Granules India

Granules India reported a Q1 FY26 revenue of ₹12,101 million, marking a 3% year-on-year growth and 1% quarter-on-quarter growth, which included ₹291 million from Senn Chemicals AG. The company achieved a strong gross margin of 64.9%, improving by 593 basis points YoY and 148 basis points QoQ. However, EBITDA declined by 4.85% YoY to ₹2,467 million, with the EBITDA margin at 20.4%, down 159 basis points YoY and 69 basis points QoQ, primarily due to increased professional expenses for remediation and higher manpower costs from the Senn Chemicals acquisition. R&D expenses were ₹678 million, representing 5.6% of sales, while ROCE stood at 16%, a slight dip from 16.6% in Q4 FY25.

The company is in the final stages of remediation at its Gagillapur facility following the August 24th US FDA warning letter, with a fourth status report submitted on July 31st. Management anticipates a re-audit and clearance by the end of December 2025. Meanwhile, the new Greenfield Formulations facility at Genome Valley successfully completed its first-ever FDA pre-approval inspection from July 28th to August 1st with a single procedural observation, unlocking an additional 10 billion doses of formulations capacity. The API Unit I facility at Bonthapally also completed an FDA inspection in June '25 with a single observation, and the site has cleared inspections by German and Danish authorities.

Granules India has made a significant strategic entry into the high-growth peptide therapeutics and CDMO space through the acquisition of Senn Chemicals and the creation of Ascelis Peptides. Senn Chemicals, a Swiss-based CDMO, brings over six decades of expertise in liquid and solid-phase peptide synthesis. The current annualized book of business for Senn Chemicals is in the range of CHF15 to CHF20 million. Granules plans additional investments of approximately ₹100 crores in Switzerland and ₹20-30 crores for an R&D lab in India for FY26, with a commercial scale peptide manufacturing facility in India targeted for completion by end of FY27. The goal is to position Ascelis as a credible, mid-size CDMO player within three to five years, with Senn Chemicals expected to match the parent company's return metric within 12 to 18 months.

The successful FDA inspection of the Genome Valley facility is expected to free Granules from delivery constraints, establishing a second source of supply for finished dosages and PFIs to the US. Supplies of monograph products to the US have commenced, with prescription product ramp-up following FDA approval. The new GLS facility is expected to be fully ramped up by Q1 FY27, with one large volume molecule alone capable of utilizing 35-40% of its capacity. Europe's revenue contribution is projected to reach 15-20% of total revenue going forward^⏳, supported by increased supply capabilities and new product launches, with 6 out of 10 pending approvals expected to launch soon.

Granules continues to invest significantly in R&D, with expenses at 5.6% of sales in Q1 FY26. The company's R&D efforts are primarily focused on high-value segments such as CNS ADHD (control substances) and oncology, in addition to large-volume integrated products. These areas involve higher spend due to global expansion and the pursuit of first-to-file products and 505(b)(2) opportunities. Oncology products are anticipated to launch in global markets within three to four years, aligning with their off-patent timelines. The Peptides R&D Facility and Center of Excellence at IIT Hyderabad is scheduled to become operational by October 2025.

On the sustainability front, Granules was recognized on the 2024 CDP Supplier Engagement A-List for leadership in supplier climate action and value chain emissions management. The company also joined the pharmaceutical supply chain initiative, reinforcing its commitment to transparency, sustainable operations, and global supply chain excellence. These initiatives build upon its SBTI-validated net-zero targets, EcoVadis Gold Medal, and CDP Climate Score of B, demonstrating a strong focus on environmental and governance practices.