Delcath Systems, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 9 November 2026: press release. Guidance figures: 2 raised, 1 narrowed. The quarter’s numbers.

Key takeaways

Third-quarter revenue reached $35.1 million: Total revenue was $35.1 million, compared with $20.6 million in the third quarter of 2025. Revenue was $29.1 million in the second quarter. Source
Gross margin rose to 89%: Gross margin was 89% in the quarter, against 87% a year earlier. Full-year gross margin guidance now runs 87% to 89%, from 86% to 89%. Source
Adjusted EBITDA rose to $11.5 million: Non-GAAP adjusted EBITDA was $11.5 million, compared with $5.3 million in the third quarter of 2025 and $7.6 million in the second quarter of 2026. Source
HEPZATO volume up about 72%: HEPZATO volume grew approximately 72% in the third quarter of 2026 compared with the third quarter of 2025, after about 30% growth in the second quarter. Source
DELUMA Phase 2 trial advancing: The global Phase 2 DELUMA trial compares HEPZATO with standard-of-care therapy against standard of care alone in liver-dominant HER2-negative metastatic breast cancer. Source
Cash and investments reached $104.3 million: Cash and investments were $104.3 million at September 30, 2026, against $95.9 million at June 30, 2026, with no debt. Source
Operating cash flow was $8.2 million: Cash provided by operations was $8.2 million in the quarter, against $4.8 million in the third quarter of 2025 and $5.7 million in the second quarter of 2026. Source

“We are pleased with the continued momentum in our business, with meaningful progress across both commercial operations and clinical development,”
Gerard Michel, Chief Executive Officer of Delcath Systems

Guidance

Area	Period	Figure	Against last quarter
Total HEPZATO KIT and CHEMOSAT revenue Source	Fiscal year 2026	$115 million to $117 million	Raised from $104 million to $108 million
HEPZATO KIT volume growth Source	Fiscal year 2026 compared with 2025	at least 41%	Raised from at least 28%
Gross margin Source	Fiscal year 2026	87% to 89%	Narrowed, low end up from 86% to 89%

What changed from last quarter

Guidance raised: 2026 revenue guidance raised to $115 million to $117 million from $104 million to $108 million. Source
Guidance raised: HEPZATO KIT volume growth guidance raised to at least 41% over 2025, from at least 28%. Source
Guidance raised: Full-year gross margin guidance lower end raised to 87% from 86%; upper end unchanged at 89%. Source
Guidance kept: Guidance for positive full-year adjusted EBITDA is unchanged from the prior release. Source
New: Management stated a planned IND submission for cholangiocarcinoma in early 2027, which the prior release did not mention. Source
New: Management stated completion of preclinical development of an oxaliplatin-based PHP product by mid-2027, pending FDA agreement. Source

Results and growth drivers

Third-quarter revenue reached $35.1 million: Total revenue was $35.1 million, compared with $20.6 million in the third quarter of 2025. Revenue was $29.1 million in the second quarter. Source
Net income rose to $7.0 million: Net income was $7.0 million, compared with $0.8 million a year earlier, and $2.7 million in the second quarter. Source
Diluted EPS rose to $0.17: Diluted income per common share was $0.17, against $0.02 in the third quarter of 2025. Basic income per share was $0.19. Source

Segments and regions

U.S. HEPZATO sales led the quarter: HEPZATO sales in the U.S. were $32.7 million of the $35.1 million total, with the remainder from CHEMOSAT sales in Europe. Source
CHEMOSAT Europe revenue grew: CHEMOSAT revenue was $2.4 million in Europe, compared with $1.3 million in the third quarter of 2025. Source
Both product lines up from second quarter: Compared with the prior quarter, U.S. HEPZATO sales rose from $27.1 million and European CHEMOSAT sales from $2.0 million.

“Growing physician experience with HEPZATO, strong engagement across our treatment center network, and increasing interest in its use alongside systemic therapies reinforce our confidence in the long-term opportunity.”
Gerard Michel, Chief Executive Officer of Delcath Systems

Costs, margins and profitability

Gross margin rose to 89%: Gross margin was 89% in the quarter, against 87% a year earlier. Full-year gross margin guidance now runs 87% to 89%, from 86% to 89%. Source
R&D spending rose on trials: Research and development expenses were $11.0 million, compared with $8.0 million a year earlier and $10.4 million in the second quarter. Source
SG&A rose with commercial expansion: Selling, general and administrative expenses were $13.1 million, compared with $10.3 million a year earlier and $13.4 million in the second quarter. Source
Adjusted EBITDA rose to $11.5 million: Non-GAAP adjusted EBITDA was $11.5 million, compared with $5.3 million in the third quarter of 2025 and $7.6 million in the second quarter of 2026. Source

