### **Overview** Glenmark Pharmaceuticals Ltd. is a global, research-driven, integrated pharmaceutical company advancing up the value chain by transforming from a generics manufacturer into an innovation-led, specialty-focused enterprise under its strategic vision *Glenmark 3.0*. With operations in over 80 countries and a balanced presence across branded generics, specialty medicines, and over-the-counter (OTC) products, the company generates approximately **$1.6 billion** in consolidated revenue (FY2025). Over **60% of revenue** comes from branded markets, reflecting its successful pivot toward high-value therapeutic areas. The company operates **11 manufacturing facilities** and **4 advanced R&D centers** globally, supporting end-to-end capabilities from discovery to commercialization. It employs more than **15,000 people** worldwide and maintains a diverse product portfolio across **Dermatology, Respiratory, Oncology, Cardiology, Diabetes, and Women’s Health**. --- ### **Strategic Pillars** Glenmark has restructured its business around **three core therapeutic areas**: 1. **Dermatology** – Global leadership with science-backed brand building. 2. **Respiratory** – Innovation in chronic conditions, allergy, and COPD. 3. **Oncology** – Expansion into specialty immunooncology and targeted therapies. The company is targeting to increase the share of branded revenues to **~70% by FY2029**, backed by strategic in-licensing, internal innovation, and global commercial partnerships. --- ### **Therapeutic Focus & Key Developments** #### **1. Dermatology: A Global Leader with Scientific Foundation** - **Core Franchise**: With over **120 brands** addressing more than 15 skin conditions (acne, psoriasis, fungal infections, atopic dermatitis, vitiligo), Glenmark is the **#1 dermatology player in Malaysia, Philippines, and Sri Lanka**, and maintains **India’s #2 position**. - **Branded Portfolio Expansion**: - Launched **Jabryus® (abrocitinib)**, an oral JAK1 inhibitor, in India for moderate-to-severe atopic dermatitis — a first-in-50-years systemic therapy for this indication. - Secured **MHRA approval** and launched **Winlevi® (clascoterone 1%)**, a novel androgen receptor inhibitor, in the **UK**, with planned rollout across **15 EU markets and South Africa** in FY2026 via Cosmo Pharmaceuticals. - Introduced **Supirocin™ (mupirocin)** in Australia, marking entry into the branded dermatology market. - Expanded in APAC with launches of **Aprezo©, Dispotrex B, Oflomil®, and Bontress®**, a cosmetic OTC brand. - **Consumer Care & OTC**: - Flagship brands: **Candid®, La Shield®, Scalpe®, Episoft®**. - Launched **La Shield Kids** (100% mineral sunscreen for children) and **Episoft AC 50+** (hydrating sunscreen for Indian climate). - **Scalpe Pro** became the #1 bestseller on Amazon India in its category. --- #### **2. Respiratory: Innovation in Allergy and Chronic Diseases** - **Ryaltris® (Mometasone + Olopatadine Nasal Spray)**: - Flagship **first global branded specialty product** approved in **44+ countries** (including U.S., Canada, EU, Australia, South Korea, Russia, and Saudi Arabia). - Achieved **#3 in Mexico’s nasal spray market** and **>10% share in Canada within one year** of launch. - Partnered with **Hikma (U.S.), Menarini (Europe), Bausch Health (Canada), and Grand Pharmaceutical (China)**. - Plans to launch in **15 new markets globally**, especially in **Latin America**, over the next 12 months. - Holds **53% growth in APAC** (FY2024), with strong uptake in Australia and Korea. - **Portfolio Expansion**: - Launching **complex MDIs and nasal sprays** in the U.S. and Europe. - **VILOR® FG DPI/pMDIs** (triple-therapy: Vilanterol, Glycopyrronium, Fluticasone) launched for **COPD** with improved cardiac safety. - **Nindanib™** leads the Nintedanib segment in IPF; **Ascoril® LS** is India’s largest cough brand. - Launched **Marimer®** (isotonic nasal spray) in Germany for respiratory hygiene. - In India, holds the **#3 position in respiratory IPM segment**, with **Vilor-F™ and Alex® brands** among the Top 300 pharma brands. --- #### **3. Oncology: Building a Global Specialty Portfolio** - **Commercial Portfolio**: - Launching and commercializing **global standard therapies** in India: - **TEVIMBRA® (tislelizumab)** – PD-1 inhibitor. - **Brukinsa® (zanubrutinib)** – BTK inhibitor. - **Glenza® (enzalutamide)**, **Abirapro™ (abiraterone)**, **Aprecap® (aprepitant)**. - In **Europe**, markets **Abiraterone**, **Atanto® (aprepitant)**, **Azacitidine™**, and **Eribulin**. - In **Latin America**, launched **Gemcitabine and Abiraterone** for breast, prostate, and lung cancers. - **Pipeline & Launch Pipeline**: - **QiNHAYO™ (envafolimab)**, a **first-in-class subcutaneous PD-L1 inhibitor**, to launch in **FY2026** in select markets. Licensed from Alphamab, approved in China for MSI-H/dMMR tumors. - Regulatory submissions completed in **13 markets**, with **Saudi Arabia granting priority review**. - Early access programs launched in **Kenya and Mauritius**. - **Regional Expansion**: - Out-licensed **Abiraterone** to **Viatris in Australia**. - Entered COPD oncology with **Duaklir® and Eklira®** (licensed from AstraZeneca) in Brazil. - Ranked **17th overall and 9th among Indian companies in oncology**, with **22.4% YoY revenue growth**. #### **Innovation Engine: Ichnos Glenmark Innovation (IGI)** - **IGI** is Glenmark’s **clinical-stage biotech subsidiary** focused on multispecific antibodies and small molecules for **hematological malignancies and solid tumors**. - **Headquarters**: New York; Innovation Hubs: **Lausanne (Switzerland), Mahape (India)**. - **Led by Dr. Cyril Konto**, CEO, IGI operates with 100+ scientists and end-to-end capabilities in discovery, CMC, and clinical development. - **Revenue Model**: Earns from **out-licensing** and **tiered royalties**, with $700M upfront from AbbVie on ISB 2001, and up to $1.225B in milestones. ##### **IGI’s Proprietary BEAT® Platform** - Enables development of **multispecific immune cell engagers** with natural antibody-like stability. - Overcomes traditional bispecific challenges using **common light chain (CLC) libraries** and **TCR-inspired interface**. - Engages **T cells, NK cells, and myeloid cells** via multiple antigen targeting. ##### **Pipeline Highlights (Oncology Focus)**: - **ISB 2001 (CD38 x BCMA x CD3 trispecific T-cell engager)**: - In **Phase 1 global trial (TRIgnite-1)** for relapsed/refractory multiple myeloma. - Received **Orphan Drug + Fast Track Designation (U.S. FDA)**. - **AbbVie partnership**: Holds rights for North America, Europe, Japan, and Greater China; **Glenmark retains Emerging Markets**. - **ISB 2301**: NK-cell engager for solid tumors — **preclinical stage**. - **GRC 65327**: Cbl-b inhibitor (oral small molecule) for solid tumors — **IND submitted to DCGI**, FIH trials expected in **2026**. - Additional candidates: **ISB 1442 (CD38 x CD47)** in Phase 1 for myeloid cancers. ##### **Strategic Out-Licensing (Oncology Focus)** - Shifted from autoimmune to **oncology-only R&D focus**. - Out-licensed: - **ISB 880 (anti-IL-1RAP)** to **Almirall S.A.** (Phase 1 ongoing). - **ISB 830 & ISB 830-X8 (OX40 antagonists)** to **Astria Therapeutics** (after successful Phase 2b in atopic dermatitis). --- #### **4. Diabetes & Cardiometabolic** - **Cardiology**: - **5th largest in India**; **#1 brand franchise**: **Telma™** (Telmisartan-based ARB). - Launched **Telma™ BS** (Beta-blocker + ARB) for young hypertensive patients. - Scaling **SACU-V® (ARNI)** and **EPTUS® (Eplerenone)** in **Tier 2–3 cities**. - **Diabetes**: - Launched **Lirafit™ (Liraglutide biosimilar)** — top 10 product in FY2025 with 10% patient share. - **Zita® DM** — India’s **first triple FDC** (Teneligliptin + Dapagliflozin + Metformin), priced 30% below market, reducing daily burden. - Marketed **Sitazit-Trio™ (Sitagliptin + Metformin + Pioglitazone)**. - Acquired first-to-file **generic SGLT2 inhibitors** post-loss-of-exclusivity. --- ### **Global Manufacturing & R&D** - **11 Manufacturing Sites**: Covering oral solids, semi-solids, injectables, inhalers, APIs, and biologics. - **4 R&D Centers**: Navi Mumbai (Taloja), Goa, Maharashtra; Switzerland (Lausanne); U.S. (New York). Focus on: - **Aerosol & drug-device combos** (MDIs, DPIs, nebulizers). - **Complex generics** (injectables, nasal sprays). - **Nitrosamine detection labs** and hormone facility upgrades. - **API Division**: **Glenmark Life Sciences (GLS)** supplies 139 APIs, serves 700+ clients, and has a CDMO business with 3 active projects. - **Low GWP Propellants**: Developing **HFA 152a**-based pMDIs to reduce carbon footprint by >90%. --- ### **Financials & Operations (FY2025)** - **Consolidated Revenue**: **INR 133 billion (~$1.6B)**. - **EBITDA Margin**: Improved to **17.7%**, driven by operational excellence. - **Export Revenue**: **51.39% of standalone revenue (INR 47,416.62M)**. - **Product Launches**: 75+ globally; **13 new products in U.S.** (FY2025). - **ANDA Pipeline**: **52 pending** in U.S. FDA, including **24 Paragraph IV filings**. --- ### **Strategic Partnerships & Commercial Strategy** - **Oncology**: - **BeiGene**: In-licensed **Tislelizumab** and **Zanubrutinib** for India. - **Alphamab**: Licensed **Envafolimab (QiNHAYO™)** for emerging markets. - **AbbVie**: Strategic co-development of **ISB 2001**; global access model. - **Dermatology**: - **Cosmo Pharmaceuticals**: Winlevi® distribution in Europe and South Africa. - **Pfizer**: Co-commercialized **Jabryus®** in India. - **Respiratory Partners**: Hikma (U.S.), Menarini (Europe), Bausch (Canada), Grand Pharma (China). - **CDMO & Alliance Model**: Operates long-term R&D and commercial alliances, including with Helsinn (Akynzeo®), AstraZeneca (Pulmicort Respules®), and Almirall (ISB 880).