UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
☐
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2019
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM TO
Commission File Number 001-38943
Personalis, Inc.
(Exact name of Registrant as specified in its Charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
1330 O’Brien Drive
Menlo Park California
(Address of principal executive offices)
27-5411038
(I.R.S. Employer
Identification No.)
94025
(Zip Code)
Registrant’s telephone number, including area code: (650) 752-1300
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.0001
Securities registered pursuant to Section 12(g) of the Act: None
Trading
Symbol(s)
PSNL
Name of each exchange on which registered
The Nasdaq Global Market
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes ☒ No ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange
Act.
Large accelerated filer
Non-accelerated filer
Emerging growth company
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☒
☒
Accelerated filer
Smaller reporting company
☐
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, as of June 28, 2019, the last business day of the
Registrant’s most recently completed second fiscal quarter, was approximately $513,174,177 based on the closing price of the shares of common stock on the Nasdaq Global
Market. Excludes an aggregate of 12,220,162 shares of the registrant’s common stock held as of such date by officers, directors and stockholders that the registrant has
concluded are or were affiliates of the registrant. Exclusion of such shares should not be construed to indicate that the holder of any such shares possesses the power, direct
or indirect, to direct or cause the direction of the management or policies of the registrant or that such person is controlled by or under common control with the registrant.
The number of shares of Registrant’s Common Stock outstanding as of March 20, 2020 was 31,474,193.
Part III incorporates information by reference from the Registrant’s definitive proxy statement to be filed with the U.S. Securities and Exchange Commission pursuant to
Regulation 14A, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, in connection with the Registrant’s 2020 annual
meeting of stockholders (the “2020 Proxy Statement”).
DOCUMENTS INCORPORATED BY REFERENCE
Personalis, Inc.
Form 10-K
For the Year Ended December 31, 2019
Table of Contents
Special Note Regarding Forward-Looking Statements
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Exhibits, Financial Statement Schedules
Form 10-K Summary
Signatures
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PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
Page
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future
results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking
statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not
limited to, statements concerning the following:
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the evolution of cancer therapies and market adoption of our services;
estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing;
the impact of the COVID-19 pandemic on our business, our customers’ and suppliers’ businesses and the general economy;
our ability to compete effectively with existing competitors and new market entrants;
our ability to scale our infrastructure;
our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers;
expectations regarding our relationship with the U.S. Department of Veterans Affairs’ Million Veteran Program;
our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement;
potential effects of extensive government regulation;
our ability to hire and retain key personnel;
our ability to obtain financing in future offerings;
the volatility of the trading price of our common stock;
our belief that approval of personalized cancer therapies by the Food and Drug Administration may drive benefits to our business; and
our expectation regarding the time during which we will be an emerging growth company under the JOBS Act.
Actual events or results may differ from those expressed in forward-looking statements. As such, you should not rely on forward-looking
statements as predictions of future events. We have based the forward-looking statements contained in this Annual Report on Form 10-K primarily on our
current expectations and projections about future events and trends that we believe may affect our business, financial condition, operating results,
prospects, strategy, and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties,
assumptions, and other factors described in the section titled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a
highly competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks
and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report on Form 10-K. The results, events and
circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially
from those described in the forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are
based on information available to us as of the date of this Annual Report on Form 10-K. While we believe that such information provides a reasonable
basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an
exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on
these statements.
The forward-looking statements made in this Annual Report on Form 10-K relate only to events as of the date on which the statements are made.
We undertake no obligation to update any forward-looking statements made in this Annual Report on Form 10-K to reflect events or circumstances after
the date of this Annual Report on Form 10-K or to reflect new information, actual results, revised expectations, or the occurrence of unanticipated events,
except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should
not place undue reliance on our forward-looking statements.
Unless the context otherwise requires, references in this Annual Report on Form 10-K to the “company,” “Personalis,” “we,” “us” and “our”
refer to Personalis, Inc.
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Item 1. Business.
Overview
PART I
We are a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive
molecular data about each patient’s cancer and immune response. We designed our NeXT Platform to adapt to the complex and evolving understanding of
cancer, providing our biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, in
contrast to many cancer panels that cover roughly 50 to 500 genes. In parallel with the development of our platform technology, we have also provided
population sequencing services under contract with the U.S. Department of Veterans Affairs (the “VA”) Million Veteran Program (the “VA MVP”), which
has enabled us to innovate, scale our operational infrastructure, and achieve greater efficiencies in our lab.
We are also developing a complementary liquid biopsy assay that analyzes all of the approximately 20,000 human genes versus the more
narrowly focused liquid biopsy assays that are currently available. By combining technological innovation, operational scale, and regulatory differentiation,
our NeXT Platform is designed to help our customers obtain new insights into the mechanisms of response and resistance to therapy as well as new
potential therapeutic targets. Our platform enhances the ability of biopharmaceutical companies to unlock the potential of conducting translational research
in the clinic rather than with pre-clinical animal models or cancer cell lines. We also announced in January 2020 a diagnostic based on our NeXT Platform
that we envision being used initially by both leading clinical cancer centers as well as biopharmaceutical companies.
Our headquarters – housing our CLIA-certified, CAP-accredited laboratory – is located in Menlo Park, CA. We were incorporated under the laws
of the state of Delaware in February 2011 under the name Personalis, Inc. Our customers include biopharmaceutical companies (including large
pharmaceutical companies), universities, non-profits, and government entities.
Personalis: The Genomics Engine for Next-Generation Cancer Therapies
Biopharmaceutical customers use our comprehensive platform across a diverse set of therapeutic approaches to cancer. We generate and analyze
data from patients who participated in clinical trials, which we believe will enable these customers to develop more effective therapies. These opportunities
represent a significant end market that is much larger than our initial clinical-trial focused market.
The information we generate is important to our customers developing three major classes of next-generation therapeutics: immunotherapies,
targeted therapies, and personalized cancer therapies.
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Immunotherapies: Over the past decade, a number of drugs have emerged based on the discovery that the immune system plays a key role
in addressing cancer. Checkpoint inhibitors, a specific type of immunotherapy, has generated substantial increases in worldwide sales over
the past decade. The commercial success of these drugs has shown the potential of immunotherapy; however, the development of new
therapies in this category has been challenged by difficulties understanding the precise interaction between cancer and the immune system.
Since our platform provides comprehensive insights on tumor and immune biology, we believe it will enable biopharmaceutical companies
to better understand how therapeutics are working in patients.
Targeted Therapies: A growing category of successful cancer treatments consists of therapies that target specific genes or molecular
mechanisms of cancer. These drugs are not designed to influence the immune system directly but the success of immunotherapies has
brought acknowledgment that the immune system has a significant effect on their efficacy. Many of these targeted therapies are proposed to
be tested in combination with immunotherapies. These therapies have grown to represent a considerable share of the overall oncology
therapeutics market today. Comprehensively understanding each patient’s genomic and immune profile is critical to understanding which of
these therapies a patient may respond to. We believe that more comprehensive coverage of all of the approximately 20,000 genes positions
us competitively against existing cancer panels that cover roughly 50 to 500 genes. We are positioning our company to be a leading provider
of the complex information that we believe will continue to inform the development of targeted cancer therapies.
Personalized Cancer Therapies: Many biopharmaceutical companies are pursuing personalized cancer therapies, which are designed and
manufactured, individually, for each patient based on genomic alterations in a given patient’s tumor. While there are many potential
approaches to developing these therapies, including neoantigen-based vaccines and T-cell therapies, all of them can potentially benefit from
the data and analytics that our platform can generate about a patient’s tumor. Many of our customers have leveraged our U.S. Food and
Drug Administration (the “FDA”) Device Master File as a component of their investigational new drug (“IND”) filings with the FDA. We
anticipate that if drugs are approved
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that used our platform in the clinical trials forming the basis for approval, we may be able to derive revenue in connection with the sale of
these drugs. We believe we are working with the majority of companies developing neoantigen-targeted personalized cancer therapies.
We anticipate that as the clinical utility of our platform is validated, we will have opportunities in connection with diagnostics and the
commercialization of cancer therapeutics, which are significantly larger than our initial clinical-trial focused markets. Over time, we expect our
biopharmaceutical customers and research collaborators to build evidence of clinical utility for our platform as a diagnostic for advanced cancer therapies.
Separately, we are also acquiring samples and are building a database which will hold value for our biopharmaceutical customers and may ultimately allow
us to discover new mechanisms of cancer treatment.
Financial Highlights
Our revenues have grown rapidly as our penetration of clinical trials in advanced oncology therapeutics and our relationship with the VA MVP
has expanded, consistent with our reputation as a leader in the field. We generated revenues of $9.4 million, $37.8 million, and $65.2 million for the years
ended December 31, 2017, 2018, and 2019, respectively. We also incurred net losses of $23.6 million, $19.9 million, and $25.1 million for the years ended
December 31, 2017, 2018, and 2019, respectively.
As of December 31, 2019, we had $128.3 million of cash and cash equivalents and short-term investments, an increase of $108.5 million from
December 31, 2018. Our revenues are primarily generated through sales of our services to the VA MVP and biopharmaceutical companies. Unlike
diagnostic or therapeutic companies, we have not sought reimbursement through traditional healthcare payors. We raised $144.0 million in our June 2019
initial public offering, net of underwriter commissions, and prior to that had raised $89.6 million in preferred stock equity financing to date.
Our Products and Services
Our genomic sequencing and analytics solutions are focused on the following customer applications: Oncology research and immuno-oncology,
oncology diagnostics, and whole genome sequencing. We have one reportable segment from the sale of sequencing and data analysis services and
substantially all of our revenues to date have been derived from sales in the United States.
Oncology Research and Immuno-oncology
We work closely with biopharmaceutical companies who are advancing new therapies in three major areas: immunotherapies, targeted therapies,
and personalized cancer therapies. We have a critical role in generating new data and biological insight from patients in those clinical trials.
NeXT Platform
Our NeXT Platform is a high-accuracy, clinical-grade, next-generation sequencing and analysis platform that enables two services for our
customers: ImmunoID NeXT Tumor Biopsy and NeXT Liquid Biopsy (in development).
Our NeXT Platform is designed to provide comprehensive analysis of both a tumor and its immune microenvironment, from a single limited
tissue sample. Our platform covers the deoxyribonucleic acid (“DNA”) sequence of all of the approximately 20,000 human genes. We also report on the
entire transcriptome of a tumor, which encompasses ribonucleic acid (“RNA”) expression across the approximately 20,000 human genes, allowing us to
more accurately determine which of the many genomic mutations might actually be driving tumor progression. Furthermore, our platform analyzes
elements of the immune cells that have infiltrated a tumor both from the adaptive immune system and the innate immune system.
Given the practical challenges in obtaining high-quality tumor samples via biopsy, we have developed our platform to work with a limited tumor
tissue sample. Biopharmaceutical companies face significant challenges in attempting to divide samples to ship to multiple service providers to perform
different tests. If a biopharmaceutical company is successful in acquiring results from multiple service providers, it is challenging to compare the results
across multiple data platforms from multiple service providers. Our sequencing approach, validated with orthogonal technologies, allows us to run multiple
analyses on a single sample. Our platform is composed of multiple proprietary technologies, many of which we have developed from the ground up. The
breadth of the assays that we have integrated into our platform, our proprietary sample preparation process, and the comprehensiveness of our platform
allow us to maximize the utility of often limited tumor tissue samples that our customers have from their clinical trials. Revenues from early customer
pilots of NeXT Tumor Biopsy were recognized in Q4 2019.
An overview of key features and differentiators of our NeXT Platform follows.
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Comprehensive tumor and immune genomics from a single limited sample:
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Sequencing and analyzing all of the approximately 20,000 human genes generates more comprehensive molecular information than current
tumor tissue and liquid biopsy panels focused on roughly 50 to 500 genes
Covers a much broader set of biomarkers for new immunotherapies and traditional targeted therapies
Analysis of both tumor DNA and RNA expression
Analysis of both tumor and normal tissue
Analysis of non-human species such as oncoviruses
NeXT liquid biopsy, which we plan to launch in 2020, will target approximately 20,000 genes, enabling testing at multiple time points
Proprietary technology enables superior sequencing quality and advanced analytics
Makes single, comprehensive tumor molecular profiling practical for cancer patients:
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Tumor and immune molecular profiling from one limited tumor sample
Engineered to be cost-effective and scalable, with rapid turnaround times, making it suitable for large-scale profiling of cancer patients
Overcomes the need for fragmented tumor testing
One platform for both research and clinical use
Platform anticipates future cancer biomarkers that will come with evolving science:
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NeXT overcomes the limitations of small panels that become out of date when new genetic biomarkers or therapeutic targets are identified
Comprehensive coverage of all genes, DNA and RNA, tumor and normal tissue, and immune biology enables our platform to accommodate
new genetic biomarkers and signatures as they are published
Generates comprehensive, harmonized data across patients to enable large-scale database creation and insight:
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Comprehensive profiling for large cohorts of patients leads to more useful databases for biopharmaceutical customers using our platform
and our internal database
Opportunity for integration with other sources of real-world data (“RWD”) such as electronic health records to generate real-world evidence
(“RWE”) that may be used by biopharmaceutical customers to inform and accelerate therapeutic development
Data harmonization, analytics, and machine learning maximize therapeutic insight
Comprehensive nature of the platform provides long-lasting data relevance, yielding new insights over time as new biomarkers are
identified
We have also shown that our NeXT Platform technology can analyze cell-free DNA (“cfDNA”) obtained from blood plasma, also known as a
liquid biopsy. As with a tissue biopsy, we plan to analyze all of the approximately 20,000 human genes in each plasma sample, in contrast to currently
marketed liquid biopsy panels. We expect this cfDNA to be obtained by a blood draw concurrently with a tissue sample. Together, the two samples can be
used to provide a more comprehensive initial characterization of the tumor. Additionally, we expect to monitor changes in tumor genetics that arise in
response to therapy through serial measurements using cfDNA samples collected across multiple time points. In 2020, we plan to launch our first liquid
biopsy assay designed to analyze all human genes so as to detect potential neoantigens and tumor escape mechanisms that arise under therapeutic pressure.
Although we believe our cfDNA test will offer new insights, we believe it will be most useful for our biopharmaceutical customers alongside our primary
tumor biopsy product, given that a tumor biopsy is required to analyze gene expression and elucidate tumor-infiltrating lymphocytes which are critical to
understanding cancer’s interaction with the immune system.
An overview of key liquid biopsy capabilities follows.
Liquid biopsy approaches look at cfDNA in plasma samples derived from the blood. cfDNA is DNA that is released into circulation by cells,
including tumor cells, as a result of cell death. This cfDNA can be obtained by a blood draw and can be used to monitor changes in tumor genetics.
We believe tumor biopsy and liquid biopsy approaches to tumor molecular profiling can provide complementary information for each patient.
Tumor biopsies provide tumor immune microenvironment and tumor gene expression information that current liquid biopsy panels do not provide. Liquid
biopsies can be useful for providing additional DNA mutation information, especially for monitoring therapy response across different time points when
tumor biopsies are not feasible. Unlike typical liquid biopsy panel approaches focused on roughly 50 to 500 driver genes, we are designing our cfDNA
approach, NeXT Liquid Biopsy, which is currently in development, to sequence all of the approximately 20,000 genes in the human genome. Our broader
liquid biopsy approach will help biopharmaceutical customers identify biological changes across multiple time points for each patient in their trials that
they would otherwise miss with the current, narrowly focused liquid biopsy panels. We also believe broader coverage will enable better neoantigen
prediction, broader biomarker coverage, and higher potential to identify new drug targets.
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Figure 2: ImmunoID NeXT tumor biopsy and NeXT liquid biopsy (in development) yields complementary data.
We believe that combining tumor biopsies with cfDNA can provide a more complete picture of the spectrum of mutations found in a cancer
patient. As an example of this, we compared the mutations found in eight late-stage colorectal tumor biopsy samples with those found in the plasma taken
at the same time. We found a range of overlap between tumor biopsy-identified sequence variations and the sequences generated using cfDNA. These
observations show that, while there was significant overlap between the tumor and liquid biopsy results, there were also mutations unique to tumor biopsy
and vice versa (see examples of this in Figure 3). This observation underscores the concept that tissue and liquid biopsies may be complementary, and when
combined, may provide a more complete picture of the patient’s disease.
Figure 3. Overlap of sequence variations detected in matched tumor and blood plasma.
Numbers indicate variants detected in the tumor only, plasma only, or in both.
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We anticipate that our liquid biopsy approach will have many applications, including monitoring of tumor response to therapy over many time
points, detecting new genetic variants from evolution of the tumor under therapeutic pressure, detecting acquired mechanisms of resistance, and identifying
neoantigens.
NeXT makes comprehensive tumor molecular profiling practical for cancer patients at scale
To deliver a comprehensive immune-genomic assessment of a tumor, we invested substantial resources to engineer NeXT to provide data and
analysis that would otherwise be unavailable or require many individual technologies, which collectively present significant costs and logistical
impracticalities. With NeXT, we built a proprietary platform that is comprehensive, cost-effective, and scalable and enables a short turnaround time,
making it practical to profile cancer patients at scale. This has required innovation on a number of fronts.
ACE Platform
To address the limitations of typical NGS-based assay, we developed our patented Accuracy and Content Enhanced (“ACE”) technology for
next-generation sequencing. ACE improves nucleic acid preparation processes and combines it with patented assay and sequencing methods to achieve
superior, high-fidelity, clinical-grade sequencing quality that ensures high sensitivity for mutations that can inform clinical and therapeutic applications
such as neoantigen prediction, biomarker identification, and novel drug target selection. Our ACE Platform powers multiple products and services to our
customers including: ACE Extended Cancer Panel for DNA, ACE Extended Cancer Panel for RNA, ACE Cancer Research Exome, and ACE Cancer
Research Transcriptome.
Our ACE technology provides coverage of difficult-to-sequence gene regions across all of the approximately 20,000 human genes, filling in key
gaps left by other NGS approaches. ACE technology provides superior and uniform coverage of difficult genomic regions, such as high GC content areas,
and fills gaps and inconsistencies in sequencing to achieve an optimal output. ACE is able to deliver more comprehensive coverage not by simply
generating more data, but by generating higher quality data. We and others have shown in two publications that our ACE technology achieves superior
gene sequencing coverage and finishing.
The substantial majority of our revenues since inception, excluding revenues from the Veteran’s Affairs Million Veteran Program (discussed
below), were derived from ACE Extended Cancer Panel and Cancer Research services.
Oncology Diagnostics
Over time, we expect to work with our biopharmaceutical customers and research collaborators to build evidence of clinical utility for our
platform as a diagnostic for advanced cancer therapies. We see a growing long-term diagnostic opportunity for NeXT as a one-stop, universal tumor
molecular profiling test for cancer patients covering all of the approximately 20,000 human genes compared to the roughly 50 to 500 genes covered by
many currently marketed panels. We have released a diagnostic based on our NeXT Platform that we envision being used in clinical trials with
biopharmaceutical and clinical partners. This product analyzes FFPE tumor samples with our NeXT Platform and returns a CLIA diagnostic report for
physicians that details the therapeutic options for patient-based on the tumor mutations identified from our analysis of the sample. We also see this product
as one that will help us build our internal NeXT database over time.
NeXT Dx Test
In January 2020, we announced the launch of the NeXT Dx Test to help oncologists identify potential therapies and clinical trial options for
cancer patients. The Personalis NeXT Dx Test is one of the first cancer diagnostic platforms to profile approximately 20,000 genes in both the tumor exome
and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few
hundred genes. The Personalis NeXT Dx Test includes advanced analytics to provide a diagnostic report on genetic alterations in medically-important
cancer genes, as well as emerging immunotherapy composite biomarkers of medical importance. Additionally, immunotherapy-related biomarkers such as
microsatellite instability (“MSI”) status and tumor mutational burden (“TMB”) are included in the clinical report. The NeXT Dx Test is targeted to both
leading clinical cancer centers as well as biopharmaceutical companies. No revenues from NeXT Dx were recognized in our fiscal year 2019.
ACE CancerPlus Test
In June 2015, we launched our ACE CancerPlus Test based on a 1,400-gene panel. We built upon this experience by introducing the NeXT Dx
Test described above.
Whole Genome Sequencing
Since 2012, we have been contracted to provide DNA sequencing and data analysis services to the United States Veterans Affair’s (the “VA”)
Million Veteran Program (the “VA MVP”). The VA MVP began collecting samples in 2011 and is a landmark research effort aimed at better understanding
how genetic variations affect health. Up to a million veterans are expected to enroll in the VA MVP study by 2021. With more than 825,000 enrollees to
date, the VA MVP exceeds the enrollment numbers of any single VA study or research program in the past, and is in fact one of the largest population
sequencing efforts in history. In September 2017, we
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entered into a one-year contract with three one-year renewal option periods with the VA for the VA MVP, and received orders under this contract in
September 2017, 2018, and 2019. To date, we have been contracted to deliver approximately 115,000 genome sequence data sets to the VA MVP, and we
expect revenue from the contracts awarded to date to continue into 2021. This relationship with the VA MVP has enabled us to scale our operational
infrastructure and achieve greater efficiencies in our lab. It has also supported our development of industry-leading, large-scale cancer genomic testing. The
substantial experience that we have and expect to continue to develop in whole genome sequencing also optimally positions us for what we anticipate to be
the longer-term strategic direction of the cancer genomics industry, which may include whole genome sequencing of tumors.
The VA MVP program has accounted for a substantial amount of our revenues in recent years, 67% of our total revenues in 2019 and 49% in
2018. In 2017, VA MVP accounted for less than 10% of our revenues.
Personalis is Valuable to Biopharmaceutical Companies
We believe that our platform is valuable to our customers because:
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Our tumor and immune molecular profiling capabilities provide an unprecedented breadth of data from a single limited tumor
sample. We provide information on all of the approximately 20,000 human genes, as well as gene expression, the immune system, and other
elements of cancer biology, in contrast to other currently marketed panels that cover a limited range of roughly 50 to 500 genes and do not
focus on immune cells. The commercial success of immunotherapy drugs has demonstrated the need to better understand the immune
system. Unfortunately, development of new therapies in this category has been challenged by difficulties understanding the precise
interaction between cancer and the immune system. Since our platform provides comprehensive insights on tumor and immune biology,
including in both innate and adaptive immune cells, we believe it will enable drug companies to better understand the biological effect of
therapeutics in patients.
Our platform enhances the opportunity to conduct translational research by analyzing tumor tissues from patients in clinical trials,
rather than animal models or in vitro cancer cell lines, which have historically limited cancer research. While conventional pre-
clinical model systems, such as animal models and cancer cell lines, have been instrumental in early-stage cancer research and drug
development, translation of results to the clinic has been limited and remains a significant barrier to progress, in part because these models
do not sufficiently reflect the complexity of human cancer and the human immune system. Over recent years, tools used to study tissue from
patients have improved and the utilization of tissue from trials has increased. We believe our platform represents the next step in this
transition by further enabling biopharmaceutical companies to address the historical limitations of analyzing patient tissue comprehensively.
The information we provide to personalized cancer therapy companies is used to design therapeutics. Many biopharmaceutical
companies are pursuing personalized cancer therapies, which are designed and manufactured, individually, for each patient based on
genomic alterations in a given patient’s tumor. While there are many potential approaches towards developing these therapies including
neoantigen therapeutics, peptide-based vaccines, RNA and DNA vaccines, virally or bacterially encoded vaccines, and adoptive cell
therapies, all of them benefit from the data and analytics that our platform can generate about a patient’s tumor. We anticipate that drugs
approved based on these therapeutic strategies may specify the use of our platform, enabling us to derive revenue in connection with the
sale of commercial drugs, including the data generation and information processing required to treat each patient. We believe we are
working with the majority of companies developing neoantigen-targeted personalized cancer therapies.
Our enterprise-grade operational infrastructure is scalable, enables rapid turnaround times, and is tailored to meet the unique
workflow needs of our customers. We have invested significant resources to develop an operational infrastructure that allows us to easily
customize our services for each of our customers and scale rapidly to meet their potential research and commercial demands. Moreover, our
infrastructure provides customers with visibility and control over processes, ensures consistency across all components used for the duration
of each clinical trial, is fully traceable for compliance purposes, and allows us to scale while maintaining rapid turnaround times.
• We are developing a complementary liquid biopsy test, which also offers broad 20,000-gene coverage versus more narrowly focused
liquid biopsy tests that are currently available. We have also shown that our technology can analyze DNA obtained from blood plasma,
also known as a liquid biopsy. As with a tissue biopsy, we analyze all of the approximately 20,000 human genes. We are not aware of any
other company developing a cfDNA platform that analyzes all of the approximately 20,000 human genes. We expect this cfDNA to be
obtained by a blood draw concurrently with a tissue sample. Together, the two samples can be used to provide a more comprehensive initial
characterization of the tumor. Additionally, we expect to monitor changes in tumor genetics that arise in response to therapy through serial
measurements using cfDNA samples collected across multiple time points. In 2020, we plan to launch our first liquid biopsy assay designed
to monitor known neoantigens and detect novel neoantigens and tumor escape mechanisms that arise under therapeutic pressure.
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Our Strategy
Our mission is to transform the development of next-generation cancer therapies by providing more comprehensive molecular data about each
patient’s tumor. To achieve this mission, our strategy is to:
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Drive adoption of our platform by establishing and expanding relationships with leading developers of oncology therapeutics. We
believe that we can address the leading companies in oncology therapeutics with a small team of sales representatives and highly targeted
marketing efforts. We augment this team with Ph.D.-level Field Application Specialists that provide deep understanding and expertise in the
areas of oncology and genomics applications, allowing us to develop sciences-based dialog with our customers who are conducting clinical
trials in many parts of their organizations. Once we have completed pilot studies with these customers, we work to expand our footprint by
partnering with them on additional clinical trials using the newest versions of our technology. We plan to continue to enter into such
partnerships and pursue a publication strategy that further demonstrates the utility of our platform.
Invest in new product innovations and enhancements to maintain our leading position. We will continue to make investments in new
products that enhance our platform and further our competitive advantages. As the breadth of data used in drug development and cancer
treatment becomes more and more complex, we believe our biopharmaceutical customers will look to our platform as a complete solution to
drive efficiency in research and development. In 2020 we expect to launch a liquid biopsy test, which also offers broad 20,000-gene
coverage versus the more narrowly focused liquid biopsy tests that are currently available.
Continue to build a body of evidence demonstrating the utility of comprehensive genomic data. We expect the actionable information
that customers gain from our platform will increase demand for our services. We intend to align ourselves with our customers, enabling
them to develop better cancer therapeutics, which in turn demonstrates the utility of our platform. We expect this supportive cycle to
increase our penetration into pharmaceutical and biotechnology enterprises over time.
Continue to grow our relationship with the VA MVP. In addition to providing a stable source of revenue, our relationship with the VA
MVP has enabled us to innovate, scale our operational infrastructure, and achieve greater efficiencies in our lab. The substantial experience
that we have and expect to continue to develop in whole genome sequencing also optimally positions us for what we anticipate to be the
longer-term strategic direction of the cancer genomics industry.
Leverage a growing body of evidence from our platform to develop a diagnostic. It is estimated that over 70% of oncology therapeutics
in development are classified as personalized medicines, which require specific diagnostic testing prior to administration. We see a growing
long-term diagnostic opportunity for NeXT as a one-stop, universal tumor profiling test for cancer patients. We announced the launch of our
NeXT Dx Test in January 2020, which is a clinical diagnostic test based on our ImmunoID NeXT Platform and is one of the first cancer
diagnostic platforms to profile all of the approximately 20,000 genes in both the tumor exome and transcriptome, providing a
comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few hundred genes. NeXT
Dx is targeted initially at leading clinical cancer centers as well as biopharmaceutical companies for use in clinical trials.
Build out a comprehensive tumor-genomics database. We also see a growing long-term opportunity to generate rich databases of content
across a large number of cancer patients. Most current diagnostic based databases built using cancer panels cover just a small fraction of
genes and miss information about the immune system whereas our platform will provide comprehensive information. This database would
serve as a valuable tool to discover new cancer biology, new biomarkers, and potential therapeutic targets. It may include integration with
other sources of RWD, such as electronic health records, which can generate RWE that may be used to reduce risk in early discovery by
helping to identify biomarkers of response, improve trial execution through external control arms, expand indications for therapy, reduce
trial size, and improve trial design.
Our Proprietary Software and Robust Operational Infrastructure
We have invested significant resources to develop an operational infrastructure that allows us to easily customize our services for each of our
customers and scale rapidly to meet their potential research and commercial demands. Our NeXT Platform is complemented by our enterprise-grade
software and bespoke information management systems that we tailor to meet our customers’ unique needs and integrate with their workflows. Moreover,
our infrastructure provides customers with visibility and control over processes, ensures consistency across all components used for the duration of each
clinical trial, is traceable for compliance purposes, and allows us to scale while maintaining rapid turnaround times.
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We designed our proprietary informatics system, the Symphony Enterprise Informatics System (“Symphony”), as a flexible and scalable
enterprise-grade system used to manage the unique complexities and challenges of our genomics laboratory. Symphony integrates laboratory information
management systems (“LIMS”) and bioinformatics systems to connect laboratory operations with downstream data analysis. Symphony orchestrates all
operational activities from our laboratory starting with sample receipt to the reporting of results of the genomic profiling and data delivery. We also use
machine learning and artificial intelligence approaches to generate substantial performance advantages for our algorithms, such as neoantigen binding
prediction.
We are sequencing and analyzing up to 180 trillion bases of DNA per week in our facility. We believe this capacity is already larger than most
cancer genomics companies and we are building the automation and other infrastructure to scale further as demand increases and in support of the planned
2020 launch of our NeXT liquid biopsy assay.
We rely on a limited number of suppliers for sequencers and other equipment and raw materials that we use in our laboratory operations. For
example, we rely on Illumina, Inc. (“Illumina”) as the sole supplier of sequencers and various associated reagents, and as the sole provider of maintenance
and repair services for these sequencers. We have in place certain agreements and purchase arrangements with Illumina to satisfy the needs of our
laboratory operations.
We believe our platform is well positioned to scale rapidly and substantially as the field of personalized cancer therapies matures. We believe that
our platform could be essential to the composition and manufacture of any personalized cancer therapy developed using our platform. Furthermore, we
expect that patients would be tested at multiple time points during the course of treatment: first to design a therapy according to an initial genomic profile
generated from a tissue and/or liquid biopsy, and then as follow-up testing via liquid biopsy to detect any changes that would require therapy modifications
after initial therapeutic interventions. If a therapy that uses our NeXT Platform achieves regulatory approval, we believe that our commercial opportunity
may increase substantially.
We leverage our proprietary software, laboratory automation and protocols, and other operational and technological know how to power our
NeXT Platform.
Our Industry
Over the past decade, the biopharmaceutical community has achieved major advances in the treatment of cancer, including approval of therapies
capable of targeting specific genetic drivers of cancer and novel immunotherapies that empower the immune system to attack cancer cells. Despite these
advances, the substantial majority of currently available cancer therapies have significant limitations, including efficacy only in certain subsets of patients,
limited long-term survival rates, and significant toxicities. Moreover, the current research and development paradigm in oncology is beset by significant
inefficiencies and substantial costs, with the average cost per patient in clinical trials reaching approximately $60,000 (Battelle Technology Partnership
Practice, Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies, March 2015). While tumor molecular profiling technologies
have enhanced research and development efforts, most current tumor biopsy and liquid biopsy tests analyze a relatively narrow set of roughly 50 to 500
tumor genes, missing key genes and immune mechanisms underlying cancer therapy. With the lack of a comprehensive profiling solution,
biopharmaceutical companies often attempt to use a disparate array of tests to compensate, resulting in a fragmented view of the tumor biology, insufficient
tumor sample, logistical complexities, and increased costs. The resulting data heterogeneity makes it difficult to mine for new biological insights across
cohorts of patients in clinical trials. These piecemeal approaches to tumor molecular profiling often result in solutions that are difficult to use at scale,
especially in a clinical or therapeutic setting where simplicity, cost, turnaround time, and validation are important.
Our platform helps biopharmaceutical companies seeking to develop more efficacious therapies by comprehensively interrogating a patient’s
tumor and immune cells in detail, both to discover tumor vulnerabilities and elucidate potential therapeutic alternatives. To meet the demands of our
customers, we built our NeXT Platform to be cost-effective and scalable with rapid turnaround times for tissue sample data and analytics. NeXT represents
the next step of our existing ACE platform, allowing customers to move up the value chain by gaining more information from a single sample. We believe
that our platform has the potential to enable a research, development, and treatment paradigm that is dynamic and adaptive to the evolving genomic and
immune system landscape of patients’ tumors over time. We believe our technology will drive this evolving paradigm, which will ultimately enable our
customers to develop safer and more efficacious therapeutics (see Figure 1). As the clinical utility of our platform increases, we expect to grow our
diagnostic capabilities, including the ability to guide therapy based on a patient’s changing tumor and immune system, and supporting the
commercialization of therapeutics developed by our biopharmaceutical customers.
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Figure 1. Personalis NeXT Platform addresses the increasingly complex understanding of cancer.
Despite the large sums invested in research and despite new treatments, cancer remains a major challenge for modern medicine and a source of
high unmet medical need. According to a 2020 American Cancer Society report, “Cancer Facts & Figures,” as of January 1, 2019, there were more than
16.9 million people in the United States who were suffering from cancer or who had previously suffered from cancer, and more than 1.8 million people
were expected to be diagnosed with the disease in 2020. Cancer prevalence is increasing globally as well. The World Health Organization (the “WHO”)
predicted in its September 2018 estimates on the global prevalence of cancer that there would be 18.1 million new cancer cases and nearly 10 million
cancer deaths globally in 2018. According to the WHO, the total economic impact of healthcare expenditure and loss of productivity resulting from cancer
worldwide was approximately $1.2 trillion in 2010.
Improving Cancer Treatment is Increasingly About Leveraging Molecular Data
Despite the rapid evolution of cancer therapies, the current research and development paradigm in oncology is beset by significant inefficiencies
and costs. Cancer therapeutics have one of the lowest clinical trial success rates of all major diseases. According to a study of 7,455 drug development
programs during 2006 to 2015, the overall likelihood of FDA approval from Phase I clinical trial for oncology developmental candidates was 5.1% (BIO
Industry Analysis, Clinical Development Success Rates 2006-2015, June 2016). The majority of currently available cancer therapeutics have serious
limitations, including efficacy only in certain subsets of patients, limited long-term survival rates, and significant toxicities. The mechanisms underlying the
success or failure of clinical trials are often poorly understood. To develop more efficacious cancer treatments, the biopharmaceutical community is faced
with multiple key questions for a given therapeutic approach:
Are there additional therapeutic targets or alternative pathways that can improve outcomes?
• Why do some patients respond to treatment and others do not?
• What are the underlying mechanisms of treatment resistance?
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• What therapeutic combinations can improve outcomes?
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Are there ways to increase patient response through personalized therapeutics?
Are there ways to reduce toxicity?
There is a growing recognition that there is a tremendous amount of untapped molecular data that can be derived from analyzing tumors from
large numbers of cancer patients, whether in cancer clinical trials or post-commercialization, that can help answer some of these seminal questions and
accelerate therapeutic development. The threefold increase in probability of FDA approval from Phase I clinical trial for therapies with biomarkers across
all diseases and therapeutic types provides an indication of the benefits of leveraging molecular data.
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Current Tumor Molecular Profiling Solutions Have Not Kept Pace with New Cancer Therapies
Biopharmaceutical companies are increasingly turning to tumor molecular profiling across large cohorts of patients to generate the data needed
to answer these questions. Unfortunately, current tumor molecular profiling methods have not kept pace with new therapy development and overlook
crucial elements of our evolving understanding of cancer biology.
Current tumor molecular profiling falls short for new cancer immunotherapies
Most current tumor molecular profiling panels were designed with a focus on targeted therapies, which, along with chemotherapy, have been
used for cancer treatment for the past several decades. Targeted therapies treat cancers based on the specific genomic alterations driving their growth. Some
targeted therapies have been developed to target specific molecules that are overexpressed or mutated in cancer cells. Because targeted therapies focus on
cancer driver genes, the vast majority of tumor molecular profiling panels today, whether tissue or liquid biopsy based, typically sequence the DNA of
between 50 to 500 genes, just a small fraction of the approximately 20,000 human genes.
Recently, however, transformational new approaches to cancer therapy that have been developed to harness the patient’s own immune system
have changed the treatment paradigm and our understanding of cancer biology. These new immunotherapies have dramatically improved the treatment of
certain tumors that have previously been difficult to treat. Among these new immunotherapies, checkpoint inhibitors of the CTLA-4 and PD-1/PD-L1
genes are particularly effective. These therapies help “take the brakes off” the immune system and elicit a stronger immune response against the tumor.
Patients can also be treated by adoptive cell therapy, in which the patient’s immune system is supplemented with cytotoxic cells that have been
programmed to attack cells expressing specific antigens on their tumors. There are also new opportunities for personalized cancer therapies where a new
therapeutic vaccine or cell therapy is developed for each patient. Despite early success, the majority of patients today still do not respond to
immunotherapy, underscoring the importance of gathering data that can help biopharmaceutical companies understand factors governing response and
resistance to therapy.
With these new immunotherapies and our rapidly evolving understanding of cancer biology, we believe the data needed to inform therapeutic
development goes far beyond the typical 50 to 500 genes on current tumor molecular profiling panels. The paradigm has shifted from the need to
understand mechanisms behind a single gene target to a dynamic, systems biology view involving complex interactions between thousands of genes in the
tumor and the immune system in the pathogenesis of cancer and cancer drug response.
Information about all of the approximately 20,000 human genes allows deeper insight into the biology of cancer, identifying novel or patient-
specific therapeutic targets, including neoantigens, and predictive biomarkers of response to therapy. Understanding the immune cell signatures in the
tumor microenvironment and immune repertoire changes is critical for understanding drug response. In addition to DNA, comprehensive RNA expression
information from the tumor is needed to analyze complex pathways that may be activated in the tumor. It is important to identify the increasingly complex
mechanisms of tumor response and resistance to cancer therapy, such as neoantigen burden, tumor antigens, deficient antigen presentation, oncogenic
pathways, immune evasion pathways, HLA mutations, T-cell clonality, immune infiltration, and others. Table 1 describes some of the biological gaps in
current panels. Most of these elements go beyond the capabilities of today’s tumor molecular profiling panels.
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Table 1. Most current tumor tissue and liquid biopsy profiling panels miss critical tumor and immune biology.
Fragmented tumor molecular profiling approaches result in a fragmented view of biology and limited insights
With the lack of a comprehensive profiling solution, biopharmaceutical companies often turn to fragmented, piecemeal approaches to tumor
molecular profiling as a stopgap measure. Those fragmented tumor molecular profiling approaches lead to major problems for therapeutic development.
Limitations in available tumor samples, including liquid biopsies, force scientists to pick and choose which profiling platforms to include and which to
omit, resulting in a fragmented picture of the biology. Fragmented profiling solutions also result in inconsistent profiling from patient to patient, and
clinical trial to clinical trial. This results in data heterogeneity that makes it difficult to mine for new biological insights across cohorts of patients in trials.
Finally, these piecemeal approaches to tumor molecular profiling result in solutions that often are difficult to use at scale in a clinical or therapeutic setting
where logistical simplicity, cost, turnaround time, and validation are important.
Current tumor molecular profiling panels can become antiquated with evolving science
With the explosion of immunotherapy and advances in our understanding of cancer, new insights into the underlying mechanisms of response
and resistance have emerged. New putative genetic or immune biomarkers of response are regularly identified for different therapies in the context of
different cancers. For instance, new biomarkers have been identified including tumor mutational burden, neoantigens, HLA type, B2M mutations, TGFß,
JAK1/JAK2 mutations, expression signatures, cytotoxicity signatures, and T-cell clonality, among others. A recent Nature Medicine review identified 18
different categories of biomarkers correlating with immunotherapy response spanning tumor, immune cells, and the tumor microenvironment. Due to the
limited coverage of most cancer panels, they may miss new biomarkers. We believe this problem will continue as research uncovers new insights into
cancer.
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Sequencing Quality and Coverage
Next generation sequencing (“NGS”) is the technological basis for many tumor molecular profiling platforms today. NGS rapidly sequences
nucleic acids and then uses a computationally intensive process to reconstruct gene sequences from millions of short sequence segments. These segments
are processed in parallel, an approach that greatly increases the speed that the sequence data can be generated. However, because the segments come from
random locations in the genome, reassembling the original sequence is both a technically and computationally challenging process. A key objective is to
ensure that every portion of the genes being sequenced is covered by at least one sequence segment. The average number of sequence segments
representing a gene is referred to as the sequence depth. The deeper the coverage, the greater fraction of the gene is likely to be covered and the higher
confidence that low-frequency variants can be found.
However, even when sequenced to high depth, typical NGS approaches can leave uneven, poor coverage in genes with mutations linked to
cancer and cancer therapy. Many of these regions cannot be fully covered by simply sequencing to higher depth because their sequencing coverage deficits
are due to inherent limitations of the NGS platform. Regions of high guanine-cytosine (“GC”) content or repetitive sequence regions are two such examples
of regions that are difficult to cover with standard NGS assays. This can leave gaps in coverage of therapeutically important genes. This is particularly
problematic in cancer, where there can be significant heterogeneity in the tumor samples that can make it even harder to see mutations in regions of poor
coverage.
To address the limitations of typical NGS-based assay, we have developed our patented ACE technology for next-generation sequencing. ACE
improves nucleic acid preparation processes and combines it with patented assay and sequencing methods to achieve superior, high-fidelity, clinical-grade
sequencing quality that ensures high sensitivity for mutations that can inform clinical and therapeutic applications such as neoantigen prediction, biomarker
identification, and novel drug target selection.
Our NeXT Platform uses our ACE technology to provide coverage of difficult-to-sequence gene regions across all of the approximately 20,000
human genes, filling in key gaps left by other NGS approaches. ACE technology provides superior and uniform coverage of difficult genomic regions, such
as high GC content areas, and fills gaps and inconsistencies in sequencing to achieve an optimal output. ACE is able to deliver more comprehensive
coverage not by simply generating more data, but by generating higher quality data. We and others have shown in two publications that our ACE
technology achieves superior gene sequencing coverage and finishing.
