Item 7.01 Regulation FD Disclosure.
On September 19, 2022, Aurinia Pharmaceuticals Inc. (Aurinia or the Company)
announced that the European Commission (EC) has granted marketing authorization
of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a
serious complication of systemic lupus erythematosus (SLE). The U.S. Food and
Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination
with a background immunosuppressive therapy regimen to treat adult patients with
active LN. The centralized marketing authorization is valid in all European
Union (EU) member states as well as in Iceland, Liechtenstein, Norway and
As part of its December 2020 collaboration and licensing agreement with Otsuka
Pharmaceutical Co., Ltd., Aurinia will receive a $30.0 million approval-related
milestone payment to be recognized as revenue in the quarter, with receipt of
cash to follow within 30 days of invoicing.
The information in this Current Report on Form 8-K is being furnished and shall
not be deemed “filed” for the purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, or otherwise subject to the liabilities of that
section, nor shall they be deemed incorporated by reference into any of our
filings under the Securities Act of 1933, as amended, or the Securities Exchange
Act of 1934, as amended, whether made before or after the date hereof,
regardless of any general incorporation language in such filing. The furnishing
of this information hereby shall not be deemed an admission as to the
materiality of any such information.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain Officers.
Departure of Timothy P. Walbert from the Board of Directors
On September 19, 2022, Timothy P. Walbert, a member of the board of directors
(the Board) of Aurinia, notified the Company of his intent to resign from the
Board, effective at the close of business on September 19, 2022. Mr. Walbert’s
departure from the Board is not due to any disagreement with the Company or the
Board on any matter relating to the operations, policies or practices of the
Item 9.01 Financial Statements and Exhibits (d) Exhibits. Exhibit No. Description Cover Page Interactive Data File (the cover page XBRL tags are embedded within 104 the Inline XBRL document)
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