Chris Linthwaite
Analyst · UBS. Your line is open
Thank you, Agnes. Good afternoon. The ongoing global pandemic has impacted every facet of our business and has driven a need for speed as well as crisp execution. Our disciplined operations, our relentless focus on employees' safety, addressing urgent COVID market needs through innovation, and a focused capital deployment plan has delivered results. I am proud of the entire Fluidigm team for rising to the occasion in a manner reflective of our shared values, including a commitment and a passion to serve the community in this crisis. We are humbled to be playing a role in both virus detection and decoding the complex immune system response to the pathogen, which will be critical to the next phase of pandemic response. The unfortunate events of 2020 have further validated our strategic vision, and suggest we can play an increasingly meaningful role in healthcare in the years ahead across many fronts. In 90 days, in a historically challenging operating environment, we accomplished goals normally tackled over a span of a year or more. We received the first FDA emergency use authorization for a kitted extraction-free saliva-based PCR test for detecting SARS-CoV-2 combining best-in-class throughput with minimal sample input. We powered groundbreaking multi-site and large single-site clinical trials and studies bringing the number of new trials year-to-date to 25, including three on our imaging platform for a total of 113 trials ongoing or complete. We secured a $34 million contract in the first class of the NIH RADx awardee group earmarked for COVID-19 test manufacturing scale-up and new product development. We delivered almost 800,000 tests in the quarter with the majority of the tests linked to the authorized kit released in late August. We placed 31 Biomarks in the quarter, with a total of 43 Biomark systems enabled for diagnostics year-to-date. These new accounts or customers are broadening our installed base into clinical labs poised to ramp production in coming quarters. We established partnerships with multiple CROs as well as a leading health IT provider, Healthvana, a mobile platform for integrating data from labs and delivering results to patients to better serve COVID testing market segment needs. Healthvana has helped more than three million patients receive test results since April. We announced an innovative Campus Safeguard Program, showcasing our opportunity to play a major role in helping to keep students and staff safe in higher education, navigating the global health crisis. We believe this program is increasing brand awareness of the Fluidigm solution to multiple stakeholders. Vikram will address key financial details and break down the quarter in a few minutes, but I'd like to add a few more -- a little bit more color on these accomplishments and their implications for the future. Since I became CEO four years ago, my mandate has been to shift from being a general-purpose research tools product push company towards a more end customer market-oriented solutions provider. We have great technology, a resilient, nimble and determined culture. And steadily, over the last few years, we have been shifting from quarterly instrument placements in academia towards recurring revenue streams in translational and clinical research settings as well as commercial molecular testing labs. We are entering larger markets and adding new high-value customers, who conduct cutting-edge research, with an intent to move these insights into broad deployment. New partnerships are also critical to our success and they are reflected in our announcements over the last 12 months. We expect to provide more of these kinds of announcements in the future as we execute on this strategy. In the last two years, we aligned around an investment thesis that understanding the immunome, a scientific area with huge impact on health care that requires insights into single-cells, bulk-cells and tissue was the future. We built robust solutions that hold the promise to create new standards for health care management across many diseases. With this pandemic, we are seeing those solutions actively being used to drive a deeper understanding of COVID-19 patient immune profiling. The SARS-CoV-2 pathogen and accompanying health care crisis illustrates the importance and the value of the strategic pivot. Early and accurate detection of the virus is critical to containment and the efficient deployment of health care assets such as hospital beds, clinics and personnel. Our Biomark solution combines the flexibility to detect the virus, add new data points or pathogen strains to our platform and upscale or downscale throughput based on the operational environmental needs. This flexibility provides critical decision-making information that covers multiple market segments including markets beyond diagnostics. Our innovation work is not done and we have an exciting array of new products in development including bar-coded assays that increase testing throughput, new chips to improve workflows and expanded test menu, as well as a next-generation Biomark system earmarked for release around midyear 2021. These products will extend our technology leadership and research in regulated markets while providing a platform for additional partnerships as we expand our diagnostics market presence in the future. I will share more details in the months ahead as well as commentary on how we envision the current COVID testing market might evolve in the coming years. From our perspective, COVID testing demand will be robust in 2021, the competitive landscape will be dynamic and the nimble and focused and execution-oriented companies will flourish. On the COVID research front, our mass cytometry suspension and imaging platforms have had a significant impact. Our Maxpar Direct Immune Profiling Assay released last year a 37-marker panel with a customized analytical package for measuring immune response has provided a standard method for assessing immune system response in infected populations. The suspension platform could be impactful for second stage vaccine development programs and novel therapeutic intervention studies. Our imaging platform is providing insights on immune response and tissue damage triggered by COVID infection. And our Therapeutic Insights Service has executed 20 studies including several oriented on COVID-related research. We have more innovation in our mass cytometry business on the horizon. In areas beyond COVID-19, our previously announced large OEM collaboration continues to progress well and we anticipate a product launch next year. We added an additional undisclosed partnership in Q3 and we have more discussions underway with prospects. Compared to Q2, we saw improvements in our core business, with notable upticks in service calls system installations and general consumables orders although most labs are not operating at historical levels. We also saw great results from our shift to digital marketing channels, including an extremely successful 9th Annual Mass Cytometry Summit with 700 live participants including 50% of the registrants who are new contacts. The Mass Cytometry Summit has become a showcase Fluidigm asset that our competitors are trying to emulate. In Q3 alone our digital events attracted 1800 self-identified prospects for the sales organization to nurture. These numbers reflect a return to historic trend lines as we shift from in-person events to digital events. Clearly we are optimistic about our future. However in the near term with the emergence of significant new outbreaks and associated regional lockdowns it is hard to predict performance in Q3 or Q4 let alone 2021. Our shift in diagnostics is new and we are starting from a modest footprint with a number of our customers not yet in full production mode. So we are cautious about predicting the ramp-up in testing volume. However, we remain very confident in our long-term prospects with the shape of our growth depending on a mix of factors including future research spending and an expansion of our diagnostic space. Turning to a discussion of longer-term strategy. In the background while we are executing on the COVID testing opportunity, we have been updating our long-term planning to incorporate the opportunities that have surfaced with this pandemic and the new assets we have built, including new customer relationships, new tools and a significant expansion of manufacturing capacity. We believe that we have access to a durable diagnostics business powered by microfluidics. In addition, we're well positioned in our suspension and imaging mass cytometry franchises for double-digit growth in translational clinical research and pathology markets. Across the company, we are executing on a pipeline of innovative new products including content, workflows and instruments strengthened by partnerships. I feel the company is on stronger footing to drive sustained future growth. Now I'd like to transition to Vikram for a detailed discussion of our operating results.