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Edited Transcript of NVCR earnings conference call or presentation 22-Feb-18 1:00pm GMT

Thomson Reuters StreetEvents

Q4 2017 Novocure Ltd Earnings Call

SAINT HELIER Mar 8, 2018 (Thomson StreetEvents) -- Edited Transcript of Novocure Ltd earnings conference call or presentation Thursday, February 22, 2018 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Asaf Danziger

NovoCure Limited - CEO & Director

* Ashley Cordova

* Eilon Kirson

NovoCure Limited - Chief Science Officer and Head of Research & Development

* Wilhelmus C. M. Groenhuysen

NovoCure Limited - CFO

* William F. Doyle

NovoCure Limited - Executive Chairman

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Conference Call Participants

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* Shawn Fu

JP Morgan Chase & Co, Research Division - Analyst

* Difei Yang

Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research

* Gregory B. Gilbert

Deutsche Bank AG, Research Division - MD and Senior Analyst

* Lawrence H. Biegelsen

Wells Fargo Securities, LLC, Research Division - Senior Analyst

* Michael George King

JMP Securities LLC, Research Division - MD and Senior Research Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to Novocure Fourth Quarter 2017 Earnings Results Conference Call. (Operator Instructions)

As a reminder, this conference call is being recorded. I'd now like to turn the conference over to Ashley Cordova, Vice President, Finance and Investor Relations. Ma'am, you may begin.

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Ashley Cordova, [2]

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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 statements, 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 3 months and year-ended December 31, 2017, are available in our press release and our 10-K, both of which were released earlier this morning.

With that, I will now turn the call over to Bill Doyle.

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William F. Doyle, NovoCure Limited - Executive Chairman [3]

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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 are 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 tuned to 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 5-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 anticancer 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 of 2017. Asaf?

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Asaf Danziger, NovoCure Limited - CEO & Director [4]

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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 EF-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 a 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 a global penetration rate of 22% in our currently active markets. Our first commercial priority in any market is to generate awareness of Optune and of our unprecedented 5-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 U.S. 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 prescriptions. Once awareness is established, our commercial priorities shift to increasing physician confidence and belief in Optune as a standard treatment for GBM.

We believe that the strength of a physicians' recommendation for use of Optune closely correlates with the percentage of patients who start therapy with Optune. We achieved 2 key milestones in the fourth quarter of 2017, which supports our long-term survival messaging and which should increase physician confidence in Optune.

First, we presented data from a post-hoc analysis of our EF-14 trial in November that showed a clear dose response to Optune. Increased Optune compliance predicted increased survival in GBM patients. Patients who used Optune more than 90% of the time had a 5-year overall survival rate of 29.3% compared to 5% for patients treated with temozolomide alone.

Second, JAMA published the final analysis of our EF-14 trial in December. We believe the peer-reviewed publication of our Phase III pivotal trial in JAMA will increase the feasibility of our unprecedented 5-year survival results within the medical community. In addition to working towards growing commercial adoption in the U.S. and Germany, we also extended the market for Optune to Japan. We received a national reimbursement decision in Japan for the treatment of newly diagnosed GBM in December 2017. Japan is the largest market in which we have received public reimbursement to date.

Ahead of reimbursement, we began to certify centers in Japan and had 163 certified centers as of December 31, 2017. In 2018, we plan to continue to build our commercial infrastructure in Japan and have begun to put patients on therapy.

With that, I will turn the call back to Bill to review our progress in R&D.

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William F. Doyle, NovoCure Limited - Executive Chairman [5]

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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 anti-neoplastic treatment pathway, by which Tumor Treating Fields potentiate 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 5 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 pivotal trial, our PANOVA 3 trial. PANOVA 3 will study Tumor Treating Fields with nab-paclitaxel and gemcitabine as a frontline treatment for un-resectable locally advanced pancreatic cancer. Pancreatic cancer, with a growing incidence, was the third leading cause of cancer death in the U.S. in 2017. Nearly all patients with locally advanced pancreatic cancer are diagnosed when the tumors are no longer resectable and treatment advances are desperately needed to improve survival outcomes.

In our Phase II pilot trial of Tumor Treating Fields plus nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer, both locally advanced and metastatic disease, the addition of Tumor Treating Fields more than doubled progression free survival and the 1-year survival rate compared to historical controls.

