Slide 1: Investor Presentation
Investor Presentation October 2024
Slide 2: Disclaimer
Disclaimer This presentation and the accompanying slides (the “Presentation") contain selected information about the activities of statements as a result of a number of risks, uncertainties and assumptions. Although the Group believes that such forward Wockhardt Limited ("Company") and its subsidiar
Slide 3: Global Research-Driven multinational
Global Research- 77% Driven Revenues from International Business1 multinational 18.5% Revenues from Biotechnology & Novel Antibiotics1 Novel Antibiotics Biotechnology Pharmaceuticals Vaccines 3 1. FY24
Slide 4: Stronger business performance
Stronger business performance 76% 0.13 Y-o-Y EBITDA growth1 Net Debt : Equity ratio2 30% growth INR 499 Cr. for biosimilars in emerging markets3 Reduction in debt4 1. Growth in FY24 over FY23 2. As on 31st March 2024, excluding promoter debt & net of cash & cash equivalents and other bank balances (
Slide 5: Portfolio of novel antibiotics to tackle global AMR threat
Wockhardt’s portfolio of 6 novel antibiotics is well placed to tackle global Antimicrobial Resistance threat that could potentially lead to 8 million deaths annually by 2050 ZAYNICH® MIQNAF® EMROK® / (WCK 5222) (Nafithromycin) EMROK O® Global Phase III >90% recruitment Filed for approval Commerciali
Slide 6: Wockhardt is well poised for growth
Wockhardt ZAYNICH + MIQNAF launches in India followed by global markets is well poised for Biosimilars growth Insulin Analogs in Global markets 6
Slide 7: Wockhardt Snapshot
Wockhardt Snapshot
Slide 8: Infrastructure
Snapshot of Wockhardt 12 manufacturing facilities across world Total Income1 (FY24) INR 2,879 Cr. 2 R&D centres one each in India, UK Infrastructure EBITDA1 > 350 scientists with 63 PhD’s; Drug INR 251 Cr. (FY24) Discovery team of 132 associates2 3,265 patents filed; 842 patents granted2 New Chemica
Slide 9: Global footprint
Global footprint Global operations Capability across different segments ► Branded ► Novel Antibiotics ► OTC ► Biotechnology ► Hospitals ► Pharma Generics 12 manufacturing facilities across the globe ► Solids ► Liquids ► Injectables ► Nasal sprays ► Biotechnology ► Complex technologies Direct operati
Slide 10: Financial Highlight: 14% income growth
Financial Highlight: 14% income growth1 Total Income2 in INR Cr. Total Income (Quarterly)1 in INR Cr. 7% growth2 14% growth1 2,879 747 2,693 658 FY23 FY24 Q1 FY24 Q1 FY25 1. Q1 FY25 vs Q1 FY24, excluding exchange rate fluctuations 10 2. FY24 vs FY23, excluding exchange rate fluctuations
Slide 11: Financial Highlight: Improvement in EBITDA margins
Financial Highlight: Improvement in EBITDA margins EBITDA2 in INR Cr. EBITDA (Quarterly)1 in INR Cr. 76% growth2 213% growth1 251 100 143 32 FY23 FY24 Q1 FY24 Q1 FY25 EBITDA Margin 5% 9% 5% 13% 1. Q1 FY25 vs Q1 FY24, excluding exchange rate fluctuations 11 2. FY24 vs FY23, excluding exchange rate fl
Slide 12: Reduction in External Long-term Loans
Reduction in External Long-term Loans Reduction in external long-term loan1 (INR Cr.) 828 557 391 355 As on 31st March 2022 31st March 2023 31st March 2024 30th June 2024 12 1. Excluding promoter debt & working capital loans
Slide 13: Net Debt : Equity @ 0.13
Net Debt : Equity @ 0.131 Debt Reduction by INR 499 Cr.2 Equity INR Cr. Debt3 INR Cr. 4,202 3,662 3,662 882 975 476 As at 31st March 2022 31st March 2023 31st March 2024 As at 31st March 2022 31st March 2023 31st March 2024 Cash & Cash Equivalents and other Bank Balances INR Cr. Net Debt-Equity Rati
Slide 14: Additional Short-term and Mid-term growth drivers
Additional Short-term and Mid-term growth drivers 3 years growth 5 years growth drivers drivers Diabetes Biosimilars for India + Novel drug discovery – Zaynich® (WCK 1 Emerging markets – Glargine, new 1 5222), Miqnaf ® (Nafithromycin), Insulin Analogs, Human Insulin Odrate® (WCK 6777) Novel drug dis
Slide 15: New Chemical Entity (Novel Antibiotics)
New Chemical Entity (Novel Antibiotics) 15
Slide 16: Annual deaths due to AMR estimated to be > 8 million
Annual deaths due to Anti Microbial Resistant (AMR) estimated to be > 8 million annually by 2050 Annual deaths associated with AMR in millions Cumulative deaths associated with AMR in millions ~2x 169 8.22 4.71 2021 2050 2025-2050 The global economy faces a potential $100 trillion economic catastrop
