Ladies and gentlemen, welcome to the Immunovia Q1 Interim Report 2023 conference call. I am Sandra, the Chorus Call operator. I would like to remind you that all participants have been listen-only mode and the conference is being recorded.
The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Karin Almqvist, CFO. Please go ahead, madam.
Thank you so much. Good morning and good afternoon to you all. Welcome to this conference call following Immunovia's first 1/4 results 2023. Present here in our office in Lund is Jeff Borcherding, CEO, and myself, Karin Almqvist Liwendahl, CFO of the company. Before we get started, we have, as usual, some practical aspects.
The presentation, as already announced, will be followed by a Q&A session. The operator will guide us on how to pose questions. In addition to that, last or not least, we do welcome questions after our presentation. Having closed the call today, you will find presentation and the recording on our website. Having said that, I'd like to hand over to Jeff. Please.
Thank you, Karin. I'm very pleased to be with you today for my first call as Immunovia CEO. During our time today, I'll highlight key developments in the first 1/4 of 2023. I'll also share a review of our challenges with the goal to be more transparent about the road ahead.
I'll outline our plan to meet and overcome these challenges to build revenue and make Immunovia the company we all want it to be. I'm honored to become the global CEO of Immunovia. In addition to passion for our mission, I bring a range of experiences to the role that will be very helpful as we achieve that mission. For the last year, I've been the CEO of the U.S. organization of Immunovia.
In that role, I've been leading the commercial introduction IMMray PanCan-d and also building the commercial team and the leadership team in the U.S. to deliver on the promise of our test. I have extensive background in diagnostics, most recently with Myriad Genetics, 1 of the largest and most successful diagnostics companies in the United States, where I was chief marketing officer before joining Immunovia.
Prior to that, I led the commercialization and later served as the general manager for the GeneSight business at Assurex Health and at Myriad after the company acquired Assurex. GeneSight is recognized as 1 of the fastest-growing products in the history of U.S. diagnostics, and I learned quite a bit in that role that I'll apply to the situation here. Those experiences built on the skills that I developed as a brand manager at P&G Pharmaceuticals.
During most of my eight years at P&G, I worked in the gastroenterology space where I led the Asacol business, which at the time was the leading treatment for inflammatory bowel disease. Leading that business gave me a deep understanding of gastroenterology and connections that I'm able to leverage today in the space. I mentioned the passion that I have for our mission, that mission is simple:
To advance early detection of pancreatic cancer and increase patient survival rates. We have a tremendous opportunity to save the lives of individuals who are at risk for pancreas cancer. This next chart illustrates why. It also shows why our mission is so important and why the opportunity is so great. More than 80% of the time, pancreatic cancer is diagnosed at late stages when the patient has already begun to show symptoms. Unfortunately, by then, it's too late.
Surgical removal of the cancer is not an option. These patients have a horrible prognosis. Their 5-year survival rate is just 3%. If physicians can find pancreatic cancer early, the survival rate is about 10 times higher. The IMMray PanCan-d test does just that. Clinical data shows that we can detect pancreatic cancer at stage 1 and stage 2 with high accuracy.
That really forms the basis for the opportunity ahead of us. I'd like to talk with you a little bit about what we've achieved in Q1, talk about some highlights. I'll also ask Karin to share some financial results before we talk about the challenges that we face going forward. Since we launched IMMray PanCan-d test, we've really been focused on driving adoption among clinicians who lead high-risk pancreatic cancer surveillance centers.
These are programs that are usually at academic centers in the United States that are dedicated to providing pancreatic cancer surveillance for people who are at high risk. That might be people who have a family history of pancreatic cancer. Maybe they have genetic mutations that put them at risk. There are other factors.
At the end of the day, that risk makes them appropriate for surveillance. There are more than 200 of these centers across the country. Today, we reach a portion of them with the sales team that we have, which is targeted in certain geographies because of the fact that currently, we're limiting the size of that team while we refine our go-to-market model. To date, 34 centers have utilized the IMMray PanCan-d test. On the right side of the Slide, you can see some of those centers.
