Q3 2019 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the Novacare third quarter 2019 earnings Conference call. At this time, all participants' lines are in listen only mode.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Novocure 3rd Quarter 2019 Earnings Conference Call. At this time, all lines are in a listen-only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero.
After the speakers presentation, there will be a question and answer session.
Ask a question during this session you need to press Star then one on your telephone.
Please be advised of today's conference maybe recorded.
If you require any further assistance. Please press star then zero.
Operator: I would now like to hand the conference over to your speaker today, Ms. Ashley Cordova, Senior 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 third quarter 2019 performance. I am joined today by our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Wilco Gronheisen. Our Chief Commercial Officer, Pritesh Shah, and our Chief Medical Officer, Ellie Benaim, will join us for Q&A. The slides presented today can be viewed on our website, www.novocure.com, by clicking on the link for third quarter 2019 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.
When I like the hand, the conference over to your Speaker today, Ms. actually Cordova Senior Vice President Finance and Investor Relations Ma'am you may begin.
Good morning, everyone and thank you for joining us to review Novocure third quarter 2019 performing.
I'm joined today by our executive Chairman Bill Doyle, our CEO soft on singer our CFO Walker Groenhuysen.
Our chief commercial officer protest Shaw and our Chief Medical Officer lead the name will join us for QNX.
It's like presenter today can be viewed on our website www dot now the care dotcom by clicking on the link for third quarter 2019 financial result, located any event 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 statement and actual results could differ materially from those projected a newspaper.
Operator: 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. Following our prepared remarks today, we will open the line for questions. Financials for the 3 and 9 months ended September 30, 2019 are available in our press release and in our pinned queue, both of which we released earlier this morning. With that, I will now turn the call over to Bill Doyle.
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 RCC filings.
We do not intend to update publicly any forward looking statements, except as required by law.
Following our prepared remarks today, we will open the line for question financial for the three nine month ended September Thirtyth 2019 are available on our press release and in our 10-Q, both of which we released earlier this morning.
With that I will now turn the call over to build oil.
Ashley Cordova: Thank you, Ashley, and good morning, everyone. Q3 2019 was a remarkable quarter for Novocure. We made significant progress in developing our commercial business, delivering our first quarter ever of positive net income. In addition to 42% revenue growth, we reported positive EPS of $0.02 and generated $15 million in cash flow from operations.
Thank you Ashley and good morning, everyone.
Three 2019 was remarkable quarter for no richer, we made significant progress in developing our commercial business delivering our first quarter ever positive net income.
In addition to 42% revenue growth, we reported positive EPS.
Two cents and generated 15 million in cash flow from operations.
William F. Doyle: With multiple levers to deliver continued near-term revenue growth, cash flow from our GBM business provides the financial flexibility and stability to ensure we can make the appropriate investments in our clinical pipeline and technology development to drive significant future value creation. The Tumor Treating Fields Platform is building momentum. We continue to enroll four phase three pivotal trials creating a significant market expansion opportunity for treating some of the most aggressive forms of cancer. I'll speak to our clinical progress later on this morning's call, but first, I'll ask Asaf to review recent commercial developments. [inaudible]
With multiple levers to deliver continue near term revenue growth.
Cash flow from our GBM business provides the financial flexibility and stability to ensure we can make the appropriate investments in our clinical pipeline and technology development to drive significant future value creation.
Tumor treating fields platform is building momentum we continue to enroll for phase three pivotal trials, creating a significant market expansion opportunity treating some of the most aggressive forms of cancer.
Speak to our clinical progress later on this morning's call, but first Alaska soft review recent commercial development.
Huh.
Asaf Danziger: Thank you, Bill. Our GBM business delivered another strong quarter of top-line growth. Net revenues were a record $92 million, up 42% versus the prior year. Prescriptions for newly diagnosed GBM continue to grow, representing 82% of the third quarter total. We ended the quarter with 2,750 active GBM patients on therapy, our 19th consecutive quarter of active patient growth since the initial presentation of our EF14 data. Our reimbursement rates for GBM also continue to improve. Last quarter, we received FDA approval under the HDE pathway for the Novo-TTF 100L system in combination with standard chemotherapy for the treatment of malignant pleural mesothelioma or MPM, our first FDA-approved torso indication.
Thank you Bill.
Oh GBM business delivered another strong quarter topline growth net revenues were a record $92 million up 42% versus the prior you.
Prescriptions for newly diagnosed GBM continued to grow representing 82% over the third quarter total.
Ended the quarter with 2007 on that 50 active GBM patients on therapy, our 19th consecutive quarter of active station growth sees then nishu presentation of out year 14 data Oh reimbursement rates for GBM also continued to improve.
Last quarter, we will see the FTC approval I know the HD pathway for the novelty D. S. One on at the end system in combination with standard chemotherapy for treatment of malignant brutal musically Omar or M. P. M. Our first if the approved tall syndication.
Asaf Danziger: Our initial launch efforts are focused on certification training and supporting the required IRB approval process at approximately 40 centers where we believe a majority of U.S. MPM patients are treated. By the end of the quarter, we had certified radiation oncologists at 10 high-volume centers, and two centers successfully completed the IRB approval process. With the start of our first NPM commercial patient in late September, for the first time ever, our third quarter active patient total includes an active patient treated for NPM. Certifications are ongoing, and we have a dedicated team focused on developing this business. We look forward to providing further updates on future calls.
Oh initial launch efforts I'll focus on certification training and supporting the required itll be approval process at approximately faulty centers, we believe I'm a Joe do a few S. M. P. M patients are treated by the end of the quota we satisfied with the actual him qualities of 10 high volume centers.
And to send to successfully completed diaby approval process.
We've just started to FFO first MPM commercial patients in late September for the first time and Oh third quarter active patients talk that includes an active patients treated for MPM certifications are ongoing and we have a dedicated team focused on developing this business, we look forward to providing for.
<unk> updates on future calls.
Oh fund, we have discussed geographic expansion as an additional live for new them growth and has available investment you know compassionately infrastructure prior to future potential launches in multiple solid tumor indications.
Asaf Danziger: Often, we have discussed geographical expansion as an additional level for near-term growth and as a valuable investment in our commercial infrastructure prior to future potential launches in multiple solid tumor indications. I am pleased to announce that we will enter our second big 5 EU market, expanding our commercial operations into France. Our initial focus will be developing KOL and patient advocacy relationships in GBM and establishing a path to reimbursement.
I'm pleased to announce that we will enter our second big five you market expanding our commercial operations into friends, Oh initial focus will be developing tailwind and patient advocacy relationships in GBM and establishing pass to reimbursement. These agreed to confess steps to building.