Demand and treatment centers

HEPZATO volume up about 72%: HEPZATO volume grew approximately 72% in the third quarter of 2026 compared with the third quarter of 2025, after about 30% growth in the second quarter. Source
Treatment center network expanded: The company reported 33 active treatment centers, up from 31 in the second quarter. Source
Physician experience cited as driver: Management attributed the momentum to growing physician experience, engagement across the treatment center network, and interest in use alongside systemic therapies. Source

“We are also expanding our pipeline, with a planned IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027.”
Gerard Michel, Chief Executive Officer of Delcath Systems

Clinical development and pipeline

DELUMA Phase 2 trial advancing: The global Phase 2 DELUMA trial compares HEPZATO with standard-of-care therapy against standard of care alone in liver-dominant HER2-negative metastatic breast cancer. Source
Trial enrollment target of 90: The randomized trial is designed to enroll about 90 patients at more than 20 sites across the U.S. and Europe. Source
Pipeline expansion named: Management said the company is expanding its pipeline with a cholangiocarcinoma IND and an oxaliplatin-based PHP product, the latter pending FDA agreement. Source

Capital, cash and balance sheet

Cash and investments reached $104.3 million: Cash and investments were $104.3 million at September 30, 2026, against $95.9 million at June 30, 2026, with no debt. Source
Operating cash flow was $8.2 million: Cash provided by operations was $8.2 million in the quarter, against $4.8 million in the third quarter of 2025 and $5.7 million in the second quarter of 2026. Source
Common share count increased slightly: Common shares outstanding were 34,771,239 at September 30, 2026, against 34,691,671 at December 31, 2025. Source

Coming up, as management said on 9 November 2026

Cholangiocarcinoma IND submission: Management expects to submit an IND for cholangiocarcinoma in early 2027. Source
Oxaliplatin PHP preclinical completion: Preclinical development of an oxaliplatin-based PHP product is expected to be complete by mid-2027, pending FDA agreement. Source

Figures management reported

Figure	Reported
Active treatment centers Source	33
HEPZATO volume growth, third quarter 2026 vs third quarter 2025 Source	approximately 72%

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Delcath Systems Reports Third Quarter 2026

Results and Business Highlights

Increases 2026 Revenue Guidance to a Range of $115 million to $117 million

Conference Call Today at 8:30 a.m. Eastern Time

QUEENSBURY, NY - November 9, 2026, Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the third quarter ended September 30, 2026.

Third Quarter 2026 Financial Results

Total revenue of $35.1 million, compared with $20.6 million in the third quarter of 2025
HEPZATO KIT™ revenue of $32.7 million, compared to $19.3 million in the third quarter of 2025
CHEMOSAT® revenue of $2.4 million, compared to $1.3 million in the third quarter of 2025
Gross margins of 89%, compared to 87% in the third quarter of 2025
Net income of $7.0 million, compared to $0.8 million in the third quarter of 2025
Non-GAAP adjusted EBITDA of $11.5 million, compared to $5.3 million in the third quarter of 2025
Cash provided by operations of $8.2 million in the quarter; compared to $4.8 million in the third quarter of 2025
Cash and investments of $104.3 million as of September 30, 2026; and no debt

Business Highlights

Currently 33 active treatment centers
Approximately 72% growth in HEPZATO volume in the third quarter 2026 compared to the third quarter 2025
Advanced the global Phase 2 DELUMA trial (NCT06875128), evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer; first patient dosed July 9, 2026, at the European Institute of Oncology in Milan, Italy. The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites.

“We are pleased with the continued momentum in our business, with meaningful progress across both commercial operations and clinical development,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “Growing physician experience with HEPZATO, strong engagement across our treatment center network, and increasing interest in its use alongside systemic therapies reinforce our confidence in the long-term opportunity. We are also expanding our pipeline, with a planned IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027.”

2026 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2026:

Total HEPZATO KIT and CHEMOSAT revenue to range from $115 million to $117 million, reflecting an increase in HEPZATO KIT volume of at least 41% over 2025
Full year gross margins in the range of 87% to 89%
Positive adjusted EBITDA

Third Quarter 2026 Results

Total revenue for the quarter ending September 30, 2026 was $35.1 million compared to $20.6 million for the same period in the prior year. Revenue in the quarter includes sales of $32.7 million of HEPZATO in the U.S. and $2.4 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending September 30, 2026, were $11.0 million compared to $8.0 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity.

