Alembic Pharmaceuticals Limited (ISIN: INE901L01018) has reported a strong performance for the second quarter of fiscal year 2026, with significant revenue growth and strategic expansion into the US branded drug market.

Financial Highlights

Alembic Pharmaceuticals delivered impressive financial results for Q2 FY26:

The company's revenue growth was driven by higher volumes and new product launches across various business segments.

Business Segment Performance

• India Branded Business: Grew by 5% to ₹639.00 crores, with strong performance in Gynecology, Ophthalmology, and Animal Health segments.
• US Business: Expanded by 21%, supported by higher volumes despite pricing challenges.
• Rest of World Markets: Recorded a 31% growth, reflecting successful geographic expansion.
• API Business: Grew by 15%, contributing to the overall positive performance.

Strategic Developments

Alembic Pharmaceuticals has made a significant move into the US branded drug market:

• Acquired Utility Therapeutics for $4.00 million upfront, with additional milestone payments.
• Gained access to Pivya, a product for urinary tract infections, marking entry into the US branded segment.
• Plans to launch Pivya in late Q4 FY26, targeting a market with 30 million prescriptions annually.

R&D and Product Pipeline

The company continues to invest in research and development:

• Filed 2 ANDAs and received 6 approvals during the quarter.
• Launched 3 products in the US market.
• Cumulative ANDA filings stand at 269, with 226 approvals including 21 tentative approvals.
• Focused on complex areas such as injectables, peptides, and oral solids.

Management Commentary

Pranav Amin, Managing Director, stated, "Our Q2 performance reflects continued momentum as we strengthen our presence across key markets. We're particularly excited about our entry into the US branded drug market with Pivya, which we believe will be a significant growth driver in the coming years."

Outlook

Alembic Pharmaceuticals aims to improve EBITDA margins to 18-19% levels in the near term, with a goal of reaching 20% in the next couple of years. The company expects to launch 8-10 new products in the US market in the second half of FY26.

While the entry into the US branded drug market may impact near-term profitability, management is confident about the medium to long-term market opportunity.

Investors should note that the company's performance in the rest of world markets may normalize in the second half, given the lower base effect in the previous year's first half.

As Alembic Pharmaceuticals continues to execute its growth strategy and expand its product portfolio, it remains well-positioned to capitalize on opportunities in both domestic and international markets.

Alembic Pharmaceuticals Limited has achieved significant milestones in its pharmaceutical journey by receiving final approvals from the U.S. Food and Drug Administration (USFDA) for its Dasatinib tablets and Sumatriptan Injection USP. These developments mark crucial steps forward for the company in expanding its presence in the U.S. market.

Key Highlights

Dasatinib Tablets

• Approval Details: Alembic Pharmaceuticals has received USFDA final approval for Dasatinib tablets in six different dosages: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
• Market Potential: The estimated market size for Dasatinib tablets stands at $1,017.00 million, based on IQVIA data for the twelve months ending September 2023.
• Therapeutic Equivalence: The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Bristol-Myers Squibb Company's Sprycel Tablets, the reference listed drug (RLD).

Sumatriptan Injection USP

• Approval Details: Alembic Pharmaceuticals received USFDA final approval for Sumatriptan Injection USP in 4 MG/0.5 ML and 6 MG/0.5 ML dosages delivered through a single-dose autoinjector.
• Significance: This represents the company's first drug-device combination product.
• Market Potential: The market size for this product is $73.00 million.

Medical Applications

Dasatinib Tablets

Dasatinib tablets are indicated for the treatment of:

1. Adult patients with:
   • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
   • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
   • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
2. Pediatric patients 1 year of age and older with Ph+ CML in chronic phase

Alembic's ANDA Portfolio

These approvals further strengthen Alembic Pharmaceuticals' position in the generic pharmaceutical market. The company now boasts a cumulative total of 227 ANDA approvals from the USFDA, comprising 207 final approvals and 20 tentative approvals.

Company Background

Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development pharmaceutical company. With its headquarters in India, Alembic Pharmaceuticals is a publicly listed company that manufactures and markets generic pharmaceutical products globally. The company's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities of many developed countries, including the USFDA.

Market Impact

The approvals of Dasatinib tablets and Sumatriptan Injection USP are expected to bolster Alembic Pharmaceuticals' position in the U.S. pharmaceutical market. With an estimated market size of over $1 billion for Dasatinib tablets and $73 million for Sumatriptan Injection, these approvals open up significant revenue potential for the company.

As Alembic Pharmaceuticals continues to expand its product portfolio and secure regulatory approvals, it reinforces its commitment to providing high-quality, affordable generic medications to patients worldwide.