Q1 2025 Novocure Ltd Earnings Call
Dr. J.
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Speaker Change: Good day and thank you for standing by. Welcome to the Novocure First Quarter 2025 earnings call. At this time, all participants aren't a listen-only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. Please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand the conference over to your host for today's conference, Ingrid Goldberg, please go ahead.
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Speaker Change: Good morning, and thank you for joining us to review Novocure's first quarter of 2025 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle, CEO , Asaf Cordova, and TFO Christoph Brackmann. Other members of our leadership team will be available for Q&A.
Speaker Change: For your reference, slide the company this earnings release can be found on our website www.novocure.com on the Investrelations page under quarterly reports
Before we start, I would like to remind you [inaudible]
Speaker Change: But our discussions during this conference call will include forward-looking statements and actual results could differ materially from those projected in these statements.
Speaker Change: These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC violence. We do not intend to update publicly any four-looking statement except as required by law.
Speaker Change: Where appropriate, we refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earning, before interest, taxes, depreciation, amortization [inaudible]
Speaker Change: We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items and best reflects the financial value generated by our business.
Speaker Change: Reconciliation of non-gap-to- GAAP financial measures are included in our press release, earning slides, and in our form 10Q file with the SEC today. These materials can also be accessed from the Investor Relations page of our website.
Speaker Change: Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our executive chairman Bill Doyle
Thank you, Ingrid, and good morning [inaudible]
Speaker Change: For 25 years, our mission at Novocure has been to extend survival for patients with some of the most aggressive forms of cancer through the development and commercialization of tumor treating fields.
2025 is set to be a defining year for Novocure.
Speaker Change: As we move from a single indication, treating patients with GBM to becoming a multi-indication oncology company
Speaker Change: With five successful phase three clinical trials in hand, our focus is squarely on execution.
particularly on the regulatory and commercial fronts.
Speaker Change: This morning, we will discuss early feedback from our non-smoke cell lung cancer launch.
Speaker Change: Provide commercial and clinical pipeline updates, and then turn to our quarterly financial performance.
Speaker Change: But before we dive into the quarterly update, I would like to highlight two items of breaking news.
Speaker Change: On Tuesday morning, we announced that Octun Lua received European CE Mark approval for the treatment of metastatic non-small cell lung cancer.
Speaker Change: We were pleased to receive a broad label, which includes concomitant treatment with both immune checkpoint inhibitors or DOSA taxa [inaudible]
Speaker Change: Our team in Germany is ready to launch pending local registration
Speaker Change: Also, we were pleased to announce yesterday that the results of our Panova 3
Speaker Change: Our successful Phase III clinical trial in unresectable, locally advanced pancreatic cancer were accepted for presentation at the upcoming American Society of Clinical Oncology Annual Meeting.
Speaker Change: Data from the Pinova 3 trial will be presented on Saturday, May 31 by Lead Investigator Dr. Vincent Pacosi of the Virginia Mason Medical Center, as part of the Gastrointestinal Cancer Oral Abstract Clinical Session.
Speaker Change: That evening, at 7 p.m. Central Time, we plan to host an investor event with a live webcast to dive into the results with Dr. Prakowzi and members of our management team.
Thank you for watching!
Speaker Change: Pancreatic Cancer is one of the deadliest forms of cancer with an estimated five-year survival rate of only 13% and a growing global incidence.
Speaker Change: Pinover 3 is the first and only Phase 3 trial to demonstrate a meaningful survival benefit in locally advanced pancreatic cancer.
Speaker Change: Presentation of the Penova 3 data on the main stage at ASCO will bring important visibility to the potential for tumor treating fields to meaningfully bend the survival curve in pancreatic
Speaker Change: We look forward to discussing the Penova three results with clinicians and investors next month.
Speaker Change: I'll now turn the call over to Ashley to provide further updates on Q1.
Thank you, Bill.
Ashley Cordova: It has been an exciting quarter for our team, and I am proud of the milestones we've hit already this year.
Ashley Cordova: Our mission has never felt more urgent, as we expand our reach to more patients facing some of the most challenging solid tumors with significant unmet need.
Ashley Cordova: Last October , we received PMA approval for Optumlua and our newest indication, Medisatic Non-Solcellone Cancer, and immediately initiated our U.S. launch.
Ashley Cordova: After a strong start, we remain highly encouraged by the early commercial indicators
Ashley Cordova: In the first quarter we received 92 non-swall cell on cancer prescriptions and ended the period with 62 patients on therapy
Ashley Cordova: We also had 44 Mississippi Omen patients on therapy for a total of 106 Up to Nua active patients.
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Ashley Cordova: These early results in non-flossal lung cancer reflect our focus and disciplined launch strategy centered on reaching the right position for the right patient at the right time.
Ashley Cordova: Our initial efforts have concentrated on engaging physicians most likely to adopt Optumua.
Ashley Cordova: Those open to novel treatment modalities and eager to engage with us in advancing patient care
Ashley Cordova: Many of these physicians operate in community settings, where the majority of non-sposal lung cancer patients are treated.
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Ashley Cordova: We're seeing encouraging breadth in prescriber interest. As of March 31st, we have received prescriptions from 93 unique prescribers.
With 60% of these prescribers new to tumor treating field therapy.
Ashley Cordova: Many come from institutions that have never prescribed Optune Geo for JBM.
Ashley Cordova: General Medical Oncologists represent the largest share of prescribers and radiation oncologists are emerging as important users and advocates.
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Ashley Cordova: RFDA Label enables patients to use Optumlua together with either a checkpoint inhibitor or dosa-taxful, following progression after prior exposure to platinum chemotherapy.
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This aligns well with real-world treatment patterns.
Ashley Cordova: While newer biomarker-specific therapies dominate headlines, only about 30 percent of lung cancer patients qualify for these options.
Ashley Cordova: Most patients receive a platinum chemo plus an immune checkpoint inhibitor in the first line, positioning them squarely within our on-label population.
Thank you for watching!
We see three primary patient populations driving early adoption.
Ashley Cordova: First, there are those patients who responded to first-line ICI and platinum chemo, but show early signs of relapse [inaudible]
Ashley Cordova: This is the smoldering progressive population we have referenced in the past.
Ashley Cordova: 2. Our patients who received ICI and platinum chemo on the first line but who did not respond have progressed and are motivated to seek second line treatment for rapidly progressing disease.
Thank you for watching!
Ashley Cordova: Finally, there are low or non-PD-L1 expressors that received platinum-based chemo as monotherapy in the first line, have progressed, and are looking for a better alternative to long-term chemo monotherapy.
Ashley Cordova: Each of these groups represent sizable patient populations with limited treatment options prior to the launch of Optin Lua. Combined, we believe these groups represent approximately 30,000 eligible patients in the US annually.
Encouragingly, our early adoption includes patients from all three populations [inaudible] from all three populations
Ashley Cordova: Of the 62 non-false 11 cancer active patients on therapy at quarter end, there was roughly a 50-50 split between consummate in ICI and Dr. Taksaw you.
Ashley Cordova: As of March 31st, over 90% of the patients who were prescribed optumula were previously treated with an immune checkpoint inhibitor, a clear indicator that physicians are comfortable with continued ICI treatment in the second line.
Ashley Cordova: Beyond reaching the right positions and the right patience, our third focus for launch success is treating patients at the right time.
Speaker Change: Starting up to Mua at first find a progression and minimizing use as a salvage therapy
Speaker Change: Through the end of Q1, approximately 50% of the prescriptions received were for Optumua in second line use, with another 25% prescribed for third line use.
Thank you for watching!
Speaker Change: As Bill mentioned, earlier this week, we were thrilled to announce CE Mark approval for the treatment and metastatic non-salsa lung cancer in European markets.
Speaker Change: Our team is launch ready. As a reminder, we have an Optumua Sales Force in place in Germany that has been detailing Optumua for Mrs. Yoyoma over the prior year in preparation for the non-salsa launch.
Speaker Change: We have initiated the local registration process in Germany and are preparing to launch
Speaker Change: This is an important milestone and we are excited to add a second market to drive up to Mula Grove.
Thank you for watching!
Looking ahead, regulatory review is ongoing and constructive in Japan.
Speaker Change: We begun building out our Japanese commercial team in anticipation of a launch in Japan later this year.
[inaudible]
Speaker Change: We remain confident in our ability to expand access and drive top line growth in the coming years as momentum builds across clinical, commercial and payer communities.
Turning to our bedrock GBM business
Speaker Change: Q1 performance was strong with a record 4162 active patients globally.
Speaker Change: We saw continued year-over-year patients grow, particularly in France and Japan.
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Speaker Change: Our GBM Business serves as an important springboard for product and service enhancement that will be leveraged across future indication.
Speaker Change: The most recent example is the rollout of the HSE array, which is now standard for all new GBM patients in all active markets.
