Immunovia AB (publ) (IMMNOV) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the Immunovia Q3 Interim Report 2022 Conference Call. I'm [ Shasa ] the Chorus Call operator. [Operator Instructions] The conference is being recorded. [Operator Instructions] The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Karin Almqvist Liwendahl. Please go ahead.

Thank you so much, and good afternoon, and welcome to this conference call following Immunovia third quarter results. Present here in our office in Lund is Philipp Mathieu, CEO; and myself, Karin Almqvist, and I'm the CFO of the company. Joining from the U.S. is Jeff Borcherding, who is the CEO of Immunovia, Inc. Before we get started, some practical aspects. This presentation will be followed by a Q&A session and our operator will guide us on how to post or guide you on how to post your questions. We do welcome questions, but for practical reasons, we ask you to limit yourselves to 2 questions at the time. After we have closed today's call, you will find the presentation and the recording on our website. And with that, I would like to hand over to our CEO, Philipp, please.

Thank you, Karin, and welcome to today's Q3 conference call. Good afternoon to those who've joined us from Sweden, and good morning to the ones who I see have joined us from press. I would like to thank you for your interest in Immunovia and our innovative pancreatic cancer test. We here are fully committed to establish ourselves as the leader in the early detection of pancreatic cancer and to save lives by doing so. I'm very excited to share with you today the progress we've made during Q3. As an agenda for today's Q3 call, I intend to cover the following topics. As I said, we are more committed than ever to build out our leadership position in pancreatic cancer testing. In this context, I would like to firstly highlight the strategic and operational focus we've adopted to achieve that. I would also like to reiterate the substantial and increasing unmet medical need and market opportunity we are pursuing. Secondly, I'm going to revisit the operational highlights during Q3. This will focus on the progress we made in our commercialization plan and the partnerships with Proteomedix, which significantly strengthens our R&D efforts. Karin will cover the Q3 financial highlights. The commercial update will be covered by Jeff, and focus on a highly encouraging interim update from our physician experience program as well as an update on our progress in executing on our reimbursement plan. We have an ambitious goal at Immunovia to use our first-to-market position with a test for the early detection of pancreatic cancer to establish ourselves as the undisputed leader in this space. With the current team and plans, I feel that we are perfectly positioned to achieve this. Our addressable market in the U.S. alone is 1.8 million individuals per year across all risk groups. We have substantiated this number during Q3 with another in-depth analysis. Currently, we are only yet [ compersion ] in the group of those with family and genetic risk factors. As such, there is a substantial upside opportunity in adding additional risk groups, which we are currently actively pursuing. Obviously, our current focus is on the successful initial launch in this first risk group. I'm very pleased with the quality and the momentum the U.S. commercial team under Jeff's leadership has developed, and I'm confident that this will translate in a dramatic sales increase during 2023. We're also highly encouraged by the feedback we have been getting from a broad set of patients and physicians as part of our physician experience program. At the same time, we are continuously optimizing our [ tactical ] commercial plan to achieve the best possible results. Reimbursement is key to make our test broadly available. I'm very satisfied with the progress the team has been making in its conversations with payers. We have a clear plan to achieve reimbursement, which is informed by numerous ongoing discussions with payers. And finally, we simplified our executive management structure to ensure quick decision-making and continued momentum in pursuing our strategic priorities as it is needed for a company in this phase. Through our long-standing U.S. marketing efforts and lately the physician experience program, we have continued feedback from physicians and patients. On a daily basis, we are reminded of the substantial and increasing unmet medical need our test is addressing. Already today, pancreatic cancer is #3 amongst the top 10 cancers by number of deaths in the U.S. This year, more than 60,000 individuals are expected to be diagnosed with pancreatic cancer. This number is increasing year-on-year, which is unique amongst all common cancers. Within the next 5 to 10 years, pancreatic cancer is expected to overtake colorectal cancer. What makes pancreatic cancer stick out are the very low chances of survival from diagnosis. At the 5-year interval, the survival rate for pancreatic cancer are by a large margin the lowest amongst all more common cancers. This is purely a statistic, but behind this number are hundreds of thousands of patients and their families, which are suffering tremendously following this diagnosis. With our test, we are the first one to launch a dedicated test for pancreatic cancer that provides an option for early diagnosis. This is not only a first, but also a game changer for patients and their families. Why is our test such a game changer? As of today, as for the National Cancer Institute, the overall survival rate for pancreatic cancer is around 