Delcath Systems Reports First Quarter 2024 Results and Business Highlights
Conference Call Today at
Recent Business Highlights
During and since the first quarter,
- Recognized over
$2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and$1.1 million in CHEMOSAT sales throughMarch 31, 2024 ; - Updated
U.S. center activation guidance from 15 active centers to a total of 20 active centers by the end of 2024; - Activated four treating centers during the first quarter with an additional two centers in April. A further five centers are accepting patient referrals in anticipation of activation;
- Raised
$7.0 million in a private placement transaction with certain accredited investors comprised of existing investors,Delcath senior executives, and members of its Board of Directors; - Appointed
Martha S. Rook , Ph.D, an experienced industry leader with more than 25 years of academic and industry experience, as Chief Operating Officer; - Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from the
Centers for Medicare & Medicaid Services (CMS) which became effective onApril 1, 2024 ; - Executed an amendment with
Synerx Pharma, LLC andMylan Teoranta forDelcath's supply of melphalan hydrochloride which extends the term of the original agreement toDecember 31, 2028 ; and - Announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma on
May 4, 2024 , in the journal Annals of Surgical Oncology.
"We continue to make steady progress in the training and activation of new treatment centers which is a testament to both the emerging role of HEPZATO in the treatment of patients with metastatic uveal melanoma and the capability and dedication of our field force," said
First Quarter 2024 Results
Cash, cash equivalents and investment totaled
Total revenue for the quarter ended
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Conference Call Information
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Time: |
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Participant Numbers |
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1-833-630-1960 |
International: |
1-412-317-1841 |
Webcast: |
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Conference Replay |
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US Toll Free: |
1-877-344-7529 |
International Toll: |
1-412-317-0088 |
Replay Access Code: |
9490444 |
End Date: |
May 21, 2024 |
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
In
In
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, 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
Investor Relations Contact:
investorrelations@delcath.com
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Condensed Consolidated Balance Sheets |
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(Unaudited) |
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(in thousands, except share and per share data) |
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Assets |
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Current assets |
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Cash and cash equivalents |
$ 11,760 |
$ 12,646 |
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Restricted cash |
50 |
50 |
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Short-term investments |
15,360 |
19,808 |
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Accounts receivable, net |
1,564 |
241 |
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Inventory |
3,634 |
3,322 |
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Prepaid expenses and other current assets |
1,278 |
1,091 |
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Total current assets |
33,646 |
37,158 |
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Property, plant and equipment, net |
1,336 |
1,352 |
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Right-of-use assets |
1,117 |
103 |
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Total assets |
$ 36,099 |
$ 38,613 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
$ 1,487 |
$ 1,012 |
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Accrued expenses |
4,395 |
5,249 |
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Lease liabilities, current |
102 |
37 |
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Loan payable |
2,408 |
5,239 |
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Convertible notes payable |
4,949 |
4,911 |
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Total current liabilities |
13,341 |
16,448 |
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Warrant liability |
6,160 |
5,548 |
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Lease Liabilities, non-current |
1,016 |
— |
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Other liabilities, non-current |
962 |
840 |
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Total liabilities |
21,479 |
22,836 |
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Commitments and contingencies |
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Stockholders' equity |
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Preferred stock, |
— |
— |
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Common stock, |
254 |
228 |
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Additional paid-in capital |
530,482 |
520,576 |
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Accumulated deficit |
(516,273) |
(505,162) |
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Accumulated other comprehensive loss |
157 |
135 |
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Total stockholders' equity |
14,620 |
15,777 |
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Total liabilities and stockholders' equity |
$ 36,099 |
$ 38,613 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(Unaudited) |
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(in thousands, except share and per share data) |
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Three months ended |
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2024 |
2023 |
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Product revenue |
$ 3,139 |
$ 597 |
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Other revenue |
— |
— |
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Total revenues |
3,139 |
597 |
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Cost of goods sold |
(903) |
(181) |
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Gross profit |
2,236 |
416 |
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Operating expenses: |
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Research and development expenses |
3,700 |
4,576 |
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Selling, general and administrative expenses |
8,814 |
4,165 |
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Total operating expenses |
12,514 |
8,741 |
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Operating loss |
(10,278) |
(8,325) |
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Change in fair value of warrant liability |
(612) |
— |
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Interest expense, net |
(199) |
(688) |
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Other (expense) income |
(22) |
13 |
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Net loss |
(11,111) |
(9,000) |
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Other comprehensive (loss) income: |
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Unrealized gain on investments |
8 |
— |
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Foreign currency translation adjustments |
14 |
19 |
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Total comprehensive loss |
$ (11,089) |
$ (8,981) |
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Common share data: |
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Basic and diluted loss per common share |
$ (0.45) |
$ (0.77) |
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Weighted average number of basic and diluted shares outstanding |
24,887,180 |
11,622,384 |
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