2019 ANNUAL REPORT
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
☒
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: 001-37478
NATERA, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
State or Other Jurisdiction of Incorporation or Organization
01-0894487
(I.R.S. Employer Identification No.)
201 Industrial Road, Suite 410
San Carlos, CA
(Address of Principal Executive Offices)
94070
(Zip Code)
(650) 249-9090
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol
Common Stock, par value $0.0001 per share
NTRA
Name of each exchange on which registered
The Nasdaq Stock Market LLC
(NASDAQ Global Select 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 Section 15(d) of the Securities Act. Yes No
Securities registered pursuant to Section 12(g) of the Act: None
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, a 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
Accelerated filer
Smaller reporting company
Emerging growth 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 was approximately $1.55 billion based on the last
reported sale price of $27.58 per share as reported on the Nasdaq Global Select Market on June 28, 2019, the last trading day of the most recently completed second fiscal
quarter.
As of February 21, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was 78,252,351.
DOCUMENTS INCORPORATED BY REFERENCE
Information required in response to Part III of this annual report on Form 10-K is hereby incorporated by reference to portions of the Registrant’s proxy
statement for its Annual Meeting of Stockholders to be held in 2020. The proxy statement will be filed by the registrant with the Securities and Exchange Commission
within 120 days after the end of the registrant’s fiscal year ended December 31, 2019.
Natera, Inc.
FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2019
TABLE OF CONTENTS
Page
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS . . . . . . . . . . . . . . . . . . . . . . .
PART I
Item 1.
Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1A. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1B. Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 2.
Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 3.
Item 4. Mine Safety Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases
of Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 6.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations . . . . .
Item 7A. Quantitative and Qualitative Disclosures About Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 8.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure . . . . .
Item 9.
Item 9A. Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 9B. Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART III
Item 10. Directors, Executive Officers and Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 11. Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 13. Certain Relationships and Related Transactions, and Director Independence . . . . . . . . . . . . . . . . .
Item 14. Principal Accounting Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 15. Exhibits and Financial Statement Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 16. Form 10-K Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART IV
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements. The forward-looking statements are contained principally in the
sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of
Operations,” but are also contained elsewhere in this report. Forward-looking statements include information concerning
our future results of operations and financial position, strategy and plans, and our expectations for future operations.
Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by
terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan,"
"potential," "predict," "seek," "should," "would" or the negative version of these words and similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause
our actual results, performance or achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements, including those described in "Risk Factors" and
elsewhere in this report. Given these uncertainties, you should not place undue reliance on these forward-looking
statements. Also, forward-looking statements represent our beliefs and assumptions only as of the date of this report. In
light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a
representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time
frame, or at all. You should read this report completely and with the understanding that our actual future results may be
materially different from what we expect.
These forward-looking statements include, but are not limited to, statements concerning the following:
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our expectation that, for the foreseeable future, a significant portion of our revenues will be derived from
sales of Panorama and Horizon;
our ability to increase demand for Panorama and Horizon, obtain favorable coverage and reimbursement
determinations from third-party payers, and expand geographically;
our expectation that Panorama will be adopted for broader use in average-risk pregnancies and for the
screening of microdeletions and that third-party payer reimbursement will be available for these
applications;
our expectations of the reliability, accuracy, and performance of our tests, as well as expectations of the
benefits of our tests to patients, providers, and payers;
our ability to successfully develop additional revenue opportunities and expand our product offerings to
include new tests;
our efforts to successfully develop and commercialize our technology and expertise in reproductive health
into oncology and transplant rejection applications;
the effect of improvements in our cost of goods sold;
our estimates of the total addressable markets for our current and potential product offerings;
our ability and expectations regarding obtaining, maintaining and expanding third-party payer coverage of,
and reimbursement for, our tests;
the effect of changes in the way we account for our revenue;
our ability to successfully commercialize our products through strategic or commercial partnerships, such
as our agreements with BGI Genomics Co., Ltd. and Foundation Medicine, Inc., and our ability to enter
into additional partnerships in the future;
the scope of protection we establish and maintain for, and developments or disputes concerning, our
intellectual property or other proprietary rights;
our ability to successfully compete in the markets we serve;
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our reliance on collaborators such as medical institutions, contract laboratories, laboratory partners, and
other third parties;
our ability to operate our laboratory facility and meet expected demand, and to successfully scale our
operations;
our reliance on a limited number of suppliers, including sole source suppliers, which may impact our
ability to maintain a continued supply of laboratory instruments and materials and to run our tests;
our expectations of the rate of adoption of Panorama, Horizon and of any of our other current or future tests
by laboratories, clinics, clinicians, payers, and patients;
our ability to complete clinical studies and publish clinical data in peer-reviewed medical publications
regarding Panorama and any of our future tests, including our SMART study and our ongoing and planned
trials in oncology and transplant rejection;
our reliance on our partners to market and offer our tests in the United States and in international markets;
our estimates regarding our costs and risks associated with our international operations and international
expansion;
our ability to retain and recruit key personnel;
our reliance on our direct sales efforts;
our expectations regarding acquisitions and strategic operations;
our ability to fund our working capital requirements;
our compliance with federal, state, and foreign regulatory requirements;
the factors that may impact our financial results; and
anticipated trends and challenges in our business and the markets in which we operate.
Any forward-looking statement made by us in this report speaks only as of the date on which it is made. Except
as required by law, we disclaim any obligation to update these forward-looking statements publicly, or to update the
reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new
information becomes available in the future.
As used in this annual report on Form 10-K, the terms “Natera,” “Registrant,” “Company,” “we,” “us,” and “our”
mean Natera, Inc. and its subsidiaries unless the context indicates otherwise.
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Item 1.
BUSINESS
Note: A glossary of terms used in this Form 10-K appears at the end of this Item 1.
PART I
Overview
We are a diagnostics company with proprietary molecular and bioinformatics technology that we are deploying
to change the management of disease worldwide. Our novel molecular assays reliably measure many informative regions
across the genome from samples as small as a single cell. Our statistical algorithms combine these measurements with data
available from the broader scientific community to identify genetic variations covering a wide range of serious conditions
with best-in-class accuracy and coverage. Our technology has been proven clinically and commercially in the reproductive
health space, in which we develop and commercialize non- or minimally- invasive tests to evaluate risk for, and thereby
enable early detection of, a wide range of genetic conditions, such as Down syndrome. We are now translating our success
in reproductive health and applying our core technology to the oncology market, in which we are commercializing a blood-
based DNA test to detect residual disease and monitor disease progression and treatment response, as well as to the organ
transplant market, with a test to assess kidney transplants for rejection. We seek to enable even wider adoption of our
technology through our global cloud-based distribution model. In addition to our direct sales force in the United States,
we have a global network of over 100 laboratory and distribution partners, including many of the largest international
laboratories.
Since 2009, we have launched a comprehensive suite of ten products in reproductive health, as well as our
personalized molecular monitoring test for use in oncology and our transplant rejection test. We intend to continue to
launch new products in the future.
We launched Panorama, our non-invasive prenatal test, or NIPT, in March 2013 and have since gone from being
the fourth company to enter the NIPT market to being the market leader by volume in the United States. We launched our
Horizon carrier screening test in 2012. Panorama and Horizon together represent the significant majority of our revenues.
Our revenues were $302.3 million in 2019 compared to $257.7 million in 2018 and $209.6 million in 2017, as revised
under Accounting Standards Codification Topic 606, or ASC 606. Our revenues are primarily generated from testing in
reproductive health, and were $269.9 million, $240.4 million and $203.8 million for the years ended December 31, 2019,
2018 and 2017, respectively. Our net losses decreased to $124.8 million in 2019 from $128.2 million in 2018, which in
turn decreased from $137.6 million in 2017.
In reproductive health, oncology and transplant rejection, the use of blood-based tests offers significant
advantages over older methods, but the significant technological challenge is that such testing requires the measurement
of very small amounts of relevant genetic material circulating – fetal DNA in reproductive health, tumor DNA in oncology,
and donor DNA in transplant rejection – within a much larger blood sample. Our approach combines proprietary molecular
biology and computational techniques to measure genomic variations in tiny amounts of DNA, as small as a single cell.
Our molecular biology techniques are based on measuring thousands of single nucleotide polymorphisms, or SNPs,
simultaneously using massively multiplexed polymerase chain reaction, or mmPCR, to multiplex, or target, many
thousands of regions of the genome simultaneously in a single test reaction. Our method avoids losing molecules, which
can happen when samples are split into separate reaction tubes, so that all relevant variants can be detected. We believe
our approach represents a fundamental advance in molecular biology. In reproductive health, this approach is distinct from
the approach employed with other commercially available NIPTs, which use first-generation “quantitative”, or counting,
methods to compare the relative number of sequence reads from a chromosome of interest to a reference chromosome.
Based on extensive data published in the journals Obstetrics & Gynecology, American Journal of Obstetrics & Gynecology,
Prenatal Diagnosis, and others, we believe Panorama is the most accurate NIPT commercially available in the United
States. In oncology, our assay has demonstrated the ability to detect circulating tumor DNA, or ctDNA, with a high degree
of sensitivity and specificity, and we believe is the only ctDNA test that is custom designed for, informed by and specific
5
to, the tumor DNA for each patient. In transplant rejection, published studies of our test performance in both clinical and
analytical validation report higher sensitivity and higher area under the curve, or AUC, than both the current standard of
care and the current commercially available test. The current standard of care in transplant rejection detection uses
functional impairment assessed by serum creatinine or estimated glomerular filtration rate, or eGFR, which are clinically
accepted but potentially inaccurate approaches for assessing active transplant rejection.
Our Solution
Genetic inheritance is conveyed through DNA, a naturally occurring information storage system. DNA stores
information in a linear sequence of the chemical bases adenine, cytosine, guanine and thymine, represented by the symbols
A, C, G, and T. Billions of bases of A, C, G, and T link together inside living cells to form the genome, which can be read
like a code or a molecular blueprint for life. While differences in the specific sequence and structure of this code drive
biological diversity, certain variations can also cause disease. Examples of genetic diversity include CNVs and SNVs. A
CNV is a genetic mutation in which relatively large regions of the genome have been deleted or duplicated, and an SNV
is a mutation where a single base has changed. When single base changes are common in the population, that position on
the chromosome, or loci, is called a single nucleotide polymorphism, or SNP.
To make sense of this deep and rich set of biological data and deliver a test result, we have developed
computationally intensive algorithms that combine the data generated by mmPCR with the ever-expanding set of publicly
available data on genetic variations. Our technology is compatible with standard equipment used globally and a range of
next generation sequencing, or NGS, platforms, and we have optimized our algorithms to enable laboratories around the
world to run tests locally and access our algorithms in the cloud using our Constellation platform.
We believe that our mmPCR technology and proprietary algorithms, which have been proven in the context of
NIPT, can be a powerful tool for applications in oncology and in organ transplant rejection. In oncology, we believe that
our ability to interrogate DNA at tens of thousands of loci in parallel in a single reaction, at the scale of a single molecule,
is well suited to the analysis of cancer-associated genetic mutations in ctDNA, in which many loci must be interrogated
simultaneously without splitting a sample, and in which it is important to achieve sensitivity to tiny amounts of tumor
DNA as low as a single copy. We are initially focused on detecting molecular residual disease, which we refer to as MRD,
and recurrence monitoring in solid tumors, where we have generated data in over a dozen different cancer types and have
published data in lung, bladder, colorectal and breast cancer. Molecular residual disease is the presence of small traces of
cancer in the blood, such as ctDNA or microscopic pieces of tumor DNA that are often undetectable with standard imaging
techniques. If left untreated, residual cancer cells can multiply and cause recurrence. Based on our internal estimates, we
believe that the total addressable market in the United States for recurrence and treatment monitoring for solid tumor
cancers is over $15 billion.
In transplant rejection, we have demonstrated the ability of our technology to measure the fraction of cell-free
DNA that is donor-derived, or dd-cfDNA, which is DNA that is shed from a transplanted organ into circulation. We are
working to commercialize Prospera, our CLIA test based on this technology. Prospera has been validated for assessment
of active rejection in kidney transplant recipients, with test performance independent of donor type, rejection type, and
clinical presentation. Based on our internal estimates, we believe the total addressable market in the United States for tests
such as ours that assess kidney transplant rejection is over $2 billion.
Our Technology
Our technologies allow us to achieve a high signal-to-noise ratio when detecting fragments of DNA at frequencies
as low as a single copy, which allows us to deliver tests with differentiated specificity and sensitivity. Furthermore, our
current reproductive health commercial tests assess the risk of a broad range of conditions, which we refer to as “clinical
coverage,” including common fetal aneuploidies, microdeletions, triploidy, and inherited genetic conditions that could be
passed on from parent to child, from a single blood draw. We sell our tests directly and partner with other clinical
laboratories to distribute our tests globally. Currently, all of our products other than our Constellation cloud software
product are laboratory developed tests, or LDTs. We perform commercial testing in our CLIA-certified laboratory.
6
An illustration of the resolution that can be achieved with our mmPCR capability is provided below. The figures
display data from our approximately 20,000 primer mmPCR assay, where each primer targets one SNP. On the left, the
assay is applied to a large genomic DNA sample from a child. On the right, the assay is applied to a single cell from the
same child. Each dot represents data from a particular SNP location on a chromosome. The assay measures the amount of
each of the two possible sequences of nucleotides, or alleles, at each SNP. The plots below show the relative proportion
of the two alleles, plotted along the vertical axis, for each of the approximately 20,000 SNPs, arranged sequentially along
the vertical axis. The two alleles are arbitrarily labeled A and B, and each dot is colored according to the allelic contribution
of the mother—red (A) or blue (B). Those SNPs where both copies of DNA in the child contain only the A allele are red
and are found at the very top of the plot, and those SNPs where both copies of DNA in the child contain only the B allele
are blue and are found at the very bottom of the plot. The SNPs where the fetus contains at least one copy of the A allele
and one copy of the B allele are found near the center of the plot. The four vertical bars separated by dotted lines display
data from chromosomes 13, 18, 21 and X. For chromosomes 13, 18 and X, the middle band is centered on 0.5; which
indicates that for those SNPs, the child has one copy of the A allele and one copy of a B allele (and therefore a relative
proportion of 0.5), and, therefore, has the right number of chromosomes—two. In this sample, an additional chromosome
is present at chromosome 21, which indicates the presence of trisomy 21. For chromosome 21, the bands centered at 0.33
and 0.66 signal the additional nucleotides contributed by the mother. The band centered at 0.33 represents SNPs where the
child has two copies of the B allele and one copy of the A allele, and the band centered at 0.66 represents SNPs where the
child has two copies of the A allele and one copy of the B allele. The assay clearly quantifies the difference between single
molecules of a particular allele at each SNP. The images demonstrate our ability to derive actionable information from
tiny quantities of DNA, as the data from a single cell in the image on the right is nearly as informative as the data from a
large genomic sample in the image on the left.
Our bioinformatics technology complements our molecular technology to deliver a risk assessment with high
sensitivity and specificity. We use proprietary statistical techniques to combine the measurements of our molecular assays
with our internal databases and the vast and growing sources of publicly available genomic information to build highly
detailed models of the genome of interest. This process includes the use of a statistical technique known as maximum
likelihood estimation, or MLE, which is widely used in other industries, such as in the conversion of a noisy transmitted
analog communications signal to a digital format. However, it is computationally complex to leverage this technique to
combine genomic information from the patient's sample and information from the databases of the broader scientific
community. We have issued U.S. patents claiming methods to do so and pending applications in the United States and
abroad. We also maintain trade secrets on our processes and practices. Our proprietary solution using MLE enables us to
continuously improve the performance of our existing tests and efficiently develop new ones. As our patient volumes grow,
our internal database of samples with genetic mutations and corresponding clinical outcomes further enhances our ability
to interpret the clinical significance of complex genetic mutations. As the genomic data from the scientific community,
such as from the Cosmic Database and the Cancer Genome Atlas, becomes richer, we can seamlessly integrate new clinical
knowledge into our bioinformatics algorithm, driving further improvement in our tests.
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Panorama
We launched our Panorama NIPT in 2013, our microdeletions panel for Panorama in 2014 and our twins, egg
donor, and surrogate screening capabilities in 2017. Panorama demonstrates the capabilities of our technology by
employing our fundamentally unique approach of simultaneously measuring thousands of SNPs in a single test reaction to
identify genetic variations in fetal DNA with a high degree of specificity and sensitivity.
Panorama helps physicians assess the risk of fetal genetic abnormalities by non-invasively screening for fetal
chromosomal abnormalities, including Down syndrome, Edwards syndrome, Patau syndrome, Turner syndrome and
triploidy, which often result in intellectual disability, severe organ abnormalities and miscarriage. Panorama can also
identify fetal sex for single birth pregnancies as well as of each fetus in twin pregnancies. Panorama is also the only
commercially available NIPT that can determine whether a set of twins is identical, or monozygotic, or fraternal, or
dizygotic. Identifying a monozygotic twin pregnancy can prompt earlier, targeted ultrasound assessments for chorionicity
and associated complications, while knowing that a twin pregnancy is dizygotic reduces concerns about certain
complications, such as twin-twin transfusion syndrome.
Panorama is performed on a maternal blood sample and can be performed as early as nine weeks into a pregnancy,
which is significantly earlier than traditional methods, such as serum protein measurement whereby doctors measure the
presence and amount of certain hormones in the blood. Panorama starts with a simple blood draw from the mother, either
in a doctor’s office, in a laboratory or through a phlebotomist that may travel to the patient, and the sample is sent to our
CLIA-certified and CAP-accredited laboratory in California. We extract DNA from each sample, amplify the specific
SNPs that we are interested in measuring, and then sequence the DNA using NGS. Using our proprietary bioinformatics
technology, we analyze the DNA sequences to assess the state of the fetal genome, focusing on the SNP data, while
incorporating public information from the Human Genome Project. Our bioinformatics algorithm builds billions of
detailed models of the potential genetic state of the sample to determine the most likely diagnosis. After Panorama
generates its result, we provide the doctor or the laboratory with a simple report showing the risk that abnormalities are
present in the fetus.
The analytic and clinical validity of our technology demonstrated in NIPT has been described in more peer-
reviewed publications covering more patients than our competitors, including in the journals Clinical Embryology,
Translational Oncology, Human Reproduction, Molecular Human Reproduction, Fertility and Sterility, PLOS ONE,
Genetics in Medicine, Prenatal Diagnosis, Fetal Diagnosis and Therapy, Obstetrics & Gynecology, Genome Medicine,
and American Journal of Obstetrics & Gynecology. Based on data published in Prenatal Diagnosis, Fetal Diagnosis and
Therapy and Obstetrics & Gynecology, Panorama demonstrated greater than 99% overall sensitivity for aneuploidies on
chromosomes 13, 18 and 21 and triploidy and specificity of greater than 99.9% (less than 0.1% false positive rate) for each
disorder, which we believe makes it overall the most accurate NIPT commercially available in the United States. A paper
published in the August 2014 issue of Obstetrics & Gynecology reported that Panorama had a statistically significant lower
false positive rate than other NIPT methods practiced by our U.S. competitors. Based on data published in Obstetrics &
Gynecology, Prenatal Diagnosis, and American Journal of Obstetrics & Gynecology, we have also demonstrated the
ability to identify fetal sex more accurately than competing NIPTs. This is partially a result of Panorama's unique ability
to detect a vanishing twin, which is a known driver of fetal sex errors with quantitative methods used by our competitors.
The October 2014 issue of the American Journal of Obstetrics & Gynecology noted that the ability of Panorama to identify
additional fetal haplotypes is expected to result in fewer false positive calls and prevent incorrect fetal sex calls. A study
reporting on the use of Panorama in over 30,000 women, published in the American Journal of Obstetrics & Gynecology,
supported the use of NIPT as a first-line screening test for aneuploidy.
We believe Panorama's specificity and sensitivity can give patients and their physicians a greater degree of
comfort in choosing to forego unnecessary invasive procedures, limiting the resulting risk of spontaneous miscarriage
associated with invasive procedures and lowering the total cost to the healthcare system of these procedures.
Panorama screens for common genetic conditions that affect both high-risk pregnancies, where maternal age is
over 35 and which we estimate represent approximately 20% of the over 6 million pregnancies in the United States, or
over 1.2 million pregnancies, and average-risk pregnancies, which we estimate represent approximately 4.9 million
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pregnancies in the United States. By recognizing early on the importance of NIPT to average-risk pregnancies and
maintaining a focus on this market, we are strategically positioned to capitalize on what we believe will be increased
penetration and reimbursement of NIPT in all risk categories. NIPT has not historically been well reimbursed for the
average-risk population; however, commercial payers representing close to half of all commercial covered lives in the
United States now have a positive coverage determination for NIPT for average-risk pregnancies, and we believe that this
momentum will continue consistent with the growing consensus among physicians, professional societies, and third-party
payers that NIPT is an appropriate screening tool for all pregnant women. ACMG is the most recent professional society
that has advocated for broader adoption of NIPT, including recommending informing pregnant women that NIPT is the
most sensitive screening option for Patau, Edwards and Down syndromes, as well as of the availability of the expanded
use of NIPT to screen for clinically relevant CNVs in the context of counseling that includes the risks/benefits and
limitations of screening for CNVs. Furthermore, we believe that data from our DNAFirst study, showing that NIPT can
be effectively and appropriately offered as a primary screen for all pregnant women regardless of risk due to maternal age
or other factors, can help to drive further progress in average-risk NIPT reimbursement. These results were published in
January 2017 in Genetics in Medicine. As part of this trial, we ran the Panorama test on over 2,600 pregnant women
through Women and Infants Hospital in Rhode Island. DNAFirst was the first study demonstrating routine clinical use of
cfDNA-based prenatal screening for common aneuploidies in a general U.S. population, offered through primary obstetric
care providers.
Our Panorama microdeletions panel screens for five of the most common genetic diseases caused by
microdeletions – 22q11.2 deletion syndrome (DiGeorge syndrome), 1p36 deletion, Angelman syndrome, Cri-du-chat
syndrome and Prader-Willi syndrome. Microdeletions are missing sub-chromosomal pieces of DNA, and can have serious
health implications depending on the location of the deletion. Unlike Down syndrome, where the risk increases with
maternal age, the risk of these five microdeletions is independent of maternal age. Based on data published in Prenatal
Diagnosis and American Journal of Obstetrics & Gynecology, the combined prevalence of these targeted microdeletions
is approximately one in 1,000 pregnancies, which collectively makes them more common than Down syndrome for women
younger than approximately 28 years of age. Diseases caused by microdeletions are often not detected via common
screening techniques such as ultrasound or hormone-based screening, yet the presence of a microdeletion can critically
impact postnatal treatment. For example, when learning prior to birth that a newborn has 22q11.2 deletion syndrome,
doctors will know to monitor the infant and administer calcium if needed to avoid seizures and permanent cognitive
impairment, and will know to avoid administering routine vaccinations due to the immunodeficiency frequently associated
with this condition.
Panorama has demonstrated best-in-class performance in screening for microdeletions. Panorama achieved
sensitivity of 90% for deletions of approximately 2.9Mb for 22q11.2 deletion syndrome, based on a validation study that
contained 10 positives. It has also been validated to perform at low fetal fractions, which refers to the percentage of fetal
DNA in a maternal plasma sample. Based on data published in the February 2018 issue of Clinical Genetics, Panorama
demonstrated a PPV of 44.2% and false positive rate of 0.07% for 22q11.2 deletion syndrome. Furthermore, we expect to
publish the results of our 20,000-patient SNP-based Microdeletions and Aneuploidy RegisTry (SMART) observational
study to evaluate the performance of SNP-based NIPT for 22q11.2 deletion syndrome by tracking birth outcomes in the
general population among women who present clinically and elect Panorama microdeletion and aneuploidy screening as
part of their routine care. In conducting this study, we reviewed perinatal medical records and collected postnatal DNA in
order to perform genetic diagnostic testing for 22q11.2 deletion syndrome, comparing results from the follow-up
specimens to those obtained by the Panorama screening test to determine test performance, particularly PPV.
The graph below summarizes the incidence of genetic diseases for which prenatal screening is relatively common,
as well as the incidence of genetic diseases caused by microdeletions that are screened by the Panorama microdeletions
panel. Incidence rates are higher than that of many commonly tested disorders, such as Cystic Fibrosis and Spinal Muscular
Atrophy. We estimate that triploidy and the aneuploidy and microdeletion conditions that we screen for combined are
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more than three times as prevalent in the general population as the three most common autosomal aneuploidies, trisomies
13 (Patau syndrome), 18 (Edwards syndrome), and 21 (Down syndrome), alone.
1. Hall. Panorama TM Non-invasive Prenatal Screening for Microdeletion Syndromes. 2013.
2. Gross, et al. Clinical experience with single-nucleotide polymorphism-based non-invasive prenatal screening for
22q11.2 deletion syndrome. Ultrasound Ob Gyn, 2016.
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The graph below demonstrates how the relative incidence of Down syndrome and genetic diseases caused by the
microdeletions screened for by the Panorama microdeletions panel varies with maternal age.
Prevalence: Incidence Does Not
Change with Age3
Incidence at Birth
1/500
Panorama Microdeletions Panel1, 3
1/1000
1/1500
Down Syndrome2
1/2000
20 22 24 26 28 30
Maternal Age
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1 Grati, et al. Prevalence of recurrent pathogenic microdeletions and microduplications in
over 9,500 pregnancies. Prenatal Diagnosis. 2015.
2 Snijders, et al. Maternal age and gestational age-specific risk for chromosomal defects.
Fetal Design Ther. 1995.
3 Hall, PanoramaTM Non-Invasive Prenatal Screening for Microdeletion Syndromes. 2013.
Because the microdeletions that we screen for are more common at birth than fetal aneuploidies for children born
to younger women, and based on the performance of Panorama on microdeletions, we believe our microdeletions testing
capability is a significant driver of Panorama adoption in all risk categories, including those who are traditionally
considered average-risk. We intend to continue to work closely with physicians, medical societies, payers, patient
advocacy groups such as the International 22q11.2 Deletion Syndrome Foundation, Inc., and our laboratory partners to
demonstrate that Panorama's sensitivity and specificity across a range of chromosomal abnormalities and superior false
positive rates, coupled with disease coverage for conditions for which prevalence does not vary with maternal age,
represent a compelling case for a continued shift towards broad adoption in the average-risk population.
Furthermore, we believe that we are well-positioned for what we anticipate will be stable reimbursement for
NIPT for microdeletions over the long term. A CPT code for use in billing and reimbursement for microdeletions testing
went into effect in January 2017, and CMS provided a pricing benchmark for aneuploidy and microdeletions testing. See
“—Reimbursement.” Since there are some Medicaid programs that haven't yet priced aneuploidy testing, we expect the
pricing of aneuploidy testing set by CMS will further increase the number of Medicaid programs that price the test and
may result in Medicaid plans pricing microdeletions testing at a faster pace. In addition, although most commercial
insurances have already priced aneuploidy testing, the price established by CMS for microdeletions testing can serve as a
relevant benchmark for pricing discussions with commercial insurance plans to begin reimbursement for microdeletions
testing. Our microdeletions reimbursement has been, and we expect that it will, at least in the near term, remain low under
the CPT code, either due to reduced reimbursement or third-party payers declining to reimburse under the code; however,
we believe that growing recognition from professional societies, combined with the performance of our microdeletions
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test and the additional validation data from our SMART study that we expect to report on the sensitivity and specificity of
our tests, will drive broader reimbursement in the future.
Panorama is also validated to screen twin pregnancies, as well as egg donor and surrogate pregnancies. Our unique
SNP technology makes Panorama the only commercially available NIPT that can distinguish between each twin’s DNA,
and therefore can determine zygosity, or whether the twins are identical or fraternal, and the fetal sex of each twin.
Determining zygosity early in a pregnancy can help guide the management of a pregnancy, as certain monozygotic, or
identical twin, pregnancies are at higher risk for various complications such as twin-twin transfusion syndrome, where
there is an unequal sharing of blood, and therefore unequal growth, between the twins. Panorama screens twin pregnancies
for Down, Edwards and Patau syndromes and, for identical twins, Turner syndrome and 22q11.2 deletion syndrome,
among others. In validation studies, Panorama identified identical twins with >99% sensitivity and specificity and achieved
a combined sensitivity of >99% and specificity of >99% for Down, Edwards and Patau syndromes in twin pregnancies.
Since launching Panorama, we have implemented various updates to both the molecular and computational
portions of Panorama, continuing to improve performance and efficiency, and reduce the cost of running the test, for
example by incorporating screening for 22q11.2 deletion syndrome in our base Panorama panel. Previous updates have
significantly reduced Panorama’s no-call rate, improved sensitivity at lower fetal fractions, and simplified sample
collection for clinics, and we’ve improved our microdeletions testing protocol to increase PPVs and reduce false positive
rates. In validation studies, Panorama has demonstrated greater than 99% sensitivity and specificity for Down syndrome,
and a combined sensitivity and specificity of greater than 99% across Down, Edwards, Patau and Turner syndromes.
Furthermore, Panorama continues to maintain the highest commercially available sensitivity (90%) for deletions of
approximately 2.9Mb for 22q11.2 deletion syndrome, based on a validation study that contained 10 positives.
Panorama's commercial performance has been consistent with our initial validation data. Data published in the
Journal of Clinical Medicine on 1,035,844 commercial cases of Panorama that were screened for Down, Edwards, Patau
and Turner syndromes demonstrated an overall PPV of 90% for all indications combined. We believe Panorama's
performance in commercial practice represents a significant improvement over first-generation NIPTs that rely on
quantitative methods. Because Panorama does not require a reference chromosome, it is uniquely able to detect triploidy
as well as full molar pregnancies. Panorama’s ability to differentiate between maternal and fetal DNA also allows
Panorama to identify the presence of a vanishing twin, as well as maternal abnormalities, which have been shown in
multiple studies to lead to false positives when using quantitative methods, particularly in the sex chromosomes where
maternal abnormalities are common.
Panorama has demonstrated substantial commercial success to date. We believe our test performance has allowed
us to command a price premium compared to low-cost NIPTs while continuing to maintain growth in volume and revenue
from Panorama.
Horizon
We launched our Horizon carrier screening test in 2012. Horizon helps couples determine if they are carriers of
genetic mutations that cause specific diseases. Depending on the specific disease, if one or both parents are carriers for a
specific disease, it could result in a child affected with the disease. Many people do not know they are a carrier for an
inherited genetic disease until they have an affected child. These diseases are rare and usually there is no family history,
although certain disorders are more common in certain ethnic groups. However, ethnicity may no longer be a reliable
predictor of carrier status, as patients are increasingly of mixed or uncertain ethnicities. Accordingly, the industry’s
approach to carrier screening has evolved over time, from ethnic-based screening targeting specific ethnicities with a
higher incidence of screened conditions, to pan-ethnic screening for certain recommended conditions available to all
patients, and most recently to expanded screening for many conditions simultaneously. In early 2017, ACOG expanded
its guidelines on carrier screening, recommending universal screening for Spinal Muscular Atrophy in addition to Cystic
Fibrosis, as many genetic conditions are not limited to any specific ethnic group, and providing guidance on expanded
carrier screening. ACOG also recommends preconception carrier screening, along with counseling, which enables couples
to learn about their reproductive risk and consider the most complete range of reproductive options.
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Horizon was created based on recommended screening guidelines from ACOG, ACMG, and the Victor Center
for the Prevention of Jewish Genetic Diseases. Horizon screens for up to 274 inherited diseases, including Cystic Fibrosis,
Duchenne Muscular Dystrophy, or DMD, Spinal Muscular Atrophy, Fragile X Syndrome and other conditions. Most
conditions on the Horizon panel are autosomal recessive disorders, which means that both parents must be carriers for
their children to be at risk. Some conditions are X-linked disorders, which are inherited from a mother who is a carrier and
primarily affect male children. If both partners are carriers for the same recessive genetic disease, the couple has a 25%
chance of having an affected child in each pregnancy. If a woman is a carrier of an X-linked disease, she has a 50% chance
of having an affected child in each pregnancy. DMD, an X-linked condition, affects approximately 1/3500 male births, an
incidence similar to Cystic Fibrosis and to Fragile X Syndrome in males. DMD is the most common muscular dystrophy
in children and affects families of all ethnicities. Approximately 2/3 of clinically diagnosed cases of DMD are attributable
to a carrier mother, who is likely unaware that she is a carrier. In addition to providing information about reproductive
risks, carrier screening can identify women who are, themselves, at risk of health effects caused by defects in the DMD
gene.
The blood or saliva sample required for Horizon can be obtained simultaneously with the blood sample required
for Panorama, which makes it easier for us to offer, and for patients to take, both tests. Horizon employs various
methodologies, including next generation sequencing and copy number analysis, often in combination in order to increase
test sensitivity, to analyze the DNA from the individual’s blood or saliva sample to determine if the individual is a carrier
for the genetic diseases being screened. Horizon test results are generally returned to the ordering physician in ten to 15
business days from the day we receive the sample, depending on the number of conditions the patient has requested to be
screened.
Vistara
We launched Vistara, an NIPT that screens for 25 single-gene disorders across 30 genes, in 2017. Vistara is a
complement to Panorama, and screens for severe skeletal, cardiac and neurological conditions which affect quality of life,
are often associated with cognitive disabilities and may benefit from medical and/or surgical intervention. The conditions
screened by Vistara have a combined incidence of approximately 1 in 600, which is higher than that of Down syndrome
as well as Cystic Fibrosis, and are associated with advanced paternal age. Other NIPTs do not screen for these conditions,
and prenatal ultrasounds may either fail to detect these disorders or the disorders may not present until much later in the
pregnancy, after birth or even into childhood. Furthermore, family history is not a good indicator of risk for these conditions,
which are commonly caused by de novo, or new and not inherited, mutations. Screening for these conditions early in the
pregnancy can facilitate early diagnosis, enable patients to be referred to MFMs and other specialists for targeted
evaluations, to guide labor and delivery management, and to allow families to mobilize resources, ask questions and
anticipate future needs. We have received a CE Mark for Vistara from the European Commission.
In validation studies, Vistara demonstrated a combined analytical sensitivity and analytical specificity of greater
than 99%.
Other reproductive health products
Spectrum comprises our preimplantation genetic tests for couples undergoing IVF. Spectrum can improve the
chance of a successful pregnancy while reducing the chance of miscarriage or of having a child with a chromosome
condition, by helping to identify the healthiest embryos during an IVF cycle. Spectrum PGT-A evaluates the number of
chromosomes in embryos to detect extra or missing pieces of chromosomes prior to transfer of embryos created through
IVF procedures, which have a high rate of non-viable chromosomal abnormalities, known as aneuploidy. Couples that are
at risk of having a child with an inherited genetic disorder can also be tested for single gene conditions (PGT-M), which
predicts which embryos are affected with specific genetic disorders; and PGT-SR can be used to test for inherited
translocations or inversions, or extra or missing chromosome pieces. This allows IVF physicians to select and transfer
chromosomally normal embryos. In particular, aneuploidy is common in human embryos—particularly as women age—
and is the primary cause of failed IVF. PGT-A has been shown to improve IVF outcomes for all women, regardless of
maternal age. In a study published in April 2018, a retrospective analysis of pregnancy outcomes demonstrated that use of
Spectrum during IVF led to increased rates of implantation, including in older women, clinical pregnancy, and live births.
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The study findings also demonstrated that use of PGT-A can increase the use of single embryo transfer, which can reduce
the risks of multiple pregnancies. Spectrum incorporates our proprietary technology to further screen for uniparental
disomy, in which two copies of a chromosome come from the same parent; confirm parentage; and determine the parental
origin of the chromosomal abnormality.
Anora is our products of conception, or POC, test, which analyzes miscarriage tissue from women who have
experienced one or more pregnancy losses to determine whether there was an underlying chromosomal reason for the loss.
Anora can detect trisomy, triploidy, extra or missing chromosome pieces, and uniparental disomy. The Anora test is helpful
to obstetricians, gynecologists and IVF physicians in supporting their patients’ reproductive goals. Anora can help couples
understand the likelihood of another miscarriage, their future reproductive options, and whether there are any steps that
may help them avoid a miscarriage in future pregnancies.
Our non-invasive prenatal paternity product allows a couple to safely establish paternity without waiting for the
child to be born. Testing can be done as early as nine weeks in gestation using a blood draw from the pregnant mother and
alleged father. Our internal data indicates that the accuracy of this test is greater than 99.99%. We have licensed this
technology to a third party to perform the test in its clinical laboratory.
Constellation
Our Constellation software forms the core of our cloud-based distribution model. Through this model, we have
been able to expand access to our molecular and bioinformatics capabilities worldwide, enabling laboratories, under a
license from us, to run the molecular workflows themselves and then access our computation-intensive bioinformatics
algorithms through Constellation, which runs in the cloud, to analyze the results. As of February 1, 2020, 14 licensees are
using our Constellation platform commercially, including 13 in NIPT and one in prenatal paternity testing. We have
licensing contracts with various other laboratories in the United States and internationally to develop products in both
NIPT and oncology. Our licensees are in various stages of development and implementation of an NIPT product. We
leverage Constellation to enhance adoption of our tests among laboratory licensees globally, and to perform our internal
commercial laboratory activities and research and development of our products.
We have received CE Marks from the European Commission for our Constellation software and for the key
reagents that our laboratory licensees need to run their portion of the Panorama test prior to accessing our algorithms
through Constellation. These CE Marks enable us to offer Constellation in the European Union and other countries that
accept a CE Mark. We are pursuing other regulatory approvals, as needed, to allow the international roll out of
Constellation in regions that do not accept a CE Mark.
We believe that our cloud-based distribution model provides us with a competitive advantage by allowing us to,
among others, accelerate international adoption by leveraging our licensees’ existing capabilities, efficiently achieve scale,
and reduce costs.
Signatera
MRD assessment has become a standard of care in the management of patients with hematological malignancies,
but until now it has not been possible in solid tumor cancers due to technical limitations. Accurate MRD testing and
molecular monitoring offers the potential for physicians to change or escalate treatment in patients who are MRD-positive,
and to de-escalate or avoid unnecessary treatment in patients who are MRD-negative. It also holds potential as a surrogate
endpoint in clinical trials.
Signatera is a personalized circulating tumor DNA (ctDNA) blood test for MRD assessment and surveillance of
disease recurrence in patients previously diagnosed with cancer. Each patient receives a custom assay that tracks the
presence of 16 tumor-specific clonal mutations that are selected based on the unique mutational signature found in that
patient’s tumor tissue, which is intended to maximize accuracy for detecting the presence or absence of residual disease
in a blood sample, even at variant allele frequency (VAF) of mutations as low as 0.01% in the blood. We believe this
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approach is optimal in the MRD setting, in which it is common for tumor DNA to be present only at low frequencies
immediately after treatment. Unlike static liquid biopsy panels, which screen for a generic set of mutations independent of
an individual’s tumor, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to
detect and quantify how much cancer is left in the body, detect recurrence earlier, and help optimize treatment decisions.
Signatera can detect residual disease earlier than clinical or radiological recurrence in patients with solid tumors who have
received treatment.
We launched Signatera in 2017 for research use only to cancer researchers and biopharmaceutical companies.
Signatera was commercially launched in May 2019 for clinical use as an LDT in our own CLIA-certified and CAP-
accredited laboratory. In August 2019, we received a Medicare positive draft local coverage determination for certain
forms of colorectal cancer. Signatera has been designated as a Breakthrough Device by the FDA for use in the post-surgical
detection and quantification of ctDNA in patients previously diagnosed with certain types of cancer and in combination
with certain drugs.
Signatera has been shown in various clinical studies to identify MRD significantly earlier than standard diagnostic
tools, and that Signatera test status is a significant indicator of long-term patient outcomes after surgery and treatment,
relative to other clinical and pathological factors. In a clinical validation study conducted in collaboration with Aarhus
University in Denmark, published in JAMA Oncology, Signatera detected relapse in patients with Stage II-III colorectal
cancer an average of 8.7 months earlier than standard diagnostic tools. Patients who remained MRD-negative throughout
the study had significantly reduced risk of relapse, as low as 3%. This study, along with another research collaboration
with Aarhus University in locally advanced muscle invasive bladder cancer, published in Journal of Clinical Oncology,
demonstrated the ability of Signatera to stratify patients by whether they are MRD positive or negative based on post-
treatment presence or absence of ctDNA in the blood. In both the colorectal and bladder cancer studies, a positive Signatera
test result after treatment was the strongest prognostic marker of disease recurrence and long-term patient outcomes,
relative to all other risk factors.
We have also published results in lung cancer. Our technology was selected for use in Cancer Research
UK/University College London’s Tracking Cancer Evolution through Therapy (TRACERx) clinical trial for the multi-
year monitoring of patient-specific SNVs in plasma, to understand the evolution of cancer mutations over time, and to
monitor patients for disease recurrence. Results from the first 100 early-stage lung cancer patients analyzed as part of the
study were featured on the cover of the May 2017 issue of Nature and showed that an early prototype version of Signatera
identified 43% more ctDNA-positive early-stage lung cancer cases than a generic lung cancer panel and demonstrated its
potential to detect residual disease, measure treatment response, and identify recurrence an average of four months earlier
than the standard of care, with a sensitivity of 93% at time of relapse.
We have also completed two studies in breast cancer. In our study with Cancer Research UK-funded researchers
at Imperial College London and the University of Leicester, U.K. published in Clinical Cancer Research, which included
patients with all three of the key breast cancer subtypes (ER+, HER2+, and Triple Negative), Signatera detected molecular
residual disease with a lead time of up to two years prior to clinical or radiological detection, and overall detected clinical
relapse with a sensitivity of 89% at time of relapse. Our second study in breast cancer, the Investigation of Serial Studies
to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY 2) trial with the University of
California, San Francisco and QuantumLeap Healthcare Collaborative, launched in 2010, was a multi-center study
evaluating the safety and efficacy of investigational therapies combined with early treatment in women with newly
diagnosed, locally advanced breast cancer. The results of this trial demonstrated that the change of measurable ctDNA
from positive to negative during neoadjuvant treatment predicted therapeutic response, while failure to clear ctDNA after
neoadjuvant treatment correlated with poor clinical outcomes. ctDNA levels were also associated with disease burden as
determined by imaging.
We are currently conducting research across multiple cancer types in collaboration with various cancer centers
and pharmaceutical companies. For example, Signatera has been selected as the MRD test to be used in the Japan arm of
the CIRCULATE-IDEA trial to evaluate ctDNA-guided treatment strategies for patients with Stage II-III colon cancer. If
successful, this trial could result in the adoption of MRD testing into current medical practice as well as reimbursement of
MRD testing in Japan. In addition, we have launched BESPOKE CRC, a nationwide, multi-center, 1,000-patient registry
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study for patients diagnosed with Stage II-III colorectal cancer. The objective of the BESPOKE CRC study is to measure
the impact of Signatera test results on changes in treatment decisions and clinical outcomes.
Prospera
We are also applying our technology to organ transplant rejection, and are initially focused on kidney transplants.
The current tools for assessing organ transplant rejection are either invasive (biopsies) or inaccurate (serum creatinine),
resulting in an unmet need for better diagnostic tools to monitor for allograft rejection and improve patient management
and outcomes. Many patients are still subjected to unnecessary biopsies, while other patients remain undiagnosed in the
case of subclinical rejection, which can increase the risk of graft failure. Our assay, Prospera, is designed to assess active
rejection in patients who have undergone kidney transplantation by measuring the fraction of dd-cfDNA in the recipient's
blood, which can spike relative to background cfDNA when the transplanted organ is injured due to immune rejection.
Prospera is designed for use by physicians to assess active rejection, helping to rule in or rule out the condition when
evaluating the need for diagnostic testing or the results of an invasive biopsy, and thereby potentially lowering the overall
costs associated with transplant care and improving graft survival. We received a final Medicare local coverage
determination, or LCD, for Prospera in December 2019, covering all kidney transplant recipients, including those with
multiple kidney transplants, and are working towards a full-scale commercial launch in 2020.
Our clinical validation study, conducted in collaboration with the University of California, San Francisco, a
recognized leader in transplantation care, and published in the Journal of Clinical Medicine, demonstrated strong
performance of our mmPCR technology for detecting active rejection in patients with kidney transplants. In the blinded,
retrospective study, we leveraged our SNP technology to measure dd-cfDNA levels in plasma samples from kidney
transplant patients, including patients experiencing active rejection. Our assay demonstrated 89% sensitivity in detecting
active rejection, with specificity of 73%, based on a cutoff of 1% dd-cfDNA. The assay performed particularly well in
detecting T-cell mediated rejection (TCMR) and subclinical rejection, both of which we believe are areas of unmet need.
In an analytical validation study published in the February 2019 issue of Transplantation, our assay demonstrated
superior precision, up to 5 times better than the competing dd-cfDNA assay. Precision is a measure of the test’s ability to
produce the same result when a single sample is tested repeatedly. This study also included donor-recipient pairs that were
related, such as parents or siblings, as well as those that were not related. This is significant because an estimated 52% of
live kidney donations are from a biological relative of the patient, but it is technically challenging to differentiate between
DNA patterns of close relatives. We were able to achieve a high degree of accuracy in these challenging cases by
leveraging our experience with SNP-based methods in the reproductive health setting.
We are currently enrolling participants in our ProActive registry study, one of the industry’s largest known
prospective studies to date incorporating dd-cfDNA testing into medical management of organ transplant recipients. The
study is expected to enroll 3,000 kidney transplant patients from the time of surgery, and will measure changes in biopsy
usage and clinical outcomes based on physician-directed use of the Prospera test to rule in or rule out active rejection. The
study protocol calls for most patients to be followed for three years, while a subset of high-risk patients will be studied up
to five years after transplantation. We have also been selected to participate in a global, prospective multicenter study on
collaboration with Molecular Microscope Diagnostic System, in which 300 patients will be evaluated on the basis of
clinical information, cfDNA measures, biopsies, molecular microscope, evaluations, and donor-specific antibodies to
assess the potential benefits of integrated data analysis in managing kidney transplantation.
Direct Sales Force and Global Distribution Network
Through our direct sales efforts and worldwide network of over 100 laboratory and distribution partners, we have
established a broad distribution channel. Our own direct sales force and managed care teams anchor our commercial
engagement with physicians, laboratory partners, and payers, and sell directly to MFMs, OB/GYNs, physicians or
physician practices, IVF centers, or integrated health systems. In the NIPT market, Panorama is typically ordered for a
patient by an MFM or OB/GYN. OB/GYNs primarily practice generalist medicine for women's health; they typically only
assist women with average risk pregnancies and will refer women with high risk pregnancies to an MFM. We believe that
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Panorama will continue to be adopted by physicians for broader use in average risk pregnancies, and therefore anticipate
that we will continue to see an increasing proportion of Panorama orders in the future from OB/GYNs.
Where our sales force can access physician offices directly, as in the U.S. market, we are able to maximize cross-
selling opportunities by offering the full portfolio of our products. For example, we are promoting the use of Panorama
NIPT, our Panorama microdeletions panel, and Horizon together for pregnant women who have not had a CS test at the
time they are ready to have an NIPT performed. These tests can all be run using one blood draw from the mother and can
be ordered on one requisition form and with one shipment of the patient’s samples by the physician. Also, because of the
importance and demand for screening for 22q11.2 deletion syndrome, we have included that feature as part of our basic
Panorama panel, unless the patient or physician ordering the test opts out of the 22q11.2 deletion syndrome screen. In the
year ended December 31, 2019, approximately 71% of customers who ordered the basic Panorama panel directly from us
also ordered screening for 22q11.2 deletion syndrome or the full microdeletions panel, and approximately 35% of
customers who ordered Panorama directly from us also ordered Horizon carrier screening.
We plan to market Signatera to oncologists through our direct sales force. We have entered into an agreement
with a transplant diagnostics company to co-market Prospera in the United States in conjunction with our direct sales force.
We generate a higher gross margin when we sell testing services directly, compared to when our products are
distributed by laboratory partners to be performed at our CLIA-certified laboratory. The percentage of our revenues
generated through the higher margin U.S. direct sales force channel was approximately 80% in 2019, compared to
approximately 83% in 2018 and approximately 84% in 2017.
In addition to our sales force, we market to physicians through clinical journals, educational webinars,
conferences, tradeshows and e-mail marketing campaigns. While we currently do not sell directly to patients, we do engage
in brand awareness campaigns directed at patients to highlight our products. Our marketing and medical science liaison
teams work extensively with key opinion leaders in the reproductive health, oncology and organ transplant fields. We also
dedicate resources to assist our laboratory partner network in marketing Panorama and our other products by conducting
joint events, joint advertising and developing joint tools with our partner network.
We generate the highest gross margins on royalty revenue collected from laboratories that run tests in their own
facilities and have the sequencing data analyzed by our Constellation software under our cloud-based distribution model.
As of February 1, 2020, 14 signed licensees are commercializing products using our Constellation platform. We have
licensing contracts with other laboratory licensees, both in the United States and internationally, to develop their own
NIPT LDTs and access our algorithm through our Constellation platform.
Our partners' capabilities augment our direct sales capabilities, and where we have identified laboratory or
distribution partners who share our focus on premium quality and service, we also contract with them to distribute our
tests. In NIPT, we have partnered with leading academic and commercial laboratories and hospital systems in the United
States to capitalize on their relationships with MFMs and OB/GYNs, large distribution capabilities, and commercial
infrastructure. These distribution partners also frequently have in-network contracts with key third party payers. As of
December 31, 2019, we had in-network contracts with insurance providers that accounted for over 212 million covered
lives in the United States. We continue our efforts to increase the number of our in-network contracts with payers. Our
target market for NIPT is a much smaller subset of these covered lives, because it excludes men, children and post-
menopausal women who would not be users of the majority of our products. In organ transplant, we have partnered with
a transplant diagnostics company, leveraging its established commercial infrastructure to co-market Prospera in the United
States. Outside of the United States, where our products are sold in over 80 countries, we currently sell predominantly
through partner laboratories.
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Enhanced User Experience
Natera Digital Services
We have created an integrated platform encompassing various digital services designed to enhance the patient
and provider experience.
Our patient portal is a one-stop resource for patients to access information and services throughout their
experience with our products, from pre-test to post-test. After logging on to the patient portal, patients are able to easily
access information about our tests and services, order tests, track their status and access results, and pay their bill, among
others. We have implemented a price transparency tool whereby patients can receive an estimate of their test cost and out
of pocket responsibility. We believe that these cost estimation features provide peace of mind to patients and providers
and helps to mitigate cost concerns as a barrier to NIPT adoption.