With the FDA IDE approval in hand, we are working closely with trial sites and institutional review boards to open sites and enroll patients as quickly as possible.

Our next clinical data readout will be in mesothelioma - the lung cancer associated with asbestos exposure. Thankfully, this is a relatively low-incidence cancer in the United States although in other parts of the world, the incidence is still growing. The prognosis for mesothelioma patients is very poor, with the median overall survival of approximately 12 months in most reported studies. We enrolled the last patient in our Phase II pilot trial in mesothelioma, the STELLAR trial, in March 2017. There is a minimum 12 months follow-up following the last patient enrollment and we anticipate final data collection in mid-2018.

Earlier in 2017, we received Humanitarian Use Device designation for the use of Tumor Treating Fields for the treatment of pleural mesothelioma, which opens up the possibility to apply for registration based on strong Phase II pilot data. Assuming the final data readout from our STELLAR trial is consistent with the interim analysis, we anticipate filing an HDE application for approval in mesothelioma with our STELLAR data. An approved HDE would allow us to market Tumor Treating Fields in combination with standard-of-care chemotherapy as a treatment for pleural mesothelioma in the United States.

With that clinical summary, I will now hand the call over to Wilco to review our financials.

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [6]

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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, the estimated 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 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 U.S. 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% of net revenues for the same quarter last year. The improved margin was driven both by improved net revenues as a percentage of gross billings and by the ongoing efforts to reduce our cost of revenues with efficiency initiatives and scale.

Moving down the income statement, our R&D expenses were $10 million for the fourth quarter of 2017 compared to $8.5 million for the same period last year. We anticipate that R&D expenses will increase in future quarters as we continue to enroll patients in Phase III pivotal trials. We are committed to funding research and development activities to advance our clinical pipeline and realize the full value of our technology across multiple solid tumor indications.

Our SG&A expenses for the quarter were $32.5 million compared to $28.7 million for the same period last year. For the full year 2017, SG&A expenses were $122.6 million compared to $110.5 million for the same period in 2016. This represents 114% growth in revenue 2017 versus 2016 with only 11% growth in SG&A expenses. Driving operating leverage in our commercial business has been a core strategic objective of ours in 2017 and we continue to see the results of these efforts.

Our fourth quarter 2017 operating loss was $4.5 million compared to an operating loss of $17.9 million for the same period last year. It is important to note that our fourth quarter 2017 operating loss includes $6.4 million in noncash, share-based compensation to employees.

Net loss for the fourth quarter 2017 was $10.9 million, or $0.12 per share, compared to a net loss of $22.2 million, or $0.26 per share, for the same period last year.

Our ongoing focus on leveraging our existing infrastructure has resulted in significant year-over-year reduction in cash burn. At December 31, 2017, we had a total of $183.3 million in cash, cash equivalents and short-term investments on our balance sheet. Importantly, our GBM business has begun to fund pipeline. We are committed to funding research and development activities to advance our clinical pipeline and anticipate these expenses will increase in future quarters as we continue to enroll patients in Phase III pivotal trials.

In February 2018, we further strengthened our cash position when we entered into a new $150 million term loan agreement with an investment fund managed by Pharmakon Advisors, LP. Proceeds of this term loan were used to pay in full Novocure's existing $100 million term loan debt and to fund working capital. For this transaction, we significantly improved the maturity profile of our debt, which now extends to February 2023. There are no explicit financial covenants, so the funds will be available to us during the term of the loan.

Lastly, but not unimportantly, we reduced the cost of capital. Demonstrating our commitment to non-dilutive capital, we believe this new credit facility significantly reduces the risk that additional capital will be needed to fund our company. The agreement provides us with the financial stability and flexibility to continue to execute our core strategies with the support of a strong balance sheet.

Novocure is a global oncology company with a proprietary platform technology, a growing commercial business and a significant upside potential. We are focused on 2 clear priorities. First, drive commercial adoption of Optune. Second, advance our clinical pipeline to include a range of solid tumor cancers where we think Tumor Treating Fields can help patients. We believe we enter 2018 well positioned to execute on both fronts.

With this, I'll open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Gregg Gilbert with Deutsche Bank.

