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PRE-MKT · 04:35 ET
Market ClerkRecap
Mon Oct 26 · pre-market1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 31The week ahead

DCTH

DELCATH SYSTEMS, INC.
NASDAQ · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
14.42
−0.33 −2.24%
USD · close Oct 23
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Work order
63
WATCH · shorts 63
Insiders, 90 days
0
no open-market filings in 90 days
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no disclosures naming it
Big money
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none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $500.4MP/E 1442.0DIV YIELD —FCF YIELD 3.50%REV TTM $95.4M +35.8%NET INCOME $532K −76.2%NET CASH $47.5M52W 8.19 – 17.36SEC XBRL · TTM TO Invalid Date

How DCTH rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
68%
of sentences unchanged
Added
163
new sentences
Dropped
82
sentences removed
Length
+2,666
words, now 23,769

New in FY2025

  • As of December 31, 2025, we had $43.5 million in cash and cash equivalents and $47.6 million in short-term investments.
  • We have a substantial accumulated deficit and recurring operating losses in prior years.
  • For the years ended December 31, 2025 and 2024, we incurred a net gain of approximately $2.7 million and a net loss of $26.4 million, respectively, and notwithstanding any prior net gain, we may continue to incur losses in the future.
  • To date, we have funded our operations primarily through a combination of private placements and public offerings of our securities and debt financing, including convertible notes, as well as from revenue we have generated from HEPZATO and CHEMOSAT.
  • Our ability to generate additional product revenue from HEPZATO and CHEMOSAT, for any currently approved indications or any indications for which they are approved in the future, or future product candidates, if any, also depends on a number of additional factors, including, but not limited to, our ability to: • successfully commercialize and sell HEPZATO and CHEMOSAT pursuant to existing regulatory approvals; • successfully complete research and clinical development of future product candidates, 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, and obtain regulatory approval for those product candidates and indications, as applicable; • establish and maintain supply and manufacturing relationships, under commercially reasonable terms, with third parties, and ensure adequate, scaled up and legally compliant manufacturing of necessary components, including melphalan, bulk drug substances, drug products, and those used to manufacture the medical device, to maintain sufficient supply; • launch and commercialize any product candidates for which regulatory approval is obtained; • demonstrate the necessary safety data (and, if accelerated approval is obtained, verify the clinical benefit) post-approval to ensure continued regulatory approval; • obtain coverage and adequate product reimbursement from third-party payors, including government payors, for any approved products; • achieve market acceptance for any approved products; • establish, maintain, protect and enforce our intellectual property rights; and • attract, hire and retain qualified personnel.
  • In the absence of significant revenue from either or both of HEPZATO and CHEMOSAT, we may require substantial additional funding to continue the commercialization of HEPZATO in the United States, complete product development projects or clinical trials.
  • In addition, to the extent any outstanding warrants or stock options are exercised, this will also cause dilution.
  • We received approval by the FDA for HEPZATO in the United States in August 2023 and began generating revenue from product sales in 2024.
  • We must maintain or enter into acceptable arrangements for the supply of melphalan and other critical components of HEPZATO and CHEMOSAT and we may not be able to ensure adequate supply impacting our ability to successfully commercialize HEPZATO in the United States and CHEMOSAT in the European Union or complete any future clinical trials.
  • If any of these manufacturers fail to provide end-users with adequate supplies of melphalan or fail to comply with the requirements of regulatory authorities, we may be unable to successfully commercialize our product in the European Union.
  • To achieve commercial success for HEPZATO and any other product candidates, if approved, for which we retain sales and marketing responsibilities, we must either develop an effective sales and marketing organization or outsource these functions to other third parties.
  • In addition, since CHEMOSAT currently is approved for commercialization solely in the EU and limited other jurisdictions (including the United Kingdom), and HEPZATO is approved only in the United States, if we are unsuccessful in commercializing the products in the EU/UK and the United States, we will have no means of generating revenue.