Slide 17: Wockhardt's Novel Antibiotics
Wockhardt’s Novel Antibiotics ~25 Focused commitment to Novel Antibiotics research leading to end-to- end Discovery & Development capabilities years Programs granted QIDP* status by US FDA denoting unmet needs; 6 abridged trials, faster review and approvals by US FDA * Qualified Infectious Disease P
Slide 18: Novel Antibiotics pipeline encompassing all the Resistant Organisms
Novel Antibiotics pipeline encompassing all the Resistant Organisms Gram Negative Portfolio Gram Positive Portfolio ZAYNICH® FOVISCU® ODRATE® EMROK® / MIQNAF® (WCK 5222) (WCK 4282) (WCK 6777) EMROK O® (Nafithromycin) Carbapenem resistant Phase I Launched in India; Global Phase III Phase III Phase II
Slide 19: Top 6 Super bugs inflicting global mortality
Top 6 Super bugs inflicting global mortality Number of deaths associated with Anti-Microbial Resistance 829,000 748,000 642,000 596,000 423,000 334,000 Acinetobacter Escherichia Coli Klebsiella Pseudomonas Staphylococcus Pneumococcus 19
Slide 20: ZAYNICH (WCK 5222)
® ZAYNICH (WCK 5222) Establishing ꞵ-lactam enhancer - a new class of antibiotic to treat MDR/ XDR Gram- negative infections
Slide 21: WCK 5222: Cefepime + Zidebactam [ZAYNICH]
WCK 5222 : Cefepime + Zidebactam [ZAYNICH®] Late-stage novel mechanism-based, first-in-class life-saving destination therapy for MDR/XDR Gram-negative infections in ICU setting Unmet Need Solution: WCK 5222 : Cefepime + Zidebactam High Carbapenem resistance globally Life Saving Safer therapy Acineto
Slide 22: WCK 5222: Cefepime + Zidebactam [ZAYNICH]
WCK 5222 : Cefepime + Zidebactam [ZAYNICH®] Late-stage novel mechanism-based, first in class life-saving destination therapy for MDR/XDR Gram-negative infections in ICU setting Indication potential WCK 5222 Complicated Urinary tract Infection Patents: Compound & Composition patent granted in key mar
Slide 23: WCK 5222 displays broadest coverage of MDR/XDR Gram negative pathogens
WCK 5222 displays broadest coverage of MDR/XDR Gram negative pathogens Differentiation endorsed by leading global KOL based on published literature Activity against resistant infection Best comparable Pipeline Drugs Best available Approved Drugs WCK Product Product Organism/ Resistance Mechanism Pro
Slide 24: WCK 5222 Development status
WCK 5222 Development status WCK 5222 (Cefepime + Zidebactam) – Destination therapy for XDR Gram Negative Acinetobacter & Pseudomonas Pre-clinical Phase 1 Phase II* Global Phase III Regulatory Global Completed (on-going) filings Launch • Phase I studies completed Unmet Need • Clinical Pulmonary PK, r
Slide 25: WCK 5222: Key updates
WCK 5222 : Key updates Continued success under compassionate use program 1 38 patients treated with WCK 5222 resulting in complete clinical as well as microbiological cure US FDA granted Expanded Access IND (compassionate use) for use of WCK 5222 in a young patient 2 Post treatment with WCK 5222, pa
Slide 26: ZAYNICH has treated 38 patients under compassionate use
ZAYNICH® (WCK 5222) has treated 38 patients under compassionate use 1 program so far in India Pathogens inflicting infections and associated indications of 38 patients Complete clinical as well as microbiological cure attained in all patients Indication wise split for patients treated 38 Patients Tr
Slide 27: US FDA Expanded Access IND granted for WCK 5222
2 US FDA under Expanded Access IND provision granted permission for use of WCK 5222 in a young patient Patient with multiple sites of infection in large wounds Patient was not responding to available antibiotic treatment WCK 5222 was initiated on patient post US FDA approval under Expanded Access IN
Slide 28: CLSI assignment of susceptibility breakpoint to WCK 5222
3 CLSI (USA) assignment of susceptibility breakpoint of 64 µg/mL to WCK 5222 for major group of Gram-negative pathogens even before US FDA approval MIC breakpoint has been granted for all three major Gram-negative pathogen CLSI (USA) recently granted a susceptibility breakpoint of 64 µg/mL 1 For all
Slide 29: Status of on-going clinical studies for WCK 5222
4 Status of on-going clinical studies for WCK 5222 Global India cUTI study status Carbapenem resistant organism (CRO) study status More than 90% patient recruitment completed India study status • Total Patients: 528 • Total Patients: 60 • Patients recruited: > 90% • Patients recruited: ~ 60% • Sites
