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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 Or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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20-0094687
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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Title of Each Class
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Name of Exchange on Which Registered
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Common Stock, $0.0001 par value per share
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The NASDAQ Stock Market LLC
(The NASDAQ Global Market)
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Large accelerated filer
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¨
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Accelerated filer
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ý
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Emerging growth company
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ý
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•
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our expectations regarding our future operating results and capital needs, including our expectations regarding instrument, consumable and total revenue, operating expenses, sufficiency of cash on hand and operating and net loss;
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the success, costs and timing of implementation of our business model, strategic plans for our business and future product development plans;
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the regulatory regime and our ability to secure regulatory clearance or approval or reimbursement for the clinical use of our products, domestically and internationally;
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our ability to successfully commercialize Prosigna, our first
in vitro
diagnostic product;
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our ability to realize the potential payments set forth in our collaboration agreements;
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our strategic relationships, including with patent holders of our technologies, manufacturers and distributors of our products, collaboration partners and third parties who conduct our clinical studies;
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our intellectual property position;
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our ability to attract and retain key scientific or management personnel;
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our expectations regarding the market size and growth potential for our business; and
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our ability to sustain and manage growth, including our ability to expand our customer base, develop new products, enter new markets and hire and retain key personnel.
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increase the number of molecular targets that can be analyzed simultaneously in order to understand the complete biological pathway involving multiple genes;
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improve the overall efficiency of their laboratories by simplifying workflow and accelerating the rate of successfully completing their research;
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provide more reliable, precise and reproducible data about targeted genes and biological pathways;
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maximize the amount of biologic information extracted from precious tissue samples;
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minimize the computational intensity of complex genomic and proteomic analysis;
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process difficult-to-work-with specimens, such as tumor biopsies stored in FFPE format; and
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create more systematic and reliable ways to help transition their research discoveries into future clinical products.
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•
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Convenience
. We believe that physicians would prefer that molecular diagnostic tests be performed at a local level and in the same laboratory that performs other tests that the physicians may order. Local molecular diagnostic testing could provide physicians the same rapid turnaround of test results that they have learned to expect for other types of tests.
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•
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Economic Advantages
. We believe that hospitals and medical centers desire to make their clinical laboratories profit centers by performing tests and billing third-party payors. As diagnostic technologies become less complicated to administer, hospitals and medical centers tend to favor in-sourcing tests.
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•
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International Availability
. There is a critical need to increase access to molecular diagnostic tests for patients that live outside the United States. Currently, patients living outside the United States may be challenged to gain access to tests that are provided only by specialized laboratories located within the United States. We believe advanced molecular diagnostic testing will become more available to patients throughout the world when it can be provided by their local clinical laboratories.
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•
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Optimized for Pathway-Based Biology
. The nCounter Analysis System can profile up to 800 molecules in a single test tube, which allows customers to analyze interactions among hundreds of genes or proteins that mediate biological pathways.
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Digital Precision
. Our molecular barcodes hybridize directly to the target molecules in a sample allowing them to be counted. This generates digital data (1 molecule = 1 count) of excellent quality over a wide dynamic range of measurements and provides excellent reproducibility.
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•
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Simple Workflow
. The nCounter Analysis System’s minimal sample preparation and automated workflow enable the simultaneous analysis of hundreds of genes and proteins in approximately 24 hours between the time a sample is loaded into the system and results are obtained. Our nCounter Analysis System generates data that customers can evaluate without the use of complex bioinformatics.
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•
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Flexible Sample Requirements
. The nCounter Analysis System is able to unlock biologic information from minute amounts of a variety of challenging tissue samples, including FFPE samples, cell lysates and single cells.
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Versatility
. The FLEX configuration of the nCounter Analysis System provides clinical laboratories a single platform with the flexibility to support both clinical testing, by running Prosigna or Laboratory Developed Tests using nCounter-based reagents, and research, by processing translational research experiments and multiplexed assays using our research reagents.
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•
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Gene Expression
. Researchers can use the nCounter Analysis System to measure the degree to which individual genes in pathways are turned “on” or “off” by simultaneously quantifying the amount of messenger RNA, or mRNA, associated with each of up to 800 genes.
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•
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Protein Expression
. Today, researchers can use the nCounter Analysis System to measure simultaneously up to 30 proteins. Ultimately, we intend to expand this capability to an increased number of protein targets, limited only by the 800 target capacity of an assay and the number of antibodies that can be sourced and combined without cross-reaction.
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•
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Gene Mutations
. In late 2016, we launched our first assay to detect a particular type of gene mutation, known as single nucleotide variations. Our initial panel, targeting solid tumors, gives researchers the power to measure 104 different gene mutations simultaneously, at the same time as measuring the expression of other genes and proteins.
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•
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miRNA Expression
. Researchers can use the nCounter Analysis System to measure the simultaneous expression levels of up to 800 different miRNAs. The nCounter Analysis System is capable of highly multiplexed, direct digital detection and counting of miRNAs in a single reaction without amplification, thereby delivering high levels of sensitivity, specificity, precision, and linearity.
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Copy Number Variation
. Researchers can use the nCounter Analysis System to probe for structural variations that result in cells having an abnormal number of copies of one or more sections of the DNA. Researchers are able to conduct large-scale, statistically-powered studies of these copy number variations, or CNVs, by leveraging the nCounter Analysis System’s multiplexing capacity to assay up to 800 DNA regions in a single tube, with as little as 300 ng of DNA.
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Gene Fusions
. Researchers can use the nCounter Analysis System to detect gene fusion events that occur when one gene fuses to another gene. A number of design options are available for developing assays for
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nCounter
SPRINT
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nCounter MAX
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nCounter FLEX
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Target customer
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Individual researchers
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Core research labs
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Clinical labs
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Throughput (samples per day)
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24
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48
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48
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Expandable with additional prep station
(1)
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No
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Yes
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Yes
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Diagnostic menu
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No
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No
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Yes
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U.S. list price
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$149,000
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$235,000
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$265,000
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•
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Pan Cancer Gene Expression Panels.
A portfolio of panels designed to comprehensively analyze genes driving the growth of cancer cells, the immune system’s response, and the progression of the cancer, including:
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◦
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Pathways.
A novel set of 770 essential genes representing the signaling pathways implicated in cancer, including key driver genes, selected using a data-driven approach to identifying the genes most relevant to cancer biology.
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◦
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Immune Profiling.
A novel set of 770 genes designed in collaboration with cancer immunologists around the globe, combining markers for 24 different immune cell types and populations, 30 common cancer antigens and genes that represent all known categories of immune response including key checkpoint blockade genes.
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◦
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Progression.
A novel set of 770 genes addressing the key questions of what happens when cancer metastasizes, including genes for the study of angiogenesis, epithelial mesenchymal transition, extracellular matrix formation, and metastasis.
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PanCancer RNA: Protein Immune Profiling Panels.
Two panels that combine gene expression analysis of the 770 genes contained in the PanCancer Immune Profiling Gene Expression Panel with the analysis of up to 30 proteins of interest in measuring the immune system’s response to cancer or intracellular signaling.
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360 Gene Expression Panels.
These panels include our IO 360 and Breast Cancer 360 and represent a series of next generation panels that combine clinically actionable content for evaluating the tumor microenvironment and immune response along with validated signatures such as the Company's Tumor Inflammation Signature (TIS) and PAM 50 (Breast cancer subtyping) along with up to 30 additional signatures encompassing all aspects of the cancer. These panels may be combined with our 360 Data Analysis Service to provide access to propriety signature algorithms.
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Neuropathology and Neuroinflammation Gene Expression Panels.
Two new panels built in collaboration with leading drug developers, have been designed to address the growing biomarker needs in the field of neuroscience. These panels, which analyze approximately 770 genes profile mechanisms for neurodegenerative diseases as well as neuropsychiatric disorders.
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Autoimmune Disease Gene Expression Panels.
Two new panels created to address the specific challenges of autoimmune disease research, and assist with the understanding of the underlying mechanisms of autoimmune disease and for identification of potential responders and non-responders to drug treatments.
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nCounter Vantage 3D Panels.
A portfolio of panels that enable simultaneous analysis of DNA, RNA, and protein, eliminating the need to divide small samples among different experiments, including:
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◦
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RNA:Protein Solid Tumor Assay
— Panels for lysates and FFPE that profile key cancer pathway targets at the RNA, total protein, and phospho-protein level, including targets associated with PI3K, MAPK, EGFR, and more.
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◦
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DNA SNV Solid Tumor Panel
— A panel targeting 104 single nucleotide variants in 25 genes that are relevant to a variety of solid tumor types, currently available for MAX and FLEX systems.
