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spk14: Good day and thank you for standing by. Welcome to the NOVA Cure Q1 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg.
spk06: Good morning and thank you for joining us to review NOVA Cure's first quarter 2024 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, .nvk.com and on our investor relations page under quarterly report. 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, and are 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 evaluate our business, specifically adjusted EBITDA, a measure of earnings for interest, taxes, depreciation, amortization, and share-based compensation. 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. Reconciliation of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 8K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. 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.
spk03: Thank you, Ingrid, and good morning. At Novocure, our mission is to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy, tumor-treating fields. Over the last two decades, we've established TT Fields' mechanism of action, developed and improved the TT Fields' delivery technology, completed multiple successful phase three clinical trials, treated over 30,000 commercial patients, and built an innovative business model. We entered 2024 ready to build on this foundation, and I'm pleased to report our progress today. In March, we announced that our MEDIS phase three clinical trial, studying the benefits of treating brain metastases from non-small cell lung cancer with TT Fields' therapy met its primary endpoint, providing a statistically significant extension in time to intracranial progression. Later this year, we expect FDA, PMA, and EU CE-MARC approvals for TT Fields' therapy in metastatic non-small cell lung cancer post-platinum progression, and an FDA PMA supplement approval for our next generation arrays for GBM. Toward the end of 2024, we will announce top line data from our phase three trial in locally advanced pancreatic cancer. 2024 is an exciting year for Novitur with many milestones. I am incredibly grateful for the hard work of our colleagues and for the dedication of our patients and prescribing physicians.
spk24: On today's
spk03: call, we will begin with a review of our commercial business in GBM. We will then discuss clinical trial updates from the quarter, and we will close with a discussion of our Q1 financial results before opening the line for questions. In the first quarter at Novitur, we continued our steady pace of execution. We finished Q1 with 1,643 new prescriptions and 3,845 active patients on therapy. Both are global records for our organization. Our global commercial team is focused on all levers of active patient growth, including prescriptions, patient starts, and long-term compliance and persistence. We believe each input is critical to achieving the best outcomes for patients, which in turn we believe will drive sustainable growth. We also believe product
spk02: development enhancements
spk03: can drive improved patient outcomes. As a reminder, last year we successfully introduced our next generation arrays in several European countries, and our PMA supplement for the new arrays was filed with the FDA in December. The new arrays are lighter, thinner, more flexible, and leverage new materials to improve the patient experience. New patents have been filed in our key markets to protect the improved designs. In the U.S., our teams are focused on increasing awareness of the benefits of TT Field Therapy among potential patients and prescribing physicians. Last month, we launched a -to-consumer campaign, I Power My Life. Our new print and digital assets and our first-ever -to-consumer television advertising campaign are key to our efforts to grow our GBM business. Through connected television, which reaches most U.S. households, we are educating potential patients and caregivers about Optune Geo. We believe -to-patient messaging will raise awareness of TT Field Therapy and strengthen the demand from patients following diagnosis.
spk24: As we look ahead,
spk03: one of our key objectives in 2024 is to successfully gain approval and launch Optune Lua for patients with non-small cell lung cancer. We have filed regulatory submissions in our major markets. In January, the FDA formally accepted our PMA for filing. We recently completed our 100-day meeting with the FDA, a critical milestone for any PMA submission. The 100-day meeting was productive, and there was no indication that the lunar PMA will be referred to a panel. Outside the U.S., we are awaiting a CE mark decision in Europe and are in substantive discussions with Japanese regulators. Pending regulatory approvals, our teams are focused on launch preparation. In both the U.S. and Germany, we have hired and trained our thoracic sales teams, including territory managers, clinical educators, and patient experience teams. Within the organization, we are preparing for the opportunities ahead. Our teams are developing marketing materials and field team training assets, preparing HCP certification resources, assembling materials for future thoracic speakers bureaus, planning for thoracic congresses, and training internal support teams. We are prepared to hit the ground running. We plan to treat patients in Germany and the U.S. immediately following approval using a named patient reimbursement process, similar to the way we launch treatment for GBM in these countries. Our teams are eager to support another large indication and hope to treat many more patients in the coming months. I will now pass the phone to Assaf to share more regarding our clinical pipeline update.
spk18: Thank you, Bill. In Q1, we made strong progress advancing our clinical pipeline in three main indications. I will start with METIS. In March, we announced our Phase III METIS trial, METIS primary endpoint, marking our latest positive Phase III clinical trial. As a reminder, METIS studied TT-FILS therapy with supportive care for the treatment of brain metastasis from non-small cell lung cancer, following serotactic radiotherapy. Patients in the TT-FILS therapy arm achieved a .9-month median time to intercranial progression compared to 11.3 months in the control arm. The results were statistically significant, with a P-value of 0.016. The Alvar ratio was 0.67. Patients treated with TT-FILS therapy experienced sustained neurocognitive function and quality of life without an increase in systemic toxicity. The METIS results are very meaningful to physicians, patients, and caregivers. Many thousands of non-small cell lung cancer patients suffer from brain metastasis each year. Their prognosis is poor and typically involves rapid neurocognitive decline with devastating effects on quality of life factors, such as motor skills, speech, mood, and cognitive ability. Today, there is limited innovation or studies in brain metastasis. The only treatment options are serotactic radiosurgery, which has risk of continuous relapse, and whole-brain radiotherapy, which risks major neurocognitive toxicity. For this patient population, TT-FILS' ability to significantly extend the time to internal progression, delay the need for repeat SRS, and sustain neurocognitive function without increasing systemic adverse events offers major benefit. Key opinion leaders have validated our enthusiasm for the METIS results. Last week, we were pleased to announce that the METIS trial has been accepted as a late-breaking session at the 2024 ASCO annual meeting, and will be presented in Chicago on Monday, the 3rd of June. The METIS presentation was submitted and accepted by ASCO long after the standard Congress deadlines, validating our belief in the clinical relevance and interest in the study. I would like to express my thanks to the investigators and patients involved in METIS, as well as our NovoQ team, who supported the planning and execution of the trial. This quarter, we also announced that our InnoVate 3 Phase 3 clinical trial results were selected as the best oral presentation at ASCO 2024. InnoVate 3 studied TT-FILS therapy together with pachytaxel in platinum-resistant ovarian cancer, results from an exploratory subgroup analysis that showed pegulated liposomal doxorubicin, or PLD, naïve patients treated with TT-FIL therapy and pachytaxel. So, a significant improvement in overall survival compared to PLD naïve patients treated with pachytaxel alone. Of the 558 total patients involved in the InnoVate 3 clinical trial, 201 patients were PLD naïve. Overall survival in PLD naïve patients randomized to receive TT-FILS therapy and pachytaxel was 16 months compared to 11.7 months in PLD naïve patients randomized to receive pachytaxel alone. In the PLD naïve subgroup, baseline demographics were similar across both cohorts. This analysis may help to explain the potential survival benefit previously reported in InnoVate 3 patients who received only one prior line of therapy. Novacur is exploring the effects of doxorubicin on tumor tissues and the potential consequences on TT-FILS dose. We believe these findings will contribute to a deeper understanding of our mechanism of action and inform future trial designs. Finally, within our GBM program, we completed enrollment of the Trident trial studying overall survival when Optune-Geo is started with chemo radiation compared to starting after chemo radiation. And the FDA approved our IMD for keynote D58, a phase 3 clinical trial studying overall survival of newly diagnosed GBM patients treated with TT-FILS, temozolomide and pembolizumab. The keynote D58 trial builds upon promising clinical data from the to the top phase 2 trial and extensive preclinical research published in JCI. We accomplished a lot this quarter. I would like to reiterate my gratitude to the team. I look forward to our future report on our milestone field 2024. Ashley will now share details of our first quarter financial performance.
