NVCR NovoCure Ltd

Quarterly net revenues of $139 million, up 13% year-over-year, with 3,845 active patients on therapy as of March 31, 2024

Phase 3 METIS trial in brain metastases from non-small cell lung cancer met primary endpoint and will be presented as late-breaking abstract at ASCO 2024

LUNAR PMA application for TTFields in NSCLC Day 100 FDA meeting complete

Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended March 31, 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 first quarter was a period of strong execution,” said William Doyle, Novocure’s Executive Chairman. “In Q1, GBM active patients grew 11%, we announced the METIS Phase 3 clinical trial met its primary endpoint, and we met with the U.S. Food and Drug Administration (FDA) in a Day-100 meeting for the LUNAR PMA application. We have multiple milestones ahead of us in 2024, and I remain grateful for our teams’ dedication and hard work.”

Financial updates for the first quarter ended March 31, 2024:

• Total net revenues for the quarter were $138.5 million, an increase of 13% compared to the same period in 2023. This increase was primarily driven by our successful launch in France and improved U.S. approval rates.
  • The United States, Germany and Japan contributed $90.5 million, $15.7 million and $7.8 million, respectively, with other active markets contributing $19.5 million.
  • Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
• Gross margin for the quarter was 76%.
• Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023. This primarily reflects decreased personnel expenses and reduced direct clinical trial expenses driven by the timing of activities within the clinical trial portfolio.
• Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023. This primarily reflects sales force expansion and increased marketing activities in anticipation of our potential launch in non-small cell lung cancer.
• General and administrative expenses for the quarter were $39.5 million, a decrease of 6% compared to the same period in 2023. This primarily reflects lower personnel expenses.
• Net loss for the quarter was $38.8 million with loss per share of $0.36.
• Adjusted EBITDA* for the quarter was $(4.6) million.
• Cash, cash equivalents and short-term investments were $870 million as of March 31, 2024.
• In May, we entered into a new five-year senior secured credit facility agreement with affiliates of Pharmakon Advisors for up to $400 million, drawn across up to four tranches of $100 million. This non-dilutive, multi-tranche, delayed-draw, debt facility strengthens our cash position and further solidifies our balance sheet while providing valuable flexibility as we invest in our future.

Operational updates for the first quarter ended March 31, 2024:

• 1,643 prescriptions were received in the quarter, an increase of 10% compared to the same period in 2023. Prescriptions from the United States, Germany and Japan contributed 990, 206 and 91 prescriptions, respectively, with the remaining 356 prescriptions received in other active markets.
• As of March 31, 2024, there were 3,845 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,137, 540 and 379 active patients, respectively, with the remaining 789 active patients contributed by other active markets.

Quarterly updates and achievements:

• In April, we met with the FDA in a Day-100 meeting for the PMA application for Optune Lua in non-small cell lung cancer (NSCLC). The meeting was productive with no indication that the PMA will be referred to an advisory panel. We continue to anticipate the PMA decision in the second half of 2024.
• In March 2024, we announced the METIS Phase 3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from NSCLC. The METIS trial data will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) scientific congress in June.
• In March, the FDA approved the Investigational New Drug (IND) application for the randomized, Phase 3 KEYNOTE D58 trial. KEYNOTE D58 will explore the use of TTFields therapy together with temozolomide and the immunotherapy pembrolizumab for the treatment of newly diagnosed glioblastoma.
• In March, an exploratory subgroup analysis of the randomized, Phase 3 INNOVATE-3 trial was selected as a Best Oral Presentation at the European Society of Gynaecological Oncology 2024 Congress. The exploratory analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel exhibited median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone.

Anticipated 2024 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 first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 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.

Consolidated Statements of Operations

USD in thousands (except share and per share data)

 

 

 

Three months ended March 31,

 

Year ended December 31,

 

 

2024

 

2023

 

2023

 

 

Unaudited

 

Audited

Net revenues

 

$

138,503

 

 

$

122,182

 

 

$

509,338

 

Cost of revenues

 

 

33,689

 

 

 

29,614

 

 

 

128,280

 

Gross profit

 

 

104,814

 

 

 

92,568

 

 

 

381,058

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

Research, development and clinical studies

 

 

51,598

 

 

 

59,704

 

 

 

223,062

 

Sales and marketing

 

 

55,206

 

 

 

51,169

 

 

 

226,809

 

General and administrative

 

 

39,530

 

 

 

41,944

 