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Gregory B. Gilbert, Deutsche Bank AG, Research Division - MD and Senior Analyst [2]

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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 those may phase through the quarters? And can you talk about Japan penetration, if there has been any since the end of the year given the approval there?

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [3]

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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 to process of organizing ourselves in terms of contracting with hospitals because there the supply chain goes through hospitals in putting patients on treatment. As you 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 put the first patients on treatment and we actually received our 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 2 are clearly our commercializing of GBM and running of 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 3 Phase III trials that we're enrolling.

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Gregory B. Gilbert, Deutsche Bank AG, Research Division - MD and Senior Analyst [4]

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Okay. And then just 2 quick ones, if I could. Can you share when there are interim looks for your ongoing Phase III studies? And on Medicare, assuming you 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?

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [5]

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Yes. Let's start with the second and Eilon is on the call - we're very fortunate - and he will 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 that price ultimate 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 of gross revenue could improve significantly. Maybe a few words from you, Bill, on this?

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William F. Doyle, NovoCure Limited - Executive Chairman [6]

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Sure. Again, on one hand, you 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 U.S. 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 sites. We continue to benefit from significant support on both sides of the aisle on Capitol Hill as well as a whole variety of brain tumor advocacy groups. It's frustrating that there is not a timeline, but we feel as if the discussions are extremely constructive at this point.

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Gregory B. Gilbert, Deutsche Bank AG, Research Division - MD and Senior Analyst [7]

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

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [8]

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Right now, we do not.

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [9]

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Okay. Regarding interim analysis. First of all, the brain metastases, METIS trial, where we're treating patients after stereotactic radio surgery with Tumor Treating Fields, does not have an interim analysis planned. The 2 other Phase III studies, the PANOVA 3 and LUNAR studies, do have interim analysis planned. However, we don't disclose the exact timing of those analyses.

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Operator [10]

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Our next question comes from Larry Biegelsen with Wells Fargo.

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Lawrence H. Biegelsen, Wells Fargo Securities, LLC, Research Division - Senior Analyst [11]

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I wanted to first start on the trends in GBM. So by our math, the duration of therapy has increased pretty significantly by about 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. So 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.

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William F. Doyle, NovoCure Limited - Executive Chairman [12]

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So, 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 until recurrence. We are certainly pushing the trend. And as you noted, we saw a significant movement over the course of last year. We don't think that will ever get quite to a 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 wait. But we continue to believe that the majority, in fact, the vast majority of patients should start at the time of diagnosis.

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Lawrence H. Biegelsen, Wells Fargo Securities, LLC, Research Division - Senior Analyst [13]

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And I wanted to ask about the prescription growth as well. I understand the strategy is to shift more prescriptions to newly diagnosed from recurrent and that's clearly working. But prescriptions in the U.S. have been relatively flat the past 3 quarters. I did hear Asaf's comments about patients on therapy that have been growing faster than prescriptions. 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 U.S. in Q1 and 21% year-over-year in 2018 in the U.S. Would you expect growth in prescriptions in the U.S. in 2018? And, if so, what drives that versus what we've seen over the past 3 quarters? And actually I have one follow-up.

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Asaf Danziger, NovoCure Limited - CEO & Director [14]

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So as you said, we have not guided. However, we continue to increase the penetration in the U.S. and other markets. And 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.

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Lawrence H. Biegelsen, Wells Fargo Securities, LLC, Research Division - Senior Analyst [15]

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Okay. Fair enough. And then just on mesothelioma. When do you plan on disclosing that data? And maybe some preliminary thoughts on median overall survival? What do you think you need to show to be successful commercially?

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [16]

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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 the data. If the data is consistent with what we 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 U.S. If we get that, that would enable us to commercialize in mesothelioma.

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Lawrence H. Biegelsen, Wells Fargo Securities, LLC, Research Division - Senior Analyst [17]

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Okay. But no comment on what you think the median overall survival you 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.

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Operator [18]

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Our next question comes from Difei Yang with Mizuho Securities.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [19]

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Wilco, could you talk about the dynamics involved in gross to net? I think it's slightly going down from upper 40s to what you just guided to of 45%. What might be going on there?

