Good day, ladies and gentlemen, and welcome to the Novocure fourth quarter 2017 earnings results conference call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Ashley Cordova, Vice President of Finance and Investor Relations. Ma'am, you may begin.

Good morning, everyone, and thank you for joining us to review Novocure's fourth-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 presented today can be viewed on our website, www.novocure.com by clicking on the link for the 2017 fourth quarter financial results located in the Events section on our Investor Relations page. Before we start, I would 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 statement, except as required by law. We will first make brief prepared remarks and will then move to a question-and-answer session. I will remind everyone that our financials for the three months and year ended December 31, 2017 are available in our press release and our 10-K really, both of which were released earlier this morning. With that, I will now turn the call over to Bill Doyle.

Thank you, Ashley. And good morning, everyone. For those of you who are new to our story, I'd like to start today's call with a quick summary of Novocure's investment opportunity. Novocure is a global oncology company with a proprietary platform technology, a growing commercial business and significant upside potential. We have a clearly articulated strategy for building long-term value. First, we're driving commercial adoption of Optune for the treatment of GBM. Second, we are advancing our clinical pipeline in a range of solid tumor cancers, in which we believe Tumor Treating Fields can help patients. Tumor Treating Fields, our proprietary platform, is a cancer therapy that uses electric fields to the specific frequencies to disrupt cell division, inhibiting tumor cell growth and causing effective cancer cells to die. In all of our preclinical work and clinical work to date, Tumor Treating Fields has shown a consistent anti-mitotic effect. We have unprecedented five-year survival results in newly-diagnosed GBM, promising Phase II pilot data in lung cancer, pancreatic cancer and ovarian cancer and preclinical data in 18 different cancer cell lines. Importantly, Tumor Treating Fields has been shown to be additive or synergistic with certain anti-cancer agents, while exhibiting no known systemic toxicity and a mild side effect profile. We believe that Tumor Treating Fields will fit side-by-side with the other cancer treatment modalities of surgery, radiation therapy and pharmacology. I'll make some comments regarding our future potential later in this morning's call, but, first, I'll ask Asaf to review our progress during the fourth quarter 2017. Asaf?

Thanks, Bill. With more than 1,800 patients on therapy at year-end, the fourth quarter of 2017 was our 12th consecutive quarter of active patient growth since the initial presentation of our year 14 Phase III pivotal data. We delivered record revenue of $53.7 million in Q4 2017, growing 77% year-over-year and 7% quarter-over-quarter. For the full year, we delivered $177 million in net revenues, representing 114% growth year-over-year. I'm proud of the progress we made in 2017. We saw notable shift in prescription mix during the fourth quarter of 2017. 66% of our prescriptions were written for patients with newly-diagnosed GBM. This move towards newly-diagnosed GBM should allow active patient growth to continue to outpace prescription growth in future quarters. For Q4 2017, we estimate the global penetration rate of 22% in our currently active markets. Our first commercial priority on any market is to generate awareness of Optune and of our unprecedented five-year survival data in newly-diagnosed GBM. As of December 31, 2017, we had more than 1,100 certified centers globally, including 714 certified centers in the United States and 245 certified centers in EMEA. We believe we have achieved high levels of awareness in the US and Germany among neuro-oncologists and neurosurgeons who treat GBM. Neuro-oncologists and neurosurgeons wrote approximately 58% of our Q4 prescriptions. We remain focused on developing awareness among radiation oncologists and medical oncologists who treat GBM. Radiation oncologists are our second largest and fastest growing customer segment and represented about 28% of our Q4 prescription. Once awareness is established, our commercial priorities shift to increasing physician confidence and believing Optune as a standard treatment for GBM. We believe that the strength of a physician's recommendation for use of Optune closely correlates with the percentage of patients who start therapy with Optune. We achieved two…

Thank you, Asaf. In addition to our commercial progress during the fourth quarter, our continued investments in R&D have led to meaningful advances in our understanding of Tumor Treating Fields and to significant increases in the data available for publication and presentation at scientific congresses. Our presence at the Society For Neuro-Oncology Annual Meeting in November included 60 abstract presentations, 47 of which had an external lead author. This was a record number of abstracts on Tumor Treating Fields at SNO and demonstrates what we believe to be a growing interest in Novocure's cancer therapy among researchers and clinicians throughout the world. In December, we published preclinical research in radiation oncology demonstrating that Tumor Treating Fields delays DNA damage repair following radiation treatment of glioma cells. This research describes an antineoplastic treatment pathway by which Tumor Treating Fields potentiates the effects of radiation and strengthens our belief that our therapy should be used earlier in the tumor treatment paradigm. Speaking directly to the potential for Novocure beyond GBM, we continue to advance our clinical pipeline in five additional solid tumor indications with high unmet needs and significant market opportunities. We have patients enrolling in Phase III pivotal trials in non-small cell lung cancer and brain metastases from non-small cell lung cancer. We believe we can make a real impact in patient outcomes in both of these indications and they each comprise market opportunities that are 10 times larger than GBM. In December, we received FDA IDE approval to initiate our third Phase III clinical trial, our PANOVA 3 trial. PANOVA 3 will study Tumor Treating Fields with nab-paclitaxel and gemcitabine as the front-line treatment for unresectable, locally-advanced pancreatic cancer. Pancreatic cancer with a growing incidence was the third leading cause of cancer death in the US in 2017. Nearly all…

Thank you, Bill. And good morning, everyone. We delivered record revenue of $53.7 million in the fourth quarter of 2017, growing 77% year-over-year and 7% quarter-over-quarter. For the full year, we delivered $177 million in net revenues, representing 114% growth year-over-year. Revenue growth was driven both by increased Optune adoption and by an increase in net revenues per patient. The increase in net revenues per patient was primarily driven by an increase in positive coverage policies in the United States and improving reimbursement approval rates in Germany. In 2018, with the implementation of the new ASC 606 revenue recognition standard, we estimate that global net revenues per patient will be approximately 45% of gross billings. We are engaged in active dialogues with government payers in the United States, Germany, Switzerland and Israel and expect that any anybody positive reimbursement decision resulting from these discussions will be the next likely trigger to drive a significant improvement in net revenues per patient. We recognize that everyone on the call is eager for an update on Medicare discussions. We continue to engage in active discussions with the CMS administration regarding Medicare reimbursement for Optune. The discussion currently focuses on ensuring Medicare appropriately prices the billing code for Optune under its existing rules. We plan to request Medicare coverage for Optune after we clearly understand how CMS and Medicare intend to calculate pricing. Medicare does not have a defined timeline for this process and we're unable to predict when the discussions will come to a resolution. As a reminder, we continue to treat Medicare patients, representing 20% to 25% of the US patient population, although we have not yet received any material payments from Medicare. Gross profit in the quarter was $38 million or 71% of net revenues compared to $19.3 million or 64%…

Thank you. [Operator Instructions]. Our first question comes from Gregg Gilbert with Deutsche Bank. You may begin.

Thank you, team. I have a few. First, Wilco, can you help us with operating expenses, R&D and SG&A for the year and talk about how this may phase through the quarters? And can you talk about Japan penetration, if there's been any since the end of the year given the approval there?

Good morning, Gregg. Let's start with the second one, Japan penetration, because we're very excited about that opportunity. As you know, we received approval in December 2017 for reimbursement. We then started the process of organizing ourselves in terms of contracting with hospitals because there the supply chain goes through hospitals and putting patients on treatment. As you'll recall from prior calls, we already made significant steps prior to the reimbursement decision. We had 163 certified centers and strong support from JSNO in Japan. We recruited the first patients on treatment and we actually received initial payments – one of those [ph] first payments in January. So, we're very pleased with where we are in Japan. With respect to operating expenses, I think I said it in the prepared remarks. Our SG&A increased by about 11% for the full year, but we doubled our revenue. As you will recall, we are totally committed to succeeding in improving our operating leverage as one of our core objectives. The other two clearly are commercializing of GBM and running our clinical pipeline effectively. That has not changed significantly. We continue to be committed to improving our operating leverage. But as I said, we do expect that R&D expenses will go up a little bit with enrollment of the now Phase III trials that we're enrolling.

