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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2016 - Q3
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Executives

Ashley Cordova - Vice President of Finance and Investor Relations William Doyle - Executive Chairman Asaf Danziger - Chief Executive Officer Wilco Groenhuysen - Chief Financial Officer.

Analysts

Cory Kasimov - JPMorgan Chase & Co. Michael King - JMP Securities Lawrence Biegelsen - Wells Fargo Securities Tao Levy - Wedbush Securities, Inc. Volodymyr Nikolenko - Evercore ISI.

Operator

Good day, ladies and gentlemen, and welcome to the Novocure Third Quarter 2016 Earnings Results Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this conference is being recorded.

I would now like to hand the conference over to Ashley Cordova, Vice President of Finance and Investor Relations. Please go ahead..

Ashley Cordova Chief Financial Officer

Good morning everyone, and thank you for joining us to review Novocure’s third quarter 2016 performance. I’m joined today by our Executive Chairman, William 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 homepage, www.novocure.com by clicking on the link for 2016 third quarter financial results, located in the Events & Presentation section in the lower middle column of the Investors page.

Before we start, I’d like to remind you that our discussions in 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 some brief prepared remarks and then we’ll move to a question-and-answer session. I will remind everyone that our financials for the three and nine months ended September 30, 2016 are available on our press release and in our 10-Q, both of which were released earlier this morning.

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

William Doyle Executive Chairman

Thank you, Ashley, and good morning, everyone. Before we jump into the details of the quarter, I want to remind everyone of Novocure’s simple two-pronged strategy. We are focused on transforming the standard of care for glioblastoma to include treatment with Optune.

And we are committed to developing TTFields for the treatment of a variety of other solid tumors. We made good progress on both fronts in the third quarter. We saw year-over-year in sequential growth in the third quarter across all key operating statics and in revenues.

We finished the quarter with 690 prescriptions, representing 94% growth compared to the third quarter 2015, and 5% growth compared to Q2 2016.

As of today, we have also negotiated contracts to establish Optune as an in-network benefit for more than 120 million lives, including agreements with two of the three largest health plans in the United States, to become effective during Q4 2016.

In September, we announced that the long-term analysis of our phase 3 pivotal trail in newly diagnosed GBM confirms the superior progression-free survival and overall survival seen at the interim analysis.

The long-term analysis showed survival rates were significantly higher, two, three and four years from randomization in patients receiving Optune with temozolomide compared to temozolomide alone.

A number of clinicians have voiced their desire to see these long-term data to be presented as a late breaking oral presentation at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology on November 18.

Optune plus temozolomide is the first treatment in more than a decade to significantly improve outcomes for patients with newly diagnosed GBM. Importantly, treatment with Optune does not harm newly diagnosed patients’ quality of life, cognitive and functional capabilities or ability to perform functions of daily living.

And our EF-14 trial, Optune extended survival for patients with newly diagnosed glioblastoma, and it’s transforming the way that glioblastoma is treated. I will now hand the call over to Asaf for a bit more color..

Asaf Danziger Chief Executive Officer & Director

Thank you, Bill, and good morning, everyone. We had 690 prescriptions in the third quarter including 569 prescriptions in the U.S., and 120 prescriptions in Germany, Switzerland and other EMEA markets. This represents 4% quarter-over-quarter growth in the U.S. and 9% quarter-over-quarter growth in the EMEA. The sequential growth in the U.S.

was mainly driven by increased adoption from radiation oncologists. This group has been a core target of our sales and marketing efforts since our launch in newly diagnosed GBM. More than 50% of our prescriptions in the third quarter were from patients with newly diagnosed GBM.

The prescription fill rate for the 12 months ended September 30, 2016 was 74%. We continue to work towards wide acceptance for Optune by both clinicians and patients. Clinicians continue to gain experience with Optune. Clinicians are also gaining the experience with how to present the treatment to their patients.

Treatment with Optune is the most significant advance in newly diagnosed GBM in more than a decade. Treatment with TTFields has the potential to impact the survival outcomes for patients with many types of solid tumors. Given what is at stake, we are relentless in our efforts to increase awareness, earn acceptance and drive adoption.

