Akebia Therapeutics Terminates Vifor Pharma Agreement

TL;DR

Akebia ditches Vifor Pharma deal for vadadustat.

AI Summary

On July 10, 2024, Akebia Therapeutics, Inc. announced the termination of its Material Definitive Agreement with Vifor Pharma Group. This termination is related to the royalty-free, non-exclusive, worldwide license agreement for vadadustat, a drug used to treat anemia due to chronic kidney disease.

Why It Matters

This termination could significantly impact Akebia's strategic partnerships and future revenue streams related to vadadustat, potentially requiring a reassessment of its commercialization strategy.

Risk Assessment

Risk Level: medium — The termination of a material agreement with a key partner like Vifor Pharma introduces uncertainty regarding future revenue and strategic direction.

Key Players & Entities

• Akebia Therapeutics, Inc. (company) — Registrant
• Vifor Pharma Group (company) — Partner in terminated agreement
• vadadustat (drug) — Subject of the license agreement
• July 10, 2024 (date) — Date of the termination event

FAQ

Key Financial Figures

• $0.00001 — ich registered Common Stock, par value $0.00001 per share AKBA The Nasdaq Capital Marke
• $40 million — icense Agreement, CSL Vifor contributed $40 million to a working capital facility (the "Wor
• $40 m — otal of the WCF Royalty Payments equals $40 million, or (ii) May 31, 2028 (the "WCF R
• $10 m — ubject to minimum true-up milestones of $10 million, $20 million and $40 million (eac
• $20 million — imum true-up milestones of $10 million, $20 million and $40 million (each, a "WCF Royalty T
• $450 million — the Company's net sales of Vafseo up to $450 million to mid-single digit percentage of the C
• $450 m — the Company's net sales of Vafseo above $450 million, in each case, in the Territory d
• $55.0 million — the aggregate principal amount of up to $55.0 million. The Amendment includes certain covenan

Filing Documents

• akba-20240710.htm (8-K) — 34KB
• 0001517022-24-000061.txt ( ) — 172KB
• akba-20240710.xsd (EX-101.SCH) — 2KB
• akba-20240710_def.xml (EX-101.DEF) — 4KB
• akba-20240710_lab.xml (EX-101.LAB) — 24KB
• akba-20240710_pre.xml (EX-101.PRE) — 14KB
• akba-20240710_htm.xml (XML) — 3KB

01. Entry into a Material Definitive Agreement

Item 1.01. Entry into a Material Definitive Agreement. CSL Vifor Termination and Settlement Agreement On July 10, 2024, Akebia Therapeutics, Inc. (the "Company") and Vifor (International) Ltd. (now a part of CSL Limited) ("CSL Vifor") entered into a Termination and Settlement Agreement (the "Termination Agreement"). Pursuant to the Termination Agreement, the Company and CSL Vifor agreed, among other things, to terminate, effective immediately, the Second Amended and Restated License Agreement, dated February 18, 2022 and as amended May 3, 2024 (the "License Agreement"), pursuant to which the Company granted to CSL Vifor an exclusive license to sell Vafseo to Fresenius Medical Care North America and its affiliates, including Fresenius Kidney Care Group LLC , to certain third-party dialysis organizations approved by the Company, to independent dialysis organizations that are members of certain group purchasing organizations, and to certain non-retail specialty pharmacies (the "Supply Group") in the U.S. (the "Territory"). The parties agreed to terminate the License Agreement for business reasons. Under the License Agreement, CSL Vifor contributed $40 million to a working capital facility (the "Working Capital Fund") established to partially fund the Company's costs of purchasing Vafseo from its contract manufacturers. Pursuant to the terms of the Termination Agreement, and generally consistent with the terms of the License Agreement, the Company will repay the Working Capital Fund to CSL Vifor through quarterly tiered royalty payments ranging from 8% to 14% of the Company's net sales of Vafseo in the Territory (the "WCF Royalty Payments"). The WCF Royalty Payments will commence on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $40 million, or (ii) May 31, 2028 (the "WCF Royalty Term"). The WCF Royalty Payments are subject to minimum true-up milestones of $10 million, $20 million and $40 million (e

02. Termination of a Material Definitive Agreement

Item 1.02. Termination of a Material Definitive Agreement. The information contained in Item 1.01 of this Current Report on Form 8-K under the heading "CSL Vifor Termination and Settlement Agreement" is incorporated by reference herein and made a part hereof. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. AKEBIA THERAPEUTICS, INC. Date: July 11, 2024 By: /s/ John P. Butler Name: John P. Butler Title: President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR