Good day, and thank you for standing by. Welcome to the NovoCure's Q1 2023 Earnings Conference Call. [Operator Instructions] 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. Please go ahead..

Good morning, everyone. Thank you for joining us to review NovoCure's First Quarter 2023 Performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A.

For your reference, slides accompanying the earnings release can be found on our website, www.novocure.com, on the Investor Relations page under Quarterly Reports.

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 statements, 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.

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.

Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides and in our Form 8-K 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..

Thank you, Ingrid, and good morning. At NovoCure, our mission is to extend the lives of patients diagnosed with aggressive forms of cancer.

Over the last two decades, we've completed multiple successful clinical trials, expanded our international footprint to include 10 global markets, published over 500 manuscripts, built a strong and sustainable business model, and most importantly treated over 27,000 commercial patients.

We are proud of the business we have built and people we have helped. Next month at the American Society of Clinical Oncology Annual Meeting in Chicago, we will present the results of our Phase 3 pivotal LUNAR trial in non-small cell lung cancer.

Our ASCO presentation will mark the beginning of NovoCure's next chapter, with the intention to help tens of thousands of additional patients diagnosed with deadly cancers in the coming years. I am grateful for the hard work of NovoCure's employees, as well as for the dedication and courage our patients and prescribing physicians.

I cannot wait for all that lies ahead in 2023. On today's call, we will begin with a discussion of our clinical catalysts, followed by a review of our core business in GBM. We will close today's call with a discussion of our first quarter financial results before opening the line for questions.

Earlier this year, we announced the top line results of the Phase 3 pivotal LUNAR clinical trial evaluating TTFields together with standard of care therapies in Stage 4 non-small cell lung cancer. LUNAR met its primary endpoint, providing the first advanced in Stage 4 refractory non-small cell lung cancer in more than 7 years.

LUNAR demonstrated a profound benefit when TTFields therapy was combined with immunotherapy meeting powered secondary endpoint, valuating overall survival of patients treated with TTFields and a checkpoint inhibitor versus a checkpoint inhibitor alone.

LUNAR also demonstrated the positive trend in overall survival for patients treated with TTFields and docetaxel versus docetaxel alone. We are pleased to share that the LUNAR data will be presented next month at the ASCO annual meeting in Chicago. On Tuesday, June 6, lead investigator Dr.

Ticiana Leal of Emory University will present the LUNAR trial findings during the metastatic non-small cell lung cancer session. Later on Tuesday, NovoCure will host a presentation and question-and-answer session with Dr. Leal; fellow LUNAR investigator Dr. Corey Langer at the University of Pennsylvania and [indiscernible] leadership.

I will remind you the improvements in overall survival demonstrated by LUNAR follow a period with no clinical improvement in the treatment of non-small cell lung cancer following platinum failure since 2016. LUNAR is the first of multiple Phase 3 pivotal trials set to read out over the 1.5 year, each focused on a population with high unmet need.

Later this year, we expect to announce top line results from the Phase 3 pivotal INNOVATE-3 trial in platinum resistant ovarian cancer. In early 2024, we anticipate the top line results from the Phase 3 pivotal METIS trial, evaluating the use of TTFields for the treatment of brain metastases from non-small cell lung cancer.

And following the completion of the 18-month follow-up of the last patient enrolled, we expect top line readout of the Phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer in 2024. These pivotal clinical trials will provide the foundation for the next stage of NovoCure's growth.

In the U.S alone, the number of diagnoses of the cancers treated in these trials is nearly 14x the annual diagnoses of glioblastoma, an indication in which we have a strong and sustainable commercial business. The outcomes of these pivotal trials could enable tens of thousands of patients to benefit from TTFields therapy.

That promise to extend the lives of patients diagnosed with aggressive forms of cancer, continues to drive us every day. With the potential to treat many thousands, more patients soon, we believe we are one step closer to achieving our mission.

