2020
ANNUAL
REPORT
Dear
Fellow
Stockholders,
As I reflect on all we have accomplished in 2020, I
dedication, loyalty and commitment to
Castle and
This year was unlike any other
it was a year like no other in terms of
our successes.
I can recall. And although we faced
would like to thank our employees
to
improving the lives of
for
their
patients
a formidable foe
with cancer.
with COVID-19,
2020 Highlights
more than
gene expression profile
18,000
We delivered
result of the creative, effective pivot by our commercial
response to
restrictions on in-person visits
volume increased in 2020 compared to
melanoma
significantly.
being down
despite
2019,
caused by COVID-19.
(GEP)
and
medical
In
tests in 2020.
part,
large
and their great
DecisionDx-Melanoma test report
teams
as a
the number of patients diagnosed with
Our revenue for 2020 was $62.6
faced from the pandemic.
million. A 21% increase over 2019, despite the headwinds we
On the back of two successful
million in
us to
cash and cash equivalents
accelerate
fund-raising efforts,
and no debt.
our growth trajectory.
continue to
we ended the year with
We believe our healthy balance sheet will enable
approximately
$410
Evidence development is
pipeline development.
published 11 peer-reviewed articles in 2020.
pipeline products.
a key component
The strength of our
success of
for
R & D team
adoption of
is unmatched,
genomic
our
and they successfully
tests and
All of this while
building the foundation
for our new
We also launched not one, but two new tests in 2020, a significant achievement for any year, even
more so as we faced extraordinary challenges from COVID-19.
Said another way, we started 2020
with one skin cancer test and
have expanded our competitive edge to
of three.
include
suite
a
Looking
Forward
toward the future
and
the continuation of
our
strong growth trajectory
and value
have
As we look
creation, we
long-term. We
expect to
currently marketed tests.
in the first half of
pipeline, with
2021
strategically outlined a well-defined
revenue growth plan for the near-, mid-
continue building our expansive body of evidence to support our four
We also anticipate that our commercial team
expansion will be complete
and
the possible launch of
as planned, and of course, the R & D team
3-5 new tests by
the end of
is
2025.
focused on building a robust
In closing, I would like to
stockholders, for your continued support. We
what is to come.
again
thank our Castle Biosciences
employees, as well as you, our
are excited
about the progress we have made and
Sincerely,
Derek Maetzold
Founder, President & CEO
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, 2020
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: 001-38984
CASTLE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or
organization)
820 S. Friendswood Drive, Suite 201,
Friendswood, Texas
(Address of principal executive offices)
77-0701774
(I.R.S. Employer Identification No.)
77546
(Zip Code)
(866) 788-9007
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
CSTL
The Nasdaq Global Market
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ¨
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes ☒ No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report. ☐
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 voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2020 (the last
business day of the registrant’s most recently completed second fiscal quarter) was $518.9 million based on the closing price of the
registrant’s common stock on June 30, 2020, as reported by the Nasdaq Global Market.
As of March 5, 2021, there were 24,978,424 shares of common stock, $0.001 par value per share, issued and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission, or SEC, subsequent to the
date hereof pursuant to Regulation 14A in connection with the registrant’s 2021 Annual Meeting of Stockholders, are incorporated by
reference into Part III of this Annual Report on Form 10-K. We intend to file such proxy statement with the SEC not later than 120 days after
the conclusion of the registrant’s fiscal year ended December 31, 2020.
Table of Contents
Special Note Regarding Forward-Looking Statements
Risk Factors Summary
PART I.
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II.
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A
Item 9B.
PART III.
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV.
Item 15.
Item 16.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
Exhibits, Financial Statement Schedules
Form 10-K Summary
SIGNATURES
INDEX TO FINANCIAL STATEMENTS
Page
2
3
5
5
34
72
72
72
72
73
73
74
74
88
88
88
89
89
90
90
90
90
90
90
91
91
93
94
F-1
1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements. The forward-looking statements are contained
principally in the sections entitled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and “Business.” These statements relate to future events or to our future financial performance and involve
known and unknown risks, uncertainties and other factors which 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. Forward-looking statements include, but are not limited to, statements about:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
estimates of our addressable market, future revenue, expenses, capital requirements and our needs for additional
financing;
expectations with respect to reimbursement for our products, including third-party payor reimbursement and coverage
decisions;
anticipated cost, timing and success of our products in development, and our plans to research, develop and
commercialize new tests;
the impact of the COVID-19 pandemic on our business;
our ability to obtain funding for our operations, including funding necessary to complete the expansion of our
operations and development of our product candidates;
the implementation of our business model and strategic plans for our products, technologies and businesses;
our ability to manage and grow our business by expanding our sales to existing customers or introducing our products
to new customers;
our ability to develop and maintain sales and marketing capabilities;
regulatory developments in the United States and foreign countries;
the performance of our third-party suppliers;
the success of competing diagnostic products that are or become available;
our ability to attract and retain key personnel;
our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart
Our Business Startups Act, as amended, or the JOBS Act, enacted in April 2012; and
our expectations regarding our ability to obtain and maintain intellectual property protection for our products and our
ability to operate our business without infringing on the intellectual property rights of others.
In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expects,”
“intend,” “may,” “plan,” “potential,” “project,” “should,” “will,” “would” or the negative of those terms, and similar
expressions that convey uncertainty of future events or outcomes. These forward-looking statements reflect our management’s
beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Annual Report
on Form 10-K and are subject to risks and uncertainties. In addition, statements that “we believe” and similar statements reflect
our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of
this Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for such statements, such
information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an
exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain
and investors are cautioned not to unduly rely upon these statements. We discuss many of the risks associated with the forward-
looking statements in this Annual Report on Form 10-K in greater detail under the heading “Risk Factors.” Moreover, we
operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we
may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
2
RISK FACTORS SUMMARY
We face many risks and uncertainties, as more fully described in this Annual Report on Form 10-K under the heading “Risk
Factors.” Some of these risks and uncertainties are summarized below. The summary below does not contain all of the
information that may be important to you, and you should read this summary together with the more detailed discussion of
these risks and uncertainties contained in “Risk Factors.”
Risk Related to our Financial Condition
Our method of recognizing revenue may not reflect our underlying business.
• We rely upon a small number of third-party payors for a significant portion of our revenue.
•
• We have incurred significant losses since inception, and we may never achieve profitability.
• We are an early, commercial-stage company and have a limited operating history, which may make it difficult to
•
•
evaluate our current business and predict our future performance.
Our financial results could fluctuate in the future, causing the market price of our stock to decline substantially.
If our internal control over financial reporting is ineffective, we may not be able to accurately report our financial
results or file our periodic reports in a timely manner.
• We may need to raise additional capital to commercialize new products, to expand operations or to fund existing
operations.
Risks Related to our Business
• We have been, and may continue to be, adversely impacted by the COVID-19 pandemic, which has caused decreased
•
test report volume.
Our revenue heavily relies upon the sale of a single product and our current or future products may not achieve or
maintain significant commercial market acceptance.
Billing for our products is complex and we require substantial time and resources to collect payment.
•
• We rely on third parties for tumor sample collection, preparation and delivery.
•
•
A depletion or loss of our tumor sample database could significantly harm our business.
If our primary clinical laboratory facility becomes damaged or inoperable or we are required to vacate our existing
facility, our ability to conduct our laboratory analysis and pursue our research and development efforts may be
jeopardized.
Our current or future products may not achieve or maintain significant commercial market acceptance.
New product development is lengthy and complex and our revenues could be limited if we are unable to increase and
support adoption of our products by healthcare providers.
•
•
• We may experience limits on our revenue if we are unable to increase and support adoption of our products by both
physicians and other healthcare providers.
• We rely on limited or sole suppliers for some of the reagents, equipment, chips and other materials used by our
products, and we may not be able to find replacements or transition to alternative suppliers.
The sizes of the markets for our current and future products have not been established with precision and may be
smaller than we estimate.
The diagnostic testing industry is subject to rapid change, which could make our current or future products obsolete.
•
•
Risks Related to Reimbursement and Government Regulation
• We currently have limited reimbursement coverage for our lead product, DecisionDx-Melanoma, and if third-party
payors, including government and commercial payors, do not provide sufficient coverage of, or adequate
reimbursement for, our products, our commercial success, including revenue, will be negatively affected.
• We conduct business in a heavily regulated industry and failure to comply with regulatory requirements, including
those established by the Centers for Medicare & Medicaid Services, or CMS, and the U.S. Food and Drug
Administration, or FDA, or changes in enforcement discretion for laboratory developed tests could harm our business.
Data from our clinical studies may change materially, which could harm our business.
Changes in health care policy or healthcare statutes and regulations or our ability to comply with applicable
requirements could cause a material adverse effect to our business and operations.
•
•
Risks Related to Intellectual Property
•
If we are unable to obtain and maintain sufficient intellectual property protection for our technology, our ability to
successfully commercialize our products may be impaired.
3
•
Our commercial success depends significantly on our ability to operate without infringing upon the intellectual
property rights of third parties.
• We rely on information technology systems that we license from third parties and other royalty-bearing license
agreements.
Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business
• We are highly dependent on the services of our key personnel, including our President and Chief Executive Officer.
Our employees and any current or potential commercial partners may engage in misconduct or other improper
•
activities, including non-compliance with regulatory standards and requirements and insider trading.
• We may engage in strategic transactions, such as the acquisition of businesses, assets, products or technologies, which
could be disruptive to our existing operations, divert the attention of our management team and adversely impact our
liquidity, cash flows, financial condition and results of operations.
Our business may be negatively impacted by cyber security threats, natural disasters and public health crises.
Product or professional liability lawsuits against us could cause us to incur substantial liabilities and could limit our
commercialization of our products.
•
•
Risks Related to Ownership of Our Common Stock.
•
The stock price of our common stock may be volatile or may decline regardless of our operating performance, and you
may lose all or part of your investment.
• We have broad discretion in the use of working capital and may not use it effectively or in ways that increase our share
•
•
•
price.
The concentration of our stock ownership will likely limit your ability to influence corporate matters, including the
ability to influence the outcome of director elections and other matters requiring stockholder approval.
Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated
bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our
common stock.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is
the exclusive forum for certain 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.
4
PART I
Item 1. Business.
As used in this Annual Report on Form 10-K, unless the context indicates or otherwise requires, “Castle Biosciences,” “the
Company,” “we,” “us,” and “our” refer to Castle Biosciences, Inc., a Delaware Corporation.
Overview
We are a commercial-stage dermatological cancer company focused on providing physicians and their patients with
personalized, clinically actionable genomic information to make more accurate treatment decisions. We believe that the
traditional approach to developing a treatment plan for certain cancers using clinical and pathology factors alone is inadequate
and can be improved by incorporating personalized genomic information. Our non-invasive products utilize proprietary
algorithms to provide an assessment of a patient’s specific risk of metastasis or recurrence of their cancer, allowing physicians
to identify patients who are likely to benefit from an escalation of care as well as those who may avoid unnecessary medical and
surgical interventions. Our lead product, DecisionDx®-Melanoma, is a proprietary multi-gene expression profile, or GEP, test
that predicts the risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin
cancer. This test has two current clinically actionable uses. The first use immediately following diagnosis predicts a patient’s
likelihood of having a sentinel lymph node negative biopsy result so that physicians and patients can discuss the risk and benefit
of undergoing sentinel lymph node biopsy, or SLNB, surgery. The second use is to inform the appropriate treatment plan,
regardless of the decision to undergo or avoid the SLNB surgery. We estimate more than 130,000 patients are diagnosed with
invasive cutaneous melanoma each year in the United States. We launched DecisionDx-Melanoma in May 2013.
On August 31, 2020, we commercially launched our cutaneous squamous cell carcinoma, or SCC, proprietary GEP test,
DecisionDx®‑SCC, and on November 2, 2020, we commercially launched our proprietary GEP test for suspicious pigmented
lesions, DecisionDx® DiffDx™-Melanoma. These two indications are areas of high clinical need in dermatological cancer and,
together, represent an addressable population of approximately 500,000 patients in the United States.
We also market DecisionDx®-UM, which is a proprietary GEP test that predicts the risk of metastasis for patients with uveal
melanoma, a rare eye cancer. We launched DecisionDx-UM in January 2010.
Based on the substantial clinical evidence that we have developed, we have received Medicare coverage for DecisionDx-
Melanoma and DecisionDx-UM, representing approximately 50% of the addressable patient population for both of these tests.
We have processed over 70,000 clinical samples since our inception. Our revenue for the year ended December 31, 2020 was
$62.6 million, compared to $51.9 million for 2019 and $22.8 million for 2018.
Information on our test report volumes by year is presented below:
DecisionDx-Melanoma
DecisionDx‑SCC
DecisionDx DiffDx-Melanoma
Total Proprietary Dermatologic GEP Tests
DecisionDx-UM
Total
Our Competitive Advantages
Years Ended December 31,
2020
2019
2018
2017
16,232
485
73
16,790
1,395
18,185
15,529
—
—
15,529
1,526
17,055
12,032
—
—
12,032
1,413
13,445
9,300
—
—
9,300
1,314
10,614
We are focused on providing actionable genomic information to physicians and their patients. We believe our key competitive
advantages are due in part to the following factors:
•
Development of our products required our machine learning expertise, artificial intelligence and our
proprietary algorithms, which are complex and difficult to replicate. We develop our products using our machine-
learning expertise and artificial intelligence to analyze clinical specimens with associated long-term outcomes data to
identify genomic patterns in tumor biology that we believe will accurately predict the risk of metastasis and
recurrence. We then validate these genomic patterns, by refining and locking down algorithms to enable additional
studies to validate the accuracy of our tests and subsequently document the clinically actionable changes made by
physicians when they incorporate our test results into their treatment plan decisions.
5
• We have demonstrated the ability to provide clinically actionable information despite the complex genomics of
skin cancer. In the diagnosis and prognosis of cancer, there is significant current interest in DNA driver mutations as
being a predictor of the behavior of cancers. We believe that while the behavior of some cancers may be elucidated by
DNA analysis and the response to certain targeted therapies, the majority of skin cancer behavior will best be
understood at the gene expression level. Specifically, while DNA mutations of a specific gene are important for tumor
behavior, the impact of other genes, epigenetic changes to the gene and the non-tumor environment which cannot be
discerned by the mutation that a gene carries are critical to the understanding of tumor behavior. We believe that
focusing on the expression of the gene or how the gene behaves will be more accurate than the mutation of the gene
itself.
• Our growing repository of tumor samples and associated data, some including long-term outcomes, positions us
well for improvement of current products and accelerated development of new ones. The development and
validation of accurate tests is a complex process that requires access to tumor tissue specimens and long-term
outcomes data. Such material and associated data is not readily available for skin cancer, which creates a barrier to
rapid test development and validation. However, over the last decade we have accrued a sample bank comprised of
approximately 60,000 samples, including 6,000 well-annotated samples that we have used in our clinical studies to
date. We have been able to use this sample bank to expand the clinical use of our products, evaluate improvements in
new and existing proprietary genomic algorithm approaches and develop new products. In addition to these historical
uses, we are exploring other opportunities involving the use of these data.
• We have generated, and will continue to generate, robust clinical validity and utility data supporting the use of
our products. For example, DecisionDx-Melanoma has been studied in more than 5,700 patient samples, including 28
published studies since 2015. We also are making significant investments in further clinical studies to continue to
support DecisionDx-Melanoma, DecisionDx-UM, DecisionDx-SCC and DecisionDx DiffDx-Melanoma. This growing
set of data is significant in educating physicians and patients about the value of our products and supporting
reimbursement of our products by third-party payors.
• We have established relationships with physicians that allow us to optimize our interactions, increase adoption
of our current products and identify areas of unmet clinical need to efficiently launch additional products. We
have published rigorous clinical data, which allows our sales and medical affairs representatives to have substantive, in
depth dialogues with physicians. Through these established relationships, we have been able to integrate our products
into physicians’ workflows and identify further educational programs, which we believe fosters adoption of our
products. We can also leverage these relationships to identify areas of significant unmet medical need and efficiently
launch additional dermatologic products.
• We have experience in navigating the reimbursement landscape. In the molecular diagnostics industry securing
reimbursement for new tests is a long, complex and uncertain process. We have developed significant expertise to
assist in securing reimbursement for our products.
Our Strategy
We intend to build upon our position as a leading provider of genomic information for dermatological cancers. To realize this
objective, we plan to:
•
•
•
Expand adoption of our currently marketed products and educate physicians and their patients on the need for
our products to make a more informed treatment plan decision. We believe that cancer treatment plans will be
most effective if decisions are personalized for each patient based on the biology of their specific tumor, instead of a
one-size-fits-all approach. We will continue to educate physicians and their patients on the diagnostic discordance that
leads to over- and under-treatment.
Continue to generate evidence supporting the clinical utility and validity of our products. We have conducted
extensive clinical utility and validity studies to support the adoption of, and reimbursement for, our products. In order
to maintain our competitive advantage and increase sales of our products, we will continue to generate additional
clinical data to support the use of our products.
Execute planned expansion of our commercial channel. We plan to increase sales of our products by adding new
physicians to our customer base as well as increasing orders by physicians already using our products. We increased
the number of sales and medical affairs representatives in the first quarter of 2019 with a second expansion occurring
in December 2019. Further, we expanded our sales organization headcount in the third quarter of 2020 in preparation
for the commercial launch of our DecisionDx DiffDx-Melanoma test. We are planning additional expansion in the first
half of 2021. We will continue to evaluate the needs of our customers and may make additional commercial
investments to better support the educational needs of our customers with our currently marketed products as well as
support the launch of additional products.
6
•
•
Expand coverage and reimbursement for our products. We plan to further increase dialogue with third-party
payors to highlight our clinical utility and patient outcomes data. We believe these data will validate the benefit of our
products for patients and will persuade more third-party payors to provide coverage and reimbursement. Additionally,
we will continue to emphasize our ability to reduce overall cost to the healthcare system by appropriately classifying
high-risk patients and removing the need for unnecessary invasive products and procedures for low-risk patients.
Utilize our development expertise and commercial channel insight to provide additional solutions. We are
continuing to develop products that address the challenges facing physicians. We have initiated work on a number of
pipeline tests which branch out upstream, downstream and parallel to our currently marketed tests. Although we are
still in the early stages of development, we believe we could launch three to five new tests by the end of 2025, utilizing
our existing sales channels, potentially adding approximately $3.6 billion to our current U.S. total addressable market,
or TAM. We expect to provide additional details on these pipeline products before the end of 2021.
Dermatologic Cancer Market Overview
Skin cancer is the uncontrolled growth of abnormal skin cells. There are six types of pre-cancers and skin cancers that result in
a total annual incidence of 5.5 million patients. The three most common forms of skin cancers are basal cell carcinomas, SCC
and cutaneous melanoma. SCC, the second most common form of skin cancer, is an uncontrolled growth of abnormal cells
arising from the squamous cells in the epidermis, the skin’s outermost layer. Melanoma, an aggressive form of skin cancer,
originates in the pigment-producing melanocytes in the basal layer of the epidermis. We do not, at this time, have an active
focus on basal cell carcinomas.
Pre-cancers include suspicious pigmented lesions, which are unusual-looking lesions that may be melanoma, and actinic
keratosis, also known as a solar keratosis.
1.
2.
3.
4.
U.S. TAM = Total addressable market based on estimated patient population assuming average reimbursement rate among all payors.
Annual U.S. incidence for Stage I, II or III melanoma estimated at 130,000; Annual U.S. incidence for squamous cell carcinoma estimated at 1,000,000 with addressable market limited to carcinomas
with one or more high risk features; Annual U.S. incidence for suspicious pigmented lesion biopsies estimated at 2,000,000 with addressable market limited to the 15% with an indeterminant biopsy.
Clinicians who ordered DecisionDx-Melanoma in last twelve months (as of 12/31/2020)
Pathologists who provided clinical specimens for DecisionDx-Melanoma in last twelve months (as of 12/31/2020)
MCR = Medicare. MCRA = Medicare Advantage; current customer estimates based on last twelve months.
Cutaneous Melanoma
Melanoma tumors originate in the pigment-producing melanocytes in the basal layer of the epidermis. Approximately half of all
melanomas are diagnosed prior to expanding into the dermis and are classified as in situ or non-invasive melanomas and
DecisionDx-Melanoma is not used in this population. Worldwide statistics suggest that there were nearly 300,000 new cases of
melanoma diagnosed worldwide with the U.S. Surveillance, Epidemiology, and End Results, or SEER, database estimating that
approximately 96,000 invasive cutaneous melanomas are diagnosed in the United States annually. However, multiple
publications show that diagnosis of melanoma is underreported by between 30% and 72%. Using the mean of the
underreporting of these four studies, we estimate the annual incidence to be 130,000, representing an estimated U.S. TAM of
$540 million. According to these publications, underreporting reflects the fact that the majority of diagnoses are made by
community-based dermatologists and dermatopathologists rather than institutional-based specialists who more typically have
tumor registry support. Based on currently available data, we estimate the targetable clinician base is between 11,000 and
15,000.
7
Additionally, the incidence of melanoma has steadily increased annually over the last several decades, with an estimated
growth in the United States of more than 50% during the past ten years.
After a diagnosis of invasive cutaneous melanoma, healthcare providers have traditionally used clinical and pathology factors
from the initial biopsy to estimate the patient’s risk of metastasis. This estimation process, or staging, is used to determine
nearly all treatment decisions. Invasive melanoma is staged as Stage I through Stage IV. Tumors characterized as Stage I have
invaded the dermis but are thin, with less than or equal to 2.0 mm invasion into the dermis if not ulcerated or less than or equal
to 1.0 mm invasion into the dermis if ulcerated. Stage I tumors have the lowest population risk of metastasis and death from
melanoma. Stage II tumors, though localized, are thicker than 2.0 mm if not ulcerated or greater than 1.0 mm if ulcerated. Stage
III tumors have evidence of regional metastasis, such as palpable metastasis at the regional lymph node basin, in-transit or
satellite disease, or melanoma cell(s) in the SLN but without evidence of distant metastatic spread. Stage IV tumors are those in
which distant metastasis, such as to the lung or brain, has been detected.
All patients who are diagnosed with an invasive cutaneous melanoma will undergo a wide local excision procedure with the
surgical margins determined by the depth of the tumor. The invasive SLNB surgery is recommended to be considered for
patients with melanomas greater than or equal to 0.8 mm thick or thinner melanomas in the presence of an adverse pathologic
feature such as the presence of ulceration, high mitotic rate, and transected base. It is believed that tumors with these anatomic
based features have a likelihood of an SLN-positive biopsy result 5% or more of the time. If the SLNB surgery is performed,
then the wide local excision is performed at that time. As noted in the prior paragraph, an SLN-positive biopsy result, meaning
that at least one melanoma cell was seen in the SLN tissue, leads to re-staging the patient as Stage III. Guideline committees do
not recommend an SLNB if the likelihood of a positive SLN result is <5%. They recommend discussion and considering an
SLNB if the likelihood of a positive SLN falls between 5% and 10% and recommend discussing and offering an SLNB if the
likelihood is >10%. Guideline committees have selected the 5% threshold due to a reported regional false negative rate of the
SLNB surgery at 5% (meaning that 5% of the time, or more, the guideline committees expect a patient with an SLN-negative
biopsy result will subsequently develop lymph node metastasis). However, the published literature documents a median
regional false negative rate of 18% and an 11% surgical complication rate.
Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma, the second most common form of skin cancer, is an uncontrolled growth of abnormal cells
arising from the squamous cells in the epidermis, the skin’s outermost layer. Approximately one million patients are diagnosed
with SCC each year in the United States. Worldwide data on SCC is inconsistently reported but the incidence outside the
United States is estimated to be greater than two million diagnoses annually.
Historically, SCC has been classified as one of the “non-melanoma skin cancers” with a clinical focus on curative primary
surgery. However, high risk SCC is now recognized as a significant cause of morbidity and mortality and due to the rate of
increased incidence, more patients are now estimated to die annually from SCC in the United States (approximately 15,000
patients) than from cutaneous melanoma. Similar to melanoma, treatment plan decisions are based upon a patient’s estimated
risk of recurrence or metastasis. However, unlike melanoma, the estimates are based upon small patient cohorts and our
research shows that most clinicians rely upon individual clinical and pathologic features rather than a staging “group” for
guiding treatment plan decisions. Our DecisionDx-SCC test, which we launched on August 31, 2020, is for use in the estimated
200,000 patients who present with one or more high risk features, representing an estimated U.S. TAM of $820 million.
Suspicious Pigmented Lesions
Suspicious pigmented lesions are unusual-looking lesions that may be melanoma. There are approximately two million skin
biopsies performed specifically for the diagnosis of melanoma in the United States. Approximately 15% of these biopsies are
classified as indeterminate, in which case a pathologist cannot make a definitive diagnosis as to whether the biopsy is benign or
malignant. We estimate the U.S. TAM at $600 million for our DecisionDx DiffDx-Melanoma test, which we launched on
November 2, 2020.
Uveal Melanoma Market Overview
The incidence of uveal melanoma has remained relatively constant over time with approximately 1,600 to 1,700 patients
diagnosed per year in the United States, representing an estimated U.S. TAM of $7.0 million. Uveal melanomas arise from the
three tissues comprising the uveal tract and vary by location with approximately 90% occurring in choroid, 5% in the ciliary
body and 5% in the iris. Uveal melanoma may also be referred to as ocular melanoma.
Significant Limitations of Current Clinical and Pathology Staging Systems for Skin Cancer
The skin cancer disease market has significant unmet clinical needs, as clinical and pathology staging systems have traditionally
applied a population-wide approach to estimate an individual patient’s risk of metastasis and have not incorporated the
genomics of a patient’s tumor biology. This is unlike the diagnostic process applied to other solid tumors, such as breast and
prostate cancer, where the broader use of genomics to understand tumor biology has led to individualized patient treatment
8
plans. Not incorporating tumor biology leads to a discordance between the estimated and actual risk of metastasis, which results
in over- and under-treatment as well as increased healthcare costs.
Cutaneous Melanoma
The clinical and pathology staging system for invasive cutaneous melanoma is based upon the anatomic findings of the
melanoma; that is what the pathologist can see under the microscope from an initial tumor biopsy and what the physician can
feel or see during a clinical exam or upon imaging. While this staging system provides population-based risk of metastasis
estimates it does not evaluate nor incorporate the biology of the patient’s primary tumor.
Importantly, while it was formerly believed that the SLNB surgery improved melanoma specific survival, the landmark,
prospective, randomized multi-center study conducted by the National Cancer Institute, the MSLT-I study, showed that death
from melanoma was the same in patients who were randomized to the SLNB surgery or observation, indicating that the SLNB
surgery is prognostic, and not therapeutic, as it relates to the risk of death from melanoma. On average, 12% of patients
undergoing the SLNB surgery will have an SLN-positive biopsy result and 88% will not. The invasive SLNB surgery carries
significant healthcare burden. For instance, the overall complication rate of SLNB was shown to be 11.3% in a systematic
review of 21 articles representing 9,047 patients. A separate review reported that the regional false negative rate of the SLNB
surgery ranged from 5% to 21%, with a median rate of 18%. Regional false negative rate is defined as the rate that metastasis to
the regional lymph node in patients with a negative SLNB surgical result.
Both the complication and false negative rates are above the recommended 5% and 10% thresholds proposed by guideline
committees. Further, the SLNB surgery requires the use of general anesthesia and nearly half of the surgeries are performed in
an in-patient setting, leading to an average reimbursed cost of $20,000 to $24,000. Finally, the 88% SLN-negative rate carries
significant patient and healthcare system implications. This means that 88% of the time, patients undergoing an SLNB will have
no change in their treatment plan and no change in their staging but are still exposed to the complications from the surgery,
including general anesthesia risks, cost and a median false negative rate of 18%. Thus, while it is true that patients who are SLN
positive, or re-staged to Stage III, have a higher population-based rate of metastasis and death from melanoma, the SLNB
surgery does not improve melanoma-specific survival, carries risk of complications, a high false negative rate and significant
costs.
In addition to the significant clinical issues involved in only using the traditional clinical and pathology factors to determine
SLNB eligibility, a discordance exists between an individual’s stage and their risk of metastasis or death from melanoma. Based
on data from SEER and the American Joint Committee on Cancer, or AJCC, of the patients diagnosed with Stage I, II or III
cutaneous melanoma, 80% of melanomas are classified as the lowest risk, Stage I, and 12% are classified as next lowest risk,
Stage II. However, these data show that patients with melanomas that are initially diagnosed as Stage I or II represent 60% of
all deaths in patients initially diagnosed as Stage I, II or III. Furthermore, while patients with Stage III melanoma are at a higher
population risk of metastasis and death from melanoma, the five-year melanoma-specific survival rate for these patients is 77%.
The limitations of the current staging system not only result in unnecessary SLNB surgeries for certain low-risk patients, but we
believe also leads to overtreatment with adjuvant immune-oncology and targeted therapies for certain patients with Stage III
melanoma.
9
In summary, the risk of metastasis determines the treatment plans in newly diagnosed patients, including the recommendation
for the SLNB surgery, decisions around the initiation of advanced imaging for active surveillance, frequency and specialty for
clinical follow-up, initiation of adjuvant therapy and discussion of clinical trial enrollment opportunities. The top portion of the
graphic below summarizes decision points that DecisionDx-Melanoma impact. The lower portion summarizes the limitations of
solely relying upon risk of metastasis based upon clinical and pathology features alone as it relates to SLNB surgery and the
subsequent treatment plan decisions.
Source: AJCC v7 J Clin Oncol 2009; SEER data release 2017; Morton et al. N Engl J Med 2014; Whiteman et al. J Invest Dermatol 2015; Shaikh et al. J Natl Cancer Inst 2016; Poklepovic and Carvajal. Oncology
2018; Sondak and Zager. Ann Surg Oncol 2010. Moody et al. Euro Jrnl Surg Onc 2017.
Cutaneous Squamous Cell Carcinoma
Identifying high risk SCC presents challenges for physicians. Unlike in cutaneous melanoma, where longitudinal databases
were developed in an attempt to align population-based risk of metastasis with clinical and pathology factors, the same level of
effort has not been given to SCC. There have been as many as three SCC staging systems in the United States, each with widely
divergent classifications for high- and low-risk patients. For example, a 2014 study compared the AJCC version 7 and National
Comprehensive Cancer Network, or NCCN, systems to assess concordance between the AJCC and NCCN systems. The AJCC
system classified 82% as low risk while the NCCN system classified 13% as low risk. As such, this level of discordance results
in the risk assessment staging systems minimally impacting treatment plans, with patients frequently being over- and under-
treated.
Today, in addition to NCCN high-risk criteria, there are two principal staging systems for SCC: the AJCC version 8 (which is
limited to head and neck SCC) and the Brigham Women’s Hospital, or BWH, version. All three systems rely upon a
combination of clinical or pathology factors to stage or classify risk of metastasis. In general, NCCN identifies the majority of
patients who do go on to metastasize, but it suffers from the lowest PPV of the three systems. Our initial clinical validation
study of 321 patients was focused on patients with one or more high-risk features. Within this study, NCCN demonstrated a
sensitivity of 96% while PPV was 7% and NPV was 90.5%. The low PPV means that 93 out of 100 NCCN high risk SCC’s did
not actually metastasize. AJCC and BWH demonstrated a sensitivity of 38.5% and 25%, respectively, PPV of 33% and 35%,
10
respectively and NPV of 88% and 86%, respectively. If one relies just upon NCCN, the low PPV means that developing an
adjuvant treatment plan that includes radiation, or chemotherapy or complete lymph surgical dissection, or a combination of
these, for a high-risk patient may be appropriate for the one out of fourteen high-risk patients who will metastasize but not for
the remaining thirteen patients who would not have metastasized. For AJCC and BWH, the PPV does improve but it also means
that two out of three patients would be recommended for an adjuvant treatment plan who will not benefit. These accuracy
metrics have created significant discordance in the approach to managing patients with high-risk features, from one end of the
spectrum being intervention for all high-risk patients to “watch and wait” for all high-risk patients. The end result is an
unacceptable clinical discordance in the approach to treatment plans and significant over- and under-treatment for a diagnosis
that leads to the most skin cancer deaths in the United States.
Suspicious Pigmented Lesions
A pigmented lesion biopsy that is difficult to diagnose may lead to an indeterminate diagnosis, in which case the treating
physician generally leans towards making a conservative decision and assumes that the lesion is melanoma. A definitive
diagnosis of invasive cutaneous melanoma results in a treatment plan that involves wider margins for the definitive wide local
excision surgery, consideration of the SLNB surgery and post-diagnosis management plans, including frequent, high intensity
surveillance using advanced imaging, frequent clinical visits and encouragement to enroll in clinical studies. If the
indeterminate lesion was benign, then the recommendation in the majority of cases would be no additional intervention. Thus,
the tendency of physicians to treat an indeterminate diagnosis as melanoma leads to significant over-treatment decisions,
complications and increased healthcare costs.
Uveal Melanoma
Approximately 97% of patients with uveal melanoma have no evidence of metastatic disease at the time of diagnosis and the
success rate for definitive treatment of the primary tumor surpasses 90%. However, within three years, approximately 30% of
all patients will experience metastases. Prior to commercial availability of DecisionDx-UM, other clinical staging and
molecular diagnostic tests existed for uveal melanoma, but the lack of prospective studies, coupled with low accuracy, resulted
in these tests primarily being used for research purposes rather than for clinical management of patients in the United States. As
a result, nearly all U.S. centers grouped patients into a single, high-risk treatment plan that included frequent, high intensity
surveillance using advanced imaging, frequent clinical visits and encouragement to enroll in clinical studies.
Our Solution
We use the gene expression profile of an individual patient’s tumor biology to inform specific prognosis of metastasis or
recurrence and aid the decision-making process of the treating physician and their patient to help optimize health outcomes and
reduce healthcare costs. Due to the biological complexity of skin cancer, developing accurate products takes scientific
diligence, stringent clinical protocols, machine learning expertise, proprietary algorithms and significant investments of time
and capital. In addition, the underlying tissue samples and associated outcomes data required to develop and validate these
products are difficult to obtain. Once successfully developed and validated, commercial success requires the generation of
ongoing evidence such as clinical use documentation to support appropriate physician adoption, reimbursement success and
guideline inclusion.
We currently market three proprietary dermatologic products: DecisionDx-Melanoma, DecisionDx-SCC and DecisionDx
DiffDx-Melanoma. We also market DecisionDx-UM, a proprietary GEP test designed to identify the risk of metastasis in
patients diagnosed with uveal melanoma. Multiple studies for our products have been published since completion of the initial
clinical validation studies and have confirmed the accuracy of our products. Also, multiple clinical impact studies have
demonstrated a significant impact on physician decisions to alter their treatment plan when the results of our test are considered
in concert with the traditional clinical and pathology factors. DecisionDx-Melanoma and DecisionDx-UM are currently
reimbursed by Medicare under positive coverage policies. In addition, we have received widespread positive private payor
coverage and positive guideline inclusion for DecisionDx-UM, our first melanoma test. Since our inception, we have processed
more than 70,000 clinical patient samples.
Our products are designed to provide the following benefits:
•
Clinically Actionable Information for Physicians. We provide physicians and their patients with a report that contains
clinically actionable information to inform the treatment plan for each individual patient. Our reports are updated as
new clinical data is generated that may enable additional clinical decisions to be made. Based on four studies that we
have conducted on clinical actionability of our DecisionDx-Melanoma test, utilizing the results of our test reports,
physicians changed a patient’s treatment in approximately 50% of cases, indicating physician confidence in the
evidence underlying our reports.
11
•
•
Informed Patient Care. The clinical evidence shows that our products are accurate predictors of a patient’s specific
risk of metastasis or recurrence of their cancer based upon the gene expression profile of their tumor, independent of
available clinical and pathology factors. Physicians use this information to identify patients who are likely to benefit
from an escalation of care as well as those who may avoid unnecessary treatments, such as medical and surgical
interventions.
Reduced Healthcare Costs for Payors. We believe our products have the potential to reduce overall healthcare costs
by enabling physicians and their patients to avoid unnecessary medical and surgical interventions, including the SLNB
surgery. As an example, without DecisionDx-Melanoma, 88% of patients who receive the SLNB surgery, which has
an average in-patient reimbursed cost of $20,000 to $24,000, are found to be SLN-negative and remain classified as
low risk. If all patients eligible for the SLNB surgery were tested and their test results were acted upon, we estimate
the potential savings to the U.S. healthcare system could be up to $250 million, after considering the cost of
DecisionDx-Melanoma.
Our Products
We currently market three proprietary dermatologic products, DecisionDx-Melanoma, DecisionDx-SCC and DecisionDx
DiffDx-Melanoma. We also market DecisionDx-UM, a proprietary GEP test designed to identify the risk of metastasis in
patients diagnosed with uveal melanoma. Together, we believe these four commercial products support an estimated total
addressable market of $2.0 billion in the United States. We have received positive local coverage determinations, or LCDs,
providing Medicare coverage for DecisionDx-Melanoma and DecisionDx-UM. These LCDs facilitate reimbursement from
Medicare, which represents approximately 50% of the addressable patient population. We also have third-party payor coverage
for over 100 million lives for DecisionDx-UM and over 21 million lives for DecisionDx-Melanoma.
DecisionDx-Melanoma
Overview
We developed and market DecisionDx-Melanoma to healthcare providers for use with patients diagnosed with invasive
cutaneous melanoma. Without the use of DecisionDx-Melanoma, these patients are classified in low- and high-risk categories
based on population-wide clinical and pathology features, which impact a physician’s treatment plan recommendations,
including whether or not to offer the invasive SLNB surgery, frequency and use of clinical imaging and follow-up frequency,
adjuvant therapy and clinical trial enrollment. Unfortunately, these clinical and pathology features do not incorporate the
genomics of an individual patient’s tumor biology, which often leads to a misclassification of a patient’s risk of metastasis or
recurrence.
To address this need for a more accurate predictor of metastatic risk, we discovered, developed and completed validation for
DecisionDx-Melanoma. This product is designed to help physicians identify high-risk patients with Stage I and II melanomas
based on biological information, or expression, from 31 genes within their tumor tissue. DecisionDx-Melanoma does not
change a physician’s standard diagnostic workflow for suspicious pigmented lesions, which includes performing the initial
biopsy procedure and placing the biopsied tissue in formalin. The dermatopathologist then embeds the specimen in a paraffin
block, cuts sections that are stained for viewing under a microscope and makes a diagnosis of invasive melanoma. We then
extract and purify RNA from sections of the remaining specimen to run our test. We report test results in two classes and two
subclasses. Class 1A represents the lowest risk group, Class 1B/2A represents an increased risk group and Class 2B represents
the highest risk group.
In March 2021, we announced that DecisionDx-Melanoma now utilizes an Integrated Test Result, or ITR, designed to provide
more precise risk prediction in patients with Stage I, II or III melanoma. The ITR is calculated by an independently validated
algorithm (i31-GEP), designed to provide a more precise and personalized prediction of SLN positivity in order to guide
discussions and recommendations, within current risk-based guidelines, for the SLNB surgical procedure. i31-GEP is an
artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively
tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s
traditional clinicopathologic features. We expect to launch an app based on i31-GEP and the ITR later in 2021.
Clinical Validation
We have published 13 clinical validation studies of DecisionDx-Melanoma, which we believe is the largest clinical validation
program of the metastatic risk of cutaneous melanoma ever conducted. Based on our published data, we have shown that
12
DecisionDx-Melanoma is an accurate independent predictor of the risk of metastasis or recurrence, showing an aggregate
melanoma-specific five-year survival rate of 99% for patients who receive the Class 1A test result.
Our first study, published in January 2015, analyzed 104 patients with Stage I, II and III melanoma from an independent cohort
with long term outcomes data. This study reported a five-year disease-free survival rate of 98% for patients with Stage I and II
melanoma who received a Class 1 test result. In addition, the study also reported that only 2% of patients with a Class 1 test
result were SLN-positive.
Our January 2019 study published in the Journal of the American Academy of Dermatology reviewed data on 690 patients with
Stage I, II and III melanoma from all three previously published long-term archival publications, and enabled analysis of
clinically important subgroups. Overall, the study reported a five-year melanoma specific survival rate of 99% for patients with
Stage I, II or III melanoma who received a Class 1A test result.
Our long-term outcomes study data shows that we can provide a more specific individual risk of metastasis and death from
melanoma that is distinct from the AJCC stage approach that limits prediction to clinical and pathology factors. The only
endpoint reported by the AJCC is death from melanoma. For patients diagnosed with Stage I melanoma, DecisionDx-
Melanoma predominantly identifies patients with a risk of death from melanoma that is similar to a patient with Stage IIIA
melanoma, with the remaining group having a 99.6% likelihood of being alive from melanoma at five years. For patients with
an intermediate risk Stage II melanoma, DecisionDx-Melanoma can distinguish between patients who have a very low risk of
death from melanoma (>99% likelihood of being alive at 5-years) from those who have a higher risk of death from melanoma
that is similar to a patient with Stage IIIA/IIIB melanoma. For patients with a Stage III melanoma, DecisionDx-Melanoma can
identify patients who have a likelihood of death from melanoma similar to a patient with Stage IIA melanoma, with the
remainder having a risk similar to a patient with Stage IIIC melanoma.
The ability of DecisionDx-Melanoma to improve the risk of recurrence or risk of death from melanoma accuracy of these
patient populations is clinically significant as NCCN guidelines recommend that the duration and frequency of follow-up and
intensity of cross-sectional imaging be based on a patient’s individual conditional probability of recurrence. The NCCN
guideline cut-point for these decisions is between Stage I-IIA versus Stage IIB-III. For example, the chart below demonstrates
that a patient with a Stage I melanoma but a DecisionDx-Melanoma Class 2B test result has a melanoma specific survival rate
of 89.5%, which is a higher risk than if the patient had a Stage IIIA melanoma. Today, patients with a Stage III melanoma are
recommended to have an increased follow-up schedule, undergo routine cross-sectional imaging, consider initiation of adjuvant
therapy, such as an anti-PD1 inhibitor, and consider enrollment in a clinical trial. None of these options would be considered in
a patient with a Stage I melanoma in the absence of a DecisionDx-Melanoma test result.
The first prospective, multi-center study of 322 patients with Stage I, II and III melanoma was published in August 2017. This
interim analysis reported a recurrence free survival rate of 97% and overall survival rate of 99% for patients with Stage I, II and
III melanoma who received a Class 1 test result.
The most recent, independent, prospective, multi-center study of 86 patients with Stage IB and II melanoma was published in
February 2019 in the Journal of The European Academy of Dermatology and Venereology. This study reported a recurrence
13
free survival rate of 100% for patients with Stage IB and II melanoma who received a DecisionDx-Melanoma Class 1 test
result.
An independent, prospective, single-center study of 159 patients with Stage I, II and III melanoma was published in March
2019 in Cancer Medicine. Of patients who recurred, the median time to recurrence was 13 months. Of patients who did not
recur, the median follow-up time was 45 months. This study reported that the DecisionDx-Melanoma test was an independent
predictor of recurrence (p=0.0001) and the most significant predictor of recurrence with a hazard ratio of 9.2 compared to
hazard ratio of 3.5 for SLNB status and 1.2 for Breslow thickness. The DecisionDx-Melanoma test was also an independent
predictor for distant metastasis and the most significant with a hazard ratio of 19.0 compared to 3.75 for SLNB status (Breslow
thickness was not statistically independent). NPV for Class 1 for distant metastasis-free survival was 99%.
When evaluating DecisionDx-Melanoma, one of the most important criteria is whether the test adds new information that is
independent of the traditional clinical and pathology factors. The formal statistical method used to evaluate independence is the
Cox multivariate analysis. Outputs of the Cox multivariate analysis include statistical significance, measured by p-value, as well
as the power of the result, measured by Hazard Ratio, or HR. A p-value of less than 0.05 indicates statistical significance and
thus independence. If statistical significance is reached, then the HR indicates the power of the result, with a higher HR
indicating greater outcome prediction. For example, an HR of nine means that patients with a high-risk test result are nine times
more likely to experience metastasis or death than a low-risk test result. The table below shows the Cox multivariate analysis of
the disease-free survival, melanoma-specific survival and recurrence free survival from the four performance studies noted
above.
The American Academy of Dermatology and other organizations use the Strength of Recommendation Taxonomy, or SORT,
system to evaluate prognostic tests such as DecisionDx-Melanoma. The SORT system ranks evidence of clinical validity as
levels 1, 2 or 3, and assigns a strength of recommendation as levels A, B or C. A SORT level 1A is the highest level and 3C is
the lowest. For SORT ranking, “a systematic review or meta-analysis of good quality studies” or “a prospective study with
good follow-up” represents a level 1 for good quality evidence of clinical validity. For SORT strength of recommendation,
“consistent, good quality evidence” represents a level A recommendation. A systematic review and meta-analysis was
published in the Journal of the American Academy of Dermatology in 2020 in an article titled “Molecular risk prediction in
cutaneous melanoma: a meta-analysis of the 31-gene expression profile prognostic test in 1,479 patients.” This meta-analysis
reviewed multiple peer-reviewed published clinical validation studies of DecisionDx-Melanoma, including prospective studies.
The meta-analysis and the prospective studies satisfied the level 1 ranking of good quality studies and the consistency of
DecisionDx-Melanoma data across these studies satisfied the level A strength of recommendation. Thus, the authors concluded
that DecisionDx-Melanoma achieved a 1A level of evidence of clinical validity and strength of recommendation under the
14
SORT system. Furthermore, as shown below, the multi-variate analysis for recurrence-free survival found DecisionDx-
Melanoma to be the strongest predictor of risk of recurrence compared to the evaluable clinical and pathology factors.
In addition, we conducted a prospective, multi-center study of 1,421 patients, which was published in Future Oncology in
January 2019 which focused on the performance of DecisionDx-Melanoma to predict metastasis to the SLN. This study found
that patients with a Class 1A test result with melanomas less than or equal to 2.0 mm thick, which represents 86% of all
melanomas, have a 95% probability for an SLN-negative biopsy result. Analyzing this data by age shows that patients 65 years
of age or older have a 98% NPV, those between 64 and 55 years of age have a 95% NPV and patients under 55 years of age
have a 92% NPV. For physicians and patients evaluating whether to use DecisionDx-Melanoma to guide decision-making on
the SLNB surgery, the impact on melanoma specific survival is an important consideration if the SLN status is not known. To
address this, we analyzed the long-term outcome data from our Gastman 2019 publication and showed that patients of all ages
with a melanoma less than or equal to 2.0 mm thick and a Class 1A test result have a five-year melanoma specific survival rate
of 99.6%, while similar patients 55 years or older had a melanoma specific survival rate of 99.3%. This study showed that use
of DecisionDx-Melanoma for patients with melanomas of less than or equal to 2.0 mm thick could potentially result in 74%
fewer SLNB surgeries.
Clinical Utility
We completed and published four consecutive studies between September 2016 and March 2018 documenting how
DecisionDx-Melanoma impacts treatment plan decisions. Based on the results of our DecisionDx-Melanoma test reports,
physicians changed their treatment plan recommendations approximately 50% of the time. This change in the management of
patient treatment plan recommendations compares favorably to leading molecular diagnostic tests as well as to the SLNB
surgery, which only changes clinical decision-making approximately 12% of the time.
Study
Berger et al. CMRO 2016
Design
# of Patients
% Change in
Management
Prospectively tested cohort, multi-center. Retrospective pre
test / post test management.
Dillon et al. SKIN J Cutan Med 2018
Prospective, multi-center: pre test / post test management.
Farberg et al. J Drugs Derm 2017
Schuitevoerder et al. J Drugs Derm 2018
169 physician impact study: patient vignettes with pre test /
post test management.
