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Novocure Reports Second Quarter 2016 Financial Results and Provides Company Update


Novocure (NVCR), a commercial stage oncology company pioneering a novel therapy for solid tumors, today reported financial results for the quarter ended June 30, 2016, highlighting year-over-year growth in prescriptions, active patients and reported revenues.

Second quarter 2016 highlights include:

Three months ended June 30,
2016 2015 % change
Prescriptions received in period(1) 657 428 54 %
Active patients at period end(2) 891 425 110 %
Financial, in millions (unaudited)
Revenues(3) $ 17.9 $ 6.5 174 %
Net loss $ (40.6 ) $ (29.4 )
Cash and cash equivalents at the end of period $ 80.9 $ 106.5
Short-term investments at the end of period $ 120.0 $ 57.0

(1) A “prescription received” is a commercial order for Optune that is received from a physician certified to treat patients with Tumor Treating Fields (TTFields) therapy for a patient not previously on TTFields therapy. Orders to renew or extend treatment are not included in this total. In the future, we may have regulatory approvals and commercial programs for multiple clinical indications, at which time we will recognize a commercial order as a prescription for the same patient for each clinical indication treated. For example, in the future, a patient may have a prescription for the treatment of lung cancer and a prescription for the treatment of brain metastases from the lung cancer.

(2) An “active patient” is a patient who is on TTFields therapy under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) For the reported periods, all revenues were recognized when cash was collected and all other revenue recognition criteria had been met.

“Year-over-year prescription, active patient and revenue growth continues and I am proud of the progress we have made since the FDA approval of Optune for newly diagnosed GBM in October 2015. We finished the quarter with 547 prescriptions in the United States and 110 in our ex-U.S. markets,” said Asaf Danziger, Chief Executive Officer. “While barriers to full adoption remain, I am optimistic we will overcome the challenges inherent in bringing a completely new therapy into widespread clinical use.”

“Earlier this week, the National Comprehensive Cancer Network, or NCCN, updated its clinical practice guidelines to add Optune plus temozolomide as a Category 2A treatment option for newly diagnosed GBM. Optune is transforming the standard of care for glioblastoma,” continued Mr. Danziger. “Also this month, we received FDA approval for the smaller, lighter second generation Optune System which aims to make Optune therapy even easier for patients. And, later this year, we will publish additional clinical trial data further demonstrating the benefits of Optune therapy for GBM patients.”

“Optune is the first therapy to demonstrate an improvement in overall survival for newly diagnosed GBM patients in more than a decade and we are committed to bringing this therapy to patients who have such a vital need for improved treatment options,” concluded Mr. Danziger.

“Scientific evidence suggests TTFields therapy is broadly applicable to solid tumors; and our R&D team continues to make progress toward developing TTFields for additional tumor types,” said William Doyle, Executive Chairman. “In the past three months, we enrolled the last patients in our PANOVA and INNOVATE phase 2 pilot trials in advanced pancreatic cancer and recurrent ovarian cancer, respectively, and received FDA approval of our IDE application to initiate our METIS phase 3 pivotal trial in brain metastases.”

“Recent findings strengthen our belief that treatment with TTFields is compatible with both current standards of care and emerging novel therapies for a variety of solid tumors and we are excited to share data from multiple indications at our R&D day in December,” continued Mr. Doyle. “We believe that TTFields, with the potential of superior outcomes and no systemic toxicity, will play a valuable role in the solid tumor treatment paradigm.”

2016 Second Quarter Operating Statistics and Financial Update

Prescriptions in the quarter ended June 30, 2016, increased by 229 prescriptions, or 54 percent, compared to the same period in 2015. The increase in prescriptions was driven primarily by commercial activities in the United States after the October 2015 U.S. Food and Drug Administration (FDA) approval of Optune for the treatment of newly diagnosed glioblastoma (GBM), increased commercial activities in Germany, and enhanced awareness of Optune following the December 2015 publication of EF-14 phase 3 pivotal trial results in the Journal of the American Medical Association.

  • In the United States, 547 prescriptions were received in the quarter ended June 30, 2016, an increase of 157 prescriptions, or 40 percent, compared to the same period in 2015.
  • In Germany and other EMEA markets, 110 prescriptions were received in the quarter ended June 30, 2016, an increase of 72 prescriptions, or 189 percent, compared to the same period in 2015.

There were 891 active patients on Optune therapy at June 30, 2016, an increase of 466 active patients, or 110 percent, compared to June 30, 2015. The increase in active patients was driven both by prescription growth and by an increase in the percentage of newly diagnosed GBM patients who started Optune in prior periods. The portion of Optune prescriptions for newly diagnosed GBM was more than 50 percent in the second quarter of 2016.

  • In the United States, there were 736 active patients on Optune therapy at June 30, 2016, an increase of 345 active patients, or 88 percent, compared to June 30, 2015.
  • In Germany and other EMEA markets, there were 155 active patients on Optune therapy at June 30, 2016, an increase of 121 active patients, or 356 percent, compared to June 30, 2015.

We continued to expand coverage of Optune for the treatment of...