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RNA Panels
— A series of seven 192-gene expression panels each designed to interrogate a focused area of cancer biology: Adaptive Immunity, Cancer Metabolism, Intracellular Signaling, Cellular Profiling, Wnt Pathway, Innate Immunity, and DNA Damage & Repair.
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◦
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Lung Fusions
— A panel targeting gene fusions that involve the following genes which are important in lung cancer: ALK, ROS, RET, and NTRK1.
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◦
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Leukemia Fusions
— A panel targeting 27 gene fusions that are important in leukemia.
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Other Gene Expression Panels
. A series of panels that allow researchers to conduct a wide variety of gene expression analysis, including analysis of both human and mouse immunology-related genes and inflammation-related genes.
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miRNA Expression Panels
. A family of panels that provide a cost-effective profiling solution capable of highly multiplexed, direct digital detection and counting of up to 800 miRNAs in a single reaction without amplification. Separate panels are available for use with samples from humans, mice, rats, and fruit flies.
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•
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Cancer Copy Number Variation Panel
. Enables copy number quantification for 87 genes commonly amplified or deleted in cancer.
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our nCounter Analysis System biology, chemistry, methods and hardware;
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specific applications for our nCounter Analysis System technology;
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our gene expression markers, methods and gene signatures for recurrence and drug response in certain forms of cancer;
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biological and chemical compositions, methods and hardware for enzyme and amplification free sequencing; and
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biological and chemical compositions, methods and hardware for multiplexed detection and quantification of protein and/or nucleic acid expression in a defined region of a tissue or cell.
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greater name and brand recognition, financial and human resources;
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broader product lines;
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larger sales forces and more established distributor networks;
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substantial intellectual property portfolios;
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larger and more established customer bases and relationships; and
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better established, larger scale and lower cost manufacturing capabilities.
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strong clinical and analytical validation data;
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acceptance into major clinical guidelines, including the National Comprehensive Cancer Network, or NCCN, the American Society of Clinical Oncologists, or ASCO, and the St. Gallen Consensus guidelines;
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health economic studies that may indicate that the test improves quality-adjusted survival and leads to reduced costs; and
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decision impact studies that show the test leads to better treatment decisions.
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•
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the Federal Anti-kickback Law and state anti-kickback prohibitions;
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the Federal physician self-referral prohibition, commonly known as the Stark Law, and state equivalents;
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the Federal Health Insurance Portability and Accountability Act of 1996, as amended;
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the Medicare civil money penalty and exclusion requirements;
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the Federal False Claims Act civil and criminal penalties and state equivalents;
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the Foreign Corrupt Practices Act, which applies to our international activities;
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the Physician Payment Sunshine Act; and
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the European Union's General Data Privacy Regulations, or GDPR.
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•
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changes in government programs (such as the National Institutes of Health) that provide funding to research institutions and companies;
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macroeconomic conditions and the political climate;
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•
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changes in the regulatory environment;
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•
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differences in budgetary cycles;
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competitor product offerings or pricing;
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market-driven pressures to consolidate operations and reduce costs; and
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•
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market acceptance of relatively new technologies, such as ours.
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•
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expand the commercialization of our products;
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fund our operations; and
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further our research and development.
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market acceptance of our products;
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the cost and timing of establishing additional sales, marketing and distribution capabilities;
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revenue and cash flow derived from existing or future collaborations;
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the cost of our research and development activities;
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the cost and timing of regulatory clearances or approvals;
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•
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the effect of competing technological and market developments; and
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•
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the extent to which we acquire or invest in businesses, products and technologies, including new licensing arrangements for new products.
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•
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greater name and brand recognition, financial and human resources;
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•
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broader product lines;
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•
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larger sales forces and more established distributor networks;
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•
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substantial intellectual property portfolios;
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•
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larger and more established customer bases and relationships; and
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•
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better established, larger scale, and lower cost manufacturing capabilities.
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•
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cost of capital equipment;
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•
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cost of consumables and supplies;
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reputation among customers;
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innovation in product offerings;
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•
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flexibility and ease-of-use;
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•
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accuracy and reproducibility of results; and
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compatibility with existing laboratory processes, tools and methods.
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•
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availability of reimbursement for testing services;
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•
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breadth of clinical decisions that can be influenced by information generated by tests;
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volume, quality, and strength of clinical and analytical validation data;
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inclusion in treatment guidelines; and
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economic benefit accrued to customers based on testing services enabled by products.
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required compliance with existing and changing foreign regulatory requirements and laws;
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required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;
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export or import restrictions;
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various reimbursement and insurance regimes;
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laws and business practices favoring local companies;
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longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
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political and economic instability, such as the anticipated exit of Great Britain from the European Economic Community;
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potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;
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difficulties and costs of staffing and managing foreign operations; and
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difficulties protecting or procuring intellectual property rights.
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dispose of assets;
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complete mergers or acquisitions;
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incur indebtedness;
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encumber assets;
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pay dividends or make other distributions to holders of our capital stock;
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make specified investments;
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engage in any new line of business; and
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engage in certain transactions with our affiliates.
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•
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disruption in our relationships with customers, distributors or suppliers as a result of such a transaction;
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•
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unanticipated liabilities related to acquired companies;
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difficulties integrating acquired personnel, technologies and operations into our existing business;
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diversion of management time and focus from operating our business;
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•
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increases in our expenses and reductions in our cash available for operations and other uses; and
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•
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possible write-offs or impairment charges relating to acquired businesses.
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•
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the federal Anti-kickback Law and state anti-kickback prohibitions;
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•
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the federal physician self-referral prohibition, commonly known as the Stark Law, and the state equivalents;
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•
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the federal Health Insurance Portability and Accountability Act of 1996, as amended;
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•
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the Medicare civil money penalty and exclusion requirements;
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•
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the federal False Claims Act civil and criminal penalties and state equivalents;
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•
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state physician gift bans and state, federal and foreign marketing expenditure disclosure laws; and
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•
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the Foreign Corrupt Practices Act, which applies to our international activities;
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•
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the European Union's General Data Protection Regulation.
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•
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We might not have been the first to make the inventions covered by each of our pending patent applications.
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•
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We might not have been the first to file patent applications for these inventions.
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•
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Others may independently develop similar or alternative products and technologies or duplicate any of our products and technologies.
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•
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It is possible that our pending patent applications will not result in issued patents, and even if they issue as patents, they may not provide a basis for commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties.
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•
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We may not develop additional proprietary products and technologies that are patentable.
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The patents of others may have an adverse effect on our business.
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•
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We apply for patents covering our products and technologies and uses thereof, as we deem appropriate. However, we may fail to apply for patents on important products and technologies in a timely fashion or at all.
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actual or anticipated quarterly variation in our results of operations or the results of our competitors;
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announcements by us or our competitors of new products, significant contracts, commercial relationships or capital commitments;
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failure to obtain or delays in obtaining product approvals or clearances from the FDA or foreign regulators;
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adverse regulatory or reimbursement announcements;
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issuance of new or changed securities analysts’ reports or recommendations for our stock;
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developments or disputes concerning our intellectual property or other proprietary rights;
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commencement of, or our involvement in, litigation;
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market conditions in the research and diagnostics markets;
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manufacturing disruptions;
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any future sales of our common stock or other securities;
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any change to the composition of the board of directors or key personnel;
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
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general economic conditions and slow or negative growth of our markets; and
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the other factors described in this “Risk Factors” section.
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•
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permit the board of directors to issue up to 15,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate;
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provide that the authorized number of directors may be changed only by resolution of the board of directors;
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provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;
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divide the board of directors into three classes;
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provide that a director may only be removed from the board of directors by the stockholders for cause;
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require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and may not be taken by written consent;
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provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;
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•
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prevent cumulative voting rights (therefore allowing the holders of a plurality of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);
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provide that special meetings of our stockholders may be called only by the chairman of the board, our chief executive officer or by the board of directors; and
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provide that stockholders are permitted to amend the bylaws only upon receiving at least two-thirds of the total votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class.
