NovoCure (NASDAQ:NVCR) outlined its strategy for returning its glioblastoma franchise to growth, expanding launches in pancreatic and lung cancer, and moving toward profitability during the Morgan Stanley Healthcare Conference.
Chief Executive Officer Frank Leonard said the company, founded more than 25 years ago in Israel, has developed Tumor Treating Fields, a technology that uses electric fields to disrupt cancer cell division. The company has invested roughly $1 billion in research and development and has advanced the technology through multiple Phase III programs, Leonard said. He described the treatment approach as having low toxicity and no systemic toxicity, with skin irritation as the primary adverse event.
Glioblastoma Growth and Clinical Development
NovoCure’s Optune Gio device, approved in the U.S. for newly diagnosed glioblastoma since 2015, recorded 8% year-over-year volume growth through the first two quarters of the year, according to Leonard. The franchise had reached peak market penetration around early 2021 before moderating in subsequent years.
Leonard attributed the return to growth to improved patient identification, segmentation and targeting tools, as well as a larger commercial organization. As NovoCure launched products in pancreatic and lung cancer, it effectively doubled its sales force, allowing the company to retain coverage of high-volume glioblastoma practices while expanding into community practices that may see only one or two glioblastoma patients annually.
The company estimates that U.S. penetration stands at approximately 35% to 40% of eligible glioblastoma patients. Leonard said NovoCure remains committed to growing the franchise at a single-digit rate on an absolute basis, though year-over-year comparisons may become more difficult toward year-end.
NovoCure also expects to complete enrollment by the end of the year in its Phase III KEYNOTE D58 glioblastoma trial. The study is evaluating Tumor Treating Fields and pembrolizumab in addition to the established Stupp protocol. Leonard said the event-driven trial could read out in roughly two years.
He said the company is seeking both further survival gains and validation of the theory that Tumor Treating Fields can alter the tumor microenvironment and improve responses to immune checkpoint inhibitors, which have historically failed in brain neoplasms and glioblastoma.
Pancreatic Cancer and Combination Strategy
Leonard said NovoCure’s pancreatic cancer program targets patients with locally advanced, unresectable Stage III disease receiving first-line treatment, distinguishing it from RASONQUE, which he said was recently approved for previously treated metastatic pancreatic cancer.
He said the populations have differing clinical needs, with metastatic second-line patients often requiring urgent treatment, while locally advanced patients may begin treatment with the goal of reaching surgery. NovoCure’s data in locally advanced pancreatic cancer showed enhanced local disease control, delayed progression to the liver and extended pain-free survival, Leonard said.
The company is also exploring combinations of Tumor Treating Fields with KRAS inhibitors. Leonard said preclinical research, subsequently validated by the Mayo Clinic, showed promising signals for combining the technology with KRAS inhibition. NovoCure has announced plans to open a clinical trial of Tumor Treating Fields with daraxonrasib in its approved second-line metastatic indication to evaluate safety and feasibility.
Chief Financial Officer Christoph Brackmann added that NovoCure is also considering a trial in its approved locally advanced, first-line setting with a KRAS agent that has not yet been approved.
International Launches and Profitability
NovoCure operates in 16 countries and has begun launching Optune Pax for pancreatic cancer in Germany following CE mark authorization. Leonard said the company expects a country-by-country European expansion, with reimbursement discussions likely to take time in markets such as France. He estimated that the European pancreatic business could take more than a year to mature.
In Japan, NovoCure expects a regulatory decision for Optune Pax by the end of the year and reimbursement approval during the first half of the following year. Leonard said pancreatic cancer has a higher prevalence in Japan than in the U.S.
The company also launched its Optune Lua device for second-line, Stage IV non-small cell lung cancer at the end of 2024. Leonard said the U.S. launch has faced challenges because the standard of care shifted, but the initial Japanese launch has performed well because local treatment guidelines more closely align with the company’s pivotal-trial data.
Brackmann said NovoCure’s profitability plan has three stages: adjusted EBITDA break-even, cash-flow break-even and, ultimately, GAAP net-income break-even. The company has guided for at least adjusted EBITDA break-even by year-end, with the potential for up to $50 million of positive adjusted EBITDA.
At its latest report, NovoCure had roughly $440 million in cash and $200 million in debt. Brackmann said the company believes its current balance sheet is sufficient and does not expect to need to access capital markets in the near term. He added that R&D and general and administrative expenses are not expected to grow materially, while sales and marketing spending may rise moderately to support launches.
About NovoCure (NASDAQ:NVCR)
NovoCure Ltd. (NASDAQ: NVCR) is an oncology company that develops and commercializes Tumor Treating Fields (TTFields), a noninvasive therapy that uses low-intensity, intermediate-frequency electric fields to disrupt the division of cancer cells. The company’s technology is designed to be used alongside other cancer treatments and is delivered through a portable device and transducer arrays placed on the patient’s body.
NovoCure’s principal commercial products include Optune Gio, used with other treatments for adults with certain forms of glioblastoma, and Optune Lua, approved in the United States for use with certain therapies in adults with unresectable, locally advanced or metastatic malignant pleural mesothelioma.
