Verici Dx drives commercial growth, capturing US transplant market (LON:VRCI)

Verici Dx

Verici DX plc (LON:VRCI) Chief Executive Officer Sara Barrington caught up with DirectorsTalk to discuss their RNA-based transplant diagnostics platform, commercial milestones, reimbursement progress, and the accelerating rollout of its flagship test, Tutivia.

Q1: As this is our first conversation, could you just give us a quick overview of Verici Dx and your main focus right now?

A1: The company is a diagnostics company that’s primarily focused on the US at the current time, although we would have a future globally. We specialise in transplant tests, and we use both lab techniques and biology with AI development and ongoing management techniques to pull out the answers.

We talk about the tests being RNA signatures, RNA being kind of like the messaging of the body and that’s all of the messaging. So, what we do is we use lab techniques called sequencing, and we take out all of the messages from a blood sample and then we apply a clinical question through AI techniques. Now, these are deep mathematical models, not language models that we’re all talking about these days, these are more old-fashioned deep learning mathematical-based models to pull out the answers to those clinical questions. That gives us the genes of choice. Once we’ve developed that and we’ve gone through validation to prove that that’s in fact the case, that’s the signature that we use for our test.

We’ve chosen kidney transplant to start off with to prove this approach, and we looked at the end-to-end journey of a patient. So pre-transplant, we asked the clinical question, how aggressive or benign is the immune system likely to be when that patient has a transplanted organ? Of course, the immune system is normally our best friend. For transplants, it sees the transplanted organ as an enemy thing, something to attack until it gets embedded. So, that’s a very important question for clinicians, knowing what they’re facing post-surgery. That was completely novel and was developed and licensed out to Thermo Fisher.

The next test that’s along that patient journey is post-transplant, that’s our flagship product, that’s called Tutivia and we directly sell that one. That answered the clinical question: how likely is it that the patient is experiencing a rejection event that the clinician needs to intervene in? Sometimes that’s not always the case. The body is dealing with it, but this has both immune system pathways and metabolism and repair pathways included into that answer. That’s the test that we sell.

Long term, we said, what’s the clinical question for long-term outcomes? That’s normally around fibrosis mechanisms, etc, those are the kind of long-term challenges for patients. That’s currently still in development, it’s going through validation and we expect something to come out by the end of the year.

So, that’s our three tests that we develop. We also have a urine programme behind that so that’s based on proteins rather than RNA. Again, a very similar kind of approach, it’s a very specific answer to a very specific question, one that we have found that clinicians have some tools, but not all the tools they need. So, something that was needed in the industry.

Q2: You’ve described the business as de-risked and ready for commercial scale-up now. Could you talk us through the key milestones that have brought you to this point?

A2: When you develop products in healthcare, there are multiple steps to go through.

One, you have to do a large clinical trial called a validation trial that says, I think my technology works, but I need to do it in a way that I really test it. We achieved that some years ago so that we could show that the products work.

You then have to make sure that you’re allowed to sell it in a regulatory environment. We operate under what is called CLIA regulations so that means that the regulators come in and establish that our lab and our test work fine, we bring in the tests into our lab and then we send out a result. That’s a little different from FDA, where you might put it in a kit and put it into the hospital and other people run it, we run it ourselves. So, that’s different regulations and we achieved those, just waiting on New York State, that’s the last one. Otherwise, all other states are covered.

You then have to think about, now I can sell my test, can I get paid for my test? As everybody understands, the US healthcare system is very complex in that area. We thought about that right from the beginning and thought about where we would house our lab for the best kind of environment that was the most up to date in transplant for reimbursement decisions under Medicare. That’s the MolDX region, the Palmetto region, and we got that about April of last year. That means that we have three parts of it. You get a code so they can recognise you in the system, a price so they know what that contracted price is, and then you get a coverage determination. That says, oh yes, we see this is useful, we’ll cover it and we got that in April last year so now that we can sell the test, know it’s useful and it’s paid for.

So, that’s really been the key milestones for us as we’ve gone along the way to commercial launch and last year was our real first year of being able to operate in that environment.

Q3: What were the biggest risks early on and how did you address them?

A3: All of those big milestones come with risks and obviously the way we addressed the validation was to do a multi-centre blinded prospective, everything that clinicians want, we call it ‘throw the kitchen sink at it’ kind of validation trial. It is risky because you’re really putting your test under extreme circumstances. It does reflect clinical reality for clinicians and so if you pass on that basis, clinicians tend to trust you a little bit more than if you’ve made a highly curated type of study to get the best results. So, we decided under the guise of ‘if you’re going to fail, fail fast’, that we would put it under the toughest of circumstances and therefore, if it comes out well, it can be trusted. That was the first thing.

The second thing is to hire the best team that you can get. The skill level that is needed in this area is quite immense and I’m extremely proud of our lab folks and our bioinformatics teams, they do an excellent job. This obviously played out well with all the audits that we’ve done under the regulatory environment, getting a clean bill of health.