Wilco Gronheisen: These are critical first steps to building the foundation to launch GBM and to prepare for the potential significant market expansion opportunities in other indications over the next five years. Xilab, our partner in Greater China, also continues to make great progress. Xi formally launched Optium for GBM in Hong Kong in February, and the launch has outperformed their expectations. We view Xi's initial success in Hong Kong as an encouraging sign of Optium's compelling clinical profile and the unmet medical need it addresses ahead of the anticipated commercial launch in mainland China. The regulatory review of Optune in mainland China is on track. The Chinese National Medical Products Administration designated Optune for GBM, an innovative medical device, in August and has accepted the marketing authorization application. Xi is pursuing a clinical trial waiver for the GBM indication in China and, should a trial waiver be granted, intends to launch Optune in China before year-end. With that, I will turn the call over to Wilco to review our financials.
The foundation to loans GBM and to prepare for the potential significant market expansion opportunity in other indications over the next five years.
Zai lab, Oh pardon greater China also continues to make great progress XY for many loans opt in for GB I mean, I'm, calling in February and the launch has outperformed our expectations. We've use eyes initial success in I'm, calling as an encouraging sign of opt ins compelling clinical profile.
And the unmet medical need it addresses ahead of the anticipated commercial loans in mainland China.
The regulatory review of Optune in mainland China is on track the Chinese National Medical products administration designated opt in for GBM and innovative medical device in August and has accepted the marketing authorization application.
The ice pursuing a clinical trial waiver for the GBM indication in China and to the try where they'll be granted intends to loans optune in China before year end.
With that I will turn the call it over to we'll go to review our financial.
No what your ended the third quarter in a strong financial position, we made significant progress in developing our commercial business delivering another quarter of record net revenues.
Wilco Gronheisen: Novocure ended the third quarter in a strong financial position. We made significant progress in developing our commercial business, delivering another quarter of record net revenue. I am proud to report that the third quarter also marked the first quarter ever of positive net income; third quarter net revenues were $92.1 million, growing 42% year over year and growing 6% quarter over quarter. In fact, Q3 marked the third consecutive quarter in 2019 of greater than 40% year over year revenue growth. Trailing 12-month net revenues now exceed $320 million.
I am proud to report third quarter also marked the fourth quarter ever positive net income.
Third quarter net revenues for $92.1 billion growing 42% year over year, and growing 6% quarter over quarter affect Q3 market third consecutive quarter in 2019 or greater than 40% year over year revenue growth.
Trailing 12 month net revenues exceed $320 million.
In addition to compete effectively patient broke you have seen assisting people went into net revenues book to burn activation.
Wilco Gronheisen: In addition to continued active patient growth, we have seen a sustained improvement in the net revenues booked per active patient. Our revenue per patient has benefited from continued improvements in reimbursement rates in both the U.S. and EMEA. In addition, we recognized the initial benefit from Medicare with half a million in third-quarter net revenues from beneficiaries built under the newly defined coverage policy effect of September 1, 2019. Moving into the fourth quarter, our team is focused on working through the typical administrative ramp-up to ensure we realize the full revenue benefit from Medicare as soon as possible. Gross profit in the quarter was $69.2 million, reflecting a 75% gross margin. Rosmartin continues to benefit from ongoing efficiency initiatives and increasing scale. We continue to invest in research and development with $18.8 million in R&D expenses in the quarter, up 44% versus the third quarter of 2018. This was primarily driven by an increase in clinical trial and personnel expenses for our Phase III pivotal trials and an increase in costs associated with medical affairs, regulatory, and engineering. Our third quarter SG&A expenses were $46.5 million, up 23% versus the third quarter of 2018. This was primarily due to increased marketing expenses and personnel costs
Our revenue per patient benefited from continued improvements in reimbursement rates for both the U.S. anemia. In addition, they recognize the initial benefit from Medicare with half a million third quarter net revenues from beneficiaries built into the newly defined coverage policy effect of September for 2019.
Well look into the fourth quarter. Our team is focused on working for the typical administrative ramp up the we should realize the full revenue benefit from Medicare as soon as possible.
Gross profit during the quarter $69.2 million, reflecting a 75% gross margin.
Gross margin continues to benefit from ongoing efficiency initiative and increasing scale.
We continue to make that in research and development with $18.8 million in R&D expenses into quarter up 44% person to third quarter of 2018.
It was primarily driven by an increase in clinical trial in personnel expenses for phase three pivotal trials and an increasing costs associated with medical affairs regulatory and engineering.
Our third quarter as you know you expenses were $46.5 million up 23% for just a third quarter of 2018, driven primarily by increased marketing expenses and personnel costs to support our growing commercial business.
Wilco Gronheisen: In the third quarter, we recorded an income tax benefit of 1.5 million dollars as a result of the R&D credit claimed in the United States. Our net income was $1.9 million, with 2 cents in earnings per share. Cash flow from operations was $14.9 million. We ended the third quarter with $312.6 million in cash, cash equivalents, and short-term investments, an increase of $28 million from the prior quarter.
The third quarter, we recorded an income tax benefit a $1.5 million as a result of R&D credit claims in the United States.
Our net income was $1.9 million, but two cents in earnings per share.
Cash flow from operations was $14.9 billion.
We ended the third quarter for 312.6 million in cash cash equivalents and short term investments an increase of 28 million from the prior quarter.
Revenue and operating margins for the GBM business continued to something investments you know clinical pipeline and technology development.
William F. Doyle: Revenue and operating margins for the GBM business continue to fund the investments in our clinical pipeline and technology development. Moving forward, we are committed to balancing improved operating efficiency with investments for sustainable long-term success. In summary, we are pleased with the sustained revenue growth and the level of investment and profitability in the third quarter. We are confident this momentum will carry us through the remainder of 2019 and into 2020. With that, I will hand the call back to Bill for an update on our pipeline.
Going forward, we're committed to balancing improved operating efficiencies with investment for sustainable long term success.
In summary, we are pleased with a sustained revenue growth and the level of investment in profitability in the third quarter. We are confident this momentum will carry us through the remainder of 2019 and into 2020.
But that they will have to go back to bill for an update on our pipeline.
Thank you welcome.
Tumor treating fields is backed by a considerable volume of compelling preclinical and clinical data.
William F. Doyle: Thank you. Welcome.
William F. Doyle: Tumor treating fields are backed by a considerable volume of compelling preclinical and clinical data. There is a growing body of evidence supporting the broad applicability of tumor treating fields across multiple solid tumor cancers in combination with various therapies. I am pleased to report the results from our stellar trial were recently published in the Lancet Oncology, one of the world's leading clinical oncology research journals. The STELLAR trial studied the use of tumor-treating fields delivered via the NOVA-PTF-100L system in combination with pemetrexid plus cisplatin-carboplatin as a first-line treatment for patients with unresectable, locally advanced, or metastatic malignant pleural mesothelioma.
There's a growing body of evidence supporting the broad applicability of tumor treating fields across multiple solid tumor cancers in combination with various therapies.
I am pleased to report the results from our stellar trial were recently published in the lancet oncology one of the world's leading clinical oncology research journals.