Commercialization Strategy
We commercialize our products in the United States and Europe through our targeted sales organization. In 2019, we derived substantially all of
our revenues from our customers in the United States. Our sales representatives have extensive experience in enterprise/consultative selling in the genomics
space. We augment this team with Ph.D.-level Field Application Specialists that provide deep understanding and expertise in the areas of oncology and
genomics applications, ensuring top-quality pre- and post-sales customer support. Our commercial efforts are focused on demonstrating the value
proposition of the NeXT Platform to biopharmaceutical customers with the goal of both increasing utilization of the product at existing accounts and to
drive adoption in new targeted accounts. Our entire commercial organization promotes our ability to support biopharmaceutical customers across several
application areas including biomarker discovery, new target discovery, therapy development, and treatment monitoring.
We anticipate that patients in clinical trials for cancer therapies will increasingly be tested pre-treatment and periodically afterwards to
understand response to treatment in deep molecular detail, as their tumors evolve under therapeutic pressure. Although the majority of our revenues come
from single time point testing, we believe our revenues from multiple time point testing will continue to grow. We also derive revenues from analysis of
multiple customer samples from the same patient and time point to assess genetic differences between the primary tumor and metastases. Given the value
of comprehensive genomic information from multiple time points or samples, we anticipate that our revenue, and the available market, will continue to
grow.
As the clinical utility of advanced biomarkers is further established, we expect there to be a patient-centered diagnostic opportunity whereby
some patients would be guided to personalized therapies. We believe that our platform’s ability to support biomarkers for a broad range of therapeutics
positions us to be a leader in therapy selection for patients. We announced the launch of our NeXT Dx Test in January 2020, which is a clinical diagnostic
test based on our ImmunoID NeXT Platform and is one of the first cancer diagnostic platforms to profile all of the approximately 20,000 genes in both the
tumor exome and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus
on a few hundred genes. NeXT Dx is targeted initially at leading clinical cancer centers as well as biopharmaceutical companies for use in clinical trials.
Our Customers
Since inception, we have provided our services to more than 50 biopharmaceutical customers, including several of the largest pharmaceutical
companies in the world. We have also provided our services to universities and non-profits, diagnostics companies, and government entities. Some of our
announced customers include Pfizer Inc., Merck & Co., Inc., and Indivumed GmbH.
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In 2019, VA MVP and Pfizer Inc. accounted for 67% and 13% of our revenues, respectively. No other customer accounted for 10% or more of
our revenues. In 2018, we had three customers account for 10% or more of our revenues: VA MVP at 49%, Merck & Co., Inc. at 12%, and Pfizer Inc. at
10%. In 2017, Merck & Co., Inc. accounted for 11% of our revenues while two other customers also contributed 10% or more of our revenues.
Our Competition
We provide a comprehensive, exome-scale analysis of both a tumor and its microenvironment, including the immune cells, from a single tissue
sample.
Our primary competition comes from companies offering genomic profiling services for either the tumor or the immune microenvironment.
These companies offer services that implement various technological approaches including next-generation sequencing and microarray analyses. These
competitors include Guardant Health, Inc., Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in July 2018, Roche Molecular
Systems, Inc., NanoString Technologies, Inc., Personal Genome Diagnostics, Inc., and Adaptive Biotechnologies Corporation.
Competitors within the broader genomics profiling space include laboratory companies such as Laboratory Corporation of America Holdings,
Quest Diagnostics, Inc., Caris Life Sciences, Inc., Myriad Genetics, Inc., Tempus, Inc., InVitae Corp., BGI Group, Macrogen, Inc., Natera, Inc., Illumina,
Thermo Fisher Scientific Inc., NeoGenomics, Inc., and MedGenome Inc., as well as other companies that provide sequencing services to biopharmaceutical
companies. Additionally, several companies develop next-generation sequencing platforms that can be used for genomic profiling for biopharmaceutical
research and development applications. These include Illumina, Thermo Fisher Scientific Inc., and other organizations that specialize in the development of
next-generation sequencing instrumentation that can be sold directly to biopharmaceutical companies, clinical laboratories, and research centers. Separate
from their instrumentation product lines, both Illumina and Thermo Fisher Scientific Inc., for example, currently market next-generation sequencing
clinical oncology kits that are sold to customers who have bought and operate their respective sequencing instruments.
We believe that we compete favorably because of the integrity and comprehensiveness of the data generated by our NeXT Platform. Maximizing
insights into both the tumor- and immune-related components of the tumor microenvironment is essential in identifying and understanding the reasons why
certain cancer patients respond more favorably to oncology therapies than others. It is via access to such a comprehensive dataset for each patient that our
customers can begin to discover new, clinically relevant biomarkers for the immunotherapy era, and ultimately improve cancer patient outcomes with the
development of more efficacious therapeutics.
Intellectual Property
Protection of our intellectual property is fundamental to the long-term success of our business. Specifically, our success is dependent on our
ability to obtain and maintain proprietary protection for our technology and the know-how related to our business, defend and enforce our intellectual
property rights, and operate our business without infringing, misappropriating, or otherwise violating valid and enforceable intellectual property rights of
others. We seek to protect our investments made into the development of our technology by relying on a combination of patents, trademarks, copyrights,
trade secrets, know-how, confidentiality agreements and procedures, non-disclosure agreements with third parties, employee disclosure and invention
assignment agreements, and other contractual rights.
Our patent strategy is focused on seeking coverage for our core technology, our ACE assay, and specific follow-on applications and
implementations for enhancing sequencing coverage of certain genomic regions and analyzing cell-free nucleic acids. In addition, we file for patent
protection on our ongoing research and development, particularly other novel assay technologies which may be applicable in cancer cases and other
diseases.
Notwithstanding these efforts, we cannot be sure that patents will be granted with respect to any patent applications we have filed or may license
or file in the future, and we cannot be sure that any patents we have or may be licensed or granted to us in the future, will not be challenged, invalidated, or
circumvented, or that such patents will be commercially useful in protecting our technology. Moreover, we rely, in part, on trade secrets to protect aspects
of our business that are not amenable to, or that we do not consider appropriate for, patent protection. However, trade secrets can be difficult to protect.
While we take steps to protect and preserve our trade secrets, including by entering into confidentiality agreements with our employees, consultants,
scientific advisors, and contractors, and maintaining physical security of our premises and physical and electronic security of our information technology
systems, such measures can be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become
known or be independently discovered by competitors. For more information regarding the risks related to our intellectual property, please see “Risk
Factors—Risks Related to Our Intellectual Property.”
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Our patent portfolio is comprised of patents and patent applications owned by the company. These patents and patent applications generally fall
into four broad categories:
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our ACE assay technology, including claims directed to methods for enriching sample nucleic acids based on differences in GC-content,
molecular size, presence of genetic variations or rearrangements, epigenetic modifications, and species-origin (e.g., human and non-human);
hybrid exome-genome technologies, including claims directed to methods for combining exome and genome sequencing data generated
from a sample to identify polymorphisms;
liquid biopsy methods, including claims directed to methods of analyzing sequenced cell-free and leukocyte-derived nucleic acids in a blood
sample to identify a tissue source, or recommend a drug treatment; and
clinical interpretation methods, including claims directed to methods of ranking genes associated with a phenotype and inheritance pattern.
As of December 31, 2019, we own twelve issued U.S. and foreign patents in China and the United Kingdom and several pending U.S. and
foreign patent applications. Issued U.S. patents in our portfolio of company-owned patents and patent applications are expected to expire between 2033 and
2037, excluding any additional term for patent term adjustments or patent term extensions.
Government Regulations
Federal and State Laboratory Licensing Requirements
Under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), a laboratory is any facility that performs laboratory testing on
specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease, or the impairment of or
assessment of health. CLIA requires that a laboratory hold a certificate applicable to the type of laboratory examinations it performs and that it complies
with, among other things, standards covering operations, personnel, facilities administration, quality systems and proficiency testing, which are intended to
ensure, among other things, that clinical laboratory testing services are accurate, reliable and timely.
To renew our CLIA certificate, we are subject to survey and inspection every two years to assess compliance with program standards. Because
we are a College of American Pathologists (“CAP”) accredited laboratory, the Centers for Medicare & Medicaid Services (“CMS”) does not perform this
survey and inspection and relies on our CAP survey and inspection. We also may be subject to additional unannounced inspections. Laboratories
performing high complexity testing are required to meet more stringent requirements than laboratories performing less complex tests. In addition, a
laboratory that is certified as “high complexity” under CLIA may develop, manufacture, validate, and use proprietary tests referred to as laboratory
developed tests (“LDTs”). CLIA requires analytical validation including accuracy, precision, specificity, sensitivity, and establishment of a reference range
for any LDT used in clinical testing. The regulatory and compliance standards applicable to the testing we perform may change over time, and any such
changes could have a material effect on our business.
CLIA provides that a state may adopt laboratory regulations that are more stringent than those under federal law, and a number of states have
implemented their own more stringent laboratory regulatory requirements. State laws may require that nonresident laboratories, or out-of-state laboratories,
maintain an in-state laboratory license to perform tests on samples from patients who reside in that state. As a condition of state licensure, these state laws
may require that laboratory personnel meet certain qualifications, specify certain quality control procedures or facility requirements, or prescribe record
maintenance requirements. Because our laboratory is located in the state of California, we are required to and do maintain a California state laboratory
license. We also maintain licenses to conduct testing in other states where nonresident laboratories are required to obtain state laboratory licenses. We
maintain a current license with the New York State Department of Health for our laboratory. Other states may currently have or adopt similar licensure
requirements in the future, which may require us to modify, delay, or stop its operations in those states.
Regulatory framework for medical devices in the United States
Pursuant to its authority under the Federal Food, Drug and Cosmetic Act (the “FDC Act”), the FDA has jurisdiction over medical devices, which
are defined to include, among other things, in vitro diagnostic devices (“IVDs”). The FDA regulates, among other things, the research, design,
development, pre-clinical and clinical testing, manufacturing, safety, effectiveness, packaging, labeling, storage, recordkeeping, pre-market clearance or
approval, adverse event reporting, marketing, promotion, sales, distribution, and import and export of medical devices. Unless an exemption applies, each
new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the
FDA requesting permission for commercial distribution under Section 510(k) of the FDC Act, also referred to as a 510(k) clearance, or approval from the
FDA of a PMA. Both the 510(k) clearance and PMA processes can be resource intensive, expensive, and lengthy, and require payment of significant user
fees.
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Although the FDA regulates medical devices, including IVDs, the FDA has historically exercised its enforcement discretion and not enforced
applicable provisions of the FDC Act and FDA regulations with respect to LDTs, which are a subset of IVDs that are intended for clinical use and
developed, validated, and offered within a single laboratory for use only in that laboratory. We currently intend to market a diagnostic test based on the
NeXT Platform as an LDT. As a result, we believe our diagnostic services are not currently subject to the FDA’s enforcement of its medical device
regulations and the applicable FDC Act provisions.
Federal and State Fraud and Abuse Laws
We are subject to federal fraud and abuse laws such as the federal Anti-Kickback Statute (the “AKS”), the federal prohibition against physician
self-referral (the “Stark Law”), and the federal false claims law, or the False Claims Act (the “FCA”). We are also subject to similar state and foreign fraud
and abuse laws.
The AKS prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly,
overtly or covertly, in cash or in kind, in return for or to induce such person to refer an individual, or to purchase, lease, order, arrange for, or recommend
purchasing, leasing, or ordering, any good, facility, item, or service that is reimbursable, in whole or in part, under a federal healthcare program.
The Stark Law and similar state laws, including California’s Physician Ownership and Referral Act, generally prohibit, among other things,
clinical laboratories and other entities from billing a patient or any governmental or commercial payer for any diagnostic services when the physician
ordering the service, or any member of such physician’s immediate family, has a direct or indirect investment interest in or compensation arrangement with
us, unless the arrangement meets an exception to the prohibition.
Other federal fraud and abuse laws to which we are subject include, but are not limited to, the federal civil and criminal false claims laws
including the FCA, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or
fraudulent claim for payment to the federal government, and the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or
transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s
selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies.
Under the FCA, private citizens can bring claims on behalf of the government through qui tam actions. We must also operate within the bounds of the fraud
and abuse laws of the states in which we do business which may apply to items or services reimbursed by non-governmental third-party payers, including
private insurers.
Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve
substantial costs. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be
subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government-funded healthcare programs,
such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, additional reporting, or
oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and
the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we do business is found to be
not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from
government-funded healthcare programs.
HIPAA and HITECH
Under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended
by the Health Information Technology for Economic and Clinical Health Act “HITECH”), the U.S. Department of Health and Human Services (“HHS”)
issued regulations that establish uniform standards governing the conduct of certain electronic healthcare transactions and requirements for protecting the
privacy and security of protected health information (“PHI”), used or disclosed by covered entities and business associates. Covered entities and business
associates are subject to HIPAA and HITECH. Our subcontractors that create, receive, maintain, transmit, or otherwise process PHI on behalf of us are
HIPAA “business associates” and must also comply with HIPAA as a business associate.
HIPAA and HITECH include privacy and security rules, breach notification requirements, and electronic transaction standards.
The Privacy Rule covers the use and disclosure of PHI by covered entities and business associates. The Privacy Rule generally prohibits the use
or disclosure of PHI, except as permitted under the Rule. The Privacy Rule also sets forth individual patient rights, such as the right to access or amend
certain records containing his or her PHI, or to request restrictions on the use or disclosure of his or her PHI.
The Security Rule requires covered entities and business associates to safeguard the confidentiality, integrity, and availability of electronically
transmitted or stored PHI by implementing administrative, physical, and technical safeguards. Under HITECH’s Breach Notification Rule, a covered entity
must notify individuals, the Secretary of the HHS, and in some circumstances, the media of breaches of unsecured PHI.
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In addition, we may be subject to state health information privacy and data breach notification laws, which may govern the collection, use,
disclosure, and protection of health-related and other personal information. California, for example, has enacted the Confidentiality of Medical Information
Act, which sets forth standards in addition to HIPAA and HITECH with which all California health care providers like us must abide. State laws may be
more stringent, broader in scope, or offer greater individual rights with respect to PHI than HIPAA, and state laws may differ from each other, which may
complicate compliance efforts.
Entities that are found to be in violation of HIPAA as the result of a failure to secure PHI, a complaint about our privacy practices or an audit by
HHS, may be subject to significant civil and criminal fines and penalties and additional reporting and oversight obligations if such entities are required to
enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance.
U.S. Healthcare Reform
In the United States, there have been a number of legislative and regulatory changes at the federal and state levels that seek to reduce healthcare
costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care
and Education Reconciliation Act (collectively, the “ACA”), became law. This law substantially changed the way health care is financed by both
commercial payers and government payers, and significantly impacted our industry. The ACA contained a number of provisions expected to impact the
clinical laboratory industry, such as changes governing enrollment in state and federal health care programs, reimbursement changes, and fraud and abuse.
Some of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects of
the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has
signed two executive orders and other directives designed to delay the implementation of certain provisions of the ACA. Concurrently, Congress has
considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it
has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s
individual mandate to carry health insurance and delaying the implementation of certain ACA-mandated fees. On December 14, 2018, a Texas U.S. District
Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and
Jobs Act of 2017. While the Texas U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will have no
immediate effect pending appeal of the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will
impact the ACA.
We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial payers to reduce
costs while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge
for our tests, the coverage of or the amounts of reimbursement available for our tests from payers, including commercial payers and government payers.
Material Agreements
VA MVP Agreement
On September 28, 2017, we entered into a contract with the VA for the VA MVP to provide them with a combination of whole genome
sequencing services (the “VA MVP Agreement”). The performance period for the services includes a base period of one year (September 2017 to August
2018), with three one-year renewal option periods that may be exercised upon discretion of the VA MVP (September 2018 to August 2019; September
2019 to August 2020; and September 2020 to August 2021). Each task order issued against the VA MVP Agreement has a separate period of performance
and is subject to the terms and conditions of the VA MVP Agreement. Funds are obligated by the VA MVP under each task order based on actual needs. To
date, the VA MVP has exercised two of its three one-year renewal options, meaning that our current task order extends through August 2020.
All materials and samples utilized during the course of the VA MVP Agreement and all data first produced or delivered under the VA MVP
Agreement are the sole property of the VA MVP. Under the VA MVP Agreement, we are subject to confidentiality and security obligations, as well as
various obligations upon events of default.
The VA MVP may terminate the VA MVP Agreement, or any part thereof, at its sole convenience. Subject to the terms of the VA MVP
Agreement, we shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus
reasonable charges that we can demonstrate have resulted from the termination.
The VA MVP may terminate the VA MVP Agreement, or any part thereof, for cause in the event of any default by us, or if we fail to comply
with any contract terms and conditions, or fail to provide the VA MVP, upon request, with adequate assurances of future performance. In the event of
termination for cause, the VA MVP shall not be liable to us for any amount for supplies or services not accepted, and we shall be liable to the VA MVP for
any and all rights and remedies provided by law. If it is determined that the VA MVP improperly terminated this contract for default, such termination shall
be deemed a termination for convenience.
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Agreements with Illumina
On March 21, 2017 we received a quotation for supply of genetic analysis products (the “Quote”) from Illumina. The Quote provided
information as to the cost of five Illumina® Product Care NovaSeq®6000 Comprehensive Plans and five NovaSeq™6000 Sequencing System instruments.
The term of the Quote extended through March 31, 2017. On March 31, 2017, we submitted a purchase order to Illumina for five NovaSeq™6000
Sequencing System instruments, all of which we have received. On March 1, 2019, we received another quotation for supply of genetic analysis products
(the “Second Quote”) from Illumina. The Second Quote provided information as to the cost of five NovaSeqTM6000 Sequencing System instruments. The
term of the Second Quote extended through March 31, 2019. On March 20, 2019, we submitted a purchase order to Illumina for five NovaSeqTM6000
Sequencing System instruments, four of which we have received and one of which will be received on or before the due date of March 23, 2023.
On November 1, 2017, we entered into a master services subcontract agreement (the “Subcontract Agreement”) with Illumina. Under the terms
of the Subcontract Agreement, we engaged Illumina as our subcontractor to perform certain genotyping services (the “Services”) on our behalf pursuant to
written purchase orders in fulfillment of our VA MVP Agreement. The price for Illumina’s Services set forth in the Subcontract Agreement is effective
through December 31, 2021, or later if the VA MVP Agreement is extended.
The Subcontract Agreement extends through the last day of the VA MVP Agreement, currently August 2021 but as may be extended, unless it is
otherwise terminated early pursuant to its terms. All or part of the Subcontract Agreement may be terminated at our convenience in the event that the VA
MVP terminates the VA MVP Agreement or terminates the part of the VA MVP Agreement that affects the Services provided by Illumina. Each party may
terminate the Subcontract Agreement for default in the event that the other party materially fails to perform any of the provisions of the Subcontract
Agreement, materially fails to make progress so as to endanger performance of the Subcontract Agreement in accordance with its terms, or becomes
financially or legally incapable of completing the work and does not provide a plan of correction or recovery within the provided period of time to cure
such failure. The Subcontract Agreement may be renewed for subsequent one-year terms as agreed by the parties subject to a four-year limit.
On November 22, 2017, we entered into a pricing agreement with Illumina. The pricing agreement provided pricing terms for the NovaSeq™
5000/6000 S4 Reagent Kit (each, a “Kit”). On March 26, 2019, we entered into a new pricing agreement with Illumina, which replaced in its entirety the
agreement dated November 22, 2017. The new pricing agreement had a purchase commitment of $1.7 million by June 30, 2019 to purchase these Kits,
which we fulfilled in the ordinary course of business. The term of the pricing agreement extends through December 31, 2022.
On December 13, 2017, we received a Fast Track genetic analysis services agreement (the “Services Agreement”) from Illumina that provided
pricing information for the Infinium Global Screening Array V2.0 Fast Track Service, a service we used to fulfill one of our VA MVP task orders. The term
of the Services Agreement extended through June 30, 2019. Illumina continues to provide us similar genotyping Fast Track services that we use to fulfill
our VA MVP task orders, but such services are now pursuant to Illumina’s standard terms and conditions rather than a separate services agreement.
On February 22, 2019 we received a quotation for supply of genetic analysis products (the “Master Quote”) from Illumina that provides for
additional pricing terms on Illumina products, which was updated on November 19, 2019. The term of the Master Quote extends through December 31,
2020.
Our Employees
As of December 31, 2019, we had 182 employees, of which 181 were full-time employees. Of these full-time employees, 71 were in research
and development, 56 in laboratory operations, 29 in commercial operations and 25 in general and administrative functions. 177 of our full-time employees
are located in the United States (including 158 who work at our corporate headquarters in Menlo Park, California and 19 who work remotely) and 4 are
located in Europe. As of December 31, 2019, more than 75 of our employees had completed a Ph.D. or other advanced science or medical degree.
None of our employees are represented by a labor union or covered by collective bargaining agreements, and we have not experienced any work
stoppages. We consider our relations with our employees to be good.
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Our Facilities
Our corporate headquarters are located in Menlo Park, California, and comprise approximately 31,280 square feet of space, pursuant to an
operating lease that expires in 2020. This lease includes an option to extend for an additional three years, at market rates that prevail at the time of our
election to extend. Our CLIA-certified laboratory is located in this facility.
We believe that this facility is sufficient to meet our current needs. We also believe we will be able to obtain additional space, as needed, on
commercially reasonable terms.
Available Information
Our website is located at https://www.personalis.com. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, including their exhibits, proxy and information statements, and amendments to those reports filed or furnished pursuant to Sections 13(a), 14,
and 15(d) of the Securities Exchange Act of 1934, as amended, are available through the “Investors” portion of our website free of charge as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Information on our website is not part of this Annual Report
on Form 10-K or any of our other securities filings unless specifically incorporated herein or therein by reference. In addition, our filings with the SEC may
be accessed through the SEC’s Interactive Data Electronic Applications system at http://www.sec.gov. All statements made in any of our securities filings,
including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume
or undertake any obligation to update any of those statements or documents unless we are required to do so by law.
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Item 1A. Risk Factors.
Our operations and financial results are subject to various risks and uncertainties including those described below. You should consider
carefully the risks and uncertainties described below, in addition to other information contained in this Annual Report on Form 10-K, including our
consolidated financial statements and related notes. The risks and uncertainties described below are not the only ones we face. Additional risks and
uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. If
any of the following risks or others not specified below materialize, our business, financial condition and results of operations could be materially and
adversely affected. In that case, the trading price of our common stock could decline.
Risks Related to Our Business and Strategy
We have a history of losses, and as our costs increase, we expect to incur significant losses for the foreseeable future and may not be able to
generate sufficient revenues to achieve or sustain profitability.
We have incurred net losses since our inception. For the years ended December 31, 2019, 2018, and 2017 we had net losses of $25.1 million,
$19.9 million, and $23.6 million, respectively. As of December 31, 2019, we had an accumulated deficit of $140.6 million. To date, we have not generated
sufficient revenues to achieve profitability, and we may never achieve or sustain profitability. In addition, we expect to continue to incur net losses for the
foreseeable future, and we expect our accumulated deficit to continue to increase as we focus on scaling our business and operations. Our efforts to sustain
and grow our business may be more costly than we expect, and we may not be able to increase our revenues sufficiently to offset our higher operating
expenses. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
Our failure to achieve and sustain profitability in the future would negatively affect our business, financial condition, results of operations, and cash flows,
and could cause the market price of our common stock to decline.
If we are unable to increase sales of our current services or successfully develop and commercialize other services or products, or if we are
unable to execute our sales and marketing strategy for our services or unable to gain sufficient acceptance in the market, we may fail to
generate sufficient revenues to achieve profitability and sustain our business.
We currently derive substantially all of our revenues from sales of our services. We began offering our services through our Clinical Laboratory
Improvement Amendments of 1988 (“CLIA”)-certified, College of American Pathologists (“CAP”)-accredited, and state-licensed laboratory in 2013. We
are in varying stages of research and development for other services and products that we may offer. If we are unable to increase sales of our existing
services or successfully develop and commercialize other services and products, we will not generate sufficient revenues to become profitable.
In addition, as a growing genomics company, we have engaged in targeted sales and marketing activities for our services. Although we have had
revenues from sales of our services since 2013, our services may never gain significant acceptance in the marketplace and therefore may never generate
substantial revenues or permit us to become profitable. We will need to further establish and grow the market for our services through the expansion of our
current relationships and development of new relationships with biopharmaceutical customers. Gaining acceptance in medical communities can be
supported by, among other things, publications in leading peer-reviewed journals of results from studies using our services. The process of publication in
leading medical journals is subject to a peer review process and peer reviewers may not consider the results of our studies sufficiently novel or worthy of
publication. Failure to have our studies published in peer-reviewed journals would limit the adoption of our services.
Our ability to successfully market our services that we have developed, and may develop in the future, will depend on numerous factors,
including:
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our ability to demonstrate the utility and value of our services to our customers;
the success of our sales force;
whether biopharmaceutical companies accept that our services are sufficiently sensitive and specific;
our ability to convince biopharmaceutical companies of the utility of the comprehensiveness of our services and of testing patients at
multiple time points;
our ability to continue to fund sales and marketing activities;
whether our services are considered superior to those of our competitors;
any negative publicity regarding our or our competitors’ services resulting from defects or errors;
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our success obtaining and maintaining patent and trade secret protection for our services and technologies; and
our success enforcing and defending intellectual property rights and claims.
Failure to achieve broad market acceptance of our services would materially harm our business, financial condition, and results of operations.
Our operations and employees face risks related to health crises, such as the ongoing COVID-19 pandemic, that could adversely affect our
financial condition and operating results. The COVID-19 pandemic could materially affect our operations, including at our headquarters in
the San Francisco Bay Area, which is currently subject to shelter-in-place orders, and the business or operations of our manufacturers,
customers or other third parties with whom we conduct business.
Our business could be adversely impacted by the effects of a health crisis, such as the ongoing COVID-19 outbreak and could cause significant
disruption in the operations of our customers and third-party manufacturers upon whom we rely. Our sole laboratory, executive team, and most of our
employees are located in the San Francisco Bay Area. In the event of a health crisis that becomes widespread in or around the San Francisco Bay Area, we
may proactively, or be ordered by government officials to, take precautionary measures such as suspending our lab operations, implementing alternative
work arrangements for our employees, and limiting our employees’ travel activities. For example, in December 2019, a novel strain of coronavirus, SARS-
CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread to over 140
countries, including the United States. On March 10, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic, and the U.S.
government imposed restrictions on travel between the United States and Europe for a 30-day period. Further, on March 13, 2020, the President of the
United States declared the COVID-19 pandemic a national emergency, invoking powers under the Stafford Act, the legislation that directs federal
emergency disaster response. On March 4, 2020, the State of California declared a state of emergency related to the spread of COVID-19, and the San
Francisco Department of Public Health announced aggressive recommendations to reduce the spread of the disease, including recommendations to suspend
nonessential travel, encourage telecommuting, and cancel or postpone large gatherings. On March 16, 2020, the health officers of six San Francisco Bay
Area counties, including San Mateo County where our headquarters and sole laboratory are located, issued shelter-in-place orders that took effect at 12:01
a.m., Pacific Time, on March 17, 2020 and remain in force until April 7, 2020, (i) directing all individuals living in those counties to shelter at their places
of residence (subject to limited exceptions), (ii) directing all businesses and governmental agencies to cease non-essential operations at physical locations
in those counties, (iii) prohibiting all non-essential gatherings of any number of individuals, and (iv) ordering cessation of all non-essential travel. While
the order allows for continued operation of so-called Essential Businesses, which includes certain critical healthcare operations and services, we have
substantially closed our office space and limited access to our laboratory space, to protect our employees and to comply with the provisions described
within the order, and we are prioritizing the fulfillment of customer orders to those related to time-sensitive healthcare projects, such as in-process clinical
trials, and will fulfill other customer orders to the extent we have the ability to do so with limited laboratory staffing. The effect of the shelter-in-place order
may negatively impact productivity and disrupt our business, and may disrupt the ability of our suppliers to fulfill our purchase orders in a timely manner
or at all. Several of our customers have been delayed in sending us samples, and the order may disrupt additional customers from sending purchase orders
and samples to us as they implement their own precautionary measures. Many of our customers, potential customers and potential partners have also put in
place policies restricting visitors from other companies, and therefore our sales team and members of management have been unable to meet such parties in
person, which may result in reduced acquisition of new customers, fewer orders from existing customers and fewer potential partnering opportunities. Such
disruptions in our operations, and our customers’ and suppliers’ operations, may adversely affect our financial condition and operating results. In addition,
on March 19, 2020, the Governor of California and the State Public Health Officer and Director of the California Department of Public Health ordered all
individuals living in the State of California to stay at their place of residence for an indefinite period of time (subject to certain exceptions to facilitate
authorized necessary activities) to mitigate the impact of the COVID-19 pandemic. Authorities in other states, where our customers, suppliers and partners
may be located, are following suit and issuing orders with similar goals and restrictions.
If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenues or achieve and sustain
profitability.
Our principal competition comes from commercial and academic organizations using established and new laboratory tests to produce
information that is similar to the information that we generate for our customers. These commercial and academic organizations may not utilize our
services or may not believe them to be superior to those tests that they currently use or others that are developed. Further, it may be difficult to convince our
customers to use our comprehensive test rather than simpler panels provided by our competitors. For example, the information that we provide may be
more challenging or require additional resources for our customers to interpret than the information provided by our competitors’ less comprehensive
assays.
Some of our present and potential competitors, including Guardant Health, Inc., Foundation Medicine, Inc., which was acquired by Roche
Holdings, Inc. in July 2018, Roche Molecular Systems, Inc., NanoString Technologies, Inc., Personal Genome Diagnostics, Inc., Adaptive Biotechnologies
Corporation, and NeoGenomics, Inc., may have widespread brand recognition and substantially greater financial and technical resources and development,
production capacities, and marketing capabilities than we do.
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They may be able to devote greater resources to the development, promotion, and sale of their products and services than we do or sell their products and
services at prices designed to win significant levels of market share. In addition, competitors may be acquired by, receive investments from, or enter into
other commercial relationships with larger, well-established, and well-financed companies. Others may develop lower-priced, less complex products and
services that pharmaceutical companies could view as functionally equivalent to our current or planned future services, which could force us to lower the
price of our services and impact our operating margins and our ability to achieve and maintain profitability. In addition, companies or governments that
control access to genetic testing and related services through umbrella contracts or regional preferences could promote our competitors or prevent us from
performing certain services. In addition, technological innovations that result in the creation of enhanced products or diagnostic tools that are more
sensitive or specific than ours may enable other clinical laboratories, hospitals, physicians, or medical providers to provide specialized products or services
similar to ours in a more patient-friendly, efficient, or cost-effective manner than is currently possible. If we cannot compete successfully against current or
future competitors, we may be unable to ensure or increase market acceptance and sales of our current or planned future services, which could prevent us
from increasing or sustaining our revenues or achieving or sustaining profitability.
We expect that biopharmaceutical companies will increasingly focus attention and resources on the targeted and personalized cancer diagnostic
sector as the potential and prevalence of molecularly targeted oncology therapies approved by the U.S. Food and Drug Administration (the “FDA”) along
with companion diagnostics increases. For example, the FDA has approved several such targeted oncology therapies that use companion diagnostics,
including the anaplastic lymphoma kinase FISH test from Abbott Laboratories, Inc. for use with Xalkori® from Pfizer Inc., the BRAF kinase V600
mutation test from Roche Molecular Systems, Inc. for use with Zelboraf® from Daiichi-Sankyo/Genentech/Roche, and the BRAF kinase V600 mutation
test from bioMerieux for use with Tafinlar® from GlaxoSmithKline. Since companion diagnostic tests are part of FDA labeling, non-FDA cleared tests,
such as the ones we currently offer as part of our services, would be considered an off-label use and this may limit our access to this market segment.
Additionally, projects related to cancer diagnostics and particularly genomics have received increased government funding, both in the United
States and internationally. As more information regarding cancer genomics becomes available to the public, we anticipate that more products aimed at
identifying targeted treatment options will be developed and that these products may compete with our services. In addition, competitors may develop their
own versions of our current or planned future services in countries where we did not apply for or receive patents and compete with us in those countries,
including encouraging the use of their products or services by biopharmaceutical companies in other countries.
We have substantial customer concentration, with a limited number of customers accounting for a substantial portion of our 2019 revenues
and accounts receivable.
Like other genomics profiling companies that sell to the pharmaceutical industry, we have customer concentration. We currently derive a
significant portion of our revenues from the U.S. Department of Veterans Affairs (the “VA”) Million Veteran Program (the “VA MVP”), which accounted
for 67% and 49% of our revenues for the year ended December 31, 2019 and 2018, respectively. Our top five customers, including the VA MVP, accounted
for 90% and 82% of our revenues for the year ended December 31, 2019 and 2018, respectively. There are inherent risks whenever a large percentage of
revenues are concentrated with a limited number of customers. It is not possible for us to predict the future level of demand for our services that will be
generated by these customers. In addition, revenues from our larger customers have historically fluctuated and may continue to fluctuate based on the
commencement and completion of clinical trials or other projects, the timing of which may be affected by market conditions or other facts, some of which
may be outside of our control. Further, while we have long-term contractual arrangements with certain of our customers, these customers are not required
to purchase a minimum number of analyses. If any of these customers suspend or terminate clinical trials, receive less funding, experience declining or
delayed sales, or otherwise chose to reduce or eliminate their use of our services, we could be pressured to reduce the prices we charge for our services
which would have an adverse effect on our margins and financial position, and which would likely negatively affect our revenues and results of operations.
In particular, if the VA MVP terminates our services for convenience, which it is permitted to do, such termination would have a material adverse effect on
our revenues, cash position, and results of operations. Further, if our largest customers were to cease using or stop payment for our services, it would have a
material adverse effect on our accounts receivable, increasing our credit risk. The failure of these customers to pay their balances, or any customer to pay
future outstanding balances, would result in an operating expense and reduce our cash flows.
We currently derive a substantial portion of our revenues from DNA sequencing and data analysis services that we provide to our largest
customer, the VA MVP. If the VA MVP’s demand for and/or funding for our DNA sequencing and data analysis services is substantially
reduced, our business, financial condition, operating results, and cash flows would be materially harmed.
We derive a substantial portion of our current and expected future revenues from sales of our DNA sequencing and data analysis services to the
VA MVP. In September 2017, we entered into a one-year contract with three one-year option renewal periods with the VA for the VA MVP, pursuant to
which we received orders from the VA MVP in September 2017, 2018, and 2019.
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The VA MVP’s orders for DNA sequencing and data analysis services are subject to the availability of funding, enrollment of veterans in the VA
MVP study, and the VA MVP’s continued demand for our services. We have no certainty that funding will be made available for our services. If the
priorities of the VA, the VA MVP, or the U.S. government change, funding for our services may be limited or not available, and our business, financial
condition, and operating results and cash flows would be materially harmed. The success of our business and our future operating results are significantly
dependent on the VA MVP’s receipt of funding for use of our services and the terms of our sales to the VA MVP, including the price per sample, the
number of samples and the timing of the VA MVP’s deliveries of samples.
If we cannot maintain our current customer relationships, or fail to acquire new customers, our revenue prospects will be reduced. Many of
our customers are biopharmaceutical companies engaged in clinical trials of new drug candidates, which trials are expensive, can take many
years to complete, and have inherently uncertain outcomes.
Our customers other than the VA MVP are primarily biopharmaceutical companies that use our services to support clinical trials. Our future
success is substantially dependent on our ability to maintain our customer relationships and to establish new ones. Many factors have the potential to
impact our customer relations, including the type of support our customers and potential customers require and our ability to deliver it, our customers’
satisfaction with our services, and other factors that may be beyond our control. Furthermore, our customers may decide to decrease or discontinue their use
of our services due to changes in research and product development plans, failures in their clinical trials, financial constraints, or utilization of internal
testing resources or tests performed by other parties, or other circumstances outside of our control.
We engage in conversations with customers regarding potential commercial opportunities on an ongoing basis in the event that one of these
customers’ drug candidates is approved. There is no assurance that any of these conversations will result in a commercial agreement, or if an agreement is
reached, that the resulting relationship will be successful or that clinical studies conducted as part of the engagement will produce successful outcomes.
Speculation in the industry about our existing or potential relationships with biopharmaceutical companies could be a catalyst for adverse speculation about
us, our services, and our technology, which can adversely affect our reputation and our business. In addition, the termination of these relationships could
result in a temporary or permanent loss of revenue.
Our customers’ clinical trials are expensive, can take many years to complete, and their outcome is inherently uncertain. Failure can occur at any
time during the clinical trial process. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having
progressed through pre-clinical studies and early clinical trials. Many of the biopharmaceutical companies that are our customers do not have products
approved for commercial sale and are not profitable. These customers must continue to raise capital in order to continue their development programs and to
potentially continue as our customers. If our customers’ clinical trials fail or they are unable to raise sufficient capital to continue investing in their clinical
programs, our revenues from these customers may decrease or cease entirely, and our business may be harmed. Furthermore, even if these customers have a
drug approved for commercial sale, they may not choose to use our services as a companion diagnostic with their drug, thereby limiting our potential
revenues.
Certain of our customers prepay us for a portion of the services that they expect to order from us in the future and we may be required to
refund some or all of those prepayments if a customer cancels its contract with us or reduces the level of services that it expects to receive.
Certain of our customers prepay us for a portion of the services that they expect to order from us before they place purchase orders and we
deliver those services. In some cases, this prepayment can be substantial and may be paid months or a year or more in advance of these customers
providing samples to us and before our delivery of the services to which some or all of the deposit relates. As of December 31, 2019, we had approximately
$36.0 million in customer deposits, including $32.5 million from one customer. However, as of that date, we had $128.3 million of cash and cash
equivalents, and short-term investments. We are generally not required by our contracts to retain these deposits in cash or otherwise and we have generally
used these deposits to make capital expenditures and fund our operations. If a customer that has prepaid us for future services cancels its contract with us or
reduces the level of services that it expects to receive, we would generally be required to repay that customer’s deposit with little or no notice. We may not
have the cash or other available resources to satisfy that repayment obligation. Even if we are able to satisfy the repayment obligation from available
resources, we may need to seek additional sources of capital to fund our operations, which funding may not be available when needed or on acceptable
terms. In either of those circumstances, our business, financial condition, results of operations, and reputation would be materially and adversely affected.
Furthermore, in the future, customers may elect not to prepay us for our services in which case we would have to find other sources of funding for our
capital expenditures and operations, which would be costly relative to the aforementioned cost-free customer deposit funding and which may not be
available when needed or on acceptable terms.
We rely on a limited number of suppliers, or in some cases, a sole supplier, for some of our laboratory instruments and materials, and we may
not be able to find replacements or immediately transition to alternative suppliers should we need to do so.
We rely on a limited number of suppliers for sequencers and other equipment and materials that we use in our laboratory operations. For
example, we rely on Illumina, Inc. (“Illumina”) as the sole supplier of sequencers and various associated reagents, and
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as the sole provider of maintenance and repair services for these sequencers. Our master subcontractor agreement with Illumina is set to expire in August
2021, and our various pricing agreements with Illumina are set to expire on various dates up to December 2022. Any disruption in Illumina’s operations, or
our inability to negotiate an extension to our agreements with Illumina on acceptable terms, or at all, could impact our supply chain and laboratory
operations and our ability to conduct our business and generate revenue. Our suppliers could cease supplying these materials, reagents, and equipment at
any time, or fail to provide us with sufficient quantities of materials or materials that meet our specifications. Our laboratory operations could be
interrupted if we encounter delays or difficulties in securing equipment, materials, reagents, or sequencers, or if we cannot obtain an acceptable substitute.
Any such interruption could significantly affect our business, financial condition, results of operations, and reputation.
We believe that there are only a few manufacturers other than Illumina that are currently capable of supplying and servicing the equipment
necessary for our laboratory operations, including sequencers and various associated reagents. The use of equipment or materials provided by these
replacement suppliers would require us to alter our laboratory operations. Transitioning to a new supplier would be time-consuming and expensive, would
likely result in interruptions in our laboratory operations, could affect the performance specifications of our laboratory operations, or could require that we
revalidate our tests. We cannot assure you that, if we were forced to replace Illumina or another supplier on which we rely, we would be able to secure
alternative equipment, reagents, and other materials, and bring such equipment, reagents, and materials on line and revalidate them without experiencing
interruptions in our workflow. If we encounter delays or difficulties in securing, reconfiguring, or revalidating the equipment and reagents we require for
our services, our business, financial condition, results of operations, and reputation could be adversely affected.
In addition, the Device Master File that we have filed with the FDA, which is focused on the technology, quality management, and validation of
our platform, specifically on its use for the development of personalized immunotherapies, is predicated on our use of specified equipment and processes,
including Illumina sequencers and related equipment. The detailed information in the Device Master File is not shared with our customers, but with our
permission they can reference our FDA file number in their Investigational New Drug filings with the FDA. If we were required to transition to a new
supplier of sequencers or certain other equipment or processes in our laboratory, our Device Master File would need to be replaced or updated, and until
such time as that occurred, customers for which we deliver services after the transition would not be able to reference our Device Master File, which would
cause us to lose a competitive advantage.
Our inability to raise additional capital on acceptable terms in the future may limit our ability to continue to operate our business and further
expand our operations.
We expect capital expenditures and operating expenses to increase over the next several years as we continue to operate our business and expand
our infrastructure, commercial operations, and research and development activities. Additionally, if we decide to grow our business by developing in vitro
diagnostic tests, our capital expenditures and operating expenses would significantly increase. We may seek to raise additional capital through equity
offerings, debt financings, collaborations, or licensing arrangements. Additional funding may not be available to us on acceptable terms, or at all.
The various ways we could raise additional capital carry potential risks. If we raise funds by issuing equity securities, dilution to our stockholders
would result. Any equity securities issued may also provide for rights, preferences, or privileges senior to those of holders of our common stock. In
addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our common stock to decline.
If we raise funds by issuing debt securities, those debt securities would have rights, preferences, and privileges senior to those of holders of our common
stock. The terms of debt securities issued or borrowings pursuant to a credit agreement, if available, could impose significant restrictions on our operations.
