Good day, ladies and gentlemen, and welcome to the Novocure First Quarter 2017 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded. I would like to introduce your first speaker for today, Ashley Cordova, Vice President of Finance and Investor Relations. You have the floor, ma'am.

Good morning, everyone, and thank you for joining us to review Novocure's first quarter 2017 performance. I'm joined today by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; our CFO, Wilco Groenhuysen; and our Chief Science Officer and head of Research and Development, Eilon Kirson. The slides that will be presented today can be viewed on our website, www.novocure.com, by clicking on the link for 2017 first quarter financial results located in the Events section on our Investor Relations page. Before we start, I'd like to remind you that our discussions during this conference call will include forward-looking statements and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control, including those risks and uncertainties described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statements except as required by law. We will first make some brief prepared remarks and then move on to a question-and-answer session. I will remind everyone that our financials for the three months ended March 31, 2017 are available in our press release and our 10-Q, both of which were released earlier this morning. With that, I’ll now turn the call over to Bill Doyle.

Thank you, Ashley, and good morning everyone. Novocure continues to implement a simple two-pronged strategy which should sound familiar to everyone on this call. We are focused on driving commercial adoption of Optune for the treatment of glioblastoma, and we are committed to developing TTFields for a variety of other solid tumors. We made significant progress on both fronts in the first quarter of 2017. Earlier this month, at the American Association for Cancer Research Annual Meeting, Professor Roger Stupp presented the final analyses of our EF-14 Phase III pivotal trial of Optune in combination with temozolomide for patients with newly diagnosed GBM. The final analyses included the full 695 patient data set with a median follow-up of 40 months from randomization. Consistent with earlier analyses of EF-14 data, combining Optune with temozolomide demonstrated unprecedented long-term survival rates. Patients treated with Optune plus temozolomide experienced significantly greater one-year, two-year, three-year, four-year, and five-year survival rates. At years four and five, the survival rates for patients treated with Optune plus temozolomide were more than double the survival rates of patients treated with temozolomide alone. Consistent with prior EF-14 analyses, these data confirmed an overall survival benefit for patients using Optune across all patient subgroups, including both young and elderly patients, patients with methylated and unmethylated MGMT promoter status, and patients with any tumor resection status. Prior to the introduction of temozolomide over a decade ago, the majority of GBM patients died within one year of diagnosis and five-year survival was essentially absent. Now, with the combination of Optune and temozolomide, median overall survival is more than two years from diagnosis and one out of seven patients is living longer than five years. These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly…

Thank you, Bill, and good morning everyone. Q1 was a period of study commercial growth, which represents our best quarter ever for each of our key commercial metrics. Growth was consistent across all geographies and target customer segments. Importantly, we had 1,266 active patients on therapy at the end of March, including more than 930 active patients in the US and more than 240 active patients in Germany. This represents a 59% increase in global active patients since Q1 2016 and a 16% increase in global active patients versus Q4 2016. We believe the first quarter growth benefited from momentum related to the presentation of our EF-14 long-term analysis at SNOW in November 2016. Feedback from the field has been that the consistent and maintained improvement in overall survival shown in long-term analysis of the full 695 patient data set was meaningful to our prescribers. We understand that the strength of a physician's commitment to Optune as an essential treatment for GBM is vital to patient acceptance. The long-term data presented at SNOW confirmed the survival and safety results shown at the interim analysis of EF-14, and were a validation of the benefits of Optune for the prescribing community. Physicians must also gain confidence and experience recommending Optune to their patients. We have developed targeted tools to support physician-patient dialogue, and this continues to be an area of focus for us. Beyond building awareness of the EF-14 data within the GBM community, we have also made significant progress building awareness of Optune and TTFields in the broader medical community and among the general public. The presentation of our landmark five-year survival data at AACR, together with the presentation of promising Phase II pilot trial results in pancreatic and ovarian cancer, generated significant media coverage. More than 300 media outlets, including the Associated Press and The Washington Post, ran stories on Optune in the first two weeks of April, highlighting the landmark five-year survival benefit of adding Optune to the standard of care for GBM. Many of the stories featured one of our patients sharing their personal experience with Optune. Before handing the call over to Wilco to review the first-quarter financials, I want to reflect on the progress we have made in our commercial business. It is remarkable to me that more than 5,000 patients have now been treated with Optune. I believe we have the tools in place to continue to drive adoption, and I am committed to bringing Optune to as many patients as possible who may benefit from it. With that, I will hand the call over to Wilco.

