Q1 2022 Novocure Ltd Earnings Call
Good day and welcome to the Novocure.
Operator: Good day, and welcome to the Novocure Q1 2022 earnings call. At this time, all participants are in a listen-only mode.
Q1, 2022 earnings call at this time, all participants 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 one on your touchtone telephone. If anyone should require assistance during the call, please press star then zero to reach an operator.
After the Speakers' presentation there'll be a question and answer session to ask a question. During the session you will need to press Star then one on your touch some telephone.
If anyone should require assistance during the call. Please press Star then zero switching operator.
Ingrid Goldberg: As a reminder, this call may be recorded. I would like to turn the call over to Ingrid Goldberg. You may begin. Good morning, everyone, and thank you for joining us to review Novocure's first quarter 2022 performance. I'm joined on the phone by our executive chairman, Bill Doyle, and our CFO, Ashley Cordova on the phone by our executive chairman, Bill Doyle, Our CEO Asaf Danziger and other members of the executive leadership team are also on the call and available for Q&A.
As a reminder, this call maybe recorded.
I'd now like to turn the call over to Ingrid Goldberg you may begin.
Good morning, everyone and thank you for joining us to review <unk> first quarter 2020 cheaper format.
I'm joined on the phone by our executive Chairman Bill Doyle, and our CFO Ashley Cordova.
C E O S off Donziger and other members of the executive leadership team are also on the call and available for Q&A.
Ingrid Goldberg: The slides presented today can be viewed on our website, www.novacure.com, by clicking on the link for first quarter 2022 financial results located in the quarterly report section of our investor relations page. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements, and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control, including those risks and uncertainties described from time to time in our SEC filings.
Slides presented today can be viewed on our website www dot novocure dot com by clicking on the link for first quarter 2022 financial results located in the quarterly report section of our Investor Relations page.
Ingrid Goldberg: We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation.
Before I 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.
Ingrid Goldberg: We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributed to our capital structure, tax rate, and material non-cash items and best reflects the financial value generated by our business. Reconciliations of this and any other non-GAAP financial measures to GAAP financial measures are also included in our press release, in the appendix of the supplemental slides accompanying this presentation, and in our Form 8K filed with the SEC today.
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.
Where appropriate we will refer to non-GAAP financial measures to the eyewear business, specifically adjusted EBITDA, a measure of earnings before interest taxes, depreciation amortization and share based compensation.
We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributed to our capital structure tax rate and material noncash items and best reflects the financial value generated by our business.
Reconciliations of this and any other non-GAAP financial measures to GAAP financial measures are also included in our press release and the appendix of the supplemental slides accompanying this presentation and in our form 8-K filed with the SEC today.
Ingrid Goldberg: These materials can also be accessed from our investor relations page on our website. Following our prepared remarks today, we will open the line for your questions. Financials for the three months ending March 31, 2022 are available in our press release and in our 10-Q, both of which we released earlier this morning. With that, I will now turn our call over to our Executive Chairman, Bill Doyle.
These materials can also be accessed from our Investor relations page of our website.
Following our prepared remarks today, we will open the line for your questions.
Financials for three months ended March 31, 2022 are available in our press release and in our 10-Q, both of which we released earlier this morning.
With that I will now turn our call over to our executive Chairman Bill Doyle.
Bill Doyle: Thank you, Ingrid. At Novocure, we are focused on our mission to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor-treating field. Since our founding over 20 years ago, we have completed multiple pivotal trials in glioblastoma, established a sustainable commercial business, and built a robust clinical pipeline that we believe will enable our company to serve thousands of future patients. We believe we are just scratching the surface of the ultimate potential for tumor-treating fields to extend the lives of cancer patients.
Thank you Ingrid and.
And no mature we are focused on our mission to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor treating fields.
Since our founding over 20 years ago, we have completed multiple pivotal trials in Glioblastoma established a sustainable commercial business and built a robust clinical pipeline that we believe will enable our company to serve thousands of future patients.
We believe we are just scratching the surface of the ultimate potential for tumor treating fields to extend the lives of cancer patients.
For years through our commercial and clinical research programs, we have work to extend the pool of patients who potentially can benefit from tumor treating fields therapy with multiple key milestones anticipated in the near term we are on the verge of realizing that goal.
Bill Doyle: For years, through our commercial and clinical research programs, we have worked to extend the pool of patients who potentially can benefit from tumor-treating fields therapy. With multiple key milestones anticipated in the near term, we are on the verge of realizing that goal. Over the next 24 months, we anticipate data readouts from several pivotal trials across a variety of solid tumor cancers. We also expect exciting product development improvements to reach cancer patients later this year.
Over the next 24 months, we anticipate data readouts from several pivotal trials across a variety of solid tumor cancers.
We also expect exciting product development improvements to reach cancer patients. Later this year. Finally in addition to expanding our commercial footprint in Glioblastoma, we are laying the pre commercial foundations for multiple launches in new indications.
Bill Doyle: Finally, in addition to expanding our commercial footprint in glioblastoma, we are laying the pre-commercial foundations for multiple launches in new indications. On today's call, we will begin with a review of our commercial execution in the quarter. We will then discuss the near-term catalysts within our clinical pipeline. Finally, we will close with a discussion of our first quarter financial performance.
In today's call, we will begin with a review of our commercial execution in the quarter.
We will then discuss the near term catalysts within our clinical pipeline.
Finally, we will close with a discussion of our first quarter financial performance.
Bill Doyle: Our GBM business remains a key driver of our long-term success, providing the critical financial support for our investments in future growth. Our GBM business also provides the commercial blueprint across numerous regions for potential future launches in new indications. Our GBM commercial strategy is focused on broadening our eligible patient population and driving greater penetration in our current market. Geographic expansion is a key pillar of our strategy to expand the eligible GBM patient population. France is the next major market in which we are pursuing reimbursement.
Our GBM business remains a key driver of our long term success, providing the critical financial support for our investments in future growth.
Our GBM business also provides the commercial blueprint across numerous regions for potential future launches in new indications.
Our GBM commercial strategy is focused on broadening our eligible patient population and driving greater penetration in our current markets.
Yeah.
Geographic expansion is a key pillar of our strategy to expand the eligible GBM patient population.
France is the next major market in which we are pursuing reimbursement.
Bill Doyle: Discussions with French health authorities are ongoing, and we anticipate reaching agreement on the terms of national reimbursement and launching in France by year end. We are actively building up commercial infrastructure in additional markets in North America and EMEA with the goal of making PT fields therapy available to many more GBM patients in need. In-person education is the most fruitful approach to convince health care providers of the value to patients of using opt-in therapy and to increase adoption in our current market, although face-to-face contact has been severely constrained due to the pandemic.
Discussions with French health authorities are ongoing and we anticipate reaching agreement on the terms of national reimbursement and launching in France by year end.
We are actively building, our commercial infrastructure and additional markets in North America, and EMEA with the goal of making TT fields therapy available to many more GBM patients in need.
In person education is the most fruitful approach to convince health care providers of the value to patients who've using opportune therapy and to increase adoption in our current markets.
