Delcath Systems (DCTH) FY2025 10-K Risk Factors: 13 New, 9 Dropped

What the changes say

Delcath updated its risk factors to reflect financial improvements including a net gain of $2.7 million in 2025.
The company added new regulatory risks citing the OBBBA healthcare law enacted on July 4, 2025.
Intellectual property, commercialization of HEPZATO, and pricing compliance under Medicaid remain primary focuses.

What changed since the prior 10-K

New

NewRisks Related to Our Business and Financial Condition
Insufficient capital may require us to curtail or stop our commercialization activities, regulatory submissions or ongoing activities for regulatory approval, research and development and clinical trials, which will significantly limit our potential to generate future revenues
Raising additional capital through equity, debt, or partnerships may dilute existing stockholders, restrict operations, or force us to relinquish rights to our technologies.
NewRisks Related to Our Business and Financial Condition
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, creating liens, redeeming its stock or making investments
Debt financing covenants may restrict our ability to incur debt, make capital expenditures, or declare dividends.
NewRisks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
against more established companies in our industry. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis
We have limited experience commercializing pharmaceutical products like HEPZATO and must maintain effective sales capabilities to compete against established companies.
NewRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
conduct additional studies. Failure to comply with these requirements can result in adverse publicity, FDA warning letters, corrective advertising and potential civil and criminal penalties
Failure to comply with reporting and payment obligations under the Medicaid Drug Rebate Program can result in penalties, fines, and adverse publicity.
NewRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
requirements, we may become subject to penalties or other enforcement mechanisms, which could have a material adverse effect on our business
Complex pricing and rebate calculations under government programs could lead to restatements, increased compliance costs, or civil monetary penalties.
NewRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
We cannot assure that our submissions will not be found to be incomplete or incorrect
The OBBBA enacted on July 4, 2025 narrowed ACA marketplace enrollment and premium tax credits, which may reduce the number of insured Americans and impact product sales.
NewRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
perform their obligations to us, we may not be able to obtain the necessary regulatory approvals for our products or product candidates, as applicable
We rely on third parties and academic institutions to manage clinical trials, reducing our control over timing and execution.
NewRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
products or product candidates that receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future
While CMS established a permanent J-Code for HEPZATO on April 1, 2024, future reimbursement rates and heightened government scrutiny on drug pricing pose ongoing risks.
NewRisks Related to our Intellectual Property
Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
Extensive development and regulatory review times may cause related patents for CHEMOSAT and HEPZATO to expire or leave only a short protection period following commercialization.
NewRisks Related to our Intellectual Property
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
We may face costly claims from former employees or third parties challenging the inventorship or ownership of our patents and intellectual property.
NewRisks Related to our Intellectual Property
If we breach our license agreements, it could have a material adverse effect on our commercialization efforts for our product candidates
Breaching third-party license agreements or failing to meet diligence and milestone obligations could cause us to lose critical patent rights.
NewRisks Related to our Intellectual Property
product candidates. Such disclosures could preclude us from obtaining patents covering disclosed inventions and product candidates and could adversely affect our business, competitive position, and operating results
Trade secret protection does not prevent independent discovery and duplication of our technology by competitors in countries where we lack patent protection.
NewRisks Related to Our Common Stock
There can be no assurance that any share repurchase will enhance long-term stockholder value

Dropped

DroppedRisks Related to Our Business and Financial Condition
future product development, if any, including clinical trials for new product candidates or for HEPZATO or CHEMOSAT in additional indications for which we do not currently have regulatory approval
DroppedRisks Related to Our Business and Financial Condition
Raising additional capital, or the exercise or conversion of securities exercisable or convertible into shares of common stock, may cause dilution to our existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights
Prior and potential future losses affecting working capital and product revenue dependence.
DroppedRisks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel
Dilution from raising capital and exercise of warrants or options.
DroppedRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions
DroppedRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor cost-containment initiatives, may have a material adverse effect on us
DroppedRisks Related to our Intellectual Property
Our success depends in part on our ability to commercialize CHEMOSAT and HEPZATO prior to the expiration of our patent protection
DroppedRisks Related to our Intellectual Property
hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could cause the price of our common stock to decline
DroppedRisks Related to Our Common Stock
fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences
DroppedRisks Related to Our Common Stock
contracted with a third party vendor to increase the cybersecurity trainings for all employees there can be no guarantee that future phishing attempts won't be successful