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Speaker Change: While the HFE array is designed for head applications, feedback from patients and caregivers on the new materials and design elements will be invaluable in the design of our next generation torso and abdominal arrays.
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Speaker Change: We also recently launched a patient app available on both the iTunes app store and Google Play.
Speaker Change: Our app is an exciting advance for patients as it allows them to follow their individual daily usage rates, order new supplies at the touch of a button, and troubleshoot any issues with the device.
Speaker Change: We recently cleared 1,400 app users in the U.S. representing a significant portion of the 2100 plus U.S. Activation.
Speaker Change: Next, generations of the app with greater functionality and international access are in the design phase now
Speaker Change: Personal app-based tools not only improve the patient experience, they also set the stage for scalable, high-touch services as we enter a multi-indication feature
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Speaker Change: Turning to Regulatory Catalyst, PMA Submissions provoked Metis and Penova 3 remain on track for 2025.
Speaker Change: Our modular PMA shell for the meta-application has been approved by the FDA. Modules 1 and 2 were submitted earlier this month and are now under FDA review.
Speaker Change: We are also making steady progress towards submission of a PMA for locally advanced pancreatic cancer based on the Penova 3 data, including active pre-submission engagement with the FDA.
Speaker Change: These early discussions are helping shape the structure and content of our formal filing and will support a smooth review process.
Thank you for watching!
Speaker Change: On the clinical front, we are focused on studying applications of tumor treating fields that could further expand our addressable markets in pancreatic and lung cancers, maximize duration of therapy, and broaden the data supporting use in GBM. Thank you very much.
Speaker Change: Our pipeline is largely focused on studying the concomitant use of tumor trading fields and immune checkpoint inhibitors, a regimen that continues to show immense promise across indications.
Speaker Change: We are opening sites and enrolling patients in our Phase 3 keynote, D58 and Lunar 2 trials, and our Phase 2 Lunar 4 trials
Speaker Change: Our Phase 3 Trident Trial and our Phase 2 Penova 4 Trial are both fully enrolled and in follow-up, with top-line data readouts expected in the first half of 2026.
Speaker Change: We believe our clinical pipeline provides us with the potential to deliver tumor-treating field therapy to tens of thousands of additional patients annually.
Thank you for watching!
Speaker Change: In summary, this is a moment of meaningful momentum for Novocure.
Speaker Change: After years serving patients in a single commercial indication, our footprint is expanding to new indications, new centers, and new physician specialties.
Speaker Change: Our lung launch is progressing. Our pipeline is advancing. And our commitment to patient-forward innovation is stronger than ever.
Speaker Change: We look forward to updating you on our progress as the year unfolds [inaudible]
Speaker Change: With that, I'll turn the call to Christoph to discuss our financial performance in the quarter [inaudible]
Thank you, Ashley.
Christoph Brackmann: 2025 is off to a strong start. In the first quarter, we generated $155 million of net revenue, an increase of 12% from the first quarter of last year [inaudible]
Christoph Brackmann: This was primarily driven by 11% growth in active patients and to a lesser extent from reimbursement improvements.
Christoph Brackmann: We grew active patients compared to prior year by 46% in France, 17% in Japan, 10% in Germany, and 4% in the US.
Christoph Brackmann: We collected $1.5 million from Optune Lua claims in the quarter, which was split roughly 50-50 between 10 p.m. and 10 at CLC.
Christoph Brackmann: It's encouraging to see the initial results of our NSCOC reimbursement efforts in the form of Approvals and Positive Outcomes from Appeals.
Christoph Brackmann: As a reminder, according to USGAP, we recognize revenue by applying our estimated future collection rate at time of billing.
Christoph Brackmann: Since NACLC is a new indication, we will need to build a collection track record to support a collection rate estimate to enable revenue recognition upon billing.
Christoph Brackmann: Until we build a track record, our revenue from non-small cell lung cancer claims will reflect cash collections in the period.
Christoph Brackmann: Or Grossmargin for the quarter was 75% compared to 76% in the prior year period.
Christoph Brackmann: The reduction of cross-margin was primarily driven by the roll-out of our HFE arrays in the NSEO C-LONs where we are treating unlabeled patients at risk prior to establishing broad reimbursement.
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Christoph Brackmann: This is consistent with discussions and prior periods and we expect these headwinds to lessen as we establish reimbursement in non small cell lung cancer and lower the cost of the new HIV arrays.
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Christoph Brackmann: Additionally, we anticipate some gross margin headwinds due to the evolving tariff landscape.
