NVCR NovoCure Ltd

Quarterly net revenues of $150 million, up 19% year-over-year, with 3,963 active patients on therapy as of June 30, 2024

Positive results from Phase 3 METIS trial in brain metastases from non-small cell lung cancer presented at ASCO 2024

Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended June 30, 2024. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

“The second quarter was a period of consistent execution at Novocure,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipelines. I am pleased to share we have made significant progress on all fronts this quarter.”

Financial updates for the second quarter ended June 30, 2024:

• Total net revenues for the quarter were $150.4 million, an increase of 19% compared to the same period in 2023. This increase is primarily driven by our successful launch in France and improved U.S. approval rates.
  • The United States, Germany, France and Japan contributed $95.7 million, $15.1 million, $14.3 million and $7.7 million, respectively, with other active markets contributing $11.8 million.
  • Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
  • Improved approval rates in the U.S. resulted in $5.0 million of increased net revenue from prior period claims during the quarter. In addition, we received $2.6 million in net revenues from a private payer in the United Kingdom where payments are not routine. We do not expect these two benefits, totaling $7.6 million, to recur.
• Gross margin for the quarter was 77%.
• Research, development and clinical studies expenses for the quarter were $55.0 million, a decrease of 1% from the same period in 2023.
• Sales and marketing expenses for the quarter were $56.6 million, a decrease of 3% compared to the same period in 2023. This primarily reflects lower personnel expenses associated with support functions.
• General and administrative expenses for the quarter were $37.7 million, a decrease of 8% compared to the same period in 2023. This primarily reflects lower personnel expenses.
• Net loss for the quarter was $33.4 million with loss per share of $0.31.
• Adjusted EBITDA* for the quarter was $1.1 million.
• Cash, cash equivalents and short-term investments were $951.2 million as of June 30, 2024.

Operational updates for the second quarter ended June 30, 2024:

• 1,634 prescriptions were received in the quarter, an increase of 5% compared to the same period in 2023. Prescriptions from the United States, Germany, France and Japan contributed 957, 206, 176 and 108 prescriptions, respectively, with the remaining 187 prescriptions received in other active markets.
• As of June 30, 2024, there were 3,963 active patients on therapy, an increase of 11% compared to the same period in 2023. Active patients from the United States, Germany, France and Japan contributed 2,175, 538, 369 and 403 active patients, respectively, with the remaining 478 active patients contributed by other active markets.

Quarterly updates and achievements:

• In June, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
• In June, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO annual meeting. TIGER investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany. The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial. TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.

Anticipated clinical milestones:

• Top-line data from phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)

Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, July 25, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

*Non-GAAP Financial Measurements

We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

 

Three months ended June 30,

 

Six months ended June 30,

 

Year ended December 31,

 

2024

 

2023

 

2024

 

2023

 

2023

 

Unaudited

 

Unaudited

 

Audited

Net revenues

$

150,356

 

 

$

126,051

 

 

$

288,859

 

 

$

248,233

 

 

$

509,338

 

Cost of revenues

 

34,654

 

 

 

34,018

 

 

 

68,343

 

 

 

63,632

 

 

 

128,280

 

Gross profit

 

115,702

 

 

 

92,033

 

 

 

220,516

 

 

 

184,601

 

 

 

381,058

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

Research, development and clinical studies

 

54,955

 

 

 

55,427

 

 

 

106,553

 

 

 

115,131

 

 

 

223,062

 

Sales and marketing

 

56,616

 

 

 

58,488

 

 

 

111,822

 

 

 

109,657

 

 

 

226,809

 

General and administrative

 

37,711

 

 

 

40,778

 

 

 

77,241

 

 

 

82,722

 

 

 

164,057

 

Total operating costs and expenses

 

149,282

 

 

 

154,693

 

 

 

295,616

 

 

 

307,510

 

 

 

613,928

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

(33,580

)

 

 

(62,660

)

 

 

(75,100

)

 

 

(122,909

)

 

 

(232,870

)

Financial income (expenses), net

 

10,851

 

 

 

8,756

 

 

 

20,729

 

 

 

17,925

 

 

 

41,130

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income tax

 

(22,729

)

 

 

(53,904

)

 

 

(54,371

)

 

 

(104,984

)

 

 

(191,740

)

Income tax

 

10,646

 

 

 

3,514

 

 

 

17,764

 

 

 

5,495

 

 

 

15,303

 

Net income (loss)

$

(33,375

)

 

$

(57,418

)

 

$

(72,135

)

 

$

(110,479

)