11.5%, as you saw in the previous slide. Other estimates are much lower and range between 5% to 10%. What makes the huge difference is the stage at which the cancer is being diagnosed. Treatment options via therapeutics or chemotherapy have not really evolved over the past decades and lack the progress made in other cancers significantly. Partly, this is due to a lack of successes and innovation, partly this is due to a lack of investments. Surgery still remains the go-to and most promising option, if possible. Now surgery is only an option if the cancer is not metastatic yet. Unfortunately, less than 20% of patients are today diagnosed early enough for that to be the case. More than 80% do not have that option and 5-year survival rates dropped to 3%, which is dramatic for the patients and their families. Reasons for that are lack of surveillance and screening mainly for -- especially at-risk individuals but predominantly the shortcomings of current diagnostic methods, which failed to deliver early enough diagnosis. Our mission now is to allow more patients to benefit from surgery as the treatment options and have a 5-year survival of rate not 3%, but more than 40% for more patients. That is where our test makes the difference. Moving that less than 20% of people through a significantly higher number, which will drastically improve over survival rates. That's where we make the difference and that's where our unique test comes in. Turning over to the addressable market that we see given this large unmet medical need. Most of you are familiar with the total addressable patient population of 1.8 million in the U.S. per year, which we've highlighted previously. As I said earlier in this presentation, we have, during Q3, conducted another more refined analysis of the total addressable market for our test. This analysis, which was conducted with input from outside consultants and clinicians underscored the previously communicated 1.8 million individuals per year. These are 1.8 million individuals, which would be targeted by our tests. As you know, today, we are only commercial in the risk group of individuals with a family or genetic risk structure here highlighted in green. New onset diabetes remains the largest opportunity. In this risk group, we are conducting our PanDIA clinical program. The other risk groups include pancreatitis and IPMN, i.e., cysts of the pancreas. For all those risk groups, we are either conducting or developing further clinical plans. Lastly, there is a differential diagnosis bucket, which is not included in the 1.8 million patients. This is a bucket which we are still analyzing, which could provide additional upside. What is common among all of those risk groups is that these are existing or future surveillance markets, which allow for highly targeted sales approach. Already today, there are established surveillance routines and programs for individuals with family and genetic risk factors for pancreatic cancer as well as for chronic pancreatitis and pancreatic cyst. This allows us to not only be targeted, but also use synergies since these surveillance programs are either conducted at high-risk surveillance centers, many of which we know and have access to or gastroenterologists. Early today, we target both of those groups. In summary, we see a vast unexplored market opportunity for Immunovia, which will more than triple our initial market. Now what is the operational progress we made during Q3? Our operational highlights in Q3 were focused on commercial and delivered on our previously communicated targets. Firstly, the PLA code, which was approved, became effective on the 1st of October. We also extended the availability of our test to now include California. This is a highly attractive market for us, and our sales and marketing teams are already actively pursuing this opportunity. And we received the preliminary payment dissemination from the Centers of Medicare & Medicaid Services which we're very pleased with. This determination implied a rate of $897, which, in our view, properly values our innovative test and followed our recommendation to CMS. We expect the final determination during the course of this month. I will let Jeff later shed a bit more light on the significance of those milestones. Shortly after Q3, we announced our strategic R&D partnership with Proteomedix. Our companies have been working together on a project basis since Q2. We now took this partnership to the next [ level ] in entering into it and fully benefit from our combined expertise. This partnership commands the R&D skills and efforts of 2 leading innovators in Proteomedix-based cancer diagnostics. Both companies have a proven track record of successfully developing and launching novel tests in this space. In the case of Proteomedix, the Proclarix, a prostate cancer test that is currently marketed in Europe as a [indiscernible] test. And in our case, as you know, with IMMray PanCan-d marketed in the U.S. as the first dedicated pancreatic cancer test. With this partnership, we intend to increase the momentum of our R&D efforts in pursuing the previously discussed markets. We see key benefits of this collaboration and increased R&D productivity and efficiency and creating a more flexible R&D organization as it is needed for a commercial company and being able to focus our internal resources on the commercial buildup and the rollout of our tests in the U.S. We at Immunovia are very excited to work with the Proteomedix team going forward and together advance our R&D efforts. With that, I'm handing over to Karin to cover the Q3 financial highlights.