Reworded

92% rewrittenRisks Related to Our Business and Financial Condition
We have incurred significant losses since inception and continuing losses may exhaust our capital resources
Updated cash and investment figures as of December 31, 2025, and reported a net gain of approximately $2.7 million for the 2025 fiscal year.
88% rewrittenRisks Related to Our Common Stock
The loss of key personnel could adversely affect our business
No substantive changes made to key personnel risk text.
68% rewrittenRisks Related to our Intellectual Property
We may in the future become involved in lawsuits to protect or enforce our intellectual property, or to defend our products against assertion of intellectual property rights by a third party, which could be expensive, time consuming and unsuccessful
No substantive changes made to intellectual property litigation risk text.
62% rewrittenRisks Related to our Intellectual Property
We may rely primarily on trade secret protection for important proprietary technologies
Added technical, administrative, and physical safeguards as measures used to protect trade secrets and restrict proprietary information.
57% rewrittenRisks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
We may be unsuccessful in commercializing CHEMOSAT and HEPZATO because of inadequate infrastructure or an ineffective commercialization strategy
No substantive changes made to infrastructure and commercialization strategy risk text.
48% rewrittenRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
The FDA has granted us six orphan drug designations and we may seek additional orphan drug designations in the future
No substantive changes made to orphan drug designation risk text.
45% rewrittenRisks Related to Tax Matters
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
Updated tax law references to note that the Tax Cuts and Jobs Act required capitalization and amortization of R&D expenses starting January 1, 2022.
42% rewrittenRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
The success of our products may be harmed if the government, private health insurers or other third-party payors do not provide sufficient coverage or reimbursement
No substantive changes made to third-party coverage and reimbursement risk text.
40% rewrittenRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
CHEMOSAT and HEPZATO may not achieve sufficient acceptance by the medical community to sustain our business
33% rewrittenRisks Related to our Intellectual Property
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies
31% rewrittenRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties
23% rewrittenRisks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
Our ability to market HEPZATO is limited to those uses that are approved

All 59 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Financial Condition

01We have incurred significant losses since inception and continuing losses may exhaust our capital resources92% rewritten
02Insufficient capital may require us to curtail or stop our commercialization activities, regulatory submissions or ongoing activities for regulatory approval, research and development and clinical trials, which will significantly limit our potential to generate future revenuesNew
03covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, creating liens, redeeming its stock or making investmentsNew
04We have in the past, and may in the future, become subject to litigation or claims arising in or outside the ordinary course of business that could negatively affect our business operations and financial condition
05We may be the subject of product liability claims or product recalls, and we may be unable to maintain insurance adequate to cover potential liabilities

Risks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO

06We have limited experience as a commercial company and generating revenue from product sales. If the continued commercialization of HEPZATO is unsuccessful or any future approved products are unsuccessful, we may never be profitable
07We currently have an agreement with one supplier of melphalan and, with the goal of minimizing the risk of a supply interruption, are in discussions with several melphalan abbreviated NDA holders who have indicated interest in supplying melphalan to us
08If we cannot successfully manufacture CHEMOSAT and HEPZATO, our ability to develop and commercialize the system would be impaired
09We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT and HEPZATO
10We may be unsuccessful in commercializing CHEMOSAT and HEPZATO because of inadequate infrastructure or an ineffective commercialization strategy57% rewritten
11against more established companies in our industry. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basisNew
12We may need to enter into collaborative arrangements with third parties to help market and sell CHEMOSAT and HEPZATO, but it may not be successful
13If we fail to overcome the challenges inherent in international operations, our business and results of operations may be materially adversely affected
14Rapid technological developments in treatment methods for liver cancer and competition with other forms of liver cancer treatments could affect our ability to achieve meaningful revenues or profit
15We may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for the commercial success of CHEMOSAT or HEPZATO, in which case we may not generate significant revenue for the foreseeable future