We show increased third-party validation of the value of treatment with TTFields during the third quarter. NCCN guidelines were updated in July. Including in treatment guidelines is important in our outreach to community-based oncologists. It also facilitates our efforts to include patients treated with Optune in clinical trials.

In fact, in the third quarter the Alliance valproate study was updated to specifically include Optune as a part of their visibility criteria. This NCI study is testing AbbVie’s PARP inhibitor in combination with temozolomide in newly diagnosed GBM.

Before I handed over to Wilco to talk about the financials, I want to take a moment to thank all of our colleagues worked so hard on the launch of the second generation Optune System. The second generation Optune System is less than half the weight and size of the first generation and it’s designed for everyday life for our patients.

We received FDA approval for the system in July, and we are fully prepared for the transition. The first patient was converted one week after FDA approval and 90% of the U.S. patients were converted within one month. Our colleagues who worked so hard on this transition exemplify our patient-forward mission.

With that, I will hand the call over to Wilco..

Wilco Groenhuysen

Thank you, Asaf, and good morning, everyone. There were 985 active patients on Optune therapy as of September 30, 2016, an increase of 516 patients or 110% compared to September 30, 2015 and an increase of 94 patients or 11% compared to June 30, 2016.

The increase in active patients was driven both by prescription growth and by an increase in the percentage of newly diagnosed GBM patients, who started Optune in prior periods and who typically have a longer duration of therapy.

We continue to expand coverage of Optune for the treatment of newly diagnosed and/or recurrent GBM in third quarter of 2016. More than 14 million additional lives are now covered through new policies with Medi-Cal, Premera Blue Cross and Geisinger Health Plan.

This brought the total number of covered lives to approximately 130 million in the United States as of September 30, 2016. Importantly, we have also made significant progress in contracting.

As of today, we have negotiated contracts to establish as Optune as an in-network benefit for more than 120 million lives, including agreements with two of the three largest health plans in United States to become effective during the fourth quarter 2016.

We anticipate that a significant increase in contracted lives will facilitate the transition to a accrual-based revenue recognition under U.S. GAAP for certain payers, as these contracts will enable us to reliably estimate the amounts that will ultimately be collected.

We will continue to recognize revenue on a cash basis for individual third-party payers with whom we do not have contracts and with whom we have not build up sufficient history to reliably estimate their individual payment balance.

We anticipate there will be an extended period of time when our revenue is a mix of both cash-based and accrual-based revenue. For the 12 months ended September 30, 2016, the average cash payments received continued to be more than $40,000 per charged month in the United States.

The difference between billed and paid amounts consists of patient financial assistance, charitable care, discounts, dispute of underpayments and indirect taxes. The payment amount metric does not include our experience with patients covered by the Medicare fee-for-service program, as we have not received material payments from that program.

These invoices remain open as we build the coverage denials to heavily backlogged ALJ controlled proceedings. The percentage of our U.S. active patient population who are beneficiary of the Medicare fee-for-service program continues to range between 20% and 25%.

The payment amount metric also does not include our experience outside of the United States, as we don’t get sufficient history of these payers to reliably report their payment better.

As we enter each new market, our commercial activities folks initially on establishing a required in-market infrastructure, certifying positions to prescribe Optune and obtaining a defined reimbursement pathway. Once established, our commercial efforts turn to increasing adoption of Optune within that market.

Now, I would like to highlight a few key points on our financial statements. Third quarter 2016 revenues increased to $21.7 million, compared to $9 million for the same period in 2015, representing 142% growth.

This growth was driven by increased demand for treatment with Optune after FDA approval of Optune for the treatment of newly diagnosed GBM in October 2015.

Global revenues included revenues outside of the United States of more than $3.5 million in the third quarter of 2016 versus $0.4 million in the third quarter of 2015, reflecting an increasing scale of our global operations and increased collection rates in Germany.

Net loss for the third quarter 2016 was $33.6 million, compared to $26 million for the same period in 2015. Our balance sheet remains strong.