The Stoller trial studied the use of tumor treating fields deliberate via the no but P. T. F 100 health system in combination with Pemetrexed said, plus this plot carbo clubs as a first line treatment for patients with Unresectable locally advanced or metastatic malignant pleural me for field.
Stellar trial demonstrated an impressive median overall survival of 18.2 months when tumor treating feels was added to standard chemotherapy.
William F. Doyle: This stellar trial demonstrated an impressive median overall survival of 18.2 months when tumor treating fields were added to standard chemotherapy. Tumor Treating Fields' platform is building momentum with an increasing presence at key oncology congresses globally, including 80 presentations in the third quarter alone. Highlights include the first presentation of in vitro data studying tumor treating fields in combination with full FOX chemotherapy in gastric cancer and the presentation of in vitro and in vivo data studying tumor treating fields in combination with serafinib in liver cancer. In both studies, combining tumor treating fields with chemotherapy enhanced treatment efficacy based on cancer cell count, apoptosis induction, and overall effect. Also, results were presented by external authors expanding the preclinical evidence that tumor treating fields activate the innate immune system, providing a strong rationale for studying tumor treating fields in combination with immune checkpoint inhibitors.
Tumor treating fields platform is building momentum with an increasing presence at Ti oncology Congresses globally, including 80 presentations in the third quarter alone.
Like conclude the first presentation of in vitro data studying tumor treating field in combination with FOLFOX chemotherapy in gastric cancer.
And the presentation of in vitro and Nvvault data studying tumor treating fields in combination with sorafenib in liver cancer.
In both studies, combining two we're treating fields with chemotherapy enhance treatment efficacy based on cancer cell count it popped hostess induction and overall effect.
Also results were presented by external authors expanding the preclinical evidence the tumor treating field.
Activate the innate immune system, providing a strong rationale for studying tumor treating fields in combination with immune checkpoint inhibitors. These data align with our research to date showing tumor treating feels to be additive to four synergistic with other anti cancer agents without evidence of any.
Dose limiting cumulative toxicity.
William F. Doyle: These data align with our research to date showing tumor treating fields to be additive to or synergistic with other anti-cancer agents without evidence of any dose-limiting cumulative toxicity. We believe there is a growing appreciation for the potential value of tumor-treating fields across the broader oncology landscape. In all tumor cell lines we have tested, tumor treating fields have had a consistent effect, and we have not found a tumor cell line that does not respond to tumor treating fields, in addition to our ongoing preclinical and clinical programs. We have a significant opportunity to improve optune efficacy and ease of use through product engineering and development.
We believe there is a growing appreciation for the potential value of tumor treating fields across the broader oncology landscape.
All tumor cell lines, we've tested tumor treating fields has a consistent effect and we have not found a tumor cell line, but does not respond to tumor treating field.
In addition to our ongoing preclinical and clinical programs, we have a significant opportunity to improve optune efficacy and ease of use.
Through product engineering and development.
I just by data published in the Red Journal earlier, this year, showing that higher doses of tumor treating feel to improve survival of newly diagnosed GBM patients. Our engineering teams are working to design and develop enhancements to our transducer arrays, and our trend juicer or re layout mapping software intended to increase tumor.
William F. Doyle: Guided by data published in the Red Journal earlier this year showing that higher doses of tumor treating fields improve survival of newly diagnosed GBM patients, our engineering teams are working to design and develop enhancements to our transducer arrays and our transducer array layout mapping software intended to increase tumor treating field intensity and thus efficacy. We look forward to providing further updates on future calls.
Treating field intensity and not the efficacy.
We look forward to providing further updates on future calls.
We are determined to provide tumor tweeting feel therapy to cancer patients with a variety of solid tumor types, who may benefit from the treatment. Our teams continue to make progress enrolling patients randomized phase three pivotal trial in brain metastasis.
William F. Doyle: We are determined to provide tumor treating field therapy to cancer patients with a variety of solid tumor types who may benefit from the treatment. Our teams continue to make progress in enrolling patients in randomized phase 3 pivotal trials in brain metastases, lung cancer, pancreatic cancer, and ovarian cancer, and in our phase 2 pilot study in liver cancer. If approved, the indications in our late-stage pipeline will create a more than 20-fold increase in the U.S. addressable market alone. Novocure is a global commercial oncology company. In the third quarter, commercial execution drove strengthening financial performance and our first ever quarter of positive net income. Our proprietary tumor-treating fields cancer therapy platform is building momentum, marked by our third consecutive quarter in 2019 of greater than 40% year-over-year revenue growth. We see a bright future for Novocure, and our focus is unwavering on disciplined execution intended to deliver both sustainable near-term revenue growth from existing indications and significant long-term shareholder value creation through pipeline and product development. Thank you for your time this morning. With that, I'll turn the call over to the operator for questions.
Lung cancer pancreatic cancer ovarian cancer and in our phase two pilot study in liver cancer.
If approved indications our late stage pipeline will create a more than 20 fold increase in the U.S. addressable market alone.
No, but your as a global commercial oncology company.
The third quarter commercial execution drove strengthening financial performance and our first ever quarter positive net income.
Our proprietary tumor treating feels cancer therapy platform is building momentum marked by our third consecutive quarter in 2019 of greater than 40% year over year revenue growth.
We see a bright future for no mature and our focus is unwavering on disciplined execution intended to deliver both sustainable near term revenue growth from existing indications and significant long term shareholder value creation through pipeline in product development.
Thank you for your time this morning with that I'll turn the call over to the operator for questions.
Thank you.
Ladies and gentlemen, if you have a question at this time. Please press the star followed by the number one key on your Touchtone telephone. If your question has been answered or you wish or move yourself from the Q. Please press the pound ski once again to ask a question. Please press star and then one now.
And our first question comes from Vijay Kumar from Evercore ISI. Your line is open.
Hey, guys. Congrats nice revenue from this morning.
Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star followed by the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Once again, to ask a question, please press the star and then one now. And our first question comes from Vijay Kumar from Evercore ISI. Your line is open.
Maybe I'll start on the revenue from you know quick housekeeping question Wilco based on your comments. So it looks like the reimbursement trends. We're seeing here. This is sustainable is that the right way to read through you just when you look at the reimbursement per patient <unk> in the U.S.
Yeah. We believe is this a sustainable as we said another calls earlier on we've made significant improvement in the reimbursement per patient now with Medicare reimbursement kicking in with the first half million recognized in the third quarter and remember that only related to by September buildings, and we would improve further improvement in billings fragmentation.
Wilco Gronheisen: Hey guys, congrats on a nice revenue front this morning. Maybe I'll start on the revenue front, you know, quick housekeeping question, Wilco, based on your comments, it looks like the reimbursement trends we're seeing here are sustainable. Is that the right way to read through, just when you look at the reimbursement per patient in the U.S.?
And there was no true up or catch up payments in the INSEEC you're correct.
No material catch up payments.
