Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today reported business highlights and financial
results for the fourth quarter and full-year ended December 31,
2021.
Recent Business Highlights
During and since the fourth quarter, Delcath:
- Reported updated
positive phase 3 FOCUS trial results for HEPZATO™ Kit (melphalan
hydrochloride for injection/hepatic delivery system) for the
treatment of patients with unresectable liver-dominant metastatic
ocular melanoma, including initial survival data analysis
- Confirmed guidance
for the mid-year Class 2 resubmission of the NDA to FDA
- Resumed direct
responsibility for sales, marketing, and distribution activities
for the CHEMOSAT® Hepatic Delivery System in all
of Europe
- Achieved medical
device regulation certification for CHEMOSAT® in Europe
- Appointed David
Hoffman as General Counsel and Chief Compliance Officer and Anthony
Dias as Vice President of Finance
In addition, during and since the fourth quarter, independent
investigators published:
- Repeated
percutaneous hepatic perfusion with melphalan can maintain
long-term response in patients with liver cancers in the journal
Cardiovascular and Interventional Radiology1
- Chemosaturation
with percutaneous hepatic perfusion of melphalan for metastatic
uveal melanoma in the journal Melanoma Research2
- Percutaneous
Hepatic Perfusion (PHP) with Melphalan in Liver-Dominant Metastatic
Uveal Melanoma: The German Experience in the journal Cancers3
- Initiation of
Chemosaturation with Percutaneous Hepatic Perfusion Program in
Interventional Radiology Department in the journal Cureus4
“Since the end of the third quarter, we have updated our
previously reported positive phase 3 data with survival data,
resumed direct sales of CHEMOSAT in Europe, and strengthened our
leadership team,” said Gerard Michel, CEO of Delcath. “Each of
these achievements support our strategic priorities – filing of the
HEPZATO NDA in mid-2022, preparing for the subsequent US launch
when approved, and expanding the development of HEPZATO and
CHEMOSAT into additional areas of high unmet need. We look forward
to a pre-NDA meeting with FDA in the coming weeks.”
Fourth Quarter 2021 Results
Income Statement Highlights.
Product revenue for the three months ended December 31, 2021,
was approximately $0.2 million, compared to $0.4 million for the
prior year quarter from sales of CHEMOSAT in Europe. Other income
for the quarter was $1.9 million compared to $0.1 million in the
prior year quarter with the increase primarily due to the
acceleration of deferred revenue caused by the termination of the
medac license agreement. Research and development expenses for the
quarter were $3.6 million compared to $2.7 million in the prior
year quarter. Selling, general and administrative expenses for the
quarter were approximately $3.0 million compared to $4.5 million in
the prior year quarter. Total operating expenses for the quarter
were $6.6 million compared with $7.3 million in the prior year
quarter. Expenses for the quarter included approximately $1.6
million of stock option expense compared to $3.5 million in the
prior year quarter.
The Company recorded a net loss for the three months ended
December 31, 2021, of $5.3 million, compared to a net loss of $7.0
million for the same period in 2020.
Full-Year 2021 Results
Product revenue for the year ended December 31, 2021, was
approximately $1.3 million, compared to $1.2 million for the prior
year from sales of CHEMOSAT in Europe. Other income for the year
was $2.2 million compared to $0.5 million in the prior year with
the increase primarily due to the acceleration of deferred revenue
caused by the termination of the medac license agreement. Research
and development expenses for the year were $13.8 million compared
to $11.2 million in the prior year. Selling, general and
administrative expenses for the year were approximately $13.6
million compared to $11.2 million in the prior year. Total
operating expenses for the year were $27.4 million compared with
$22.3 million in the prior year. Expenses for the year included
approximately $7.8 million of stock option expense compared to $3.9
million in the prior year.
The Company recorded a net loss for the year ended December 31,
2021, of $25.6 million, compared to a net loss of $24.2 million for
the year ended December 31, 2020.
Balance Sheet Highlights.
On December 31, 2021, the company had cash, cash equivalents and
restricted cash totaling $27.0 million, as compared to cash, cash
equivalents and restricted cash totaling $28.7 million on December
31, 2020. During the three months ended December 31, 2021 and
December 31, 2020, we used $6.4 million and $5.0 million,
respectively, of cash in our operating activities.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: March 25, 2021Time: 8:30 AM Eastern TimeToll Free:
888-506-0062; Entry Code: 938572International: 973-528-0011; Entry
Code: 938572Webcast:
https://www.webcaster4.com/Webcast/Page/2475/44898
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company’s proprietary percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the PHP system is being developed
under the tradename HEPZATO KIT (melphalan hydrochloride for
injection/hepatic delivery system), or HEPZATO, for the treatment
of metastatic ocular melanoma (mOM), also known as metastatic uveal
melanoma (mUM) and is considered a combination drug and device
product regulated by the United States Food and Drug Administration
(FDA).
In Europe, the PHP system is now regulated as a Class lll
medical device and is approved for sale under the trade name
CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where
it has been used at major medical centers to treat a wide range of
cancers of the liver.