And thank you for that. Being where we are, building the company commercially, revenues, as you can see, have not yet materialized in a meaningful way. Thereby, it's important to understand where we are on that journey when evaluating us financially. We are still a cash burning company and we burn approximately SEK 15 million to SEK 20 million per month. With this, key for us is to ensure that we spend and -- what we spend and how we invest is where we see the best return for the future. Looking at the third quarter or looking at our numbers year-to-date, we are, when it comes to operating expenses, at relatively stable levels. There will always be some seasonality or timing differences between quarters, and we will also, going forward, see a gradual shift from R&D to commercial-focused spend. Comparing quarter-to-quarter or year-over-year, there are 2 items that are having a material impact. One is currency exchange effects that for us are material based on the strong U.S. dollar; and the other one relates to the fact that we capitalized R&D in 2021. But as said before, underlying performance is stable. And in September, we've had cash at hand just shy of SEK 160 million, which puts us in a solid position to cater for our needs into next year. And with that said, I hand over to Jeff.

Thanks, Karin. I'm very excited to share an update on our physician experience program. As you recall, we are running a program to provide early access to our tests to pioneers in early detection, where we give clinicians at high-risk surveillance centers access to no-charge tests and enable them to be comfortable with using IMMray PanCan-d in their clinic and include that in their standard surveillance routines. And as we do that, we're looking to drive familiarity with the test, to drive commercial adoption of the test and also to build advocates among those clinicians who are using the test. And I'm very, very encouraged by the results that we've seen so far. We've got over 20 high-risk surveillance centers that are participating in this program. And you can see here that we've collected imaging results for over 85% of the program participants tested to date. What that means is that we now have, for all of those patients, not only the IMMray PanCan-d results, but the corresponding imaging results. That is part of our clinical program to demonstrate the utility of the IMMray PanCan-d. As you think about that goal of developing advocates, one of the things I'm excited to share is that we've already had 3 different clinicians who are participants in the Pioneer's program who have joined us in conversations with commercial payers in seeking reimbursement for IMMray PanCan-d. And we expect that to continue and expand as we continue to talk to other payers across the spectrum. One of the other things that this program has led to is opportunities for research collaborations. Two of the sites that are involved in the Pioneer's early access program have proposed additional research where they have ongoing research projects that are funded by grants from other entities where they would like to incorporate the IMMray PanCan-d test, and we're able to do that and generate additional clinical data at very little incremental cost to Immunovia. In short, we're very excited about the physician experience program that will wrap up in the fourth quarter, and we will then transition into sort of a traditional post early access program. But so far, that program is very, very much achieving our goals. If you go to the next slide, one of the things that we've done is surveyed clinicians to understand how they're using the test, what's their response been to the test? And you can see on this slide that physicians have really shown a high level of appreciation for the usefulness of the IMMray PanCan-d test. We asked them how helpful do they find the test in managing their high-risk patients? We ask clinicians that question on a 5-point scale. And you can see here that 33% said very helpful or a 5 out of 5 on that 5-point scale, 56% said helpful. So in total, 89% or almost 90% are saying that it is helpful in helping them manage their high-risk patients. And you can see on the slide here some of the very positive qualitative statements that we've heard from clinicians. And this has been consistent with what we've heard from clinicians outside of the survey as well. As part of this survey, if you go to the next slide, one of the things that we've also done is ask clinicians to tell us how are their patients responded to IMMray PanCan-d. And what you can see here is that patients have been very, very receptive to being tested with IMMray PanCan-d. On that same 5-point scale that we talked about previously, all of the physicians said that their patients have been either very interested or interested in getting IMMray PanCan-d, and that's consistent with feedback that we've heard from clinicians throughout the country where they are telling us that when they bring up the IMMray PanCan-d test, when they talk with patients about the idea of a simple blood test to help them with their surveillance efforts, to help them detect pancreatic cancer early, the response from patients is very positive. And you can see, in addition to patients being receptive to that, we've also gotten very high marks from physicians when they talk about the satisfaction of patients after they get the testing. So these results are results that come from surveys that we've done with physicians where we're asking them about the patient response. I'm also very excited to see the results of research that we have in the field currently where we're reaching out directly to patients to get their input on the IMMray PanCan-d test, how they see that fitting into their efforts to make sure that they don't get pancreatic cancer at too late stage to make an impact, as Philipp talked about earlier. And we continue to believe that driving that patient interest in IMMray PanCan-d is going to be a crucial part of our commercialization strategy and a crucial way that we can drive volume in 2023 and beyond. If we go to the next slide, we've talked about the physician adoption and use of the test. As Philipp mentioned, our other key focus is -- in the U.S. is building the case for reimbursement among U.S. payers. You can see here a number of the accomplishments that we've had over the last 18 months. We are very excited about a number of the things on this list, including the fact that we now have a PLA code approved, that PLA code will enable physicians to code the test and enable us to submit claims to payers. It's an important operational step in getting reimbursement. In addition, we have been working on securing a rate on the clinical lab fee schedule with the Centers for Medicare & Medicaid Services, the primary government payer in the U.S. The way that, that system works is that CMS will publish a clinical lab fee schedule that includes the rates that the government will pay for all test like ours. There is a pretty extensive process that we go through in order to have the rate determined for that fee schedule. We are near the end of that process, and I'm very pleased with the way that it has gone. We recommended to CMS that our tests be priced at a similar level to a technically similar test called OVA1. That test is currently reimbursed by the government at a rate of USD 897, and so that would imply that we would be reimbursed at a very similar rate once we're able to secure reimbursement. That determination is preliminary. We're currently in an open comment period where members of the public and clinicians and payers can provide feedback on the various rates that have been proposed by CMS, but that process will complete here in the fourth quarter, and we should have a rate on the clinical lab fee schedule by January 1, 2023. What that means at that point is that we will know the price at which we would be reimbursed by the government, once we have their agreement to pay for the test. That agreement to pay for the test comes with their determination that the test is medically necessary, and that determination is based on the clinical evidence that we share with them. We do have to go through the process of submitting that clinical evidence and going through their review process. So it will take some time for us to see that government reimbursement, but it is, nonetheless, a very important milestone and a very positive development for the company because it sets the rate for reimbursement for Immunovia at a level that we feel is very favorable and fairly represents the value of the test to patients and to clinicians. Also wanted to highlight on here the fact that we are in discussions with handful of payers to do early programs that they call coverage with evidence development. Essentially, what that means is that the payer will work with us to generate additional clinical data to support the use of IMMray PanCan-d, and while they are doing that, they will reimburse us for the cost of the test. So these are tremendous opportunities for us to get the initial reimbursement for IMMray PanCan-d, but also to generate additional clinical evidence that we can submit to both that payer as well as other payers in our efforts to secure positive medical policy and to secure their agreement to reimburse us for the test. In parallel with those discussions with payers around coverage with evidence development programs, we continue to pursue our clinical programs to build the clinical evidence, to show that IMMray PanCan-d not only makes an impact on patient outcomes, but in addition, is a cost-effective tool for payers to implement. That clinical evidence will come from a few different sources. I mentioned earlier, our Pioneers program will enable us to generate clinical data that we hope to publish in 2023. In addition, we have a number of collaborations with investigators in the U.S. who we are collaborating with on research. And then as I mentioned, the payers who are doing coverage with evidence development programs with us would hope that we can publish those results as well so that we can use them more broadly in our reimbursement efforts. So we continue to be very focused on generating that clinical evidence that will convince payers to reimburse the IMMray PanCan-d test. We really need to show them 2 different things. One is that there is a decision impact in using the test; and second, that using the test improves patient outcomes. The Pioneers data should be helpful in both contexts, and we'll have additional studies that will address the improved patient outcomes. And with that, I'll hand it back over to Philipp to conclude the presentation.

