Docoh
Loading...

DCTH Delcath Systems

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product, HEPZATO KIT™ (melphalan hydrochloride for injection/hepatic delivery system), is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. HEPZATO KIT has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

Company profile

Ticker
DCTH
Exchange
Website
CEO
Jennifer Simpson
Employees
Incorporated
Location
Fiscal year end
Former names
DELCATH SYSTEMS INC
SEC CIK
IRS number
61245881

DCTH stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 May 21
31 Jul 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 26.6M 26.6M 26.6M 26.6M 26.6M 26.6M
Cash burn (monthly) 658.33K (positive/no burn) 2.24M 1.91M 1.52M 1.85M
Cash used (since last report) 2.64M n/a 9M 7.68M 6.11M 7.43M
Cash remaining 23.96M n/a 17.6M 18.92M 20.49M 19.17M
Runway (months of cash) 36.4 n/a 7.8 9.9 13.5 10.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
30 Jun 21 Rosalind Advisors Common Shares Buy Aquire P Yes No 12.76 5,500 70.18K 421,500
30 Jun 21 Steven A J Salamon Common Shares Buy Aquire P No No 12.76 5,500 70.18K 419,500
28 Jun 21 Steven A J Salamon Common Shares Buy Aquire P No No 11.56 5,000 57.8K 414,000
28 Jun 21 Rosalind Advisors Common Shares Buy Aquire P Yes No 11.56 500,000 5.78M 416,000
28 Jun 21 Rosalind Advisors Common Shares Buy Aquire P Yes No 11.56 5,000 57.8K 416,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

34.6% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 29 4 +625.0%
Opened positions 27 4 +575.0%
Closed positions 2 13 -84.6%
Increased positions 0 0
Reduced positions 1 0 NEW
13F shares
Current Prev Q Change
Total value 31.85M 29.81M +6.8%
Total shares 2.43M 1.72M +41.0%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Deerfield Management 500K $6.21M NEW
Flynn James E 500K $7.87M 0.0%
Rosalind Advisors 406.5K $5.05M NEW
Adage Capital Partners GP, L.L.C. 250K $3.11M NEW
Vanguard 247.7K $3.08M NEW
Schonfeld Strategic Advisors 109.24K $1.36M NEW
Marshall Wace North America 53.37K $663K NEW
Altrinsic Global Advisors 50K $621K NEW
MS Morgan Stanley 46.64K $580K NEW
Ikarian Capital 43.92K $546K NEW
Largest transactions
Shares Bought/sold Change
Altium Capital Management 0 -716.15K EXIT
Deerfield Management 500K +500K NEW
Rosalind Advisors 406.5K +406.5K NEW
Silverarc Capital Management 40K -311.62K -88.6%
Adage Capital Partners GP, L.L.C. 250K +250K NEW
Vanguard 247.7K +247.7K NEW
Hudson Bay Capital Management 0 -156.87K EXIT
Schonfeld Strategic Advisors 109.24K +109.24K NEW
Marshall Wace North America 53.37K +53.37K NEW
Altrinsic Global Advisors 50K +50K NEW

