2025-06-11-Jefferies-新阿姆斯特丹制药(NAMS)_研发日基本符合预期;市场需更多关注小LDL-P_14页_2mb
报告摘要
New Amsterdam Pharma (NAMS) Equity Research Summary
Rating & Target
- Rating: BUY
- Price Target: $45.00 (+120% from current price)
- Market Cap: $2.3B
Key Takeaways
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R&D Update:
- NAMS remains committed to using MACE-4 (including stroke) as the primary endpoint for the PREVAIL CVOT due to its broader clinical relevance and statistical advantages.
- BROADWAY trial data shows revascularization drove the majority of the MACE benefit, while CHD mortality improved over time. Stroke concerns (“wrong direction” in BROADWAY) may be overblown as revascularization has strong commercial drivers.
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Small LDL-P & Lp(a) Focus:
- Obicetrapib exhibits exceptional reduction in small LDL-P (knockdown >90%), distinguishing it from PCSK9 inhibitors and statins. This contributes significantly to MACE benefits.
- Small LDL-P and Lp(a) each contributed ≈5-6% points to BROADWAY’s 21% 1-year MACE benefit. Lp(a) reduction may account for 26% of the total effect, suggesting incremental +4-5% MACE benefit.
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MACE Benefit Projection:
- NAMS believes PREVAIL may achieve >20% MACE benefit (likely 21% at 1-year).
- A 20-30% all-cause mortality benefit could be substantial (HR 0.78-0.83 in BROADWAY), potentially triggering ethical early-stop in the trial if thresholds are reached.
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Investment Thesis:
- NAMS has a derisked pipeline for obicetrapib, with peak sales potential of $3-4B+ by 2026.
- Key catalysts: PREVAIL CVOT data (H2 2025), FDA filing (EMA by H2 2025), and follow-up Alzheimers data (AAIC Jul 28-Aug 1).
Valuation:
- PT $45: Based on probability-adjusted DCF model for obicetrapib, with minimal ascription to pipeline.
- Downside PT $5: Reflects failure scenarios (safety issues, endpoint misses).
Risks & Catalysts:
- Top Risks: Product quality/safety, pricing challenges, supply chain capacity.
- Catalysts:
- Jul 2025: Full AD data at AAIC.
- H2 2025: MRK PCSK9 phase III data, obicetrapib EMA submission.
- YE 2026: PREVAIL CVOT final primary analysis.
Long View:
- Where We Differ: Obicetrapib’s >90% small LDL-P knockdown places it above traditional CTT lines for cardiovascular MACE benefits.
- Upside Scenario: $60 PT based on higher probability of success and commercial go-forward.
- Downside Scenario: $5 PT assumes value loss from safety/regulatory risks or endpoint failures.
Analyst Disclaimers:
- Equity analysts certify fair compensation; report includes discretionary risk disclosures and Jefferies’ standard theatrical metrics.
- Content includes extensive conflicts of interest disclosures and non-binding ethics note regarding CVOT early stoppage.
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