neogenomics investor relations
Jan 12 2021 4:42 AM

Maybe a bigger picture question on having a strategy in both Clinical Services and Pharma Services, I think companion diagnostics represents maybe a key synergy there. We also now are getting interested not only because we can help in Pharma Services with the companion program, but also because we have the ability in our clinical division once the therapy is approved by the regulatory agency to flip it over and to help commercialize that assay and the therapy is relatively rapidly, because we have the test up and running. Prior to joining NeoGenomics, Bill worked as a healthcare equity analyst covering diagnostic services and product stocks at Craig-Hallum and at a variety of firms, and was also Senior Vice President for Investor Relations at LabCorp. Okay. There is also an opportunity on the imaging front, there is significant interest in utilizing annotated digital images for training purposes and other research-related activities. Thank you for taking the question. Since that time, we have continually and systematically built this business to be competitively well positioned. That's great. We are not yet back to pre-COVID test volume levels in terms of what we expected. But right now, we had to separate from our clinical division, we just grew to the point where our projects were so large, we had to build our own infrastructure, so that depressed our margins in the short run, but certainly we expect to grow into the capacity we have. Doug will review some of our other strategic areas of investment. Kathryn B. McKenzie-- Chief Financial Officer. We've got another dynamic frankly and that's that we're doing, I think, a better job of collecting for the work that we do and that impacts AUP also. So long-term, we've said that we expect them to get around the 50% margin where clinical was and certainly we're still anticipating that if we can fill up our capacity. In our core oncology business, revenue grew 28% sequentially and 4% year-over-year. And then, just maybe a question for Doug Brown. Part of that process, by the way includes whole exome sequencing that we -- we're working with them through our Neo La Jolla laboratory that George mentioned. David Westenberg -- Guggenheim Securities -- Analyst. I would say that our -- the current trends, we've had a resurgence recently in COVID cases, but it doesn't seem to be affecting our clinical business. What we're seeing despite resurgence and unemployment continuing at levels that they are at is that our business is recovering. Modern oncology drug development continues to select for smaller groups of patients defined by unique molecular modifications and our pharma clients now ask for a much larger range of molecular targets. Yeah, hey, it's a little granular to think about it. The… And so, right now, we're initiating the validation studies for validating that FDA-approved panel and we think we have a clear pathway, we think it's perhaps one of family of FDA-approved tests that you will see NeoGenomics initiate over the next several years and we feel pretty good about it. Overall, we believe that the strategic pharma investments that we have made in recent years have been the right ones. And then, a lot of moving parts on liquid biopsy screening tests, I mean you had GRAIL getting acquired by Illumina, Exact this morning acquiring Thrive, you had CMS coming out with some screening benchmarks. Please go ahead. Got it. Clinical division revenues increased 17% year-over-year, boosted significantly by the contribution from COVID-19 PCR testing. Investor Relations Doug Brown Chief Strategy and Corporate Development Officer T: 239.768.0600 x2539 M: 704.236.2064 doug.brown@neogenomics.com, Charlie Eidson Manager of Investor Relations and Manager of Strategy and Corporate Development T: 239.768.0600 x2726 M: 952.221.8816 charlie.eidson@neogenomics.com, Transfer Agent Standard Registrar & Transfer Company 12528 South 1840 East Draper, UT 84020 T: (801) 571-8844, Contact Us | Careers | Licensing | Terms | Privacy, NeoLAB™ Liquid Biopsy for Hematologic Diseases, NeoGenomics To Virtually Participate In Fireside Chat At The Stephens Annual Investment Conference 2020, Stephens Annual Investment Conference 2020. In the Pharma Services segment, the rebound we experienced in quarter three was driven by a momentum shift and strengthening as clinical trial activity began to resume. Got it. This acquisition of talent is key for two reasons, one, the development of new sequencing test and platforms is attractive to pharma clients for both research and companion diagnostic development and two, the development of customized testing solutions purpose fit for unique clinical trials and patient populations. Tejas Savant -- Morgan Stanley -- Analyst. NeoGenomics, Inc. specializes in cancer genetic testing and information services. The positive momentum in next-generation sequencing testing has continued in October with daily test volumes approximately 30% higher than last year. While we anticipated that the acquisition would be a temporary drag on our gross margins in 2020, we remain very excited about our La Jolla business, which we've actually -- we're actually not calling Human Longevity anymore. In terms of plans for Inivata's RaDaR MRD assay and the timelines to bring it to market, would you sort of consider sort of working with them to accelerate that just in line of -- in light of some of the movement you've seen here in terms of the draft LCD in place from Palmetto, you have a couple of peers sort of who will be on the market I guess by the time you guys plan to bring RaDaR to the U.S. Next-generation sequencing revenue currently represents nearly 20% of our total clinical division revenue. Early commercial efforts continue to be encouraging and we are finding a growing number of real-world use cases for our data. This is Griffin Sori[Phonetic] on for Brian. The following slide deck was published by NeoGenomics, Inc. in conjunction with this event. Both our clinical oncology business and our Pharma segment continued to grow throughout the quarter and ended the quarter much stronger. Unemployment doesn't seem to be a factor in our clinical business or our pharma business either. The importance of our international strategic investments can't be understated and the strong new bookings numbers we have been able to post in recent quarters, despite the global pandemic, is strong evidence that our strategy is the right one. Good morning, everyone. We try to be transparent about what's happening in our business. Test volume growth also improved for this product line as the quarter progressed. With the increasing interest in broader panels and Tumor Mutational Burden, our whole exome sequencing offering and bioanalytic capabilities provide pharma sponsors with a stronger solution of what can be derived from smaller panels. So maybe just confirm that and then help me think about, I know as we look at other places outside of testing and outside of oncology, so as you're talking about utilization kind of in that 90%, 95% range in a lot of ways, but that last leg seems to be the hardest part that's not coming back. We think it's going to be a terrific product for patients and a terrific product for us and you can assume that we're working hard together to make it happen. NIO's Chinese