Risks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters

16The development and approval process in the United States and abroad could take many years, require substantial resources and may never lead to the approval of our product candidates by the FDA for use in the United States or by foreign regulators in their respective jurisdictions
17Our ability to market HEPZATO is limited to those uses that are approved23% rewritten
18conduct additional studies. Failure to comply with these requirements can result in adverse publicity, FDA warning letters, corrective advertising and potential civil and criminal penaltiesNew
19requirements, we may become subject to penalties or other enforcement mechanisms, which could have a material adverse effect on our businessNew
20We cannot assure that our submissions will not be found to be incomplete or incorrectNew
21HEPZATO is now approved for the treatment of adult patients with unresectable hepatic-dominant mUM. The approval was based primarily on the results of the FOCUS Trial, a Phase 3, single arm, multicenter, open label study
22We are subject to significant ongoing regulatory obligations and oversight in the European Union and the United States and will be in any other country where we receive marketing authorization or approval
23The FDA has granted us six orphan drug designations and we may seek additional orphan drug designations in the future48% rewritten
24perform their obligations to us, we may not be able to obtain the necessary regulatory approvals for our products or product candidates, as applicableNew
25Purchasers of CHEMOSAT in Europe may not receive third-party reimbursement or such reimbursement may be inadequate. Without adequate reimbursement, commercialization of CHEMOSAT in Europe may not be successful
26The success of our products may be harmed if the government, private health insurers or other third-party payors do not provide sufficient coverage or reimbursement42% rewritten
27products or product candidates that receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the futureNew
28CHEMOSAT and HEPZATO may not achieve sufficient acceptance by the medical community to sustain our business40% rewritten
29We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties31% rewritten
30Consolidation in the healthcare industry could lead to demands for price concessions

Risks Related to our Intellectual Property

31Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively
32We have not and may not be able to adequately protect our intellectual property rights throughout the world
33Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
34Our success depends in part on our ability to obtain patents, which can be an expensive, time consuming, and uncertain process, and the value of the patents is dependent in part on the breadth of coverage and the relationship between the coverage and the commercial product
35Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of timeNew
36We may in the future become involved in lawsuits to protect or enforce our intellectual property, or to defend our products against assertion of intellectual property rights by a third party, which could be expensive, time consuming and unsuccessful68% rewritten
37We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual propertyNew
38Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies33% rewritten
39If we breach our license agreements, it could have a material adverse effect on our commercialization efforts for our product candidatesNew
40Our trademarks may be infringed or successfully challenged, resulting in harm to our business
41We may rely primarily on trade secret protection for important proprietary technologies62% rewritten
42product candidates. Such disclosures could preclude us from obtaining patents covering disclosed inventions and product candidates and could adversely affect our business, competitive position, and operating resultsNew
43We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of confidentiality, non-competition or non-solicitation agreements with our competitors

Risks Related to Tax Matters

44Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations45% rewritten
45Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited
46Tax authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability

Risks Related to Our Common Stock

47The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors
48Because of volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation
49As of December 31, 2025, 34,691,671 shares of common stock are issued and outstanding, and we have reserved 13,943,391 shares of our common stock for future issuance pursuant to our stock option and equity incentive plans, outstanding warrants and preferred stock
50There can be no assurance that any share repurchase will enhance long-term stockholder valueNew
51Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control or make it more difficult for our stockholders to replace management
52We have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future
53If we engage in acquisitions, reorganizations or business combinations, we will incur a variety of risks that could adversely affect our business operations or our stockholders
54If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could decline
55The loss of key personnel could adversely affect our business88% rewritten
56We will continue to incur significant costs as a result of operating as a public company, and our management will continue to devote substantial time to compliance initiatives
57We are a “smaller reporting company” and have elected to comply with reduced public company reporting requirements, which could make our common stock less attractive to investors
58Further downgrades of the United States credit rating, automatic spending cuts, or a government shutdown could negatively impact our liquidity, financial condition and earnings
59Environmental, social and governance matters and any related reporting obligations may impact our business

Other Delcath Systems 10-Ks

FY2024 10-K risk factors
55 risks
Delcath depends heavily on commercializing HEPZATO and CHEMOSAT for treating liver cancer.
Filed Mar 06, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.