The incurrence of additional indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations and could also
result in restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire or
license intellectual property rights, and other operating restrictions that could adversely affect our ability to conduct our business. In the event that we enter
into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms. These agreements may require that we
relinquish or license to a third party on unfavorable terms our rights to tests we otherwise would seek to develop or commercialize ourselves, or reserve
certain opportunities for future potential arrangements when we might be able to achieve more favorable terms.
If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research and
development programs or sales and marketing initiatives. Our ability to raise additional capital may be adversely impacted by potential worsening global
economic conditions and the recent disruption to and volatility in the credit and financial markets in the United States and worldwide resulting from the
ongoing COVID-19 outbreak. In addition, we may have to work with a partner on one or more aspects of our tests or market development programs, which
could lower the economic value of those tests or programs to us. While we believe our existing cash and cash equivalents will be sufficient to meet our
anticipated cash requirements for at least the next 12 months, we cannot assure you that we will generate sufficient revenues from commercial sales to
adequately fund our operating needs or achieve or sustain profitability.
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We will need to invest in our infrastructure in advance of increased demand for our services, and our failure to accurately forecast demand
would have a negative impact on our business and our ability to achieve and sustain profitability.
In order to execute our business model, we need to invest in scaling our infrastructure, including hiring additional personnel, expanding our
internal quality assurance program, and expanding laboratory capacity. We will also need to purchase additional equipment, some of which can take several
months or more to procure, setup, and validate, and increase our software and computing capacity to meet increased demand. There is no assurance that any
of these increases in scale, expansion of personnel, equipment, software, and computing capacities, or process enhancements will be successfully
implemented, or that we will have adequate space in our laboratory facility to accommodate such required expansion. We expect that much of this growth
will be in advance of increased demand for our services. Our current and projected future expense levels are to a large extent fixed and are largely based on
our current investment plans and our estimates of future test volume. As a result, if revenues do not meet our expectations we may not be able to promptly
adjust or reduce our spending to levels commensurate with our revenues. If we fail to generate demand commensurate with our infrastructure growth or if
we fail to scale our infrastructure sufficiently in advance of demand to successfully meet such demand, our business, prospects, financial condition, and
results of operations could be adversely affected.
As we commercialize additional services or products, we may need to incorporate new equipment, implement new technology systems and
laboratory processes, or hire new personnel with different qualifications. Failure to manage this growth or transition could result in turnaround time delays,
higher costs, declining service and/or product quality, deteriorating customer service, and slower responses to competitive challenges. A failure in any one
of these areas could make it difficult for us to meet market expectations for our services, and could damage our reputation and the prospects for our
business.
If our sole laboratory facility becomes damaged or inoperable, or we are required to vacate the facility, our ability to sell and provide our
services and pursue our research and development efforts may be jeopardized.
We currently derive our revenues from our genomic analysis conducted in our laboratory. We do not have any clinical reference laboratory
facilities other than our facility in Menlo Park, California. Our facilities and equipment could be harmed or rendered inoperable by natural or man-made
disasters, including fires, earthquakes, flooding, and power outages, which may render it difficult or impossible for us to sell or perform our services for
some period of time. Additionally, as a result of the ongoing COVID-19 outbreak, we may limit our operations or temporarily close our office and/or
laboratory space. Northern California has recently experienced serious fires and the San Francisco Bay Area is considered to lie in an area with earthquake
risk. The inability to sell or to perform our diagnostic and other services, disruptions in our operations, or the backlog of samples that could develop if our
facility is inoperable for even a short period of time, may result in the loss of customers or harm to our reputation or relationships with scientific or clinical
collaborators, and we may be unable to regain those customers or repair our reputation or such relationships in the future. Furthermore, our facilities and
the equipment we use to perform our services and our research and development work could be costly and time-consuming to repair or replace.
Additionally, a key component of our research and development process involves using biological samples as the basis for the development of
our services. In some cases, these samples are difficult to obtain. If the parts of our laboratory facility where we store these biological samples were
damaged or compromised, our ability to pursue our research and development projects, as well as our reputation, could be jeopardized. We carry insurance
for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses and may not
continue to be available to us on acceptable terms, if at all.
Further, if our laboratory became inoperable, we would likely not be able to license or transfer our technology to another facility with the
qualifications, including state licensure and CLIA certification, that would be necessary to cover the scope of our current and our planned future services.
Even if we were to find a facility with such qualifications to perform our services, it may not be available to us on commercially reasonable terms.
Our internal information technology systems, or those of our third-party vendors, contractors, or consultants, may fail or suffer security
breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our services, compromise sensitive
information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise
adversely affecting our business.
We are increasingly dependent upon information technology systems, infrastructure, and data to operate our business. In the ordinary course of
business, we collect, store, and transmit confidential information (including but not limited to intellectual property, proprietary business information, and
personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We also
have outsourced elements of our operations to third parties, and as a result we manage a number of third-party vendors and other contractors and
consultants who have access to our confidential information.
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Despite the implementation of security measures, given the size and complexity of our internal information technology systems and those of our
third-party vendors and other contractors and consultants, and the increasing amounts of confidential information that they maintain, our such information
technology systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural
disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our
employees, third-party vendors, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties
(including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering, and other means to affect service reliability and
threaten the confidentiality, integrity, and availability of information), which may compromise our system infrastructure, or that of our third-party vendors
and other contractors and consultants, or lead to data leakage. The risk of a security breach or disruption, particularly through cyber-attacks or cyber
intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity, and sophistication of
attempted attacks and intrusions from around the world have increased. We may not be able to anticipate all types of security threats, and we may not be
able to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently, may not be
recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime
affiliates, terrorist organizations, or hostile foreign governments or agencies. To the extent that any disruption or security breach were to result in a loss of,
or damage to, our data or applications, or those of our third-party vendors and other contractors and consultants, or inappropriate disclosure of confidential
or proprietary information, we could incur liability and reputational damage and the further development and commercialization of our services could be
delayed. The costs related to significant security breaches or disruptions could be material and exceed the limits of the cybersecurity insurance we maintain
against such risks. If the information technology systems of our third-party vendors and other contractors and consultants become subject to disruptions or
security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of
such an event, and to develop and implement protections to prevent future events of this nature from occurring.
While we have not experienced any such system failure, accident, or security breach to date and believe that our data protection efforts and our
investment in information technology reduce the likelihood of such incidents in the future, we cannot assure you that our data protection efforts and our
investment in information technology will prevent significant breakdowns, data leakages, breaches in our systems, or those of our third-party vendors and
other contractors and consultants, or other cyber incidents that could have a material adverse effect upon our reputation, business, operations, or financial
condition. For example, if such an event were to occur and cause interruptions in our operations, or those of our third-party vendors and other contractors
and consultants, it could result in a material disruption of our programs and the development of our services and technologies could be delayed.
Furthermore, significant disruptions of our internal information technology systems or those of our third-party vendors and other contractors and
consultants, or security breaches could result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to,
confidential information (including trade secrets or other intellectual property, proprietary business information, and personal information), which could
result in financial, legal, business, and reputational harm to us. For example, any such event that leads to unauthorized access, use, or disclosure of personal
information, including personal information regarding our customers or employees, could harm our reputation directly, compel us to comply with federal
and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, and otherwise subject us to liability under laws
and regulations that protect the privacy and security of personal information, which could result in significant legal and financial exposure and reputational
damages that could potentially have an adverse effect on our business.
Security breaches, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from
accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
In the ordinary course of our business, we collect and store sensitive data, including protected health information (“PHI”), personally identifiable
information (“PII”), credit card and other financial information, intellectual property, and proprietary business information owned or controlled by
ourselves or our customers, payors, and other parties. We manage and maintain our applications and data utilizing a combination of on-site systems and
cloud-based data centers. We utilize external security and infrastructure vendors to manage parts of our data centers. We also communicate sensitive data,
including patient data, electronically, and through relationships with multiple third-party vendors and their subcontractors. These applications and data
encompass a wide variety of business-critical information, including research and development information, patient data, commercial information, and
business and financial information. We face a number of risks relative to protecting this critical information, including loss of access risk, inappropriate use
or disclosure, inappropriate modification, and the risk of our being unable to adequately monitor, audit, and modify our controls over our critical
information. This risk extends to the third-party vendors and subcontractors we use to manage this sensitive data.
The secure processing, storage, maintenance, and transmission of this critical information are vital to our operations and business strategy, and
we devote significant resources to protecting such information. Although we take measures to protect sensitive data from unauthorized access, use or
disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee error,
malfeasance, or other malicious or inadvertent disruptions. Any such breach or interruption could compromise our networks and the information stored
there could be accessed by unauthorized parties, manipulated, publicly disclosed, lost, or stolen. Any such access, breach, or other loss of information could
result in legal claims or proceedings, liability under federal or state laws that protect the privacy of personal information, such as the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and
regulatory penalties. Notice of breaches must be made to affected individuals, the Secretary of the Department of Health and Human Services (“HHS”),
and for extensive breaches, notice may need to be made to the media or state attorneys general. Such a
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notice could harm our reputation and our ability to compete. Although we have implemented security measures and a formal, dedicated enterprise security
program to prevent unauthorized access to patient data, such data is currently accessible through multiple channels, and there is no guarantee we can
protect our data from breach. Unauthorized access, loss, or dissemination could also damage our reputation or disrupt our operations, including our ability
to conduct our analyses, deliver test results, process claims and appeals, provide customer assistance, conduct research and development activities, collect,
process, and prepare company financial information, provide information about our tests and other patient and physician education and outreach efforts
through our website, and manage the administrative aspects of our business. Additionally, in connection with the ongoing COVID-19 pandemic, most of
our employees are working remotely, which may increase the risk of security breaches, loss of data, and other disruptions as a consequence of more
employees accessing sensitive and critical information from remote locations.
Penalties for violations of these laws vary. For instance, penalties for failure to comply with a requirement of HIPAA and HITECH vary
significantly, and include significant civil monetary penalties and, in certain circumstances, criminal penalties with fines up to $250,000 per violation
and/or imprisonment. In addition, numerous breach incidents could lead to possible penalties in excess of $1.68 million. A person who knowingly obtains
or discloses individually identifiable health information in violation of HIPAA may face a criminal penalty of up to $50,000 and up to one-year
imprisonment. The criminal penalties increase if the wrongful conduct involves false pretenses or the intent to sell, transfer or use identifiable health
information for commercial advantage, personal gain or malicious harm.
Further, various states, such as California and Massachusetts, have implemented similar privacy laws and regulations, such as the California
Confidentiality of Medical Information Act, that impose restrictive requirements regulating the use and disclosure of health information and other
personally identifiable information. These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to
individuals than HIPAA. Where state laws are more protective, we have to comply with the stricter provisions. In addition to fines and penalties imposed
upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused.
California’s patient privacy laws, for example, provide for penalties of up to $250,000 and permit injured parties to sue for damages. The interplay of
federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and data we
receive, use and share, potentially exposing us to additional expense, adverse publicity and liability. Further, as regulatory focus on privacy issues continues
to increase and laws and regulations concerning the protection of personal information expand and become more complex, these potential risks to our
business could intensify. Changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as PHI or PII, for
the treatment of genetic data, along with increased customer demands for enhanced data security infrastructure, could greatly increase our cost of providing
our services, decrease demand for our services, reduce our revenues and/or subject us to additional liabilities.
In addition, the interpretation and application of consumer, health-related and data protection laws, especially with respect to genetic samples and
data, in the United States, the European Union (the “EU”), and elsewhere are often uncertain, contradictory and in flux. For example, the EU-wide General
Data Protection Regulation (EU) 2016/679 (“GDPR”) became applicable on May 25, 2018, replacing data protection laws issued by of each EU member
state based on the Directive 95/46/EC (the “Directive”). Unlike the Directive, which needed to be transposed at a national level, the GDPR text is directly
applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU. The GDPR imposes onerous
accountability obligations requiring data controllers and processors to maintain a record of their data processing and policies. It requires data controllers to
implement more stringent operational requirements for processors and controllers of personal data, including, for example, transparent and expanded
disclosure to data subjects (in a concise, intelligible and easily accessible form) about how their personal information is to be used, imposes limitations on
retention of information, increases requirements pertaining to health data and pseudonymized (i.e., key-coded) data, introduces mandatory data breach
notification requirements, and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing
activities. Fines for non-compliance with the GDPR will be significant—the greater of €20 million or 4% of global turnover. The GDPR provides that EU
member states may introduce further conditions, including limitations, to make their own further laws and regulations limiting the processing of genetic,
biometric, or health data, which could limit our ability to collect, use and share European data, or could cause our compliance costs to increase, ultimately
having an adverse impact on our business, and harm our business and financial condition. It is possible that these laws may be interpreted and applied in a
manner that is inconsistent with our practices. If so, this could result in government-imposed fines or orders requiring that we change our practices, which
could adversely affect our business. Further, the United Kingdom’s vote in favor of exiting the EU, often referred to as Brexit, and ongoing developments
in the United Kingdom regarding Brexit have created uncertainty with regard to data protection regulation in the United Kingdom. In particular, it is
unclear whether the United Kingdom will enact data protection legislation equivalent to the GDPR and how data transfers to and from the United Kingdom
will be regulated.
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Compliance with U.S. and international data protection laws and regulations could cause us to incur substantial costs or require us to change our
business practices and compliance procedures in a manner adverse to our business. Moreover, complying with these various laws could require us to take
on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain
jurisdictions. We rely on our customers to obtain valid and appropriate consents from data subjects whose genetic samples and data we process on such
customers’ behalf. Given that we do not obtain direct consent from such data subjects and we do not audit our customers to ensure that they have obtained
the necessary consents required by law, the failure of our customers to obtain consents that are in compliance with applicable law could result in our own
non-compliance with privacy laws. Such failure to comply with U.S. and international data protection laws and regulations could result in government
enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating
results and business. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual
obligations, even if we are not found liable, could be expensive and time consuming to defend, could result in adverse publicity and could have a material
adverse effect on our business, financial condition and results of operations.
Our success depends on our ability to provide reliable, high-quality genomic data and analyses and to rapidly evolve to meet our customers’
needs.
Errors, including if our tests fail to accurately detect gene variants, or mistakes, including if we fail to or incompletely or incorrectly identify the
significance of gene variants, could have a significant adverse impact on our business. We classify variants in accordance with guidelines that are subject to
change and subject to our interpretation. There can also be flaws in the databases, third-party tools, and algorithms we use, and in the software that handles
automated parts of our classification protocol. If we receive poor quality or degraded samples, our tests may be unable to accurately detect gene variants or
we may fail to or incompletely or incorrectly identify the significance of gene variants, which could have a significant adverse impact on our business.
Inaccurate results or misunderstandings of, or inappropriate reliance on, the information we provide to our customers could lead to, or be
associated with, side effects or adverse events in patients who use our tests, including treatment-related death, and could lead to termination of our services
or claims against us. A product liability or professional liability claim could result in substantial damages and be costly and time-consuming for us to
defend.
Although we maintain liability insurance, including for errors and omissions and professional liability, we cannot assure you that our insurance
would be sufficient to protect us from the financial impact of defending against these types of claims, or any judgments, fines, or settlement costs arising
out of any such claims. Any liability claim, including an errors and omissions liability claim, brought against us, with or without merit, could increase our
insurance rates or prevent us from securing insurance coverage in the future. Additionally, any liability lawsuit could cause injury to our reputation or cause
us to suspend sales of our tests or cause a suspension of our license to operate. The occurrence of any of these events could have an adverse effect on our
business, reputation, and results of operations.
If we cannot develop services and products to keep pace with rapid advances in technology, medicine, and science, or if we experience delays
in developing such services and products, our operating results and competitive position could be harmed.
In recent years, there have been numerous advances in technologies relating to the diagnosis and treatment of cancer. Several new cancer drugs
have been approved, and a number of new drugs are in pre-clinical and clinical development. There have also been advances in methods used to identify
patients likely to benefit from these drugs based on analysis of biomarkers. We must continuously develop new services and products, enhance any existing
services, and avoid delays in such developments and enhancements to keep pace with evolving technologies on a timely and cost-effective basis. Our
current services and our planned future services and products (such as our planned liquid biopsy test) could become obsolete unless we continually
innovate and expand them to demonstrate benefit in the diagnosis, monitoring, or prognosis of patients with cancer. New cancer therapies typically have
only a few years of clinical data associated with them, and much of that data may not be disclosed by the pharmaceutical company that conducted the
clinical trials. This could limit our ability to develop services and products based on, for example, biomarker analysis related to the appearance or
development of resistance to those therapies. If we cannot adequately demonstrate the clinical utility of our services and our planned future services and
products to new treatments, sales of our services could decline, which would have a material adverse effect on our business, financial condition, and results
of operations.
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We are researching and developing improvements to our tests and test features on a continuous basis, but we may not be able to make these
improvements on a timely basis, and even if we do, we may not realize the benefits of these efforts in our financial results.
To remain competitive, we must continually research and develop improvements to our tests or test features. However, we cannot assure you that
we will be able to develop and commercialize the improvements to our tests or test features on a timely basis. Our competitors may develop and
commercialize competing or alternative tests and improvements faster than we are able to do so. In addition, we must expend significant time and funds in
order to conduct research and development, further develop and scale our laboratory processes, and further develop and scale our infrastructure. We may
never realize a return on investment on this effort and expense, especially if our improvements fail to perform as expected. If we are not able to realize the
benefits of our efforts to improve our tests or test features, it could have an adverse effect on our business, financial condition, and results of operations.
Personalized cancer therapies represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical
development, or delays in or inability to achieve regulatory approval, commercialization, or payor coverage, any of which could adversely
affect our business.
We currently work with certain companies developing personalized cancer therapies, and our future success will in part depend on our
personalized cancer customers obtaining regulatory approval for and commercializing their product candidates. Because personalized cancer therapies
represent a new approach to immunotherapy for the treatment of cancer and other diseases, developing and commercializing personalized cancer therapies
is subject to a number of challenges.
Actual or perceived safety issues, including adoption of new therapeutics or novel approaches to treatment, may adversely influence the
willingness of subjects to participate in clinical studies, or if approved by applicable regulatory authorities, of physicians to subscribe to the novel treatment
mechanics. The FDA or other applicable regulatory authorities may ask for specific post-market requirements, and additional information regarding
benefits or risks of our services may emerge at any time prior to or after regulatory approval.
Physicians, hospitals, and third-party payors often are slow to adopt new products, technologies, and treatment practices that require additional
upfront costs and training. Physicians may not be willing to undergo training to adopt personalized cancer therapies, may decide that such therapies are too
complex to adopt without appropriate training or not cost-efficient, and may choose not to administer these therapies. Based on these and other factors,
hospitals and payors may decide that the benefits of personalized cancer therapies do not or will not outweigh their costs.
The loss of key members of our executive management team could adversely affect our business.
Our success in implementing our business strategy depends largely on the skills, experience, and performance of key members of our executive
management team and others in key management positions, including John West, our Chief Executive Officer, Richard Chen, our Chief Scientific Officer,
Clinton Musil, our Chief Business Officer, and Aaron Tachibana, our Chief Financial Officer. The collective efforts of each of these persons and others
working with them as a team are critical to us as we continue to develop our technologies, services, products, and research and development programs. As a
result of the difficulty in locating qualified new management, the loss or incapacity of existing members of our executive management team could
adversely affect our operations. If we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors,
competing effectively, developing our technologies, and implementing our business strategy. Each member of our executive management team has an
employment agreement; however, the existence of an employment agreement does not guarantee retention of members of our executive management team,
and we may not be able to retain those individuals. We do not maintain “key person” life insurance on any of our employees.
In addition, we rely on collaborators, consultants, and advisors, including scientific and clinical advisors, to assist us in formulating our research
and development and commercialization strategy. Our collaborators, consultants, and advisors are generally employed by employers other than us and may
have commitments under agreements with other entities that may limit their availability to us.
The loss of a key employee, the failure of a key employee to perform in his or her current position, or our inability to attract and retain skilled
employees could result in our inability to continue to grow our business or to implement our business strategy.
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We rely on highly skilled personnel in a broad array of disciplines and if we are unable to hire, retain, or motivate these individuals, or
maintain our corporate culture, we may not be able to maintain the quality of our services or grow effectively.
Our performance, including our research and development programs and laboratory operations, largely depends on our continuing ability to
identify, hire, develop, motivate, and retain highly skilled personnel for all areas of our organization. Competition in our industry for qualified employees is
intense, and we may not be able to attract or retain qualified personnel in the future, including bioinformatic scientists, bioinformatic engineers, software
engineers, statisticians, variant curators, clinical laboratory scientists, and genetic counselors, due to the competition for qualified personnel among life
science businesses, technology companies, as well as universities and public and private research institutions, particularly in the San Francisco Bay Area.
All of our U.S. employees are at-will, which means that either we or the employee may terminate their employment at any time. In addition, our
compensation arrangements, such as our equity award programs, may not always be successful in attracting new employees and retaining and motivating
our existing employees for reasons that may include movements in our stock price. If we are not able to attract and retain the necessary personnel to
accomplish our business objectives, we may experience constraints that could adversely affect our ability to scale our business and support our research and
development efforts and our laboratory operations. We believe that our corporate culture fosters innovation, creativity, and teamwork. However, as our
organization grows, we may find it increasingly difficult to maintain the beneficial aspects of our corporate culture. This could negatively impact our ability
to retain and attract employees and our future success.
We may not be able to manage our future growth effectively, which could make it difficult to execute our business strategy.
Our expected future growth could create a strain on our organizational, administrative, and operational infrastructure, including laboratory
operations, quality control, customer service, marketing and sales, and management. We may not be able to maintain the quality of or expected turnaround
times for our tests, or satisfy customer demand as our test volume grows. Our ability to manage our growth properly will require us to continue to improve
our operational, financial, and management controls, as well as our reporting systems and procedures. As a result of our growth, our operating costs may
escalate even faster than planned, and some of our internal systems may need to be enhanced or replaced. If we are unable to manage our growth
effectively, it may be difficult for us to execute our business strategy and our business could be harmed.
We depend on our information technology systems, and any failure of these systems could harm our business.
We depend on information technology and telecommunications systems for significant elements of our operations, including our laboratory
information management system, our bioinformatics analytical software systems, our database of information relating to genetic variations and their role in
disease process, our clinical report systems, our billing systems, our business intelligence systems, our logistics and customer relationship systems, our
customer-facing web-based software, our customer reporting, and our family history and risk assessment tools. We have installed, and expect to expand, a
number of enterprise software systems that affect a broad range of business processes and functional areas, including, for example, systems handling
human resources, financial reporting and controls, customer relationship management, regulatory compliance, and other infrastructure operations.
Although we invest substantially in the backup/restore, high-availability architecture, monitoring and reporting, documentation and preventive
security controls of our systems, all information technology and telecommunications systems are vulnerable to damage from a variety of sources, including
telecommunications or network failures, malicious or inadvertent human acts and natural disasters. Our servers are potentially vulnerable to physical or
electronic break-ins, employee errors, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent
unanticipated problems that could affect our information technology and telecommunications systems, failures or significant downtime of our information
technology or telecommunications systems or those used by our third-party service providers could prevent us from conducting tests, preparing and
providing reports to our customers, billing customers, collecting revenue, handling inquiries from our customers, conducting research and development
activities, and managing the administrative aspects of our business. For example, in the first quarter of 2018, we experienced downtime in our information
technology systems in connection with the adoption of certain new information technology, and our results of operations in the first and second quarters of
2018 were adversely affected as a result. Any disruption or loss of information technology or telecommunications systems on which critical aspects of our
operations depend could have an adverse effect on our business.
Additionally, we have internally developed, and expect to continue to invest in and expand, proprietary informatics and software systems that are
designed to manage the unique aspects and challenges of our genomics laboratory and on which we depend. Any disruption of failure of our internally
developed informatics and software systems could have an adverse effect on our business.
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Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and
requirements, which could cause significant liability for us and harm our reputation.
We are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with government regulations,
including federal and state healthcare fraud and abuse laws and regulations, to misuse information, including patient information, and to report financial
information or data accurately or disclose unauthorized activities to us. Such misconduct could also involve the improper use of information obtained in the
course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have a code of conduct and ethics for our
directors, officers and employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent
this activity may not be effective in controlling risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming
from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending
ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of
significant administrative, civil and criminal penalties, damages, fines, imprisonment, exclusion from government healthcare programs, contractual
damages, refunding of payments received by us, reputational harm, additional reporting, or oversight obligations if we become subject to a corporate
integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations. Whether or
not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of
management in defending ourselves against any of these claims or investigations.
We may acquire businesses or assets, form joint ventures, or make investments in other companies or technologies that could harm our
operating results, dilute our stockholders’ ownership, or cause us to incur debt or significant expense.
As part of our business strategy, we may pursue acquisitions of complementary businesses or assets, as well as technology licensing
arrangements. We may also pursue strategic alliances that leverage our core technology and industry experience to expand our offerings or distribution, or
make investments in other companies. As an organization, we have limited experience with respect to acquisitions as well as the formation of strategic
alliances and joint ventures. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not
realize the anticipated benefits of any acquisition, technology license, strategic alliance, joint venture or investment. In addition, we may not be able to find
suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. Any future acquisitions by us
also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could harm our operating results. If we make any
acquisitions in the future, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or
contingent liabilities. Integration of an acquired company or business also may require management resources that otherwise would be available for
ongoing development of our existing business.
To finance any acquisitions or investments, we may choose to raise additional funds. The various ways we could raise additional funds carry
potential risks. See “—Our inability to raise additional capital on acceptable terms in the future may limit our ability to continue to operate our business
and further expand our operations.” If the price of our common stock is low or volatile, we may not be able to acquire other companies using stock as
consideration. Alternatively, it may be necessary for us to raise additional funds for these activities through public or private financings. Additional funds
may not be available on terms that are favorable to us, or at all.
We rely on commercial courier delivery services to transport specimens to our laboratory facility in a timely and cost-efficient manner, and if
these delivery services are disrupted, our business would be harmed.
Our business depends on our ability to quickly and reliably provide test results to our customers, which in turn, requires that specimens are
transported and delivered to us in a timely manner. Disruptions in delivery service, whether due to labor disruptions, bad weather, natural disaster, terrorist
acts, or threats or for other reasons could adversely affect specimen integrity and our ability to process specimens in a timely manner and service our
customers, and ultimately our reputation and our business. In addition, if we are unable to continue to obtain expedited delivery services on commercially
reasonable terms, our operating results may be adversely affected.
Ethical, legal, and social concerns related to the use of genetic information could reduce demand for our tests.
Genetic testing has raised ethical, legal, and social concerns regarding privacy and the appropriate uses of the resulting information.
Governmental authorities have, through the Genetic Information Nondisclosure Act, and could further, for social or other purposes, limit or regulate the use
of genetic information or genetic testing or prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure.
Ethical and social concerns may also influence governmental authorities to deny or delay the issuance of patents for technology relevant to our business.
Similarly, these concerns may lead patients to refuse to use, or clinicians to be reluctant to order, genetic tests even if permissible. These and other ethical,
legal, and social concerns may limit market acceptance of our tests or reduce the potential markets for our tests, either of which could have an adverse
effect on our business, financial condition, or results of operations.
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The 2017 tax reform law and possible future changes in tax laws or regulations could adversely affect our business and financial condition.
On December 22, 2017, President Trump signed into law comprehensive tax legislation (the “Tax Cuts and Jobs Act”) that significantly revised
the Internal Revenue Code of 1986, as amended (the “Code”). Future guidance from the U.S. Internal Revenue Service and other tax authorities with
respect to the Tax Cuts and Jobs Act may affect us, and certain aspects of the Tax Cuts and Jobs Act could be repealed or modified in future legislation.
Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings, and the
deductibility of expenses under the Tax Cuts and Jobs Act or future tax reform legislation could have a material impact on the value of our deferred tax
assets, could result in significant one-time charges in the current or future taxable years, and could increase our future U.S. tax expense. The foregoing
items, as well as any other future changes in tax laws, could have a material adverse effect on our business, cash flow, financial condition, or results of
operations. In addition, it is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act or any newly enacted federal tax
legislation.
Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
We are subject to taxation in numerous U.S. states and territories. As a result, our effective tax rate is derived from a combination of applicable
tax rates in the various places that we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of
such places. Nevertheless, our effective tax rate may be different than experienced in the past due to numerous factors, including passage of the Tax Cuts
and Jobs Act, changes in the mix of our profitability from state to state, the results of examinations and audits of our tax filings, our inability to secure or
sustain acceptable agreements with tax authorities, changes in accounting for income taxes and changes in tax laws. Any of these factors could cause us to
experience an effective tax rate significantly different from previous periods or our current expectations and may result in tax obligations in excess of
amounts accrued in our financial statements.
Risks Related to Government Regulation
Our tests may be subject to regulatory action if regulatory agencies determine that our tests do not appropriately comply with statutory and
regulatory requirements enforced by the U.S. Food and Drug Administration, and/or CLIA requirements for quality laboratory testing.
The laws and regulations governing the marketing of clinical laboratory tests are extremely complex and in many instances there are no
significant regulatory or judicial interpretations of these laws and regulations. The Federal Food, Drug and Cosmetic Act (the “FDC Act”) defines a
medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including
a component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of
disease, in man or other animals. Some of our tests may be considered by the FDA to be in vitro diagnostic products that are subject to regulation as
medical devices. Among other things, pursuant to the FDC Act and its implementing regulations, the FDA regulates the research, testing, manufacturing,
safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the
United States to ensure that medical products distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the
import and export of medical devices.
Although the FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, the FDA has generally
exercised its enforcement discretion and not enforced applicable regulations with respect to laboratory developed tests (“LDTs”), which are a subset of in
vitro diagnostic devices that are intended for clinical use and designed, manufactured, and used entirely within a single laboratory. We currently market our
tests as LDTs and, therefore, we believe that they are not currently subject to the FDA’s enforcement of its medical device regulations and the applicable
FDC Act provisions. Despite the FDA’s historic enforcement discretion policy with respect to LDTs, in November 2017, the FDA finalized a classification
order setting out the regulatory requirements that apply to certain genetic health risk tests and revised a separate classification order exempting certain
carrier screening tests from FDA premarket clearance and approval requirements when certain regulatory requirements are met. None of our tests comply
with these classification orders because we market our tests as LDTs that are subject to the FDA’s policy of enforcement discretion. However, the FDA may
find that our tests do not fall within the definition of an LDT, and may determine that our tests are subject to the FDA’s enforcement of its medical device
regulations, including the recent classification orders, and the applicable FDC Act provisions. While we believe that we are currently in material
compliance with applicable laws and regulations, we cannot assure you that the FDA or other regulatory agencies would agree with our determination, and
a determination that we have violated these laws, or a public announcement that we are being investigated for possible violations of these laws, could
adversely affect our business, prospects, results of operations or financial condition. If the FDA determines that our tests are subject to enforcement as
medical devices, we could be subject to enforcement action, including administrative and judicial sanctions, and additional regulatory controls and
submissions for our tests, all of which could be burdensome. See “—Failure to comply with federal, state, and foreign laboratory licensing requirements
and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions
to our business or become subject to administrative or judicial sanctions.”
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Moreover, LDTs may in the future become subject to more onerous regulation by the FDA. A significant change in any of the laws, regulations,
or policies may require us to change our business model in order to maintain regulatory compliance. At various times since 2006, the FDA has issued
documents outlining its intent to require varying levels of FDA oversight of many types of LDTs. In October 2014, the FDA issued two non-binding draft
guidance documents that set forth a proposed risk-based regulatory framework that would apply varying levels of FDA oversight to LDTs. The FDA
indicated that it did not intend to implement its proposed framework until the draft guidance documents are finalized. The FDA was expected to finalize its
proposal for the oversight of LDTs before the end of 2016, but in November 2016, the FDA announced that it would halt finalizing of the guidance
documents and continue to work with stakeholders, the incoming administration, and Congress on the approach to LDT regulation. This announcement was
followed by the issuance of an information discussion paper on January 13, 2017, in which the FDA outlined a substantially revised “possible approach” to
the oversight of LDTs. The discussion paper explicitly states that it is not a final version of the 2014 draft guidance and that it is not enforceable and does
not represent the FDA’s “formal position.” It is unclear at this time if or when the FDA will finalize its plans to end enforcement discretion for LDTs, and
even then, whether the new regulatory requirements are expected to be phased-in over time. However, the FDA may decide to regulate certain LDTs on a
case-by-case basis at any time, which could result in delay or additional expense in offering our tests and tests that we may develop in the future.
Legislative proposals addressing oversight of genetic testing and LDTs have been introduced in previous Congresses, and we expect that new
legislative proposals will be introduced from time to time in the future. We cannot provide any assurance that FDA regulation, including pre-market review,
will not be required in the future for our tests, whether through finalization of guidance issued by the FDA, new enforcement policies adopted by the FDA
or new legislation enacted by Congress. It is possible that legislation will be enacted into law or guidance could be issued by the FDA that may result in
increased regulatory burdens for us to continue to offer our tests or to develop and introduce new tests. This legislative and regulatory uncertainty exposes
us to the possibility of enforcement action or additional regulatory controls and submissions for our tests, both of which could be burdensome. We cannot
be certain that the FDA will not enact rules or guidance documents that could impact our ability to purchase certain materials necessary for the performance
of our tests, such as products labeled for research use only. Should any of the reagents obtained by us from suppliers and used in conducting our tests be
affected by future regulatory actions, our business could be adversely affected by those actions, including increasing the cost of testing or delaying,
limiting, or prohibiting the purchase of reagents necessary to perform testing.
Additionally, the Centers for Medicare & Medicaid Services (“CMS”), and certain state agencies regulate the performance of LDTs (as
authorized under CLIA and state law, respectively). Our tests are developed in compliance with CLIA requirements. However, if our laboratory fails to
comply with the prescribed quality requirements for laboratory testing or other requirements for CLIA, we could lose CLIA certification. That in turn
would impact our ability to operate our laboratory and provide results to our customers, which could negatively impact our business operations.
If the FDA determines that our services are subject to enforcement as medical devices, we could incur substantial costs and time delays
associated with satisfying statutory and regulatory requirements such as pre-market clearance or approval and we could incur additional
expense in offering our tests and tests that we may develop in the future.
If the FDA determines that our tests and associated software do not fall within the definition of an LDT, or there are regulatory or legislative
changes, we may be required to obtain premarket clearance for our tests and associated software under Section 510(k) of the FDC Act or approval of a
premarket approval application (“PMA”). We would also be subject to ongoing regulatory requirements such as registration and listing requirements,
medical device reporting requirements, and quality control requirements. If our tests are considered medical devices not subject to enforcement discretion,
the regulatory requirements to which our tests are subject would depend on the FDA’s classification of our tests. The FDA has issued regulations
classifying over 1,700 different generic types of medical devices into one of three regulatory control categories (Class I, Class II, or Class III) depending on
the degree of regulation that the FDA finds necessary to provide reasonable assurance of their safety and effectiveness. The class into which a device is
placed determines the requirements that a medical device manufacturer must meet both pre- and post-market.
Generally, Class I devices do not require premarket authorization, but are subject to a comprehensive set of regulatory authorities referred to as
general controls. Class II devices, in addition to general controls, generally require special controls and premarket clearance through the submission of a
section 510(k) premarket notification. Class III devices are subject to general controls and special controls, and also require premarket approval prior to
commercial distribution, which is a more rigorous process than premarket clearance. Under the FDC Act, a device that is first marketed after May 28, 1976
is by default a Class III device requiring premarket approval unless it is within a type of generic device class that has been classified as Class I or Class II.
Even if a device falls under an existing Class II, non-exempt, device classification, the product must also be shown to be “substantially equivalent” to a
legally marketed predicate device through submission of a section 510(k) premarket notification. If after reviewing a firm’s 510(k) premarket notification,
the FDA determines that a device is not substantially equivalent to a legally marketed predicate device, the new device is classified into Class III, requiring
premarket approval. It is possible for a manufacturer to obtain a Class I or Class II designation without an appropriate predicate by submitting a de novo
request for reclassification.
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The process for submitting a 510(k) premarket notification and receiving FDA clearance usually takes from three to 12 months, but it can take
significantly longer and clearance is never guaranteed. The process for submitting and obtaining FDA approval of a PMA is much more costly, lengthy, and
uncertain. It generally takes from one to three years or even longer and approval is not guaranteed. PMA approval typically requires extensive clinical data
and can be significantly longer, more expensive and more uncertain than the 510(k) clearance process. Despite the time, effort and expense expended, there
can be no assurance that a particular device ultimately will be cleared or approved by the FDA through either the 510(k) clearance process or the PMA
process on a timely basis, or at all.
If our tests are considered medical devices not subject to enforcement discretion, one classification regulation that could be relevant to one or
more of our tests is a recently finalized classification for genetic health risk (“GHR”) assessment tests. On April 6, 2017, in response to a de novo request
for reclassification submitted by another company, the FDA issued an order classifying genetic tests known as genetic health risk assessment systems
(“GHR tests”) as Class II devices subject to premarket notification and specified special controls requirements. On November 7, 2017, the FDA codified
this classification at 21 C.F.R. § 866.5950. If our tests are considered medical devices that are not subject to enforcement discretion and one or more of our
tests is considered to fall under the 21 C.F.R. § 866.5950 classification regulation for GHR tests, or under another Class II classification that is subject to a
premarket notification requirement, we would be required to obtain marketing clearance for such tests. Further, if considered to fall under the 21 C.F.R. §
866.5950 classification for GHR tests, our tests would be required to adhere to specified special controls, such as labeling and testing specifications and
information about the test to be posted on the manufacturer’s website. Although the FDA has also issued a proposal for a simplified path to market GHR
tests that would amend the classification regulation at 21 C.F.R. § 886.5950 such that manufacturers would only be subject to a one-time marketing review
to ensure that they meet the applicable FDA requirements prior to selling GHR tests in the market, the FDA has yet to finalize this proposal, and we do not
know if and when finalization will occur. Even if the FDA finalizes the proposed limited exemption for GHR tests, if any of our current or pipeline tests are
not considered by the FDA to be GHR tests or do not qualify for the limited exemption (if and when finalized), or if any of our tests fall under a different
non-exempt classification or are unclassified, we could be required to obtain 510(k) clearance or approval of a PMA for such test in the future.
If premarket review of our tests is required, the premarket review process may involve, among other things, successfully completing additional
clinical trials. If we are required to conduct premarket clinical trials, whether using prospectively acquired samples or archival samples, delays in the
commencement or completion of clinical testing could significantly increase our product development costs, delay commercialization of any future
products, and interrupt sales of our current products. Many of the factors that may cause or lead to a delay in the commencement or completion of clinical
trials may also ultimately lead to delay or denial of regulatory clearance or approval. The commencement of clinical trials may be delayed due to
insufficient patient enrollment, which is a function of many factors, including the size of the patient population, the concerns around genetic testing, the
nature of the protocol, the proximity of patients to clinical sites, and the eligibility criteria for the clinical trial.
If we are required to conduct clinical trials, we and any third-party contractors we engage would be required to comply with good clinical
practices (“GCPs”), which are regulations and guidelines enforced by the FDA, for products in clinical development. The FDA enforces these GCPs
through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any third-party contractor fails to comply with applicable
GCPs, the clinical data generated in clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before
clearing or approving our marketing applications. A failure to comply with these regulations may require us to repeat clinical trials, which would delay the
regulatory clearance or approval process. In addition, if these parties do not successfully carry out their contractual duties or obligations or meet expected
deadlines, or if the quality, completeness or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or
for other reasons, our clinical trials may have to be extended, delayed or terminated. Many of these factors would be beyond our control. We may not be
able to enter into replacement arrangements without undue delays or considerable expenditures. If there are delays in testing or approvals as a result of the
failure to perform by third parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval
for our tests. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes
would harm our ability to market our tests or to achieve or sustain profitability.
The FDA requires medical device manufacturers to comply with, among other things, current good manufacturing practices for medical devices,
set forth in the Quality System Regulation at 21 C.F.R. Part 820, which requires manufacturers to follow elaborate design, testing, control, documentation,
and other quality assurance procedures during the manufacturing process; the medical device reporting regulation, which requires that manufacturers report
to the FDA if their device or a similar device they market may have caused or contributed to a death or serious injury or malfunctioned in a way that would
likely cause or contribute to a death or serious injury if it were to recur; labeling regulations, including the FDA’s general prohibition against promoting
products for unapproved or “off-label” uses; the reports of corrections and removals regulation, which requires manufacturers to report to the FDA if a
device correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the FDC Act caused by the device
which may present a risk to health; and the establishment registration and device listing regulation.
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Moreover, there can be no assurance that any cleared or approved labeling claims will be consistent with our current claims or adequate to
support continued adoption of our products. If premarket review is required for some or all of our products, the FDA may require that we stop selling our
products pending clearance or approval, which would negatively impact our business. Even if our products are allowed to remain on the market prior to
clearance or approval, demand for our products may decline if there is uncertainty about our products, if we are required to label our products as
investigational by the FDA, or if the FDA limits the labeling claims we are permitted to make for our products. As a result, we could experience
significantly increased development costs and a delay in generating additional revenues from our services, or from other services or products now in
development.
In addition, any clearance or approval we obtain for our products may contain requirements for costly post-market testing and surveillance to
monitor the safety or efficacy of the product. The FDA has broad post-market enforcement powers, and if unanticipated problems with our products arise,
or if we or our suppliers fail to comply with regulatory requirements following FDA clearance or approval, we may become subject to enforcement actions
such as:
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restrictions on manufacturing processes;
restrictions on product marketing;
warning letters;
withdrawal or recall of products from the market;
refusal to approve pending PMAs, 510(k)s, or supplements to approved PMAs or cleared 510(k)s that we submit;
fines, restitution, or disgorgement of profits or revenue;
suspension or withdrawal of regulatory clearances or approvals;
limitation on, or refusal to permit, import or export of our products;
product seizures;
injunctions; or
imposition of civil or criminal penalties.
