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

Well, thank you, Holly, and good morning, everyone. I'd like to welcome everyone to NeoGenomics' First Quarter 2021 Conference Call. We have a lot of exciting news to share today, but first, let me introduce my fellow team members on the call.

Joining me this morning from our Fort Myers headquarters are Mark Mallon, our new Chief Executive Officer; Kathryn McKenzie, our Chief Financial Officer; George Cardoza, President of our Pharma Services Division; Bill Bonello, President of our Informatics Division; Doug Brown, our Chief Strategy and Corporate Development Officer; and Charlie Eidson, our Manager of Investor Relations.

Also joining us this morning via phone from the United Kingdom is Inivata CEO, Dr. Clive Morris. Before we begin our prepared remarks, Charlie will read the standard language about forward-looking statements..

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. As a reminder, this call is being webcast live and recorded, and we will be referencing a slide presentation in conjunction with our remarks.

Because there is a short delay between the live telephone audio and the presentation being shown on the webcast, for the best experience, please use either the webcast for both the audio and video content. Or if you dialed in by telephone, download the slides from our website and advance them yourselves.

To access the webcast, please visit the Events section in the Investor Relations section of our website, and a replay of the event will be available following the call.

Before turning the call back to Doug, 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].

the acquisition of Inivata and Mark Mallon's first conference call as the new CEO of NeoGenomics. Mark started a few weeks ago, and the company has transitioned to Mark's capable leadership. We'll begin our call by discussing our acquisition of Inivata.

I will review our strategic rationale for acquiring Inivata; and Clive Morris, Inivata's CEO, will follow with a more in-depth commentary. Doug Brown will then share details on both the acquisition and the strategic financing we announced this morning as well.

Kathryn will then provide an overview of our quarter 1 financial results and share some expectations about the impact of the Inivata acquisition. We will then transition to Mark Mallon to wrap up our formal remarks. Mark is excited to share some observations about his first few weeks leading NeoGenomics and his vision for the future of our company.

We will then have time for questions and answers. We are very excited about today's announcement. The acquisition of Inivata represents an important strategic move as we continue to position the company to achieve our vision to become the world's leading oncology testing and information company.

Channel leadership, combined with technology aggregation, can be a powerful dynamic. The combination of Inivata's best-in-class technology and NeoGenomics' unrivaled scale and access into the community oncology channel fortifies our already strong competitive position in oncology diagnostics, and allows us to accelerate our growth trajectory.

Bolstering our comprehensive test menu with the addition of Inivata's leading liquid biopsy technology for detecting circulating tumor DNA will allow NeoGenomics to provide testing solutions to our physicians and their patients for diagnosis, prognosis, therapy selection and now also for post-intervention detection of residual disease and for recurrence monitoring.

We also have greater opportunity to partner with our pharma clients as they develop therapies targeted to patients with residual disease and upon earlier detection of disease recurrence. We have spent the greater part of the year with the team at Inivata as their commercial and strategic partner and as an investor serving on their Board.

Now we are accelerating the exercise of our call option to combine our 2 organizations and bring more resource to Inivata's product development. We believe that much of the success of NeoGenomics is due to our culture and our focus on patients. Inivata shares this focus, and we have been impressed with the quality and cultural fit of the Inivata team.

Our common purpose is to save cancer patients' lives. We're convinced that we can accelerate the adoption of important diagnostic technologies for patients as part of the same organization.

Together, we provide physicians and pharma partners with an unparalleled spectrum of diagnostic tools to answer the broadest set of questions to diagnose and treat cancer patients and to develop new therapies.

Our Clinical Division's broad offering of approximately 750 tests has resonated most with community physicians where greater than 80% of cancer patients are treated.

Our Pharma Division's unique and extensive test and technology offering has clearly resonated in the market as we have now worked with numerous clients, including each of the top 25 largest biopharma companies in the world.

Clearly, our ability to serve our customers is strengthened with the addition of Inivata's liquid biopsy technology and positions us for continued broad testing leadership in oncology diagnostics.

Liquid biopsy is an emerging diagnostic technology that over time has the potential to change how patients around the world are diagnosed and treated for their cancer. Acquiring Inivata positions us for leadership in this exciting new area of oncology diagnostics as it continues to develop.

Community oncologists and pathologists are just beginning to use liquid biopsies in their practices, and we expect utilization to grow significantly with emerging standards in the practice of medicine. Perhaps the most exciting as an application of Inivata's ctDNA technology is the detection of minimal residual disease and monitoring for recurrence.

We are particularly excited about the opportunity to develop and commercialize Inivata's highly sensitive product, branded RaDaR, to address this important patient need in a market which some estimate to be in excess of $15 billion in the U.S. alone.

As shown on Slide 4, and as many of you know, we have built our company through both organic and inorganic growth and have a history of successful execution and integration of our acquisitions.

To achieve a leadership position in the market over the last several years, we acquired 2 important competitors in Clarient and Genoptix, adding very important scale to our business. Leveraging our scale in the clinical oncology market, we then successfully built out synergistic and complementary Pharma Services and Informatics businesses.

These 3 business units each have double-digit growth profiles, and the combination has created a flywheel for our company's future organic growth.

We believe Inivata, soon to be our fourth business unit, represents the continued acceleration of our strategy as we execute on our formula for oncology leadership and as the market for MRD develops, we believe our long-term growth will accelerate above historical levels.

As I was leaving my office in Aliso Viejo, California for the last time a few days ago, I found an old investor presentation from around the time we acquired Clarient in early 2016.

At that time, we described our plan to build on a solid core through innovation and business development, including a focus on pharma clinical trials, companion diagnostics, next-generation sequencing and liquid biopsy. It's exactly 5 years since we presented that to investors, and we did what we said we would do and more.