Financial report summary

?
Risks
  • The “Novel Coronavirus Disease 2019” (“COVID-19”) pandemic has materially and adversely affected our clinical trial operations and may materially and adversely affect our financial results.
  • Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern as of December 31, 2020.
  • Drug development is an inherently uncertain process with a high risk of failure at every stage of development. We received a complete response letter from the FDA declining to approve our existing New Drug Application, or NDA, in its current form.
  • The Company does not expect to generate significant revenue for the foreseeable future.
  • Continuing losses may exhaust our capital resources.
  • If we cannot raise additional capital, our potential to generate future revenues will be significantly limited since we may not be able to further commercialize CHEMOSAT and HEPZATO, complete our clinical trials or conduct future product development and clinical trials.
  • Our failure to obtain, or delays in obtaining, regulatory approvals may have a material adverse effect on our business, financial condition and results of operations.
  • 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. Since we may only promote the device within this specific indication, if physicians are unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EU will be significantly limited.
  • We are subject to significant ongoing regulatory obligations and oversight in the EU and will be subject to such obligations in any other country where we receive marketing authorization or approval.
  • The development and approval process in the United States could take many years, require substantial resources and may never lead to the approval of HEPZATO by the FDA for use in the United States.
  • Even if we obtain regulatory approval for HEPZATO in the United States, our ability to market HEPZATO would be limited to those uses that are approved.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
  • We rely on third parties to conduct certain elements of the clinical trials for CHEMOSAT and HEPZATO, and if they do not perform their obligations to us, we may not be able to obtain regulatory approvals for our system.
  • Purchasers of CHEMOSAT in the EU may not receive third-party reimbursement or such reimbursement may be inadequate. Without adequate reimbursement, commercialization of CHEMOSAT in the EU may not be successful.
  • CHEMOSAT and HEPZATO may not achieve sufficient acceptance by the medical community to sustain our business.
  • We may be subject, directly or indirectly, to federal and state health care 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.
  • Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult and costly, particularly in light of increased focus on privacy issues in countries around the world, including the U.S. and the EU.
  • Changes in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well as health care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.
  • Consolidation in the healthcare industry could lead to demands for price concessions.
  • Risks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
  • If we cannot maintain or enter into acceptable arrangements for the production of melphalan and other chemotherapeutic agents, we will be unable to successfully commercialize HEPZATO in the United States or complete our global Phase 3 trial in ocular melanoma liver metastases or any future clinical trials.
  • If we cannot successfully manufacture CHEMOSAT and HEPZATO, our ability to develop and commercialize the system would be impaired.
  • We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT and HEPZATO.
  • Even if we receive FDA or other foreign regulatory approvals, we may be unsuccessful in commercializing CHEMOSAT and HEPZATO in markets outside the EU, because of inadequate infrastructure or an ineffective commercialization strategy.
  • Our plan to use collaborative arrangements with third parties to help finance and to market and sell CHEMOSAT and HEPZATO may not be successful.
  • If we fail to overcome the challenges inherent in international operations, our business and results of operations may be materially adversely affected.
  • Rapid 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.
  • Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.
  • We have not and may not be able to adequately protect our intellectual property rights throughout the world.
  • Obtaining 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.
  • Our 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.
  • Our success depends in part on our ability to commercialize CHEMOSAT and HEPZATO prior to the expiration of our patent protection.
  • 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.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies.
  • Our trademarks may be infringed or successfully challenged, resulting in harm to our business.
  • We may rely primarily on trade secret protection for important proprietary technologies.
  • We 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 non-competition or non-solicitation agreements with our competitors.
  • Risks Related to Our Common Stock
  • The 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.
  • We have a history of reverse splits, which have severely impacted our common stock price.
  • Anti-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.
  • We 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.
  • The loss of key personnel could adversely affect our business.
  • We rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations.
  • Any current or future outbreak of a health epidemic or other adverse public health developments, such as the current outbreak of COVID-19, could disrupt our manufacturing and supply chain, and adversely affect our business and operating results.
Content analysis
?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. freshman Avg
New words: absence, Adequate, arm, attractive, BAC, booked, bound, cardiac, Care, Center, checkpoint, CHEMOSTAT, CI, commonly, criteria, crossover, DCR, demonstrate, DOR, endpoint, event, exceed, experience, experimental, exploratory, forced, government, improvement, inhibitor, Interval, invoice, ITT, jurisdiction, leukopenia, lose, Median, meeting, milestone, modified, moiety, neutropenia, ORR, OS, outlined, partly, partner, peer, pertaining, PFS, pharmacokinetic, pooled, population, powered, predefined, preliminary, prespecified, protocol, quality, randomized, rarity, resolved, restart, royalty, Rueckert, Secondary, single, statistical, statistically, studied, superior, Supply, survival, thrombocytopenia, uncertainty, upper, uveal, volatility, William
Removed: accredited, adjusted, adjustment, aggregated, Aid, allocated, announce, ASC, assuming, August, began, bipartisan, cancellation, CDP, closed, closing, collectively, commercially, connection, consummated, conversion, correct, create, curtail, declared, decline, decreased, deducting, deduction, directed, discount, economic, economy, effected, eligible, entered, entitled, exchanged, existing, expire, fall, federal, fully, gain, grant, guarantee, headcount, hierarchy, holder, hundred, ICC, incentive, individual, institutional, instrument, intended, international, investor, involve, issue, level, maximum, Mine, Nasdaq, nonqualified, NYC, offering, paid, par, placement, portion, Promissory, provision, realized, receive, reclassification, reduced, relief, reverse, Secured, Security, sell, Senior, small, split, sponsorship, state, stated, statute, stimulate, subsequently, sufficient, surrender, taxable, trading, transfer, trillion, Trump, underwriting, underwritten, Unobservable, variety, waiver