Moreover, the FDA strictly regulates the promotional claims that may be made about medical devices. In particular, a medical device may not be
promoted for uses that are not approved by the FDA as reflected in the device’s approved labeling. However, companies may share truthful and not
misleading information that is otherwise consistent with the product’s FDA approved labeling. The FDA and other agencies actively enforce the laws and
regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to
significant civil, criminal, and administrative penalties.
Failure to comply with federal, state, and foreign laboratory licensing requirements and the applicable requirements of the FDA or any other
regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to
administrative or judicial sanctions.
We are subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose
of providing information for the diagnosis, prevention, or treatment of disease. CLIA regulations establish specific standards with respect to personnel
qualifications, facility administration, proficiency testing, quality control, quality assurance, and inspections. We have a current CLIA certificate to conduct
our tests at our laboratory in Menlo Park, California. To renew this certificate, we are subject to survey and inspection every two years. Moreover, CLIA
inspectors may make random inspections of our clinical reference laboratory.
We are also required to maintain a license to conduct testing in California. California laws establish standards for day-to-day operation of our
clinical reference laboratory in Menlo Park, including the training and skills required of personnel and quality control. Several other states in which we
operate also require that we hold licenses to test specimens from patients in those states, under certain circumstances. For example, our clinical reference
laboratory is required to be licensed on a product-specific basis by New York as an out-of-state laboratory, and our products, as LDTs, must be approved by
the New York State Department of Health (the “NYDOH”) on a product-by-product basis before they are offered in New York. We are subject to periodic
inspection by the NYDOH and are required to demonstrate ongoing compliance with NYDOH regulations and standards. To the extent NYDOH identified
any non-compliance and we are unable to implement satisfactory corrective actions to remedy such non-compliance, the State of New York could withdraw
approval for our tests. Additionally, states such as Maryland, Pennsylvania, and Rhode Island may also require us to maintain out-of-state licenses. Other
states may have similar requirements or may adopt similar requirements in the future. Although
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we have obtained licenses from states where we believe we are required to be licensed, we may become aware of other states that require out-of-state
laboratories to obtain licensure in order to accept specimens from the state, and it is possible that other states currently have such requirements or will have
such requirements in the future. We may also be subject to regulation in foreign jurisdictions as we seek to expand international utilization of our tests or
such jurisdictions adopt new licensure requirements, which may require review of our tests in order to offer them or may have other limitations such as
restrictions on the transport of human blood necessary for us to perform our tests that may limit our ability to make our tests available outside of the United
States. Complying with licensure requirements in new jurisdictions may be expensive and/or time-consuming, may subject us to significant and
unanticipated delays, or may be in conflict with other applicable requirements.
Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions, including license
suspension, limitation, or revocation, directed plan of action, onsite monitoring, civil monetary penalties, and criminal sanctions as well as significant
adverse publicity. Any sanction imposed under CLIA, its implementing regulations or state or foreign laws or regulations governing clinical laboratory
licensure, or our failure to renew our CLIA certificate, a state or foreign license or accreditation, could have a material adverse effect on our business,
financial condition and results of operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and
potentially lose revenues in doing so.
Although we market our tests as LDTs that are currently subject to the FDA’s exercise of enforcement discretion, if we fail to operate within the
conditions of that exercise of enforcement discretion, or if any of our products otherwise fail to comply with FDA regulatory requirements as enforced, we
would be subject to the applicable requirements of the FDC Act and the FDA’s implementing regulations. The FDA is empowered to impose sanctions for
violations of the FDC Act and the FDA’s implementing regulations, including warning letters, civil and criminal penalties, injunctions, product seizure or
recall, import bans, restrictions on the conduct of our operations and total or partial suspension of production. Any of the aforementioned sanctions could
cause reputational damage, undermine our ability to maintain and increase our revenues, and harm our business, financial condition, and results of
operations. In particular, if we or the FDA discover that any of our products have defects that call into question the accuracy of their results, we may be
required to undertake a retest of all results and analyses provided during the period relevant to the defect, or recall the affected products. The direct costs
incurred in connection with such a recall in terms of management time, administrative, and legal expenses and lost revenue, together with the indirect costs
to our reputation could harm our business, financial condition and results of operations, and our ability to execute our business strategy. While we believe
that we are currently in material compliance with applicable laws and regulations as currently enforced, the FDA or other regulatory agencies may not
agree, and a determination that we have violated these laws or a public announcement that we are being investigated for possible violations of these laws
could adversely affect our business, financial condition, results of operations, and prospects.
Complying with numerous statutes and regulations pertaining to our business is an expensive and time-consuming process, and any failure
to comply could result in substantial penalties.
Our operations may be subject to other extensive federal, state, local, and foreign laws and regulations, all of which are subject to change. These
laws and regulations currently include, among others:
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the federal Anti-Kickback Statute, which prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly
or indirectly, overtly or covertly, in cash or in kind, in return for or to induce such person to refer an individual, or to purchase, lease, order,
arrange for, or recommend purchasing, leasing or ordering, any good, facility, item or service that is reimbursable, in whole or in part, under
a federal healthcare program. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order
to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of
the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes;
the federal Stark physician self-referral law, which prohibits a physician from making a referral for certain designated health services
covered by the Medicare program, including laboratory and pathology services, if the physician or an immediate family member has a
financial relationship with the entity providing the designated health services, and prohibits that entity from billing or presenting a claim for
the designated health services furnished pursuant to the prohibited referral, unless an exception applies. Failure to refund amounts received
as a result of a prohibited referral on a timely basis may constitute a false or fraudulent claim under the False Claims Act;
the “Anti-Markup Rule” and similar state and similar state laws, among other things, prohibits a physician or supplier billing the Medicare
program from marking up the price of a purchased diagnostic service performed by another laboratory or supplier that does not “share a
practice” with the billing physician or supplier. Penalties may apply to the billing physician or supplier if Medicare or another payer is billed
at a rate that exceeds the performing laboratory’s charges to the billing physician or supplier, and the performing laboratory could be at risk
under false claims laws, described below, for causing the submission of a false claim;
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the federal civil and criminal false claims laws, including the False Claims Act, which impose liability on any person or entity that, among
other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government. These laws
can apply to entities that provide information on coverage, coding, and reimbursement of their products and assistance with obtaining
reimbursement to persons who bill payors. Private individuals can bring False Claims Act “qui tam” actions, on behalf of the government
and such individuals, commonly known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or
settlement;
the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or
state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular
provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, biologicals, and medical devices or supplies
that require premarket approval by or notification to the FDA, and for which payment is available under Medicare, Medicaid, or the
Children’s Health Insurance Program (“CHIP”) to report annually to CMS information related to (i) payments and other transfers of value to
physicians and teaching hospitals, and (ii) ownership and investment interests held by physicians and their immediate family members;
the HIPAA fraud and abuse provisions, which created federal civil and criminal statutes that prohibit, among other things, defrauding
healthcare programs, willfully obstructing a criminal investigation of a healthcare offense, and falsifying or concealing a material fact or
making any materially false statements in connection with the payment for healthcare benefits, items or services. Similar to the federal Anti-
Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have
committed a violation;
the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), which prohibits payments for referrals to recovery homes, clinical treatment
facilities, and laboratories. EKRA’s reach extends beyond federal health care programs to include private insurance (i.e., it is an “all payer”
statute);
other federal and state fraud and abuse laws, such as anti-kickback laws, prohibitions on self-referral, fee-splitting restrictions, insurance
fraud laws, prohibitions on the provision of tests at no or discounted cost to induce physician or patient adoption, and false claims acts,
which may extend to services reimbursable by any payer, including private insurers;
the prohibition on reassignment of Medicare claims, which, subject to certain exceptions, precludes the reassignment of Medicare claims to
any other party;
state laws that prohibit other specified practices, such as billing physicians for testing that they order; waiving coinsurance, copayments,
deductibles, and other amounts owed by patients; billing a state Medicaid program at a price that is higher than what is charged to one or
more other payors employing, exercising control over, licensed professionals in violation of state laws prohibiting corporate practice of
medicine and other professions, and prohibitions against the splitting of professional fees with licensed professionals; and
similar foreign laws and regulations that apply to us in the countries in which we operate or may operate in the future.
As a clinical laboratory, our business practices may face additional scrutiny from government regulatory agencies such as the Department of
Justice, the HHS Office of Inspector General (the “OIG”) and CMS. Certain arrangements between clinical laboratories and referring physicians have been
identified in fraud alerts issued by the OIG as implicating the Anti-Kickback Statute. The OIG has stated that it is particularly concerned about these types
of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically are made or strongly influenced by the
physician, with little or no input from patients. Moreover, the provision of payments or other items of value by a clinical laboratory to a referral source
could be prohibited under the Stark Law unless the arrangement meets all criteria of an applicable exception. The government has been active in
enforcement of these laws as they apply to clinical laboratories.
The growth of our business and our expansion outside of the United States may increase the potential of violating these laws or our internal
policies and procedures. The risk of our being found in violation of these or other laws and regulations is further increased by the fact that many have not
been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action brought against us
for violation of these or other laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and
reputational harm and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of these
laws and regulations, we may be subject to any applicable penalty associated with the violation, including significant administrative, civil and criminal
penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs, refunding of payments received by us, integrity
oversight and reporting obligations, and curtailment or cessation of our operations. Any of the foregoing consequences could seriously harm our business
and our financial results.
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Expansion into international markets would subject us to increased regulatory oversight and regulatory, economic, social, health and
political uncertainties, which could cause a material adverse effect on our business, financial position, and results of operations.
We may in the future expand our business and operations into international jurisdictions in which we have limited operating experience,
including with respect to seeking regulatory approvals and marketing and selling products and services. If we expand internationally, our operations in
these jurisdictions may be adversely affected by general economic conditions and economic and fiscal policy, including changes in exchange rates and
controls, interest rates and taxation policies, increased government regulation, social instability, local or regional health crises, and political, economic or
diplomatic developments in the future. Certain jurisdictions have, from time to time, experienced instances of civil unrest and hostilities, both internally
and with neighboring countries. Rioting, military activity, terrorist attacks, or armed hostilities could cause our operations in such jurisdictions to be
adversely affected or suspended. We generally do not have insurance for losses and interruptions caused by terrorist attacks, military conflicts and wars. In
addition, anti-bribery and anti-corruption laws may conflict with some local customs and practices in foreign jurisdictions. Our international operations
may subject us to heightened scrutiny under the FCPA, the UK Bribery Act and similar anti-bribery laws, and could subject us to liability under such laws
despite our best efforts to comply with such laws. As a result of our policy to comply with the FCPA, the UK Bribery Act and similar anti-bribery laws, we
may be at a competitive disadvantage to competitors that are not subject to, or do not comply with, such laws. Further, notwithstanding our compliance
programs, there can be no assurances that our policies will prevent our employees or agents from violating these laws or protect us from any such
violations. Additionally, we cannot predict the nature, scope or impact of any future regulatory requirements that may apply to our international operations
or how foreign governments will interpret existing or new laws. Alleged, perceived, or actual violations of any such existing or future laws by us or due to
the acts of others, may result in criminal or civil sanctions, including contract cancellations or debarment, and damage to our reputation, any of which could
have a material adverse effect on our business.
If we decide to grow our business by developing in vitro diagnostic tests, we may be subject to reimbursement challenges.
The coverage and reimbursement status of newly approved or cleared laboratory tests is uncertain. If we develop in vitro diagnostic tests and
decide to seek reimbursement, and if such tests are inadequately covered by insurance and ineligible for such reimbursement, this could limit our ability to
market any such future tests. The commercial success of future products in both domestic and international markets may depend in part on the availability
of coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and Medicaid programs, managed
care organizations, and other third-party payors. The government and other third-party payors are increasingly attempting to contain health care costs by
limiting both insurance coverage and the level of reimbursement for new diagnostic tests. As a result, they may not cover or provide adequate payment for
any future in vitro diagnostic tests that we develop. These payors may conclude that our products are less safe, less effective, or less cost-effective than
existing or later-introduced products. These payors may also conclude that the overall cost of using one of our tests exceeds the overall cost of using a
competing test, and third-party payors may not approve any future in vitro diagnostic tests we develop for insurance coverage and adequate reimbursement.
We could be adversely affected by violations of the Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), and other worldwide
anti-bribery laws.
We are subject to the FCPA, which prohibits companies and their intermediaries from making payments in violation of law to non-U.S.
government officials for the purpose of obtaining or retaining business or securing any other improper advantage. Other U.S. companies in the medical
device and pharmaceutical fields have faced criminal penalties under the FCPA for allowing their agents to deviate from appropriate practices in doing
business with these individuals. We are also subject to similar anti-bribery laws in the jurisdictions in which we operate, including the United Kingdom’s
Bribery Act of 2010, which also prohibits commercial bribery and makes it a crime for companies to fail to prevent bribery. These laws are complex and
far-reaching in nature, and, as a result, we cannot assure you that we would not be required in the future to alter one or more of our practices to be in
compliance with these laws or any changes in these laws or the interpretation thereof. Any violations of these laws, or allegations of such violations, could
disrupt our operations, involve significant management distraction, involve significant costs and expenses, including legal fees, and could result in a
material adverse effect on our business, prospects, financial condition or results of operations. We could also incur severe penalties, including criminal and
civil penalties, disgorgement, and other remedial measures.
Changes in health care policy could increase our costs, decrease our revenues, and impact sales of and reimbursement for our tests.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (the “ACA”),
became law. This law substantially changed the way health care is financed by both commercial payers and government payers, and significantly impacts
our industry. The ACA contains a number of provisions that are expected to impact the business and operations of our customers, some of which in ways
we cannot currently predict, including those governing enrollment in state and federal health care programs, reimbursement changes, and fraud and abuse,
which will impact existing state and federal health care programs and will result in the development of new programs.
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Among other things, the ACA:
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expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional
individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level,
thereby potentially increasing manufacturers’ Medicaid rebate liability;
established a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical efficacy research
in an effort to coordinate and develop such research; and
established a Center for Medicare & Medicaid Innovation at CMS to test innovative payment and service delivery models to lower
Medicare and Medicaid spending.
Some of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects of
the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has
signed two Executive Orders and other directives to delay the implementation of certain requirements of the ACA. Concurrently, Congress has considered
legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted
laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate
to carry health insurance and delaying the implementation of certain ACA-mandated fees. On December 14, 2018, a Texas U.S. District Court Judge ruled
that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act. While the
Texas U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will have no immediate effect pending appeal of
the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA and our business.
Additional legislation may be enacted that further amends, or repeals, the ACA, which could result in lower numbers of insured individuals, reduced
coverage for insured individuals and adversely affect our and our customers’ business.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. On August 2, 2011, the
Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare payments to providers by 2% per fiscal year, effective on
April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2027 unless additional Congressional action is
taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to
several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to
five years. The Medicare Access and CHIP Reauthorization Act of 2015, enacted on April 16, 2015 (“MACRA”), repealed the formula by which Medicare
made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and a new system of incentive payments
beginning in 2019 that are based on various performance measures and physicians’ participation in alternative payment models such as accountable care
organizations.
In April 2014, Congress passed the Protecting Access to Medicare Act of 2014 (“PAMA”), which included substantial changes to the way in
which clinical laboratory services are paid under Medicare. Under PAMA, laboratories that receive the majority of their Medicare revenues from payments
made under the Medicare Clinical Laboratory Fee Schedule, or the Physician Fee Schedule are required to report to CMS, beginning in 2017 and every
three years thereafter (or annually for “advanced diagnostic laboratory tests”), private payer payment rates and volumes for their tests. CMS will use this
data to calculate a weighted median payment rate for each test, which will be used to establish revised Medicare reimbursement rates for the tests.
Laboratories that fail to report the required payment information may be subject to substantial civil monetary penalties. It is unclear what impact new
quality and payment programs, such as MACRA, or new pricing structures, such as those adopted under PAMA, may have on our business, financial
condition, results of operations, or cash flows.
We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and private payers to reduce costs
while expanding individual healthcare benefits. Certain of these changes could impose additional limitations on the prices we will be able to charge for our
tests, the coverage of or the amounts of reimbursement available for our tests from payers, including commercial payers and government payers.
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If we use hazardous materials in a manner that causes injury, we could be liable for resulting damages.
Our activities currently require the use of hazardous chemicals and biological material. We cannot eliminate the risk of an accidental
environmental release or injury to employees or third parties from the use, storage, handling, or disposal of these materials. In the event of an
environmental release or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance
coverage we may have. Additionally, we are subject on an ongoing basis to federal, state, and local laws and regulations governing the use, storage,
handling, and disposal of these materials and specified waste products. The cost of maintaining compliance with these laws and regulations may become
significant and our failure to comply may result in substantial fines or other consequences, and either could negatively affect our operating results.
Risks Related to Our Intellectual Property
Litigation or other proceedings or third-party claims of intellectual property infringement, misappropriation or other violations may require
us to spend significant time and money, and could in the future prevent us from selling our tests or impact our stock price, any of which
could have a material adverse effect.
Our commercial success will depend in part on our avoiding infringement of patents and infringement, misappropriation or other violations of
other proprietary rights of third parties, including for example the intellectual property of competitors. There is extensive intellectual property litigation
involving the biotechnology and pharmaceutical industries and genetic sequencing technology. Our activities may be subject to claims that we infringe or
otherwise violate patents owned or controlled by third parties. Numerous U.S. and foreign patents and pending patent applications exist in the genetic
testing market and are owned by third parties. We cannot assure you that our operations do not, or will not in the future, infringe existing or future patents.
For example, we are aware of several third-party issued U.S. patents and pending patent applications with claims relating to genetic sequencing technology
and methodology that may be asserted against us and may be construed to encompass our products and services, including ACE ImmunoID and ImmunoID
NeXT technology. In order to avoid infringing these third-party patents, we may find it necessary to or prudent to initiate invalidity proceedings against
such patents or to obtain licenses from such third-party intellectual property holders. If we are not able to invalidate such patents or obtain or maintain a
license on commercially reasonable terms and such third parties assert infringement claims against us, we may be prevented from exploiting our technology
and our business, financial condition, results of operations, and prospects may be materially and adversely affected. We may also be unaware of patents that
a third party, including for example a competitor in the genetic testing market, might assert are infringed by our business. There may also be patent
applications that, if issued as patents, could be asserted against us. Patent applications in the United States and elsewhere are typically published
approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date.
Certain U.S. patent applications that will not be filed outside the United States can remain confidential until patents issue. Therefore, patent applications
covering our products, services, or technologies could have been filed by third parties without our knowledge. Additionally, pending patent applications
that have been published can, subject to certain limitations, be later amended in a manner that could cover our products, services, technologies, and their
use. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history and can
involve other factors such as expert opinion. Our interpretation of the relevance or the scope of claims in a patent or a pending application may be incorrect,
which may negatively impact our ability to market our products and services. Further, we may incorrectly determine that our technologies, products, or
services are not covered by a third-party patent or may incorrectly predict whether a third party’s pending patent application will issue with claims of
relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may
negatively impact our ability to develop and market our products or services.
Third-party intellectual property right holders may also actively bring infringement or other intellectual property-related claims against us, even
if we have received patent protection for our technologies, products, and services. Regardless of the merit of third parties claims against us for
infringement, misappropriation or violations of their intellectual property rights, such third parties may seek and obtain injunctive or other equitable relief,
which could effectively block our ability to perform our tests. Further, if a patent infringement suit were brought against us, we could be forced to stop or
delay our development or sales of any tests or other activities that are the subject of such suit. Defense of these claims, even if such claims are resolved in
our favor, could cause us to incur substantial expenses and be a substantial diversion of our employee resources even if we are ultimately successful. Any
adverse ruling or perception of an adverse ruling in defending ourselves could have a material adverse impact on our cash position and stock price. Such
litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales,
marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of
our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources
and more mature and developed intellectual property portfolios.
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As we continue to commercialize our tests in their current or an updated form, launch different and expanded tests and enter new markets, other
competitors might claim that our tests infringe, misappropriate or violate their intellectual property rights as part of business strategies designed to impede
our successful commercialization and entry into new markets. If such a suit were brought, regardless of merit, there is no assurance that a court would find
in our favor on questions of infringement, validity, enforceability or priority. Even if we are successful in defending against such suit, we could incur
substantial costs and diversion of the attention of our management and technical personnel in defending ourselves against such claims. A court of
competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable, and infringed, which could materially and adversely
affect our ability to commercialize any products, services or technologies we may develop and any other technologies covered by the asserted third-party
patents and any adverse ruling or perception of an adverse ruling in defending ourselves could have a material adverse impact on our cash position and
stock price. If we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, and we are unsuccessful in
demonstrating that such rights are invalid or unenforceable, we may be required to pay substantial damages, including treble damages and attorneys’ fees
for willful infringement; obtain one or more licenses from third parties in order to continue developing and marketing our products and technology, which
may not be available on commercially reasonable terms (if at all) or may be non-exclusive, thereby giving our competitors and other third parties access to
the same technologies licensed to us; pay substantial royalties and other fees; and redesign any infringing tests or other activities, which may be impossible
or require substantial time and monetary expenditure, or be prohibited from commercializing certain tests, all of which could have a material adverse effect
on our business, financial condition, results of operations, and prospects.
Where we collaborate with third parties in the development of technology, our collaborators may not properly maintain or defend our intellectual
property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or
proprietary information. Further, collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential
liability. Also, we may be obligated under our agreements with our collaborators, licensors, suppliers and others to indemnify and hold them harmless for
damages arising from intellectual property infringement by us.
If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
In the future, we may identify additional third-party intellectual property we may need to license in order to engage in our business, including to
develop or commercialize new products or services. However, such licenses may not be available on acceptable terms or at all. Even if such licenses are
available, we may be required to pay the licensor substantial royalties based on sales of our products and services. Such royalties are a component of the
cost of our products or services and may affect the margins on our products and services. In addition, such licenses may be nonexclusive, which could give
our competitors access to the same intellectual property licensed to us. If we are unable to enter into the necessary licenses on acceptable terms or at all, if
any necessary licenses are subsequently terminated, if our licensors fail to abide by the terms of the licenses, if our licensors fail to prevent infringement by
third parties, or if the licensed patents or other rights are found to be invalid or unenforceable, our business, financial condition, results of operations, and
prospects could be materially and adversely affected.
If licenses to third-party intellectual property rights are or become required for us to engage in our business, the rights may be non-exclusive,
which could give our competitors access to the same technology or intellectual property rights licensed to us. Moreover, we could encounter delays in the
introduction of tests while we attempt to develop alternatives. Defense of any lawsuit or failure to obtain any of these licenses on favorable terms could
prevent us from commercializing tests, which could materially affect our ability to grow and thus adversely affect our business and financial condition.
Developments or uncertainty in the patent statute, patent case law or U.S. Patent and Trademark Office (“USPTO”), rules and regulations
may impact the validity, scope or enforceability of our patent rights, thereby impairing our ability to protect our products.
Our patent rights, their associated costs, and the enforcement or defense of such patent rights may be affected by developments or uncertainty in
the patent statute, patent case law or USPTO rules and regulations.
There are a number of recent changes to the patent laws that may have a significant impact on our ability to protect our technology and enforce
our intellectual property rights. For example, the Leahy-Smith America Invents Act (the “AIA”) enacted within the last several years involves significant
changes in patent legislation. These include provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. As an
example, assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was
entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. On or after March 16, 2013, under the
AIA, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, means that the
party that is first to file in the United States generally is awarded the patent rights, regardless of whether such party invented the claimed invention first.
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The AIA also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent
litigation. These include allowing third party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the
validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because
of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent
claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same
evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO
procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.
The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or
defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Further, the standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. For
example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology patents. As such, we
do not know the degree of future protection that we will have on our technologies, products, and services. While we will endeavor to try to protect our
technologies, products, and services with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming,
expensive, and sometimes unpredictable.
In addition, the patent position of companies engaged in the development and commercialization of diagnostic tests is particularly uncertain.
Various courts, including the Supreme Court have rendered decisions that affect the scope of patentability of certain inventions or discoveries relating to
certain diagnostic tests and related methods. These decisions state, among other things, that a patent claim that recites an abstract idea, natural phenomenon
or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable. Precisely what constitutes a
law of nature or abstract idea is uncertain, and it is possible that certain aspects of genetic diagnostics tests would be considered natural laws. Accordingly,
the evolving case law in the United States may adversely affect our ability to obtain patents and may facilitate third-party challenges to any owned or
licensed patents. The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and we
may encounter difficulties in protecting and defending such rights in foreign jurisdictions. The legal systems of many other countries do not favor the
enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop
the infringement of our patents in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert
our efforts and attention from other aspects of our business.
Patent terms may be inadequate to protect our competitive position for an adequate amount of time.
Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective non-provisional
filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our
technologies, products, and services are obtained, once the patent life has expired, we may be open to competition from competitive products. Our issued
patents will expire on dates ranging from 2033 to 2037, subject to any patent extensions that may be available for such patents. If patents are issued on our
pending patent applications, the resulting patents are projected to expire on dates ranging from 2033 to 2040. In addition, although upon issuance in the
United States a patent’s life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain
delays caused by the patent applicant during patent prosecution. If we do not have sufficient patent life to protect our technologies, products and services,
our competitive position, business, financial condition, results of operations, and prospects will be adversely affected.
If we are not able to obtain and enforce patent protection for any products we develop and for our technologies, or if the scope of patent
protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize products and
technology similar or identical to ours, and our ability to successfully commercialize our products, services, and technologies may be
adversely affected.
We have applied, and we intend to continue applying, for patents covering such aspects of our technologies as we deem appropriate. However,
the patent process is expensive, time consuming and complex, and we may not be able to apply for patents on certain aspects of our services, products, and
other technologies in a timely fashion, at a reasonable cost, in all jurisdictions or at all, and any potential patent coverage we obtain may not be sufficient to
prevent substantial competition.
Moreover, the patent position of biotechnology companies can be highly uncertain because it involves complex legal and factual questions for
which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged
to date in the United States or elsewhere. Courts frequently render opinions in the biotechnology field that may affect the patentability of certain inventions
or discoveries, including opinions that may affect the patentability of methods for analyzing nucleic acid sequences.
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Others may independently develop similar or alternative technologies or design around technologies for which we may not be able to obtain
patent protection. In addition, any patent applications we file may be challenged and may not result in issued patents or may be invalidated, rendered
unenforceable or narrowed in scope after they are issued, and there is no guarantee any of our issued patents include or will include claims that are
sufficiently broad to cover our products, services and other technologies or to provide meaningful protection from our competitors. Consequently, we do
not know whether any of our platform advances, products, services, and other technologies will be protectable or remain protected by valid and enforceable
patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-
infringing manner.
Even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for
our technologies, products, and services, or prevent others from designing around our claims. Any finding that our patents or applications are invalid,
unpatentable, or unenforceable could harm our ability to prevent others from practicing the related technology, and a finding that others have inventorship
or ownership rights to our patents and applications could require us to obtain certain rights to practice related technologies, which may not be available on
favorable terms, if at all. If we initiate lawsuits to protect or enforce our patents, or litigate against third-party claims, which would be expensive, and, if we
lose, we may lose some of our intellectual property rights. Furthermore, these lawsuits may divert the attention of our management and technical personnel.
Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects.
Once granted, patents may remain open to opposition, interference, re-examination, post-grant review, inter partes review, nullification or
derivation action in court or before patent offices or similar proceedings for a given period after allowance or grant, during which time third parties can
raise objections against such initial grant. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may be
compelled to limit the scope of the granted claims thus attacked, or may lose the granted claims altogether. An adverse determination in any such
proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and
compete directly with us, without payment to us, or result in our inability to commercialize our products, services and technologies without infringing
third-party patent rights. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the
eventual outcome is favorable to us. If the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the
outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products or technologies. In
addition, there can be no assurance that:
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others will not or may not be able to make, use, offer to sell, or sell tests that are the same as or similar to our products or services but that
are not covered by the claims of the patents that we own or license;
we or our future licensors or collaborators are the first to make the inventions covered by each of our issued patents and pending patent
applications that we own or license;
we or our future licensors or collaborators are the first to file patent applications covering certain aspects of our inventions;
others will not independently develop similar or alternative technologies or duplicate any of our technologies without infringing our
intellectual property rights;
a third party may not challenge our patents and, if challenged, a court would hold that our patents are valid, enforceable, and infringed;
any issued patents that we own or may license will provide us with any competitive advantages, or will not be challenged by third parties;
we may develop or in-license additional proprietary technologies that are patentable;
pending patent applications that we own or may license will lead to issued patents;
the patents of others will not have a material or adverse effect on our business, financial condition, results of operations, and prospects; and
our competitors do not conduct research and development activities in countries where we do not have enforceable patent rights and then
use the information learned from such activities to develop competitive products for sale in our major commercial markets.
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The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Some of our patents or patent applications may
be challenged at a future point in time in opposition, derivation, reexamination, inter partes review, post-grant review, or interference proceedings. Any
successful opposition to these patents or any other patents owned by or, if applicable in the future, licensed to us could deprive us of rights necessary for the
practice of our technologies or the successful commercialization of any products or technologies that we may develop, which could lead to increased
competition to our business and harm our business. Since patent applications in the United States and most other countries are confidential for a period of
time after filing, we cannot be certain that we or our licensors were the first to file any patent application related to our technologies, products, or services.
Furthermore, an interference proceeding can be provoked by a third party or instituted by the USPTO to determine who was the first to invent any of the
subject matter covered by the patent claims of our applications for any application with an effective filing date before March 16, 2013.
Where we obtain licenses from or collaborate with third parties, in some circumstances, we may not have the right to control the preparation,
filing, and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. We may also require the
cooperation of our licensors and collaborators to enforce any licensed patent rights, and such cooperation may not be provided. Therefore, these patents and
applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Moreover, if we do obtain necessary
licenses, we will likely have obligations under those licenses, and any failure to satisfy those obligations could give our licensor the right to terminate the
license. Termination of a necessary license could have a material adverse impact on our business.
It is also possible that we fail to file patent applications covering inventions made in the course of development and commercialization activities
before a competitor or another third party files a patent application covering, or publishes information disclosing, a similar, independently-developed
invention. Such competitor’s patent application may pose obstacles to our ability to obtain or limit the scope of patent protection we may obtain. Although
we enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and
development output, such as our employees, collaborators, contract manufacturers, consultants, advisors, and other third parties, any of these parties may
breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition,
publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other
jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we or our licensors
were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or were the first to file for patent protection
of such inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings, inter
partes review proceedings, or other post-grant proceedings declared by the USPTO that could result in substantial cost to us. The outcome of such
proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to
the patent laws of the United States allow for various post-grant opposition proceedings, such as inter partes review proceedings, that have not been
extensively tested, and their outcome is therefore uncertain. An unfavorable outcome could require us to cease using the related technology or to attempt to
license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable
terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology. Furthermore, if third parties bring these
proceedings against our patents, we could experience significant costs and management distraction.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time
consuming, and unsuccessful.
Competitors may also infringe our patents or the patents of our licensing partners. In addition, our patents or the patents of our licensors may
become involved in inventorship, priority, or validity disputes. To counter or defend against such claims can be expensive and time consuming. In an
infringement proceeding, a court may refuse to stop the other party from using the technology at issue on the grounds that our owned and in-licensed
patents do not cover the technology in question. Further in such proceedings, the defendant could counterclaim that our asserted patent covering our
product is invalid or unenforceable, and the court may agree that our asserted patent is invalid or unenforceable. In patent litigation in the United States,
defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any
of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an
allegation that someone connected with the prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement,
during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of
litigation. Such mechanisms include re-examination, post grant review, inter partes review, and equivalent proceedings in foreign jurisdictions (e.g.,
opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product. The
outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be
certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. An adverse result in any litigation or
other proceeding could put one or more of our owned or in-licensed patents at risk of being invalidated or interpreted narrowly. Such a loss of patent
protection could have a material adverse impact on our business. Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
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Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant
expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings,
motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a
substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the
resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other
resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings
more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties
resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the
marketplace.
If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed.
We seek protection for certain aspects of our technologies, products, and services through the filing of patents, registration of copyrights, and use
of non-disclosure agreements. In addition, we also expect to rely on trade secrets and proprietary know-how protection for our confidential and proprietary
information, and we have taken security measures to protect this information. These measures, however, may not provide adequate protection for our trade
secrets, know-how, or other confidential information. Among other things, we seek to protect our trade secrets, know-how, and confidential information by
entering into confidentiality agreements with parties who have access to them, such as our employees, collaborators, contract manufacturers, consultants,
advisors, and other third parties. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our
trade secrets or proprietary technology and processes. Moreover, there can be no assurance that any confidentiality agreements that we have with our
employees, consultants, or other third parties will provide meaningful protection for our trade secrets, know-how, and confidential information or will
provide adequate remedies in the event of unauthorized use or disclosure of such information. Despite these efforts, any of these parties may breach the
agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will
be effective. Accordingly, there also can be no assurance that our trade secrets or know-how will not otherwise become known or be independently
developed by competitors.
Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the
outcome is unpredictable. In addition, trade secrets may be independently developed by others in a manner that could prevent legal recourse by us. If any of
our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was
independently developed by a competitor, our competitive position would be materially and adversely harmed.
Trade secrets and know-how can be difficult to protect as trade secrets and know-how will over time be disseminated within the industry through
independent development, the publication of journal articles, and the movement of personnel skilled in the art from company to company or academic to
industry scientific positions. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we
would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.
Because from time to time we expect to rely on third parties in the development, manufacture and distribution of our products and provision of our
services, we must, at times, share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements
and, if applicable, material transfer agreements, license agreements, collaboration agreements, supply agreements, consulting agreements, or other similar
agreements with our advisors, employees, collaborators, licensors, suppliers, third-party contractors, and consultants prior to beginning research or
disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including
our trade secrets and know-how. Despite the contractual provisions employed when working with third parties, the need to share trade secrets, know-how,
and other confidential information increases the risk that such trade secrets and know-how become known by our competitors, are inadvertently
incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on
our know-how and trade secrets, a competitor’s discovery of our trade secrets or know-how, or other unauthorized use or disclosure would impair our
competitive position and may have an adverse effect on our business and results of operations.
In addition, these agreements typically restrict the ability of our advisors, employees, collaborators, licensors, suppliers, third-party contractors,
and consultants to publish data potentially relating to our trade secrets or know-how, although our agreements may contain certain limited publication
rights. Despite our efforts to protect our trade secrets and know-how, our competitors may discover our trade secrets or know-how, either through breach of
our agreements with third parties, independent development, or publication of information by any of our third-party collaborators. A competitor’s discovery
of our trade secrets or know-how would impair our competitive position and have a material adverse impact on our business.
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We may not be able to enforce our intellectual property rights throughout the world.
Filing, prosecuting, maintaining, defending, and enforcing patents on our products, services, and technologies in all countries throughout the
world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in
the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and,
further, may export otherwise infringing products to territories where we have patent protection or licenses but enforcement is not as strong as that in the
United States. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to
prevent them from competing. In addition, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United
States, and many companies have encountered significant challenges in establishing and enforcing their proprietary rights outside of the United States.
These challenges can be caused by the absence or inconsistency of the application of rules and methods for the establishment and enforcement of
intellectual property rights outside of the United States. In addition, the legal systems of some countries, particularly developing countries, do not favor the
enforcement of patents and other intellectual property protection, especially those relating to healthcare. This could make it difficult for us to stop the
infringement of our patents, if obtained, or the misappropriation of our other intellectual property rights. For example, many foreign countries, including
European Union countries, India, Japan, and China, have compulsory licensing laws under which a patent owner may be compelled under specified
circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government
agencies or government contractors. In these countries, patents may provide limited or no benefit given that we may have limited remedies available if
patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents and limit our
potential revenue opportunities. Furthermore, patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-
consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the
benefit of patent protection in such countries.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. In addition, changes in the
law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our products, services
and other technologies and the enforcement of intellectual property. Any of the foregoing could have a material adverse effect on our competitive position,
business, financial condition, results of operations, and prospects.
Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other
requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with
these requirements.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and
other provisions during the patent application and prosecution process. Periodic maintenance fees, renewal fees, annuity fees, and various other
governmental fees on patents and/or applications will be due to be paid to the USPTO and various other governmental patent agencies outside of the United
States in several stages over the lifetime of the patents and/or applications. We employ reputable professionals and rely on such third parties to help us
comply with these requirements and effect payment of these fees with respect to the patents and patent applications that we own. Noncompliance events
that could result in abandonment or lapse of a patent or patent application include failure to respond to official communications within prescribed time
limits, non-payment of fees and failure to properly legalize and submit formal documents. In many cases, an inadvertent lapse can be cured by payment of a
late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or
lapse of a patent or patent application, resulting in loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the
market earlier than would otherwise have been the case, which could have a material adverse effect on our competitive position, business, financial
condition, results of operations, and prospects.
Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated
trade secrets.
We employ individuals who were previously employed or otherwise engaged with universities or genetic testing, diagnostic or other healthcare
companies, including our competitors or potential competitors.
Although we have policies to ensure that our employees and consultants do not use the proprietary information or know-how of others in their
work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used or disclosed intellectual property,
including trade secrets or other proprietary information, of a former employer or other third parties. Further, we may be subject to ownership disputes in the
future arising, for example, from conflicting obligations of consultants or others who are involved in developing our intellectual property. Litigation may be
necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a
distraction to management and other employees. Such claims could have a material adverse effect on our business, financial condition, results of
operations, and prospects.
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In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual
property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in
fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the
assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to
determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial
condition, results of operations, and prospects.
Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell our products
and services, and subject us to possible litigation.
A portion of the products or technologies licensed, developed, and/or distributed by us incorporate so-called “open source” software and we may
incorporate open source software into other products in the future. Such open source software is generally licensed by its authors or other third parties
under open source licenses. Some open source licenses contain requirements that we disclose source code for modifications we make to the open source
software and that we license such modifications to third parties at no cost. In some circumstances, distribution of our software in connection with open
source software could require that we disclose and license some or all of our proprietary code in that software, as well as distribute our products or provide
our services that use particular open source software at no cost to the user. We monitor our use of open source software in an effort to avoid uses in a
manner that would require us to disclose or grant licenses under our proprietary source code; however, there can be no assurance that such efforts will be
successful. Open source license terms are often ambiguous and such use could inadvertently occur. There is little legal precedent governing the
interpretation of many of the terms of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations
regarding our products and technologies. Companies that incorporate open source software into their products have, in the past, faced claims seeking
enforcement of open source license provisions and claims asserting ownership of open source software incorporated into their product. If an author or other
third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur
significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or
be enjoined from the distribution of our products. In addition, if we combine our proprietary software with open source software in certain ways, under
some open source licenses, we could be required to release the source code of our proprietary software, which could substantially help our competitors
develop products that are similar to or better than ours and otherwise adversely affect our business. These risks could be difficult to eliminate or manage,
and, if not addressed, could have a material adverse effect on our business, financial condition, and results of operations.
If we fail to comply with our obligations under license or technology agreements with third parties, we may be required to pay damages and
we could lose license rights that are critical to our business.
We license certain intellectual property that is important to our business, and in the future we may enter into additional agreements that provide
us with licenses to valuable intellectual property or technology. For example, our agreements with third parties, such as Illumina, include certain non-
exclusive license rights that are essential to the operation of our business as it is currently conducted. If we fail to comply with any of the obligations under
our license agreements, we may be required to pay damages and the licensor may have the right to terminate the license. Termination by the licensor would
cause us to lose valuable rights, and could prevent us from selling our products and services, or inhibit our ability to commercialize future products and
services. Our business would suffer if any current or future licenses terminate, if the licensors fail to abide by the terms of the license, if the licensors fail to
enforce licensed patents against infringing third parties, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to
enter into necessary licenses on acceptable terms. In addition, our rights to certain technologies, including those of Illumina, are licensed to us on a non-
exclusive basis. The owners of these non-exclusively licensed technologies are therefore free to license them to third parties, including our competitors, on
terms that may be superior to those offered to us, which could place us at a competitive disadvantage. Moreover, our licensors may own or control
intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or
otherwise violating the licensor’s rights.
Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to
develop and commercialize our products.
Any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the
efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:
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collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations;
collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or
commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products,
availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products;
collaborators with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or
otherwise not perform satisfactorily in carrying out these activities;
we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;
collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary
information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or
proprietary information or expose us to potential liability;
disputes may arise between us and a collaborator that causes the delay or termination of the research, development, or commercialization of
our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or
commercialization of the applicable current or future products;
collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such
cases, we would not have the exclusive right to develop or commercialize such intellectual property; and
collaborators’ sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal
proceedings.
If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property
rights we have, we may have to abandon development of that program and our business and financial condition could suffer.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We or our licensors may be subject to claims that former employees, collaborators, or other third parties have an interest in our patents, trade
secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors may have inventorship disputes arise from conflicting
obligations of employees, consultants, or others who are involved in developing our products, services, or technologies. Litigation may be necessary to
defend against these and other claims challenging inventorship or our licensors’ ownership of our owned or in-licensed patents, trade secrets, or other
intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights,
such as exclusive ownership of, or right to use, intellectual property that is important to our products, services, or technologies. Even if we are successful in
defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing
could have a material adverse effect on our business, financial condition, results of operations, and prospects.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of
interest and our business may be adversely affected.
Our trademarks or trade names may be challenged, infringed, circumvented, or declared generic or determined to be infringing on other marks.
We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name
recognition by potential partners or customers in our markets of interest. During trademark registration proceedings, we may receive rejections. Although
we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in
comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel
registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings.
If we are unable to establish brand name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business
may be adversely affected.
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Risks Related to Our Common Stock
The market price of our common stock may be volatile or may decline steeply or suddenly regardless of our operating performance, we may
not be able to meet investor or analyst expectations, and you may lose all or part of your investment.
The market price of our common stock may fluctuate or decline significantly in response to numerous factors, many of which are beyond our
control, including:
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actual or anticipated fluctuations in our operating results;
failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
issuance of new or updated research reports by securities analysts or changed recommendations for our stock;
competition from existing tests or new tests that may emerge;
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, capital
commitments, or by or pertaining to our customers, particularly the VA MVP;
the timing and amount of our investments in the growth of our business;
actual or anticipated changes in regulatory oversight of our business or issues we may face with regulators;
additions or departures of key management or other personnel;
inability to obtain additional funding;
sales of our common stock by us or our stockholders in the future;
disputes or other developments related to our intellectual property or other matters, including litigation; and
general economic, industry, and market conditions, including factors unrelated to our operating performance or the operating performance
of our competitors.
