Good morning, ladies and gentlemen, and welcome to the NeoGenomics Second Quarter 2021 Earnings Call. [Operator Instructions] It is now my pleasure to turn the floor over to your host, CEO, Mark Mallon. Sir, the floor is yours..

Thanks Kait and good morning, everyone. I'd like to welcome everyone to NeoGenomics' 2021 Second Quarter Conference Call.

Joining me this morning from our Fort Myers headquarters are Kathryn McKenzie, our Chief Finance Officer; George Cardoza, President and Chief Operating Officer of our Lab Operations; Bill Bonello, President of our Informatics Division; Doug Brown, our Chief Strategy and Corporate Development Officer.

Joining on the call via phone from the California is Dr. Waller President of our Pharma Services division and via phone from the United Kingdom is President of is Inivata Dr. Clive Morris. Before we begin our prepared remarks, Doug will read the standard language about forward-looking statements.

Doug?.

Good morning. This conference call may contain forward-looking statements, which represent our current expectations and beliefs about our operations, performance, financial condition and growth opportunities. Any statements made on this call that are not statements of historical facts are forward-looking statements.

These statements, by their nature, involve substantial risks and uncertainties, certain of which are beyond our control. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual outcomes and results could differ materially from those indicated in the forward-looking statements.

Any forward-looking statement speaks only as of today, and we undertake no obligation to update any such statements to reflect events or circumstances after today.

Before turning the call back to Mark, I want to let everyone know that we will be making a copy of our prepared remarks for this morning's call available on the Investor Relations section of our website shortly after the call is completed. [Operator Instructions].

Thanks Doug. So we are really pleased to announce strong quarter two results highlighted by 40% annual revenue growth to $122 million for the quarter. All three of our divisions grew significantly over a depressed Q2 from a year ago. And importantly, we grew our core revenue 7% sequentially over Q1 of this year.

I'm especially pleased to note that our strategic growth areas of pharma services informatics and the NGS testing and clinical services were strong contributors in the quarter. And these growth areas now account for greater than one third of our total company revenue. Clinical revenues of 101 million represented 37% year-over-year growth.

In our clinical business experience a noticeable recovery versus quarter one, and this number included no contribution from COVID-19 PCR testing revenue. On a sequential basis, our core clinical cancer volume increased 8% with a record 281,000 clinical tests performed in the quarter.

While the quarter to recovery in volume is encouraging and strong volumes have continued into Q3 we are monitoring a few market related factors that may impact continued volume uptake in the back half of the year.

We have anticipated that our sales team would have full access to their customers by quarter three but that remains to be seen in certain territories. We believe that much of this can be attributed to the recent spike in COVID-19 cases driven by the Delta variant.

Additionally, market data shows that many patients are still not going in for critical screening appointments in key cancers continue to be under diagnosed.

We believe our strong sequential volume growth in quarter two is evidence that our clinical business will benefit as reopening of offices continues even if at a slower rate in some parts of the country. Our pharma services business continued to shine during the quarter, putting up record revenues of over $20 million with year-over-year growth of 55%.

Demand was also robust during the quarter as more than $40 million in new bookings growth signed contract backlog to a record $238 million exiting the quarter. This backlog gives us confidence that as we exit 2021 our pharma segment will be approaching $100 million in revenue and a runway basis up from just $20 million annually a few years ago.

It's also worth noting that our pharma services business continues to migrate up the value chain of our biopharma customers as we are winning a larger percentage of phase two and phase three opportunities.

These larger contract awards demonstrate the strong competence our customers have in Neo awarding some of their most important drug development projects to our pharma services team.

Our informatics capabilities, which improves the ability of biopharma companies to identify patients for clinical trials and provides these clients with commercial analytics to support product launches continue to be in high demand. Informatics is the fastest growing of our three operating divisions and the team continues to make strong progress.

While still relatively small, this business posted record revenues again in quarter two and you'll hear more from informatics division President Bill Bonello later in our prepared remarks. During the quarter, our team also successfully closed on two important acquisitions.

We are excited about the addition of Trapelo Health and Inivata into NeoGenomics. And while still very early days, we can already see multiple opportunities to drive growth in support our overall strategy of bringing innovation to the community oncology market.

Trapelo Health closed in April and the acquisition is now fully integrated as a subsidiary of our informatics division. You'll hear more about Trapelo in the informatics updates later in the call. Inivata closed in June, and our integration activities are well underway.

We plan to leverage the advantage of NeoGenomics strategic position in commercializing our residual disease and recurrent assay or RaDaR with a multi pronged strategy for success.

As we've discussed, our first priority is ensuring rapid submission of RaDaR to -- reviewed the plans and progress of the team and we remain on track for a submission around the turn of the New Year assuming a typical review period, we'll be able to launch into the clinical market in the middle of next year.

Since we have acquired Inivata we've accelerated the acquisition and retrospective testing of multiple cohorts of samples in multiple tumor types to support the initial submission and launch in future areas. Another priority is to gain biopharma support for RaDaR.

Our pharma services team is now fully engaged in supporting Inivata in pulling through a large and growing portfolio of pharma opportunities. There's been a clear recognition by biopharma teams of the companies of the leading sensitivity and specificity of the RaDaR assay.

We expect to leverage our strong relationships with nearly 200 biopharma companies to generate revenue and aid in building and evidence base for treating minimal residual disease with RaDaR.

MRD testing will play an important role in the development of therapies particularly in places like the new adjuvant setting, as of course in recurrent monitoring. Studies in the adjuvant setting are one example of how MRD RaDaR specifically can be used to transform drug development, it could be an opportunity for quick successes.

Today, approximately 70 percentage of patients with early stage cancer are cured by their initial treatment. However, it's difficult to know which patients and as a consequence, patient enrollment into adjuvant clinical study includes large numbers who do not have residual cancer.

By utilizing a test like RaDaR to facilitate more effective trial enrollment pharma responses can help healthy patients avoid unnecessary treatment, reduce trial sizes, improve the quality of readouts from the trial and reduce cost along the way. We believe biopharma adoption will be an important part of success in the clinical market.

And we will utilize the relationships and oncology expertise of our base clinical sales team who have been calling on our key clients for an average of six years or more. We recently built out an additional precision medicine managers team to focus on driving the next generation sequencing and liquid biopsy adoption.

This team will be in place well ahead of our planned RaDaR launch, it will be tasked with helping drive uptake. Also earlier this year, we struck an important commercial arrangement leading breast cancer oncology testing company Agendia to co-commercialize RaDaR with breast cancer focused physicians upon launch.

We view the partnership with Agendia and the growing U.S. sales force of over 40 breast cancer specialists as a focused way to grain more on the street selling RaDaR at a reasonable cost.

We've already received multiple inquiries from other companies who have sales teams of a similar size and reach that are focused on various other cancers sites and we're actively evaluating these opportunities.

We believe that RaDaR best in class published analytic sensitivity of 97% at 20 parts per million of circulating tumor DNA or 0.002% variant allele frequency is a true differentiator. This elite level of sensitivity at such low concentration allows RaDaR to make calls other assets fundamentally may not be sense enough to make.

We believe these other potential partners are recognizing the assays differentiation as well. Finally, we believe that RaDaR clinical decision support software can be a technological multiplier for our sales efforts as the platform is adopted and additional clinical evidence is published for minimal residual disease testing and treatment.

Fast reimbursement. comprehensive evidence generation, success with biopharma customers, targeted disease opportunities with quick wins are possible in a multi channel approach the selling will be the success factors to make RaDaR our leader in the MRD market and we are rapidly working on each.

Overall I'm proud of our team to quarter 2 perform and my first quarter as CEO of NeoGenomics and excited about the early progress from our two recent acquisitions. From the big picture perspective, I've been very impressed by several strengths of Neo in my first 100 days on the job.

First, it's just how comprehensive oncology platform and NeoGenomics truly is, is I have dug in, I see how broad our portfolio of services provides a value proposition to all the constituents of the oncology ecosystem, providers, pharmas, payers, and of course patients.

Our portfolio of multi modality solutions is comprised of hundreds of assays that provide time sensitive biomarkers for market specific answers. For oncologists, pathologists, research scientists and pharma trials themes.

Our customized targeted panels allow us to provide the right information at the right time for providers and patients at the right price for our direct bill and third party payers. In that broad menu base menu that differentiates in clinical is also of great value to our biopharma customers. It is the real driver of growth for us.

As we test nearly half a million patients per year, the value of the data and related informatics capabilities are gathering or we are gathering only continues to snowball every day. Critically, these strengths have translated into leadership in three key franchises.

We are a clear leader in diagnosis of hematologic cancers, with an especially strong position and have strong franchises in both breast and lung segments where we run more than 100,000 tests annually. These are real platforms for both today and in the future.

I must say that I've been equally impressed by our culture, as I've now had the pleasure of meeting hundreds of my fellow teammates and NeoGenomics. And this is truly a feeling of patient first mentality at all levels of the organization as I have visited many of our facilities is obvious that our lab employees are dedicated to patients are.

This consistent dedication has translated into industry leading turnaround times in many of our test modalities and is also reflected in both our strong Net Promoter Scores and the extremely high customer retention rate. And I know we can do much more.

We believe that the commercialization of the RaDaR assay can help transform the cancer care paradigm for millions of patients in need of cancer recurrence monitoring.

We see opportunities to drive broad adoption of a leading clinical decisions software for our oncology customers to help them navigate appropriate testing presentations from both technology and cost benefit perspective. And while we are the leader in the U.S. oncology market, I see so much more opportunity outside the U.S.

as we look to further globalize our offerings. We have multiple facilities around the world that have ample capacity to scale. And we have ongoing discussions with various biopharma companies regarding our ability to further support them globally.

Along with these organic growth opportunities right in front of us, we also have corporate development and inorganic growth opportunities that we have no intention of slowing down on.

We are strategically well-positioned and are well capitalized for further deal making as we look to keep pace with the constantly changing and highly competitive marketplace in oncology. When I put it all together, I see a very well-positioned, very well diversified player and one of the most attractive end markets in the world.

And I believe all the opportunity in front of us, puts us in a position to accelerate our historical mid teens top line growth rate over time which will enhance our margins as well as we fill up our laboratories and continue to implement efficiencies.

You can tell I am very excited to be part of NeoGenomics, and I could not be more optimistic of the future of our company. I'll now turn the call over to Kathryn McKenzie to discuss some of the other details of quarter 2 financial results. .

Thank you Mark. Second quarter clinical division revenue grew 37% year-over-year, driven by a strong bounce back in clinical volume compared to the depressed volumes during the initial wave of the pandemic during the second quarter from one year ago.

As a reminder, we made the decision to wind down our COVID-19 PCR testing capabilities in quarter one, and we had no contribution from COVID-19 testing in quarter two compared to 2 million in the same period last year. Clinical division revenue per test was $360 in quarter two compared to 362 for the full year of 2020 and $351 in quarter two of 2019.

Pharma services revenue grew 55% year-over-year. Growing continuing its rapid growth trajectory. Demand continues to be very strong and we signed over 40 million in new booking, exiting the quarter with a record 238 million and backlog.

Our total gross margins of 43.5% in quarter two included amortization of intangible assets related to develop technology acquired through the Inivata acquisition.

Excluding the amortization of these acquired intangible assets our growth margins improved to 44.1% in quarter two, driven by efficiencies on increased volume in clinical and higher revenue and our pharma services division, more consistent sample volumes allowed for more predictable staffing levels, and we were able to see more normalized leverage on our largely fixed cost COGS infrastructure.

Gross profit increased 11 million sequentially, on only 6 million of revenue growth. Compared with a year ago, gross profit increased 25 million on a 35 million revenue increase. These levels of incremental gross profit provide confidence that gross margins can improve as we continue to grow.

And we believe that over a series of quarters, we should be back to previously achieved gross margins approaching 50%. However, we've continued to see the same temporary labor and supply chain constraints that the rest of the country is experiencing.

And these capacity constraint challenges combined with high demand are continuing to affect service levels and cost protest.

Operating expenses increased $28 million year-over-year to 75 million, primarily driven by onetime acquisition related costs, expense contributions from the recent acquisitions of Inivata and Trapelo, increased commercial costs on higher revenues, and additional investment to support growth.

Concurrent with the completion of the Inivata acquisition, we recorded a gain of $97 million within other income related to our prior minority investment in Inivata.

This gain represents the amount by which the fair value of the company's minority investment and Inivata immediately prior to the acquisition exceeded the carrying value of its previous health equity interest in purchase options.

Adjusted EBITDA of 4.6 million in Q2 reflects improvement in our core cancer business, offset by expense contributions from the recent acquisitions of Inivata and Trapelo and higher payroll in commercial costs, and other certain personnel related expenses. Turning to the balance sheet.

We exited quarter two with $572 million in cash and marketable securities which excludes an additional 4 million in restricted cash designated for construction of our new state of the art laboratory and global headquarters in Fort Myers, Florida.

During the quarter, we utilized 390 million in cash to exercise our purchase options to acquire the remaining on equity in Nevada, and raise gross proceeds of 200 million and a related strategic private equity transaction. We also utilize 36 million in cash for the acquisition of Trapelo which was announced in March and closed in April.

We are maintaining our previously provided annual revenue and adjusted EBITDA guidance based on strong second quarter. I will now turn the call back over to Mark..

Thanks, Kathryn. As we've done in previous quarters, we'd like to dedicate some time on this call to providing our investors with a progress update on one of the most exciting areas of our business.

For this course call I've asked the President of our informatics division Bill Bonello to discuss the exciting projects he and his team have been working on.

I'll turn the call over to Bill now, Bill?.

Thanks Mark. It's great to be able to speak about our informatics initiatives. The informatics division is building data and technology solutions to improve patient care and drive growth.

In two short years, we've grown from a standing start to a team of nearly 60 people and are progressing nicely towards our longer term goal of establishing a $100 million business.

In our core informatics business, we provide products and services to life science companies to support clinical and commercial analytics, clinical trials, and digital pathology. Over the past two years, we have engaged in over 59 contracted projects with 26 different companies. And we have nearly 100 unique project in our pipeline.

We are engaged with many of the largest global pharmaceutical companies, often for multiple projects, as well as several leading contract research organizations. I'd like to highlight just a few of our current projects to give you a better sense of the type of work that we're doing.

In one case, we help support the commercial launch of a non-small cell lung cancer therapy by analyzing biomarker testing patterns among both oncologists and pathologists. We use this information to identify potential sites for a phase two clinical trial as well as do identify gaps in tests.

We also constructed patient cohorts to identify individuals that might benefit from the therapy or mean follow up biomarker testing and shared this information with treating physicians within 48 hours of FDA approval. Finally, we implemented a sponsor testing program to alleviate patient financial burden.

We have several other projects where we're identifying patients that might be candidates for a specific clinical trial, proactively following up with the treating physician and facilitating enrollment. We also have several other projects where we have identified gaps in biomarker testing to support commercial initiatives.

Another area where we have engagements is around digital pathology and image analysis. We are engaged with several companies to provide annotated digital images in some instances supported by our own proprietary machine learning algorithms. We're also very excited about Trapelo Health, which we acquired in March of this year.

Trapelo Health is a precision oncology company focused on clinical decision support for both test and therapy selection as well as streamline prior authorization for both testing and treatment. This comprehensive order to result perspective differentiates Trapelo from any other clinical decision support tool on the market.

As we all know, for precision medicine to work, patients must be tested for the appropriate biomarkers in order to even know that they're a candidate for a therapy or clinical trial. And the front end, Trapelo identifies which biomarkers should be ordered for a specific patient and which specific lab tests include those biomarkers.

The product is designed to be lab agnostic, enabling providers and payers to designate their own preferred laboratory networks. Real world data underscores just how important this biomarker guidance is.

We know that up to 35% of patients with non-small cell lung cancer have actionable genetic mutations, and up to 55% of patients with metastatic non-small cell lung cancer patients risk excuse me, long term have clinically relevant mutations.

Nevertheless, less than 25% of non-small cell lung cancer patients receive testing for all four of the most common biomarkers, and just 7% of patients receive testing for all seven genes that are included in clinical guidelines. And that's just one example.

On the back end, Trapelo identifies which therapies in clinical trials may be appropriate for an individual patient based on the test results and other clinical information. This guidance is also critical ensuring the highest quality patient care.

About 80% of treatment occurs in the community and most of those in oncologists are seeing a very broad range of cancers making it next to impossible to keep up with most current science and the guideline. Also, guidelines alone can change at a pretty rapid clip.

Sometimes a guideline for a specific cancer can change as many as six times over the course of the year. All of the recommendations for both testing and treatment are supported by scientific evidence which has been collected and curated into a proprietary knowledge base which is supported by our own team of PhD curation specialists.

