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NovoCure Limited (NVCR 0.33%)
Q1Â 2019 Earnings Call
May. 02, 2019, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, ladies and gentlemen, and welcome to the Novocure First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this call is being recorded.
It is now my pleasure to introduce, Senior Vice President of Finance and Investor Relations, Ms. Ashley Cordova.
Ashley Cordova -- Senior Vice President of Finance and Investor Relations
Good morning everyone and thank you for joining us to review Novocure's First Quarter 2019 performance. I am joined today by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; our CFO, Wilco Groenhuysen; and our Chief Medical Officer, Ely Benaim.
The slides presented today, can be viewed on our website www.novocure.com, by clicking on the link for first quarter 2019 financial results, located in the Events section on our Investor Relations page. Before we start, I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control, including those risks and uncertainties described from time to time in our SEC filings.
We do not intend to update publicly any forward-looking statement except as required by law. Following our prepared remarks today, we will open the lines for questions. Financials for the three months ended March 31, 2019, are available in our press release and in our 10-K, both of which we released earlier this morning. With that, I will now turn the call over to Bill Doyle.
William F. Doyle -- Executive Chairman
Thank you, Ashley and good morning everyone. With more than 2,600 patients on Optune as of March 31, 2019, we delivered another quarter of strong financial performance. We posted $73.3 million in net revenues representing 41% growth versus the first quarter of 2018. Our clinical pipeline continues to advance, creating a significant market expansion opportunity. Our HDE application for malignant pleural mesothelioma is under review with the FDA and with the first patients enrolling in our INNOVATE-3 trial in March, enrollment is now ongoing in four Phase 3 pivotal trials. Data read-outs from these trials are expected beginning in 2021. In addition to the compelling value creation potential of our advancing pipeline, we have several catalysts in 2019 to fuel continued top-line growth. We expect a decision from CMS regarding our coverage reconsideration request for newly diagnosed GBM in the Medicare population, and we expect a decision from the FDA regarding our HDE submission for malignant pleural mesothelioma. In addition, Zai Lab is working to obtain the trial waiver for regulatory approval of Optune in China for newly diagnosed and recurrent GBM this year, and is actively preparing for a potential launch.
I'll delve into these three catalysts specifically before handing the call over to Asaf for a commercial update. We continue to work with payers to expand access to Optune for patients with GBM. As of March 31, 2019, more than 245 million Americans had coverage of Optune for newly diagnosed and/or recurrent GBM. Medicare is the sole remaining large US payer who consistently denies coverage for Optune. As a reminder, 20% to 25% of our US active patient population are beneficiaries of the Medicare Fee-for-Service program. In the fourth quarter of 2018, the Medicare DME MACs accepted our local coverage decision reconsideration request for the treatment of newly diagnosed GBM.
Novocure is the first company to progress through a recently updated DME MAC process that reflects policy changes in response to the 21st Century Cures Act. In conformance with the updated process, the DME MACs met in March with the Contractor Advisory Committee or CAC intended to inform the healthcare professional community of the evidence used in developing coverage determination and to promote communications between Medicare and the healthcare professional community. The CAC presentation and discussions centered on the strength of the scientific data and the general acceptance of Optune for the treatment of newly diagnosed GBM by the healthcare professional community. At the conclusion of the day, the CAC panel expressed their confidence that there is sufficient evidence to determine that Optune provides net positive health outcomes in the Medicare eligible population. We believe the CAC process was a positive step forward in a multi-step process. The DME MACs are now working to draft a proposed Local Coverage Decision or LCD for newly diagnosed GBM. Per CMS policy, the two DME MACs will issue a single joint LCD policy applicable in all the EMEA regions. The timing of the publication of the proposed LCD is not specified by CMS policy guidelines. It was published the proposed LCD will be subject to a 45-day public comment period and following that public comment period, a final LCD will be published. As a reminder, our decision to file for coverage followed the announcement by CMS that it had developed the methodology that will recognize commercial pricing for newly covered DME and that commercial pricing information will be taken into account when establishing a new fee schedule amount.
Moving to mesothelioma, we submitted a Humanitarian Device Exemption or HDE application to the FDA in October 2018 for approval in malignant pleural mesothelioma based on the successful completion of our STELLAR trial. The STELLAR trial demonstrated a significant extension of median overall survival to 18.2 months for patients treated with Optune plus pemetrexed and cisplatin or carboplatin. No serious device-related adverse events were reported. We received comments from the FDA on our HDE application and submitted a response in March. The FDA has 75 days until mid May to review our response and act on the submission. Our discussions with the FDA have been constructive and our US commercial teams are preparing for a 2019 launch.