It's a mix of leading academic institutions as well as very large regional health systems. If you joined us for the commercial adoption podcast, or I'm sorry, A couple weeks ago, you heard from clinicians at Hackensack Meridian, as well as University of Colorado.
These are just some of the institutions that have begun using the test on a very regular basis. 21 centers have ordered 5 or more tests, and that number will grow dramatically as time goes on. Because this group has been where we focused initially, about 83% of our test volume in 2022 came from high-risk surveillance centers. That number decreased slightly in 2023 as we grew our prescribing base outside of these centers, but they're still critically important.
1 thing that's really important is that some of these centers have begun to include IMMray PanCan-d test in their standard surveillance protocol. Moving from using the test on a trial basis or using the test in certain situations to incorporating it into the standard practice for each patient who's in surveillance with that center is a key goal of our sales team. The expansion of the market for early detection is also really important.
While the high-risk surveillance centers have been our focus initially, the reality is that for us to achieve our mission and to achieve our financial goals, we're gonna have to expand beyond just those high-risk surveillance centers. Today, only about 1 in 5 people who's at high risk for pancreatic cancer is in 1 of those surveillance programs.
As a result of that, we've got to get out to the gastroenterologists that are in the community, convince them to take responsibility for identifying and monitoring high-risk individuals that come to their clinics every day. What we know is that those clinicians are reluctant to take on pancreatic cancer surveillance. In some cases, it's just not top of mind.
They have other things and other priorities clinically that they're focused on. 1 of the other things that we hear is that they don't really have the ability to do pancreatic cancer surveillance in the way that it's been done historically, according to the standard of care, which today is all based around imaging. That might result in the patient having an MRI or having an endoscopic ultrasound. These are advanced procedures. Many gastroenterologists don't have the expertise or the equipment to do them.
Giving them a simple blood-based test like IMMray Pancan-d really enables them, for the first time, to get their patients into a more organized pancreas cancer surveillance program. Currently, this group of clinicians, these gastroenterologists that are in the community, are a small portion of our test volume, but it's growing fast, and the number of ordering clinicians is growing dramatically.
Currently, this is a situation where we've got a small number of high-risk surveillance centers with a large number of orders. We're also building a business that is much broader based, a lot more clinicians among the community gastroenterologists, and the next step is really to build the volume for each of those clinicians. Today we've had 124 clinicians who have ordered the IMMRayPANcanD test, and 4 out of 5 of them are practicing outside of those high-risk surveillance centers.
Even though that was our initial focus, and it continues to be a big part of what we do, we have made good progress in penetrating these community gastroenterology practices. 1 example of such practice is Dr. Gilberto Simoni, who is in California and leads a practice called Advanced GI.
Through conversations with 1 of our sales representatives, he recognized that there was a large gap in his efforts to take care of his patients and make sure that they were not developing cancer.
He's now IMMray PanCan-d test at 2 different clinics where he practices, and he's ordering tests on a weekly basis. This is just 1 case study, but it's an example of what we're trying to build and some of the progress that we've made in the first 1/4.
As we make progress on driving adoption and use of IMMray PanCan-d test, it's also critical that we make progress on reimbursement. This 1/4, we met with nine commercial payers, which is a large number given the significant access challenges in the US payer market. We are a small company, and so we must be creative and find ways to get in front of these key decision makers. When we meet with them, we've done a couple things over the last 1/4.
1 is to lay out the clinical need for an expansion of pancreas cancer surveillance. We've helped them understand the gap in their current membership for pancreas cancer surveillance. We've also given them a financial model that really allows them to forecast the financial impact of doing a better job of implementing pancreas cancer surveillance using our tests.
These tools have led to productive discussions about IMMray. They open up the opportunity for us to get deeper into conversations about our clinical data and about future coverage of the test. Those have been some of the highlights around physician adoption as well as our payer efforts. I'd like to hand it over to Karin to talk through our financial highlights from Q1.
