8-K
Delcath Systems, Inc. (DCTH)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): May 22, 2025
DELCATH SYSTEMS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-16133 | 06-1245881 |
|---|---|---|
| (State or other jurisdiction of<br> <br>incorporation or organization) | (Commission<br> <br>File Number) | (IRS Employer<br> <br>Identification No.) |
566 Queensbury Avenue
Queensbury, NY 12804
(Address of principal executive offices) (Zip Code)
(518) 743-8892
(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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br> <br>symbol(s) | Name of each exchange<br> <br>on which registered |
|---|---|---|
| Common Stock, $.01 par value | DCTH | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 7.01 Regulation FD Disclosure.
On May 22, 2025, Delcath Systems, Inc. (“Delcath”) issued a press release announcing 2025 full year guidance. A copy of the press release is furnished pursuant to Item 7.01 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information furnished pursuant to this Item 7.01 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 liability of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On May 22, 2025, Delcath announced that it plans to enter into a National Medicaid Drug Rebate Agreement (the “NDRA”) with the Centers for Medicare & Medicaid Services and that it expects the NDRA to take effect at the beginning of the third quarter of 2025.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This Form 8-K contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to Delcath’s ability to successfully enter into the NDRA and its potential impact Delcath’s business and operations. For additional information and other factors that may impact Delcath, please see Delcath’s other filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, investors should not place undue reliance on these forward-looking statements, which speak only as of this Current Report on Form 8-K. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated May 22, 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: May 22, 2025 | By: | /s/ Sandra Pennell |
| Name: Sandra Pennell | ||
| Title: Chief Financial Officer |
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EX-99.1
Exhibit 99.1
Delcath Systems Issues Full Year 2025 Guidance
2025 Full Year Total Revenue Guidance of $94 to $98 million
Delcath Announces Plan to Enter into National Medicaid Drug Rebate Agreement
QUEENSBURY, NY – May 22, 2025, Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced full year 2025 financial guidance and its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access.
2025 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2025 is as follows:
| • | Total CHEMOSAT and HEPZATO KIT revenue of $94 to $98 million, an increase of more than 150% over 2024<br> |
|---|---|
| • | Gross margins between 83% to 85% |
| --- | --- |
| • | Positive adjusted EBITDA and cashflow in each quarter of 2025 |
| --- | --- |
National Medicaid Drug Rebate Agreement
Delcath will participate in the Medicaid Drug Rebate Program, which entails providing Medicaid rebates and 340B discounts to eligible entities. The Company has initiated the process of entering into the NDRA with the Centers for Medicare and Medicaid Services and expects it to take effect at the beginning of the third quarter of 2025.
“Our decision to enter into the NDRA simplifies Medicaid access and enables eligible hospitals to access 340B drug pricing. We believe this will expand treatment availability and accelerate adoption of HEPZATO in the United States,” said Gerard Michel, Chief Executive Officer of Delcath. “Based on current center activation rates and rising utilization, we expect total HEPZATO treatment volume in 2025 to increase at least 200% versus 2024.”
AboutDelcath Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT^™^ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT^®^ Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.
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Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This pressrelease contains forward-looking statements, including the Company’s 2025 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,”“should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that maycause such differences include, but are not limited to, uncertainties relating to: the Company’s ability to successfully enter into the NDRA and its potential impact on the Company’s business and operation; the Company’scommercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture andassemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and MitigationStrategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfullyenter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and ExchangeCommission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time totime, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publiclyupdate or revise these forward-looking statements to reflect events or circumstances after the date they are made.
Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com
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