| Item 1.01 |
Entry into a Material Definitive Agreement. |
On October 29, 2025, Savara Inc. (the “Company”) announced its entry into a purchase and sale agreement (the “Purchase Agreement”) with funds managed by RTW Investments, LP (the “Purchaser”). Under the terms of the Purchase Agreement, the Purchaser has agreed to pay the Company $75 million (the “Purchase Price”) upon approval of the Company’s investigational inhaled biologic, molgramostim inhalation solution (“MOLBREEVI”), for the treatment of autoimmune pulmonary alveolar proteinosis (“autoimmune PAP”) by the FDA on or before March 31, 2027 and subject to satisfaction of other customary closing conditions, in exchange for a true sale of assigned interests, including the right to receive royalty payments equal to a percentage of Net Sales (as defined in the Purchase Agreement) of MOLBREEVI in the U.S. The royalty rate is tiered, with the payments ranging from 7.0% to 1.0% of Net Sales in each calendar year, with the 7.0% tier increasing to 9.5% for a calendar year if the prior year’s Net Sales do not achieve a specified level. The royalty payments commence in the first calendar quarter in which there is a commercial sale of MOLBREEVI in the U.S. and end upon the receipt by the Purchaser of $187.5 million (the “Maximum Payment”). Based on the Company’s current projections, the Company expects the effective royalty rate over the life of the Purchase Agreement will be in the low-single digits. The Purchase Agreement includes a buy-back option that may allow the Company to pay a specified amount up to the Maximum Payment to terminate the Purchase Agreement and all obligations in the event of certain changes of control within two years of receipt of the Purchase Price. Unless otherwise agreed with the Purchaser, the Company is required to use a portion of the Purchase Price to repay all outstanding indebtedness.
The Purchase Agreement contains customary affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness (which restrictions are eliminated after the achievement by the Company of a specified amount of Net Sales), and other provisions customary for transactions of this nature, in each case subject to certain exceptions set forth in the Purchase Agreement.
The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which will be included as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2025 to be filed with the Securities and Exchange Commission (the “SEC”).
| Item 7.01 |
Regulation FD Disclosure. |
On October 29, 2025, the Company issued a press release announcing the Purchase Agreement described above. A copy of the press release is furnished as Exhibit 99.1 and incorporated herein by reference.
The information contained under Item 7.01 of this Current Report on Form 8-K (this “Current Report”) (including Exhibit 99.1), shall not be deemed “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 may be expressly set forth by specific reference in such filing.
Corporate Presentation
An abbreviated version of the Company’s corporate presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein. The Company undertakes no duty or obligation to update or revise the information contained in this presentation, although it may do so from time to time. Any such updates may be made through the Investor Relations page of the Company’s website, the filing of other reports or documents with the SEC, press releases, or other public disclosure.
Litigation
On September 8, 2025, a stockholder filed putative securities class action claims against the Company and certain of our executive officers in the United States District Court for the Eastern District of Pennsylvania, purportedly on behalf of classes of the Company’s investors who purchased or otherwise acquired the Company’s common stock and securities between March 7, 2024 and May 23, 2025. The complaint alleges violations of various sections of the Exchange Act and Rule 10b-5 promulgated thereunder in connection with various public statements made by the Company regarding its regulatory filings for MOLBREEVI as a therapy to treat patients with