And then, just two quick ones, if I could. Can you share when there are interim looks for your ongoing Phase III studies? And on Medicare, I assume you've come to some agreement on pricing. How should we think about to what degree that would affect pricing in the commercial business, if at all?

Yeah. Let's talk about the second. And Eilon is on the call. We're very fortunate. He'll take the first part of the question. Medicare, I think we tried to explain it on the call that the discussion is focusing on pricing. We don't know what the price ultimately will be or what the timeline is since there is no fixed protocol for that. There is a pricing mechanism that is available to CMS. We're focused on that. It's very difficult to predict where we ultimately will land, but it's one of the parameters where we believe that 45% net revenue or gross revenue could improve significantly. Maybe a few words from you, Bill, on this?

Sure. Again, one the hand, you'll recall we continue to treat all of the Medicare patients for which we receive prescriptions. It's consistently represented between 20% and 25% of our US business. 20% and 25% of our US business. The discussions, as Wilco mentioned, are now focused on pricing. We are conducting them at the highest levels of CMS in Washington. So, we're not having the discussions at the remote site. We continue to benefit from significant support among both sides of the aisle on Capitol Hill, as well as the whole variety of brain tumor advocacy groups. It's frustrating that there's not a timeline, but we feel as if the discussions are extremely constructive at this point.

Before we get to the pipeline question, I'm sorry I have to just interject. The question was more about would you expect the pricing, whatever it is, to affect your existing pricing in commercial business? Thanks.

Right now, we do not.

Thank you.

Okay. Regarding interim analyses, so, first of all, the brain metastases METIS trial where we're treating patients after stereotactic radiosurgery with Tumor Treating Fields, it does not have an interim analysis plan. The two other Phase III studies, the PANOVA 3 and LUNAR studies, do have interim analyses plant. However, we don't disclose the exact timing of those analyses.

Thanks, guys.

Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. You may begin.

Good morning. Thanks for taking the question. So, I wanted to first start on the trends in GBM. So, by our math, the duration of therapy, it increased pretty significantly by about – I guess, year-over-year about 19% in our model. It was up significantly in Q4. And the percent of newly diagnosed was 66% globally, you said. I just wanted to ask about where you see those trending in 2018. And I'm asking because those are important drivers of patients on therapy and I had a couple of follow-ups.

Larry, good morning. As you know, we don't guide. However, it has been a consistent focus of our commercial organization to work with clinicians, so that they understand the benefits to patients when patients are treated from the time of diagnosis rather than waiting till recurrence. We are certainly pushing the trend. And as you noted, we saw significant movement over the course of last year. We don't think that will ever get quite to 100% because patients will continue to enter clinical trials that may or may not contain Optune and, for various other reasons, they may choose to weight. But we continue to believe that the majority, in fact, the vast majority of patients, should start at the time of diagnosis.

And I wanted to ask about the prescription growth as well. So, you guys – I don't understand the strategy is to shift more prescriptions to newly diagnosed from recurrent, and that's clearly working. But prescriptions in the US have been relatively flat the past three quarters. I did hear Asaf's comments about patients on therapy. They've been growing faster than prescriptions. But I was hoping – I know you don't guide, but I was hoping you could set some expectations for prescriptions in Q1 and 2018, so we don't have a disconnect between your strategic focus on driving that shift to newly diagnosed versus consensus, which has prescription growth up, I think, 10% sequentially in the US in Q1 and 21% year-over-year in 2018 in the US. Would you expect growth in prescriptions in the US in 2018? And if so, what drives that versus what we've seen over the past three quarters? And I did have one follow-up.

So, as you said, we're not guiding whether we are – continue to increase the penetration in the US and other markets. And we expect to continue to – we expect to continue to grow patient on treatment, which means that in order to increase patient on treatment, you need to increase prescription as well.

Okay, fair enough. And then, just on mesothelioma, my question is basically where – when do you plan on disclosing the data and maybe some preliminary thoughts on median overall survival? What do you think you need to show to be successful commercially? Thanks for taking the questions.

