Zydus Lifesciences Limited has announced the launch of PEPAIR™, marking a significant milestone as India's first affordable Oscillating Positive Expiratory Pressure (OPEP) device. The innovative, drug-free handheld device is designed to support better respiratory health for patients suffering from chronic respiratory conditions, addressing a critical healthcare gap in the Indian market.

Product Features and Pricing

PEPAIR™ incorporates a patented design with a 3-resistance system specifically engineered to help clear congestion and support effective mucous clearance. The device aims to improve breathing in patients diagnosed with COPD, asthma, and bronchiectasis. In a patient-centric approach, the company has positioned the device at an affordable price point to ensure broader accessibility.

Market Need and Patient Impact

The launch addresses a substantial healthcare challenge, with more than 90 lakh patients suffering from chronic respiratory conditions in India. Chronic mucous hypersecretion represents a common problem among these patients, requiring effective airway clearance solutions for everyday care. OPEP-based airway clearance is recommended in established clinical guidance, but limited affordability has historically restricted access for a large proportion of patients.

Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, emphasized the company's commitment to patient-centric innovation: "At Zydus, patient-centric innovation is about advancing healthcare in ways that make everyday care more accessible for patients. With PEPAIR™, India's first affordable OPEP device, we are introducing a drug-free, handheld solution designed to support better breathing for patients with COPD, asthma and bronchiectasis."

Technology and Therapeutic Benefits

OPEP therapy utilizes a handheld, translucent device that creates pressure and vibrations during exhalation to loosen mucous, open airways, and promote clearance. PEPAIR™ contributes to clearing impaired mucociliary pathways, removing airway obstruction, reducing cough, and delivering optimal therapeutic response. The device operates without requiring any pharmaceutical intervention, making it a valuable addition to respiratory care management.

Strategic Partnership

The launch represents a collaboration between Zydus Lifesciences and AeroDel Technology Innovations Pvt. Ltd, an Indian medical device company focused on simplifying inhalation through drug-delivery and pulmonary rehabilitation. AeroDel serves as both the innovator and developer of the underlying OPEP device platform for PEPAIR™ and the manufacturing partner for the project.

Company's Respiratory Portfolio

Zydus maintains its position as one of India's largest respiratory players, supported by a comprehensive legacy in oral and inhalation therapies. The company leads the oral bronchodilator segment with Deriphyllin®, recognized among India's most prescribed methylxanthines. The respiratory portfolio spans multiple therapeutic categories:

• Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA) combinations
• LABA + Long-Acting Muscarinic Antagonist (LAMA) formulations
• Single Inhaler Triple Therapy (SITT) solutions
• Once-daily triple therapies including Odihale®G and Umiflo® Plus

The company pioneered several innovations in the respiratory space, including being first to introduce LABA+LAMA with Forglyn® and pioneering SITT with Forglyn® Plus.

The Board of Directors of Zydus Lifesciences Limited approved the unaudited financial results for the quarter and nine months ended December 31, 2025, at their meeting held on February 9, 2026. The company subsequently held its Q3FY26 post-results earnings call on February 10, 2026, pursuant to regulations 30 and 46(2)(oa) of the SEBI Listing Regulations.

Board Meeting and Regulatory Compliance

The meeting commenced at 11:10 a.m. and concluded at 1:15 p.m., with results reviewed by the Audit Committee and taken on record by the Board pursuant to Regulation 33 of SEBI Listing Regulations. The financial results were prepared in accordance with Indian Accounting Standards (Ind AS) and underwent limited review by statutory auditors Deloitte Haskins & Sells LLP.

Consolidated Financial Performance Q3FY26

The company demonstrated robust consolidated performance during Q3FY26. Total revenue from operations reached ₹68,645 million, representing significant 30.30% year-over-year growth from ₹52,691 million in Q3FY25. Net profit for the quarter stood at ₹10,421 million compared to ₹10,235 million in the corresponding quarter of the previous year, marking a 1.82% increase. EBITDA for the quarter stood at ₹18.20 billion, up 31% year-on-year with an EBITDA margin of 26.50%.

Business Segment Performance

North America Operations

The North America business, comprising the United States and Canada, registered revenues of ₹28,000 million during the quarter, up 16% year-on-year. The base US business continued to grow driven by sustained volume expansion and new products launched over the last 12 months. The company filed 18 ANDAs, received 8 approvals and launched 4 new products during the quarter. On the US specialty front, the company launched BEIZRAY (albumin-solubilized docetaxel injection), its first oncology 505(b)(2) product.

India Branded Formulations

The India branded formulation business sustained its growth trajectory with a robust 14% year-on-year growth, outperforming the market growth. The growth was driven by persistent traction in innovation products and pillar brands, with the chronic segment continuing to grow at a faster pace. Contribution of chronic portfolio increased to 45.30% as per IQVIA MAT December 2025.

International Markets and Consumer Wellness

International markets formulation business posted revenues of ₹7.90 billion with strong year-on-year growth of 38%. The Consumer Wellness business recorded revenues of ₹9.60 billion, up 113% year-on-year with full quarter consolidation of Comfort Click business.

Strategic Developments and Innovation Pipeline

During the earnings call, Managing Director Dr. Sharvil Patel highlighted key strategic developments. The company plans to file Saroglitazar Magnesium with the USFDA for PBC indication, marking a pivotal milestone for growth in the specialty pharmaceutical space. In January 2026, the company received final approval from the USFDA for Zycubo (copper histidinate), becoming the first and only therapy approved for the treatment of Menkes disease.

The company has licensed two large molecules, Pembrolizumab and Ranibizumab biosimilars, leveraging the recently acquired biologics manufacturing facility in the US. The company expects to launch Ranibizumab in the second half of the year and aims for meaningful Bio CDMO business development over the next 2-3 years.

Exceptional Items and Future Outlook

The quarter's results were affected by exceptional items totaling ₹849 million, primarily attributed to the one-time impact of New Labour Codes implementation. The company expects R&D expenses to remain at 7.50%-8.00% of revenue for FY26, with Q4 EBITDA margins expected to be 23% plus despite minimal Lenalidomide revenue.

Management expressed confidence in continued double-digit growth across key business segments, with the US generics business showing 11% volume growth and international markets expected to maintain 20% plus growth trajectory.

Source: Earnings Call Transcript