Chris Linthwaite
Analyst · BTIG. Your line is open
Thank you, Agnes. Good afternoon. Thank you for joining our fourth quarter and full year 2019 earnings call. The discovery and deployment of new biomarkers for disease insight and treatment is becoming more and more important to our industry, particularly biomarkers related to the immune system. We think this will be one of the biggest trends in life science research in the coming decade. As new biomarkers are revealed, integrating them in the clinical study requires technologies that allow many simultaneous measurements. Fluidigm is unique in the life sciences tool space because we provide innovative tools powering biomarker discovery and deployment at single-cell resolution for DNA, RNA, and protein. Furthermore, our tools are transforming biological understanding through spatial interrogation of tissue, including elucidating the tumor microenvironment. We sell our instrument platforms and consumables to leading academic medical centers, research centers, contract research organizations, and industrial biopharma entities for this purpose. In addition, our tools are useful in adjacent industries, including ag-bio, a broad category of companies. We are continuing to develop and improve consumables software and services for our customers to provide more complete, integrated workflows with recurring revenue streams and enjoy strong intellectual property protection for our technologies. We harness the power of two technology platforms; mass cytometry and microfluidics in new and compelling formats, enabling large panels as well as the processing of a broad range of sample numbers. In other words, we believe our prospects are bright as the science moves forward into our areas of strength. As a result of these trends, in Q4, we exceeded our guidance, increasing revenue on a sequential basis by $6 million and delivering 4% growth net of FX effects. On a full year basis, in particular, I'm pleased with the progress we made in delivering broader adoption of mass cytometry across multiple customer segments. We had notable customer expansion of this technology in the quarter, including adoption by Covance, a leading global CRO; establishment of a new mass cytometry Center of Excellence at the Georgetown Lombardi Comprehensive Cancer Center, emphasizing development of new imaging panels for pancreatic cancer, lung cancer, and liver transplantation. Significant new system placements in translational research centers in Germany, Japan, and China, driven by their increased investment in biomarker research. Although the microfluidics' business performed below our expectations, we saw healthy adoption of our Geno instrument platform related to the RNA-Seq library prep kit we introduced late in Q3. We are targeting a $300 million market opportunity and deliver revenue growth in line with our Q4 guidance for that product. Over time, we believe this product will catalyze portfolio growth in other microfluidic categories with revenue acceleration in the latter half of 2020. We've made good progress on the sales and marketing investments we foreshadowed in our last earnings call. These commercial investments complement our product innovation pipeline and our overall optimism for the future. In brief, for the full year 2019, we drove mass cytometry utilization with full year 2019 revenue growth of 23%, punctuated by very strong sales of our imaging system configuration. We innovated across our portfolio, launching more than 10 new products for mass cytometry and microfluidics. We increased our active installed base of mass cytometry units to 292 with 85 enabled for imaging. We witnessed exceptional growth in scientific knowledge enabled in part by these platforms. Specifically, publications developed with mass cytometry technology now exceed 1,000 in number, representing 59% growth over the past year with exciting findings across immunology, immune function, immuno-oncology, infectious disease, to name a few. Our mass cytometry technology-powered 75 new clinical trials during Q4 2019, a 25% increase from Q3, and we believe we are just beginning this journey in terms of the annual number of translational studies we can penetrate. We signed numerous new partnerships and collaboration agreements to supplement our organic initiatives, including a significant DARPA-funded development program and a software collaboration with Indica Labs around their powerful HALO offering for imaging mass cytometry. We strengthened our balance sheet by eliminating $150 million of debt in Q1 2019 and refinancing the remainder of our 2014 convertible notes in Q4. In 2020, we intend to build upon these foundational accomplishments and take Fluidigm to new heights. Shifting from prior accomplishments to perspectives on the market. I want to start with some comments on mass cytometry. Across all regions, our underlying markets remain healthy. From what we can determine, we did not experience any unusual budget flushes in Q4 compared to Q4 2018. We see strong market demand for analysis solutions and high parameter protein across tissue and cells, and we are seeing demand for new instruments as organizations build capabilities. We believe usage of established systems remain strong, while sales of new systems has grown and our base of recurring revenue streams from consumables and services is becoming a meaningful part of our revenue profile. In the U.S. market, we believe our prospects are good, with continued NIH funding growth and biopharma industrial investment. There is a steady increase in new clinical studies and trials, especially in the areas where we focus, namely immune response measurement. And for 2020, we don't anticipate fundamental changes in the funding landscape or competitive dynamics compared to 2019. With this market context, our underperformance in the Americas during the second half of the year is disappointing. Starting late in Q3, we conducted a review of our market assumptions, competitive positioning, and commercial effectiveness. And ask the question, how can we establish more consistent growth in the Americas, both from mass cytometry and microfluidics. We concluded that end market health and competitive dynamics were not the prime drivers of our underperformance. However, we did gain an important new insight. Despite our large opportunity funnel, our coverage model had not scaled with the accelerating growth of our mass cytometry installed base from the last two years. Furthermore, we had poor coverage of high value microfluidics accounts and prospects. Simply put, we were spread too thin on both business lines with a single-selling team. As a result, we began a series of commercial investments starting in Q4 and continuing into Q1 aimed at addressing this situation. We anticipate reaching our target commercial footprint in Q2 and we are on track with our hiring plans. We believe the incremental selling capacity in the Americas will accelerate our revenue growth as we enter the latter part of the year. We have deployed other levers to mitigate the