The face to face contact has been severely constrained due to the pandemic. We are seeing early signs of some COVID-19 related restrictions lifting and areas of the U S. That said, we believe the return to normal prescriber access will be gradual as providers continue to wrestle.
Bill Doyle: We are seeing early signs of some COVID-related restrictions lifting in areas of the US. That said, we believe the return to normal prescriber access will be gradual as providers continue to wrestle with staffing shortages and turnover. We are hopeful that the current reopening trends hold and markets continue to normalize as we head into the summer. Academic centers remain an area of under-penetration.
With staffing shortages in turnover.
We are hopeful that the current reopening trends hold and markets continue to normalize as we head into the summer.
Academic centers remain an area of under penetration.
Bill Doyle: These centers treat a significant portion of GBM patients and are key to increasing the broader adoption of tumor treating fields. We work to engage academic oncologists on the clinical frontier through our GBM-focused trials. Our TRIDENT trial in newly diagnosed GBM has proven to be a productive avenue to engage expert academicians.
These centers treat a significant portion of GBM patients and are key to increasing broader adoption of tumor treating fields.
We work to engage academic oncologists on the clinical frontier through our GBM focused trials.
Our Triton trial in newly diagnosed GBM has proven to be a productive avenue to engage expert academicians.
Bill Doyle: As a reminder, Trident is studying the use of tumor-treating fields concurrently with radiation therapy, rather than following radiation in newly diagnosed GBM patients. This study is enrolling well, and we now have 92 clinical sites actively recruiting. Our Investigator Sponsor Trial Program is another tool to engage and collaborate with academics on college campuses. We currently support 37 ISTs, with a number focusing on new approaches to treating GBM, including novel therapy combinations and new patient populations.
As a reminder, Triton is studying the use of tumor treating fields concurrently with radiation therapy.
Rather than following radiation in newly diagnosed GBM patients.
This study is enrolling well and we now have 92 clinical sites actively recruiting.
Our investigator sponsored trial program is another tool to engage and collaborate with academic oncologists. We currently support 37, Isps with a number of focusing on new approaches to treating GBM, including novel therapy combinations and new patient populations tried it.
Bill Doyle: Trident and our IST program are paramount to generating more clinical data and building greater understanding and awareness of our therapies. Turning to our clinical pipeline, in 2022, we expect to release data from both pivotal and pilot studies, complete enrollment of another pivotal trial, and commence a limited release of our Next Generation Arrays. 2022 is the first of several years in which we expect to reach clinical milestone. As a reminder, we currently have four Phase III pivotal studies ongoing and expect to read out in the near term.
And our Isd program are paramount to generating more clinical data and building greater understanding and awareness of our therapy.
Turning to our clinical pipeline in 2022, we expect to release data from both pivotal and pilot studies complete enrollment of another pivotal trial and commenced a limited release of our next generation arrays.
'twenty two is the first of several years and which we expect to reach clinical milestones.
As a reminder, we currently have four phase III pivotal study is ongoing and expect to read out in the near term.
Bill Doyle: The first to read out will be our lunar study investigating the safety and efficacy of tumor-treating fields together with docetaxel, or physician's choice PD-1 inhibitor, in non-small cell lung cancer. We anticipate lunar top-line data by year-end following 12-month follow-up from the last patient in. The Lunar Protocol contemplates multiple global standards of care, enabling tumor-treating fields to work concomitantly with a number of treatment regimens for non-small cell lung cancer, which vary by geographic region.
First to read out will be our lunar study investigating the safety and efficacy of tumor treating fields together with docetaxel or physician's choice PD, one inhibitor in non small cell lung cancer.
We anticipate lunar topline data by year end following 12 month follow up from last patient in.
Lunar is critical as it has the potential to unlock an entirely new patient population that can benefit from tumor treating fields therapy.
The lunar protocol contemplates multiple global standards of care, enabling tumor treating fields to work concomitantly with a number of treatment regimens in non small cell lung cancer, which vary by geographic region.
Next we expect to complete the follow up period of our innovate three study in the first half of 2023.
Bill Doyle: Next, we expect to complete the follow-up period of our Innovate3 study in the first half of 2023. As a reminder, the pivotal Innovate 3 study is investigating the efficacy of TT fields and taclitaxel for the treatment of recurrent ovarian cancer. We completed enrollment in Innovate 3 in the fourth quarter of last year, and in March, we received a recommendation from the DMC to continue the trial to completion. We are now following patients through the 18 months from the last patient and the follow-up period before releasing data in 2023. The third of our current PIVL studies to read out is our METIS study, which is investigating the use of TT fields following stereotactic radiosurgery for the treatment of brain metastases from non-small cell lung cancer.
As a reminder, the pivotal innovate three study is investigating the efficacy of TT fields in paclitaxel for the treatment of recurrent ovarian cancer.
We completed enrollment of innovate three in the fourth quarter of last year and in March received a recommendation from the DMC to continue the trial to completion.
We are now following patients through the 18 months from last patient in follow up period before releasing data in 2023.
The third of our current pivotal studies to readout as our Medis study, which is investigating the use of TT fields. Following stereotactic radiosurgery for the treatment of brain metastases from non small cell lung cancer.
We expect to complete enrollment of <unk> later this year.
Final data will be available in 2023, following the completion of a 12 month last patient in follow up period.
Finally, our <unk> III study is investigating the efficacy of TT fields, together with Gemcitabine and Nab paclitaxel for the treatment of locally advanced pancreatic cancer.
Bill Doyle: We expect a complete enrollment in NADIS later this year, and final data will be available in 2023 following the completion of a 12-month last patient in follow-up period. Finally, our PANOVA 3 study is investigating the efficacy of TT fields together with gemcitabine and nabpaclitaxel for the treatment of locally advanced pancreatic cancer.
Pancreatic cancer holds one of the most devastating prognoses with a five year survival rate of only 11% we.
Bill Doyle: Pancreatic cancer holds one of the most devastating prognoses, with a five-year survival rate of only 11%. We expect to complete enrollment in PANOVA 3 in 2023, with data to follow in 2024. I would also like to mention the EF31 pilot study investigating the safety and efficacy of TT fields together with chemotherapy in gastric cancer, for which we will share data in the coming months. Gastric cancer is one of the most prevalent cancers in Asia, with nearly half a million annual diagnoses in China alone.
We expect to complete enrollment of <unk> three in 2023 with data to follow in 2024.
I would also like to mention the Es 31 pilot study investigating the safety and efficacy of TT fields together with chemotherapy in gastric cancer for which we will share data in the coming months.
Gastric cancer is one of the most prevalent cancers in Asia with nearly half a million dollars annual diagnoses in China alone.
Bill Doyle: EF31 is a single arm phase 2 study that is the next clinical step in our abdominal cancer program. We are looking forward to sharing the data from EF31 with you and to reviewing potential next steps in gastric cancer. Each of our clinical trials takes years to design, execute, and read out. I am grateful for the tireless effort and dedication of our Novocure teams, investigators, and patients. We are at the beginning of a transformational period for our company.
