VolitionRx Limited (AMEX:VNRX) Q4 2023 Earnings Call Transcript
VolitionRx Limited (AMEX:VNRX) Q4 2023 Earnings Call Transcript March 26, 2024
VolitionRx Limited isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Year 2023 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. [Operator Instructions]. This conference call is being recorded today, March 26, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
Louise Batchelor: Thank you, and welcome, everyone to today's earnings conference call for VolitionRx Limited. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements.
We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call. I am joined today by Mr. Cameron Reynolds, President and Group Chief Executive Officer, Mr. Terig Hughes, Group Chief Financial Officer Doctor, Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary and Dr. Andrew Retter, currently Medical Consultant to Volition, which has recently announced due to join Volition n the role of Chief Medical Officer in April 2024. During the call, we will cover Volition's financial and operating results for the fourth quarter and full fiscal year of 2023, along with a discussion of our recent activities and upcoming milestones.
Following our prepared remarks, we will open the conference call to a question-and-answer session. I'll now turn the call over to Cameron Reynolds. Cameron?
Cameron Reynolds: Thanks Lou, and thank you, everyone, for joining Volition's fourth quarter and full year 2023 earnings call today. We appreciate your time given the busy annual 10-K filing season. We will commence the call with a financial report from our Group Chief Financial Officer, Terig Hughes, before moving on to a prerecorded update from Dr. Tom Butera, Chief Executive Officer of Volition Vet on the rollout of our Nu.Q vet cancer test. And I'm delighted to welcome Dr. Andy Retter to the call to provide an update on the Nu.Q NET and Capture-PCR. As was announced last week, Andy will be joining Volition as our Chief Medical Officer beginning April 1st. Many of you will have heard from Andy previously, but I'd like to formally share his credentials.
Dr. Butera is an intensive care consultant at Guy's and St Thomas' NHS Foundation Trust in London, where he has worked as a consultant since 2014 and leads clinical governance in critical care. He specializes in the management of severe respiratory failure, ECMO and thrombosis. Dr. Butera is the only consultant in the UK to hold dual entry on the specialist register in Intensive Care and Hematology and provides national guidance on the management of complex hematology patients in clinical care. He will continue his clinical and research duties at Guy's and St Thomas' NHS Foundation Trust after joining Volition. Dr. Butera has worked with Volition in an advisory capacity since January of 2022. To help guide the product development and clinical utility of Nu.Q NET's, a CE-Marked routine blood test to detect disease associated with NETosis, such as sepsis.
The whole team are absolutely delighted to be welcoming Andy more formally into Volition. As Chief Medical Officer, he will be vital to our success, ensuring the needs of the patient are placed at the heart of our research, development and commercialization activities. It's great to have you on board, Andy. And I must say your enthusiasm for our mission and platform really helps us to fully understand the great importance of the work we do. Following Andy's update, I will wrap up with my thoughts and upcoming milestones and discuss our overall strategy going forward. Without further ado, I'll hand you across to Terry for our financial report. Terry?
Terig Hughes: Thanks very much, Cameron, and thank you everyone for joining our earnings call today. I'll now provide a summary of the key financial results for the quarter ended December 31 full year 2023. From a revenue perspective, we recorded revenue of $244,000 for the quarter, a 104% increase over the same period last year. For the full year 2023, we recorded revenue of $775,000 an increase of 153% over the prior year. We believe that these results demonstrate steady progress, but not yet the ramp in revenues that we anticipate. We expect revenues to accelerate in 2024 as several additional distributors come online with our Nu.Q vet cancer test, in particular, Antech and FujiVet who are both about to launch and our Nu.Q discover pipeline continues to grow.
2023 full-year revenue of the Nu.Q Vet cancer test was $475,000 a year-on-year increase of 194%, mainly reflecting sales of reference kits through our agreement with IDEXX. Revenues in Nu.Q discover for 2023 was $300,000, which reflects 107% growth over 2022. Moving on to the balance sheet. We ended the year with cash and cash equivalents of approximately $20.7 million compared with $10.9 million at the end of 2022. Net cash generated from operating activities during the fourth quarter 2023 was approximately $6.4 million and reflected the receipt of $13 million in milestone payments from Heska Corporation in December. For the full year 2023, net cash used in operating activities was $18.1 million, compared to $15.3 million in the prior year.