Thank you, Asaf, and good morning everyone. First quarter 2017 was the ninth consecutive quarter of active patient and revenue growth since the presentation of our EF-14 interim analysis at SNOW in November 2014. First-quarter 2017 net revenues increased to $34.9 million compared to $30.1 million for the same period in 2016, representing 167% growth. Sequentially, net revenues for Q1 were up 15% from the fourth quarter of 2016. Revenue growth was driven by increased Optune adoption in our active markets as well as transition to accrual-based revenue recognition for a portion of our billings. Importantly, we continue to execute on our commitment to substantially improve operating leverage. While our revenue grew by 167%, our operating expenses did not grow. We continue to work with payers to expand coverage for Optune and continue to negotiate contracts to establish Optune with an in-network benefit. As of March 31, 2017, we had more than 187 million US lives under positive coverage policies. We also had contracts negotiated establishing Optune as an in-network benefit for more than 137 million lives. We continue discussions with public payers in our other active markets. In March 2017, we filed an application with the MHLW to secure defined reimbursement rates for Optune based on the December 2016 regulatory approval of Optune for newly diagnosed GBM in Japan. Q1 net revenues include $14.7 million in the accrued base net revenues, which drove an increase in trade receivables of $5.5 million. On a comparable all-cash basis, first-quarter 2017 net revenues would have been $29.4 million, representing 126% growth versus the first quarter of 2016, and 13% growth versus the prior quarter. 23% of our first-quarter 2017 gross billings qualified for accrual-based revenue recognition. I will remind you that gross billings reflect the total charges for active patients on therapy…

[Operator Instructions] We will taking our first question from the line of Tao Levy from Wedbush. Your line is open

Just a couple of questions on my end. You know, first, maybe you could comment on the trends that you've seen since the presentation of the five-year data. You mentioned you've got a lot of press attention and patient advocates out there. I'm just curious to see if the trends had changed at all versus what you had experienced in the first quarter.

This is Bill. Just to put this in the timeline, the presentation of the five-year data was at AACR in April, so it's actually a Q2 event. And as you know, we don't guide, so I think you're going to have to stay tuned to see the effects of that particular data set. I will say that the - if you recall, at SNOW, we presented the first long-term analysis, so that was the first time that the full 695 patient data set was presented to the community. That included four-year survival, not the five-year survival. Those data were well received and I think, along with all the other things that we've been doing, contributed to the momentum that we saw in the quarter.

Great. And maybe you could update us on Medicare reimbursement. I know you've been intensely focused on that in the past.

Sure. So, I think that, as we reported again last year, we've had tremendous success in both coverage and contracting in the private pay market in the US. That represents between 75% and 80% of the GBM market. That leaves another 20% to 25%, which is the Medicare fee-for-service where we do not yet have reimbursement. It's very typical in the device world to establish the reimbursement in the private market first and then move to Medicare. A number of the things that we accomplished in 2016 were prerequisites for that. And again, those of you who have participated in these calls will recall, starting with FDA approval, the peer review publication of our interim data in JAMA, as well as the SNOW data that we just referred to. We have now and are assembling the AACR data. One of the sub analyses in that particular data set included the elderly GBM subgroup. And that analysis that Dr. Stupp presented showed among the best benefit for TTFields in terms of hazard ratio improvement in the elderly GBM. So, we are fully engaged. We don't have a timeline, but I think we have assembled everything that CMS needs. We are actively engaged. I will say, now - we have a new head of Health and Human Services and CMS have both been recently confirmed. So we now have people in the right jobs and this is something that we are intensely focused on.

Thank you. Our next question comes from the line of Gregg Gilbert from Deutsche Bank. Your line is open.

Thanks. I have a couple. The following up on that CMS angle, Bill, are you still confident you will collect the cash you believe you are owed and, secondly, secure a reimbursement price going forward, consistent with your expectations?

