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 1.01 | Entry into a Material Definitive Agreement. |
On November 16, 2021, Mirum Pharmaceuticals, Inc. (the “Company”) entered into an asset purchase agreement (the “Agreement”) with Janssen Biotech, Inc. (“Buyer”), an affiliate of Johnson & Johnson, pursuant to which the Company agreed to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”) to Buyer. The Company was awarded the PRV by the U.S. Food and Drug Administration on September 29, 2021 in connection with the approval of LIVMARLI™ (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. Pursuant to the Agreement, Buyer agreed to pay the Company $110.0 million, payable in cash, upon the closing of the PRV purchase.
The Agreement contains customary representations, warranties, covenants and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
The foregoing description of the material terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Agreement, a copy of which is filed herewith as Exhibit 10.1 and incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K (this “Current Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the completion of the transactions contemplated by the Agreement. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the important factors discussed under the caption “Risk Factors” in the Company’s most recently filed Quarterly Report on Form 10-Q and the Company’s other filings with the Securities and Exchange Commission. Except as required by law, the Company undertakes no obligations to make any revisions to the forward-looking statements contained in this Current Report or to update them to reflect events or circumstances occurring after the date of this Current Report, whether as a result of new information, future developments or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1¥ | Asset Purchase Agreement, dated November 16, 2021, by and between the Registrant and Janssen Biotech, Inc. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
| ¥ | Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC. | |
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.
| Mirum Pharmaceuticals, Inc. | ||||||
| Date: November 19, 2021 | By: | /s/ Christopher Peetz | ||||
| Christopher Peetz | ||||||
| President and Chief Executive Officer | ||||||