Sure. I'll be happy to answer that. So, first of all, as we've said, we're expecting to have data mid-2018 from the STELLAR trial following the follow-up period on the trial and collecting all of the data. If the data is consistent with what have seen in the past, we expect that should be enough for us to submit to regulatory authorities to attempt to get approval for mesothelioma. As you remember, we have a humanitarian use designation for mesothelioma, which opens the path actually to submit an HDE, humanitarian device exemption in the US. If we get that, that would enable us to commercialize in mesothelioma.

Okay. But no comment on what you think the median overall survival you'd need to show because I don't think you showed median overall survival in the original 40 patients? That's it for me and I'll drop. Thanks.

Thank you.

Thank you. Our next question comes from Difei Yang with Mizuho Securities. You may begin.

Good morning. Thank you for taking my questions. So, a quick one. Wilco, could you talk about the dynamics involved in gross to net that, I think, is slightly going down from upper 40s to what you just guided, 45%. What's going on? What might be going on there?

Good morning. And thanks for the question. As we said in prior quarters, in the third quarter of – especially in the third quarter of 2017, I think we discussed that under the old accounting revenue recognition instruction, we moved – we were able to certain patient-payer relationship from cash-based revenue recognition to accrual-based revenue recognition. What we disclosed after the third quarter was that, on an apples-to-apples basis, we estimated that the gross to net, without those adjustments, was approximately 46%. And with that, it was at 49%, as we showed in the third quarter, most favorably impacted by this one-time bump from certain receivables being moved from cash-based rev rec to accrual-based rev rec. So, it was about 40% to 46%. The 45% that we now estimate, 2018, will show it's more a mix effect than anything else. So, the gross to net has been substantially where we are now. We're working very hard on proving it through improved collection and things like that. But as we've said during the call, the significant impact will be a national reimbursement decision from, for instance, Medicare that we talked about earlier on. But we're also working on Germany, Israel and Switzerland.

Okay, got it. Thank you. So, just a quick follow-up. Would you say the conversion from cash-based accounting to accrual method has been completed or basically done?

Yes, it's completed for the mere reason also that there's a new accounting instruction out 606 that we referenced as well. That's been applicable as of 01/01/18 and that essentially eliminates cash to accrual adjustments going forward.

Okay. And then, another quick question on the scientific side. So, do you see when we move from GBM to other parts of either same or when we move from one side to the other, do you see more complications or less complications?

I'll take that question. This is Eilon. So, the basic mechanism of action of Tumor Treating Fields is pretty ubiquitous. We see it in all the different cell types that we've treated pre-clinically. We don't expect the mechanism to be, in any way, different in other parts of the body, which is also the advantage because we think we can – it's our expectation somewhat in future tumor types based on our experience with the ones we've treated today. And so, we're not expecting any difference in the mechanism. Regarding safety, or possible toxicities, there's always the possibility that there will be new toxicities discovered in clinical testing. However, we have not seen that to date. We have not seen any systemic toxicities in any of our Phase II studies, the pilot studies in pancreas, ovarian, we haven't seen it in mesothelioma to date. And so, we're not expecting any change in the risk-benefit profile of the therapy.

Okay, thank you. And then, just a quick follow-up on the location of the tumor in the TT field. How important is that geographic location in the field? Or maybe it's not a factor at all.

It definitely is a factor, the location, which is why we simulate and plan field distributions in order to optimize the intensity of the fields within the tumor, wherever it is in the body. You remember that for glioblastoma, we have a planning software which is used by physicians to plan the array locations on the head, which allows them to optimize the therapy for each patient.

Okay, thank you for the explanation.

[Operator Instructions]. Our next question comes from Cory Kasimov with J.P. Morgan. You may begin.

Hey, guys. This is Shawn on for Cory. Thanks for taking my question. And congrats on the progress this year. Just wondering, any chance that you guys will be providing updated data from either the PANOVA 2 or the INNOVATE trial? And is the plan to maybe publish those data in journals at some point? Just thinking, since we've yet to see them [indiscernible] from cohort 2 and PANOVA 2 or from INNOVATE.

