### **Overview** Zydus Lifesciences Limited is a globally integrated life sciences company engaged in the discovery, development, manufacturing, and marketing of a broad portfolio of healthcare therapies. Operating across pharmaceuticals, biologics, medical technology (MedTech), vaccines, consumer wellness, and animal health, the company serves over **75 countries** with a diversified product mix and a strong innovation-driven strategy. With over **28,000 employees worldwide**, including 1,500 R&D scientists, Zydus is positioned as a leading player in multiple therapeutic areas and markets. --- ### **Core Business Segments** #### **1. US Generics & Specialty Business** - Zydus is a **top-five generic drug player in the US by prescription volume** (IQVIA, MAT March 2025). - The US market is its **largest revenue contributor**, accounting for **49% of consolidated revenue** in FY2024, with the business exceeding **$1 billion in annual revenue**. - The company is strategically **shifting from volume-centric to a value-centric model**, focusing on **complex generics**, **505(b)(2) products**, **drug-device combinations**, **long-acting injectables**, and **orphan/rare diseases**. - Over the next five years, Zydus plans to **file 207 new products** targeting a $170 billion addressable market, with approximately **91 NCE-1/First-to-File (FTF) opportunities** and **11 long-acting injectables** in the pipeline. - As of FY2025, cumulative **FDA approvals stand at 421** with **486 total ANDA filings**, reinforcing execution excellence. #### **2. Specialty & Rare Diseases (Via Sentynl Therapeutics)** - Zydus acquired **Sentynl Therapeutics Inc.**, a US-based specialty pharma subsidiary focused on **ultra-rare and orphan diseases**, to establish a commercial-ready platform. - The company has acquired **three globally impactful rare disease assets**: - **Nulibry® (Fosdenopterin)**: First & only FDA-approved treatment for **Molybdenum Cofactor Deficiency Type A (MoCD-A)**. - **Zokinvy® (Lonafarnib)**: First FDA-approved therapy for **Hutchinson-Gilford Progeria Syndrome (HGPS)**, a rare aging disorder. - **CUTX-101 (Copper Histidinate)**: Potential first-in-class therapy for **Menkes disease**, with **Orphan Drug, Fast Track, and Priority Review** designations from the US FDA. The NDA was accepted for filing in Q2 2025. - These brands are commercialized in the US, EU, UK, and other key markets, with exclusive licensing agreements enhancing global access. - The company is advancing **Usnoflast** (formerly ZYIL1), a **novel oral NLRP3 inflammasome inhibitor**, in **Phase II(b) trials for ALS**, with additional potential in **ulcerative colitis, Parkinson’s, and CAPS**. #### **3. Biologics & Biosimilars Leadership** - Zydus is a **leading biosimilars player in India** and among the top globally in complex biologics. - It launched **Ujvira™**, the **world’s first biosimilar of the antibody-drug conjugate (ADC) Trastuzumab Emtansine (Kadcyla®)**, revolutionizing affordability in HER2+ breast cancer therapy in emerging markets. - The company has **14+ commercialized biologics** in India, including novel biologics and biosimilars across **oncology, autoimmune, nephrology, and inflammation**. - In 2025, Zydus received approvals for **rituximab and aflibercept biosimilars** and initiated **Phase III trials for its second ADC**. - It aims to build a **$100 billion global biosimilars portfolio by 2028**, with a pipeline of **32 molecules** (14 commercialized) and **17 in development**. #### **4. Novel Drug Discovery (NCE/NBE Pipeline)** - Zydus is the **only Indian company to launch its own patented New Chemical Entity (NCE), Saroglitazar (Lipaglyn®)**, for diabetic dyslipidemia and **Non-Alcoholic Steatohepatitis (NASH)**. - Saroglitazar is undergoing **Phase II/III trials in the US for Primary Biliary Cholangitis (PBC)** and has received **Orphan Drug and Fast Track designation**. It is also being studied for **PCOS and NAFLD**. - The company has **multiple NCEs in development** via the **Zydus Research Centre (ZRC)** in Ahmedabad, which houses **over 500 scientists**, including 150 in biotech research. - Pipeline includes **ZyBK2 (rheumatoid arthritis), anti-malarial ZY19489**, and **Twinrab (anti-rabies monoclonal antibody)**. #### **5. Medical Technology (MedTech) Expansion** - In a major strategic pivot, Zydus entered the **global MedTech space** through the **acquisition of Amplitude Surgical SA**, a European leader in **lower-limb orthopedic technologies**, including hip and knee prostheses and a **surgical robot (Andy)**. - Amplitude Surgical holds **#2 rank in France, #6 in Europe, and #6 in Brazil**, with **€100+ million in annual revenue**. - Zydus also partnered with **Braile Biomedica** to commercialize an advanced **balloon-expandable TAVI (transcatheter aortic valve implantation) system** for high-risk cardiac patients. - A dedicated **Zydus MedTech** entity with **150+ professionals** was established, with focus areas in **interventional cardiology, orthopedics, and nephrology**. #### **6. Biologics CDMO & US Manufacturing Expansion** - Zydus is establishing a strategic **US-based biologics Contract Development and Manufacturing (CDMO) business** by acquiring **two state-of-the-art facilities from Agenus Inc. in Emeryville and Berkeley, California**. - Deal value: **$75 million upfront**, with **up to $50 million in contingent milestones** based on revenue. - As part of the agreement, Zydus secures **exclusive rights** to manufacture **Botensilimab (BOT)** and **Balstilimab (BAL)**, next-gen immuno-oncology checkpoint inhibitors in advanced development. - It also获得了 an **exclusive license for BOT/BAL in India and Sri Lanka**, supported by a **$16 million equity investment** in Agenus. #### **7. International Formulations Growth** - The **international formulations business** is a key growth pillar, delivering **strong double-digit growth** in emerging markets (Asia, Africa, MEA, LATAM) and Europe. - Zydus has **direct operations in France, Spain, and the UK**, and maintains **B2B partnerships across Europe**. - The company leverages **harmonized regulatory filings and shared pipelines** to accelerate global product rollouts. - Flagship brands include **Complan® and SugarFree™**, with international presence expanding in **SAARC, MEA, SEA, and ISC regions**. #### **8. India Business & Branded Portfolio Leadership** - Zydus is a **top-five player in India’s domestic pharma market** and **market leader in biosimilars and oncology**. - The **India formulations business** grows **faster than the overall market**, driven by innovative launches and expansion in key therapies like **oncology, nephrology, and cardiology**. - Key brands: - **Oxemia™ (Desidustat)**: India’s first **oral alternative to injectable ESA** for CKD anemia; has treated **65,000+ patients**. - **Ujvira™**: Treats >10,000 breast cancer patients. - **Lipaglyn®**: >3.8 million patients treated; **grew 38% in FY2024 patient base**. - The company is expanding in **modern trade and e-commerce channels**, leveraging **scientific innovation and patient-centric programs**. #### **9. Consumer Wellness (Zydus Wellness)** - Owns **iconic consumer brands**: **SugarFree, Complan, Nutralite, Glucon-D, Nycil, Everyuth, and ProV**. - Acquired **Naturell India Pvt. Ltd.**, a leader in **healthy snacking**, to expand into the **high-growth functional food segment**. - Key brands: **RiteBite Max Protein® and RiteBite®** (protein and fiber-focused snacks). - Growing across **e-commerce (10%) and modern trade (13% of FY25 revenues)**. #### **10. Strategic Joint Ventures & Alliances** - **Zydus – Perfect Day JV**: 50:50 joint venture to produce **animal-free, fermentation-based proteins** for health/nutrition. Will build a **1,600-kiloliter manufacturing facility** for global markets. - **Sterling Biotech JV**: Acquired 50% to enter **specialty biotech products** and animal-free protein ecosystem. - **Takeda JV**: Manufactures APIs/intermediates for export to Europe and Japan. - **Hospira-Pfizer JV**: Manufactures **oncology injectables**, with **7 million vials/year capacity** and **USFDA/EMA/PMDA/WHO compliance**. --- ### **Innovation & R&D Capability** - **R&D Expenditure**: 7–8% of revenue, consistently invested in innovation. - **Zydus Research Centre (ZRC)**: Central hub for NCE discovery with capabilities from **target identification to IND filing**. - **3 Pharmaceutical Technology Centres (PTCs)**: Focus on **market-specific generics development** for US, India, and emerging markets. - **Digital Innovation**: AI platforms like **FormDEM** (formulation stability prediction) and **Entvin** (reference product data repository), and **IRIS** (end-to-end launch tracking platform). - **Manufacturing Technology**: Advanced automation, **dark factory** concepts (SEZ Unit III), **continuous coating (850% improvement)**, and **NIR-based real-time monitoring**. --- ### **Manufacturing Footprint & Supply Chain** - Operates **39 global manufacturing facilities**, including **16 USFDA-approved** sites. - **Capacity diversification**: - 19 small molecule, 6 API, 3 biological, 5 vaccine, 4 consumer wellness, 1 animal health, 1 MedTech facility. - Vertically integrated supply chain ensures **minimal failure-to-supply penalties**, **launches 150+ products annually**, and supplies **4,850+ SKUs**. - Recent investments include: - **New oral solid dosage plant in Ahmedabad SEZ** (dark factory, zero-touch automation). - **Expansion of dialyser membrane manufacturing** to serve global CKD needs.