Christoph Brackmann: Our most significant exposure is from the import of a race into the US from Israel with lesser potential impacts from imports from Mexico and Europe .
Christoph Brackmann: If tariffs return to the increased rates announced before the current 90-day pause, we estimate that input youths could impact our 2025 cost of goods by up to $11 million.
Christoph Brackmann: In a scenario where this pause is extended through year end, we estimate that annual cost of goods could be impacted by up to eight million dollars.
Christoph Brackmann: We're driving several supply chain optimization initiatives to mitigate the incremental headwind from terrorists.
Moving down to P&L
Christoph Brackmann: Research and development costs for the quarter were $54 million and increase of 4% from the same period in 2024
Christoph Brackmann: We do not expect R&D expenses to take a material step up this year as we ramp down spent on some large phase three trials and ramp up spent on others.
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Christoph Brackmann: Sales and marketing expenses in the quarter were $56 million, an increase of 1% from Q1 of last year.
Christoph Brackmann: Our thoracic sales forces in the US and Germany are fully star and reflected in our Q1 operating expense.
Christoph Brackmann: Looking ahead, we expect some incremental expense primarily for marketing and in preparation for launch in additional countries.
Thank you for watching!
Christoph Brackmann: GNA expenses for the quarter were 45 million dollars, an increase of 13% from the first quarter of 2024
Christoph Brackmann: This increase was primarily due to a one-time $2.3 million expense to retire production line related to supply chain optimization efforts and personnel and professional expenses to support the NSCC launch and potential additional launches.
Christoph Brackmann: We believe our current GNA footprint can be leveraged to treat patients across multiple indications so that we would expect only modest increases in spending in the foreseeable future.
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Christoph Brackmann: Loss for the quarter was $34 million with a loss per share of 31 cents.
Christoph Brackmann: Adjusted EBITDA in the quarter was negative $5 million and our current cash and investment balance at the end of Q1 was $929 million.
Christoph Brackmann: Reaching profitability is a key focus for us as we prepare for multiple potential new product launches in the coming years.
Christoph Brackmann: While investing for growth, we are determined to keep our operating expenses measured, and we believe we can leverage many areas of our current infrastructure to meet the needs of multiple launches.
Christoph Brackmann: With a cash and short term investments currently on our balance sheet, as well as the capital available through our credit facility, we believe that we have the funds necessary to retire our convertible note you in November and bridge to new revenue streams from future indications.
Thank you for watching!
To Close [inaudible]
Speaker Change: I'd like to take a step back and reflect on my first quarter in Roll.
Speaker Change: This is an incredibly exciting time for Novocure as we pivot from a single indication to a multi indication company.
Speaker Change: Tumaturting Field Therapy has been clinically de-risked in several important cancer indications
Speaker Change: We have built a sustainable business that provides the financial strength to launch in these new indications and pursue an ambitious clinical pipeline to further expand our reach.
Speaker Change: Our infrastructure and institutional knowledge can be leveraged for growth in the coming years.
Speaker Change: We are confident in our technology, in our team, and in our ability to reach many more patients in need and rush substantial revenue growth.
Speaker Change: We look forward to updating you on our progress as we do so, and to see many of you at ASCO.
We will now turn to our operator for your questions.
Speaker Change: As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Please stand by when we compile the Q&A roster of the Q&A roster.
Our first question comes from Larry Biegelsen with Wells Fargo [inaudible]
Thank you for watching!
Speaker Change: Good morning. Thanks for taking the question. Congrats on a nice quarter here. Bill or Ashley, I wanted to ask one on non-small cell lung cancer, one on Pinover 3.
Speaker Change: So just starting with non-small cell lung cancer, we're trying to benchmark the launch to newly diagnosed GBM
Speaker Change: As obviously a benchmark, the scripts look like they're about 25% of newly diagnosed GBM scripts at the same time post-launch, active patients about two-thirds . . .
Speaker Change: How are you viewing the ramp of non-small cell lung cancer after I know only two quarters but versus newly diagnosed GBM? We're just trying to understand how big non-small cell lung cancer can be relative to GBM, any color on how you're seeing the curve so far and had one follow-up.
Thank you for watching!
Ashley Cordova: Yes, Sean Larry, this is Ashley, good to hear from you, and I'll actually add Frank to provide some color in the lunch after the answer. The short answer is it's hard to...
