Novocure Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Company Update
Novocure (NVCR) reported strong financial results for Q4 and full year 2024, with total net revenues reaching $605.2 million for the year, up 19% year-over-year. Q4 revenues were $161.3 million, showing a 21% increase.
Key developments include FDA approval of Optune Lua for metastatic non-small cell lung cancer treatment and positive Phase 3 PANOVA-3 trial results for pancreatic cancer. The company maintained 4,126 active patients globally, with 4,077 using Optune Gio for glioblastoma treatment.
Regional Q4 revenues: US ($107.2M), Germany ($17.4M), France ($15.7M), and Japan ($8.5M). Gross margin was 79%. The company reported a quarterly net loss of $65.9 million ($0.61 per share) with adjusted EBITDA of $2.6 million.
Novocure (NVCR) ha riportato risultati finanziari solidi per il quarto trimestre e l'intero anno 2024, con ricavi netti totali che hanno raggiunto $605,2 milioni per l'anno, in aumento del 19% rispetto all'anno precedente. I ricavi del quarto trimestre sono stati di $161,3 milioni, mostrando un incremento del 21%.
Sviluppi chiave includono l'approvazione della FDA per Optune Lua per il trattamento del cancro polmonare non a piccole cellule metastatico e risultati positivi della fase 3 dello studio PANOVA-3 per il cancro pancreatico. L'azienda ha mantenuto 4.126 pazienti attivi a livello globale, con 4.077 che utilizzano Optune Gio per il trattamento del glioblastoma.
Ricavi regionali del quarto trimestre: Stati Uniti ($107,2 milioni), Germania ($17,4 milioni), Francia ($15,7 milioni) e Giappone ($8,5 milioni). Il margine lordo era del 79%. L'azienda ha registrato una perdita netta trimestrale di $65,9 milioni ($0,61 per azione) con un EBITDA rettificato di $2,6 milioni.
Novocure (NVCR) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con ingresos netos totales que alcanzaron $605.2 millones para el año, un aumento del 19% en comparación con el año anterior. Los ingresos del cuarto trimestre fueron de $161.3 millones, mostrando un incremento del 21%.
Los desarrollos clave incluyen la aprobación de la FDA de Optune Lua para el tratamiento del cáncer de pulmón no microcítico metastásico y resultados positivos del ensayo de fase 3 PANOVA-3 para el cáncer de páncreas. La compañía mantuvo 4,126 pacientes activos a nivel mundial, con 4,077 utilizando Optune Gio para el tratamiento del glioblastoma.
Ingresos regionales del cuarto trimestre: EE. UU. ($107.2 millones), Alemania ($17.4 millones), Francia ($15.7 millones) y Japón ($8.5 millones). El margen bruto fue del 79%. La compañía reportó una pérdida neta trimestral de $65.9 millones ($0.61 por acción) con un EBITDA ajustado de $2.6 millones.
Novocure (NVCR)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했으며, 연간 총 순수익이 $605.2 백만에 달해 전년 대비 19% 증가했습니다. 4분기 수익은 $161.3 백만으로 21% 증가했습니다.
주요 개발 사항으로는 전이성 비소세포 폐암 치료를 위한 Optune Lua의 FDA 승인과 췌장암에 대한 3상 PANOVA-3 시험 결과가 긍정적이라는 점이 있습니다. 회사는 전 세계적으로 4,126명의 활성 환자를 유지하고 있으며, 그 중 4,077명이 신경교종 치료를 위해 Optune Gio를 사용하고 있습니다.
4분기 지역별 수익: 미국 ($107.2M), 독일 ($17.4M), 프랑스 ($15.7M), 일본 ($8.5M). 총 마진은 79%였습니다. 회사는 분기 순손실이 $65.9 백만 ($0.61 per share)이며 조정된 EBITDA는 $2.6 백만이라고 보고했습니다.
Novocure (NVCR) a rapporté de solides résultats financiers pour le quatrième trimestre et l'année complète 2024, avec des revenus nets totaux atteignant $605,2 millions pour l'année, en hausse de 19 % par rapport à l'année précédente. Les revenus du quatrième trimestre s'élevaient à $161,3 millions, affichant une augmentation de 21 %.
Les développements clés incluent l'approbation de la FDA pour Optune Lua pour le traitement du cancer du poumon non à petites cellules métastatique et des résultats positifs de l'essai de phase 3 PANOVA-3 pour le cancer du pancréas. L'entreprise a maintenu 4 126 patients actifs dans le monde, dont 4 077 utilisant Optune Gio pour le traitement du glioblastome.
Revenus régionaux du quatrième trimestre : États-Unis ($107,2 millions), Allemagne ($17,4 millions), France ($15,7 millions) et Japon ($8,5 millions). La marge brute était de 79 %. L'entreprise a rapporté une perte nette trimestrielle de $65,9 millions ($0,61 par action) avec un EBITDA ajusté de $2,6 millions.