 

$

(207,043

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net income (loss) per ordinary share

$

(0.31

)

 

$

(0.54

)

 

$

(0.67

)

 

$

(1.04

)

 

$

(1.95

)

Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share

 

107,700,284

 

 

 

106,289,073

 

 

 

107,483,241

 

 

 

105,979,791

 

 

 

106,391,178

 

Consolidated Balance Sheets

USD in thousands (except share data)

      

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share data)

 

June 30, 2024

 

December 31, 2023

 

Unaudited

 

Audited

ASSETS

 

 

 

CURRENT ASSETS:

 

 

 

Cash and cash equivalents

$

164,796

 

$

240,821

Short-term investments

 

786,390

 

 

669,795

Restricted cash

 

3,647

 

 

1,743

Trade receivables, net

 

64,703

 

 

61,221

Receivables and prepaid expenses

 

32,858

 

 

22,677

Inventories

 

40,442

 

 

38,152

Total current assets

 

1,092,836

 

 

1,034,409

LONG-TERM ASSETS:

 

 

 

Property and equipment, net

 

66,477

 

 

51,479

Field equipment, net

 

11,719

 

 

11,384

Right-of-use assets

 

29,076

 

 

34,835

Other long-term assets

 

12,062

 

 

14,022

Total long-term assets

 

119,334

 

 

111,720

TOTAL ASSETS

$

1,212,170

 

$

1,146,129

Consolidated Balance Sheets

USD in thousands (except share data)

 

 

June 30, 2024

 

December 31, 2023

 

Unaudited

 

Audited

The accompanying notes are an integral part of these unaudited consolidated financial statements.

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

CURRENT LIABILITIES:

 

 

 

Trade payables

$

90,171

 

 

$

94,391

 

Other payables, lease liabilities and accrued expenses

 

79,007

 

 

 

84,724

 

Total current liabilities

 

169,178

 

 

 

179,115

 

LONG-TERM LIABILITIES:

 

 

 

Convertible note

 

556,508

 

 

 

568,822

 

Senior secured credit facility, net

 

96,962

 

 

 

—

 

Long-term leases

 

21,731

 

 

 

27,420

 

Employee benefit liabilities

 

6,023

 

 

 

8,258

 

Other long-term liabilities

 

18

 

 

 

18

 

Total long-term liabilities

 

681,242

 

 

 

604,518

 

TOTAL LIABILITIES

 

850,420

 

 

 

783,633

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

Share capital -

 

 

 

Ordinary shares no par value, unlimited shares authorized; issued and outstanding:

108,013,830 shares and 107,075,754 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively

 

—

 

 

 

—

 

Additional paid-in capital

 

1,422,903

 

 

 

1,353,468

 

Accumulated other comprehensive income (loss)

 

(3,515

)

 

 

(5,469

)

Retained earnings (accumulated deficit)

 

(1,057,638

)

 

 

(985,503

)

TOTAL SHAREHOLDERS' EQUITY

 

361,750

 

 

 

362,496

 

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

$

1,212,170

 

 

$

1,146,129

 

Non-U.S. GAAP financial measures reconciliation

USD in thousands

 

 

Three months ended June 30,

 

Six months ended June 30,

 

2024

 

2023

 

% Change

 

2024

 

2023

 

% Change

Net income (loss)

$

(33,375

)

 

$

(57,418

)

 

(42

)%

 

$

(72,135

)

 

$

(110,479

)

 

(35

)%

Add: Income tax

 

10,646

 

 

 

3,514

 

 

203

%

 

 

17,764

 

 

 

5,495

 

 

223

%

Add: Financial expenses (income), net

 

(10,851

)

 

 

(8,756

)

 

24

%

 

 

(20,729

)

 

 

(17,925

)

 

16

%

Add: Depreciation and amortization

 

2,858

 

 

 

2,721

 

 

5

%

 

 

5,673

 

 

 

5,443

 

 

4

%

EBITDA

$

(30,722

)

 

$

(59,939

)

 

(49

)%

 

$

(69,427

)

 

$

(117,466

)

 

(41

)%

Add: Share-based compensation

 

31,830

 

 

 

32,740

 

 

(3

)%

 

 

65,914

 

 

 

71,824

 

 

(8

)%

Adjusted EBITDA

$

1,108

 

 

$

(27,199

)

 

(104

)%

 

$

(3,513

)

 

$

(45,642

)

 

(92

)%

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240725581079/en/

Investors & Media: Ingrid Goldberg investorinfo@novocure.com media@novocure.com