| 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.