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Delcath Systems Reports Third Quarter 2024 Results and Business Highlights

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Delcath Systems (NASDAQ: DCTH) reported strong Q3 2024 results with total revenue of $11.2 million, up 44% from previous quarter. This includes $10.0 million from HEPZATO KIT™ and $1.2 million from CHEMOSAT®. The company activated four new HEPZATO treatment centers in Q3 and one in October, reaching twelve active centers total. Cash position stood at $14.0 million with quarterly burn of $3.6 million. Post-quarter, Delcath cleared all debt obligations and received approximately $25 million from warrant exercises. R&D expenses decreased to $3.9 million from $4.7 million year-over-year, while SG&A expenses increased to $7.0 million from $6.2 million due to commercial launch activities.

Delcath Systems (NASDAQ: DCTH) ha riportato risultati solidi per il terzo trimestre del 2024, con un fatturato totale di 11,2 milioni di dollari, in aumento del 44% rispetto al trimestre precedente. Questo include 10,0 milioni di dollari provenienti da HEPZATO KIT™ e 1,2 milioni di dollari da CHEMOSAT®. L'azienda ha attivato quattro nuovi centri di trattamento HEPZATO nel terzo trimestre e uno a ottobre, raggiungendo un totale di dodici centri attivi. La posizione di cassa ammontava a 14,0 milioni di dollari con un consumo trimestrale di 3,6 milioni di dollari. Dopo il trimestre, Delcath ha estinto tutte le obbligazioni debitorie e ha ricevuto circa 25 milioni di dollari da esercizi di warrant. Le spese per R&D sono diminuite a 3,9 milioni di dollari da 4,7 milioni di dollari su base annua, mentre le spese SG&A sono aumentate a 7,0 milioni di dollari da 6,2 milioni di dollari a causa delle attività di lancio commerciale.

Delcath Systems (NASDAQ: DCTH) reportó resultados sólidos para el tercer trimestre de 2024, con ingresos totales de 11,2 millones de dólares, un aumento del 44% con respecto al trimestre anterior. Esto incluye 10,0 millones de dólares de HEPZATO KIT™ y 1,2 millones de dólares de CHEMOSAT®. La compañía activó cuatro nuevos centros de tratamiento HEPZATO en el tercer trimestre y uno en octubre, alcanzando un total de doce centros activos. La posición de caja se situó en 14,0 millones de dólares con un gasto trimestral de 3,6 millones de dólares. Después del trimestre, Delcath saldó todas las obligaciones de deuda y recibió aproximadamente 25 millones de dólares por ejercicios de warrants. Los gastos en I+D disminuyeron a 3,9 millones de dólares desde 4,7 millones de dólares en comparación con el año anterior, mientras que los gastos SG&A aumentaron a 7,0 millones de dólares desde 6,2 millones de dólares debido a las actividades de lanzamiento comercial.

Delcath Systems (NASDAQ: DCTH)는 2024년 3분기에 총 수익 1,120만 달러를 기록하며 전 분기 대비 44% 증가한 강력한 실적을 발표했습니다. 여기에는 HEPZATO KIT™에서 1,000만 달러와 CHEMOSAT®에서 120만 달러가 포함됩니다. 회사는 3분기에 네 개의 새로운 HEPZATO 치료 센터를 활성화했으며, 10월에는 하나를 추가하여 총 12개의 활성 센터에 도달했습니다. 현금 보유액은 1,400만 달러에 달하며 분기별 소모액은 360만 달러입니다. 분기 후 Delcath는 모든 부채 의무를 상환하였고 약 2,500만 달러를 워런트 행사로 수령했습니다. 연구개발 비용은 전년 대비 470만 달러에서 390만 달러로 감소한 반면, 판매관리비는 상업적 출시 활동으로 인해 620만 달러에서 700만 달러로 증가했습니다.