So, we're not planning on updating the data from PANOVA 2 or INNOVATE. We are in the process of getting the data published in peer-reviewed journals.

Okay. And at some point, as your revenues continue to ramp and pickup ex-US, will you maybe at some point begin to break out your US and your ex-US sales as opposed to just prescriptions and active patients by geography?

I think we already do, Shawn. So, we break out active patients. We even break down Germany in the European and EMEA section. Maybe the question is later on, whether we have further disclosure, section disclosure, I think that's way ahead of where we are now. So, I think we feel comfortable with the way we disclose currently, the geographic aspects of our business. But happy to talk to you about that if you have any questions.

Okay, great. And last question for me. As you guys order get more experienced with the various EU markets and as reimbursement in these locales start to come online, what would – I guess come further online, what would prompt you or what would be the impetus for you to consider entering other markets in Europe?

Our focus this year is to penetrate the markets in which we're already present. We'll, of course, be opportunistic with respect to other markets, but I think, for 2018, the expectation we'd like to set is that we're very active in the new markets. We've talked about Japan. We've talk about Israel, Switzerland and Austria. We have a long way to go in Germany and the US. And that is the commercial focus for GBM in the coming year.

Okay. Great, guys. Thanks again.

Thank you. Our next question comes from Mike King with JMP Securities. You may begin.

Good morning, guys. Thanks for taking my question. First is a bit of a follow-up from the previous questioner just as far as publication strategy is concerned, if you might be able to expand upon what might hit the peer-reviewed literature in 2018. And I'm particularly interested if any of that data could support NCCN guideline adoption in for other tumor types?

Thanks. That's an excellent question. Right now, as you know, we just published the final results of the year 14 trial in JAMA in December; and actually, 1st of February, the full quality-of-life data from the same trial in JAMA Oncology. Those already, I think, are significant factors which we believe should support the NCCN rethinking maybe the GBM guideline. In addition, we are publishing, as I said, the pilot data from our ovarian and our pancreatic trials. Those should be published during this year. Again, you can never know exactly what publication. There is always a back-and-forth. Other significant data sets will depend on the data developed during the year. There will likely be preclinical publications. I do not see, at this point, any of this data actually driving NCCN guidelines in other indications.

Okay, thanks for the clarity there. And then, a lot of my other questions have been answered. But one commercial question about Japan. And I don't know if you guys have dimensionalized that opportunity either in terms of number of patients and/or revenue opportunity for you for Optune. So, if you might give us a little color on that please.

Yeah. Thank you for your question. So, the number of cases in Japan, GBM cases, is 1,500 patients a year. And besides, we're not guiding about any other numbers besides the fact that we already train 153 centers and we're actually working to contract hospitals in order to start [indiscernible].

Would you say there's anything culturally about that market that might be more or less favorable to Optune adoption?

I think it's too early. We certainly are very pleased by the fact that we're, as far as we know, the only therapy to be approved in Japan without the requirement of a Japanese bridging trial. We have tremendous support from JSNO, which is the Japanese Society of Neuro-Oncology, and that's the reason we were successful with both the regulatory approval and the reimbursement approval. But exactly how that translates into the commercial business, of course, we will learn as we go.

Right. Yeah, I'm just asking because I know, historically, that patient population has been fairly adverse to toxic or even highly – therapies that have a lot of side effects. So, it would seem Optune is well-suited to that market. All right. Thanks, guys. Appreciate it.

Thanks very much.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to management for closing remarks.

So, again, I'd like to thank everyone for their interest in Novocure. When I look back over 2017, it was a year of tremendous progress across our three primary objectives. We made significant progress in helping patients with GBM worldwide. We made significant progress in advancing our pipeline and other solid tumor cancers. And as Wilco mentioned, we made significant progress in achieving the leverage financially to allow us to develop both our GBM business and our pipeline without the prospect of future dilution. So, thank you all.

Ladies and gentlemen, this concludes today's conference. Thanks for your participation and have a wonderful day.