Novocure Reports Slight 3Q23 Revenue Miss; Focus on Regulatory Submissions Following Successful LUNAR Trial
10/27/23 (written by: Scott Gleason) Novocure has reported its financial results for the third quarter ending on September 30, 2023 with total net revenues for the quarter amounted to $127.3 million, reflecting a 3% decrease from the same period in 2022. The decline was primarily due to reduced collections from denied or appealed claims in the U.S. The street had forecasted total revenue of $128.7 million.
During the quarter, 1,467 prescriptions were received, marking a 6% increase compared to the same period in 2022. As of September 30, 2023, there were 3,639 active patients on TTFields therapy. Management noted a recent positive launch in France with 150 patients on therapy and a decline in revenue in Germany as the commercial team focused on cases more likely to be reimbursed.
The largest focus of investors however is on the recent LUNAR trial and pending regulatory submissions for NSCLC, as well as upcoming data events in 2024. In August, the company reported Phase 3 LUNAR clinical trial results, focusing on metastatic non-small cell lung cancer treatment, and the results were published in Lancet Oncology. These findings demonstrated a significant and meaningful extension of overall survival with TTFields therapy alongside standard care, boasting a median overall survival of 13.2 months compared to 9.9 months with standard care alone. Notably, patients receiving TTFields therapy in combination with an immune checkpoint inhibitor exhibited even more substantial benefits, with a median overall survival of 18.5 months compared to 10.8 months for patients on the immune checkpoint inhibitor alone. The company will submit its final module to the FDA for this large indication and has already submitted for CE Mark.
Novocure also noted two significant Phase 3 trials nearing key milestones. The METIS trial, expected to reveal top-line results in late Q1 2024, is investigating the use of TTFields therapy in conjunction with stereotactic radiosurgery to treat brain metastases. Meanwhile, the PANOVA-3 trial, poised to release top-line data in the latter half of 2024, explores the effectiveness of TTFields therapy when combined with nab-paclitaxel and gemcitabine for first-line treatment of locally advanced pancreatic cancer. Novocure’s PANOVA-4 study is making headway, focusing on TTFields therapy with atezolizumab for metastatic pancreatic cancer treatment.
The company also noted that its INNOVATE-3 trial, which studied platinum-resistant ovarian cancer did not meet its primary endpoint.
Adjusted EBITDA in the quarter was ($29.1) million compared to $4.3 million last year as the company ramped up its sales and marketing expenses to support broader geographic launches. Diluted EPS were ($0.46) vs. ($0.25) last year. Analysts were forecasting EPS of ($0.52). The company ended the quarter with $921 mil. in cash and cash equivalents on hand.