Delcath Systems (NASDAQ: DCTH) a annoncé des résultats solides pour le troisième trimestre 2024 avec un chiffre d'affaires total de 11,2 millions de dollars, en hausse de 44 % par rapport au trimestre précédent. Cela comprend 10,0 millions de dollars provenant de HEPZATO KIT™ et 1,2 million de dollars de CHEMOSAT®. L'entreprise a activé quatre nouveaux centres de traitement HEPZATO au troisième trimestre et un en octobre, atteignant un total de douze centres actifs. La position de trésorerie s'élevait à 14,0 millions de dollars, avec une consommation trimestrielle de 3,6 millions de dollars. Après le trimestre, Delcath a réglé toutes ses obligations de dette et a reçu environ 25 millions de dollars grâce à des exercices de warrants. Les dépenses de R&D ont diminué à 3,9 millions de dollars contre 4,7 millions de dollars l'année précédente, tandis que les dépenses SG&A ont augmenté à 7,0 millions de dollars contre 6,2 millions de dollars en raison des activités de lancement commercial.

Delcath Systems (NASDAQ: DCTH) berichtete über starke Ergebnisse für das 3. Quartal 2024 mit einem Gesamterlös von 11,2 Millionen Dollar, was einem Anstieg von 44 % im Vergleich zum Vorquartal entspricht. Dies umfasst 10,0 Millionen Dollar aus HEPZATO KIT™ und 1,2 Millionen Dollar aus CHEMOSAT®. Das Unternehmen aktivierte im 3. Quartal vier neue HEPZATO-Behandlungszentren und eines im Oktober, sodass insgesamt zwölf aktive Zentren erreicht wurden. Die Liquiditätsposition lag bei 14,0 Millionen Dollar mit einem Quartalsverlust von 3,6 Millionen Dollar. Nach dem Quartal tilgte Delcath alle Schulden und erhielt etwa 25 Millionen Dollar aus der Ausübung von Warrants. Die F&E-Ausgaben sanken im Jahresvergleich von 4,7 Millionen Dollar auf 3,9 Millionen Dollar, während die SG&A-Ausgaben aufgrund kommerzieller Aktivitäten auf 7,0 Millionen Dollar von 6,2 Millionen Dollar anstiegen.

Positive
  • Revenue growth of 44% quarter-over-quarter to $11.2 million
  • Expansion to twelve active treatment centers
  • Elimination of all debt obligations
  • Receipt of $25 million from warrant exercises
  • Reduced R&D expenses year-over-year
  • Strong clinical results from multiple independent studies
Negative
  • Increased SG&A expenses due to commercial launch costs
  • Quarterly cash burn of $3.6 million

Insights

The Q3 results show impressive commercial traction with $11.2 million in total revenue, a 44% sequential increase. HEPZATO KIT generated $10.0 million in U.S. sales, demonstrating strong market adoption. The company's financial position has significantly improved with $25 million from warrant exercises and debt elimination. With a quarterly cash burn of $3.6 million and growing revenues, the path to profitability appears achievable. The expansion of treatment centers from 8 to 12, with more in the pipeline, suggests continued revenue growth potential. The clean balance sheet and robust commercial momentum position Delcath well for pipeline expansion into additional indications.

Recent clinical data strengthens HEPZATO's market position. The FOCUS trial subgroup analyses demonstrate consistent efficacy regardless of extrahepatic lesions or prior therapy history. Multiple independent studies validate the treatment's effectiveness:

  • Moffitt's 30-patient study showed superior liver disease control compared to alternatives
  • Tübingen's 167-patient study confirmed survival benefits as first-line therapy
  • Leipzig's study reported 91% hepatic disease control rate across multiple cancer types
The expansion into colorectal and breast cancers represents significant market opportunities beyond the current uveal melanoma indication.

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

QUEENSBURY, N.Y.--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the third quarter ended September 30, 2024.

Third Quarter and Recent Business Highlights

  • Total third quarter revenues of $11.2 million, up 44% from the prior quarter, including $10.0 million from HEPZATO KIT™ (melphalan/Hepatic Delivery System) and $1.2 million from CHEMOSAT®;
  • Activated four HEPZATO treatment centers in the U.S. during the third quarter and one more in October, bringing the total to twelve active centers; another center has scheduled their first treatment in November with a further 10 centers having partially or fully completed preceptorship training;
  • Reported that CHOPIN, an investigator-initiated study which is evaluating the effect of sequencing immunotherapy with CHEMOSAT liver directed therapy, is now fully enrolled with 76 patients;
  • Ended the third quarter with cash and investments of $14.0 million with quarterly cash burn of $3.6 million; and
  • Subsequent to September 30, 2024:
    • Submitted the final principal and interest payments of $2.8 million on the Rosalind note payable and as a result have no outstanding debt obligations; and
    • All remaining Tranche B warrants from the March 29, 2023 PIPE were exercised by the November 6, 2024 expiration date resulting in approximately $25 million in proceeds.

“We are pleased with HEPZATO's robust market adoption in the U.S., a testament to its clinical impact and the confidence physicians are showing in its use,” said Gerard Michel, Delcath’s Chief Executive Officer. “Given our strong balance sheet and consistent revenue growth, which puts us on the cusp of profitability, Delcath is in a solid position to expand our development pipeline. Based on broad interest from oncology leaders, we are advancing programs for the use of HEPZATO in liver dominant colorectal and breast cancers.”

Recent Publications

  • Presented subgroup analyses data from the FOCUS Phase 3 trial of HEPZATO at ESMO 2024, demonstrating similar outcomes in overall survival, overall response rate, and progression free survival between patients with and without extrahepatic lesions or based on prior therapy. In addition, tumor responses were observed throughout the entire treatment period supporting the strategy to continue treatment until best response is achieved;
  • Announced multiple independent investigator-sponsored retrospective studies of HEPZATO and CHEMOSAT:
    • A 30-patient study published in the Annals of Surgical Oncology by researchers at Moffitt Cancer Center in Tampa, Florida. The study reported that HEPZATO used in first- or second-line therapy for metastatic uveal melanoma provided better disease control in the liver and improved progression-free survival compared to both immunotherapy and other liver-directed therapies;
    • A 167-patient study published in the journal Therapeutic Advances in Medical Oncology by investigators from the University of Tübingen, Germany. The study reported that first-line liver-directed therapies, including CHEMOSAT, significantly improve melanoma-specific survival in patients with liver metastases from uveal melanoma, compared to first-line systemic therapies; and
    • A study published in the ESMO journal of Gastrointestinal Oncology by researchers from the University Hospital of Leipzig reporting the results of 33 patients treated with CHEMOSAT. The study included previously treated patients with unresectable intrahepatic metastases from seven different cancer types and reported a hepatic disease control rate of 91% with six patients (18.2%) achieving complete response in the liver. Median hepatic progression-free survival was 52 weeks across all patients.

Third Quarter 2024 Results

Total revenue for the quarter ended September 30, 2024 was $11.2 million compared to $0.4 million for the same period in the prior year. Revenue includes sales of $10.0 million of HEPZATO in the U.S. and $1.2 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ended September 30, 2024, were $3.9 million compared to $4.7 million for the same period in the prior year. The change in research and development expenses is primarily due to lower costs associated with expanded access protocol incurred in previous periods offset by an increase in medical affairs and regulatory costs associated with an approved product.

Selling, general and administrative expenses for the quarter ended September 30, 2024, were $7.0 million compared to $6.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

The Company submitted the final principal payment due to Avenue Venture Opportunities Fund, L.P. on August 1, 2024 for the Loan and Security Agreement entered into in August 2021. As of September 30, 2024 our cash and investments totaled $14.0 million.

Subsequent to the end of the third quarter, we submitted the final principal and interest payment of $2.8 million on the outstanding Rosalind note payable and received approximately $25 million in proceeds from the exercise of Tranche B Warrants from the previous March 29, 2023 PIPE. Currently, there are no outstanding debt obligations.

Conference Call Information

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

Event Date:

Friday, November 8, 2024

Time:

8:30 AM Eastern Time

 

 

Participant Numbers

 

Toll Free:

1-877-407-3982

International:

1-201-493-6780

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1691899&tp_key=9d94cb0736

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://delcath.com/investors/events-presentations/

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 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 Hepatic Delivery System (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

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, 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; 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.

 

DELCATH SYSTEMS, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

 

 

September 30,
2024

 

December 31,
2023

Assets

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

8,315

 

$

12,646

Restricted cash

 

 

 

50

Short-term investments

 

5,677

 

 

19,808

Accounts receivable, net

 

6,936

 

 

241

Inventory

 

6,642

 

 

3,322

Prepaid expenses and other current assets

 

1,312

 

 

1,091

Total current assets

 

28,882

 

 

37,158

Property, plant and equipment, net

 

1,729

 

 

1,352

Right-of-use assets

 

1,070

 

 

103

Total assets

$

31,681

 

$

38,613

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities

 

 

 

Accounts payable

$

937

 

$

1,012

Accrued expenses

 

