On April 24, 2025 Novocure (NASDAQ: NVCR) reported financial results for the first quarter ended March 31, 2025. 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) (Press release, NovoCure, APR 24, 2025, View Source [SID1234652121]).
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"This is a period of meaningful momentum for Novocure," said Ashley Cordova, CEO Novocure. "After years in a single commercial indication, our footprint is expanding across new indications, new centers, and new physician specialties. Our lung launch is progressing. Our pipeline is advancing. And our commitment to patient-forward innovation is stronger than ever. We look forward to updating you on our progress as the year unfolds."
Financial updates for the first quarter ended March 31, 2025:
Total net revenues for the quarter were $155.0 million, an increase of 12% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets and to a lesser extent from reimbursement improvements.
The U.S., Germany, France and Japan contributed $93.2 million, $18.7 million, $17.9 million and $8.7 million, respectively, with other active markets contributing $11.9 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the quarter was $1.5 million, including $0.8 million from malignant pleural mesothelioma (MPM), and $0.7 million from metastatic non-small cell lung cancer (NSCLC).
Gross margin for the quarter was 75% compared to 76% in the prior year period.
The reduction of gross margin was primarily driven by the roll out of our HFE arrays and the NSCLC launch, where we are treating on-label patients at risk prior to establishing broad reimbursement.
The global tariff environment is changing rapidly. On April 9, 2025 the U.S. temporarily delayed implementation of new tariffs by 90 days, resulting in a 10% tariff for most countries. If the current pause is extended through year-end, Novocure could see an increase in import duties of up to $8 million in 2025. If the tariffs return to pre-April 9 rates after the current 90-day pause, Novocure could see an increase in import duties of up to $11 million in 2025. Novocure is closely monitoring the evolving tariff landscape with the intent to mitigate impacts on our supply chain costs where possible.
Research, development and clinical studies expenses for the quarter were $53.8 million, an increase of 4% from the same period in 2024.
Sales and marketing expenses for the quarter were $55.8 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force.
General and administrative expenses for the quarter were $44.8 million, an increase of 13% compared to the same period in 2024. This was primarily driven by a $2.3 million one-time expense to retire a production line related to supply chain optimization efforts and higher personnel costs associated with our launch of NSCLC and preparations for additional future indication launches
Net loss for the quarter was $34.3 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $(5.0) million.
Cash, cash equivalents and short-term investments were $929.1 million as of March 31, 2025.
Operational updates for the first quarter ended March 31, 2025:
As of March 31, 2025, there were 4,268 total active patients on TTFields therapy globally.
Optune Gio
1,608 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 908; 198; 207 and 118 prescriptions, respectively, with the remaining 177 prescriptions contributed by other active markets.
As of March 31, 2025, there were 4,162 active Optune Gio patients on therapy, an increase of 9% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,157; 573; 463 and 445 Optune Gio active patients, respectively, with the remaining 524 active patients contributed by other active markets.
Optune Lua
127 total prescriptions for Optune Lua were received in the quarter. 92 Optune Lua prescriptions were received for the treatment of metastatic NSCLC and 35 prescriptions were received for the treatment of malignant pleural mesothelioma (MPM).
As of March 31, 2025, there were 106 active Optune Lua patients on therapy, including 62 patients treated for metastatic NSCLC patients and 44 patients treated for MPM.
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.
Quarterly updates and achievements:
In 2024, Novocure announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in overall survival. The results of the Phase 3 PANOVA-3 clinical trial will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) scientific congress. Novocure plans to host an investor event with live webcast featuring the trial principal investigator and Novocure leadership following the presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
In April, Novocure received CE Mark for the use of Optune Lua concurrently with immune checkpoint inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen.
Anticipated clinical milestones:
Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (H1 2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (H1 2026)
Conference call details
Novocure will host a conference call and webcast to discuss first quarter 2025 financial results at 8:00 a.m. EDT today, Wednesday, April 24, 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, 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.