While it's still early days, client response has been overwhelmingly positive. And we are in active discussions with a large number of provider organizations, payers, and electronic medical record companies.

We will also be integrating the testing portion of clinical decision support into our NeoGenomics online order process and hope to have that product available to select clients in the fourth quarter of this year. Now, I will turn the call back over to Mark for some closing remarks. .

Thanks, Bill. So in summary, I believe our Q2 results have confirmed that our strategy is working and we will ensure value creation for shareholders and patients. We achieved 40% growth driven by record test volumes in a clinical service division and grew gross profit ahead of revenue.

Fully one third of our business now comes from our growth drivers a pharma services, informatics and NGS testing. We visit and drive more growth to potentially transformative innovations to cancer testing with the acquisition of Trapelo and Inivata with the RaDaR MRD test.

We remain laser focused on transforming the lives of cancer patients by being a leading cancer testing and information company.

Dough you want to take us to Q&A?.

Thanks, everybody. At this point, we would like to open up the call for questions.

If you are listening to this conference call via webcast only and would like to submit a question, please feel free to email us at dougvanoort@neogenomics.com during the Q&A session, and we will address your questions at the end if the subject matter hasn't already been addressed by our call-in listeners.

[Operator Instructions] Operator, you may now open up the call for questions..

Thank you. Ladies and gentlemen the floor is now open for questions. [Operator Instructions] Our first question today is coming from David Westenberg at Guggenheim. Your line is live..

I had a mute issue earlier. Okay, perfect. Okay. Good quarter. And nobody's raising guidance, because nobody knows what's going on with patient volumes and I guess the Delta variant but when we ask about July, people say they're coming in, we just can't detail the sales force. So I don't mean to be overly pointed here.

But how genuine is this concern in the back half of the year in terms of patient volumes and how should we model cadence of volumes for the rest of the year given this kind of dynamic and if he can walk through kind of the genuine Delta case the genuine I can't detail, the sales force can't detail kind of case, and the puts and takes with that and since my question is complicated, I'll just stop with that one question and get to next..

Thanks, David. Yes. So unfortunately the evidence have an impact on sort of access to access offices is real. We've been getting examples from pretty much across the country of hospitals that have had been open to sales representative closing.

And what I think certainly it's causing us to have taken seriously is that a number of these are in places that hadn't closed before. So particularly we're seeing reduced access in places like Florida and Texas where I think that we're actually these places have set records above even the previous records for COVID cases.

So on the positive side our sales team has been working both with customers directly face to face, but also virtually. So we've built up a lot of capability in this area and they are super passionate about continuing to make a difference for cancer patients. So we're going to be working hard to keep driving the volume.

We have good momentum coming out of the second quarter. But I think it's really too early to say what's going to happen and we know the spike is occurring, and it is causing changes in practices in multiple institutions around the country. The question is how long will this last and I don't think we can really give you any more guidance than that.

Did I answer your question..

I did want to get the cadence should we modeled and down Q3 and then maybe move up Q4 just a clarification there..

Go ahead Kathryn..

Yes. So I definitely based on what we're seeing with the spike in COVID cases and the access, that would be a good assumption on how I would expect that to come through. Again, it's unknown as to what the impact will be in Q4 at this point, but I would expect a softer Q3 compared to Q4 as we get our handle on this..

Thank you. Our next question today is coming from Brian Weinstein at William Blair. Your line is live..

A little bit about pharma services side. You talked about kind of moving into phase two phase three trials here. I'm just curious about what that means in terms of size of deal that that brings on and the opportunity there. And then, as you think about the broader pharma services side, you highlighted ways that you're winning.

But can you be a little bit more specific on when you win, why you win, and where there are maybe some gaps where competitively you continue to need to fill things out in order to be even more effective there. Thank you so much..

So I'll say a word or two about the shift upstream with pharma companies. And I'm going to ask Gene to talk about one of the reasons why we win when we win. And you can expand on the first part of the question as well. So we are moving into the phase two, phase three, where first of all, I think, is logical for two reasons.

One, we've had tremendous success in some of the earlier phase work over the last couple of years. And we've built really strong relationships with multiple companies. It's only natural as projects progress into later states that they want to continue to work with a company that's having great success.

I think the other thing that supports moving in the later stages we really have significant capacity and capabilities. As these studies, the bigger studies they want to work with organizations they know can deliver. And I think we've shown the way to do that.

It's very exciting for us, because once you learn have acquired the business to a phase two or phase two program, they can be quite large, and that can secure test revenue for a good number of quarters. Now, of course, the time to test those studies can take a little bit longer. So we have to, we're going to continue to watch and see how our 4Q goes.

But overall, we're super excited about this because it really represents incremental business in some of the most important work that our customers are doing.

Do you want to talk about why we're winning?.

Sure. Thanks, Mark. In terms of the shift, from research/phase one, phase two trials to phase three, one of the large contributing factors to that is our global capabilities. With the opening of our site in Europe and Singapore, and now China. This provides a global solution to our pharma companies' needs.

And so therefore, we are at the table for those phase three discussions and when it comes to providing full services in oncology I think we win across the board in terms of that global solution. Key areas that we have identified include being able to provide companion diagnostic services ex-U.S.

We provide a holistic and terrific service within the U.S. And we seek to bring that ex-U.S. because that is what our clients are looking for.

Does that address your question?.

Yes. It does. I appreciate it. Thank you. .

Thank you. Our next question today is coming from Alex Nowak at Craig-Hallum Capital Group. Your line is live..