In addition, the stock market in general, and the market for life sciences companies in particular, has experienced extreme price and volume
fluctuations that have often been unrelated or disproportionate to the operating performance of those companies, including very recently in connection with
the ongoing COVID-19 outbreak which has resulted in depressed stock prices for many companies notwithstanding the lack of a fundamental change in
their underlying business models or prospects. Broad market and industry factors may seriously affect the market price of our common stock, regardless of
our actual operating performance. In addition, in the past, following periods of volatility in the overall market and the market price of a particular
company’s securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result
in substantial costs and a diversion of our management’s attention and resources.
Moreover, because of these fluctuations, comparing our operating results on a period-to-period basis may not be meaningful. You should not rely
on our past results as an indication of our future performance. This variability and unpredictability could also result in our failing to meet the expectations
of industry or financial analysts or investors for any period. If our revenues or operating results fall below the expectations of analysts or investors or below
any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our
common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated revenues or
earnings forecasts that we may provide.
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Our quarterly results may fluctuate significantly, which could adversely impact the value of our common stock.
Our quarterly results of operations, including our revenue, gross margin, profitability, and cash flows, may vary significantly in the future, and
period-to-period comparisons of our operating results may not be meaningful. Accordingly, our quarterly results should not be relied upon as an indication
of future performance. Our quarterly financial results may fluctuate as a result of a variety of factors, many of which are outside of our control. For
example, the VA and other large customers are not obliged to deliver tissue samples or other specimen to us at any particular time or at all. The rate at
which we receive tissue samples or other specimen can vary dramatically from quarter to quarter, and is difficult or impossible for us to accurately forecast.
Our receipt and processing of tissue samples and other specimen from our customers leads to our recognition of revenue, and as such the variable rates of
delivery of customer samples will lead to variations in our revenues from quarter to quarter. Fluctuations in quarterly results may adversely impact the
value of our common stock. Factors that may cause fluctuations in our quarterly financial results include, without limitation, those listed elsewhere in this
“Risk Factors” section. We also may face competitive pricing pressures, and we may not be able to maintain our pricing in the future, which would
adversely affect our operating results.
Insiders may exercise significant control over our company and will be able to influence corporate matters.
Based solely on the most recent Schedules 13G and 13D filed with the SEC, reports filed with the SEC under Section 16 of the Exchange Act,
and our outstanding shares of common stock as of December 31, 2019, our directors, executive officers and their affiliates and holders of greater than five
percent of our outstanding common stock beneficially owned approximately 39.5% of our outstanding capital stock as of December 31, 2019. As a result,
these stockholders, acting together, will be able to exercise significant influence over our management and affairs and matters requiring stockholder
approval, including the election of directors and approval of significant corporate transactions, such as mergers, consolidations or the sale of substantially
all of our assets. This concentration of ownership may have the effect of delaying or preventing a third party from acquiring control of our company and
could adversely affect the market price of our common stock, and may not be in the best interests of our other stockholders.
Future sales of shares by existing stockholders, or the perception that such sales could occur, could cause our stock price to decline.
Sales of a substantial number of shares of our common stock into the public market, including sales by members of our management or board of
directors or entities affiliated with such members, could occur at any time. These sales, or the perception in the market that the holders of a large number of
shares intend to sell shares, could reduce the market price of our common stock and could impair our ability to raise capital through the sale of additional
equity or equity-related securities. We are unable to predict the effect that such sales may have on the prevailing market price of our common stock. As of
December 31, 2019, we had 31,243,029 shares of common stock outstanding, all of which shares are eligible for sale in the public market, subject in some
cases to the volume limitations and manner of sale and other requirements under Rule 144. In addition, upon issuance, shares of common stock subject to
outstanding options under our stock option plans as of December 31, 2019 will become eligible for sale in the public market in the future, subject to certain
legal and contractual limitations. Moreover, holders of up to an aggregate of 18,790,983 shares of our common stock have the right to require us to register
these shares under the Securities Act pursuant to an investors’ rights agreement. If our existing stockholders sell substantial amounts of our common stock
in the public market, or if the public perceives that such sales could occur, this could have an adverse effect on the market price of our common stock.
An active trading market for our common stock may not be sustained.
Our common stock is currently listed on The Nasdaq Global Market under the symbol “PSNL.” However, we cannot assure you that an active
trading market for our common stock will be sustained. Accordingly, we cannot assure you of the liquidity of any trading market, your ability to sell your
shares of our common stock when desired, or the prices that you may obtain for your shares. Further, an inactive market may also impair our ability to raise
capital by selling our common stock and may impair our ability to enter into strategic partnerships or acquire businesses, products, or technologies using
our common stock as consideration.
We do not currently intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will
depend on appreciation of the value of our common stock.
We have never declared or paid cash dividends on our capital stock. We currently intend to retain any future earnings to finance the operation and
expansion of our business, and we do not expect to pay any cash dividends on our common stock in the foreseeable future. In addition, our ability to pay
cash dividends on our capital stock is limited by our credit agreement and may be prohibited or limited by the terms of any future debt financing
arrangement. As a result, any investment returns on our common stock will depend upon increases in the value for our common stock, which are not
certain.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could
result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.
In the future, we may sell common stock, rights to purchase common stock, convertible securities, or other equity securities in one or more
transactions at prices and in a manner we determine from time to time. We also expect to issue common stock to employees, directors, and consultants
pursuant to our equity incentive plans. If we sell common stock, rights to purchase common stock, convertible securities, or other equity securities in
subsequent transactions, or common stock is issued pursuant to equity
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incentive plans, investors may be materially diluted. In addition, new investors in such subsequent transactions could gain rights, preferences, and
privileges senior to those of holders of our common stock.
If securities or industry analysts do not publish research or reports about our business, or publish inaccurate or unfavorable research about
our business, our stock price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that equity research analysts publish about us and our
business. We do not control these analysts or the content and opinions included in their reports. Securities analysts may elect not to provide research
coverage of our company, and such lack of research coverage may adversely affect the market price of our common stock. The price of our common stock
could also decline if one or more equity research analysts downgrade our common stock or issue other unfavorable commentary or cease publishing reports
about us or our business. If one or more equity research analysts cease coverage of our company, we could lose visibility in the market, which in turn could
cause our stock price to decline.
Our ability to use net operating losses to offset future taxable income may be subject to limitations.
As of December 31, 2019, we had federal and state net operating loss carryforwards of approximately $114.9 million and approximately $72.2
million, respectively. Certain of our federal and state net operating loss carryforwards will begin to expire, if not utilized, beginning in 2031. These net
operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the Tax Cuts and Jobs Act, federal net
operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is
limited. It is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act. In addition, under Section 382 of the Code, and
corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by
value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change
tax attributes (including certain tax credits) to offset its post-change income or taxes may be limited. We may experience ownership changes in the future as
a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our
net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations.
Holders of our common stock could be adversely affected if we issue preferred stock.
Pursuant to our amended and restated certificate of incorporation, our board of directors is authorized to issue up to 10,000,000 shares of
preferred stock without any action on the part of our stockholders. Our board of directors will also have the power, without stockholder approval, to set the
terms of any series of preferred stock that may be issued, including voting rights, dividend rights, preferences over our common stock with respect to
dividends or in the event of a dissolution, liquidation, or winding up, and other terms. In the event that we issue preferred stock in the future that has
preferences over our common stock with respect to payment of dividends or upon our liquidation, dissolution, or winding up, or if we issue preferred stock
that is convertible into our common stock at greater than a one-to-one ratio, the voting and other rights of the holders of our common stock or the market
price of our common stock could be adversely affected.
Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a
merger, tender offer, or proxy contest difficult, thereby depressing the trading price of our common stock.
Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could depress the trading price of
our common stock by acting to discourage, delay or prevent a change of control of our company or changes in our management that the stockholders of our
company may deem advantageous. These provisions include the following:
•
•
•
•
•
•
•
establish a classified board of directors so that not all members of our board of directors are elected at one time;
authorize the issuance of “blank check” preferred stock that our board of directors could use to implement a stockholder rights plan;
permit the board of directors to establish the number of directors and fill any vacancies and newly-created directorships;
provide that directors may only be removed for cause;
require super-majority voting to amend some provisions in our certificate of incorporation and bylaws;
eliminate the ability of our stockholders to call special meetings of stockholders;
prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;
53
•
•
•
provide that the board of directors is expressly authorized to make, alter, or repeal our bylaws;
restrict the forum for certain litigation against us to Delaware; and
establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon
by stockholders at annual stockholder meetings.
Any provision of our amended and restated certificate of incorporation or amended and restated bylaws, or Delaware law that has the effect of
delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and
could also affect the price that some investors are willing to pay for our common stock.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district
courts of the United States will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our
stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the
following types of actions or proceedings under Delaware statutory or common law:
•
•
•
•
any derivative action or proceeding brought on our behalf;
any action asserting a breach of fiduciary duty;
any action asserting a claim against us arising under the Delaware General Corporation Law, our amended and restated certificate of
incorporation, or our amended and restated bylaws; and
any action asserting a claim against us governed by the internal affairs doctrine.
This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S.
federal courts have exclusive jurisdiction.
Our amended and restated certificate of incorporation further provides that the federal district courts of the United States will be the exclusive
forum for resolving any complaint asserting a cause of action arising under the Securities Act, subject to and contingent upon a final adjudication in the
State of Delaware of the enforceability of such exclusive forum provision.
These exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us
or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees. If a court were to
find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may
incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business. For example, the Court of
Chancery of the State of Delaware recently determined that a provision stating that U.S. federal district courts are the exclusive forum for resolving any
complaint asserting a cause of action arising under the Securities Act is not enforceable. However, this decision is being reviewed and may be ultimately
overturned by the Delaware Supreme Court.
The requirements of being a public company may strain our resources, result in litigation and divert management’s attention.
As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing
requirements of The Nasdaq Global Market and other applicable securities rules and regulations. Complying with these rules and regulations has increased
and will increase our legal and financial compliance costs, make some activities more difficult, time-consuming, or costly and increase demand on our
systems and resources, particularly after we are no longer an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012
(the “JOBS Act”). The Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and
operating results. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control
over financial reporting. We are required to disclose changes made in our internal control and procedures on a quarterly basis. In order to maintain and, if
required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and
management oversight may be required. As a result, management’s attention may be diverted from other business concerns, which could adversely affect
our business and operating results. We will need to hire additional employees or engage outside consultants to comply with these requirements, which will
increase our costs and expenses.
In addition, changing laws, regulations, and standards relating to corporate governance and public disclosure are creating uncertainty for public
companies, increasing legal and financial compliance costs and making some activities more time-consuming.
54
These laws, regulations, and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application
in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding
compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply
with evolving laws, regulations, and standards, and this investment will result in increased general and administrative expenses and a diversion of
management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and
standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory
authorities may initiate legal proceedings against us and our business may be adversely affected. By disclosing information in this prospectus and in filings
required of a public company, our business and financial condition will become more visible, which we believe may result in threatened or actual litigation,
including by competitors and other third parties. If those claims are successful, our business could be seriously harmed. Even if the claims do not result in
litigation or are resolved in our favor, the time and resources needed to resolve them could divert our management’s resources and seriously harm our
business.
We also expect that being a public company and these new rules and regulations will make it more expensive for us to obtain director and officer
liability insurance and, in the future, we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors
could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and
compensation committee, and qualified executive officers.
In addition, as a result of our disclosure obligations as a public company, we will have reduced strategic flexibility and will be under pressure to
focus on short-term results, which may materially and adversely affect our ability to achieve long-term profitability.
We are an emerging growth company, and any decision on our part to comply only with certain reduced reporting and disclosure
requirements applicable to emerging growth companies could make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act, and, for as long as we continue to be an emerging growth company, we may
choose to take advantage of exemptions from various reporting requirements applicable to other public companies but not to emerging growth companies,
including:
•
•
•
not being required to have our independent registered public accounting firm audit our internal control over financial reporting under
Section 404 of the Sarbanes-Oxley Act;
reduced disclosure obligations regarding executive compensation in our periodic reports and annual report on Form 10-K; and
exemptions from the requirements of holding non-binding advisory votes on executive compensation and stockholder approval of any
golden parachute payments not previously approved.
We could be an emerging growth company for up to five years following the closing of our initial public offering of our common stock (our
“IPO”). Our status as an emerging growth company will end as soon as any of the following takes place:
•
•
•
•
the last day of the fiscal year in which we have more than $1.07 billion in annual revenue;
the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates;
the date on which we have issued, in any three-year period, more than $1.0 billion in non-convertible debt securities; or
December 31, 2024.
We cannot predict if investors will find our common stock less attractive if we choose to rely on any of the exemptions afforded emerging growth
companies. If some investors find our common stock less attractive because we rely on any of these exemptions, there may be a less active trading market
for our common stock and the market price of our common stock may be more volatile.
Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards
apply to private companies. We have irrevocably elected not to avail ourselves of this accommodation and, therefore, we will be subject to the same new or
revised accounting standards as other public companies that are not emerging growth companies.
Material weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results
or result in a material misstatement of our financial statements.
Management evaluates our internal control systems, processes, and procedures for compliance with the requirements of a smaller reporting
company under Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”). This evaluation includes disclosure of any material weaknesses identified
by our management in our internal control over financial reporting. A “material weakness” is a
55
deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material
misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In connection with preparation of our financial statements for the years ended December 31, 2017 and 2018, management identified a material
weakness in our internal controls due to a lack of sufficient full-time accounting staff with requisite experience and deep technical accounting knowledge to
(i) identify and resolve complex accounting issues under generally accepted accounting principles in the United States (“GAAP”) and (ii) allow for
appropriate segregation of duties. The identified material weakness could result in misstatements to our consolidated financial statements that would be
material and would not be prevented or detected on a timely basis.
We implemented additional procedures to remediate this material weakness, however, we cannot assure you that these or other measures will
prevent future material weaknesses from occurring. Remediation of the material weakness involved hiring a Chief Financial Officer in March 2019 and
four additional accounting resources in the second, third, and fourth quarters of 2019, including two Certified Public Accountants with the specific
technical accounting and financial reporting experience necessary for a public company. We will continue to assess the adequacy of our accounting
personnel and resources, and will add additional personnel, as well as adjust our resources, as necessary, commensurate with any increase in the size and
complexity of our business.
If we identify future material weaknesses in our internal controls over financial reporting or fail to meet the demands that are placed upon us as a
public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results or report them within
the timeframes required by law or stock exchange regulations. Failure to comply with Section 404 could also potentially subject us to sanctions or
investigations by the U.S. Securities and Exchange Commission (the “SEC”) or other regulatory authorities. If additional material weaknesses exist or are
discovered in the future, and we are unable to remediate any such material weakness, our reputation, financial condition, and operating results could suffer.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
We have implemented disclosure controls and procedures designed to provide reasonable assurance that information we must disclose in reports
we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized, and reported within
the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures, no matter how well-conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple
errors or mistakes. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an
unauthorized override of the controls. As a result, because of these inherent limitations in our control system, misstatements or omissions due to error or
fraud may occur and may not be detected, which could result in failures to file required reports in a timely manner and filing reports containing incorrect
information. Any of these outcomes could result in SEC enforcement actions, monetary fines or other penalties, damage to our reputation, and harm to our
financial condition.
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 2. Properties.
Our corporate headquarters are located in Menlo Park, California, and comprise approximately 31,280 square feet of space, pursuant to an
operating lease that expires in 2020. This lease includes an option to extend for an additional three years, at market rates that prevail at the time of our
election to extend. Our CLIA-certified laboratory is located in this facility.
We believe that this facility is sufficient to meet our current needs. We also believe we will be able to obtain additional space, as needed, on
commercially reasonable terms.
Item 3. Legal Proceedings.
From time to time, we are a party to litigation and subject to claims that arise in the ordinary course of business. Although the results of litigation
and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse
effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of
management resources and other factors. As of December 31, 2019, the Company was not involved in any material legal proceedings.
Item 4. Mine Safety Disclosures.
Not applicable.
56
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
The Company’s common stock has been listed on The Nasdaq Global Market under the symbol “PSNL” since June 20, 2019. Prior to our IPO,
PART II
there was no public market for our common stock.
Holders
As of March 20, 2020, there were approximately 144 holders of record of our common stock. The actual number of stockholders is greater than
this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other
nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividend Policy
We have not declared or paid any cash dividend on our common stock. We intend to retain any future earnings and do not expect to pay cash
dividends in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors and will depend on
then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other
factors our board of directors may deem relevant.
Recent Sales of Unregistered Securities
None.
Use of Proceeds from our Public Offering of Common Stock
On June 19, 2019, the registration statement on Form S-1 (Registration No. 333-231703) for our IPO of our common stock was declared
effective by the SEC. On June 24, 2019, we closed our IPO and sold an aggregate of 9,109,725 shares of our common stock, inclusive of the exercise in
full by the underwriters of their option to purchase up to an additional 1,188,225 shares of common stock, for an aggregate price of approximately $155
million. Upon completion of the sales of the shares of our common stock, our IPO terminated.
The underwriters of our IPO were Morgan Stanley & Co. LLC, BofA Securities, Inc., Cowen and Company, LLC, and Oppenheimer & Co. Inc.
We paid the underwriters of our IPO an underwriting discount and commission totaling $10.8 million and incurred $4.2 million in offering costs. Thus, the
net offering proceeds, after deducting underwriting discounts and offering expenses, were approximately $139.8 million. No payments were made to our
directors or officers or their associates, holders of 10% or more of any class of our equity securities, or any affiliates.
There has been no material change in the planned use of proceeds from our IPO as described in our final prospectus filed with the SEC on June
20, 2019 pursuant to Rule 424(b)(4).
Issuer Purchases of Equity Securities
During the quarter ended December 31, 2019, we did not purchase any of our equity securities that are registered under Section 12 of the
Exchange Act.
57
Item 6. Selected Financial Data.
The following selected consolidated financial data should be read in conjunction with the consolidated financial statements and the notes thereto
in Item 8 of Part II, “Financial Statements and Supplementary Data,” and the information contained in Item 7 of Part II, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations.” Historical results are not necessarily indicative of future results.
2019
Year Ended December 31,
2018
2017
Consolidated Statements of Operations:
Revenues
Costs and expenses
Costs of revenues
Research and development
Selling, general and administrative
Total costs and expenses
Loss from operations
Interest income
Interest expense
Loss on debt extinguishment
Other (expense) income, net
Loss before income taxes
Provision for income taxes
Net loss
Net loss per share, basic and diluted
Weighted-average shares outstanding, basic and diluted
Consolidated Balance Sheet Data:
Cash and cash equivalents, and short-term investments
Working capital
Total assets
Total debt
Long-term obligations
Total liabilities
Redeemable convertible preferred stock
Total stockholders' equity (deficit)
$
(in thousands, except share and per share data)
65,207 $
37,774 $
43,127
22,418
22,080
87,625
(22,418)
1,620
(1,133)
(1,704)
(1,440)
(25,075)
(9)
25,969
14,304
11,271
51,544
(13,770)
293
(1,894)
(4,658)
150
(19,879)
(7)
(25,084) $
(1.39) $
(19,886) $
(6.49) $
9,393
11,736
9,919
9,901
31,556
(22,163)
100
(1,303)
—
(227)
(23,593)
(5)
(23,598)
(7.78)
18,011,470
3,063,157
3,031,636
December 31,
2019
December 31,
2018
(in thousands)
December 31,
2017
128,289 $
89,616
157,291
—
639
50,601
—
106,690
19,744 $
(28,291)
41,670
4,996
804
58,654
89,404
(106,388)
22,617
(22,262)
33,563
17,506
1,183
50,171
75,995
(92,603)
$
$
$
58
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated
financial statements and the related notes and other financial information included elsewhere in this Annual Report on Form 10-K and our final prospectus
filed with the Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b) under the Securities Act of 1933, as amended, on June 20, 2019
(the “Prospectus”). In addition to historical consolidated financial information, the following discussion contains forward-looking statements that reflect
our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. You should review the
sections titled “Special Note Regarding Forward-Looking Statements” for a discussion of forward-looking statements and in Part I, Item 1A, “Risk
Factors” for a discussion of factors that could cause actual results to differ materially from the results described in or implied by the forward-looking
statements contained in the following discussion and analysis and elsewhere in this Annual Report on Form 10-K and in our Prospectus.
This section of this Form 10-K generally discusses 2019 and 2018 items and year-to-year comparisons between 2019 and 2018. Discussions of
2017 items and year-to-year comparisons between 2018 and 2017 that are not included in this Form 10-K can be found in “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our Prospectus.
Overview
We are a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive
molecular data about each patient’s cancer and immune response. We designed our NeXT Platform to adapt to the complex and evolving understanding of
cancer, providing our biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, in
contrast to many cancer panels that cover roughly 50 to 500 genes. In parallel with the development of our platform technology, we have also provided
population sequencing services under contract with the U.S. Department of Veterans Affairs (the “VA”) Million Veteran Program (the “VA MVP”), which
has enabled us to innovate, scale our operational infrastructure, and achieve greater efficiencies in our lab.
We are also developing a complementary liquid biopsy assay that analyzes all of the approximately 20,000 human genes versus the more
narrowly focused liquid biopsy assays that are currently available. By combining technological innovation, operational scale, and regulatory differentiation,
our NeXT Platform is designed to help our customers obtain new insights into the mechanisms of response and resistance to therapy as well as new
potential therapeutic targets. Our platform enhances the ability of biopharmaceutical companies to unlock the potential of conducting translational research
in the clinic rather than with pre-clinical animal models or cancer cell lines. We also announced in January 2020 a diagnostic based on our NeXT Platform
that we envision being used initially by both leading clinical cancer centers as well as biopharmaceutical companies.
We generated revenues of $65.2 million, $37.8 million, and $9.4 million for the years ended December 31, 2019, 2018, and 2017, respectively. In
2019, 67% of our revenues were generated from the U.S. Department of Veterans Affairs (the “VA”) Million Veteran Program (the “VA MVP”) as
compared to 49% in 2018. Non-VA MVP revenues increased by 13% in 2019 compared to 2018. We also incurred net losses of $25.1 million, $19.9
million and $23.6 million for the years ended December 31, 2019, 2018, and 2017, respectively.
As of December 31, 2019, we had $128.3 million in cash and cash equivalents, and short-term investments. From inception through December
31, 2019, we have funded our operations primarily through cash from operations, redeemable convertible preferred stock issuances, debt issuances, and
proceeds from our initial public offering. We expect that our existing cash and cash equivalents, and short-term investments will provide sufficient funds to
sustain operations through at least the next 12 months. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust
our available capital resources sooner than we expect.
Factors Affecting Our Performance
We believe there are several important factors that have impacted, and that we expect will continue to impact, our operating performance and
results of operations, including:
•
The continued development of the market for genomic-based tests. Our performance depends on the willingness of biopharmaceutical
customers to continue to seek more comprehensive molecular information to develop more efficacious cancer therapies.
59
•
•
•
•
•
Increasing adoption of our products and solutions by existing customers. Our performance depends on our ability to retain and broaden
adoption with existing customers. Because our technology is novel, some customers begin using our platform by initiating pilot studies
involving a small number of samples to gain experience with our service. As a result, historically a significant portion of our revenues has
come from existing customers. We believe that our ability to convert initial pilots into larger orders from existing customers has the
potential to drive substantial long-term revenue. We expect there may be some variation in the number of samples they choose to test each
quarter.
Adoption of our products and solutions by new customers. While new customers initially may not account for significant revenues, we
believe that they have the potential to grow substantially over the long term as they gain confidence in our service. Our ability to engage
new customers is critical to our long-term success. Our publications, posters and presentations at scientific conferences lead to engagement
at the scientific level with potential customers who often make the initial decision to gain experience with our platform. Accessing these
new customers through scientific engagement and marketing to gain initial buy-in is critical to our success and gives us the opportunity to
demonstrate the utility of our platform.
Our revenues and costs are affected by the volume of samples we receive from customers from period to period. The timing and size
of sample shipments received after orders have been placed is variable. Since sample shipments can be large, and are often received from a
third party, the timing of arrival can be difficult to predict over the short term. Although our long-term performance is not affected, we do
see quarter-to-quarter volatility due to these factors. Samples arriving later than expected may not be processed in the quarter proposed and
result in revenue the following quarter. Since many of our customers request defined turnaround times, we employ project managers to
coordinate and manage the complex process from sample receipt to sequencing and delivery of results.
Investment in product innovation to support commercial growth. Investment in research and development, including the development
of new products is critical to establish and maintain our leading position. In particular, we have invested in NeoantigenID, a neoantigen
characterization report, ImmunogenomicsID, a broad biomarker report, and ImmunoID NeXT, our universal cancer immunogenomics
platform. We are also collaborating with key opinion leaders from academic cancer centers, such as Inova Health System, Stanford
Medicine, and the Parker Institute for Cancer Immunotherapy, to support the utility of our platform. We believe this work is critical to
gaining customer adoption and expect our investments in these efforts to increase. We believe utility for our product may result in additional
expenditures to develop and market new products, including a diagnostic or database.
Leverage our operational infrastructure. We have invested significantly, and will continue to invest, in our sample processing capabilities
and commercial infrastructure. With our current operating model and infrastructure, we can increase our production and commercialize new
generations of our platform, but as our volumes continue to increase we will ultimately need to invest in additional production capabilities.
We expect to grow our revenues and spread our costs over a larger volume of services. In addition, we may invest significant amounts in
infrastructure to support new products resulting from our research and development activities.
In addition to the factors described above, as our headquarters and laboratory operations are located in San Mateo County, California, our
operations have been impacted by the ongoing COVID-19 pandemic. On March 16, 2020, the Health Officer of the County of San Mateo (the “Health
Officer”) issued a shelter-in-place order (the “San Mateo Order”), which directed all businesses to cease non-essential operations at physical locations in
the county. The San Mateo Order also directed all individuals living in the county to shelter at their place of residence with limited exceptions. The intent of
the San Mateo Order is to slow the spread of COVID-19 to the maximum extent possible. The San Mateo Order became effective on March 17, 2020 and
will continue to be in effect through April 7, 2020, or until it is extended, rescinded, superseded, or amended in writing by the Health Officer. Similar
orders were issued in neighboring counties, including Santa Clara County, such that the substantial majority of our employees are subject to a shelter-in-
place order. While the San Mateo Order allows for continued operation of so-called Essential Businesses, which includes certain critical healthcare
operations and services, to comply with the San Mateo Order, we are prioritizing the fulfillment of customer orders to those related to time-sensitive
healthcare projects, such as in-process clinical trials, and will fulfill other customer orders to the extent we have the ability to do so with limited laboratory
staffing. In addition, on March 19, 2020, the Governor of California and the State Public Health Officer and Director of the California Department of
Public Health ordered all individuals living in the State of California to stay at their place of residence for an indefinite period of time (subject to certain
exceptions to facilitate authorized necessary activities) to mitigate the impact of the COVID-19 pandemic (the “California Order” and, together with the
San Mateo Order, the “Orders”). Other states in the United States, including Massachusetts and New York, have followed suit by issuing orders with
similar goals and restrictions.
60
Beyond the immediate impact of the Orders to our operations, the ongoing COVID-19 pandemic, the Orders, and similar orders issued by other
authorities to impose restrictions intended to mitigate the impact of the COVID-19 pandemic, may disrupt our supply chain, including our ability to acquire
raw materials, disrupt customer demand, reduce our ability to receive customer samples on a normal basis, disrupt our customer and vendor relationships,
divert management attention, and negatively impact employee productivity due to work-from-home policies. The scope and duration of such impact is
highly uncertain. We are unable to predict or quantify the impact of any potential disruption to our supply chain, changes in consumer demand, or any other
actions that may become necessary as events unfold.
Components of Operating Results
Revenues
We derive our revenues primarily from sequencing and data analysis services to support the development of next-generation cancer therapies and
to support large scale genetic research programs. We support our customers by providing high-accuracy, validated genomic sequencing and advanced
analytics. Many of these analytics are related to state-of-the-art biomarkers, including those relevant to immuno-oncology therapeutics such as checkpoint
inhibitors.
Our revenues are primarily generated through contracts with companies in the pharmaceutical industry, healthcare organizations, and government
entities. Our ability to increase our revenues will depend on our ability to further penetrate this market. To do this, we are developing a growing set of
additional state-of-the-art products, advancing our operational infrastructure, building our regulatory credentials and expanding our targeted marketing
efforts. Unlike diagnostic or therapeutic companies, we have not to date sought reimbursement through traditional healthcare payors. We sell through a
small direct sales force.
We have one reportable segment from the sale of sequencing and data analysis services. Substantially all of our revenues to date have been
derived from sales in the United States.
Costs and Expenses
Costs of revenues
Costs of revenues consist of production material costs, personnel costs (salaries, bonuses, benefits, and stock-based compensation), costs of
consumables, laboratory supplies, depreciation and service maintenance on capitalized equipment, and information technology (“IT”) and facility costs. We
expect the costs of revenues to increase as our revenues grow, but the cost per unit of data delivered to decrease over time due to economies of scale we
may gain as volume increases, automation initiatives, and other cost reductions.
Research and development expenses
Research and development expenses consist of costs incurred for the development of our products. These expenses consist primarily of payroll
and personnel costs (salaries, bonuses, benefits, and stock-based compensation), costs of consumables, laboratory supplies, depreciation and service
maintenance on capitalized equipment, and IT and facility costs. These expenses also include costs associated with our collaborations, which we expect to
increase over time.
We expense our research and development expenses in the period in which they are incurred. We expect to increase our research and
development expenses as we continue to develop new products.
Selling, general, and administrative expenses
Selling expenses consist of personnel costs, customer support expenses, direct marketing expenses, educational and promotional expenses, and
market research. Our general and administrative expenses include costs for our executive, accounting, finance, legal, and human resources functions. These
expenses consist of personnel costs, audit and legal expenses, consulting costs, and IT and facility costs. We expense all selling, general, and administrative
expenses as incurred.
We expect our selling expenses will continue to increase in absolute dollars, primarily driven by our efforts to expand our commercial capability
and to expand our brand awareness and customer base through targeted marketing initiatives with an increased presence both within and outside the United
States. We also expect general and administrative expenses will increase as we scale our operations.
Interest Income
61
Interest income consists primarily of interest earned on our cash and cash equivalents, and short-term investments. Interest income increased
significantly in 2019 as a result of us investing proceeds from the IPO. We expect a continued higher level of interest income in 2020 for this reason.
Interest Expense
Interest expense primarily consists of cash and non-cash interest costs related to our term loan, convertible promissory notes, revolving loan, and
growth capital loan. We record costs incurred in connection with the issuance of debt as a direct deduction from the debt liability. We amortize these costs
over the term of our debt agreements as interest expense in our consolidated statements of operations. After the payoff of our growth capital loan in August
2019, we no longer have any outstanding debt and have not incurred interest expense from that point forward.
Loss on Debt Extinguishment
We incurred loss on debt extinguishment in 2018 resulting from changes in the maturity dates of the convertible notes issued in 2017. We also
incurred loss on debt extinguishment in 2019 upon the payoff of the growth capital loan. See Note 6 to our consolidated financial statements included
elsewhere in this annual report.
Other (Expense) Income, Net
Other (expense) income, net consists of changes in the fair value of the compound derivative instrument, changes in fair value of convertible
preferred stock warrant liability, and foreign currency exchange gains and losses. Future periods will not include changes in fair value of the compound
derivative instrument, due to extinguishment of the related convertible notes, nor will future periods include changes in fair value of convertible preferred
stock warrants, due to the conversion of such warrants to common stock warrants. See Notes 6 and 10 included elsewhere in this annual report for further
discussion of these two items. We expect our foreign currency gains and losses to continue to fluctuate in the future due to changes in foreign currency
exchange rates.
Results of Operations
The following table sets forth our consolidated statements of income data (in thousands):
Revenues
Costs and expenses
Costs of revenues
Research and development
Selling, general and administrative
Total costs and expenses
Loss from operations
Interest income
Interest expense
Loss on debt extinguishment
Other (expense) income, net
Loss before income taxes
Provision for income taxes
Net loss
Net loss per share, basic and diluted
2019
Year Ended December 31,
2018
2017
$
65,207 $
37,774 $
9,393
43,127
22,418
22,080
87,625
(22,418)
1,620
(1,133)
(1,704)
(1,440)
(25,075)
(9)
25,969
14,304
11,271
51,544
(13,770)
293
(1,894)
(4,658)
150
(19,879)
(7)
$
$
(25,084) $
(1.39) $
(19,886) $
(6.49) $
11,736
9,919
9,901
31,556
(22,163)
100
(1,303)
—
(227)
(23,593)
(5)
(23,598)
(7.78)
Weighted-average shares outstanding, basic and diluted
18,011,470
3,063,157
3,031,636
Revenues
The following table shows revenues by customer type (in thousands):
VA MVP
All other customers
Total revenues
Year Ended December 31,
Percentage change
2019
2018
2017
2019 vs 2018
2018 vs 2017
$
$
43,545 $
21,662
65,207 $
18,601 $
19,173
37,774 $
421
8,972
9,393
134%
13%
73%
4,318%
114%
302%
62
The following table shows our concentration of revenues by customer:
VA MVP
Pfizer Inc.
Merck & Co., Inc.
Customer A
Customer B
* Less than 10% of revenues
VA MVP
2019
Year Ended December 31,
2018
2017
67%
13%
*
*
*
49%
10%
12%
*
*
*
*
11%
13%
10%
The increase in 2019 revenues from the VA MVP was driven by an increase in the volume of samples we tested in the period, partially offset by
lower prices per sample.
All Other Customers
The increase in 2019 revenues from all other customers was primarily due to an increase in the volume of samples we tested in relation to the
sequencing and data analysis services we provided to our customers.
Costs and Expenses
Costs of revenues
Research and development
Selling, general and administrative
Total costs and expenses
Costs of revenues
Year Ended December 31,
2019
2018
(in thousands)
Percentage change
2017
2019 vs 2018
2018 vs 2017
$
$
43,127 $
22,418
22,080
87,625 $
25,969 $
14,304
11,271
51,544 $
11,736
9,919
9,901
31,556
66%
57%
96%
70%
121%
44%
14%
63%
The increase in 2019 was primarily due to the increase in revenues discussed above. The cost components related to the increase in costs of
revenues were an $11.7 million increase in production materials, a $2.2 million increase related to personnel costs including salaries, bonuses, benefits, and
stock-based compensation expenses, a $1.6 million increase in depreciation and service maintenance on capitalized equipment, a $0.5 million increase in
the consumption cost of consumables and laboratory supplies, a $0.9 million increase in IT and facility costs, and a $0.3 million increase in other costs.
Research and development
The increase in 2019 was primarily due to increased development activities for new product offerings, lab and automation development costs,
and IT and facility costs. Research and development expenses increased due to an increase of $4.0 million in personnel-related expenses, including salaries,
bonuses, benefits, and stock-based compensation expenses, a $2.8 million increase in laboratory and automation supplies consumed, a $1.2 million increase
in depreciation, service maintenance on capitalized equipment, and cost of expensed equipment, and $0.2 million increase in other costs.
Selling, general and administrative
The increase in 2019 was due to a $7.3 million increase in personnel-related expenses including salaries, bonuses, benefits, and stock-based
compensation expenses primarily related to increased headcount, a $3.0 million increase in professional services primarily related to public company-
related costs (including corporate insurance, audit fees, and legal expenses), and a $0.5 million increase in other costs.
63
Interest income, interest expense, and loss on debt extinguishment
Interest income
Interest expense
Loss on debt extinguishment
Year Ended December 31,
2019
2018
(in thousands)
Percentage change
2017
2019 vs 2018
2018 vs 2017
$
$
1,620
(1,133)
(1,704)
$
293
(1,894)
(4,658)
100
(1,303)
—
453%
(40)%
(63)%
193%
45%
NM
Total interest income, interest expense and loss on debt
extinguishment
$
(1,217) $
(6,259) $
(1,203)
Interest income
The increase in 2019 was due to investments of proceeds from our IPO.
Interest expense
The lower interest expense in 2019 was due to the repayment of the $20 million growth capital loan in August 2019, which resulted in no further
outstanding debt for the remainder of the year, as well as 2018 including significant interest expense from the Convertible Notes and Revolving Loan.
Loss on debt extinguishment
The $1.7 million loss on debt extinguishment in 2019 resulted from the extinguishment of our $20 million Growth Capital Loan facility. The
$4.7 million loss on debt extinguishment in 2018 resulted from changes in the maturity dates of the Convertible Notes issues in 2017.
Other (expense) income, net
Changes in fair values of warrants for Series B and Series C
convertible preferred stock
Changes in fair value of the compound derivative instrument
Other
Total other (expenses) income, net
Year Ended December 31,
2019
2018
2017
(in thousands)
Change $
2019 vs 2018
2018 vs 2017
$
$
(1,403) $
—
(37)
(1,440) $
(391) $
574
(33)
150 $
(64) $
(162)
(1)
(227) $
(1,012) $
(574)
(4)
(1,590) $
(327)
736
(32)
377
Other expenses, net in 2019 were primarily comprised of a $1.4 million increase in the fair values of warrants for Series B and Series C
redeemable convertible preferred stock. Other income, net in 2018 was primarily comprised of a $0.6 million decrease in fair value of the compound
derivative instrument, partially offset by a $0.4 million increase in the fair values of warrants for Series B and Series C redeemable convertible preferred
stock.
Liquidity and Capital Resources
The following table presents selected financial information and statistics as of and for the years ended December 31, 2019, 2018, and 2017 (in
thousands):
Cash and cash equivalents, and short-term investments
Property and equipment, net
Contract liabilities
Total debt
Working capital
Cash (used in) provided by operating activities
Cash used in investing activities
Cash provided by (used in) financing activities
$
2019
Year Ended December 31,
2018
(in thousands)
2017
128,289 $
14,106
35,977
—
89,616
(18,069)
(81,579)
134,948
19,744 $
11,452
42,897
4,996
(28,291)
5,572
(7,852)
(591)
22,617
6,342
24,690
17,506
(22,262)
290
(5,158)
16,404
64
From our inception through December 31, 2019, we have funded our operations primarily from $144.0 million in net proceeds from our initial
public offering in June 2019 and $89.6 million from issuance of redeemable convertible preferred stock, as well as cash from operations and debt financing.
On March 22, 2019, we received $20.0 million in gross cash proceeds from a growth capital loan. As of December 31, 2019, we had cash and cash
equivalents in the amount of $55.0 million.
We have incurred net losses since our inception. We anticipate that our current cash and cash equivalents and marketable securities, together with
cash provided by operating activities are sufficient to fund our near-term capital and operating needs for at least the next 12 months.
We have based these future funding requirements on assumptions that may prove to be wrong, and we could utilize our available capital
resources sooner than we expect. If our available cash balances, net proceeds from the offering and anticipated cash flow from operations are insufficient to
satisfy our liquidity requirements including because of lower demand for our services or other risks described in this annual report, we may seek to sell
additional common or preferred equity or convertible debt securities, enter into an additional credit facility or another form of third-party funding or seek
other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity
securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt
securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. Additional capital may not be
available on reasonable terms, or at all.
On March 22, 2019, we entered into a growth capital loan (the “Growth Capital Loan”) with TriplePoint to provide for a $20.0 million growth
capital loan facility and as of June 30, 2019, had drawn down the full $20.0 million available under the facility. We used $5.1 million of the Growth Capital
Loan to repay, in its entirety, all amounts outstanding under the Revolving Loan. Borrowings under the Growth Capital Loan bore interest at a floating rate
of prime, plus 5.00%, for borrowings up to $15.0 million and the prime rate plus 6.50% for borrowings greater than $15.0 million. Under the agreement,
we were required to make monthly interest-only payments through April 1, 2020 and required to make 36 equal monthly payments of principal, plus
accrued interest, from April 1, 2020 through March 1, 2023, when all unpaid principal and interest was to become due and payable. The agreement allowed
voluntary prepayment of all, but not part, of the outstanding principal at any time prior to the maturity date, subject to a prepayment fee of 1.00% of the
outstanding balance if prepaid in months one through 12 of the loan term. In addition to the final payment, we paid an amount equal to 2.75% of each
principal amount drawn under this growth capital loan facility.
In connection with the Growth Capital Loan, we issued a warrant to purchase 65,502 shares of common stock to TriplePoint at an exercise price
of $9.16 per share exercisable for seven years from March 22, 2019. We recorded the issuance-date fair value of the warrant of $0.6 million and fees paid to
TriplePoint of $0.3 million as a debt discount, which was amortized over the term of the Growth Capital Loan using the effective interest method. Upon
issuance, the Growth Capital Loan had an effective interest rate of 15.23% per year. Interest expense for the year ended December 31, 2019 was $1.0
million.
On August 14, 2019, we paid off the Growth Capital Loan in its entirety and recorded a $1.7 million loss on extinguishment of debt in the
consolidated statements of operations.
Our short-term investments portfolio is primarily invested in highly rated securities, with the primary objective of minimizing the potential risk
of principal loss. Our investment policy generally requires securities to be investment grade and limits the amount of credit exposure to any one issuer.
During 2019, cash used by operating activities of $18.1 million was a result of $25.1 million of net loss and the net negative change in operating
assets and liabilities of $7.3 million, partially offset by non-cash negative adjustments to net income of $14.3 million.
Cash used by investing activities of $81.6 million during 2019 consisted of purchases of available-for-sale debt securities, net of maturities and
sales, of $73.2 million, and cash used to acquire property and equipment of $8.4 million.
Cash provided by financing activities of $134.9 million during 2019 consisted primarily of $139.8 million of proceeds from initial public
offering, net of underwriting discounts and commissions, $1.4 million of proceeds from issuance of common stock under employee stock plans, and net
proceeds from the issuance of a Growth Capital Loan of $20.0 million, partially offset by cash used to repay a revolving loan and issue and repay the
Growth Capital Loan of $26.3 million.
65
Investments in property and equipment
The Company’s capital expenditures were $8.4 million during 2019, which was primarily related to the acquisition of property and equipment
used for our sequencing and data analysis services.