Natera Connect is our physician portal, which enables physicians to easily complete various tasks online including
ordering tests, tracking the status of a patient's test, reviewing patient results online, sharing results with patients,
connecting with genetic counselors, ordering supplies and educational materials, and offering live chat support. We have
also recently launched our Simple Ordering platform, through which providers can initiate and track test orders, including
consenting patients, and access billing and other documentation. Patients can access pre-test education and test cost
estimates, and schedule blood draws, through this platform. We also provide a service to integrate with our customers'
Electronic Medical Records, or EMR, systems to provide physicians a seamless experience of ordering tests and reviewing
patient test results directly through their EMR systems.
Access to Genetic Counselors
After receiving a report with results from any of our products, doctors have access by phone to our team of genetic
counselors should they have any questions or require any guidance in interpreting the results. Patients themselves may
contact our genetic counselors for information by phone either before or after taking one of our tests, with direct access
provided to all patients who are tested with Spectrum or Anora and patients who have a high-risk result for a genetic
disease based on Horizon screening or for a microdeletion syndrome based on Panorama screening.
Phlebotomy Services
We have a network of over 2,000 phlebotomy centers in the United States. We also offer mobile phlebotomy
services whereby a patient can request and schedule a phlebotomist visit at the patient’s home or office.
Other Future Applications of our Technology
We intend to refine and expand our offerings by leveraging our core technology and the data we gather as our
sample volumes grow. For example, the microdeletion samples that we gather through Panorama NIPT or through Anora
POC testing help us to refine the algorithms that detect these anomalies, determine the exact genetic regions where these
anomalies are sought, and increase the accuracy with which they are reported. We have substantial intellectual property
covering the analysis of single cells, an approach we use to analyze embryos with our Spectrum products to improve the
success of IVF. We believe that our technology may allow us to capitalize on future advances in isolating fetal cells from
a mother's blood, which could allow us to measure more of the fetal genome non-invasively and with even higher accuracy,
and potentially enable us to replace invasive confirmatory procedures, such as amniocentesis, over time. Importantly, we
believe that we have a distinct advantage in our opportunity in single-cell isolation because our technology can not only
analyze very small samples, but can also confirm that the cells are fetal as opposed to maternal.
We believe that, in the future, our informatics technology may have the ability to generate a nearly full genome
of an individual, roughly nine weeks after the individual is conceived. Publications in Genome Medicine, Science and
PLoS Genetics highlight the ability of our informatics technology to determine which chromosome segments from the
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parent contributed to the DNA of the fetus and hence to substantially reconstruct the genome of the fetus using only a tiny
amount of fetal DNA. This enhanced view of the full genome early in life, combined with knowledge of the parent DNA,
has the potential to substantially impact the management of many aspects of an individual's health, from birth through
adulthood. Future applications of such an offering may include prediction of disease susceptibilities and appropriate
interventions, selection of drugs and drug dosages, nutrition guidance and many other emerging applications.
We believe that our ability to design custom panels and targeted assays can be utilized in various research
applications such as variant discovery and mechanism of action studies, among others, and clinical applications in
diagnostics and therapeutics. Some areas that we believe other researchers and laboratories may be interested in applying
this technology are: forensic identity analysis in mixtures for law enforcement, agricultural sample screening for patented
lines, prenatal relationship testing for veterinary breeding and cell line purity testing for cell repositories. We are also
investigating the potential application of our technology to other specimen types beyond blood, such as urine or sputum,
which may have applications in the oncology diagnostics field.
Key Relationships
Illumina
We are party to a supply agreement with Illumina, Inc., or Illumina, for the supply of Illumina genetic sequencing
instruments and reagents for NIPT, oncology and transplant diagnostic testing. For oncology, we also received rights to
develop and sell in vitro diagnostic kits and services worldwide, in exchange for which we agreed to make certain milestone
and royalty payments to Illumina. During the term of the supply agreement, which expires in June 2026, Illumina has
agreed to supply us with sequencers, reagents and other consumables for use with the Illumina sequencers, and we must
provide a forecast, on a monthly basis, detailing our needs for certain of the Illumina products. The first four calendar
months of each forecast are binding and the fourth month can vary by only up to 25% more or less than what was forecasted
for that month in the prior month's forecast. In addition, during each calendar quarter, we must spend a minimum amount
on reagents under this agreement. We and Illumina have agreed on prices for the sequencers and reagents, for which we
are entitled to certain discounts based on total spend and other factors. Illumina has the right to adjust these prices under
certain conditions. In addition, we must pay a fee to Illumina for each clinical NIPT test that we perform using Illumina
reagents. Illumina is currently the sole supplier of our sequencers and related reagents for many of our tests, along with
certain hardware and software; we are not bound to use exclusively Illumina's sequencing instruments and reagents for
conducting our sequencing, but if we use other sequencing instruments and reagents for NIPT clinical use, we may no
longer be entitled to discounts from Illumina.
Illumina may terminate the agreement upon the following circumstances: if we materially breach the agreement
and fail to cure such breach within 30 days after receiving written notice of such breach, and only after complying with
additional notice provisions; if we become the subject of certain bankruptcy or insolvency proceedings or in connection
with certain changes of control of Natera. Illumina also has the right to terminate: (a) certain rights under the agreement
upon two years’ prior notice; and (b) our rights with respect to IVDs if we have not obtained a premarket approval for at
least one IVD from the United States Food and Drug Administration by June 8, 2021, unless we are diligently pursuing
approval of an active PMA application at such time. We may terminate the agreement: if Illumina materially breaches the
agreement and fails to cure such breach within 30 days after receiving written notice of such breach, and only after
complying with additional notice provisions; if Illumina becomes the subject of certain bankruptcy or insolvency
proceedings; in connection with certain supply failures by Illumina or for convenience with four months written notice.
The agreement also contains use limitations, representations and warranties, indemnification, limitations of liability and
other provisions.
Competition
The markets in which we operate are characterized by innovation and rapid change, and we primarily face
competition from various companies that develop and commercialize molecular diagnostic tests in reproductive health,
oncology, and organ transplant rejection. Our competitors in the NIPT space include Sequenom, Inc., or Sequenom, which
was recently acquired by Laboratory Corporation of America Holdings, or LabCorp; Illumina, through its subsidiary
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Verinata; Ariosa, Inc., a subsidiary of F. Hoffman La-Roche Ltd, or Roche; Myriad Genetics, Inc., which has acquired
Counsyl, Inc.; Invitae Corp.; Quest Diagnostics Incorporated, or Quest; Premaitha Health PLC; BGI; Progenity, Inc., or
Progenity; and Bio-Reference, a business unit of OPKO Health, Inc. and which was previously a laboratory distribution
partner of ours. We also compete against companies providing carrier screening tests such as LabCorp; Myriad Genetics,
Inc.; Invitae Corp.; Progenity; Recombine Inc.; Quest; and GenPath Diagnostics, a business unit of Bio-Reference. Each
of these companies offers comprehensive CS panels.
In the field of ctDNA-based MRD assessment and recurrence surveillance, we compete with various companies
that offer or seek to offer competing solutions, such as Roche Diagnostics, Guardant Health, Inc., Adaptive
Biotechnologies, Personal Genome Diagnostics, Inc., Exact Sciences Corp., and ArcherDX, Inc.
In transplant rejection, our competitors include CareDx, Inc. and Eurofins Viracor, Inc.
We expect additional competition as other established and emerging companies enter these markets, including
through business combinations, and as new tests and technologies are introduced. These competitors could have greater
technological, financial, reputational and market access resources than us.
We believe the principal competitive factors in our molecular diagnostic testing markets include the following:
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test performance, as demonstrated in clinical and analytical studies and clinical trials as well as in
commercial experience;
comprehensiveness of coverage and ease of use;
value of product offerings, including pricing and impact on other healthcare spending;
scope and extent of reimbursement and payer coverage;
effectiveness of sales and marketing efforts;
breadth of distribution of products and partnership base;
reputation among patients and providers for development and introduction of new, innovative products;
operational execution, including test turn-around time and test failures;
key opinion leader support;
brand awareness; and
ease of integration for laboratories, including for cloud-based distribution models.
Specific market share data regarding our products is not publicly available, and consumers may choose to use
competing products for a variety of reasons, including lower cost. We believe, however, that we compete favorably in the
reproductive health market on the basis of several factors, particularly test performance, comprehensiveness of coverage
of diseases, ability to conveniently test for multiple conditions, value of product offerings and effectiveness of sales and
marketing efforts. In oncology, we believe that the sensitivity and specificity of our personalized, tumor-informed assay
for MRD compares favorably to static-panel based MRD tests in detecting residual disease or recurrence after treatment,
and in impacting treatment decisions.
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Intellectual Property
Our success and ability to compete depend in part on securing and preserving enforceable patent, trade secret,
trademark and other intellectual property rights; operating without having competitors infringe, misappropriate or
otherwise circumvent these rights; operating without infringing the proprietary rights of others; and obtaining and
maintaining licenses for technology development and/or product commercialization. As of December 31, 2019, we held
74 issued U.S. and foreign patents, which expire between November 2026 and December 2036, and over 100 pending U.S.
and foreign patent applications. Our patents and patent applications relate generally to molecular diagnostics, and more
specifically to biochemical and analytical techniques for obtaining and analyzing genetic information to detect genetic
abnormalities in relatively small complex samples, such as cell free fetal DNA or circulating tumor DNA. We intend to
seek patent protection as we develop new technologies and products in this area.
In the past, parties have filed, and in the future parties may file, claims asserting that our technologies or products
infringe on their intellectual property. We have also filed lawsuits asserting intellectual property infringement claims
against third parties. For example, we are currently involved in patent infringement litigation with Illumina, CareDx, Inc.,
and ArcherDX, Inc., and have in the past been involved in patent infringement litigation with Sequenom. We cannot
predict whether other parties will assert such claims against us, or whether those claims will harm our business; nor whether
we will be required to assert such claims against third parties in order to protect our own intellectual property. The field
of molecular diagnostics is complex and rapidly evolving, and we expect that we and others in our industry will continue
to be subject to third-party infringement claims.
Reimbursement
We receive reimbursement from commercial third-party payers and from government health benefits programs
such as Medicare and Medicaid. We receive reimbursement for our Panorama, Horizon, Vistara, Anora and Spectrum tests,
and are in the process of pursuing reimbursement for our Signatera CLIA test and transplant rejection test, both of which
we are currently developing for commercialization.
Laboratory tests, as with most other healthcare services, are classified for reimbursement purposes under a coding
system known as Current Procedure Terminology, or CPT, which we and our customers must use to bill and receive
reimbursement for our diagnostic tests. These CPT codes are associated with the particular test that we have provided to
the patient. Once the American Medical Association establishes a CPT code, the Centers for Medicare & Medicaid
Services, or CMS, establishes payment levels and coverage rules under Medicare while private payers establish rates and
coverage rules independently. For most of the tests performed for Medicare or Medicaid beneficiaries, laboratories are
required to bill Medicare or Medicaid directly, and to accept Medicare or Medicaid reimbursement as payment in full.
Prior to 2015, CMS had implemented a set of CPT codes without a fee schedule for most codes specific to NIPTs; however,
a CPT code specific to NIPT for aneuploidies has been effective since January 2015, and a CPT code for microdeletions
has been effective since January 2017. CMS has established a pricing benchmark of $802 for aneuploidy and
microdeletions testing. In addition, a CPT code for expanded carrier screening tests went into effect in January of this year,
for which CMS has established a pricing benchmark of approximately $2,450.
We currently submit for reimbursement using CPT codes based on the guidance of coding experts and outside
legal counsel. There is a risk that these codes may be rejected or withdrawn or that payers will seek refunds of amounts
that they claim were inappropriately billed to a specific CPT code. We do not currently have a specific CPT code assigned
for all of our tests, and there is a risk that we may not be able to obtain specific codes for such tests, or if obtained, we may
not be able to negotiate favorable rates for one or more of these codes. In particular, while we have obtained a CPT code
for microdeletions and CMS has set a price for microdeletions testing, we expect that our microdeletions reimbursement
will decline, at least in the near term, because third-party payers are declining to reimburse under the new code or
reimbursing at a much lower rate than we had previously received before the CPT code was established. The
reimbursement rates for our broader Horizon screening panel may also decline as a result of the new CPT code becoming
effective in 2019, as carrier screening tests that had previously been reimbursed on a per-condition basis may be reimbursed
as a combined single panel instead of as multiple individual tests.
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NIPT has received positive coverage determinations for high-risk pregnancies and are reimbursed by most private
payers, including United Healthcare, AETNA, Anthem, Humana, CIGNA and others. Reimbursement policies for the use
of NIPT for average-risk pregnancies have not been widely established, but recent publications have analyzed the use of
NIPT in the average-risk population and certain medical societies have supported such use. In particular, ACMG has issued
guidelines recommending that pregnant women be informed that NIPT is the most sensitive screening option for Patau,
Edwards and Down syndromes, as well as of the availability of the expanded use of NIPT to screen for clinically relevant
CNVs in the context of counseling that includes the risks/benefits and limitations of screening for CNVs. ISPD has issued
guidelines that are supportive of NIPT in average-risk pregnancies as well as high-risk pregnancies. However, SMFM has
issued a guideline stating that while all pregnant women should be informed of the option to receive NIPT, conventional
screening methods, rather than NIPT, remain the most appropriate choice for first-line screening for average-risk
pregnancies. ACOG has withdrawn its previous guideline, which was consistent with SMFM’s guideline, and it remains
uncertain when ACOG will issue a new guideline as well as whether and to what extent such guideline may be supportive
of NIPT in the average-risk setting. Private payers are moving towards reimbursing for average-risk NIPT. Fifty-nine
commercial payers in the United States, representing close to half of all commercial covered lives in the United States,
and several state Medicaid programs, have a positive coverage determination for NIPT for average-risk pregnancies.
As of December 31, 2019 we and our laboratory partners had in-network contracts with insurance providers that
accounted for over 212 million covered lives in the United States. Our target market for NIPT is a much smaller subset of
these covered lives, because it excludes men, children and post-menopausal women who would not be users of our products.
Government Regulations
Our business is subject to and impacted by extensive and frequently changing laws and regulations in the United
States (at both the federal and state levels) and internationally. These laws and regulations include regulations particular
to our business and laws and regulations relating to conducting business generally (e.g., export controls laws, U.S. Foreign
Corrupt Practices Act and similar laws of other jurisdictions). We also are subject to inspections and audits by
governmental agencies. Set forth below are highlights of certain key regulatory schemes applicable to our business.
Clinical Laboratory Improvement Amendments of 1988 and State Regulation
As a clinical laboratory, we are required to hold certain federal and state licenses, certifications and permits to
conduct our business. As to federal certifications, in 1988, Congress passed the Clinical Laboratory Improvement
Amendments of 1988, or CLIA, establishing more rigorous quality standards for all commercial laboratories that perform
testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease
or the assessment of the health or impairment of human beings. CLIA requires such laboratories to be certified by the
federal government and mandates compliance with various operational, personnel, facilities administration, quality and
proficiency testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results. CLIA
certification is also a prerequisite to be eligible to bill state and federal healthcare programs, as well as many commercial
third-party payers, for laboratory testing services.
Our laboratory located in San Carlos, California is CLIA certified. Our laboratory must comply with all applicable
CLIA requirements. If a clinical laboratory is found to be out of compliance with CLIA standards, CMS may impose
sanctions, limit or revoke the laboratory’s CLIA certificate (and prohibit the owner, operator or laboratory director from
owning, operating, or directing a laboratory for two years following license revocation), a directed plan of correction, on-
site monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties, or suspension or exclusion
from the Medicare and Medicaid programs.
CLIA provides that a state may adopt laboratory licensure requirements and regulations that are more stringent
than those under federal law, and requires compliance with such laws and regulations. A number of states have
implemented their own more stringent laboratory regulatory requirements. State laws may require the laboratory to obtain
state licensure and/or laboratory personnel to meet certain qualifications, specify certain quality control procedures or
facility requirements, or prescribe record maintenance requirements. Moreover, several states impose the same or similar
state requirements on out-of-state laboratory testing specimens collected or received from, or test results reported back to,
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residents within that state. Therefore, we are required to meet certain laboratory licensing requirements for those states in
which we offer services or from which we accept specimens and that have adopted regulations beyond CLIA. For more
information on state licensing requirements, see ‘‘—California Laboratory Licensing’’, ‘‘—New York Laboratory
Licensing,’’ and ‘‘—Other State Laboratory Licensing Laws.’’
Our laboratory has also been accredited by the College of American Pathologists, or CAP, which means that our
laboratory has been certified as following CAP standards and guidelines in operating the laboratory facility and in
performing tests that ensure the quality of our test results.
FDA
In the United States, medical devices are subject to extensive regulation by the Food and Drug Administration,
or FDA, under the Federal Food, Drug, and Cosmetic Act, or FDC Act, and its implementing regulations, and other federal
and state statutes and regulations. The laws and regulations govern, among other things, medical device development,
testing, labeling, storage, premarket clearance or approval, advertising and promotion and product sales and distribution.
To be commercially distributed in the United States, medical devices must receive from the FDA prior to marketing, unless
subject to an exemption, clearance of a premarket notification, or 510(k), premarket approval, or a PMA, or a de novo
authorization.
IVDs are a type of medical device that can be used in the diagnosis or detection of diseases, conditions or
infections, including, without limitation, the presence of certain chemicals, genetic information or other biomarkers.
Predictive, prognostic and screening tests, such as carrier screening tests, can also be IVDs. A subset of IVDs are known
as analyte specific reagents, or ASRs. ASRs consist of single reagents, and are intended for use in a diagnostic application
for the identification and quantification of an individual chemical substance in biological specimens. ASRs are medical
devices, but most are exempt from the premarket review processes. As medical devices, ASRs have to comply with some
quality system regulation, or QSR, provisions and other device requirements.
The FDC Act classifies medical devices into one of three categories based on the risks associated with the device
and the level of control necessary to provide reasonable assurance of safety and effectiveness. Class I devices are deemed
to be low risk and are subject to the fewest regulatory controls. Many Class I devices are exempt from FDA premarket
review requirements. Class II devices, including some software products to the extent that they qualify as a device, are
deemed to be moderate risk, and generally require clearance through the premarket notification, or 510(k) clearance,
process. Class III devices are generally the highest risk devices and are subject to the highest level of regulatory control to
provide reasonable assurance of the device's safety and effectiveness. Class III devices typically require a PMA by the
FDA before they are marketed. A clinical trial is almost always required to support a PMA application and is sometimes
required for 510(k) clearance. All clinical studies of investigational devices must be conducted in compliance with any
applicable FDA and Institutional Review Board requirements. Devices that are exempt from FDA premarket review
requirements must nonetheless comply with post-market general controls as described below, unless the FDA has chosen
otherwise.
510(k) clearance pathway. To obtain 510(k) clearance, a manufacturer must submit a premarket notification
demonstrating to the FDA's satisfaction that the proposed device is substantially equivalent to a previously 510(k)-cleared
device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for
submission of PMA applications. The previously cleared device is known as a predicate. The FDA's 510(k) clearance
pathway usually takes from three to 12 months from submission, but it can take longer, particularly for a novel type of
product.
PMA pathway. The PMA pathway requires proof of the safety and effectiveness of the device to the FDA's
satisfaction. The PMA pathway is costly, lengthy, and uncertain. A PMA application must provide extensive preclinical
and clinical trial data as well as information about the device and its components regarding, among other things, device
design, manufacturing, and labeling. As part of its PMA review process, the FDA will typically inspect the manufacturer's
facilities for compliance with QSR requirements, which impose elaborate testing, control, documentation, and other quality
assurance procedures. The PMA review process typically takes one to three years from submission but can take longer.
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De novo pathway. If no predicate device can be identified, the product is automatically classified as Class III,
requiring a PMA application. However, the FDA can reclassify, or use "de novo classification," for a device for which
there was no predicate device if the device is low- or moderate-risk. If the device is deemed Class II, the FDA will identify
"special controls" that the manufacturer must implement, which often include labeling and other restrictions. Subsequent
applicants can rely upon the de novo product as a predicate for a 510(k) clearance, unless FDA exempts subsequent devices
from the need for a 510(k). The de novo route is less burdensome than the PMA process, but FDA has issued a proposed
regulation that, if adopted as written, would increase the regulatory burden in obtaining a de novo authorization. A device
company can ask the FDA at the outset if the de novo route is available and submit the application as one requesting de
novo classification. The de novo route has been used for many IVD products. The FDA has indicated to us that our software
that enables our cloud-based distribution model may be appropriate for review under the de novo classification process.
However, the FDA has not committed to this position and may take a different position in the future.
Post-market general controls. After a device, including a device exempt from FDA premarket review, is placed
on the market, numerous regulatory requirements apply. These include: the QSR, labeling regulations, registration and
listing, the Medical Device Reporting regulation (which requires that manufacturers report to the FDA if their device 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), and the Reports of Corrections and Removals regulation (which requires
manufacturers to report recalls and field actions to the FDA if initiated to reduce a risk to health posed by the device or to
remedy a violation of the FDC Act).
The FDA enforces these requirements by inspection and market surveillance. If the FDA finds a violation, it can
institute a wide variety of enforcement actions, ranging from an untitled or public warning letter to more severe sanctions
such as fines, injunctions, and civil penalties; recall or seizure of products; operating restrictions, partial suspension or
total shutdown of production; refusing requests for 510(k) clearance or PMA approval of new products; withdrawing
510(k) clearance or PMAs already granted; and criminal prosecution. For additional information, see "Risk Factors—
Reimbursement and Regulatory Risks Related to Our Business."
Research use only. Research use only, or RUO, products belong to a separate regulatory classification under a
long-standing FDA regulation. RUO products are not regulated as medical devices and are therefore not subject to the
regulatory requirements discussed above. The products must bear the statement: “For Research Use Only. Not for Use in
Diagnostic Procedures.” RUO products cannot make any claims related to safety, effectiveness or diagnostic utility, and
they cannot be intended for human clinical diagnostic use. A product labeled RUO but intended to be used diagnostically
may be viewed by the FDA as adulterated and misbranded under the FDC Act and is subject to FDA enforcement activities,
including requiring the supplier to seek clearance, approval or authorization for the products. Our LDTs use instruments
and reagents labeled as RUO.
Laboratory-developed tests. LDTs have generally been considered to be tests that are designed, developed,
validated and used within a single laboratory. The FDA takes the position that it has the authority to regulate such tests as
medical devices under the FDC Act. The FDA has historically exercised enforcement discretion and has not required
clearance or approval of LDTs prior to marketing.
On October 3, 2014, the FDA issued two draft guidance documents regarding oversight of LDTs. These draft
guidance documents proposed more active review of LDTs. The draft guidances were the subject of considerable
controversy, and in November 2016, the FDA announced that it would not be finalizing the 2014 draft guidance documents.
On January 13, 2017, the FDA issued a discussion paper which laid out elements of a possible revised future LDT
regulatory framework, but did not establish any regulatory requirements.
The FDA’s efforts to regulate LDTs have prompted the drafting of legislation governing diagnostic products and
services that sought to substantially revamp the regulation of both LDTs and IVDs. Congress may still act to provide
further direction to the FDA on the regulation of LDTs and substantially modify the regulation of IVDs.
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We believe that other than the RUO version of Signatera, all of the tests we currently offer, including Panorama,
meet the definition of LDTs, as they have been designed, developed, and validated for use in a single CLIA-certified
laboratory. If our tests are LDTs, they are currently not subject to FDA regulation as medical devices.
California Laboratory Licensing
In addition to federal certification requirements for laboratories under CLIA, we are required under California
law to maintain a California state license for our San Carlos clinical laboratory and comply with California state laboratory
laws and regulations. Similar to the federal CLIA regulations, the California state laboratory laws and regulations establish
standards for the operation of a clinical laboratory and performance of test services, including the education and experience
requirements of the laboratory director and personnel (including requirements for documentation of competency);
equipment validations; and quality management practices. All testing personnel must maintain a California state license
or be supervised by licensed personnel.
Clinical laboratories are subject to both routine and complaint-initiated on-site inspections by the state. If a
clinical laboratory is found to be out of compliance with California laboratory standards, the California Department of
Public Health, or CAPH, may suspend, restrict or revoke the California state laboratory license to operate the clinical
laboratory (and exclude persons or entities from owning, operating, or directing a laboratory for two years following
license revocation), assess civil money penalties, and/or impose specific corrective action plans, among other sanctions.
Clinical laboratories must also provide notice to CAPH of any changes in the ownership, directorship, name or location of
the laboratory. Failure to provide such notification may result in revocation of the state license and sanctions under the
CLIA certificate. Any revocation of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs
may result in suspension of the California state laboratory license.
New York Laboratory Licensing
Because we test specimens originating from, and return test results to, New York State, our San Carlos clinical
laboratory is required to obtain a New York state laboratory permit and comply with New York state laboratory laws and
regulations. The New York state laboratory laws, regulations and rules are equal to or more stringent than the CLIA
regulations and establish standards for the operation of a clinical laboratory and performance of test services, including
education and experience requirements of a laboratory director and personnel; physical requirements of a laboratory
facility; equipment validations; and quality management practices. The laboratory director(s) must maintain a Certificate
of Qualification issued by the New York State Department of Health, or DOH, in the permitted test categories.
Our clinical laboratory is subject to proficiency testing and on-site survey inspections conducted by the Clinical
Laboratory Evaluation Program, or CLEP, under the DOH. If a laboratory is found to be out of compliance with New
York’s CLEP standards, the DOH, may suspend, limit, revoke or annul the New York laboratory permit, censure the holder
of the license or assess civil money penalties. Statutory or regulatory noncompliance may result in a laboratory’s operator,
owners and/or laboratory director being found guilty of a misdemeanor under New York law. Clinical laboratories must
also provide notice to CLEP of any changes in ownership, directorship, name or location of the laboratory. Failure to
provide such notification may result in revocation of the state license and sanctions under the CLIA certificate. Any
revocation of a CLIA certificate or exclusion from participation in the Medicare or Medicaid programs may result in
suspension of the New York laboratory permit.
Our clinical laboratory maintains a valid permit in the State of New York for the molecular genetic testing services
furnished by our clinical laboratory in San Carlos, California.
The DOH also must approve each LDT before the test is offered to patients located in New York. Our clinical
laboratory has received approval from New York’s CLEP to offer our basic Panorama test to women with high-risk
pregnancies and a conditional approval to offer both our basic Panorama and Panorama with the microdeletions panel to
all pregnant women, regardless of risk. Our clinical laboratory also holds a New York laboratory permit to offer our
Horizon, Spectrum, Anora and non-invasive prenatal paternity tests, and provisional approval is pending for our Horizon
test under our recently updated workflow.
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Other State Laboratory Licensing Laws
In addition to New York and California, certain other states require licensing of out-of-state laboratories under
certain circumstances. We have obtained licenses in the states that we believe require us to do so, and believe we are in
compliance with applicable state laboratory licensing laws.
Potential sanctions for violation of state statutes and regulations can include significant monetary fines, the
rejection of license applications, the suspension or loss of various licenses, certificates and authorizations, and in some
cases criminal penalties, which could harm our business. CLIA does not preempt state laws that have established laboratory
quality standards that are more stringent than federal law.
State Genetic Testing Laws
Many states have implemented genetic testing and privacy laws imposing specific patient consent requirements
and protecting test results. In some cases, we are prohibited from conducting certain tests without appropriate
documentation of patient consent by the physician ordering the test. As discussed in more detail in “Risk Factors—
Reimbursement and Regulatory Risks Related to our Business--If the validity of an informed consent from a patient intake
for Panorama or our other tests is challenged, we could be precluded from billing for such testing, forced to stop
performing such tests, or required to repay amounts previously received, which would adversely affect our business and
financial results,” while we rely on physicians and our partners to obtain the required patient consent to perform testing,
such consents, or our and our partners’ compliance with applicable laws and regulations, could be challenged.
Requirements of these laws and penalties for violations vary widely.
HIPAA and Other Privacy Laws
The privacy and security regulations under the Health Insurance Portability and Accountability Act of 1996, or
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH,
establish uniform standards governing the conduct of certain electronic healthcare transactions and require certain entities,
called covered entities, to comply with standards that include the privacy and security of protected health information, or
PHI. HIPAA further requires business associates of covered entities—independent contractors or agents of covered entities
that have access to protected health information in connection with providing a service to or on behalf of a covered entity—
to enter into business associate agreements with the covered entity and to safeguard the covered entity’s PHI against
improper use and disclosure. In addition, certain of HIPAA’s privacy and security standards are directly applicable to
business associates.
As a covered entity and as a business associate of other covered entities (with whom we have therefore entered
into business associate agreements), we have certain obligations regarding the use and disclosure of any PHI that may be
provided to us, and we could incur significant liability if we fail to meet such obligations or if our business associates fail
to meet such obligations. Among other things, HITECH imposes civil and criminal penalties against covered entities and
business associates for noncompliance with privacy and security requirements and authorizes states’ attorneys general to
file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees
and costs associated with pursuing federal civil actions.
As noted above, we are required to comply with HIPAA standards promulgated by the U.S. Department of Health
and Human Services, or HHS. First, we must comply with HIPAA’s standards for electronic transactions, which establish
standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the
use of electronic signatures. We must also comply with the standards for the privacy of individually identifiable health
information, which limit the use and disclosure of most paper and oral communications, as well as those in electronic form,
regarding an individual’s past, present or future physical or mental health or condition, or relating to the provision of
healthcare to the individual or payment for that healthcare, if the individual can or may be identified by such information.
Additionally, we must comply with HIPAA’s security standards, which require us to ensure the confidentiality, integrity
and availability of all electronic protected health information that we create, receive, maintain or transmit, to protect against
26
reasonably anticipated threats or hazards to the security of such information, and to protect such information from
unauthorized use or disclosure.
Various states in the United States have implemented similar restrictive requirements regulating the use and
disclosure of health information and other personally identifiable information that are not necessarily preempted by HIPAA,
particularly if a state affords greater protection to individuals than HIPAA. For example, California recently enacted the
California Consumer Privacy Act, which becomes enforceable on July 1, 2020 and creates new consumer rights relating
to the access to, deletion of, and sharing of personal information collected by certain businesses that operate in the state.
In addition, Massachusetts law requires that any company that obtains personal information of any resident of the
Commonwealth of Massachusetts implement and maintain a security program that adequately protects such information
from unauthorized use or disclosure.
There are also foreign privacy and security laws and regulations that impose restrictions on the access, use and
disclosure of health information. In particular, the EU’s General Data Protection Regulation, or GDPR, became effective
in May 2018. The GDPR applies not only to organizations within the EU, but also applies to organizations outside of the
EU, such as Natera, that offer goods or services to EU data subjects or that process or hold personal data of EU data
subjects. The regulation specifies higher potential liabilities for certain data protection violations, and we anticipate that it
will result in a greater compliance burden for us as we conduct our business, particularly through our Constellation cloud-
based distribution model, in the European Union. Fines for non-compliance can range from the greater of 2% of annual
global revenues or €10 million, up to the greater of 4% of annual global revenues or €20 million.
As a business that operates both internationally and throughout the United States, any unauthorized use or
disclosure of personally identifiable information, even if it does not constitute PHI, by us or our third-party contractors,
including disclosure due to data theft or unauthorized access to our or our third-party contractors’ computer networks,
could subject us to costs, fines or penalties that could adversely affect our business and results of operations, including the
cost of providing notice, credit monitoring and identity theft prevention services to affected consumers.
Healthcare Fraud and Abuse Laws
The federal Anti-Kickback Statute makes it a felony for a provider or supplier, including a laboratory, to
knowingly and willfully offer, pay, solicit or receive remuneration, directly or indirectly, in order to induce business that
is reimbursable under any federal healthcare program. A violation of the federal Anti-Kickback Statute may result in
imprisonment for up to ten years and/or criminal fines of up to $100,000, civil assessments and fines up to $100,000, and
exclusion from participation in Medicare, Medicaid and other federal healthcare programs. Although the federal Anti-
Kickback Statute applies only to federal healthcare programs, a number of states have passed laws substantially similar to
the federal Anti-Kickback Statute pursuant to which similar types of prohibitions are made applicable to all other health
plans and third-party payers. Actions which violate the federal Anti-Kickback Statute or similar laws may also involve
liability under the Federal False Claims Act, which prohibits knowingly presenting or causing to be presented a false,
fictitious or fraudulent claim for payment to the U.S. Government.
Federal and state law enforcement authorities scrutinize arrangements between healthcare providers and potential
referral sources to ensure that the arrangements are not designed as a mechanism to induce patient care referrals and
opportunities. Law enforcement authorities, courts and Congress have demonstrated a willingness to look behind the
formalities of a transaction to determine the underlying purpose of payments between healthcare providers and actual or
potential referral sources. Generally, courts have taken a broad interpretation of the scope of the federal Anti-Kickback
Statute, holding that the statute may be violated if merely one purpose of a payment arrangement is to induce future
referrals.
The HHS Office of Inspector General, or OIG, has issued Special Fraud Alerts on arrangements for the provision
of clinical laboratory services and relationships between, among others, laboratories and referring physicians. The Fraud
Alerts set forth a number of practices allegedly engaged in by some clinical laboratories and healthcare providers that raise
issues under the federal fraud and abuse laws, including the federal Anti-Kickback Statute. The OIG emphasized in the
Special Fraud Alerts that when one purpose of such arrangements is to induce referrals of government program-reimbursed
27
laboratory testing, both the clinical laboratory and the healthcare provider (e.g., physician) may be liable under the federal
Anti-Kickback Statute, and may be subject to civil and/or criminal prosecution and exclusion from participation in the
Medicare and Medicaid programs.
Recognizing that the federal Anti-Kickback Statute is broad and may technically prohibit many innocuous or
beneficial arrangements within the healthcare industry, HHS has issued a series of regulatory “safe harbors” for certain
payment arrangements which provide confidence to healthcare providers and other parties that they will not be prosecuted
under the federal Anti-Kickback Statute if they can demonstrate compliance with each element of the safe harbor. Although
full compliance with these provisions ensures against prosecution under the federal Anti-Kickback Statute, the failure of
a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or
arrangement is illegal or that prosecution under the federal Anti-Kickback Statute will be pursued.
While we believe that we are in compliance with the federal Anti-Kickback Statute and similar fraud and abuse
laws, there can be no assurance that our relationships with physicians, hospitals and other customers or vendors will not
be subject to scrutiny or will survive regulatory challenge under such laws. If imposed for any reason, sanctions under the
federal Anti-Kickback Statute or any similar state statute could have a negative effect on our business.
Because our laboratory facility is located in California and licensed by California’s DHS, California law is
applicable to our business arrangements. California’s state anti-kickback statutes, Business and Professions Code Section
650 (which applies to all categories of payors) and Insurance Code Section 754, and its Medi-Cal anti-kickback statute,
Welfare and Institutions Code Section 14107.2, are analogous to, and have been interpreted by the California Attorney
General and California courts in substantially the same way as the federal government and the courts have interpreted, the
federal Anti-Kickback Statute. A violation of Section 650 is punishable by up to one year of imprisonment, a fine up to
$50,000, or both imprisonment and a fine. A violation of Section 14107.2 is punishable by imprisonment and fines of up
to $10,000. The California Insurance Code includes similar prohibitions against any consideration for the referral or
procurement of patients if a claim is submitted to a commercial insurer, CA Ins. Code § 750, which is punishable by
criminal penalties mirroring those that apply to violations of Business and Professions Code Section 650.
Because our laboratory holds a New York CLEP permit, we must comply with New York state laboratory statutes
and regulations, which include anti-kickback provisions, Public Health Law Section 587, and Medicaid anti-kickback
provisions, 18 NYCRR Section 515.2, related to laboratory services. The New York DOH may suspend, limit, revoke or
annul the New York laboratory permit or otherwise discipline the permit holder for a violation.
In addition to the requirements that are discussed above, there are other healthcare fraud and abuse laws that
could have an impact on our business. The federal False Claims Act prohibits a person from knowingly submitting or
causing to be submitted false claims or making a false record or statement in order to secure payment by the federal
government. Actions which violate another law in this section may also result in liability under the Federal False Claims
Act as a result of the submission of claims pursuant to a prohibited arrangement. In addition to actions initiated by the
government itself, the statute authorizes actions to be brought on behalf of the federal government by a private party having
knowledge of the alleged fraud sometimes referred to as a “whistleblower”.
Because the complaints are initially filed under seal, the action may be pending for some time before the defendant
is even aware of the action. If the government is ultimately successful in obtaining redress in the matter or if the private
party plaintiff succeeds in obtaining redress without the government’s involvement, then the private party plaintiff will
receive a percentage of the recovery. Violation of the federal False Claims Act may result in fines of up to three times the
actual damages sustained by the government, plus mandatory civil penalties of up to approximately $22,363 for each
separate false claim, imprisonment or both, and possible exclusion from Medicare or Medicaid. The penalties will continue
to be adjusted, increasing each year to reflect changes in the inflation rate, pursuant to the 2015 Bipartisan Budget Act.
In October of 2018, the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, was passed as part of the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act
(referred to as the SUPPORT Act). Similar to the federal Anti-Kickback statute, EKRA creates criminal penalties for
knowing or willful payment or offer, or solicitation or receipt, of any remuneration, whether directly or indirectly, overtly
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or covertly, in cash or in kind, in exchange for the referral or inducement of laboratory testing unless a specific exception
applies. Unlike the federal Anti-Kickback Statute, EKRA is not limited to government health care benefit programs, so
the prohibitions extend to services covered by commercial health plans. Additionally, most of the safe harbors available
under the federal Anti-Kickback Statute are not reiterated under EKRA, and certain EKRA safe harbors conflict with the
safe harbors available under the federal Anti-Kickback Statute. Therefore, compliance with a federal Anti-Kickback safe
harbor does not guarantee protection under EKRA. As currently drafted, EKRA potentially expands the universe of
arrangements that could be subject to government enforcement under federal fraud and abuse laws. Violation of EKRA
carries potential penalties of up to $200,000 in fines and imprisonment of up to 10 years for each occurrence. Because
EKRA is a new law, there is very little additional guidance to indicate how and to what extent it will be interpreted, applied
and enforced by the government. Currently, there is no proposed regulation interpreting or implementing EKRA, nor any
public guidance released by a federal agency concerning EKRA. We cannot assure you that our relationships with
physicians, sales representatives, hospitals or customers will not be subject to scrutiny or will survive regulatory challenge
under EKRA. If imposed for any reason, sanctions under EKRA could have a negative effect on our business.
We are also subject to a federal law directed at “self-referrals,” commonly known as the Stark Law, which
prohibits, with certain exceptions, payments made by a laboratory to a physician in exchange for the referral of clinical
laboratory services, or presenting or causing to be presented claims to Medicare and Medicaid for laboratory tests referred
by physicians who personally, or through a family member, have an investment interest in, or a compensation arrangement
with, the clinical laboratory performing the tests. A person who engages in a scheme to circumvent the Stark Law’s referral
prohibition may be fined up to $100,000 for each such arrangement or scheme. In addition, any person who presents or
causes to be presented a claim to the Medicare or Medicaid programs in violation of the Stark Law is subject to civil
monetary penalties of up to $15,000 per claim submission, an assessment of up to three times the amount claimed, and
possible exclusion from participation in federal governmental payer programs. Claims submitted in violation of the Stark
Law may not be paid by Medicare or Medicaid, and any person collecting any amounts with respect to any such prohibited
claim is obligated to refund such amounts. Actions which violate the Stark Law may be bootstrapped to involve liability
under the Federal False Claims Act.
Many states, including California, also have state “physician self-referral” prohibitions and other laws that are
not limited to Medicare and Medicaid referrals, with which we must comply. We are subject to California’s Physician
Ownership and Referral Act, or PORA, which generally prohibits us from billing a patient or any governmental or private
payer for any laboratory services when the physician ordering the service, or any member of such physician’s immediate
family, has a “financial interest” with us, unless the arrangement meets an exception (CA Business and Professions Code
Section 650.02). The term “financial interest” is defined broadly and includes any type of ownership interest, debt, loan,
lease, compensation, remuneration, discount, rebate, refund, etc. between the ordering physician and the entity receiving
the referral. The exceptions to PORA track certain of the Stark Law exceptions, including an exception for personal service
arrangements and for ownership of publicly traded entities. A violation of PORA is punishable by civil and criminal
penalties (civil penalties and criminal fines vary depending on the nature of the violation, but may reach up to $15,000 per
violation).
Other states may have self-referral restrictions with which we have to comply that differ from those imposed by
federal and California law.
We are also subject to applicable state client billing laws, which specify whether a person that did not perform
the service is permitted to submit the claim for payment and if so, whether the non-performing person is permitted to mark
up the cost of the services in excess of the price the purchasing provider paid for such services. California has an anti-
markup statute with which we must comply, which prohibits providers from charging for any laboratory test that it did not
perform unless the provider (a) notifies the patient, client or customer of the name, address, and charges of the laboratory
performing the test, and (b) charges no more than what the provider was charged by the clinical laboratory which performed
the test except for any other service actually rendered to the patient by the provider (for example, specimen collection,
processing and handling) (Business and Professions Code Section 655.5). This provision applies, with certain limited
exceptions, to licensed persons such as physicians and clinical laboratories regulated under the Business and Professions
Code. A violation of this provision can lead to imprisonment and/or a fine of up to $10,000. Other states have similar anti-
markup prohibitions with which we must comply. In addition, many states also have “direct-bill” laws, which means that
29
the services actually performed by an individual or entity must be billed by such individual or entity, thus preventing
ordering physicians from purchasing services from a laboratory and rebilling for the services they order. For example,
California has a direct bill rule specific to anatomic pathology services that prohibits any provider from billing for anatomic
pathology services if those services were not actually rendered by that person or under his or her direct supervision with
some exemptions (CA Business and Professions Code Section 655.7).
While we have attempted to comply with the federal fraud and abuse laws, California and New York fraud and
abuse laws and similar laws of other states and non-U.S. jurisdictions, it is possible that some of our arrangements could
be subject to regulatory scrutiny at some point in the future, and we cannot provide assurance that we will be found to be
in compliance with these laws following any such regulatory review.
Further, in addition to the privacy and security regulations stated above, HIPAA created two federal crimes:
healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and
willfully executing a scheme to defraud any healthcare benefit program, including private payers. A violation of this statute
is a felony and may result in fines, imprisonment or exclusion from government sponsored programs. The false statements
statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially
false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or
services. A violation of this statute is a felony and may result in fines or imprisonment.
Finally, federal law prohibits any entity from offering or transferring to a Medicare or Medicaid beneficiary any
remuneration that the entity knows or should know is likely to influence the beneficiary’s selection of a particular provider,
practitioner or supplier of Medicare or Medicaid payable items or services, including waivers of copayments and
deductible amounts (or any part thereof), if any apply, and transfers of items or services for free or for other than fair
market value. Entities found in violation may be liable for civil monetary penalties of up to $100,000 for each wrongful
act. Although we believe that our business activities and practices, including our sales and marketing practices, are in
material compliance with all applicable federal and state laws and regulations, relevant regulatory authorities may disagree,
and violation of these laws or our exclusion from such programs as Medicare, Medicaid and other federal health care
programs as a result of a violation of such laws could have a material adverse effect on our business, results of operations,
financial condition and cash flows.
Employees
As of December 31, 2019, we had 1,039 employees. We also engage consultants and temporary employees. We
have not been subject to labor action or union activities, and our management considers its relationships with employees
to be good.
Glossary of Terms
ACOG – the American Congress of Obstetricians and Gynecologists.
ACMG – the American College of Medical Genetics and Genomics.
Allograft – the transplant of an organ or tissue from one individual to another individual of the same species who is not
genetically identical.
AMA – American Medical Association.
AUC – area under the receiver operating curve; a measure of the diagnostic performance of a test, based on sensitivity and
specificity.
CLIA – Clinical Laboratory Improvement Amendments.
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CMS – Centers for Medicare and Medicaid Services.
CNV – copy number variation; a genetic mutation in which relatively large regions of the genome have been deleted or
duplicated.
CPT – Current Procedure Terminology.
ctDNA – circulating tumor DNA; tumor DNA circulating in a blood sample.
CS test – carrier screening test.
dd-cfDNA – donor-derived cell-free DNA; DNA that is shed from a transplanted organ undergoing rejection.
DNA – deoxyribonucleic acid.
Fetal aneuploidy – an inherited genetic condition in which a fetus has a different number of chromosomes than are typical.
Gene fusion – an abnormality in which DNA segments from two different genes are exchanged, forming one fused gene.
Gene fusions have been implicated in the development of cancer tumors.
HPC – hematopoietic progenitor cells.
ISPD – the International Society for Prenatal Diagnosis.
IVD – in vitro diagnostic; tests that can be used in any laboratory that has the appropriate qualifications and authorizations.
IVF – in vitro fertilization.
LDT – laboratory developed test; tests that are designed, developed, validated and used within a single laboratory.
MFM – maternal fetal medicine.
Microdeletion – a deletion of a region of DNA from one copy of one chromosome.
Micro-metastatic disease – a subclinical disease state in which small numbers of cancer cells have spread from the primary
tumor to other parts of the body and are too few to be picked up in a screening or diagnostic test.
mmPCR – massively multiplexed polymerase chain reaction.
NGS – next-generation sequencing; a DNA sequencing technology.
No-call – the inability to update the prior risk, or the standard risk assigned based on maternal and gestational age, in order
to provide a high-risk or low-risk test result due to insufficient information in the sample.
PPV – positive predictive value; the likelihood that a positive result on a test indicates a true positive result in the patient.
Sensitivity – the likelihood that an individual with a condition will be correctly found to have that condition. Sensitivity is
calculated as the ratio between the number of individuals that test positive for the condition over the total number of
individuals in the tested cohort who actually have the condition.
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Signal to noise ratio – the ratio of useful information to irrelevant data.
SMFM – the Society for Maternal Fetal Medicine.
SNP – single nucleotide polymorphism; a position on the chromosome at which single DNA base changes are common in
the population.
SNV – single nucleotide variant; a genetic mutation in which a single chemical base in DNA has changed.
Specificity – the likelihood that an individual without a condition will be correctly found not to have that condition.
Specificity is calculated as the ratio between the number of individuals that test negative for a condition over the total
number of individuals in the tested cohort who do not have the condition.
Triploidy – a type of fetal aneuploidy in which an individual has three copies of every chromosome instead of two.
Corporate Information
We were initially formed in California as Gene Security Network, LLC in November 2003. We were incorporated
in Delaware in January 2007, and we changed our name to Natera, Inc. in January 2012. Our principal executive offices
are located at 201 Industrial Road, Suite 410, San Carlos, California 94070, and our telephone number is (650) 249-9090.
Our website address is www.natera.com. We do not incorporate the information on, or accessible through, our website
into this annual report on Form 10-K, and you should not consider any information on, or accessible through, our website
as part of this annual report on Form 10-K.
Available Information
We make available on our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of
the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission, or SEC, as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Copies of our reports on
Form 10-K, Form 10-Q and Form 8-K, may be obtained, free of charge, electronically through our internet website,
http://investor.natera.com. Additionally, the SEC maintains an internet site that contains reports, proxy and information
statements and other information. The address of the SEC’s website is www.sec.gov. The information found on our website
is not incorporated by reference into this report or any other report we file or furnish to the SEC.
ITEM 1A.
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should consider carefully the risks and
uncertainties described below, together with all of the other information in this report, including the section titled
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated
financial statements and related notes, before investing in our common stock. The risks and uncertainties described below
are not the only ones we face. If any of the following risks actually occurs, our business, financial condition, results of
operations and prospects could be materially and adversely affected. In that event, the price of our common stock could
decline and you could lose part or all of your investment.
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Risks Related to Our Business and Industry
We derive the significant majority of our revenues from Panorama and Horizon, and if our efforts to further increase
the use and adoption of Panorama and Horizon or to develop new products and services in the future do not succeed,
our business will be harmed.
Historically, including for each of the years ended December 31, 2019 and 2018, a significant portion of our
revenues were derived from sales of our Panorama NIPT. Sales of our Horizon carrier screening test also contributed
significantly to our revenues. We expect to continue to derive the majority of our revenues from the sales of Panorama
and Horizon. With respect to Panorama in particular, continued and additional market demand for Panorama, and
reimbursement for the average risk population and for microdeletions, are key elements to our future success. The market
demand for NIPTs and carrier screening tests continue to evolve. We cannot guarantee that physicians will recommend
and order Panorama or Horizon, and our laboratory distribution partners and licensees may not actively or effectively
market Panorama or Horizon.