You know, it's hard to be confident with anything related to the government. I would say that I am more - I feel better about receiving the reimbursement for patients going forward at an acceptable rate. I think whether we receive payment for the patients - and just to remind everybody on the call, notwithstanding the fact that we do not have CMS reimbursement, we've made the decision as a company not to deny Optune therapy to Medicare patients. That's been a steadfast pillar of our commitment to this patient community. We do bill the government for those patients. They are - those bills are stuck in their very backlogged process for adjudication. We are going to do everything we can to get paid for those claims, but I would say that's harder to put a probability on.

Okay. As it relates to the sequential growth in prescriptions from 4Q to 1Q, do you have any data you can share in terms of the number of prescribers to give us a feeling for how many skeptics were sort of won over by the complete EF-14 data set?

It's Asaf. So, I think that the number of prescribers is growing and what we are seeing in the last two-and-something years that the trend is that the skeptics are moving to our side and as they - I can tell you one of them said that last week that he cannot ignore it anymore basically on the - with the five-year survivors. So all in all, we - if I need to - we see the trend on the right direction.

Okay. And then, lastly, maybe you could provide a little more color on how the ramp in prescriptions outside the US is going. I mean, we see with the ramp, but can you give us some color on the individual regions and processes that are helping drive that momentum? Thanks.

So, out of US, we mainly focus on Germany, and this is our main market outside the US. And we continue to see growth in active patients and in prescriptions. I can say that Germany is also following the US with - everything is going to the right trends and we - and you can see that, over the last couple of quarters that we continue to see more patients on treatment.

Is there any debate around reimbursement in Germany like there is it with Medicare, or not?

So in Germany, right now, we are working on - actively working on national reimbursement. The system over there is different. So, we do believe that we are also in the right direction with national reimbursement, but we cannot of course give any guidance about it.

Thanks.

Thank you. Our next question comes from the line of Mike King from JMP Securities. Your line is open.

Congrats on the nice sequential growth. I wanted to ask you, if we look at the script growth versus revenue growth, it seems like you are getting a lot of growth, revenue growth, in excess of script growth. So, I just wonder if you want to maybe comment on the duration of therapy that you have seen now and how that might compare with, let's say, a year ago. And then I have some follow-up financial questions for Wilco.

Good morning Mike. This is Wilco. As we discussed in the past a number of times, script growth is a leading indicator leading to active patient growth. And active patients on therapy are actually the leader for revenue recognized and gross billings, as you know. And historically, you've seen quarter after quarter after quarter growth in active patients. We were close to 1,300, I think 1,266 to be exact, at the end of the quarter. It's a function of patient starts, treatment duration, but on those individual components, unfortunately, what we said in the past, that some of the data that we shared on EF-14 and the median survival data that we saw, duration of therapy that we shared in EF-14 is still the best guidance that we have right now.

Okay, thanks for the color there. And then look, I know you were - and I apologize because I'm trying to jump between a bunch of different earnings calls this morning. And I know you were talking about gaining operating leverage. But, given all the Phase IIIs you've got ongoing plus the Phase IIs that are likely to flip to Phase IIIs, it just seems to me that, at some point, we're going to have to see a re-acceleration of R&D growth. So, I don't know how far out you can comment about that, but just wondering what you might want to say.

I'd like to comment on our focus on operating leverage. So, as we said during the call, our top line grew by 167% compared to Q1 of last year, while our operating expenses remained flat. That was partially due to R&D, which decreased a little bit with EF-14 ending and the new Phase III trials just starting up. We expect those R&D costs to pick up a little bit going forward since we are fully committed to executing the clinical pipeline, as we've also shared with R&D. Our true focus for operating leverage is on SG&A expenses. So, we are committed to making the organization more efficient and to continue to drive the operating leverage, particularly through SG&A expenses.

Maybe another comment on that. It takes a certain base infrastructure to be a global oncology company, and that is constant, whether we have one patient or whether we have many, many more patients. We feel that we've built that infrastructure and now we can build upon it. And I think what we demonstrated over the last year supports that.