potential adverse impact on our cash burn. In EMEA, we see relatively strong demand for our products despite the backdrop of slow GDP growth and Brexit dynamics. Overall, basic research funding is tight, but we see a shift in funding to areas where we are well-positioned. We are part of numerous consortium of researchers and industrial partners on disease research and biomarker development, especially immune-mediated diseases. We continue to focus on market development activities on these organizations, best positioned to benefit from the shifting research landscape. The landmark nature paper, we highlighted in January, is an amazing example of how we have partnered with a leading academic center in Zurich, who in turn, recruited a consortium with pathologists and hospitals to investigate novel biomarkers and cell populations important to breast cancer patient stratification and treatment. Their study suggests that high-parameter protein image analysis of tumors could be a game-changer. On the heels of these scientific breakthroughs, we believe further sales channel investment is required to build on our product momentum. Investments in sales heads for the German-speaking countries have delivered new growth in 2019, and we believe this trend will continue in 2020. In fact, we are investing in incremental selling resources for the entire EMEA region, primarily microfluidics, which will allow our existing mass cytometry team, which previously carried microfluidics in their bag to sharpen their focus. We think it will be a win-win for both franchises as we deploy a specialist sales model while increasing our direct-selling presence in key countries. In addition, conversion in some territories from distributors to direct sales makes more and more financial sense as we gain scale in those locations. Similar to the Americas and EMEA, the APAC region is shifting funding to immuno-oncology and immune system-related tools and related programs. In absolute terms, China and Japan are the fastest-growing markets, followed by Korea, Singapore, and Australia. Highlighting this market trend, the Japanese government has funded a five-year national immuno-oncology program. In Q4, we sold Imaging Mass Cytometry systems to key research centers that were awarded projects. We believe these placements will drive recurring revenue streams in the coming years and we hope these projects result in new biomarker panels, important to prevention, early detection, and therapy. China has shifted national funding to large precision medicine in immuno-oncology programs as well as build out -- as well as the build-out of institutional infrastructure, top medical research centers. We have not modeled any adverse long-term impacts from the recent coronavirus outbreak. And similar to other research tools providers, we believe our tools will be critical to researching, preventing and addressing future infectious diseases. To capitalize on these growing markets, we are building out specialist teams to scale with the market demand in China. From a segment perspective, demand in large academic medical centers remain strong. We have penetrated more than half of the targeted U.S. and EMEA accounts in this segment. And in many situations, we have sold multiple systems. With the largest accounts approaching 10 or more installed units on the mass cytometry side of our business. Consumables are trending in line with our expectations, and we materially increased our clinical trial participation in 2019. We see incremental placement opportunities and new demand emerging from these institutions as well as emerging interest from mid-tier institutions. Our microfluidics' sales team focuses on these same segments, although the decision-makers and users differ in most institutions. The CRO and CRL segment is another strategically important segment, although not currently our largest end market in terms of annual revenue. We see this market segment increasing in importance for us over the course of the coming years as early stage clinical studies, scale, and larger biomarker panels become more common. With the addition of Covance this quarter, we are laying the foundation for future growth. We have a good group of smaller specialty CROs servicing demand of biopharma customers. We've just scratched the surface of the market potential. Similar to our model with other partners, starting with our Maxpar Direct Immune Profiling panel, Covance will market specialty services to pharma biotech customers. What makes Covance special is their ability to provide global scale and support for the larger programs we think will emerge. Over time, we can feed them new panels from our partnerships with academic centers to extend their service venue. We know that most biopharma customers need flexibility and pre-configured solutions and value speed to market. So, turnkey CRO partnerships will play an important role in our long-term success as we increased exposure to global drug development pipelines. Turning now to microfluidics, our microfluidics business is a platform technology, serving the broad genomics, for example, sequencing, real-time PCR and sample prep markets as well as the biomarker discovery portion of the proteomics market. These markets are very large with entrenched market participants. So, we need to be targeted in our approach. Our strategy is simple. For genomics applications, we've focused on high-value customers who appreciate our cost efficiency and automation. We use our innovation resources to target the biggest pain points for this type of research, such as library prep for RNA-Seq, a fragmented market with no integrated automated workflow. We achieved our guidance range for this product in Q4, and we anticipate steady growth in 2020, including geno instrument placements with a focus on larger genomics cores and service providers. Recently, we announced a key placement at MOgene, a St. Louis-based genomic service provider who has adopted Juno and our Advanta products, including the RNA-Seq NGS library prep product. We've been building a good pipeline for RNA-Seq and expect this to ramp as instruments are installed and validated with more revenue in the second half of 2020. The second arm of our strategy is collaborations and partnerships oriented on key applications in end markets, where the partner has existing channel or insight. We have an excellent collaboration with the proteomic services provider that is ripe for further enhancement and a robust business development funnel. Our technology is incredibly powerful, but we need channel support and content plays to capitalize on this potential. We intend to avoid commodity applications and stay focused. Our microfluidics business performance in 2019 was disappointing, largely because of weak demand from concentrated legacy customers. However, we have made steady investments in new applications, partnerships, and channel expansion that should generate attractive returns in due time. I'll now turn the call over to Vikram, our CFO for a complete review of our financial results.