Selling, general and administrative expenses for the quarter ended September 30, 2026, were $13.1 million compared to $10.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities.

Net income was $7.0 million for the quarter ended September 30, 2026, compared to $0.8 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended September 30, 2026 was $11.5 million compared to adjusted EBITDA of $5.3 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of September 30, 2026, the Company had $104.3 million in cash and investments, and no debt.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, November 9, 2026

Time: 8:30 AM Eastern Time

Participant Numbers:

Toll Free: 1-800-717-1738

International: 1-646-307-1865

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1767384&tp_key=cbc23b55c8

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website https://investors.delcath.com/news-events/events-and-presentations.

GAAP v. Non-GAAP Measures

Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.

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 (HDS) 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 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.

Safe Harbor / Forward-Looking Statements

Forward-looking statements notice

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, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, 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; contributions to adjusted EBITDA; 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.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

	September 30, 2026	December 31, 2025
Assets
Current assets
Cash and cash equivalents	$55,538	$43,454
Short-term investments	48,777	47,582
Accounts receivable	20,214	11,744
Inventories	10,501	10,252
Prepaid expenses and other current assets	6,525	6,498
Total current assets	141,555	119,530
Property, plant and equipment, net	5,127	3,166
Right-of-use assets	2,408	936
Total assets	$149,090	$123,632
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$3,475	$2,658
Accrued expenses	9,351	8,191
Lease liabilities, current	196	101
Total current liabilities	13,022	10,950
Lease liabilities, non-current	2,212	835
Other liabilities, non-current	319	628
Total liabilities	$15,553	$12,413
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 14,192 and 14,192 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively	-	-
Common stock, $0.01 par value; 80,000,000 shares authorized; 34,771,239 shares and 34,691,671 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively	348	347
Additional paid-in capital	653,118	639,145
Accumulated deficit	(520,298)	(528,848)
Accumulated other comprehensive income	369	575
Total stockholders’ equity	133,537	111,219
Total liabilities and stockholders’ equity	$149,090	$123,632

Condensed Consolidated Statements of Operations and Comprehensive Income

(Unaudited)

(in thousands, except share and per share data)

	Three months ended September 30,				Nine months ended September 30,
	2026		2025		2026		2025
Product revenue	$35,102		$20,563		$89,229		$64,503
Cost of goods sold	(3,918)		(2,624)		(10,639)		(8,787)
Gross profit	31,184		17,939			78,590		55,716
Operating expenses:
Research and development expenses	11,011		7,986			31,215		19,875
Selling, general and administrative expenses	13,057		10,341			39,501		32,997
Total operating expenses	24,068		18,327			70,716		52,872
Operating income	7,116		(388)		7,874		2,844
Interest income	852		796		2,420		2,063
Other expense	(1)		(33)		(76)		$(63)
Income before income taxes	7,967		375		10,218		4,844
Income tax expense (benefit)	1,015		(455)		1,668		248
Net income	6,952		830		8,550		4,596
Other comprehensive income (loss):
Unrealized gain on investments adjustments	115		296		(135)		592
Foreign currency translation adjustments	(4)		(13)		(71)		201
Total comprehensive income	$7,063		$1,113		$8,344		$5,389
Common share data:
Basic income per common share	$0.19		$0.02		$0.24		$0.13
Weighted average number of basic shares outstanding		36,074,348		36,383,277		35,996,019		35,610,619
Diluted income per common share	$0.17		$0.02		$0.21		$0.12
Weighted average number of dilutive shares outstanding		41,019,553		40,056,814		40,059,103		39,949,941

Reconciliation of Reported Net Income (GAAP) to Adjusted EBITDA (NON-GAAP Measure)

(Unaudited)

(in thousands)

	Three months ended September 30,		Nine months ended September 30,
	2026	2025	2026	2025
Net income	$6,952	$830	$8,550	$4,596
Stock-based compensation expense	4,233	5,648	14,297	19,720
Depreciation	153	64	368	158
Interest income	(852)	(796)	(2,420)	(2,063)
Income tax expense	1,015	(455)	1,668	248
Adjusted EBITDA (Non-GAAP)	$11,501	$5,291	$22,463	$22,659

Contacts
ICR Healthcare investorrelations@delcath.com