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [20]

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Good morning, and thanks for the question. As we said in prior quarters, in third quarter of '17, we discussed that under the old accounting revenue recognition instruction, we were able to move certain patient-payer relationships from cash-based revenue recognition to accrual-based revenue recognition. And 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, that was at 49% that we showed in the third quarter was 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 46%. The 45% that we now estimate 2018 will show is more a mix effect than anything else. So the growth in that 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 said during the call, the significant impact will be national reimbursement decisions from, for instance, Medicare that we talked about earlier on, but we're also working on Germany, Israel and Switzerland.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [21]

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Okay. Got it. Just a quick follow-up - would you say the conversion from cash-based accounting to accrual method had been completed or is basically done?

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [22]

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Yes, it's completed. For the mere reason also that there's a new accounting instruction out, ASC 606, that we referenced as well, that's been applicable as of 1/1/18. And that essentially eliminates cash to accrual adjustments going forward.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [23]

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Okay. Then another quick question on the scientific side. Do you see when we move from GBM to other parts of the body that the mechanism of action is basically the same? Or when we move from one side to the other, do you see more complications or less complications?

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [24]

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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 preclinically. 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 base our expectations somewhat on future tumor types based on our experience with the ones we have treated to date. And so we're not expecting any difference in the mechanism. Regarding safety or possible toxicities, there is always the possibility that there would be new toxicities discovered in clinical testing. However, we have not seen that to date. We have not seen anything systematic 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.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [25]

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Okay. And then just a quick follow-up on the location of the tumor with respect to the TTFields. How important is that geographic location in the field or maybe it's not a factor at all?

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [26]

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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'll remember that for glioblastoma, we have 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.

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Operator [27]

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(Operator Instructions) Our next question comes from Cory Kasimov with JP Morgan.

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Shawn Fu, JP Morgan Chase & Co, Research Division - Analyst [28]

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This is Shawn on for Cory. Just wondering, any chance that you guys will be providing updated data from either the PANOVA 2 or the INNOVATE trials? And is the plan to maybe publish those data in journals at some point? Just thinking, since we've yet to see the mature median overall survival (OS) data from cohort 2 and PANOVA 2 or from INNOVATE?

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [29]

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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.

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Shawn Fu, JP Morgan Chase & Co, Research Division - Analyst [30]

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

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Wilhelmus C. M. Groenhuysen, NovoCure Limited - CFO [31]

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I think we already do, Shawn. We break out active patients per geography. We even break down Germany in the 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. But 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 questions.

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Shawn Fu, JP Morgan Chase & Co, Research Division - Analyst [32]

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

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William F. Doyle, NovoCure Limited - Executive Chairman [33]

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Yes. So 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 talked about Israel, Switzerland and Austria. We have a long way to go in Germany and U.S. And that is the commercial focus for GBM in the coming year.

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Operator [34]

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Our next question comes from Mike King with JMP Securities.

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Michael George King, JMP Securities LLC, Research Division - MD and Senior Research Analyst [35]

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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 for other tumor types?

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Eilon Kirson, NovoCure Limited - Chief Science Officer and Head of Research & Development [36]

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Thanks. That's an excellent question. Right now, we, as you know, just published the final results of the EF-14 trial in December. And, actually on the 1st of February, we also published 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 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's 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.

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Michael George King, JMP Securities LLC, Research Division - MD and Senior Research Analyst [37]

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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 opportunities for you for Optune? So if you might give us a little color on that, please.

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Asaf Danziger, NovoCure Limited - CEO & Director [38]

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Yes. Thank you for the question. So the number of cases in Japan, GBM cases, is 1,500 patients a year. And besides that, we're not guiding about any other numbers beside the fact that we already train 163 centers and we actually are working to contract hospitals in order to start the first patients on treatment there.

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Michael George King, JMP Securities LLC, Research Division - MD and Senior Research Analyst [39]

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

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William F. Doyle, NovoCure Limited - Executive Chairman [40]

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Yes. I think it's too early to tell. 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.

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Michael George King, JMP Securities LLC, Research Division - MD and Senior Research Analyst [41]

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Right. Yes, I'm just asking because I know, historically, that patient population has been fairly averse to toxic or to therapies that have a lot of side effects. So it would seem that Optune is well-suited to that market.

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Operator [42]

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

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William F. Doyle, NovoCure Limited - Executive Chairman [43]

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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 3 primary objectives. We made significant progress in helping patients with GBM worldwide. We made significant progress in advancing our pipeline in 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.

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Operator [44]

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