Thank you. And as we can hear from Jeff, it's all about reaching out and driving adaptation of our test. Thereby, we should also have modest expectations when it comes to revenue levels, looking into 2023. From a financial perspective, focus is on cash.
With the SEK 68 million we had in cash end Q1 and the SEK 122 million we got in proceeds from the rights issue, we are able to fund our operations into 2024. To ensure this, we are continuously monitoring and keeping a tight control of our costs. I have in earlier calls made the comment that we should see a gradual transition from having relatively more being spent on the R&D side over to, or shifting over to the commercial side. This transition, we can see it start to be visible.
Cash burn for the company, cash burn for the 1/4, I should say, was SEK 40 million. Previously, we have given the guidance to the market that we have a cash burn rate between SEK 15 million-SEK 20 million. We are currently trending towards the lower range of that. With that, back to you, Jeff.
Thanks. Now I'd like to share the challenges that we face, or at least some of the key challenges, and how we plan to overcome them. 1 of the top challenges is the demands from payers in the United States for clinical data before they are willing to provide reimbursement for our tests. These pay requirements really are broad-based, but there are 2 key things that I want to focus on today.
1 is the clinical data showing the accuracy of our tests. That's also called clinical validity and refers to the sensitivity and specificity of the test to detect pancreatic cancer. The second element that they look at is clinical utility, and that essentially means can we demonstrate that patients do better, they have better health outcomes when you use the MRay PanCan-D test.
Many of these payers require 2 studies of both accuracy or clinical validity as well as clinical utility. You may recall we talked previously about our PanFAM-1 study. That study was intended to meet this need. Unfortunately, we had too few cancers in that study to assess clinical validity or clinical utility. As a result of that, we've got a clinical data package that we need to expand and enhance to meet the requirements of government as well as commercial or private payers.
As we've met with payers over the last few months, we've gotten a better understanding of what their requirements are and are thinking about how we meet those requirements with ongoing clinical studies. Which brings me to 1 of our other challenges, which is proving clinical utility in pancreatic cancer. Pancreatic cancer is incredibly deadly. It's also less prevalent than many other cancers.
If you want to show clinical utility in a study, you generally need a very large number of patients, and you have to follow them for a long period of time. We saw the challenges of doing this with the PanFAM study, meeting this challenge requires creativity.
I'm going to talk in just a moment about how we plan to do that, how we plan to achieve that clinically, but also how we plan to achieve that financially in a way that makes sense. That brings me to the third challenge, which is the current financial climate. We know that financial markets right now are taking a risk-averse posture, as a result of that, for companies like ours that are not yet profitable, there is limited access to capital.
That financial climate is leading us to look for creative ways to find funding as well as Karin highlighted, thinking about ways that we can make sure that we operate in a very lean way and keep our burn rate as low as possible on a monthly basis.
Here is a quick summary of the key elements of our plan for 2023. We want to partner with existing clinical studies and biobanks to deliver the scale required to demonstrate clinical utility. We're pursuing a 2-pronged approach to securing reimbursement, and I'll share more about that as well as each of these elements of the plan in just a moment. We're going to continue to manage costs in a disciplined way, and we will pursue funding as we need it.
Finally, we'll continue to drive clinician and patient adoption of the IMMray PanCan-D test in targeted, cost-efficient ways. As we think about this idea of partnering with existing clinical studies and biobanks to deliver the scale required to demonstrate clinical utility, this is really about partnership.
Partnering with groups that are conducting studies or that have existing data that we can leverage in order to demonstrate clinical validity and clinical utility in a much more cost-effective way and in a way that's much faster than starting a dedicated study on our own.
There are 3 different types of opportunities here. The first is working with 1 or more of the research consortia that are out there. These are groups of multiple centers that are conducting joint clinical studies.
1 example of this is the PRECEDE Consortium that is recruiting thousands of patients for a study in pancreatic cancer surveillance. Those kinds of consortia give us a number of advantages. They're very large.
