Wilco Groenhuysen
Analyst · Greg Fraser of Deutsche Bank. Your line is now open
Thank you Asaf and good morning everyone. Fourth quarter 2016 net revenues increased to $30.2 million, compared to $12.4 million for the same period in 2015, representing 144% growth. Our non-U.S. business generated $3.7 million in net revenues during the quarter, up 247% from last year. Sequentially, net revenues for Q4 were up approximately 40% from the prior quarter. For 12 months ended December 31, 2016 net revenues increased to $82.9 million, compared to $33.1 million for the same period in 2015, representing 151% growth. It is important to note that Q4 net revenues included $8.5 million in accrual based net revenues, including $4 million in net revenues for which cash had not yet been collected at quarter end. On a comparable all-cash basis, fourth quarter 2016 net revenues would have been $26.2 million, representing 111% growth, versus the prior year and 21% growth versus the prior quarter. You will note that in our 10-K and the slides accompanying this webcast, we provide a new table in our financial disclosure that includes gross billings and a breakout accrual-based versus cash-based net revenues associated with these gross billings. Gross billings reflect total charges for active patients on therapy without any deductions or adjustments for payer discounts, patient financial assistance or charitable care. 19% of our fourth quarter 2016 gross billings qualified for accrual-based revenue recognition. All of the net revenues recognized on accrual basis represent charges to U.S.-based third-party payers driven by the increase in positive coverage policies and negotiated contracts, which enabled us to estimate a fixed and determinable amount that would ultimately be collected from these payers. We continue to recognize revenue on a cash basis for the remaining payers, with whom we do not have contracts and with whom we have not build up sufficient history to reliably estimate their individual payment patterns. We anticipate there will be an extended period of time when our revenue is a mix of cash-based and accrual-based revenue. Cost of revenues for the fourth quarter 2016 were $11 million, an increase of 74% from the same period in the prior year. This compares to an 85% increase in gross billings from the same period in the prior year and reflects margin improvement resulting from an increase in active patient volume. For the 12 months ended December 31, 2016, cost of revenues excluding the second quarter impairment loss, increased to $39.9 million, compared to $20.6 million for the same period in 2015, representing 94% growth. Additionally, we had a $6.4 million impairment loss with respect to the write-off of our first generation Optune System field equipment in the second quarter. Operating expenses during the fourth quarter 2016 were $37.1 million, including $15.7 million in sales and marketing expenses, $8.5 million in research and development expenses and $13 million in G&A expenses. This compares to operating expenses of $36.7 million during the fourth quarter of 2015 and represents an increase of 1% year-over-year. This increase in operating expenses was primarily driven by an increase in sales and marketing expenses stemming from the expansion of our salesforce and other commercial functions to support the promotion of Optune for newly diagnosed GBM and an increase in G&A expenses. These increases were partially offset by a decrease in research and development cost stemming from the conclusion of our EF-14 pivotal trial in newly diagnose GBM. We expect to further improve operating leverage in 2017. For the 12 months ended December 31, 2016, operating expenses were $151.9 million, including $59.4 million in sales and marketing expenses, $41.5 million in research and development expenses and $51 million of G&A expenses. This compares to operating expenses of $116.5 million for the 12 months ended December 31, 2015 and represents an increase of 30% year-over-year. Net loss for the fourth quarter 2016 was $22.2 million, compared to $32.9 million for the same period in 2015. Net losses for the 12 months ended December 31, 2016 were $131.8 million, compared to net losses of $111.6 million for the same period in 2015. Our fourth quarter 2016 net cash used in operating activities was $13.7 million. In addition, we have invested $3.4 million in PP&E and field equipment to support our commercial business. Net cash used in operating activities for the fourth quarter 2016 was favorably impacted by approximately $9.1 million in one-time events, as well as temporary improvement in working capital. As of December 31, 2016, we had $99.8 million in cash and cash equivalents and $119.9 million in short-term investments for a total balance of $219.6 million in cash, cash equivalents and short-term investments. Entering 2017, we believe we have established a strong foundation upon which we are building a global oncology business. We realized 2016 net revenues of $82.9 million, an increase of more than 150% versus the prior year. We improved our ability to collect payment by improving coverage and contracting in the U.S. And we saw significant active patient and revenue growth in EMEA. We presented the long-term analysis of EF-14 data in which Optune plus temozolomide demonstrated unprecedented long-term survival compared to temozolomide alone through four years. We announced promising top line results in our phase 2 pilot programs in pancreatic cancer and ovarian cancer and also announced encouraging interim results from a phase 2 pilot trial in mesothelioma. Ending the year with $220 million cash on hand and with our infrastructure substantially built, we believe we have the resource to reach profitability in our GBM business alone. With that, I would like to thank everyone for their time this morning and for the interest in NovoCure. Operator, can we please poll for questions?