Net loss for fourth quarter 2023 was $8.8 million, compared to $7.3 million for the fourth quarter 2022 and for the full year, $35.7 million, compared to $30.6 million in 2022. This increase was primarily the result of increased Research & Development expenditures mainly reflecting the cost of our U.S. clinical trials which added $3.1 million to the P&L costs in 2023. To date, various European funding bodies and in particular, Belgian agencies have committed to the company over $21 million in non-dilutive funding in various forms, including cash grants and loans on favorable terms. In the fourth quarter, our Walloon institutional fund and regional government bodies of the Walloon region of Belgium committed additional funding to the company aggregating approximately $5.5 million of which approximately one half was in the form of a loan.
We would like to publicly thank the various government agencies of Belgium for their continued support. We have also initiated efforts with respect to seeking non-dilutive funding in the U.S. Our aim is to fund some of our major programs through either non-dilutive or project financing, which we anticipate could be substantial over the next two years. As mentioned earlier, at the end of fourth quarter, we received $13 million in milestone payments from Heska Corporation, now an Antech company and part of Mars Petcare, one of the largest pet health companies in the world. And so, to recap, we ended the year with cash and cash equivalents of $20.7 million. With that said, I believe that we are well-placed to execute the plans the team have in place for 2024.
And with that, I will pass over to Dr. Tom Butera, CEO of our Volition Veterinary subsidiary. Tom?
Tom Butera: Thanks very much, Terig, and good morning everybody. In 2023, we supplied kits and components for over 58,000 tests, 5 times the number in the prior year. This growth demonstrates solid progress to date and we certainly expect more growth to come as additional companies fully launch our product at home in the United States and around the world. By the end of 2023, the Nu.Q Vet cancer test was available in the United States, the United Kingdom, and Ireland, Portugal, Singapore, Taiwan and Italy. 2023 was a breakthrough year for Volition Veterinary gaining such wide distribution and with such respected companies, so kudos to the team and a special thanks to our legal department. We have also learned a great deal, launching and introducing a new product in veterinary medicine, especially early cancer detection in dogs takes a tremendous amount of education to teach veterinarians how to incorporate this early cancer dialogue into their routine wellness visits.
Our Nu.Q test also requires an additional cost to the client, which is part of our educational conversation in teaching doctors how to easily make this part of their wellness office visit Additionally, we are always emphasizing the affordable cost of our test and encouraging doctors to keep the test at very reasonable margins. The fact is clearly related to the very large number of dogs that they will be screened for early cancer detection. All-in-all, I believe our Volition team will look back on 2023 as a proud pivotal moment in the burgeoning field of early canine cancer detection, setting the stage to improve and extend the lives of millions of dogs in the months years to come. We have also launched the Nu.Q test with IDEXX, one of the world's leading veterinary diagnostic companies and now Heska, an Antech company and part of Mars Petcare, another leading veterinary company in completing the exciting tech transfer onto the Heska Element I+ in-house diagnostic platform.
More recently, as you will have seen in an announcement just last week, we have signed a supply agreement with Fujifilm Vet Systems for our Nu.Q Vet Cancer Test in Japan. Indeed, I have prerecorded my update for today's call as I am currently over in Japan with our colleagues from Fuji and Wow! What an incredible event this last week. We were delighted to be deeply engaged with our Fuji colleagues at their veterinary booth located at the World Veterinary Cancer Congress in Tokyo. This event also provided a significant exposure to numerous veterinary cancer specialists from around the world. We believe that Japan is a considerable market opportunity for Volition as we seek to expand our Nu.Q Vet Cancer Test offering in Asia and Fuji is a great partner with us.
Fujifilm Vet Systems as Japan's leading veterinary diagnostic laboratory service with a network of 10 laboratories serving more than 90% of the 12,000 veterinary clinics and hospitals nationwide in Japan. As a reminder, our test is a simple, affordable, easy to use blood-screening test that can be easily integrated into preventive care programs and used alongside other routine blood work during regular wellness visits. We had an incredibly busy time at the Fuji booth and have been excited not only to see the response to the test, but also to hear about the exciting marketing plans Fuji has in place to drive the adoption of Nu.Q. Heather also had the privilege of presenting a poster about the Nu.Q Vet Cancer Test at the Congress. It's been a busy few days and we look forward to working alongside Fujifilm Vet Systems as they roll out our test countrywide across their extensive diagnostic laboratory network.
We are also incredibly excited that the Nu.Q Vet cancer test will soon be available as an in-house diagnostic via Heska and Antech company. We understand preorders are currently being processed and the test will be rolled out fully at their upcoming national sales meeting at the end of this month. Soon veterinarians will have accurate in hospital fast test results in under eight minutes, so that they can discuss findings with pet owners and hopefully develop an action plan before the patient even goes home. Antech is initially pricing the test at $35 to the veterinarian and we really believe that the relatively low cost combined with the effectiveness of our test will help drive adoption of the test not only as a screening test, but also in time as an important monitoring tool for disease progression and remission.
So, to quote Cameron, very exciting times indeed. That's a quick update for me given our packed agenda today. I will now with absolute great pleasure hand over to our incoming Chief Medical Officer, Dr. Andrew Retter. Andy is a fabulous addition to our leadership team. Andy, over to you for an update on Nu.Q NET.
Andrew Retter: Thank you very much for those kind words, Tom, and good morning, everybody. I'd just like to take a moment to start by thanking Cameron, Jake and the Board of Directors for working with me and inviting me to join the Volition team at such an important time. I've really enjoyed working with Volition for the last two years, and I'm really excited about leaning into and contributing to delivery of our mission purpose in the years to come. We really hope to have an impact to improve the lives and quality of lives of millions of people worldwide. I'd like to update you this morning on some of the significant progress we've made with Nu.Q NET and our new breakthrough cancer detection method, which we now call Capture-PCR.
So first, starting with NETosis and sepsis. Sepsis, as you've heard me say before, is one of the leading of causes of death worldwide with almost 50 million cases annually and around 11 million deaths. Physicians made significant progress trying to address these issues in 2023, and I'd just like to recap a few highlights. In September, Volition hosted a key opinion leader roundtable event in Athens, Greece. The workshop held over the course of two days focused exclusively on sepsis and the potential role of Nu.Q NET is attended by some of the world's leading experts. Many of the attendees are operating under the umbrella of our Center of Excellence program with Nu.Q NET and have firsthand experience using assay now. The sense from the group was that Nu.Q NET potentially represents one of the biggest breakthroughs in the diagnosis and monitoring of sepsis in the last 30 years.
We're moving forward with this group and I'm now working on a review article with the intention to submit it for peer review and publication in a journal towards the end of the year. Continuing in the theme of publication, shortly after our Canadian opinion leader event and subsequent to quarter end in October, the first clinical paper from our clinical excellence group was published. Professor Gila Monterrey's team in Leon published data demonstrating the correlation of the Nu.Q NET level and sepsis. There is a clear mortality signal. What does that mean? The higher patients Nu.Q NET level unfortunately the more likely they are to die. We've also seen in a longitudinal fashion that Nu.Q NET level tracks very well with the severity of the patient's illness.
We've been using something called the sepsis score, the sequential organ failure assessment score to calibrate and check Nu.Q NET levels. It's brilliant that we've got the first paper out and I'm really looking forward to publishing and sharing with you more data from our centers of excellence as we go through 2024 and 2025. Over in the U.S., I'm pleased to report that Volition completed the Q sub process with the U.S. Food and Drug Administration. The FDA has confirmed that we can continue to follow a traditional 5, 10-K pathway. I'm also delighted to confirm that my own hospital guidance and Thomas has started using Nu.Q NET in our first study. In a similar theme, we're trying to identify and track patients and monitor the severity of sepsis.
This is a large study, we're aiming to enroll around 500 patients and compare patients with sepsis to healthy patients undergoing cardiac surgery. This should give us really good data to try and split the patients apart and understand differences between them. For those that might have missed the recent Edison webinar on sepsis or indeed their thematic report, I wanted to highlight a couple of ongoing studies, which we hope will continue to reinforce and strengthen our clinical utility case. We have ongoing analysis of two large retrospective sepsis cohorts in Europe. The first is with the German sepsis group and the second is with the team at UMC Amsterdam. In total, these studies will examine the outcome and trajectory of over 2,500 patients with sepsis.