They can recruit much more quickly. They are multi-center, there's a level of rigor that comes along with these studies that's very attractive to payers. Participating in 1 of these consortia also allows us to get the benefits of a large study without having to bear all of those costs ourselves.
1 of the other options is to work with large biobanks. These are centers that have blood samples as well as other clinical data about patients that they've treated historically. We can use that stored clinical data as well as that stored blood to run the IMMray PanCan-D test and to assess our clinical validity and our clinical utility.
1 of the things that's very attractive about these is that we can do studies retroactively or retrospectively, meaning that we don't have to start the study today and recruit the patients. We already have the data. It's a matter of running our tests after we acquire the samples and then analyzing the data. This allows us to move faster and often reduce our costs.
1 of the other opportunities, from a limited number of biobanks, there are a very small number of them that may enable us to do longitudinal studies where we can look at the effect of the test over time, and we're very excited about those. Finally, there are a number of large health systems in the United States. These are sometimes academic centers.
They're sometimes regional health centers that have hospitals and clinics throughout several states. These systems sometimes run large studies. We know of at least a few in pancreas cancer. We're in conversations with those health systems now. These allow us to capture individuals that are at risk for a wide range of reasons.
Because these patients are being treated by these health systems, they have a wealth of data about them. So we're not just limited to 1 individual risk group, like, say, for example, those who have family history of pancreas cancer.
We can get decent sample sizes with these studies. Because they are done within 1 system, you often have a high level of control, which is usually helpful for making sure that we have clear and clean results at the end of the studies.
A number of good options here that, in summary, allow us to generate the clinical data that we need to support our payer efforts to secure reimbursement, to do that more quickly, and to do it at a lower cost. Switching now to reimbursement, we want to pursue a 2-path approach to securing reimbursement.
I've talked about the fact that we do have challenges with our current clinical data package. In order to secure medical policy with most traditional commercial payers and with Medicare, we're going to need more clinical data, and as we just discussed, even though we have good options to do that, it will take time. As a result, 1 of the things that we're looking at in parallel is working with some of the innovative commercial payers that exist in the US.
These are payers that have programs where they will allow you to pilot the use of your test in their membership. These pilots are sometimes paid, they are sometimes unpaid, they always give us the opportunity to generate additional clinical data.
We're very excited about these opportunities to work with payers who have a desire to do something innovative like in IMMray PanCan-D. There's an opportunity to generate revenue in the near term and over time to generate some additional supportive clinical data.
If you think about timing and how these different strategies pay off, in 2023 and to some extent into 2024 will be opportunities for these pilots with the innovative commercial payers. The bulk of the payers will likely come in 2025 and beyond as we begin to get results back and publish results from the clinical studies that we talked about on the prior Slide.
As we do these efforts, we need to make sure that we manage costs in a disciplined way. How do we do that? Well, we're going to focus our spending on the things that are most important and most critical for driving our success. That's the clinical studies to support reimbursement decisions, targeted selling efforts. I mentioned earlier we have a small agile sales team today.
I suspect for the rest of 2023, we will continue to have a relatively small sales team. We'll use that team to confirm that we have the right selling model, we have the right targeting, we have the right messaging, we have the right and optimal tactical plan so that we can then, as needed, raise additional funds with the knowledge that when we have additional support financially to support expansion, we've got a model that we know can generate volume.
Beyond talking with clinicians, we also see a huge opportunity for digital and consumer marketing. 1 of the things that we've seen since we launched the IMMray PanCan-d test is that there is a really high level of consumer interest in a blood-based test to screen for pancreatic cancer.
The reality today is that patients who are in these surveillance programs are subjected to endoscopic ultrasounds, which is an invasive procedure. It requires anesthesia, generally have to go to a hospital for that diagnostic workup to be done.
You can also have an MRI. For many people, that causes additional problems of claustrophobia and anxiety of being in an MRI machine. There is an opportunity to reach out to consumers directly who have concerns about their risk for pancreas cancer and get them to go into their physician and ask for the test. We'll be working on that as we go throughout 2023.