As of September 30, 2016 we had $115.8 million in cash and cash equivalents and $119.7 million in short-term investments for a total balance of $235.5 million in cash, cash equivalents and short-term investments.

This balance includes net proceeds of $72.9 million received in July from a drawdown of funds available under our existing term loan agreement with an investment fund managed by Pharmakon Advisors, LP. Our third quarter net cash used in operating activities was $33.5 million.

In addition, we invested $4.8 million in PP&E and field equipment to support our commercial business. We believe our current cash and investment balances are sufficient to fund our operations for at least the next 12 months.

We remain committed to advancing TTFields and its approved indications as well as running a broad clinical development pipeline for additional indications.

Depending on the ultimate base of commercial adoption and the timing of our Phase 3 pivotal trials across multiple indications, we believe our current sources of liquidity should be sufficient to fund our operations through profitability. I will now turn the call back to Bill for some closing comments..

William Doyle Executive Chairman

Thank you, Wilco. Before we open the call to questions, I want to spend a few moments reviewing our clinical pipeline given its importance in the fundamental value of Novocure. The mechanism of action of TTField is broadly applicable for multiple solid tumors.

We have 15-plus years of research and multiple peer-reviewed publications with pre-clinical data in 14 indications. Pre-clinical evidence shows that the combination of TTFields with radiation and certain types of chemotherapy or immunotherapy may lead to additive or synergistic efficacy.

This includes recent preclinical data which suggest that TTFields together with certain immunotherapies such as PD-1 inhibitors might enhance tumor fighting effects. We have recently enrolled the first patient in our METIS phase 3 pivotal trial in brain metastases.

This multi-center open label study will test the effectiveness of TTFields following stereotactic radio surgery compared with watchful waiting alone in 270 patients with brain metastasis stemming from non-small cell lung cancer.

METIS is Novocure’s first Phase 3 pivotal trial outside of glioblastoma and represents a significant milestone for the company. We have developed the protocol for our LUNAR Phase 3 pivotal trial in non-small cell lung cancer and are in discussions with the FDA surrounding the IDE application.

As currently drafted, this multi-center open label study will test the effectiveness of TTFields in combination with PD-1 inhibitors or Docetaxel versus PD-1 inhibitors or Docetaxel alone for second line treatment of 512 patients with non-small cell lung cancer.

LUNAR builds on our Phase 2 pilot trial in 41 non-small cell lung cancer patients receiving TTFields in combination with Pemetrexed, published in lung cancer in July 2013, which showed a median progression-free survival that was more than double historical controls and a median overall survival that increased by more than 65% compared to historical controls.

We also have three ongoing phase 2 pilot trials in pancreatic cancer, ovarian cancer and mesothelioma.

The first cohort of our PANOVA Phase 2 pilot trial in 20 advanced pancreatic cancer patients receiving TTFields in combination with Gemcitabine presented at ASCO GI in January, showed median progression-free and overall survivals that were more than double historical controls.

We are excited to share an update of our full clinical pipeline including data on the second cohort of the PANOVA trial, and data from our INNOVATE phase 2 pilot trial in recurrent ovarian cancer at our R&D Day planned for December 12, 2016.

In closing, we are optimistic about the year-over-year and sequential growth that we see as we continue to work towards broad acceptance of Optune. Optune offers significant improvements in survival outcomes for patients with newly diagnosed glioblastoma, and it’s transforming the way that glioblastoma is treated.

We look forward to the presentation of our long-term GBM survival data SNO.

The broad applicability of TTFields across multiple solid tumor types, the potential compatibility of TTFields in combination with certain existing and novel therapies, and the potential of TTFields’ superior outcome with limited side effects gives us the confidence that this technology will play a valuable role in the solid tumor treatment paradigm.

With that, I’d like to thank everyone for their time this morning and for their interest in Novocure.

Operator, can we please poll for questions?.

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Cory Kasimov from JPMorgan..

Cory Kasimov

Hey, good morning, guys, and thanks for taking my questions. I guess, I first wanted to ask you about what seem like two very important developments in the third quarter, so the long-term data and the inclusion of Optune in treatment guidelines.

