Doug VanOort
Analyst · Craig-Hallum
Thank you, Kathryn. Before addressing your questions, I'll share some thoughts about our business. As you can tell from our quarterly results, we continue to benefit from our position as the leading cancer testing provider in the United States, where we are experiencing very high growth in both divisions, and our outlook suggest that that growth is likely to continue for the foreseeable future. In the Clinical division, we've recently added some of the largest and most recognizable hospital systems and oncology practices in the country, with most of that business still in front of us. And in the Pharma Services business, our backlog of signed contracts is larger than ever and our pipeline remains robust. With that as background, I'd like to focus my comments on two key topics. First, actions that we're taking to focus and fortify our operations to accommodate high levels of growth, including the final phase of the Genoptix integration; and second, investments we are making to enable those high level of -- high levels of growth to continue well into the future. In terms of fortifying our operations, we've recently taken a number of actions to maintain a laser focus on execution and to ensure that we consistently deliver the exceptional service that is expected of us. First, we hired an onboarded almost 200 full-time employees during the quarter. The additional technical staff and pathologists has put us in a much better position to accommodate continued growth while maintaining exceptional service. Second, we added much needed facility capacity in Fort Myers and in Aliso Viejo. This is providing additional lab and office space to accommodate existing volume and allow us to have capacity until the new Fort Myers headquarters and lab facility is completed in 2021. Third, we significantly upgraded our next generation sequencing instrumentation and assays during the quarter. We moved our assays to the high throughput NovaSeq instruments, upgraded our chemistry and optimized our pipeline. We also incorporated MSI that's microsatellite instability, and TMB, tumor mutational burden into most of our NGS panels, updated our gene list and upgraded our physician reports. With NGS growth rates well over 50%, these upgrades are providing us with much needed capacity, higher quality and the ability to streamline and further automate the workflow and processes. Fourth, we delayed the planned migration of Genoptix customers to the NeoGenomics systems and processes by three months. This is providing our teams additional time to finalize plans and prepare more thoroughly for a seamless client migration process. We feel very good about the Genoptix integration. While we made a decision to delay, we are on track with all other integration activities and synergies are tracking as expected. Customer retention is our top priority during the integration period and so far so good. In fact we have already stemmed the volume decline occurring when we took the business over, and organic growth for the combined company has been better than we expected at the beginning of the year. We also passed on several smaller M&A opportunities which could have been a distraction to our teams. With these actions we feel that our lab operation is ready to seamlessly complete the Genoptix integration and we'll be in great shape to accept greater volume with higher levels of productivity and efficiency. Now, let's turn our attention to investments we are making to enable high levels of growth to continue well into the future. I'll highlight just a few of these investments this morning. First, we continue to invest in new test development, particularly in next generation sequencing. We are in various stages of development with several next generation sequencing panels, including a comprehensive genomic profile for hematologic cancer, a 500 plus gene solid tumor profile, a suite of liquid biopsy offerings and NGS based test for a minimal residual disease. We have a well-defined plan and a much broader and deeper organizational capability to execute it than ever before. Second, we continue to invest in companion diagnostics. We have a unique and powerful capability to help develop and validate companion diagnostic tests and to quickly respond to new drug approvals with the timely launch of companion diagnostic test. Among the most important of those capabilities is our wide scale and scope across Pharma and Clinical markets, a broad reach to oncologists and pathologists, and access to a massive quantity of oncology specific test result data. Few labs have our same ability to take an oncology companion diagnostic test across the continuum from development through clinical trials and into the market. This capability is clearly a synergy of operating both the Pharma Services and Clinical Services operation focused in oncology, and increasingly our services are of interest to both Pharma and Clinical clients. We are currently winning Pharma Services business, because of our companion diagnostic capabilities and boosting our Clinical Services market share by being first to market with companion diagnostic test. We have a track record of responding quickly to new drug approvals. I'll give you several recent examples. We already have several offerings for NTRK, including four TRK inhibitor therapies, including a small fusion panel incorporating NTRK1, NTRK2 and NTRK3, and immunohistochemistry pan-TRK screening panel, and a FISH NTRK1, NTRK2 and NTRK3 assay. We have also incorporated NTRK into our neo-type next generation sequencing panels. We have also been a leading provider, if not the world's leading provider of PD-L1 testing for lung cancer and other neoplasms, and we were quick to market with the SP142 assay for triple-negative breast cancer as well as assays for other new indications. We have talked at length about PIK3CA, which is the companion diagnostic for Novartis Piqray, and have seen uptake that is even better than we expected. We also were quick to market with the QIAGEN therascreen companion diagnostic PCR assay for FGFR in metastatic bladder carcinoma and we have already included RET into some of our small fusion panels and have incorporated RET testing into several of our neo type offerings. In addition, we have over two dozen companion diagnostic assays in our pipeline of signed projects for a variety of pharma and biotech companies, and are increasingly in discussions to add to the pipeline. Finally, we had begun to make initial investments in data and informatics. We are quite excited about the possibilities here. Over the past year, a number of leading payers, providers and pharma services companies have approached us to partner on data and informatics related initiatives. We have developed our strategy and plans, have begun to build our team, and are investing to develop our capabilities and initial products. Areas of particular interest for us based on market research include clinical decision support, real world analytics, clinical trials matching and several other exciting ideas. We anticipate that informatics and data will enhance our competitive position in both Clinical and Pharma Services, and eventually, be an incremental source of revenue for the company. The need for precision oncology diagnostics is growing and changing rapidly. We believe that investments in advanced technologies, companion diagnostics and informatics have the potential to create exciting opportunities for future growth and continued market leadership for our company. In summary, quarter three results were extremely strong, and we feel good about our momentum heading into the rest of the year. More importantly, our leading position in the market is proving to offer significant sustainable competitive advantages today and in the future and we remain committed to further strengthening that position over time. I'll now hand the call back over to Bill Bonello to lead us through a question and answer period.