Speaker Change: Tyate to newly diagnosed GBM Larry, and I know that's hard because you want the analog, but it is a different setting. This is a general medical oncologist. This is an oncology community that now knows tumor treating fields because we're not launching in our first indication.
Thank you. Thank you.
Speaker Change: to be able to detail the high-defiled physicians that are prescribing an unsolvable cancer.
and I would...
You know, I know that's-
Speaker Change: Not a direct analog to newly diagnosed GBM, but I think actually our trajectory in prior quarters is the better analog and we're very pleased where this has gone post launch and through Q1 and then maybe I'll pass it to Frank Tadson color.
Frank: Yeah, hi, Larry. I'll just say that, you know, what we we set in prior quarters remains true that we see a high unmet need. This is a population that does not have a
Frank: Good treatment option and tumor treating fields is perceived as bringing clinical value to that patient population and we're seeing in the numbers that we do have 90% of the patients who have been previously treated with. [inaudible]
Frank: I mean you check point inhibitors and that, you know, again gives us real confidence that there's a big population out there to go and pursue and you're just one kind of story I'll add to give color color
Ashley Cordova: to what Ashley said about the fact that the community does at least no tumor treating field. [inaudible]
Frank: We were able to have Optumula added to the drop down ordering menu in the electronic medical record of one of the largest private practices in the US and when we did that for GBM it took us about five years to get to that point and it took us about five months in the lung cancer launch.
That's very helpful.
Frank: And then switching gears to Pinover 3, Ashley maybe helps set expectations for the presentation at ASCO
Speaker Change: You know, in addition to the overall survival curves, what dating do you think will be important to physicians such as response rate, you know, percent of patients who become surgically operable? And how are you going to address pushback from academic physicians that you use Gemma Braxane in the control arm and not full fear knocks in the control arm? Thanks.
Thank you for watching. See you next time.
Speaker Change: Great. So I would just remind everybody that we were very pleased to have our late breaking abstract accepted for oral presentation on Saturday afternoon at Asco. So this is, you know,
Speaker Change: Really prime podium time for our Pinerva 3 data set presentation.
Speaker Change: Um, and I'll just put another plug in that we are planning on hosting an investor event that Saturday evening so hope to see many of you all in Chicago in Chicago.
Speaker Change: And I think you could expect what you would always expect from the first presentation of primary data. You'll get the full data site, you'll get the full demographic breakdown, you'll see the Kaplan Meyer curves for those first time. Thank you.
Speaker Change: We know that this trial was successful. We know that we extended survival by two months, which is a meaningful extension and locally advanced pancreatic cancer and you'll see the full detail, including key secondary points presented by Dr. Pekosian's stage.
Speaker Change: You know, I think Larry, in terms of questions that we're going to get around this trial, I think there's always questions that I would say this is a very clean trial in space with significant unmet need and our engagement with the scientific
Speaker Change: Committees and with the investigators so far has been one of real excitement.
There is [inaudible]
Speaker Change: You know, it is extremely rare for a pancreatic cancer phase through trial to hit its end point and there is a lot of interest in understanding how we can use tumor treating fields both in this locally advanced setting and combination with juvenile boxing and where we can take the research from here. I would say it's, you know, we're confident that this is. [inaudible] through trial to get the research from a pancreatic cancer phase through trial
Speaker Change: A community both on the academic and commercial side that is eager to engage in the discussion on how they can extend survival for pain-created cancer and we look forward to sharing the data with everybody at Asuka.
All right, thanks so much.
Our next question comes from Jonathan Chang with Learing Partners .
Thank you for watching!
Jonathan Chang: This is you and Um for Jonathan. Thanks for taking our questions and congrats on the Pomolva 3 getting accepted just a light break here at ASCO
Speaker Change: So, our question is, how should we be thinking about the potential read-through of the positive to know with three results for the Phase II, Penovo IV, which is in the metastatic pancreatic cancer setting? And how are you thinking about the low co-versus, the semi-control GPOs and the potential mechanism? Thank you.
Speaker Change: Thanks for the question. I'm actually going to hand that over, as I always think about local versus metastatic chemicals in a minute, but it is a good reminder for everybody that we do have another data set reading out next year, the first top of next year, in metastatic pancreatic cancer, which is the combination of tumor treating fields, dermabroxane, and it has a lismab in metastatic pain, which looks at the potential to, again, extent survival when we combine with an immune checkpoint inhibitor. So we're very excited about this.
Speaker Change: Asaf Danziger, Ashley Cordova, William Doyle, Asaf Danziger, Ashley Cordova, William Doyle,
Anything you would add?