Our ability to increase sales and establish significant levels of adoption and reimbursement for Panorama and
Horizon is uncertain, and it may be challenging for us to achieve profitability for many reasons, including, among others:
•
•
•
•
•
the market for our tests may not grow as we expect; in particular, NIPTs may not gain acceptance for use in
the average-risk pregnancy population or as a screen for microdeletions, which would limit the market for
Panorama, and we may fail to compete successfully in this market, whatever size;
if we are unable to demonstrate that our tests are superior to competing tests, laboratories, clinics,
clinicians, physicians, payers and patients may not adopt use of Panorama, Horizon or our other tests on a
broad basis, and may not be willing to pay the price premium over competing tests that we have, to date,
been able to achieve;
third-party payers, such as commercial insurance companies and government insurance programs, may
decide not to reimburse for Panorama, may not reimburse for uses of Panorama for the average-risk
pregnancy population or for the screening of microdeletions, or may set the amounts of such
reimbursements at prices that do not allow us to cover our expenses; in fact, many third-party payers
currently have negative coverage determinations or otherwise do not reimburse for average-risk patient
populations or for microdeletions screening and we expect low reimbursement rates for microdeletions
screening to continue, at least in the near term; also, most state Medicaid programs currently either
reimburse at low rates or do not reimburse for our tests;
third-party payers have increasingly required that prior authorization be obtained prior to conducting
genetic testing as a condition to reimbursing for it, which has reduced and/or delayed the reimbursement
amounts we receive for Panorama, Horizon and our other tests;
the results of our clinical trials and any additional clinical and economic utility data that we may develop,
present and publish or that comes from the commercial use of our tests may be inconsistent with prior data,
may raise questions about the performance of our tests, or may fail to convince laboratories, clinics,
clinicians, physicians, payers or patients of the value of our tests; furthermore, we may be unable to
achieve stable reimbursement for microdeletions unless and until sufficient validation data on the
sensitivity and specificity of our test for these conditions become available, which may take longer than we
anticipate;
• we may experience supply constraints, including those due to the failure of our key suppliers to provide
required sequencers and reagents in sufficient amounts or of adequate quality or disputes with our key
suppliers, including those with respect to the required sequencers and reagents from our supplier,
Illumina, Inc., or Illumina, who is also one of our main NIPT competitors through its subsidiary, Verinata
Health Inc., or Verinata, and with whom we are currently involved in patent litigation as further described
33
in “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to Consolidated Financial
Statements;
• we may experience increased cost of product revenues, and cost of licensing and other revenues, as a
percentage of total revenues, as has been the case in previous fiscal years;
•
•
the U.S. Food and Drug Administration, or the FDA, or other U.S. or foreign regulatory or legislative
bodies may adopt new regulations or policies, or take other actions that impose significant restrictions on
our ability to market and sell Panorama, Horizon or our other tests, including requiring FDA clearance or
approval for the sale of Panorama or Horizon or of the sequencers, reagents, kits and other consumable
products that we purchase from third parties in order to perform our testing;
our laboratory partners may choose to develop their own tests that are competitive with ours or offer tests
provided by our competitors due to pricing or other reasons as has happened in the past, or otherwise fail to
effectively market our tests; and competitors may develop and commercialize more effective and/or less
expensive tests that deliver comparable results as our tests;
• we may fail to adequately protect or enforce our intellectual property relating to our tests, leading to
increased competition; or other parties may claim that the practice of our technology by us or our licensees
and collaborators infringes such other party’s intellectual property rights, as each of Illumina and CareDX,
Inc. have done in lawsuits filed against us, as discussed further in “Note 8—Commitments and
Contingencies—Legal Proceedings” in the Notes to Consolidated Financial Statements; if we are required
to pay license fees in order to license third-party intellectual property rights due to actual or alleged
infringement based on our running our tests, we may experience increased costs in running our tests, and
we may be unable to pass such costs on to our customers;
• we may be unable to dedicate adequate resources to the maintenance and further technological
advancement of Panorama and Horizon that are necessary for such tests to be competitive in the
marketplace because of the demands placed on our research and development and product teams with
respect to our other products and programs, including our Signatera and Prospera tests;
•
in the event that it is in our commercial or financial interest or we are forced to transition sequencing
platforms for Panorama, we may be unable to do so in a commercially sustainable way and that could
survive claims of infringement of intellectual property rights of Illumina and other competitors, in a timely
manner or at all; and
• we may not be successful in commercializing our cloud-based distribution model.
If the market for Panorama or Horizon, or our market share for either test, fail to grow or grow more slowly
than expected, our business, operating results and financial condition will be harmed.
We have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable
future, which could harm our future business prospects.
We have incurred net losses each year since our inception in 2003. To date, we have financed our operations
primarily through private placements of preferred stock, convertible debt and other debt instruments, our initial public
offering and our registered public equity offerings. Our net loss for the years ended December 31, 2019, 2018 and 2017
was, respectively, $124.8 million, $128.2 million and $137.6 million. As of December 31, 2019, we had an accumulated
deficit of $699.2 million. Such losses may continue to increase in the future as we continue to devote a substantial portion
of our resources to efforts to increase the adoption of, and reimbursement for, Panorama, Horizon and our other products,
improve these products, and research and develop and commercialize new products, which increasingly are in industries
that are new to us, such as oncology and transplant rejection.
In addition, the rate of growth in our revenues has fluctuated in recent periods, and may continue to do so in
future periods. In particular, such rate of growth may be negative, low or flat, including if the rate of growth of our test
volumes slows. A significant element of our business strategy is to maintain increased in-network coverage with
34
third-party payers; however, the negotiated fees under our contracts with third-party payers are typically lower than the
list price of our tests, and in some cases the third-party payers that we contract with have negative coverage
determinations for some of our offerings, in particular Panorama for the average-risk pregnancy population and for
microdeletions screening. Therefore, being in-network with third-party payers has had, and may continue to have, an
adverse impact on our revenues especially if we are unable to increase the adoption of, and obtain favorable coverage
determinations for reimbursement for, our products. Furthermore, a CPT code for microdeletions went into effect
beginning January 1, 2017. We have experienced low average reimbursement rates for microdeletions testing under this
code, and we expect that this code will continue to cause our microdeletions reimbursement to remain low, at least in the
near term, either due to reduced reimbursement, or third-party payers declining to reimburse, under the microdeletions
code, which has had and will likely continue to have an adverse effect on our revenues. In addition, a new CPT code for
expanded carrier screening went into effect beginning January 1, 2019, and has had, and may continue to have, an
adverse effect on our reimbursement rates for our broader Horizon carrier screening panel, for which we previously
primarily received reimbursement on a per-condition basis, as those tests may be reimbursed as a combined single panel
instead of as multiple individual tests.
As further discussed in the risk factor entitled “—We may not be successful in commercializing our cloud-based
distribution model,” our results of operations may be adversely affected if we do not sell a sufficient volume of tests under
our cloud-based distribution model to offset the lower revenues per test performed under that model. Our ability to forecast
our future operating results, including revenues, cash flows and profitability, is limited and subject to a number of
uncertainties. We have also encountered and will continue to encounter risks and uncertainties frequently experienced by
growing companies in the life sciences and technology industry, such as those described in this report. If our assumptions
regarding these risks and uncertainties are incorrect or these risks and uncertainties change, or if we do not address these
risks successfully, our operating and financial results may differ materially from our expectations, and our business may
suffer.
Uncertainty in the development and commercialization of our enhanced or new tests or services could materially
adversely affect our business, financial condition and results of operations.
Our success will depend in part on our ability to effectively introduce enhanced or new offerings. The focus of
our research and development efforts have expanded beyond reproductive health products, as we are now also applying
our expertise in processing and analyzing cell-free DNA in the fields of cancer monitoring and transplant rejection. In
recent years we have developed and/or launched several new products or enhanced versions of existing products,
including our first offerings in oncology and in organ transplantation, and we expect to continue our efforts in all of
these areas. The development and launch of enhanced or new tests requires the completion of certain clinical
development and commercialization activities that are complex, costly, time-intensive and uncertain, and requires us to
accurately anticipate patients’, clinicians’, payers’ and other counterparties’ attitudes and needs as well as emerging
technology and industry trends. This process is conducted in various stages, and each stage presents the risk that we will
not achieve our goals.
We have limited experience developing and commercializing cell-free DNA tests outside of the reproductive
health space, and we may not be successful in our current or future efforts to do so. We also have limited experience
forecasting our future financial performance from our new products, including non-NIPT types of cell-free DNA tests,
and our actual results may fall below our financial guidance or other projections, or the expectations of analysts or
investors, which could cause the price of our common stock to decline. We may experience research and development,
regulatory, marketing and other difficulties that could delay or prevent our introduction of enhanced or new tests and
result in increased costs and the diversion of management’s attention and resources from other business matters, such as
from our Panorama and Horizon product offerings, which currently represent the significant majority of our revenues.
For example, any tests that we may enhance or develop may not prove to be clinically effective in clinical trials or
commercially, or may not meet our desired target product profile, be offered at acceptable cost and with the sensitivity,
specificity and other test performance metrics necessary to address the relevant clinical need or commercial opportunity;
our test performance in commercial experience may be inconsistent with our validation or other clinical data; we may
not be successful in achieving market awareness and demand, whether through our own sales and marketing operations
or through collaborative arrangements; healthcare providers may not order or use, or third-party payers may not
reimburse for, any tests that we may enhance or develop; or we may otherwise have to abandon a test or service in which
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we have invested substantial resources. In particular, we are subject to the risk that the biological characteristics of the
genetic mutations we seek to target, and upon which our technologies rely, are uncertain and difficult to predict. For
example, in our efforts to detect and analyze circulating tumor DNA in plasma for MRD assessment and recurrence
surveillance, our success depends on tumors shedding mutant DNA into the bloodstream in sufficient quantities such that
our technology can detect such mutations. As further discussed in the risk factor entitled “If our products do not perform
as expected, our operating results, reputation and business will suffer,” we may also experience unforeseen difficulties
when implementing updates to our processes, as we have occasionally experienced with Panorama and with Horizon, for
which we launched a new workflow in 2018.
We cannot assure you that we can successfully complete the clinical development of any new or enhanced
product, or that we can establish or maintain the collaborative relationships that may be essential to our clinical
development and commercialization efforts. Clinical development requires large numbers of patient specimens and, for
certain products, may require large, prospective, and controlled clinical trials. We may not be able to enroll patients or
collect a sufficient number of appropriate specimens in a timely manner; or we may experience delays during clinical
development due to slower than anticipated enrollment, which we experienced in the past with our SNP-based
Microdeletions and Aneuploidy RegisTry (SMART) study, or due to changes in study design or other unforeseen
circumstances, such as our decision to expand our SMART study to include a larger number of patients; or we may be
unable to afford or manage the large-sized clinical trials that some of our planned future products may require. The data
collected from any studies we complete may not be favorable or consistent with our existing data or may not be
statistically significant or compelling to the medical community or to third-party payers seeking such data for purposes
of determining coverage for our tests. This is particularly true with respect to testing in the average-risk pregnancy
population and for microdeletions screening using our Panorama test. For example, in January 2017 we published data
from our DNAFirst study showing that NIPT can be effectively and appropriately offered as a primary screen for all
pregnant women regardless of risk due to maternal age or other factors; however, it remains uncertain whether or to what
extent it will impact coverage or adoption of Panorama in the average-risk population.
The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining
reimbursement for tests such as ours, and our inability to control when, if ever, results are published may delay or limit
our ability to derive sufficient revenues from any test that is the subject of a study. Peer-reviewed publications regarding
our tests may be limited by many factors, including delays in the completion of, poor design of, or lack of compelling
data from, clinical studies, as well as delays in the review, acceptance and publication process. If our tests or the
technology underlying our current tests or future tests do not receive sufficient favorable exposure in peer-reviewed
publications, the rate of clinician adoption of our tests and positive reimbursement coverage determinations for our tests
could be negatively affected.
In addition, as further described in the risk factor entitled “—If the FDA were to begin actively regulating our
tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and
incur costs associated with complying with post-market controls,” development of the data necessary to obtain
regulatory clearance and approval of a test is time-consuming and carries with it the risk of not yielding the desired
results. The performance achieved in published studies may not be repeated in later studies that may be required to
obtain FDA premarket clearance or approval or regulatory approvals in foreign jurisdictions. Limited results from
earlier-stage verification studies may not predict results from studies in larger numbers of subjects drawn from more
diverse populations over longer periods of time. Unfavorable results from ongoing preclinical and clinical studies could
result in delays, modifications or abandonment of ongoing analytical or future clinical studies, or abandonment of a
product development program, or may delay, limit or prevent regulatory approvals or clearances or commercialization of
our product candidates, which could have a material adverse effect on our business, operating results or financial
condition.
These and other factors beyond our control could result in delays or other difficulties in the research and
development, approval, production, launch, marketing or distribution of enhanced or new tests and could adversely
affect our competitive position and results of operations.
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Our quarterly results may fluctuate from period to period, which could adversely impact the value of our common
stock.
Our quarterly results of operations, including our revenues, gross margin, net loss and cash flows, may vary
from period to period as a result of a variety of factors, many of which are outside of our control, including those listed
elsewhere in this “Risk Factors” section, and as a result, period-to-period comparisons of our operating results may not
be meaningful. Our quarterly results should not be relied upon as an indication of future performance. In addition, to the
extent that we continue to spend considerably on our internal sales and marketing and research and development efforts,
we expect to incur costs in advance of achieving the anticipated benefits of such efforts. Fluctuations in quarterly results
and key metrics may cause our results to fall below our financial guidance or other projections, or the expectations of
analysts or investors, which could cause the price of our common stock to decline. We also face competitive pricing and
reimbursement pressures, and we may not be able to maintain our premium pricing in the future, which would adversely
affect our operating results.
Competition in our industry is intense; if we are unable to compete successfully with respect to our current or future
products or services, we may be unable to increase or sustain our revenues or achieve profitability.
We compete primarily in the molecular testing field, which is characterized by rapid technological changes,
frequent new product introductions, reimbursement challenges, emerging competition, intellectual property disputes and
litigation, price competition, aggressive marketing practices, evolving industry standards and changing customer
preferences. Our principal competition in reproductive health comes from existing testing methods, technologies and
products that are used by OB/GYNs, MFM specialists or IVF centers. These include other NIPTs and carrier screening
tests offered by our competitors, as well as established, traditional first-line prenatal screening methods, such as serum
protein measurement, where doctors measure certain hormones in the blood, and invasive prenatal diagnostic tests like
amniocentesis, which have been used for many years and are therefore difficult to displace or supplement. In addition,
new testing methods may be developed which may displace or be preferred over NIPTs, such as whole genome
sequencing or single cell analysis. We are new to the fields of oncology and organ transplantation, and face competition
in these business areas from other companies, many of which are larger, more established and have more experience and
more resources than we do. Some of our competitors in the liquid biopsy field, in which clinical cancer diagnostic tests
examine blood samples rather than solid tumor samples, are expanding their research and development efforts to include
screening for other biomarkers instead of, or in addition to, ctDNA, on the basis that analyzing multiple biomarkers may
result in improved sensitivity, lower costs and earlier detection than ctDNA-based tests such as ours. We cannot assure
you that research, discoveries or other advancements by other companies will not render our existing or potential
products and services uneconomical or result in products and services that are superior or otherwise preferable to our
current or future products and services.
We compete with numerous companies in the genetic diagnostics space. Our primary competitors in NIPT
include Sequenom, which was recently acquired by LabCorp; Illumina, through its subsidiary Verinata; Ariosa, a
subsidiary of Roche; Myriad Genetics, Inc., which has acquired Counsyl, Inc; Invitae Corp.; Bio-Reference, a business
unit of OKPO Health, Inc.; Quest; Premaitha Health PLC; BGI; and Progenity. All of our main NIPT competitors in the
United States are owned or controlled by companies much larger than ours and with much greater resources for sales,
marketing and research and development efforts. Our primary competitors in carrier screening include LabCorp; Myriad
Genetics, Inc.; Invitae Corp.; Progenity; Quest; Recombine Inc.; and GenPath Diagnostics, a business unit of
Bio-Reference. In the field of ctDNA-based MRD assessment and recurrence surveillance, we face competition from
various companies that offer or seek to offer competing solutions, such as Roche Diagnostics, a division of Roche;
Guardant Health, Inc., Adaptive Biotechnologies, Personal Genome Diagnostics, Inc.; Exact Sciences Corp.; and
ArcherDX, Inc. In the field of transplant rejection, our primary competitors include CareDx, Inc. and Eurofins Viracor,
Inc. We expect that the number of competitors in these spaces will continue to increase.
Some of our competitors’ products and services are sold at a lower price than ours, which could cause sales of
our tests and services to decline or force us to reduce our prices. Our current and future competitors could have greater
technological, financial, reputational and market access advantages than us, and we may not be able to compete
effectively against them. Increased competition is likely to result in pricing pressures, which could harm our revenues,
operating income or market share. We are increasingly subject to litigation with our competitors; for example, as
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disclosed elsewhere in these Risk Factors and Report, we are in active litigation with competitors in each of the
reproductive health, oncology and organ transplantation fields, which involve considerable costs to us as well as
management time and attention. If we are unable to compete successfully, we may be unable to increase or sustain our
revenues or achieve profitability.
We may not be successful in commercializing our cloud-based distribution model.
We utilize a cloud-based distribution model to deploy our bioinformatics technology for use by other
laboratories. Under this model, clinical laboratories around the world, including in the U.S., license our technology to
develop and run their own NIPT or other molecular testing assays in their own facilities as LDTs, and then access our
proprietary algorithms through our cloud-based Constellation software to analyze the assay results. In the diagnostics
industry, the market for cloud-based solutions and services is not as mature as the market for on-premise enterprise
software, and it remains uncertain whether and to what extent our cloud-based distribution model will achieve and
sustain high levels of customer demand and market acceptance. As of February 1, 2020, only 13 licensees are using
Constellation commercially to market NIPT products and one licensee is using Constellation commercially to market its
non-invasive prenatal paternity test in the United States and internationally. The rate of adoption of our cloud-based
distribution model continues to be slower than we anticipated, and depends on a number of factors, including the cost,
performance and perceived value associated with our solution, as well as our ability to address security, privacy and
regulatory requirements or concerns. In particular, all of our licensees under our cloud-based distribution model are
required to use Illumina sequencers and reagents to run their tests that they develop based on our technology. As further
described in the risk factor entitled “—We rely on a limited number of suppliers or, in some cases, single suppliers, for
some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to
alternative suppliers,” we are aware that Illumina has required our licensees to pay an additional license fee in certain
jurisdictions in order to secure a supply agreement for the sequencers and reagents necessary to run NIPT under our
cloud-based distribution model. Furthermore, Illumina competes with us through its subsidiary Verinata, and may not
charge a similar license fee for Verinata’s licensed-based offering to other laboratories. As a result, our potential or
current licensees may be unable to commercially launch their tests under our cloud-based distribution model in a
financially viable manner, which has dissuaded and could continue to dissuade potential or current licensees from
licensing from us or launching a test based on our technology. In addition, if a test developed by any of our licensees
under our cloud-based distribution model in the United States is found not to be an LDT, the licensee may not be able to
market its test, and we would not receive the anticipated revenues from that licensee.
We also do not know whether, over the long term, this model will result in benefits or cost savings at the levels
that we anticipate or at all. For example, to the extent that any of our laboratory customers for whom we currently
perform our tests entirely in our laboratory transition to our cloud-based distribution model, our revenues from such
customers will decrease because we are not able to charge as high an amount per test as when we perform the entire test
ourselves. If the lower revenues per test performed is not offset by a sufficient increase in volume of tests sold, our
overall revenues will be lower, and our results of operations may be adversely affected.
Among the risks to our business and results of operations from our Constellation model are the following:
•
•
our and our licensees’ ability to obtain required regulatory authorizations from the FDA and international
regulatory agencies as further described in the risk factor entitled “Reimbursement and Regulatory Risks
Related to Our Business—Failure to obtain necessary regulatory approvals may adversely affect our
ability to expand our operations internationally, including our ability to continue commercializing our
cloud-based distribution model;”
supply constraints, including with respect to the blood collection tubes that are used for our Panorama test
and that are supplied by Streck, Inc., as further described in the risk factor entitled “—We rely on a limited
number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and
materials and may not be able to find replacements or immediately transition to alternative suppliers;”
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•
•
•
allegations or potential third-party claims that the tests, based on our technology, developed by our
licensees violate such third parties’ intellectual property rights in the territories in which our licensees
commercialize their tests;
licensing portions of our proprietary technology to third parties that may not take the same security
precautions as we do to protect this information; and
an inability to achieve anticipated benefits and costs savings.
If we or other cloud-based solution providers experience security incidents, loss of customer data or disruptions
in delivery or other problems, the market for cloud-based solutions in the diagnostics industry, including our solutions,
may be adversely affected. Such events could also result in potential lawsuits and liability claims, which could have a
material adverse effect on our business. If there is a reduction in demand for cloud-based solutions caused by
technological challenges, weakening economic conditions, security or privacy concerns, competing technologies and
products or other challenges, we may not be successful in executing our Constellation business model, and our results of
operations may be adversely affected.
We may be subject to increased compliance risks as a result of our rapid growth, including our dependence on our
sales, marketing and billing efforts.
Approximately 80% of our total revenues for the year ended December 31, 2019 were attributable to our U.S.
direct sales. We have had to expand our training and compliance efforts in line with our increasing reliance on personnel
in our sales, marketing and billing functions, and our expansion of these functions in line with the overall growth in our
business. We continue to monitor our personnel, but we have in the past experienced, and may in the future experience,
situations in which employees fail to strictly adhere to our policies. In addition, sales and marketing activities in the
healthcare space are subject to various rules and regulations, as described in the risk factor entitled “—Reimbursement
and Regulatory Risks Related to Our Business—If we or our laboratory distribution partners, consultants or commercial
partners act in a manner that violates healthcare fraud and abuse laws or otherwise engage in misconduct, we may be
subject to civil or criminal penalties;” moreover, our billing and marketing messaging can be complex and nuanced, and
there may be errors or misunderstandings in our employees’ communication of such messaging. Furthermore, we utilize
text messaging, email, phone calls and other similar methods to communicate with patients who are existing or potential
users of our products for various business purposes. These activities subject us to laws and regulations relating to
communications with consumers, such as the CAN-SPAM Act and the Telephone Consumer Protection Act, violations
of which could subject us to claims by consumers, who may seek actual or statutory damages, which could be material in
the aggregate. As described further in “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to
Consolidated Financial Statements, a purported class action lawsuit has been filed against us, alleging that we sent an
unauthorized text message to a plaintiff’s cellular telephone. As we continue to scale up our sales and marketing efforts
in line with the growth in our business, in particular our increased pace of product launches as well as further
geographical expansion—for example our agreement with a transplant diagnostics company to co-market our Prospera
test in conjunction with our direct sales force—we face an increased need to continuously monitor and improve our
policies, processes and procedures to maintain compliance with a growing number and variety of laws and regulations,
including with respect to consumer marketing. To the extent that there is any violation, whether actual, perceived or
alleged, of our policies or applicable laws and regulations, we may incur additional training and compliance costs, may
receive inquiries from third-party payers or other third parties, or be held liable or otherwise responsible for such acts of
non-compliance. Any of the foregoing could adversely affect our cash flow and financial condition.
We rely on internal and third-party data centers and platforms to host our laboratory and cloud-based software, and
any interruptions of service or failures may impair our laboratory operations or the delivery of our cloud-based
services and harm our business.
We currently maintain a data center at our laboratory facilities in San Carlos, California. In addition, our
proprietary bioinformatics algorithms are a crucial component of our test processing, and combine information derived
from our mmPCR assay workflows with publicly available data from the broader scientific community to analyze and
return test results. We host the significant majority of these algorithms on a cloud-based software platform pursuant to an
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agreement with DNAnexus, Inc., or DNAnexus, and both we and our Constellation licensees access our algorithms
through the DNAnexus platform. The DNAnexus platform is hosted on third-party data center hosting facilities operated
by Amazon Web Services, or AWS, located primarily in the United States and in the European Union. These algorithms
cannot currently be run other than through the DNAnexus platform; they are currently used to run our Panorama NIPT
and NIPT analysis for our Constellation licensees, as well as Horizon, Signatera, Prospera and certain of our research
and development activities, and we plan to utilize the platform for additional applications in the future. In the event of
any technical problems that may arise in connection with our on-site data center, the DNAnexus platform or the AWS
servers on which the DNAnexus platform is hosted, or difficulties in or termination of our relationship with DNAnexus,
we could experience interruptions in our laboratory operations or our cloud-based services, and we and our Constellation
licensees may be unable to access our proprietary algorithms and therefore be unable to process tests or conduct any
other activities that require access to such algorithms. We do not have any backup platform, server or other means to
host our algorithms, and may be unable to find and implement an alternative platform that is satisfactory for our needs
on commercially reasonable terms, in a timely manner, or at all. These types of problems may be caused by a variety of
factors, including infrastructure changes, human or software errors, viruses, security attacks, fraud, spikes in customer
usage and denial of service issues. Interruptions in our operations or service may reduce our revenue, cause us to issue
refunds, result in the loss of customers, cause laboratory licensees to terminate their contracts with us, adversely affect
our ability to attract new laboratory licensees, or harm our reputation. We could also be exposed to potential lawsuits and
liability claims.
If our products do not perform as expected, our operating results, reputation and business will suffer.
Our success depends on the market’s confidence that we can provide reliable, high-quality testing results, in the
reproductive health space as well as in oncology and transplant rejection. There is no guarantee that the accuracy and
reproducibility we have demonstrated to date will continue as our test volumes increase and our product portfolio
expands. We believe that our customers are particularly sensitive to test limitations and errors, including inaccurate test
results and the need on occasion to perform second blood draws, or redraws, on patients, for which Panorama
experiences a higher rate than advertised for other NIPTs. As a result, if our tests do not perform as expected or
favorably in comparison to competitive tests, our operating results, reputation, and business will suffer. We may be
subject to legal claims arising from such limitations, errors, or inaccuracies.
Panorama, Horizon and our other products use a number of complex and sophisticated biochemical and
bioinformatics processes, many of which are highly sensitive to external factors. An operational, technological or other
failure in one of these complex processes or fluctuations in external variables may result in sensitivity or specificity rates
that are lower than we anticipate or that vary between test runs, a higher than anticipated number of tests that require
redraws or fail to produce results, or longer than expected turnaround times, which we have experienced and will likely
continue to experience on occasion as a result of issues with laboratory equipment, components or materials or
otherwise. In addition, we regularly evaluate and refine our testing processes, and any refinements we make may not
improve our tests as we expect and may result in unanticipated issues that may adversely affect our test performance as
described above. For example, we experienced longer than expected turnaround times following the implementation of a
significantly updated Horizon workflow in 2018. Such operational, technical and other difficulties adversely affect test
performance, may impact the commercial attractiveness of our products, and may increase our costs or divert our
resources, including management’s time and attention, from other projects and priorities. Furthermore, any changes to
our testing process may require us to use new or different suppliers or materials with whom or which we are unfamiliar,
and which may not perform as we anticipate, and could cause delays, downtime or other operational issues.
In addition, as further discussed in the risk factor entitled “If we are unable to successfully grow revenues for
our current or future products or services in addition to Panorama, our business and results of operations may be
adversely affected,” our Vistara NIPT is a relatively new test offering, as are Signatera and Prospera. Any failure to meet
consumer expectations could harm our reputation.
We rely on third-party laboratories to perform portions of our service offerings.
We and our subsidiaries outsource the portions of testing that we do not perform in-house to third-party CLIA
certified laboratories. For example, a portion of our Horizon carrier screening testing and our Vistara single-gene
mutations testing is performed by third-party laboratories. These third-party laboratories are subject to contractual
obligations to perform these services for us, but are not otherwise under our control. We therefore do not control the
capacity and quality control efforts of these third-party laboratories other than through our ability to enforce contractual
40
obligations on volume and quality systems, and we have no control over such laboratories’ compliance with applicable
legal and regulatory requirements. We also have no control over the timeliness of such laboratories’ performance of their
obligations to us, and third-party laboratories that we have contracted with have in the past had, and occasionally
continue to have, issues with delivering results to us or resolving issues with us within the time frames we expected or
established in our contracts with them, which sometimes results in longer than expected turnaround times for, or
negatively impacts the performance of, these tests and services. We may not have sufficient alternative backup if one or
more of the third-party laboratories that we contract with are unable to satisfy their obligations to us with sufficient
performance, quality and timeliness. Any natural or other disaster, acts of war or terrorism, shipping embargoes, labor
unrest or political instability or similar events at one or more of our third-party laboratories’ facilities that causes a loss
of capacity would heighten the risks that we face. Changes to or termination of our agreements or inability to renew our
agreements with these third-party laboratories or enter into new agreements with other laboratories that are able to
perform such portions of our service offerings could impair, delay or suspend our efforts to market and sell these tests
and services. In the event of any adverse developments with these third-party laboratories or their ability to perform their
obligations to us in a timely manner and in accordance with the standards that we and our customers expect, our ability
to service our customers may be delayed, interrupted or otherwise adversely affected, which could result in a loss of
customers and harm to our reputation. Furthermore, when these issues arise, we have had to expend time, management
attention and other resources to address and remedy such issues. In addition, certain third-party payers, including some
state Medicaid payers, that we are under contract with may take the position that sending out testing to third-party
laboratories and billing for such tests is contrary to the terms of our provider agreement and may refuse to pay us for the
testing. If any of these events occur, our business, financial condition and results of operations could suffer. Further,
some state laws impose anti-markup restrictions that prevent an entity from realizing a profit margin on outsourced
testing. If we or our subsidiaries are unable to markup outsourced testing, our revenues and operating margins may
suffer.
If we are unable to successfully grow revenues for our products or services in addition to Panorama and Horizon, our
business and results of operations may be adversely affected.
Our ability to successfully grow revenues for products or services in addition to Panorama and Horizon, is
uncertain and is subject to many of the risks we face with respect to Panorama and Horizon. For example, the adoption
and demand for such products or services may not grow as we expect; we may not be able to demonstrate that such
products or services are equivalent or superior to competing products or services; third-party payers may not reimburse
for our tests, or may set the amounts of such reimbursements at prices that do not allow us to cover our expenses; we
may fail to compete successfully in the relevant product markets, or our laboratory distribution partners may choose to
more actively or exclusively market tests by competitors; we may experience supply constraints; and we may fail to
adequately protect our intellectual property relating to our products or others may claim we infringe their intellectual
property rights, which has occurred, as disclosed elsewhere in these Risk factors, with respect to active litigation with
Illumina regarding Panorama and with CareDx regarding Prospera. In addition, because our revenues from Horizon now
represent a significant proportion of our overall revenues, any adverse impact we experience with respect to Horizon
could result in an impact to our overall revenues, or a component of such overall revenues; for example, a decline in our
reimbursement rates for, and therefore our average selling price of, Horizon, could result in a decline in our overall
blended average selling price. If we are not able to increase adoption of and grow revenues for our products or services,
our business and results of operations may be adversely affected.
We began offering our Vistara single-gene mutations screening test in May 2017; our Signatera cancer
recurrence monitoring offering for research use only in August 2017; our twin pregnancies screening capability for
Panorama in October 2017; and, on a limited basis, both our Signatera CLIA test and Prospera transplant rejection test in
2019. Our success with these offerings is subject to many of the risks affecting our business generally, as well as the
inherent difficulty associated with launching a new offering, including risks inherent in launching multiple new offerings
simultaneously. Our Signatera and Prospera offerings, while based upon our core molecular diagnostic technology, are
in fields that are new to us; and Vistara is subject to the risks inherent in commercializing a product with a laboratory
partner. We have had to review and, in some cases, revise our processes, procedures and agreements with our business
partners to address unforeseen operational issues and other contingencies, and will likely continue to do so as these areas
of our business grow. We cannot assure you that our Vistara, Signatera or Prospera offerings will be successful.
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If our primary CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests and our
business will be harmed.
We do not currently have redundant commercial laboratory facilities, other than third-party laboratories that we
employ to perform a significant portion of our Horizon carrier screen testing and our Vistara single-gene mutations
testing. While we are in the process of scaling up our laboratory facility in Austin, Texas to support continued growth in
our Panorama and Horizon tests, we currently have no backup or redundant facility to perform our main product and
source of revenue, Panorama, which we perform at our primary San Carlos, California laboratory facility. Our Signatera
and Prospera tests are currently also performed at this facility, and we expect that our efforts in oncology and transplant
rejection will represent significant areas of focus for us, both operationally and financially, in the near term. Our San
Carlos facility is situated near active earthquake fault lines. Our facility may be harmed or rendered inoperable, or
samples could be damaged or destroyed, by natural or manmade disasters, including earthquakes, flooding, power
outages and contamination, which may render it difficult or impossible for us to perform our tests for some period of
time. The inability to perform our tests or the backlog of tests that could develop if our San Carlos facility is inoperable
for even a short period of time may result in the loss of customers or harm our reputation.
We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments
and materials and may not be able to find replacements or immediately transition to alternative suppliers.
We have sourced and will continue to source components of our technology, including sequencers, reagents,
tubes and other laboratory materials, from third parties. In particular, our sequencers, many of our reagents, including for
Panorama and Signatera as described below, as well as Horizon, and our blood collection tubes, are sole sourced.
For example, our molecular diagnostics tests are currently only validated to perform on Illumina’s sequencing
platform; in addition, Illumina is currently the sole supplier of our sequencers and related reagents for Panorama,
Horizon, Signatera and Prospera, along with certain hardware and software, pursuant to a supply agreement that expires
in June 2026. Without sequencers and the related reagents, we would be unable to run our tests and commercialize our
products. In addition, all of the licensees under our cloud-based distribution model do not have alternatives other than to
use Illumina sequencers and reagents to run the tests that they develop based on our technology. In addition, Illumina
and Sequenom, which was acquired by LabCorp, have entered into a patent pooling agreement pursuant to which both
parties have pooled their intellectual property directed to NIPT. We understand from public filings that under the patent
pooling agreement, Illumina has the exclusive worldwide rights to, among other things, license third-party laboratories
to develop and sell NIPTs utilizing the pooled intellectual property and to enforce the pooled intellectual property
against suspected infringers. Under our supply agreement with Illumina, we do not have an express license to the pooled
intellectual property for running our own tests or to grant rights under the pooled intellectual property to the licensees
under our cloud-based distribution model. We are aware that Illumina has required our licensees, in order to secure a
supply agreement for the sequencers and reagents necessary to run NIPT under our cloud-based distribution model, to
pay an additional fee for a license under the pooled intellectual property in jurisdictions in which Illumina believes
certain of the pooled intellectual property is enforceable. This additional fee has dissuaded and could continue to
dissuade potential or current licensees from licensing from us or launching a test based on our technology. In addition,
we are involved in patent infringement litigation against Illumina, as further described in “Note 8—Commitments and
Contingencies—Legal Proceedings” in the Notes to Consolidated Financial Statements, as a part of which Illumina has
alleged that our performance of part of our Panorama test infringes one of the patents in the patent pool. While we
believe that our commercialization of Panorama in the United States does not infringe any valid patents included in the
pooled intellectual property, we cannot be certain as to the outcome of this lawsuit, including based on further claims
that could be brought during the course of the litigation, and the costs and distraction to management of defending
against this lawsuit could be significant. In addition, Illumina directly competes with us in the NIPT market through its
subsidiary, Verinata. We understand Illumina supplies the same or similar sequencers and consumables to Verinata.
Because of Illumina’s ownership of Verinata, we face increased risk and uncertainty regarding continuity of a successful
working relationship with Illumina under our supply agreement, as well as in our ability to compete with Verinata in the
marketplace in view of economic advantages enjoyed by Verinata with respect to the cost of sequencers and related
consumables. Our failure to maintain a continued supply of the sequencers and reagents, along with the right to use
certain hardware and software, would adversely impact our business, financial condition, and results of operations. In
particular, while we are seeking to validate our tests on additional sequencing platforms, such as under our license
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agreement with BGI Genomics Co., Ltd., or BGI Genomics, we have not, to date, validated any alternative sequencing
platform on which our testing could be run in a commercially viable manner. These efforts will require significant
resources, expenditures and time and attention of management, and there is no guarantee that we will be successful in
implementing any such sequencing platforms in a commercially sustainable way. We also cannot guarantee that we will
appropriately prioritize or select alternative sequencing platforms on which to focus our efforts, in particular given our
limited product and research and development resources and various business initiatives, which could result in increased
costs and delayed timelines or otherwise impact our business and results of operations.
In addition, our Panorama test is currently only validated to be performed using Streck, Inc., or Streck’s, blood
collection tubes, and Streck is the sole supplier of the blood collection tubes included in our Panorama test under a
supply arrangement with Streck under which we are required to exclusively use Streck tubes. Similarly, all of the
licensees under our cloud-based distribution model also have no current alternative but to use these blood collection
tubes to run the tests that they develop based on our technology. We also only use Streck tubes for the primary analysis
of Signatera results, and for our Prospera test. Furthermore, the blood collection tubes supplied by Streck are intended
for research use only and are labeled as RUO. Our sequencers, sourced from Illumina, as well as certain other reagents
we use for Panorama and our other tests, are also labeled as RUO. As discussed further in the risk factor entitled
“Reimbursement and Regulatory Risks Related to Our Business—Changes in the way the FDA regulates the reagents,
other consumables, and testing equipment we use when developing, validating, and performing our tests could result in
delay or additional expense in bringing our tests to market or performing such tests for our customers,” the FDA may
determine that a product labeled RUO is, nonetheless, intended to be used diagnostically, and could take enforcement
action against the supplier of the product. If this were to occur with respect to Streck, Illumina or any of our other
suppliers of RUO products, we could be required to obtain one or more alternative sources of these products, and we
may not be able to do so on commercially reasonable terms or at all. In addition, Streck’s blood collection tubes have not
been registered as a medical device in all countries in which we market our Panorama test. As discussed in the risk factor
entitled “Reimbursement and Regulatory Risks Related to Our Business—Failure to obtain necessary regulatory
approvals may adversely affect our ability to expand our operations internationally, including our ability to continue
commercializing our cloud-based distribution model,” the regulatory authorities in some of these countries may
determine that such registration is required, which could impact our ability to offer Panorama in such countries.
Furthermore, because our licensees under our cloud-based distribution model also exclusively use such sole-sourced
components to run the tests they develop based on our technology, and our laboratory distribution partners must use
certain of such sole-sourced components in order to utilize our tests, any enforcement action against the supplier by the
FDA or any other regulatory authority in the jurisdictions in which our licensees and laboratory distribution partners are
located could have an adverse impact on our business.
Because we rely on third-party manufacturers, we do not control the manufacture of these components,
including whether such components will meet our quality control requirements, nor the ability of our suppliers to comply
with applicable legal and regulatory requirements. In many cases, our suppliers are not contractually required to supply
these components to the quality or performance standards that we require. If the supply of components we receive does
not meet our quality control or performance standards, we may not be able to use the components, or if we use them not
knowing that they are of inadequate quality, which occasionally occurs with respect to certain reagents, our tests may not
work properly or at all, or may provide erroneous results, and we may be subject to significant delays caused by
interruption in production or manufacturing or to lost revenue from such interruption or from spoiled tests. In addition,
any natural or other disaster, acts of war or terrorism, shipping embargoes, labor unrest or political instability or similar
events at our third-party manufacturers’ facilities that cause a loss of manufacturing capacity would heighten the risks
that we face.
In the event of any adverse developments with our sole suppliers, or if any of our sole suppliers modifies any of
the components they supply to us, our ability to supply our products may be interrupted, and obtaining substitute
components could be difficult or require us to re-design or re-validate our products. In addition, if we obtain FDA
clearance, approval or authorization for any of our tests as an in vitro diagnostic, or IVD, such issues with suppliers or
the components that we source from suppliers could affect our commercialization efforts for such an IVD, as further
described in the risk factor entitled “Reimbursement and Regulatory Risks Related to Our Business—If the FDA were to
begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain
premarket clearance or approval and incur costs associated with complying with post-market controls.” Our failure to
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maintain a continued supply of components, or a supply that meets our quality control requirements, or changes to or
termination of our agreements or inability to renew our agreements with these parties or enter into new agreements with
other suppliers, particularly in the case of sole suppliers such as Streck and Illumina, could result in the loss of access to
important components of our tests and impact our test performance or affect our ability to perform our tests in a timely
manner or at all, which could impair, delay or suspend our commercialization activities. In the event that we transition to
a new supplier from any of our sole suppliers, doing so could be time-consuming and expensive, may result in
interruptions in our ability to supply our products to the market, could affect the performance of our tests or could
require that we re-validate Panorama and our other tests using replacement equipment and supplies, which could delay
the performance of our tests and result in increased costs. Any of these occurrences could have a material adverse effect
on our business, financial condition and results of operations.
We rely on commercial courier delivery services to transport samples to our facilities in a timely and cost-efficient
manner and if these delivery services are disrupted, our business will be harmed.
Our core business depends on our ability to quickly and reliably deliver test results to our customers. We
typically receive blood samples for analysis at our San Carlos, California facility within days of collection from the
patient. Disruptions in delivery service, whether due to error by the courier service, labor disruptions, bad weather,
natural disaster, terrorist acts or threats or for other reasons, could adversely affect specimen integrity, our ability to
process or store samples in a timely manner and to 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.
Security breaches, loss of data and other disruptions, including with respect to cybersecurity, 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 reputation.
In the ordinary course of our business, we collect and store sensitive data, including legally-protected personal
information, such as test results and other patient health information, credit card and other financial information,
insurance information, and personally identifiable information. We also store sensitive intellectual property and other
proprietary business information, including that of our customers, payers and collaboration partners. We are highly
dependent on information technology networks and systems, including a combination of on-site systems, managed data
center systems and cloud-based data center systems, and the Internet, to securely process, transmit, and store a wide
variety of business-critical information, including research and development information, commercial information and
business and financial information. We also communicate sensitive data, including patient data, telephonically, through
our website, through facsimile, through integrations with third party electronic medical records systems, and through
relationships with third party vendors and their subcontractors, both in the United States and internationally. The laws of
some foreign countries do not protect data privacy to the same extent as the laws of the United States.
The secure processing, storage, maintenance and transmission of this critical information are vital to our
operations and business strategy. Although we take measures to protect sensitive information from unauthorized access,
use or disclosure, our information technology and infrastructure, and that of our technology and other third party service
providers and their subcontractors, may nevertheless be vulnerable to cyber-attacks by hackers or viruses or breaches
due to employee error, malfeasance or other disruptions. Any such breach or interruption could compromise our data
security, and the information we store could be inaccessible by us or could be accessed by unauthorized parties, publicly
disclosed, lost or stolen. Any such interruption in access, improper access, disclosure, modification, or other loss of
information could result in legal claims or proceedings, liability or penalties under laws and regulations that protect the
privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996, or HIPAA,
European data privacy regulations, such as the General Data Protection Regulation, or GDPR, state privacy regulations
such as the California Consumer Privacy Act. We may be required to comply with state breach notification laws,
become subject to mandatory corrective action, or be required to verify the correctness of database contents.
Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests,
provide test results, bill payers or patients, process claims and appeals, provide customer assistance services, conduct
research and development activities, develop and commercialize tests, collect, process and prepare company financial
information, provide information about our tests, and manage the administrative aspects of our business, any of which
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could damage our reputation and adversely affect our business. In addition, these breaches and other inappropriate
access can be difficult to detect, and any delay in identifying them may compound these adverse consequences. Any
such breach could also result in the compromise of our trade secrets and other proprietary information, which could
adversely affect our competitive position.
For example, in May 2019, we were notified of a data security incident that compromised the computer systems
of Retrieval-Masters Creditors Bureau, Inc. d/b/a American Medical Collection Agency, or AMCA, one of our third
party vendors, and affected a limited number of our patients whose data was stored in AMCA’s systems. While the
accessed data did not include Social Security numbers, the credit card information of a small number of the patients was
compromised. We notified the affected individuals as required by HIPAA.
Our cloud-based distribution model adds additional data privacy risk, as certain personal health and other
information may be sent to and stored in the cloud by our laboratory licensees, many of which are located outside of the
United States. We contractually prohibit our licensees from sending personally-identifiable information to our cloud
servers, and the vendor that hosts our software in the cloud is contractually required to comply with data privacy laws,
such as HIPAA and GDPR. However, we cannot be certain that these third parties will comply with the terms of our
agreements, nor that they will not experience security breaches or other disruptions.
The marketing, sale, and use of Panorama and our other products could result in substantial damages arising from
product liability or professional liability claims that exceed our resources.
The marketing, sale and use of Panorama and our other products could lead to product liability claims against
us if someone were to allege that our test failed to perform as it was designed or as claimed in our promotional materials,
was performed pursuant to incorrect or inadequate laboratory procedures, if we delivered incorrect or incomplete test
results, or if someone were to misinterpret test results. In addition, we may be subject to liability for errors in, a
misunderstanding of, or inappropriate reliance upon, the information we provide, or for failure to provide such
information, in connection with our marketing and promotional activities or as part of the results generated by Panorama
and our other products. For example, Panorama could provide a low-risk result which a patient or physician may rely
upon to make a conclusion about the health of the fetus, which may, in fact, have the condition for which we delivered a
low-risk result because the Panorama result was a so-called false negative. Even though Panorama and our other tests are
highly accurate, they are not 100% accurate and we may report false negative results. If the resulting baby with the
condition is born, the family may file a lawsuit against us claiming product or professional liability, as has happened in
the past and may happen in the future. 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 product and professional liability
insurance, our insurance may not fully protect us from the financial impact of defending against product liability or
professional liability claims or any judgments, fines or settlement costs arising out of any such claims. Any product
liability or professional liability claim brought against us, with or without merit, could increase our insurance rates,
cause our insurance coverage to be terminated or prevent us from securing insurance coverage in the future.
Additionally, any product liability or professional liability lawsuit could harm our reputation, result in a cessation of our
services or cause our partners to terminate our agreements with them, any of which could adversely impact our results of
operations.
If we are unable to successfully scale our operations, our business could suffer.
Our overall test volumes grew from approximately 515,200 to 668,600 and further to 804,300 tests processed
during the years ended December 31, 2017, 2018 and 2019, respectively, and since 2009 we have launched 12 product
offerings, four of them in 2017 alone. In addition, we regularly evaluate and refine our testing process, often
significantly updating our workflows, as with Panorama in 2017 and Horizon in 2018. As our test volumes and product
offerings continue to grow, we will need to continue to ramp up our testing capacity and implement increases in scale.
We will need additional or new equipment, laboratory space and qualified laboratory personnel, and will need to
increase office and laboratory space, expand our customer service capabilities, implement billing and systems process
improvements, enhance our controls and procedures and expand our internal quality assurance program and technology
platform. The value of Panorama, Horizon and our other products depends on our ability to perform the tests on a timely
basis and at an exceptionally high standard of quality, and on maintaining our reputation for such timeliness and quality.
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Failure to implement necessary procedures, transition to new facilities, equipment or processes or to hire the necessary
personnel in a timely and effective manner could result in higher processing costs or an inability to meet market demand,
or could otherwise affect our operating results, as we have experienced in the past. We have recently transitioned a
component of our insurance billing operations to a third party service provider, and may face similar challenges in
connection with this transition.
In addition, our efforts to scale our operations may be unable to keep pace with an increase in the frequency of
our launches of new or enhanced products and services. We have launched five new products in the past three years,
three of which are in markets or industries new to us. As we continue to launch additional offerings and product
enhancements, we will need to manage our resources among various initiatives, and such competing priorities could lead
to delays in one or more of our business initiatives. Conversely, to the extent that we scale our operations, infrastructure
and other resources but do not ultimately meet our anticipated timelines in our product development efforts, we will
experience higher costs and expenses than necessary until our project timelines and operational resources become
aligned. We may also, intentionally or unintentionally, allocate resources to new products or initiatives in a manner
disproportionate to the amount of revenue that such initiatives generate compared to our existing or core offerings. We
cannot assure you that our efforts to scale our commercial operations will not negatively affect the quality of our test
process or results, or that we will be successful in managing the growing complexity of our business operations.
To execute our growth plan, we must attract and retain highly qualified personnel. Competition for these
personnel is intense, especially for sales, scientific, medical, laboratory, research and development and other technical
personnel, and especially in the San Francisco Bay Area where our headquarters and main laboratory facilities are
located, and the turnover rate of such personnel can be high. We have from time to time experienced, and we expect to
continue to experience, difficulty in hiring and retaining employees with appropriate qualifications. Many of the
companies with which we compete for highly qualified personnel have greater resources than we have. If we hire
employees from competitors or other companies, their former employers may attempt to assert that these employees or
we have breached their legal obligations to their former employers, which occurs from time to time. In addition, job
candidates and existing employees in the San Francisco Bay Area often consider the value of the equity awards they
receive in connection with their employment. To the extent that our current or potential employees perceive the value of
our equity awards to be low, our ability to recruit, retain and motivate highly skilled employees may be adversely
affected, which could then have an adverse effect on our business and future growth prospects. Furthermore, to the
extent that we are unable to retain our employees and they leave our company to join one of our competitors, we cannot
assure you that any invention, non-disclosure or non-compete agreements we have in place will provide meaningful
protection against a departing employee’s unauthorized use or disclosure of our confidential information, as further
discussed in “—Risks Relating to our Intellectual Property—If we are not able to adequately protect our trade secrets
and other proprietary information, the value of our technology and products could be significantly diminished.”
In addition, our growth may place a significant strain on our operating and financial systems and our
management, sales, marketing and administrative resources. As a result of our growth, our operating costs may escalate
faster than we anticipate, we may face difficulties in obtaining additional office or laboratory space, and some of our
internal systems may need to be enhanced or replaced. If we cannot effectively manage our expanding operations and
our costs, we may not be able to grow successfully or we may grow at a slower pace, and our business could be
adversely affected.
If our sales and distribution partnerships are not successful and we are not able to offset the resulting impact through
our direct sales efforts or through agreements with new partners, our commercialization activities may be impaired
and our financial results could be adversely affected.
While we have increased the focus of our commercial efforts on our U.S. direct sales force, we continue to rely
on relationships with laboratory and other partners to sell Panorama and our other products, both in the United States and
internationally. For example, we have entered into an agreement with BGI Genomics pursuant to which, among others,
we will commercialize Signatera in China and develop reproductive health tests on BGI Genomics’s sequencing
platform; we have also recently entered into an agreement with a transplant diagnostics company to co-market our
Prospera test in conjunction with our direct sales force. Distributing Panorama, Signatera and our other products through
partners reduces our control over our revenues, our market penetration and our gross margin on sales by the partner if we
could have otherwise made that sale through our direct sales force. The financial condition of these partners could
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weaken, or they could terminate their relationship with us and/or stop selling our products, as has happened in the past;
reduce their marketing efforts in respect of our products; develop and commercialize or otherwise sell competing
products in addition to or in lieu of our tests, as has also occurred; merge with or be acquired by a competitor of ours or a
company that chooses to de-prioritize the efforts to sell our products; or otherwise breach their agreements with us. For
example, as further described in “Note 3—Revenue Recognition—Licensing and Other Revenues—Qiagen,” we had
entered into a license, distribution and development agreement with Qiagen pursuant to which, among others, Qiagen
would distribute an NIPT based on our Panorama test on a sequencer to be developed by us and Qiagen; however,
Qiagen has announced that it has discontinued the development of its Next Generation Sequencing Platform and has now
partnered with Illumina to develop next-generation sequencing based tests. Furthermore, our laboratory partners may
misappropriate our trade secrets or use our proprietary information in such a way as to expose us to litigation and
potential liability; and our compliance risk may increase to the extent that we are responsible for our partners’ sales and
marketing activities. Disagreements or disputes with our laboratory partners, including disagreements over customers,
proprietary rights or our or their compliance with contractual obligations, might cause delays or impair the
commercialization of Panorama, Signatera or our other tests, lead to additional responsibilities for us with respect to new
tests, or result in litigation or arbitration, any of which would divert management attention and resources and be
time-consuming and expensive. As is typical for companies in our industry, we are continually evaluating and pursuing
various strategic or commercial partnerships, relationships, or collaborations, some of which may involve the sale and
issuance of our common stock, which could result in additional dilution of the percentage ownership of our stockholders
and could cause the price of our common stock to decline.
If our partnerships are not successful, our ability to increase sales of Panorama and our other products and to
successfully execute our strategy could be compromised.
