On October 30, 2024 Novocure (NASDAQ: NVCR) 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) (Press release, NovoCure, OCT 30, 2024, View Source [SID1234647561]).
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"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.