Novocure Reports Third Quarter 2024 Financial Results

Quarterly net revenues of $155 million, up 22% year-over-year, with record 4,113 active patients on therapy as of September 30, 2024

FDA approves Optune Lua for the treatment of metastatic non-small cell lung cancer

After 22 years as CEO, Asaf Danziger announces planned retirement at year end, will be succeeded by current CFO Ashley Cordova

Christoph Brackmann appointed Chief Financial Officer, effective January 1, 2025

Novocure (NASDAQ: NVCR) today reported financial results for the third quarter ended September 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).

"This was a period of strong execution and achievement at Novocure," said William Doyle, Novocure's Executive Chairman. "We secured FDA approval and launched Optune Lua for the treatment of patients with metastatic non-small cell lung cancer, achieved significant year-over-year revenue growth across our major markets, and solidified our management team to drive our next stage of growth. It is an exciting time to be at Novocure as we pursue opportunities to make a difference in the lives of our patients."

Financial updates for the third quarter ended September 30, 2024:

• Total net revenues for the quarter were $155.1 million, an increase of 22% 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 U.S., Germany, France and Japan contributed $98.3 million, $17.0 million, $15.2 million and $8.6 million, respectively, with other active markets contributing $11.3 million.
  • Improved approval rates in the U.S. resulted in $4.7 million of increased net revenue from prior period claims during the quarter. We do not expect this benefit to recur.
  • Revenue in Greater China from Novocure's partnership with Zai Lab totaled $4.6 million.
• Gross margin for the quarter was 77%.
• Research, development and clinical studies expenses for the quarter were $51.9 million, a decrease of 3% from the same period in 2023.
• Sales and marketing expenses for the quarter were $59.8 million, an increase of 3% compared to the same period in 2023.
• General and administrative expenses for the quarter were $40.1 million, a decrease of 4% compared to the same period in 2023.
• Net loss for the quarter was $30.6 million with loss per share of $0.28.
• Adjusted EBITDA* for the quarter was $1.7 million.
• Cash, cash equivalents and short-term investments were $959.9 million as of September 30, 2024.

Operational updates for the third quarter ended September 30, 2024:

• 1,586 prescriptions were received in the quarter, an increase of 8% compared to the same period in 2023. Prescriptions from the U.S., Germany, France and Japan contributed 934; 217; 171 and 99 prescriptions, respectively, with the remaining 165 prescriptions received in other active markets.
• As of September 30, 2024, there were a record 4,113 active patients on therapy. Active patients from the U.S., Germany, France and Japan contributed 2,200; 570; 393 and 437 active patients, respectively, with the remaining 513 active patients contributed by other active markets.

Quarterly updates and achievements:

• In October, based on the results from the Phase 3 LUNAR trial, the U.S. Food and Drug Administration (FDA) approved our Premarket Approval (PMA) application for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen. Our commercial launch in the U.S. is underway with physician certification ongoing and first prescription received shortly after approval.
• In October, the U.S. FDA granted Breakthrough Device designation for the use of TTFields therapy for brain metastases from non-small cell lung cancer. Breakthrough Device designation gives us more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of our marketing application upon filing, and expedited review of pre-PMA manufacturing and quality systems compliance inspections.
• In September, we announced the retirement of Chief Executive Officer (CEO) Asaf Danziger, effective January 1, 2025. Mr. Danziger will be succeeded by Chief Financial Officer (CFO) Ashley Cordova. In October, we appointed Christoph Brackmann to succeed Ms. Cordova as CFO, effective January 1, 2025. In addition, we announced the promotion of Mukund Paravasthu to the role of Chief Operating Officer, effective October 1, 2024.

Anticipated clinical milestones:

• Top-line data from Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
• Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
• Data from Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (2026)

Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2024 financial results at 8:00 a.m. EDT today, Wednesday, October 30, 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.

Novocure's global headquarters is located in Root Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located 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 September 30,								Nine months ended September 30,								Year ended December 31,
	2024				2023				2024				2023				2023
	Unaudited								Unaudited								Audited
Net revenues		155,095				127,321				443,954				375,554				509,338
Cost of revenues		35,372				32,092				103,715				95,724				128,280
Gross profit		119,723				95,229				340,239				279,830				381,058
Operating costs and expenses:
Research, development and clinical studies		51,882				53,623				158,435				168,754				223,062
Sales and marketing		59,830				57,964				171,652				167,621				226,809
General and administrative		40,103				41,887				117,344				124,609				164,057
Total operating costs and expenses		151,815				153,474				447,431				460,984				613,928
Operating income (loss)		(32,092				(58,245				(107,192				(181,154				(232,870
Financial income (expenses), net		10,507				10,023				31,236				27,948				41,130
Income (loss) before income tax		(21,585				(48,222				(75,956				(153,206				(191,740
Income tax		8,985				1,263				26,749				6,758				15,303
Net income (loss)		(30,570				(49,485				(102,705				(159,964				(207,043
Basic and diluted net income (loss) per ordinary share		(0.28				(0.46				(0.95				(1.51				(1.95
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share		108,247,716				106,772,814				107,679,501				106,219,194				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)
	September 30, 2024			December 31, 2023
	Unaudited			Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		185,422			240,821
Short-term investments		774,476			669,795
Restricted cash		3,777			1,743
Trade receivables, net		67,060			61,221
Receivables and prepaid expenses		25,437			22,677
Inventories		39,096			38,152
Total current assets		1,095,268			1,034,409
LONG-TERM ASSETS:
Property and equipment, net		73,251			51,479
Field equipment, net		12,913			11,384
Right-of-use assets		28,330			34,835
Other long-term assets		12,224			14,022
Total long-term assets		126,718			111,720
TOTAL ASSETS		1,221,986			1,146,129

Consolidated Balance Sheets USD in thousands (except share data)
	September 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:
Convertible note		557,333
Trade payables		91,319				94,391
Other payables, lease liabilities and accrued expenses		86,350				84,724
Total current liabilities		735,002				179,115
LONG-TERM LIABILITIES:
Convertible note						568,822
Senior secured credit facility, net		97,149
Long-term leases		21,144				27,420
Employee benefit liabilities		7,892				8,258
Other long-term liabilities		18				18
Total long-term liabilities		126,203				604,518
TOTAL LIABILITIES		861,205				783,633
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Share capital
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 108,100,392 shares and 107,075,754 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively
Additional paid-in capital		1,454,367				1,353,468
Accumulated other comprehensive income (loss)		(5,378				(5,469
Retained earnings (accumulated deficit)		(1,088,208				(985,503
TOTAL SHAREHOLDERS' EQUITY		360,781				362,496
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY		1,221,986				1,146,129

Non-U.S. GAAP financial measures reconciliation USD in thousands
	Three months ended September 30,											Nine months ended September 30,
	2024				2023				% Change			2024				2023				% Change
Net income (loss)		(30,570				(49,485			(38				(102,705				(159,964			(36
Add: Income tax		8,985				1,263			611				26,749				6,758			296
Add: Financial expenses (income), net		(10,507				(10,023			5				(31,236				(27,948			12
Add: Depreciation and amortization		2,458				2,803			(12				8,131				8,246			(1
EBITDA		(29,634				(55,442			(47				(99,061				(172,908			(43
Add: Share-based compensation		31,364				26,346			19				97,278				98,170			(1
Adjusted EBITDA		1,730				(29,096			(106				(1,783				(74,738			(98

View source version on businesswire.com: https://www.businesswire.com/news/home/20241030502767/en/

Contacts:

Investors:
Ingrid Goldberg
[e-mail]

Media:
Catherine Falcetti
[e-mail]