They involve the processing of over 8,000 Nu.Q NET samples. It's an unbelievably rich data source for us. And we're really excited about this data. But we're really excited about presenting it and submitting it for publication by the end of 2024. These studies will be a rich source of insight using Nu.Q NET on a really large scale and should enable us to sharpen and improve it as we move forward to again bringing into the clinical arena. Our project with key opinion leader, Professor De Carli Annan [ph] in France is progressing really well. De Carl is involved in the consortium project with an ongoing prospective study of which Volition is a member. Again, it's longitude in nature and large scale and is aiming to recruit 1,500 patients. We've also extended our study with [indiscernible] in the U.S. We have refocused this study to concentrate on the sickest patients admitted from the emergency room rather than simply including intensive care patients.
This is expanding the population of patients in which we're using Nu.Q and that's really exciting. We hope to close out the study by the end of second quarter and we'll share the results as soon as we can. We're confident that we will have significantly strengthened our data within the confidential data room for ongoing commercial discussions by the middle of the year. From a publication perspective, all eyes and our focus will be on the European Society of Intensive Care meeting in October later this year. We anticipate a number of the studies I've just mentioned will report at ESICM. We're also really proud to be sponsoring our first satellite symposium session at the Congress. More details will follow, but it's going to be a really busy year ahead for Nu.Q NET and sepsis.
I'd now like to take just a few more minutes to discuss Volition's potentially breakthrough cancer detection method, which we first presented at the European Society of Medical Oncology Congress Press in 2023. Cancer, as we all know, affects the lives of millions around the world each year. Unfortunately, the number of new cases of cancer diagnosed each year is continuing to grow. Like many diseases, early diagnosis when the cancer is smaller and hasn't spread leads to a better outcome for patients that's less surgery, less chemotherapy and just needs better and improved outcomes. Sadly, cancer is often a silent disease, it's asymptomatic and people don't realize they have it until really quite late. In the UK, we're a perfect example about that, where around 45% in cancers are diagnosed at the later stages Stage 3 and Stage 4.
Our test focuses around detecting circulating tumor DNA, ctDNA. Detecting ctDNA is really difficult because the levels of DNA in blood are relatively low and circulating tumor DNA compromises only about 0.01% of the circulating cell-free DNA. While the challenge is compounded as most of the detect cancer DNA looks almost identical or is indeed exactly the same as normal DNA. Volition has developed a novel method of liquid biopsy involving the first reported physical isolation of tumor-derived DNA fragments from blood. The cancer-derived circulating tumor DNA fragments are then extracted after removal of all normal background DNA and then they are sequenced using a low-cost PCR test. We're calling this technique Capture-PCR. Volition's proof-of-concept data was presented at ESMA 2023, demonstrating the isolation of tumor-derived ctDNA fragments from plasma.
Volition tested the new method in a small clinical experiment and detected a range of liquid and solid organ cancers, including early stage disease, Stage 1 disease. These early assays were developed from our initial leukemia model, but to our surprise, we were also able to detect many other cancers. In particular, we were able to detect colorectal cancer. We're really excited about the potential for Capture-PCR going forward. My colleague, Dr. Jake Micalle and team have presented a number of cancer specific conferences such as prostate cancer and liver cancer conferences. They have been sharing their data with important key opinion leaders and we've received really valuable feedback and positive feedback as we go forward. The team have also continued to identify other potential markers and other potential targets associated with the PCR test and we very much look forward to sharing this data in particular in solid organ cancers throughout this year and beyond.
Last but certainly no means least, Jake is working hard on completing the manuscript to submit this breakthrough method for peer review publication. This is going to be incredibly important paper and is intrinsically aligned with Felicia's core ethos and purpose of bringing a low-cost diagnostic test to millions of people around the world. Understandably, there will be ongoing commercial discussions throughout the year. Enjoying to a close, and so I can hand back over to Cameron, I'd just like to take a moment and I hope it's come across from me talking here to express how personally excited I am to be joining the company. I really believe in Volition's ethos and purpose and I'll hand you back to Cameron for his closing remarks. Thank you ever so much.