So first on the follow-up survival analysis, I’m curious how or when you think that may begin to benefit Optune commercially? Is there already some anecdotal feedback that it is having an effect or will take the upcoming presentation at SNO to drive the awareness or is this something that maybe we have to wait to be included in the label? Then, just curious on any tangible feedback you have on the significance of the inclusion in those treatment guidelines, since you do have roughly a full quarter since that took place.

Thanks..

William Doyle Executive Chairman

Yes, so good morning, Cory. Thanks very much for your questions. First of all, as you know, we don’t provide predictions of the future. But I think the two achievements that you mentioned are extremely important for Novocure and for GBM patients.

With respect to the long-term survival data, we are all looking forward to the presentation at the Society of Neuro-Oncology. As we have announced this will include data on, first of all, the full cohort of patients, everyone in the phone will recall that we received FDA approval on an expedited basis based on interim analysis.

However, at the time of the interim we had recruited the entire cohort and continue to follow that cohort. So the presentation at SNO will include data on the full 695-patient dataset, plus it will include the extended long-term analysis. And again, my expectation is that, that’s going to be extremely important for the GBM community as you know.

It’s extremely rare to be talking about three and four year survivals in this disease. With respect to NCCN, as we’ve discussed, we know that for newly diagnosed GBM, a significant portion of those patients, approximately 60% are treated in the community. And we believe that NCCN inclusion is extremely important, particularly in that area.

Asaf mentioned the increasing prescriptions from radiation oncologists. We think that the NCCN guidelines inclusion will continue to the benefit in the community and with rad-ons. And one of the things, I think we really saw in the third quarter as we reported is tremendous progress with payers, both in terms of covered and contracted lives.

This was a tremendous achievement. And I think that we can attribute much of that to the NCCN inclusion..

Cory Kasimov

Okay. And let me just go back to the question about the long-term survival, I guess to ask this is in a different way, in your second quarter call you talked about some of the headwinds or commercial hurdles that were in place. One of which was just there were some holdouts in the medical community who still, maybe didn’t necessarily fully given data.

So now that you have that long-term data you think would be pretty compelling to most physicians out there, and given how specialized of an [Technical Difficulty] in glioblastoma is in a conference like SNO.

So is there a precedent that physicians see the data at SNO and that is - it doesn’t have to be Optune necessarily, but for other products, that that’s what kind of drives adoption or is this more of a community where it’s got to be in the label for people to really respond to it?.

William Doyle Executive Chairman

Yes. I think our view is that the presentation of the data is the key event for this community. And that while over time the data will be submitted and likely included in the label. We think the presentation of the data is the key..

Cory Kasimov

Okay. That’s it. Well, thank you..

Operator

Thank you. And our next question comes from the line of Mike King from JMP Securities..

Michael King

Hey guys, sorry, I was on mute. I guess my questions really are a bit of a follow-up to Cory’s, which has to do with - I think you’ve talked about some of the elements of growth for the quarter.

But just wondering if you can attribute the success in the quarter, the sequential growth to any one particular factor or a multiple factors? I know in the second quarter it was rather challenging.

And I know that you also said with regard to the second quarter that it had to do with convincing physicians to prescribe it and getting patients to actually utilize the system.

So I’m just wondering if you can point to any key turnarounds, and was it more messaging, was it more feet on the street, anything in particular that you can point to?.

Asaf Danziger Chief Executive Officer & Director

Thank you for your questions. This is Asaf. So again, it’s not only one reason. We believe that the combination of the NCCN, the second generation, and the fact that that our prescriber base will change toward a rad-on community drove this growth.

And in addition, the fact that we are going to present the long-term survival in SNO, it also - I will say that that’s still another question mark on some of the skeptics. And I….

Michael King

Okay. Sorry, go ahead..

Asaf Danziger Chief Executive Officer & Director

No, no..

Michael King

Yes, I was just wondering, I was just looking at the slides in the appendix. And you have active patients on prior prescriptions in the period, prescriptions from the prior period sold. There is no comment about duration. And I’m not sure if you’ve got any reliable numbers at this point.

