Full year 2024 net revenues of $605 million and fourth quarter net revenues of $161 million
Optune Lua® received FDA approval for the treatment of metastatic non-small cell lung cancer, commercial rollout underway in the U.S.
Phase 3 PANOVA-3 trial met primary endpoint, demonstrating statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer
BAAR, Switzerland, February 27, 2025--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today reported financial results for the quarter and full year ended December 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).
"Entering 2024, our team was focused on three objectives – grow our core business treating glioblastoma, launch in non-small cell lung cancer, and deliver on the promise of our clinical pipeline. I am proud to say we have successfully achieved all three goals," said Ashley Cordova, CEO Novocure. "2025 is a defining year for Novocure as we enter a new era with a multi-indication platform propelled by positive Phase 3 data in three indications – one FDA-approved and two advancing toward regulatory submission. We believe we are positioned to transform patient outcomes across multiple high-need oncology indications."
Financial updates for the fourth quarter and full year ended December 31, 2024:
Operational updates for the fourth quarter ended December 31, 2024:
Fourth quarter and recent updates and achievements:
Anticipated clinical milestones:
Fourth quarter and full year 2024 financial results conference call:
Novocure will host a conference call and webcast to discuss fourth quarter and full year 2024 financial results at 8:00 a.m. EST today, Thursday, February 27, 2025. 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 and 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 Baar, 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 X(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 study 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 27, 2025, and subsequent flings 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 |
Twelve months ended |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Net revenues |
$ |
161,266 |
$ |
133,784 |
$ |
605,220 |
$ |
509,338 |
||||||||
Cost of revenues |
33,466 |
32,556 |
137,181 |
128,280 |
||||||||||||
Gross profit |
127,800 |
101,228 |
468,039 |
381,058 |
||||||||||||
Operating costs and expenses: |
||||||||||||||||
Research, development and clinical studies |
51,210 |
54,308 |
209,645 |
223,062 |
||||||||||||
Sales and marketing |
67,411 |
59,188 |
239,063 |
226,809 |
||||||||||||
General and administrative |
72,483 |
39,448 |
189,827 |
164,057 |
||||||||||||
Total operating costs and expenses |
191,104 |
152,944 |
638,535 |
613,928 |
||||||||||||
Operating income (loss) |
(63,304 |
) |
(51,716 |
) |
(170,496 |
) |
(232,870 |
) |
||||||||
Financial (expenses) income, net |
8,098 |
13,182 |
39,334 |
41,130 |
||||||||||||
Income (loss) before income tax |
(55,206 |
) |
(38,534 |
) |
(131,162 |
) |
(191,740 |
) |
||||||||
Income tax |
10,716 |
8,545 |
37,465 |
15,303 |
||||||||||||
Net income (loss) |
$ |
(65,922 |
) |
$ |
(47,079 |
) |
$ |
(168,627 |
) |
$ |
(207,043 |
) |
||||
Basic and diluted net income (loss) per ordinary share |
$ |
(0.61 |
) |
$ |
(0.45 |
) |
$ |
(1.56 |
) |
$ |
(1.95 |
) |
||||
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share |
108,474,919 |
106,983,693 |
107,834,368 |
106,391,178 |
Consolidated Balance Sheets |
||||||
USD in thousands (except share data) |
||||||
December 31, |
||||||
2024 |
2023 |
|||||
Assets |
||||||
Current assets: |
||||||
Cash and cash equivalents |
$ |
163,767 |
$ |
240,821 |
||
Short-term investments |
796,106 |
669,795 |
||||
Restricted cash |
2,327 |
1,743 |
||||
Trade receivables, net |
74,226 |
61,221 |
||||
Receivables and prepaid expenses |
35,063 |
22,677 |
||||
Inventories |
35,086 |
38,152 |
||||
Total current assets |
1,106,575 |
1,034,409 |
||||
Long-term assets: |
||||||
Property and equipment, net |
77,660 |
51,479 |
||||
Field equipment, net |
14,811 |
11,384 |
||||
Right-of-use assets |
27,120 |
34,835 |
||||
Other long-term assets |
14,618 |
14,022 |
||||
Total long-term assets |
134,209 |
111,720 |
||||
Total assets |
$ |
1,240,784 |
$ |
1,146,129 |
Consolidated Balance Sheets |
||||||||
USD in thousands (except share data) |
||||||||
December 31, |
||||||||
2024 |
2023 |
|||||||
Liabilities and shareholders’ equity |
||||||||
Current liabilities: |
||||||||
Convertible note |
$ |
558,160 |
$ |
— |
||||
Trade payables |
$ |
105,086 |
$ |
94,391 |
||||