Slide 30: MIQNAF (Nafithromycin)
MIQNAF® (Nafithromycin) Next generation respiratory tract infection antibiotic 30
Slide 31: Nafithromycin (Miqnaf): Broad spectrum novel lactone ketolide
Nafithromycin (Miqnaf®): Broad spectrum novel lactone ketolide for Community Acquired Bacterial Pneumonia (CABP) & Upper Respiratory tract infections(RTI) Increasing resistance and incomplete coverage for current treatment options: 1 • Macrolides (Azithromycin, Erythromycin) resistance in S. Pneumon
Slide 32: Biotechnology
Biotechnology
Slide 33: Well positioned to capture value in diabetes biosimilars market
Wockhardt - Well positioned to capture value in diabetes biosimilars market Focused on the antidiabetic biologics market characterized by high entry barriers and limited 1 competition 2 Wockhardt advantage of vertically integrated, competitive business model in Diabetes Biosimilars R&D infrastructur
Slide 34: Competitive advantage by providing integrated solutions in Diabetes Biosimilars
Competitive advantage by providing integrated solutions in Diabetes Biosimilars R&D Capabilities: Commercialization model 1 • Yeast, Bacterial & Mammalian expression • Focused only on Insulin, Insulin Analogs India • Through own field force for promotion to Product development: Diabetologists/ Endoc
Slide 35: In-house R&D and clinical capabilities for antidiabetic biosimilars
In-house R&D and clinical capabilities to develop antidiabetic biosimilars for global markets Integrated R&D centers In-house bioassay labs and clinical unit 46 product patents in biosimilar In-house bio-assay capability and… ~100 scientists including 14 PhDs1 incl. 23 patents for pen device1 ► In-h
Slide 36: Integrated manufacturing infrastructure
Integrated manufacturing infrastructure Drug substance facilities Drug product facilities Manufactures all recombinant biopharmaceutical drug 3 fully equipped drug product (DP) facilities substances (DS) at its own facilities Facilities handle various dosage forms: cartridges, vials, pre- filled syr
Slide 37: Diabetes Biosimilars for Emerging markets - Competitive scenario
Diabetes Biosimilars for Emerging markets - Competitive scenario Barriers to entry- 1 Limited competition 6-7 development time, players dedicated manufacturing 2 Registered in emerging markets >30 ~270 registrations across dosage forms markets Manufacturing infrastructure ready API + Low-cost manufa
Slide 38: Comprehensive antidiabetic biosimilars pipeline
Comprehensive antidiabetic biosimilars pipeline across Human Insulin & Insulin analogs Commercialized products Pipeline : Insulin and Insulins analogs Product Target Market Product Target Market Recombinant Human Insulin Glargine 100 IU Glargine 100 IU Aspart R Lispro R Aspart Mix WCK 9406 (Fast-act
Slide 39: Development status of Insulin analogues in Emerging Markets
Development status of Insulin analogues in Emerging Markets Aspart R Aspart 30/70 Lispro R WCK 9406 Process development ✓ ✓ ✓ ✓ Process Scale Up ✓ ✓ ✓* Planned Drug substance validation ✓ ✓ ✓* ✓ batches Drug product validation ✓ batches PK/PD study ✓ Planned Planned Planned Analytical similarity ✓ F
Slide 40: Status of Insulin analogues for Developed Markets
Status of Insulin analogues for Developed Markets Product Insulin type Development stage 1 Insulin Glargine Long-acting Analogue GMP batches for Clinical 2 Insulin Aspart Rapid-acting Analogue Product developed / Under optimization 3 Insulin Lispro Rapid-acting Analogue Product developed / Under opt
Slide 41: Differentiated business model: range, cost competitiveness & market access
Wockhardt differentiated business model: comprehensive range, cost competitiveness & market access Wockhardt Cost advantages A Product development stage B Product manufacturing stage Advanced clinical Indigenously designed and Vertically integrated In-house Bio-assay labs pharmacokinetic unit patent
Slide 42: Abbreviations
Abbreviations ®: Registered Gram –ve: Gram negative NPRA – National Pharmaceutical Regulatory Agency ~: Approximate Gram +ve: Gram positive OPD: Outpatient Department A.baumannii: Acinetobacter baumannii HABP: Hospital Acquired Bacterial Pneumonia oprD: Outer membrane porin ABSSSI: Acute bacterial s
Slide 43: Thank You
Thank You