In the United States, the majority of mesothelioma patients are treated at approximately two dozen centers of excellence. We are currently in the process of hiring five mesothelioma territory managers to call on the multi-disciplinary teams at these centers. Pending regulatory approval, their primary call point will be the radiation oncologists certified to prescribe Optune for mesothelioma. They will also work to educate medical oncologists and support the Institutional Review Board approval process required under the HDE approval pathway. Upon approval, we will begin our dialog with payers for coverage of malignant pleural mesothelioma. Positive coverage policies for GBM will not apply to mesothelioma and we anticipate the claims during the early launch phase will go through an appeal process with payers, similar to our early experience with GBM.
Another 2019 catalysts for growth is the potential approval of Optune for GBM in China. As a reminder, we announced the license and collaboration agreement with Zai Lab in the third quarter of last year. Zai has begun to treat commercial patients in Hong Kong and has taken steps to progress the regulatory filing for Optune in China. Zai is seeking a trial waiver from the Chinese regulatory authorities enabling a potential launch in China as early as the fourth quarter of 2019. On the clinical development front, Zai is working to finalize the protocol for a Phase 2 pilot trial in gastric cancer and is collaborating closely with our clinical team to initiate trials in other key indications in China.
I will now hand the call over to Asaf to review our first quarter commercial execution.
Asaf Danziger -- Chief Financial Officer
Thank you, Bill. Active patients, our main revenue driver grew, by 248 from 2,383 at year-end to 2,631 at the end of Q1. The number of prescriptions for patients with newly diagnosed GBM, our main driver of active patients, also continued to grow. We added strong total prescription growth in Germany and Japan. The total number of prescriptions in the US was affected by a decrease in the number of prescriptions for recurrent GBM which fluctuate quarter-over-quarter. Physicians are the primary source of information on treatment options for GBM patients. We believe the strength of physician recommendation often influences whether or not a patient will start up Optune. Also, the confidence and communication skills of individual prescribers at key centers can have a noticeable impact on our prescription flow. We have developed specific marketing resources to enhance communication across the multi-disciplinary teams at cancer treatment centers, and to prepare physicians to confidently recommend Optune to patients. We believe these new marketing resources already are having an impact in the field. I met with a radiation oncologist at the hospital in Bavaria recently, who shared his personal experience. Our account managers call on the multi-disciplinary treatment teams at cancer centers. At his center, German presentation on the importance of physician-patient-communication made an impression on the neurosurgeon. This neurosurgeon is now routinely educating patients about opportunity during his pre-surgery consults. As a result of this early education, the radiation oncologist who sees the patients after surgery finds it much easier to present Optune to patients and has seen a noticeable increase in early patient acceptance. We are rolling out similar programs globally.
In Q1 2019, we drove 41% revenue growth compared to Q1 2018. In parallel, SG&A expenses grew by only 20%, reflecting our continued commitment to delivering operating leverage in our commercial business. Our R&D investments grew 53% compared to the first quarter 2018 as we now have four Phase 3 pivotal trials and one Phase 2 pilot trial open and enrolling. Notably, we continue to fund increased investments in our clinical pipeline and technology development with cash flow from the GBM business.
With that, I will now turn the call back over to Bill, for an update on our pipeline.
William F. Doyle -- Executive Chairman
Just last week, the International Journal of Radiation Oncology, Biology and Physics known in the field as the Red Journal published data demonstrating that higher doses of tumor treating fields improved survival of newly diagnosed GBM patients. This publication represents the first peer-reviewed analysis demonstrating patient level dose response to Optune. It provides a rigorous definition for tumor treating fields dose and sets a framework for future work on tumor treating fields dosimetry and treatment planning. The Red Journal is the Official Journal of the American Society for Radiation Oncology and we believe that this prestigious publication will drive increased awareness of tumor training fields and the important role of treatment planning with the radiation oncology community. In order to further advance the scientific evidence supporting the use of Optune in GBM and gather additional information about Optune's optimal use, we plan to initiate two additional randomized trials in GBM starting as early as 2019.