name, which translates to “Blue Sky Coming” originated from our vision of a future filled with blue skies. Before turning the call back to Doug VanOort, I want to let everyone know that we'll 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. And then, maybe just one last one. Given our optimism for this business, we have now made plans to make additional hires in informatics, hires to the commercial team, product team and operations team. So we're looking forward to improved margins in those areas. We've got a very strong backlog there and the trends look pretty good in our Clinical business. Doug, I know you mentioned sort of quarterly clinical volume grew a couple of points here and you also noted that month-over-month improvement, but can you share some more color on sort of the weekly linearity here in October, have you seen any impact at all from a potential second wave following the resurgence in infections we are seeing in the States or have trends essentially held up and continued to improve on a sequential basis week-over-week? Manager of Investor Relations and Manager of Strategy and Corporate Development … So when we budgeted, when we gave guidance early in the year long-term, we would expect our clinical volume growth to be in the kind of a 12% to 15% range and we're not yet at that level, but we're moving in that direction. In our clinical oncology business, test volume improved throughout the quarter as average daily test volume increased nearly 10% from the month of July to September. Hi, thank you for taking the question. No question, quarter three was operationally challenging as a result of the pandemic that we are all dealing with but overall, we are pleased with the company's performance. Well, we lost the call, so we are rejoining, sorry. Nice quarter for Pharma Services, how much of that was driven by clinical trials and can you give us a sense of how the clinical trial recovery is going? Please go ahead. We are currently validating a new RNA-based fusion assay for solid tumors, employing state-of-the-art technology, which we believe will be superior to DNA-based assays. Yeah, we clearly had capacity. As of September 30th, our backlog of signed contracts stood at $185 million, representing a 57% year-over-year growth and a new high watermark. Our NGS-based FDA submission is going well and we will soon be initiating active validation studies. We are more confident everyday that we are on a steady path toward growth levels consistent with our historical long term guidance. This global expansion has proved critical for us to participate in certain RFPs for important global clinical trial work. Following Kathryn's review, George Cardoza will provide some in-depth commentary about our growth investments within Pharma Services, and Doug Brown will make some comments about our strategy and other investments. Fair enough. Like many other companies, the extensive workplace protections and work from home measures we put in place had an effect on productivity. I think what we're seeing now in the marketplace in addition to a resurgence in COVID is a greater penetration of rapid tests. Intra-quarter trends were also positive in the Pharma Services segment. We view investment in these initiatives as highly strategic and we plan on updating investors on their impact over the coming quarters. Great, that's very helpful. NeoGenomics, Inc. William Bonello Chief Strategy and Corporate Development Officer Director, Investor Relations (239)690-4238 (w) (239)284-4314 (m) bill.bonello@neogenomics.com. So I think the pharma definitely are realizing the benefits of working with us and the demand for these is extremely strong. We also believe that our pharma business is stronger than it has ever been and we are well positioned to capitalize on a robust environment for oncology therapy development. As many of you know, George has been a senior leader at NeoGenomics for about 11 years, having served as our Chief Financial Officer and for the last three years as President of our Pharma Services division. Sir, the floor is yours. NeoGenomics (NEO) Investor Presentation - Slideshow. What was the year-over-year metrics for the broader cancer market? If you could just help us think about when we look at the trajectory, how much of a headwind is the decoupling in kind of separating out the Pharma Services piece versus what's more operational in nature and how we should think about that going forward obviously understanding kind of the pricing headwinds and the mix components we've already talked about? So a number of cross currents there but I don't think that any -- there's anything -- no surprises that we would point to in 2021 for AUP. So first one on -- if I could ask on the AUP, just given the puts and takes here from NGS and liquid biopsy test being introduced into the therapy management, liquid biopsy test being introduced into that and other assays is being introduced. At this point, we would like to open up the call for questions. We probably will come back to you on a future quarter with more color and more specifics around those activities. Well, thank you, Charlie. Let's conquer your financial goals together...faster. Click to enlarge. And then one on the liquid biopsy pipeline here. Would you expect Neo to play a role in liquid biopsy cancer screening, early stage screening or is the company going to stick with later stage such as treatment selection and recurrence monitoring? Great, thanks for the color. George A. Cardoza-- President, Pharma Services. The decision last year to invest in a formal informatics strategy and our dedication to creating value from our existing oncology testing data is already paying off. We feel great about our minority investment and will continue to monitor progress on the uptake of the InVisionFirst-Lung test and the development progress of the company's promising minimal residual disease or MRD pan-cancer monitored assay as we consider exercising our option to purchase Inivata. So that's where we are at the present time. Sure. Mr. Cooper, if you could please resignal so I could put you back in the queue and you could finish your question. Can you just give us an update on the companion diagnostics efforts and maybe how many of these you're working on right now in Pharma Services? As we've discussed on prior earnings call in the back half of 2019, we determined that our Pharma Services business had reached sufficient scale along with our anticipated growth or the timing was appropriate to invest in a pharma-dedicated testing infrastructure. Track . So just any thoughts on what it takes or what that might look like as we continue through the fourth quarter and 2021 would be great. While the lab was attractive to us the opportunity to add a talented molecular team was also a major factor in our purchase. Charlie Eidson Manager of Investor Relations and Manager of Strategy and Corporate Development T: 239.768.0600 x2726 M: 952.221.8816 charlie.eidson@neogenomics.com The promising recovery in our core oncology business along with a significant contribution from COVID-19 PCR testing significantly improved profitability. Yeah, so I think that the margin that you've seen over the last couple quarters was pretty indicative of what you would expect going forward. 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