In 2017, Novocure’s efforts were focused on three objectives. First, bring Optune® to adult patients with glioblastoma (GBM) in our active markets. Second, advance our clinical pipeline for a range of solid tumor cancers in which we believe Tumor Treating Fields can help patients. Finally, operate in a way that is fiscally responsible and begin to realize leverage within our organization. We are happy to report to you, our shareholders, that we made measurable progress toward these objectives in 2017.
Last year marked a year of solid performance in our commercial business. We expanded the number of active patients on treatment by 68 percent and grew the number of prescriptions written for Optune by 47 percent compared to 2016. We improved patient access to our therapy by continuing to sign contracts with private payers in the United States and by gaining national reimbursement approvals in Austria and Japan. We started the formal process toward national reimbursement in Germany.
In December 2017, we published the final analysis of our EF-14 phase 3 pivotal trial in newly diagnosed GBM in the Journal of the American Medical Association (JAMA). These results demonstrated that more than one in eight patients with newly diagnosed GBM who were treated with a combination of Optune and temozolomide survived for five years versus one in twenty patients who were treated with temozolomide alone.
In November 2017, we presented data from a post-hoc subgroup analysis of our EF-14 trial that demonstrated a statistically significant extension of survival starting at 12 hours a day of Optune use. In EF-14, 43 patients who wore Optune 90 percent or more of the time had an estimated 30 percent chance to survive five years.
We also made progress in our research and development efforts in 2017. At year-end, we had three phase 3 pivotal trials open to study Tumor Treating Fields in combination with standard of care treatments versus standard of care treatments alone in brain metastases from non-small cell lung cancer, non-small cell lung cancer and pancreatic cancer. We successfully scaled our clinical teams in 2017 to run multiple clinical trials, and we are poised to continue progressing our clinical pipeline.
Novocure’s next data readout will be in mesothelioma, the lung cancer associated with asbestos exposure. We enrolled the last patient in our STELLAR phase 2 pilot trial in March of 2017 and received a Humanitarian Use Device designation for Tumor Treating Fields for the treatment of patients with pleural mesothelioma in May 2017. This opens up the possibility to apply for a Humanitarian Device Exemption (HDE) based on strong phase 2 pilot data.
We finished 2017 in a strong cash position with $183.3 million in cash on our balance sheet as of December 31, 2017, providing us with the financial stability and flexibility to continue to execute on our core objectives. In February 2018, we further strengthened our cash position when we entered into a new $150 million term loan agreement to replace our existing $100 million term loan debt. Moving forward, we remain focused on the disciplined management of gross margin and SG&A expenses in order to build a profitable business.
Novocure is a global oncology company with a proprietary platform technology, a growing commercial business and significant upside potential. Looking ahead, we are focused on two clear priorities. First, drive commercial adoption of Optune. Second, advance our clinical pipeline. We enter 2018 well positioned to execute on both fronts.
We are committed to building long-term shareholder value and investing responsibly for our future growth. Thank you for your continued support of Novocure.
Growing commercial business with more than
patients treated as of December 31, 2017
Proprietary platform technology with Preclinical data in
Chief Executive Officer
Novocure is a global oncology company developing a proprietary platform technology called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.
Optune, our first Tumor Treating Fields delivery system, is approved for the treatment of adults with GBM and has demonstrated unprecedented five-year survival results when used in combination with temozolomide in a large, randomized, phase 3 pivotal trial for patients with newly diagnosed GBM.
We believe that GBM represents just the beginning of our journey. In our preclinical work and clinical work to date, Tumor Treating Fields has shown a consistent anti-mitotic effect. Our clinical pipeline includes a range of solid tumor cancers with significant unmet medical need.
invested in research & development during 2017
IN CASH, CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS AS OF DECEMBER 31, 2017
— WILCO GROENHUYSEN,
Chief Financial Officer