spk08: Thank you, Asaf. The first quarter was a period of consistent execution with commercial and regulatory progress, launch preparation and important clinical readout. We generated $139 million in net revenues in the first quarter, up 13% year over year and ended the quarter with 3,845 active patients on therapy. Up 11% year over year. Revenue growth was primarily driven by our successful launch in France and improved approval rates in the US for both current and 2023 periods. Growth margin for the first quarter was 76%. SG&A expenses were $95 million this quarter, up 2% year over year. The modest increase in sales and marketing expenses was driven by sales force expansion and increased marketing activities in anticipation of a potential launch in non-small cell lung cancer. These investments were partially offset by lower personnel expenses within G&A. R&D expenses for the quarter were $52 million, down 14% year over year. The decrease was driven primarily by lower personnel expenses and the timing of activities within our ongoing clinical trial portfolio. Our net loss for the first quarter was $39 million, or 36 cents per share, and adjusted EBITDA was a negative 5 million, an increase of $14 million compared to the first quarter of last year. The increase in adjusted EBITDA was primarily driven by revenue growth, and an associated increase in growth margin. Actions taken during the November 2023 restructuring and a heightened focus on driving operational efficiencies reduced total operating expenses, excluding share-based compensation, by $2 million year over year. We intend to take actions that prioritize growth and maintain financial health and flexibility as we position Novicure for future profitability. Cash and short-term investments totaled $870 million as of March 31, 2024. This morning, we announced that we have entered into a new five-year senior secured credit facility with affiliates of Pharmacon advisors for up to $400 million. The first $100 million tranche was issued at closing, and the second $100 million tranche will be issued by June 30, 2025. An additional $200 million is available to be drawn across two tranches at Novicure's discretion and subject to certain milestones through March, 2026. The proceeds will be used to settle upon maturity Novicure's convertible notes, and to fund working capital needs stemming from Novicure's anticipated launch in Loan Settlement Yard. The full terms of the deal are outlined in today's 10-Q. Importantly, with this transaction, we have strengthened our cash position and further solidified our balance sheet with non-dilutive capital. With a number of exciting milestones on the horizon, this multi-tranche delayed draw debt facility provides us with valuable balance sheet flexibility. At Novicure, we appreciate the importance of balancing both growth and profitability, and we have a watchful eye on achieving both objectives. I'd like to close today by highlighting one of our Optune Geo users, Kelvin Doc Sinclair of Sacramento, California. Doc is a man of many passions. He composes music, collects minerals, raises koi, and operates a bodybuilding gym from his home. Most of all, he enjoys spending time with his wife, Tara, and his three children and seven grandchildren. In February 2022, Doc was diagnosed with glioblastoma, and after discussions with physicians and considerable research, Doc decided Optune Geo was right for him. Optune Geo has helped Doc continue an active lifestyle without having to sacrifice his numerous hobbies. It's people like Doc who remind us why we do what we do and what it means to extend patient survival in aggressive cancers like glioblastoma. We have an exciting slate of potential catalysts approaching. The MEDIS data presentation at ASCO, upcoming regulatory decisions for the Lunar CE Mark in Europe and the PMA submission in the US, the PMA supplement for new arrays, and finally, top-line data from our Phase III Panova III trial in pancreatic cancer. Our teams are heads down and focused on execution, and we look forward to updating you throughout the year. With that, I'll hand it back to the operator for questions.
spk14: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for our first question. And our first question comes from Jason Bednar of Piper Sandler. Your line is open.
spk04: Hey, good morning. Congrats on the results here today, team. I wanted to first start on non-small cell. Good to hear that you don't think you'll face an advisory committee panel, that is a good sign. Are there any other items you can share from your 100-day meeting with the FDA, any feedback or early indication the FDA is giving you on this mission? And then, kind of related, I know you've been hoping to get CE Mark here ahead of PMA approval. So just similar to my question on the FDA interactions, anything you can discuss with respect to your conversation with the regulatory body in Europe?
spk20: So good morning, and thank you for questioning the staff. So the 100-day meeting was a very productive meeting. And we review mainly the labeling and making the decision to put it in the right place. And we'll be expecting to continue interaction with the FDA. And as you mentioned, we believe that we will not have a panel meeting. Regarding the European, we continue our discussion with the regulator, and we basically, it's ongoing discussion, which we're expecting by the first half of this year to get the CE.
spk04: Okay, so no change in the CE Mark timeline. That's still here within the next couple of months. That's good. The launch in France clearly going very well. Seems to be driving a lot of upside here. Script and activation growth is accelerating. That should be another good leading indicator of what's possible as you look to some other international markets. I didn't hear any other updates today, but will we see a commercial launch this year? Kind of where do you stand with your plans for some of the other major European markets where you don't currently have a presence?
spk17: Jason, thank you for the question. This is Frank. Yeah, we're very first, I just would reiterate that we are very pleased with the progress we've made in France and how we opened the market and conducted the launch. And as you can see in the numbers, we're seeing France size up to be around a Germany-sized opportunity in terms of revenue. We continue to work on additional markets. We kind of will give updates on those markets as they become more, we have line of sight on specific milestones that we can pass along. So no direct updates right now, but we do continue to look for those additional opportunities.
spk04: All right, maybe one quick follow-up there and then one other housekeeping one for Ashley. Just Frank, I guess any timelines you're willing to share or markets that you're prioritizing, again, just trying to get a sense of this is something that's maybe coming later this year, next year, and again, which markets to think about. And then Ashley, apologies, it's a busy morning here with a lot of reports. I haven't really had a chance to go through the full debt terms, but can you help us with the rate you're paying on the debt? And then I wanna confirm that you're planning to settle the convert fully in cash when it comes due next year, is that the plan?
spk17: So Jason, this is Frank again. I'll answer on the markets question first. So again, we're not going to provide specific timelines today, but I think in terms of markets, we've said before, we're looking at the big markets in Europe. So obviously working multiple different areas, but Italy and Spain are both in that mix, and as we get closer to real milestones, we'll pass those along.
spk08: And Jason, I'll just do cleanup on your housekeeping. So thanks for the question there. I'll remind everybody, we did announce this morning that we have signed a new five-year senior secured credit facility with Pharmacon. These are partners we know well. It is a $400 million facility, 200 of which we are committed to draw, 100 of which we drew this morning, and 100 of which we will draw June next year, and 200 of which we have to draw at our discretion. The terms are SOFR plus six and a quarter, so it is a floating rate facility there, and our anticipation is that full use of proceeds will be to settle the convertible notes when they become due in November 2025 and fund our working capital needs and non-summit on cancel. We believe this is sufficient to fully remove any cash overhang related to the settlement of those convertible notes, so we're now kind of eyes ahead looking at a balance sheet that will carry us through our strategic plan.
spk05: Perfect, thanks so much, congrats again.
spk14: Thank you, one moment for our next question.
spk11: And our next question comes
spk14: from Jonathan Chang of Lee-Ring Partners, your line is open.
spk21: Hi guys, good morning, and thanks for taking my questions. Two questions, first on the meta study, congrats on getting a late breaker at ABBA, ASCO, can you help set expectations ahead of that ASCO presentation?
spk23: So Jonathan, good morning, this is Nicholas, and thank you for your question. As you know, meta is a phase three trial in brain metastasis, non-small cell-line cancer, and it comes with a huge amount of data, so we will show the top line results, the initial analysis because we're still working on it, and for the rest, I would kindly invite you to come and see us in five weeks.
spk21: Got it, maybe also second question on the meta study, on the secondary endpoints, well I appreciate you're limited in what you can say today, are we able to at least help us rule out the possibility that
spk13: any
spk21: of the endpoints are trending in the wrong
spk13: direction?
spk23: So I think, again, direct you to ASCO, but so far we are really excited to show and demonstrate the superiority of TGPL in that area.
spk13: Understood, thanks for taking the questions.
spk14: Thank you, one moment
spk11: for our next question. And our next
spk14: question comes from Jessica Phi of JPMorgan Chase, your line is open.
spk10: Good morning, guys, this is Nassan on for Jessica Phi. Question on the, when you look at the meta study and consider the commercial opportunity for brainmets, like given what you've seen from the study, where's your current expectation for the sort of peak commercial opportunity in that indication? And then second, I think it's very interesting that you guys have decided to go ahead with another pancreatic indication. Is it driven by what you are seeing in the phase three panavis study that you have decided to start another study in the pancreatic indication? That's it for me, thank you.
spk08: So now this is actually, maybe I'll start with a market sizing update with the data from RK and then I'll pass it over to Frank to provide some additional clarity on the commercial opportunity meta. I do for the avoidance of Delta within pancreatic and I just want to say that we have always had the PNBA-4 trial ongoing, so that is part of our ongoing pipeline and one we're very excited about and committed to as a part of our long-term strategy, but there's no update there, that's just a successful open and enrolling trial. With regards to the market size for MEDIS, this is a very significant opportunity, 25% of patients have a brainmets diagnosis, a brainmets at diagnosis of non-small cell lung cancer and approximately 50% of non-small cell lung cancer patients will develop brainmets at some point over the course of their disease journey. So it is a very large population, but admittedly it is also a very heterogeneous patient population and a patient population who is having to focus on both treatment of the primary tumor and systemic therapies at the same time as managing the METs. So we are recommending that you take a conservative estimate, there's not a lot of precedent for systemic therapy treatment in brainmets, as we noted there are few companies that go in this space, so we recommend you're conservative and in the K we are recommending that you model 16,000 patients annually in the US as an opportunity set. We'll start there and then I think we'll be able to explore how that can grow, but that's what we're anchoring to for your expectations.
spk17: Yes, and this is Frank, I'll add some color just in terms of what we're hearing from our customers. In reaction to the data, it's been a very strong reaction, it's positive and sentiment and I think, highlight that it was accepted as a late breaker at ASCO.
spk15: So we've seen the
spk17: PIs who are a part of the study as well as some of our customers who treat glioblastoma reach out with engaged interest here and see this as an area of high on MET needs.
spk11: Thank you, one moment for our next question.
spk14: And our next question comes from Vijay Kumar of EfferCorp ISI, your line is open.
spk22: Hi, this is Kevin on floor, Vijay, thanks for taking our question. Just a follow up question on your meeting with the FDA. Does the FDA specifically indicate the need for an ad comp panel at these meetings and is there an opportunity for the FDA to come back and ask for an ad comp?
spk19: Thank you for a question. So, you know, the FDA can do
spk20: many things, but in principle, when there is a panel, we were in the stage that we were supposed to know about it and during the meeting, the panel was not mentioned as an option, so, you know, we still believe that we will not have a panel.
spk22: Got it, and on panel number three, the timeline looks like the data is now expected in the second half of this year, what changed versus the prior expectation of fourth quarter?
spk03: Yeah, so nothing's changed. So we're in the stage, we announced when the trial, this is Bill, by the way, we announced when the last patient was in, this is a trial that's designed to read out 18 months. Following the last patient in, we're still on track to read out after the data are cleaned. So there's been no change in the expectations for Panova.
spk11: Thank you.
spk14: Thank you, one moment for
spk11: our next question. And our next
spk14: question comes from Emily Bodnar of HCWayneRite. Your line is open.
spk09: Hi, good morning. Thanks for taking the questions and congrats on the progress. I'm curious if you could provide any timing for potential PMA submission based on your MEDIS study, and then separately, any potential new indications that you're kind of looking to advance into later stage studies now that your major phase three studies are kind of coming to an end? Thank you.
spk07: Emily, I think, transparently, it's too soon on both of those points.
spk08: So the MEDIS data is very fresh. We're doing the analysis now, looking at a range of options given our current indication footprint and where we would like to go with that disease. So it's simply too soon to comment on timing. We will update you all as we have more news. And I would actually offer that same message on our pipeline. We are committed to executing the pipeline commitments that we shared last year, and that strategic prioritization that we shared in November. So that is clearly advancing the GBM, opportunities to extend survival in GBM with our trial and our keynote D58 trial that is continuing to invest in lung. And it is also focusing on pancreatic cancer. We know we won't be done there. This is a platform therapy we believe that has significant broad applicability, but that's what we're focused on today. And we'll come back with further updates as we happen.
spk14: That makes sense, thanks. Thank you. We have no further questions this time. I'd like to turn it back to Bill Doyle for closing remarks.
spk03: So thank you everyone for joining this morning and your continued interest in Novicur. Q1 was a quarter of real executional progress. We're very pleased with the milestones achieved, including of course, Metis hitting its primary endpoint and our acceptance as a late breaker to present the first analysis at ASCO. We're very pleased as Asaf described with our 100 day meeting at the FDA and where we stand in the regulatory process, both in the US and Europe. TRIDEN is a very important study for us. And we're pleased that enrollment is complete and we're now in the timing period to releasing those data. As always, working with the FDA, when we achieve a milestone like the IND approval for D58, that's a very important milestone in terms of getting that exciting trial that of course is based on the to the top data with immune checkpoint inhibitors up and off the ground. And then finally, the financing. We know that we've received a bunch of questions about how we were going to retire the convertible debt that we have on the balance sheet on very good terms, I'll underline. But we think with the financing announced this morning, we will have answered those questions and made it very clear how we intend to proceed in our path to profitability. Big thanks, Arode. Thanks to everyone on our team. Thanks to our patients and prescribers. And there's a lot more to come in 2024. We look forward to updating you on all the progress in future calls. Have a good day.
spk14: This concludes today's conference call. Thank you for participating and you may now disconnect. Yeah.
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