I realize this thread has gotten long.
So here is a summary:
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CLEAR Outcomes Trial (2023–2024)
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Mar 2023: Topline results — 13% MACE-4 reduction.
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Late 2023: Full data presented.
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Mar 2024: U.S. label update — CV risk reduction.
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Aug 2025: ESC/EAS Level 1a recommendation.
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Commercial Progress (U.S.)
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2020: Initial launch (LDL-C only).
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2024–2025: Post-label growth +42% H1 2025 prescriptions.
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Payer access: >90% commercial, >80% Medicare.
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Dec 2025: ACC PAD/Diabetes statement — first-line for LDL-C + limb benefits.
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Global Expansion & Tech Transfer
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Europe (Daiichi Sankyo): NILEMDO/NUSTENDI since 2020; Jan 2024 tech transfer announced — DSE assumes manufacturing responsibility (reduces Esperion COGS long-term).
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Japan (Otsuka): Nov 2025 launch + $90M milestone; future manufacturing transition expected (similar cost relief).
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Inventory build: Q3 2025 ~$108M net (up from $94M YE2024) — proactive scaling for U.S. demand + partner supply agreements; expected drawdown post-transfers (lower COGS 2027+).
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Cost Optimizations / OpEx
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OpEx trajectory: ~$160M annual run-rate 2024–2025; assumption cap $300M total (SG&A + R&D + COGS) from 2026 (breakeven inflection).
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Tech transfers (Europe 2024, Japan future): Shift manufacturing burden to partners → COGS reduction ~$20–40M/year long-term.
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Inventory management: Build for growth/partner bulk sales; post-transfer → lower carrying costs, improved margins.
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IP / Exclusivity
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ANDA settlements 2025: Generics barred to April 2040.
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Alkem litigation ongoing.
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Japan patent granted 2025: Triple combo protection.
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Debt / Balance Sheet
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June 2024: $304.7M OMERS DSE royalty sale.
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Dec 2024: $150M Athyrium loan + $100M 2030 converts.
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Nov 2025: $55M 2025 notes paid off.
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Current debt: $250M.
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Cash ~$197M; runway 2027+.
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Dilution Summary
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Shares basic: ~118M YE2023 → ~195M YE2024 → ~205M Q3 2025.
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Major: Jan 2024 30M offering; Oct 2025
30M shares ($70M net). -
Fully diluted: ~275M (warrants 26M @ $1.55, 2030 converts 32M, options/RSUs ~17M).
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Forward expectation: Minimal new dilution post-2026 (FCF covers ops); potential warrant exercises cash-accretive.
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Investor Communications (Outside Quarterly ERs)
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Apr 2025: R&D Day (pipeline focus, ESP-2001 nomination).
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Jan 2025: JP Morgan Healthcare Conference presentation.
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Nov 2025: Jefferies London Healthcare Conference (CFO remarks on debt payoff).
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Regular: Firesides at Cowen, Cantor, Needham (2024–2025 dates scattered Q1–Q3).
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Bempedoic Acid Additional Data
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2022: Preclinical ADPKD cyst inhibition.
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2025: AHA — VTE/monotherapy subsets.
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Dec 2025: ACC PAD limb benefits.
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Next-Gen ACLY Pipeline
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Apr 2025: R&D Day — ESP-2001 PSC nomination.
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Oct 2025: IND-enabling PSC; goal IND 2026.
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Kidney: Preclinical 2022 + Phase 2 completed; BEAT-PKD (DoD) not yet recruiting.
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Oncology: No direct activity (Espervita separate).
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Current Snapshot (Dec 19, 2025)
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Market cap ~$900M.
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Breakeven 2026 trajectory.
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Triple combo development ongoing.
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