 

 

164,057

 

Total operating costs and expenses

 

 

146,334

 

 

 

152,817

 

 

 

613,928

 

 

 

 

 

 

 

 

Operating income (loss)

 

 

(41,520

)

 

 

(60,249

)

 

 

(232,870

)

Financial income (expenses), net

 

 

9,878

 

 

 

9,169

 

 

 

41,130

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(31,642

)

 

 

(51,080

)

 

 

(191,740

)

Income taxes

 

 

7,118

 

 

 

1,981

 

 

 

15,303

 

Net income (loss)

 

$

(38,760

)

 

$

(53,061

)

 

$

(207,043

)

 

 

 

 

 

 

 

Basic and diluted net income (loss) per ordinary share

 

$

(0.36

)

 

$

(0.50

)

 

$

(1.95

)

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

 

 

107,266,198

 

 

 

105,667,072

 

 

 

106,391,178

 

Consolidated Balance Sheets

USD in thousands (except share data)

 

March 31, 2024

 

December 31, 2023

 

Unaudited

 

Audited

ASSETS

 

 

 

CURRENT ASSETS:

 

 

 

Cash and cash equivalents

$

453,763

 

$

240,821

Short-term investments

 

416,384

 

 

669,795

Restricted cash

 

3,600

 

 

1,743

Trade receivables, net

 

65,091

 

 

61,221

Receivables and prepaid expenses

 

21,479

 

 

22,677

Inventories

 

42,391

 

 

38,152

Total current assets

 

1,002,708

 

 

1,034,409

LONG-TERM ASSETS:

 

 

 

Property and equipment, net

 

58,917

 

 

51,479

Field equipment, net

 

11,911

 

 

11,384

Right-of-use assets

 

32,994

 

 

34,835

Other long-term assets

 

14,899

 

 

14,022

Total long-term assets

 

118,721

 

 

111,720

TOTAL ASSETS

$

1,121,429

 

$

1,146,129

Consolidated Balance Sheets

USD in thousands (except share data)

 

 

March 31, 2024

 

December 31, 2023

 

Unaudited

 

Audited

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

CURRENT LIABILITIES:

 

 

 

Trade payables

$

84,316

 

 

$

94,391

 

Other payables, lease liabilities and accrued expenses

 

75,914

 

 

 

84,724

 

Total current liabilities

 

160,230

 

 

 

179,115

 

LONG-TERM LIABILITIES:

 

 

 

Long-term debt, net

 

569,652

 

 

 

568,822

 

Long-term leases

 

25,608

 

 

 

27,420

 

Employee benefit liabilities

 

6,566

 

 

 

8,258

 

Other long-term liabilities

 

18

 

 

 

18

 

Total long-term liabilities

 

601,844

 

 

 

604,518

 

TOTAL LIABILITIES

 

762,074

 

 

 

783,633

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

Share capital -

 

 

 

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

107,603,774 shares and 107,075,754 shares at March 31, 2024 (unaudited) and December 31, 2023, respectively

 

—

 

 

 

—

 

Additional paid-in capital

 

1,387,765

 

 

 

1,353,468

 

Accumulated other comprehensive income (loss)

 

(4,147

)

 

 

(5,469

)

Retained earnings (accumulated deficit)

 

(1,024,263

)

 

 

(985,503

)

TOTAL SHAREHOLDERS' EQUITY

 

359,355

 

 

 

362,496

 

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

$

1,121,429

 

 

$

1,146,129

 

Non-U.S. GAAP financial measures reconciliation

USD in thousands

 

 

 

Three months ended March 31,

 

 

2024

 

2023

 

% Change

Net income (loss)

 

$

(38,760

)

 

$

(53,061

)

 

(27

)%

Add: Income tax

 

 

7,118

 

 

 

1,981

 

 

259

%

Add: Financial expenses (income), net

 

 

(9,878

)

 

 

(9,169

)

 

8

%

Add: Depreciation and amortization

 

 

2,815

 

 

 

2,722

 

 

3

%

EBITDA

 

$

(38,705

)

 

$

(57,527

)

 

(33

)%

Add: Share-based compensation

 

 

34,084

 

 

 

39,084

 

 

(13

)%

Adjusted EBITDA

 

$

(4,621

)

 

$

(18,443

)

 

(75

)%

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240502292080/en/

Investors & Media: Ingrid Goldberg investorinfo@novocure.com media@novocure.com 610-723-7427