Speaker Change: Yeah, thank you, Ashley. I think it's very important to remind everyone that pancreatic cancer especially locally advanced pancreatic cancer has been known in clinical research as one of the biggest graveyards.
Speaker Change: I mean all the trials so far mainly face two trials have failed so here we're presenting [inaudible]
and we will present the first phase three that is...
Speaker Change: and positive and chose in the political packaging you'll see that are real benefit to the patient now.
Speaker Change: When we look at the big picture, of course, it's also about the metastatic...
The status of that disease and death.
Speaker Change: Thank you for reminding us that an over four does combine a checkpoint inhibitor in metastatic disease and we do have some indications
We have some impact outside of the tree.
Speaker Change: I'm looking, you know, in a very positive way towards those results for next year and I'm thrilled with the community [inaudible]
Thank you
Our next question comes from Jason Bednar, with Piper Sandler
Speaker Change: Good morning. Thanks for taking the questions and all the extra color today on also one cancer and graphs on the recent developments. Why don't I focus maybe with the early experience in that one cancer indication and following on Larry's question, maybe asking in a bit of a different way?
Speaker Change: I hear you on the med tech like Ramp being fairly linear, but with that in mind, you have a total target prescriber base you're going after what are doctors waiting to see before having greater confidence also in writing prescriptions versus the roughly one per cord we saw here in the first quarter.
Thank you for watching!
Speaker Change: Hi Jason, this is Frank. Thank you for the question and what I what to say is that, you know, we [inaudible]
Speaker Change: We keep going back to our message of right position, right patient and right time. And,
Speaker Change: That is important for us because we do believe in introducing a new device-based treatment to the medical oncology profession that the first experience is really critical.
Speaker Change: And along those lines, I think the number that I'd highlight in what we released today is to look at the fact that the stage for the line of therapy right now has been second and third line.
Speaker Change: Majority and that's really what we've been focused on so that we were getting those right patients where we're going to have enough time to deliver quality therapy to them.
and then ensure that that position is then, you know...
Interested and motivated to put the next patient on therapy
Speaker Change: So that's a bit of a way of saying that, you know, looking at the targeted prescribers list, you know, we, you know, we do obviously have a targeted prescribers list We do have sort of a set, you know, number that we're targeting overall
Speaker Change: But the sort of the pace in which that will play out is really going to be in a way that we do know that we're not going to go wide and have sort of physicians who have maybe put people on for salvage therapy, don't really know us, don't understand the therapy.
Speaker Change: That's not something that we'll do this year. We're really going to be very much focused on, do we have the right patients? Did we deliver the right first experience? Along with that, did we drive growth? Are we driving up the number of prescribers? [inaudible]
Speaker Change: So you did see that in the sense that we moved from, you know, we didn't give the number last quarter but we have moved up to 60% or now new prescribers to tumor treating fields and I think that number will continue to increase as we move forward.
Ingrid Goldberg, William Doyle, Ashley Cordova
Okay.
Speaker Change: Thanks Frank. Maybe you'll, one follow up to there and then a separate question.
I mean, as we could please think out. Thank you very much.
Speaker Change: A year or two from now, does the growth and long come more from growing the prescriber base, or getting the current prescribers that you have, going deeper with those prescribers, you're trying to understand the different livers there, and then separately, what's this status with getting long added to NCCN guidelines, and how important is that to the commercial efforts?
Speaker Change: Cal Poly San Luis Obispo Cal Poly San Luis Obispo Cal Poly San Luis Obispo
Speaker Change: Yeah, absolutely. So on the first question, you know, it will be a mix of both that we do want to...
Speaker Change: Get, you know, call it better depths inside practices that we are, you know, routinely being prescribed [inaudible]
Speaker Change: We will also need to grow the prescriber base. Medical oncology as a profession is significantly larger than the group we deal with for neuro oncology. So there's going to have to be growth.
Speaker Change: But what I will say to highlight on the death issue, you know
Speaker Change: And then on the NCCN, NCCN guidelines are absolutely the gold standard in terms of determining clinical practice for a non-smalthal lung cancer.
Speaker Change: We are very focused on making sure we've provided the community with enough education that tumor treating fields will be reviewed at the upcoming July meeting for the NCCN.
Very helpful. Thank you
Thank you for watching!
Speaker Change: As a reminder, if you'd like to ask a question at this time, please press star 11 on your
Our next question comes from Vijay Kumar with Evercore ISI
Thank you for watching!