That's helpful. And then now you know will one on a script volumes I know you guys have had the new GBM worse. This record in GBM you know maybe could you parse out what the new GBM strip trend was into Q because the overall it seems a little light and I'm just curious when the record in GBM dynamic and you know could analyze and now and.
Wilco Gronheisen: Yeah, we believe it is sustainable. As we said in other calls earlier on, we've made significant improvements in reimbursement per patient. Now, Medicare reimbursement is kicking in with the first half million recognized in the third quarter. And remember, that only related to September billings, and we would make further improvement in billings per active patient.
In a given new GBM is 80 plus percent should we be thinking about next next year. You know these trends a wash away and you should see a clean script volume for next year.
Wilco Gronheisen: And there were no true-up or catch-up payments in 3Q, correct?
Wilco Gronheisen: No material catch-up payments.
I think you attempt that goes into into guiding and we do believe that the trends we've seen in newly diagnosed scripts as a percentage of total any improvement that we've seen over the last few quarters, resulting an 82% into third quarter is likely to further improve to what extent is.
Wilco Gronheisen: That's helpful. And then, you know, one on script volumes, I know you guys have had the new GBM versus record in GBM, you know, maybe could you parse out what the new GBM script trend was in the queue? Because the overall picture seems a little late. And I'm just curious when the record in GBM dynamic could annualize and, you know, given that the new GBM is 88 plus percent. Should we be thinking about next year, you know, these trends will wash away, and you should see a clean script volume for next year?
It's difficult to predict that right now, but it is it is a consistent trends that we see no signs of fault discontinuation.
Hey, now maybe one last one on the on not China before I, let others jump on you know it looks like it's incremental common share on on not mean as I labs.
Get getting possibly a try labor in China, if if they do get a trial labor maybe could you up you know.
Wilco Gronheisen: I think you're tempting us into guiding. We do believe that the trend we've seen in newly diagnosed Scripps as a percentage of total and the improvement that we've seen over the last few quarters resulting in 82% in the third quarter is likely to further improve. To what extent it is difficult to predict it right now, but it is a consistent trend that we see no signs of discontinuation.
Could you size, the China opportunity for us how big is that market or Rob you know how should we be thinking about revenue ramp in China.
Yes so.
We continue to be extremely pleased with our partnership.
With I lab as we mentioned in the prepared remarks.
Wilco Gronheisen: and maybe one last one on China before I let others jump on. You know, it looks like it's incremental comments here on, you know, Xi Labs getting possibly a trial waiver in China. If they do get a trial waiver, maybe could you, you know, size the Chinese opportunity for us? How big is that market, or how should we be thinking about revenue ramping up in China?
The launch in Hong Kong has gone extremely well.
And the work toward approval in mainland China is also going extremely well we mentioned that.
The Chinese and mph designated Optune as an innovative medical device in August that was a key step.
And of course, they also accepted the marketing application, which is also a key step.
And zeigeist preparing for a potential commercial launch is early as a the end of Q4.
Wilco Gronheisen: yeah
With that said.
Wilco Gronheisen: Yeah, so we continue to be extremely pleased with our partnership with Xilab. As we mentioned in the prepared remarks, the launch in Hong Kong has gone extremely well, and the work toward approval in mainland China is also going extremely well. We mentioned that the Chinese NMPA designated Optune as an innovative medical device in August. That was a key step. And, of course, they also accepted the marketing application, which is also a key step. Xi is preparing for a potential commercial launch as early as the end of Q4. With that said, we estimate that there are 45,000 people in China that are diagnosed with GBM each year. This is the largest market for GBM, but I think it's too early for us to predict exactly what the uptake would be post-approval there. Thanks, guys.
We estimate.
There are 445000 people in China that are diagnosed with GBM. Each year. This is the largest market for GBM, but I think it's too early for us to predict exactly what the uptake would be post post approval there.
Thanks, guys.
Thank you.
Next question comes from Larry Biegelsen from Wells Fargo. Your line is open.
Hi, good morning, its lay calling in for Larry and thank for taking my question.
I want to ask my onto cyanide mesothelioma, you mentioned the first that patient is therapy and trained they Ukraine 10 centers pull apart can you talk about the ran to training the 40 centers, they you're targeting kind of what time period.
Okay.
Sure so.
Thank you for the question I want to introduce a protest shot to this audience. This morning protest is our chief commercial officer and as the person who's leading the value lab launch as well as the rest of our commercial business I'm going to turn it over to protest to make comments great. Thank you.
Wilco Gronheisen: Thanks guys.
Operator: Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open. Hi, good morning, it's Lei calling in for Larry, and thanks for taking my question. I want to ask one about Tucson Mesothelioma. You mentioned the first patient is on therapy and that you've trained 10 centers so far. Can you talk about the ramp to training the 40 centers that you're targeting, kind of the time period you're referring to?
Bill and thank you lay for the question. So we're very pleased with the MPM launch, it's where the launch is on track where in the first stages of the launch, which if you recall from or GBM days. The first step is to certify the centers.
William F. Doyle: Thank you for the question. I want to introduce Pritesh Shah to this audience this morning. He is our Chief Commercial Officer and is the person who is leading the iLab launch as well as the rest of our commercial business. I'm going to turn it over to him to make comments.
I'll I'll focus on the audience that we're starting to find because it's really important for visa Sealy OMA as well as our future pipeline that you heard about we're focusing on the radiation oncologist at these 40 centers.
Pritesh Shah: Great. Thank you, Bill, and thank you, Lei, for the question. So we're very pleased with the NPM launch. The launch is on track. We're in the first stages of the launch, which, if you recall from our GBM days, the first step is to certify the centers. I'll focus on the audience that we're certifying because it's really important for mesothelioma as well as our future pipeline that you heard about. We are focusing on the radiation oncologists at these 40 centers where mesothelioma is primarily treated, and our goal here is to ensure that the radiation oncologist becomes the key prescriber for tumor treating fields, NOVOTTF100L, and for mesothelioma, and also moving forward in our other indications. The second step of the launch is the IRB process.
Our music Deeley OMA is primarily treated and our goal here is to ensure that the radiation oncologist becomes the key prescriber for tumor tweeting fields, Nobody Tee up 100, Allen mesothelioma and also moving forward in our other indications.
The second step of the launch is the IR be a process. So as you know the H.D. requires an IR be approval that step also takes a bit of time and the onus here is on the center. So we were very pleased to see the first two centers get IR be approval.
In in quarter three the second step now where the rest of the centers are now in the IR be process. So our goal is to continue certifying centers as the first step in making sure that we are able to get get access to mesothelioma patients with I know what do you get 100 al and we will continue to work on.
Pritesh Shah: So, as you know, the HDE requires IRB approval. That step also takes a bit of time, and the onus here is on the center. So we were very pleased to see the first two centers get IRB approval in quarter three. The second step now, or the rest of the centers are now in the IRB process. So our goal is to continue certifying centers as the first step in making sure that we are able to get access to mesothelioma patients with ANOVA-TTF100L, and we will continue to work on that through the end of this year and into next year, so we can ensure that 40 centers are certified and ready to go.