I look forward to seeing many of you in Chicago next month and to updating you throughout this exciting time. With that, I will turn the call over to Asaf, to discuss our commercial business..

Thank you, Bill. Before turning to GBM, I would also like to share my excitement and commitment to what is coming in the next 2 years. With multiple pivotal studies set to read out, it is an amazing time to be at NovoCure. We have a lot of rewarding work ahead of us to bring our therapy to many new patients.

One of our key areas of focus this year is to return to active patient growth in GBM. NovoCure's commercial business continues to provide the financial strength to invest for the future. Our commercial foundation has never been more important with the possibility of multiple commercial launches on the horizon.

We are proud of the resilient business we have built, but we know there are many more GBM patients that could benefit from TTFields therapy. We are determined to increase penetration in our current markets, reach patients in new markets, and help patients remain on therapy longer through education and product innovation.

Increasing market penetration in our current markets, where we have captured approximately 40% market share is essential to the growth of our GBM business. In recent months, we restructured our commercial organization to better leverage resources, and improved our digital footprint to engage more health care providers and patients.

In the US, we received 1,051 prescriptions in Q1, the most we have ever received in a single quarter. While we recognize and appreciate that in health care, systemic change does not occur overnight, we are encouraged by the U.S results. So though, we are seeing steady recovery in Germany, in both new patient starts, and reimbursement approvals.

While these are early indicators, we believe they show progress that will contribute to greater penetration in the future. We are also dedicated to entering new markets, enabling many more GBM patients to access our therapy. Earlier this year, we received reimbursement for opportunity in France.

France is the second largest country in the EU, and entering France will present a key execution milestone in our effort to reach patients in new markets. We have received our first prescriptions in France and have begun treating patients.

France is our second new market opening in less than 4 months following the approval of Optune in Canada in November. Our market access teams are engaged with health care authorities in a number of additional potential markets, with the goal of reaching more GBM patients in it.

Finally, we continue to focus on improving our technology to better serve patients. Clinical research shows that small time on TTFields therapy leads to better outcomes. And we want to enable patients to wear Optune for as many hours per day as possible. To this end, one of our most important initiatives is the launch of a new generation of arrays.

Our new arrays are thinner, lighter and more flexible than those in current use. Following a successful pilot launch in Austria last year, we are now rolling out in Sweden, and we are very pleased with the results to date. Patients have reported a materially improved treatment experience, both during daily activity and during sleep.

The new arrays are proving to be much more comfortable and we are seeing high patient usage rates. Our next steps are to launch in Germany and submit a PMA supplement to the FDA for approval to market in the U.S. We expect to submit a PMA supplement in the second half of the year.

We remain committed to improving the TTFields experience for patients and expect to loan further product enhancements in the years ahead. Before I hand the call to Ashley, I would like to thank our colleagues for the hard work over the first 3 months of the year. This is an exciting time to be as part of NovoCure.

And I know you're we are all ready to continue driving to help as many patients as possible. I will now hand the call to Ashley to discuss our financial results..

Thank you, Asaf. We began the year with a quarter of solid execution and a focus on investing our time and resources strategically to spur growth in GBM to progress and expand clinical and product development programs and to a solid foundation for potential future launches across multiple indications.

In the first quarter, we generated $122 million in net revenue, and ended the quarter with 3,467 active patients on therapy. As expected, the impact of slowing collections from previously denied and age U.S claims caused a $5 million headwind in the quarter.

While active patients were down year-over-year, we are seeing promising green shoots from our restructured U.S CNS franchise. In Q1, we established a high watermark in quarterly prescriptions, and we remain focused on a return to growth in our GBM business.

In Germany, as expected, we saw a $2 million decrease in year-over-year net revenues following 2022 payer negotiations. We continue to see signs of recovery in Germany, as active patients grow and patient mix shifts towards approved coverage. Gross margin for the first quarter was 76%.

Margin was impacted by a planned increase in patient support capacity and preparation for potential future launches, as well as the ongoing launch of our new array. SG&A expenses for the quarter were $93 million. We have increased sales and marketing activities intended to increase awareness in Tumor Treating Fields as we enter new geographies.

We have also expanded our supply chain and increased spend on information technology enhancements to enable future growth. Research and development expenses for the first quarter totaled $60 million. In the past 3 months, we completed enrollment of both our PANOVA-3 and METIS Phase 3 pivotal trials.

As these and our other Phase 3 trials near completion, we expect to replenish our clinical pipeline with new trials across a variety of solid tumor cancer. In addition, we will continue to fund product development initiatives designed to enhance patient ease of use, and optimize our therapy.

Cash and short-term investments totaled $958 million as of March 31, 2023. Our net loss for the first quarter was $0.50 per share, or $53 million and adjusted EBITDA was a negative $18 million.

We are investing strategically in growth initiatives to expand our capacity to treat larger patient populations, enhance our commercial capabilities, and to increase awareness of tumor treating fields in anticipation of future approval. All of these investments are supported by the strong foundation provided by our stable commercial business in GBM.

The future is bright for NovoCure and we look forward to updating you on our progress throughout the year. I'd like to close today by highlighting one of our Optune users. Mike Hugo of Wellington, Florida. Mike is 38 years old and happens to be a medical device sales manager in the CNS industry. He was diagnosed with GBM about a year ago.

Mike and his wife Vanessa, a clinical researcher go into the literature to explore his treatment options. Together, they determined that Tumor Treating Fields therapy could extend Mike's life and needed to be an essential part of his treatment. Last summer, Mike started using Optune.

After Mike's diagnosis, he posted a video on Facebook asking country singer Tim McGraw to record a duet of the song My Little Girl with them. Mike's goal was to have the song played at the future weddings of his two daughters, Bridget and Brooke. It turned out McGraw had also been impacted by GBM.

His father, legendary baseball player Tug McGraw, he died of GBM in 2004. When Tim heard Mike's message, he arranged for the entire Hugo family to fly to Nashville and meet him at the Grand Ole Opry. There with the cameras rolling, Mike danced with his daughters and sang a duet with the country icon.

We are honored to be a part of Mike's journey, and those of thousands of patients like him. We will continue to work tirelessly to drive our innovative therapy forward with the goal of making a meaningful impact in the lives of many more patients and their families. With that, I will turn it back to the operator for questions..

Hi everyone. I think we're having a technological problem.

Operator, you there please?.

Yes. [Operator Instructions] And our first question is from Greg Fraser of Truist Securities..

Good morning, folks. Thanks for taking the questions. On the U.S. market for GBM, you had double-digit growth in prescriptions, while active patients decline. Can you talk a bit more about that strong prescription growth? Is the base of Optune prescribers in the U.S.

growing? And should investors expect the prescription growth in the first quarter to drive [indiscernible] growth in the near-term?.

Greg, thank you for the question. This is Frank Leonard speaking. Yes, we are -- first, I will say that we're very encouraged by seeing the Q1 prescription results in the U.S. where we hit this record high -- as Ashley noted in her remarks, prescriptions are the leading indicator.

They are a component of the overall metrics that we have to drive in order to ultimately pull through on revenue growth. But just looking at prescriptions and demand indicators, we do see -- we are encouraged by the first quarter results. We think it reflects, in part, activities in Q4 and Q1.

First, the investments and the upgrades that we've made to the U.S. commercial organization, where we focused on putting the right people in the right place in front of our customers with the right incentives and tools to pull through to prescription.

Second, we've seen the dynamic where the overall macro environment in oncology has come back to in-person events. So we had an incredibly strong presence at snow in the fourth quarter, which is our main conference with neuro-oncologists.

Same with Astra, our main engagement point with radiation oncologist and then again in the first quarter at AACR, where scientific team had an incredible presence. So overall, I think the message that we are sending is that we're encouraged by the first quarter results, we think they reflect actual changes.

We wouldn't -- I wouldn't go to the point of noting any specific mixes or dynamics other than to say that we think we've got the right team now that we can continue to make progress..

Great. That's very helpful. And then just a question on the LUNAR presentation.

Some of the questions are been unknown or early the PD-L1 stats, clearly, whether you have data on PD-L1 stats for a large percentage of the patients, whether there was an imbalance, do you expect that the presentation will address these questions such that there won't be ambiguity about the results for the IO groups following ASCO?.

Yes. Yes, so good morning. This is Bill. So we were very pleased to announce that we will have an oral presentation during the metastatic lung cancer session at ASCO. So first and foremost, we are looking forward to seeing everybody in June.

Following the presentation, we will also have an investor meeting that will include KOLs, investigators as well as NovoCure personnel. And we would expect to address all the issues with respect to balance and PD-L1 status at that time..

Great. Just one more quick one, and I'll jump back to the queue. The average time on therapy is a very important determinant of with TTFields. Should investors expect to see data on time on therapy at the ASCO presentation? Thanks very much..

For LUNAR? Yes, I would expect that the data set this is actually will include average time on therapy. And I'll remind everybody that until you get that data, we ask you to anchor to the PFS in the Phase 2 trial..

Great. Thank you..

Thank you. One moment for our first -- next question. And our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open..

Hi, there. Thanks for taking the questions. Maybe to follow-up on the first question. Do you kind of view first quarter sales in the U.S.

as kind of a base? And should we expect increases in sales from here on now for the rest of the year? And maybe can you expand a bit on what kind of clinical trials you plan to initiate this year, whether they'll be early stage or late stage? And are there any other indications where you think combining with immunotherapy can make sense besides lung cancer and GBM? Thanks..

Emily, this is Ashley. I'll start because Frank was able to give color on the prescriptions and the leading indicators.

When we look at revenue, which is ultimately what we need to deliver on the GBM business, I would say that consistent with expectations, we need everybody to anchor to the core map of active patients times net price per month time, the number of months in the period when you're modeling up revenue.

So that would be 3 months for the quarter or 12 months for the year. And so Q1 performance reflects that as we no longer had the tailwind from age claims, and it is not our expectation that those would continue at the pace that we've seen in prior years in 2023. So I do think Q1 reflects that core map and we would like you to anchor to that core map.

That's an important base. Now we do have puts and takes against this. We've talked about the green shoots for prescriptions in the U.S. I will also note that the recovery in Germany is progressing as expected. And so we expect to continue to see some benefit in the net price at a global level over time on that.

But it is important to anchor to that core map and that's what we would likely to do in your model..

So -- and I will take the -- this is Bill again. I will take the second part of your question with respect to clinical trials. So we are all here because we're pioneering a new modality that targets the electrical properties of cancer cells rather than their chemical properties. And there are just so many exciting aspects to the platform therapy here.

We can use our therapy with all other therapies. So we see either synergy or additivity with radiation, chemotherapies. And one of the most exciting advancements has been what we are seeing now when we combine Tumor Treating Fields with IOs.

We see that in, for instance, the two of the TOP trial in GBM, where we've combined Tumor Treating Fields with pembrolizumab in a cold "cold tumor", and we see great results.

And of course, what we've alluded to and what we'll present at ASCO when we've combined Tumor Treating Fields with IOs in non-small cell lung cancer, a cancer where IOs are used routinely and we see a profound improvement. We know we can deliver Tumor Treating Fields to the head, neck, torso and abdomen.

And all of the -- these difficult cancers in those regions are our targets. And so the answer is yes. You should expect to see additional trials in the indications in which we're already working.

So for instance, non-small cell lung cancer, I would say we've just begun, and you'll expect to see additional trials there as well as trials in areas like gastric and hepatocellular carcinoma, where we've disclosed very promising Phase 2 data..

Great. Thank you..

Thank you. One moment for our next question. Our next question comes from Jessica Fye of JPMorgan. Your line is open..

Good morning, guys. This is Na Sun on for Jessica Fye. A couple from me. So when PANOVA-3 was completed enrollment, there was a mention of an interim look.

Can you say if that interim has happened yet? And what, if anything, the outcome was? And then in terms of INNOVATE-3, are we still on track to anticipate a top line data announcement in mid 2023? And then a full data presentation later in the back half of the year? And then lastly, the -- it was interesting that NovoCure was breaking out Germany revenue for this quarter and the other active markets contributing nearly $8 million.

Is this to say that the overall EMEA markets did $23 million in the quarter? And was there any incremental revenue from France in the quarter? Thank you..

So -- hi. It's Asaf. I will start with PANOVA. So we are on track. We still planning to do the interim [ph] as soon. And I think the rest of the question is, Ashley [indiscernible]..

So I mean I'll just reiterate that we are also on track with the INNOVATE enrollment. And we're in that patient follow-up period, and that should end in the back half of this year, mid this year, I would expect data to come out. No change in those expectations to be very clear. Things are progressing as expected.

When we talk about revenue, that has also no change. This was simply an internal adjustment to our international market franchise structure. Germany has always been broken out in its own line item under EMEA, it's now broken out in its own line item standalone. There are no non-EMEA markets in other.

Japan is our only active market, currently outside of EMEA in the U.S., so that you can tie others to other EMEA in prior Qs. So I appreciate that question. I will note that we do not yet have revenue in France. We are treating patients.

So we have active patients in that market, but it will take us a couple of quarters before you see the material revenue come through as we just go through this administrative ramp up and look to see a successful conclusion of collection cycle..

Thank you. [Operator Instructions] And our next question comes from Vijay Kumar of Evercore ISI. Your line is open..

Thanks. This is [indiscernible] for Vijay. Just back on the topic of ASCO, can you remind us again, will we get to learn PD-1 expression status of patients then? And second, on OpEx in the quarter, specifically on SG&A. There seems to be a large increase.

How much of this increase were, say, new hires focused on new markets and new indications versus current existing markets like GBM? Thanks..

Good morning and thanks for your question. And I'm just going to underlying for everybody that the LUNAR data presentation will be Tuesday, June 6, at 11:09 in the metastatic non-small cell lung cancer.

And yes, I'll repeat, we will provide the PD-L1 data from the trial during that presentation and take Q&A with respect to all of the parameters in our session to be held later that afternoon.

And Ashley?.

Yes. And on the SG&A, I would say as we look at growth in SG&A, there's almost exclusively related to growth in our markets, whether that's geographic expansion for our existing GBM business or its preparation for commercial launches in lung, ovarian and hopefully pancreatic in the future.

So I would say we do appropriately resource our existing GBM business in our active markets of today, but we feel like they are adequately resourced. And so increments there are focused on opening up fronts and opening up early commercial opportunities in lung and beyond..

Thanks..

Thank you. I would now like to turn the conference back to Bill Doyle for closing remarks..

So I want to thank everyone for joining us this morning and your continued support of NovoCure. It's hard to convey over the phone what an exciting time it is to be at NovoCure. We are really thrilled with the way our efforts in the market are beginning to bear fruit, both in terms of geographic expansion, increases in scripts.

We didn't talk about it much on this call, but we are thrilled with what we're seeing with our launch of our next-generation arrays. We think this is very important. And the early read from Austria and Sweden is that this is a great product and we're focused on rolling this out now across Europe and getting the PMA supplement in the U.S.

so we can roll out here following regulatory approval. And then, of course, the new indications. We are pioneering this new modality. We have been talking about the broad application based on our 23 years of R&D and we're really now on the threshold of bringing it to patients. So thank you all..

Thank you. This concludes today's conference call. Thank you for participating, and you may now disconnect..