But can you talk a little bit about duration that you’re seeing and whether that increased on a quarter-to-quarter basis?.

Asaf Danziger Chief Executive Officer & Director

So the duration of therapy, basically it continue to be in line with our expectation..

Michael King

And you don’t want to get a figure on that number..

Asaf Danziger Chief Executive Officer & Director

So in the EF-14 trial, the median treatment duration was 8-point - I’m sorry, I’m sorry, so the median was nine months, and we continue to be in line with these numbers..

Michael King

Okay. But you also had a greater proportion of newly diagnosed patients in the quarter versus prior. So I’m just wondering if that’s helping you at all..

Asaf Danziger Chief Executive Officer & Director

Yes. Yes. I think that the mix is - over 50% of the patients are newly diagnosed, so you can make your conclusion..

Michael King

Right, okay, fair enough..

William Doyle Executive Chairman

Yes, but, Mike, just to jump in on this. I think we’re seeing consistency in terms of duration of therapy. So in the newly - in the recurrent population where we have a lot of experience, we continue to see approximately four months median. In the newly diagnosed, as Asaf mentioned in the clinical trial, we saw approximately nine months.

It’s too early in field because these patients live much longer to report a field base number. But we were comfortable that nine is a number that will stand - at least stand the test of time. And as also Asaf mentioned, we have seen our next shift.

We were at about 35% newly diagnosed in Q4, 2015, and we know that we’re now more than 50%, so there is some benefit to the continued shift to newly-diagnosed..

Michael King

Okay. Fair enough. Sorry to be a pest on that, and then just one quick noncommercial question. You guys talked about the phase 2s in pancreatic, lung and ovarian, just any update on the combinations with the checkpoint inhibitors and when we might see some data on those trials? Thank you..

William Doyle Executive Chairman

Yes. So first of all we - and thanks for the question, because we really want to emphasize that we are planning a comprehensive R&D Day for December 12. That will be held in New York. And at that R&D Day, we expect to share new clinical data both from our pancreatic cancer phase 2 and our ovarian cancer phase 2.

We’re also going to share the latest pre-clinical data that we have available. We’ll have an opportunity to really go in depth on the long-term analysis from SNO, because that will be by design after SNO.

And we’ll also have a chance to go into more detail about our phase 3 program and the trial design including, as Eilon mentioned in his comments, in our non-small cell lung trial design that does include immunotherapy..

Michael King

Thanks for the comprehensive answers, I appreciate it..

Operator

Thank you. And our next question comes from the line of Larry Biegelsen from Wells Fargo..

Lawrence Biegelsen

Good morning. Thanks for taking the question. Hopefully, you can hear me okay. Guys, let me just start with the news that your, in-network for 120 million people and two large health plans starting in Q4.

What are the implications of that?.

Wilco Groenhuysen

Larry, good morning. This is Wilco. I think the implications are multifaceted. We see it of course on the finance guys. So we see it as an important step towards shifting being able to shift to accrual-based revenue recognition. With these contracts we have certainty or enough certainty about the payment and payment rate.

So that’s the development that we expect to kick-in in the fourth quarter when some of these larger contracts become effective in the second-half of the fourth quarter. We also see it as a validation point. The larger payers are contracting. As you know, historically, we’ve had a very high success rate in securing reimbursements.

So we believe this is a confirmation of the consistency of that reimbursement and from a payer perspective the validation of TTFields as a treatment modality. It’s also beneficial from an efficiency perspective. We were still handling all those cases, both Novocure and those payers.

And we basically with the volume and with the data that both Bill and Asaf were alluding to, come to conclusion, does it make a whole lot of sense to spend a lot of time and energy on managing those claims. So again, from a reporting perspective important in the sense of enabling us to switch to the accrual based revenue recognition.

From a validation perspective, important that a very substantial proportion of the U.S. privately insured population is now under contract for TTFields. And from an efficiency perspective, we can deploy our resources on more meaningful efforts..

