin of 9.60%

Performance Across Key Markets

Management Commentary

Glenn Saldanha, Chairman & Managing Director of Glenmark Pharmaceuticals Ltd., commented on the results: "In Q1FY26, our U.S. business delivered QoQ growth, driven by a combination of injectable and partnered products launches. Our Europe and Emerging markets businesses have recorded >25% CAGR and >10% CAGR respectively over the last three years, and we expect the region to deliver a double-digit growth from the second quarter onwards."

Strategic Developments

• The company's recent IGI-AbbVie global licensing agreement for ISB 2001 has been highlighted as a strong validation of Glenmark's innovation capabilities.
• Glenmark's strategy focuses on driving growth across markets while advancing branded, specialty, and innovative products.

Exceptional Item

The company reported an exceptional item related to a settlement in an antitrust lawsuit in the United States. Glenmark has agreed to settle with the putative direct purchaser class for a total of US$ 37.75 million, subject to court approval. This settlement amount has been provisioned in the Q1 FY26 results.

Outlook

Glenmark remains confident in its strategy to drive growth across its markets, with a particular focus on the promising outlook for its European and emerging markets businesses. The company continues to advance its branded, specialty, and innovative products portfolio to deliver long-term value for stakeholders.

As Glenmark Pharmaceuticals navigates the evolving pharmaceutical landscape, its diversified geographical presence and focus on innovation are expected to play crucial roles in its future growth trajectory.

Glenmark Pharmaceuticals , a leading Indian pharmaceutical company, finds itself navigating regulatory challenges while simultaneously receiving positive financial outlook revisions. The company's stock performance remains resilient despite recent regulatory setbacks.

FDA Issues Warning Letter

The US Food and Drug Administration (FDA) has issued a Warning Letter to Glenmark Pharmaceuticals for its Pithampur manufacturing facility following an inspection. The agency found that the facility's methods, controls, and operations failed to comply with Current Good Manufacturing Practice (CGMP) regulations.

Key issues flagged by the FDA include:

• Inadequate investigations into dissolution failures in potassium chloride extended-release capsules and another product
• Insufficient scientific justification in the company's responses
• Concerns over delayed stability testing, resulting in late detection of product failures and subsequent delays in initiating recalls and issuing field alerts

This marks Glenmark's fourth FDA warning letter, following previous warnings issued to its facilities in Himachal Pradesh, Goa, and North Carolina.

Recommendations and Company Response

The FDA has recommended that Glenmark engage a qualified CGMP consultant and undertake a comprehensive review of its global quality systems. The company is expected to address these concerns promptly to ensure compliance with regulatory standards.

Positive Credit Outlook

Despite the regulatory challenges, India Ratings and Research (Ind-Ra) has revised the outlook on Glenmark Pharmaceuticals' long-term bank facilities to Positive from Stable while affirming the ratings at 'IND AA'. This revision reflects expectations of improved revenue visibility for Ichnos Glenmark Innovation (IGI), a 100% subsidiary of Glenmark.

The positive outlook is primarily driven by:

• An exclusive global licensing agreement between IGI and AbbVie Inc. for the lead investigational asset, ISB 2001 molecule
• Potential for significant financial gains, including an upfront payment of $700.00 million and eligibility for up to $1225.00 million in milestone payments
• Tiered, double-digit royalties on net sales

Financial Performance

Glenmark's financial performance has shown improvement:

• Consolidated revenue grew 12.80% year-on-year to ₹133.20 billion
• EBITDA margin expanded by 753 basis points to 17.70%
• Strong performance in the India formulations business, with 31.90% year-on-year growth

Market Performance

Despite the regulatory challenges, Glenmark shares were trading 0.48% higher at ₹2149.00. The stock has gained 33.00%, indicating investor confidence in the company's overall prospects.

Future Outlook

While Glenmark faces regulatory hurdles, particularly in its US operations, the company's strong position in the Indian market and positive financial outlook present a mixed picture. The management expects 12.00%-14.00% year-on-year revenue growth with an EBITDA margin of up to 23.00% over the medium term.

As Glenmark works to address the FDA's concerns and capitalize on its strategic partnerships, investors and industry observers will be closely watching the company's ability to balance regulatory compliance with its growth initiatives.