Okay, great. And then finally, how should we think about the proportion of revenue that is attributed to accrual versus cash accounting? Do we want to think about that proportion growing with time? And I don't know if we can speculate about what kind of a ramp that growth might take, but any color you can provide on that would be helpful as well. Thanks.

Yeah. This is Wilco again. We expect it to grow of course. It was 23% of gross billings in the first quarter. We did not recognize accrual-based revenue for non-US-based patients or payers, so we would expect that to kick in over time. Overall, in the US, this was our first quarter of basically contracting with some of the larger payers. It's not uncommon in the industry and we experienced it to some extent as well that there's some early process change that need to be worked out. They are in the process of being worked out or have worked out. So, we would also expect that the proportion of US revenue that qualifies for accrual-based rev rec will increase as well.

Thank you.

Thank you. Our next question comes from the line of Cory Kasimov from JPMorgan. Your line is open.

This is Whitney on for Corey. I just wanted to follow-up on a prior question around the number of prescribers. Are there any quantitative metrics you can give us around either the number of docs prescribing or an increase over time, or the percent of targeted docs that are prescribing, or anything sort of more quantitative you can say there?

We don't have any quantitative numbers in this particular release. Just to repeat what Asaf said, we are seeing increases in all groups internationally and in the US, and that includes neuro-oncologists. But, very importantly, and we've mentioned this before, radiation oncologists and neurosurgeons are becoming important prescribers. So, I think all the efforts that we put into spreading the word in 2016 and [Technical Difficulty] have really begun to show affect.

Okay, got it. And then I believe you had previously talked about presenting additional quality-of-life types of analyses or things in that vein from EF-14. Should we be expecting additional updates in that vein this year? Or what else should we expect from EF-14, if anything, this year?

Eilon, do you want to comment on that question?

Sure. We are planning on presenting quality-of-life analyses of the EF-14 trial in an upcoming medical conference. And in addition, there will be likely additional analyses with subgroups within the EF-14 data set, which will be available for future presentation as well.

Great, thanks for taking the questions.

Thank you. Our next question comes from the line of Difei Yang from Aegis Capital. Your line is open.

Just a couple. Would you remind us on how the Japanese reimbursement process works? And are you still expecting to secure reimbursement by the end of 2017? And then before you get the reimbursements, is it reasonable to assume the patient or the prescription growth in that region will be fairly minimal?

Japanese reinvestment, as we - I would just like to remind you that the process in Japan will receive our PMDA approval, which is equivalent to the FDA approval, for newly diagnosed GBM early this year - I'm sorry, it was late last year. And we filed the reimbursement package to MSAW. And we are in the process to secure reimbursement in Japan, and we feel comfortable that this will happen.

Thanks for that update. Just to circle back to the Medicare discussion, so is there a mechanism or a way that you can submit the additional five-year survival data into the CMS to be a as part of the conversation, or how often do you get to update the CMS?

The answer to your question is just simply absolutely yes. And we update CMS with all relevant, new information, so there's no specific limit to our conversations. And I would say that we have now a very constructive and open dialog with CMS and also the other relevant parties in Washington who have an interest in making sure that Medicare beneficiaries have access to all of the latest medicine. So they get all of our data.

Okay, thank you. So, my final question is with regards to the accrual method versus the cash method. So, obviously, that portion is growing, and I'm just trying to look forward to 4Q of 2017. Is it reasonable to assume the accrual portion probably more in the 30% range rather than 50%? I'm just trying to get a bookend kind of feel for what is reasonable.

This is Wilco again. As you know, we do not provide guidance, and this would be guidance. I can only repeat what I said earlier on that. During the year, we would expect overseas revenues to qualify for accrual-based rev rec. And we also expect that the proportion of our US revenue that qualifies for accrual-based rev rec will increase. Whether that will lead to 30s or 50s percent is something that the next few quarters will show, but it will go up.

Okay, thank you.

Our next question comes from the line of Lei Huang from Wells Fargo. Your line is open.

It's Lei calling in for Larry Biegelsen. Thanks for taking the questions. I want to start with the US prescription growth. We had nice sequential growth, 26%, but it was essentially flat year-over-year. Why - I guess why wasn't there more of a year-over-year increase? You did have SNOW data towards the end of year with the final 692 patient data, four-year survival. So, I guess I was expecting a bit more of a bump year-over-year in the prescription number.