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Year ended December 31, 2017
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High
|
|
Low
|
||||
First quarter
|
$
|
23.25
|
|
|
$
|
16.50
|
|
Second quarter
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$
|
20.70
|
|
|
$
|
14.72
|
|
Third quarter
|
$
|
16.78
|
|
|
$
|
13.17
|
|
Fourth quarter
|
$
|
16.60
|
|
|
$
|
7.03
|
|
Year ended December 31, 2016
|
|
|
|
||||
First quarter
|
$
|
17.66
|
|
|
$
|
11.30
|
|
Second quarter
|
$
|
16.50
|
|
|
$
|
11.89
|
|
Third quarter
|
$
|
20.28
|
|
|
$
|
12.50
|
|
Fourth quarter
|
$
|
23.45
|
|
|
$
|
18.19
|
|
Plan Category
|
(a) Number of Securities
to be Issued Upon
Exercise of
Outstanding
Options, Warrants
and Rights
|
|
(b) Weighted
Average Exercise
Price of
Outstanding
Options,
Warrants and
Rights
|
|
(c) Number of Securities
Remaining Available
for Future Issuance
Under Equity
Compensation Plans
(Excluding Securities
Reflected in Column (a))
(1)
|
||||
Equity compensation plans approved by security holders:
|
|
|
|
|
|
||||
2004 Stock Option Plan
|
932,175
|
|
|
$
|
3.34
|
|
|
—
|
|
2013 Equity Incentive Plan
|
4,925,785
|
|
|
13.42
|
|
|
180,497
|
|
|
2013 Employee Stock Purchase Plan
|
—
|
|
|
N.A.
|
|
|
269,811
|
|
|
Equity compensation plans not approved by security holders
(2)
:
|
—
|
|
|
N.A.
|
|
|
—
|
|
|
Total
|
5,857,960
|
|
|
N.A.
|
|
|
450,308
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(In thousands, except per share amounts)
|
||||||||||||||||||
Consolidated Statements of Operations:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
114,905
|
|
|
$
|
86,489
|
|
|
$
|
62,667
|
|
|
$
|
47,593
|
|
|
$
|
31,403
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product and service revenue
|
31,880
|
|
|
30,245
|
|
|
26,126
|
|
|
21,149
|
|
|
15,009
|
|
|||||
Research and development
|
46,888
|
|
|
34,720
|
|
|
24,597
|
|
|
21,404
|
|
|
14,979
|
|
|||||
Selling, general and administrative
|
74,334
|
|
|
62,700
|
|
|
53,186
|
|
|
51,063
|
|
|
29,912
|
|
|||||
Total costs and expenses
|
153,102
|
|
|
127,665
|
|
|
103,909
|
|
|
93,616
|
|
|
59,900
|
|
|||||
Loss from operations
|
(38,197
|
)
|
|
(41,176
|
)
|
|
(41,242
|
)
|
|
(46,023
|
)
|
|
(28,497
|
)
|
|||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest income
|
809
|
|
|
390
|
|
|
233
|
|
|
272
|
|
|
68
|
|
|||||
Interest expense
|
(6,153
|
)
|
|
(5,672
|
)
|
|
(4,017
|
)
|
|
(4,140
|
)
|
|
(1,942
|
)
|
|||||
Other income (expense)
|
183
|
|
|
(515
|
)
|
|
(389
|
)
|
|
(147
|
)
|
|
(66
|
)
|
|||||
Revaluation of preferred stock warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,156
|
|
|||||
Total other income (expense)
|
(5,161
|
)
|
|
(5,797
|
)
|
|
(4,173
|
)
|
|
(4,015
|
)
|
|
(784
|
)
|
|||||
Net loss before provision for income taxes
|
(43,358
|
)
|
|
(46,973
|
)
|
|
(45,415
|
)
|
|
(50,038
|
)
|
|
(29,281
|
)
|
|||||
Provision for income taxes
|
(204
|
)
|
|
(116
|
)
|
|
(166
|
)
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
$
|
(43,562
|
)
|
|
$
|
(47,089
|
)
|
|
$
|
(45,581
|
)
|
|
$
|
(50,038
|
)
|
|
$
|
(29,281
|
)
|
Accretion of mandatorily redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,653
|
)
|
|||||
Net loss attributable to common stockholders
|
$
|
(43,562
|
)
|
|
$
|
(47,089
|
)
|
|
$
|
(45,581
|
)
|
|
$
|
(50,038
|
)
|
|
$
|
(33,934
|
)
|
Net loss per share—basic and diluted
|
$
|
(1.84
|
)
|
|
$
|
(2.34
|
)
|
|
$
|
(2.40
|
)
|
|
$
|
(2.80
|
)
|
|
$
|
(4.44
|
)
|
Weighted-average shares used in computing basic and diluted net loss per share
|
23,731
|
|
|
20,116
|
|
|
19,027
|
|
|
17,839
|
|
|
7,643
|
|
|
As of December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and short-term investments
|
$
|
77,555
|
|
|
$
|
74,036
|
|
|
$
|
49,044
|
|
|
$
|
72,225
|
|
|
$
|
42,656
|
|
Working capital
|
86,002
|
|
|
77,402
|
|
|
61,882
|
|
|
76,411
|
|
|
42,106
(1)
|
|
|||||
Total assets
|
136,762
|
|
|
126,373
|
|
|
92,869
|
|
|
102,068
|
|
|
64,372
(1)
|
|
|||||
Total long-term debt and lease financing obligations, net of unamortized debt issue costs (includes current portion)
|
48,931
|
|
|
47,424
|
|
|
41,226
|
|
|
30,246
|
|
|
18,293
(1)
|
|
|||||
Total stockholders’ equity
|
$
|
40,109
|
|
|
$
|
12,305
|
|
|
$
|
20,215
|
|
|
$
|
44,813
|
|
|
$
|
31,469
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|||||||||||||||
|
(Dollars in thousands)
|
|||||||||||||||||||
Americas
|
$
|
86,099
|
|
|
75
|
%
|
|
$
|
60,330
|
|
|
70
|
%
|
|
$
|
41,265
|
|
|
66
|
%
|
Europe & Middle East
|
21,791
|
|
|
19
|
%
|
|
18,497
|
|
|
21
|
%
|
|
14,807
|
|
|
24
|
%
|
|||
Asia Pacific
|
7,015
|
|
|
6
|
%
|
|
7,662
|
|
|
9
|
%
|
|
6,595
|
|
|
10
|
%
|
|||
Total revenue
|
$
|
114,905
|
|
|
100
|
%
|
|
$
|
86,489
|
|
|
100
|
%
|
|
$
|
62,667
|
|
|
100
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands)
|
||||||||||
Platform technology
|
$
|
16,645
|
|
|
$
|
10,312
|
|
|
$
|
6,749
|
|
Manufacturing process development
|
3,025
|
|
|
2,582
|
|
|
1,802
|
|
|||
Life sciences research products and applications
|
7,933
|
|
|
6,298
|
|
|
4,982
|
|
|||
Diagnostic product development
|
7,161
|
|
|
6,648
|
|
|
3,727
|
|
|||
Clinical, regulatory and medical affairs
|
7,036
|
|
|
5,111
|
|
|
4,939
|
|
|||
Facility allocation
|
5,088
|
|
|
3,769
|
|
|
2,398
|
|
|||
Total research and development expense
|
$
|
46,888
|
|
|
$
|
34,720
|
|
|
$
|
24,597
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|||||||||||||||
|
(Dollars in thousands)
|
|||||||||||||||||||
Product revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Instruments
|
$
|
20,839
|
|
|
18
|
%
|
|
$
|
24,229
|
|
|
28
|
%
|
|
$
|
20,974
|
|
|
33
|
%
|
Consumables
|
38,311
|
|
|
33
|
%
|
|
37,545
|
|
|
43
|
%
|
|
30,597
|
|
|
49
|
%
|
|||
In vitro
diagnostic kits
|
6,745
|
|
|
6
|
%
|
|
4,168
|
|
|
5
|
%
|
|
2,457
|
|
|
4
|
%
|
|||
Total product revenue
|
65,895
|
|
|
57
|
%
|
|
65,942
|
|
|
76
|
%
|
|
54,028
|
|
|
86
|
%
|
|||
Service revenue
|
6,115
|
|
|
5
|
%
|
|
3,192
|
|
|
4
|
%
|
|
2,611
|
|
|
4
|
%
|
|||
Total product and service revenue
|
72,010
|
|
|
62
|
%
|
|
69,134
|
|
|
80
|
%
|
|
56,639
|
|
|
90
|
%
|
|||
Collaboration revenue
|
42,895
|
|
|
38
|
%
|
|
17,355
|
|
|
20
|
%
|
|
6,028
|
|
|
10
|
%
|
|||
Total revenue
|
$
|
114,905
|
|
|
100
|
%
|
|
$
|
86,489
|
|
|
100
|
%
|
|
$
|
62,667
|
|
|
100
|
%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2017
|
|
2016
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Product revenue:
|
|
|
|
|
|
|
|
||||||
Instruments
|
$
|
20,839
|
|
|
$
|
24,229
|
|
|
$