As we think about our spending priorities, we do wanna make sure that we've got an eye on the future and that we are continuing to do research and development so that we can develop tests for additional risk groups.
We will be looking at our existing PanCan-D tests, as well as some additional biomarkers to see what's the optimal approach for new groups like new onset diabetes. As we look at our financial future, we know that we have the financial means to support our operations into 2024, but at the same time, we realize that we have to be thinking about funding. We have to be thinking about cash and resources. We'll look for creative ways to fund the business.
1 example of that is that we are currently looking at multiple opportunities to apply for research grants. In the US, there are opportunities for grants where you can partner with academic institutions as a commercial company and rely on government funds to partially or fully support research studies. We are pursuing some of those avenues as well as, you know, we'll consider more traditional sources of funding as needed.
Finally, the last leg of our 2023 plan is the focus on driving clinician and patient adoption of the IMMray test in targeted cost-efficient ways. We talked earlier about our dual focus on high-risk surveillance centers, as well as expanding the market by going beyond those centers to grow the market for pancreas cancer surveillance.
If you think about what we're doing in the high-risk surveillance centers, we'll continue to do what's working. We'll leverage the clinical evidence we have. We'll continue to build on research partnerships that have been very productive. We've used the physician experience program, Pioneers in Early
Detection, to gain traction in some of these centers. Most importantly, the high-performance sales representatives that we have are the key driver of our adoption here. As you think about expanding the market for pancreas cancer, I mentioned earlier that we have a focus on those gastroenterologists who are in the community. Fortunately for us, there is a subset of gastroenterologists, there are about 3,000 of them nationally in the U.S., that focus on pancreas-related diseases.
This is a highly targeted group that we can go after to convince them of the importance of pancreatic cancer screening and using the MRA PanCan-D test. 1 of the other opportunities is a group called genetic counselors. These are people who have extensive training in genetic mutations and the risks that they pose for the people who have them.
They're often the front lines in providing counseling for patients who have learned that they have different genetic mutations that they've inherited from their family that put them at risk for pancreatic or other cancers. We can tap into this group because they're highly motivated to give solutions and guidance to the patients who come to them, usually with quite a bit of anxiety because of the genetic mutations that they have.
As we think about expanding the market, I mentioned the importance of effective digital and consumer marketing, and we'll also be leveraging some of the advocacy organization partnerships that we have. In closing, I just wanted to talk about some of the key upcoming milestones as we pursue the 4 elements of our plan and work to overcome the challenges that we spoke about.
You know, we believe that we will see initial commercial reimbursement through coverage with evidence development pilots in the second 1/2 of 2023. We also expect to announce specific study collaborations. I mentioned the different types of things that we can do earlier. We expect that in the second 1/2 of this year, we will announce several study collaborations.
Finally, we'll be tracking adoption, sales, and marketing milestones as we look at the number of clinicians who are ordering MRA PanCan-D for the first time, the number that are adopting it, meaning they've used it 5 or more times. We'll also be working on implementing a robust annual testing process. 1 of the real opportunities that we have financially as a company is that our test is not a one-time test.
Once someone has the test, there's an opportunity to create an annuity of future volume and revenue as that patient comes back on an annual basis to get more MRA tests. 1 of the things that we've learned in talking with gastroenterologists and talking with high-risk surveillance centers is that they often lack the capacity to make sure that patients are coming back regularly and complying with their surveillance program.
We are putting the systems in place so that we can be the driver of those reminders. We can remind clinicians and make it incredibly easy and streamlined for them to reorder the next IMMray PanCan-d test for that patient. We can also reach out directly to the patient to make sure that he or she is getting that next MRA test.
We think that creates a tremendous volume and ultimately revenue opportunity for us in coming years. Finally, as we think about how do we convert the consumer interest that we're going to generate for the test into volume, 1 of the things that we'll be working on, and we expect to implement in the first 1/4 of 2024 is a telehealth evaluation and test ordering service via PWN.