Lawrence Biegelsen

Thanks. That’s very helpful. And you continue to do well outside of the U.S. I think in the quarter about 17% of your prescriptions were from outside the U.S. How do you see that trending over time? And is there any update on Japan on newly diagnosed GBM? And I did have another question after that..

Asaf Danziger Chief Executive Officer & Director

So I will take the U.S. It’s mainly - we’re talking about the Europe, and basically Germany and Switzerland. And we are seeing a dramatic uptick. We build infrastructure over there to support all these patients and we have the field team to promote our treatment. And we are expecting to continue to see this growth in Europe.

Regarding Japan, we’re expecting to receive approval for newly diagnosed GBM during this year. And after that we will continue our negotiation with the Japanese authorities regarding reimbursement. So this is the process in Japan, which we started this negotiation a few months ago, but formal negotiates will start just after approval..

Lawrence Biegelsen

That’s very helpful. And just lastly, you talked about 60% of patients. GBM patients are managed in the community.

What percent of Optune right now just prescriptions are coming from community docs? How do you see that trending? And just lastly, few quarters typically your strongest quarter in terms of prescriptions, would you expect that to be the case this year as well? Thanks for taking the questions..

Asaf Danziger Chief Executive Officer & Director

So regionally, I just like to remind everyone, we start in the academic community and then we move to the community outside the academics to the community, and also we changed - we’re all changing this, well, part of our plan to move from neuro oncologist to rad-on and general oncologists.

And we see this trend moving this quarter was our best quarter ever. Regarding this conversion is just to remind you a few numbers, I think last year we had - 9% of our prescriber was rad-on, now it’s 50% of our prescribers. So we actually feel that we are on the right direction in this respect..

Lawrence Biegelsen

Okay. Thanks for taking the questions..

Asaf Danziger Chief Executive Officer & Director

I’m sorry, I’m sorry, I’m sorry, we move from 9% to 25%, I apologize for that..

Lawrence Biegelsen

25%.

Any color on whether Q4 will be the strongest quarter of the year, like we saw last year?.

William Doyle Executive Chairman

Yes, Larry. Again, very difficult for us to predict the future when we don’t give guidance, so I apologize for that, but….

Lawrence Biegelsen

Understood. But I will try. Thank you..

Asaf Danziger Chief Executive Officer & Director

Yes. Thanks, Larry..

Operator

Thank you. And our next question comes from the line of Tao Levy from Wedbush..

Tao Levy

Great. Good morning..

William Doyle Executive Chairman

Good morning, Tao..

Asaf Danziger Chief Executive Officer & Director

Hi, Tao..

Tao Levy

Just a couple of questions, any update on CMS reimbursement.

I might have missed it at the beginning, but any progress being made there?.

William Doyle Executive Chairman

Yes. So as Wilco said, we have yet to receive significant payment from Medicare fee-for-service program. We continue to treat all Medicare patients, who are prescribed and we continue to encourage the clinical community to prescribe for this population. So there is no barrier with respect to prescriptions.

This population continues to makeup quarter on quarter somewhere between 20% and 25% of our total. We are invoicing Medicare for these patients and providing all the appropriate paperwork for the challenges, as they require. We are also extremely active in discussions with them.

Unfortunately, this is not a process that has a defined clock as some do at the FDA.

I think all of the things that we mentioned and all of the achievements, the fact that such a large proportion now of the private payers are covering Optune and reaching contracted terms, the fact that we are included in the NCCN, and I think the data that we will be presenting at SNO, are all critical factors in ultimately achieving - getting where we want to be with CMS.

And the other thing I’ll say is, this process unfortunately is not unique for Optune. This is just what companies who are bringing new therapies to market have to go through..

Tao Levy

Got it.

And in terms of being able to change to accrual accounting, what are the missing parts there, Wilco?.

Wilco Groenhuysen

Well, I think, one missing part is no longer missing, which is the contracted lives. So the key issue, as we’ve discussed on earlier call, is our ability to reliably predict collection on basically a patient plan basis given the fact that we don’t have tens of thousands of patients, but about 1,000 patients.