  • The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, dissemination of off-label information, industry-sponsored scientific and educational activities and promotional activities, including such activities involving the Internet.
  • If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • We participate in governmental programs that impose extensive drug price reporting and payment obligations on pharmaceutical manufacturers.
  • Medicaid is a joint federal and state program that is administered by the states for low income and disabled beneficiaries.
  • Under the Medicaid Drug Rebate Program (the “MDRP”), as a condition of federal funds being made available for our covered outpatient drugs under Medicaid, we pay a rebate to state Medicaid programs for each unit of our covered outpatient drugs dispensed to a Medicaid beneficiary and paid for by the state Medicaid program.
  • Medicaid rebates are based on pricing data that we report on a monthly and quarterly basis to the CMS, the federal agency that administers the MDRP and Medicare programs.
  • For the MDRP, the data includes the Average Manufacturer Price (“AMP”) for each drug and, in the case of innovator products, best price.
  • In connection with Medicare Part B, we will continue to submit to Centers for Medicare and Medicaid Services (“CMS”) the average sales price (“ASP”) on a quarterly basis.
  • ASP is calculated based on a statutorily defined formula, as well as regulations and interpretations of the statute by CMS.
  • If we become aware that our MDRP price reporting submission for a prior period was incorrect or has changed as a result of recalculation of the pricing data, we must resubmit the corrected data for up to three years after those data originally were due.
  • If we fail to provide information on a timely basis or are found to have knowingly submitted false information to the government, we may be subject to civil monetary penalties and other sanctions, including termination from the MDRP, in which case payment would not be available for our covered outpatient drugs.
  • In addition, federal law requires that any company that participates in the MDRP also participate in the 340B program.
  • The 340B program is administered by Health Resources & Services Administration (“HRSA”) and requires us, as a participating manufacturer, to charge statutorily defined covered entities no more than the 340B “ ceiling price” for our covered outpatient drugs when used in an outpatient setting.
  • These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low income patients.
  • A drug that is designated for a rare disease or condition by the Secretary of HHS is not subject to the 340B ceiling price requirement if the sale is to one of the following types of covered entities: rural referral centers, sole community hospitals, critical access hospitals, and free standing cancer hospitals.
  • The 340B ceiling price is calculated using a statutory formula, which is based on the AMP and rebate amount for the covered outpatient drug as calculated under the MDRP.
  • We must report 340B ceiling prices to HRSA on a quarterly basis, and HRSA publishes them to 340B covered entities.
  • HRSA has finalized regulations regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities for 340B eligible drugs.
  • HRSA has also finalized a revised administrative dispute resolution process through which 340B covered entities may pursue claims against participating manufacturers for overcharges, and through which manufacturers may pursue claims against 340B covered entities for engaging in unlawful diversion or duplicate discounting of 340B drugs.
  • In order to be eligible to have drug products paid for with federal funds under Medicaid and Medicare Part B and purchased by certain federal agencies and grantees, we must also participate in the VA/FSS pricing program.
  • Under the VA/FSS program, we must report the Non-Federal Average Manufacturer Price (“Non-FAMP”) for our covered drugs to the VA and charge certain federal agencies no more than the Federal Ceiling Price, which is calculated based on Non-FAMP using a statutory formula.
  • These four agencies are the VA, the U.S.
  • Public Health Service (including the Indian Health Service).
  • We must also pay rebates on products purchased by military personnel and dependents through the TRICARE retail pharmacy program.
  • If we fail to provide timely information or are found to have knowingly submitted false information, we may be subject to civil monetary penalties.
  • Individual states continue to consider and have enacted legislation to limit the growth of healthcare costs, including the cost of prescription drugs and combination products.
  • A number of states have either implemented or are considering implementation of drug price transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies.
  • Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and factors considered in taking such increases, wholesale acquisition cost information disclosure to prescribers, purchasers, and state agencies, and new product notice and reporting.