Great. Good morning, everyone. The company last quarter spoke to a number of investments that team is making on the RaDaR asset to get it ready for prime time. But I'd say at the same time, the two main competitors out there they're spending very large amounts of money getting their respective assets ready.

Can you maybe expand on the competitive environment now that you've had some more time within Inivata under the hood? And then what additional investments Neo's really going to need the base to get the test ready for a clinical launch next year?.

Sure. Let me say a couple of words about how I'm thinking about it, but then I would like Clive to talk a little bit more about specifically what we're doing to get ready.

So I think the first thing I was looking at when you're thinking about launching new technology is the profile of the product and Clive can comment a little bit on this but as I've come in and really seen the data that we that's been published in what we're developing internally, I'm very confident that this good or better and ability to really detect at very low levels, sort of cancers, before they're recurrent, or recurring from a visual perspective is outstanding.

And that's going to give us a strong base on what I think is going to be the key dimension of competition. In terms of the investments, and companies are making investments both in evidence generation as well as in, having sales forces those are a surprise.

These companies are starting from a position where they don't have large customer bases, large initial volume, and long history in oncology and conversely. Neo has all of those.

We have a customer base of over 4000 customers, we're doing a million tests a year and a half a million patients and we've got an experienced sales team now over 60 sales people. We've got a big customer service group, we have over 100, pathologists, we have really an incredible infrastructure and a starting point, as we move into this.

Absolutely, we're going to have to have dedicated additional resources. And we're defining what that's going to be. And we'll have those in place for launch middle of next year.

I'll pause there and let Clive to maybe say a few more words about the profile, and remind us about why we're so excited about the profile of the product, and how he's thinking about competing in the marketplace.

Clive?.

Yes thanks, Mark. And thanks for the question. Yes company, obviously endorse everything that Mark just said. I think the sensitivity and specificity we see in the assay. We know is absolutely critical for these early stage cancer patients who've already undergone treatment and then you're detecting microscopic disease effectively.

Therefore the blood traces of DNA are very low. And we believe that the RaDaR assays has a fantastic compelling profile to win in that space. We believe sort of working on a range of different aspects, you talked about evidence generation and sort of getting ready for clinical launch.

So we've a number of clinical cohorts that we're exploring across a range of tumor types. As Mark mentioned, we're looking for submission for initial reimbursements around the turn of the year with then leading to launch with a reimbursed test towards the middle of next year.

But overall, we see many sort of potential sort of different indications we could approach with an asset like RaDaR and we're building that evidence using a mix of either ongoing or archival study cohorts where we can access them but increasingly also seen sort of prospective studies which of course may be more practice changing in the long term, but take a while longer to bring through.

So we'll start that with more observational data getting into interventional, into prospective and ultimately they will obviously drive the long term outcomes here. And within those prospective studies with academic collaborators, with cooperative group collaborators, and indeed, with biopharma as Mark mentioned. so we're building that stable.

So as I say overall we believe the market is right at the beginning of the evolution of this sort of clinical testing market. It'll continue to grow. I think, and we'll see sort of additional sort of tests and indications being reimbursed. As I'm sure you're aware today, there is colorectal cancer coverage.

There is pan cancer coverage more generic LCD from the multi-x group that we and others will also look at using. So I would expect to see sort of increasing indications building over time and as Mark said we enter to be partaking within that.

Alongside the evidence generation, of course, there's a lot more than needs to go into successful launch from the key opinion leader development thinking through physician education, how do you think about a course then through into sales and marketing, and we're in the process of planning those ads in more detail commensurate with the launch timing Mark mentioned.

hope that answers the question..

It does. Very helpful. Thank you. .

Thank you. Our next question today is coming from Mark Massaro at BTIG. Your line is live..

Hey, guys. How's it going? Thanks for the questions. I guess. If I can ask a two parter.

The first is curious if you're seeing any increased adoption of the envision first lung test, and then I wanted to ask Bill Bonello there's been several interesting digital pathology, machine learning AI type companies raising some money this year and within the last 12 to 18 months or so.

Have you had a chance to evaluate your internal initiatives relative to some of the other leading platforms in the industry? And I guess, maybe Bill can you remind us how long you've been developing your algorithm and how you think it's differentiated relative to others in the field? Thank you..

Okay, let me take the update on envision first lung is one of the things I've been looking at closely. So we've seen steady growth for the beginning of the year. And so that's good. But we want to do better and so we're definitely taking a couple of steps. As I've counted the team to see what we can do to accelerate growth in envision lung.

This will be the number one focus of the new precision managers medicine team, the precision team of 10 sales representatives that will be both focusing on oncologist. This is in addition to the 50 that are already supporting the product. These people come from a very clear background working in oncology, selling the most advanced tests.

So excited about that. We're also adding a couple of dedicated resources in our customer service team to expedite reimbursement and also to focus on where we have opportunities to reflect from solid tissue tests over to envision lung and really do a much better job with that.

But importantly, we're really going forward with a new positioning of talks about patient first as our approach in the lung cancer space. Fully 60% of patients in lung cancer patients really are eligible under the current LCD for envision first lung, and it's the best choice for these patients. And we're going to be really emphasizing that.

These are patients who really is medically contracted indicated to do a biopsy and you know the physicians are clear, they probably won't be able to get enough of the tissue. And we can go right to envision in the first line, which is a great profile.

So I think with a really stepped up effort, clearer messaging, further investment in resources we can take what is a growing, test and make it into even the faster growing tests. So we'll be putting a big emphasis on the second half of the year.

Bill you want to take the second part?.

Sure. Thanks a lot for the question Mark. We know most if not all of the companies that you're referring to. And in many instances, we're actually working with those companies in various ways. I would say that the kinds of algorithm work that we would be doing in our projects are fairly basic.