Hey guys, thanks for taking my question.
Speaker Change: Actually, maybe on the first one high level, the long prescriptions with a metastatic setting. Looks like it went up 40 since the last update we gave. How is that 40 prescriptions per quarter?
Speaker Change: at this stage of the launch phase. Is that a positive number? What is the right context to think about the prescription ramp?
Speaker Change: Yeah, I'll just read yes is the short answer so 92 prescriptions in the quarter which is very much in line with our expectations and I'll just reiterate some of the points that Frank has brought up that we are focused on the right position, the right patient at the right time [inaudible] and the right patient at the right time and the right patient at the right time
Speaker Change: to productively engage with this therapy and you know at the right time so that we're able to get paid for it as we build up the reimbursement support. So yes, is the short answer we are we are pleased with the traction we've seen. Thank you.
Speaker Change: So far, and again, we'll look forward to providing further updates, but everything that we see out in field so far points to the fact that there is an unmet need here that physicians are willing to engage in a new therapy to fill that unmet need and that they're excited about the potential to extend survival with optimal.
Speaker Change: And then on the same mark in Germany, what's the reimbursement paper in that Germany? Is this on a case-by-case basis or do you have rather reimbursement and how would revenue recognition work in that Germany?
Speaker Change: In Germany, we will be following a similar path in the US. It is, you know, more attuned to the commercial side of the US market than it is the Medicare side of the US market, but we think we'll be able to get to successful resolution of those appeals in a more standard predictable reimbursement rate over the course of the year. [inaudible]
Thank you for watching!
Speaker Change: And Christoph, maybe a couple of marling questions for you.
Francis Ridley-Schron, I thought Francis-
Speaker Change: May be comments suggested, perhaps, where Peaches stage in France, may we talk about France opportunity and overall when you look at the revenue picture in the quarter, any, any one offs, any, any CMS back there, etc. That we should back out.
Speaker Change: Yeah, so first I point to, you know, I mean, we had 12% revenue growth in the quarter and we had active patient growth of 11% when you look at, you know, what really drives revenue. It's, um, opportunity, or that where we had 9% revenue growth. So, you know,
Basically that gives you what we're growth from from price [inaudible]
Now...
Hi. It's been a great conversation. Lots of fun.
Speaker Change: France was very strong, but also when you look at the quarterly revenue projection or revenue evolution of prior year Q1 was the lowest quartering in prior year and that we had very significant growth in Q2 so we would expect the growth in France to slow down as we progress through the year.
Speaker Change: And from a big picture perspective, what we said in our last call is that for this year we expect growth in the low to mid-single digit range and that's still what we were to expect for the
Speaker Change: Anderson, and then maybe one last one for you on with the updated tariff picture. Are we looking at gross margins of low-seminis or are we looking at the mid-seminis gross margins?
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Speaker Change: Yeah, so as a reminder, what we said in our last call is that for 2025 we were looking at gross margins in the low 70s for 2025.
Speaker Change: At the time, there were two headwinds. One is the launch in Lung, where we treat unlabeled patients before having reimbursement. So essentially, we have the cost before we have the revenue.
Speaker Change: And then the other headwind is the roller of the HFE array, which is more costly than the old one at this point in the life cycle of the array. Now, there's a third headwind that came to it, which is now the terrorist.
Speaker Change: And a big picture how we think about it is that our gross margin assumption for this year has not changed [inaudible]
Speaker Change: We are actually ahead of plan with our cost reduction journey on the HFE race so that we believe we can also add a large impact from the terrorists with
Speaker Change: being ahead of cost reductions on the edge of ERA. So, gross margin picture for the year hasn't changed to what we've had before.
That's helpful. Thank you guys Thank you.
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Our next question comes from Jessica Fye with J.P. Morgan . .
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Jessica Fye: Hey guys, good morning. Thanks for taking my questions. I have a few. I'll just ask kind of a friend.
Jessica Fye: It's like a math question. Can you walk through why you would still owe an increase of 8 million in tariff if the pause extends through your end, but it only goes up to 11 million if it ends after 90 days?
Jessica Fye: 2nd, I know it's early, I'm curious if you're getting any early read in long around how long patients are staying on TTF therapy and if you think that'll track some early to waste on the lunar trial
Jessica Fye: And then lastly, can you just touch on how enrollment is going in a letter two and letter four and when we may expect enrollment completion there? Thank you.