5,706

 

 

5,249

Lease liabilities, current

 

107

 

 

37

Loan payable

 

 

 

5,239

Convertible notes payable

 

2,000

 

 

4,911

Warrant liability - current

 

12,834

 

 

Total current liabilities

 

21,584

 

 

16,448

Warrant liability, non-current

 

 

 

5,548

Lease Liabilities, non-current

 

963

 

 

Other liabilities, non-current

 

563

 

 

840

Total liabilities

$

23,110

 

$

22,836

Commitments and contingencies

 

 

 

Stockholders’ equity

 

 

 

Preferred stock, $0.01 par value; 10,000,000 shares authorized; 12,342 and 24,819
shares issued and outstanding at September 30, 2024 and December 31,
2023, respectively

 

 

 

Common stock, $0.01 par value; 80,000,000 shares authorized; 28,019,599 shares and
22,761,554 shares issued and outstanding at September 30, 2024 and December 31,
2023, respectively

 

280

 

 

228

Additional paid-in capital

 

536,430

 

 

520,576

Accumulated deficit

 

(528,150)

 

 

(505,162)

Accumulated other comprehensive income

 

11

 

 

135

Total stockholders’ equity

 

8,571

 

 

15,777

Total liabilities and stockholders’ equity

$

31,681

 

$

38,613

 

DELCATH SYSTEMS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

 

Three months ended September 30,

 

Nine months ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

Product revenue

$

11,200

 

$

434

 

$

22,105

 

$

1,526

Cost of goods sold

 

(1,640)

 

 

(133)

 

 

(4,062)

 

 

(464)

Gross profit

 

9,560

 

 

301

 

 

18,043

 

 

1,062

Operating expenses:

 

 

 

 

 

 

 

Research and development expenses

 

3,866

 

 

4,662

 

 

10,960

 

 

12,793

Selling, general and administrative expenses

 

6,953

 

 

6,195

 

 

22,532

 

 

15,147

Total operating expenses

 

10,819

 

 

10,857

 

 

33,492

 

 

27,940

Operating loss

 

(1,259)

 

 

(10,556)

 

 

(15,449)

 

 

(26,878)

Change in fair value of warrant liability

 

2,975

 

 

(9,384)

 

 

(7,392)

 

 

(8,224)

Interest expense, net

 

113

 

 

(395)

 

 

(170)

 

 

(1,454)

Other (expense) income

 

35

 

 

(5)

 

 

23

 

$

14

Net income (loss)

 

1,864

 

 

(20,340)

 

 

(22,988)

 

 

(36,542)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

(14)

 

 

 

 

(147)

 

 

Foreign currency translation adjustments

 

17

 

 

5

 

 

23

 

 

24

Total comprehensive income (loss)

$

1,867

 

$

(20,335)

 

$

(23,112)

 

$

(36,518)

Common share data:

 

 

 

 

 

 

 

Basic income (loss) per common share

$

0.06

 

$

(1.14)

 

$

(0.84)

 

$

(2.61)

Weighted average number of basic shares outstanding

 

28,738,307

 

 

17,863,078

 

 

27,335,212

 

 

13,985,248

Diluted income (loss) per common share

$

0.06

 

$

(1.14)

 

$

(0.84)

 

$

(2.61)

Weighted average number of dilutive shares outstanding

 

32,345,672

 

 

17,863,078

 

 

27,335,212

 

 

13,985,248

 

Investor Relations:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What was Delcath Systems (DCTH) revenue in Q3 2024?

Delcath Systems reported total revenue of $11.2 million in Q3 2024, including $10.0 million from HEPZATO KIT™ and $1.2 million from CHEMOSAT®.

How many HEPZATO treatment centers did Delcath (DCTH) have active in Q3 2024?

Delcath had twelve active HEPZATO treatment centers by October 2024, having activated four centers in Q3 and one more in October.

What was Delcath's (DCTH) cash position in Q3 2024?

Delcath ended Q3 2024 with $14.0 million in cash and investments, with a quarterly cash burn of $3.6 million.

How much did Delcath (DCTH) receive from warrant exercises in Q3 2024?

Subsequent to Q3 2024, Delcath received approximately $25 million from the exercise of Tranche B Warrants from the March 29, 2023 PIPE.

Delcath Systems Inc

NASDAQ:DCTH

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