|
(3,390
|
)
|
|
(14)%
|
Consumables
|
38,311
|
|
|
37,545
|
|
|
766
|
|
|
2%
|
|||
In vitro
diagnostic kits
|
6,745
|
|
|
4,168
|
|
|
2,577
|
|
|
62%
|
|||
Total product revenue
|
65,895
|
|
|
65,942
|
|
|
(47
|
)
|
|
—%
|
|||
Service revenue
|
6,115
|
|
|
3,192
|
|
|
2,923
|
|
|
92%
|
|||
Total product and service revenue
|
72,010
|
|
|
69,134
|
|
|
2,876
|
|
|
4%
|
|||
Collaboration revenue
|
42,895
|
|
|
17,355
|
|
|
25,540
|
|
|
147%
|
|||
Total revenue
|
$
|
114,905
|
|
|
$
|
86,489
|
|
|
$
|
28,416
|
|
|
33%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2017
|
|
2016
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Cost of product and service revenue
|
$
|
31,880
|
|
|
$
|
30,245
|
|
|
$
|
1,635
|
|
|
5%
|
Product and service gross profit
|
$
|
40,130
|
|
|
$
|
38,889
|
|
|
$
|
1,241
|
|
|
3%
|
Product and service gross margin
|
56
|
%
|
|
56
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2017
|
|
2016
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Research and development expense
|
$
|
46,888
|
|
|
$
|
34,720
|
|
|
$
|
12,168
|
|
|
35%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2017
|
|
2016
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Selling, general and administrative expense
|
$
|
74,334
|
|
|
$
|
62,700
|
|
|
$
|
11,634
|
|
|
19%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2017
|
|
2016
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Interest income
|
$
|
809
|
|
|
$
|
390
|
|
|
$
|
419
|
|
|
107%
|
Interest expense
|
(6,153
|
)
|
|
(5,672
|
)
|
|
(481
|
)
|
|
8%
|
|||
Other income (expense), net
|
183
|
|
|
(515
|
)
|
|
698
|
|
|
(136)%
|
|||
Total other income (expense), net
|
$
|
(5,161
|
)
|
|
$
|
(5,797
|
)
|
|
$
|
636
|
|
|
(11)%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2016
|
|
2015
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Product revenue:
|
|
|
|
|
|
|
|
||||||
Instruments
|
$
|
24,229
|
|
|
$
|
20,974
|
|
|
$
|
3,255
|
|
|
16%
|
Consumables
|
37,545
|
|
|
30,597
|
|
|
6,948
|
|
|
23%
|
|||
In vitro
diagnostic kits
|
4,168
|
|
|
2,457
|
|
|
1,711
|
|
|
70%
|
|||
Total product revenue
|
65,942
|
|
|
54,028
|
|
|
11,914
|
|
|
22%
|
|||
Service revenue
|
3,192
|
|
|
2,611
|
|
|
581
|
|
|
22%
|
|||
Total product and service revenue
|
69,134
|
|
|
56,639
|
|
|
12,495
|
|
|
22%
|
|||
Collaboration revenue
|
17,355
|
|
|
6,028
|
|
|
11,327
|
|
|
188%
|
|||
Total revenue
|
$
|
86,489
|
|
|
$
|
62,667
|
|
|
$
|
23,822
|
|
|
38%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2016
|
|
2015
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Cost of product and service revenue
|
$
|
30,245
|
|
|
$
|
26,126
|
|
|
$
|
4,119
|
|
|
16%
|
Product and service gross profit
|
$
|
38,889
|
|
|
$
|
30,513
|
|
|
$
|
8,376
|
|
|
27%
|
Product and service gross margin
|
56
|
%
|
|
54
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2016
|
|
2015
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Research and development expense
|
$
|
34,720
|
|
|
$
|
24,597
|
|
|
$
|
10,123
|
|
|
41%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2016
|
|
2015
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Selling, general and administrative expense
|
$
|
62,700
|
|
|
$
|
53,186
|
|
|
$
|
9,514
|
|
|
18%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||
|
2016
|
|
2015
|
|
Dollars
|
|
Percentage
|
||||||
|
(Dollars in thousands)
|
||||||||||||
Interest income
|
$
|
390
|
|
|
$
|
233
|
|
|
$
|
157
|
|
|
67%
|
Interest expense
|
(5,672
|
)
|
|
(4,017
|
)
|
|
(1,655
|
)
|
|
41%
|
|||
Other income (expense), net
|
(515
|
)
|
|
(389
|
)
|
|
(126
|
)
|
|
32%
|
|||
Total other income (expense), net
|
$
|
(5,797
|
)
|
|
$
|
(4,173
|
)
|
|
$
|
(1,624
|
)
|
|
39%
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands)
|
||||||||||
Cash used in operating activities
|
$
|
(51,657
|
)
|
|
$
|
(6,079
|
)
|
|
$
|
(43,362
|
)
|
Cash provided by (used in) investing activities
|
(2,490
|
)
|
|
(30,261
|
)
|
|
23,769
|
|
|||
Cash provided by financing activities
|
59,668
|
|
|
35,093
|
|
|
24,268
|
|
|
Payments due by period
|
||||||||||||||||||
Contractual Obligations
(1)
|
Total
|
|
Less than 1
Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than 5
Years
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Lease obligations
(2)
|
$
|
46,627
|
|
|
$
|
5,316
|
|
|
$
|
10,725
|
|
|
$
|
11,259
|
|
|
$
|
19,327
|
|
Long-term debt obligations
(3)
|
49,315
|
|
|
—
|
|
|
—
|
|
|
36,987
|
|
|
12,328
|
|
|||||
Purchase obligations
(4)
|
4,407
|
|
|
4,407
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
100,349
|
|
|
$
|
9,723
|
|
|
$
|
10,725
|
|
|
$
|
48,246
|
|
|
$
|
31,655
|
|
•
|
revenue recognition;
|
•
|
stock-based compensation;
|
•
|
inventory valuation;
|
•
|
fair value measurements; and
|
•
|
income taxes.
|
|
Page(s)
|
Financial Statements:
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
|
(In thousands, except par value
amounts)
|
||||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
26,136
|
|
|
$
|
20,583
|
|
Short-term investments
|
51,419
|
|
|
53,453
|
|
||
Accounts receivable, net
|
19,564
|
|
|
22,193
|
|
||
Inventory, net
|
20,057
|
|
|
13,812
|
|
||
Prepaid expenses and other current assets
|
4,745
|
|
|
3,744
|
|
||
Total current assets
|
121,921
|
|
|
113,785
|
|
||
Restricted cash
|
143
|
|
|
143
|
|
||
Property and equipment, net
|
14,057
|
|
|
12,158
|
|
||
Other assets
|
641
|
|
|
287
|
|
||
Total assets
|
$
|
136,762
|
|
|
$
|
126,373
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
4,092
|
|
|
$
|
4,935
|
|
Accrued liabilities
|
4,507
|
|
|
3,494
|
|
||
Accrued compensation and other employee benefits
|
8,634
|
|
|
8,240
|
|
||
Customer deposits
|
8,945
|
|
|
610
|
|
||
Deferred revenue, current portion
|
9,229
|
|
|
19,033
|
|
||
Deferred rent, current portion
|
512
|
|
|
13
|
|
||
Lease financing obligations, current portion
|
—
|
|
|
58
|
|
||
Total current liabilities
|
35,919
|
|
|
36,383
|
|
||
Deferred revenue, net of current portion
|
3,304
|
|
|
22,664
|
|
||
Deferred rent and other liabilities, net of current portion
|
8,499
|
|
|
7,655
|
|
||
Long-term debt and lease financing obligations, net of current portion and debt issuance costs
|
48,931
|
|
|
47,366
|
|
||
Total liabilities
|
96,653
|
|
|
114,068
|
|
||
Commitments and contingencies (Note 13)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.0001 par value, 15,000 shares authorized; none issued
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value, 150,000 shares authorized; 25,421 and 21,528 shares issued and outstanding at December 31, 2017 and 2016, respectively
