Business Context and Reporting Period
This Form 8-K Current Report was filed by Akebia Therapeutics, Inc. on February 17, 2021, covering events occurring on February 10 and February 11, 2021. The report details the entry into material definitive agreements regarding the commercial manufacturing and supply of the Company's drug products, vadadustat and Auryxia.
Key Financial Metrics
This filing is a Current Report (Form 8-K) and does not contain financial statements, revenue, profit, cash flow, margin, debt, or liquidity metrics. The document focuses exclusively on contractual agreements.
Material Changes and Agreements
Supply Agreement with WuXi STA for Vadadustat
- Counterparty: STA Pharmaceutical Hong Kong Limited (WuXi STA), a subsidiary of WuXi AppTec.
- Product: Vadadustat drug product for commercial purposes.
- Term: Initial term of four years (February 10, 2021 to February 10, 2025), renewable by mutual agreement.
- Pricing: Volume-based structure; fixed for the first 12 months, then annually reviewed.
- Commitments: Akebia agreed to purchase a certain percentage of global demand from WuXi STA and will provide rolling quarterly forecasts.
- Termination: Akebia may terminate for any reason with 180 days' prior written notice.
- Context: This agreement complements an existing supply agreement with Patheon Inc. and prior agreements for drug substance manufacturing with Esteve Quimica, S.A. and WuXi STA.
Amendment No. 3 to Agreement with Siegfried for Auryxia
- Counterparty: Siegfried Evionnaz SA (Siegfried).
- Product: Auryxia drug substance for commercial purposes.
- Change: Extension of the agreement term for one manufacturing site.
- New Term: Expires December 31, 2022, with an option to extend through December 31, 2023 upon 12 months' notice.
- Commitments: Includes minimum annual quantity commitments and predetermined prices for the remainder of the term.
Guidance, Outlook, and Risks
The filing does not provide updated financial guidance or management commentary on future performance. The agreements include customary indemnification, intellectual property protection, and quality requirements. The Company expects to file the full text of the WuXi STA Supply Agreement as an exhibit to its Form 10-Q for the quarter ending March 31, 2021, and the Siegfried Amendment as an exhibit to its Form 10-K for the fiscal year ended December 31, 2020.
Investor Verification Checklist
- Verify the specific percentage of global vadadustat demand committed to WuXi STA, as the filing states "a certain percentage" without specifying the number.
- Review the full text of the WuXi STA Supply Agreement and Siegfried Amendment once filed as exhibits to the Form 10-Q and Form 10-K, respectively, for detailed pricing and termination clauses.
- Confirm the status of the existing supply agreement with Patheon Inc. to understand the total manufacturing capacity allocation for vadadustat.
- Monitor the Company's quarterly forecasts to WuXi STA to gauge commercial launch expectations for vadadustat.