It's Asaf. I think that the right barometer is to look at what's happened to patients on treatment, and this is of course the power method that predicted revenue. So, if you look not year-over-year, years-over-years, of patients on treatment, you see continuous growth quarter-over-quarter in the last nine quarters.

Okay. Just in terms of the split between newly diagnosed and recurrent GBM patients, it's been that 50% to 55% range for the last year or so. At what point should we expect that mix to change, maybe move towards more of the newly diagnosed patients?

I think that the - since we received the approval for newly diagnosed GBM, we've seen quite an increase. It has steadily, as you said, reached the mid to high 50s. We see, from our data, that patients absolutely benefit when they - the earlier that they start Optune therapy. And so part of our communications in the community is to make sure that clinicians and patients understand the benefits of starting at the time of diagnosis. I think all the things that we've done, and we'll see with the AACR data, but that clearly supports that same message. That said, there will always be some percentage of patients that go into clinical trials and then take Optune therapy when they have progressed from their clinical trials. And so I would expect that number to continue to rise, but there will always be a recurrent component.

Okay. And then last question, on the ovarian cancer study, so you presented the pilot data last month, but immediate overall survival had not been reached yet. Do you expect to have that final data before you start the Phase III trial next year?

Eilon?

Sure. So, the predefined follow-up for the trial has been reached already, and so the data that we have today is pretty much the full data set and the final data that will be presented. We are going to use this to predict the necessary sample size to plan the Phase III trial.

Okay, got it. Thanks very much.

Thank you. Our next question comes from the line of Mike King from JMP Securities. Your line is open.

Thanks for taking the follow-up, guys. Just a quick question. What is your intention, if any, to supplement the product label with the most recent data update from EF-14 for the five-year survival?

It's Asaf. We are definitely going to update and discuss it with the FDA, so it's part of our plan.

Is that a this year event?

You know, it's not easy to predict FDA's timeline, but this is something that we will start this year, absolutely.

Thank you.

Thank you. Our next question comes from the line of Mayur Tipnis from Courage Capital. Your line is open.

Guys, just a couple of follow-up questions. With all the new commercial lives that we've signed up for, what's the trend in net price per month per patient? And then if you could also just kind of give me some qualitative comments about the net price per patient across the regions, you know, US, Germany, as you've been starting to get more reimbursement? Thank you.

This is Wilco again. Thanks for the question. As you know and we've disclosed that in the past, our list price is $21,000 in the United States. In Europe, it's about EUR21,000. We've spoken in the past on average collection on payments that were made basically focused on the United States. With the switch to accrual-based rev rec, that's something that we do not do anymore. Overall, we see no significant changes in payment trends. As Asaf explained earlier on and I think it was also an earlier question, we are putting a lot of work and effort into securing reimbursement in some of the overseas territories, particularly Japan, Germany, and Switzerland. And Bill talked earlier on about Medicare. How that all will shake out in terms of net revenue or net revenue per patient is something that we'll see in the future.

Thank you. Ladies and gentlemen, this now concludes our question-and-answer session for today. I'd like to turn the call back over to management for closing comments.

So, first of all, thank you, everyone, for joining us this morning. We appreciate your continued interest in Novocure. I have to say that, when I look back on 2016 and the progress to date, I want to be sure to congratulate the Novocure team, starting with FDA approval in October 2015, peer-reviewed publication of the interim data at JAMA in December of 2015, inclusion of Optune as a standard therapy for GBM and the NCCN guidelines in July, the rollout of the Gen 2 device in the summer of last year, all the progress that we made, particularly in Q3 and Q4, in coverage and contracting, the publication of the full data set, including four-year data at SNOW in November, the growth of the sales force from 33 members in the US to 58 members, training centers growing from 244 training centers in the US to 538 training centers in the US, the receipt of Japanese approval, and now the publication of landmark five-year data, it's really been an extraordinary period of accomplishment and I want to again congratulate the team for all their hard work. So, thanks again everyone.

Ladies and gentlemen, thank you again for your participation in today's conference call. This now concludes the program and you may now disconnect at this time. Everyone have a great day.