The first trial will be designed to study the potential benefit of initiating Optune with radiation therapy versus initiation post radiation and it is intended to support possible label expansion. The trial will mirror the design previously contemplated in the GdA (ph) trial. We believe this trial will add key evidence supporting further adoption by radiation oncologists, a key customer segment for Optune. The second trial will be designed to identify potential efficacy signals when Optune combined with temozolomide and several other therapeutic agents in a multifactorial trial design and is intended to identify optimal combination treatments. While the treatment of GBM provides an important opportunity for Novocure to improve patient outcomes and grow revenue. We believe it represents the tip of the iceberg for the company. We enrolled the first patients in our Phase 3 pivotal INNOVATE-3/ENGOT-ov50 trial in ovarian cancer during the first quarter 2019. The INNOVATE-3 trial will study Optune in combination with weekly paclitaxel in 540 patients with platinum-resistant ovarian cancer. Both the European Network for Gynecological Oncological Trial groups or ENGOT and the US based GOG Foundation are collaborating with us on INNOVATE-3. ENGOT and GOG were involved in the development of the trial and the collaborations are intended to promote the INNOVATE-3/ENGOT-ov50 trial and to guide and facilitate enrollment at leading cancer centers in Europe and the United States. We are extremely pleased to partner with such respected third party clinical trial networks and view their association with Novocure as a sign of the increasing interest in Optune from the clinical community. We continue to perform basic research on tumor treating fields as do members of the scientific community. At the American Association for Cancer Research Annual Meeting 2019, in late March, there were 48 presentations and a major symposium on tumor treating fields. We announced six Inaugural AACR-Novocure Tumor Treating Fields Grant Recipients in a noteworthy partnership that will provide critical resources to accelerate progress in the expanding field of tumor treating fields research. Our teams came back from AACR energized, attendance at tumor training fields poster presentations and symposium were good and our team believes the questions received reflected genuine interest in the mechanism of action and a shared desire to better understand how tumor treating fields could extend survival in some of the most aggressive forms of cancer.
With that, I will turn the call over to Wilco to review our first quarter financial results.
Wilco Groenhuysen -- Chief Financial Officer
Thank you, Bill and thanks to everyone for joining us on the call this morning. Novocure delivered another quarter of strong financial performance. First quarter net revenues were $73.3 million growing 41% year-over-year and growing 5% quarter-over-quarter. Year-over-year revenue growth was driven by an increase of 622 active patients representing 31% growth and an increase in the net revenues per active patient. The year-over-year increase in net revenues per active patient was primarily driven by improving reimbursement approval rates in Germany and by growth in Austria and Japan. With more than 2,600 patients on therapy as of March 31st 2019, the number of active patients on Optune has grown for 17 consecutive quarters since the initial presentation of our EF-14 data in newly diagnosed GBM. We expect to continue to see active patient growth driven by the steady growth in newly diagnosed prescriptions globally over the prior 11 quarters. Gross profit in the quarter was $53.5 million, reflecting a 73% gross margin. Gross margin continues to benefit from increasing scale and ongoing efficiency initiatives. We are working hard to sustain and improve this key metric. Moving down the income statement, we continue to increase investments in research and development with $17 million in R&D expenses in the quarter, up more than 50% versus the first quarter of 2018. As we're working to enroll patients across four Phase 3 clinical programs, we anticipate that R&D expenses will continue to increase in future quarters. Our first quarter SG&A expenses were $42.6 million, including $8 million in non-cash share-based compensation. SG&A expenses include increased marketing expenses to support Optune adoption and increases in our sales force globally.
Our first quarter operating loss of $6.1 million, and includes $17 million in R&D investments. Net loss for the quarter was $12.2 million or $0.13 per share. We ended the first quarter with $256.6 million in cash, cash equivalents and short-term investments, an increase of $10.7 million from the prior quarter.
Net cash flow used in operations was $4.3 million and we believe we have an extended cash runway that provides Novocure with financial stability and flexibility as we execute our core strategies. We believe Novocure has reached an important inflection point, transitioning to cash generation, expanding globally and working to extend survival in some of the most aggressive forms of cancer.
With trailing 12-month revenues approaching $270 million, five indications in our late-stage pipeline and a strong balance sheet, we believe we are well positioned to deliver both continued near-term revenue growth and significant growth in long-term shareholder value.
Thank you for your time this morning. Now, I will turn the call back over to the operator for questions.
Questions and Answers:
Operator
Thank you. (Operator Instructions) And our first question comes from the line of Vijay Kumar with Evercore. Your line is now open.
Vijay Kumar -- Evercore -- Analyst
Hey guys, thanks for taking my question. Maybe I'll start with the CAC panel. It looks like from your comments, you sound quite positive, I'm just curious, have you had any contact with the DME since the CAC panel and what -- maybe flesh out why you guys feel confident on the CMS reimbursement coming through possibly in the back half?