Yeah, maybe to the first one on terrors. Um, um,
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Speaker Change: Look, I think what we also said in the call is the-
Jessica Fye: Primary impact on the array side is from importing a race from Israel to the U.S
Jessica Fye: The tariff during the pause is 10%, after that would be 7%, so it's a step up but it's not a huge step up and that basically explains why there is some difference but not a huge difference.
Thank you for watching. Bye.
Speaker Change: Hi, and with respect to the treatment duration for patients in the U.S. on the non-small cell lung cancer launch, I would just say first that if you think about the time that we've had since launch it's still very short and the first cohort of patients is just sort of crossing into that time period where we would be able to measure. But I can say that so far it's in line with our expectations from the lunar.
Speaker Change: Yeah, and just on Lunar 2 and Lunar 4, we're still in the kind of site activation and kind of early enrollment phase of those. So I would say once we have clear line of sight to patients per site per month across our footprint, we'll provide the updated guidance there. But at the moment, I would say early days on track, but not yet. So I would say early days on track, but not yet. I would say early days on track, but not yet.
Far enough along an enrollment to indicate timing
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Our next question comes from Emily Bodnar with HC Wainwright
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Emily Bodner: Hi, good morning. Thanks for tuning the questions. I got to a first one for Germany with the long-alonged.
Emily Bodner: If you can kind of discuss how you think about ramp up their relative to your current ramp up in the US and also in terms of the initial 1.5 million that was recognized I believe.
Emily Bodner: 0.7 million, which were long. How should we think about revenues in the U.S. for 2025 since it seems like you're able to get the reimbursement already? Thanks.
Speaker Change: Hi, I'll start with addressing the the launch in Germany, and I'll just start by saying first that we are very pleased with the label that we've secured under the theme arc. We, you know, once again we have access to this. [inaudible]
Speaker Change: Broad Population of Patients who have had a platinum failure in the first line and
Speaker Change: Just as in the United States, these patients in Germany have a high unmet need that we can can address with high clinical value so we're starting from the fact that we think we have a big population and and a good label. [inaudible]
Speaker Change: We also have a strong team in Germany that has been able to promote to the NPM indication and I think as you look at the numbers they're relatively small but you can see that there was a focus on NPM in the fourth quarter and the first quarter [inaudible]
Speaker Change: So the team is in the field, knows the doctors, ready to go and I think you know what I can say is we're not going to provide a sort of specific direction of
Speaker Change: targets for the year of the quarter, but I can't say.
Ashley Cordova: What Ashley said, which is Germany generally mirrors our US business in terms of how medicine is practice, how the reimbursement system works and so our launch strategy will you know will be largely the same [inaudible]
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Yeah, and on the other question, [inaudible]
Ashley Cordova: Revenue for NSLC, I mean, 0.1th, it's going to be...
Ashley Cordova: Reflective of the cash collections in the period, right? And then, quarter of a quarter, it will reflect the ram on the patient side.
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Ashley Cordova: But it is a good sign that we've seen revenue come in the draw. I think already I think what we're seeing is we're able to get these bills off the door, we're able to get insurance approvals and actually we're able to get fully through that cash collection cycle within, you know, a quarter, which is, which is certainly promising. Thank you very much.
Thank you for watching!
All right, thank you.
Ashley Cordova: That concludes today's question and answer session. I'd like to turn the call back to Bill Doyle for closing remarks.
Thank you. Thank you. Thank you.
Bill Doyle: So once again, I'd like to thank everyone on the call for their interest in Novocure for their interest in Novocure Ltd.
Ashley Cordova: I'm very pleased that after a very strong 2024, we've been able to continue that momentum into Q1 and achieve some very important milestones so far.
Ashley Cordova: We're delighted with the CE mark for non-small cell lung cancer in Europe . We're looking forward to progress in Japan and adding that market to our trio of non-small cell lung cancer markets.
Ashley Cordova: We couldn't be more pleased with our positioning at ASCO for the presentation of the Panova data set.
Ashley Cordova: As has been mentioned several times, the so far the only phase three trial to be successful in the locally advanced pancreatic cancer population.
Ashley Cordova: and then on the regulatory front, we're pleased with the progress that we've made with both medicine, Panova and we anticipate the completion of those filings and the being potentially launch ready in 2026.
Ashley Cordova: So it is exciting at Novocure. We're well into the pivot that we've described as we take the company from our solid base in GBM into the next
Ashley Cordova: Chapter, where we're an international multi-indication oncology company. And again, thank you for your continued interest in Novocure.
Thank you for watching!
Thank you for watching!
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.