and 123 more.

Gone since FY2024

  • As of December 31, 2024, we had $32.4 million in cash and cash equivalents and $20.8 million in short-term investments.
  • We have a substantial accumulated deficit and recurring operating losses.
  • We are not profitable and have incurred losses in each year since commencing operations.
  • For the years ended December 31, 2024 and 2023, we incurred net losses of approximately $26.4 million and $47.7 million, respectively, and may continue to incur losses in 2025.
  • To date, we have funded operations through a combination of private placements and public offerings of our securities and debt financing, including convertible notes, as well as revenue from HEPZATO and CHEMOSAT.
  • Our ability to generate additional product revenue from HEPZATO and CHEMOSAT or future product candidates, if any, also depends on a number of additional factors, including our ability to: • successfully commercialize and sell HEPZATO in the United States pursuant to our existing FDA approval; • successfully complete research and clinical development of future product candidates, 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, and obtain regulatory approval for those product candidates and indications, as applicable; • establish and maintain supply and manufacturing relationships, under commercially reasonable terms, with third parties, and ensure adequate, scaled up and legally compliant manufacturing of necessary components, including melphalan, bulk drug substances, drug products, and those used to manufacture the medical device, to maintain sufficient supply; • launch and commercialize any product candidates for which FDA approval is obtained; • demonstrate the necessary safety data (and, if accelerated approval is obtained, verify the clinical benefit) post-approval to ensure continued regulatory approval; • obtain coverage and adequate product reimbursement from third-party payors, including government payors, for any approved products; • achieve market acceptance for any approved products; • establish, maintain, protect and enforce our intellectual property rights; and • attract, hire and retain qualified personnel.
  • If we are not able to generate significant revenue from either or both of HEPZATO and CHEMOSAT, we may require additional substantial financing to further commercialize our products or to conduct future product development, if any, including clinical trials for new product candidates or for additional indications for which we do not currently have regulatory approval in the United States and the European Union, or in any other jurisdictions where we may receive regulatory approval.
  • In the absence of potential proceeds from cash exercises of currently outstanding warrants and/or significant revenue from either or both of HEPZATO and CHEMOSAT, we may require substantial additional funding to continue the commercialization of HEPZATO in the United States, complete product development projects or clinical trials.
  • 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.
  • In addition, the exercise of outstanding warrants and options will also cause dilution.
  • We received approval by the FDA for HEPZATO in the United States in August 2023 and began generating revenue from product sales during 2024.
  • We must maintain or enter into acceptable arrangements for the supply of melphalan and other critical components of HEPZATO and CHEMOSAT and we may not be able to ensure adequate supply impacting our ability to successfully commercialize HEPZATO in the United States and CHEMOSAT in the EU or complete any future clinical trials.
  • If any of these manufacturers fails to provide end-users with adequate supplies of melphalan or fails to comply with the requirements of regulatory authorities, we may be unable to successfully commercialize our product in the European Union.
  • To achieve commercial success for HEPZATO and any other product candidates, if approved, for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to other third parties.
  • In addition, since CHEMOSAT currently is approved for commercialization solely in the EU and limited other jurisdictions (including the United Kingdom), and HEPZATO is approved only in the United States, if we are unsuccessful in commercializing the products in the EU and the United States, we will have no means of generating revenue.
  • The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, dissemination of off-label information, industry-sponsored scientific and educational activities and promotional activities involving the Internet.
  • We have obtained the right to affix the CE Mark for the CHEMOSAT Hepatic Delivery System as a medical device for the delivery of melphalan in the EU.
  • Since we may only promote the device within this specific indication, if physicians are unable or unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EU will be significantly limited.
  • In the EU, CHEMOSAT is regulated as a Class III medical device indicated for the intra-arterial administration of a chemotherapeutic agent, melphalan hydrochloride, to the liver with additional extracorporeal filtration of the venous blood return.
  • To the extent that our promotion of CHEMOSAT is found to be outside the scope of its approved indication, we may be subject to fines or other regulatory action, limiting our ability to commercialize CHEMOSAT in the EU.
  • If physicians are unable or unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EU will be significantly limited.
  • However, no melphalan labels in the EU reference our product, and the labels vary from country to country with respect to the approved indication of the drug and its mode of administration.
  • As a result, the delivery of melphalan with our device may not be within the applicable label with respect to some indications in some Member States of the EU where the drugs are authorized for marketing.
  • If physicians are unable or unwilling to obtain melphalan separately from CHEMOSAT and/or to prescribe the use of melphalan independently, our sales opportunities in the EU will be significantly limited.
  • We are subject to significant ongoing regulatory obligations and oversight in the EU and the United States and will be in any other country where we receive marketing authorization or approval.
  • The commercial success of CHEMOSAT and HEPZATO will depend upon their acceptance by the medical community and third-party payors as clinically useful, cost effective and safe.
  • The laws that may affect our ability to operate include, but are not limited to: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; • HIPAA which created additional federal criminal statutes that prohibit knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services; • HIPAA, as amended by HITECH, and its implementing regulations, which impose certain requirements on covered entities, their respective business associates and covered subcontractors, and others relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the ACA, which requires manufacturers of drugs, devices, biologics and medical supplies to report to the HHS information related to certain payments and other transfers of value provided to physicians, (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information, such as Washington’s My Health My Data Act, or MHMD, in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
  • We and the third parties with whom we work are subject to stringent and evolving United States and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to information privacy and security.
  • Almost all states have enacted some sort of comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
  • For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020, (collectively, “CCPA”) applies to personal data of consumers, business representatives, and employees who are California residents, and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights.
  • For example, both the European Union ’ s General Data Protection Regulation (“EU GDPR”) and the United Kingdom’s GDPR (“UK GDPR”) define personal data to include any information that relates to an identified or identifiable natural person with identifiable health information carrying additional obligations, including obtaining the explicit consent from the individual for collection, use or disclosure of their information.
  • Under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million Euros under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.
  • In addition, we may transfer personal data from Europe and other jurisdictions to the United States or other countries and may be subject to EU regulations with respect to limiting the cross-border transfers of such data out of the European Economic Area (“EEA”) to the United States or other countries.
  • Preparing for and complying with information privacy and security laws has in the past and may in the future be time consuming, difficult and/or require us to devote significant resources.
  • If we or the third parties with whom we work fail, or are perceived to have failed, to comply with applicable laws, regulations or duties relating to the use, privacy or security of personal data we could be subject to significant consequences including: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data; reputational harm; or be forced to alter our business practices or change our business model.
  • 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.
  • In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system and efforts to control healthcare costs, including drug prices, that could have a significant negative impact on our business, including preventing, limiting or delaying regulatory approval of our drug candidates and reducing the sales and profits derived from our products once they are approved.
  • On August 16, 2022, the IRA was signed into law.
  • The new legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage.
  • Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (and the maximum price as a result of the negotiations becoming effective beginning on January 1, 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D for price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

and 42 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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