UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 2.05 | Costs Associated with Exit or Disposal Activities. |
On November 7, 2022, the Board of Directors of Akebia Therapeutics, Inc. (the “Company”) approved a reduction of the Company’s workforce by approximately 14% consisting solely of individuals within the commercial organization of the Company as a result of the Company’s decision to shift to a strategic account management focused model for its commercial efforts. This shift is due to multiple factors, including the maturity of the Company’s commercial product, Auryxia®, the continued impact of the COVID-19 pandemic on dialysis centers and the phosphate binder market and that, if the Company is successful in its appeal of the complete response letter for vadudustat with the U.S. Food and Drug Administration, the Company’s commercial focus for vadadustat will be limited to the dialysis patient population. This shift in approach supports the Company’s strategic pillars to drive Auryxia revenue while also continuing to decrease operating costs. This is consistent with the Company’s plan to fund operations with existing cash resources and cash from operations. This workforce reduction is expected to be substantially completed by the end of the fourth quarter of 2022.
Affected employees will be offered separation benefits, including severance payments, healthcare coverage and related benefits. The Company expects to record a restructuring charge of approximately $1.8 million primarily related to one-time and contractual termination benefits including severance, non-cash stock-based compensation expense, healthcare and related benefits in the fourth quarter of 2022. The Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction. The charge that the Company expects to incur in connection with the workforce reduction is an estimate and subject to a number of assumptions, and actual results may differ materially.
Forward-Looking Statements
Statements in this Current Report on Form 8-K regarding the Company’s strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: the Company’s workforce reduction, future charges expected to be incurred in connection therewith, the Company’s appeal of the complete response letter for vadadustat, including expectations regarding the commercial focus for vadadustat if approved, the Company’s ability to support its strategic pillars and the Company’s plan to fund operations with existing cash resources and cash from operations. The terms “believe,” “expect,” “potential,” “will,” “continue,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the Company’s ability to successfully implement its workforce reduction plan and reduce expenses; the impact of the workforce reduction on the Company’s business; the ability of the Company to attract and retain qualified personnel; decisions made by health authorities, such as the U.S. Food and Drug Administration and the European Medicines Agency, with respect to regulatory filings; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia, including potential generic entrants; the direct or indirect impact of the COVID-19 pandemic on regulators and the Company’s business, operations, and the markets and communities in which the Company and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of the Company’s collaborations. Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and other filings that the Company may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this Current Report on Form 8-K, and, except as required by law, the Company does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this Current Report on Form 8-K.
SIGNATURES
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: November 8, 2022 | By: | /s/ John P. Butler | ||||
| Name: | John P. Butler | |||||
| Title: | President and Chief Executive Officer | |||||