UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 19, 2018

ALBIREO PHARMA, INC.

(Exact name of registrant as specified in its charter)

(857) 254-5555

Registrant’s telephone number, including area code

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 2.02 Results of Operations and Financial Condition.

On January 19, 2018, Albireo Pharma, Inc. (the “Company”) issued a press release announcing among other things that Japan’s Ministry of Health, Labour and Welfare (“MHLW”) has approved the new drug application for elobixibat for the treatment of chronic constipation in Japan (the “Elobixibat Japan Approval Release”). In the Elobixibat Japan Approval Release, the Company disclosed that, at December 31, 2017, the Company had approximately $53.5 million in cash and cash equivalents. This amount is preliminary, unaudited and subject to the completion of the audit of the Company’s consolidated financial statements as of and for the year ended December 31, 2017 (the “Audited 2017 Financial Statements”). As a result, this amount may differ from the amount that will be reflected in the Audited 2017 Financial Statements. Additional information and disclosures are required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2017.

Item 8.01 Other Events.

On January 24, 2018, the Company issued a press release (the “Offering Release”) announcing the commencement of an underwritten public offering of its common stock pursuant to a shelf registration statement on Form S-3 (File No. 333-220958) declared effective by the Securities and Exchange Commission on December 5, 2017. In connection with the offering, the Company also announced its intention to grant the underwriters an option for a period of up to 30 days to purchase up to an additional 15% of the number of shares of common stock sold in the offering on the same terms and conditions. The Elobixibat Japan Approval Release and the Offering Release are attached hereto as Exhibits 99.1 and 99.2, respectively, and incorporated by reference in this Item 8.01.

On January 24, 2018, the Company filed with the Securities and Exchange Commission a preliminary prospectus supplement to its effective shelf registration statement on Form S-3 pursuant to Rule 424 under the Securities Act of 1933, as amended (the “Securities Act”), relating to the proposed public offering of shares of the Company’s common stock noted above. The preliminary prospectus supplement contains an updated summary description of the Company’s business in the section entitled “Prospectus Supplement Summary,” which is attached hereto as Exhibit 99.3 and incorporated herein by reference, and contains supplemental risk factors in the section entitled “Risk Factors,” which is attached hereto as Exhibit 99.4 and incorporated herein by reference.

This Current Report on Form 8-K, including the exhibits hereto, shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, which is being made only by means of a written prospectus meeting the requirements of Section 10 of the Securities Act, nor shall there be any sale of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

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.