
NovoCure (NVCR) Q3 2024 Earnings Call Transcript | The Motley Fool
Image source: The Motley Fool. Date Wednesday, Oct. 30, 2024 at 8:00 a.m. ET Call participants Executive Chairman - Bill Doyle Chief Executive Officer - Asaf Danziger Chief Financial Officer - Ashley Cordova Chief Operating Officer - Mukund Paravasthu President - Frank Leonard Chief Medical Officer - Nicolas Leupin Takeaways Net revenue -- $155 million, representing 22% growth year over year, attributed primarily to active patient expansion and improved U.S. approval rates. Active patients on therapy -- 4,113 global patients, a company record and an increase of 13% year-over-year. Gross margin -- 77%, up from 75% in the prior year period, supported by higher net revenue per patient and strong French market contribution. SG&A expense -- $100 million, flat with the third quarter of 2023, with higher sales and marketing costs offset by lower personnel and general and administrative expense. Research and development expense -- $52 million, down 3% from the previous year’s quarter. Adjusted EBITDA -- $2 million, improving by $31 million year over year and positive for the second consecutive quarter. Net loss -- $31 million, translating to a loss per share of $0.28. U.S. approval rates -- Boosted Q3 net revenues by $5 million from prior period billing, now considered part of the baseline going forward. FDA approval for Optune Lua -- Cleared as a therapy for post-platinum metastatic non-small cell lung cancer in combination with immune checkpoint inhibitor or docetaxel. First commercial lung prescription -- Received shortly after approval, following expedited physician certification and salesforce mobilization. Europe and Japan regulatory status -- Applications submitted and launch preparations ongoing; MDR is extending timelines in Europe, while Japanese PMDA review is progressing with no specified timeline. Breakthrough device designation -- Granted by FDA for tumor treating fields therapy in brain metastases from non-small cell lung cancer. PANOVA-3 (Phase 3) clinical trial -- Top-line data expected later this year after patient follow-up completion on pancreatic cancer; timelines for approval filing estimated at one to two quarters for submission plus nine to twelve months for review. PANOVA-4 (Phase 2) clinical trial -- Enrollment completed for metastatic pancreatic cancer, adding atezolizumab to the existing combination. METIS trial results -- Median time to intracranial progression was 21.9 months with tumor treating fields, compared to 11.3 months for control, with maintenance of quality of life and cognitive function. LUNAR-2 and LUNAR-4 -- Both lung cancer trials open and actively recruiting; LUNAR-2 targets first-line, LUNAR-4 targets second-line patients. Trident and KEYNOTE D58 (GBM trials) -- Trident completed enrollment and is in follow-up; KEYNOTE D58 site initiation underway. Leadership transitions -- CEO Asaf Danziger to retire at year-end, replaced by Ashley Cordova; Christoph Brackmann to assume CFO role January 1; Mukund Paravasthu newly appointed COO. Expected lung cancer treatment duration -- CFO Cordova said, “four to five months is what I would model,” consistent with clinical trial experience. Lung indication gross margin impact -- Launch of Next Generation Arrays as a lung cancer indication expected to be a headwind, but anticipated to normalize within six...
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