Our financial condition and results of operations may be adversely affected by international regulatory and business
risks.
As we expand our operations, including by offering our tests in other countries, we are increasingly subject to
varied and complex foreign and international laws and regulations due to operating, offering our products, or contracting
with employees, contractors and other service providers in various other countries. Compliance with these laws and
regulations often involves significant costs and may require changes in our business practices that may result in reduced
revenues and adversely affect our operating results.
We are subject to the Foreign Corrupt Practices Act of 1977, as amended, or 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. Our reliance on independent
laboratories to sell Panorama and other products internationally demands a high degree of vigilance in maintaining our
policy against participation in corrupt activity, because these distributors could be deemed to be our agents and we could
be held responsible for their actions. Other U.S. companies in the medical device and pharmaceutical field have faced
criminal penalties under the FCPA for allowing their agents to deviate from appropriate practices in doing business with
foreign government officials. 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. 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 we could be subject to severe penalties, including criminal and
civil penalties, disgorgement, and other remedial measures, any of which could result in a material adverse effect on our
business, prospects, financial condition, or results of operations.
In addition, our international activities are subject to U.S. economic and trade sanctions, which restrict or
otherwise limit our ability to do business in certain designated countries. Other limitations, such as restrictions on the
import into the United States or the export to other countries of tissue or genetic data necessary for us to perform our
tests, or restrictions on importation and circulation of blood collection tubes or other equipment or supplies by countries
outside of the United States, may limit our ability to offer our tests internationally. We may also face competition from
companies located in the countries in which we or our partners or licensees offer our tests, and in which we may be at a
competitive disadvantage because the country may favor a local provider or for other reasons.
By operating internationally, we may experience longer accounts receivable payment cycles and difficulties in
collecting accounts receivable; realize lower margins due to lower pricing in many countries; incur potentially adverse
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tax consequences, including the complexities of foreign value added tax systems, tax inefficiencies related to our
corporate structure and restrictions on the repatriation of earnings; experience financial accounting and reporting burdens
and complexities; experience difficulties in staffing and managing foreign operations, including under labor and
employment laws and regulations that are new or unfamiliar to us; be subject to trade barriers such as tariffs, quotas,
preferential bidding or import or export licensing requirements; be exposed to political, social and economic instability
abroad, including terrorist attacks and security concerns; be exposed to fluctuations in currency exchange rates; and
experience reduced or varied protection for intellectual property rights and practical difficulties in enforcing intellectual
property and other rights, including with respect to assignment of inventions to us by our consultants in foreign
jurisdictions.
Outside of the United States we enlist local and regional laboratories, contract employees and other contracted
service providers to assist with various aspects of our business operations, including blood draws, engineering, sales,
marketing, billing and customer support. Subject to regulatory clearance where required, we also contract with
international licensees to run the molecular portion of our tests in their own labs and then access our algorithm for
analysis of the resulting data through our cloud-based Constellation platform. Locating, qualifying and engaging
additional distribution partners and local laboratories with local industry experience and knowledge is necessary to
effectively market and sell our tests outside of the United States. We may not be successful in finding, attracting and
retaining such distribution partners or laboratories, or we may not be able to enter into such arrangements on favorable
terms. Sales practices and other activities utilized by our distribution partners, contract employees and other service
providers, some of which may be locally acceptable, may not comply with relevant standards required under United
States laws that apply to our operations overseas, including through third parties, which could create additional
compliance risk. Our training and compliance program and our other internal control policies and procedures, and our
contractual terms with these third parties, may not always protect us from acts committed by our employees, contractors,
partners or agents abroad. Non-compliance by us or our employees, contractors, partners or agents, whether maliciously
or in error, of any applicable laws or regulations could result in fines or penalties, or adversely affect our ability to
operate and grow our business. Even if we are able to effectively manage our international operations, if our distribution
partners and local and regional laboratory licensees are unable to effectively manage their businesses, our business and
results of operations could be adversely affected. Furthermore, the legal landscape governing advertising, promotional
and other marketing activities can vary widely from jurisdiction to jurisdiction, and is often more complex, less clear or
less developed than in the United States. If our marketing activities are found to be in violation of local laws, regulations
or practices, we may be subject to fines and other penalties, and may be required to cease marketing or
commercialization activities in such jurisdiction. If our sales and marketing efforts are not successful outside of the
United States, we may not achieve market acceptance for our tests outside of the United States, which would harm our
business.
Operating internationally requires significant management attention and financial resources. We cannot be
certain that the investment and additional resources required to increase international revenues or expand our
international presence will produce desired levels of revenues or profitability.
If we lose the services of our founder and Executive Chairman or other members of our senior management team, we
may not be able to execute our business strategy.
Our success depends in large part upon the continued service of our senior management team. In particular, our
founder and Executive Chairman, Matthew Rabinowitz, as well as Steve Chapman, our Chief Executive Officer, are
critical to our vision, strategic direction, culture, products and technology. Although Dr. Rabinowitz spends significant
time with us and is active in our management, he is no longer our Chief Executive Officer. In addition, we do not
maintain key-man insurance for Dr. Rabinowitz, Mr. Chapman or any other member of our senior management team.
The loss of our founder and Executive Chairman, our Chief Executive Officer or one or more other members of our
senior management team could have an adverse effect on our business.
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We may engage in acquisitions, dispositions or other strategic transactions that could disrupt our business, cause
dilution to our stockholders or reduce our financial resources.
From time to time, we may enter into transactions to acquire or dispose of businesses, products or technologies
or to engage in other strategic transactions. Because we have not made any such acquisitions or dispositions to date, our
ability to do so successfully is unproven. Even if we identify suitable transactions, we may not be able to complete such
transactions on favorable terms or at all. Any acquisitions or other strategic transactions we consummate may not
strengthen our competitive position, and these transactions may be viewed negatively by customers or investors. We
may decide to incur debt in connection with an acquisition or issue shares of our common stock or other equity securities
to the stockholders of the acquired company, which would cause dilution to our existing stockholders. We could incur
losses resulting from such strategic transactions, including undiscovered liabilities of an acquired business that are not
covered by any indemnification we may obtain from the seller. In addition, we may not be able to successfully integrate
any acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive
manner. Any dispositions may also cause us to lose revenue and may not strengthen our financial position. Strategic
transactions may also divert management attention from day-to-day responsibilities, increase our expenses, result in
accounting charges, and reduce our cash available for operations and other uses. We cannot predict the number, timing
or size of future strategic transactions or the effect that any such transactions might have on our operating results.
We may need to raise additional funds through public or private equity or debt financings, corporate
collaborations or licensing arrangements to continue to fund or expand our operations.
Our actual liquidity and capital funding requirements will depend on numerous factors, including:
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our ability to achieve broader commercial success with Panorama, Horizon and our other products;
the costs and success of our research, development, and commercialization efforts for potential new
products;
our ability to obtain more extensive coverage and reimbursement for our tests, including in the average-risk
patient population and for microdeletions screening in NIPT, as well as in additional indications in
oncology as we continue to expand our offerings in that field;
our ability to generate sufficient revenues from our cloud-based distribution model;
our ability to collect on our accounts receivable;
our need to finance capital expenditures and further expand our clinical laboratory operations;
our ability to manage our operating costs; and
the timing and results of any regulatory authorizations that we are required to obtain for our tests.
Additional capital, if needed, may not be available on satisfactory terms or at all. Furthermore, any additional
capital raised through the sale of equity or equity-linked securities, or grant of equity or equity-linked securities in
connection with any debt financing, will dilute stockholders’ ownership interests in us and may have an adverse effect
on the price of our common stock. In addition, the terms of any financing may adversely affect stockholders’ holdings or
rights. Debt financing, if available, may include restrictive covenants, and may impose other constraints on us and our
operations, as is the case under our 2017 Term Loan, as further described in the risk factor entitled “—Our outstanding
debt may impair our financial and operating flexibility.” To the extent that we raise capital through collaborations and
licensing arrangements, it may be necessary to relinquish some rights to our technologies or grant licenses on terms that
may not be favorable to us.
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If we are not able to obtain adequate funding when needed, we may have to delay development programs or
sales and marketing initiatives. In addition, we may have to work with a partner on one or more of our tests or programs,
which could lower the economic value of those programs to our company.
Our outstanding debt may impair our financial and operating flexibility.
As of December 31, 2019, we had approximately $123.8 million of debt outstanding with accrued interest,
comprising $73.7 million outstanding under our 2017 Term Loan and $50.1 million outstanding under our Credit Line
with UBS, including unpaid interest. Except for operating leases, we do not have any off-balance sheet financing
arrangements in place or available. Our 2017 Term Loan contains various restrictive covenants and is secured by
substantially all of our assets, including our intellectual property. These restrictions could limit our ability to use
operating cash flow in other areas of our business because we must use a portion of these funds to make principal and
interest payments on our debt; conversely, our ability to make principal and interest payments on our indebtedness will
depend on our ability to generate cash. If we default under the 2017 Term Loan or the Credit Line and if the default is
not cured or waived, the lenders could terminate their commitments to lend to us and cause any amounts outstanding to
be payable immediately. Under certain circumstances, they could also exercise their rights under the security agreements
entered into in connection with the loans. Such a default could also result in cross defaults under other debt instruments.
Moreover, any such default would limit our ability to obtain additional financing, which may have an adverse effect on
our cash flow and liquidity. Any refinancing of our existing indebtedness or the incurrence of additional indebtedness
could have similar or more restrictive terms.
We may incur additional indebtedness in the future. If we incur additional debt, a greater portion of our cash
flows may be needed to satisfy our debt service obligations, and if we do not generate sufficient cash to meet our debt
service requirements, we may need to seek additional financing. In that case, it may be more difficult, or we may be
unable, to obtain financing on terms that are acceptable to us. As a result, we would be more vulnerable to general
adverse economic, industry and capital markets conditions in addition to the risks associated with indebtedness described
above.
Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests.
DNA testing, like that conducted using Panorama, Horizon, Signatera, and our other products, has raised
ethical, legal and social issues regarding privacy and the appropriate uses of the resulting information. Governmental
authorities could, for social or other purposes, limit or regulate the use of genomic information or genomic testing or
prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure. Patients
may also refuse to use genetic tests even if permissible, for similar reasons; they may also refuse genetic testing due to
concerns regarding eligibility for life or other insurance. Ethical and social concerns may also influence U.S. and foreign
patent offices and courts with regard to patent protection for technology relevant to our business. These and other
ethical, legal and social concerns may limit market acceptance of our tests or reduce the potential markets for services
and products enabled by our technology platform, either of which could harm our business.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
We have a significant amount of net operating loss, or NOL, carryforwards that can be used to offset potential
future taxable income and related income taxes. As of December 31, 2019, we had federal and state NOL carryforwards
of approximately $514.0 million and $271.6 million, respectively, which, if not utilized, begin to expire in 2027 and
2028, respectively. We also had federal research and development credit carryforwards of approximately $15.7 million,
which begin to expire in 2027, and state research and development credit carryforwards of approximately $13.0 million,
which can be carried forward indefinitely. Under Section 382 of the Internal Revenue Code of 1986, as amended, if a
corporation undergoes an “ownership change” (generally defined as a greater than 50% change, by value, in equity
ownership over any three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other
pre-change tax attributes to offset its post-change income or taxes may be limited. We may have experienced an
“ownership change” upon our initial public offering; we may also experience ownership changes in the future as a result
of subsequent shifts in our stock ownership, some of which may not be within our control. Our ability to use these
carryforwards could be limited if we experience an “ownership change.”
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Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate,
and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar
rates.
Total addressable market opportunity estimates and growth forecasts are subject to significant uncertainty and
are based on assumptions and estimates that may not prove to be accurate. Our publicly announced estimates and
forecasts relating to the size and expected growth of our market may prove to be inaccurate. Even if the market in which
we compete meets our size estimates and forecasted growth, our business could fail to grow at similar rates.
Reimbursement and Regulatory Risks Related to Our Business
If we are unable to expand, maintain or obtain third-party payer coverage and reimbursement for Panorama,
Horizon and our other tests, or if we are required to refund any reimbursements already received, our revenues and
results of operations would be adversely affected.
Our business depends on our ability to obtain and maintain adequate reimbursement coverage from third-party
payers and patients. Third-party reimbursement for our testing represents a significant portion of our revenues, and we
expect third-party payers such as insurance companies and government healthcare programs to continue to be our most
significant source of payments. In particular, we believe that the following will be necessary for us to continue to
achieve commercial success: expanding insurance coverage from the high-risk to the average-risk pregnancy population,
which represents roughly 80% of the United States pregnancy market, and for microdeletions screening, and obtaining
positive coverage determinations and favorable reimbursement rates from commercial third-party payers, the Centers for
Medicare & Medicaid, or CMS, and state reimbursement programs for our tests. We do not expect to receive
reimbursement for a significant number of Panorama tests for average-risk patients and for microdeletions that we
performed in the quarter ended December 31, 2019. In addition, while our Signatera test received a Medicare positive
draft local coverage determination for certain forms of colorectal cancer in August 2019, that local coverage decision has
not been finalized and it remains unclear whether and to what extent Signatera will be reimbursed for this indication. We
are also working towards a full-scale commercial launch of our Prospera transplant rejection test, and while we are
basing our reimbursement estimates on the rate at which a similar test currently on the market is reimbursed, we cannot
guarantee that our test will be reimbursed at the same or a similar rate. If we are unable to obtain or maintain adequate
reimbursement coverage from, or achieve in-network status with, third-party payers for our existing or future tests, our
ability to generate revenues will be limited. For example, physicians may be reluctant to order our tests due to the
potential of a substantial cost to the patient if reimbursement coverage is unavailable or insufficient.
In making coverage determinations, third-party payers often rely on practice guidelines issued by professional
societies. The American College of Medical Genetics, or ACMG, has issued updated guidelines recommending
informing pregnant women that NIPT is the most sensitive screening option for Patau, Edwards and Down syndromes,
as well as of the availability of the expanded use of NIPT to screen for clinically relevant copy number variants, or
CNVs, in the context of counseling that includes the risks/benefits and limitations of screening for CNVs. A CNV is a
genetic mutation in which a segment of the genome has been deleted or duplicated, including microdeletions in which a
small segment of a chromosome is deleted. The International Society for Prenatal Diagnosis, or ISPD, has issued
guidelines that are supportive of performing NIPT in average-risk pregnancies, as well as high-risk pregnancies.
However, the Society for Maternal Fetal Medicine, or SMFM, has issued guidelines for NIPT stating that, while all
pregnant women should be informed of the option to receive NIPT, conventional screening methods, such as traditional
serum screening, rather than NIPT, remain the most appropriate choice for first-line screening for average-risk
pregnancies. While we expect the ACMG and SMFM guidelines to result in an increase in the number of average-risk
women who are informed of NIPT and that may request it as a result, not all third-party payers reimburse for NIPT for
these average-risk patients. Currently, Aetna Inc., UnitedHealthcare Insurance Company and a number of other
third-party payers have negative coverage determinations for NIPT in average-risk patient populations, meaning that
their policy is not to reimburse for NIPT for patients in the average-risk population. The SMFM guidelines also echoed a
previous statement from SMFM that routine screening for microdeletions should not be performed. Many third-party
payers do not reimburse for microdeletions screening. While we have published data on the performance of Panorama
for the 22q11.2 deletion syndrome, we have and may continue to experience a negative impact on third-party payers’
reimbursement for Panorama for microdeletions, at least until additional validation data on the sensitivity and specificity
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of our tests becomes available. If we are unable to present satisfactory additional data on the performance of Panorama
for 22q11.2 deletion syndrome, including from our SMART study, we may be unable to obtain positive coverage
determinations for our test. If third-party payers do not reimburse for NIPT for average-risk pregnancies or
microdeletions in the future, our future revenues and results of operations would be adversely affected, particularly to the
extent that we continue to perform large volumes of tests for which third-party payors do not reimburse.
In addition, a CPT code for microdeletions took effect in January 2017. We have experienced low average
reimbursement rates for microdeletions under this code, and we expect that this code will continue to cause our
microdeletions reimbursement to remain low, at least in the near term, due to third-party payers declining to reimburse
and as a result of reduced reimbursement, under the code, which has had, and we expect to continue to have, an adverse
effect on our revenues. In addition, a new CPT code for expanded carrier screening tests took effect in January 2019.
The new code has caused and may continue to cause reimbursement rates for our broader Horizon carrier screening
panel to decrease because those tests may be reimbursed as a combined single panel instead of as multiple individual
tests.
The reimbursement environment, particularly for molecular diagnostics, is continually changing and our efforts
to broaden reimbursement for our tests with third-party payers may not be successful. Third-party payers from whom we
have received reimbursement may withdraw coverage or decrease the amount of reimbursement coverage for our tests at
any time and for any reason. In some cases, our tests or their uses within certain populations, such as for microdeletions,
are considered experimental by third-party payers and, as a result, some payers have decided not to reimburse for such
tests. In addition, some third-party payers bundle payment for multiple tests or tests that screen for multiple conditions,
such as our Horizon test or our Panorama test and the separate Panorama screen for microdeletions, into a single
payment rate, thereby limiting our reimbursement in those situations. Payers may also dispute our billing or coding.
Based on any of the foregoing, third-party payers may also decide to deny payment or recoup payment for testing that
they contend to have been not medically necessary, against their coverage determinations, or for which they have
otherwise overpaid, and we may be required to refund reimbursements already received. We deal with requests for
recoupment from third-party payers from time to time in the ordinary course of our business, and it is likely that we will
continue to do so in the future. See “Note 8—Commitments and Contingencies—Third-Party Payer Reimbursement
Audits” in the Notes to Consolidated Financial Statements. If a third-party payer denies payment for testing,
reimbursement revenue for our testing could decline. If a third-party payer successfully proves that payment for prior
testing was in breach of contract or otherwise contrary to law, they may recoup payment, which amounts could be
significant and would impact our results of operations, and it may decrease reimbursement going forward. We may also
decide to negotiate and settle with a third-party payer in order to resolve an allegation of overpayment. Any of these
outcomes might require us to restate our financials from a prior period, which would likely cause our stock price to
decline. For example, in 2018 we reached a settlement with certain government payers regarding past reimbursement
submissions; although the settlement involved no admission of fault by us and no corporate integrity agreement, we
cannot guarantee that we will not be subject to similar claims, resulting in additional settlements or repayments, in the
future.
Furthermore, some of our contracts with third-party payers contain so-called most favored nation provisions,
pursuant to which we have agreed that we will not bill the third-party payer more than we bill any other third-party
payer. We must therefore monitor our billing and claims submissions to ensure that we remain in compliance with these
contractual requirements with third-party payers. If we do not successfully manage these most favored nation provisions,
we may need to forego revenues from some third-party payers or reduce the amount we bill to each third-party payor
with a most-favored nation clause in its contract that is violated, which would adversely affect our revenues. This
situation could also subject us to claims for recoupment, which could require the time and attention of our management,
require the expense of engaging outside counsel or consultants, and may be a distraction from development of our
business, adversely impacting our operations. Such recoupment demands could also ultimately result in an obligation to
repay amounts previously earned.
In addition, if a third-party payer denies coverage, it may be difficult for us to collect from the patient, and we
may not be successful in doing so. In particular, we are often unable to collect the full amount of a patient’s
responsibility where we are an out-of-network provider and the patient is left with a large balance, despite our good faith
efforts to collect. As a result, we cannot always collect the full amount due for our tests when third-party payers deny
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coverage, cover only a portion of the invoiced amount or the patient has a large deductible, which may cause payers to
raise questions regarding our billing policies and patient collection practices. We believe that our billing policies and our
patient collection practices are compliant with applicable laws. However, we have in the past received, and we may in
the future receive, inquiries from third-party payers regarding our billing policies and collection practices. While we
have addressed these inquiries as and when they have arisen, there is no guarantee that we will always be successful in
addressing such concerns in the future, which may result in a third-party payer deciding to reimburse for our tests at a
lower rate or not at all, seeking recoupment of amounts previously paid to us, or bringing legal action to seek
reimbursement of previous amounts paid. Any of such occurrences could cause reimbursement revenue for our testing,
which constitutes the large majority of our revenue, to decline. Additionally, if we were required to make a repayment,
such repayment could be significant, this would impact our results of operations, and we might be required to restate our
financials from a prior period, which would likely cause our stock price to decline.
We are aware of policies and practices of our competitors to offer patients a set cap on their out-of-pocket
responsibility, waive patient responsibility altogether, and, in some cases, to not send patients a bill at all, all of which
we believe is not in accordance with third-party payers’ policies and, in many cases, not compliant with the law. In
contrast, it is our policy not to offer such caps or waivers and to send bills to patients for services rendered. Because of
this discrepancy, our offerings may be perceived as less attractive to patients and their healthcare providers, who are
concerned about patients having a large financial responsibility for these products. As a result, we believe that our
revenues and results of operations have been adversely affected, and may continue to be so affected to the extent that our
competitors continue such practices.
Our revenues may be adversely affected if we are unable to successfully obtain reimbursement from the Medicare
program and state Medicaid programs.
Our revenues from Medicare are currently very small, given the population that Medicare covers, and the fact
that our testing generally is not received by Medicare beneficiaries. As a result, we do not expect our Medicare revenues
to change materially with regard to NIPT. However, Medicare reimbursement will impact our future revenue from our
Signatera CLIA test as well as our Prospera test, as a large proportion of oncology and transplant patients are covered by
Medicare. Furthermore, Medicare reimbursement can affect both Medicaid reimbursement, which is relevant to NIPT,
and reimbursement from commercial third-party payers. Specifically, fee-for-service Medicaid programs generally do
not reimburse at rates that exceed Medicare’s fee-for-service rates, and many commercial third-party payers set their
payment rates at a percentage of the amounts that Medicare pays for testing services. Medicare reimbursement rates are
typically based on the Clinical Laboratory Fee Schedule, or CLFS, set by CMS. Our current Medicare Part B
reimbursement was not set pursuant to a national coverage determination by CMS. Although we believe that coverage is
available under Medicare Part B even without such a determination, we currently lack the certainty afforded by a formal
national coverage determination by CMS. Thus, CMS could issue an adverse coverage determination as to Panorama
which could influence other third-party payers, including Medicaid, and could have an adverse effect on our revenues.
It is estimated that nearly half of all births in the United States are to state Medicaid program recipients. Each
state’s Medicaid program has its own coverage determinations related to our testing, and many state Medicaid programs
do not provide their recipients with coverage for our testing. Even if our testing is covered by a state Medicaid program,
we must be recognized as a Medicaid provider by the state in which the Medicaid recipient receiving the services resides
in order for us to be reimbursed by a state’s Medicaid program, including under a Medicaid managed care plan. As of
February 1, 2020, we are recognized by 47 states as a Medicaid provider. It is likely that we will not be able to be
recognized as a provider by additional Medicaid programs because some states require that a provider maintain a
physical laboratory in that state in order to be recognized; furthermore, some states have closed provider panels, which
means that the state does not intend to expand its current provider network and therefore does not intend to recognize
additional Medicaid providers. Even if we are recognized as a provider in a state, if Medicare’s CLFS rate for our
services and tests are low, the Medicaid reimbursement amounts are sometimes as low, or lower, than the Medicare
reimbursement rate. In addition, from time to time we receive requests from state Medicaid programs seeking
information or documents to determine eligibility for and the amount of Medicaid reimbursement. As a result of all of
these factors, many state Medicaid programs only reimburse our testing at a very low dollar amount, or not at all. Low or
zero-dollar Medicaid reimbursement rates for our tests could have an adverse effect on our business and revenues.
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Our revenues may be adversely impacted if third-party payers withdraw coverage or provide lower levels of
reimbursement due to changing policies, billing complexities or other factors.
We are in network, or under contract, with the significant majority of third-party payers from whom we receive
reimbursement; this means that we have agreements with most third-party payers that govern approval or payment terms.
However, these contracts do not guarantee reimbursement for all testing we perform. For example, many third-party
payers with whom we have written agreements have policies that state they will not reimburse for use of NIPTs for
average-risk pregnancies or for the screening of microdeletions, or don’t have a policy in place to reimburse for
microdeletions screening. In addition, the terms of certain of our agreements require a physician or qualified
practitioner’s signature on test requisitions or require other controls and procedures prior to conducting a test. In
particular, third-party payers have increasingly required prior authorization to be obtained prior to conducting a test, as a
condition to reimbursing for the test. This has placed a burden on our billing operations as we have to dedicate resources
to ensuring that these requirements are met and to conduct follow-up and address issues as they arise, and has also
impacted our results of operations, including our gross margins, since the fourth quarter of 2017, when these
requirements began to take effect. To the extent we or the physicians ordering our tests do not follow the prior
authorization requirements, we may be subject to claims for recoupment of reimbursement amounts previously paid to
us, or may not receive some or all of the reimbursement payments to which we would otherwise be entitled. This has
occurred in some cases and may occur more frequently in the future, which does and would have an adverse impact on
our revenues.
Where we are considered to be an out of network provider, which is the case with some third-party payers from
whom we receive reimbursement, such third-party payers could withdraw coverage and decline to reimburse for our tests
in the future, for any reason. Managing reimbursement on a case-by-case basis is time-consuming and contributes to an
increase in the number of days it takes us to collect on accounts, which also increases our risk of non-payment.
Negotiating reimbursement on a case-by-case basis also typically results in the receipt of reimbursement at a significant
discount to the list price of our tests.
Even if we are being reimbursed for our tests, third-party payers may review and adjust the rate of
reimbursement, require co-payments from patients or stop paying for our tests. Government healthcare programs and
other third-party payers continue to increase their efforts to control the cost, utilization and delivery of healthcare
services by demanding price discounts or rebates and limiting coverage of, and amounts they will pay for, molecular
diagnostic tests. These measures have resulted in reduced payment rates and decreased utilization in the clinical
laboratory industry. Because of these cost-containment measures, governmental and commercial third-party payers may
reduce, suspend, revoke or discontinue payments or coverage at any time, including payors that currently provide
reimbursement for our tests. Reduced reimbursement of our tests may harm our business, financial condition or results of
operations.
Billing for clinical laboratory testing services is complex. We perform tests in advance of payment and without
certainty as to the outcome of the billing process. In cases where we expect to receive a fixed fee per test due to our
reimbursement arrangements, we may nevertheless encounter disputes over pricing and billing. Each third-party payer
typically has different billing requirements, and the billing requirements of many payers have become increasingly
difficult to meet. Among the factors complicating our billing of third-party payers are:
•
•
•
disparity in coverage among various payers;
disparity in information and billing requirements among payers, including with respect to prior
authorization requirements and procedures and establishing medical necessity; and
incorrect or missing billing information, which is required to be provided by the ordering healthcare
practitioner.
These risks related to billing complexities, and the associated uncertainty in obtaining payment for our tests,
could harm our business, financial condition and results of operations.
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In the United States, the AMA generally assigns specific billing codes for laboratory tests under a coding
system known as Current Procedure Terminology, or CPT, which we and our ordering healthcare providers must use to
bill and receive reimbursement for our diagnostic tests. Once the CPT code is established by the AMA, CMS establishes
payment levels and coverage rules under Medicare while private payers independently establish rates and coverage rules.
A CPT code specific to NIPT for aneuploidies, and a CPT code for microdeletions, are in place, and CMS has
established a pricing benchmark for aneuploidy and microdeletions testing. However, our microdeletions reimbursement
has decreased since the implementation of the microdeletions CPT code because third-party payers are declining to
reimburse under this code or reimbursing at a much lower rate than we had previously received. Furthermore, we cannot
guarantee that we will be able to negotiate favorable rates for this code or receive reimbursement at all if we are unable
to collect and publish additional data and obtain positive coverage determinations for Panorama for microdeletions. In
addition, a CPT code for expanded carrier screening tests has been implemented, which may similarly cause
reimbursement for our Horizon expanded carrier screening tests to decline. We do not currently have assay-specific CPT
codes assigned for all of our tests, and there is a risk that we may not be able to obtain such codes or, if obtained, we
may not be able to negotiate favorable rates for such codes. We currently submit for reimbursement using CPT codes
based on the guidance of outside coding experts and legal counsel. There is a risk that the codes we currently submit
may be rejected or withdrawn or that third-party payers will seek refunds of amounts that they claim were
inappropriately billed based on either the CPT code used, or the number of units billed. In addition, third-party payers
may not establish positive coverage policies for our tests or adequately reimburse for any CPT code we may use, or seek
recoupment for testing previously performed, which have occurred in the past.
If the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with
trying to obtain premarket clearance or approval and incur costs associated with complying with post-market
controls.
We currently offer a number of genetic tests, and each of those tests is an LDT. An LDT is generally considered
to be a test that is designed, developed, validated and used within a single laboratory. The FDA takes the position that it
has the authority to regulate such tests as medical devices under the FDC Act, but it has generally exercised enforcement
discretion with regard to LDTs. This means that even though the FDA believes it can impose regulatory requirements on
LDTs, such as requirements to obtain premarket approval or clearance of LDTs, it has generally chosen not to enforce
those requirements to date.
The regulation by the FDA of LDTs remains uncertain. In October 2014, the FDA issued draft guidances
outlining its plan to actively regulate LDTs using a risk-based approach. In November 2016, the FDA announced that it
no longer plans to finalize the 2014 draft guidances. In January 2017, the FDA issued a discussion paper that laid out
elements of a possible revised future LDT regulatory framework, but did not establish any regulatory requirements. The
FDA has also sought to restrict the marketing of a number of LDTs used for pharmacogenomics. The FDA’s efforts to
regulate LDTs prompted the drafting of legislation governing diagnostic products and services that sought to
substantially revamp the regulation of both LDTs and IVDs. Congress may still act to provide further direction to the
FDA on the regulation of LDTs and substantially modify the regulation of IVDs.
In the meantime, the FDA could require us to seek premarket clearance, approval or authorization to offer our
tests for clinical use even before it finalizes any future guidance. If FDA premarket clearance, approval or authorization
is required for any of our existing or future tests, we may be forced to stop selling our tests or we may be required to
modify claims or make other changes to our tests while we work to obtain FDA clearance, approval or authorization.
Our business would be adversely affected while such review is ongoing and if we are ultimately unable to obtain
premarket clearance, approval or de novo authorization. For example, the regulatory premarket clearance, approval or de
novo authorization process may involve, among other things, successfully completing analytical, pre-clinical and/or
clinical studies beyond the studies we have already performed or plan to perform for each of our products and would
involve submitting a premarket notification, or 510(k), a de novo application, or filing a PMA application with the FDA.
As further described in the risk factor entitled “Uncertainty in the development and commercialization of our enhanced
or new tests or services could materially adversely affect our business, financial condition and results of operations,”
completing such studies requires the expenditure of time, attention and financial and other resources, and may not yield
the desired results, which may delay, limit or prevent regulatory clearances, approvals or authorizations. In addition, we
may require cooperation in our filings for FDA clearance, approval or authorization from third-party manufacturers of
the components of our tests. If we are unable to obtain such required cooperation, we may be unable to achieve the
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desired regulatory clearances, approvals or authorizations, or may be delayed or be required to expend additional costs
and other resources in doing so. For example, Illumina currently is our sole sequencer and sequencing reagent supplier.
If we seek to achieve regulatory clearance, approval or authorization for Panorama, to the extent that Panorama
incorporates Illumina’s sequencer or sequencing reagents, we may require Illumina’s cooperation in the regulatory
process. We may face difficulty obtaining cooperation from Illumina because Illumina is the parent company of
Verinata, a direct competitor of ours in the NIPT field. In addition, we are party to certain litigation with Illumina as
described in “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to Consolidated Financial
Statements. Furthermore, if FDA premarket clearance, approval or de novo authorization is required, our cash flows may
be adversely affected until we obtain such clearance, approval or authorization, as most third-party payers, including
Medicaid, will not reimburse for use of medical devices which are required to be cleared or approved but which have not
been.
In May 2019, the FDA granted Breakthrough Device designation for our Signatera test for use in the
post-surgical detection and quantification of ctDNA in the blood of patients previously diagnosed with certain types of
cancer and in combination with certain drugs, which will enable us to have increased interactions with FDA. We cannot
assure you that this designation will lead to accelerated review or approval of our regulatory submissions for Signatera.
We cannot assure you that Panorama or any of our other tests for which we decide to pursue or are required to
obtain premarket clearance, approval or de novo authorization by the FDA will be cleared, approved or authorized on a
timely basis, if at all. In addition, if a test has been cleared, approved or authorized, certain kinds of changes that we may
make to improve the test, or as a result of issues with suppliers of the components of the test or if a supplier modifies its
component upon which our approval relies, may need to be cleared, approved or authorized by the FDA before we can
implement them, which could increase the time and expense involved in rolling such changes out to the commercial
market. Ongoing compliance with FDA regulations would increase the cost of conducting our business and subject us to
heightened regulation by the FDA and penalties for failure to comply with these requirements, any of which may
adversely impact our business and results of operations.
Furthermore, the FDA or the Federal Trade Commission, or FTC, may object to the materials and methods we
use to promote the use of our current tests or other LDTs we may develop in the future, including with respect to the
product claims in our promotional materials, and may initiate enforcement actions against us. Enforcement actions by
the FDA may include, among others, untitled or warning letters; fines; injunctions; civil or criminal penalties; recall or
seizure of current or future tests, products or services; operating restrictions and partial suspension or total shutdown of
production. Enforcement actions by the FTC may include, among others, injunctions, civil penalties, and equitable
monetary relief.
Failure to obtain necessary regulatory approvals may adversely affect our ability to expand our operations
internationally, including our ability to continue commercializing our cloud-based distribution model.
An important part of our business strategy is to expand and offer our tests internationally, either by providing
our testing services directly or through our laboratory partners, or through our licensees under our Constellation
cloud-based distribution model. As we do so, we will become increasingly subject to or impacted by the regulatory
requirements of foreign jurisdictions, which are varied and complex. Our tests, and certain components of our tests, may
be subject to the regulatory approval requirements in each foreign country in which they are sold by us or a laboratory
partner, or by our licensees under our cloud-based distribution model, and our future performance would depend on us or
our partners or licensees obtaining any necessary regulatory approvals in a timely manner. For example, while we have
entered into a license agreement with BGI Genomics to commercialize our Signatera test in China and to develop
reproductive health tests in select markets using BGI Genomics’s sequencing instruments and platform, such
commercialization and development activities will be subject to obtaining and maintaining necessary regulatory
approvals in the relevant jurisdictions. In addition, while we have obtained a CE Mark from the European Commission
for our Constellation software and the key reagents required for our licensees to run their NIPT based on our technology,
we have not obtained a CE Mark for our Panorama test as a whole. Therefore, while we are able to offer Constellation in
the European Union and other countries that accept a CE Mark, we are unable to offer Panorama as an IVD directly in
these jurisdictions. This, coupled with our use of our Panorama brand name under our Constellation model, has caused
regulatory authorities to question whether we, our laboratory partners or our licensees may be marketing,
commercializing or otherwise offering our tests without required approvals. We are occasionally required to address
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inquiries from regulatory authorities in various countries, such as those in the European Union, regarding the regulatory
status of our Panorama or Constellation offerings, and expect that we will continue to face similar inquiries. If we do not
continue to satisfactorily address any such questions in the future, we may be required to cease offering our products,
either directly or through our partners or licensees, in the relevant country. This may in turn result in similar concerns,
and subsequent cessation of our sources of revenue, in other countries.
We may also be at a competitive disadvantage in the European Union to our competitors who have obtained a
CE Mark for their end to end NIPT. In addition, as further described in the risk factor entitled “Risks Related to Our
Business and Industry—We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our
laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative
suppliers,” blood collection tubes sourced solely from Streck are required to run our tests. These blood collection tubes
are CE Marked by the European Commission; however, if such blood collection tubes are not registered in jurisdictions
that do not accept a CE Mark, we may be unable to expand our business in such jurisdictions.
We may also need to obtain regulatory clearance, approval or authorization in the United States for our
Constellation software in order for it to be used by third parties in the development and commercialization of their
diagnostic tests based on our technology. We have discussed with the FDA the regulatory status of a portion of our
Constellation software, the copy number calculator, or CNC, to make calls of copy number variants, which are genetic
mutations in which relatively large regions of the genome have been deleted or duplicated. The FDA has indicated that
the CNC may be appropriate for review under the de novo classification process, which is less burdensome than the
premarket approval, or PMA, process. The FDA stated that it would not prevent us from marketing Constellation in the
United States while we discuss with the FDA how it will be regulated; however, it is possible that the FDA may reverse
itself either on the appropriate regulatory review path or on the issue of our ability to continue to market Constellation.
In addition, the 21st Century Cures Act, enacted in 2016, included a number of changes to the FDA’s regulatory
approach to software that may have bearing on the regulatory status of our Constellation software. We cannot guarantee
that we will be able to obtain such clearance, approval or authorization for our Constellation software, in the event that
we are required to do so. If we are unable to do so, we would be unable to commercialize our cloud-based distribution
model in the United States. If we are able to do so, we will be subject to ongoing FDA obligations and continued
regulatory oversight and review, including compliance with requirements such as the quality system regulation, or QSR,
which establishes extensive requirements for quality assurance and control as well as manufacturing procedures; the
listing of our devices with the FDA; adverse event and malfunction reporting; corrections and removals reporting; and
labeling and promotional requirements. We may also be subject to additional FDA post-marketing obligations. If we are
not able to maintain regulatory compliance to the extent required, we may not be permitted to offer our Constellation
software and may be subject to enforcement action by the FDA, such as the issuance of warning or untitled letters, fines,
injunctions and civil penalties; recall or seizure of products; operating restrictions and criminal prosecution.
Regulatory approval can be a lengthy, expensive and uncertain process. In addition, regulatory processes are
subject to change, and new or changed regulations can result in unanticipated delays and cost increases. For example, the
European Commission has adopted revised in-vitro diagnostic regulations, or IVDR, which are expected to become
effective in 2022. Among others, the new regulations introduce risk-based classification for IVDs and will require
notified body involvement for various classes of devices, including reproductive health tests such as Panorama, which
will be classified as a Class C product. As such, we will also be required to submit clinical evidence and post-market
performance data to regulators. We or our partners or licensees may not be able to obtain regulatory approvals on a
timely basis, if at all, which may cause us to incur additional costs or prevent us from marketing our tests in the United
States or in foreign countries.
Changes in laws and regulations, or in their application, may adversely affect our business, financial condition and
results of operations.
The clinical laboratory testing industry is highly regulated, and failure to comply with applicable regulatory,
supervisory, accreditation, registration or licensing requirements may adversely affect our business, financial condition
and results of operations. In particular, the laws and regulations governing the marketing and research of clinical
diagnostic testing are extremely complex and in many instances there are no clear regulatory or judicial interpretations of
these laws and regulations, increasing the risk that we may be found to be in violation of these laws.
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Furthermore, the molecular diagnostics industry as a whole is a growing industry and regulatory agencies such
as the United States Department of Health and Human Services, or HHS, or the FDA may apply heightened scrutiny to
new developments in the field. While we have taken steps to ensure compliance with the current regulatory regime in all
material respects, given its nature and our geographical diversity, there could be areas where we are non-compliant. Any
change in the federal or state laws or regulations relating to our business may require us to implement changes to our
business or practices, and we may not be able to do so in a timely or cost-effective manner. Should we be found to be
non-compliant with current or future regulatory requirements, we may be subject to sanctions which could include
changes to our operations, adverse publicity, substantial financial penalties and criminal proceedings, which may
adversely affect our business, financial condition and results of operations by increasing our cost of compliance or
limiting our ability to develop, market and commercialize our tests.
In addition, there has been a recent trend of increased U.S. federal and state regulation, scrutiny and
enforcement relating to payments made to referral sources, which are governed by laws and regulations including the
Stark law, the federal Anti-Kickback Statute, the federal False Claims Act, and EKRA as well as state equivalents of
such laws. Among other requirements, the Stark law requires laboratories to track, and places a cap on, non-monetary
compensation provided to referring physicians.
While we have a compliance plan to address compliance with government laws and regulations, including
applicable fraud and abuse laws and regulations such as those described in this risk factor, the evolving commercial
compliance environment and the need to build and maintain robust and scalable systems to comply with regulations in
multiple jurisdictions with different compliance and reporting requirements increases the possibility that we could
inadvertently violate one or more of these requirements.
If we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to
perform our tests or experience disruptions to our business.
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 require clinical laboratories to obtain a certificate and mandate specific standards in the areas of
personnel qualifications, administration, participation in proficiency testing, patient test management and quality
assurance. CLIA certification is also required in order for us to be eligible to bill state and federal healthcare programs,
as well as many private third-party payers, for our tests. Our laboratory located in San Carlos, California is CLIA
certified, and is accredited by the College of American Pathologists, or CAP, a CMS-approved accreditation
organization. To renew these certifications, we are subject to survey and inspection every two years. Moreover, CLIA
and/or state inspectors may conduct random inspections of our clinical laboratory or conduct an inspection as a result of
a complaint or reported incident, as has occurred. Any failure to address identified deficiencies, or to otherwise comply
with CLIA, CAP or state requirements, can result in enforcement actions, including the revocation, suspension, or
limitation of our CLIA and/or CAP certificate of accreditation or state laboratory permit, as well as a directed plan of
correction, on-site monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties, suspension
or exclusion from the Medicare and Medicaid programs and significant adverse publicity. Bringing our laboratory back
into compliance with CLIA requirements could cause us to incur significant expenses and potentially lose revenues in
order to address deficiencies and achieve compliance.
Some states require that we hold licenses or permits to test samples from patients in those states and as a result
we are also required to maintain standards related to state licensure to conduct testing in our laboratories under state law.
California state laboratory laws and regulations establish standards for the operation of our clinical laboratory and
performance of test services in San Carlos, California; and all personnel involved in testing must maintain a California
state license or be supervised by licensed personnel. We maintain a license in good standing with the California
Department of Public Health, or CAPH. In addition, because we receive test specimens originating from New York, we
have obtained a state laboratory permit for our San Carlos laboratory from the New York Department of Health, or
DOH, which mandates proficiency testing regardless of whether the laboratory is physically located in New York. The
New York state laboratory laws, regulations and rules are at least as stringent than the CLIA regulations and establish
standards for the operation of a clinical laboratory and performance of test services; and the laboratory director must
maintain a Certificate of Qualification issued by New York’s DOH. As under CLIA, we are subject to routine on-site
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inspections or inspections in response to a complaint under both California and New York state laboratory laws and
regulations. If we are found to be out of compliance with either California or New York requirements, CAPH or New
York’s DOH may suspend, restrict or revoke our license or laboratory permit, respectively (and, with respect to
California, may exclude persons or entities from owning, operating or directing a laboratory for two years following
such license revocation), assess civil monetary penalties, or impose specific corrective action plans, among other
sanctions. We cannot assure you that the regulators in any state from which we have obtained a required license or
permit will at all times find us to be in compliance with the applicable laws of their respective state, which may result in
suspension, limitation, revocation or annulment of our laboratory’s license for that state or negative impact to our CLIA
certificate, censure, or civil monetary penalties, and would result in our inability to test samples from patients in that
state. Any such consequences could materially and adversely affect our business by prohibiting or limiting our ability to
offer testing.
Changes in government healthcare policy could increase our costs and negatively impact coverage and
reimbursement for our tests by governmental and other third-party payers.
The U.S. government has shown significant interest in pursuing healthcare reform and reducing healthcare
costs. Government healthcare policy has been and will likely continue to be a topic of extensive legislative and executive
activity in the U.S. federal government and many U.S. state governments. As a result, our business could be affected by
significant and potentially unanticipated changes in government healthcare policy, such as changes in reimbursement
levels by government third-party payers. Any such changes could substantially impact our revenues, increase costs and
divert management attention from our business strategy. We cannot predict the impact, if any, of governmental
healthcare policy changes on our business, financial condition and results of operations.
In the United States, the Patient Protection and Affordable Care Act, as amended by the Healthcare and
Education Reconciliation Act of 2010, or collectively, the PPACA, was signed into law in March 2010 and significantly
impacted the U.S. pharmaceutical and medical device industries, including the diagnostics sector, in a number of ways.
Among other things, the PPACA expanded healthcare fraud and abuse laws such as the False Claims Act and the
Anti-Kickback Statute, including but not limited to required disclosures of financial arrangements with physician
customers, required reporting of discovered overpayments, lower thresholds for violations, new government
investigative powers, and enhanced penalties for such violations. The PPACA restricts insurers from charging higher
premiums or denying coverage to individuals with pre-existing conditions, and requires insurers to cover certain
preventative services without charging any copayment or coinsurance, including screening for lung, breast, colorectal
and cervical cancers. However, there have been multiple attempts to repeal PPACA or significantly scale back its
applicability, which could negatively impact reimbursement for our testing. This could adversely affect our test volumes
and, in turn, our business, financial condition, results of operations, and cash flows. For example the Tax Cuts and Jobs
Act of 2017, or the Tax Act, repeals the requirement under PPACA that consumers buy insurance or pay a penalty unless
they qualified for an applicable exemption. The repeal of this mandate means that fewer consumers may carry insurance
coverage and therefore may be less likely to elect to receive our testing because they would be required to pay out of
pocket for such tests, which could impact our test volumes and adversely affect our business, financial condition, results
of operations, and cash flows. The PPACA also created a new system of health insurance “exchanges” designed to make
health insurance available to individuals and certain groups through state- or federally-administered marketplaces in
addition to existing channels for obtaining health insurance coverage. If Panorama or any of our other tests are not
covered by plans offered in the health insurance exchanges, our business, financial condition and results of operations
could be adversely affected. Furthermore, various proposed legislative initiatives with respect to the PPACA, including
possible repeal of the PPACA, have resulted in considerable uncertainty and concern regarding, for example, a patient’s
election to undergo genetic screening and whether doing so may impact health insurance eligibility. Because it is unclear
whether or how the PPACA may change, and whether and to what extent NIPT, cancer screening or other genetic
screening may be affected, we are uncertain how our business may be impacted.
In addition to the PPACA, various healthcare reform proposals have also emerged from federal and state
governments. The Protecting Access to Medicare Act of 2014, or PAMA, introduced a multi-year pricing program for
services payable under the CLFS that is designed to bring Medicare allowable amounts in line with the often lower
negotiated payment rates paid by private payers. The implementation of the PAMA rates have negatively impacted
overall pricing and reimbursement for many clinical laboratory testing services and continue to be the subject of
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controversy in the industry. We believe that the new rates under PAMA will have minimal impact on our business in the
near term because our revenues from Medicare are currently very low; however, we expect the new rates to have greater
impact on us as we begin billing for our Signatera and Propera testing. In addition, federal budgetary limitations and
changes in healthcare policy, such as the creation of broad limits for our tests and requirements that beneficiaries of
government health plans pay for, or pay for higher portions of, clinical laboratory tests or services received, could
substantially diminish the utilization of our tests, increase costs and adversely affect our ability to generate revenues and
achieve profitability.
We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or how
any such future legislation, regulation or initiative may affect us. Current or potential future federal legislation and the
expansion of government’s role in the U.S. healthcare industry, as well as changes to the reimbursement amounts paid
by third-party payers for our current and future tests, may adversely affect our test volumes and adversely affect our
business, financial condition, results of operations, and cash flows.
If we or our laboratory distribution partners, consultants or commercial partners act in a manner that violates
healthcare fraud and abuse laws or otherwise engage in misconduct, we may be subject to civil or criminal penalties.
We are subject to healthcare fraud and abuse regulation and enforcement by both the U.S. federal government
and the states in which we conduct our business, including:
• HIPAA, which created federal civil and criminal laws that prohibit executing a scheme to defraud any
healthcare benefit program or making false statements relating to healthcare matters and also imposes
significant obligations with respect to maintenance of the privacy and security, and transmission, of
individually identifiable health information;
•
•
•
•
•
•
federal and state laws and regulations governing informed consent for genetic testing and the use of genetic
material;
federal and state laws and regulations governing the submission of claims, as well as billing and collection
practices, for healthcare services;
the federal Anti-Kickback Statute, which prohibits, among other things, the knowing and willful
solicitation, receipt, offer or payment of remuneration, directly or indirectly, in exchange for or to induce
either the referral of an individual for, or the purchase, order or recommendation of, any good or service for
which payment may be made under federal healthcare programs such as Medicare;
the federal False Claims Act which prohibits, among other things, the presentation of false or fraudulent
claims for payment from Medicare, Medicaid, or other government-funded third-party payers;
federal laws and regulations governing the Medicare program, providers of services covered by the
Medicare program, and the submission of claims to the Medicare program, as well as the Medicare
Manuals issued by CMS and the local medical policies promulgated by the Medicare Administrative
Contractors with respect to the implementation and interpretation of such laws and regulations;
the federal Stark law, also known as the physician self-referral law, which, subject to certain exceptions,
prohibits a physician from making a referral for certain designated health services covered by the Medicare
program (and according to case law in some jurisdictions, the Medicaid program as well), 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;
•
the federal Civil Monetary Penalties Law, which, subject to certain exceptions, prohibits, among other
things, the offer or transfer of remuneration to a Medicare or state healthcare program beneficiary if the
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•
•
•
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;
the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, which, among other things, prohibits the
knowing or willful payment or offer, or the solicitation or receipt, of any remuneration, whether directly or
indirectly, overtly or covertly, in cash or in kind, in exchange for the referral or inducement of laboratory
testing;
the prohibition on reassignment by the program beneficiary of Medicare claims to any party; and
state law equivalents of the above U.S. federal laws, such as the Stark law, Anti-Kickback Statute and false
claims laws, which may apply to items or services reimbursed by any third-party payer, including
commercial insurers, and state data privacy and security laws and which may be more stringent than
HIPAA.
Furthermore, a development affecting our industry is the increased enforcement of the federal False Claims Act
and, in particular, actions brought pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. The False
Claims Act imposes liability for, among other things, knowingly presenting, or causing to be presented, a false or
fraudulent claim for payment by a federal governmental payer program. The qui tam provisions of the False Claims Act
allow a private individual to bring civil actions on behalf of the federal government for violations of the False Claims
Act and permit such individuals to share in any amounts paid by the defendant to the government in fines or settlement.
When an entity is determined to have violated the False Claims Act, it is subject to mandatory damages of three times
the actual damages sustained by the government, plus mandatory civil penalties of up to approximately $22,363 for each
false claim. In addition, various states have enacted false claim laws analogous to the federal False Claims Act, and in
some cases go even further because many of these state laws apply where a claim is submitted to any third-party payer
and not merely a governmental payer program. For example, in 2018 we reached a settlement with certain government
payers regarding past reimbursement submissions. Although the settlement involved no admission of fault by us and no
corporate integrity agreement, we cannot guarantee that we will not be subject to similar claims in the future.