|
2
|
|
|
2
|
|
||
Additional paid-in-capital
|
353,308
|
|
|
281,900
|
|
||
Other comprehensive loss
|
(99
|
)
|
|
(57
|
)
|
||
Accumulated deficit
|
(313,102
|
)
|
|
(269,540
|
)
|
||
Total stockholders’ equity
|
40,109
|
|
|
12,305
|
|
||
Total liabilities and stockholders’ equity
|
$
|
136,762
|
|
|
$
|
126,373
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands, except per share amounts)
|
||||||||||
Revenue:
|
|
|
|
|
|
||||||
Product and service
|
$
|
72,010
|
|
|
$
|
69,134
|
|
|
$
|
56,639
|
|
Collaboration
|
42,895
|
|
|
17,355
|
|
|
6,028
|
|
|||
Total revenue
|
114,905
|
|
|
86,489
|
|
|
62,667
|
|
|||
Costs and expenses:
|
|
|
|
|
|
||||||
Cost of product and service revenue
|
31,880
|
|
|
30,245
|
|
|
26,126
|
|
|||
Research and development
|
46,888
|
|
|
34,720
|
|
|
24,597
|
|
|||
Selling, general and administrative
|
74,334
|
|
|
62,700
|
|
|
53,186
|
|
|||
Total costs and expenses
|
153,102
|
|
|
127,665
|
|
|
103,909
|
|
|||
Loss from operations
|
(38,197
|
)
|
|
(41,176
|
)
|
|
(41,242
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
809
|
|
|
390
|
|
|
233
|
|
|||
Interest expense
|
(6,153
|
)
|
|
(5,672
|
)
|
|
(4,017
|
)
|
|||
Other income (expense)
|
183
|
|
|
(515
|
)
|
|
(389
|
)
|
|||
Total other income (expense)
|
(5,161
|
)
|
|
(5,797
|
)
|
|
(4,173
|
)
|
|||
Net loss before provision for income taxes
|
(43,358
|
)
|
|
(46,973
|
)
|
|
(45,415
|
)
|
|||
Provision for income taxes
|
(204
|
)
|
|
(116
|
)
|
|
(166
|
)
|
|||
Net loss
|
$
|
(43,562
|
)
|
|
$
|
(47,089
|
)
|
|
$
|
(45,581
|
)
|
Net loss per share—basic and diluted
|
$
|
(1.84
|
)
|
|
$
|
(2.34
|
)
|
|
$
|
(2.40
|
)
|
Weighted average shares used in computing basic and diluted net loss per share
|
23,731
|
|
|
20,116
|
|
|
19,027
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands)
|
||||||||||
Net loss
|
$
|
(43,562
|
)
|
|
$
|
(47,089
|
)
|
|
$
|
(45,581
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Change in unrealized gain (loss) on short-term investments
|
(42
|
)
|
|
(28
|
)
|
|
14
|
|
|||
Comprehensive loss
|
$
|
(43,604
|
)
|
|
$
|
(47,117
|
)
|
|
$
|
(45,567
|
)
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
|
(In thousands)
|
|||||||||||||||||||||
Balances at January 1, 2015
|
18,272
|
|
|
$
|
2
|
|
|
$
|
221,724
|
|
|
$
|
(43
|
)
|
|
$
|
(176,870
|
)
|
|
$
|
44,813
|
|
Issuance of common stock net of issuance costs of $0.5 million
|
960
|
|
|
—
|
|
|
12,518
|
|
|
—
|
|
|
—
|
|
|
12,518
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
136
|
|
|
—
|
|
|
1,295
|
|
|
—
|
|
|
—
|
|
|
1,295
|
|
|||||
Exercise of stock options
|
202
|
|
|
—
|
|
|
876
|
|
|
—
|
|
|
—
|
|
|
876
|
|
|||||
Exercise of common stock warrants, net
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
6,278
|
|
|
—
|
|
|
—
|
|
|
6,278
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(45,581
|
)
|
|
(45,581
|
)
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
14
|
|
|
—
|
|
|
14
|
|
|||||
Balances at December 31, 2015
|
19,570
|
|
|
2
|
|
|
242,693
|
|
|
(29
|
)
|
|
(222,451
|
)
|
|
20,215
|
|
|||||
Issuance of common stock net of issuance costs of $1.0 million
|
1,333
|
|
|
—
|
|
|
26,073
|
|
|
—
|
|
|
—
|
|
|
26,073
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
139
|
|
|
—
|
|
|
1,489
|
|
|
—
|
|
|
—
|
|
|
1,489
|
|
|||||
Exercise of stock options
|
349
|
|
|
—
|
|
|
2,607
|
|
|
—
|
|
|
—
|
|
|
2,607
|
|
|||||
Exercise of common stock warrants, net
|
133
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Vesting of restricted stock units
|
5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
9,038
|
|
|
—
|
|
|
—
|
|
|
9,038
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(47,089
|
)
|
|
(47,089
|
)
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
(28
|
)
|
|
—
|
|
|
(28
|
)
|
|||||
Balances at December 31, 2016
|
21,529
|
|
|
2
|
|
|
281,900
|
|
|
(57
|
)
|
|
(269,540
|
)
|
|
12,305
|
|
|||||
Issuance of common stock net of issuance costs of $1.3 million
|
3,450
|
|
|
—
|
|
|
56,486
|
|
|
—
|
|
|
—
|
|
|
56,486
|
|
|||||
Issuance of common stock warrants
|
—
|
|
|
—
|
|
|
674
|
|
|
—
|
|
|
—
|
|
|
674
|
|
|||||
Issuance of common stock for employee stock purchase plan
|
139
|
|
|
—
|
|
|
1,793
|
|
|
—
|
|
|
—
|
|
|
1,793
|
|
|||||
Exercise of stock options
|
228
|
|
|
—
|
|
|
1,086
|
|
|
—
|
|
|
—
|
|
|
1,086
|
|
|||||
Exercise of common stock warrants, net
|
29
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Vesting of restricted stock units
|
46
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
11,369
|
|
|
—
|
|
|
—
|
|
|
11,369
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(43,562
|
)
|
|
(43,562
|
)
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
(42
|
)
|
|
—
|
|
|
(42
|
)
|
|||||
Balances at December 31, 2017
|
25,421
|
|
|
$
|
2
|
|
|
$
|
353,308
|
|
|
$
|
(99
|
)
|
|
$
|
(313,102
|
)
|
|
$
|
40,109
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands)
|
||||||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(43,562
|
)
|
|
$
|
(47,089
|
)
|
|
$
|
(45,581
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
||||||
Depreciation and amortization
|
3,354
|
|
|
2,977
|
|
|
2,377
|
|
|||
Stock-based compensation expense
|
11,369
|
|
|
9,038
|
|
|
6,278
|
|
|||
Amortization (accretion) of discount or premium on short-term investments
|
198
|
|
|
(20
|
)
|
|
270
|
|
|||
Interest accrued on long-term debt
|
171
|
|
|
158
|
|
|
18
|
|
|||
Conversion of accrued interest to long-term debt
|
1,472
|
|
|
1,357
|
|
|
1,067
|
|
|||
(Gain) loss on disposal of property and equipment
|
15
|
|
|
(2
|
)
|
|
3
|
|
|||
Provision for bad debt
|
361
|
|
|
—
|
|
|
34
|
|
|||
Provision for inventory obsolescence
|
866
|
|
|
822
|
|
|
248
|
|
|||
Changes in operating assets and liabilities
|
|
|
|
|
|
||||||
Accounts receivable
|
2,277
|
|
|
(2,476
|
)
|
|
(7,328
|
)
|
|||
Inventory
|
(8,742
|
)
|
|
(5,857
|
)
|
|
(5,602
|
)
|
|||
Prepaid expenses and other
|
(911
|
)
|
|
72
|
|
|
1,199
|
|
|||
Other assets
|
(367
|
)
|
|
37
|
|
|
(7
|
)
|
|||
Accounts payable
|
(110
|
)
|
|
869
|
|
|
(166
|
)
|
|||
Accrued liabilities
|
1,312
|
|
|
(40
|
)
|
|
(80
|
)
|
|||
Accrued compensation and other employee benefits
|
295
|
|
|
281
|
|
|
1,242
|
|
|||
Customer deposits
|
8,335
|
|
|
610
|
|
|
—
|
|
|||
Deferred revenue
|
(29,161
|
)
|
|
29,948
|
|
|
(127
|
)
|
|||
Deferred rent and other liabilities
|
1,171
|
|
|
3,236
|
|
|
2,793
|
|
|||
Net cash used in operating activities
|
(51,657
