On February 27, 2025 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2024 (Press release, NovoCure, FEB 27, 2025, View Source [SID1234650731]). 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).
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"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 $605.2 million, an increase of 19% year-over-year, primarily driven by continued launch success in France for Optune Gio for glioblastoma (GBM) and improved approval rates in the U.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 $161.3 million, an increase of 21% year-over-year.
The U.S., Germany, France and Japan contributed $107.2 million, $17.4 million, $15.7 million and $8.5 million in quarterly net revenues, respectively, with our other active markets contributing $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 $8.3 million 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 $14.0 million of increased revenue from prior period claims disclosed through the third quarter.
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 the U.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 $51.2 million, a decrease of 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 $67.4 million, an increase of 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 $72.5 million, an increase of 84% from the same period in 2023. This was primarily driven by $36.1 million in one-time stock-based compensation expenses related to U.S. Food and Drug Administration (FDA) approval of our metastatic NSCLC indication.
Net loss for the quarter was $65.9 million with loss per share of $0.61.
Adjusted EBITDA* for the quarter was $2.6 million, an increase of $34.1 million from the same period in 2023. This increase was primarily driven by revenue growth and operational efficiencies.
Cash, cash equivalents, and short-term investments were $959.9 million as of December 31, 2024.
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 and Japan 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 and Japan 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.