Many of these laws and regulations have not been fully interpreted by regulatory authorities or the courts, and
their provisions are open to a variety of interpretations. We have adopted policies and procedures designed to comply
with these laws, and in the ordinary course of our business, we conduct internal reviews of our compliance with these
laws. However, the rapid growth and expansion of our business both within and outside of the United States may
increase the potential for violating these laws or our internal policies and procedures, and the uncertainty around the
interpretation of these laws and regulations increases the risk that we may be found in violation of these or other laws
and regulations, or of allegations of such violations, including pursuant to private qui tam actions brought by individual
whistleblowers in the name of the government as described above. If our operations, including the conduct of our
employees, distributors, consultants and commercial partners, are found to be in violation of any laws or regulations that
apply to us, we may be subject to penalties, including civil, criminal and administrative penalties, damages, fines,
disgorgement of profits, exclusion from participation in government programs, injunctions, recall or seizure of products,
total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, contractual damages,
reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations, any of
which could materially and adversely affect our business, financial condition and results of operations.
Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to our
reputation and have a material adverse effect on our business.
The federal HIPAA privacy and security regulations, including the expanded requirements under the Health
Information Technology for Economic and Clinical Health Act, or HITECH, which was enacted as part of the American
Recovery and Reinvestment Act of 2009, establish comprehensive federal standards with respect to the use and
disclosure of protected health information by health plans, healthcare providers, and healthcare clearinghouses, in
addition to setting standards to protect the confidentiality, integrity and security of protected health information. The
regulations establish a complex regulatory framework on a variety of subjects, including patient authorization of the use
and disclosure of, administrative, technical and physical safeguards for, and analysis of security incidents and breach
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notification requirements with respect to, protected health information. HIPAA, as amended by HITECH, provides for
significant fines and other penalties for wrongful use or disclosure of protected health information in violation of privacy
and security regulations, including potential civil and criminal fines and penalties.
The HIPAA privacy and security regulations establish minimum requirements, and do not supersede state laws
that are more stringent. A number of states include medical information in the definition of personal information and
have implemented requirements or standards more stringent than HIPAA. Therefore, while we have implemented
policies and procedures related to compliance with the HIPAA regulations, we are also required to comply with various
state privacy and security laws and regulations, and could incur penalties, compliance costs as a result of
non-compliance or damages under state laws pursuant to an action brought by a private party for the wrongful use or
disclosure of confidential health information or other private personal information. In addition, other federal and state
laws that protect the privacy and security of patient information may be subject to enforcement and interpretation by
various governmental authorities and courts, resulting in complex compliance issues.
The European Union’s data privacy regulations, the General Data Protection Regulation, or GDPR, became
subject to enforcement in May 2018. These regulations comprehensively reform the prior data protection rules of the
European Union, and are more stringent, provide for higher potential liabilities, and apply to a broader range of personal
data than those in the United States. The GDPR is applicable to U.S.-based companies, such as ours, that do business or
offer services in, or that process or hold personal data of data subjects in, the European Union. While our current
processes and practices comply with the GDPR, we will need to expend considerable time and resources, including
management attention, to continue to revise our practices to ensure ongoing compliance with GDPR. Furthermore, the
GDPR enables EU member states to enact jurisdiction-specific requirements in key areas, which could require us to
modify our plans to comply with the GDPR, or otherwise to implement multiple policies unique to the jurisdictions in
which we operate, which could make it more difficult and resource-intensive to continue to operate in the European
Union.
As we continue to expand and grow our business, our overall compliance with applicable laws and regulations
may result in increased costs and attention of management, and failure to comply may result in significant fines,
penalties and damage to our reputation. Additionally, the interpretation and application of health-related, privacy and
data protection laws are often uncertain, contradictory and in flux, and it is possible that these laws may be interpreted
and applied in a manner that is inconsistent with our practices. As a result, we could be subject to government-imposed
fines or orders requiring that we change our practices, which could cause us to incur substantial costs and may adversely
affect our business and our reputation.
Changes in the way the FDA regulates the reagents, other consumables, and testing equipment we use when
developing, validating, and performing our tests could result in delay or additional expense in bringing our tests to
market or performing such tests for our customers.
Many of the sequencers, reagents, kits and other consumable products used to perform our testing, as well as
the instruments and other capital equipment that enable the testing, are offered for sale for research use only, or RUO. In
addition, our Signatera (RUO) test is a research use only offering. Products that are intended for research use only and
are labeled as RUO are exempt from compliance with FDA requirements, including the approval, clearance or
authorization and other product quality requirements for medical devices. A product labeled RUO but which is actually
intended for clinical diagnostic use may be viewed by the FDA as adulterated and misbranded under the FDC Act and
subject to FDA enforcement action. The FDA has said that when determining the intended use of a product labeled
RUO, it will consider the totality of the circumstances surrounding distribution of the product, including how the product
is marketed and to whom. In addition, many of the reagents used to perform our testing are offered for sale as analyte
specific reagents, or ASRs. ASRs are medical devices and must comply with QSR provisions and other device
requirements, but most are exempt from 510(k) and PMA premarket review. The FDA could disagree with a supplier’s
assessment that the supplier’s products are ASRs, or could conclude that products labeled as RUO are actually intended
for clinical diagnostic use, and could take enforcement action against the supplier, such as us with respect to Signatera
(RUO), including requiring the supplier to cease offering the product while it seeks clearance, approval or authorization.
Suppliers of RUO products that we employ in our other tests may cease selling their respective products, and we may be
unable to obtain an acceptable substitute on commercially reasonable terms or at all, which could significantly and
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adversely affect our ability to provide timely testing results to our customers or could significantly increase our costs of
conducting business.
The sequencers and reagents supplied to us by Illumina and the blood collection tubes supplied to us by Streck
are labeled as RUO in the United States. We are using these sequencers, reagents and blood collection tubes for clinical
diagnostic use. If the FDA were to require clearance, approval or authorization for the sale of Illumina’s sequencers and
if Illumina does not obtain such clearance, approval or authorization, we would have to find an alternative sequencing
platform for Panorama. We currently have not validated an alternative sequencing platform on which Panorama could be
run in a commercially viable manner. If we were not successful in selecting, acquiring on commercially reasonable terms
and implementing an alternative platform on a timely basis, our business, financial condition and results of operations
would be adversely affected. Similarly, a decision by the FDA to require clearance, approval or authorization for the sale
by Streck of the blood collection tubes used for Panorama, or a finding that any of our other suppliers failed to comply
with applicable requirements, could result in interruptions in our ability to supply our products to the market and
adversely affect our operations.
Our use of hazardous materials in the development of our tests exposes us to risks related to accidental contamination
or injury and requires us to comply with regulations governing hazardous waste materials.
Our research and development activities involve the controlled use of hazardous materials and chemicals. We
cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage,
handling or disposal of these materials. In the event of contamination 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. In addition,
we are subject on an ongoing basis to federal, state and local regulations governing the use, storage, handling and
disposal of these materials and specified hazardous waste materials. An increase in the costs of compliance with such
laws and regulations could harm our business and results of operations.
If the validity of an informed consent from a patient intake for Panorama or our other tests is challenged, we could
be precluded from billing for such testing, forced to stop performing such tests, or required to repay amounts
previously received, which would adversely affect our business and financial results.
All clinical data and blood samples that we receive are required to have been collected from individuals who
have provided appropriate informed consent for us to perform our testing, both commercially and in clinical trials. We
seek to ensure that the individuals from whom the data and samples are collected do not retain or have conferred any
proprietary or commercial rights to the data or any discoveries derived from them. Our partners operate in a number of
different countries in addition to the United States, and, to a large extent, we rely upon them to comply with the
individual’s informed consent and with U.S. and international laws and regulations. The collection of data and samples
in many different states and foreign countries results in complex legal questions regarding the adequacy of informed
consent and the status of genetic material under a large number of different legal systems. The individual’s informed
consent obtained in any particular country could be challenged in the future, and those informed consents could be
deemed invalid, unlawful or otherwise inadequate for our purposes. Any findings against us, or our partners, could deny
us access to, or force us to stop testing samples in, a particular country or could call into question the results of our
clinical trials. We could also be precluded from billing third-party payers for tests for which informed consents are
challenged, or could be requested to refund amounts previously paid by third-party payers for such tests. We could
become involved in legal challenges, which could require significant management and financial resources and adversely
affect our revenues and results of operations.
Risks Related to Our Intellectual Property
Litigation or other proceedings resulting from either third-party claims of intellectual property infringement, or
asserting infringement by third parties of our technology, is costly, time-consuming, and could limit our ability to
commercialize our products or services.
Our success depends in part on our non-infringement of the patents or intellectual property rights of third
parties, and our ability to successfully prevent third parties from infringing our intellectual property. We operate in a
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crowded technology area in which there has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the genetic diagnostics industry. Third parties, including our competitors, have asserted
and may in the future assert that we are infringing their intellectual property rights.
We are presently engaged in patent infringement lawsuits with Illumina, CareDX, and ArcherDX, as described
in “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to Consolidated Financial Statements.
We may become subject to and/or initiate future intellectual property litigation as our product portfolio, and the level of
competition in our industry segments, grow.
Should we be unsuccessful defending against patent infringement claims, we may be required to pay substantial
royalties, money damages, or be enjoined offering certain products or services. We may be required to change our
marketing practices, pay large damages awards, and in the case of patent infringement, pay unsustainably high royalties
to obtain licenses from third parties. In addition, we could experience delays in product introductions or sales growth
while we attempt to develop non-infringing alternatives. Any of these or other adverse outcomes could prevent us from
offering our tests or otherwise have a material adverse effect on our business, financial condition and our results of
operations.
We cannot predict whether, or offer any assurance that, the patent infringement claims we have initiated or may
initiate in the future will be successful. We may become subject to counterclaims by patent infringement defendants. Our
patents may be declared invalid or unenforceable, or narrowed in scope. Even if we prevail in an infringement action, we
cannot assure you that we would be adequately compensated for the harm to our business. If we are unable to enjoin
third-party infringement, our revenues may be adversely impacted and we may lose market share; and such third-party
product may continue to exist in the market, but fail to meet our regulatory or safety standards, thereby causing
irreparable harm to our reputation as a provider of quality products, which in turn could result in loss of market share
and have a material adverse effect on our business, financial condition and our results of operations.
In addition, our agreements with some of our customers, suppliers, and other entities with whom we do
business require us to defend or indemnify these parties to the extent they become involved in patent infringement
claims, including the types of claims described in this risk factor. We have agreed, and may in the future agree, to defend
or indemnify third parties if we determine it to be in the best interests of our business relationships. If we are required or
agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs
and expenses that could adversely affect our business, financial condition and results of operations.
Any inability to effectively protect our proprietary technologies could harm our competitive position.
Our success and ability to compete depend to a large extent on our ability to develop proprietary products and
technologies and to maintain adequate protection of our intellectual property in the United States and other countries;
this becomes increasingly important as we expand our operations and enter into strategic collaborations with partners to
develop and commercialize products. The laws of some foreign countries do not protect proprietary rights to the same
extent as the laws of the United States, and we may encounter difficulties in establishing and enforcing our proprietary
rights outside of the United States. In addition, the proprietary positions of companies developing and commercializing
tools for molecular diagnostics, including ours, generally are uncertain and involve complex legal and factual questions.
This uncertainty may materially affect our ability to defend or obtain patents or to address the patents and patent
applications owned or controlled by our collaborators and licensors.
We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that
our proprietary technologies are protected by valid and enforceable patents or are effectively maintained as trade secrets.
We have worked to procure patents protecting our technologies, but our procurement efforts may not always be
successful, and any patents we successfully procure may be challenged in ways that lead to post-procurement scope
reduction or invalidity. These challenges may impede our ability to protect our proprietary rights from unauthorized use.
In addition, any finding that others have claims of 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.
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Certain of our intellectual property was partly supported by a U.S. government grant awarded by the National
Institutes of Health, and the government accordingly has certain rights in this intellectual property, including a
non-exclusive, non-transferable, irrevocable worldwide license to use applicable inventions for any governmental
purpose. Such rights also include “march-in” rights, which refer to the right of the U.S. government to require us to grant
a license to the technology to a responsible applicant if we fail to achieve practical application of the technology or if
action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to
U.S. industry.
Any of these factors could adversely affect our ability to obtain commercially relevant or competitively
advantageous patent protection for our products.
If we are not able to adequately protect our trade secrets and other proprietary information, the value of our
technology and products could be significantly diminished.
We rely on trade secret and proprietary know-how protection for our confidential and proprietary information
and have taken security measures to protect this information. These measures, however, may not provide adequate
protection. For example, we have a policy of requiring our consultants, advisors and collaborators, including, for
example, our strategic collaborators with whom we seek to develop and commercialize products, to enter into
confidentiality agreements and our employees to enter into invention, non-disclosure and non-compete agreements.
However, breaches of our physical or electronic security systems, or breaches caused by our employees failing to abide
by their confidentiality obligations during or upon termination of their employment with us, could compromise these
protection efforts. Any action we take to enforce our rights may be time-consuming, expensive, and possibly
unsuccessful. Even if successful, the resulting remedy may not adequately compensate us for the harm caused by the
breach. These risks are heightened in countries where laws or law enforcement practices may not protect proprietary
rights as fully as in the United States or Europe. Any unauthorized use or disclosure of, or access to, our trade secrets,
know-how or other proprietary information, whether accidentally or through willful misconduct, could have a material
adverse effect on our programs and our strategy, and on our ability to compete effectively.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our
markets of interest, and our business may be adversely affected.
Failure to maintain our trademark registrations, or to obtain new trademark registrations in the future, could
limit our ability to protect our trademarks and impede our marketing efforts in the countries in which we operate. We
may not be able to protect our rights to trademarks and trade names which we may need to build name recognition with
potential partners or customers in our markets of interest. As a means to enforce our trademark rights and prevent
infringement, we may be required to file trademark claims against third parties or initiate trademark opposition
proceedings. This can be expensive and time-consuming, and possibly unsuccessful. Our registered or unregistered
trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to infringe on
other marks.
Our pending trademark applications in the United States and in other foreign jurisdictions where we may file
may not be successful. Even if these applications result in registered trademarks, third parties may challenge these
trademarks in the future. Over the long term, if we are unable to establish name recognition based on our trademarks and
trade names, then we may not be able to compete effectively and our business may be adversely affected.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or
disclosed confidential information of third parties.
We employ individuals who were previously employed at other biotechnology or diagnostic
companies. We may be subject to claims that we or our employees, consultants or independent contractors have
inadvertently or willfully used or disclosed confidential information of our employees’ former employers or other third
parties. We may also be subject to claims that our employees’ former employers or other third parties have an ownership
interest in our patents. Litigation may be necessary to defend against these claims, and if we are unsuccessful, we could
be required to pay substantial damages and could lose rights to important intellectual property. Even if we are successful,
65
litigation could result in substantial costs to us and could divert the time and attention of our management and other
employees.
Risks Related to Ownership of Our Common Stock
The market price of our common stock has been and may be volatile, which could subject us to litigation.
The trading prices of the securities of life sciences companies, including ours, have been and may continue to
be highly volatile. Accordingly, the market price of our common stock is likely to be subject to wide fluctuations in
response to numerous factors, many of which are beyond our control, such as those in this “Risk Factors” section and
others including:
•
•
•
•
•
•
•
•
actual or anticipated variations in our and our competitors’ results of operations, as well as how those
results compare to analyst and investor expectations;
announcements by us or our competitors of new products, significant acquisitions, other strategic
transactions, including strategic and commercial partnerships and relationships, joint ventures, divestitures,
collaborations or capital commitments;
failure of analysts to initiate or maintain coverage of our company, issuance of new securities analysts’
reports or changed recommendations for our stock;
forward-looking statements related to our financial guidance or projections, our failure to meet or exceed
our financial guidance or projections or changes in our financial guidance or projections;
commencement of, or our involvement in, litigation;
announcement or expectation of additional debt or equity financing efforts;
any major change in our management; and
general economic conditions and slow or negative growth of our markets.
In addition, if the market for life sciences stocks or the stock market in general experiences uneven investor
confidence, the market price of our common stock could decline for reasons unrelated to our business, operating results
or financial condition. The market price of our common stock might also decline in reaction to events that affect other
companies within, or outside, our industry even if these events do not directly affect us. Some companies that have
experienced volatility in the trading price of their stock have been the subject of securities class action litigation. For
example, as described in “Note 8—Commitments and Contingencies—Legal Proceedings” in the Notes to Consolidated
Financial Statements, a purported securities class action lawsuit had been filed against us, our directors and certain of
our officers and stockholders. Under certain circumstances, we have contractual and other legal obligations to indemnify
and to incur legal expenses on behalf of current and former directors and officers, and on behalf of our current or former
underwriters, in connection with the litigation described in Note 8 in the Notes to Consolidated Financial Statements and
in connection with any future lawsuits. Any lawsuit to which we are a party, with or without merit, may result in an
unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms. Any such negative outcome could
result in payments of substantial damages or fines, damage to our reputation or adverse changes to our offerings or
business practices. Defending against litigation is costly and time-consuming, and could divert our management’s
attention and resources. Furthermore, during the course of litigation, there could be negative public announcements of
the results of hearings, motions or other interim proceedings or developments, which could have a material adverse
effect on the market price of our common stock.
66
Commencing December 31, 2019, we are no longer an “emerging growth company,” and the reduced disclosure
requirements applicable to emerging growth companies no longer apply to us.
As of December 31, 2019, we ceased to qualify as an “emerging growth company”, as defined by the Jumpstart
Our Businesses Act of 2012, or the JOBS Act because as of June 30, 2019, the market value of our common stock that
was held by non-affiliates exceeded $700 million. As a result, we are no longer permitted to take advantage of reduced
regulatory and reporting requirements that are otherwise generally applicable to public companies. These include, not
being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced
disclosure obligations regarding executive compensation, and exemptions from the requirements of holding non-binding
advisory votes on executive compensation and golden parachute payments. As we are no longer an emerging growth
company, we expect to incur additional expenses and devote substantial management effort toward ensuring compliance
with those requirements applicable to companies that are not emerging growth companies. Compliance with these
additional laws, rules and regulations has and will continue to increase our legal and financial compliance costs, make
some activities more difficult, time consuming or costly and increase demand on our systems and resources. In addition,
management’s attention may be diverted from other business concerns and our costs and expenses will increase, which
could harm our business and operating results. We may also need to hire more employees in the future or engage
additional outside consultants to comply with these requirements, which will increase our costs and expenses.
If we are unable to implement and maintain effective internal controls over financial reporting in the future,
investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our
common stock could be adversely affected.
As a public company, we are required to maintain internal controls over financial reporting and to report any
material weaknesses in such internal controls. Section 404 of the Sarbanes-Oxley Act requires that we evaluate and
determine the effectiveness of our internal controls over financial reporting and provide a management report on internal
controls over financial reporting. The Sarbanes-Oxley Act also requires that our management report on internal controls
over financial reporting be attested to by our independent registered public accounting firm, beginning with this annual
report on Form 10-K.
Although we determined that our internal control over financial reporting was effective as of December 31,
2019, we must continue to monitor and assess our internal controls over financial reporting. If we have a material
weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our financial
statements may be materially misstated. If we identify material weaknesses in our internal controls over financial
reporting, if we are unable to comply with the requirements of Section 404 in a timely manner, if we are unable to assert
that our internal controls over financial reporting are effective, or, when required in the future, if our independent
registered public accounting firm is unable to express an opinion as to the effectiveness of our internal controls over
financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the
market price of our common stock could be adversely affected, and we could become subject to investigations by the
stock exchange on which our securities are listed, the SEC, or other regulatory authorities.
We do not intend to pay dividends on our capital stock so any returns will be limited to changes in the value of our
common stock.
We have never declared or paid any cash dividends on our capital stock. We currently anticipate that we will
retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or
paying any cash dividends for the foreseeable future. In addition, our ability to pay cash dividends on our capital stock
may be prohibited or limited by the terms of any current or future debt financing arrangement. Any return to
stockholders will therefore be limited to the increase, if any, in the price of our common stock.
67
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our
equity incentive plans or in connection with acquisitions or strategic or commercial transactions, could result in
additional dilution of the percentage ownership of our stockholders and could cause the price of our common stock to
decline.
From time to time, we may issue additional securities or sell common stock, convertible securities or other
equity securities in one or more transactions at prices and in a manner we determine. We also expect to continue to issue
common stock to employees and directors pursuant to our equity incentive plans. If we sell or issue common stock,
convertible securities or other equity securities in subsequent transactions, or common stock is issued pursuant to equity
incentive plans, investors may be materially diluted. We may decide to issue common stock or other equity securities in
connection with an acquisition or a strategic or commercial transaction, which could cause dilution to our existing
stockholders. New investors in such subsequent transactions could gain rights, preferences and privileges senior to those
of holders of our common stock.
Sales of a substantial number of shares of our common stock in the public markets could cause the price of our
common stock to decline.
Sales of a substantial number of shares of our common stock in the public market or the perception that these
sales might occur could depress the market price of our common stock and could impair our ability to raise capital
through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing
market price of our common stock.
We may issue our shares of common stock or securities convertible into our common stock from time to time in
connection with a financing, acquisition, investments or otherwise. Any such issuance could result in substantial dilution
to our existing stockholders and cause the trading price of our common stock to decline.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our
business, our stock price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry
analysts publish about us or our business. Currently, only a small number of securities analysts cover our stock. If more
analysts do not commence coverage of us, or if industry analysts cease coverage of us or fail to publish reports on us
regularly, the trading price for our common stock could be adversely affected. If one or more of the analysts who cover
us downgrade our common stock or publish inaccurate or unfavorable research about our business, our common stock
price would likely decline.
Insiders have substantial control over us and will be able to influence corporate matters.
As of December 31, 2019, our directors and executive officers and their affiliates beneficially owned, in the
aggregate, approximately 14.09% of our outstanding capital stock. As a result, these stockholders are and will continue
to be able to exercise significant influence over all matters requiring stockholder approval, including the election of
directors and approval of significant corporate transactions, such as a merger or other sale of our company or its assets.
This concentration of ownership could limit stockholders’ ability to influence corporate matters and may have the effect
of delaying or preventing a third party from acquiring control over us.
Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and
Delaware law might discourage, delay or prevent a change in control of our company or changes in our management
and, therefore, depress the market price of our common stock.
Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that
could depress the market price of our common stock by acting to discourage, delay or prevent a change in control of our
company or changes in our management that the stockholders of our company may deem advantageous. These
provisions, among other things:
68
•
•
•
•
•
•
•
•
•
authorize the issuance of “blank check” preferred stock that our board of directors could use to implement a
stockholder rights plan;
prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a
meeting of our stockholders;
eliminate the ability of our stockholders to call special meetings of stockholders;
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;
establish a classified board of directors so that not all members of our board are elected at one time;
permit the board of directors to establish the number of directors;
provide that directors may only be removed “for cause” and only with the approval of 75% of our
stockholders;
require super-majority voting to amend some provisions in our amended and restated certificate of
incorporation and amended and restated bylaws; and
provide that the board of directors is expressly authorized to make, alter or repeal our amended and restated
bylaws.
In addition, Section 203 of the Delaware General Corporation Law may discourage, delay or prevent a change
in control of our company. Section 203 imposes certain restrictions on mergers, business combinations and other
transactions between us and holders of 15% or more of our common stock.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is
the exclusive forum 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 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 pursuant to the Delaware General Corporation
Law or any action asserting a claim against us that is governed by the internal affairs doctrine. This choice of forum
provision 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 and may discourage these types of lawsuits. Alternatively, if a court were to
find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an
action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our
business, financial condition and results of operations.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2.
PROPERTIES
Our corporate headquarters are located in San Carlos, California. We lease office facilities under non-cancelable
operating lease agreements. We currently occupy approximately 136,000 square feet of laboratory and office space at 201
69
Industrial Road in San Carlos, California pursuant to a lease that we directly entered into with our landlord in October 2016.
This lease covers two office spaces (the “First Space” and the “Second Space”). The First Space covers approximately
88,000 square feet at an average base rent of $331,249 per month for the year 2019. The Second Space covers
approximately 48,000 square feet at an average base rent of $191,850 per month. The lease term is approximately 84
months and expires in October 2023.
We entered into a sublease agreement in June 2019 with a third party to sublease 25,879 square feet of space
located on the third floor of the San Carlos, California building while maintaining its primary obligation as the intermediate
lessor. The term of this lease is approximately 48 months commencing in October 2019 and expiring in September 2023.
In Tukwila, Washington, we lease a facility initially to provide storage of our cord blood tissue units. The facility
covers approximately 10,000 square feet, with a lease term of 62 months beginning in June 2018 and expiring in July 2023.
In the third quarter of 2019, we sold the Evercord business and the facility was marketed the premise for sublease.
Our subsidiary leases laboratory and office space in Austin, Texas, comprising approximately 94,000 square feet
pursuant to a lease expiring in November 2026.
We may expand our facilities capacity as our employee base and laboratory processing needs grow. We believe
that we will be able to obtain additional space on commercially reasonable terms.
ITEM 3.
LEGAL PROCEEDINGS
From time to time, we are involved in legal proceedings. The results of such legal proceedings and claims
cannot be predicted with certainty, and regardless of the outcome, legal proceedings could have an adverse impact on us
because of defense and settlement costs, diversion of resources and other factors.
For information regarding certain current legal proceedings, see “Note 8—Commitments and Contingencies—
Legal Proceedings” in the Notes to Consolidated Financial Statements, which is incorporated herein by reference.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
70
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Price of Our Common Stock
Our common stock is listed on the Nasdaq Global Select Market under the symbol “NTRA”.
Holders
As of December 31, 2019, we had 20 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.
Dividends
No cash dividends have ever been paid or declared on our common stock. We currently intend to retain all future
earnings, if any, for use in our business and do not anticipate paying any cash dividends on our common stock in the
foreseeable future. Any future determination to declare cash dividends will be made at the discretion of our board of
directors, subject to applicable laws, and will depend on our financial condition, results of operations, capital requirements,
general business conditions and other factors our board of directors may deem relevant. Our credit agreement with
OrbiMed Royalty Opportunities II, LP, or OrbiMed, restricts our ability to pay cash dividends on our common stock, and
we may also enter into credit agreements or other borrowing arrangements in the future that may further restrict our ability
to declare or pay cash dividends on our common stock.
71
Performance Graph
This performance graph shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or
incorporated by reference into any of our other filings under the Exchange Act or the Securities Act except to the extent
we specifically incorporate it by reference into such filing. The following graph compares the cumulative total stockholder
return on our common stock between our initial public offering on July 2, 2015 and December 31, 2019 with the
cumulative total return of (i) the NASDAQ Biotechnology Index and (ii) the NASDAQ Composite Index over the same
period. The chart assumes $100 was invested at the close of market on July 2, 2015, and assumes the reinvestment of any
dividends. The stock price performance on the following graph is not necessarily indicative of future stock price
performance.
CUMULATIVE TOTAL RETURN COMPARISON
Assumes Initial Investment of $100
From July 2, 2015 to December 31, 2019
$200
$180
$160
$140
$120
$100
$80
$60
$40
$20
s
r
a
l
l
o
D
S
U
$-
7/2/2015
12/31/2015
12/30/2016
12/29/2017
12/31/2018
12/30/2019
Natera, Inc.
NASDAQ Biotechnology Index
NASDAQ Composite Index
Trade Date
Natera, Inc.
Nasdaq
Biotechnology
Nasdaq
Composite
Base period 7/2/2015 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12/31/2015 . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12/31/2016 . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12/31/2017 . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12/31/2018 . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12/31/2019 . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
$
$
$
$
100.00
47.49
51.50
39.53
61.39
147.45
$
$
$
$
$
$
100.00
91.34
71.53
86.60
78.52
97.34
$
$
$
$
$
$
100.00
99.96
107.46
137.81
132.46
178.59
Recent Sales of Unregistered Securities
None.
Purchases of Equity Securities by the Issuer and Affiliated Parties
None.
72
ITEM 6.
SELECTED FINANCIAL DATA
The following table presents our selected historical consolidated financial data. The consolidated statements of
operations data for the three fiscal years ended December 31, 2019, 2018 and 2017 and the consolidated balance sheet data
as of December 31, 2019 and 2018 are derived from our audited consolidated financial statements included elsewhere in
this annual report on Form 10-K.
The consolidated statements of operations data for the fiscal years ended December 31, 2016 and 2015, and the
balance sheet data as of December 31, 2017, 2016 and 2015 are derived from audited financial statements that are not
included in this annual report on Form 10-K.
The selected historical consolidated balance sheet and operating data presented below should be read in
conjunction with the consolidated financial statements and the notes to such statements and “Management's Discussion
and Analysis of Financial Condition and Results of Operations” included elsewhere in this annual report on Form 10-K.
Historical results are not necessarily indicative of the results to be expected in the future.
(in thousands, except per share data)
2019
Year ended December 31,
2017
2018
2016
2015
(1)
Selected Statement of Operations Data:
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 302,328 $ 257,654 $
212,512 $ 190,355
Total cost and expenses . . . . . . . . . . . . . . . . . . . . . .
418,615
250,193
313,562
Interest expense and other (expense) income, net . .
(6,541)
(10,437)
865
—
(1,999)
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . . .
(142)
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (124,827) $ (128,154) $ (137,628) $ (100,327) $ (70,275)
(2.68)
Net loss per share, basic . . . . . . . . . . . . . . . . . . . . . . $
(2.68)
Net loss per share, diluted . . . . . . . . . . . . . . . . . . . . . $
209,625 $
344,966
(1,833)
(454)
372,282
(13,205)
(321)
(1.79) $
(1.79) $
(2.22) $
(2.22) $
(2.58) $
(2.59) $
(1.95) $
(1.95) $
(in thousands)
2019
2018
As of December 31,
2017
2016
2015
(1)
Selected Balance Sheet Data:
Cash, cash equivalents and restricted cash . . . . . . . $
Short-term investments . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Convertible preferred stock . . . . . . . . . . . . . . . . . . .
Total stockholders' equity (deficit) . . . . . . . . . . . . . .
61,981 $
379,065
12,394
23,283
582,656
123,779
303,945
—
278,711
51,004 $
107,461
13,633
24,336
268,171
123,510
236,009
13,021 $
106,247
8,998
29,667
214,613
123,177
189,196
—
—
32,162
25,417
16,690 $ 30,531
130,860 201,586
8,093
6,414
32,289
12,710
247,781 265,240
42,090
49,624
80,475
104,204
—
—
143,577 184,765
(1)
effective January 1, 2018, using the full retrospective method, which restated fiscal years 2017 and 2016.
Does not reflect the impact of the adoption of ASC Topic 606, Revenue from Contracts with Customers,
73
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction
with our consolidated financial statements and related notes included in Part II, Item 8 of this report. This discussion
contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from
those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those
identified below and those discussed in “Risk Factors” included elsewhere in this report.
Overview
We are a growing diagnostics company with proprietary molecular and bioinformatics technology that we are
deploying to change the management of genetic disease worldwide. Our goal is to develop and commercialize non- or
minimally-invasive tests to evaluate risk for a wide range of genetic conditions, such as Down syndrome, the results of
which can enable early detection, diagnosis and treatment. Our technology has been proven clinically and commercially
in the prenatal testing space. We have begun translating this success into the liquid biopsy space, where we are leveraging
our core expertise to develop products for oncology diagnostic applications, and are also working to develop a transplant
rejection test. We seek to enable even wider adoption of our technology through our global cloud-based distribution model.
In addition to our direct sales force in the United States, we have a global network of over 100 laboratory and distribution
partners, including many of the largest international laboratories.
Since 2009, we have launched a comprehensive suite of thirteen products in reproductive health and prenatal
testing – 13 molecular diagnostic tests and a newborn stem cell banking offering to complement our prenatal testing
portfolio – as well as our offerings in oncology and transplant rejection, and our Constellation cloud-based platform. We
generate a majority of our revenues from the sale of Panorama, our non-invasive prenatal test, or NIPT, which we
commercially launched in March 2013. We launched our microdeletions panel for Panorama in 2014 and our twins, egg
donor, and surrogate screening capabilities in 2017. We also generate a significant portion of our revenues from the sale
of our Horizon Carrier Screening (HCS) test, which we launched in 2012. We launched our Constellation software platform,
which forms the core of our cloud-based distribution model, in May 2015. In August 2017, we launched Signatera, a
circulating tumor DNA technology that analyzes and tracks mutations specific to an individual’s tumor, for research use
only by oncology researchers and biopharmaceutical companies. Signatera was commercially launched in May 2019 for
clinical use as an LDT in our own CLIA-certified and CAP-accredited laboratory. We received a final Medicare local
coverage determination, or LCD, for Prospera in December 2019, covering all kidney transplant recipients, including those
with multiple kidney transplants, and are working towards a full-scale commercial launch of Prospera in 2020. Our
revenues were $302.3 million for the year ended December 31, 2019, and $257.7 million and $209.6 million for the years
ended December 31, 2018 and 2017, respectively.
We were formed in 2003 under our former name, Gene Security Network. From 2006 through 2013, the National
Institutes of Health awarded us cumulative grants of $5.7 million to conduct various research projects including non-
invasive aneuploidy screening on circulating fetal cells for prenatal diagnosis. An initial period of research and
development was followed by the commercialization of Spectrum Preimplantation Genetic Screening in 2009 and
Spectrum Preimplantation Genetic Diagnosis in 2010; Anora Products of Conception (POC) in 2010; our non-invasive
prenatal paternity test in 2011; Horizon Carrier Screening in 2012; Panorama NIPT in 2013; our microdeletions panel for
Panorama in 2014; Constellation in 2015; Vistara, Signatera (RUO) and Panorama for twin pregnancies in 2017; and the
CLIA version of Signatera in 2019.
In the year ended December 31, 2019, we processed most of our tests in our laboratory certified under the Clinical
Laboratory Improvement Amendments of 1988, or CLIA, in San Carlos, California. A portion of our HCS and Vistara
testing is performed by third-party laboratories. Our customers include independent laboratories, national and regional
reference laboratories, medical centers and physician practices for our screening tests; and research laboratories and
pharmaceutical companies for our Signatera technology. We market and sell our prenatal screening tests both through our
direct sales force and through our laboratory distribution partners. We bill clinics, laboratory distribution partners, patients
and insurance payers for the tests we perform. In cases where we bill laboratory distribution partners, our partners in turn
bill clinics, patients and insurers. The majority of our revenue comes from insurers. Insurers with which we have in-
74
network contracts reimburse for NIPT procedures based on positive coverage determinations, which means that the insurer
has determined that NIPT in general is medically necessary for this category of patient. In the United States, the majority
of insurance providers provide positive NIPT coverage. As of December 31, 2019, we have in-network contracts with
insurance providers that account for approximately 212 million covered lives in the United States. A "covered life" means
a subscriber, or a dependent of a subscriber, who is insured under an insurance policy with the insurance carrier identified.
The number of covered lives represented by insurers that have positive coverage determinations or with which we or our
laboratory distribution partners have a contract provides a measure of our access to the healthcare market. Although our
target market for NIPT is a much smaller subset of the total number of covered lives because it excludes subscribers for
whom our NIPT would not be performed, such as men, children and post-menopausal women, we believe the number of
U.S. covered lives for whom we have access under contract represents an important indicator of our access to the total
available market for our products. Insurers also reimburse for our products through out-of-network claims submission
processes where we do not have a contract with that insurer.
The principal focus of our commercial operations currently is to distribute molecular diagnostic tests through our
direct sales force, our laboratory distribution partners, and our Constellation licensees under our cloud-based distribution
model. The number of tests that we accession is a key indicator that we use to assess our business. A test is accessioned
when we receive the test at our laboratory, the relevant information about the test is entered into our computer system and
the test sample is routed into the appropriate sample flow. This number is a subset of the number of tests that we process,
which includes tests distributed through our Constellation licensees. The number of tests that we process is a key metric
as it tracks overall volume growth, particularly as our laboratory partners may transition from sending samples to our
laboratory to our cloud-based distribution model. During the year ended December 31, 2019, we processed approximately
804,300 tests, comprised of approximately 753,800 tests accessioned in our laboratory, compared to approximately
668,600 tests processed during the year ended December 31, 2018, comprised of approximately 625,900 tests accessioned
in our laboratory; and approximately 515,200 tests processed during the year ended December 31, 2017, comprised of
approximately 486,000 tests accessioned in our laboratory. This increase in volume represents continuous commercial
growth of Panorama and HCS, both as tests performed in our laboratory as well as through our Constellation software
platform.
Prior to 2016, we experienced rapid growth in our U.S.-based internal sales force as part of our effort to increase
the number of tests distributed through our direct sales force, because we generate a higher gross margin when we sell
testing services directly. The percent of our revenues attributable to our U.S. direct sales force were 80%, 83% and 84%
for the years ended December 31, 2019, 2018, and 2017, respectively. The percent of our revenues attributable to U.S.
laboratory partners for the year ended December 31, 2019 was 6%, which was up from 5% when compared to the years
ended December 31, 2018 and 2017. Our ability to increase our revenues and gross profit will depend on our ability to
further penetrate the U.S. market with our direct sales force. The percent of our revenues attributable to international
laboratory partners and other international sales for the years ended December 31, 2019 was 14%, up from 12% for the
year ended December 31, 2018 and 11% for the year ended December 31, 2017.
In addition to distributing molecular diagnostic tests to be performed at our laboratory, either directly or through
our laboratory partners, we also establish licensing arrangements with laboratories under our cloud-based distribution
model, whereby our laboratory licensees run the molecular workflows themselves and then access bioinformatics
algorithms through our cloud-based Constellation software. This cloud-based distribution model results in lower revenues
and gross profit per test than in cases where we process a test ourselves; however, because we don’t incur the costs of
processing the tests ourselves, our costs per test under this model are also lower. In February 2014, we entered into a
licensing and service arrangement with a prenatal paternity licensee, to enable the development of a non-invasive prenatal
paternity test based on our proprietary technology. The prenatal paternity licensee commercializes this test, and we receive
royalty revenues from them. Starting the fourth quarter of 2015, we began entering into other licensing arrangements. For
the years ended December 31, 2019, 2018 and 2017, we have recognized revenues of $2.6 million, $2.4 million and $2.4
million from the prenatal paternity licensee arrangement, respectively. Regarding revenues recognized from our
Constellation licensing arrangements, we have recognized $2.5 million, $2.4 million and $1.8 million during the years
ended December 31, 2019, 2018 and 2017, respectively.
In April 2017, we launched Evercord, a private cord blood and cord tissue processing and storage service. Our
U.S. direct sales force sold Evercord to the same OB/GYNs who prescribe and ordered Panorama and HCS tests, and our
75
own inside sales force offered this product to our existing and past patients who have used our Panorama and HCS tests.
Upon the launch of Evercord, we also entered into an agreement with a cord blood bank to perform processing and testing
of cord blood and cord tissue units and to store those units at its facility. Our Evercord service included the provision of a
collection kit and the collection, processing and storage of newborn cord blood and cord tissue units. Evercord customers
paid a one-time fee for the processing of the units. Customers had the option to store their units under an annual plan, or
to pre-pay for 18 years or the duration of their lifetime (for which we assume a useful life of 78 years); they also had the
option to pay for storage in full at the time of collection of the unit, or over a period of six, 12, or 18 months. In
September 2019, we sold the Evercord business for total estimated consideration of $15.4 million and recognized a gain
of $14.4 million in our consolidated statement of operations.
In May 2017, we launched Vistara, which is an NIPT that screens for single-gene disorders and offered as a
complement to Panorama. Upon the launch of Vistara, we entered into an agreement with a laboratory partner to
collaborate in improving test performance and to launch commercially. In August 2017, we launched Signatera, a
circulating tumor DNA technology that analyzes and tracks mutations specific to an individual’s tumor, for research use
only by oncology researchers and biopharmaceutical companies. Signatera was commercially launched in May 2019 for
clinical use as an LDT in our own CLIA-certified and CAP-accredited laboratory. In October 2017, we expanded our
Panorama test to now screen twin pregnancies for zygosity and chromosomal abnormalities. In August 2019, we received
a Medicare positive draft local coverage determination for certain forms of colorectal cancer. We received a final Medicare
local coverage determination, or LCD, for Prospera in December 2019, covering all kidney transplant recipients, including
those with multiple kidney transplants, and are working towards a full-scale commercial launch of Prospera in 2020.
For the year ended December 31, 2019, total revenues were $302.3 million, compared to $257.7 million and
$209.6 million, respectively, in the years ended December 31, 2018 and 2017. Revenues generated from our genetic testing
accounted for $269.9 million or 89% of total revenues for the year ended December 31, 2019; $240.4 million or 93% of
total revenues for the year ended December 31, 2018; and $203.8 million or 97% of total revenues for the year ended
December 31, 2017. For the years ended December 31, 2019, 2018 and 2017, there were no customers exceeding 10% of
the total revenues on an individual basis. Revenues from customers outside the United States were $41.5 million,
representing 14% of total revenues for the year ended December 31, 2019. For the years ended December 31, 2018 and
2017, revenues from customers outside the United States were $31.7 million and $24.1 million, representing
approximately 12% and 11%, respectively, of total revenues. Most of our revenues have been denominated in U.S. dollars,
but we began to generate revenue in foreign currency in 2015, primarily denominated in Euros and Singapore Dollars.
Our net losses for the years ended December 31, 2019, 2018 and 2017 were, respectively, $124.8 million, $128.2
million and $137.6 million. This included non-cash stock compensation expense of $28.6 million, $14.2 million and
$11.4 million for the years ended December 31, 2019, 2018 and 2017, respectively. As of December 31, 2019, we had an
accumulated deficit of $699.2 million.
Components of the Results of Operations
The section of this Management’s Discussion and Analysis generally discusses year-to-year comparisons
between 2019 and 2018. Discussions of year-to-year comparisons between 2018 and 2017 that are not included in this
Annual Report on Form 10-K can be found in “Management’s Discussion and Analysis” in Part II Item 7 of our Annual
Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the SEC on March 15, 2019.
Revenues
We generate revenues from the sale of our genetic tests, primarily from the sale of our Panorama and HCS tests.
Our two primary distribution channels are our direct sales force and our laboratory partners. In cases where we promote
our tests through our direct sales force, we generally bill directly to a patient, clinic or insurance carrier, or a combination
of the insurance carrier and patient for the fees.
In cases where we sell our tests through our laboratory partners, the majority of our laboratory partners bill the
patient, clinic or insurance carrier for the performance of our tests, and we are entitled to either a fixed price per test or a
percentage of their collections.
76
Starting the fourth quarter of 2015, we began recognizing licensing revenues through the licensing and the
provisioning of services to support the use of our proprietary technology by our cloud-based distribution model licensees.
From the second quarter of 2017 to the third quarter of 2019, we recognized revenues from our Evercord offering.
Sales of Panorama and HCS tests are recorded as product revenues. Revenues recognized from tests processed
through our Constellation software platform, Evercord and Signatera (CLIA) revenues, and revenue recognized from the
Qiagen LLC (“Qiagen”), BGI Genomics (“BGI”), and Foundation Medicine, Inc. (“FMI”) agreements (collectively the
“strategic partnership agreements”), and Signatera (RUO) are reported in licensing and other revenues. As of December 31,
2019, we have commercially launched 14 licensing and service arrangements with laboratories under our cloud-based
distribution model from which we recognized revenue from in 2019.
Prior to 2018, we recognized the majority of our revenues from contracts with insurance carriers upon receipt of
cash due to limited historical experience and uncertainty in determining the amount of revenue and timing of collections.
Effective January 1, 2018, we adopted the new revenue guidance, Accounting Standards Codification Topic 606, Revenue
from Contracts with Customers (“ASC 606”), using the full retrospective approach. In accordance with ASC 606, the total
consideration we expect to collect from insurance carriers, clinics, and patients in exchange for the goods and services
provided is accrued in the period in which our tests are reported to customers. Due to potential future changes in insurance
coverage policies, contractual rates, and other trends in the reimbursement of our tests, our collections may fluctuate
significantly over time.
Our ability to increase our revenues will depend on our ability to further penetrate the domestic and international
markets and, in particular generate sales through our direct sales force, develop and commercialize additional tests, obtain
reimbursement from additional third-party payers and increase our reimbursement rate for tests performed. In particular,
our financial performance depends on reimbursement for Panorama in the average risk population and for microdeletions.
The use of Panorama in the average risk population is not yet broadly reimbursed, although many third-party payers have
begun to reimburse for this. Many third-party payers do not currently reimburse for microdeletions screening, as further
discussed in the risk factor entitled “Reimbursement and Regulatory Risks Related to Our Business—If we are unable to
expand or maintain third-party payer coverage and reimbursement for Panorama and our other tests, or if we are required
to refund any reimbursements already received, our revenues and results of operations would be adversely affected,” in
part because there is currently limited published data on the performance of microdeletions screening tests. A new current
procedure terminology, or CPT, code for microdeletions went into effect beginning January 1, 2017. We have experienced
low average reimbursement rates thus far for microdeletions testing under this new code, and we expect that this new code
will cause, at least in the near term, our microdeletions reimbursement to remain low, due to third-party payers declining
to reimburse and through reduced reimbursement under the new code. This has had, and we expect it will continue to have,
an adverse impact on our revenues. In addition, a new CPT code for expanded carrier screening went into effect beginning
January 1, 2019, and has had, and may continue to have an adverse effect on our reimbursement rates for our broader
Horizon carrier screening panel, for which we previously primarily received reimbursement on a per-condition basis, as
those tests may be reimbursed as a combined single panel instead of as multiple individual tests. Because our revenues
from Horizon continue to represent an increasing proportion of our overall revenues, a decline in our reimbursement rates
for, and therefore our average selling price of, Horizon, could result in a decline in our overall revenue.
Our financial performance is also impacted by having increased our in in-network coverage with third-party
payers, which we believe is crucial to our growth and long-term success. However, because the negotiated fees under our
contracts with third-party payers are typically lower than the list price of our tests, as we enter into additional in-network
contracts with insurance providers, our average reimbursement per test decreases. While we expect the reduction in
average reimbursement per test from in-network pricing to reduce our revenues and gross margins in the near term, in-
network pricing is more predictable than out-of-network pricing, and we intend to continue to mitigate the impact by
driving more business from our most profitable accounts. In addition, our strategy to offer our tests to laboratory licensees
via our Constellation cloud-based software platform may also cause our revenues to decrease because we do not process
the tests and perform the molecular biology analysis in our own laboratory under this model, and therefore are not able to
charge as high an amount, and as a result realize lower revenues per test than when we perform the entire test ourselves.
However, cost of licensing and other revenues for the Constellation software platform are relatively low, and therefore, its
associated gross margin is higher.
77
Cost of Product Revenues
The components of our cost of product revenues are materials and service costs, personnel costs, including stock-
based compensation expense, equipment and infrastructure expenses associated with testing samples, electronic medical
record, order and delivery systems, shipping charges to transport samples, costs incurred from outsourcing our tests to
third parties, and allocated overhead such as rent, information technology costs, equipment depreciation and utilities. Costs
associated with performing tests are recorded when the test is accessioned. We expect cost of product revenues in absolute
dollars to increase as the number of tests we perform increases.
However, having rapidly achieved scale, we have increased our focus on more efficient use of labor, automation,
and DNA sequencing. For example, we updated the molecular and bioinformatics process for Panorama to further reduce
the sequencing reagents, test steps and associated labor costs required to obtain a test result, while increasing the accuracy
of the test to allow it to run with lower fetal fraction input. These improvements also reduced the frequency of the need to
require blood redraws from the patient.
Cost of Licensing and Other Revenues
The components of cost of licensing and other revenues are material costs associated with IVD kits sold
to constellation clients, engineering costs incurred by the research and development team to improve and maintain the
Constellation software platform, amortization of Constellation software development costs, development and support
services relating to our strategic partnership agreements, and costs associated with specimens and Whole Exome
Sequencing (“WES”) relating to our Signatera offering. Costs also include labor and other costs of development activities,
collection kits consumed during the processing of cord blood samples, processing service and storage of the cord blood
samples, and freight charged to transport the samples to the storage facility. Through the third quarter of 2019, cost of
licensing and other revenues also includes costs associated with Evercord (see Note 13, Disposal of Business).
We currently have 14 revenue generating licensing and service agreements with laboratories and continue to have
active discussions with many other potential licensees under our Constellation distribution model. We consider our cost
of licensing and other revenues for the Constellation software platform to be relatively low, and therefore we expect its
associated gross margin to be higher.
Research and Development
Research and development expenses include costs incurred to develop our technology, collect clinical samples
and conduct clinical studies to develop and support our products. These costs consist of personnel costs, including stock-
based compensation expense; prototype materials; laboratory supplies; consulting costs; regulatory costs; electronic
medical record set up costs; and costs associated with setting up and conducting clinical studies at domestic and
international sites and allocated overhead, including rent, information technology, equipment depreciation and utilities.
We expense all research and development costs in the periods in which they are incurred. We expect our research and
development expenses to increase in absolute dollars as we continue to invest in research and development activities
related to developing enhanced and new products.
Selling, General and Administrative
Selling, general and administrative expenses include executive, selling and marketing, legal, finance and
accounting, human resources, billing and client services. These expenses consist of personnel costs, including stock-based
compensation expense; direct marketing expenses; audit and legal expenses; consulting costs; training and medical
education activities; payer outreach programs and allocated overhead, including rent, information technology, equipment
depreciation, and utilities.
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Gain on Disposal of Business
In September 2019, we sold our Evercord business that provided cord tissue processing and storage services for
total estimated consideration of $15.4 million, including $9.7 million in cash, $1.0 million of cash deposited in a third-
party escrow account recorded in short-term other receivables, and $4.7 million of additional consideration. We recognized
a gain of $14.4 million on the sale, which was included in loss from operations in the consolidated statements of operations
and comprehensive loss.
Interest Expense
Interest expense is attributable to borrowing under our Credit Line and 2017 Term Loan, as well as the
amortization of debt discount associated with the 2017 Term Loan.
Interest Income and Other (Expense) Income, Net
Interest income and other (expense) income, net is comprised of interest earned on our cash, realized gains and
losses on investments, foreign currency remeasurement gains and losses, changes in the fair value of our warrants, and
finance charges related to the unused borrowing capacity of our 2017 Term Loan.
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations is based on our
financial statements, which have been prepared in accordance with generally accepted accounting principles in the United
States, or U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial
statements, as well as the reported revenue generated and expenses incurred during the reporting periods. 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.
