UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report: June 5, 2017
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-16133 | 06-1245881 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
1633 Broadway, Suite 22C, New York, New York 10019
(Address of principal executive offices, including zip code)
(212) 489-2100
(Registrant’s telephone number, including area code)
NONE
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| ☐ | Emerging growth company |
| ☐ | If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for |
| complying with any new or revised financial accounting standards provided pursuant to section 13(a) of the Exchange Act. |
| Item 7.01 | Regulation FD Disclosure |
Delcath Systems, Inc. (the “Company”) is furnishing this Current Report on Form 8-K in connection with the disclosure of information contained in an investor presentation (the “Presentation”) used by the Company at its 2017 Annual Meeting of Stockholders. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K or other means. A copy of the Presentation is furnished herewith as Exhibit 99.1 and is incorporated into this Item 7.01 by reference.
The information furnished in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any registration statement filed pursuant to the Securities Act of 1933, as amended, except as may be expressly set forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the Presentation.
The Presentation is available on the Company’s investor relations website located at delcath.com/investors, although the Company reserves the right to discontinue that availability at any time.
| Item 8.01. | Other Events. |
As of the close of business on June 5, 2017, there were 374.4 million shares of the Company’s common stock outstanding.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit 99.1 | Investor Presentation dated June, 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Dated: June 5, 2017 | By: | /s/ Jennifer K. Simpson, Ph.D. | ||||
| Name: | Jennifer K. Simpson, Ph.D. | |||||
| Title: | President and Chief Executive Officer | |||||
EXHIBIT INDEX
| Exhibit 99.1 | Investor Presentation dated June, 2017. |
Delcath Annual Shareholder Meeting (NASDAQ: DCTH) June 5, 2017 Exhibit 99.1
Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future events and future financial performance which include statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which could cause actual results to differ materially from expected results, performance or achievements expressed or implied by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including, but not limited to, uncertainties relating to: our ability to repay and comply with the obligations under our senior secured convertible notes, the timing and results of future clinical trials including without limitation the OM, HCC, ICC, and mCRC trials in the Company’s Clinical Development Program, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system in various markets, including without limitation Germany and the United Kingdom and the impact on sales, if any, of reimbursement in these markets including ZE reimbursement in the German market, our ability to successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for patients with primary and metastatic disease in the liver, the Company's ability to satisfy the remaining requirements of the FDA's Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the Melphalan/HDS system by the U.S. FDA, the impact of presentations and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE, ESMO, EADO, RSNA) and future clinical results consistent with the data presented, approval of the current or future Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, and uncertainties regarding our ability to obtain financial and other resources for any clinical trials, research, development, and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission including the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form 10-K and our Reports on Form 10-Q and Form 8-K.
2016/2017 Highlights 2016 revenue increased 18% to $2.0 million; Q1 2017 increased 100% to $0.74 million; National reimbursement coverage in Germany under ZE system; 2016 SPA agreement and initiation of Phase 3 Trial in treatment of patients with ocular melanoma liver metastases 2017 SPA agreement with the U.S. Food and Drug Administration (FDA) for pivotal trial of in treatment of patients with intrahepatic cholangiocarcinoma (ICC); Publication in AJCO of results from single-center retrospective review finding that investigational percutaneous hepatic perfusion (PHP) with Melphalan/HDS offered promising results with a doubling of overall survival and significantly longer progression-free survival (PFS) and hepatic progression-free survival (HPFS) compared with other targeted therapies
Shareholder Value Through Clinical Development Program Tumor Type Milestones 201 HCC Trial (US Only) 202 HCC/ICC Trial (EU Only) ICC Data Release FOCUS Trial P3 Pivotal Study in Hepatic Dominant OM Interim Safety Analysis end 2017 FDA 2019 Ocular Melanoma (OM) Hepatocellular Carcinoma (HCC) Intrahepatic Cholangiocarcinoma (ICC) Pivotal Trial in ICC Enrollment to open in Q4 2017 Notes ICC Cohort Fully Enrolled HCC Remains Open for Enrollment Fastest Path to U.S. Market Approval Cost-effective trial design with minimal investment in 2017
Recent Data Provides Confidence Hepatic Progression-free and Overall Survival After Regional Therapy to the Liver for Metastatic Melanoma, Moffitt Cancer Center (AJCO) Analysis of 3 non-randomized approaches for treatment of 30 patients with liver metastases primarily resulting from ocular melanoma and skin melanoma. 10 PTS received PHP using melphalan 12 PTS received chemoembolization (CE) 6 received radioembolization with yttrium-90 (Y90) 2 PTS crossed over once their cancer progressed (1 from PHP to Y90; 1 from CE to PHP) Results: PHP with Melphalan/HDS – Median OS 608 days, median HPFS 361 days, median PFS at 245 days, Y90 - Median OS 295 days, median HPFS 54 days, median PFS 54 days CE – Median OS 265 days, median HPFS 80 days, median PFS 52 days Side effects following all treatments were similar, with most complications recorded as anorexia, abdominal pain, fatigue and nausea. Laboratory irregularities, such as thrombocytopenia and abnormal liver function tests, were seen immediately after treatment in some patients, but returned to baseline within a few days.