Cameron Reynolds: Thanks very much, Andy, for providing those insights, and thanks as always to Terry and Tom for their reports. It is a real sign of the varied expertise we now have at Volition. 2023 was certainly transformational for Volition and a year we can look back on with pride. The commercialization of our transformational Nu.Q vet cancer test within the companion animal healthcare sector has led to agreements with several new global and regional partners, including last week with Fujifilm Vet Systems, Japan's leading veterinary diagnostic service provider and looking just around the corner, the Nu.Q vet cancer test will soon be available as an in-house diagnostic test through Heska and Antech company. We strongly suspect we will see very good revenue growth from Nu.Q vet through 2024 and beyond.
I'm also absolutely delighted in the progress made in our Nu.Q NET's pillar, and in particular, in determining our regulatory pathway forward with the U.S. FDA, a key milestone for the company and in having a number of large-scale clinical studies due for publication later this year. Thirdly, and as we always seem to run low on time, I won't cover too much, but I would like to quickly mention Nu.Q Discover, which recorded revenue of $300,000 in 2023 and now has a pipeline of projects valued at over $1 million As a reminder, Nu.Q Discover is a complete solution to profiling nucleosomes, drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their long term drug development needs. In this way, Nu.Q Discover is able to unlock value from Volition's IP portfolio by helping us commercialize the areas we are not going to focus on ourselves.
As I mentioned, revenue in 2023 was $300,000 and we expect it to more than double in 2024 and be as profitable as early as 2025. And finally, I'm absolutely also delighted with our potential breakthrough CTCF cancer detection method, Capture-PCR, which we had a poster in the Q4 at ESMO. We believe this is a true breakthrough moment. The first reported physical isolation of a class of tumor derived cell free DNA fragments from blood. We expect that this method obviates expensive and time-consuming DNA sequencing and bioinformatics, allowing for a rapid cost-effective detection in a routine blood test. This method could become a must have technology. Given its significance, we are very much open to licensing this technology. We have been tremendously encouraged by the level of interest thus far.
It has been and will continue to be a busy few months ahead of discussions and negotiations, not only now on Capture-PCR, but as we build out the data room for Nu.Q NET through the second quarter of this year, we anticipate more active discussions on that front as well. It is an exciting time for us as a Company and we look forward to sharing further updates and milestones with you over the coming quarters as we continue to adapt such changing times and conditions, deliver on what we believe to be revolutionary technologies. Given the current macroeconomic conditions, we are focusing on getting each pillar to support itself, either through product revenues, milestone payments, out licensing, or other non-dilutive funding in the coming year.
We are making every attempt to ensure as little dilution as possible to reach breakeven as a company with a mix of non-dilutive funding, revenue and milestone payments from our licensing as we have achieved in Vet. As we've described before, we are currently targeting the following. Firstly, we expect Nu.Q vet to be overall cash positive from existing milestone payments and the expected revenue ramp as more partners launch and existing partners expand into new territories. We're also working on a range of new products to drive revenue growth and hopefully new out licensing and milestone payments in future years from Vet. Secondly, we expect Nu.Q Discover to more than double revenue in 2024 and to become profitable as a unit starting in 2025, with over $1 million in the current pipeline and growing strongly.
Thirdly, we have begun the strategy to fund, as Terig alluded to earlier, our Nu.Q net pillar through non-dilutive and or project funding with an aim of $25 million. We have targeted a range of governmental agencies and are also preparing the background work aimed at attracting a large player to either out license or invest in this product directly. We have made strong progress through the first quarter of 2024 in getting the data required, and our aim is to get the first payments in the next 12 months from either corporate or governmental sources. Lastly, as discussed by Gael Forterre, our Chief Commercialization Officer in our recent webinar, there has been a lot of external interest in our CTCF and Nu.Q cancer technologies. Our strategy is to license this out to one or more large companies as a commercial undertaking of this size is likely beyond our current capabilities.
If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. In drawing to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all of our pillars. We are now happy to answer questions. Operator?
Operator: [Operator Instructions]. Our first question is from Tim Moore with EF. Tim, please proceed.
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