Our significant accounting policies are described in Note 2 to our audited financial statements included in Item 8
in this Annual Report. Some of these accounting policies require us to make difficult and subjective judgments, often as a
result of the need to make estimates of matters that are inherently uncertain. We consider the following critical accounting
policies to reflect the more significant estimates and assumptions used in the preparation of our financial statements.
On January 1, 2019, we adopted the new accounting requirements under ASC 842 using the modified
retrospective approach, which now requires most leases to be recognized as right-of-use assets and corresponding lease
liabilities in the balance sheet. Upon adoption, we had three existing leases that were classified as operating leases, and
the present value of their minimum future lease payments was determined by discounting the cash flows using the
incremental borrowing rate with a term approximating the remaining term of each lease. We elected the optional
transitional guidance under ASC 842 that allowed the initial recognition of the operating right-of-use assets and the
corresponding lease liabilities as of January 1, 2019 instead of the earliest period presented.
Effective January 1, 2019, we also transitioned to the new accounting requirements under Accounting Standards
Update (“ASU”) ASU 2018-07 for non-employee stock-based awards using the modified retrospective approach. The new
guidance changes the fair value measurement requirements for our non-employee stock-based awards from remeasuring
them at the end of each reporting period to a one-time measurement as of the grant date using the Black-Scholes option
pricing model, while the method of recognizing the stock-based compensation remains unchanged. Starting January 1,
2019, we have elected to use expected term rather than remaining contractual term when determining the fair value of the
non-employee awards, as well as the option to recognize actual forfeitures as they occur. Upon adoption, we recorded a
$0.2 million cumulative-effect adjustment to the balance of accumulated deficit in the balance sheet.
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Revenue Recognition
Effective January 1, 2018, we adopted the new revenue recognition standard, ASC 606, using the full
retrospective approach, which required us to record a cumulative-effect adjustment to accumulated deficit as of the earliest
period presented in the consolidated financial statements.
We recognize revenues when, or as, performance obligations in the contracts are satisfied, in the amount reflecting
the expected consideration to be received from the goods or services transferred to the customers.
Product Revenues
Product revenues are derived from contracts with insurance carriers, laboratory partners and patients in
connection with sales of prenatal genetic tests. The majority of our revenues is derived from Panorama NIPT, HCS, and
to a lesser extent, other genetic tests. We enter into contracts with insurance carriers with primarily payment terms related
to tests provided to the patients who have health insurance coverage. Insurance carriers are considered third-party payers
on behalf of the patients, and the patients are considered the customers who receive genetic test services. Tests may be
billed to insurance carriers, patients, or a combination of insurance carriers and patients. Further, we sell tests to a number
of domestic and international laboratory partners and identify the laboratory partners as customers provided that there is a
test services agreement between us and them.
A performance obligation represents a promise in a contract to transfer a distinct good or service to a customer,
which represents a unit of accounting in accordance with ASC 606. A portion of the consideration should be allocated to
each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. We
evaluate our contracts with insurance carriers, laboratory partners and patients and identify a single performance obligation
in those contracts, which is the delivery of the test results.
The total consideration which we expect to collect in exchange for our products is an estimate and may be fixed
or variable. Consideration includes reimbursement from both patients and insurance carriers, adjusted for variable
consideration related to disallowed cases, discounts, refunds and doubtful accounts, and is estimated using the expected
value approach. For insurance carriers with similar reimbursement characteristics, we use a portfolio of relevant historical
data to estimate variable consideration and total collections for our products. We constrain the estimated variable
consideration when we assess it is probable that a significant reversal in the amount of cumulative revenue recognized
may occur in future periods. The consideration expected from laboratory partners usually includes a fixed amount, but it
can be variable depending on the volume of tests performed, and we determine the variable consideration using the
expected value approach. For insurance carriers, laboratory partners and patients, we allocate the total consideration to a
single performance obligation, which is the delivery of the test results to the customers.
When assessing the total consideration for insurance carriers and patients, a certain percentage of revenues is
further constrained for estimated refunds.
We generally bill an insurance carrier, a laboratory partner or a patient upon delivery of test results. We also bill
patients directly for out-of-pocket costs involving co-pays and deductibles that they are responsible for. Tests billed to
insurance carriers and directly to patients usually take an average of nine to twelve months to collect the payments, and
for tests billed to laboratory distribution partners, the average collection cycle takes approximately two to three months.
At times, we may or may not get reimbursed for the full amount billed. Further, we may not get reimbursed at all for tests
performed if such tests are not covered under the insurance carrier’s reimbursement policies or we are not a qualified
provider to the insurance carrier, or if the tests were not previously authorized.
Product revenue is recognized in an amount that equals the total consideration (as described above) at a point in
time when the test results are delivered. We reserve certain amounts in other accrued liabilities on the balance sheet in
anticipation of requests for refunds of payments previously made by insurance carriers, which are accounted for as
reductions in product revenues in the statement of operations and comprehensive loss. During the years ended December
80
31, 2019 and 2018, $2.4 million and $3.3 million were released from amounts previously held in reserves in other accrued
liabilities and recognized as product revenue.
Licensing and Other Revenues
We recognize licensing revenues from our Constellation cloud-based distribution model, pursuant to which we
grant licenses to laboratories to access our proprietary bioinformatics algorithms through our cloud-based software to
analyze the results of molecular workflows that such licensees perform in their laboratories. In addition, the royalties we
receive from our arrangement with a prenatal paternity licensee are recognized Constellation revenues.
We also recognize revenues from our Signatera (RUO) offering, which is for research use only to cancer
researchers and biopharmaceutical companies. We enter into agreements with pharmaceutical companies to utilize the our
Signatera tests typically to study new cancer treatments or to validate the outcomes of clinical trials for which the
pharmaceutical companies are identified as customers.
We also recognize revenues from our strategic partnership agreements (i.e., Qiagen, BGI, and FMI). The
performance obligations are unique in each agreement and would typically require the license of intellectual property,
development services, support services, and future test work. We recognized $16.4 million of revenues from strategic
partnership agreements in the year ended December 31, 2019 (for details see Note 3, Revenue Recognition).
In addition, we recognize revenues from IVD Kits, and the Evercord offering for the processing and storage of
newborn cord blood and cord tissue units through the third quarter of 2019.
Income Taxes
We account for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”), which requires
recognition of deferred tax assets and liabilities for the expected tax consequences of our future financial and operating
activities. Under ASC 740, we determine deferred tax assets and liabilities based on the temporary difference between the
financial statement and tax bases of assets and liabilities using the tax rates in effect for the year in which we expect such
differences to reverse. If we determine that it is more likely than not that we will not generate sufficient taxable income
to realize the value of some or all of our deferred tax assets (net of our deferred tax liabilities), we establish a valuation
allowance offsetting the amount we do not expect to realize. We perform this analysis each reporting period and reduce
our measurement of deferred taxes, if the likelihood we will realize them becomes uncertain.
We also account for uncertain tax positions in accordance with ASC 740, which requires us to adjust our financial
statements to reflect only those tax positions that are more-likely-than-not to be sustained upon review by federal or state
examiners. We may recognize a tax benefit only if it is more likely than not the tax position will be sustained on
examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the
financial statements from such positions are then measured based on the largest benefit that has a greater than 50%
likelihood of being realized upon settlement. We established a full valuation allowance against its net deferred tax assets
in 2019 and 2018 due to the uncertainty surrounding realization of these assets (for details, please refer to Note 14, Income
Taxes). In addition, our policy is to report interest and penalties related to unrecognized tax benefits as income tax
expenses.
81
Stock-Based Compensation
We have included stock-based compensation as part of our cost of revenues and our operating expenses in our
statements of operations as follows:
2019
Year ended December 31,
2018
2017
Employee Non-Employee Total
Employee Non-Employee Total
Employee Non-Employee Total
(in thousands)
Cost of
revenues . . . . . . . $
905 $
32
937 $
564 $
5 $
569 $
544 $
— $
544
Research and
development . . . .
5,354
—
5,354
4,043
—
4,043
3,214
—
3,214
Selling, general and
administrative . . . 21,730
Total . . . . . . . . . . . $ 27,989 $
9,474
603 22,333
635 $ 28,624 $ 14,081 $
112
117 $ 14,198 $ 11,402 $
9,586
7,644
7,644
—
— $ 11,402
Stock-based compensation related to stock options granted to our employees and non-employees is measured at
the grant date based on the fair value of the award, which is determined by the Black-Scholes option-pricing model and
the Monte Carlo simulation model. The fair value is recognized as expense over the requisite service period, which is
generally the vesting period of the respective awards. No compensation cost is recognized on stock options for employees
and non-employees who do not render the requisite service and therefore forfeit their rights to the stock options. The
measurement of stock-based compensation is subject to periodic adjustments as the underlying equity instruments vest,
and the resulting change in value, if any, is recognized in our statements of operations and comprehensive loss during the
period that the related services are rendered.
Impairment of Long-lived Assets
We evaluate our long-lived assets for indicators of possible impairment when events or changes in circumstances
indicate the carrying amount of an asset may not be recoverable. We then compare the carrying amounts of the assets with
the future net undiscounted cash flows expected to be generated by such asset. Should an impairment exist, the impairment
loss would be measured based on the excess carrying value of the asset over the asset’s fair value determined using
discounted estimates of future cash flows.
For the year ended December 31, 2019, an asset impairment charge of $1.7 million was recorded in general and
administrative expenses in the statements of operations and comprehensive loss. This charge is comprised of $1.2 million
from the impairment of leasehold improvements, $0.1 million from the impairment of capitalized software held for internal
use, and $0.4 million from the right-of-use asset related to the disposal of business. The right-of-use asset and the leasehold
improvements relate to the storage facility located in Tukwila, Washington, and both assets were evaluated for impairment
as a single asset group. Subsequent to the sale of Evercord, we recognized an impairment charge for the leasehold
improvements that was previously capitalized for the storage facility and wrote down the right-of-use asset to its fair value
as of the sale date. We have marketed the leased location for subleasing. The impairment charge to capitalized software
relate to an internally developed module that was solely used for the Evercord business and scrapped subsequent to the
sale of Evercord.
For the year ended December 31, 2018, we recorded asset impairment charges totaling $1.5 million in research
and development expenses in the statements of operations and comprehensive loss. This charge was recorded to write off
certain project development costs that were previously capitalized.
82
Results of operations
Comparison of the years ended December 31, 2019, 2018 and 2017
(in thousands)
Revenues:
Year Ended December 31,
2018
2019
2017
Changes
2019 - 2018
Amount
Percent
2018 - 2017
Amount Percent
Product revenues . . . . . . . . . . . . $ 269,881 $ 240,366 $ 203,777 $ 29,515
15,159
32,447
Licensing and other revenues . .
Total revenues . . . . . . . . . . . . . . . . .
44,674
302,328
Cost and expenses:
5,848
209,625
17,288
257,654
12.3 % $ 36,589
11,440
87.7
48,029
17.3
18.0 %
195.6
22.9
Cost of product revenues . . . . . .
Cost of licensing and other
revenues . . . . . . . . . . . . . . . . . .
Research and development . . . .
Selling, general and
162,604
158,081
135,508
4,523
2.9
22,573
16.7
12,866
51,357
7,974
51,355
4,088
50,064
4,892
2
61.3
0.0
3,886
1,291
95.1
2.6
administrative . . . . . . . . . . . . .
Gain on disposal of business . . .
Total cost and expenses . . . .
206,176
(14,388)
418,615
154,872
—
372,282
344,966
Loss from operations . . . . . . . . . . (116,287) (114,628) (135,341)
Interest expense . . . . . . . . . . . . . . . .
(4,213)
Interest and other (expense)
(10,476)
(10,693)
51,304
— (14,388)
46,333
(1,659)
(217)
155,306
33.1
*
12.4
1.4
2.1
(434)
—
27,316
20,713
(6,263)
(0.3)
*
7.9
(15.3)
148.7
income, net . . . . . . . . . . . . . . . . . .
6,881 (252.1)
2,380
(3.9)
5,005
Loss before income taxes . . . . . . . . (122,828) (127,833) (137,174)
Income tax expense . . . . . . . . . . . . .
522.7
(1,678)
(454)
Net loss . . . . . . . . . . . . . . . . . . . . . . $ (124,827) $ (128,154) $ (137,628) $ 3,327
(2,729)
(1,999)
4,152
(321)
(5,109) (214.7)
(6.8)
(29.3)
9,341
133
(2.6)% $ 9,474
(6.9)%
* Not meaningful
Revenues
Total revenues are comprised of product revenues, which are primarily driven by sales of our Panorama and HCS
tests, and licensing and other revenues, which include primarily of revenues from our strategic partnership agreements,
Signatera (RUO) offering, licensing of our Constellation software to our licensees and revenues from the Evercord business.
Total revenues increased by $44.7 million, or 17.3%, when compared to the year ended December 31, 2018.
Product revenues
During the year ended December 31, 2019, product revenues increased $29.5 million, or 12.3%, as a result of
continued revenue growth in genetic test products such as Panorama and HCS. The number of Panorama and HCS tests
accessioned continued to grow during the year ended December 31, 2019 when compared to the same period in the prior
year by approximately 20%, and the resulting growth in revenues was partially offset by continued erosion in collection
trends driven by factors such as prior authorization requirements by insurance carriers for an increasing proportion of our
volumes. A portion of the net increase in Panorama and HCS revenues pertained to cumulative catch-up revenue
adjustments totaling approximately $6.8 million recognized in the current period, due to collections from appeals on claims
in the prior periods.
Licensing and other revenues
Licensing and other revenues increased $15.2 million, or 87.7%, during the year ended December 31, 2019 when
compared to the same period in the prior year primarily due to an increase of $15.7 million from license and development
services revenue from new strategic partnership agreements, $4.2 million increase of revenues from our other offerings
83
such as Evercord and oncology, and offset by a decrease in revenues from the Qiagen agreement by $5.2 million primarily
due to upfront license revenues recognized in the year ended December 31, 2018, while no such revenues were recognized
in the year ended December 31, 2019.
We derive our revenues from tests based on units reported to customers—tests delivered with a result. All reported
units are either accessioned in our laboratory, processed outside of our laboratory, or processed as part of the Evercord
offering. As noted in “—Overview,” the number of tests that we process is a key metric as it tracks overall volume growth.
During the year ended December 31, 2019, total reported units were approximately 763,900, comprising of approximately
718,500 tests reported in our laboratory.
In addition, our ability to market and sell our tests outside of the United States has shown growth as revenues
from customers outside the United States were $41.5 million for the year ended December 31, 2019, compared to $31.7
million for the year ended December 31, 2018.
Cost of product revenues
During the year ended December 31, 2019, cost of product revenues increased $4.5 million, or 2.9%, when
compared to the year ended December 31, 2018 primarily due to $9.5 million of additional costs incurred from increased
volume of tests accessioned such as inventory consumption and materials acquired for Panorama tests and our in-house
HCS automation and $7.2 million increase attributable to labor and overhead allocation driven by resources dedicated to
our HCS automation process and Panorama tests. In addition, overall shipping costs for our products increased by $0.8
million despite a large increase of reported units. This was offset by a decrease of $13.0 million of specimen fees paid to
third parties primarily attributable to the HCS automation workflow.
Cost of licensing and other revenues
Cost of licensing and other revenues increased by $4.9 million, or 61.3%, during the year ended December 31,
2019 compared to the year ended December 31, 2018 primarily due to increased development and support efforts
associated with license and test development services for our strategic partnership agreements, and internal and third-party
provider costs incurred in connection with our oncology product offering that was launched in August 2017. During the
year ended December 31, 2019, costs incurred for one of our strategic partnership agreements entered into in the second
quarter of 2019 was $2.1 million and costs associated with a product offering launched in August 2017 increased by $4.3
million compared to $1.0 million in the same period prior year. The increase was offset by a $2.0 million decrease of cost
associated with Evercord services due to the sale of this business in the third quarter of 2019.
Research and development
Research and development expenses remained flat in the year ended December 31, 2019 compared to the year
ended December 31, 2018. This was primarily the result of a $2.1 million increase in research and development efforts for
the commercialization of our Signatera cancer monitoring offering and our Prospera transplant rejection test due to higher
salary and related expenses and employee benefits from increased headcount, offset by an impairment charge of $1.5
million recognized for writing off the project development costs previously capitalized in the year ended December 31,
2018, while no such impairment charge was incurred in the year ended December 31, 2019. The increase was further offset
by a decrease in overall costs associated with clinical trials of $0.7 million.
Selling, general and administrative
Selling, general and administrative expenses increased by $51.3 million, or 33.1%, in the year ended December 31,
2019 compared to the year ended December 31, 2018. The primary factors causing the increase were a $27.2 million
increase in salaries and related expenses due to increase of $14.5 million resulting from increase in headcount across
various selling, general and administrative departments and an increase of $12.7 million stock-based compensation
expense resulting from performance- and market-based stock options and restricted stock units granted in the year ended
December 31, 2019, changes in the fair value of the stock options and restricted stock units, and annual refreshers.
Furthermore, we incurred an additional $9.2 million in outside services related to legal fees for litigation and patent defense,
84
international consultants, and SOX 404b implementation, $6.6 million in third-party billing, $3.5 million in overhead
allocation, $3.4 million in travel related expenses, $1.2 million in employee recruiting costs, $1.1 million in bad debt
expense, and offset by $0.9 decreases in other expenses.
Gain on disposal of business
Gain on disposal of business was by $14.4 million in the for the year ended December 31, 2019 due to the gain
on sale of Evercord. There was no such gain recorded in the year ended December 31, 2018.
Interest expense
Interest expense increased by $0.2 million, or 2.1%, in the year ended December 31, 2019 compared to the prior
year. The increase was the result of an increase in the average LIBOR for the year ended December 31, 2019 compared to
the same period prior year. The Term Loan and Credit Line both have variable interest rates and subject to the fluctuations
in the LIBOR.
Interest and other (expense) income, net
Interest and other income was $4.2 million for the year ended December 31, 2019, compared to interest and other
expense of $2.7 million in the same period of the prior year, which represented a net increase in expenses of $6.9 million.
This increase in interest income was the result of a higher balance maintained in our investment portfolio resulting in an
increase of $2.3 million of additional interest income and a charge in the second quarter of 2018 from the revaluation of
the warrants to ROS Acquisition Offshore LP (“ROS”) upon exercise of $4.1 million.
Liquidity and Capital Resources
We have incurred net losses each year since our inception. For the years ended December 31, 2019 and 2018 we
had net losses of $124.8 million and $128.2 million, respectively, and we expect to incur additional losses in the future as
we continue to devote a substantial portion of our resources to our research and development and commercialization efforts
of our existing and new products. As of December 31, 2019, we had $62.0 million in cash, cash equivalents and restricted
cash, $379.1 million in marketable securities, $50.1 million of outstanding balance of the Credit Line including accrued
interest, and $73.7 million of net of debt discount of the 2017 Term Loan.
While we have introduced multiple products that are generating revenues, these revenues have not been sufficient
to fund all operations. Accordingly, we have funded the portion of operating costs that exceeds revenues through a
combination of equity issuances and debt and other financings. We expect to develop and commercialize future products
and, consequently, we will need to generate additional revenues to achieve future profitability and may need to raise
additional equity or incur additional debt. If we raise additional funds by issuing equity securities, our stockholders would
experience dilution. Additional debt financing, if available, may involve covenants restricting our operations or our ability
to incur additional debt. Any additional debt financing or additional equity that we raise may contain terms that are not
favorable to us or our stockholders and requires significant debt service payments, which diverts resources from other
activities. Additional financing may not be available at all, or in amounts or on terms acceptable to us. If we are unable to
obtain additional financing, we may be required to delay the development and commercialization of our products and
significantly scale back our business and operations.
On April 23, 2019, we completed an underwritten equity offering to sell 5,263,158 shares of our common stock
at a price to the public of $19 per share. On April 26, 2019, we sold an additional 789,473 shares of our common stock to
the underwriters at the same price upon their exercise of the option to purchase those shares. Before offering expenses of
$0.6 million, we received proceeds of $108.1 million net of underwriting discount.
On October 17, 2019, we completed an underwritten equity offering to sell 5,714,286 shares of our common stock
at a price to the public of $35 per share. On the same day, we sold an additional 857,142 shares of our common stock to
the underwriters at the same price upon their exercise of the option to purchase those shares. Before offering expenses of
$0.4 million, we received proceeds of $216.2 million net of the underwriting discount.
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Based on our current business plan, we believe that our existing cash and marketable securities will be sufficient
to meet our anticipated cash requirements for at least 12 months after February 28, 2020.
Credit Line Agreement
In September 2015, we entered into the Credit Line with UBS providing for a $50.0 million revolving line of
credit which can be drawn in increments at any time. The Credit Line was amended in July 2017 and bears interest at
30-day LIBOR plus 1.10%, and it is secured by a first priority lien and security interest in our money market and
marketable securities held in our managed investment account with UBS. UBS has the right to demand full or partial
payment of the Credit Line obligations and terminate it, in its discretion and without cause, at any time.
2017 Term Loan
In August 2017, we entered into the 2017 Term Loan with OrbiMed, which had a maximum borrowing capacity
of $100.0 million. On the closing date of August 8, 2017, we borrowed $75.0 million, with the remaining $25.0 million
available to borrow at our option at any time through December 31, 2018, subject to standard conditions. The amounts
borrowed under the 2017 Term Loan will primarily be used for general corporate purposes and to fund and support our
business and operations. Interest accrues on the outstanding balance of the loan at a rate equal to the sum of (i) 8.75% plus
(ii) the higher of 1.00% or LIBOR. The 2017 Term Loan has an 84-month term and will mature in August 2024. We are
required to make interest payments on a quarterly basis, with repayment of the full outstanding balance on the maturity
date. Our obligations under the 2017 Term Loan are secured by substantially all of our assets, including our intellectual
property, subject to certain customary exceptions.
On December 31, 2018, we amended certain terms in the 2017 Term Loan with OrbiMed. The amendment
increased the existing unused borrowing capacity from $25.0 million to $50.0 million and extended the expiration date for
the option to draw the unused borrowing capacity to March 31, 2019. If the aggregate principal amount drawn from the
unused borrowing capacity is $50.0 million, the interest rate described above would instead decrease to the sum of (i) 8.25%
plus (ii) the higher of 1.00% or LIBOR. If the amount drawn is less than $50.0 million, the interest rate would remain at
the sum of (i) 8.75% plus (ii) the higher of 1.00% or LIBOR.
In April 2019, we entered into a second amendment of the 2017 Term Loan with OrbiMed to further extend the
expiration date until December 31, 2019 to draw the unused borrowing capacity of $50.0 million. In the second
amendment, the interest rate is equal to the sum of (i) 8.25% plus (ii) the higher of 1.00% or LIBOR, provided we draw
the minimum capacity of $25.0 million. If the amount drawn is less than $25.0 million, the interest rate would remain at
the sum of (i) 8.75% plus (ii) the higher of 1.00% or LIBOR. As a fee in consideration of extending the commitment to
provide this option to draw until December 31, 2019, we issued an additional 25,000 shares of our common stock to
OrbiMed on April 29, 2019. As of December 31, 2019, we did not exercise such option, and the right to draw the unused
borrowing capacity has expired.
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Cash Flows
The following table summarizes our cash flows for the periods indicated:
Year Ended
December 31,
2018
2019
2017
(in thousands)
Cash used in operating activities . . . . . . . . . . . . . . . . . . . . $ (63,444) $ (70,581) $ (97,825)
13,784
Cash (used in) provided by investing activities . . . . . . . .
Cash provided by financing activities . . . . . . . . . . . . . . . .
80,372
Net increase (decrease) in cash, cash equivalents and
(266,353)
340,774
(5,161)
113,725
restricted cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10,977
37,983
(3,669)
Cash, cash equivalents and restricted cash, beginning
of period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16,690
Cash, cash equivalents and restricted cash, end of year . . $ 61,981 $ 51,004 $ 13,021
13,021
51,004
Cash Used in Operating Activities
Cash used in operating activities during the year ended December 31, 2019 was $63.4 million. The net loss of
$124.8 million includes $34.2 million in non-cash benefits resulting from $7.7 million of depreciation and amortization,
$7.7 million of amortization of the operating right-of-use assets on a straight-line basis subsequent to the adoption of ASC
842, $28.6 million of stock-based compensation expense; amortization of debt discount, premium amortization and
discount accretion on investment securities totaling $1.4 million, $0.3 million of inventory excess adjustments, $1.7
million from impairment of assets, and $1.2 million in other non-cash charges. These non-cash charges were offset by
$14.4 million gain on disposal of Evercord. Operating assets had $19.7 million cash outflow resulting from $13.9 million
increases in prepaid and other current assets, $9.1 million increases in other assets, offset by a $2.4 million decrease in
accounts receivable, $0.9 million decrease in inventory. Operating liabilities generated cash inflows of $46.9 million due
to an increase of deferred revenues of $40.9 million primarily driven by prepaid license, royalties and milestone payments
from our strategic partnership agreements, an increase in accrued compensation of $3.4 million, an increase in other long-
term liabilities of $0.3 million, and an increase in other accrued liabilities by $8.6 million, offset by a decrease in accounts
payable of $6.3 million.
Cash used in operating activities during the year ended December 31, 2018 was $70.6 million. The net loss of
$128.2 million includes $30.4 million in non-cash benefits resulting from $7.5 million of depreciation and amortization,
an impairment charge of $1.5 million recorded to write off the project development costs previously capitalized following
our decision to terminate an automation project, $14.2 million of stock-based compensation expense, $0.3 million of
inventory excess adjustments, $0.2 million of premium amortization and discount accretion on investment securities, $4.1
million of remeasurement loss on changes in the fair value of our warrant liability; $2.6 million of interest accrued on our
Credit Line and under a 2018 settlement agreement related to reimbursement claims, as well as amortization of debt
discount in connection with our 2017 Term Loan, and other insignificant items. Operating assets generated cash outflows
of $20.0 million primarily due to an $18.1 million increase in accounts receivable and a $4.9 million increase in inventory,
offset by a $2.7 million reduction in prepaid expenses and other current assets and a $0.3 million decrease in other assets.
Operating liabilities generated cash inflows of $47.2 million due to an increase in accounts payable of $3.8 million, an
increase in accrued compensation of $3.0 million, an increase in deferred revenue of $42.8 million primarily driven by
prepaid sales-based royalties and performance obligations not yet delivered to Qiagen, as well as undelivered storage
services from our Evercord business, offset by decreases in other accrued liabilities of $1.8 million and deferred rent of
$0.7 million.
Cash (Used in) Provided by Investing Activities
Cash used in investing activities for the year ended December 31, 2019 totaled $266.4 million, which was
comprised of purchasing new investments of $446.6 million, acquisitions of property, plant and equipment of $5.0 million,
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offset by $175.5 million in proceeds resulting from sales and maturities of investments and proceeds of 9.7 million from
the disposal of Evercord.
Cash used in investing activities for the year ended December 31, 2018 totaled $5.2 million, which was comprised
of $169.0 million in proceeds resulting from sales and maturities of investments, offset by purchases of investments of
$170.3 million and acquisitions of property and equipment of $3.9 million. Acquisitions of property and equipment were
primarily related to the build-out of our Tukwila, Washington storage facility for our Evercord business, development of
software for our patient portal and our Evercord business, and leasehold improvements made to secure additional
laboratory space at our San Carlos, California headquarters.
Cash Provided by Financing Activities
Cash provided by financing activities for the year ended December 31, 2019 totaled $340.8 million, of which
$323.4 million was related to funds raised from the equity offering to sell shares of our common stock in April and
October 2019, net of issuance costs. The remaining $17.4 million was proceeds from exercise of stock options and shares
purchased from the employee stock purchase plan.
Cash provided by financing activities for the year ended December 31, 2018 totaled $113.7 million, of which
$96.8 million was related to funds raised from the equity offering to sell shares of our common stock in July 2018, net of
issuance costs. The remaining $16.9 million was proceeds from exercise of stock options and shares purchased from the
employee stock purchase plan.
Contractual Obligations and Other Commitments
See “Liquidity and Capital Resources” for a description of our contractual obligations under the Credit Line and
the 2017 Term Loan.
The following table summarizes our contractual obligations as of December 31, 2019:
Total
Less Than
1 Year
Payments Due by Period
1 to 3
Years
(In thousands)
3 to 5
Years
More Than
5 Years
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 42,138 $ 8,825 $ 18,386 $ 10,197 $
Short-term debt(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt facility(2) . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest accrued on debt(3) . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory purchase and other contractual obligations(4) . .
49,000
—
1,123
20,559
—
75,000
—
—
49,000
75,000
1,123
29,434
—
—
—
8,875
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 196,695 $ 79,507 $ 27,261 $ 85,197 $
4,730
—
—
—
—
4,730
(1) Represents proceeds drawn from our Credit Line.
(2) Represents proceeds from our 2017 Term Loan, which will mature in August 2024.
(3) Represents interest accrued on our Credit Line of $1.1 million.
(4) Represents various inventory purchase and other contractual obligations. Please refer to contractual commitments
disclosures provided in Note 8, Commitments and contingencies for details.
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Operating Lease Obligations
In October 2016, we entered into a lease directly with the landlord for laboratory and office spaces at our corporate
headquarters located in San Carlos, California. We currently occupy approximately 136,000 square feet comprised of two
office spaces (the “First Space” and the “Second Space”). The First Space covers approximately 88,000 square feet, and
the Second Space totals approximately 48,000 square feet. The term of this lease is approximately 84 months and expires
in October 2023. This lease contains an option to renew the lease term for five years, but the fair market rent amount upon
renewal is not available from the landlord.
In addition, we entered into a sublease agreement in June 2019 with a third party to sublease 25,879 square feet
of space located on the third floor of the San Carlos, California building while maintaining our primary obligation as the
intermediate lessor. The term of this lease is approximately 48 months commencing in October 2019 and expiring in
September 2023. The yearly lease payment starts at $1.9 million and will escalate annually starting in October 2020.
In March 2018, we entered into a lease for its cord blood tissue storage facility in Tukwila, Washington that
covers approximately 10,000 square feet. The lease term of this facility began in June 2018 with rent payment commencing
in August 2018. The lease term is 62 months expiring in July 2023. We have the option to extend this lease for five years,
and the fair market rent upon renewal is not determinable. However, since we sold our business related to cord blood and
tissue storage in September 2019, it is expected we will sublet the facility and will not exercise our option to renew the
facility upon expiration.
In September 2015, our subsidiary entered into a long-term lease agreement for laboratory and office space
totaling approximately 94,000 square feet in Austin, Texas. The lease term is 132 months beginning in December 2015
and expiring in November 2026 with monthly payments beginning in December 2016.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.
ITEM 7A: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest
rates. Our Credit Line has an interest rate of one-month LIBOR plus 1.10%. The LIBOR is variable. Our 2017 Term Loan
has an interest rate of three-month variable LIBOR plus 8.75%. An incremental change in the borrowing rate of 100 basis
points would increase our annual interest expense by approximately $1.3 million based on our $125.1 million debt
outstanding, including principal and accrued interest as of December 31, 2019.
Our investment portfolio is also exposed to market risk from changes in interest rates. This risk is mitigated as
we have maintained a relatively short average maturity for our investment portfolio. An incremental change in the
borrowing rate of 100 basis points would increase our annual interest income by approximately $3.8 million annually in
relation to amounts we would expect to earn, based on our short-term investments as of December 31, 2019.
Foreign Currency Exchange Rate Fluctuations
Our operations are currently conducted primarily in the United States. As we expand internationally, our results
of operations and cash flows may become subject to fluctuations due to changes in foreign currency exchange rates. In
periods when the U.S. dollar declines in value as compared to the foreign currencies in which we incur expenses, our
foreign-currency based expenses will increase when translated into U.S. dollars. In addition, future fluctuations in the
value of the U.S. dollar may affect the price at which we sell our tests outside the United States. To date, our foreign
currency risk has been minimal and we have not historically hedged our foreign currency risk; however, we may consider
doing so in the future.
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ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
NATERA, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Balance Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Operations and Comprehensive Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Stockholders’ Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page No.
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93
94
95
96
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Natera, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Natera, Inc. (the Company) as of December 31, 2019
and 2018, and the related consolidated statements of operations and comprehensive loss, stockholders' equity 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 "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material
respects, the financial position of the Company at 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 U.S. generally accepted
accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the Company’s internal control over financial reporting as of December 31, 2019, based on criteria established
in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 framework) and our report dated February 28, 2020 expressed an unqualified opinion thereon.
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 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. 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.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements
that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or
disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or
complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the
consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
91
Genetic Test Revenue
Description of
the Matter . . . .
For the year ended December 31, 2019, the Company’s revenue from sales of genetic tests was
$269.9 million. As explained in Note 3 of the consolidated financial statements, revenue from
genetic tests is recognized upon delivery of the test results. The revenue recognized for the genetic
tests is based on an estimate of the total consideration expected to be received for the genetic
tests. In particular, the estimate of total consideration is affected by assumptions of reimbursement
from patients and insurance carriers, including estimates for disallowed cases, discounts, refunds
and doubtful accounts.
Auditing the measurement of the Company’s genetic test revenue was complex as it requires
significant judgement to evaluate the assumptions and inputs utilized by management in
determining the total consideration to be received by the Company for delivered tests and the
amounts involved are material to the financial statements taken as a whole.
How We
Addressed the
Matter in
Our Audit . . . .
We obtained an understanding, evaluated the design, and tested the operating effectiveness of
internal controls that address the risks of material misstatement relating to the measurement of
genetic test revenues. This included testing controls related to management’s review of the
significant assumptions and inputs used in the determination of the estimated amount that would
be collected for tests performed during the period. We also tested controls over the current and
historical data used by management in determining this estimate, including the completeness and
accuracy of the data.
We performed audit procedures that included, among others, assessing methodologies and testing
the significant assumptions discussed above and the underlying data used by the Company in its
analysis. We compared the significant assumptions used by management to those used in prior
periods and examined evidence regarding the changes in assumptions.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2012
San Jose, California
February 28, 2020
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Natera, Inc.
Consolidated Balance Sheets
(In thousands, except par value per share amount)
December 31, December 31,
2019
2018
Assets
Current assets:
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Restricted cash, current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net of allowance of $2,919 in 2019 and $1,788 in 2018 . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease right-of-use assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
46,407
61,926 $
4,597
55
107,461
379,065
62,223
53,351
13,633
12,394
6,197
16,376
240,518
523,167
24,336
23,283
—
23,730
3,317
12,476
582,656 $ 268,171
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term debt financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred rent, net of current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, long-term portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities, long-term portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $0.0001 par value: 50,000 shares authorized; no shares issued and
8,604 $
16,088
49,043
56,016
50,123
179,874
73,656
—
23,808
26,297
310
303,945
14,587
12,668
32,442
4,131
50,153
113,981
73,357
8,613
40,058
—
—
236,009
outstanding at December 31, 2019 and 2018, respectively . . . . . . . . . . . . . . . . . . . . .
—
—
Common stock, $0.0001 par value: 750,000 shares authorized at December 31,
2019 and 2018, respectively; 78,005 and 62,083 shares issued and outstanding at
December 31, 2019 and 2018, respectively . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
7
8
607,236
976,955
(574,529)
(699,171)
(552)
919
278,711
32,162
582,656 $ 268,171
See accompanying notes.
93
Natera, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
Year ended December 31,
2018
2017
2019
Revenues
Product revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 269,881 $ 240,366 $ 203,777
5,848
Licensing and other revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
209,625
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32,447
302,328
17,288
257,654
Cost and expenses
Cost of product revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
158,081
Cost of licensing and other revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7,974
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
51,355
Selling, general and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
154,872
—
Gain from disposal of business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total cost and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
372,282
Loss income from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(114,628)
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(10,476)
Interest and other (expense) income, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2,729)
Loss before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(127,833)
(321)
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (124,827) $ (128,154)
Unrealized gain (loss) on available-for-sale securities, net of tax . . . . . . . . .
214
Comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (123,356) $ (127,940)
162,604
12,866
51,357
206,176
(14,388)
418,615
(116,287)
(10,693)
4,152
(122,828)
(1,999)
1,471
135,508
4,088
50,064
155,306
—
344,966
(135,341)
(4,213)
2,380
(137,174)
(454)
$ (137,628)
(41)
$ (137,669)
Net loss per share (Note 15):
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(1.79) $
(1.79) $
(2.22) $
$
(2.22)
(2.58)
(2.59)
Weighted-average number of shares used in computing basic and diluted
net loss per share:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
69,555
69,555
57,848
57,848
53,312
53,604
See accompanying notes.
94
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Natera, Inc.
Consolidated Statements of Cash Flows
(In thousands)
Operating activities:
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-cash lease expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment of assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory excess adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for doubtful accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Premium amortization and discount accretion on investment securities . . . . . . . . . . . . . . . . .
(Gain) loss realized on investment securities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Gain) loss on sales of property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss (gain) from changes in fair value of warrants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest accrued for borrowings and claims related settlement . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of debt discount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other non-cash (benefits) charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gain on disposal of business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in operating assets and liabilities:
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred rent, net of current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investing activities:
Purchases of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sale of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from maturity of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net proceeds from disposal of business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash (used in) provided by investing activities . . . . . . . . . . . . . . . . . . . . . . . . . .
Financing activities:
Proceeds from exercise of stock options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of common stock under employee stock purchase plan . . . . . . . . . . . . . .
Proceeds from equity offering, net of issuance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Borrowings under long-term debt facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payment for debt issuance costs on long-term debt facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Borrowings under credit facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayment under credit facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) in cash, cash equivalents and restricted cash . . . . . . . . . . . . . . . . . . . . . .
Cash, cash equivalents and restricted cash, beginning of period . . . . . . . . . . . . . . . . . . . . . . . . .
Cash, cash equivalents and restricted cash, end of period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Supplemental disclosure of cash flow information:
Cash paid for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash paid for interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-cash investing and financing activities:
Purchases of property and equipment in accounts payable and accruals . . . . . . . . . . . . . . . . . . . .
Issuance of common stock for exercise of warrants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock for lender's commitment to debt financing . . . . . . . . . . . . . . . . . . . . .
$
$
$
$
$
Year Ended December 31,
2018
2017
2019
(124,827)
$
(128,154)
$
(137,628)
7,730
7,748
1,671
28,624
321
1,141
945
(16)
—
—
—
457
(51)
(14,388)
2,418
917
(13,956)
(9,099)
(6,262)
3,419
8,606
40,848
—
310
(63,444)
(446,626)
1,666
173,900
9,675
(4,968)
(266,353)
13,041
4,323
323,410
—
—
—
—
340,774
7,501
—
1,544
14,198
265
(41)
238
43
(12)
4,118
2,172
391
—
—
(18,093)
(4,900)
2,643
335
3,781
3,069
(1,820)
42,769
(628)
—
(70,581)
(170,268)
37,387
131,600
—
(3,880)
(5,161)
13,331
3,617
96,777
—
—
—
—
113,725
10,977
51,004
61,981 $
37,983
13,021
51,004 $
2,154
12,455
3,706
—
—
$
$
$
$
$
332
7,914
268
6,762
—
$
$
$
$
$
7,143
—
576
11,402
502
143
857
64
12
(1,148)
488
154
—
—
6,315
(3,086)
(1,515)
600
217
(1,467)
14,919
846
1,452
1,329
(97,825)
(272,819)
65,270
231,200
—
(9,867)
13,784
2,315
3,344
—
75,000
(287)
—
—
80,372
(3,669)
16,690
13,021
177
3,568
447
—
2,448
See accompanying notes
96
Natera, Inc.
Notes to Consolidated Financial Statements
1. Description of Business
Natera, Inc. (the "Company") was formed in the state of California as Gene Security Network, LLC in
November 2003 and incorporated in the state of Delaware in January 2007. The Company’s mission is to change the
management of genetic disease worldwide. The Company operates a laboratory certified under the Clinical Laboratory
Improvement Amendments ("CLIA") providing a host of preconception and prenatal genetic testing services. The
Company determines its operating segments based on the way it organizes its business to make operating decisions and
assess performance. The Company has only one operating segment, which is the discovery, development and
commercialization of genetic testing services, and it has a subsidiary that operates in the state of Texas.
The Company's product offerings include its Panorama Non-Invasive Prenatal Test ("NIPT") that screens for
chromosomal abnormalities of a fetus typically with a blood draw from the mother; Vistara (“Vistara”), a single-gene
mutations screening test performed to identify single-gene disorders; Horizon Carrier Screening ("HCS") to determine
carrier status for a large number of severe genetic diseases that could be passed on to the carrier’s children; Spectrum to
analyze chromosomal anomalies or inherited genetic conditions during an in vitro fertilization ("IVF") cycle to select
embryos for the highest probability of a successful pregnancy; Anora Products of Conception ("POC") test to rapidly and
extensively analyze fetal chromosomes to understand the cause of miscarriage; Non-Invasive Paternity Testing ("PAT"),
to determine paternity by analyzing the fragments of fetal deoxyribonucleic acid ("DNA") in a pregnant mother's blood
and a blood sample from the alleged father(s), which is marketed and sold by a licensee from whom the Company receives
a royalty. All testing is available principally in the United States, and the Company also offers its Panorama test to
customers primarily in Europe. The Company also offers Constellation (“Constellation”), a cloud-based software product
that allows laboratory customers to gain access through the cloud to the Company’s algorithms and bioinformatics in order
to validate and launch tests based on the Company’s technology. The Company also offers Signatera (“Signatera”), a
circulating tumor DNA technology that analyzes and tracks mutations specific to an individual's tumor. The Company
offered Evercord, a cord blood and cord tissue processing and storage service, through September 2019. The Evercord
service line was sold to a third-party buyer in September 2019 (Note 13). Further, the Company has expanded its Panorama
test to now screen twin pregnancies for zygosity and chromosomal abnormalities.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with U.S. generally
accepted accounting principles (“U.S. GAAP”).
Liquidity Matters
The Company has incurred net losses since its inception and anticipates net losses and negative operating cash
flows for the near future. For the year ended December 31, 2019, the Company had a net loss of $124.8 million, which
increased the accumulated deficit to $699.2 million from $574.5 million at December 31, 2018 following the modified
retrospective adoption of ASU 2018-07, which required a cumulative-effect adjustment to accumulated deficit as of the
earliest period presented in the consolidated financial statements. At December 31, 2019, the Company had $62.0 million
in cash, cash equivalents and restricted cash, $379.1 million in marketable securities, $50.1 million of outstanding balance
of the Credit Line (as defined in Note 10) including accrued interest, and $73.7 million of net carrying amount of the 2017
Term Loan (as defined in Note 10). While the Company has introduced multiple products that are generating revenues,
these revenues have not been sufficient to fund all operations. Accordingly, the Company has funded the portion of
operating costs that exceeds revenues through a combination of equity issuances, debt issuances, and other financing.
97
The Company continues to develop and commercialize future products and, consequently, it will need to generate
additional revenues to achieve future profitability and may need to raise additional equity or debt financing. If the Company
raises additional funds by issuing equity securities, its stockholders would experience dilution. Additional debt financing,
if available, may involve covenants restricting its operations or its ability to incur additional debt. Any additional debt
financing or additional equity that the Company raises may contain terms that are not favorable to it or its stockholders
and require significant debt service payments, which diverts resources from other activities. Additional financing may not
be available at all, or in amounts or on terms acceptable to the Company. If the Company is unable to obtain additional
financing, it may be required to delay the development, commercialization and marking of its products and significantly
scale back its business and operations.
On April 23, 2019, the Company completed an underwritten equity offering to sell 5,263,158 shares of its
common stock at a price to the public of $19 per share. On April 26, 2019, the Company sold an additional 789,473 shares
of its common stock to the underwriters at the same price upon their exercise of the option to purchase those shares. Before
offering expenses of $0.6 million, the Company received proceeds of $108.1 million net of the underwriting discount.
On October 17, 2019, the Company completed an underwritten equity offering to sell 5,714,286 shares of its
common stock at a price to the public of $35 per share. The same day, the Company sold an additional 857,142 shares of
its common stock to the underwriters at the same price upon their exercise of the option to purchase those shares. Before
offering expenses of $0.4 million, the Company received proceeds of $216.2 million net of the underwriting discount.
Based on the Company’s current business plan, the Company believes that its existing cash and marketable
securities will be sufficient to meet its anticipated cash requirements for at least 12 months after February 28, 2020.
Principles of Consolidation
The accompanying consolidated financial statements include all the accounts of the Company and its subsidiary.
The Company established a subsidiary that operates in the state of Texas to support the Company’s laboratory and
operational functions. All intercompany balances and transactions have been eliminated.
Use of Estimates
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates
and assumptions about future events that affect the amounts of assets and liabilities reported, disclosures about contingent
assets and liabilities, and reported amounts of revenues and expenses. Significant items subject to such estimates include
the allowance for doubtful accounts, deferred revenues associated with unsatisfied performance obligations, accrued
liability for potential refund requests, stock-based compensation, the fair value of common stock and warrants, income tax
uncertainties, and the expected consideration to be received from contracts with customers. These estimates and
assumptions are based on management's best estimates and judgment. Management regularly evaluates its estimates and
assumptions using historical experience and other factors, including contractual terms and statutory limits; however, actual
results could differ from these estimates and could have an adverse effect on the Company's financial statements.
Fair Value
The Company discloses the fair value of financial instruments for financial assets and liabilities for which the
value is practicable to estimate. Fair value is defined as the price that would be received upon the sale of an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and money market deposits with financial institutions.
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Restricted Cash
The Company discloses both short-term and long-term restricted cash. As of December 31, 2019, short-term
restricted cash totaled $0.1 million and long-term restricted cash totaled zero in cash deposits held as collateral for the
settlement of foreign currency transactions and deposit per credit card terms.
In the first quarter of 2019, the Company paid the final quarterly installment of $1.4 million in connection with a
2018 settlement agreement relating to reimbursement-related claims, and accordingly, the restriction imposed on the $4.2
million cash deposits to secure the letter of credit required under the settlement agreement was released.
Restricted cash is currently presented as a separate line item in the Company’s balance sheet. In the statements
of cash flows, it is included together with cash and cash equivalents and considered as part of the total ending cash balance.
The following is the reconciliation between how restricted cash is presented in the balance sheet and the statements of
cash flows for all periods presented:
Cash and cash equivalents in balance sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Restricted cash, current portion in balance sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total cash, cash equivalents and restricted cash in statements of cash flows . . . . . . . . . . . . $
61,926 $
55
61,981 $
46,407
4,597
51,004
December 31, December 31,
2019
2018
(in thousands)
Investments
Investments consist primarily of debt securities such as U.S. Treasuries, U.S. agency and municipal bonds.
Management determines the appropriate classification of securities at the time of purchase and reevaluates such
determination at each balance sheet date. The Company generally classifies its entire investment portfolio as available-
for-sale. The Company views its available-for-sale portfolio as available for use in current operations. Accordingly, the
Company classifies all investments as short-term, even though the stated maturity may be more than one year from the
current balance sheet date. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported
in accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity.
Risk and Uncertainties
The Company has various financial instruments that are potentially subjected to credit risk, and they consist of
cash, accounts receivable and investments. The Company limits its exposure to credit loss by placing its cash in financial
institutions with high credit ratings. The Company's cash may consist of deposits held with banks that may at times exceed
federally insured limits. The Company performs evaluations of the relative credit standing of these financial institutions
and limits the amount of credit exposure with any one institution.
The Company bills third-party payers for certain tests performed. The amount that is ultimately received from
the payer for the Company’s claim and the timing of such payments are subject to the determination of the payer based on
the nature of the test performed and their view of the Company’s business practices with respect to collections of plan
deductibles and co-payments from patients and other activities. This determination can impact both the amount and timing
of when the Company’s invoices are collected. Payers may also withhold payments and request refunds of prior payments
if the payer asserts that the Company has not performed in accordance with the policies of these payers.
The Company performs evaluations of financial conditions for clinics and laboratory partners and generally does
not require collateral to support credit sales. In 2019, 2018 and 2017, there were no customers exceeding 10% of total
revenues on an individual basis. As of December 31, 2019 and 2018, there were no customers with an outstanding balance
exceeding 10% of net accounts receivable.
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Allowance for Doubtful Accounts
Trade accounts receivable are recorded at the amount billed to the laboratory partners and clinics, insurance
payers, oncologists, pharmaceutical companies, and patients. Reducing this amount is an allowance for doubtful accounts
for estimated losses resulting from the inability of its customers to make the contracted payments. Management analyzes
accounts receivable and historical bad debt experience, customer creditworthiness, current economic trends, and changes
in customer payment history when evaluating the adequacy of the allowance for doubtful accounts. Accounts receivable
are written off against the allowance when there is substantive evidence that the account will not be paid.
Revenue Recognition
The Company adopted the new revenue recognition guidance, ASC 606, beginning January 1, 2018 on a full
retrospective basis. ASC 606 mandates revenue recognition to be evaluated using the following five steps:
Identification of a contract, or contracts, with a customer;
Identification of the performance obligations in the contract;
•
•
• Determination of the transaction price;
• Allocation of the transaction price to the performance obligations in the contract; and
• Revenue recognition when, or as, the performance obligations are satisfied
See Note 3, Revenue Recognition, for detailed discussions of product revenues, licensing and other revenues, and
how the five steps described above are applied.
Cost of Product Revenues
The components of cost of product revenues are material and service costs, impairment charges associated with
testing equipment, personnel costs, including stock-based compensation expense, equipment and infrastructure expenses
associated with testing samples, electronic medical record, order and delivery systems, shipping charges to transport
samples, third-party test processing fees and allocated overhead including rent, information technology costs, equipment
depreciation and utilities. Costs associated with the performance of diagnostic services are recorded as tests are accessioned.
Cost of Licensing and Other Revenues
The components of cost of licensing and other revenues are material costs associated with test kits, engineering
costs incurred by the research and development team to improve and maintain the Constellation software platform,
amortization of Constellation software development costs, development and support services relating to our strategic
partnership agreements, and costs associated with specimens and Whole Exome Sequencing (“WES”) relating to our
Signatera offering. Costs also include labor and other costs of development activities, collection kits consumed during the
processing of cord blood samples, processing service and storage of the cord blood samples, and freight charged to
transport the samples to the storage facility. Through the third quarter of 2019, cost of licensing and other revenues also
includes costs associated with Evercord (See Note 13, Disposal of Business).
