On November 10, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three and nine months ended September 30, 2015 (Press release, Delcath Systems, NOV 10, 2015, View Source;p=RssLanding&cat=news&id=2110968 [SID:1234508184]).
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Financial and other highlights for the third quarter of 2015 and recent weeks included:
84% increase in total revenue compared with the third quarter of 2014
23% decrease in total operating expenses compared with the third quarter of 2014
Establishment of national reimbursement coverage for CHEMOSAT procedures in Germany
Treatment of first patient in the intrahepatic cholangiocarcinoma (ICC) cohort of the Global Phase 2 HCC/ICC trial program
Acceptance for publication of prior Melanoma Phase 3 trial results in the Annals of Surgical Oncology
Presentation of data supporting Delcath’s Hepatic CHEMOSAT Delivery System at the CIRSE, ECCO and EADO annual meetings
Appointment of Jennifer Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath to the Company’s Board of Directors
"Our performance in the third quarter and recent weeks was strong, with significant achievements in all of our commercial and clinical priorities," said Dr. Simpson. "Highlighting the period was the establishment of ZE reimbursement for CHEMOSAT procedures in Germany beginning in 2016, which represents our first national reimbursement mechanism and an important step towards increasing commercialization of CHEMOSAT in Europe. We also continued to drive commercial adoption of CHEMOSAT in other European markets, as evidenced by a nearly 84% increase in third quarter revenue compared with last year. In fact, our year-to-date revenue has already exceeded full-year 2014 revenue. This performance was achieved while maintaining disciplined expense management, which allowed us to beat our operating expense guidance of $4-5 million per quarter."
"During the period we also continued to advance our clinical development program, with the first treatment performed in the ICC cohort of our Global Phase 2 HCC/ICC trial program in October and data supporting CHEMOSAT presented at three major medical conferences. Adding to this growing body of evidence will be data from our prior U.S. Phase 3 clinical trial, which will published in the Annals of Surgical Oncology in the coming weeks. Publication of these results will be an important tool that will enhance our efforts to expand reimbursement in certain European countries, and will also help increase awareness of the value of this therapy in Europe."
"We held a productive meeting with the U.S. Food and Drug Administration regarding our plans for a global pivotal Phase 3 clinical trial in patients with ocular melanoma (OM) that has metastasized to the liver, with overall survival as the primary endpoint. The dialogue was constructive and the FDA is working with Delcath to advance the initiation of this important trial."
"Our team is executing our plan and entirely focused on delivering value for shareholders. We look forward to continuing this momentum through to the end of 2015 and beyond," concluded Dr. Simpson.
Third Quarter Financial Results
Total revenue for the third quarter of 2015 of $0.4 million increased 83.9% from $0.2 million for the third quarter of 2014. Selling, general and administrative expenses during the third quarter were $2.3 million, a decrease of $2.2 million or 48.9% from $4.5 million for the same period in 2014.
Total operating expenses for the third quarter of 2015 decreased by 23.1% to $4.0 million from $5.2 million for the same period in 2014. This decrease reflects a reduction in severance and compensation-related expenses following significant workforce restructurings throughout 2014 and into 2015, as well as a reduction in facility expenses.
The Company recorded a net loss for the third quarter of 2015 of $2.4 million, or $0.12 per share, a decrease of $2.2 million or 47.8%, compared with a net loss of $4.6 million, or $0.48 per share, for the same period in 2014. This decrease is primarily due to a $1.2 million reduction in operating expenses, a $0.1 million improvement in gross profit and a $0.8 million change in the fair value of the warrant liability, a non-cash item.
Nine Month Financial Results
Total revenue for the first nine months of 2015 of $1.3 million increased 62.5% from $0.8 million for the first nine months of 2014. Selling, general and administrative expenses during the first nine months of 2015 were $7.8 million, a decrease of $5.2 million or 40.0% from $13.0 million for the same period in 2014.
Total operating expenses for the first nine months of 2015 decreased by 27.7% to $12.0 million from $16.6 million for the same period in 2014. This decrease reflects a reduction in severance and compensation-related expenses following significant workforce restructurings throughout 2014 and into 2015, as well as a reduction in facility expenses.
The Company recorded a net loss for the first nine months of 2015 of $9.6 million, or $0.67 per share, a decrease of $4.8 million or 33.3% compared with a net loss of $14.4 million, or $1.54 per share, for the same period in 2014. This decrease is primarily due to a $4.7 million reduction in operating expenses, a $0.4 million improvement in gross profit and a $0.2 million change in the fair value of the warrant liability, a non-cash item.
Balance Sheet Highlights
Cash and cash equivalents as of September 30, 2015 were $16.7 million, compared with $20.5 million as of December 31, 2014. During the first nine months of 2015, net cash used in operating activities was $12.2 million.