PWN is a group of clinicians that provide telehealth services, and 1 of the things that they do is evaluate whether certain tests, like the IMMray PanCan-d test, are appropriate for specific patients. In closing, we have a number of challenges ahead of us. We are gaining momentum. I'm incredibly excited about the future.
We have an incredible opportunity ahead of us to build a big business behind the early detection of pancreatic cancer and in the process, make a dramatic impact on the lives of people who, without a test like MRay, can lose their lives to pancreatic cancer because we just don't find them soon enough. It's been a pleasure to share our Q1 results with you, and we'd love to answer some of your questions.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on the touchtone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands until asking a question.
Anyone with a question may press star and 1 at this time. Once again, to ask a question, please press star and 1. The first question come from Abraham Denius from... He's a private investor. Please go ahead.
Hi. I was wondering about the reimbursement. When can we expect for it to be completely done, the reimbursement? Can we expect it to be done this year or?
Just to clarify, when you say completely done, I'm assuming that you mean that we would have full coverage across all payers in the U.S.?
Yeah. I mean, well, at least 1 of the insurance companies.
Okay. Yeah. Yeah. My expectation is that we will secure reimbursement from our first commercial payer this year. I think in terms of how long it takes to get to the full market being or the full market reimbursing for the IMMray PanCan-d test, history would show that that is something that takes years, and I would expect that that would be the case for us. We do expect that we will see our first commercial reimbursement this year based on some discussions that we're in right now.
Okay. What happens after the reimbursement? Can we expect the sales to increase a lot in order to for the company to stay on its track and not risk anything?
Yeah. I think once we see reimbursement, the financial impact of that will depend on the specific payer that we work with. It would be a little bit speculative to say what the revenue impact will be. I suspect that the primary revenue impact will be beyond 2023. I do think we will see initial reimbursement revenue in 2023, but that revenue is likely to be modest in 2023.
Okay. Going to 2024 then, can we expect the reimbursement to increase a lot in order to for the cash to hold up in the company? Do you need to fill up the cash position that next year? What's your take on this?
Yeah, that's a good question. I would be reluctant to speculate on what our reimbursement specifically looks like in 2024. I do think if you look at the history of diagnostic businesses, it takes longer than many would like before you reach a cash flow positive position where you don't need external funding. We will be mindful of both managing our spending and then also looking for opportunities to secure financing as appropriate.
Okay. Because I'm asking because the share price has fallen a lot, I think it's critical to not, well, ask the shareholders for more money right now, at least, if you know what I mean.
Yeah. I certainly understand and appreciate the challenges of being an Immunovia shareholder over the last several months. Please know that, I understand how difficult it's been, and we are very focused on turning that around.
Yeah. I assume. What can we expect in order to turn this around for the shareholders, at least, because the share has fallen a lot today, and well, it can feel a little bit hopeless right now.
Yeah, I certainly wouldn't want you to feel hopeless. Yeah. I certainly wouldn't want you to feel hopeless. I think, my hope is that with the CEO letter and with this presentation, we've laid out, you know, a plan that gives you some clarity around the things that we'll be doing in 2023 and in 2024 to address those challenges.
While we certainly don't have a crystal ball, I'm optimistic about the future and excited about the opportunities that we have ahead. There is a tremendous clinical need for this test. While we have challenges in driving broad-based adoption and reimbursement in order to become a profitable business, I'm confident that we'll work through those challenges.
Yeah. Thank you so much. That's all my questions.
Thank you very much. Thank you.
For any further question, please press star followed by 1. Far, there are no more questions from the phone. Would you like to conclude the conference call, sir, with some closing remarks?
Yes. I just would like to close by saying that I'm honored to be the CEO of Immunovia. I know it's been a challenging time, and we are very focused on what we need to do in order to make this a successful business and in order to achieve our mission.
Look forward to keeping you up to date with things that are happening as we go through the next couple of 1/4s and into 2024. I do believe that we will have good news to share and look forward to future conversations. Thanks very much for your time.