|
)
|
|
(6,079
|
)
|
|
(43,362
|
)
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(4,284
|
)
|
|
(3,991
|
)
|
|
(3,796
|
)
|
|||
Proceeds from sale of property and equipment
|
—
|
|
|
4
|
|
|
6
|
|
|||
Proceeds from sale of short-term investments
|
3,600
|
|
|
4,700
|
|
|
3,000
|
|
|||
Proceeds from maturity of short-term investments
|
79,599
|
|
|
34,800
|
|
|
57,309
|
|
|||
Purchases of short-term investments
|
(81,405
|
)
|
|
(65,774
|
)
|
|
(32,750
|
)
|
|||
Net cash (used in) provided by investing activities
|
(2,490
|
)
|
|
(30,261
|
)
|
|
23,769
|
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from long-term debt
|
—
|
|
|
5,000
|
|
|
10,000
|
|
|||
Repayment of long-term debt and lease financing obligations
|
(58
|
)
|
|
(226
|
)
|
|
(271
|
)
|
|||
Proceeds from sale of common stock, net
|
56,486
|
|
|
26,223
|
|
|
12,518
|
|
|||
Proceeds from issuance of common stock warrants
|
674
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from exercise of common stock warrants
|
—
|
|
|
—
|
|
|
2
|
|
|||
Proceeds from issuance of common stock for employee stock purchase plan
|
1,793
|
|
|
1,489
|
|
|
1,295
|
|
|||
Deferred offering costs
|
—
|
|
|
—
|
|
|
(152
|
)
|
|||
Tax withholdings related to net share settlements of restricted stock units
|
(313
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from exercise of stock options
|
1,086
|
|
|
2,607
|
|
|
876
|
|
|||
Net cash provided by financing activities
|
59,668
|
|
|
35,093
|
|
|
24,268
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
5,521
|
|
|
(1,247
|
)
|
|
4,675
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
32
|
|
|
(26
|
)
|
|
(42
|
)
|
|||
Cash and cash equivalents
|
|
|
|
|
|
||||||
Beginning of year
|
20,583
|
|
|
21,856
|
|
|
17,223
|
|
|||
End of year
|
$
|
26,136
|
|
|
$
|
20,583
|
|
|
$
|
21,856
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
|
(In thousands)
|
||||||||||
Supplemental disclosures
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
4,416
|
|
|
$
|
4,071
|
|
|
$
|
2,844
|
|
Cash paid for taxes
|
154
|
|
|
217
|
|
|
69
|
|
|||
Purchases of property and equipment, accrued but not paid
|
—
|
|
|
275
|
|
|
640
|
|
|||
Rental instruments reclassified from inventory
|
1,023
|
|
|
801
|
|
|
772
|
|
|||
Non-cash inventory exchange for services
|
—
|
|
|
28
|
|
|
112
|
|
|||
Non-cash capital lease
|
—
|
|
|
—
|
|
|
48
|
|
|||
Accrual of offering costs
|
—
|
|
|
—
|
|
|
29
|
|
Type of securities as of December 31, 2017
|
Amortized cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair value
|
||||||||
Corporate debt securities
|
$
|
35,567
|
|
|
$
|
—
|
|
|
$
|
(53
|
)
|
|
$
|
35,514
|
|
U.S. government-related debt securities
|
15,951
|
|
|
—
|
|
|
(46
|
)
|
|
15,905
|
|
||||
Total available-for-sale securities
|
$
|
51,518
|
|
|
$
|
—
|
|
|
$
|
(99
|
)
|
|
$
|
51,419
|
|
Type of securities as of December 31, 2016
|
Amortized cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair value
|
||||||||
Corporate debt securities
|
$
|
36,198
|
|
|
$
|
4
|
|
|
$
|
(42
|
)
|
|
$
|
36,160
|
|
U.S. government-related debt securities
|
17,312
|
|
|
1
|
|
|
(20
|
)
|
|
17,293
|
|
||||
Total available-for-sale securities
|
$
|
53,510
|
|
|
$
|
5
|
|
|
$
|
(62
|
)
|
|
$
|
53,453
|
|
|
2017
|
|
2016
|
||||
Maturing in one year or less
|
$
|
39,985
|
|
|
$
|
46,310
|
|
Maturing in one to three years
|
11,434
|
|
|
7,143
|
|
||
Total available-for-sale securities
|
$
|
51,419
|
|
|
$
|
53,453
|
|
|
Less Than 12 Months
|
|
12 Months or
Greater
|
|
Total
|
||||||||||||||||||
|
Fair
value
|
|
Gross
unrealized
losses
|
|
Fair
value
|
|
Gross
unrealized
losses
|
|
Fair
value
|
|
Gross
unrealized
losses
|
||||||||||||
Corporate debt securities
|
$
|
26,857
|
|
|
$
|
(53
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,857
|
|
|
$
|
(53
|
)
|
U.S. government-related debt securities
|
8,911
|
|
|
(40
|
)
|
|
3,994
|
|
|
(6
|
)
|
|
12,905
|
|
|
(46
|
)
|
||||||
Total
|
$
|
35,768
|
|
|
$
|
(93
|
)
|
|
$
|
3,994
|
|
|
$
|
(6
|
)
|
|
$
|
39,762
|
|
|
$
|
(99
|
)
|
•
|
Level 1 — Quoted prices in active markets for identical assets and liabilities.
|
•
|
Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets.
|
•
|
Level 3 — Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
|
Type of securities as of December 31, 2017
|
Fair value measurement using:
|
||||||||||||||
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
22,398
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
22,398
|
|
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
—
|
|
|
35,514
|
|
|
—
|
|
|
35,514
|
|
||||
U.S. government-related debt securities
|
—
|
|
|
15,905
|
|
|
—
|
|
|
15,905
|
|
||||
Total
|
$
|
22,398
|
|
|
$
|
51,419
|
|
|
$
|
—
|
|
|
$
|
73,817
|
|
Type of securities as of December 31, 2016
|
Fair value measurement using:
|
||||||||||||||
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|||||||||
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
16,715
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,715
|
|
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
—
|
|
|
36,160
|
|
|
—
|
|
|
36,160
|
|
||||
U.S. government-related debt securities
|
—
|
|
|
17,293
|
|
|
—
|
|
|
17,293
|
|
||||
Total
|
$
|
16,715
|
|
|
$
|
53,453
|
|
|
$
|
—
|
|
|
$
|
70,168
|
|
|
2017
|
|
2016
|
||||
Raw materials
|
$
|
5,743
|
|
|
$
|
4,277
|
|
Work in process
|
4,845
|
|
|
4,046
|
|
||
Finished goods
|
9,469
|
|
|
5,489
|
|
||
Total inventory
|
$
|
20,057
|
|
|
$
|
13,812
|
|
|
Useful Life
(Years)
|
|
2017
|
|
2016
|
||||
Manufacturing equipment
|
5
|
|
$
|
8,395
|
|
|
$
|
6,445
|
|
Lease and loaner instruments
|
1 - 5
|
|
4,106
|
|
|
3,581
|
|
||
Prototype instruments
|
2
|
|
2,938
|
|
|
2,975
|
|
||
Computer equipment
|
3
|
|
2,067
|
|
|
1,592
|
|
||
Furniture and fixtures
|
5
|
|
1,670
|
|
|
1,642
|
|
||
Leasehold improvements
|
Various
|
|
11,971
|
|
|
8,878
|
|
||
Construction in progress
|
|
|
158
|
|
|
1,861
|
|
||
Total property and equipment, gross
|
|
|
31,305
|
|
|
26,974
|
|
||
Less: Accumulated depreciation and amortization
|
|
|
(17,248
|
)
|
|
(14,816
|
)
|
||
Total property and equipment, net
|
|
|
$
|
14,057
|
|
|
$
|
12,158
|
|
|
2017
|
|
2016
|
||||
Term loans payable
|
$
|
49,315
|
|
|
$
|
47,844
|
|
Lease financing obligations
|
—
|
|
|
58
|
|
||
Total long-term debt and lease financing obligations
|
49,315
|
|
|
47,902
|
|
||
Unamortized debt issuance costs
|
(384
|
)
|
|
(478
|
)
|
||
Current portion of lease financing obligations
|
—
|
|
|
(58
|
)
|
||