Novocure (NVCR) berichtete über starke Finanzergebnisse für das vierte Quartal und das gesamte Jahr 2024, mit einem Gesamtumsatz von $605,2 Millionen für das Jahr, was einem Anstieg von 19 % im Vergleich zum Vorjahr entspricht. Die Umsätze im vierten Quartal betrugen $161,3 Millionen, was einem Anstieg von 21 % entspricht.
Wichtige Entwicklungen umfassen die FDA-Zulassung von Optune Lua zur Behandlung von metastasiertem nicht-kleinzelligem Lungenkrebs und positive Ergebnisse der Phase-3-Studie PANOVA-3 für Bauchspeicheldrüsenkrebs. Das Unternehmen hatte weltweit 4.126 aktive Patienten, von denen 4.077 Optune Gio zur Behandlung von Glioblastomen verwendeten.
Regionale Umsätze im vierten Quartal: USA ($107,2 Millionen), Deutschland ($17,4 Millionen), Frankreich ($15,7 Millionen) und Japan ($8,5 Millionen). Die Bruttomarge betrug 79 %. Das Unternehmen berichtete über einen quartalsweisen Nettoverlust von $65,9 Millionen ($0,61 pro Aktie) mit einem bereinigten EBITDA von $2,6 Millionen.
- Revenue growth: 19% YoY increase to $605.2M annual revenue
- FDA approval for Optune Lua in metastatic NSCLC
- Positive Phase 3 PANOVA-3 trial results in pancreatic cancer
- Strong gross margin of 79%
- Healthy cash position of $959.9M
- Q4 net loss of $65.9M ($0.61 per share)
- Expected low mid-single digit growth rate for 2025
- 84% increase in G&A expenses
- One-time stock compensation expense of $36.1M impacting profits
Insights
Novocure's Q4 and full-year 2024 results reveal a company in strategic transition from a single-indication therapy to a multi-indication oncology platform. The 19% year-over-year revenue growth to
The
The FDA approval of Optune Lua for metastatic non-small cell lung cancer represents a transformative expansion opportunity. With 52 NSCLC prescriptions already received between October approval and year-end, early adoption signals are encouraging for this substantially larger addressable market compared to GBM. This approval triggered
Most promising is the positive Phase 3 PANOVA-3 trial in pancreatic cancer, which could potentially open a third major revenue stream. Breakthrough Device designations for both pancreatic cancer and brain metastases from NSCLC should accelerate the regulatory pathway for these indications.
The
Investors should note the planned reporting change from prescriptions to active patients by indication starting Q1 2026, which better aligns with the recurring revenue business model and provides greater visibility into the adoption curve across multiple indications.
Novocure's 2024 results mark a pivotal expansion of TTFields therapy beyond its original glioblastoma indication, establishing it as a multi-indication platform with significant clinical validation. The FDA approval of Optune Lua for metastatic NSCLC represents entry into a market nearly 10 times larger than GBM, with approximately 190,000 new NSCLC cases annually in the U.S. alone.
The approval specifically positions TTFields as a concurrent therapy with either immunotherapy (PD-1/PD-L1 inhibitors) or chemotherapy (docetaxel) in the second-line setting. This strategic positioning leverages TTFields' key advantage: localized anti-mitotic effects without adding systemic toxicity, making it an ideal combination partner with established therapies.
The 52 NSCLC prescriptions received in just over two months post-approval represents an encouraging adoption rate, particularly considering the education required for this novel treatment modality. Early patient conversion (20 active patients by year-end) suggests efficient onboarding processes are in place.
The positive Phase 3 PANOVA-3 results in locally advanced pancreatic cancer could be truly transformative. Pancreatic cancer has seen minimal therapeutic advances in decades, with most patients surviving less than one year after diagnosis. Any statistically significant survival improvement in this disease represents a meaningful clinical advancement.
The FDA's Breakthrough Device designations for both pancreatic cancer and brain metastases from NSCLC will accelerate regulatory review, potentially shortening approval timelines by 6-12 months. These designations are granted only when preliminary evidence indicates potential for substantial improvement over existing therapies for life-threatening conditions.
The approval of the Head Flexible Electrode arrays in both U.S. and Japan addresses a critical barrier to TTFields therapy – patient comfort and adherence. The original rigid arrays could cause skin irritation and discomfort, potentially reducing the recommended 18+ hours daily usage. Improved form factors should enhance compliance, which directly correlates with efficacy.
Looking ahead, the PANOVA-4 trial in metastatic pancreatic cancer and TRIDENT trial in newly diagnosed GBM could further expand TTFields' applications, potentially establishing it as a foundational component of cancer care across multiple aggressive tumor types.