Research and Development
The Company records research and development costs in the period incurred. Research and development costs
consist of personnel costs, contract services, cost of materials utilized in performing tests, costs of clinical trials and
allocated facilities and related overhead expenses.
Advertising Costs
The Company expenses advertising costs as incurred. The Company incurred advertising costs of $0.2 million,
$0.2 million and $0.5 million for the years ended December 31, 2019, 2018 and 2017, respectively.
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Product Shipment Costs
The Company expenses product shipment costs in cost of product revenues in the accompanying statements of
operations. Shipping and handling costs for the years ended December 31, 2019, 2018 and 2017 were $13.3 million, $12.4
million and $9.5 million, respectively.
Income Taxes
Income taxes are recorded in accordance with Financial Accounting Standards Board ASC Topic 740, Income
Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the
year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely
than not that a tax position will be sustained during an audit. Deferred tax assets are reduced by a valuation allowance if
current evidence indicates that it is considered more likely than not that these benefits will not be realized.
Stock-Based Compensation
Stock-based compensation related to stock options and restricted stock units (“RSUs”) granted to the Company’s
employees is measured at the grant date based on the fair value of the award. The fair value is recognized as expense over
the requisite service period, which is generally the vesting period of the respective awards. No compensation cost is
recognized when the requisite service has not been met and the awards are therefore forfeited.
For stock options with market conditions, the Company derives the requisite service period using the Monte Carlo
simulation model. For stock options and RSUs that vest upon meeting performance conditions or market conditions in
combination with performance conditions, the Company derives the requisite service period from the grant date to the date
it is probable that the vesting conditions will be met.
The Company also recognizes stock-based compensation from option awards and RSUs granted to non-
employees. Prior to January 1, 2019, the fair value of non-employee awards was subject to remeasurement at the end of
each reporting period until the vesting date of such awards, and the resulting change in fair value was recognized in the
Company's statements of operations and comprehensive loss during the period that the related services were rendered.
On January 1, 2019, the Company adopted ASU 2018-07, which allows the accounting for nonemployee awards
to be treated the same as for employee awards. The fair value of non-employee awards is now determined based on a one-
time measurement at the grant date, and it is no longer subject to periodic remeasurement. The Company continues to
recognize stock-based compensation expense as services are rendered by the non-employees over the vesting period, which
is accounted for on a straight-line basis. See further discussion under the Recently Adopted Accounting Pronouncements
section within this footnote, as well as the election of certain accounting policy as a result of the adoption.
The Company uses the Black‑Scholes option‑pricing model and the Monte Carlo simulation model to estimate
the fair value of stock options issued to employees and non-employees. The model requires the input of the Company's
expected stock price volatility, the expected term of the awards, and a risk-free interest rate. Determining these assumptions
requires significant judgment. See further discussion on the valuation assumptions used under Note 9.
Warrants
The Company accounts for warrants to purchase shares of its common stock as a liability at fair value on the
balance sheet date because the Company may be obligated to redeem these warrants at some point in the future. The
warrants are subject to remeasurement at each balance sheet date, with changes in fair value recognized as a gain or loss
from the changes in fair value of the warrants in the statements of operations and comprehensive loss. Further adjustments
resulting from changes in fair value are no longer required as the warrants were fully exercised in June 2018.
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Capitalized Software Held for Internal Use
The Company capitalizes salaries and related costs of employees and consultants who devote time to the
development of internal-use software development projects. Capitalization begins during the application development
stage, once the preliminary project stage has been completed, which includes successful validation and approval from
management. If a project constitutes an enhancement to previously developed software, the Company assesses whether
the enhancement is significant and creates additional functionality to the software, thus qualifying the work incurred for
capitalization. Once the project is available for general release, capitalization ceases and the Company estimates the useful
life of the asset and begins amortization. The Company periodically assesses whether triggering events are present to
review internal-use software for impairment. Changes in estimates related to internal-use software would increase or
decrease operating expenses or amortization recorded during the reporting period. Refer to Property and Equipment, net
under Note 6 for more detail regarding an impairment charge recorded to write off certain project development costs during
the first quarter of 2018.
The Company amortizes its internal-use software over the estimated useful lives of three years. The net book
value of capitalized software held for internal use was $1.2 million and $1.7 million as of December 31, 2019 and 2018,
respectively. Amortized expense for amounts previously capitalized for the years ended December 31, 2019, 2018 and
2017 was $1.2 million, $1.3 million and $1.0 million, respectively. In addition, the Company recorded $0.1 million of
impairment expense in relation to the disposal of business in the year ended December 31, 2019.
Accumulated Other Comprehensive Income (Loss)
Comprehensive income (loss) and its components encompass all changes in equity other than those with
stockholders, and include net loss, unrealized gains and losses on available-for-sale marketable securities. As of
December 31, 2019, and 2018, accumulated other comprehensive income (loss) consisted of $0.9 million of unrealized
gains on available-for sale marketable securities and $0.6 million of unrealized losses on available-for-sale marketable
securities. See Note 5, Financial Instruments, for additional disclosures related to change in net unrealized losses and
reclassifications out of accumulated other comprehensive loss upon the sale of available-for-sale marketable securities.
Property and Equipment
Property and equipment, including purchased and internally developed software, are stated at cost. Depreciation
is calculated using the straight-line method over the estimated useful lives of the assets, which are generally three to five
years. Leasehold improvements are amortized using the straight-line method over the estimated useful lives of the assets
or the remaining term of the lease, whichever is shorter. The Company periodically reviews the depreciable lives assigned
to property and equipment placed in service and change the estimates of useful lives to reflect the results of such reviews.
Impairment of Long-lived Assets
The Company evaluates its long-lived assets for indicators of possible impairment when events or changes in
circumstances indicate the carrying amount of an asset may not be recoverable. The Company then compares the carrying
amounts of the assets with the future net undiscounted cash flows expected to be generated by such asset. Should an
impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s
fair value determined using discounted estimates of future cash flows. See Note 6 for more detail about assets impairment.
Inventory
Inventory is valued at the lower of the standard cost, which approximates actual cost, or market. Cost is
determined using the first-in, first-out ("FIFO") method. Inventory consists entirely of supplies, which are consumed when
providing its test reports, and therefore does not maintain any finished goods inventory. The Company enters into inventory
purchases and commitments so that it can meet future delivery schedules based on forecasted demand for its tests.
The Company recorded inventory obsolescence charges totaling $0.3 million, $0.3 million, and $0.5 million in
the years ended December 31, 2019, 2018, and 2017, respectively.
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Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the
“FASB”) under its accounting standard codifications (“ASC”) or other standard setting bodies and adopted by the
Company as of the specified effective date. Unless otherwise discussed below, the Company believes that the impact of
recently issued standards that are not yet effective will not have a material impact on its financial position or results of
operations upon adoption.
Recently Adopted Accounting Pronouncements
Leases
On January 1, 2019, the Company adopted ASU 2016-02 and concurrently elected to adopt ASU 2018-11, which
are collectively known as ASC 842, Leases (“ASC 842”). ASU 2018-11 provides an alternative transition method such
that the initial application of the new lease accounting standards can be completed as of January 1, 2019 using the modified
retrospective approach instead of the earliest period presented. The financial results in the statement of operations and
comprehensive loss for the year ended December 31, 2018 and the balance sheet as of December 31, 2018 were not
retroactively restated. As a result of electing the transition guidance as described above, on January 1, 2019, the Company
recorded operating right-of-use assets of $28.2 million, including the derecognition of deferred rent of $9.5 million and
prepaid rent of $0.7 million, with the corresponding lease liabilities totaling $37.0 million. There was no material impact
to the Company’s statements of operations and comprehensive loss upon adoption.
Upon transition, the Company has elected the package of practical expedients available under ASC 842, which
allows the Company not to reassess (i) whether any expired or existing contracts as of the transition date are or contain a
lease, (ii) lease classification for any expired or existing leases as of the transition date, and (iii) initial direct costs for any
existing leases as of the transition date. The Company has decided not to elect the practical expedient on applying hindsight
in determining the lease term and the impairment of the right-of-use assets. See Note 7, Leases, for more detail information
regarding the accounting for operating leases.
Non-employee stock-based compensation
Effective January 1, 2019, the Company transitioned to the new accounting requirements under ASU 2018-07 for
non-employee stock-based awards using the modified retrospective approach. The new guidance aligns the accounting
treatment for both the employee and non-employee stock-based awards, which simplifies the fair value measurement
process by requiring a one-time valuation of the non-employee stock options as of the grant date. Upon transition, the
Company performed the final fair value remeasurement for its existing unvested non-employee stock-based awards, which
included stock options and restricted stock units, up until the transition date, and adjusted the amount of the cumulative
stock-based compensation expense accordingly by $0.2 million. The Company recorded this amount as a cumulative-
effect adjustment to the opening balance of accumulated deficit in its balance sheet.
Under the new guidance, the Company is permitted to carry-over the method it has used to recognize stock-based
compensation expense from non-employee awards, which is accounted for on a straight-line basis as services are rendered
over the vesting period. However, there are certain accounting options available for election in connection with estimated
forfeitures and the valuation input for the expected term or remaining contractual term. The Company has elected to
account for the actual forfeitures upon the cancellation of the awards, and to use of the same expected term valuation input
as it uses for employee awards.
Reclassification of tax effects from accumulated other comprehensive income
The Company adopted ASU 2018-02 on January 1, 2019, which was established as a result of the Tax Cuts and
Jobs Act passed in December 2017 and provided an opportunity for entities to reclassify residual income tax effects from
accumulated other comprehensive income to retained earnings due to the reduction of the corporate income tax rate. Upon
adoption, the Company had the option to apply this new guidance using either the full retrospective approach or to record
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the reclassifications as of the adoption date. As of January 1, 2019, the Company had a full valuation allowance reserved
against its deferred tax assets, and as a result, there was no restatement or reclassification required.
New Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses: Measurement of Credit
Losses on Financial Instruments and also issued subsequent amendments to the initial guidance: ASU 2018-19, ASU
2019-04, ASU 2019-05, and ASU 2019-11. The standard requires measurement and recognition of expected credit losses
for financial assets by requiring an allowance to be recorded as an offset to the amortized cost of such assets. For available-
for-sale debt securities, expected credit losses should be estimated when the fair value of the debt securities is below their
associated amortized costs. The standard will become effective for the Company in the first quarter of 2020, with early
adoption permitted beginning the first quarter of 2019. The modified retrospective approach should be applied upon
adoption of this new guidance. The Company’s financial instruments that are in the scope of ASU 2016-13 include but not
limited to trade receivables and available-for-sale debt securities. The Company will adopt this standard on January 1,
2020 and does not anticipate this amendment to have a material impact on the consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—
Changes to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 proposes new disclosure
requirements for unrealized gains or losses recognized in other comprehensive income that are attributable to fair value
changes in assets and liabilities categorized within Level III of the fair value hierarchy, as well as quantitative information
about significant unobservable inputs used to value such assets and liabilities. It eliminates the requirement to disclose the
reasons for the transfers of assets and liabilities measured in fair value on a recurring basis between Level I and Level
II. ASU 2018-13 is effective for the Company for fiscal years beginning after December 15, 2019, including interim
periods within that fiscal year, with early adoption permitted. The Company will adopt this standard on January 1, 2020
and does not anticipate this amendment to have a material impact on the consolidated financial statements.
In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software
(Subtopic 350-40) - Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That
Is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting
arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or
obtain internal-use software. ASU 2018-15 is effective for the Company for fiscal years beginning after December 15,
2019, including interim periods within that fiscal year, with early adoption permitted. The standard can be applied either
prospectively to implementation costs incurred after the date of adoption or retrospectively to all arrangements. The
Company intends to adopt this standard on January 1, 2020 using the prospective approach and the adoption is not
expected to have a material impact on its consolidated financial statements.
In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the
Interaction between Topic 808 and Topic 606, which clarifies that certain transactions between participants in a
collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, Topic
808 precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from
contracts with customers if the counterparty is not a customer for that transaction. ASU 2018-18 is effective for the
Company for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year, with early
adoption permitted. The Company will adopt this standard on January 1, 2020 and does not anticipate this amendment to
have a material impact on the consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic
740), which simplifies the accounting for income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and
clarifies certain aspects of the current guidance to promote consistency among reporting entities. ASU 2019-12 is effective
for fiscal years beginning after December 15, 2020. The guidance will be effective for the Company in the first quarter of
our fiscal year 2021. The Company is currently evaluating the impact of the adoption of this standard on its consolidated
financial statements.
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3. Revenue Recognition
The Company recognizes revenues when, or as, performance obligations in the contracts are satisfied, in the
amount reflecting the expected consideration to be received from the goods or services transferred to the customers.
Product Revenues
Product revenues are derived from contracts with insurance carriers, laboratory partners and patients in
connection with sales of prenatal genetic tests. The majority of the Company’s revenues is derived from Panorama NIPT,
HCS (as defined in Note 1), and to a lesser extent, other genetic tests. The Company enters into contracts with insurance
carriers with primarily payment terms related to tests provided to the patients who have health insurance coverage.
Insurance carriers are considered as third-party payers on behalf of the patients, and the patients are considered as the
customers who receive genetic test services. Tests may be billed to insurance carriers, patients, or a combination of
insurance carriers and patients. Further, the Company sells tests to a number of domestic and international laboratory
partners and identifies the laboratory partners as customers provided that there is a test services agreement between the
two parties.
A performance obligation represents a promise in a contract to transfer a distinct good or service to a customer,
which represents a unit of accounting in accordance with ASC 606. A performance obligation is considered distinct from
other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources
that are readily available to the customer and is separately identified in the contract. The Company considers a performance
obligation satisfied once the Company has transferred control of a good or service to the customer, meaning the customer
has the ability to use and obtain the benefit of the good or service. A portion of the consideration should be allocated to
each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The
Company evaluates its contracts with insurance carriers, laboratory partners and patients and identifies a single
performance obligation in those contracts, which is the delivery of the test results.
The total consideration which the Company expects to collect in exchange for the Company’s products is an
estimate and may be fixed or variable. Consideration includes reimbursement from both patients and insurance carriers,
adjusted for variable consideration related to disallowed cases, discounts, refunds and doubtful accounts, and is estimated
using the expected value approach. For insurance carriers with similar reimbursement characteristics, the Company uses
a portfolio of relevant historical data to estimate variable consideration and total collections for the Company’s products.
The Company constrains the estimated variable consideration when it assesses it is probable that a significant reversal in
the amount of cumulative revenue recognized may occur in future periods. The consideration expected from laboratory
partners usually includes a fixed amount, but it can be variable depending on the volume of tests performed, and the
Company determines the variable consideration using the expected value approach. For insurance carriers, laboratory
partners and patients, the Company allocates the total consideration to a single performance obligation, which is the
delivery of the test results to the customers.
When assessing the total consideration for insurance carriers and patients, a certain percentage of revenues is
further constrained for estimated refunds.
The Company generally bills an insurance carrier, a laboratory partner or a patient upon delivery of test results.
The Company also bills patients directly for out-of-pocket costs involving co-pays and deductibles that they are responsible
for. Tests billed to insurance carriers and directly to patients usually take an average of nine to twelve months to collect
the payments, and for tests billed to laboratory distribution partners, the average collection cycle takes approximately two
to three months. At times, the Company may or may not get reimbursed for the full amount billed. Further, the Company
may not get reimbursed at all for tests performed if such tests are not covered under the insurance carrier’s reimbursement
policies or the Company is not a qualified provider to the insurance carrier, or if the tests were not previously authorized.
Product revenue is recognized in an amount that equals to the total consideration (as described above) at a point
in time when the test results are delivered. The Company reserves certain amounts in other accrued liabilities on the balance
sheet in anticipation of requests for refunds of payments previously made by insurance carriers, which are accounted for
as reductions in product revenues in the statement of operations and comprehensive loss. During the years ended December
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31, 2019, 2018, and 2017 $2.4 million, $3.3 million, and 4.9 million respectively, were released from amounts previously
held in reserves in other accrued liabilities and recognized as product revenue.
Licensing and Other Revenues
The Company recognizes licensing revenues from its cloud-based distribution service offering, Constellation, by
granting licenses to its licensees to use certain of the Company’s proprietary intellectual properties and cloud-based
software and IVD Kits. The Company also recognizes revenues from the Signatera (RUO) offering, the Qiagen LLC, BGI
Genomics, and Foundation Medicine, Inc. agreements, and the Evercord offering for the collection and storage of newborn
cord blood and cord tissue units. The Evercord business was sold on September 2019. See Note 13 – Disposal of Business
for additional information.
Constellation
The laboratory partners with which the Company enters into a licensing arrangement represent the licensees and
are identified as customers. The licensees do not have the right to possess the Company’s software, but rather receive the
software as a service. These arrangements often include: (i) the delivery of the software as a service, (ii) the necessary
support and training, and (iii) the reagent kits (“IVD kits”) to be consumed as tests are processed. The Company does not
consider the software as a service, the support and training as being distinct in the context of such arrangements, and
therefore they are combined as a single performance obligation. The software, support and training are delivered
simultaneously to the licensees over the term of the arrangement.
The Company provides IVD kits that are customized for its licensees to process tests using its cloud-based
software. IVD kits revenues are recognized based on their standalone selling price at a point in time upon delivery to the
licensees and expiration of their right of return.
The Company bills the majority of licensees, who process the tests in their laboratories, a fixed price for each test
processed. Licensing revenues are recognized as the performance obligations are satisfied (i.e., upon the delivery of each
test) and reported in licensing and other revenues in the statements of operations and comprehensive loss.
Signatera
The Company enters into agreements with pharmaceutical companies to utilize the Company’s Signatera tests
typically to study new cancer treatments or to validate the outcomes of clinical trials for which the pharmaceutical
companies are identified as customers. Such arrangements generally involve performing whole exome sequencing
(“WES”) services and the testing of patient samples to detect cancer mutations using its Signatera test. Each test is billable
to customers and the personalized cancer profile also makes each test distinct within the context of the contract as
customers can exercise control over the test results upon delivery. The company allocates the contract price to each test
using the stand-alone selling price for each service and recognizes the test processing revenue as individual test results are
delivered to customers.
Evercord
The Company recognized revenues from Evercord for the collection and storage of newborn cord blood and cord
tissue units. The patient entered into an enrollment agreement with the Company. According to the agreement, there are
two performance obligations: (i) the provision of a collection kit and the processing of newborn cord blood and cord tissue
units, which are considered delivered at the beginning of the process (the “processing services”), and (ii) the storage of the
cord blood and cord tissue units (the “storage services”), for either an annual fee or a prepayment covering an extended
period or the lifetime of the newborn donor.
The Company offered its processing services together with storage services, and each of them is capable of being
distinct, and is distinct in the context of the contract, and therefore, represents separate performance obligations. Evercord
customers may have paid for both processing and storage services over a period of six, 12, or 18 months. The transaction
price for the processing and storage services was calculated as the stated contract price, adjusted for discounts, refunds,
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and significant financing components. The Company determined that the transaction price represents the standalone selling
prices that are observable in the market for both the processing and storage services. The total consideration was allocated
between the processing services and storage services based on their standalone selling prices.
Upon the completion of the processing services, the Company issued a certificate of preservation indicating that
the cord blood and cord tissue units are ready for storage, and processing revenues were recognized at this particular point
in time. Storage revenues were recognized over time, which is the applicable storage period. The Company believes the
methodology of recognizing storage revenues over time meaningfully depicts the timing of storage services delivered to
customers as it exerts the necessary efforts to deliver such services equally over time. Evercord revenues are reported in
licensing and other revenues in the statements of operations and comprehensive loss through the period the Evercord
business was sold in September 2019.
Qiagen
In March 2018, the Company entered into a License, Development and Distribution Agreement (“the Qiagen
Agreement”) with Qiagen LLC under which the Company granted Qiagen a license to develop, manufacture, distribute
and commercialize NGS-based genetic testing assays and sequencing systems utilizing such assays, which incorporate the
Company’s proprietary technology. According to the terms of the agreement, the Company is initially entitled to receive
an upfront license fee and prepaid royalties totaling $40.0 million, which was fully collected in 2018. All or a portion of
the prepaid royalties are refundable in limited circumstances, including upon termination in certain circumstances. In
addition, the Company is entitled to potential milestone payments from Qiagen upon the successful achievement of certain
volume, regulatory and commercial milestones, and tiered royalties of $10.0 million, of which the Company has received
$5.0 million as of December 31, 2019. The Qiagen Agreement has a term of 10 years and expires in March 2028, and it
may be terminated earlier in certain circumstances. Upon termination of the Qiagen Agreement, the license granted to
Qiagen will also terminate, except in certain limited circumstances. The Company provided to Qiagen standard
indemnification protections, which is part of an assurance that the license meets the contract’s specifications and is not an
obligation to provide goods or services. Qiagen has announced that it has discontinued the development of its Next
Generation Sequencing Platform. The Company is in discussions with Qiagen regarding the resulting impact on the Qiagen
Agreement.
The Company identified the following goods and services in the agreement that it concluded were distinct
performance obligations:
Technology license. The Company granted the right to Qiagen to use its proprietary intellectual properties
(“technology license”) to develop, manufacture, distribute and commercialize genetic testing assays and sequencing
systems in certain countries. The technology license was transferred to Qiagen at the inception of this agreement when the
license became effective and the technology transfer was completed.
Development services. The Company is responsible for providing certain support services to assist Qiagen in its
design and development of the genetic testing assays.
Market development support. The Company is required to support Qiagen’s market development for the genetic
testing assays.
Option to expand commercialization to another country. The Company has provided an option to Qiagen to
expand the commercialization of its genetic testing assays to another country following all of the necessary regulatory
approvals.
The initial transaction price was primarily comprised of the upfront non-refundable fee and a payment associated
with the initial milestone under the agreement. The Company constrains the estimated variable consideration when it
assesses it is probable that a significant reversal in the amount of cumulative revenue recognized may occur in future
periods. The remaining milestone and prepaid royalty amounts were constrained and not included in the transaction price
due to the uncertainties of research and development and the potential for prepaid royalty refund. The Company re-
evaluates the transaction price, including the estimated variable consideration included in the transaction price and all
constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances
107
occur. The allocation of the transaction price was performed based on standalone selling prices, which are based on
estimated amounts that the Company would charge for a performance obligation if it were sold separately. Future variable
consideration such as milestones and royalties are considered associated with the technology license performance
obligation. The amounts included in the initial transaction price were allocated to the remaining value of the technology
license, as well as development services, market development support and the option to expand commercialization using
the relative standalone selling price approach. The amount initially allocated to the technology license was $5.5 million.
In accordance with ASC 340-40, any incremental costs incurred to obtain a contract with a customer are required
to be capitalized and amortized over the period in which the goods and services are transferred to the customer. The
Company has elected to apply a practical expedient under ASC 340-40 to recognize the incremental costs of obtaining a
contract as an expense when incurred provided that the amortization period of such costs, if capitalized, is one year or
less.
BGI Genomics
In February 2019, the Company entered into a License Agreement with BGI Genomics Co., Ltd. (“BGI
Genomics” or “BGI”) to develop, manufacture, and commercialize NGS-based genetic testing assays for clinical and
commercial use. The agreement has a term of ten years and expires in February 2029. According to the agreement, the
Company is entitled to a total of $50 million, comprised of upfront technology license fees, prepaid royalties relating to
future sales of licensed products and performance of assay interpretation services, and milestone payments. During the
three months ended June 30, 2019, the Company received $35.6 million, net of withholding taxes, of these amounts. The
Company recorded a receivable of $2.5 million upon achieving the first milestone as of June 30, 2019. Also, as required
by the agreement with BGI Genomics, in June 2019 the Company prepaid $6.0 million to BGI Genomics for future
sequencing services and $4.0 million for future sequencing equipment. These advance payments for equipment and
services to be received in future periods aggregating $10 million were recorded in long-term advances.
Pursuant to the agreement, the Company licensed its intellectual property and will provide development services.
Following completion of development services, the Company will provide assay interpretation services over the term of
the agreement. The Company concluded that the license is not a distinct performance obligation as it is highly interrelated
and interdependent with the related development services. Therefore, license and related development services, for each
of NIPT and Oncology products, represents a single performance obligation.
The Company is responsible for granting a license to specified intellectual property and performing certain
development activities to customize its genetic testing assays for oncology and NIPT for use with BGI Genomics’
sequencing instruments and proprietary technology platform. Revenue associated with these performance obligations is
recognized over time using the input method, based on costs incurred to perform the development services, since the level
of costs incurred over time best reflect the transfer of development services. Revenue associated with the assay
interpretation services will be recognized upon delivery of these services. Funds received in advance are recorded as
deferred revenue and will be recognized as the related services are delivered.
The initial transaction price was primarily comprised of license and milestone fees. The Company constrains the
estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative
revenue recognized may occur in future periods. Certain milestone and license fees were constrained and not included in
the transaction price due to the uncertainties of research and development. The Company re-evaluates the transaction price,
including the estimated variable consideration included in the transaction price and all constrained amounts, in each
reporting period and as uncertain events are resolved or other changes in circumstances occur. The allocation of the
transaction price was performed based on standalone selling prices, which are based on estimated amounts that the
Company would charge for a performance obligation if it were sold separately.
In accordance with ASC 340-40, any incremental costs incurred to obtain a contract with a customer are required
to be capitalized and amortized over the period in which the goods and services are transferred to the customer. The
Company has elected to apply a practical expedient under ASC 340-40 to recognize the incremental costs of obtaining a
contract as an expense when incurred provided that the amortization period of such costs, if capitalized, is one year or less.
The incremental costs incurred in connection with the BGI arrangement is not material on an accumulated basis and
therefore will not be capitalized on the balance sheet but will be expensed as incurred.
108
Foundation Medicine, Inc.
In August 2019, the Company entered into a License and Collaboration Agreement with Foundation Medicine,
Inc. (“Foundation Medicine” or “FMI”) to develop and commercialize personalized circulating tumor DNA monitoring
assays, for use by biopharmaceutical and clinical customers who order Foundation Medicine’s FoundationOne CDx. The
agreement has an initial term of five years, expiring in August 2024, with automatic renewals thereafter for successive
one-year terms. Natera and Foundation Medicine will share the revenues generated from both biopharmaceutical and
clinical customers. The agreement provides for approximately $13.3 million in upfront licensing fees and prepaid revenues
payable to Natera, and up to approximately $32.0 million in minimum annual payments and payments tied to Natera’s
achievement of certain developmental, regulatory, and commercial milestones. During the year ended December 31, 2019,
the Company received $16.3 million of these amounts, of which $3.0 million was for achieving development performance
milestones, and $13.3 million was for licensing fees and prepaid revenue.
Pursuant to the agreement, the Company will provide development services in conjunction with granting the use
of the Company’s intellectual property. Following completion of development services, the Company will provide assay
testing services over the term of the agreement. The Company concluded that the license is not a distinct performance
obligation as it is highly interrelated and interdependent with the related development services. Therefore, license and
related development services represents a single performance obligation.
The Company is responsible for providing the technology license and certain development services that are
required to customize its proprietary Signatera test to work with FMI’s FoundationOne CDX. The intellectual property
has been licensed to Foundation Medicine for the customized test. In addition, the Company is responsible for delivering
clinical study plans in order to demonstrate efficacy of the customized test. Revenues associated with each of the
performance obligations are recognized over time using the input method, based on costs incurred to perform the
development services, since the level of costs incurred over time best reflect the transfer of development services. Revenue
associated with the assay testing services will be recognized upon delivery of these services. Funds received in advance
are recorded as deferred revenue and will be recognized as the related services are delivered.
The initial transaction price was primarily comprised of license and milestone fees. The Company constrains the
estimated variable consideration when it assesses it is probable that a significant reversal in the amount of cumulative
revenue recognized may occur in future periods. Certain milestone fees were constrained and not included in the
transaction price due to the uncertainties of research and development. The Company re-evaluates the transaction price,
including the estimated variable consideration included in the transaction price and all constrained amounts, in each
reporting period and as uncertain events are resolved or other changes in circumstances occur. The allocation of the
transaction price was performed based on standalone selling prices, which are based on estimated amounts that the
Company would charge for a performance obligation if it were sold separately.
In accordance with ASC 340-40, any incremental costs incurred to obtain a contract with a customer are required
to be capitalized and amortized over the period in which the goods and services are transferred to the customer. The
Company has elected to apply a practical expedient under ASC 340-40 to recognize the incremental costs of obtaining a
contract as an expense when incurred provided that the amortization period of such costs, if capitalized, is one year or
less.
109
Disaggregation of Revenues
Our disaggregated revenues were as follows (in thousands):
2019
Year Ended December 31,
2018
2017
(Amounts in thousands)
Product revenues
Sale of genetic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
269,881 $
240,366 $
203,777
Licensing and other
Upfront license and Constellation and paternity . . . . . . . . . .
License and development services . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Licensing and other revenues . . . . . . . . . . . . . . . . . . . . . . .
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
5,089
16,379
10,979
32,447
302,328 $
10,344
294
6,650
17,288
257,654 $
4,229
—
1,619
5,848
209,625
The Company measures its performance results primarily based on revenues recognized from the three categories
described below. The following table shows disaggregation of revenues by payer types:
(Amounts in thousands)
Insurance carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Laboratory partners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
2019
Year Ended December 31,
2018
2017
210,919 $
59,876
31,533
302,328 $
193,895 $
44,062
19,697
257,654 $
163,861
36,001
9,763
209,625
110
The following table presents total revenues by geographic area based on the location of the Company’s payers:
(Amounts in thousands)
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Americas, excluding U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Europe, Middle East, India, Africa . . . . . . . . . . . . . . . . . . . . . . .
Asia Pacific and Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
Year ended December 31,
2019
2018
2017
260,846 $
3,218
15,434
22,830
302,328 $
225,931 $
3,472
20,866
7,385
257,654 $
185,533
3,028
13,998
7,066
209,625
The Company recognizes revenue from billings to insurance carriers and patients based on estimates of the
amount that will ultimately be realized (“expected consideration”). The expected consideration estimated for genetic test
services is based on many factors such as length of payer relationship, historical collection trends, changes in contract
provisions and insurance reimbursement policies. Cash collections for certain tests delivered may differ from the expected
consideration originally estimated. During the year ended December 31, 2019, the Company’s collections did not differ
significantly from original estimates of expected consideration. Thus, the Company did not recognize a cumulative catch-
up of revenue for the year ended December 31, 2019. However, for the year ended December 31, 2018, the original
estimates of expected consideration differed significantly from actual collections, and the updates of the Company’s
estimate resulted in a $10.2 million cumulative catch-up of revenue. These changes in estimates decreased the Company’s
loss from operations by $10.2 million and decreased basic and diluted net loss per share by approximately $0.18 for the
year ended December 31, 2018.
Contract Balances
The following table summarizes the Company’s beginning and ending balances of accounts receivable and
deferred revenues:
(Amounts in thousands)
Assets:
Balance at
December 31,
2019
Balance at
December 31,
2018
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
53,351 $
62,223
Liabilities:
Deferred revenue, current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Deferred revenue, long-term portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total deferred revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
56,016 $
23,808
79,824 $
4,131
40,058
44,189
The following table shows the changes in the balance of deferred revenues during the period:
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Increase in deferred revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revenue recognized during the period that was included in
deferred revenues at the beginning of the period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revenue recognized from performance obligations satisfied
within the same period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transferred in the sale of business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Deferred
Revenues
(in thousands)
44,189
65,026
(970)
(23,209)
(5,212)
79,824
111
During the year ended December 31, 2019, revenue recognized that was included in the deferred revenue balance
at the beginning of the period totaled $1.0 million, of which $0.5 million was related to genetic testing services and the
provision of IVD kits and $0.3 million pertained to undelivered Evercord storage services, and approximately $0.2 million
was related to the Qiagen Agreement.
As of December 31, 2019, total deferred revenues were $79.8 million were comprised of the current and long-
term portions of $56.0 million and $23.8 million, respectively. The current portion was primarily comprised of unsatisfied
performance obligations from our strategic partnership agreements of $55.3 million. The increase of $51.9 million in
current deferred revenues from $4.1 million in December 31, 2018 was primarily attributable to two new strategic
partnership agreements executed in the current year resulting in an additional $16.7 million of current deferred revenues
and the reclassification of long-term deferred revenues to current deferred revenues of $36.2 million due to the
discontinuance of Qiagen’s GeneReader NGS sequencing platform and the Company’s expectation to resolve contractual
obligations within the next 12 months. The long-term portion included $23.8 million of unsatisfied performance
obligations expected to be provided through the end of fiscal year 2021, resulting from two new strategic partnership
agreements executed in the current year of $23.8 million.
4. Fair Value Measurements
The Company's financial assets and liabilities carried at fair value are comprised of investment assets that include
money market and investments, and a liability for common stock warrants.
The fair value accounting guidance requires that assets and liabilities be carried at fair value and classified in one
of the following three categories:
Level I: Quoted prices in active markets for identical assets and liabilities that the Company has the ability to
access.
Level II: Observable market-based inputs or unobservable inputs that are corroborated by market data, such as
quoted prices, interest rates, and yield curves.
Level III: Inputs that are unobservable data points that are not corroborated by market data.
This hierarchy requires the Company to use observable market data, when available, and to minimize the use of
unobservable inputs when determining fair value. There were no transfers between Level I, Level II and Level III during
the periods presented.
Assets and Liabilities That Are Measured at Fair Value on a Recurring Basis
The following table represents the fair value hierarchy for the Company’s financial assets and financial liabilities
measured at fair value on a recurring basis:
Level I
Level II Level III Total
Level I
December 31, 2019
December 31, 2018
Level II Level III
Total
(in thousands)
Financial Assets:
Money market deposits. . $ 22,477 $
U.S. Treasury securities .
U.S. agency securities . . .
Municipal securities . . . .
293,157
—
—
— $
—
—
85,908
Total financial assets . . . . . $ 315,634 $ 85,908 $
— $ 22,477 $ 26,539 $
—
—
—
— $ 401,542 $ 102,224 $ 31,776 $
— $
—
12,891
18,885
293,157
—
85,908
75,685
—
—
— $ 26,539
75,685
—
—
12,891
18,885
—
— $ 134,000
112
During the year ended December 31, 2019, the Company did not make any transfers between Level I and Level
II assets.
5. Financial Instruments
The Company elected to invest a portion of its cash assets in conservative, income earning, liquid investments.
Cash equivalents and investments, all of which are classified as available-for-sale securities, consisted of the following:
December 31, 2019
Gross
Unrealized
Gain
Gross
Unrealized
(Loss)
Amortized
Cost
Estimated Fair
Value
Amortized
Cost
(in thousands)
December 31, 2018
Gross
Unrealized
Gain
Gross
Unrealized
(Loss)
Estimated Fair
Value
Money market deposits. . . $ 22,477 $
U.S. Treasury securities . . 292,506
—
U.S. agency securities . . . .
Municipal securities . . . . .
85,638
Total . . . . . . . . . . . . . . . . . . $ 400,621 $ 1,008 $
— $
731
—
277
— $
(80)
—
(7)
(87) $
22,477 $ 26,539 $
293,157 76,061
— 13,017
18,935
85,908
401,542 $ 134,552 $
— $
29
—
7
36 $
— $
(405)
(126)
(57)
(588) $
26,539
75,685
12,891
18,885
134,000
Classified as:
Cash equivalents . . . . . . .
Short-term investments .
Total . . . . . . . . . . . . . . . . . .
$
$
22,477
379,065
401,542
$
$
26,539
107,461
134,000
The Company invests in U.S. Treasuries, U.S. agency and high-quality municipal bonds which mature at par and
are all paying their coupons on schedule. Thus, the Company has determined there is currently no other than temporary
impairment of its investments and will continue to recognize unrealized losses in other comprehensive income. As of
December 31, 2019, the Company has 8 investments in an unrealized loss position in its portfolio. During the years ended
December 31, 2019, 2018, and 2017 the amount of gross realized gains and realized losses upon sales of investments were
insignificant. Realized gains and losses are reported in interest and other (expense) income, net in the statements of
operations and comprehensive loss. The following table shows the change in the net unrealized positions of the available-
for-sale securities and reclassifications from accumulated other comprehensive loss upon the sale of those securities:
Balance at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net unrealized gains (losses) on available-for-sale securities, net of tax . . . . . . . . . . . . .
Reclassifications of losses (gains) realized from sale of available-for-sale securities . .
Increase (decrease) in other comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2019
2018
$
(in thousands)
(552) $
1,487
(16)
1,471
$
919 $
(766)
171
43
214
(552)
During the years ended December 31, 2019, 2018 and 2017, the Company earned interest income of $4.1 million,
$1.8 million and $1.2 million, respectively, from its investment portfolio.
113
The following table summarizes the Company’s portfolio of available-for-sale securities by contractual maturity
as of December 31, 2019:
Less than one year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Greater than one year but less than five years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
141,380 $ 141,552
236,764
237,513
378,144 $ 379,065
December 31, 2019
Amortized
Cost
Fair
Value
(in thousands)
6. Balance Sheet Components
Allowance for Doubtful Accounts
The following table presents a reconciliation of the allowance for doubtful accounts:
Beginning balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Provision for estimated bad debts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Write offs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ending balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
1,788 $
1,141
(10)
2,919 $
2,000 $
(41)
(171)
1,788 $
1,890
143
(33)
2,000
December 31, December 31, December 31,
2019
2018
(in thousands)
2017
Property and Equipment, net
The Company’s property and equipment consisted of the following:
Useful Life
2019
2018
December 31, December 31,
Machinery and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Furniture and fixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Computer equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capitalized software held for internal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Life of lease
Construction-in-process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3-5 years $
3 years
3 years
3 years
Less: Accumulated depreciation and amortization . . . . . . . . . . . . . . . . . . . . . .
Total Property and Equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
(in thousands)
36,414 $
1,376
1,828
5,917
11,556
7,716
64,807
(41,524)
23,283 $
35,400
1,319
2,117
4,868
10,916
4,013
58,633
(34,297)
24,336
All of the Company’s long-lived assets are located in the United States.
During the year ended December 31, 2019, an impairment charge of $1.7 million was recorded in selling, general,
and administrative expenses in the consolidated statement of operations and comprehensive loss. This charge is comprised
of $1.2 million from the impairment of leasehold improvements, $0.1 million from the impairment of capitalized software
held for internal use, and $0.4 million from the right-of-use asset (Note 7, Leases) related to the disposal of business (Note
13, Disposal of Business). The right-of-use asset and the leasehold improvements relate to the storage facility located in
Tukwila, Washington, and both assets were evaluated for impairment as a single asset group. Subsequent to the sale of
Evercord, the impairment charge wrote off the leasehold improvements that was previously capitalized for the storage
facility and wrote down the right-of-use asset to its fair value as of the sale date. The impairment charge to capitalized
114
software relate to an internally developed module that was solely used for the Evercord business and scrapped subsequent
to the sale of Evercord.
During the year ended December 31, 2018, an asset impairment charge of $1.5 million was recorded in research
and development expenses in the statements of operations and comprehensive loss. This charge was recorded to write off
certain project development costs that were previously capitalized.
Other Assets
In August 2017, the Company entered into the 2017 Term Loan with OrbiMed (as described in Note 10) and
issued 300,000 shares of its common stock in exchange for OrbiMed’s initial and remaining funding commitments. In
April 2019, the Company issued an additional 25,000 shares of its common stock to OrbiMed for extending the expiration
date to draw the unused borrowing capacity until December 31, 2019. The Company has classified $1.2 million out of the
total debt issuance costs in noncurrent assets for the unused borrowing capacity of $50.0 million. The debt discount is
being amortized on a straight-line basis over the remaining term of the loan. For the year ended December 31, 2019 and
2018, debt discount amortized from noncurrent assets was $0.2 million and $0.1 million, respectively. The debt discount
amortized from noncurrent assets for the year ended December 31, 2017 was not significant. As of December 31, 2019,
total unamortized remaining in noncurrent assets was $0.9 million.
As of December 31, 2019, other assets also included long-term advances to BGI of $10.0 million for future
sequencing equipment and services. In addition, other assets include additional consideration of consideration estimated
at $4.7 million in connection with the disposal of business (Note 13). It is primarily related to the accounts receivable
transferred to the buyer.
Accrued Compensation
The Company’s accrued compensation consisted of the following:
Accrued paid time off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Accrued commissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued bonuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
1,850 $
5,767
5,710
2,761
16,088 $
1,825
4,492
3,757
2,594
12,668
December 31, December 31,
2019
2018
(in thousands)
115
Other Accrued Liabilities
The Company’s other accrued liabilities consisted of the following:
December 31, December 31,
2019
2018
(Amounts in thousands)
Settlement accrued for reimbursement related claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Reserves for refunds to insurance carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued charges for outsourced testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Testing and laboratory materials from suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketing and corporate affairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Legal, audit and consulting fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued shipping charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sales tax payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued specimen service fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued rent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical trials and studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities, current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fixed asset purchases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total other accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
— $
9,410
8,408
4,301
2,957
2,873
305
1,691
2,269
—
1,092
5,739
1,482
8,516
49,043 $
1,378
10,012
5,001
2,742
1,306
1,058
852
1,255
1,378
903
1,694
—
—
4,863
32,442
Reserves for refunds to insurance carriers include overpayments from and amounts to be refunded to insurance
carriers, and additional amounts that the Company estimates for potential refund requests during the period. When the
Company releases these previously accrued amounts, they are recognized as product revenues in the statements of
operations and comprehensive loss.
The following table summarizes the reserve balance and activities for refunds to insurance carriers (in thousands):
December 31, December 31,
2019
2018
(Amounts in thousands)
Beginning balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Additional reserves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reserves released . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ending balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
10,012 $
9,560
(10,162)
9,410 $
6,795
10,295
(7,078)
10,012
Released into revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
2,410 $
3,324
7. Leases
Operating Leases
In October 2016, the Company entered into a lease directly with its landlord for laboratory and office spaces at
its corporate headquarters located in San Carlos, California. The Company currently occupies approximately 136,000
square feet comprised of two office spaces (the “First Space” and the “Second Space”). The First Space covers
approximately 88,000 square feet, and the Second Space totals approximately 48,000 square feet. The term of this lease is
approximately 84 months and expires in October 2023. This lease contains an option to renew the lease term for five years,
but the fair market rent amount upon renewal is not available from the landlord.
116
In addition, the Company entered into a sublease agreement in June 2019 with a third party to sublease 25,879
square feet of space located on the third floor of the San Carlos, California building while maintaining its primary
obligation as the intermediate lessor. The term of this lease is approximately 48 months commencing in October 2019 and
expiring in September 2023. The yearly lease payment starts at $1.9 million and will escalate annually starting in
October 2020.
In March 2018, the Company entered into a lease for its cord blood tissue storage facility in Tukwila, Washington
that covers approximately 10,000 square feet. The lease term of this facility began in June 2018 with rent payment
commencing in August 2018. The lease term is 62 months expiring in July 2023. The Company has the option to extend
this lease for five years, and the fair market rent upon renewal is not determinable. However, since the Company sold its
business related to cord blood and tissue storage in September 2019, it is expected the Company will sublet the facility
and will not exercise its option to renew the facility upon expiration.
In September 2015, the Company’s subsidiary entered into a long-term lease agreement for laboratory and office
space totaling approximately 94,000 square feet in Austin, Texas. The lease term is 132 months beginning in
December 2015 and expiring in November 2026 with monthly payments beginning in December 2016.
As a result of electing the package of practical expedients, the Company did not reassess the classification for the
three existing leases described above upon the adoption of ASC 842, which carried over as operating leases. These leases
are not impacted by any renewal or termination option. In addition, the Company has also entered into leases of individual
workspaces at premises located in different locations on a month-to-month basis and is not committed to an established
lease term. The Company has elected to not recognize them as the right-of-use assets on the balance sheet as they are all
considered as short-term leases. Short-term lease expenses were insignificant in the year ended December 31, 2019.
The operating lease right-of-use assets are classified as noncurrent assets in the balance sheet. The corresponding
lease liabilities are separated into current and long-term portions as follows:
December 31,
2019
(in thousands)
Operating lease liabilities, current portion included in other accrued liabilities . . . . . . . . . . . . . . . . . . . $
Operating lease liabilities, long-term portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total operating lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
5,739
26,297
32,036
The initial recognition of the operating lease liabilities was measured as the present value of the future minimum
lease payments using a discount rate determined as of January 1, 2019. The operating right-of-use assets was calculated
as the operating lease liabilities discounted at the present value, less the amount of unamortized tenant improvement
allowance and deferred rent. The discount rate used was the Company’s incremental borrowing rate given that the implicit
rate to each lease was not readily determinable. As of the adoption date, the incremental borrowing rate was estimated as
the annual percentage yield resulting from a corporate debt financing over a loan term approximating the remaining term
of each lease, with the effect of certain credit risk rating. As of December 31, 2019, the weighted-average remaining lease
term was 3.04 years and the weighted-average discount rate was 10.77%.
Subsequent to the adoption date, the Company continues to recognize lease expense on a straight-line basis as
was required under the previous guidance, ASC 840. The lease expense includes the amortization of the right-of-assets
with the associated interest component estimated by applying the effective interest method. For the year ended
December 31, 2019, total lease expense of $7.8 million was recognized in the statements of operations and comprehensive
loss. In addition, the Company recorded an impairment expense of $0.4 million in selling general and administrative
expenses for the right-of-use asset related to the storage facility lease in connection with the disposal of business in the
year ended December 31, 2019 (Note 13). Cash paid for amounts in the measurement of operating lease liabilities totaled
$8.6 million for the year ended December 31, 2019.
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The future annual minimum lease payments under all non-cancelable operating leases as of December 31, 2019
are as follows:
Year ending December 31:
Operating Leases
(in thousands)
2020 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2021 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2025 and thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total future minimum lease payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less: imputed interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
8,825
9,067
9,319
7,797
2,400
4,730
42,138
(10,102)
32,036
As of December 31, 2018, prior to the adoption of Topic 842, annual future minimum payments of our operating
leases were as follows:
Year ending December 31:
Operating Leases
(in thousands)
2019 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2020 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2021 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 and thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total future minimum lease payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
8,588
8,825
9,067
9,319
7,702
7,130
50,631
Rent expense for the years ended December 31, 2019, 2018 and 2017 was $7.8 million, $7.4 million and $7.2
million, respectively. Several lease arrangements contain provisions for variable lease payments relating to utilities and
maintenance costs. Variable lease payments are expensed in the period in which the obligation for those payments is
incurred and excluded from the calculation of lease liabilities and right-of-use assets.
8. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is involved in disputes, litigation, and other legal actions. The Company is
aggressively defending and/or prosecuting its current litigation matters, but cannot provide any assurance as to the ultimate
outcome or that an adverse resolution would not have a material adverse effect on its financial condition and results of
operations. There are many uncertainties associated with any litigation and these actions or other third party claims against
the Company, or by the Company against third parties, may cause the Company to incur costly litigation and/or substantial
settlement charges. In addition, the resolution of any intellectual property litigation may require the Company to make
royalty payments, which could adversely affect gross margins in future periods. If this were to occur, the Company's
business, financial condition, results of operations, and cash flows could be adversely affected.
The Company assesses legal contingencies to determine the degree of probability and range of possible loss for
potential accrual in its financial statements. When evaluating legal contingencies, the Company may be unable to provide
a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence
of complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters.
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In addition, damage amounts claimed in litigation against it may be unsupported, exaggerated or unrelated to possible
outcomes, and as such are not meaningful indicators of its potential liability. During the periods presented, the Company
has not recorded any accrual for loss contingencies associated with such legal proceedings, determined that an unfavorable
outcome is probable or reasonably possible, or determined that the amount or range of any possible loss is reasonably
estimable.
Illumina Litigation.
On March 16, 2018, a lawsuit (the ’831 lawsuit) against the Company was filed in the United States District
Court for the Northern District of California by Illumina, Inc., or Illumina, alleging that the Company’s Panorama test
infringes certain claims of U.S. Patent No. 9,493,831 (the ’831 patent). Among other relief, the complaint seeks damages
or other monetary relief including costs and pre- and post-judgment interest, treble damages, injunctive relief, attorneys’
fees and costs. On August 16, 2018, the Company filed a counterclaim against Illumina, alleging that certain of
Illumina’s NIPT tests infringe on the Company’s U.S. Patent No. 8,682,592 (the ’592 patent). Among other relief,
Natera seeks damages or other monetary relief including costs and pre- and post-judgment interest, treble damages,
injunctive relief, attorneys’ fees and costs. On June 13, 2019, Illumina filed a petition for inter partes review of the ’592
patent, which petition has been instituted. The ‘831 lawsuit is currently scheduled for trial on June 22, 2020.
CareDX Litigation Matters.
On March 26, 2019, CareDX, Inc., or CareDX, filed suit against the Company in the United States District
Court for the District of Delaware (“CareDX’s Patent Case”). The suit alleges that the Company infringed two of
CareDX’s patents, 9,845,497 and 8,703,652. The complaint seeks unspecified damages and injunctive relief. On May 16,
2019, the Company filed a motion to dismiss CareDX’s Patent Case for failure to state a claim, and a hearing on the
motion took place on November 21, 2019. On February 24, 2020, Natera filed an objection to a preliminary
recommendation by the magistrate judge that Natera’s motion to dismiss be denied.
In addition, on April 10, 2019, CareDX filed suit against the Company in the United States District Court for
the District of Delaware, alleging false advertising, trademark disparagement, unfair competition, and unfair or deceptive
trade practices based on statements describing studies that concern the Company’s technology and CareDX’s technology
(“CareDX’s Advertising Case”). The complaint seeks unspecified damages and injunctive relief. On May 30, 2019, the
Company filed a motion to dismiss the entirety of CareDX’s Advertising Case for failure to state a claim. On February 7,
2020, CareDx filed an amended complaint withdrawing its trademark disparagement claim. On February 18, 2020, the
Company filed a counterclaim against CareDX in the United States District Court for the District of Delaware, alleging
false advertising, unfair competition and deceptive trade practices and seeking unspecified damages and injunctive relief.
On or about January 13, 2020, the Company filed suit against CareDX in the United States District Court for
the District of Delaware (“Natera’s Patent Case”), alleging infringement of the Company’s U.S. Patent No. 10,526,658
(the ’658 patent) covering cell-free DNA-based diagnostic methods for transplant. The complaint seeks unspecified
damages and injunctive relief. Natera’s Patent Case has been consolidated with CareDx’s Patent Case.
Other Litigation Matters.