Thank you very much, Jeff. So in summary, 2022 to date has been a year of significant progress for the company and establishing ourselves as the leader in the early detection of pancreatic cancer. Very importantly, we delivered on previously communicated milestones in all areas. Operationally, we sharpened the focus of the company to only target pancreatic cancer. We significantly strengthened our U.S. commercial team, which is now best placed to further increase momentum in growing adoptions and sales of our tests. And we entered into the R&D alliance with Proteomedix which ensures increased R&D momentum. Driving adoption and reimbursement, we made significant progress. Firstly, in deepening our strategic partnerships with key stakeholders in the field, also in launching the physician experience program Jeff talked about, the first of its kind. We also brought on board a head of U.S. market access to accelerate and lead our efforts with payers, and we took various significant regulatory and commercial steps in the launch of our tests. We also made progress on the clinical side to expand the set of applications supporting our tests and pursuing an additional risk groups in new onset diabetes. Now looking forward in the current quarter and 2023, I'm very confident that we will harvest the fruits of these efforts, which will materialize in, firstly, a dramatic sales increase; secondly, a higher adoption of our test through increased awareness; and thirdly, in successes with payers in executing our reimbursement plan. With that, I conclude the presentation, and I'm very happy to lead over into the Q&A section of this presentation, inviting for questions.

[Operator Instructions] There are no questions at this time.

So operator, if there are no further questions -- or have you received any so far?

No, sorry, there are no questions at this time.

Then I suggest that we round up and close the call for today. So I hand over to you to do that, please.

Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.