Delcath Systems Announces Preliminary Third Quarter 2024 Revenue Results
October 17 2024 - 8:30AM
Business Wire
$10 Million Quarterly U.S. Revenue Triggers
$25 Million Financing Tranche
Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the
“Company”), an interventional oncology company focused on the
treatment of primary and metastatic cancers of the liver, today
announced preliminary revenue results for the third quarter of
2024, achieving $11.2 million, which included the recording of
$10.0 million in U.S. revenue from the commercialization of HEPZATO
KIT.
The announcement of the recording of $10.0 million in U.S.
quarterly revenue from the commercialization of HEPZATO KIT
effectively triggers the exercise of Tranche B warrants issued in
the previously announced March 29, 2023 Private Investment in
Public Equity (the “PIPE”). Holders of the Tranche B warrants from
the PIPE have 21 days from the date of this announcement to
exercise their Tranche B warrants to purchase shares of common
stock at an effective price of $6.00 per share of common stock for
an aggregate exercise price of up to approximately $25 million.
“This revenue milestone is an important indicator of the strong
demand for HEPZATO KIT, highlighting the unmet medical need it
addresses in uveal melanoma patients with liver metastases and the
rapid uptake by physicians,” said Gerard Michel, Chief Executive
Officer of Delcath. “The Company will utilize the additional $25
million of financing to support the ongoing commercial launch and
invest in new clinical trials to expand indications which we plan
to initiate in 2025.”
Final financial results for the third quarter and a detailed
business update will be provided during Delcath’s quarterly
financial results release and investor call scheduled for November
8, 2024.
About Delcath 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.
Financial Disclaimer
Delcath has not completed preparation of its financial
statements for the third quarter of 2024. Delcath is in the process
of completing its customary quarter-end close and review procedures
as of and for the quarterly period ended September 30, 2024, and
there can be no assurance that final results for this period will
not differ from these estimates.
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 press release 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, potential proceeds from exercise
of the Tranche B warrants; uncertainties relating to: the Company's
commercialization 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 and assemble 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 Mitigation Strategy; 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
successfully enter 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 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, 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 publicly update or revise
these forward-looking statements to reflect events or circumstances
after the date they are made.
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version on businesswire.com: https://www.businesswire.com/news/home/20241017610926/en/
Investor Relations: ICR Healthcare
investorrelations@delcath.com
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