On March 29, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the fourth quarter and full-year ended December 31, 2021 (Press release, Delcath Systems, MAR 29, 2022, View Source [SID1234611117]).
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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.