E. F 31 is a single arm phase II study that is the next clinical step in our abdominal cancer program.
We are looking forward to sharing the data from <unk> 31, with you and to reviewing potential next steps in gastric cancer.
Each of our clinical trials takes years to design and execute and read out.
I am grateful for the tireless effort and dedication of our Novocure teens investigators and patients.
We are at the beginning of a transformational period for our company.
Bill Doyle: In the next eight months, we anticipate vital clinical data from pivotal and pilot trials, completion of enrollment in our third pivotal study in less than 12 months, and a meaningful product development milestone with the European market release of our next generation array. Swiftly following these milestones, we expect to share additional pivotal data sets and potential new indications. Collectively, these trials could increase Novocure's addressable patient population by over 10 times, offering new treatment solutions for tens of thousands of cancer patients.
And the next eight months, we anticipate vital clinical data from pivotal and pilot trials.
Completion of enrollment of our third pivotal study in less than 12 months and a meaningful product development milestone with European market release of our next generation of race.
Swiftly following these milestones we expect to share additional pivotal data sets and potential new indications.
Collectively these trials could increase <unk> addressable patient population by over 10 times offering new treatment solutions for tens of thousands of cancer patients.
I'd like to conclude my comments today by highlighting one of our remarkable patients.
Bill Doyle: I'd like to conclude my comments today by highlighting one of our remarkable patients. Wade Lewis was diagnosed with GBM in 2019 and will soon celebrate his second anniversary on OptumTherapy. Following his diagnosis, Wade formed a uniquely strong bond with neuro-oncologist Dr. Ekekobe Fonkum of Baylor Scott & White Health through their mutual belief in serving others. As a visionary thinker, Dr. Fonkum is one of the founders of the Society of Neuro-Oncology in Sub-Saharan Africa.
Dave Lewis was diagnosed with GBM in 2019 and will soon celebrate his second anniversary an opportune therapy <unk>.
Following his diagnosis Wade formed a uniquely strong bond with neuro oncologist, Dr. ACA Kobe, Hong Kong of Baylor, Scott <unk> White health through.
Through their mutual belief and serving others as.
As a visionary thinker Dr. <unk> is one of the founders of the society of Neuro oncology sub Saharan Africa, and together with Wade recently completed filming a documentary to drive greater awareness in GBM.
Bill Doyle: And, together with Wade, I recently completed filming a documentary to drive greater awareness in GVM. It is an inspiration to see our patients and physicians working together to advance patient care and reach more GBM patients in need. I will now turn the call over to Ashley to discuss our first quarter financial performance. Thank you, Bill.
It is an inspiration to see our patients and physicians working together to advance patient care and reach more GBM patients in need.
I will now turn the call over to Ashley to discuss our first quarter financial performance.
Thank you Bill.
Ashley Cordova: We are incredibly excited about the potential catalysts ahead of us in the coming years. That said, we remain laser focused on execution within our core GVN bits, which continues to fuel our aggressive investments and long-term growth initiatives. In the first quarter of 2022, we generated $138 million in net revenue.
We are incredibly excited about the potential catalysts ahead of us in the coming years.
That said, we remain laser focused on execution within our core <unk> business, which continues to fuel our aggressive investments and long term growth initiatives.
In the first quarter 2022, we generated $138 million in net revenue a year over year increase of 2%.
Ashley Cordova: A year-over-year increase of 2%. The number of active patients on therapy is our principal revenue driver. We ended the quarter with 3,549 patients on therapy, an increase of 3% from the same period last year.
The number of active patients on therapy as our principal revenue driver.
We ended the quarter with 3549 patients on therapy and increase of 3% from the same period last year.
The key drivers per active patient growth remain expansion of our global footprint and increased penetration in our active markets.
Ashley Cordova: The key drivers for active patient growth remain expansion of our global footprint and increased penetration in our active market. Given the various puts and takes in patient demand, we are reiterating our full-year active patient growth to be between 2 and 5 percent in 2022. We also experienced a tailwind in the U.S. from collections of previously denied and appealed claims. However, as in the past, the cadence and size of these payments are impossible to predict.
Given the various puts and takes in patient demand. We are reiterating our full year active patient growth to be between two and 5% in 2022.
We also experienced a tailwind in the U S from collections of previously denied <unk> appeal to claims.
As in the past the cadence and size of these payments are impossible to predict.
Ashley Cordova: Given the unpredictability of collections of previously denied and appealed claims, we expect net revenues per active patient per month to be approximately the same in 2022 as realized in the fourth quarter of 2021. Our growth margin in the quarter was 80%. The cost of revenues per active patient per month was roughly unchanged versus the prior year, with increasing supply chain efficiencies offsetting the impact of broader economic challenges. Growth margin was also positively impacted by a decrease in Zylab purchases.
Given the unpredictability of collections of previously denied claims we expect net revenues per active patient per month to be approximately the same in 2022 as realized in the fourth quarter at 2021.
Our gross margin in the quarter was 80%.
Cost of revenues per active patient per month was roughly unchanged versus the prior year with increasing supply chain efficiencies offsetting the impact of broader economic challenges.
Gross margin was also positively impacted by a decrease in <unk> purchases.
As always we are evaluating opportunities to further reduce our cost of goods sold, especially as we expand our scope into new geographies and potential new indications.
Ashley Cordova: As always, we are evaluating opportunities to further reduce our cost of goods sold, especially as we expand our scope into new geographies and potential new indications. SG&A expenses totaled $68 million in the first quarter, an increase of 9% year-over-year.
SG&A expenses totaled $68 million in the first quarter, an increase of 9% year over year.
Ashley Cordova: With multiple pivotal trials nearing completion, we are investing in market research and strategic planning activities across the tumor treating field platform, particularly in lung and ovarian cancer, to ensure we can hit the ground running upon regulatory approval. This includes foundational investments in commercial infrastructure, as well as initiatives to enhance our capabilities to treat significantly larger patient populations. To summarize, our core GBM business generates strong cash flow, enabling us to substantially invest in ongoing research and development activities across the tumor treating field's platform. In the first quarter of 2022, we invested $42 million in research and development.
With multiple pivotal trials nearing completion, we are investing in market research and strategic planning activities across the tumor treating fields platform, particularly in lung and ovarian cancer to ensure we can hit the ground running upon regulatory approval.
This includes foundational investments in commercial infrastructure as well as initiatives to enhance our capabilities to treat significantly larger patient population.
To summarize our core GBM business generates strong cash flow, enabling us to substantially invest in ongoing research and development activities across the tumor treating fields platform.
In the first quarter of 2022, we invested $42 million and research and development.
Ashley Cordova: Direct clinical trial costs represent approximately 30% of our total R&D spend and can fluctuate quarter to quarter depending on CRO services delivered. R&D remains one of our best uses of capital, and we are investing aggressively in future growth and development initiatives, specifically in basic scientific research, new clinical studies, and next-generation device components. Our net loss for the first quarter was $0.04 per share, or $5 million.