And now our company's growth profile is better than ever, with greater opportunities ahead. Most importantly, we increasingly have the potential to revolutionize oncology care to benefit millions of patients as they manage through their cancer journey.

With that, I would like to introduce Inivata's CEO, Clive Morris, who can walk through the Inivata story. Clive has an impressive background with expertise in oncology and as a practicing physician, in R&D and medical affairs within the global pharma industry, and in his years spent at Inivata, leading the developmental success of the company..

Thank you, Doug. Good morning, everyone. It's a pleasure to represent Inivata on the call today. And I'd echo Doug's commentary on the cultural fit between Inivata and NeoGenomics. We're all very excited about the combination.

Our proprietary liquid biopsy platform was spun out from the University of Cambridge in the U.K., and we have so far developed 2 leading assays. The company has been well supported by leading life science investors in the U.K. and in the U.S. And today, we have a talented team of about 90 people across an R&D facility in Cambridge, U.K.

and a CAP/CLIA laboratory in Research Triangle Park, North Carolina. We believe that by combining our leading technology with a well-capitalized and established oncology commercial engine like NeoGenomics will accelerate our mission to deliver our highly sensitive liquid biopsy products to the millions of cancer patients in both the U.K.

-- sorry, the U.S. and around the world who need them. As an overview of the Inivata platform, please turn to Slide 5 in the presentation. As Doug mentioned, we have developed a liquid biopsy technology platform that is optimized to achieve the best-in-class sensitivity levels across multiple applications.

We've developed 2 commercial stage assays, InVisionFirst-Lung and RaDaR, and we'll also bring new and complementary R&D, regulatory and reimbursement capabilities to NeoGenomics. InVisionFirst-Lung is a 37-gene liquid biopsy next-generation sequencing panel developed for patients with advanced non-small cell lung cancer.

The test has been commercialized in the U.S. with NeoGenomics since mid of last year, and the uptake is growing steadily as community oncologists grow more comfortable with liquid biopsy testing.

Importantly, the feedback from oncologists on the quality of the test, the service levels and the turnaround time of 7 calendar days from blood draw to results have all been positive. The test is reimbursed by Medicare at $3,500 per test.

And with commercial insurance coverage, the test has reimbursement coverage for approximately 200 million lives in the U.S. Our second commercial assay is RaDaR. This is a tumor-informed assay for residual disease and recurrence testing and has pan-cancer applicability.

The test was CAP/CLIA validated in our North Carolina facility in December of 2020, and the test received breakthrough device designation from the FDA earlier this year. RaDaR has been optimized to maximize sensitivity. Now on Slide 6, you can see why this is so important. The levels of circulating tumor DNA in early-stage cancer are very low.

And in the post-surgical MRD setting, they're even lower. Sensitivity is therefore crucial to success in this setting, and RaDaR has been specifically designed to provide this. We track 48 known genetic variants from the patient's cancer to achieve this.

But an equally important driver of our exquisite sensitivity compared to competitor platform is our core InVision technology and proprietary bioinformatics pipeline. We believe the combination of these factors drives great performance and that these advantages will shine through in our clinical study performance.

Slide 7 shows data from some recently published and presented studies for RaDaR versus 2 assays from well-known leaders in the minimal residual disease testing landscape. RaDaR's market-leading sensitivity down to 0.001% variant allele frequency allows the assay to pick up evidence of the recurrent -- of cancer recurrence very early.

The data on the slide is in lung and breast cancer, but we expect to be able to apply the technology equally into other solid tumors as well.

While the published clinical data and high levels of sensitivity for RaDaR are compelling, perhaps the most exciting aspect about RaDaR and MRD testing in general is the paradigm shifting impact it can have for patients along their cancer journey.

Slide 8 shows a typical clinical journey for a solid tumor patient and the potential use cases for test like RaDaR for MRD testing.

In the adjuvant post-surgery setting, RaDaR can potentially be used to help select patients for adjuvant therapy based on the presence of residual circulating tumor DNA in the blood, indicating that the patient has not been cured by their surgery. In the future, the test may also be able to help optimize the dosing or duration of therapy.

RaDaR testing can also be used to monitor for disease recurrence for cancer patients that are in remission. As shown on the earlier slide, molecular-level MRD testing with a test as sensitive as RaDaR has the ability to detect disease recurrence well before it would be identified by the current standards of care featured imaging.

By catching the recurrence of cancer earlier, we believe that action may be taken earlier, potentially improving the clinical outcomes for patients. Overall, we believe we're in the very early stages of a massive market being developed for MRD testing.

On Slide 9, you can see that in the United States alone, there are more than 1 million new cancer patients being diagnosed every year, and these may benefit from MRD testing. Even using conservative assumptions around MRD test utilization and pricing, we believe this translates into an estimated market opportunity of $15 billion or more.

And given over 80% of the cancer market is in the community setting, we expect that the majority of this market will develop where NeoGenomics has a leading market share. While the clinical market is in its very early stages of development, biopharma is highly interested in the application for MRD today.

MRD testing post-operatively has the potential to revolutionize the way early-stage oncology adjuvant clinical trials are conducted and the ability to quickly determine responses to therapy in clinical trials is appealing to patients and biopharma alike.

Clearly, the potential for MRD is immense, and we have a detailed plan to become a major player in these markets. On Slide 10, we outlined some of the key milestones for RaDaR.

We are already collaborating with pharma following our CAP/CLIA lab validation completed in December, and we recently unveiled strong data in breast cancer and head and neck cancer at April's AACR conference, and we anticipate additional clinical data at ASCO in early June.

We believe we'll be in a position to submit data through the MolDx pathway for reimbursement around the turn of the year, which should allow us to commercialize in the clinical market in mid-2022, assuming 6 months review process.

I will now turn it over to Doug Brown, who will provide a summary of the deal terms of the acquisition as well as details of the strategic financing that was announced this morning..