Things that make the R&D work easier for pharma customers who are using digital images to do their research. So that may be things like slide circling, tumor calculation, histology, detection, etc. The distinction I would make from some of those other companies and what we're doing, we are not currently working at all on any kind of a clinical assay.

That is not within scope of what we're trying to do. It doesn't mean that it couldn't be in scope of what we try and do at some point in the future. But we would need significantly enhanced resources and capabilities to be able to do that.

I wouldn't say the one thing that we have that differentiates us from many of the other players is we probably processed more digital images in a year than anybody else in the marketplace. And we have dozens and dozens of pathologists that can help with training and evaluation and validation of algorithms as they're created.

And hence one of the reasons that many of those companies want to work with us, as do many of the pharmaceutical companies. So hopefully that gives you some sense of where we're at..

Thanks, Bill. Thank you for your Mark..

Yes, that was great. Thank you. .

Thank you. Our next question today is coming from Tejas Savant at Morgan Stanley. Your line is live..

Hey, guys, good morning. So just a couple of quick follow ups Inivata and then I'm a separate question for Kathryn.

So on Inivata Clive do you envision different versions of RaDaR for the recurrence detection versus response monitoring indications? And secondly, in your mind how important is FDA approval for broader adoption of MRD as a modality in general? And then, for Kathryn can you just give us an update on when you expect the Fort Myers lab to be fully operational any color on OpEx cadence you're heading into the back half of the year?.

So Clive you want to take the first part and actually since we've got George Cardoza here who's responsible for our lab operations, I'm going to have him give you an update on Fort Myers, if that's okay..

Sure. Settling back. Yes the beauty of an assay like RaDaR is its completely suitable for both the residual disease detection following surgery, and then the ongoing monitoring potentially for the recurrent disease. So we create the output a highly sensitive, we're tracking a high number of variants.

So we're looking at 48 known variants per patient with great sensitivity which means even if there are changes in the landscape, the genomic landscape of the patients, the majority, if not all of those will be conserved.

And we then have a very good detection rate and the early data we've presented in breast and lung cancers show that actually we can detect the recurrence many months earlier than actually using conventional mechanisms. So we can use the same test really, for both of them is the short answer to the first question.

In terms of FDA the assay has been built with a view to moving through the sort of LD as an LDT initially, and then with a view to then future FDA. As we've already said, we have an FDA breakthrough device designation already, and we were discussing with pharma.

And I think certainly, early on, I think the working with pharma, I think that FDA approval ability and access is key, because clearly the drugs that are tested these become the companion diagnostics for those therapeutics in the future.

So we want to make sure we're ready to be performing the regulatory clinical trials with pharma partners under four regulatory scrutiny, and oversight and then of course, as those trials read out, hopefully positive, then of course, we then naturally partnering with the pharma company to run those through as companion diagnostics.

Ultimately, of course, then as they are approved, that then further reinforces the clinical use of key and guidelines and everything else and eventual testing. So they will continue to drive the uptake of such testing long term.

So we see that FDA readiness and eventual FDA approval as a key part for the certainly the short term biopharma and the long term clinical adoption..

Sure. Yes. No. I drive by the Fort Myers headquarters every day. And it's looking really nice to come so far. And it really looks beautiful. And I think the team is very excited. There's two buildings, the admin building, which will be the corporate headquarters, that's obviously the easier one to move and that will happen fairly soon.

The laboratory though, is open right now. We have in the laboratory doing the equipment validations, doing testing validations. Obviously, all of these tests have to be revalidated in the new facility, which does take a bit of time.

But the team is certainly working hard and our expectations right now we're in the fourth quarter that we will be open, we will be testing in the new laboratory facilities. So the team is very excited.

And also just in terms of the capacity and the ability for us to streamline some of our workflows or our Fort Meyers facility is, is a bit dated, and we are fairly cramped in that facility.

So we're very excited to get over into open concept laboratory which I think is going to allow some efficiencies and they really ability to scale our growth over time. So the team is extremely excited about the new facility..

Got it.

and Kathryn on OpEx?.

Go ahead Kathryn. Do you need to repeat the question..

Yes.

Can you repeat the question on OpEx?.

I just wanted to get your views on OpEx cadence heading into the back half of the year.

I mean, anything particularly noteworthy 3Q versus 4Q?.

No, consistent with what we said before, we're seeing some pressure in some capacity constraints that could be impacted in that third quarter and fourth quarter related to COVID. But there's no significant other impacts between the quarters..

Perfect, thank you..

Thanks Kathryn. I'm just going to going to want to sort of clarify or point out something that maybe is sort of obvious to us but probably we could do a better job of clarifying and at the thought of as Kathryn was answering the question of sort of OpEx which goes to the resources.

As we're getting ready for the launch of RaDaR we have in place already 60 sales of very experienced sales people at Neo. We've got the partnership with Agendia which is going to add 40 very experienced people.

So a year before the lunch we've got in place 100 highly experienced people actively selling into these markets and we have backing them up very substantial customer service team, very substantial medical team, actually with Neo we're talking to over 100 medical doctors and PhDs.

And so I think this is a starting point that would be, I put up against any lab that was launching a new test in the last few years as a starting point. Now, we're going to also work on what is the additional dedicated resources that we need to have in place for the launch.

But make no mistake about it, and we have the resources to compete in this market and what's great is they're already experienced calling and customers and in place today. So just wanted to kind of highlight that and make sure we're clear.

Can I take the next question?.

Thank you. Our next question today is coming from Mike Matson at Needham & Company. Your line is live..

Yes. Thanks. Hi. Thanks for taking my questions. I guess, just following up on count you just made about the number of reps you'll have selling RaDaR.