Direct clinical trial costs represent approximately 30% of our total R&D spend and can fluctuate quarter to quarter, depending on CRO services delivery.
R&D remains one of our best uses of capital and we are investing aggressively and future growth and development initiatives, specifically and basic scientific research New clinical studies and next generation device component.
Our net loss for the first quarter was four cents per share or $5 million.
Ashley Cordova: Adjusted EBITDA for the quarter was $27 million, and we ended the quarter with $932 million in cash and short-term investments on the balance. Our focus remains on investing strategically to pursue long-term organic growth opportunities and ensure our organization and infrastructure are prepared for future launches. As we prepare for a new phase in growth, it is inspiring to reflect on how far we have come and how far we have yet to go. It has been ten years since we completed our first pivotal study using a completely novel therapy to treat GVN patients. Since then, we have treated over 24,000 patients, and we are preparing to commence our next chapter with the potential to serve tens of thousands of critically ill cancer patients.
Adjusted EBITDA for the quarter was $27 million and we ended the quarter with $932 million in cash and short term investments on the balance sheet.
Our focus remains on investing strategically to pursue long term organic growth opportunities and ensure our organization and infrastructure and prepared for future launches.
As we prepare for a new phase in growth. It is inspiring to reflect on how far we have come as a company.
It has been 10 years since we completed our first pivotal study using a completely novel therapy to treat GBM patients.
Since then we have treated over 24000 patients and we are preparing to commence our next chapter with the potential to serve tens of thousands of critically ill cancer patients.
Ashley Cordova: The fundamentals of our business are strong, and the future is bright for Novocure. We are primed for the moment and look forward to updating you on what stands to be a very exciting year. Ladies and gentlemen, if you'd like to ask a question, please press star, then 1. If your question has been answered and you'd like to remove yourself from the queue, press the pound key.
<unk> of our business are strong and the future is bright for Novocure. We are primed to meet the moment and look forward to updating you on what stands to be a very exciting year.
Ladies and gentlemen, if you'd like to ask a question. Please press Star then one if your question has been answered and like to Wonder yourself from the queue press the pound key.
Operator: Our first question comes from Corey Kasimov with J.P. Morgan. Your line is open. Hey, good morning, guys. Thank you for taking the questions. Two of them for you.
Our first question comes from Cory <unk> with Jpmorgan. Your line is open.
Corey Kasimov: First, can you talk about the jump in net revenue per active patient per month in Q1 and how sustainable you think that is going forward? As I know, this tends to fluctuate a bit. And then the second question, Ashley, talking about the increase in sales and marketing and anticipation of potential future approvals and launches and new indications. So on that front, can you discuss the approach for building a long sales force in particular, given that is the next potential indication, obviously, a very large market? Thanks a lot.
Hey, good morning, guys. Thank you for taking the questions two of them for you.
First can you talk about the jump in net revenue per active patient per month in Q1, and how sustainable you think that is going forward as I know this tends to fluctuate a bit.
Then the second question Ashley you talking about the increase in sales and marketing in anticipation of potential future approvals and launches of new indications.
So on that front can you discuss the approach for building along Salesforce in particular, given that is the next potential indication, obviously, a very large market. Thanks a lot.
Sure. Thanks for the question Cory and I will start by addressing the pricing you are correct that we saw very strong net price per patient in the U S. In the first quarter that was driven both by the completion of the administrative ramp up for Medicare and strength in our commercial business as well as <unk>.
Ashley Cordova: Sure. Thanks for the question, Corey. And I'll start by addressing the price.
Ashley Cordova: You are correct that we saw a very strong net price per patient in the U.S. in the first quarter. That was driven both by the, you know, completion of the administrative ramp-up for Medicare and strength in our commercial business, as well as some tailwinds from previously denied and appealed claims. If you look to the model looking forward, we would anchor you to the price point in Q4 2021. We do think that is a sustainable price point that reflects both the reset in pricing in Germany as well as a sustainable price point for the U.S. And that's what we would have you inked into moving forward. The cadence and collection on these previously denied and appealed claims are really impossible to predict.
Tailwind from previously denied <unk> appeal to claims.
Look to the model looking forward, we would anchor you to the price point in Q4 2021, we do think that as a sustainable price points that reflect.
Both the reset in pricing in Germany, as well as a sustainable price point for the U S and that's what we would have you encounter them moving forward.
The cadence and collection on these previously denied in a pure Queens is really impossible to predict so we would not recommend to model it in.
With regards to your second question, we are committed to these investments and we are looking both at geographical expansion and investing in commercial infrastructure for ovarian and lung I'm actually going to pass that question to cash who is on the Kona can speak specifically to the sales force in lung.
Ashley Cordova: So we would not recommend you model it in. With regard to your second question, we are committed to these investments, and we are, you know, looking both at geographical expansion and investing in commercial infrastructure for ovarian and lung. I'm actually going to pass that question to Tesh, who's on the phone and can speak specifically to the sales force in lung.
Thanks for the question Cory So we're very excited about the possibility of planning for the new indications first one being lung I will remind you just in that we have a mesothelioma indication, where we have a team of individuals today educating on tumor treating fields with a similar.
Tesh: Thanks for the question, Corey. So, we're very excited about the possibility of planning for the new indications, the first one being lung cancer. I will remind you just in that we have a mesothelioma indication where we have a team of individuals today educating on tumor-treating fields with a similar population, target population, so to speak, that will also prescribe TT fields in lung cancer.
Population target population so to speak that will also prescribe TTP.
TT fields in lung cancer. So we have a real nice opportunity here to bridge the path between today and what's to come and in parallel we're working now on understanding the market in the U S and in other geographies and we'll make a decision on what the size of the sales force will look like in <unk>.
Tesh: So, we have a really great opportunity here to bridge the path between today and what's to come. And in parallel, we're working now on understanding the market in the U.S. and in other geographies, and we'll make a decision on what the size of the sales force will look like in context of our experience with GBM and the specific indications, lung being one of the key ones, and then subsequently the rest of our pipeline.
Next are our experience with GBM and the specific indications lung being one of the key ones and then subsequently the rest of our pipeline. So a lot of planning underway and we will look to share that as we make decisions on this front.
Tesh: So, a lot of planning underway, and we'll look to share that as we make decisions on, Okay, thank you. Our next question comes from Lei Huang with Wells Fargo. Your line is open. Hi, good morning. Thanks for taking my question. Just a quick one to start.
Okay. Thank you.
Yes.
Our next question comes from Li Wang with Wells Fargo. Your line is open.
Hi, Good morning, Thanks for taking my question just a quick one to start actually could you mention how much that.
Lei Huang: Ashley, did you mention how much that backlog collection was, the amount of it? No, we haven't given the specific breakdown. Again, I'll just reiterate that we would have you look to that Q4 baseline in 2021 as a reasonable baseline for the fundamental. Okay, but you're not disclosing or quantifying the amount of the collection, the backlog collection. Correct.
Backlog collection was that the amount of that.
No we haven't given a specific breakdown again I'll just reiterate that we would have you look to that Q4 baseline in 2021 is that as a reasonable baseline for the fundamental business.