That predictability is that that’s difficult to meet with statistical significance. Now, with the contract that test is no longer applicable, because you read on terms with contracted payers. So for that reason we talked about it in the earlier calls as well, Tao. We were pursuing contracting discussions and it was one of our objectives for this year.

And we are very pleased that we now hit 120 million. Some of these contracts will become effective later in the quarter, but it will enable us to switch to accrual-based revenue or recognition. Some other payer - patient plan combinations are not on the contract and are of volume, but we still may not be able to meet the statistical significance.

So over time you will see a migration from fully cash-based revenue recognition to fully accrual-based revenue recognition, and we will provide you ample transparency in that pathway as it occurs..

Tao Levy

Got you. And so UnitedHealth is for you guys under coverage or Optune under coverage at the beginning of next year.

Was that the third large payer that that was missing out of the - two out of the three, or was one of the other two already united?.

Wilco Groenhuysen

Yes. I’d like to make a distinction between covered lives and contracted lives, so covered lives is basically when you are within certain guidelines. You have approval to start coverage and you will get - the coverage issue was no longer a challenge.

So with 130 million lives under contract at the end of the third quarter with United’s publication of yesterday will add about 45 million to that effective January 1.

So if you do the math as of January 1, if nothing else changes we would have 175 million a little bit more than 175 million lives - covered lives in the United States privately insured lives, because - and that goes back to Bill’s comment as well. So with the vast majority of privately insured U.S. lives would be covered are on the contract or both.

While, the Medicare fee-for-service process is still ongoing, but we believe that’s an important factor in that discussion as well..

Tao Levy

Got you. So, I mean, why wouldn’t then accrual accounting kick-in in the first quarter? I mean, you would have practically the majority of the U.S.

adult population at that point?.

Wilco Groenhuysen

Yes, so first of all, our top line is not U.S. only. I think for the 120 million that would fully kick-in in the first quarter. It will partially kick-in in the fourth quarter, as these contracts has become effective. So the more significant impact, you would probably see in the first quarter, Tao..

Tao Levy

Got you. Okay, and just last one, sorry to belabor this.

But in terms of the data there that’d be coming out at SNO, any chance that you could move up in the NCCN guidelines from 2A to a 1 or is that just impossible?.

William Doyle Executive Chairman

Well, first of all, I think we are very happy with our NCCN inclusion today as a standard therapy. We don’t see that there is a material fact and we are delighted with 2A. No doubt the NCCN will take into account all data as it’s presented. And again, this is the most significant advance in GBM in over a decade.

We are going to - the community has asked for the full dataset. We are going to give them the full dataset. We are going to give them the extended long-term data. And again, we’ve already said that it’s significant improvement two, three, four years out. So no doubt this will be considered by the community..

Tao Levy

Fantastic. Thank you so much..

Operator

Thank you. And our next question comes from the line of John Scotti from Evercore ISI..

Volodymyr Nikolenko

Hi, guys, it’s Volodymyr Nikolenko on behalf of John Scotti and Mark Schoenebaum. So I have a few questions; first of all, congrats with sequential growth in prescription numbers.

So I’m wondering since the growth from Q2 to Q3 is more in line with what you guys have seen last year, I’m wondering if you think that maybe Q4 over the last year and Q1 over this year were some sort of an anomaly, and if there was any specific reason for this sharp increase of new prescription at that time period that sort of change overall trends in growth in new prescription.

Do you think it might have been some sort of warehousing effect? So I’m curious if you have any thoughts on that.

And going forward, do you expect any seasonality in general with new prescriptions either due to contract negotiation cycle or any other reasons?.

William Doyle Executive Chairman

Hi, Volod. So of course, we don’t know with precision what drives the specific trend. I think there is no doubt, recall that we received FDA approval in October last year. And that no doubt had a material effect on the prescriptions in Q4 and the continued jump into Q1. Historically, we have seen the summer is slower.

That’s also seen in other medical technology areas. I don’t want to attribute anything to a particular seasonality, but that is something that we have seen historically. And but I think more generally we are working to build the tools and to provide the education for all clinicians who treat GBM.

That as Asaf has mentioned, has included a, I won’t call the shift, but really a growth beyond just the academic centers to include the community med-oncs and rad-oncs. That population is a little more diffused.