Thank you, Clive. Good morning. On Slide 11, we are pleased to formally share with you the terms of the Inivata acquisition, terms we agreed to with Inivata as part of our commercial partnership agreement we negotiated over a year ago during the first few weeks of the pandemic.

As part of that agreement formed with Inivata last year, we announced we would be making a $25 million minority investment in the company, that we would commercialize InVisionFirst-Lung liquid biopsy in the U.S. and we announced that we negotiated a fixed price call option to purchase the remaining equity of Inivata.

But until today, we had not shared the acquisition price of $390 million for our remaining interest.

Valuations for highly advanced and proprietary liquid biopsy platforms like Inivata's have increased substantially since we struck our deal in May of 2020, and we feel very fortunate with our timing and our ability to deliver what now appears to be a value-based technology acquisition for our shareholders.

The date for the expiration of our purchase option was set for December 31, 2021. Over the past 12 months, we have continued to gain confidence in the power and sensitivity of the Inivata liquid biopsy technology. We have also developed tremendous confidence in the talented team at Inivata.

As a result, we are exercising our option to purchase Inivata 8 months ahead of plan. We are confident that this important strategic move is the right one. And in conjunction with today's acquisition announcement, we are pleased to also announce a private financing of $200 million.

We view this financing as a strategic capital raise, which is represented by a syndicate of over a dozen targeted investors, including existing Inivata shareholders, existing NeoGenomics shareholders and, importantly, new specialist investors with a focus on oncology.

We are pleased to have attracted the leading investors who support the combination of channel and technology leadership. Pro forma for today's transaction, our balance sheet is quite strong.

We have greater than $550 million of cash on hand, providing ample flexibility to accelerate funding of technology development at Inivata while we pursue further strategic opportunities. I will now turn the call over to Kathryn McKenzie to discuss some of the other details of our quarter 1 financial results..

Thank you, Doug. Despite the impact of the ongoing pandemic, total revenue in Q1 grew 9% year-over-year to $116 million. Importantly, our core oncology revenues increased 7% year-over-year, driven by strong growth in NGS, Pharma Services and Informatics.

COVID-19 PCR testing contributed less than $2 million of revenue during the quarter, down from $9 million in quarter 4 and $17 million in quarter 3. We noted a significant decrease in demand for our COVID-19 overflow testing capacity and therefore made the decision to wind down our COVID-19 testing capabilities.

As a reminder, we brought up COVID testing to help address the shortage of U.S. capacity and expected this service to be short term in nature and not part of our overall strategy as a leader in oncology testing.

As we discussed on our February earnings call, our core clinical cancer volumes were noticeably impacted by the COVID-19 incidence in January and February. However, our core volume showed meaningful signs of recovery in March as record daily clinical volumes translated to 19% growth versus March 2020.

Despite the challenging start to the quarter, we delivered 4% volume growth over Q1 2020. Importantly, this strength continued into April with record daily volumes and we are very encouraged that we will remain on a steady recovery as vaccine rollouts continue and COVID-19 incidence rates decline.

Finally, we were pleased to see that Clinical Division revenue per test was $364 compared to $363 for the full year of 2020. While we are encouraged, it is also worth noting that we are not all the way back to a full recovery.

We continue to see a contrast in volume growth for our business from areas of the country that are less restricted versus those with more restrictions. And we believe this bodes well for us as restrictions loosen nationwide over the course of 2021. Pharma Services grew 46% year-over-year, continuing its rapid growth trajectory.

As a reminder, last year's acquisition of the oncology assets of HLI closed on January 10, 2020, so this growth is essentially all organic. Not only did revenue conversion improve for this business in Q1, but demand continues to be very strong.

We signed $31 million in new bookings during the quarter, exiting the quarter with a record $218 million in backlog. We continue to grow our robust portfolio of biopharma customers and believe that Pharma Services is better positioned than ever before and poised for additional rapid growth ahead.

We have also rapidly integrated the Trapelo Health organization into our Informatics Division. We are already leveraging our commercial capabilities to reach more customers while we leverage our IT capabilities to further strengthen an already leading decision support tool for oncologists. More to come on Trapelo in the second half of the year.

Our gross margins were challenged in Q1, particularly in January and February, due to less efficiency on lower volumes. We have been challenged by the volatility in volume over the last year, including during the first quarter.

However, we continue to believe that our decisions to invest in our infrastructure are positioning us well to take share as volume returns. Q1 gross margins were also impacted significantly by our decision to wind down our COVID-19 overflow laboratory, which resulted in a $5.3 million charge related to unused COVID-19 testing inventory.

Clinical gross margin in Q1 was 36.2% when including COVID-19 exit charges and 41.7%, excluding these charges. As we return to more consistent growth rates and a normalized economic environment, we expect to yield gross margins in line with historical rates, with continued long-term margin expansion opportunity over time.

In Q1, we grew Pharma Services revenues by 46% year-over-year or $6 million, with COGS only increasing by 15% or $1.7 million over that same period. Pharma Services gross margins improved from 17.7% in Q1 of 2020 to 34.9% in Q1 2021.

Operating expenses increased $5 million year-over-year to $57 million and includes investment in and support for Informatics, payroll and payroll-related costs, acquisition costs and a write-off for COVID-19 PCR testing laboratory equipment.

Adjusted EBITDA of $4 million in Q1 reflects lower gross margin on clinical volume volatility, as previously discussed as well as continued investment in key initiatives, including our people, infrastructure and strategic growth areas such as Informatics.

Excluding our recently announced acquisitions, we expect our organic EBITDA contribution to increase in each of the succeeding 3 quarters of 2021. Turning to the balance sheet.

We exited quarter 1 with $803 million in cash and marketable securities, which excludes an additional $11 million in restricted cash designated for construction of our new state-of-the-art laboratory and global headquarters in Fort Myers, Florida.

