Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Corporate Update (December 2024)
24 slides from Teva Pharmaceutical Industries's corporate update, Dec 17, 2024
Slide 1: Duvakitug (Anti-TL1A) Phase 2 Top Line Results Investors Call
Teva Pharmaceutical Industries Ltd. Duvakitug (Anti-TL1A) Phase 2 Top Line Results Investors Call December 17, 2024
Slide 2: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our futu
Slide 3: President and Chief Executive Officer
President and Chief Executive Officer
Slide 4: Deliver on growth engines, step up innovation, sustain generics, focus our business
Deliver on Step up Sustain generics Focus our growth engines innovation powerhouse business 4|
Slide 5: Data show best-in-class efficacy and safety
Data show best-in-class efficacy and safety Teva and Sanofi committed to initiating phase 3 in IBD Approval in UC and CD will open up Duvakitug to the IBD market opportunity Positive results underscore Teva's ability to discover, develop and accelerate access to innovative medicines 5| Source: Evalu
Slide 6: Executive Vice President, Global R&D & Chief Medical Officer
Executive Vice President, Global R&D & Chief Medical Officer
Slide 7: Large Unmet Need for Patients in Inflammatory Bowel Disease (IBD)
Large Unmet Need Chronic inflammation of the gastrointestinal tract caused by an abnormal immune response for Patients in to gut microflora Inflammatory Bowel Disease (IBD) • 2.3M Ulcerative Colitis and 1.8M Crohn’s Disease patients diagnosed • <50% patients achieve clinical remission, and responsiv
Slide 8: TL1A drives multiple different pathways
• TL1A drives multiple different pathways • Potential direct effect on fibrosis • Implicated in a wide range of immune mediated and fibrotic diseases Jacob N, et al. Sci Rep. 2020;10:18189. Meylan F, et al. Mucosal Immunol. 2011;4(2):172-85.Valatas V, et al. Front Immunol. 2019;10:583. 8| Natural Ki
Slide 9: Duvakitug therapeutic concept and antibody generation
Duvakitug Therapeutic Concept: Human phage TL1A-DR3 Significant TL1A blockade → display library -selective Optimization: Improved: • anti-inflammatory inhibitors Ribosome display • affinity • anti-fibrotic • potency • developability Antibody Generation 9|
Slide 10: Antibody designed to block DR3 and not DcR3
TL1A binds to two receptors and Teva antibody strategically designed to block DR3 and not DcR3 DR3 receptor Desirable to block DcR3 decoy receptor Desirable to retain Involved in pro- Regulates excess inflammatory TL1A, maintaining signaling natural homeostasis 10 |
Slide 11: TEV-48574 potency and selectivity versus competitor antibodies
TEV-48574 84x more potent than anti-TL1A#2(1) and 117x more selective to DR3(2) receptor than DcR3(3) Inhibition of TL1A-induced apoptosis DR3:DcR3 selectivity (functional inhibition) in vitro 100 DR3 TEV 48574 150 DcR3 Anti-TL1A #2 % competition for TL1a (TL1A-induced response) 100 % Inhibition 50
Slide 12: Rapid & Sustained Reduction in Free TL1A in a Prior Study
Rapid & Sustained Reduction in Free TL1A in a Prior Study1 • Showed rapid and sustained reduction in free TL1A • Demonstrated favorable safety and tolerability profile • Showed less than 10% anti-drug antibodies 1. Phase 2a, Proof of concept, 16-week, randomized, double-blind, parallel-group POC stu
Slide 13: Phase 2b trial design
High-Dose Duvakitug Q2W SC Primary Endpoints: N = ~240 (~120 each) Loading Dose (SC) Primary Endpoint N=~40 (each in UC & CD) Extension Trial Randomization • UC: Clinical remission per Long-Term UC & CD Low-Dose Duvakitug Q2W SC Modified Mayo Score N=~40 (each in UC & CD) (mMS) Placebo • CD: Endosco
Slide 14: Met primary endpoints in UC and CD
UC: Met Primary Endpoint of Clinical Remission CD: Met Primary Endpoint Endoscopic Response (Modified Mayo Score; mMS) (Simple Endoscopic Score for Crohn’s Disease; SES-CD) 27.4%a 34.8%a 60% 60% p=0.003 p<0.001 Participants Achieving Endpoint (%) 47.8% 47.8% Participants Achieving Endpoint (%) 50% 1
Slide 15: Statistically significant and clinically meaningful responses
Statistically Significant and High Potency Clinically High Selectivity Meaningful Responses Low Anti-Drug Antibodies1 observed in Both Ulcerative Colitis Rapid, Profound, and Prolonged Suppression of Free TL1A1 and Crohn's Disease Consistent Favorable Safety and Tolerability To Date 15 | 1. In prior
Slide 16: Executive Vice President, Chief Financial Officer
Executive Vice President, Chief Financial Officer 16 |
Slide 17: Duvakitug Financial Considerations and Teva/Sanofi Alliance Key Terms
Duvakitug Financial Considerations Teva / Sanofi Alliance Key Terms • Development milestones to be recorded as Upfront signing $500 million in Q4 2023 revenues upon UC and CD Phase 3 initiations with $250 million each for UC and CD Phase 3 initiations: up to $600 million, including • Sanofi to lead
Slide 18: Meeting our commitments while funding growth
Meeting our commitments while funding growth Debt repayment and 1 net working capital enhancement Cash flow from operations Investment in our growth engines 2 (AUSTEDO®, AJOVY®, UZEDY®, etc.) Portfolio optimization Investment in R&D and 3 business development 18 |
Slide 19: Financial targets
Revenue growth % Operating Net debt/ adjusted Cash-to- (CAGR)1 income margin2,3 EBITDA2,3 earnings3,4,5 Mid-single 30% 2.0x 80% digit 1. CAGR = Compounded annual growth rate 2. Operating income margin = Non-GAAP operating income divided by net revenues; excluding potential impact of business develop
Slide 20: President and Chief Executive Officer
President and Chief Executive Officer
Slide 21: Return to growth, sustain growth, accelerate growth
2028+ 2025-2027 2023-2024 Sustain growth • Innovative launches Accelerate growth (duvakitug, anti-PD1-IL2, anti-IL15) Return to growth • Sustainable innovative pipeline • Innovative launches (olanzapine • AUSTEDO ‘24 revenues outlook LAI, ICS/SABA) • Focused business development of $1.6B • Biosimila
Slide 22: Deliver on growth engines, step up innovation, sustain generics, focus our business
Deliver on Step up Sustain generics Focus our growth engines innovation powerhouse business 22 |
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Slide 24: Met primary endpoints in UC and CD
UC: Met Primary Endpoint of Clinical Remission CD: Met Primary Endpoint Endoscopic Response (Modified Mayo Score; mMS) (SES-CD ≥ 50%) 27.4%a 34.8%a 60% 60% p=0.003 p<0.001 Participants Achieving Endpoint (%) 48% 48% Participants Achieving Endpoint (%) 50% 15.7%a 50% p=0.05 13.0%a 40% 36% 40% p=0.058
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