Long-term debt and lease financing obligations, net of debt issuance costs and current portion
|
$
|
48,931
|
|
|
$
|
47,366
|
|
2018
|
$
|
—
|
|
2019
|
—
|
|
|
2020
|
—
|
|
|
2021
|
36,987
|
|
|
2022
|
12,328
|
|
|
|
$
|
49,315
|
|
|
Shares
|
|
Weighted-
average exercise
price per share
|
|
Weighted-
average remaining
contractual
term (in years)
|
|
Aggregate
intrinsic value
(in thousands)
|
|||||
Outstanding at January 1,2017
|
4,721,941
|
|
|
$
|
12.00
|
|
|
7.41
|
|
$
|
48,670
|
|
Granted
|
1,180,086
|
|
|
17.90
|
|
|
|
|
|
|||
Canceled and forfeited
|
(478,078
|
)
|
|
15.90
|
|
|
|
|
|
|||
Exercised
|
(227,696
|
)
|
|
4.78
|
|
|
|
|
|
|||
Outstanding at December 31, 2017
|
5,196,253
|
|
|
$
|
13.32
|
|
|
6.98
|
|
$
|
3,861
|
|
|
|
|
|
|
|
|
|
|||||
December 31, 2017:
|
|
|
|
|
|
|
|
|||||
Options vested and expected to vest
|
4,792,694
|
|
|
$
|
13.07
|
|
|
6.84
|
|
$
|
3,861
|
|
Options exercisable
|
3,437,421
|
|
|
$
|
11.90
|
|
|
6.19
|
|
$
|
3,861
|
|
|
Outstanding
|
|
Exercisable
|
||||||
Exercise Price
|
Number of
Shares
|
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
|
Number of
Shares
|
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
||
$1.92
|
431,345
|
|
|
4.21
|
|
431,345
|
|
|
4.21
|
$2.24 – $6.72
|
494,155
|
|
|
3.87
|
|
494,155
|
|
|
3.87
|
$7.47 – $12.56
|
480,694
|
|
|
6.76
|
|
384,717
|
|
|
6.28
|
$12.77
|
674,356
|
|
|
7.06
|
|
488,124
|
|
|
7.04
|
$12.94
|
577,212
|
|
|
8.05
|
|
276,718
|
|
|
7.99
|
$13.01 – $14.95
|
360,230
|
|
|
7.62
|
|
241,553
|
|
|
7.42
|
$14.99 – $17.50
|
531,282
|
|
|
8.27
|
|
218,634
|
|
|
7.36
|
$17.89 – $18.90
|
1,346,556
|
|
|
7.63
|
|
806,525
|
|
|
6.66
|
$19.09 – $22.71
|
300,423
|
|
|
8.22
|
|
95,650
|
|
|
7.33
|
|
5,196,253
|
|
|
|
|
3,437,421
|
|
|
|
Non-vested RSUs
|
|
Share Equivalent
|
|
Weighted-Average Grant Date Fair Value
|
|||
Non-vested at January 1, 2017
|
|
163,602
|
|
|
$
|
15.70
|
|
Changes during the year:
|
|
|
|
|
|||
Granted
|
|
603,493
|
|
|
10.73
|
|
|
Vested
|
|
(66,956
|
)
|
|
15.77
|
|
|
Forfeited
|
|
(38,432
|
)
|
|
17.20
|
|
|
Non-vested at December 31, 2017
|
|
661,707
|
|
|
$
|
11.07
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Cost of revenue
|
$
|
719
|
|
|
$
|
548
|
|
|
$
|
471
|
|
Research and development
|
2,853
|
|
|
2,046
|
|
|
1,453
|
|
|||
Selling, general and administrative
|
7,047
|
|
|
5,602
|
|
|
3,919
|
|
|||
Total stock-based compensation expense
|
$
|
10,619
|
|
|
$
|
8,196
|
|
|
$
|
5,843
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Domestic
|
$
|
(44,324
|
)
|
|
$
|
(47,562
|
)
|
|
$
|
(46,065
|
)
|
Foreign
|
966
|
|
|
589
|
|
|
650
|
|
|||
Loss before income taxes
|
$
|
(43,358
|
)
|
|
$
|
(46,973
|
)
|
|
$
|
(45,415
|
)
|
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
||||||
Domestic
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Foreign
|
204
|
|
|
116
|
|
|
166
|
|
|||
Total provision for income taxes
|
$
|
204
|
|
|
$
|
116
|
|
|
$
|
166
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Income tax provision at statutory rate
|
$
|
(15,076
|
)
|
|
$
|
(16,010
|
)
|
|
$
|
(15,662
|
)
|
Tax on repatriated foreign earnings and other nondeductible items
|
179
|
|
|
135
|
|
|
401
|
|
|||
Change in tax credits
|
(2,361
|
)
|
|
(1,449
|
)
|
|
(792
|
)
|
|||
Change in valuation allowance
|
(19,792
|
)
|
|
17,824
|
|
|
16,706
|
|
|||
Change in tax rate
|
37,690
|
|
|
—
|
|
|
—
|
|
|||
Foreign tax and other
|
(436
|
)
|
|
(384
|
)
|
|
(487
|
)
|
|||
Total provision for income taxes
|
$
|
204
|
|
|
$
|
116
|
|
|
$
|
166
|
|
|
2017
|
|
2016
|
||||
Net operating loss carryforwards
|
$
|
49,662
|
|
|
$
|
70,694
|
|
Research and development tax credit carryforwards
|
6,505
|
|
|
4,572
|
|
||
Foreign tax credit carryforwards
|
448
|
|
|
—
|
|
||
Stock-based compensation
|
5,664
|
|
|
5,360
|
|
||
Other
|
6,382
|
|
|
7,827
|
|
||
Total deferred tax assets
|
68,661
|
|
|
88,453
|
|
||
Less: Valuation allowance
|
(68,661
|
)
|
|
(88,453
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Balance at beginning of year
|
$
|
88,453
|
|
|
$
|
70,629
|
|
|
$
|
53,923
|
|
Charged to costs and expenses
|
17,898
|
|
|
17,824
|
|
|
16,706
|
|
|||
Impact of change in tax rate
|
(37,690
|
)
|
|
—
|
|
|
—
|
|
|||
Balance at end of year
|
$
|
68,661
|
|
|
$
|
88,453
|
|
|
$
|
70,629
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Unrecognized tax benefits at beginning of year
|
$
|
1,524
|
|
|
$
|
1,041
|
|
|
$
|
777
|
|
Additions based on current year tax positions
|
644
|
|
|
483
|
|
|
264
|
|
|||
Unrecognized tax benefits at end of year
|
$
|
2,168
|
|
|
$
|
1,524
|
|
|
$
|
1,041
|
|
2018
|
$
|
5,316
|
|
2019
|
5,307
|
|
|
2020
|
5,418
|
|
|
2021
|
5,551
|
|
|
2022
|
5,708
|
|
|
Thereafter
|
19,327
|
|
|
|
$
|
46,627
|
|
|
2017
|
|
2016
|
|
2015
|
|||
Options to purchase common stock
|
5,335
|
|
|
4,711
|
|
|
4,069
|
|
Restricted stock units
|
313
|
|
|
115
|
|
|
—
|
|
Common stock warrants
|
317
|
|
|
491
|
|
|
572
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Americas
|
$
|
86,099
|
|
|
$
|
60,330
|
|
|
$
|
41,265
|
|
Europe & Middle East
|
21,791
|
|
|
18,497
|
|
|
14,807
|
|
|||
Asia Pacific
|
7,015
|
|
|
7,662
|
|
|
6,595
|
|
|||
Total revenue
|
$
|
114,905
|
|
|
$
|
86,489
|
|
|
$
|
62,667
|
|
|
Three months ended
|
||||||||||||||
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
(in thousands, except per share data)
|
||||||||||||||
2017
|
|
|
|
|
|
|
|
||||||||
Total revenue
|
$
|
18,063
|
|
|
$
|
34,592
|
|
|
$
|
27,016
|
|
|
$
|
35,234
|
|
Net loss
|
$
|
(18,852
|
)
|
|
$
|
(4,555
|
)
|
|
$
|
(11,404
|
)
|
|
$
|
(8,751
|
)
|
Net loss per share – basic and diluted
|
$
|
(0.87
|
)
|
|
$
|
(0.20
|
)
|
|
$
|
(0.45
|
)
|
|
$
|
(0.34
|
)
|
2016
|
|
|
|
|
|
|
|
||||||||
Total revenue
|
$
|
14,697
|
|
|
$
|
22,627
|
|
|
$
|
23,933
|
|
|
$
|
25,232
|
|
Net loss
|
$
|
(14,603
|
)
|
|
$
|
(10,805
|
)
|
|
$
|
(10,088
|
)
|
|
$
|
(11,593
|
)
|
Net loss per share – basic and diluted
|
$
|
(0.74
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.55
|
)
|
(i)
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
(ii)
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
Exhibit
|
|
|
|
Incorporated by Reference
|
||||||
Number
|
|
Description
|
|
Form
|
|
Filing Date
|
|
Number
|
|
Filed Herewith
|
3.1
|
|
|
10-Q
|
|
August 8, 2013
|
|
3.1
|
|
|
|
3.2
|
|
|
10-Q
|
|
August 8, 2013
|
|
3.2
|
|
|
|
4.1
|
|
|
S-1/A
|
|
June 13, 2013
|
|
4.1
|
|
|
|
4.2
|
|
|
S-1
|
|
May 20, 2013
|
|
4.2
|
|
|
|
4.3
|
|
|
S-1
|
|
May 20, 2013
|
|
4.3
|
|
|
|
4.4
|
|
|
S-1
|
|
May 20, 2013
|
|
4.6
|
|