Other payables, lease liabilities and accrued expenses |
93,130 |
84,724 |
||||||
Total current liabilities |
756,376 |
179,115 |
||||||
Long-term liabilities: |
||||||||
Convertible note |
— |
568,822 |
||||||
Senior secured credit facility, net |
97,300 |
— |
||||||
Deferred revenues |
— |
— |
||||||
Long term leases |
19,971 |
27,420 |
||||||
Employee benefit liabilities |
6,940 |
8,258 |
||||||
Other long-term liabilities |
18 |
18 |
||||||
Total long-term liabilities |
124,229 |
604,518 |
||||||
Total liabilities |
880,605 |
783,633 |
||||||
Commitments and contingencies |
||||||||
Shareholders’ equity: |
||||||||
Share capital - |
||||||||
Ordinary shares - No par value, Unlimited shares authorized; Issued and outstanding: 108,516,819 shares and 107,075,754 shares at December 31, 2024 and December 31, 2023 respectively; |
— |
— |
||||||
Additional paid-in capital |
1,519,809 |
1,353,468 |
||||||
Accumulated other comprehensive income (loss) |
(5,500 |
) |
(5,469 |
) |
||||
Retained earnings (accumulated deficit) |
(1,154,130 |
) |
(985,503 |
) |
||||
Total shareholders’ equity |
360,179 |
362,496 |
||||||
Total liabilities and shareholders’ equity |
$ |
1,240,784 |
$ |
1,146,129 |
Non-U.S. GAAP financial measures reconciliation |
||||||||||||||||||||||
USD in thousands |
||||||||||||||||||||||
Three months ended December 31, |
Twelve months ended December 31, |
|||||||||||||||||||||
2023 |
2022 |
% Change |
2023 |
2022 |
% Change |
|||||||||||||||||
Net income (loss) |
$ |
(65,922 |
) |
$ |
(47,079 |
) |
40 |
% |
$ |
(168,627 |
) |
$ |
(207,043 |
) |
(19 |
)% |
||||||
Add: Income tax |
10,716 |
8,545 |
25 |
% |
$ |
37,465 |
$ |
15,303 |
145 |
% |
||||||||||||
Add: Financial expenses (income), net |
(8,098 |
) |
(13,182 |
) |
(39 |
)% |
$ |
(39,334 |
) |
$ |
(41,130 |
) |
(4 |
)% |
||||||||
Add: Depreciation and amortization |
3,104 |
2,723 |
14 |
% |
$ |
11,235 |
$ |
10,969 |
2 |
% |
||||||||||||
EBITDA |
$ |
(60,200 |
) |
$ |
(48,993 |
) |
23 |
% |
$ |
(159,261 |
) |
$ |
(221,901 |
) |
(28 |
)% |
||||||
Add: Share-based compensation |
62,757 |
17,438 |
260 |
% |
$ |
160,035 |
$ |
115,608 |
38 |
% |
||||||||||||
Adjusted EBITDA |
$ |
2,557 |
$ |
(31,555 |
) |
(108 |
)% |
$ |
774 |
$ |
(106,293 |
) |
(101 |
)% |
Active Patients |
||||||||||||
December 31, |
||||||||||||
2024 |
2023 |
|||||||||||
CNS |
Lung |
Total |
CNS |
Lung |
Total |
|||||||
Active patients at period end* |
||||||||||||
United States |
2,161 |
31 |
2,192 |
2,145 |
17 |
2,162 |
||||||
International markets: |
||||||||||||
Germany |
564 |
11 |
575 |
520 |
5 |
525 |
||||||
France |
426 |
— |
426 |
262 |
— |
262 |
||||||
Japan |
420 |
— |
420 |
375 |
— |
375 |
||||||
Other international |
506 |
7 |
513 |
431 |
— |
431 |
||||||
International markets - Total |
1,916 |
18 |
1,934 |
1,588 |
5 |
1,593 |
||||||
4,077 |
49 |
4,126 |
3,733 |
22 |
3,755 |
*Lung includes both active patients in non-small cell lung cancer and malignant pleural mesothelioma (MPM). Worldwide, there were 29 and 22 active MPM patients on therapy as of December 31, 2024 and 2023, respectively.
Important Safety Information
What is Optune Gio ® approved to treat?
Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.
Newly diagnosed GBM
If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if:
Recurrent GBM
If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:
Who should not use Optune Gio?
Optune Gio is not for everyone. Talk to your doctor if you have:
Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.
What should I know before using Optune Gio?
Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Gio.
What are the possible side effects of Optune Gio?
Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.
Please visit OptuneGio.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
Important Safety Information
What is Optune Lua ® approved to treat?
Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.
Who should not use Optune Lua?
Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have:
What should I know before using Optune Lua?
Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua.
What are the possible side effects of Optune Lua?
The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing).
Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions.
Please visit OptuneLua.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250227102270/en/
Contacts
INVESTORS:
Ingrid Goldberg
investorinfo@novocure.com
MEDIA:
Catherine Falcetti
media@novocure.com
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