UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On January 13, 2025, Delcath Systems, Inc. (“Delcath”) issued a press release announcing preliminary financial results for the quarter ended and full year ended December 31, 2024 (the “Press Release”). A copy of the Press Release is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
| Item 7.01 | Regulation FD Disclosure. |
On January 13, 2025, Delcath made available an updated corporate presentation that may be used in connection with presentations at conferences and investor meetings, which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished as Exhibit 99.2 and incorporated by reference in this Item 7.01.
The information contained in this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On January 13, 2025, Delcath disclosed in the Corporate Presentation that as of December 31, 2024, (i) it had a total of 14 active sites utilizing HEPZATO KIT and (ii) there were approximately 36.2 million shares of its common stock issued and outstanding.
On January 13, 2025, Delcath also announced the following preliminary unaudited fourth quarter and full year 2024 financial and operational results:
| • | Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively |
| • | HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million, respectively |
| • | CHEMOSAT® fourth quarter and full year revenue expected to be approximately $1.4 million and $4.9 million, respectively |
| • | Gross margins expected to be in the 80%-85% range |
| • | $53.2 million of cash, cash equivalents and short term investments and no debt as of December 31, 2024 |
Delcath has not yet completed its financial close process for the fourth quarter and full year 2024 and, as a result, actual results may vary from the estimated preliminary results set forth in this Current Report on Form 8-K due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Delcath’s independent registered public accounting firm. These estimates should not be viewed as a substitute for Delcath’s full interim or annual audited financial statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release, dated January 13, 2025. | |
| 99.2 | Corporate Presentation, dated January 13, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Date: January 13, 2025 | By: | /s/ Gerard Michel | ||||
| Name: | Gerard Michel | |||||
| Title: | Chief Executive Officer | |||||