Debt
We previously entered into various forms of convertible debt and revolving loans to finance our operations prior to our IPO. After our IPO, we
paid off all remaining debt and now have zero outstanding debt balances as of 2019.
Further information regarding the Company’s debt issuances can be found in Part II, Item 8 of this Form 10-K in the Notes to Consolidated
Financial Statements in Note 6, “Borrowings.”
Contractual Obligations
As a “smaller reporting company”, we are not required to provide this disclosure.
Off-balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of December 31, 2019.
Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, costs and expenses, and related disclosures.
Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions or conditions.
An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly
uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably possible
could materially impact the financial statements. We believe that the assumptions and estimates associated with the accounting policies discussed below
have the greatest potential impact on our consolidated financial statements. Therefore, we consider these to be our critical accounting policies and
estimates.
Revenue Recognition
Adoption of ASC Topic 606, “Revenue from Contracts with Customers”
On January 1, 2017, we early adopted the new accounting standard ASC Topic 606 using the full retrospective method. Results for reporting
periods beginning after January 1, 2017, are presented under ASC Topic 606. The impact of adopting ASC Topic 606 was not material on our consolidated
financial statements.
Revenue Recognition
We generate our revenues from selling sequencing and data analysis services. We agree to provide services to our customers through a contract,
which may be in the form of a combination of a signed agreement, statement of work and/or a purchase order.
Upon adoption of ASC Topic 606, we have evaluated the performance obligations contained in contracts with customers to determine whether
any of the performance obligations are distinct, such that the customers can benefit from the obligations on their own, and whether the obligations can be
separately identifiable from other obligations in the contract. For all of our contracts to date, the customer orders a specified quantity of a sequencing;
therefore, the delivery of the ordered quantity per the purchase order is accounted for as one performance obligation. Our contracts include only one
performance obligation—the delivery of the sequencing and data analysis services to the customer.
Fees for our sequencing and data analysis services are predominantly based on a fixed price per sample. The fixed prices identified in the
arrangements only change if a pricing amendment is agreed with a customer. In limited cases we provide our customers a discount if samples received are
above a certain volume are purchased. In such cases, the discount applies prospectively. We have analyzed such discounts if they represent a material right
provided to a customer. We have concluded that such discounts do not represent a material right provided to a customer since they are not deemed to be
incremental to the pricing offered to the customer, or are not enforceable options to acquire additional goods. As a result, these discounts do not constitute a
material right and do not meet the definition of a separate performance obligation. We do not offer retrospective discounts or rebates. Accordingly, all of
66
the transaction price, net of any discounts, is allocated to one performance obligation. Therefore, upon delivery of the services, there are no remaining
performance obligations.
Contracts that contain multiple distinct performance obligations would require an allocation of the transaction price to each performance
obligation based on a relative stand-alone selling price basis. Sometimes we deliver sequencing results in two or more batches; however, since the quantity
delivered per batch of each individual test per sales order in these instances is in the same ratio as in the original sales order, allocating the transaction price
on a relative stand-alone selling price basis would have no impact on the revenue recognized in any period presented.
We recognize revenue when control of the promised services is transferred to our customers. Management applies judgment in evaluating when a
customer obtains control of the promised service, which is when the sequencing and data analysis service results are delivered to customers, at an amount
that reflects the consideration to which we expect to be entitled to in exchange for those services. Revenue is recorded net of sales or other transaction taxes
collected from clients and remitted to taxing authorities.
A customer contract liability will arise when we have received payments from its customers in advance, but has not yet provided genome and
exome sequencing and data analysis services to a customer and satisfied its performance obligations. We record a customer contract liability for
performance obligations outstanding related to payments received in advance for customer deposits. We expect to satisfy these remaining performance
obligations and recognize the related revenues upon providing sequencing and data analysis services.
All of our revenues and trade receivables are generated from contracts with customers and substantially all of our revenues are derived from U.S.
domestic operations. The following section describes the accounting policies that we believe have significant judgment, or changes in judgment, as a result
of adopting ASC Topic 606.
Payment Terms
Payment terms and conditions vary by contract and customer. Our standard payment terms are typically less than 90 days from the date of
invoice. In instances where the timing of our revenue recognition differs from the timing of its invoicing, we have determined that our contracts do not
include a significant financing component. The primary purposes of our invoicing terms are to provide customers with simplified and predictable ways of
purchasing our services and provide payment protection for us.
Convertible Preferred Stock Warrants
We accounted for warrants to purchase shares of our redeemable convertible preferred stock as liabilities at their estimated fair value because the
warrants may have obligated us to transfer assets to the holders at a future date upon a deemed liquidation event. The warrants were recorded at fair value
upon issuance and were subject to remeasurement to fair value at each period end, with any fair value adjustments recognized in the consolidated
statements of operations and comprehensive loss. We adjusted the warrant liability for changes in fair value until the conversion of redeemable convertible
preferred stock into common stock.
Common Stock Warrants
Our common stock warrants are classified as equity as they meet all criteria for equity classification. The common stock warrants were recorded
at fair value upon issuance, or conversion to common stock warrants in the case of our convertible preferred stock warrants, as additional paid-in-capital in
the consolidated balance sheets. The common stock warrants are not subsequently remeasured.
Convertible Instruments
We evaluate and account for conversion options embedded in convertible instruments in accordance with ASC Topic 815, Derivatives and
Hedging Activities. Applicable GAAP requires companies to bifurcate conversion options from their host instruments and account for them as freestanding
derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the
embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument
that embodies both the embedded derivative instrument and the host contract is not remeasured at fair value under other GAAP with changes in fair value
reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a
derivative instrument.
Stock-Based Compensation
We account for stock-based compensation arrangements with employees, using a fair value-based method, for costs related to all stock-based
payments including stock options and stock awards. Our determination of the fair value of stock options on the date of grant utilizes the Black-Scholes
option-pricing model.
67
The fair value of the option granted is recognized over the period during which an optionee is required to provide services in exchange for the
option award, known as the requisite service period which usually is the vesting period, on a straight-line basis.
Estimating the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option-pricing model, is
affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value and ultimately how much
stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.
•
•
•
•
Expected Term—The expected term assumption represents the weighted-average period that the stock-based awards are expected to be
outstanding. We have elected to use the “simplified method” for estimating the expected term of the options, whereby the expected term
equals the arithmetic average of the vesting term and the original contractual term of the option.
Expected Volatility—For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer
companies. For purposes of identifying these peer companies, we considered the industry, stage of development, size, and financial leverage
of potential comparable companies.
Expected Dividend Yield—The Black-Scholes option-pricing valuation model calls for a single expected dividend yield as an input. We
currently have no history or expectation of paying cash dividends on our common stock.
Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to
the expected term of the equity-settled award.
We estimated the fair value of the time-based employee stock options using the Black-Scholes option-pricing model based on the date of grant
with the following assumptions:
Common Stock Valuations
The estimated fair value of the common stock underlying our stock options was determined at each grant date by our board of directors, with
input from management. All options to purchase shares of our common stock are intended to be exercisable at a price per share not less than the per-share
fair value of our common stock underlying those options on the date of grant.
In the absence of a public trading market for our common stock prior to our IPO, on each grant date, we developed an estimate of the fair value
of our common stock based on the information known to us on the date of grant, upon a review of any recent events and their potential impact on the
estimated fair value per share of the common stock, and in part on input from an independent third-party valuation firm. As provided in Section 409A of
the U.S. Internal Revenue Code of 1986, as amended (the “Code”), we generally relied on our valuations for up to 12 months unless we experienced a
material event that would have affected the estimated fair value per common share.
Our valuations of our common stock were determined in accordance with the guidelines outlined in the American Institute of Certified Public
Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). The methodology to
determine the fair value of our common stock included estimating the fair value of the enterprise using the “backsolve” method, which estimates the fair
value of our company by reference to the value and preferences of our last round of financing, as well as our capitalization.
The assumptions used to determine the estimated fair value of our common stock were based on numerous objective and subjective factors,
combined with management’s judgment, including external market conditions affecting the pharmaceutical and biotechnology industry and trends within
the industry:
•
•
•
•
•
•
•
our stage of development;
the rights, preferences, and privileges of our redeemable convertible preferred stock relative to those of our common stock;
the prices at which we sold shares of our redeemable convertible preferred stock;
our financial condition and operating results, including our levels of available capital resources;
the progress of our research and development efforts, our stage of development, and business strategy;
equity market conditions affecting comparable public companies; and
general U.S. market conditions and the lack of marketability of our common stock.
68
The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the
estimated fair value of common stock at each valuation date. In accordance with the Practice Aid, we considered the following methods:
•
•
•
Income approach. The income approach attempts to value an asset or security by estimating the present value of the future economic
benefits it is expected to produce. These benefits can include earnings, cost savings, tax deductions, and disposition proceeds from the asset.
An indication of value may be developed in this approach by discounting expected cash flows to their present value at a rate of return that
incorporates the risk-free rate for the use of funds, the expected rate of inflation over the asset’s holding period, and the risks associated with
realizing the cash flows in the amounts and at the times projected. The discount rate selected is typically based on rates of return available
from alternative investments of similar type and quality as of the valuation date. The most commonly employed income approach to
valuation is the discounted cash flow analysis.
Market Approach. The market approach attempts to value an asset or security by examining observable market values for similar assets or
securities. Sales and offering prices for comparable assets are adjusted to reflect differences between the asset being valued and the
comparable assets, such as, location, time and terms of sale, utility, and physical characteristics. When applied to the valuation of equity, the
analysis may include consideration of the financial condition and operating performance of the company being valued relative to those of
publicly traded companies or to those of companies acquired in a single transaction, which operate in the same or similar lines of business.
Cost Approach. The cost approach to valuation is based upon the concept of replacement cost as an indicator of value and the notion that an
investor would pay no more for an asset than what it would cost to replace the asset with one of equal utility. The cost approach estimates
value based upon the estimated cost of replacing or reproducing the asset, less adjustments for physical deterioration and functional
obsolescence, if relevant. When applied to an enterprise, a type of cost approach referred to as the Net Asset Method is sometimes
employed. This method measures the value of equity as the sum of the values of its assets reduced by the sum of the values of its liabilities.
The resulting equity is reflective of a 100% ownership interest in the business. This approach is frequently used in valuing holding
companies.
Based on our early stage of development and other relevant factors, we considered all three approaches and chose to apply both income and
market approaches in our analyses. We determined these approaches were the most appropriate methods for allocating our enterprise value to determine the
estimated fair value of our common stock for valuations performed for periods up to our IPO. In determining the estimated fair value of our common stock,
our board of directors also considered the fact that our stockholders could not freely trade our common stock in the public markets. Accordingly, we
applied discounts to reflect the lack of marketability of our common stock based on the weighted-average expected time to liquidity. The estimated fair
value of our common stock at each grant date reflected a non-marketability discount partially based on the anticipated likelihood and timing of a future
liquidity event.
Following our IPO, our board of directors determines the fair value of our common stock based on the closing quoted market price of our
common stock on the date of grant.
Income Taxes
We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between
the financial statement reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards and are measured using the enacted
tax rates and laws that will be in effect when such items are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation
allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized.
We assess all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject
to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s
sustainability and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.
We have elected to account for the tax on Global Intangible Low-Taxed Income, enacted as part of the Tax Cuts and Jobs Act as a component of
tax expense in the period in which the tax is incurred.
JOBS Act Accounting Election
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Under the JOBS Act, emerging
growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those
standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards, and
therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
69
Recent Accounting Pronouncements
See the sections titled “Summary of Significant Accounting Policies—Recent Accounting Pronouncements” and “—Recent Accounting
Pronouncements Not Yet Adopted” in Note 2 to our consolidated financial statements for additional information.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
As a “smaller reporting company”, we are not required to provide the information under this item.
70
Item 8. Financial Statements and Supplementary Data.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
71
Page
72
73
74
75
76
77
98
PERSONALIS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
2019
December 31,
2018
Assets
Current assets
Cash and cash equivalents
Short-term investments
Accounts receivable, net
Inventory and other deferred costs
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Operating lease right-of-use assets
Other long-term assets
Total assets
Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities
Accounts payable
Accrued and other current liabilities
Contract liabilities
Short-term debt
Total current liabilities
Redeemable convertible preferred stock warrant liability
Other long-term liabilities
Total liabilities
Commitments and Contingencies (Note 12)
Redeemable convertible preferred stock
Stockholders’ equity (deficit)
$
$
$
Common stock, $0.0001 par value — 200,000,000 shares authorized and 31,243,029 shares
issued and outstanding as of December 31, 2019; 102,700,000 shares authorized and 3,085,307
shares issued and outstanding as of December 31, 2018
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders’ equity (deficit)
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)
$
See accompanying notes to consolidated financial statements.
72
55,046 $
73,243
3,300
4,606
3,383
139,578
14,106
1,845
1,762
157,291 $
7,337 $
6,648
35,977
—
49,962
—
639
50,601
—
3
247,282
(6)
(140,589)
106,690
157,291 $
19,744
—
4,457
3,432
1,926
29,559
11,452
—
659
41,670
6,565
3,392
42,897
4,996
57,850
683
121
58,654
89,404
1
9,131
(15)
(115,505)
(106,388)
41,670
PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Revenues
Costs and expenses
Costs of revenues
Research and development
Selling, general and administrative
Total costs and expenses
Loss from operations
Interest income
Interest expense
Loss on debt extinguishment
Other (expense) income, net
Loss before income taxes
Provision for income taxes
Net loss
Net loss per share, basic and diluted
2019
Year Ended December 31,
2018
2017
$
65,207 $
37,774 $
9,393
43,127
22,418
22,080
87,625
(22,418)
1,620
(1,133)
(1,704)
(1,440)
(25,075)
(9)
25,969
14,304
11,271
51,544
(13,770)
293
(1,894)
(4,658)
150
(19,879)
(7)
$
$
(25,084) $
(1.39) $
(19,886) $
(6.49) $
11,736
9,919
9,901
31,556
(22,163)
100
(1,303)
—
(227)
(23,593)
(5)
(23,598)
(7.78)
Weighted-average shares outstanding, basic and diluted
18,011,470
3,063,157
3,031,636
See accompanying notes to consolidated financial statements.
73
PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss
Other comprehensive income (loss), net of tax
Foreign currency translation adjustment
Change in unrealized gain on available-for-sale debt securities
Comprehensive loss
2019
Year Ended December 31,
2018
2017
$
(25,084) $
(19,886) $
(23,598)
3
6
(5)
—
$
(25,075) $
(19,891) $
7
—
(23,591)
See accompanying notes to consolidated financial statements.
74
PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share data)
Balance—December 31, 2016
16,806,745 $ 75,995 3,020,842 $
1 $
2,196 $
Redeemable
Convertible
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive
Loss
Accumulated
Deficit
(17) $ (72,021) $
Total
Stockholders'
Equity
(Deficit)
(69,841)
Proceeds from exercise of stock
options
Stock-based compensation
Foreign currency translation
adjustment
Net loss
Balance—December 31, 2017
Equity component credited to
additional paid-in capital upon
Convertible Notes modification
on May 31, 2018 and August 20,
2018 (see Note 6)
Convertible Notes conversion on
September 20, 2018 (see Note 6);
including issuance of Series C
redeemable convertible preferred
stock
Proceeds from exercise of stock
options
Stock-based compensation
Foreign currency translation
adjustment
Net loss
Balance—December 31, 2018
Issuance of common stock
warrants
Elimination of fractional shares
upon reverse stock split (see
Notes 2 and 8)
Exercise of common stock
warrants
Conversion of Series A, B and C
redeemable convertible preferred
stock to common stock
Conversion of redeemable
convertible preferred stock
warrants to common stock
warrants
Proceeds from initial public
offering, net of expenses
Proceeds from exercise of stock
options
Proceeds from ESPP purchase
Stock-based compensation
Foreign currency translation
adjustment
Unrealized gain on available-for-
sale debt securities
Net loss
Balance—December 31, 2019
—
—
—
—
30,625
—
—
—
16,806,745 75,995 3,051,467
—
—
—
—
—
—
—
—
1
76
753
—
—
3,025
—
—
—
—
76
753
7
—
(10)
—
(23,598)
(95,619)
7
(23,598)
(92,603)
—
—
—
—
4,690
—
—
4,690
1,667,997 13,409
—
—
—
—
—
—
—
—
—
—
33,840
—
—
—
99
1,317
—
—
—
—
99
1,317
—
—
18,474,742 89,404 3,085,307
—
—
—
—
—
—
1
—
—
9,131
(5)
—
(15)
—
(19,886)
(115,505)
(5)
(19,886)
(106,388)
—
—
—
—
572
—
—
572
(39)
—
(34)
(1)
—
—
207,712
—
1
8
—
—
—
—
—
8
(18,474,703) (89,404) 18,474,703
2 89,402
—
—
89,404
—
—
—
—
2,086
—
—
2,086
—
— 9,109,725
1 139,827
—
—
139,828
—
—
—
—
—
—
287,932
77,684
—
—
—
—
713
684
4,858
—
—
—
—
713
684
4,858
—
—
—
—
—
3
—
3
—
—
— $
—
—
—
—
— 31,243,029 $
See accompanying notes to consolidated financial statements.
—
—
3 $ 247,282 $
—
—
—
(25,084)
6
6
—
(25,084)
(6) $ (140,589) $ 106,690
75
PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
2019
Year Ended December 31,
2018
2017
$
(25,084) $
(19,886) $
(23,598)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash (used in) provided by operating activities
Depreciation and amortization
Noncash operating lease cost
Stock-based compensation expense
Loss on debt extinguishment
Change in fair value of convertible preferred stock warrant liability
Change in fair value of compound derivative instrument
Accretion of noncash interest and debt reduction
Other
Changes in operating assets and liabilities
Accounts receivable
Inventories and other deferred costs
Prepaid expenses and other assets
Accounts payable
Accrued and other current liabilities
Contract liabilities
Other long-term liabilities
Net cash (used in) provided by operating activities
Cash flows from investing activities:
Purchase of available-for-sale debt securities
Proceeds from maturities of available-for-sale debt securities
Purchase of property and equipment
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from initial public offering, net of underwriting discounts and commissions
Payment of costs related to initial public offering
Proceeds from borrowings
Payments of borrowing costs
Repayments under borrowing arrangements
Debt extinguishment costs
Proceeds from issuance of common stock under ESPP
Proceeds from exercise of stock options
Other
Net cash provided by (used in) financing activities
Effect of exchange rates on cash flows and cash equivalents
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning of period
Cash and cash equivalents, end of period
Supplemental disclosures of cash flow information:
Cash paid for interest
Income taxes paid
Supplemental disclosures of noncash investing and financing activities:
Acquisition of property and equipment included in accounts payable and accrued
liabilities
Convertible Notes conversion on September 20, 2018 (see Note 6)
$
$
$
$
$
4,748
982
4,858
1,704
1,403
—
156
427
1,069
(1,174)
(2,559)
1,398
1,999
(6,920)
(1,076)
(18,069)
(78,897)
5,700
(8,382)
(81,579)
144,025
(4,197)
20,000
(490)
(25,000)
(794)
684
712
8
134,948
2
35,302
19,744
55,046 $
1,257 $
6 $
3,066
—
1,317
4,658
391
(574)
1,188
(5)
(2,519)
(2,068)
(1,265)
2,164
997
18,207
(99)
5,572
—
—
(7,852)
(7,852)
—
—
—
—
(645)
—
—
76
(22)
(591)
(2)
(2,873)
22,617
19,744 $
698 $
7 $
41 $
- $
323 $
13,431 $
1,216
—
753
—
64
162
928
6
(1,203)
(539)
177
2,635
684
19,072
(67)
290
—
—
(5,158)
(5,158)
—
—
17,225
(63)
(823)
—
—
65
—
16,404
4
11,540
11,077
22,617
321
5
521
-
See accompanying notes to consolidated financial statements.
76
PERSONALIS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Company and Nature of Business
Description of Business
Personalis, Inc. (the “Company”) was incorporated in Delaware on February 21, 2011 and began operations in September 2011. The Company
formed a wholly owned subsidiary, Personalis (UK) Ltd., in August 2013. The Company is a growing cancer genomics company transforming the
development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. The
Company operates and manages its business as one reportable operating segment, which is the sale of sequencing and data analysis services.
Significant Risks and Uncertainties
The Company has incurred net operating losses each year since inception. As of December 31, 2019, the Company had an accumulated deficit of
$140.6 million.
In June 2019, the Company completed an initial public offering (“IPO”) of its common stock and raised proceeds of $139.8 million, after
deducting underwriting discounts, commissions and offering expenses. Management believes that these proceeds combined with existing sources of
liquidity will be sufficient to fund operations for at least one year from the issuance of these consolidated financial statements. However, there can be no
assurance that additional financing will not be required or that the Company will be successful in raising additional capital on terms that are acceptable to
the Company.
If the Company requires but is unable to obtain additional funding, the Company could be required to modify, delay, or abandon some of its
planned future expansion or expenditures or reduce some of its ongoing operating costs, which could harm its business, operating results, financial
condition, and ability to achieve its intended business objectives.
Approval of Amended and Restated Certificate of Incorporation
An amended and restated certificate of incorporation, which authorized 200,000,000 shares of common stock and 10,000,000 shares of preferred
stock, became effective in June 2019 in connection with the closing of the Company’s IPO. As of December 31, 2019 no shares of preferred stock are
outstanding.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of
America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding annual reporting. The
consolidated financial statements include the accounts of Personalis, Inc. and its wholly owned subsidiary, Personalis (UK) Ltd. All intercompany balances
and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the consolidated financial
statements and the reported amounts of revenues and expenses during the reporting period. The estimates include, but are not limited to, useful lives
assigned to long-lived assets, the valuation of common and convertible redeemable preferred stock and related warrants and options, the valuation of the
compound derivative instrument, the valuation of stock-based awards, and provisions for income taxes and contingencies. Actual results could differ from
these estimates, and such differences could be material to the Company’s consolidated financial position and results of operations.
Reverse Stock Split
On June 4, 2019, the Company filed an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse split of
shares of the Company’s common stock and redeemable convertible preferred stock on a four-for-one basis (the “Reverse Stock Split”). The par value of
the common stock and redeemable convertible preferred stock was not adjusted as a result of the Reverse Stock Split. All references to common stock,
options to purchase common stock, share data, per share data, redeemable convertible preferred stock and related information contained in these
consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented.
77
Initial Public Offering
On June 20, 2019, the Company completed an IPO in which it issued and sold 9,109,725 shares of its common stock at a public offering price of
$17.00 per share. The Company received net proceeds of $139.8 million after deducting underwriting discounts, commissions and offering expenses.
Offering expenses were $4.2 million and consisted of fees and expenses incurred in connection with the sale of the Company’s common stock in the IPO,
including legal, accounting, printing, and other IPO-related costs, all of which were paid by December 31, 2019.
A warrant to purchase 188,643 shares of our common stock was exercised prior to completion of the IPO. In addition, in connection with the
IPO, all shares of the Company’s then-outstanding redeemable convertible preferred stock were automatically converted into 18,474,703 shares of the
Company’s common stock, and all then-outstanding warrants to purchase the Company’s convertible preferred stock were automatically converted into
warrants to purchase 84,585 shares of the Company’s common stock, of which 62,096 are still outstanding as of December 31, 2019 (see Note 10).
Concentration of Credit Risk and Other Risks and Uncertainties
The Company is subject to credit risk from its portfolio of cash and cash equivalents. The Company’s cash and cash equivalents are deposited
with high-quality financial institutions. Deposits at these institutions may, at times, exceed federally insured limits. Management believes these financial
institutions are financially sound and, accordingly, that minimal credit risk exists. The Company has not experienced any losses on its deposits of cash and
cash equivalents.
The Company also invests in investment‑grade debt instruments and has policy limits for the amount it can invest in any one type of security,
except for securities issued or guaranteed by the U.S. government. The goals of the Company’s investment policy are as follows: preservation of principal;
liquidity of investments sufficient to meet cash flow requirements; avoidance of inappropriate concentration and credit risk; competitive after‑tax rate of
returns; and fiduciary control of cash and investments. Under its investment policy, the Company limits the amounts invested in such securities by credit
rating, maturity, investment type, and issuer. As a result, management believes that these financial instruments do not expose the Company to any
significant concentrations of credit risk.
The Company purchases various reagents and sequencing materials from sole source suppliers. Any extended interruption in the supply of these
materials could result in the Company’s inability to secure sufficient materials to conduct business and meet customer demand.
The Company routinely assesses the creditworthiness of its customers and does not require collateral. The Company has not experienced any
material losses related to receivables from individual customers, or groups of customers. The Company maintains an allowance for doubtful accounts,
which was $0.1 million and zero as of December 31, 2019 and 2018, respectively. During the year ended December 31, 2019, bad debt expense was $0.1
million and included in selling, general and administrative expenses. The Company had no bad debt expense in 2018 and 2017.
Significant customers are those that represent more than 10% of the Company’s total revenues or accounts receivable balance at each respective
balance sheet date. For each significant customer, revenue as a percentage of total revenues and accounts receivable as a percentage of total accounts
receivable are as follows:
VA MVP
Pfizer Inc.
Merck & Co., Inc.
Customer A
Customer B
Indivumed GmbH
* Less than 10% of revenues or accounts receivable
Revenue
Year Ended December 31,
2018
2019
Accounts Receivable
As of December 31,
2017
2019
2018
49%
10%
12%
*
*
*
*
*
11%
13%
10%
*
19%
23%
*
*
*
30%
*
33%
10%
17%
10%
*
67%
13%
*
*
*
*
78
Revenue Recognition
The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board (“FASB”) Accounting
Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“Topic 606”).
Revenue Recognition
The revenue guidance provides a five-step framework through which revenue is recognized when control of promised goods or services is
transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To
determine revenue recognition for arrangements that the Company concludes are within the scope of Topic 606, management performs the following five
steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract(s); (iii) determines the transaction price,
including whether there are any constraints on variable consideration; (iv) allocates the transaction price to the performance obligations; and (v) recognizes
revenue when (or as) the Company satisfies a performance obligation. At contract inception, once a contract is determined to be within the scope of the
new revenue standard, the Company assesses whether individual goods or services promised within each contract are distinct and, therefore, represent
separate performance obligations.
The Company derives revenues from sequencing and data analysis services to support the development of personalized cancer vaccines and other
next-generation cancer immunotherapies. The Company’s contracts are in the form of a combination of signed agreements, statements of work, and/or
purchase orders. Under Topic 606, the Company accounts for a contract with a customer when there is approval and commitment from both parties, the
rights of the parties are identified, payment terms are identified, the contract has commercial substance, and it is probable that the Company will collect
substantially all of the consideration to which it will be entitled.
The sequencing and data analysis services are the only distinct services that meet the definition of a performance obligation and are accounted
for as one performance obligation under Topic 606. The Company recognizes revenue from such services at the point in time when control of the test
results is transferred to the customer. The Company has elected to exclude all sales and value added taxes from the measurement of the transaction price.
Sequencing and data analysis services are based on a fixed price per test.
Payment terms and conditions vary by contract and customer. The Company’s standard payment terms are less than 90 days from the invoice
date. In instances where the timing of the Company’s revenue recognition differs from the timing of its invoicing, the Company does not assess whether a
contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the
transfer of the promised services to the customer will be one year or less. After assessing each of its revenue-generating arrangements to determine whether
a significant financing component exists, the Company concluded that a significant financing component does not exist in any of its arrangements. The
primary purpose of the Company’s invoicing terms is to provide customers with simplified and predictable ways of purchasing the Company’s services and
to provide payment protection for the Company.
Practical Expedients and Exemptions
As a practical expedient, the Company recognizes the incremental costs of obtaining contracts, such as sales commissions, as an expense when
incurred since the amortization period of the asset the Company otherwise would have recognized is one year or less. Sales commissions are recorded
within selling, general, and administrative expenses in the consolidated statements of operations.
Costs of Revenues
The Company’s costs of revenues primarily consist of production materials, personnel costs (e.g., salaries, bonuses, benefit, and stock-based
compensation), cost of expensed equipment, consumables and laboratory supplies, information technology (“IT”) and facility costs, and depreciation and
service maintenance contracts on capitalized equipment.
Research and Development Expenses
The Company charges research and development costs to expenses as incurred, including lab and automation development costs. The expenses
primarily consist of employee-related costs (including stock-based compensation), laboratory and automation supplies and equipment, and related
depreciation and amortization expenses.
Stock-Based Compensation
For options granted to employees, non-employees, and directors, stock-based compensation is measured at grant date based on the fair value of
the award. The Company determines the grant-date fair value of the options using the Black-Scholes option-pricing model. The Company determines fair
value of restricted stock unit awards using the closing market price of the Company’s common stock on the date of grant. The grant-date fair value of
awards is amortized over the employees’ requisite service period or
79
the non-employees’ vesting period as the goods are received or services rendered. Forfeitures are accounted for as they occur. Additionally, the Company’s
2019 Employee Stock Purchase Plan is deemed to be a compensatory plan and therefore is included in stock-based compensation expense.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary is the British pounds sterling. In preparing its consolidated financial statements, the
Company is required to translate the financial statements of this subsidiary from British pounds sterling to U.S. dollars. Accordingly, monetary assets and
liabilities of the Company’s subsidiary are remeasured using exchange rates in effect at the end of the period. Costs in the local currency are remeasured
using average exchange rates for the period, except for costs related to those consolidated balance sheet items that are remeasured using historical exchange
rates. Since the Company’s functional currency is deemed to be the local currency, any gain or loss associated with the translation of its consolidated
financial statements is included as a component of stockholders’ equity (deficit), in accumulated other comprehensive income (loss).
Comprehensive Loss
Comprehensive loss includes all changes in equity (net assets) during the period from nonowner sources. The Company’s comprehensive loss
consists of its net loss, its cumulative translation adjustments, and its unrealized gains or losses on available-for-sale debt securities.
Income Taxes
The Company uses the asset and liability method under ASC Topic 740, Income Taxes, in accounting for income taxes. Deferred tax assets and
liabilities are recognized for the estimated future tax consequences attributable to differences between the consolidated financial statement carrying
amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to
apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred tax expenses or benefits are the
result of changes in the deferred tax assets and liabilities. Valuation allowances are established when necessary to reduce deferred tax assets where it is
more likely than not that the deferred tax assets will not be realized.
ASC Topic 740 clarifies the accounting for uncertainty in income taxes recognized in the financial statements. ASC Topic 740 provides that a tax
benefit from an uncertain tax position may be recognized when it is more likely than not that the position will be sustained upon audit, including
resolutions of any related appeals or litigation processes, based on the technical merits of the position. ASC Topic 740 also provides guidance on
measurement, derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the accompanying
consolidated statements of operations. Accrued interest and penalties are included within the related liability line in the consolidated balance sheets.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of
shares of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by
dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities
outstanding for the period. For purposes of the diluted net loss per share calculation, the redeemable convertible preferred stock, convertible preferred stock
warrants, common stock warrants, common stock subject to repurchase, and stock options are considered to be potentially dilutive securities. Basic and
diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as
the redeemable convertible preferred stock is considered a participating security. The Company’s participating securities do not have a contractual
obligation to share in the Company’s losses. As such, the net loss is attributed entirely to common stockholders. Because the Company has reported a net
loss for the reporting periods presented, the diluted net loss per common share is the same as basic net loss per common share for those periods.
Cash and Cash Equivalents
Cash equivalents consist of highly liquid investments with maturities at the time of purchase of three months or less. Cash equivalents include
bank demand deposits and money market accounts that invest primarily in cash, U.S. Treasury bills, notes, and other obligations issued or guaranteed as to
principal and interest by the U.S. Government, its agencies or instrumentalities, and repurchase agreements secured by such obligations or cash. Cash
equivalents also include commercial paper, which are marketable debt securities recorded at fair value and accounted for in the same manner as other
marketable debt securities described below.
80
Short-term Investments
The Company’s investments in marketable debt securities are classified as available-for-sale and recorded at fair value. Investments with original
maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities
beyond one year may be classified as short-term based on their highly liquid nature and because such marketable securities represent the investment of cash
that is available for current operations. Short-term investments primarily consist of U.S. agency bonds, commercial paper, corporate bonds, asset-backed
securities, and U.S. treasuries.
Unrealized gains and losses are included in accumulated other comprehensive loss in stockholders’ equity (deficit). Any discount or premium
arising at purchase is accreted or amortized to interest income or expense. Realized gains and losses and declines in fair value, if any, judged to be other-
than-temporary are reported in other (expense) income, net. When securities are sold, any associated unrealized gain or loss initially recorded as a separate
component of stockholders’ equity (deficit) is reclassified out of stockholders’ equity (deficit) on a specific-identification basis and recorded in earnings for
the period.
The Company periodically evaluates whether declines in fair values of its investments below their book values are other-than-temporary. This
evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability
and intent to hold the marketable security until a forecasted recovery occurs. Factors considered include quoted market prices, recent financial results and
operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, other publicly
available information that may affect the value of the marketable security, duration and severity of the decline in value, and management’s strategy and
intentions for holding the marketable security. To date, the Company has not recorded any impairment charges on its marketable securities related to other-
than-temporary declines in market value.
Fair Value Measurements
Financial assets and liabilities are recorded at fair value. Fair value is defined as the price that would be received to sell an asset or paid to
transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The hierarchy below lists three levels of fair
value based on the extent to which inputs used in measuring fair value are observable in the market. Observable inputs reflect market data obtained from
independent sources while unobservable inputs reflect market assumptions made by the reporting entity.
The three-level hierarchy for the inputs to valuation techniques used to measure fair value is briefly summarized as follows:
Level 1 — Unadjusted quoted prices in active markets that are accessible to the reporting entity at the measurement date for identical assets and
liabilities.
Level 2 — Inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for
substantially the full term of the asset or liability. Level 2 inputs include the following:
•
•
•
•
Quoted prices for similar assets and liabilities in active markets.
Quoted prices for identical or similar assets or liabilities in markets that are not active.
Observable inputs other than quoted prices that are used in the valuation of the assets or liabilities (e.g., interest rate and yield curve quotes
at commonly quoted intervals).
Inputs that are derived principally from or are corroborated by observable market data by correlation or other means.
Level 3 — Unobservable inputs for the assets or liabilities (i.e., supported by little or no market activity). Level 3 inputs include management’s
own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).
This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when
determining fair value.
Accounts Receivable, net
Trade accounts receivable are recorded at the invoiced amount and are noninterest bearing. At each reporting period, management reviews all
outstanding customer balances to determine if the facts and circumstances of each customer relationship indicate the need for a reserve. A reserve is
recorded when it is probable that a loss has been incurred based on past events and conditions existing at the date of the financial statements, and the loss is
reasonably estimated.
81
Inventory and Other Deferred Costs
Inventories, consisting of supplies used in the Company’s sequencing and data analysis contracts, are valued at the lower of cost or net realizable
value. Cost is determined using actual costs, on a first-in, first-out basis.
Other deferred costs relate to work in process for costs incurred on sequencing and data analysis contracts that have not been completed or
recognized as revenues. Other deferred costs represent materials used in sequencing services, labor, and overhead allocations.
Property and Equipment, Net
Property and equipment are recorded at cost, less accumulated depreciation and amortization, and are depreciated on a straight-line basis over the
estimated useful lives of the related assets, which is generally three to five years for computer equipment, two years for software, three years for furniture
and equipment, and five years for machinery and equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated
useful life of the related asset. Upon retirement or sale, the cost and related accumulated depreciation and amortization are removed from the consolidated
balance sheet, and the resulting gain or loss is reflected in the consolidated statements of operations. Maintenance and repairs that are not considered
improvements and do not extend the useful lives of the assets are charged to operations as incurred.
Construction-in-process assets consist primarily of computer equipment and machinery and equipment that have not yet been placed in service.
These assets are stated at cost and are not depreciated. Once the assets are placed into service, assets are reclassified to the appropriate asset class based on
their nature and depreciated in accordance with the useful lives above.
Internally used software, whether purchased or developed, is capitalized at cost and amortized on a straight-line basis over its estimated useful
life. Costs associated with internally developed software are expensed until the point at which the project has reached the development stage. Subsequent
additions, modifications, or upgrades to internal-use software are capitalized only to the extent that they provide additional functionality. Software
maintenance and training costs are expensed in the period in which they are incurred. The capitalization of software requires judgment in determining when
a project has reached the development stage and the period over which the Company expects to benefit from the use of that software.
Compound Derivative Instrument
The convertible notes issued in June 2017 (see Note 6) contained embedded features that provided the lenders with multiple settlement
alternatives. Certain of these settlement features provided the lenders a right to a fixed number of the Company’s shares upon conversion of the notes (the
“conversion option”). Other settlement features provided the lenders the right or the obligation to receive cash or a variable number of shares upon the
completion of a capital-raising transaction, change of control, or default of the Company (the “redemption features”).
Certain conversion and redemption features embedded in the convertible notes met the requirements for separate accounting and were accounted
for as a single, compound derivative instrument. The compound derivative instrument was recorded at fair value at inception and was subject to
remeasurement to fair value at each consolidated balance sheet date, with the change in fair value reflected as other (expense) income in the consolidated
statements of operations. The compound derivative instrument was recorded as a compound derivative liability at fair value, which was $0.5 million as of
the issuance date and zero and $0.7 million as of December 31, 2018 and 2017, respectively (see Note 5). Upon modification of the convertible notes on
August 20, 2018 (see Note 6), the compound derivative instrument was eliminated.
Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In May 2014, the FASB issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU
No. 2014-09”). Subsequently, the FASB also issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606), which adjusted the effective
date of ASU No. 2014-09; ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting
Revenue Gross versus Net), which amends the principal-versus-agent implementation guidance and illustrations in ASU No. 2014-09; ASU No. 2016-10,
Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies identifying performance
obligation and licensing implementation guidance and illustrations in ASU No. 2014-09; and ASU No. 2016-12, Revenue from Contracts with Customers
(Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses implementation issues and is intended to reduce the cost and
complexity of applying the new revenue standard in ASU No. 2014-09 (collectively, the “Revenue ASUs”).
The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenues arising from contracts
with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning
after December 15, 2017. The guidance permits two methods of adoption: retrospectively to
82
each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance
recognized at the date of initial application (the modified retrospective method). The Company performed a detailed review of its revenue agreements and
assessed the differences in accounting for such contracts under this guidance compared with previous revenue accounting standards. On January 1, 2017,
the Company early adopted ASU No. 2014-09 using the full retrospective method. The adoption of this standard did not have a material impact on the
Company’s consolidated financial statements. Results for all periods presented are under ASC Topic 606.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU No. 2016-02”). In July 2018, the FASB issued ASU No. 2018-
10, Codification Improvements to Topic 842, Leases, which provides clarification to ASU 2016-02. These ASUs (collectively, the “new lease standard”)
require an entity to recognize a lease liability and a right-of-use (“ROU”) asset on the balance sheet for leases with lease terms of more than 12 months.
Lessor accounting is largely unchanged, while lessees will no longer be provided with a source of off-balance sheet financing. This guidance is effective for
fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In July 2018, the FASB issued ASU No. 2018-11,
Leases (Topic 842) —Targeted Improvements, which allows entities to elect a modified retrospective transition method where entities may continue to
apply the existing lease guidance during the comparative periods and apply the new lease requirements through a cumulative effect adjustment in the period
of adoption rather than in the earliest period presented.
On January 1, 2019, the Company adopted ASU No. 2016-02, and its associated amendments using the modified retrospective transition method
by applying the new standard to all leases existing at the date of initial application and not restating comparative periods. There was no cumulative-effect
adjustment recorded to retained earnings upon adoption. Under the standard, a lessee is required to recognize a lease liability and ROU asset for all leases.
The new guidance also modified the classification criteria and requires additional disclosures to enable users of financial statements to understand the
amount, timing, and uncertainty of cash flows arising from leases. Consistent with current guidance, a lessee’s recognition, measurement, and presentation
of expenses and cash flows arising from a lease continues to depend primarily on its classification. The Company elected the package of practical
expedients permitted under the transition guidance, which allowed the Company to carryforward its historical lease classification, its assessment as to
whether a contract was or contains a lease, and its initial direct costs for any leases that existed prior to January 1, 2019. The Company also elected the
practical expedient not to separate lease and non-lease components. In addition, the Company elected the short-term lease exception as a practical
expedient.
At the date of adoption, the Company derecognized a deferred rent liability in the amount of $0.3 million, and recognized a ROU asset and
respective lease liability in the amount of $1.7 million and $2.0 million, respectively. As of December 31, 2019, lease liabilities in the amount of $1.4
million and $0.6 million are included in “Accrued and other current liabilities” and “Other long-term liabilities,” respectively.
New Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses
on certain types of financial instruments, including trade receivables. The accounting update also made minor changes to the impairment model for
available-for-sale debt securities. In November of 2019, the FASB delayed the effective date for Smaller Reporting Companies to the first quarter of 2023.
The Company is currently evaluating the impact of the new guidance on its consolidated financial statements and related disclosures. The Company will
apply the new guidance by means of a cumulative-effect adjustment to the opening retained earnings as of the beginning of the first reporting period in
which the guidance is effective.
JOBS Act Accounting Election
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Under the JOBS Act,
emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as
those standards apply to private companies. The Company has irrevocably elected not to avail itself of this exemption from new or revised accounting
standards, and therefore, the Company will be subject to the same new or revised accounting standards as other public companies that are not emerging
growth companies.
Note 3. Revenues
The following table presents the Company’s revenues disaggregated by customer type (in thousands):
VA MVP
All other customers
Total
2019
Year Ended December 31,
2018
2017
$
$
43,545 $
21,662
65,207 $
18,601 $
19,173
37,774 $
421
8,972
9,393
83
Revenues from countries outside of the United States, based on the billing addresses of customers, represented 4%, 3%, and 2% of the
Company’s revenues for the years ended December 31, 2019, 2018 ,and 2017, respectively.
Contract Assets and Liabilities
The Company had no contract assets as of December 31, 2019 and 2018.
The Company’s contract liabilities consist of customer deposits in excess of revenues recognized and are presented as current liabilities in the
consolidated balance sheets.
The balance of contract liabilities was $36.0 million and $42.9 million as of December 31, 2019 and 2018, respectively. Revenues recognized in
2019, 2018, and 2017 that were included in the contract liability balance at the beginning of each reporting period were $35.4 million, $16.0 million, and
$1.1 million, respectively.
Revenues allocated to remaining performance obligations represent contracted revenues that have not yet been recognized (“contracted not
recognized revenues”), which include VA MVP contract liabilities and amounts that will be invoiced and recognized as revenues in future periods.
Contracted not recognized revenues were $68.8 million as of December 31, 2019, which we expect to recognize as revenues over the next 15 months.
Note 4. Balance Sheet Details
Inventory and other deferred costs consist of the following (in thousands):
Raw materials
Other deferred costs
Total inventory and other deferred costs
Property and equipment, net consists of the following (in thousands):
Machinery and equipment
Computer equipment
Furniture and fixtures
Leasehold improvement
Capitalized software costs
Computer software costs
Construction in progress
Total
Less: Accumulated depreciation and amortization
Property and equipment, net
December 31,
2019
2018
1,424 $
3,182
4,606 $
2,134
1,298
3,432
December 31,
2019
2018
12,511 $
8,855
368
987
—
198
234
23,153 $
(9,047)
14,106 $
7,951
6,822
150
1,016
182
202
333
16,656
(5,204)
11,452
$
$
$
$
$
Depreciation and amortization expense for the years ended December 31, 2019, 2018, and 2017 was $4.7 million, $3.1 million, and $1.2 million,
respectively.
84
Accrued and other current liabilities consist of the following (in thousands):
Accrued compensation
Operating lease right-of-use liabilities
Accrued liabilities
Accrued taxes
Accrued interest
Deferred rent
Other current liabilities
Total accrued and other current liabilities
Note 5. Fair Value Measurements
December 31,
2019
2018
$
$
4,147 $
1,361
689
210
—
—
241
6,648 $
2,843
—
59
181
207
99
3
3,392
The following tables show the Company’s financial assets and liabilities measured at fair value on a recurring basis and the level of inputs used
in such measurements as of December 31, 2019 and 2018 (in thousands):
Assets
Cash and cash equivalents
Cash
Money market funds
Commercial paper
Total cash and cash equivalents
Short-term investments
Commercial paper
U.S. government securities
Corporate debt securities
U.S. agency securities
Asset-backed securities
Total short-term investments
Total assets measured at fair value
Assets
Cash and cash equivalents
Cash
Money market funds
Total cash and cash equivalents
Total assets measured at fair value
Liabilities
Long-term liabilities
Convertible preferred stock warrants liability
Total liabilities measured at fair value
Adjusted Cost
Unrealized
Gains
Unrealized
Losses
Fair Value
Fair Value Level
As of December 31, 2019
$
$
1,271 $
12,495
41,281
55,047
17,898
4,011
13,953
32,776
4,598
73,236
128,283 $
— $
—
—
—
—
—
1
20
—
21
21 $
— $
—
(1)
(1)
(6)
—
(6)
(2)
—
(14)
(15) $
1,271
12,495
41,280
55,046
17,892
4,011
13,948
32,794
4,598
73,243
128,289
Level 1
Level 2
Level 2
Level 2
Level 2
Level 2
Level 2
Adjusted Cost
Unrealized
Gains
Unrealized
Losses
Fair Value
Fair Value Level
As of December 31, 2018
$
$
1,602 $
18,142
19,744
19,744 $
— $
—
—
— $
— $
—
—
— $
1,602
18,142
19,744
19,744
Level 1
$
$
683
683
Level 3
There have been no realized gains or losses on sales of marketable securities for the periods presented. The Company began investing in
marketable debt securities during the third quarter of 2019 and, therefore, no security has been in an unrealized loss position for 12 months or greater. The
Company determined that it did have the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or
recovery. As of December 31, 2019, the Company does not consider any of its marketable debt securities to be other-than-temporarily impaired.
85
The Company’s marketable debt securities at December 31, 2019 have maturities due in one year or less, except for debt securities with an
aggregate cost basis and fair value of $3.0 million that have maturities of 13 months.
The Black-Scholes option-pricing model was used to estimate the fair value of the convertible preferred stock warrants at the date of issuance
and at each subsequent consolidated balance sheet date. The fair value of the convertible preferred stock warrants was also estimated at the time of
conversion to common stock warrants (see Note 10). Under this option-pricing model, convertible preferred stock warrants were valued by creating a series
of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The values of the redeemable
convertible preferred stock and common stock are inferred by analyzing these options.
The fair value of each convertible preferred stock warrant was estimated using the Black-Scholes option-pricing model with the assumptions
described below. Upon conversion to common stock warrants in the second quarter of 2019 (see Note 10), no further fair value measurements were made.
Therefore, there is no activity with respect to periods after the second quarter of 2019. For the periods indicated, the Company has limited historical
volatility information available, and the expected volatility was based on actual volatility for comparable public companies projected over the expected
terms of the warrants. The Company did not apply a forfeiture rate to the warrants as there is not enough historical information available to estimate such a
rate. The risk-free interest rate was based on the U.S. Treasury yield curve over the expected term of the warrants.
Expected term (in years)
Volatility
Risk-free interest rate
Dividend yield
Period Ended
June 24,
2019
5.01 - 5.26
57.20% - 57.24%
1.75%
–%
Year Ended
December 31,
2018
5.17 - 7.00
55.56% - 56.42%
2.58% - 3.01%
–%
Year Ended
December 31,
2017
6.75 - 7.50
56.07% - 69.87%
1.97% - 2.33%
–%
The fair value of the compound derivative instrument was estimated at the date of inception in June 2017 and at each subsequent consolidated
balance sheet date using a hybrid method that combines probability-weighted and with-or-without methods using unobservable inputs, which are classified
as Level 3 within the fair value hierarchy. The primary inputs for this approach included the probability of achieving various settlement scenarios that
provide the lenders the right or the obligation to receive cash or a variable number of shares upon the completion of a capital transaction. The probability
assumptions related to estimating various settlement scenarios as of December 31, 2018 and 2017, and the inception date ranged between 0.2% and 70%,
and a discount rate of 35.1% was applied to estimated future cash flows. After the initial measurement, changes in the fair value of this compound
derivative were recorded in other income (expense), net.
The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands):
Balance—December 31, 2016
Issuance of convertible preferred stock warrants
Initial fair value of derivative liability
Change in fair value
Balance—December 31, 2017
Initial fair value of derivative asset
Change in fair value
Elimination as a result of debt extinguishment
Balance—December 31, 2018
Change in fair value
Reclassification of warrant liability to additional paid in capital on conversion
Balance—December 31, 2019
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Warrant
Liability
Derivative
Asset
Derivative
Liability
$
$
$
$
59 $
169
—
64
292 $
—
391
—
683 $
1,403
(2,086)
— $
— $
—
—
—
— $
623
(97)
(526)
— $
—
—
— $
—
—
509
162
671
—
(671)
—
—
—
—
—
Note 6. Borrowings
Amounts outstanding under the Company’s financing arrangements consisted of the following (in thousands):
Credit agreement
Revolving Loan
Total principal payments due
Less: Reduction in carrying value
Total amounts outstanding
Less: Current portion
Long-Term portion
Term Loan
December 31,
2019
December 31,
2018
$
$
$
$
— $
— $
—
— $
—
— $
5,000
5,000
(4)
4,996
(4,996)
—
In September 2014, the Company entered into a loan and security agreement with Silicon Valley Bank to borrow up to $3.0 million under an
equipment loan to be secured by the equipment financed (the “Term Loan”). On October 3, 2014, the Company borrowed $2.4 million under the Term
Loan. The Term Loan required 12 interest-only payments, followed by 36 equal monthly installments of principal, plus interest, which began on October 3,
2015.
In connection with the Term Loan, the Company issued to the bank a warrant exercisable for ten years from the date of grant to purchase 22,489
shares of the Company’s Series B redeemable convertible preferred stock at an exercise price of $4.60 per share (see Note 10).
The estimated fair value of the warrants upon draw down of $0.1 million was based on the Black-Scholes option-pricing model. The Company
recorded the fair value of the warrant at issuance as a reduction in the debt-carrying value and as a warrant liability. The debt-carrying value reduction was
accreted using the effective interest method as additional interest expense over the contractual period of four years for the Term Loan.
On September 30, 2018, the Term Loan was repaid in full.
Revolving Loan
In June 2017, the Company entered into a $10.0 million revolving loan and security agreement (the “Revolving Loan”) with TriplePoint Capital
LLC (“TriplePoint”). Borrowings under the Revolving Loan bear an interest rate of prime, plus 6.75%. The Revolving Loan also has a 5.5% end of term
loan payment on the highest outstanding principal amount. The Revolving Loan requires monthly interest-only payments until the maturity date. The
Revolving Loan’s original maturity date was December 31, 2018, and in December 2018 the maturity date was further extended until March 22, 2019.
Upon determining that the change in cash flows between the previous and current credit facility was not greater than 10%, the Company accounted for the
transaction as a debt modification.
As of December 31, 2018, the Company’s outstanding principal under the Revolving Loan was $5.0 million and $5.0 million was available to
borrow.
In connection with the Revolving Loan, the Company issued to TriplePoint a warrant to purchase up to 62,096 shares of the Company’s Series C
redeemable convertible preferred stock at an exercise price of $8.052 per share exercisable for seven years from June 28, 2017 (see Note 10).
The estimated fair value of the warrant upon draw down of $0.1 million was based on the Black-Scholes option-pricing model. The Company
recorded the fair value of the warrant at issuance as a reduction in the debt-carrying value and as a warrant liability. The debt-carrying value reduction was
accreted using the effective interest method as additional interest expense over the contractual period of 1.5 years for the Revolving Loan.
The Revolving Loan had an effective interest rate of 19.22% per year. The Revolving Loan interest expense for the year ended December 31,
2018 was $0.9 million. Interest expense for the year ended December 31, 2019 was not material.
The Company accrued $0.2 million as of December 31, 2018 related to accretion of final payment due at maturity per the agreement using the
effective interest rate method.
On March 22, 2019, this Revolving Loan was repaid in full.
87
Growth Capital Loan
On March 22, 2019, the Company entered into a growth capital loan (the “Growth Capital Loan”) with TriplePoint to provide for a $20.0 million
growth capital loan facility and as of June 30, 2019, had drawn down the full $20.0 million available under the facility. The Company used $5.1 million of
the Growth Capital Loan to repay, in its entirety, all amounts outstanding under the Revolving Loan. Borrowings under the Growth Capital Loan bore
interest at a floating rate of prime, plus 5.00%, for borrowings up to $15.0 million and the prime rate plus 6.50% for borrowings greater than $15.0 million.
Under the agreement, the Company was required to make monthly interest-only payments through April 1, 2020 and was required to make 36 equal
monthly payments of principal, plus accrued interest, from April 1, 2020 through March 1, 2023, when all unpaid principal and interest was to become due
and payable. The agreement allowed voluntary prepayment of all, but not part, of the outstanding principal at any time prior to the maturity date, subject to
a prepayment fee of 1.00% of the outstanding balance if prepaid in months one through 12 of the loan term. In addition to the final payment, the Company
paid an amount equal to 2.75% of each principal amount drawn under this growth capital loan facility.
In connection with the Growth Capital Loan, the Company issued a warrant to purchase 65,502 shares of common stock to TriplePoint at an
exercise price of $9.16 per share exercisable for seven years from March 22, 2019. The Company recorded the issuance-date fair value of the warrant of
$0.6 million and fees paid to TriplePoint of $0.3 million as a debt discount, which was amortized over the term of the Growth Capital Loan using the
effective interest method.
Upon issuance, the Growth Capital Loan had an effective interest rate of 15.23% per year. Interest expense for the year ended December 31,
2019 was $1.0 million.
On August 14, 2019, the Company paid off the Growth Capital Loan in its entirety. In connection with this debt repayment, the Company
recorded a $1.7 million loss on extinguishment of debt in the consolidated statements of operations.
Convertible Notes
On June 29, 2017, the Company entered into a convertible promissory note agreement with certain existing redeemable convertible preferred
stockholders and third parties (collectively, the “Investors”) for the issuance of convertible promissory notes with a face value of $12.2 million (the
“Convertible Notes”). Under the terms of the Convertible Notes agreement, the Convertible Notes bore interest of 8.00% per annum, with a maturity date
of June 28, 2018. In the event that the Company issued and sold shares of its equity securities (the “Equity Securities”) to Investors on or before the
maturity date in an equity financing with total proceeds to the Company of not less than $10 million (including the conversion of the Convertible Notes or
other convertible securities issued for capital raising purposes) (a “Qualified Financing”), then the outstanding principal amount of the Convertible Notes
and any unpaid accrued interest would have automatically converted in whole without any further action by the holder into such Equity Securities sold in
the Qualified Financing at a conversion price equal to the price paid per share for Equity Securities by the Investors in the Qualified Financing multiplied
by 0.8. If the Company consummated a change of control while the Convertible Notes remained outstanding, the Company would have repaid the holders
in cash an amount equal to 150% of the outstanding principal amount of the Convertible Notes, plus any unpaid accrued interest on the original principal.
The Convertible Notes had customary events of default.
Certain conversion and redemption features of the Convertible Notes met the requirements for separate accounting and were accounted for as a
single, compound derivative instrument. The compound derivative instrument was recorded at fair value at inception and was subject to remeasurement to
fair value at each consolidated balance sheet date, with any changes in fair value recognized in the consolidated statements of operations as other (expense)
income, net. The estimated fair value of the compound derivative instrument was $0.5 million at issuance and was recorded as a reduction in the carrying
value of the Convertible Notes and as a single, compound derivative liability. The Convertible Notes carrying value reduction was accreted using the
effective interest method as interest expense over the Convertible Notes contractual period of one year. The Convertible Notes had an effective interest rate
of 12.69% per year.
On May 31, 2018, the original maturity date for the Convertible Notes was extended to June 28, 2019 (previously June 28, 2018). The maturity
date extension was deemed substantial and was accounted for as a debt extinguishment. In connection with the debt extinguishment on May 31, 2018, the
fair value of the Convertible Notes was allocated between the carrying amount of the Convertible Notes and accrued interest of $13.1 million, a compound
derivative asset of $0.6 million, and an equity component of $3.9 million, which was credited to additional paid-in capital within the consolidated
statements of redeemable convertible preferred stock and stockholders’ equity (deficit). A $3.3 million loss on debt extinguishment was also recorded in
the consolidated statements of operations. The new carrying value of the Convertible Notes was accreted using the effective interest method as interest
expense over the new contractual period of 1.1 years.
88
On August 20, 2018, the maturity date for the Convertible Notes was extended to September 20, 2018 (previously June 28, 2019). The term
change was deemed substantial and was accounted for as a debt extinguishment. In connection with the debt extinguishment on August 20, 2018, the fair
value of the Convertible Notes was allocated between the new carrying amount of the Convertible Notes and accrued interest of $13.4 million, and an
equity component of $0.8 million, which resulted in a credit to additional paid-in capital. Upon modification, the compound derivative asset was
eliminated. A $0.8 million loss on debt extinguishment was also recorded in the consolidated statements of operations. The new carrying value of
Convertible Notes was accreted using the effective interest method as interest expense over the new contractual period of one month.
On September 20, 2018, upon the maturity of the Convertible Notes, the carrying amount, including accrued interest of $13.4 million, was
converted into 1,667,997 shares of the Company’s Series C redeemable convertible preferred stock at a conversion price equal to $8.052 per share. No gain
or loss was recorded on the conversion.
The Convertible Notes interest expense for the year ended December 31, 2018 was $0.9 million.
Note 7. Leases
Operating Lease Obligations
In February 2015, the Company entered into a noncancelable operating lease for approximately 31,280 square feet of space used for its current
laboratory and office space. The lease expires on November 30, 2020 and includes an option to extend the term for a period of three years immediately
following the expiration of the term with rent payments equal to then current fair market rental for the space.
For the 2018 periods presented, the Company recognized rent expense on a straight-line basis over the noncancelable lease term. The Company’s
rent expense was $1.1 million for the year ended December 31, 2018.
In August 2019, the Company entered into a noncancelable operating lease for a co-located data center space. The lease expires on September 1,
2022 and includes an option to extend the term for a period of three years immediately following the expiration of the term with rent payments to be
negotiated upon such a renewal.
The Company adopted the new lease standard as of January 1, 2019. In determining the present value of lease payments, the Company uses its
incremental borrowing rate based on the information available at the lease commencement date if the rate implicit in the lease is not readily determinable.
At the date of adoption, the Company determined the amounts of lease liability related to the laboratory and office space lease using a discount rate of
8.0%, which represented the Company’s incremental borrowing rate. The Company determines its incremental borrowing rate for lease liability using its
current borrowing rate, adjusted for various factors including level of collateralization and term. With respect to the lease for co-located data center space,
the Company determined the amounts of lease liability using a discount rate of 6.6%, and the Company recognized a $1.1 million operating lease right-of-
use asset and lease liability on the lease commencement date in September 2019. The Company determined that the optional renewal periods for both
leases were not reasonably certain to be exercised as of the lease commencement dates. As a result, the optional renewal periods were not recognized as
part of the right-of-use asset or lease liability.
Operating lease cost for the year ended December 31, 2019 was $1.1 million. Cash paid for operating lease liabilities, included in cash flow from
operating activities in the Consolidated Statement of Cash Flows was $1.2 million for the year ended December 31, 2019. As of December 31, 2019, the
weighted average remaining lease term for the operating leases was 1.8 years and the weighted average incremental borrowing rate was 7.3%.
Future minimum noncancelable operating lease payments at December 31, 2018, determined in accordance with the Company’s historical lease
accounting standard (ASC 840), were as follows (in thousands):
2019
2020
Total future minimum lease payments
$
$
Amount
1,091
1,030
2,121
89
Future minimum lease payments under noncancelable operating leases as of December 31, 2019 were as follows (in thousands):
2020
2021
2022
Total future minimum lease payments
Less: Imputed interest
Present value of future minimum lease payments
Less: Current portion of operating lease liabilities
Operating lease liabilities - noncurrent
Note 8. Redeemable Convertible Preferred Stock
$
$
$
$
Amount
1,408
403
319
2,130
(130)
2,000
(1,361)
639
Series A redeemable convertible preferred stock, Series B redeemable convertible preferred stock, and Series C redeemable convertible preferred
stock (collectively the “Redeemable Convertible Preferred Stock”) outstanding consisted of the following as of December 31, 2018 and as of immediately
prior to the automatic conversion of the Redeemable Convertible Preferred Stock into common stock:
(in thousands, except share and per share data)
Series A
Series B
Series C
Total redeemable convertible preferred stock
December 31, 2018
Shares
Authorized
Shares Issued
and
Outstanding
Aggregate
Liquidation
Preference
31,250,000 7,812,497 $
19,288,150 4,799,548
24,700,000 5,862,697
75,238,150 18,474,742 $
20,500 $
22,078
47,206
89,784 $
Issuance
Costs
Net Carrying
Value
Original
Issuance
Price
Per Share
82 $
31
110
223 $
20,261 $
22,047
47,096
89,404
2.624
4.600
8.052
Immediately prior to the closing of the Company’s IPO, all shares of the Company’s then-outstanding Redeemable Convertible Preferred Stock,
as shown in the table above, automatically converted on a one-for-one basis into an aggregate of 18,474,703 shares of common stock. The Reverse Stock
Split was effected on a holder-by-holder basis with no fractional shares issued, which resulted in 39 fewer shares of common stock issued as compared to
the amounts shown in the above table.
Note 9. Stock-Based Compensation
2011 Equity Incentive Plan and 2019 Equity Incentive Plan
In 2011, the Company established its 2011 Equity Incentive Plan (the “2011 Plan”) that provided for the granting of stock options to employees
and nonemployees of the Company. Under the 2011 Plan, the Company had the ability to issue incentive stock options (“ISOs”), nonstatutory stock options
(“NSOs”), stock appreciation rights, restricted stock awards, and restricted stock unit awards (“RSUs”). Options under the 2011 Plan could be granted for
periods of up to 10 years. The ISOs could be granted at a price per share not less than the fair value at the date of grant. The exercise price of an ISO
granted to a 10% stockholder was not less than 110% of the estimated fair value of the shares on the date of grant, as determined by the board of directors
(the “Board”). Options granted to new hires generally vested over a four-year period, with 25% vesting at the end of one year and the remaining vesting
monthly thereafter; options granted as merit awards generally vested monthly over a four-year period.
For stock option grants issued prior to December 31, 2015, the Company allowed employees to exercise options granted under the 2011 Plan
prior to vesting (early exercise of stock options). The unvested shares are subject to the Company’s repurchase rights at the original purchase price.
Initially, the proceeds were recorded as an accrued liability from the early exercise of stock options and reclassified to common stock as the Company’s
repurchase rights lapsed. There were zero and 262 unvested shares subject to the Company’s repurchase rights as of December 31, 2019 and 2018,
respectively.
The Company’s Board adopted and the Company’s stockholders approved the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) in May
2019 and June 2019, respectively. The 2019 Plan became effective in June 2019 in connection with the Company’s IPO, and no further grants will be made
under the 2011 Plan. Shares reserved and remaining available for issuance under the 2011 Plan were added to the 2019 Plan reserve upon its effectiveness.
90
The 2019 Plan provides for the grant of ISOs, NSOs, stock appreciation rights, restricted stock awards, RSUs, performance-based stock awards,
and other forms of equity compensation. Additionally, the 2019 Plan provides for the grant of performance cash awards. ISOs may be granted only to the
Company’s employees and to any of the Company’s parent or subsidiary corporation’s employees. All other awards may be granted to employees,
including officers, and to non-employee directors and consultants of the Company and any of the Company’s affiliates. The exercise price of a stock option
generally cannot be less than 100% of the fair market value of our common stock on the date of grant. Options under the 2019 Plan may be granted for
periods of up to 10 years.
At December 31, 2018 there were 4,647,839 shares of common stock available for issuance under the 2011 Plan. At December 31, 2019 there
were 4,474,057 shares of common stock available for issuance under the 2011 Plan and 2,769,721 available for issuance under the 2019 Plan.
Stock Option Activity
A summary of the Company’s stock option activity under the 2011 Plan and 2019 Plan for the year ended December 31, 2019 is as follows:
(in thousands, except share and per share data)
Balance—December 31, 2016
Options granted
Options exercised
Options cancelled
Balance—December 31, 2017
Options granted
Options exercised
Options cancelled
Balance—December 31, 2018
Options granted
Options exercised
Options cancelled
Balance—December 31, 2019
Options vested and exercisable as of December 31, 2019
Outstanding Options
Weighted-
Average
Exercise Price
Weighted-
Average
Remaining
Contractual
Term (in years)
Aggregate
Intrinsic
Value
1.76
2.44
2.12
3.20
1.92
5.68
2.80
2.96
3.16
11.81
2.47
6.61
4.94
2.97
6.41 $
2,451
15
6.61 $
5,860
96
6.94 $
24,716
6.60 $
5.13 $
29,730
22,858
Number of
Shares
2,112,394 $
898,510
(30,625)
(95,752)
2,884,527 $
1,386,464
(34,426)
(126,435)
4,110,130 $
988,913
(287,932)
(79,676)
4,731,435 $
2,841,458 $
The aggregate intrinsic value of unexercised stock options is calculated as the difference between the closing price of the Company’s common
stock of $10.90 on December 31, 2019 and the exercise prices of the underlying stock options. Out-of-the money stock options are excluded from the
aggregate intrinsic value.
The weighted-average grant date fair value of options granted was $8.00, $5.68, and $2.44 per share for the twelve months ended December 31,
2019, 2018, and 2017, respectively. As of December 31, 2019, the unrecognized stock-based compensation of unvested options was $9.6 million, which is
expected to be recognized over a weighted-average period of 2.8 years.
Restricted Stock Units Activity
A summary of the Company’s RSUs activity under the 2019 Plan for the year ended December 31, 2019 is as follows:
(in thousands, except share and per share data)
Balance—December 31, 2018
RSUs granted
RSUs vested
RSUs cancelled
Balance—December 31, 2019
Unvested Restricted Stock Units
Weighted-Average
Grant Date
Fair Value
Aggregate
Fair Value
Number of
Shares
— $
120,000
—
—
120,000 $
—
8.86
—
—
8.86 $
1,308
91
The Company granted RSUs to employees to receive shares of the Company’s common stock. The RSUs awarded are subject to each
individual’s continued service to the Company through each applicable vesting date over a three-year period. The Company accounted for the fair value of
the RSUs using the closing market price of the Company’s common stock on the date of grant. The aggregate fair value of unvested RSUs is calculated
using the closing price of the Company’s common stock of $10.90 on December 31, 2019.
Amortization of stock-based compensation expense related to RSUs in 2019 was not material. As of December 31, 2019, the unrecognized stock-
based compensation of unvested RSUs was $1.0 million, which is expected to be recognized over a weighted-average period of 2.9 years.
Valuation of Stock Options
The Company estimated the fair value of stock options using the Black-Scholes option-pricing model. The fair value of stock options is
recognized on a straight-line basis over the requisite service periods of the awards.
The fair value of stock options was estimated using the following weighted-average assumptions:
Expected term (in years)
Volatility
Risk-free interest rate
Dividend yield
2019
5.00 - 6.87
Year Ended December 31,
2018
1.50 - 6.35
56.20 - 63.08%
1.53 - 2.52%
52.19 - 56.47%
2.62 - 2.88%
–%
–%
2017
5.97 - 6.95
56.05 - 65.78%
1.88 - 2.10%
–%
Expected Term. The expected term is calculated using the simplified method, which is available if there is insufficient historical data about
exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for
each grant, or for each vesting tranche for awards with graded vesting. The midpoint of the vesting date and the maximum contractual expiration date is
used as the expected term under this method. For awards with multiple vesting tranches, the times from grant until the midpoints for each of the tranches
may be averaged to provide an overall expected term.
Expected Volatility. The Company used an average historical stock price volatility of a peer group of publicly traded companies to be
representative of its expected future stock price volatility, as the Company did not have sufficient trading history for its common stock. For purposes of
identifying these peer companies, the Company considered the industry, stage of development, size, and financial leverage of potential comparable
companies. For each grant, the Company measured historical volatility over a period equivalent to the expected term.
Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with
remaining terms equivalent to the expected term of a stock award.
Expected Dividend Yield. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company
has estimated the dividend yield to be zero.
2019 Employee Stock Purchase Plan
In May 2019, the Board adopted the 2019 Employee Stock Purchase Plan (the “ESPP”), which was approved by the Company’s stockholders in
June 2019. A total of 250,000 shares of common stock are initially reserved for issuance under the ESPP. The number of shares may be increased in
accordance with the terms of the ESPP.
Subject to any plan limitations, the ESPP allows eligible employees to contribute, normally through payroll deductions, up to 15% of their
earnings for the purchase of the Company’s common stock at a discounted price per share. The price at which common stock is purchased under the ESPP
is equal to 85% of the fair market value of the Company’s common stock on the first or last day of the offering period, whichever is lower. Except for the
initial offering period, the ESPP provides for separate six-month offering periods beginning on May 1 and November 1 of each year. The initial offering
period ran from June 20, 2019 through October 31, 2019.
92
During the year ended December 31, 2019, 77,684 shares of common stock were purchased under the ESPP. The total compensation expense
related to the ESPP for the year ended December 31, 2019 was $0.3 million. The following range of assumptions were used to calculate stock-based
compensation for each stock purchase right granted under the ESPP: weighted-average expected life of 0.37 – 0.5 years; expected volatility of 59.1 –
59.9%; risk-free interest rate of 1.6 - 2.1%; and a zero dividend yield.
Stock-based Compensation Expense
The following is a summary of stock-based compensation expense by function (in thousands):
Costs of revenues
Research and development
Selling, general, and administrative
Total stock-based compensation expense
2019
Year Ended December 31,
2018
2017
$
$
480 $
903
3,475
4,858 $
177 $
429
711
1,317 $
74
225
454
753
During the year ended December 31, 2019, 67,418 shares with performance conditions vested. The awards were subject to two vesting criteria:
(i) a time-based service criterion, and (ii) a performance criterion of an initial public offering, which were met in connection with our June 20, 2019 IPO.
The Company recognized $0.3 million of stock-based compensation expense for all such awards. During the years ended December 31, 2018 and 2017, no
shares with performance conditions vested and no stock-based compensation expense was recognized related to shares with performance conditions.
Note 10. Redeemable Convertible Preferred Stock Warrants
In September 2014, in connection with the Term Loan (see Note 6), the Company issued a warrant to purchase 22,489 shares of its Series B
redeemable convertible preferred stock at an exercise price of $4.60 per share. The estimated fair value of the Series B convertible preferred stock warrant
on the date of issuance of $0.1 million was recorded as a debt reduction. As of the issuance date, the fair value of the Series B convertible preferred stock
warrant was calculated using the Black-Scholes option-pricing model and was based on a contractual term of ten years, a risk-free interest rate of 2.52%,
expected volatility of 66.53%, and 0% expected dividend yield.
In June 2017, as additional consideration for the Revolving Loan (see Note 6), the Company issued a warrant to purchase up to 62,096 shares of
its Series C redeemable convertible preferred stock at an exercise price of $8.052, subject to certain adjustments, such as any stock splits, stock dividends,
recapitalizations, reclassifications, combinations, or similar transactions. The remaining term of the Series C convertible preferred stock warrant is seven
years from June 28, 2017.
The estimated fair value of the Series C convertible preferred stock warrant on the date of issuance of $0.1 million was recorded as a debt
reduction. As of the issuance date, the fair value of the Series C convertible preferred stock warrant was calculated using the Black-Scholes option-pricing
model and was based on a contractual term of seven years, a risk-free interest rate of 1.97%, expected volatility of 64.33%, and 0% expected dividend
yield.
At initial recognition, the convertible preferred stock warrants were recorded at their estimated fair values and were subject to remeasurement at
each consolidated balance sheet date, with changes in fair value recognized as a component of net income. As of December 31, 2018, the fair values of the
convertible preferred stock warrants were calculated to be $0.7 million.
Immediately prior to the closing of the Company’s IPO, the redeemable convertible preferred stock warrants automatically converted to common
stock warrants. As a result of the automatic conversion of the redeemable convertible preferred stock warrants to common stock warrants, the Company
revalued the redeemable convertible preferred stock warrants as of the completion of the IPO and reclassified the outstanding preferred stock warrant
liability balance to additional paid-in capital with no further remeasurements as the common stock warrants are now deemed permanent equity. The fair
value transferred to additional paid-in capital was $2.1 million.
Subsequent to the conversion to a common stock warrant and before the end of the Company’s second quarter ended June 30, 2019, the common
stock warrant for 22,489 shares was exercised. As a result, the Company issued 19,069 shares of common stock as the contract allows a net share
settlement. Separately, the common stock warrant issued in June 2017 for 62,096 shares was still outstanding as of December 31, 2019.
93
Note 11. Common Stock Warrants
In connection with the sale of Series A redeemable convertible preferred stock in August 2011, the Company issued a warrant to purchase
188,643 shares of common stock to an investor who purchased Series A redeemable convertible preferred stock in August 2011 at an exercise price of
$0.04 per share. The Company recorded the issuance-date fair value of the warrant of $0.1 million in equity as the warrant met all criteria for equity
classification. The common stock warrant was exercised in June 2019 prior to the Company’s IPO and is no longer outstanding as of December 31, 2019.
In connection with the Growth Capital Loan agreement (see Note 6), the Company issued a warrant to purchase 65,502 shares of common stock
to the lender at an exercise price of $9.16 per share exercisable for seven years from March 22, 2019. The Company recorded the issuance-date fair value
of the warrant of $0.6 million in equity as the warrant met all criteria for equity classification. The warrant is still outstanding as of December 31, 2019.
Note 12. Commitments and Contingencies
Contingencies
The Company is subject to claims and assessments from time to time in the ordinary course of business. Accruals for litigation and contingencies
are reflected in the consolidated financial statements based on management’s assessment, including the advice of legal counsel, of the expected outcome of
litigation or other dispute resolution proceedings and/or the expected resolution of contingencies. Liabilities for estimated losses are accrued if the potential
losses from any claims or legal proceedings are considered probable and the amounts can be reasonably estimated. Significant judgment is required in both
the determination of probability of loss and the determination as to whether the amount can be reasonably estimated. Accruals are based only on
information available at the time of the assessment due to the uncertain nature of such matters. As additional information becomes available, management
reassesses potential liabilities related to pending claims and litigation and may revise its previous estimates, which could materially affect the Company’s
consolidated results of operations in a given period. As of December 31, 2019, the Company was not involved in any material legal proceedings.
Indemnification
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and
provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against
the Company in the future, but that have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to
its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.
Note 13. Net Loss per Share Attributable to Common Stockholders
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period.
Because the Company reported a net loss for the years ended December 31, 2019, 2018, and 2017, the number of shares used to calculate diluted net loss
per common share is the same as the number of shares used to calculate basic net loss per common share for those periods presented because the potentially
dilutive shares would have been antidilutive if included in the calculation.
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except
share and per share data):
Numerator:
2019
Year Ended December 31,
2018
2017
Net loss attributable to common stockholders
$
(25,084) $
(19,886) $
(23,598)
Denominator:
Weighted-average shares outstanding
Less: Weighted-average shares subject to repurchase
Weighted-average shares outstanding used in computing net loss per share attributable
to common stockholders — basic and diluted
18,011,955
(485)
3,063,516
(359)
18,011,470
3,063,157
Net loss per share attributable to common stockholders—basic and diluted
$
(1.39) $
(6.49) $
3,035,791
(4,155)
3,031,636
(7.78)
94
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable
to common stockholders for the periods presented because including them would have been antidilutive:
Redeemable convertible preferred stock
Conversion of Convertible Notes(1)
Common stock warrants
Series B preferred stock warrant
Series C preferred stock warrant
Options to purchase common stock
Unvested early exercised common stock options
Unvested Restricted Stock Units
Employee Stock Purchase Plan
Total
2019
Year Ended December 31,
2018
18,474,742
—
188,643
22,489
62,096
4,110,130
262
—
—
22,858,362
—
—
127,598
—
—
4,731,435
—
120,000
75,405
5,054,438
2017
16,806,746
1,580,151
188,643
22,489
62,096
2,884,527
2,213
—
—
21,546,865
(1) Calculated as $12.2 million principal and $0.5 million accrued but unpaid interest as of December 31, 2017.
Note 14. Income Taxes
For financial reporting purposes, loss before income taxes includes the following components (in thousands):
Domestic
Foreign
Loss before income taxes
Provision for Income Taxes
The provision for income taxes consists of the following (in thousands):
Current:
Federal
State
Foreign
Total current
Provision for income taxes
2019
Year Ended December 31,
2018
2017
(25,111) $
36
(25,075) $
(19,897) $
18
(19,879) $
(23,613)
20
(23,593)
2019
Year Ended December 31,
2018
2017
— $
1
8
9
9 $
— $
2
5
7
7 $
—
1
4
5
5
$
$
$
$
Income tax provision related to continuing operations differ from the amounts computed by applying the statutory income tax rate of 21% to
pretax loss in 2019 and 2018; and 35% to pretax loss in 2017 as follows (in thousands):
Federal statutory rate
Effect of:
State taxes
Change in valuation allowance
Rate impact due to tax reform
Research and development credit
Debt extinguishment
Other
Effective tax rate
2019
Year Ended December 31,
2018
2017
(21)%
(21)%
(35)%
(8)%
28%
–%
(3)%
–%
4%
–%
(3)%
21%
–%
(3)%
4%
2%
–%
(7)%
(9)%
51%
(2)%
–%
2%
–%
95
Tax Law Changes
The U.S. Tax Cuts and Jobs Act (the “Tax Act”) was enacted on December 22, 2017. The Tax Act reduced the U.S. federal corporate tax rate
from 35% in 2017 to 21% in 2018, required companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax
deferred, and created new taxes on certain foreign sourced earnings. For the year ended December 31, 2017, the Company remeasured its deferred tax
assets and liabilities based on the change in the federal rate to 21%. At December 31, 2018, the Company had completed its accounting for the Tax Act,
which, other than the decrease in its gross deferred tax assets, did not have a material impact on the Company’s financial statements.
Deferred Tax Assets and Liabilities
Deferred income taxes reflect the net tax effects of loss and credit carryforwards and temporary differences between the carrying amounts of
assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax
assets for federal and state income taxes are as follows (in thousands):
Deferred tax assets:
Net operating loss carryforwards
Research and development credits
Deferred revenue
Accruals
Stock-based compensation
Inventory
Operating lease liabilities
Other intangibles
Other
Total gross deferred tax assets
Less: Valuation allowance
Net deferred tax assets
Deferred tax liabilities:
Property and equipment
Operating lease right-of-use assets
Net deferred tax liabilities
As of December 31,
2019
2018
$
$
$
30,375 $
6,190
2,154
784
787
—
574
426
114
41,404
(40,000)
1,404 $
(875)
(529)
(1,404) $
22,441
4,634
4,839
460
297
42
—
458
3
33,174
(32,423)
751
(751)
—
(751)
Realization of our deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Because of our
lack of U.S. earnings history, the net U.S. deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $7.6
million and $4.5 million for the years ended December 31, 2019 and 2018, respectively.
Net Operating Loss and Tax Credit Carryforwards
As of December 31, 2019, the Company had net operating loss carryforwards for federal income tax purposes of approximately $114.9 million,
portions of which will begin to expire in 2031. The Company had a total state net operating loss carryforward of approximately $72.2 million, which will
begin to expire in 2031. Utilization of some of the federal and state net operating loss and credit carryforwards are subject to annual limitations due to the
“change in ownership” provisions of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations may result in the
expiration of net operating losses and credits before utilization.
The Company has federal credits of approximately $3.0 million, which will begin to expire in 2031 and state research credits of approximately
$3.2 million, which have no expiration date. These tax credits are subject to the same limitations discussed above.
96
Unrecognized Tax Benefits
The Company has incurred net operating losses since inception and does not have any significant unrecognized tax benefits. The Company’s
policy is to include interest and penalties related to unrecognized tax benefits, if any, within the provision for taxes in the consolidated statements of
operations. If the Company is eventually able to recognize its uncertain positions, the effective tax rate would be reduced. The Company currently has a full
valuation allowance against its net deferred tax asset, which would impact the timing of the effective tax rate benefit should any of these uncertain tax
positions be favorably settled in the future. Any adjustments to the Company’s uncertain tax positions would result in an adjustment of net operating loss or
tax credit carryforwards rather than resulting in a cash outlay.
The Company files U.S. federal income tax returns and various state income tax returns. Because of net operating losses and research credit
carryovers, substantially all of the Company’s tax years remain open to examination.
The Company has the following activity relating to unrecognized tax benefits (in thousands):
Beginning balance
Gross increase—tax provision in current period
Ending balance
As of December 31,
2019
2018
$
$
1,192 $
389
1,581 $
917
275
1,192
Although it is reasonably possible that certain unrecognized tax benefits may increase or decrease within the next 12 months due to tax
examination changes, settlement activities, expirations of statute of limitations, or the impact on recognition and measurement considerations related to the
results of published tax cases or other similar activities, the Company does not anticipate any significant changes to unrecognized tax benefits over the next
12 months. During the years ended December 31, 2019, 2018, and 2017, no significant interest or penalties were required to be recognized relating to
unrecognized tax benefits.
Note 15. Selected Quarterly Financial Information (Unaudited)
The following tables show a summary of the Company’s quarterly financial information for each of the four quarters of 2019 and 2018 (in
thousands, except per share amounts):
Revenues
Gross profit
Net loss
Basic and diluted earnings per share
Revenues
Gross profit
Net loss
Basic and diluted earnings per share
For the Three Months Ended (Unaudited)
December 31,
2019
September 30,
2019
June 30,
2019
March 31,
2019
18,154 $
6,565 $
(6,645) $
(0.21) $
17,153 $
5,629 $
(6,885) $
(0.22) $
15,825 $
5,902 $
(5,869) $
(0.89) $
14,075
3,984
(5,685)
(1.84)
For the Three Months Ended (Unaudited)
December 31,
2018
September 30,
2018
June 30,
2018
March 31,
2018
13,157 $
4,829 $
(3,555) $
(1.16) $
11,654 $
4,481 $
(3,641) $
(1.19) $
8,799 $
2,396 $
(7,315) $
(2.39) $
4,164
99
(5,375)
(1.76)
$
$
$
$
$
$
$
$
97
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Personalis, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Personalis, Inc. and subsidiary (the "Company") as of December 31, 2019 and 2018, the
related consolidated statements of operations, comprehensive loss, redeemable convertible preferred stock and stockholders' equity (deficit), and cash flows
for each of the three years in the period ended December 31, 2019, and the related notes (collectively referred to as the "financial statements"). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the
results of its operations and its cash flows for each of the three years in the period ended December 31, 2019, in conformity with accounting principles
generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over
financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and
performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in
the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ DELOITTE & TOUCHE LLP
San Jose, California
March 25, 2020
We have served as the Company's auditor since 2018.
98
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of disclosure controls and procedures
Our management, with the participation of our chief executive officer, or CEO, and chief financial officer, or CFO, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended, or Exchange Act), as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our CEO and CFO have
concluded that as of December 31, 2019, our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide
reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed,
summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such required information is accumulated and
communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosures.
Changes in internal control
During the fourth quarter of 2019, we remediated the material weaknesses in our internal control over financial reporting identified in connection
with preparation of our financial statements for the years ended December 31, 2017 and 2018. The material weakness in internal controls was due to a lack
of sufficient full-time accounting staff with requisite experience and deep technical accounting knowledge to (i) identify and resolve complex accounting
issues under U.S. GAAP and (ii) allow for appropriate segregation of duties. Remediation of the material weakness involved hiring a Chief Financial
Officer in March 2019 and four additional accounting resources in the second, third, and fourth quarters of 2019, including two Certified Public
Accountants with the specific technical accounting and financial reporting experience necessary for a public company. Management believes these
additional resources provide an appropriate remediation of the material weakness.
Management report on internal control over financial reporting
This annual report does not include a report of management's assessment regarding internal control over financial reporting due to a transition
period established by rules of the Securities and Exchange Commission for newly public companies.
In addition, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial
reporting for so long as we qualify as an “emerging growth company,” as defined under the JOBS Act.
Item 9B. Other Information.
None.
99
Item 10. Directors, Executive Officers and Corporate Governance.
PART III
The information required by this Item is set forth under the headings “Executive Officers,” “Security Ownership of Certain Beneficial Owners
and Management,” “Delinquent Section 16(a) Reports,” “Corporate Governance and Board of Directors Matters,” and “Proposal No. 1 Election of
Directors—Information About Our Continuing Directors” in the Company’s 2020 Proxy Statement to be filed with the SEC within 120 days after
December 31, 2019 in connection with the solicitation of proxies for the Company’s 2020 annual meeting of stockholders, and is incorporated herein by
reference.
Our board of directors has adopted a Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available
on our website (investors.personalis.com) under "Corporate Governance." We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K
regarding amendment to, or waiver from, a provision of our Code of Business Conduct and Ethics by posting such information on the website address and
location specified above.
Item 11. Executive Compensation.
The information required by this Item is set forth under the headings “Director Compensation,” “Executive Compensation,” and “Compensation
Committee Interlocks and Insider Participation” in the Company’s 2020 Proxy Statement to be filed with the SEC within 120 days after December 31,
2019, and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item is set forth under the headings “Equity Compensation Plans at December 31, 2019” and “Security
Ownership of Certain Beneficial Owners and Management” in the Company’s 2020 Proxy Statement to be filed with the SEC within 120 days after
December 31, 2019, and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is set forth under the headings “Corporate Governance and Board of Directors Matters” and “Transactions
with Related Persons and Indemnification” in the Company’s 2020 Proxy Statement to be filed with the SEC within 120 days after December 31, 2019, and
is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services.
The information required by this Item is set forth under the headings “Principal Accountant Fees and Services” and “Pre-Approval Procedures”
under the proposal “Ratification of Selection of Independent Registered Public Accounting Firm” in the Company’s 2020 Proxy Statement to be filed with
the SEC within 120 days after December 31, 2019, and is incorporated herein by reference.
100
Item 15. Exhibits, Financial Statement Schedules.
(a)
Financial Statements and Schedules
PART IV
The financial statements are set forth under Item 8 of this Form 10-K, as indexed below. Financial statement schedules have been omitted since
they either are not required, not applicable, or the information is otherwise included.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
101
Page
72
73
74
75
76
77
98
(b)
Exhibits
Exhibit
Number
Description
3.1
3.2
4.1
4.2
4.3
4.4
4.5
10.1#
10.2#
10.3#
10.4#
10.5#
10.6#
10.7#
10.8#
10.9
10.10¥
10.11¥
10.12¥
10.13¥
10.14¥
10.15¥
10.16¥
10.17¥
10.18¥
10.19¥
Amended and Restated Certificate of Incorporation of the Registrant.
Amended and Restated Bylaws of the Registrant.
Description of Securities of Personalis, Inc.
Form of Common Stock Certificate of the Registrant.
Amended and Restated Investor Rights Agreement by and among the
Registrant and certain of its stockholders, dated December 16, 2014.
Warrant to purchase capital stock of the Registrant, issued to TriplePoint
Capital LLC, dated September June 28, 2017.
Warrant to purchase capital stock of the Registrant, issued to TriplePoint
Capital LLC, dated September March 22, 2019.
Personalis, Inc. 2011 Equity Incentive Plan, as amended, and forms of
agreements thereunder.
Personalis, Inc. 2019 Equity Incentive Plan and forms of agreements
thereunder.
Personalis, Inc. 2019 Employee Stock Purchase Plan.
Form of Indemnification Agreement entered into by and between the
Registrant and each director and executive officer.
Employment Terms Letter, by and between John West and the Registrant,
dated June 2, 2019.
Employment Terms Letter, by and between Clinton Musil and the
Registrant, dated June 2, 2019.
Employment Terms Letter, by and between Dr. Richard Chen and the
Registrant, dated June 2, 2019.
Employment Terms Letter, by and between Aaron Tachibana and the
Registrant, dated June 2, 2019.
Lease, by and between MENLO PREHC I, LLC, MENLO PREPI I, LLC,
TPI INVESTORS 9, LLC and the Registrant, dated February 2, 2015.
Contract No. VA240-17-D-0103, by and between the U.S. Department of
Veterans Affairs and the Registrant, dated September 28, 2017.
Quotation for Supply of Genetic Analysis Products No. 4079884, by and
between Illumina, Inc. and the Registrant, dated March 21, 2017.
Purchase Order No. P11405, by and between Illumina, Inc. and the
Registrant, dated March 31, 2017.
Master Services Subcontract Agreement, by and between Illumina, Inc.
and the Registrant, dated November 1, 2017.
Pricing Agreement, by and between Illumina, Inc. and the Registrant,
dated November 22, 2017.
Fasttrack Genetic Analysis Services Agreement No. MQ-
20171213CG100, by and between Illumina, Inc. and the Registrant, dated
December 13, 2017.
Quotation for Supply of Genetic Analysis Products No. SQ-
20190214CG102, by and between Illumina, Inc. and the Registrant, dated
February 22, 2019.
Quotation for Supply of Genetic Analysis Products No. 4192031, by and
between Illumina, Inc. and the Registrant, dated March 1, 2019.
Purchase Order No. P11405, by and between Illumina, Inc. and the
Registrant, dated March 20, 2019.
Pricing Agreement, by and between Illumina, Inc. and the Registrant,
dated March 26, 2019.
102
Incorporated by Reference
Form
8-K
8-K
File No.
001-38943
001-38943
Exhibit
3.1
3.2
S-1/A
S-1
333-231703
333-231703
333-231703
333-231703
S-1
S-1
S-1
4.1
4.2
4.4
4.5
Filing Date
6/24/2019
6/24/2019
6/7/2019
5/23/2019
5/23/2019
5/23/2019
333-231703
10.1
5/23/2019
S-1/A
333-231703
10.2
6/7/2019
S-1/A
S-1/A
333-231703
333-231703
10.3
10.4
6/7/2019
6/7/2019
S-1/A
333-231703
10.5
6/7/2019
S-1/A
333-231703
10.6
6/7/2019
S-1/A
333-231703
10.7
6/7/2019
S-1/A
333-231703
10.8
6/7/2019
S-1
S-1
S-1
S-1
S-1
S-1
S-1
333-231703
10.9
5/23/2019
333-231703
10.10
5/23/2019
333-231703
10.11
5/23/2019
333-231703
10.12
5/23/2019
333-231703
10.13
5/23/2019
333-231703
10.14
5/23/2019
333-231703
10.15
5/23/2019
S-1
333-231703
10.16
5/23/2019
S-1
S-1
S-1
333-231703
10.17
5/23/2019
333-231703
10.18
5/23/2019
333-231703
10.19
5/23/2019
S-1
S-1
S-1
S-1
S-1
333-231703
10.20
5/23/2019
333-231703
10.21
5/23/2019
333-231703
333-231703
333-231703
10.22
10.23
10.24
5/23/2019
5/23/2019
5/23/2019
10.20
10.21
10.22
10.23
10.24
10.25¥
21.1
23.1
24.1
31.1
31.2
32.1†
32.2†
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
Plain English Revolving Loan and Security Agreement, by and between
TriplePoint Capital LLC and the Registrant, dated June 28, 2017.
First Amendment to Plain English Revolving Loan and Security
Agreement, by and between TriplePoint Capital LLC and the Registrant,
dated March 22, 2019.
Form of convertible promissory note of the Registrant.
Amendment No. 1 to the convertible promissory note of the Registrant.
Amendment No. 2 to the convertible promissory note of the Registrant.
Quotation for Supply of Genetic Analysis Products, by and between
Illumina, Inc. and the Registrant, dated November 19, 2019.
Subsidiaries of the Registrant as of December 31, 2019.
Consent of Independent Registered Public Accounting Firm.
Power of Attorney (included on the Signatures page of this Annual Report
on Form 10-K).
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a)
and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a)
and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section
1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section
1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Extension Calculation Linkbase Document
XBRL Taxonomy Extension Definition Linkbase Document
XBRL Taxonomy Extension Label Linkbase Document
XBRL Taxonomy Extension Presentation Linkbase Document
#
†
¥
Indicates management contract or compensatory plan or arrangement.
The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Annual Report on Form 10-K are not deemed filed with the Securities and Exchange Commission and
are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made
before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.
Portions of this exhibit (indicated by asterisks) have been omitted as the Registrant has determined that (i) the omitted information is not material and (ii) the omitted information would
likely cause competitive harm to the Registrant if publicly disclosed.
Item 16. Form 10-K Summary
None.
103
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 25, 2020
Personalis, Inc.
SIGNATURES
By:
/s/ Aaron Tachibana
Aaron Tachibana
Chief Financial Officer
(Principal Financial and Accounting Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints John West and
Aaron Tachibana, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any
amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or
cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated:
Name and Signature
/s/ John West
John West
/s/ Aaron Tachibana
Aaron Tachibana
/s/ Patrick Balthrop
Patrick Balthrop
/s/ A. Blaine Bowman
A. Blaine Bowman
/s/ Alan Colowick
Alan Colowick, M.D.
/s/ Karin Eastham
Karin Eastham
/s/ Kenneth Ludlum
Kenneth Ludlum
/s/ Jonathan MacQuitty
Jonathan MacQuitty, Ph.D.
/s/ Paul Ricci
Paul Ricci
Title
President, Chief Executive Officer and Director
(Principal Executive Officer)
Chief Financial Officer
(Principal Financial and Accounting Officer)
Director
Director
Director
Director
Director
Director
Director
104
Date
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
March 25, 2020
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES
EXCHANGE ACT OF 1934
Exhibit 4.1
Personalis, Inc. (“we,” “our,” “us,” or the “Company”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”): our common stock. The following summary of the terms of our common stock is based upon our amended and restated
certificate of incorporation and our amended and restated bylaws. This summary does not purport to be complete and is subject to, and is qualified in its
entirety by express reference to, the applicable provisions of our amended and restated certificate of incorporation, our amended and restated bylaws, and
the amended and restated investor rights agreement (the “IRA”). We encourage you to read our amended and restated certificate of incorporation, our
amended and restated bylaws, the IRA, and the applicable provisions of the Delaware General Corporation Law (the “DGCL”) for more information.
DESCRIPTION OF CAPITAL STOCK
General
Our authorized capital stock consists of 210,000,000 shares, all with a par value of $0.0001 per share, of which: 200,000,000 shares are designated as
common stock and 10,000,000 shares are designated as preferred stock.
Common Stock
Holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including the election of
directors, and do not have cumulative voting rights. Accordingly, the holders of a majority of the outstanding shares of common stock entitled to vote in
any election of directors can elect all of the directors standing for election, if they so choose, other than any directors that holders of any preferred stock we
may issue may be entitled to elect. Subject to preferences that may be applicable to any then-outstanding preferred stock, holders of common stock are
entitled to receive ratably those dividends, if any, as may be declared by the board of directors out of legally available funds. In the event of our liquidation,
dissolution, or winding up, the holders of common stock will be entitled to share ratably in the assets legally available for distribution to stockholders after
the payment of or provision for all of our debts and other liabilities, subject to the prior rights of any preferred stock then-outstanding. Holders of common
stock have no preemptive or conversion rights or other subscription rights and there are no redemption or sinking funds provisions applicable to the
common stock. All outstanding shares of common stock are duly authorized, validly issued, fully paid, and nonassessable. All authorized but unissued
shares of our common stock are available for issuance by our board of directors without any further stockholder action, except as required by the listing
standards of Nasdaq. The rights, preferences, and privileges of holders of common stock are subject to and may be adversely affected by the rights of the
holders of shares of any series of preferred stock that we may designate and issue in the future.
Preferred Stock
Our board of directors may, without further action by our stockholders, fix the rights, preferences, privileges and restrictions of up to an aggregate of
10,000,000 shares of redeemable convertible preferred stock in one or more series and authorize their issuance. These rights, preferences, and privileges
could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms, and the number of shares
constituting any series or the designation of such series, any or all of which may be greater than the rights of our common stock. The issuance of our
redeemable convertible preferred stock could adversely affect the voting power of holders of our common stock, and the likelihood that such holders will
receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring, or
preventing a change of control or other corporate action.
As of December 31, 2019, our outstanding warrants consist of a warrant to purchase 62,096 shares of common stock at an exercise price of $8.052 per
share exercisable for seven years from June 28, 2017 and a warrant to purchase 65,502 shares of common stock at an exercise price of $9.16 per share
exercisable for seven years from March 22, 2019.
Warrants
Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and Bylaws
Some provisions of Delaware law, our amended and restated certificate of incorporation, and our amended and restated bylaws contain provisions that
could make the following transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of
us by means of a proxy contest or otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more
difficult to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including
transactions which provide for payment of a premium over the market price for our shares.
These provisions, summarized below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also
designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of the increased
protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the
disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.
Stockholder Meetings
Our amended and restated bylaws provide that a special meeting of stockholders may be called only by our chairman of the board, chief executive officer
or president, or by a resolution adopted by a majority of our board of directors.
Requirements for Advance Notification of Stockholder Nominations and Proposals
Our amended and restated bylaws establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting
and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the
board of directors.
Our amended and restated certificate of incorporation and amended and restated bylaws eliminate the right of stockholders to act by written consent
without a meeting.
Elimination of Stockholder Action by Written Consent
Staggered Board
Our board of directors is divided into three classes. The directors in each class will serve for a three-year term, one class being elected each year by our
stockholders. This system of electing and removing directors may tend to discourage a third party from making a tender offer or otherwise attempting to
obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Removal of Directors
Our amended and restated certificate of incorporation provides that no member of our board of directors may be removed from office by our stockholders
except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of the total voting power of all of our
outstanding voting stock then entitled to vote in the election of directors.
Stockholders Not Entitled to Cumulative Voting
Our amended and restated certificate of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the
holders of a majority of the outstanding shares of our common stock entitled to vote in any election of directors can elect all of the directors standing for
election, if they choose, other than any directors that holders of our preferred stock may be entitled to elect.
Delaware Anti-Takeover Statute
We are subject to Section 203 of the DGCL, which prohibits persons deemed to be “interested stockholders” from engaging in a “business combination”
with a publicly held Delaware corporation for three years following the date these persons become interested stockholders unless the business combination
is, or the transaction in which the person became an interested stockholder was, approved in a prescribed manner or another prescribed exception applies.
Generally, an “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of
interested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or stock
sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with
respect to transactions not approved in advance by the board of directors.
Choice of Forum
Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of
Chancery of the State of Delaware will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:
(1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim of breach of a fiduciary duty or other wrongdoing by any of
our directors, officers, employees, or agents to us or our stockholders; (3) any action asserting a claim against us arising pursuant to any provision of the
DGCL or our certificate of incorporation or bylaws; (4) any action to interpret, apply, enforce or determine the validity of our certificate of incorporation or
bylaws; or (5) any action asserting a claim governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or
liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction. Our amended and restated certificate
of incorporation further provides that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint
asserting a cause of action arising under the Securities Act, subject to and contingent upon a final adjudication in the State of Delaware of the enforceability
of such exclusive forum provision. Our amended and restated certificate of incorporation also provides that any person or entity purchasing or otherwise
acquiring any interest in shares of our capital stock will be deemed to have notice of and to have consented to these choice of forum provisions. It is
possible that a court of law could rule that the choice of forum provisions to be contained in our amended and restated certificate of incorporation are
inapplicable or unenforceable if they are challenged in a proceeding or otherwise.
Amendment of Charter Provisions
The amendment of any of the above provisions, except for the provision making it possible for our board of directors to issue preferred stock, would
require approval by holders of at least two-thirds of the total voting power of all of our outstanding voting stock.
The provisions of Delaware law, our amended and restated certificate of incorporation, and our amended and restated bylaws could have the effect of
discouraging others from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our
common stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the
composition of our board and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders
may otherwise deem to be in their best interests.
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A.
Transfer Agent and Registrar
Our common stock is currently listed on The Nasdaq Global Market under the symbol “PSNL.”
Exchange Listing
Exhibit 10.25
[***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and
would be competitively harmful if publicly disclosed.
QUOTATION FOR SUPPLY OF GENETIC ANALYSIS PRODUCTS
Prepared by:
Illumina, Inc.
5200 Illumina Way
San Diego, CA, 92122-4616, US
Hereinafter referred to as “Illumina”
Prepared For:
Personalis
Hereinafter referred to as “ Personalis ”
Quotation Number:
[***]
Quotation Date:
Expiration Date:
Prepared by:
Phone Number:
Email:
November 19, 2019
December 31, 2020
[***]
[***]
[***]
Proposal# [***] Page 1 of 12
Proposal#
[***]
Page 2 of 12
I. CUSTOMER INFORMATION
Company or Institution Name:
Personalis
Address:
1330 Obrien Dr, Menlo Park, CA, 94025-1436.
II. PRODUCT & PRICING INFORMATION
Customer receives the following discount on the product families listed below (excludes promotionally priced consumables,
software, hardware or new instrument purchases). For the discount to apply, Customer must agree to the following:
•
•
•
•
•
•
This Master Quote, which can be used for multiple purchases, will only be valid until 5:00pm on the expiration date listed on page 1.
All Customer Purchase Orders received by Illumina that include this discounted pricing must be in the quoted currency and reference this quotation.
All discounts will be applied to Illumina's then current list price. Illumina shall at its sole discretion, adjust discount percentages for future products or for any
list price adjustments to the products offered on this Quotation.
The pricing and terms of this offer are kept confidential except as needed to execute the purchase.
Discount for consumables applies only to the product families specified in the table herein.
Customer understands that product pricing stated herein is not inclusive of any applicable shipping, freight and/or taxes. Any estimated shipping and freight
charges listed on this quotation may differ from actual charges. Any shipping/freight costs will be pre-paid and charged back to Customer. Customer
accepts responsibility for any actual incurred shipping/freight costs.
Product Family
MiSeq Sequencing Consumables
Sample Preparation Consumables
SBS and Cluster Generation Sequencing Co
Miscellaneous Sequencing Consumables
Discount%
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Discount Exception
Catalog #
20012865
20012864
20012863
20012862
20012861
20012860
20012866
20027464
20027465
20029137
20021665
Proposal#[***]Page 3 of 12
Product Description
NovaSeq 5000/6000 S1 Rgt Kit (100 cyc)
NovaSeq 5000/6000 S1 Rgt Kit (200 cyc)
NovaSeq 5000/6000 S1 Rgt Kit (300 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (100 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (200 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (300 cyc)
NovaSeq 6000 S4 Rgt Kit (300 cyc)
NovaSeq 6000 SP Reagent Kit (100 cycles)
NovaSeq 6000 SP Reagent Kit (300 cycles)
NovaSeq 6000 SP Reagent Kit (500 cycles)
NovaSeq Xp 4-Lane Kit
Discount
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Catalog #
Product Description
List Price
(USD)
Customer Price
(USD)
MiSeq Sequencing Consumables
MS-102-2003
MS-102-2002
MS-102-2001
MS-102-2023
MS-102-3001
MS-102-3003
MS-102-2022
MS-102-2021
MS-103-1001
MS-103-1002
MS-103-1003
20021681
DX-102-1001
DX-102-1004
20012865
20012864
20012863
20012862
20012861
20012860
20012866*
20027464
20027465
20029137
20021665
20014279
20014280
20015090
20015091
20015949
20015960
20015961
MiSeq® Reagent Kit v2 (500 cycle)
MiSeq® Reagent Kit v2 (300 cycle)
MiSeq® Reagent Kit v2 (50 cycle)
MSQ® RGT KT v2 (500 CYC)-20 PK
MiSeq® Reagent Kit v3 (150 cycle)
MiSeq® Reagent Kit v3 (600 cycle)
MiSeq® RGT Kit v2 (300 cycle)-20 PK
MiSeq® RGT Kit v2 (50 cycle) - 20 PK
MiSeq® Reagent Nano Kit v2 (300 Cycles)
MiSeq® Reagent Micro Kit v2 (300 Cycles)
MiSeq® Reagent Nano Kit v2 (500 Cycles)
MiSeq FGx Reagent Micro Kit
MiSEQDx CF Clinical SEQ Assay (6 Run)"
MiSeqDx CF 139 Variant Assay (2 Run)"
NovaSeq 5000/6000 Sequencing Cons
NovaSeq 5000/6000 S1 Rgt Kit (100 cyc)
NovaSeq 5000/6000 S1 Rgt Kit (200 cyc)
NovaSeq 5000/6000 S1 Rgt Kit (300 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (100 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (200 cyc)
NovaSeq 5000/6000 S2 Rgt Kit (300 cyc)
NovaSeq 6000 S4 Rgt Kit (300 cyc)
NovaSeq 6000 SP Reagent Kit (100 cycles)
NovaSeq 6000 SP Reagent Kit (300 cycles)
NovaSeq 6000 SP Reagent Kit (500 cycles)
NovaSeq Xp 4-Lane Kit
Sample Preparation Consumables
SureCell Whl Trans 3 Pr Kt (2 crtg kt )
SureCell Whl Trans 3 Pr Kt (6 crtg kt)
CRUK SMP v2 Consortia
CEU Consortia
TruSeq DNA Idx Kit Pl (96 idx,96 spl)
TruSeq DNA Idx Kit Set A (12 idx,24 spl)
TruSeq DNA Idx Kit Set B (12 idx,24 spl)
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Proposal#
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Page 4 of 12
Catalog #
Product Description
List Price
(USD)
Customer Price
(USD)
20015962
20015963
20015964
20024144
20006259
20006989
20006994
20010179
20010184
20010185
20010186
20010187
20010188
20010190
20027216
20027215
20027214
20027213
20025895
20025524
20025523
20025520
20025519
20024586
20024145
20011891
20015965
20020590
20020591
20020594
20020595
20020596
20020597
20020598
20020599
TruSeq DNA PCR-Free LT LPK (24 spl)
TruSeq DNA PCR-Free HT LPK (96 spl)
TruSeq Nano DNA LT LPK (24 spl)
ILMN Free Adptr Blkng Rgnt (12 rxns)
TruSeq Custom Amplicon Dx – FFPE QC
High Thrghpt TruSeq R Enrch DNA LPK
TruSight HLA v1 Box 4 (Post-PCR)
TruSight HLA-B Primers v2 Kit
TruSight Oncology Library Prep
TruSight Oncology DNA Library Prep
TruSight Oncology RNA Library Prep
TruSight Oncology Enrichment
TruSight Tumor 170 Content Set
TruSight HLA-DRB Primers v2 Kit
Nextera Compatible Unique Dual Idx - D
Nextera Compatible Unique Dual Idx - C
Nextera Compatible Unique Dual Idx - B
Nextera Compatible Unique Dual Idx - A
VeriSeq NIPT SMP Prep Kit (24 SMP)
Nextera DNA Flex LPK Enrich (96 Spl)
Nextera DNA Flex LPK Enrich (16 Spl)
Nextera DNA Flex LPK - Small (96 Spl)
Nextera DNA Flex LPK - Small (16 Spl)
TruSight Oncology UMI Reagents
ILMN Free Adptr Blkng Rgnt (48 rxns)
Canadian Consortia Inherited Cancer
TruSeq Nano DNA HT LPK (96 spl)
IDT-TruSeq DNA UD Idx (24 Idx, 96 Spl)
IDT-TruSeq RNA UD Idx (24 Idx, 96 Spl)
TruSeq Stranded mRNA LP (48 Spl)
TruSeq Stranded mRNA LP (96 Spl)
TruSeq Strnd Total RNA LP HMR (48 Spl)
TruSeq Strnd Total RNA LP HMR (96 Spl)
TruSeq Strnd Total RNA LP Gold (48 Spl)
TruSeq Strnd Total RNA LP Gold (96 Spl)
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Proposal#
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Page 5 of 12
Catalog #
Product Description
List Price
(USD)
Customer Price
(USD)
20020610
20020611
20020612
20020613
20020614
20020615
20020616
20020617
20021354
20021356
20022370
20022371
20023394
20023395
20015966
20015967
20015968
20015969
20015970
20015971
20018622
20018704
20018705
20018706
20018707
20018708
20019792
20020181
20020182
20020183
20020187
20020188
20020189
20020490
20020492
TruSeq Strnd Total RNA LP Plant (48 Spl)
TruSeq Strnd Total RNA LP Plant (96 Spl)
TruSeq Strnd Total RNA LP Globin(48 Spl)
TruSeq Strnd Total RNA LP Globin(96 Spl)
TruSeq Exome Kit (24 Spl)
TruSeq Exome Kit (96 Spl)
Nextera Exome Kit (24 Spl)
Nextera Exome Kit (96 Spl)
TruSeq Neuro Panel 24/48/4
TruSeq Neuro Panel 96/288/24
IDT for Illumina TruSeq DNA UD Indices
IDT for Illumina TruSeq RNA UD Indices
TruSight cfDNA UMI HiSeq 2500 Kt(48 Spl)
TruSight cfDNA UMI HiSeq 4000 Kt(48 Spl)
TruSight® Lymphoma 40 (8 SMP)
TruSight® Lymphoma 40 (48 SMP)
TruSight® ALL 52 (16 SMP)
TruSight® ALL 52 (96 SMP)
TruSight® Myeloma 43 (16 SMP)
TruSight® Myeloma 43 (96 SMP)
TruSight Tumor 170 LPK - Watson
Nextera DNA Flex LPK (24 SPl)
Nextera DNA Flex LPK (96 SPl)
Flex Lysis reagent Kit
Nextera DNA CD Idx (24 Idx, 24 SPl)
Nextera DNA CD Idx (96 Idx, 96 SPl)
TruSeq RNA CD Idx (96 Idx, 96 Spl)
TruSeq DNA LP for Enrch (24 Spl)
TruSeq DNA LP for Enrch (96 Spl)
Exome Panel (45Mb)
Nextera DNA LP for Enrch (24 Spl)
Nextera DNA LP for Enrch (96 Spl)
TruSeq RNA LP for Enrch (48 Spl)
TruSeq RNA Enrch (12 enrch)
TruSeq RNA Sgl Idx SetA (12 Idx,48 Spl)
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Proposal#
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Page 6 of 12
Catalog #
20020493
FC-131-1001
RT-402-1001
FC-132-1001
RT-401-1001
IP-202-1024
IP-202-1012
AB0007
FC-121-0202
FC-121-0205
FC-130-1010
RT-402-1002
RT-402-1003
RT-402-1004
FC-140-1101
FC-140-1102
FC-140-1103
FC-140-1104
FC-140-1105
FC-140-1106
AB0005
FC-131-1096
SA0045
SA0044
SA0043
SA0042
SA0041
SA0040
RS-200-0012
RS-200-0024
RS-200-0036
RS-200-0048
AB0019
AB0017
AB0015
Product Description
List Price
(USD)
Customer Price
(USD)
TruSeq RNA Sgl Idx SetB (12 Idx,48 Spl)
NXTR® XT IDX Kit (24 IDXS, 96 SMP)
TruSq® Trgtd RNA IDX KtA, 96 IDX 384 SMP
Nextera® Mate Pair Sample PrepKit
TruSeq® Trgtd RNA IDX Kt, 48 IDX 192 SMP
TruSeq® ChIP SMP Prep Kit 48 SMP-Set B
TruSeq® ChIP SMP Prep Kit 48 SMP-Set A
FusionPlex® CTL, for Illumina®
TruSight™ Cancer Sequencing Panel
TruSight Inherited Disease SEQ Panel"
TruSight™ Myeloid Sequencing Panel
TruSq® Trgtd RNA IDX KtB, 96 IDX 384 SMP
TruSq® Trgtd RNA IDX KtC, 96 IDX 384 SMP
TruSq® Trgtd RNA IDX KtD, 96 IDX 384 SMP
TruSite RPD CPTR KT (1INX 8 SMP)
TruSite RPD CPTR KT (2INX 8 SMP)
TruSite RPD CPTR KT (4INX 16 SMP)
TruSite RPD CPTR KT (24 INX 48 SMP)
TruSite RPD CPTR KT (24 INX 96 SMP)
TruSite RPD CPTR KT (96 INX 288 SMP)
FusionPlex® Solid Tumor, for Illumina®
NXTR® XT DNA SMP Prep Kit (96 SMP)
MBC Adapters A41-A48 for Illumina®
MBC Adapters A33-A40 for Illumina®
MBC Adapters A25-A32 for Illumina®
MBC Adapters A17-A24 for Illumina®
MBC Adapters A9-A16 for Illumina®
Archer® MBC Adapters A1-A8 for Illumina®
TruSeq® Small RNA SMP PrepKit v2set A
TruSeq® Small RNA SMP PrepKit v2 set B
TruSeq® Small RNA SMP PrepKit v2 set C
TruSeq® Small RNA SMP PrepKit v2 set D
FusionPlex® Lymphoma, for Illumina®
FusionPlex® Pan-Heme, for Illumina®
FusionPlex® Myeloid, for Illumina®
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Proposal#
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Page 7 of 12
Catalog #
AB0013
15027865
15027866
RS-122-2001
RS-122-2002
AB0011
AB0009
FC-130-1003
FC-130-1007
FC-130-1005
FC-130-1006
RS-200-1001
FC-131-1024
FC-121-9999
OP-101-1001
20029226
FC-133-1001
OP-101-1002
OP-101-1004
RH-200-1001
RH-200-1002
FC-151-1002
FC-151-1003
20028825
FC-141-2007
RS-303-1002
RS-303-1003
RS-304-1002
RS-304-1003
20028821
20000902
20000903
20028216
20028215
20028214
Product Description
List Price
(USD)
Customer Price
(USD)
FusionPlex® ALL, for Illumina®
NX#-TDE1,TGMNT DNA ENZ,24RXN,FINISH REAG
NX#-TD,TAGMENT DNA BUFFER,FINISH REAG
Kit, TruSeq RNA SMP Prep Kit-v2, 48,SetA
Kit, TruSeq RNA SMPle Prep Kit-v2
FusionPlex® Heme v2, for Illumina®
FusionPlex® Oncology Research
TruSeq® CTM AMPLCN IDXKit 96 IDX,384 SMP
TruSq® IDX PLT Fixture&Collar Kt 2 Each
TruSeq® Index Plate Fixture Kit
TruSeq CSTM Amplicon FLTRPlate 1 Plate)"
TruSeq™ RNA EPH Reagent Tube
NXTR® XT DNA SMP Prep Kit (24 SMP)
TruSeq® FFPE DNA Library PrepQC Kit
TruSight® Tumor 15 Kit
TST One Expanded - Oligos (36 Spl)
NXTR® XT LIB Prep KT PulseNet (96 SMP)
TruSight® Tumor 15
TruSight Tumor 170
VeriSeq NIPT SMP Prep Kit(48 SMP)
VeriSeq NIPT SMP Prep Kit(96 SMP)
TruSeq Methyl Capture EPIC Kit (12 smp)
TruSeq Methyl Capture EPIC Kit (48 smp)
TG TruSeq Nano DNA HT SMPPrep Kt 96 SMP
TruSight One Expanded Seq Panel (36 smp)
TruSight RNA Pan-Cancer Panel 48smp-SetA
TruSight RNA Pan-Cancer Panel 48smp-SetB
TruSight® RNA Fusion Panel 48SMP - Set A
TruSight® RNA Fusion Panel 48SMP - Set B
TruSight Tumor 170 Kit - NextSeq v2.5
SeqLab TruSeq DNA PCR-Free LibraryPrepHT
SeqLab TruSeq Nano DNA Library Prep HT
TruSight Onco 500 DNA/RNA Kt,NSQ(24 Spl)
TruSight Onco 500 DNA/RNA Kt (24 Spl)
TruSight Onco 500 DNA Kt, NSQ (48 Spl)
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Proposal#
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Page 8 of 12
Catalog #
20028213
20005170
20005718
FC-452-1001
FC-141-1006
AB0003
AB0001
20032629
20032628
20032627
20032626
20032625
20032624
FC-141-1007
FC-141-1010
FC-141-1011
20029551
20029550
FC-131-2001
FC-131-2002
FC-131-2003
FC-131-2004
20029274
FC-142-1001
FC-451-1001
20029229
20029227
FC-401-4003
FC-402-4023
FC-402-4021
FC-402-4022
GD-401-3001
PE-401-3001
FC-401-3001
Product Description
TruSight Onco 500 DNA Kt (48 Spl)
TruSight HLA v2 (24 samples Automated)
TruSeq Custom Amplicon Kit Dx
ForenSeq™ Human Sequencing Control
TruSight One SEQ Panel(9 SMPles)
FusionPlex® Sarcoma, for Illumina®
FusionPlex® Alk Ret Ros1 v2
TST170 Kit-NextSeq v2.5(24spl)+PierianDx
TST170 Kit (24 Samples)+PierianDx
TSO500 DNA/RNA Kit NextSeq (24)PierianDx
TSO500 DNA/RNA Kit (24Spl)+PierianDx
TSO500 DNA Kit NextSeq (48Spl)+PerianDx
TSO500 DNA Kit (48 samples)+PierianDx
TruSight One SEQ Panel(36 SMPles)"
TrSt-Crd-Sq-Kt(MSQ®,12 spls,v2 Ch)
TrSt-Crd-Sq-Kt(NSQ®,48 spls,Mid OTP)
TST Hereditary Cancer – oligos (48 spl)
TruSeq Neuro - oligos (48 spl)
NXTR® XT IDX Kt v2 Set A 96 IDXS,384 SMP
NXTR® XT IDX Kt v2 Set B 96 IDXS,384 SMP
NXTR® XT IDX Kt v2 Set C 96 IDXS,384 SMP
NXTR® XT IDX Kt v2 Set D 96 IDXS,384 SMP
TG Library Prep Partner Kit
TruSight HLA Seq Panel (24 smp)
ForenSeq™ Index Adapter Fixture
TST Cardio - Oligos (48 Spl)
TST One - Oligos (36 Spl)
SBS and Cluster Generation Sequencing Co
HiSeq® SBS Kit v4 (250 Cycle)
HiSeq® Rapid SBS Kit v2 (500 cycles)
HiSeq® Rapid SBS Kit v2 (200 cycles)
HiSeq® Rapid SBS Kit v2 (50 cycles)
TruSeq® SR Cluster Kit v3 – cBot™ - HS
TruSeq® PE Cluster Kit v3 – cBot™ - HS
TruSeq SBS KIT v3 - HS (200 CYCLES)
List Price
(USD)
Customer Price
(USD)
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Proposal#
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Page 9 of 12
Catalog #
FC-401-3002
FC-401-4002
PE-402-4002
GD-402-4002
GD-401-4001
20006992
20006991
PE-401-4001
15056112
15037576
DX-502-1003
FC-901-1003
FC-800-1001
PE-121-1003
FC-121-1003
FC-110-3001
GD-304-2001
SY-401-2015
GD-403-4001
20015892
20012552
20005160
15073345
GD-310-1001
MS-102-9999
GD-404-1001
CT-403-2001
FC-110-3002
Product Description
List Price
(USD)
Customer Price
(USD)
TruSeq SBS KIT v3 - HS (50 CYCLES)
HiSeq® SBS Kit v4 (50 Cycle)
HiSeq® Rapid PE Cluster Kit v2
HiSeq® Rapid SR Cluster Kit v2
HiSeq® SR Cluster Kit v4 – cBot™
High Throughput HiSeq SBS Kit (150 cyc)
High Throughput HiSeq PE Cluster Kit
HiSeq® PE Cluster Kit v4 – cBot™
HiSeq® Rapid SBS Kit - FunnelBottle Caps
HiSeq® Flowcell Gaskets 4 Pack
SBS and Cluster Generation Sequencing Co
Index Adapter Replacement Caps
KIT,BRIDGE MANIFOLD,CLUSTER STATION
TruSeq® Nano DNA Accessory Kit
TruSEQ Dual IDX SEQ PRMR Kit, Paired End
TruSEQ Dual IDX SEQ PRMR Kt, Single Read
PhiX CONTROL V3 KIT
TruSq v2 cBot Multi-PRMR Re-Hybrdztn Kt
KIT,CBOT MANIFOLD,HiSEQ
HSQ® Multi-PRMR Rehybridization Kit v4
HT1 Buffer
MiSeqDx Reagent Kit v3
cBot 2 Barcoded Strip Tubes (8 well)
Streck cell free DNA BCT (CE)
HSQ® 3k/4k cBot Multi-PRMR ReHYBRID Kit
MiSeq® Disposable Wash Tubes
HiSeq® Rapid Rehybridization Kit
HiSeq® Rapid Duo cBot™ SampleLoading Kit
NextSeq™ PhiX Control Kit
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* Fixed Price is active for this material.
Post Pricing Message: Payment Terms for the account is Net 60
III. CONDITIONS OF SALE
By submitting an order, Customer accepts and agrees that the Terms and Conditions is the sole and exclusive agreement between Customer and Illumina with
respect to the Illumina products and/or services as described above and accepts all other terms of this quotation.
NOTWITHSTANDING THE FOREGOING, IF ILLUMINA AND CUSTOMER HAVE ENTERED INTO A VALID AND ENFORCEABLE AGREEMENT GOVERNING
THE ILLUMINA PRODUCTS AND/OR SERVICES DESCRIBED ABOVE, THE ORDER OF PRECEDENCE BETWEEN THE AGREEMENT AND THE TERMS
AND CONDITIONS SHALL BE AS FOLLOWS: IN THE EVENT OF A CONFLICT
Proposal#
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BETWEEN THE TERMS OF THE AGREEMENT AND THE TERMS AND CONDITIONS, OR IF THE AGREEMENT INCLUDES ADDITIONAL TERMS NOT
ADDRESSED IN THE TERMS AND CONDITIONS, THE AGREEMENT SHALL GOVERN WITH RESPECT TO SUCH TERMS.
Illumina does not supply plastics such as microplates or pipette tips for use in the listed assays and these are not included in the consumables pricing provided;
however, as a result of the highly multiplexed nature of all assays, plastics alone contribute minimally to the final cost.
Customer and Illumina agree as follows:
•
Customer’s purchase of the products referenced in this Quotation is not conditioned on future performance characteristics or applications, whether or
not realized.
Unless otherwise agreed by Illumina in writing, Illumina will not assist Customer in developing, testing, or validating unsupported applications.
Illumina will not replace any consumables or reagent kits if the cause of any performance failure is due to unsupported applications.
Illumina is unable to provide any assurances or guarantee that the performance of the products referenced in this Quotation will match published
specifications when used for unsupported applications.
IV. SHIP HOLD
In cases where this Quotation does not include a pre-defined ship schedule, the following ship hold terms shall apply:
•
All orders must have a defined ship schedule. The initial ship date must be no later than three (3) months from the date the purchase order is received
by Illumina (as provided in the Order Confirmation) and the entire order must be shipped complete within twelve (12) months from Illumina’s receipt of
the purchase order.
Any exceptions to these ship hold terms must be agreed to in writing by Illumina and the Customer must pre-pay at least fifty percent (50%) of the
purchase order amount of the affected shipments.
Customers may request two (2) shipment delays for any single purchase order. The total months of delayed shipment for shipments associated with a
single purchase order shall not exceed six (6) months.
If Customer has requested a delayed shipment, Illumina reserves the right to change the lead time necessary to initiate Customer’s first shipment
(which may be longer than the lead time quoted at the time of the order placement).
If Customer cannot take shipment in accordance with these terms, Illumina reserves the right to cancel the order in its entirety without any liability to the
Customer.
•
•
•
•
•
•
•
V. HOW TO ORDER
RUO & DX Goods, Instruments and Warranty Coverage (including BlueGnome)
For all consumable orders:
Please submit your order online through MyIllumina
(http://my.illumina.com).
For all other orders:
Please submit your institutional Purchase Order and a complete copy of this
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VI. EXPIRATION OF OFFER
The offer contained in this document is revocable at the sole discretion of Illumina if not executed by Customer and a purchase order
received by Illumina before 5:00 pm Pacific Time on the expiration date shown on page 1 of this quotation.
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Terms and Conditions of Sale
http://www.illumina.com/content/dam/illumina-marketing/documents/terms-conditions/united-states/usa-terms-and-conditions-of-sale-
general.pdf. Additionally, if Customer is purchasing Illumina professional consulting services as relate to instruments, Customer environment
or workflows (in all cases, excluding instrument warranty services) ("Professional Services"), Customer agrees such Professional Services
are exclusively governed by the Terms and Conditions - Services (Professional Services) located here:
http://www.illumina.com/content/dam/illumina-marketing/ documents/company/terms-and-conditions-services.pdf
SUBSIDIARY OF PERSONALIS, INC.
Exhibit 21.1
Name of Subsidiary
Personalis (UK) Ltd.
Jurisdiction of Incorporation
United Kingdom
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23.1
We consent to the incorporation by reference in Registration Statement No. 333-232233 on Form S-8 of our report dated March 25, 2020, relating to the
consolidated financial statements of Personalis, Inc. and subsidiary (the “Company”), appearing in the Annual Report on Form 10-K of the Company for
the year ended December 31, 2019.
/s/ DELOITTE & TOUCHE LLP
San Jose, California
March 25, 2020
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, John West, certify that:
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Personalis, Inc.;
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;
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;
The registrant's other certifying officer 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)) for the registrant and have:
(a)
(b)
(c)
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;
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
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 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)
(b)
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
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.
Date: March 25, 2020
By: /s/ John West
John West
Chief Executive Officer
(Principal Executive Officer)
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Aaron Tachibana, certify that:
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of Personalis, Inc.;
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;
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;
The registrant's other certifying officer 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)) for the registrant and have:
(a)
(b)
(c)
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;
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
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 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)
(b)
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
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.
Date: March 25, 2020
By: /s/ Aaron Tachibana
Aaron Tachibana
Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of Personalis, Inc. (the “Company”) on Form 10-K for the period ending December 31, 2019 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the
Sarbanes-Oxley Act of 2002, that:
(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.
Date: March 25, 2020
By: /s/ John West
John West
Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of Personalis, Inc. (the “Company”) on Form 10-K for the period ending December 31, 2019 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the
Sarbanes-Oxley Act of 2002, that:
(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.
Date: March 25, 2020
By: /s/ Aaron Tachibana
Aaron Tachibana
Chief Financial Officer
(Principal Financial Officer)