诺华公司2021研发日会议报告-215页_30mb

Novartis R&D Day Summary (December 2, 2021)

Core Content

The Novartis R&D Day 2021 provided an overview of the company's strategy and growth story through 2030 and beyond. It emphasized a focused medicines company model, driven by technological leadership, world-class commercialization, global access, and data science. The agenda covered several therapeutic areas, including Cardiovascular and Renal, Immunology, Hepatology & Dermatology, Neuroscience, Oncology, NIBR and Technology Platforms, with additional details on Respiratory & Allergy, submission schedules, and references.

Key Takeaways

• Strategy Overview: Novartis aims to be a focused medicines company, leveraging innovation and technology platforms to drive growth and maintain leadership in ESG factors.
• Growth Timeline:
  • 2020–2026: Targeting a CAGR of 4% or more, with a focus on core therapeutic areas and the pipeline.
  • 2026–2030: Double-down on internal pipeline assets to unlock their potential and add complementary BD&L.
  • 2030 and beyond: Focused investments in technology platforms while staying at the forefront of innovation in small and large molecules.
• Key Aspirations:
  • Innovation power
  • Top 3 innovator
  • High 30s IM margin, attractive ROIC
  • Consistent above peer median growth
  • Global leader in material ESG factors

Therapeutic Areas

Cardiovascular and Renal

• Leqvio® is on track for US launch with an FDA action date of January 1, 2022. It is expected to address hyperlipidemia and CVRR-LDLC.
• Iptacopan is in Phase 3 trials for IgAN and C3G, with submissions expected in 2023.
• Pelacarsen is in Phase 3 for CVRR-Lp(a), with submission in 2025.
• Entresto is expected to face generic competition, but significant potential sales remain post-genericization.

Immunology, Hepatology & Dermatology

• Cosentyx is in Phase 3 for HS and GCA, with submissions expected in 2022 and 2024 respectively.
• Ligelizumab is in Phase 3 for CSU and food allergy, with submissions expected in 2022 and 2025.
• Remibrutinib is in Phase 3 for multiple sclerosis, with submissions expected in 2024 and 2025.
• Ianalumab is in Phase 3 for Sjögren's and SLE, with submissions expected in 2026.
• Iscalimab is in Phase 2 for liver transplant and HS, with submissions expected in 2026.

Neuroscience

• Zolgensma is in Phase 3 for SMA IT, with submission in 2025.
• Branaplam is in Phase 2b for Huntington's disease, with submission in 2026.
• Remibrutinib is in Phase 3 for multiple sclerosis, with submission in 2025.

Oncology

• SCEMBLIX® is approved for 3L CML and CML patients with T315I mutation.
• Lu-PSMA-617 is in registration for mCRPC post-taxane, mCRPC pre-taxane, and mHSPC, with submissions expected in 2023, 2024, and 2026.
• Kisqali is in Phase 3 for HR+/HER2- BC (adj), with submission in 2023.
• Canakinumab is in Phase 3 for NSCLC adjuvant, with submission in 2023.
• JDQ443 KRAS inhibitor is in Phase 3 for 2/3L NSCLC (mono), with submission in 2024.
• TNO155 SHP2 inhibitor is in ongoing trials for multiple combinations in solid tumors.
• Tislelizumab is in registration for 2L esophageal cancer and NSCLC, with submission in 2023 and 2026.

Technology Platforms

• Targeted Protein Degradation (TPD): Advancing a broad portfolio of NMEs.
• Radioligand Therapy (RLT): Expanding across additional solid tumors.
• siRNA: Fully building up capabilities for future therapies.
• xRNA: Exploring next wave of assets with high unmet need.

Capital Allocation

• Disciplined Approach: Focused on core therapeutic areas and key growth brands.
• Dividend Growth: Commitment to maintain a growing dividend, with a CAGR of 7.8% in CHF and 9.8% in USD between 1996–2020.
• M&A Activities: Value-creating bolt-ons totaling ~USD 29bn since 2018.
• Share Buybacks: ~USD 12bn over the past 5 years.

Geographical Diversification

• US: Low exposure to US pricing reforms, with Leqvio® launch preparations ongoing.
• EU: Maintaining sales leadership.
• China: Sales on track to double by 2024.
• RoW: Approved in 50 countries, with reimbursement reviews in >10 markets.
• UK: NHS population health agreement to treat ~300k ASCVD patients.

Growth Drivers

• Pipeline Assets: 20 potential billion-USD+ assets with approval by 2026, most supported by strong evidence.
• Generic Erosion Gap: Estimated USD 9bn gap from new generic entries through 2026.
• Pipeline Impact: Probabilized pipeline sales and Entresto LoE forecast assumptions could lead to sales growth of 4%+ through 2026.

Risks and Uncertainties

• Forward-Looking Statements: Subject to risks including liquidity disruptions, regulatory delays, data security breaches, and uncertainties in clinical trial results.
• Global Trends: Impact of healthcare cost containment, pricing pressures, and pandemics like COVID-19.
• Market Dynamics: Erosion curves vary by geography, with significant potential sales for major brands post-genericization.

Conclusion

Novartis remains committed to driving consistent growth through 2030 and beyond by focusing on core therapeutic areas, advancing technology platforms, and maintaining a strong geographic presence. The company's innovative pipeline and strategic initiatives are expected to mitigate the impact of generic competition and deliver high-value assets to the market.