Full year 2024 net revenues of
Optune Lua® received FDA approval for the treatment of metastatic non-small cell lung cancer, commercial rollout underway in the
Phase 3 PANOVA-3 trial met primary endpoint, demonstrating statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer
BAAR,
“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:
-
Total net revenues for the year were
, an increase of$605.2 million 19% year-over-year, primarily driven by continued launch success inFrance for Optune Gio® for glioblastoma (GBM) and improved approval rates in theU.S. , which are now reflected in our revenue baseline. 2025 net revenue growth is expected to reflect growth in Optune Gio active patients. As the GBM business reaches maturity we expect to continue to grow at a low mid-single digit rate this year. -
Total net revenues for the quarter were
, an increase of$161.3 million 21% year-over-year.-
The
U.S. ,Germany ,France andJapan contributed ,$107.2 million ,$17.4 million and$15.7 million in quarterly net revenues, respectively, with our other active markets contributing$8.5 million .$10.4 million -
Revenue in
Greater China from Novocure’s partnership with Zai Lab totaled .$2.0 million -
Improved approval rates in the
U.S. resulted in of increased net revenue from prior period claims during the quarter, which we believe should not be considered in our 2025 baseline. This is in addition to the$8.3 million of increased revenue from prior period claims disclosed through the third quarter.$14.0 million
-
The
-
Gross margin for the quarter was
79% . In 2025, we expect our gross margins will be impacted by current and future product enhancements, such as theU.S. launch of our Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio, and the launch of Optune Lua in metastatic non-small cell lung cancer (NSCLC). Our current analysis of the global tariff environment leads us to believe there should not be a material impact to margins in the short term and we are actively working to mitigate any potential impacts in the medium-to-long term. -
Research, development and clinical studies expenses for the quarter were
, a decrease of$51.2 million 6% from the same period in 2023. Clinical trial expenses can fluctuate quarter-to-quarter depending on the number of clinical trials actively underway, amount of clinical research organization services delivered and clinical materials procured. -
Sales and marketing expenses for the quarter were
, an increase of$67.4 million 14% from the same period in 2023. This primarily reflects the expansion of our NSCLC sales force as we launch in this new indication. -
General and administrative expenses for the quarter were
, an increase of$72.5 million 84% from the same period in 2023. This was primarily driven by in one-time stock-based compensation expenses related to$36.1 million U.S. Food and Drug Administration (FDA) approval of our metastatic NSCLC indication. -
Net loss for the quarter was
with loss per share of$65.9 million .$0.61 -
Adjusted EBITDA* for the quarter was
, an increase of$2.6 million from the same period in 2023. This increase was primarily driven by revenue growth and operational efficiencies.$34.1 million -
Cash, cash equivalents, and short-term investments were
as of December 31, 2024.$959.9 million
Operational updates for the fourth quarter ended December 31, 2024:
- As of December 31, 2024, there were 4,126 total active patients on TTFields therapy globally.
-
1,520 Optune Gio prescriptions for the treatment of GBM were received in the quarter, consistent with the same period in 2023. The
U.S. ,Germany ,France andJapan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions contributed by other active markets. -
As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. The
U.S. ,Germany ,France andJapan contributed 2,161; 564; 426 and 420 Optune Gio active patients, respectively, with the remaining 506 active patients contributed by other active markets. -
On October 15, 2024, Optune Lua was approved by the
U.S. FDA for the treatment of metastatic NSCLC concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. Between approval and year end, 52 Optune Lua prescriptions were received for metastatic NSCLC. - As of December 31, 2024, there were 20 active metastatic NSCLC patients on Optune Lua and 29 active malignant pleural mesothelioma (MPM) patients on Optune Lua.
- Beginning in Q1 2026, Novocure intends to stop reporting new prescriptions received in period and will provide active patients on TTFields therapy by indication and by material market as the key operating statistics.
Fourth quarter and recent updates and achievements:
- In October 2024, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of brain metastases from NSCLC. Breakthrough Device designation provides more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of marketing applications upon filing, and expedited review of pre-Premarket Approval Application (PMA) manufacturing and quality systems compliance inspections.
- In October 2024, the FDA approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
- In December 2024, the company announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer. Novocure plans to submit the full data for presentation at an upcoming medical congress.
- In December 2024, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of unresectable, locally advanced pancreatic cancer.
- In January 2025, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved Novocure’s HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
Anticipated clinical milestones:
- Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
- Data from Phase 3 TRIDENT clinical trial in newly diagnosed GBM (2026)
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,
*Non-GAAP Financial Measurements
We measure our performance based upon a non-
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
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- |
||||||||||||||||||||||
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* |
|
|
|
|
|
|
||||||
|
2,161 |
31 |
2,192 |
2,145 |
17 |
2,162 |
||||||
International markets: |
|
|
|
|
|
|
||||||
|
564 |
11 |
575 |
520 |
5 |
525 |
||||||
|
426 |
— |
426 |
262 |
— |
262 |
||||||
|
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:
- Your cancer is confirmed by your healthcare professional AND
- You have had surgery to remove as much of the tumor as possible
Recurrent GBM
If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:
- You have tried surgery and radiation and they did not work or are no longer working AND
- You have tried chemotherapy and your GBM has been confirmed by your healthcare professional
Who should not use Optune Gio?
Optune Gio is not for everyone. Talk to your doctor if you have:
- An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
- A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
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.
- Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment
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:
- An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly
- A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing
- Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.
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.
- Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected
- If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment.
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/
INVESTORS:
Ingrid Goldberg
investorinfo@novocure.com
MEDIA:
Catherine Falcetti
media@novocure.com
Source: Novocure
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