|
|
4.5
|
|
|
S-1
|
|
May 20, 2013
|
|
4.7
|
|
|
|
4.6
|
|
|
S-1
|
|
May 20, 2013
|
|
4.9
|
|
|
|
4.7
|
|
|
8-K
|
|
August 8, 2017
|
|
4.1
|
|
|
|
10.1
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.1
|
|
|
|
10.2
|
|
|
S-1
|
|
May 20, 2013
|
|
10.2
|
|
|
|
10.3
|
|
|
S-1
|
|
May 20, 2013
|
|
10.3
|
|
|
|
10.4
|
|
|
S-1
|
|
May 20, 2013
|
|
10.4
|
|
|
|
10.5
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.5
|
|
|
Exhibit
|
|
|
|
Incorporated by Reference
|
||||||
Number
|
|
Description
|
|
Form
|
|
Filing Date
|
|
Exhibit
|
|
Filed Herewith
|
10.6
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.6
|
|
|
|
10.7
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.7
|
|
|
|
10.8
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.8
|
|
|
|
10.9
|
|
|
S-1/A
|
|
June 13, 2013
|
|
10.9
|
|
|
|
10.10+
|
|
|
S-1
|
|
May 20, 2013
|
|
10.8
|
|
|
|
10.11+
|
|
|
10-Q
|
|
August 9, 2017
|
|
10.1
|
|
|
|
10.12+
|
|
|
S-1
|
|
January 13, 2014
|
|
10.11
|
|
|
|
10.13+
|
|
|
10-Q
|
|
August 9, 2017
|
|
10.2
|
|
|
|
10.14+
|
|
|
10-K
|
|
March 11, 2016
|
|
10.12
|
|
|
|
10.15+
|
|
|
10-Q
|
|
August 9, 2017
|
|
10.3
|
|
|
|
10.16+
|
|
|
S-1
|
|
January 13, 2014
|
|
10.12
|
|
|
|
10.17+
|
|
|
|
|
|
|
|
|
X
|
|
10.18+
|
|
|
|
|
|
|
|
|
X
|
|
10.19+
|
|
|
|
|
|
|
|
|
X
|
|
10.20+
|
|
|
|
|
|
|
|
|
X
|
|
10.21
|
|
|
10-K
|
|
March 13, 2015
|
|
10.14
|
|
|
|
10.22
|
|
|
10-K
|
|
March 11, 2016
|
|
10.13
|
|
|
|
10.23
|
|
|
10-K
|
|
March 13, 2015
|
|
10.15
|
|
|
|
10.24
|
|
|
10-Q
|
|
August 4, 2016
|
|
10.1
|
|
|
|
10.25
|
|
|
10-K
|
|
March 13, 2015
|
|
10.16
|
|
|
|
10.26
|
|
|
10-Q
|
|
May 6, 2016
|
|
10.1
|
|
|
Exhibit
|
|
|
|
Incorporated by Reference
|
||||||
Number
|
|
Description
|
|
Form
|
|
Filing Date
|
|
Exhibit
|
|
Filed Herewith
|
10.27
|
|
|
10-Q
|
|
August 8, 2014
|
|
10.1
|
|
|
|
10.28
|
|
|
10-Q
|
|
August 5, 2015
|
|
10.2
|
|
|
|
10.29
|
|
|
10-K
|
|
March 11, 2016
|
|
10.19
|
|
|
|
10.30
|
|
|
10-Q
|
|
May 5, 2017
|
|
10.1
|
|
|
|
10.31
|
|
|
|
|
|
|
|
|
X
|
|
10.32
|
|
|
10-Q
|
|
August 8, 2014
|
|
10.2
|
|
|
|
10.33†
|
|
|
S-1
|
|
May 20, 2013
|
|
10.19
|
|
|
|
10.34†
|
|
|
S-1
|
|
May 20, 2013
|
|
10.20
|
|
|
|
10.35
|
|
|
S-1
|
|
May 20, 2013
|
|
10.21
|
|
|
|
10.36†
|
|
|
S-1
|
|
May 20, 2013
|
|
10.22
|
|
|
|
10.37
|
|
|
10-Q
|
|
May 11, 2015
|
|
10.1
|
|
|
|
10.38
|
|
|
10-Q
|
|
August 4, 2016
|
|
10.2
|
|
|
|
10.39†
|
|
|
10-Q
|
|
November 8, 2017
|
|
10.1
|
|
|
Exhibit
|
|
|
|
Incorporated by Reference
|
||||||
Number
|
|
Description
|
|
Form
|
|
Filing Date
|
|
Exhibit
|
|
Filed Herewith
|
10.40
|
|
|
8-K
|
|
January 8, 2018
|
|
|
|
1.1
|
|
10.41
|
|
|
8-K
|
|
January 8, 2018
|
|
|
|
1.2
|
|
21.1*
|
|
|
|
|
|
|
|
|
X
|
|
23.1*
|
|
|
|
|
|
|
|
|
X
|
|
24.1*
|
|
|
|
|
|
|
|
|
X
|
|
31.1*
|
|
|
|
|
|
|
|
|
X
|
|
31.2*
|
|
|
|
|
|
|
|
|
X
|
|
32.1*
|
|
|
|
|
|
|
|
|
X
|
|
32.2*
|
|
|
|
|
|
|
|
|
X
|
|
101.INS*
|
|
XBRL Instance Document.
|
|
|
|
|
|
|
|
X
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
|
|
|
X
|
101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
|
|
|
X
|
101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
|
|
|
X
|
101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
|
|
|
X
|
101.PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
|
|
|
|
X
|
*
|
Filed herewith.
|
+
|
Indicates a management contract or compensatory plan.
|
†
|
Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
NANOSTRING TECHNOLOGIES, INC.
|
|
|
|
By:
|
/s/ R. Bradley Gray
|
|
R. Bradley Gray
|
|
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ R. Bradley Gray
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
March 7, 2018
|
R. Bradley Gray
|
|
|
|
|
|
|
|
||
/s/ K. Thomas Bailey
|
|
Chief Financial Officer (Principal Accounting and Financial Officer)
|
|
March 7, 2018
|
K. Thomas Bailey
|
|
|
|
|
|
|
|
|
|
/s/ William D. Young
|
|
Chairman of the Board of Directors
|
|
March 7, 2018
|
William D. Young
|
|
|
|
|
|
|
|
|
|
/s/ Elisha W. Finney
|
|
Director
|
|
March 7, 2018
|
Elisha W. Finney
|
|
|
|
|
|
|
|
||
/s/ Nicholas Galakatos
|
|
Director
|
|
March 7, 2018
|
Nicholas Galakatos
|
|
|
|
|
|
|
|
||
/s/ Robert M. Hershberg
|
|
Director
|
|
March 7, 2018
|
Robert M. Hershberg
|
|
|
|
|
|
|
|
|
|
/s/ Kirk D. Malloy
|
|
Director
|
|
March 7, 2018
|
Kirk D. Malloy
|
|
|
|
|
|
|
|
||
/s/ Gregory Norden
|
|
Director
|
|
March 7, 2018
|
Gregory Norden
|
|
|
|
|
|
|
|
||
/s/ Charles P. Waite
|
|
Director
|
|
March 7, 2018
|
Charles P. Waite
|
|
|
|
NANOSTRING TECHNOLOGIES, INC
|
|
Joseph Beechem
|
|
|
|
/s/ Wayne D. Burns
|
|
/s/ Joseph Beechem
|
By:
Sr. VP, Operations & Administration
|
|
SVP of Research & Development
|
Date:
December 26, 2012
|
|
Date
December 27, 2012
|
EXECUTIVE
|
|
NANOSTRING TECHNOLOGIES, INC
|
|
|
|
By:
/s/ Joseph Beechem
|
|
By:
/s/ R. Bradley Gray
|
Name:
Joseph Beechem
|
|
Name:
R. Bradley Gray
|
|
|
Title:
President & CEO
|
Date:
October 30, 2017
|
|
Date:
November 7, 2017
|
By:
/s/ R. Bradley Gray
|
|
Date:
October 23, 2017
|
Name:
R. Bradley Gray
|
|
|
Title:
President & Chief Executive Officer
|
|
|
/s/ K. Thomas Bailey
|
|
Date: October 17, 2017
|
By:
/s/ R. Bradley Gray
|
|
Date:
January 16, 2018
|
Name:
R. Bradley Gray
|
|
|
Title:
President & Chief Executive Officer
|
|
|
/s/ K. Thomas Bailey
|
|
Date:
January 16, 2018
|
SECTION 1
|
Definitions; Interpretation.
|
SECTION 3
|
Conditions of Effectiveness.
|
Name of Subsidiary
|
|
State or other Jurisdiction of Incorporation
|
NanoString Technologies Europe Limited
|
|
United Kingdom
|
NanoString Technologies SAS
|
|
France
|
NanoString Technologies International, Inc.
|
|
Delaware
|
NanoString Technologies Germany GmbH
|
|
Germany
|
NanoString Technologies Asia Pacific Limited
|
|
Hong Kong
|
NanoString Technologies Singapore Pte Limited
|
|
Singapore
|
NanoString Technologies (Bejing) Co. Ltd.
|
|
China
|
NanoString Technologies Spain, S.L.
|
|
Spain
|
1.
|
I have reviewed this
Annual
Report on
Form 10-K
of NanoString Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ R. Bradley Gray
|
|
R. Bradley Gray
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
1.
|
I have reviewed this
Annual
Report on
Form 10-K
of NanoString Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ K. Thomas Bailey
|
|
K. Thomas Bailey
|
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ R. Bradley Gray
|
|
R. Bradley Gray
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ K. Thomas Bailey
|
K. Thomas Bailey
|
Chief Financial Officer
|
(Principal Financial and Accounting Officer)
|