Okay, but youre not disclosing quantifying the amount of the collection the backlog collection.
Correct Okay.
Ashley Cordova: Okay. And then just on Xylab, you mentioned that the gross margin was better because of lower purchases there. I assume that has to do with the lockdowns in China. Is it a delay in new patient starts, or are current patients not receiving therapy? I would actually, Lei, time our Q1 more to just traditional launch trajectories.
And then just on <unk>, you mentioned that the gross margin was better because of lower purchases that I assume that has to do with the lockdowns in China.
Is it a day.
And new patient starts or our current patients not receiving therapy.
I would actually way I would time, our Q1 more to just traditional launch trajectories remember we are their supplier and as they look at just distribution across the country I would not tie it to the impact of Lockdowns in Q1, and then specifically to the impact of Lockdowns in Q1, we're going to have to ask you to go to XI with that question.
Lei Huang: Remember, we are their supplier, and as they look at just distribution across their country, I would not tie it to the impact of lockdowns in Q1, and then specifically to the impact of lockdowns in Q1, we're going to have to ask you to go to Xi with that question. Fair enough, and then just on your guidance, the two to 5%, that was 3% for patient growth. It was 3% in Q1. Would you point to kind of the midpoint of that range for the year, or anything you can talk about in terms of the low versus high end of the range? Thanks. Yeah, I know it.
Fair enough and then just on your guidance, the 2% to 5% I was 3%.
For patient growth was 3% in Q1 would you point to kind of the midpoint of that range for the year or anything you can talk about in terms of low versus high end of the range.
Ashley Cordova: Thanks for the question. There's nothing that we're pointing to other than reiteration of that 2-5% range at this point. Our next question comes from Jason Bednar with Piper Sandler. Your line is open. Hey, good morning, everyone.
Yes, no. Thanks for the question there is nothing that we're pointing to other than reiteration of that 2% to 5% range at this point.
Our next question comes from Jason Bednar with Piper Sandler Your line is open.
Hey, good morning, everyone.
Jason Bednar: You know, Billy, I just want to start on some of the clinical side here. Maybe with MED-IS, I believe you can see the total patient enrollment figures. Can you talk about how close we are to full enrollment there?
Bill I just wanted to start on sort of.
Or at least the clinical side here maybe.
Maybe with.
With meadows.
I believe you can see the total patient enrollment figures.
Can you talk about how close we are in full enrollment there I mean I can see the commentary that I expected last patient in this year, but.
Jason Bednar: I mean, I can see the commentary that, you know, expecting the last patient this year, but I'm just kind of curious, you know, what inning we're in or, you know, how close to the finish line we are. And then can you give us a sense on where things stand as well with keynote B36? Sure.
Just kind of curious what inning, we're in or how close to the finish line we are.
And then can you give us a sense on where things stand as well with keynote <unk> <unk> 36.
Bill Doyle: So, first of all, we'll just continue with the guidance that we expect to complete the enrollment of MEDIS by year end. We don't traditionally give breakdowns beyond the target completion date. And with respect to our partnership trial with Merck in non-small cell lung cancer, we are actively screening patients now, and that trial is proceeding.
Sure so.
First of all we will just continue with the guidance that we expect to complete the enrollment of met us by year end, we we don't traditionally give.
Breakdowns beyond the target completion date, and with respect to our partnership trial with Merck.
In in non small cell lung cancer, we are actively screening patients now.
And.
That trial was proceeding.
Okay.
Alright, So I guess I appreciate all the irons in the fire in the clinical side.
Bill Doyle: Okay, all right. So I guess I appreciate all the irons in the fire on the clinical side, but is there timing we should have in mind, Bill, when protocols could be available for phase three and advanced liver cancer, next steps with maybe Keytruda plus TT fields and GBM? I guess I'm just trying to get a sense of whether you're confident we'll see additional building of that late stage clinical pipeline here in 2022, now that we've had some of your other phase threes actually reach LPI now. So you're right, we have lots of irons in the fire.
But is there a timing we should have in mind bill.
When protocols could be available for the phase III in advanced liver cancer next steps with Keytruda.
<unk> plus TT fields in GBM, I guess I'm, just trying to get a sense of.
Whether you are confident we'll see additional building of that late stage clinical pipeline here in 2022 now that we've had some of your other.
Phase III is actually reached LTI now.
So youre right, we have lots of irons in the fire. That's one of the great privileges of working with.
Bill Doyle: It's one of the great privileges of working with the Tumor Treating Fields Platform, and I appreciate your focus on the next wave of clinical trials and clinical opportunities. We haven't provided any timing for the release of protocols, but rest assured, we are actively working on those protocols.
With the tumor treating fields platform.
And I appreciate your focus on the next wave.
Wave of clinical trials and clinical opportunities.
We haven't provided any timing on the release of protocols, but rest assured we are actively.
Working on those protocols were in discussions with key opinion leaders and with regulators.
Bill Doyle: We're in discussions with key opinion leaders and with regulators. And as we have done previously, when we have a trial that's fully baked, we'll share the protocol. Okay, all right, fair enough. Ashley, one for you.
And as we have done previously when when we have.
A trial, that's fully baked will share the protocol.
Okay, Alright fair enough actually one one for you.
Jason Bednar: I wanted to ask about currency, and I think this shows up in how you recognize revenue per patient. But you're suggesting revenue per patient going forward should be about the same. So at least that's where we finished at the end of last year.
I wanted to ask on currency and I think this shows up in how you recognize revenue per patient.
But youre, suggesting revenue per patient going forward should be about the same.
So at least where we finished the end of last year. So I guess I'm just trying to square these points to make sure. We're all reflecting this appropriately in our model.
Ashley Cordova: So I guess I'm just trying to square these points, make sure we're all reflecting this appropriately in our models. And then, is there anything you have at your disposal to offset these FX challenges that are going on right now in Europe and Japan? Yeah, so I would say FX, while it's certainly, you know, we're not immune to it, is not a big driver of those fluctuations. But it does impact Japan more than any other market when you look at that calculation.
And then is there anything you have at your disposal to offset these FX challenges that are going on right now.
In Europe and Japan.
Yeah, So I would say FX, while it certainly we're not immune to it is not a big driver of those fluctuations it does impact Japan more than any other market. When you look at that calculation, but the impact in Europe that you look at from Q4 is has more to do with our implementation of the GBA defined coverage criteria and those contract negotiations.
Jason Bednar: But the impact in Europe that you look at from Q4 has more to do with our implementation of the GBA-defined coverage criteria and those contract negotiations. And so that's why we're having you anchor towards the Q4 price point. That reflects the impact of those pricing negotiations in Germany, as well as the sustainable business in the U.S. And so, you know, that's just what I would reiterate, that for a forward-looking model, given the impossibility of predicting the kind of tailwinds from H claims in the U.S., we would anchor to that Q4 price.
And so that's why we're having you anchor towards the Q4 price point that reflects the impact of those pricing negotiations in Germany as well as a sustainable.
Business in the U S and so.
That's just what I would reiterate that for our forward looking model given the impossibility to predict the kind of tailwind from H claims in the U S. We would anchor to that Q4 price.
Jason Bednar: Sorry, just to come back, I didn't mean to cut you off there, but just to come back, I mean, Japan took a step down, it looks like, in one cue, as far as revenue per patient. And just given the recent moves here, even since the end of the quarter, it would seem like maybe another step down is warranted. So, again, I want to make sure we're all modeling this appropriately and making sure that's consistent with how you see it. Yeah, no, I appreciate it.
And obviously I guess sorry.
And sorry, just to come back and then do you mean to cut you off there, but just to come back I mean, Japan. It took a step down it looks like in <unk> as far as revenue per patient.
And just given the recent moves here, even since the end of the quarter. It would seem like maybe another step down as warranted. So.
I don't want to make sure we're all modeling this appropriately.
Making sure that's consistent with how you see it.
Yes, no I appreciate it I would say I wouldn't I would still anchored to that Q4 price, Jason I think theres, a little bit of noise in kind of timing.
Ashley Cordova: I would say I would still anchor to that Q4 price, Jason. I think there's a little bit of noise and kind of timing of array orders from the distribution model in Japan in the Q1 number, so I would not be too concerned about overlaying an FX rate in there beyond what you see in the fourth quarter price.
Array orders from the distribution model in Japan in the Q1 number I would not I would not be too concerned about overlaying in FX in there beyond what you see in the fourth quarter.
Okay, Alright fair enough. Thank you.
Jason Bednar: Okay. All right. Fair enough.
Our next question comes from Greg Fraser with tourists Securities. Your line is open.
Operator: Thank you. Our next question comes from Greg Fraser with Truer Securities. Your line is open.
Good morning, folks and thanks for taking the questions.
Greg Fraser: Good morning, folks, and thanks for taking the questions. For GBM, how does penetration in the key academic institutions compare with the overall patient penetration of roughly 35%? Yeah, thank you for that question. So what I would say is we don't break out penetration by sites. So those that are academic centers or those that are non-academic, I think in the US, our average penetration is around 40%.
For GBM.
Penetration in the key academic institutions compared with the overall patient penetration of roughly 35%.
Yes. Thank you for that question. So what I would say is we don't break out penetration by sites. So those that are academic centers or those that are non academic I think in the U S. We are.
Average penetration is around 40%. So it's generally out of 10 GBM patients for have access to tumor treating fields and this is what you've heard us say and reiterate over and over again that our work is not done in GBM, because we believe that all six of those remaining patients should have access to tumor treating.
Pritesh Shah: So generally, out of 10 GBM patients, 4 have access to tumor treating fields. And this is what you've heard us say and reiterate over and over again, that our work is not done in GBM because we believe that all 6 of those remaining patients should have access to tumor treating fields. And that's where our focus is on working with the academic centers, particularly on the clinical development front that you've heard about in the past, and some of the things that you heard Bill talk about earlier on the clinical trial front.
Yields and Thats, where our focus is and working with the academic centers, particularly on the clinical development front that <unk> heard about in the past and some of the things that you heard bill talk about earlier on the clinical trial.
Got it okay.
Pritesh Shah: For academic institutions where Optune hasn't gotten traction, is skepticism about efficacy due to the lack of a sham device in the F-14 something that you still hear about, and if so, how do you address that?
The academic institutions were up toone hasn't gotten traction is skepticism on efficacy due to the lack of a sham device and yet <unk> something that you still hear about and if so how do you address that view.
Yes, I can speak to that as well and then.
Pritesh Shah: I can speak to that as well, and then we'll see if you have any further questions on that. So, what I would say is we hear about it less and less now as we are out there educating on the actual clinical profile of Optune in GBM, and we have now vast experience of patients that are benefiting from treatment, getting long-term quality survival benefit. We're hearing less and less about the sham control.
We'll see if you have any further questions on that so what I would say is we hear about it less and less now as we are out there educating on the actual clinical profile of opportune in GBM and we have now vast experience with patients that are benefiting on treatment getting long term quality survival benefit we're hearing less and less.
The Sham control, we have many other trials that the sites are participating in like the trade in study with radiation and in radiation. There is the sham control is not something that is done in radiation type studies. So we're seeing that sort of objection dissipate and our ability.
Pritesh Shah: We have many other trials that the sites are participating in, like the Trident study with radiation, and in radiation, the sham control is not something that is done in radiation type studies. So we're seeing that sort of objection dissipate, and our ability now to march towards standard of care status really hinges upon the clinical data that we've generated and the patient experience that we can speak to. As you heard, again, Bill talked about one of the patients that we highlighted in the preliminary comments of this call. Great, that's helpful.
Now to March towards standard of care status is really hinges upon the clinical data that we've generated and the patient experience that we can speak to as you heard about again Bill talk about one of the patients that we highlighted in.
Yes.
Preliminary comments of this call.
Great. That's helpful. How much overlap is there between the academic centers that have adopted <unk> for GBM and those participating in your other phase III trials.
Pritesh Shah: How much overlap is there between the academic centers that have adopted Optune for GBM and those participating in your other phase three trials? So I'll start this, and I'll ask Elie Benin, who's our chief medical officer, to chime in if there's anything else to add. What I would say is that our focus is on the large institutions.
So I'll start this and I'll ask <unk> who's our chief Medical officer to chime in if there's anything else to add what I would say is our focus is on the large institutions. We know that that's where a large number of GBM patients are treated so we want them to <unk>.
Pritesh Shah: We know that that's where a large number of GBM patients are treated. So we want them to participate in generating additional clinical evidence. And so our focus will be on involving KOLs from those key centers and making sure that not only do they get to participate in the study, but they get to build additional evidence with other sort of modalities that they're interested in combining with tumor treating fields. And this way, it becomes a win-win proposition and allows us to ensure that TT fields and Optune get further incorporated into their clinical practice.
Participate in generating additional clinical evidence and so our focus will be on involving kols from those key centers and making sure that not only do they get to participate in the study, but they get to build additional evidence with others sort of modality that theyre interested in combining with tumor treating fields and this way it.
The win win proposition and it allows us to ensure that <unk> is an opportunity to get further incorporated into into their clinical practice and again as we march towards standard of care status.
Pritesh Shah: And again, as we march towards standard of care status. Hi Greg, I would like to add that, You know, the GBM always or obviously is an entry for us in many places academically, because then the organization institution is used to it. The nurses are used to patients see each other and say, what is that somebody is wearing?
Yes.
Greg I would like to add that.
The GBM always or obviously its an entry for us in many places academically because then they organization institution is used to the nurse's I used to patient see each other and say what is dead and somebody is wearing.
Elie Benin: So we do have that opportunity, and we use it. I would just like to add that, you know, on the comment about engaging these sites, we have a very robust, as we've mentioned, IST program, and we have sites like Stanford, UPenn, MD Anderson, Mayo Clinic, et cetera, that are participating in this study. So it's not that we don't have penetration in these groups.
So we do have.
That opportunity and we use it I would just like to add that.
On the comment about engaging these sites. So we have a very.
Robust we've mentioned ICT program.
We have.
So I'd say like Stanford Upenn, MD Anderson Mayo clinic et cetera that are participating in this study so it's not that we've done.
Penetration in.
And this groups and most of them are GBM, but also in the new indications.
Elie Benin: And most of them are GBM, but also in the new indications. Pritesh mentioned the Trident study that is going well. And we keep having patients in this study. And I want to make a comment on on the acceptance of tumor treating fields. You know, we we present a lot of medical congresses, a lot, you know, Snow, Asteroids and others. And you have to remember that all these medical congress presentations are reviewed by our peers from these, top institutions, and they decide who is going to present and why are they going to present.
<unk> mentioned the Triton study.
It's going well and we keep having.
Having patients in this study and I Wonder if you could comment on.
On the acceptance of tumor treating fields.
We present on Lauder medical Congresses, Allot, snow asteroids, and others and you have to remember that all these medical Congress presentations are reviewed by our peers from these top institutions very good they decide who's going to percent why are they going to percent.
And since I joined Novo came before that every year, we're just percent more and more in all these medical Congress. It. So I think this is a sign of the acceptance more and more in the scientific.
Elie Benin: And since I joined Novocure and before that, every year we just present more and more in all these medical conferences. So I think this is a sign of acceptance more and more in the scientific community. Got it.
Community.
Got it thanks for taking the questions.
Greg Fraser: Thanks for taking the question. As a reminder, to ask a question, please press star then 1. Our next question comes from Jason Witz with Loop Capital. Your line is open.
As a reminder to ask a question. Please press Star then one.
Our next question comes from Jason Wittes with loop capital. Your line is open.
Jason Witz: Hi, thanks for taking the questions. In terms of the Higher Powered Array that's coming out at the end of the year, what clinical data is going to be behind it? And also, if you could, what clinical data do you have available now that we could look at relating to that? So, Jason.
Hi, Thanks for taking the questions.
In terms of the higher powered array that's coming out the end of the year.
Clinical data is going to be behind it and also if you could what clinical data do you have available now that we could look at relating to that.
So.
Hi, Jason so.
Bill Doyle: So, We've discussed for now a number of years the benefits of increased dose. And if we go back to the EF-14 phase three trial in GBM and subsequent data that was published in the Red Journal by Professor Balow and his colleagues, I think that's where I would point you to, to take a look at that. It's absolutely clear that the patients in EF-14 who.., had tumors in the regions that had the highest exposure to tumor-treating fields, had the longest survivals in that trial. And this comes on top of years of preclinical research that demonstrate the dose dependence of the FDA. Yeah, no, thank you. That's fair.
We've discussed.
For now a number of years.
The benefits of increased dose.
And if we go back to the F 14 phase III trial in GBM and.
Subsequent.
Data that was published in the Red Journal by Professor Belo and his colleagues I think that's where I would point you to.
Take a look at that it's absolutely clear that the patients in.
F 14, who.
Had tumors in the regions that have the highest exposure to tumor treating fields had the longest survivals in that trial.
And this comes on top of years of preclinical research.
It demonstrates the dose dependence of the of the efficacy.
Okay.
Yes, that's.
Jason Witz: I was just wondering, I think the dose response has been well documented and is well accepted, especially amongst some of the physicians I've spoken to. But I'm just curious in terms of whether we can anticipate there'll be any additional clinical data supporting that with the higher power to raise when you have the European limited launch, and if we can expect any further clinical trials relating to that going forward. Yes, so we do have our EF-33 Phase II trial using a first-generation high-intensity array, and we do expect final data from that trial later this year.
Thats Fair I was just I think the dose.
Sponsors has been well documented and I think.
Well accepted.
Especially amongst some of the some of the physicians I've spoken to.
I'm just curious in terms of.
Whether we can anticipate there'll be any additional clinical data supporting that with the higher power to raise when you have the European limited launch.
And if we can expect any other further clinical trials relating to that going forward yes.
Yes, so we do have our E F 33.
Phase two trial using a first generation.
High intensity array.
Bill Doyle: I'd say that's going to be an indication and just the first piece of data, and then we will continue to develop clinical evidence with the newer, specific arrays. And one of the things that we're very excited about and have been for many years, but now that we have the financial resources to really invest in product development, we see a cycle of potential product improvements coming, specifically in the arrays, but also in the field generator and in the software that we provide both to patients to monitor their compliance and to doctors to position the array. So there's a lot of exciting things coming in product development. Okay, thank you, that's helpful.
And we do expect final data from that trial later this year, let's say that's going to be an indication and just the first.
Piece of data and then we will continue to develop.
Clinical evidence with the new the specific new arrays and one of the things that we're very excited about.
<unk> have been.
For many years, but now that we have the financial resources to really invest in product development.
We see a cadence of potential product improvements coming.
Specifically in the raise but also in the in the field generator and in the software that.
We provide both to patients to monitor their compliance and to doctors to position the arrays. So theres a lot of exciting things coming in the product development front.
Jason Witz: And then, you guys have had a very, I would say, successful track record in terms of having Phase IIs come out successfully. Curious, should we assume for gastric that if that's a successful trial, that can lead directly to the initiation of a new Phase III? And related to that, are there any other Phase III pivotal trials that we might see initiated this year that you're planning? Sure, so with respect to your first question, the reason, of course, that we go into a phase two program is to dial in parameters that will lead to a phase three program.
Thank you that's helpful. And then you guys have had a very.
Successful track record in terms of having phase twos come out come out successfully.
I'm curious should we assume for gastric that.
Is it a successful trial that can lead directly to initiation of a new phase III and related to that.
Are there any other phase III pivotal trials that we might see initiated this year.
That you are planning.
Sure. So with respect to your first question. The reason of course that we go into a phase III program.
Is.
To dial in parameters.
That will lead to a phase III program and again if were.
Bill Doyle: And, you know, again, if we're, and we take a look at the data, we've described this process before, we look at all the parameters, we look at the patient populations, and we will share the data and our analyses with you later this year. If it looks good, we will have a phase three program. In terms of other phase twos, I can tell you there's a lot in planning. And as I've said earlier in the call, when the details are fully determined, we'll do appropriate analysis. Good
When we take a look at the data with describe this process before we look at all of the parameters, we look at the patient populations.
And we will share.
The data in our analysis with you.
Later this year.
Yeah.
Looks good we will have a phase III program in terms of other.
Phase II is I can tell you theres a lot in planning.
And as I've said earlier in the call when the when the details are fully determined we will make appropriate announcements.
Great. Thank you very helpful I'll jump back in queue.
Okay.
Our next question comes from Vijay Kumar with Evercore ISI. Your line is open.
Jason Witz: Thank you. Very helpful. I'll jump back in queue. Our next question comes from Vijay Kumar with Evercore ISI. Your line is open. Hi, this is Lily on behalf of Vijay.
Hi, This is Willie answer thanks for taking my question.
Lily: Thanks for taking my question. One, on R&D spend, I know it can fluctuate, but it was down this quarter. I was wondering if you could give color on the ramp or cadence for R&D spend for the rest of the year? And then two, was there a revenue impact from reimbursement negotiations in Germany this quarter? And have you quantified this?
One on R&D spend I know to fluctuate, but it was down this quarter I was wondering if you could give color on the ramp of our cadence for R&D spend for the rest of the year and then Q was there a revenue impact from reimbursement negotiations in Germany. This quarter and have you quantified that thank you.
Ashley Cordova: Thank you. Lily, thank you for those questions, and I'll address both specifically. So from an R&D perspective, we continue to invest aggressively in R&D, and as I noted before, this can fluctuate by quarter of a quarter depending on the timing of direct clinical trial expenses, but I would really look to the full year 2021 number and then expect us to continue to grow off of that base as we just have increasing clinical trial investments as the pipeline expands. So that's how I would think about R&D.
Thank you for those questions and I'll address that specifically so from an R&D perspective, we continue to invest aggressively in R&D and as I noted before this can fluctuate quarter over quarter, depending on the timing of direct clinical trial expenses, but I would really look to the full year 2002.
One number and then expect us to continue to grow off of that base as we just have increasing clinical trial.
Investments has the pipeline expand so that's how I would think about R&D specific to the revenue number yes, we will have an impact on a go forward basis from the pricing negotiations in Germany, and Thats why again I'll reiterate we would have everybody look to the fourth quarter 2021 price point and Thats, what we would recommend you carryforward.
Ashley Cordova: Specific to the revenue number, yes, we will have an impact on our go-for basis from the pricing negotiations in Germany, and that's why, again, our reiterated, we would have everybody look to the fourth quarter 2021 price point, and that's what we would recommend you, Terry. Thank you. Our next question comes from Kevin DeJeter with Oppenheimer. Your line is open.
Thank you.
Our next question comes from Kevin <unk> with Oppenheimer. Your line is open.
Hey, thanks for taking our questions.
Kevin DeJeter: Hey, thanks for taking our questions. I appreciate the comments with regard to... clinician access, you know, as we begin the reopening process, you know, as COVID recedes in many markets, but can you kind of comment where you are currently in the US and perhaps in Germany with regard to, you know, clinician inside access, you know, maybe using pre-COVID levels as a baseline and, you know, how we should think about those trends perhaps through the balance of the year.
I appreciate the comments with regard to.
Clinician access.
As we begin the reopening process.
Receipts in many markets, but can you kind of comment where you are currently in the U S and perhaps in Germany with regard to.
Clinician inside access.
Maybe using pre COVID-19 levels as a baseline.
And how we should think about those trends, perhaps through the balance of the year.
Yes. Thank you. Thank you for that question. So what I would start off with is in Q1, particularly given the impact of the <unk> variant we saw challenges both in accessing physicians as a result of the impact of the variant. We also saw staffing changes, which has a big impact on <unk>.
Kevin DeJeter: Yes, thank you for that question. So, what I would start off with is in Q1, particularly given the impact of the Omicron variant, we saw challenges both in accessing physicians as a result of the impact of the variant; we also saw staffing changes, which had a big impact on how we interface on the education front with clinicians, patients' ability to get education, and then, of course, internal field team challenges. Our internal team was impacted by the Omicron variant as well.
How we interface on the education front with clinicians patients' ability to get education, and then of course internal field team challenges are.
Kevin DeJeter: The good news is we saw recovery from this coming out of the last month of the quarter, and as we now start to see the rest of the year unfold, unfortunately, COVID has been one of those waxing and waning aspects of how we conduct business, but we are encouraged by how we can continue the education with the ability to see physicians face-to-face, having access to their support staff that interfaces with patients face-to-face, and that's We're doing everything we can to make sure that our message gets out and patients get support as they're thinking about our therapy. Great, no, I appreciate that.
Team impacted by the Omicron Varian as well the good news is we saw recovery from this coming out of the last month in the quarter and as we now start to see the rest of the year unfold unfortunate Covid has been one of those waxing and waning aspects to how we conduct business, but we are encouraged.
By how we can continue the education with the ability to see physicians face to face having access to their <unk>.
Support staff that interfaces with patient face to face and that's the premise that we're operating in we are doing everything we can to make sure that our message gets out and patients get support as they are thinking about our therapy.
Great No I appreciate that and then maybe just returning to the update on.
Kevin DeJeter: And then maybe just returning to the update on reimbursement for France. As we think about the 2022 guide, should we anticipate any of the put and take on the revenue side being impacted by, you know, the timing of that decision in France? Or is that really a 2023 opportunity from a revenue perspective?
Reimbursement for France as we.
Think about the 2022 guide should we anticipate any of the put and take.
On the revenue side being impacted by.
Timing of that decision in France or is that really a 2023 opportunity from a revenue perspective.
Ashley Cordova: Yeah, so I'll just reiterate, thanks for that, Kevin, that we are on track in France and we do expect to finalize pricing negotiations and start treating patients later this year. You know, there is always a bit of a ramp-up as to when that will flow through revenue from a 606 perspective, so I would say materially that we would expect a launch, we would expect active patient participation, and it will begin to contribute materially to revenue in future years. Thanks for taking our questions. That concludes the question and answer session. I'd like to turn the call back over to Bill Doyle for any closing remarks.
Yes, so I'll just reiterate thanks for that Kevin that we are on track.
France, and we do expect to finalize pricing negotiations and can start to treat patient patients later this year.
There is always a bit of a ramp up as to when that will flow through revenue from asics for a second so I would say materially we would expect to launch we would expect active patient participation and it will begin to contribute materially to revenue in future years.
Thanks for taking our questions.
That concludes the question and answer session I'd like to turn the call back over to Bill Doyle for any closing remarks.
Bill Doyle: So, I'd like to thank everyone on the phone who joined us this morning for your interest and continued support of Novocure. I'd also like to particularly thank all the Novocure team members who are on the line for your dedication to our mission. This has obviously been a challenging two and a half years, and your dedication to serving patients is why this is such a special company. We're entering a transformational period for Novocure, with multiple clinical catalysts on the horizon, as well as product enhancements that will reach patients later this year. Our GBM business continues to grow, and we are expanding our commercial footprint. The fundamentals of our business remain strong, and we look forward to updating you on progress throughout the year.
So I'd like to thank everyone on the phone.
Operator: This concludes the program. You may now disconnect. Everyone, have a great day. [music]
Who joined US this morning.
For your interest and continued support of <unk> I would also like to particularly thank all the Novocure team members who are on the line.
For your dedication to our mission.
This is obviously.
In a challenging.
Two and a half years and your dedication to serving patients is.
Why this is such a special company.
We're entering a transformational period for Novocure with multiple clinical catalysts on the horizon as well as product enhancements that will reach patients later this year, our GBM business continues to grow and we are expanding our commercial footprint.
London metals of our business remains strong and we look forward to updating you on progress throughout the year.
This concludes the program you may now disconnect everyone have a great day.
Okay.
[music].