8-KAccepted Sep 8, 4:54 PM ET
Amylyx Pharmaceuticals Signs Manufacturing Supply Deals with Bachem & Polypeptide
Accepted (ET)
4:54 PM
Sep 8, 2026
Filed
Sep 8, 2026
Documents
11
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147.0 KB
Summary
Amylyx Pharmaceuticals Signs Manufacturing Supply Deals with Bachem & Polypeptide
What Happened
Amylyx Pharmaceuticals announced on Sept. 1 and Sept. 8, 2026, that it has entered agreements with Polypeptide Group AG (term sheet dated Sept. 1) and Bachem Americas, Inc. (Manufacturing and Supply Agreement dated Sept. 8) to supply avexitide drug substance for commercial use if approved. Both providers will be non‑exclusive suppliers and Amylyx may use additional manufacturers.
Key Details
- Polypeptide: Amylyx signed a term sheet and agreed to pay a $30 million upfront fee to reserve capacity; parties will negotiate a definitive Polypeptide Manufacturing Agreement. Under the term sheet, minimum annual purchases begin in 2028 and pricing is fixed by volume and may be adjusted annually.
- Bachem: The Bachem Manufacturing Agreement (effective Sept. 8, 2026) includes minimum annual purchase commitments starting in 2028, annual price adjustments effective Jan. 1 to reflect labor/utilities/overhead, and additional maintenance fees. Initial term is five years, with automatic three‑year renewals unless terminated per contract terms.
- Both agreements: Suppliers are non‑exclusive; Amylyx must provide periodic supply estimates (some portions binding); contracts include customary provisions on quality, testing, IP ownership, audits, confidentiality, indemnification and termination for breach, insolvency or certain regulatory actions.
- Documentation: Full agreements will be filed as exhibits to Amylyx’s Form 10-Q for the quarter ending Sept. 30, 2026.
Why It Matters
These agreements aim to secure long‑term manufacturing capacity for avexitide if it receives regulatory approval, reducing single‑source supply risk by engaging multiple suppliers. The $30 million capacity reservation with Polypeptide and minimum purchase commitments (starting 2028) create potential cash and contractual obligations that investors should monitor as product commercialization and regulatory milestones proceed. The contracts also include price‑adjustment mechanisms and standard termination and quality provisions that affect supply cost, flexibility, and operational risk.