Subsequent to the end of the quarter, we utilized $35 million in cash for the acquisition of Trapelo Health, which closed in April. Following the acquisition of Inivata and incorporating the funds raised in the strategic financing announced today, we expect our cash balance to be in excess of $550 million.

We believe this puts us in a strong position to continue to invest in these recently announced acquisitions and internal strategic priorities as well as pursue inorganic growth opportunities. Given the positive trends in our business and the vaccine progress being made across the country, we are prepared to introduce full year 2021 guidance.

We expect consolidated revenue to be in the range of $490 million to $510 million. Presuming no further market dislocations from the COVID-19 pandemic, our top line growth for full year 2021 will be driven by Pharma Services' annual growth in excess of 35% and by what we anticipate to be a very strong back half of the year for the entire business.

We project that our back half revenue run rate could be in excess of $525 million. Pro forma for the Inivata and Trapelo acquisitions, full year adjusted EBITDA for 2021 is expected to be in the range of $10 million to $15 million.

We anticipate approximately $30 million in 2021 operating losses to fund the development of RaDaR, accelerate submission of RaDaR for reimbursement and to further support the development and rollout of the Trapelo clinical decision support tool and related offerings.

We are very excited about both of our recently announced acquisitions,and the innovation they will provide to clinicians, pharma partners and most importantly, patients. However, for 2021, we do not expect a material amount of revenue from these transactions.

Particularly for MRD, while the markets are evolving rapidly, we are still in the early stages, and RaDaR is not expected to become a material portion of NeoGenomics revenue until 2023 and 2024. These acquisitions are changing the near-term profitability profile at NeoGenomics.

However, we believe that investing in the future of oncology is the right strategic move. I will now turn the call back over to Doug VanOort..

Well, thank you, Kathryn. We certainly have a lot to be excited about at our company and with Inivata, the recent acquisition of Trapelo Health and the addition of Mark Mallon as our CEO. Mark Mallon is a very talented executive with a wealth of experience and a broad skill set.

We interviewed an exhaustive list of capable leaders, and we feel fortunate that we were able to recruit someone of Mark's caliber. I'd like now to formally introduce Mark to many of you for the very first time..

Thanks, Doug, and thank you to the entire Neo team for the warm and enthusiastic welcome. I joined Neo because I was inspired by its mission to make a major difference in the lives of cancer patients and because I was impressed by the incredible talent and passion of its value-driven people.

I clearly saw the opportunity for Neo to become the leading cancer testing and information company in the world. Two weeks into the role, I can say my expectations have already been exceeded. I've had a chance to visit our major labs in Florida and California, and I can see why Neo is known for excellence in quality and customer service.

We have fantastic teams urgently working on behalf of patients. I've been able to review the plans of all 3 divisions, and I see opportunities to accelerate growth in each of these businesses.

I spent a day with our R&D team and was excited by the science I saw, both in terms of future assays and the opportunities to improve our quality and efficiency through automation. Finally, I'm already engaging with key stakeholders, especially our customers and our investors to make sure I'm clear on their expectations for Neo going forward.

The focus of my first 90 days will continue to be to learn about this great company and the opportunities ahead and to ensure the organization is focused on the key drivers of growth. In the Clinical Division, I'll be especially focused on our incredible portfolio of NGS assays, including our liquid biopsy tests.

This portion of the business is already growing more than 30% annually, and I think there are opportunities to accelerate growth further. I also believe there are multiple opportunities to simplify and automate our processes while we ensure the successful launch of our new laboratory in Fort Myers.

In the fast-growing Pharma Services Division, we've only just started opening up the business beyond the U.S. We have an excellent newly staffed global sales team and outstanding labs in Europe and Asia ready to meet the high demand of our customers for testing in these growth markets.

In Informatics, we'll be laser-focused on making Trapelo the decision support platform for oncologists, ensuring we have the right capabilities in this platform and a rapid rollout, starting with our existing customers. Finally, I am very excited about the announcement today to acquire Inivata.

Inivata will remain a separate business unit, with Clyde Morris as the President reporting directly to me. I'll be working with Clive and his entire Inivata team to ensure we meet or exceed our time lines for gaining MolDx approval and launching RaDaR into our first opportunity areas.

I believe RaDaR represents an opportunity to build a leading franchise for Neo in the MRD market. There is no time to lose. Cancer patients and physicians who care for them continue to desperately need faster, better diagnostic results and insights.

I'm confident that Neo, in meeting these needs, will become the leading global cancer testing and information company. Charlie, back to you..

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

Incidentally, 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 charlie.eidson@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..

[Operator Instructions] Your first question for today is coming from Puneet Souda..

Puneet here from SVB Leerink. So Mark, first of all, congrats and great to have you on board. And Doug, we'll miss working with you for sure. Maybe my first question is actually on MRD. Clearly, an important acquisition for the company. Wanted to get your view in terms of where the market is.

This is definitely an early entrance for NeoGenomics into a market traditionally have taken a more measured approach in which you were entering when the market is getting closer to the community setting.

Maybe just talk to us about what are you seeing in the community setting where you're serving a number of oncologists and the expectation for sort of penetration there with the RaDaR and with these other assays, including InVision Lung? And if you could also provide a view into what would you do with the Neo lab assay.

Is that going to be part of the overall liquid franchise? And then lastly on MRD, if you can also provide in terms of what are the types of clinical trials, both in adjuvant and new adjuvant setting that you are working on and what sort of data we should expect here? Any indications that you can provide there would be helpful..

Okay. Puneet, thank you very much for the question. We'll try to answer those and ask a few of our teammates to weigh in. First of all, we do have 2 liquid biopsies we currently have in the marketplace.

One is the Inivata InVisionFirst-Lung assay and the other is the Neo lab assay, and both are gaining traction in the marketplace as we enter the community setting.

But in terms of the MRD market penetration, Mark, why don't we turn that over to you?.

So great question. I think there's a couple of reasons that it makes sense for us to move now. So first of all, we -- in the community setting, of course, I think we have to be realistic. This will be a gradual uptake.

But we're already seeing an increasing adoption of liquid biopsy and we're leading the way, and we are building the capabilities to be able to do that. And so we think as we bring MRD on board in '22 and beyond, we'll be in a really great position to be part of that acceleration and get in early.

I think the second important point has been the growth of our Pharma Services business. This is a tremendous asset for pharmaceutical companies, and that is going to be something that also will accelerate the advancement of the MRD category. And as you've just heard, we are already working with the top 25 pharmaceutical companies.

And I think combining Inivata's capabilities with our capabilities will allow us to penetrate that market really, really quickly. And I think the last thing I want to highlight is Trapelo and what that can mean for us when we put that together with our leading position in the clinical and with RaDaR.

One of the things that I think is going to be critical to getting community oncologists is support from making decisions on using the increasing number of tools.

And the whole point, and what's so exciting about Trapelo, is that too is exactly designed just to do that, is to help oncologists make the right choices as they're dealing with now an increasing array of solutions. So I think we've got sort of all the pieces coming together to make this a success and we're already strong in oncology.

Now still, we have to be realistic. There'll be a gradual growth in this, but we want to get on the ground floor. And I think we're ready to do it for those key reasons. And I think there was a question, Doug, about the market potential.

Is that maybe something for Clive to talk about?.

Yes. Clive, if you would please address the question that Puneet asked about clinical trials and how you see MRD in the pharma space..

Yes. Thanks for the question, Puneet. As we mentioned through the assay underwent CAP/CLIA validation and concluded that in December of last year. So now we're clearly moving from the analytical side into the clinical trials. We presented some early data from head and neck and breast cancer at the AACR virtual meeting recently.

One of those was an archival cohort, and one was an ongoing prospective study, and we will have data, an update to our lung cancer cohort, the LUCID study that we initially presented preliminary data on last year. We'll be updating that with more complete data at the ASCO virtual meeting in early June.

Having completed the validation work, as I say, we are now getting into increasing numbers of prospective studies as well as further retrospective studies to use, historical data sets where they exist. And they're across a number of different settings.

So we have a number of academic collaborations and also the biopharma partnerships as well, and we span multiple different tumor types.

And so I think you could expect to see sort of in the future, additional biopharma relationship being announced as well as data coming out from a suite of initial data will be from retrospective data sets, of course, but then increasingly as the prospective studies set up and then run through a report data to see those coming through.

So expect to see those multiple different tumor types from across different collaborative type of arrangements..

Got it. That's very helpful. And if I could just briefly touch on, Mark, as you look at -- I know it's a little bit early still, but as you look at the organization, where are some of the most interesting opportunities? Obviously, you highlighted some of the NGS and MRD with the acquisitions there.

Where do you see opportunity? And coming from some of the pharma background, how do you see -- from your vantage point, how do you see this market shaping up? And also, if I could ask on -- there was an update on Dr. Weiss' departure this morning.

I just wanted to get a sense on what's the plan there in terms of pursuing for the next CSO and getting someone into the seat..

So Puneet, I will say, for me, the biggest opportunity is one I highlighted initially, which is I think we've got a great set of NGS and liquid biopsy assays that have had success and already growing faster than 30%, but I think we can do more.

And the key is actually applying some of the lesson from pharma and from actually the oncotechs, where we're going to be starting to add new services to support the uptake of these products, whether it's as simple as something like a mobile for battery for the liquid biopsy or reimbursement support.

These are a number of capabilities that are new to Neo. And we -- I think we can accelerate those. I think you've got to have increased sort of focus in marketing. You've got to have an increased focus on data generation. An example, again, Neo was already moving in that direction.

We've got a -- we're going to be adding a small sales force basically focused on precision medicine to specifically focus on next-generation sequencing products and liquid biopsy. And so those types of tactics that pharma has massive -- that I'm already working with the team.

They've already started working on this, but I think we can accelerate that further. And this will apply in other parts of the business. And happy to look forward to talking more about that -- the other opportunities I mentioned earlier. Maybe Doug should talk about Dr. Weiss..

Yes. Thanks, Puneet, for the question about Dr. Weiss. We're grateful to have had Dr. Weiss as our Chief Medical Officer and then as part of our company, he became part of NeoGenomics through the Clarient acquisition a number of years ago and has served as our Chief Medical Officer. And Dr.

Weiss, for those of you who didn't see, we announced this morning has resigned to pursue other interests. I would like to make a point here. We have, in our company, about 120 MDs and PhDs all focused in oncology. So we have a very deep bench strength. We have very capable medical directors and leaders in our company.

Now with the addition of Inivata, we're bringing in a whole new type of technology and R&D leadership in addition to the leadership in R&D and in medical that we had here already. So we're very excited about the team that we have.

We're very excited about the new people that are joining NeoGenomics from the Inivata acquisition, and we're very excited about our team going forward..

Your next question is coming from David Westenberg..

This is David Westenberg from Guggenheim Securities. I'll ask my 2 upfront. First, Slide 10 is great.

Can you maybe walk us through this a little bit more in terms of you're going right to the FDA, you do want to get this FDA approved and can you just confirm that? Would you pursue a clear strategy? And when you say expected to be a significant component of revenue, can you give us a flavor in terms of -- or maybe even a little bit of a guide rails on what exactly significant revenue means? So if you can help us just maybe fill in the blanks.

Again, it's a great slide in Slide 10, but just those time frames are helpful. And then also in terms of I didn't hear a close date. Maybe I'm crazy, I keyword searched close in terms of if this is closed now or if it's expected to close in the future. Second question is on Inivata and potential presentations for ASCO and AACR.

Can you give us any data or any kind of flavor on presentations you might have? And then in terms of the pharma business, would you incorporate -- what would you incorporate of Inivata's products into that pharmacy business? And I'm stopping there. There's obviously a lot of analysts on the call that need to ask questions..

All right, David. Well, thank you for those questions. I'll take the easy one. The close date for Inivata should be around mid-June. We've got to go through the typical regulatory approvals. In terms of FDA milestones and time frames, I'll turn that over to Clive and ask him to address that question..

Thanks, Doug, and I'm happy to. Good question, David. Relative -- think of this as a parallel track type of activity. So the assay is CAP/CLIA validated now, generating data. And as the slide says, we can then think of that through a MolDx submission and then start commercializing that as effectively as a lab development test at LDT for the U.S. market.

And the slide says anticipate that reimbursement next year and moving through the commercialization phases. However, the assay has been built to full design history and design control, et cetera, to enable an FDA path. And as we mentioned, we do have an FDA breakthrough device designation already.

So that's something we will look at in parallel and then bring that through. Some stage for that are probably longer through and it depends on chemical trials, of course, for leading that through the FDA.

And so it will be a sort of a, given you're familiar with the path taken by companies like financial mentioned by Guardant and others, and it's a similar approach to the overall 2 paths..

Thank you, Clive. And then, David, for your question about revenue, Kathryn will address that..

Yes. So David, the revenue is still very early for Inivata. There are some pharma opportunity that exists today, albeit it's still very minimal compared to NeoGenomics' total revenue. And the clinical is very much in the early stages. For 2021, we're expecting less than $5 million in revenue, primarily driven by InVisionFirst-Lung.

So as we're going through the time line that Clive just mentioned, we're looking at the overall market opportunity as well as the time line that it will likely take for that really clinical oncology adoption. And that's what we're saying it's going to come later on 2023, 2024. I would expect double digits in 2023, if not higher.

And then really, we're looking at how that can grow over time. Definitely as we get into 2024, I think that there's significant opportunity for that to grow on an accelerated pace as MRD really gets through more of the development and acceptance into the core oncology market and community setting..

Great. And David, I think Clive mentioned that there are ongoing retrospective and prospective trials for RaDaR across multiple tumor types. And you should expect to see more presentations and publications as we go forward through the development of the RaDaR product.

Clive, I wonder if you could also comment on David's question relative to pharma collaborations..

Yes. So a number of collaborations ongoing. And as I say, they span a number of different areas. So of course, there are opportunities with InVisionFirst as a more of a patient selection type of opportunity. And then for RaDaR, we really see 2 different areas and certainly patient selection for adjuvant clinical trials.

We think that's a huge opportunity. For those familiar with the space know very large, very long, very expensive trials because many of the patients in those trials are cured. And then the treatment effects are diluted out by those patients who don't benefit.

And of course, applying a test like RaDaR enables you to select patients who have known disease so your trials can be smaller, more rapid and you get the full benefit of your treatment effect. So that's a really good opportunity and then simply for early detection of response.

So using this as a, if you like, a surrogate marker of response to therapeutics so you can get an early read on efficacy. So we're seeing traction for both of those types of studies. And of course, longer term, there's potential for DNA, ctDNA sort of detection of recurrence, for example, become a surrogate end point.

And so why that's clearly a longer-term aspect. So we're pursuing all of these with quite a range of different pharma partners across a range of different tumor types..

Your next question is coming from Alex Nowak..

This is Alex from Craig-Hallum. You mentioned cancer screen rates are improving throughout the quarter.

So going from March into April and now May, where is cancer testing volume going in real time as states reopen? And I guess, what are you building into the guidance as far as the recovery goes?.

Yes. Thanks for the question, Alex. So what we saw throughout Q1 was clearly depressed volumes in January and February, not only from COVID, but also from weather impact in February. We saw a significant increase in March and April. We wanted to see the continued increase past March, which was very encouraging.

And again, into May and now we're only a couple of days in, but that trend is continuing. So building into the guidance of continued rebound in the clinical volumes as well as continued revenue recognition on pharma backlog and continued growth there.

So we do expect that it's going to strengthen throughout the year, albeit I don't expect the acceleration to be as strong as it was in February to March, but we're seeing really good indicators as the economy is opening and COVID-19 rates are going down that we're returning to a more normalized growth rate..

Now that's great. And then maybe expand on the decision support tool.

I know you want to speak on it later this year, but can you just help frame the picture on what do you see in that tool? How is it going to be used in practice with oncology? And is it fair to say that, that tool is going to help increase the stickiness of Neo's business and then ultimately the number of tests ordered per requisition?.

Yes. Alex, we have integrated and are integrating now the Trapelo Health acquisition as part of our Informatics Division. And Bill Bonello is here, and he'll address your question..

Thanks a lot for the question, Alex. We are very excited about the Trapelo opportunity.

So what Trapelo has built is a precision oncology knowledge system and a clinical decision support system that helps support oncologists as they make decisions that what are the appropriate molecular tests that they should be ordering for solid tumor cancers, and then on the flip side as they're trying to determine which therapies are most appropriate to utilize.

And the information that Trapelo provides is all based on exhaustive combing of up-to-date clinical studies as well as incorporating a variety of different oncology guidelines.

And so based on that information, which Trapelo has curated, they then make a series of recommendations to the oncologists or at least guide them towards what is evidence supported. We will be incorporating that tool into what we do at NeoGenomics, and we will make it available to our practicing physicians when they tap into our online orders.

But we will also keep the tool available as a freestanding lab-agnostic tool so that oncologists and pathologists can use this even when they're not ordering from NeoGenomics. The other very important component of the Trapelo solution is working with payers.

We have the capability to provide something that we're referring to today as fast path, which basically helps the oncologist and the laboratory facilitate the prior authorization process.

And so when they go into the clinical decision support tool, they can see which particular test, at which particular laboratories are most likely to be approved by the payer and know that all of the supporting information to get prior authorization will be provided automatically through the Trapelo system.

So we think this actually has an opportunity to sort of revolutionize the way that prior authorization and utilization management works for both testing and therapy in the market. And yes, we absolutely think it will drive stickiness for NeoGenomics as well..

Your next question is coming from Brian Weinstein..

Brian Weinstein from Blair. I guess just a high-level one here to start with. And that is really around the use of comprehensive genomic profiling for therapy selection is still not in place widely. There's a lot of people going after that, obviously, and a lot of companies are doing well.

But when we look at patients, they're still not, for the most part, getting comprehensive genomic profiling. And with MRD, we're talking either less so.

So I'm curious about what efforts you guys are planning to take to help advance broader awareness in use of these technologies, which now you have a much bigger vested interest in?.

Well, Brian, thank you for the question. First of all, we are -- with our pretty large sales team, we're constantly helping to educate the community, both pathologists and oncologists about the benefits of comprehensive genomic profiling, and that's something that we do.

We offer solutions to our physician clients as they think about new ways to treat patients with this emerging revolution that we're in, in terms of precision oncology.

I would say that the explanation that Bill just gave about Trapelo is also important because Trapelo is a tool that will help physicians understand what is the best test to order and the most medically appropriate test to order. So that's a very important component of this whole move to genomic profiling on a more comprehensive basis.

And we think that, that will also help us as we begin to commercialize the MRD product in the future..

And I'd just add one point on to that. I think those are 2 key, let's say, barriers to uptake or accelerators, depending on how you look at it, right? So there's the education and supporting decision-making and then there's also the addressing sort of the reimbursability and access.

And I think Neo already has capabilities to support both of those, Trapelo will add to that. The other third piece is we do have to continue to build the data support behind use of things like comprehensive genomic profiling and of course, the MRD. And that's where I think, obviously, the work Inivata is going to do.

And by having potentially the best-in-class assay, we're going to be aggressively, and are already are, positioning clinical work to expand the data to support that. And I think importantly, it's the partnerships with pharma where the real sweet spot is going to be.

And working with them together to generate the data that is going to support and give physicians more and more confidence to use this diagnostic because they're going to see that this is what you do to get to patients earlier with the right therapy.

And I think having the best-in-class asset with Neo is really growing incredibly, strong position with pharma is going to allow us to play a big role in shaping that next wave of data generation in partnership with the pharma industry..

Great. And then just a quick one for Kathryn. Did you say what the net impact was from Inivata and Trapelo on EBITDA this year? If you did, I missed it, and I'd appreciate if you could just let me know what that is..

Yes. We're estimating it to be about $30 million for both of them together..

Your next question is coming from Mark Massaro..

This is Mark from BTIG. I guess lots of news this morning. Mark, congrats on joining NeoGenomics. I guess you spent over 20 years in various leadership positions, wearing a lot of hats at AstraZeneca. As you know, of course, AZ is one of the leading adopters of MRD testing in clinical trials work.

So I guess, can you speak to any experience you might have had in MRD at AZ? And do you think you can leverage this experience to potentially work with AstraZeneca, recognizing that some other large companies like Natera and Archer are already working with AZ. So I'll stop there..

Right. So thanks for that question. My involvement with AZ on oncology was in the very early days of MRD trial. Didn't have a chance to work a lot on that during my time there.

But what I did have a chance to do, particularly leading the international organization and also working in global marketing is really think hard about how you bring new diagnostics to the markets and enable a launch of new therapeutics and to actually change the practice of care.

If you think about it, I was responsible for everything sort of outside of Japan and North America and EU when we were starting the early stages of launching Tagrisso and Lynparza. And we had to basically build out diagnostic networks country by country to enable really the adoption of those new therapeutics.

And I think if you look at the track record of AZ in those markets really due to the great teams that we have on the ground and their commitment to supporting diagnostics, we really made a lot of progress.

And I think that there's going to be a similar real need is that partnership with pharma and really excellent local on-the-ground diagnostic labs, which in the U.S. is Neo to bring that technology forward. So there's many things to go in it.

We can talk to some of the other factors, but that to me is one of the keys that made me so excited about Neo in putting together this MRD technology because the key really is that sort of interface with a great lab with physicians supported by the right sort of resources behind it..

Great. And my last question, obviously, congrats on the Inivata acquisition team. Seems like a reasonable, certainly a reasonable valuation. Maybe for Doug Brown or others, can you speak to other strategic intents? When you look at the M&A landscape at large, obviously, you guys have been acquisitive.

Can you just talk about the funnel and maybe comment about the valuation dynamics in the industry today?.

Thanks, Mark. It's Doug Brown here. And we're excited about Inivata, but we're not done. But we're going to integrate this for a little bit here. But things on our mind continue to be pharma and Informatics. And I do think the valuations are challenging. And so we really got lucky with striking this deal in May of last year.

And so that we continue to balance sort of our prudence and value and how we think about the M&A market with the valuations that are out there. So we're very pleased with what we announced today, but we're going to continue to look at opportunities in M&A..

Your next question is coming from Tejas Savant..

This is Tejas from Morgan Stanley. I have a few questions on Inivata for Clive perhaps.

Can you just walk us through your sort of big-picture philosophy on tumor-informed versus tumor-agnostic approaches to MRD? Obviously, you're pursuing a tumor-informed approach that comes with sort of perhaps limited detection advantages, although that's sort of up for debate as well.

But then on the other hand, you do have the longer turnaround time versus a tumor-agnostic approach. So just wanted to get your sort of philosophy on that. And then secondly, as it relates to commercialization, you've got a couple of competitors here, maybe even more coming to market in the next 6 months or so.

How do you think about accelerating those time lines? I know the PR mentioned the specialized NGS sales force. So perhaps you can -- if you can share some color on the sizing and the hiring cadence there, that will be helpful..

Great.

So Clive, would you please take the first part of Tejas' question around tumor-informed versus tumor-agnostic?.

Certainly, Doug. Thanks for the questions, Tejas. In short, when you think about what people are doing with tumor-informed or when people create a standard assay with multiomics or others, you're really trying to overcome the really big dilution of DNA in the blood. So the levels of circulating tumor DNA are very low.

As we've looked at this, we believe that combining, as I say, the technology and also the approaches we have with RaDaR gets us to exceptional levels of sensitivity and I think levels that have not been published or presented by any others to my awareness. You are right.

Theoretically, there is more complexity for the upfront test with having to do the whole exome sequencing, building the assay.

We think that is achievable within the window that normally occurs between surgery and then when patients are reviewed for potential adjuvant therapies or trials in the adjuvant setting, quite often is in the region of 4 weeks or so. And we think that is achievable for us.

And it's important to remember that once you formed the test, It is actually then a rapid turnaround time because you -- it's been the same as they need standard liquid biopsy. So our view is that's a 1-week turnaround test once the assay is created. So for recurrence monitoring, it's very compelling on the turnaround time.

I think ultimately, it will be informed by the data. So we're now building those clinical data sets we showed on one of the slides, the data, albeit from cross-trial comparisons with 2 competitors that are out there.

But as we look at this, we believe that tumor-informed strategy and the approach we have with RaDaR, the technology is, we think, is very compelling. And we'll see how that develops over time..

Great. Thanks, Clive.

And Mark, would you like to comment on the commercialization and where we stand there?.

Yes. So Tejas, what I can say, first of all, we are not going to leave any stone unturned in terms of making sure we maximize this opportunity. So we will make sure that we're able to be competitive from a commercial standpoint, medical payer standpoint and generating the data and the publications to support it.

And we're not ready to say what that number of sales reps. And I think actually, we can get overfocused on sort of the actual number of sales reps because I think what Neo was going to be able to bring, which are sort of 3 prongs to the rapid launch. So first of all, we do have our base.

We've got more than 100 sort of commercially focused roles and people, salespeople, but also the customer service-type support that has allowed Neo to be the leading company in the community oncology marketplace. And that platform is in place.

Basically, every customer that would be or a customer potentially for MRD is already ordering products regularly and even on a weekly basis from Neo. And we've got a fantastic commercial team driving that. I think we will have specialty resources internally. We're bringing that forward initially to support the InVision assets.

And we'll do the work over the next few months to figure out what the right size of that is when we bring in the MRD.

But then I also think with Inivata announcing that partnership, breast cancer is the third key aspect that we're going to be able to just again go faster and again, puts us in a little bit of a different category of only just sort of looking at what our -- the sales representatives we might have.

And that is leveraging people that already have a great position and a particular phenotype. It can take, I think, one of the things that slows uptake is having to sort of get new people into offices and building relations, building confidence in supporting the product.

And I think Neo has had a track record of really doing a great job in partnerships. And so I think we'll be looking to leverage that too as a model for going forward. So we'll have a 3-pronged approach. We're going to make sure we don't shortchange it. I'm confident we can be successful..

Got it. Super helpful. And a quick follow-up, Mark, while I have you. In the past, I mean, Doug has mentioned sort of NGS, Informatics and pharma essentially now being about 1/3 of NeoGenomics revenue.

Just philosophically, how do you see that mix evolving and over what time frame? Like what's a good target number for, say, 2025 for that mix in your mind? And one quick cleanup question for Kathryn as well.

Kathryn, can you help us quantify the weather-related headwind that you saw in February? Just trying to get a better sense of underlying revenue trends and exit momentum you're heading into the back half of the year?.

So I usually feel pretty confident in my forecasting ability. So 13 days in, I'm not ready to give a split of the business on 2025. What I do feel confident is the growth rates we have for all 3 businesses, I think we can do better. And so for sure, it's going to be a bigger share on both pharma and Informatics, a bigger share.

But the other thing I'm going to be really focusing on is what is the share of next-gen sequencing liquid biopsy of our clinical business. And that is a lever that I really want to focus on driving further. So you put those 3 pieces together, which I see is sort of the real new business, I think it could be a very substantial portion by 2025.

Just give me a little bit more time to work with the team to frame that with us. But yes, no question, it's going to be bigger. There's 3 pieces of the new business, and I think we can actually accelerate growth in all of those components. Sorry if I didn't give you the specifics you like, but that's how I'm thinking about it..

No problem, Mark. Understandable..

And then from the weather impact, we actually have one of the biggest supply chain disruptions I think we've ever had, and it was really unfortunate that we've already had COVID volatility to then add the weather on top of it.

We actually had several thousand samples that were held up for a good bit of time in February that had a couple of million dollar impact to February. We did see a lot of that volume come back in March. But that did impact our overall operations and how we work through it and our overall margins, both for January, February as well as March.

As we were working through that backlog, it's very challenging. But excluding that, we still saw the organic increase in March and in April. So we feel good that the volume we saw in March was not only the February samples coming in, but was also a return to that more organic growth..

I think we are going to have to wrap up this Q&A period now. We've gone a little longer than we typically do. So as we end the call, I'd like to recognize approximately 1,740 NeoGenomics team members around the world for their dedication and commitment to building a world-class oncology diagnostics and information company.

And on behalf of the whole team that's here with me today, I want to thank you for your time joining us this morning. And for those of you listening that are investors or are considering an investment in NeoGenomics, we thank you for your interest in our company. Thank you..

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