Through the end of this year going into next year. So we can ensure those 40 centers are certified and ready to go.
Great. Thank for that and then if I can ask the question just on that and the pipeline Fine you I think was on the last call you talked about a couple of new GBM studies that you're looking at one optimal my prediction and another one I've templates PMT plus other agents.
Pritesh Shah: And then, on the pipeline front, I think it was on the last call you talked about a couple of new GBM studies that you're looking at. One, optin plus radiation, and another one, optin plus TMZ plus other agents. Is there a status update on that?
A status update on them.
[noise] [noise], so I'm going to turn.
The the Q when they over to Elie Benet Elie joined us.
On the last call for the first time, but is joining us again today to.
Handled the questions on the pipeline, so I'll turn it over the Elliot.
Thank you Bill.
William F. Doyle: So I'm going to turn the Q&A over to Elie Benet. Elie joined us on the last call for the first time, but he is joining us again today to handle the questions on the pipeline, so I'll turn it over to Elie. Thank you, Bill.
There's really no material updates that we still planning. These two studies, we as you know we intended to advances that scientific evidence supporting these optune in GBM.
Elie Benaim: There are really no material updates. We're still planning these two studies. As you know, we intended to advance the scientific evidence supporting the use of Optune in GBM and really gather additional information about Optune's optimal use.
And really gather additional information about the up to an optimal views.
Okay. Thanks, if I can squeeze in one last one any update on the national reimbursement in Germany. Thank you.
[noise].
Elie Benaim: Okay, thanks. And if I can squeeze in one last one, any update on the national reimbursement in Germany? Thank you.
Type stuff so.
You know.
Asaf Danziger: Hi, this is Asaf. So, you know... I just would like to remind everyone that our reimbursement right now in Germany is in very good shape. But we are still working on national reimbursement in Germany.
I guess would like to we remind everyone that though you know, we however, reinvestment right now in Germany in very good shape.
So when we and but we're still working on on a national reimbursement in Germany.
Asaf Danziger: [inaudible]
We also.
Really a doing discussion with the red regulatory and and just.
Asaf Danziger: Discussion with the Regulatory Authorities in Germany about Reinvestment We know that, you know... This discussion will bring some food over next year.
With the regulatory authorities in Germany above the investment and.
We believe that you know a.
These discussion the with.
Bring some fruit there over the next year.
[laughter].
Thank you.
Operator: Thank you. And our next question comes from Corey Casimo from JP Morgan. Your line is open.
And our next question comes from Cory Kasimov from JP Morgan Your line is open.
William F. Doyle: Hey, good morning guys. Thanks for taking my questions. I wanted to go back to the sequential prescriptions, and obviously, the number of active patients continues to climb quarter over quarter, but you had the slight drop in Rx. So I'm curious, is there a seasonality component to this or some other type of, like, one-off impact or another dynamic in the marketplace that we should be thinking about when we look at sequential script runs?
Hey, good morning, guys. Thanks for taking my questions wanted to go back to this sequential prescriptions and obviously the active patients continues to climb quarter over quarter, but you had the slight drop in Iraq. So I'm curious is there a seasonality component to this or or some type of other some other type of like one off impact or or another.
Dynamic in the marketplace that we should be thinking about when we look at sequential script trends.
We're very focused of course Cory on on script trends, we don't believe that Weve reached any sort of Peaker plateau. There are more many more patients with GBM in the U.S. interactive markets, who can benefit from the therapy.
William F. Doyle: We're very focused, of course, Corey, on script trends. We don't believe that we've reached any sort of peak or plateau.
William F. Doyle: There are many more patients with GBM in the U.S. in our active markets who can benefit from the therapy. It is a brand new therapy, of course. It's a completely new concept, and so we expect it to grow more slowly over time to peak than, for instance, a new drug or pharmaceutical.
It is a brand new therapy of course, it's a it's a completely new concept in so we expected to grow.
More more slowly overtime to Pete then for instance, a new drug or pharmaceutical.
Operator: Okay. And then a follow-up question on your non-small cell lung cancer study. There are a couple things here.
Okay, and then a follow up question on your non small cell lung cancer study couple things here Im curious can you talk about the accrual rates across geographies and then I just want to make sure I understand the design or the statistical analysis here. So the primary analysis, if I'm right pooled across all patients regardless of background PD, one use and then.
Elie Benaim: I'm curious, can you talk about the accrual rates across geographies? And then I just want to make sure I understand the design or the statistical analysis here. So the primary analysis, if I'm right, is pooled across all patients, regardless of background PD-1 use. And then the secondary endpoints, we'll look at subgroups with or without checkpoint inhibitors. Is that right? And if so, are you comfortable that you have Hi, this is Ale again.
In the secondary endpoints will look at subgroups with or without checkpoint inhibitors is is that right and if so are you comfortable that you have enough powering on those secondary endpoints.
Hi, This is how they again, so think of recall and for your second called the answer is yes, I think we will have power for both the primary thinking there.
Elie Benaim: So thank you for your call. And for your second call, the answer is yes. I think we have power for both the primary and secondary endpoints. And we think that the study is getting even more interesting in the sense that we now have two arms that are quite current in combination with PD-1 inhibitors, but we don't require PD-1 diagnosis or pathology to be in the study. On the recruitment side, as we have mentioned before, we have ongoing 68 sites across North America and Europe, but we don't really provide patient enrollment figures, but we'll press release our last patient enrollment. Okay. I understand that you don't require PD-1, but do you expect that the study will differ between groups in terms of background PD-1?
Endpoints and ER, we we think that this study is getting even more interesting I in the sense of we now have become the two arms are quite a current ill in combination with PD, one inhibitors, but we don't require PD one.
Diagnosis or you know pathology to be into study on the recruiting inside we as we have mentioned before we have a ongoing 68 sites across North America in Europe , but we don't provide you know really patient enrollment figures. So we'll but were press release, our last patient enrollment okay.
I understand that you don't require PD, one, but do you expect it to study will be relatively balanced between between groups in terms of background PD one years.
Elie Benaim: That's the expectation. Okay. Thanks, guys. I appreciate it.
Ah that's expectation yes, okay. Thanks, guys appreciate it.
[noise]. Thank you. Our next question from Greg Gilbert from Suntrust. Your line is open.
Operator: Thank you. Our next question is from Greg Gilbert from SunTrust. Your line is open.
William F. Doyle: Thank you. I just want to quickly start with a commercial question. You talked about the expansion into France. Can you share some thoughts on where else you plan to expand commercially in the next couple of years before I shift to a couple of R&D questions?
Thank you I just want to quickly start with commercial question you talked about the expansion into France can you can you share some.
Thoughts on where else you plan to expand commercially in the next couple of years before I shift a couple R&D questions.
Yeah I think.
William F. Doyle: Hi Corey, this is Bill. We will announce new markets as we enter them. I think the obvious markets are the rest of the big five countries in Europe, and our plan is to take them one at a time. The next one will be France.
Hi, Corey this is bill.
We will announce.
New markets as as we enter.
I think the obvious.
Markets or the rest of the big five countries in Europe .
And.
Our plan is to take them one at a time and the next one will be France.
Okay great.
William F. Doyle: Okay, great. On the research side, can you talk about how the mesothelioma approval has affected the momentum of research interest in torso applications? I imagine there's a logistical sort of hurdle there of having an official approval on the torso, but can you talk about any quantification or at least some anecdotal color around additional research interest you're seeing outside of your walls on the torso?
On the research side can you talk about how the muses helium approval has affected the momentum of research interest and tour still applications I imagine there's a logistical.
Sort of hurdle there, having an official approval on the tour. So but can you talk about any quantification or or at least some anecdotal color around additional research interest you're seeing outside of your waltz on the torture I'll I'll start and maybe.
William F. Doyle: I'll start and maybe, you know, if Ellie or Pritesh have some comments and anecdotes, they can jump in. But I think, clearly, the approval for mesothelioma has been very important to Novocure. It's the first indication outside of the brain, which is substantial evidence that this therapy can be used for other tumors. It opens a whole new audience of oncologists who are now interested in learning about the therapy and who are interested in doing research about it. So I think... Above and beyond the relatively small indication, which will still be good business in time for Novocure, it was a real milestone in terms of validating the potential torso application.
Failure protests have some comments and anecdote they can jump in but I I think clearly the approval in new facility on the has been very important to know Victor.
First indication outside of the brain.
Which was substantial evidence that this can this therapy can be used for other tumors.
It opens a whole new audience of oncologists, who are now interested in the in learning about the therapy, who are interested in doing research about the therapy.
So I think.
Above and beyond the relatively small indication.
Which will still be good business.
In time for no richer it was a real milestone in terms of validating the the potential torso application.
Okay, and then I think protest touched on this a little bit already but can can you speak a little bit about how the preparations for me to fill the OMA.
Pritesh Shah: Okay, and then I think Pritesh touched on this a little bit already, but can you speak a little bit about how the preparations for mesothelioma... We'll specifically relate to, say, lung cancer, should you be in a position to launch in a couple of years in the lung setting, how much overlap, sort of centers, and other logistical issues are there. Thanks.
Well, specifically relate to say long should you be.
Decision to launch and a couple of years in the lung setting how much overlap and.
Sort of centers and other logistical.
Pritesh Shah: Sure, thank you for that question. So it's too early to talk about non-small cell lung cancer, but we're very excited to prepare the market for mesothelioma. I think one of the key elements of our preparation is to focus on one audience, the radiation oncologists. Being successful on this front will allow us to really just have more of a turnkey launch when we get to non-small cell lung cancer. So what the mesothelioma launch allows us is building experience with the radiation oncologist and the torso application, and then, over time, as we get to the non-small cell lung cancer market preparation, allow for a more seamless launch and execution on that front. Okay, thanks.
Issues are there thanks.
Sure. Thank you for that question. So it's too early to talk about non small cell lung cancer, but we're very excited to prepare the market with means that the Liam I think one of the key elements of our preparation is to focus on one audience radiation oncologists being successful on this front will allow.
US to really just have to more of a turnkey launch when we get to non small cell lung cancer. So what that means of helium a launch allows us is building experience with the radiation oncologist with the torso application.
Then over time as we get to non small cell lung cancer market preparation.
Allow for more seamless launch.
And the execution on that front.
Okay. Thanks.
Thank you. Our next question comes from Esther Roger Ballou from Oppenheimer. Your line is open.
Operator: Thank you. Our next question comes from Esther Rajavalu from Oppenheimer. Your line is open. Hi, good morning. Thank you for taking my questions. Following up on Greg's question on mesothelioma, can you maybe share some updated thoughts on how you view the OUS opportunity here and whether you're likely to pursue something? It's outside the U.S.
Hi, Good morning, Thank you for taking my questions.
Following up on Greg's question on mesothelioma can you maybe share some updated thoughts on how you view, the or U.S. opportunity here in whether you're likely to PC something.
Outside the U.S.
Sure. Thank you for that question. So right now our focus is on ensuring a successful launch in the U.S.
Pritesh Shah: Thank you for that question. Right now, our focus is on ensuring a successful launch in the U.S. We're still learning as we bring the treatment to the 40 centers that we talked about, and we're in the process of getting the CE mark in Europe, which would then allow us the opportunity to gain regulatory access in Europe.
We're still learning as we are bringing the treatment to the 40 centers that we talked about and we're in the process of CE Mark in Europe , which would then allow us the opportunity to the gain regulatory access in Europe .
You will need to run at trial in Europe , I assume separate from that that is not our our expectation understanding at this time.
Pritesh Shah: You'll need to run a trial in Europe, I assume, separate from the U.S. trial. That is not our expectation or understanding at this time. And then in China, you are booking incremental revenues. Can you help us understand in Hong Kong how the product is being priced and any read-throughs from Hong Kong to the broader Chinese market?
Gotcha, and then and then in China, you are booking incremental revenues can you help us understand in Hong Kong, how the product is being priced in any retreat.
From Hong Kong to the broader Chinese market.
Wilco Gronheisen: Morning Esther, this is Wilco. We do disclose revenue coming from China associated with the ZAI partnership. It effectively consists of three components, as you know. One is, at this point in time, a relatively modest royalty revenue. The second one is, as you will recall, part of the agreement with ZAI was that we would supply them with equipment, both arrays and boxes. So that supply is also in our revenue line. And the third component consists of the amortization of the initial sign-on fee. So those are the key components. Upon approval of ZAI, and let's assume a successful commercial launch, we would expect that royalty stream to pick up. But it's very difficult to predict at this point in time to what extent, and I'll refer back to the comments that Bill made earlier in the call, that there's a significant opportunity there, but it's too early to call how much of that 45,000 patient base can be captured by ZAI. But we do think pricing overall will most likely be more or less in line with immunotherapies in China.
Yes. Good morning, Esther This is wilco, Oh, we do disclose a revenue coming from China associated with design partnership. It effectively consists of two or three components issue. No. One is a at this point in time, a relatively modest royalty.
Revenue the second one is.
As you will recall part of the agreements besides that we would supply them with.
With equipments, both the race and boxes. So that supply is also you know in our revenue line into third component.
Consists of the amortization of the initial sighinolfi. So those are the key components.
Upon approval of site and let's assume.
The successful commercial launch you would expect that boreal history to with to pick up it's very difficult to predict at this point in time to what extent and I will refer back to the to the comments that bill made earlier on in a goal.
That there's significant opportunity there, but it's too early to call how much of that 45000 patient base can be captured by my side, but we do think pricing overall, most likely will be more there will be more or less in line with immunotherapies in China.
Okay and then my last question you had talked about potentially using optune in earlier lines of therapy can kind of radiation. When do you anticipate initiating that child and what it implications if that is becomes a reality.
William F. Doyle: And then my last question: you had talked about potentially using Opune in earlier lines of therapy concurrent with radiation. When do you anticipate initiating that trial, and what are the implications if that use becomes a reality?
William F. Doyle: So maybe I'll take the last question first and then turn it over to Ellie. So there we talked a little bit today about the preclinical evidence both in vitro and in vivo. We don't always talk about this on calls, but we have a significant internal R&D engine, and now there's significant external academic R&D being done in tumor treating fields. One aspect of that R&D is the combination of tumor treating fields with radiation. So our approval today is for use in GBM after radiotherapy, because the preclinical evidence supports its use with radiation. We see that it enhances the efficacy of the radiation, so this is something that we intend to study in a phase 3 trial. The implications for the business are that one, the patients would start earlier. That's approximately two additional months of therapy, and again, the reason we're conducting the trial would be to prove that it would give them an extended survival benefit, which could potentially extend the benefit in the long term. So those are some of the potential benefits should this prove out in the human population.
So maybe I'll take the last question first and then turn it over to to Ellie.
So there we talked about a little bit today about the preclinical evidence both in vitro and in vivo.
We don't always talk about this on the calls, but we have a significant internal.
R&D engine and now there are significant external academic R&D being done in tumor treating fields.
One aspect of that R&D is the combination of tumor treating fields with radiation. So her approval today is for use in GBM after radio therapy. The preclinical evidence supports use.
With radiation, we see that it enhances the efficacy of the radiation.
So this is something that.
We intend to study in a phase three trial the implications for the business our that one the patients would start earlier.
Thats approximately two additional months of therapy.
And again art.
The reason, we're conducting the trial would be to prove that it would give them extended survival benefit which could potentially extend the the benefit of the long term so.
So those are some of the potential benefits should this prove out given in human population.
William F. Doyle: Thank you. I appreciate it. Thank you. Our next question comes from Defe Wing from Azuho.
Thank you appreciate it.
Thank you. Our next question comes from just say Lang from Mizuho. Your line is open.
Operator: Your line is open. Hi, good morning. And thanks for taking my questions. So just a couple quick ones with regard to, could you talk about the CMS reimbursement pathway and potential timelines for metastasizoma? And then maybe, perhaps, that could help us to understand the business opportunity.
Hi, good morning, and thanks for taking my questions. So just a couple quick ones with regards to you could you talk about D or CMS reimbursement pathway and potential timelines on mesothelioma, and then maybe perhaps helps us to understand the ER business up to.
Wilco Gronheisen: Just one question, Dufay, right? This is welcome.
Maybe outside of the United States, Let's say on on Europe , primarily for mesothelioma.
Wilco Gronheisen: Let's start with the first part of your question, and that would be Medicare revenue recognition. We're actually very pleased that we're able to recognize revenue in the third quarter for patient treatment as of September 1st. The achievement of Medicare reimbursement and establishing that was a great accomplishment in the second quarter. It took a lot of work to be able to figure out and design and implement a process that will allow us to recognize fully the benefit of the Medicare billings. We recognized half a million in September.
Just one question Difei right. This is will [laughter], let's start with the first part of your question, let's see the Medicare revenue recognition, we're actually very pleased that we're able to recognize revenue into third quarter for.
Patient treatments as off off as of September 1st the achievement of the Medicare reimbursement and establishing that was a great accomplishment in into second quarter. Thanks, a lot of work to be able to.
Figure out and design and implement a process that will allow us to recognize fully the benefit of the Medicare billings, we recognized half a million in the in September we're making significant improvements in those processes and expect the next few quarters to come to full realization of Medicare revenue.
Wilco Gronheisen: We're making significant improvements in those processes and expect the next few quarters to come to full realization of Medicare revenue. The second part of your question related to... Europe. Europe. Opportunities. Europe.
Yes.
The second part of your question related to.
You actually was immediately.
Wilco Gronheisen: Yeah, I think we touched upon a few of those topics earlier on, and I think Asaf mentioned them as well. So we are making significant progress again in securing national reimbursement in Germany. Asaf alluded to that we still think that in 2020, either in March or in October, more likely than not, in the second part of the year, we would expect to have national reimbursement in Germany. But we don't think it's material, and we talked about this in the past as well, to overall revenue as we are very successful in filing claims on a case-by-case basis and realizing substantial revenue from that. So it will help us in efficiency and the processing of claims. It will probably have a very modest, if any, impact on our net revenue. We're working on securing reimbursement in Switzerland and Israel to become a reality, but I think the quality of the data, and the support that we have in the physician and patient communities give us hope that those discussions will also be concluded positively.
Yeah, I think we compete and I think we touched upon a few of those topics a earlier on and I think Josef mentioned as well. So we are making significant progress again in securing national reimbursement in Germany. The soffe alluded to that we still think that in 2020, either in March or in October most more like.
Actually the not in the second part of the year, we would expect to have national reimbursement in Germany. We don't think it's materially we talked about in the past as well to overall revenue as we are very successful in filing claims on a case by case basis and realizing substantial revenue from that so it will help us in inefficiency and processing.
King of claims it will probably have a very modest at any impact on our net revenue.
We're working on give secured reimbursement in Switzerland and Israel.
It's too early to give any indication on on when that might might.
Become a reality, but I think the quality of the data to support that we happened to physician and patient community gives us hope that also those discussions will be concluded it to positively.
And then ontelaunee subject to 'em mesothelioma D is X U.S. does ex U.S. has a bigger opportunity then the opportunity in the U.S.
Wilco Gronheisen: And then training subject to methicillium, is XUS, does XUS have a bigger opportunity than the opportunities in the U.S.?
Pritesh Shah: I'll answer that question. This is Pritesh again.
Yes, I'll answer that question. This is pretentious again so thank you for your question.
Pritesh Shah: So thank you for your question. As we mentioned, related to the opportunity outside of the United States, our focus is to ensure that we are successful in bringing the treatment to patients in the U.S., and we're in the process of getting the CE mark. And in terms of the opportunity, it'll depend on which country we go into, and we have not made that determination just yet.
As we mentioned related to the opportunity in outside of the United States. Our focus is to ensure that we are successful in bringing it treatment to patients in the U.S. and we're in the process of the CE Mark and in terms of the opportunity it will depend on which country. We go in and we have.
Not made that determination just yet.
William F. Doyle: Okay, so that leads to my final question on the gastric cancer that Zylab is running or planning to run trials on. And do you see a significant opportunity, assuming that the trial is positive, do you see a significant opportunity in the U.S. or the rest of the world outside of China?
So on that leads to my final question I'm, not gastric cancer data lobbyists running or planning to run trials and do you see a significant opportunity assuming that trial is positive.
We see significant opportunity in the U.S. or rest of the world outside of China.
William F. Doyle: Yeah, so the trial that's being, that is designed, and we're in the stages of implementation is a Phase II trial, so it's, consistent with our other Phase II trials, we'll focus on safety, of course, where we don't expect to see an issue, and then on hints of efficacy. From there, we would expect to perform a Phase III trial. The largest opportunity for gastric cancer research is Asia; that's why we're doing the trial in Asia. There are opportunities that are smaller in the U.S., and of course, we would exploit those as well.
So the trial that's being.
That is designed and we're in the stages of implementation is a phase two trial.
So it's a consistent with our other phase two trials will.
Focus on safety of course were we don't expect to see an issue and then on.
Hints of efficacy from there we would expect to perform a phase three trial.
The largest opportunity in gastric cancer is Asia, that's why we're doing the trial in Asia there are opportunities.
That are smaller in the U.S. and of course, we would expect those as well.
Wilco Gronheisen: Thank you. Thank you. And we do have a follow-up from Vijay Kumar from Evercore ISI. Your line is open.
Thank you.
Thank you and we do have a follow up from Vijay Kumar from Evercore ISI. Your line is open.
Wilco Gronheisen: Hey, thanks guys. Just a couple of housekeeping or follow-up questions, if you will, on the new GBM. Can you clarify how the new GBM strips are growing? Because I think they've been growing double digits in the teens range. Did those trends change at all in the queue?
Hey, Thanks, guys, just a couple of housekeeping or follow up questions. If you will on.
The new GBM can you.
Can you clarify that new GBM scripts are growing because I think they've been growing double digits up in the teens Fang Jeff did those trends changed at all in into Q.
Wilco Gronheisen: No, we saw a 2% increase. Sorry, Vijay, this is Wilco.
No we saw a 2% increase sorry to Jay. This is welcome so at 2% increase Q3 over Q2, we had 1076 newly diagnosed scripts, which is as we said earlier on about 82% of total scripts.
Wilco Gronheisen: We saw a 2% increase in Q3 over Q2. We had 1,076 newly diagnosed Scripps, which is, as we said earlier, about 82% of total Scripps.
Elie Benaim: That's helpful. On non-small cell lung cancer, I know the trial, it's got four arms, you know, in combination with chemo, in combination with Keytruda. And now these IO drugs, they've been, you know, they're, you know, they're, they have first-line status. But the trial itself is you're looking at second-line patients. I'm just curious whether because of the combination of the IOs they've been given first line status, would that change the opportunity for you guys? Or could you get a first line indication based on this trial? Or would that have to be a separate trial?
That's helpful on the non small cell lung cancer I know the trial got four arms.
In combination with chemo combination with dot Keytruda and know that these io drugs that have been you know there.
You know there they have the first lien status, but the trial itself is a you're looking at second line.
Patients I'm, just curious at weather because the combination the iOS they'll get been given the first lien status would that change.
The opportunity for you guys or could you get a first line indication based on this trial or would that how to be a separate trials.
Yeah. So this is heavily the.
Elie Benaim: Yeah, so this is Sally. The We don't think that with this trial we'll get a first-line indication. But certainly, as we have mentioned before, we know that the combination of tumor-treating fields with any cancer will be potentially beneficial. So we think that there's still space in the non-smoked lung cancer area for second-line treatment in combination with the immuno-checkpoint inhibitors or also in combination with docetaxels. So there's always going to be, unfortunately, checkpoint inhibitors do not cure non-smoked lung cancer. So all these patients, eventually, will receive potentially docetaxels, and so we also will have that covered in the combination.
We don't think that with this trial will get up first line indication, but certainly as we have mentioned before.
We know that the combination of tumor treating fields with any.
Cancer, but it will be potentially beneficial. So we think that this there's still a space in the non small cell lung cancer.
Area for a second line treatment with combination with the immune check point inhibitors or also with a in combination with that does it taxes. So there's always going to be the unfortunately, a checkpoint inhibitors in the south shore those ones had on cancer. So.
All these spaces have entered it would receive.
Potentially does it textiles and so we also will have that covered in the combination.
Elie Benaim: That's helpful. And maybe one last one.
That's helpful and maybe one last one.
William F. Doyle: Free cash flow, positive, you know, cash is building up on the balance sheet. I'm just curious about thoughts on capital deployment, because that really is ballooning every quarter, right? And it looks like for your trial needs, expenses, your ongoing operations are enough to sustain. Any thoughts on capital deployment?
Free cash flow positive Lena cashes building up on the balance sheet I'm just curious on thoughts on capital deployment, because that's really is a ballooning every quarter right and it looks like Oh for your trial needs expenses your ongoing operations enough to assist in any thoughts on cap deployment.
William F. Doyle: Yeah, so I think, you know, first and foremost, we'd like to emphasize that the revenue and profits now from the GBM business provide us with great flexibility to do everything that we need to do to build long-term value with our tumor treating fields platform, and that includes paying for the full clinical program, and it also includes paying for technology development because we see a significant opportunity as a device to continue to develop the technology both to improve efficacy further and to So that's our focus right now, but, you know, it's clear that we do have this cushion and flexibility to undertake everything that we need to undertake to build long-term value.
Yes, So I think you know first and foremost.
We like to emphasize that the revenue and profits now from the GBM business provide us great flexibility to do everything that we need to do to build long term value with our tumor treating fields platform.
Concludes the full paying for the full clinical program and it also includes paying for technology development, because we see a significant opportunity as a device to continue to develop the technology both to improve efficacy further.
And to improve patient comfort.
So that's our focus right now.
But.
It's clear that we do have this.
Cushion and flexibility to undertake everything that we need to undercut take to build long term value.
Wilco Gronheisen: Thanks, guys.
Thanks, guys.
William F. Doyle: Thank you, and I am showing no further questions from our phone lines, and I'd like to turn the conference back over to Bill Doyle for any closing remarks.
Thank you and I am showing no further questions from our phone lines I don't like to turn the conference back over to Bill Doyle for any closing remarks.
William F. Doyle: Yeah, so I'd just like to, once again, thank you all for your interest in Novocure. This was another milestone quarter for us, our first quarter of profitability. For those of us who have been involved in this project now for 18 plus years, Pektasov has just crossed his 18-year milestone with the company, this is really a tremendous affirmation of years and years of hard work. So, thank you.
So I just like the once again, thank you all for your interest in overture.
This was another milestone quarter for us our first quarter of profitability for those of US who have been involved in this project now for a.
18, plus years affect us off his just crossed as 18 year milestone with the company. This is really a tremendous affirmation of years and years of hardware. So thank you.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program you may all disconnect everyone have a wonderful day.
Operator: Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone, have a wonderful day. BF-WATCH TV 2021