I was wondering, I mean, is it realistic to assume that this could have add a couple points to growth maybe in the 20 2003 timeframe if not 2022? If you're 500 million or something in revenue, I mean at this adding 5 million to 10 million and pretty short orders. That's crazy or so..

So what we have said and so no, it's not crazy to be clear that we can add material impact and growth in 23. we've said that in we see 21 and 22 is the year we're focused on getting reimbursement and getting resources in all the activities in place and focused on driving pharma sales, and making sure we're building the evidence.

But as we get into 23 we definitely expect to see sales starting to come in on RaDaR in a material way, and especially in 24. So I think you are thinking about it just the right way..

Okay, great. And then I wanted to ask one on M&A. You've done a couple deals here recently. It sounds like you call that out in the prepared remarks, as you're still looking at other things. So the deals you've done seem to be more kind of technology oriented, I guess, if you will one in IT and one in terms of specific tests.

But so is that the main thing type of deal you're looking for? Would you do deals for scale or breadth? Or you're just an overview of kind of the approach? Thanks..

That's a great question. I'm going to have to Dough to answer that please..

Yes. Thanks Mike for the question. You're right. I mean, I think there's been an evolution how we've gone to market with M&A. The first couple deals were about scale. And the last three we have done are about technology. We are adding a test.

When we think about more scale transactions, frankly, it's on the pharma side and it would be probably from a global perspective, as we think about clinical it might be about adding more technology into the channel and then in informatics we could also look for scale there as well.

But we have a lot of opportunities that we're evaluating and as Mark echoed, it continues to be a major driver of growth here..

Thank you. Our next question today is coming from Matthew Sykes at Goldman Sachs. Your line is live..

Good morning, everybody. Hey, thanks for taking my questions. Just two for me.

Just the first one, my apologies if you guys have outlined this in previous calls, but any additional color on the economics for the commercialization agreement with Agendia or RaDaR ? And then what percentage of volume do you think you expect to run through Agendia versus your own in house sales? I know you mentioned sort of a 60 in house sales people versus 40 at Agendia but their expectations for how the volume might look in terms of how RaDaR is going through into the market?.

So we haven't communicated I don't believe the economics of the details of the agreement with Agendia. We see that as confidential information. I think that's the first thing and Clive if I missed anything jumped in. The second point in terms of volume again I think it would be premature to try to estimate volumes going through Agendia.

What I would say is clearly Agendia is a very successful and experienced organization in the breast cancer market. They're driving significant growth of their products with mammoprint and blue blueprint. And they have tremendous capabilities, particularly in evidence generation.

So they're, I think, a super exciting and then you add that together with Neo, which has is not deleting one of the leading positions in breast cancer testing.

We do, as I mentioned, I think earlier in my remarks, we do over 100,000 tests a year which I think is fantastic and these patients are patients that potentially could be your early disease patients or have been treated curatively that are going to need an MRD test to confirm that there's Medicare.

And they're going to be great candidates to transition to recurrence monitoring. So we're super excited in the breast cancer area. I think the profile that RaDaR brings with its sensitivity and specificity is outstanding. And so I think this is going to be a great opportunity. And Clive you want to add anything..

And I'd support that the only two additional bits I'd say is kind of clarification because Agendia we are focused exclusively on breast cancer, whereas, of course, a test like RaDaR has utility across other tumor types in lung and colorectal and other so. Again Agendia will be driving the breast cancer part of this alongside efforts at NeoGenomics.

And the other part is the agreement we have with Agendia also covers the EU, not just the U.S. So again, in terms of bringing that breast cancer channel and commercialization to the European Union as well.

So just two things to think about it say, yes they're complimentary in many ways, though will help to drive that breast cancer alongside in house efforts. And there may be additional partnerships within the future as well in different areas and different geographies.

Something we're currently looking at around how do we get the test which is we believe a great test to as many patients who need it as possible as quickly as possible..

Helpful. Yes. That's very helpful and then just lastly, more bigger picture. When you were talking about pharmacy services it sounds like there's an opportunity for ex-US. You mentioned diagnostics. I'm sure there are other things, do you have sort of a plan in mind in terms of expanding that business ex-US and growing it. .

Sure. We are evaluating several ways to do just that. As you know, companion diagnostic offerings include a multitude of factors, including reagent quality, compliance. So we're looking at building it versus buying it, and assessing what we have and what we might need.

So I know that's vague, but there's a lot of different ways that we could go about that expansion, including doing it ourselves or looking at M&A. Yes. I would just add maybe two points on this. And it's also what I've just overall, what I've seen in the pharma services business that excited me. So one is, the team is extremely effective at partnering.

We work with other labs. We work with other like we work with certainly CROs and we work with some of the devices, test kit manufacturers very closely. We have announced a couple of exciting partnerships already in China that will be collaborating to run studies locally.

And I think one thing that's true with labs business is that to be successful globally, you certainly have to have the physician around the world.

And we do that but you've got to be able to partner because diagnostic testing is so locally driven that if you can't sort of collaborate and partner and I think this is something that Neo does exceptionally well.

And the other thing that is really excellent, not just in the driving global or ex-US opportunities, but it's been core to the success of the customer focus that they are renowned for here in the U.S. in a clinical lab services is what they're bringing to pharma accounts. We focus on pharma full of the front and center. We are really responsive.

We're able to customize tests. We have fantastic test service levels, and a mindset of really customer first. And I think that has been a core to the success with pharma companies because they want a company that like the only thing that thinking about is how do we deliver on the study in front of us and nobody does that better than Neo I believe..

Does that answer your question?.

Yes. That's great. Appreciate it. Thank you, guys..