We have dramatically grown this year the number of training centers, which has taken a lot of energy, but we think it’s critical for the long-term acceptance and growth. And we think that there is just a general familiarity that is occurring over time. All of the achievements on the coverage side also add confidence and ease paperwork for clinicians.

So I think all these things are additive. It doesn’t mean that we can predict with precision in the future. But I think it underlines our confidence as we establish Optune, TTFields as a standard of care..

Volodymyr Nikolenko

Okay. Thank you, Bill. And two sort of quicker questions. But first of all, you used to provide an estimate for the current penetration in the frontline GBM, so wondering if you have a new estimate for this quarter. I think it was 18 in the first quarter, 18%. And the second question, it’s been already asked about the duration of therapy estimates.

I just recall that you used to provide that if you do a simple math dividing number of patients currently on Optune by total number of new prescription in the previous period to period, you can get some sort of the rough estimate of duration of therapy.

I wondering if that math still works and the average duration of therapy is still between five to six months as a good estimate.

And if you will foresee any potential pushback from payers from policies from companies such as United, that sort of limit or they require continual approval of using Optune, if it’s confirmed there is no further progression in the tumor.

So I’m wondering if you see any potential limitations in case of patients will form to use Optune beyond progression. Thank you..

William Doyle Executive Chairman

Yes. So let me take your three questions and see if I get them right. First of all, with respect to market penetration, here again, we believe there are about 12,500 incidents in the U.S. each year. That number is growing a little bit with the aging population. But it’s a pretty stable number. We think that about 9,300 are eligible for Optune therapy.

That haircut largely has to do with the fact that a certain fraction of these patients deteriorate very quickly during the radiation therapy. And we start treatment after radiation. And with respect to the 569 prescriptions that we received in Q3, just doing the simple division, where we get to about that same 18%-ish penetration rate in the quarter.

With respect to duration of therapy, I talked about that a little bit, we see for the recurrent population still in the - before plus-months range. Newly diagnosed, again, we are about 50% or so newly diagnosed prescriptions in the quarter. We see a higher duration of therapy there.

I mentioned we don’t yet have the full field experience with the - particular with the gen-2 device to give a precise field number, but we think that the nine months number from EF-14 trial is a reasonable number. And I think with respect to modeling I think the average though as you’ve - you’re probably in a safe place.

I think your final question related to push back from payers. And again, I think what Wilco tried to describe is, we see the opposite.

I think with respect to the peer-reviewed data, the NCCN inclusion and the acknowledgement throughout the community that this is standard therapy for newly diagnosed GBM, as well as recurring GBM that we are having very constructive cooperative successful working relationship with our payers..

Volodymyr Nikolenko

Okay. Thank you..

Operator

Thank you. And that concludes our question-and-answer session for today. I would like to turn the conference back over to Novocure for any concluding comments..

William Doyle Executive Chairman

So first of all, again, I want to thank everybody for your time this morning and your interest in Novocure. It’s interesting it’s been about a year since we’ve been public. In some senses that time has flown and in others it feels like we’ve been public for five years.

But what I reflect on, when I think about the year is that we are a tremendously stronger company today than on the day we went public.

We have made really extraordinary achievements starting with FDA approval for newly diagnosed GBM, receiving peer-reviewed publication in JAMA, getting ourselves included in the NCCN guidelines, training centers across the county.

So we are now available on all 50 states, building the infrastructure in Europe, and really beginning to serve our patients particularly in Germany and Switzerland, and preparing for expansion.

All the work that we’ve done in Japan that we believe will bear fruit for patients in the very near future, the work that we’ve done to secure reliable payment and imbursement. Asaf mentioned the extraordinary efforts on behalf of patients to get the small light second generation device available first in Europe, and then in the U.S.

And after a year like that, as I said, I’ve nothing but confidence and enthusiasm for the year ahead. So thank you..

Operator

Thank you. Ladies and gentlemen, thank you for your participation on today’s conference. This does conclude the program and you may now disconnect. Everyone have a great day..

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