Prospectively tested cohort, single center. Retrospective
pre test / post test management; and modeling of
prospective cohort.
156
247
n/a
91
53%
49%
47-50%
52%
Building on our clinical utility evidence, in October 2020, the publication in Future Oncology of a retrospective study, titled
“Integrating the melanoma 31-gene expression profile test to surgical oncology practice within national guideline and staging
recommendations,” shows that DecisionDx-Melanoma impacted management decisions for patients diagnosed with AJCC 7th
edition stage I – III melanoma. Study authors developed a recommended melanoma patient care algorithm that incorporates
DecisionDx-Melanoma to help inform frequency and duration of follow-up visits, blood work and surveillance imaging in line
with predicted metastatic risk. Patients’ DecisionDx-Melanoma test result was found to have an impact on the number and
duration of follow-up and surveillance visits, and patients assessed as having a high risk of metastasis (designated by a
DecisionDx-Melanoma Class 2 test result) received more intensive management than patients assessed as having a low risk
15
(designated by a DecisionDx-Melanoma Class 1 test result). Clinicians using the test were shown to adjust patient management
in a risk-appropriate direction, within recommendations of national guidelines.
These studies illustrate how physicians use DecisionDx-Melanoma to inform the treatment pathway for patients who have been
diagnosed with invasive cutaneous melanoma. Our DecisionDx-Melanoma test informs two initial treatment decisions: (1) to
determine whether to offer and recommend the SLNB surgery to patients with melanomas less than or equal to 2.0 mm thick,
and (2) following this decision, to guide the appropriate post-SLNB surgery treatment plan for their patients, including
decision-making regarding advanced imaging, frequency of clinical visits, referral to medical oncology, adjuvant therapy,
clinical trial enrollment, and watchful waiting.
Health Economics
We believe that the use of DecisionDx-Melanoma can reduce the number of SLNB surgeries, which has an average in-person
reimbursed cost of between $20,000 and $24,000, thereby reducing overall cost of patient treatment for invasive cutaneous
melanoma. If all patients eligible for the SLNB surgery were tested and their test results were acted upon, we estimate the
potential savings to the U.S. healthcare system could be up to $250 million, after considering the cost of DecisionDx-
Melanoma.
In addition, DecisionDx-Melanoma can be used to make more informed decisions on advanced imaging, frequency of clinical
visits, referral to medical oncology, adjuvant therapy initiation and clinical trial enrollment. In some cases, the DecisionDx-
Melanoma test result may guide an appropriate reduction in these decisions based upon a low risk of metastasis and in others it
will guide an appropriate increase with the end result being improved use of healthcare resources.
The American Medical Association’s, or the AMA’s, Current Procedural Terminology Editorial Panel accepted Castle’s
application for a Category I Multianalyte Assays with Algorithmic Analyses, or MAAA, Current Procedural Terminology, or
CPT, code for its DecisionDx-Melanoma test. The CPT Editorial Panel is an independent group of expert volunteers
representing various sectors of the health care industry. Its role is to ensure that code changes undergo evidence-based review
and meet specific criteria. The code became effective on January 1, 2021. With this acceptance, two of our proprietary MAAA
tests, DecisionDx-Melanoma and DecisionDx-UM, have met the criteria required for a Category I MAAA CPT code.
DecisionDx-SCC
The current treatment pathway for patients identified as having high-risk SCC suffers from a low PPV for risk of metastasis or
recurrence. As a result, many patients categorized as high risk received adjuvant therapy and other unnecessary medical and
surgical interventions even though they would not have gone on to metastasize. Conversely, there are also many patients
categorized as high risk who are placed in “watchful waiting” who could benefit from adjuvant therapy.
To address this clinical need in SCC, we developed DecisionDx-SCC, a proprietary 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of squamous cell carcinoma metastasis for patients with one or
more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual
metastatic risk to inform risk-appropriate management. The test is designed to provide a better PPV while maintaining similar
NPV. We commercially launched DecisionDx-SCC on August 31, 2020. Four peer-reviewed publications have demonstrated
that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician decisions regarding staging and management.
In 2020, development and validation data was published in the Journal of the American Academy of Dermatology in an article
titled “Validation of a 40-Gene Expression Profile Test to Predict Metastatic Risk in Localized High-Risk Cutaneous Squamous
Cell Carcinoma.” The study findings indicate that DecisionDx-SCC demonstrated strong independent prognostic value in
multivariate analysis compared to the BWH and AJCC v8 staging systems. We have ongoing multi-center studies involving
more than 75 U.S. centers.
16
DecisionDx DiffDx-Melanoma
Of the two million suspicious pigmented lesions biopsied annually in the U.S., we estimate that approximately 300,000 of those
cannot confidently be classified as either benign or malignant through traditional histopathology methods. A biopsy of a
pigmented lesion may lead to an indeterminate diagnosis, in which case the treating physician generally leans towards making a
conservative decision and assumes that the lesion is melanoma.
To address this clinical need, we developed DecisionDx DiffDx-Melanoma, a proprietary GEP test designed to be used as an
adjunct to histopathology when the distinction between a benign lesion and melanoma is uncertain. We commercially launched
this product on November 2, 2020. DiffDx-Melanoma classifies these lesions as benign (gene expression profile suggestive of
benign neoplasm); intermediate-risk (gene express profile cannot exclude malignancy); or malignant (gene expression profile
suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DiffDx-
Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver
more informed patient management plans. Validation of this test included a variety of benign and malignant lesions.
In 2020, two studies were published in SKIN: The Journal of Cutaneous Medicine. The development and validation study,
“Development and Validation of a Diagnostic 35-Gene Expression Profile Test for Ambiguous or Difficult-To-Diagnose
Suspicious Pigmented Skin Lesions,” showed that the DiffDx-Melanoma test had a technical success rate of 97%, meaning that
a test result was successfully generated, and achieved accuracy metrics that could alleviate uncertainty in difficult-to-diagnose
lesions leading to decreased unnecessary procedures while appropriately identifying at-risk patients. The clinical utility study,
“A 35-Gene Expression Profile Test for Use in Suspicious Pigmented Lesions Impacts Clinical Management Decisions of
Dermatopathologists and Dermatologists,” concluded that the diagnosis of challenging melanocytic neoplasms and subsequent
clinical management decisions were influenced by DiffDx-Melanoma results in alignment with the test result. The utility of the
test may provide the opportunity for clinicians to deliver more informed patient management plans.
DecisionDx-UM
Overview
At the time of diagnosis nearly all patients with uveal melanoma have no evidence of metastasis yet approximately 30% of
uveal melanoma goes on to metastasize within three years and nearly 50% of uveal melanoma goes on to metastasize, overall.
Traditional clinical staging and molecular diagnostic tests exist for uveal melanoma, but the lack of prospective studies of these
tests, coupled with low accuracy, has resulted in these tests primarily being used for research purposes rather than for clinical
management of patients in the United States. As a result, nearly all U.S. centers group patients into a single, high-risk treatment
plan that included frequent, high intensity surveillance using advanced imaging, frequent clinical visits and encouragement to
enroll in clinical studies.
DecisionDx-UM is a proprietary GEP test that helps healthcare providers predict the risk of metastasis in patients with uveal
melanoma. We licensed the intellectual property for DecisionDx-UM from The Washington University in St. Louis, Missouri,
or WUSTL, completed analytical validation and began marketing DecisionDx-UM in late 2009 for use in patients diagnosed
with uveal melanoma without evidence of metastatic disease. DecisionDx-UM identifies which patients are at low risk for
progression of their disease so that their physicians can appropriately de-escalate the level of care provided. DecisionDx-UM is
delivered to approximately 1,500 patients annually, representing approximately 92% of the patients diagnosed in the United
States.
Sixteen peer-reviewed publications supporting the clinical validity and utility of DecisionDx-UM have been conducted.
The Kaplan-Meier plot from the initial prospective, multi-center Collaborative Ocular Oncology Group, or COOG, study found
a 97% NPV for risk of metastasis. This study also compared DecisionDx-UM to the traditional clinical and pathology factors as
well as chromosome 3 status, which is an alternative molecular test to predict the risk of metastasis in uveal melanoma. As is
shown in the Cox multivariate analysis, the only statistically significant factor in predicting a likelihood of metastasis was
DecisionDx-UM.
17
The data from the COOG study, as well as the consistency shown from the additional clinical validity studies, has supported
wide-spread adoption of DecisionDx-UM with more than 90% of the ocular oncology institutions in the United States ordering
this test.
DecisionDx-UM has been used to guide treatment plan decisions regarding the intensity of a patient’s surveillance and
management plan as well as clinical trial enrollment.
The current NCCN Guidelines for Uveal Melanoma (last updated January 2021) incorporate DecisionDx-UM as the first risk of
distant metastasis predictor to guide systemic imaging.
Development Engine and Pipeline
We identify areas of significant unmet medical needs in the treatment of dermatologic diseases and leverage our expertise in
genomics, data analytics and artificial intelligence to develop clinically actionable products. We focus first on previously
unanswered medical questions, which we often identify as the result of the in-depth conversations our sales and medical affairs
representatives have with physicians. We leverage our deep understanding of dermatologic diseases and clinical treatment
pathways to identify areas of unmet medical need where better information can improve, and potentially transform, patient
outcomes. Next, our team of scientists and laboratory technologists use the latest genomic methods to discover RNA-based
gene expression profiles that are likely to impact treatment pathway decisions. Our bioinformatics team works collaboratively
with our scientists to build proprietary algorithms based on machine-learning techniques to predict the risk of metastasis or
recurrence based on the genomics of each individual patient’s tumor biology.
Once we have generated a product candidate that we believe will address an unmet medical need, we work to validate the
product candidate through extensive testing of patient tissue samples combined with clinical outcomes data. We use both our
extensive data bank of patient tumor samples and clinical outcomes data to run development and validation studies and conduct
clinical studies to collect new samples in additional diseases. We publish our data regularly to drive adoption, reimbursement
and guideline inclusion.
We have significant expertise in developing proprietary algorithms, conducting clinical studies and using the necessary
instrumentation required for efficiently developing our pipeline products. We have initiated work on a number of pipeline tests
which branch out upstream, downstream and parallel to our currently marketed tests. Although we are still in the early stages of
development, we believe we could launch three to five new tests by the end of 2025, utilizing our existing sales channels,
18
potentially adding approximately $3.6 billion to our current U.S. TAM. We expect to provide additional details on these
pipeline products before the end of 2021.
Our Commercial Channel
Sales and Marketing
Our sales and marketing efforts are currently focused on the United States skin cancer market. We employ a direct sales and
marketing strategy to educate dermatologists, surgeons and other physicians on the clinical and economic benefits of our
products. Our sales approach is highly technical, and our team is trained to articulate the scientific and clinical evidence behind
our products and how they influence the clinical care pathway and ultimately improve patient outcomes. Our sales force is
focused on educating and informing the entire patient care team, which consists of treating clinicians, nurses, laboratory and
pathology personnel, and finance administrators, on the appropriate use and value of our tests.
In December 2018, our customer-facing commercial and medical affairs group was staffed in the low 20s. We successfully
executed two expansions (in the first quarter of 2019 and in December 2019) bringing the total to the low 50s. Our customer-
facing team is focused on leading high clinical impact discussions with the treating clinician’s areas of interest, including
clinical utility, patient outcomes, and supporting evidence. We saw significant promotion responsiveness in 2019.
We increased our outside sales territories from 14 to 23 in the first quarter of 2019 and also added supporting inside sales
associates, medical affairs and marketing staff. We believed that this increase in customer-facing personnel would increase the
adoption of our products as we would be able to educate more physicians on the clinical benefits of our products. We did see
the promotion responsiveness that we anticipated and conducted a second expansion in December 2019 that brought our outside
sales territories to 32. In the third quarter of 2020, we expanded our commercial team to create a dedicated sales force of ten
territories to support the launch of our DecisionDx DiffDx-Melanoma test to dermatopathologists, while our existing sales team
remains focused on DecisionDx-Melanoma and DecisionDx-SCC. We ultimately believe that our DecisionDx DiffDx-
Melanoma test will be ordered by both dermatopathologists and dermatologists. Thus, it is our intention, to fold this new
dedicated team into the existing sales team as well as further expand in the first half of 2021 bringing us to approximately 60
outside sales territories. However, we will also continue to evaluate our mix of outside sales territories, inside sales support,
marketing and medical affairs in the context of our dermatologic tests and adjust our investments based upon these evaluations.
DecisionDx-UM addresses a small cancer market, and patients are managed by a small group of ocular oncology surgeons,
generally ophthalmology or retina trained specialists. We serve these patients and their physicians by providing highly technical
interactions that focus on optimizing the appropriate use of our proprietary and ancillary products.
Medical Affairs
We also deploy an experienced medical affairs group to assist education of treating physicians and key opinion leaders, to
identify and engage sites for our sponsored clinical studies and to evaluate collaborative study opportunities. Our medical
affairs strategy complements our sales and marketing and clinical research operations efforts.
Reimbursement
The primary source of revenue for our products is reimbursement from third-party payors, which includes government payors,
such as Medicare, and commercial payors, such as insurance companies. Achieving broad coverage and reimbursement of our
current products by third-party payors and continued Medicare coverage are key components of our financial success. De novo
coverage by government and third-party payors for our pipeline tests will be important over time.
Government Payors
Medicare coverage is limited to items and services that are within the scope of a Medicare benefit category and that are
reasonable and necessary for the diagnosis or treatment of an illness or injury. LCDs are made through an evidence-based
process by Medicare Administrative Contractors, or MACs, with opportunities for public participation.
Palmetto GBA MolDX, or Palmetto, the MAC responsible for administering MolDX, the program that assesses molecular
diagnostic technologies, issued a final LCD for DecisionDx-Melanoma, which became effective on December 3, 2018.
Noridian Healthcare Solutions, LLC, or Noridian, the MAC responsible for administering claims for laboratory services
performed in Arizona, adopted the same coverage policy as Palmetto on that date, and subsequently issued a final LCD on
February 10, 2019. This LCD provided for coverage for patients who are eligible for the SLNB surgery with cutaneous
melanoma tumors of 2.0 mm in thickness or less, and patients with clinically negative SLN basins who are being considered for
the SLNB surgery to determine eligibility for adjuvant therapy. Melanomas less than or equal to 2.0 mm thick represent 86% of
all melanomas. The median age at diagnosis is 63 years old, therefore the Medicare eligible population represents close to 50%
of the addressable market.
19
Palmetto issued a final expanded LCD for DecisionDx-Melanoma, effective November 22, 2020. With this expanded LCD and
the accompanying billing and coding articles, we estimate that a significant majority of the DecisionDx-Melanoma tests
performed for Medicare patients will meet the coverage criteria. Noridian has adopted the same coverage policy as Palmetto
and also issued an expanded final LCD for DecisionDx-Melanoma effective December 6, 2020.
Separately, Palmetto issued a final LCD for DecisionDx-UM, which became effective in July 2017, and Noridian issued a
similar LCD that became effective in September 2017. The Noridian LCD provides for coverage to determine metastatic risk in
connection with the management of a patient’s newly diagnosed uveal melanoma and to guide surveillance and referral to
medical oncology for those patients. Similar to cutaneous melanoma the median age at diagnosis for uveal melanoma is
estimated at 58-62 years old, therefore the Medicare eligible population represents close to 45% of the addressable market.
On May 17, 2019, CMS determined that DecisionDx-UM meets the criteria for “existing advanced diagnostic laboratory test”
status, also referred to as “existing ADLT” status. Accordingly, in 2021 the DecisionDx-UM Medicare rate will be set annually
based upon the median private payor rate for the first half of the second preceding calendar year. Note that our rate for 2020
was set by Noridian, our local MAC, but our rate for 2021 for DecisionDx-UM will be $7,776 based on the median private
payor rate. Also, on May 17, 2019, CMS determined that DecisionDx-Melanoma meets the criteria for “new ADLT” status.
Accordingly, from July 1, 2019 through March 31, 2020, the Medicare reimbursement rate was equal to the initial list price of
$7,193. From April 1, 2020 through December 31, 2021, CMS notified us that the rate will also be $7,193, which was
calculated based upon the median private payor rate for DecisionDx-Melanoma from July 1, 2019 to November 30, 2019.
Beginning in 2022, the rate for both DecisionDx-Melanoma and DecisionDx-UM will be set annually based upon the median
private payor rate for the first half of the second preceding calendar year. For example, the rate for 2022 will be set using
median private payor rate data from January 1, 2020 to June 30, 2020.
In the second quarter of 2020, we submitted our technical assessment dossier for DecisionDx-SCC to Palmetto and Noridian. In
early 2021, we submitted our technical assessment dossier for DecisionDx DiffDx-Melanoma. We expect that draft LCDs for
each of these tests will be posted in 2021. However, there is no assurance that the timing of any draft LCD or final LCD will
match our expectations or our historical experience with LCDs for our other tests.
Commercial Third-Party Payors
We are actively engaged in efforts to achieve broad coverage and reimbursement for our products, followed by contracting with
commercial payors. Achieving positive coverage reduces the need for appeals and reduces failures to collect from the patient’s
commercial payor. Even with positive coverage decisions, we still experience delays in time to payment. Achieving in-network
contracts with third-party payors can shorten the time required to receive payments. Implementing our strategy includes our
managed care and medical affairs teams educating third-party payors regarding our strong clinical utility and outcomes data,
which we believe validates the value of our products and will persuade more third-party payors to provide value-based
reimbursement.
We have broad positive policy coverage for our DecisionDx-UM test, we have executed contracts with certain commercial
payors and anticipate further increases in contracting. We also have positive policy recommendations from many third-party
technical assessment review groups.
We began, following the Medicare LCD, engaging commercial third-party payors for positive coverage for DecisionDx-
Melanoma and have seen some positive coverage policies. With the continued evidence development, we anticipate additional
positive coverage policies occurring.
Dependence on Third-Party Payors
We receive a substantial portion of our revenue from a small number of third-party payors, primarily Medicare, BlueCross
BlueShield affiliates and Medicare Advantage plans. Our revenue from patients covered by Medicare, Medicare Advantage
plans, and BlueCross BlueShield plans, as a percentage of total revenue, was 58%, 29% and 6%, respectively, for the year
ended December 31, 2020. BlueCross BlueShield plans and Medicare Advantage plans represent an aggregation of multiple
payors making independent reimbursement decisions; however, these plans often base reimbursement decisions on common
guidelines which can influence multiple plans simultaneously.
Competition
We are focused on providing high value diagnostic and prognostic solutions for dermatological cancers. We believe, today, that
there is limited existing competition for our products that provide evidence-based genomic solutions to physicians and their
patients.
20
We believe the principal competitive factors in our target markets include:
•
•
Proprietary, disciplined approach to genomic analysis including the use of proprietary deep learning, machine learning,
artificial intelligence and other techniques to identify and optimize gene selection and algorithmic approaches to
answer the clinically important questions with accurate tests. This involves the ability to design and efficiently conduct
the right clinical studies at the right time;
Research and development investments to document the quality, quantity, consistency and strength of the clinical
validity data, the impact our products have on clinical use, and demonstration of net health outcome improvement that
reduce health system costs;
• Maintaining a strong reputation with the treating physician by providing consistent, transparent, clinically relevant
information that will improve the appropriate management of their patients;
•
Ease of use in accessing our products, reimbursement support for the physician and their patient and laboratory reports
that clearly communicate the clinically relevant data points;
• Demonstrated ability to work with, and secure coverage and reimbursement from, governmental and commercial
payors;
• Ability to efficiently commercialize pipeline products to the same customer base as our current products.
We believe we compete favorably on the factors described above.
Today, our principal competition for DecisionDx-Melanoma is existing traditional clinical and pathology staging criteria. While
some clinical and pathology criteria have changed over time, this approach has been the standard of care in the United States for
many years, and physicians may be unwilling to accept the validity of the published data and adopt our test until it has become
incorporated into national guidelines. In addition, we may, in the near future, face competition from a limited number of
companies who are working in this disease space, such as Neracare and SkylineDx.
We are unaware of late-stage work being performed to develop and validate a product that would compete with DecisionDx-
SCC. We believe that the current primary competitor for DecisionDx-SCC is existing traditional clinical and pathology staging
criteria.
We are aware of competitors that likely compete with our DecisionDx DiffDx-Melanoma, such as Myriad Genetics. We expect
our product to compete favorably with these competitors.
DecisionDx-UM competes with a subsidiary of LabCorp and several academic laboratories all of which have had tests available
for several years. To date, our data has demonstrated that DecisionDx-UM is clinically and statistically superior to these
products.
Laboratory Operations
The Laboratory Developed Tests, or LDTs, that we commercialize are conducted in our CAP accredited, CLIA-certified
primary facility in Phoenix, Arizona, which we moved into in April 2016. In 2020, we doubled our footprint to approximately
23,500 square feet by adding a new laboratory facility in close proximity to our primary facility to support our growth and
provide certain operational redundancy. In 2021, we further expanded this facility to include approximately 3,600 additional
square feet. We perform all laboratory procedures involved in our tests from receiving a requisition form to issuance of the final
test result in these facilities. Our prior capacity plan analysis indicated that we could process up to 60,000 proprietary GEP test
orders annually, with a single shift. We performed more than 18,000 proprietary GEP tests in 2020. We are able to provide our
proprietary DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx DiffDx-Melanoma and DecisionDx-UM products for
patients in all fifty states including those that require specific, additional, out-of-state lab licenses or qualifications such as New
York, California, Pennsylvania, Maryland, and Rhode Island. Upon receipt, orders and samples are processed through an
automated laboratory information management system which, in addition to tracking sample chain of custody, initiates and
tracks accessioning, sample eligibility, technical data generation, algorithmic analysis and results reporting. The majority of
samples are received as paraffin embedded sections from a formalin fixed tissue specimen.
Our laboratory facilities house all functions related to quality control and assurance, licensing, accreditation and regulatory
compliance. Our quality management program ensures the quality of our laboratory services and products through continuous
monitoring of a broad range of key performance indicators including technical, customer service and cybersecurity metrics.
Through this program, we promote a philosophy of continuous improvement based upon adherence to validated standards. Our
Phoenix facilities also house our clinical research operations and local information technology support.
21
Raw Materials and Suppliers
We procure reagents, equipment, chips/cards and other materials used to perform our tests from sole suppliers such as
ThermoFisher Scientific, Inc., and Qiagen, Inc. Some of these items are unique to these suppliers and vendors. While we have
developed alternate sourcing strategies for these materials and vendors and while we have experienced no business interruption
due to an inability to source these materials, we cannot be certain whether these strategies will be effective or whether
alternative sources will be available when we need them. If these suppliers can no longer provide us with the materials we need
to perform our test services, they do not meet our quality specifications, or we cannot obtain acceptable substitute materials, our
business would be negatively affected.
License Agreement with The Washington University
In November 2009, we entered into a license agreement, or the License Agreement, with WUSTL to license certain patent
rights and technical information from WUSTL for the development of melanoma products, or the Products, and services, or the
Services. The rights licensed under this agreement are used in DecisionDx-UM only.
Under the License Agreement, we obtain an exclusive, worldwide, royalty-bearing license to certain patent rights owned by
WUSTL, or the Patent Rights, and a non-exclusive, worldwide license to certain technical information and research property
owned by WUSTL, with the right to grant sublicenses under certain conditions, to develop the Products and Services. WUSTL
retains the right to use the Patent Rights for research purposes.
The Patent Rights that we license pursuant to the License Agreement have been generated through the use of U.S. government
funding and are therefore subject to certain federal regulations. See “Risk Factors—Risks Related to Intellectual Property—Our
in-licensed intellectual property has been discovered through government funded programs and thus may be subject to federal
regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies, and
compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S.
manufacturers.”
Under the License Agreement, we are required to use best efforts to carry out the activities under an agreed-upon development
plan, or the Development Plan, and meet any and all milestones set forth in the Development Plan. We are required to make
milestone payments to WUSTL upon successful completion of development and commercialization milestones as set forth in
the Development Plan. For each Product or Service that receives FDA approval, premarket approval or premarket notification,
we are obligated to make a milestone payment to WUSTL in the mid-four digits. For the issuance of the first U.S. patent and
the first foreign patent, we are obligated to make aggregate milestone payments to WUSTL in the low-five digits.
Under the License Agreement, we were obligated to pay WUSTL an initial license issue fee in the low-five digits. We are also
obligated to make royalty payments to WUSTL equal to (i) a percentage in the mid-single digits of our and any of our affiliates’
or sub-licensees’ net sales of Products and (ii) a percentage in the low-single digits of our and any of our affiliates’ or sub-
licensees’ revenue from Services. We are also obligated to make royalty payments to WUSTL in the low-to-mid single digit
percentage of net sales, with minimum royalty payments to WUSTL every six-month period following the first commercial
sale.
The term of the License Agreement will continue for ten years following the last-to-expire valid claim relating to the Patent
Rights, unless terminated earlier. WUSTL may terminate the License Agreement upon written notice in the event of (i) our
material breach if such breach remains uncured for 90 days, (ii) the exercise of certain rights by us with respect to the Patent
Rights and/or the licensed technical information outside the scope of the License Agreement, or (iii) for certain insolvency-
related events. We may terminate the License Agreement without cause upon written notice to WUSTL and payment of any
amount due to WUSTL under the License Agreement.
Intellectual Property
Our core technology for our products is related to methods and devices for analysis of genetic expression. Using this
technology, we are able to provide a more accurate prediction of a patient’s metastatic risk as compared to other methods. We
have secured and continue to pursue intellectual property rights globally, including through patent protection covering analysis
of metastasis in cutaneous melanoma, as well as treatment of cutaneous squamous cell carcinoma. We also rely on trademarks,
trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain
our proprietary position. For more information, please see “Risk Factors—Risks Related to Intellectual Property.”
22
Patents and Patent Applications
We have developed a global patent portfolio that as of December 31, 2020, is comprised as follows:
Commercial Focus
Owned Patent Families
Methods for predicting risk of metastasis in cutaneous melanoma
Methods of diagnosing and treating patients with pigmented skin lesions
Methods of diagnosing and treating patients with cutaneous squamous cell
carcinoma
Method of predicting risk for recurrence for soft tissue sarcoma
Licensed Portfolio from WUSTL
Method for predicting risk of metastasis
Compositions and methods for detecting cancer metastasis
Total
Number of Applications and Patents
United
States
International
Total
2
2
2
1
2
2
11
16
—
7
—
—
2
25
18
2
9
1
2
4
36
Included in the table above are five issued U.S. patents and 13 issued international patents. This global patent portfolio has
filing dates ranging from 2009 to 2020, and therefore are projected to expire between 2029 and 2040, subject to any patent term
extension or patent term adjustment that might be available in a particular jurisdiction. The owned and licensed families contain
issued patents and pending applications that relate to devices, systems, and methods for macromolecular analysis, and reflect
our active and ongoing research programs.
Individual patents extend for varying periods depending on the date of filing of the patent application or the date of patent
issuance and the legal term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed
applications in the United States are granted a term of 20 years from the earliest effective non-provisional filing date. In
addition, in certain instances, a patent term can be extended to recapture a period due to delay by the United States Patent and
Trademark Office, or USPTO, in issuing the patent as well as a portion of the term effectively lost as a result of the FDA
regulatory review period. However, as to the FDA component, the restoration period cannot be longer than five years and the
total patent term including the restoration period must not exceed 14 years following FDA approval. The duration of foreign
patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective
non-provisional filing date. However, the actual protection afforded by a patent varies on a product-by-product basis, from
country to country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of
regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the
patent.
Trademarks and Trade Secrets
As of the date of this Annual Report on Form 10-K, our U.S. trademark portfolio contained eight trademark registrations.
We rely upon trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop
and maintain our competitive position. We seek to protect our intellectual property and proprietary technology, in part, by
entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants,
corporate partners and, as applicable, our advisors. These agreements are designed to protect our proprietary information and, in
the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a
relationship with an employee or a third party. These agreements may be breached, and we may not have adequate remedies for
any breach. We additionally seek to preserve the integrity and confidentiality of our data and trade secrets, such as our
proprietary algorithms, by maintaining the physical security of our premises and physical and electronic security of our
information technology systems. While we have confidence in these individuals, organizations and systems, agreements or
security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may
otherwise become known or be independently discovered by competitors. To the extent that our commercial partners,
collaborators, employees and consultants use intellectual property owned by others in their work for us, disputes may arise as to
the rights in related or resulting know-how and inventions.
23
Government Regulation and Product Approval
Regulations
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
As a clinical reference laboratory, we are required to hold certain federal, state and local licenses, certifications and permits to
conduct our business. Under CLIA, we are required to hold a certificate applicable to the type of laboratory tests we perform
and to comply with standards applicable to our operations, including test processes, personnel, facilities administration,
equipment maintenance, recordkeeping, quality systems and proficiency testing. We must maintain CLIA compliance and
certification to be eligible to bill for diagnostic services provided to Medicare beneficiaries.
To renew our CLIA certificate, we are subject to survey and inspection every two years to assess compliance with program
standards. Because we are a College of American Pathologists, or CAP, accredited laboratory, CMS does not perform this
survey and inspection and relies on our CAP survey and inspection. We may also be subject to additional unannounced
inspections. The regulatory and compliance standards applicable to the testing we perform may change over time, and any such
changes could have a material effect on our business.
Penalties for non-compliance with CLIA requirements include suspension, limitation or revocation of the laboratory’s CLIA
certificate, as well as directed plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit or criminal
penalties.
State Laboratory Licensing
In addition to federal certification requirements of laboratories under CLIA, CLIA provides that states may adopt laboratory
regulations and licensure requirements that are more stringent than those under federal law. Such laws, among other things,
establish standards for the day-to-day operation of a clinical reference laboratory, including the training and skills required of
personnel and quality control. We currently provide laboratory services in all 50 states and maintain out-of-state laboratory
licenses in New York, California, Maryland, Pennsylvania and Rhode Island.
Multiple states require the licensure of out-of-state laboratories that accept specimens from those states. Because we receive
specimens from New York, our clinical reference laboratory is required to be licensed by New York, under New York laws and
regulations. New York law also mandates proficiency testing for laboratories licensed under New York state law, regardless of
whether such laboratories are located in New York. If a laboratory is out of compliance with New York statutory or regulatory
standards, the New York State Department of Health, or NYSDOH, may suspend, limit, revoke or annul the laboratory’s New
York license, censure the holder of the license, or assess civil money penalties. We have received formal approval from
NYSDOH to offer our proprietary DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-PRAME products in New York.
Additionally, we have been granted conditional permission by NYSDOH to offer our DecisionDx-SCC and DecisionDx
DiffDx-Melanoma tests in New York while our applications are under review. If we were to be found out of compliance with
New York laboratory requirements, we could be subject to such sanctions, which could harm our business.
Federal Oversight of Laboratory Developed Tests
The laws and regulations governing the marketing of diagnostic products are evolving, extremely complex, and in many
instances, there are no significant regulatory or judicial interpretations of these laws and regulations. Clinical laboratory tests
are regulated under CLIA, as administered by CMS, as well as by applicable state laws. In addition, the Federal Food, Drug and
Cosmetic Act, or FDCA, defines a medical device to include any instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article, including a component part, or accessory, intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
Our in vitro testing products are considered by the FDA to be subject to regulation as medical devices. Among other things,
pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety,
labeling, storage, recordkeeping, pre-market clearance or approval, marketing and promotion, and sales and distribution of
medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their
intended uses. In addition, the FDA regulates the export of medical devices manufactured in the United States to international
markets.
Although the FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, the FDA
has generally exercised its enforcement discretion and not enforced applicable regulations with respect to in vitro diagnostics
that are designed, manufactured, and used within a single laboratory for use only in that laboratory. These tests are referred to
as LDTs. As a result, we believe our diagnostic services are currently subject to the FDA’s enforcement discretion and are not
subject to the FDA’s oversight. However, reagents, instruments, software or components provided by third parties and used to
perform LDTs may be subject to regulation.
24
In recent years, FDA has stated its intention to modify its enforcement discretion policy with respect to LDTs. For example, on
July 31, 2014, the FDA notified Congress of its intent to modify, in a risk-based manner, its policy of enforcement discretion
with respect to LDTs. On October 3, 2014, the FDA issued two draft guidance documents entitled “Framework for Regulatory
Oversight of Laboratory Developed Tests (LDTs),” or the Framework Guidance, and “FDA Notification and Medical Device
Reporting for Laboratory Developed Tests (LDTs),” or the Reporting Guidance. The Framework Guidance states that FDA
intends to modify its policy of enforcement discretion with respect to LDTs in a risk-based manner consistent with the
classification of medical devices generally in Classes I through III. The Reporting Guidance would further enable FDA to
collect information regarding the LDTs currently being offered for clinical use through a notification process, as well as to
enforce its regulations for reporting safety issues and collecting information on any known or suspected adverse events related
to the use of an LDT.
Although the FDA halted finalization of the guidance in November 2016 to allow for further public discussion on an
appropriate oversight approach to LDTs and to give congressional authorizing committees the opportunity to develop a
legislative solution, the FDA could ultimately modify its current approach to LDTs in a way that would subject our products
marketed as LDTs to the enforcement of regulatory requirements.
Medical Device Regulatory Framework
Although we currently market our proprietary testing products as LDTs, which are currently subject to enforcement discretion,
we could be subject to more onerous FDA compliance obligations in the future. Specifically, if the FDA begins to actively
regulate LDTs, then, unless an exemption applies, each new or significantly modified medical device we seek to commercially
distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial
distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a premarket
approval, or PMA, application. Both the 510(k) clearance and PMA processes can be resource intensive, expensive, and
lengthy, and require payment of significant user fees.
Device Classification
Under the FDCA, medical devices are classified into one of three classes-Class I, Class II or Class III depending on the degree
of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to
safety and effectiveness.
Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably
assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices, which require
compliance with the applicable portions of the FDA’s Quality System Regulation, facility registration and product listing,
reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.
Some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described
below. Most Class I products are exempt from the premarket notification requirements.
Class II devices are those that are subject to the General Controls, and Special Controls as deemed necessary by the FDA to
ensure the safety and effectiveness of the device. These Special Controls can include performance standards, patient registries,
FDA guidance documents and post-market surveillance. Most Class II devices are subject to premarket review and clearance by
the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket
notification process.
Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices,
or implantable devices, in addition to those deemed novel and not substantially equivalent following the 510(k) process. The
safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and Special Controls
described above. Therefore, these devices are subject to the PMA application process, which is generally more costly and time-
consuming than the 510(k) process. Through the PMA application process, the applicant must submit data and information
demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction.
Accordingly, a PMA typically includes, but is not limited to, extensive technical information regarding device design and
development, pre-clinical and clinical trial data, manufacturing information, labeling and financial disclosure information for
the clinical investigators in device studies. The PMA application must provide valid scientific evidence that demonstrates to the
FDA’s satisfaction a reasonable assurance of the safety and effectiveness of the device for its intended use.
The Investigational Device Process
In the United States, absent certain limited exceptions, human clinical trials intended to support medical device clearance or
approval require an investigational device exemption, or IDE, application. Some types of studies deemed to present “non-
significant risk” are deemed to have an approved IDE once certain requirements are addressed and Institutional Review Board,
or IRB, approval is obtained. If the device presents a “significant risk” to human health, as defined by the FDA, the sponsor
must submit an IDE application to the FDA and obtain IDE approval prior to commencing the human clinical trials. The IDE
25
application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test
the device in humans and that the testing protocol is scientifically sound. Generally, clinical trials for a significant risk device
may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by
appropriate IRBs at the clinical trial sites. Submission of an IDE will note necessarily result in the ability to commence clinical
trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it
does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial
meets its intended success criteria.
All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling,
prohibit promotion and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study
investigators. Clinical trials must further comply with the FDA’s good clinical practice regulations for IRB approval and for
informed consent and other human subject protections. Required records and reports are subject to inspection by the FDA. The
results of clinical testing may be unfavorable, or, even if the intended safety and efficacy success criteria are achieved, may not
be considered sufficient for the FDA to grant marketing approval or clearance of a product. The commencement or completion
of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons.
The 510(k) Clearance Process
Under the 510(k) clearance process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the
device is “substantially equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that
is not subject to a PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which
a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was previously found
substantially equivalent through the 510(k) process. To be “substantially equivalent,” the proposed device must have the same
intended use as the predicate device, and either have the same technological characteristics as the predicate device or have
different technological characteristics and not raise different questions of safety or effectiveness than the predicate device.
Clinical data is sometimes required to support substantial equivalence.
After a 510(k) premarket notification is submitted, the FDA determines whether to accept it for substantive review. If it lacks
necessary information for substantive review, the FDA will refuse to accept the 510(k) notification. If it is accepted for filing,
the FDA begins a substantive review. By statute, the FDA is required to complete its review of a 510(k) notification within 90
days of receiving the 510(k) notification. As a practical matter, clearance often takes longer, and clearance is never assured.
Although many 510(k) premarket notifications are cleared without clinical data, the FDA may require further information,
including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review
process. If the FDA agrees that the device is substantially equivalent, it will grant clearance to commercially market the device.
If the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically
classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA
approval process, or seek reclassification of the device through the de novo process. The de novo classification process is an
alternate pathway to classify medical devices that are automatically classified into Class III, but which are low to moderate risk.
A manufacturer can submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate
device and the new device or new use of the device presents a moderate or low risk. De novo classification may also be
available after receipt of a “not substantially equivalent” letter following submission of a 510(k) to FDA.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that
would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the
modification, could require a PMA application. The FDA requires each manufacturer to determine whether the proposed
change requires a new submission in the first instance, but the FDA can review any such decision and disagree with a
manufacturer’s determination. Many minor modifications are accomplished by a letter-to-file in which the manufacture
documents the change in an internal letter-to-file. The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for
such change. The FDA can always review these letters to file in an inspection. If the FDA disagrees with a manufacturer’s
determination regarding whether a new premarket submission is required for the modification of an existing 510(k)-cleared
device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or
approval of a PMA application is obtained. In addition, in these circumstances, the FDA can impose significant regulatory fines
or penalties for failure to submit the requisite application(s).
The PMA Approval Process
Following receipt of a PMA application, the FDA conducts an administrative review to determine whether the application is
sufficiently complete to permit a substantive review. If it is not, the agency will refuse to file the PMA. If it is, the FDA will
accept the application for filing and begin the review. The FDA has 180 days to review a filed PMA application, although the
review of an application more often occurs over a significantly longer period of time. During this review period, the FDA may
26
request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter
to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.
Before approving or denying a PMA, an FDA advisory committee may review the PMA at a public meeting and provide the
FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific
conditions, or not approve it. The FDA is not bound by the recommendations of an advisory committee, but it considers such
recommendations carefully when making decisions.
Prior to approval of a PMA, the FDA may conduct inspections of the clinical trial data and clinical trial sites, as well as
inspections of the manufacturing facility and processes. Overall, the FDA review of a PMA application generally takes between
one and three years but may take significantly longer. The FDA can delay, limit or deny approval of a PMA application for
many reasons, including:
•
•
•
•
the device may not be shown safe or effective to the FDA’s satisfaction;
the data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval;
the manufacturing process or facilities may not meet applicable requirements; and
changes in FDA approval policies or adoption of new regulations may require additional data.
If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, the latter of
which usually contains a number of conditions that must be met in order to secure final approval of the PMA. When and if
those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing
commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter.
If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the
PMA or issue a not approvable letter. The FDA also may determine that additional tests or clinical trials are necessary, in which
case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an
amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are available. The PMA process can be
expensive, uncertain and lengthy and a number of devices for which the FDA approval has been sought by other companies
have never been approved by the FDA for marketing.
New PMA applications or PMA supplements are required for modification to the manufacturing process, equipment or facility,
quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, ingredients, materials or
design of a device that has been approved through the PMA process. PMA supplements often require submission of the same
type of information as an initial PMA application, except that the supplement is limited to information needed to support any
changes from the device covered by the approved PMA application and may or may not require as extensive technical or
clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
In approving a PMA application, as a condition of approval, the FDA may also require some form of post-approval study or
post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of
years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health
or to provide additional or longer term safety and effectiveness data for the device. The FDA may also approve a PMA
application with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among
other things, restrictions on labeling, promotion, sale, distribution and use. New PMA applications or PMA supplements may
also be required for modifications to any approved diagnostic tests, including modifications to our manufacturing processes,
device labeling and device design, based on the findings of post-approval studies.
Federal and State Physician Self-Referral Prohibitions
We are subject to the federal physician self-referral prohibitions, commonly known as the Stark Law, and to comparable state
laws. Together these restrictions generally prohibit us from billing a patient or any governmental or private payer for certain
designated health services, including clinical laboratory services, when the physician ordering the service, or any member of
such physician’s immediate family, has a financial interest, such as an ownership or investment interest in or compensation
arrangement with us, unless the arrangement meets an exception to the prohibition.
Sanctions for a Stark Law violation include the following:
•
•
•
•
denial of payment for the services provided in violation of the prohibition;
refunds of amounts collected by an entity in violation of the Stark Law;
a civil penalty for each bill or claim for a service arising out of the prohibited referral;
the imposition of up to three times the amounts for each item or service wrongfully claimed;
27
•
•
possible exclusion from federal healthcare programs, including Medicare and Medicaid; and
a civil penalty for each arrangement or scheme that the parties know (or should know) has the principal purpose of
circumventing the Stark Law’s prohibition.
These prohibitions apply regardless of any intent by the parties to induce or reward referrals or the reasons for the financial
relationship and the referral. In addition, knowing violations of the Stark Law may also serve as the basis for liability under the
federal False Claims Act, or the FCA, which can result in additional civil and criminal penalties.
Federal and State Anti-Kickback Laws
The federal Anti-Kickback Statute, or the AKS, makes it a felony for a person or entity, including a clinical laboratory, to
knowingly and willfully offer, pay, solicit or receive any remuneration, directly or indirectly, overtly or covertly, in cash or in
kind, in order to induce business that is reimbursable under any federal health care program. A violation of the AKS may result
in imprisonment for up to ten years and fines for each violation and administrative civil money penalties, including an
additional amount of up to three times the amount of the remuneration paid. Convictions under the AKS result in mandatory
exclusion from federal health care programs for a minimum of five years. In addition, The U.S. Department of Health and
Human Services, or HHS, has the authority to impose civil assessments and fines and to exclude health care providers and
others engaged in prohibited activities from Medicare, Medicaid and other federal health care programs. In addition, the
government may assert that a claim that includes items or services resulting from a violation of the AKS constitutes a false or
fraudulent claim under the FCA, which is discussed in greater detail below. Additionally, a person or entity does not need to
have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Although the AKS applies only to items and services reimbursable under any federal health care program, a number of states
have passed statutes substantially similar to the AKS that apply to all payors. Penalties of such state laws include imprisonment
and significant monetary fines.
Federal and state law enforcement authorities scrutinize arrangements between health care providers and potential referral
sources to ensure that the arrangements are not designed as a mechanism to induce patient care referrals or induce the purchase
or prescribing of particular products or services. Generally, courts have taken a broad interpretation of the scope of the AKS,
holding that the statute may be violated if merely one purpose of a payment arrangement is to induce referrals or purchases.
In addition to statutory exceptions to the AKS, regulations provide for a number of safe harbors. If an arrangement meets the
provisions of a safe harbor, it is deemed not to violate the AKS. An arrangement must fully comply with each element of an
applicable safe harbor in order to qualify for protection.
Failure to meet the requirements of the safe harbor, however, does not render an arrangement illegal. Rather, the government
may evaluate such arrangements on a case-by-case basis, taking into account all facts and circumstances.
Other Federal and State Health Care Laws
In addition to the requirements discussed above, several other health care fraud and abuse laws could have an effect on our
business. For example, provisions of the Social Security Act permit Medicare and Medicaid to exclude an entity that charges
the federal health care programs substantially in excess of its usual charges for its services. The terms “usual charge” and
“substantially in excess” are subject to varying interpretations.
The FCA prohibits, among other things, a person from knowingly presenting, or causing to be presented, a false or fraudulent
claim for payment or approval and from, making, using, or causing to be made or used, a false record or statement material to a
false or fraudulent claim in order to secure payment or retaining an overpayment by the federal government. 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. Because the complaint is initially filed under seal, the action may be
pending for some time before the defendant is even aware of the action. If the government intervenes and is ultimately
successful in obtaining redress in the matter or if the plaintiff succeeds in obtaining redress without the government’s
involvement, then the plaintiff will receive a percentage of the recovery. Finally, the Social Security Act includes its own
provisions that prohibit the filing of false claims or submitting false statements in order to obtain payment. Several states have
enacted comparable false claims laws which may be broader in scope and apply regardless of payor.
The civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to
have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an
item or service that was not provided as claimed or is false or fraudulent. A person who offers or provides to a Medicare or
Medicaid beneficiary any remuneration, including waivers of co-payments and deductible amounts (or any part thereof), that
the person 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 may be liable under the civil monetary penalties statute. Moreover,
in certain cases, providers who routinely waive copayments and deductibles for Medicare and Medicaid beneficiaries, for
28
example, in connection with patient assistance programs, can also be held liable under the AKS and FCA. One of the statutory
exceptions to the prohibition is non-routine, unadvertised waivers of copayments or deductible amounts based on individualized
determinations of financial need or exhaustion of reasonable collection efforts. The Office of Inspector General of HHS, or the
OIG, emphasizes, however, that this exception should only be used occasionally to address special financial needs of a
particular patient. Although this prohibition applies only to federal healthcare program beneficiaries, applicable state laws
related to, among other things, unlawful schemes to defraud, excessive fees for services, tortious interference with patient
contracts and statutory or common law fraud, may also be implicated for similar practices offered to patients covered by
commercial payor.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created new federal criminal statutes that
prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare
benefit program, including private third-party payors, and 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. Like the AKS, a person or entity does not need to have actual knowledge of the statute or
specific intent to violate it in order to have committed a violation.
The Physician Payments Sunshine Act, enacted as part of the ACA, as amended among other things, also imposed annual
reporting requirements on manufacturers of certain devices, drugs and biologics for certain payments and transfers of value by
them and in some cases their distributors to physicians and teaching hospitals, and certain other healthcare professionals
beginning January 1, 2022 for payments and transfers of value provided during the previous year; as well as ownership and
investment interests held by physicians and their immediate family members. Any failure to comply with these reporting
requirements could result in significant fines and penalties. Because we manufacture our own LDTs solely for use by or within
our own laboratory, we believe that we are exempt from these reporting requirements. We cannot assure you, however, that the
government will agree with our determination, and a determination that we have violated these laws and regulations, or a public
announcement that we are being investigated for possible violations, could adversely affect our business, prospects, results of
operations or financial condition.
State equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or
more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including
private insurers.
If our operations are found to be in violation of any of the fraud and abuse laws described above or any other laws that apply to
us, we may be subject to penalties, including potentially significant criminal, civil and administrative penalties, damages, fines,
disgorgement, imprisonment, exclusion from participation in government healthcare programs, contractual damages,
reputational harm, integrity oversight and reporting obligations, diminished profits and future earnings, and the curtailment or
restructuring of our operations.
International Regulations
Many countries in which we may offer any of our testing products in the future have anti-kickback regulations prohibiting
providers from offering, paying, soliciting or receiving remuneration, directly or indirectly, in order to induce business that is
reimbursable under any national health care program. In situations involving physicians employed by state-funded institutions
or national health care agencies, violation of the local anti-kickback law may also constitute a violation of the U.S. Foreign
Corrupt Practices Act, or FCPA.
The FCPA prohibits any U.S. individual, business entity or employee of a U.S. business entity to offer or provide, directly or
through a third party, including any potential distributors we may rely on in certain markets, anything of value to a foreign
government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage,
whether or not such conduct violates local laws. In addition, it is illegal for a company that reports to the SEC to have false or
inaccurate books or records or to fail to maintain a system of internal accounting controls. We will also be required to maintain
accurate information and control over sales and distributors’ activities that may fall within the purview of the FCPA, its books
and records provisions and its anti-bribery provisions.
The standard of intent and knowledge in the Anti-Bribery cases is minimal-intent and knowledge are usually inferred from that
fact that bribery took place. The accounting provisions do not require intent. Violations of the FCPA’s anti-bribery provisions
for corporations and other business entities are subject to a fine of up to $2 million and officers, directors, stockholders,
employees, and agents are subject to a fine of up to $100,000 and imprisonment for up to five years. Other countries, including
the United Kingdom and other OECD Anti-Bribery Convention members, have similar anti-corruption regulations, such as the
United Kingdom Anti-Bribery Act.
When marketing our testing products outside of the United States, we may be subject to foreign regulatory requirements
governing human clinical testing, prohibitions on the import of tissue necessary for us to perform our testing products or
restrictions on the export of tissue imposed by countries outside of the United States or the import of tissue into the United
29
States, and marketing approval. These requirements vary by jurisdiction, differ from those in the United States and may in some
cases require us to perform additional pre-clinical or clinical testing. In many countries outside of the United States, coverage,
pricing and reimbursement approvals are also required.
Privacy and Security Laws
Health Insurance Portability and Accountability Act
Under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, HHS
has issued regulations to protect the privacy and provide for the security of protected health information, or PHI, used or
disclosed by certain entities including health care providers, such as us. HIPAA also regulates standardization of data content,
codes and formats used in certain health care transactions and standardization of identifiers for health plans and providers.
Penalties for violations of HIPAA and HITECH laws and regulations include significant civil and criminal penalties.
Three standards have been promulgated under HIPAA’s and HITECH’s regulations: the Standards for Privacy of Individually
Identifiable Health Information, which restrict the use and disclosure of certain individually identifiable health information, the
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, and the Security Standards for the
Protection of Electronic Protected Health Information, which require covered entities and business associates to implement and
maintain certain security measures to safeguard certain electronic health information, including the adoption of administrative,
physical and technical safeguards to protect such information.
The HIPAA privacy regulations cover the use and disclosure of PHI by covered entities and business associates, which are
defined to include subcontractors that create, receive, maintain, or transmit PHI on behalf of a covered entity, as well as their
covered subcontractors. They also set forth certain rights that an individual has with respect to his or her PHI maintained by a
covered entity, including the right to access or amend certain records containing PHI, or to request restrictions on the use or
disclosure of PHI. The HIPAA security regulations establish requirements for safeguarding the confidentiality, integrity, and
availability of PHI that is electronically transmitted or electronically stored. HITECH, among other things, established certain
health information security breach notification requirements. A covered entity must notify any individual whose PHI is
breached according to the specifications set forth in the breach notification rule. The HIPAA privacy and security regulations
establish a uniform federal “floor” and do not preempt state laws that are more stringent or provide individuals with greater
rights with respect to the privacy or security of, and access to, their records containing PHI or insofar as such state laws apply to
personal information that is broader in scope than PHI.
Individuals (or their personal representatives, as applicable) have the right to access test reports directly from laboratories and to
direct that copies of those reports be transmitted to persons or entities designated by the individual.
HIPAA authorizes state attorneys general to file suit on behalf of their residents for violations. Courts are able to award
damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of
action allowing individuals to file suit against us in civil court for violations of HIPAA, its standards have been used as the
basis for duty of care cases in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI. In
addition, HIPAA mandates that the Secretary of HHS conduct periodic compliance audits of HIPAA covered entities, such as
us, and their business associates for compliance with the HIPAA privacy and security standards. It also tasks HHS with
establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a
percentage of the civil monetary penalty paid by the violator.
As a covered entity with downstream vendors and subcontractors and, in certain instances, as a business associate of other
covered entities with whom we have entered into a business associate agreement, we have certain obligations under HIPAA
regarding the use and disclosure of any PHI that may be provided to us. HIPAA and HITECH impose civil and criminal
penalties against covered entities and business associates for noncompliance with privacy and security requirements. Further,
various states, such as California and Massachusetts, have implemented similar privacy laws and regulations that impose
restrictive requirements regulating the use and disclosure of health information and other personally identifiable information, or
PII.
Numerous other federal, state and foreign laws, including consumer protection laws and regulations, govern the collection,
dissemination, use, access to, confidentiality and security of patient health information. We intend to continue to
comprehensively protect all personal information and to comply with all applicable laws regarding the protection of such
information.
Reimbursement for Clinical Laboratory Services
We generate revenue on our products from several sources, including third-party payors, laboratory services intermediaries, and
self-paying individuals. Depending on the billing arrangement and applicable law, we must bill various third-party payors, such
as insurance companies, Medicare, Medicaid, and patients, all of which have different billing requirements. Compliance with
30
applicable laws and regulations as well as internal compliance policies and procedures adds further complexity to the billing
process. CMS establishes new procedures and continuously evaluates and implements changes to the reimbursement process for
billing the Medicare program.
To receive reimbursement from third-party payors, we bill our tests using a variety of CPT codes, as defined by the AMA. For
those genetic tests we conduct that do not have a dedicated CPT code, test may be billed under a miscellaneous code for an
unlisted molecular pathology procedure. Because these miscellaneous codes do not describe a specific service, the third-party
payor claim may need to be examined to determine the service that was provided, whether the service was appropriate and
medically necessary and whether payment should be rendered. This process can require a letter of medical necessity from the
ordering physician and it can result in a delay in processing the claim, a lower reimbursement amount, or denial of the claim.
With the evolution of genetic testing, we have seen individual third-party payors’ medical coverage policies around the CPT
codes we bill and their associated payment rates change over time, resulting in changes to our reimbursement revenues. We
believe all of our products provide significant clinical value and reduction in downstream healthcare spend, as evidenced in
research studies and clinical publications, which we believe will continue to support and drive third-party payor reimbursement.
Under Medicare, payment for products like ours is generally made under the Clinical Laboratory Fee Schedule, or CLFS, with
payment amounts assigned to specific procedure billing codes. In April 2014, Congress passed the Protecting Access to
Medicare Act, or PAMA, which included substantial changes to the way in which clinical laboratory services will be paid under
Medicare. Under PAMA, certain laboratories were required to report to CMS private payor payment rates and volumes for their
tests. CMS uses this data to calculate a weighted median payment rate for each test, which will be used to establish revised
Medicare CLFS reimbursement rates for the test. Laboratories that fail to report the required payment information may be
subject to substantial civil penalties. We bill Medicare for our products, and therefore we are subject to reporting requirements
under PAMA.
On May 17, 2019, CMS determined that DecisionDx-UM meets the criteria for “existing ADLT” status. Accordingly, in 2021
the DecisionDx-UM Medicare rate will be set annually based upon the median private payor rate for the first half of the second
preceding calendar year. Note that our rate for 2020 was set by Noridian, our local MAC, but our rate for 2021 for DecisionDx-
UM will be $7,776 based on the median private payor rate. Also, on May 17, 2019, CMS determined that DecisionDx-
Melanoma meets the criteria for “new ADLT” status. Accordingly, from July 1, 2019 through March 31, 2020, the Medicare
reimbursement rate was equal to the initial list price of $7,193. From April 1, 2020 through December 31, 2021, CMS notified
us that the rate will also be $7,193, which was calculated based upon the median private payor rate for DecisionDx-Melanoma
from July 1, 2019 to November 30, 2019. Beginning in 2022, the rate for both DecisionDx-Melanoma and DecisionDx-UM will
be set annually based upon the median private payor rate for the first half of the second preceding calendar year. For example,
the rate for 2022 will be set using median private payor rate data from January 1, 2020 to June 30, 2020.
In the second quarter of 2020, we submitted our technical assessment dossier for DecisionDx-SCC to Palmetto and Noridian. In
early 2021, we submitted our technical assessment dossier for DecisionDx DiffDx-Melanoma. We expect that draft LCDs for
each of these tests will be posted in 2021. However, there is no assurance that the timing of any draft LCD or final LCD will
match our expectations or our historical experience with LCDs for our other tests.
PAMA also authorizes the adoption of new, temporary billing codes and/or unique test identifiers for FDA-cleared or approved
tests as well as ADLTs. The AMA’s CPT Editorial Panel has approved a proposal to create a new section of billing codes to
facilitate implementation of this section of PAMA. These proprietary laboratory analyses codes may be requested by a clinical
laboratory or manufacturer to specifically identify their test. If approved, the codes are issued by the AMA on a quarterly basis.
Our DecisionDx-UM test was granted a Category I MAAA CPT code and was effective January 1, 2020. Our DecisionDx-
Melanoma test was granted a Category I MAAA CPT code and was effective January 1, 2021.
Healthcare Reform
In March 2010, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education
Reconciliation Act of 2010, collectively the ACA, became law. The ACA contains a number of provisions that are expected to
impact our business and operations, some of which in ways we cannot currently predict, including those governing enrollment
in state and federal healthcare programs, reimbursement changes and fraud and abuse, which impact existing state and federal
health care programs and will result in the development of new programs Among other things, the ACA required each medical
device manufacturer to pay a sales tax equal to 2.3% of the price for which such manufacturer sells its medical devices, and
began to apply to sales of taxable medical devices after December 31, 2012, but was suspended in 2016. Further, the 2020
federal spending package permanently eliminated, effective January 1, 2020, the medical device tax and “Cadillac” tax on high-
cost employer-sponsored health coverage and, effective January 1, 2021, also eliminates the health insurer tax. The ACA also
contains a number of other provisions, including provisions governing enrollment in federal and state healthcare programs,
reimbursement matters and fraud and abuse, which we expect will impact our industry and our operations in ways that we
cannot currently predict.
31
Since 2016, there have been efforts to repeal all or part of the ACA, and the previous administration and the U.S. Congress have
taken action to roll back certain provisions of the ACA. It is unknown what actions, if any, the current administration and the
U.S. Congress may take regarding the ACA.
Additionally, on December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety
because the tax penalty on certain individuals who fail to maintain qualifying health coverage for all or part of a year,
commonly referred to as the “individual mandate.” Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th
Circuit ruled that the individual mandate was unconstitutional and remanded the case back to the District Court to determine
whether the remaining provisions of the ACA are invalid as well. The United States Supreme Court is currently reviewing this
case, but it is unclear when a decision will be made. It is also unclear how the Supreme Court ruling, other such litigation and
the healthcare reform measures of the Biden administration will impact the ACA.
Human Capital Resources
Overview
As of December 31, 2020, we had 201 employees, of whom 199 were full-time employees. During the year ended December
31, 2020, our employee count grew by 66 persons, or 48.9%. We face competition for experienced, qualified personnel in our
industry, particularly for highly skilled scientists, laboratory technicians and salespeople.
The tables below provide information on the distribution of our employees by functional area and by location as of December
31, 2020:
Laboratory Testing Operations
Research & Development
Sales & Marketing
Administrative & General
Total as of December 31, 2020
Friendswood, Texas
Phoenix, Arizona
Home-based throughout the U.S.
Total as of December 31, 2020
Number of
Employees
37
40
74
50
201
Number of
Employees
52
61
88
201
Our employees are not represented by labor unions or covered by collective bargaining agreements. We consider our
relationship with our employees to be good.
Diversity and Inclusion
We recognize the importance of diversity and inclusion in recruiting, developing and retaining the best available talent. We are
committed to further understanding and building upon our existing diversity and inclusion strengths and are in the process of
identifying opportunities and developing related initiatives.
As of December 31, 2020, our employees were 62.7% female and 37.3% male. Our overall employee population as of
December 31, 2020 was 79.1% White, 9.5% Hispanic or Latino, 5.0% Asian, 1.5% Black or African-American and 4.9% two
or more races (not Hispanic or Latino) and other. In executive positions, which we define as Executive Director or Regional
Business Director level and above, our employee population as of December 31, 2020 was 86.4% White, 4.6% American
Indian or Alaska Native, 4.6% Hispanic or Latino and 4.4% two or more races (not Hispanic or Latino). Females represented
31.8% of employees in executive positions. We are continuing to further assess and understand additional measures of
diversity.
32
Compensation, Benefits and Professional Development
We are committed to offering competitive benefits and compensation packages to our employees. In addition to competitive
base pay, we offer the following benefits, among others, to our full-time employees:
•
•
•
a defined contribution 401(k) plan with employer matching contributions;
an annual bonus opportunity;
equity compensation, including stock options, restricted stock units and an employee stock purchase plan;
• medical, dental and vision plans;
•
•
•
paid maternity, paternity and adoption leave policies;
paid holidays and paid time off; and
an employee assistance program.
We survey all new hires 90 days after the start of their employment to solicit feedback on employee engagement. We provide
performance reviews at least once per year, with pay raises commensurate with market and performance indicators.
We prioritize and encourage internal growth and professional development of our employees. To encourage employee
development, we offer a professional development reimbursement program to eligible employees who attend job-related
professional development activities.
Corporate and Other Information
We were incorporated in Delaware in September 2007. Our principal executive offices are located at 820 S. Friendswood
Drive, Suite 201, Friendswood, Texas 77456 and our telephone number is (866) 788-9007. Our corporate website address is
www.CastleBiosciences.com. Information contained on or accessible through our website is not considered part of this Annual
Report on Form 10-K or our other filings with the SEC. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and any amendments to such reports filed or furnished pursuant to Section 13(a) and 15(d) of the
Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge on our website as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
This Annual Report on Form 10-K contains references to our trademarks and to trademarks belonging to other entities. Solely
for convenience, trademarks and trade names referred to in this Annual Report on Form 10-K, including logos, artwork and
other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way,
that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our
use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us
by, any other companies.
33
Item 1A. Risk Factors.
You should consider carefully the risks described below, as well as the other information in this Annual Report on Form 10‑K,
before deciding whether to purchase, hold or sell shares of our common stock. The occurrence of any of the following risks
could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ
materially from those contained in forward-looking statements we have made in this report and those we may make from time
to time. You should consider all of the factors described as well as the other information in this Annual Report on Form 10-K,
including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” when evaluating our business. If any of the following risks actually occur, our business, financial
condition, results of operations and future growth prospects could be materially and adversely affected. In these circumstances,
the market price of our common stock could decline and you may lose all or part of your investment. Additional risks and
uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
Risks Related to Our Financial Condition
Our reliance upon a small number of third-party payors for a significant portion of our revenue may materially adversely
affect our financial condition and results of operations.
We receive a substantial portion of our revenue from a small number of third-party payors, primarily Medicare. Our revenue for
our test reports provided for patients covered by Medicare as a percentage of total revenue, was 58% for the year ended
December 31, 2020 and 49% for the year ended December 31, 2019. If our largest current payors were to significantly reduce,
or cease to pay, the amount they reimburse for our products, or if they do not reach favorable coverage and reimbursement
decisions for our products, or attempt to recover amounts they had already paid, it could have a material adverse effect on our
business, financial condition and results of operations and cause significant fluctuations in our results of operations.
Due to how we recognize revenue, our quarterly revenues may not reflect our underlying business.
We have concluded that our contracts include variable consideration because the amounts paid by Medicare or commercial
health insurance carriers may be paid at less than our standard rates or not paid at all, with such differences considered implicit
price concessions. Variable consideration attributable to these price concessions is measured at the expected value using the
‘‘most likely amount’’ method under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers,
or ASC 606. The amounts are determined by historical average collection rates by test type and payor category taking into
consideration the range of possible outcomes, the predictive value of our past experiences, the time period of when uncertainties
expect to be resolved and the amount of consideration that is susceptible to factors outside of our influence, such as the
judgment and actions of third parties. Such variable consideration is included in the transaction price only to the extent it is
probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with
respect to the amount are resolved. Variable consideration may be constrained and excluded from the transaction price in
situations where there is no contractually agreed upon reimbursement coverage or in the absence of a predictable pattern and
history of collectability with a payor. Variable consideration for Medicare claims that are not covered by an LCD, including
those claims subject to approval by an Administrative Law Judge, or ALJ, at an appeal hearing, is deemed to be fully
constrained due to factors outside our influence (i.e., judgment or actions of third parties) and the uncertainty of the amount to
be received is not expected to be resolved for a long period of time. Variable consideration is evaluated each reporting period
and adjustments are recorded as increases or decreases in revenues. As a result of the timing and amount of adjustments for
variable consideration, our operating results and comparisons of such results on a period-to-period basis may be difficult to
understand and may not be meaningful. In addition, these fluctuations in revenue may make it difficult for us, for research
analysts and for investors to accurately forecast our revenue and operating results. If our revenue or operating results fall below
expectations, the price of our common stock would likely decline.
We have incurred significant losses since inception, and we may never achieve profitability.
Since our inception, we have had a history of net losses. For the year ended December 31, 2020, we had a net loss of
$10.3 million and an accumulated deficit of approximately $62.5 million. We cannot predict if we will achieve profitability in
the near future or at all. We expect to incur losses in the future as we plan to invest significant additional funds toward the
expansion of our commercial organization, the conduct of clinical utility and validity studies to support adoption of our
products and the development or acquisition of additional products. We also expect significant increases in our stock-based
compensation expense in future periods, reflecting higher stock option valuations as a public company and additional awards
outstanding due to increased headcount. Additionally, our performance could be affected by the ongoing impacts of COVID-19.
As a public company, we expect to continue to incur significant additional legal, accounting and other expenses that we did not
incur as a private company. These increased expenses will make it harder for us to achieve future profitability. We may also
incur significant losses in the future for a number of reasons, many of which are beyond our control, including the other risks
described in this Annual Report on Form 10‑K, adoption of our products, coverage of and reimbursement rates for our products
34
from third-party payors, and future research and development activities. Our failure to achieve profitability in the future could
cause the market price of our common stock to decline and make it more difficult or costly for us to raise additional capital.
We are an early, commercial-stage company and have a limited operating history, which may make it difficult to evaluate
our current business and predict our future performance.
We are an early commercial-stage company and have a limited operating history. Our limited operating history may make it
difficult to evaluate our current business and this makes predictions about our future success or viability subject to significant
uncertainty. In particular, we intend to use a portion of our working capital to increase our headcount, including through the
expansion of our sales and marketing and research and development teams, which will increase our operating costs in a manner
not historically reflected in our financial statements. In combination with our other anticipated increased operating expenses in
connection with the ongoing demands of a public company, these anticipated changes in our operating expenses may make it
difficult to evaluate our current business, assess our future performance relative to prior performance and accurately predict our
future performance.
We will continue to encounter risks and difficulties frequently experienced by early commercial-stage companies, including
those associated with increasing the size of our organization and the prioritization of our commercial, research and business
development activities. If we do not address these risks successfully, our business could suffer.
Changes in financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and
affect our reported operating results.
Accounting principles generally accepted in the United States of America are subject to interpretation by the Financial
Accounting Standards Board, the SEC, and various bodies formed to promulgate and interpret appropriate accounting
principles. A change in accounting standards or practices can have a significant effect on our reported results and may even
affect our reporting of transactions completed before the change is effective. New accounting pronouncements and varying
interpretations of accounting pronouncements have occurred and may occur in the future. For example, in response to the
COVID-19 crisis, accounting standard setters may issue additional guidance or interpretations of existing guidance to address
the financial reporting and accounting issues that have arisen or that may arise from the pandemic. Changes to existing rules or
the questioning of current practices may adversely affect our reported financial results or the way we conduct our business.
Our quarterly and annual operating results and cash flows may fluctuate in the future, which could cause the market price
of our stock to decline substantially.
Numerous factors, many of which are outside our control, such as the COVID-19 pandemic, may cause or contribute to
significant fluctuations in our quarterly and annual operating results. These fluctuations may make financial planning and
forecasting uncertain. In addition, these fluctuations may result in unanticipated decreases in our available cash, which could
negatively affect our business and prospects. In addition, one or more of such factors may cause our revenue or operating
expenses in one period to be disproportionately higher or lower relative to the others. As a result, comparing our operating
results on a period-to-period basis may be difficult to understand and may not be meaningful. You should not rely on our past
results as indicative of our future performance.
In addition, a significant portion of our operating expense is relatively fixed in nature, and planned expenditures are based in
part on expectations regarding future revenue. Accordingly, unexpected revenue shortfalls could decrease our gross margins
and cause significant changes in our operating results from quarter to quarter. If this occurs, the trading price of our stock could
fall substantially.
This variability and unpredictability caused by factors such as those described above could also result in our failing to meet the
expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the
expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the
expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline
could occur even when we have met any previously publicly stated guidance we may provide.
We previously identified material weaknesses in our internal control over financial reporting. If our internal control over
financial reporting is not effective, we may not be able to accurately report our financial results or file our periodic reports
in a timely manner, which may cause adverse effects on our business and may cause investors to lose confidence in our
reported financial information and may lead to a decline in our stock price.
Effective internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner. A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there
is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or
detected on a timely basis. In connection with the audits of our financial statements for the years ended December 31, 2018 and
2017, we concluded that there were material weaknesses in our internal control over financial reporting. However, in
35
connection with audit of our financial statements for the year ended December 31, 2019, we concluded these material
weaknesses had been remediated.
These prior material weaknesses related to a lack of (i) appropriately designed and implemented controls over the review and
approval of manual journal entries and the related supporting journal entry calculations, (ii) personnel with appropriate
knowledge, experience and training commensurate with accounting and reporting requirements and (iii) appropriately designed
and implemented controls to evaluate variable consideration and the related constraint in accordance with ASC 606, and
resulted in certain material corrections to the financial statements.
To remediate these weaknesses, during 2019 we hired a full-time director of SEC reporting and technical accounting and
another full-time accounting resource, both certified public accountants with active licenses, to augment our accounting staff
and to provide more resources for complex accounting matters and financial reporting. We also commenced development of a
new information technology tool designed to improve the efficiency of our processes with respect to revenue recognition under
ASC 606 and hired personnel to support our revenue accounting and related activities under ASC 606. Further, we engaged a
third party to assist us with formalizing our internal control documentation and implementation of enhancements to our internal
control over financial reporting.
During 2020, we added additional full-time accounting personnel, including an additional certified public accountant with an
active license, to further support the demands placed upon us as a public company, including the requirements of the Sarbanes-
Oxley Act of 2002, or Sarbanes-Oxley. We expect to continue expending significant time and resources related to our internal
control over financial reporting, including by further expanding our finance and accounting staff, but there can be no assurance
our efforts will be effective.
If we fail to adequately staff our accounting and finance function, or fail to maintain adequate internal control over financial
reporting, any new or recurring material weaknesses could prevent our management from concluding our internal control over
financial reporting is effective. If we identify any future significant deficiencies or material weaknesses, the accuracy and
timing of our financial reporting may be adversely affected, our ability to prevent material misstatements in our financial
statements could be impaired, a material misstatement in our financial statements could occur and we may be unable to
maintain compliance with securities law requirements regarding timely filing of periodic reports, which could cause our
business to suffer and our stock price to decline.
We may need to raise additional capital to fund our existing operations, commercialize new products or expand our
operations.
We believe our existing cash and cash equivalents and anticipated cash generated from sales of our products will be sufficient
to fund our operations for the foreseeable future. If our available cash and cash equivalents and anticipated cash generated from
sales of our products are insufficient to satisfy our liquidity requirements including because of lower demand for our products,
lower than currently expected rates of reimbursement from third-party payors or other risks described in this Annual Report on
Form 10-K, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic
alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of
funds. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we
believe we have sufficient funds for our current or future operating plans.
We may consider raising additional capital in the future to expand our business, to pursue strategic investments, to take
advantage of financing opportunities or for other reasons, including to:
•
•
•
•
•
•
•
increase our sales and marketing efforts for DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx DiffDx-Melanoma
and DecisionDx-UM and address competitive developments;
fund ongoing evidence development for our existing products as well as additional pipeline programs;
expand our laboratory testing facility and related testing capacity;
expand our technologies into other types of skin cancer management and detection products;
acquire, license or invest in technologies;
acquire or invest in complementary businesses or assets; and
finance capital expenditures and general and administrative expenses.
Our present and future funding requirements will depend on many factors, including:
•
our ability to achieve revenue growth;
36
•
•
•
•
•
•
•
our rate of progress in establishing payor coverage and reimbursement arrangements with third-party payors;
our rate of progress in, and cost of the sales, marketing, coverage and reimbursement activities associated with,
establishing adoption of DecisionDx-Melanoma, among our other products;
the cost of expanding our laboratory operations and offerings, including our sales, marketing, coverage and
reimbursement efforts;
our rate of progress in, and cost of research and development activities associated with, diagnostic products in research
and early development;
the potential cost of, and delays in, the development of new products as a result of changes in regulatory oversight
applicable to our products;
the effects of the COVID-19 pandemic; and
the effect of competing technological and market developments.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest
will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as
a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or
capital expenditures or declaring dividends.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with
third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or
products, or grant licenses on terms that may not be favorable to us.
In addition, the COVID-19 crisis continues to rapidly evolve and has already resulted in a significant disruption of global
financial markets. Our ability to raise additional capital may be adversely impacted by potential worsening global economic
conditions and the recent disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide resulting
from the crisis. If the disruption persists and deepens, we could experience an inability to access additional capital. If we are
unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to
delay, limit, reduce or terminate our commercialization, research and development efforts or grant rights to third parties to
market and/or develop products that we would otherwise prefer to market and develop ourselves.
Risks Related to Our Business
The COVID-19 pandemic has adversely impacted and could continue to adversely impact our business, including the
demand for our test reports, as well as the business or operations of physicians and other healthcare providers who order
our test reports and the third-party payors responsible for reimbursement for our tests, customers and other third parties
with whom we conduct business.
Public health crises such as pandemics or similar outbreaks have adversely impacted and could continue to adversely impact
our business. In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, surfaced in Wuhan,
China. Since then, COVID-19 has spread to multiple countries, including the United States. On March 11, 2020, the World
Health Organization declared COVID-19 a pandemic. As a result of the COVID-19 outbreak, or similar pandemics, and federal,
state and local government responses to pandemics, we have and/or may in the future experience disruptions that could
adversely impact our business, including, but not limited to:
•
•
•
•
decreased test report volume due to a decline in orders of DecisionDx-Melanoma and DecisionDx-UM tests as patient
visits for routine examinations and biopsies are being delayed and/or canceled;
disruption of our sales and commercialization activities due to limitations on our ability to communicate with
physicians as a result of travel restrictions and hindered means of communicating with physicians;
delays or disruptions by third parties in the collection, preparation or delivery of the tumor samples that we test;
delays or difficulties in delivering test reports, interruptions in research and development and other limitations of key
business activities due to members of our workforce becoming ill and/or stay-at-home or other similar orders imposed
by or that may be imposed by state and local governments, including at our Phoenix, Arizona and Friendswood, Texas
locations;
37
•
•
delayed reimbursement from third party payors, disruption in our supply channel and other adverse impacts on our
business resulting from the negative effects of the COVID-19 pandemic on our suppliers, service providers and other
third parties on whom we rely; and
delayed or postponed interactions with regulators and other important agencies and contractors, due to limitations in
employee resources, travel restrictions or forced furlough of government employees.
Following the onset of the COVID-19 pandemic, we began experiencing declines in orders and test report volume. For
example, in the second quarter of 2020, test reports delivered for our lead product, DecisionDx-Melanoma, decreased 18.5%
compared to the second quarter of 2019. For the year ended December 31, 2020, our growth in DecisionDx-Melanoma test
report volume was 4.5%, compared to year-over-year growth of 29.1% for the year ended December 31, 2019. We believe the
adverse impacts to our test report volume growth are linked to delays and/or cancellations in patient visits, resulting in reduced
diagnostic biopsies and thus reduced diagnoses of cutaneous melanoma in response to COVID-19.
Our future results will be dependent upon the extent and duration of the COVID-19 crisis as well as the impact of ongoing state
and local government restrictions, which are beyond our control, and which may be eased and/or reinstated from time to time
depending on the circumstances, potentially impacting the flow of future patient visits and diagnosis of cutaneous melanoma.
Even with the easing of state and local restrictions, patient visits may be impacted by continued apprehension regarding
possible exposure to the virus. As conditions are continuously evolving, we are unable to predict how our future test report
volume will be impacted or the extent to which our results of operations, financial condition or cash flows will be impacted by
the COVID-19 pandemic, or other future public health crises. Accordingly, the test report data presented above and elsewhere
in this Annual Report on Form 10-K is not necessarily indicative of our results of operations that can be expected in future
periods.
Under legislation enacted (or that may be enacted) by the United States federal government to respond to COVID-19, we have
received and may receive in the future, cash payments or other forms of assistance allocated to healthcare and other companies.
The eligibility requirements for any such payments or other assistance may be subject to restrictive terms and conditions, which
may be ambiguous or subject to further modification, interpretation and guidance issued by government agencies on an ongoing
basis. In the event we fail to comply with any of the terms or conditions associated with a payment we receive or if the terms
and conditions or related interpretations change, we may be required to return it. The receipt of government payments or other
assistance during the COVID-19 crisis has generated negative publicity for some companies and may continue to generate
negative publicity for companies in the future. If we receive any negative publicity as a result of receiving or accepting a
government payment or other assistance, it could harm our reputation, trigger a review or audit by applicable government
agencies and/or adversely impact our stock price.
The COVID-19 crisis continues to rapidly evolve. The extent to which COVID-19 will impact our business will depend on
future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the crisis,
resurgences of the virus, the availability and effectiveness of vaccinations or therapeutic treatments, the use of telemedicine,
travel restrictions, stay-at-home or other similar orders and social distancing in the United States and other countries, business
closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and
treat the virus. Any of these factors, individually or in combination, could materially and adversely affect our business, results
of operations, financial condition or cash flows. In addition, the current and potential adverse impacts of the COVID-19 crisis
on our business, financial condition, results of operations and growth prospects, may also have the effect of heightening many
of the other risks and uncertainties described elsewhere in this “Risk Factors” section.
Our revenue currently depends primarily on sales of DecisionDx-Melanoma, and we will need to generate sufficient revenue
from this and other products to grow our business.
Most of our revenue in 2020 and 2019 was derived from the sale of our lead product, DecisionDx-Melanoma. While we also
derive revenue from DecisionDx-UM and expect to derive revenue from DecisionDx-SCC and DecisionDx DiffDx-Melanoma,
we expect that the majority of our revenue for the foreseeable future will be derived from sales of DecisionDx-Melanoma.
Further, we believe that our long-term commercial success will depend on our ability to develop and market additional
products. Our ability to derive revenue from DecisionDx-Melanoma, DecisionDx-UM, DecisionDx-SCC, DecisionDx DiffDx-
Melanoma and any future products that we commercialize is uncertain and depends on favorable coverage and reimbursement
policies from government payors, like Medicare, and from private payors, like insurance companies. Without positive coverage
policies, our products may not be reimbursed and we may not be able to recognize revenue. If we are unable to increase sales
and expand coverage and reimbursement for DecisionDx-Melanoma, develop and commercialize other products, and
successfully obtain coverage and adequate reimbursement for such products, our revenue and our ability to achieve
profitability would be impaired, and the market price of our stock could decline substantially.
38
Billing for our products is complex and requires substantial time and resources to collect payment.
Billing for clinical laboratory testing services is complex, time-consuming and expensive. Depending on the billing
arrangement and applicable law, we bill various payors, including Medicare, Medicaid, private insurance companies, private
healthcare institutions, and patients, all of which have different billing requirements. We generally bill third-party payors for
products and pursue reimbursement on a case-by-case basis where pricing contracts are not in place. To the extent laws or
contracts require us to bill patient co-payments or co-insurance, we must also comply with these requirements. We may also
face increased risk in our collection efforts, including potential write-offs of accounts receivable and long collection cycles,
which could adversely affect our business, results of operations and financial condition.
Several factors make the billing process complex, including:
•
•
•
•
•
•
•
•
•
•
•
differences between the billing rates and reimbursement rates for our products;
compliance with complex federal and state regulations related to billing government healthcare programs, including
Medicare, Medicaid and TRICARE;
risk of government audits related to billing;
disputes among payors as to which party is responsible for payment;
differences in coverage and information and billing requirements among payors, including the need for prior
authorization and/or advanced notification;
the effect of patient co-payments or co-insurance and our ability to collect such payments from patients;
changes to billing codes used for our products;
changes to requirements related to our current or future clinical studies, including our registry studies, which can affect
eligibility for payment;
ongoing monitoring provisions of LCDs for our products, which can affect the circumstances under which a claim
would be considered medically necessary;
incorrect or missing billing information; and
the resources required to manage the billing and claims appeals process.
We use standard industry billing codes, known as CPT codes, to bill for our products. If these codes were to change, there is a
risk of an error being made in the claim adjudication process. Such errors can occur with claims submission, third-party
transmission or in the processing of the claim by the payor. Claim adjudication errors may result in a delay in payment
processing or a reduction in the amount of the payment we receive.
As we introduce new products, we may need to add new codes to our billing process as well as our financial reporting systems.
Failure or delays in effecting these changes in external billing and internal systems and processes could negatively affect our
collection rates, revenue and cost of collecting.
Additionally, our billing activities require us to implement compliance procedures and oversight, train and monitor our
employees, and undertake internal audits to evaluate compliance with applicable laws and regulations as well as internal
compliance policies and procedures. When payors deny our claims, we may challenge the reason, low payment amount or
payment denials. Payors also conduct external audits to evaluate payments, which add further complexity to the billing process.
If the payor makes an overpayment determination, there is a risk that we may be required to return all or some portion of prior
payments we have received.
Additionally, the ACA requires providers and suppliers to report and return any overpayments received from government
payors under the Medicare and Medicaid programs within 60 days of identification. Failure to identify and return such
overpayments exposes the provider or supplier to liability under federal false claims laws. These billing complexities, and the
related uncertainty in obtaining payment for our products, could negatively affect our revenue and cash flow, our ability to
achieve profitability, and the consistency and comparability of our results of operations.
In addition to the complexities noted above, we rely upon third-party service providers and third-party software applications in
the administration of our billing and collecting process. We are transitioning from a third-party billing service provider and
have added additional headcount to move our billing process in-house using a third-party software application starting January
1, 2021. Any significant disruption or deficiency in the design or implementation of the new billing process could adversely
impact our ability to generate and send invoices, calculate revenues, track payments and collect our accounts receivable.
39
Additionally, any failure in the design or operation of our internal controls related to our billing and collection processes could
adversely impact our ability to conclude on the effectiveness of our internal control over financial reporting.
We rely on third parties for tumor sample collection, preparation and delivery. Any defects in sample collection or
preparation by such third parties and any delays in delivery of such samples could cause errors in our test reports and delay
our ability to deliver test reports in a timely manner, which could significantly harm our business.
The tumor tissue samples that we test are biopsied, preserved, prepared and delivered to us by third parties, including
dermatopathologists and laboratory facilities. As such, we rely on these third parties to prepare, label and deliver the tissue
samples that we test in compliance with applicable laws and guidelines, and in a timely manner. Therefore, the accuracy and
correctness of the test reports that we deliver are dependent on proper chain of custody and appropriate methods of sample
collection or preparation utilized by these third parties, and our ability to timely deliver reports is dependent upon the ability of
these third parties to provide these samples to us in a timely manner. The ability of these third parties to provide these samples
to us in a timely manner could be delayed by events beyond our control, including but not limited to natural disasters and public
health epidemics, such as the COVID-19 crisis. Any errors in any part of the sample collection or preparation process could
cause us to deliver incorrect test reports, potentially resulting in harm to patients whose physicians implement a change in
treatment decisions based upon our test report. If we are unable to timely deliver test reports, physicians may be less likely to
recommend and order our products. The occurrence of any of the foregoing could significantly harm our reputation and our
results of operations, causing significant harm to our business.
We rely on our database of tumor samples for the development and improvement of our products. Depletion or loss of our
tumor samples could significantly harm our business.
The development and validation of accurate products is a complex process that requires access to tumor tissue specimens and
long-term outcomes data. Our research and development efforts to improve our existing products and develop new products
may require the depletion of our existing database of tumor samples. If our tumor samples are lost or destroyed, or substantially
depleted before we are able to generate meaningful data, we may be unable to improve our existing products, continue the
development of pipeline products or validate product candidates. While we have historically been able to create and maintain a
large sample bank to expand the clinical use of our products and develop new products, we may be unable to do so in the future.
If we were unable to maintain or replenish our sample bank, we may be unable to improve our products or develop new
products.
If our primary clinical laboratory facility becomes damaged or inoperable or we are required to vacate our existing facility,
our ability to conduct our laboratory analysis and pursue our research and development efforts may be jeopardized.
We currently perform all of our testing and store our database of tumor samples at our primary clinical laboratory facility in
Phoenix, Arizona. Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters,
including war, fire, earthquake, power loss, communications failure, terrorism, burglary, public health crises (including
restrictions that may be imposed on businesses by state and local governments under stay-at-home or similar orders and
mandates) or other events, which may make it difficult or impossible for us to perform our testing services for some period of
time or to receive and store samples. The inability to perform tests or to reduce the backlog of sample analysis that could
develop if our facility becomes inoperable, for even a short period of time, may result in the loss of revenue, loss of customers
or harm to our reputation, and we may be unable to regain that revenue, those customers or repair our reputation in the future.
Furthermore, integral parties in our supply chain are operating from single sites, increasing their vulnerability to natural
disasters and man-made disasters or other sudden, unforeseen and severe adverse events.
In addition, the loss of our tumor samples due to such events could limit or prevent our ability to conduct research and
development analysis on existing tests as well as tests in active pipeline development.
While we have a business continuity plan in place, and have completed the build out of an additional laboratory facility in close
proximity to our primary facility to support our growth and provide certain operational redundancy, our facilities and the
equipment we use to perform our testing and research and development could be unavailable or costly and time-consuming to
repair or replace. It would be difficult, time-consuming and expensive to rebuild our facilities, to locate and qualify a new
facility, replace certain pieces of equipment or license or transfer our proprietary technology to a third-party, particularly in
light of licensure and accreditation requirements. Even in the unlikely event that we are able to find a third party with such
qualifications to enable us to resume our operations, we may be unable to negotiate commercially reasonable terms.
We carry insurance for damage to our property and the disruption of our business, but this insurance may not cover all of the
risks associated with damage or disruption to our business, may not provide coverage in amounts sufficient to cover our
potential losses and may not continue to be available to us on acceptable terms, if at all.
40
Our current or future products may not achieve or maintain significant commercial market acceptance.
We believe our commercial success is dependent upon our ability to continue to successfully market and sell our products, to
continue to expand our current relationships and develop new relationships with healthcare providers, to expand and maintain
coverage for our products, and to develop and commercialize new products. Our ability to achieve and maintain commercial
market acceptance of our existing and future products will depend on a number of factors, including:
•
•
•
•
•
•
•
•
•
•
our ability to increase awareness of our products through successful clinical utility and validity studies;
the rate of adoption of our products by physicians and other healthcare providers;
our ability to achieve guideline inclusion for our products;
the timeliness with which we can provide our clinical reports to the ordering physician;
the timing and scope of any regulatory approval for our products, if such approvals become required, and maintaining
ongoing compliance with regulatory requirements;
our ability to obtain and maintain positive coverage decisions for our products from government and commercial
payors;
our ability to obtain and maintain adequate reimbursement from third-party payors, including Medicare, Medicare
Advantage plans and BlueCross BlueShield plans, which accounted for an aggregate of approximately 93% and 84%
of our total revenue for the years ended December 31, 2020 and 2019, respectively;
the impact of our investments in research and development and commercial growth;
negative publicity regarding our or our competitors’ products resulting from scientific publications, or defects or errors
in the products; and
our ability to further validate our products through clinical research and accompanying publications.
We cannot assure you that we will be successful in addressing each of these factors or other factors that might affect the market
acceptance of our products. If we are unsuccessful in achieving and maintaining market acceptance of our products, our
business and results of operations will suffer.
New product development involves a lengthy and complex process, and we may be unable to develop and commercialize, or
receive reimbursement for, on a timely basis, or at all, new products.
We continually seek to develop new product offerings, which requires us to devote considerable resources to research and
development. For example, before we can commercialize a new pipeline product, we will need to expend significant resources
in order to conduct substantial research and development, including clinical utility and validity studies, and further develop and
scale our laboratory processes and infrastructure to accommodate additional products.
Our product development process takes time and involves a high degree of risk, and such development efforts may fail for
many reasons, including failure of the product to perform as expected, failure to successfully complete analytic and clinical
validation, or failure to demonstrate the clinical utility of the product.
As we develop new products, we will have to make significant investments in research and development, marketing, selling,
coverage and reimbursement activities. Typically, few research and development projects result in a commercialized product,
and there can be no assurance that we will be able to successfully develop new products that can be commercialized. At any
point, we may abandon development of a product or we may be required to expend considerable resources conducting research,
which would adversely affect the timing for generating potential revenue from a new product and our ability to invest in other
products in our pipeline. If a clinical validation study fails to demonstrate the prospectively defined endpoints of the study or if
we fail to sufficiently demonstrate analytical validity or clinical utility, we might choose to abandon the development of the
product, which could harm our business. In addition, competitors may develop and commercialize competing products or
technologies faster than us or at a lower cost.
We may experience limits on our revenue if we are unable to increase and support adoption of our products by physicians
and other healthcare providers.
Physicians and other healthcare providers may be unwilling to adopt our products due to their reliance on existing traditional
clinical and pathology staging criteria and our ability to generate revenue from our products would be significantly impaired if
we were unable to educate physicians, healthcare providers, patients and third-party payors about the benefits and advantages of
our products. The COVID-19 crisis has impacted our in-person healthcare interactions, such as field-based sales and medical
affairs, and we have had to convert visits, programs and projects to be performed online and by telephone. Due to the
41
uncertainties surrounding the duration, extent and lingering impacts of the COVID-19 crisis, our in-person healthcare
interactions may continue to be limited and this may impact the effectiveness of our efforts. We will need to continue to educate
physicians and pathologists about the benefits and cost-effectiveness of our products through published papers, presentations at
scientific conferences, one-on-one marketing efforts by our sales force and one-on-one education by our medical affairs team.
However, physicians and other healthcare providers may be reluctant to adopt our products in circumstances where our
products are not incorporated into the current standard of care or practice guidelines. For example, while clinical utility of
DecisionDx-Melanoma has been demonstrated in peer reviewed publications, the SLNB surgery is the most widely used
staging tool for determining a cutaneous melanoma patient’s metastatic risk. Whether healthcare providers adopt DecisionDx-
Melanoma as a complementary or triage diagnostic method relative to the SLNB surgery will depend on our ability to increase
awareness of DecisionDx-Melanoma and its clinical validation.
In addition, our testing services are performed by our certified laboratory located in Phoenix, Arizona, under CLIA, rather than
by local laboratory or pathology practices. Accordingly, it may be difficult for us to collect samples from pathologists, and
pathologists may be reluctant to support our testing services.
We rely on limited or sole suppliers for some of the reagents, equipment, chips and other materials used by our products,
and we may not be able to find replacements or transition to alternative suppliers.
We rely on limited or sole suppliers for certain reagents and other materials and components that we use for our products. Some
of these items are unique to these suppliers and vendors. While we have developed alternate sourcing strategies for these
materials and vendors, we cannot be certain whether these strategies will be effective or the alternative sources will be available
when we need them. If these suppliers can no longer provide us with the materials we need, if the materials do not meet our
quality specifications or are otherwise unusable, if we cannot obtain acceptable substitute materials, or if we elect to change
suppliers, an interruption in laboratory operations could occur, we may not be able to deliver patient reports on a timely basis,
or at all, and we may incur higher one-time switching costs. Any such interruption may significantly affect our future revenue,
cause us to incur higher costs, and harm our customer relationships and reputation. In addition, in order to mitigate these risks,
we maintain inventories of these supplies at higher levels than would be the case if multiple sources of supply were available. If
our testing volume decreases or we switch suppliers, we may hold excess supplies with expiration dates that occur before use
which would adversely affect our losses and cash flow position. As we introduce any new products, we may experience supply
issues as we ramp test volume. If we should encounter delays or difficulties in securing, reconfiguring or revalidating the
equipment, reagents or other materials we require for our products, our business, financial condition, results of operations and
reputation could be adversely affected.
If our products do not meet the expectations of physicians and patients, our operating results, reputation and business could
suffer.
Our success depends on physician and patient confidence that we can provide reliable, high-quality information that will
improve treatment outcomes, lower healthcare costs and enable better patient care. We believe that patients, physicians and
other healthcare providers are likely to be particularly sensitive to defects and errors in our products, including if our products
fail to accurately predict risk of metastasis with high accuracy from samples, and there can be no guarantee that our products
will meet their expectations. As a result, the failure of our products to perform as expected could significantly impair our
operating results and our reputation, including if we become subject to legal claims arising from any defects or errors in our
products or reports.
If we are unable to compete successfully, our business will suffer and we may be unable to increase or sustain our revenue
or achieve profitability.
We face competition from companies and academic institutions that have either developed or may seek to develop products
intended to compete with our products. Potential competitors within the broader genomics profiling space based on tissue
sample collection include laboratory companies such as Laboratory Corporation of America and Myriad Genetics, and other
companies which have strong infrastructures capable of supporting the commercialization of diagnostic services.
In addition, competitors may develop their own versions of our solutions in countries where we do not have patents or where
our intellectual property rights are not recognized and compete with us in those countries, including encouraging the use of their
solutions by physicians in other countries.
Some potential competitors may have longer operating histories, larger customer bases, greater brand recognition and market
penetration, substantially greater financial, technological and research and development resources and selling and marketing
capabilities, and more experience dealing with third-party payors. As a result, they may be able to respond more quickly to
changes in customer requirements, devote greater resources to the development, promotion and sale of their products than we
do or sell their products at prices designed to win significant levels of market share. We may not be able to compete effectively
42
against these organizations. Increased competition and cost-saving initiatives on the part of governmental entities and other
third-party payors are likely to result in pricing pressures, which could harm our sales, profitability or ability to gain market
share. In addition, competitors may be acquired by, receive investments from or enter into other commercial relationships with
larger, well-established and well-financed companies. Certain potential competitors may be able to secure key inputs from
vendors on more favorable terms, devote greater resources to marketing and promotional campaigns, adopt more aggressive
pricing policies and devote substantially more resources to test development than we can. In addition, companies or
governments that control access to testing through umbrella contracts or regional preferences could promote our competitors or
prevent us from performing certain services. If we are unable to compete successfully against current and future competitors,
our business will suffer and we may be unable to increase market acceptance and sales of our products, which could prevent us
from increasing our revenue or achieving profitability and could cause our stock price to decline. As we add new tests and
services, we will face many of these same competitive risks for these new tests.
The sizes of the markets for our current and future products have not been established with precision and may be smaller
than we estimate.
Our estimates of the total addressable markets for DecisionDx-Melanoma, DecisionDx-UM, DecisionDx-SCC and DecisionDx
DiffDx-Melanoma are based on a number of internal and third-party estimates, including, without limitation, the annual rate of
patients with the applicable form of skin cancer, the list price of our products relative to the reimbursement we expect to receive
from third-party payors and the assumed prices at which we can sell our products in markets that have not been established. For
example, we estimate that the total addressable market for DecisionDx-Melanoma is approximately $540 million, which is
based, in part, on our review of multiple publications which show that diagnosis of melanoma is underreported by 30% to 72%.
While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may
not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the
predictive accuracy of these underlying factors. As a result, our estimates of the annual total addressable market for our current
or future products may prove to be incorrect. If the actual number of patients who would benefit from our products, the price at
which we can sell future products, or the annual total addressable market for our products is smaller than we have estimated, it
may impair our sales growth and have an adverse impact on our business.
The diagnostic testing industry is subject to rapid change, which could make our current or future products obsolete.
Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product
introductions and enhancements and evolving industry standards, all of which could make our current products and the other
products we are developing obsolete. Our future success will depend on our ability to keep pace with the evolving needs of
physicians and patients on a timely and cost-effective basis and to pursue new market opportunities that develop as a result of
scientific and technological advances. In recent years, there have been numerous advances in technologies relating to the
diagnosis and treatment of cancer. There have also been advances in methods used to analyze very large amounts of molecular
information. We must continuously enhance our existing products and develop new products to keep pace with evolving
standards of care. If we do not update our products to reflect new scientific knowledge about cancer biology, information about
new cancer therapies or relevant clinical studies, our products could become obsolete and sales of our current products and any
new products we develop could decline or fail to grow as expected.
Risks Related to Reimbursement and Government Regulation
We currently have limited reimbursement coverage for our lead product, DecisionDx-Melanoma, and if third-party payors,
including government and commercial payors, do not provide sufficient coverage of, or adequate reimbursement for, our
products, our commercial success, including revenue, will be negatively affected.
Our revenue depends on achieving broad coverage and adequate reimbursement for our products from third-party payors,
including both government and commercial third-party payors. If third-party payors do not provide coverage of, or do not
provide adequate reimbursement for, a substantial portion of the list price of our products, we may need to seek additional
payment from the patient beyond any co-payments and deductibles, which may adversely affect demand for our products.
Coverage determinations by a third-party payor may depend on a number of factors, including, but not limited to, a third-party
payor’s determination of whether our products are appropriate, medically necessary or cost-effective. If we are unable to
provide third-party payors with sufficient evidence of the clinical utility and validity of our products, they may not provide
coverage, or may provide limited coverage, which will adversely affect our revenues and our ability to succeed. To the extent
that more competitors enter our markets, the availability of coverage and the reimbursement rate for our products may decrease
as we encounter pricing pressure from these competitors.
Since each third-party payor makes its own decision as to whether to establish a policy to cover our products, enter into a
contract with us and set the amount it will reimburse for a product, these negotiations are a time-consuming and costly process,
43
and they do not guarantee that the third-party payor will provide coverage or adequate reimbursement for our products. In
addition, the determinations by a third-party payor whether to cover our products and the amount it will reimburse for them are
often made on an indication-by-indication basis.
In cases where there is no coverage policy or we do not have a contracted rate for reimbursement as a participating provider, the
patient is typically responsible for a greater share of the cost of the product, which may result in further delay of our revenue,
increase our collection costs or decrease the likelihood of collection.
Our claims for reimbursement from third-party payors may be denied upon submission, and we may need to take additional
steps to receive payment, such as appealing the denials. Such appeals and other processes are time-consuming and expensive,
and may not result in payment. Third-party payors may perform audits of historically paid claims and attempt to recoup funds
years after the funds were initially distributed if the third-party payors believe the funds were paid in error or determine that our
products were medically unnecessary. If a third-party payor audits our claims and issues a negative audit finding, and we are
not able to overturn the audit findings through appeal, the recoupment may result in a material adverse effect on our revenue.
Additionally, in some cases commercial third-party payors for whom we are not a participating provider may elect at any time
to review claims previously paid and determine the amount they paid was too much. In these situations, the third-party payor
will typically notify us of their decision and then offset whatever amount they determine they overpaid against amounts they
owe us on current claims. We cannot predict when, or how often, a third-party payor might engage in these reviews and we may
not be able to dispute these retroactive adjustments.
Under ASC 606, we recognize revenue at the amount we expect to be entitled, subject to a constraint for variable consideration,
in the period in which our tests are delivered to the treating physician. We have determined that our contracts contain variable
consideration under ASC 606 because the amounts paid by third-party payors may be paid at less than our standard rates or not
paid at all, with such differences considered implicit price concessions. Variable consideration is recognized only to the extent
it is probable that a significant reversal of revenue will not occur in future periods when the uncertainties are resolved.
Variable consideration is evaluated each reporting period and adjustments are recorded as increases or decreases in revenues.
Variable consideration for Medicare claims that are not covered by an LCD, including those claims subject to approval by an
ALJ at an appeal hearing, is deemed to be fully constrained due to factors outside our influence (i.e., judgment or actions of
third parties) and the uncertainty of the amount to be received is not expected to be resolved for a long period of time. For these
fully constrained claims, we generally recognize revenue in the period the uncertainties are resolved, if favorable. In June 2017
we submitted to the Office of Medicare Hearings and Appeals, or OMHA, a request to participate in an appeal program
developed with the intent of providing appellants a means to have large volumes of claim disputes adjudicated at an accelerated
rate. We submitted 2,698 DecisionDx-Melanoma claims dating from 2013 through spring 2017 for adjudication on a
consolidated basis. In March 2020, OMHA issued a decision denying payment on all of these claims. In accordance with ASC
606 and consistent with prior periods, we have not recognized (fully constrained the variable consideration) any revenues
attributable to these claims in our financial statements pending the outcome of this matter. We have appealed this decision, but
there can be no assurances regarding the timing or the outcome of this or any other appeal decision. Due to potential future
changes in Medicare coverage policies and appeal cycles, insurance coverage policies, contractual rates and other trends in the
reimbursement of our tests, our revenues may fluctuate significantly from period to period.
Although we are an in-network participating provider with some commercial third-party payors, including several Blue Cross
Blue Shield plans, and certain large, national commercial third-party payors, including Aetna, other commercial third-party
payors have issued non-coverage policies that currently categorize DecisionDx-UM and DecisionDx-Melanoma as
experimental or investigational. If we are not successful in obtaining coverage from third-party payors, in reversing existing
non-coverage policies, or if other third-party payors issue similar non-coverage policies, this could have a material adverse
effect on our business and operations.
Palmetto, the MAC responsible for administering MolDX, the program that assesses molecular diagnostic technologies, issued
a final LCD for DecisionDx-Melanoma, which became effective on December 3, 2018 and issued a final expanded LCD
effective November 22, 2020. This LCD provides for coverage of DecisionDx-Melanoma for certain SLNB-eligible patients
with cutaneous melanoma tumors with clinically negative sentinel node basins who are being considered for SLNB to
determine eligibility for adjuvant therapy. The final expanded LCD also covers use of DecisionDx-Melanoma by physicians for
assessment of appropriate treatment plans, regardless of the decision to undergo or avoid the SLNB surgery. Similarly, Palmetto
issued a final LCD for DecisionDx-UM effective July 10, 2017. This LCD provides for coverage of DecisionDx-UM to
determine metastatic risk in connection with the management of a patient’s newly diagnosed uveal melanoma and to guide
surveillance and referral to medical oncology for those patients. We worked with Palmetto to obtain these positive coverage
44
decisions through the submission of a detailed dossier of analytical and clinical data to substantiate that the tests meet
Medicare’s medical necessity requirements. Per their joint operating agreement, Noridian, the MAC responsible for
administering claims for laboratory services performed in Arizona, has adopted the same coverage policy as Palmetto for
DecisionDx-UM and DecisionDx-Melanoma. This coverage process is lengthy, time-consuming, has changed over time, may
change in the future and requires significant dedication of resources, and as we develop new products, we may be unsuccessful
in receiving LCD determinations for those products or in maintaining our current LCDs. On a periodic basis, CMS requests
bids for its MAC services, and MAC jurisdictions have changed in the past. A change in our MAC, or future changes in the
MolDX program, the elimination of the program, or a change in the administrator of that program, may affect our ability to
obtain Medicare coverage and reimbursement for products for which we have coverage, for products for which we do not yet
have coverage, or for any products we may launch in the future, or delay payments for our tests.
Under Medicare, payment for products like ours is generally made under the CLFS, with payment amounts assigned to specific
procedure billing codes. In April 2014, Congress passed PAMA, which included substantial changes to the way in which
clinical laboratory services are paid under Medicare. Under PAMA, certain laboratories are required to report to CMS
commercial third-party payor payment rates and volumes for each test they perform. CMS uses this data to calculate a weighted
median payment rate for each test, which will be used to establish revised Medicare CLFS reimbursement rates for the test.
Laboratories that fail to report the required payment information may be subject to substantial civil monetary penalties. We bill
Medicare for our products, and therefore we are subject to reporting requirements under PAMA.
On May 17, 2019, CMS determined that DecisionDx-UM meets the criteria for “existing ADLT” status. This means that
beginning in 2021, the DecisionDx-UM Medicare rate will be set annually based upon the median private payor rate for the first
half of the second preceding calendar year. Note that our rate for 2020 was set by Noridian, our local MAC, but our rate for
2021 for DecisionDx-UM will be $7,776 based on the median private payor rate. Also, on May 17, 2019, CMS determined that
DecisionDx-Melanoma meets the criteria for “new ADLT” status. Accordingly, from July 1, 2019 through March 31, 2020 the
Medicare reimbursement rate was equal to the initial list price of $7,193. From April 1, 2020 through December 31, 2021, CMS
notified us that the rate will also be $7,193, which was calculated based upon the median private payor rate for DecisionDx-
Melanoma from July 1, 2019 to November 30, 2019. Beginning in 2022, the rate for both DecisionDx-Melanoma and
DecisionDx-UM will be set annually based upon the median private payor rate for the first half of the second preceding
calendar year. For example, the rate for 2022 will be set using median private payor rate data from January 1, 2020 to June 30,
2020.
In the second quarter of 2020, we submitted our technical assessment dossier for DecisionDx-SCC to Palmetto and Noridian. In
early 2021, we submitted our technical assessment dossier for DecisionDx DiffDx-Melanoma. We expect that draft LCDs for
each of these tests will be posted in 2021. However, there is no assurance that the timing of any draft LCD or final LCD will
match our expectations or our historical experience with LCDs for our other tests.
If we are unable to obtain and maintain adequate reimbursement rates from commercial third-party payors, this may adversely
affect our Medicare rate. It is unclear what impact new pricing structures, such as those adopted under PAMA, may have on our
business, financial condition, results of operations or cash flows.
The U.S. federal government continues to show significant interest in pursuing health care reform and reducing health care
costs. Similarly, commercial third-party payors may seek to reduce costs by limiting coverage or reducing reimbursement for
our products. Any government-adopted reform measures or changes to commercial third-party payor coverage and
reimbursement policies could cause significant pressure on the pricing of, and reimbursement for, health care products and
services, including our products, which could decrease demand for our products, and adversely affect our sales and revenue.
In addition, some third-party payors have implemented, or are in the process of implementing, laboratory benefit management
programs, often using third-party benefit managers to manage these programs. The stated goals of these programs are to help
improve the quality of outpatient laboratory services, support evidence-based guidelines for patient care and lower costs. The
impact on laboratories, such as ours, of active laboratory benefit management by third parties is unclear, and we expect that it
could have a negative impact on our revenue in the short term. It is possible that third-party payors will resist reimbursement for
the products that we offer, in favor of less expensive products, may require pre-approval for our products or may impose
additional pricing pressure on and substantial administrative burden for reimbursement for our products.
We expect to continue to focus substantial resources on increasing coverage and reimbursement for our current products and
any future products we may develop. We believe it may take several years to achieve broad coverage and adequate contracted
reimbursement with a majority of third-party payors for our products.
45
However, we cannot predict whether, under what circumstances, or at what payment levels third-party payors will cover and
reimburse our products. If we fail to establish and maintain broad adoption of, and coverage and reimbursement for, our
products, our ability to generate revenue could be harmed and our future prospects and our business could suffer.
Our products are currently marketed as laboratory developed tests, and any changes in regulations or the FDA’s
enforcement discretion for laboratory developed tests, or violations of regulations by us, could adversely affect our business,
prospects, results of operations or financial condition.
The diagnostics industry is highly regulated, and we cannot assure you that the regulatory environment in which we operate will
not change significantly and adversely in the future. In many instances, there are no significant regulatory or judicial
interpretations of these laws and regulations. Although the FDA has statutory authority to assure that medical devices are safe
and effective for their intended uses, the FDA has generally exercised its enforcement discretion and not enforced applicable
regulations with respect to in vitro diagnostics that are designed, manufactured and used within a single laboratory. These tests
are referred to as LDTs. We currently market our products as LDTs.
The FDA has adopted a policy of enforcement discretion with respect to LDTs whereby the FDA does not actively require
premarket review of LDTs or otherwise impose its requirements applicable to other medical devices on LDTs. However, the
FDA has stated its intention to modify its enforcement discretion policy with respect to LDTs. The FDA could ultimately
modify its current approach to LDTs in a way that would subject our products marketed as LDTs to the enforcement of
additional regulatory requirements. Moreover, legislative measures have recently been proposed in Congress that, if ultimately
enacted, could provide the FDA with additional authority to require premarket review of and regulate LDTs. If and when such
changes to the regulatory framework occur, we could for the first time be subject to enforcement of regulatory requirements as a
device manufacturer such as registration and listing requirements, medical device reporting requirements and the requirements
of the FDA’s Quality System Regulation. We may be required to conduct clinical trials prior to continuing to sell our existing
products or launching any other products we may develop. This may increase the cost of conducting, or otherwise harm, our
business.
Moreover, even if the FDA does not modify its policy of enforcement discretion, the FDA may disagree that we are marketing
our LDTs within the scope of its policy of enforcement discretion and may impose significant regulatory requirements. While
we believe that we are currently in material compliance with applicable laws and regulations as historically enforced by the
FDA, we cannot assure you that the FDA will agree with our determination. A determination that we have violated these laws
and regulations, or a public announcement that we are being investigated for possible violations, could adversely affect our
business, prospects, results of operations or financial condition.
If the FDA begins to actively regulate our diagnostic products, we may be required to obtain premarket clearance under Section
510(k) of FDCA or a PMA. The process for submitting a 510(k) premarket notification and receiving FDA clearance usually
takes from three to 12 months, but it can take significantly longer and clearance is never guaranteed. The process for submitting
and obtaining FDA approval of a PMA is much more costly, lengthy and uncertain. It generally takes from one to three years or
even longer, and approval is not guaranteed. PMA approval typically requires extensive clinical data and can be significantly
longer, more expensive and more uncertain than the 510(k) clearance process. Despite the time, effort and expense expended,
there can be no assurance that a particular device ultimately will be cleared or approved by the FDA through either the 510(k)
clearance process or the PMA process on a timely basis, or at all. Moreover, there can be no assurance that any cleared or
approved labeling claims will be consistent with our current claims or adequate to support continued adoption of and
reimbursement for our products. If premarket review is required for some or all of our products, the FDA may require that we
stop selling our products pending clearance or approval, which would negatively impact our business. Even if our products are
allowed to remain on the market prior to clearance or approval, demand or reimbursement for our products may decline if there
is uncertainty about our products, if we are required to label our products as investigational by the FDA, or if the FDA limits
the labeling claims we are permitted to make for our products. As a result, we could experience significantly increased
development costs and a delay in generating additional revenue from our products, or from other products now in development.
If the FDA imposes significant changes to the regulation of LDTs it could reduce our revenues or increase our costs and
adversely affect our business, prospects, results of operations or financial condition.
We conduct business in a heavily regulated industry, and failure to comply with federal, state and foreign laboratory
licensing requirements and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose
46
the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial
sanctions.
The diagnostics industry is highly regulated, and the laws and regulations governing the marketing of diagnostic tests are
extremely complex. Areas of the regulatory environment that may affect our ability to conduct business include, without
limitation:
•
•
•
•
•
•
•
•
•
•
federal and state laws applicable to test ordering, documentation of tests ordered, billing practices and claims payment
and/or regulatory agencies enforcing those laws and regulations;
federal and state fraud and abuse laws;
federal and state laboratory anti-mark-up laws;
coverage and reimbursement levels by Medicare, Medicaid, other governmental payors and private insurers;
restrictions on coverage of and reimbursement for tests;
federal and state laws governing laboratory testing, including CLIA, and state licensing laws and accreditation
requirements;
federal and state laws and enforcement policies governing the development, use and distribution of diagnostic medical
devices, including LDTs;
federal, state and local laws governing the handling and disposal of medical and hazardous waste;
federal and state Occupational Safety and Health Administration rules and regulations; and
HIPAA and similar state data privacy laws.
In particular, the FDCA defines a medical device to include any instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
Our products are considered by the FDA to be subject to regulation as medical devices, and marketed under FDA’s policy of
enforcement discretion for LDTs. Among other things, pursuant to the FDCA and its implementing regulations, the FDA
regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval,
marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products
distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the import and export of
medical devices manufactured between the United States and international markets.
We are also subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from
humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA regulations
establish specific standards with respect to personnel qualifications, facility administration, proficiency testing, quality control,
quality assurance and inspections. Any testing subject to CLIA regulation must be performed in a CLIA certified or accredited
lab. CLIA certification or accreditation is also required in order for us to be eligible to bill state and federal healthcare
programs, as well as commercial third-party payors, for our products.
We have a current CLIA accreditation under the College of American Pathologists, or CAP, program to conduct our tests at our
clinical reference laboratory in Phoenix, Arizona. CAP maintains a clinical laboratory accreditation program. While not
required for the operation of a CLIA-certified laboratory, many private insurers require CAP accreditation as a condition to
contracting with clinical laboratories to cover their tests. In addition, some countries outside the United States require CAP
accreditation as a condition to permitting clinical laboratories to test samples taken from their citizens. CAP accredited
laboratories are surveyed for compliance with CAP standards every two years in order to maintain accreditation. Failure to
maintain CAP accreditation could have a material adverse effect on the sales of our products and the results of our operations.
Therefore, to maintain our CLIA accreditation, we have elected to be subject to survey and inspection every two years by CAP.
Moreover, CLIA inspectors may make random inspections of our laboratory from time to time.
Our most recent CAP inspection occurred in the fourth quarter of 2020 and our CLIA accreditation certificate expires on
December 20, 2022.
In addition, certain states require our laboratory to be licensed in such states in order to test specimens from those states.
Accordingly, our laboratory is also licensed by California, Maryland, New York, Pennsylvania and Rhode Island. Other states
may have similar requirements or may adopt similar requirements in the future.
47
Although we have obtained licenses from states where we believe we are required to be licensed, we may become aware of
other states that require out-of-state laboratories to obtain licensure in order to accept specimens from the state, and it is
possible that other states currently have such requirements or will have such requirements in the future.
In order to test specimens from New York, LDTs must be approved by NYSDOH on a test-by-test basis before they are offered.
Our laboratory director must also be separately qualified to be a laboratory director in New York. DecisionDx-Melanoma,
DecisionDx-UM and DecisionDx-PRAME have each been formally approved and we have been granted conditional permission
by NYSDOH to offer our DecisionDx-SCC and DecisionDx DiffDx-Melanoma tests in New York while our applications under
review. Our laboratory director has been qualified by NYSDOH. We are subject to periodic inspection by the NYSDOH and
are required to demonstrate ongoing compliance with NYSDOH regulations and standards. To the extent NYSDOH identified
any non-compliance and we are unable to remedy such non-compliance, the State of New York could withdraw approval for
our products. We will need to seek NYSDOH approval of any future LDTs we develop and want to offer for clinical testing to
New York residents, and there can be no assurance that we will be able to obtain such approval.
We may also be subject to regulation in foreign jurisdictions as we seek to expand international utilization of our products or
such jurisdictions adopt new licensure requirements, which may require review of our products in order to offer them or may
have other limitations such as restrictions on the transport of human tissue samples necessary for us to perform our tests that
may limit our ability to make our products available outside of the United States. Complying with licensure requirements in
new jurisdictions may be expensive, time-consuming and subject us to significant and unanticipated delays.
Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions,
including suspension, limitation or revocation of our CLIA accreditation and/or state licenses, imposition of a directed plan of
action, onsite monitoring, civil monetary penalties, criminal sanctions and revocation of the laboratory’s approval to receive
Medicare and Medicaid payment for its services, as well as significant adverse publicity. Any sanction imposed under CLIA, its
implementing regulations, or state or foreign laws or regulations governing clinical laboratory licensure or our failure to renew
our CLIA accreditation, or a state or foreign license, could have a material adverse effect on our business, financial condition
and results of operations. Even if we were able to bring our laboratory back into compliance, we could incur significant
expenses and potentially lose revenue in doing so.
The FDA may modify its enforcement discretion policy with respect to LDTs in a risk-based manner, and we may become
subject to extensive regulatory requirements and may be required to conduct additional clinical trials prior to continuing to
sell our existing tests or launching any other tests we may develop, which may increase the cost of conducting, or otherwise
harm, our business.
If the FDA changes or ends its policy of enforcement discretion with respect to LDTs, and our products become subject to the
FDA’s requirements for premarket review of medical devices, we may be required to cease commercial sales of our products
and conduct clinical trials prior to making submissions to the FDA to obtain premarket clearance or approval. If we are required
to conduct such clinical trials, delays in the commencement or completion of clinical trials could significantly increase our
product development costs and delay commercialization of any currently marketed testing that we may be required to cease
selling or the commercialization of any future tests that we may develop. Many of the factors that may cause or lead to a delay
in the commencement or completion of clinical trials may also ultimately lead to delay or denial of regulatory clearance or
approval. The commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of
many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites
and the eligibility criteria for the clinical trial.
The FDA requires medical device manufacturers to comply with, among other things, current good manufacturing practices for
medical devices, known as the Quality System Regulation, which requires manufacturers to follow elaborate design, testing,
control, documentation and other quality assurance procedures during the manufacturing process; the medical device reporting
regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or
serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;
labeling regulations, including the FDA’s general prohibition against promoting products for unapproved or ‘‘off-label’’ uses;
and the reports of corrections and removals regulation, which requires manufacturers to report to the FDA if a device correction
or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA caused by the
device which may present a risk to health.
Even if we were able to obtain FDA clearance or approval for one or more of our products, if required, a diagnostic test may be
subject to limitations on the indications for which it may be marketed or to other regulatory conditions. In addition, such
clearance or approval may contain requirements for costly post-market testing and surveillance to monitor the safety or efficacy
of the test.
48
In addition, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be
enacted that could prevent, limit or delay regulatory approvals. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may
lose any marketing authorization that we may have obtained and we may not achieve or sustain profitability, which would
adversely affect our business, prospects, financial condition and results of operations.
Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change
as more data become available and are subject to audit and verification procedures that could result in material changes in
the final data.
From time to time, we may publicly disclose preliminary or topline or data from our clinical studies, which is based on a
preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following
a more comprehensive review of the data related to the particular study. We also make assumptions, estimations, calculations
and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully
evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different
conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline
data also remain subject to audit and verification procedures that may result in the final data being materially different from the
preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are
available. From time to time, we may also disclose interim data from our clinical studies. Interim data from clinical studies that
we may complete are subject to the risk that one or more of the clinical outcomes may materially change as more patient data
become available. Adverse differences between preliminary or interim data and final data could significantly harm our
reputation and marketing efforts.
Further, others, including healthcare providers or payors, may not accept or agree with our assumptions, estimates, calculations,
conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the
particular program, the approvability or commercialization of the particular product candidate or product and our company in
general. In addition, the information we choose to publicly disclose regarding a particular study is based on what is typically
extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate
information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed
significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business. If the topline or
interim data that we report differ from actual results, or if others, including healthcare providers or payors, disagree with the
conclusions reached, our ability to commercialize, our product candidates may be harmed, which could harm our business,
operating results, prospects or financial condition.
Changes in health care policy could increase our costs, decrease our revenues and impact sales of and reimbursement for
our products.
In March 2010, the ACA became law. This law substantially changed the way health care is financed by both government and
commercial third-party payors, and significantly impacted our industry. The ACA contains a number of provisions that are
expected to impact our business and operations, some of which in ways we cannot currently predict, including those governing
enrollment in state and federal health care programs, reimbursement changes and fraud and abuse, which impact existing state
and federal health care programs and will result in the development of new programs. Among other things, the ACA required
medical device manufacturers to pay a sales tax equal to 2.3% of the price for which such manufacturer sells its medical
devices, and began to apply to sales of taxable medical devices after December 31, 2012, but was suspended in 2016. Further,
the 2020 federal spending package permanently eliminated, effective January 1, 2020, the medical device tax and “Cadillac” tax
on high-cost employer-sponsored health coverage and, effective January 1, 2021, also eliminated the health insurer tax.
Since 2016, there have been efforts to repeal all or part of the ACA, and the previous administration and the U.S. Congress have
taken action to roll back certain provisions of the ACA. It is unknown what actions, if any, the current administration and the
U.S. Congress may take regarding the ACA.
Additionally, on December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety
because the tax penalty on certain individuals who fail to maintain qualifying health coverage for all or part of a year,
commonly referred to as the ‘‘individual mandate,’’ was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017, or
the TCJA. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit ruled that the individual mandate
was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the
ACA are invalid as well. The United States Supreme Court is currently reviewing this case. It is unclear when a decision in this
case will be made. It is also unclear how the Supreme Court ruling, other such litigation and the healthcare reform measures of
the Biden administration will impact the ACA and our business.
49
On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare
payments to providers by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to the
statute, will remain in effect through 2030, unless additional Congressional action is taken. The Coronavirus Aid, Relief and
Economic Security Act enacted on March 27, 2020, also known as the CARES Act, which is designed to provide financial
support and resources to individuals and business affected by the COVID-19 pandemic, suspended the 2% Medicare sequester
from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030. The Consolidated
Appropriations Act, 2021, which was signed into law on December 27, 2020, extended the suspension of the 2% Medicare
sequester through March 31, 2021.
We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial
third-party payors to reduce costs while expanding individual healthcare benefits. For example, it is possible that additional
governmental action is taken in response to the COVID-19 crisis. Certain of these changes could impose additional limitations
on the prices we will be able to charge for our products, the coverage of or the amounts of reimbursement available for our
products from third-party payors, including government and commercial payors.
We are subject to numerous federal and state healthcare statutes and regulations, and complying with laws pertaining to our
business is an expensive and time-consuming process. If we are unable to comply, or have not fully complied, with such
laws, we could face substantial penalties and a material adverse effect to our business and operations.
Physicians, other healthcare providers and third-party payors play a primary role in the recommendation of our products. Our
arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable fraud and abuse
and other healthcare laws and regulations that affect the business and financial arrangements and relationships through which
we market and sell our products. The laws that affect our ability to operate include, but are not limited to:
•
•
•
the AKS, which prohibits, among other things, any person or entity from knowingly and willfully soliciting, receiving,
offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward
either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in
whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term
‘‘remuneration’’ has been broadly interpreted to include anything of value, such as specimen collection materials or
test kits. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities
from prosecution, however these are drawn narrowly. Additionally, a person or entity does not need to have actual
knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to
civil and criminal fines and monetary penalties of up to $100,000 for each violation, plus up to three times the
remuneration involved, imprisonment of up to ten years and exclusion from government healthcare programs. In
addition, the ACA codified case law that a claim including items or services resulting from a violation of the AKS
constitutes a false or fraudulent claim for purposes of the FCA;
the Stark Law, which prohibits a physician from making a referral for certain designated health services covered by the
Medicare or Medicaid program, including laboratory and pathology services, if the physician or an immediate family
member of the physician has a financial relationship with the entity providing the designated health services and
prohibits that entity from billing, presenting or causing to be presented a claim for the designated health services
furnished pursuant to the prohibited referral, unless an exception applies. Sanctions for violating the Stark Law include
denial of payment, civil monetary penalties and exclusion from the federal health care programs. Failure to refund
amounts received as a result of a prohibited referral on a timely basis may constitute a false or fraudulent claim and
may result in civil penalties and additional penalties under the FCA;
federal civil and criminal false claims laws, such as the FCA, which can be enforced by private citizens through civil
qui tam action, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly
presenting, or causing to be presented through distribution of template medical necessity language or other coverage
and reimbursement information, false, fictitious or fraudulent claims for payment or approval by the federal
government, including federal health care programs, such as Medicare and Medicaid, and knowingly making, using or
causing to be made or used a false record or statement material to a false or fraudulent claim, or knowingly making a
false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government. In
addition, a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent
claim for purposes of the FCA. Private individuals can bring False Claims Act ‘‘qui tam’’ actions, on behalf of the
government and such individuals, commonly known as ‘‘whistleblowers,’’ may share in amounts paid by the entity to
the government in fines or settlement. When an entity is determined to have violated the federal civil False Claims Act,
the government may impose civil fines and penalties, plus treble damages, and exclude the entity from participation in
Medicare, Medicaid and other federal healthcare programs;
50
•
•
•
•
•
•
•
•
•
the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, prohibits payments for referrals to recovery homes,
clinical treatment facilities, and laboratories. EKRA’s reach extends beyond federal health care programs to include
private insurance (i.e., it is an “all payor” statute). For purposes of EKRA, the term “laboratory” is defined broadly and
without reference to any connection to substance use disorder treatment. The law includes a limited number of
exceptions, some of which closely align with corresponding federal Anti-Kickback Statute exceptions and safe
harbors, and others that materially differ;
HIPAA, which, among other things, imposes criminal liability for executing or attempting to execute a scheme to
defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or
stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and
knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious
or fraudulent statement or representation, in connection with the delivery of or payment for healthcare benefits, items
or services. Like the AKS, a person or entity does not need to have actual knowledge of the statute or specific intent to
violate it in order to have committed a violation;
HIPAA, as amended by HITECH, and their implementing regulations, which imposes privacy, security and breach
reporting obligations with respect to individually identifiable health information upon entities subject to the law, such
as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their
respective business associates, individuals or entities that perform services for them that involve individually
identifiable health information as well as their covered subcontractors. Failure to comply with the HIPAA privacy and
security standards can result in civil monetary penalties, and, in certain circumstances, criminal penalties. HITECH
also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly
applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or
injunctions in U.S. federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal
civil actions;
state laws that prohibit other specified practices, such as billing physicians for tests that they order or providing tests at
no or discounted cost to induce physician or patient adoption; insurance fraud laws; waiving coinsurance, copayments,
deductibles, and other amounts owed by patients; billing a state Medicaid program at a price that is higher than what is
charged to one or more other third-party payors employing, exercising control over or splitting professional fees with
licensed professionals in violation of state laws prohibiting fee splitting or the corporate practice of medicine and other
professions; and
federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and
activities that potentially harm consumers;
the federal transparency requirements under the Physician Payments Sunshine Act, created under the ACA, which
requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed
under Medicare, Medicaid, or the Children’s Health Insurance Program to annually report to CMS information related
to payments and other transfers of value provided to physicians, certain other healthcare professionals, and teaching
hospitals and physician ownership and investment interests, including such ownership and investment interests held by
a physician’s immediate family members. Beginning in 2022, applicable manufacturers also will be required to report
such information regarding their relationships with physician assistants, nurse practitioners, clinical nurse specialists,
certified registered nurse anesthetists and certified nurse midwives during the previous year. Failure to submit required
information may result in civil monetary penalties for all payments, transfers of value or ownership or investment
interests that are not timely, accurately, and completely reported in an annual submission, and may result in liability
under other federal laws or regulations. We believe that we are exempt from these reporting requirements. We cannot
assure you, however, that our regulators, principally the federal government, will agree with our determination, and a
determination that we have violated these laws and regulations, or a public announcement that we are being
investigated for possible violations, could adversely affect our business;
the prohibition on reassignment of Medicare claims, which, subject to certain exceptions, precludes the reassignment
of Medicare claims to any other part;
state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that
may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by any non-
governmental third-party payors, including private insurers; and
federal, state and foreign laws that govern the privacy and security of health information or PII in certain
circumstances, including state health information privacy and data breach notification laws which govern the
51
collection, use, disclosure, and protection of health-related and other personal information, many of which differ from
each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.
As a clinical laboratory, our business practices may face additional scrutiny from government regulatory agencies such as the
Department of Justice, the OIG and CMS. Certain arrangements between clinical laboratories and referring physicians have
been identified in fraud alerts issued by the OIG as implicating the AKS. The OIG has stated that it is particularly concerned
about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically
are made or strongly influenced by the physician, with little or no input from patients. Moreover, the provision of payments or
other items of value by a clinical laboratory to a referral source could be prohibited under the Stark Law unless the arrangement
meets all criteria of an applicable exception. The government has been active in enforcement of these laws as they apply to
clinical laboratories.
We have entered into consulting and scientific advisory board arrangements, speaking arrangements and clinical research
agreements with physicians and other healthcare providers, including some who could influence the use of our products.
Because of the complex and far-reaching nature of these laws, regulatory agencies may view these transactions as prohibited
arrangements that must be restructured, or discontinued, or for which we could be subject to other significant penalties. We
could be adversely affected if regulatory agencies interpret our financial relationships with providers who may influence the
ordering of and use of our products to be in violation of applicable laws.
The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of
healthcare reform. Federal and state enforcement bodies have recently increased their scrutiny of interactions between
healthcare companies, healthcare providers and other third parties, including charitable foundations, which has led to a number
of investigations, prosecutions, convictions and settlements in the healthcare industry. It is possible that governmental
authorities may conclude that our business practices, including our consulting arrangements with physicians, as well as our
financial assistance programs, do not comply with current or future statutes, regulations, agency guidance or case law involving
applicable healthcare laws. Responding to investigations can be time and resource-consuming and can divert management’s
attention from the business. Any such investigation or settlement could increase our costs or otherwise have an adverse effect
on our business.
Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations is costly. If
our operations are found to be in violation of any of these laws or any other current or future governmental laws and regulations
that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines,
disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid,
contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if
we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these
laws, and the curtailment or restructuring of our operations, any of which could substantially disrupt our operations. If any of
the physicians or other healthcare providers or entities with whom we do business is found to be not in compliance with
applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from
government funded healthcare programs.
We are subject to certain U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and
regulations and may become subject to their similar foreign equivalents. We can face serious consequences for violations.
U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, or
collectively, Trade Laws, prohibit, among other things, companies and their employees, agents, legal counsel, accountants,
consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving, directly or
indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector.
Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges,
debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have
direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals,
universities, and other organizations. We also expect that we may engage in non-U.S. activities over time. We expect to rely on
third-party suppliers and/or third parties to obtain necessary permits, licenses, and patent registrations. We can be held liable for
the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior
knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and
criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of
contract and fraud litigation, reputational harm and other consequences.
52
Our collection, use and disclosure of individually identifiable information, including health and/or employee information, is
subject to state, federal and foreign privacy and security regulations, and our failure to comply with those regulations or to
adequately secure the information we hold could result in significant liability or reputational harm.
We and any potential collaborators are subject to federal, state, and foreign data protection laws and regulations (i.e., laws and
regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations,
including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and
federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection,
use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations
of our collaborators.
In the ordinary course of our business, we collect and store sensitive data, including PHI, PII, credit card and other financial
information, intellectual property and proprietary business information owned or controlled by ourselves or our customers,
payors and other parties. We manage and maintain our applications and data utilizing a combination of on-site systems,
managed data centers, and cloud-based data centers. We utilize external security and infrastructure vendors to manage parts of
our data centers.
The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business
strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive
data from unauthorized access, use or disclosure, our information technology and infrastructure may be vulnerable to attacks by
hackers or viruses or breached due to employee error, malfeasance, or other malicious or inadvertent disruptions. Any such
breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized
parties, publicly disclosed, lost, or stolen. Any such access, breach, or other loss of information could result in legal claims or
proceedings, and liability under federal or state laws that protect the privacy of personal information, such as HIPAA, as
amended by HITECH, and regulatory penalties. Notice of breaches must be made to affected individuals, the Secretary of the
Department of Health and Human Services, and for extensive breaches, notice may need to be made to the media or State
Attorneys General. Such a notice could harm our reputation and our ability to compete. Although we have implemented
security measures and a formal, dedicated enterprise security program to prevent unauthorized access to patient data, such data
is currently accessible through multiple channels, and there is no guarantee we can protect our data from breach. Unauthorized
access, loss or dissemination could also disrupt our operations (including our ability to conduct our analyses, provide test
results, bill payers or patients, process claims and appeals, provide customer assistance, conduct research and development
activities, collect, process, and prepare company financial information, provide information about our products and other patient
and physician education and outreach efforts through our website, and manage the administrative aspects of our business) and
damage our reputation, any of which could adversely affect our business. In addition, we may obtain health information from
third parties that are also subject to privacy and security requirements under HIPAA, as amended by HITECH.
Further, various states, such as California and Massachusetts, have implemented similar privacy laws and regulations, such as
the California Confidentiality of Medical Information Act, that impose restrictive requirements regulating the use and
disclosure of health information and other PII. These laws and regulations are not necessarily preempted by HIPAA,
particularly if a state affords greater protection to individuals than HIPAA. Where state laws are more protective, we have to
comply with the stricter provisions. In addition to fines and penalties imposed upon violators, some of these state laws also
afford private rights of action to individuals who believe their personal information has been misused. California’s patient
privacy laws, for example, provide for penalties of up to $250,000 and permit injured parties to sue for damages. The interplay
of federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex
compliance issues for us and our clients and potentially exposing us to additional expense, adverse publicity and liability.
Further, as regulatory focus on privacy issues continues to increase and laws and regulations concerning the protection of
personal information expand and become more complex, these potential risks to our business could intensify. Changes in laws
or regulations associated with the enhanced protection of certain types of sensitive data, such PHI or PII along with increased
customer demands for enhanced data security infrastructure, could greatly increase our cost of providing our services, decrease
demand for our services, reduce our revenue and/or subject us to additional liabilities.
Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous
obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate
in certain jurisdictions. Failure to comply with U.S. and international data protection laws and regulations could result in
government enforcement actions (which could include significant civil, criminal, and administrative penalties), private
litigation, and/or adverse publicity and could negatively affect our operating results and business. Claims that we have violated
individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are
53
not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our
business.
Ethical, legal and social concerns related to the use of genetic information could reduce demand for our products.
Genetic testing has raised ethical, legal, and social issues regarding privacy and the appropriate uses of the resulting
information. Governmental authorities have, through the Genetic Information Nondisclosure Act of 2008, and could further, for
social or other purposes, limit or regulate the use of genetic information or genetic testing or prohibit testing for genetic
predisposition to certain conditions, particularly for those that have no known cure. Ethical and social concerns may also
influence governmental authorities to deny or delay the issuance of patents for technology relevant to our business. While we
do not currently perform genetic tests for genetic predisposition to certain conditions, these concerns may lead patients to refuse
to use, or clinicians to be reluctant to order, our genomic tests or genetic tests for somatic mutations even if permissible. These
and other ethical, legal and social concerns may limit market acceptance of our products or reduce the potential markets for our
products, either of which could have an adverse effect on our business, financial condition, or results of operations.
Risks Related to Intellectual Property
If we are unable to obtain and maintain sufficient intellectual property protection for our technology, or if the scope of the
intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize
diagnostic tests similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection as
well as nondisclosure, confidentiality and other contractual restrictions to protect our brands and proprietary tests and
technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep any
competitive advantage. If we fail to protect our intellectual property, third parties may be able to compete more effectively
against us. In addition, we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual
property.
As is the case with other life science companies, our success depends in large part on our ability to obtain and maintain
protection of the intellectual property we may own solely or jointly with others or in-license from others, particularly patents, in
the United States and other countries with respect to our products and technologies. We apply for patents covering our products
and technologies and uses thereof, as we deem appropriate. However, obtaining and enforcing life sciences patents is costly,
time-consuming and complex, and we may fail to apply for patents on important tests, services and technologies in a timely
fashion or at all, or we may fail to apply for patents in potentially relevant jurisdictions. We may not be able to file and
prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such
patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects
of our research and development output before it is too late to obtain patent protection.
We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to
patents licensed from or to third parties. Therefore, these patents and applications may not be prosecuted and enforced in a
manner consistent with the best interests of our business.
Our patent portfolio includes five issued U.S. patents and six pending U.S. patent applications, with foreign counterparts. It is
possible that none of our pending patent applications will result in issued patents in a timely fashion or at all, and even if patents
are granted, they may not provide a basis for intellectual property protection of commercially viable tests or services, may not
provide us with any competitive advantages, or may be challenged and invalidated by third parties. It is possible that others will
design around our future patented technologies. We may not be successful in defending any such challenges made against our
patents or patent applications. Any successful third-party challenge to our patents could result in the unenforceability or
invalidity of such patents and increased competition to our business. Even if our patents are held valid and enforceable, they
may still be found insufficient to provide protection against competing products and services sufficient to achieve our business
objectives. We may have to challenge the patents or patent applications of third parties, such as to counter infringement or
unauthorized use. In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid or
unenforceable, or may refuse to enjoin the other party from using the technology at issue on the grounds that our patents do not
cover the technology in question. Even if we prevail against an infringer in a U.S. district court or foreign trial-level court, there
is always the risk that the infringer will file an appeal and the initial court judgment will be overturned at the appeals court and/
or that an adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents. The
outcome of patent litigation or other proceeding can be uncertain, and any attempt by us to enforce our patent rights against
others or to challenge the patent rights of others may not be successful, or, if successful, may take substantial time and result in
substantial cost, and may divert our efforts and attention from other aspects of our business.
54
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for
which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in such
companies’ patents has emerged to date in the United States or elsewhere. Courts frequently render opinions in the life sciences
field that may affect the patentability of certain inventions or discoveries, including opinions that may affect the patentability of
methods for analyzing or comparing DNA sequences.
In particular, the patent positions of companies engaged in the development and commercialization of genomic diagnostic tests
are particularly uncertain. Various courts, including the U.S. Supreme Court, have rendered decisions that affect the scope of
patentability of certain inventions or discoveries relating to certain diagnostic tests and related methods. These decisions state,
among other things, that a patent claim that recites an abstract idea, natural phenomenon or law of nature (for example, the
relationship between particular genetic variants and cancer) are not themselves patentable. Precisely what constitutes a law of
nature is uncertain, and it is possible that certain aspects of genetic diagnostics tests would be considered natural laws.
Accordingly, the evolving case law in the United States may adversely affect our ability to obtain patents and may facilitate
third-party challenges to any owned or licensed patents. The laws of some foreign countries do not protect intellectual property
rights to the same extent as the laws of the United States, and we may encounter difficulties in protecting and defending such
rights in foreign jurisdictions. The legal systems of many other countries do not favor the enforcement of patents and other
intellectual property protection, particularly those relating to life science technologies, which could make it difficult for us to
stop the infringement of our patents in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could
result in substantial cost and divert our efforts and attention from other aspects of our business.
To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be
exposed to a greater risk of direct competition, and our competitive position could be adversely affected, as could our business.
Both the patent application process and the process of managing patent disputes can be time-consuming and expensive.
Moreover, if a third party has intellectual property rights that cover the practice of our technology, we may not be able to fully
exercise or extract value from our intellectual property rights. The following examples are illustrative:
•
•
•
•
•
•
•
•
•
•
•
•
others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology,
but that are not covered by the claims of the patents that we own or control, assuming such patents have issued or do
issue;
we or our licensors or any future strategic partners might not have been the first to conceive or reduce to practice the
inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed;
we or our licensors or any future strategic partners might not have been the first to file patent applications covering
certain of our inventions;
others may independently develop similar or alternative technologies or duplicate any of our technologies without
infringing our intellectual property rights;
it is possible that our pending patent applications will not lead to issued patents;
issued patents that we own or have exclusively licensed may not provide us with any competitive advantage, or may be
held invalid or unenforceable, as a result of legal challenges by our competitors;
our competitors might conduct research and development activities in countries where we do not have patent rights and
then use the information learned from such activities to develop competitive tests for sale in our major commercial
markets;
third parties performing manufacturing or testing for us using our products or technologies could use the intellectual
property of others without obtaining a proper license;
parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us
from exercising exclusive rights over that intellectual property;
we may not develop or in-license additional proprietary technologies that are patentable;
we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and
the patents of others may have an adverse effect on our business.
Should any of these events occur, they could significantly harm our business and results of operations.
55
Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby
impairing our ability to protect our products.
As is the case with other life sciences companies, our success is heavily dependent on intellectual property, particularly patents
relating to our research programs and products. Obtaining and enforcing patents in the life sciences industry involves both
technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Changes in either the
patent laws or interpretation of the patent laws in the United States or the USPTO rules and regulations could increase these
uncertainties and costs. Patent reform legislation in the United States and other countries, including the Leahy-Smith America
Invents Act, or the AIA, signed into law on September 16, 2011, could increase those uncertainties and costs surrounding the
prosecution of our patent applications and the enforcement or defense of our issued patents. The AIA includes a number of
significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine
prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. These
include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack
the validity of a patent in USPTO administered post-grant proceedings, including post-grant review, inter partes review, and
derivation proceedings. For applications filed after March 15, 2013 that do not claim the benefit of applications filed before that
date, the AIA transitioned the United States from a first to invent system to a first-inventor-to-file system in which, assuming
that the other statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an
invention regardless of whether a third party was the first to invent the claimed invention. The AIA and its implementation
could increase the uncertainties and costs surrounding the prosecution of our patent applications, our ability to obtain future
patents, and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business,
financial condition, results of operations and prospects.
The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection
available in certain circumstances or weakening the rights of patent owners in certain situations.
Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other
countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to
obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
Our in-licensed intellectual property has been discovered through government funded programs and thus may be subject to
federal regulations such as ‘‘march-in’’ rights, certain reporting requirements and a preference for U.S.-based companies,
and compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S.
manufacturers.
Intellectual property rights that have been in-licensed pursuant to our license agreement, or the License Agreement, with
WUSTL have been generated through the use of U.S. government funding, and are therefore subject to certain federal
regulations. As a result, the United States federal government may retain certain rights to intellectual property embodied in our
current or future product candidates under the Bayh-Dole Act. These federal government rights include a ‘‘nonexclusive,
nontransferable, irrevocable, paid-up license’’ to use inventions for any governmental purpose. The Bayh-Dole Act also
provides federal agencies with ‘‘march-in rights.’’ March-in rights allow the government, in specified circumstances, to require
the contractor or successors in title to the patent to grant a ‘‘nonexclusive, partially exclusive, or exclusive license’’ to a
‘‘responsible applicant or applicants’’ if it determines that (1) adequate steps have not been taken to commercialize the
invention, (2) government action is necessary to meet public health or safety needs or (3) government action is necessary to
meet requirements for public use under federal regulations. If the patent owner refuses to do so, the government may grant the
license itself.
The U.S. government also has the right to take title to these inventions if the licensor fails to disclose the invention to the
government or fails to file an application to register the intellectual property within specified time limits. Intellectual property
generated under a government funded program is also subject to certain reporting requirements, compliance with which may
require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these
inventions or produced through the use of any of these inventions be manufactured substantially in the United States, and the
License Agreement requires that we comply with this requirement. This preference for U.S. industry may be waived by the
federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but
unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This
preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such
intellectual property. To the extent any of our owned or future in-licensed intellectual property is also generated through the use
of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.
56
Issued patents covering our products and related technologies could be found invalid or unenforceable if challenged.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability. Some of our patents or patent
applications (including licensed patents) have been, are being or may be challenged at a future point in time in an opposition,
nullification, derivation, reexamination, inter partes review, post-grant review or interference action in court or before patent
offices or similar proceedings for a given period after allowance or grant, during which time third parties can raise objections
against such grant. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may
be compelled to limit the scope of the allowed or granted claims thus attacked, or may lose the allowed or granted claims
altogether. Any successful third-party challenge to our patents in this or any other proceeding could result in the
unenforceability or invalidity of such patents, which may lead to increased competition to our business, which could harm our
business. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened,
regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current
or future diagnostic tests.
We may not be aware of all third-party intellectual property rights potentially relating to our products. Publications of
discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and
other jurisdictions are typically not published until approximately 18 months after filing or, in some cases (e.g., U.S.
applications for which a request not to publish has been filed), not until such patent applications issue as patents. We might not
have been the first to make the inventions covered by each of our pending patent applications and we might not have been the
first to file patent applications for these inventions. To determine the priority of these inventions, we have and may have to
participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO that
could result in substantial cost to us. The outcome of such proceedings is uncertain. We can give no assurance that all of the
potentially relevant art relating to our patents and patent applications has been found; overlooked prior art could be used by a
third party to challenge the validity, enforceability and scope of our patents or prevent a patent from issuing from a pending
patent application. As a result, we may not be able to obtain or maintain protection for certain inventions. No assurance can be
given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of
the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome
is therefore uncertain. Therefore, the validity, enforceability and scope of our patents in the United States and other countries
cannot be predicted with certainty and, as a result, any patents that we own or license may not provide sufficient protection
against our competitors. Furthermore, if third parties bring these proceedings against our patents, we could experience
significant costs and management distraction.
Our commercial success depends significantly on our ability to operate without infringing upon the intellectual property
rights of third parties.
The life sciences industry is subject to rapid technological change and substantial litigation regarding patent and other
intellectual property rights. Our potential competitors in both the United States and abroad, may have substantially greater
resources and are likely to make substantial investments in patent portfolios and competing technologies, and may apply for or
obtain patents that could prevent, limit or otherwise interfere with our ability to make, use and sell our products. Numerous
third-party patents exist in fields relating to our products and technologies, and it is difficult for industry participants, including
us, to identify all third-party patent rights relevant to our products and technologies. Moreover, because some patent
applications are maintained as confidential for a certain period of time, we cannot be certain that third parties have not filed
patent applications that cover our products and technologies.
Patents could be issued to third parties that we may ultimately be found to infringe. Third parties may have or obtain valid and
enforceable patents or proprietary rights that could block us from using our technology. Our failure to obtain or maintain a
license to any technology that we require may materially harm our business, financial condition and results of operations.
Furthermore, we would be exposed to a threat of litigation.
From time to time, we may be party to, or threatened with, litigation or other proceedings with third parties, including non-
practicing entities, who allege that our products, components of our products, and/or proprietary technologies infringe,
misappropriate or otherwise violate their intellectual property rights. The types of situations in which we may become a party to
such litigation or proceedings include:
•
•
we may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third
parties or to obtain a judgment that our products or technologies do not infringe those third parties’ patents;
we may participate at substantial cost in International Trade Commission proceedings to abate importation of products
that would compete unfairly with our products or technologies;
57
•
•
•
•
•
if a competitor files patent applications that claim technology also claimed by us or our licensors, we or our licensors
may be required to participate in interference, derivation or opposition proceedings to determine the priority of
invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent
position;
if third parties initiate litigation claiming that our products or technologies infringe their patent or other intellectual
property rights, we will need to defend against such proceedings;
if third parties initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to
obtain a declaratory judgment that their products, services, or technologies do not infringe our patents or patents
licensed to us, we will need to defend against such proceedings;
we may be subject to ownership disputes relating to intellectual property, including disputes arising from conflicting
obligations of consultants or others who are involved in developing our products and technologies; and
if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our products or
technologies infringe or misappropriate its patent or other intellectual property rights and/or that we breached our
obligations under the license agreement, and we would need to defend against such proceedings.
These lawsuits and proceedings, regardless of merit, are time-consuming and expensive to initiate, maintain, defend or settle,
and could divert the time and attention of managerial and technical personnel, which could materially adversely affect our
business. Any such claim could also force us to do one or more of the following:
•
•
•
•
•
•
•
•
incur substantial monetary liability for infringement or other violations of intellectual property rights, which we may
have to pay if a court decides that the diagnostic test or technology at issue infringes or violates the third party’s rights,
and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the third party’s
attorneys’ fees;
stop manufacturing, offering for sale, selling, using, importing, exporting or licensing the diagnostic test or technology
incorporating the allegedly infringing technology or stop incorporating the allegedly infringing technology into such
test or technology;
obtain from the owner of the infringed intellectual property right a license, which may require us to pay substantial
upfront fees or royalties to sell or use the relevant technology and which may not be available on commercially
reasonable terms, or at all;
redesign our products and technologies so they do not infringe or violate the third party’s intellectual property rights,
which may not be possible or may require substantial monetary expenditures and time;
enter into cross-licenses with applicable third party, which could weaken our overall intellectual property position;
lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection
and assertion of our intellectual property against others;
find alternative suppliers for non-infringing technologies, which could be costly and create significant delay; or
relinquish rights associated with one or more of our patent claims, if our claims are held invalid or otherwise
unenforceable.
Third parties may be able to sustain the costs of complex intellectual property litigation more effectively than we can because
they have substantially greater resources. In addition, intellectual property litigation, regardless of its outcome, may cause
negative publicity, adversely impact our business, cause delays, or prohibit us from marketing or otherwise commercializing
our products and technologies. Any uncertainties resulting from the initiation and continuation of any litigation could have a
material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business,
results of operation, financial condition or cash flows.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is
a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could
also be public announcements of the results of hearings, motions or other interim proceedings or developments, which could
have a material adverse effect on the price of our common stock. If securities analysts or investors perceive these results to be
negative, it could have a material adverse effect on the price of our common stock. The occurrence of any of these events may
have a material adverse effect on our business, results of operation, financial condition or cash flows.
58
We depend on information technology systems that we license from third parties. Any failure of such systems or loss of
licenses to the software that comprises an essential element of such systems could significantly harm our business.
We depend on information technology systems for significant elements of our operations, such as our laboratory information
management systems, including test validation, specimen tracking and quality control, our bioinformatics analytical software
systems, our test report generating systems and billing systems. Essential elements of these systems depend on software that we
license from third parties. If we are unable to maintain the licenses to this software or our software providers discontinue or
alter the programs on which we rely, it could render our test reports unreliable or hinder our ability to generate accurate test
reports, among other things. Any of the foregoing could have a material adverse effect on our competitive position, business,
financial conditions, results of operations and prospects.
We rely on licenses from third parties, and if we lose these licenses or are not able to obtain licenses to third-party
technology on reasonable grounds or at all, then we may not be able to continue to commercialize existing diagnostic tests,
be subjected to future litigation and may not be able to commercialize new diagnostic tests in the future.
We are party to certain royalty-bearing license agreements that grant us rights to use certain intellectual property, including
patents and patent applications, in certain specified fields of use. Although we intend to develop products and technologies
through our own internal research, we may need to obtain additional licenses from others to advance our research, development
and commercialization activities. Our license agreements impose, and we expect that future license agreements will impose,
various development, diligence, commercialization and other obligations on us.
In the future, we may identify third-party technology we may need, including to develop or commercialize new diagnostic tests
or services. In return for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our
solutions. Royalties are a component of the cost of our products or services and affect our margins. We may also need to
negotiate licenses to patents or patent applications before or after introducing a commercialized test. The in-licensing and
acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also
pursuing strategies to in-license or acquire third-party intellectual property rights for technologies that we may consider
attractive or necessary.
These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical
development and commercialization capabilities. Furthermore, companies that perceive us to be a competitor may be unwilling
to assign or license rights to us. In addition, we expect that competition for the in-licensing or acquisition of third-party
intellectual property rights for technologies that are attractive to us may increase in the future, which may mean fewer suitable
opportunities for us as well as higher acquisition or licensing costs. We may not be able to obtain necessary or strategic licenses
to patents or patent applications, and our business may suffer if we are unable to enter into these licenses on acceptable terms or
at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to
prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.
In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license
agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and
commercialize tests and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying
patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory
approval of, and to market, tests identical to ours and we may be required to cease our development and commercialization
activities. For example, we license certain intellectual property from WUSTL that is incorporated into DecisionDx-UM. In
2020, we provided nearly 1,400 test reports for DecisionDx-UM. If this license agreement were terminated, we would be unable
to continue to issue test reports and thus sales of DecisionDx-UM. Any of the foregoing could have a material adverse effect on
our competitive position, business, financial conditions, results of operations and prospects.
Moreover, disputes may arise with respect to any one of our licensing agreements, including:
•
•
•
•
•
•
the scope of rights granted under the license agreement and other interpretation-related issues;
the extent to which our products, technology and processes infringe on intellectual property of the licensor that is not
subject to the licensing agreement;
the sublicensing of patent and other rights under our collaborative development relationships;
our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual
property by our licensors and us and our partners; and
the priority of invention of patented technology.
59
If we do not prevail in such disputes, we may lose any of such license agreements.
In addition, the agreements under which we currently license intellectual property or technology from third parties are complex,
and certain provisions in such agreements may be susceptible to multiple interpretations.
The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our
rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations
under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results
of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability
to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop
and commercialize the affected diagnostic tests, which could have a material adverse effect on our business, financial
conditions, results of operations and prospects.
Our failure to maintain such licenses could have a material adverse effect on our business, financial condition and results of
operations. Any of these licenses could be terminated, such as if either party fails to abide by the terms of the license, or if the
licensor fails to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or
unenforceable. Absent the license agreements, we may infringe patents subject to those agreements, and if the license
agreements are terminated, we may be subject to litigation by the licensor. Litigation could result in substantial costs and be a
distraction to management. If we do not prevail, we may be required to pay damages, including treble damages, attorneys’ fees,
costs and expenses, royalties or, be enjoined from selling our products or services, including DecisionDx-UM and DecisionDx-
Melanoma, which could adversely affect our ability to offer our products or services, our ability to continue operations and our
financial condition.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on our products in all countries throughout the world would be prohibitively
expensive. The requirements for patentability may differ in certain countries, particularly developing countries, and the breadth
of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries do not protect intellectual property
rights to the same extent as the laws of the United States, and we may encounter difficulties in protecting and defending such
rights in foreign jurisdictions. Consequently, we may not be able to prevent third parties from practicing our inventions in all
countries outside the United States, or from selling or importing products made using our inventions in and into the United
States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent
protection to develop their own tests or products and may also export infringing tests or products to territories where we have
patent protection, but enforcement is not as strong as in the United States. These products may compete with our products. Our
patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign
jurisdictions. The legal systems of many other countries do not favor the enforcement of patents and other intellectual property
protection, particularly those relating to life science technologies, which could make it difficult for us to stop the infringement
of our patents in such countries. We do not have patent rights in certain foreign countries in which a market may exist.
Moreover, in foreign jurisdictions where we do have patent rights, proceedings to enforce our patent rights could result in
substantial cost and divert our efforts and attention from other aspects of our business, could put our patents at risk of being
invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert
claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may
not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be
inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. We may not
be able to stop a competitor from marketing and selling in foreign countries tests, products and services that are the same as or
similar to our products and technologies, in which case our competitive position in the international market would be harmed.
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely
affected and our business could be harmed.
In addition to pursuing patents on our technology, we also rely on trade secrets, including unpatented know-how, technology
and other proprietary information, to maintain our competitive position. We take steps to protect our trade secrets, in part, by
entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment
agreements, with our employees, consultants, academic institutions, corporate partners and, when needed, our advisers.
However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain
that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise
gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any
of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and, once
60
disclosed, we are likely to lose trade secret protection and may not be able to obtain adequate remedies for such breaches. Such
agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary
information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to
prevent such unauthorized disclosure. If we are required to assert our rights against such party, it could result in significant cost
and distraction.
Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure
are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets,
it would be expensive and time-consuming, and the outcome would be unpredictable. In addition, courts outside the United
States may be less willing to protect trade secrets.
We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical
security of our premises and physical and electronic security of our information technology systems, but it is possible that these
security measures could be breached. If any of our confidential proprietary information were to be lawfully obtained or
independently developed by a competitor, absent patent protection, we would have no right to prevent such competitor from
using that technology or information to compete with us, which could harm our competitive position.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed
confidential information of third parties.
We do and may employ individuals who previously worked with universities or other companies, including potential
competitors. We could in the future be subject to claims that we or our employees, consultants, or independent contractors have
inadvertently or otherwise used or disclosed alleged trade secrets or other confidential information of current or former
employers or competitors. Although we try to ensure that our employees, consultants and independent contractors do not use
the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may become
subject to claims that we caused an individual to breach the terms of his or her non-competition or non-solicitation agreement,
or that we or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary
information of a current or former employer or competitor. Although, we are currently not subject to any such claims.
While we may litigate to defend ourselves against these claims, even if we are successful, litigation could result in substantial
costs and could be a distraction to management and other employees. If our defenses to these claims fail, in addition to
requiring us to pay monetary damages, a court could prohibit us from using technologies or features that are essential to our
products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary
information of the current or former employers. Therefore, we could be required to obtain a license from such third-party
employer to commercialize our products or technology. Such a license may not be available on commercially reasonable terms
or at all.
Moreover, any such litigation or the threat thereof may adversely affect our reputation, our ability to form strategic alliances or
sublicense our rights to collaborators, engage with scientific advisors or hire employees or consultants, each of which would
have an adverse effect on our business, results of operations and financial condition.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our
markets of interest and our business may be adversely affected.
We have not yet registered certain of our trademarks in all of our potential markets, although we have registered, among others,
DecisionDx, DecisionDx-UM, DecisionDx-Melanoma and DecisionDx-SCC in the United States. Our current or future
registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or
descriptive determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade
names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in
our markets of interest. During trademark registration proceedings, we may receive rejections. Although we would be given an
opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in
comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark
applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our
trademarks, and our trademarks may not survive such proceedings. In addition, third parties have used trademarks similar and
identical to our trademarks in foreign jurisdictions, and have filed or may in the future file for registration of such trademarks. If
they succeed in registering or developing common law rights in such trademarks, and if we are not successful in challenging
such third-party rights, we may not be able to use these trademarks to market our products in those countries. If we are unable
to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our
business may be adversely affected. We may license our trademarks and trade names to third parties, such as distributors.
Although these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of
61
these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the
goodwill associated with our trademarks and trade names.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our
owned or in-licensed patents, trade secrets or other intellectual property as an inventor or co-inventor. For example, we or our
licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are
involved in developing our products. Litigation may be necessary to defend against these and other claims challenging
inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights, such as exclusive ownership of, right to use, or right to exclude others from using, intellectual
property that is important to our products. Even if we are successful in defending against such claims, litigation could result in
substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse
effect on our business, financial condition, results of operations and prospects.
In addition, while it is our policy to require our employees and contractors who may be involved in the development of
intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such
an agreement with each party who in fact develops intellectual property that we regard as our own. Our assignment agreements
may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they
may bring against us, to determine the ownership of what we regard as our intellectual property.
Obtaining and maintaining our patent protection depends on compliance with various required procedures, document
submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection
could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications must
be paid to the USPTO and various governmental patent agencies outside of the United States at several stages over the lifetime
of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm and
rely on our outside counsel to pay these fees due to non-U.S. patent agencies. The USPTO and various non-U.S. governmental
patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during
the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an
inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However,
there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in
partial or complete loss of patent rights in the relevant jurisdiction, such as failure to respond to official actions within
prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we, or our
licensors, fail to maintain the patents and patent applications covering our products and technologies, potential competitors may
be able to enter the market without infringing our patents and this circumstance would have a material adverse effect on our
business.
Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
Patents have a limited lifespan, and the protection patents afford is limited. In the United States, if all maintenance fees are
timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various
extensions may be available, but the term of a patent, and the protection it affords, is limited. Even if patents covering our
products are obtained, once the patent term has expired, we may be open to competition from competitive tests or products.
Given the amount of time required for the development, testing and regulatory review of potential new tests or products, patents
protecting such tests or products might expire before or shortly after such tests or products are commercialized. As a result, our
owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing tests or
other products similar or identical to ours.
Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business
We are highly dependent on the services of our key personnel.
We are highly dependent on the services of our key personnel, including Derek J. Maetzold, our President and Chief Executive
Officer. Although we have entered into agreements with them regarding their employment, they are not for a specific term and
each of may terminate their employment with us at any time, though we are not aware of any present intention of any of these
individuals to leave us.
Our research and development programs and laboratory operations depend on our ability to attract and retain highly skilled
scientists and technicians. We may not be able to attract or retain qualified scientists and technicians in the future due to the
62
competition for qualified personnel among life science businesses, particularly near our primary laboratory facility located in
Phoenix, Arizona. We also face competition from universities and public and private research institutions in recruiting and
retaining highly qualified scientific personnel. We may have difficulties locating, recruiting or retaining qualified salespeople.
Recruiting and retention difficulties can limit our ability to support our research and development and sales programs. All of
our employees are at-will, which means that either we or the employee may terminate their employment at any time.
Our employees, clinical investigators, consultants, speakers, vendors and any current or potential commercial partners may
engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
and insider trading.
We are exposed to the risk of fraud or other misconduct by our employees, clinical study investigators, consultants, speakers,
vendors and any potential commercial partners. Misconduct by these parties could include intentional, reckless and/or negligent
conduct or disclosure of unauthorized activities to us that violates: federal laws and regulations or those of comparable foreign
regulatory authorities, including those laws that require the reporting of true, complete and accurate information; manufacturing
standards; federal and state health and data privacy, security, fraud and abuse, government price reporting, transparency
reporting requirements, and other healthcare laws and regulations in the United States and abroad; sexual harassment and other
workplace misconduct; or laws that require the true, complete and accurate reporting of financial information or data. Such
misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in
regulatory sanctions and cause serious harm to our reputation. We have adopted a code of conduct applicable to all of our
employees, as well as a disclosure program and other applicable policies and procedures, but it is not always possible to identify
and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in
controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or
lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we
are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business,
including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual
imprisonment, exclusion from government funded healthcare programs, such as Medicare, Medicaid and other federal
healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity
reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect
our ability to operate our business and our results of operations.
We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
We have experienced significant revenue growth in a short period of time. We may not achieve similar growth rates in future
periods. You should not rely on our operating results for any prior periods as an indication of our future operating performance.
To effectively manage our anticipated future growth, we must continue to maintain and enhance our financial, accounting,
laboratory operations, customer support and sales administration systems, processes and controls. Failure to effectively manage
our anticipated growth could lead us to over-invest or under-invest in development, operational and administrative
infrastructure, result in weaknesses in our infrastructure, systems, or internal controls, give rise to operational mistakes, losses,
loss of customers, productivity or business opportunities, and result in loss of employees and reduced productivity of remaining
employees.
We also anticipate further growth in our business operations. This future growth could create strain on our organizational,
administrative and operational infrastructure, including laboratory operations, quality control, customer service and sales
organization management. We expect to increase headcount and to hire more specialized personnel in the future as we grow our
business. We will need to continue to hire, train and manage additional qualified scientists, laboratory personnel, client and
account services personnel, and sales and marketing staff and improve and maintain our technology to properly manage our
growth. If our new hires perform poorly, if we are unsuccessful in hiring, training, managing and integrating these new
employees or if we are not successful in retaining our existing employees, our business may be harmed.
In addition, our anticipated growth could require significant capital expenditures and might divert financial resources from other
projects such as the development of new diagnostic tests and services. As we commercialize additional diagnostic tests, we may
need to incorporate new equipment, implement new technology systems, or hire new personnel with different qualifications.
Failure to manage this growth or transition could result in turnaround time delays, higher costs, declining quality, deteriorating
customer service, and slower responses to competitive challenges. A failure in any one of these areas could make it difficult for
us to meet market expectations for our products, and could damage our reputation and the prospects for our business.
We may not be able to maintain the quality or expected turnaround times of our products, or satisfy customer demand as it
grows. Our ability to manage our growth properly will require us to continue to improve our operational, financial and
management controls, as well as our reporting systems and procedures. The time and resources required to implement these
new systems and procedures is uncertain, and failure to complete this in a timely and efficient manner could adversely affect
63
our operations. If our management is unable to effectively manage our anticipated growth, our expenses may increase more
than expected, our revenue could decline or grow more slowly than expected and we may be unable to implement our business
strategy. The quality of our products and services may suffer, which could negatively affect our reputation and harm our ability
to retain and attract customers.
We may engage in strategic transactions, such as the acquisition of businesses, assets, products or technologies, which could
be disruptive to our existing operations, divert the attention of our management team and adversely impact our liquidity,
cash flows, financial condition and results of operations.
From time to time, we may consider strategic opportunities and engage in transactions such as acquisitions of businesses,
assets, products or technologies, as well as technology licenses or investments in complementary businesses. Any such
transactions may entail numerous operational and financial risks, including:
•
•
•
•
•
•
delays, difficulties and higher than expected costs associated with integration activities, such as those involving
operational processes, regulatory and licensure compliance, personnel and information technology systems;
disruption of our existing business operations and diversion of management’s time, focus and attention;
decreases in our liquidity and operating cash flows, increases in our overall operating costs, substantial amounts of
amortization expense, increased capital expenditure requirements and non-recurring charges, including possible
impairments of acquired assets;
incurrence of substantial debt or dilutive issuances of equity securities, the assumption of additional liabilities and
exposure to unknown liabilities;
inability to retain key personnel of any acquired businesses; and
failure to realize all or any of the anticipated revenues, synergies, efficiencies or other benefits of a transaction within
our estimated time frame or at all.
We are unable to predict the timing, size or nature of any future transactions, whether they will be completed or financed on
favorable terms, if at all, or what the impact of those transactions might be on our financial results, including if such
transactions are not effectively and profitably integrated into our business. Our failure to successfully complete the integration
of any business that we acquire could have an adverse effect on our prospects, business activities, cash flows, financial
condition, results of operations and stock price. Additionally, since we have not historically completed any such transactions to
date, our ability to successfully integrate, manage and derive benefits from any acquired business, asset, product or technology
is unproven.
Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income may be
subject to limitations.
At December 31, 2020, we had federal net operating loss, NOL, carryforwards of approximately $55.9 million, of which $42.0
million will begin to expire in 2033 if not utilized to offset taxable income, and $13.9 million may be carried forward
indefinitely.
Under the TCJA, as modified by the CARES Act, federal NOL carryforwards generated in taxable years beginning after
December 31, 2017 may be carried forward indefinitely, but the deductibility of such NOL carryforwards in taxable years
beginning after December 31, 2020 is limited to 80% of taxable income. It is uncertain if and to what extent various states will
conform to the TCJA or the CARES Act.
In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of
state law, if a corporation undergoes an ‘‘ownership change’’ (which is generally defined as a greater than 50% change (by
value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change NOL carryforwards and
other pre-change tax attributes to offset its post-change income or taxes may be limited. We have experienced an ownership
change in the past and we may also experience additional ownership changes in the future as a result of subsequent shifts in our
stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our NOL
carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax
obligations. In addition, at the state level, there may be periods during which the use of NOL carryforwards is suspended or
otherwise limited, which could accelerate or permanently increase state taxes owed.
Our business could be negatively impacted by cyber security threats.
We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the
ordinary course of business, we collect, store and transmit confidential information (including but not limited to intellectual
property, proprietary business information and personal information). It is critical that we do so in a secure manner to maintain
64
the confidentiality and integrity of such confidential information. We also have outsourced elements of our operations to third
parties, and as a result we manage a number of third-party contractors who have access to our confidential information.
Despite the implementation of security measures, given their size and complexity and the increasing amounts of confidential
information that they maintain, our internal information technology systems and those of our contractors and consultants are
potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural
disasters, terrorism, war, public health crises and telecommunication and electrical failures, as well as security breaches from
inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or
from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service
attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability
of information), which may compromise our system infrastructure or lead to data leakage. To the extent that any disruption or
security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or
proprietary information, we could incur liability and reputational damage and the further development and commercialization of
our products could be delayed.
While we have not experienced any such system failure, accident or material security breach to date, we cannot assure you that
our data protection efforts and our investment in information technology will prevent significant breakdowns, data leakages,
breaches in our systems or other cyber incidents that could have a material adverse effect upon our reputation, business,
operations or financial condition. For example, we maintain a tumor specimen database comprised of over 60,000 samples
some of which were used to develop and validate DecisionDx-Melanoma, some of which are currently being used to improve
on the test and some of which will be used in the future. If we were to lose this database, our ability to further validate, improve
and therefore maintain and grow sales of DecisionDx-Melanoma could be significant impaired.
Furthermore, significant disruptions of our internal information technology systems or security breaches could result in the loss,
misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to, confidential information
(including trade secrets or other intellectual property, proprietary business information, and personal information), which could
result in financial, legal, business, and reputational harm to us. For example, any such event that leads to unauthorized access,
use, or disclosure of personal information, including personal information related to our patient samples or employees, could
harm our reputation directly, compel us to comply with federal and/or state breach notification laws and foreign law
equivalents, subject us to mandatory corrective action, and otherwise subject us to liability under laws and regulations that
protect the privacy and security of personal information, which could result in significant legal and financial exposure and
reputational damages that could potentially have an adverse effect on our business.
Product or professional liability lawsuits against us could cause us to incur substantial liabilities and could limit our
commercialization of our products.
We face an inherent risk of product and professional liability exposure related to our products. The marketing, sale and use of
our products could lead to the filing of product liability claims were someone to allege that our products identified or reported
inaccurate or incomplete information, or otherwise failed to perform as designed. We may also be subject to liability for errors
in, a misunderstanding of or inappropriate reliance upon, the information we provide in the ordinary course of our business
activities.
If we cannot successfully defend ourselves against claims that our products caused injury or otherwise failed to function
properly, we could incur substantial liabilities. Regardless of merit or eventual outcome, product liability claims may result in:
•
•
•
•
•
•
•
•
decreased demand for our current tests any tests that we may develop, and the inability to commercialize such tests;
injury to our reputation and significant negative media attention;
reluctance of experts willing to conduct our clinical studies;
initiation of investigations by regulators;
significant costs to defend the related litigation and diversion of management’s time and our resources;
substantial monetary awards to study subjects or patients;
product recalls, withdrawals or labeling, or marketing or promotional restrictions; and
loss of revenue.
We currently carry product liability insurance. However, the amount of this insurance may not be adequate to cover all
liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage
at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
65
International expansion of our business exposes us to business, regulatory, political, operational, financial, and economic
risks associated with doing business outside of the United States.
While we currently accept orders from customers outside of the United States, our historical business strategy has been directed
toward customers within the United States. Our long-term business strategy contemplates potential international expansion.
Doing business internationally involves a number of risks, including:
• multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import
restrictions, economic sanctions and embargoes, employment laws, regulatory requirements and other governmental
approvals, permits and licenses;
•
•
•
•
•
•
•
•
•
limits in our ability to penetrate international markets if we are not able to perform tests locally;
logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation
delays;
difficulties in staffing and managing foreign operations;
failure to obtain regulatory approvals for the commercialization of our products in various countries;
complexities and difficulties in obtaining intellectual property protection and enforcing our intellectual property;
complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay
systems;
financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and
regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate
fluctuations;
natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease,
boycotts, curtailment of trade and other business restrictions; and
regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’
activities that may fall within the purview of the FCPA, its books and records provisions, or its anti-bribery provisions.
Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue
and results of operations.
Requirements associated with being a public company will increase our costs significantly, as well as divert significant
company resources and management attention.
We are subject to the reporting requirements of the Exchange Act or the other rules and regulations of the SEC and any
securities exchange relating to public companies. Sarbanes-Oxley, as well as rules subsequently adopted by the SEC and The
Nasdaq Stock Market LLC, or Nasdaq, to implement provisions of Sarbanes-Oxley, impose significant requirements on public
companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in
corporate governance practices. Further, pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010,
the SEC has adopted additional rules and regulations in these areas, such as mandatory ‘‘say on pay’’ voting requirements that
will apply to us when we cease to be an emerging growth company. Stockholder activism, the current political environment and
the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure
obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways
we cannot currently anticipate. Compliance with the various reporting and other requirements applicable to public companies
requires considerable time and attention of management. We cannot assure you that we will satisfy our obligations as a public
company on a timely basis.
We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance
costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our
management and personnel from other business concerns, they could have a material adverse effect on our business, financial
condition and results of operations. The increased costs will increase our net loss or decrease our net income, and may require
us to reduce costs in other areas of our business or increase the prices of our products. In addition, as a public company, it may
be more difficult or more costly for us to obtain certain types of insurance, including directors’ and officers’ liability insurance,
and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or
similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified personnel to
serve on our board of directors, our board committees or as executive officers.
66
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or
penalties or incur costs that could have a material adverse effect on the success of our business.
We, and the third parties with whom we share our facilities, are subject to numerous environmental, health and safety laws and
regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of
hazardous materials and wastes. Each of our operations involve the use of hazardous and flammable materials, including
chemicals and biological and radioactive materials. Our operations also produce hazardous waste. We generally contract with
third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these
materials. We could be held liable for any resulting damages in the event of contamination or injury resulting from the use of
hazardous materials by us or the third parties with whom we share our facilities, and any liability could exceed our resources.
We also could incur significant costs associated with civil or criminal fines and penalties.
Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our
employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential
liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in
connection with our storage or disposal of biological, hazardous or radioactive materials.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and
regulations. These current or future laws and regulations may impair our research and development. Failure to comply with
these laws and regulations also may result in substantial fines, penalties or other sanctions.
Our business could be adversely affected by natural disasters, public health epidemics and other events beyond our control.
Although we maintain crisis management plans, our business operations are subject to interruption by natural disasters and
other events and catastrophes beyond our control, including, but not limited to, earthquakes, floods, fires, tornadoes, hurricanes,
power or other utility outages, telecommunications failures and public health crises. Further, outbreaks of epidemic diseases,
such as the COVID-19 pandemic discussed above, or the fear of such events, could provoke responses, including government-
imposed travel restrictions that could impede the mobility and effectiveness of our sales force, disrupt our operations or those of
our suppliers and service providers. The ultimate impact of any of these or similar events is highly uncertain and could have a
material adverse impact on our operations.
Risks Related to Ownership of Our Common Stock
The stock price of our common stock may be volatile or may decline regardless of our operating performance, and you may
lose all or part of your investment.
The market price of our common stock may fluctuate significantly in response to numerous factors, many of which are beyond
our control, including:
•
•
•
•
•
•
•
•
•
•
•
•
•
our operating performance and the performance of other similar companies;
our success in marketing and selling our products;
reimbursement determinations by third-party payors and reimbursement rates for our products;
changes in our projected operating results that we provide to the public, our failure to meet these projections or
changes in recommendations by securities analysts that elect to follow our common stock;
regulatory or legal developments in the United States and other countries;
the level of expenses related to product development and clinical studies for our products;
our ability to achieve product development goals in the timeframe we announce;
announcements of clinical study results, regulatory developments, acquisitions, strategic alliances or significant
agreements by us or by our competitors;
the success or failure of our efforts to acquire, license or develop additional tests;
recruitment or departure of key personnel;
the economy as a whole and market conditions in our industry;
the extent and duration of the impacts from the COVID-19 pandemic;
trading activity by a limited number of stockholders who together beneficially own a significant percentage of our
outstanding common stock;
67
•
•
the size of our market float; and
any other factors discussed in this Annual Report on Form 10-K.
In addition, the stock market in general, and diagnostic and life sciences companies in particular, have experienced extreme
price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these
companies. Broad market and industry factors may negatively affect the market price of our securities, regardless of our actual
operating performance. In the past, stockholders have filed securities class action litigation following periods of market
volatility. If we were to become involved in securities litigation, it could subject us to substantial costs, divert resources and the
attention of management from our business and adversely affect our business.
If there are substantial sales of shares of our common stock, the price of our common stock could decline.
The price of our common stock could decline if there are substantial sales of our common stock, particularly sales by our
directors, executive officers and significant stockholders, or if there is a large number of shares of our common stock available
for sale and the market perceives that sales will occur. Shares held by directors, executive officers and other affiliates are
subject to volume limitations under Rule 144 under the Securities Act of 1933, as amended, or the Securities Act.
Certain of our stockholders have rights, subject to some conditions, to require us to file registration statements covering their
shares or to include their shares in registration statements that we may file for ourselves or our stockholders. We have registered
shares of common stock that we have issued and may issue under our employee equity incentive plans. As a result, these shares
will be able to be sold freely in the public market upon issuance.
The market price of the shares of our common stock could decline as a result of the sale of a substantial number of our shares of
common stock in the public market or the perception in the market that the holders of a large number of shares intend to sell
their shares.
We have broad discretion in the use of working capital and may not use it effectively or in ways that increase our share
price.
We cannot specify with any certainty the particular uses of working capital, but we currently expect such uses will include:
funding selling and marketing activities, including expansion of our sales force to support the ongoing commercialization of
current and future products; research and development related to the continued support of our current products as well as the
development of our product pipeline; and other general corporate purposes, including the additional costs associated with being
a public company. The failure by our management to apply our working capital effectively could adversely affect our business
and financial condition. Pending its use, we may invest working capital in a manner that does not produce income or that loses
value. These investments may not yield a favorable return to our investors.
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. 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. If one or more of these analysts cease
coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our
common stock price and trading volume to decline.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
We are subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures
to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and
communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules
and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter
how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system
are met.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur
because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new
relationship or arrangement causing us to fail to make any related party transaction disclosures. Additionally, controls can be
circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the
controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur
and not be detected. In addition, we do not have a risk management program or processes or procedures for identifying and
addressing risks to our business in other areas.
68
We are an emerging growth company and a smaller reporting company and we cannot be certain if the reduced reporting
requirements applicable to emerging growth companies will make our common stock less attractive to investors.
We are an emerging growth company as defined in the JOBS ACT, and we intend to take advantage of some of the exemptions
from reporting requirements that are applicable to other public companies that are not emerging growth companies, including:
•
•
•
•
•
being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim
financial statements, with correspondingly reduced ‘‘Management’s Discussion and Analysis of Financial Condition
and Results of Operations’’ disclosure;
not being required to comply with the auditor attestation requirements in the assessment of our internal control over
financial reporting;
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight
Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information
about the audit and the financial statements;
reduced disclosure obligations regarding executive compensation; and
not being required to hold a non-binding advisory vote on executive compensation or obtain stockholder approval of
any golden parachute payments not previously approved.
In addition, as an emerging growth company the JOBS Act allows us to delay adoption of new or revised accounting
pronouncements applicable to public companies until such pronouncements are made applicable to private companies. We have
elected to use this extended transition period under the JOBS Act. We may take advantage of these reporting exemptions until
we are no longer an emerging growth company. We will remain an emerging growth company until the earlier of (1) December
31, 2024, (2) the last day of the fiscal year (a) in which we have total annual gross revenue of at least $1.07 billion or (b) in
which we are deemed to be a ‘‘large accelerated filer’’ as defined in Rule 12b-2 under the Exchange Act, which means the
market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (3) the date
on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We are also a smaller reporting company as defined in the Exchange Act. We may continue to be a smaller reporting company
even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available
to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of
our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of
our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and
the market value of our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the
last business day of our second fiscal quarter.
We cannot predict if investors will find our common stock less attractive because we will rely on these exemptions. If some
investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and
our stock price may be more volatile.
As of March 5, 2021, the market value of our common stock held by non-affiliates exceeded $700.0 million. If the market value
of our common stock held by non-affiliates exceeds $700.0 million as of June 30, 2021, we will cease to be an emerging growth
company effective December 31, 2021. Additionally, in such case, we expect to no longer qualify as a smaller reporting
company beginning with our first Quarterly Report on Form 10-Q for the fiscal year ending December 31, 2022.
We do not intend to pay dividends for the foreseeable future.
We have never declared nor paid cash dividends on our capital stock. We currently intend to retain any future earnings to
finance the operation and expansion of our business, and we do not expect to declare or pay any dividends in the foreseeable
future. Consequently, stockholders must rely on sales of their common stock after price appreciation, which may never occur,
as the only way to realize any future gains on their investment.
69
The concentration of our stock ownership will likely limit your ability to influence corporate matters, including the ability to
influence the outcome of director elections and other matters requiring stockholder approval.
Based upon shares outstanding as of December 31, 2020, our executive officers, directors and the known holders of more than
5% of our outstanding common stock, in the aggregate, beneficially owned approximately 33% of our common stock. As a
result, these stockholders, acting together, will have significant influence over all matters that require approval by our
stockholders, including the election of directors and approval of significant corporate transactions. Corporate actions might be
taken even if other stockholders oppose them. This concentration of ownership might also have the effect of delaying or
preventing a change of control of our company that other stockholders may view as beneficial.
Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws
could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may delay or discourage
transactions involving an actual or potential change in our control or change in our management, including transactions in
which stockholders might otherwise receive a premium for their shares or transactions that our stockholders might otherwise
deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among
other things, our amended and restated certificate of incorporation and amended and restated bylaws:
•
•
•
•
•
•
•
•
•
•
permit our board of directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and
privileges as they may designate (including the right to approve an acquisition or other change in our control);
provide that the authorized number of directors may be changed only by resolution of the board of directors;
provide that the board of directors or any individual director may only be removed with cause and the affirmative vote
of the holders of at least 66-2/3% of the voting power of all of our then outstanding common stock;
provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled
by the affirmative vote of a majority of directors then in office, even if less than a quorum;
divide our board of directors into three classes;
require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of
stockholders and not be taken by written consent;
provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for
election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify
requirements as to the form and content of a stockholder’s notice;
do not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common
stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so
choose);
provide that special meetings of our stockholders may be called only by the chairman of the board, our Chief
Executive Officer or by the board of directors pursuant to a resolution adopted by a majority of the total number of
authorized directors;
provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of
Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state
court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the
federal district court for the District of Delaware) will be the sole and exclusive forum for the following types of
actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on
our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or
former directors, officers or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim
against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any
provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; (iv) any action or
proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; (v)
any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of
Chancery of the State of Delaware; and (vi) any action asserting a claim against us or any of our directors, officers or
other employees governed by the internal affairs doctrine, in all cases to the fullest extent permitted by law and subject
to the court’s having personal jurisdiction over the indispensable parties named as defendants; provided these
provisions of our amended and restated certificate of incorporation and amended and restated bylaws will not apply to
70
suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the federal courts
have exclusive jurisdiction; and
•
provide that unless we consent in writing to the selection of an alternative forum, the federal district courts of the
United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action
arising under the Securities Act, subject to and contingent upon a final adjudication in the State of Delaware of the
enforceability of such exclusive forum provision.
The amendment of any of these provisions, with the exception of the ability of our board of directors to issue shares of
preferred stock and designate any rights, preferences and privileges thereto, would require approval by the holders of at least
66-2/3% of our then-outstanding common stock.
In addition, as a Delaware corporation, we are subject to Section 203 of the Delaware General Corporation Law. These
provisions may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from
merging or combining with us for a certain period of time. A Delaware corporation may opt out of this provision by express
provision in its original certificate of incorporation or by amendment to its certificate of incorporation or bylaws approved by
its stockholders. However, we have not opted out of this provision.
These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware
law could make it more difficult for stockholders or potential acquirors to obtain control of our board of directors or initiate
actions that are opposed by our then-current board of directors, including delay or impede a merger, tender offer or proxy
contest involving our company. The existence of these provisions could negatively affect the price of our common stock and
limit opportunities for you to realize value in a corporate transaction.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the
exclusive forum for certain 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, unless we consent in writing to the selection of an
alternative forum, the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of
Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state
courts lack subject matter jurisdiction, the federal district court for the District of Delaware) will be the sole and exclusive
forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or
proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of
our current or former directors, officers or other employees to us or our stockholders; (iii) any action or proceeding asserting a
claim against us or any of our current or former directors, officers or other employees arising out of or pursuant to any
provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or amended and
restated bylaws; (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our amended and restated
certificate of incorporation or our amended and restated bylaws; (v) any action or proceeding as to which the Delaware General
Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and (vi) any action asserting a claim
against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine, in all cases to the
fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as
defendants; provided these provisions would not apply to suits brought to enforce a duty or liability created by the Exchange
Act, or any other claim for which the federal courts have exclusive jurisdiction. This provision would not apply to suits brought
to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent
jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have
jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent
or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation and
amended and restated bylaws provide that unless we consent in writing to the selection of an alternative forum, the federal
district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause
of action arising under the Securities Act, subject to and contingent upon a final adjudication in the State of Delaware of the
enforceability of such exclusive forum provision. While the Delaware courts have determined that such choice of forum
provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the
exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the
exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional
costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be
enforced by a court in those other jurisdictions.
These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for
disputes with us or our directors, officers or other employees and may discourage these types of lawsuits. Furthermore, the
71
enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in
legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. If a
court were to find the choice of forum provisions contained in our amended and restated certificate of incorporation to be
inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other
jurisdictions.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
We have a lease agreement for approximately 23,700 square feet of office space in Friendswood, Texas that will be used as our
corporate headquarters. This lease commenced on December 1, 2020 and has a 60-month term, with an option to renew for one
additional five-year period. Additionally, we lease approximately 7,100 square feet of other office space in Friendswood, Texas
under an agreement that is on a month-to-month basis. We also lease approximately 27,100 square feet of laboratory and office
space in Phoenix, Arizona under two agreements, one of which expires on July 31, 2027 and the other expires on March 31,
2028. Each of these leases provide us with two optional renewal periods of five years each. We believe our existing facilities
will be sufficient for our needs for the foreseeable future.
Item 3. Legal Proceedings.
From time to time, we may be involved in legal proceedings arising in the ordinary course of business. We believe there is no
threatened litigation or litigation pending that could have, individually or in the aggregate, a material adverse effect on our
financial position, results of operations or cash flows.
Item 4. Mine Safety Disclosures.
Not applicable.
72
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities.
Market Information
Our Common Stock, $0.001 par value per share, began trading on the Nasdaq Global Market under the symbol “CSTL” on July
25, 2019. Prior to that date, there was no public trading market for our common stock.
Holders of Record
As of March 5, 2021, there were approximately 108 stockholders of record of our common stock, which does not include shares
held in street name.
Dividend Policy
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and any
future earnings for use in the operation of our business and do not anticipate paying any dividends on our common stock in the
foreseeable future. Any future determination to declare dividends will be made at the discretion of our board of directors and
will depend on, among other factors, our financial condition, operating results, capital requirements, contractual restrictions,
general business conditions and other factors that our board of directors may deem relevant.
Securities Authorized for Issuance Under Our Equity Compensation Plans
Information regarding securities authorized for issuance under our equity compensation plans is incorporated herein by
reference to Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” of
Part III of this Annual Report on Form 10-K.
Performance Graph
Not required for smaller reporting companies.
Recent Sales of Unregistered Equity Securities
On December 11, 2020, we issued 209,238 shares of our common stock to SH Castle Biosciences, LLC upon the net exercise of
a warrant to purchase 209,243 shares of common stock at an exercise price of approximately $0.001 per share. Additionally, we
paid $41 in cash to SH Castle Biosciences, LLC for the value of a fractional share of common stock computed in connection
with such net exercise. The net exercise was based on a fair market value of our common stock of $59.16 per share and did not
result in any cash proceeds to us.
On December 29, 2020, we issued an aggregate of 31,814 shares of our common stock to OTA LLC upon the net exercise of
certain warrants to purchase an aggregate of 35,237 shares of common stock at an exercise price of approximately $7.10 per
share. The warrants were originally issued to Oxford Finance LLC on March 31, 2017 and November 30, 2018, but were later
transferred to OTA LLC in August 2020. We paid an aggregate of $58 in cash to OTA LLC for the value of fractional shares
computed in connection with such net exercises. In accordance with the terms of the warrants, the net exercises were based on
the fair market value of our common stock on the business day immediately prior to the date of delivery of the exercise notices,
in each case $73.05 per share, and did not result in any cash proceeds to us.
The issuances of these shares of common stock were deemed to be exempt from registration under the Securities Act in reliance
on Section 4(a)(2) (or Regulation D promulgated thereunder) in that the issuance of securities was to an accredited investor and
did not involve a public offering. The recipient of securities in each of these transactions acquired the securities for investment
only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the
securities issued in these transactions. The recipient of the securities in these transactions was an accredited investor under Rule
501 of Regulation D.
73
Use of Proceeds from IPO of Common Stock
On July 29, 2019, we completed the initial public offering of our common stock, or the IPO, pursuant to which we issued and
sold 4,600,000 shares of our common stock, including 600,000 shares associated with the full exercise of the underwriters’
option to purchase additional shares, at a price to the public of $16.00 per share.
The offer and sale of all of the shares of our common stock in the IPO were registered under the Securities Act pursuant to our
Registration Statements on Form S-1, as amended (File Nos. 333-232369 and 333-232796), which were declared or became
effective on July 24, 2019. SVB Leerink LLC and Robert W. Baird & Co. Incorporated acted as joint book-running managers
for the IPO and as representatives of the underwriters. Canaccord Genuity LLC and BTIG, LLC acted as co-managers for the
IPO.
We received gross proceeds from the IPO of $73.6 million, or net proceeds of $65.9 million after deducting $5.2 million in
underwriting discounts and commissions and $2.5 million of offering expenses. None of the underwriting discounts and
commissions or offering expenses were incurred or paid, directly or indirectly, to any of our directors or officers or their
associates or to persons owning 10% or more of our common stock or to any of our affiliates.
There has been no material change in our planned use of the net proceeds from the IPO as described in the final prospectus filed
with the SEC on July 26, 2019 relating to our Registration Statements on Form S-1 (File Nos. 333-232369 and 333-232796).
Since the effective date of our registration statement through December 31, 2020, we have not used any of the net proceeds
from the IPO. Pending such uses, we have invested, and plan to continue to invest, the balance of the net proceeds from the IPO
in cash and cash equivalent securities or highly liquid investment securities.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
Item 6. Selected Financial Data.
Not required for smaller reporting companies.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of financial condition and results of operations together with our
financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion and other parts
of this Annual Report on Form 10-K contain forward-looking statements that involve risk and uncertainties, such as statements
of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these
forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those
discussed in the section titled “Risk Factors.”
Overview
We are a commercial-stage dermatological cancer company focused on providing physicians and their patients with
personalized, clinically actionable genomic information to make more accurate treatment decisions. We believe that the
traditional approach to developing a treatment plan for certain cancers using clinical and pathology factors alone is inadequate
and can be improved by incorporating personalized genomic information. Our non-invasive products utilize proprietary
algorithms to provide an assessment of a patient’s specific risk of metastasis or recurrence of their cancer, allowing physicians
to identify patients who are likely to benefit from an escalation of care as well as those who may avoid unnecessary medical and
surgical interventions. Our lead product, DecisionDx®-Melanoma, is a proprietary GEP test that predicts the risk of metastasis
or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer. This test has two current
clinically actionable uses. The first use immediately following diagnosis predicts a patient’s likelihood of having a sentinel
lymph node negative biopsy result so that physicians and patients can discuss the risk and benefit of undergoing SLNB surgery.
The second use is to inform the appropriate treatment plan, regardless of the decision to undergo or avoid the SLNB surgery.
We estimate more than 130,000 patients are diagnosed with invasive cutaneous melanoma each year in the United States. We
launched DecisionDx-Melanoma in May 2013.
On August 31, 2020, we commercially launched our cutaneous squamous cell carcinoma proprietary GEP test,
DecisionDx®‑SCC, and on November 2, 2020, we commercially launched our proprietary GEP test for suspicious pigmented
lesions, DecisionDx® DiffDx™-Melanoma. These two indications are areas of high clinical need in dermatological cancer and,
together, represent an addressable population of approximately 500,000 patients in the United States.
74
We also market DecisionDx®-UM, which is a proprietary GEP test that predicts the risk of metastasis for patients with uveal
melanoma, a rare eye cancer. We launched DecisionDx-UM in January 2010.
Based on the substantial clinical evidence that we have developed, we have received Medicare coverage for DecisionDx-
Melanoma and DecisionDx-UM, which represents approximately 50% of the addressable patient population for both of these
tests.
We have processed over 70,000 clinical samples since our inception. Our revenue for the year ended December 31, 2020 was
$62.6 million, compared to $51.9 million for 2019 and $22.8 million for 2018.
The numbers of DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx-DiffDx and DecisionDx-UM test reports delivered by
us during the years ended December 31, 2020 and 2019 are presented in the table below:
Proprietary Dermatologic GEP Tests
DecisionDx-
Melanoma
DecisionDx-
SCC(1)
DecisionDx
DiffDx-
Melanoma(2)
DecisionDx-
UM
Total
Q1 2020
Q2 2020
Q3 2020
Q4 2020
For the year ended December 31, 2020
Q1 2019
Q2 2019
Q3 2019
Q4 2019
For the year ended December 31, 2019
4,574
3,008
4,404
4,246
16,232
3,232
3,691
4,126
4,480
15,529
—
—
57
428
485
—
—
—
—
—
(1) We commercially launched the DecisionDx-SCC test on August 31, 2020.
(2) We commercially launched the DecisionDx DiffDx on November 2, 2020.
—
—
—
73
73
—
—
—
—
—
361
306
318
410
4,935
3,314
4,779
5,157
1,395
18,185
360
376
356
434
3,592
4,067
4,482
4,914
1,526
17,055
While we continue to see new clinicians order the DecisionDx-Melanoma test for the first time, for the twelve months ended
December 31, 2020, the number of new ordering clinicians (first time ordering the test) for our DecisionDx-Melanoma test
decreased by 14% as compared to the same period in 2019. We believe these decreases in the number of new ordering
clinicians are the result of physician office closures and limited physician access due to the COVID-19 pandemic, as discussed
further below. Our commercial team is using a combination of in-person and virtual promotional efforts.
For additional information on the metrics we disclose, refer to “Information about certain metrics” below.
Since our inception in 2008, we have devoted substantially all of our resources to organizing and staffing our company,
business planning, raising capital, discovering product candidates, conducting clinical study activities to generate evidence
demonstrating the clinical validity, clinical utility, economic benefits, and patient outcomes of our products, and
commercialization activities for those products. We currently market four proprietary GEP products and generate substantially
all of our revenue from DecisionDx-Melanoma and DecisionDx-UM.
The principal focus of our current commercial efforts is to distribute our molecular diagnostic testing products through our
direct sales force in the U.S. The number of test reports we generate is a key indicator that we use to assess our business. A test
report is generated when we receive a sample in our laboratory, the relevant information relating to that test is entered into our
Laboratory Information Management System, the genomic profile of the sample is performed and a report providing the results
of that profile is sent to the physician who ordered the test.
We bill third-party payors and patients for the tests we perform. The majority of our revenue collections is paid by third-party
insurers, including Medicare. We have received LCDs, which provide coverage for our DecisionDx-Melanoma and
DecisionDx-UM tests that meet certain criteria for Medicare and Medicare Advantage beneficiaries, representing approximately
60 million covered lives. As it relates to DecisionDx-UM, we have contracts or have received positive medical policy decisions
from additional payors representing approximately 83 million covered lives. A ‘‘covered life’’ means a subscriber, or a
dependent of a subscriber, who is insured under an insurance policy for such an insurance carrier.
75
Palmetto GBA MolDX, or Palmetto, the MAC responsible for administering MolDX, the program that assesses molecular
diagnostic technologies, issued a final expanded LCD for DecisionDx-Melanoma, effective November 22, 2020. With this
expanded LCD and the accompanying billing and coding articles, we estimate that a significant majority of the DecisionDx-
Melanoma tests performed for Medicare patients will meet the coverage criteria. Noridian Healthcare Solutions, LLC, or
Noridian, the MAC responsible for administering claims for laboratory services performed in Arizona, has adopted the same
coverage policy as Palmetto and also issued an expanded final LCD for DecisionDx-Melanoma, effective December 6, 2020.
On May 17, 2019, CMS determined that DecisionDx-UM meets the criteria for “existing ADLT” status. Accordingly, in 2021
the DecisionDx-UM Medicare rate will be set annually based upon the median private payor rate for the first half of the second
preceding calendar year. Note that our rate for 2020 was set by Noridian, our local MAC, but our rate for 2021 for DecisionDx-
UM will be $7,776 based on the median private payor rate. Also, on May 17, 2019, CMS determined that DecisionDx-
Melanoma meets the criteria for ‘‘new ADLT’’ status. Accordingly, from July 1, 2019 through March 31, 2020 the Medicare
reimbursement rate was equal to the initial list price of $7,193. From April 1, 2020 through December 31, 2021, CMS notified
us that the rate will also be $7,193, which was calculated based upon the median private payor rate for DecisionDx-Melanoma
from July 1, 2019 to November 30, 2019. Beginning in 2022, the rate for both DecisionDx-Melanoma and DecisionDx-UM will
be set annually based upon the median private payor rate for the first half of the second preceding calendar year. For example,
the rate for 2022 will be set using median private payor rate data from January 1, 2020 to June 30, 2020.
In the second quarter of 2020, we submitted our technical assessment dossier for DecisionDx-SCC to Palmetto and Noridian. In
early 2021, we submitted our technical assessment dossier for DecisionDx DiffDx-Melanoma. We expect that draft LCDs for
each of these tests will be posted in 2021. However, there is no assurance that the timing of any draft LCD or final LCD will
match our expectations or our historical experience with LCDs for our other tests.
To date, in addition to the revenue generated from the sale of our products, we have financed our operations through our July
2019 IPO, follow-on public offerings of common stock in June 2020 and December 2020, private placements of preferred
stock, convertible promissory notes and bank debt. We believe that our existing cash and cash equivalents and anticipated cash
generated from sales of our products will be sufficient to fund our operations for the foreseeable future. However, we have
based these estimates on assumptions, including those related to the impact of COVID-19 on our financial condition, that may
prove to be wrong, and we could utilize our available capital resources sooner than we expect.
Our net (loss) income may fluctuate significantly from period to period, depending on the timing of our planned development
activities, the growth of our sales and marketing activities and the timing of revenue recognition under ASC 606. We expect our
expenses will increase substantially over time as we:
•
•
•
•
•
•
execute clinical studies to generate evidence supporting our current and future product candidates;
execute our commercialization strategy for our current and future products;
continue our ongoing and planned development of new products;
seek to discover and develop additional product candidates;
hire additional scientific and research and development staff; and
add additional operational, financial and management information systems and personnel.
Furthermore, we expect to continue to incur additional costs associated with operating as a public company, including
significant legal, accounting, investor relations and other expenses.
Impact of COVID-19 Pandemic
We are continuing to closely monitor the impact of the COVID-19 pandemic on our business and are taking proactive efforts
designed to protect the health and safety of our workforce, continue our business operations and advance our corporate
objectives. We are providing the following update with respect to the impact of COVID-19 on our business:
• We have maintained and expect to continue to maintain uninterrupted business operations, with adequate access to
reagents and consumables needed for testing patient samples and normal turnaround times for our delivery of test
reports. We have implemented adjustments to our operations designed to keep employees safe and comply with
federal, state and local guidelines, including those regarding social distancing.
•
Following the onset of the COVID-19 pandemic, we began experiencing declines in orders and test report volume. For
example, in the second quarter of 2020, test reports delivered for our lead product, DecisionDx-Melanoma, decreased
18.5% compared to the second quarter of 2019. For the year ended December 31, 2020, our growth in DecisionDx-
Melanoma test report volume was 4.5%, compared to year-over-year growth of 29.1% for the year ended December
31, 2019. We believe the adverse impacts to our test report volume growth are linked to delays and/or cancellations in
76
patient visits, resulting in reduced diagnostic biopsies and thus reduced diagnoses of cutaneous melanoma in response
to COVID-19.
•
Our future results will be dependent upon the extent and duration of the COVID-19 crisis as well as the impact of
ongoing state and local government restrictions, which are beyond our control, and which may be eased and/or
reinstated from time to time depending on the circumstances, potentially impacting the flow of future patient visits.
Even with the easing of state and local restrictions, patient visits and diagnosis of cutaneous melanoma may be
impacted by continued apprehension regarding possible exposure to the virus. For example, our analysis of third party
data indicates that during 2020, cutaneous melanoma diagnoses were down more than 20% compared to 2019.
• We continue to believe our cash and cash equivalents and anticipated cash to be generated from sales of our products,
will be sufficient to fund our operations for the foreseeable future.
As conditions are continuously evolving, we are unable to predict how our future test report volume will be impacted or the
extent to which our results of operations, financial condition or cash flows will be impacted by the COVID-19 pandemic, or
other future public health crises. Accordingly, the test report data presented above is not necessarily indicative of our results of
operations that can be expected for future periods. For more information on the potential impact of the COVID-19 pandemic on
our business, see the risk factors included under “Risks Related to Our Business” and the other risk factors included in Part I,
Item 1A., “Risk Factors,” of this Annual Report on Form 10-K.
Factors affecting our performance
We believe there are several important factors that have impacted and that we expect will impact our operating performance and
results of operations, including:
•
•
Report volume. We believe that the number of reports we deliver to physicians is an important indicator of growth of
adoption among the healthcare provider community. Our revenue and costs are affected by the volume of testing and
mix of customers. Our performance depends on our ability to retain and broaden adoption with existing prescribing
physicians, as well as attract new physicians. In the near term, our report volume may continue to be negatively
impacted by the effects of the COVID-19 pandemic, as the crisis evolves, as discussed above.
Reimbursement. We believe that expanding reimbursement is an important indicator of the value of our products.
Payors require extensive evidence of clinical utility, clinical validity, patient outcomes and health economic benefits in
order to provide reimbursement for diagnostic products. Our revenue depends on our ability to demonstrate the value
of our products to these payors.
• Gross margin. We believe that our gross margin is an important indicator of the operating performance of our
business. Higher gross margins reflect the average selling price of our tests, as well as the operating efficiency of our
laboratory operations.
•
New product development. A significant aspect of our business is our investment in research and development
activities, including activities related to the development of new products. In addition to the development of new
product candidates, we believe these studies are critical to gaining physician adoption of new products and driving
favorable coverage decisions by payors for such products.
Information about certain metrics
The following provides additional information about certain metrics we have disclosed in this Management’s Discussion and
Analysis of Financial Condition and Results of Operation.
Test reports delivered for DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-SCC represents the number of completed
test reports delivered by us during the reporting period indicated. The period in which a test report is delivered does not
necessarily correspond with the period the related revenue, if any, is recognized, due to the timing and amount of adjustments
for variable consideration under ASC 606. We use this metric to evaluate the growth in adoption of our tests and to measure
against our internal performance objectives. We believe this metric is useful to investors in evaluating the volume of our
business activity from period to period that may not be discernible from our reported revenues under ASC 606. We also
sometimes present, on a limited basis, data on the number of orders received. We believe order data can provide additional
insight on current demand trends, particularly during the COVID-19 pandemic and with respect to new product launches, when
considered in conjunction with test report volume. However, orders received in a particular period do not necessarily
correspond with actual delivered test reports or reported revenues for the same period or subsequent periods.
New ordering clinicians for DecisionDx-Melanoma represents the number of clinicians who ordered the DecisionDx-Melanoma
test for the first time during the reporting period specified. We believe this metric is useful in evaluating the effectiveness of our
77
sales and marketing efforts in establishing new relationships with clinicians and increasing the adoption of the DecisionDx-
Melanoma test. We also believe this metric provides useful information to investors in assessing our ability to expand the use of
the DecisionDx-Melanoma test. Since this metric is based upon the reporting period in which an order is placed, it does not
necessarily correspond to the reporting period in which a test report was delivered or in which any revenue was recognized.
Components of the Results of Operations
Net Revenues
We generate revenues from the sale of our products. Currently, our revenues are primarily derived from the sale of DecisionDx-
Melanoma and DecisionDx-UM. We bill third-party payors and patients for the tests we perform.
Under ASC 606, we recognize revenue at the amount we expect to be entitled, subject to a constraint for variable consideration,
in the period in which our tests are delivered to the treating physicians. We have determined that our contracts contain variable
consideration under ASC 606 because the amounts paid by third-party payors may be paid at less than our standard rates or not
paid at all, with such differences considered implicit price concessions. Variable consideration is recognized only to the extent
it is probable that a significant reversal of revenue will not occur in future periods when the uncertainties are resolved. Variable
consideration is evaluated each reporting period and adjustments are recorded as increases or decreases in revenues. Variable
consideration for Medicare claims that are not covered by an LCD, including those claims subject to approval by an ALJ at an
appeal hearing, is deemed to be fully constrained due to factors outside our influence (i.e., judgment or actions of third parties)
and the uncertainty of the amount to be received is not expected to be resolved for a long period of time. For these fully
constrained claims, we generally recognize revenue in the period the uncertainty is favorably resolved, if at all. Due to potential
future changes in Medicare coverage policies and appeal cycles, insurance coverage policies, contractual rates and other trends
in the reimbursement of our tests, our revenues may fluctuate significantly from period to period. Additionally, our ability to
recognize revenue for our recently launched tests, DecisionDx-SCC and DecisionDx DiffDx-Melanoma, is dependent on the
development of reimbursement experience and coverage decisions for these tests. Due to limited reimbursement experience, we
are currently recognizing revenues for these two tests on the basis of actual cash collections.
Our ability to increase our revenues will depend on our ability to further penetrate our target market, and, in particular, generate
sales through our direct sales force, develop and commercialize additional tests, obtain reimbursement from additional third-
party payors and increase our reimbursement rate for tests performed.
Cost of Sales
The components of our cost of sales are material and service costs, personnel costs (including salaries, bonuses, benefits and
stock-based compensation expense), equipment and infrastructure expenses associated with testing samples, electronic medical
records, order and delivery systems, shipping charges to transport samples, third-party test fees, and allocated overhead
including rent, information technology costs, equipment depreciation and utilities. Costs associated with performing tests are
recorded when the test is processed regardless of whether and when revenues are recognized with respect to that test. As a
result, our cost of sales as a percentage of revenues may vary significantly from period to period because we do not recognize
all revenues in the period in which the associated costs are incurred. We expect cost of sales in absolute dollars to increase as
the number of tests we perform increases. Additionally, we expect cost of sales to increase with the expansion of laboratory
capacity and staffing in advance of anticipated growth of our recently launched tests.
Gross margin, calculated as net revenues minus cost of sales, and gross margin percentage, calculated as gross margin divided
by net revenues, are key indicators we use to assess our business.
Research and Development
Research and development expenses include costs incurred to develop our genomic tests, collect clinical samples and conduct
clinical studies to develop and support our products. These costs consist of personnel costs (including salaries, bonuses, benefits
and stock-based compensation expense), prototype materials, laboratory supplies, consulting costs, regulatory costs, electronic
medical records set up costs, costs associated with setting up and conducting clinical studies 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.
We expect to use a portion of the proceeds from the June 2020 and December 2020 follow-on public offerings to further
support and accelerate our research and development activities, including two important studies that we have recently
commenced to support our DecisionDx-Melanoma test. The first is the PERSONALize study, in which we are evaluating
DecisionDx-Melanoma for interactions with adjuvant therapies. The second is the CONNECTION study, which is collecting
long-term outcomes for up to 10,000 patients who have been tested with DecisionDx-Melanoma.
78
Selling, General and Administrative
Selling, general and administrative, or SG&A, expenses include executive, selling and marketing, legal, finance and accounting,
human resources, billing and client services. These expenses consist of personnel costs (including salaries, bonuses, benefits
and stock-based compensation expense), direct marketing expenses, audit and legal expenses, consulting costs, training and
medical education activities, payor outreach programs and allocated overhead, including rent, information technology,
equipment depreciation, and utilities. We expect continued increases in SG&A expenses related to compliance with the rules
and regulations of the SEC and Nasdaq, investor relations activities and additional insurance expenses. Other administrative and
professional services expenses within SG&A are expected to increase with the scale of our business, but selling and marketing-
related expenses are expected to increase significantly, consistent with our growth strategy.
Other Operating Income
Other operating income consists of an automatic payment received from HHS for provider relief funds pursuant to the CARES
Act.
Interest Income
Interest income consists primarily of earnings on cash and cash equivalents, primarily money market funds.
Interest Expense
Interest expense is attributable to borrowings under our term debt, revolving line of credit and the convertible promissory notes
issued in January and February of 2019, or the Q1 2019 Notes, and also includes the amortization of debt discount and issuance
costs.
(Loss) Gain on Extinguishments of Debt
The loss on extinguishment of debt is associated with the early repayment of our term loan facility in December 2020 while the
gain on extinguishment of debt is associated with the settlement of the Q1 2019 Notes in connection with the IPO.
Other Expense, Net
Other expense, net reflects changes in the fair value of (i) a convertible promissory note we issued to an investor in July 2019,
or the July 2019 Note, (ii) our convertible preferred stock warrant liability and (iii) the embedded derivative associated with the
Q1 2019 Notes.
Income Tax Expense
Our financial statements do not reflect any federal or state income tax benefits attributable to the net losses we have incurred,
due to the uncertainty of realizing a benefit from those items. As of December 31, 2020, we had federal net operating loss
carryforwards of $55.9 million, of which $42.0 million will begin to expire in 2033 if not utilized to offset federal taxable
income and $13.9 million may be carried forward indefinitely. Also, as of December 31, 2020, we had state net operating loss
carryforwards of $41.6 million, which begin to expire in 2028 if not utilized to offset state taxable income.
79
Results of Operations
Comparison of the years ended December 31, 2020 and 2019
The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):
Net revenues
Cost of sales
Gross margin
Gross margin percentage
Operating expenses and other operating income:
Research and development
Selling, general and administrative
Other operating income
Total operating expenses, net
Operating (loss) income
Interest income
Interest expense
(Loss) gain on extinguishments of debt
Other expense, net
(Loss) income before income taxes
Income tax expense
Net (loss) income
Years Ended December 31,
2020
2019
Change
$
62,649
$
51,865
$
10,784
9,685
52,964
7,310
44,555
84.5 %
85.9 %
13,256
48,132
(1,882)
59,506
(6,542)
373
(2,634)
(1,397)
—
(10,200)
84
7,385
29,842
—
37,227
7,328
312
(4,571)
5,213
(2,933)
5,349
72
2,375
8,409
5,871
18,290
(1,882)
22,279
61
1,937
(6,610)
2,933
(15,549)
12
$
(10,284)
$
5,277
$
(15,561)
20.8 %
32.5 %
18.9 %
79.5 %
61.3 %
N/A
59.8 %
19.6 %
42.4 %
(126.8) %
100.0 %
(290.7) %
16.7 %
(294.9) %
(13,870)
(189.3) %
The following table indicates the amount of stock-based compensation expense reflected in the line items above (in thousands):
Cost of sales
Research and development
Selling, general and administrative
Total stock-based compensation expense
Net Revenues
Years Ended December 31,
2020
2019
Change
$
$
1,049 $
170 $
1,492
5,768
165
914
8,309 $
1,249 $
879
1,327
4,854
7,060
Net revenues increased by $10.8 million, or 20.8%, to $62.6 million primarily due to higher per-unit revenues as well as an
increase in overall test report volume, partially offset by reduced revenue adjustments related to prior periods. The overall
revenue increase is primarily attributable to DecisionDx-Melanoma test revenues, partially offset by lower DecisionDx-UM test
revenues. Our 2020 per-unit revenues benefited from having the “new ADLT” status for our DecisionDx-Melanoma test,
effective July 1, 2019, which resulted in a higher Medicare reimbursement rate for the test, as described above, for the full year
in 2020. For the year ended December 31, 2020, we experienced an increase in DecisionDx-Melanoma test volume of 4.5% but
a decrease in DecisionDx-UM test report volume of 8.6%, compared to the year ended December 31, 2019. For these two tests,
while we saw a year-over-year increase in test reports delivered of 37.4% during the first quarter of 2020, we experienced year-
over-year (decreases) increases in test reports delivered of (18.5%), 5.4% and (5.3%) during the second, third and fourth
quarters, respectively, of 2020. We believe the adverse impacts to our test report volume growth are linked to delays and/or
cancellations in patient visits, resulting in reduced diagnostic biopsies and thus reduced diagnoses of cutaneous melanoma in
response to COVID-19, as discussed above. For the years ended December 31, 2020 and 2019, we recorded net positive
revenue adjustments of $0.2 million and $2.5 million, respectively, related to tests delivered in previous periods, associated
with changes in estimated variable consideration. The positive revenue adjustments include the recognition of revenue for
80
certain tests delivered in prior periods for which no revenue was recognizable originally, but was recognized upon cash
collection of payments for the tests in the respective periods.
Cost of Sales
Cost of sales for the year ended December 31, 2020 increased by $2.4 million, or 32.5%, compared to the year ended
December 31, 2019, primarily due to increased costs of supplies and services, attributable to the higher activity levels, as well
as higher personnel costs due to additional headcount in our laboratory testing operations. The additional personnel costs
included a year-over-year increase in stock-based compensation expense of $0.9 million. Our gross margin percentage was
84.5% for the year ended December 31, 2020, compared to 85.9% for the same period in 2019, reflecting the expansion of
laboratory staff in preparation for both launches of DecisionDx-SCC and DecisionDx DiffDx-Melanoma as well as anticipated
further volume growth for DecisionDx-Melanoma. Due to the nature of our business, a significant portion of our cost of sales
expenses represent fixed costs associated with our testing operations. Accordingly, our cost of sales expense will not
necessarily increase or decrease commensurately with the change in net revenues from period to period.
Research and Development
Research and development expenses increased by $5.9 million, or 79.5%, for the year ended December 31, 2020, compared to
the year ended December 31, 2019, primarily associated with increases in personnel costs and costs incurred in our clinical
studies. Personnel costs increased due to expansions in headcount in support of our growth, including higher stock-based
compensation expense, which increased by $1.3 million.
Selling, General and Administrative
SG&A expense increased by $18.3 million, or 61.3%, for the year ended December 31, 2020 compared to the year ended
December 31, 2019. Approximately 68% of the increase is attributable to higher personnel costs, particularly due to increased
headcount, which includes salaries, bonuses, benefits and stock-based compensation. In early 2019, we expanded our sales
organization from 14 territories to 23 territories and implemented an additional expansion to 32 territories beginning in
December 2019. Further, we expanded our sales organization headcount in the third quarter of 2020 in preparation for the
commercial launch of our DecisionDx DiffDx-Melanoma test. The higher personnel costs also reflect expanded headcount in
our administrative support functions. Stock-based compensation expense included in SG&A expense was $5.8 million for the
year ended December 31, 2020 compared to $0.9 million for the year ended December 31, 2019, reflecting both higher post-
IPO stock option valuations as well as additional awards outstanding due to growth in headcount. The remainder of the increase
in SG&A expense was primarily associated with higher marketing expenses, professional fees, board of director compensation,
insurance expense and other general increases.
Other Operating Income
Other operating income of $1.9 million for the year ended December 31, 2020 consists entirely of the automatic payment
received from HHS pursuant to the CARES Act for provider relief funds. We initially recognized income attributable to the
payment in the second quarter of 2020 based on our expectation of meeting the requirements to retain the funds. However, due
a change in requirements of the program in the third quarter of 2020, we reversed this income. However, in the fourth quarter of
2020, a legislative change was enacted affecting the program, under which we concluded it is reasonably assured we will
qualify to retain the funds. Accordingly, we recognized the income again in the fourth quarter of 2020. See Note 2 to the
financial statements for additional information.
Interest Income
Interest income increased by $0.1 million for the year ended December 31, 2020, compared to the year ended December 31,
2019, as a result of higher average balances of cash and cash equivalents, largely offset by the effect of lower interest rates. The
higher average balances of cash and cash equivalents were primarily attributable to proceeds from the IPO in 2019 and two
public offerings of common stock in 2020.
Interest Expense
Interest expense decreased by $1.9 million, or 42.4%, for the year ended December 31, 2020 compared to the year ended
December 31, 2019 and was primarily attributable to interest expense on the Q1 2019 Notes during the year ended
December 31, 2019, which was $1.7 million, and consisted of the accrual of the contractual 8% interest plus the amortization of
issuance costs and debt discount. The outstanding principal amount and accrued interest on the Q1 2019 Notes converted into
shares of common stock in connection with the IPO in July 2019. The decrease also reflects lower interest expense on our
banking term loan facility primarily due to lower average balances outstanding. We terminated and repaid all amounts due on
the term loan facility in December 2020, as discussed further below.
81
(Loss) Gain on Extinguishments of Debt
We recorded an extinguishment loss of $1.4 million during the year ended December 31, 2020 related to the early repayment
and termination of our banking term loan facility. The extinguishment loss was attributable to the write off of the unamortized
discount and issuance costs as well as early termination and prepayment fees. During the year ended December 31, 2019, we
recorded a non-cash extinguishment gain related to the Q1 2019 Notes totaling $5.2 million, which was associated with the
conversion of the Q1 2019 Notes into shares of common stock in connection with the IPO that was considered an
extinguishment for accounting purposes. See Notes 6 and 7 to the financial statements for additional information on these
extinguishments of debt.
Other Expense, Net
Other expense, net for the year ended December 31, 2019 consisted of losses associated with changes in fair value of the July
2019 Note, the liability for convertible preferred stock warrants and the embedded derivative associated with the Q1 2019
Notes of $2.1 million, $0.6 million and $0.2 million, respectively. These liabilities were adjusted to their current fair values
each period, but effective with the IPO, the July 2019 Note and Q1 2019 Notes automatically converted into shares of common
stock and we reclassified our liability for convertible preferred stock warrants to stockholders’ equity. Accordingly, no further
changes in fair value for these items are reflected in periods after the IPO date.
Income Tax Expense
We recorded minimal income tax expense in both the years ended December 31, 2020 and 2019, because the income tax
(benefit) expense of net (loss) income in both periods was largely offset by changes in the valuation allowance on net deferred
tax assets, as we have determined that it is more likely than not that these benefits will not be realized.
Stock-Based Compensation Expense
Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A
expense, totaled $8.3 million for the year ended December 31, 2020 compared to $1.2 million for the year ended December 31,
2019. We expect material increases in stock-based compensation expense in future periods, reflecting both higher post-IPO
stock option valuations as well as additional awards outstanding due to growth in our headcount. As of December 31, 2020 we
had 201 employees compared to 135 as of December 31, 2019. As of December 31, 2020, the total unrecognized stock-based
compensation cost related to outstanding awards was $57.1 million, which is expected to be recognized on a straight-line basis
over a weighted-average period of 3.4 years. We expect to continue granting stock-based compensation awards, which we
expect to further contribute to increases in stock-based compensation expense in future periods.
Liquidity and Capital Resources
Sources of Liquidity
Our principal sources of liquidity are our cash and cash equivalents and cash generated from sales of our products. As of
December 31, 2020 and 2019, we had cash and cash equivalents of $409.9 million and $98.8 million, respectively. To date, in
addition to the revenue generated from the sale of our products, we have financed our operations through the IPO, two follow-
on public offerings of common stock in June 2020 and December 2020, private placements of preferred stock, convertible
promissory notes and bank debt.
On December 14, 2020, we filed an automatically effective shelf registration statement on Form S-3 (File No. 333-251331)
with the SEC as a “well-known seasoned issuer.” The registration statement allows us to issue an indeterminate number or
amount of common stock, preferred stock, debt securities and warrants from time to time in one or more offerings. However,
there can be no assurance that we will complete any such offerings of securities. Any future offerings under this registration
statement will be dependent upon, among other factors, market conditions, available pricing, our financial condition, investor
perception of our prospects, our capital needs and our ability to maintain status as a well-known seasoned issuer.
Public Offerings of Common Stock
In connection with the closing of the IPO on July 29, 2019, we issued and sold 4,600,000 shares of our common stock,
including 600,000 shares associated with the full exercise of the underwriters’ option to purchase additional shares, at a price to
the public of $16.00 per share. We received approximately $65.9 million in net proceeds, after deducting underwriting
discounts and commissions and other offering expenses payable to us.
On June 29, 2020 and July 2, 2020, we issued and sold 2,000,000 and 300,000 shares, respectively, of our common stock in a
follow-on public offering at a price of $37.00 per share. We received $79.5 million in aggregate net proceeds, after deducting
82
underwriting discounts and commissions and offering costs. The shares issued and sold on July 2, 2020 reflect the underwriters’
exercise in full of their 30-day option to purchase additional shares at the public offering price, less underwriting discounts and
commissions.
On December 18, 2020, we issued and sold 4,600,000 shares of our common stock in a follow-on public offering at a price of
$58.00 per share. We received $250.5 million in aggregate net proceeds, after deducting underwriting discounts and
commissions and offering costs (excluding $0.4 million in offering costs that were incurred but not paid as of December 31,
2020). The shares issued and sold includes the underwriters’ exercise in full of their 30-day option to purchase additional shares
at the public offering price, less underwriting discounts and commissions. On December 21, 2020, we used a portion of these
proceeds to repay, in full, our outstanding term loan credit facility. See “Long-Term Debt” below for additional information.
As mentioned above, we expect to use a portion of these proceeds to further support and accelerate our research and
development activities, including two important studies that we have recently commenced to support our DecisionDx-
Melanoma test.
Medicare Advance Payment
On April 16, 2020, we received an advance payment of $8.3 million, or the Advance Payment, from CMS under its Accelerated
and Advance Payment Program, which was expanded to provide increased cash flow to service providers during the COVID-19
pandemic. We have recorded the Advance Payment as a liability, consisting of both a current and noncurrent portion, on our
balance sheet as of December 31, 2020. We will reduce the balance of the Advance Payment as it is applied to claims or is
otherwise recouped by CMS. Under the Continuing Appropriations Act, 2021 and Other Extensions Act, enacted on October 1,
2020, the recoupment of the Advance Payment will commence in April 2021. For the first eleven months of recoupment, CMS
will apply 25% of the Medicare payments otherwise owed to us against the balance of the Advance Payment. After that eleven-
month period, CMS will recoup at a rate of 50% of the Medicare payments otherwise owed to us for an additional six months.
If the Advance Payment is not fully recovered by CMS after this recoupment period, we will be required to repay any
remaining balance.
Funding Requirements
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, clinical research and
development services, laboratory operations, equipment and related supplies, legal and other regulatory expenses, general
administrative costs and, from time to time, expansion of our facilities in support of our growth. We anticipate that a substantial
portion of our capital resources and efforts in the foreseeable future will be focused on the commercialization of our existing
products, the development of our future product candidates, the potential commercialization of our product candidates, should
their development be successful, and general administrative costs. We may also, from time to time, consider various strategic
opportunities, which may involve using a portion of our capital resources to fund acquisitions of businesses, assets, products or
technologies.
Since our inception, we have generally incurred significant losses and negative cash flows. For the year ended December 31,
2020 we had a net loss of $10.3 million and an accumulated deficit of $62.5 million as of December 31, 2020. Our ability to
generate revenue sufficient to achieve profitability will depend heavily on the successful commercialization of our currently
marketed products and the products we plan to launch in the future as well as our spending on research and development
activities. We expect to incur additional expenses and losses in the future as we invest in the commercialization of our existing
products, the development of our future product candidates and the commercialization of our product candidates. We believe
that our existing cash and cash equivalents and anticipated cash generated from sales of our products will be sufficient to fund
our operations for the foreseeable future. However, we have based these estimates on assumptions that may prove to be wrong,
and we could utilize our available capital resources sooner than we expect. There are numerous risks and uncertainties
associated with developing genomic tests, including, among others, the uncertainty of:
•
•
•
•
successful commencement and completion of clinical study protocols;
successful identification and acquisition of tissue samples;
the development and validation of genomic classifiers; and
acceptance of new genomic tests by physicians, patients and third-party payors.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product
candidates, we are unable to estimate our exact working capital requirements. Our future funding requirements will depend on
83
and could increase significantly as a result of many factors, including those listed above as well as those listed in Part I, Item
1A., “Risk Factors,” of this Annual Report on Form 10-K.
We do not currently have any committed external source of funds. In the event additional funding is required, we expect that we
would use a combination of equity and debt financings, which may not be available to us when needed, on terms that we deem
to be favorable or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities,
the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other
preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available,
may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring
additional debt, making acquisitions or capital expenditures or declaring dividends. As a result of the COVID-19 crisis and
actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility, including
diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in
unemployment rates and uncertainty about economic stability. There can be no assurance that further deterioration in credit and
financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make
any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. If we are unable to raise
additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit,
reduce or terminate our product discovery and development activities or future commercialization efforts.
Long-Term Debt
Our long-term debt balances are presented in the table below (in thousands):
Term debt
Unamortized discount and issuance costs
Total long-term debt
Less: Current portion of long-term debt
Long-term debt, less current portion
Years Ended December 31,
2020
2019
$
$
— $
—
—
—
— $
26,688
(1,566)
25,122
(5,833)
19,289
We had a Loan and Security Agreement, or the 2018 LSA, with Oxford Finance LLC, or Oxford, as collateral agent, and
Oxford and Silicon Valley Bank as equal syndicated lenders. The 2018 LSA consisted of a $25.0 million secured term loan
credit facility, or the Term Loan. The Term Loan bore interest at a floating rate equal to the greater of (1) 8.55% and (2) the 30-
day U.S. LIBOR rate as reported in The Wall Street Journal on the last business day of the month that precedes the month in
which the interest will accrue, plus 6.48%. The applicable interest rate on the Term Loan was 8.55% as of December 31, 2019.
We were permitted to make interest-only payments on the Term Loan through May 31, 2020. As required, we began to repay
the principal in 30 equal monthly installments of $833,333 each beginning on June 1, 2020. All unpaid principal and accrued
and unpaid interest was to be due at maturity on November 1, 2022. However, on December 21, 2020, we terminated the 2018
LSA and repaid in full all amounts due, which totaled $21.6 million as of such date, including the outstanding principal balance,
the final payment amount, early termination and prepayment fees and accrued interest.
For additional information on the 2018 LSA, refer to Note 7, “Long-Term Debt,” in the accompanying notes to our audited
financial statements included in this Annual Report on Form 10-K.
Operating Leases
We have entered into various operating leases, which are primarily associated with our laboratory facilities and office space.
Total future minimum payment obligations under our operating leases as of December 31, 2020 totaled approximately
$6.8 million. The leases expire on various dates through 2028 and provide certain options to renew for additional periods. Refer
to Note 8 to the financial statements for additional information on our leasing arrangements.
84
Cash Flows
The following table summarizes our sources and uses of cash and cash equivalents for each of the periods presented (in
thousands):
Net cash provided by operating activities
Net cash used in investing activities
Net cash provided by financing activities
Net increase in cash and cash equivalents
Cash and cash equivalents, beginning of year
Cash and cash equivalents, end of year
Operating Activities
Years Ended December 31,
2020
2019
$
9,865 $
7,015
(4,748)
(937)
305,890
311,007
98,845
88,288
94,366
4,479
$ 409,852 $
98,845
Net cash provided by operating activities was $9.9 million for the years ended December 31, 2020 and was primarily
attributable to net non-cash charges of $10.5 million (consisting of $8.3 million in stock-based compensation expense, $1.4
million of loss on extinguishment of debt, and $0.8 million in amortization of debt discount and issuance costs), the receipt of
the Advance Payment of $8.3 million, increases in accrued compensation of $3.3 million and decreases in accounts receivable
of $1.7 million, partially offset by the net loss of $10.3 million and increases in prepaid expenses and other current assets of
$2.8 million, other assets of $1.4 million and inventory of $1.0 million.
Net cash provided by operating activities was $7.0 million for the year ended December 31, 2019 and was primarily attributable
to net income of $5.3 million and net non-cash charges of $1.7 million (consisting of $2.1 million of fair value adjustments,
$1.9 million in amortization of debt discount and issuance costs, stock-based compensation expense of $1.2 million, preferred
stock warrant fair value adjustments of $0.6 million, and $1.1 million of other items, partially offset by $5.2 million of a debt
extinguishment gain).
Investing Activities
Net cash used in investing activities for the years ended December 31, 2020 and 2019 consisted entirely of purchases of
property and equipment. The increase in purchases of property and equipment for the year ended December 31, 2020 compared
to the year ended December 31, 2019 was primarily associated with the expansion of our facilities.
Financing Activities
Net cash provided by financing activities was $305.9 million for the year ended December 31, 2020 and consisted primarily of
$330.0 million of proceeds from two common stock offering (net of underwriting discounts, commissions and issuance costs),
$1.6 million of proceeds from contributions to the employee stock purchase plan and $1.6 million of proceeds from exercise of
common stock options, partially offset by repayments of term debt, including extinguishment costs, of $27.4 million.
Net cash provided by financing activities was $88.3 million for the year ended December 31, 2019 and consisted primarily of
$65.9 million of proceeds from our IPO (net of underwriting discounts, commissions and issuance costs), $11.7 million of net
proceeds from the issuance of the Q1 2019 Notes, $9.2 million of net proceeds from the issuance of the July 2019 Note, $1.8
million of net proceeds associated with an increase in the 2018 Term Loan in connection with an amendment to the 2018 LSA
and $1.2 million of proceeds from the exercise of stock options, partially offset by principal repayments of $1.8 million on our
line of credit.
Contractual Obligations and Commitments
Not required for smaller reporting companies.
Off-Balance Sheet Arrangements
We do not currently have, nor did we have any off-balance sheet arrangements, as defined in the rules and regulations of the
SEC, during the periods presented.
85
Critical Accounting Policies and Significant Judgments and Estimates
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States of
America. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that
affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our
financial statements. We base our estimates on historical experience, known trends and events and various other factors that we
believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on
an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 to our audited financial statements, we believe
that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our
financial statements.
Revenue Recognition
We recognize revenue in accordance with ASC 606. In accordance with ASC 606, we follow a five-step process to recognize
revenues: (1) identify the contract with the customer; (2) identify the performance obligations; (3) determine the transaction
price; (4) allocate the transaction price to the performance obligation; and (5) recognize revenues when the performance
obligations are satisfied.
All of our revenues from contracts with customers are associated with the provision of diagnostic and prognostic cancer testing
services. Most of our revenues are attributable to DecisionDx-Melanoma for cutaneous melanoma. We also provide a test for
uveal melanoma, DecisionDx-UM. We launched a test for patients with cutaneous squamous cell carcinoma, DecisionDx-SCC
in August 2020 and launched a test for use in patients with suspicious pigmented lesions, DecisionDx DiffDx-Melanoma in
November 2020.
We have determined that we have a contract with the patient when the treating clinician orders the test. Our contracts generally
contain a single performance obligation, which is the delivery of the test report, and we satisfy our performance obligation at
the point in time when we deliver the test report to the treating clinician, at which point we can bill for the report. The amount
of revenue recognized reflects the amount of consideration we expect to be entitled, or the transaction price, and considers the
effects of variable consideration, which is discussed further below.
Once we satisfy our performance obligations and bill for the service, the timing of the collection of payments may vary based
on the payment practices of the third-party payor and the existence of contractually established reimbursement rates. Most of
the payments for our services are made by third-party payors, including Medicare and commercial health insurance carriers.
Certain contracts contain a contractual commitment of a reimbursement rate that differs from our list prices. However, absent a
contractually committed reimbursement rate with a commercial carrier or governmental program, our diagnostic tests may or
may not be covered by these entities’ existing reimbursement policies. In addition, patients do not enter into direct agreements
with us that commit them to pay any portion of the cost of the tests in the event that their insurance provider declines to
reimburse us. We may pursue, on a case-by-case basis, reimbursement from such patients in the form of co-payments and co-
insurance, in accordance with the contractual obligations that we have with the insurance carrier or health plan. These situations
may result in a delay in the collection of payments.
The Medicare claims that are covered by policy under an LCD are generally paid at the established rate by our Medicare
contractor within 30 days from receipt. Medicare claims that were either submitted to Medicare prior to the LCD’s effective
date or are not covered by the terms of the LCD, but meet the definition of being medically reasonable and necessary pursuant
to the controlling Section 1862(a)(1)(A) of the Social Security Act are generally appealed and may ultimately be paid at the first
(termed “redetermination”), second (termed “reconsideration”) or third level of appeal (de novo hearing with an ALJ). A
successful appeal at any of these levels results in payment.
In the absence of LCD coverage or contractually established reimbursement rates, we have concluded that our contracts include
variable consideration because the amounts paid by Medicare or commercial health insurance carriers may be paid at less than
our standard rates or not paid at all, with such differences considered implicit price concessions. Variable consideration
attributable to these price concessions is measured at the expected value using the “most likely amount” method under ASC
606. The amounts are determined by historical average collection rates by test type and payor category taking into consideration
the range of possible outcomes, the predictive value of our past experiences, the time period of when uncertainties expect to be
resolved and the amount of consideration that is susceptible to factors outside of our influence, such as the judgment and
actions of third parties. Such variable consideration is included in the transaction price only to the extent it is probable that a
significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the
amount are resolved. Variable consideration may be constrained and excluded from the transaction price in situations where
there is no contractually agreed upon reimbursement coverage or in the absence of a predictable pattern and history of
collectability with a payor. Variable consideration for Medicare claims that are not covered by an LCD, including those claims
86
subject to approval by an ALJ at an appeal hearing, is deemed to be fully constrained due to factors outside our influence (i.e.,
judgment or actions of third parties) and the uncertainty of the amount to be received is not expected to be resolved for a long
period of time. Variable consideration is evaluated each reporting period and adjustments are recorded as increases or decreases
in revenues. Included in revenues for the years ended December 31, 2020 and 2019 were $176,000 and $2,493,000,
respectively, of revenue increases associated with changes in estimated variable consideration related to performance
obligations satisfied in previous periods. These amounts include (i) adjustments for actual collections versus estimated amounts
and (ii) cash collections and the related recognition of revenue in current period for tests delivered in prior periods due to the
release of the constraint on variable consideration.
DecisionDx-Melanoma Claims Consolidation
In June 2017, we submitted to OMHA a formal request to participate in a program that OMHA developed with the intent of
providing appellants a means to have large volumes of claim disputes adjudicated at an accelerated rate. The program
consolidates outstanding claims at the ALJ level and uses a statistical-sampling approach where five ALJs will determine
reimbursement results for a sample of claims which are then extrapolated to the universe of claims. Our consolidation includes
2,698 DecisionDx-Melanoma claims dating from 2013 through spring 2017. Hearings were held in April 2019 with a
supplemental hearing in May 2019. On March 12, 2020, OMHA issued a decision denying payment on all claims in the
consolidation. We have filed an appeal to the decision, although no ruling on such appeal has been issued to date. In accordance
with ASC 606 and consistent with prior periods, we have not recognized (fully constrained the variable consideration) any
revenues attributable to these claims in our financial statements pending the outcome of this matter.
Stock-Based Compensation
Stock-based compensation expense for equity instruments issued to employees and non-employees, including stock options,
restricted stock units, or RSUs, and purchase rights issued under our 2019 Employee Stock Purchase Plan, or ESPP, is
measured based on the grant date fair value of the awards. For stock options and purchase rights granted under the ESPP, we
estimate the grant date fair value using the Black-Scholes option-pricing valuation model. For RSUs, we use the closing price
of our common stock on the date of grant to determine the fair value. We recognize compensation costs on a straight-line basis
for all stock-based compensation awards over the requisite service period of the awards, which is generally the awards’ vesting
period, which is typically four years for options and RSUs and the two-year offering period for the ESPP. Forfeitures are
accounted for as they occur.
Following is a description of the significant assumptions used in the option pricing model:
•
•
•
•
Expected term. The expected term is the period of time that granted options are expected to be outstanding. For stock
options, we have set the expected term using the simplified method based on the weighted average of both the period
to vesting and the period to maturity for each option, as we have concluded that our stock option exercise history does
not provide a reasonable basis upon which to estimate the expected term. For the ESPP, the expected term is the period
of time from the offering date to the purchase date.
Expected volatility. Because of the limited period of time our stock has been traded in an active market, we calculate
volatility by using the historical stock prices of a group of similar companies looking back over the estimated life of
the option or the ESPP purchase right and averaging the volatilities of these companies.
Risk-free interest rate. We base the risk-free interest rate used in the Black-Scholes valuation model on the market
yield in effect at the time of option grant and at the offering date for ESPP provided from the Federal Reserve Board’s
Statistical Releases and historical publications from the Treasury constant maturities rates for the equivalent remaining
terms.
Dividend yield. We have not paid, and do not have plans to pay, cash dividends. Therefore, we use an expected
dividend yield of zero in the Black-Scholes option valuation model.
The fair value of our common stock is also an assumption used to determine the fair value of stock options. Prior to the IPO, the
estimated fair value of our common stock had been determined by our board of directors as of the date of each award, with
input from management, considering our most recently available third-party valuations of common stock and our board of
directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed
from the date of the most recent valuation through the date of the grant, which intended all options granted to be exercisable at
price per share not less than the per share fair value of our common stock underlying those options on the grant date.
Subsequent to the IPO, the fair value of our common stock is the closing selling price per share of our common stock as
reported on the Nasdaq Global Market on the date of grant or other relevant determination date.
87
The following table sets forth the assumptions used to determine the fair value of stock options:
Average expected term (years)
Expected stock price volatility
Risk-free interest rate
Dividend yield
Years Ended December 31,
2020
6
2019
6
59.57% - 67.02%
56.74%- 60.17%
0.28% - 1.76%
1.63% - 2.47%
—%
—%
The following table sets forth assumptions used to determine the fair value of the purchase rights issued under the ESPP:
Average expected term (years)
Expected stock price volatility
Risk-free interest rate
Dividend yield
Recent Accounting Pronouncements
Years Ended December 31,
2020
1.2
2019
1.2
56.80% - 100.49%
61.12% - 68.89%
0.12% - 0.95%
1.56% - 1.80%
—%
—%
Refer to Note 2, ‘‘Summary of Significant Accounting Policies,’’ in the accompanying notes to our financial statements
included in this Annual Report on Form 10-K for a discussion of recent accounting pronouncements.
JOBS Act Accounting Election
We are an emerging growth company within the meaning of the JOBS Act. Section 107(b) of the JOBS Act provides that an
emerging growth company can leverage the extended transition period, provided in Section 102(b) of the JOBS Act, for
complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of new or
revised accounting standards that have different effective dates for public and private companies until those standards apply to
private companies. We have elected to use this extended transition period and, as a result, our financial statements may not be
comparable to companies that comply with public company effective dates. We also intend to rely on other exemptions
provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements
of Section 404(b) of Sarbanes-Oxley.
We will remain an emerging growth company until the earliest of (1) December 31, 2024, (2) the last day of the fiscal year (a)
in which we have total annual gross revenue of at least $1.07 billion or (b) in which we are deemed to be a ‘‘large accelerated
filer’’ as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by
non-affiliates exceeded $700.0 million as of the prior June 30th, and (3) the date on which we have issued more than $1.0 billion
in non-convertible debt securities during the prior three-year period.
As of March 5, 2021, the market value of our common stock held by non-affiliates exceeded $700.0 million. If the market value
of our common stock held by non-affiliates exceeds $700.0 million as of June 30, 2021, we will cease to be an emerging growth
company effective December 31, 2021.
Item 7A. Qualitative and Quantitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide the information required by this Item.
Item 8. Financial Statements and Supplementary Data.
The financial statements and supplementary data required by this item are included after the Signature page of this Annual
Report on Form 10-K beginning on page F-1.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
88
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that
are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is
(1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2)
accumulated and communicated to our management, including our principal executive officer and principal financial officer, to
allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily
applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness
of our disclosure controls and procedures as of December 31, 2020. Based upon the evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that, as of December 31, 2020, our disclosure controls and procedures were effective at the
reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term
as defined in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision
and with the participation of our management, including our principal executive officer and principal financial officer, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with accounting principles generally accepted in the United States of America.
As of December 31, 2020, our management assessed the effectiveness of our internal control over financial reporting using the
criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated
Framework (2013 Framework). Based on this assessment, our management concluded that, as of December 31, 2020, our
internal control over financial reporting was effective based on those criteria.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the
Exchange Act) that occurred during the fourth quarter of 2020 that have materially affected, or are reasonably likely to
materially affect, the Company’s internal control over financial reporting.
Item 9B. Other Information.
None.
89
Item 10. Directors, Executive Officers and Corporate Governance.
PART III
The information required by this item and not set forth below will be contained in our definitive proxy statement to be filed
with the SEC in connection with our 2021 Annual Meeting of Stockholders, or the Proxy Statement, which is expected to be
filed not later than 120 days after the end of our fiscal year ended December 31, 2020, and is incorporated herein by reference.
We have adopted a written Code of Business Conduct and Ethics, or Ethics Code, that applies to all officers, directors and
employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or
persons performing similar functions. The Ethics Code is available on our website at www.CastleBiosciences.com. If we make
any substantive amendments to the Ethics Code or grant any waiver from a provision of the Ethics Code to any executive
officer or director, we will promptly disclose the nature of the amendment or waiver on our website or in a Current Report on
Form 8-K.
Item 11. Executive Compensation.
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services.
The information required by this item will be set forth in the Proxy Statement and is incorporated herein by reference.
90
Item 15. Exhibits, Financial Statement Schedules.
(a)(1) Financial Statements.
PART IV
The financial statements and supplementary data required by this item are included after the Signature page of this
Annual Report on Form 10-K beginning on page F-1.
(a)(2) Financial Statement Schedules.
All schedules have been omitted because they are not required or because the required information is given in the
Financial Statements or Notes thereto.
(a)(3) Exhibits.
The exhibits listed in the Exhibit Index below are filed or incorporated by reference as part of this Annual Report.
Exhibit
Number
3.1
3.2
4.1
4.2
4.3
10.1+
10.2+
10.3+
10.4+
10.5+
10.6+
10.7+
10.8+
10.9+
Exhibit Index
Description of document
Amended and Restated Certificate of Incorporation of the Registrant, incorporated by reference to Exhibit 3.1 of
the Registrant’s Current Report on Form 8-K filed with the SEC on July 29, 2019.
Amended and Restated Bylaws of the Registrant, incorporated by reference to Exhibit 3.2 of the Registrant’s
Current Report on Form 8-K filed with the SEC on July 29, 2019.
Description of securities registered under Section 12 of the Exchange Act, incorporated by reference to Exhibit
4.1 of the Registrant's Annual Report on Form 10-K filed with the SEC on March 10, 2020.
Form of Common Stock Certificate of the Registrant, incorporated by reference to Exhibit 4.1 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the
SEC on June 26, 2019.
Sixth Amended and Restated Investors’ Rights Agreement, dated July 12, 2019, by and among the Registrant
and certain of its stockholders, incorporated by reference to Exhibit 4.2 of the Registrant’s Registration
Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
Form of Indemnity Agreement by and between the Registrant and its directors and officers, incorporated by
reference to Exhibit 10.1 of the Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as
amended, originally filed with the SEC on June 26, 2019.
Castle Biosciences, Inc. 2008 Stock Plan, incorporated by reference to Exhibit 10.2 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June
26, 2019.
Forms of Stock Option Agreement, Exercise Notice and Investment Representation Statement under the 2008
Stock Plan, incorporated by reference to Exhibit 10.3 of the Registrant’s Registration Statement on Form S-1
(File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
Castle Biosciences, Inc. 2018 Equity Incentive Plan, as amended, incorporated by reference to Exhibit 10.4 of
the Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with
the SEC on June 26, 2019.
Forms of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the 2018 Equity
Incentive Plan, incorporated by reference to Exhibit 10.5 of the Registrant’s Registration Statement on Form S-1
(File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
Castle Biosciences, Inc. 2019 Equity Incentive Plan, incorporated by reference to Exhibit 10.6 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the
SEC on June 26, 2019.
Forms of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the 2019 Equity
Incentive Plan, incorporated by reference to Exhibit 10.7 of the Registrant’s Registration Statement on Form S-1
(File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the 2019
Equity Incentive Plan, incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form
10-Q filed with the SEC on November 9, 2020.
Castle Biosciences, Inc. 2019 Employee Stock Purchase Plan, incorporated by reference to Exhibit 10.8 of the
Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the
SEC on June 26, 2019.
91
Exhibit
Number
10.10+
10.11+*
10.12+
10.13+
10.14+
10.15+
10.16+
10.17
10.18
10.19
10.20
10.21
10.22
10.23*
10.24#
23.1*
31.1*
31.2*
32.1**
32.2**
101.INS*
101.SCH*
Description of document
Form of Director Agreement by and between the Registrant and certain of its directors, incorporated by
reference to Exhibit 10.9 of the Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as
amended, originally filed with the SEC on June 26, 2019.
Non-Employee Director Compensation Policy, as amended effective January 28, 2021.
Amended and Restated Executive Employment Agreement, dated September 20, 2012, as amended, by and
between the Registrant and Derek J. Maetzold, incorporated by reference to Exhibit 10.10 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June
26, 2019.
Offer Letter Agreement, dated March 2, 2016, by and between the Registrant and Bernhard Spiess, incorporated
by reference to Exhibit 10.12 of the Registrant’s Registration Statement on Form S-1 (File No. 333-232369), as
amended, originally filed with the SEC on June 26, 2019.
Offer Letter Agreement, dated November 9, 2017, by and between the Registrant and Frank Stokes,
incorporated by reference to Exhibit 10.13 of the Registrant’s Registration Statement on Form S-1 (File No.
333-232369), as amended, originally filed with the SEC on June 26, 2019.
Separation Agreement dated May 29, 2020, by and between the Registrant and Federico A. Monzon, M.D.,
incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on
June 2, 2020.
Master Services Agreement dated May 29, 2020, by and between the Registrant and Genomic Path LLC,
incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed with the SEC on
June 2, 2020.
Standard Office Lease, dated as of October 5, 2015, by and between the Registrant and Merced Restart Phoenix
Investors II, LLC, incorporated by reference to Exhibit 10.14 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
First Amendment to Lease, dated December 4, 2018, by and between the Registrant and Alturas Siete I, LLC,
incorporated by reference to Exhibit 10.15 of the Registrant's Annual Report on Form 10-K, filed with the SEC
on March 10, 2020.
Office Building Lease, dated as of March 11, 2015, by and between the Registrant and RMG Leasing (a/k/a
Cedarwood Professional Building), as amended, incorporated by reference to Exhibit 10.15 of the Registrant’s
Registration Statement on Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June
26, 2019.
Standard Office Lease, dated December 16, 2019, by and between the Registrant and Alturas Siete, II, LLC,
incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed with the SEC on
December 19, 2019.
Second Amendment to Standard Office Lease, dated December 16, 2019, by and between the Registrant and
Alturas Siete I, LLC, incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K
filed with the SEC on December 19, 2019.
Commercial Lease, dated December 17, 2019, by and between the Registrant and Tannos Land Holding III,
LLC, incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed with the
SEC on December 19, 2019.
First Amendment to Commercial Lease, dated November 13, 2020, by and between the Registrant and Tannos
Land Holdings III, LLC.
Exclusive License Agreement, dated as of November 14, 2009, by and between the Registrant and The
Washington University, incorporated by reference to Exhibit 10.17 of the Registrant’s Registration Statement on
Form S-1 (File No. 333-232369), as amended, originally filed with the SEC on June 26, 2019.
Consent of KPMG LLP, Independent Registered Public Accounting Firm.
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act.
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act.
Certification of Principal Executive Officer pursuant to Rules 13a-14(b) or 15d-14(b) of the Exchange Act, and
18 U.S.C. Section 1350.
Certification of Principal Financial Officer pursuant to Rules 13a-14(b) or 15d-14(b) of the Exchange Act, and
18 U.S.C. Section 1350.
Inline XBRL Instance Document—the instance document does not appear in the Interactive Data File as its
XBRL tags are embedded within the Inline XBRL document.
Inline XBRL Taxonomy Extension Schema.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase.
92
Exhibit
Number
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase.
Description of document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase.
104*
Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101).
_____________________________________
* Filed herewith
** Furnished herewith.
+
# Certain portions of this exhibit (indicated by “[***]”) have been omitted as we have determined (i) the omitted information
Indicates management contract or compensatory plan.
is not material and (ii) the omitted information would likely cause harm to us if publicly disclosed.
Item 16. Form 10-K Summary.
None.
93
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
CASTLE BIOSCIENCES, INC.
Date: March 11, 2021
By:
/s/ Derek J. Maetzold
Derek J. Maetzold
President and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following
persons on behalf of the Registrant and in the capacity and on the dates indicated.
SIGNATURE
TITLE
DATE
/s/ Derek J. Maetzold
(Derek J. Maetzold)
/s/ Frank Stokes
(Frank Stokes)
/s/ Daniel M. Bradbury
(Daniel M. Bradbury)
/s/ Mara G. Aspinall
(Mara G. Aspinall)
/s/ G. Bradley Cole
(G. Bradley Cole)
/s/ Joseph C. Cook III
(Joseph C. Cook III)
/s/ Miles D. Harrison
(Miles D. Harrison)
/s/ David Kabakoff, Ph.D.
(David Kabakoff, Ph.D.)
President, Chief Executive Officer and Director
March 11, 2021
(Principal Executive Officer)
Chief Financial Officer
March 11, 2021
(Principal Financial and Accounting Officer)
Chairman of the Board of Directors
March 11, 2021
Member of the Board of Directors
March 11, 2021
Member of the Board of Directors
March 11, 2021
Member of the Board of Directors
March 11, 2021
Member of the Board of Directors
March 11, 2021
Member of the Board of Directors
March 11, 2021
94
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Balance Sheets as of December 31, 2020 and 2019
Statements of Operations and Comprehensive (Loss) Income for the Years Ended December 31, 2020
and 2019
Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years Ended
December 31, 2020 and 2019
Statements of Cash Flows for the Years Ended December 31, 2020 and 2019
Notes to Financial Statements
F-2
F-3
F-4
F-5
F-7
F-9
F-1
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
Castle Biosciences, Inc.:
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Castle Biosciences, Inc. (the Company) as of December 31, 2020 and
2019, the related statements of operations and comprehensive (loss) income, convertible preferred stock and stockholders’
equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2020, and the related notes
(collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the
financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for
each of the years in the two-year period ended December 31, 2020, in conformity with U.S. generally accepted accounting
principles.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
these financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to
error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over
financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting
but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis,
evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial
statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2018.
San Diego, California
March 11, 2021
F-2
CASTLE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share and per share data)
ASSETS
Current Assets
Cash and cash equivalents
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Total current assets
Long-term accounts receivable, net
Property and equipment, net
Other assets – long-term
Total assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
Accrued compensation
Medicare advance payment
Other accrued liabilities
Current portion of long-term debt
Total current liabilities
Long-term debt
Noncurrent portion of Medicare advance payment
Deferred rent and other liabilities
Total liabilities
Commitments and Contingencies (Note 10)
Stockholders’ Equity
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of December 31, 2020
and 2019; no shares issued and outstanding as of December 31, 2020 and 2019.
Common stock, $0.001 par value; 200,000,000 authorized as of December 31, 2020 and
2019, respectively; 24,812,487 and 17,130,907 shares issued and outstanding as of
December 31, 2020 and 2019, respectively.
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity
December 31,
2020
2019
$
409,852 $
12,759
2,217
4,766
98,845
14,648
1,237
1,951
429,594
116,681
1,096
7,102
1,536
870
2,060
135
$
439,328 $
119,746
$
2,098 $
9,108
6,615
3,055
—
20,876
—
1,735
1,026
23,637
—
25
1,865
5,779
—
1,812
5,833
15,289
19,289
—
55
34,633
—
17
478,162
(62,496)
415,691
137,308
(52,212)
85,113
$
439,328 $
119,746
The accompanying notes are an integral part of these financial statements.
F-3
CASTLE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
(in thousands, except per share data)
NET REVENUES
COST OF SALES
Gross margin
OPERATING EXPENSES AND OTHER OPERATING INCOME
Research and development
Selling, general and administrative
Other operating income
Total operating expenses, net
Operating (loss) income
Interest income
Interest expense
(Loss) gain on extinguishments of debt
Other expense, net
(Loss) income before income taxes
Income tax expense
Net (loss) income and comprehensive (loss) income
Convertible preferred stock cumulative dividends
Accretion of redeemable convertible preferred stock to redemption value
Net (loss) income and comprehensive (loss) income attributable to common
stockholders
(Loss) earnings per share attributable to common stockholders:
Basic
Diluted
Weighted-average shares outstanding:
Basic
Diluted
Years Ended December 31,
2020
2019
$
62,649 $
9,685
52,964
13,256
48,132
(1,882)
59,506
(6,542)
373
(2,634)
(1,397)
—
(10,200)
84
(10,284)
—
—
51,865
7,310
44,555
7,385
29,842
—
37,227
7,328
312
(4,571)
5,213
(2,933)
5,349
72
5,277
2,156
130
$
(10,284) $
2,991
$
$
(0.54) $
(0.54) $
0.35
(0.21)
18,929
18,929
8,584
8,658
The accompanying notes are an integral part of these financial statements.
F-4
)
T
I
C
I
F
E
D
(
.
C
N
I
,
S
E
C
N
E
I
C
S
O
I
B
E
L
T
S
A
C
)
a
t
a
d
e
r
a
h
s
t
p
e
c
x
e
,
s
d
n
a
s
u
o
h
t
n
i
(
Y
T
I
U
Q
E
’
S
R
E
D
L
O
H
K
C
O
T
S
D
N
A
K
C
O
T
S
D
E
R
R
E
F
E
R
P
E
L
B
I
T
R
E
V
N
O
C
F
O
S
T
N
E
M
E
T
A
T
S
l
a
t
o
T
’
s
r
e
d
l
o
h
k
c
o
t
S
)
t
i
c
i
f
e
D
(
y
t
i
u
q
E
d
e
t
a
l
u
m
u
c
c
A
t
i
c
i
f
e
D
l
a
n
o
i
t
i
d
d
A
n
i
-
d
i
a
P
l
a
t
i
p
a
C
)
6
6
5
,
6
5
(
$
)
9
8
4
,
7
5
(
$
1
2
9
$
—
9
4
2
,
1
5
7
1
,
1
)
2
(
)
7
(
)
1
2
1
(
—
—
8
7
3
,
8
)
5
6
2
,
5
1
(
1
3
9
,
5
6
7
7
5
,
6
2
3
4
7
,
6
4
4
4
7
,
1
7
7
2
,
5
3
1
1
,
5
8
—
9
0
3
,
8
3
9
5
,
1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
9
4
2
,
1
4
7
1
,
1
)
2
(
)
7
(
)
1
2
1
(
—
—
8
7
3
,
8
)
5
6
2
,
5
1
(
6
2
9
,
5
6
6
7
5
,
6
2
5
3
7
,
6
4
—
7
7
2
,
5
—
4
4
7
,
1
$
)
2
1
2
,
2
5
(
$
8
0
3
,
7
3
1
$
—
—
—
—
9
0
3
,
8
2
9
5
,
1
k
c
o
t
S
n
o
m
m
o
C
k
c
o
t
S
d
e
r
r
e
f
e
r
P
e
l
b
a
m
e
e
d
e
R
e
l
b
i
t
r
e
v
n
o
C
k
c
o
t
S
d
e
r
r
e
f
e
r
P
,
1
-
E
,
D
,
B
,
A
s
e
i
r
e
S
F
d
n
a
3
-
E
,
A
2
-
E
,
2
-
E
e
l
b
i
t
r
e
v
n
o
C
d
e
r
r
e
f
e
r
P
C
s
e
i
r
e
S
k
c
o
t
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
2
—
1
—
—
—
—
—
—
—
—
5
1
8
—
—
7
1
—
1
—
$
4
2
2
,
6
1
9
,
1
—
0
4
1
,
3
9
6
8
3
2
,
1
5
—
—
—
—
—
—
—
0
0
0
,
0
0
6
,
4
6
0
1
,
1
6
6
,
1
2
9
9
,
1
8
1
,
8
—
7
0
2
,
7
2
$
7
0
9
,
0
3
1
,
7
1
—
4
7
0
,
9
5
4
2
5
0
,
1
4
2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
$
$
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
5
9
9
,
4
4
$
5
7
7
,
6
5
4
,
9
1
0
5
,
1
$
6
5
0
,
3
0
5
9
1
0
2
,
1
Y
R
A
U
N
A
J
,
E
C
N
A
L
A
B
—
—
—
2
7
1
2
1
7
0
1
0
1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
9
9
9
,
2
1
4
5
0
,
1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
e
l
b
i
t
r
e
v
n
o
c
e
l
b
a
m
e
e
d
e
r
f
o
n
o
i
t
e
r
c
c
A
:
e
u
l
a
v
n
o
i
t
p
m
e
d
e
r
o
t
k
c
o
t
s
d
e
r
r
e
f
e
r
p
e
s
n
e
p
x
e
n
o
i
t
a
s
n
e
p
m
o
c
d
e
s
a
b
-
k
c
o
t
S
s
n
o
i
t
p
o
k
c
o
t
s
n
o
m
m
o
c
f
o
e
s
i
c
r
e
x
E
s
t
n
a
r
r
a
w
k
c
o
t
s
n
o
m
m
o
c
f
o
e
s
i
c
r
e
x
E
1
-
E
s
e
i
r
e
S
3
-
E
s
e
i
r
e
S
F
s
e
i
r
e
S
e
l
b
i
t
r
e
v
n
o
c
e
l
b
a
m
e
e
d
e
r
f
o
:
s
t
n
a
r
r
a
w
k
c
o
t
s
e
s
i
c
r
e
x
E
d
e
r
r
e
f
e
r
p
1
-
E
s
e
i
r
e
S
F
s
e
i
r
e
S
F-5
s
e
t
o
n
y
r
o
s
s
i
m
o
r
p
e
l
b
i
t
r
e
v
n
o
c
n
o
e
r
u
t
a
e
f
n
o
i
s
r
e
v
n
o
c
l
a
i
c
i
f
e
n
e
b
f
o
n
o
i
t
i
n
g
o
c
e
R
s
e
t
o
n
y
r
o
s
s
i
m
o
r
p
e
l
b
i
t
r
e
v
n
o
c
n
o
e
r
u
t
a
e
f
n
o
i
s
r
e
v
n
o
c
l
a
i
c
i
f
e
n
e
b
f
o
t
n
e
m
h
s
i
u
g
n
i
t
x
E
,
k
c
o
t
s
n
o
m
m
o
c
f
o
g
n
i
r
e
f
f
o
c
i
l
b
u
p
l
a
i
t
i
n
I
s
t
s
o
c
g
n
i
r
e
f
f
o
d
n
a
s
n
o
i
s
s
i
m
m
o
c
,
s
t
n
u
o
c
s
i
d
g
n
i
t
i
r
w
r
e
d
n
u
f
o
t
e
n
y
r
o
s
s
i
m
o
r
p
e
l
b
i
t
r
e
v
n
o
c
f
o
n
o
i
s
r
e
v
n
o
C
s
e
t
o
n
)
2
4
2
,
5
4
(
)
8
2
8
,
0
7
4
,
9
(
)
1
0
5
,
1
(
)
6
5
0
,
3
0
5
(
k
c
o
t
s
d
e
r
r
e
f
e
r
p
e
l
b
i
t
r
e
v
n
o
c
f
o
n
o
i
s
r
e
v
n
o
C
—
—
—
—
—
—
$
—
—
—
—
—
—
—
—
—
—
—
—
$
—
—
—
—
—
—
t
n
a
r
r
a
w
k
c
o
t
s
d
e
r
r
e
f
e
r
p
f
o
n
o
i
t
a
c
i
f
i
s
s
a
l
c
e
R
n
i
a
t
r
e
c
f
o
e
s
i
c
r
e
x
e
t
e
n
d
n
a
y
t
i
l
i
b
a
i
l
l
a
i
t
i
n
i
h
t
i
w
n
o
i
t
c
e
n
n
o
c
n
i
s
t
n
a
r
r
a
w
g
n
i
r
e
f
f
o
c
i
l
b
u
p
e
m
o
c
n
i
t
e
N
e
s
n
e
p
x
e
n
o
i
t
a
s
n
e
p
m
o
c
d
e
s
a
b
-
k
c
o
t
S
s
n
o
i
t
p
o
k
c
o
t
s
n
o
m
m
o
c
f
o
e
s
i
c
r
e
x
E
s
t
n
a
r
r
a
w
k
c
o
t
s
n
o
m
m
o
c
f
o
e
s
i
c
r
e
x
E
9
1
0
2
,
1
3
R
E
B
M
E
C
E
D
,
E
C
N
A
L
A
B
.
C
N
I
,
S
E
C
N
E
I
C
S
O
I
B
E
L
T
S
A
C
)
d
e
u
n
i
t
n
o
C
(
)
T
I
C
I
F
E
D
(
Y
T
I
U
Q
E
’
S
R
E
D
L
O
H
K
C
O
T
S
D
N
A
K
C
O
T
S
D
E
R
R
E
F
E
R
P
E
L
B
I
T
R
E
V
N
O
C
F
O
S
T
N
E
M
E
T
A
T
S
)
a
t
a
d
e
r
a
h
s
t
p
e
c
x
e
,
s
d
n
a
s
u
o
h
t
n
i
(
l
a
t
o
T
’
s
r
e
d
l
o
h
k
c
o
t
S
)
t
i
c
i
f
e
D
(
y
t
i
u
q
E
d
e
t
a
l
u
m
u
c
c
A
t
i
c
i
f
e
D
l
a
n
o
i
t
i
d
d
A
n
i
-
d
i
a
P
l
a
t
i
p
a
C
k
c
o
t
S
n
o
m
m
o
C
k
c
o
t
S
d
e
r
r
e
f
e
r
P
e
l
b
a
m
e
e
d
e
R
e
l
b
i
t
r
e
v
n
o
C
k
c
o
t
S
d
e
r
r
e
f
e
r
P
,
1
-
E
,
D
,
B
,
A
s
e
i
r
e
S
F
d
n
a
3
-
E
,
A
2
-
E
,
2
-
E
e
l
b
i
t
r
e
v
n
o
C
d
e
r
r
e
f
e
r
P
C
s
e
i
r
e
S
k
c
o
t
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
t
n
u
o
m
A
s
e
r
a
h
S
4
6
6
,
9
2
3
6
9
2
,
1
)
4
8
2
,
0
1
(
—
—
)
4
8
2
,
0
1
(
—
6
9
2
,
1
7
5
6
,
9
2
3
1
9
6
,
5
1
4
$
)
6
9
4
,
2
6
(
$
2
6
1
,
8
7
4
$
7
—
—
5
2
—
4
5
4
,
1
8
0
0
0
,
0
0
9
,
6
$
7
8
4
,
2
1
8
,
4
2
—
—
—
—
$
—
—
—
—
—
—
—
—
$
—
—
—
—
—
—
—
—
$
—
—
—
—
s
n
o
i
s
s
i
m
m
o
c
,
s
t
n
u
o
c
s
i
d
g
n
i
t
i
r
w
r
e
d
n
u
f
o
t
e
n
,
k
c
o
t
s
n
o
m
m
o
c
f
o
s
g
n
i
r
e
f
f
o
c
i
l
b
u
P
s
t
s
o
c
g
n
i
r
e
f
f
o
d
n
a
e
h
t
r
e
d
n
u
k
c
o
t
s
n
o
m
m
o
c
f
o
e
c
n
a
u
s
s
I
n
a
l
p
e
s
a
h
c
r
u
p
k
c
o
t
s
e
e
y
o
l
p
m
e
0
2
0
2
,
1
3
R
E
B
M
E
C
E
D
,
E
C
N
A
L
A
B
s
s
o
l
t
e
N
.
s
t
n
e
m
e
t
a
t
s
l
a
i
c
n
a
n
i
f
e
s
e
h
t
f
o
t
r
a
p
l
a
r
g
e
t
n
i
n
a
e
r
a
s
e
t
o
n
g
n
i
y
n
a
p
m
o
c
c
a
e
h
T
F-6
CASTLE BIOSCIENCES, INC.
STATEMENTS OF CASH FLOWS
(in thousands)
OPERATING ACTIVITIES
Net (loss) income
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Depreciation
Stock-based compensation expense
Amortization of intangibles
Amortization of debt discounts and issuance costs
Other non-cash interest
Loss (gain) on extinguishments of debt
Change in fair value of preferred stock warrant liability
Change in fair value of embedded derivative
Change in fair value of convertible promissory note accounted for under the fair value
option
Other
Change in operating assets and liabilities:
Accounts receivable
Prepaid expenses and other current assets
Inventory
Other assets
Accounts payable
Accrued compensation
Medicare advance payment
Other accrued liabilities
Deferred rent and other liabilities
Net cash provided by operating activities
INVESTING ACTIVITIES
Purchases of property and equipment
Proceeds from sale of property and equipment
Net cash used in investing activities
FINANCING ACTIVITIES
Proceeds from public offerings of common stock, net of underwriting discounts,
commissions and offering costs
Proceeds from exercise of preferred stock warrants
Proceeds from issuance of convertible promissory notes (including $4,756 from related
parties for the year ended December 31, 2019), net of issuance costs
Proceeds from issuance of convertible promissory note and common stock warrant, net of
issuance costs
Proceeds from issuance of term debt, net of issuance costs
Repayment of term debt
Repayments on line of credit
Proceeds from exercise of common stock options
F-7
Years Ended December 31,
2020
2019
$
(10,284) $
5,277
472
8,309
—
839
—
354
1,249
4
1,925
442
1,397
(5,213)
—
—
—
(16)
1,663
(2,815)
(980)
(1,401)
169
3,329
8,350
561
272
9,865
(4,751)
3
(4,748)
330,041
—
—
—
—
(27,359)
—
1,593
619
237
2,077
—
(896)
(1,276)
(355)
(85)
557
1,208
—
879
12
7,015
(937)
—
(937)
65,931
49
11,695
9,236
1,776
—
(1,791)
1,174
CASTLE BIOSCIENCES, INC.
STATEMENTS OF CASH FLOWS (Continued)
(in thousands)
Proceeds from contributions to the employee stock purchase plan
Net cash provided by financing activities
NET CHANGE IN CASH AND CASH EQUIVALENTS
Beginning of year
End of year
SUPPLEMENTAL DISCLOSURE OF CASH PAID (REFUNDED) FOR:
Interest
Income taxes
DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Accrued purchases of property and equipment
Property and equipment acquired with tenant improvement allowance
Common stock offering costs incurred but not paid
Issuance of common stock upon conversion of convertible preferred stock
Conversion of preferred stock warrants to common stock warrants
Issuance of common stock upon conversion of convertible promissory notes
Cashless exercise of common stock warrants
Years Ended December 31,
2020
2019
1,615
305,890
311,007
98,845
$
409,852 $
218
88,288
94,366
4,479
98,845
$
$
$
$
$
$
$
$
$
1,978 $
102 $
2,206
(150)
58 $
714 $
377 $
— $
— $
— $
250 $
7
—
—
46,743
1,744
26,577
455
The accompanying notes are an integral part of these financial statements.
F-8
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS
1. Organization and Description of Business
Castle Biosciences, Inc. (the ‘‘Company’’) was incorporated in the state of Delaware on September 12, 2007. The Company is
a commercial-stage dermatological cancer company focused on providing physicians and their patients with personalized,
clinically actionable genomic information to make more accurate treatment decisions. The Company is based in Friendswood,
Texas (a suburb of Houston, Texas) and its laboratory operations are conducted at the Company’s facilities located in Phoenix,
Arizona.
Impact of COVID-19 Pandemic
In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019, or COVID-19,
surfaced in Wuhan, China. On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. Since then,
COVID-19 has caused significant disruptions and adverse economic impacts across multiple countries, including the United
States. To date, the Company has maintained uninterrupted business operations with normal turnaround times for its delivery of
test reports. The Company has implemented adjustments to its operations designed to keep employees safe and comply with
federal, state and local guidelines, including those regarding social distancing.
During the second and fourth quarters of 2020, the Company experienced year-over-year declines in test report volume, which
it believes is linked to delays and/or cancellations in patient visits in response to COVID-19, resulting in reduced diagnostic
biopsies and thus reduced diagnoses of cutaneous melanoma. The extent to which COVID-19 may further impact the
Company’s business, results of operations, financial condition and cash flows will depend on future developments, which are
highly uncertain and cannot be predicted with confidence.
In response to COVID-19, the United States government has passed legislation and taken other actions to provide financial
relief to companies and other organizations affected by the pandemic. Refer to Note 2 for information on certain payments
received by the Company in April 2020 as a result of these actions. The Company intends to fund planned operations for the
next 12 months using a portion of its cash and cash equivalents on hand, which totaled $409.9 million at December 31, 2020,
and collections from test report sales.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the
United States of America (‘‘U.S. GAAP’’). The Company has no subsidiaries and all operations are conducted by the
Company.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the
date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant
items subject to such estimates include revenue recognition, the valuation of stock-based compensation, assessing future tax
exposure and the realization of deferred tax assets, the useful lives and recoverability of property and equipment, and contingent
liabilities. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that
the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form
the basis for making judgments about the carrying values of assets and liabilities and recorded revenues and expenses that are
not readily apparent from other sources. Actual results could differ from those estimates and assumptions. The Company has
considered the potential impact of the COVID-19 pandemic on its estimates and assumptions. The extent to which the
COVID-19 pandemic may impact the Company’s estimates in future periods is uncertain and subject to change.
F-9
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Operating Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is
available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to
allocate resources and assess performance. The Company views its operations and manages its business as one operating
segment. All revenues are attributable to U.S.-based operations and all assets are held in the United States.
Cash and Cash Equivalents including Concentrations of Credit Risk
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less. The
Company’s cash equivalents consist of money market funds, which are not insured by the Federal Deposit Insurance
Corporation (“FDIC”), that are primarily invested in short-term U.S. government obligations. Cash deposits at financial
institutions may exceed the amount of insurance provided by the FDIC. Management believes that the Company is not exposed
to significant credit risk on its cash deposits due to the financial position of the institutions in which deposits are held. The
Company has not experienced any losses on its cash or cash equivalents.
Revenue Recognition
Revenue is recognized in accordance with Financial Accounting Standards Board (‘‘FASB’’) Accounting Standards
Codification (‘‘ASC’’) Topic 606, Revenue from Contracts with Customers (‘‘ASC 606’’). In accordance with ASC 606, the
Company follows a five-step process to recognize revenues: (1) identify the contract with the customer, (2) identify the
performance obligations, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations
and (5) recognize revenues when the performance obligations are satisfied.
All of the Company’s revenues from contracts with customers are associated with the provision of diagnostic and prognostic
cancer testing services. Most of the Company’s revenues are attributable to DecisionDx®-Melanoma for cutaneous melanoma.
The Company also provides a test for uveal melanoma, DecisionDx®-UM. The Company launched a test for patients with
cutaneous squamous cell carcinoma, DecisionDx®-SCC in August 2020 and launched a test for use in patients with suspicious
pigmented lesions, DecisionDx® DiffDx™-Melanoma in November 2020. Information on the disaggregation of revenues by
the Company’s significant third-party payors is included under Payor Concentration below. The Company has determined that
it has a contract with the patient when the treating clinician orders the test. The Company’s contracts generally contain a single
performance obligation, which is the delivery of the test report, and the Company satisfies its performance obligation at a point
in time upon the delivery of the test report to the treating clinician, at which point the Company can bill for the report. The
amount of revenue recognized reflects the amount of consideration to which the Company expects to be entitled (the
‘‘transaction price’’) and considers the effects of variable consideration, which is discussed further below.
Once the Company satisfies its performance obligations and bills for the service, the timing of the collection of payments may
vary based on the payment practices of the third-party payor and the existence of contractually established reimbursement rates.
Most of the payments for the Company’s services are made by third-party payors, including Medicare and commercial health
insurance carriers. Certain contracts contain a contractual commitment of a reimbursement rate that differs from the Company’s
list prices. However, absent a contractually committed reimbursement rate with a commercial carrier or governmental program,
the Company’s diagnostic tests may or may not be covered by these entities’ existing reimbursement policies. In addition,
patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the
event that their insurance provider declines to reimburse the Company. The Company may pursue, on a case-by-case basis,
reimbursement from such patients in the form of co-payments and co-insurance, in accordance with the contractual obligations
that the Company has with the insurance carrier or health plan. These situations may result in a delay in the collection of
payments.
The Medicare claims that are covered by policy under a Local Coverage Determination (‘‘LCD’’) are generally paid at the
established rate by the Company’s Medicare contractor within 30 days from receipt. Medicare claims that were either submitted
to Medicare prior to the LCD coverage commencement date or are not covered by the terms of the LCD but meet the definition
of being medically reasonable and necessary pursuant to the controlling Section 1862(a)(1)(A) of the Social Security Act are
generally appealed and may ultimately be paid at the first (termed ‘‘redetermination’’), second (termed ‘‘reconsideration’’) or
third level of appeal (de novo hearing with an Administrative Law Judge (“ALJ”)). A successful appeal at any of these levels
results in payment.
In the absence of LCD coverage or contractually established reimbursement rates, the Company has concluded that its contracts
include variable consideration because the amounts paid by Medicare or commercial health insurance carriers may be paid at
less than the Company’s standard rates or not paid at all, with such differences considered implicit price concessions. Variable
consideration attributable to these price concessions is measured at the expected value using the ‘‘most likely amount’’ method
F-10
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
under ASC 606. The amounts are determined by historical average collection rates by test type and payor category taking into
consideration the range of possible outcomes, the predictive value of the Company’s past experiences, the time period of when
uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of the Company’s
influence, such as the judgment and actions of third parties. Such variable consideration is included in the transaction price only
to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the
uncertainties with respect to the amount are resolved. Variable consideration may be constrained and excluded from the
transaction price in situations where there is no contractually agreed upon reimbursement coverage or in the absence of a
predictable pattern and history of collectability with a payor. Variable consideration for Medicare claims that are not covered by
an LCD, including those claims subject to approval by an ALJ at an appeal hearing, is deemed to be fully constrained due to
factors outside the Company’s influence (i.e., judgment or actions of third parties) and the uncertainty of the amount to be
received is not expected to be resolved for a long period of time. Variable consideration is evaluated each reporting period and
adjustments are recorded as increases or decreases in revenues. Included in revenues for the years ended December 31, 2020
and 2019 were $176,000 and $2,493,000, respectively, of revenue increases associated with changes in estimated variable
consideration related to performance obligations satisfied in previous periods. These amounts include (i) adjustments for actual
collections versus estimated amounts and (ii) cash collections and the related recognition of revenue in current period for tests
delivered in prior periods due to the release of the constraint on variable consideration.
Because the Company’s contracts with customers have an expected duration of one year or less, the Company has elected the
practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs
to obtain contracts are recorded as selling, general and administrative expense as incurred due to the short duration of the
Company’s contracts. Contract balances consisted of accounts receivable (both current and noncurrent) and the Medicare
advance payment (both current and noncurrent, as discussed further below) as of December 31, 2020. Contract balances
consisted solely of accounts receivable (both current and noncurrent) as of December 31, 2019.
Medicare Advance Payment
On April 16, 2020, the Company received an advance payment of $8.3 million (the “Advance Payment”) from the Centers for
Medicare & Medicaid Services (“CMS”) under its Accelerated and Advance Payment Program, which was expanded to provide
increased cash flow to service providers during the COVID-19 pandemic. The Company has recorded the Advance Payment as
a liability, consisting of both a current and noncurrent portion, on its balance sheet as of December 31, 2020. The Company will
reduce the balance of the Advance Payment as it is applied to claims or is otherwise recouped by CMS. Under the Continuing
Appropriations Act, 2021 and Other Extensions Act, enacted on October 1, 2020, the recoupment of the Advance Payment will
commence in April 2021. For the first eleven months of recoupment, CMS will apply 25% of the Medicare payments otherwise
owed to the Company against the balance of the Advance Payment. After that eleven-month period, CMS will recoup at a rate
of 50% of the Medicare payments otherwise owed to the Company for an additional six months. If the Advance Payment is not
fully recovered by CMS after this recoupment period, the Company will be required to repay any remaining balance. The
classification of Advance Payment between current and noncurrent liabilities is based on management’s estimated timing of
recoupment. As of December 31, 2020, no revenue has been recognized related to any portion of the Advance Payment.
DecisionDx-Melanoma Claims Consolidation
In June 2017, the Company submitted to the Office of Medicare Hearings and Appeals (‘‘OMHA’’) a formal request to
participate in a program that OMHA developed with the intent of providing appellants a means to have large volumes of claim
disputes adjudicated at an accelerated rate. The program consolidates outstanding claims at the ALJ level and uses a statistical-
sampling approach where five ALJs will determine reimbursement results for a sample of claims which are then extrapolated to
the universe of claims. The consolidation includes 2,698 DecisionDx-Melanoma claims dating from 2013 through spring 2017.
Hearings were held in April 2019 with a supplemental hearing in May 2019. On March 12, 2020, OMHA issued a decision
denying payment on all claims in the consolidation. The Company has filed an appeal to the decision, although no ruling on
such appeal has been issued to date. In accordance with ASC 606 and consistent with prior periods, the Company has not
recognized (fully constrained the variable consideration) any revenues attributable to these claims in its financial statements
pending the outcome of this matter.
Payor Concentration
The Company relies upon reimbursements from third-party government payors (primarily Medicare) and private-payor
insurance companies to collect accounts receivable related to sales of its diagnostic tests.
F-11
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The Company’s significant third-party payors and their related revenues as a percentage of total revenues and accounts
receivable balances are as follows:
Percentage of Revenues
Percentage of
Accounts Receivable
(current)
Percentage of
Accounts Receivable
(non-current)
Year Ended December 31,
As of December 31,
As of December 31,
2020
2019
2020
2019
2020
2019
58 %
29 %
6 %
49 %
29 %
6 %
15 %
40 %
26 %
7 %
41 %
25 %
— %
25 %
44 %
— %
18 %
46 %
Medicare
Medicare Advantage plans
BlueCross BlueShield plans
Accounts Receivable and Allowance for Doubtful Accounts
The Company classifies accounts receivable balances that are expected to be paid more than one year from the balance sheet
date as non-current assets. The estimated timing of payment utilized as a basis for classification as non-current is determined by
analyses of historical payor-specific payment experience, adjusted for known factors that are expected to change the timing of
future payments.
The Company accrues an allowance for doubtful accounts against its accounts receivable when it is probable that an account is
not collectible, based on write off history, credit risk of specific accounts, aging analysis and other information available on
specific accounts. The Company generally does not perform evaluations of customers’ financial condition and generally does
not require collateral. Accounts receivable are written off when all efforts to collect the balance have been exhausted.
Historically, the Company’s bad debt expense has not been significant. The allowance for doubtful accounts was zero as of
December 31, 2020 and 2019. Adjustments for implicit price concessions attributable to variable consideration, as discussed
above, are incorporated into the measurement of the accounts receivable balances and are not part of the allowance for doubtful
accounts.
Inventory
The Company carries an inventory of test supplies in the Phoenix, Arizona laboratory. The inventory is carried at the lower of
weighted average cost and net realizable value and expensed through cost of sales as the supplies are used.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the
straight-line method over the estimated useful lives of the assets, generally between five and ten years. Leasehold improvements
are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease.
The Company’s leasehold improvements primarily relate to its office and laboratory facilities in Phoenix, Arizona, and are
generally being amortized through the end of the lease terms of July 2027 and March 2028. Maintenance and repairs are
charged to expense as incurred, and material improvements are capitalized. When assets are retired or otherwise disposed of,
the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the
statements of operations and comprehensive (loss) income in the period realized.
Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying
amount of the assets may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted
cash flows, expected to result from the use of the asset and its eventual disposition, are less than the carrying amount.
Impairment, if any, would be calculated based on the excess of the carrying amount of the long-lived asset over the long-lived
asset’s fair value. There were no impairment charges recognized for the years ended December 31, 2020 and 2019.
Other Operating Income
On April 10, 2020, the Company received an automatic payment of $1.9 million from the U.S. Department of Health and
Human Services (“HHS”) pursuant to the Coronavirus Aid, Relief and Economic Security Act enacted on March 27, 2020, also
known as the CARES Act, out of relief funds allocated by HHS to healthcare providers to reimburse healthcare related
expenses or lost revenues attributable to COVID-19. This automatic payment was calculated by HHS in proportion to the
providers’ share of Medicare fee-for-service reimbursements in 2019 and was applicable to all facilities and providers that
received Medicare fee-for-service reimbursements in 2019. In the second quarter of 2020, based on guidance issued by HHS at
F-12
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
the time that stated any reasonable method could be used to calculate lost revenues attributable to COVID-19, the Company
concluded it would qualify to retain the relief funds and recognized the funds received as other operating income during the
three months ended June 30, 2020. On September 19, 2020, HHS issued a notice of reporting requirements that changed the
methodology for determining lost revenues to be based on a patient care operating income metric, as defined by HHS. Due to
this change in methodology and uncertainty in its application, the Company determined that it was no longer reasonably assured
of keeping the funds. Therefore, in the three months ended September 30, 2020, the Company reversed the previously
recognized income. On October 22, 2020, HHS again revised the methodology for calculating lost revenues, with such changes
defining lost revenues as a negative change, if any, in calendar year 2020 revenues compared to calendar year 2019 revenues.
Based on these developments, the Company issued a check to repay the funds in December 2020. However, on December 27,
2020, the Coronavirus Response and Relief Supplemental Appropriations Act, 2021 was signed into law, which among other
things included a provision amending the provider relief funds lost revenue calculation to be consistent with HHS’s June 2020
guidance, including allowing lost revenues to be determined by comparing actual 2020 revenues to 2020 budgeted revenues,
subject to certain conditions, which was incorporated into revised HHS reporting requirements issued in January 2021. Given
this development, subsequent to December 31, 2020, the Company notified HHS of its intention to keep the funds and canceled
the repayment. Based on the changes to the requirements enacted on December 27, 2020 the Company determined that it is
reasonably assured of keeping the funds and therefore recognized the $1.9 million as other operating income during the three
months ended December 31, 2020.
Fair Value of Financial Instruments
As of December 31, 2019, the carrying amount of the Company’s long-term debt approximated fair value due to its variable
market interest rate and management’s opinion that then-current rates and terms that would have been available to the Company
with the same maturity and security structure would have been essentially equivalent to that of the Company’s long-term debt.
This estimated fair value was a ‘‘Level 3’’ fair value measurement as defined in Note 9.
Deferred Rent
The Company has negotiated certain landlord/tenant incentives, rent holidays and escalations in the base price of rent payments
under operating leases. The Company recognizes these incentives, rent holidays and rent escalations on a straight-line basis
over the lease term. Deferred rent balances are classified as current or non-current in the accompanying balance sheets based
upon the period when reversal of the liability is expected to occur.
Cost of Sales
Cost of sales is expensed as incurred and includes direct labor costs, equipment, supplies, materials and infrastructure expenses
associated with testing tissue samples, third-party lab processing and service costs, third-party collection costs, and shipping
charges to transport samples.
Research and Development
Research and development costs are charged to operations as incurred. Advance payments for goods and services that will be
used in future research and development activities are expensed when the activity has been performed or when the goods have
been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research
and development services on behalf of the Company will be expensed as services are rendered or when the milestone is
achieved.
Research and development costs include, but are not limited to, payroll and personnel-related expenses, stock-based
compensation expense, materials, laboratory supplies, and consulting costs.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”) expenses are attributable to sales, marketing, executive, finance and accounting,
legal and human resources functions. These expenses consist of personnel costs (including salaries, employee benefit costs,
bonuses and equity-based compensation expenses), customer services expenses, direct marketing expenses, educational and
promotional expenses, market research, audit and legal expenses, and consulting. The Company expenses all SG&A costs as
incurred.
Accrued Compensation
The Company accrues for liabilities under discretionary employee and executive bonus plans. These estimated compensation
liabilities are based on progress against corporate objectives approved by the Company’s board of directors, compensation
levels of eligible individuals, and target bonus percentage levels. The board of directors reviews and evaluates the performance
F-13
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
against these objectives and ultimately determines what discretionary payments are made. The Company also accrues for
liabilities under employee sales incentive bonus plans with accruals based on performance achieved to date compared to
established targets. As of December 31, 2020 and 2019, the Company accrued approximately $7,175,000 and $4,785,000,
respectively, for liabilities associated with these bonus plans. These amounts are classified as current or noncurrent accrued
liabilities in the balance sheets based on the expected timing of payment.
Retirement Plan
The Company has an Internal Revenue Code (“IRC”) Section 401(k) profit sharing plan (the “Plan”) for eligible employees.
The Plan is funded by employee contributions and provides for discretionary contributions in the form of matching and/or
profit-sharing contributions. For the years ended December 31, 2020 and 2019, the Company provided a discretionary matching
contribution of $789,000 and $434,000, respectively.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and
liabilities are measured using statutory tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is
recognized in the period that includes the statutory enactment date. Valuation allowances are established to reduce deferred tax
assets when it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax
authorities. The amount recognized is measured as the largest amount of benefit that is greater than 50% likely to be realized
upon settlement. A liability for unrecognized tax benefits is recorded for any tax benefits claimed in the Company’s tax returns
that do not meet these recognition and measurement standards.
The Company’s policy for recording interest and penalties associated with uncertain tax positions is to record such items as a
component of tax expense. No material amounts of tax-related interest or penalties were recorded during the years ended
December 31, 2020 and 2019.
Stock-Based Compensation
Stock-based compensation expense for equity instruments issued to employees is measured based on the grant-date fair value of
the awards. The fair value of employee stock options and offerings under the 2019 Employee Stock Purchase Plan (the “ESPP”)
are estimated on the date of grant using the Black-Scholes option-pricing valuation model. For restricted stock units (“RSUs”),
the fair value is equal to the closing price of the Company’s common stock on the date of grant. The Company recognizes
compensation costs on a straight-line basis for all employee stock-based compensation awards over the requisite service period
of the awards. For options and RSUs, the requisite service period is generally the awards’ vesting period (typically four years).
For the ESPP, the requisite service period is generally the period of time from the offering date to the purchase date. Forfeitures
are accounted for as they occur.
Comprehensive (Loss) Income
Comprehensive (loss) income is defined as a change in equity during a period from transactions and other events and
circumstances from non-owner sources. The Company’s comprehensive (loss) income was the same as its reported net (loss)
for all periods presented.
CARES Act Payroll Tax Deferral
The CARES Act permits employers to defer the payment of the employer share of social security taxes due for the period
beginning March 27, 2020 and ending December 31, 2020. Of the amounts deferred, 50% are required to be paid by December
31, 2021 and the remaining 50% are required to be paid by December 31, 2022. The Company began deferring payment of the
employer share of social security taxes in May 2020. As of December 31, 2020, the Company had deferred payment of
$551,000 of such taxes, which are allocated between current and noncurrent liabilities on the balance sheet.
Accounting Pronouncements Yet to be Adopted
In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU
2016-02”), which supersedes FASB ASC Topic 840, Leases, and provides principles for the recognition, measurement,
presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach,
classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed
purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest
F-14
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
method for finance leases or on a straight-line basis over the term of the lease for operating leases. A lessee is also required to
record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of classification.
Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. For companies
that are not emerging growth companies (‘‘EGCs’’), ASU 2016-02 is effective for fiscal years beginning after December 15,
2018. For EGCs, the ASU was to be effective for fiscal years beginning after December 15, 2019. However, in November 2019,
the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and
Leases (Topic 842): Effective Dates (“ASU 2019-10”), which included a one-year deferral of the effective date of ASU 2016-02
for certain entities. In June 2020, the FASB issued ASU No. 2020-05, Revenue from Contracts with Customers (Topic 606) and
Leases (Topic 842): Effective Dates for Certain Entities, which further defers the effective date for certain entities. As a result,
the ASU is now effective for EGCs for fiscal years beginning after December 15, 2021, and interim periods within fiscal years
beginning after December 15, 2022. If Company maintains EGC status, it will adopt the new standard in the fourth quarter of
2022 using the modified retrospective method, under which the Company will apply Topic 842 to existing and new leases as of
January 1, 2022, but prior periods will not be restated and will continue to be reported under Topic 840 guidance in effect
during those periods. The Company anticipates that the adoption will not have a material impact on its statements of operations
and comprehensive (loss) income or its statements of cash flows but expects to recognize right-of-use assets and liabilities for
lease obligations associated with its operating leases.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (“ASU 2016-13”), which requires the
measurement of expected credit losses for financial instruments carried at amortized cost, such as accounts receivable, held at
the reporting date based on historical experience, current conditions and reasonable forecasts. The main objective of this ASU is
to provide financial statement users with more decision-useful information about the expected credit losses on financial
instruments and other commitments to extend credit held by a reporting entity at each reporting date. In November 2018, the
FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financing Instruments—Credit Losses, which
included an amendment of the effective date for nonpublic entities. For non-EGCs, ASU 2016-13 is effective for fiscal years
beginning after December 15, 2019. For EGCs, the standard was to be effective for fiscal years beginning after December 15,
2021. However, in November 2019, the FASB issued ASU 2019-10, which included a one-year deferral of the effective date of
ASU 2016-13 for certain entities. As a result, ASU is now effective for EGCs for fiscal years beginning after December 15,
2022, including interim periods within those fiscal years. The Company does not currently believe the adoption of this standard
will have a significant impact on its financial statements, given its history of minimal bad debt expense relating to trade
accounts receivable.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income
Taxes (“ASU 2019-12”), which eliminates certain exceptions to the general principles in Topic 740 and simplifies other areas
of the existing guidance. For non-EGCs, ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and
interim periods within those fiscal years. For EGCs, the standard is effective for fiscal years beginning after December 15,
2021, and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company is
currently evaluating the impact of ASU 2019-12 on its financial statements.
If the market value of the Company’s common stock held by non-affiliates exceeds $700.0 million as of June 30, 2021, the
Company will cease to be an emerging growth company effective December 31, 2021. If that occurs, the Company will be
required to apply the non-EGC effective dates in adopting accounting pronouncements that qualify for delayed adoption by
EGCs, including the accounting pronouncements discussed above.
3. (Loss) Earnings Per Share
Basic (loss) earnings per share is computed by dividing net (loss) income attributable to common stockholders for the period by
the weighted-average number of common shares outstanding during the period. The weighted-average number of common
shares outstanding includes shares associated with a warrant, issued in July 2019, to purchase 209,243 shares of common stock,
which were deemed to have been issued for purposes of calculating basic and diluted (loss) earnings per share, due to the
nominal exercise price. On July 29, 2019, the Company completed the initial public offering of its common stock (“IPO”), in
which it issued and sold 4,600,000 shares of common stock. Also on that date, all of the Company’s outstanding convertible
preferred stock and convertible promissory notes automatically converted into 8,181,992 and 1,661,106 shares, respectively, of
common stock and certain outstanding warrants to purchase Series F convertible redeemable preferred stock were net exercised
for an aggregate of 27,207 shares of common stock. On June 29, 2020, July 2, 2020 and December 18, 2020, the Company
issued and sold 2,000,000 shares, 300,000 shares and 4,600,000, respectively, of common stock in follow-on public offerings,
as discussed further in Note 12. The foregoing shares are included in the Company’s weighted-average number of common
shares outstanding starting on the respective issuance/conversion dates.
F-15
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Diluted (loss) earnings per share reflects the additional dilution from potential issuances of common stock, such as stock
issuable pursuant to the exercise of stock options, the vesting of RSUs or purchases under the ESPP, as well as from the
assumed conversion/exercise of the Company’s convertible preferred stock, convertible promissory notes and outstanding
warrants. The treasury stock and if-converted methods are used to calculate the potential dilutive effect of these common stock
equivalents. However, potentially dilutive shares are excluded from the computation of diluted (loss) earnings per share when
their effect is antidilutive.
The following table shows the computation of basic and diluted (loss) earnings per share for the years ended December 31,
2020 and 2019 (in thousands, except per share data):
Numerator:
Net (loss) income attributable to common stockholders
Assumed conversion of convertible promissory notes(1):
Subtract: Extinguishment gain
Add: Interest expense and change in fair value of embedded derivative
Numerator for diluted loss per share
Denominator:
Weighted-average common shares outstanding, basic
Assumed conversion of convertible promissory notes(1)
Weighted-average common shares outstanding, diluted
(Loss) earnings per share attributable to common stockholders:
Basic
Diluted
Years Ended December 31,
2020
2019
$
(10,284) $
2,991
—
—
(5,213)
420
$
(10,284) $
(1,802)
18,929
—
18,929
8,584
74
8,658
$
$
(0.54) $
(0.54) $
0.35
(0.21)
(1) For the year ended December 31, 2019, this figure reflects the assumed conversion of the Q1 2019 Notes (as defined in Note 6) into shares of common
stock beginning July 1, 2019, in accordance with the requirements in ASC Topic 260, Earnings per Share, for contingently issuable shares due to the
contingency not being met until the third quarter of 2019. The July 2019 Note (as defined in Note 6), was excluded from the computation of diluted
earnings (loss) per share prior to its conversion on July 29, 2019 in connection with the IPO, as disclosed below.
Due to the Company reporting a net loss attributable to common stockholders for the year ended December 31, 2020, all
potentially dilutive securities are antidilutive and are excluded from the computations of diluted loss per share. For the year
ended December 31, 2019, the computation of diluted loss per share excludes the assumed conversions of the convertible
preferred stock, assumed conversion of the July 2019 Note (in each case, for the time prior to their actual conversions),
assumed exercise of all stock options, assumed issuance of shares under the ESPP and the assumed exercise of all common
stock warrants because to include them would be antidilutive.
F-16
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The table below provides the weighted-average number of potential common shares associated with outstanding securities not
included in the Company’s calculation of diluted (loss) earnings per share for the years ended December 31, 2020 and 2019
because to do so would be antidilutive (in thousands):
Convertible preferred stock
Convertible promissory note(1)
Stock options and restricted stock units
Common stock warrants
Preferred stock warrants
Employee stock purchase plan
Total
(1) Associated with the July 2019 Note.
4. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
Lab equipment
Computer equipment
Leasehold improvements
Furniture and fixtures
Construction-in-progress
Total
Less accumulated depreciation
Property and equipment, net
Years Ended December 31,
2020
2019
—
—
2,789
35
—
100
2,924
4,679
33
1,820
41
80
24
6,677
As of December 31,
2020
2019
$
2,037 $
1,563
1,305
1,388
436
3,590
8,756
(1,654)
7,102 $
$
887
635
176
2
3,263
(1,203)
2,060
Depreciation expense was recorded in the statements of operations and comprehensive (loss) income as follows (in thousands):
Cost of sales
Research and development
Selling, general and administrative
Total
Years Ended December 31,
2020
2019
$
$
341 $
31
100
472 $
277
7
70
354
F-17
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
5. Other Accrued Liabilities
Other accrued liabilities consisted of the following (in thousands):
Accrued service fees
Employee stock purchase plan contributions
Deferred employer payroll tax liability
Accrued royalties
Accrued state taxes
Accrued interest
Other
Total
6. Convertible Promissory Notes
Q1 2019 Notes
As of December 31,
2020
2019
$
1,891 $
1,162
536
276
151
62
—
139
218
—
169
79
184
—
$
3,055 $
1,812
In January and February 2019, the Company issued $11,770,000 principal amount of unsecured convertible promissory notes
(the “Q1 2019 Notes”), of which $4,756,000 was with related parties (executive officers, members of the Company’s Board of
Directors or entities affiliated with them). The Q1 2019 Notes bore simple interest at a rate of 8% per annum. Originally, the Q1
2019 Notes had a maturity date of January 31, 2020, but on July 3, 2019, the Company entered into an amendment with the
holders of the Q1 2019 Notes to extend the maturity to June 30, 2020. Such amendment was treated as a modification of the
existing debt and therefore no extinguishment gain or loss was recognized in connection with the amendment.
Prior to the actual conversion of the Q1 2019 Notes on July 29, 2019 (discussed below), on or before the maturity date, the
entire outstanding principal amount of and accrued interest on the Q1 2019 Notes (the “Conversion Amount”), was
automatically convertible into shares of the Company’s equity securities issued and sold in a single or series of related
transactions, with the principal purpose of raising capital, in which the Company sold shares of such equity securities for
aggregate gross proceeds of at least $10.0 million (the “Next Equity Financing”). The number of shares of such equity
securities issuable in the Next Equity Financing was equal to the quotient of the Conversion Amount as of the closing date of
the Next Equity Financing divided by a per share price that is equal to 80% of the lowest per share purchase price of the equity
securities sold in the Next Equity Financing. If the Q1 2019 Notes had not been repaid or converted prior to the maturity date,
then, at the request of the holders of a majority of the then-outstanding principal amount of and accrued interest on the Q1 2019
Notes, the Conversion Amount as of the maturity date would have converted into shares of the Company’s Series F redeemable
convertible preferred stock, or any senior equity security issued by the Company after the first issuance of the Q1 2019 Notes,
in each case at a conversion price equal to the price at which such security was last sold (which was $5.8208 for shares of the
Company’s Series F redeemable convertible preferred stock). If a change of control of the Company would have occurred while
the Q1 2019 Notes were outstanding, the Company would have been required to repurchase each note from each holder at a
repurchase price equal to two times the principal amount of such Note, plus any accrued and unpaid interest on such note as of
the date of such repurchase.
The Company determined that the Q1 2019 Notes contained embedded derivatives that required bifurcation and separate
accounting under ASC 815-15, Embedded Derivatives. The Company determined that two such features in the Q1 2019 Notes
were not considered clearly and closely related to the host debt instrument and therefore required separate accounting: (i) the
automatic conversion feature in connection with the Next Equity Financing and (ii) the acceleration upon a change of control
feature. Under ASC 815-15, these features are bundled together and accounted for as a single, compound embedded derivative.
The Company determined the fair value of the embedded derivative liability at the issuance date, creating a discount to the
carrying value of the Q1 2019 Notes, which was being amortized over the life of the debt using the effective interest method.
The embedded derivative was recorded at fair value each reporting period, with changes in fair value recorded as “other
expense, net” in the statements of operations and comprehensive (loss) income. No hedge accounting treatment was applied.
For details regarding the fair value measurement of the embedded derivative, see Note 9.
The Company also assessed the optional conversion feature into Series F redeemable convertible preferred stock at maturity and
determined that this feature did not meet the definition of a derivative instrument because the settlement terms involved the
gross delivery of the underlying shares, which were not readily convertible to cash. The Company then assessed whether this
F-18
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
feature caused the Q1 2019 Notes to be subject to ASC 470-20, Debt with Conversion and Other Options (“ASC 470-20”), and
determined that the beneficial conversion feature guidance was applicable to the Q1 2019 Notes. At issuance, the Company
concluded that the Q1 2019 Notes had a beneficial conversion feature because the fair value of the Series F preferred stock
exceeded the conversion price of $5.8208 per share that would have been applicable under the optional conversion at maturity,
assuming no other equity securities senior to Series F preferred stock were sold. Under ASC 470-20, this beneficial conversion
feature was measured at intrinsic value as of the issuance date of the Q1 2019 Notes and was recognized as additional paid-in
capital, creating a discount to the carrying value of the Q1 2019 Notes that was being amortized over the life of the debt using
the effective interest method.
The closing of the IPO on July 29, 2019 was considered to be the Next Equity Financing under the terms of the Q1 2019 Notes.
Accordingly, on July 29, 2019, the Conversion Amount of the Q1 2019 Notes as of such date converted into 954,074 shares of
common stock based on a price of $12.80 per share, or 80% of the IPO price of $16.00 per share. The conversion of the Q1
2019 Notes was considered an extinguishment for accounting purposes. The Company recognized an extinguishment gain of
$5,213,000 in connection with the conversion with extinguishment consideration measured at $15,265,000, which is calculated
as the number of shares issued upon conversion multiplied by the IPO price of $16.00 per share. All of this consideration was
allocated to additional paid-in capital to redeem the beneficial conversion feature.
The following table summarizes the aggregate values recorded for the Q1 2019 Notes as of their original issuance dates. As
noted above, the Q1 2019 Notes were converted into shares of common stock in connection with the closing of the IPO on July
29, 2019 (in thousands).
Liability component:
Principal (including $4,756 with related parties)
Unamortized issuance costs
Unamortized discount from beneficial conversion feature
Unamortized discount from embedded derivative
Net carrying amount of the liability component
Embedded derivative liability
Equity Component:
Carrying value of beneficial conversion feature recorded in additional paid-in capital
At Original
Issuance (1)
$
$
$
$
11,770
(75)
(8,378)
(2,816)
501
2,816
8,378
(1) The Q1 2019 Notes were issued on January 31, 2019, February 12, 2019 and February 27, 2019.
Amortization of discounts and issuance costs on the Q1 2019 Notes totaled $1,216,000 for the year ended December 31, 2019,
and were included in interest expense.
The amounts recognized in net income for the year ended December 31, 2019 for the embedded derivative liability are as
follows (in thousands):
(Loss) Recognized in Net
Income
Statement of Operations
and Comprehensive
(Loss) Income Location
Year Ended
December 31, 2019
Derivatives Not Classified as Hedging Instruments
Embedded derivative in convertible promissory notes
Other expense, net
$
(237)
July 2019 Note
On July 12, 2019, the Company issued an unsecured convertible promissory note having a principal amount of $10,000,000 (the
‘‘July 2019 Note’’) to an investor. The July 2019 Note bore simple interest at a rate of 8% per annum and had an original
maturity date of June 30, 2020. The IPO triggered an automatic conversion feature of the July 2019 Note under which the
outstanding principal amount plus accrued interest converted into 707,032 shares of common stock in connection with the
F-19
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
closing of the IPO on July 29, 2019, based on a price derived from a valuation calculated pursuant to the terms of the July 2019
Note. In connection with the July 2019 Note issuance, the Company issued the purchaser of the July 2019 Note a warrant to
purchase up to 209,243 shares of common stock at an exercise price of approximately $0.001 per share (the “July 2019
Warrant”).
The Company elected to account for the July 2019 Note under the fair value option in accordance with ASC 825, Financial
Instruments. Absent the election of the fair value option, there were several embedded features of the July 2019 Note which
would have required separate accounting as an embedded derivative. Given the complexity of these features and the short time
period the July 2019 Note was actually outstanding, the Company elected the fair value option to simplify the accounting for
the July 2019 Note. Under the fair value option, changes in fair value are recorded in the statements of operations and
comprehensive (loss) income each period as “Other expense, net.”
The Company received $10,000,000 from the purchaser and incurred $764,000 in issuance costs, resulting in net proceeds of
$9,236,000. The Company subsequently adjusted the fair value of the July 2019 Note to its conversion date fair value of
$11,313,000, which was calculated as the number of common shares into which the July 2019 Note became actually convertible
in connection with the IPO multiplied by the IPO price of $16.00 per share. No portion of the change in fair value was deemed
to be associated with changes in instrument-specific credit risk, due to the short period of time the July 2019 Note was
outstanding. Interest expense and the issuance costs associated with the July 2019 Note were included as part of the change in
fair value recorded in “Other expense, net.” Because the initial fair value of the July 2019 Note exceeded the proceeds received,
the Company did not allocate any portion of the proceeds to the July 2019 Warrant.
7. Long-Term Debt
The Company’s long-term debt balances are presented in the table below (in thousands):
Term debt
Unamortized discount and issuance costs
Total long-term debt
Less: Current portion of long-term debt
Total long-term debt, less current portion
As of December 31,
2020
2019
$
$
— $
—
—
—
— $
26,688
(1,566)
25,122
(5,833)
19,289
On November 30, 2018, the Company entered into a Loan and Security Agreement (the ‘‘2018 LSA’’), with Oxford Finance
LLC (‘‘Oxford’’), as collateral agent, and Oxford and Silicon Valley Bank as equal syndicated lenders. The 2018 LSA provided
for a $20.0 million secured term loan credit facility (the ‘‘Term Loan’’) and a credit line of up to $5.0 million, prior to
amendment of the 2018 LSA on June 13, 2019, as discussed below. The Company’s obligations under the 2018 LSA were
secured by substantially all of its assets, excluding intellectual property and subject to certain other exceptions and limitations.
In addition, the 2018 LSA contained customary conditions of borrowing, events of default and covenants.
On June 13, 2019, the Company entered into an amendment to the 2018 LSA (the “First Amendment”), which, among other
things eliminated the $5.0 million revolving line and increased the Term Loan by $5.0 million and amended a financial
covenant requiring the Company to achieve certain revenue targets. The First Amendment was accounted for as a modification
of the 2018 LSA, and therefore no extinguishment gain or loss was recognized.
The Term Loan bore interest, payable monthly in arrears, at a floating rate equal to the greater of (1) 8.55% and (2) the 30-day
U.S. LIBOR rate as reported in the Wall Street Journal on the last business day of the month that precedes the month in which
the interest will accrue, plus 6.48%. The applicable interest rate on the Term Loan was 8.55% at December 31, 2019. The
Company was permitted to make interest-only payments on the Term Loan for the 18 months through May 31, 2020. As
required, the Company began to repay the term loan in 30 equal monthly installments beginning on June 1, 2020. All unpaid
principal and accrued and unpaid interest were to be due on November 1, 2022 (the “Term Loan Maturity Date”). Additionally,
the Company was obligated to make an additional final payment of 6.75% of the aggregate original principal amount, or
$1,687,500, upon any prepayment or on the Term Loan Maturity Date. The final payment amount was being amortized as
additional interest expense using the effective interest method over the term of the debt.
On December 21, 2020, the Company terminated the 2018 LSA and repaid in full all amounts due, which totaled $21.6 million,
including the outstanding principal balance, the final payment amount, early termination and prepayment fees and accrued
interest. The Company recognized a loss of $1.4 million in connection with the extinguishment of the 2018 LSA, which was
F-20
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
attributable to the write off of the unamortized discount and issuance costs of $0.7 million, the early termination fee of
$0.5 million and prepayment fees of $0.2 million.
8. Operating Leases
In December 2019, the Company entered into an agreement to lease office space in Friendswood, Texas (the “Friendswood
Lease”) to serve as its new headquarters. The Friendswood Lease commenced in December 2020 and has a 60-month term,
with an option to renew for one additional five-year period. In addition, the Company leases another facility for office space in
Friendswood, Texas on a month-to-month basis.
The Company leases two facilities for office and laboratory space in Phoenix, Arizona. The Company took occupancy of the
original facility in April 2016. Pursuant to an amendment in December 2019, the lease term was extended to July 31, 2027.
Also in December 2019, the Company entered into a lease of the second facility for clinical and research laboratory purposes as
well as general office use. This lease commenced in September 2020 and extends through March 31, 2028. Each of the leases
provide the Company with an option to extend their respective term for two additional renewal periods of five years each.
Other leasing arrangements include office equipment and a corporate apartment.
All leases have been classified as operating leases. Rent expense is recognized on a straight-line basis over the term of the
leases.
Future non-cancellable commitments under all operating leases are as follows (in thousands):
Years Ending December 31,
2021
2022
2023
2024
2025
Thereafter
$
$
1,164
1,148
1,142
1,154
1,119
1,037
6,764
Rent expense was $548,000 and $395,000 for the years ended December 31, 2020 and 2019, respectively.
9. Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market in an orderly transaction between market participants at the measurement date. The fair
value hierarchy prioritizes the inputs to valuation techniques used in measuring fair value. There are three levels to the fair
value hierarchy based on the reliability of inputs, as follows:
Level 1 – Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 – Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or
indirectly.
Level 3 – Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own
assumptions.
Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant
to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value
measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The
use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly,
the fair value estimates disclosed, or amounts recorded may not be indicative of the amount that the Company or holders of the
instruments could realize in a current market exchange.
F-21
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The table below provides information (in thousands), by level within the fair value hierarchy, of the Company’s financial assets
and liabilities that are accounted for at fair value on a recurring basis as of December 31, 2020 and 2019 in thousands):
As of December 31, 2020
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
$
409,480 $
— $
— $
409,480
As of December 31, 2019
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
$
98,389 $
— $
— $
98,389
Assets:
Money market funds(1)
Assets:
Money market funds(1)
(1) Classified as “Cash and cash equivalents” in the balance sheets.
There were no Level 3 fair value measurements as of December 31, 2020 and 2019. The following table discloses the summary
of changes in the fair value of the Level 3 fair value measurements during the year ended December 31, 2019 (in thousands):
Balance, January 1, 2019
Issuance of convertible promissory notes
Change in fair value included in net income
Preferred
stock
warrant
liability
Embedded
derivative
liability in
the Q1 2019
Notes
$
1,194 $
— $
—
619
2,816
237
The
July 2019
Note
—
9,236
2,077
Extinguishment of convertible promissory notes and exercise of warrants
(68)
(3,053)
(11,313)
Reclassification of preferred stock warrant liability to stockholders’ equity
(1,745)
Balance, December 31, 2019
$
— $
—
— $
—
—
The changes in fair value of the preferred stock warrant liability, the embedded derivative liability and the July 2019 Note were
recorded as ‘‘Other expense, net’’ in the statements of operations and comprehensive (loss) income.
The fair value of the warrants to purchase shares of redeemable convertible preferred stock was estimated by management using
the Black-Scholes option pricing model. In connection with the IPO, all outstanding preferred stock warrants became
exercisable for shares of common stock. The Company recorded a final fair value adjustment on the preferred stock warrant
liability as of immediately prior to the closing of the IPO based on the IPO price of $16.00 per share. The preferred stock
warrant liability was then reclassified to stockholders’ equity and no additional fair value adjustments were subsequently
recorded.
Certain features of the Q1 2019 Notes were determined to be an embedded derivative requiring bifurcation and separate
accounting, as discussed in Note 6. The fair value of the embedded derivative was determined based on a probability-weighted
income approach discounted at an interest rate that was consistent with the appropriate market interest rate (ranging from 8.93%
to 11.40%) considering management’s estimates of the probability of the possible settlement outcomes. At inception of the Q1
2019 Notes, management assessed the probability of the occurrence of the Next Equity Financing at 90%. The final fair value
adjustment was based upon the actual settlement of the Q1 2019 Notes in connection with the IPO.
F-22
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
The Company elected the fair value option for the July 2019 Note, as discussed in Note 6. The change in fair value recorded for
the July 2019 Note represents the difference between the net proceeds received and the fair value of the shares issued upon
conversion of the July 2019 Note in connection with the IPO, valued at the IPO price of $16.00 per share.
10. Commitments and Contingencies
From time to time, the Company may be involved in legal proceedings arising in the ordinary course of business. The Company
believes there is no threatened litigation or litigation pending that could have, individually or in the aggregate, a material
adverse effect on the Company’s financial position, results of operations or cash flows.
11. Convertible Preferred Stock and Preferred Stock Warrants
Convertible Preferred Stock
In connection with the IPO, on July 29, 2019, all outstanding shares of the Company’s convertible preferred stock automatically
converted into shares of common stock at a rate of one common share for each 1.219 shares of convertible preferred stock. The
Company’s convertible preferred stock was classified outside of stockholders’ equity in accordance with authoritative guidance
for the classification and measurement of potentially redeemable securities. The preferred stock was contingently redeemable
upon events that are outside of the Company’s control including liquidation, sale, or transfer of control of the Company. The
Company had determined not to adjust the carrying values of the convertible preferred stock to liquidation preferences of such
shares because of the uncertainty of whether or when such events would occur. Further, except for Series C preferred stock, the
preferred stock was redeemable upon the majority vote of specified holders of the preferred stock.
As a result of a 1-for-1.219 reverse stock split effected on July 11, 2019, the conversion price for each series of preferred stock
was adjusted to be the original issue price multiplied by 1.219. Immediately prior to the closing of the IPO, 9,973,884 shares of
outstanding convertible preferred stock were automatically converted into 8,181,992 shares of common stock. In connection
with the conversion, the Company derecognized the convertible preferred stock at their carrying values and allocated such
amounts to common stock and additional paid-in capital effective July 29, 2019.
Any discount to the original issue price was being accreted with a charge to additional paid-in capital over the period through
the earliest date the redeemable convertible preferred stock could become redeemable. Any unpaid cumulative accruing
dividends would have been payable upon a liquidation event or a deemed liquidation event, but were not recorded in the
financial statements since such events did not become probable of occurring.
Preferred Stock Warrant Liabilities
The Company previously issued warrants to purchase shares of its convertible preferred stock. The warrants provided the holder
the option to purchase a specified number of shares of a particular series of the Company’s convertible preferred stock for a
specified price. The holder was permitted to exercise the warrant in cash or exercise pursuant to a cashless exercise whereby a
calculated number of shares would be withheld upon exercise to satisfy the cost of the exercise.
In accordance with their terms, in connection with the IPO, all outstanding warrants to purchase shares of convertible preferred
stock became exercisable for shares of common stock at a rate of one common stock warrant for every 1.219 preferred stock
warrants. Exercise prices of the warrants were also adjusted upon conversion by multiplying each of the exercise prices by
1.219. Immediately prior to the closing of the IPO, certain outstanding warrants to purchase shares of Series F convertible
redeemable preferred stock were net exercised for an aggregate of 27,207 shares of common stock.
In accordance with ASC 480-10, Distinguishing Liabilities from Equity, the Company accounted for preferred stock warrants
outstanding as a liability at fair value and adjusted the instruments to fair value at each reporting period. This liability was
subject to re-measurement at each balance sheet date until exercised, and any change in fair value was recognized in the
Company’s statements of operations and comprehensive (loss) income as other income (expense), net.
In connection with the preferred stock warrants becoming exercisable for common stock, the Company reclassified the
preferred stock warrant liability balance to additional paid-in capital effective July 29, 2019 due to meeting the criteria under
U.S. GAAP for classification in stockholders’ equity. See Note 12 for additional information on common stock warrants.
12. Stockholders’ Equity
Capital Stock
The Company’s Amended and Restated Certificate of Incorporation, dated July 29, 2019, authorizes the Company to issue up to
200,000,000 shares of common stock with a par value of $0.001 per share. The Company is also authorized to issue up to
F-23
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
10,000,000 shares of preferred stock with a par value of $0.001 per share. No dividends were declared or paid during the years
ended December 31, 2020 or 2019.
On July 11, 2019, the Company effected a 1-for-1.219 reverse stock split of its common stock. The par value and the authorized
number of shares of the common stock were not affected by the reverse stock split. The reverse stock split resulted in an
adjustment to the preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock
to be issued upon conversion. The accompanying financial statements and notes to the financial statements give retroactive
effect to the reverse stock split.
On July 29, 2019, the Company completed the initial public offering of its common stock. In connection with the IPO, the
Company issued and sold 4,600,000 shares of its common stock, including 600,000 shares associated with the full exercise of
the underwriters’ option to purchase additional shares, at a price to the public of $16.00 per share. The Company received
approximately $65.9 million in net proceeds from the IPO, after deducting underwriting discounts and commissions and other
offering expenses payable by the Company.
On June 29, 2020 and July 2, 2020, the Company issued and sold 2,000,000 and 300,000 shares, respectively, of its common
stock in a follow-on public offering at a price of $37.00 per share. The Company received $79.5 million in aggregate net
proceeds, after deducting underwriting discounts and commissions and offering costs. The shares issued and sold on July 2,
2020 reflect the underwriters’ exercise in full of their 30-day option to purchase additional shares at the public offering price,
less underwriting discounts and commissions.
On December 18, 2020, the Company issued and sold 4,600,000 shares of its common stock in a follow-on public offering,
including 600,000 shares associated with the full exercise of the underwriters’ option to purchase additional shares, at a price to
the public of $58.00 per share. The Company received $250.5 million in aggregate net proceeds, after deducting underwriting
discounts and commissions and offering costs (excluding $0.4 million in offering costs that were incurred but not paid as of
December 31, 2020).
Common Stock Warrants
The Company issued an aggregate of 51,238 shares, 209,238 shares and 31,814 shares of common stock on November 29,
2019, December 11, 2020 and December 29, 2020, respectively, pursuant to net exercises by the holders of common stock
warrants outstanding. In accordance with the net exercise provisions of the warrants, shares of common stock were withheld to
satisfy the cost of these exercises.
There were no common stock warrants outstanding as of December 31, 2020. Information about common stock warrants
outstanding as of December 31, 2019 is presented in the table below:
Expiration date
July 12, 2026
March 31, 2027
November 30, 2028
Total
As of December 31,
2019
Number
of shares
Exercise
price
209,243 $ 0.001
26,428 $ 7.10
8,809 $ 7.10
244,480
The common stock warrants were classified as stockholders’ equity and no adjustments were recorded for changes in fair value.
13. Stock Incentive Plans and Stock-Based Compensation
Stock Incentive Plans
The Company’s stock incentive plans provide for the granting of options to purchase common stock and other equity-based
awards to employees, directors and consultants of the Company. On September 6, 2008, the Company adopted the 2008 Stock
Plan (the “2008 Plan”), on August 15, 2018, the Company adopted the 2018 Stock Plan (the “2018 Plan”) and on July 24, 2019,
the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”). Following the adoption of the 2018 Plan, no additional
stock awards were granted under the 2008 Plan and following the adoption of the 2019 Plan, no additional stock awards were
granted under the 2018 Plan.
F-24
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Options under the plans may be granted as incentive stock options (“ISOs”) or non-statutory stock options (“NSOs”). ISOs may
only be granted to Company employees (including directors who are also considered employees). NSOs may be granted to
Company employees, directors and consultants. Options may be granted for terms up to ten years from the date of grant, as
determined by the Board of Directors; provided, however, that with respect to an ISO granted to a person who owns stock
representing more than 10% of the voting power of all classes of stock of the Company, the terms shall be for no more than five
years from the date of grant. The exercise price of options granted must be no less than 100% of the fair market value of the
shares on the date of grant, provided, however, that with respect to an ISO granted to an employee who at the time of grant of
such options owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise
price shall not be less than 110% of the fair market value of the shares on the date of grant. Options generally vest over four
years (generally 25% after one year and monthly thereafter), subject to the option holder’s continued service with the Company.
The Company issues new shares to satisfy option exercises.
On July 11, 2019, the Company’s Board of Directors approved an increase of 144,878 in the number of shares authorized for
issuance under the 2018 Plan.
On July 24, 2019, the 2019 Plan became effective. The 2019 Plan authorized 1,931,020 new shares plus the number of shares
(not to exceed 1,976,756 shares) that remained available under the 2018 Stock Plan at the time the 2019 Plan became effective
and any shares underlying outstanding stock awards granted under the 2018 Plan and 2008 Stock Plan that expire or are
repurchased, forfeited, cancelled or withheld. The 2019 Plan provides for automatic annual increases in the number of shares of
common stock reserved for issuance, which resulted in 856,545 additional shares becoming available effective January 1, 2020.
As of December 31, 2020, 366,452 shares remained available for grant under the 2019 Plan. On January 1, 2021, an additional
1,240,624 shares became available under the 2019 Plan pursuant to an automatic annual increase.
Stock Options
Stock option activity under the Company’s stock plans for the years ended December 31, 2020 and 2019 is set forth below:
Balance as of January 1, 2019
Granted
Exercised
Forfeited/Cancelled
Balance as of December 31, 2019
Granted
Exercised
Forfeited/Cancelled
Balance as of December 31, 2020
Exercisable at December 31, 2020(1)
Weighted-Average
Stock Options
Outstanding
Exercise
Price
Remaining
Contractual
Term (Years)
Aggregate
Intrinsic
Value
(in thousands)
1,659,596 $
1.99
1,711,325
(693,127)
(39,828)
19.41
1.70
6.36
2,637,966 $
13.30
1,286,065
(460,207)
(94,322)
3,369,502 $
49.63
3.53
27.51
28.11
824,128 $
10.67
8.72 $
7.54 $
131,525
46,546
(1) Vested and exercisable options. Additionally, outstanding unvested options to purchase an aggregate of 68,150 shares of common stock with a weighted-
average exercise price of $2.39 per share may be exercised prior to vesting as of December 31, 2020 under early-exercise provisions. In the event of such
exercise, the shares obtained upon exercise would be restricted and subject to forfeiture prior to vesting. No such early exercises have occurred as of
December 31, 2020.
F-25
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Restricted Stock Units
RSUs represent the right to receive shares of the Company’s common stock at a specified future date, subject to vesting. The
Company’s RSUs generally vest annually from the grant date in four equal installments subject to the holder’s continued
service with the Company. The Company issues new shares to satisfy RSUs upon vesting.
The following table summarizes the Company’s RSU activity for the year ended December 31, 2020:
Balance as of December 31, 2019
Granted
Vested
Forfeited/Cancelled
Balance as of December 31, 2020
Employee Stock Purchase Plan
Restricted
Stock Units
Outstanding
Weighted-
Average Grant
Date Fair Value
— $
161,477
—
—
—
59.16
—
—
161,477 $
59.16
The ESPP became effective July 24, 2019. The ESPP provides for automatic annual increases in the number of shares of
common stock reserved for issuance, which resulted in 171,309 additional shares becoming available effective January 1, 2020.
On February 28, 2020 and August 31, 2020 the Company issued 39,987 and 41,467 shares, respectively, of its common stock
pursuant to scheduled purchases under the ESPP. As of December 31, 2020, 501,790 shares of common stock are reserved for
future issuance under the ESPP. On January 1, 2021, an additional 248,124 shares became available under the ESPP pursuant to
an automatic annual increase.
The Company commenced a series of offerings under the ESPP on October 1, 2019. The initial offering began October 1, 2019,
ends on August 31, 2021 (unless terminated earlier, as described below) and consists of four purchase periods. The purchase
periods end on the last trading day of February and August 31 of each year. Eligible employees who enroll in the initial offering
or any subsequent offering will be able to purchase shares of the Company’s common stock at a discount through payroll
deductions, subject to certain limitations. The purchase price of the shares of common stock is the lesser of (i) 85% of the fair
market value of such shares on the offering date and (ii) 85% of the fair market value of such shares on the purchase date.
Following the commencement of the initial offering, new 24-month offerings, each with four six-month purchase periods,
automatically begin approximately every six months. Offerings are concurrent, but in the event the fair market value of a share
of common stock on the first day of any purchase period during an offering (the “New Offering”) is less than or equal to the fair
market value of a share of common stock on the offering date for an ongoing offering (the “Ongoing Offering”), then the
Ongoing Offering terminates immediately following the purchase of shares on the purchase date immediately preceding the
New Offering and the participants in the terminated Ongoing Offering are automatically enrolled in the New Offering. In such
case, the Company would account for this event as a modification of the Ongoing Offering. Notwithstanding the above, the
Company’s Board of Directors (or an authorized committee thereof) may modify the terms of or suspend any future offerings
prior to their commencement. As of December 31, 2020, there were three offerings outstanding under the ESPP. The Company
issues new shares for purchases of stock made pursuant to the ESPP.
Determining Fair Value - Summary of Assumptions
The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options and purchase rights
granted under the ESPP at the date of grant, start of the offering or other relevant measurement date. Following is a description
of the significant assumptions used in the option pricing model:
•
•
Expected term. The expected term is the period of time that granted options are expected to be outstanding. For stock
options, the Company has set the expected term using the simplified method based on the weighted average of both the
period to vesting and the period to maturity for each option, as the Company has concluded that its stock option
exercise history does not provide a reasonable basis upon which to estimate the expected term. For the ESPP, the
expected term is the period of time from the offering date to the purchase date.
Expected volatility. Because of the limited period of time the Company’s stock has been traded in an active market, the
Company calculates volatility by using the historical stock price volatility of a group of similar companies looking
back over the estimated life of the option or the ESPP purchase right and averaging the volatilities of these companies.
F-26
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
•
•
Risk-free interest rate. The Company bases the risk-free interest rate used in the Black-Scholes valuation model on the
market yield in effect at the time of option grant and at the offering date for the ESPP, provided from the Federal
Reserve Board’s Statistical Releases and historical publications from the Treasury constant maturities rates for the
equivalent remaining terms.
Dividend yield. The Company has not paid, and does not have plans to pay, cash dividends. Therefore, the Company
use an expected dividend yield of zero in the Black-Scholes option valuation model.
The fair value of the Company’s common stock is also an assumption used to determine the fair value of stock options. Prior to
the IPO, our common stock was not publicly traded, therefore the Company estimated the fair value of its common stock.
Following the IPO, the fair value of the Company’s common stock is the closing selling price per share of its common stock as
reported on the Nasdaq Global Market on the date of grant or other relevant determination date.
The Company uses the Black-Scholes option pricing model to estimate the fair value of each option grant on the date of grant or
any other measurement date. The following table sets forth the assumptions used to determine the fair value of stock options:
Average expected term (years)
Expected stock price volatility
Risk-free interest rate
Dividend yield
Years Ended December 31,
2020
6
2019
6
59.57% - 67.02% 56.74%- 60.17%
0.28% - 1.76%
1.63% - 2.47%
—%
—%
The following table sets forth assumptions used to determine the fair value of the purchase rights issued under the ESPP:
Average expected term (years)
Expected stock price volatility
Risk-free interest rate
Dividend yield
Years Ended December 31,
2020
1.2
2019
1.2
56.80% - 100.49% 61.12% - 68.89%
0.12% - 0.95%
1.56% - 1.80%
—%
—%
The Company uses the closing price of its common stock on the date of grant to determine the fair value of RSUs.
Stock-Based Compensation Expense
Stock-based compensation expense is included in the statements of operations and comprehensive (loss) income as follows (in
thousands):
Cost of sales
Research and development
Selling, general and administrative
Total stock-based compensation expense
Years Ended December 31,
2020
2019
$
$
1,049 $
1,492
5,768
170
165
914
8,309 $
1,249
For the years ended December 31, 2020 and 2019, the weighted-average grant date fair value of stock options was $28.95 and
$10.89 per option, respectively, and the weighted-average grant date fair value of the purchase rights granted under the ESPP
was $17.43 and $7.32 per share, respectively. As of December 31, 2020, the total unrecognized stock-based compensation cost
related to outstanding awards was $57,120,000, which is expected to be recognized on a straight-line basis over a weighted-
average period of 3.4 years. The total unrecognized compensation cost will be adjusted for forfeitures in future periods as they
occur. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2020 and 2019 was
$18,377,000 and $5,151,000, respectively. The aggregate intrinsic value of shares issued under the ESPP was $1,797,000
F-27
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
during the year ended December 31, 2020. There were no shares issued under the ESPP during the year ended December 31,
2019. No tax benefits related to stock-based compensation were recorded in the statements of operations and comprehensive
(loss) income during the years ended December 31, 2020 and 2019 due to the valuation allowance on net deferred tax assets.
14. Income Taxes
The components of income tax expense are as follows (in thousands):
Current tax expense
U.S. Federal
State and local
Total current
Deferred tax expense
U.S. Federal
State and local
Total deferred
Total income tax expense
Years Ended December 31,
2020
2019
$
— $
84
84
—
—
—
$
84 $
—
72
72
—
—
—
72
The differences between income taxes expected at the U.S. federal statutory rate (21%) and the reported income tax expense are
summarized as follows (in thousands):
Pre-tax (loss) income
U.S. federal taxes at statutory rate
State income taxes
Mark-to-market losses
Non-deductible meals
Convertible debt interest
Research and development (“R&D”) tax credit
Change in valuation allowance
Stock-based compensation
Non-deductible officers’ compensation
Other
Total income tax expense
Years Ended December 31,
2020
2019
$
(10,200) $
5,349
(2,142)
(311)
—
235
—
(703)
2,784
(781)
963
39
84 $
1,123
958
566
224
95
(251)
(2,747)
65
—
39
72
$
F-28
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
Significant components of deferred tax assets and liabilities are as follows (in thousands):
As of December 31,
2020
2019
Deferred tax assets:
Net operating loss (“NOL”) carryforwards
$
13,720 $
Accounts payable
Accrued liabilities
R&D tax credit
Intangible assets
Stock-based compensation
Charitable contributions
Total deferred tax assets
Less valuation allowance
Deferred tax assets, net
Deferred tax liabilities:
Accounts receivable
Prepaid expenses
Property and equipment
Section 481(a) adjustment (cash to accrual)
Total deferred tax liabilities
Net deferred tax asset (liability)
$
$
$
—
2,730
1,777
46
761
—
19,034
(15,204)
3,830 $
14,077
456
1,817
993
50
127
2
17,522
(12,420)
5,102
— $
(3,796)
(289)
(776)
(2,765)
(3,830)
— $
(757)
(246)
(303)
(5,102)
—
At December 31, 2020, the Company had NOL carryforwards for federal income tax purposes of approximately $55,851,000 of
which $41,958,000 will begin to expire in 2033 if not utilized to offset taxable income, and $13,893,000 may be carried
forward indefinitely. Future changes in ownership, as defined by Section 382 of the IRC, could limit the amount of NOL
carryforwards used in any one year. Also, as of December 31, 2020, the Company had state net operating loss carryforwards of
approximately $41,551,000, which begin to expire in 2028 if not utilized to offset state taxable income.
In general, under Section 382 and 383 of the IRC, a corporation that undergoes an “ownership change” is subject to limitations
on its ability to utilize its pre-change NOLs and certain tax credits, to offset future taxable income and tax. In general, an
ownership change occurs if the aggregate stock ownership of certain stockholders changes by more than 50 percentage points
over such stockholders’ lowest percentage of ownership during the testing period (generally three years). The Company
performed a Section 382 analysis from inception through the year ended December 31, 2020 and concluded the Company had
experienced an ownership change in 2011, 2014 and 2020. These changes in ownership did not result in the expiration of any
NOLs or R&D credits. However, future changes in ownership may further limit the ability of the Company to utilize its NOL
carryforwards and R&D tax credit carryforwards.
At December 31, 2020 and 2019, the Company placed a valuation allowance of $15,204,000 and $12,420,000, respectively,
against the entirety of its net deferred tax asset balance, as the Company has not determined that it is more likely than not to be
realized.
The Company assessed whether it had any significant uncertain tax positions related to open tax years and concluded there were
none. Accordingly, no reserve for uncertain tax positions has been recorded as of December 31, 2020 and 2019. The Company
is generally no longer subject to tax examinations for U.S. federal income tax purposes for fiscal years prior to 2017 and fiscal
years prior to 2015 for multiple state jurisdictions. However, since the Company has been in an NOL position since 2008, the
Company’s 2008 to 2016 federal tax returns and its 2008 to 2014 state tax returns are potentially subject to examination
adjustments to the extent of those NOL carryforwards.
F-29
CASTLE BIOSCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS (Continued)
15. Selected Quarterly Financial Data (Unaudited)
The following is a summary of selected unaudited quarterly financial data for the years ended December 31, 2020 and 2019 (in
thousands, except per share data):
Year Ended December 31, 2020
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Total Year
Net revenues
Gross margin
Net income (loss)(1)
Net income (loss) attributable to common
stockholders(1)
Earnings (loss) per share(3):
Basic
Diluted
$
$
$
$
$
$
17,418 $
12,715 $
15,217 $
17,299 $
15,027 $
10,569 $
12,742 $
14,626 $
62,649
52,964
570 $
(1,376) $
(4,589) $
(4,889) $
(10,284)
570 $
(1,376) $
(4,589) $
(4,889) $
(10,284)
0.03 $
0.03 $
(0.08) $
(0.08) $
(0.23) $
(0.23) $
(0.23) $
(0.23) $
(0.54)
(0.54)
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
Total Year
Year Ended December 31, 2019
Net revenues
Gross margin
Net (loss) income(2)
Net (loss) income attributable to common
stockholders(2)
(Loss) Earnings per share(3):
Basic
Diluted
$
$
$
$
$
$
8,717 $
7,119 $
10,739 $
14,774 $
17,635 $
8,746 $
13,066 $
15,624 $
(1,358) $
(1,269) $
5,849 $
2,055 $
51,865
44,555
5,277
(2,342) $
(2,265) $
5,543 $
2,055 $
2,991
(1.22) $
(1.22) $
(1.05) $
(1.05) $
0.43 $
0.05 $
0.12 $
0.11 $
0.35
(0.21)
(1) For the second, third and fourth quarters of 2020, includes other operating income (loss) of $1.9 million, ($1.9 million) and $1.9 million, respectively,
associated with CARES Act provider relief funds, as discussed in Note 2 to the financial statements. For the fourth quarter of 2020, includes a loss on
extinguishment of debt of $1.4 million.
(2) For the third quarter of 2019, includes a gain on extinguishment of debt of $5.2 million.
(3) Basic and diluted (loss) earnings per share are computed independently for each quarterly and annual period presented. Therefore, the sum of the quarterly
basic and diluted (loss) earnings per share amounts may not equal annual basic and diluted (loss) earnings per share.
F-30
STOCKHOLDER
INFORMATION
Offices
Biosciences,
Friendswood
Texas
Corporate
Castle
505
S.
Friendswood,
866.788.9007
Inc.
Drive,
77546
Suite
401
of
at 11:00
Meeting
2021,
Stockholders
(local
a.m.
Annual
June
10,
The San Luis Resort, Spa & Conference Center
5222
Galveston,
Seawall Boulevard
Texas 77551
time)
Registered
Public
Accounting
Firm
Independent
KPMG
San
LLP
Diego,
California
Issuer
Agent
Corporate
Transfer
Broadridge
P.O.
Box
Brentwood,
877.830.4936
shareholder@broadridge.com
11717
1342
New
York
Solutions,
Inc.
Zuckero
Contact
Investor
Camilla
Investor
Director,
Executive
Communications
Corporate
IR@castlebiosciences.com
Relations
&
common
stock
is
Exchange
Our
Nasdaq
ticker
symbol
Global
Market
‘‘CSTL’’.
traded
under
on
the
The
Forward-Looking
any
annual
federal
could
by
on
Note
Statements
This
looking
of
the
results
implied
statements.
‘‘Special
Forward-Looking
2020
Annual
additional
intent
or
forward-looking
should
Note
See
not
report
statements
contains
within
forward-
securities
differ
the
laws.
materially
forward-looking
meaning
Actual
from
those
section
the
Regarding
titled
our
on
Report
information.
to
obligation
Statements’’
Form
We
update
statements,
in
10-K
disclaim
these
and
them.
rely
on
unduly
you
for
any
of
Board
M.
Daniel
Chairman,
Executive
Founder
G.
Mara
Managing
Managing
Directors
Bradbury
Castle
Chairman,
Biosciences,
Equillium,
Inc.
Inc.
and
Managing
Member,
BioBrit,
LLC
Aspinall
Director,
Member,
BlueStone
Health
Venture
Partners
Catalysts
Group
G.
Bradley
Cole
General
Former
Exact Sciences
Manager,
Corporation
Precision
Oncology,
C.
Joseph
Managing
III
Cook
Director,
Mountain
Group
Partners
Harrison
President
D.
Miles
Former
&
America,Galderma
General
Laboratories
L.P.
Manager
for
North
David
Partner,
Kabakoff,
Ph.D.
HealthQuest
Capital
J.
Derek
Founder,
Castle
Maetzold
President,
Biosciences,
CEO
Inc.
and
Director,
Executive
Derek
J.
Founder,
Officers
Maetzold
President,
CEO,
and
Director
Tobin W. Juvenal
Chief
Commercial Officer
Kristen M. Oelschlager, R.N.
Chief Operating Officer
Bernhard
Chief
E.
Business
Spiess
Officer
Frank
Chief
Stokes
Financial
Officer
505 S. Friendswood Drive, Suite 401
Friendswood, Texas 77546
866.788.9007
For more information, please visit:
www.castlebiosciences.com
BR14843C-0421-10KW