Thank you. Our next question today is coming from Derik De Bruin at Bank of America. Your line is live..

Hi, good morning. Thanks for taking the question. Most of them have been answered. But I just want to clarify a couple of things. Can you talk a little bit more about the R&D investment and how that's going to ramp I mean, obviously, with the Inivata coming in, that's going to pick up significantly and then I have a follow up..

Kathryn you want to talk about R&D and ramp of expenses overall?.

Yes. The addition of Trapelo and Inivata definitely increasing our future R&D expenses. We've mentioned before Inivata burning around $3 million a month in cash. And a lot of that is focused in R&D.

We do expect in the back half of the year that you're going to see increased R&D related to Inivata in particular, as we do prepare for the exhibition around the turn of the year was said before, that could be about $13 million to $15 million a quarter.

And then again, as Mark mentioned, we are looking going forward as we are preparing for future years at what that investment will look like to support the further development and commercialization of RaDaR..

Great, thanks. That's what I was looking for. And just on a, I just want a bigger question on the MRD market. I mean the data from the looking at the literature and then just from some of the other stuff coming out some of the other companies. I mean, it looks like they're particularly for cancer recurrence.

There does seem to be good indications that you need, or that certainly the data is enhanced by adding an epigenetic component to it in the analysis versus the personalized approach.

And just sort of your thoughts on the need to maybe expand the assay to look at epigenetic markers and just your thoughts on when can we expect to see I guess, some data on studies, sort of comparing the two approaches? But just from the overall market? Are you aware of any evidence out there?.

Sure.

Clive do you want to take that?.

Yes certainly. So thanks for the question. Cognizant of time, and I'll try to be very brief. But essentially, people are really searching for sensitivity to levels of DNA, cancer DNA and these early stage cancer patients who have undergone therapy are very low. So traditional sequencing with fixed panels tend not to be sensitive enough.

So the two avenues people have pursued is one is to try and personalize. So you're tracking and no number of variants, down that route. The other one is to move into epigenetics to try and look at other things that may be more abundant such as the epigenetic changes, and that you can see in for example, with the test.

We believe that actually, really, and both of those can improve sensitivity. But actually, based on what we're seeing on our sensitivity that we see with RaDaR between the technology advantages and the tracking the high variance, we're very pleased with the levels of sensitivity that we see.

And not say they couldn't be further improved by adding other markers to be determined what they are, but for what we're seeing today we believe that we'll have an incredibly sensitive test there that that will be very competitive.

So we may look at these things in the future but there's no imminent plans to add these and based on things like recurrence monitoring, as you say early preliminary data we have got is very reliable detection of recurrence and actually many months in fact the studies we showed we're out to the year ahead of clinical relapse we were detecting CTDNA relapse.

So we can already do that I think with a high degree of precision and accuracy. So it's something to look at. In terms of comparative studies these are notoriously difficult. And in time, we'll see these as more tests come through today, we're still validating the independent tests at some point they will come.

And of course, in the meantime, you will bet sort of more, cross trial comparisons where there are equivalent patient populations, or studies that it will enable some of those comparisons to be made. But I think we're probably some time off before we did fully completed head to head studies.

And part of the reason is in this setting these studies as a prospective study are very long duration. So they take a long time to do. So even starting today would be a number of years before they read out..

Okay, thanks for that question Derek and Clive hopefully that answered it..

Yes, thank you..

Okay. Well, thanks for all the great questions. We'll take one more question. Apologies for running a little bit over. But we'll take one more question and then wrap up..

Thank you. Our final question today will be coming from Andrew Cooper at Raymond James. Your line is live. .

Hi Andrew..

Hey everyone. Thanks for sneaking me here at the end, a lots been asked. But maybe just one we talked about it a little bit before but when we think about the pathway for RaDaR partnering with Agendia certainly seems to be a focus.

But I guess as we think about where you focus your efforts from prospective data generation and things like that and especially as we think about pharma layering, and as well what are some of the indications that you feel like should bump to the top of the priority stack? And how do we think about again, just kind of comparing where some of the others have started.

Do you want to be a fast follower there with a good assay or would you rather carve out in _ in some cancers that maybe there's less data from the competitors first. Just thinking about sort of the ordering and stacking of indications..

Yes. I'm not sure I can answer that in a very short, succinct way other than _ all of those things you allude to are possible. So very clearly there are some assays already in the market colorectal cancer, for example.

So, clearly, we would not be first if we entered that, but we believe we could be a fast follower, and based on the profile we see we think we could still be compelling. And that market is still very nascent. So we're still developing, and we think there is good opportunity of a fast follower.

We also believe that leading in certain indications is also possible. And we are exploring a number of indications where that may well be the case.

We think certainly the high levels of sensitivity that we see may open up some indications that may be more difficult for others and the last part I would say is the nature of a personalized essay versus if you like, an epigenetic based essay, the last question means we can be somewhat tumor agnostic. So clearly we need to develop the data.

We clearly need to look at the utility and the value proposition in any indication. We're able to take the same essay into different tumor types. And that's certainly the strategy we are pursuing. So expect to see a mix of fast follower in some and some where we may be leading..

So thanks, again, to everybody for the great questions. I'd like to end actually, probably with the most important thing I need to say, the incredible work that our 1900 NeoGenomics team members around the world are doing on behalf of cancer patients.

As I've been through the labs, and that were two people on video calls and around our site is, as I said earlier, I'm just so impressed with their commitment. Every NeoGenomics employee really carries cancer patients in their heart and the passion that they bring in the commitment is really taking my breath away. So thanks to all my colleagues.

Really appreciate it. Thanks everybody..

Thank you. Ladies and gentlemen this does conclude today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation..