Chuck Kummeth
Analyst · Leerink Partners. Please proceed with your question
Thanks, Dave, and good morning, everyone. Thank you for joining us for our third quarter conference call. This has been an extraordinary quarter. First, I want to thank all the employees, suppliers and partners of Bio-Techne for their exemplary service as we have worked through the COVID-19 pandemic. We are happy to report that we have no coronavirus cases in any of our global sites and implemented proactive safety measures very early in the crisis in February to protect our employees. Our balance sheet is sound with a very strong cash position and low leverage. We have not conducted any restructuring or furloughs to date, easing the minds of our employees and enabling them to focus on serving our life science research customers and clinical diagnostics partners. While COVID-19 negatively impacted our business this quarter, primarily due to the temporary shutdown of academic labs, we are playing a critical role in the global fight to develop tests and cures for the virus. Overall, we were having a very strong Q3 until the virus pandemic had a pronounced impact on our business in mid-March. But even so, we ended the quarter with 6% organic growth. Adjusting for the impact of coronavirus in the quarter, we estimate our organic growth would have been closer to 9%. Our team also delivered incredibly strong operational results in Q3, with adjusted operating margins expanding year-over-year by 130 basis points to 36.5%, ahead of schedule and with strong cash flow. Now I’ll get into some details of the quarter. Starting with our performance by geography, the North American market was very strong with low double-digit growth organically in the quarter. Biopharma growth in the region was over 20%, while academia increased mid-single digit. In general, both end markets were impacted by COVID-19-related shutdowns starting in mid-March, although our academic market experienced a disproportionate negative impact from the virus. The good news is that these are academic labs, not large industrial manufacturing lines. As researchers return to the lab and get back to work, we anticipate utilization of our consumables will snap back very quickly. Overall, biopharma research activity has been less impacted by the virus, with many labs continuing to operate at varying capacities. I don’t believe we are alone in our belief that once this pandemic is under control, life sciences research will likely increase significantly. It appears everyone in society from governments through the private sector now knows what an antibody is; this can only be good for our industry. With current stay-at-home policies, many of our customers are spending much more time – of their time online. Therefore, we continue to focus on our digital marketing efforts that have driven significant increases in website traffic across our brands over the past couple of years. Search engine optimization, continual refinement of our website and digital advertising will remain a growth lever for the company going forward and will be even more important as a differentiator in the current pandemic environment. We have never done more webinars and digital projects to reach out to our customers. For example, we recently held an Exosome Diagnostics webinar for urologists, many of whom are working from home now and had over 100 participants. Moving on to Europe, which was positioned for a sequential recovery until the virus hit, finished the quarter with revenue down from last year by 7%. Here, we had a very strong quarter in Biologics as well as with our Simple Plex platform, which is seeing strong growth in COVID-19-related patient care decisions by monitoring cytokine storm onset and progression. However, this strength was not enough to offset the March shutdowns in academia, which especially impacted our Simple Western, Genomics, assay and reagent businesses in the quarter. It is still uncertain when European labs will begin to open back up, but we’re expecting this to be country-by-country process. So far, in April, our German business is showing signs of an initial recovery, with Italy potentially not far behind. Our largest business is in the U.K., which is likely to be a month or so behind Germany in the recovery process. Finally, we had a surprisingly strong Q3 in Asia. Given the complete shutdown in China in late February, we were prepared for a quarter of negative organic growth in this country, but finished with positive organic growth in the mid-single digits. This fantastic finish reflects the outstanding work done there by the local team. Our employees in China are back to work serving – servicing a research market that has largely turned back on and expecting to revert to their long-term trend of double-digit growth in Q4. The rest of Asia also performed extraordinary well in Q3 with growth in the mid-teens. However, many of these countries, including Japan, Korea and India are currently in varying states of lockdown and expected to remain so for most of Q4. Accordingly, we are expecting double-digit negative growth outside of China in Q4. Before I turn the call over to Jim for the financial review, I would like to provide some more detail on the initiatives that our company is working on to help our customers develop tests and find remedies for COVID-19. I will also provide an update on some of the strategic growth initiatives that will have the largest impact to our company for years to come. Starting with our COVID-19 initiatives, we are experiencing significant demand in ramping production of our proteins and antibodies used in coronavirus research, including reagents that are components in serological assays. Also, we are working with several health care providers in perfecting antibody assays using the traditional ELISA platform that can detect an individual exposure profile to COVID-19, something that many health experts believe will require mass testing before world economies can resume any sort of pre-COVID-19 normalcy. Also, as I mentioned in my commentary regarding Europe, we’ve experienced significant global interest in demand to leverage Ella as an automation tool for the detection and monitoring of COVID-19 patients that are potentially experiencing cytokine release syndrome. This dangerous condition represents a critical and potentially fatal point in disease management. In our Genomics division, we are supplying COVID-19 RNAscope Pro for virus detection in tissue, allowing researchers to confirm the organs that are impacted by this virus. And in Exosome Diagnostics, we have validated and preparing to perform COVID-19 real-time qPCR testing at our labs in both Munich, Germany and Waltham, Massachusetts. Following the implementation of processes and instruments to automate the test, we’ll be capable of processing over 200 samples a day and we can ramp further after that. This lab-developed test will provide rapid and reliable detection of patients with active COVID-19 infections. These are just a few examples of how practically every division of our company has pivoted resources to find innovative solutions for COVID-19 and participate on a global level to help eradicate this horrible virus. We are uniquely positioned to provide reagents and assays for all aspects of COVID-19 research and diagnostics, and our mission thrives in helping solve these types of problems. Next, I will provide an update on two of our important strategic growth platforms, cell and gene therapy as well as Exosome Diagnostics. Starting with cell and gene therapy, we continue to make progress on the construction of our new dedicated GMP protein factory. Construction of the facility remains on track to provide GMP proteins in large-scale to our cell and gene therapy customers by the second half of fiscal 2021. We are very encouraged by initial interest in demand from biopharma customers as we actively market our coming GMP protein production capabilities and capacities. In fact, during the quarter, we executed our first large-scale GMP protein supply agreement. This customer is still making its way through the regulatory approval process for its therapy, making the GMP protein with a revenue likely in fiscal 2021. Many other customers have been engaging us with interest in long-term supply agreements to ensure continuity of supply for their present clinical studies and to meet their future commercial needs. In the meantime, our GMP portfolio has been growing at a rapid pace with a number of immune cytokines being used to grow cells in clinical trials. Also within our cell and gene therapy business, we have begun operationalizing the joint venture with Wilson Wolf and Fresenius Kabi that we announced last quarter. As a reminder, this commercial consortium offers a complete and simplified cell and gene therapy workflow solution using products from all three parties. During Q3, we focused on establishing a unified sales structure, a customer-facing website and point-of-sale and creating impactful marketing collateral, featuring all three parents’ offerings. In addition, the emerging interest in natural killer cell therapies for oncology has been demonstrating some great clinical potential. And the JV is well positioned for the renewed natural killer interest, leveraging our GMP proteins, cloud, media and PC buster platforms for cell genetic engineering of difficult to grow natural killer cells. Now an update on Exosome Diagnostics and the ExoDx prostate test. There were several positive developments in Q3, and there is still much to do to make sure this noninvasive prostate cancer test becomes available to all patients with heightened PSA levels who are contemplating a more expensive, more risky and painful tissue biopsy. Following the final local coverage decision, or LCD, from our Medicare Administrative Contractor or MAC, National Government Services, NGS, we have been billing Medicare for applicable patient tests and are receiving steady reimbursement for tests submitted to this important payer. Recall that our – we are currently preparing for the reconsideration process with our MAC, NGS to get the LCD more accurately mirroring the more inclusive NCCN Guidelines, which will expand the potential market size of the test. Based on our prior experience, we anticipate a public comment period to take place in the summer, followed by a final LCD in the fall. Continuing on the reimbursement front, we announced the receipt of an unlimited 10-year reimbursement contract with General Services Administration or GSA, making the ExoDx prostate test available to more than 140 government entities, including the Veterans Administration health care system. Our conversations with private payer community continue to progress, but many payers want to see a clinical utility study published prior to issuing favorable coverage decisions. We expect such publication in a leading peer-reviewed urology journal within the next couple of months. The clinical utility study shows improved patient compliance to either defer prostate biopsy or proceed with biopsy compared to the control arm when implementing the ExoDx prostate test in clinical practice. Due to this increased compliance to proceed with biopsy, physicians detected 30% more cases of clinically significant or high-grade prostate cancer compared to the standard of care control alarm. Implementing EPI not only saves the health care system money by avoiding unnecessary biopsies but also increases compliance among patients that need biopsies, leading to higher cancer detection rates. We anticipate the clinical utility and economic value shown in this study will resonate with the private payer community, increasing the frequency of our conversations and strengthening the argument for favorable coverage decisions. Currently, the coronavirus pandemic has had an impact on a number of individual-seeking wellness business which in turn has had an impact on the number of PSA tests and ultimately the number of ExoDx prostate tests conducted. We saw this play out during the month of March, and the decline in test has continued into April. We responded by recently launching an at home collection kit for our ExoDx prostate test, enabling men who are sheltering in place and thus unable to see a health care professional to know if a biopsy should be prioritized. The solution was launched with a patient-targeted marketing strategy, including Search Engine Optimization, a Facebook campaign and webinars to drive awareness that patients do not need to go into the urologist’s office to have access to this valuable test. We believe the flexibility of providing a urine sample at the convenience of the patient will be yet another key differentiator of the ExoDx prostate test from the competition. With a pipeline of additional tests, companion diagnostic applications and partnership opportunities, there are multiple avenues to create value with Exosome Diagnostics. We have a few partnerships in place and are in active discussions with several diagnostics and biopharmaceutical companies for potential applications of Exosome Diagnostics technology. In summary, I’m very proud of the way our team executed in our fiscal third quarter, especially considering the global challenges created by COVID-19. The pandemic creates some near-term challenges, but also some near-term opportunities as we deploy reagents to enable vaccine and therapeutic discoveries and diagnostic solutions. Stepping back from the current environment, our pillars for growth are fully in place. We remain in the very early innings of realizing a tremendous liquid biopsy and cell and gene therapy potential opportunities. And our proteomic and genomic and analytical tools remain extremely well positioned in very underpenetrated markets. I firmly believe that the environment for life science research and diagnostics will be even stronger as we emerge from this pandemic, and we have the financial strength and product portfolio to capitalize on these opportunities. With that, I’ll turn the call over to Jim.