William F. Doyle -- Executive Chairman
Sure. So, thanks very much for the question. This has obviously been a focus of ours, as was described in the opening remarks. Over 245 million Americans have coverage for Optune, but the group that doesn't are the Medicare Fee-for-Service beneficiaries. So this has been a principal focus of ours. Historically, we have focused to help Medicare develop a process for what they now call novel DME. This is quite different from what they used to focus on which are beds and canes and that sort of thing. And it was a key milestone for us when they changed their guidance to include commercial pricing in their coverage approach. That triggered our filing of the LCD request for coverage and we filed just as CMS was changing their practices for evaluating these sorts of request. So, we are the first company going through this new process. A key part of that process is the convening of the CAC. So, this was the first DME CAC, it was an interesting group, the group that was assembled was -- did not include the EF-14 investigators, but nonetheless, we presented to the group that did not have a lot of prior knowledge about tumor treating field, and at the end of the day, they voted to support and determined that there was sufficient evidence that Optune provides a net positive health outcome for the Medicare eligible population. So that was the desired goal of that meeting, we achieved it. And now, the next step is the drafting of the LCD itself. We believe this is under way at CMS, and that will be followed by the public comment period.
I'll just make one note with respect to the public comment period. We do expect tremendous support during the public comment period. All of the relevant patient advocacy organizations have already been in touch with us to determine how they can best support us and so we think that the process will unfold and that's why we're still, remain confident that this will happen in 2019.
Vijay Kumar -- Evercore -- Analyst
That's helpful, Bill. And then maybe on the script volumes which -- the street focuses on, it's becoming slightly more challenging for the street to model out and I understand there is a new versus recurrent GBM dynamic going on, but I guess just from a headline perspective, when we look at the active patient growth, which has been growing well above script volumes. Maybe just flesh out some of the dynamics here to give some confidence for the street on the script volume growth, particularly on the new GBM side and why that active patient revenue growth in the medium term should remain healthy?
William F. Doyle -- Executive Chairman
Sure. So first of all, thanks for this question that I want to be -- I do want to clarify this issue for everyone on the call. I'd encourage everybody to take a look at Slide 4 of our earnings presentation that shows the trends in newly diagnosed GBM prescriptions. So of course, our -- as you call it headline prescription number consists of prescriptions for newly diagnosed GBM and for recurrent GBM. For us as a company, we are driving growth and the way our team works is to drive growth in newly diagnosed scripts.
This is the point during the evolution of GBM, when Optune can have the most benefit for the patients. It's also the point during which the patients will remain on therapy for the longest period of time and of course, that's what drives our revenue. So we encourage everyone to first and foremost, focus on active patients, that is the key revenue driver. With respect to prescriptions, I would also focus on newly diagnosed where we've seen growth in Q1 versus Q1 last year and also growth versus Q4 last year.
The fluctuation is in recurrent GBM, which will continue to fluctuate up and down, but one thing I would like to emphasize here is that we count only one script per patient. So when we get a newly diagnosed patient and they start therapy, those patients will typically continue on Optune therapy, when they, or if they progress, we don't count that script a second time.
So another way to think of it is every time we get a newly diagnosed patient script, we get one for newly diagnosed and we get a second one for recurrent GBM. We don't count them that way, but that is really why we see the strong growth in patients on therapy. We expect to continue to see that growth even though the recurrent scripts will fluctuate quarter to quarter.
Vijay Kumar -- Evercore -- Analyst
That's helpful. And maybe one last one from me, gross margins here in Q1 really strong. Maybe some color on were there any one-off items on the gross margin line for Q1? How should we be thinking about this gross margin? Is this the new run rate level that we should be thinking about? Thank you.
Wilco Groenhuysen -- Chief Financial Officer
Yeah good morning, Vijay, this is Wilco. There's no one -- the good news is no one-time benefit that affected the gross margin positively. As we said during the script, it's a consequence of increasing scale, which is of course a beneficial impact on gross margin, but also our ongoing efficiency initiatives are bearing fruit if you want. So, the 73% gross margin is not appropriate (ph) , it is a result of hard work and is sustainable.
Vijay Kumar -- Evercore -- Analyst
Thank you guys.
Operator
Thank you. And our next question comes from the line of Cory Kasimov with JP Morgan. Your line is now open.
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
Hi, this is Arun on for Cory. Thanks for taking my questions. I have couple of questions for you. The first one is commercial related question. Can you talk about the -- what fraction of sales have come from recurrent versus frontline GBM setting? And what's the duration of treatment in each of the respective settings? And I have a follow-up for you.
William F. Doyle -- Executive Chairman
Okay. So I think the question related to the differences between the first line and the second line setting, is that correct?
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
Yeah, what fraction of sales have come from the recurrent as well as the frontline setting?
William F. Doyle -- Executive Chairman
So in terms of active patients, approximately, today 75% of those patients are newly diagnosed GBM and approximately 25% our recurrent GBM. Pardon me, in terms of --.
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
And can you also talk about the duration of treatment in each of this respective settings?
William F. Doyle -- Executive Chairman
Sure. So the duration in the recurrent setting remains approximately four months. Actually the duration of therapy in the newly diagnosed has trended up a little bit to about nine months and we're seeing an average duration in the mix of between 7.5 and eight months.
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
And my second question is related to the commercial readiness. I know that you have mentioned in your prepared remarks regarding the approval in mesothelioma setting. So, could you please talk about how we could leverage from the existing GBM sales force in preparing for the launch, in that particular setting?
Asaf Danziger -- Chief Financial Officer
So, thank you very much for the question. It's Asaf. First of all, I would like to say that the mesothelioma indication is a very important indication for us. It's the first indication outside the head, the brain. We are not going to basically sacrifice any sales forces from the GBM and -- our current plan is to hire another five territory managers and it's going to be -- in the same sales (ph) organization, but it's going to be people that will focus on mesothelioma.
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
Okay, thank you.
Operator
Thank you. And our next question comes from the line of Larry Biegelsen with Wells Fargo. Your line is now open.
Lawrence Biegelsen -- Wells Fargo -- Analyst
Hey guys, good morning. Thanks for taking the question. On the Medicare process here, when do we learn about the pricing and how should we think about that today versus commercial?
William F. Doyle -- Executive Chairman
So, as I mentioned, Larry, our decision to file for coverage followed the CMS announcement that it did develop this new methodology to recognize commercial pricing. We have submitted our commercial pricing data to Medicare, so they have that. The fee schedule amount will be assigned to our current hick picks code and we would expect that information to come after the LCD reconsideration. So we are -- at Novocure very focused on both of course, but we would expect that information, the pricing information to come after the LCD.
Lawrence Biegelsen -- Wells Fargo -- Analyst
Bill, just to be clear, after the final LCD comes out, then we'll learn about pricing or is it before the final LCD?
William F. Doyle -- Executive Chairman
We believe it's after.
Lawrence Biegelsen -- Wells Fargo -- Analyst
Okay, that's helpful. And then on the METIS trial, could you please give us an update on enrollment and I know the data release timing is 2021. Just any color, any, a little more precision on when we might see that data. I know it slipped a little bit from initially 2020 to maybe early 2021 in the recent past, but just a little more recent updated precision on that? Thanks for taking the questions guys.
William F. Doyle -- Executive Chairman
Yeah. So, Larry, the recruitment now is ongoing at about 100 sites. So we now have all the sites opened and enrolling. We don't report, as you know, sort of a scorecard on recruitment, but we feel that this is proceeding as we hope it will proceed and we think we're in good shape.
Lawrence Biegelsen -- Wells Fargo -- Analyst
Just let me slip one more in there. Reimbursement in Germany, any update there? And I'll drop. Thanks for taking the questions guys.
Wilco Groenhuysen -- Chief Financial Officer
Yeah, Larry, Wilco here, good morning. There is no real update as we said in prior quarters. The case by case reimbursement in Germany has developed strongly as based on the data of TTFields, national reimbursement, we don't believe will have a material impact on the overall reimbursement in Germany. So the application is progressing according to the timelines that were set, we think it will probably lead to a positive outcome, but it's not on a case-by-case basis, we're successful as well.
Lawrence Biegelsen -- Wells Fargo -- Analyst
Thanks Wilco.
Operator
Thank you. And our next question comes from the line of Greg Fraser (ph) with SunTrust. Your line is now open.
Greg Fraser -- SunTrust -- Analyst
Good morning, folks. Thanks for taking the questions. This is Greg Fraser on for Gregg Gilbert. Just want to follow up on the prescription growth and you talked about the decline in recurrent patients. Can you just comment specifically on the US market and what prescription growth was for new diagnosed patients in the US in the first quarter?
William F. Doyle -- Executive Chairman
Sure. No, we don't break down the prescriptions by region in that way, but we do see that it is consistent across regions.
Greg Fraser -- SunTrust -- Analyst
Okay. For Medicare, assuming you do get the Medicare coverage for the roughly 25% of patients that are in Medicare that are already being treated, will the positive coverage decisions apply to those patients as they continue on therapy?
William F. Doyle -- Executive Chairman
Yes. We believe that from the point that becomes active, it will apply to the patients who are currently receiving therapy and new patients as they become active patients. Yes.
Greg Fraser -- SunTrust -- Analyst
Got it. And my last question is on reimbursement for EMEA. Specifically for Israel and Switzerland, could you just give us an update on where you stand in discussions with those countries and whether there are any important decision points coming this year?
Asaf Danziger -- Chief Financial Officer
Hey, it's Asaf. Thank you for this question. So in Israel, once a year, this review of what we call the national reimbursement basket and we hope that and it's happened in December, so we hope that we will get reimbursement, national reimbursement in Israel. However, we do start to use the German model in Israel and we hope that we will see in the future (inaudible) patient by patient reimbursement. In Switzerland, we are in the middle of the process that which review the package, so we are in ongoing interaction with the authorities in Switzerland.
Greg Fraser -- SunTrust -- Analyst
Thank you.
Operator
Thank you. And our next question comes from the line of Difei Yang with Mizuho Securities. Your line is now open.
Difei Yang -- Mizuho Securities -- Analyst
Hi, good morning and thanks for taking my question. So just a couple. The first one is on China. I apologize you may have commented, I got on the phone a little later. So with regards to China, for the trial waiver, is that specifically related to GBM?
William F. Doyle -- Executive Chairman
Yes.
Difei Yang -- Mizuho Securities -- Analyst
Okay, thank you. And how does the gastric cancer still for the arrays that pull down the gastric cancer is at more or less similar to mesothelioma configuration or is it drastically different?
William F. Doyle -- Executive Chairman
No, so the torso arrays whether they are for mesothelioma or the abdominal applications, they're all similar. In the brain, we have one size array; in the torso, right now we have two size arrays to accommodate different body shapes. They're based on the same technology and they're essentially just different size configurations of the same technology.
Difei Yang -- Mizuho Securities -- Analyst
Okay, thank you. And then the next question is with regard on the innovation side, I think we have heard about the energy density and the impacts -- and its impact on the clinical outcome. How should we think about timing with regard to the next generation array updates or battery updates, et cetera?
William F. Doyle -- Executive Chairman
Sure. So again as we described today, we were very pleased that the Red Journal has now published the data from EF-14 demonstrating dose response. This analysis now gives us the tools to do just as you describe to further improve first the arrays, the system and also our NovoTAL array planning system. So we have efforts focused on all of those. I think it's too early for us to predict exactly when these various innovations will become available for patients and I expect they will come not all at once, but in a series of improved releases over time.
Difei Yang -- Mizuho Securities -- Analyst
Thank you and congrats on the great quarter.
William F. Doyle -- Executive Chairman
Thank you.
Operator
Thank you. And I'm showing no further questions at this time. So with that, I will turn the call back over to Executive Chairman, Mr. Bill Doyle, for closing remarks.
William F. Doyle -- Executive Chairman
So we were very pleased to provide another strong quarter at Novocure. We provided progress both in terms of our commercial objective, which is to bring Optune therapy to all the GBM patients in the world who can benefit and within our pipeline to expand the availability of tumor treating fields therapy to a number of the most difficult to treat cancers. I think now with four Phase 3 trials under way, a second Phase 2 trial under way and additional trials planned, as you heard additional trials in GBM as well as additional indications, we think Q1 provided us with a strong foundation for the year. We didn't get a question about this, but I will also note our cash balance has continued to increase and we're pleased that we're now transitioning to a cash flow generating company so that we can support all of these efforts in the pipeline and in improving the technology with cash generated from our business. So thank you for your interest in Novocure and we'll get back to Q2. Thank you.
Operator
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day.
Duration: 39 minutes
Call participants:
Ashley Cordova -- Senior Vice President of Finance and Investor Relations
William F. Doyle -- Executive Chairman
Asaf Danziger -- Chief Financial Officer
Wilco Groenhuysen -- Chief Financial Officer
Vijay Kumar -- Evercore -- Analyst
Arun Kiran Pasumarthy -- JP Morgan -- Analyst
Lawrence Biegelsen -- Wells Fargo -- Analyst
Greg Fraser -- SunTrust -- Analyst
Difei Yang -- Mizuho Securities -- Analyst
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