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 news release contains forward-looking
statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: the timing and results
of the Company’s clinical trials, including without limitation the
mOM and ICC clinical trial programs, as well as the receipt of
additional data and the performance of additional analyses with
respect to the mOM clinical trial, our determination whether to
continue the ICC clinical trial program or to focus on other
alternative indications, and timely monitoring and treatment of
patients in the global Phase 3 mOM clinical trial and the impact of
the COVID-19 pandemic on the completion of our clinical trials; the
impact of the presentations at major medical conferences and future
clinical results consistent with the data presented; approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure; the impact, if any, of ZE reimbursement on potential
CHEMOSAT product use and sales in Germany; clinical adoption, use
and resulting sales, if any, for the CHEMOSAT system to deliver and
filter melphalan in Europe including the key markets of Germany and
the UK; the Company’s ability to successfully commercialize the
HEPZATO KIT/CHEMOSAT system and the potential of the HEPZATO
KIT/CHEMOSAT system as a treatment for patients with primary and
metastatic disease in the liver; our ability to obtain
reimbursement for the CHEMOSAT system in various markets; approval
of the current or future HEPZATO KIT/CHEMOSAT system for delivery
and filtration of melphalan or other chemotherapeutic agents for
various indications in the U.S. and/or in foreign markets; actions
by the FDA or foreign regulatory agencies; the Company’s ability to
successfully enter into strategic partnership and distribution
arrangements in foreign markets and the timing and revenue, if any,
of the same; uncertainties relating to the timing and results of
research and development projects; and uncertainties regarding the
Company’s ability to obtain financial and other resources for any
research, development, clinical trials and commercialization
activities. These factors, and others, are discussed from time to
time in our filings with the Securities and Exchange Commission.
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.
- Veelken R, Maiwald
B, Strocka S, Petersen TO, Moche M, Ebel S, Denecke T, Rehak M,
Struck MF, Forstmeyer D, Rademacher S, Seehofer D, Berg T, van
Bömmel F. Repeated percutaneous hepatic perfusion with melphalan
can maintain long-term response in patients with liver cancers.
Cardiovasc Intervent Radiol. 2021 Oct 29. doi:
10.1007/s00270-021-02983-2. Epub ahead of print.
- Modi S, Gibson T,
Vigneswaran G, Patel S, Wheater M, Karydis I, Gupta S, Takhar A,
Pearce N, Ottensmeier C, Stedman B. Chemosaturation with
percutaneous hepatic perfusion of melphalan for metastatic uveal
melanoma. Melanoma research. 2022 Feb 2;32(2):103-11.
- Dewald CLA, Warnke
MM, Brüning R, Schneider MA, Wohlmuth P, Hinrichs JB, Saborowski A,
Vogel A, Wacker FK. Percutaneous Hepatic Perfusion (PHP) with
Melphalan in Liver-Dominant Metastatic Uveal Melanoma: The German
Experience. Cancers 2022, 14, 118.
https://doi.org/10.3390/cancers14010118.
- Öcal O, Eldem G,
Karagoz AH, Kılıçkap S, Yalcin S, Balkanci F, Peynircioglu B.
Initiation of Chemosaturation With Percutaneous Hepatic Perfusion
Program in Interventional Radiology Department. Cureus 13(9):
e17880. doi:10.7759/cureus.17880.
Contact:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
|
DELCATH SYSTEMS, INC. |
Consolidated Balance Sheets |
(Unaudited, in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2021 |
|
|
|
|
2020 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,802 |
|
|
|
$ |
28,575 |
|
Restricted cash |
|
|
4,151 |
|
|
|
|
181 |
|
Accounts receivable, net |
|
|
44 |
|
|
|
|
57 |
|
Inventories |
|
|
1,412 |
|
|
|
|
855 |
|
Prepaid expenses and other current assets |
|
|
2,743 |
|
|
|
|
2,670 |
|
Total current assets |
|
|
31,152 |
|
|
|
|
32,338 |
|
Property, plant and equipment, net |
|
|