Recent Data Provides Confidence Percutaneous Hepatic Perfusion (PHP) for unresectable metastatic ocular melanoma to the liver: A Multi-institutional report of outcomes – Moffitt Cancer Center, University Hospital Southampton (Regional Therapies Symposium 2017) 49 PTS treated between 2008 and 2016; PTS received a total of 115 PHP TX (median TX = 2) Hepatic response to PHP was evaluable in 46 patients Results - 45.7 percent showed complete or partial response 37.0 percent had stable disease. Median overall survival was not reached, but was projected to be 657 days (1.8 years) Among patients with a complete or partial response, overall survival was projected to be 1,207 days (3.4 years) Most common side effects following treatment were anemia, thrombocytopenia and neutropenia.
Global Pivotal Trial in ICC Melphalan/HDS TX every 6-8 weeks ≤ 6 cycles GEM/CIS Re-Induction Primary Endpoint (Overall Survival) Secondary Endpoints (Progression Free Survival, Objective Response Rate, Safety) Screening Phase (N=295) R 1:1 Leveraging existing network of participating centers in Phase 3 OM Trial Sequential design requires minimal investment in 2017 A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma GEM/CIS Induction Phase (4 cycles)
CDP FOCUSED ON FASTEST PATH TO U.S. MARKET EU & US TAM Cancer Type Annual Incidence1 Eligible PTS2 Annual Potential Market Opportunity (Millions)3,4 Ocular Melanoma ~4,700 ~2,000 ~$80-$200 Intrahepatic Cholangiocarcinoma (ICC) ~14,000 ~9,300 ~$372-$930 Hepatocellular Carcinoma (HCC) 64,500 7,600-14,700 ~$304-$1,470 Colorectal (CRC) 411,000 40,000-55,000 ~$1,600-$5,500 Total EU & U.S. 494,200 58,900-81,000 ~$2,356-$8,100 Notes: Globocan, American Cancer Society LEK, Strategy&, Company Estimates Assumes 2-4TX/patient Assumes ~$20,000-$25,000 USD/TX Orphan Indications
European Commercialization Presence established in several major markets (~22 cancer centers) National reimbursement established after <3 years of commercial activity European centers producing data to support reimbursement applications in additional markets Commercial sales growing steadily; expanded reimbursement coverage in major EU countries required to expand commercial adoption
European Commercialization ~400 commercial procedures performed EU Physicians opting to retreat patients as familiarity/confidence grows UK Patient received record 8th TX in March 2017; SPIRE Southampton performed >100 TX Established network of treating centers participating in pivotal trials Data from EU experience providing steady flow of supporting abstracts and publications
Convertible Note $35.0 million senior secured convertible notes issued June 2016 subject to certain equity conditions Provided resources necessary for advancement of CDP where we believe shareholder value will be realized Recently executed warrant repurchase agreements with note holders; agreement for ~$7.9 million paid to holders in exchanged for warrant cancellation $12.6 million released; $11.8 million restricted cash remaining and scheduled to be released throughout 2017 Repayment using common shares began in December 2016; amortization is scheduled to continue through December 2017 Repayment in $2.5 million installments to the holders Anticipate repayment via shares at 15% discount to the lower of: Average of three lowest VWAPS from prior 20 trading days, or VWAP of the common stock on the trading day immediately preceding the installment date
Cash & Capital Resources Cash & Cash Equivalents $6.4 million at March 31, 2017 Debt $21.8 million at March 31, 2017 Restricted Cash $20.7 million at March 31, 2017 Shares Outstanding 167,883,231 million (168.5 million fully diluted1)2 at May 8, 2017 Fully diluted includes approximately 0.1 million options, 0.1 million unvested restricted shares and 0.4 million warrants Amortization of Convertible Note will cause delay in accurate calculation of market capitalization Focused Spending and Resources to Support Execution of Near-term Plan