On or about January 27, 2020, the Company filed suit against ArcherDX, Inc., or ArcherDX, in the United
States District Court for the District of Delaware, alleging that certain of ArcherDX’s DNA oncology products infringe
on the Company’s U.S. Patent No. 10,538,814 (the ’814 patent). The complaint seeks monetary damages and injunctive
relief.
On or about August 13, 2019, a suit was filed against the Company in the Circuit Court of Cook County,
Illinois by a patient alleging claims relating to a discordant test result and seeking monetary damages.
On March 15, 2019, a purported class action lawsuit was filed against the Company in the United States District
Court for the Northern District of California, alleging that the plaintiff received an unauthorized text message to her
119
cellular telephone in violation of the Telephone Consumer Protection Act. Among other relief, the complaint seeks
statutory and other damages, injunctive relief, attorneys’ fees, and costs. On June 18, 2019, the Company filed a motion
to dismiss, which was denied.
On each of February 17, 2016, March 10, 2016, March 28, 2016 and April 4, 2016, purported class action
lawsuits were filed in the Superior Court of the State of California for the County of San Mateo (the “San Mateo
Superior Court”), against Natera, its directors, certain of its officers and 5% stockholders and their affiliates, and each of
the underwriters of the Company’s July 1, 2015 initial public offering (the “IPO”). The complaints asserted claims under
Sections 11, 12(a)(2) and 15 of the Securities Act of 1933, as amended. The complaints alleged, among other things, that
the Registration Statement and Prospectus for the Company’s IPO contained materially false or misleading statements,
and/or omitted material information that was required to be disclosed, about the Company’s business and prospects.
Among other relief, the complaints sought class certification, unspecified compensatory damages, rescission, attorneys'
fees, and costs. On October 23, 2017, the San Mateo Superior Court granted the Company’s motion to dismiss the claims
under Sections 12(a)(2) and 15 of the Securities Act of 1933, as amended, without leave to re-file, and granted the
Company’s motion to dismiss the claims under Section 11 of the Act with leave to re-file. Plaintiffs refiled an amended
complaint on November 22, 2017. On August 7, 2018 the judge granted a motion by the Company for judgment on the
pleadings, without leave to amend, and ordered that judgment be entered in favor of the defendants. Plaintiffs appealed
the judgment on or about March 29, 2019, and the appeal was heard on February 18, 2020. On February 28, 2020, the
Court of Appeal for the State of California affirmed the judgment on the pleadings in favor of Natera.
Director and Officer Indemnifications
As permitted under Delaware law, and as set forth in the Company’s Certificate of Incorporation and its Bylaws,
the Company indemnifies its directors, executive officers, other officers, employees and other agents for certain events or
occurrences that may arise while in such capacity. The maximum potential amount of future payments the Company could
be required to make under this indemnification is unlimited; however, the Company has insurance policies that may limit
its exposure and may enable it to recover a portion of any future amounts paid. Assuming the applicability of coverage,
the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions,
the Company believes any obligations under this indemnification would not be material, other than an initial $1.5 million
for securities related claims an $0.3 million for commercial general liability claims. However, no assurances can be given
that the covering insurers will not attempt to dispute the validity, applicability, or amount of coverage without expensive
litigation against these insurers, in which case the Company may incur substantial liabilities as a result of these
indemnification obligations.
Third-Party Payer Reimbursement Audits
From time to time, the Company receives recoupment requests from third-party payers for alleged overpayments.
The Company disagrees with the contentions of pending requests and/or has recorded an estimated reserve for the alleged
overpayments. The Company is unable to predict the outcome and is unable to make a meaningful estimate of the amount
or range of loss, if any, that could result from any unfavorable outcome, and/or amounts recorded as an estimated reserve
for the alleged overpayments is not material.
Contractual Commitments
The following table sets forth the material contractual commitments as of December 31, 2019:
Party
Laboratory instruments supplier . . . . . . . . . . . . . . . . . . . . . . . . .
Material supplier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application service provider . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gene sequencing reagents and kits provider . . . . . . . . . . . . . . .
Specimen samples provider . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Biological sample processing and storage provider . . . . . . . . .
Other material supplier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
Total Commitments
(in thousands)
10,679
8,495
1,964
1,148
300
250
6,598
Expiry Date
December 2021
January 2020
September 2023
April 2021
April 2020
September 2020
Various dates
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9. Stock-Based Compensation
Equity Plans
2015 Equity Incentive Plan
General. The Company’s board of directors adopted its 2015 Equity Incentive Plan, or the 2015 Plan, in
June 2015. The Company’s 2015 Plan replaced all of its prior stock plans.
Share Reserve. The initial number of shares of the Company’s common stock available for issuance under the
2015 Plan was 3,451,495 shares. As of December 31, 2019, 14,062,396 shares were reserved for future issuance under the
2015 plan, which includes unissued and forfeited shares from the 2007 plan. The number of shares reserved for issuance
under the 2015 Plan will be increased automatically on the first business day of each fiscal year, commencing in 2016, by
a number equal to the smallest of:
•
•
•
3,500,000 shares;
4% of the shares of common stock outstanding on the last business day of the prior fiscal year; or
the number of shares determined by the Company’s board of directors.
Stock options vest as determined by the compensation committee. In general, they will vest over a four-year
period following the date of grant. Stock options expire at the time determined by the compensation committee but in no
event more than ten years after they are granted. These awards generally expire earlier if the participant's service terminates
earlier.
Restricted Shares and Stock Units. Restricted shares and stock units may be awarded under the 2015 Plan in
return for any lawful consideration, and participant who receive restricted shares or stock units generally are not required
to pay cash for their awards. In general, these awards will be subject to vesting. Vesting may be based on length of service,
the attainment of performance-based milestones or a combination of both, as determined by the compensation committee.
2015 Employee Stock Purchase Plan
General. The Company’s 2015 Employee Stock Purchase Plan, or 2015 ESPP, was adopted by its board of
directors in June 2015 and its stockholders approved it in June 2015. The 2015 ESPP is intended to qualify under Section
423 of the Internal Revenue Code.
Share Reserve. The Company has reserved 893,548 shares of its common stock for issuance under the 2015
ESPP. As of December 31, 2019, 1,638,280 shares were available for issuance under the 2015 ESPP. The number of shares
reserved for issuance under the 2015 ESPP will automatically be increased on the first business day of each of the
Company’s fiscal years, commencing in 2016, by a number equal to the least of:
•
•
•
880,000 shares;
1% of the shares of common stock outstanding on the last business day of the prior fiscal year; or
the number of shares determined by the Company’s board of directors.
The number of shares reserved under the 2015 ESPP will automatically be adjusted in the event of a stock split,
stock dividend or a reverse stock split (including an adjustment to the per-purchase period share limit).
121
Purchase Price. Employees may purchase each share of common stock under the 2015 ESPP at a price equal
to 85% of the lower of the fair market values of the stock as of the beginning or the end of the six-month offering periods.
An employee’s payroll deductions under the ESPP are limited to 15% of the compensation, and up to a maximum of 5,000
shares may be purchased during any offering period. A participant shall not be granted an option under the ESPP if such
option would permit the participant’s rights to purchase stock to accrue at a rate exceeding $25,000 fair market value of
stock for each calendar year in which such option is outstanding at any time.
Offering Periods. Each offering period will last a number of months determined by the compensation committee,
not to exceed 27 months. A new offering period will begin periodically, as determined by the compensation committee.
Offering periods may overlap or may be consecutive. Unless otherwise determined by the compensation committee, two
offering periods of six months' duration will begin in each year on May 1 and November 1.
The following table summarizes the offering activity during the years ended December 31, 2019 and 2018:
Offering Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
November 1, 2017 - April 30, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
May 1, 2018 - October 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
November 1, 2018 - April 30, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
May 1, 2019 - October 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock Options
Number of
Shares Purchased
Total
Proceeds
(in thousands)
206,447 $
184,825 $
132,177 $
136,084 $
1,855
1,763
2,147
2,176
The following table summarizes option activity during the year ended December 31, 2019:
Outstanding Options
Weighted-
Average Remaining
Available for Number of Exercise Contractual
Shares
Weighted-
Average
(in thousands, except for contractual life and exercise price)
Grant
Shares
Price
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . .
Additional shares authorized . . . . . . . . . . . . . . . . . . .
Options granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Options exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Options forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . .
Exercisable at December 31, 2019 . . . . . . . . . . . . . . . . .
Vested and expected to vest at December 31, 2019 . . .
5,431
2,483
(1,838)
—
340
6,416
9,463 $
7.69
— $ —
1,838 $ 18.01
5.29
(2,464) $
(340) $ 13.13
8,497 $ 10.39
7.27
4,835 $
8,288 $ 10.29
Aggregate
Intrinsic
Value
61,718
Life
(In years)
6.91
$
6.88
5.56
6.83
$ 197,955
$ 127,753
$ 193,940
The total intrinsic value of stock options exercised during the years ended December 31, 2019, 2018 and 2017
was $70.0 million, $25.6 million and $3.7 million, respectively. The total fair value of stock options vested during the
years ended December 31, 2019, 2018 and 2017 was $11.0 million, $11.3 million, and $12.1 million, respectively.
The weighted-average grant date fair value of options granted during the years ended December 31, 2019, 2018
and 2017 was $8.01, $4.85 and $5.71 per share, respectively.
Performance-based Awards
In June 2017, the Board approved a stock option grant of 425,000 shares to the Company’s executive chairman,
of which 200,000 shares are performance-based options. The vesting of these performance-based options is contingent
122
upon the completion of requisite service for the next three years and the achievement of certain milestones within such
time period. The milestones are (i) to successfully secure a specified strategic arrangement, at which point 50,000 shares
will begin vesting over one year in equal quarterly installments, (ii) to successfully secure a specified licensing
arrangement, at which point 75,000 shares will begin vesting over one year in equal quarterly installments, and (iii) to
successfully secure specified licensing arrangements related to oncology, at which point 75,000 shares will begin vesting
over one year in equal quarterly installments. Each milestone is independent of the other.
Milestones (i) and (ii) described above were achieved during the first quarter of 2019 and 2018, respectively.
Milestone (iii) described above was achieved during the third quarter of 2019. During the year ended December 31, 2019
and 2018 total stock-based compensation expense recorded for the performance-based options was $0.6 million, $0.4
million, respectively. For the year ended December 31, 2017, the Company did not recognize any compensation expense
associated with the performance-based options since none of the milestones were achieved or were probable of being
achieved.
In December 2018, the Board approved a performance-based option grant of 600,000 shares to the Company’s
executive chairman. The vesting of these performance-based options is contingent upon the achievement of a certain
milestone, and provided that the completion of requisite service is through the date of such vesting, at which point the
performance-based options will become fully vested and exercisable. The revenue milestone was concluded to be probable
of being achieved in the third quarter of 2019, and the Company recognized $3.3 million of stock-based compensation
expense in the year ended December 31, 2019.
In January 2019, the Board approved a stock option grant of 200,000 shares and 100,000 restricted stock units to
the Company’s chief executive officer, which are performance-based awards with market conditions. Such awards will
vest based on the achievement of certain values of the Company’s common stock at two separate thresholds within certain
periods and are contingent upon the completion of requisite service through the date of such vesting. The Company utilized
a Monte Carlo Simulation to determine the grant date fair value of such awards and the period when such award will
become probable. The first milestone was achieved in the third quarter of 2019, resulting in 18,750 of restricted stock units
and 37,500 stock options to vest. For the year ended December 31, 2019 the Company recorded approximately $0.6 million
of stock-based compensation related to such awards.
Additionally, the Board approved 100,000 restricted stock units each to the Company’s chief financial officer and
chief operating officer in March 2019. These two awards also have performance and market conditions, which are based
on the same stock value performance target as that of the chief executive officer’s before such awards vest and are
contingent upon the completion of requisite service through the date of such vesting. The Company utilized a Monte Carlo
Simulation to determine the grant date fair value of such awards and the period when such award will become probable.
The first milestone was achieved in the third quarter of 2019, resulting in 25,000 of restricted stock units to vest for each
individual. For the year ended December 31, 2019, the Company recorded approximately $1.2 million of stock-based
compensation related to such awards.
In May 2019, the Board approved a grant of 188,099 restricted stock units to several employees, which are
performance-based awards. Such awards will vest based on the achievement of a certain product line revenues over a
calendar year. The other performance target requires the achievement of a certain run rate for tests in another product line
and are contingent upon the completion of requisite service through the date of such vesting. The revenue milestone was
probable of being achieved in the third quarter of 2019. The Company recorded approximately $1.3 million of stock-based
compensation related to such awards year ended December 31, 2019.
In September 2019, the Board approved a grant of 50,000 restricted stock units to the Chief Business Officer.
Such awards will vest based on the achievement of certain values of the Company’s common stock at a specific
threshold within certain periods and are contingent upon the completion of requisite service through the date of such
vesting. The Company utilized a Monte Carlo Simulation to determine the grant date fair value of such awards and the
period when such award will become probable. For the year ended December 31, 2019, the Company recorded
approximately $0.3 million of stock-based compensation related to such awards.
123
The fair value of the performance-based awards with market conditions granted estimated using a Monte Carlo
simulation model used the following inputs for the year ended December 31, 2019:
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected volatility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected term (years) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2019
1.63% – 2.61%
—
50.00%
7.25
The risk-free interest rate input was based on U.S. Treasury note yields with remaining terms comparable to the
expected term input used in the valuation model. The expected dividend yield was selected to be zero as the vesting
condition is based on total shareholder return, which includes changes in price, plus reinvestment of dividends paid. The
expected volatility was based on historical daily price changes for a period of time that corresponds with the expected term
input used in the valuation model. The expected term input was based on the contractual remaining period of time until
the award vests in accordance with the award agreement.
Restricted Stock Units
The following table summarizes restricted stock unit activity for the year ended December 31, 2019:
Number of
Shares
Weighted-
Average
Grant Date
Fair Value
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Canceled/Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,084 $
2,019 $
(541) $
(158) $
2,404 $
11.72
20.97
12.56
16.68
19.86
Stock-Based Compensation Expense
Employee and non-employee stock-based compensation expense was calculated based on awards ultimately
expected to vest and have been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised,
if necessary, in subsequent periods, if actual forfeitures differ from those estimates.
The following table presents the effect of employee and non-employee stock-based compensation expense on
selected statements of operations line items for the years ended December 31, 2019, 2018 and 2017.
2019
Year ended December 31,
2018
2017
Employee Non-Employee Total
Employee Non-Employee Total
Employee Non-Employee Total
Cost of revenues . . . . . $
Research and
905 $
32 `
937 $
564 $
5 $
569 $
544 $
— $
544
(in thousands)
development . . . . . . .
5,354
—
5,354
4,043
—
4,043
3,214
—
3,214
Selling, general and
administrative . . . . . . 21,730
Total . . . . . . . . . . . . . . $ 27,989 $
603 22,333
9,474
635 $ 28,624 $ 14,081 $
9,586
112
7,644
117 $ 14,198 $ 11,402 $
—
7,644
— $ 11,402
124
As of December 31, 2019, approximately $50.2 million of unrecognized compensation expense related to
unvested option awards and RSUs, net of estimated forfeitures. The unrecognized compensation expense will be
recognized over a weighted-average period of approximately 2.86 years.
Valuation of Stock Option Grants to Employees and Non-Employees
Upon the adoption of ASU 2018-07 on January 1, 2019, the fair value of stock options granted to both employees
and non-employees is estimated on the grant date using the Black-Scholes option-pricing model except for the
performance-based options with a market condition. Prior to January 1, 2019, the Company only estimated the fair value
of the stock options granted to its employees on the grant date, while the fair value of its unvested non-employee stock
options was remeasured at the end of each reporting period up until their vesting date. The fair value of the stock options
is amortized on a straight‑line basis over the requisite service period of the awards, which is generally the vesting period.
The Company utilizes Black-Scholes option pricing model when estimating the fair value of stock options. For
the year ended December 31, 2019 the following valuation assumptions were applied on both the employee and non-
employee options. For the years ended December 31, 2018 and 2017, the valuation assumptions as follows were only used
for stock options granted to employees.
2017
Expected term (years) . . . . . . . . . . . . . . . . . . . . . . . . .
5.14 — 5.24
Expected volatility. . . . . . . . . . . . . . . . . . . . . . . . . . . . 42.53% — 45.84% 40.28% — 42.53 % 40.75 %— 62.93%
0 %
Expected dividend rate . . . . . . . . . . . . . . . . . . . . . . . .
2.37 % — 3.06 % 1.67 %— 2.16 %
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . .
0 %
1.60 % — 2.60 %
2019
5.23 — 10.00
0 %
Year ended December 31,
2018
5.24 — 5.62
For the years ended December 31, 2018 and 2017, the Company used a different set of Black-Scholes valuation
assumptions when estimating the fair value of stock options granted to its non-employees. The fair value was remeasured
at the end of each reporting period up until December 31, 2018. The following table summarizes the valuation assumptions
used:
Expected term (years) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected volatility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year ended December 31,
2018
2.72 — 2.76
41.36 % — 43.84 %
0 %
2.36 % — 2.86 %
2017
2.67 — 2.71
41.22 % — 52.18 %
0 %
1.42 % — 1.95 %
Expected Term: The expected term of options represents the period of time that options are expected to be
outstanding. The Company determines its expected term by calculating the average of—(1) its employees’ historical stock
options exercise behavior, and (2) the weighted-average of the time-to-vesting and the total contractual life of the options.
For employee stock options that are not granted "at-the-money," the Company uses the binomial lattice model to calculate
the expected term. Regarding non-employee stock options, the Company estimated the expected term by assessing their
historical exercise behavior and length of service, and calculated the average of these two components.
Expected Volatility: The Company derived the expected volatility from the average historical volatilities of
comparable publicly traded companies within its peer group over a period approximately equal to the expected term.
Expected Dividend Rate: The Company has not paid and does not anticipate paying any dividends in the near
future.
Risk-Free Interest Rate: The risk-free interest rate assumption is based on U.S. Treasury yield in effect at the
time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term.
125
10. Debt
Credit Line Agreement
In September 2015, the Company entered into a credit line with UBS (the “Credit Line”) providing for a $50.0
million revolving line of credit which can be drawn down in increments at any time. The Credit Line was amended in
July 2017 and bears interest at 30-day LIBOR plus 1.10%, and it is secured by a first priority lien and security interest in
the Company’s money market and marketable securities held in its managed investment account with UBS. UBS has the
right to demand full or partial payment of the Credit Line Obligations and terminate the Credit Line, in its discretion and
without cause, at any time.
For the years ended December 31, 2019, 2018 and 2017, the Company recorded interest expense of $1.7 million,
$1.6 million and $1.0 million, respectively. Interest payments totaling $1.7 million, $1.5 million, and $0.5 million had
been made on the Credit Line during the years ended December 31, 2019, 2018, and 2017, respectively. As of December 31,
2019, remaining accrued interest was $1.1 million, and the total principal amount outstanding including accrued interest
was $50.1 million.
2017 Term Loan
In August 2017, the Company entered into the 2017 Term Loan with OrbiMed, which has a maximum borrowing
capacity of $100.0 million. On the closing date of August 8, 2017, the Company borrowed $75.0 million, with the
remaining $25.0 million available to borrow at the Company’s option at any time through December 31, 2019, subject to
standard conditions. The amounts borrowed under 2017 Term Loan will primarily be used for general corporate purposes
and to fund and support the Company’s business and operations. Interest is accrued on the outstanding balance of the loan
at a rate equal to the sum of (i) 8.75% plus (ii) the higher of 1.00% or LIBOR. The 2017 Term Loan has an eighty-four
month term and will mature in August 2024. The Company is required to make interest payments on a quarterly basis,
with repayment of the full outstanding balance on the maturity date. The Company’s obligations under the 2017 Term
Loan are secured by substantially all of its assets, including its intellectual property, subject to certain customary exceptions.
On December 31, 2018, the Company amended certain terms in the 2017 Term Loan with OrbiMed. The
amendment increased the existing unused borrowing capacity from $25.0 million to $50.0 million and extended the
expiration date for the option to draw the additional to March 31, 2019. If the Company has drawn from the unused
borrowing capacity of $50.0 million, the interest rate described above would instead decrease to the sum of (i) 8.25% plus
(ii) the higher of 1.00% or LIBOR. If the amount drawn is less than $50.0 million, the interest rate would remain at the
sum of (i) 8.75% plus (ii) the higher of 1.00% or LIBOR.
In April 2019, the Company entered into a second amendment of the 2017 Term Loan with OrbiMed to further
extend the expiration date until December 31, 2019 to draw the unused borrowing capacity of $50.0 million. In the second
amendment, the interest rate is equal to the sum of (i) 8.25% plus (ii) the higher of 1.00% or LIBOR, provided the Company
draws the minimum capacity of $25.0 million. If the amount drawn is less than $25.0 million, the interest rate would
remain at the sum of (i) 8.75% plus (ii) the higher of 1.00% or LIBOR. As a fee in consideration of extending the
commitment to provide this option to draw until December 31, 2019, the Company issued an additional 25,000 shares of
our common stock to OrbiMed on April 29, 2019. As of December 31, 2019, the Company did not exercise such option,
and the right to draw the unused borrowing capacity has expired.
The 2017 Term Loan contains customary affirmative and negative covenants including financial information
maintenance covenants, indebtedness limitation covenants, minimum net revenues covenants, and investment covenants.
It also includes standard events of default such as payment defaults and nonperformance of obligations and covenants
described above. Upon an event of default, an additional interest of 3.00% may be applied to the outstanding debt balance
until such default is cured, and OrbiMed may declare all outstanding obligations immediately due and payable. As of
December 31, 2019, the Company was in compliance with all of its covenants under the 2017 Term Loan.
126
The Company is allowed to voluntarily make prepayments on its outstanding debt balance either partially or in
full. When prepayments are made, an additional prepayment premium will be applied to the outstanding principal amount
at the time. The prepayment premium will gradually reduce from 12.5% to 2.5% over the term of the loan.
On August 14, 2017, the Company paid OrbiMed a fee in consideration of providing the 2017 Term Loan by
issuing 300,000 shares of its common stock. The fair value of the fee was $2.4 million, which was determined based on
the Company’s stock price of $8.16 on August 8, 2017. Additionally, the Company paid legal fees of $0.3 million in
connection with this term loan. Total debt issuance costs incurred amounted to $2.7 million, which is accounted for as a
debt discount to be amortized on a straight-line basis over the term of the loan. The Company has classified $2.0 million
of the debt discount as a direct reduction from the outstanding debt balance of $75.0 million, while the remainder is
classified as noncurrent assets (as described in Note 6).
For the years ended December 31, 2019, 2018, and 2017 interest expense totaling $9.0 million, $8.6 million, and
$3.2 million was recorded, respectively, which also included the amortization of debt discount. Debt discount amortized
as interest expense was $0.5 million and $0.4 million for the years ended December 31, 2019 and 2018, respectively. In
addition, the Company made interest payments totaling $10.7 million and $6.1 million during the years ended
December 31, 2019 and 2018, respectively. The Company has not made any principal payment as it is not required to
repay the outstanding balance until August 2024.
The following table indicates how the Company reported its long-term debt at the end of the period:
(Amounts in thousands)
Debt principal balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Less: unamortized debt discount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net carrying amount at end of period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
75,000 $
(1,344)
73,656 $
75,000
(1,643)
73,357
December 31,
December 31,
2019
2018
11. Warrants
In April 2014, the Company granted warrants to purchase approximately 376,691 warrants to purchase common
stock with an exercise price of $2.3229 per common share. The warrants were granted to ROS Acquisition Offshore LP
in connection with the Company’s senior secured term loan that has since been repaid and have an expiration date of
April 18, 2023. It was determined that the warrants granted are detachable and therefore are a stand-alone component of
the senior secured term loan to be fair valued using Level III inputs as a separate derivative.
On June 26, 2018, the warrants were fully exercised by ROS using the option of net share settlement. Instead of
remitting cash exercise proceeds to purchase the shares, ROS elected to receive a net amount of 332,896 shares. The
Company remeasured the fair value of its warrant liability to $6.8 million during this period until June 26, 2018 and
reclassified this amount to stockholders’ equity.
12. Stockholders’ Equity
As of December 31, 2019, the Company had 50,000,000 authorized shares of its preferred stock, of which no
shares were issued and outstanding; and 750,000,000 authorized shares of its common stock, at $0.0001 par value, and
there were 78,004,669 shares of common stock issued and outstanding.
In August 2017, the Company paid OrbiMed a fee in consideration of providing the 2017 Term Loan (as defined
in Note 9) by issuing 300,000 shares of its common stock. The fair value of the fee was $2.4 million, which was determined
based on the Company’s stock price of $8.16 on August 8, 2017.
In June 2018, OrbiMed exercised all of its warrants, which were all converted into common stock. The exercise
was a cashless transaction, and there were 332,896 of net shares issued to OrbiMed following the exercise at the fair value
of $6.8 million.
127
In July 2018, the Company completed an equity offering to sell 4,500,000 shares of its common stock to the
public at a price of $20 per share, along with the sale of 675,000 additional shares of its common stock to the underwriters
upon their exercise of the option to purchase those shares. Upon the closing of the equity offering, the Company received
proceeds of $97.3 million before offering expenses, which totaled approximately $0.5 million.
In April 2019, the Company completed an underwritten equity offering to sell 5,263,158 shares of its common
stock at a price to the public of $19 per share. On April 26, 2019, the Company sold an additional 789,473 shares of its
common stock to the underwriters at the same price upon their exercise of the option to purchase those shares. Before
offering expenses of $0.6 million, the Company received proceeds of $108.1 million net of the underwriting discount.
In October 2019, the Company completed an underwritten equity offering to sell 5,714,286 shares of its common
stock at a price to the public of $35 per share. The same day, the Company sold an additional 857,142 shares of its common
stock to the underwriters at the same price upon their exercise of the option to purchase those shares. Before offering
expenses of $0.4 million, the Company received proceeds of $216.2 million net of the underwriting discount.
13. Disposal of Business
Sale of Evercord
In September 2019, the Company sold the Evercord business that provides cord blood and cord tissue processing
and storage services for total estimated consideration of $15.4 million, including $9.7 million in cash, $1.0 million of cash
deposited in a third-party escrow account recorded in short-term other receivables, and $4.7 million of additional
consideration. The additional consideration is primarily related to the accounts receivable transferred to the buyer. The
cash held in escrow serve as security for the indemnification obligations of the Company and eligible for release 12 months
after the closing date. The assets relating to the Evercord services transferred to the buyer had a net book value of $6.2
million as of the sale date, and consisted of accounts receivables and equipment. The obligations and liabilities relating
to the Evercord services transferred to the buyer consisted of deferred revenues of $5.2 million. The sale of the Evercord
business did not meet criteria to be reported as a discontinued operation, because it did not represent a strategic shift with
a major effect on the Company’s operations and financial results. The Company recognized a gain of $14.4 million on the
sale, which was included in Loss from operations in the Consolidated Statements of Operations and Comprehensive Loss.
The following table summarizes the computation of the gain realized from the disposal of business:
December 31,
2019
(in thousands)
Proceeds on disposal: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Assets sold:
Accounts receivable, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipment and inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets sold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Liabilities assumed by purchaser:
Deferred revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net assets and liabilities sold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Net gain realized on disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
15,377
5,782
419
6,201
5,212
989
14,388
128
In connection with the sale of the Evercord business, the Company recorded impairment expense on the retained
assets previously used in this business of $1.7 million in selling, general, and administrative expenses in the consolidated
statement of operations and comprehensive loss. This expense is comprised of $1.2 million from the impairment of
leasehold improvements, $0.1 million from the impairment of capitalized software held for internal use, and $0.4 million
of right-of-use asset from the storage facility lease. In addition, the Company expects to incur $0.4 million of exit or
disposal activity—$0.1 million of involuntary employee termination benefits were incurred in the third quarter of 2019,
recorded in selling, general and administrative expense in the consolidated statements of operations and comprehensive
loss, and $0.3 million of early contract termination fee from biological sample processing and storage provider to be
incurred in the next fiscal year.
14. Income Taxes
The Company's effective tax rates for the years ended December 31, 2019, 2018 and 2017 differ from the U.S.
federal statutory rate as follows:
2019
Year Ended December 31,
2018
(in thousands, except percentages)
2017
U.S. federal taxes (benefit) at statutory rate . . . . $ (25,794) (21.00)% $ (26,800) (21.00)% $ (46,206) (34.00)%
(4.83)%
State tax expense . . . . . . . . . . . . . . . . . . . . . . . . .
(0.85)%
Research and development credits . . . . . . . . . . .
(3.71)%
Stock-based compensation . . . . . . . . . . . . . . . . .
32.89 %
Change in federal tax rate . . . . . . . . . . . . . . . . . .
(0.29)%
Mark to market fair value adjustments . . . . . . . .
2.85 %
Nondeductible settlement for claims . . . . . . . . .
0.11 %
Foreign tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0.63 %
Other nondeductible items . . . . . . . . . . . . . . . . . .
7.51 %
Change in valuation allowance . . . . . . . . . . . . . .
0.31 %
Provision for income taxes . . . . . . . . . . . . . . . . . $
(5.38)%
(6,607)
(1.34)%
(1,645)
(6.14)%
(7,544)
0.00 %
—
0.00 %
—
0.00 %
—
1.31 %
1,612
1.12 %
1,378
40,599 33.06 %
1.63 % $
1,999
(3.50)%
(0.91)%
(2.47)%
0.00 %
0.68 %
0.00 %
0.15 %
0.54 %
34,150 26.76 %
0.25 % $
(6,559)
(1,149)
(5,036)
44,701
(390)
3,873
153
856
10,211
454
(4,468)
(1,164)
(3,148)
—
865
1
195
690
321
During the year ended December 31, 2019, the Company recorded total income tax expense of $2.0 million. The
Company incurred $1.9 million of foreign withholding tax on a license agreement signed in February 2019. The Company
provides testing to clinics and also licenses its cloud-based software to licensees that are based in a foreign country, which
contributed to a foreign income tax expense of $0.1 million. Total income tax expense also included a state income tax
benefit of $41,000 for the year ended December 31, 2019.
During the year ended December 31, 2018, the Company recorded total income tax expense of $0.3 million,
which included foreign income tax expense of $0.2 million and state income tax expense of $0.1 million. During the year
ended December 31, 2017, the Company recorded total income tax expense of $0.5 million, which included foreign income
tax expense of $0.3 million and state income tax expense of $0.2 million.
129
Deferred income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and
liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss and
tax credit carryforwards. The components of the net deferred income tax assets are as follows:
Deferred tax assets:
Net operating loss carryforwards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Research and development tax credit carryforwards . . . . . . . . . . . . . . . . . . . . . . . . .
Reserves and accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease Liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total deferred tax assets before valuation allowance . . . . . . . . . . . . . . . . . . . . . . . .
Less: valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2019
2018
(in thousands)
124,777 $
18,189
10,002
7,838
3,288
6,106
170,200
(163,040)
7,160
95,321
15,632
7,839
—
83
4,076
122,951
(122,441)
510
Deferred tax liabilities:
Property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right-of-use lease assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
—
(7,160)
— $
(510)
—
—
The Company established a full valuation allowance against its net deferred tax assets in 2019 and 2018 due to
the uncertainty surrounding realization of these assets. The valuation allowance increased to $163.0 million as of
December 31, 2019 from $122.4 million as of December 31, 2018. The valuation allowance increased during 2019 due to
current year losses and credits claimed. The valuation allowance increased to $122.4 million as of December 31, 2018
from $95.8 million as of December 31, 2017.
As of December 31, 2019, the Company had federal and state net operating loss (“NOLs”) carryforwards of
approximately $514.0 million and $271.6 million, respectively, which begin to expire in 2027 and 2028, respectively, if
not utilized. Approximately $194.2 million of federal net operating loss included above can be carried forward indefinitely.
The Company also had federal research and development credit carryforwards of approximately $15.7 million,
which begin to expire in 2027, and state research and development credit carryforwards of approximately $13.0 million,
which can be carried forward indefinitely. Realization of these deferred tax assets would require $650.1 million in taxable
income to fully utilize. Realization is dependent on generating sufficient taxable income prior to expiration of the loss and
credit carryforwards.
Federal and California tax laws impose substantial restrictions on the utilization of NOLs and credit carryforwards
in the event of an "ownership change" for tax purpose, as defined in Section 382 of the Internal Revenue Code. Accordingly,
the Company's ability to utilize these carryforwards may be limited as the result of such ownership change. Such a
limitation could result in limitation in the use of the NOLs in future years and possibly a reduction of the NOLs available.
130
A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows:
2019
Year Ended December 31,
2018
(in thousands)
2017
Balance at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Additions based on tax positions related to the current year . . . . . . . . . . . . . . . . .
Additions (reductions) for tax positions of prior years . . . . . . . . . . . . . . . . . . . . . .
Balance at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
7,362 $
1,426
(169)
8,619 $
5,945 $
1,416
1
7,362 $
4,293
1,651
1
5,945
The Company adopted the provisions of ASC 740-10-50, Accounting for Uncertainty in Income Taxes, on
January 1, 2009. During the years ended December 31, 2019, 2018 and 2017, the amount of unrecognized tax benefits
increased $1.3 million, $1.4 million, and $1.7 million, respectively, due to additional research and development credits
generated during the year. As of December 31, 2019, 2018 and 2017, the total amount of unrecognized tax benefits was
$8.6 million, $7.4 million and $5.9 million, respectively. The reversal of the uncertain tax benefits would not affect the
Company's effective tax rate to the extent that it continues to maintain a full valuation allowance against its deferred tax
assets.
The Company is subject to U.S. federal income taxes and to income taxes in various states in the United States.
Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations, and require
significant judgment to apply. The Company is subject to U.S. federal, state and local tax examinations by tax authorities
for all prior tax years since incorporation. The Company does not anticipate significant changes to its current uncertain tax
positions through December 31, 2020.
The Company recognizes any interest and/or penalties related to income tax matters as a component of income
tax expense. As of December 31, 2019, there were no accrued interest and penalties related to uncertain tax positions.
15. Net Loss per Share
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to
common stockholders by the weighted-average number of shares of common stock outstanding for the period.
In periods when the Company has incurred a net loss, common stock equivalents such as outstanding common
stock options, restricted stock units, unvested common shares subject to repurchase and warrants are excluded from the
calculation of diluted net loss per share as they give an anti-dilutive effect.
For the year ended December 31, 2017, the Company reversed $1.1 million of remeasurement gain on the change
in the fair value of warrants from its net loss and included the incremental shares from the assumed exercise of the warrants
in the computation of its weighted-average shares outstanding as they yielded a dilutive effect to the net loss per share in
the period. Other potentially dilutive common stock equivalents such as outstanding common stock options, shares to be
purchased under the employee stock purchase plan, and restricted stock units were excluded as their effect was anti-dilutive
and the net loss per share would be reduced.
131
The following table provides the basic and diluted net loss per share computations for the years ended
December 31, 2019, 2018 and 2017:
(in thousands, except per share data)
Year ended December 31,
2018
2019
2017
Numerator:
Net loss used to compute net loss per share, basic . . . . . . . . . . . . . . . . . . . . . . $ (124,827) $ (128,154) $ (137,628)
(1,148)
Less: Remeasurement gain on warrant liability . . . . . . . . . . . . . . . . . . . . . . . .
Net loss used to compute net loss per share, diluted . . . . . . . . . . . . . . . . . . . . . $ (124,827) $ (128,154) $ (138,776)
—
—
Denominator:
Weighted-average common shares outstanding . . . . . . . . . . . . . . . . . . . . . . . .
Less: Weighted-average unvested common shares subject to repurchase . . .
Weighted-average number of shares used in computing net loss per share,
69,555
—
57,848
—
53,312
—
basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
69,555
57,848
53,312
Add: Incremental shares from assumed exercise of warrants . . . . . . . . . . . . .
Weighted-average number of shares used in computing net loss per share,
—
—
292
diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
69,555
57,848
53,604
Net loss per share, basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Net loss per share, diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(1.79) $
(1.79) $
(2.22) $
(2.22) $
(2.58)
(2.59)
The following table shows the potentially dilutive common stock equivalents that were excluded from the
computations of diluted net loss per share as their effect would be anti-dilutive, as of December 31, 2019, 2018 and 2017:
Options to purchase common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted stock units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Employee stock purchase plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As of December 31,
2019
2018
2017
8,497
2,404
32
10,933
9,463
1,084
42
10,589
9,963
389
79
10,431
132
16. Quarterly Financial Data (unaudited)
December 31,
September 30,
June 30,
March 31,
(in thousands, except per share data)
Three months ended
2019
Operating results:
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Cost of product revenues . . . . . . . . . . . . . . . . . . . . .
Cost of licensing and other revenues . . . . . . . . . . .
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense and other (expense) income, net .
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
83,240 $
39,479
4,983
38,778
73,589
(386)
14
(35,183) $
77,909 $
40,138
3,742
34,029
55,123
(1,999)
(44)
(23,137) $
74,355 $
41,382
2,443
30,530
59,166
(1,885)
(1,895)
(32,416) $
66,824
41,605
1,698
23,521
55,267
(2,271)
(74)
(34,091)
Per share data:
Net loss - basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Net loss - diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(0.46) $
(0.46) $
(0.33) $
(0.33) $
(0.48) $
(0.48) $
(0.54)
(0.54)
2018
Operating results:
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Cost of product revenues . . . . . . . . . . . . . . . . . . . . .
Cost of licensing and other revenues . . . . . . . . . . .
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense and other (expense) income, net .
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
66,965 $
40,345
2,444
24,176
53,903
(2,128)
14
(31,841) $
65,280 $
39,477
2,202
23,601
50,767
(2,332)
(118)
(29,616) $
63,069 $
39,204
1,791
22,074
49,292
(6,493)
(113)
(33,824) $
62,340
39,055
1,537
21,748
52,265
(2,252)
(104)
(32,873)
Per share data:
Net loss - basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Net loss - diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(0.51) $
(0.51) $
(0.49) $
(0.49) $
(0.62) $
(0.62) $
(0.61)
(0.61)
133
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 and our Chief Financial Officer,
evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2019. The term “disclosure
controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and
other procedures of a company that are designed to ensure that information required to be disclosed by a company in the
reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time
periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a
company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the
company’s management, including its principal executive and principal financial officers, as appropriate to allow timely
decisions regarding required disclosure.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2019, management has
concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting as
defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control over financial reporting is designed
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management has evaluated the effectiveness of our internal control over financial reporting as of December 31,
2019 using the criteria set forth in the 2013 Internal Control — Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (“COSO”). Based on our evaluation, management has
concluded that we maintained effective internal control over financial reporting as of December 31, 2019 based on the
COSO criteria.
The effectiveness of our internal control over financial reporting as of December 31, 2019 has been audited by
Ernst & Young LLP, an independent registered public accounting firm, as stated in their report which appears in Item 8
of this Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the
evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended
December 31, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
134
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, do not expect that our
disclosure controls or our internal control over financial reporting will prevent all errors and all fraud. A control system,
no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the
control system are met. Further, the design of a control system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any,
have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and
that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the
individual acts of some persons, by collusion of two or more people or by management override of the controls. The
design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;
over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies
or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due
to error or fraud may occur and not be detected.
135
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Natera, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Natera, Inc.’s internal control over financial reporting as of December 31, 2019, based on criteria
established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (2013 framework), (the COSO criteria). In our opinion, Natera, Inc. (the Company) maintained,
in all material respects, effective internal control over financial reporting as of December 31, 2019, based on the COSO
criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the 2019 consolidated financial statements of the Company and our report dated February 28,
2020 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting included in the accompanying Management
Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company's
internal control over financial reporting based on our audit. We are a public accounting firm registered with the 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a
material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the
assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that
our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company‘s internal control over financial reporting is a process designed to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. A company’s internal control over financial reporting includes those policies
and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of
management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
/s/ Ernst & Young LLP
San Jose, California
February 28, 2020
136
ITEM 9B. OTHER INFORMATION
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item will be contained in our definitive proxy statement to be filed with the
Securities and Exchange Commission in connection with our 2020 annual meeting of stockholders (the “Proxy
Statement”), which we expect to file no later than 120 days after the end of our fiscal year ended December 31, 2019,
and is incorporated in this report by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be contained in the Proxy Statement, which we expect to file no later
than 120 days after the end of our fiscal year ended December 31, 2019, and is incorporated in this report by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by this item will be contained in the Proxy Statement, which we expect to file no later
than 120 days after the end of our fiscal year ended December 31, 2019, and is incorporated in this report by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by this item will be contained in the Proxy Statement, which we expect to file no later
than 120 days after the end of our fiscal year ended December 31, 2019, and is incorporated in this report by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item will be contained in the Proxy Statement, which we expect to file no later
than 120 days after the end of our fiscal year ended December 31, 2019, and is incorporated in this report by reference.
137
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this Annual Report on Form 10-K:
(1) Financial Statements (included in Part II of this report):
• Report of Independent Registered Public Accounting Firm
• Balance Sheets
• Statement of Operations
• Statement of Stockholders’ Equity
• Statement of Cash Flows
• Notes to Financial Statements
(2) Financial Statement Schedules:
All financial statement schedules are omitted because the information is inapplicable or presented
in the notes to the financial statements.
(b) The following exhibits are filed with or incorporated by reference as part of this Annual Report on Form 10-K:
INDEX TO EXHIBITS
Incorporated by Reference
Exhibit No.
Description
Form
File No.
Exhibit
Filing Date
3.1
3.2
4.1
4.2
4.3
10.1*
10.2*
10.3*
10.4
8-K
001-37478
3.1
7/9/2015
Amended and Restated Certificate of
Incorporation of Natera, Inc.
Amended and Restated Bylaws of
Natera, Inc.
Form of Common Stock Certificate
S-1/A
333-204622
8-K
001-37478
3.2
4.1
7/9/2015
6/22/2015
Amended and Restated Investors'
Rights Agreement, dated November 20,
2014.
Description of Common Stock
2007 Stock Plan and form of
agreements thereunder.
2015 Equity Incentive Plan and forms
of agreements thereunder.
S-1
333-204622
4.2
6/1/2015
S-1
333-204622
10.1
6/1/2015
10-K
001-37478
10.2
3/24/2016
2015 Employee Stock Purchase Plan.
S-1/A
333-204622
10.3
6/25/2015
Form of Indemnification Agreement, by
and between Registrant and each of its
directors and executive officers.
10-K
001-37478
10.4
3/16/2017
138
Filed
Herewith
X
Exhibit No.
10.5.1**
10.5.2**
10.5.3**
10.5.4**
10.5.5***
10.6.1**
10.6.2**
10.6.3**
10.6.4**
10.7*
10.8*
10.9*
10.10*
10.11.1
10.11.2
10.12*
Description
Supply Agreement, dated
September 18, 2014, by and between
Registrant and Illumina, Inc., as
amended (conformed copy).
Second Amendment to Supply
Agreement, dated September 21, 2015,
by and between Registrant and
Illumina, Inc.
Third Amendment to Supply
Agreement, dated June 8, 2016, by and
between Registrant and Illumina, Inc.
Fourth Amendment to Supply
Agreement, dated January 3, 2019, by
and between Registrant and Illumina,
Inc.
Fifth Amendment to Supply Agreement,
dated December 18, 2019, by and
between Registrant and Illumina, Inc.
Application Service Provider
Agreement, dated September 19, 2014,
by and between Registrant and
DNAnexus, Inc., as amended
Third Amendment to Application
Service Provider Agreement, dated
January 1, 2018, by and between
Registrant and DNAnexus, Inc.
Fourth Amendment to Application
Service Provider Agreement, dated
July 1, 2018, by and between Registrant
and DNAnexus, Inc.
Fifth Amendment to Application
Service Provider Agreement, dated
October 18, 2019, by and between
Registrant and DNAnexus, Inc.
Amended Employment Agreement, by
and between Registrant and Matthew
Rabinowitz, dated June 7, 2007.
Amended Employment Agreement, by
and between Registrant and Jonathan
Sheena, dated June 7, 2007.
Amended and Restated Employment
Agreement, by and between Registrant
and Steve Chapman, dated January 2,
2019.
Amended Compensation Program for
Non-Employee Directors.
UBS Credit Line Agreement, dated
September 23, 2015, as amended.
Amendment to UBS Credit Line
Agreement, dated July 5, 2017.
Natera, Inc. Management Cash
Incentive Plan.
Incorporated by Reference
Form
File No.
Exhibit
Filing Date
Filed
Herewith
S-1/A
333-204622
10.13
6/30/2015
10-Q
001-37478
10.1
8/11/2016
10-Q
001-37478
10.2
8/11/2016
10-K
001-37478
10.8
3/15/2019
X
10-K
001-37478
10.11
3/16/2017
10-Q
001-37478
10.1
11/9/2018
10-Q
001-37478
10.2
11/9/2018
10-Q
001-37478
10.2
11/8/2019
S-1/A
333-204622
10.15
6/25/2015
S-1/A
333-204622
10.16
6/25/2015
10-Q
001-37478
10.1
5/10/2019
10-Q
001-37478
10.2
5/10/2019
10-Q
001-37478
10.2
11/12/2015
10-Q
001-37478
10.1
8/9/2017
10-Q
001-37478
10.3
11/12/2015
139
Exhibit No.
10.13.1
Description
Lease, dated October 26, 2015, by and
between Registrant and BMR-201
Industrial Road LP.
Incorporated by Reference
Form
File No.
Exhibit
Filing Date
Filed
Herewith
10-K
001-37478
10.23
3/23/2016
10.13.2
10.14.1**
10.14.2**
10.14.3**
10.14.4**
10.15**
10.16
10.17**
21.1
23.1
24.1
31.1
First Amendment to Lease, dated
October 6, 2016, by and between
Registrant and BMR-201 Industrial
Road LP.
Credit Agreement, dated as of August 8,
2017, by and between Registrant and
OrbiMed Royalty Opportunities II, LP.
Amendment and Waiver to Credit
Agreement, dated as of December 28,
2018, by and between Registrant,
Natera International, Inc., NSTX, Inc.
and OrbiMed Royalty Opportunities II,
LP.
Second Amendment to Credit
Agreement, dated as of April 15, 2019,
by and between Registrant, Natera
International, Inc., NSTX, Inc. and
OrbiMed Royalty Opportunities II, LP.
Third Amendment to Credit Agreement,
dated as of September 12, 2019, by and
between Registrant, Natera
International, Inc., NSTX, Inc. and
OrbiMed Royalty Opportunities II, LP.
Pledge and Security Agreement, dated
as of August 8, 2017, by and between
Registrant, Natera International, Inc.,
NSTX, Inc. and OrbiMed Royalty
Opportunities II, LP.
Guarantee, dated as of August 8, 2017,
by and between Natera International,
Inc., NSTX, Inc. and OrbiMed Royalty
Opportunities II, LP.
License, Development and Distribution
Agreement, dated as of March 9, 2018,
by and between Registrant and
QIAGEN LLC
10-Q
001-37478
10.1
11/10/2016
10-Q
001-37478
10.1
11/9/2017
10-K
001-37478
10.20
3/15/2019
10-Q
001-37478
10.3
5/10/2019
10-Q
001-37478
10.1
11/8/2019
10-Q
001-37478
10.2
11/9/2017
10-Q
001-37478
10.3
11/9/2017
10-Q/A
001-37478
10.1
2/6/2019
List of Subsidiaries of the Registrant.
10-K
001-37478
21.1
3/16/2017
Consent of Independent Registered
Public Accounting Firm.
Power of Attorney (see signature page
of this Annual Report on Form 10-K).
Certification of Principal Executive
Officer required by Rule 13a-14(a) or
Rule 15d-14(a) of the Securities
Exchange Act of 1934, as adopted
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
140
X
X
X
Exhibit No.
Description
Form
File No.
Exhibit
Filing Date
Filed
Herewith
Incorporated by Reference
31.2
32.1†
32.2†
Certification of Principal Financial
Officer pursuant to Rule 13a-14(a) or
Rule 15d-14(a) of the Securities
Exchange Act of 1934, as adopted
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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.
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.
101.INS
XBRL Instance Document.
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
104
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.
Cover Page Interactive Data File
(formatted as Inline XBRL and
contained in Exhibit 101)
X
X
X
X
X
X
X
X
X
X
*
Indicates a management contract or compensatory plan.
** Portions of this exhibit (indicated by asterisks) have been omitted pursuant to an order granting confidential treatment.
Omitted portions have been submitted separately to the Securities and Exchange Commission (SEC).
*** Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment.
Omitted portions have been submitted separately to the SEC.
† The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K are not deemed
filed with the SEC and are not to be incorporated by reference into any filing of Natera, Inc. 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, regardless of any general incorporation language contained in any filing.
ITEM 16. FORM 10-K SUMMARY
None.
141
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Annual
Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Carlos,
State of California, on this 28th day of February, 2020.
SIGNATURES
Natera, Inc.
/ s / Michael Brophy
Michael Brophy
Chief Financial Officer
142
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby
constitutes and appoints Steve Chapman and Michael Brophy as his or her true and lawful attorney-in-fact and agent with
full power of substitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report
on Form 10-K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and
perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents
and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent,
or his substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K
has been signed by the following persons in the capacities and on the dates indicated.
Signature
/ s / Steve Chapman
Steve Chapman
Title
Chief Executive Officer, President and
Director
(Principal Executive Officer)
Date
February 28, 2020
/ s / Michael Brophy
Michael Brophy
Chief Financial Officer
(Principal Financial and Accounting Officer)
February 28, 2020
/ s / Jonathan Sheena
Jonathan Sheena
/ s / Matthew Rabinowitz
Matthew Rabinowitz
/ s / Roy Baynes
Roy Baynes
/ s / Roelof F. Botha
Roelof F. Botha
/ s / Rowan Chapman
Rowan Chapman
/ s / Todd Cozzens
Todd Cozzens
/ s / James I. Healy
James I. Healy
/ s / Gail Marcus
Gail Marcus
/ s / Herm Rosenman
Herm Rosenman
Chief Technology Officer and Director
February 28, 2020
Executive Chairman
February 28, 2020
February 28, 2020
February 28, 2020
February 28, 2020
February 28, 2020
February 28, 2020
February 28, 2020
February 28, 2020
Director
Director
Director
Director
Director
Director
Director
143
Natera,(cid:3)Inc.(cid:3)
201(cid:3)Industrial(cid:3)Road,(cid:3)Suite(cid:3)410(cid:3)
San(cid:3)Carlos,(cid:3)California(cid:3)94070(cid:3)
(650)(cid:3)249(cid:3)9090(cid:3)
www.natera.com(cid:3)