Item 2.02 Results of Operations and Financial Condition.
On October 11, 2022, Albireo Pharma, Inc. (the "Company") issued a press release
reporting positive topline results from the ASSERT trial, a global Phase 3
pivotal trial of Bylvay (odevixibat) in Alagille syndrome. A copy of the
Company's press release and a copy of the Company's presentation about the
ASSERT trial results are attached hereto as Exhibits 99.1 and 99.2,
respectively.
In the press release, the Company stated that it expects that sales of Bylvay
for the quarter ended September 30, 2022 will exceed $7 million. This statement
is incorporated by reference into this Item 2.02 of this Current Report on
Form 8-K, and shall not be deemed to be "filed" for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or
otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific
reference in such a filing.
Item 8.01 Other Events.
Except for the statement above regarding sales of Bylvay for the quarter ended
September 30, 2022, the information in the press release and the presentation
set forth in Exhibits 99.1 and 99.2, respectively, is incorporated by reference
into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number Description
99.1 Press release dated October 11, 2022.
99.2 Presentation on ASSERT topline data results.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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ALBIREO PHARMA, INC. 