Follow-On Public Offering
On August 9, 2022, Mirum Pharmaceuticals, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC, SVB Securities LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale in a public offering of 3,478,261 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”). The price to the public in the offering was $23.00 per share. The gross proceeds to the Company from the offering are expected to be $80.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The closing of the offering is expected to occur on August 12, 2022, subject to the satisfaction of customary closing conditions. In addition, the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to 521,739 additional shares of Common Stock at the public offering price, less the underwriting discounts and commissions.
The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by such parties.
The offering is being made pursuant to an effective registration statement on Form S-3 and accompanying prospectus (File No. 333-240290), previously filed with the Securities and Exchange Commission (the “SEC”), and a prospectus supplement thereunder. A copy of the Underwriting Agreement is filed as Exhibit 1.1 to this report, and the foregoing description of the terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit. A copy of the opinion of Cooley LLP relating to the legality of the issuance and sale of the shares in the offering is attached as Exhibit 5.1 hereto.
Company Overview
In connection with the offering described above, the Company provided the following updated overview.
The Company is a biopharmaceutical company focused on the identification, acquisition, development and commercialization of novel therapies for debilitating rare and orphan diseases. It focuses on diseases for which the unmet medical need is high and the biology for treatment is clear.
The Company’s lead product LIVMARLI® (maralixibat) oral solution (“Livmarli”), a novel, oral, minimally-absorbed agent designed to selectively inhibit apical sodium bile acid transporter (“ASBT”), also known as the ileal bile acid transporter (“IBAT”), is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (“ALGS”) one year of age and older in the United States. The Company markets and commercializes Livmarli in the United States through its specialized and focused commercial team. The Company believes the initial addressable patient population in the United States is approximately 2,000 to 2,500 pediatric ALGS patients, which, based on its current expectations and beliefs, represents a greater than $500.0 million market opportunity. The Company has also filed for approval in Europe of Livmarli for the treatment of cholestatic liver disease in patients with ALGS and plans to commercialize Livmarli in Western Europe with its international team based in Switzerland. The Company has entered into license and distribution agreements with several rare disease companies for the commercialization of Livmarli in additional countries.
The Company is also developing Livmarli for progressive familial intrahepatic cholestasis (“PFIC”) and biliary atresia (“BA”). Livmarli has been granted breakthrough designation for ALGS and PFIC type 2. It expects to report topline data from its MARCH-PFIC Phase 3 clinical trial in the fourth quarter of 2022 and topline data from its EMABARK Phase 2b clinical trial in BA in the second half of 2023.
The Company is advancing its second product candidate, volixibat, a novel, oral, minimally-absorbed agent designed to inhibit IBAT, for the treatment of adult patients with cholestatic liver diseases. It is developing volixibat for the treatment of intrahepatic cholestasis of pregnancy (“ICP”), primary sclerosing cholangitis (“PSC”) and