1,348 |
|
|
|
|
1,351 |
|
Right-of-use assets |
|
|
624 |
|
|
|
|
946 |
|
Total assets |
|
$ |
33,124 |
|
|
|
$ |
34,635 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
|
$ |
638 |
|
|
|
$ |
1,774 |
|
Accrued expenses |
|
|
4,109 |
|
|
|
|
5,241 |
|
Deferred revenue, current |
|
|
170 |
|
|
|
|
525 |
|
Lease liabilities, current |
|
|
416 |
|
|
|
|
495 |
|
Loan payable, current |
|
|
621 |
|
|
|
|
— |
|
Convertible notes payable, current |
|
|
— |
|
|
|
|
2,000 |
|
Total current liabilities |
|
|
5,954 |
|
|
|
|
10,035 |
|
Deferred revenue, non-current |
|
|
— |
|
|
|
|
2,072 |
|
Lease liabilities, non-current |
|
|
207 |
|
|
|
|
450 |
|
Loan payable, non-current |
|
|
10,372 |
|
|
|
|
— |
|
Convertible notes payable, non-current |
|
|
4,639 |
|
|
|
|
— |
|
Total liabilities |
|
|
21,172 |
|
|
|
|
12,557 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Preferred stock, $.01 par value; 10,000,000 shares authorized;
11,357 and 20,631 shares issued and outstanding at December 31,
2021 and 2020, respectively |
|
|
— |
|
|
|
|
— |
|
Common stock, $.01 par value; 40,000,000 shares authorized;
7,906,728 and 5,996,101 shares issued and outstanding at December
31, 2021 and 2020, respectively |
|
|
79 |
|
|
|
|
60 |
|
Additional paid-in capital |
|
|
432,831 |
|
|
|
|
417,449 |
|
Accumulated deficit |
|
|
(420,976 |
) |
|
|
|
(395,327 |
) |
Accumulated other comprehensive loss |
|
|
18 |
|
|
|
|
(104 |
) |
Total stockholders' equity |
|
|
11,952 |
|
|
|
|
22,078 |
|
Total liabilities and stockholders' equity |
|
$ |
33,124 |
|
|
|
$ |
34,635 |
|
|
|
|
|
|
|
DELCATH SYSTEMS, INC. |
Consolidated Statements of Operations and Comprehensive
Income (Loss) |
(Unaudited, in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
For the Year |
|
|
For the Three Months Ended |
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
2021 |
|
|
|
2020 |
|
Product revenue |
|
$ |
1,300 |
|
|
$ |
1,156 |
|
|
|
$ |
246 |
|
|
$ |
379 |
|
Other revenue |
|
|
2,255 |
|
|
|
490 |
|
|
|
|
1,862 |
|
|
|
129 |
|
Cost of goods sold |
|
|
(671 |
) |
|
|
(640 |
) |
|
|
|
(130 |
) |
|
|
(206 |
) |
Gross profit |
|
|
2,884 |
|
|
|
1,006 |
|
|
|
|
1,977 |
|
|
|
301 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
13,778 |
|
|
|
11,201 |
|
|
|
|
3,619 |
|
|
|
2,744 |
|
Selling, general and administrative expenses |
|
|
13,637 |
|
|
|
11,108 |
|
|
|
|
3,017 |
|
|
|
4,537 |
|
Total operating expenses |
|
|
27,415 |
|
|
|
22,309 |
|
|
|
|
6,636 |
|
|
|
7,281 |
|
Operating loss |
|
|
(24,531 |
) |
|
|
(21,303 |
) |
|
|
|
(4,658 |
) |
|
|
(6,980 |
) |
|
|
|
|
|
|
|
|
|
|
Change in fair value of the warrant liability, net |
|
|
— |
|
|
|
(2,832 |
) |
|
|
|
— |
|
|
|
— |
|
Interest expense, net |
|
|
(1,186 |
) |
|
|
(175 |
) |
|
|
|
(684 |
) |
|
|
(43 |
) |
Other income, net |
|
|
68 |
|
|
|
154 |
|
|
|
|
(6 |
) |
|
|
(6 |
) |
Net loss |
|
|
(25,649 |
) |
|
|
(24,156 |
) |
|
|
|
(5,348 |
) |
|
|
(7,029 |
) |
|
|
|
|
|
|
|
|
|
|
- |
|
Deemed dividend for triggering of warrant down round feature |
|
|
— |
|
|
|
(55 |
) |
|
|
|
— |
|
|
|
— |
|
Net loss attributable to common stockholders |
|
$ |
(25,649 |
) |
|
$ |
(24,211 |
) |
|
|
$ |
(5,348 |
) |
|
$ |
(7,029 |
) |
|
|
|
|
|
|
|
|
|
|
- |
|
Net loss |
|
$ |
(25,649 |
) |
|
$ |
(24,156 |
) |
|
|
$ |
(5,348 |
) |
|
$ |
(7,029 |
) |
|
|
|
|
|
|
|
|
|
|
- |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
- |
|
Foreign currency translation adjustments |
|
|
122 |
|
|
|
(132 |
) |
|
|
|
37 |
|
|
|
(93 |
) |
Total other comprehensive loss |
|
$ |
(25,527 |
) |
|
$ |
(24,288 |
) |
|
|
$ |
(5,311 |
) |
|
$ |
(7,122 |
) |
|
|
|
|
|
|
|
|
|
|
- |
|
Common share data: |
|
|
|
|
|
|
|
|
|
- |
|
Basic and diluted loss per common share |
|
$ |
(3.59 |
) |
|
$ |
(8.35 |
) |
|
|
$ |
(0.69 |
) |
|
$ |
(1.66 |
) |
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
Weighted average number of basic and diluted shares
outstanding |
|
|
7,145,754 |
|
|
|
2,897,827 |
|
|
|
|
7,797,357 |
|
|
|
4,223,687 |
|
|
|
|
|
|
|
|
|
|
|
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