For reimbursement, as I said, it was picking the right area for the most advanced knowledge of our kind of testing so that we were talking into the most educated audience and being able to present the best case that we could. Obviously with our results, obviously with our most comprehensive test, we provided a lot of data to back that up. After a very lengthy review, they gave us a clearance with no qualifications, which was outstanding.

I’m not sure whether that’s unique, we’re not terribly au fait with every test in relation to transplant in that way but we certainly know that’s not the case for us compared to our nearest competitors. So, we had advantages there that it was the most comprehensive with the least amount of restrictions.

We were very proud of that and now, it’s all about getting through to being able to expand commercially and I think last year we hired a small sales team to prove that case and we delivered some strong foundational results ready to expand and grow this year. So, we’re excited about this year.

Q4: Just turning to the financials, how would you describe Verici Dx’s current position?

A4: As we were expected to from last year, we did a raise. We said we would come back into the latter half of this year, and I think we’ve managed to deliver that. Our cash is slightly more robust than was forecast and our sales are pretty much to what we were forecasting as well. I think most people were encouraged by the fact that even though we got off to a late start last year, we were able to hold firm and deliver to our results and expectations.

So, I think that the company can always do with more money. We would always like to grow faster but we’ve been keeping to investors’ expectations and the milestones set by those investors. I think that’s encouraging for this year.

Q5: Where is the capital mainly being focused right now?

A5: Sales and marketing. Just all that commercial effort. We’ve expanded the team, we added two new salespeople, we added a clinical support, a logistical support and we’ve been doing more marketing. Healthcare is all about what we call key opinion leader engagement, and we’ve been going to conferences, we’ve been having speakers’ programmes and we’ve been doing webinars, all to get the word out that people are using this. In the real world, it’s performing even better than it did under validation criteria.

Q6: Looking ahead then, what does the growth opportunity look like for Verici Dx?

A6: We looked at the entire market because there’s quite a lot of repeat testing, it’s more than the number of transplants. So, we calculated that the immediate addressable market, which is the US, has a total of about $900 million of annual revenue.

We looked at that and said, well, how are we going to approach that market? It’s all about looking at the trust of the clinician, looking at how you engage with your competitors. We calculated that about a third of that is currently not using biomarker testing but will probably need to because there’s been a big initiative from the government and from CMS in particular to increase the number of organs being used. That means that they’re using more risky organs, so they’re going to have to test more to manage that aftercare.

There’s about $300 million that is currently being addressed by our competitors. Those mainly use a technology called cell-free DNA, it’s a late biomarker, it’s an injury marker. It’s a little bit like measuring the debris in the blood after damage has happened. So, we come in way earlier. We are like the check engine light rather than the ‘you’ve broken down and now you’re calling AAA’. So, we have some advantages in going head to head with more dynamic monitoring, this is very good in drug monitoring, etc. So, we have complete advantages there.

Where we’ve chosen to operate initially, which is at the first $300 million, and these are areas where it’s primed for a need but there is nothing that clinicians are really happy about using, they say that they can’t use other tests in that area and we can serve those areas. So, conditions such as delayed graft function where they don’t know whether it’s just slow in becoming operational in the body or whether it’s actually rejecting. It’s too early in the process for the other tests and yet we perform very well in that and that can account for these days anywhere around 40% of patients. So, these are big unmet needs in that industry.

There are other conditions, multiple organs, prior transplants, viruses, infections, etc, places where other tests can’t really operate and so clinicians feel that they don’t have anything. Now we’re being able to offer them what we call the low-hanging fruit. It’s good to go in, centres are prepared to implement you in their processes because they haven’t got something where they need something. So, that for us is a good entry point and something where we feel that we don’t really have very strong competition, if any competition at all.

So, that’s something that we said, well, OK, the first $300 million addressable market should be free and clear for us so let’s go there first and then tackle the other areas as we go through.

Q7: What are the main steps between today and full commercial scale-up?

A7: I mentioned that I have a small sales team. We calculate that you need anywhere between 12-15 people for national coverage and we have 4. So, obviously there’s room to expand the commercial team and the supporting people and marketing efforts. We never spend enough in marketing and when you’re really going to talk to clinicians in a large country like the States, that takes a little bit of time and money.

So, those are really the steps; buying ourselves enough time, funding ourselves to a level that we can really address this market properly and providing additional data points. Clinicians always love more data, and I think being able to prove how well it’s working in the real world is something that’s always useful, always a key point and a key cornerstone of any sales process to clinicians who are obviously looking for the best test at the best time for their patients. I think it’s just a little bit of amplification of what we’re already doing.

Q8: Just before we finish, what news flow should investors expect over the coming months?

A8: A little bit more of the same. I think that we try and indicate that we’re doing our jobs, we’re progressing, we’re growing and where we can talk about expansion of centres. We bring on new centres every quarter, obviously, I’m not going to announce every one.

News flow around more forays and success into the commercial reimbursement landscape. We’ve done a few, we’ve got contracts with Blue Shield and Blue Cross, but you would see more in terms of addressing what is about 30% of our patients in the private reimbursement landscape.

So, I think just more of the same in terms of the emphasis on our growth and amplification on our commercial rollout.

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